Food Plant Sanitation (Food Science and Technology)

FOOD PLANT SANITATION edited by Y. H. Hui Science Technology System West Sacramento, California, U.S.A. Bernard L. Bru...

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FOOD PLANT SANITATION edited by

Y. H. Hui Science Technology System West Sacramento, California, U.S.A.

Bernard L. Bruinsma Innovative Cereal Systems Wilsonville, Oregon, U.S.A.

J. Richard Gorham Consultant Xenia, Ohio, U.S.A.

Wai-Kit Nip University of Hawaii at Manoa Honolulu, Hawaii, U.S.A.

Phillip S.Tong California Polytechnic State University San Luis Obispo, California, U.S.A.

Phil Ventresca E.S.I. Qual International Stoughton, Massachusetts, U.S.A.

Marcel Dekker, Inc.

New York • Basel

TM

Copyright © 2002 by Marcel Dekker, Inc. All Rights Reserved. © 2003 by Marcel Dekker, Inc.

© 2003 by Marcel Dekker, Inc.

ISBN: 0-8247-0793-1 This book is printed on acid-free paper. Headquarters Marcel Dekker, Inc. 270 Madison Avenue, New York, NY 10016 tel: 212-696-9000; fax: 212-685-4540 Eastern Hemisphere Distribution Marcel Dekker AG Hutgasse 4, Postfach 812, CH-4001 Basel, Switzerland tel: 41-61-260-6300; fax: 41-61-260-6333 World Wide Web http:/ /www.dekker.com The publisher offers discounts on this book when ordered in bulk quantities. For more information, write to Special Sales/Professional Marketing at the headquarters address above. Copyright  2003 by Marcel Dekker, Inc. All Rights Reserved. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microﬁlming, and recording, or by any information storage and retrieval system, without permission in writing from the publisher. Current printing (last digit): 10 9 8 7 6 5 4 3 2 1 PRINTED IN THE UNITED STATES OF AMERICA

© 2003 by Marcel Dekker, Inc.

Preface

As food professionals, we have noticed the monumental increase in awareness of food safety in the past decade. Professionally, this awareness manifests itself in many ways, with educational materials (print, Internet, videos, etc.) heading the list. Reference books on food safety are especially useful. This book has three important goals: (1) to present the fundamental principles of food plant sanitation and their applications in the food industry; (2) to provide professionals with basic, hands-on information for the day-to-day operations in a food processing plant, (3) to review some of the industry’s most recent developments. To achieve these goals, the book covers nine major areas: federal and state regulations and guidelines, major biological and nonbiological contaminants, cleaning a food plant, sanitation and worker safety, housekeeping, product quality, commodity processing, retail food sanitation, and enforcement. The book covers both basic sanitation practices and the latest information on the Hazard Analysis Critical Control Point (HACCP) program. However, HACCP is discussed as a peripheral consideration. Before one considers HACCP, one must make sure that each food processing plant has put in place an acceptable sanitation program in principle and in practice: Have the incoming raw materials been checked? Is there water (or debris) on the ﬂoor of the operations room? Does every worker wear a hairnet when handling food products or ingredients? Is the cold storage room maintained at the required temperature? Are there rat and bird droppings in the plant? There are these questions and more to consider. This book differs from other food sanitation books in that its presentation is a compilation of multiple perspectives from more than 30 government, academia, and industry © 2003 by Marcel Dekker, Inc.

food safety experts. They cover more than 40 topics in food plant sanitation and HACCP and present the latest developments in retail food processing and sanitation. Last, but not least, the book provides examples of the enforcement activities of the U.S. Food and Drug Administration (FDA) in relation to food plant sanitation. The discussion is accompanied by a reproduction of the FDA’s Handbook of Food Defect Action Levels in the appendix. In sum, the approach for this book is unique and makes it an essential reference for the food safety and quality professional. The editorial team thanks all the contributors for sharing their experience in their ﬁelds of expertise. They are the people who made this book possible. We hope you enjoy and beneﬁt from the fruits of their labor. We know how hard it is to develop the content of a book. However, we believe that the production of a professional book of this nature is even more difﬁcult. We thank the production team at Marcel Dekker, Inc., and express our appreciation to Ms. Theresa Stockton, coordinator of the entire project. Y. H. Hui Bernard L. Bruinsma J. Richard Gorham Wai-Kit Nip Phillip S. Tong Phil Ventresca

© 2003 by Marcel Dekker, Inc.

Contents

Preface PART I.

PRINCIPLES OF FOOD PLANT SANITATION

1. An Overview of FDA’s Food Regulatory Responsibilities Y. H. Hui 2. Foodborne Diseases in the United States P. Michael Davidson 3. The FDA’s GMPs, HACCP, and the Food Code Y. H. Hui, Wai-Kit Nip, and J. Richard Gorham 4. Food Plant Inspections Alfred J. St. Cyr PART II.

FOOD CONTAMINANTS

5. Hard or Sharp Foreign Objects in Food Alan R. Olsen and Michael L. Zimmerman © 2003 by Marcel Dekker, Inc.

003 by Marcel Dekker, Inc.

6.

Filth and Extraneous Material in Food Michael L. Zimmerman, Alan R. Olsen, and Sharon L. Friedman

7.

Food Defect Action Levels John S. Gecan

8.

Analysis of Drug Residues in Food Sherri B. Turnipseed

PART III. CLEANING A FOOD PLANT 9.

Cleaning and Sanitizing a Food Plant Peggy Stanﬁeld

10.

Water in Food Processing Chun-Shi Wang, James Swi-Bea Wu, and Philip Cheng-Ming Chang

11.

Water and HACCP Programs Yu-Ping Wei, James Swi-Bea Wu, and Philip Cheng-Ming Chang

12.

Water Use in the Beverage Industry Daniel W. Bena

13.

Sanitation of Food Processing Equipment Peggy Stanﬁeld

PART IV. WORKERS IN A FOOD PROCESSING PLANT 14.

Workers’ Personal Hygiene Tin Shing Chao

15.

Worker Safety and Regulatory Requirements Tin Shing Chao

16.

Worker Training in Sanitation and Personal Safety Tin Shing Chao

17.

Worker Safety and Types of Food Establishments Peggy Stanﬁeld

PART V. HOUSEKEEPING IN A FOOD PROCESSING PLANT 18.

Rodent Pest Management Robert M. Corrigan

© 2003 by Marcel Dekker, Inc.

19. Insects and Mites Linda Mason 20. Pest Birds: Biology and Management at Food Processing Facilities John B. Gingrich and Thomas E. Osterberg 21. Stored-Product Insect Pest Management and Control Franklin Arthur and Thomas W. Phillips PART VI. QUALITY ASSURANCE PROGRAMS 22. An Informal Look at Food Plant Sanitation Programs Jerry W. Heaps 23. Sanitation and Warehousing Y. H. Hui, Wai-Kit Nip, and J. Richard Gorham 24. Metal Detection Andrew Lock 25. Packaging Michael A. Mullen and Sharon V. Mowery PART VII. HACCP AND PRODUCT PROCESSING 26. Beverage Plant Sanitation and HACCP Henry C. Carsberg 27. Cereal Food Plant Sanitation Gregory A. Umland, A. Jay Johnson, and Cheryl Santucci 28. Plant Sanitation and HACCP for Fruit Processing Andi Shau-mei Ou, Wen-zhe Hwang, and Sheng-dun Lin 29. Sanitation in Grain Storage and Handling Michael D. Toews and Bhadriraju Subramanyam 30. Sanitation and Safety for a Fats and Oils Processing Plant Richard D. O’Brien 31. Poultry Processing, Product Sanitation, and HACCP T. C. Chen and Ping-Lieh Thomas Wang 32. Seafood Processing: Basic Sanitation Practices Peggy Stanﬁeld © 2003 by Marcel Dekker, Inc.

PART VIII. RETAIL FOOD SANITATION 33.

Retail Foods Sanitation: Prerequisites to HACCP Peggy Stanﬁeld

34.

Retail Food Processing: Reduced Oxygen Packaging, Smoking, and Curing Y. H. Hui

PART IX. FEDERAL ENFORCEMENT AND FOOD SAFETY PROGRAMS 35.

FDA Enforcement and Food Plant Sanitation Peggy Stanﬁeld

36.

A Review of U.S. Food Safety Policies and Programs Tin Shing Chao

Appendix A: U.S. Food and Drug Administration Good Manufacturing Practices Appendix B: Hazard Analysis and Critical Control Point Principles and Application Guidelines Appendix C: Food Code 2001 [Table of Contents] Appendix D: The Handbook of Food Defect Action Levels

© 2003 by Marcel Dekker, Inc.

Contributors

Franklin Arthur Grain Marketing and Production Research Center, U.S. Department of Agriculture, Manhattan, Kansas, U.S.A. Daniel W. Bena PepsiCo Beverages International, Purchase, New York, U.S.A. Henry C. Carsberg

Henry C. Carsberg & Associates, Anacortes, Washington, U.S.A.

Philip Cheng-Ming Chang versity, Keelung, Taiwan

Department of Food Science, National Taiwan Ocean Uni-

Tin Shing Chao Hawaii Occupational Safety and Health Division, U.S. Department of Labor, Honolulu, Hawaii, U.S.A. T. C. Chen Poultry Science Department, Mississippi State University, Mississippi State, Mississippi, U.S.A. Robert M. Corrigan

RMC Pest Management Consulting, Richmond, Indiana, U.S.A.

P. Michael Davidson Department of Food Science and Technology, University of Tennessee, Knoxville, Tennessee, U.S.A. Sharon L. Friedman Center for Veterinary Medicine, U.S. Food and Drug Administration, Laurel, Maryland, U.S.A. © 2003 by Marcel Dekker, Inc.

John S. Gecan* Microanalytical Branch, U.S. Food and Drug Administration, Washington, D.C., U.S.A. John B. Gingrich Department of Entomology and Applied Ecology, University of Delaware, Newark, Delaware, U.S.A. J. Richard Gorham Consultant, Xenia, Ohio, U.S.A. Jerry W. Heaps General Mills, Minneapolis, Minnesota, U.S.A. Y. H. Hui Science Technology System, West Sacramento, California, U.S.A. Wen-zhe Hwang Department of Food Science, National Chung Hsing University, Taichung, Taiwan A. Jay Johnson Ringger Foods, Inc., Gridley, Illinois, U.S.A. Sheng-dun Lin Department of Food and Nutrition, Hungkuang Institute of Technology, Taichung, Taiwan Andrew Lock Safeline, Inc., Tampa, Florida, U.S.A. Linda Mason U.S.A.

Department of Entomology, Purdue University, West Lafayette, Indiana,

Sharon V. Mowery Department of Entomology, Kansas State University, Manhattan, Kansas, U.S.A. Michael A. Mullen Grain Marketing and Production Research Center, Agricultural Research Service, U.S. Department of Agriculture, Manhattan, Kansas, U.S.A. Wai-Kit Nip Department of Molecular Biosciences and Bioengineering, University of Hawaii at Manoa, Honolulu, Hawaii, U.S.A. Richard D. O’Brien Fats and Oils Consultant, Plano, Texas, U.S.A. Alan R. Olsen Microanalytical Branch, U.S. Food and Drug Administration, Washington, D.C., U.S.A. Thomas E. Osterberg General Mills, Golden Valley, Minnesota, U.S.A. Andi Shau-mei Ou Department of Food Science, National Chung Hsing University, Taichung, Taiwan

* Retired.

© 2003 by Marcel Dekker, Inc.

Thomas W. Phillips Department of Entomology and Plant Pathology, Oklahoma State University, Stillwater, Oklahoma, U.S.A. Alfred J. St. Cyr AIB International, Manhattan, Kansas, U.S.A. Cheryl Santucci Ringger Foods, Inc., Gridley, Illinois, U.S.A. Peggy Stanﬁeld

Dietetic Resources, Twin Falls, Idaho, U.S.A.

Bhadriraju Subramanyam Department of Grain Science and Industry, Kansas State University, Manhattan, Kansas, U.S.A. Michael D. Toews Department of Grain Science and Industry, Kansas State University, Manhattan, Kansas, U.S.A. Sherri B. Turnipseed Animal Drugs Research Center, U.S. Food and Drug Administration, Denver, Colorado, U.S.A. Gregory A. Umland Ringger Foods, Inc., Gridley, Illinois, U.S.A. Chun-Shi Wang Institute of Food Science and Technology, National Taiwan University, Taipei, Taiwan Ping-Lieh Thomas Wang Fieldale Farms Corporation, Baldwin, Georgia, U.S.A. Yu-Ping Wei Institute of Food Science and Technology, National Taiwan University, Taipei, Taiwan James Swi-Bea Wu Institute of Food Science and Technology, National Taiwan University, Taipei, Taiwan Michael L. Zimmerman U.S. Food and Drug Administration, Albuquerque, New Mexico, U.S.A.

© 2003 by Marcel Dekker, Inc.

1 An Overview of FDA’s Food Regulatory Responsibilities Y. H. HUI Science Technology System, West Sacramento, California, U.S.A.

This chapter provides a summary of the legal requirements affecting manufacture and distribution of food products within and those imported into the United States. The last chapter in this book further expands the data. The United States Food and Drug Administration (FDA) has provided a description of these requirements to the public at large. The information has been translated into several languages and it is reproduced below with some minor updating by the author. The FDA regulates all food and food-related products, except commercially processed egg products and meat and poultry products, including combination products (e.g., stew, pizza), containing 2% or more poultry or poultry products or 3% or more red meat or red meat products, which are regulated by the United States Department of Agriculture’s Food Safety and Inspection Service (FSIS). Fruits, vegetables, and other plants are regulated by the that department’s Animal and Plant Health Inspection Service (APHIS) to prevent the introduction of plant diseases and pests into the United States. The voluntary grading of fruits and vegetables is carried out by the Agricultural Marketing Service (AMS) of the USDA. All nonalcoholic beverages and wine beverages containing less than 7% alcohol are the responsibility of FDA. All alcoholic beverages, except wine beverages (i.e., fermented fruit juices) containing less than 7% alcohol, are regulated by the Bureau of Alcohol, Tobacco, and Firearms of the Department of Treasury. In addition, the Environmental Protection Agency (EPA) regulates pesticides. The EPA determines the safety of pesticide products, sets tolerance levels for pesticide residues in food under a section of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and © 2003 by Marcel Dekker, Inc.

publishes directions for the safe use of pesticides. It is the responsibility of FDA to enforce the tolerances established by EPA. Within the United States, compliance with the FD&C Act is secured through periodic inspections of facilities and products, analyses of samples, educational activities, and legal proceedings. A number of regulatory procedures or actions are available to FDA to enforce the FD&C Act and thus help protect the public’s health, safety, and wellbeing. Adulterated or misbranded food products may be voluntarily destroyed or recalled from the market by the shipper, or may be seized by U.S. marshals on orders obtained by FDA from federal district courts. Persons or ﬁrms responsible for violation may be prosecuted in the federal courts and if found guilty may be ﬁned and/or imprisoned. Continued violations may be prohibited by federal court injunctions. The violation of an injunction is punishable as contempt of court. Any or all types of regulatory procedures may be employed, depending upon the circumstances. A recall may be voluntarily initiated by the manufacturer or shipper of the food commodity or at the request of FDA. Special provisions on recalls of infant formulas are in the FD&C Act. While the cooperation of the producer or shipper with FDA in a recall may make court proceedings unnecessary, it does not relieve the person or ﬁrm from liability for violations. It is the responsibility of the owner of the food in interstate commerce to ensure that the article complies with the provisions of the FD&C Act, the Fair Packaging and Labeling Act (FPLA), and their implementing regulations. In general, these acts require that the food product be a safe, clean, wholesome product and its labeling be honest and informative. The FD&C Act gives FDA the authority to establish and impose reasonable sanitation standards on the production of food. The enclosed copy of Title 21, Code of Federal Regulations, Part 110 (21 CFR 110) contains the current good manufacturing practice (GMP) regulations for manufacturing, packing, and holding human food concerning personnel, buildings and facilities, equipment, and product process controls, which, if scrupulously followed, may give manufacturers some assurance that their food is safe and sanitary. In 21 CFR 110.110, FDA recognizes that it is not possible to grow, harvest, and process crops that are totally free of natural defects. Therefore, the agency has published the defect actions for certain food products. These defect action levels are set on the basis of no hazard to health. In the absence of a defect action level, regulatory decisions concerning defects are made on a case-by-case basis. The alternative to establishing natural defect levels in food would be to insist on increased utilization of chemical substances to control insects, rodents, and other natural contaminants. The FDA has published ‘‘action levels’’ for poisonous or deleterious substances to control levels of contaminants in human food and animal feed. However, a court in the United States invalidated FDA’s action levels for poisonous or deleterious substances on procedural grounds. In the interim we are using their ‘‘Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed’’ as guidelines which do not have the force and effect of law. The Agency has made it clear that action levels are procedural guidelines rather than substantive rules. The FDA does not approve, license, or issue permits for domestic products shipped in interstate commerce. However, all commercial processors, whether foreign or domestic, of thermally processed low-acid canned foods (LACFs) packaged in hermetically sealed containers, or of acidiﬁed foods (AF-), are required by regulations to register each pro© 2003 by Marcel Dekker, Inc.

cessing plant. In addition, each process for a LACF or AF must be submitted to FDA and accepted for ﬁling by FDA before the product can be distributed in interstate commerce. A low-acid food is deﬁned as any food, other than alcoholic beverages with a ﬁnished equilibrium pH greater than 4.6 and a water activity greater than 0.85. Many canned food products are LACF products, and packers are therefore subject to the registration and processing ﬁling requirements. The only exceptions are tomatoes and tomato products having a ﬁnished equilibrium pH less than 4.7. An acidiﬁed food is a low-acid food to which acid(s) or acid food(s) are added resulting in a product having a ﬁnished equilibrium pH of 4.6 or below. The FDA’s LACF regulations require that each hermetically sealed container of a low-acid processed food shall be marked with an identifying code that shall be permanently visible to the naked eye. The required identiﬁcation shall identify, in code, the establishment where the product is packed, the product contained therein, the year and day of the pack, and the period during the day when the product was packed [21 CFR 113.60(c)]. There is no requirement that a product be shipped from the United States within a stipulated period of time from the date of manufacture. If a LACF or AF is properly processed, it would not require any special shipping or storage conditions. Regulations require that scheduled processes for LACFs shall be established by qualiﬁed persons having expert knowledge of thermal processing requirements for lowacid foods in hermetically sealed containers and having adequate facilities for making such determinations (21 CFR 113.83). All factors critical to the process are required to be speciﬁed by the processing authority in the scheduled process. The processor of the food is required to control all critical factors within the limits speciﬁed in the scheduled process. The FDA has the responsibility to establish U.S. identity, quality, and ﬁll of container standards for a number of food commodities. Food standards, which essentially are deﬁnitions of food content and quality, are established under provisions of the FD&C Act. Standards have been established for a wide variety of products. These standards give consumers some guarantee of the kind and amount of major ingredients in these products. A food which purports to be a product for which a food standard has been promulgated must meet that standard or it may be deemed to be out of compliance and, therefore, subject to regulatory action. Amendments to the FD&C Act establish nutrient requirements for infant formulas and provide FDA authority to establish good manufacturing practices and requirements for nutrient quantity, nutrient quality control, recordkeeping, and reporting. Under these amendments, FDA factory inspection authority was expanded to manufacturer’s records, quality control records, and test results necessary to determine compliance with the FD& C Act. The FDA has mandated Hazard Analysis Critical Control Point (HACCP) procedures for several food categories including seafood and selected fruit and vegetable products. Such procedures assure safe processing, packaging, storage, and distribution of both domestic and imported ﬁsh and ﬁshery products and fruit and vegetable products. The HACCP system allows food processors to evaluate the kinds of hazards that could affect their products, institute controls necessary to keep hazards from occurring, monitor the performance of the controls, and maintain records of this monitoring as a matter of routine practice. The purpose is to establish mandatory preventative controls to ensure the safety of the products sold commercially in the United States and exported abroad. The FDA will review the adequacy of HACCP controls in addition to its traditional inspection activities. © 2003 by Marcel Dekker, Inc.

The food labeling regulations found in 21 CFR 101 and 105 contain the requirements which when followed result in honest and informative labeling of food. Mandatory labeling of food includes a statement of identity (common or usual name of the product—21 (CFR 101.3); a declaration of net quantity of contents (21 CFR 101.105); the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5); and, if fabricated from two or more ingredients, each ingredient must be listed in descending order of predominance by its common or usual name (21 CFR 101.4 and 101.6). Spices, ﬂavoring, and some coloring, other than those sold as such, may be designated as spices, ﬂavoring, and coloring without naming each. However, food containing a color additive that is subject to certiﬁcation by FDA must be declared in the ingredients statement as containing that color. On January 6, 1993, the FDA issued ﬁnal rules concerning food labeling as mandated by the Nutrition Labeling and Education Act (NLEA). These rules, which are included in the enclosed food labeling booklet, signiﬁcantly revise many aspects of the existing food labeling regulations, mainly nutrition labeling and related claims for food. The NLEA regulations apply only to domestic food shipped in interstate commerce and to food products offered for import into the United States. The labeling of food products exported to a foreign country must comply with the requirements of that country. If the label on a food product fails to make all the statements required by the FD& C Act, the FPLA, and the regulations promulgated under these acts, or if the label makes unwarranted claims for the product, the food is deemed to be misbranded. The FD&C Act provides for both civil and criminal action for misbranding. The FPLA provides for seizure and injunction. The legal responsibility for full compliance with the terms of each of these acts and their regulations, as applied to labels, rests with the manufacturer, packer, or distributor when the goods are entered into interstate commerce. The label of a food product may include the Universal Product Code (UPC) as well as a number of symbols which signify that (1) the trademark is registered with the U.S. Patent Ofﬁce; (2) the literary and artistic content of the label is protected against infringement under the copyright laws of the United States; and (3) the food has been prepared and/or complies with dietary laws of certain religious groups. It is important to note that neither the UPC nor any of the symbols mentioned are required by, or are under the authority of, any of the acts enforced by the U.S. Food and Drug Administration. The FD&C Act requires premarket approval for food additives (substances whose use results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteristics of food). The approval process involves a very careful review of the additive’s safety for its intended use. Following the approval of a food additive, a regulation describing its use is published in the Code of Federal Regulations. As deﬁned in the CFR, the term safe or safety ‘‘means there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. It is impossible in the present state of scientiﬁc knowledge to establish with complete certainty the absolute harmlessness of the use of any substance. Premarket clearance under the FD&C Act does assure that the risk of adverse effects occurring due to a food additive is at an acceptably small level. The FDA’s regulation of dietary supplements is under the authority of the Dietary Supplements Health and Education Act of 1994. It ensures that the products are safe and properly labeled and that any disease or health-related claims are scientiﬁcally supported. The legal provisions governing the safety of dietary supplements depend on whether the © 2003 by Marcel Dekker, Inc.

product is legally a food or a drug. In either instance the manufacturer is obligated to produce a safe product. Premarket safety review by FDA is required for new drugs. The label of a dietary supplement is to state what the product contains, how much it contains, how it should be used, and precautions necessary to assure safe use with all other information being truthful and not misleading. If the dietary supplement is a food, a review of any disease or health-related claim is conducted under the NLEA health claim provisions. This book presents an important aspect of the stated requirements: the sanitation of an establishment that manufactures and distributes processed food.

© 2003 by Marcel Dekker, Inc.

2 Foodborne Diseases in the United States P. MICHAEL DAVIDSON University of Tennessee, Knoxville, Tennessee, U.S.A.

I.

INTRODUCTION

While food is an indispensable source of nutrients for humans, it is also a source of microorganisms. Microorganisms in foods may be one of three types: beneﬁcial, spoilage, or pathogenic. Beneﬁcial microorganisms include those that produce new foods or food ingredients through fermentations (e.g., lactic acid bacteria and yeasts) and probiotics. The second type are those that cause spoilage of foods. Spoilage may be deﬁned as an undesirable change in the ﬂavor, odor, texture, or color of food caused by growth of microorganisms and ultimately the action of their enzymes. The ﬁnal group are those microorganisms that cause disease. These microorganisms may grow in or be carried by foods. There are two types of pathogenic, or disease-causing, microorganisms: those causing intoxications and those causing infections. Intoxications are the result of a microorganism growing and producing toxin in a food. It is the toxin that causes the illness. Infections are illnesses that result from ingestion of a microorganism. Infectious microorganisms may cause illness by production of enterotoxins in the gastrointestinal tract or adhesion and/or invasion of the tissues. There are various types of pathogenic microorganisms that may be transmitted by foods including bacteria, viruses, protozoa, and helminths (Table 1). Certain molds (fungi) may also produce toxins (mycotoxins) in foods that are potentially toxic, carcinogenic, mutagenic, or teratogenic to humans and animals. Sources of these pathogenic microorganisms include soil, water, air, animals, plants, and humans. The U.S. Centers for Disease Control and Prevention (CDC) estimates that there are 6.5 to 76 million cases of foodborne illness per year in the United States [1]. The actual number of conﬁrmed cases documented by CDC is much lower (Table 2). The reason for the difference in estimated and conﬁrmed cases is that foodborne illnesses are © 2003 by Marcel Dekker, Inc.

Table 1

Primary Microbial Pathogens Associated with Food Products

Bacteria Aeromonas hydrophila Bacillus cereus Campylobacter jejuni Clostridium botulinum Clostridium perfringens Escherichia coli Listeria monocytogenes Salmonella Shigella Vibrio cholerae Vibrio parahaemolyticus Vibrio vulniﬁcus Yersinia enterocolitica

Protozoa

Nematodes

Viruses

Cryptosporidium parvum Cyclospora cayetanensis Giardia lamblia Toxoplasma gondii

Trichinella spiralis

Hepatitis A SRSV Calicivirus Astrovirus

often self-limited and non–life threatening. Therefore, affected persons often do not seek medical attention and their illnesses are not documented. To improve foodborne illness surveillance, CDC began a program in 1996 called FoodNet. Initially, surveillance included laboratory-conﬁrmed cases of Campylobacter, Escherichia coli O157, Listeria monocytogenes, Salmonella, Shigella, Vibrio, and Yersinia enterocolitica infections by clinical laboratories in Minnesota, Oregon, and selected counties in California, Connecticut, and Georgia. In 1997, surveillance was expanded to include Cryptosporidium and Cyclospora cayetanensis. By 2000, the surveillance area expanded to include all of Connecticut and Georgia and counties in Maryland, New York, and Tennessee. The FoodNet surveillance population is 29.5 million persons and represents 10.8% of the U.S. population. Cases represent isolation of a pathogen from a person by a clinical laboratory and are not necessarily linked to food sources. Data for the entire period of FoodNet surveillance are shown in Table 3. Disease incidence is related to susceptibility of the consuming population. Subpopulations at increased risk for foodborne illness include individuals under 5 years of age, Table 2 Conﬁrmed Cases and Deaths in the United States as Reported by the United States Centers for Disease Control and Prevention, 1973–1997 Bacteria Bacillus cereus Campylobacter Clostridium botulinum Clostridium perfringens Escherichia coli Listeria monocytogenes Salmonella Shigella Staphylococcus aureus Vibrio species Source: Refs. 6, 7, 8.

© 2003 by Marcel Dekker, Inc.

Outbreaks

Cases

Deaths

93 106 304 287 103 — 1,696 172 459 46

2,247 2,821 683 18,807 4,691 323 109,651 20,742 20,339 1,561

0 5 59 13 12 70 139 4 5 14

Table 3 Illnesses per 100,000 Population Detected by the Centers for Disease Control and Prevention’s Foodborne Active Surveillance Network (FoodNet) in the United States, 1996–2000 Microorganism

1996

1997

1998

1999

2000

Change

Campylobacter Cryptosporidium Cyclospora Escherichia coli O157 Listeria monocytogenes Salmonella Shigella Vibrio Yersinia

23.5 NR NR 2.7 0.5 14.5 8.9 0.2 1.0

25.2 3.7 0.4 2.3 0.5 13.6 7.5 0.3 0.9

21.4 2.9 0.1 2.8 0.6 12.3 8.5 0.3 1.0

17.5 1.8 0.1 2.1 0.5 13.6 5.0 0.2 0.8

20.1 2.4 0.1 2.9 0.4 12.0 11.6 0.3 0.5

⫺3.4 — — ⫹0.2 ⫺0.1 ⫺2.5 ⫹2.7 ⫹0.1 ⫺0.5

Source: Ref. 12.

over 60 years of age, immunocompromised individuals, those with chronic diseases, AIDS patients, and pregnant females. The immunocompromised include persons receiving immune suppressive drug treatments or antibiotic therapies and organ transplant patients. Chronic diseases predisposing persons to foodborne illness may include diabetes; asthma; and heart, liver, and intestinal diseases [1].

II. BACTERIAL FOODBORNE DISEASES A. Aeromonas hydrophila This microorganism occurs widely in nature, especially in water. As a result of its occurrence in water, it is also found in foods. The microorganism has been isolated from raw milk, cheese, ice cream, poultry, meats, fresh vegetables, ﬁnﬁsh, oysters, and other seafoods [2]. Aeromonas hydrophila is a facultatively anaerobic, gram-negative rod that is motile with a polar ﬂagellum. The microorganism has a temperature range of 4–5°C up to 42–43°C with an optimum of 28°C [2]. The pH range is 4.5–9.0 and the maximum concentration of salt for growth is 4%. It is pathogenic to ﬁsh, turtles, frogs, snails, alligators, and humans. Evidence suggests that A. hydrophila causes gastroenteritis in humans and infections in persons immunocompromised by treatment for cancer. Aeromonas hydrophila forms hemolysins, enterotoxins, and cytotoxins, all of which could be related to its pathogenicity. The microorganism has a D48°C of 5.2 min in saline and 4.3 min in raw milk with a z value of 6.21°C [2]. B. Bacillus cereus Bacillus cereus is a gram-positive, aerobic, sporeforming, rod-shaped bacteria. Most strains have an optimum temperature for growth of 30°C and a range of 15–55°C. Some strains are psychrotrophic and able to grow at 4–6°C. The normal habitat and/or distribution for B. cereus is dust, water, and soil. The bacterium may be found in many foods and food ingredients. Some other species of Bacillus have been associated with foodborne illness, including B. thuringiensis, B. subtilis, B. licheniformis, and B. pumilis [3]. © 2003 by Marcel Dekker, Inc.

Because the microorganism is a sporeformer, it is heat resistant. Most spores are of moderate heat resistance (D121°C of 0.3 min) but some have high heat resistance (D121°C of 2.35) [3,4]. The pH range for the microorganism is 5.0–8.8 and the water activity minimum is 0.93 depending upon acidulant and humectant, respectively. Bacillus cereus produces two types of gastroenteritis: emetic and diarrheal. The diarrheal syndrome (also called C. perfringens–like) is caused by an enterotoxin that is a vegetative growth metabolite formed in the intestine. The toxin is a protein (50 kDa) that is heat labile (56°C, 5 min) and trypsin sensitive. The illness onset for this syndrome is 8–16 hr and it has a duration of 6–24 hr. The symptoms include nausea, abdominal cramps, and diarrhea. Foods associated with the diarrheal syndrome include cereal dishes (corn and corn starch), mashed potatoes, vegetables, minced meat, liver sausage, meat loaf, milk and milk products, some rice dishes, puddings, and soups. The number of cells required for outbreak of this type of syndrome is 5–7 log CFU (colony forming unit) per gram of food [3]. The emetic syndrome (also called S. aureus–like) is caused by a cyclic polypeptide toxin which is much smaller (5000 Da) and may be preformed in certain foods [3]. As opposed to the diarrheal toxin, the emetic toxin is heat (⬎90 min at 121°C) and trypsin stable. The illness onset is very short, from 1 to 6 hr and the duration is ⬍24 hr. Symptoms include nausea and vomiting (more severe than diarrheal). The illness is not generally fatal, although there was a report of liver failure associated with the illness [5]. Foods associated with B. cereus emetic syndrome include primarily boiled or fried rice along with pasta, noodles, mashed potatoes, and vegetable sprouts. The number of cells required for an outbreak is ca. 8 log CFU/g. From 1983 to 1997, there were 93 conﬁrmed outbreaks and 2247 cases of B. cereus foodborne illness [6–8] in the United States. Most outbreaks involved Chinese food or fried rice. C.

Campylobacter

Campylobacter jejuni was ﬁrst recognized in 1913 as a disease in sheep and cattle. It was originally called Vibrio fetus. The human pathogens that are foodborne include C. jejuni, C. coli, C. lari, and C. upsaliensis [9]. The most common foodborne pathogens (⬎90% cases) are C. jejuni, C. coli, and C. lari. Campylobacter is a gram-negative, nonsporeforming, vibroid (helical, S-shaped, gull wing–shaped) rod (0.2–0.5 µm ⫻ 1.5–5.0 µm). It is motile by a single polar ﬂagellum. The microorganism is microaerophilic requiring 5% O2 and 10% CO2 [9]. The temperature for growth ranges from 30 to 45.5°C and its optimum is 37–42°C. The microorganism is associated with warm-blooded animals, especially poultry, and can be found in raw milk, insects, and water. Campylobacter jejuni is not extremely tolerant to environmental stresses. It survives to a maximum sodium chloride level of ⬍3.5% and is inhibited by 2.0%. It has a very low heat resistance. Heat injury occurs at 46°C and inactivation at 48°C. The microorganism has a D55°C of 0.64–1.09 min in 1% peptone and 2.12–2.25 min in chicken [4]. The pH range for growth of the microorganism is 4.9–9.0. Campylobacter jejuni survives for 2 weeks in milk at 4°C or water and meat at ⫺25°C. Campylobacter jejuni causes a gastroenteritis called campylobacteriosis that has an onset time of 2–5 days and has primary symptoms of severe diarrhea and abdominal pain. Fever and headache may also be present. The duration is ⬍1 week without treatment and the mortality rate is very low. An infectious dose may be as low as 500 cells [9]. The © 2003 by Marcel Dekker, Inc.

primary targets for C. jejuni are infants and young children under 5 years and those 20– 40 years old. Complications and sequelae of campylobacteriosis include relapse (5–10%), bacteremia, acute appendicitis, meningitis, urinary tract infections, endocarditis (primarily C. fetus), peritonitis, Reiter’s syndrome (see Sec. II.I) and Guillain–Barre´ Syndrome. The latter occurs in 0.2–2 cases per 1000 cases of campylobacteriosis and involves paralysis and demyelination of nerves [10]. The mechanism of pathogenicity is not entirely clear but may involve attachment, invasion of intestinal epithelia, and/or enterotoxin formation. Most cases of campylobacteriosis are sporadic, i.e., not associated with an outbreak. There have been few outbreaks documented by CDC. From 1973–1987, there were 53 outbreaks, 1547 cases, and two deaths in the United States [6]. From 1988–1997, there were also 53 outbreaks with 1274 cases and three deaths [7,8]. While there are a low number of conﬁrmed cases of campylobacteriosis, the epidemiological estimate of cases in the United States is 2.5 million annually [11], making it the most prevalent food poisoning microorganism. The FoodNet surveillance system revealed that campylobacteriosis occurs at a rate similar to or higher than salmonellosis (see Table 3) [12]. Foods involved in outbreaks of campylobacteriosis have primarily been raw milk. Up to 70% of sporadic cases are associated with cross-contaminated or undercooked or raw poultry. Crosscontamination occurs due to transfer of the microorganism to uncooked foods via contamination of surfaces or food workers’ hands. D. Clostridium botulinum The illness botulism was ﬁrst recognized around 900 AD. Emperor Leo VI of Byzantium forbade consumption of blood sausage because of its relationship to illness [13]. Before it was recognized as a microbial illness, botulism was termed ‘‘sausage poisoning’’ as the illness and deaths were ﬁrst associated with sausage. In fact, the term botulus is Latin for sausage. The microorganism associated with the illness was ﬁrst identiﬁed in 1897 by E. Van Ermingem and named Bacillus botulinus. The microorganism is a motile gram-positive rod that is a strict anaerobe. It is a sporeforming bacterium with oval to cylindrical, terminal to subterminal spores. There are four groups of C. botulinum (I, II, III, IV) based on physiological and phylogenetic relationships containing seven strains that produce antigenically different types of toxins (A through G) [14]. Groups I and II, types A, B, and E are most common in human disease. The habitat of the microorganism is soil or water. Type A is often found in western U.S. soils, while type B is more often found in the eastern United States. Type E is primarily of marine origin. The optimal temperature for growth of C. botulinum is 30–40°C. Temperature ranges depend upon type, with A, B, and F at 10–50°C and type E at 3.3–45°C. The spore heat resistance of C. botulinum is very high. Type A spores have a maximum identiﬁed D121°C of 0.21 min in phosphate buffer, pH 7. The heat resistance of type A C. botulinum spores in other heating media is shown in Table 4. Type B spores (proteolytic, group I) have a D110°C of 1.19–2.0 min in phosphate buffer, pH 7.0, while nonproteolytic (group II) strains have a D82.2°C of 1.49–73.61 min. Type E spores are the least resistant, with a D80°C of 0.78 min in oyster homogenate and a D82.2°C of 0.49–0.74 min in crab meat [4]. The pH minima for types A, B, and E are within 4.7–4.8. The water activity minima are 0.94 for types A and B and 0.97 for type E. The foodborne illness termed botulism is an intoxication. The onset time is 12–36 hr, and the symptoms are blurred or double vision, dysphagia (difﬁculty swallowing), © 2003 by Marcel Dekker, Inc.

Table 4 Heat Resistance of Clostridium botulinum Strain 62A (Type A) Spores at 110°C Product Asparagus, canned, pH 5.04 Asparagus, canned, pH 5.42 Corn, canned Macaroni creole, pH 7.0 Peas, puree Peas, canned, pH 5.24 Peas, canned, pH 6.0 Spanish rice, pH 7.0 Spinach, canned, pH 5.37 Spinach, canned, pH 5.39 Squash Tomato juice, pH 4.2 Tomato juice, pH 4.2 Phosphate buffer, M/15, pH 7.0

Distilled water

D value (min)

z value (°C)

1.22 0.61 1.89 2.48 1.98 0.61 1.22 2.37 0.61 1.74 2.01 1.50–1.59a 0.92–0.98 0.88 1.74 1.34 1.6–1.9 1.01 1.79

8.8 7.9 11.6 8.8 8.3 7.6 7.5 8.6 8.4 10.0 8.2 9.43 — 7.6 10.0 9.8 8.1–9.2 9.1 8.5

a Strain A16037 Source: Ref. 4.

general weakness, nausea, vomiting, dysphonia (confused speech), and dizziness. The intoxication is due to a neurotoxin which ﬁrst affects the neuromuscular junctions in the head and neck. The toxin causes paralysis which progresses to the chest and extremities. Death occurs when paralysis reaches the muscles of the diaphragm or heart. Duration of the illness can be from 1 day to several months. A high proportion of patients require respiratory therapy. Death occurs without treatment in 3–6 days. The mortality rate was very high (30–65%) in the early part of the 20th century but has been reduced signiﬁcantly in recent years due to better detection and treatment. The treatment for botulism is administration of an antitoxin. Its success depends upon timing since the toxin binds to myoneural junctions irreversibly. Clostridium botulinum toxins are proteins (150 kDa) produced by the cell as inactive protoxins. These are activated to the toxic form by trypsin or bacterial proteases [14]. Clostridium botulinum toxin is one of the most toxic substances known; C. botulinum type A produces 30,000,000 mouse LD50 /mg. The approximate human LD50 is 1 ng/kg. The toxin is absorbed into bloodstream through respiratory mucous membranes or walls of stomach or small intestine. It then enters the peripheral nervous system and attaches at the myoneural junction blocking release of acetylcholine and causing paralysis of the muscle. Heat resistance of the toxin is low, with 5 to 10 min at 80°C (type A) or 15 min at 90°C (type B) required to inactivate. Because of the seriousness of the illness, incidence statistics for the microorganism have been kept for over 100 years. From 1899–1973, there were 274 outbreaks of botulism, with the highest proportion of associated foods being vegetables, ﬁsh and ﬁsh products, and fruits. The same trend held in outbreaks from 1983–1992, with approximately © 2003 by Marcel Dekker, Inc.

50% associated with vegetables and 19% ﬁsh and ﬁsh products. From 1988 to 1997, there were 73 outbreaks involving 189 cases of C. botulinum food poisoning and 12 deaths (6.3%) [7,8]. Foodborne botulism outbreaks have traditionally been associated with low-acid canned vegetables and meats and vacuum-packaged ﬁsh and seafoods. Most outbreaks or cases associated with low-acid foods are home-preserved. This is most likely due to insufﬁcient heat processing during the home canning procedure. Recent outbreaks have been associated with unique products that are primarily home-preserved products. Consumption of home-canned jalapeno pepper hot sauce (type B toxin), baked potatoes, potato salad/ three bean salad, sauteed onions used to make patty melt sandwiches, garlic or roasted vegetables in oil, home-pickled eggs, and uneviscerated ﬁsh have all led to outbreaks. The outbreaks associated with potato salad and baked potato were due to baking the potatoes in aluminum foil followed by severe temperature abuse. The aluminum foil caused the atmosphere between the foil and potato to be anaerobic and allowed growth of the C. botulinum. Two of the most famous commercial outbreaks involved underprocessed commercially produced soup in 1971 which resulted in 1 death [15] and an outbreak of type E C. botulinum in 1963 associated with smoked vacuum-packaged whiteﬁsh in Tennessee, Kentucky, and Alabama that resulted in 17 cases and 5 deaths [13]. Infant botulism was ﬁrst recognized in 1976 in California. Infants less than 1 year old are susceptible to this illness. In adults, preformed C. botulinum toxin must be ingested. In infants, if as few as 10–100 spores of C. botulinum are ingested, they may germinate in the intestinal tract and produce toxin [14]. The illness occurs in infants most likely because their intestinal microﬂora are not established enough to prevent C. botulinum colonization. Types A and B are primarily involved. Symptoms of the illness are weakness, loss of head control, and diminished gag reﬂex. Food sources for the illness are characterized by no terminal heat process and include honey and corn syrup. E.

Clostridium perfringens

Clostridium perfringens (formerly C. welchii) is a gram-positive, nonmotile, anaerobic rod. Spores are present but difﬁcult to demonstrate. The optimal temperature for growth is 43–46°C (15–50°C range) [16]. Clostridium perfringens may be found in soil, water, dust, air, and certain raw foods such as meats and spices. Clostridium perfringens spores have a D90°C of 0.015–8.7 min in phosphate buffer, pH 7.0, and a D98.9°C of 31.4 min in beef gravy [4]. The microorganism is not known to survive commercial sterilization for low-acid canned foods. The pH range for growth of C. perfringens is 5–9, and the optimum is 6–7. The minimum aw for growth is 0.95–0.97. The microorganism has a sodium chloride maximum of 7–8% and is inhibited by 5% [16]. Clostridium perfringens is relatively sensitive to freezing. At ⫺15°C for 35 days, a greater than 99.9% kill occurs [17]. The gastroenteritis syndrome is an infection and is the result of an enterotoxin formed in the intestine. Onset time is 8–24 hr and primary symptoms include diarrhea and abdominal cramps. The duration is 12–24 hr and the mortality is low. The microorganism produces a protein enterotoxin (35 kDa) during sporulation, and concentration of the toxin is greatest immediately prior to cell lysis. Sporulation occurs at a high rate in the gut. The number of cells to cause an illness is around 6–8 log CFU. Clostridium perfringens accounts for approximately 10% of total food poisoning outbreaks in the United States. From 1988–1997, the microorganism was associated with 97 CDC-conﬁrmed outbreaks involving 6573 cases [7,8]. This number of cases was second © 2003 by Marcel Dekker, Inc.

only to Salmonella. Foods associated with C. perfringens are primarily meat based. Beef, turkey, and ethnic dishes with meat are all risks. A typical food poisoning outbreak scenario would involve a meat dish, especially one with gravy or sauce, that is inadequately heated to completely destroy spores. Inadequately cooling causes germination and outgrowth of the spores. Inadequate reheating (⬍75°C) allows survival of high numbers of C. perfringens. A major problem locale is food service steam tables. F.

Escherichia coli

Escherichia coli was ﬁrst described in 1885 by T. Escherich, who called it Bacterium coli commune. Escherichia coli is a gram-negative, nonsporeforming rod which is motile with peritrichous ﬂagella. It is a facultative anaerobe. The temperature growth range is 15 to 45°C and the optimum is 37°C. One source of the pathogenic strains of the microorganism is the gastrointestinal tract of warm-blooded animals. Tolerances are similar to generic E. coli, with an optimum pH of 6.5–7 (with the exception of E. coli O157:H7; see following discussion) and water activity minimum of 0.96. Escherichia coli is classiﬁed by serotyping based upon the O antigen (heat stable somatic; ⬎170 groups), K antigen (capsular; heat labile somatic; ⬎100 groups), and H antigen (ﬂagellar; 56 groups). There are at least ﬁve groups of pathogenic E. coli, including enteropathogenic (EPEC), enterotoxigenic (ETEC), enteroinvasive (EIEC), enterohemorrhagic (EHEC), and enteroaggregative (EaggC). Disease manifestations vary with pathogenic type. Enteropathogenic E. coli involves primarily sporadic cases, and outbreaks are usually associated with neonatal or infantile diarrhea. The pathogenesis of neonatal and infantile diarrhea involves colonization of the intestine, adherence, effacement, and invasion. This probably causes most diarrhea. Some strains produce toxins and cytotoxins. Enterotoxigenic E. coli causes traveler’s diarrhea. Onset time is 1–3 days and primary symptoms include abdominal cramps, diarrhea, headache, and moderate fever. The duration is 24–72 hr and mortality rate is very low. The microorganism attaches to epithelial cells and colonizes the epithelium. It produces heat-labile (LT) or heat-stable (ST) enterotoxins that cause diarrhea. The heat labile enterotoxin (60°C, 30 min) has two subunits (A and B) and is an adenyl cyclase that increases cAMP. The heat stable enterotoxin (100°C, 15 min) is a low molecular weight (2000 Da) peptide that is a guanylate cyclase. Foods associated with ETEC outbreaks have included Brie cheese, turkey, salad vegetables, and seafood (Table 5) [18]. Enteroinvasive E. coli produces no enterotoxins but causes bloody diarrhea, cramps, vomiting, fever, and chills. Onset time is 12–72 hours and the duration may be days to weeks. The disease is similar to dysentery. The microorganism adheres and invades epithelial tissue in the colon causing necrosis. One food involved in an outbreak was Brie cheese contaminated by water used to clean cheesemaking equipment (Table 5). Enterohemorrhagic E. coli includes various serotypes (O4:nonmotile, O11:NM, O26:H11, O45:H2, O111:nonmotile, O111:H8, O104:H21, O145:nonmotile, O157:H7). Primary symptoms of EHEC are diarrhea (often bloody) and abdominal cramps. The microorganism apparently originates in dairy cattle (healthy), deer, sheep, and water and is also transmitted person to person. Escherichia coli O157:H7 is unique among the E. coli in that it survives low pH very well. The optimal temperature for the microorganism is 30–42°C and it does not grow at 44.5°C. The minimal temperature for growth is 8–10°C. The heat resistance of the microorganism is D64.3°C of 9.6 sec. It survives freezing well. © 2003 by Marcel Dekker, Inc.

Table 5 Date

Selected Outbreaks of Escherichia coli Associated Foodborne Illnesses Location

Cases

Type

Food

1971

Several U.S. states

387

EIEC (O124:B17)

1982 1983 1984 1984 1990 1993

MI, OR DC, IL, WI, GA, CO NE ME ND WA, ID, NV, CA

47 169 34 (4 deaths) 42 70 (2 HUS) 582 (5 deaths)

EHEC ETEC (O27:H20) EHEC (O157:H7) ETEC EHEC EHEC

1993 1993 1994 1994 1995

NH RI WA, CA Scotland TN, GA

8 47 23 100 (1 death) 10

ETEC ETEC EHEC EHEC EHEC

Salad Salad Salami Pasteurized milk Ground beef

1996

Western U.S.

EHEC

Unpasteurized apple cider

1996 1996 1997 1997

Japan Scotland MI, VA CO

EHEC EHEC EHEC EHEC

Radish sprouts Cooked meat, gravy Alfalfa sprouts Ground beef

Source: Refs. 18, 27, 44–49.

© 2003 by Marcel Dekker, Inc.

⬎6,000 501 (21 deaths) ⬃80 15

Imported brie and camembert cheese Ground beef Brie cheese Ground beef Seafood Roast beef Ground beef

Notes Source: contaminated water Fast-food outlet Nursing home

Undercooked, served at fastfood outlet

Undercooking or cross-contamination Dropped apples; Deer contamination?

The illness caused by EHEC has an onset time of 12–60 hr. The duration of the illness may be 2–9 days with an average of 4 days. A sequelae that occurs in 2–7% of patients (most often younger age groups and the elderly) is development of hemolytic uremic syndrome (HUS), characterized by hemolytic anemia, thrombocytopenia, and renal failure. Damage to renal endothelial cells is caused by blood clotting in the capillaries of kidney and accumulation of waste products in blood, which results in a need for dialysis. The death rate associated with HUS is 3–5%. Thrombotic thrombocytopenic purpura is an involvement of the central nervous system that occurs primarily in elderly adults. This can lead to blood clots in the brain. The infectious dose of EHEC for susceptible persons is estimated to be as low as 2 to 2000 cells [19]. The site of attack is the colon with bloody diarrhea occurring due to attachment and effacement of cells. Enterohemorrhagic E. coli produces Shiga toxin I (Stx I), also known as verocytotoxin or verotoxin (70 kDa), and Shiga toxin II. The former is a protein with two subunits, A and B. Stx I A subunit (32 kDa) cleaves a speciﬁc adenine residue from 28S subunit of rRNA and inhibits protein synthesis. Stx I B subunit (5 per molecule, 7.7 kDa each) binds to galactose α-(1-4)galactose-β-(1-4)-glucose ceramide (Gb3) receptors [19]. Kidney endothelial cells and colon endothelial cells are both high in these receptors. Foods implicated have included ground beef, roast beef, raw milk, apple cider, meat sandwiches, mayonnaise, lettuce, dry salami, as well as person-to-person transmission and from domestic animals to persons. Enteroaggregative E. coli is a recognized agent of watery mucoid diarrhea, especially in children. It is associated with persistent diarrhea of ⬎14 days. The microorganism is thought to adhere to the intestinal mucosa and produce enterotoxins and cytotoxins [20]. There have been numerous outbreaks of all types of pathogenic E. coli (Table 5). Conﬁrmed outbreaks, cases, and deaths associated with unspeciﬁed types of pathogenic E. coli in 1973–1997 were 103, 4691, and 12, respectively [6–8]. The FoodNet surveillance system has shown that E. coli O157 occurs in the United States at a rate of 2.9 cases per 100,000 population (Table 3) [12]. G.

Listeria monocytogenes

That L. monocytogenes may infect humans and animals was recognized as early as the 1910s. However, the microorganism was only recognized as a food-transmitted pathogen in 1981, possibly owing to difﬁculty in isolation and identiﬁcation. Listeria monocytogenes are nonsporeforming, gram-positive rods that are facultatively anaerobic to microaerophilic (5–10% CO2). The microorganism is motile via peritrichous ﬂagella at 20–25°C, but not at 37°C [21]. It has an optimal growth temperature of 30–37°C and a 3–45°C range. Because it can grow relatively well at low temperatures, the microorganism is known as a psychrotroph. Listeria monocytogenes is truly ubiquitous in that it can be found in many places. It occurs in human carriers (1–10% of the population), healthy domestic animals, normal and mastitic milk, silage (especially improperly fermented, i.e., high pH), soil, and leafy vegetables. The microorganism is very tolerant to environmental stresses compared to other vegetative cells. Listeria monocytogenes has a high vegetative cell heat resistance (Table 6), but is not known to survive pasteurization of milk. It grows in ⬎10% salt and survives in saturated salt solutions. It has a pH range for growth of 5–9. Human listeriosis may be caused by any of 13 serotypes of L. monocytogenes, but the majority of cases are due to 1/2a, 1/2b and 4b [21]. Listeriosis causes an estimated 2500 serious illnesses and 500 deaths in the United States each year [22]. Listeria often may pass through the digestive systems of healthy © 2003 by Marcel Dekker, Inc.

Table 6

Heat Resistance of Listeria monocytogenes in Selected Products

Product Ground meat Ground meat, cured Fermented sausage Roast beef Beef Beef homogenate Naturally contaminated beef Weiner batter Chicken leg Chicken breast Chicken homogenate Carrot homogenate Raw milk, raw skim milk, raw whole milk, cream

D60°C value (min) 3.12 16.7 9.2–11 3.5–4.5 3.8 6.27–8.32 1.6 2.3 5.6 8.7 5.02–5.29 5.02–7.76 D52.2 ⫽ 24.08–52.8 D57.8 ⫽ 3.97–8.17 D63.3 ⫽ 0.22–0.58 D66.1 ⫽ 0.10–0.29

Source: Ref. 4.

people, causing only mild, ﬂulike symptoms or without causing any symptoms at all. The main target populations for listeriosis include pregnant women (or more precisely their fetuses), immunocompromised persons, persons with chronic illnesses, and elderly persons. Antacids or laxatives may predispose persons to listeriosis if given in large doses [21]. Most cases of listeriosis are sporadic. Foodborne illness caused by L. monocytogenes in pregnant women can result in miscarriage, fetal death, and severe illness or death of a newborn infant. Pregnant women are most frequently infected in the third trimester [21]. The mother’s symptoms are inﬂuenza-like (chills, fever, sore throat, headache, dizziness, low back pain, diarrhea). During the illness the microorganism localizes in the uterus in the amniotic ﬂuid resulting in abortion, stillbirth, or delivery of an acutely ill baby. Once the fetus is aborted, the mother becomes asymptomatic. In newborns infected with the microorganism, perinatal septicemia involving the central nervous system, circulatory system, or respiratory system or meningitis may occur. For other target groups, meningitis, meningoencephalitis, or bacteremia are the most common outcomes [23]. It is not known why the microorganism has an afﬁnity for the central nervous system. In target populations the onset time for listeriosis can be as short as 1 day or as long as 91 days. The illness has been successfully treated with parenteral penicillin or ampicillin. In food-related human infections, L. monocytogenes likely enters the host via intestinal epithelial cells or Peyer’s patches and are phagocytized and transported to the liver where they cause infection. Several surface proteins and enzymes, including internalin, listeriolysin O, and phosphatidylinositol phospholipase C, are virulence factors. The ﬁrst recognized outbreak of foodborne listeriosis occurred in Nova Scotia in 1981. The outbreak was associated with coleslaw and resulted in 41 cases with 17 deaths, primarily among infants. The cause of the outbreak was determined to be fertilizing cabbage with manure from sheep with listeriosis (circling disease). The cabbage was harvested © 2003 by Marcel Dekker, Inc.

and placed in cold storage (4°C) for a long period, thereby selecting for L. monocytogenes. In 1983, in Massachusetts, L. monocytogenes 4b in pasteurized milk was theorized to be the source of an outbreak producing 49 cases (42 adults) and 14 deaths. The reason for the outbreak was unknown as no defects were found in the pasteurization system, although Listeria were present in a dairy herd supplying the milk processor. The largest outbreak in the United States was in California in 1985 and implicated L. monocytogenes 4b in a Mexican-style cheese called queso blanco. There were 142 cases and 48 deaths in the outbreak. The cause was theorized to be due to use of raw milk in the cheese and/or general contamination of the processing plant and workers. In 1997, there were 45 cases of listeriosis due to contaminated chocolate milk [24]. In Switzerland, between 1983 and 1987, at least 122 cases and 34 deaths occurred due to consumption of Vacherin Mont d’Or cheese. In France, in 1992, 279 cases, 22 abortions, and 63 deaths occurred because of consumption of pork tongue in aspic contaminated with L. monocytogenes. Also in France, in 1995, 17 cases, two stillbirths, and two abortions were associated with L. monocytogenes contaminated Brie de Meaux soft cheese. In 1998–1999, at least 50 cases of listeriosis were caused by consumption of hot dogs and/or deli meats contaminated with L. monocytogenes 4b [25]. While there are few outbreaks of listeriosis, the illness occurs at a rate of 0.4 cases per 100,000 population in the United States according to CDC FoodNet (Table 3) [12]. Listeria monocytogenes accounted for the greatest number of food recalls in the United States during the period 1993–1998 [26]. That is due to a zero tolerance policy for the microorganism in many foods. Foods involved in the recalls have primarily included dairy products (e.g., ice cream bars, soft cheeses), meats (hot dogs, etc.), shellﬁsh, and salads. In 2001, the FDA and the U.S. Department of Agriculture’s Food Safety and Inspection Service released a draft risk assessment of the potential risks of listeriosis from eating certain ready-to-eat foods and an action plan designed to reduce the risk of foodborne illness caused by L. monocytogenes [22]. The agencies advised consumers to use perishable precooked or ready-to-eat items as quickly as possible, clean refrigerators regularly, and use a refrigerator thermometer to ensure that temperatures are 40°F to reduce risk of listeriosis. For pregnant women, the elderly, and immunocompromised individuals, they recommended avoidance of hot dogs or luncheon meats (unless heated until ‘‘steaming hot’’), soft cheeses (e.g., feta, Brie or Camembert, blue-veined cheeses, queso blanco fresco), refrigerated pate´ or meat spreads, refrigerated smoked seafood unless part of a cooked dish, and raw milk. H.

Salmonella

Nontyphoid or foodborne illness associated Salmonella was ﬁrst discovered in 1888 by A. A. H. Gaertner in Germany. The microorganism caused an outbreak with 50 cases due to consumption of raw ground beef (Salmonella serovar Enteritidis). Salmonella are gramnegative, nonsporeforming rods that are motile by peritrichous ﬂagella (except S. Pullorum and S. Gallinarum, which are chicken pathogens). They are facultatively anaerobic. The growth range for Salmonella is 5–47°C. Lowest growth temperatures observed were S. Heidelberg at 5.3°C and S. Typhimurium at 6.2°C [27]. The optimal temperature for growth of the microorganism is 37°C. Salmonella are classiﬁed based upon biochemical characteristics, antigenic characteristics, DNA homology, and electrophoretic patterns [28]. The latest classiﬁcation scheme recognizes two species: Salmonella bongori and Salmonella enterica. The latter © 2003 by Marcel Dekker, Inc.

has six subspecies: arizonae, diarizonae, houteane, indica, salamae, and enterica. Salmonella enterica ssp. enterica contains most of the serovars (1427) involved in foodborne illness, including Dublin, Enteritidis, Heidelberg, London, Montevideo, Pullorum, Tennessee, Typhi, and Typhimurium [29]. Salmonella occur in the intestinal tract of animals such as birds, reptiles, farm animals, humans, and insects, in water, and in soil. They may also be found in animal feeds and foods, including raw milk, poultry (up to 70%), raw meats, eggs, and raw seafood. The pathogen generally has a pH range of 3.6–9.5 and an optimum of 6.5–7.5. The minimum aw for growth is ca. 0.94. Salt concentrations of ⬎2% delay growth of the microorganism. Salmonella is very tolerant of freezing and drying. The most heat resistant serovar is S. Senftenberg with the following D values: D55°C ⫽ 24 min in microbiological medium, D60°C ⫽ 6.25 min in 0.5% NaCl and 10.64 min in green pea soup, D65.5°C ⫽ 0.66 min in beef bouillon and 1.11 min in skim milk, D71.1°C ⫽ 1.2 sec in milk, and D90°C ⫽ 30–42 min in milk chocolate [4]. Increased tolerance to various environmental stresses has been demonstrated for Salmonella strains exposed to acid [30]. The nontyphoid foodborne illness caused by Salmonella is a gastroenteritis called salmonellosis. It is classiﬁed as an infection. The onset time is 8–72 hr and duration is ca. 5 days. The primary symptoms include nausea, vomiting, abdominal pain, headache, chills, mild fever, and diarrhea. Salmonellosis may progress to septicemia or chronic sequelae such as ankylosing spondylitis, reactive arthritis, Reiter’s syndrome (see Sec. II.I) or rheumatoid arthritis [28]. The mortality rate associated with the illness is low (⬍1%) but is age dependent. The number of cells required to produce symptoms varies with individual and strain and can be as low as 1 CFU/g of food or up to 7 log. It was estimated that 6 cells per 65 g of ice cream caused a massive outbreak of salmonellosis in 1994 [31]. Populations at highest risk for Salmonella infections are infants, the elderly, and those with chronic illnesses. Salmonella cells attach to and invade gastrointestinal tissue in the small intestine. Invasion of the intestinal epithelial cells triggers leukocyte inﬂux and an inﬂammation. Salmonella also produce an endotoxin, enterotoxin, and cytotoxin. The enterotoxin activates host adenyl cyclase resulting in diarrhea. Some serovars require plasmids for virulence. Epidemiological estimates suggest that there are 2 to 3 million cases of salmonellosis annually in the United States [11]. Historically, salmonellosis has been associated with the greatest number of conﬁrmed foodborne illnesses, with 790 outbreaks and 55,864 cases from 1973 to 1987 [7]; 549 outbreaks, 21,177 cases, and 38 deaths from 1988– 1992 [6]; and 357 outbreaks, 32,610 cases, and 13 deaths from 1993–1997 [8]. The CDC’s FoodNet has shown that salmonellosis is the second most prevalent foodborne illness (12– 14.5 cases per 100,000 population) behind campylobacteriosis (Table 3) [12]. Salmonella Typhimurium and S. Enteritidis are the two serovars responsible for the greatest number of cases. Foods historically involved in salmonellosis outbreaks include eggs and egg products, poultry, meats, ice cream, and potato salad. The microorganism has recently been involved in a number of outbreaks involving fruits and vegetables such as tomatoes, melons, and sprouts. The highest percentage of outbreaks occur in May, June, July, and August. The largest outbreak of salmonellosis in U.S. history was in 1985 in the Chicago area. The implicated food was pasteurized milk and the serovar isolated was Typhimurium. There were an estimated 150,000 cases, ⬎16,000 culture-conﬁrmed cases, 2777 hospitalizations, and seven deaths. The suspected cause for the outbreak was a leaking valve © 2003 by Marcel Dekker, Inc.

connecting the raw and pasteurized milk systems in a large milk processing operation. Several outbreaks of salmonellosis have been associated with melon products, e.g. (year, number of cases, causative agent, food): 1989, 295 cases, S. Chester, cantaloupe; 1991, 143 cases, S. Poona, cantaloupe; 1991, 39 cases, S. Javiana, watermelon. In each of these cases it was suggested that the microorganism contaminated the outside of the melon and the interior melon surface was inoculated when sliced. In some cases, these melons were placed on salad bars in restaurants which had little or no temperature control. This allowed the Salmonella to increase to infective levels over the course of the storage. In 1995, there were 63 cases of salmonellosis in Florida caused by consumption of unpasteurized orange juice contaminated with S. Hartford. A similar outbreak involving S. Muenchen in unpasteurized orange juice with over 200 cases occurred in Washington, Oregon, several other U.S. states, and Canada in 1999 [32]. In 1994, another large outbreak with ca. 2000 documented cases (estimated ca. 224,000 cases nationwide) occurred involving S. Enteritidis in commercially processed ice cream. The milk that was used to make the ice cream was contaminated by raw eggs during transport in a tank truck [33]. Salmonella Enteritidis may contaminate raw eggs in the ovaries of the hen. This is known as transovarian transmission. Approximately 1 in 20,000 eggs is infected and the level of S. Enteritidis per egg is ca. 10–20 cells. I.

Shigella

Shigella are gram-negative, nonsporeforming rods that are weakly motile and lactose negative [34]. They are facultative anaerobes with a growth range of 6–48°C and an optimum of 37°C. Four species of Shigella are grouped biochemically and on O antigens: S. dysenteriae (serogroup A), S. ﬂexneri (serogroup B), S. boydii (serogroup C), and S. sonnei (serogroup D). Shigella shares many similarities with EIEC. The microorganisms are primarily of human origin and are spread to food by carriers and contaminated water. The pH minimum for Shigella is 4.9 and its maximum is 9.3. The aw minimum for growth is approximately 0.94 and the maximum salt concentration is ca. 4–5%. The microorganism is not particularly heat resistant. Shigella gastroenteritis, called shigellosis, or bacillary dysentery, is an infection with an onset time of 1–4 days and a duration of 5–6 days. Primary symptoms are variable but worst cases involve bloody diarrhea, mucus secretion, dehydration, fever, and chills. The mortality rate is generally very low, but in susceptible populations (young, elderly, immunocompromised) death may occur. Shigella dysenteriae causes the most and S. sonnei the least severe symptoms. Shigella ﬂexneri and S. boydii are intermediate in severity. The number of cells to cause the illness is estimated at 10–100. A sequelae associated with shigellosis is Reiter’s syndrome, also called reactive arthritis. Symptoms are swelling of joints, conjunctivitis, and urethritis. It follows foodborne infection such as shigellosis, salmonellosis, campylobacteriosis, or yersiniosis. Reiter’s patients have predisposition to syndrome due to presence of histocompatibility antigen (HLA B27) [35]. In the sequelae, bacteria attack the host cell causing production of antigen which reacts with HLA B27. The site of Shigella attack is the colon. Cells attach to the epithelium, invade, and multiply in the cells causing damage to the mucosal layer by inﬂammation and necrosis. Shigella ﬂexneri produces an enterotoxin (ShET1), while 80% of other Shigella produce another enterotoxin (ShET2) [34]. Shiga toxin is an enterotoxin produced by S. dysenteriae Type I. The estimate of annual cases of foodborne and waterborne shigellosis in the United States is 90,000–150,000 [11]. Strains involved in U.S. cases are primarily S. sonnei (65%) © 2003 by Marcel Dekker, Inc.

and S. ﬂexneri (31%). Outbreaks, cases, and deaths associated with Shigella in the United States have been as follows for the periods speciﬁed: 1961–1975, 72 outbreaks, 10,648 cases; 1973–1987, 104 outbreaks, 4488 cases, two deaths; 1988–1992, 25 outbreaks, 4788 cases, no deaths; and 1993–1997, 43 outbreaks, 1555 cases, no deaths [6–8,36]. According to FoodNet, in 2000 there were 11.6 cases of Shigella foodborne illness per 100,000 population in the United States (Table 3) [12]. Foods most associated with shigellosis are those with a high degree of handling or ones which could be contaminated by waterborne Shigella. The most implicated foods are salads (potato, shrimp/tuna, chicken) and seafood/shellﬁsh. Many outbreaks have occurred in food service establishments such as hospital cafeterias and restaurants. J. Staphylococcus aureus Staphylococcus aureus was ﬁrst shown to be associated with food in 1914 when M. A. Barber implicated the microorganism in an illness associated with milk from a cow with staphylococcal mastitis [37]. The microorganism presents as gram-positive cocci that grow in clusters and is facultatively anaerobic. The growth range for S. aureus is 7–48°C, and it has an optimal temperature of 37°C. A primary source for S. aureus in foods is humans. The microorganism is carried in the nasal cavity, on the skin (arms, hands, face), and by wounds (boils, carbuncles). Staphylococcus aureus may also be found in air and dust and on clothing. It may be associated with mastitis infection in dairy cattle. The pH range for S. aureus is 4.0–9.8 and its optimum is 6–7. It is uniquely tolerant to low water activities with growth at a minimum of 0.86 and in the presence of ca. 20% salt [37]. Staphylococcus aureus gastroenteritis is an intoxication. It has a very short onset time of around 4 hr (range 1–6 hr). Primary symptoms include nausea, vomiting, and severe abdominal cramps (secondary symptoms: diarrhea, sweating, headache, prostration, temperature drop). The duration is 24–48 hr and the mortality rate is very low. Foods associated with S. aureus gastroenteritis are generally made by hand and improperly refrigerated. The estimated cases per year are 1.1 to 1.5 million [11]. Documented numbers of cases are low owing to sporadic cases not being reported. From 1988– 1997, there were 92 CDC-conﬁrmed outbreaks of S. aureus gastroenteritis involving 3091 cases and one death [7,8]. Foods involved in S. aureus outbreaks are shown in Table 7.

Table 7 Outbreaks of Staphylococcus aureus Foodborne Illness Associated with Various Food Products Food Product

1961–1973

1975–1981

1983–1992

Ham Turkey Chicken Beef and pork Dairy products Baked goods Eggs Salads Others Total

137 52 50 60 14 55 17 31 108 578

57 14 10 0 4 14 0 34 27 194

16 4 1 11 1 7 1 10 25 76

Source: Refs. 6, 7.

© 2003 by Marcel Dekker, Inc.

Toxins produced by S. aureus are proteins of 26–30 kDa and are very resistant to proteolytic enzymes (trypsin, chymotrypsin) and heat. Coagulase production and heatstable thermonuclease production by the microorganism are highly associated with toxin production. There are ten serologically different forms of the toxin: staphylococcal enterotoxin A (SEA), SEB, SEC1, SEC2, SEC3, SED, SEE, SEF, SEG, and SEH. The ﬁrst named is involved in more cases of foodborne illness than any of the other enterotoxins. The toxins are extremely heat resistant. Over 27 min at 121°C are required to inactivate 5 µg/ mL SEA in beef bouillon and ⬎7 min at 121°C are required to inactivate an unspeciﬁed amount in whole milk [4]. Relative thermal resistance of the enterotoxins is as follows: SEA ⬎ SEB ⬎ SEC. In contrast to toxin heat resistance, the vegetative cells have a D65.5 of 2.0–15.08 min, depending upon suspending medium. Production of toxin is favored by optimal growth conditions and the minimum water activity for production is 0.90 (SEA). Production of SEA is less sensitive to pH than SEB. The temperature range for production is 10–46°C and the optimum is 40°C. Minimal time is 4–6 hr and sufﬁcient production occurs during late log or stationary phases. The number of cells necessary to produce enough toxin for symptoms (1 µg) is 1,000,000–10,000,000. The maximal amount of toxin produced is 5–6 µg/mL. Toxin assay procedures are biological methods (feeding to cats, rhesus monkeys, chimps), reversed passive latex agglutination (sensitivity of 1 ng/mL), and ELISA. K.

Vibrio

Several species of Vibrio are known foodborne pathogens, including V. parahaemolyticus, V. cholerae, and V. vulniﬁcus. This bacterium is a gram-negative, nonsporeforming, straight to curved rod. Vibrio parahaemolyticus is motile by polar ﬂagella, while V. cholerae and V. vulniﬁcus may be nonmotile. All are facultative anaerobes. The growth range for V. parahaemolyticus is 13–45°C and its optimum is 22–43°C. For V. cholerae the temperature range is 10–43°C and the optimum is 37°C. The primary habitat for Vibrio is seawater. Vibrio parahaemolyticus has a pH range of 4.8–11 and an optimum of 7.8–8.6, while the range and optimum for V. cholerae is 5–9.6 and 7.6 and for V. vulniﬁcus is 5– 10 and 7.8. The water activity minima for each species are as follows: V. cholerae, 0.97; V. parahaemolyticus, 0.94; and V. vulniﬁcus, 0.96. Each species requires some amount of NaCl. The optimum for each species is 0.5, 3, and 2.5%, respectively. The heat resistance for each species depends upon heating medium. Vibrio cholerae has a D54°C of 1.04 min, 5.02 min, and 0.35 min in 1% peptone, crab meat homogenate, and oyster homogenate, respectively [4]. Vibrio parahaemolyticus has a D55°C of 0.02–0.29 min and 2.5 min in clam homogenate and crab homogenate, respectively. The heat sensitivity of V. vulniﬁcus is similar to V. parahaemolyticus [4]. Vibrio parahaemolyticus gastroenteritis was ﬁrst recognized in 1950. The onset time is 8–72 hr with a median of 18 hr [38]. The primary symptoms include diarrhea and abdominal cramps along with nausea, vomiting, and mild fever. The duration is 48–72 hr and the mortality rate is low. The number of cells required to initiate disease is around 5.0 to 7.0 log cells. More than 95% of stool isolates causing V. parahaemolyticus gastroenteritis produce a hemolysin to sheep or human red blood cells. Strains that produce the hemolysin are termed kanagawa positive. Vibrio cholerae has over 150 serogroups but only O1 and O139 have been linked © 2003 by Marcel Dekker, Inc.

to epidemic cholera. The O1 serogroup has three serotypes and two biotypes. The serotypes are known as Ogawa, Inaba, Hikojima. The O1 biotypes are classical and El Tor. Classical has a negative Voges–Proskauer reaction, while El Tor’s is positive. In addition, classical is nonhemolytic, while El Tor produces β-hemolysis on sheep blood [38]. Vibrio cholerae O139 Bengal was ﬁrst discovered in 1992 in India and Bangladesh and has a biotype similar to O1 El Tor. Onset time for V. cholerae is 6 hr to 5 days. The primary symptom is watery diarrhea (up to 1 L/hr), also called ‘‘rice water stools.’’ This condition brings about severe dehydration, salt imbalance, and hypertension. Treatment is ﬂuid and electrolyte replacement. Antibiotic treatment may reduce volume and duration of diarrhea. The infectious dose is 6 log depending upon the buffering capacity of the contaminated food. The microorganism produces cholera enterotoxin (CT), a protein of 85 kDa which has A and B subunits. The B subunits bind the cell membrane of the intestinal cells, and the A subunit stimulates adenyl cyclase in the cells. This leads to increased cAMP in the cell, increased chloride secretion, decreased NaCl absorption by the villus cells, and electrolyte movement into the lumen of the intestine. The osmotic gradient produced results in water ﬂow into the lumen and resultant diarrhea. Vibrio cholerae also has pathogenic non-O1/O139 biotypes. These are nonepidemic and are associated with gastroenteritis, soft tissue infections, and septicemia. The gastroenteritis syndrome has been highly associated with consumption of contaminated raw oysters. The symptoms are diarrhea, abdominal pain, and nausea. Human illness caused by V. vulniﬁcus has been associated primarily with consumption of raw oysters. It may cause a soft tissue infection or septicemia, especially in immunocompromised individuals. Individuals at risk for septicemia include persons with liver or blood-related disorders such as alcoholic cirrhosis or hemochromatosis [38]. Other predisposing conditions include use of immunosuppressive drugs and illnesses such as diabetes, renal disease, and gastric diseases. The onset time is 7 hr to several days [38]. If untreated, death can occur in 3–5 days and the mortality rate for the septicemia is 50%. From 1973 to 1987, there were 31 conﬁrmed outbreaks involving Vibrio (eight V. cholerae, 23 V. parahaemolyticus) with 1462 cases and 12 deaths [6]. All deaths involved V. cholerae. From 1988 to 1997, there were 15 outbreaks (ﬁve V. cholerae, nine V. parahaemolyticus, one V. vulniﬁcus), 99 cases and two deaths (one V. cholerae, one V. vulniﬁcus) [7]. Vibrio parahaemolyticus is the leading cause of food poisoning in Japan. Foods involved with conﬁrmed outbreaks have been primarily ﬁsh and shellﬁsh. Foods associated with V. cholerae outbreaks have involved shrimp, raw oysters, crab, ﬁsh, and mussels. L.

Yersinia enterocolitica

Yersinia enterocolitica was ﬁrst described in 1939 in New York and was named Bacterium enterocoliticum. It is a gram-negative, nonsporeforming rod that is facultatively anaerobic. Like L. monocytogenes, Y. enterocolitica is psychrotrophic with a growth range of ⫺2 to 45°C. Its optimal temperature range is 28–29°C. The microorganism may be found naturally among swine, birds, cats, dogs, wild animals, raw milk, soil, and water. Pigs are thought to be the primary source for serotypes pathogenic for humans. The bacterium has a pH range of 4.2–9.6 and it tolerates high pH well. The bacterium has a D62.8°C of 0.01– 0.96 min in milk with a z value of 5.11–5.78°C [4]. The gastroenteritis caused by the microorganism is called yersiniosis. It has an onset time of 3–7 days and a duration of 5–14 days. The symptoms include watery diarrhea, © 2003 by Marcel Dekker, Inc.

vomiting, fever, and severe abdominal cramps. The illness mimics appendicitis and victims may have appendectomies performed. The illness is rarely fatal. Reactive arthritis may follow the primary illness. Clinical symptoms vary with age of the patient. Pathogenic serotypes of Y. enterocolitica vary geographically. Serotype O8 is predominant in North America and is one of the more virulent strains. Its primary reservoir is swine. Serotypes O3, O9, O5, and 27 are found in Japan, Europe, and Canada. A number of avirulent strains exist. From 1973 to 1987 there were ﬁve CDC-documented outbreaks of yersiniosis involving 767 cases and no deaths [6]. The FoodNet surveillance system listed 0.5 cases of yersiniosis per 100,000 U.S. population in 2000, which was approximately 50% of the previous four years (Table 3) [12]. In a 1976 outbreak in New York, 222 children were made ill through consumption of chocolate milk. Eighteen unnecessary appendectomies were performed on the children. Serotype O8 was implicated. In the outbreak, contaminated chocolate syrup was added to pasteurized milk. Eighty-seven cases of yersiniosis occurred in 1982 in Washington state due to consumption of contaminated tofu. Serotype O8 was implicated and the source of the microorganism was contaminated water used in processing. In 1982, pasteurized milk was theorized to be the source of an outbreak in Tennessee, Arkansas, and Mississippi. Serotype O13a,b was responsible for 172 cases and 17 appendectomies. It was suggested that pasteurized milk in plastic jugs had become contaminated by plastic crates which had been stored on a hog farm and then were used in a milk processing facility without washing. III. MYCOTOXINS Toxins may be produced by molds as secondary metabolites. They are formed when large pools of primary metabolic precursors (e.g., amino acids, acetate, pyruvate, etc.) accumulate and are synthesized to remove primary precursors. Synthesis is initialized at the onset of stationary phase and occurs with lipid synthesis. Aﬂatoxins were the ﬁrst mycotoxins discovered. In 1960, 100,000 turkey poults died in England after eating peanut meal imported from Africa and South America. This was called Turkey X disease. It was later determined that a toxin produced by Aspergillus species was responsible for the turkey deaths. This toxin was named aﬂatoxin, from Aspergillus ﬂavus toxin. The toxin is actually produced by A. ﬂavus, A. parasiticus, and A. nomius. The environmental conditions that inﬂuence production most appear to be temperature and water activity. The optimal temperature for production is 24–28°C and the optimal aw is 0.93–0.98. There are several types of aﬂatoxins, including B1, B2, G1, G2, M1, and M2. The mycotoxins are ﬂuorescent under ultraviolet light and ﬂuoresce blue (hence, B1 and B2), green (G1 and G2) and blue, blue-violet (M1 and M2). The latter are produced in milk, which is why they are designated by M. Toxicity of the aﬂatoxins is, in decreasing order, B1 ⬎ M1 ⬎ G1 ⬎ B2 ⬎ G2, M2. Aﬂatoxins are hepatotoxic to birds, certain mammals, and ﬁsh (trout) and are also carcinogenic to rats and trout. Aﬂatoxin B1 is acutely toxic to humans and may be involved in liver cancer. The toxin is metabolized by animals to the toxic dihydroxyaﬂatoxin and carcinogenic aﬂatoxin epoxide [39]. Foods in which aﬂatoxin may be produced include peanuts, peanut butter, other nuts, fresh beef, ham, bacon, milk, cheese (through contaminated feed to dairy cattle), beer, cocoa, raisins, soybean meal, corn, rice, wheat, and cottonseed. Many other mold genera produce mycotoxins in various foodstuffs (Table 8). © 2003 by Marcel Dekker, Inc.

Table 8 Selected Mycotoxins, Mycotoxigenic Molds, Foods Associated with the Mycotoxin, and Animals Affected and Illnesses Toxin

Mold

Food

Fumonisins

Fusarium moniliforme

Corn

Ochratoxin A

Aspergillus sp. (A. ochraceus), Penicillium sp. (P. viridicatum, P. cyclopium, P. verrucosum) Penicillium sp. (P. patulum, P. claviforme, P. expansum), Aspergillus sp. (A. clavatus, A. terreus), Byssochlamys sp. (B. fulva, B. nivea) Aspergillus versicolor, A. nidulans, A. rugulosus Fusarium graminearum, F. culmorum

Grains, beans, peanuts, citrus fruits, nuts, country-cured ham

Patulin

Sterigmatocystin

Zearalenone

Animal/illness Equine leucoencephalomalacia; porcine pulmonary edema syndrome; lung edema in pigs and horses; poultry toxicity (immunosuppression), human esophageal cancer suspected Pigs; humans (renal disease); nephrotoxic, hepatotoxic, teratogenic, carcinogenic

Apples, apple products, bread, sausage, other fruits, moldy feeds

Poultry; mammals (cattle); ﬁsh; toxic, mutagenic, carcinogenic, teratogenic

Cheese, wheat, oats, coffee beans

Hepatotoxic, carcinogenic

Corn, wheat, oats, barley, sesame

Reproductive and infertility problems in poultry, swine, dairy cattle, sheep

Source: Refs. 39, 50.

IV. VIRUSES Diseases caused by foodborne viruses may be grouped as viral gastroenteritis or viral hepatitis. The majority of viral gastroenteritis outbreaks are caused by small round structured viruses (SRSV), of which Norwalk/Norwalk-like virus, Snow Mountain, Montgomery County, and Hawaii are members. To a lesser extent, astroviruses or caliciviruses may be involved. Other enteric viruses, such as adenovirus and groups A and B rotaviruses have not been fully demonstrated to be foodborne [40]. Viral hepatitis caused by hepatitis A virus may also be carried by foods. Illness caused by a Norwalk/Norwalk-like virus has an onset time of 1–2 days and a duration of 1–6 days. Symptoms include severe nausea and vomiting. Secondary symptoms may be diarrhea, abdominal pain, headache, and low grade fever. Stools do not contain blood, mucus, or white cells. The infectious dose is 10–100 virus particles [40]. Norwalk/Norwalk-like viruses are unaffected by low pH (ca. 3) and heat at 60°C for 30 © 2003 by Marcel Dekker, Inc.

min [4]. They are completely inactivated by free residual chlorine at 10 mg/L [4,40]. At 3.75 mg/L chlorine, the virus was only partially inactivated. Calicivirus infection is characterized by diarrhea and vomiting following a 1–3 day incubation period. Respiratory symptoms sometimes are evident. Infants and young children are most commonly infected. Duration is ca. 4 days. Astrovirus infection has an onset of 3–4 days. Primary symptoms include fever, diarrhea, headache, nausea, and malaise. Neither calicivirus nor astrovirus is inactivated by low pH, but both are inactivated by 10 mg/L free residual chlorine [40]. Hepatitis A (infectious hepatitis) is characterized by a sudden onset of fever, nausea, anorexia, and abdominal discomfort and is followed by jaundice. The onset is 1–7 weeks with an average of 30 days. The illness is transmissible until 1 week after the appearance of jaundice. The duration is 1–2 weeks up to months. All populations are susceptible but the illness is more common in adults. Hepatitis is spread by infected food handlers or fecal contamination of foods or food contact surfaces (fecal–oral route). Foods involved in hepatitis A outbreaks include those that require signiﬁcant handling, often in food service situations, and those contaminated by polluted water. In 1997, an outbreak of hepatitis A in Michigan was linked to consumption of strawberries imported from Mexico [41]. The strawberries were thought to have been contaminated in the ﬁeld. Other foods involved in outbreaks are shellﬁsh, salads, and deli foods. Hepatitis A virus is not inactivated by low pH (ca. 3). At 60°C in buffer, the virus was reduced by 0.3 log (infective units) after 10 min, while at 80°C the reduction was 4.3 log [4]. It is inactivated by 70% ethanol and 10 mg/L free residual chlorine [40]. The virus showed a 90% decrease in viability in mineral water at 4°C and room temperature after 519 days and 89 days, respectively [4]. V.

PROTOZOA

Cryptosporidium parvum causes an illness known as cryptosporidiosis, which is transmitted via fecal contamination of water or food. Onset time is 1–2 weeks and the duration is 2 days to 4 weeks. The microorganism forms oocysts that are resistant to chlorine and persist for long periods in the environment. Oocysts are susceptible to freezing, dehydration, high temperatures, and certain chemical sanitizers such as hydrogen peroxide, ozone, and chlorine dioxide [42]. They may be removed from municipal drinking water supplies by ﬁltration. Symptoms include severe watery diarrhea, abdominal pain, and anorexia. Surveillance for cases of cryptosporidiosis began in 1997 via the FoodNet surveillance system of the CDC [12]. The incidence rate in 2000 for the illness was 2.4 cases per 100,000 population, which was down from a high of 3.7 cases in 1997 (Table 3). Cyclosporiasis is caused by Cyclospora cayetanensis, a coccidian parasite that occurs in tropical waters. The illness is characterized by watery diarrhea, abdominal cramps, anorexia, weight loss, nausea, and vomiting. It has an onset of 1–11 days and lasts for up to several weeks. The microorganism is carried by contaminated water and foodborne outbreaks have been associated with raspberries, basil, and lettuce. According to CDC’s FoodNet, cyclosporiasis occurs at a rate of 0.1 cases per 100,000 U.S. population and has remained constant for three years (Table 3) [12]. Giardia lamblia, the causative agent of giardiasis, is one of the most common protozoal infections of humans worldwide [42]. Several animal hosts may serve as reservoirs for human infections. Human illnesses result from consumption of Giardia cysts through poor hygiene (fecal–oral route), drinking contaminated water, or from infected food handlers contaminating foods. High risk groups are infants, young children, and immunosup© 2003 by Marcel Dekker, Inc.

pressed individuals. Symptoms include diarrhea, cramps, and bloating. The onset is 5 to 24 days and the illness may last from several weeks to years. Toxoplasma gondii is a protozoa that is the causative agent of toxoplasmosis. The primary host for the microorganism is the cat. Humans may become infected by consuming infected meat or water or contacting cat feces. Meat from lambs, poultry, and wild game animals may serve as a source for the microorganism. In humans, the illness resembles mononucleosis. Most infected newborns do not exhibit clinical symptoms, but mental retardation may occur later in life [42]. Toxoplasmosis is sometimes seen in AIDS patients. Temperatures of 61°C or higher for 3.6 min or freezing at ⫺13°C will inactivate oocysts and cysts in meat [42].

VI. NEMATODES (ROUNDWORMS) Trichinella spiralis is the organism that causes trichinosis. The illness is transmitted to humans by consumption of infected meats of carnivores, including pork and wild game such as bear and cougar. Dogs may also be infected. The majority of individuals infected by Trichinella are asymptomatic [43]. Symptomatic illness begins with gastroenteritis symptoms including nausea, vomiting, diarrhea, and fever. Onset is 72 hr and the infection may last 2 weeks. Following initial symptoms, edema, muscle weakness, and pain occur as the larvae migrate and encyst in the muscles. Respiratory and neurological manifestations may also occur. Without treatment, trichinosis may cause death. Prevention is achieved by preventing contamination of meat or destroying the trichinae (encysted larvae) in meat by cooking to 71°C, freezing meat less than 15 cm thick for 6 (⫺29°C) to 20 (⫺15°C) days, or applying irradiation [42].

REFERENCES 1. S Doores. Food safety: current status and future needs. American Academy of Microbiology, Washington, DC, 1999. 2. S Palumbo, GN Stelma, C Abeyta. The Aeromonas hydrophila group. In: BM Lund, TC BairdParker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp 1011–1028. 3. PE Granum, TC Baird-Parker. 2000. Bacillus species. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp 1029–1039. 4. ICMSF. Microorganisms in Foods 5: Microbiological Speciﬁcations of Food Pathogens. London: Blackie Academic, 1996. 5. H Mahler, A Pasi, JM Kramer, P Schulte, AC Scoging, W Bar, S Krahenbuhl. Fulminant liver failure in association with the emetic toxin of Bacillus cereus. N Engl J Med 336:1142–1148, 1997. 6. NH Bean, PM Grifﬁn. Foodborne disease outbreaks in the United States, 1973–1987: pathogens, vehicles and trends. J Food Prot 53:804–817, 1990. 7. NH Bean, JS Goulding, C Lao, FJ Angulo. Surveillance for foodborne disease outbreaks— United States, 1988–1992. Morb Mort Weekly Rep 45(SS5):1–55, 1996. 8. SJ Olsen, LC MacKinon, JS Goulding, NH Bean, L Slutsker. Surveillance for foodborne disease outbreaks—United States, 1993–1997. Morb Mort Weekly Rep 49(SS01):1–51, 2000. 9. NJ Stern, JE Line. Campylobacter. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp. 1040–1056.

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10. BM Allos, MJ Blaser. Potential role of lipopolysaccharides of Campylobacter jejuni in the development of Guillain–Barre´ syndrome. J Endotoxin Res 62:53–57, 1995. 11. CAST. Foodborne pathogens, risks and consequences. Task Force Rep. 122. Ames, IA: Council for Agricultural Science and Technology, 1994. 12. CDC. Preliminary FoodNet data on the incidence of foodborne illness—selected sites, United States, 2000. Morb Mort Weekly Rep 50:241–246, 2001. 13. GM Dack. Characteristics of botulism outbreaks in the United States. In: KH Lewis, K Cassel Jr, eds. Botulism. Cincinnati, OH: U.S. Dept. Health Education and Welfare, Public Health Service, 1964, pp 33–40. 14. BM Lund, MW Peck. Clostridium botulinum. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp. 1057–1109. 15. The deadliest poison. Nutr Today 10(5):4–9, 1975. 16. RG Labbe. Clostridium perfringens. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp. 1110–1135. 17. CB Hoskins, PM Davidson. Recovery of Clostridium perfringens from food samples using an oxygen-reducing membrane fraction. J Food Prot 51:187–191, 1988. 18. GA Willshaw, T Cheasty, HR Smith. Escherichia coli. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp. 1136–1177. 19. RL Buchanan, MP Doyle. Foodborne disease signiﬁcance of Escherichia coli O157:H7 and other enterohemorrhagic E. coli. Food Technol 51(10):69–76, 1997. 20. T Vande Venter. Emerging foodborne diseases: a global responsibility. Food Nutr Agric 26: 4–13. 21. JM Farber, PI Peterkin. Listeria monocytogenes. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp 1178–1231. 22. CFSAN, FSIS. Interpretive Summary: Draft Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods. Washington, DC: Center for Food Safety and Applied Nutrition, Department of Health and Human Services and Food Safety Inspection Service, U.S. Department of Agriculture, 2001. 23. J Rocourt, P Cossart. Listeria monocytogenes. In: MP Doyle, LR Beuchat, TJ Montville, eds. Food Microbiology: Fundamentals and Frontiers. Washington, DC: ASM Press, 1997, pp 337– 352. 24. CB Dalton, CC Austin, J Sobel, PS Hayes, WF Bibb, LM Graves, B Swaminathan, ME Proctor, PM Grifﬁn. An outbreak of gastroenteritis and fever due to Listeria monocytogenes in milk. N Engl J Med 336:100–105, 1997. 25. CDC. Update: multistate outbreak of listeriosis—United States, 1998–1999. Morb Mort Weekly Rep 47:1117–1118, 1999. 26. S Wong, D Street, SI Delgado, KC Klontz. Recalls of foods and cosmetics due to microbial contamination reported to the U.S. Food and Drug Administration. J Food Prot 63:1113–1116, 2000. 27. JM Jay. Modern Food Microbiology, 6th Ed. Gaithersburg, MD: Aspen, 2000. 28. J-Y D’Aoust. Salmonella. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp 1233–1299. 29. J-Y D’Aoust. Salmonella species. In MP Doyle, LR Beuchat, TJ Montville, eds. Food Microbiology: Fundamentals and Frontiers. Washington, DC: ASM Press, 1997, pp 129–158. 30. GJ Leyer, EA Johnson. Acid adaptation induces cross-protection against environmental stresses in Salmonella typhimurium. Appl Environ Microbiol 59:1842–1847, 1993. 31. KJ Vought, SR Tatini. Salmonella enteritidis contamination of ice cream associated with a 1994 multistate outbreak. J Food Prot 61:5–10, 1998. 32. CDC. Outbreak of Salmonella serotype Muenchen infections associated with unpasteurized

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orange juice—United States and Canada, June 1999. Morb Mort Weekly Rep 48:582–585, 1999. TW Hennessy, CW Hedberg, L Slutsker, KE White, JM Besser-Wiek, ME Moen, J Feldman, WW Coleman, LM Edmonson, KL MacDonald, MT Osterholm. A national outbreak of Salmonella enteritidis infections from ice cream. N Engl J Med 334:1281–1286, 1996. KA Lampel, JM Madden, IK Wachsmuth. Shigella species. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp 1300–1316. JL Smith, PM Fratamico. Long-term consequences of foodborne disease. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp 1545–1562. K Wachsmuth, GK Morris. Shigella. In: MP Doyle, ed. Foodborne Bacterial Pathogens. New York: Marcel Dekker, 1990, pp. 447–462. TC Baird-Parker. Staphylococcus aureus. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp. 1317– 1335. CA Kaysner. Vibrio species. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp 1336–1362. MO Moss. Toxigenic fungi and mycotoxins. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp 1490– 1517. EO Caul. Foodborne viruses. In: BM Lund, TC Baird-Parker, GW Gould, eds. The Microbiological Safety and Quality of Food. Gaithersburg, MD: Aspen, 2000, pp 1457–1489. CDC. Hepatitis A associated with consumption of frozen strawberries—Michigan. Morb Mort Weekly Rep 46:288,295, 1997. CA Speer. Protozoan parasites acquired from food and water. In: MP Doyle, LR Beuchat, TJ Montville, eds. Food Microbiology: Fundamentals and Frontiers. Washington, DC: ASM Press, 1997, pp 478–493. CW Kim. Helminths in meat. In: MP Doyle, LR Beuchat, TJ Montville, eds. Food Microbiology: Fundamentals and Frontiers. Washington, DC: ASM Press, 1997, pp 449–462. CDC. Update: multistate outbreak of Escherichia coli O157:H7 infections from hamburgers— western United States, 1992–1993. Morb Mort Weekly Rep 42:258–263, 1993. CDC. Foodborne outbreaks of enterotoxigenic Escherichia coli—Rhode Island and New Hampshire, 1993. Morb Mort Weekly Rep 43:81,87–89, 1994. CDC. Escherichia coli O157:H7 outbreak linked to commercially distributed dry-cured salami—Washington and California. Morb Mort Weekly Rep 44:157–160, 1995. CDC. Outbreak of Escherichia coli O157:H7 infection—Georgia and Tennessee, June 1995. Morb Mort Weekly Rep 45:249–251, 1996. CDC. Escherichia coli O157:H7 infections associated with eating a nationally distributed commercial brand of frozen ground beef patties and burgers—Colorado, 1997. Morb Mort Weekly Rep 46:777–778, 1997. CDC. Outbreaks of Escherichia coli O157:H7 infection associated with eating alfalfa sprouts—Michigan and Virginia, June–July 1997. Morb Mort Weekly Rep 46:741–744, 1997. CAST. Mycotoxins—economic and health risks. Rep. 116. Ames, IA: Council for Agricultural Science and Technology, 1989.

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3 The FDA’s GMPs, HACCP, and the Food Code Y. H. HUI Science Technology System, West Sacramento, California, U.S.A. WAI-KIT NIP University of Hawaii at Manoa, Honolulu, Hawaii, U.S.A. J. RICHARD GORHAM Consultant, Xenia, Ohio, U.S.A.

I.

INTRODUCTION

Nearly 25 years ago, the United States Food and Drug Administration (FDA) started the approach of using umbrella regulations to help the food industries to produce wholesome food as required by the Federal Food, Drug, and Cosmetic Act (the Act). In 1986, the FDA promulgated the ﬁrst umbrella regulations under the title of Good Manufacturing Practice Regulations (GMPR). Since then, many aspects of the regulations have been revised [1]. Traditionally, industry and regulators have depended on spot checks of manufacturing conditions and random sampling of ﬁnal products to ensure safe food. The current good manufacturing practice regulations (CGMPR) form the basis on which the FDA will inform the food manufacturer about deﬁciencies in its operations. This approach, however, tends to be reactive rather than preventive and can deﬁnitely be improved. For more than 30 years, FDA has been regulating the low-acid canned food (LACF) industries with a special set of regulations, many of which are preventive in nature. This action aims at preventing botulism. In the last 30 years, threats from other biological pathogens have increased tremendously. Between 1980 and 1995, FDA has been studying © 2003 by Marcel Dekker, Inc.

the approach of using hazard analysis and critical control points (HACCP). For this approach, FDA uses the LACF regulations as a partial guide. Since 1995, FDA has issued HACCP regulations (HACCPR) [2] for the manufacture or production of several types of food products. These include the processing of seafood and fruit/vegetable juices. Since 1938, when the Act was ﬁrst passed by Congress, FDA and state regulatory agencies have worked hard to reach a uniform set of codes for the national regulation of food manufacturing industries and state regulation of retail industries associated with food, e.g., groceries, restaurants, caterers, and so on. In 1993, the ﬁrst document, titled Food Code, was issued jointly by the FDA and state agencies. It has been revised twice since then. This chapter discusses CGMPR, HACCPR, and the Food Code. The appendices present: (a) the FDA’s good manufacturing practice regulations (complete); (b) guidelines for HACCP (complete); (c) the Food Code 2001 (Table of Contents only); and (d) an excerpt of the Handbook of Food Defect Action Levels.

II. CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS The current good manufacturing practice regulations cover the topics listed in Table 1. These regulations are discussed in detail here. Please note that the word shall in a legal document means mandatory and is used routinely in FDA regulations published in the U.S. Code of Federal Regulations (CFR). In this chapter, the words should and must are used to make for smoother reading. However, this in no way diminishes the legal impact of the original regulations. A.

Deﬁnitions (21 CFR 110.3)

The FDA has provided the following deﬁnitions and interpretations for several important terms. 1. Acid food or acidiﬁed food means foods that have an equilibrium pH of 4.6 or below. 2. Batter means a semiﬂuid substance, usually composed of ﬂour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.

Table 1 Contents of the Current Good Manufacturing Regulations 21 21 21 21 21 21 21 21 21 21

CFR CFR CFR CFR CFR CFR CFR CFR CFR CFR

110.3 110.5 110.10 110.19 110.20 110.35 110.37 110.40 110.80 110.93

Deﬁnitions Current good manufacturing practice Personnel Exclusions Plant and grounds Sanitary operations Sanitary facilities and controls Equipment and utensils Processes and controls Warehousing and distribution

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3. Blanching, except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for a sufﬁcient time and at a sufﬁcient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food. 4. Critical control point means a point in a food process where there is a high probability that improper control may cause a hazard or ﬁlth in the ﬁnal food or decomposition of the ﬁnal food. 5. Food includes raw materials and ingredients. 6. Food-contact surfaces are those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. Food-contact surfaces include utensils and food-contact surfaces of equipment. 7. Lot means the food produced during a period of time indicated by a speciﬁc code. 8. Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health signiﬁcance. The term undesirable microorganisms includes those microorganisms that are of public health signiﬁcance, that promote decomposition of food, or that indicate that food is contaminated with ﬁlth. 9. Pest refers to any objectionable animals or insects including, but not limited to, birds, rodents, ﬂies, and insect larvae. 10. Plant means the building or facility used for the manufacturing, packaging, labeling, or holding of human food. 11. Quality control operation means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated. 12. Rework means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food. 13. Safe moisture level is a level of moisture low enough to prevent the growth of undesirable microorganisms in the ﬁnished product under the intended conditions of manufacturing, storage, and distribution. The maximum safe moisture level for a food is based on its water activity, a w . An a w will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given a w will not support the growth of undesirable microorganisms. 14. Sanitize means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health signiﬁcance and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. 15. Water activity (a w) is a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. B. Personnel (21 CFR 110.10) Plant management should take all reasonable measures and precautions to ensure compliance with the following regulations. © 2003 by Marcel Dekker, Inc.

1.

2.

3.

4.

Disease Control. Any person who, by medical examination or supervisory observation, is shown to have an illness, open lesion, including boils, sores, or infected wounds, by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, should be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel should be instructed to report such health conditions to their supervisors. Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials should conform to hygienic practices while on duty. The methods for maintaining cleanliness include, but are not limited to, the following: a. Wearing outer garments suitable to the operation to protect against the contamination of food, food-contact surfaces, or food-packaging materials. b. Maintaining adequate personal cleanliness. c. Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate handwashing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. d. Removing all unsecured jewelry and other objects that might fall into food, equipment, or containers and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against their contamination of the food, food-contact surfaces, or food-packaging materials. e. Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material. f. Wearing, where appropriate, hairnets, headbands, caps, beard covers, or other effective hair restraints. g. Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed. h. Conﬁning the following personal practices to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco. i. Taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin. Education and Training. Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience to provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices. Supervision. Responsibility for assuring compliance by all personnel with all legal requirements should be clearly assigned to competent supervisory personnel.

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C. Plant and Grounds (21 CFR 110.20) 1. Grounds. The grounds surrounding a food plant that are under the control of the plant manager should be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds include, but are not limited to, the following: a. Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests. b. Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed. c. Adequately draining areas that may contribute contamination to food by seepage or foot-borne ﬁlth or by providing a breeding place for pests. d. Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed. If the plant grounds are bordered by grounds not under the operator’s control and not maintained in an acceptable manner, steps must be taken to exclude pests, dirt, and ﬁlth that may be a source of food contamination. Implement inspection, extermination, or other countermeasures. 2. Plant Construction and Design. Plant buildings and structures should be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes. The plant and facilities should a. Provide sufﬁcient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food. b. Take proper precautions to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, ﬁlth, or other extraneous material. The potential for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: location, time, partition, air ﬂow, enclosed systems, or other effective means. c. Taking proper precautions to protect food in outdoor bulk fermentation vessels by any effective means, including Using protective coverings Controlling areas over and around the vessels to eliminate harborages for pests Checking on a regular basis for pests and pest infestation Skimming the fermentation vessels as necessary d. Be constructed in such a manner that ﬂoors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from ﬁxtures, ducts, and pipes does not contaminate food, foodcontact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact. © 2003 by Marcel Dekker, Inc.

e. Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safetytype light bulbs, ﬁxtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage. f. Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, foodpackaging materials, and food-contact surfaces. g. Provide, where necessary, adequate screening or other protection against pests. D.

Sanitary Operations (21 CFR 110.35) 1.

2.

3.

4.

General Maintenance. Buildings, ﬁxtures, and other physical facilities of the plant should be maintained in a sanitary condition and should be kept in repair sufﬁcient to prevent food from becoming adulterated within the meaning of the Act. Cleaning and sanitizing of utensils and equipment should be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. Substances used in cleaning and sanitizing and in storage of toxic materials: a. Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures should be free from undesirable microorganisms and should be safe and adequate under the conditions of use. Compliance with this requirement may be veriﬁed by any effective means including purchase of these substances under a supplier’s guarantee or certiﬁcation or examination of these substances for contamination. Only the following toxic materials may be used or stored in a plant where food is processed or exposed: Those required to maintain clean and sanitary conditions Those necessary for use in laboratory testing procedures Those necessary for plant and equipment maintenance and operation Those necessary for use in the plant’s operations b. Toxic cleaning compounds, sanitizing agents, and pesticide chemicals should be identiﬁed, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. Pest Control. No pests should be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures should be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials. Sanitation of Food-Contact Surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, should be cleaned as frequently as necessary to protect against contamination of food.

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a. Food-contact surfaces used for manufacturing or holding low-moisture food should be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they should, when necessary, be sanitized and thoroughly dried before subsequent use. b. In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces should be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment should be cleaned and sanitized as necessary. c. Non–food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food. d. Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and should be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food-contact surfaces. e. Sanitizing agents should be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment. 5. Storage and Handling of Cleaned Portable Equipment and Utensils. Cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and manner that protects food-contact surfaces from contamination. E.

Sanitary Facilities and Controls (21 CFR 110.37)

Each plant should be equipped with adequate sanitary facilities and accommodations including, but not limited to, 1. Water Supply. The water supply should be sufﬁcient for the operations intended and should be derived from an adequate source. Any water that contacts food or food-contact surfaces should be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, should be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials or for employee sanitary facilities. 2. Plumbing. Plumbing should be of adequate size and design and adequately installed and maintained to a. Carry sufﬁcient quantities of water to required locations throughout the plant b. Properly convey sewage and liquid disposable waste from the plant c. Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition d. Provide adequate ﬂoor drainage in all areas where ﬂoors are subject to © 2003 by Marcel Dekker, Inc.

3. 4.

5.

6.

F.

ﬂooding-type cleaning or where normal operations release or discharge water or other liquid waste on the ﬂoor e. Provide that there is no backﬂow from, or cross-connection between, piping systems that discharge wastewater or sewage and piping systems that carry water for food or food manufacturing Sewage Disposal. Sewage disposal should be made into an adequate sewerage system or disposed of through other adequate means. Toilet Facilities. Each plant should provide its employees with adequate, readily accessible toilet facilities. Compliance with this requirement may be accomplished by a. Maintaining the facilities in a sanitary condition b. Keeping the facilities in good repair at all times c. Providing self-closing doors d. Providing doors that do not open into areas where food is exposed to airborne contamination, except where alternative means have been taken to protect against such contamination (such as double doors or positive airﬂow systems). Hand-Washing Facilities. Hand-washing facilities should be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing a. Hand-washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands b. Effective hand-cleaning and sanitizing preparations c. Sanitary towel service or suitable drying devices d. Devices or ﬁxtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands e. Readily understandable signs directing employees handling unprotected food, unprotected food-packaging materials, or food-contact surfaces to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may have become soiled or contaminated. These signs may be posted in the processing room(s) and in all other areas where employees may handle such food, materials, or surfaces. f. Refuse receptacles that are constructed and maintained in a manner that protects against contamination of food. Rubbish and Offal Disposal. Rubbish and any offal should be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces.

Equipment and Utensils (21 CFR 110.40) 1.

All plant equipment and utensils should be so designed and of such material and workmanship as to be adequately cleanable and should be properly maintained. The design, construction, and use of equipment and utensils should preclude the adulteration of food with lubricants, fuel, metal fragments, contami-

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3.

4.

5.

6.

7.

G.

nated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces should be corrosion resistant when in contact with food. They should be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces should be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. Seams on food-contact surfaces should be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms. Equipment that is in the manufacturing or food-handling area and that does not come into contact with food should be so constructed that it can be kept in a clean condition. Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, should be of a design and construction that enables them to be maintained in an appropriate sanitary condition. Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms should be ﬁtted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment and should be ﬁtted with an automatic control for regulating temperature or with an automatic alarm system to indicate a signiﬁcant temperature change in a manual operation. Instruments and controls used for measuring, regulating, or recording temperature, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food should be accurate and adequately maintained and adequate in number for their designated uses. Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment should be treated in such a way that food is not contaminated with unlawful indirect food additives.

Processes and Controls (21 CFR 110.80)

All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food should be conducted in accordance with adequate sanitation principles. Appropriate quality control operations should be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant should be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions should be taken to ensure that production procedures do not contribute contamination from any source. Chemical, microbial, or extraneous material testing procedures should be used where necessary to identify sanitation failures or possible food contamination. All food that has become contaminated to the extent that it is adulterated within the meaning of the Act should be rejected, or if permissible, treated or processed to eliminate the contamination. 1. Raw materials and other ingredients. a. Raw materials and other ingredients should be inspected and segregated or © 2003 by Marcel Dekker, Inc.

2.

otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and should be stored under conditions that will protect against contamination and minimize deterioration. Raw materials should be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food should be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food. b. Raw materials and other ingredients should either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they should be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act. Compliance with this requirement may be veriﬁed by any effective means, including purchasing raw materials and other ingredients under a supplier’s guarantee or certiﬁcation. c. Raw materials and other ingredients susceptible to contamination with aﬂatoxin or other natural toxins should comply with current FDA regulations, guidelines, and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into ﬁnished food. Compliance with this requirement may be accomplished by purchasing raw materials and other ingredients under a supplier’s guarantee or certiﬁcation, or may be veriﬁed by analyzing these materials and ingredients for aﬂatoxins and other natural toxins. d. Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material should comply with applicable FDA regulations, guidelines, and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be veriﬁed by any effective means, including purchasing the materials under a supplier’s guarantee or certiﬁcation or examination of these materials for contamination. e. Raw materials, other ingredients, and rework should be held in bulk or in containers designed and constructed so as to protect against contamination and should be held at such temperature and relative humidity as to prevent the food from becoming adulterated. Material scheduled for rework should be identiﬁed as such. f. Frozen raw materials and other ingredients should be kept frozen. If thawing is required prior to use, it should be done in a manner that prevents the raw materials and other ingredients from becoming adulterated. g. Liquid or dry raw materials and other ingredients received and stored in bulk form should be held in a manner that protects against contamination. Manufacturing operations. a. Equipment and utensils and ﬁnished food containers should be maintained in an acceptable condition through appropriate cleaning and sanitizing, as

© 2003 by Marcel Dekker, Inc.

b.

c.

d.

e. f.

g.

h.

i.

necessary. Insofar as necessary, equipment should be taken apart for thorough cleaning. All food manufacturing, including packaging and storage, should be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms or for the contamination of food. One way to comply with this requirement is careful monitoring of physical factors such as time, temperature, humidity, a w , pH, pressure, ﬂow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidiﬁcation, and refrigeration to ensure that mechanical breakdowns, time delays, temperature ﬂuctuations, and other factors do not contribute to the decomposition or contamination of food. Food that can support the rapid growth of undesirable microorganisms, particularly those of public health signiﬁcance, should be held in a manner that prevents the food from becoming affected. Compliance with this requirement may be accomplished by any effective means, including Maintaining refrigerated foods at 45°F (7.2°C) or below as appropriate for the particular food involved Maintaining frozen foods in a frozen state Maintaining hot foods at 140°F (60°C) or above Heat treating acid or acidiﬁed foods to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH, or controlling a w that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health signiﬁcance, should be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated. Work-in-process should be handled in a manner that protects against contamination. Effective measures should be taken to protect ﬁnished food from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they should not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food. Food transported by conveyor should be protected against contamination as necessary. Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food should be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination. Effective measures should be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means. Food, raw materials, and other ingredients that are adulterated should be disposed of in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it should be reconditioned using a method that has been proven to be effective or it

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j.

k.

l.

m.

n.

should be reexamined and found not to be adulterated before being incorporated into other food. Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming should be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces and by using time and temperature controls at and between each manufacturing step. Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched food is washed prior to ﬁlling, water used should be safe and of adequate sanitary quality. Batters, breading, sauces, gravies, dressings, and other similar preparations should be treated or maintained in such a manner that they are protected against contamination. Compliance with this requirement may be accomplished by any effective means, including one or more of the following: Using ingredients free of contamination Employing adequate heat processes where applicable Using adequate time and temperature controls Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them Cooling to an adequate temperature during manufacturing Disposing of batters at appropriate intervals to protect against the growth of microorganisms Filling, assembling, packaging, and other operations should be performed in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any effective means, including Use of a quality control operation in which the critical control points are identiﬁed and controlled during manufacturing Adequate cleaning and sanitizing of all food-contact surfaces and food containers Using materials for food containers and food-packaging materials that are safe and suitable Providing physical protection from contamination, particularly airborne contamination Using sanitary handling procedures Food such as, but not limited to, dry mixes, nuts, intermediate-moisture food, and dehydrated food, which relies on the control of a w for preventing the growth of undesirable microorganisms, should be processed to and

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o.

p.

q.

maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices: Monitoring the a w of food Controlling the soluble solids/water ratio in ﬁnished food Protecting ﬁnished food from moisture pickup, by use of a moisture barrier or by other means, so that the a w of the food does not increase to an unsafe level Food, such as, but not limited to, acid and acidiﬁed food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms should be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices: Monitoring the pH of raw materials, food-in-process, and ﬁnished food. Controlling the amount of acid or acidiﬁed food added to low-acid food. When ice is used in contact with food, it should be made from water that is safe and of adequate sanitary quality, and should be used only if it has been manufactured in accordance with current good manufacturing practice. Food-manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.

H. Warehousing and Distribution (21 CFR 110.93) Storage and transportation of ﬁnished food should be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container. I.

Natural or Unavoidable Defects in Food for Human Use that Present No Health Hazard (21 CFR 110.110) 1. Some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. The FDA establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action. 2. Defect action levels are established for foods whenever it is necessary and feasible to do so. These levels are subject to change upon the development of new technology or the availability of new information. 3. The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the ﬁnal food adulterated within the meaning of the Act, regardless of the defect level of the ﬁnal food. 4. A compilation of the current defect action levels for natural or unavoidable defects in food for human use that present no health hazard may be obtained from the FDA in printed or electronic versions.

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III. HAZARD ANALYSIS CRITICAL CONTROL POINTS REGULATIONS In 1997, FDA adopted a food safety program that was developed nearly 30 years ago for astronauts and is now applying it to seafood and fruit and vegetable juices. The agency intends to eventually use it for much of the U.S. food supply. The program for the astronauts focuses on preventing hazards that could cause foodborne illnesses by applying science-based controls, from raw material to ﬁnished products. The FDA’s new system will do the same. Many principles of this new system, now called hazard analysis and critical control points, are already in place in the FDA-regulated low-acid canned food industry. Since 1997, FDA has mandated HACCP for the processing of seafood, fruit juices, and vegetable juices. Also, FDA has incorporated HACCP into its Food Code, a document that gives guidance to and serves as model legislation for state and territorial agencies that license and inspect food service establishments, retail food stores, and food vending operations in the United States. The FDA now is considering developing regulations that would establish HACCP as the food safety standard throughout other areas of the food industry, including both domestic and imported food products. The National Academy of Sciences, the Codex Alimentarius Commission (an international, standard-setting organization), and the National Advisory Committee on Microbiological Criteria for Foods have endorsed HACCP. Several U.S. food companies already use the system in their manufacturing processes, and it is in use in other countries including Canada. A.

What is HACCP?

Hazard analysis and critical control points involves seven principles. 1.

2.

3.

4.

5.

6.

Analyze hazards. Potential hazards associated with a food and measures to control those hazards are identiﬁed. The hazard could be biological, such as a microbe; chemical, such as a toxin; or physical, such as ground glass or metal fragments. Identify critical control points. These are points in a food’s production—from its raw state through processing and shipping to consumption by the consumer—at which the potential hazard can be controlled or eliminated. Examples are cooking, cooling, packaging, and metal detection. Establish preventive measures with critical limits for each control point. For a cooked food, for example, this might include setting the minimum cooking temperature and time required to ensure the elimination of any harmful microbes. Establish procedures to monitor the critical control points. Such procedures might include determining how and by whom cooking time and temperature should be monitored. Establish corrective actions to be taken when monitoring shows that a critical limit has not been met—for example, reprocessing or disposing of food if the minimum cooking temperature is not met. Establish procedures to verify that the system is working properly—for example, testing time and temperature-recording devices to verify that a cooking unit is working properly.

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7. Establish effective recordkeeping to document the HACCP system. This would include records of hazards and their control methods, the monitoring of safety requirements and action taken to correct potential problems. Each of these principles must be backed by sound scientiﬁc knowledge such as published microbiological studies on time and temperature factors for controlling foodborne pathogens. B. Need for HACCP New challenges to the U.S. food supply have prompted FDA to consider adopting a HACCP-based food safety system on a wider basis. One of the most important challenges is the increasing number of new food pathogens. For example, between 1973 and 1988, bacteria not previously recognized as important causes of foodborne illness (such as Escherichia coli O157:H7 and Salmonella enteritidis) became more widespread. There also is increasing public health concern about chemical contamination of food, for example, the effects of lead in food on the nervous system. Another important factor is that the size of the food industry and the diversity of products and processes have grown tremendously, in both the amount of domestic food manufactured and the number and kinds of foods imported. At the same time, FDA and state and local agencies have the same limited level of resources to ensure food safety. The need for HACCP in the United States, particularly in the seafood industry, is further fueled by the growing trend in international trade for worldwide equivalence of food products and the Codex Alimentarius Commission’s adoption of HACCP as the international standard for food safety. C. Advantages and Plans The HACCP system offers a number of advantages over previous systems. Most importantly, HACCP Focuses on identifying and preventing hazards from contaminating food Is based on sound science Permits more efﬁcient and effective government oversight, primarily because the recordkeeping allows investigators to see how well a ﬁrm is complying with food safety laws over a period rather than how well it is doing on any given day Places responsibility for ensuring food safety appropriately on the food manufacturer or distributor Helps food companies compete more effectively in the world market Reduces barriers to international trade Here are the seven steps used in HACCP plan development: 1. Preliminary steps. a. General information. b. Describe the food. c. Describe the method of distribution and storage. d. Identify the intended use and consumer. e. Develop a ﬂow diagram. 2. Hazard analysis worksheet. a. Set up the Hazard Analysis Worksheet. © 2003 by Marcel Dekker, Inc.

3.

4.

5. 6. 7.

b. Identify the potential species-related hazards. c. Identify the potential process-related hazards. d. Complete the Hazard Analysis Worksheet. e. Understand the potential hazard. f. Determine if the potential hazard is signiﬁcant. g. Identify the critical control points (CCP). HACCP Plan Form a. Complete the HACCP Plan Form. b. Set the critical limits (CL). Establish monitoring procedures. a. What? b. How? c. Frequency? d. Who? Establish corrective action procedures. Establish a recordkeeping system. Establish veriﬁcation procedures.

It is important to remember that apart from HACCPR promulgated for seafood and juices, the implementation of HACCP by other categories of food processing is voluntary. However, the FDA and various types of food processors are working together so that eventually HACCPR will become available for many other food processing systems under FDA jurisdiction. Using the HACCPR for seafood processing as a guide, the following discussion for a HACCP plan applies to all categories of food products being processed in the United States. D.

Hazard Analysis

Every processor should conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of product processed by that processor and to identify the preventive measures that the processor can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent processor would establish controls because experience, illness data, scientiﬁc reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of product being processed in the absence of those controls. E.

The HACCP Plan

Every processor should have and implement a written HACCP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur. A HACCP plan should be speciﬁc to Each location where products are processed by that processor Each kind of product processed by the processor The plan may group kinds of products together or group kinds of production methods together if the food safety hazards, critical control points, critical limits, and procedures © 2003 by Marcel Dekker, Inc.

required to be identiﬁed and performed are identical for all products so grouped or for all production methods so grouped. 1. The Contents of the HACCP Plan The HACCP plan should, at a minimum, 1. List the food safety hazards that are reasonably likely to occur, as identiﬁed, and that thus must be controlled for each product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following: natural toxins; microbiological contamination; chemical contamination; pesticides; drug residues; decomposition in products where a food safety hazard has been associated with decomposition; parasites where the processor has knowledge that the parasite-containing product will be consumed without a process sufﬁcient to kill the parasites; unapproved use of direct or indirect food or color additives; and physical hazards. 2. List the critical control points for each of the identiﬁed food safety hazards, including, as appropriate, critical control points designed to control food safety hazards that could be introduced in the processing plant environment and critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest. 3. List the critical limits that must be met at each of the critical control points. 4. List the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits. 5. Include any corrective action plans that have been developed to be followed in response to deviations from critical limits at critical control points. 6. List the veriﬁcation procedures, and frequency thereof, that the processor will use. 7. Provide for a recordkeeping system that documents the monitoring of the critical control points. The records should contain the actual values and observations obtained during monitoring. 2. Signing and Dating the HACCP Plan The HACCP plan should be signed and dated either by the most responsible individual on site at the processing facility or by a higher-level ofﬁcial of the processor. This signature should signify that the HACCP plan has been accepted for implementation by the ﬁrm upon initial acceptance; upon any modiﬁcation; and upon veriﬁcation of the plan. 3. Sanitation Sanitation controls [3] may be included in the HACCP plan. However, to the extent that they are otherwise monitored, they need not be included in the HACCP plan. 4. Implementation This book is not the proper forum to discuss in detail the implementation of HACCPR. Readers interested in additional information on HACCP should visit the FDA HACCP website http://vm.cfsan.fda.gov/, which lists all the currently available documents on the subject. © 2003 by Marcel Dekker, Inc.

IV. THE FDA FOOD CODE The FDA Food Code (the Code) [4] is an essential reference that guides retail outlets such as restaurants and grocery stores and institutions such as nursing homes on how to prevent foodborne illness. Local, state, and federal regulators use the FDA Food Code as a model to help develop or update their own food safety rules and to be consistent with national food regulatory policy. Also, many of the over one million retail food establishments apply Food Code provisions to their own operations. The Food Code is updated every two years to coincide with the biennial meeting of the Conference for Food Protection. The conference is a group of representatives from regulatory agencies at all levels of government, the food industry, academia, and consumer organizations that work to improve food safety at the retail level [5]. A brief discussion of the Code is provided here. Further information, including access to the Code, may be obtained from the Food Safety Training and Education Alliance (www.fstea.org). The Code establishes deﬁnitions; sets standards for management and personnel, food operations, and equipment and facilities; and provides for food establishment plan review, permit issuance, inspection, employee restriction, and permit suspension. The Code discusses the good manufacturing practices for equipment, utensils, linens, water, plumbing, waste, physical facilities, poisonous or toxic materials, compliance, and enforcement. The Code also provides guidelines on food establishment inspection, HACCP guidelines, food processing criteria, model forms, guides, and other aids. A brief introduction to the Food Code in this chapter is important for two reasons: First, at the end of this book, two chapters cover retail food protection from the perspectives of food sanitation. The Food Code forms the backbone of these chapters. Second, although this guide is designed for retail food protection, more than half of the data included are directly applicable to food processing plants, e.g., equipment design (cleanability), CIP system, detergents and sanitizers, refrigeration and freezing storage parameters, water requirements, precautions against ‘‘backﬂow’’ (air, valve, etc.), personnel health and hygiene, rest rooms and accessories, pest control, storage of toxic chemicals, inspection forms, inspection procedures, and many more. Some of the data in the present book can be readily traced to the Code. The Code consists of eight chapters and seven annexes. Some of the information found in the Code will be further explored in two chapters at the end of this book. The annex that covers inspection of a food establishment applies equally as well to both retail food protection and to sanitation in food processing. According to the Code, the components of an inspection would usually include the following elements: Introduction Program planning Staff training Conducting the inspection Inspection documentation Inspection report Administrative procedures by the state/local authorities Temperature measuring devices Calibration procedures HACCP inspection data form Food establishment inspection report FDA electronic inspection system Establishment scoring © 2003 by Marcel Dekker, Inc.

Details of these items will not be discussed here; some are further explored in various chapters in this book (please consult the index for speciﬁc topics). Instead, the next two sections trace the history and practices of food establishment inspection and how basic sanitation controls are slowly evolving into the prerequisites for HACCP plans in both retail food protection and food processing plants. A. Purpose A principal goal to be achieved by a food establishment inspection is to prevent foodborne disease. Inspection is the primary tool a regulatory agency has for detecting procedures and practices that may be hazardous and for taking actions to correct deﬁciencies. Food Code–based laws and ordinances provide inspectors science-based rules for food safety. The Food Code provides regulatory agencies with guidance on planning, scheduling, conducting, and evaluating inspections. It supports programs by providing recommendations for training and equipping the inspection staff, and attempts to enhance the effectiveness of inspections by stressing the importance of communication and information exchange during regulatory visits. Inspections aid the food service industry in the following ways: 1. They serve as educational sessions on speciﬁc Code requirements as they apply to an establishment and its operation. 2. They convey new food safety information to establishment management and provide an opportunity for management to ask questions about general food safety matters. 3. They provide a written report to the establishment’s permit holder or person in charge so that the responsible person can bring the establishment into conformance with the Code. B. Current Applications of HACCP Inspections have been a part of food safety regulatory activities since the earliest days of public health. Traditionally, inspections have focused primarily on sanitation. Each inspection is unique in terms of the establishment’s management, personnel, menu, recipes, operations, size, population served, and many other considerations. Changes to the traditional inspection process were ﬁrst suggested in the 1970s. The terms ‘‘traditional’’ or ‘‘routine’’ inspection have been used to describe periodic inspections conducted as part of an ongoing regulatory scheme. A full range of approaches was tried and many were successful in managing a transition to a new inspection philosophy and format. During the 1980s, many progressive jurisdictions started employing the HACCP approach to refocus their inspections. The term ‘‘HACCP approach’’ inspection is used to describe an inspection using the hazard analysis and critical control point concept. Food safety is the primary focus of a HACCP approach inspection. One lesson learned was that good communication skills on the part of the person conducting an inspection are essential. The FDA has taught thousands of state and local inspectors the principles and applications of HACCP since the 1980s. The State Training Branch and the FDA Regional Food Specialists have provided two-day to week-long courses on the scientiﬁc principles on which HACCP is based, the practical application of these principles including ﬁeld exercises, and reviews of case studies. State and local jurisdictions have also offered many training opportunities for HACCP. © 2003 by Marcel Dekker, Inc.

A recent review of state and local retail food protection agencies shows that HACCP is being applied in the following ways: 1.

2.

3. 4. 5. 6.

Formal Studies. Inspector is trained in HACCP and is using the concepts to study food hazards in establishments. These studies actually follow foods from delivery to service and involve the write-up of data obtained (ﬂow charts, cooling curves, etc.). Routine Use. State has personnel trained in HACCP and is using the hazard analysis concepts to more effectively discover hazards during routine inspections. Consultation. HACCP-trained personnel are consulting with industry and assisting them in designing and implementing internal HACCP systems and plans. Alternative Use. Jurisdiction used HACCP to change inspection forms or regulations. Risk-Based. Jurisdiction prioritized inventory of establishments and set inspection frequency using a hazard assessment. Training. Jurisdiction is in the active process of training inspectors in the HACCP concepts.

Personnel of every sort of food establishment should have one or several copies of the Food Code readily available for frequent consultation. V.

APPLICATION TO FOOD PLANT SANITATION

The sanitary requirements in the CGMPR and the Food Code serve as the framework for the chapters in this book. The HACCPR will be touched on when they help to clarify the discussion. Essentially, this book shows how to implement the umbrella regulations provided under the CGMPR. Each chapter handles one aspect of these complicated regulations. Most chapters discuss the regulations applicable to all types of food products being processed. Several chapters concentrate on the sanitary requirements from the perspectives of the processing of a speciﬁc category of food. The appendix of this book reproduces the complete coverage of CGMPR in 21 CFR 110. REFERENCES 1. FDA. Title 21, Code of Federal Regulations, Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. Washington, DC: U.S. Government Printing Ofﬁce, 2001. 2. FDA. Title 21, Code of Federal Regulations, Part 120, Hazard Analysis and Critical Control Point (HACCP) Systems. Washington, DC: U.S. Government Printing Ofﬁce, 2001. 3. CM Nolan. Developing an integrated sanitation program using innovative techniques. Food Safety Magazine 7(4):18,19,21,39,40,43,44, 2001. 4. FDA. Food Code. Washington, DC: U.S. Department of Health and Human Services, 2001. 5. G Lewis, PA Salisbury. Safe food at retail establishments. Food Safety Magazine 7(4):13–17, 2001.

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4 Food Plant Inspections ALFRED J. ST. CYR AIB International, Manhattan, Kansas, U.S.A.

I.

INTRODUCTION

Food manufacturing plants continue to increase in complexity, and the potential for issues to develop that adversely affect the consumer increase accordingly. To avoid being in a negative spotlight, food plants have developed numerous programs and policies designed to meet their challenges. Good manufacturing practice (GMP) policies, hazard analysis and critical control point (HACCP) programs, plant policies and practices, production parameters, preventive maintenance programs, and sanitation/hygiene programs, along with others, assist facilities in meeting their obligations. One critical program that must be in place to verify that all objectives are being met on a consistent basis includes plant inspections [1]. Plant inspections are used by several different entities to achieve the same goal. Regulatory agencies utilize plant inspections for the enforcement of food laws. A company’s customers utilize inspections to determine the risks of doing business with a particular ﬁrm, using either their own resources or a third-party professional organization, to conduct the inspection. Perhaps the most important aspect of the inspection program, however, is the self-inspection program undertaken by a facility’s own personnel to monitor the conditions in the plant. Personnel must identify potential food safety risks and take actions to correct deﬁciencies that develop. The internal inspection process should be conducted by a well-organized committee dedicated to ensuring a high level of compliance with all the plant’s internal policies and all external requirements (those of business partners, federal and state regulatory agencies, etc.) [2]. The committee usually consists of management personnel from production, plant sanitation and maintenance, as well as from the quality control and human resources departments. More and more often, the committee includes hourly employees, who have an © 2003 by Marcel Dekker, Inc.

equal commitment to the success of the plant. The mix of these various personnel offers the committee the opportunity to view the plant from different perspectives and to evaluate the programs using a more comprehensive approach. Often the plant manager will participate in the process to lend a higher visibility to the program as well as to accelerate the corrective actions needed. Once the committee members have been selected, their responsibility becomes one of assessing what has been neglected and also compiling a report detailing solutions to the food safety risks identiﬁed. Generally, these risks are beyond the capability or authority of the individual responsible for the area of concern. This report, called a Corrective Action Report, requires a speciﬁc action to be taken within a designated time frame. It also allows for follow-up actions since the issue remains open until it has been corrected.

II. PLANT POLICIES Food plants can expect regulatory agencies, customers, and even corporate personnel (both in-house inspectors and inspectors from supplier companies) to conduct evaluations of plant operations and conditions (see Chapter 21). This is often an inconvenience and sometimes a traumatic experience. The better prepared your facility is to meet these challenges, the less likely your personnel will be tense and make costly mistakes by providing the wrong information or behave in a manner that raises concerns. Each facility should be prepared ahead of time by having a clearly written and understood policy concerning inspections by outside personnel. The policy should include and spell out clearly what actions are to be taken and by whom when an inspector arrives at the facility. Policies concerning photographs, samples, and records that can be reviewed with inspectors must be clear to give personnel the proper guidance. Policies should indicate the member of the management team to accompany the inspectors and answer the questions. The personnel assigned this responsibility should be familiar with the policy and their responsibilities and should be able to outline the ﬁrm’s policies for the inspectors during the initial meeting. Having clear policies that are understood by all parties can help you avoid costly misunderstandings and controversy during the inspections. Encountering a facility that is clearly in control of this aspect of their operations sends a very positive message to any investigator regarding the commitment and understanding of the obligation a ﬁrm has when manufacturing food. Rarely is an inspection of your facility a pleasant experience; however, it can go relatively smoothly if you take the time to be prepared.

III. REGULATORY INSPECTIONS The Food, Drug, and Cosmetic Act of 1938 allows for the inspection of food manufacturing plants by government investigators from various federal, state, and local health agencies to determine if the facility complies with the current statutes. The authority to conduct the inspections was further supported by the United States vs. Dotterweich decision (U.S. Supreme Court 1943, 320 U.S. 277,64S.CT 134) rendered by the high court in 1948. The federal inspection program is divided between the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). Though each is charged with different responsibilities, they share the common goal of protecting the health and welfare of the American consumer. © 2003 by Marcel Dekker, Inc.

It is important to understand that a visit by an investigator from a government agency such as the FDA is the beginning of a legal process—speciﬁc protocols must be followed. Both parties have speciﬁc rights or privileges granted under the law that must be respected. Since the FDA commonly inspects a variety of food manufacturing plants, we will review the process commonly followed by that agency (the USDA programs are aimed mainly at the meat and poultry industries). The initial visit by an investigator from the FDA is likely to be an unannounced event. The investigator (the number varies from one to several) will arrive at the facility during what has been determined as reasonable business hours, which can mean that inspectors can arrive any time the business is open. However, since the visit will likely require contact with senior management personnel, the investigator will normally arrive at some point during typical business hours unless there is a signiﬁcant urgency to the issue. Security personnel, if they are the ﬁrst company personnel encountered, should direct the investigator to the proper reception area. Though every effort should be made to expedite the investigator meeting with the correct personnel, certain protocols should be met. Every investigator should present his or her ofﬁcial identiﬁcation credentials prior to proceeding beyond this point. If not voluntarily provided, these should be requested. Inquiries should be made concerning the reason behind the visit. This will likely produce FDA form 482, ‘‘Notice of Inspection,’’ that will state that the investigator is there to conduct an inspection of the facility and that this is the beginning of the process. The form will not state whether the investigation is for routine GMP compliance or whether a speciﬁc violation is being investigated. It is important to ask the investigator for this information. The vast majority of investigations conducted by the FDA are considered routine as required by law. However, due to the complexities of food manufacturing in the United States, conditions found in one distribution center or manufacturing facility may lead investigators to your facility in their effort to determine the extent and/or source of a particular risk to the public health. This may involve tracking an infestation or a contamination issue introduced into interstate commerce. An excellent guide to help you understand what inspectors are likely to evaluate in your facility is available in the manual ‘‘Inspectional Methods Taught by FDA: Inspections by Speciﬁc Food Categories’’ [3]. Regardless of the reason for the inspection conducted by outside personnel, it is important to have only one spokesperson for your ﬁrm. This policy can reduce the potential for confusion and misunderstanding between parties. In addition, if the spokesperson is not familiar with the information requested, he or she should so state and then get back to the inspector after obtaining the correct information. At the conclusion of the FDA inspection, the investigator will issue a ‘‘List of Observations’’ (form 483) and present the observations to management prior to leaving the facility. This form should be carefully reviewed and any points that appear unclear or incorrect should be corrected with the investigator at that time. All corrections completed during the visit should also be noted on this form. It is very important that management take appropriate action to ensure that a repeat of the issues noted does not occur on subsequent inspections. The inspectors may take samples of ﬁnished products, in-process ingredients, or other sources of evidence such as insects or insect fragments, foreign matter, or rodent evidence during an inspection. The FDA will provide you with a ‘‘Receipt for Samples’’ (form 484) for the samples taken during the course of the inspection. It is important that © 2003 by Marcel Dekker, Inc.

you obtain a sample from the same source. The best option is to split the sample taken by the FDA investigator. Find out what tests will be conducted on the samples and then expedite having your samples tested by an independent laboratory using the same methods outlined by the investigator. IV. SELF-INSPECTION PROGRAM The preceding section outlined the legal aspects of the inspection process. There is little doubt that any person involved in any way with the production, storage, and distribution of food items has a legal responsibility to comply with the established regulatory statutes. Though important, the legal requirements cover only part of the issues. We cannot overlook the moral obligation that we in the food industry have to those who purchase and consume our products. All of us are dependent on other people to provide us with safe, wholesome products. The impact of failing to meet the expectations of our customers and putting their health and welfare at risk often results in a far more severe economic impact on business than the ﬁnes imposed by regulatory agencies. To avoid events that lead to failures, an effective food safety program should be designed with attention to the interrelationships between all departments in the food plant and between management and hourly employees. When you consider that the number of employees represents the number of opportunities for program success or failure, it pays to invest in each employee to ensure your success. Only when all employees personally accept the responsibility for the products under their control and accept that they will be held accountable for their actions can we truly succeed. A.

Preparing for Self-Inspections

One common excuse used to justify the failure of a viable self-inspection program is a lack of time to do the inspection. Adequate preparation and notiﬁcation of the members of the committee designated to conduct the inspection can reduce the time required to conduct the inspections and ensure that they are carried out with sufﬁcient detail in order to identify and correct potential food safety issues. Since the self-inspection program is an extension of employee training programs and is also used to assess the needs of the facility, the conduct of the inspection committee members is critical to the success of the program. Having the tools (ladders, manlifts, keys for access, etc.) available ahead of time and discussing issues identiﬁed with area employees can only improve the acceptance of the program and participation by everyone. Conducting a good inspection requires considerably more than collecting a long list of issues for someone to correct. Far too often, without proper training of the inspectors, the process becomes bogged down in personal conﬂicts. The task requires a person to review a situation, identify the deﬁciency, determine a corrective action, and follow through to its implementation. Perhaps the two most important things a person can bring to the self-inspection process are a blank mind and a blank notepad to document the ﬁndings. If you embark on an inspection tour of the facility looking for speciﬁc issues, you will likely ﬁnd those issues. However, there may be other signiﬁcant issues you overlook in your pursuit because your mind’s eye is closed to them. Since no one has perfect memory, the notepad allows you to document the issues you identify and thus facilitate follow-up by the proper personnel. © 2003 by Marcel Dekker, Inc.

Proper note taking during inspections is a difﬁcult task in itself. The inspection notes are your primary method of conveying your concerns to others. You will, subsequently, have to prioritize the corrective actions required to remedy the various defects observed. At a minimum, the notes you take to document the ﬁndings should include what was wrong, why you felt it was an issue, a suggestion for correction, and, perhaps most important, the exact location in the facility where the observation was made. Understand very clearly that the personnel reading your inspection report were likely not with you; so your task is to create, through the least amount of words, an image that motivates them to corrective action. Always provide the facts clearly. Poorly written inspection reports incorporating inaccurate or misleading comments may very well compromise the company’s conﬁdence in both the self-inspection program in the inspector conducting it. Also useful during facility inspections are simple tools that permit you to make clearer observations. Aside from dressing properly for conducting an inspection by including safety shoes and safety equipment required by plant policy and having maintenance resources available, other tools that may be useful to help identify opportunities include Bright ﬂashlight Various spatulas Screwdrivers Extension inspection mirrors Small adjustable wrench Other specialized tools for the operation Individual systems may require speciﬁc tools to obtain access. Regardless of the plant or system you are inspecting, communication and following safety protocols are imperative. Rely on the operators to provide access to equipment since they likely have a very comprehensive knowledge of the system. Rely on them as a resource for information to answer your questions. Since their participation is critical to the success of the programs, involving them in the inspection process is an opportunity to provide instruction and solicit their cooperation. B. Inspecting the Plant Though individual inspectors would appear to have their own unique techniques for inspecting a food plant, close observation of their work will reveal that most of them pursue a logical path, following the production process either from start to ﬁnish or vice versa. Doing so can often make it easier for those reading the ﬁnal report to better visualize the ﬂow the inspection took and improve their understanding of the issues noted. Usually, inspectors will follow the ﬂow of production from beginning to end. However, there are a few exceptions to this practice that you must consider. First, there may be microbiological considerations in the process that would not allow you to start at the beginning of a process. A facility such as a dairy would require that the raw milk receiving area be inspected at the conclusion of the inspection to avoid the potential for transfer of a microbiological contaminant from this area to the remainder of the facility. You may encounter similar issues in other processes where beginning the inspection in the ﬁnal processing areas would be the most appropriate. C. Raw Material Receiving The raw material receiving area of the facility requires a thorough review of the materials stored there and also close observation of the procedures followed to allow materials to © 2003 by Marcel Dekker, Inc.

be accepted into the food plant. Each ingredient or material arriving from outside the plant must be treated as suspect and treated as though each offers the potential for the introduction of a problem. Personnel in these receiving areas must become familiar with the potential problems they may encounter and be vigilant in their inspection of incoming materials and the vehicles in which they arrived. The inspection of raw materials in the storage warehouse provides an excellent opportunity to further identify issues with suppliers and must be paid the appropriate attention. By its design, this area of the plant houses all of the materials acquired from countless ‘‘unknown’’ sources. No other area of the plant provides a higher risk for hazards to impact the plant. Conﬁrm that all of the programs the facility has developed to identify and correct issues regarding receipt of raw materials from suppliers are in place and followed. Verify proper dating or coding of materials and ensure that storage practices conform to the requirements of the product and the facility. Particular attention should be paid to the receipt documentation and pest control records for these areas to attempt to identify trends that may have developed with a particular product or supplier. Insect monitoring devices such as insect light traps and pheromone traps should certainly be regarded as valuable sources of information. Inspection of the area around the incoming products should be undertaken with a three-dimensional approach. Too often we tend to limit ourselves to the easily accessible areas or fail to fully identify the extent of an issue because the scope of the search was equally limited. By making observations from an elevated vantage point that provides a broad overview of a certain section of the facility, the inspector may be able to identify a breakdown of a speciﬁc program or a potentially serious isolated issue that might go unobserved at ground level. In a storage area for ingredients, for example, the observation of dust and debris accumulations on numerous pallet stacks might signal a widespread defect in stock rotation or cleaning programs. By spotting just one pallet stack that appears to be out of sequence in the stock rotation system, the inspector is prompted to call attention to a speciﬁc issue that may have escaped the attention of the responsible plant personnel. It is well worth the effort while you are in this area of the plant to inspect and conﬁrm the use of the product safety devices established to monitor incoming materials. Sifters, strainers, magnets, metal detectors, ﬁlters, and other devices should be closely examined and their documented records checked to determine if failures have occurred and actions taken in response to these failures. This task is one that provides the opportunity to involve the area personnel in the inspection process and enables them to demonstrate their capabilities and participation in the overall product safety program. D.

Production Areas

The production areas of factories offer a variety of challenges and opportunities. Often congested with equipment and in a state of haste, extra caution is required by the individual inspecting these areas. Even the most knowledgeable employees have been known to make simple errors of judgment that have caused serious injury. Always be aware of and concerned about the effect your actions may have while working in busy areas of the facility. Though a human brain is indeed a marvelous tool, it has limitations. A limited © 2003 by Marcel Dekker, Inc.

amount of data can be taken in, processed, analyzed, and interpreted. The volume of data challenging the inspector in the production/processing area can be overwhelming. We may believe we are making a comprehensive survey of an area when we attempt to scan the entire area at one time, but in reality our mind’s eye tends to deceive us about how little we actually see. To overcome this, the inspector should break down (or cube) the area into small, manageable parts to better evaluate conditions, with smaller volumes of data handled individually rather than as a whole. To accomplish this, simply establish boundaries in a given room and thoroughly evaluate that space before moving on to the adjacent space. Use a piece of equipment or any solid object to help you focus on that object and the surrounding space before moving on to the next piece of equipment. A primary objective of the inspection conducted in processing areas is often to establish that all of the policies and procedures in place are in fact being followed. Personnel given this responsibility need to recognize that their greatest asset is their ability to observe and then to correlate the observations with the sum total of the processing operations. To do so, the auditor must have a comprehensive understanding not only of the guidelines established within the organization, but also of the potential impacts of nonconformance with those guidelines. This knowledge becomes increasingly relevant when the time for corrective action requires the participation of the production area employees. Your ability to explain the deﬁciency and what will be required for correction in a logical and meaningful way to the personnel working in a given area will likely facilitate implementation of the correction far more quickly than if it is perceived that you do not know what you are talking about. When you can relate the need for change in such a way that the responsible employee sees it as a personal advantage, then compliance with the change easily follows. Recognize that the production facility changes throughout the day and that inspections conducted at various times will likely reveal different issues. This is partially dictated by the access you have to the systems at various times. Realizing this, the plant inspection program should be conducted during the different shifts in an attempt to obtain a varied assessment of conditions in the operation. E.

Production Periods

Inspections conducted in production areas during production periods offer an opportunity to observe personnel practices and the operational methods employed, as well as the overall state of repair of the facility, systems integrity, and policy compliance. Since personnel are often a source of concern, time spent on the production ﬂoor during these periods is extremely valuable. However, recognize the limitations you will encounter if your objective is to inspect the condition of the production equipment; access to critical elements of the system will probably not be available for inspection except during production downtime. The inspection of the processing areas encompasses the GMP issues. Due to lack of available time and scheduling constraints that do not allow for separate and distinct evaluations, many companies combine both GMP and production/processing evaluations in abbreviated formats to be conducted during the same visit to the facility. More detailed audits can then be performed if the information collected warrants further action. This is especially the case when there is a critical process control that also involves a food safety © 2003 by Marcel Dekker, Inc.

risk. Veriﬁcation that processes are being held within the critical limits established for the product, as well as verifying the integrity of the system, is often incorporated into the inspection process [4]. F.

Packaging Areas

Special attention is required when inspecting the packaging area of any facility. This area is the last point in the process where you have the opportunity to remove those products not conforming to established speciﬁcations. Your inspection should focus on the ability of the systems used to identify failures (magnets, metal detectors, sieves, etc.) and the level of compliance by area personnel in the proper monitoring of these systems. The inspection process should provide for a very thorough review to identify any and all possible defects that might pass through the system and to ensure that they are detected and corrected. It should be standard practice to test the metal detection equipment and verify its effective operation by using the appropriate test blanks (see also Chapter 23). You should conﬁrm that area personnel responsible for the validation procedures follow the proper test protocols and, if necessary, then make sure that these same people make the appropriate adjustments. In addition, the inspection procedures should include a veriﬁcation of code date systems and proper packaging for the products. Packaging systems, ventilation systems, and electrical elements have become increasingly complex and are often sensitive to the intrusion of untrained personnel performing routine inspections. Due to these complexities, many plant managers are reluctant to allow access to these systems frequently enough to insect infestations or other sources of contamination to develop. To limit the potential for these unwanted outcomes to occur, you must provide training to develop the skill level and competence of the personnel in these areas. G.

Support Areas

Though often overlooked or de-emphasized during plant inspections, support areas can have a signiﬁcant impact on the rest of the facility. Many inspectors will gauge the level of tolerance for policy compliance by the way the mechanical or utility areas are maintained. A general lack of GMP or plant policy compliance identiﬁed in these areas will often raise suspicions in other areas as well. All plant policies should be uniformly applied throughout the facility. Such areas should be checked closely for the presence of pest activity or personnel practices that could lead to contamination by chemical, physical, or microbiological means. H.

Exterior Areas

Failure to inspect the exterior areas of a food plant could lead to serious consequences. Often, infestation issues can be traced directly to conditions that exist in these areas or to a system failure. For example, a ventilation system that is in need of repair and no longer provides the barrier protection it was designed for is a system failure. Ignoring these areas can lead to serious food safety issues. The inspection of the exterior should include the grounds along the immediate building exterior (see also Chapters 19 and 20). Also inspect the grounds as far out from the building as necessary to identify unwanted conditions such as water sources, habitats conducive to pest activity, or undesirable practices by personnel. Occasionally, the inspector © 2003 by Marcel Dekker, Inc.

may have to consider surrounding properties as potential sources of hazards; a strategy must be developed to reduce their impacts on the food plant. The entire structure, including the roof, should receive close scrutiny to determine if the proper barriers to exclude potential hazards are in place. Often, the roof is overlooked as a contributor to rodent and insect activity experienced in the plant. Data collection systems, such as mechanical rodent traps, will passively but efﬁciently monitor these areas. These data then, when analyzed, will provide direction for the actions needed (see also Chapter 17). V.

INSPECTION TIPS

Through experience, inspectors realize that regardless of how thorough they are, not every issue will be identiﬁed during each inspection. More apparent issues often hide critical issues. The hidden issues will not be identiﬁed until the less critical items have been eliminated. No inspector, whether new or a seasoned veteran, should be discouraged when this happens. Understand that the plant is in a constant state of change and issues do not always present themselves in the same manner. The inspection becomes a means of discovery and should be conducted frequently enough to allow you to improve and move forward. The greatest asset an inspector can possess is knowledge. Whether your specialty is microbiology, entomology, engineering, or even human resources, proper application of your knowledge during the inspection will lead you to the signiﬁcant issues. An accumulation of wet debris may catch the interest of the microbiologist because of the microbiological issues. An entomologist would regard the same issue as a potential pest harborage. The individual from the human resources department may look at it as the failure of an employee to follow standard procedures. Regardless of specialty, all would be drawn to the issue and would, subsequently, make an effort to correct the basic problem. Use the skills you possess and build on them. Here are a few examples of how to expand your information sources during an inspection. Don’t be hesitant to ‘‘look up’’ when evaluating the possible location of the source of insect activity found at ﬂoor level. Recent cleaning efforts in the area may have dislodged a population of insects and, though they were found on the ﬂoor, the source may be far more extensive than it ﬁrst appears. Repeated observations of insect activity along an area adjacent to a wall may require you to access the interior of the wall to check the void space for product accumulation and infestation. Your knowledge of the building structure will help with the evaluation of this type of issue. High microbe counts in a sensitive area would likely lead you to look for areas where water is present. Closely inspect areas that would not normally be considered as wet, such as ducting for ventilation or dust collection systems. Due to changes in diameter or direction of the ductwork, product and/or moisture may collect and cause problems. Never overlook an opportunity to inspect a void space in the building or in equipment. Void spaces, regardless of the size, often provide harborages for pests. They may also serve as unauthorized storage areas for personnel. Examination of these areas should become a routine practice during plant inspections. Many inspectors routinely check the insect light traps for the source of insects found © 2003 by Marcel Dekker, Inc.

in a certain area. In the absence of the traps, overhead lighting with shatterproof globes or shields is another good area to check for insects. Insect activity found in these units may lead to the discovery of ventilation ﬁlters in need of adjustment or replacement or a recent opening created in an exterior wall. Employee practices, such as the excessive use of tape or other materials to repair equipment, should be recognized as an issue. In this case there are perhaps two issues needing attention: a lack of adequate training and a need to improve the overall maintenance program. Often, observing employee behavior and practices provides insight into the status of these programs. Take full advantage of all clues that come to you, directly or indirectly, from the efforts of other plant personnel. For example, inspect the interior of vacuum cleaners and trash bags. The materials collected in these receptacles sometimes yield evidence of GMP or sanitation issues, such as an insect infestation, that have otherwise gone unobserved in a particular part of the facility. A vacuum cleaner inspected after a cleanup period will give you an overview of the level of infestation in a general area based on the number of insects concentrated in the collection reservoir. When you are presented with an opportunity to take an issue at face value or to investigate, choose to investigate. A thorough evaluation of any issue promotes your credibility and, in most cases, conﬁrms your ﬁrst impression that an issue was present and required attention. As stated at the beginning of this chapter, the plant inspection is designed to provide an overview of the condition of the facility. To do this effectively in the limited time normally available to the inspector, the use of all disciplines and resources possessed by the inspector are required. This book in its entirety provides an excellent source of information for the various programs that should be in place in any food manufacturing facility. Use the information as a guide and as a means to expand your abilities. REFERENCES 1. American Institute of Baking. Basic Food Plant Sanitation Manual, 3rd Ed. Manhattan, KS: American Institute of Baking, 1979. 2. JL Vetter. Food Laws and Regulations. Manhattan, KS: American Institute of Baking, 1996. 3. American Institute of Baking. Inspectional methods taught by FDA: inspections by speciﬁc food groups [abstracted from FDA operational manual available at www.FDA.gov.ora.inspect ref]. Manhattan, KS: American Institute of Baking. 4. FDA. Title 21, Code of Federal Regulations, Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. Washington, DC: U.S. Government Printing Ofﬁce, 2000, pp 208–217.

© 2003 by Marcel Dekker, Inc.

5 Hard or Sharp Foreign Objects in Food ALAN R. OLSEN U.S. Food and Drug Administration, Washington, D.C., U.S.A. MICHAEL L. ZIMMERMAN U.S. Food and Drug Administration, Albuquerque, New Mexico, U.S.A.

I.

INTRODUCTION

A. Foreign Objects as Physical Hazards Foreign objects in foods are considered adulteration under the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [1]. Foreign objects can be broadly classiﬁed as hazardous (e.g., glass) or nonhazardous (e.g., ﬁlth). Some hard or sharp objects in food are physical hazards that may cause traumatic injury including laceration and perforation of tissues of the mouth, tongue, throat, stomach, and intestine as well as damage to the teeth and gums. A food that contains physically hazardous foreign objects is deemed adulterated under Section 402(a)(1) of the FD&C Act in that ‘‘it bears or contains any poisonous or deleterious substance which may render it injurious to health.’’ B. Naturally Occurring Hard Objects Section 402(a)(1) of the FD&C Act applies only to ‘‘an added substance.’’ Hard or sharp natural components of a food (e.g., bones in seafood, pits in whole olives) are unlikely to cause injury because of awareness on the part of the consumer that the component is a natural and intrinsic component of a particular product. The exception occurs when the food’s label represents that the hard or sharp component has been removed from the food. The presence of naturally occurring hard or sharp objects in those situations (e.g., pit fragments in pitted olives) is unexpected and may cause injury. The U.S. Food and Drug Administration (FDA) has established Defect Action Levels (DALs) [2] for many of these types of unavoidable defects. © 2003 by Marcel Dekker, Inc.

C.

Foreign Objects as Nonhazardous Filth

Not all foreign objects are physical hazards. For example, tiny metal shavings sometimes generated by opening cans with a can opener do not normally pose a physical hazard. Other types of foreign objects that are not categorized as physical hazards include insects and mites and their fragments, evidence of rodents and birds such as their excreta, hairs and feathers, and molds and rots associated with decomposition and dirty machinery parts. Foods containing these types of nonhazardous foreign matter may be deemed adulterated under Section 402(a)(3) of the FD&C Act in that ‘‘it consists in whole or in part of any ﬁlthy, putrid, or decomposed substance’’ or ‘‘it is otherwise unﬁt for food.’’ II. HAZARDOUS FOREIGN OBJECTS A.

FDA Deﬁnition of a Physical Hazard

A foreign object in food is categorized as a physical hazard if it meets all of the following criteria: There is clinical evidence of physical trauma or injury from ingestion. Medical authorities recognize the type of object as a potential ingestion hazard. Subsequent processing or intended use of the product does not eliminate or neutralize the hazard. These criteria apply to all types of physical hazards, including hazards from hard foreign objects, from sharp foreign objects, and from objects that pose a choking hazard. B.

Hard or Sharp Foreign Objects

The most common type of physical hazard from foreign objects that are encountered in food products is the injury or trauma hazard from hard or sharp foreign objects [3]. According to FDA Compliance Policy Guide 555.425, any hard or sharp foreign object that is 7 mm or larger is a potential physical hazard in food [4]. This guideline does not apply to the naturally occurring hard foreign objects as described under Sec. I.B. Two additional conditions are included in the Compliance Policy Guide. The ﬁrst condition provides that a foreign object is not a physical hazard if the processing or intended use of the food would remove the hazard (e.g., ﬁltration). Intended use and processing steps that would remove or neutralize a hazard are important considerations when evaluating the likelihood of a hazard occurring. The second condition provides that if a product is intended for use by a special risk group (e.g., elderly, infants), then foreign objects as tiny as 2 mm, or even smaller, could be a potential physical hazard. C.

Choking Hazards

There are no clear science-based parameters for what constitutes a choking hazard from foreign objects in food. Research in the area of choking hazards is mainly concerned with establishing size criteria above which an object is unlikely to be mouthed or swallowed by small children [5]. The Consumer Product Safety Commission (CPSC) has established a safety standard for small parts in toys that may serve as a general standard for comparison when dealing with foreign objects that are larger than the 25-mm CPSC standard [6]. The CPSC standard deﬁnes what size of an object is too large to be accidentally swallowed © 2003 by Marcel Dekker, Inc.

by small children but does not address the question of how small an object must be in order to be considered nonhazardous in this regard. D. Other Agencies The FDA criteria and guidance regarding physical hazards from hard or sharp foreign objects in food are consistent with guidance from other government agencies that are concerned with food safety. The United States Department of Agriculture (USDA) categorizes hard or sharp objects over 7 mm in length as potentially hazardous, while objects that measure between 2 and 7 mm are normally considered a nonhazardous defect [7]. Health Canada recognizes foreign objects 2 mm or greater as being a potential physical hazard. E.

Potential Sources of Physical Hazards

Three major sources of physical hazards involving foreign objects are (1) foreign objects in raw materials, (2) objects that break off containers, processing machinery, or other equipment in the plant, and (3) objects associated with maintenance operations (e.g., glass from unshielded light bulbs). Food manufacturers and processors must be aware of these possible sources of physical hazards and be prepared to take proactive measures to prevent the hazards from occurring. F.

Analytical Considerations

The analytical techniques for detecting potentially hazardous foreign objects in food rely on visual examination of product samples [8] and on sedimentation methods that separate food components from heavier or denser foreign objects [9]. A special protocol for the analysis of infant food for glass has been established by FDA to deal with this highly sensitive issue [10]. III. HAZARD ANALYSIS AND CRITICAL CONTROL POINTS A. Deﬁnition Hazard analysis and critical control points (HACCP) is a preventive system of hazard control that is designed to identify hazards, establish controls, and monitor the controls. Hazards can be harmful microorganisms, toxic chemical contaminants, or physically hazardous foreign objects [11]. The FDA requires formal written HACCP plans for members of the seafood industry. The FDA-mandated seafood HACCP plans [12] must follow the seven principles of HACCP, as listed in Table 1. Recently, the FDA proposed a rule that would require similar HACCP plans for establishments that manufacture or import fruit juice [13]. B. Application The ﬁrst HACCP principle requires an establishment to conduct a hazard analysis to identify any potential hazards, including physical hazards, and to identify preventive measures [14]. Table 2 is an example of the application of the ﬁrst HACCP principle to the identiﬁcation of potential physical hazards. The HACCP planners use aids such as Table 2 to identify which potential hazards are reasonably likely to occur in their manufacturing © 2003 by Marcel Dekker, Inc.

Table 1 National Advisory Committee on Microbiological Criteria for Foods’ Seven Principles of Seafood HACCP 1. 2. 3. 4. 5. 6. 7.

Conduct hazard analysis and identify preventive measures. Identify critical control points. Establish critical limits. Monitor each critical control point. Establish corrective action to be taken when a critical limit deviation occurs. Establish a recordkeeping system. Establish veriﬁcation procedures.

Source: Ref. 10.

Table 2 Examples of Potential HACCP Physical Hazards from Foreign Objects in Food Foreign objects

Potential hazard

Bone (sliver/chip) Burr Button Coin Glass Hand tool Hard plastic

Trauma Trauma/dental Dental Dental Trauma Dental Trauma

Hard shell Hook Insect

Trauma/dental Trauma Trauma

Insulation Jewelry Key Lead weight/shot Loose solder/weld Machinery part Metal shaving Metal sliver Nail Puncture vine Stainless steel Staple Stone Thorn Thumb tack Wire

Trauma Trauma/dental Dental Dental Dental Dental Trauma Trauma Trauma Trauma Dental Trauma Dental Trauma/dental Trauma Trauma

Wood splinter

Trauma

Source: Ref. 4.

© 2003 by Marcel Dekker, Inc.

Possible source Processing (hard/sharp pieces) Raw materials Personal effects Personal effects Processing (e.g., lights, containers) Maintenance Processing (e.g., tote bin, packaging), personal effects (e.g., false ﬁngernail) Raw materials (crustaceans) Raw materials (ﬁsh hook) Raw materials (e.g., sharp spine), processing (e.g., dermestid setae) Maintenance (e.g., asbestos) Personal effects Personal effects Raw materials Maintenance Processing Maintenance (e.g., plumbing repair) Processing (e.g., container strap) Maintenance Raw materials Processing Personal effects Raw materials Raw materials Personal effects Raw materials (e.g., twist tie), processing (e.g., screen/sieve) Raw materials (e.g., crate), processing (e.g., table, tool handle)

process and to locate the possible sources of likely hazards so that appropriate controls can be designed and implemented. The HACCP planner’s goal is to prevent the hazard from occurring and to have a preplanned corrective action ready in the event that the HACCP control fails. The USDA also requires HACCP systems for many of the ﬁrms regulated by that agency. Although HACCP plans are not required for all segments of the food industry, many food manufacturers and processors recognize the value of a voluntary HACCP system and are applying HACCP principles to their businesses. IV. NONHAZARDOUS FOREIGN OBJECTS A. Filth and Extraneous Material Foreign objects that do not qualify as a physical hazard according to the deﬁnition in Sec. II.A may still be considered to be ﬁlth adulterants, as deﬁned in Section 402(a)(3) of the FD&C Act. Filth adulterants are fully discussed in Chapter 6 of this book. B. Naturally Occurring Components Normally, naturally occurring components of a product (e.g., pits in dates) are not considered hazardous because the consumer is aware of the components. However, if a product’s label indicates that the component has been removed (e.g., pitted dates), then the failure to completely remove the component could be construed as adulteration and evaluated according to the physical hazard deﬁnition in Sec. II.A. C. Defect Action Levels Many nonhazardous, naturally occurring hard objects are considered natural defects, which are to a certain extent unavoidable. The FDA establishes maximum levels for these harmless defects (e.g., pit fragments in pitted dates). The FDA maximum levels are called defect action levels. Defect action levels represent levels of natural, harmless defects that are attainable when a product is produced under current good manufacturing practices (CGMPs). Compliance with DALs does not excuse adulteration resulting from unsanitary conditions [12]. D. Other Considerations The intentional addition of a foreign object to a food is subject to criminal prosecution under the Federal Anti-Tampering Act if the intent is fraud or sabotage [15]. The lead enforcement agency for the Federal Anti-Tampering Act, the Federal Bureau of Investigation, often coordinates with the FDA to investigate incidents of tampering. The FD&C Act, Section 402(d)(1), speciﬁcally prohibits imbedding objects in confectionery products. Even though the intent is not malicious, the law speciﬁcally forbids this type of novelty confection. V.

THE FDA COMPLAINT REPORTING SYSTEM

During a 12-month period (October 1988 to September 1989), Hyman et al. [16] compiled data on 10,923 complaints about food registered with the U.S. Food and Drug Administration. Of these complaints, 25% (2726 cases) involved foreign objects in food or drink, © 2003 by Marcel Dekker, Inc.

and 14% (387 cases) of these involved illness or injury associated with foreign objects ingested in beverages or food. Most of the injuries/illnesses, as might be expected, involved cuts or abrasions in the mouth and throat, damage to teeth or dental prostheses, or gastrointestinal distress. The foreign objects were ranked, ordered from most to least common: glass, slime or scum, metal, plastic, stones/rocks, crystals/capsules, shells/pits, wood, and paper. Foreign object complaints involving injury or illness were associated most often with soft drinks, followed in descending order by baby foods, bakery products, cocoa/ chocolate products, fruits, cereals, vegetables, and seafoods. The study by Hyman et al. revealed that health professionals rarely reported cases if injury or illness was attributed to foreign objects in beverages and foods. Most often (82% of the cases), it was the consumer who registered the complaint. Hyman et al. also note that the FDA Complaint Reporting System is a much underused early warning system that, if properly utilized, could beneﬁt greatly both consumers and producers of foods and beverages in the United States. REFERENCES 1. FDA. Federal Food, Drug, and Cosmetic Act, as Amended February 1998. Rockville, MD: Division of Compliance Policy, Ofﬁce of Enforcement, Food and Drug Administration, 1998, pp. 37–38. 2. FDA. Food Defect Action Levels. Washington, DC: Center for Food Safety and Applied Nutrition, Food and Drug Administration, 1995. 3. AR Olsen. Regulatory action criteria for ﬁlth and other extraneous materials: I. Review of hard or sharp foreign objects as physical hazards in food. Regul Toxicol Pharmacol 28:181– 189, 1998. 4. FDA. Compliance Policy Guides: Section 555.425, Foods—Adulteration Involving Hard or Sharp Foreign Objects. Rockville, MD: Division of Compliance Policy, Ofﬁce of Enforcement, Food and Drug Administration, 2000, pp 326–328. 5. G Rider, CL Wilson. Small parts aspiration, ingestion and choking in small children: ﬁndings of the Small Parts Research Project. Risk Anal 16:321–330, 1996. 6. Consumer Product Safety Commission. Title 16, Code of Federal Regulations, Part 1501, Method for Identifying Toys and Other Articles Intended for Use by Children Under 3 Years of Age, Which Present Choking, Aspiration, or Ingestion Hazards Because of Small Parts. Washington, DC: U.S. Government Printing Ofﬁce, 1997, pp 464–467. 7. JR Rhodeheaver. Inspection Procedures for Foreign Materials. U.S. Department of Agriculture File Code 172-A-1, 1996, pp 1–18. 8. AR Olsen, SA Knight, GC Ziobro (eds.). Macroanalytical Procedures Manual, Revised Edition. FDA Technical Bulletin Number 5. Washington, DC: Food and Drug Administration, 1998. 9. JL Boese, SM Cichowicz. Extraneous materials isolation. In: P Cunniff, ed. Ofﬁcial Methods of Analysis of AOAC International. Arlington, VA: AOAC International, 2000, chap. 16, pp. 1–69. 10. JS Gecan, SM Cichowicz, PM Brickey Jr. Analytical techniques for glass contamination of food: a guide for administrators and analysts. J Food Prot 53:895–899, 1990. 11. National Seafood HACCP Alliance. HACCP: Hazard Analysis and Critical Control Point Training Curriculum, 2nd Ed. Raleigh, NC: North Carolina Sea Grant, North Carolina State University, 1997. 12. FDA. Title 21, Code of Federal Regulations, Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. Washington, DC: U.S. Government Printing Ofﬁce, 2000, pp 208–217.

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13. FDA. Hazard analysis and critical control point (HACCP) procedures for the safe and sanitary processing and importing of juice: ﬁnal rule. Fed Reg 66(13):6137–6202, 2001. 14. FDA. Fish and Fishery Products Hazards and Control Guide, Chapter 20—Metal inclusion. Washington, DC: Center for Food Safety and Applied Nutrition, Food and Drug Administration, 1998. 15. U.S. Department of Justice. Federal Code and Rules, Title 18, Code of Federal Regulations, Chapter 65, Section 1365, Tampering with Consumer Products. St. Paul, MN: West Group, 1997, pp 702–704. 16. FN Hyman, KC Klontz, L Tollefson. Food and Drug Administration surveillance of the role of foreign objects in foodborne injuries. Public Health Reports 108(1):54–59, 1993.

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6 Filth and Extraneous Material in Food MICHAEL L. ZIMMERMAN U.S. Food and Drug Administration, Albuquerque, New Mexico, U.S.A. ALAN R. OLSEN U.S. Food and Drug Administration, Washington, D.C., U.S.A. SHARON L. FRIEDMAN U.S. Food and Drug Administration, Laurel, Maryland, U.S.A.

I.

INTRODUCTION

A. The Federal Food, Drug, and Cosmetic Act The Federal Food, Drug, and Cosmetic Act (FD&C Act) [1] contains three paragraphs that apply to extraneous material in food. The ﬁrst, Section 402(a)(1), states that ‘‘a food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health.’’ The second, Section 402(a)(3), states that ‘‘a food shall be deemed to be adulterated if it consists in whole or in part of any ﬁlthy, putrid, or decomposed substance, or if it is otherwise unﬁt for food.’’ Finally, 402(a)(4) states that ‘‘a food shall be deemed to be adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with ﬁlth, or whereby it may have been rendered injurious to health.’’ B. Deﬁnitions The courts have always deﬁned ﬁlth in its ordinary sense (i.e., the dictionary deﬁnition) rather than giving the term any specialized, technical meaning [2]. The same can be said for extraneous material, that is, things that do not belong in food, such as ﬁlth or any foreign matter in a product as a result of objectionable conditions or practices in production, storage, or distribution of food. Included within the meaning of extraneous material © 2003 by Marcel Dekker, Inc.

(or matter) are ﬁlth (any objectionable matter contributed by animal contamination such as rodent, insect, or bird matter); decomposed material (decayed tissues due to parasitic or nonparasitic causes); and miscellaneous matter such as sand, soil, glass, rust, or other foreign substances (bacteria excluded) [3]. C.

AOAC International

In the course of enforcing the FD&C Act, the Food and Drug Administration (FDA) relies upon ofﬁcial compendia for deﬁnitions and analytical methodology for detecting and categorizing ﬁlth and extraneous material in foods. These methods include ﬂotation and sieving extraction procedures for light and heavy ﬁlth recoveries, both microscopic and macroscopic; visual examination procedures for macroscopic ﬁlth; and chemical techniques for detecting residues of urine and excrement. The reliance upon ofﬁcial compendia is required under Part 2, Section 2.19, ‘‘Methods of Analysis,’’ in Title 21 of the Code of Federal Regulations (21 CFR) [4]. Two ofﬁcial compendia commonly used for ﬁlth and extraneous materials are the AOAC International (formerly known as Association of Ofﬁcial Analytical Chemists) Ofﬁcial Methods of Analysis [3] and the FDA ‘‘Macroanalytical Procedures Manual’’ [5]. II. CATEGORIES OF FILTH AND EXTRANEOUS MATERIAL The science relating to ﬁlth and extraneous material has developed in recent years to the point that scientists now recognize three major categories of ﬁlth and extraneous material. The categories are (1) potentially hazardous, (2) indicators of insanitation, and (3) aesthetic defects [6–8]. These categories focus on the issues of food safety and wholesomeness of foods. The purpose of organizing ﬁlth and extraneous material into these three categories is to provide an objective and uniform framework for evaluating whether or not there are any health risks associated with a particular type of ﬁlth element. This framework is especially important for the development of modern food safety programs that rely upon risk management and/or hazard analysis and critical control point (HACCP) principles to ensure the safety and wholesomeness of the food supply [9]. A.

Potentially Hazardous Extraneous Material

1. Criteria The criteria for categorizing foreign/extraneous material as potentially hazardous include: Clinical evidence of injury from ingestion. Recognized as a hazard by medical or scientiﬁc authorities. Hazard is not removed or neutralized by subsequent process or intended use of the product. 2. Examples of Potentially Hazardous Extraneous Material Hazards from extraneous material include physical hazards such as hard or sharp foreign objects (see Chapter 5) and chemical hazards from allergenic pests such as mites and cockroaches [7]. Table 1 lists examples of potentially hazardous allergenic mites that have caused allergic reactions in people when ingested in mite-infested food [7]. Examples of physical hazards are included in Chapter 5. © 2003 by Marcel Dekker, Inc.

Table 1 Examples of Allergenic Mites that Infest Food Products Species

References

Dermatophagoides farinae Suidasia sp. prob. pontiﬁca Thyreophagus entomophagus Tyrophagus putrescentiae

16, 17, 18 17 18 19

Source: Adapted from Ref. 7.

3. Vectors There is also an indirect health hazard from insects and other pests that are known vectors of foodborne diseases. These disease vectors include certain species of ﬂies, cockroaches, ants, and rodents that are contributing factors to the spread of foodborne pathogens such as pathogenic types of Salmonella, Shigella, and Escherichia coli. Table 2 lists the species of pests that meet the following criteria for categorizing a pest as a vector of foodborne pathogens [10]: Synanthropy (living around human settlements) Endophily (found inside buildings) Communicative behavior (moves back and forth between food and pathogen reservoir) Attracted to food and ﬁlth History of pathogens in wild populations It is important to recognize that the actual hazard is the foodborne pathogen, not the pest that carries the pathogen, and that the effective elimination or neutralization of the pathogen hazard, through subsequent processing or intended use of the product, may render the vector species less dangerous as a contributing factor to the spread of the pathogen (see Sec. III for further discussion of this concept). B. Indicators of Insanitation Regardless of whether a health hazard has been demonstrated, pest activity and/or the presence of foreign matter in food are indications of insanitation. 1. Criteria The basis for categorizing ﬁlth and extraneous material as indicators of insanitation is found in the FDA current good manufacturing practices (21 CFR 110) [11]. The current good manufacturing practices, or food CGMPs, address the need for hygienic personnel practices; adequate maintenance of facilities, production, and process controls; hygienic warehousing and distribution practices; and exclusion of pests. The food CGMPs are used to determine whether or not a food is adulterated within the meaning of Sections 402(a)(3) and/or 402(a)(4) of the FD&C Act [1]. 2. Examples of Indicators of Insanitation Often, the ﬁrst indications of insanitation consist of on-site observations by inspectors or quality control personnel. Examples include observations of potential routes of entry for © 2003 by Marcel Dekker, Inc.

Table 2 Examples of Pests that Are Vectors of Foodborne Pathogens Common name German cockroach Brownbanded cockroach Oriental cockroach American cockroach Pharaoh ant Thief ant Houseﬂy Stable ﬂy Little houseﬂy Latrine ﬂy Cosmopolitan bluebottle ﬂy Holarctic bluebottle ﬂy Oriental latrine ﬂy Secondary screwworm Bluebottle ﬂy Green bottle ﬂy Black blow ﬂy Redtailed ﬂesh ﬂy House mouse Polynesian rat Norway rat Roof rat

Scientiﬁc name Blattella germanica (L.) (Dictyoptera: Blattellidae) Supella longipalpa (Fabricius) (Dictyoptera: Blattellidae) Blatta orientalis L. (Dictyoptera: Blattidae) Periplaneta americana (L.) (Dictyoptera: Blattidae) Monomorium pharaonis (L.) (Hymenoptera: Formicidae) Solenopsis molesta (Say) (Hymenoptera: Formicidae) Musca domestica L. (Diptera: Muscidae) Stomoxys calcitrans (L.) (Diptera: Muscidae) Fannia canicularis (L.) (Diptera: Muscidae) Fannia scalaris (Fabricius) (Diptera: Muscidae) Calliphora vicina Robineau-Desvoidy (Diptera: Calliphoridae) Calliphora vomitoria (L.) (Diptera: Calliphoridae) Chrysomya megacephala (Fabricius) (Diptera: Calliphoridae) Cochliomyia macellaria (Fabricius) (Diptera: Calliphoridae) Cynomyopsis cadaverina Robineau-Desvoidy (Diptera: Calliphoridae) Lucilia (Phaenicia) sericata (Meigen) (Diptera: Calliphoridae) Phormia regina (Meigen) (Diptera: Calliphoridae) Sarcophaga haemorrhoidalis (Falle´n) (Diptera: Sarcophagidae) Mus musculus (Mammalia: Muridae) Rattus exulans (Mammalia: Muridae) Rattus norvegicus (Mammalia: Muridae) Rattus rattus (Mammalia: Muridae)

Source: Adapted from Ref. 10.

pests; potential harborage for pests; poor maintenance of equipment or buildings that may lead to contamination; failure of employees to wear appropriate protective garments in food processing areas to prevent contamination; failure to inspect raw materials for contaminants; and discovery of live pest infestations or other evidence of commensal pest activity (e.g., excreta, gnawing, nests) [12]. The presence of ﬁlth from a commensal pest in a food product is, in and of itself, an indication of insanitation. Identiﬁcation of ﬁlth from insects or other pests in food is mandatory in order to differentiate between pest contaminants that are indicators of insanitation and contaminants that are harmless and unavoidable [13]. The precise identiﬁcation of insects fragments in food, for example, allows access to information about the insect’s biology and distribution, which in turn allows the understanding of the history of the contamination and the etiology or origins of the contaminants [14]. 3. Commensal Pests Within the animal community, there are certain species that are considered commensal pests because of their ability to adapt to manmade environments. Evidence of commensal pest activity in a food-processing or storage facility is a strong indicator of insanitation. These pests are synanthropic, endophilic, and attracted to human food. They tend to ﬂourish under the types of insanitary conditions and neglect associated with poor CGMPs and the spread of foodborne disease. There are over 600 species of commensal pests that could © 2003 by Marcel Dekker, Inc.

infest food and food handling facilities [13]. There are four major categories of commensal pests that may contaminate processed food products [10]. The categories are opportunistic pests, adventive pests, obligatory stored-product pests, and parasitoids/predators of the ﬁrst three categories. 1. Opportunistic pests. Opportunistic pests are synanthropic, endophilic, attracted to human food, and communicative in behavior. Unlike stored-product pests, they are rarely found living in the products they contaminate. Examples of opportunistic pests include commensal ﬂies, cockroaches, ants, rats, and mice. Many opportunistic pests are also carriers of disease. If the circumstances indicate a reasonable likelihood that a particular opportunistic pest could transmit pathogens to humans via the food product, then the pest is categorized as a vector. If, under different circumstances, the situation is such that there is little chance that the same pest could actually transmit viable pathogens to the consumer via the food, then the pest is categorized as an opportunistic pest and indicator of insanitation. Thus, a house ﬂy, for example, could be either a pathogen vector or an indicator of insanitation, depending on the circumstances. 2. Adventive pests. Adventive pests are those that are synanthropic and somewhat endophilic but lack communicative behavior and are not particularly attracted to human food. These include bird, bat, and insect pests that may enter food processing facilities in order to nest, roost, or conduct some other activity not closely concerned with the human food located in the facility. 3. Obligatory pests. Obligatory pests are the typical storage pests. They are synanthropic, endophilic, attracted to human food, and normally live and breed in the food product under storage conditions. Obligatory storage insects are rarely associated with the transmission of foodborne pathogens. 4. Parasitoids. Finally, predators and parasitoids (tiny parasitic wasps in this scenario) associated with the other three categories of commensal pests are also encountered as contaminants because they are attracted to their hosts or prey in or near the food product. C. Aesthetic Defects 1. Criteria Filth that does not meet the criteria for hazardous ﬁlth or for indicators of insanitation is nonetheless objectionable to the consumers and excessive levels of these defects are subject to regulatory action. This includes aesthetic defects, incidental and ﬁeld pests, and microscopic ﬁlth elements that are not derived from vectors or indicators of insanitation. The presence of these types of ﬁlth often indicates inadequate cleaning of raw materials. 2. Examples of Aesthetic Defects Examples of types of ﬁlth and extraneous material that meet the criteria for aesthetic defects include agricultural and incidental pests; residues from agricultural ﬁelds such as sand, grit, and stems; and gross contamination that, although essentially harmless, would still be highly objectionable to the consumer. 3. Defect Action Levels Title 21, Code of Federal Regulations, Section 110.110, allows FDA to establish maximum levels of natural or unavoidable defects in foods for human use that present no health © 2003 by Marcel Dekker, Inc.

hazard [11] (see Chapter 7). These food defect action levels (DALs) are set on the premise that they pose no inherent hazard to health. Poor manufacturing practices may result in FDA enforcement action without regard to defect action levels. Likewise, the mixing or blending of food with a defect at or above the current DAL with another lot of the same or another food is not permitted. That practice renders the food unlawful regardless of the defect level of the ﬁnished food. The FDA set these action levels because it is economically impractical to grow, harvest, or process raw products that are totally free of nonhazardous, naturally occurring defects. Products harmful to the consumer, however, are subject to FDA regulatory action whether or not they exceed the action levels. It is incorrect to assume that because FDA has established DALs for a food commodity, the food manufacturer need only stay just below that level. The defect levels do not represent an average of the defects that occur in any of the products—the averages are actually much lower. The levels represent limits at which FDA will regard the food product adulterated and subject to enforcement action under section 402(a)(3) of the FD&C Act [15]. III. APPLICATION Figure 1 presents a sequential procedure for evaluating various types of ﬁlth and extraneous material using the categories described in Sec. II.A–C. The decisionmaking process described in Fig. 1 is a model that reﬂects the decisionmaking process used by FDA

Figure 1

Flow chart for evaluating hazardous and nonhazardous ﬁlth and extraneous materials (SSOP, sanitation standard operating procedures). (Adapted from Ref. 10.)

© 2003 by Marcel Dekker, Inc.

and other regulatory ofﬁcials to determine the signiﬁcance of adulteration from ﬁlth and extraneous material and to decide on an appropriate course of action [10]. A key feature of the process involves the consideration of whether a potentially hazardous contaminant would be rendered harmless or neutralized by subsequent processing or intended use by the consumer. This process allows triage of incidents of insanitation based on the health hazard urgency of the incidents. For example, an infestation of disease-carrying ﬂies in a processing plant requires immediate corrective action if there is no biocidal barrier to pathogen growth. However, if there is a biocidal processing step downline from the ﬂy infestation (and the ﬂies do not circumvent the biocidal step), then the urgency of that ﬂy infestation is reduced from an immediate hazard of pathogen transmission to an indication of insanitation. Even though the ﬂies belong to a disease-carrying species, if their capacity to actually transmit pathogens is neutralized, then the same ﬂies are considered indicators of insanitation. Indicators of insanitation also require corrective action, albeit not of the same urgency that would be appropriate in the absence of a downline biocidal processing step.

REFERENCES 1. FDA. Federal Food, Drug, and Cosmetic Act, as Amended February 1998. Rockville, MD: Division of Compliance Policy, Ofﬁce of Enforcement, Food and Drug Administration, 1998, pp 37–38. 2. PM Brickey Jr. The Food and Drug Administration and the regulation of food sanitation. In: JR Gorham, ed. Ecology and Management of Food-Industry Pests. Arlington, VA: Association of Ofﬁcial Analytical Chemists, 1991, pp 491–495. 3. JL Boese, SM Cichowicz. Extraneous materials isolation. In: P Cunniff, ed. Ofﬁcial Methods of Analysis of AOAC International. Arlington, VA: AOAC International, 2000, chap. 16, pp 1–69. 4. FDA. Title 21, Code of Federal Regulations, Part 2, Subpart 2.19, Methods of Analysis. Washington, DC: U.S. Government Printing Ofﬁce, 2000, p 16. 5. AR Olsen, SA Knight, GC Ziobro (eds.). Macroanalytical Procedures Manual, Revised Edition. FDA Technical Bulletin No. 5. Washington, DC: Food and Drug Administration, 1998, pp VI–117. 6. AR Olsen. Regulatory action criteria for ﬁlth and other extraneous materials. I. Review of hard or sharp foreign objects as physical hazards in food. Regul Toxicol Pharmacol 28:181– 189, 1998. 7. AR Olsen. Regulatory action criteria for ﬁlth and other extraneous materials. Allergenic mites: an emerging food safety issue. Regul Toxicol Pharmacol 28:190–198, 1998. 8. AR Olsen. Regulatory action criteria for ﬁlth and other extraneous materials. Review of ﬂies and foodborne enteric disease. Regul Toxicol Pharmacol 28:199–211, 1998. 9. AR Olsen. Discussion Paper on Proposed Draft Guidelines for Evaluating Objectionable Matter in Food. Codex Alimentarius Commission CCFH/CX/FH 00/13, 2000, pp 1–6. 10. AR Olsen, JS Gecan, GC Ziobro, JR Bryce. Regulatory action criteria for ﬁlth and other extraneous materials. V. Strategy for evaluating hazardous and nonhazardous ﬁlth. Regul Toxicol Pharmacol 33 (in press), 2001. 11. FDA. Title 21, Code of Federal Regulations, Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. Washington, DC: U.S. Government Printing Ofﬁce, 2000, pp 208–217. 12. ML Zimmerman, SL Friedman. Identiﬁcation of rodent ﬁlth exhibits. J Food Sci 65(8):1391– 1394, 2000. 13. AR Olsen, TH Sidebottom, SA Knight (eds.). Fundamentals of Microanalytical Entomology:

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14. 15. 16. 17.

18.

19.

A Practical Guide to Detecting and Identifying Filth in Foods. Boca Raton, FL: CRC Press, 1996. OL Kurtz, KL Harris. Micro-analytical Entomology for Food Sanitation Control. Washington, DC: Association of Ofﬁcial Agricultural Chemists, 1962. FDA. Food Defect Action Levels. Washington, DC: Center for Food Safety and Applied Nutrition, Food and Drug Administration, 1995. AM Erban, JL Rodriguez, J McCullough, DR Ownby. Anaphylaxis after ingestion of beignets contaminated with Dermatophagoides farinae. J Allergy Clin Immunol 92:846–849, 1993. M Sanchez-Borges, A Capriles-Hulett, E Fernandez-Caldas, R Suarez-Chacon, F Caballero, F Castillo, E Sotillo. Mite-contaminated food as a cause of anaphylaxis. J Allergy Clin Immunol 99:739–743, 1997. C Blanco, J Quiralte, R Castillo, J Delgado, C Arteaga, D Barber, T Carillo. Anaphylaxis after ingestion of wheat ﬂour contaminated with mites. J Allergy Clin Immunol 99:308–313, 1997. T Matsumoto, T Hisano, M Hamaguchi, T Miike. Systemic anaphylaxis after eating storage mite–contaminated food. Int Arch Allergy Immunol 109:197–200, 1996.

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7 Food Defect Action Levels JOHN S. GECAN* U.S. Food and Drug Administration, Washington, D.C., U.S.A.

I.

INTRODUCTION

The sections of the federal Food, Drug, and Cosmetic Act (FD&C Act) [1] that are relevant to regulating ﬁlth, decomposition, and extraneous matter are sections 402(a)(1), (a)(3), and (a)(4). Section 402(a)(1) states that a food is adulterated when it bears or contains any poisonous substance which may render it injurious to health. In the area of ﬁlth and extraneous matter, this section generally applies to direct hazards such as contamination by hard or sharp objects such as glass or metal that might cause injury. Section 402(a)(3) states that a food is adulterated if it consists in whole or in part of a ﬁlthy, putrid, or decomposed substance. This section applies speciﬁcally to contaminants found in the food product. An example might be rodent excreta pellets in wheat. Section 402(a)(4) states that a food is adulterated when it is prepared, packed, or held under insanitary conditions whereby the product may have become contaminated with ﬁlth, or whereby it may have been rendered injurious to health. This section applies to insanitary conditions that are reasonably likely to result in contamination of the products, even if adulteration of the food itself cannot be demonstrated. A good example would be unshielded lighting over a production line which could result in product contamination if a bulb were to shatter. This is a condition that would render the likelihood of contamination [2]. This chapter is intended to provide an overview of the food defect action levels (DALs) [3], with respect to the FD&C Act, from their earliest beginnings to their future

* Retired.

© 2003 by Marcel Dekker, Inc.

role in the Food and Drug Administration’s new enforcement strategy for contamination of foods by animal ﬁlth, decomposition, and extraneous matter. (See Appendix D.) A.

What Do We Mean by Filth?

A layman’s deﬁnition of ﬁlth in food would probably focus on some aspect of the food that would make it so repulsive to look at, to smell, or to taste that the food would not be eaten under normal circumstances. Filth can be a health hazard, but even if no hazard can be shown, its mere presence in a product will render that product adulterated. The following sections describe examples of contaminants from the three major contaminant categories of ﬁlth. 1. Rodent Adulteration Rodent contamination comes in many shapes, sizes, and forms. The most repulsive form of contamination by rodents or other mammals is the presence of a whole or partial animal in a product, such as a rabbit’s foot in frozen green beans or a mangled mouse in a custard pie. Rodents commonly cause damage by gnawing on cardboard cartons containing packaged foods. Sometimes the gnawing penetrates the inner packages, exposing the food. Rodents also leave behind their urine and excreta pellets along with the attached rodent hairs. These partially digested hairs, having passed through the rodent’s gut and having emerged embedded or stuck to the fecal pellets, are frequently found as contaminants of foods. Rodent urine stains on foods indicate rodent visitation to the stored product. 2. Bird Adulteration Evidence of bird activity includes everything from birds roosting above stored products in a warehouse to excreta and feathers on product packaging. The open weave of a burlap bag would permit the liquid excreta components, particularly at the time of deposition, to pass through the weave and contact any food inside the sack. As the excreta dries out and the bag is handled, the particles of the bird droppings will break up and pass through the weave into the product. Birds also contaminate foods with microscopic feather fragments such as barbs and barbules. 3. Insect Adulteration Insects may also occasionally be found in consumer products. These insects can generally be separated into ﬁeld and storage types. The unavoidable aesthetic contaminants of ﬁeld origin fall under the DAL regulatory area, while the avoidable storage contaminants represent a lapse of good manufacturing practice (GMP). Examples of insect contaminants of ﬁeld origin include bruchid weevils (e.g., Acanthoscelides obtectus) on beans, corn earworm (Helicoverpa zea) larvae on an ear of corn, and coffee beans that have been bored by the coffee berry borer (Hypothenemus hampei). Examples of storage contamination include Indianmeal moth (Plodia interpunctella) larvae infesting peanuts, ﬂour beetles (Tribolium spp.) in bread, and cigarette beetles (Lasioderma serricorne) in spices. 4. Mold Adulterants Mold contaminants can generally be separated into two groups, avoidable and unavoidable. Avoidable molds on tomatoes as they arrive from the ﬁeld are generally removed from the lot before they enter the processing line. If some of the rotted tomatoes get into © 2003 by Marcel Dekker, Inc.

the processing line, whether through error or carelessness, this fact can be brought to light by analytical techniques that demonstrate mold particles in ﬁnished products such as catsup. Geotrichum spp., one of the avoidable molds, also known as machinery mold or slime mold, grows on food contact surfaces of processing lines, especially in those environments that are warm and moist, as in fruit and vegetable canning factories. In-process food products passing over contaminated processing lines can dislodge pieces of this mold. Upon analysis, clumps of the Geotrichum mold that had been growing on the food contact surfaces of the processing line can be demonstrated in the ﬁnished product. 5. Adulteration by Extraneous Matter Examples of extraneous material include glass shards, sand and pebbles, pits in pitted olives, and shell fragments in canned clams and oysters. B. What Are Defect Action Levels? Title 21, Part 110.110 of the Code of Federal Regulations [4] allows the Food and Drug Administration (FDA) to establish maximum levels of natural or unavoidable defects in foods for human use that present no health hazard. Defect action levels represent levels of natural or unavoidable defects or contaminants that can be found in a food product produced from acceptable quality raw materials using current processing technologies and sanitation practices. The levels represent limits at which FDA regards food products to be adulterated and subject to regulatory action under Section 402(a)(3) of the FD&C Act. C. Where Did DALs Come From? For purposes of perspective, it is important to understand how ﬁlth, decomposition, and extraneous matter have been regulated up to this point in time. The early regulation of aesthetic ﬁlth relied primarily upon the FDA’s scientiﬁc knowledge and regulatory case precedents that were generally not available to the public. 1. Action Criteria Defect action levels had their origins with the FDA’s ‘‘action criteria’’ for ﬁlth and decomposition defects and contaminants beginning in the early 1900s as ‘‘tolerances,’’ followed by ‘‘ﬁeld legal action guides’’ in the 1950s, ‘‘administrative guidelines’’ in the early 1960s, and ﬁnally the ‘‘compliance policy guides’’ (CPGs) (5) of the late 1960s. 2. Howard Mold Count One of FDA’s earliest action criteria was established in 1911 as a tolerance for mold in tomato pulp. That action limit, called a tolerance, was based on the Howard mold count method (a count of mold mycelial fragments observed under a microscope) [6] that estimated the amount of moldy raw tomatoes present in the ﬁnished product pulp. 3. Conﬁdential Action Levels Over the years since the ﬁrst established mold tolerance, as analytical methods became available, other action levels have been developed for other defects, such as insect and rodent contaminants. These action levels went through several name changes but remained essentially the same action criteria. Prior to 1972, all the action criteria, regardless of what © 2003 by Marcel Dekker, Inc.

Table 1 Published Defect Action Level Contamination Proﬁle Studies Product Chocolate, unsweetened Cranberry sauce, whole and jellied Wheat Walnuts Pecans Brazil nuts Tomato juice Tomato paste Tomato puree Tomato sauce Tomato soup Apricot nectar Peach nectar Pear nectar Apricot puree Peach puree Pear puree Wheat ﬂour Oregano, ground and unground Cinnamon, ground Nutmeg, ground Macaroni Noodles Marjoram, ground and unground Sage, ground and unground Thyme, ground and unground Allspice, ground Black pepper, ground Paprika, ground Coffee beans, green Crabmeat, canned Sardines, canned Tuna, canned Creecy greens, canned Collard greens, canned Kale greens, canned Mustard greens, canned Turnip greens, canned Shrimp, fresh and frozen

Contaminant

Reference

Insect, bird, rodent Mold Insect, rodent Insect, mold, decomposition

7 8 9 10

Mold, rot, ﬂy eggs, maggots

11

Mold

12

Insect, rodent Insect, rodent, bird

13 14

Insect, rodent

15

Insect, rodent, bird

16

Insect, mold, mammalian excreta Insect, rodent, bird

17 18

Insect

19

Insect, rodent, Listeria spp., Salmonella spp., decomposition

20

they were called, were generally regarded as conﬁdential and were available only to a select group of FDA regulatory ofﬁcials. 4. Action Levels Made Public In 1972, FDA Commissioner Charles Edwards made the Agency’s action criteria for ﬁlth, decomposition, and extraneous matter available to both consumers and manufacturers. © 2003 by Marcel Dekker, Inc.

The commissioner directed that the action criteria, now known as CPGs, should be released to the public as ‘‘defect action levels,’’ an abbreviated, condensed version of the CPGs. When work was initiated to comply with the commissioner’s directive, the existing action levels were extracted from the CPGs. Some remain the same today, while others have been updated to reﬂect improved agricultural and manufacturing technologies. Additionally, new action levels were established for a number of foods based on identiﬁed needs. D. About the DAL Booklet The Food Defect Action Levels booklet is available in hard copy from the Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, or on the Internet at http://ﬁrst.fda.gov/infosr.htm. The most recent issuance is May 1998. The booklet consists of a preface, glossary, and a listing of action levels by product. 1. The preface. The preface cites the Code of Federal Regulations section that authorizes the FDA to establish DALs, the signiﬁcance of contaminants resulting from a failure to adhere to GMP, a brief discussion of why DALs exist, what the levels mean, and the FDA’s regulatory position relative to products lacking DALs. 2. The glossary. The glossary deﬁnes the terminology used in the action levels section of the booklet. 3. The action levels section. The action levels section is an alphabetical listing of defect action levels, with each DAL linked to a speciﬁc analytical method used in the database development for that product. It is incumbent upon the users of this booklet to be aware that different analytical methods may yield different analytical results for a particular product and that the FDA uses the cited analytical method to determine contamination proﬁles for a product lot in order to apply the published action levels. The DAL booklet also provides ‘‘defect source’’ and ‘‘defect signiﬁcance’’ information for each product listed. After an existing DAL was updated or a new DAL established and published in the DAL booklet, the details of the update or establishment studies were published as a series of research notes detailing the contamination proﬁles of signiﬁcant contaminants for each product studied. All of the contamination proﬁle studies were published, as research notes in the Journal of Food Protection from 1978–1994. Table 1 lists the products and contaminants for which contamination proﬁle studies were published.

II. SIGNIFICANCE OF DEFECT ACTION LEVELS A. About DAL Contaminants The DALs are set because it is economically impractical to grow, harvest, or process raw agricultural products that are totally free of nonhazardous, naturally occurring, unavoidable defects. It is therefore incumbent upon the food processing industry to process the best quality raw materials under the best sanitary conditions using current processing technologies in order to produce the high quality products that U.S. consumers have learned to expect. © 2003 by Marcel Dekker, Inc.

Industry should never strive to just meet the DAL by manipulating the manufacturing process or by the illegal act of blending. The mixing of high quality products with poor quality products just to meet the DAL is not only unethical, but is illegal under current FDA regulations [21]. This practice renders the blended food product unlawful, regardless of the level of defects or contaminants in the ﬁnished product. Poor manufacturing practices may cause a food product to contain levels of ﬁlth, decomposition, and extraneous matter contaminants that do not exceed the published DAL; however, these products are still subject to enforcement action under current FDA regulations because the insanitary processing conditions that contributed to the contamination were avoidable. Likewise, a food product containing ﬁlth, decomposition, or extraneous matter contaminants determined to be hazardous to consumers [22], regardless of levels or sources of contamination, is subject to regulatory action within the meaning of 402(a)(1), in that the food bears or contains a deleterious substance which may render it injurious to health [1]. B.

Impacts on Users

Defect action levels provide food regulatory agencies with the action limits they need to distinguish between legal and illegal food products as deﬁned under Section 402(a)(3) of the FD&C Act. The DALs ensure uniformity of regulatory actions between food regulatory agencies at local, state, and federal levels, and also internationally. Defect action levels provide food processors with the action criteria, used by regulatory authorities, that deﬁne the minimal acceptable quality achievable when raw agricultural materials are handled and processed under good manufacturing practice. DALs allow in-plant quality control analyses to distinguish between acceptable and unacceptable ﬁnished products. III. SO YOU NEED A DAL Don’t even consider asking the FDA to develop a DAL for a particular product. The agency’s DAL development program operated at full capacity for at least a dozen years after the FDA commissioner mandated the public release and updating of the DALs in 1972. After more than a decade of data development studies to update existing and establish new DALs, the commissioner’s mandated goal was considered to have been achieved. Because of the high cost of sample collections and analyses associated with the development of databases necessary to update or establish DALs, and because of the recent reprioritization of DALs for aesthetic ﬁlth, decomposition, and extraneous matter, the DAL development program has been placed in abeyance. A.

Should I Develop My Own DAL?

One solution to the absence of a DAL is for you to undertake the development of a DAL for your product. Before you decide to proceed with this endeavor, you must consider the magnitude and cost of the effort required to accomplish the job. Once you have identiﬁed the appropriate defects or contaminants of a speciﬁc product, a validated method of analysis is essential. If a method exists, you are ready to consider the sampling requirements. If not, the method development research and validation process must be undertaken. This phase of the study can require several years or more of effort, © 2003 by Marcel Dekker, Inc.

depending upon the difﬁculty of the methods research and the outcome of the interlaboratory collaborative study (a system used to determine the reliability and accuracy of any new method). With the method phase completed, a sampling plan that considers geographic, seasonal, and environmental factors affecting contaminants or defects must be developed. These considerations will determine the collection sites—retail market place, ports of entry, or both. Will the sampling be conducted in a single year or multiple years in order to ensure consideration of the seasonal and environmental ﬂuctuations of the occurrence of the contaminants? Sample collection is no small undertaking. A minimum of 1500 production lots is required for the establishment of a new DAL. Who will carry out the collection and who will pay for all these samples? With a validated method and representative product samples in hand, one must ﬁnd a qualiﬁed laboratory to perform the analyses. My experience in this phase of the development process has shown that many laboratories are ready and willing to reap the ﬁnancial beneﬁts associated with the analysis of 1500 samples, but ﬁnding a laboratory that is technically qualiﬁed to perform the sample extraction and quantify the selected contaminants is problematic. One cannot assume that all laboratory personnel are qualiﬁed to perform analyses for ﬁlth, decomposition, or extraneous matter, even if they claim to be. A careful examination of both company and analyst qualiﬁcations, along with a judiciously monitored analytical audit program, is essential to getting the results you will be paying for. Once valid product contamination proﬁles have been obtained, it would be advisable to contact the FDA analysts or other knowledgeable individuals to obtain guidance with the data analysis and the action level setting process. When all is said and done, the development of a DAL for a single product can require ﬁve years or more at a minimum cost of $200,000. B. Use Existing Action Levels Considering the foregoing discussion of DAL development, a more appealing alternative is to use an existing DAL for a similar product, if one exists. To do this, one must still consider the applicability issues such as identifying appropriate contaminants and the geographical and seasonal inﬂuences on their occurrence in the subject product. There is no cheap, easy answer. IV. THE FUTURE OF DEFECT ACTION LEVELS In keeping with a pattern set during the past century, the action criteria for ﬁlth, decomposition, and extraneous matter have undergone still another change. This current change, while keeping the DALs intact conceptually, places the DALs within the context of the recently revised enforcement strategy for ﬁlth, decomposition, and extraneous matter. A. The Revised Strategy The revised enforcement strategy was a joint effort of the FDA’s Ofﬁce of Regulatory Affairs and the Center for Food Safety and Applied Nutrition (CFSAN). In June 1999, the strategy was presented to the FDA’s Food Advisory Committee [23]. This is a technical and scientiﬁc committee that advises the agency on emerging food safety, food science, and nutrition issues. The committee consists of 18 standing members with expertise in the physical and life sciences, food science, risk assessment, and other relevant scientiﬁc © 2003 by Marcel Dekker, Inc.

and technical disciplines. Most members are drawn from academia, government, and professional societies, with some technically qualiﬁed members also representing consumer and industry interests. The Food Advisory Committee unanimously endorsed the revised enforcement strategy [24]. The strategy has its foundations in published scientiﬁc literature [25–28] that deﬁnes scientiﬁc criteria for the objective evaluation of health hazards, GMP violations, and aesthetic contaminants associated with ﬁlth, decomposition, and foreign matter in foods. The scientiﬁc criteria are components of a transparent process (readily accessible to all interested persons) for reviewing regulatory actions and making enforcement decisions based on end-product analyses of ﬁnished product samples. The strategy is suitable for evaluating analytical results from end-product surveillance sampling by FDA and from samples analyzed by private testing laboratories and food processors quality control laboratories. The criteria are organized into three prioritized categories associated with ﬁlth, decomposition, and extraneous matter contaminants: (1) health hazards, (2) good manufacturing practice violations, and (3) aesthetic contaminants (as identiﬁed in the DAL booklet). B.

DALs and the Revised Strategy

Incorporation of the DALs into the FDA’s revised enforcement strategy has effectively changed the regulatory signiﬁcance of these action criteria. This current change has appropriately placed the DALs for aesthetic ﬁlth, decomposition, and extraneous matter in the proper perspective with the other two identiﬁed contaminant categories of the new enforcement strategy—health hazards and GMP violations. The evaluation process for analytical ﬁndings starts with the ﬁrst priority action criteria, that is, for health hazards. If none is found, the evaluation next considers the second priority action criteria, for GMP violations. Again, if evidence of poor manufacturing practice is not found, the evaluation proceeds to the ﬁnal stage where analytical results are compared with relevant CPGs or other precedents regarding acceptable levels of harmless or aesthetic ﬁlth, decomposition, and extraneous matter, i.e., the DALs. It must be emphasized that while DALs have been reprioritized to a lower regulatory enforcement category, the FDA continues to take regulatory actions against aesthetic (DAL) ﬁlth as well as sanitation-related GMP violations and food safety issues involving ﬁlth and extraneous matter (e.g., hard foreign objects, toxic mushroom contaminants, etc.). Fiscal year 2000 ﬁlth case referral ﬁgures provided by FDA show 450 actions for aesthetic (DAL) ﬁlth, 20 actions for sanitation-related GMP violations, and ﬁve ﬁlth and extraneous matter food safety actions. This revised enforcement strategy provides broad-ranging beneﬁts. The FDA will operate more efﬁciently, with reduced case referrals from the ﬁeld to headquarters. The agency receives hundreds of case referrals every year from FDA ﬁeld ofﬁces for subject matter review, with generally a one- to ﬁve-day turnaround time. Once the enforcement strategy is formalized and in the hands of the FDA ﬁeld compliance ofﬁces, many of those decisions will be made on-site in the district ofﬁces and will not require subject matter expert review at headquarters. To consumers, it provides increased protection from genuine foodborne hazards associated with ﬁlth, decomposition, and extraneous matter, while providing a reasonable level of emphasis on the purely aesthetic contaminants. © 2003 by Marcel Dekker, Inc.

To the regulated industry, it provides a level playing ﬁeld of action criteria for both imported and domestic products and predicted cost savings through faster regulatory review turnaround, reduced storage time for seized or detained goods, and fewer reconditionings. Everyone will beneﬁt from clearly deﬁned action criteria that will result in uniform regulatory decisions worldwide. Transparency of both the action criteria and the science base will enable industry, both here and abroad, to fully understand FDA’s approach to regulating ﬁlth, decomposition, and foreign matter. While maintaining the sanitation safeguards of the federal FD&C Act, the revised strategy preserves the wholesomeness role of the defect action levels in the proper perspective with regard to GMP violations and the genuine food safety hazards from ﬁlth, decomposition, and extraneous matter. REFERENCES 1. FDA. Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration. Washington, DC: U.S. Department of Health and Human Services, 1984. 2. PM Brickey Jr. Concepts of food protection. In: JR Gorham, ed. Principles of Food Analysis for Filth, Decomposition, and Foreign Matter, 2nd Ed. Washington, DC: Food and Drug Administration, 1981, pp 3–5. 3. Industry Activities Staff. The Food Defect Action Levels. Washington, DC: Food and Drug Administration, 1998. 4. FDA. Title 21, Code of Federal Regulations, Part 110.110, Natural or Unavoidable Defects in Food for Human Use that Present no Health Hazard. Washington, DC: U.S. Government Printing Ofﬁce, 1988, pp 222–223. 5. DL Michels, A Schroff, eds. FDA Compliance Policy Guides. Rockville, MD: Food and Drug Administration, 1996. 6. JL Boese, SM Cichowicz. Extraneous materials isolation. In: P Cunniff, ed. Ofﬁcial Methods of Analysis of AOAC International. Arlington, VA: AOAC International, 2000, pp 1–69. 7. JS Gecan, JE Kvenberg, JC Atkinson. Microanalytical quality of unsweetened chocolate. J Food Prot 41:696–698, 1978. 8. JS Gecan, AE Schulze, SM Cichowicz, JC Atkinson. Mold in jellied and whole-berry styles of cranberry sauce. J Food Prot 42:328–329, 1979. 9. JS Gecan, JJ Thrasher, WV Eisenberg, PM Brickey. Rodent excreta contamination and insect damage of wheat. J Food Prot 43:203–204, 1980. 10. JS Gecan, PM Brickey, JC Atkinson. Defects of inshell walnuts, pecans and Brazil nuts. J Food Prot 45:547–548, 1982. 11. SM Cichowicz, JS Gecan, JC Atkinson, JE Kvenberg. Microanalytical quality of tomato products: juice, paste, puree, sauce and soup. J Food Prot 45:627–631, 1982. 12. R Bandler, JS Gecan, JC Atkinson. Mold in fruit nectars and infant fruit purees. J Food Prot 45:634–635, 1982. 13. JS Gecan, JC Atkinson. Microanalytical quality of wheat ﬂour. J Food Prot 46:582–584, 1983. 14. JS Gecan, R Bandler, LE Glaze, JC Atkinson. Microanalytical quality of ground and unground oregano, ground cinnamon and ground nutmeg. J Food Prot 46:387–390, 1983. 15. JS Gecan, JC Atkinson. Microanalytical quality of macaroni and noodles. J Food Prot 48: 400–402, 1985. 16. JS Gecan, R Bandler, LE Glaze, JC Atkinson. Microanalytical quality of ground and unground marjoram, sage and thyme, ground allspice, black pepper and paprika. J Food Prot 49:216– 221, 1986. 17. JS Gecan, R Bandler, JC Atkinson. Microanalytical quality of imported green coffee beans. J Food Prot 51:569–570, 1988.

© 2003 by Marcel Dekker, Inc.

18. JS Gecan, R Bandler, JC Atkinson. Microanalytical quality of canned crabmeat, sardines, and tuna. J Food Prot 51:979–981, 1988. 19. JS Gecan, R Bandler. Microanalytical quality of canned collard, creecy, kale, mustard, and turnip greens. J Food Prot 53:511–512, 1990. 20. JS Gecan, R Bandler, WF Staruszkiewicz. Fresh and frozen shrimp: a proﬁle of ﬁlth, microbiological contamination, and decomposition. J Food Prot 57:154–158, 1994. 21. FDA. Title 21, Code of Federal Regulations, Part 110.110(d) Natural or Unavoidable Defects in Food for Human Use that Present no Health Hazard. Washington, DC: U.S. Government Printing Ofﬁce, 1998, p 223. 22. FDA. Foods—adulteration involving hard or sharp foreign objects. FDA Compliance Policy Guide. Fed Reg 64(62), 15774–15775, 1999. 23. FDA. Food Advisory Committee: notice of meeting. Fed Reg 64(110), 31005–31006, 1999. 24. JS Gecan, AR Olsen. Enforcement of Filth and Extraneous Materials. Transcript of FDA Food Advisory Committee Meeting, Arlington, VA, 1999. Available at http:/ /www.fda.gov/ohrms/ dockets/ac/cfsan99.htm (click on 3524t1.rtf). 25. AR Olsen. Regulatory action criteria for ﬁlth and other extraneous materials. I. Review of hard or sharp foreign objects as physical hazards in food. Regul Toxicol Pharmacol 28:181– 189, 1998. 26. AR Olsen. Regulatory action criteria for ﬁlth and other extraneous materials. II. Allergenic mites: an emerging food safety issue. Regul Toxicol Pharmacol 28:190–198, 1998. 27. AR Olsen. Regulatory action criteria for ﬁlth and other extraneous materials. III. Review of ﬂies and foodborne enteric disease. Regul Toxicol Pharmacol 28:199–211, 1998. 28. AR Olsen, JS Gecan, GC Ziobro, JR Bryce. Regulatory action criteria for ﬁlth and other extraneous materials. IV. Regulatory action criteria proﬁles and regulatory action categories. Regul Toxicol Pharmacol 33:362–392, 2001.

© 2003 by Marcel Dekker, Inc.

8 Analysis of Drug Residues in Food SHERRI B. TURNIPSEED U.S. Food and Drug Administration, Denver, Colorado, U.S.A.

I.

INTRODUCTION

The use of antibiotics or other medications is common in modern agriculture because animals are held together in dense populations where the potential for disease outbreak is high. Drugs can be used therapeutically, to cure existing disease, or prophylatically, to minimize the potential for disease threat across a population. Often, however, they are used subtherapeutically as growth promotants to increase feed conversion. The possibility of drug residues remaining in the edible product and the potential human health problems associated with exposure to these residues is a concern because of the widespread drug use in food animals. The actual public health signiﬁcance of drug use in animal agriculture and of their residues in food of animal origin is an area of much debate. Recently the National Research Council convened a group to evaluate the beneﬁts and risks of using drugs in the animal food industry (National Research Council, 1999). They identiﬁed antimicrobial resistance of disease-causing bacteria as the most serious risk associated with the continued use of drugs in food animals. Animals fed low (subtherapeutic) levels of antibiotics may develop bacterial infections that evolve to be impervious to these drugs. Humans may be exposed to these bacterial populations in the environment or during preparation or consumption of food. A task force consisting of several U.S. government agencies has formulated a public health plan to combat antimicrobial resistance, including ways to limit the spread of drug resistance due to agricultural applications (Center for Disease Control, 2001). In addition, some animal drugs may cause an immediate adverse reaction, such as allergic response, in susceptible human populations. Therefore, it is important to regulate the improper use of animal drugs by monitoring animal tissues or the resulting food products for drug residues. © 2003 by Marcel Dekker, Inc.

The occurrence of drug residues is possible in any food of animal origin. This includes, but is not limited to, tissue (muscle, liver, kidney) or fat from bovine, swine, poultry, ﬁsh, shrimp, or minor species (such as ratites, rabbits) in addition to animal products such as milk, eggs, and honey. Because this is such a diverse list, the procedures for food processing, and therefore the sanitation guidelines as well as the regulations covering these commodities, are also quite varied. The governmental responsibility for reducing the incidence of animal drug residues in the nation’s food supply is primarily shared between the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA). The FDA regulates animal drug residues in milk, eggs, and aquaculture products. The USDA is responsible for monitoring meat and poultry products for animal drug residues. The Food Safety Inspection Service (FSIS) of the USDA conducts the National Residue Program (NRP) to prevent animals containing violative amounts of drug residues from being marketed (Food Safety Inspection Service, 1998). The FDA is also responsible for approving new animal drugs, setting tolerances, and conducting enforcement actions as a result of any FSIS ﬁndings. In many cases the introduction of illegal residues occurs at the original producer or farmer and not at the food processing establishment. In fact the most common causes for the presence of illegal residues include not following proper withdrawal times, administration of improper dosage, etc. However, a recent review illustrates how contamination can also be a cause of illegal animal drug residues (Kennedy et al., 2000). One possible source of contamination includes mixing of nonmedicated feed with medicated feed during manufacturing, compounding, or transporting. In addition, these authors provide examples of wild ﬁsh or other aquatic species harvested near aquaculture pens being contaminated with drug residues from that facility. Another study cited in this review illustrates how pigs held in the same housing structure as a previous population that had been given sulfamethazine were found to be positive for this residue by immunoanalysis of their kidney tissue (McCaughey et al., 1990). All of these possible sources of drug residue contamination relate directly to food/feed sanitation procedures. Even if the causes of illegal drug residues are more likely to originate with the food producer, the introduction of hazard analysis critical control point (HACCP) programs holds food processing plants responsible for minimizing this source of contamination. The use of HAACP as a tool to ensure food safety extends to residue monitoring. Under the HAACP system food processing plants must have systems in place to prevent hazards in their products. These hazards include not only pathogenic organisms and physical hazards, but also chemical residues such as illegal drugs or pesticides. The rule indicates that the industry must evaluate signiﬁcant residue hazards and develop a HAACP plan for controlling residues. An example of a HAACP plan designed to minimize the risk of drug residues at the producer level is the Milk and Dairy Beef Residue Prevention Protocol (Boekman and Carlson, 2000). Aspects of a HAACP plan for a food processing plant designed to reduce the risk of illegal drug residues might include avoiding buying animals from problem producers and implementing live animal tracking and residue testing (Dey, 2001). Monitoring the food supply for residues is important because of the potential health risk from exposure to some animal drugs. However, the low levels and complex matrices involved can make residue monitoring a real analytical challenge. Several broad types of analytical methods for drug residues in food can be described, including screening, determinative, and conﬁrmatory procedures. These all play a role in monitoring the food supply for chemical residues due to improper use of animal drugs. © 2003 by Marcel Dekker, Inc.

II. ANALYTICAL METHODS FOR DRUG RESIDUES A. Screening Methods Screening methods are designed to be rapid, easy-to-use tests which provide a positive or negative response for a drug at a given concentration level in a matrix. Samples taken at food processing plants are often analyzed initially using a screening test to determine if there may be a problem with drug residues. Traditionally, microbial inhibition tests (MITs) have been used to screen large numbers of samples for antimicrobials, and these tests are still widely used. All MITs are based on the inhibition of bacterial growth by antibacterial residues present in a matrix that results in zones of inhibition on bacterial plates. These tests are relatively simple to use and detect many classes of antibacterial compounds. Selective sensitivity for speciﬁc classes of antibacterials can be obtained by changes in the culture medium, indicator bacteria, or pH. However, these methods often lack the speciﬁcity and sensitivity required for residue detection at maximum residue limits. They may be affected by nonspeciﬁc inhibitors and do not detect microbiologically inactive metabolites. In addition, they often require a 20–24 hr incubation period. Microbial inhibition tests that have been used by the FSIS for screening red meat and poultry tissues for antibacterial residues include the Swab Test On Premises (STOP) and the Calf Antibiotic and Sulfa Test (CAST) (Sundlof, 1989). The Fast Antibiotic Screen Test (FAST) is a test used by FSIS that provides results within 6 hr. There are several other MITs used globally, including the New Dutch Kidney Test, the German Three Plate Assay, the European Four Plate Test, and the Charm Farm Test. Although MITs can be very useful, there are some inherent problems with these tests, including the FAST test. Imprecision occurs as a result of zone of inhibition size differences between replicate plates. Zone size may vary as a result of differences in agar layer thickness, agar quality, uneven seeding of bacterial spores on the agar surface, or incubator temperature variation (Brady and Katz, 1987). Additionally, bacteriostatic drugs such as sulfonamides may result in a diffuse zone, while bactericidal drugs provide a sharply deﬁned zone of inhibition, and this may complicate the interpretation. In fact, studies indicate that the sensitivity to the FAST test for different classes of drugs can vary widely (Korsrud et al., 1998). In addition to MITs, new rapid test kits, generally based on bacterial cell receptor or enzyme immunoassay, are being used to screen samples for speciﬁc drugs. The Charm II test is a proprietary competitive microbial receptor binding assay that can detect residues of seven classes of antibiotics. Although this test can detect a number of drugs within a class, the relative sensitivity of the test to individual drugs varies. It is commonly used for monitoring antibiotics in milk, but has also been tested for use in bovine muscle and kidney samples (Korsrud et al., 1994). Immunoassays are widely used on dairy farms and processing plants to screen milk samples for veterinary drug residues. With appropriate extraction methodology many of these assays may also be used for residue analysis of food animal tissues. Recent examples of the use of immunoassays in meat analysis include the analysis of aminoglycosides in porcine kidney (Haasnoot et al., 1999) and tetracyclines in pork and chicken meat (De Wasch et al., 1998). These rapid tests are well suited for in-plant use due to the limited amount of sample manipulation, simple analytical equipment and procedures required, and the relatively fast analysis time. © 2003 by Marcel Dekker, Inc.

B.

Determinative Methods

These screening tests, however, are not always accurate at or below the test threshold. They are often class, not compound, speciﬁc, and may or may not give quantitative information. Therefore, additional analytical tests may be needed to determine if a sample is actually violative for an animal drug residue. Determinative methods are designed to separate, quantitate, and perhaps provide some qualitative information on the analyte of interest. These tests may require more specialized laboratory equipment and experienced personnel to perform than the screening tests discussed previously. A determinative method involves several stages including sample preparation, extraction of the analyte from the food matrix, separation of the drug residue from any remaining matrix components, and detecting (measuring) the amount of residue present. Sample preparation, isolation, and cleanup are major rate-limiting factors in sample analysis. The classical approach to isolation of drugs from tissues involves tissue homogenization followed by liquid–liquid partitioning of the homogenate, with or without additional cleanup or concentration steps. These methods may provide adequate separation of the drug from the matrix but are often expensive in terms of time, labor, material use, and organic solvent disposal costs. Such approaches also tend to be highly nonspeciﬁc in their isolation of the target drug(s). Recent advances in the ﬁeld of residue analysis offer several promising techniques as possible solutions to the problems caused by outmoded and complex analytical methods. Three techniques—solid-phase extraction (SPE), matrix solid-phase dispersion (MSPD), and immunoafﬁnity—are receiving particular attention because they have the potential to greatly reduce analytical costs and reduce analysis-generated waste and pollution. The SPE process is a type of chromatographic separation designed to isolate the analyte of interest from the rest of the food matrix. Before SPE can be used with solid tissue (e.g., muscle and liver), a separate homogenization step and often additional steps are required. The most common use of SPE is to develop conditions whereby the analyte adheres to the solid-phase material while the other components are washed through, then the solvent system is changed to elute the analyte separately. Because selection of the SPE column depends on the matrix and on the particular compound of interest, a wide range of solidphase extraction columns of differing polarities have been used for drug extraction from tissue and include silica, alumina, C 18 , NH 2 , and ion exchange resins. Matrix solid-phase dispersion (MSPD) is a variation of the SPE isolation technique. In general terms, MSPD involves blending a tissue sample (0.1–1.0 g) with lipophilic polymer-derivatized silica particles, which simultaneously disrupts and disperses the sample. The resulting slurry is then packed as a ‘‘column’’ which can be eluted with appropriate solvent to give an extract containing the residue of interest. Matrix solid-phase dispersion has been used in the analysis of furazolidone (Long et al. 1990), penicillins (McGrane et al., 1998), and sulfamethazine (Shearan et al., 1994) in swine tissue. This technique has also been used to analyze milk samples for chemical residues (Schenck and Wagner, 1995). The simplest methods of extraction, however, require minimal or no sample manipulation. These are the methods that extract the drug directly from the sample matrix by means of speciﬁc or selective antibodies or receptors. Immunoafﬁnity isolation techniques can be used for sample cleanup. Recent examples where immunoafﬁnity techniques have been used in animal drug residue analysis include the determination of 19-nortestosterone © 2003 by Marcel Dekker, Inc.

and trenbolone in animal tissue (Stubbings et al., 1998) and avermectins in cattle meat (Li and Qian, 1996). Once a drug residue has been extracted from the food matrix, the amount of residue can be measured using the physical characteristics of the molecule after separation from any remaining food components. Many of the drugs used in animal agriculture can be separated from any remaining food matrix using liquid chromatography (LC). In LC, separation occurs when a compound is isolated from a liquid sample based on its relative solubility in the liquid mobile phase compared to its solubility in a solid support-bound liquid stationary phase or its afﬁnity to a solid support stationary phase. Reverse-phase LC chromatography columns generally consist of a liquid phase (C 18 , C 8 , phenyl, etc.) covalently bound to a spherical (particle size 3–10 µm) silica support. The degree of free silanol groups remaining unbound can greatly affect the selectivity of the column for any given analyte. There is a great variety of LC columns commercially available based on principles of polymer chemistry, chiral selection, ion exchange, and size exclusion, as well as the traditional reverse-phase chemistry. Ideally the compound of interest can be eluted from the chromatographic column isolated from any other material and then introduced into a detector to measure the amount of compound present. For LC the most common detector is a UV/VIS spectrophotometer using a variable wavelength or diode array. Liquid chromatographs using ﬂuorescence, chemiluminescence, or postcolumn reaction detectors are also available and have been successfully used to determine drug residues in animal tissue. Gas chromatography (GC), in which separation is based on the relative partitioning of an analyte into a liquid coated onto a fused silica capillary as it travels through the column in the gas phase, can also be used to analyze drug residues in food matrices. GC is very suitable to volatile analytes such as organophosphates. Many animal drugs have a large molecular weight and are relatively nonvolatile and thermally labile. To overcome these characteristics, chemical derivatization is generally required to obtain sufﬁcient volatility and stability for GC analysis. Detection for GC is generally done using ﬂame ionization or electron capture techniques. More selective detectors for nitrogen-, phosphorus- and sulfur-containing compounds are also available, and mass spectrometry (MS) detection is commonly used as a detector for GC. Several reviews have been written on the determinative methods in use today (Oka et al., 1995; Turnipseed and Long, 1998). In addition, the European Union has established a database of veterinary drug determinative methods (Van Eeckhout et al., 1998). Section III of this chapter lists the common types of animal drugs that might be found in food, typical extraction and analytical parameters, as well as some references for more recent speciﬁc procedures or reviews.

C. Conﬁrmatory Methods Conﬁrmatory methods are meant to provide absolute identiﬁcation of the drug residue in question. Because of its sensitivity and speciﬁcity, mass spectrometry is the preferred method for conﬁrmation. Guidelines as to what should constitute a positive identiﬁcation with mass spectral data have been discussed (Sphon, 1978; FDA, 2001). In most cases, conﬁrmation is achieved using an instrument that interfaces the MS with a chromatograph (GC or LC). There are many examples in the reference section of this chapter of methods © 2003 by Marcel Dekker, Inc.

that contain not only determinative procedures, but also give information on qualitative conﬁrmatory analysis. III. SUMMARY OF ANALYTICAL METHODS FOR DRUG RESIDUES IN FOOD A.

Sulfonamides Uses: pneumonia and other respiratory diseases, mastitis, diphtheria, diarrhea Examples: sulfamethazine, sulfadimethoxine, sulfamerazine, sulfathiazole Foods of concern: milk; bovine, swine, and poultry tissue (muscle, liver, kidney); ﬁsh tissue Typical extraction: liquid–liquid extraction and/or SPE isolation Typical detection: reverse-phase (RP) LC with UV (270 nm) or LC/ﬂuorescence after derivatization Alternative methods: LC/MS/MS, supercritical extraction Comments: multiresidue methods available References: Parks and Maxwell (1994), Tsai and Kondo (1995), Gehring et al. (1997), Stoev and Michailova (2000), Van Eeckhout et al. (2000a)

B.

Beta-Lactams Uses: colibacillosis, bacterial enteritis, salmonellsis, etc. Examples: penicillin, ampicillin, amoxicillin, cloxacillin, cephapirin, ceftioﬂur Foods of concern: milk; bovine, swine, and ﬁsh tissue Typical extraction: liquid–liquid extraction (sometimes using tungstic or trichloroacetic acid) with SPE (usually C 18) cleanup Typical detection: RPLC/UV penicillins: 210–230 nm; cephalsosporins: 260–295 nm Alternative methods: derivatization to penicellenic acid mercuric mercaptide, derivatization with ﬂuorescamine, LC fractionation, LC/MS Comments: difﬁcult to analyze for all types simultaneously References: Boison and Keng (1998), Moats and Romanowski (1998), Luo and Ang (2000), Hong and Kondo (2000)

C.

Aminoglycosides Uses: used as broad-spectrum antibiotics, also to enhance growth efﬁciency Examples: streptomycin, apramycin, dihydrostreptomycin, gentamicin, neomycin Foods of concern: milk; bovine, poultry, and swine tissue (especially kidney) Typical extraction: liquid extraction with aqueous buffers, ion exchange columns Typical detection: RPLC/ﬂuorescence with derivatization or GC/electron capture Alternative methods: LC/MS Comments: usually need ion pair reagents for LC separation References: Heller et al. (2000), Isoherranen and Soback (1999)

D.

Tetracyclines Uses: to treat enteritis, pneumonia, and anaplasmosis, also to promote weight gain and increase feed efﬁciency Examples: tetracycline, oxytetracycline, chlortetracycline

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Foods of concern: milk; bovine, poultry, and swine tissue; shrimp; eggs; honey Typical extraction: mild acid with chelating agents, metal chelate afﬁnity columns Typical detection: RPLC or ion exchange with UV at 270–350 nm Alternative methods: LC/MS/MS, LC/ﬂuorescence of metal complexes Comments: oxalic acid or chelating agent used in LC mobile phase to avoid complexing with metals and adsorbing on silanol sites of column References: Oka et al. (2000), Moats (2000), Van Eeckhout et al. (2000b), Posyniak et al. (1999) E.

Macrolides Uses: to treat gram positive organisms and some strains of Listeria and Mycoplasma, promote growth efﬁciency Examples: erythromycin, tylosin, oleandomycin, spiramycin, tilmicosin Foods of concern: milk; bovine, poultry, swine, and ﬁsh tissue; eggs Typical extraction: liquid–liquid extraction and/or SPE isolation Typical detection: RPLC with UV or LC/ﬂuorescence after derivatization Alternative methods: LC/MS Comments: many have weak UV chromophores References: Kiehl and Kennington (1995), Chan et al. (1994), Leal et al. (2001), Stobba-Wiley et al. (2000)

F.

Quinolones Uses: broad-spectrum effective against gram positive, gram negative (ﬂuoroquinolones) and mycoplasma Examples: oxolinic acid, naladixic acid, saraﬂoxacin, enroﬂoxacin, ciproﬂoxacin, ﬂumequine Foods of concern: milk; bovine, poultry, swine, and ﬁsh tissue; eggs Typical extraction: liquid–liquid extraction and/or SPE cleanup using C 18 or cation exchange Typical detection: RPLC with ﬂuorescence and/or UV detection Alternative methods: on-line dialysis, LC/MS Comments: high level of concern regarding antibiotic resistance to these drugs References: Munns et al. (1995), Maxwell et al. (1999), Roybal et al. (1997), Rose et al. (1998)

G.

Phenicols Uses: infections, bovine respiratory disease Examples: chloramphenicol, ﬂorfenicol, thiamphenicol Foods of concern: milk; bovine, poultry, swine, and ﬁsh (including shrimp) tissue; eggs Typical extraction: liquid–liquid extraction and/or SPE isolation Typical detection: RPLC with UV or GC/electron capture after derivatization Alternative methods: GC/MS or supercritical ﬂuid extraction Comments: multiresidue methods available, ﬂorfenicol metabolized to amine References: Pfenning et al. (2000), Pensabene et al. (1999)

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H.

Ionophores Uses: coccidiostats, growth efﬁciency Examples: monensin, lasalocid, salinomycin Foods of concern: poultry, eggs, beef tissue Typical extraction: liquid–liquid extraction and/or SPE cleanup Typical detection: RPLC with visible or ﬂuorescence detection after derivatization Alternative methods: LC/MS Comments: present as sodium salts, weak chromophore References: Matabudul et al. (2000), Gerhardt et al. (1995)

I.

Benzimidazoles Uses: anthelmintics; growth efﬁciency Examples: albendazole, fenbendazole, oxfendazole, thiabendazole Foods of concern: bovine and swine tissue, milk (also fruits and vegetables) Typical extraction: liquid–liquid extraction and/or SPE isolation, MSPD Typical detection: RPLC with UV (290 nm) Alternative methods: LC/MS/MS Comments: multiresidue methods available References: Long et al. (1990), Sorensen and Hansen (1998), Balizs (1999)

J. Avermectins Uses: anthelmintics Examples: ivermectin, eprinomectin, doramectin, moxidectin Foods of concern: milk; bovine, swine, and ﬁsh tissue Typical extraction: liquid–liquid extraction and/or SPE isolation Typical detection: RPLC/ﬂuorescence after derivatization Alternative methods: LC/MS, postcolumn photochemical reaction Comments: multiresidue methods available References: Rupp et al. (1998). Roybal et al. (2000), Schenck and Lagman (1999), Danaher et al. (2001) K.

Hormones Uses: increasing weight gain Examples: estradiol, progesterone, and testosterone melengestrol acetate, trenbolone acetate, zeranol, and diethylstilbestrol (DES) Foods of concern: bovine and swine tissue Typical extraction: liquid–liquid extraction and/or SPE, LC fractionation Typical detection: GC/MS after derivatization Alternative methods: LC/MS Comments: approval for these drugs varies, DES banned worldwide References: Marques et al. (1998), Daeseleire et al. (1992, 1998). Hori and Nakazawa (2000)

L.

Corticosteroids Uses: anti-inﬂammatory and gluconeogenic agents Examples: dexamethasone, prednisolone, betamethazone, ﬂumethasone, prednisone, triamcinolone

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Foods of concern: bovine and swine tissue Typical extraction: liquid–liquid extraction (sometimes with the addition of NaOH), SPE Typical detection: GC/MS after derivatization, LC/UV (240 nm) Alternative methods: LC/MS, LC/chemiluminescence Comments: multiresidue methods available References: Mallinson et al. (1995), Stolker et al. (2000), Iglesias et al. (1999), Van Den Hauwe (2001)

IV. FUTURE TRENDS The most signiﬁcant trend in drug residue analysis is to increase the numbers of samples, residues, and matrices that can be monitored simultaneously. A higher throughput of samples being analyzed for more types of residues obviously increases the efﬁciency of monitoring. In addition to the rapid screening methods already discussed, there has also been an emphasis in developing determinative methods that will monitor more compounds more rapidly. For example, the development of generic, universal extraction methods that will extract many classes of drugs from a single sample (Rose et al., 1998; Heller and Cui, 2001). High throughput processing of samples using arrays of SPE columns developed for combinatorial chemistry applications in drug discovery may have relevance to the analysis of animal drug residues as well (Harrison and Walker, 1998). As mass spectrometry, particularly modern LC/MS, becomes more practical and affordable it has also been used to screen and perform quantitative analyses as well as just provide qualitative conﬁrmation. There are now several examples of methods where MS is used for multiresidue screening and analyses (Volmer, 1996; Heller and Cui, 2001; Stolker et al., 2000; Tarbin et al., 1998) Technological advances made in other areas of analytical, process, and food chemistry will have an effect on the analysis of drug residues in animal tissues. For example, the Biocore company in Switzerland has developed optical biosensors which have been used for the analysis of animal drug residues including the detection of sulfonamides in meat (Crooks et al., 1998; Bjurling et al., 1999). This technology has been used on-site at a slaughterhouse. Biochip array technology using immunoassay with chemiluminescence detection has been developed for the detection of growth promoters and sulfonamides (McConnell et al., 2000). All of these new technologies will have an impact on how animal drug residues are monitored and regulated in the future.

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9 Cleaning and Sanitizing a Food Plant PEGGY STANFIELD Dietetic Resources, Twin Falls, Idaho, U.S.A.

I.

INTRODUCTION AND DEFINITIONS

A. Introduction Cleaning a food processing plant is one way to make sure that there is no contamination from the raw ingredients to a ﬁnal product. To implement the cleaning process, the good manufacture practice (GMP) regulations issued by the U.S. Food and Drug Administration (FDA) serve as a frame of reference. The sources of information in this chapter include FDA current good manufacturing practice regulations FDA inspection operation manual FDA/state food codes FDA miscellaneous documents relating to the sanitation of a food processing plant and/or a foodservice establishment B. Deﬁnition of Terms Three deﬁnitions are germane to our discussion: 1. Cleaning. A process which will remove soil and prevent accumulation of food residues which may decompose or support the growth of disease-causing organisms or the production of toxins. 2. Sanitizing. A process which destroys disease causing organisms which may be present on equipment and utensils after cleaning. Chemical sanitizer used shall meet the requirements of 21 CFR 178.1010. 3. Soil. Soil has been appropriately deﬁned as ‘‘matter out of place’’; grease on a gear, for example, is a lubricant, but that same grease on a table top becomes soil. © 2003 by Marcel Dekker, Inc.

II. GENERAL CONSIDERATIONS IN SANITATION AND CLEANING Overall sanitation of the plant should be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions should be taken to ensure that the entire process, from raw ingredients to a ﬁnished product, does not contribute contamination from any source, including chemical, microbial, or extraneous material. Basic mechanical manufacturing steps include, among others, washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming. Note the following principles: Assure that all operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food will comply with basic sanitation and cleaning principles. Provide adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step. If applicable, clean and remove any contaminants. Require that all holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, are of a design and construction that enables them to be maintained in an appropriate sanitary condition. Treat compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment in such a way that food is not contaminated with unlawful indirect food additives. A.

Plants and Grounds

Keep the grounds about a food plant in a condition that will protect against the contamination of food. For example, Provide appropriate equipment storage, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant buildings or structures so that it will not become an attractant, breeding place, or harborage for pests. Maintain roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed. Drain areas that may contribute contamination to food by seepage or foot-borne ﬁlth or that provide a breeding place for pests. Provide sufﬁcient space for placement of equipment and storage of materials to permit sanitary operations and the production of safe food. Protect food in outdoor bulk fermentation vessels: Use protective coverings. Clean areas over and around the vessels to eliminate harborages for pests. Check on a regular basis for pests and pest infestation. Skim the fermentation vessels, as necessary. Inside a plant, some general considerations in cleaning are Clean and repair ﬂoors, walls, and ceilings. Eliminate drip or condensate from ﬁxtures, ducts, and pipes to avoid the contamination of food, food-contact surfaces, or food-packaging materials. © 2003 by Marcel Dekker, Inc.

Provide adequate ﬂoor drainage in all areas where ﬂoors are subject to ﬂoodingtype cleaning or where normal operations release or discharge water or other liquid waste on the ﬂoor. Assure that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact. For example, to clean a wall, the worker must have enough space to move around. In order to clean properly, one must be able to see. Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned. Provide safety-type light bulbs, ﬁxtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage. Maintain buildings, ﬁxtures, and other physical facilities of the plant in a sanitary condition, with regular repair and cleaning, all aimed at preventing food from becoming adulterated. Maintain the toilet facilities in a sanitary condition and keep them in good repair at all times. B. Equipment Cleaning and Maintenance 1. Procedures Written procedures should be established and followed for cleaning and maintaining equipment, including utensils and storage vessels, used in the manufacture, processing, packing, and holding of food or food ingredients. Procedures should, at a minimum, include Assigning responsibility for cleaning and maintaining equipment Establishing maintenance and cleaning schedules, including,where appropriate, sanitizing schedules Developing a complete description of the methods and materials used to clean and maintain equipment and, when necessary, instructions for disassembling and reassembling each article of equipment to ensure proper cleaning and maintenance Protecting clean equipment from contamination prior to use Inspecting equipment for cleanliness immediately before use, if practical Establishing the maximum time that may elapse between the completion of processing and equipment cleaning 2. Basic Requirements The minimal considerations in cleaning and sanitizing include All cleaning and sanitizing of utensils and equipment should be done properly to avoid contamination of food, food-contact surfaces, or food-packaging materials. Sanitizing agents should be adequate and safe. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is known to be effective and in compliance with voluntary or mandatory requirements. Cleaned and sanitized portable equipment with food-contact surfaces and utensils © 2003 by Marcel Dekker, Inc.

should be properly stored in a location that protects food-contact surfaces from contamination. All plant equipment and utensils should be so designed and of such material and workmanship as to be adequately cleanable and should be properly maintained. The design, construction, and use of equipment and utensils should preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces should be corrosion resistant when in contact with food. They should be made of nontoxic materials and designed to withstand the processing environment, the action of food, and, if applicable, cleaning compounds and sanitizing agents. Equipment that is in the manufacturing or food-handling area and that does not come into contact with food should be so constructed that it can be kept in a clean condition. Equipment and utensils and ﬁnished food containers should be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment should be taken apart for thorough cleaning. Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food should be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination. 3. Cleaning Methods Observe the following guidelines in the basics of cleaning methods: Equipment and utensils should be cleaned, held, and, where necessary, sanitized at appropriate intervals to prevent contamination or cross-contamination. Dedicated equipment should be cleaned at appropriate intervals to prevent the buildup of objectionable material or microbial growth. Nondedicated equipment should be thoroughly cleaned between different products and, if necessary, after each use to prevent contamination and cross-contamination. If cleaning a speciﬁc type of equipment is difﬁcult, the equipment may need to be dedicated to a particular operation or one operation only. The choice of cleaning methods, cleaning agents, and levels of cleaning should be established and justiﬁed. When selecting cleaning agents (e.g., solvents) the following should be considered: The cleaning agent’s ability to remove residues of raw materials, precursors, byproducts, and intermediates Whether the cleaning agent leaves a residue itself Compatibility with equipment construction materials For certain types of food processing, especially those requiring sampling for contamination, e.g., fermented food products, equipment cleaning methods should be validated, where appropriate. In general, cleaning validation efforts should be directed to situations or process steps where contamination or incidental carryover of residues poses the greatest risk to food safety. The cleaning validation protocol should describe the equipment to be cleaned, methods, materials, and extent of cleaning, parameters to be monitored and controlled, and © 2003 by Marcel Dekker, Inc.

analytical methods. The protocol should also indicate the type of samples (rinse, swabs) to be obtained, and how they are collected, labeled, and transported to the analyzing laboratory. Sampling should include swabbing, rinsing, or alternative methods (e.g., direct extraction), as appropriate, to detect residues (both insoluble and soluble) and microorganisms. For example, the sampling methods used should be capable of quantitatively measuring levels of residues remaining on the equipment surfaces after cleaning. Swab sampling may be impractical when product contact surfaces are not easily accessible due to equipment design and/or process limitations (e.g., inner surfaces of hoses, transfer pipes, reactor tanks with small ports). Equipment cleaning and sanitization studies should address microbiological and endotoxin contamination for those processes intended or purported to reduce bioburden or endotoxins in the other processes where such contamination may be of concern. Cleaning procedures should be checked by appropriate methods after validation to ensure these procedures remain effective when used during routine production. Where feasible, equipment should be examined visually for cleanliness. This may allow detection of gross contamination concentrated in small areas that could go undetected by analytical veriﬁcation methods. 4. Clean in Place Where feasible, clean-in-place (CIP) methods should be used to clean process equipment and storage vessels. Clean-in-place equipment should be designed and constructed so that Cleaning and sanitizing solutions circulate throughout a ﬁxed system and contact all interior food-contact surfaces. The system is self-draining or capable of being completely drained of cleaning and sanitizing solutions. CIP equipment that is not designed to be disassembled for cleaning should be designed with inspection access points to ensure that all interior food-contact surfaces throughout the ﬁxed system are being effectively cleaned. Clean-in-place methods might include ﬁll and soak/agitate systems, solvent reﬂuxing, high impact spray cleaning, spray cleaning by sheeting action, or turbulent ﬂow systems. Clean-in-place systems should be subjected to cleaning validation studies to ensure that they provide consistent and reproducible results. When practical, equipment in CIP systems should be disassembled during cleaning validation to facilitate inspection and sampling of inner product surfaces for residues or contamination, even though the equipment is not normally disassembled during routine use. Once CIP systems are validated, appropriate documentation should be maintained to show that critical parameters (e.g., time, temperature, turbulence, cleaning agent concentration, rinse cycles) are achieved with each cleaning cycle. C. Contact Surfaces All food-contact surfaces, including utensils and food-contact surfaces of equipment, should be cleaned as frequently as necessary to avoid contamination. Note the following: Food-contact surfaces used for manufacturing or holding low-moisture food should be in a dry, sanitary condition at the time of use. When the surfaces are wet© 2003 by Marcel Dekker, Inc.

cleaned, they should, when necessary, be sanitized and thoroughly dried before subsequent use. In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces should be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment should be cleaned and sanitized as necessary. Non–food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food. Food-contact surfaces should be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. Seams on food-contact surfaces should be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms. D.

Water

The primary constituent of all food processing plant cleaners is water. Basic water requirements common to all food processing operations are that it must be free from diseaseproducing organisms, toxic metal ions, and objectionable odors and taste. Pure water presents no problems, but no food processing establishment has an ideal water supply. Therefore, the cleaning compounds must be tailored to the individual water supply and type of operation. Water used for washing, rinsing, or conveying food should be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. The water supply should be sufﬁcient for the operations intended and should derive from an adequate source. Any water that contacts food or food-contact surfaces should be safe and of adequate sanitary quality. If needed, running water at a suitable temperature and under pressure should be provided in all areas where required for the processing of food; for the cleaning of equipment, utensils, and food-packaging materials; and for employee sanitary facilities. 1. Water Impurities and Cleaning Three groups of impurities in water can affect cleaning: 1. 2.

3.

Suspended matter must be kept to a minimum to avoid deposits on clean equipment surfaces. Soluble iron and manganese salts (concentrations above 0.3 ppm) will cause colored deposits on equipment surfaces. Suspended matter and soluble iron and manganese can be removed only by treatment. Water hardness.

2. Water Hardness Water hardness due to salts of calcium and magnesium presents a major problem in the use of cleaners by reducing effectiveness and by forming surface deposits. Types of hardness include © 2003 by Marcel Dekker, Inc.

Carbonate hardness (formerly called temporary hardness) due to calcium and magnesium carbonates and bicarbonates, which can be removed by heating Noncarbonate hardness (formerly called permanent hardness) due to calcium sulfates, calcium chloride, magnesium sulfate, and magnesium chloride, which cannot be removed by heating The hardness of waters varies considerably from place to place. In general, surface waters are softer than ground waters. Water hardness is classiﬁed as follows:

Class Soft Moderately hard Hard Very Hard

Grains per gallon

ppm per gallon

0–3.5 3.5–7.0 7.0–10.5 Over 10.5

0–59.85 59.85–119.70 119.70–179.55 Over 179.55

In terms of savings and effectiveness, the ideal water for general food plant cleaning purposes is completely softened water. However, a degree of hardness is often preferable in some food processing such as canning of certain vegetables.

III. FUNDAMENTALS OF CLEANING The basics of cleaning include four parts: 1. 2. 3. 4.

To To To To

bring a cleaning agent into intimate contact with the soil displace the soil from the surface to be cleaned disperse the soil in the solvent prevent redepositing of the dispersed soil back onto the clean surface

A. Deﬁnition of Functions Performed by Cleaning Agents The following provides a glossary of functions performed by cleaning agents: Deﬂocculation (or dispersion). The action in which groups or clumps of particles are broken up into individual particles and spread out suspended in the solution. Dissolving. The reaction which produces water-soluble materials from the waterinsoluble soil. Emulsiﬁcation. A process where fats are broken up into tiny globules and are suspended in the cleaning solution. Penetration. The action of liquids entering porous materials through cracks, pin holes, or small channels. Peptization. Physical formation of colloidal solutions from partially soluble materials. Saponiﬁcation. Action of alkali on fats resulting in the formation of soap. Suspension. The action in which insoluble particles are held in solution and not allowed to settle out onto the utensils. © 2003 by Marcel Dekker, Inc.

Rinsability. The action which breaks the surface tension of the water in the solution and permits the utensil to drain dry. Water softening. Water softening is accomplished by three chemical processes: 1. Precipitation. Softens-water by precipitating out the hardness 2. Sequestration. The action of an inorganic compound attaching itself to the water hardness particles and inactivates them so they will not combine with other material in the water and precipitate out 3. Chelation. The same as sequestration except that an organic compound is used Wetting. Action of water in contacting all soil; helps to reduce surface tension (wetting agents usually do a good job of emulsiﬁcation). Synergism. A chemical used as a builder with a soap or detergent, which results in a detergency that is greater than the total detergency of the chemical and the soap if they were used independently. B.

Factors Affecting Cleaning Efﬁciency

The proper selection of the cleaner to do the job, the concentration of cleaner, the time in contact with the surface, and the force, velocity, and temperature used are all important to effective cleaning. Each of these can be varied independently to adjust a cleaning operation to a particular problem or plant operating practice. These factors will vary from hand cleaning to circulation cleaning and will depend upon the type and condition of soil to be removed. The functions of various factors are The cleaner. Temperature. Increasing temperature (1) decreases the strength of bond between soil and surface, (2) decreases viscosity, (3) increases solubility of soluble materials, and (4) increases chemical reaction rate. Velocity or force. In hand cleaning, force is applied by ‘‘elbow grease,’’ where ﬂuid ﬂow is used to apply cleaning force in CIP systems. Increased turbulence provides more effective removal of ﬁlm from surfaces. However, efﬁciency is less effected by turbulence as the physical–chemical effectiveness of the detergent increases. A CIP cleaning velocity of 5 ft/sec is recommended to ensure adequate turbulence. Time. All other factors remaining constant, cleaning efﬁciency can be increased by utilizing longer times. Concentration. Increased concentration increases the reaction rate. It is the least effective of the ﬁve variables to change in cleaning. C.

Desirable Properties of Good Cleaners

The following lists the most desirable properties of a good cleaner for a food processing plant: Quick and complete solubility Good wetting or penetrating action Dissolving action on food solids Emulsifying action on fat © 2003 by Marcel Dekker, Inc.

Deﬂocculating, dispersing, or suspending action Good rinsing properties Complete water softening power Noncorrosive on metal surfaces Germicidal action Economy in use

IV. CLEANING METHODS A. Cleaning Methods 1. Removal of Gross Food Particles Loose material should be removed before the application of cleaning solutions. This may be accomplished by ﬂushing the equipment surface with cold or warm water under moderate pressure. Very hot water or steam should not be used because it may make cleaning more difﬁcult. 2. Application of Cleaning Compounds There are many methods of subjecting the surfaces of equipment to cleaning compounds and solutions. Effectiveness and the economy of the method generally dictate its use: Soaking. Small equipment or ﬁttings or valves may be immersed in cleaning solutions in a sink, while larger vessels such as vats and tanks may be partially ﬁlled with a predissolved cleaning solution. The cleaning solution should be hot (125°F; 52°C) and the equipment permitted to soak for 15–30 min before being manually or mechanically scrubbed. One relatively recent approach is the ultrasonic cleaning tanks in which equipment is immersed in a cleaning solution and cleaned by the scrubbing action of microscopic bubbles caused by high frequency vibrations (20,000–40,000 cycles per second). Spray methods. Cleaning solutions may be sprayed on equipment surfaces by use of either ﬁxed or portable spraying units using either hot water or steam. These methods are extensively used in the food industry. Clean in place systems. This method is an automated cleaning system generally used in conjunction with permanent-welded pipeline systems. In CIP cleaning, ﬂuid turbulence in pipelines is considered to be the major source of energy required for soil removal. Abrasive cleaning. Abrasive-type powders and pastes are still available and used for removing difﬁcult soil. Complete rinsing is necessary and care should be taken to avoid scratching stainless steel surfaces. Scouring pads should not be used on food-contact surfaces because small metal pieces from the pads may serve as focal points for corrosion or may be picked up in the food. Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures should be free from undesirable microorganisms and should be safe and appropriate for the intended objectives, i.e., used in cleanings. Identify, hold, and store toxic cleaning compounds, sanitizing agents, and pesticide chemicals to protect food-contact surfaces and food-packaging materials. © 2003 by Marcel Dekker, Inc.

3. Rinsing All equipment surfaces should be thoroughly rinsed with clean potable water immediately after being cleaned in order to remove all traces of the cleaning solution. Very hot water may be desirable to decrease drying times.

V.

SANITIZING

The primary reason for the application of effective sanitizing procedures is to destroy those disease organisms which may be present on equipment or utensils after cleaning, and thus prevent the transfer of such organisms to the ultimate consumer. In addition, sanitizing procedures may prevent spoilage of foods or prevent the interference of microorganisms in various industrial processes which depend on pure cultures. The FDA has provided a list of those agents it has approved for sanitizing equipment (178 CFR 1010). A.

Chemical Sanitizing Agents

There are a wide variety of known chemicals whose properties destroy or inhibit the growth of microorganisms. Many of these chemicals, however, are not suitable for use on food-contact surfaces because they may corrode, stain, or leave a ﬁlm on the surface. Others may be highly toxic or too expensive for practical use. Therefore, the discussion on chemical sanitizing agents will be restricted to those agents in common use in the food industry. 1. Chlorine Chlorine and its compounds combine indiscriminately with any and all protein and protoplasms. The mode of bactericidal action is thought to be the reaction of chlorine with certain oxidizable groups in vital enzyme systems. a.

Inorganic Chlorine Products.

Types in common use include

Calcium hypochlorite—generally in powder form of 70% available chlorine Sodium hypochlorites—generally in aqueous solution of 2–15% available chlorine Characteristics and limitations are as follows: Effective sanitizer if high enough residual used Organic matter may cause a substantial reduction in bactericidal effectiveness. Temperature and pH may exert marked inﬂuence upon the bactericidal effectiveness. Relatively unaffected by water hardness. No ﬁlm left on surface but may leave odor or taste. Bactericidal activity if (is?) good against a wide variety of microorganisms. b.

Organic Chlorine Products.

Types include

Chloramine-T—in powdered form of 25% available chlorine Dichlorocyanuric and trichlorocyanuric acids—in powdered form of 70–90% available chlorine © 2003 by Marcel Dekker, Inc.

Characteristics and limitations include Slower bactericidal action than hypochlorites. Factors affecting hypochlorites similarly affect organic chlorine compounds. Relatively nonirritating to skin. 2. Iodophors Iodophors are soluble complexes of iodine combined usually with nonionic surface-active agents, loosely bound. Characteristics and limitations are as follows: Rapid bactericidal action in acid pH range in cold or hard water Less affected by organic matter than hypochlorites Nontoxic in ordinary concentration Noncorrosive, nonirritating to skin Yellow or amber color of solution is proportional to concentration Less effective against bacterial spores than hypochlorites Does not stain; only minimal taste and odor 3. Quaternary Ammonium Compounds Quaternary ammonium compounds (QACs) compounds are synthetic surface-action agents. The most common ones are the cationic detergents, which are poor detergents but excellent germicides. In these compounds, the organic radical is the cation, and the anion is usually chlorine. The mechanisms of germicidal action is not completely understood, but is associated with enzyme inhibition and leakage of cell constituents. Types of compounds include Alkyl dimethyl benzyl ammonium chloride; alkyl dimethyl ethylbenzyl ammonium chloride. These compounds are effective in water ranging from 500 to 1100 ppm hardness without added sequestering agents. Diisobutyl phenoxy ethoxy ethyl dimethyl benzyl ammonium chloride; methyl dodecyl benzyl trimethyl ammonium chloride. These compounds require sodium tripolyphosphate to raise hard water levels to a minimum of 500 ppm. Characteristics and limitations are as follows: Require high dilution for germicidal or bacteriostatic action Very selective in destruction or inhibition of various types of organisms Form bacteriostatic ﬁlm on surface after treatment Noncorrosive and nonirritating to skin No taste or odor in used dilutions More stable in presence of organic matter than some other chemical sanitizers Incompatible with soap, anionic detergents, and inorganic polyphosphate Difﬁcult to accurately measure residual 4. Factors Affecting Action of Chemical Sanitizers In order for a chemical to react with microorganisms. It must achieve intimate contact. a. Concentration of Sanitizer. In general, the more concentrated a sanitizer, the more rapid and certain its actions. Increases in concentration are usually related to exponential increases in effectiveness until a certain point when it accomplished less noticeable effectiveness. Minimum concentrations are as follows: © 2003 by Marcel Dekker, Inc.

Chemical agent

Minimum concentration (ppm)

Hypochlorites Chloramine-T QACs Iodophors

50 200 200 12.5

For sanitization of assembled equipment, the solution strength should be checked at the outlet end. When it is in excess of the minimum concentrations, the solution should be pumped through the entire equipment for at least 1 min. b. Temperature of Solution. All of the common sanitizers increase in activity as the solution temperature increases. This is partly based on the principle that chemical reactions in general are speeded up by raising the temperature. However, a higher temperature also generally lowers surface tension, increases pH, decreases viscosity, and effects other changes which may enhance germicidal action. It should be noted that chlorine compounds are more corrosive at high temperatures and iodine tends to sublime at temperatures above 120°F (49°C). c. pH of Solution. The pH of the solution exerts a very pronounced inﬂuence on most sanitizers. Quaternary compounds present a varied reaction to pH depending on the type of organism being destroyed. Chlorine and iodophors generally decrease in effectiveness with an increase in pH. d. Time of Exposure. Sufﬁcient time must be allowed for whatever chemical reactions that occur to destroy the microorganism. The required time will not only depend on the preceding factors, but on microorganism populations and the populations of cells having varied susceptibility to the sanitizer due to cell age, spore formation, and other physiological factors of the microorganisms. B.

Physical Sanitizing Agents

1. Heat a.

Moist Heat. hot water. An effective, nonselective sanitization method for food-contact surfaces;however, spores may remain alive even after an hour of boiling temperatures. The microbicidal action is thought to be the coagulation of some protein molecules in the cell. The use of hot water has several advantages in that it is readily available, inexpensive, and nontoxic. Sanitizing can be accomplished by either pumping the water through assembled equipment or immersing equipment into the water. When pumping it through equipment, the temperature should be maintained to at least 170°F (77°C) for at least 5 min as checked at the outlet end of the equipment. When immersing equipment the water should be maintained at a temperature of at least 170°F for 1–5 min depending on the size of the equipment. steam. Steam is an excellent agent for treating food equipment. Treatment on heavily contaminated surfaces may cake on the organic residues and prevent lethal heat to penetrate to the microorganism. Steam ﬂow in cabinets should be maintained long © 2003 by Marcel Dekker, Inc.

enough to keep the thermometer reading above 170°F for at least 15 min or above 200°F (93.3°C) for at least 5 min. When steam is used on assembled equipment, the temperature should be maintained at 200°F for at least 5 min as checked at the outlet end of the assemble equipment. b. Dry Heat. Hot air ovens and chambers are not generally used because the method requires longer times and higher temperatures. When such equipment are used, the temperature must be at least 180°F (82.2°C) for a holding period of at least 20 min. 2. Ultraviolet Radiation and New Technology Low pressure mercury vapor lamps, which produce effective bactericidal action by the ˚ , have had limited use in the food emission of radiation at a wavelength of around 2500 A industry. Major application has been with disinfection of air. However, installations of lamps have been reported on bread-slicing machines, over open vats in breweries, and in chill rooms for meats. Bacterial resistance will highly inﬂuence the lethal exposure time. Moreover, the light rays must actually strike the microorganisms because the rays are absorbed by dust, thin ﬁlms of grease, and opaque or turbid solutions. In the last few years, many new technologies for cleaning a food processing plant began to emerge. This book is not designed to go into details on such topics. Standard reference sources should be consulted.

VI. EXAMPLES OF INSANITARY CONDITIONS IN A FOOD PROCESSING PLANT The FDA has various methods of enforcing its laws and regulations. Inspecting a food plant is one of them. For some companies, the deﬁciencies in sanitary conditions may elicit a warning letter from the FDA. The following are some examples (from warning letters) of such deﬁciencies from a failure in doing an adequate job in cleaning a food plant. A. Pests Live and dead insects (i.e., cockroaches, ﬂies, apparent weevils, and gnats) on, in, and around raw materials, in-process food, ﬁnished product, and equipment B. Equipment and Residues Equipment encrusted/covered with old apparent product residue or extraneous materials used in the manufacture of food products. The interior surface of the ice-making machine had old food residues and the icedispensing scoop was stored on top of a soiled measuring scale. The surfaces of the mixer-blender, meat slicer, and can opener all had a build-up of old food residues. The food cart shelves in the food preparation area and the refrigerator racks had a build-up of old food residues. © 2003 by Marcel Dekker, Inc.

C.

Washing and Sanitizing There was no sanitizing solution available to sanitize utensils and equipment. There was no three-compartment sink available to wash, rinse, and sanitize utensils and equipment. There was no chemical test kit or other device available to measure the concentration of the sanitizing solution. The chemical concentrations of iodine at four sanitizer stations were measured and found to be too low to adequately sanitize the utensils and equipment.

D.

Garbage and Waste Three 50-gallon trash cans in the food preparation area were overﬁlled with garbage, and garbage was spilling onto the ﬂoor. Trash was not disposed of on a regular schedule. The ground surfaces under both the trash compactor and the container holding soda cans for recycling had a strong foul odor. The ground surface in the loading dock area had a pool of standing murky water and a build-up of trash and garbage.

E.

Floors The ﬂoor drains in the food preparation area were clogged with old food residue. The ﬂoor areas throughout the facility and along the walls were not clean, i.e., areas around the dish washer, food preparation, and refrigerator. The ﬂoors in the three refrigerators were cracked, soiled with food debris, and worn from deterioration and disrepair.

ACKNOWLEDGMENT Data in this chapter have been modiﬁed with permission from publications prepared by Science Technology System, West Sacramento, CA.

© 2003 by Marcel Dekker, Inc.

10 Water in Food Processing CHUN-SHI WANG and JAMES SWI-BEA WU National Taiwan University, Taipei, Taiwan PHILIP CHENG-MING CHANG National Taiwan Ocean University, Keelung, Taiwan

I.

INTRODUCTION

Water is an essential element for the existence of life. Many physiological reactions have to occur in water solution. Where water is present, life is possible. Where it is absent, life can not sustain. Water is one of the most abundant substances on earth. However, the quantity of water that is available for human beings to use without laborious treatment is very limited; for example, only 1% of the world’s total is freshwater [1]. Therefore, it is important to make the best utilization of water. Water can be the most crucial component in the processing of most food products. It is often used as the medium for washing, heating, and cooling as well as for the cleaning and sanitation of equipment and facilities. Water is a food ingredient itself and also the vehicle that carries other ingredients such as sodium chloride during formulation. The demand for water in the food industry keeps increasing because (1) more food is being produced; (2) foods are more apt to be intensively processed; (3) there is increased emphasis on cleanliness and good sanitation; (4) mechanical harvesting leads to more dirt and debris on produce that must be washed off; and (5) the use of water for conveying food in the processing plant is increasingly common [2]. To cope with the ever-growing demand, food processors ought to use water more efﬁciently, either by developing processing operations that utilize less water or by reconditioning and recycling a higher percentage of water within the food plant.

© 2003 by Marcel Dekker, Inc.

II. SOURCES AND PROPERTIES OF WATER Water from different sources may have different physical, chemical, and biological properties. It may require different treatments to meet the same quality standards for a speciﬁc usage. Some plants may have an alternative water supply to make up the deﬁciency in quantity or quality of their own source. For example, they may purchase municipal water and treat it for sanitary utilization, while relying on their own source of water only for nonsanitary operations because of its lack of cleanliness. A.

Surface Water

Surface water is deﬁned as all the water open to the atmosphere and subjected to surface runoff. Water in streams, rivers, brooks, lakes, and reservoirs is included in this category. The quality of surface water is inﬂuenced by the location of the collection point where water is diverted for treatment. Quiescent water bodies, whether natural or human-made, are living ecosystems. Their speciﬁc properties may change from time to time, often accelerated by human activities. The major sources of pollution for surface water are fertilizers and other agricultural chemicals that have been applied to the ﬁeld, industrial wastes, sewage, and decayed materials of animal or plant origin. The quality of streams, rivers, and brooks may also vary with seasons. Rapid changes in quality including turbidity may occur right after heavy precipitation and accidental spills [3]. In these occasions, much greater capacity in treatment and closer attention among operators than that in normal operation conditions are required. Lakes and impounding reservoirs also have seasonal variations in water quality, but these variations usually occur at a slower rate than those of streams and rivers [4]. Generally speaking, water from lakes and reservoirs contains less precipitable solids, primarily because there is sufﬁcient retention time to permit settling [2]. As a result, water from reservoirs and lakes is often easier to ﬁlter and purify, although it may be inherently less pure than river water due to the greater impact from microbiological activity. B.

Ground Water

All water beneath the land surface is referred to as underground, or subsurface water [5]. Underground water occurs in two different zones. One is right beneath the land surface, called the unsaturated zone, while the other is at greater depths where all the empty spaces are completely ﬁlled with water, and it is therefore called the saturated zone, with the water table being the upper surface [6]. The term ground water refers only to the water in the saturated zone. Ground water originates from either springs or wells, and the sanitary conditions are much the same as long as it is properly protected during and after rising to the surface. The contaminants in ground water may be from surface water and sewage. Springs, inﬁltration galleries, shallow wells, and other collectors in subsurface aquifers may be hydraulically connected to nearby surface water sources, depending on local geology [7]. Floods may also allow surface water to enter the well and produce contamination [8]. Sewage can enter wells if they ﬂood or are located too close to cesspools, septic tanks, or associated drainage ﬁelds. A small quantity of contaminated ground water may enter a well without sufﬁcient natural ﬁltration and percolation to remove impurities and contaminate a much large quantity of clean ground water [2]. © 2003 by Marcel Dekker, Inc.

Ground water quality is usually superior to that of surface water with respect to microbial content, turbidity, and total organic concentrations [4]. However, the mineral content (hardness, iron, manganese, etc.) of ground water may be so high that a softening treatment is required. The quality, especially the concentrations of chemicals such as pesticides, herbicides, and solvents, is of great concern for the safe use of ground water in food processing [9]. C. Seawater Seawater is usually drawn up from deep sea at some distance from shore for conveying and cleaning ﬁsh on ﬁshing boats and in seafood processing operations [10]. This water is simply ﬁltered to remove debris of large size, and further puriﬁcation is not considered necessary for the purposes intended [2]. There is an inherited freshwater shortage problem in some countries, especially in the Middle East. Desalination of seawater to create a water source of good quality is an adequate solution for these countries [11]. D. Public Water Systems Potable water, commonly known as ‘‘drinking water,’’ means water that meets the U.S. ‘‘National Primary Drinking Water Regulations’’ (40 CFR 141), the World Health Organization’s ‘‘International Standards for Drinking Water,’’ or other recognized equivalent standards. A public water system is an approved water source and is convenient for the food industry to use. E.

Reuse of Water

The need to conserve water through reuse is crucial given the ﬁnite nature of this resource and increasing demands for its use in domestic, agricultural, and manufacturing activities. There is 5–10 m 3 of wastewater produced for each ton of food product processed in Germany [12]. Water having an organic concentration, measured as total organic carbon (TOC), below 300 mg/L and an inorganic concentration below 2200 µS/cm is deﬁned as low-contaminated water that is reusable in the food industry. It constitutes up to 30% of the total wastewater quantity in a food plant [13]. Food processors can make a prudent reuse of wastewater through proper treatments to recondition it. The reconditioning includes reduction in the total suspended solids content (TSS), biological oxygen demand (BOD), and chemical oxygen demand (COD). Reusing water saves not only the initial water cost, but also the cost of disposing of the liquid waste because sewage charges are usually based on volume as well as TSS, BOD, and COD of the efﬂuent. Table 1 shows some examples of water reuse in food plants.

Table 1

Occurrence of Water Reconditioning in Different Food Processing Sectors

Application Egg washing water Pickling brine Surimi processing brine Hydrocooling water Chiller shower water

© 2003 by Marcel Dekker, Inc.

Treatment

Reference

Addition of sanitizer Addition of sodium chloride Removal of proteins Addition of chlorine dioxide Membrane and UV

14 15 16 17 13

Recycled water obtained from a food manufacturing operation, reconditioned if necessary, may be reused in the same or another food manufacturing operation. Reuse water shall not jeopardize the safety of the product through the introduction of chemical, microbiological or physical contaminants in amounts that represent a health risk to the consumer. Therefore, water from sources that are in contact with or include human or agricultural sewage should not be upgraded for reuse [18]. Also, unless reconditioned to potable quality, distribution of reuse water should be in systems separated from the distribution lines for potable water. Nor shall reuse water jeopardize the organoleptic property of the product. Recirculated water is water reused repeatedly in a closed loop for the same manufacturing operation. It can be untreated, treated to remove particulate matters, or added with a disinfectant if the period of recirculation is long. III. WATER UTILIZATION FOR FOOD PROCESSING There is no standard quantity of water utilization in the processing of food. Few food plants use no water at all, while many of them consume very large quantities. Food processing sectors vary in their major purposes for using water. For instance, 60% of the water used by meat processors is for cooling purposes, 62% of the water used by sauce manufacturers is for cleaning; while starch millers use 55% of water for granule separation. Water serves multiple functions in the processing of food, including cleaning, conveying, steam generation, heat exchange, and as an ingredient, etc. A.

Cleaning

The use of water for cleaning involves washing plant structures and surfaces, equipment, raw materials, and in some cases, the ﬁnished products. The purposes of cleaning the plant and equipment are sanitation and removing undesirable residues from a processing line. Raw materials such as fruits and vegetables also require cleaning because modern mechanized harvesting leaves extensive soil residue on their surfaces. Hard water is a problem in households and manufacturing facilities when it hinders the ability for soaps and detergents to form lather. For this reason, hard water is often softened to remove calcium and magnesium ions. The hot water supply shall be sufﬁcient to satisfy the peak demands of the establishment. Hot water for handwashing shall be at a temperature no lower than 55°C (110°F), while for mechanical dishwashing shall be 66–74°C (150– 165°F) in the washing stage and 74–82°C (165–180°F) for sanitizing. The temperature of the wash solution in spray-type warewashers that contain chemical sanitizers ought not to be lower than 49°C (120°F). The temperature for manual hot water sanitization needs to be no lower than 77°C (171°F) [19]. B.

Conveying

Water is widely used for conveying in the fruit and vegetable processing industry. In many cases, cleaning and conveying are done at the same time. Wherever practical, conveying water is reused after reconditioning. Fluming in a water pumping system is a common method of transporting product from one corner of the factory to another, and, as mentioned, the water used often is recycled. The proper diameter of pipes used for this purpose depends on the size of the product to be conveyed. One of the major difﬁculties with transportation by ﬂuming is the tendency for the food product to contact and adhere to © 2003 by Marcel Dekker, Inc.

the inner surface of the conveying duct, thus becoming a focus for microbial growth [20]. When this happens, such pipes shall be disassembled periodically, depending on the buildup rate, and scrubbed thoroughly to remove the deposit. C. Steam Generation Steam is used to heat, peel, humidify, and clean in the food industry. As a result, the water for steam generation is considered a food ingredient that ought to meet the regulatory requirements for potable water. For alleviating the corrosion problem in boilers and steam ducts, corrosion inhibitors and water-conditioning compounds may be added to water before it is fed into a boiler to generate steam. These materials are regarded as food additives by regulatory authorities and their use in process steam generation is controlled accordingly [21]. D. Heat Exchange It is common to use water or a water solution to heat or to cool in the food industry. In fact, more water is used for cooling than for any other process [22]. There are two types of cooling system in food plants. One is a closed-loop cooling system where water does not contact with food; the other is a cooling canal system where water contacts with food directly. The closed-loop system involves equipment such as a cooling tower for the liberation of heat to the atmosphere. In the cooling canal system the velocity of water should be adequate to agitate and ﬂoat off loose particles in an overﬂow and meanwhile to keep the raw materials submerged. Water may also be frozen to ice and then used as a cooling medium, in contact with the produce directly or mixed with water to form slush in a cooling canal. Ice bank formation in the closed-loop system becomes common in modern industry as a way of utilizing cheap off-peak energy. When fruits and vegetables are heated in water, the amount of calcium ions in the medium may inﬂuence the texture of the product. For example, calcium ions may crosslink with low-methoxyl pectin that is beneﬁcial for maintaining ﬁrmness in cooked fruits and vegetables [23]. However, cooking in water containing excessive amounts of calcium ions may result in a product with unacceptably tough texture. Peas and beans that are cooked in high-calcium water and then dried will be difﬁcult to rehydrate [24]. E.

Ingredient

This occurs when the water eventually becomes a constituent of the food. It should be of the highest purity and potability. A good example of water as a food ingredient is in the making of soft drinks. Water is mixed directly with syrup, then is carbonated, bottled, and pasteurized. The water needs to be softened before use because hard water can cause unwanted cloudiness in the soft drink [25]. In a jam-producing plant, if alginate is used for jelling, the calcium ion content in water has to be controlled; if κ-carrageenan is used, the potassium ion content in water has to be controlled instead [26]. Chlorinated water may sometimes be an unsatisfactory ingredient because chlorine can cause taste and odor problems [27]. IV. WATER PURIFICATION OPERATIONS As water travels over the land’s surface or through the ground or is reused in the food plant, it may pick up various kinds of contaminants including microbials, such as viruses © 2003 by Marcel Dekker, Inc.

Table 2 Water Puriﬁcation Treatments and Their Functions Nature of treatment

Function

Physical

Removal of solids and some microorganisms

Biological

Reduction of BOD, COD, TSS, and TOC

Chemical

Removal of organic and inorganic materials, removal of ions and dissolved solids, or reduction of microorganisms

Treatment Absorption Bubble separation Centrifugation Coagulation Filtration Sedimentation Aerobic biodegradation Anaerobic biodegradation Chemical precipitation Disinfection Ion exchange

and bacteria; inorganic substances, such as salts and metals; pesticides and herbicides; organic compounds from industrial processes; radioactive contaminants; etc. Certain puriﬁcation treatments are required to ensure the water is suitable for processing and safe for the public to use or drink. A treatment can be physical, biological, or chemical in nature (Table 2). The purpose of a treatment can be clarifying, deodorizing, softening, or disinfecting, as described in the following sections. A.

Clariﬁcation

Clariﬁcation reduces the amount of suspended solids. Many pollutants of concern to human health are solid particles themselves (e.g., pathogenic organisms) or are associated with solid particles (e.g., certain toxic metals) [28]. Clariﬁcation involves, but is not limited to, the following treatments. 1. Coagulation Coagulation is a treatment to promote aggregation of small particles into large particles that can be removed by subsequent sedimentation and/or ﬁltration processes. Coagulation destabilizes particulate suspensions in water. Particulate suspensions that are commonly removed with coagulation include clay- and silt-based turbidity, natural organic matters, and other associated constituents, such as microbial contaminants, toxic metals, synthetic organic chemicals, iron, and manganese. The associated contaminants often adsorb to or combine with turbidity and natural organic suspensions, thus enabling their removal by coagulation treatments [4]. Coagulation usually proceeds in three steps, namely, coagulant formation, particle destabilization, and particle aggregation. In the rapid-mixing stage of a coagulation treatment coagulant forms and particles destabilize as a response to the hydrolization and dispersion of the chemical additive. Particle aggregation is then promoted in a ﬂocculation stage, where interparticle collisions create larger particles amenable to separation from the treated water [28]. © 2003 by Marcel Dekker, Inc.

Alum and iron salts are the most common chemical additives used in the coagulation treatment of water. The most common rapid-mixing equipment used in the treatment is a back-mix mechanical reactor. Other rapid-mixing equipment includes in-line blenders, hydraulic jumps, motionless static mixers, and diffuser injection devices. Flocculation is typically performed in a basin bafﬂed into three or more compartments, with mechanical mixing provided in each stage to promote interparticle collisions and aggregation [4]. 2. Sedimentation Sedimentation and ﬂotation are solid–liquid gravity separation treatments to reduce the quantity of suspended solids in water. A sedimentation treatment promotes gravity settling of solid particles to the bottom of the water column, where they are accumulated and removed. Flotation treatments introduce gas bubbles into water that attach to solid particles and create bubble/solid agglomerates. The agglomerates then ﬂoat to the top of the water column to be removed [4]. Sedimentation is particularly necessary for high-turbidity water, which may release a substantial quantity of solids during coagulation or ﬂocculation treatments. Sedimentation may also be employed at the head of a water treatment in a so-called presedimentation basin to allow gravity settling of dense solids that do not require any coagulation or ﬂocculation treatment to be separated from water. Flocculation is used ahead of sedimentation for algal-laden, low-turbidity, low-alkalinity, or colored water that contains low-density particles [4]. 3. Filtration Filtration is a major treatment that removes suspended particulate materials from water. Among the materials usually removed are clay and silt, colloidal and precipitated natural organic matters, metal salt precipitates from coagulation, lime-softening precipitates, iron and manganese precipitates, and microorganisms. Granular media ﬁlters are the most common types of ﬁlter used in the treatment for potable water. The pore volume, pore size, and pore tortuosity of the ﬁlter affect its solidsholding capacity, head loss characteristics, ﬁltrate quality, and backwash ﬂow requirements. The ﬁlter is usually made of sand, crushed anthracite coal, garnet, ilmenite, or granular activated carbon. Filters can be speciﬁed by the rate of ﬁltration, that is, the ﬂow rate per unit area. They can also be classiﬁed as depth ﬁltration ﬁlters if the solids are removed within the granular material or cake ﬁltration ﬁlters if the solids are removed on the entering face of the granular material. Rapid granular-bed ﬁlters are among the former group, while precoated and slow sand ﬁlters are among the latter group. Cartridge ﬁlters are available for various point-of-use ﬁltration applications. They are usually pressure ﬁlters with a medium comprised of membrane, fabric, or string. The medium is supported by a ﬁlter element and housed in a pressure vessel. The cartridge is generally disposed of after a single ﬁlter cycle. Cartridge ﬁlters are usually rated by their manufacturers as to the particle size to be retained, with the smallest being about 0.2 µm and the largest going up to about 10 µm. Smaller retained particle sizes result in lower ﬂow rates, higher pressure requirements, and a shorter operating period before replacement [29]. 4. Membrane Processes Membrane processes include reverse osmosis (RO), ultraﬁltration (UF), and nanoﬁltration (NF). They are emerging as viable potable water treatment processes for removing particu© 2003 by Marcel Dekker, Inc.

lates, color, trihalomethane precursors, and some inorganic substances. The common component shared among the various membrane processes is a membrane able to reject or select passage of certain dissolved species based on size, shape, and/or charge. The performance and limitations of membrane processes depend on several factors. The speciﬁc quality of the feed water and desired quality of the product water shall be considered in the selection of system [30]. Generally, the more contaminated the feed water and the higher the desired product water quality, the greater the likelihood of membrane fouling caused by particulate matter, scaling, and biofouling [31]. Common practices to overcome the fouling problem include pH control, addition of antiscalants and compatible biocides that can also prevent membrane decomposition [32]. 5. Biological Treatment Water containing nonnegligible concentrations of biodegradable materials is described as biologically instable. Biologically instable water may allow pronounced bacterial growth in subsequent processes. In the distribution system, biodegradation of the instable materials can create undesirable odors or taste and increase turbidity and the rate of corrosion [33]. Water from which nearly all of the biodegradable materials have been removed is called biologically stable [34]. Placing biological treatment as one of the initial processes is most advantageous because early removal of biodegradable materials guards against slime build-up during coagulation and ﬁltration and eliminates the need for chlorination beyond that required for pathogen destruction. Bioﬁlm formation is a method to prepare biologically stable water [35]. The bacteria are attached as a naturally occurring ﬁlm on solid media such as small rocks, stones of pozzolana, particles of expanded clay, ﬂuidized particles of sand or slit, or plastic media. In bioﬁlm reactors, water usually ﬂows by quickly, with a detention time of only a few minutes. An important design criterion for a successful bioﬁlm process is to obtain a high speciﬁc surface area to maximize the volumetric reaction rate [36]. B.

Deodorization

Treated water can be very safe to drink yet still have an unpleasant taste and odor because of the activity of some microscopic organisms such as algae [37], especially during hot summer months. The purpose of deodorization is to remove the taste and odor in water. 1. Air Stripping and Aeration Air stripping and aeration can be deﬁned as a treatment to bring water into contact with air in order to expedite the transfer of a gas between the two phases. Historical applications of aeration include the removal of hydrogen sulﬁde that causes off-taste and smelly odors, carbon dioxide to reduce the demand of lime in the subsequent softening treatment, and trace volatile organic contaminants. Packed tower, diffused aeration, spray nozzles, and tray aerators are the common equipment used [38]. 2. Adsorption Adsorption of a substance involves its accumulation at the interface between two phases, such as a liquid and a solid or a gas and a solid. The molecule species that accumulates, or adsorbs, at the interface is called an adsorbate, and the solid on which adsorption occurs is the adsorbent. Adsorbents of interest in water treatment include activated carbon; adsorbent resins; metal oxides, hydroxides, and carbonates; activated alumina; clays; and © 2003 by Marcel Dekker, Inc.

other solids that are suspended in or are in contact with water. Powdered activated carbon (PAC) is commonly used for controlling seasonal taste and odor problems experienced in surface water supplies. Typical dosage ranges from 1 to 50 mg/L, and the effectiveness is water-source speciﬁc and difﬁcult to predict without performing bench, pilot, or fullscale tests. Granular activated carbon (GAC) is far more effective than PAC as an adsorbent. The retention time of water in the treatment, given a feed water quality and desired ﬁnished water quality, determines the size of the GAC contactor and the activated carbon usage rate [39]. C. Softening Softening is used to remove the cation contaminants such as calcium, magnesium, barium, strontium, and radium ions and anion contaminates such as ﬂuoride, nitrate, fulvates, humates, arsenate, selenate, chromate ions, and anionic complexes of uranium. The technology of chemical precipitation or ion exchange may soften water to prevent texture and color changes in certain foods, improve the effectiveness of bottle-washing operations, and lessen the accumulation of mineral deposits within pipes, ducts, and equipment. 1. Chemical Precipitation Chemical precipitation is one of the most common treatments for water softening as well as iron and manganese removal. The effectiveness of removing substances from water by precipitation depends primarily on the solubility of the complexes formed after the addition of chemicals. Lime, lime/soda ash, and caustic soda are the chemicals usually used in water precipitation treatment. During the process, calcium is removed in the form of calcium carbonate (CaCO 3), while magnesium is removed as magnesium hydroxide [Mg(OH) 2]. Concentrations of various carbonic species and pH play an important role. Water right after the precipitation treatment usually has a pH of 10 or greater that may easily cause the deposition of hard carbonate scale on ﬁlter sand and distribution piping. Therefore, carbon dioxide in sufﬁcient quantity is often added to the water to bring the pH down to the range of 8.4 to 8.6 [40]. 2. Ion Exchange Ion exchange with synthetic resins is generally applied in circumstances where mineral quality of the product water necessitates a treatment more powerful than conventional ones. An ion exchanger is typically comprised of a bed packed with resin beads presaturated with exchangeable ions. Ion exchange media need to be reactivated with a regenerant solution and rinsed with water in preparation for another treatment cycle [41]. D. Disinfection The purpose of disinfection is to reduce the total bacterial concentration and eliminate the pathogenic bacteria in water. Potable water supply requires zero or very low bacterial concentration to avoid disease transmission. The total number of coliform groups of organisms, instead of the presence of speciﬁc pathogens, is often used as an indicator for sanitary quality and the efﬁciency of disinfection. There are many chemical disinfectants and physical methods that can be used for disinfection. 1. Chemical Disinfectant Addition of the chemical disinfectant to water provides a maximal time of contact between the chemical and organisms, assuring efﬁcient bactericidal action. A variety of chemical © 2003 by Marcel Dekker, Inc.

disinfectants is available for use in water treatment. Chlorine, iodine, bromine, quaternary ammonium, and ozone are examples. Chlorine, as gaseous chlorine or solid compounds such as calcium or sodium hypochlorite, is the most common chemical used for disinfection due to low cost, high efﬁciency, and ease of application. Prechlorination, or source water chlorination, is designed to minimize operational problems associated with biological slime formation on ﬁlters, pipes, and tanks and to lessen potential taste and odor problems as well. Postchlorination, or terminal disinfection, is the primary exercise for microbial reduction in product water. Addition of chlorine either immediately before the clear well or immediately before the sand ﬁlter is most common [42]. 2. Ultraviolet Radiation Ultraviolet (UV) radiation at a wavelength of approximately 254 nm is an effective biocide and provides no residual for distribution. The inactivation of microorganisms upon exposure to UV is based on the speciﬁc deleterious changes in nucleic acid. Yip and Konosewich [43] suggested that the dose of UV to kill pathogens is more comparable to the dose necessary to kill indicator bacteria than in the case of chlorine. Thus, the UV levels necessary to meet coliform standards may be relatively more effective than chlorination in killing pathogens. However, UV has not been widely used due to its inability to control bioﬁlm formation in distribution systems [44] and high operation cost. Ultraviolet disinfection is generally more practical for smaller-capacity usage because of the capital and operating expense necessary to ensure adequate water contact with lamp surface. An effective cleaning program must be established to ensure that biological and/or chemical foulants do not block UV transmission into the water. E.

Desalination

Conversion of saline water can be experimentally approached from either of two directions: (1) removal of salts from water by ion exchange or electrodialysis or (2) the removal of pure water from the raw liquid through unit operations such as vaporization (distillation), crystallization (freezing concentration), or membrane processes (reverse osmosis). The main desalination methods used in industry are distillation and membrane processes. Multistage ﬂash distillation (MSF) and RO have been found to be cost effective [11]. Multistage ﬂash has an extra advantage of the cogeneration of electricity. V.

WATER DISTRIBUTION SYSTEM

The purpose of a water distribution system is to deliver water in adequate quantity and acceptable quality in its application. The system includes water pumps, pipes, hoses, connections, other appurtenances, water transport vehicles, and reservoirs. Water contamination is a serious threat to the food industry. There has to be a system in place to ensure the use of safe potable water in food production and processing continuously. Where nonmunicipal water supply and sewage disposal are utilized, the location of these facilities shall be noted on the factory construction plans, and certiﬁcation of compliance with state and local regulations shall be acquired. The pumping and storage capacities, as well as the frequency of testing, of a nonmunicipal water supply must be speciﬁed. All sewage including liquid waste shall be disposed by a public sewage system or by a sewage disposal system constructed and operated following local laws and located for easy cleaning. © 2003 by Marcel Dekker, Inc.

A. Reservoir A reservoir that is used to supply water to a device such as a produce fogger shall be maintained in accordance with manufacturer’s speciﬁcations and cleaned in accordance with manufacturer’s speciﬁcations or according to the procedures speciﬁed in the FDA’s Food Code, whichever is more stringent [19]. The reservoirs of product water should be covered whenever possible to avoid recontamination from bird excrement, air contaminants, and surface water runoff. The water should be visually examined for color and clarity and checked for ﬂavor and odor before it is pumped into the holding tank [2]. Reuse water storage vessels, if used, should be properly constructed of material that will not contaminate the water and should allow for periodic cleaning. B. Plumbing Systems A plumbing system refers to a receptacle or device that is permanently or temporarily connected to the water distribution system of the premises. It is assembled of water supply and distribution pipes, traps, vent pipes, sanitary and storm sewers, and building drains. Plumbing systems and hoses conveying water must be made of approved materials, which are smooth, durable, nonabsorbent, and corrosion resistant, sized and installed according to applicable codes. The piping of any nonpotable water system shall be durably identiﬁed and distinguishable from differently colored piping that carries potable water. There shall be no cross-connections between potable water supply and any nonpotable or questionable water supply. Filters, screens, and other water conditioning devices; backﬂow prevention devices; and legal air gaps are sometimes installed in the plumbing system to prevent contamination of clean water with potentially contaminated water.

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12. Wasserwirtschaftliche Erhebungen (IX D). (German) Statistisches Bundesamt, 1995. 13. V Mavrov, A Fa¨hnrich, H Chmiel. Treatment of low-contaminated waste water from the food industry to produce water of drinking quality for reuse. Desalination 113:197–203, 1997. 14. K Leclair, M Heggart, M Oggel, FM Barlett, RC McKellar. Modeling the inactivation of Listeria monocytogenes and Salmonella typhimurium in simulated eggwash water. J Food Microbiol 11:345–353, 1995. 15. MP Palnitkar, RF McFeeters. Recycling spent brines in cucumber fermentations. J Food Sci 40:1311–1315, 1975. 16. TM Lin, JW Park, MT Morrissey. Recovered protein and reconditioned water from surimi processing waste. J Food Sci 42:953–957, 1995. 17. LD Reina, HP Fleming, EG Humphries. Microbiological control of cucumber hydrocooling water with chlorine dioxide. J Food Prot 58:541–546, 1995. 18. CAC. Proposed draft guidelines for the hygienic reuse of processing water in food plants. Codex Alimentarius Commission, Rome, Oct. 23–28, 2000. 19. FDA. Food Code. Washington, DC: Department of Health and Human Services, 1999. 20. JA Bartz, A Kelman. Inoculation of potato tubers with Erwinia carotovora during simulated commercial washing and ﬂuming practices. Am Potato J 61(8):495–507, 1982. 21. CAC. Recommended international code of practice general principles of food hygiene. Codex Alimentarius Commission, Rome, 1997. 22. Bond, Straub. CRC Handbook of Environmental Control, Vol III: Water Supply and Treatment. Cleveland, OH: CRC Press, 1973, p 209. 23. J Alonso, W Canet, T Rodriguez, Thermal and calcium pretreatment affects texture, pectinesterase and pectin substances of frozen sweet cherries, J Food Sci 62:511–515, 1997. 24. SG Uzogara, ID Morton, JW Daniel. Effect of water hardness on cooking characteristics of cowpea (Vigna unguiculata L. Walp) seeds. Int J Food Sci Technol 27(1):49–55, 1992. 25. L Curtis. Pop art: designing soft drinks. Food Prod Design 7(10):41–67, 1998. 26. L Piculell, S Nilsson, P Muhrbeck. Effects of small amounts of kappa-carrageenan on the rheology of aqueous iota-carrageenan. Carbohydrate Polym 18(3):199–208, 1992. 27. IH Suffet, A Corado, D Chou, MJ McGuire, S Butterworth. AWWA taste and odor survey. J Am Water Works Assoc 88(4):168–180, 1996. 28. A Amirtharajah, CR O’Melia. Coagulation processes: destabilization, mixing, and ﬂocculation. In: FW Pontius ed. Water Quality and Treatment, 4th Ed. New York: McGraw-Hill, 1990, pp 269–365. 29. JL Cleasby. Filtration. In: FW Pontius, ed. Water Quality and Treatment, 4th Ed. New York: McGraw-Hill, 1990, pp 455–560. 30. H Oosterom, G Galjaard, MM Nederlof, JC Schippers. Feasibility of micro- and ultraﬁltration for the direct treatment of surface water: results of various pilot studies. Desalination 119: 275–276, 1998. 31. FA Abd El Aleem, KA Al-Sugair, MI Alshmad. Biofouling problems in membrane processes for water desalination and reuse in Saudi Arabia. Int Biodeter Biodegra 41:19–23, 1998. 32. WJ Conlon. Membrane processes. In: FW Pontius, ed. Water Quality and Treatment, 4th Ed. New York: McGraw-Hill, 1990, pp 709–746. 33. E Van de Wende, WG Characklis, DB Smith. Bioﬁlms and baterial drinking water quality. Water Res. 23:1313–1322, 1989. 34. JY Hu, ZS Wang, WJ NG, SL Ong. The effect of water treatment processes on the biological stability of potable water. Water Res 33(11):2587–2592, 1999. 35. WG Charackils. Microbial fouling and microbial fouling control. In: WG Characklis, KC Marshall, eds. Bioﬁlm. New York: John Wiley and Sons, 1990, pp 523–633. 36. NR Khatiwada, C Polprasert. Assessment of effective speciﬁc surface area for free water surface constructed wetlands. Water Sci Tech 40(3):83–89, 1999. 37. PL Gainey, TH Lord. Microbiology of Water and Sewage. Englewood Cliffs, NJ: PrenticeHall, 1952.

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38. DA Cornwell. Air stripping and aeration. In: FW Pontius, ed. Water Quality and Treatment, 4th Ed. New York: McGraw-Hill, 1990, pp 229–268. 39. VL Snoeyink. Adsorption of organic compounds. In: FW Pontius, ed. Water Quality and Treatment, 4th Ed. New York: McGraw-Hill, 1990, pp 781–875. 40. LD Beneﬁeld, JM Morgan. Chemical precipitation. In: FW Pontius, ed. Water Quality and Treatment, 4th Ed. New York: McGraw-Hill, 1990, pp 641–708. 41. DA Clifford. Ion exchange and inorganic adsorption. In: FW Pontius, ed. Water Quality and Treatment, 4th Ed. New York: McGraw-Hill, 1990, pp 561–639. 42. CH Haas. Disinfection. In: FW Pontius, ed. Water Quality and Treatment, 4th Ed. New York: McGraw-Hill, 1990, pp 877–932. 43. RW Yip, DE Konosewich. Ultraviolet sterilization of water; its potential and limitations. Water Poll Cont (Canada), June 14–18, 1972. 44. V Lund, D Hongve. Ultraviolet-irradiation water containing humic substances inhibits bacterial metabolism. Water Res 28:1111–1116, 1994.

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11 Water and HACCP Programs YU-PING WEI and JAMES SWI-BEA WU National Taiwan University, Taipei, Taiwan PHILIP CHENG-MING CHANG National Taiwan Ocean University, Keelung, Taiwan

I.

INTRODUCTION

Water is used to produce, process, and under certain conditions store food. Water is also used as an ingredient in many processed foods. Contaminants can ﬁnd their way into food products via water as a carrier. Therefore, the quality of water inﬂuences the quality of food greatly. Only potable water should be used in food handling, formulation, and processing, except for steam production, operations where water is not in contact with food, and in certain processes provided that direct contact between water and food does not constitute a hazard to safety, e.g., chilling with clean seawater [1]. Potable water should meet the speciﬁcations in World Health Organization (WHO) or U.S. Environmental Protection Agency (EPA) guidelines for drinking water quality. Some of the key values are listed in Table 1. Natural water must be properly treated to meet drinking water standards. Water can also be recontaminated during storage and distribution. It is necessary to implement a sanitation standard operating procedure for water management in every food processing plant. Control should be established to prevent contamination from water to food products. The hazard analysis and critical control point (HACCP) system is often applied for this purpose. II. WATER AS A HAZARD SOURCE There are three major sources of contaminants in water used in food plants: contaminants in water source; residues of additives or contaminants formed during water treatment, © 2003 by Marcel Dekker, Inc.

Table 1 Some Key Values for Drinking Water Guidelines Parameter Color point/color scale Turbidity, nephelometric turbidity unit (NTU) Total dissolved solids, mg/L pH Magnesium (as Mg), mg/L Sodium (as Na), mg/L Iron (as Fe), mg/L Manganese (as Mn), mg/L Chloride (as Cl), mg/L Fluoride (as F), mg/L Sulfate (as SO 4), mg/L Nitrate (as NO 3), mg/L Copper (as Cu), mg/L Cadmium (as Cd), mg/L Selenium (as Se), mg/L Mercury (as Hg), mg/L Arsenic (as As), mg/L Lead (as Pb), mg/L Zinc (as Zn), mg/L Chromium (as Cr), mg/L Cyanide (as CN), mg/L Aluminum, mg/L Boron, mg/L Alpha emitters, Bq/L Beta emitters, Bq/L Fecal coliform, counts/mL

WHO

EPA

15 5 1000 6.5–8.5 — 200 0.3 0.1 250 1.5 250 50 1.0 0.003 0.01 0.001 0.01 0.01 3 — 0.07 0.2 0.5 0.1 1.0 0

15 5 500 6.5–8.5 0.05 — 0.3 — 250 2.0 250 10 1.0 0.005 0.05 0.002 0.005 0.015 5 0.1 0.2 — — 0 0 0

Source: Adapted from Refs. 4 and 40.

storage, or distribution of drinking water [2]; and cross-contamination during processing especially in reused or recycled water [3]. Water for food processing should be routinely analyzed for its quality. The elements of the analysis of water are listed in Table 2. Many of the listed items are used as a sanitary index or a measure of potential hazards. A.

Chemical Hazards

Chemical components in drinking water to be assessed for health risk include inorganic and organic compounds, pesticides, disinfectants, and disinfectant byproducts [4]. Naturally occurring contaminants are predominantly inorganic compounds such as arsenic and manganese, which are derived from natural mineral formations. Organic compounds, like pesticides, disinfectants, and disinfectant byproducts are usually introduced by human activity [2]. Several of the inorganic contaminants have beneﬁcial as well as adverse effects. Trace elements like copper, iron, manganese, molybdenum, selenium, and zinc are examples. On the other hand, lead from lead piping and plumbing and nitrate from intensive agricultural activities are usually harmful [2]. © 2003 by Marcel Dekker, Inc.

Table 2 Elements of the Analysis of Water Water characteristics

Physical–chemical properties

Undesirable components

Toxic components

Scent Color Turbidity

PH Conductivity Chloride Sulfate Calcium Aluminum Hardness Dry residuum

Nitrate Nitrite Ammonia Oxidation Iron Magnesium Copper Zinc Phosphorus Suspended particles

Arsenic Cadmium Cyanide Chromium Mercury Nickel Lead Antimony Pesticides Aromatic hydrocarbons

Hazardous organisms Salmonella spp. Escherichia coli Pseudomonas aeruginosa Streptococcus D Coliforms Aerobic mesophiles

Pesticides can reach ground or surface water by leaching or run-off following normal agricultural practices or by accidental spills [5]. Conventional drinking water treatment cannot remove many of these agricultural chemicals adequately because it was not speciﬁcally designed for this purpose [2]. Disinfection of drinking water often involves the use of very reactive chemicals such as chlorine, which has been the most important disinfectant for decades, or ozone, which is becoming more popular now. These compounds may react with many organic micropollutants in drinking water and thus give rise to disinfection byproducts. Food products may be contaminated by disinfectants that are used in cleaning but not thoroughly removed afterward. Or they may be contaminated from cooling water if the water is not properly treated. The metals that came from piping, plumbing, and equipment may also contaminate food [6]. B. Biological Hazards Freshwater carries indigenous microorganisms, including bacteria, fungi, protozoa, and algae. A few among them are known to produce toxins and cause or transmit diseases. The pathogenic microorganisms include Salmonella spp., Vibrio cholerae, Shigella spp., Cryptosporidium parvum, Giardia lamblia, Cyclospora cayetanensis, Toxiplasma gondii, some strains of Escherichia coli, etc., and the viruses such as Norwalk and hepatitis A viruses [7]. Water in distribution system may be contaminated by pathogenic bacteria, fungi, yeasts, protozoa, etc., that come from back-siphonage or have grown in dead ends [8,9]. Iron bacteria, whose sheaths contain ferric hydroxide, may gum up an entire water supply and are difﬁcult to eliminate. Efﬁcient ﬁltration greatly reduces the microbial load, but ﬁlters themselves may sometimes be a source of bacterial contamination of the water. For instance, ﬁlters in the treatment of water for making soft drinks have occasionally been found to contribute large numbers of coliform bacteria [10,11]. The two main sources of bacteria in drinking water distribution systems are bacteria grown in and sheared from the bioﬁlm and those carried over from the water treatment process [9]. Water may be in contact with food products after heat treatment. The microbiological quality of this water, especially if the foods are ready-to-eat types, should not only be free from pathogens (like drinking water), but also be low in (if not free from) spoilage © 2003 by Marcel Dekker, Inc.

bacteria, such as Pseudomonas, Alcaligenes, and Flavobacterium [7]. This is particularly important for foods to be kept at low temperatures. When water is used as one of the ingredients or as a process aide, there will be certain speciﬁc microorganisms that deserve concern. Anaerobic gas formers may enter foods from soil-laden water. The gas-forming coliform bacteria may enter milk via cooling tank water and cause trouble in cheese making. Bacteria that cause ripeness of milk, e.g., Alcaligenes viscolactis and Enterobacter aerogenes, usually come from water, as do slime-forming species of Achromobacter, Alcaligenes, and Pseudomonas, which sometimes cause trouble in cottage cheese. Cannery cooling water often contains coliform and other spoilage bacteria that may enter canned foods during cooling through minute defects in the seams or seals of the cans. This water commonly is chlorinated, but there have been reports that chlorine-resistant ﬂora can build up over a certain time period. Insufﬁcient cooling could result in thermophilic spoilage; excessive cooling could result in postprocess contamination due to leakage of corroded cans. The bacterium causing the surface taint of butter, Pseudomonas putrefaciens, comes primarily from water. The bacterial ﬂora of crushed ice to be applied to ﬁsh or other foods consist mostly of Corynebacterium, Alcaligenes, Flavobacterium, Pseudomonas, and cocci [6]. The ice or water used for chilling products, such as chicken at the ﬁnal stage of processing, can be a source of cross-contamination of a large number of birds from a single bird contaminated with an enteric pathogen [12,13]. Similarly, the warm water used in defeathering chickens can be a source of thermoduric bacteria [7]. Furthermore, reuse of water to cool continuous loads of produce increases the risk of cross-contamination. For example, contaminated produce from a single container going through a cooling process may result in the build-up of pathogens over time in the cooling water supply [3]. C.

Physical Hazards

A suspended particle in water generates at least two types of problems: ﬁrst, it can carry bacteria adhered on its surface and protects them from disinfection [13a,14]; second, it contributes to the formation of loose deposits in reservoirs and pipework, which are resuspended into the water phase when a change occurs in the hydraulic properties of the system (direction, velocity, water hammer, etc.) [15]. In distributed water, the number of suspended particles is usually quite low [16]. The composition of loose deposits has been determined and shown varying proportions of iron and manganese oxides, sand, zinc ﬂoc, algae siliceous skeleton, detrital organic particles, and micropollutants [15,17,18]. Sand, stone, and dirt resulting from washing vegetable or fruit and debris from equipment corrosion or breakage are the most commonly found physical hazards in process water [19]. However, a properly designed water treatment procedure is usually sufﬁcient to remove or detect harmful physical materials by means of sedimentation, screening, centrifugation, or metal detection devices. Therefore, potential physical hazards presented in water are usually not signiﬁcant enough to be dealt with individually. III. WATER HAZARD MANAGEMENT The aim of water management is to develop and maintain healthy water systems that guarantee sustained use. Proper equipment design and software management is a good way to control water safety. Through built-in antipollution features and a user-friendly self-diagnostic software interface, ideal water treatment equipment can avoid unplanned © 2003 by Marcel Dekker, Inc.

contaminations to occur from careless human handling errors. Hardware itself can never be error-free. It depends on properly designed standard operation procedures and monitoring routines to prevent any error from happening. Water contaminants from various sources are discussed in the following sections. A. Water Source Food plants should have an easy access to water supplies in good quality and sufﬁcient quantity. Criteria for choosing water supply vary with the geographic location and cost considerations. Potable, underground, and surface water are three common water sources for food production. Each source has its own hazardous characteristics. Potable water, which has previously been treated to meet drinking water standards, does not need to go through further treatment for amending its quality except to be used in the production of some special products such as carbonated beverages, which usually requires the water to softer. The quantity of water available to a food plant depends on the capacity of piping systems and other variables such as water pressure or pipe leakage. Most food companies are equipped with their own water storage facilities for emergent needs [20]. When using underground water for food production, the supply is usually sufﬁcient, and large storage tanks are not needed. The quality of underground water is mainly determined by the location and the depth of the well. Underground water generally goes through some natural ﬁltration processes that result in less contaminants and higher mineral content. Intended use determines if a demineralization treatment is necessary. In recent years, the concern over the contamination from industrial dumps, agricultural pesticides, and human activities has limited the use of underground water without cautious puriﬁcation treatments followed by constant monitoring of the quality [21]. Surface water from rivers or lakes is the most convenient source of water, while at the same time the most unstable one in terms of the variation in quality and quantity, as affected by season, climate, and the environment. Because of the direct exposure of surface water to biological and chemical pollutants, hazards from this origin should be watched for carefully. Therefore, surface water should never come into contact with foods unless it has been adequately puriﬁed. The supply of water should be planned to meet the peak water demand of the food processing facility. In practice, two sets of parallel water treatment systems, or a set of a backup system in addition to the main system, are suggested to keep the supply of water uninterrupted while maintenance or repairing work is undertaken [20]. B. Water Treatment and Distribution Systems Though it is designed to remove impurities and safeguard the water supply, water treatment systems without proper maintenance can be a potential source of contamination [22,23]. Modern water treatment equipment also includes sensors, detectors, or controllers that continuously monitor the water quality. These automated devices can detect or control water pressure, water ﬂow velocity, alkalinity, as well as the residual disinfectant content in a piping system. In a computer-aided automatic water treatment system, accurate inline monitoring and controlling of water quality can be achieved and the chance for water safety failure from human error is greatly reduced. However, scheduling for inspection and maintenance service, including calibration of sensors, timers, or feeding pumps, becomes © 2003 by Marcel Dekker, Inc.

necessary to prevent the occurrence of failures of the system. Moreover, the person in charge should keep complete records of service and inspection. Plumbing systems and hoses conveying water should be made of approved corrosive-, alkaline-, and acid-resistant materials. Cross-connection between drinking water and non–drinking water systems should be prohibited. It is advisable that non–drinking water piping systems shall be durably identiﬁed to be readily distinguishable from drinking water systems. A backﬂow prevention design should be installed to prevent reverse contamination of water reservoirs or tanks from handwashing or service sinks. These devices include air gap or backﬂow (back-siphonage) prevention valves or altitude control design. Devices such as water treatment equipment or backﬂow preventers shall be scheduled for inspection and service in accordance with manufacturer’s instructions and as necessary to prevent device failure based on local water conditions. Routine inspection of microbial, alkalinity, and residual chlorine of the water supply is important. A routine microbial check of potable water every six months is normally adequate, but should be more frequent, such as once per month, for water from other sources. Alkalinity and residual chlorine are easier to be measured, and more frequent inspections are recommended [20]. C.

Water for Food Processing

Included in this category are washing water, rising water, chilling water, cooling water, etc. The required quality of water may vary depending on where along the chain of processes the water is used. While water quality management may vary throughout all operations, packers should follow good manufacturing practice (GMP) to minimize the potential for the introduction or spread of pathogens via processing water. Water that meets the microbial standards for drinking water is considered safe and sanitary. The use of chemical disinfectants ought to be in accordance with national or regional laws or regulations. Operators should carefully read antimicrobial chemical labels, regulations, and other relevant information. Operators should follow manufacturers’ directions for correct mixing of antimicrobial chemicals to obtain efﬁcient concentrations and to minimize safety hazards. Operators should not add antimicrobial chemicals in wash water to reach a concentration higher than the allowable level. Antimicrobial chemical levels should be routinely monitored and recorded to ensure that they are maintained at appropriate concentrations. Other parameters, such as pH, temperature, and oxidation–reduction potential, which indicate level of active agents or those factors affecting the effectiveness of the antimicrobial agents, should also be monitored and recorded. Surfactant treatments with some antimicrobial chemicals may need to be followed by a clean water rinse to remove any residues. If hot water is used for cleaning purposes, temperature should be monitored. Periodic changing or cleaning of screens and ﬁlter assembles is important to maintain sanitary conditions for the reconditioning of washing water. The beneﬁts of chilling to remove ﬁeld heat and the temperature requirements for optimal keeping quality vary for different types of produce. Maintaining temperatures that promote optimal product quality may reduce the risk of microbial hazards. Chilling equipment, such as hydrocoolers, and containers holding produce during chilling operations, should be clean and sanitary. Field soil should be removed as much as possible from produce and containers prior to chilling [24]. © 2003 by Marcel Dekker, Inc.

D. Reused or Recycled Water Washing water recycled for food product usage is generally not acceptable because of its highly polluted nature. If its utilization is inevitable, complete removal of impurities and pathogens by means of ﬁltration, disinfection, or heating is necessary. In any case, reused water should be subjected to reconditioning to meet certain microbiological as well as chemical and physical criteria on drinking water speciﬁcations before its use. It is recommended for the processor to adopt performance parameters for monitoring and testing programs to assure that the water is reconditioned and maintained free of pathogens. Appropriate performance parameters may include temperature control and microbiological tests. Visible solids should be removed before reuse. No sanitary nuisance should be allowed. Testing for total bacterial counts, total coliforms, fecal coliforms, coagulase, Staphylococcus aureus, Listeria monocytogenes, Legionella spp., and other related pathogens should be considered for validation purposes. Testing for chemical oxygen demand (COD) or similar tests may also be performed. During storage, there should be no microbiological carryover of reused water from one day to the next unless the temperature is maintained at or above 63°C (145°F) by automated means. The intended use of the water determines the chemical quality required. For instance, if the water is reused for disinfecting or cleaning, it should not contain substances in amounts that affect the efﬁciency. Recycled water should have a separate distribution system that is readily identiﬁable [25]. E.

Steam Supply

Steam coming into direct contact with food or food-contact surfaces should be generated from potable water with no harmful substances added. Steam supply should be sufﬁcient for operational requirements. The use of boiler treatment chemicals ought to be in accordance with national or regional laws or regulations. F.

Ice Supply

Ice as an ingredient or in direct contact with food should be made from potable water and be properly manufactured, handled, and stored to avoid contamination. Microbial testing of water for ice making ought to be performed periodically to ensure its clean and sanitary condition. If the ice is purchased from a supplier, the food plant operator should ask the supplier for information about the ice-making plant and the routine inspection records of this product. It is advisable to keep these records on ﬁle. Equipment for the manufacture, transportation, and storage of ice should be in sanitary condition. Water in hydrocoolers should be changed as needed to maintain the quality. Interiors of hydrocoolers should routinely be cleaned and sanitized [20]. IV. CONTROL OF WATER HAZARDS A. Critical Control Point As mentioned, water used for culinary purposes or in direct contact with food materials should meet drinking water standards. As a common practice in the food industry, the quality of processing water is constantly monitored and controlled by sanitation standard operation procedure (SSOP) or GMP programs. An operation that may affect the shelf© 2003 by Marcel Dekker, Inc.

life of a food product is regarded as a critical control point (CCP). Water may be involved at a CCP either by acting as the means for reducing the microbial load of a raw material in such treatments as washing or cleaning in the processing for fresh or minimum processed foods or by acting as a heat exchange medium in contact with an in-process or ﬁnal product. The water used in these instances should receive especially stringent quality control. Examples are the washing water in the processing of fresh-cut vegetables, fruits, poultry, and red meat [26–29] and the cooling water in canneries [30]. B.

Critical Control Limits

Critical control limits are set to distinguish between safe and unsafe operating conditions at a CCP and should not be confused with operational limits that are established for reasons other than food safety. The commonly used control factors with critical limits for processing water to meet are as follows: 1.

2.

3.

4.

5.

6.

Total bacterial count. Total bacterial count proved to be the most practical and sensitive indicator of the removal and inactivation of microorganisms in individual processes [31]. Total coliform bacteria. Coliform bacteria are used as indicators of microbial contamination of drinking water because they are easily detected and found in the digestive tract of warm-blooded animals. While not all of them are disease producers, they are often found in association with other microbes that are capable of causing disease. Coliform bacteria are more tolerant to adverse environments than many disease-causing organisms; therefore, their absence from water indicates bacteriological safety for human beings [31]. Fecal coliform (mostly E. coli). Fecal coliform constitutes a portion of the coliform bacteria group. They are originated in the intestinal tract of warmblooded animals and passed into the environment in feces. Fecal coliform is often used as an indicator of the fecal contamination of domestic water supply [32]. Coagulase test. A positive response indicates that Staphylococcus aureus, Listeria monocytogenes, Legionella spp., and some other related pathogens should be taken into consideration. Temperature. In many food processing operations the optimal temperature is decided by more than one single factor. Besides the reduction of the risk of microbial hazards, the maintenance of other quality attributes should also be considered. Take the wash water temperature, for example. Rodriguez de Ledesma et al. [33] used hot water (95°C) for the decontamination of poultry skin and found a signiﬁcant reduction in the microﬂora. However, cold water at 5°C, instead of hot water, should be used to wash fresh-cut vegetables to optimize the produce quality [27]. Antimicrobial chemicals. The effectiveness of antimicrobial agents depends on their chemical and physical states, treatment conditions (water temperature, acidity, and contact time), and the resistance of pathogens [34]. Chlorine, for example, is commonly added to water to maintain a concentration of 50–200 ppm, at a pH of 6.0–7.5, with contact time of 1–2 min for post-harvest treatments of fresh produce. Ozone has been used to sanitize wash and ﬂume water in packing house operations. Ultraviolet radiation may also be used to disinfect processing water [26]. Chlorine dioxide, trisodium phosphate, and organic acids

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(such as lactic and acetic acids) have been studied for use as antimicrobial agents in produce wash water [35]. Operators should investigate available options of water sanitation and choose the most appropriate one for their individual operations. 7. pH. Adjusting the pH of processing water down to a certain level may be an effective safeguard against many pathogens. However, when hypochlorites are used as the antimicrobial agent, the reduction in pH may be offset by the increased self-decomposition of these chemicals [36]. 8. Contact time or ﬂow rate. The effectiveness of a cleaning or cooling operation is affected by contact time [37]. The ﬂow rate of processing water is usually a convenient measure of the contact time. 9. Pressure. When a pressure wash is used, critical control limits on the pressure should be set and monitored. Critical control limits must be based on scientiﬁc knowledge. It is not unusual to implement more than one criterion of food safety at a single CCP. C. Corrective Actions When water quality deviates out of control limits, suitable corrective actions must be undertaken in order to re-establish control as quickly as possible. These actions must be planned in advance and should be able to determine and correct the cause of noncompliance. The product produced during the period of the deviation must be held and tested for acceptability for human consumption before it is released to the market. Corrective actions for water quality deviation include adjusting pH, temperature, ﬂow rate, recycled water mixture ratio, and chlorine addition and may involve turning on the backup water treatment system to keep the normal process operation uninterrupted. When the deviation persists, discontinuation of the production is required for identiﬁcation of the possible causes. It is essential to record the whole event, including the actions taken to correct the deviation, the identiﬁcation of deviant lots, and the actions taken to ensure the safety of these lots. These records must remain on ﬁle for a reasonable period after the expiration date or expected shelf-life of the product. D. Veriﬁcations According to the Codex Alimentarius [38], veriﬁcation of CCP is the application of methods, procedures, tests, and other evaluations, in addition to monitoring, to determine compliance with the HACCP plan. The ﬁrst phase of the process is the scientiﬁc or technical veriﬁcation to prove that critical limits at CCPs are satisfactory. The critical limits of water quality are usually set by laws or regulations [39]. There is no need for factory operators to verify the scientiﬁc basis of these limits. The second phase of veriﬁcation is to assure the effectiveness of the HACCP plan. The actions include evaluating the execution of water management procedure, reviewing the CCP records, and determining whether appropriate risk management decisions and product dispositions are made when deviations occur. Supervisors should be appointed to carry out periodical cross-checks among the records of CCPs, disinfectant consumption, maintenance expenses, and utility bills to validate the accuracy. The most recent sample report for the water analysis should be retained on ﬁle in the food processing plant. The third phase of veriﬁcation consists of revalidations, independent auditing, and/or other procedures to ensure the performance of the HACCP © 2003 by Marcel Dekker, Inc.

plan. The water safety management plan should be discussed, and if necessary amended, according to the frequency of water quality deviation, a shift in quantity and quality of water supply and demand, and any changes of the HACCP plan that affect the water supply mechanism of the food plant. REFERENCES 1. CAC. Recommended International Code of Practice—General Principles of Food Hygiene. Rome: Codex Alimentarius Commission, 1999. 2. FXR Van Leeuwen. Safe drinking water: the toxicologist’s approach. Food Chem Toxicol 38: S51–S58, 2000. 3. SA Palumbo, KT Rajkowski, A Miller. Current approaches for recondition process water and its use in food manufacturing operations. Trends Food Sci Technol 8:69–74, 1997. 4. WHO. Guidelines for Drinking-Water Quality, 2nd Ed.: Health Criteria and Other Supportive Information. Addendum to Vol. 2. Geneva, Switzerland: World Health Organization. 5. JK Fawell. British Crop Protection Council Monograph No. 47, 1991, p 205. 6. WC Frazier, DC Westhoff. Food Microbiology. New York: McGraw-Hill, 1988, pp 63–64. 7. B Ray. Fundamental Food Microbiology. Boca Raton, FL: CRC Press, 1996, pp 369–376. 8. BH Olson, LA Nagy. Microbiology of potable water. Adv Appl Microbiol 30:73–132, 1984. 9. S Fass, ML Dincher, DJ Reasoner, D Gatel, JC Block. Fate of Escherichia coli experimentally injected in a drinking water distribution pilot system. Water Res 30(9):2215–2221, 1996. 10. E Van de Wende, WG Characklis, DB Smith. Bioﬁlms and bacterial drinking water quality. Water Res 23:1313–1322, 1989. 11. I Sibille, L Mathieu, JL Paquin, D Gatel, JC Block. Microbial characteristics of a distribution system fed with nanoﬁltered drinking water. Water Res 31(9):2318–2326, 1997. 12. GC Mead. Food poisoning samlonellas in the poultry-meat industry. Br Food J 92:32–36, 1990. 13. RWAW Mulder. Concentrating on hygiene and environment control. Misset-World Poultry 10:41–45, 1994. 13a. HF Ridgway, BH Olson. Chlorine resistance patterns of bacteria from two drinking water distribution systems. Appl Environ Microbiol 44(4):972–987, 1982. 14. DS Herson, B McGonogle, MA Payer, KH Baker. Attachment as a factor in the protection of Enterobacter cloacae from chlorination. Appl Environ Microbiol 53(5):1178–1180, 1987. 15. V Gauthier, B Gerard, JM Portal, JC Block, D Gatel. Organic matter as loose deposits in a drinking water distribution system. Water Res 33(4):1014–1026, 1999. 16. BJ Brazos, JT O’Connor. Seasonal effects on the generation of particle-associated bacteria during distribution. Proceedings of the Water Quality Technology Conference, American Water Works Association, 1990 San Diego, CA: AWWA, pp 1073–1101. 17. HF Ridgway, BH Olson. Scanning electron microscope evidence for bacterial colonization of a drinking water distribution system. Appl Environ Microbiol 41(1):274–287, 1981. 18. LI Sly, MC Hodgkinson, V Arunpairojana. Deposition of manganese in a drinking water distribution system. Appl Environ Microbiol 56(3):628–639, 1990. 19. A Fahnrich, V Mavrov, H Chmiel. Membrane processes for water reuse in the food industry. Desalination 119:213–216, 1998. 20. FDA. Food Code. Washington, DC: Department of Health and Human Services, 1999. 21. CL Hamann, JB McEwen, AG Myers. Guide to selection of water treatment process. In: FW Pontius, ed. Water Quality and Treatment, 4th Ed. New York: McGraw-Hill, 1990, pp 157– 187. 22. MW Lechevallier, TM Babcock, RG Lee. Examination and characterization of distribution system bioﬁlms. Appl Environ Microbiol 53:2714–2714, 1987. 23. V Lund, K Ormerod. The inﬂuence of disinfection processes on bioﬁlm formation in water distribution systems. Water Res 29(4):1013–1021, 1995.

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24. CFASN. Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables. Washington, DC: U.S. Department of Health and Human Services, 1998. 25. CAC. Proposed Draft Guidelines for Hygienic Reuse of Processing Water in Food Plants. Rome: Codex Alimentarius Commission, October 23–28, 2000. 26. JS Dickson, ME Anderson. Microbiological decontamination of food animal carcasses by washing and sanitizing systems: a review. J Food Prot 55:133–140, 1992. 27. ME Guerzoni, A Gianotti, MR Corbo. Shelf-life modeling for fresh-cut vegetables. Postharvest Biol Technol 9:195–207, 1996. 28. KC Ong, JN Cash, MJ Zabik, M Siddiq, AL Jone. Chlorine and ozone washes for pesticide removal from apples and processed apple sauce. Food Chem 55(2):153–160, 1996. 28a. SL Kochevar, JN Sofos, SB LeValley, GC Smith. Effect of water temperature, pressure and chemical solution on removal of fecal material and bacteria from lamb adipose tissue by spraywashing. Meat Sci 45:377–388, 1997. 29. PJ Delaquis, S Stewart, PMA Toivonen, AL Moyls. Effect of warm, chlorinated water on the microbial ﬂora of shredded iceberg lettuce. Food Res Int 32:7–14, 1999. 30. PJ Thompson, MA Grifﬁth. Identity of mesophilic anaerobic sporeformers cultured from recycled cannery cooling water. J Food Prot 46(5):400–402, 1983. 31. WOK Grabow. Microbiology of drinking water treatment: reclaimed wastewater. In: GA McFeters ed. Drinking Water Microbiology. New York: Springer-Verlag, 1990. pp 187–195. 32. EJ Fricker, CR Fricker. Alternative approaches to the detection of Escheriachia coli and coliforms in water. Microbiol Europe 2:16–20, 1996. 33. AM Rodriguez de Ledesma, HP Rieman, TB Farver. Short time treatment with alkali and/or hot water to remove common pathogenic and spoilage bacteria from chicken wing skin. J Food Prot 59:105–112, 1996. 34. NM Bolder. Decontamination of meat and poultry carcasses. Trends Food Sci 8:221–227, 1997. 35. P Van Netten, JH Huis In’t Veld, DAA Mossel. The effect of lactic acid decontamination on the microﬂora on meat. J Food Safety 14:243–257, 1994. 36. SJ Weber, WW Levine. Factors affecting germicidal efﬁciency of chlorine and chloramines. Am J Public Health 32:719–722, 1994. 37. E Bessems. The effect of practical conditions on the efﬁciacy of disinfectants. Int Biodeter Biodegrad 41:177–183, 1998. 38. CAC. Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for Its Application. Rome: Codex Alimentarius Commission, 1997. 39. EPA. Drinking Water Standards and Health Advisories. Washington, DC: U.S. Environmental Protection Agency, 2000.

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12 Water Use in the Beverage Industry DANIEL W. BENA PepsiCo Beverages International, Purchase, New York, U.S.A.

I.

INTRODUCTION

One part in 1,000,000,000,000,000 parts! Believe it or not, analytic measurements down to this detection level (parts per quadrillion) are quickly becoming routine for certain classes of organic compounds (e.g., the polychlorinated dibenzo-dioxins and -furans). With the lightning-fast progress being made by chemists, physicists, and other scientists we can only expect this trend to continue. Consequently, everyone involved with water in the food and beverage industries—either as an ingredient, product, or process chemical—will be forced to learn more about this often complex matrix, from its origin through the paths it travels and the contaminants it meets along the way to the point where it enters the production facility. Water brings with it an inconceivable number of potential components—some considered contaminants, others considered therapeutic, and still others considered essential for life. The treatment technologist’s challenge then becomes determining which components should be retained (and how), which should be reduced (and how)—and what the consequences of this selection might be. These consequences could potentially range from a minor, aesthetic defect in ﬁnished product to a beverage or food product which results in widespread public illness. The seriousness of a thorough understanding of water treatment is a unifying principle throughout this chapter. Over the past ﬁve years, the beverage industry’s usable technology focus has moved from coagulation, ion exchange, ﬁltration, carbon adsorption, and ultraviolet disinfection to the use of membranes in technologies ranging from reverse osmosis, nanoﬁltration, ultraﬁltration, and microﬁltration; continuous electrodeionization; electrodialysis; selective exchangers; and sophisticated controls and automation. Our quality focus has expanded to include organics, inorganics, and pathogens that are serious health concerns © 2003 by Marcel Dekker, Inc.

and present new treatment obstacles and detection capability at a level to defy imagination, which promises tighter and tighter regulatory guidelines. Our business focus is now largely driven and supported by regulatory guidelines and compliance requirements that demand in-house programs and reporting protocols. Over the next few years, millions of dollars will be spent on replacing or upgrading existing water treatment equipment or technology to keep pace with these new challenges. It will be a transition period of substantial turbulence, and we intend to offer insights into the advantages and shortcomings of all technology to aid the water technologist in making the best decisions for a given water supply. II. WATER SOURCES Perhaps the best place to begin a discussion of water sources is with an initial reference to the hydrologic cycle. As its name implies, the hydrologic cycle describes the continuous movement of water throughout its phases of state (solid, liquid, and vapor) within our hydrosphere; it is pictorially summarized in Fig. 1. This ‘‘movement,’’ or transformation, can be imagined in ﬁve major steps [1]: 1.

Figure 1

Water moving from the earth to the sky. In this part of the cycle, the movement of water from the earth to the sky involves a combination of three pathways: (1) evaporation, where water absorbs solar radiation which allows its transformation from water liquid to water vapor; (2) transpiration, where water is released to the atmosphere by plants as part of their normal physiological processes; and (3) sublimation, where water (in its solid state as ice and snow) passes directly to the vapor state. The ﬁrst two pathways are often combined and referred to simply as evapotranspiration.

The hydrologic cycle. (Courtesy Hamele-Bena, 2001.)

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2. Water vapor forming water liquid. The active pathway in this step of the hydrologic cycle is one of condensation, due to temperature gradients within the atmosphere. Water vapor, which ‘‘moved from earth to sky,’’ and which is then stored in cloud formations, begins to form small droplets of water and/or small crystals of ice. As this condensing water continues to form to eventually ‘‘saturate’’ the sky, the next step is imminent. 3. Water falling back to earth, in the form of snow, ice, rain, sleet, and hail. The hydrologic cycle may be compared, on a much smaller and simpliﬁed scale, to a laboratory distillation. The aqueous sample in the ‘‘pot’’ is forced to move from liquid to vapor state, then the vapor is forced to condense back to liquid, and this puriﬁed liquid falls back to a collecting vessel. Ironically, despite the constant recycling of water through the hydrologic cycle, Table 1 illustrates that it may not be as pure as you think! These data, though reprinted in 1990 [2], were originally collected decades ago. A comparable analysis using today’s environment and current analytic methodology would be interesting; unfortunately, it is likely that the table would need to be expanded, especially to include parameters such as the result of acid precipitation, industrial discharge to the atmosphere, and emerging pathogens. 4. Water penetrating the ground. A single pathway describes this movement of water downward through the soil, but it is generally divided into two components. There is Inﬁltration, where water soaks into the soil and moves toward the root zones of area plant life. As part of the cycle, this water is then incorporated by the plants and eventually reintroduced via transpirative processes. Percolation describes a similar movement of water through the soil, but generally to greater depths—past the root zones and toward the aquifers, or water-bearing geological strata, which will be discussed in more detail in the next sections. It is this movement of water through the soil that represents a ‘‘double-edged sword.’’ On one hand, inﬁltration provides a perfect opportunity for the water to become contaminated on its journey—from underground storage tanks, septic systems, naturally occurring contaminants, and other sources. On the other hand, it also provides one of the most effective attenuative mechanisms for many Table 1

Chemical Analyses of Rain, Snow, and Hail

Parameter (ppm) Total hardness, as CaCO3 Calcium hardness Magnesium hardness Alkalinity Sodium Ammonia Chloride Sulfate Nitrate Iron Silica Source: Adapted from Ref. 2.

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Rain after 4 hr

Rain after 22 hr

Snow

Hail

43 42 1 19 5 1.5 7 26 1 0.9 0.15

8 8 11 5 0.11 2 4 3 — 0.1 0.15

18 14 4 — 5 6 12 21 1 1.2 3

28 25 3 4 — 1 7 17 — 2.4 1

5.

contaminants. That is, through complex ion-exchange, adsorptive, and microbiological processes in the soil, contaminants may be reduced in concentration or completely transformed chemically into some other compound before reaching many ground water supplies. Water returning to the oceans. This explains the pathway of surface runoff. The soil becomes ‘‘saturated’’ (this term is used loosely here, since saturated and unsaturated zones have very speciﬁc meanings to hydrogeologists) and ﬂows downhill (piezometrically, and usually downhill topographically, but not always) over the surface and near the surface. The moving water can incorporate anything in its path including physical debris, chemical contaminants, and microorganisms as it moves toward the rivers, streams, etc., and on back to the oceans, where it again joins the evapotranspirative section of the hydrologic cycle.

Since this effect is cyclical, it may be entered at any point along its route, and followed through to some endpoint. Though the hydrologic cycle is often viewed as basic and fundamental, it does underscore the conservative and recyclable nature of these processes. As a result, the quality and safety of the water used in our products and processes is, to some extent, directly linked to how that water supply traverses the hydrologic cycle, and with which contaminants and impurities it comes in contact. Our knowledge of the basic and allied sciences is ever increasing, and the importance of water quality and overall water resources management increases in direct response. Now, the toxicological and other health-related impacts of our ingredient water are under more study than ever before. As the skills of the analytic chemist lead to ever-decreasing lower limits of detection, the chemicophysical and microbiological integrity of our water supplies will be under more scrutiny and of greater importance than at any other time in history. This chapter addresses the selection, treatment, and safety of this dynamic ingredient as used in the beverage industry. As an introduction, Table 2 affords an overall view of the world’s water distribution [3]. These numbers will vary depending on which source and what year of publication are cited. The overall illustration, however, is the same. The key things to glean from the

Table 2 Estimated World Water Balance Parameter

Surface area (km2 ⫻ 10⫺6 )

Volume Volume Equivalent (km3 ⫻ 10⫺6 ) (%) depth (m)

Oceans and seas Lakes and reservoirs Swamps River channels Soil moisture Ground water

361 1.55 ⬍0.1 ⬍0.1 130 130

1370 0.13 ⬍0.01 ⬍0.01 0.07 60

94 ⬍0.01 ⬍0.01 ⬍0.01 ⬍0.01 4

Icecaps and glaciers

17.8

30

2

Atmospheric water Biospheric water

504 ⬍0.1

Source: Adapted from Ref. 3.

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0.01 ⬍0.01

⬍0.01 ⬍0.01

2500 0.25 0.007 0.003 0.13 120 60 0.025 0.001

Residence time ⬃4000 years ⬃10 years 1 to 10 years ⬃2 weeks 2 weeks to 1 year 2 weeks to 10,000 years 10 to 10,000 years ⬃10 days ⬃1 week

table are these: (1) the vast majority of the world’s water is trapped in the oceans, which are not yet considered economically feasible as useable drinking water supplies on a large scale; (2) if we remove the oceans from consideration and we remove the water trapped in glaciers and the polar ice caps, only one to ﬁve percent of the world’s water (depending on the source cited) is considered treatable for use; and (3) of this small percentage, the vast majority of the supply (in some cases close to 100 %) is found in the form of ground water. Unfortunately, the citation of available water, alone, does not automatically mean that these supplies are accessible or safe. According to D. A. Okun [4], in 1980 nearly 2 billion people did not have access to water supply and sanitation services. In 1990 it was estimated that more than 2.7 billion people in developing countries lacked access to these basic services (1.7 billion without access to sanitation, over 1 billion without access to water). Ten years later at the ﬁrst World Water Conference, held at the Hague, a full 20% of the global population was cited as being without access to safe drinking water [5]. Many feel that even these numbers are grossly underestimated due to the classiﬁcation of exactly what water supply and sanitation ‘‘services’’ mean. As a country’s geographic region, economic standing, and political infrastructure vary, so do the extent of what is acceptable in the provision of water supplies. Since we now know that the overall supply of water is a ﬁnite entity, let us examine the different water sources from which we may select our supply. A. Water Sources Water sources may be classiﬁed into two major categories, ground water and surface water. Ground water examples include consolidated and unconsolidated aquifers (discussed later), artesian supplies, springs, etc., in short, water supplies that invade the saturated zone of the subsurface environment. Surface water examples include reservoirs, oceans, lakes, rivers, etc. The two categories differ greatly in the characteristics of the water they supply, as does water from groups even within the same category. Surface waters are usually higher in suspended solids, color, and turbidity than ground waters and lower in total dissolved solids. The temperature of ground waters (depending on depth) is remarkably consistent—sometimes within a few degrees per year; in contrast, surface supplies, subject to the sun’s radiation, are remarkably variable in temperature. As far as ﬂow characteristics, surface waters are usually turbulent, while ground waters are usually laminar. Typical ﬂows for some ground water supplies may be one meter per day, in contrast to some surface waters that ﬂow one meter per second. Due to this wide variability, the often asked question ‘‘what does a typical surface water look like in terms of its chemistry?’’ is impossible to answer with certainty. The best we can do is provide generalities, with the condition that there are truly exceptions to every rule. Table 3 has been compiled by the author to present a relative comparison of surface and ground water supplies. Just when you think you have a thorough understanding of a particular supply, tread carefully; you may not! 1. Surface Water Supplies In general, surface supplies can be highly variable in every respect—chemically (total dissolved solids, alkalinity, etc.), microbiologically (bacteria, viruses, etc.), and physically (turbidity, color, etc.). Many surface waters are easily subject to contamination which may present in many forms, including (1) bacteria and other organisms from animal wastes © 2003 by Marcel Dekker, Inc.

Table 3 Relative Comparison of Ground and Surface Supplies Parameter Total dissolved solids Suspended solids Turbidity and color Alkalinity Total organic carbon Microbiology Protection from bacteria and viruses Protection from protozoa Presence of iron and/or manganese bacteria Hydrogen sulﬁde gas Aeration/dissolved oxygen Temperature Flow rate Flow pattern Susceptibility to pollution through surface runoff Time for a contaminant plume to resolve

Ground water

Surface water

Higher Lower Lower Higher Lower

Lower Higher Higher Lower Higher

Highly protected

Highly susceptible

Almost completely protected Common

Highly susceptible Rare

Common Lower More consistent Very slow (1 m/day) Laminar Low

Uncommon Higher More variable Very fast (1 m/sec) Turbulent High

Very long—often decades, potentially centuries

Usually short—days/months, sometimes years

via direct introduction (animals) or indirect introduction (poorly or untreated wastewater); (2) algae blooms, which are typically acute, seasonal events; (3) ‘‘natural’’ chemical contamination as evidenced by high levels of natural organic matter (primarily the humic substances from decaying vegetation and animal waste); and (4) ‘‘synthetic’’ chemical contamination from surface runoff (outﬂow) of agricultural chemicals (pesticides, herbicides, insecticides, etc.). Again, it must be underscored that the preceding characteristics, and those that follow, are intended to provide general trends in terms of water composition and characteristics. During the author’s industrial tenure, exceptions to virtually every characteristic described have been observed. a. Streams. In general, streams are often of reasonable chemical/physical composition. Due to their locations and physical dimensions, they offer easy access for a multitude of animal life. With this comes the frequent introduction of microorganisms of fecal origin, in addition to appreciable amounts of organic matter. This organic material is typically considered the precursor material of trihalomethanes and a host of other chemical byproducts which can be formed once this water supply is disinfected. Smaller streams are often inﬂuenced by rain events, whereby their ﬂows are increased, with subsequent increase in suspended solids and turbidity. Larger streams are generally at higher risk of having industrial waste (often poorly or inadequately treated) discharged into them. They are often more of a concern, due in part to their larger surface area, in terms of accepting surface runoff and subsurface drainage. b. Lakes. Natural lakes, due to their relatively stagnant ﬂow patterns, coupled with their long water residence time, are usually of consistent composition insofar as surface supplies are concerned. One major climatic event which may have drastic changes in lake © 2003 by Marcel Dekker, Inc.

water quality is the phenomenon of seasonal inversion. This refers to the phenomenon whereby water at the surface of the lake reaches a temperature at which it is most dense (3.98°C, or 39.2°F). The water below it has not yet reached this state; therefore, density and temperature gradients are formed. This ‘‘heavy’’ water then begins to descend, and displaces the water below it. This displaced water then inverts and moves from the bottom of the lake toward the upper portion. This agitation brings with it much of the sediment and associated unwanted components, which make municipal and industrial monitoring even more critical during this time. As you might imagine, this phenomenon of inversion and its related thermal stratiﬁcation are actually much more complex, and their effects on aquatic life and the eutrophication process (basically, the nutrient enrichment of a body of water, usually lakes or ponds, which results in growth of certain forms of algae and some higher plant life) have been studied under many other scientiﬁc disciplines. Unfortunately, as is the case with many large streams, industrial waste efﬂuent and sewage treatment plant discharge are often reintroduced into the same lake that originally supplied the inﬂuent water. These practices are coming under more scrutiny, and there is ever increasing political pressure for regulatory reform. c. Reservoirs. Impounding reservoirs, or manmade lakes, are similar in overall characteristics to those described for natural lakes. They are often regarded as huge storage reservoirs for municipal water supplies prior to treatment. As surface supplies go, reservoirs are of fairly consistent quality, of reasonable turbidity (due in large part to natural oxidation and settling mechanisms), and often afford lower bacteria counts than other surface supplies [6]. However, as a consequence of their relatively low ﬂow patterns and lack of agitation, algae blooms are often a problem. d. Rivers. Rivers represent perhaps the most difﬁcult of the surface supplies to address. In general, they are of highly inconsistent quality, have very high turbidity and suspended solids, are prone to considerable temperature ﬂuctuations, and vary widely with respect to their ﬂow patterns (that is, areas of excessive turbulence and areas of minimal movement may exist within close proximity). Rivers, as a result of their great length and ﬂows, are recipients of surface runoff from many types of areas. For example, a river might ﬂow across areas of agrarian activity, with the potential to incorporate pesticides, herbicides, nitrate, and other contaminants along its route. This same river might later ﬂow through an industrial zone, pick up runoff from poorly contained chemical storage tanks, drains, sewers, etc., and possibly even meet the discharge of one or more municipal waste treatment plants. Imagine the contaminant ‘‘soup’’ that would result. For this reason, any methods of treatment for river water must be preceded by thorough characterization of the supply. The treatment itself must be capable of addressing a wide range of quickly changing water quality. 2. Ground Water Supplies In comparison to surface supplies, ground water supplies are generally more consistent in every respect—thermally, microbially, chemically, and physically. They have historically been considered a much safer supply, or one which produces ‘‘purer’’ water. Two hundred years ago this blanket statement might have been more universally true. Along with the development of the chemical and related industries came the increased potential for ground water contamination. Prior to this, the concerns over ground water were few— maybe the well was dug a little too close to the septic tank or cess pool, and incidences of diarrhea and other gastrointestinal ailments were increasing (so digging another one © 2003 by Marcel Dekker, Inc.

farther away or a little deeper were the apparent solutions). Possibly the well was under the inﬂuence of a salt water or brackish supply, and intrusion of high levels of salts were becoming evident (usually noticed by taste). In many cases, the two former solutions would have applied here as well. Though this example is a gross oversimpliﬁcation, the facts remain that with increasing industry came increasing underground chemical storage, increasing contaminant spills, increasing numbers of poorly located and/or poorly constructed septic systems, along with a host of other problems for the ground water environment that needed to be addressed (and, in fact, many still do). As with surface water supplies, there are different classiﬁcations of ground water— some more preferred than others. A brief discussion of each, in terms understood by the novice hydrogeologist (which is a discipline becoming increasingly important for anyone involved with water operations), follows. a. Aquifers and the Underground Environment. An aquifer is deﬁned as ‘‘a geologic formation with sufﬁcient interconnected porosity and permeability to store and transmit signiﬁcant quantities of water under natural hydraulic gradients’’ [7]. Critical terms in this description are store, transmit, and signiﬁcant quantities. All three should be satisﬁed to consider a supply an aquifer. The ﬁrst two are straightforward—huge amounts may be stored, but unable to be transmitted, in which case this supply, however large, should not be considered an aquifer. The third term is more nebulous and linked to the intended use of the supply, e.g., a residential well, a large municipality, or multiple industrial users tapped into a community well. Clearly, ‘‘signiﬁcant quantities’’ would be deﬁned differently for these three applications. Before discussing aquifers in more detail, Fig. 2 should be reviewed. It describes the different layers or zones encountered as we move downward from the surface of the ground to the water-bearing strata below it. As we move from the surface, the ﬁrst zone encountered is the unsaturated zone (also referred to as the vadose zone). In this area, the geologic media (dirt, clay, sand, etc.) contains a mixture of water and void spaces with air, hence the terms unsaturated or variably saturated. Continuing downward, we reach the capillary fringe, which is gen-

Figure 2

The underground environment. (From Ref. 35.)

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erally considered the beginning of the saturated zone, but is sometimes considered a distinct entity. This interface between unsaturated and saturated zones is not completely understood and is the subject of much study with regard to movement of certain contaminants within it. The saturated zone is the area where air is at a minimum and water is at a maximum. The geologic media here are saturated with water. Dissolved oxygen in the saturated zone is extremely rare; many deep ground water formations exist under anaerobic or hypoxic conditions. It is within the saturated zone where actual ground water supplies are found and where most production wells are placed. Throughout the saturated zone, many strata of varying permeability will be found. Most importantly, this is where we ﬁnd our aquifers. b. Unconﬁned and Conﬁned Aquifers. Aquifers may be grouped into two broad categories: unconﬁned aquifers and conﬁned aquifers. Unconﬁned aquifers (sometimes referred to as water table aquifers) are those water-bearing, geologic formations which are under atmospheric pressure at their upper boundary. The water table (sometimes referred to as the phreatic surface) is the upper boundary of the saturated zone. Water levels in wells which tap unconﬁned aquifers should be the same as the level of the water table. The plane that connects the upper levels of water in all wells which penetrate unconﬁned aquifers is known as the potentiometric surface. Conﬁned aquifers (sometimes called artesian aquifers) are those water-bearing, geologic formations whose upper and lower boundaries are comprised of geologic material of low permeability and which are under pressure greater than atmospheric. Older deﬁnitions may describe the boundary layers (or conﬁning layers) of a conﬁned aquifer as being of no permeability (that is, impermeable). This is inaccurate, as even the least permeable geologic materials still exhibit some degree of permeability. Some hydrogeologists further classify these conﬁning layers accordingly, as aquitards, aquicludes, and aquifuges. While all three exhibit very low permeabilities, aquitards are the most permeable of the three, followed by aquicludes, and ﬁnally aquifuges, which are as close to impermeable as we know. Conﬁned aquifers are sometimes further described as semiconﬁned (also partially conﬁned, or leaky conﬁned) or highly conﬁned (also fully conﬁned), depending on the leakage or seepage through the conﬁning layers. Just as the water in unconﬁned aquifers will form a potentiometric surface, or water table plane, the water levels in wells tapping conﬁned aquifers will also form a plane. It may still be referred to as a potentiometric surface, but, intuitively, not a water table plane. In the case of conﬁned aquifers, due to the internal pressures, the water levels in wells which tap them may often exceed the level of the water table (which may result in a ﬂowing artesian well). In the beverage industry, conversational knowledge of conﬁned and unconﬁned aquifers will account for nearly all of the hydrogeologic discussions into which a beverage technologist might become engaged. For purposes of completeness, two more topics will be brieﬂy addressed. In addition to aquifers being classiﬁed as conﬁned or unconﬁned, the geologic material of the aquifer may be described as consolidated or unconsolidated. Unconsolidated deposits are formed from loose geologic material, such as sand, clay, silt, gravel, and even sea shell remains. Consolidated deposits are formed by mineral particles combining from heat and pressure, or via chemical mechanisms. They include sedimentary (previously unconsolidated) rocks, such as limestone, dolomite, shale, and sandstone; igneous (formed from molten) rocks, such as granite and basalt; and metamorphic rocks, such as limestone and gneiss [8]. Fractured rock formations almost always refer to fractures or ﬁssures in © 2003 by Marcel Dekker, Inc.

consolidated deposits. Ground water and contaminant ﬂows through this type of formation are highly unpredictable, since it is difﬁcult to determine which route the water will take through this hard rock maze. Carbonate aquifers (also karstic formations) are formations of limestone and other water-soluble rocks whose fractures have been widened by erosion to form sinkholes, caves, or tunnels [9]. As you might expect, with such little resistance the ﬂows through fractured and carbonate formations can be rapid enough to rival surface water sources. Flows up to 1500 feet per day, though rare, have been reported. B.

Source Selection Considerations

The categories mentioned brieﬂy discussed the major sources of supplies for potable water. Obviously, there are others (oceans, lagoons, glaciers, etc.) and many possible combinations of supplies. Remember, the keys to any consideration of a water source are as follows: 1.

2.

3.

4.

5.

6.

First and foremost, sanitary quality, wherever possible. In some areas of the world, the potability of a supply—even a municipal supply—may not be guaranteed. Chemical/physical quality. Is it safe? Is it too high a risk to even consider? Can it be treated economically and within regulatory guidelines? These questions must be answered on a case-by-case basis and will depend on the degree of due diligence desired by a parent company, presiding regulations, corporate policies, and the risk assessment of the impurities themselves. Consistency of composition. Is it consistent? Will it vary beyond the capability of the proposed treatment? Gathering any and all available data will aid in answering this question. Make use of municipal monitoring data, rainfall data, hydrogeologic or surface water surveys, etc. Volume/supply. Can it currently meet your needs? Will it in the future? In addition to the quality and safety components, supply is a key parameter to help ensure that the volume of water will be available for the long-term needs of the business. In many areas, the volume of withdrawal of water from an aquifer falls under government control or guidance, and this must be considered. Recharge. Is runoff a concern? This is related to the previous discussion of the hydrologic cycle. The volume of recharge, or replenishment, of the aquifer is important, as is the quality and origin of the water being used for that recharge. Future plans for the source or surrounding areas is a municipality planning to develop the source and treat it? Are there multiple taps? Is there planned construction or industrial entry to the area? These questions highlight the value of considering water a dynamic ingredient throughout its supply chain. Many beverage plant issues have resulted from municipal water treatment plant operators effecting a change to the municipal treatment without alerting the beverage plant personnel. For example, if polyphosphate use is instituted by a municipality for corrosion control within its distribution system, this could result in a gross upset to the ﬂoc formation in conventional lime treatment systems.

Water, unlike virtually any other raw material, often does not provide an opportunity for sourcing from an alternative supplier. Consequently, selection of a source after thorough characterization is paramount, and subsequent treatment design is critical to helping assure that only a safe, consistent, high quality treated water is used by food and beverage plants. © 2003 by Marcel Dekker, Inc.

C. Speciﬁcations and Guidelines Frankly, in the Unites States, Canada, the European Union, and most other ﬁrst world countries, the expectations for water treatment are clearly delineated by the regulatory agency having jurisdiction. That is, drinking water must meet the National Primary Drinking Water Standards [10,11] promulgated by the U.S. Environmental Protection Agency (EPA), the Directive of the European Union (EU) on the Quality of Water Intended for Human Consumption [12], or some analogous drinking water standard. Indeed, many of these standards are founded, to varying degree, on the Guidelines for Drinking Water Quality established by the World Health Organization (WHO) [13,14]. Packaged water, or the water used to make carbonated beverages, usually have corresponding regulations. In the United States, for example, the Food and Drug Administration (FDA) established a bottled water standard of identity, which, with only a few exceptions, mirrors the EPA’s Drinking Water Standards. The challenges come when we establish our beverage businesses in second and third world countries where the regulatory standards are perhaps not as reﬁned as for those countries mentioned previously. In these countries, the beverage producer is not afforded the luxury of knowing that the water entering their plant will consistently meet U.S. EPA drinking water standards or the EU standards for water intended for human consumption. In these situations, it becomes even more critical that rigorous water source assessment, careful treatment selection, and conscientious long-term monitoring are performed with even greater diligence. Table 4 was compiled by the author for informational purposes only to compare the major standards for drinking water around the globe. The National Primary Drinking Water Standards of the EPA are compared to the EU Standards for Water Intended for Human Consumption, and ﬁnally with the Guidelines for Drinking Water Quality of the World Health Organization. For a beverage producer, as is likely the case with any of our food industry allies, we cannot—and should not—rely on any external body to assure the quality and consistency we require for the production of our trademark products. Certainly, a conscientious municipal monitoring scheme established by the EPA or analogous regulatory organization often increases our conﬁdence that a particular water supply will reach our plant with some level of safety and consistency, but this should not be expected; rather, it should be viewed as an added beneﬁt to complement our already-dependable in-plant treatment system. III. WATER TREATMENT A. Goals of Treatment In light of the mounting scientiﬁc evidence for the myriad chemical compounds related to their adverse health effects—at a time when the terms carcinogen, mutagen, and teratogen are practically becoming part of the vernacular—the primary reason for water treatment is to safeguard public health and safety. All other reasons for treatment are secondary, and include the following: 1. To assure compliance with all levels of regulatory guidelines and mandates. The product water for carbonated soft drinks has historically had to meet not only the primary drinking water standards of the Environmental Protection © 2003 by Marcel Dekker, Inc.

Table 4

Comparison of Major Drinking Water Standards and Guidelines

Parameter Inorganic constituents (mg/L, unless otherwise noted) Aluminum Ammonia Alimony Arsenic Asbestos Barium Beryllium Boron Cadmium Calcium Chloride Chromium Copper Cyanide Fluoride Hydrogen sulﬁde Iron Lead Magnesium Manganese Mercury (total) Molybdenum Nickel Nitrate (as NO 3 )

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WHO health

WHO aesthetics

USEPA 1a MCL health

0.2 1.5 0.005P 0.01P U 0.7 NAD 0.5P 0.003

0.006 0.05 (interim) 7 MFL (⬎10 µ) 2 0.004

0.05 0.3 0.01

0.5P 0.001 0.07 0.02P 50

0.2 0.5 (ammonium)

1 0.005 250

0.1 (total) 1.3 (action level) 0.2 (as free) 4

1 2

250 0.05 2 0.05 1.5

0.3 0.015 (action level)

0.1

EU indicator parameters

0.005 0.01

0.005

1

EU

0.05–0.2

250 0.05P 2P 0.07 1.5

USEPA 2b MCL aesthetics

0.2 0.01

0.05

0.05

0.002 (inorganic)

0.001

0.1 10 (as N)

0.02 50

Nitrite (as NO 2 ) Nitrate/nitrite Potassium Selenium Silver Sodium Sulfate Thallium Tin Zinc Organic constituents (µg/L) Chlorinated alkanes Carbon tetrachloride 1,1-Dichloroethane 1,2-Dichloroethane 1,2-Dichloromethane 1,2-Dichloropropane 1,1,1-Trichloroethane 1,1,2-Trichloroethane Chlorinated ethenes (or ethylenes) 1,1-Dichloroethene 1,2-Dichloroethene Trichloroethene Tetrachloroethene Vinyl chloride

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3P (acute); 0.2P (chronic) Sum of [conc: GV] ⱕ1

1 (as N)

0.5

10, total (as N)

0.01 U

0.05

0.01 0.1

200 250

500P 0.002

200 250

250

U 3

2 NAD 30 20 2000P

30 50 70P 40 5

5

5 5 5 5 200 5

7 70 (cis) 100 (trans) 5 5 2

3

10 total 0.5

Table 4

Continued

Parameter Aromatic hydrocarbons Benzene Benzo(a)pyrene Ethylbenzene Fluoranthene Phenols Polycyclic aromatic hydrocarbons (PAHs), as sum of Benzo(g hi) perylene, benzo(b) ﬂuoranthene, benzo (k)ﬂuoranthene, indeno(1,2,3-cd)pyrene Styrene Toluene Xylenes (o, m, and p) Chlorinated benzenes Monochlorobenzene 1,2-Dichlorobenzene 1,3-Dichlorobenzene 1,4-Dichlorobenzene 1,2,4-Trichlorobenzene Trichlorobenzenes (total)

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WHO health 10 0.7 300 U

WHO aesthetics

USEPA 1a MCL health

2–200

5 0.2 700

USEPA 2b MCL aesthetics

EU 1 0.01

0.1

20 700 500

4–2600 24–170 20–1800

100 1000 10,000 total

300 1000 NAD 300

10–120 1–10

100 600

0.3–30

75 70

20

5–50

EU indicator parameters

Miscellaneous organics Acrylamide Dialkyltins Di(2-ethylhexyl)adipate Di(2-ethylhexyl)phthalate Edetic acid (EDTA) Epichlorohydrin Hexachlorobutadiene Microcystin-LR cyanobacterial toxin Nitrilotriacetic acid Polychlorinated biphenyls (PCBs), as decachlorobiphenyl Tributyltin oxide Pesticides (µg/L) Total pesticides Alachlor Aldicarb Aldicarb sulfone Aldicarb sulfoxide Aldrin/dieldrin Atrazine Bentazone Carbofuran Chlordane 4-Chloro-2-methylphenoxy acetic acid (MCPA) Chlorotoluron Cyanazine Dalapon

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0.5 NAD 80 8 600 0.4P 0.6 1P

TT

0.1

400 6 TT

0.1

200 0.5

2

20 10

0.03 2 300 7 0.2 2

2 3 2 4 3 40 2

30 0.6 200

0.5 (and 0.1 each) 0.1 0.1 0.1 0.1 0.03 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1

Table 4

Continued

Parameter 1,2-Dibromo-3-chloropropane (DBCP) 1,2-Dibromoethane Dichlorodiphenyl trichloroethane (DDT) 2,4-Dichlorophenoxyacetic acid (2,4-D) 1,2-Dichloropropane 1,3-Dichloropropane 1,3-Dichloropropene Dinoseb Diquat Dioxin (2,3,7,8-TCDD) Endothall Endrin Ethylene Dibromide Glyphosate Heptachlor Heptachlor epoxide Hexachlorobenzene Hexachlorocyclopentadiene Isoproturon Lindane Methoxychlor

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WHO health 1

WHO aesthetics

USEPA 1a MCL health 0.2

0.4–15P 2

USEPA 2b MCL aesthetics

EU 0.1 0.1 0.1

30

70

0.1

40P NAD 20

5

7 20 0.00003 100 2 0.05

0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1

700 0.4 0.2

0.1 0.03 0.03

1 50

0.1 0.1 0.1 0.1 0.1

10P

NAD U 0.03 Total of Both 1 9 2 20

0.2 40

EU indicator parameters

4(2-Methyl-4-chlorophenoxy) butyric acid (MCPB) Metolachlor Molinate Oxamyl (vydate) Pendimethalin Pentachlorophenol Permethrin Picloram Propanil Pyridate Simazine Terbuthylazine Toxaphene Triﬂuralin Chlorphenoxy herbicides other than 2,4-D and MCPA 4(2,4-Dichlorophenoxy) butyric acid (2,4-DB) Dichlorprop Fenoprop Mecoprop Silvex (2,4,5-TP) 2,4,5-Trichlorophenoxyacetic acid (2,4,5-T) Disinfectants and disinfection byproducts (D-DBPs) (µg/L) Bromate Monochloramine

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NAD

0.1

10 6

20

0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1

90

0.1

100 9 10

0.1 0.1 0.1 0.1 0.1

200 20 9P 20

1 500

20 100 2 7

4 3

50 9

25P 3000

100

10

Table 4

Continued

Parameter Chloral hydrate (trichloroacetal dehyde) Chloramines (total) Chlorate Chlorine Chlorine dioxide Chlorite Chloroacetone 3-Chloro-4-dichloromethyl5-hydroxy-2(5H)furanone (MX) Chloropicrin Cyanogen chloride (as CN) Dichloramine Formaldehyde Trichloramine Other disinfectants Chlorophenols 2-Chlorophenol 2,4-Dichlorophenol 2,4,6-Trichlorophenol Halogenated acetic acids Monochloroacetic acid Dichloroacetic acid Trichloroacetic acid Haloacetic acids (HAA5), includes mono-,di-, and trichloroacetic acid and mono- and dibromoacetic acid)

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WHO health

WHO aesthetics

USEPA 1a MCL health

10P 4000 MRDL NAD 5000

600–1000

200P NAD NAD

4000 MRDL 800 MRDL 1000

NAD 70 NAD 900 NAD

NAD NAD 200

0.1–10 0.3–40 2–300

NAD 50P 100P 60 total

USEPA 2b MCL aesthetics

EU

EU indicator parameters

Halogenated acetonitriles Bromochloroacetonitrile Dibromoacetonitrile Dichloroacetonitrile Trichloroacetonitrile Trihalomethanes (THMs) Bromodichloromethane Bromoform Chloroform Dibromochloromethane Total THMs Other chemical/physical parameters Color

NAD 100P 90P 1P 60 100 200 100 Sum of [conc: GV] ⱕ1

80

15 TCU

15 Co-Pt

Acceptable

Noncorrosive 0.5 mg/L TON ⫽ 3

Conductivity Corrosivity Foaming agents Odor Oxidizability pH

Taste Total dissolved solids (TDS) Total organic carbon (TOC) Turbidity

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100

⬍8 for effective disinfection w/chlorine acceptable

6.5–8.5

Acceptable to customers and no abnormal change 2500 µS/cm @20°C

Acceptable to consumers and no abnormal change 5 mg/L O 2 ⱖ6.5 and ⱕ9.5

Acceptable to consumers and no abnormal change

1000 mg/L

500 mg/L No abnormal change

5 NTU

TT

Acceptable to consumers and no abnormal change

Table 4

Continued WHO health

Parameter Radiologic constituents Alpha activity, gross

Beta activity, gross Combined radium-226 and radium-228 Radium-226 Radium-228 Radon Total indicative dose Tritium Uranium Microbiologic constituents All water intended for drinking Clostridium perfringens (including spores) Colony count @22°C Cryptosporidium E. coli or thermotolerant coliform bacteria Enterococci Giardia lamblia

0.1 Bq/L

1 Bq/L

WHO aesthetics

USEPA 1a MCL health

USEPA 2b MCL aesthetics

EU

EU indicator parameters

15 pCi/L (includes Ra-226; excludes radon and uranium) 4 mRem/year 5 pCi/L 200P pCi/L 20P pCi/L 300P pCi/L 0.1 mSv/year 100 Bq/L

0.002P mg/L

0.02P mg/L

0/100 mL No abnormal change 0/100 mL

Legionella Heterotrophic plate count Total coliform bacteria Total plate count @35°C Viruses

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TT (MCLG ⫽ 0) ⬍5% samples positive

0/100 mL 0/100 mL

TT (99.9% reduction) TT TT (500 cfu/mL) 0/100 mL TT (99.99% reduction)

Water for sale in bottles or containers E. coli Enterococci Pseudomonas aeruginosa Colony count @22°C Colony count @37°C a

0/250 mL 0/250 mL 0/250 mL 100/mL 20/mL

1° refers to the primary maximum contaminant levels (MCL) established by the EPA, which are enforceable limits. 2° refers to the secondary maximum contaminant levels (SMCL) established by the EPA, which are generally not enforceable on a federal level. Notes: Blank cells indicate the absence of a standard for that parameter. Chemicals that have been assigned a ‘‘provisional guideline’’ value by WHO, or a ‘‘proposed MCL’’ by USEPA, are followed by the letter P. Chemicals listed by WHO as ‘‘not of health signiﬁcance at concentrations normally found in drinking water’’ are designated with the letter U. Chemicals evaluated by WHO and assigned the status of having ‘‘no adequate data to permit recommendation of a health-based guideline value are designated with the letters NAD. In most cases, standard IUPAC chemical nomenclature was applied, so the unsaturated alkene family of compounds will end in the sufﬁx -ene. Be aware that some regulatory agencies continue to use the older common names, which bear the sufﬁx -ylene. So, for example, trichloroethene and trichloroethylene are identical. MCLG: maximum contaminant level goal GV: guideline value, a maximum level recommended by WHO for the provision of safe drinking water MRDL: maximum residual disinfectant level, established by the EPA TT: treatment technique, an approach developed by EPA to provide direction to municipalities as to which parameters require installation of an acceptable treatment technique to demonstrate reduction of the respective contaminant(s) MFL: million ﬁbers per liter, an established measure of asbestos levels TCU: total color units Co-Pt: cobalt platinum color units NTU: nephelometric turbidity units TON: threshold odor number µS/cm: microsiemens per centimeter, a standard expression of conductivity mSv/year: milliSievert per year, a standard expression of committed effective dose of radiation pCi/L: picoCurie per liter, the U.S. expression of the activity of ionizing radiation Bq/L: Becquerel per liter, the Standard International (SI) system of expressing activity for ionizing radiation (1 Curie ⫽ 3.7 ⫻ 1010 Becquerel and 1 pCi ⫽ 10⫺12 Ci; therefore pCi/L ⫻ 0.037 ⫽ Bq/L) mrem/year: milliroentgen equivalent man per year, the U.S. expression of radiation dose; applies to total body and individual organ exposure, calculated on the basis of a 2 L/ day drinking water intake Source: From Refs. 10–14. b

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2.

Agency (in the United States), but all applicable local standards as well. This same philosophy of multiple levels of compliance holds true as we look at the international arena as well. Here, compliance will be driven not only by national standards (often founded to a varying degree on the World Health Organization Guidelines for Drinking Water), but also by local (state, regional, etc.) regulations and codes germane to each product category (bottled water, natural mineral waters, juice drinks, teas, etc.) To achieve speciﬁc product characteristics and improve product shelf-life. Certain soft drink products require ingredient water of varying composition. By utilizing a variety of water treatment unit operations, the requisite composition can be achieved (e.g., ion exchange demineralization for those products sensitive to the proﬁle of dissolved ionic solids). In addition, the shelf-life of the individual product is often prolonged by removal of troublesome components that could potentially result in aesthetically displeasing precipitation (e.g., preventing the precipitation of calcium oxalate salts in tea by limiting the incoming calcium load).

As mentioned, the wide range of chemicophysical characteristics required of our ingredient water mandates the utilization of a variety of water treatment technology. Selection of the appropriate treatment chain is based upon several factors, including but not limited to (1) water source—aquifer and watershed characteristics, municipal supply/consistency, location, etc.; (2) proposed technology capability relative to raw water analyses and desired product characteristics—removal of organics, inorganics, disinfection/inactivation, color and odor control, etc.; (3) recommended support technology—ﬁltration, preozonation, iron/manganese removal, etc.; (4) costs versus ﬁnished water proﬁle—initial investment, operating costs, equipment serviceability/parts accessibility, etc.; and (5) contribution to plant efﬂuent—total dissolved solids, water volume to drain, etc. Where ingredient water for production of soft drinks is concerned, the typical ‘‘ﬂeet’’ of treatment technology available to the beverage industry includes 1.

2.

3.

Conventional lime treatment systems (CLTS)—coagulation/ﬂocculation, hydrated lime, superchlorination. This treatment chain represents the majority of most beverage treatment armadas worldwide. Historically, and as little as twenty-ﬁve years ago, this combination of treatment was regarded as the ideal treatment for raw water of virtually any quality. Indeed, this system, coupled with the required support technology—ﬁne sand ﬁltration, granular activated carbon, polishing ﬁltration, and ultraviolet irradiation—does address a broad range of water contaminants. Ion exchange. This technology is routinely utilized for partial or complete demineralization, softening, dealkalization or can be customized for selective removal of a speciﬁc contaminant (e.g., denitratization). Membrane technology. Clearly, this has seen the most growth in recent years with the advent of more resistant membrane materials of construction and more ﬂexible rejection characteristics. Included in this category is the prototype of the cross-ﬂow, polymeric membrane ﬁltration systems—reverse osmosis, along with nanoﬁltration and ultraﬁltration (both polymeric and ceramic). Also among this group is electrodialysis technology for removal of ionic species in water and continuous electrodeionization.

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B. Primary Treatment Technology 1. Conventional Lime Treatment Systems Conventional lime treatment systems, sometimes also referred to as traditional coagulation or the cold lime process, remains one of the most common treatment techniques employed in the carbonated beverage industry. Five years ago, one estimate placed approximately 85% of beverage water systems using conventional lime treatment (personal communication, Harry Delonge, 1996), but this number has been steadily decreasing over the years, with this treatment modality being replaced by membrane systems. Operationally, at its most fundamental level CLTS involves mixing three chemicals—a chlorine source, a coagulant, and hydrated lime—together in a reaction tank and allowing a contact time of at least two hours for the ensuing reactions to proceed. The hydrated lime (traditionally called ‘‘lime’’ even though calcium oxide is rarely used) increases the pH of the water in the reaction tank to above 9.6, thereby converting the naturally occurring bicarbonate alkalinity components to carbonate alkalinity. This is a critical reaction since at this pH, calcium carbonate is virtually insoluble in water and begins to precipitate from solution. At the same time, the coagulant, aided by steady, nonturbulent mixing, is overcoming the repulsive negative charges present on natural organic debris in the water supply. This charge neutralization and subsequent destabilization allows the coagulant to form a ﬂoc of ever-increasing size and density. As it forms, it incorporates the precipitating calcium carbonate, along with a host of other particulates present in the incoming water. The chlorine source in conventional systems serves a dual purpose: (1) oxidation—both of the soluble ferrous sulfate coagulant to the insoluble ferric form and of metallic contaminants like iron, manganese, arsenic, and others and (2) disinfection of the water in the reaction tank. The efﬁciency of disinfection in these systems will be discussed in more detail at a later point in this chapter. However, at high pH values (typically the range used in CLTS), the dissociated chlorine equilibrium favors the existence of the hypochlorite anion, which is approximately 100 times less effective as a germicide than the dominant species at lower pH (hypochlorous acid). From a microbial safety perspective, if the adequate free chlorine dosage is maintained in the reaction tank over the entire course of the two-hour contact time, this will afford excellent bacterial and viral destruction. The protozoans, like Cryptosporidium and Giardia, being more resilient to chlorine, will be less affected by the chlorine at the high pH employed in conventional lime treatment systems. However, the chlorine, aided by the physical entrapment and removal of these organisms during the coagulation process, will still typically result in a substantial reduction in their numbers. Indeed, conventional coagulation is one of the effective barriers in a multiple barrier approach against protozoans. This ﬂoc that forms over the course of the two-hour reaction time in conventional systems continues to grow in size and bulk, enmeshing suspended solids, particulates, oxidized metals, organic debris, and a host of other impurities, and eventually settles toward the bottom of the reaction tank. The settled ﬂoc comprises the ‘‘sludge’’ associated with these conventional lime treatment systems, which must be frequently discharged in order to keep this system in equilibrium. As the impurity-laden ﬂoc is discharged from the bottom of the reaction tank, the treated water—now free of debris, low in alkalinity, sanitized, and of a generally high quality—is withdrawn from the top of the reaction tank to undergo further treatment through support processes prior to being used for ﬁnal product. Table 5 summarizes the advantages and disadvantages of these treatment systems. From a water safety perspective, conventional lime treatment continues to offer excellent © 2003 by Marcel Dekker, Inc.

Table 5 Advantages and Disadvantages of Conventional Lime Treatment Systems Advantages

Disadvantages

Removes alkalinity and hardness Removes organic debris, particulates, and natural organic matter (NOM) Reduces metal concentrations (iron, manganese, arsenic, others) and some radionuclides Reduces some color compounds (tannins), offtastes, and off-odors Reduces bacteria, virus, and protozoan populations

Does not effectively reduce nitrate, sulfate, or chloride concentration Sludge formation and disposal requirements May promote the formation of disinfection byproducts (trihalomethanes) under certain conditions Often difﬁcult to operate consistently in waters with very low dissolved solids Relatively large space requirements on plant ﬂoor (footprint)

removal of a variety of water impurities. It is often adequate as a primary treatment for many beverage water puriﬁcation applications, but may also be used as a superb pretreatment for membrane processes, ion exchange, or electrodialysis. 2. Membrane Technology Membrane technology, in the application of water treatment for the beverage industry, encompasses a broad range of polymeric and ceramic impurity removal techniques. This may range from the use of a simple 10-µm microﬁlter to help remove granular activated carbon ﬁnes to employment of the prototype polymeric membrane technology, reverse osmosis. Figure 3 depicts the ﬁltration spectrum, which provides a visual representation of the relative particle size removal which may be expected of the common membrane processes, including—in order of decreasing pore size—microﬁltration, ultraﬁltration, nanoﬁltration, and reverse osmosis. As we can see from the spectrum, particulate ﬁlters may be used for the removal of relatively large suspended matter and are often employed at the end of a water treatment chain as a ‘‘polishing ﬁlter’’ to remove any small ﬂoc particles, oxidized iron, carbon, or precipitated calcium carbonate that might have carried over from the primary treatment process. Microﬁlters are often used for their controlled pore size distribution (when absolute rated), which makes mechanical removal of bacteria from water streams commonplace. Often for this application a stepped removal approach is

Figure 3

The ﬁltration spectrum.

© 2003 by Marcel Dekker, Inc.

employed which will include ﬁlters of decreasing pore size oriented in series, so as to minimize the plugging potential of the smallest pores (e.g., a 5- or 10 µm particulate ﬁlter, followed by a 0.45-µm microﬁlter, and ﬁnally as low as a 0.2-µm ﬁlter to help assure adequate bacterial reduction). Ultraﬁltration (either polymeric or ceramic) is an excellent tool for the removal of particulates, large organic matter (e.g., the humic and fulvic acids which comprise natural organic matter in water supplies), and many types of microorganisms, including viruses, bacteria, and protozoa. However, for removal at the level of dissolved inorganic salts, nanoﬁltration and reverse osmosis are our only two feasible options. Table 6 compares the typical removal percentages of reverse osmosis, nanoﬁltration, and ultraﬁltration for a variety of water impurities [15]. The driving force behind the membranes used in water treatment applications for the beverage industry is pressure, which is applied across the membrane to force the ﬁltered or puriﬁed water through the membrane, leaving the unwanted impurities behind. This concept becomes even more critical when describing the operation of a reverse osmosis membrane system. To understand reverse osmosis, we must ﬁrst understand osmosis. According to The Drinking Water Dictionary [16], osmosis is a ‘‘natural phenomenon whereby water (or some other solvent) diffuses from the lower-concentration side to the higher-concentration side of a permselective (semipermeable) membrane barrier in a process of equalizing concentrations on both sides.’’ The corresponding osmotic pressure is the pressure exerted on the solution at equilibrium as a result of osmosis. This is illustrated in Fig. 4. In reverse osmosis, we apply a pressure to the concentrated side that is greater than the osmotic pressure, which thereby reverses the osmotic ﬂow . The result is that the water now ﬂows across the reverse osmosis membrane in the opposite direction to what was just described with osmosis. The water is forced from areas of high to low solute concentration, thereby leaving a very concentrated salt stream behind on the waste side of the membrane and a very dilute, puriﬁed water stream on the product or permeate side of the membrane.

Table 6 Comparison of Reverse Osmosis, Nanoﬁltration and Ultraﬁltration Membrane Processes Component

Reverse osmosis

Nanoﬁltration

Ultraﬁltration

Alkalinity TDS Particulates Organic matter THM precursors Sodium Chloride Hardness Sulfate Nitrate Protozoa Bacteria Viruses Operating pressure

95 to 98% 95 to 98% Near 100% Most ⬎100 MW 90⫹% 90 to 99% 90 to 99% 90 to 99% 90 to 99% 90 to 95% Near 100% Near 100% Near 100% 200 to 450 psi

50 to 70% 50 to 70% Near 100% Most ⬎200 MW 90⫹% 35 to 75% 35 to 60% 50 to 95⫹% 70 to 95⫹% 20 to 35% Near 100% Near 100% Near 100% 100 to 200 psi

None None Near 100% Some ⬎2000 MW 30 to 60% None None None None None Near 100% Near 100% Near 100% 80 to 150 psi

Note: Approximate removal percentages; actual performance is system speciﬁc. Source: Adapted from Ref. 15.

© 2003 by Marcel Dekker, Inc.

Figure 4

Osmosis. (From Ref. 36.)

This is depicted in Fig. 5. This is an important concept to visualize, since it is this osmotic pressure control which allows reverse osmosis to remove impurities from water down to the level of dissolved ionic species. In fact, reverse osmosis can afford removal of from 95 to greater than 99% of many dissolved salts, resulting in a treated water exiting the system with a total dissolved solids (TDS) concentration often below 10 mg/L, within the range of many distilled water products. Though ultraﬁltration, nanoﬁltration, and reverse osmosis all afford efﬁcient removal of many microbial impurities, a critical point which must be understood is that none of these processes—not even reverse osmosis—produces a commercially sterile water. This is still a common misconception among many in the beverage and allied industries. Owing to the nature of cross-ﬂow technology, the high pressures used, integrity of the seals, and variability in the pore structure of the membrane materials, these membrane treatment operations will remove a large percentage of the microorganisms to which they are introduced, though not all. If these processes are used as a primary treatment, this should not preclude the need for additional disinfection of the water supply.

Figure 5

Reverse osmosis. (From Ref. 36.)

© 2003 by Marcel Dekker, Inc.

Key considerations when selecting and designing nanoﬁltration and reverse osmosis treatment systems are the choice of proper pre- and postmembrane treatment operations. The primary goal of pretreatment processes is to protect the integrity of the membranes, since they often represent a substantial portion of the capital cost. These polymeric membranes, usually some form of polyamide, though traditionally also available as cellulose acetate, are susceptible to a variety of processes and impurities which may foul or degrade them, thereby rendering them inefﬁcient, ineffective, or, in the worst case, totally destroyed. In general, the pretreatment processes will involve reducing the silt density index (plugging potential) of the feed water to the membrane. This is often accomplished by ﬁltration through sand or mixed media, or via in-line coagulation. Pretreatment also includes some form of chlorine control, either assuring that it is removed (in the case of polyamide membranes) or assuring that it is present to prevent biological degradation of cellulose acetate membrane materials. Finally, the pretreatment processes will normally include the in-line dosing of acid, antiscalant, or both. These steps help prevent a loss of membrane performance due to metal oxide fouling, scaling, or related processes which might occlude the membrane pores. Table 7 summarizes the various processes which may cause fouling (usually partially or completely reversible) or degradation (usually irreversible) of nanoﬁltration and reverse osmosis membranes. Potential solutions are also listed. The post-treatment of water exiting nanoﬁltration and reverse osmosis membrane systems is also important and should be carefully considered. Unlike the case prior to treatment, once the water has passed the membrane modules, it will be considerably more pure than when it entered. As a result, much of the microbial load is gone, as are many of the chemicophysical impurities. However, as we stressed previously, these membrane processes should not be relied upon to produce a consistently commercially sterile water. Consequently, post-treatment operations may include chemical or ultraviolet disinfection, granular activated carbon treatment, and polishing ﬁltration. In-plant process monitoring is as critical with membrane processes as it is for any other treatment modality and will usually include microbial monitoring to help gauge biofouling of the membranes and total dissolved solids or conductivity to assess the gross rejection of the membranes toward inorganic salts, pH, silt density index, chlorine residuals, and any other parameters assigned by the parent beverage company or suggested by the equipment supplier. The advantages and disadvantages of reverse osmosis, as the gold standard of membrane removal processes, are summarized in Table 8. 3. Ion Exchange The process of ion exchange, like conventional lime treatment systems, has been known to the beverage industry for decades. However, its early applications did not typically include the water to be used for product, but rather involved softening of the water (removal of calcium and magnesium) used for auxiliary plant purposes in order to prevent scaling or avoid loss of efﬁciency in heat exchangers, boilers, and bottle washers. Today, with the advent of many categories of resin materials, ion exchange is another of the valuable tools used by the beverage water technologist to help assure that the treated water used meets all of the applicable standards and guidelines expected. In its most fundamental form, ion exchange, as the name implies, involves replacing an ion which is less desirable in a particular application with one that is more desirable. In the case of the early softeners mentioned, natural ion exchange materials (called zeolites) were employed to exchange the hardness components (calcium and magnesium) in © 2003 by Marcel Dekker, Inc.

Table 7 Causes of Fouling and Degradation of Reverse Osmosis and Nanoﬁltration Membranes, Along with Possible Solutions Fouling Problem Suspended solids (in feed water)

Oxidation of metallic components (iron, manganese, etc.)

Precipitation/scaling (sulfates, carbonates, silicates, etc.)

Microbial growth (bioﬁlm formation)

Potential solutions Multimedia ﬁltration (sand, greensand, carbon) Ultraﬁltration Microﬁltration Plate and frame ﬁltration with diatomaceous earth Cartridge ﬁltration In-line coagulation Coagulation Oxidation (aeration, ozonation, chlorination, etc.); ﬁltration Greensand ﬁltration Coagulation/lime treatment Acid feed Limit recovery (in design phase) Antiscalant addition pH control Lime softening Ion exchange Chemical disinfection Ultraviolet disinfection Periodic membrane cleaning and sanitizing

Degradation Problem

Potential solutions

Oxidation

Proper membrane selection Disinfectant removal if required by membrane (carbon, bisulﬁte) Proper dosing and feedback controls

Hydrolysis (membrane breakdown at low pH)

Proper membrane selection pH control (both operating range and cleaning range) Controlled acid feed

Bacterial attack (especially for unprotected cellulose acetate membranes)

Proper membrane selection Periodic membrane cleaning and sanitizing Proper pretreatment Removal of compounds prior to membrane contact; usually via aeration or granular activated carbon

Solubilization (not very common in the beverage industry, but due to high concentrations of organic compounds with solvent properties)

water with sodium. The rationale here was that calcium and magnesium salts may often precipitate as scale inside equipment; the corresponding sodium salts, however, were much more soluble and hence did not pose a scaling concern. In this example, the supply of sodium on the zeolite to be exchanged for calcium and magnesium is not present in endless supply. Therefore, once the resin material is exhausted, it must be replenished—or ‘‘regenerated’’—with a new supply of the appropriate ion; in this case, the sodium zeolite softeners are typically regenerated with brine (sodium chloride solution). Here the excess of sodium overcomes the calcium and magnesium attached to the resin, and they are washed to the drain. The resin, now fully regenerated, is again ready to be put into service. Figures © 2003 by Marcel Dekker, Inc.

Table 8

Advantages and Disadvantages of Reverse Osmosis Systems

Advantages Removes nearly all suspended material and greater than 99% of dissolved salts in fullﬂow operation Signiﬁcantly reduces microbial load (viruses, bacteria, and protozoans) Removes nearly all natural organic matter

May be designed as a fully automated system with little maintenance Relatively small space requirements on the plant ﬂoor (footprint)

Disadvantages Pretreatment must be carefully considered and typically involves operating costs for chemicals (acid, antiscalant, chlorine removal). Does not produce a commercially sterile water. Membranes still represent a substantial portion of the capital cost and may typically last 3– 5 years. Low-solids water may be aggressive toward piping and equipment, so this must be considered for downstream operations. High pressure inlet pump is required.

Source: Adapted from Ref. 37.

6 and 7 illustrate the exchange of sodium for calcium and magnesium, and the regeneration of the resin, respectively. Ion exchange applications have broadened far beyond zeolite softening and include complete demineralization (reduction of the total dissolved solids to near zero, if desired), dealkalization (removal of alkalinity and hardness at the same time), anion or cation exchange alone, denitratization (nitrate removal), and a variety of other specialty applications, which include removal of silica, natural organic matter, iron, and other targeted impurities. The speciﬁc application depends largely on the structure of the resin material used, the characteristics of the water being treated, and the desired treated water proﬁle. Ion exchange resins for most beverage water treatment operations may be divided into two major categories: (1) cation resins, which remove positively charged ions (ca-

Figure 6 Ion-exchange reactions (softening). (From Ref. 38.) © 2003 by Marcel Dekker, Inc.

Figure 7

Ion-exchange regeneration (softening). (From Ref. 38.)

tions) like calcium, magnesium, and sodium, and which require regeneration with brine or a mineral acid; and (2) anion resins, which remove negatively charged ions (anions), like nitrate, sulfate, and chloride and which require regeneration with brine or alkali. Each of these categories may be further divided into weak and strong subdivisions, that is, weak acid and strong acid cation exchange resins and weak base and strong base anion exchange resins. Due to the nature of the chemistry at work, the cation and acid belong together, as do the anion and base. The term weak refers to the functional moiety on the resin itself and the fact that these resins will remove the weakly bonded ions in their respective class, whereas the strong resins will remove both weakly and strongly bonded ions in their groups. An increasingly popular ion exchange application for the beverage industry involves the use of a weak acid cation exchange resin. This resin is typically charged with acid, and instead of sodium (as in the zeolite softener) these resins will exchange the acid proton or hydrogen ion for weakly bonded cations in the water. The predominant cations removed are those that comprise hardness, calcium and magnesium. In addition, some sodium may be removed in the process, but only after the hardness is removed. As the hardness is removed, and exchanged for hydrogen ions, these hydrogen ions combine with the naturally occurring bicarbonate alkalinity in the water to form carbonic acid (H2 CO3 ). This newly formed carbonic acid quickly dissociates into water and carbon dioxide, and the carbon dioxide is usually removed with a downstream degasiﬁer. By forming the carbonic acid and removing the carbon dioxide, the alkalinity of the water is reduced proportionately. Hence, the weak acid cation exchange resin, in the acid form (as opposed to the sodium form, as the zeolites), removes both hardness and alkalinity in one treatment unit. The caution with this application is that if used alone, other operations must accompany the ion exchange (e.g., disinfection, ﬁltration, activated carbon, etc.) since softening and alkalinity removal are the major beneﬁts of this treatment. If anion impurities are a problem in the water supply (nitrate, chloride, sulfate), then these weak acid resins will have no effect on these contaminants. Some companies whose water source is of a demonstrated, consistent supply use weak acid cation exchange resins preceded by in-line coagulation. This combination affords the removal of turbidity, suspended solids, and some protozoans © 2003 by Marcel Dekker, Inc.

(from the coagulation), along with the removal of alkalinity and hardness by the resin itself. Ion exchange alone affords no disinfection or microbial protection, unlike conventional lime treatment systems and membrane processes. Consequently, they must be augmented by the appropriate additional treatment to result in the ﬁnal water quality proﬁle desired. In some cases, the resin beds themselves may promote the growth of bacterial populations and, once established, may be very difﬁcult to fully overcome. Some suppliers recommend the installation of an ultraviolet disinfection loop to help protect the resin unit from microbiological proliferation during periods when not in use. In general, cation resins are more resilient materials and may be disinfected with a variety of sanitizers, including chlorine solutions, permanganate, peracetic acid, and formaldehyde. This is usually not true for anion resins, which may be more prone to osmotic shock from changes in ionic strength, water temperature, or pH extremes. In some cases, anion resins—usually strong base anion material—have been implicated in causing off-odors (‘‘ﬁshy’’) in the treated water exiting their beds, which may be due to the methylamine breakdown products of some anion resins. In all cases, the supplier of the resins should be consulted for the proper operational, regeneration, and disinfection procedures to be used with their particular resin. C. Support Technology Support technology is a term used to describe the ancillary unit operations which are typically not considered primary treatment. Rather, they are intended to augment the primary treatment to result in a robust, complete treatment chain designed to deliver the quality of treated water we require for food and beverage plant applications. Given this deﬁnition, a wide variety of unit operations may be grouped into this category, but this section will only address two of the more common support technologies—media ﬁltration and activated carbon puriﬁcation. 1. Media Filtration Media ﬁltration, in the simplest terms, involves the passage of water through any of a variety of coarse ﬁltration materials. Traditionally, the most common medium for beverage water treatment was simple ﬁltering sand, supported by a bed of gravel. The major purpose of these sand ﬁlters was—and still is—to provide a coarse straining of the water stream. Sand ﬁlters may be located at different points in the treatment chain, but for conventional lime treatment systems, the industry practice is to locate the sand ﬁlter downstream of the reaction tank. Logically, this was done to capture any loose ﬂoc carryover, precipitated calcium carbonate, or other particulates that might not have settled adequately in the reaction tank. In some applications, like in-line coagulation, the deep bed sand ﬁlter which is used serves not only to ﬁlter the ﬂoc that is intentionally formed in line, but to provide part of the contact time of the water with the chlorine disinfectant. As the choice of primary treatment technologies available to the beverage technologist has increased over time, so has the choice of support operations. In addition to sand, other media are commercially available to suit a variety of applications. For example, some reverse osmosis and nanoﬁltration membrane systems might incorporate ‘‘greensand’’ as one of the pretreatment operations. Greensand is a naturally occurring mineral that consists largely of dark greenish grains of glauconite possessing ion exchange properties [17] and is used for the removal of soluble iron and manganese from water streams to prevent fouling of downstream membrane systems. Other media used include garnet, anthracite, © 2003 by Marcel Dekker, Inc.

and diatomaceous earth, each having its own niche application. These media may also be combined in dual media or mixed media ﬁlters. Regardless of the medium selected, the fundamental objectives of media ﬁltration include (1) removal of particulates from the overﬂow of reaction tanks, (2) preventing the occlusion of carbon pores, (3) avoiding the surface occlusion or fouling of ion exchange resins, and (4) providing the required contact time for chlorine and coagulant. In general, the supplier of water treatment equipment will routinely suggest media with which they have had positive operating and quality histories. Media ﬁltration, like virtually all water treatment processes, requires diligent maintenance in order to help assure its on going performance. Since media ﬁlters remove particulate matter from the water, these impurities must then somehow be removed from the ﬁlter itself. This is accomplished by frequent backwashing of the ﬁlter medium, often with treated water, to suspend and expand the ﬁlter bed into the freeboard of the ﬁlter vessel, thereby allowing collected impurities to be washed to the drain. Some media ﬁlters, more commonly in municipal applications, augment the water backwash by the injection of air. This air scouring also helps suspend the bed and conserves the overall volume of water necessary for the backwash cycle. The frequency and conditions of backwash depend on the ﬁlter media, vessel design, supplier recommendations and corporate policies, although the range of operating conditions usually include a frequency of anywhere from daily to monthly and a backwash rate of from two to ﬁve times the normal ﬂow. Intimately linked with the maintenance described is the routine sanitation of the media ﬁlters. Several methods may be used, including heat and chemical sanitizers, but this critical operation must not be overlooked. It is possible for bacterial populations to become established in media ﬁlter beds and subsequent mucilagenous bioﬁlms to form in and on the ﬁlter media which may be extremely resistant to removal. 2. Carbon Puriﬁcation In the ﬁeld of water treatment, carbon puriﬁcation is arguably the single unit operation that provides the broadest protection against the widest range of possible contaminants. In fact, the U.S. Environmental Protection Agency has routinely identiﬁed activated carbon as the ‘‘best available technology’’ for the removal of a wide variety of volatile and semivolatile organic impurities [10], which are summarized in Table 9. In addition to these, thousands of other organic compounds show some degree of removal by activated carbon. This application of organic impurity removal is relatively new to the beverage industry, despite the fact that activated carbon has been a part of beverage water treatment systems for many decades. The primary use of activated carbon in this ﬁeld has been to effect the removal of the chlorine species used to disinfect the treated water. Here, a critical distinction must be drawn between the adsorptive mechanisms of contaminant removal by carbon and the catalytic mechanisms carbon employs to dechlorinate. Adsorption refers to the adhesion, bonding, and other chemical attractive forces which retain impurities on the surface of the carbon and within its pores. This is usually a reversible process, to varying degree. The catalytic mechanism refers to the formation of a surface oxide on the activated carbon medium as a result of the reaction of the carbon with the hypochlorous acid, according to the following reaction: HOCl

⫹

hypochlorous acid

C* → carbon

HCl

⫹

hydrochloric acid

C*O carbon surface oxide

Unlike adsorption, the catalytic reaction is not reversible, and, in fact, carbon bulk is destroyed in the process. © 2003 by Marcel Dekker, Inc.

Table 9 Organic Contaminants for Which Activated Carbon Has Been Identiﬁed as the Best Available Technology for Their Removal Alachlor Aldicarb Aldicarb sulfone Aldicarb sulfoxide Atrazine Benzene Benzo[a]pyrene Carbofuran Carbon tetrachloride Chlordane Dalapon 2,4-D Di(2-ethylhexyl) adipate Di(2-ethylhexyl) phthalate Dibromochloropropane (DBCP) o-Dichlorobenzene para-Dichlorobenzene 1,2-Dichloroethane 1,1-Dichloroethylene cis-1,2-Dichloroethylene trans-1,2-Dichloroethylene 1,2-Dichloropropane Dinoseb Diquat Endothall Endrin

Ethylbenzene Ethylene dibromide (EDB) Heptachlor Heptachlor epoxide Hexachlorobenzene Hexachlorocyclopentadiene Lindane Methoxychlor Monochlorobenzene Oxamyl (vydate) Pentachlorophenol Picloram Polychlorinated biphenyls (PCB) Simazine Styrene 2,3,7,8-TCDD (dioxin) Tetrachlorethylene Toluene Toxaphene 2,4,5-TP (silvex) 1,2,4-Trichlorobenzene 1,1,1-Trichloroethane 1,1,2-Trichloroethane Trichloroethylene Xylene

Source: Refs. 10, 11.

Carbon may be obtained from a variety of different starting materials, for example, coal, wood, peach pits, coconut shells. The carbon is activated either thermally (steam) or chemically. Steam activation, the more common, involves two steps: carbonization and activation. Carbonization involves the conversion of the raw material into a disordered carbon structure with a very low volatile content. Carbonization is done at elevated temperatures in an oxygen-lean environment which keeps it from burning. In activation, some carbon atoms are vaporized, leaving behind the highly porous structure. Steam activation is carried out in temperatures of approximately 1800 °F (982 °C). At these conditions, carbon reacts with steam to form carbon monoxide and hydrogen, which exit as gases. The result is a highly porous carbon material. Chemical activation is used to produce very high pore volume in wood-based carbons, particularly in the medium-size pore range. The most common process consists of mixing wood dust or some other cellulose-based material with a strong dehydrating agent and then heating to a designated temperature. The activating agent not only extracts moisture, but helps prevent collapse of the pore structure during activation [18]. Activated carbon is generally available in the powdered or granular form, but granular activated carbon (GAC) is used for the vast majority of water treatment applications in the beverage industry. In addition to the volatile organic impurities mentioned and the © 2003 by Marcel Dekker, Inc.

removal of chlorine and chloramine, GAC also affords treated water protection against adversely sensory-active compounds, like the microbial metabolites geosmin and 2-methyl isoborneol. These compounds may be odor active in nanogram per liter concentrations, and they represent a substantial proportion of off-odor complaints to municipal water treatment works [19]. Operationally, perhaps even moreso than for media ﬁltration, the activated carbon unit operation must be diligently maintained and sanitized. Many microbial complaints and sensory excursions in the beverage industry have been linked, at least in part, to inadequate carbon bed management practices. One of the reasons for this required diligence is that the core of the GAC bed has the potential to provide optimal conditions for the growth of troublesome microorganisms—speciﬁcally, the chlorine is absent, the environment can vary in its level of air or dissolved oxygen, and, in most cases, the organic microbial nutrients abound (since GAC is so proﬁcient at removing organic compounds, including natural organic matter, from water supplies). These conditions combine to make carbon an excellent medium for the support of microbial growth. Once established, the extremely large surface area within the carbon pores can make control of an unwanted microbial population a daunting task. As is the case with media ﬁlters, routine and diligent backwashing and sanitization of the carbon bed should be viewed as an absolute requirement for any beverage plant water treatment system. Hot water, steam, or a combination are generally employed to sanitize the carbon ﬁlters, provided their material of construction can withstand the temperature needed. When performed regularly, this helps prevent a bioﬁlm from becoming ﬁrmly established in the bed, and helps avoid the problems often associated with poor carbon maintenance, including high bacteria counts, off-odor production within the bed, poor dechlorination or chlorine breakthrough, and loss of adsorptive capacity. D.

Disinfection

At the beginning of this chapter, the food and beverage producer’s commitment to consumer and employee safety was stressed as being a paramount goal of water treatment in our industry. Microbiological contamination, in addition to resulting in spoilage of the beverage, represents an acute potential threat to the quality of our products and the integrity of our trademarks. Therefore, overall microbial management is critical to the success of any beverage producer. This section focuses on the major techniques employed for disinfection as it speciﬁcally relates to the water used for beverage products. As an introduction, a distinction between cleaning, sanitizing, and sterilizing must be drawn. Cleaning may be described as the removal of soil particles from surfaces by rinsing and washing through the use of physical and chemical action. Sanitizing, in our industry, refers to treating a cleaned surface to destroy contaminant organisms and reduce the total vegetative cell population to a safe level. Finally, sterilizing is the complete destruction of all organisms, including spores, through the use of chemical agents, heat, radiation, or other means. These are largely intuitive, yet critical concepts to recognize. Unlike many pharmaceutical or ultra–clean room applications, which may require commercially sterile water, the beverage industry does not. Our requirements, in nearly all cases, dictate a ‘‘sanitary’’ treated water supply, not a ‘‘sterile’’ one. That is, we diligently ‘‘control any contaminant organisms . . . to a safe level.’’ 1. Primary Organisms of Concern The speciﬁc organisms of concern for the water treatment system of a beverage producer must be identiﬁed by the corporate research and development functions, with probable

© 2003 by Marcel Dekker, Inc.

guidance by any applicable drinking water and food regulations. The World Health Organization asserts that ‘‘infectious diseases caused by pathogenic bacteria, viruses, and protozoa or by parasites are the most common and widespread health risk associated with drinking water’’ [13]. It would be impossible and irrational to attempt to test all potential microbial threats to a water supply. Consequently, the focus of most major regulatory bodies is on testing and monitoring recognized ‘‘indicators’’ of water quality. Perhaps the most notable and widely accepted group of indicator organisms is the coliform group, which refers to gram-negative, rod-shaped bacteria capable of growth in the presence of bile salts or other surface-active agents with similar growth-inhibiting properties and able to ferment lactose at 35–37°C with the production of acid, gas, and aldehyde within 24– 48 hr. They are also oxidase negative and nonsporeforming. By deﬁnition, coliform bacteria display beta-galactosidase activity [13]. The real threat to public health and safety is from those waterborne organisms transmitted as a result of direct contact with fecal contamination. Because not all coliform organisms are of fecal origin, other indicator tests are used to help detect the possibility of unsanitary conditions in a water supply. These include fecal or thermotolerant coliform, with Escherichia coli being the most prominent member [20], fecal Streptococci, and anaerobic, sporeforming bacteria, the target of which is primarily Clostridium perfringens. The most common bacterial measurement in municipal water supplies and in beverage plant water treatment monitoring remain total coliform and E. coli. In addition, a total bacterial plate count is commonplace for routine monitoring, but more as an indicator of acceptable good manufacturing practices (GMP) rather than as an indicator of the presence of fecal organisms. One notable exception to this industry practice is in the production and packaging of a natural mineral water. In most countries where regulations for natural mineral waters exist, disinfection is realistically not allowed for these products. Instead, the focus is on impeccable selection and monitoring of a source as close to pristine as possible. Part of this rigorous monitoring may include all of the organisms mentioned, in addition to others (like Pseudomonas aeruginosa, for example). The rationale is to help assure optimal conﬁdence that the natural mineral water being abstracted from the source and subjected to minimal treatment, at best, is as microbially risk-free as feasible. Another organism that has recently become a threat to both the municipal and industrial water treatment arenas is the protozoan Cryptosporidium parvum. Cryptosporidium is a protozoan parasite affecting the gastrointestinal tract of humans and animals. It is shed in the feces in the form of an ‘‘oocyst,’’ which has a hard shell to protect it from the environment. This also makes it highly resistant to disinfection by chlorine and ozone; although, UV disinfection has proven to be extremely effective at its inactivation. Waterborne Cryptosporidium outbreaks have occurred in both large and small communities, with the largest outbreak occurring in Milwaukee, WI in 1993, affecting an estimated 403,000 people. Such outbreaks have caused major disruption to residents, businesses, and government. Infection with the Cryptosporidium organism may also have contributed to the premature deaths of immunosuppressed individuals in these outbreaks. Because of this, the ﬁnding of Cryptosporidium oocysts in many drinking water sources (rivers, lakes, and reservoirs), and occasionally even in municipal treated water, has been a source of considerable concern to drinking water and public health ofﬁcials, as well as to the public and the news media [21]. In addition to waterborne organisms of health concern, water supplies may also be subject to inhabitation by ‘‘nuisance organisms.’’ These organisms, as their name implies, are typically not associated with any direct health effects, but rather are known to cause aesthetic or operational concerns to the water treatment plant or distribution network. In

© 2003 by Marcel Dekker, Inc.

reality, most beverage producers will not test for these nuisance organisms unless a problem is known to exist (which is usually detected initially by an off-odor in the water plant, or by metallic particles in the system). Bacteria in this broad category include the following [22]: 1.

2. 3.

Iron bacteria. These bacteria incorporate ferrous iron as part of their normal physiological processes and oxidize it to the insoluble ferric form. Genera include Leptothrix, Clonothrix, and Gallionella. Manganese bacteria. Instead of iron, these bacteria may incorporate manganese and oxidize it. Genera include Hyphomicrobium and Caulobacter. Sulfur bacteria. Many subgroups of sulfur bacteria exist, depending on the speciﬁc sulfur form utilized as a nutrient substrate. The more troublesome group to the beverage water treatment plant is the sulfate-reducing bacteria (SRB), since they produce the malodorous hydrogen sulﬁde. These include the genera Desulfovibrio and Desulfotomaculum. Some species of Pseudomonas have also been implicated in producing organo-sulfur compounds in water.

2. The CT Concept A critical concept when forming the foundation for any discussion of disinfection is the CT concept. In this mathematical product, the C refers to the ﬁnal residual concentration of a particular chemical disinfectant, in mg/L, and the T refers to the minimum contact time, in minutes, that the material being disinfected has been in contact with the disinfectant. Therefore, the units of CT are expressed in mg-min/L. To explore this in more detail, we must ﬁrst recognize that every water supply has a natural disinfectant ‘‘demand.’’ The demand may be described as the utilization of a disinfectant by components in the water which must ﬁrst be satisﬁed before a residual disinfectant concentration may be established. Impurities like soluble metals, particulates, natural organic matter, microorganisms, etc., all contribute to the demand of a particular water supply. Before we can conﬁdently begin to disinfect this supply, we must ﬁrst provide the water with enough disinfectant to react with these components. Once this is accomplished, we may then establish a ‘‘residual’’ disinfectant concentration. After this residual is established and conﬁrmed via testing, we must then maintain this residual in contact with the water over the course of the required contact time. This concept explains why in a conventional lime treatment system, a chlorine dose as high as 12–20 mg/L is often required to result in a free chlorine residual of between 6 and 8 mg/L. The dose must be adequate to satisfy the demand and then establish a residual. Simply put, the residual is equivalent to the arithmetic difference between the dose and the demand. Many regulatory and industry organizations have adopted the CT concept to express relative values of a disinfectant’s effectiveness against a particular organism under a deﬁned set of conditions (temperature, pH, etc.). Often, published tables of CT data will include a subscript, for example, CT 99.9 , which describes the log removal of a particular organism when tested against a particular disinfectant. The 99.9 subscript in this example indicates that for this particular CT data, a three-log, or 99.9% reduction in the target organism has been demonstrated. Table 10 provides further illustration of the CT concept using real data from the U.S. Environmental Protection Agency. The table values include CT 99 , or the CT ranges within which 99% of the target organisms were inactivated by the disinfectant. A bacterium, virus, and protozoan are compared insofar as their susceptibility to free chlorine, © 2003 by Marcel Dekker, Inc.

Table 10 Comparison of CT Values for Inactivation at 5°C (mg-min/L)

Organism

Free chlorine, pH 6–7

Preformed chloramine, pH 8–9

Chlorine dioxide, pH 6–7

Ozone, pH 6– 7

E. coli (bacteria) Polio 1 (virus) G. lamblia (protozoan)

0.034–0.05 1.1–2.5 47–150⫹

95–180 770–3740 —

0.4–0.75 0.2–6.7 —

0.02 0.1–0.2 0.5–0.6

Source: From Ref. 26.

preformed chloramine, chlorine dioxide, and ozone. Many conclusions may be drawn from this single tabulation, which will summarize the discussion of CT: 1. Compared to the other disinfectants, preformed chloramine is virtually ineffective at inactivating polio 1 virus (note the very high CT value of 770–3740 mgmin/L). 2. In general, ozone is the most effective disinfectant against all categories of the organisms studied (note the very low CT values in the ozone column). 3. Except for preformed chloramine, the other disinfectants are markedly effective against E. coli and Polio 1 (in most cases, CT values are well below 1). Critical concepts with regard to CT data include: (1) the disinfectant demand must ﬁrst be satisﬁed; (2) the disinfectant residual must then be established; (3) this residual must be maintained for the minimal contact time speciﬁed in order to provide adequate protection; and (4) ‘‘dose’’ and ‘‘residual’’ must not be confused or equated. 3. Major Disinfectants A variety of disinfectants is currently available for use in beverage water treatment applications, but this section will focus on the three most common: chlorine species, ozone, and ultraviolet irradiation. The perspective presented will be from that of direct disinfection of the water to be used for beverage production. Note, however, that the disinfection of surfaces and equipment in the water treatment room and throughout the beverage plant is often treated as a separate topic, and additional sanitizing techniques may be used for these applications, with one of the most effective being heat. However, surface and plant disinfection are beyond the scope of this chapter. a. Chlorine Species. Chlorine is commercially available to the beverage industry as compressed chlorine gas, solid calcium hypochlorite pellets, and sodium hypochlorite solution of various concentrations. The traditional and likely the most commonly used form for disinfection of treated water is the last, sodium hypochlorite solutions, although the others are also employed. Chlorine gas is usually reserved for large-volume beverage plants, and considerable drawbacks to its use are the strict transport, handling, storage, metering, permitting, and use requirements being enforced by many regulatory agencies. Calcium hypochlorite is utilized, although, in many markets, is more costly than sodium hypochlorite. Irrespective of which form is chosen, once in aqueous solution, the chlorine chemistry becomes essentially the same. The chlorine species, when dissolved in water, will eventually dissociate into primarily two active forms: hypochlorous acid (HOCl) and the hypochlorite anion (OCl-). The © 2003 by Marcel Dekker, Inc.

ratio of these two chlorine species varies as a function of pH, with hypochlorous acid predominating at acidic pH, and the hypochlorite anion predominating at alkaline pH [23]. Figure 8 depicts the relative equilibria, as a function of pH, for chlorine, hypochlorous acid, and the hypochlorite anion. One critical concept to link with these chlorine equilibria is that hypochlorous acid (predominant at lower pH) has been described as 80 to 100 times more potent a germicide than the hypochlorite anion (predominant at higher pH). As a result of this, the World Health Organization suggests a pH of less than 8.0 to help assure effective disinfection of water with chlorine. In conventional lime water treatment systems, where the operating pH in the reaction tank is often above 10.0, the chlorine equilibrium favors the existence of hypochlorite anion, which is why, in addition to allowing adequate ﬂoc settling time, a minimum of 2 hr of retention must be designed in these systems. In summary; chlorine is an effective disinfectant against bacteria and viruses, although it is less effective against protozoan organisms like Giardia and Cryptosporidium. The effectiveness of chlorine varies markedly with pH, owing to the distribution between the more effective hypochlorous acid and the less effective hypochlorite anion. The preferred operating range for chlorine disinfection is roughly pH 6.0 to 7.5; below this, corrosion may occur, and above this, its effectiveness declines. Though the actual disinfection criteria for your application must be decided within your own corporation, a long-standing industry practice for water disinfection using chlorine in conventional treatment systems is to maintain a free chlorine residual of 6 to 8 mg/L over the course of a 2-hr contact time. For other treatments, where the pH is lower, this CT is often decreased. b. Ozone. Ozone (O3 ) is an unstable, gaseous, allotrope of oxygen (O2 ). It has a distinctive pungent odor, from which its name is derived (from Greek ozein, to smell). It is formed locally in air by the ionizing effects of environmental lightning and in the earth’s stratosphere by ultraviolet irradiation. It also safeguards us from the damaging effects of the sun by inhibiting the penetration of much of the sun’s ultraviolet waves, preventing them from reaching the planet’s surface. It is also formed during combustion in automobile engines, and thereby contributes to the troublesome phenomenon of photochemical smog. Following the lead from many municipal drinking water companies that have used ozone for decades, the beverage industry more formally recognized its use in 1981 by the publication of ‘‘Ozone Treatment of Beverage Water’’ in the Proceedings of the International Society of Beverage Technologists [24] and then again in its 1987 proceedings with

Figure 8

Chlorine species as a function of pH. (Adapted from Ref. 23.)

© 2003 by Marcel Dekker, Inc.

‘‘Applications of Ozone in Soft Drink Bottling Plants’’ [25]. The major applications then, which continue to be currently valid, are the use of ozone as an oxidant and as a disinfectant. The major use of ozone in the beverage industry currently is the treatment of bottled water. Its use in the treatment of water for carbonated soft drinks is still uncommon. Commercially, ozone is produced via the corona silent arc discharge process [26]. The major drawback with the use of ozone, due to its very short half-life, is that it cannot be efﬁciently stored. It must be produced on-site at the point of use. With the corona discharge, a feed gas (oxygen or air) passes through an electrode pair (high and low voltage), where free electrons are of sufﬁcient energy to split the diatomic (i.e., two atoms) oxygen molecules apart. The single atomic oxygen species then recombine with other diatomic oxygen to form a molecule with three atoms of oxygen—ozone. When compressed puriﬁed oxygen gas is used as the feed, in place of treated air, roughly twice the amount of ozone is produced for the same energy input. For most bottled water applications (where ozone is frequently used), even despite the increased output, the cost of the compressed oxygen usually makes its use uneconomical. There are many designs of ozone generators—tubular, plate, water-cooled, refrigerated air–cooled, etc.—but the most important design characteristic is the treatment of the feed gas. The ozone generator must include modules for air compression and pressure regulation; cooling; particulate ﬁltration; water vapor removal (dryers); gas impurity removal (methane, ammonia, etc.); and oil (hydrocarbon) removal. Along with the ozone generator should come some form of ozone destruct device (usually thermal or catalytic) to destroy the excess ozone off-gas. As a water disinfectant, the effectiveness of ozone varies widely with the speciﬁc organism of interest. For example, at 5°C, and a pH of 6–7, to obtain the same degree of inactivation (99%), the following CT conditions must be used [27]: 1. 2. 3. 4. 5.

E. coli bacteria: CT ⫽ 0.02 mg-min/L Polio 1 virus: CT ⫽ 0.1–0.2 mg-min/L Giardia lamblia cysts: CT ⫽ 0.5–0.6 mg-min/L Giardia muris cysts: CT ⫽ 1.8–2.0 mg-min/L Cryptosporidium parvum cysts: 5–6 mg-min/L, estimated

As with any chemical disinfectant, when ozone is used for disinfecting water supplies, the ozone demand must ﬁrst be met, and then a residual ozone concentration established and maintained for the desired contact time. An industry practice, which dates back to data nearly four decades old, is to utilize an ozone CT value of 1.6 mg-min/L. This is generally done by maintaining a residual of 0.4 mg/L ozone for 4 min. You will notice from the data given, that a CT of 1.6 mg-min/L is adequate to provide at least a two-log reduction in bacteria, virus, and Giardia lamblia populations. However, as with chlorine, Cryptosporidium parvum remains resilient to inactivation, so higher CT values are necessary to address this organism. Operationally, the two major drawbacks to the more widespread application of ozone to our industry include the fact that it must be generated on-site and used immediately and cannot be stored, and due to its short half-life, it does not provide adequate residual disinfectant activity. As with other disinfectants, the dose and half-life of ozone will vary as a function of pH, temperature, organic matter, and other variables, but somewhat unique to ozone is its behavior at varying levels of total dissolved solids (TDS). Table 11 illustrates the time, in minutes, for the disappearance of initial ozone doses of 0.64, 0.32, and 0.16 ppm in waters of varying levels of total dissolved solids [28]. Note the magnitude of the inverse relationship between ozone half-life and total dissolved solids. The lower © 2003 by Marcel Dekker, Inc.

Table 11 Ozone Half-Life as a Function of Total Dissolved Solids at 70°F

Total dissolved solids (ppm)

Time (in minutes) for disappearance of an initial ozone concentration of

Ozone half-life (min)

0.64 ppm O 3

0.32 ppm O 3

0.16 ppm O 3

5.7 29 119

28.5 222 594

22.8 174 474

17.1 132 360

500 400–450 1

Source: Adapted from Ref. 28.

the level of total dissolved solids, the longer the ozone residual will last. Finally, ozone is a very powerful chemical oxidant, and can be extremely aggressive toward equipment, both in air and in aqueous phase. Care must be taken to ensure that all materials used are suitable for ozone contact and that all employee safety precautions are observed. c. Ultraviolet Irradiation. The last of the major disinfectants used for water treatment in the beverage industry is ultraviolet irradiation. Ultraviolet (UV) radiation energy waves are the range of electromagnetic waves 100 to 400 nm long (between the x-ray and visible light spectra). The division of UV radiation may be classiﬁed as vacuum UV (100–200 nm), UV-C (200–280 nm), UV-B (280–315 nm), and UV-A (315–400 nm). In terms of germicidal effects, the optimal UV range is between 245 and 285 nm. Ultraviolet disinfection utilizes a mercury source in the form of either low-pressure lamps that emit maximal energy output at a wavelength of 253.7 nm; 2) medium-pressure lamps that emit energy at wavelengths from 180 to 1370 nm; or lamps that emit at other wavelengths in a highintensity ‘‘pulsed’’ manner. Pulsed UV is a relatively new technology to the beverage industry, and is not widely employed at present. While both low- and medium-pressure designs have their own advantages and disadvantages, they have both proven to be adequate for water disinfection applications. The degree to which the destruction or inactivation of microorganisms occurs by UV radiation is directly related to the UV dose. The UV dosage, D, is calculated as the arithmetic product of intensity, I, in milli- or microwatt-seconds per square centimeter, and time, t, in seconds. Internationally, the dose is often expressed in millijoules per square centimeter, which is exactly equivalent to milliwatt-seconds per square centimeter (1 mJ/ cm2 ⫽ 1 mW-s/cm2 ⫽ 1000 µW-s/cm2 ). Research indicates that when microorganisms are exposed to UV radiation, a constant fraction of the living population is inactivated during each progressive increment in time. This dose-response relationship for germicidal effect indicates that high-intensity UV energy over a short period of time would provide the same kill as a lower intensity UV energy at a proportionally longer period of time. The UV dose required for effective inactivation is determined by site-speciﬁc data relating to the water quality and log removal required [29]. The mechanism of inactivation of microorganisms by UV is complicated, but has been reported many times in the literature. Fundamentally, the organism’s genetic material (e.g., bacterial deoxyribonucleic acid, or DNA) absorbs the UV radiation, which results in a chemical disruption of the DNA’s chemical bases. Though many various photoproducts form as a result of this, the major rearrangement is the dimerization of the thymine base. This change renders the organism unable to replicate its DNA and, therefore, unable © 2003 by Marcel Dekker, Inc.

to reproduce. As you might expect, ultraviolet disinfection does not provide any residual disinfectant activity. Just as with ozone and chlorine, ultraviolet energy also has an accepted industrial rule of thumb which has been established for decades. A typical UV system used for the disinfection of beverage plant water treatment is sized to deliver a dose of at least 30 mJ/ cm2 at the end of its service life (typically 8000 hr). To achieve this, since UV intensity naturally decreases over time as the lamp ages, the initial dose design is usually on the order of 60 mJ/cm2. This design has traditionally been credited with providing at least a three-log (99.9%) inactivation of bacterium, yeast, and virus populations. Data published in late 1999 [30], and conﬁrmed since then in several industry journals, suggest that the same 30 mJ/cm2 dose also provides at least a three-log inactivation of Cryptosporidium parvum, a protozoan organism highly resistant to disinfection by chlorine and ozone. Table 12 summarizes the relative effectiveness of a variety of disinfectants against C. parvum. This is promising news for the water treatment industry, since it now adds UV to our armamentarium of weapons to help ensure the microbial safety of our water supplies. 4. The Multiple Barrier Approach The multiple barrier approach, as the term implies, refers to the installation of any combination of multiple barriers in a water treatment chain to help decrease the risk of microbial contamination. These barriers may be physical (reverse osmosis, microﬁltration, coagulation, etc.), chemical (ozone, chlorine, UV, etc.), or a combination of the two. Multiple barrier design, though it applies correctly to the protection against any microbial threat, was the subject of increased interest after the Milwaukee Cryptosporidium outbreak in 1993. That outbreak, and the research done in its wake, helped demonstrate the resilience of that protozoan organism to traditional disinfection. An alternative approach was needed. That approach became the multiple barrier concept. The Milwaukee outbreak also arguably spurred a heightened focus on the area of emerging pathogens, with the hope of being able to proactively identify troublesome microorganisms and apply appropriate treatment technology to address them. The multiple barrier concept is becoming more recognized by both regulatory agencies and members of industry. This trend is likely to continue, since intuitively it should be able to address, at least to some degree, most microbial threats in the future. Considering the wide range of chemical and physical unit operations and combinations thereof available to the beverage water treatment technologist, we should be well-armed to design a robust treatment system to address many of the threats that might face us in the future. The key

Table 12

Relative Comparison of Various Methods for 99% Cryptosporidium Inactivation

Disinfectant Free chlorine Chloramine Mixed oxidants Ozone Chlorine dioxide UV irradiation Source: From Ref. 39.

© 2003 by Marcel Dekker, Inc.

Effectiveness

Estimated CT-99

Poor Poor Fair Good Good Excellent

7200 mg-min/L 7200 mg-min/L 1000 mg-min/L 5–15 mg-min/L 80 mg-min/L 2–5 mJ/cm2

is to work with municipalities, researchers, the private sector, and other resources to build and sustain a network of expertise. Then, when a ‘‘new’’ pathogen arises, the industry should draw from this skills reservoir to take the necessary precautions to continue to protect public and consumer health and the integrity of our brands. In the beverage industry, many plants can conﬁdently apply at least three microbial barriers—coagulation (conventional lime treatment systems), chlorine (primary disinfection), and UV irradiation (secondary disinfection and extremely effective against Cryptosporidium). In general, the more barriers in place, the greater our conﬁdence that we are providing treated water with adequate protection against microbial impurities. This is a simple concept but far reaching in implication. IV. TESTING AND MONITORING To keep pace with the changes in today’s regulatory environment, the food and beverage industries must recognize a two-pronged approach as it relates to the testing of water in their facilities. The ﬁrst incorporates testing required from a regulatory perspective. In this case, regulatory includes not only formal bodies like the Environmental Protection Agency or the Councils of the European Union, but also our own corporate regulatory departments. This type of testing is typically quite rigorous and is concerned primarily with the protection of the consumer and the environment. The second approach incorporates the day-to-day testing required to keep our treatment processes functioning effectively and to assure that our ﬁnal treated water used in product consistently meets acceptable standards. This section is intended as a primer to stimulate more in-depth investigation by the individual company, rather than a complete treatise of analytic methodology that might be employed. What should you test? An anecdote paraphrased from a supposedly ‘‘ancient unnamed philosopher’’ was once credited with the quotation, ‘‘To some extent, water can dissolve every naturally occurring substance on earth. Proof of this is limited only by our ability to detect species’’ [31]. As modern analytic chemistry continues to evolve, this philosopher must be heralded as the visionary he must have been. For example, Environmental Protection Agency Method 1613B allows the quantitation of polychlorinated dibenzodioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) down to part-perquadrillion levels [32]. As the levels of detection improve, the question will no longer be ‘‘is this compound in our water?’’ Rather, it will become ‘‘we know it’s there, but what level is acceptable?’’ To try to simplify this complex and case-speciﬁc area, the food or beverage plant should consider dividing water-related testing into ﬁve categories: 1. 2. 3. 4. 5. A.

Testing for new plant site qualiﬁcation Testing for regulatory compliance In-plant testing Testing to incorporate individual company requirements Troubleshooting

Testing for New Plant Site Qualiﬁcation

This category of testing is usually considered the most rigorous and typically encompasses testing for the broadest range of potential contaminants. It is often driven by the federal and local regulations that apply to the transaction of commercial real estate during a due diligence period. In the United States, this may include a simple ‘‘transaction screen,’’ © 2003 by Marcel Dekker, Inc.

which is categorized by obtaining data primarily through visual inspection, surveys and interviews, and previous testing; or it may range through a Phase III Environmental Site Assessment, which is a data-based quantitation of an identiﬁed site hazard. For more information, the American Society for Testing and Materials has published ‘‘Standard Practices for Environmental Site Assessments’’ [33], which should be reviewed by anyone involved in this initial phase of testing. B. Testing for Regulatory Compliance This category of testing is also rigorous and has the primary function of protecting public health and safeguarding the corporate trademark. It typically represents an appreciable cost to the food or beverage manufacturer. The expense may be due to the capital investment needed for compliance (e.g., a gas chromatograph with mass spectrometric detector to monitor trihalomethanes and other volatile organic compounds in potable water) as well as to the ongoing operating costs of external third-party laboratories or contracted companies to manage a plant’s overall compliance. The food and beverage manufacturer must be aware that regulatory compliance rarely, if ever, involves a single regulatory agency. Two is a common number in the United States for example, the Environmental Protection Agency for jurisdiction over potable water as it enters the food or beverage processing plant and the Food and Drug Administration for jurisdiction over a ﬁnished packaged water. Outside the United States, the maze of presiding regulatory bodies may be even more complicated. For example, some years ago, at a natural mineral water facility in Poland, the plant was expected to comply with the Council Directive of the European Union (since the country followed EU trends); the Federal Regulations for Poland; the regional Codes of the Vovoidship of Radom; and the local laws as promulgated by the Warsaw authorities. The chemical, physical, microbiological, and radiological testing had to, therefore, follow suit. Tracking regulatory trends is best left to the experts, and virtually all major food and beverage companies have entire departments devoted to doing just that. Historically, compliance monitoring has been criticized for the tedium and analyst sophistication necessary in the ofﬁcial analytic methods. Also, though the water-related agencies of the federal government have been doing a laudable job, they have been doing so with ever-dwindling resources. This has lead to an ofﬁcial documentation system which is sometimes months or years behind the most current developments. However, the future is bright for regulatory compliance monitoring as many regulatory bodies join the internet age [34]. C. In-Plant Testing This category should include the more routine, plant ﬂoor–friendly testing that is required to operate a food or beverage plant on a day-to-day basis. It is generally intended for use as a surrogate system for fast, easy monitoring; the parameters measured should serve as a red ﬂag assessment for when the next phase of more intensive testing is warranted. For example, in beverage water treatment systems, especially for those utilizing polymeric membrane technology (i.e., reverse osmosis or nanoﬁltration), the measurement of total dissolved solids is an excellent aggregate parameter to use as a surrogate measure of the overall rejection performance of the membrane. Simply put, TDS provides a fast, easy, in-line, reproducible method by which to monitor how effectively your membrane is rejecting dissolved salts. If the TDS changes suddenly, it raises a red ﬂag that further data collection is necessary (e.g., visual inspection of the membrane elements; speciation © 2003 by Marcel Dekker, Inc.

of the components of TDS—sulfate, chloride, sodium, etc.; among others). From the standpoint of normal daily operation, however, we may not need to measure all the anions and cations that comprise TDS. The decision as to which parameters should be included on an in-plant testing protocol will vary with the type of industry, the speciﬁc application of the process, an assessment of the potential risks associated with a process or product, hazard analysis and critical control point (HACCP) evaluation, the presiding regulations and guidelines that apply, and the company’s own internal mandates. D.

Testing to Incorporate Individual Company Requirements

This category is often a hybrid of the other testing categories included in this section. The testing may be driven by regulatory mandates or voluntary ascription to impending regulatory trends; historical lessons learned; product- or process-speciﬁc testing (e.g., individual stability or sensory standards, consumer-driven requirements, etc.); and, parameters that may affect plant efﬂuent treatment (e.g., pH, TDS, biochemical oxygen demand, etc.) Most of the points mentioned are self-explanatory, but in the author’s experience the historical lessons category is often the most worthwhile when it comes to monitoring parameters of importance. Every food and beverage company must be replete with anecdotes, for example, perhaps from a Principal Scientist with 40 years of corporate tenure, which describe problems that occurred decades ago. Though some might scoff at these war stories, most will admit that there is empirical validity to the adage those who do not learn from their mistakes are destined to repeat them. E.

Troubleshooting

This category may be the most encompassing of all and cannot be distilled to a few concise guidelines. The testing performed as a result of a troubleshooting exercise is often not planned; is often forcibly undertaken under the threat of an impending plant shut down; may potentially mean the difference between a minor, easily remedied plant operations issue and a serious breach which warrants a product recall; and must always be performed in a scientiﬁc, methodical fashion to maintain the integrity of the data and the value of the conclusions which will be drawn. As we continue to develop the ability to detect compounds at lower levels than ever thought possible, we must also face the reality that we will undoubtedly ﬁnd them in many of the places we look. As contaminants move more toward ubiquity, this makes the thoughtful development of appropriate testing protocols, acquisition of accurate and precise data, formulation of valid conclusions, and data-based action plans key to the future success of food, beverage, pharmaceutical, and municipal water treatment industries. REFERENCES 1. FG Driscoll. Groundwater and Wells, 2nd Ed. St. Paul, MN: Johnson Filtration Systems, 1986, pp 53–58. 2. CD Morelli. Water Manual, 2nd Ed. New York: Beverage World Publishers, 1990, p 3. 3. RL Nace. Scientiﬁc framework of world water balance. UNESCO Tech Papers Hydrol 7, 1971, p 27. 4. DA Okun. Global water supply issues from a public health perspective. In: G Craun, ed. Safety of Water Disinfection: Balancing Chemical and Microbial Risks. Washington, DC: ILSI Press, 1993, pp 31–38.

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5. World Water Conference, Hague, 2000. 6. AWWA. Introduction to water sources and transmission, Vol 1. Denver, CO: American Water Works Association, 1985, pp 2–25. 7. RW Cleary. Syllabus to the Princeton course in groundwater pollution and hydrology, 1994, pp 1–23. 8. EPA. EPA/625/R-93/002 Wellhead protection: a guide for small communities. Cincinnati, OH: U.S. Environmental Protection Agency Ofﬁce of Research and Development, 1993. 9. EPA. EPA/570/9–91/009. Cincinnati, OH: U.S. Environmental Protection Agency Ofﬁce of Research and Development, 1991. 10. EPA. Title 40, Code of Federal Regulations, Part 141, National Primary Drinking Water Regulations. Washington, DC: U.S. Government Printing Ofﬁce, 1999. 11. EPA. Title 40, Code of Federal Regulations, Part 143, National Secondary Drinking Water Regulations. Washington, DC: U.S. Government Printing Ofﬁce, 1999. 12. EU. Council directive 98/83/EC on the quality of water intended for human consumption. OJ L330, 32, 1998. 13. WHO. Guidelines for Drinking Water Quality, 2nd Ed. Vol 1: Recommendations. Geneva: World Health Organization, 1993. 14. WHO. Guidelines for Drinking Water Quality, 2nd Ed. Addendum to Vol. 1: Recommendations. Geneva: World Health Organization, 1998. 15. PJ Brittan. Integrating conventional and membrane water treating systems. International Society of Beverage Technologists short course for beverage production, Ft. Lauderdale, Florida, 1997. 16. JM Symons, LC Bradley, T Cleveland. The Drinking Water Dicitonary. Denver, CO: American Water Works Association, 2000. 17. JM Symons, LC Bradley, T Cleveland. The Drinking Water Dicitonary. Denver, CO: American Water Works Association, 2000. 18. Bulletin NA-58. Over 150 varieties of activated carbon and here’s why. Atlanta, GA: Norit Americas, Inc., 1998, p 10. 19. J Mallevialle, IH Suffet. Identiﬁcation and treatment of tastes and odors in drinking water: cooperative research report. Denver, CO: American Water Works Research Foundation and Lyonnaise des Eaux Dumez, 1987. 20. AWWA. Manual of Water Supply Practices (M48): Waterborne Pathogens. Denver, CO: American Water Works Association, 1999, pp 75–80. 21. Cryptosporidium and Water: A Public Health Handbook. Atlanta, GA: Working Group on Waterborne Cryptosporidiosis, Centers for Disease Control, 1997. 22. AWWA. Manual of Water Supply Practices (M7), Problem Organisms in Water: Identiﬁcation and Treatment, 2nd ed. Denver, CO: American Water Works Association, 1995, pp 7–31. 23. GF Connell. The Chlorination/Chloramination Handbook, Water Disinfection Series. Denver, CO: American Water Works Association, 1996, p 26. 24. C Nebel. Ozone treatment of beverage water. Proc ISBT, pp 45–55, 1981. 25. R Rice. Applications of ozone in soft drink bottling plants. Proc ISBT, pp 181–221, 1987. 26. B Langlais, D Reckhow, D Brink. Ozone in Water Treatment: Application and Engineering, Cooperative Research Report. Denver, CO: American Water Works Association and Compagnie Generale des Eaux, 1991. 27. JC Hoff. Strengths and weaknesses of using CT values to evaluate disinfection practice. Proc AWWA Seminar, pp 49–60, 1987. 28. IBWA. Plant Technical Manual, Water Treatment and Processing. Alexandria, VA: International Bottled Water Association, 1995, p 57. 29. EPA. EPA/815R-99 Alternative Disinfectants and Oxidants Guidance Manual. Washington, DC: United States Environmental Protection Agncy Ofﬁce of Water, 1999. 30. Z Bukhari, T Hargy, J Bolton, B Dussert, J Clancy. Medium-pressure UV for oocyst inactivation. JAWWA 91(3):86–94, 1999.

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31. F Kemmer. The Nalco Water Handbook. New York: McGraw-Hill, 1988. 32. WA Telliard. New Ofﬁce of Water methods for compliance monitoring programs (unpublished internal presentation). Washington, DC: U.S. Environmental Protection Agency, 1998. 33. ASTM. Standard Practice for Environmental Site Assessments. Phase I: Environmental Site Assessment Process. N. E 1527-93. Washington, DC: American Society for Testing and Materials, 1993. 34. WA Telliard. Streamlining implementation—next steps (unpublished internal presentation). Washington, DC: U.S. Environmental Protection Agency, 1998. 35. AWWA. Manual of Water Supply Practices (M21): Groundwater. Denver, CO: American Water Works Association, 1989, pp 1–25. 36. Pepsi-Cola Corporate Training Manual. Water Quality Tool, Membrane Treatment Module, 2001, pp 36–37. 37. J Lister. Berkefeld Water Treatment Applications for the Beverage Industry (unpublished internal presentation). Toronto, Canada, 2001. 38. Pepsi-Cola Corporate Training Manual. Water Quality Tool, Ion-Exchange Module, 2001, pp 53–54. 39. D McCarty. UV Applications in Beverage Water Treatment (internal presentation), Erlanger, KY, 2001.

© 2003 by Marcel Dekker, Inc.

13 Sanitation of Food Processing Equipment PEGGY STANFIELD Dietetic Resources, Twin Falls, Idaho, U.S.A.

I.

GENERAL CONSIDERATIONS

The information in this chapter has been derived from the following sources: 1. Food and Drug Administration (FDA) documents: Code of Federal Regulations, current good manufacturing practices (CGMPs), the Food Code, hazard analysis and critical control point (HACCP) programs; 2. U.S. Department of Agriculture (USDA) documents: Code of Federal Regulations, HACCP programs, inspection manuals, directives, etc.; 3. Recommendations developed and distributed by major trade associations representing food, warehousing, and transport and related industries. Food processing equipment used in all food plants (meat and nonmeat) is ‘‘predetermined’’ under usual circumstances: 1. Mandatory speciﬁcations. Most of those used in processing low-acid (acidiﬁed, etc.) foods in hermetically sealed containers (thermal processing) and meat and poultry products are directly regulated by regulations promulgated by the FDA and USDA in relation to safety and sanitation. 2. New establishments. Newly constructed establishments should take into consideration all aspects of good manufacturing practices before their construction or equipment purchases. 3. Most specialty equipment (for bakery, dairy, pasta, oil, etc.) is under voluntary/ mandatory requirements established and distributed by trade associations such as the American Institute of Baking, Dairy and Food Industries Supply Associa© 2003 by Marcel Dekker, Inc.

4. 5.

6.

7.

tion, American Oil Chemical Society, and the National Sanitation Foundation. Again, such equipment is in compliance with FDA/USDA GMPs, provided that all instructions relating to maintenance and repair are adhered to. With built-in designs to comply with FDA/USDA GMPs, this equipment saves food processors time and money in looking for the ‘‘right’’ equipment. Custom-made equipment. Plant personnel may build their own equipment or have an outside contractor fabricate equipment for them. Even though it is custom made and not intended for resale, such equipment should be built to comply with good manufacturing practices. The same standards are applicable to custom-made equipment as are applicable to commercially available equipment. Many food processing plants require some equipment that is custom made for particular operational requirements. It may not be possible to comply with certain good manufacturing practices in the same way as other conventional equipment. If so, it is always advisable to inform the appropriate state and federal regulators of the circumstances. All other food processing equipment that is commercially available.

The bottom line is that all food processing equipment, no matter how they are predetermined, must comply with FDA, USDA, and state GMP guidelines. Some equipment manufacturers or brokers are sometimes not interested in complying with FDA/USDA GMP. In such events, equipment is considered the same as custom made, and food establishment operators should be aware of this responsibility before they purchase any equipment. All food processors using a variety of equipment, especially custom-made equipment, should focus on correcting problems during the initial development of equipment instead of resolving problems which may result when improperly designed or constructed equipment is put into widespread use. This preventive mode of action beneﬁts equipment manufacturers, food processors, state and federal regulators, and American consumers. In general, the following basic and standard equipment is usually considered to comply with good manufacturing practice or their compliance is of minor signiﬁcance: Simple hand tools Equipment used to prepare packaging materials Equipment used on fully packaged product Equipment used on operations involving inedible products that will not be mixed with edible ones Central cleaning system Utensil and equipment cleaning machinery Pails, buckets, etc. Pallets for packaged product Picking ﬁngers Tanks for fully ﬁnished oils Simple can openers Chutes, ﬂumes, hangback racks, supporting stands, and brackets Vegetable cleaning equipment (not applicable to spin-type washers/dryers) Insect control units Shipping containers Pressure storage vessels for refrigerants (not applicable to CO2 snow-making equipment) © 2003 by Marcel Dekker, Inc.

Water softeners, water heaters, water meters, and chemical dispensers Can and jar washers/cleaners Mixing equipment Hot air shrink tunnels Air and water ﬁlters Devices for measuring physical characteristics (temperature, pressure, etc.) Rubber ﬂoor mats The product contact areas of this equipment must be made up of approved materials. II. MATERIALS FOR CONSTRUCTION AND REPAIR A. Characteristics Materials that are used in the construction of utensils and food-contact surfaces of equipment may not allow the migration of deleterious substances or impart colors, odors, or tastes to food, and under normal use conditions these should be Safe Durable, corrosion resistant, and nonabsorbent Sufﬁcient in weight and thickness to withstand repeated warewashing Finished to have a smooth, easily cleanable surface Resistant to pitting, chipping, crazing, scratching, scoring, distortion, and decomposition Multi-use equipment is subject to deterioration because of its nature, i.e., intended use over an extended period of time. Certain materials allow harmful chemicals to be transferred to the food being prepared, which could lead to foodborne illness. In addition, some materials can affect the taste of the food being prepared. Surfaces that are unable to be routinely cleaned and sanitized because the materials used could harbor foodborne pathogens. Deterioration of the surfaces of equipment, such as pitting, may inhibit adequate cleaning of the surfaces of equipment, so that food prepared on or in the equipment becomes contaminated. Inability to effectively wash, rinse, and sanitize the surfaces of food equipment may lead to the build-up of pathogenic organisms transmissible through food. Studies regarding the rigor required to remove bioﬁlms from smooth surfaces highlight the need for materials of optimal quality in multi-use equipment. It must be emphasized that each food processing operation is unique, which applies to the equipment used. The acceptability and nonacceptability of any food processing equipment or its component materials occasionally depends on the operation itself. This must be taken into consideration when evaluating an item of equipment in relation to the GMP. B. Cast Iron Cast iron is an alloy of iron and heavy metals which may leach into food if left in contact with acidic foods for extended periods of time. Heavy metal poisoning has resulted from such situations. The temporary or incidental contact that results from using cast iron as a cooking surface and for dispensing utensils used as part of an uninterrupted, short-term process is acceptable because of the brief contact time involved. Use limitations are as follows: © 2003 by Marcel Dekker, Inc.

1. 2. 3.

C.

In general, cast iron may not be used for utensils or food-contact surfaces of equipment. It may be used as a surface for cooking. It may be used in utensils for serving food if the utensils are used only as part of an uninterrupted process from cooking through service.

Some Acceptable Materials

Equipment should be constructed of materials that will not deteriorate from normal use under the anticipated environment. For example, equipment must be constructed of materials that will withstand one category of environment, e.g., generally humid operating environment and high pressure, hot water cleaning with strong chemical cleaning agents. Of course, there are other categories of food processing environments. In addition, all equipment surfaces should be smooth, corrosion and abrasion resistant, shatterproof, nontoxic, nonabsorbent, and not capable of migrating into food product (staining). The following lists some acceptable food processing equipment and/or their component materials. 1. The Series 300 (18-8) Stainless Steel The Series 300 (18-8) stainless steel is acceptable for general use. Other series have been used for construction of food equipment, but their use is limited because they tend to rust or discolor in certain applications. The abbreviation S/S is used throughout this chapter to denote stainless steel construction. 2. Aluminum Aluminum may pit and corrode when exposed to certain chemicals. When friction occurs between aluminum and fats, a black oxide is produced which discolors the product. Anodizing the aluminum does not eliminate this problem. Therefore, the use of aluminum is limited to applications where the metal does not contact the product or in which the product is suspended in water. 3. Surface Coatings and Platings Surface coatings and platings may be used if the base material is nontoxic and rendered noncorrosive and the plating material is USDA/FDA acceptable. Chrome, nickel, tin, and zinc (galvanization) platings will generally be acceptable for most appropriate applications. Clearance of other plating materials and processes can be obtained by receiving a favorable opinion for the intended use from the FDA, Ofﬁce of Premarket Approval. Surface coatings and platings must remain intact. If a surface coating or plating begins to peel or crack, the FDA/USDA inspection will request correction from the management and may even disallow the use of the equipment. 4. Hardwood Hardwood may be used for dry curing, In addition, solid (unlaminated) pieces of hardwood are acceptable as removable cutting boards provided the wood is maintained in a smooth, sound condition and is free from cracks. Hardwood cutting boards must be of the shortest dimension which is practical, preferably not exceeding 3 or 4 ft (0.91 or 1.22 m). © 2003 by Marcel Dekker, Inc.

D. Some Unacceptable Materials Cadmium, antimony, and lead are toxic materials that cannot be used as materials of construction, either as a plating or the plated base material. Lead, however, may be used in acceptable alloys in an amount not exceeding 5%. Enamelware and porcelain are not acceptable for handling and processing food product unless a food plant management provides reasons why they are needed. Copper, bronze, and brass are not acceptable for direct product contact. These materials may be used in air and water lines or for gears and bushings outside the product zone. Brass is acceptable for potable water systems and direct contact with brine, but not for brine, or any solution, that is recirculated. Leather and fabric are not acceptable materials unless a food plant management provides reasons why they are needed. E.

Non–Food-Contact Surfaces

Non–food-contact surfaces of equipment that are exposed to splash, spillage, or other food soiling or that require frequent cleaning should be constructed of a corrosion-resistant, nonabsorbent, and smooth material. Non–food-contact surfaces of equipment routinely exposed to splash or food debris are required to be constructed of nonabsorbent materials to facilitate cleaning. Equipment that is easily cleaned minimizes the presence of pathogenic organisms, moisture, and debris and deters the attraction of rodents and insects. III. DESIGN AND CONSTRUCTION A. Durability and Strength 1. Equipment and Utensils Equipment and utensils should be designed and constructed to be durable and to retain their characteristic qualities under normal use conditions. Equipment should be designed so that all product contact surfaces can be readily and thoroughly cleaned with high temperature/high pressure water and caustic soap solution. Components such as electric motors, electric components, etc., which cannot be cleaned in this manner should be completely enclosed and sealed. Other considerations are All product contact surfaces should be visible (or easily made visible) for inspection. All product contact surfaces should be smooth and maintained free of pits, crevices, and scale. The product zone should be free of recesses, open seams, gaps, protruding ledges, inside threads, inside shoulders, bolts, rivets, and dead ends. Bearings (including greaseless bearings) should not be located in or above the product zone. In addition, bearings should be constructed so that lubricants will not leak or drip or be forced into the product zone. Internal corners or angles in the product zone should have a smooth and continuous radius of 0.25 in. (6.35 mm) or greater. (Lesser radii may be used for proper functioning of parts or to facilitate drainage, provided these areas can be readily cleaned.) © 2003 by Marcel Dekker, Inc.

Equipment should be self-draining or designed to be evacuated of water. Framework of equipment (if not completely enclosed and sealed) should be designed to use as few horizonal frame members as possible. Furthermore, these components should be rounded or of tubular construction. Angle is not acceptable except as motor supports. Equipment should be designed, constructed, and installed in a manner to protect personnel from safety hazards such as sharp edges, moving parts, electric shocks, excessive noise, and any other hazards. Safety guards should be removable for cleaning and inspection purposes. All welds, in both product- and non–product-contact areas, should be smooth, continuous, even, and relatively ﬂush with the adjacent surfaces. Equipment should not be painted on areas which are in or above the product zone. External surfaces should not have open seams, gaps, crevices, or inaccessible recesses. Where parts must be retained by nuts or bolts, ﬁxed studs with wing nuts should be used instead of screws to a tapped hole. Gasketing, packing materials, O rings, etc., must be nontoxic, nonporous, nonabsorbent, and unaffected by food products and cleaning compounds. Equipment and utensils must be designed and constructed to be durable and capable of retaining their original characteristics so that such items can continue to fulﬁll their intended purpose for the duration of their life expectancy and to maintain their easy cleanability. If they cannot maintain their original characteristics, they may become difﬁcult to clean, allowing for the harborage of pathogenic microorganisms, insects, and rodents. Equipment and utensils must be designed and constructed so that parts do not break and end up in food as foreign objects or present injury hazards to consumers. A common example of presenting an injury hazard is the tendency for tines of poorly designed single service forks to break during use. 2. Food Temperature Measuring Devices Food temperature measuring devices may not have sensors or stems constructed of glass, except that thermometers with glass sensors or stems that are encased in a shatterproof coating such as candy thermometers may be used. Food temperature measuring devices that have glass sensors or stems present a likelihood that glass will end up in food as a foreign object and create an injury hazard to the consumer. In addition, the contents of the temperature measuring device, e.g., mercury, may contaminate food or utensils. B.

Cleanability

1. Food-Contact Surfaces Multi-use food-contact surfaces should be Smooth Free or breaks, open seams, cracks, chips, pits, and similar imperfections Free of sharp internal angles, corners, and crevices Finished to have smooth welds and joints Accessible for cleaning and inspection by one of the following methods: Without being disassembled © 2003 by Marcel Dekker, Inc.

By disassembling without the use of tools By easy disassembling with the use of only simple tools such as mallets, screwdrivers, or wrenches that are kept near the equipment and are accessible for use The purpose of the requirements for multi-use food-contact surfaces is to assure that such surfaces are capable of being easily cleaned and accessible for cleaning. Food-contact surfaces that do not meet these requirements provide a potential harbor for foodborne pathogenic organisms. Surfaces which have imperfections such as cracks, chips, or pits allow microorganisms to attach and form bioﬁlms. Once established, these bioﬁlms can release pathogens to food. Bioﬁlms are highly resistant to cleaning and sanitizing efforts. The requirement for easy disassembly recognizes the reluctance of food employees to disassemble and clean equipment if the task is difﬁcult or requires the use of special, complicated tools. 2. Clean-In-Place Systems Clean-in-place (CIP) is deﬁned as follows: CIP means cleaned in place by the circulation or ﬂowing by mechanical means through a piping system of a detergent solution, water rinse, and sanitizing solution onto or over equipment surfaces that require cleaning, such as the method used, in part, to clean and sanitize a frozen dessert machine. CIP does not include the cleaning of equipment such as band saws, slicers, or mixers that are subjected to in-place manual cleaning without the use of a CIP system. Sanitation procedures for CIP systems must be as effective as those for cleaning and sanitizing disassembled equipment. Only equipment that meets the following criteria may be cleaned in place. Any equipment or portions of equipment not meeting these requirements should be disassembled for daily cleaning and inspection. CIP equipment should meet the characteristics as speciﬁed. Cleaning solutions, sanitizing solutions, and rinse water should circulate throughout a ﬁxed system and contact all interior surfaces of the system. All internal surfaces should be either designed for self-draining (of cleaning and sanitizing solutions) or physically disassembled for draining after rinsing. CIP equipment that is not designed to be disassembled for cleaning should be designed with inspection access points to assure that all interior food-contact surfaces throughout the ﬁxed system are being effectively cleaned. Pipe interiors should be highly polished (120–180 grit abrasive) stainless steel or some other acceptable, smooth surfaced material which is easy to inspect. Easily removable elbows with quick-disconnect mechanisms should be located at each change of direction. All sections of the system should be capable of being completely disassembled for periodic inspection of all internal surfaces. All sections should be available for inspection without posing any safety hazard to the inspector. Certain types of equipment are designed to be cleaned in place where it is difﬁcult or impractical to disassemble the equipment for cleaning. Because of the closed nature © 2003 by Marcel Dekker, Inc.

of the system, CIP cleaning must be monitored via access points to assure that cleaning has been effective thoughout the system. The CIP design must assure that all food-contact surfaces of the equipment are contacted by the circulating cleaning and sanitizing solutions. Dead spots in the system, i.e., areas which are not contacted by the cleaning and sanitizing solutions, could result in the build-up of food debris and growth of pathogenic microorganisms. There is equal concern that cleaning and sanitizing solutions might be retained in the system, which may result in the inadvertent adulteration of food. Therefore, the CIP system must be selfdraining. 3. V Threads V-type threads may not be used on food-contact surfaces. This section does not apply to hot oil cooking or ﬁltering equipment. V-type threads present a surface which is difﬁcult to clean routinely; therefore, they are not allowed on food-contact surfaces. The exception provided for hot oil cooking fryers and ﬁltering systems is based on the high temperatures that are used in this equipment. The high temperature in effect sterilizes the equipment, including debris in the V threads. 4. Hot Oil Filtering Equipment Hot oil ﬁltering equipment should meet the characteristics of cleanability and should be readily accessible for ﬁlter replacement and cleaning of the ﬁlter. To facilitate and assure effective cleaning of this equipment, cleanability requirements must be followed. The ﬁlter is designed to keep the oil free of undesired materials and therefore must be readily accessible for replacement. Filtering the oil reduces the likelihood that off-odors, tastes, and possibly toxic compounds may be imparted to food as a result of debris build-up. To assure that ﬁltering occurs, it is necessary for the ﬁlter to be accessible for replacement. 5. Can Openers Cutting or piercing parts of can openers should be readily removable for cleaning and for replacement. Once can openers become pitted or the surface in any way becomes uncleanable, they must be replaced because they can no longer be adequately cleaned and sanitized. Can openers must be designed to facilitate replacement. 6. Non–Food-Contact Surfaces Non–food-contact surfaces should be free of unnecessary ledges, projections, and crevices and be designed and constructed to allow easy cleaning and to facilitate maintenance. Hard-to-clean areas could result in the attraction and harborage of insects and rodents and allow the growth of foodborne pathogenic microorganisms. Well-designed equipment enhances the ability to keep non–food-contact surfaces clean. 7. Kick Plates Kick plates should be designed so that the areas behind them are accessible for inspection and cleaning by being (1) removable by one of the methods speciﬁed under cleanability or capable of being rotated open and (2) removable or capable of being rotated without unlocking equipment doors. The use of kick plates is required to allow access for proper cleaning. If kick plate design and installation does not meet these requirements, debris could accumulate and create a situation that may attract insects and rodents. © 2003 by Marcel Dekker, Inc.

C. Accuracy 1. Food Temperature Measuring Devices The Metric Conversion Act of 1975 (amended in 1988) requires that all federal government regulations use the Celsius scale for temperature measurement. The Fahrenheit scale is included here for all other sectors of the country using Fahrenheit equivalents. The Fahrenheit equivalent will also help those jurisdictions that require Celsius readings to make the transition from Fahrenheit. Since 1°C is equivalent to approximately 2°F (1.8°F), an accuracy of ⫾1°C is required. Food temperature measuring devices that are scaled only in Celsius or dually scaled in Celsius and Fahrenheit should be accurate to ⫾1°C (1.8°F). Food temperature measuring devices that are scaled only in Fahrenheit should be accurate to ⫾2°F. The small margin of error speciﬁed for thermometer accuracy is due to the lack of a large safety margin in the temperature requirements themselves. The requirement for Fahrenheit thermometers to be accurate to 2°F is due to the lack of 1 degree increment scaling in Fahrenheit thermometers currently being used, such as the metal stem thermometer. 2. Ambient Temperature Measuring Devices A temperature measuring device used to measure the air temperature in a refrigeration unit is not required to be as accurate as a food thermometer because the unit’s temperature ﬂuctuates with repeated opening and closing of the door and because accuracy in measuring internal food temperatures is of more signiﬁcance. Ambient temperature measuring devices that are scaled in Celsius or dually scaled in Celsius and Fahrenheit should be designed to be easily readable and accurate to ⫾1.5°C (2.7°F) at the use range. Ambient temperature measuring devices that are scaled only in Fahrenheit should be accurate to ⫾3°F at the use range. The Celsius scale is the federally recognized scale based on The Metric Conversion Act of 1975 (amended in 1988), which requires the use of metric values. The ⫾1.5°C requirement is more stringent than the 3°F previously required since ⫾1.5°C is equivalent to ⫾2.7°F. The more rigid accuracy results from the practical application of metric equivalents to the temperature gradations of Celsius thermometers. If Fahrenheit thermometers are used, the ⫾3°F requirement applies because of the calibrated intervals of Fahrenheit thermometers. IV. FUNCTIONALITY, DESIGN, AND CONSTRUCTION A. Ventilation Hood Systems Exhaust ventilation hood systems in food preparation and warewashing areas including components such as hoods, fans, guards, and ducting should be designed to prevent grease or condensation from draining or dripping onto food, equipment, utensils, linens, and single-service and single-use articles. The dripping of grease or condensation onto food constitutes adulteration and may involve contamination of the food with pathogenic organisms. Equipment, utensils, linens, © 2003 by Marcel Dekker, Inc.

and single-service and single-use articles that are subjected to such drippage are no longer clean. B.

Equipment Openings

Equipment openings and covers must be designed to protect stored or prepared food from contaminants and foreign matter that may fall into the food. The requirement for an opening to be ﬂanged upward and for the cover to overlap the opening and be sloped to drain prevents contaminants, especially liquids, from entering the food-contact area. 1. 2. 3.

4.

A cover or lid for equipment should overlap the opening and be sloped to drain. An opening located within the top of a unit of equipment that is designed for use with a cover or lid should be ﬂanged upward at least 5 mm (0.2 in.). Fixed piping, temperature measuring devices, rotary shafts, and other parts extending into equipment should be provided with a watertight joint at the point where the item enters the equipment. This assumes that a watertight joint is not provided. If a watertight joint is not provided: a. The piping, temperature measuring devices, rotary shafts, and other parts extending through the openings should be equipped with an apron designed to deﬂect condensation, drips, and dust from food openings. b. The opening should be ﬂanged (see item 2).

Some equipment may have parts that extend into the food-contact areas. If these parts are not provided with a watertight joint at the point of entry into the food-contact area, liquids may contaminate the food by adhering to shafts or other parts and running or dripping into the food. An apron on parts extending into the food-contact area is an acceptable alternative to the watertight seal. If the apron is not properly designed and installed, condensation, drips, and dust may gain access to the food. 1. Bearings and Gear Boxes Equipment containing bearings and gears that require lubricants should be designed and constructed so that the lubricant cannot leak, drip, or be forced into food or onto foodcontact surfaces. It is not unusual for food equipment to contain bearings and gears. Lubricants necessary for the operation of these types of equipment could contaminate food or food-contact surfaces if the equipment is not properly designed and constructed. 2. Condenser Unit If a condenser unit is an integral component of equipment, the condenser unit should be separated from the food and food storage space by a dust-proof barrier. A dust-proof barrier between a condenser and food storage areas of equipment protects food and foodcontact areas from contamination by dust that is accumulated and blown about as a result of the condenser’s operation. 3. Temperature Measuring Devices Requirements are as follows: 1.

In a temperature-regulated storage unit (cool for refrigerator or warm/hot storage room/equipment), the sensor of a temperature measuring device should be

© 2003 by Marcel Dekker, Inc.

2.

3.

4. 5.

located to measure the air temperature in the warmest part of a mechanically refrigerated unit and in the coolest part of the storage unit. Cold or hot holding equipment used for edible products should be equipped with at least one integral or permanently afﬁxed temperature measuring device that is located to allow easy viewing of the device’s temperature display. There are exceptions. Item 2 does not apply to equipment for which the placement of a temperature measuring device is not a practical means for measuring the ambient air surrounding the edible product because of the design, type, and use of the equipment, such as calrod units, heat lamps, cold plates, bainmaries, steam tables, insulated food transport containers, and salad bars. Temperature measuring devices should be designed to be easily readable. Food temperature measuring devices should have a numerical scale, printed record, or digital readout in increments no greater than 1°C or 2°F.

The placement of the temperature measuring device is important. If the device is placed in the coldest location in the storage unit, it may not be representative of the temperture of the unit. Food could be stored in areas of the unit that exceed requirements. Therefore, the temperature measuring device must be placed in a location that is representative of the actual storage temperature of the unit to assure that all potentially hazardous foods are stored at least at the minimum temperature required for the speciﬁed food. A permanent temperature measuring device is required in any unit storing potentially hazardous food because of the potential growth of pathogenic microorganisms should the temperature of the unit exceed requirements. In order to facilitate routine monitoring of the unit, the device must be clearly visible. The exception to requiring a temperature measuring device for the types of equipment listed is primarily due to equipment design and function. It would be difﬁcult and impractical to permanently mount a temperature measuring device on the equipment listed. The futility of attempting to measure the temperature of unconﬁned air such as with heat lamps and, in some cases, the brief period of time the equipment is used for a given food negate the usefulness of ambient temperature monitoring at that point. In such cases, it would be more practical and accurate to measure the internal temperature of the food. The importance of maintaining potentially hazardous foods at the speciﬁed temperatures requires that temperature measuring devices be easily readable. The inability to accurately read a thermometer could result in food being held at unsafe temperatures. Temperature measuring devices must be appropriately scaled per stated requirements to assure accurate readings. The required incremental gradations are more precise for food measuring devices than for those used to measure ambient temperature because of the signiﬁcance at a given point in time, i.e., the potential for pathogenic growth, versus the unit’s temperature. The food temperature will not necessarily match the ambient temperature of the storage unit; it will depend on many variables including the temperature of the food when it is placed in the unit, the temperature at which the unit is maintained, and the length of time the food is stored in the unit. 4. Case Lot Handling Equipment Equipment such as dollies, pallets, racks, and skids used to store and transport large quantities of packaged foods received from a supplier in a cased or overwrapped lot should be designed to be moved by hand or by conveniently available equipment such as hand trucks © 2003 by Marcel Dekker, Inc.

and forklifts. Proper design of case lot handling equipment facilitates moving case lots for cleaning and for surveillance of insect or rodent activity. V.

WATER USAGE

A.

Water Wasting Equipment

Water wasting equipment should be installed so that wastewater is delivered into the drainage system through an interrupted connection without ﬂowing over the ﬂoor or is discharged into a properly drained curbed area. Waste water from cooking tanks, soaking tanks, chilling tanks, and other large vessels may be discharged for short distances across the ﬂoor to a drain after operations have ceased and all product has been removed from the area. B.

Protection of Water Supply

An air gap should be provided between the highest possible level of liquids in equipment and a directly connected water supply line(s). The air gap must be at least twice the diameter of the supply side oriﬁce. If submerged lines are unavoidable due to design considerations, then the equipment must include a functional vacuum breaker which will, without fail, break the connection in the event of water pressure loss. C.

Recirculation of Water

Equipment which recirculates water as part of its intended function should be equipped with sanitary recirculating components if the water directly or indirectly contacts food product or the product contact surfaces. For example, recirculating pumps should be accepted for direct product contact and piping must be easily demountable with quick disconnect mechanisms at each change of direction. In addition, establishment operators using equipment or systems which reuse water may be required to have written approval of a water reuse procedure. However, the requirement is mandatory for meat and poultry processors by the USDA. Although the FDA does not require a written approval at this stage, its GMP regulations make it clear that there must be built-in safeguards in the reuse of water in a food plant. D.

Valves

Valves on drainage outlets should be easily demountable to the extent necessary for thorough cleaning. Overﬂow pipes should be constructed so that all internal and external surfaces can be thoroughly cleaned. VI. OTHER EQUIPMENT A.

Piping Systems

Piping systems used to convey edible product (including pickle solutions) should be readily disassembled for cleaning and inspection. Pumps, valves, and other such components should comply with the sanitary requirements of good manufacturing practices promulgated by USDA/FDA. Piping systems must be designed so that product ﬂow will © 2003 by Marcel Dekker, Inc.

be smooth and continuous, i.e., no traps or dead ends. Pipes must be either 300 series stainless steel or a USDA/FDA acceptable plastic. Clear demountable rigid plastic piping may be used for two-way ﬂow provided it is chemically and functionally acceptable. Opaque plastic piping may be used for oneway purposes only. The cited requirements apply to systems for conveying raw fat and to recirculate cooking and frying oils. Black iron pipes with threaded or welded joints are acceptable for conveying completely ﬁnished, rendered fats. Continuous rendering is not considered complete until after the ﬁnal centrifuge. Pipeline conveying systems for aseptic processing and packaging should comply with the requirements promulgated by the FDA and USDA in the U.S. Code of Federal Regulations. B. Magnetic Traps and Metal Detectors The extensive exposure of some products to metal equipment such as grinders, choppers, mixers, shovels, etc., causes the possibility of metal contamination. Magnetic traps have been found effective in removing iron particles from chopped or semiliquid products. However, these magnetic traps are not useful for removing nonmagnetic metals such as stainless steel or aluminum. Therefore, the use of electronic metal detectors is highly recommended for sausage emulsions, can ﬁlling lines (especially baby foods), etc. Metal detectors are usually installed so an alarm (either a bell or light or both) is activated when a metal fragment is in the detection zone. The production line should stop automatically when the detector is activated. Alternatively, some systems are arranged so that the portion of the product containing the metal contaminant(s) is automatically removed from the production line. The FDA and USDA do not currently regulate the use of metal detectors for normal production. The agencies do encourage food plant operators to voluntarily use metal detectors whenever possible. The agencies review and evaluate metal detectors using the same sanitary standards applied to other types of equipment. The sensitivity and reliability of metal detectors varies depending on aperture size, type of food product, frequency and method of calibration, and numerous other variables. Since many of the involved factors are not related to the design of the unit itself, the agencies do not currently classify metal detectors. However, the following classiﬁcation standard is offered on a voluntary basis. Classiﬁcationa

Spherical diameter

Type of metal

A B C Db

1/32 in. (0.794 mm) 1/16 in. (1.588 mm) 1/8 in. (3.175 mm)

316 stainless 316 stainless 316 stainless

a

To test a metal detector, a metal sphere of the size and type indicated (generally imbedded in an acceptable, non-metallic materials) is passed through the center of the aperture. The detector must detect in at least nine of the ten passes through to qualify for the applicable classiﬁcation. b The D classiﬁcation identiﬁes those detectors which are either not sensitive to the 1/8 in. (3.175 mm) level or are installed in a manner that prevents testing in the described fashion.

© 2003 by Marcel Dekker, Inc.

C.

Conveyor Belts

Conveyor belts used in direct contact with food product must be moisture resistant and nonabsorbent. Conveyor belts should have the edges sealed with the same material as is used for the food-contact surface. In addition, belting material must be chemically acceptable and approved by the FDA/USDA. Conveyors with troughlike sides and bed should have a quick belt tension release device to allow cleaning under the belt. D.

Jet-Vacuum Equipment

Equipment used for cleaning jars or cans should have safety devices to indicate malfunction of either jet or vacuum elements. If necessary, vents to the outside should be provided to control exhaust currents and to prevent dust and/or paper particles from being blown back into cleaned containers. E.

Hoses

Hoses used for product contact should comply with recommendations of trade associations or be accepted by both the FDA/USDA. The hose material must be installed in a manner that allows for inspection of the interior surface. Sanitary connectors can be installed at appropriate intervals to allow breakdown for visual inspection or use of inspection devices such as boroscopes. Hoses without sanitary connectors are acceptable for steam and water lines where breakdown for cleaning and inspection is not necessary. However, hoses used for recirculating water into and out of product contact areas must satisfy the requirement for product contact hoses. F.

Pickle Lines

Pickle lines should be either stainless steel or some other USDA acceptable material. If recirculated, pickle brine should be ﬁltered and recirculated through a system that can be disassembled to the extent necessary for thorough cleaning and inspection. G.

Smokehouses and Ovens

Smokehouses and ovens must be designed for easy cleaning and inspection of all inner and outer surfaces. Ducts should be designed to be easily disassembled to the extent necessary for thorough cleaning and inspection. Spray heads for dispensing liquid smoke must be mounted below the level of the rails and trolleys. If liquid smoke is to be recirculated, the pump and pipelines must be of sanitary type construction. Liquid smoke cannot be recirculated if product is on rack trucks. H.

Screens and Filters

Screens and straining devices should be readily removable for cleaning and inspection and should be designed to prevent incorrect installation. Permanent screens should be constructed of noncorrosive metals. Synthetic ﬁlter materials should have clearance from trade associations. The same applies to ﬁlters intended for direct product contact. Filter paper should be single service. Filter cloths should be washable. Asbestos is not acceptable for use as ﬁltering material or for any other purpose. © 2003 by Marcel Dekker, Inc.

I.

Vent Stacks from Hoods

Vent stacks from covered cooking vats or hoods over cook tanks and CO2 equipment should be arranged or constructed so as to prevent drainage of condensate back into the product zone. J. Ultraviolet Lamps Ultraviolet (UV) lamps which generate ozone are restricted for use as described under ‘‘Ozone Producing Equipment.’’ Those which do not produce ozone may be used in any area, provided shields are used to prevent exposure of workers to direct or reﬂected UV rays. Otherwise, rooms where unshielded UV lights are used should be equipped with switches at all entry points so the units may be turned off before workers enter. These switches should be identiﬁed with suitable placards such as ‘‘Ultraviolet Lights.’’ Employees should not enter areas where unshielded UV lights are burning because of possible damage to skin and eyes. K. Heat Exchangers Heat exchangers may be used to heat or cool product. Head exchangers may also be used to heat or cool gases or liquids which directly contact product. However, extreme caution should be exercised to prevent contamination. Inspectors and plant personnel should be alert to the following conditions and requirements: 1. Only heat exchangers media authorized by trade associations, FDA, USDA, and other standardization bodies in the United States, can be used for applications involving food product. Common materials such as brine or ammonia need not be submitted for review. Under no circumstances can toxic materials be used. 2. Heat exchangers should be routinely pressure tested to ensure that pinholes, hairline cracks, loose ﬁttings, or other similar defects are not present. Presence of off-color, off-odor, and/or off-ﬂavor may indicate leakage. Frequent depletion of heat exchange media may also indicate leakage. 3. Pressure on the product side should be higher than the media side. L.

In-Plant Trucks

Trucks used to transport product within the plant should be constructed of stainless steel. However, galvanized metal is acceptable provided it is maintained in a good state of repair and is regalvanized when necessary. Trucks should be free of cracks and rough seams. Metal wheels should be avoided as they cause deterioration of the ﬂoor surfaces. All trucks should have some means of afﬁxing a tag. This can be accomplished by drilling two holes approximately 1 in. (25.4 mm) apart in the lip of the truck to accommodate string or wire. M. Air Compressors Compressed air may be used to directly contact product and/or product contact surfaces provided the air is ﬁltered before entering a compressor and it is clean and free of moisture, oil, or other foreign material when contacting product or product contact surfaces. Lubricants and coolants directly contacting air should be authorized by trade associations, FDA, USDA, and other standardization bodies in the United States. © 2003 by Marcel Dekker, Inc.

Compressed air storage tanks should have a drain. Water and oil traps must be located between storage tanks and the point of use. Spent air must be exhausted in a manner to prevent product contamination. Air directly contacting product or product contact surfaces should be ﬁltered as near the air outlet as feasible. Filters should be readily removable for cleaning or replacement and should be capable of ﬁltering out 50-µm particles (measured in the longest dimension). Air intake on votators should also be ﬁltered. N.

Product Reconditioning Equipment

Product which is accidentally soiled may be cleaned on a separate, conveniently located wash table or sink. This wash station should be properly equipped with sprays and a removable, perforated plate to hold product off the bottom. The station should be identiﬁed as a ‘‘product wash station’’ and cannot be used for hand or implement washing. O.

Electric Cords

Accepting the use of electric cords should be based on both sanitary and safety considerations. Drop cords suspended from the ceiling may be retractable and used to connect portable equipment on an as needed basis if the cords are properly wired to the power source. Electric cords should not be strung across the ﬂoor even on a temporary basis. P.

Electric Insect Traps

Electric insect traps may be used in edible product handling and storage areas provided the following conditions are met: 1. 2. 3.

4. 5.

The equipment should be made of acceptable noncorrosive materials. The traps must not be placed above uncovered product or above uncovered product trafﬁcways. The electriﬁed components are either apparent or properly identiﬁed, insulated from nonelectriﬁed components, and covered with a protective grille to prevent electric shock hazard. The equipment should have a removable shelf or drawer which collects all trapped insects. The equipment is designed and constructed so that all dead insects are trapped in the removable shelf or drawer. (Insects must not collect on the protective grill.)

Removable drawers or shelves should be emptied as often as necessary. If the drawer or shelf becomes full of dead insects, then the fourth requirement above cannot be met so the equipment should be rejected for use. Dead insects must be removed from the unit before they create an odor problem. They cannot be left in the unit as bait. Q.

Inedible Product Equipment

Containers for handling and transporting inedible products should be watertight, maintained in a good state of repair (no rust or corrosion), and clearly marked with an appropriate identiﬁcation. All inedible product containers in the plant should be uniformly identiﬁed. Inedible product containers should be cleaned before being moved into an edible products department. © 2003 by Marcel Dekker, Inc.

Metal barrels, tanks, or trucks may be used for holding inedible poultry products in specially designated inedible product rooms. Alternatively, the containers may be stored outside the building provided the storage area is paved, drained, and conveniently located. These storage areas should also be equipped with nearby hose connections for cleanup. R. Blow-Off Equipment Using Compressed Air Filters used on the compressed air line should be readily removable for cleaning or replacement and should be capable of ﬁltering out 50µm particles. The air pressure must be measured and recorded with appropriate devices and must be set to deliver 75 to 125 psi (5.27 to 8.79 kg/cm2). The blow air must be conﬁned so that it is captured by a water curtain or by an exhaust system that has a suction of at least 1500 cfm (425 hectoliters/min) at the point of exhaust. S.

Ozone-Producing Equipment

Equipment which produces ozone may be used only in coolers designated for certain types of products, e.g., aging meat. The ozone concentration in the air must be measured and recorded with appropriate devices and cannot exceed 0.1 ppm. Ozone-generating equipment should be turned off and the ozone permitted to dissipate before any in-house or external inspection is performed. T.

Ozone Water Treatment and Recycling Equipment

Equipment used to ozonize and recycle water should be constructed from noncorrosive material with safe and easy access for cleanup and sanitary inspection of all component parts. Pumps and piping should be of acceptable sanitary type, demountable, and have quick-disconnect mechanisms at each change of direction. Tanks, funnels, ozone generators, ﬁlter housings, and ﬁlter media should have FDA/USDA acceptance and approval and they should be easily demountable for cleanup and sanitary inspection. A written approval of a water reuse procedure may be needed by state and federal regulators. There should also be written procedures for measuring and recording the total bacteria count and the total organic carbon level (TOC) in the ozone-treated water returning to the source of use. (Established guidelines: a total aerobic plate count of less than 1000/mL, coliform less than 10/mL, and E. coli less than 2/mL.) All systems should have monitoring devices on line 1. To measure and record the ozone level and concentration in the immediate area (ozone concentration cannot exceed 0.1 ppm) 2. To measure and record ozone level and range of turbidity in the water being returned to the source of use (all ozone must be dissipated at this time and turbidity must be within the range of 0.5–5.0 NTU (nephelometric turbidity units) 3. To automatically interrupt the water ﬂow if the quality of the ozone-treated water does not comply with established NTU guidelines. U. Sanitizing Solutions and Testing Devices A test kit or other device that accurately measures the concentration in milligrams per liter of sanitizing solutions should be provided. Testing devices to measure the concentration of sanitizing solutions are required for two reasons: © 2003 by Marcel Dekker, Inc.

1. 2.

The use of chemical sanitizers requires minimum concentrations of the sanitizer during the ﬁnal rinse step to assure sanitization. Too much sanitizer in the ﬁnal rinse water could be toxic.

VII. EQUIPMENT LOCATION AND INSTALLATION A.

Fixed Equipment Spacing or Sealing

A unit of equipment that is ﬁxed because it is not easily movable should be installed so that it is 1. 2. 3.

Spaced to allow access for cleaning along the sides, behind, and above the unit Spaced from adjoining equipment, walls, and ceilings a distance of not more than 1 mm or 1/32 in. Sealed to adjoining equipment or walls, if the unit is exposed to spillage or seepage

Table-mounted equipment that is not easily movable should be installed to allow cleaning of the equipment and areas underneath and around the equipment by being (1) sealed to the table or (2) elevated on legs as speciﬁed. When the weight of the equipment exceeds 14 kg (30 lb), it is no longer considered by the deﬁnition to be easily movable. Consequently, the following guide is noted: 1. 2. 3. 4. B.

Allow accessibility for cleaning on all sides, above, and underneath the units or minimize the need for cleaning due to closely abutted surfaces. Assure that equipment that is subject to moisture is sealed. Prevent the harborage of insects and rodents. Provide accessibility for the monitoring of pests.

Fixed Equipment Elevation or Sealing

Floor-mounted equipment that is not easily movable should be sealed to the ﬂoor or elevated on legs that provide at least 15-cm (6-in.) clearance between the ﬂoor and the equipment. However, if no part of the ﬂoor under the ﬂoor-mounted equipment is more than 15 cm (6 in.) from the point of cleaning access, the clearance space may be only 10 cm (4 in.). These suggestions do not apply to display shelving units, display refrigeration units, and display freezer units located in the consumer shopping areas of a retail food store, if the ﬂoor under the units is maintained clean. Table-mounted equipment that is not easily movable should be elevated on legs that provide at least 10-cm (4-in.) clearance between the table and the equipment. However, the clearance space between the table and table-mounted equipment may be (1) 7.5 cm (3 in.) if the horizontal distance of the table top under the equipment is no more than 50 cm (20 in.) from the point of access for cleaning or (2) 2.5 cm (2 in.) if the horizontal distance of the table top under the equipment is no more than 7.5 cm (3 in.) from the point of access for cleaning. C.

Summary

Stationary equipment or equipment not easily movable (i.e., no casters) should be installed far enough from walls and support columns to allow thorough cleaning and inspection. © 2003 by Marcel Dekker, Inc.

In addition, there must be ample clearance between the ﬂoor and the ceiling. If these clearances are not possible, then equipment should be sealed watertight to the surfaces. All wall-mounted cabinets, electric connections, and electronic components should be at least 1 in. from the wall or sealed watertight to the wall. The inability to adequately or effectively clean areas under equipment could create a situation that may attract insects and rodents and accumulate pathogenic microorganisms that are transmissible through food. The effectiveness of cleaning is directly affected by the ability to access all areas to clean ﬁxed equipment. It may be necessary to elevate the equipment. When elevating equipment is not feasible or is prohibitively expensive, sealing to prevent contamination is required. The economic impact of the requirement to elevate display units in retail food stores, coupled with the fact that the design, weight, and size of such units are not conducive to casters or legs, led to the exception for certain units located in consumer shopping areas, provided the ﬂoor under the units is kept clean. This exception for retail food store display equipment, including shelving, refrigeraion, and freezer units in the consumer shopping areas, requires a rigorous cleaning schedule. VIII. MAINTENANCE AND OPERATION A. Equipment Equipment should be in good repair and proper adjustment such that 1. Equipment should be maintained in a state of repair and condition that meets the requirements speciﬁed in this chapter. 2. Equipment components such as doors, seals, hinges, fasteners, and kick plates should be kept intact, tight, and adjusted in accordance with manufacturers’ speciﬁcations. 3. Cutting or piercing parts of can openers should be kept sharp to minimize the creation of metal fragments that can contaiminate food when the container is opened. Proper maintenance of equipment to manufacturer speciﬁcations helps assure that it will continue to operate as designed. Failure to properly maintain equipment could lead to violations of the associated requirements that place the health of the consumer at risk. For example, refrigeration units in disrepair may no longer be capable of properly cooling or holding potentially hazardous foods at safe temperatures. The cutting or piercing parts of can openers may accumulate metal fragments that could lead to food containing foreign objects and, possibly, result in consumer injury. Adequate cleaning and sanitization of dishes and utensils using a warewashing machine is directly dependent on the exposure time during the wash, rinse, and sanitizing cycles. Failure to meet manufacturer and stated requirements for cycle times could result in failure to clean and sanitize. For example, high temperature machines depend on the build-up of heat on the surface of dishes to accomplish sanitization. If the exposure time during any of the cycles is not met, the surface of the items may not reach the time– temperature parameter required for sanitization. Exposure time is also important in warewashing machines that use a chemical sanitizer since the sanitizer must contact the items long enough for sanitization to occur. In addition, a chemical sanitizer will not sanitize © 2003 by Marcel Dekker, Inc.

a dirty dish; therefore, the cycle times during the wash and rinse phases are critical to sanitization. B.

Cutting Surfaces

Cutting surfaces such as cutting boards and blocks that become scratched and scored may be difﬁcult to clean and sanitize. As a result, pathogenic microorganisms transmissible through food may accumulate. These microorganisms may be transferred to foods that are prepared on such surfaces. Surfaces such as cutting blocks and boards that are subject to scratching and scoring should be resurfaced if they can no longer be effectively cleaned and sanitized, or discarded if they are not capable of being resurfaced. IX. CLEANING OF EQUIPMENT AND UTENSILS A.

Objectives

Equipment food-contact surfaces and utensils should be clean to sight and touch. The food-contact surfaces of cooking equipment and pans should be kept free of encrusted grease deposits and other soil accumulations. Non–food-contact surfaces of equipment should be kept free of an accumulation of dust, dirt, food residue, and other debris. The objective of cleaning focuses on the need to remove organic matter from food-contact surfaces so that sanitization can occur and to remove soil from non–food-contact surfaces so that pathogenic microorganisms will not be allowed to accumulate and insects and rodents will not be attracted. B.

Frequency

Non–food-contact surfaces of equipment should be cleaned at a frequency necessary to preclude accumulation of soil residues. The presence of food debris or dirt on non–foodcontact surfaces may provide a suitable environment for the growth of microorganisms which employees may inadvertently transfer to food. If these areas are not kept clean, they may also provide harborage for roaches, ﬂies, mice, and other pests. C.

Methods

1. Dry Cleaning If used, dry cleaning methods such as brushing, scraping, and vacuuming should contact only surfaces that are soiled with dry food residues that are not potentially hazardous. Cleaning equipment used in dry cleaning food-contact surfaces may not be used for any other purpose. Dry cleaning methods are indicated in only a few operations, which are limited to dry foods that are not potentially hazardous. Under some circumstances, attempts at wet cleaning may create microbiological concerns. a. Precleaning. Food debris on equipment and utensils should be scrapped over a waste disposal unit, scupper, or gargbage receptacle or should be removed in a warewashing machine with a prewash cycle. If necessary for effective cleaning, utensils and equipment should be preﬂushed, scrubbed with abrasives, or presoaked. © 2003 by Marcel Dekker, Inc.

Precleaning of utensils, dishes, and food equipment allows for the removal of grease and food debris to facilitate the cleaning action of the detergent. Depending upon the condition of the surface to be cleaned, detergent alone may not be sufﬁcient to loosen soil for cleaning. Heavily soiled surfaces may need to be presoaked or scrubbed with an abrasive. 2. Wet Cleaning Equipment, food-contact surfaces, and utensils should be effectively washed to remove or completely loosen soils by using the manual or mechanical means necessary, such as the application of detergents containing wetting agents and emulsiﬁers; acid, alkaline, or abrasive cleaners; hot water; brushes; scouring pads; or high-pressure sprays. The washing procedures selected should be based on the type and purpose of the equipment or utensil, and on the type of soil to be removed. Because of the variety of cleaning agents available and the many different types of soil to be removed, it is not possible to recommend one cleaning agent to ﬁt all situations. Each of the different types of cleaners works best under different conditions (e.g., some work best on grease; some work best in warm water; others work best in hot water). The speciﬁc chemical selected should be compatible with any other chemicals to be used in the operation such as a sanitizer or drying agent. X.

SANITIZATION OF EQUIPMENT AND UTENSILS

A. Objective Equipment food-contact surfaces and utensils should be sanitized. Effective sanitization procedures destroy organisms of public health importance that may be present on wiping cloths, food equipment, or utensils after cleaning, or which have been introduced into the rinse solution. It is important that surfaces be clean before being sanitized to allow the sanitizer to achieve its maximum beneﬁt. B. Frequency Utensils and food-contact surfaces of equipment should be sanitized before use and after cleaning. Sanitization is accomplished after the warewashing steps of cleaning and rinsing so that utensils and food-contact surfaces are sanitized before coming in contact with food and before use. C. Methods After being cleaned, equipment, food-contact surfaces, and utensils should be sanitized by hot water manual operations by immersion for at least 30 sec as speciﬁed in standard manuals or hot water mechanical operations by being cycled through equipment that is set up as speciﬁed elsewhere achieving a utensil surface temperature of 71°C (160°F) as measured by an irreversible registering temperature indicator or through the use of chemical means. Chemical manual or mechanical operations, including the application of sanitizing chemicals by immersion, manual swabbing, brushing, or pressure-spraying methods, using a solution as speciﬁed in a standard manual, FDA/USDA regulations, or trade recommendations includes (1) an exposure time of at least 10 sec for chlorine solution, (2) an expo© 2003 by Marcel Dekker, Inc.

sure time of at least 30 sec for other chemical sanitizer solutions, or (3) an exposure time used in relationship with a combination of temperature, concentration, and pH that, when evaluated for efﬁcacy, yields sanitization as deﬁned elsewhere. Efﬁcacious santization is dependent upon warewashing being conducted within certain parameters. Time is a parameter applicable to both chemical and hot water sanitization. The time that hot water or chemicals contact utensils or food-contact surfaces must be sufﬁcient to destroy pathogens that may remain on surfaces after cleaning. Other parameters, such as temperature or chemical concentration, are used in combination with time to deliver effective sanitization.

XI. PROTECTION OF CLEAN ITEMS A.

Drying

For equipment and utensils, air drying requirements include 1. 2. 3. 4.

B.

After cleaning and sanitizing, equipment and utensils may not be cloth dried. Equipment and utensils may be air dried or used after adequate draining as speciﬁed in FDA regulations (21 CFR 178.1010) before contact with food. Utensils that have been air dried may be polished with cloths that are maintained clean and dry. Items must be allowed to drain and to air dry before being stacked or stored. Stacking wet items such as pans prevents them from drying and may allow an environment where microorganisms can begin to grow. Cloth drying of equipment and utensils is prohibited to prevent the possible transfer of microoriganisms to equipment or utensils.

Lubricating and Reassembling

Lubricants should be applied to food-contact surfaces that require lubrication in a manner so that food-contact surfaces are not contaminated. Equipment should be reassembled so that food contact surfaces are not contaminated. C.

Storing

Cleaned equipment and utensils should be stored (1) in a clean, dry location, (2) where they are not exposed to splash, dust, or other contamination, and (3) at least 15 cm (6 in.) above the ﬂoor. Further, equipment and utensils should be stored (1) in a selfdraining position and (2) covered or inverted. Clean equipment and multi-use utensils which have been cleaned and sanitized can become contaminated before their intended use in a variety of ways, such as through water leakage, pest infection, or other insanitary conditions. Cleaned and sanitized equipment and utensils may not be stored In locker rooms In toilet rooms In mechanical rooms Under sewer lines that are not shielded to intercept potential drips © 2003 by Marcel Dekker, Inc.

Under leaking water lines including leaking automatic ﬁre sprinkler heads or under lines on which water has condensed Under open stairwells Under ther sources of contamination The improper storage of clean and sanitized equipment, and utensils may allow contamination before their intended use. Contamination can be caused by moisture from adsorption, ﬂooding, drippage, or splash. It can also be caused by food debris, toxic materials, litter, dust, and other materials. The contamination is often related to unhygienic employee practices, unacceptable high-risk storage locations, or improper construction of storage facilities. XII. CONCLUSION For any food processor, the sanitation of equipment is a permanent problem. Contamination of food or food ingredients by unclean equipment has been the cause of foodborne diseases in human population throughout the history of modern civilization. It is important that a food processor comply with good manufacturing practices to reduce the potential of equipment being the source of human pathogens or poisonous chemicals. ACKNOWLEDGMENT Most data provided in this chapter have beem modiﬁed with permission from documents prepared by Science Technology System, West Sacramento, CA.

© 2003 by Marcel Dekker, Inc.

14 Workers’ Personal Hygiene TIN SHING CHAO U.S. Department of Labor, Honolulu, Hawaii, U.S.A.

I.

INTRODUCTION

Because the food processing industry is labor intensive, that is, reliant on large numbers of employees, personnel is a key resource to a company. It is management’s responsibility to hire hygiene-conscious employees. The economic effect of a foodborne disease outbreak can be devastating to a food processing plant. The public has a right to expect safe, sanitary, and wholesome food from any food producing company. II. FOOD POISONING Reports of foodborne and waterborne diseases are periodically published in the United States. The number of outbreaks reported are thought to be fewer than the actual number of outbreaks. Since many of the symptoms resemble symptoms of the 24-hour ﬂu, the actual outbreaks occurring in the United States are probably far greater than the number being reported. Several key events are necessary for a foodborne disease outbreak. You may remember the story of Typhoid Mary, a real-life case that cost many people’s lives as a result of poor personal hygiene practices. The practice of clean habits in a food processing area is the only way to achieve a satisfactory standard of hygiene. III. A BRIEF OVERVIEW OF BACTERIA Bacteria are small, single-celled organisms which can only be seen under a microscope. They are everywhere in our surroundings, and as most bacteria cannot live by themselves they have to be transferred to something by coming into direct contact with it. Some bacteria form spores. These spores can withstand high temperatures for long periods of © 2003 by Marcel Dekker, Inc.

time, and on return to favorable conditions they become normal bacteria again, which then multiply. Some bacteria secrete exogenous toxins outside their bodies. These toxins, when mixed with food, render the food itself poisonous, and symptoms of food poisoning follow within a few hours. Other bacteria cause food poisoning by virtue of large numbers bacteria in food entering the digestive system, multiplying further, and setting up an infection. Certain bacteria produce heat-resistant toxins. Foods in which this toxin have been produced may still cause illness even when the food is heated to boiling and boiled for half an hour. Some bacteria will grow in the absence of air (anaerobes); others need it (aerobes). Bacteria multiply by dividing in two, under favorable conditions, about once every 20 min. Therefore, one bacterium could multiply in 10–12 hr to between 500 million and 1000 million bacteria. Not all bacteria are harmful. Some are useful (e.g., those used in cheese production and wine making). Some cause food spoilage (e.g., souring of milk). Some bacteria that are conveyed by food cause disease other than food poisoning. These include typhoid, paratyphoid, dysentery, and scarlet fever. In these cases the bacteria do not multiply in the food; they are only carried by it, and the disease is known as a foodborne disease. With bacterial food poisoning the bacteria multiply in the food. Time between eating the contaminated food (ingesting) to the beginning of the symptoms of the illness (onset) depends on the types of bacteria causing the illness. Table 1 on pages 214–215 provides selected information on foodborne illnesses. It is excerpted from the work of Mr. Lance Wong, the education ofﬁcer for the State of Hawaii Food Safety Consultation and Education Program. He used the National Restaurant Association Educational Foundation’s HACCP Reference Book (1993) and Control of Communicable Disease in Men (1990), edited by Abram S. Beneson. The intent of this table is to aid food plant workers to learn about different causative agents, their incubation periods, their symptoms, and the food they could be harbored in to improve awareness of the most common foodborne diseases. Certain favorable conditions must be met in order for bacteria to multiply. These are food of the right kind, at suitable temperature, with adequate moisture, and over sufﬁcient elapsed time. Food-poisoning bacteria live in the soil; in human intestines, nose, throat, skin, cuts, sores, spots, etc.; and in animals, insects, and birds. IV. SPREAD OF INFECTION Foodborne pathogenic bacteria can be spread by (1) food handlers’ coughing and sneezing and via their hands; (2) animal, insect, and bird droppings, hair, etc.; and (3) inanimate objects such as towels, dish cloths, knives, boards, and any other tools used in food processing. V.

PREVENTION OF FOOD POISONING FROM BACTERIA

There are several ways we can prevent food poisoning from bacteria. One way to prevent bacteria from spreading from place to place is sound hygiene practice. If bacteria has already spread to the food, it is still possible to prevent food poisoning by controlling bacteria from multiplying to a level that could cause a human to get sick. Temperature is a factor to control the growth rate of the bacteria. Safe temperature for cold food shall be 45°F (7.2°C) or below, and safe temperature for hot food shall be 140°F (60°C) or above. Unfortunately, food intoxication or food poisoning is not affected by temperature. © 2003 by Marcel Dekker, Inc.

Once the toxicant produced by the bacteria had been ingested, people will get sick. The only way to prevent it is to discard the food item and not consume or taste it. VI. PERSON-TO-PERSON CONTAMINATION Humans play a very important part in spreading the infecting bacteria. We can also be the ones to break the chain of contamination. Once the chain is broken we can prevent bacteria from spreading from place to place and from multiplying. Most of the time, because food is mishandled by people, the chain of contamination continues until someone gets sick or dies before actions are taken to prevent further outbreaks. Prior to the discussion of personal hygiene, it is important for one to understand how people and the environment can easily contaminate food. This discussion is based on the assumption of a real world situation and will be limited to demonstrate how easily a food item could be contaminated before and after reaching a food processing plant. The author believes if every person who handles food could achieve personal hygiene to its highest standards, food contamination could be kept to a minimum. Every single person throughout the chain can play a very important part in preventing food being contaminated. Take, for example, a chicken farmer who supplies the birds to a food processing plant. We assume the chicken farmer has not been to a food handler safety class and all he cares about is his proﬁts. The food processing plant purchased the birds from this chicken farmer because he offered the best price among its competitors. This chicken farm occupied several acres of land since its opening. Maintenance of the premises was minimal and they have only cleaned their farm once in the past ten years. The environment is a source of contamination. One of the workers who worked at the chicken farm had a cold and had diarrhea, but he continued to work at the farm. This person is a source of contamination. The refrigerated truck used to hold the chicken had held raw beef and raw pork, but it was not cleaned before different products were stored. This is a possible source of cross-contamination. The driver had delivered some raw chickens to a food processing plant, and at their receiving areas the receiving clerk did not check the temperature of the delivery and it was 25°F (14°C) above the safe temperature. This was a temperature abuse that would possibly lead to a foodborne outbreak. The receiving temperature was 70°F (21.1°C). Since that day was a national holiday, the processing plant was short-staffed, and the receiving clerk was called by a supervisor from another department to help. The birds he just received were left on the transporting cart at room temperature. We assumed that the birds produced in that chicken farm are contaminated with salmonella. The day was hot and the temperature inside the processing plant was about 80°F (26.7°C). Salmonella on the chicken was multiplying in a log phase. This is temperature abuse again. Bacteria multiply when a favorable condition exists. When the clerk came back in a few hours he then realized that the chickens were still left out at the receiving area. He then quickly pushes the cart into the holding refrigerator. The temperature of the holding refrigerator is in the danger zone since it was opened many times during the day. The next day when people came back from the national holiday they were all tired and lazy. After they used the toilet they did not wash their hands before returning to work. The food was likely to be further contaminated by the workers. Chickens were processed but somehow the cooking temperature did not reach an internal temperature of 160°F (71.1°C) or above. No one checked the ﬁnal cooking temperature. The chicken was separated and packed into individual packages and shipped to the supermarket. Consumers who purchased these chicken products are likely to have a food poisoning event. © 2003 by Marcel Dekker, Inc.

Table 1

Foodborne Illness Information Table

Disease

Causative agent

Incubation period

Symptoms

Salmonellosis

Salmonella

6–48 hr (usually 12–24 hr)

Fever, headache, abdominal pain, diarrhea, nausea, sometimes vomiting

Shigellosis

Shigella

1–7 days

Diarrhea (often bloody with mucus), fever, chills, nausea, abdominal pain

Listeriosis

Listeria monocytogenes

4–21 days

Fever, headache, nausea, vomiting, chills, backache, meningitis, stillbirths

Campylobateriosis

Campylobacter jejuni

1–10 days (usually 3–5 days)

Vibrio parahaemolyticus gastroenteritis

Vibrio parahaemolyticus

4–96 hr (usually 12–24 hr)

Diarrhea (often bloody with mucus), fever, nausea, abdominal pain, vomiting Watery diarrhea, abdominal cramps, nausea, vomiting, fever, headache

Norwalk virus gastroenteritis

Norwalk and Norwalk-like viral agent

24–48 hr

© 2003 by Marcel Dekker, Inc.

Nausea, vomiting, diarrhea, abdominal pain, headache, low grade fever

Food implicated Poultry, poultry salads, pork, meat and meat products, milk, shell eggs, egg custards and sauces, other protein foods Potato, tuna, shrimp, turkey, macaroni and fruit salads, lettuce, moist and mixed foods Unpasteurized milk and cheese, seafood, vegetables, poultry and meats, and prepared chilled ready-to-eat foods Unpasteurized milk and dairy products, poultry, pork, beef, lamb Raw or inadequately cooked seafood or any food crosscontaminated by handling raw seafood Raw shellﬁsh, raw vegetables, salads, prepared salads, water contaminated from human feces

Infectious hepatitis

Hepatitis A virus

15–20 days (average 28– 30 days)

Fever, malaise, anorexia, nausea, abdominal discomfort, jaundice

Clostridium perfringens enteritis

Clostridium perfringens toxin

8–24 hr (usually 24 hr)

Abdominal pain, diarrhea, nausea

Pathogenic E. coli diarrhea or hemorrhagic colitis

Pathogenic strains of E. coli (e.g., 0157:H7)

12–72 hr

Bacillus cereus gastroenteritis

Bacillus cereus toxin

1–6 hr (vomiting) 6–24 hr (diarrhea)

Diarrhea (often bloody), severe abdominal pain, vomiting, kidney complications Nausea, vomiting, abdominal cramps, diarrhea

Staphylococcal intoxication

Staphylococcus aureus toxin

1–6 hr (usually 2–4 hr)

Vomiting, nausea, diarrhea, dehydration

Botulism

Clostridium botulinum toxin

12–36 hr

Ciguatera ﬁsh poisoning

Ciguatoxin

2–24 hr (usually 3–5 hr)

Scombroid ﬁsh poisoning

Histamine and related compounds

Few minutes to several hours

Nausea, diarrhea, vomiting, cramps, headache, vertigo, paralysis, death Weakness, muscle and joint pain, diarrhea, chills, numbness, nausea, temperature reversal, vomiting Flushed face, headache, rapid heart rate, cramps, diarrhea, itching, breathing trouble

© 2003 by Marcel Dekker, Inc.

Contaminated water, food contaminated by infected food handlers, including sandwiches and salads, raw or undercooked mollusks Improperly cooled or inadequately reheated foods (meats, stews, sauce, gravies, soups) Raw and uncooked ground beef and other red meats, raw milk Cooked rice, potatoes, pasta, green beans, vegetable sprouts, dry spices Ham and other meats, dairy products, custards, salads (potato), cream-ﬁlled desserts Low-acid canned or vacuumpacked foods, smoked meats, condiments Numerous varieties of tropical/reef ﬁsh (e.g., barracuda, ulua, kahala, kole, po’ou) Mainly mahi mahi, ahi, aku, akule, opelu, au, ulua

It is important for everyone who participates in the process to be aware of the safe handling of food and to practice good personal hygiene. Contaminated chicken went from the chicken farmer to the processing plant, from the processing plant to the supermarket, and from the market to the consumer. The contamination chain could be broken at any point through the practice of sound hygiene measures to prevent foodborne outbreaks. Remember, the consumer counts on food processors to produce safe and healthy food. And as a food-processing worker you should be proud that you are being part of this process in producing clean and wholesome food. VII. PERSONAL CLEANLINESS A person wants to live a happy life. In order to achieve this goal, it is necessary for a person to set their state of mind to live a happy life. One has to perform certain activities to make one’s life a happy one, and through the joy of achievement they would become a happy person. Achieving personal cleanliness works on the same principle. An ordinary person would want to stay clean and healthy. In a food processing plant, higher standards should be set. Self-respect is also necessary in every food processing plant because pride in one’s appearance promotes a high standard of cleanliness and physical ﬁtness. Persons with ill health or who are not clean about themselves should not handle food. There are certain activities that will help a person to achieve this goal of personal hygiene. A.

Bathing

Regular bathing at least once a day is essential; otherwise germs can be transferred onto the clothes and so onto food. There are germs living on our body. Some of these germs are beneﬁcial to us, but some of the pathogenic germs are bad. If foods are being contaminated, people who consume the food will become sick and might even die from consuming such contaminated foods. Therefore, it is important for a person to bathe or shower daily to stay clean. B.

Hands

Hands must be thoroughly washed frequently, particularly after using the bathroom, before commencing work, and whenever food is to be handled. They should be washed in hot water with the aid of brush and soap; rinsed; and dried on a clean towel, suitable paper towel, or by a hand hot-air drier. Hands and ﬁngernails if not kept clean can be a great source of danger as they can so easily transfer harmful bacteria onto food. Many people think when they are using antibacterial hand soap, the germs or bacteria will be automatically washed off. This may be true, but in order for the antibacterial hand soap to work properly, follow the directions on the bottle. It will tell you, for example, how long you have to leave the soap on, and you have to continue rubbing both of your hands continuously for a certain amount of time in order for certain hand soap to effectively remove bacteria. The author has attended many food handler classes, and one instructor had said the proper way of washing one’s hands is to continue to rub both of your hands with hand soap, especially the ﬁnger tips, for at least 30 seconds. Try it yourself with a timer for 30 seconds and compare it to how much time you have used to wash your hands in the past. You will discover how long to wash and scrub your hands. Many food processing plants are now providing hand gloves to their employees. For many of the workers, if not properly trained, this might give them a false sense of © 2003 by Marcel Dekker, Inc.

security. They may have a misconception that if gloves were used, food would not be contaminated. Sometimes, they can forget to change their gloves after touching their nose, scratching their heads, or even picking up something dropped on the ﬂoor with the gloves on. Therefore, workers who use hand gloves should be aware of this point. Rings, watches, and jewelry should not be worn when food is handled. Particles of food may be caught under a ring, and germs could multiply until they are transferred into food. Watches (apart from the fact that steam ruins them) should not be worn when handling food. For example, in a salad and cabbage processing plant, foodstuffs have to be plunged into plenty of water; they may not be properly washed because a watch is worn. Jewelry should not be worn in a food processing plant, since it may fall off into food, unknown to the wearer. C. Fingernails Fingernails should always be kept clean and short as dirt can easily lodge under the nail and be discharged when, for example, handling and processing food, thereby introducing bacteria into food. Fingernails should be cleaned with a nailbrush, and nail varnish should not be worn when one has to process food at a food processing plant. D. Hair Hair should be washed regularly and kept covered when food is being handled. Hair that is not cared for is likely to come out or shed dandruff, which may fall into food, becoming an unwanted food additive. Men’s hair should be kept short as it is easier to keep clean; it also looks neater. Women’s hair should be covered as much as possible. The hair should never be scratched, combed, or touched while handling or processing food because germs and bacteria could be transferred via the hands to the food. E.

Nose

The nose should not be touched when food is being handled. If a handkerchief is used, the hands should be washed afterward. Ideally, a paper handkerchief should be used and then discarded, the hands being washed afterward. The nose is an area harboring vast numbers of harmful bacteria; it is therefore very important that neither food, people, nor working surfaces are sneezed over, thus, spreading germs and bacteria. F.

Mouth

There are germs and bacteria in the areas of the mouth; therefore, the mouth or lips should not be touched by hands or utensils which may come into contact with food. No cooking utensils should be used for tasting food, nor should ﬁngers be used for this purpose as germs and bacteria may be transferred to food. A clean teaspoon should be used for tasting and washed well afterward. Coughing over food and working areas should be avoided as germs and bacteria are spread long distances if not trapped in a handkerchief. G.

Ears

The ear holes should not be handled in food processing areas as, again, germs and bacteria can be transferred into food by touching the ear and then food. © 2003 by Marcel Dekker, Inc.

H.

Teeth

Sound teeth are essential to good health. They should be kept clean and visits to the dentist should be regular so that teeth can be kept in good repair. One should brush one’s teeth daily at least two times and ﬂoss after every meal. I.

Feet

As food handlers stand for many hours, care of the feet is important. They should be washed regularly, and the toenails kept short and clean. Tired feet can cause general tiredness, which leads to carelessness, and this often results in a lowering of the standards of hygiene. J. Cuts, Burns, Sores, Etc. It is particularly important to keep all cuts, burns, scratches, and similar openings of the skin covered with a waterproof dressing. Where the skin is septic, as with certain cuts, spots, sores, and carbuncles, there are vast numbers of harmful bacteria which must not be permitted to get on food. In most cases people suffering in this way should not handle food in order to prevent harmful germs being accidentally transferred to food. K.

Cosmetics

Cosmetics, if used by food handlers, should be used in moderation. They should not be applied in the food processing area and hands should be washed well afterward. Cosmetics should be put on clean skin and not used to cover up dirt. L.

Smoking

Smoking must never take place where there is food being processed. When a cigarette is taken from the mouth, germs and bacteria from the mouth can be transferred to the ﬁngers and so onto food. When a cigarette is put down, the end which has been in the mouth can transfer germs to the working surface. Ash on food is most objectionable and it should be remembered that smoking where there is food handling is against the law. M. Spitting Spitting should never occur, because germs and bacteria can be spread by this objectionable habit. There are times when you need to spit out things. Do it in the bathroom and spit directly into the toilet bowl and ﬂush it after spitting. Don’t forget to wash your mouth and your hands before returning to work. N.

Clothing and Cloths

Clean white protective clothing and clean underclothes should be worn at all times. Dirty clothes enable germs and bacteria to multiply, and if dirty clothing comes into contact with food the food may be contaminated. Cloths used for wiping clean utensils or used for holding hot cooking utensils or used to wipe working surfaces in case of spills should also be kept clean and stored in the sanitizing solutions when not in use. Be sure to change the sanitizing solutions at regular intervals because the organic materials accumulating will compromise the strength of the sanitizing solution. Outdoor clothing and other cloth© 2003 by Marcel Dekker, Inc.

ing taken off before wearing white working clothes should be kept in a locker away from the food processing area. VIII. GENERAL HEALTH AND FITNESS The maintenance of good health is essential to prevent the introduction of germs and bacteria into the food processing areas. To keep physically ﬁt, adequate rest, exercise, fresh air, and wholesome diet are essential. Persons employed in a food processing kitchen require adequate sleep and relaxation, as they are on the move all the time, often in a hot atmosphere where the tempo of work may be very fast. Frequently, the hours are long or extended over a long period of time, as with split duty, or they may extend into the night. In off-duty periods it may be wise to get some rest rather than spend all the time energetically. The amount of sleep and rest required depends on each person’s needs, and the variation between one person and the next is considerable. People working in conditions of nervous tension, extreme heat, and odd hours need a change of environment and, particularly, fresh air. Swimming, walking, or cycling in the countryside may be suitable ways of obtaining both exercise and fresh air. A well-balanced diet, correctly cooked, and pure water will assist in keeping a person ﬁt. The habit of ‘‘picking’’ (eating small pieces of food while working) is bad; it spoils the appetite and does not allow the stomach to rest. This bad habit may transfer germs and bacteria from your mouth to your hands into food, contaminating the food being handled. Meals should be taken regularly; long periods of work without food are also bad for the stomach. Hungry workers might lose their concentration; accidents may happen if a person is tired and has not enough energy to carry on with work. Pure water is ideal for replacing liquids lost by perspiring in a hot working area. A soft drink may be used to replace some of the salt as well as ﬂuid lost in sweating. IX. EMPLOYEE TRAINING The importance of training employees to meet company standards, industry standards, regulatory standards, and consumer expectations cannot be overemphasized; this is one of the key elements to help a company survive and be competitive. The traditional ways of training employees such as in a classroom setting, using textbooks, and showing videos may still be a viable way to train a company’s employees. But in recent years a new concept has been developed. It is behavior-based training. The author believes that if a company focuses on behavior, rather than the individual, one can change the organization. A lot of the companies lack the education, training, and experience to change people’s behavior, believing that changing people should be left to psychiatrists and clinical psychologists. This concept is wrong. Focusing on observable behavior and learning from mistakes could help renew a company. Instead of trying to change attitudes, perceptions, and cognition (because they are too difﬁcult to deﬁne), we suggest focusing on system factors that indirectly change attitudes, commitment, and motivation, such as management systems, policies, and supervisory behavior. Direct with activators, and motivate with consequences. Activators are signals that precede our behavior and tell us what to do to receive a consequence; however, we behave only in ways that result in a desired consequence, or the avoidance of an undesired consequence. Focus on positive consequences to improve behavior. For example: a worker in a food processing plant uses © 2003 by Marcel Dekker, Inc.

a machine to cut chickens in half, but if operated carelessly there is a risk of losing a hand (negative consequence). The signiﬁcance of this negative consequence is the risk of losing a hand; the probability of negative events as a result of risky behavior is usually very low because no one would want a hand to be cut off. If there were a one-to-one correlation of losing your hand when a certain behavior took place, the behavior usually wouldn’t occur. Finally, if good positive personal hygiene behaviors are repeatedly rewarded, sooner or later they will become good habits, which can be part of the organizational behavior and can also inﬂuence other workers in the same plant. X.

CONTINUOUS EVALUATION

In order to ensure a personal hygiene training program works for your organization, it is important for management to have a continued evaluation program to ensure effective hygiene practices are incorporated in an organization. A periodic inspection is a useful tool to determine its effectiveness. Supervisors should always lead by example. Supervisors should also observe how employees perform their hygiene practices to identify if there is a need to retrain employees. Statistics show that most people forget what they learn after a period of time. It is suggested to have an annual or biannual retraining if the company can afford the time to retrain their employees. XI. CONCLUSION Bacteria are present all around us. Some of them are beneﬁcial, but some are not. It is important for individuals who work in a food processing plant to break the chain of contamination by following sound hygiene practices. Everyone is important in keeping the food safe from farm to table. It is true that the government has set rules and regulations for different food processing plants to follow, but these rules and regulations will not be effective unless enforced and followed by the workers. Remember that consumers are counting on food processors to safeguard this process. Let us work together with our employers and our government to ensure that products are produced in our processing plants under sound hygienic conditions.

© 2003 by Marcel Dekker, Inc.

15 Worker Safety and Regulatory Requirements TIN SHING CHAO U.S. Department of Labor, Honolulu, Hawaii, U.S.A.

I.

INTRODUCTION

More than 90 million Americans spend their days at a job. They are the most important assets of this country. Yet before 1970 there were no uniform and comprehensive provisions for their safety and protection against workplace hazards. On December 29, 1970, the Senate and House of Representatives of the 91st Congress enacted Public Law 91596. It is also known as the Williams–Steiger Act, and is also cited as the Occupational Safety and Health Act of 1970 (the Act). The Act was later amended by Public Law 101552, Section 3101, November 5, 1990.

II. CONGRESSIONAL FINDINGS AND PURPOSE The U.S. Congress found that personal injuries and illnesses arising out of work situations impose a substantial burden upon and are a hindrance to interstate commerce in terms of lost production, wage loss, medical expenses, and disability compensation payments. The congress declared that its purpose and policy is to assure, so far as possible, every working man and woman in the nation safe and healthful working conditions, to preserve our human resources, and to provide for the general welfare of all working people. This is enacted through regulation of commerce among the several states and with foreign nations in several areas [1]: 1. By encouraging employers and employees in their efforts to reduce the number of occupational safety and health hazards at their places of employment and © 2003 by Marcel Dekker, Inc.

2.

3.

4. 5.

6.

7.

8. 9. 10.

11.

12.

to stimulate employers and employees to institute new, and to perfect existing, programs for providing safe and healthful working conditions By providing that employers and employees have separate and independent responsibilities and rights with respect to achieving safe and healthful working conditions By authorizing the Secretary of Labor to set mandatory occupational safety and health standards applicable to businesses affecting interstate commerce and by creating an Occupational Safety and Health Review Commission for carrying out adjudicatory function under the Act By building upon advances already made through employer and employee initiatives for providing safe and healthful working conditions By providing for research in the ﬁeld of occupational safety and health, including the psychological factors involved and by developing innovative methods, techniques, and approaches for dealing with occupational safety and health problems By exploring ways to discover latent diseases, establishing causal connections between diseases and work in environmental conditions, and conducting other research relating to health problems often different from those involved in occupational safety By providing medical criteria which will assure insofar as practicable that no employee will suffer diminished health, functional capacity, or life expectancy as a result of work experience By providing for training programs to increase the number and competence of personnel engaged in the ﬁeld of occupational safety and health By providing for the development and promulgation of occupational safety and health standards By providing an effective enforcement program which shall include a prohibition against giving advance notice of any inspection and sanctions for any individual violating this prohibition By encouraging the states to assume the fullest responsibility for the administration and enforcement of their occupational safety and health laws by providing grants to the states to assist in identifying their needs and responsibilities in the area of occupational safety and health, to develop plans in accordance with the provision of this Act, to improve the administration and enforcement of state occupational safety and health laws, and to conduct experimental and demonstration projects in connection therewith By encouraging joint labor management efforts to reduce injuries and disease arising out of employment

III. THE ACT The purpose of the Act is to assure safe and healthful working conditions for working men and women. It is enacted by authorizing enforcement of the standards developed under the Act, by assisting and encouraging the states in their efforts to assure safe and healthful working conditions, and by providing for research, information, education, and training in the ﬁeld of occupational safety and health [1]. © 2003 by Marcel Dekker, Inc.

A. Coverage The Act extends to all employers and employees in all ﬁfty states, the District of Columbia, Puerto Rico, and all other territories under the federal government jurisdiction. Coverage is provided either by the Federal Occupational Safety and Health Administration (OSHA) or approved state programs. The Occupational Safety and Health Act of 1970 encourages states to develop and operate their own job safety and health plans. States with approved plans under section 18(b) of the Occupational Safety and Health Act must adopt standards and enforce requirements that are as effective as federal requirements. There are currently 25 state plan states; 23 of these states administer plans covering both private and public (state and local government) employees, the other two states—Connecticut and New York—cover public employees only. Plan states must adopt standards comparable to federal requirements within 6 months of a federal standard’s promulgation. Until such time as a state standard is promulgated, Federal OSHA provides interim enforcement assistance, as appropriate, in the states. Criteria for state plans are listed under 29 CFR 1902, State Plans for the Development and Enforcement of State Standards [1]. An employer is any person engaged in a business affecting commerce who has employees, but this does not included the United States or any state or political subdivision of a state. The following are not covered under the act: (1) self-employed persons; (2) farms at which only immediate members of the farm employer’s family are employed; and (3) working conditions regulated by other federal agencies under other federal statutes.

IV. OCCUPATIONAL SAFETY AND HEALTH LAW The Code of Federal Regulations is a codiﬁcation of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government. The Code is divided into 50 titles, which represent broad areas subject to federal regulation. Each title is divided into subchapters covering speciﬁc regulatory areas. Title 29 refers to labor laws. It is composed of nine volumes. The Occupational Safety and Health Laws are recorded under 29 CFR Parts 1900–1910.999, Parts 1910.1000 to end, Parts 1911–1925, Part 1926, and Parts 1927 to end [2].

V.

OSHA INSPECTION

Under the Occupational Safety and Health Act of 1970 Act, the Occupational Safety and Health Administration is authorized under the Act to conduct workplace inspections to determine whether employers are complying with the OSHA standards issued by the agency for safe and healthful workplaces. The Occupational Safety and Health Administration also enforces Section 5(a)(1) of the Act, also known as the General Duty Clause, which requires that every working man and woman be provided with a safe and healthful workplace. Workplace safety and health inspections are performed by OSHA compliance safety and health ofﬁcers who are knowledgeable and experienced in the occupational safety and health ﬁeld and who are trained in OSHA standards and in the recognition of safety and health hazards. Similarly, states with their own occupational safety and health programs must conduct inspections using qualiﬁed state compliance safety and health ofﬁcers. © 2003 by Marcel Dekker, Inc.

Inspections are usually conducted without advance notice. In fact, alerting an employer without proper authorization in advance of an OSHA inspection can bring a ﬁne up to $1,000 and/or a 6-month jail term. This is true for Federal OSHA compliance ofﬁcers as well as state inspectors. There are, however, special circumstances under which OSHA may give advance notice to the employer, but such a notice will normally be less than 24 hours. If an employer refuses to admit an OSHA compliance ofﬁcer or if an employer attempts to interfere with the inspection, the Act permits appropriate legal action, such as obtaining a warrant to inspect [3].

A.

Inspection Priorities

Not all 6.2 million workplaces covered by the Act can be inspected immediately. The worst situations need attention ﬁrst. Therefore, OSHA has established a system of inspection priorities. Imminently dangerous situations are given top priority. An imminent danger is any condition where there is reasonable certainty that a danger exists that can be expected to cause death or serious physical harm immediately or before the danger can be eliminated through normal enforcement procedures. Second priority is given to investigation of fatalities and accidents resulting in hospitalization of three or more employees. Such catastrophes must be reported to OSHA by the employer within 8 hr. The OSHA inspectors will investigate and determine the cause of such accidents and whether existing OSHA standards were violated. Third priority is given to formal employee complaints of alleged violations or standards, or of unsafe or unhealthful working conditions, and to referrals from other government authorities about speciﬁc workplace hazards. The Act gives each employee the right to request an OSHA inspection when the employee believes he or she is in imminent danger from a hazard or when he or she thinks that there is a violation of an OSHA standard that posts physical harm. The Occupational Safety and Health Administration will maintain conﬁdentiality if requested, and will inform employees of any action it takes regarding the complaint. Next in priority are programmed inspections aimed at speciﬁed high-hazard industries, workplaces, occupations, or health substances, or other industries in OSHA’s current inspection procedures. Industries are selected for inspection on the basis of factors such as injury incident rates, previous citation history, employee exposure to toxic substances, or random selection. Special emphasis programs also may be developed and may be regional or national in scope, depending on the distribution of the workplaces involved. Comprehensive safety inspections in manufacturing will be conducted normally in those establishments with lost-workday injury rates at or above the Bureau of Labor Statistics (BLS) national rate for manufacturing currently in use by OSHA. States with their own occupational safety and health programs may use somewhat different systems to identify industries for inspection. An establishment can expect a follow-up inspection if an OSHA violation has been issued to the establishment. A follow-up inspection determines if previously cited violations have been corrected. If an employer has failed to abate a violation, the compliance ofﬁcer informs the employer that he or she is subject to ‘‘Failure to Abate’’ alleged violations, and additional daily penalties may be incurred while such failure to abate the violation continues [3]. © 2003 by Marcel Dekker, Inc.

B. Opening Conference When the OSHA compliance ofﬁcer arrives at the establishment, he or she will display ofﬁcial credentials and ask to meet with an appropriate employer representative. In the opening conference, the compliance ofﬁcer will explain how the establishment was selected. The compliance ofﬁcer also will ascertain whether an OSHA-funded consultation visit is in progress or whether the facility is pursuing or has received an inspection exemption through the consultation program. If so, the inspection may be terminated. Before the inspection, the compliance ofﬁcer explains the purpose of the visit, the scope of the inspection, and the standards that apply. The employer will be given information on how to obtain a copy of applicable safety and health standards as well as a copy of any complaint that may be involved (with the employee’s name deleted). The employer will be asked to select an employer representative to accompany the compliance ofﬁcer during the inspection. An authorized employee representative also is given an opportunity to attend the opening conference and to accompany the compliance ofﬁcer during the inspection. If a recognized bargaining agent represents the employees, the agent ordinarily will designate the employee representative to accompany the compliance ofﬁcer. The Act does not require an employee representative for each inspection. Where there is no authorized employee representative, the compliance ofﬁcer must consult with a reasonable number of employees concerning safety and health matters in the workplace [3].

C. The Inspection Process The compliance ofﬁcer determines the route and duration of the inspection. While talking with employees, the compliance ofﬁcer makes every effort to minimize any work interruptions. The compliance ofﬁcer observes safety and health conditions and practices; consults with employees privately, if necessary; takes photos and instrument readings, examines records, collects air samples, measures noise levels, and surveys existing engineering controls; and monitors employee exposure to toxic fumes, gas, and dusts. An inspection tour may cover part or all of an establishment, even if the inspection resulted from a speciﬁc complaint, fatality, or catastrophe. Trade secrets observed by the compliance ofﬁcer will be kept conﬁdential. An inspector who releases conﬁdential information without authorization is subject to a $1,000 ﬁne and/or 1 year in jail. The employer may require that the employee representative have conﬁdential clearance for any area in question. Employees are consulted during the inspection tour. The compliance ofﬁcer may stop and question workers, in private, about safety and health conditions and practices in their workplaces. Each employee is protected under the Act from discrimination by the employer for exercising his or her rights. During the course of inspection, the compliance ofﬁcer will point out to the employer any unsafe or unhealthful working conditions observed. At the same time, the compliance ofﬁcer will discuss possible corrective action if the employer so desires. Some apparent violations detected by the compliance ofﬁcer can be corrected immediately. When they are corrected on the spot, the compliance ofﬁcer records such corrections to help judge good faith in compliance. Although corrected, the apparent violations © 2003 by Marcel Dekker, Inc.

may still serve as the basis for citation and, if appropriate, a notice of proposed penalty [3]. D.

Closing Conference

At the conclusion of the inspection, the compliance ofﬁcer conducts a closing conference with the employer and the employee representative. It is a time for free discussion of problems and needs, a time for frank questions and answers. The compliance ofﬁcer also will give the employer a copy of the employer rights and responsibilities following an OSHA inspection and will discuss brieﬂy the information in the booklet and will answer any questions. The compliance ofﬁcer discusses with the employer all unsafe or unhealthful conditions observed during the inspection and indicates all apparent violations for which a citation and a proposed penalty may be issued or recommended. The employer is informed of appeal rights. During the closing conference, the employer may wish to produce records to show compliance efforts and to provide information that can help OSHA determine how much time may be needed to abate all alleged violations. When appropriate, more than one closing conference may be held. This is usually necessary when health hazards are being evaluated or when laboratory reports are required. If an employee representative does not participate in either the opening or the closing conference held with the employer, a separate discussion is held with the employee representative, if requested, to discuss matters of interest to employees [3].

VI. STANDARDS RELATED TO SAFETY AND HEALTH HAZARDS IN THE WORKPLACE For the purpose of this chapter, food processing plants are covered under 29 CFR Parts 1902–1908, Regulatory Standards, Occupational Safety and Health Standards under 29 CFR Parts 1910. This is also commonly known as the General Industry Standard. Most common violations and standards will be discussed in this section [4]. A.

Section 5(a)(1): General Duties Clause

Section 5(a)(1) is commonly known as the General Duties Clause. It is used when no applicable standards can be found to cite a particular hazard. Section 5(a)(1) of the Act states each employer shall furnish to each employee employment and a place of employment which is free from recognized hazards that cause or are likely to cause death or serious physical harm to employees. B.

29 CFR Part 1903: Inspection, Citations, and Proposed Penalties

The purpose of Part 1903 is to prescribe rules and to set forth general enforcement policies rather than substantive or procedural rules. Such policies may be modiﬁed in speciﬁc circumstances where the Secretary of Labor or a designee determines that an alternative course of action would better serve the objective of the Act. Section 1903.2. This standard requires each employer to post and keep posted a notice informing employees of the protections and obligations provided under the Act, and to provide assistance and information, including copies of the Act and of speciﬁc © 2003 by Marcel Dekker, Inc.

safety and health standards. If there is any question, employees should contact the employer or the nearest ofﬁce of the Department of Labor. Such notice shall be posted by the employer in each establishment in a conspicuous place or places where notices to employees are customarily posted. This poster is commonly known as the OSHA poster. This standard also requires the employer who has obtained copies of the Act and applicable rules and regulations to make such rules and regulations available upon request to any employee or their authorized representative. Any employer failing to comply with the provision of this section may be subject to citation and penalty. Section 1903.8. This section requires the employer to allow a representative of the employees an opportunity to accompany the compliance safety and health ofﬁcer during the physical inspection of any workplace for the purpose of aiding such inspection. Section 1903.19. Inspections by OSHA are intended to result in the abatement of violations of the Occupational Safety and Health Act of 1970. Within 10 calendar days after the abatement date, the employer must certify to OSHA (state plans may vary) that each cited violation has been abated. The employer’s certiﬁcation that abatement is completed must include, for each cited violation, the following information: (1) the employer’s name and address; (2) the inspection number to which the submission relates; (3) the citation and item numbers to which the submission relates; (4) a statement that the information submitted is accurate; and (5) the signature of the employer or authorized representative. There are times when abatement plans may be required; this is indicated on the citation and the employer must submit an abatement plan for each cited violation within 25 calendar days (state plans may vary) from the ﬁnal order of the date. An employer who is required to submit an abatement plan may also be required to submit periodic progress reports for each cited violation, as indicated on the citation. The date on which an initial progress report must be submitted may be no sooner than 30 calendar days after submission of abatement plan (states plans may vary). The employer is also required to inform affected employees and their representative(s) about abatement activities by posting a copy of each document submitted to the agency or a summary of the document near the place where violation occurred.

C. 29 CFR Part 1904: Recording and Reporting Occupational Injuries and Illness OSHA’s rule addressing the recording and reporting of occupational injuries and illnesses affects approximately 1.4 million establishments. A number of speciﬁc industries in the retail, services, ﬁnance, insurance, and real estate sectors are now classiﬁed as low-hazard industries and are exempt from most requirements of the rules, as are small businesses with 10 or fewer employees. On January 1, 2002, OSHA enacted a whole new set of rules replacing the old recording and reporting system—except for key provisions covering hearing loss and musculoskeletal disorders, which OSHA has delayed for one year while the agency reconsiders these issues. The newly revised rules improve employment, call for greater employee privacy protection, create simpler forms (OSHA 300, 301, 300A), provide clearer regulatory requirements, and allow employers more ﬂexibility to use computers to meet OSHA regulatory requirements. State programs will have six months to adopt the federal © 2003 by Marcel Dekker, Inc.

rules or come up with their own systems as effective as the federal system. To know more about these new rules, go to: www.OSHA.gov or www.DOL.gov. D.

29 CFR Part 1910: Occupational Safety and Health Standards

Section 6(a) of the Williams–Steiger Occupational Safety and Health Act of 1970 allows the Secretary of Labor to promulgate occupational safety and health standards. Title 29 CFR 1910 is commonly known as the General Industry Standards [2]. Section 1910.1020: Keeping Medical Records. This section discusses the requirements regarding how the employer shall keep medical records. Section 1910.1020(d)(1)(i). This standard requires the employer to preserve and maintain medical records for each employee for at least the duration of employment plus 30 years. Exception to this paragraph include health insurance claims records maintained separately from the employer’s medical program and its records as well as ﬁrst aid records if made on-site by a nonphysician and maintained separately from the employer’s medical program and its records. The medical records of employees who have worked less than 1 year for the employer are provided to the employee upon termination of employment. Section 1910.1020(d)(1)(ii). This standard requires the employer to preserve and maintain each employee’s exposure record for at least 30 years. Exceptions to this paragraph include 1. 2. 3.

Background data to environmental (workplace) monitoring or measuring, such as laboratory reports and work sheets Material safety data sheets and records concerning the identity of a substance or agent Biological monitoring results designed as exposure records by speciﬁc occupational safety and health standards, which shall be preserved and maintained as required by the speciﬁc standard

Section 1910.1020(g)(1)(i). This standard requires the employer to inform current employees upon their ﬁrst entering into employment and at least annually thereafter of the existence, location, and availability of any records covered by 29 CFR 1910.1020. E.

Subpart D: Walking/Working Surfaces

Slips, trips, and falls are among the most reported causes of occupational injuries. Falls are not always from elevation. Many falls are at the same level as slips and trips. Section 1910.22(a)(1). This standard requires all places of employment, passageways, storerooms, and services be kept clean and orderly and in a sanitary condition. Poor housekeeping could be one of the biggest elements contributing to an unsafe working place. Section 1910.22(a)(2). This standard requires the ﬂoor of every workroom be maintained in a clean and, so far as possible, a dry condition. Section 1910.22(d)(1). This standard requires every building or structure used for mercantile trade, business, industrial use, or storage to post the load limit signs approved by the building ofﬁcial in a conspicuous place in each space to which they relate. Section 1910.23(a)(1). This standard requires every stairway ﬂoor opening be guarded by a standard railing. © 2003 by Marcel Dekker, Inc.

Section 1910.23(c)(1). This standard requires every open-sided ﬂoor or platform that is 4 ft or more above the adjacent ﬂoor or ground level be guarded by a standard railing. Section 1910.23(c)(3). This standard requires that open-sided ﬂoors, walkways, platforms, or runways which are above or adjacent to dangerous equipment, pickling or galvanizing tanks, degreasing units, and other similar hazards are guarded with a standard railing and toe board. This is regardless of height. Section 1910.23(d)(1). This standard requires that every ﬂight of stairs having four or more risers be equipped with standard stair railings or handrails, according to the requirements as listed under Section 1910.23(d)(1)(i)–(v). Section 1910.24(b). This standard requires ﬁxed stairs be provided for access from one structure to another where operations necessitate regular travel between levels, and for access to operating platforms at any equipment which require attention routinely during operations. Fixed stairs shall also be provided 1. Where access to elevation is daily, or at each shift, for such purposes as gauging, inspection, regular maintenance, etc. 2. Where such work may expose employees to acids, caustics, gases, or other harmful substances 3. Where the carrying of tools or equipment by hand is normally required Section 1910.25. This section is intended to prescribe rules and establish minimum requirements for the construction, care, and use of common types of portable wood ladders. Subsection 1910.25(b)(2)(xv) requires that a ladder which is used to gain access to a roof shall extend at least 3 ft above the point of support, at cave, gutter, or rooﬂine. Section 1910.26. This standard requires metal ladders be designed without structural defects or have accident hazards such as sharp edges, burns, etc. The metal selected shall be of sufﬁcient strength to meet the test requirements and shall be protected against corrosion unless inherently corrosion-resistant. F.

Subpart E: Means of Egress

A means of egress is a continuous and unobstructed way of exit travel from any point in a building or structure to a public way. This consists of three separate and distinct parts: the way of exit access, the exit, and the way of exit discharge. A means of egress comprises the vertical and horizontal ways of travel and shall include intervening room spaces, doorways, hallways, corridors, passageways, balconies, ramps, stairs, enclosures, lobbies, escalators, horizontal exits, courts, and yards. Section 1910.37(f)(1). This standard requires all exits shall be so located and exit access be arranged so that exits are readily accessible at all times. The most common problem found is blocked exits which are not readily accessible. Section 1910.37(f)(6). This standard requires the minimum width of any way of exit access shall in no case be less than 28 in. Section 1910.37(q). This standard requires exits shall be marked by a readily visible sign. Any door, passage, or stairway that is neither an exit nor a way of exit access, which is so located or arranged as to be likely to be mistaken for an exit, shall be identiﬁed by a sign reading ‘‘not an exit’’ or similar designation. It can also be identiﬁed by a sign indicating its actual character, such as ‘‘to basement,’’ ‘‘storeroom,’’ ‘‘linen closet,’’ or the like. © 2003 by Marcel Dekker, Inc.

Section 1910.38(a). This standard applies to all emergency action plans required by a particular OSHA standard. The emergency action plan shall be in writing except for those employers with 10 or fewer employees, who may communicate the plan orally to employees. The following elements at a minimum shall be included in the plan: 1. 2. 3. 4. 5. 6.

Emergency escape procedures and emergency escape route assignments Procedures to be followed by employees who remain to operate critical plant operations before they evacuate Procedures to account for all employees after emergency evacuation has been completed Rescue and medical duties for those employees who are to perform them The preferred means of reporting ﬁres and other emergencies Names or regular job titles of persons or departments who can be contacted for further information or explanation of duties under the plan

Section 1910.38(a)(5). This standard requires that the employer, before implementing the emergency action plan, shall designate and train a sufﬁcient number of persons to assist in the safe and orderly emergency evacuation of employees. Section 1910.38(b). This standard applies to all ﬁre prevention plans required by a particular OSHA standard. The ﬁre prevention plan must be in writing, except for employers with 10 or fewer employees, who may communicate the plan orally to employees. The following elements at a minimum shall be included in the plan: 1.

2. 3.

A list of major workplace ﬁre hazards and their proper handling and storage potential ignition sources and their control procedures as well as the type of ﬁre protection equipment or systems which can control a ﬁre involving them Names or regular job titles of those personnel responsible for maintenance of equipment and systems installed to prevent or control ignitions or ﬁres Names or regular job titles of these personnel responsible for control of fuel source hazards

Section 1910.38(b)(4). This standard requires the employer to apprise employees of the ﬁre hazards of the materials and processes to which they are exposed. The employer shall also review with each employee upon initial assignment those parts of the ﬁre prevention plan for which the employee must know to protect the employee in the event of emergency. G.

Subpart G: Occupational Health and Environmental Control

Section 1910.95. Protection against noise exposure shall be provided when employees are exposed to a sound level exceeding an 8-hr time-weighted level of 85 decibels (the action level) or an 8-hr time-weighted level of 90 decibels (the permissible exposure level). Employers are required to monitor and determine if employees were being exposed to noise over the action level. The employer shall notify each employee exposed at or above the action level. The employers are required to establish and maintain an audiometric testing program and establish a valid baseline audiogram within 6 months of an employee’s ﬁrst exposure at or above the action level. At least annually after obtaining the baseline audiogram, the employer shall obtain a new audiogram for each affected employee. Hearing protectors shall be available to all employees exposed to an 8-hr time-weighted level of 85 decibels or greater at no cost to employees. Hearing protectors shall be replaced as necessary. The employer shall institute an annually repeated training program for the © 2003 by Marcel Dekker, Inc.

employees who are exposed to noise at or above the action level and to ensure employee participation in such training program. Section 1910.95(c). This standard requires the employer to administer a continuing, effective hearing conservation program whenever employees’ noise exposure equal to or exceeding an 8-hr time-weighted level of 85 decibels measured on the A scale, or equivalently a dose of 50%. The requirements are listed in 29 CFR 1910.95(c)–(o). H. Subpart H: Hazardous Materials Section 1910.101(a). This standard requires the employer to determine whether compressed gas cylinders under its control are in a safe condition to the extent that can be determined by visual inspection. Visual and other inspections shall be conducted as prescribed in the hazardous regulations of the Department of Transportation (49 CFR 171–179 and 14 CFR 103). Where those regulations are not applicable, visual and other inspections shall be conducted in accordance with Compressed Gas Association Pamphlets C-6-1968 and C-8-1962. Section 1910.101(b). This standard requires the employer to follow the Compressed Gas Association Pamphlet P-1-1965 for the in-plant handling, storage, and utilization of all compressed gases in cylinders, portable tanks, rail tankcars, or motor vehicle cargo tanks. Section 1910.106. This section discusses the ﬂammable and combustible liquids separated into different classes and their handling and storage requirements. Section 1910.119. This standard, commonly known as the Process Safety Management (PSM) standard, contains the requirements for preventing or minimizing the consequence of catastrophic releases of toxic reactive, ﬂammable, or explosive chemicals. These releases may result in toxic exposure, ﬁre, or explosive hazards. There are 137 chemicals listed and regulated by this standard. Their total quality if exceeding the allowed amount is subject to all requirements of the standards. Many companies will try to substitute lesser hazardous chemicals in order to avoid complying with this standard because compliance requires a lot of work and is often quite expensive. When they have to have one of the 137 regulated chemicals on site they will try to keep the total quantity lower than the regulated level so that the standard will not apply. Those who have operations covered under this standard are subjected to all the requirements of this standard. The subjects of various subsections include 1910.119(c) 1910.119(d) 1910.119(e) 1910.119(f) 1910.119(g) 1910.119(h) 1910.119(i) 1910.119(j) 1910.119(k) 1910.119(l) 1910.119(m) 1910.119(n) 1910.119(o) 1910.119(p)

Employee participation Process safety information Process hazard analysis Operating procedures Training Contractors Pre–start-up safety review Mechanical integrity Hot work permit Management of change Incident investigation Emergency planning and response Compliance audits Trade secrets

© 2003 by Marcel Dekker, Inc.

Section 1910.120. This section covers 1.

2. 3. 4.

5.

This standard is commonly known as the Hazwooper Standard.

Cleanup operations required by a governmental body—whether federal, state, local, or other—involving hazardous substances. These include cleanups conducted at uncontrolled hazard waste sites, any site on the state priority sites list, sites recommended for the Environmental Protection Agency (EPA) National Priorities List (NPL), and sites which are identiﬁed for initial government investigation before substance has been ascertained. Corrective actions involving cleanup operations at sites covered by the Resources Conservation and Recovery Act of 1976. Voluntary cleanup operations at sites recognized by federal, state, local, or other governmental bodies as uncontrolled hazardous waste sites. Operations involving hazardous waste that are conducted at treatment, storage, or disposal (TSD) facilities regulated by 40 CFR Parts 264 and 265 pursuant to the Resource Conservation and Recovery Act (RCRA) or by agencies under agreement with EPA to implement RCRA regulations. Emergency response operations for release of, or substantial threats of release of, hazardous substances without regard to the location of the hazard.

Most commonly used chemicals that are used as refrigerants, such as anhydrous ammonia, and chemicals used for cleaning-in-process (CIP) for cleanup, such as chlorine or ozone, could be subjected to Section 1910.119 and 1910.120 requirements. I.

Subpart I: Personal Protective Equipment

This standard requires the employer to provide protective equipment including personal protective equipment (PPE) for eye, face, head, and extremities. Protective clothing, respiratory devices, and protective shields and barriers shall be used and maintained in a sanitary and reliable condition wherever it is necessary. Such equipment protects individuals from process or environmental hazards, chemical hazards, radiological hazards, or mechanical irritants encountered in a manner capable of causing injury or impairment in the function of any part of the body through absorption, inhalation, or physical contact. Section 1910.132(d)(1). This standard requires the employer to assess the workplace to determine if hazards are present, or are likely to be present, which would necessitate the use of personal protective equipment. If such hazards are present, or likely to be present, the employer shall 1. 2. 3.

Select and have each affected employee use the type(s) of PPE that will protect the affected employee from the hazard identiﬁed in the hazard assessment Communicate selection decisions to each affected employee Select PPE that properly ﬁts each affected employee

Section 1910.132(d)(2). This standard requires the employer to verify that the required workplace hazard assessment has been performed through a written certiﬁcation. This certiﬁcation should include the name of the person certifying that evaluation has been performed, the date(s) of hazard assessment, and a title that identiﬁes the document as a certiﬁcation of hazard assessment. Section 1910.132(f). This standard requires the employer to provide training to © 2003 by Marcel Dekker, Inc.

each employee who is required by 29 CFR 1910.132 to use PPE. These employees shall be trained to know at least the following: 1. 2. 3. 4. 5.

When PPE is necessary What PPE is necessary How to properly don, doff, adjust, and wear PPE The limitation of PPE The proper care, maintenance, useful life, and disposal of the PPE

Section 1910.133. This standard requires the employer to ensure that each affected employee uses appropriate eye or face protection when exposed to eye or face hazards from ﬂying particles, molten metal, liquid chemicals, acids or caustic liquids, chemical gases or vapors, or potentially injurious light radiation. Protective devices purchased after July 5, 1994 shall comply with American National Standard Institute (ANSI) Z87.1-1989. Section 1910.134. This section deals with the control of those occupational diseases caused by breathing air contaminated with harmful dusts, fogs, fumes, mists, gases, smokes, sprays, or vapors. The primary objective is to prevent atmospheric contamination. This shall be accomplished as far as feasible by accepted engineering control measures. When effective engineering controls are not feasible or while they are being instituted, appropriate respirators shall be used pursuant to the requirements of this standard. Section 1910.135. This standard requires the employer to ensure that each affected employee wears a protective helmet when working in areas where there is a potential for injuries to the head from falling objects. Protective helmets purchased after July 5, 1994 shall comply with ANSI Z89.1-1969. Section 1910.136. This standard requires the employer to ensure each affected employee uses protective footwear when working in areas where there is a danger of foot injuries due to falling or rolling objects, or objects piercing the sole, and where such employees’ feet are exposed to electrical hazards. Protective footwear purchased after July 5, 1994 shall comply with ANSI Z41.1-1967. Section 1910.138. This standard requires the employer to select and require employees to use appropriate hand protection when employees’ hands are exposed to hazards such as those from skin absorption of harmful substances, severe cuts or lacerations, severe abrasions, punctures, chemical burns, thermal burns, and harmful temperature extremes. J. Subpart J: General Environmental Controls Section 1910.141. This standard requires permanent places of employment to meet the minimum requirements of sanitation facilities. Section 1910.146. This standard contains the requirements for practice and procedures to protect employees in general industry from any operation of the workplace that contains the hazards of entry into permit-required conﬁned spaces. This section does not apply to agriculture, to construction, or to shipyard employment. A conﬁned space means a space that (1) is large enough and so conﬁgured that an employee can bodily enter and perform assigned work; (2) has limited or restricted means for entry or exit; and (3) is not designed for continuous employee occupancy. A permit-required conﬁned space means a conﬁned space that has one or more of the following characteristics: 1. Contains or has a potential to contain a hazardous atmosphere 2. Contains a material that has the potential for engulﬁng an entrant © 2003 by Marcel Dekker, Inc.

3.

4.

Has an internal conﬁguration such that an entrant could be trapped or asphyxiated by inwardly converging walls or by a ﬂoor which slopes downwards and tapers to a smaller cross-section Contains any other recognized serious safety or health hazards

If such a hazard exists in the workplace, the employer is required to comply with the following provisions: 1910.146(d) Requires the employer to establish a permit space program 1910.146(e) Requires the employer to document the completion of measurements required by 29 CFR 1910.146(d)(3) by preparing entry permits before entry 1910.146(f) Requires the employer to establish entry permit document compliance of this section 1910.146(g) Requires the employer to provide training so that all employees whose work is regulated by this standard acquires the understanding, knowledge, and skills necessary for the safe performance of the duties assigned under this standard 1910.146(h) Requires the employer to train authorized entrants to understand their duties 1910.146(i) Requires the employer to train attendants to understand their duties 1910.146(j) Requires the employer to train entry supervisors to understand their duties 1910.146(k) Requires the employers to train employees who are entering the permit space to perform rescue services and make training available to have persons other than their employees perform permit space rescue Section 1910.147. This standard is commonly known as the Control of Hazardous Energy Lock-Out/Tag-Out (LOTO) Standard. This standard covers the servicing and maintenance of machines and equipment in which the unexpected energization or startup of the machines or equipment, or release of stored energy, could cause injury to employees. This standard establishes the minimum performance requirements for the control of such hazardous energy. Appendix A to 1910.147 states a typical minimal lockout procedure for reference. Section 1910.147(c)(1). This requires the employer to establish a program consisting of energy control procedures, employee training, and periodic inspections. Such a program ensures that all energy sources are isolated before any employee performs servicing or maintenance on equipment or a machine, where the unexpected energizing, startup, or release of stored energy could occur and cause injury to employee. Section 1910.147(c)(7). This standard requires the employer to train and to ensure that the purpose and function of the energy control program is understood by employees and that the knowledge and skills required for the safe application, usage, and removal of the equipment are acquired by employees. K.

Subpart K: Medical and First Aid

Section 1910.151. This standard sets requirements for medical and ﬁrst aid. Section 1910.151(c). This standard requires the employer to provide suitable facilities for quick drenching or ﬂushing of the eyes or body when the eyes or body may be exposed to injuries from corrosive materials. © 2003 by Marcel Dekker, Inc.

L.

Subpart L: Fire Protection

Section 1910.155. This standard sets the requirements for ﬁre brigades and all portable and ﬁxed ﬁre suppression equipment, ﬁre detection systems, and ﬁre or employee alarm systems installed to meet the ﬁre protection requirements of 29 CFR 1910. Section 1910.156. This standard contains the requirements for the organization, training, and personal protective equipment of ﬁre brigades whenever established by an employer. Section 1910.157. This standard applies to the placement, use, maintenance, and testing of portable ﬁre extinguishers provided for employee use. Where the employer has an emergency action plan and a ﬁre prevention plan which meets the requirements of 29 CFR 1910.38, then only the requirements of 1910.157(e) and (f) apply. Section 1910.159. This section sets the requirements for all automatic sprinkler systems installed to meet the particular OSHA standard. Section 1910.164. This standard requires all automatic ﬁre detection systems installed to meet the requirements of the OSHA standard. Section 1910.165. This standard applies to all emergency employee alarms installed to meet a particular OSHA standard. The requirements are that maintenance, testing and inspection shall be applied to all local ﬁre alarm signaling systems used to alert employees, regardless of other functions of the system. M. Subpart O: Machinery and Machine Guarding Section 1910.212(a)(1). This standard requires the employer to provide one or more methods of machine-guarding to protect the operator and other employees in the machine area from hazards such as those created by point of operation, ingoing nip points, rotating parts, ﬂying chips, and sparks. Section 1910.212(a)(2). This standard requires the guards for the machine be afﬁxed to the machine where possible or secured elsewhere if for any reason attachment to the machine is not possible. The guard shall be such that it does not offer an accident hazard in itself. Section 1910.215. This standard sets the minimum requirements for safeguarding of abrasive wheels. Speciﬁc requirements for maximum exposure angles, tongue guards, tool rests, and other minimum safety requirements are listed in different tables and ﬁgures in this standard. Section 1910.219(d)(1). This standard sets the guarding requirements for pulleys that are 7 ft or less from the ﬂoor or working platform. Where the point of contact between belt and pulley is more than 6 in. from the ﬂoor or platform, it may be guarded with a disk covering the spokes. Section 1910.219(e)(1). This standard covers guards on horizontal belts and ropes. On horizontal belts and ropes, where both runs of horizontal belts are 7 ft or less from the ﬂoor level, the guard shall extend to at least 15 in. above the belt or to a standard height as listed in Table 0-12 (Table of Standard Materials and Dimensions) [5]. However, when both runs of a horizontal belt are 42 in. or less from the ﬂoor, it shall be fully enclosed. Section 1910.219(i)(1). This standard requires all revolving collars including split collars, be cylindrical and that crews or bolts used in collars shall not project beyond the largest periphery of the collar. © 2003 by Marcel Dekker, Inc.

Section 1910.219(i)(2). This section requires the couplings shall be so constructed as to present no hazard from bolts, nuts, set screws, or revolving surfaces. Bolts, nuts, and set screws will, however, be allowed where they are covered with safety sleeves or where they are used parallel with the shafting and are countersunk or else do not extend beyond the ﬂange of the coupling.

N.

Subpart P: Hand and Portable Power Tools

Section 1910.242. This standard requires the employer to be responsible for the safe condition of the tools and equipment used by employees, including tools and equipment which may be furnished by employees. Section 1910.243. This standard requires the guarding of all portable, powerdriven circular saws having a blade diameter greater than 2 in. It shall be equipped with a guard above and below the base plate or shoe. The upper guard shall cover the saw to the depth of the teeth, except for the minimum arc required to permit the base to be tilted for bevel cuts. The lower guard shall cover the saw to the depth of the teeth, except for the minimum arc required to allow proper retraction and contact with the work. When the tool is withdrawn from the work area, the lower guard must automatically and instantly return to covering position.

O.

Subpart Q: Welding, Cutting, and Brazing

Section 1910.252. This standard provides the basic precautions and special precautions of the ﬁre protection and prevention responsibilities of welders and cutters and their supervisors, which includes outside contractors and those in management on whose property cutting and welding are to be performed. The standards for ﬁre prevention in use of cutting and welding processes are listed under National Fire Protection Association (NFPA) Standard 51B, 1962, which is incorporated as reference as speciﬁed in 29 CFR 1910.6. Section 1910.253(b)(2)(ii). This standard requires that cylinders kept inside buildings be stored in a well-protected, well-ventilated, dry location at least 20 ft from high combustibles such as oil or excelsior. Assigned storage spaces shall be located where cylinders will not be knocked over or damaged by passing or falling objects or subject to tampering by unauthorized persons. Section 1910.253(b)(4)(i). This standard requires that oxygen cylinders not be stored near highly combustible material, especially oil and grease; or near reserved stocks of carbide and acetylene or other fuel-gas cylinders, or near any other substance likely to cause or accelerate ﬁre, or in an acetylene generator compartment. Section 1910.253(b)(4)(iii). This standard requires the storage of oxygen cylinders to be separated from fuel-gas cylinders or combustible materials by a minimum of 20 ft or by a noncombustible barrier at least 5 ft high, having a ﬁre resistant rating of at least one-half hour. Section 1910.253(b)(5). This standard requires cylinders, cylinder valves, couplings, regulators, hoses, and similar apparatus be kept free from oily or greasy substances. Organic materials such as oil and grease can cause oxygen to self-ignite and will be an explosion hazard. © 2003 by Marcel Dekker, Inc.

P.

Subpart S: Electrical Safety

This subpart addresses electrical safety requirements that are necessary for the practical safeguarding of employees in their workplaces and is divided into ﬁve major divisions as follows: 1. Design safety standards for electrical systems contained in Sections 1910.302 through 1910.330 2. Safety-related work practices contained in Sections 1910.331 through 1910.360 3. Safety-related maintenance requirements contained in Sections 1910.361 through 1910.380 4. Safety requirements for special equipment contained in Sections 1910.381 through 1910.398 5. Deﬁnitions applicable to each division contained in Section 1910.399 Section 1910.303(b)(1). This standard requires the employer to perform inspections to identify hazards. It requires electrical equipment to be free from recognized hazards that are likely to cause death or serious physical harm to employees. Section 1910.303(b)(2). This standard requires listed or labeled equipment to be used or installed in accordance with any instructions included in the listing or labeling. Section 1910.303(e). This standard requires that electrical equipment may not be used unless the manufacturer’s name, trademark, or other descriptive marking which may identify the organization responsible for the product is placed on the equipment. Other markings shall be provided giving voltage, current, wattage, or other rating as necessary. Section 1910.303(f). This standard requires each disconnecting means be legibly marked to indicate its purpose, unless located and arranged so the purpose is evident. Each service, feeder, and branch circuit and its disconnecting means shall be legibly marked to indicate its purpose. Section 1910.303(g). This standard requires that for equipment rated 600 mV normal, sufﬁcient access and workspace shall be provided and maintained to permit ready and safe operation and maintenance of such equipment. Section 1910.304(a)(2). This standard requires that no ground conductor may be attached to any terminal or lead so as to reverse designated polarity. Section 1910.304(f)(4). This standard requires the path to ground from circuits, equipment, and enclosures be permanent and continuous. Section 1910.305(a)(2)(iii)(F). This standard requires that lamps used for general illumination be protected from accidental contact or breakage. Protection shall be provided by elevation of at least 7 ft from normal working surface or by a suitable ﬁxture or lamp holder with a guard. Section 1910.305(b)(1). This standard requires conductors entering any box, cabinets, or ﬁttings be protected from abrasion, and any openings through which conductors enter shall be effectively closed. Accumulated dust will cause an arc between conductors and may then cause an electrical ﬁre. Section 1910.305(b)(2). This standard requires all pull boxes, junction boxes, and ﬁttings are to be provided with covers approved for the purpose. If metal covers are used, they must be grounded. Section 1910.305(e)(1). This standard requires that cabinets, cutout boxes, ﬁttings, boxes, and panel board enclosures in damp or wet locations be installed so as to prevent © 2003 by Marcel Dekker, Inc.

moisture or water from entering and accumulating within the enclosures. In wet locations the enclosures shall be weatherproof. Section 1910.305(g). This standard sets the requirement for the use of ﬂexible cords and cables. The most commonly found violation, in Section 1910.305(g)(1)(iii), includes ﬂexible cords and cables used as a substitute for the ﬁxed wiring of a structure. This subsection addresses 1. 2. 3. 4.

Flexible cords and cables running through holes in walls, ceilings, or ﬂoors Flexible cords and cables running through doorways, windows, or similar openings Flexible cords and cables attached to building surfaces Flexible cords and cables concealed behind buildings, walls, ceilings, or ﬂoors

Section 1910.332(a). This standard requires the employer to train employees who face a risk of electrical shock that is not reduced to a safe level by the electrical installation requirements of Sections 1910.303 through 1910.308. Section 1910.322(b)(1). This standard requires the employer to train employees in and become familiar with the safety-related work practices required by Sections 1910.331 through 1910.335. Section 1910.322(b)(2). This standard sets additional requirements for the employer to train unqualiﬁed employees who are covered by Section 1910.322(a) but who are not qualiﬁed persons. They shall be trained and be familiar with any electrically related safety practices not speciﬁcally addressed by Sections 1910.331 through 1910.335 but which are necessary for their safety. Section 1910.334(a)(2)(ii). This standard requires the employer, during visual inspection, to remove any defective or damaged equipment that might expose an employee to injury. No employees may use such until appropriate repairs and tests are done to render the equipment safe. Q.

Subpart Z: Toxic and Hazardous Substances

Section 1910.1030. This standard is commonly known as the Bloodborne Pathogen Standard. It applies to all occupational exposure to blood or other potentially infectious materials as deﬁned in 1910.1030(b). This standard also covers but is not limited to ﬁrst responders and employees who are designated as ﬁrst-aid providers in their job description. Section 1910.1030(c). This standard requires employers to establish a written exposure control plan designed to eliminate or minimize employee exposure. Section 1910.1030(d). This standard discussed the different methods of compliance such as universal compliance, engineering, and work practice controls. Section 1910.1030(f). This standard requires the employer to make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure, and postexposure evaluation and follow-up to all employees who have had an exposure incident. Section 1910.1030(g)(1). This standard requires the employer to afﬁx warning labels and signs to containers of regulated waste; refrigerators and freezers containing blood or other infectious materials; and other containers used to store, transport, or ship blood or other potentially infectious materials. Section 1910.1030(g)(2). This standard requires employers to ensure all employees with occupational exposure participate in a training program, which must be provided © 2003 by Marcel Dekker, Inc.

at no cost to the employee and be held during working hours. Such training shall be repeated annually. The elements of the minimum training program requirements are listed under Sections 1910.1030(g)(2)(vii)A–N. Section 1910.1030(h). This standard requires the employer to establish and maintain accurate records for each employee with occupational exposure, in accordance with 29 CFR 1910.20, for the duration of employment plus 30 years. Section 1910.1200. This standard is commonly known as the Hazard Communication Standard or Employee Right-to-Know Standard. The purpose of this standard is to ensure that the hazards of all chemicals produced or imported are evaluated, and that information concerning their hazards is transmitted to employers and employees. This is the most cited standard, topping any other OSHA citations. Section 1910.1200(e)(1). This standard requires the employer to develop and maintain at each workplace, a written hazard communication program which describes the criteria set in 29 CFR Sections 1910.1200(f)–(h) for labels and other forms of warning, material safety data sheets, and employee information and training. Section 1910.1200(f)(5). This standard requires the employer to ensure that each container of hazardous chemicals in the workplace is labeled, tagged, or marked with the following information: (1) identity of the hazardous chemical(s) contained therein, (2) appropriate hazard warnings or words, pictures, symbols, or combination thereof that provide at least general information regarding the hazards of the chemicals and which, in conjunction with other information immediately available to employees under the hazard communication program, provide employees with speciﬁc information regarding the physical hazards of the hazardous chemical(s). Section 1910.1200(g)(8). This standard requires the employer to maintain in the workplace copies of the required material safety data sheets for each hazardous chemical and ensure that they are readily accessible during each work shift to employees when they are in their work area(s). Section 1910.1200(h)(1). This standard requires the employer to provide employees with effective information and training on hazardous chemicals in their work areas at the time of their initial assignment and whenever a new physical or health hazard the employees have not previously been trained about is introduced into their work area. The elements for minimum training requirements are listed under 29 CFR Sections 1910.1200(h)(3)(i)–(iv). This discussion represents some of the most cited violations of an OSHA inspection at the workplace. An effective safety and health program, discussed in the next section, could also contribute to a safer workplace [12].

VII. SUGGESTED ELEMENTS OF AN EFFECTIVE SAFETY AND HEALTH PROGRAM A. Management Commitment and Worker Involvement 1. Visible top management leadership 2. Employee involvement in structure and operation of program and in decisions that affect their safety and health 3. Clear worksite policy on safe and healthful work and working conditions 4. Goal(s) for safety and health program objectives for meeting goal(s) 5. Assignment and communication of responsibility for all aspects of program © 2003 by Marcel Dekker, Inc.

6. 7. 8. B.

Worksite Analysis 1. 2.

C.

Regular site safety and health inspection Reliable system for employees to report hazards and receive timely and appropriate response

Hazard Prevention and Control 1. 2. 3.

D.

Adequate authority and resources for parties to meet assigned responsibilities Identiﬁcation of managers, supervisors, and employees accountable for meeting responsibilities Annual program review to evaluate success in meeting goal(s) and objectives

Facility and equipment maintenance to prevent hazardous breakdowns Medical programs to minimize injury and illness Emergency plan and drills so that response of all parties will be second nature

Safety and Health Training 1. 2. 3.

Training for managers on their safety and health responsibilities Training for supervisors on their safety and health responsibilities and reasons for them Training for employees on general safety and health rules of worksite, speciﬁc site hazards, safe work practice to control exposure, and role in emergency situations

VIII. SAFETY RULES AND PRACTICES IN FOOD PROCESSING OPERATIONS A.

Employee Responsibilities

Under 29 CFR 1960.10, Employee Responsibilities and Rights, the Occupational Safety and Health Act requires each employee to comply with the standards, rules, regulations, and orders issued by the agency in accordance with Section 19 of the Act. Executive order 12196 held employees responsible for their own actions and conduct. Employees shall also use safety equipment, personal protective equipment, and other devices and procedures provided or directed by the agency and necessary for their protection. Employees shall have the right to report unsafe and unhealthful working conditions to appropriate ofﬁcials. They are protected by law from being discriminated against by their employer if they choose to exercise this right. B.

Protective Equipment and Clothing

Proper protective equipment and clothing can avoid many accidents. Many companies have formulated a program of safety for their employees and mandate the use of safety equipment in job performance. Safety equipment should meet the requirements of the American National Standard Institute requirement for safety equipment. Efﬁciency of performance can be increased and operating cost reduced by the application of proper training of workers. © 2003 by Marcel Dekker, Inc.

Safety equipment such as safety helmets (hats) must be worn for all jobs where carcasses or products are conveyed on noncaptive overhead rails and where employees drive ride-on industrial tractors. Helmets are recommended for all dressing ﬂoor and cooler operations. Safety glasses or a face shield should be used for the protection of eyes or face from damage or destruction by physical or chemical agents or by radiant energy. This is an integral part of any good industrial safety program. Hand protection can be achieved by using metal mesh gloves. These gloves are made from stainless steel that conforms to the shape of the hand and the ﬁngers to eliminate cutting injuries of workers’ hands. Various kinds of protective footwear are available on the market but steel-toed safety shoes are the best for impact protection. For work done under wet conditions, rubber boots or rubber shoes are available with steel box toes having similar impact speciﬁcation set by ANSI for foot protection. C. Handling of Tools There are many good reasons for the proper instruction and training of workers regarding their handling of both hand and power tools. The knife is one of the most commonly used tools in cutting. The careful use of the knife and observation of safe practices in cutting will prevent accidents. Abuse of knives may lead to an injury. Automated and handpowered equipment play a very important role in the food industry. Many automated tools are featured with safety switches, but that doesn’t mean one can ignore safely handling of the tools. Power tools should be positioned on retractable power lines. This will keep the equipment high above the head of the worker when not in use. Accidents are often caused by slipping, which throws the worker into the power tool, such as a saw. Waste and rubbish should be removed from the ﬂoor at regular intervals. Salt or other skid prevention materials should also be used to prevent slipping. Operators should know the safety factors as well as the care and maintenance of the power tools. Not paying attention to the moving and working parts of power tools is often the cause of accidents. Safety factors concerning the operation of the power tools should be observed. Factors needing attention include adjustment of the power tool, adjustment of guides, and adjustment of the tool support. Manufacturers produce a wide variety of grinders for the food services industry. The most important safety measure for meat grinders is to never operate a grinder without a feed pan or tray. When operating a large grinder, a fork or scoop should be used for feeding or loading. A slicing machine should be used to cut chilled or frozen boneless meats/ poultry into thin slices. It is important to remember to use the product pusher plate to slice end cuts. Fingers must be kept clear of the path of the blade. Also, do not disregard safety for speed. Before cleaning the slicing machine be sure the power is shut off to prevent accidental starting by touching the control switch.

IX. SOME PHYSICAL HAZARDS ENCOUNTERED AT THE WORKPLACE A. Electrical Hazards All portable hand tools and production tools should be equipped with polarized grounded receptacles. All extension cords should be the three-wire type designed to ﬁt the polarized receptacles. In most operations OSHA laws may require a lock-out/tag-out program to © 2003 by Marcel Dekker, Inc.

be implemented to prevent unexpected energization or start-up of the machines or equipment or release of stored energy. B.

Noise

Noise has been recognized as one of several causes of deafness. Employers should perform noise monitoring as required by law to determine if employees are being exposed to an 8-hr time-weighted level of 85 decibels or more. If so, a hearing conservation program should be implemented and personal protective equipment should be provided. C.

Pneumatic Stuffers

Pneumatic stuffers have enough wall thickness to withstand normal stufﬁng pressure. Older stuffers are sometimes reamed or honed as interior walls become pitted or irregular. State and federal laws require annual inspection of such devices to prevent explosion of the stuffers. D.

Retorts

Hot water circulation lines should be periodically checked for hammering problems and to determine the loss of wall thickness. All retort attachments should be periodically inspected for wear or cracking. Accumulation of water in insulated retorts will cause early deterioration of the lower metal portions. E.

Boiler Feedwater

Boiler care and maintenance procedures will vary with size and type of installation. Because water treatment chemicals are an extremely important consideration in both safety and life of boilers, qualiﬁed inspectors should be used to check the boiler regularly. F.

Conveyors

Conveyors present a special kind of hazard. Many conveyors are installed to transfer products from one place to another or from a live to a dead roller section. Guarding of the nip point of the rollers on the conveyors is necessary. It is also required by law to safeguard conveyors. All conveyors should be equipped with covers or electronically interlocking devices to prevent injury to workers’ hands. G.

Lifts and Hoists

Movement of material by lifts, hoists, and cranes requires careful safety scrutiny. Hoisting apparatus has been used sparingly in the meat industry. Most hoisting equipment found in the market conform with ANSI standards. Some common causes of breakdown of hoists are overloading, improvised or makeshift slinging, and using the wrong type cables for the size lifted. It is important to select the correct chain for the job. Most new chains have built-in safety and have a breaking point several times greater than the work load limits. Frequent inspection and replacement of nonfunctioning parts could make a difference in preventing accidents. © 2003 by Marcel Dekker, Inc.

X.

SOME CHEMICAL HAZARDS ENCOUNTERED AT THE WORKPLACE

All chemical hazards are covered under 29 CFR 1910.1200, Hazard Communication Standard, and the employer is required by law to educate employees on the health and physical hazards of the chemicals they use at their workplace. A. Anhydrous Ammonia Anhydrous ammonia is used as a refrigerant because of its efﬁciency in absorbing heat, its economy, and its plentiful supply. Anhydrous ammonia has a powerful corrosive action on tissue. One can smell odor starting at 20 parts per million (ppm). At 40 ppm a few individuals could suffer slight eye irritation. At 100 ppm noticeable eye and upper respiratory tract irritation may occur. At 700 ppm severe eye irritation may occur. At 5000 ppm serious edema, strangulation, and asphyxia may occur. B. Hydrogen Sulﬁde Hydrogen sulﬁde gas frequently accumulates in grease interceptor basins or in places where there are large surface areas of low grade fats. Locations where this gas may accumulate should have good ventilation. C. Liquid Petroleum Gas Liquid petroleum (LP) torches are frequently used in the meat industry. One great hazard of LP gases is that they are heavier than air and tend to pocket or cloud. A source of ignition will produce a serious explosion from a leaking container. All LP gases should be stored in a well-ventilated place. D. Methane Sewer gas or methane gas frequently accumulates in manholes. Therefore, before entering such conﬁned spaces one should follow proper procedures to check for atmospheric hazards. Title 29 CFR Section 1910.146 covers the requirements of entering a conﬁned space. E.

Carbon Dioxide

Carbon dioxide (CO2) tends to accumulate at low levels and at the bottoms of enclosures such as pits, silos, tanks, and the like. It is sometimes used in the packing industry for immobilizing animals and for quick-freezing or cooling fresh meats. Adequately ventilated areas will disperse the gas and prevent accumulation. F.

Carbon Monoxide

Carbon monoxide (CO) is a colorless, tasteless, and odorless gas, slightly lighter than air. It is formed by incomplete combustion of organic materials. Exposure of approximately 200 ppm will result in headache and nausea. Overexposure could result in death. © 2003 by Marcel Dekker, Inc.

G.

Nitrogen

Nitrogen is a colorless, odorless, and tasteless gas. Nitrogen is frequently used for gasﬂushing certain packaged products to exclude oxygen. Adequate ventilation should be provided when this gas is used. H.

Plastic Fumes

Fumes are generated when ﬂexible plastic fumes used in packing are heat-sealed. The fumes tend to accumulate in the immediate vicinity of heat elements. The fumes contain methylethyl ketone (MEK), toluene, propylacetate, or other solvents. Both MEK and toluene are known cancer-causing agents. These fumes are irritating to eyes and mucous membranes, and in high concentration can cause headache and drowsiness. Proper venting should be employed at the sealing area. XI. CONCLUSION There are many hazards at the workplace. Some topics, such as ergonomics and workplace violence, do not have a speciﬁc standard. Those hazards, however, are covered under Section (5)(a)(1), the general duties clause. Currently, there are only limited numbers of federal and state OSHA inspectors and certainly not enough to cover inspection of each and every workplace. In real-life situations, many different factors contribute to an unsafe work place or to a safer workplace. Safety is not the safety ofﬁcer’s sole responsibility. Everyone in the company, from the president to each employee, is responsible to participate and contribute to make the workplace safer for everyone. Keeping everyone safe at work will preserve America’s most important asset—its people—and keep America’s working force in a position of world leadership. REFERENCES 1. Public law 91-596, Occupational Safety and Health Act of 1970. 2. Title 29, Code of Federal Regulations, Part 1910. Occupational Safety and Health Standard for General Industry, Washington, DC: U.S. Government Printing Ofﬁce. 3. OSHA. Publication OSHA 2098 (revised). 4. OSHA. Accessed at www.osha.gov. 5. U.S. Federal Register, Vol 37, no 202, October 18, 1972, p 22292.

© 2003 by Marcel Dekker, Inc.

16 Worker Training in Sanitation and Personal Safety TIN SHING CHAO U.S. Department of Labor, Honolulu, Hawaii, U.S.A.

I.

INTRODUCTION

Marjorie Davison, a Food and Drug Administration (FDA) Food Safety Initiative education team leader, has said ‘‘The business of food safety education is to persuade or convince someone to change unsafe food handling behavior.’’ She also said ‘‘Not only must we provide people with information we must do it in a manner that results in changing unsafe food handling behaviors to safe food handling behaviors. Constant reinforcement of education messages is important to sustaining behavior change’’ [1]. A company-implemented program’s, e.g., food sanitation or safety program, success depends upon the informed participation of two elements of the employed personnel: (1) production workers who have been properly oriented to their jobs and trained sufﬁciently until they have established the correct work habits of proper sanitary procedures and (2) Supervisors, who should also lead by example because they need to inspire their workers in following the company’s established policy. II. EMPLOYEE RIGHTS Employees have rights which must be considered. In fact, some food processing plants develop operating goals to ensure that management efforts reﬂect employee rights and concerns as operating decisions are made. Federal and state laws are frequently updated to specify more clearly the legal rights of employees. Labor laws cover minimum wage, overtime hours, hiring practices, and many other issues in the area of employment management. Managers must not violate such employee rights when they pursue productivity and other operating goals. It may well be that federal, state, and local labor regulations will © 2003 by Marcel Dekker, Inc.

continue to increase and managers will need to further improve their employee management skills. Employees want to ‘‘feel good’’ about themselves. Many feel that they have a right to be trained for the job and, upon satisfactory completion, to be treated like professionals. Employees do beneﬁt from training. Effective training methods, coupled with reasonable policies and procedures, written job requirements, and similar tools of employee management go a long way in ensuring fair treatment and affording extra protection to both employee and employer. Today’s workforce may be better educated than ever before, but education has not replaced the need for training in the food processing industry. In the future, workers may be even better educated than they are today. Training will still be essential. The rapid growth of technology seems to make it impossible to provide the level of education and training the workforce of the future will need. Managers of today and tomorrow need to strengthen their professionalism. This need may be more signiﬁcant than ever for the manager who is determined to survive and succeed [2]. III. TRAINING AND COACHING Training can be deﬁned as the process of acquiring and developing skills, knowledge, and attitudes through instructional activities. It is usually distinguished from education in that education is deﬁned as learning that contributes to total life growth, while training is limited to acquiring or developing competencies that meet speciﬁc needs. However, such distinctions can be left to philosophical and academic discussions. Training will be viewed in this chapter as any activity that results in learning. The effectiveness of training will be measured by improved performance of the learner. This means that if knowledge, skills, and attitudes have not been improved, then nothing was learned or what was learned was of little value. If, on the other hand, the acquired knowledge does improve skills, strengthen knowledge, and develop desirable attitudes, then the training will be considered effective. Training, is performance based, utilizing the learning process to achieve improved employee performance. Training might occur for reasons other than to improve job performance. Training will be focused on achieving goals that are believed to be attainable through improved performance. Coaching can be deﬁned as the constant reinforcement of learning that was acquired through training. Coaching is what a manager or fellow employee says or does to encourage an employee to perform according to standards speciﬁed in the training. Through a training system, an employee learns how and why to perform in a speciﬁed manner. Through a coaching system, that same employee is challenged, encouraged, motivated, and reinforced to carry out what was learned. Coaching is usually done at work stations and often deals with a single skill. The objective of the manager or employee who is coaching is to make suggestions or reinforce performance that will result in improvement of a skill or work activity. A manager who learns to coach is concerned about positive human relations. Coaching is a supportive technique which is designed to encourage employees. Every employee needs moral support to feel that the work being performed is really meaningful. Coaching is a means of communicating that support. Employees never lose the need for feedback about their performance. Even though they have performed the same task correctly for many years, they will want to hear managers and coworkers express approval of their work. On the other hand, bad habits could be developed in time as the employee knows © 2003 by Marcel Dekker, Inc.

the job better. If a normal training session is conducted, the deﬁciency in performance may be exposed to others and the experienced employees may lose face. Training and coaching are basically line functions. That is, they are the responsibility of the managers who actually supervise the employees in the operations phase of the production process. Employees look to their supervisors on a daily basis for the standards of how to perform their jobs. They need coaching and feedback to feel that their work is important. While many companies have training personnel who are staff specialists, their primary role should be to support line managers and to assist them in accomplishing the line responsibilities of training and coaching [2]. IV. BENEFITS OF TRAINING Training beneﬁts the consumer, employees, and management. An organization that is training its personnel is constantly growing. There is excitement about the personal growth of everyone involved, and that excitement may become the basis for high morale and motivation. There are many beneﬁts of training. A. Cost Savings When training is well planned and carried out systematically, performance should improve and cost savings can be realized. Training can contribute to reduced labor costs if it discourages turnover and increases productivity. Employees tend to remain in jobs where they are learning and growing. B. Efﬁciency When an employee knows the job and performs it efﬁciently, managers will ﬁnd they have more time for planning and other management responsibilities. If the staff is incompetent, much of management’s time will be spent in close, direct supervision and in checking the work performed by employees. When employees have been trained to function as a skilled team, they will monitor their own performance and will accomplish their work, freeing management for other activities. C. Reduction of Stress, Turnover, and Absenteeism Employees become frustrated when they have difﬁculty performing their jobs. Such frustrations lead to job stress, which may show up in several ways. Employees experiencing job-induced stress may exhibit poor attitudes toward management and coworkers. They may be careless, which causes sloppy work, increases chances of an accident, and increases ﬂagrant violations of work rules. As the situation continues, tardiness and absenteeism often become a pattern. This creates scheduling difﬁculties and requires close supervision by management. If the situation is not corrected quickly, employees may resign or might need to be released. Turnover can be a major source of higher than necessary labor costs. Good training should reduce turnover because it reduces job stress. D. Job Advancement Some employees may be motivated by an opportunity for job advancement. Within a company there should be an opportunity for advancement and to show how training will help prepare employees for promotions. When upward advancement is limited because © 2003 by Marcel Dekker, Inc.

of the size of the operation, managers can show employees how they can advance laterally by cross-training. Generally, the more each employee knows how to do, the more productive the entire staff will be. E.

Safety and Sanitation Awareness

Training can overcome many safety and sanitation problems that result from uninformed or misinformed employees. Effective training experience leads to increased safety and sanitation awareness and improved safety and sanitation procedures. F.

Improved Relationships

When managers spend the time and money to provide systematic training activities, they are making an investment in their employees as well as in their own success. Also many staff members will appreciate management for providing them the opportunity to grow. Therefore, in developing and implementing a training session, management also learns something in the process. This mutual growth is the basis for an improved management– employee relationship. Both are striving toward common performance goals, and each party beneﬁts [2].

V.

PROBLEMS IN TRAINING

A.

Lack of Commitment

Perhaps the greatest obstacle to effective training in any company is the lack of management commitment to training. Many organizations, large and small, do not budget any money for training and only give lip service to its importance. Whenever proﬁts decline, the few dollars that may be allocated for employee training are among the ﬁrst expenses eliminated from the budget. Unfortunately many companies do not demonstrate a belief that training is a cost-effective venture. The lack of management commitment is understandable in many cases, because the training that managers themselves received has never been planned and executed. The emphasis has been on ‘‘time in training’’ rather than ‘‘mastery of competencies.’’ Just sitting in a classroom for a certain length of time does not guarantee that training is taking place. When training is designed to achieve performance-based results, it can be effective; a proper return on the training investment will be realized. B.

Lack of Know-How

Another hindrance to training is lack of know-how within many organizations. Every year, there are people without prior experience or training entering the food industry as investors, owners, and operators. These individuals have, in many cases, experienced great success because of the overall growth of the industry; however, they often have great difﬁculty in establishing realistic standards for their operations. Individuals with formal training and experience in the food industry often join these organizations and help ﬁll this void. Lack of know-how can, of course, result in lack of standards and low productivity within an organization. © 2003 by Marcel Dekker, Inc.

C. Lack of Resources Along with lack of know-how, training may be hindered by an apparent lack of resources. Organizations that have clear standards generally develop good company manuals and operating procedures. These become the basis for designing training programs. On the other hand, organizations that lack know-how often have no manual or operating procedures. If managers cannot agree on how the jobs should ideally be performed, management will likely avoid writing procedures. In their absence, training, when attempted, often becomes a futile effort. There are many good training resources available to managers interested in developing and implementing training activities. These materials can be purchased and adopted for use within the organization. As time passes, experience and trial and error will reﬁne the adaptations and provide the basis for tailor-made manuals and other company materials. D. Employee Resistance Employees may resist training and make it difﬁcult to attain performance levels that meet standards. This is likely to happen when training is poorly presented. Likewise, when trainees are embarrassed, feel ridiculed, or fear the loss of jobs, a resistance to training may be encountered. Employees are usually adults, and they expect to be treated as adults. Adults require clear logic and some self-direction to be receptive to learning. It is important to develop training techniques that take adult needs into consideration. Training that is designed to consider the employees’ needs along with those of management is likely to be readily accepted and welcomed. E.

Disorganization

Finally, training will not be fully effective if it is poorly organized. When inadequate planning leads to operating problems and management institutes a ‘‘crash’’ training effort, such attempts are frequently too little too late. Employees recognize the disorganization; they may lose interest and are not likely to take the training seriously. Training, to be fully effective, must be planned and executed on a systemic basis. This includes beginning training for new employees, continuing training for existing employees, and regular coaching for all employees [2]. VI. WHEN TRAINING WON’T WORK Not all performance problems can be corrected through training and coaching. Sometimes employees are fully aware of ways to perform their jobs but still fail to deliver that performance. Retraining is not the answer to this situation. On a one-to-one basis, coaching stands a somewhat better chance of getting results, but there may be other factors involved. Sometimes there are barriers to performance that make all training and coaching ineffective. Therefore, managers must analyze the cause of poor performance to determine whether training will be helpful. Two common causes of poor performance by trained employees are inadequate equipment to do the job the way they were taught and the lack of freedom to perform the job without supervisory harassment. While it is essential to train employees, it is equally important to provide them with all the equipment and materials they need to carry out their © 2003 by Marcel Dekker, Inc.

work. They also need enough freedom to demonstrate that management has conﬁdence in their ability to perform. There may be other causes of poor performance. When a performance problem is identiﬁed, the real cause should be determined so that a solution can be implemented. Training is only one alternative. Management must develop and accept standards which management and employees can live with and employees can achieve. Employee attitude can also cause training to fail. Some people have no regard for standards set by others. When possible, these individuals should be identiﬁed during the selection process and should be eliminated from further considerations; however, managers inherit such employees when they accept a position in an establishment where a previous manager has done an ineffective job of selection and training. In such cases, the manager must attempt to change attitudes or remove these employees from the group in order for group training and coaching to be effective [2].

VII. STAFF TRAINING Basic staff training is very important to staff development and should be a well-deﬁned process. The training process can be divided into three phases. The ﬁrst phase provides an orientation to the program. This initial phase includes a review of program history, structure, relationship to other programs, and statutory requirements. Speciﬁc emphasis should be on the program’s goals and objectives. A structured approach is beneﬁcial for the workers to be familiarized with the company’s requirements and how everyone could contribute to compliance of codes and requirements of federal and state laws. A basic knowledge on terms and industry jargon could also help workers ﬁt into the work environment smoothly and conﬁdently. For example, in the sanitation program, it would be a good idea to review the epidemiology of foodborne illness, including organisms, foods, and contributing factors and case studies. Basic food microbiology, including the effects of temperature, pH, water activity, and other hurdles and barriers to the survival and growth of foodborne pathogens, are appropriate subjects. Scientiﬁc journal articles in the ﬁeld of food microbiology, food technology, and hazard analysis and critical control point (HACCP) procedures should be made available to employees. The next phase of training should be on-the-job-training or actual application. Employees can put the theories and education into work practices. Whatever was taught to the employees they shall apply during real-world situations. The real test of knowledge is knowing what to do when things actually happen. Supervisors should also observe and evaluate employees on how well they follow the established procedures. Either a planned or a surprise inspection would be a good tool to evaluate and to help identify the need for retraining. Observation and measurements should be recorded in an unobtrusive manner during the entire food cycle or operations and communicated to employees when the evaluation is done. The ﬁnal phase of training is never ﬁnished. The standardization or retraining process should be repeated on an annual basis. The company should establish continuing education programs to keep staff current with the changing world and the latest information and technology pertaining to its program. Management level employees are encouraged to join professional associations and organizations of their trade and to network with other professionals. © 2003 by Marcel Dekker, Inc.

VIII. SANITATION TRAINING IN THE WORKPLACE A sanitation program should be planned and organized and treated as a part of the production process. It is essential for a product produced in a processing plant to be free of insect and rodent infestation as well as free of extraneous material and bacterial or other contamination. Sanitation should be described as a way of life. It is a matter of living in a clean manner. It affects all people everywhere. Sanitation as applied to food industries is the way people work and live at the plant and involves such things as (1) personal hygiene, (2) respect for the food and materials produced, (3) good appearance during operations, (4) soundness of equipment and structure of the building, and (5) adequate pest control. There are two overall methods of maintaining sanitation: corrective and preventative. Corrective maintenance of sanitation eliminates or diminishes undesirable situations only when the condition has been discovered. For example, one method of controlling rodents would be to wait until a mouse population is found to be ﬂourishing in a storage room and then carrying out the necessary steps to eliminate the rodents or lessen their numbers. The other and far superior method is to take preventative measures. This means a program is set up to prevent undesirable situations from occurring and to maintain the establishment in such a way that is not likely that such situations will occur. Preventative sanitation is the way of life in food processing plants. It is understood that difﬁculties are anticipated, but with everyone’s involvement all problems can be solved. Preventative sanitation is based on the recognition that at least 80% of the job is good housekeeping. The remaining 20% is an effective pest control program. The success of an organized sanitation program depends on the participation of all plant personnel, with a strong management leadership team spearheading the program. Training is also a key element for such a program to be successful. All supervisory personnel should share the responsibility of stimulating the interest of workers under them. Posters and bulletins are often a helpful reminder to their employees to practice sanitation procedures. Individual desire to work in a clean environment is also important for a program to be successful. Peer inﬂuence can be a very powerful tool for an employee to practice good sanitation. Individual instruction as on-the-job training will always remain another method in correcting unsatisfactory conditions. Like a chain, effective sanitation is only as strong as its weakest link. There is no magic formula or product. Sanitation is a way of life, not just to be practiced but to be lived. Like weeds in a garden, it requires constant attention. Remember that microbes are for the most part plant life and are subject to many of the same physical effects as higher plants. A good sanitation program can be either an offensive or defensive measure. Used offensively, it can result in better quality products with corresponding economic beneﬁts. If used only defensively, it becomes simply another costly part of the company’s overhead.

IX. SAFETY TRAINING IN THE WORKPLACE Safety in the workplace, speciﬁcally safety in food processing plants, was brought into the public’s eye in September of 1991. Right after the Labor Day holiday a ﬁre broke © 2003 by Marcel Dekker, Inc.

out in the Imperial Food Products plant in Hamlet, North Carolina, killing 25 people and hospitalizing 56 people. The plant was producing chicken nuggets and marinated chicken breasts for fast-food and grocery sales. The ﬁre began with a rupture in the hydraulic line powering a conveyor belt that carried chicken parts to the deep-fat fryer. The fryer burst into ﬂame when the hydraulic ﬂuid and its vapor came into contact with the hot oil. What made this tragedy even more terrible was that plant workers were unable to escape. At least two ﬁre doors were padlocked and another was blocked by a delivery truck [3,4]. In the aftermath of the ﬁre, 83 additional violations were discovered. Among these were a sprinkler system which apparently did not work, locked exits, inadequate lighting, and unmarked exits. Imperial Food Products owners have been ﬁned $808,150 for these and other violations by the State of North Carolina Labor Commissioner. Criminal indictments were handed down in March 1992 against two owners and the plant’s manager. Imperial has also closed its other plants and disconnected telephones at its headquarters [5]. This was obviously a tragedy of monumental proportions, especially in a small town. Legally the fault lies with management. They were the ones responsible for operating a safe plant as required by Occupational Safety and Health Administration (OSHA) laws. They failed to do so, and they paid for the failure. Investigation also revealed that some blame must also be placed on the workforce, including several of those who paid with their lives as a result of the accident. Interviews with survivors indicated the doors were routinely locked to prevent workers from stealing chickens [6]. At this point we wish to focus on the concept that safety is everyone’s responsibility. Management is ultimately responsible, but each worker must contribute to assuring that the workplace is safe. How does a company go about assuring the safety of its employees? There are certain points basic to workers safety. These happen to be very similar to those that apply to food safety, plant sanitation, and other operations. They include (1) management commitment to providing a safe workplace; (2) education of management and staff; (3) safe plant design and maintenance; (4) proper equipment design and maintenance; (5) knowledge of and adherence to federal, state, and local safety regulations; (6) evacuation plans with posted warnings and directions; (7) monitoring to assure compliance; (8) maintenance of records of inspections and upkeep; and (9) a commitment by all personnel in a workplace to maintain a safe work environment. Another reason for maintaining a safe work environment, other than being a requirement of OSHA law, is liability. Each time there is an on-the-job injury, the company’s insurance takes care of it. With each injury there is a potential for a rate increase. The insurance industry calls it ‘‘experience modiﬁcation rate.’’ The experience modiﬁcation rate is used to determine one’s insurance premiums. Take, for example, two companies with the same number of employees; one has a bad record with many injuries and may be put into a high risk pool by its insurance company and pay higher premiums. The other company, with a low experience modiﬁcation rate, might pay half or one-third of what the high risk company is paying. It is a huge difference in terms of actual dollars. This money saved could be used to implement a comprehensive safety and health program for the establishment. Employees will be happier working in a safe environment; production may increase and thus proﬁts will rise. Employees might get a year end bonus from the company. Mutual beneﬁts exist for both the company and its employees. © 2003 by Marcel Dekker, Inc.

A. Management Commitment Everything starts from the top. If management is behind something and committed to it, that program has a very good chance of succeeding. B. Education All supervisory staff and workers must be given a basic class in worker safety. This program should include plant safety rules, speciﬁc requirements for speciﬁc work areas, and safety regulations required by federal, state, and local ordinance. Also included should be ﬁrst-aid instructions, what to do in case of a ﬁre or a disaster, and both manager and worker responsibilities for their own safety and for others. C. Safe Plant Design and Maintenance The work environment contributes to a person’s attitude about safety. A plant that is designed so that it is difﬁcult to maintain or get around in will be more prone to problems. This may not be so much of a problem for newly designed plants, but the old ones can be nightmares. There should be easy access through work areas, easily identiﬁable accessible exits with lighted signs, good lighting, ﬂoors and walls that are easily cleanable, ﬂoors that are nonskid, and safety walkways to avoid confrontation with moving carts or other equipment. D. Equipment Design and Maintenance Equipment should be designed and maintained so that it is safe and operates properly. Each unit should be checked regularly. A safety inspection is essential to identify problems and deﬁciencies in the plant. Most items that fail usually show some indicative sign of impending failure. Workers who work with the equipment daily should be trained to recognize such signs, but the company should not depend on employees as primary persons to identify such problem or deﬁciencies. The employer is responsible as required by OSHA laws. E.

Knowledge of Adherence to Federal, State, and Local Safety Regulations

Employees have the right to know about the laws governing their workplace and their industry. It is the management’s responsibility to carry out the requirements of the law. Most of the time these laws are the basis of establishing certain programs in a plant. After establishing a written program, a company must implement such a program to assure compliance with the regulations. A perfectly written program will bring a company no good if it is not implemented to its fullest. Not knowing what is required is no excuse in a court of law. F.

Evacuation Plan and Posting of Appropriate Warning and Directions

Every establishment must have an evacuation plan and must communicate such plan to each employee before they start to work. Regulations also require that a large number of © 2003 by Marcel Dekker, Inc.

operations be marked. Areas where food and toxic materials are stored must be in separate locations and marked with clear signs. Each separate container must also be marked. Danger signs should be posted on equipment. Color or date coding to identify certain processes could also be used for a speciﬁc process. Exits should be marked with signs which can lighted in case of power failure. Handling protocols for substances need to be developed for each job. Job hazard analysis for each job needs to be prepared. Personal protective equipment appropriate for such hazard needs are provided to employees who perform such jobs. G.

Monitoring to Assure Compliance

A safety committee should be established with members from management and employee representatives whose task it is to monitor safety concerns. A periodic inspection is required by OSHA laws to identify deﬁciencies. It is also recommended a company invite an outside third party to inspect the facilities. Inspectors for OSHA provide consultation services free to employers; all they need to do is to invite them for a consultation inspection. If the inspector ﬁnd violations, you will be notiﬁed and be given a reasonable time to correct such deﬁciency. The beauty of it is there will not be penalties assessed by the consultation services as compared to the enforcement division penalties that will be assessed on each inspection, even if it is corrected during an inspection. H.

Maintenance of Records of Inspections and Upkeep

Recordkeeping is essential in any operation, especially in a food plant. Without records, problem solving is hamstrung, performance histories of equipment are unknown, and maintenance and replacement of parts or equipment can be compromised. Records of inspection could also be used to analyze the trends of injury and illness in a workplace and to identify deﬁciencies or the need to retrain employees in certain processes. The Occupational Safety and Health Administration has strict recordkeeping requirements; certain medical records are required to be kept for the duration of employment plus thirty years. I.

Commitment from All Personnel

Safety is everyone’s business. Each line worker is responsible for maintaining a safe work area for oneself and for others. This also includes maintaining a work condition that is not hazardous to oneself or others. Some companies have drug and alcohol testing prior to appointment. If a worker were to come to work intoxicated, he or she would be a menace to the workplace. Worker safety is crucial to operating a food processing plant. A safe workplace could also cut down stress, turnover, and absenteeism. Management can show their commitment to safety by going beyond the laws and trying to anticipate anything that might go wrong. With commitment from both management and workers a safety program can go a long way [7]. X.

CONCLUSION

Safety and sanitation programs are essential elements for a company to survive. A company that cares for its employees and complies with federal, state, and local laws and regulations will be more likely to be proﬁtable than those who have high turnover rates © 2003 by Marcel Dekker, Inc.

and high injury rates. Making safety and sanitation practices a way of life in a company is not easy. After carefully selecting your employees, management should start by being an example to employees and make good habits a norm for the company. With initial and continued retraining, reenforced by rewards and peer coaching, a company surely aims toward success. Employees who work at such an establishment can be proud of themselves as part of this process that produces an exceptional product for consumers. REFERENCES 1. Food and Drug Administration. Accessed at www.fda.gov. 2. LC Forrest Jr. Training for the Hospitality Industry. American Hotel and Motel Associations, 1983. 3. Chronicle Wire Services. Fire, locked doors trap plant’s workers—25 die. San Francisco Chronicle, Sept 4, 1991. 4. Associated Press. At least two exit doors were locked in plant ﬁre. San Francisco Chronicle, Sept 5, 1991. 5. Associated Press. Chicken plant ﬁned in ﬁre that killed 25. San Francisco Chronicle, Dec 31, 1991. 6. SB Garland. What a way to watch out for workers. Business Week, Sept 23, 1991. 7. RF Stier, MM Blumenthal. Safety in the processing plant. Baking and Snack, April, 1992.

© 2003 by Marcel Dekker, Inc.

17 Worker Safety and Types of Food Establishments PEGGY STANFIELD Dietetic Resources, Twin Falls, Idaho, U.S.A.

I.

STANDARD INDUSTRIAL CLASSIFICATION OF FOOD ESTABLISHMENTS

Food and kindred products may be classiﬁed according to the Occupational Safety and Health Administration’s (OSHA) ‘‘Standard Industrial Classiﬁcation Manual’’ (SIC Manual). This manual is revised periodically by supplements. Since the introduction of the Internet, the use of this manual has increased tremendously. In this manual, food and kindred products are placed under major group 20. This major group includes establishments manufacturing or processing foods and beverages for human consumption and certain related products, such as manufactured ice, chewing gum, vegetable and animal fats and oils, and prepared feeds for animals and fowls. Table 1 describes the industrial establishments according to categories of food and kindred products, and the group number for each category is also given. Table 2 describes food establishment categories, operations, and product examples. II. POTENTIAL OCCUPATIONAL HAZARDS IN A FOOD PROCESSING PLANT The potential hazards associated with the manufacturing processes in the nearly 50 subdivisions of food and kindred products are primarily safety hazards (see Table 3). The following safety hazards are generally common to all the processes: 1. Extensive manual handling of feed and in-process materials and of ﬁnished products © 2003 by Marcel Dekker, Inc.

Table 1 Classiﬁcation of Industrial Establishments According to Categories of Food and Kindred Products Group number 201 202 203 204 205 206 207 208 209 a

Establishments of manufacturing or processing Meat products Dairy products Canned and preserved fruits and vegetables Grain mill products Bakery products Sugar and confectionery products Fats and oils Beverages Miscellaneous food preparations and kindred products

a

This group includes canned and cured ﬁsh and seafoods, fresh or frozen packaged ﬁsh and seafood, roasted coffee, manufactured ice, macaroni, spaghetti, vermicelli and noodles, and food preparations not elsewhere classiﬁed. This category includes baking powder, yeast, and other leavening compounds; chocolate and cocoa products, except confectionery, made from purchased materials; peanut butter, packaged tea (including instant); ground spices; potato, corn, and other chips; and vinegar and cider. There are others.

2. 3. 4. 5.

Extensive exposure to slippery ﬂoors and supports Extensive use of sharp implements such as cutting hand tools, saws, and knives Exposures to microorganisms, chemicals, allergens, viruses, molds, and dusts on substances in the feed materials Seasonal operating schedules, reﬂecting time of harvesting that inﬂuence safety training effectiveness

Speciﬁcally, particularly high rates are associated with the meat processing, food preservation, sugar and confectionery, fat and oil recovery, and beverage processes. In general, average rates are associated with the dairy, grain mill, and bakery processes. The high injury and illness rates in the meat processing and fat and oil recovery processes appear to result primarily from hazards associated with cutting and hand tools, slippery ﬂoor conditions, and batch handling. There is little speciﬁc information that explains the elevated rates associated with the food preservation and sugar and confection processes, but the seasonal schedules and temporary, untrained workforces employed to meet harvest requirements are important factors. In the beet and cane sugar industry, contusions and bruises to hands and feet, especially to maintenance workers, are a frequent cause of injury; scalds from hot water are considered to be another important factor. The foremost potential hazards associated with the beverage processes, particularly the bottled and canned soft drink processes, are body strains and sprains arising from the manual handling of the products. Outbreaks of diseases of bacterial origin in meat processing facilities appear to be foremost among the reported non–safety-related potential health problems associated with that industry. Reports of brucellosis and skin sepsis in slaughtering and rendering plants, psittacosis in a turkey processing plant, and antibodies to Escherichia coli enterotoxin in beef and swine meat-packing workers were encountered. Respiratory illness resulting from © 2003 by Marcel Dekker, Inc.

Table 2

Food Establishment Categories, Operations, and Product Examples

Food establishments Packing houses (201)

Dairies and creameries (202)

Canneries and preserving (203)

Grain mills (204)

Bakeries (205)

Operations product examples Slaughtering Dressing Packing Processing Churning Cheesemaking Condensing Freezing Canning Drying Pickling Freezing Flour milling Corn meal Rice milling Wet corn milling Prepared foods Baking ‘‘Dry’’ baking

Sugar reﬁneries and confectioneries (206)

Extracting, concentrating, and crystallizing cane and beet sugar Processing confectioneries

Fat and oil (207)

Extracting vegetable oils and animal oils by pressing, heating and solution Hydrogenating

Beverages (208)

Alcoholic: Brewing Fermenting Distilling Nonalcoholic: Extracting Carbonating Canning Cooking Canning Drying Curing Roasting Ice making

Miscellaneous prepared foods (209)

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Product examples Dressed meat and fowl Meat products Processed meat Fluid milk Butter Cheeses Evaporated milk Ice cream Canned fruit and vegetables Dried products Pickled products Frozen products Wheat, corn, and rye ﬂour Corn products Rice Prepared foods Bread Cookies Crackers Cane and beet sugars Molasses Syrup Candies Chewing gum Vegetable oils Animal and ﬁsh oils Shortening Margarine Edible oils Beer, wine, and spirits

Bottled and canned soft drinks Carbonated drinks Canned and frozen seafoods Roasted coffee Noodles Macaroni Ice

Table 3

Food Processes, Safety Hazards and Controls

Controls process Meat processing (201)

Dairy processes (202)

Food preservation processes (203)

Occupational condition

Control

Handling live, immobile, and slaughtered animals Cutting and use of sharp tools

Strains, contusions

Mechanization, training

Lacerations, loss of body members

Wet ﬂooring, platforms, decks Steam Animal-borne microorganisms Handling churns, homogenizers, plasticizers, evaporators, freezers Handling in-process materials, products Cleaning, cutting, screening, peeling raw fruit and vegetables

Falls, sprains Burns, scalds Brucellosis, dermatitis Lacerations, contusions, etc., from moving machine parts Strains and contusions

Protective clothing, gloves, guards, training Drains, shields Shields, reliefs Inspection Guards, shields, layout, clothing, insulation Mechanization, training

Blanching, cooking, pasteurizing, curing, freezing products Storing, packaging, shipping Grain mill processes (204)

Potential hazard

Operating and servicing breaking rolls, sieves, conveying and elevating equipment, manlifts Handling feed, in-process material products Dust, noise, vibration

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Lacerations, bruises, pinches in operating and maintaining the tools and machines Burns, scalds, extreme temperatures

Guards, shields, clothing, layout, training

Cuts, bruises from packaging machines, sprains Bruises, contusions, pinches, lacerations, falls

Guards, gloves, shields, mechanization Guards, varriers, training

Body strains

Mechanization, training

Respiratory and hearing effects

Ventilation, insulation

Insulation, shields

Bakery processes (205)

Sugar and confectionery processes (206)

Fat and oil recovery processes (207)

Beverages (208)

© 2003 by Marcel Dekker, Inc.

Mixing, kneading, and forming machinery/conveyors Baking ovens Handling in-process materials, products Cleaning, grinding, shredding, and extraction machinery Puriﬁers and chemicals Concentrators, crystallizers Centrifuges, ﬁlters, dryers under operating and maintenance conditions Extracting oil and fat from animal and vegetable processes by steam distillation, mechanical expression, solvent extraction Cleaning, grinding, shredding feeds Puriﬁcation, hydrogenation processing Handling in-process materials Broken glass

Injuries from moving parts

Guards, shields, layout

Burns, hot working environments Strains

Insulation, clothing, air conditioning Mechanization, training

Lacerations, contusions from moving machine parts Lime, sulfur dioxide, chlorine dioxide, formaldehyde Burns, spills, leaks Lacerations, contusions, burns

Guards, protective clothing, layout, ventilation, drains, overﬂows Controls, ventilation

Burns and scalds from steam and liquor leaks, spills; breaks and leaks from presses; vapors and gases from extractors Machine injuries Chemical effects Body straining from lifting Lacerations

Overﬂows, drains Controls, maintenance, insulationsizing Insulation, barriers, layout, controls against overloads, spills, ventilation and monitoring Guards, training Ventilation Increasing mechanization, training Protective clothing, gloves

exposure to polyvinyl chloride pyrolysis fumes is a potential health hazard for meat wrappers. Brucellosis is an acute or subacute infectious disease with variable manifestations. It is characterized by attacks of irregular fever, chills, sweating, and pain in muscles and joints, which may last for months. The disease shows remissions and although relapses are frequent, brucellosis does produce substantial immunity to reinfection. Because it can be confused with almost any febrile episode, diagnosis is very difﬁcult unless blood cultures are positive. The Brucella species that are classically infective for man are found in dairy cattle (Brucellosis abortus), hogs (B. suis), and sheep and goats (B. melitensis). Each of these species may occasionally infect the other animals. Brucellae are distributed throughout the infected animal and may remain viable for 21 days in a refrigerated carcass. The tissues, blood, placenta and fetus, milk, and urine may be infectious. They may survive the curing of ham, but are killed by smoking, cooking, and pasteurization. Brucellae may invade through the eye, nasopharynx, genital tract, and gut, but unbroken skin is resistant. Contact with swine is the probable source of infection. An outbreak of psittacosis among workers in a turkey processing plant had been reported. Cases occurred in employees working in the kill-and-pick, evisceration, and packaging departments, and inhalation of infectious sprays of poultry blood and other tissues was considered to be the primary route of infection. The results of the investigation suggested, however, that workers having both frequent contact with turkey tissues and skin injuries were more likely to be infected than other processing workers. Psittacosis is a disease of bacterial origin (Chlamydia psittaci), which usually takes the form of a pneumonia accompanied by fever, chills, headaches, body aches, cough, and often splenomegaly. Respiratory tract illness has been reported in meat wrappers exposed to polyvinyl chloride (PVC) pyrolysis fumes while working with hot wire cutting machines. From the data available, it appears that the major emissions from the meat wrapping ﬁlm are di-2ethylhexyladipate and hydrogen chloride. Meat wrapping, however, is usually performed in the meat departments of retail supermarkets. Respiratory distress has also been reported in some meat cutters following exposure to heat-activated price labels; emissions from heated price labels have recently been found to include phthalate anhydride, 2,5-di-tertamylquinone, and dicyclohexyl phthalate. The rates for injury and illness in the industry’s processes are considerably above the average for U.S. manufacturing and one of the highest in all manufacturing. Design features that may reduce employee exposure to hazards basically involve factors that ensure steady and uninterrupted equipment operation, such as sizing, strength, capacity corrosion, and wear-resistance properties. Overloading, spills breakdowns, and failures are major causes of potentially hazardous exposures. Engineering controls should also provide adequate space for easy and safety access to the equipment by production and maintenance workers and means for sensitive, reliable, and accurate monitoring of process conditions. In addition to those basic design controls, engineering controls apply to speciﬁc working conditions. Adequate and reliable ventilating, scrubbing, and monitoring systems should be provided to ensure good air in working areas. Vents for storage tanks and closed areas may also be required, as well as comprehensive safety guarding systems for cutting tools and moving machine parts, and proper electrical grounding. Insulating and isolating barriers for excessive temperature, noise, or vibration may be appropriate in certain instances. Maintenance tends to increase the potential for hazardous exposures because of the unusual conditions that may develop and the special procedures that may be involved. Table 3 describes food processes, safety hazards, and controls.

© 2003 by Marcel Dekker, Inc.

III. AN EXAMPLE OF WORKER SAFETY IN A BAKERY ESTABLISHMENT A. Identiﬁcation Industry: bakery products. Subgroup: bread, cake, and related products; cookies and crackers. Standard Industrial Classiﬁcation: 2051, 2052. B. Process Description Bakery goods include bread, cakes, pies, cookies, rolls, crackers, and pastries. Ingredients consisting of ﬂour, baking powder, sugar, salt, yeast, milk, eggs, cream, butter, lard shortening, extracts, jellies, syrups, nuts, artiﬁcial coloring, and dried or fresh fruits are blended in a vertical or horizontal mixer after being brought from storage, measured, weighed, sifted, and mixed. After mixing, the dough is raised, divided, formed, and proofed. Fruit or ﬂavored ﬁllings are cooked and poured into dough shells. The ﬁnal product is then baked in electric or gas-ﬁred ovens, processed, wrapped, and shipped. Loaves of bread are also sliced and wrapped. Figure 1 presents a simple outline of the process ﬂow in this category of food establishments. C. Injury Type and Sources In bakery products, most of the injured employees are struck by or struck against some object; fall or slip; or are caught in, under, or between objects. The injuries most commonly encountered are dislocations, sprains, and strains and often involve machines and working surfaces as sources of injury. D. Inspection Analysis When a company ofﬁcer inspects the bakery establishment for safety concerns, he or she should do the following analysis. The inspection should begin in the receiving and storage

Figure 1 Process ﬂow for bread, cakes, and related products. © 2003 by Marcel Dekker, Inc.

Table 4 OSHA Hazards Analysis Activities or equipment

Location

Mechanical power transmission apparatus

Throughout plant

Housekeeping Point of operation

Throughout plant Throughout plant

Electrical connections Ovens and open fat kettles

Throughout plant Throughout plant

Broken chain links and pulleys causing mixing bowls to fall on employees Back strains and pulled muscles

Cranes and hoists

Mixing areas

Lifting

Explosion or ﬁre

Combustible dusts

Mixing and baking areas Storage

Major hazards Amputation and mangled limbs from contact with gears, shafts, pulleys, belts, chains, and sprockets Slipping, tripping, and falling hazards Amputation and mangled limbs from nip points and sharp blades Electrocution from inadequate grounding Burns from hot pipes and hot fat splashes. Inhalation of carbon monoxide Other hazards

areas where bins must be checked for safety ladders of nonsplintering material. Any OSHA Class II hazardous locations must have approved electrical ﬁxtures. Mixers should then be checked for interlocks, along with agitator guards, size of openings, and cranes for moving bowls over 80 lbs. Bread rollers must have in-running rollers guarded, and the slicing machine must have a device to push the last loaf of bread through and be interlocked. Employees must be checked for personal protective equipment at hot fat kettles. Machines must be grounded and have power transmission guarded throughout. Any hot water or steam pipe must be guarded, especially in mixing and oven areas. Any conveyor passing over an aisle must have a lower guard to protect employees passing underneath baking machinery. Dividers, dough breaks, biscuit and cracker equipment, sugar and spice pulverizers, cheese and fruit cutters, and dough sheeters shall have guards to protect nip points and points of operation. Aisles must be clear of all tripping and slipping hazards, particularly at open fat kettles. High noise areas must be surveyed or referred to an industrial hygienist. E.

Occupational Safety and Health Administration Hazards Analysis

Table 4 presents the types of hazards, their causes, and their occurrence in the bakery processing plant. F.

Other Pertinent Information

An Industrial hygienist referral must be made for ﬂour dust, which can cause rhinitis, buccopharyngeal disorders, bronchial asthma, and eye diseases. There is a high incidence of pulmonary tuberculosis among bakers. ACKNOWLEDGMENT Most data in this chapter have been modiﬁed with permission from documents prepared by Science Technology System, West Sacramento, California.

© 2003 by Marcel Dekker, Inc.

18 Rodent Pest Management ROBERT M. CORRIGAN RMC Pest Management Consulting, Richmond, Indiana, U.S.A.

I.

INTRODUCTION

Commensal mice and rats are among the most signiﬁcant of all pests of the food and food-warehousing industry. Rodents attack foods or food ingredients directly, rendering such foods contaminated and lost. The presence of feces, hairs, or any other parts of rodents in, around, or on food, food preparation surfaces, or food containers is also considered adulteration. From a legal aspect, the presence of rodents or rodent evidence is a violation of Section 402(a) of the Food, Drug, and Cosmetic Act. Consequently, some inspection services (e.g., American Institute of Baking, Manhattan, KS) have guidelines that may call for an immediate unsatisfactory audit should even one decomposing rodent be found inside a trap or bait station [1]. As a result of these strict guidelines, most of the service time (and thus money) allocated in the food and warehouse industry toward the annual pest management programs and budgets is spent on purchasing rodent control tools and on contracted service time required for maintaining rodent control devices [2]. Rodent prevention programs and infestation reduction efforts for food plants should be designed with a strong emphasis on the integrated pest management (IPM) approach. Well-designed and implemented IPM programs are especially critical to ensure long-term, cost-effective food safety.

II. RODENT BIOLOGY OVERVIEW An in-depth discussion of the biology and behavior of the commensal rodents is not necessary for the purposes of this book. The following discussion presents only an overview © 2003 by Marcel Dekker, Inc.

of rodent biology as it applies to food plant rodent pest management. Readers interested in additional information on rodent biology and behavior should consult the appropriate references [2–4] at the end of the chapter. The three principal rodent pests in the United States are (1) the house mouse, Mus domesticus, or Mus musculus (both names are used for the same species); (2) the Norway rat, Rattus norvegicus; and (3) the roof or black rat, Rattus rattus. A brief overview of the pertinent aspects of the biology and behavior of each of these rodents as they relate to routine food plant operations is given in Table 1. The house mouse and Norway rat are found in all of the contiguous 50 states, although the Norway rat is absent from some relatively large geographic areas of the West. The roof rat occupies the coastal areas of Washington, Oregon, and California, as well as large areas along the Gulf and Atlantic coast from Texas to Maryland. Roof rats are not established in the midwestern states, although they are delivered there in supplies and vehicles from time to time. In the states where roof rats do occur, rarely are they found more than 100 miles inland. By far, the house mouse is the primary food industry rodent pest because of its wide distribution, its small size (enabling it to remain undetected inside many objects and supplies), and its abundance in outdoor areas surrounding commercial and residential buildings. Most people are familiar with the ubiquitous house mouse (Fig. 1). It is a nondescript, brownish to grayish rodent with relatively large ears and small eyes. The adults weigh from 0.5–1.0 oz (15–30 g). Newly weaned juveniles may weigh only about 10 g (mousetraps suitable for their small size are required for effective control). Adult mice measure between 5.5–7.5 in. (14–19 cm) long, including the 3- to 4-in. (8- to 10-cm) tail. The house mouse is easily distinguished from the ‘‘ﬁeld mouse’’ (Peromyscus spp.). Peromyscus mice are characterized by a bright white pelage on the belly, feet, and the underside of their furry tails. The Norway rat is a large, robust rodent; however, its size is often exaggerated by people who encounter this rat in a dark corner of a warehouse or alleyway (e.g., ‘‘it was as big as an alley cat’’). Most adults measure about 16 in. (41 cm) in total length from the nose to the end of the tail and weigh about 12 oz (340 g). Some rats achieve heavier weights of 16 oz (453 g) or slightly more. The length of the tail is shorter than the body. The typical pelage color is grayish brown, but it may vary from a pure gray to a blackish or reddish brown. Because of individual variations in the fur color, rats should not be identiﬁed by color alone. The roof rat (or black rat) is considerably smaller than the Norway rat, weighing about 8 oz (226 g) and measuring about 16 in. (41 cm) in total length from its nose to the end of its tail. Although this is the same total length as the Norway rat, the roof rat’s tail is longer than the body, a key identifying characteristic. In general appearance, the roof rat is sleeker than the Norway rat. Roof rats are not always black in color. They may be wholly black or brown-backed with the belly varying from gray to cream-colored or white. Weed seeds, nuts, grains, insects, and various small mammals, birds and aquatic animals (for rodents living near water) comprise the ‘‘natural’’ foods of rodents living outside in their natural habitats. Around human dwellings and commercial structures, rodents become opportunistic foragers, adapting to many different types of foods depending on availability. Rats and mice will consume cereal grains, garbage, insects, meat, fruits and vegetables, and even manure from pets in suburban backyards. © 2003 by Marcel Dekker, Inc.

Table 1

Rodent

Overview of Biology and Behavior of Rodents as Applicable to Food Plant and Warehouse Infestations Pups per Annual Daily food litter litters a consumption

Daily fecal pellets

House mouse 5–7

6–8

2–4 g

Norway rat

8–12

4–7

15–35 g

25–40

Roof rat

8–12

4–7

10–25 g

25–40

a b

Daily foraging range b

40–100 Within pallets, hollow walls, suspended 1–10 m ceilings, voids of large equipment, and among clutter

Assuming a life span of one year. Once established indoors or on the exterior periphery.

© 2003 by Marcel Dekker, Inc.

Typical harborage inside or around food plants

Exterior and interior burrows, beneath slabs, within hollow walls and ceilings Aerial rafters and roof areas; tree crowns adjacent to roof areas; silo tops in structural voids

Important notes

Populations build up quickly out of sight and in hard to reach areas if food is easily available. Mice established within pallets are not highly impacted by perimeter wall traps. 5–30 m Some rats inside food plants and warehouses exhibit extreme caution and do not interact traps or bait stations. 5–100 m Some adults may be elusive, responding only to fruits, nuts, and vegetable types of foods. Inspections must be from aerial sight areas.

Figure 1

The house mouse (Mus domesticus) is the most important rodent pest of the food in-

dustry.

House mice are sporadic feeders, nibbling bits of food, and making as many as 20– 30 short visits to food per night, eating only tiny amounts during each visit. Most adult mice consume about 3–4 g of food per night. Norway rats tend to get their daily food at one or two locations, consuming up to 30 g per night. Roof rats are somewhat of a hybrid in feeding behavior between the mouse and the rat, feeding in smaller amounts at several locations and consuming up to 20 g of food per night. Rats require 0.5–1.0 oz (15–30 mL) of water daily (unless feeding on moist or succulent foods). House mice can survive for long periods without free water [5]. Rodents have impressive capacities for reproduction, especially if they become established inside commercial facilities that provide constant warmth, easily obtainable food, and protection from dangers and disturbance among clutter and junk piles. A food storage warehouse, for example, that does not have a strict sanitation program, one where pallets of food are pushed up against walls, allowing for hidden harborages—such a warehouse is an ideal environment for a rodent population explosion. For example, in a single year a female mouse produces about 6–8 litters, each litter averaging 5–7 pups. The pups are born 19–21 days after mating, and they can reach reproductive maturity in 6–10 weeks. In one study [6] of wild mice in outdoor pens simulating a small number of mice exposed to readily available food and harborage, the new mouse colony of 28 mice grew to 2000 mice in only 8 months. With these impressive reproductive capabilities in mind, it should be obvious that no food manufacturer can afford to be lax on any part of a rodent management program. Providing they live for a full year and have ready access to food and water, female Norway and roof rats typically produce about 4–7 litters, averaging 8–12 pups, following a gestation period of about 3 weeks. Rats reach reproductive maturity between 8–12 weeks. © 2003 by Marcel Dekker, Inc.

Both rats and mice have natural life spans ranging from 5 to 12 months. Commensal rodents living in natural habitats (not in manmade structures) typically live only a few months, although the dominant individuals may live for up to 1.5 years. Inside heated structures, the longevity of the rodents depends on resource abundance and availability, space, and rodent population densities. Thus, much of the success of rodent population growth inside and around buildings depends on people. III. RODENT IPM PROGRAMS The components of a rodent integrated pest management program for food plants include (1) exclusion, (2) sanitation, and (3) rodent elimination programs via the ‘‘three lines of defense’’ system. It cannot be overstated that exclusion and sanitation efforts must comprise the main thrust of a food plant’s rodent control program. Being mammals, rodents require much more food, shelter, and water than insects. Thus, rodents can be dramatically affected by sanitation and pest exclusion efforts that reduce their basic survival elements, and thus their potential to proliferate. In other words, sanitation is rodent control. The principles of sanitary practice and hygienic design, including features that address pest exclusion, are covered elsewhere in this book. Those chapters should be carefully reviewed to ensure a thorough understanding of the role these components play in pest management operations. Still, a brief overview of exclusion and sanitation as they speciﬁcally apply to rodent threats and pressures associated with food plant environments is also presented here. A. Rodent Exclusion Rodents living outdoors embark on nightly explorations and occasional dispersal journeys. Either by chance or by following air currents carrying food odors, some of these run into the walls of residential and commercial buildings. During these forays, most rodents tend to investigate any nooks and crannies they encounter. However, those openings from which currents of warm air or food odors emanate are particularly prone to rodent invasion. Upon discovering a useful opening, rodents usually mark it with urine or fecal pellets. Because rodent excrement often contains pheromones [5,7], such marked areas may attract other rodents to these actual or potential points of entry. It is obvious, then, that a properly rodent-proofed building will admit fewer rodents than a building with unprotected points of entry. Because mice require only a 0.25-in. (6-mm) gap to gain entry, even openings appearing insigniﬁcant (to us) are important and should be sealed. Exterior walls facing or close to open ﬁelds, wooded areas, and rail lines often are the most prone to invasion. Several of the most rodent-vulnerable entry points are given here: rail doors (where rail cars enter a building); rail pits; ramped bay doors; shipping and receiving docks and dock levelers; doors with improper threshold closures; open man doors; unsealed utility lines entering the plant; and the various unrepaired structural faults and openings into the plant. Rodents readily climb various brick and stone walls, conduit lines, building corners, and drainage gutters to gain access to roof areas. They then enter the plant from any of the various roof utility systems. All utility components located on roofs, such as ventilation fans and air-handling systems, must be rodent-proofed. This is especially important in those regions of the country where the roof rat is prevalent. © 2003 by Marcel Dekker, Inc.

Even with thorough exclusion efforts, some rodents will inevitably gain entry to most food plants over the course of a year. Nevertheless, the difference between 10 mice or 75 mice entering a facility each year is dependent upon (1) the quality and thoroughness of the facility’s rodent prooﬁng, (2) the general sanitation program of the plant, and (3) the attitude and cooperation of plant employees in keeping the doors closed as much as operationally possible. Detailed information on pest prooﬁng of buildings is readily available [2,8–10]. B.

Sanitation

1. Exterior Areas Although some rodents may get into a food plant or warehouse as stowaways on pallets or in supplies, most interior rodent infestations originate from habitats immediately adjacent or close to the building exterior. It is for this reason that the plant exterior must be held to the highest sanitation standards possible. Allowing weeds and landscaped areas to grow unmanaged can result in substantial rodent populations ﬂourishing at the threshold of the premises. Similarly, allowing old equipment, conduit lines, food transfer shafts, discarded screw conveyors, and similar items to accumulate on the ground adjacent to exterior walls is tantamount to installing ‘‘rodent magnets’’ to the building periphery. Rodents are behaviorally programmed to investigate the circular shadow openings of an empty conduit pipe lying on the ground in the same manner that they are drawn to investigate the opening of a hole in a tree trunk, a ground burrow, or the entryway of a curiosity mouse trap. Any fermenting food residues on a plant’s periphery or rooftop will attract rodents that are opportunistically foraging about at night. All exterior food spills and residues must be cleaned up as quickly as possible, and any large odiferous spills must be removed without delay. Exterior out-of-sight and hard-to-reach areas such as dock leveler pits, dumpster voids, and bone yards are especially important to keep clean. Fines from roof vent blowout areas are also critical. Rodents will scale exterior walls when following the odors of fermenting ﬁnes lying about on roofs. 2. Interior Areas For interior areas, the maintenance of a clean and unobstructed continuous sanitation line (also called an inspection aisle) along the entire interior side of the plant’s or warehouse’s exterior walls is one of the most important aspects of sanitation relative to rodent pest management [11,12]. Without this aisle, rodents can easily remain undetected and cause signiﬁcant contamination and destruction of product. Extant regulations do not stipulate any speciﬁc minimum width for the inspection aisle. However, as a practical matter when implementing good manufacturing practices (GMPs), the aisle should be sufﬁciently wide to allow easy inspection and cleaning by plant personnel and to facilitate trap placement by pest management professionals (PMPs) (see below). Most plants allocate about 18–24 in. (46–61 cm) of space for the inspection aisle. The aisle is painted white to facilitate easy sighting of black dirt, rodent droppings, and insects. Some food plants also install various types of heavy-duty ﬂanges or poles to discourage forklift operators from encroaching upon the line. In warehouses, adequate space should also be maintained between rows of stacked product to facilitate inspections and reduce incidents of breakage and spillage. This is © 2003 by Marcel Dekker, Inc.

especially important in warehouses that store seed, dry bagged pet foods and other foods in paper bags stacked on wooden pallets. In these situations, mice commonly take up residence and carry out their feeding and propagation activities without any need to emerge from the stacked product. These ‘‘pallet mice’’ are for the most part unaffected by the standard perimeter baits and trapping programs [2]. By means of painted aisle lines on the warehouse ﬂoor, order is maintained, spillage is reduced, and the overall environment is made less attractive to rodents. C. The Three Lines of Defense 1. Background In addition to implementing sanitation and rodent prooﬁng efforts, the use of rodent baits and traps also plays a major preventive and remedial role in a food plant rodent IPM program. Baits and traps are typically utilized in a ‘‘perimeter defense’’ program consisting of three (sometimes two) lines of defense. This program involves surrounding the plant’s (1) property line (if one exists); (2) exterior walls, and (3) interior walls with bait and/ or trap stations (Fig. 2). The goal of this program is to protect the plant by killing or capturing any rodents foraging about outside on the property (that could potentially enter the plant) or to capture any mice that might enter the premises through doors or openings or arrive within incoming shipments. The most common strategy is to place mousetraps at intervals along the inside of the exterior walls. Rat trap stations may also be placed in areas and at intervals dictated by the need. Interestingly, the perimeter defense program was not developed as a result of research or any type of quantitative ﬁeld trails. Rather this program appears to have evolved from the recommendations of government and other publications on rodent control during the 1940s and 1950s [13–15]. These publications provided general recommendations for placement locations and spacing of rodent traps and bait containers for the control of mouse and rat infestations, based on the reported foraging ranges (‘‘territories’’) of rodents. These recommendations were broadly adopted for grain storage and warehousing facilities [16,17]. Eventually, they were adapted for the food industry and the ‘‘standard perimeter defense model,’’ based on the early recommendations, remains in place to this day [1,18]. Recently, the general applicability of the three-line defense model to all situations has been challenged. For example, the numbers of bait or trap stations as recommended in the early publications may be appropriate for those facilities subject to intense and continuous rodent activity. However, for facilities located in areas subject to only low rodent pressure and which are designed and constructed in a manner that discourages rodent intrusion, the ‘‘standard’’ perimeter defense program may be excessive and unnecessarily expensive. This is especially true for some of the modern ‘‘superfacilities’’ that may be several million square feet in size. Evidence that this challenge is justiﬁed may be found in the records of several food plants and warehouses coast to coast that show the results of exterior and interior rodent activity and capture monitoring over the past 10–15 years. Some of these facilities have been able to consistently demonstrate that only a small percentage of their bait stations and/or traps receive monthly activity. The managers of these plants may seek the advice of pest management consultants on ways to tailor their rodent management programs to © 2003 by Marcel Dekker, Inc.

Figure 2 A general schematic of a rodent protection program for a food plant warehouse using the three lines of defense system: (1) along any property fence rows, bait or trap stations are installed at 50- to 100-ft intervals; (2) along the building’s periphery exterior wall, bait or trap stations are installed at 30- to 50-ft intervals; (3) inside, mousetraps (any of various models) are typically installed at 20- to 40-ft intervals along the entire wall perimeter. A shorter spacing on any of the devices is determined by the amount of protection desired or by the speciﬁc situation and operations of the facility. In areas where rodent pressure may be high, or for product areas needing additional protection, more stations can be added accordingly. Illustration not drawn to scale.

match the demonstrated levels of rodent pressure without compromising product quality. This careful approach to rodent management, based on documented experience, ﬁts in well with a basic premise of IPM: use pesticides only when need has been demonstrated via monitoring and/or documented pest activity. On the other hand, some facilities are subject to higher than average rodent activity, at least in some areas around the plant. Accordingly, for these plants an increase in the number of stations or interior traps (over and above the recommended standard) is called for to better protect the plant and further decrease the number of rodents in the exterior areas. Or such plants might do well to further customize their program by increasing the number of units along those walls and in those areas subject to greater activity, while maintaining the standard spacing and quantities for all other parts of the plant [2]. © 2003 by Marcel Dekker, Inc.

Perhaps the time has come to formally research the one-size-ﬁts-all perimeter defense model. Some plants may easily maintain outstanding food safety by setting out relatively fewer bait stations (and thus decreasing pesticide use) and by implementing strategic placement of rodent control devices based on reliable data. For other plants, more rodent control devices may be required in excess of the standard recommendations. Obviously, these critical decisions cannot be reliably made without accurate rodent capture and bait station activity records. Without any data to justify a speciﬁc type of program, it makes sense to err on the side of safety and utilize the standard perimeter defense program, as illustrated in Fig. 2. 2. New Technologies Prior to a discussion of the practical implementation of rodent pest management programs, an overview of the new technologies and techniques that have emerged over the past decade will provide a sound basis for understanding the management programs described in this chapter. a. Rodenticide Baits. Rodenticide baits and their active ingredients have changed relatively little over the past decade, with only one new active ingredient, difethialone (Generation ), coming on line. Although similar in mode of action to all of the current secondgeneration anticoagulants, difethialone is formulated at 25 ppm, half the concentration of other anticoagulant food baits. The nonanticoagulant rodenticide bromethalin has been reformulated and remarketed (as Fastrac and Top Gun ) by two manufacturers since its introduction in the early 1980s. Because bromethalin produces death in rodents relatively quickly (1–3 days) compared to anticoagulants (5–7 days), it is obviously an attractive agent for use in food plant environments. Note, however, that each block of bromethalin bait is approximately twice the cost of an anticoagulant bait. b. Nontoxic Monitoring Food Baits. Nontoxic monitoring food baits have recently made an appearance in the pest management industry. These blocks are simply the food block bait carriers as used in the standard rodenticidal bait blocks, but they do not contain any active ingredient. Monitoring food baits are used in exterior areas (as per discussion below) to monitor for the presence of rodents prior to the installation of any rodenticide. Should the monitoring blocks indicate feeding by rodents, a rodenticide block is then installed into the active station. In this way, true IPM is being conducted, that is, pesticides are not employed unless there is a pest present to justify their use. For food plants and warehouses with only light rodent pressure, the use of bait monitors offers a progressive path toward implementing the IPM concept. Currently, only one brand of nontoxic monitoring block is available (Detex by Bell Laboratories). Zeneca (now Syngenta) marketed Census in 1996, but discontinued the product due to a lack of interest by the pest management and food industries. c. Bait Stations. Bait stations (boxes, containers) have appeared in new designs and construction materials over the past decade. Several different kinds of bait stations are now available to the food industry for exterior baiting programs. For the most part, the various designs impact the serviceability of the stations more than adding to the actual efﬁcacy of controlling rats and mice feeding from the stations. In other words, most foraging wild rodents are apt to explore a hole in their pathway regardless of the shape, color, or construction materials of the box containing the hole. © 2003 by Marcel Dekker, Inc.

Still, stations that are easy to inspect, service, clean, and repair and that effectively present baits while minimizing hazards to nontargets (organisms inadvertently impacted by pesticides) and the environment are certainly important to the food industry overall. Some new bait stations offer unique designs for easy opening and bait change-outs. Others offer see-through covers. Some brands provide maximal tamper resistance via the use of heavy-duty metal construction materials. d. Trap Stations. Recently there has been an interest in the use of exterior bait stations as ‘‘trap stations,’’ that is, installing either mouse- or rat traps into bait stations in lieu of rodenticidal baits. The use of traps instead of baits offers a food plant two advantages: it reduces the amount of pesticide used at the food plant and the offending rodent and its threat to food safety are both immediately eliminated (contrast this with the anticoagulantpoisoned mouse that continues to deposit feces and urine for up to a week while the rodenticide takes effect). Several bait station manufactures have recently modiﬁed their station designs to accommodate either the use of baits or the installation of mouse- or rat traps. e. Rodent Snap Traps. New designs in rodent snap traps have also occurred over the past few years. The most common new mousetrap design is a ‘‘clam-style’’ trap, now manufactured by a few of the leading trap manufacturers (e.g., Woodstream, Victor, and Bell Laboratories). Clam-style traps offer ease of setting by simply pinching the back of the trap with one hand. The captured mouse is emptied from the trap in the same fashion, with no need to touch the mouse. Clam-style mousetraps can be installed inside various bait stations and used in lieu of baits when carcass recovery is of paramount importance. The Kness Manufacturing Company (makers of the well-known Ketch-All curiosity trap) produces the Snap-E trap that can be set with one hand. Here, too, the trap can be emptied without touching the dead rodent. Snap-E traps are available for both rats and mice. f. Multiple-Catch Mousetraps. Several new variations on multiple-catch mousetraps (MCTs) have taken place over the past few years. The most notable changes are that the majority of the metal versions are also now being offered in heavy-duty plastic and in slimmed-down sizes. The substitution of plastic in place of the thin sheet metal for the trap body is welcomed by many professionals who have to service curiosity traps on a large scale. The metal traps are prone to warping and rusting, which render the traps difﬁcult, and thus time consuming, to service. The plastic traps are not only easier to service, they are easier to clean and can also withstand the occasional exposure to water (from ﬂoor cleaning operations, discharge operations, etc.) without any adverse effects on the traps. Another signiﬁcant update in the use of multiple-catch traps inside food plants and warehouses is the practice of inserting inexpensive cardboard glue traps into the holding chambers of the traps. These ‘‘glue board inserts’’ provide several advantages to a food plant. First, they furnish valuable insect monitoring feedback (as insects readily crawl into these traps in their travels along the ﬂoor). Second, they eliminate the need for an inspector to carefully inspect the trap with a ﬂashlight before opening the trap to thoroughly service it. Third, the glue board inserts eliminate the extra time needed to deal with live mice caught in the trap at the time of inspection. And, fourth, because the rodents and insects are captured and contained on the glue board, the hairs, feces, urine, insect fragments, etc. are no longer a contamination threat to a food production facility. For the extra small © 2003 by Marcel Dekker, Inc.

cost of adding the glue inserts to MCTs, a food plant can save signiﬁcant amount of time and provide a good deal of extra protection. g. Battery-Powered Electrocution Traps. Rodent traps are now available that use ordinary batteries for high voltage/low amperage electrocution traps. Some models are available with sensors that provide remote monitoring capability to count trap interactions and electronically record them at a central site. Such a setup would be useful inside a warehouse, for example. However, each trap can only capture one rodent at a time and must then be reset. Some rodents are capable of detecting or escaping the electric shock and avoid the trap completely, especially if they have experienced a prior shock. Electrocution traps are relatively expensive (at least 60 times more for rats and 150 times more for mice) compared to a standard snap trap. h. Electronic Monitoring Devices. As of 2001, several companies are experimenting with electronic monitoring devices (EMDs) for detecting rodent activity in and around rodent MCTs and/or exterior bait stations. Such devices can send a warning to a central site within a food plant, prompting action to be focused on a speciﬁc trap. Providing the EMDs prove to be reliable under all ﬁeld conditions and record only rodent activity, then they may be able to save many hours (and thus many dollars) associated with the manual labor of weekly and monthly inspections of multiple-catch mousetraps and exterior bait stations. i. Bar Coding/Scanning Technology. Several food plants and pest professionals have been using bar coding and ﬁeld scanning equipment over the past 5 years to service bait stations, indoor mousetraps, insect light traps, and stored-product pest pheromone traps. Scanning technology can assist in efﬁciently capturing, compiling, and retrieving data from each unit of all pest control equipment at a plant site. j. Electronic Rodent Repellers. As of 2001, no breakthroughs have been made in the technology of the electronic machines (e.g., ultrasonic, electromagnetic) that supposedly deter rodents from entering buildings. See discussions below for additional details and references that address these electronic devices. 3. Defense Lines 1 and 2 The ﬁrst line of defense is comprised of rodenticide bait (or trap) stations along the outside perimeter of the property line or fence line (if one exists). The second line of defense employs bait or trap stations around the outside foundation wall of a building. a. Rodenticide Baits. Rodenticides are pesticides designed to kill rodents. Four different types of rodenticide formulations (food baits, liquid baits, tracking powders, and fumigants) are available in the pest management industry. However, food baits are the primary formulation used in the food industry. Food bait rodenticides are available in several different formulations: (1) pellets, (2) ground cereal meals, (3) extruded paraﬁnized blocks (called bait blocks), and (4) seeds. Each of these formulations is available either in bulk quantities or packaged into various types of handy mini packs and place packs (as described below). Some examples of rodenticide active ingredients and trade names commonly used in the food industry are listed in Table 2. © 2003 by Marcel Dekker, Inc.

Table 2

Examples of Professional-Level Rodenticide Baits

Active ingredient and concentration Brodifacoum (0.005%)

Examples of trade names 

Manufacturer

Final Talon Contrac Maki Generation

Bell Laboratories Syngenta Bell Laboratories Lipha Tech Lipha Tech

Cholecalciferol (0.075%)

AC 50 Ditrac Quintox

J. T. Eatons Bell Laboratories Bell Laboratories

Bromethalin (acute, nonanticoagulant) (0.01%)

Fastrac Top Gun

Bell Laboratories J. T. Eatons

Bromadiolone (0.005%) Difethialone (0.025%) Diphacinone (0.005%)

Formulations available for exterior uses Blocks, pellets, packet style Blocks, pellets, packet style Blocks, pellets, packet style Blocks, pellets, packet style Seeds, pellets, packet style Blocks, pellets, packet style

Notes: Products listed alphabetically. No endorsement of any product is implied or intended. Labels should be checked to ensure product is registered for use in speciﬁc environments.

Rodenticidal baits used for exterior baiting programs around food plants are often exposed to moisture from rain and snow or to wet or dirty rodents or other small mammals and birds visiting the bait stations. Bait blocks are the most widely used formulation for exterior rodent control programs because they provide excellent resistance to the elements while remaining highly attractive to rodents. Bait blocks will melt down when temperatures inside the bait containers exceed 100°F (37°C) for several hours (a common event in many regions during hot weather). Some bait brands will also swell up and disintegrate if exposed directly to water (sitting in puddles on the station ﬂoor, for example). More importantly, block baits can be secured (via rods) inside bait stations, providing several advantages for exterior baiting programs [19]. The securement of the blocks helps protect and preserve them from the elements such as the wet ﬂoor of a bait station following rain or melting snow or from the wet bodies of animals visiting the stations. Because the secured blocks are also elevated off the ﬂoor, they are less susceptible to damage from slugs, grasshoppers, crickets, roaches, and other chewing insects that destroy exterior rodent baits. Rodents cannot move or kick secured block baits into the entry ways of the station where they are more accessible to reaching hands or paws of nontarget mammals or beaks of birds. And secured blocks virtually eliminate the potential of rodents carrying the bait out of the station (defeating the entire effort in using a tamper-resistant bait station in the ﬁrst place) (Fig. 3). Because of these advantages, the practice of securing bait blocks is now standard in food plant rodent control programs, exceeding even the tamper-resistant criteria of the Environmental Protection Agency (EPA). Packet-style baits (often referred to as ‘‘toss packs,’’ ‘‘throw packs,’’ and ‘‘place packs’’), sometimes also placed inside bait stations deployed outdoors, have some disadvantages. The rodents may not bother to gnaw through the packaging to get at the bait. Nor do packet-style baits provide long-term protection from wetness once a rodent has torn the packet open. Furthermore, unless secured, rodents can drag bait packets out of the station and spill the bait on the ground. Such an event both makes the bait available to nontarget animals (mammals and birds) and less available to other rodents. © 2003 by Marcel Dekker, Inc.

Figure 3 Exterior bait stations typically comprise the ﬁrst line of defense along property fence rows of food plants and warehouses. Block baits are secured on rods to prevent baits from being carried out of the stations by rodents and to prevent the bait being shaken out when the stations are lifted. Secured blocks also help baits remain dry and fresh, thus maximizing bait longevity.

But in cases of extreme wetness or excessive heat that melts the parafﬁn blocks (and where exterior traps are also not the appropriate choice), secured packet baits may be the most appropriate bait formulation. Packet baits can be secured inside stations by hanging the packet from the top end of one of the station’s interior dividing walls using paper binder clamps (the pinch-style clips used to hold stacks of paper together). Some plant PMPs use the packet style baits for only the months of intense heat or wetness and then reinstall bait blocks for the rest of the year. b. Bait Stations. Rodenticide baits around food plants must be placed inside protective containers, called bait stations. For food plant exterior baiting programs (or any incidental and temporary interior baiting program), all bait stations should be tamper-resistant models. Even if it is known that the public or wildlife or pets will not have access to the stations, tamper-resistant bait stations provide better protection to the bait than non–tamper-resistant stations. Most tamper-resistant bait stations are made of either metal or high-impact, heavyduty plastic (Table 3). Bait stations come in sizes for mice (small) and rats (large). For all exterior baiting programs, only the rat-size bait stations are employed as they obviously allow for both rat and mouse entry. The smaller mouse stations are occasionally used for customized, indoor mouse control programs. To be considered tamper resistant according to the EPA requirements, exterior bait stations must be secured to the ground or to a heavy object, a wall or a fence. While there are many ways to do this, a convenient, effective technique is to attach the station to concrete ‘‘patio stepping stone’’ [19]. But take care to use an appropriately sized stone. © 2003 by Marcel Dekker, Inc.

Table 3 Examples of Tamper-Resistant Exterior Bait/Trap Stations a

Brand name Aegis Rodenticide Bait Station Checkpoint Duble-Truble Vertical Station J. T. Eatons Model 903 J. T. Eatons (metal) Protecta Protecta Low-Proﬁle (LP) Rat Cafeteria b bait or MCT station

Manufacturer Aegis, Lipha Tech Ecolabs Corp. (proprietary station) J. T. Eatons J. T. Eatons Bell Laboratories Bell Laboratories Solvit Corp.

Bait securement system included

‘‘See-thru’’ inspection lid model option

⻫⻫

Yes Yes

Yes No

⻫⻫

Yes Yes Yes Yes Yes No

No No No No No No

Heavy molded plastic

⻫⻫

Metal

⻫⻫

a

Most bait stations can also be used as trap stations containing mousetraps or rat traps if pesticides are not desired or needed for the exterior program. b The Rat Cafeteria station is large enough to accommodate some of the multiple-catch mousetraps. Notes: Products listed alphabetically. No endorsement of any product is implied or intended. Labels should be checked to ensure product is registered for use in speciﬁc environments.

For example, bevel-edged, low-proﬁle stones serve well as anchor points and also lie low to the ground. Patio stones that sit higher than 1.5 in. (3.8 cm) off the ground may reduce the chances of mice readily entering the bait station. Cement blocks of approximately 12 ⫻ 12 ⫻ 1 in. (30 ⫻ 30 ⫻ 2.5 cm) provide a sufﬁcient support base yet lie low to the ground (Fig. 4). c. Trap Stations. Currently there is a general trend and emphasis in urban and industrial sectors of the United States to decrease the amount of pesticides that are used around buildings, especially around food manufacturing facilities [2,3]. Some food plants, in observance of this trend, elect to substitute rodent traps for some or all of the outdoor bait stations. Some plant managers also want to take every measure possible to preclude the accidental transport (by rodents or by an employee or visitor) of rodenticide baits (or any other pesticides) into the plant interior. To reduce pesticide loads around food plants, mousetraps (or rat traps for plants with rat pressure) can be installed inside rat-sized bait stations, thus converting them to trap stations [2]. The trap stations (Fig. 5) are deployed at intervals along exterior fences or walls as is done for conventional baiting programs. Depending on the particular station model used, snap traps can be placed in the bait holding compartment or next to the entry port of the station. To allow for multiple captures, each station should contain two traps. Place one or two drops of peanut oil, vanilla extract, or some other food volatile on the trap to serve as an attractant. Plastic-base mousetraps offer excellent hassle-free setting and good longevity in wet situations. The conventional wooden-base snap traps take too long to set and reset and the bases may warp when exposed to water. Trap stations may also be used to bait ants, cockroaches, crickets, and slugs where these perimeter pests are a problem. Some large-size bait station models are now available with clear lids facilitating easy inspection (Table 3). However, some stations may still need to be opened to facilitate recording the results on an inspection ticket. Some PMPs © 2003 by Marcel Dekker, Inc.

Figure 4 Bait or trap stations are typically installed along the perimeter foundation walls of food plants of warehouses at varying spacing as a second line of defense against rodents migrating from exterior areas to the building. Note the station is secured via the use of a heavy, low-proﬁle patio stepping stone.

Figure 5 Bait stations containing snap taps are recommended to capture any mice attempting to gain easy and quick entry nearby facility doors that are open for prolonged periods. © 2003 by Marcel Dekker, Inc.

and food plant personnel are changing over to bar code scanner inspection programs that involve inserting laminated, bar-coded tickets into bait or trap stations. Another technique tried by some PMPs is to put glue traps inside outdoor station boxes as a means to capture mice. However, glue traps used outdoors, even when placed inside bait stations, are likely to suffer the effects of being exposed to water, cold and heat, and dust and dirt being blown into the box or tracked in by exploring animals. Glue traps soon become ineffective under these conditions. d. Exterior Multiple-Catch Traps. Any of the multiple-catch mousetraps (also called curiosity traps) conventionally used for indoor perimeter walls (Table 4) can also be used for exterior trapping programs. Some facilities use MCTs outdoors spaced at the same intervals as bait stations. However, when employed in this manner, MCTs require more labor (inspections, recordkeeping, and cleaning) than snap-trap stations. These traps are perhaps best used in exterior areas as door ﬂanking traps. Of course, MCTs cannot capture rats. When metal MCTs are used outdoors, they perform best if installed within some type of protective cover. Otherwise, water, dirt, dust, and leaf litter get into the traps and render them ineffective due to corrosion and jamming. These traps also become difﬁcult to service and clean in a short time. Large (rat-sized) metal bait stations are available into which MCTs can be inserted to create an MCT station (Table 3). Plastic slip-over covers are also available for some models of MCTs. Heavy-duty plastic MCT models are now available from nearly all the mousetrap manufacturers (Table 4). Because plastic traps are less prone to corrosion or warping, and thus can be quickly inspected, they are better suited for outdoor control programs. However, for maximal capture efﬁcacy and trap longevity, outdoor plastic traps should be placed inside trap stations or have some similar cover to protect them from the elements. e. Placement/Spacing Guidelines for Bait and Trap Stations. Exterior rodent control programs for food plants should be designed so that they are responsive to speciﬁc plant operations and rodent pressures, as discussed previously. However, for routine rodent prevention programs, the general guidelines for exterior baiting and trapping programs are given here.

Table 4 Examples of Multiple-Catch Mousetraps Brand name 

Ketch-All Kwik-Katch Mini-Mouser Mouse Master Protecta MC PolyCat Repeater Tin Cat

Manufacturer

Wind-up

Kness Mfg. Gremar Corp. Kness Corp. Micro-Gen Bell Laboratories Woodsteam J. T. Eatons Woodstream

⻫⻫⻫⻫⻫

Trapdoor

Proﬁle size

⻫⻫⻫

High Medium Medium High Medium Low Low Low

Metal ⻫⻫⻫⻫

Plastic ⻫⻫⻫⻫

Notes: Products listed alphabetically. No endorsement of any product is implied or intended. Labels should be checked to ensure product is registered for use in speciﬁc environments.

© 2003 by Marcel Dekker, Inc.

• Property line fence: one bait/trap (B/T) station every 50–100 ft (15–30 m). • Building perimeter: one B/T station every 30–50 ft (9–15 m). Additional stations can be added at the discretion of the quality assurance (QA) manager or the contracted PMP. Because mice and rats tend to gravitate toward escaping warm air currents (or food odor currents), additional trap stations can be added to the building perimeter in those places where substantial heat or food odors emerge from under doors and from vents, openings around utility lines, and other similar openings. • A trap station (either snap traps within stations or multiple-catch traps within protective covers) should be positioned to ﬂank both sides of ramp bay doors or other ground level openings through which mice (even bait-poisoned mice) may gain easy entry. Mousetraps should also ﬂank both sides of the interior areas near these same locations. • Along areas of minimal or light rodent pressure, as well along walls that have no openings or structural faults, the maximal distances between B/T stations can be used or some stations can be selectively culled. • Bait/trap stations should be installed between any potential rodent harborage (stored equipment, debris, etc.) and any potential entry point to the plant. f. Inspecting, Servicing, and Recordkeeping of B/T Stations. For routine preventive programs, exterior B/T stations can be inspected on a weekly, biweekly, or monthly schedule, depending on the rodent pressure, time of year, company policy, and the types of baits or traps used. Exterior trap stations are usually checked weekly or every two weeks. Exterior bait stations containing standard food baits can be checked once to four times each month, depending on location, rodent pressure, climatic conditions, and/or company operating procedures. For example, fence row stations containing one or two bait blocks on plant properties that have low rodent pressure probably need not be serviced more often than once or twice per month. Bait/trap stations located along exterior plant walls should be checked weekly. Most rodenticide baits have an outdoor longevity of about 4–6 weeks. Baits that are moldy or deteriorated should be changed out sooner than this. In stations where the bait is consistently untouched, traps can be installed (replacing the bait stations) or the station simply removed. Proper recordkeeping of B/T stations is important not only to comply with various company and contract guidelines, but also to help identify the rodent pressure affecting the plant complex. Records should be reviewed on a regular basis (e.g., quarterly and annually). These records can then be put to use in customizing a speciﬁc defense program for a particular food plant. Good records also demonstrate to regulatory or private inspectors that a well-organized rodent control program is currently in place. All B/T stations are numbered and tagged with a service ticket that lists (1) the date of last inspection, (2) initials of the inspector, (3) the rodenticide (if one is used) active ingredient, and (4) the name and phone number of the responsible individual or company servicing the stations. Records should reﬂect the level of rodent activity in the outdoor stations. It is important for inspectors to be competent to identify speciﬁc evidence of rodent activity. For example, some inspectors mistakenly identify cockroach and cricket droppings as mouse droppings or toad droppings as rat feces [19]. Bar codes and scanning technology have become commonplace for industrial rodent control programs. Such systems both save time and accurately record inspection results © 2003 by Marcel Dekker, Inc.

scanned from laminated, bar-coded tickets installed inside the bait or trap stations. Many PMPs utilize laminated punchcards to certify that a station has been serviced according to schedule. Two speciﬁc forms should be kept on ﬁle as evidence of an effective, long-term rodent pest management program for a food plant: (1) A general inspection sheet in table format that indicates for each bait or trap station the dates of inspections, rodenticide active ingredient (if one is used), evidence of activity, and other appropriate information and (2) a diagrammatic sketch illustrating the location of all exterior B/T stations. Copies of the data and the diagram should be ﬁled with the appropriate plant personnel, inspectors, and the contracted pest control company, if one is used. g. Inspections During Snow Cover. The kind and frequency of service to be provided during periods of snow cover should be determined by the history of the rodent activity at a particular location. If exterior stations are subject to ongoing rodent activity, several (e.g., four to six) bait blocks can be installed within the stations beginning in early winter (in other stations, one or two precautionary bait blocks per station should be sufﬁcient). When heavy snow cover prevents ready access to the stations, the extra baits will provide the necessary protection until the snow melts and the normal service schedule can be resumed. It is unusual for snowfall to keep bait stations inaccessible for more than 6–8 weeks. It is generally unnecessary to dig out and inspect each station solely for the purposes of recordkeeping. 4. Defense Line 3 Despite well-maintained food plants and warehouses and state-of-the-art rodent pest management programs, a few mice (and the occasional rat) inevitably gain entry to food plants. Therefore, the third line of defense against rodents involves the use of rodent traps positioned along interior perimeter walls at the ground ﬂoor level. Other ﬂoors and areas (e.g., grain elevator ﬂoors) may also require trap placements as determined by the nature of the building structure and level of rodent pressure encountered. It is important for food plant personnel to note that the action threshold for rodents inside food plants is one rodent. One mouse can produce up to 50 (sometimes more) droppings, as well as numerous deposits and thousands of microdroplets of urine in a 24hr period [5,20]. It is possible, then, for just one mouse to rapidly contaminate a wide range and quantity of food product or food processing equipment. Thus, the presence of even one mouse inside a food plant warrants immediate attention. Real-world records and experiences over the past several decades from many different food plants and PMPs across the United States have illustrated that in well-maintained plants (regardless of size), with good pest-prooﬁng, employee cooperation on keeping doors closed, and effective exterior rodent prevention programs, the number of mice that gain entry on an annual basis is usually low (e.g., rarely more than a half dozen or so). Plants ﬁtting this proﬁle but also located in areas of low natural mouse populations may not experience any mice (or only one or two) indoors over a period of several years. On the other hand, plants that are situated near high natural populations of mice may capture a dozen or so mice indoors each year in spite comprehensive rodent pest management programs and strict adherence to GMPs. The rodent management programs of those food-manufacturing facilities, including even very large ones, in which more than a dozen or so mice are captured indoors annually, signal a need for additional ﬁne tuning. In these situations there may have been failures © 2003 by Marcel Dekker, Inc.

in the basic elements of some, if not all, of the components of the rodent IPM program as outlined and discussed in this chapter (rodent exclusion, sanitation, and the three lines of defense). Considering these factors, it should be apparent that interior rodent control programs must be well designed and carefully implemented. In nearly every food plant, interior mice are controlled by traps, usually MCTs. In exceptional situations, rodenticidal baits are sometimes used for short periods to knock down infestations that, for whatever reason, have become established (e.g., mice introduced to a plant or a warehouse via an infested railcar or truck trailer) (see Section III.C.3.b for guidelines on the use of rodenticides inside a food facility). a. Interior Trapping Programs. Interior trapping programs involve the use of either plastic or metal MCTs deployed along the interior side of all exterior (perimeter) walls. Mice exploring strange new environments enter these traps, presumably to seek immediate shelter. Captured mice usually succumb to hypothermia or to other physiological stresses associated with capture and conﬁnement. (See Table 4 for the most commonly used multiple catch traps.) Glue boards, now commonly added to MCTs (Fig. 6), facilitate expedient mouse captures and removals and trap cleaning, as well as reduce biohazards and provide a supplemental method for pest insect monitoring [2]. This combined approach, using glue traps inside MCTs, is both cost and time efﬁcient for mouse control and, as an added beneﬁt, for pest insect monitoring. Some PMPs and food plant personnel are loyal to only one brand of MCT, believing their favorite to be the superior mouse catcher. Others select among the different trap

Figure 6 A trapdoor, multiple-catch mousetrap for interior areas. Glue boards can be installed into these traps rendering the trap both a mousetrap and a device for monitoring for the presence of cockroaches, ants, and many other insect pests of importance to a food plant. © 2003 by Marcel Dekker, Inc.

types and brands as local situations dictate. So far, ﬁeld trials have not proven any difference between the various models in their ability to capture mice [21,22]. But there are differences among traps relative to durability and ease of servicing, cleaning, repairing, and handling [23]. trap placement, densities, and positioning. Multiple-catch traps must be placed in locations that maximize the chances of any incoming mice encountering the trap. Most mice entering a strange building for the ﬁrst time (whether from the outside or from a delivery vehicle) tend to scurry about from one protective nook and cranny to another. Thus, for preventive and maintenance mouse control programs, MCTs are typically spaced along the entire interior perimeter (usually on the inspection line) of the plant’s exterior walls in an effort to intercept such new arrivals. Spacing guidelines for conventional rodent management programs call for one trap to be installed along the sanitation lines every 20–40 ft (6.5–13 m). Facilities with nil to minimal mouse activity can employ the maximum distance between the traps or, alternatively, traps can be installed in those areas most vulnerable to mouse entry. Interior walls that divide rooms or warehouse sections do not require a trap line unless circumstances (e.g., interior ingredient sheds, etc.) dictate the need. MCTs should be placed at or near potential mouse entry locations such as on both interior sides of exterior doorways, near utility openings through walls, and at other openings to the outside. In cases where an active mouse infestation develops or is discovered, MCTs can be located in areas such as darkened corners, runways along walls and pallets, behind appliances and other large objects, in suspended ceilings, and in all other areas where inspection determines mouse activity. The positioning of the trap entrances of the wind-up models in relation to a wall is not of critical importance to the trap’s effectiveness, although in some cases one position may prove to have an edge over another position. A barrier-type placement (i.e., the trap placed perpendicular and ﬂush against the wall so that the mouse must stop and enter or run around the trap) may be more effective for capturing newly arriving mice such as those darting into a warehouse via the bay doors (Fig. 7). When placing the traps so that the entrance is facing the wall, a space of 1.5 in. (3.8 cm) between the wall and the trap should be used. This creates an ‘‘alleyway’’ between the trap and the wall. Such spaces are attractive to rodents; they will investigate the hole they ﬁnd in the alleyway. When wind-up MCTs are used in situations of established mouse populations, the mice will investigate the traps at their leisure, and either position can be used. With the trap-door mousetrap, the trap should be positioned so the trap entrances are closest to the wall or to suspected mouse runways. servicing multiple-catch traps. Multiple-catch traps must be kept clean and well maintained. Traps that are not cleaned regularly can serve as sources of ﬁlth contamination. Although it is true that traps with ‘‘mousey odors’’ from previous captures tend to capture more mice than traps without such odors, this does not warrant leaving unserviced a trap that contains hair, body parts, or foul odors in any food plant environment. In less sensitive areas of the plant (e.g., nonfood areas), traps can be ‘‘cleaned’’ using a wire brush, a rag, and a putty knife to remove dead bodies and associated dirt. This procedure will not eliminate any residual odors. The use of glue boards inside the MCTs helps to keep the traps clean and facilitates fast servicing of traps containing mice. Rancid or dirty traps should be removed from the premises and replaced with new or clean traps. Enclose and seal dirty traps inside plastic bags while they are transported out of the food facility. Some plant procedures stipulate that any trap that has caught a © 2003 by Marcel Dekker, Inc.

Figure 7 Wind-up multiple-catch mousetraps should be checked weekly for the presence of any mice. Mice enter MCTs as an opportunistic response to investigate new holes in their territories or in their attempts to quickly locate new protective harborages when they enter unfamiliar environments.

mouse or other animal must be replaced, sanitized, or steam cleaned after each capture. In many cases, it is more cost effective to simply discard very dirty traps. Most MCTs now come with transparent plastic inspection plates. Simply by looking through the inspection port, the inspector can see immediately if there is a live mouse or other animal in the trap before opening it. This saves considerable time when many traps need to be inspected and serviced. The presence of ‘‘see-thru’’ plates has no effect on whether or not mice enter the traps. However, all traps should be opened and thoroughly inspected before being put back into service. Shining a light through the viewing holes or inspection plate as the only inspection step is not sufﬁcient. Mice may be hiding in, or next to, the tunnels in the lowproﬁle model, and mice may be trapped in the back area of the wind-up traps. Moreover, dead mice, crickets, beetles, and other objects may become lodged between the various parts of the MCTs, rendering the trap ineffective or serving as a source of bacterial contamination. Periodic maintenance and repairs of traps are essential to ensure the traps remain effective and easy to inspect. Inspecting traps that are difﬁcult to open, close, wind up, and redeploy can be time consuming and thus costly. Moreover, it is annoying to handle traps in disrepair; sometimes pest management personnel just ignore the difﬁcult traps. When the panels of sheet metal traps warp, they must be repaired. Traps with gaps in side and end panels serve no purpose at all; mice will likely escape from ‘‘gappy’’ traps or from traps that are broken or malfunctioning. Minor repairs on metal traps can often be done on site. The covers can be waxed with candle wax and oiled to make the panels open or slide with ease. Wind up and treadle © 2003 by Marcel Dekker, Inc.

door mechanisms of MCTs should be oiled periodically (use mineral oil). Tools such as a putty knife, small pliers for repairing bent metal, a long thin screwdriver, and a small vial of light pharmaceutical-grade mineral oil (no odor) can be carried in the inspector’s belt pouch for on-the-job trap maintenance. Alternatives to the sheet metal traps are the relatively new plastic MCTs. These traps are easier to handle, inspect, and keep clean, and there are no bent metal panels to repair. Plastic traps also have greater utility in wet areas (sheet metal traps exposed to water corrode quickly). On the other hand, when a plastic trap gets bumped by a forklift or when some other mechanical force creates a hole or crack, there is no saving the trap (some sheet metal traps exposed to such abuse might be salvaged). installing mousetraps in forklift traffic areas. In areas of food plants and warehouses where traps are subject to forklift trafﬁc, maintaining MCTs can be frustrating, difﬁcult, and costly. In these areas the traps are regularly bumped, nudged, or ruined by the forklifts. Even a minor bump by a forklift truck against a plastic trap usually results in gaps or warped and split panels. Since mice can escape through gaps only 0.25 in. (6 mm) wide, such minor gaps render the trap ineffective. Moreover, dinged traps are difﬁcult and annoying to service by the attending technician and are time consuming when they need to be repaired. Metal protective covers, available from manufacturers or local machine shops, serve to signiﬁcantly protect the mousetraps from the occasional minor accident. However, a direct hit by a forklift on a trap usually demolishes both the trap and its cover. For areas subject to constant forklift activity, glue board or snap-trap stations made of polyvinyl chloride (PVC) may be more cost effective without compromising effectiveness. To protect a glue board station, use heavy-duty PVC tubing, 1.5 in. (3.8 cm) in diameter. To protect the small, clam-style mousetraps, use 2-in. (5.1-cm) diameter tubing [2]. Cut the PVC pipe into lengths of approximately 9 in. (23 cm). Insert any of the standard, inexpensive cardboard glue traps into the PVC pipe. To make a trap station, put one of the plastic, clam-style mousetraps into each end of the pipe. Because of its shape, the PVC trap station ﬁts snugly against the wall–ﬂoor junction, out of the way of forklifts and other trafﬁc. The wall–ﬂoor junction is also where mice and insects typically travel. These pipe stations are not as vulnerable to accidental contact as the boxy MCT traps. Because of the strength of the circular plastic tube, the PVC trap station can withstand virtually any amount of weight and/or forklift contact. In warehouses that have constant forklift–mousetrap interactions, the PVC trap station system can mean signiﬁcant savings over the course of a year, besides guaranteeing that working traps are always in place. The PVC glue trap works as both a forklift-proof mousetrap and as an insect monitoring trap. This trap can also be installed onto ledges, overhead beams, and other locations where conventional traps and monitoring devices do not ﬁt. The PVC trap is afﬁxed by the use of self-adhesive, heavy-duty Velcro  fabric. One strip of Velcro (about 4 in., or 10 cm, long) attached to the PVC tube is pressed against the complementary Velcro strip glued to the wall surface. A self-adhesive inspection label (available with many of the standard MCTs and bait stations) can be afﬁxed to the outside of the trap station. The PVC trap is also suitable for wet situations that would cause corrosion and eventual malfunction of metal mousetraps. However, substantial wetness may, given suf© 2003 by Marcel Dekker, Inc.

ﬁcient time, neutralize the sticky surface of glue traps, rendering them ineffective. In these cases, either plastic MCTs or PVC snap-trap stations might be appropriate. The PVC glue trap is not appropriate in cold storage areas or near doors and other areas subject to freezing temperatures because these glues do not perform adequately in cold temperatures. Nor is the PVC glue trap appropriate in areas where there may be abundant dust or debris. In these areas, the PVC snap-trap stations would be used. Like the standard MCT traps, PVC traps need to be checked weekly to replace any dusty glue boards or to reset snap traps. Some adult mice tend to avoid stepping onto sticky surfaces. Also, forklifts hitting the PVC snap-trap stations often trip the enclosed mechanism. Still, for those factories or warehouses where the occasional mouse is the typical scenario, a PVC glue trap in working condition in high forklift activity areas holds greater potential for capturing mice than beat-up, warped, or gappy MCTs. As an aside, and as a bonus for PMPs faced with this difﬁcult problem, pest sparrows moving about inside a building have a propensity for entering PVC glue traps (especially when birdseed is set out as a bait at the tube entrance and just inside the trap station). b. The Use of Rodenticide Baits Inside Food Plants. Much concern (and confusion) exists within the food and the pest management industries regarding the use of rodenticide baits inside food plants. In general, most food plants restrict the use of baits to exterior areas and employ only trapping programs for interior areas. However, regulations do allow for baits to be used inside all areas of food plants regulated by both the Food and Drug Administration and the U.S. Department of Agriculture (USDA) if (1) conditions warrant such use; (2) they are used in such a manner so as to not present an adulteration threat; and (3) in the case of USDA facilities, they are used with the permission of the inspector in charge under the speciﬁc USDA guidelines for such use. Many food plants operate on a general philosophy that the risks of using baits inside the plant outweigh their value. The risks associated with using baits inside food plants include the following: No control over the recovery of poisoned rodents. Rodents may translocate the bait and contaminate product. (With the new bait securement technology, this issue is of much less signiﬁcance than in years past.) Damage from forklifts or other plant operations may scatter bait, and thus present a contamination potential. (Careful placement negates this concern.) Baits may attract and serve as a breeding medium for stored-product or other insects (not very likely unless baits are ignored for prolonged periods). A disgruntled employee might sabotage product by inserting the bait into product or product containers (true, but such an employee might use any one of many different chemicals or objects to sabotage product). Some argue that the risks associated with bait applications are insigniﬁcant or minimal when baits are applied using proper precautions and suitable bait stations, adhering to federal and in-house regulations and using only the meal or secured block formulations to minimize bait translocation. But others contend that if any possibility, however small, of bait contamination exists, this is reason enough not to allow their use inside a food plant. © 2003 by Marcel Dekker, Inc.

In general, if a plant is employing good exterior rodent control, effective rodentprooﬁng, and good sanitation programs, rodent baits should have only a minor or ‘‘last resort’’ role for use inside a plant. But a policy or attitude of never allowing baits inside the food plants may not be justiﬁed based on risk alone and does not recognize the reliability of a comprehensive rodent control program. Here are some examples of situations when baiting inside food plant may be required: Some mice and rats will not respond to snap traps and/or glue traps. Where there is a major infestation or a persistent rodent problem, a management plan that involves the integrated application of as many rodent control tools as possible is the one most likely to achieve the fastest reduction of the rodent population. By using this multifaceted, integrated approach in a timely manner, the chance of adulteration of the product by rodents is markedly reduced. Some important considerations regarding the use of rodenticides inside food plants are as follows: Inside USDA-regulated food plants, permission to use pesticides must be granted by the inspector-in-charge, and all USDA regulations and guidelines must be carefully followed. Rodenticides should not be used indoors as an ongoing, preventive program. Bait stations should be deployed only in areas of chronic activity as determined by thorough inspections. Only the minimal effective amounts of bait per placement and only those formulations and bait stations that minimize the possibility of bait translocation (e.g., secured bait blocks) should be used. Baits should never be installed where they may be impacted by foot or forklift trafﬁc. Daily monitoring and strict recordkeeping must be the rule for all bait placements. All baits should be removed and careful follow-up monitoring resumed upon successful eradication of the rodents, and preventive trapping programs should be continued. D.

Monitoring Rodent Pressure

It is common practice in food plants to maintain individual inspection tickets or bar codes on each B/T station and interior MCT, showing the date of inspection and the activity status for each station or trap. However, valuable rodent control information can be developed if a log of all captures for each trap is maintained on a monthly, quarterly, and yearly basis. Bar-coded and scanned capture data are easily gathered and downloaded for analysis. Simple plot diagrams, overlaid onto a plant or warehouse ﬂoor plan, can pinpoint those areas of a plant or warehouse that are most vulnerable to mouse invasions from outdoors, as well as clearly indicating those areas that may be adequately serviced by only the minimum number of trap or bait stations. What is the point of maintaining and inspecting traps that on an annual basis for several years never record a rodent capture? Such stations can be either removed or moved to an area where they will do more good (general inspections should, however, continue in those areas left without traps). Similarly, suppose the capture plot data reveal that a part of the plant is repeatedly receiving mouse or rat activity. Such areas must be evaluated © 2003 by Marcel Dekker, Inc.

as to why there is recurring rodent activity and measures must be taken to remedy the problem (e.g., implementing a rodent exclusion program; increasing the number of traps or exterior bait stations). Those perimeter walls of a facility that face areas of potential rodent harborage such as ﬁelds, ditches, weedy patches, ornamental plantings, etc., are more likely (but not always) to have greater rodent pressure than those sides bordered by parking lots. The number of rodent control devices set out in any particular area either inside or outside a food factory should be calculated on both the rodent capture history and the potential for rodent incursions from adjacent habitats with suitable rodent harborage. E.

Miscellaneous Approaches: Ultrasonic and Other Electronic Devices

Some food plant and warehouse personnel occasionally inquire about or purchase various models of ultrasonic machines or other ‘‘electronic repellers’’ designed to drive rodents away from buildings. A few experts in food sanitation have allowed that ultrasonic machines can enhance protection to a level over and above what might be expected from standard baiting and trapping programs [8]. Every few years or so, manufacturers of ultrasonic repeller machines claim to have made new breakthroughs that make their products even more effective than before. It is important to note, however, that no reports of formal scientiﬁc experiments proving the efﬁcacy of these units around commercial food plants, warehouses, or other commercial buildings have been published in any peer-reviewed scientiﬁc journal during the 35 years that these devices have been marketed. Of course, it has been demonstrated, under laboratory or other very closely controlled conditions, characterized by a minimal number of environmental variables, that locomotory activities of rats and mice can be affected to some extent by ultrasonic beams [24,25]. However, rarely is the foraging behavior of hungry rodents struggling for survival in the wild as simple as the behavior that would be observed in observation arenas or laboratory settings. There are many environmental and structural variables in and around food factories and warehouses that affect the path and intensity of ultrasonic waves and that attenuate their effects, if any, on incoming rodents (e.g., predicted path of the rodents; alternative pathways; trucks, pallets, and products causing sound shadows; the physical condition and biological drive of the speciﬁc rodent). Also, the number of doors needing coverage in a typical food plant or warehouse would, in some cases, require a relatively expensive investment in ultrasonic equipment. Considering the proven effectiveness of a quality, comprehensive rodent IPM program, the questionable certainty of deriving a cost beneﬁt from adding these unproven devices is indeed problematical [1,21,27]. IV. SUMMARY Most food plants are subject to signiﬁcant rodent pressure, mostly from the common house mouse, during the course of a year. Keeping incidents of rodent infestation few or nonexistent requires a serious commitment by food plant management to implement exceptional exterior and interior good manufacturing practices relative to pest-prooﬁng and sanitation efforts. Good manufacturing (or warehousing) practices must then be backed up with a comprehensive rodent pest management program. Taken together, these programs become a working deﬁnition of integrated pest management. © 2003 by Marcel Dekker, Inc.

The choices of speciﬁc kinds of stations, bait formulations, and traps, as well as the particulars of placement and servicing of all these devices, are important considerations in the overall goal of achieving thorough and cost-effective protection of a food plant from rodents. However, the food industry (and pest management professionals) should avoid implementing yard-stick, one-size-ﬁts-all rodent control programs that are the same for every plant without regard for each plant’s speciﬁc history, type of operation, location, and building construction. Rodent activity and capture data should be maintained and analyzed on a quarterly basis to design site-speciﬁc rodent management programs that are efﬁcient and thus cost effective. Food plant professionals should be wary of electronic repellers or any other untested technology that claims to protect food plants with nothing more that the plugging in of some gadget into an electric outlet. Rather, food plant managers should rely on correctly established and well-maintained IPM programs. Finally, and most importantly, exterior bait stations and interior preventive traps— even when installed to maximal levels—cannot compensate for deﬁciencies in sanitation and pest-prooﬁng. REFERENCES 1. AIB. Consolidated Standards of Food Safety. Manhattan, KS: American Institute of Baking, 2001. 2. RM Corrigan. Rodent pest management for the food and warehousing industry. In: Rodent Pest Management: A Practical Guide for Pest Management Professionals. Cleveland, OH: GIE Media, 2001. 3. SC Frantz, DE Davis. Bionomics and integrated pest management of commensal rodents. In: JR Gorham, ed. Ecology and Management of Food-Industry Pests. Arlington, VA: Association of Ofﬁcial Analytical Chemists, 1991, pp 243–313. 4. AN Meyer. Rodent control in practice: food stores. In: A Buckle, R Smith, eds. Rodent Pests and Their Control. Wallingford, UK: CAB International, 1994, pp 273–290. 5. FH Bronson. The adaptability of the house mouse. Scientiﬁc American 250(3):116–125, 1984. 6. WZ Lidicker. Social behaviour and density regulation in house mice living in large enclosures. J Animal Ecology 45:677–699, 1976. 7. JL Hurst. The complex network of olfactory communication in populations of wild house mice, Mus domesticus Rutty: urine marking and investigation within family groups. Animal Behavior 35(5):705–725, 1989. 8. T Imholte, T Imholte-Tauscher. Engineering for Food Safety and Sanitation: A Guide to the Sanitary Design of Food Plants and Food Plant Equipment, 2nd Ed. Woodinville, WA: Technical Institute of Food Safety, 1999. 9. AG Jenson. Prooﬁng of Buildings Against Rats, Mice and Other Pests. Ministry of Agriculture, Fisheries and Food Technical Bulletin 12. London: HMSO, 1979. 10. HG Scott. Design and construction: building out pests. In: JR Gorham, ed. Ecology and Management of Food-Industry Pests. Arlington, VA: Association of Ofﬁcial Analytical Chemists, 1991, pp 331–343. 11. RM Corrigan. The science behind the inspection aisle. The Sanitarian 3(1):6, 10–11. 12. V Walter. Justifying the warehouse perimeter strip. Pest Control 50(10):46, 1982. 13. USDI. Rat Control Methods. U.S. Department of the Interior Fish and Wildlife Service Circular 13, 1948. 14. USDI. Control of House Mice. U.S. Department of the Interior Fish and Wildlife Service Wildlife Leaﬂet 349, 1953. 15. J Silver, FE Garlough. Rat Control. U.S. Department of the Interior Fish and Wildlife Service Conservation Bulletin 19, 1941.

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16. AOM. Section I: Federal Food Drug and Cosmetic Act of 1938 as It Now Applies to the Grain Trade. Section II: AOM’s Sanitation Committee’s Suggested Procedure. Association of Operative Millers Bulletin, May, pp 1958–1962, 1952. 17. RT Cotton. Pests of Stored Grain and Grain Products. Minneapolis, MN: Burgess Publishing Company, 1956. 18. JA Troller. Sanitation in Food Processing. New York: Academic Press, 1983. 19. RM Corrigan. Exterior rodent baiting programs. Pest Control 60(7):33–37; 60(8):38–41, 1992. 20. FP Rowe. Wild house mouse biology and control. In: RJ Berry, ed. Biology of the House Mouse. Symposia of the Royal Zoological Society of London No 47, pp 575–589, 1981. 21. M Temme. House mouse behavior in multiple-catch traps. Pest Control 48(3):16, 18–19, 1980. 22. RM Corrigan. Multiple catch traps: trapping strategies. Pest Control Technol 16(9):45–50, 1988. 23. RM Corrigan. Evaluating multiple catch mousetraps. Pest Control Technol 21(8):36–46, 1993. 24. SA Shumake, AL Kolz, KA Crane, RE Johnson. Variables affecting ultrasound repellency in Philippine rats. J Wildlife Management 46(1):148–155, 1982. 25. JH Greaves, FP Rowe. Responses of conﬁned rodent populations to an ultrasound generator. J Wildlife Management 33(2):409–417, 1969. 26. M Lund. Ultrasound devices. In: A Prakash, ed. Rodent Pest Management. Boca Raton, FL: CRC Press, 1988, pp 407–409. 27. WE Howard, RE Marsh. Ultrasonics and electromagnetic control of rodents. Acta Zoologica Fennica 173:187–189, 1985. 28. RM Corrigan, J Klotz. Food Plant Pest Management (correspondence course). West Lafayette, IN: Purdue University, 1995. 29. GW Bennett, JM Owens, RM Corrigan. Truman’s Scientiﬁc Guide to Pest Control Operations, 5th Ed. Duluth, MN: Advanstar Communications, 1997. 30. M Holcomb. Clean up your act, or the bugs may take over. Pest Control 65(11):78, 1997.

© 2003 by Marcel Dekker, Inc.

19 Insects and Mites LINDA MASON Purdue University, West Lafayette, Indiana, U.S.A.

I.

INTRODUCTION AND IMPORTANCE

Arthropod pests cause considerable losses to the food industry. It is estimated that pests may cause postharvest losses between 8 and 25% in developed countries and as high as 70–75% in developing countries [1]. These losses could be in the form of direct product loss due to pests consuming food or to arthropod fragments and feces causing contamination. Direct consumption by arthropod pests most often happens in raw commodities but can also occur in ingredients and ﬁnished products. Insect and mite pests may also change the taste of food products by adding their secretions, excrement, and dead bodies to the food. Sawtoothed grain beetles and merchant grain beetles can impart a strong off-ﬂavor if infested ingredients are processed into ﬁnished product. (Scientiﬁc names for all arthropods mentioned in this chapter are given in Table 1). Red and confused ﬂour beetles secrete a disagreeable odor from their scent glands that makes heavily infested ﬂour unusable. Insect fragments may also pose a health hazard [2]. Larval dermestid beetles are clothed with barbed hairs (hastisetae) that may be of some danger to infants if consumed in large quantities. Another important emerging issue associated with arthropod contamination of food is arthropod-borne allergens. Consumption of insect or mite fragments or byproducts (cast skins, excreta, and pheromones) may provoke severe allergic reactions in highly sensitive individuals [3]. Finally, because some insects (especially cockroaches, ants, and ﬂies) have the potential to carry disease-causing bacteria, these and other arthropod pests are a major concern to the food industry and one that should be taken seriously [4,5].

© 2003 by Marcel Dekker, Inc.

Table 1

Scientiﬁc Names of Arthropod Taxa Noted in This Chapter

Common name American cockroach Angoumois grain moth Ants Australian spider beetle Beetles Black carpet beetle Booklice Brownbanded cockroach Brown cockroach Brown spider beetle Cabinet beetle Cheese mite Cigarette beetle Cluster ﬂy Cockroaches Confused ﬂour beetle Dark mealworm Dermestid beetles Drosophilid fruit ﬂy Drugstore beetle Face ﬂy False powderpost beetles Filth ﬂies Flat grain beetle Flies Fruit ﬂies German cockroach Grain mite Granary weevil Ground beetles Indianmeal moth Khapra beetle Lesser grain borer Maize weevil Mealworms Mediterranean ﬂour moth Merchant grain beetle Mites Moth ﬂies Moths Oriental cockroach Phorid ﬂy Psocids Red ﬂour beetle

© 2003 by Marcel Dekker, Inc.

Scientiﬁc name

Family

Other category

Periplaneta americana Sitotroga cerealella — Ptinus ocellus — Attagenus unicolor — Supella longipalpa Periplaneta brunnea Ptinus clavipes Trogoderma glabrum Tyrolichus casei Lasioderma serricorne Pollenia rudis — Tribolium confusum Tenebrio obscurus — — Stegobium paniceum Musca autumnalis — — Cryptolestes pusillus — — Blattella germanica Acarus siro Sitophilus granarius — Plodia interpunctella Trogoderma granarium Rhyzopertha dominica Sitophilus zeamais Tenebrio spp. Anagasta kuehniella Oryzaephilus mercator — — — Blatta orientalis Megaselia scalaris

Blattidae Gelichiidae Formicidae Ptinidae — Dermestidae — Blattellidae Blattidae Ptinidae Dermestidae Acaridae Anobiidae Calliphoridae — Tenebrionidae Tenebrionidae Dermestidae Drosophilidae Anobiidae Muscidae Bostrichidae [Several families] Cucujidae — Drosophilidae Blattellidae Acaridae Curculionidae Carabidae Pyralidae Dermestidae Bostrichidae Curculionidae Tenebrionidae Pyralidae Cucujidae — Psychodidae — Blattidae Phoridae

Tribolium castaneum

Tenebrionidae

Dictyoptera Lepidoptera Hymenoptera Coleoptera Coleoptera Coleoptera Psocoptera Dictyoptera Dictyoptera Coleoptera Coleoptera Acari Coleoptera Diptera Dictyoptera Coleoptera Coleoptera Coleoptera Diptera Coleoptera Diptera Coleoptera Diptera Coleoptera Diptera Diptera Dictyoptera Acari Coleoptera Coleoptera Lipidoptera Coleoptera Coleoptera Coleoptera Coleoptera Lepidoptera Coleoptera Acari Diptera Lepidoptera Dictyoptera Diptera Psocoptera Coleoptera

A. Basics: What Makes an Insect or a Mite? 1. Mites In the food industry, we are primarily concerned with insects and mites (spiders, considered occasional invaders, pose very little risk to food products). Although mites and insects are arthropods, there are differences between them that are important both in the control and in the identiﬁcation of these two groups. Mites belong to the class Arachnida (insects are in the class Insecta). Arachnids have two body regions (cephalothorax and abdomen) without wings or antennae. Adults and nymphs have four pairs of legs; larvae have only three pairs of legs (they acquire the fourth pair after the ﬁrst molt). Most mites undergo a form of simple metamorphosis (egg, larva, nymph, and adult); the ﬁrst instar is called a larva and the remaining immature stages are nymphs. 2. Insects Insects have one pair of antennae, three body segments (head, thorax, and abdomen), and three pairs of legs. Some kinds of insects also have one or, more typically, two pairs of wings (rarely absent except for immature stages). The thorax is composed of three segments: prothorax, mesothorax, and metathorax. Each thoracic segment usually bears a pair of legs; the wings are attached to the meso- and metathorax. Characteristics of the prothorax are often used to identify insect species. In some orders (e.g., Coleoptera—beetles and weevils), the front pair of wings is hardened into a thick covering that protects the second pair of wings. Most of the foodinfesting pests are very small (microscopic to 0.04 cm for mites; up to 0.63 cm long for some of the beetles). Other useful morphological characteristics used to identify insects are the six parts of the jointed leg. The most distal region of the leg, the tarsus, is composed of several segments that can vary in number on each pair of legs or the number may be identical on each pair. Comparing the number and shape of these segments helps to identify similar-looking insects (e.g., adult mealworms versus adult ground beetles). B. Metamorphosis Insects undergo a series of morphological changes as they progress from hatchlings to adults. These changes in form are termed metamorphosis. The two most common types of metamorphosis are (1) simple and (2) complete. 1. Simple Metamorphosis Cockroaches and psocids are examples of insects that have simple metamorphosis. These insects go through three distinct phases: egg, nymph, and adult. The immatures (nymphs) are smaller but resemble adults in general appearance although they lack wings (some may have wing buds if the adults of the species possess wings). Nymphs grow into adults by molting several times, each time increasing their size and body proportions. Control strategies for these species are usually less complex because the adults and immature have similar food and shelter preferences and also look alike, which makes identiﬁcation easier. 2. Complete Metamorphosis Common food pest insects with complete metamorphosis are beetles, moths, ants, and ﬂies. The stages of complete metamorphosis are egg, larva, pupa, and adult. Each stage is completely different in form and may also vary in food and habitat preferences. Wings © 2003 by Marcel Dekker, Inc.

develop internally; there are no compound eyes during the immature stages; and there is a period of apparent inactivity (pupal stage) prior to adult emergence. Although identiﬁcation is usually based on the adult stage, larvae of this group are often the most destructive stage. The pupal stage is a nonfeeding, transitional stage. The egg and pupal stages are the most difﬁcult to control due to low respiration rates and lack of movement. C.

Growth and Development

The rate at which an insect grows and develops through metamorphosis is very dependent on ambient conditions. Without a thorough understanding of this concept, control of food pests is very difﬁcult. If the temperature, humidity, and food requirements are not within species-speciﬁc ranges, the insect may exhibit retarded development. Normally it takes an insect 30–45 days to complete one life cycle (egg to adult) (studies of this kind are usually done under conditions of 21°C and 70% relative humidity (rh), often referred to as standard laboratory conditions. All developmental period durations are highly sensitive to ambient temperatures, humidities, and nutritional factors). If the environmental temperature is lowered, the life cycle may increase in duration; if the environmental temperature increases, the life cycle may shorten to somewhat less than average. If the environmental temperature exceeds the endpoint extremes (either too high or too low) for development, the insect may die or enter into a dormant phase. Some aspects have the ability to diapause, or go into a dormant state, before conditions become unfavorable. The chief factor that initiates diapause is day length. However, certain food and temperature variables can induce it in some insects. Typically, temperatures below 5°C cause death; between 13–20°C development stops; between 13–25°C and 33–35°C development slows; the range of 25 to 33°C is ideal; above 35°C death can occur. Plant managers can use this information to determine the rate at which insect populations will grow within a food processing facility. Under warmer conditions, the pest populations will grow rapidly, quickly getting out of control if management procedures are not undertaken. Extreme temperatures can be used to manage food-facility pests. Many processing facilities are using heat ‘‘sterilization’’ (heating a facility to temperatures exceeding 54.5°C for an extended period of time) to kill insects within a structure or commodity. Several precautions are needed and expert advice should be sought prior to doing a heat sterilization of a facility.

II. PEST SUMMARIES Stored-product pests are usually categorized into two groups, based on characteristics of their life cycle. Internal pests spend most of the feeding portion of their life cycle within a whole seed or kernel of grain; only rarely do they feed in processed foods. Examples of internal feeding pests include the weevils, the lesser grain borer, and the Angoumois grain moth. External or surface feeders usually feed on processed foods. They spend the majority of their lives on milled grains and grain-based food products. Adults of some species can utilize certain nonfood products, speciﬁcally pollens and molds. The destructive life stages, however, are found in processed foods. © 2003 by Marcel Dekker, Inc.

A. Internal Feeders 1. Weevils Adults of the rice, maize, and granary weevils measure from 0.3 to 0.6 cm in length. Adult weevils are commonly called snout beetles because the head is elongated into a ‘‘snout’’ that contains the mouthparts. The larvae are small, white, legless grubs that spend the entire larval stage inside whole kernels of grain. After a mated female oviposits a single egg into the center of each kernel, she covers the resulting hole with a gellike, foamy material. Under standard laboratory conditions, the eggs hatch in a few days; then the larvae feed within the kernel for about 1 month; then they pupate, emerging as adults 1–2 weeks later. Rice and maize weevils are capable of ﬂight; granary weevils cannot ﬂy. 2. Lesser Grain Borer The adult lesser grain borer is a cylinder-shaped, dark-brown beetle about 0.3 cm long. Its head is tucked so far under the prothorax that it is not visible from above. This beetle belongs to a family known as the false powderpost beetles. Although most species in this family infest wood and bamboo, the lesser grain borer specializes in consuming grain and grain products. It can infest corn, rice, and barley, but it is most commonly found in wheat and wheat-based products. Eggs are laid on the outside of the kernel. The newly hatched, ﬁrst-instar larva bores into the kernel, often following cracks and imperfections in the kernel surface. Under standard laboratory conditions, development from egg to adult can occur in 3 weeks. Adults are long-lived (4–5 months) and are strong ﬂiers. 3. Angoumois Grain Moth The adult Angoumois grain moth is a small, buff-colored insect with a wingspan of about 0.125 cm. Its most distinctive identiﬁcation features are the long hairs on the fore- and hind wings that give the wings a fringed appearance. Eggs, laid on or near grain, hatch about 1 week later. Larvae bore into the kernels where they feed and develop. Pupation occurs within the kernels. Adults emerge in about 2 weeks. Larvae produce a characteristic webbing on the food materials. Preferred foods include corn, barley, rye, oats, and rice. Adults do not feed on grain or other food products, thus do not cause damage. Larvae can occasionally be found developing in caked material. It is important, therefore, to thoroughly clean food processing areas and equipment. Pheromone traps are very effective for monitoring adult male populations. B. External Feeders 1. Indianmeal Moth The adult Indianmeal moth has a wingspan of about 0.125 cm. The copper-colored band of scales on the distal three-ﬁfths of the forewings makes this species easy to identify. The short-lived adults (5–7 days) are most active at dusk. Mating occurs shortly after adult emergence. The eggs are laid on food or food packages. The larvae feed on most grain-based products but also on chocolate, beans, spices, cocoa, nuts, and dried fruit. Larvae leave webbing behind as they feed, often causing particles of dry food to clump. The webbing, which often contains frass (feces), can contaminate food and bind equipment such as motors and augers. The combination of webbing and food is very attractive as an oviposition site [6]. Thus, webbing removal is an important measure to © 2003 by Marcel Dekker, Inc.

take to reduce future infestations. Mature larvae wander away from the food source looking for a place to pupate. Their natural instinct is to crawl up vertical surfaces, making observation of this insect pest easier than it is for many other pests. Trailing larvae can be used to identify an emerging pest population or locate an existing population. Adult male populations can be effectively monitored using pheromone traps. One characteristic of this insect, and also many other stored-product moths, is the ability to diapause (a period of slowed or suspended growth or dormancy). Diapause can be initiated in response to cold temperatures, high population levels, or short photoperiod [7,8]. Usually, the last larval instar is the one that diapauses, resulting in a ﬂush of adult emergence shortly after diapause terminates. Thus, an unheated warehouse that cools during the winter may give the appearance that control has been achieved, when in fact the larval population has diapaused and will resume activity when environmental conditions favor growth, typically in the spring. 2. Mediterranean Flour Moth The wingspan of the adult Mediterranean ﬂour moth approaches 2.5 cm. The forewings are a pale gray with transverse black lines and ﬂecks; the hind wings are gray to dirty white. At rest, this moth pushes up with the front legs, giving the body a sloped appearance. Lifespan and biology, including diapause, are similar to the Indianmeal moth. Pheromone trapping is very effective in monitoring this insect. 3. Flour Beetles Adult red ﬂour beetles and confused ﬂour beetles measure 0.3 to 0.5 cm in length. These two kinds of reddish-brown beetles are probably the most common and widespread, as well as the most important economically, of the food pests. They are also nearly identical, hence the ‘‘confused’’ in the common name. Probably the best identifying characteristics are seen in the antennae. Each antenna of the red ﬂour beetle ends abruptly in a threesegmented club, while the antennae of the confused ﬂour beetle gradually enlarge. Another morphological character that can be used to distinguish the two species is that the sides of the red ﬂour beetle’s thorax are curved; the sides of the confused ﬂour beetle’s thorax are nearly straight. A behavioral characteristic that can be used to differentiate red from confused ﬂour beetles is ﬂight ability. Red ﬂour beetles ﬂy (but are not strong ﬂyers); confused ﬂour beetles do not ﬂy. As with all food pests, this kind of information becomes very important when attempting to locate sources of infestation and existing infestations. In the case of those arthropod pests that do not ﬂy, it can be postulated that human activities must play some signiﬁcant role in moving these rather sedentary pests from one location to another. To determine where additional infestations may be found or where the source of an existing infestation is located, follow the product ﬂow. If an insect has ﬂight ability, it can readily move, perhaps from an adjacent room or even from a point outside the food manufacturing plant, to wherever there is available food. It may be understood, then, that locating the source of these highly mobile pests may be very difﬁcult and may require considerably more time and labor than might be the case for nonﬂying pests. Red and confused ﬂour beetles are major pests of ﬂour. Since they cannot feed on whole grains, they rely on other insects or rodents to ﬁrst damage the kernels. Flour beetles may be found in grain ﬁnes, dried fruit, chocolate, spices, rodent baits, botanical drugs, peas, beans, vegetables, dried milk, peanuts, cacao, and forest products. Eggs are laid directly on the product or packaging. Larvae are fairly active, but negatively phototactic, © 2003 by Marcel Dekker, Inc.

so observing them is difﬁcult. Pupae are naked (without any protection such as a cocoon or pupal case), and pupation usually occurs near the surface of the food or in a nearby sheltered place. Adults are attracted to light but have limited mobility to reach light traps, especially in the case of the confused ﬂour beetle. Both species are capable of breeding year round in heated buildings. In unheated buildings, only the adults are likely to be observed during cold weather. The confused ﬂour beetle is more common in the cooler parts of the world, while the red ﬂour beetle is more prevalent in warmer climates. However, given the worldwide trade in food products and raw ingredients, both species have become widely distributed, and it has been observed that both species can sustain populations in any geographic location. Eggs are laid in groups of twos or threes in the food material. Oviposition periods are longer for the confused ﬂour beetle (8 months versus 5 to 6 months) than the red ﬂour beetle. The life cycle from egg to adult may take about 7 weeks in the typical storage environment. Adults are very long lived, some over 3 years, and eggs may be laid for more than 1 year. Thus, considering the longevity and fecundity of these two ﬂour beetles, it may be understood why persistence is so important in managing these insects. When large beetle populations are present, both species can give ﬂour and other processed foods a grayish tint. Compounding the problem is the fact that this graying promotes the growth of molds that further contaminate the product. Additionally, both species produce secretions that impart foul odors to the food products. 4. Drugstore Beetle The adult drugstore beetle is a small (0.16–0.35 cm), light brown to red-brown, humpbacked beetle with the head not visible from above. The wing covers have pits arranged in longitudinal rows or grooves. Antennae have a three-segmented club. This beetle and the cigarette beetle, both members of the family Anobiidae, could both be confused with many wood-boring beetles. If the suspect, anobiid-like insect is found around food, it is most likely a drugstore beetle or a cigarette beetle. If wooden pallets are present and food residues are absent, identiﬁcation should focus on some sort of wood-boring beetle. The drugstore beetle larva is capable of feeding on a whole kernel of grain, but it prefers processed grain products. Drugstore beetle larvae can also feed on leather, wool, and other textiles, botanical drugs, spices, and tobacco. The adults do not feed [9]. Females lay eggs singly in cracks or folds of food or packaging. Newly hatched larvae are negatively phototactic and will actively seek access to food through minute holes in packaging. Larvae can perforate tin foil and sheet lead; thus many kinds of packaging are readily penetrated. From egg to adult takes 40 days under ideal conditions (30°C, 60–90% rh) [10]. Adults can live up to 3 months, but the usual adult lifespan is 2–3 weeks. Drugstore beetle adults are excellent ﬂyers and are attracted to light. 5. Cigarette Beetle The adult cigarette beetle (0.16–0.35 cm in length), a light brown insect with a humped shape, is similar in appearance to the drugstore beetle, but it has smooth wing covers and the antennae are sawlike. Eggs are laid in or near food. A complete life cycle, egg to egg, takes 30–90 days, depending on the temperature and other inﬂuences. Larvae avoid light, preferring to stay sheltered within the food source. After completing metamorphosis, the adults often remain inside the pupal chamber for about 1 week. They mate shortly after emergence. Adults live approximately 3 weeks. Although a major pest of tobacco, they also feed on grain products, dried fruits and vegetables, textiles, botanical drugs, spices, © 2003 by Marcel Dekker, Inc.

dried ﬂowers, and books. This insect is also an excellent package penetrator and a strong ﬂyer. Flight activity peaks in the late afternoon and early evening. 6. Grain Beetles Adults (0.3 cm in length) of the sawtoothed grain beetle and the merchant grain beetle are very similar in appearance to each other but can be easily distinguished from other food pest insects by the six sawlike projections on each side of the prothorax. To distinguish the sawtoothed grain beetle from the merchant grain beetle, examine the area around the eyes. The sawtoothed grain beetle has smaller eyes and the area just behind the eyes is much larger (see illustrations in the references cited in Section VII). Another important distinction is that the sawtoothed grain beetle does not ﬂy; the merchant grain is a weak ﬂyer. The life history strategies of the two species are very similar. Egg-to-egg development time requires 30–50 days. Females lay eggs singly or in very small batches in crevices in or around a food source. Larvae are very active and readily move about the food as they feed. Common food sources include ﬂour, cereals, and most other grain products; chocolate; pasta; dried fruits; nuts; dried meats; and sugar. Larvae supplement their diet by feeding on the eggs and dead adults of stored-product moths. Pupation occurs within the food in a very crude cell. Adults emerge within 7 days and oviposition usually begins with the ﬁrst day of adult life. Adults usually live 6–10 months; however, they have been known to live 2–3 years. Since adult sawtoothed and merchant grain beetles are not attracted to light, light traps are not effective monitoring tools. Sanitation is critical in controlling these pest species. Plant managers should be aggressive when implementing control strategies. The sawlike teeth of the pupal stage contain a foul-tasting repellent, apparently a defense mechanism. If large populations are allowed to build within a food ingredient, the resulting food product will have an offﬂavor unappealing to human tastes. 7. Other Grain Beetles Adult ﬂat grain beetles and rusty grain beetles, both 0.15 cm in length, are among the smallest grain-infesting beetles. Both can be distinguished from other ﬂat grain beetles by the presence of a raised line parallel to the outer margin of the thorax. It is very difﬁcult to distinguish these two beetles from each other. Male ﬂat grain beetles have very long antennae (about as long as the beetle’s body). Female ﬂat grain beetles and both sexes of the rusty grain beetle have short antennae. Both species are cosmopolitan, but the geographic range of the ﬂat grain beetle is restricted by low temperature and low humidity. The rusty grain beetle is the more abundant of the two in the wet tropics [10]. Both species feed on a wide variety of grain and food products. In general, mold growth ﬂavors larval development. Although incapable of feeding on perfectly intact kernels, those with even the smallest cracks or defects are vulnerable to attack. The larvae are also known to feed on dead insects. The life cycles of these two pests are very similar and they are often found together. Females lay their eggs singly in grain kernel furrows, grain debris, or processed product. Larvae appear in 8–10 days and spend their time actively moving about on the food. Pupation occurs within a cocoon made of food particles. Adults remain within the cocoon for a few days before chewing their way out. The life cycle can be completed within 1 month; however, under extreme conditions, this may take up to 3 months. Adults and larvae are cannibalistic on eggs, larvae, and pupae of their own species. Both species are © 2003 by Marcel Dekker, Inc.

capable of ﬂight. Spilled grain outdoors is a suitable breeding medium. From such outside habitats, the beetles readily ﬂy into food processing plants. 8. Dermestid Beetles There are several members of the genus Trogoderma in the family Dermestidae that are serious pests of stored products. Two species commonly found are the warehouse beetle and the cabinet beetle, adults of both measuring 0.3 to 0.6 cm in length (adult size is dependent on the size of the larva at the beginning of pupation). It is very difﬁcult to identify these insects at the species level. This task usually requires the expertise of an entomologist trained in the taxonomy of this family. However, some characteristics can be used to identify members of the genus Trogoderma. These are small, oval-shaped beetles, basically dark colored but with the wing covers having a variety of brown and yellowish scale patterns. Trogoderma larvae can be distinguished from other dermestid larvae in that they grow to about 0.6 cm (compared to 1.4 cm for black carpet beetles) and are a yellowish-tan color that is lighter than black carpet beetle larvae. Several long thin setae (hairs) extend out from the tip of the abdomen, and rings of hair encircle the entire body in distinct segments. In the United States, Trogoderma beetles are not so important as pests as they are in those countries where the most important pest dermestid, the khapra beetle, occurs. This beetle is the most destructive pest of stored food and is the only insect the food industry confronts that is under quarantine status. When an infestation of khapra beetle is discovered within the borders of the United States, the U.S. Department of Agriculture takes immediate effective measures to prevent the spread of this pest to adjacent areas. Trogoderma larvae, more speciﬁcally their setae, or hairs, are an important health concern, and infestations will certainly get serious attention from health and food regulatory ofﬁcials [2]. Trogoderma larvae have two types of setae. One type, the hastiseta, has numerous barbs on the end of the shaft, while the other type, spiciseta, is slender with numerous pointed hairs. Both types are present in the cast skins left behind after a larval molt and can be found in food products infested with Trogoderma larvae. If consumed, the barbs and sharp hairs can be irritating to the mouth, esophagus, and other parts of the digestive tract. This can be especially dangerous to infants and young children. Therefore, it is important to take immediate action when this pest is detected within a food processing facility. The cabinet beetle is capable of infesting a wide variety of materials of both plant and animal origin; however, it does best on processed cereals and animal feeds. Warehouse beetle populations increase the fastest on animal feeds, barley, wheat, pollen, and grocery products such as oatmeal, wheat germ and whole wheat ﬂour. However, it can sustain populations on cocoa, ﬁshmeal, nuts, dried peas, candy, pastas, spices, dead animals, and dead insects. 9. Spider Beetles The various kinds of adult spider beetles are so named due to their very small head and prothorax and large abdomen, causing some species to resemble spiders. They range in length from 0.078 to 0.469 cm and have long hairy legs that also make them look spiderlike. Spider beetles in the genus Ptinus are more prevalent in colder climates, preferring temperatures of 25°C or less. Thus, Ptinus species can often be found in unheated warehouses and plants, typically older wooden facilities with damp basements. Eggs are laid in or on the larval food. After three larval molts, the larvae bore into old wood, food © 2003 by Marcel Dekker, Inc.

packaging, or cardboard, where pupation occurs. Development times vary with each species: Australian spider beetle: 3 months; brown spider beetle: 6–9 months; whitemarked spider beetle: 1 month [11]. Spider beetles are scavengers that can be found feeding on milled or processed grains, dried fruits, dried meats, textiles, animal droppings, and dead insects and vertebrates. Animal nests are a favorite habitat where they ingest moist animal excreta. They thrive in dark, moist cracks where spilled food materials accumulate. Since they prefer the dark, they are most active at night. Spider beetles can remain active during freezing temperatures, thus pest problems are possible year round in unheated facilities. Inspecting for spider beetles is not like inspecting for most other stored-product pests. The search area should be expanded to include suspected rodent, bird, bee, and wasp nests; textiles; animal carcasses; and any hidden areas where grain dust could accumulate (ﬂoor cracks, wall voids, false ceilings). Caution should be taken when cleaning up these infestations, since there is a risk of contamination by pathogens present in rodent urine. Sealed (nonvented) eye goggles, protective gloves, and a respirator with a HEPA ﬁlter (contact public health ofﬁcials for speciﬁc requirements) should be worn. Spider beetle infestations are very difﬁcult to manage because the beetles are active mainly at night and feed on a wide variety of materials. Sanitation and sealing are key management strategies. 10. Mealworms People that ﬁsh or have reptilian pets are familiar with the immature stage of these two food pests, the yellow mealworm and the dark mealworm, since they are commonly used as bait and pet food. However, most consumers are unaware that the adults of these two species are among the largest beetles (length 1.25 cm) closely associated with the food industry. They may be confused with ground beetles, insects that occasionally invade buildings. Since they are in the same family as the ﬂour beetles, they may be incorrectly identiﬁed as ‘‘large’’ ﬂour beetles. Adult mealworms are oval in shape, more ﬂattened than ground beetles, have eleven-segmented antennae (ﬁliform or moniliform) and a 5– 5–4 tarsal formula (ground beetles have a 5–5–5 tarsal formula). Dark mealworms are dull black; yellow mealworms are shiny dark brown to black. Mealworms overwinter as larvae, emerging as adults the following spring to mate and lay eggs. Adult females live 2–3 months and oviposit intermittently as long as they live. They prefer old, moldy, out-of-condition grains or grain products, but will feed on cereals, crackers, and meat. The larvae (length 3.125 cm) can survive long periods of time (6–9 months) without food or moisture. Poor sanitary conditions with ample moisture are conducive to population outbreaks. The presence of mealworms within a food facility is cause for concern. Ingestion of mealworm eggs can cause severe gastrointestinal upsets. Mealworms are produced for human consumption and are served in restaurants around the world. The strong-ﬂying adults are attracted to lights. C.

Structure-Infesting Pests

1. Cockroaches Cockroaches used to be the primary pests of structures, including food processing plants. However, with the development of effective baits for population suppression, cockroaches have declined in relative importance to other pests. This is not to say that they are not important pests. Cockroaches have a close association with humans and commonly feed on human foods, but they also often feed in unsanitary areas such as sewerage systems.

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This connection between cockroaches and unsanitary habitats has led to the speculation that they have the potential to transmit disease organisms to humans. Pathogenic organisms, including bacteria, fungi, protozoans, viruses, and molds have been found on cockroaches. However, while only circumstantial evidence is available that directly points to cockroaches as vectors of human disease, this evidence is compelling [5,12–14]. a. German Cockroach. The German cockroach (length 1.6 cm) is a common pest in food processing plants. It is easily identiﬁed by two dark longitudinal stripes on the pronotum. The body is brown, females being slightly darker than males. Indoors, this insect can breed year round. German cockroaches produce more eggs per egg capsule and the immature stages complete their growth faster than any other cockroach species. Egg-toadult development can be completed in just over a month, although 2–3 months is more common. Females carry the egg capsule until the eggs are just ready to hatch. This behavior increases the survival rate of young German cockroaches by preventing egg capsule mortality factors. The number of eggs per capsule is usually 30–40. Adults live 3–6 months. Rarely found outdoors, German cockroaches inhabit structures where food, water, and harborage are available. They will feed on all types of human foods and also on glue, toothpaste, soap, and many other organic materials. b. American Cockroach. American cockroaches are very large roaches (3.75–5.3 cm in length), red-brown in color, with fully developed wings that completely cover the abdomen. The pronotum has a dirty-yellow band around the margin. Egg capsules are either dropped at random or glued to surfaces in protected locations. The nymphal stage lasts for more than 1 year, sometimes 2 years. Wing pads become evident in the third or fourth instar. Adult females live about 1 year, while males live only 6–9 months. Females can produce egg capsules at very short intervals (every 4 days during the summer) and are able to produce viable egg capsules without mating [13]. American cockroaches prefer warm, damp locations. Steam tunnels, sewer lines, and boiler rooms are common sites. They are strong ﬂyers and easily migrate into buildings. c. Brown Cockroach. This red-brown cockroach (length 3.1–3.8 cm) looks very similar to the American cockroach except the American cockroach is typically much larger and the cerci (antenna-like projections at the rear of the abdomen) are triangular in shape and less than twice as long as they are wide. The pronotum has a faint dirty-yellow band around the edge. It has fully developed wings and can easily migrate into structures. It usually is found in warm, damp locations (steam rooms, boiler rooms, steam tunnels); however, during the summer, brown roaches can be found in large numbers outdoors. It is more common in the southern United States, and although its distribution is probably widening, misidentiﬁcations may explain some reports of its presence in northern climates. Like the American cockroach, the egg capsules are either dropped randomly or glued near the ceilings or elevated sites. Egg capsules generally have 25 eggs. Nymphs emerge in about 35 days. Egg-to-adult development takes on average 200 days. Adults are long lived (8–9 months). d. Brownbanded Cockroach. Brownbanded cockroaches (length 1.25 cm) are lightbrown to brown and have two light yellow-brown bands running across their wings (when the wings are at rest across the back), and there is a light area on either side of the pronotum. Females are darker and their wings cover only three-fourths of the abdomen. Egg capsules (containing about 15 eggs) are carried by the female for 1–2 days, then attached to a secluded surface. Nymphs appear in about 2 months and do not become adults for 3– 10 months, depending on environmental conditions. Adults live approximately 6 months.

© 2003 by Marcel Dekker, Inc.

Brown-banded cockroaches prefer a drier environment than most cockroaches and prefer to hide in elevated areas above the ground ﬂoor. e. Oriental Cockroach. The Oriental cockroach, a medium-sized blattid (male length 2.5 cm; female 3 cm) is very dark brown to black. Males have fully developed wings, but apparently do not ﬂy. Females have rudimentary wings that appear as wing buds. Thus, females are often confused with nymphs but can be distinguished from the nymphs by the presence of wing venation. Females carry the egg capsule containing about 16 eggs for 1–5 days before depositing it in a sheltered location near food. Nymphs emerge about 2 months later. Depending on environmental conditions, development to adult may take 9 months to more than 2 years. Adult females live 1–6 months, while males live 3–5 months. Oriental cockroaches are often abundant in commercial facilities. They are often found in damp locations (drains, crawlspaces, sewer lines) but can also be found outside in leaf litter, mulch, and trash. They prefer starchy foods, but they will feed on almost any kind of organic matter. 2. Psocids Psocids, commonly called booklice (but are neither lice nor mites, though often mistakenly identiﬁed as such), are small (length 0.078–0.625 cm), colorless to gray or light brown insects with scalelike wings (usually nonfunctional). Psocids undergo gradual metamorphosis, typically reaching adulthood within 1–2 months. Adults survive 1–3 months. Many species are able to reproduce without mating (parthenogenesis). Psocids prefer damp, warm, undisturbed conditions. Dry conditions or low humidity either stops or slows development or causes desiccation and death. Psocids feed primarily on molds, so any product that can sustain mold growth can harbor a psocid population. They can also feed on starches, starchy glues used in bookbindings, and dead insects. Raw grain to ﬁnished food products and everything in between are vulnerable if the materials become moldy or are stored under humid conditions. The most common complaint in warehouse situations is the presence of psocid populations on wooden pallets that have been stored outside in the rain or on cardboard boxes that have been stored under high moisture conditions. During hot humid weather, psocid populations often build up on composite ﬁber ‘‘slipsheets’’ used to separate palletized stacks of newly manufactured metal cans. Unless the cans are thoroughly sanitized before foods are put into them, some insects will be canned with the product. Switching to plastic slipsheets and plastic pallets effectively eliminates psocid problems in this segment of the food manufacturing industry. The easiest way to prevent or eliminate psocid infestations is to reduce the relative humidity to less than 50% and increase air movement to aid in moisture evaporation. If moldy conditions exist, equipment, walls, and ﬂoors should be cleaned with a disinfectant to remove the mold and then dried thoroughly. Although psocids are troublesome in that they contaminate food products by their presence, they usually cause little direct damage to bulk grains. 3. Flies There are numerous species of ﬂies that are very well adapted to living in and around humans. Unfortunately, ﬂies, like cockroaches, are capable of carrying disease-causing organisms [4,5]. Public health and federal inspection ofﬁcials always take note of ﬂy © 2003 by Marcel Dekker, Inc.

infestations during inspections. Identiﬁcation of the breeding source is critical to managing ﬂy infestations. Without the proper identiﬁcation of the ﬂy species, the breeding source may not be correctly identiﬁed. Adult ﬂies can be easily separated from other insects in that they only have one pair of wings; each rear wing is represented by a small appendage called a haltere. Immature ﬂies (maggots) do not have legs. To facilitate this discussion, three arbitrary categories of ﬂies are considered here: small ﬂies, ﬁlth ﬂies, and nuisance ﬂies. a. Small Flies drosophilid fruit flies. Several different species lumped together under the common name of fruit ﬂies or vinegar ﬂies are among the most common kinds of ﬂies in wet processing facilities where breeding occurs in decaying, moist organic matter. In the case of those species with red or purple eyes, this distinctive eye color rules out identiﬁcation as a phorid ﬂy. Adult fruit ﬂies have a tan-colored body and are usually about 0.3 cm in total length. Larvae are creamy white with a breathing tube at the rear end. The brown-colored pupae bear distinctive hornlike stalks at one end. Eggs are deposited on or near the surface of decaying organic matter. Females lay up to 500 eggs that hatch within 1–2 days. Larvae feed for only 5–6 days and then crawl to a drier area for pupation. Under ideal conditions, the egg-to-adult cycle can occur in 8 days. Thus, populations can quickly build to tremendous numbers. Sanitation and moisture control are critical to limiting population growth. Minimal food is needed to complete the cycle. These ﬂies can complete their life cycle with the organic matter and moisture found in a damp mop. Garbage cans without liners are also suspect. Light trapping is effective with recently emerged adults but is not a substitute for sanitation. phorid flies. Adult phorid ﬂies (length 0.3 cm) are similar in size and appearance to the fruit ﬂy. However, they have a humpback-shaped thorax and lack red eyes. Phorid ﬂy wings also have two heavily sceloritized (dark) veins near the forward edge of the wings. When disturbed, the adults tend to run for a short distance before taking ﬂight. The females have a brown, saddle-shaped segment near the end of the abdomen. Pupae lack the two horns found on fruit ﬂy pupae. This clue would be helpful in making an identiﬁcation if no adult ﬂies were available. Like the fruit ﬂies, phorids feed on and breed in moist organic matter. They are a major concern in hospitals or long-term health care facilities where they sometimes infest open wounds of patients. Eggs are laid one at a time in groups of 20 to 40 over a 0.5-day period. The larvae emerge in 24 hr and feed for 1–2 weeks, depending on temperature. The larvae will crawl to a drier location to pupate. Egg-to-adult development can take from 2–4 weeks. moth flies. Often confused with moths because of their scaly wings, these ﬂies are major pests of processing facilities, where they breed in drains and thus come into contact with bacteria. The adults are yellowish, brownish-gray, or black and are about 0.3 cm in length. When resting, they hold their mothlike, hairy wings rooﬂike over the back. Eggs are typically laid in the gelatinous ﬁlm inside a drain or in decaying organic matter. The larvae hatch within 2 days and feed for 2 weeks on drain sludge, bacteria, fungi, and algae. Larval breathing is accomplished by extending a segmented breathing tube to the surface. The pupal stage is short, about 1.5 days. Adults live 2 weeks and can often be found resting on the walls of bathrooms. They are weak ﬂyers, thus are usually found near the breeding site. Adults become active at night, hovering close to the breeding site. Adults feed on pollen or polluted water. © 2003 by Marcel Dekker, Inc.

Moth ﬂies in a facility indicate that they are either breeding within the facility or in nearby sewage or water-treatment facilities. Drains should be scrubbed clean all the way to the trap. If the source cannot be found in the drains, look for cracks in the slab. Often pipes beneath the slab will break, depositing moist organic matter and allowing breeding to occur out of sight. To conﬁrm a breeding site, wait until dusk and then cover the crack with tape or a plastic bag with double-sided tape inside. Check the tape for ﬂies in the morning. Since adults are active at night, some will likely get caught on the tape. b.

Filth Flies

houseflies. The most common ﬂy worldwide, the houseﬂy, is a medium-sized (0.3–0.6 cm long), gray ﬂy with four dark stripes on the back of the thorax. It is often confused with the face ﬂy. To separate the two kinds of ﬂies, examine the calypter: bare with no tuft of hairs—houseﬂy; tuft of hairs present at point of attachment to the thorax— face ﬂy. Eggs are laid in groups of 75 to 150 in moist organic matter, typically animal feces. Eggs hatch in about 1 day, and the larvae will then burrow deep within the food medium. They can pupate within 3 days, although a week or two is not unknown. The adults feed on the same food as the larvae and can be found sampling most human foods. Adults typically feed on liquids, but can also feed on solids by regurgitating digestive ﬂuids onto the food. This regurgitated product dissolves the food enough that the mouthparts can sponge up the mixture. Adults are strong ﬂiers, able to ﬂy up to 20 miles, although 1–2 miles is more common. Adults, when not active during the day, prefer to rest low (less than 1.5 m) on vertical surfaces. During the night, they may rest at greater heights. Because the adults are attracted to lights, the use of properly installed light traps can decrease the risk of pest invasion from outdoors. Trash should be stored away from any entrances to the facility and removed on a regular basis (at least weekly). blow flies and bottleflies. Several species of blow ﬂies or bottleﬂies (length 0.6–1.25 cm) have been known to infest buildings where food in manufactured. These ﬂies are very important agents in the natural decomposition of dead animals, often being the ﬁrst insects to lay eggs on such substrates. Forensic entomologists are often able to set the time of death by examining the size and type of maggots present on a human corpse. If a carcass is not available, the ﬂies seek out garbage or other decaying organic matter, including feces, on which to oviposit. The larvae burrow within the carcass to feed, but crawl away from it and then burrow into the soil to pupate. These ﬂies overwinter in either the larval or pupal stage. The adult ﬂies are easily identiﬁed by the metallic blue, green, blue-green, or yellowbrown sheen of their bodies. The adults are very active during the day, often buzzing around windows, doors, and oviposition sites. At night, inspection of suspected breeding areas may reveal adults resting nearby. The presence of these ﬂies may indicate that an animal has died within the structure, possibly in the walls or attic, or in a multiple-catch rodent trap that was not promptly serviced. c. Nuisance Flies cluster flies. Cluster ﬂies (adult length 0.93 cm) are closely related to blow ﬂies (same family) but are closer in size to house ﬂies. The nonmetallic gray body lacks thoracic stripes. Golden hairs, easily seen with 30⫻ hand lens, are situated on the thorax right behind the head and around the base of the wings. When viewed from above, the body appears to be narrow, due to the wings completely overlapping the back. When crushed, adults smell like buckwheat honey.

© 2003 by Marcel Dekker, Inc.

Unlike most ﬂies that appear in food facilities, cluster ﬂies do not feed on decaying organic matter. Instead, larvae are parasites of earthworms. Eggs are laid singly in soil cracks. Eggs hatch in 3 days and the newly emerged larvae seek out earthworms. The larvae burrow into an earthworm and feed for about three weeks. Egg-to-adult development typically takes 1–1.5 months. During most of the year, cluster ﬂies are not a problem. They become a nuisance with the onset of cooler weather when the adults enter structures in large numbers seeking overwintering sites. The adults are attracted to light-colored south and west walls that radiate heat on cool nights. Once they gain access to the structure, they crawl into small cracks. Unseasonably warm weather causes overwintering adults to become active. Since they are seeking warmth and attracted to light, they are usually found on windowsills or in light traps. Since cluster ﬂies breed in earthworms, there are no practical methods to control this pest at the breeding site. Emphasis must be placed on sealing structures so that the ﬂies cannot gain entrance in the fall. Insecticidal treatment of exterior surfaces, where adults rest before entering structures, can reduce the numbers that eventually gain access to the structure. Timing of these treatments is critical and dependent on local weather conditions. D. Noninsect Pests—Mites Both the grain mite and the cheese mite (length of both 0.039 cm) are much smaller than most adult ticks and, in fact, are barely visible to the naked eye. Mites have an unsegmented abdomen broadly attached to the thorax. Adults and nymphs have eight legs, larvae have six. Mites are very difﬁcult to identify to species except under high magniﬁcation. Grain mites are largely transparent, with tan mouthparts and legs; cheese mites are pearly white, with yellow to red-brown legs. Mites are very common in cereals, dried fruits, cheese, and most stored foods. Heavily infested food, which deteriorates rapidly due to the presence of dead and live mites as well as their fecal material, has a characteristic sweet or minty odor that is easily detected by the human nose. Infested product may also be coated with ‘‘mite dust’’ composed of molted skins. Contact with some mites can cause a skin condition known as baker’s itch or grocer’s itch. Like psocids, mites require a minimum relative humidity of about 62%; below this the population will die out [15]. Infestations occur more often when products are produced or stored under cool, humid conditions. Eggs, deposited directly in the food material, hatch into six-legged larvae in 3–4 days, and those larvae feed for 3 days before going quiescent for a few days. Nymphs then transform into adults about 3 weeks later. Adults live 40 days. Grain mites have a nymphal resting phase (hypopus) that does not feed but can attach to other animals (birds, rodents, insects), resulting in an increased chance for dispersal to new food sources. Effective management strategies include keeping the relative humidity below 60%, reducing moisture, and increasing air ﬂow.

III. NONCHEMICAL METHODS FOR MANAGING FOOD INDUSTRY PESTS A. Exclusion The best way to prevent an infestation of insects and mites inside a building is to prevent them from getting inside. The easiest way to do this is to keep all doors and windows closed and well sealed. Brush seals and weather stripping should be in good shape. If

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spring-loaded return mechanisms are installed, they should be in good working order and properly set so that doors close completely. If doors need to be kept open, then tightﬁtting screens should be installed. Screens should receive regular maintenance to repair holes. Mesh should be as small as possible to prevent insect entry but still allow for adequate air ﬂow. Exclusion of most ﬂies can be accomplished with 14*18 or 16*16 mesh screen. Air doors (or curtains or screens) are devices that are mounted over a doorway that force a powerful stream of air downward to keep insects from entering while the door is open. The problems with these devices are twofold. First, if installed above an exterior door, changing air pressures on the exterior of the building may either pull the air stream outside or push the air stream inward, carrying insects into the facility. To correct this, air doors should only be used on interior doors to keep insects from penetrating further into a facility. The second problem is that the mechanism is usually improperly adjusted so that the stream of air is not strong enough to prevent insect penetration. A ventilation engineer should be consulted to conﬁrm the proper installation and maintenance of these barriers. B.

Lighting and Trapping

1. Lighting for People Lighting is one of the most important factors to be considered when the objective is to minimize problems with nocturnal ﬂying insects and stored-product pests that are attracted to light. Two factors must be considered when lighting the exterior of a facility: bulb type and ﬁxture placement. Bulbs vary in their ability to attract insects; using the proper bulb in the correct situation will result in the desired insect response. Mercury vapor bulbs are most attractive to insects, while sodium vapor bulbs are least attractive. When installing lights on the outside of a facility, mercury vapor bulbs should be used on the perimeter of the facility grounds and parking lots. By using mercury vapor bulbs away from the facility, any insect that is attracted to light will be drawn away from the facility. If lighting is needed near the facility, sodium vapor bulbs should be used. Sodium vapor bulbs have a pink, yellow, or orange glow that is much less attractive to insects than light in the bright white or bluish spectrum. Indirect lighting should be used whenever possible on or near a facility, so that the actual light source is shielded from direct view. If insects come to rest on the building exterior, there is a greater chance that they will be drawn into the facility when the doors are opened. Treatment of exterior walls of the facility with a residual insecticide will most likely not control the problem. Insects that are attracted to light are generally capable of ﬂying long distances. Therefore, those insects killed by a residual chemical treatment will most likely be quickly replaced by new arrivals. The best way to light a facility for pest prevention is to mount light ﬁxtures a considerable distance from the facility so that the light shines on the building, but the bulb is not near the building. Thus, insects that are attracted to the light do not come to rest on or near the building. 2. Light Traps and Modiﬁed Light Traps a. Light Traps. Light traps can also be used within the facility to monitor pest populations and to prevent insects from gaining deeper access inside a facility. Light traps should be used when the potential for insect infestation (especially ﬂying insects) is greatest. © 2003 by Marcel Dekker, Inc.

Since devices designed for home use do not have the safety features required in food manufacturing plants, only commercial units should be used. Light traps used within a facility are most effective for nocturnal ﬂying insects. Flies, however, can be very slow to respond to light traps. Thus, plant managers should not rely on light traps to take the place of structural sealing and enforcement of a closeddoor policy. There are numerous different types and sizes of light traps available on the commercial market. They vary in the way in which they catch insects and how they deal with attracted insects. The ﬁrst traps on the market were electrocuting traps and these traps are still very popular. They use black light to attract the insects to the trap, where they contact an electric grid that delivers a usually fatal electric shock. Dead and stunned insects fall into a collection receptacle. It is very important to empty and clean these collection trays on a regular basis. Some food pests also readily feed on dead insects (for example, the warehouse beetle and other dermestids). If dead insects are allowed to accumulate in a trap, a secondary pest infestation will start within the light trap. When this food source is exhausted, insects will move to other locations within the facility, possibly to some previously uninfested product or processing area. b. Add Glue Boards. Some traps feature a glue board in the collection tray. Glue boards prevent whole insects or fragments of insects from being blown or jostled out of the trap, and they prevent recovered stunned insects from leaving the trap. Newer light trap models use a low voltage electric pulse to stun the insects, which then fall down onto the glue board. This reduces the production of insect fragments and does not create the bug zapping sound generated by the electrocution-type traps. The combination of a glue board and a black light (with no electric grid) is more acceptable for placement in public access areas of a plant. Insects attracted to the light become trapped on the glue board when attempting to rest near the light. Any light that uses a glue board is suitable only for areas of a facility with low insect activity and low dust production. 3. Trap Placement Placement of traps is critical to a successful program. If the target pest is a ﬂy, especially houseﬂies and other ﬁlth ﬂies, traps should be placed no more than 1.5 m above the ﬂoor. If night ﬂyers are the target, traps should be ceiling mounted but always in a location that will permit inspection and cleaning. Lights should not be placed where they can be seen from outside the building or where there is competition from other light sources. If light traps are needed near bay doors, they should be placed above the top of the doorway and perpendicular to the door so the light is not directed outside. Wall mounted traps should also not be placed where visible from the exterior of the facility. Do not install electric light traps outside, especially near the loading dock. They will only attract more insects than they can catch. There is, however, one effective way to use traps designed for outdoor installation, and that is for those food manufacturing facilities situated near large bodies of water (lakes, rivers). Light traps can be placed away (at least 9 m) from the building facing the facility (back of trap toward water). Insects that are attracted to the lighted building will be pulled back toward the water and away from the structure. Never install light traps at ceiling level, directly over, or next to food production, food handling, or food processing areas of a facility. This will attract more insects to the © 2003 by Marcel Dekker, Inc.

site and there is a risk for insect fragment contamination. Do not install light traps within 4 m of an entry door. Insects will easily pass between the light trap and the entrance to the facility and gain ready access without trap interception. Finally, do not place traps where they can easily be damaged by forklifts or where there are strong air currents. 4. Trap Maintenance Maintenance of light traps is crucial to program effectiveness. Annual replacement of bulbs is mandatory, even if the bulb still appears to be bright. The older the bulb, the less attractive it is to insects. The best time to replace the bulb is in the spring, so traps are most effective during the time of the year when insect pressure is the greatest.

IV. MONITORING WITH PHEROMONE TRAPS A.

Pheromones

Insects, like all animals, live in a world abounding with odors. These odors ﬁll the air, coat the surfaces of plants, and emanate from food sources. Some chemicals released into the atmosphere serve as chemical messengers to other individuals of the same species. Such chemicals have been given a special name, pheromone (from the Greek pherein, to carry, and horman, to excite). Pheromones, then, are chemicals secreted by an animal that affect the behavior of other animals of the same species. Typically, each speciﬁc pheromone conveys a speciﬁc message to the recipient animal in which it prompts a speciﬁc behavior or a speciﬁc physiological modiﬁcation. For example, the sting-release pheromone, emitted when a honeybee pulls away from the animal it has stung, leaving its stinging apparatus stuck in the target host, ‘‘tells’’ nearby bees something like ‘‘Danger! Come help me!’’ Each kind of stored-food moth and beetle pest produces a rather large inventory of pheromones, each of which elicits a speciﬁc behavioral response or, in some instances, a range of behavioral responses in other members of the same species that happen to be situated within the range of inﬂuence of that particular pheromone. At low population densities, ﬂour beetles, for example, aggregate in response to the secretion of quinones; at intermediate densities they distribute randomly, and at high population densities they distribute themselves uniformly. Thus, not only does the chemical send a message, but also the interpretation of the message received varies depending on the condition of the receiver. Larvae of the Mediterranean ﬂour moth secrete compounds that also affect population dispersion. In crowded conditions, the responses include both behavioral and physiological components: dispersion, lengthening of the generation time, and lowering of the fecundity (egg-laying rate) of females. B.

Pheromone Traps

1. Aggregation Pheromones The most common pheromones used in trapping programs are aggregation and sex pheromones. Long-lived adult insects usually produce aggregation pheromones, while shortlived adults are more likely to produce sex pheromones. Aggregation pheromones, usually secreted by the male, are especially useful to food pest managers because they can cause a response in both males and females. © 2003 by Marcel Dekker, Inc.

The beetles that produce aggregation pheromones are typically long lived (⬎1 month) and must feed in order to reproduce. Thus, the aggregation pheromone not only signals the presence of food, but indicates that mates are available. Weevils (rice, maize, and granary) produce aggregation pheromones that are attractive to both sexes. Maximal production of this pheromone occurs when food is present. Since these beetles cannot survive for more than 1 week without food, the advantage of signaling both food and mate availability is obvious. 2. Sex Pheromones The most commonly used pheromones in trapping programs are the sex pheromones. They may be derived from either natural (collected from adults) or synthetic (produced in the laboratory through a series of chemical reactions) sources. Adults that produce sex pheromones are usually short lived (⬍1 month) and are able to successfully mate without feeding (they rely on nutrient reserves acquired during the larval stage). Though the pheromone is usually released by the female to attract males, sex pheromones may be produced, and responded to, by either sex. The chemical is usually released when the insect assumes a characteristic posture referred to as the ‘‘calling position.’’ In this position, the abdominal apex is elevated and the pheromone-secreting glands at the tip of the abdomen are extruded. Species that produce sex pheromones usually have a highly synchronized communication system involving daily activity rhythms that determine the time and pattern of pheromone release. For example, Indianmeal moths are generally active in the late evening, while Mediterranean ﬂour moths are active in the early morning. The concentration of the chemical released is very important in eliciting the correct response on the part of the receiver. At low concentrations, the receiver might respond by ﬂying toward the source; higher concentrations may elicit courtship and mating behaviors. Pest managers in many different types of food production and storage industries have found that pheromone traps can be very useful in determining the location and intensity of insect infestations. The use of pheromone traps for monitoring insect populations is now commonplace. Since insects are very sensitive to low concentrations of these chemicals, pheromone traps are excellent devices for discovering low population levels of adult insects. The pheromones of many of the major insect pests of the food industry have been identiﬁed and synthesized and can now be purchased from commercial suppliers. Also, the traps and food attractants that can be used simultaneously with pheromones have been improved and are readily available from commercial sources. To monitor with pheromones, small amounts of synthetic pheromone are placed within a lure (available in a variety of designs) that allows for slow release of the pheromone. The lure is then placed within one of several types of entrapment devices. An example of a successful monitoring program may be seen in the tobacco industry. This, of course, is not a food industry, but the principles illustrated may be applied to food facilities. The cigarette beetle is a major pest of stored and processed tobacco. Pheromone traps deployed throughout a cigarette factory are very effective for pinpointing cigarette beetle infestations. The advantages that pheromone traps provide to the industry over conventional methods are (1) they can be placed in processing equipment and in other areas likely to shelter insect populations, (2) they can compete with tobacco odors for the insect’s attention, (3) they do not require additional expense to operate (e.g., electricity for light traps), and (4) identiﬁcation and counting of the trapped insects are easier since only the target species is captured. © 2003 by Marcel Dekker, Inc.

3. Trap Placement There are no hard and fast rules about trap placement since each warehouse and food processing facility is different and each presents its own challenges. Placement of traps depends on the size of the building, availability of supporting posts, ﬂow of product, type of insect to be monitored, and the purpose of the monitoring effect. However, there are some guidelines that should be followed in all kinds of food production facilities. To minimize the attraction of insects from outside the facility, pheromone traps should be placed away from doors and open windows when insects are active outdoors. Of course, a management policy that allows the doors and windows of a food manufacturing plant to remain open is uninformed at best. Even when the windows are properly screened, sensitive insects will still respond to the pheromone scent and will therefore gather on the exterior of the building and, from that vantage point, some of them may gain access to the building interior in spite of all measures taken to exclude them. It may be useful to place traps outside the facility to capture insects before they can enter a building. Outdoor traps can also be used to monitor seasonal ﬂuctuations in the populations of the target insects. Timely discovery of pest problems outside a facility could well serve as a warning of potential problems inside a facility. If pheromone traps are to be placed on the outside of the facility, the weather conditions to which the trap will be exposed should be considered when choosing a plastic trap or a waxed cardboard trap. Inside the facility, the issue of dust can be important, especially if sticky-type traps are used. Glues used in aerial sticky traps are able to absorb some dust and still remain effective. However, where dust is a serious problem, wing and funnel traps can be adjusted to reduce the opening size. The addition of slotted side panels to rectangular beetle traps can increase trap longevity. Regardless of the type of trap deployed, traps should be checked more often in high dust situations to ensure that the glue remains effective. Foot and vehicular trafﬁc, as well as sanitation and maintenance activities, should certainly be taken into consideration when placing a trap. A trap that has been run over by a forklift is worthless for catching insects. Traps placed on the ﬂoor are prone to being swept up, crushed, or displaced under pallets. Wall placement of traps is, therefore, more likely to be the better option. Additionally, if traps are to be placed in areas that are prone to dampness or moisture migration (brick and concrete ﬂoors and walls, areas where leaks are common, or where hose washing is routine), select the plastic or wax-coated paper designs because they are more resistant to moisture damage. In situations where curious, unauthorized personnel are likely to tamper with the traps, the traps should be enclosed in tamper-proof metal cages. Traps should be placed in corners, near interior walls, and on supporting posts in grain bins. The speciﬁc location of a trap will depend on the type of trap and the insect pest to be monitored. The best locations are in areas where insects have been observed, in receiving areas, or in areas with high potential for reinfestation. Traps designed to capture crawling insects should be mounted on vertical surfaces 1 or 2 m above the ﬂoor; in other words, the trap should be located in such a position so as to facilitate access by crawling insects. For ﬂying insects (especially moths), the trap should be placed at or near ceiling height or, in the case of grain bulks, 2 or 3 m above the grain surface. Traps should be placed close to areas that collect food debris such as under equipment; near conveyors, ledges, closed storage areas, ﬁre extinguisher cabinets, wall lockers,

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electrical junction boxes, and motor guard units; and in areas where temperatures are warmer and humidity higher and where sanitation is difﬁcult. Speciﬁc label directions for each pheromone trap should be closely followed.

V.

MANAGEMENT INTERVENTIONS

There is considerable debate about when steps should be taken to correct an insect pest problem. Unfortunately, there is no magic number, formula, or chart that will spell out the level of action to be taken and when to take it (see also Chapter 20). In food storage and processing environments, the threshold for intervention is often the presence of just one insect. Management decisions based on detection alone assume that the probability of detection is directly related to insect density. But this is true only if the trapping program adequately covers the area that must be protected. It also assumes that pest biology, environment, trap design, and all the other factors discussed here have been correctly taken into account. Each of the several different kinds of stored-product insects responds in its own way to pheromones. For example, moths are more readily attracted than beetles, and short-lived beetles are more highly attracted than long-lived beetles. Thus, many factors must be taken into account when evaluating the story that trap records are telling. All records and associated notes should be carefully organized and ﬁled for future reference. Computer programs can be used to facilitate the summarizing of very large amounts of information. Trapping records can be useful in establishing or reﬁning quality assurance programs. The capture of one or a few insects in a trap usually signals the presence either of a small infestation or accidental entry of outdoor insects. Repeated catches over a longer period of time would indicate the likelihood of an ongoing infestation within the plant, while the consistent capture of large numbers of insects would very likely mean that a major infestation is in progress. If any pest insects happen to be present in a food manufacturing plant at the start of monitoring, the ﬁrst week of trapping will usually net a few of these insects. Data from subsequent weeks of trapping will yield a more precise indication of the origin of the problem. Further repeated intense trapping will usually pinpoint the problem area. Since there are no magic numbers, action levels (the points that trigger interventions) should be based on data collected and evaluated over the entire facility. Emphasis should not be placed on the total insects caught in the facility, but rather on the change in the number of insects trapped in each trap. Actions should be taken only if trap catches indicate population growth in one or more areas of the facility, no matter if from zero to one or 10 to 100. Absolute numbers will vary from facility to facility. Let trapping history be your guide.

VI. REFERENCE COLLECTIONS In order to properly identify and manage populations of insects, a good reference library and a representative collection of pest specimens should be available. Reference collections can be as simple as putting correctly identiﬁed insects in labeled photographic ﬁlm canisters. Preidentiﬁed insect specimen collections may also be purchased from several pest management specialty supply companies. © 2003 by Marcel Dekker, Inc.

VII. REFERENCE GUIDES TO PEST BIOLOGY, IDENTIFICATION, AND CONTROL The following is a list of the basic references that plant personnel should have available to help identify and manage pest populations within food processing facilities. American Institute of Baking. Basic Food Plant Sanitation Manual. Manhattan, KS: American Institute of Baking, 1979. American Institute of Baking. Quality Assurance Manual for Food Processors. Manhattan, KS: American Institute of Baking, 1991. American Institute of Baking. Warehouse Sanitation Manual. Manhattan, KS: American Institute of Baking, 1984. GW Bennett, JM Owens, RM Corrigan. Truman’s Scientiﬁc Guide to Pest Control Operations, 5th Ed. Duluth, MN: Advanstar Communications, 1997. FJ Baur, ed. Insect Management for Food Storage and Processing. St. Paul, MN: American Association of Cereal Chemists, 1984. JR Gorham, ed. Ecology and Management of Food-Industry Pests. Arlington, VA: Association of Ofﬁcial Analytical Chemists, 1991. JR Gorham, ed. Insect and Mite Pests in Food: An Illustrated Key. Agriculture Handbook 655. Washington, DC: U.S. Department of Agriculture. SA Hedges. Hide and Carpet Beetles/Wood-Boring Beetles, Vol 1 of Pest Control Technology Field Guide for the Management of Structure-Infesting Beetles. Cleveland, OH: GIE Media, 1996. SA Hedges. Stored Product Beetles/Occasional and Overwintering Beetles, Volume 2 of Pest Control Technology Field Guide for the Management of StructureInfesting Beetles. Cleveland, OH: GIE Media, 1996. SA Hedges. Pest Control Technology Field Guide for the Management of StructureInfesting Ants. Cleveland, OH: GIE Media, 1998. R Krammer. Pest Control Technology Technician’s Handbook: A Guide to Pest Identiﬁcation and Management, 3rd Ed. Cleveland, OH: GIE Media, 1998. A Mallis, ed. Handbook of Pest Control. 8th Ed. Cleveland, OH: Mallis Handbook and Technical Training Company, 1997.

REFERENCES 1. JR Gorham, ed. Ecology and Management of Food-Industry Pests. Arlington, VA: Association of Ofﬁcial Analytical Chemists, 1991. 2. AR Olsen, JS Gecan, GC Ziobro, JR Bryce. Regulatory action criteria for ﬁlth and other extraneous materials. V. Strategy for evaluating hazardous and nonhazardous ﬁlth. Reg Toxicol Pharmacol 33:363–392, 2001. 3. AR Olsen. Regulatory action criteria for ﬁlth and other extraneous materials. II. Allergic mites: an emerging food safety issue. Reg Toxicol Pharmacol 28:190–198, 1998. 4. AR Olsen. Regulatory action criteria for ﬁlth and other extraneous materials. III. Review of ﬂies and foodborne enteric disease. Reg Toxicol Pharmacol 28:199–211, 1998. 5. LD Foil, JR Gorham. Mechanical transmission of disease agents by arthropods. In: BF Eldridge, JF Edman, eds. Medical Entomology. Dordrecht: Kluwer Academic Pubishers, 2000, pp 461–514. 6. TW Phillips, MR Strand. Larval secretions and food odors affect orientation in female Plodia interpunctella. Entomologia Experimentalis et Applicata 71:185–192, 1994.

© 2003 by Marcel Dekker, Inc.

7. CH Bell. Factors governing the induction of diapause in Ephestia elutella and Plodia interpunctella. Physiol Entomol 1(2):83–91, 1976. 8. H Tsuji. Experimental studies on the larval diapause of the Indian meal moth Plodia interpunctella. Thesis, Kyushu University, Fukuoka, Japan, 1963. 9. LP Lefkovitch. A laboratory study of Stegobium paniceum (L.) (Coleoptera: Anobiidae). J Stored Products Res 3(3):199–212, 1967. 10. RT Arbogast. Beetles: Coleoptera. In: JR Gorham, ed. Ecology and Management of FoodIndustry Pests. Arlington, VA: Association of Ofﬁcial Analytical Chemists, 1991, pp 131– 174. 11. RW Howe. Spider Beetles: Ptinidae. In: JR Gorham, ed. Ecology and Management of FoodIndustry Pests. Arlington, VA: Association of Ofﬁcial Analytical Chemists, 1991, pp 177– 180. 12. IB Tarshis. The cockroach: a new suspect in the spread of infectious hepatitis. Am J Tropical Med Hygiene 11(5):705–711, 1962. 13. LM Roth, ER Willis. The biotic associations of cockroaches. Smithsonian Miscellaneous Collections 141:1–470, 1960. 14. PG Koehler, RS Patterson, RJ Brenner. Cockroaches. In: A. Mallis, ed. Handbook of Pest Control. Cleveland, OH: Franzak and Foster, 1990, pp 101–174. 15. ME Solomon. Ecology of the ﬂour mite, Acarus siro L. (⫽ Tyroglyphus farinae De G.). Ann Appl Biol 50(1):178–184, 1962.

© 2003 by Marcel Dekker, Inc.

20 Pest Birds: Biology and Management at Food Processing Facilities JOHN B. GINGRICH University of Delaware, Newark, Delaware, U.S.A. THOMAS E. OSTERBERG General Mills, Golden Valley, Minnesota, U.S.A.

I.

INTRODUCTION

A. Importance of Birds and Their Management in Food Processing Facilities Birds are one of the few universally recognized components of our natural environment. Birds serve alternately as predators, prey, food, and entertainment for hundreds of millions of people on a global basis. For this reason, they are perhaps the most anthropomorphized and widely appreciated group of animals other than domestic pets. Consequently, the subject of birds as pests can be controversial, and the subject of bird management can easily draw as much ﬁre as politics or religion. Because of their charisma, interesting behavior and aerial acrobatics, most people value birds on an emotional level. Their intelligent and highly adaptive behavior also makes them challenging pests of food processing plants and difﬁcult to manage. Birds in or around food processing facilities can cause direct physical damage to structures and equipment, create an unwholesome appearance around docks and doorways, contaminate food with feces and pathogens, and even carry ectoparasites (mites) that attack people. B. Deﬁning Pest Birds Deﬁning pests is a difﬁcult and highly subjective task. Truly, one person’s pests are another person’s pets. Deﬁning the species of birds that are pests is also a sensitive issue. © 2003 by Marcel Dekker, Inc.

Generally, any organism that is out of place and that interferes with human health or commerce is considered a pest. No matter what species it is, any bird that enters a building is a pest. Moreover, birds roost on loading docks, build nests in drains or downspouts, defecate on doors and windows, and loaf around air intake ducts—these birds are also pests. Since federal, state, or local laws and regulations protect nearly all birds, places where they can be controlled and the methods that can be used to control them are highly restricted. Such laws and regulations as the Migratory Bird Act and the Endangered Species Act prevents humans from killing and injuring most kinds of birds and, in some cases, even disturbing birds. There are only a few exceptions. Most states formally recognize two or three pest species and allow bird management programs against these species. However, the types of bird management programs permitted and the sites that they are allowed may be restricted [1]. The most commonly recognized pest species are the pigeon (Columba livia), the house sparrow (Passer domesticus), and the European starling (Sturnus vulgaris). A few states and locales also recognize herring gulls (Larus argentatus), crows (Corvus brachyrhynchos), ‘‘blackbirds’’ (a nonspeciﬁc common name that refers to several kinds of black-feathered birds including grackles, Quiscalus quiscala, and starlings), woodpeckers (referred to several species in the family Picidae), and cowbirds (Molothrus ater) as pest species [1]. Canada geese (Branta canadensis are recognized as agricultural pests in some areas [2]. However, these latter species nearly always require permits and special exemptions from protective laws and regulations before any sort of control program can be undertaken [1,2]. Pigeons, sparrows, and starlings, on the other hand, can often be managed without permits and with only minimal restrictions. We will discuss legal issues and regulations pertaining to birds in Section III. C.

Basic Bird Management Concepts

Bird management is based on the same sound integrated pest management (IPM) principles that are used to manage other pests. The principles of IPM require that all available methods be used to eliminate, mitigate, or prevent pests from interfering with human health, welfare, or commerce. Moreover, these principles dictate that before any pest management program begins, careful evaluation of the problem and precise identiﬁcation of the target pests must be carried out. In accordance with good IPM practices, it is customary to use the least invasive and least toxic methods available that will effectively ameliorate the pest situation. In other words, one should use good sanitation, sound storage practices, and exclusionary tactics in structures to prevent birds from being pests prior to using other, more intrusive methods. If these methods fail or are impractical, then methods that include chemical or physical deterrents and chemical pesticides may be used. In any case, bird management programs should not be expected to decrease pest bird populations overnight. In fact, the more permanent the solution is, the more likely that the decline in pest bird numbers will take place gradually, perhaps over a period of weeks. As with other animals, birds need food, water, and shelter in order to thrive and reproduce. Creating an environment unfavorable for bird feeding or reproduction, and thus slowly lowering the carrying capacity (ideally to zero), gradually causes more and more © 2003 by Marcel Dekker, Inc.

birds to depart. Other techniques for bird management such as applying avicides or bird repellents or resorting to shooting birds are undertaken only when quick suppression of pest bird population is needed because of potentially serious impacts of birds on human health or commerce. However, such methods often do not have a lasting impact unless the underlying conditions that permit birds to thrive at the site are also eliminated.

II. DAMAGE, RISKS, AND DISEASES ASSOCIATED WITH BIRDS A. Damage Damage to property and equipment is a frequently overlooked impact of bird infestations. Woodpeckers, although protected, often cause direct damage to siding, chimney, signs, and telephone poles. Most often, damage from birds is caused by their acidic feces, which, especially when moist, are very corrosive [3]. Bird feces accumulating on tar-based rooftops gradually cause the rooﬁng to disintegrate, eventually causing leaks (Fig. 1). A light, but continuous, infestation of birds on a ﬂat roof can halve the life expectacy of a roof. Likewise, bird feces damage air conditioning equipment, siding, insulation, and industrial machinery [4]. Not only is equipment damaged, but also workers who are exposed to bird feces experience increased health risks from disease when they work on contaminated machinery or take breaks in feces-contaminated areas (Fig. 1). Additionally, bird feces pit the paint of cars, airplanes, and boats. The longer the feces remain on the ﬁnish, the greater the damage. Bird feces can also damage plastics as they are being molded and can drop into other chemicals or liquids, producing a contaiminated product. Food contaminated by bird feces must be destroyed. Large quantities of bird feces, especially pigeon feces, on wet surfaces such as loading docks are a safety hazard because of the slippery conditions they produce.

Figure 1 An employee break area contaminated with feces—an unsafe and unhealthful environment.

© 2003 by Marcel Dekker, Inc.

B.

Risks

Risks of ﬁres associated with bird nests are very real, especially when the nests are built around electric motors or electriﬁed signs. In fact, electric sign companies blame most of their sign ﬁres on bird nests. Blockage of ventilation systems, especially chimneys, can lead to ﬂue ﬁres or even carbon monoxide poisoning. A family of ﬁve died in a carbon monoxide poisoning incident just before Christmas, 1995, because bird-nesting materials blocked the exhaust system of their ﬁreplace. Collapsed roofs can also occur when bird nests and droppings block gutters, drains, or downspouts. The weight of dammed water quickly overloads roofs when gutters and drains are blocked. In some cases, especially when pigeons nest in attics of homes or commercial buildings, the ceilings and insulation accumulate great quantities of solid and liquid bird waste. Over a period of years, the weight of the accumulated waste may cause ceilings to collapse. C.

Diseases and Parasites

The risk of human disease outbreaks arising from bird-associated pathogens would probably rank as the greatest concern for most bird management professions. Moist bird feces are a virtual culture medium for fungal spores and infectious bacteria, especially after the feces have dried out or have been leached repeatedly by rains [3]. Birds themselves are reservoirs of several viral diseases transmitted to humans by mosquitoes [1]. This section surveys the most important pathogens and agents of disease according to the major groupings—fungi, bacteria, viruses, protozoans, and ectoparasites. A summary table (Table 1) is provided as a convenient general reference, while details on diseases and their causative agents follow. 1. Fungi a. Aspergillosis. Aspergillosis is a disease of the lungs that can cause fever, cough, hemoptysis (bloody cough), chest pain, and asthma. Occasionally, cutaneous infections of open wounds or sores may occur. The most common pathogenic agents are Aspergillus fumigatus, A. ﬂavus, and occasionally A. niger [5]. Transmission occurs by airborne conidia that colonize the respiratory tract after exposure to aerosolicized bird feces or infectious soil at construction or renovation sites. Rarely, postsurgical infections occur in patients at central catheter sites or in burn wounds [6]. Transplant patients, hematologic malignancy patients, and AIDS patients occasionally become infected in hospitals. If prolonged granulocytopenia occurs, fatality rates can rise to nearly 100%. Incidence appears to have been increasing since 1983 (http:// www.cdc.gov), although good statistical information is lacking. b. Cryptococcosis. Cryptococcosis occurs most frequently in people who have meningitis or AIDS. Primary pulmonary infections seldom occur. The pathogen is an encapsulated yeast, Cryptococcus neoformans, that occurs in soils worldwide, but is particularly concentrated where soil and pigeon feces are commingled [7]. Transmission occurs by inhalation of airborne yeast spores. Cryptococcosis incidence averages only 0.2–0.9 per 100,000 in the general population, but often reaches 2–4 per 1000 among AIDS patients. About 12% of the cases are © 2003 by Marcel Dekker, Inc.

Table 1 Diseases Transmitted by Birds, Responsible Pathogen or Parasite, Mode of Transmission, and Most Likely Bird Species Involved

Disease

Pathogen/agent

Transmission mode

Likely bird species transmitting

Aspergillosis

Aerosolized bird feces or soil

PG, HS

Blastomycosis

Aspergillus fumigatus, A. ﬂavus Blastomyces dermatitidis

PG, ES, HS

Cryptococcosis

Cryptococcus neoformans

Histoplasmosis

Histoplasma capsulatum

Listeriosis

Listeria monocytogenes

Psittacosis Salmonellosis

Chlamydia psittaci Salmonella typhimurium

Encephalitides

St. Louis, Western, Eastern equine, and West Nile viruses Toxoplasma gondii

Soil contaminated with bird feces Soil contaminated with bird feces Spores taken in through HVAC ducts Food or soil contaminated with bird feces Aerosolized bird feces Food contaminated with animal feces From birds through bite of infective mosquitoes

Toxoplasmosis Ectoparasites

Mites, ﬂeas, ticks, lice, bird bugs

Food contaminated with animal feces Contact with birds or bird nesting material

PG PG, ES, HS? PG, ES, HS HS, PG PG, ES, HS HS, ES, PG

PG, ES, HS PG, ES, HP

Note: PG: pigeon; ES: European starling; HP: house sparrow.

fatal. In meningitis patients, blindness and permanent neurological damage can occur. AIDS patients must take antifungal agents for life, as the disease is never cured. c. Histoplasmosis. Histoplasmosis is probably the most common of the fungal diseases that colonize the human respiratory tract. The areas of greatest endemicity in the United States include the central and eastern states from the Mississippi and Ohio River valleys northward to the St. Lawrence River. Although nearly 80% of populations in endemic areas have antibodies to the etiologic agent, only a very small number actually get the disease. The disease presents with an inﬂuenza-like illness with fever, cough, headaches, and muscle pains. This disease can cause acute or chronic pneumonias that are very difﬁcult to cure. In AIDS patients, the infection may present as septic shock. Chronic disease caused by this pathogen can lead to permanent lung damage and blindness. Mortality in AIDS patients who contract histoplasmosis is about 10%. The pathogen Histoplasma capsulatum is transmitted on airborne particulates emerging from disturbed soil contaminated by bird or bat droppings. Pigeon droppings around HVAC systems, cooling towers, or air intake vents create a high degree of risk for this disease (Fig. 2). High-risk groups include spelunkers, construction workers, agricultural workers, and immunocompromised persons, especially AIDS patients. © 2003 by Marcel Dekker, Inc.

Figure 2 Pigeon feces accumulating around an HVAC system. This creates an ideal situation for histoplasmosis and other fungal pathogens to be transmitted to workers inside the building.

d. Blastomycosis. Blastomycosis is another fungal disease that causes pneumonia. It can disseminate to affect skin, bone, and other organ systems. This disease is caused by inhalation of the conidial spores of Blastomyces dermatitidis that contaminate soil, primarily in wooded areas or along waterways. High-risk groups include forestry workers, campers, hunters, and farmers (http://www.cdc.gov). Fatality rates up to 5% are reported, with about 1–2 cases per 100,000 occurring in endemic areas. 2. Bacterial Diseases a. Psittacosis. Psittacosis, also known as ornithosis or parrot fever, is a zoonotic disease that occurs in members of the parrot family and in turkeys and pigeons [5]. This disease, transmitted to humans by inhalation of airborne particulates of dried bird feces or by direct handling of infected birds, is the most common disease transmitted from birds to people [8]. Dried bird feces may remain infected for weeks. The disease, caused by Chlamydia psittaci, shows elevated risk in pet store workers, farmers, and slaughterhouse workers who process turkeys. The disease starts, 1–4 weeks after exposure, with signs that include headache, fever, chills, and sometimes pneumonia. In birds, signs include poor appetite, a rufﬂed appearance, eye or nose discharges, and diarrhea. Unfortunately, past infection with the disease does not confer immunity. Data on incidence and prevalence are very sporadic. b. Listeriosis. Listeriosis is a facultative zoonotic disease. Its reservoirs include water, mud, and silage, as well as domestic and wild animals and man [5]. In humans, about 30% of cases occur in newborns less than 3 weeks old. In adults, most cases occur after age 40, especially in immunocompromised persons. Incidence rates in the United States for people requiring hospitalization are about 1 per 150,000 people. The disease manifests © 2003 by Marcel Dekker, Inc.

itself as meningoencephalitis, with or without septicemia. Onset can be sudden, especially in neonates. Neonates who acquire the disease within 4 days of birth have fatality rates of up to 50%. In adults, fatality rates often approach 33%. The ubiquitously present pathogenic agent for this disease is Listeria monocytogenes. The disease is transmitted by many vehicles, including unpasteurized milk, cheese, and vegetables. Papular lesions on hands and arms may occur through direct contact with infectious material or soil contaminated with infectious bird or animal feces. Mixtures of soil and bird waste can remain infectious for months. Nosocomial outbreaks in nurseries occur through contact with the hands of infected nursing or other medical staff. The incubation period is highly variable, ranging from 3 to 70 days. c. Salmonellosis. Salmonellosis, another common bacterial disease that is worldwide in distribution, is also one of the more common zoonotic diseases. According to the Centers for Disease Control and Prevention (CDC), up to 1.4 million cases of this disease may occur annually in the United States. Two of the causative agents, Salmonella typhimurium and S. enteritidis, are generally considered foodborne pathogens [5]. However, contamination of foodstuffs with these agent occurs through numerous vehicles, including feces of infected birds. All three of our common pest bird species frequently harbor this pathogen, additionally they habituate feedlots, poultry farms, and food processing plants where the opportunity to contaminate foodstuffs is high [3]. The pathogens are most commonly passed through the fecal–oral route to animals or food products contaminated with feces. Disease manifestations include severe headache, abdominal pain, diarrhea, and dehydration. The disease is highly contagious, with an infective dose consisting of only 100 to 1000 organisms [5]. There are other bacterial pathogens that can be spread by birds, but because this happens only infrequently, they are not considered in this chapter. 3. Viral Diseases The human viral diseases associated with birds are not directly transmitted by birds to people. However, birds are so important in the overall epidemiology of these diseases that their role is considered essential to transmission. Encephalitides are the principal viral diseases affecting humans for which birds are the principal reservoir hosts. In the United States, the most important diseases in this group are eastern equine encephalitis, St. Louis encephalitis, western encephalitis, Venezuelan encephalitis, and, just recently, West Nile fever. Birds, including our U.S. pest species, have been implicated as major reservoirs of this group of diseases. Although few of the pest birds become ill themselves with this group of diseases, they develop high viremias, permitting the mosquito vectors that feed on them to become highly infective. In the United States, West Nile fever is an important exception to the lack of morbidity observed in birds infected with encephalitis. Birds exposed to West Nile fever virus frequently become ill or die from this pathogen. It is theorized that because birds in the United States have not yet adapted to this recently introduced pathogen, they are therefore highly susceptible to it. Corvine birds (crows), sparrows, and starlings are generally susceptible to this virus, although only crows have been observed dying in large numbers. Pigeons, while susceptible to some degree, do not appear to be adversely affected, according to recent information from the CDC. © 2003 by Marcel Dekker, Inc.

4. Protozoans Toxoplasmosis is a systemic disease caused by Toxoplasma gondii [5]. The disease generally causes a mild, asymptomatic infection in humans, but also may present as a disease resembling infectious mononucleosis. An acute case presents with swollen lymph glands and high fever. This phase of the disease may give rise to cerebral involvement and pneumonia in immunocompromised persons. In pregnant women, the disease may lead to severe fetal distress or even death in a newborn that acquires this disease from its mother. The disease is transmitted through a number of routes, especially soil contaminated with the feces of infected cats. Pigeon or cat feces contaminated with oocysts of this pathogen may be inhaled or consumed with contaminated food. 5. Ectoparasites Although birds host numerous mite species, two species are most commonly known to transfer from birds to humans. These are Dermanyssus gallinae, the chicken mite, and Ornithonyssus sylviarum, the northern fowl mite [9]. The bite of the chicken mite is often painful and causes papular urticaria in humans. The bite of the northern fowl mite causes immediate irritation and subsequent erythema, induration, and pruritis [9]. Chicken mites may carry the viruses that cause encephalitides, although it is uncertain that they can transmit them to humans. The northern fowl mite carries the pathogens of encephalitides and ornithosis, although transmission to humans is, once again, uncertain. Additionally, a number of other ectoparasites associated with birds may occasionally transfer to humans. Pigeon nest bugs (Cimex columbarius) inhabit pigeon nesting sites and sometimes transfer to humans after their usual hosts leave their nests [10]. Ceratophyllus columbae and C. gallinae, common bird ﬂeas especially associated with pigeons, may occasionally attack humans, but normally only in the prolonged absence of their bird hosts. Argas reﬂexus, the bird tick, is commonly associated with pigeons, but may also occur on other birds [10]. It attacks humans when bird nests in and around human structures are abandoned. Several species of biting lice, most notably Columbicola columbae and Campanulotes bidentatus, infest pigeon feathers [10] and may occasionally bite humans when bird feathers or nests are handed by humans. The conenose bug (Triatoma rubrofasciata) is commonly associated with pigeons and other bird species [10]. This bug can inﬂict a painful bite to humans when bird-nesting material is handled.

III. PEST SPECIES AND THEIR BIOLOGY A.

Pigeons

The pigeon, also known as the European rock dove, is widely distributed througout the world. Introduced into North America in the 17th century, it was then primarily used as food. Birds often escaped, adapted rapidly to living in urban areas, and the rest is history. A typical pigeon is 11–12 in. (28–31.5 cm) long and weights 13–14 oz (368.5– 397 g) [3]. It is generally light gray in color, but often with other colors mixed in, including purple, white, green, brown, tan, and black (Fig. 3). Legs and feet exhibit a reddish color, with three toes facing front and one to the rear. © 2003 by Marcel Dekker, Inc.

Figure 3 The pigeon (Columba livia). This species is also called the European rock dove.

Pigeons feed on a variety of foods, including garbage, insects, seeds, and nuts [1]. They eat about 1 lb of food per week, but they do not have to eat every day. However, pigeons must have water every day [3]. They are highly urban birds that frequently depend on human structures for nesting, roosting, and loaﬁng sites. Flocks consisting of 20 to 100 or more birds feed, roost, nest, and loaf together. Nests, usually built by monogamous pairs, consist of crude, loosely formed aggregations of twigs, grasses, and sticks, the whole measuring about 12 in. (30.5 cm) across. Nests are built on ﬂat surfaces—ledges, rocky cliffs, alcoves, roofs, and under bridges. Only one or two eggs are deposited in each nest, although more eggs are usually laid before the ﬁrst brood is weaned. After 17 to 19 days of incubation, the hatchlings (called squabs) emerge and are fed a regurgitated substance called pigeon milk. Squabs eat this substance exclusively for the ﬁrst 5 days of life, after which they receive increasing amounts of grains, food waste, insects, and water [1]. Young pigeons wean in about 10 days and ﬂedge about 4–6 weeks after hatching. Pigeons reproduce in all seasons, but peak reproduction occurs in the fall and spring in temperate climates. Although pigeons can live up to 15 years in the wild, the average urban pigeon lives only 3–4 years [3]. Pigeons have rather varied feeding, roosting, loaﬁng, and nesting behavior. However, they tend to frequent the same sites year after year, resulting in huge accumulations of feces, feathers, and nesting debris at their chosen sites. Pigeons prefer ﬂat surfaces for feeding or resting. Consequently, they are often seen feeding on rooftops or open grassy areas. Grain spillage around food processing plants is major food source for pigeons [1]. Feeding and roosting sites are generally not in the same location; in fact, they may be miles apart. Roosting and nesting sites are generally on ledges or rooftops of buildings. These habitats put them in direct conﬂict with man, as they rapidly contaminate these sites with excrement and feathers. When they nest or roost around cooling towers or © 2003 by Marcel Dekker, Inc.

rooftop HVAC systems, the chance to transmit one or more of the many fungal and bacterial diseases they carry is greatly enhanced. Pigeons also are great ‘‘loafers,’’ meaning that they may simply rest, especially during the daytime, in places where they do not feed or roost, although such sites may be close by. This aspect of their behavior makes management of ﬂocks at loaﬁng sites difﬁcult, since simply limiting the amount of food or water at these sites does little good [1]. B.

House Sparrows

The house sparrow (also known as the English sparrow), introduced to the United States in the 1850s [3], is actually a member of the Old World weaver ﬁnch family (Ploceidae), rather than a true North American sparrow (Fringillidae). House sparrows easily out-compete many native birds for food and habitat and often displace purple martins (Progne subis), eastern bluebirds (Sialia sialis), redheaded woodpeckers (Melanerpes erythrocephalus), cliff swallows (Petrochelidon pyrrhonota albifrons) and barn swallows (Hirundo rustica erythrogaster) [11]. House sparrows are so proliﬁc that a dozen nesting pairs may increase to thousands in only 3 to 4 years. This small, stocky bird is about 5–6.25 in. (15–18 cm) in length. The dorsal parts are reddish brown streaked with black, while the ventral aspect is a light gray, with a black throat in the male. Sparrows feed primarily on fruits, buds, emerging plants, and insects. Nests are built in trees or on human structures such as loading docks, eaves, gutters, ledges, signs, electrical substations and bridges. Five or six greenish, speckled eggs are produced four to seven times per year, depending on the availability of food and water. They hatch in 11–12 days, and ﬂedge at about 15 days. Soon after leaving the nest, they gather in small ﬂocks for feeding purposes. As the summer progresses adults join the ﬂocks, and by the end of the summer ﬂocks may include several hundred birds each [1]. Sparrows build relatively large nests, a jumble of grass stems, leaves, twigs, and trash. Nesting areas quickly become deﬁled by feces and, therefore, are highly likely to harbor pathogens in fecal or nesting material. Sparrows are important reservoirs for St. Louis encephalitis, but are generally unharmed by the virus [12]. Their propensity for feeding or nesting in ﬂocks means that they can be very troublesome around food processing facilities and warehouses. This problem is exacerbated by their small size and aggressive feeding style, which often lead them to invade buildings and become trapped in highly visible production or distribution sites, from which they are ejected only with great difﬁculty. Like pigeons, sparrows return to the same nesting, feeding, and roosting sites year after year. These sites are generally all located within a 2-mile radius of one another. C.

European Starlings

The European starling (family Sturnidae) was introduced to New York in the 1890s. After about 30 years of living in the northeast, starlings rapidly spread from coast to coast, and now extend all the way to Alaska [13]. In 1988, their U.S. population was estimated to be approximately 140 million [3]. This species is a robin-sized bird that appears mainly dark, sometimes with glossy purple feathers that are ﬂecked with brown spots upon closer inspection. These spots increase in number and are more pronounced in winter plumage (Fig. 4). Their bills are yellow in spring and summer.

© 2003 by Marcel Dekker, Inc.

Figure 4

The European starling (Sturnis vulgaris) shown in winter plumage. This photo shows a bird invading and nesting above a dock door where bird netting was ripped by careless repairs to the door mechanism.

In springtime, they build nests of ﬁbrous materials lined with ﬁne grasses in building cavities, in crevices, between loading dock door tracks, behind signs and marquees, and in numerous natural sites. They produce an average of two broods per season, with four to seven young per brood. The eggs are bluish to white. Hatching occurs in about 12 days. The birds ﬂedge in 2 to 3 weeks. During the breeding season, mated birds disperse to nest sites, while ‘‘bachelor’’ birds travel together in small ﬂocks to feed and roost. As summer progresses, more bachelor birds and their parents join the ﬂocks. By late summer, ﬂocks may number in the hundreds or thousands, and become increasingly difﬁcult to manage. Trees are favored roosing sites, and at such roosts thousands of birds in a few trees make a lot of noise and deposit copious quantities of droppings and shed feathers. Feeding and roosing sites are often widely separated, often by as much as 70 miles [1]. Starlings are primarily insectivorous, but also feed widely on fruits such as grapes, ﬁgs, cherries, and apples. In winter they increase their feeding on grain and seeds; these foods may constitute a large part of their diet in this season. However, when food is scarce they will feed voraciously on nearly anything, including garbage. Their close association with people in urban areas makes them threats to transmit fungal and bacterial diseases directly and also to serve as reservoirs for viral encephalitides [15]. Their aggressive foraging behavior also makes them second behind sparrows with regard to building invasions. IV. LAWS AND REGULATIONS PERTAINING TO BIRDS AND BIRD MANAGEMENT Prior to reviewing bird management methods, it is important to recognize the limitations imposed by federal, state, and local laws. The Migratory Bird Treaty Act of 1918 (16 USC 703–712) is the cornerstone for migratory bird protection and conservation in the

© 2003 by Marcel Dekker, Inc.

United States [14]. The ﬁrst provision of the act prohibits shooting of native migratory birds in the United States, except in accordance with regulations promulgated by the Secretary of Agriculture (37 Stat. 847). This law was supplemented by treaties with Canada (1916), Mexico (1936), Japan (1972), and the former Soviet Union (1978). In addition to prohibiting killing, the act prohibited taking, capturing, possessing, selling, purchasing, exporting, importing, or transporting any migratory bird, bird part, nest, or eggs. The word take is deﬁned to mean to ‘‘pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to pursue, hunt, shoot, wound, kill, capture, or collect’’ (50 CFR 10.12). The exceptions permitted by law are hunting speciﬁc game birds with possession of a hunting license, legitimate research activities, display in zoological gardens, birdbanding, and similar activities. Of 1043 native species in the United States, 83% (868 species) are protected by this law. The species not protected include domesticated game fowl, introduced species, and island species that belong to groups not covered by the act. Additionally, blackbirds— red-wing (Agelaius phoeniceus), yellow-headed (Xanathocephalus xanthocephalus), tricolored red-winged, rusty (Euphagus carolinus), and Brewer’s blackbird (Euphagus cyanocephalus)—cowbirds, grackles, crows, and magpies (Pica pica hudsonia) are not covered by the act when concentrated in such large numbers and under such conditions as to constitute a health hazard or other nuisance [15]. The Endangered Species Act of 1978 (87 Stat. 884, 16 USC 1531–1543) protects endangered species and their habitats, as determined by the Secretary of the Interior. A list of threatened and endangered species is published in the Code of Federal Regulations (50 CFR 17). Executive Order 11643 (1972) limits the use of chemical toxicants against predatory animals and birds. This order contains restrictions and exemptions pertaining to use of toxicants on federal lands only. In addition to these national-level laws and regulations, numerous states and local jurisdictions restrict the use of avicides, repellents, and bird control techniques. Frequently, these regulations are stricter than federal codes, hence superseding them. These regulations often require permits and prohibit nest destruction or other bird harassment methods. It should be noted that in bird sanctuaries, even pest birds cannot be controlled without involved legal procedures [15]. V.

PREVENTION OF BIRD INFESTATIONS THROUGH GOOD SANITATION PRACTICES

Bird management efforts focus on habitat modiﬁcation in combination with structural exclusion techniques represent the best overall strategy. Such modiﬁcation involves the systematic removal of food, water, and shelter sources necessary to sustain a pest bird population [16]. Most kinds of urban pest birds actively scavenge in trash and garbage. Reducing the availability of these vital resources increases dramatically the level of stress in the local pest bird population and can, over time, result in drastically reduced numbers of birds. The food plant sanitation management program should be written so that it includes the periodic inspection of the exterior grounds and the roof areas of all buildings. During the inspection, any area containing spills of food material should be identiﬁed, followed by the prompt removal of the spilled material. The source of the spillage should be noted as well for follow-up corrective action. Such inspections should be performed at regular © 2003 by Marcel Dekker, Inc.

intervals (at least monthly). Reports generated from such inspections can be used to develop a history of circumstances that lead to bird infestations. This history can subsequently be used in developing a successful control strategy. Naturally occurring food sources may also be available. Such sources must be identiﬁed and eliminated whenever possible. With respect to the facility grounds and landscaping, planting of various trees and shrubs for aesthetic purposes often also provides food and shelter for birds. While pleasing to the eye, plants that produce berries and seeds are a major attraction for birds. In addition, insect pests that harbor in such plantings are often prey for birds. Therefore, it is best to minimize plantings around the facility and especially to keep plantings as far as possible from the exterior walls. When plantings are done, they should be done in consultation with a horticulturalist or local wildlife extension specialist. Should the decision be made to install trees, shrubs, and ground covers, choose plants with foliage that is least attractive to pest birds. Most birds require water daily. As with food, water is vital for birds, and large populations cannot be sustained without it. Therefore it is important for the sanitation management system to account for all available water sources, making every effort to limit the amount of water available to pest birds. A periodic inspection of the plant grounds, to include building roofs, parking lots, rain gutters, downspouts and drainage ditches, must be made so that all water sources are identiﬁed and eliminated if possible. Ideally, such inspections sould be conducted at least monthly until all water sources are identiﬁed. In some cases, it is possible to completely eliminate the source. Rain gutters and downspouts can be periodically cleaned to remove blockages that restrict ﬂow and result in pooling. Plugged roof drains can be cleaned so that standing water on roofs is eliminated. Pooled water in parking lots can be swept to the nearest storm water drain. The labor costs sustained in the manual removal of pooled water in the parking lot can be balanced against the cost associated with adequate repairs to prevent water pooling. In a word, prevention of water pooling may be the least expensive, long-term option when compared to the ongoing costs associated with the remedial removal of water after every rain shower. If, indeed, pooled water in a parking lot is identiﬁed as a contributing factor in sustaining large bird populations around the facility, it would follow that costs associated with overall bird-control efforts would be positively impacted by a preventive approach to the problem, rather than a reactive one. In other situations, for example drainage ditches, restricting accessibility to water is difﬁcult. Depending upon the type of pest bird, the size of the local population, and the relative importance of the water source to the population, drainage ditches can be protected from pest birds with netting so that the water in the ditch is difﬁcult to access. By limiting usable water sources, pest bird populations can be greatly reduced. Shelter from the elements, from predators, and for the rearing of young is another important factor necessary for birds to thrive. With respect to reducing the amount of available shelter, the following speciﬁc points should be considered: 1. Tree and shrub canopy reduction. Reduce or elminate dense tree canopies and other foliage from around the structure to be protected [16]. Trim branches to reduce roosting sites for European starling populations. Sparrows may nest, as well as roost, in low shrubs. Plantings that are well trimmed and thinned will help to keep sparrow populations low. 2. Vine removal. Remove vines and other foliage from building structures. Sparrows ﬁnd such vines very attractive for nesting [16]. © 2003 by Marcel Dekker, Inc.

3.

4.

5.

6.

Keeping grass short. Sparrows are seedeaters; keeping grass mowed short reduces the quantity of natural seed available. Short grass also helps to reduce the available harborage for insects that are also highly utilized as a source of food by sparrows [17]. Minimizing Ground Cover. Trim or remove excessive ground cover that can act as bird harborage and habitats for insects. Insects thriving in lush ground cover serve as food for birds. Nest Removal. Consistently remove nests as they are being constructed. During the nesting season, nests should be moved at 10–14 day intervals to discourage birds from nesting [18]. Effective methods include physical removal using poles with attached hooks or destruction of the nest with high-pressure water [16]. After removal, discard all nesting materials (sparrows will recycle debris from destroyed nests if they have access to them). Employees should be properly protected when handling nesting materials. At a minimum, workers should wear chemical splash goggles, latex gloves, and a disposable respirator. Although nest destruction campaigns are generally effective in reducing the numbers of birds around a structure, such programs require persistent effort throughout the nesting season. Keeping waste disposal areas clean. Maintain clean compactor/dumpster areas. These areas are visited frequently by birds and other pests for food and water. Keeping such areas well maintained and free of spillage will help to minimize birds and other pests. If water pools around the dumpsters, install a drain. Pooled water is highly attractive to birds and other pests.

VI. PREVENTION OF BIRD INFESTATIONS THROUGH SOUND STRUCTURAL MODIFICATIONS AND DESIGN PRACTICES A.

Structural Modiﬁcations

This important component of habitat modiﬁcation can pay huge dividends in reducing the attractiveness of food processing facilities to pest birds. Birds will utilize almost any gap, crack, or protected site for nesting or resting sites [19]. As a part of the facility inspection, make a list of all areas that contain possible nesting or resting sites, then determine the best methods to get rid of the problem sites. Speciﬁc examples of modiﬁcations that reduce the carrying capacity of the facility are as follows: Block spaces under corrugated roofs to preclude nesting activity of sparrows [16]. Materials that can be used, depending on the speciﬁc circumstances, include hardware cloth, expandable foam, sheet metal, and bird netting. When using foam, it is important to use a precision foam gun (not an areosol can) so that no gaps are left. The birds will take advantage of any gaps, enlarging them to gain access. Remove signs from the side of buildings, or place them tightly against the side of the building. Sparrows are notorious for building nests between signs and buildings [18]. Lighted signs, providing both shelter and warmth, are highly attractive to pest birds. Where sign removal is impossible or placement is not ﬂush, block the gaps between the building and the sign with an appropriate netting or screening material [3]. When designing new dock areas and protected overhangs, consider the use of tubular supports (square or oval) rather than I beams. I beams provide abundant nesting © 2003 by Marcel Dekker, Inc.

and roosing areas. Seal the ends of the tube members completely to prevent pest entry into the interior area of the tube. Useful types of exclusion materials include hardware cloth, sheet metal, and expandable foam. Lights placed directly on building exterior walls often serve as nesting sites, especially for sparrows. Moreover, exterior lighting can be highly attractive to ﬂying insects that will, over time, enter the facility. Rather than placing lights directly on the building, they should be erected on poles distanced from the building and directed toward the area to be illuminated. Insects are attracted to the area of greatest light intensity, meaning they will gravitate toward the light itself, now located many feet from the building. Lights on poles can also be attractive as nesting sites for birds. Several simple physical deterrents can be used to keep birds off such lights. Metal or plastic ‘‘bird spikes’’ can be trimmed to the most appropriate size and afﬁxed to the light with a high-quality, weather-resistant adhesive. Other options, depending upon the size of the light and adjacent obstructions, include the use of springing wires available from commercial suppliers of bird exclusion devices. This device consists of long, protruding ‘‘legs’’ attached to a central spindle that slowly rotates with air movement. The horizontal movement, coupled with the up-and-down movement of the legs, is bothersome to birds. Another consideration is that building lights should be sodium vapor lamps as opposed to mercury vapor lamps. The former lamps are generally unattractive to insects, while the latter lamps are highly attractive. Fire alarm bells are notorious nesting sites, especially for sparrows. As with lights, there are probably alternative locations where ﬁre alarms can be installed. However, consultation with ﬁre safety professionals is highly recommended before making such changes. B. Structural Design The best opportunity to build birds out of a food processing facility is during the design phase [3]. Incorporating sound structural features at this point can make a facility resistant to bird encroachment and can greatly reduce the cost of later corrective action. Some of the most important design features that should be considered are as follows: In general, any ﬂat, protected site can be used by pest birds for roosting and nesting. Therefore, structural designs that limit such sites help prevent bird encroachment. The use of I beams as structural support members should be avoided and tube members used instead. Overhangs in loading/receiving dock areas should be constructed using a cantilever design that limits the number of open supports. If horizontal supports are required, these should be tube members, not I beams. If ‘‘I’’ beams must be used, then the open ends will require sealing or netting to restrict access to pest birds. Window ledges and other similar structures should be limited to the greatest extend possible. Pigeons nearly always ﬁnd these ledges and, if they afford protection from the elements and from natural predators, will soon roost and probably nest as well. Other ledges can be made undesirable as roosing or nesting sites by increasing the © 2003 by Marcel Dekker, Inc.

Figure 5 Building out birds. The overhang of this building is constructed at a 45° angle to keep birds from nesting at the site. angle of the upper surface to at least 45° (Fig. 5). Birds will avoid using such sites. This is a difﬁcult and expensive retroﬁt for existing structures. As an alternative, there are various physical exclusion devices that can be placed on such ledges to deny access to birds. These devices will be discussed in Section VII. Avoid afﬁxing anything to the side of the building that could be used as a nesting site. Signs, lights, and ﬁre alarms all provide suitable nest sites. Openings into the building must be sealed. Areas under corrugated roofs can be sealed or netted to exclude birds. Dock doors must be kept closed when not in use. It is a common practice to erect plastic strips along the threshold of the dock door in an attempt to limit birds from entering the facility. Invariably, however, employees ﬁnd these strips a nuisance and either cut them off short or tie them back against the doorframe, essentially negating their effectiveness. © 2003 by Marcel Dekker, Inc.

High-speed, automatic dock doors are available that, when properly synchronized with an electric eye, remain closed when not in use. These doors must be properly timed and periodically adjusted so that they close tightly, close at the appopriate time and speed, and do not risk employee injury. Manual, roll-up doors are sometimes used at dock entrances. Keeping roll-up doors closed requires a conscientious effort by employees (workers are often inclined to leave the doors open for ventilation and convenience). Roll-up doors also present high potential for insect infestation inside the housing of the roll-up mechanism. The space inside the housing is virtually impossible to access for cleaning. VII. PEST MANAGEMENT METHODS FOR BIRDS IN FOOD PROCESSING PLANT Once birds become established in or around food processing plants, it then becomes a challenge to devise corrective methods that can be implemented. There are many creative and effective solutions that could be considered. However, we will focus on the most frequently used and most cost-effective methods. Before starting any of these methods, it is important to conduct a bird survey to establish the kinds and numbers of birds present, their feeding, resting, and nesting sites, and their activity patterns [3]. Avoiding this step can be a costly mistake because birds frequently present different behavior patterns at different times of the day. For example, excluding birds only from the area where you see birds resting at noon may overlook places where they might be roosting overnight, and nesting sites might be overlooked altogether. As a general rule, bird surveys should be conducted in the early morning, at noon, and again about dusk. This will provide the broadest array of information on bird activity for the least amount of time spent. These surveys should be done formally, using binoculars and a survey form on which to record speciﬁc bird activities [3]. Based on this survey, the bird management specialist should be able to determine the sites of activity, appropriate management methods, cost, and likely outcomes. If the bird management involves harming birds, or is likely to result in sighting of disoriented or trapped birds by the public, then a public relations campaign may be needed before starting the bird management progam. Failure to consider public relations may doom the campaign and totally negate any beneﬁts obtained [3]. A. Exclusion Exclusion can be accomplished by a variety of measures, many of which have already been discussed in broad terms. In general, exclusion is least objectionable to the public and most apt to yield permanent results. Holes and gaps can be sealed with hardware cloth, mortar patching, sheet metal, expandable foam, and netting. Large nesting sites on docks built with I beams or exposed metal framing generally are most effectively eliminated by installation of bird net [1]. Similarly, netting is probably the most economically efﬁcient method for protecting large cooling tower areas or rooftop HVAC systems against bird damage (Fig. 6). Netting is usually made of a synthetic plastic mesh that comes in different grid sizes, depending on the type of bird to be excluded [1]. Mesh sizes are generally 0.75 in. (2 cm) for sparrows, 1.25 in. (3.2 cm) for starlings, and 2.0 in. (5 cm) for pigeons. It is important to note that in order to satisfy the terms of the manufacturer guarantees, the © 2003 by Marcel Dekker, Inc.

Figure 6 Building out birds at a loading dock. The overhang of this dock is cantilevered in such a way that birds cannot use the supports for nesting.

netting must be installed on a wire cable frame solidly afﬁxed to the building and stretched taut using turnbuckles, ensuring that everything is square. It is very important that netting installation be done by a professional installer, since special equipment and skills are needed to do a proper job. Improperly installed netting not only nearly always fails to exclude birds, but also voids manufacturer guarantees. Eventually, it will have to be torn down and done right. It is also important at the outset to install trap doors and access panels in the netting for replacing lights, entering overhead panels, and repairing equipment so that the net is not cut later by building engineers who do not appreciate the cost of repairing netting. Netting comes in several colors, so it is easy to pick a type of net that is virtually invisible to the casual observer. B.

Repellents and Deterrents

Repellents and deterrents can be categorized into three types; virual, auditory, and tactile. 1. Visual Repellents Visual repellents in the form of fake owls and hawks, enlarged eyes, shiny ﬂags, balloons, and ﬂashing lights have been used but with limited success. While such devices may work for a short period of time, the birds generally become accommodated to them within a matter of days and ignore them thereafter [3]. There are many reports about fake owls installed on a rooftop, with dozens of pigeons roosting or loaﬁng all around them. 2. Auditory Repellents Auditory repellents do not fare much better. Examples of auditory repellents include alarms, horns, gunﬁre recordings, explosion recordings, ‘‘canned corn’’ (noisemaking py© 2003 by Marcel Dekker, Inc.

rotechnics), and bird distress calls. Pigeons and sparrows seldom respond for more than a brief period, as these species are well adapted to the noisy situations normally encountered in urban and industrial settings. Recorded bird distress calls will cause starlings to leave a roost, but usually also cause them to roost in a nearby area, from which they then likewise must be dislodged. Such tactics generally result in the alarm recording being ferried from one area to another for nights on end, annoying the public, and requiring a considerable investment in labor and equipment. Ultrasonic devices do not work at all. Since birds have a hearing range similar to humans [20], they are unable to detect ultrasonic waves. 3. Tactile Deterrents Tactile deterrents include various formulations of polybutylene or polybutene, otherwise known as ‘‘hotfoot.’’ While these repellents do work, they are sticky and messy, especially on porous surfaces. On hot days, the repellent material may become runny and drip down onto signs or the sides of buildings. Moreover, the material quickly becomes coated with soot, nesting materials, feathers, and feces, resulting in a messy, black paste that is unsightly, difﬁcult to remove, and ineffective. Two other widely used products are considered tactile repellents, although they could also be considered as exclusionary products. Porcupine wire is one of the more common products used for birds. It comes in a variety of designs, most often with prickly, 3- to 4-in. (7.5- to 10-cm) spikes extending upward. These products come in 3- to 5-ft (0.9 to 1.6-m) strips of wire or plastic spokes. Each strip covers 3–5 in. (7.5–12.5 cm) of width on a ledge. They can easily be afﬁxed to ledges, beams, or other bird resting sites with a silicone glue (Fig. 7). Normally ledges that are used for this type of installation will be less than 1 ft wide (⬎31.5 cm), so that not more than three rows of porcupine wire need to be installed. Porcupine wire is highly effective against pigeons and starlings, but less so against spar-

Figure 7 Bird netting is used to exclude pigeons from a large rooftop HVAC system. © 2003 by Marcel Dekker, Inc.

rows, which may actually drop nesting materials among the spikes and even establish nests in it under some conditions. Pin and wire is another commonly used structural tactile deterrent. It is generally used in the same situation where porcupine wire is used, i.e., on ledges not over 1 ft (31.5 cm) wide. The product is tricky to install correctly, but is less visually noticeable than porcupine wire and less likely to be used by sparrows for nesting space. Pins must be installed by ﬁxing them into a masonry surface using a drill. Thin wires, stretched tightly between the pins, usually in parallel rows, vibrate with the slightest touch. It is the vibration of the wire that appears to unnerve birds that attempt to settle on ledges protected by pin and wire. Some versions of pin and wire may also be electriﬁed, making them even more disruptive for birds. The ‘‘spider legs’’ set-up is another effective tool for protecting small ﬂat surfaces against birds. The legs radiate outward 3–4 ft (94.5–126 cm) from a central spindle that moves with air currents, allowing the springy wires to scare birds off the surface (Fig. 8). C.

Trapping

Trapping of birds can be effective when done professionally and in the right situations. The most difﬁcult situation is trapping a sparrow or starling inside a building with a high ceiling. The pest bird may remain near the ceiling of the building most of the time, making only occasional forays to food or water sources at ﬂoor level. Traps designed for individual sparrows or starlings can occasionally be successful. However, the trap must be prebaited for 1–2 days to allow the bird to become accommodated to it and must have virtually the only source of food or water available. It should always be used with the food that the bird is most accustomed to eating. Where the public is present, placing the trap out of sight is an essential, but sometimes difﬁcult, task. Removal of trapped birds must be done discreetly, and release well away (several miles/kilometers) from the premises is required to prevent them from returning. Pigeon traps can be used effectively on rooftops where pigeons frequently rest or loaf. These traps typically have two one-way doors that allow entry but not exit. Prebaiting the traps with whole, dried corn for 3–4 days is generally required prior to setting the trap doors. After this, the traps may be set in the morning and pigeons removed in the late afternoon or evening. One bird should always be left in the trap as a decoy at the end of the day. To be effective for a typical ﬂock of 50 to 100 birds, four or ﬁve traps must be set in a range of sites on the rooftop. Each trap will hold 6–8 birds, so the program may need to be continued for a week or more to trap out the ﬂock. For humane reasons, water must also be provided in the traps. After trapping, birds need to be removed and relocated miles/kilometers away from the trap sites. The alternative is to take them to an isolated site and dispatch them humanely by shooting them with a pellet gun. In any case, such actions must be done in areas where it is legal to do so, and certainly out of view of the public. In some situations—for example, in a high-ceilinged building infested by sparrows—trapping with mist netting may be the only practical solution. Because mist netting is normally used only by research scientists or by personnel of the U.S Fish and Wildlife Service (USFWS), purchasing such netting is highly restricted and must be done with the ultimate permission of the USFWS (because mist netting is virtually invisible to birds, special precautions are taken to prevent it from being used illegally). The net, 23–49 ft (7–15 m) high by 33–66 ft (10–20 m) wide, stretched between poles, is placed in what © 2003 by Marcel Dekker, Inc.

have been observed to be bird ﬂight routes in the facility. Be advised that the netting becomes easily entangled and requires skill and patience to use. At this point, one can wait for the birds to ﬂy into the netting or one can attempt to drive the birds into it. Birds trapped in such a manner must be carefully extricated and then released well away from the building. This netting cannot be used outdoors without permission of the USFWS. Another method for trapping individual sparrows or starlings is to install rodent glue boards in the facility. Prebait covered glue boards with a food favored by the bird species of interest. For sparrows bread or popcorn can be used, while for starlings grapes or raisins are attractive. After 24 hr of prebaiting, the paper covering the glue is removed. Stuck birds should be removed with mineral oil or salid oil and released away from the building. Trapping large numbers of birds on a rooftop or other ﬂat surface can occasionally be accomplished by use of netting shot from a small cannon designed for this purpose. This method, for use only by professional bird management companies, may require approval from the USFWS. The netting, approximately 24.6 ⫻ 49 ft (7.5 ⫻ 15 m), is shot from the cannon in a projectile that carries the netting over the birds and drops it. After the birds are carefully removed from the netting, they are carried to a distant site and released. D. Avicides Avicides are becoming more and more restricted in their use, and the number of registered avicides approved by the Environmental Protection Agency (EPA) continues to decline year after year. Virtually all uses of toxic bird perches, for example, formerly widely used for starlings and sparrows, have had their registrations cancelled by the EPA. The number of registered products containing the most widely used avicide, 4aminopyridine, is fewer than just a few years ago. Those products that are still registered are labeled for use only in a diluted strength that makes most birds sick but does not kill them. This product is typically used in conjuction with bait containing corn or other feed attractants. Birds that consume this toxicant generally become distressed and disoriented with 30–60 min, often dropping to the ground and making distressed sounds and movements. The noises, as well as the appearance of affected birds, generally frighten away other birds in the area, particularly pigeons. Needless to say, pigeons that ﬂy in a drunken fashion and drop out the sky in a public place can cause a huge public relations problem. This type of product must be used very discreetly, preferably before or after business hours or on weekends. A product speciﬁcally for starlings, 3-chloro-p-toluidine hydrochloride, is a pellettype bait that kills slowly over 2–3 days and has no secondary poisoning effects. It kills only a few selected species of birds, which, however, also includes chickens, turkeys, or other poultry. Strychnine-laced bird control products can still be used in very limited situations, but most of these products will likely be phased out as their registrations expire. Those strychnine products still in current use have limited applications, mainly in agricultural settings. They are highly and rapidly toxic to birds of all species, as well as other animals. Moreover, they are well known for causing secondary poisoning effects in nontarget animals. Consequently, the labels for these products specify that they are restricted use products (applied only by certiﬁed pesticide applicators) that may be used only during the winter. Use of this bait should only be undertaken after consultation with the USFWS. © 2003 by Marcel Dekker, Inc.

E.

Shooting

When all else fails, shooting may be undertaken in very restricted circumstances. Such a program is usually initiated when small numbers of birds are in indoor food areas and must be eliminated quickly and when other methods are unlikely to succeed. Prior to starting such a program, police and local authorities must be consulted to ensure that shooting is not a violation of local ordinance. Shooting should be undertaken with a pellet riﬂe using a heavy pellet so that a quick kill is obtained. A skilled shooter should be used, one who can kill birds outright without wounding them. Once a program is begun, it must persist until all birds are either shot or depart the area. In some outdoor settings, a 0.22 gauge riﬂe or 0.410 shotgun can also be used. However, these are more apt to cause concerns for authorities. When employing a shooting program, bear in mind that the relief obtained is generally quite temporary, and birds will soon reappear if the conditions that attracted birds to the area in the ﬁrst place are not eliminated. F.

Biological Control

Although this method is seldom used, except at airports or large military bases, it can be quite effective. The method requires the employment of a falconer and trained peregrine falcons. Once falcons are observed by other birds, the pest birds generally leave quickly, with very few or no birds having to be killed. This method is quite expensive and may require a falconer to be present for up to a week or more to prevent new ﬂocks of pest birds from coming in to take advantage of the territories vacated by the departed ﬂocks.

VIII. SUMMARY Pest management of birds around food processing plants can be one of the most daunting challenges facing food production plant managers. A pest bird problem is often ignored until it becomes a critical issue and health inspectors threaten to close the plant. Unfortunately, rectifying such situations often requires much longer than the immediate solution the plant manger hopes for. Problems of poor sanitation and structural defects that make buildings attractive to birds are difﬁcult to ﬁx; but without ﬁxing these deﬁciencies many bird management methods work slowly or poorly. A good bird management program involves learning about the pest bird, its biology, and its behavior. Therefore, plant managers should engage the services of bird management professionals early on, rather than attempting makeshift ﬁxes to solve their problem. The best solutions for bird infestations are those that are well grounded in detailed knowledge of bird behavior, are painstakingly applied, and lead to permanent reductions in pest populations. Additionally, plant managers are generally not knowledgeable about federal, state, and local laws and regulations pertaining to birds and bird control. What appears to be a simple solution can result in killing songbirds or other protected species, which in turn can lead to a public relations disaster, a severe ﬁne, or worse. The successful program, which usually involves integrating several complementary approaches, is best achieved by using a professional bird management company. While these companies are few in number and sometimes expensive, the results are nearly always worth the costs, especially if you wish to avoid bad publicity from environmental groups and news media. © 2003 by Marcel Dekker, Inc.

REFERENCES 1. National Pest Control Association. Bird Management Manual. Dunn Loring, VA: National Pest Control Association, 1982. 2. USDA-APHIS. ADC assistance with waterfowl. United States Department of Agriculture, Animal and Plant Health Inspection Service ADC Factsheet, Annapolis, MD, 1995. 3. GW Bennett, JM Owens, RM Corrigan. Truman’s Scientiﬁc Guide to Pest Control Operations, 4th Ed. Duluth, MN: Advanstar Communications, 1988, pp 333–351. 4. RE Marsh, WE Howard, Pigeon control—a review of the options. Pest Control Technology, March: 68–78, 1991. 5. J Chin, ed. Control of Communicable Diseases Manual, 17th Ed. Washington, DC: American Public Health Association, 2000, pp 60–62, 296–299, 405–407, 440–444, 500–503. 6. G Mehta. Aspergillus endocarditis after open-heart surgery: an epidemiological investigation. J Hospital Infections 15:245–253, 1990. 7. CW Emmons. Annotations, the birds. Lancet 928, 1963. 8. RJP Thearle. Urban bird problems. In: RK Murton, EN Wright, eds. The Problems of Urban Birds. Symposia of the Institute of Biology, No. 17, 1967, pp 181–197. 9. HD Newson. Medically important anthropods. In: GW Hunter, JC Swartzwelder, DF Clyde, eds. Tropical Medicine, 5th Ed. Philadelphia: WB Saunders, 1976, pp 701–782. 10. WB Herms, MT James. Medical Entomology, 5th Ed. New York: Macmillan, 1961, pp 87– 120. 11. WD Fitzwater. How to control house sparrows. Pest Control Technology, April: 60–70, 1990. 12. W. Ebeling. Urban Entomology. Los Angeles: The University of California Press, 1975. 13. RE Marsh, WE Howard. Vertebrate pests. In: A Mallis, ed. Handbook of Pest Control, 7th Ed. Cleveland, OH: Franzak and Foster, 1990, pp. 771–831. 14. CA Faanes, C Vaughn, JM Andrew. Birders and U.S. federal laws. Birding 24(5):299–302, 1992. 15. National Pest Management Association. Addressing pest management concerns. Pest Management 5(4):15–21, 1986. 16. FJ Baur, WB Jackson. Bird Control in Food Plants. St. Paul, MN: The American Association of Cereal Chemists, 1982, pp 26, 27, 55. 17. GW Bennett, JM Owens, RM Corrigan. Truman’s Scientiﬁc Guide to Pest Control Operations, 5th Ed. Duluth, MN: Advanstar Communication, 1997, p. 366. 18. RE Marsh, RM Timm. Vertebrate pests. In: A. Mallis, ed. Handbook of Pest Control, 8th ed. Cleveland, OH: Mallis Handbook and Technical Training Company, 1997, p 998. 19. Urban ecosystem management: birds. The IPM Practitioner 3(3):2–3, 1981. 20. DM Hammershock. Ultrasonics as a method of bird control. U.S. Flight Dynamics Lab. Rpt. WL-TR-92-3033, Wright–Patterson Air Force Base, OH: Air Force Systems Command, 1992.

© 2003 by Marcel Dekker, Inc.

21 Stored-Product Insect Pest Management and Control FRANKLIN ARTHUR U.S. Department of Agriculture, Manhattan, Kansas, U.S.A. THOMAS W. PHILLIPS Oklahoma State University, Stillwater, Oklahoma, U.S.A.

I.

INTRODUCTION

Insect pest management and control is a serious concern for food processing and milling facilities. Contamination of products can have direct economic consequences either through damage and quality deterioration or intangible losses associated with customer dissatisfaction. In the past, most insect control programs at food plants were heavily dependent upon insecticides, but in recent years the number of insecticidal compounds that can be used to control insects inside and around food plants has been severely curtailed. New regulatory requirements for current insecticides, consumer preferences for reduced chemical use, and the high costs of developing and registering new replacement insecticides have all contributed to this decline. The concept of integrated pest management (IPM) was extensively developed and discussed during the latter portion of the 20th century. Now it is being promoted as the model for controlling insects in most production agricultural systems [1]. Integrated pest management is also being advocated for stored bulk grains [2–5]. However, this approach becomes more difﬁcult as agricultural products move from production areas to storage facilities and then to the processing and milling arenas. The risks of contamination, infestation, and consumer complaints, and the value and vulnerability of the products, often combine to produce what amounts to a zero tolerance for insects and damage. Although products can certainly become infested after leaving the food plant as they move through © 2003 by Marcel Dekker, Inc.

distribution chains and marketing channels, the manufacturer often receives the blame for contaminated products. Many aspects of traditional IPM programs are applicable for food plants, but others may not be economically feasible. When discussing IPM, it is important to relate the concepts to the particular pest management system that is being addressed, for IPM in one system may not be viewed in the same manner when it is applied to a different system. In this chapter, we describe and discuss components of the IPM approach as directed toward insect control in food plants and processing facilities.

II. INTEGRATED PEST MANAGEMENT The origin, historical development, deﬁnitions, and practical applications of IPM have been described in a recent review [1]. Common elements among most deﬁnitions of IPM include decision support for implementing insect control strategies, cost/beneﬁt analyses, impacts of multiple pests, and recognition of single and multiple control tactics integrated into a systems approach. The concept of IPM was primarily developed by ﬁeld crop entomologists [6], and many programs for ﬁeld crop pests have emphasized an economic injury level (EIL) and an economic threshold (ET), with extensive scouting and sampling to determine when the ET has been exceeded [7,8]. The concept of monitoring to determine the extent of insect infestations and the use of multiple controls is also emphasized when discussing IPM for stored grains. As ﬁeld crops such as wheat and corn are harvested and placed into storage, there are a number of factors that must be considered when discussing IPM strategies [4]: 1. 2.

3.

4. 5.

The large size of bulk storage facilities increases the difﬁculty and complexity of sampling and monitoring. Risks associated with insect infestation and damage are more serious in stored grain compared to ﬁeld crops because stored grain cannot compensate for insect damage through increased growth or other physiological responses. Also, stored grain is being moved directly to the processing and manufacturing industry, where there is little tolerance for insects and insect damage. There is a serious limitation on the availability of insecticides that can be used to control insects in stored grain, as older chemical protectants are being removed from the market, and replacement products may not be as economical or as effective [9]. The use of traditional insecticidal protectants as grain is loaded into storage is decreasing. The economics of the system may not support the scouting and consulting services that are common for most ﬁeld and orchard IPM programs. There is a noticeable lack of clear action levels in stored-product IPM as compared to ﬁeld crops.

The difﬁculties in application of the IPM concept to stored grain can be compounded when this approach is being applied to food plants, processing facilities, and mills. In this system, there is essentially a zero tolerance for insects and contamination, especially with the risk of having infested products passing through the distribution system and reaching consumers. Although it may be easier to monitor insects within plants and mills compared to bulk grain, there are problems with interpreting the information from insect traps. There is limited involvement regarding an outside scouting and consulting industry, and most © 2003 by Marcel Dekker, Inc.

of the data pertaining to the extent of insect infestations are kept conﬁdential and private within a particular company. The use of IPM in ﬁeld crops is based primarily on monitoring to determine if there is an insect problem and selecting appropriate control strategies to correct that problem. The concept of IPM as currently practiced in bulk grain and other food processing facilities appears to emphasize a multiple-component approach based on preventing insect problems from occurring, in addition to implementing controls after a problem is detected. The multiple-strategy approach for bulk grains often involves a prebinning insecticidal treatment to disinfest storage bins, aeration to modify the storage environment after grain is stored, monitoring pest populations during storage, and fumigation with phosphine when necessary. In food plants and storage facilities, IPM can include but is not limited to sanitation, exclusion of insects, monitoring programs, fumigants and alternatives to those fumigants, and residual insecticidal treatments with conventional chemicals and new products. These components are broadly classiﬁed as either nonchemical management strategies or chemical management strategies. In this chapter we will review the various IPM strategies and components regarding stored-product insect control in food processing systems. We should note that our discussion primarily refers to food processing systems only, as opposed to raw bulk grains. Also, we are speciﬁcally discussing management for stored-product insects only. Management of cockroaches and structural insects (Chapter 19), birds (Chapter 20), and mammalian pests (Chapter 18) are covered elsewhere in this book. III. NONCHEMICAL MANAGEMENT STRATEGIES A. Design Modiﬁcations Food plant design and engineering modiﬁcations for pest exclusion are covered elsewhere in this book and in an excellent treatise on the subject [10]. Good design includes good site selection and location, minimizing voids, wall spaces, cracks and crevices, and other hidden or restricted areas that can harbor insects and other pests, constructing ﬂoors that are easy to clean, providing for removal of accumulated material, and using manufacturing equipment that can be easily cleaned to prevent the build-up of food sources that can promote infestations. Other design considerations include installation of outside lighting away from buildings, good separation and structural isolation of raw materials, and separate areas for processing, packaging, and ﬁnished product storage [10]. B. Insect-Resistant Packaging Insect-resistant packaging (see Chapter 25) is an extremely important control strategy that is often overlooked when considering nonchemical control or exclusion techniques. Stored-product insects vary in their ability to infest packages. They can be broadly classiﬁed as penetrators, capable of boring through packaging materials, and invaders that can enter through seams or openings [11,12]. However, under certain conditions, invaders may be able to penetrate a package. Also, different life stages of particular species may vary in their ability to enter packages [12,13]. Different packaging ﬁlms may vary in their ability to prevent insect entry. For example, polyvinyl chloride polymer ﬁlms are less resistant than polypropylene ﬁlms [14]. Methods have been developed to quickly evaluate the effectiveness of new packaging materials [15]. Proper selection and utilization of materials will protect packages while © 2003 by Marcel Dekker, Inc.

they are stored at the food plant before they are shipped and may also ensure protection of packages as they move through the marketing channels. New research has shown the potential for incorporation of natural chemical repellents into packaging material and new glues and sealing methods to improve the structural integrity of insect-resistant packaging [16]. C.

Sanitation

Sanitation as deﬁned for the food processing and milling industries is often described by a combination of approaches, such as cleaning and elimination of conditions that can cause contamination, pest control operations, and maintaining a safe and healthy working environment for employees [17]. Training manuals and management guides for industry usually include descriptions of insect pests and guidelines for the use of insecticides [16,18,19]. In our discussion of sanitation, we focus on cleaning operations and how they can affect occurrence of insect pests and the efﬁcacy of insecticides used to control these pests. Although the importance of sanitation is continually addressed in the development of management programs for bulk-stored grains and oilseeds, there are few published reports that document direct quantitative effects of sanitation. The effects appear to be more directly related to improvements in other aspects of the management program, such as the efﬁcacy of insecticides. In one Australian study conducted in stored wheat, hygiene and cleaning practices by themselves had little effect on insect populations, but they greatly improved the efﬁcacy of protectant insecticides [20]. Similar results were noted in studies with in-shell peanuts. Residues of pirimiphos-methyl would become concentrated in foreign material such as dirt, twigs, sticks, and grass, and overall degradation of the insecticide was accelerated compared to cleaned peanuts [21]. Insect populations were also signiﬁcantly greater in peanuts containing foreign material versus those in cleaned peanuts [22,23]. There are also few published reports of studies related to the food plant and milling industries that document direct effects of cleaning. However, the presence of food materials and extraneous trash may have a signiﬁcant impact on the efﬁcacy of insecticides. In studies where red ﬂour beetles (Tribolium castaneum) were provided with ﬂour after shortterm exposures on concrete treated with cyﬂuthrin wettable powder (WP), survival dramatically increased compared to beetles that were not given food [24]. The presence of accumulated ﬂour also appeared to accelerate inactivation of cyﬂuthrin residues on concrete. When beetles were put on extraneous substances such as sawdust and wheat kernels, survival was increased relative to beetles put on clean substrates [25]. Survival of red ﬂour beetles and confused ﬂour beetles (Tribolium confusum) was greatly enhanced when beetles were given ﬂour either while they were directly exposed to the inert dust diatomaceous earth or after they were exposed for short time intervals to the dust and held for deﬁned time periods after exposure [26]. Concentrations of extraneous materials within food plants, especially food sources, could form barriers so that insects cannot come into contact with residues on treated surfaces, provide insects with a means of removing insecticide particles, or increase survival through the nutrition provided by the food source. These sites may become refuge areas that can allow insects to escape and evade exposure when insecticides are targeted to speciﬁc areas [27,28]. Many of these refuge sites could be eliminated through a regular program of inspection and cleaning. Industrial plants often contract with outside sources © 2003 by Marcel Dekker, Inc.

to provide regular inspections and sanitation audits so that management can be alerted to potential problem sites within the food plant. One ﬁnal aspect of sanitation involves accurately recording customer complaints and tracking returns so that problems that occur after products have left the food plant can be identiﬁed and corrected. In most cases, food manufacturers and processors are held responsible for contaminations that occur during distribution and marketing channels. Consumers tend to address their concerns to the original source of the product, usually the manufacturer. A tracking program could enable manufacturers to identify the speciﬁc locations where problems are occurring and implement corrective actions. D. Monitoring Pest monitoring is one of the cornerstones of an effective IPM program. Only through monitoring can the food plant managers know the insect species, relative abundance, and the distribution of insect populations within the facility. This information is essential for making pest management decisions. Pest monitoring can be carried out as part of the routine sanitation plan in a food plant and should integrate personnel from pest control, receiving, production, packaging, and shipping. Monitoring can involve active inspection or sampling for pests or utilize monitoring tools such as traps to detect and assess insect pest populations. 1. Visual Inspections Visual inspections of a food plant for insect pests, whether conducted on a formal or informal basis, should be part of the sanitation or pest manager’s work routine. Facilities that process cereal grains or other dry food products such as baked goods and confectionaries will be vulnerable to infestation by stored-product insects. Guidelines have been developed for conducting walk-through inspections of such plants to detect insects in predictable situations [18]. Debris accumulated from ﬂoor sweepings, vacuum cleaning, and sifting equipment should be inspected for insects. Elevator boots and voids under the boots should be thoroughly examined, as insects can accumulate and breed in food in the ‘‘dead space’’ that is not contacted by the buckets. Ledges, shelf tops, machinery tops, tops of exposed structural members, and other high surfaces that are not easily cleaned should be regularly inspected for insects. Insects often accumulate on windowsills and other surfaces near windows because of the natural tendency of insects to ﬂy toward light. A vigilant inspector will learn the areas of the plant that are most likely to reveal insect activity and focus on those during an inspection. 2. Traps Insect traps are monitoring tools that capture insects over time and thus provide the manager with speciﬁc information about insect activity. Trap-catch data are more readily acquired than data from visual inspections. Most living insects are not easily observed during sanitation inspections because they are hidden and therefore are not easy to see. Regular monitoring using several insect traps of different types at multiple locations throughout a facility can yield information regarding the presence of speciﬁc insect species, relative changes in numbers and species composition over time, and the location of insects and their relative abundance at different locations. Various trapping devices are available for use, with some being more appropriate in certain situations than others. © 2003 by Marcel Dekker, Inc.

a. Glue Boards. Glue boards, sticky cards, or ‘‘blunder’’ traps are typically ﬂat pieces of stiff card stock or ﬁber board coated with a sticky material (Fig. 1A). Glue boards have been used for years by the pest control industry to capture and monitor rodent pests [29], but they also have good utility for monitoring insects. Small sticky cards have proven effective for monitoring cockroaches for pest management purposes [30]. Glue boards without attractants are not speciﬁc and will capture any insect that blunders into them. Glue boards are typically placed on the ﬂoor at a wall junction so that insects walking along the wall can be trapped as they cross the board. Some insects, such as the red ﬂour beetle, avoid stepping onto a sticky surface [31], so it is important to note that insect species differ in their response to traps. Glue boards represent the traps of least sensitivity among the available designs, but they are inexpensive and easy to use, especially in concert with a rodent control program, so they should be checked for stored-product insects. b. Light Traps. Light traps, equipped with sticky or electrocuting surfaces, attract ﬂying insects to an artiﬁcial light source. Many insects, including stored-product insects, will ﬂy toward light in the visible-to-ultraviolet range of the electromagnetic spectrum [32], thus most light traps are equipped with a ﬁltered ultraviolet (‘‘black’’) light (Fig. 1B). Although the light is an insect attractant, light traps are relatively nonspeciﬁc and are useful for any ﬂying insects that may be sensitive to the wavelengths emitted from a particular trap design. The original reason for using light traps in structural pest control was, and still is in most cases, to trap and monitor houseﬂies (Musca domestica) and other ﬂies that carry ﬁlth to food. Thus, light traps are used in restaurants, food services, and other facilities that prepare food for immediate consumption.

Figure 1

(A) Sticky glue card that acts as a blunder trap for pedestrian insects and rodents. (B) Light trap. Insects are attracted to ultraviolet lights, are disabled by the electrocuting grid behind the lights, and then fall into a receptacle in the bottom of the trap. (C) Sticky trap for ﬂying insects; such a strap is typically baited with the sex pheromone of a moth or beetle. (D) Pitfall trap for walking insects. A pheromone lure attracts insects to the vicinity of the trap; responding insects climb the inclined wall and fall into the pit where they are trapped in oil.

© 2003 by Marcel Dekker, Inc.

However, light traps are very useful for monitoring stored-product insects in food processing plants. The higher cost of light traps relative to other traps, and their relatively large size and need for a power supply, will relegate their deployment to just a few key locations throughout a plant. Electrocuting-type traps are not recommended for monitoring purposes. Because responding insects typically explode into many pieces upon contact with the electrocuting grids, they become impossible to identify and count. Nonexploding electrocuting light traps, and those equipped with a sticky trapping surface, are preferred because whole insects can be identiﬁed and counted. c. Pheromone Traps. Pheromone traps are the most species-speciﬁc and sensitive traps available for monitoring insect pests. A pheromone is a chemical signal recognized among members of the same species. These traps utilize a synthetic chemical copy of the natural attractant of a given species to capture insects [33]. Synthetic pheromones are formulated into slow-release dispensers. The volatile attractants are slowly evaporated from a lure and thus are effective for several weeks or months. Because pheromones are species-speciﬁc signals, they attract only members of the target species, or sometimes those of closely related species, that use the pheromone in the natural context. They are useful for monitoring a speciﬁc pest for which the pheromone is available. Because sex and aggregation pheromones are strong attractants for insects seeking out mates or breeding sites, pheromones traps can attract and detect the presence of insects whose population might be at a relatively low level and probably would not be detected by other means. Although pheromones have been chemically identiﬁed for approximately 40 species of stored-product insects, pheromone traps and lures are commercially available for just the key pests [5,34–36]. Traps and lures are available and widely used for the Indianmeal moth (Plodia interpunctella), the cigarette beetle (Lasioderma serricorne), the warehouse beetle (Trogoderma variabile), and the red and confused ﬂour beetles. Pheromones for some of these species are also attractive to closely related species. The Indianmeal moth pheromone attracts some other storage moths such as the almond moth (Cadra cautella) and the Mediterranean ﬂour moth (Ephestia kuehniella). The warehouse beetle pheromone attracts other beetles in the genus Trogoderma. Pheromones are typically sex speciﬁc or sex biased in the insects they attract. For example, the pheromones for moths, cigarette beetles, and warehouse beetles are synthetic mimics of the female-produced sex attractant, thus they attract only males. The maleproduced, aggregation pheromone of Tribolium spp. attracts both sexes, but more females than males. Pheromone traps come in various designs [33], most of which are intended for a particular species or type of pest. The two fundamental designs are either for ﬂying insects or for crawling insects. Sticky traps are commonly used for ﬂying moths and beetles, capturing responding insects on a protected sticky surface (Fig. 1C). Sticky traps are relatively inexpensive and easy to use, but are easily fouled with dust and debris or become ﬁlled with insects and need replacement within a few weeks or month. Nonstick traps for ﬂying insects are reusable but more expensive than sticky traps, and they incorporate a funnel or landing surface for the insects and a collection reservoir for trapped insects. Crawling insects can be trapped with various designs of pitfall traps (Fig. 1D) that are placed on surfaces such as ﬂoors or shelves. Insects may ﬂy or crawl to the vicinity of the pitfall trap and then walk into the trap and fall into some sort of © 2003 by Marcel Dekker, Inc.

trapping reservoir. The best traps for pest monitoring are those that are easy to use and have a proven reputation for effectiveness. One misconception about pheromone traps is that a pest population can be controlled by deploying these traps—this is not true for most situations. Traps usually attract only a small percentage of the population that is within the effective range of the trap. Also, female-produced sex pheromones attract only males; the females that lay eggs and perpetuate the infestation are not affected. Since males of many insect species will mate with multiple females, any males that are not trapped can easily contribute to the production of a subsequent generation of pests [34]. New methods are being researched for using pheromones in pest suppression, but current uses of pheromone traps are best used only for monitoring purposes [33]. d. Trapping Strategies. Pest managers must be able to use information from traps to assist in pest management decisions. Simply capturing one pest insect at one time in a single trap tells the manager nothing except that a particular species is present. Multiple traps must be deployed in various locations and they need to be checked many times, usually on a regular, ongoing basis according to a set schedule. Pheromone traps or glue boards should be deployed in all the major areas of a plant or warehouse, usually along walls or shelves, with two or more traps per area (Fig. 2). Light traps may not be used as often as other traps (because of the expense), but at least one light trap per large area would be helpful. Light traps should be located away from outer doors so that insects are not attracted into the plant from the outside. Traps should be checked weekly or biweekly and the species and number of insects recorded.

Figure 2 A contour map showing the distribution of male adult warehouse beetles (Trogoderma variabile) based on captures in pheromone-baited traps over a 1-week period in a food warehouse. Trap locations are designated by asterisk and the darker shades of contour indicate higher insect numbers. Concentrations of insects are depicted in the lower right of the map near some machinery and in an inner room at the upper left. (Map and data are courtesy of Dr. James Campbell, USDAARS; we deeply appreciate his contribution.) © 2003 by Marcel Dekker, Inc.

A pattern of insect activity may become evident initially, with some areas having more insects than others, and such a pattern may be corroborated upon subsequent checks of the traps. Consistent relatively high numbers in one area should alert the manager to do a thorough inspection of that area, or place a higher density of traps in the area, in order to localize the infestation. Once infested products, machines, or other locations are identiﬁed, the infestation can be neutralized by sanitation, removing or destroying infested material, or targeted applications of insecticide. e. Data Analysis. A recent development in the use and interpretation of trapping information in the food and pest control industries is the analysis of trap data on computer spreadsheets and the visualization of trap data with geographic information system (GIS) software [30,37]. Services are now available in which each trap in a facility is equipped with a bar code so that its identity and location can be logged on a portable computer via a bar code reader. When checking traps, a service technician can read the bar code into a handheld computer, entering the trap catch data for the trap, and all data are recorded by date and trap identity. Upon return to the ofﬁce, trap data can be downloaded to a desktop computer where they may become part of a larger database for analysis of insect population trends. Additionally, trap data can now be analyzed with GIS software to generate maps that predict locations that may have high levels of insect activity and thus assist the manager in ﬁnding infestations or the source of trapped insects (Fig. 2) [30]. Whatever the method of analysis, it is clear that computer-aided summary and organization of trapping data will facilitate more knowledge of potential pest problems by managers than was ever possible prior to widespread adoption of traps in monitoring programs. An additional method for documenting the location of insect infestations is to monitor and record customer complaints or products returned because of insect infestation. For some companies, customer complaints may be the only means of detecting insect problems in products because the packaged goods rarely display problems in short-term storage after manufacture and before shipping. These infestations often develop in the marketing channels as the product is delivered to the consumer. Reports by customers that include production code numbers of infested packages allow the manufacturer to determine the origin and production date of the ﬁnished product, then track that material through their distribution system. Food manufacturers encourage information about infested products from customers by providing toll-free telephone numbers printed on packages and offering replacement product or other in-kind compensation for customers’ call-in complaints. E.

Temperature Manipulations

Cold treatments and heat treatments have both been used to either prevent infestation of stored products or to eliminate existing infestations [38]. At extreme low or high temperatures, stored-product insects can be killed, and reproduction and development can be curtailed at more moderate high and low temperatures. The optimal range of development for most stored-product insects is about 22 to 35°C, depending on the individual species, and reproduction and development usually ceases at temperatures below 15°C [39,40]. 1. Cold Treatments Cold temperature treatments to disinfest entire warehouses and processing plants may be appropriate only in extreme northern climates where outside temperatures are cold enough to kill insects if this ambient air can be brought into a facility. However, there is always © 2003 by Marcel Dekker, Inc.

a danger that this cold air could have a negative impact on equipment inside the building. Small-scale treatments using cold temperatures to kill insects have been used in the dried fruit and tree nut industries and in specialty organic markets [38]. However, the more common use of cold temperatures is to prevent infestations from occurring by maintaining ﬁnished products in a low-temperature environment of 15°C or less. 2. Heat Treatments The upper thermal heat limit that causes death of most stored-product insects is in the range of 50 to 60°C (120 to 130°F) [40]. The idea of using heat to control insects inside mills is not new [41,42], but today there is renewed and expanded interest in using this technology to control insects [10]. Heat is seen as an alternative to methyl bromide to disinfest mills and other structures [43]. However, because most of the actual applications and research are being done by private companies, the results of trials are not normally published in the public domain, except for general descriptions in trade journals. 3. Combined Treatments One new aspect of research with heat is to use the technology in combination with other control options to improve the effectiveness of heat treatments. As an example, ﬁeld and laboratory trials [44,45] have shown that a combination of heat with diatomaceous earth (DE), a natural product, may be an effective control strategy. Because the DE imposes an added stress on the insects, a somewhat lower temperature matches the kill rate of a higher temperature without DE. There is potential to expand this concept with other insecticides, particularly with pyrethroids that do not degrade at high temperatures.

IV. CHEMICAL MANAGEMENT STRATEGIES The number of available insecticides in the United States that can be used to control insects in bulk-stored grain has declined in recent years, with few new products replacing them, and this trend will continue in the future [9]. The same trend is also occurring for insecticides that can be used in and around food plants, processing mills, and food warehouses. There are many reasons for this decline, but there are several which should be emphasized. First, the cost of developing and registering new conventional insecticides can approach 60 million U.S. dollars [9], and this ﬁgure will undoubtedly increase with each passing year. The stored-grain and food-manufacturing industries are relatively minor markets compared to ﬁeld crops. There is simply little economic incentive to develop new products. Second, new regulations and laws such as the 1996 Food Quality Protection Act (FQPA) and the interpretation of those laws by the Environmental Protection Agency (EPA) could lead to the elimination of many organophosphate and carbamate insecticides. New toxicological studies will be required to reregister these chemicals, but it is very unlikely that the chemical companies will invest the huge amount of money required to provide the necessary data when the markets for these are small and unproﬁtable. Third, many insect species have developed resistance to the older organophosphates, such as malathion, that were heavily used in the past by the food manufacturing industry. Numerous studies have documented extensive resistance to malathion in populations of stored-product insects throughout the world [46]. © 2003 by Marcel Dekker, Inc.

A. Fumigants One of the biggest challenges to the processing, milling, and food plant industries is the impending loss of the fumigant methyl bromide, scheduled for complete reduction and phase-out in the United States and most other developed countries by 2005. Several ‘‘alternatives’’ to methyl bromide have been identiﬁed, including, but not limited to, sanitation, improved monitoring and surveillance, surface insecticidal treatments, crack and crevice treatments, inert dusts, modiﬁed atmospheres, heat treatments, and several potential fumigants [43,47]. Currently, there are no fumigants registered that can replace methyl bromide for rapid disinfestation of infested products. Sulfuryl ﬂuoride is toxic to stored-product pests [48,49], but it requires long exposures to kill insect eggs. Sulfuryl ﬂuoride may have the best potential for registration in the United States to control insects inside food milling, processing, and storage facilities. However, as of this writing, it has not been registered. Hydrogen phosphide gas, or phosphine, is the only fumigant registered for food plants besides methyl bromide. Phosphine requires more time to kill than methyl bromide and it can be damaging to metals and electronics [50]. Because of the limited inventory of insecticides and options available for direct control of insect pests in food facilities, it is also important to emphasize the integrated aspects of insect pest management. This includes a discussion of physical, biological, and environmental factors that can affect the efﬁcacy of insecticides when they are used in management programs. B. Insecticide Treatments 1. Surface Treatments Versus Crack and Crevice Treatments a. Surface Treatments. Surface treatments are those insecticides that can be applied to large areas within a facility. Label directions usually give a speciﬁc amount or volume of insecticide mixed in a given volume of water to cover a deﬁned area. For example, label directions for cyﬂuthrin, a pyrethroid insecticide, specify 9 or 19 g of the wettable powder (WP) formulation or 8 or 16 mL of the emulsiﬁable concentrate (EC) formulation in 1 gallon of water to cover 1000 ft 2. Label directions for a registered EC formulation of hydroprene (Gentrol  ), an insect growth regulator (IGR), are also given in volume quantities. There are several registered formulations of the inert dust diatomaceous earth. Each label states a certain amount or range of product per unit area, usually given as either square feet or meters. These are currently the most common insecticides that are used as general surface treatments. Malathion is still labeled as a surface treatment, but use of this product has diminished considerably in recent years. b. Crack and Crevice Treatments. Label instructions for products labeled as crack and crevice or spot treatments often direct the user to make up a solution with a certain percentage of active ingredient, and then to shoot the spray into the crack or void space. Sometimes the insecticide can be used as a spot treatment to a small area. As an example, the label wording may deﬁne the spot as 2 ft 2 or less, and there may be a restriction on the total number or area of ‘‘spots’’ within a facility. Some crack and crevice treatments can be applied to outside surfaces of a facility; here larger unit areas can be treated than would be the case indoors. © 2003 by Marcel Dekker, Inc.

Several insecticides are currently labeled for use as crack and crevice or spot treatments, but many are the older organophosphate and carbamate insecticides that could be impacted by the FQPA. As always, before applying an insecticide, managers must comply with label instructions, ensure that the target insect pests are listed on the label, and ensure that products are applied as speciﬁed. 2. Space Treatments There are several aerosol products labeled for use inside food plants and warehouses, and each may have restrictions for use. Some labels may state application as a space treatment only to empty facilities, require users to cover food prior to application, or specify an aeration and venting period after the application is complete. They can be dispensed by timed application equipment in the headspaces of storage facilities. Label directions for these insecticides specify application of a given amount of insecticide within a speciﬁc space usually given as square feet or meters. Again, label directions must be followed when applying insecticides as a space treatment. 3. Fumigants and Controlled Atmospheres We have already mentioned the scheduled phase-out of methyl bromide, the most common fumigant treatment inside postharvest structures. The grain fumigant phosphine cannot normally be used inside structures because of its corrosive effects on metals [51]. New formulations and mixtures are being developed to combat this problem. Hermetic storage, which is a type of modiﬁed and controlled atmosphere, was used in ancient times to control insects in food. Today, the controlled-or modiﬁed-atmospheres technique is one of the most extensively researched areas in postharvest insect control in raw grains and in structures. There is a large volume of published literature regarding the effects of modiﬁed atmospheres on stored-product insects [51,52]. Most of the new advances in application technology are not published in scientiﬁc journals but are found instead in proceedings from various research conferences held on a regular basis, including the International Working Conferences on Stored-Product Protection and the recent Controlled Atmosphere and Fumigation conferences [52]. Most modern uses of modiﬁed atmospheres involve creating a low-oxygen atmosphere, usually by adding CO 2 or N 2 . Although modiﬁed atmospheres are known to have toxic effects on insect species, they are not extensively used on a widespread basis to kill insects in food plants because of the time and expense required for application, the need for extensive monitoring during a treatment, difﬁculties in application to the entire facility or building compared to other treatments, and potential contamination effects of CO 2 [51]. In addition, modiﬁed atmospheres can be toxic to humans as well as insects [51]. However, there are areas where modiﬁed atmospheres, vacuum sealing, lowpressure treatments [53], and other similar methods may have potential for small-scale applications within a food plant, such as specialized chamber treatments before products are shipped to distribution centers. Given the lack of alternatives to methyl bromide and the continuing improvements in application technology for controlled atmospheres, there appears to be considerable potential for the increased use of modiﬁed atmospheres. 4. Future of New Products The emphasis on insecticides in the future will be on the development of reduced-risk, low-toxicity products. Because of the registration costs of new chemicals, it is likely than many of these newer products will be those that are exempt from tolerance requirements © 2003 by Marcel Dekker, Inc.

because registration costs will be lower for these chemicals [9]. Conventional chemicals will be developed ﬁrst for the more proﬁtable areas where insecticides are used on a regular and frequent basis, such as ﬁeld crop pest control and traditional urban programs for cockroaches and other human ﬁlth pests. Research will also be conducted on the various factors that affect the efﬁcacy of insecticides, with the goal of understanding how these factors affect control when insecticides are used in a management program. As an example, we will discuss several of these factors and how they have an impact on the response of insects to various insecticidal treatments. V.

FACTORS AFFECTING PESTICIDE EFFICACY

A. Surface and Substrate The surfaces and substrates to which liquid formulations of contact insecticides are applied often affect insecticidal efﬁcacy, especially when the applied treatment is supposed to have residual action. In general, insecticidal activity is reduced on porous surfaces such as concrete and wood compared to activity on nonporous surfaces [54–58]. Most interior ﬂoors of food plants and warehouses are made of concrete that, being alkaline, promotes hydrolysis of the active ingredient, thus further reducing residual activity [51]. Painting over porous surfaces often prolongs the active life of chemicals by forming a barrier and may also reduce hydrolysis on concrete [51,57]. B. Insecticide Formulation Wettable powder formulations are more persistent than the emulsiﬁable concentrates of most organophosphate and pyrethroid insecticides that are either currently used for insect control or have been tested in laboratory studies for control of stored-product insects [55,57]. In tests with the pyrethroid cyﬂuthrin, longer exposure intervals were required to give equivalent mortality levels of red ﬂour beetles and confused ﬂour beetles exposed on concrete treated with the EC versus the WP formulation [59]. However, the efﬁcacy of the EC formulation was improved by painting the concrete with a waterproof sealant prior to insecticide application [59]. There are many different formulations of diatomaceous earth that are commercially available for use inside food plants and warehouses, and there is considerable variation among these products [60,61]. The source of the DE and the physical characteristics of the formulation are among the factors that contribute to this variation. Methods have been developed to rapidly screen and assess different DE products [62]. However, caution should be exercised in interpreting the results of experimental studies; results obtained with one DE product may not be applicable to other products. C. Temperature and Relative Humidity The temperature and relative humidity at which stored-product insects are exposed to insecticides can have a signiﬁcant impact on the response of those species. In general, organophosphates increase and pyrethroids decrease in toxicity as temperature rises [63]. Studies with cyﬂuthrin and the red ﬂour beetle document this negative correlation with temperature [64]. Mixed results have been produced in studies where stored-product insects have been exposed at different temperatures to diatomaceous earth. Some studies © 2003 by Marcel Dekker, Inc.

document a negative effect at increased temperatures [61,65], while others show a positive effect [66]. Fumigants and modiﬁed atmospheres usually exhibit a positive increase in toxicity with increasing temperature [51,52]. Humidity effects are probably more important when using DE inert dusts, because toxicity of most DE products usually decreases as relative humidity increases [60,61]. In studies with both red and confused ﬂour beetles, longer time intervals were required to produce equivalent levels of mortality as beetles were exposed at increasing humidity levels [66]. Diatomaceous earth acts in part by causing water loss through disruption of the cuticular layer [67]. Therefore, increased exposure intervals are necessary to kill insects at higher humidities because water is lost at a slower rate. Although there are few published reports concerning the effects of relative humidity on the activity of IGRs, there is some evidence supporting a positive effect with humidity. When last-instar red and confused ﬂour beetle larvae were exposed on concrete treated with hydroprene, both morphological defects in adult and the percentage of arrested larvae increased with increases in humidity [68]. D.

Species Variability

The speciﬁc target pest or pests should be precisely identiﬁed as part of the management program. With all of the various insecticides that can be used in food plants, there may be considerable variation concerning the response of various stored-product insect species. In studies with DE products, Tribolium species and the lesser grain borer (Rhyzopertha dominica) appear to be more tolerant than rice weevils (Sitophilus oryzae) or sawtoothed grain beetles (Oryzaephilus surinamensis) [61]. Even closely related species can show considerable variation, and the order of susceptibility can change depending on the insecticide. The red ﬂour beetle is more tolerant than the confused ﬂour beetle to cyﬂuthrin [69,70], but the reverse is true for deltamethrin dust and diatomaceous earth [58,66]. Life stages of individual species can also vary in their response to an insecticide. Indianmeal moth larvae are particularly difﬁcult to kill with residual insecticides compared to adult moths or even stored-product beetles [71– 73]. The eggs and sometimes pupae are the life stages that are most tolerant to conventional fumigants [74,75] and to various controlled atmospheres [52]. VI. CONCLUSION In this chapter we developed the concept of integrated pest management as it relates to insect control in food plants and processing facilities. The various sections in this chapter emphasize different aspects of management and describe how a combination or multiple approach strategy may be the best way of viewing insect management for the future. The ecosystem approach is used to develop management programs for ﬁeld crops, and there are several studies that describe the bulk-grain storage system as an ecosystem [76–78], with inputs, processes, and likely outcomes depending on the interaction of these inputs and processes. Perhaps the same approach could be used to develop new management paradigms for the food manufacturing industries. REFERENCES 1. M Kogan. Integrated pest management: historical perspectives and contemporary developments. Ann Rev Entomol 43:243–270, 1998.

© 2003 by Marcel Dekker, Inc.

2. DE Evans. Stored products. In: AJ Burn, TH Coaker, PC Jepson, eds. Integrated Pest Management. London: Academic Press, 1987, pp 425–461. 3. BC Longstaff. The management of stored grain pests by non-chemical means: an Australian perspective. J Stored Products Res 30:179–185, 1994. 4. DW Hagstrum, C Reed, P Kenkel. Management of stored wheat pests in the USA. Integrated Pest Management Rev 4:127–142, 1999. 5. TW Phillips, RC Berberet, GW Cuperus. Post-harvest integrated pest management. In: FJ Francis, ed. Wiley Encyclopedia of Feed Science and Technology. New York: Wiley, 2000, pp 2690–2701. 6. VM Stern, RF Smith, R van den Bosch, KS Hagen. The integrated control concept. Hilgardia 29:81–101, 1959. 7. VM Stern. Economic thresholds. Ann Rev Entomol 18:259–280, 1973. 8. A Vandeman, J Fernandez-Cornejo, S Jans, BH Lin. Adoption of integrated pest management in U.S. agriculture. USDA-ERS Agriculture Information Bulletin 707:1–26, 1994. 9. FH Arthur. Grain protectants: current status and prospects for the future. J Stored Products Res 32:293–302, 1996. 10. TJ Imholte, TK Imholte-Tauscher. Engineering for Food Safety and Sanitation. 2nd Ed. Woodinville, WA: Technical Institute for Food Safety, 1999. 11. HA Highland. Insect infestation of packages. In: FJ Baur, ed. Insect Management for Food Storage and Processing. St. Paul, MN: American Association of Cereal Chemists, 1984. 12. MA Mullen. Keeping bugs at bay. Feed Management 48(3):29–33, 1997. 13. LD Cline. Penetration of seven common ﬂexible packaging materials by larvae and adults of eleven species of stored-product insects. J Econ Entomol 71:726–729, 1978. 14. TG Bowditch. Penetration of polyvinyl chloride and polypropylene packaging ﬁlms by Ephestia cautella (Lepidoptera: Pyralidae) and Plodia interpunctella (Lepidoptera: Pyralidae) larvae, and Tribolium confusum (Coleoptera: Tenebrionidae) adults. J Econ Entomol 90:1028–1031, 1997. 15. MA Mullen. Rapid determination of the effectiveness of insect resistant packaging. J Stored Products Res 30:95–97, 1994. 16. MA Mullen, JR Pederson. Sanitation and exclusion. In: B Subramanyam, DW Hagstrum, eds. Alternatives to Pesticides in Stored-Product IPM. Hingham, MA: Kluwer Academic, 2000, pp 29–50. 17. FD Hayman. Organizing and managing food plant sanitation. AOM Bulletin, March 1985. 18. R Mills, J Pederson. A Flour Mill Sanitation Manual. St. Paul, MN: Eagan Press, 1990. 19. SA Hedges, MA Lacey. Field Guide for the Management of Structure-Infesting Beetles. Cleveland, OH: Franzak and Foster, 1996. 20. GA Herron, AD Clift, GG White, GG Greening. Relationships between insecticide use, grain hygiene, and insecticide resistance in Oryzaephilus surinamensis (L.) (Coleoptera: Silvanidae) on grain-producing farms. J Stored Products Res 32:131–136, 1996. 21. FH Arthur, LM Redlinger. The effect of loose-shell kernels and foreign material on pirimiphosmethyl residues in stored farmers stock peanuts. Peanut Sci 14:59–61, 1987. 22. FH Arthur, LM Redlinger. Inﬂuence of loose-shell kernels and foreign material on insect damage in stored peanuts. J Econ Entomol 81:387–390, 1988. 23. FH Arthur. Effects of cleaning peanuts on insect damage, insect population growth, and insecticide efﬁcacy. Peanut Sci 16:100–105, 1989. 24. FH Arthur. Effects of a food source on red ﬂour beetle (Coleoptera: Tenebrionidae) survival after exposure on concrete treated with cyﬂuthrin. J Econ Entomol 91:773–778, 1998. 25. FH Arthur. Impact of accumulated food on survival of Tribolium castaneum on concrete treated with cyﬂuthrin wettable powder. J Stored Products Res 36:15–24, 2000. 26. FH Arthur. Impact of food source on survival of red ﬂour beetles and confused ﬂour beetles (Coleoptera: Tenebrionidae) exposed to diatomaceous earth. J Econ Entomol 93:1347–1356, 2000.

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27. G Barson. Laboratory assessment of the residual toxicity of commercial formulations of insecticides to adult Oryzaephilus surinamensis (Coleoptera: Silvanidae) exposed for short time intervals. J Stored Products Res 27:205–211, 1991. 28. PD Cox, DA Fleming, JE Atkinson, KL Bannon, JM Whitﬁeld. The effect of behavior on the survival of Cryptolestes ferrugineus in an insecticide-treated laboratory environment. J Stored Products Res 33:257–269, 1997. 29. SC Franz, DE Davis. Bionomics and integrated pest management of commensal rodents. In: JR Gorham, ed. Ecology and Management of Food-Industry Pests. Arlington, VA: Association of Ofﬁcial Analytical Chemists, 1991, pp 243–313. 30. JR Brenner, DA Fochs, RT Arbogast, DK Weaver, DE Shuman. Practical use of spatial analysis in precision targeting for integrated pest management. Am Entomol 44:79–101, 1998. 31. CW Doud. Monitoring the red ﬂour beetle, Tribolium castaneum (Herbst) (Coleoptera: Tenebrionidae) and other stored-product insects with traps in ﬂour mills. M.S. thesis, Oklahoma State University, Stillwater, OK, 1999. 32. DP Rees. Review of response of stored product insects to light of various wavelengths, with particular reference to design and use of light traps for population monitoring. Tropical Sci 25:197–213, 1985. 33. TW Phillips, PM Cogan, HY Fadamiro. Pheromones. In: B Subramanyam, DW Hagstrum, eds. Alternatives to Pesticides in Stored-Product IPM. Boston, MA: Kluwer Academic, 2000, pp 273–302. 34. TW Phillips. Pheromones of stored-product insects: current status and future perspectives. In: E Highley, EJ Wright, HJ Banks, BR Champ, eds. Proceedings of the 6th International Working Conference on Stored-product Protection. Wallingford, UK: CAB International, 1994, pp 479–486. 35. TW Phillips. Semiochemicals of stored-product insects: research and applications. J Stored Products Res 33:17–30, 1997. 36. CW Doud, TW Phillips. Activity of Plodia interpunctella (Lepidoptera: Pyralidae) in and around ﬂour mills. J Econ Entomol 93:1842–1847, 2000. 37. RT Arbogast, PE Kendra, RW Mankin, JE McGovern. Monitoring insect pests in retail stores by trapping and spatial analysis. J Econ Entomol 93:1531–1542, 2000. 38. CS Burks, JA Johnson, DE Maier, JW Heaps. Temperature. In: B. Subramanyam, DW Hagstrum, eds. Alternatives to Pesticides in Stored-Product IPM. Boston: Kluwer Academic, 2000, pp 73–104. 39. RW Howe. A summary of estimates of optimal and minimal conditions for population increase of some stored products insects. J Stored Products Res 1:177–184, 1965. 40. PG Fields. The control of stored-product insects and mites with extreme temperatures. J Stored Products Res 28:89–118, 1992. 41. DA Dean. Heat as a means of controlling mill insects. J Econ Entomol 4:142–158, 1911. 42. DA Dean. Further data on heat as a means of controlling mill insects. J Econ Entomol 6:40– 53, 1913. 43. T Batchelor. Montreal protocol on substances that deplete the ozone layer. Assessment of alternatives to methyl bromide. Methyl Bromide Technical Options Committee, United Nations Environmental Programme, 1998 (www.teap.org). 44. P Fields, A Dowdy, M Marcotte. Structural pest control: the use of an enhanced diatomaceous earth product combined with heat treatment for the control of insect pests in food-processing facilities. Leadership in the development of methyl bromide alternatives. Environmental Bureau, Agriculture and Agri-Food Canada and the U.S. Department of Agriculture, 1997. 45. AK Dowdy. Mortality of red ﬂour beetle, Tribolium castaneum (Coleoptera: Tenebrionidae) exposed to high temperature and diatomaceous earth combination. J Stored Products Res 35: 175–182, 1999. 46. B Subramanyam, DW Hagstrum. Resistance measurement and management. In: B Subrama-

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68. FH Arthur. Susceptibility of last-instar red ﬂour beetles and confused ﬂour beetles (Coleoptera: Tenebrionidae) to hydroprene. J Econ Entomol 94:772–779, 2001. 69. FH Arthur. Residual toxicity of cyﬂuthrin wettable powder against Tribolium confusum (Coleoptera: Tenebrionidae) exposed for short time intervals on concrete. J Stored Products Res 34:19–25, 1998. 70. FH Arthur. Residual studies with cyﬂuthrin wettable powder: toxicity toward red ﬂour beetles (Coleoptera: Tenebrionidae) exposed for short intervals on concrete. J Econ Entomol 91:309– 319, 1998. 71. FH Arthur. Pests of stored peanuts: toxicity and persistence of chlorpyrifos-methyl. J Econ Entomol 82:660–664, 1989. 72. FH Arthur. Susceptibility of ﬁfth-instar Indianmeal moth and almond moth (Leptidoptera: Pyralidae) to cyﬂuthrin residues on peanuts. J Entomol Sci 30:318–323, 1995. 73. FH Arthur. Residual susceptibility of Plodia interpunctella to deltamethrin dust: effects of concentration and time of exposure. J Stored Products Res 33:313–319, 1997. 74. BD Hole. Variation in tolerance of seven species of stored product Coleoptera to methyl bromide and phosphine in strains from twenty-nine countries. Bull Entomol Res 71:299–306, 1981. 75. CH Bell, N Savvidou. The toxicity of Vikane (sulfuryl ﬂuoride) to age groups of eggs of the Mediterranean ﬂour moth (Ephestia kuehniella). J Stored Products Res 35:233–247, 1999. 76. DW Hagstrum, WG Heid Jr. U.S. wheat marketing system: an insect ecosystem. Am Entomol 34:34–36, 1988. 77. FV Dunkel. The stored grain ecosystem: a global perspective. J Stored Products Res 28:73– 87, 1992. 78. NDG White. A multidisciplinary approach to stored-grain research. J Stored Products Res 28: 127–137, 1992.

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22 An Informal Look at Food Plant Sanitation Programs JERRY W. HEAPS General Mills, Minneapolis, Minnesota, U.S.A.

I.

INTRODUCTION

‘‘What, you want line downtime to clean?’’ Sound familiar? The objective of any food plant sanitation program is to have an ongoing, evolving plan to deliver a plant that is both pleasing to look at and economical to operate. This is also a plant that consistently is free of ‘‘pests’’ (e.g., insects, birds, rodents, undesirable microbes, allergens), produces wholesome products free of extraneous materials, and operates according to the letter of the law (the federal Food, Drug, and Cosmetic Act and a host of local and state regulations). Clean is clean. Sanitarians do not like to argue about degrees of sanitation or cleanliness. To these professionals and, one can say, for everybody who works in a food plant, sanitation should be a way of life. It is everyone’s responsibility to help keep a food plant clean and contribute to a successful sanitation program. In the competitive food plant arena, the days no longer exist that employees can rely on leaving their work areas dirty because ‘‘sanitation will come by later to clean it up.’’ Although this overview of food plant sanitation programs is cached in rather informal language, the subject itself is one of greatest seriousness and deserves the reader’s concentrated attention and action. II. BASIC ELEMENTS OF SANITATION Sanitation is the way people operate while they are at the plant, both inside and out. Many speciﬁc tasks are involved, including Complying with the current good manufacturing practices (GMPs) as outlined in the Code of Federal Regulations (21 CFR 110) © 2003 by Marcel Dekker, Inc.

Personal appearance and hygiene Aesthetic appearance of plant exterior and interior Stringent integrated pest management (IPM) Attention to the detail of sanitary design. Personal respect for the products being produced III. A CLOSER LOOK AT SANITATION Let’s take a closer look at each of these points. A.

Complying with GMPs

No one who makes food can argue with this—it’s the law! The GMPs are loaded with references to food plant sanitation, and compliance requires that ‘‘sanitation programs’’ be implemented. Examples follow. 1. Buildings and Grounds Subpart B, Buildings and Facilities, Paragraph 110.20, Plants and Grounds: Grounds ‘‘The grounds about a food plant under the control of the operator shall be kept in a condition that will protect against the contamination of food.’’ This means, but is not limited to, the following: Storing equipment properly (i.e., 18 inches up off the ground directly and in an area protected from the weather) Having a regular program to pick up waste and litter and cutting the grass and weeds (or use EPA-labeled herbicides where applicable) in the immediate plant vicinity to discourage the harborage of pests. Paving roads and parking lots to help eliminate dust/debris; preventing the pooling of water by having adequate drainage (pooled water may attract pests) Having adequate and properly operating systems for waste treatment and disposal carried out in a manner that prevents the contamination of areas where food is exposed. Many times food plants have an outside waste compactor area but no way to properly clean it. Install proper drainage plus hot/cold water of adequate pressure to facilitate year-round regular sanitation of this critical area. Cover or enclose it so rodents, birds, and insects are not attracted [see Part V of this book]. Paving outside rail yards. However, this is not the cheap. But have you ever tried to clean food debris from crushed rock? When it’s dry or wet? Anything can be done if you have enough time and labor. Most food plants today do not have these luxuries. In contrast to a crushed rock base, a smooth, ﬂat, hard surface is more easily and effectively cleaned. Additionally, such cleaning is much more likely to be done at the needed frequency. 2. Sanitary Operations a. General Maintenance. From Paragraph 110.35, Sanitary Operations, ‘‘Buildings, ﬁxtures and other physical facilities of the plant shall be maintained in a ‘sanitary’ condition and shall be kept in repair sufﬁcient to prevent food from becoming adulterated within the meaning of the act. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against the contamination of food, food-contact surfaces, or food packing materials.’’ This means a food plant must have a sanitation program to © 2003 by Marcel Dekker, Inc.

keep all areas of the plant clean and the cleaning is done in a manner that does not contaminate food. B. Personal Appearance and Hygiene Refer to section 110.10, Personnel, of the GMPs for detailed information about this. It states the obvious, i.e., any persons who work in and around a food plant must conduct and present themselves in such a manner that food is not contaminated. This includes personal ‘‘sanitation’’ or cleanliness as well as the clothing or uniforms worn by workers in the plant. This section details hand washing/sanitizing, removal of insecure jewelry, maintaining gloves, wearing hair/beard restraints, not storing personal items in manufacturing areas, only eating, drinking, and smoking where designated, and if you’re sick, don’t work around food! C. Facility Aesthetics We’re all only human. Think about how much nicer it is to show up for work in an area that looks nice and is clean. Design the work site sanitation program to accomplish this goal. D. Integrated Pest Management Yes, pests are attracted to soils. When this term is used in a sanitation context, it refers to undesirable residues of organic matter that result from the manufacturing of food. Pests do not come about through abiogenesis. With no accumulated soils in and around a food plant, you’ve eliminated a basic component for pest breeding—food. Pests need food, water, warmth, and a harborage to thrive. Eliminate one or, better yet, all of these, and you’ll be on your way to a pest-free food plant. Design sanitation programs to achieve this goal. Pests are no different than people when you consider only those simple requirements needed to survive and thrive. E.

Sanitary Design

More will be said about this later, but this much can be said now: if buildings and equipment are designed to be easily accessible for cleaning, sanitation programs can be designed to take advantage of this. People will more readily respond to the request to clean a piece of equipment that is of proper sanitary design. Conversely, if the equipment is poorly designed, food plant personnel are quick to respond with the phrase, ‘‘we cannot get to it or do not have time to take it apart to clean it properly, so if you think you can do it better, go ahead.’’ A good rule of thumb I like to use is when you install or make something, ask yourself, ‘‘if I had to clean that, could I or would I?’’ The answer no is not the response we want. F.

Pride in Product

This is an easy one. Just ask yourself ‘‘would I serve this food to my family knowing how it is made?’’ You’ve got to answer yes 100% of the time, with no reservations! © 2003 by Marcel Dekker, Inc.

IV. MEANINGFUL SANITATION Food plant sanitation programs must also be proactive, not reactive. You can make (save) money through sanitation by preventing costly product recalls due to adulteration. I’ve been told that a food company can expect to spend, at a minimum, $1 million to initiate a product recall. Just think of the countless millions that will also be lost due to lost sales, lost consumer conﬁdence, and brand name damage. Think of how much ‘‘sanitation’’ investment can be made with even the $1 million if you prevent product recalls! Lax sanitation makes it very difﬁcult to cover your sanitation shortcomings. The very intelligent consumer, lightning-fast media, and an unforgiving marketplace will quickly ﬁnd ‘‘mistakes’’ Unfortunately, many professional sanitarians have reduced food plant sanitation to the most basic of levels—keep the company out of the headlines and the boss out of jail. Let’s take a closer look at the proactive versus reactive food plant sanitation program. A.

Proactive Approach

Proactive ⫽ prevent, prevent, prevent. Sanitation professionals must know their food plant better than anyone else. Do not rely on third-party inspections, audits, assessments, or the federal government to ﬁnd poor sanitation practices. Sanitation programs are designed to predict and prevent undesirable situations from occurring in the ﬁrst place. More importantly, the goal is to maintain the plant in such a manner that it is unlikely that poor sanitation practices will become established. This is a 24-hour/7-day-a-week job! Food plants will get dirty and must be cleaned. One must design sanitation programs and cleaning frequencies based on the type(s) of products produced. Risks must be identiﬁed and managed. Soil accumulations can break off and adulterate food as well as attract/harbor pests (e.g., microbes, insects). Dry operations can normally have a longer ‘‘break’’ from a complete sanitation cycle because dry conditions are not as conducive to microbial growth as are wet operations. B.

Reactive Response

Reactive means it’s already too late. You receive the 2 a.m. phone call that ‘‘bugs’’ have been found and what are you going to do about it. All of a sudden, the plant sanitation department has a staff of one! 1. Risk Management Sure, you can manage the risk by waiting until a problem is discovered, but you won’t win in the marketplace with this strategy. The damage is done, product may be adulterated, recall(s) may be needed, production time lost, headlines gained, a company’s brand damaged, and people can lose their jobs! ‘‘Protect the brand’’ should be the rallying call for proactive sanitation. With this philosophy, everyone becomes a sanitation expert when the problem is discovered, lots of blame and ‘‘woulda/coulda/shoulda’’ to go around. It’s costly to regress and now worry about implementing permanent food plant sanitation control. C.

Reactive Versus Proactive Management

Unfortunately, the reactive sanitation still occurs in the industry. Management must treat sanitation professionals as professionals, and this positive attitude must carry right on © 2003 by Marcel Dekker, Inc.

through the hiring and compensation process. Food plant sanitation workers cannot be looked at, and workers must not be treated, as the most disrespected members of the plant workforce. Disrespect is likely to promote substandard performance on the job. People react to the way they’re treated, positively or otherwise. Plant management cannot ignore the sanitarian’s knowledge or requests for assistance when needed. For the success of a proactive program, food plant management and sanitation professionals must have knowledge of basic food safety pests that poor sanitation can magnify. These could be macrobiological (i.e., insects, birds, rodents) or microbiological. Over the past few years, allergen contaminants have become focal points of many plant sanitation programs. To control all these pests, management teams and all plant personnel must plan, organize, cooperate, supervise, and be held accountable for all assigned tasks. V.

SANITATION: MACRO VERSUS MICRO

These terms are ﬁnding their way into the lexicon of plant sanitarian. What do they mean? How important are they? A. Macrosanitation Macrosanitation can be deﬁned as practicing sanitation by cleaning areas/equipment easily seen with the naked eye and at a height that requires minimal bending/reaching by the individual. It’s easy to see soils that can be removed by minimal effort on the cleaners’ part. Once initiated and ﬁrmly in place in a food plant, it is a plant sanitation program that will lead a facility down the road to a food safety incident. We do a very good job of cleaning soils from areas that fall wtihin the deﬁnition of macrosanitation. Unfortunately, these are not the soils that will get a food plant into trouble. It is the soils that are missed due to the lack of a ﬁrmly embedded and practiced sanitation program of microsanitation! B. Microsanitation Microsanitation can be deﬁned as practicing sanitation by cleaning areas/equipment not easily seen with the naked eye and require additional lighting (i.e., ﬂashlights) or other aids, such as ladders to allow cleaners to get to higher soiled locations. Microsanitation also requires cleaners to get down low, sometimes on hands, knees, or bellies to clean up under and around equipment areas that are not seen from straight-ahead viewing. This is the type of sanitation program that must be practiced with rigor and frequency to remove ‘‘invisible’’ (that is, not readily noticed) soils that if missed during sanitation cycles will become harborages for microbes or insect pests. 1. Attention to Details Microsanitation is not easy or glamorous work. But it must be done. Cleaning personnel must also be properly trained on where and why to be alert for microsanitation harborages and be provided with the proper cleaning tools/chemicals to do the proper job. They must be instructed to look high, look low, and get down on their hands and knees to thoroughly inspect all nooks and crannies, for soil deposits. Microsanitation involves physical scraping or scrubbing to remove soils, not just using high-pressure water or air alone. Being good at microsanitation must be the goal and inspiration of all plant sanitarians and sanitation personnel. © 2003 by Marcel Dekker, Inc.

2. Proactive Sanitation Proactive sanitation in a food plant is predominantly controlled by good housekeeping, nothing scientiﬁc here. Food plants must be efﬁcient operations to be successful. This means all personnel working in a plant must ‘‘clean as you go’’ and keep their respective work areas in good shape during their shifts. Plant managers no longer have the luxury of being able to hire extra staff to pick up after others. When that sanitation crew hits the ﬂoor to clean, time is not unlimited. They must get right to their cleaning assignments and cannot waste time, nor be expected to pick up trash, sweep work areas, remove production items such as packaging or raw materials that may become cross-contaminated during sanitation procedures. The previous shift must have their work areas ‘‘secured’’ for sanitation by shift’s end. Time taken by the sanitation crew to do this housekeeping cleaning severely restricts their time left to do the actual cleaning of areas/equipment that prevents pests. This thought process must cross over all departments in a plant, especially maintenance, production, quality, and janitorial personnel. If pests usually associated with defective sanitation have no food, water, harborage, or suitable temperature, they cannot become established. Good housekeeping and general sanitation practices are the key problem preventers and contributors to a clean, efﬁcient, and proﬁtable food plant. VI. ELEMENTS OF SUCCESS The success of an organized food plant sanitation program depends on many things. A.

Management Participation

If the plant manager is not fully committed to running a clean plant, the others working in the plant ﬁgure this out quickly. ‘‘He or she is all talk’’ is what you’ll hear from the workforce. The plant manager must back up words and actions and support to be successful. Managers must be familiar with the basics of sanitation and get out into the plant onto the ﬂoor and work with their people to communicate expectations, goals, visions, or desires. Don’t stay in the ofﬁce! I’ve inspected plants where, from the observed results, the plant manager has no real clue as to what’s actually going on on the ﬂoor. He or she has relied on the information subordinates have passed on up the chain of command. Of course, no one likes to pass on bad news, so they don’t! Adequate sanitation equipment, budgets, personnel, tools, and materials need to be provided with the plant manager’s blessing and encouragement. Take the lead in the sanitation practices of your plant, Mr. or Ms. Plant Manager. Be a leader by example. B.

Plant Sanitarian

This individual is recommended no matter how large an operation is. A full-time, duly compensated position, that reports to the plant manager is the best scenario, as this eliminates any conﬂict of interest one may have when the sanitarian reports to the production or quality departments. This position is different from a janitor or sanitation supervisor. Technical training is vital to the success of a sanitarian. A successful plant sanitarian should also not be expected to do many other jobs day © 2003 by Marcel Dekker, Inc.

to day. This should be a supervisory position with adequate time allotted to properly perform the duties of a sanitarian (i.e., inspecting, auditing, planning, and supervising). Being able to communicate and work well with others is an asset to a successful sanitarian. Professional sanitarians must be given the resources and time for continuing technical training so the train-the-trainer philosophy can be used to transfer this knowledge to the plant’s workforce. Because there are so many rules and regulations that impact food manufacturing, the plant sanitarian is expected to maintain pace in the acquisition of knowledge concerning pests, microbes, laws/regulations food safety systems and the science of cleaning. This does not necessarily mean a plant sanitarian must be college degreed. However, such college-level training will certainty be an asset in this job. Conversely, I’ve had the positive experience of knowing many excellent plant sanitarians that have learned through years of continuing education and experience on the job—stuff not taught in school. It’s a great catch when a plant sanitarian is hired with the technical skills to do the job plus the ability to hit the ground running in a food plant by quickly assimilating the day-to-day operations and understanding the role of plant sanitation. This sanitarian is a keeper. C. Self-Inspection Program The GMP/sanitation self-inspection program is the rock-hard foundation of a successful, proactive food plant sanitation program. A formal food safety committee needs to be formed. Its members are multidisciplinary (i.e., production, quality, management, and maintenance), comprising salaried and nonsalaried workers alike. Members should be rotated on and off the committee as this greatly beneﬁts in the cross-training of all plant personnel as to what is expected, accepted, right, and wrong with GMPs/sanitation. 1. Sanitary Design Sanitary design, or lack thereof, of equipment and buildings must not be overlooked during these inspections. If equipment is improperly designed and cannot be easily cleaned or disassembled to clean, it will remain dirty because most people do not have the luxury of extra time to do all that’s necessary to clean it properly. An excellent reference book on sanitary design is Engineering for Food Safety and Sanitation [1]. Every food plant sanitarian and plant engineer should wear this book out from a reference and guidance standpoint. 2. Detailed Inspections The goal of this committee is to do detailed inspections of the entire plant on at least a monthly basis. Why monthly? Because under the best conditions, stored product insects can go through a life cycle (egg, larva, pupa, and adult) in 4 of 5 weeks. The thinking is that if you identify and eliminate potential poor GMP/sanitation conditions, you will stay ahead of any infestation problems. Deﬁciencies observed during these inspections must be documented for proper follow-up and corrective actions. This is a key point! Deﬁciency completion must be noted as many of us are very good at creating to-do lists but do a poor job of following through to completion/closure of such tasks. Most food plants do not need more lists. Deﬁciencies not completed at the time of the next self-inspection should be prioritized for completion ASAP. If capital is needed, this should be noted and the appropriate requisitions initiated. © 2003 by Marcel Dekker, Inc.

3. Subdivision of Tasks If the food plant is large, I recommend dividing it into four areas and inspect one area per week. Such inspections must be focused and detailed. It is better to do one good inspection versus many cursory ones. Plant interior and exterior areas are both included. Be sure to inspect areas no people dare to go during normal day-to-day operations or walking routes. Look high, look low! Have you been on the roof or in your basement storage areas lately? People that work in a food plant must know their plant, inside and out, better than anyone else. If I’m coming in to do a ﬁrst-time inspection of your plant, I should not be able to ﬁnd ‘‘new’’ areas that have been overlooked during the monthly inspections. That’s what your own in-house self-inspections should be doing! Don’t allow a stranger (e.g., regulatory inspector or other third party) to come into your plant and ﬁnd areas or niches that you did not even know existed. Know thy plant! Inspect every nook and cranny at least once, assuring for yourself that this area should be no problem. 4. Independent Sanitation Audits An excellent idea is to have, at least annually, an independent third party do a GMP inspection of the plant. This can be used as a benchmark and learning experience for the existing plant food safety committee. Many large food companies have corporate sanitarians to do this; many commercial companies are available, too. Not meant to be an inclusive list or an endorsement of one over the other, examples of such commercial companies that I’ve had experience with are American Institute of Baking (AIB) (800-633-5137); American Sanitation Institute (ASI) (800-477-0778); Silliker Laboratories (708-957-7878); Cook & Thurber (608-831-6958); and Randolph and Associates (205-979-6455). One can debate on the need to score such an inspection. Human nature being what it is, we like numbers, scores, and data. Scoring can be done as a reference point but we must not get caught up in a numbers game. I know of no perfect scoring system. Focus on the deﬁciencies noted, root-cause analysis, and future prevention of recurrences. Any inspection, no matter who does it, is just a point-in-time reference. A food plant is a dynamic environment that constantly moves and changes. Solid, rigorous food safety systems and sanitation programs are the only way to predict and prevent problems. D.

Master Schedules

Master sanitation or cleaning schedules (MSS/MCS) (Figures 1 and 2) are the backbone of the planned supervision of a food plant sanitation program. The MSS are the preventive building blocks to operating a clean and efﬁcient plant. When properly designed and implemented, one should be able to answer the question ‘‘when was the last time this piece of equipment, structure, or area was cleaned?’’ 1. Simple and Current Master sanitation schedules need not be fancy or computerized. They must be kept simple and current. Place the cleaning task and frequency down one side of the paper with the dates across the top. The goal is to list other-than-daily cleaning tasks, cleaning frequency, and date/employee initials showing when the task was successfully completed. Cleaning frequencies are determined by how quickly ‘‘soiling’’ occurs. Sanitarians must not be afraid to change these frequencies based on plant operations, equipment lay© 2003 by Marcel Dekker, Inc.

Figure 1 Sample master sanitation schedule for daily cleaning tasks.

© 2003 by Marcel Dekker, Inc.

Figure 2 Sample master sanitation schedule for scheduling cleaning tasks not to be done daily.

out, or needs. In fact, this is a must! Constantly evaluate the effectiveness of a MSS and react accordingly. 2. Timing Inspections If your plant is one that is prone to infestation by stored-product insects, remember to time your cleaning frequencies to their life cycle (e.g., monthly). You’re focusing on otherthan-daily cleaning tasks. Frequencies could be weekly, biweekly, monthly, quarterly, semiannually, and annually. Inspect each plant area individually and place those off-thebeaten-path sites or items on the MSS. For example, give attention to exterior building perimeter and fence lines, trash disposal docks, exterior screens, exterior fan louvers, rail pit areas, storage closets, overheads, dust collectors, catch pans, dock levelers, pallet rack and equipment leg bases, elevator pits, ﬂoor drains, light shield interiors, air curtains, boiler rooms, and shop/maintenance areas. All should receive MSS considerations and periodic cleaning. Cleaning frequencies are based on the nature and speed of the soil buildup and the nature of the product (dry versus wet and concerns about insect or microbial growth). 3. Cover All the Bases Don’t forget the building exterior for MSS considerations! For example, docks, garbage/ waste/trash pick-up areas, roof, rain gutters, parking lots, and bulding/property perimeters © 2003 by Marcel Dekker, Inc.

all should be placed on a MSS for periodic cleaning. Do not leave MSS slots vacant! No documented data is interpreted as the task was not done. If the line was ‘‘down,’’ note that on the MSS. Keeping a MSS current is your only ally when you must answer the question ‘‘when was this last cleaned?’’ In summary, an MSS is not your normal daily, or production, cleaning but otherthan-daily cleaning tasks. To be effective and workable, the MSS must be realistic, taking into consideration available personnel, production schedules, and special types of equipment being used. The MSS should serve as a reminder of upcoming sanitation tasks to be done as well as serving as a running checklist of tasks completed. The MSS should be kept simple. Each plant is unique, with its own challenges. Clean is clean, though, and this principle must remain constant for all plants. As an adjunct to a MSS, each food plant should develop documented cleaning procedures. These should be designed as a simple document that is given to employees to help them better understand how to effectively clean an area or piece of equipment. Cleaning procedures can include needed tools and equipment, personal safety equipment requirements, time allowed for cleaning, chemical needs and dilution rates, and equipment safety concerns such as lock out/tag out. The lock out/tag out program is a requirement of the Occupational Safety and Health Administration. Basically, it says that every plant must have a documented program/employee training in this area as a means of preventing equipment from engaging while its being worked on. It’s an accident prevention program and aimed at not allowing equipment to be turned on while someone is working on it. Each applicable employee is given his or her own personal, identiﬁable, lock out/tag out lock and tag and must place this at the power disconnect point before starting work on the equipment. No one else is allowed to remove this lock/tag, only the person that put it on in the ﬁrst place. E.

Training

The best laid plans and organization of a food plant sanitation program are doomed to failure unless the mantra ‘‘train, train, train’’ is recited and used. Sanitation comes from the heart, and all plant personnel must truly want to work in a clean plant. The training not only involves the what and how, but must also include the why. People want to do a good job but do not like to be told to do something for the sake of doing it. Sanitation professionals must communicate the why-this-is-important sanitation message to employees. Don’t tell an employee how to clean; show them, too. When we do, we remember! Many plants have monthly employee meetings to review and train people in such areas as GMPs, sanitation, and personal safety. Many times, a plant can utilize its outside sanitation chemical vendors to assist in technical subject material training. In any event, no matter how training is done it must be documented for reference and done in such a manner that all employees understand. Your imagination is the limit on training techniques. F.

Plant Environments

1. Cleaning Dry Areas There are some subtle differences in the cleaning of a wet plant or dry plant. For example, if the plant produces dry or dust-prone products, compressed air is the worst sanitation enemy. Trying to ‘‘blow down’’ a dusty area only relocates most soils and insects if © 2003 by Marcel Dekker, Inc.

present. Vacuuming is the preferred method of cleaning dry, dust-prone areas. Such cleaning equipment must also be properly used and serviced, otherwise the vacuums themselves may become pest harborages. Place them on your MSS. Remember: treat the root cause, not the symptom. If dust is a problem, equipment leaks are usually the culprit. Fix the leaks. Over the long-term, it’s cheaper than spending time and resources to chase dust. Keep water out of dry, cleaned areas; many dry products will mold if adequate moisture is present. Flour may contain the microbial pathogens Salmonella and Listeria. Moisture is what they need to ﬂourish. Water and ﬂour mixtures not thoroughly removed can also dry to form a crust-hard layer that can easily hide insects underneath. I’ve seen situations where this layer around equipment leg bases has actually been painted white because it was assumed it belonged there! An inspector comes along to ﬁnd this, loosens the crust, and insects are found! 2. Cleaning Wet Areas When designing a sanitation program to clean wet areas, be wary of automatic cleaning equipment such as CIP (clean in place) or COP (clean out of place). The word automatic can lull us into a false sense of security. Use your home washing machine as an example. Clothes will not become clean on their own by just turning on the machine. You need to be sure you have the proper wash time, water temperature, velocity or agitation, and proper amount of soap. We can simplify these to time, temperature, velocity and chemical concentration. This is not so different in a food plant situation, but here we’re cleaning equipment not clothes. These CIP and COP systems are designed to be effective and efﬁcient only if these four parameters are consistently met. We cannot forget soil type, either. Different soils require different combinations of the four parameters for effective cleaning. For example, carbohydrates, proteins, and fats cannot be cleaned the same way. Each is unique in its requirements. Know your soil type. Sanitarians do not have to memorize all of this information or be college degreed to succeed. Experience is a valuable teacher. Work with your plant sanitation chemical vendor on these parameters. Lean on them. Let them be your guide. Clean is clean. You’ll know in a hurry if it works or not. Don’t just rely on turning on the CIP or COP equipment switch, then walk away and assume all is well. What happens when you assume? Pumps break, gaskets leak, piping changes! Programs should be implemented to document and verify time, temperature, velocity, and concentration, too. These can be simple chart recorders, thermometers, pH paper strips, titrations, or pumping a known volume of ﬂuid through a known pipe length in a speciﬁc amount of time to determine velocity. For CIP systems, a velocity of at least 5 ft/sec through pipes is the benchmark standard. 3. Sanitation 4 ⫻ 4 Going back to the washing machine example, heavily soiled clothes need to be prerinsed before washing for effective cleaning. Food plant equipment or utensils are no different. There are four recommended steps here, too. They are prerinse, wash, rinse, and sanitize. Putting them together, you have the sanitation four (time, temperature, velocity, concentration) ⫻ four (prerinse, wash, rinse, and sanitize). This combination will give you consistently clean CIP or COP equipment. Many food plants consider this sanitation 4 ⫻ 4 to be an essential prerequisite to the implementation of a hazard analysis and critical control points (HACCP) program. This means that after each major sanitation cycle, these sanitation CCPs must be docu© 2003 by Marcel Dekker, Inc.

mented and acceptable before the line is turned over to production. This review is part of the documented postsanitation, pre-operational (pre-op) inspection that should be done on all lines. To avoid any conﬂict of interest, the persons that do the actual cleaning should be different from the people doing the pre-op inspections. You’re looking for ‘‘visible soil’’ and GMP violations during these inspections. Adenosine triphosphate (ATP) or bioluminescent technology is available for use as a quick method to test for the presence of organic residues on allegedly clean food-contact surfaces. Note that ATP cannot be used in dusty environments; dust accumulations give false positive results. VII. SUMMARY In summary, food plant sanitation programs are not easy or cheap, nor do they happen on their own. You harvest what you sow. If corners are cut, problems will follow. A successful sanitation program needs commitment from the top down—plant manager to personnel working on the ﬂoor. It’s a way of life in a food plant. Plant sanitation personnel must be recognized as a vital link in the successful operation of a plant and treated as such. Sanitation programs must be well thought out and documented. Ongoing training must occur. Audits and inspections play a key role in assuring the successful operation of a sanitation program. ‘‘So you want the line down to clean?’’ ‘‘How much time do you need and when do you need it?’’ That’s the response we’re looking for! REFERENCE 1. T Imholte-Tauscher. Engineering for Food Safety and Sanitation. A Guide to the Sanitary Design of Food Plants and Food Plant Equipment, 2nd Ed. Woodinville, WA: Technical Institute of Food Safety, 1999.

© 2003 by Marcel Dekker, Inc.

23 Sanitation and Warehousing Y. H. HUI Science Technology System, West Sacramento, California, U.S.A. WAI-KIT NIP University of Hawaii at Manoa, Honolulu, Hawaii, U.S.A. J. RICHARD GORHAM Consultant, Xenia, Ohio, U.S.A.

I.

INTRODUCTION

This document concentrates on the receipt, storage, and distribution of foods and food products in relation to current good manufacturing practice regulations (CGMPRs). Note that the narrative is presented in the teacher–student format and that the active voice is used. The data have been compiled from three major sources: 1. Food and Drug Administration (FDA) documents: Code of Federal Regulations, Current Good Manufacturing Practices (CGMPs), the Food Code, Hazard Analysis and Critical Control Point (HACCP) programs 2. U.S. Department of Agriculture (USDA) documents: Code of Federal Regulations, HACCP programs, inspection manuals, directives, etc. 3. Recommendations developed and distributed by major trade associations representing food, warehousing, and transport and related industries

© 2003 by Marcel Dekker, Inc.

II. BASIC REQUIREMENTS FOR SANITATION IN A FOOD PROCESSING PLANT Various aspects of the following basic sanitation topics are covered in other chapters of this book: 1. 2. 3.

4.

Grounds and buildings Fixtures and equipment Sanitary facilities a. Water supply, sewage, and plumbing b. Toilet and handwashing facilities c. Dressing and locker areas d. Eating areas Sanitary operations a. Keep buildings and equipment sanitary b. Rubbish and pest management

III. PROCEDURES AND CONTROLS As the responsible sanitation ofﬁcer in your company, you will consider the following: Implement overall sanitation under the supervision of an individual assigned responsibility for this function. Conduct operations in the receiving, inspecting, transporting, handling, segregating, recouping, and storing of foods in accordance with appropriate sanitation principles. Take reasonable precautions, including assuring that food warehouse procedures do not contribute to contamination of foods by harmful chemicals, objectionable odors, or other objectionable materials. A.

Incoming Product Shipments

The integrity of the food warehouse sanitation program requires that the materials received, including foods and their packaging materials, must not be exposed to contamination by reason of infestation by insects, birds, rodents, or other vermin, or by introduction of ﬁlth or other contaminants. It is often useful, when practical, to work with suppliers and shippers in advance to establish guidelines for acceptance, rejection, and, where appropriate, reconditioning of particular products, taking into consideration factors such as the nature, method of shipment, and ownership of the product, in order to facilitate the effective implementation of these programs. Within a reasonable time after arrival of a railcar or truck, and before product is unloaded, the product should be inspected to the extent permitted by the loading of the vehicle for evidence of damage or of insect or rodent infestation, objectionable odor, or other form of contamination. Where an adequate inspection has not been possible prior to unloading, further inspect such product during and immediately after unloading. If damaged product has been accepted, keep it separate from other product, and recondition or otherwise handle it as necessary in a manner which will not expose foods or the food warehouse to contamination or infestation. If the inspection reveals evidence of infestation or contamination, determine whether the condition is only ‘‘suspect’’ or is superﬁcial (such as surface infestation of ﬂying © 2003 by Marcel Dekker, Inc.

insects which may be on, but have not penetrated, soiled, or compromised the integrity of the packaging) and might be fully correctable by fumigation or other means. In each such case, remove the product from the food warehouse area, utilizing the vehicle in which it arrived, if feasible, after closing and sealing it. In case of contamination, if rejection is appropriate (based on the origin and ownership of the product), promptly notify the carrier and shipper of the time, place, and circumstances of the rejection. After removal from the food warehouse because of suspect and/or superﬁcial conditions, concentrated efforts can be made to further evaluate the actual condition of the product and to recondition it when possible. Give special attention to product which has been previously rejected, or has otherwise been removed from the food warehouse because of suspect and/or superﬁcial conditions, when it is subsequently received again to assure that the product and packaging are fully acceptable on reinspection. In the event of serious question or of failure to agree with the shipper or carrier, as appropriate, as to condition or reconditioning, consider requesting evaluation of the suspect or rejected product by appropriate federal, state, or local authorities. B. Product Storage and Stock Rotation Place foods received into the food warehouse for handling or storage in a manner that will facilitate cleaning and the implementation of insect, rodent, and other sanitary controls and will maintain product wholesomeness. Adopt and implement effective procedures to provide stock rotation appropriate to the particular food. C. Contaminated or Damaged Foods Unless promptly and adequately repaired or corrected at or near the point of detection, promptly separate foods which are identiﬁed as being damaged or are otherwise suspect from other foods for further inspection, sorting, and disposition. Promptly destroy or remove from the food warehouse product determined to present a hazard of contamination to foods in the food warehouse. D. Hazardous Nonfood Products and Packaging Protection Handle and store nonfood products that present hazards of contamination to foods stored in the same food warehouse by reason of undesirable odors, toxicity of contents, or otherwise in a manner which will keep them from contaminating the foods. Take special measures to safeguard from damage and infestation those foods that are particularly susceptible to such risks. Exercise care in moving, handling, and storing product to avoid damage to packaging that would affect the contents of food packaging, would cause spillage, or would otherwise contribute to the creation of insanitary conditions. E.

Shipping Precautions and Temperature Controls

Prior to loading with foods, inspect railcar, truck, and trailer interiors for general cleanliness and for freedom from moisture; from foreign materials which would cause product contamination (such as broken glass, oil, toxic chemicals, etc.) or damage to packaging and contents (such as nails, boards, harmful protrusions, etc.); and from wall, ﬂoor, or © 2003 by Marcel Dekker, Inc.

ceiling defects that could contribute to insanitary conditions. Clean, repair, or reject them as necessary to protect foods before loading. Exercise care in loading foods to avoid spillage or damage to packaging and contents. Maintain docks, rail sidings, truck bays, and driveways free from accumulations of debris and spillage. Maintain warehouse temperatures (particularly for refrigerated and frozen food storage areas) that are in compliance with applicable regulatory temperature requirements, if any, for maintaining the wholesomeness of the particular foods received and held in such areas. F.

Housekeeping, Sanitation, and Inspection

Establish a regularly scheduled program of general housekeeping, sanitation, and inspection to maintain ﬂoors, walls, ﬁxtures, equipment, and other physical facilities in a state of sanitation sufﬁcient to protect foods from contamination or adulteration and to prevent waste from becoming an attractant and harborage or breeding place for vermin. In addition, develop and implement an effective program and procedure for timely cleanup of any debris and spillage resulting from accidents or other unscheduled occurrences. G.

Pest Control Measures

Implement pest control measures designed to prevent the entrance of pests, to deny them harborage, and to detect and eliminate them with such schedules, instructions, and procedures and by such trained and qualiﬁed personnel or professional representatives as may be necessary, based on the nature of the foods and other products handled, the structure and condition of the building and equipment, and the surroundings of the warehouse. Monitor traps and bait stations, whether inside or outside of buildings, on a regular basis. Use covered interior bait stations designed, located, or protected to prevent spillage. Where appropriate, use bait stations constructed of moisture-proof materials. Use only pesticides with labels showing EPA registration numbers, and only for the uses speciﬁed in the labeling. Have them applied only by responsible personnel in accordance with the manufacturer’s labeling instructions and in a manner that prevents contamination of foods. While not in use, clearly mark and store pesticides in a secure place apart from foods. H.

Food Sanitation Audit Programs

Establish programs internally and/or through outside consultants for effective auditing of the food warehouse sanitation program. IV. PERSONNEL A.

Employee Practices

Prohibit employees affected by disease in a communicable form, while carriers of such disease, or while afﬂicted with boils, sores, infected wounds, or other abnormal sources of bacterial infection, from working in the food warehouse in capacities in which there © 2003 by Marcel Dekker, Inc.

is a likelihood of food becoming contaminated or of disease being transmitted to other persons. Prohibit clothing or other personal belongings from being stored and food and beverages from being consumed and tobacco from being used in areas where foods are handled or stored. Instruct employees who are working in direct contact with exposed or partially exposed foods, such as produce items in mesh bags, etc., to maintain personal cleanliness and to conform to hygienic practices to avoid contamination of such foods with microorganisms or foreign substances such as human hair, perspiration, cosmetics, tobacco, chemicals, and medicaments and, if gloves are used in handling such foods, to use only gloves which are of an impermeable material in handling such foods and to maintain them in a clean and sanitary condition. B. Management Responsibilities Assign responsibility for the overall food warehouse sanitation program and authority commensurate with this responsibility to persons who, by education, training, and/or experience, are able to identify sanitation risks and failures and food contamination hazards. Instruct employees in the sanitation and hygienic practices appropriate to their duties and the locations of their work assignments within the food warehouse. Instruct employees to report observations of infestations (such as evidence of rodents, insects, or harborages) or construction defects permitting entry or harborage of pests or other developments of insanitary conditions. Exercise programs of follow-up and control to ensure that your employees, consultants, and outside services are doing their jobs effectively. V.

IMPLEMENTATION PLAN

This plan has been prepared to assist the food warehouse operator in implementation of the recommendations just discussed. Information in this plan will require adaptation for speciﬁc application to your operations. Since no single document can provide all the necessary information for every situation or specify the only methods for compliance, develop your own plan or company guidelines to reﬂect your individual applications in the general areas dealt with in the recommendations and this plan. A. General Considerations To ensure product wholesomeness and proper sanitation, the food warehouse sanitation program must have the commitment of top management, must be implemented by the supervisor of operations, and must be supported by the entire food warehouse staff. Preventive sanitation—the performance of inspection, sanitation, building maintenance, and pest control functions designed to prevent insanitation in preference to correcting it— should be an important goal of food warehouse management and of food warehouse operations. B. Organization and Programs A program to ensure continued success in safeguarding the wholesomeness of food and in providing good sanitation will ordinarily include © 2003 by Marcel Dekker, Inc.

1. 2. 3. 4. 5. 6.

An organizational chart showing chain of authority and responsibility A ﬂow diagram of receiving, storage, and shipping operations Regular maintenance schedules Regular sanitation programs Regular pest control programs An effective program of follow-up and control, including reports to responsible executive ofﬁcer(s)

VI. CHECK POINTS AND ADDITIONAL GUIDES In any sanitation program, checklists have the same usefulness as the preﬂight checklists a pilot uses before ﬂying. The data presented so far can be transformed into checklists for implementation and evaluation by assigned individuals or groups in a food processing facility. They are provided herein. A.

Grounds Keep nearby grounds free of liquid or solid emissions that could be sources of contamination. Prevent grounds from providing conditions for insect or rodent harborage. Check paving, drainage, weed and litter control regularly. Stack materials that are stored in the open neatly and away from buildings and on racks above ground level when feasible. ‘‘No vegetation strips’’ around exterior building walls and at property lines adjacent to properties containing potential harborages are helpful for discovering and discouraging travel by rodents.

B.

Buildings Provide separate and sufﬁcient space for placement of equipment and storage of materials necessary for proper operations. Separate activities that might cause contamination of stored foods with chemicals, ﬁlth, or other harmful material. Check structural conditions, pest barriers, and repair of windows, screens, and doors continuously. Seal and clean ﬂoor–wall junctions and ﬁll holes and cracks; a painted inspection strip is also recommended. Keep ofﬁces—including overhead ofﬁces—in the food warehouse clean and do not permit them to become attractants or harborages for insects or vermin. Include them in the pest control program. Check false ceilings for harborage of insects and rodents. Give basements, attics, elevators, and rail sidings, etc., special attention.

C.

Sanitary Operations Keep walls, ceilings, and rafters free of soil, insect webbing, mold, and similar materials. Do not leave unscreened doors and windows open unnecessarily. Do not permit dust to accumulate.

© 2003 by Marcel Dekker, Inc.

Keep ﬂoors free of product spillage, oil drippage, and buildup in all areas. Provide proper trash and refuse storage and removal. Store tools and equipment properly. Clean and ﬂush ﬂoor drains regularly. Maintain railroad and truck courts free of debris and properly patrol them for pest control. Keep eating and break areas, locker rooms, etc., clean and orderly. Vending machines are often overlooked; keep them and the areas adjacent to them clean and sanitary. Maintain equipment in a properly functioning condition and do not permit it to serve as a source of sanitation or harborage problems. D. Receiving and Inspection Inspect the materials which are being received for evidence of damage; insect, bird, rodent, or other vermin infestation; and moisture, odor, or chemical contamination. Exclude contaminated materials, including product, pallets, and slipsheets, from the building. If damaged merchandise is accepted, segregate it for special handling. Make sure that incoming and outgoing vehicles are free of conditions that could contaminate product—no birds, rodents, insects, spillage, or objectionable odor should be evident. Code or mark foods received at the receiving point to ensure proper stock rotation. To facilitate handling of rejected and suspect product, it is often a good idea to develop procedures with individual shippers, carriers, and/or manufacturers for reinspections, returns, etc. E.

Storage Store products in an orderly manner and stack in such a way that date codes are visible for proper rotation. Generally, it is desirable to stack foods on pallets or racks (or on slipsheets, where a clamp truck operation is utilized) away from walls so as to allow for inspection aisles between stacks and walls. Painting inspection aisles in a light color is often helpful in maintaining their effectiveness. Where full inspection aisles are not provided, take special care (such as more frequent inspection, rotation, and removal of product for cleaning) to ensure sanitary, pest-free conditions. Separate bagged and baled foods to provide visibility between stacks. Dispose of contaminated or infested merchandise, or otherwise remove it from the food warehouse promptly. Promptly remove damaged merchandise and broken containers from general food storage areas. Handle and process salvageable merchandise separately in an area isolated from general food storage; this area probably will require extra sanitation and pest control attention. If salvage operations include the repackaging or other manipulation of exposed foods (other than items such as fresh produce received unpackaged or in partially open packages), conduct such operations in compliance with the food sanitation practices, guidelines, or regulations (such as 21 CFR 110, GMPs, and other FDA documents) that are applicable to handling exposed foods.

© 2003 by Marcel Dekker, Inc.

Do not intermingle chemicals, including pesticides, with food or food products. Such products must be kept in locked storage, separate from food-handling areas. F.

Pest Control Maintain written schedules, log activity, and monitor traps and bait stations regularly. Use covered bait stations that are of such types and so located as to reduce the danger of spillage, and where appropriate use moisture-proof bait stations. Keep the pesticides that are used in the food warehouse secured and separate from foods. Permit their use only by properly trained personnel. Use only types registered and approved by an appropriate government agency for the intended use. Check especially for (1) rodent burrows in nearby grounds, (2) activity at ﬂoor– wall junctions and doorways, and (3) insect crawl marks in duct accumulation, especially on overhead pipes, beams, and windowsills, around ﬂour, sugar, and pet food storage. Where feasible, seal load levelers at docks to prevent trash accumulations and rodent harborage and entry; otherwise clean them frequently. Look for insect activity in folds of bagged foods. Use black light, supplemented with means for distinguishing other chemicals that ﬂuoresce, to check for rodent urine stains; and use ﬂashlights to check for other evidence of contamination.

G.

Shipping Make sure that transportation equipment into which food warehouse food is loaded is maintained in a sanitary condition comparable to that of the food warehouse. Make sure that rail cars, trailers and trucks are (1) free of birds, rodents, and insects or contamination from them and (2) free of accumulations of dirt or dunnage and in good repair with no holes, cracks, or crevices that could provide entrances or harborages for pests.

H.

Follow-Up

Implement programs of follow-up and control to ensure that your employees, consultants, and outside services are doing their jobs effectively. VII. CASE STUDY: INSPECTING INCOMING FOOD MATERIALS AND RAW INGREDIENTS In its effort to help quality control programs in food plants, the FDA has issued a special bulletin titled ‘‘Inspecting Incoming Food Materials’’ [USDHHS, PHS, FDA, HHS Publication No. (FDA) 76-2017]. Because of its important educational value, every food plant should make an effort to assure that its quality control personnel become familiar with its content. A slightly modiﬁed version of this bulletin is presented here. The format is that of teacher (FDA) and student (employee). A.

Introduction

If you are given the job of inspecting and unloading cartons of incoming food materials, be familiar with this section. It will help you make a good start. A sample inspection form © 2003 by Marcel Dekker, Inc.

(Fig. 1) is provided to guide you during your inspection. Discuss these materials with your supervisor and ask him/her for any additional guidelines or instructions. Remember, a good thorough inspection of incoming food materials is the ﬁrst line of defense against producing infested or otherwise contaminated ﬁnished products. By following the guidelines of this inspection report and recording your ﬁndings, you will make a good beginning and will greatly help your supervisor to make the correct decision regarding rejection or acceptance of incoming shipments. Many ﬁrms provide additional consumer protection by notifying the local FDA ofﬁce regarding shipments they have rejected. Commercial ﬁrms are free to reproduce this form to use as a supplement to their own inspection form or excerpt portions from it and devise a new form. B. Why Should You Inspect Incoming Food Materials? To make your money, your ﬁrm must handle only good products. Rotten, spoiled, or contaminated food materials will never change into good products! Very often, ﬁrms that accept contaminated and spoiled food materials are forced to go out of business. When this happens, employees lose their jobs! Contaminated and spoiled food can make people sick, including you, your family, and anyone else who may eat this food. Since most of us cannot be there to inspect the food materials as they are delivered to your ﬁrm, we depend on you to make a good inspection and to make sure contaminated food materials do not enter your plant. C. Will You Inspect? To do this right, you have to know how to inspect and what is needed to make a good inspection. D. Before the Shipment Arrives Before the shipment arrives, make sure of the following: The storage space for the shipment is clean and dry. The equipment you will use to handle incoming food materials is clean and in good repair. You have the following tools so you can make a good inspection: magnifying glass ﬂashlight black light (ultraviolet light) source (for identifying rodent urine) sample containers (plastic bags with self-seals or glass jars with covers) sample thief, trier, and spatula other equipment to aid inspection of speciﬁc products inspection report form marking pencil You do not contaminate the product during sampling. You follow speciﬁc instructions given by your supervisor. If you follow these and your supervisor’s instructions and use the equipment properly, you will make a good inspection and help assure that only clean, wholesome ingredients and food materials are used in the products you help manufacture. © 2003 by Marcel Dekker, Inc.

Figure 1 Sample inspection report for incoming food materials. © 2003 by Marcel Dekker, Inc.

Figure 1 Continued.

E.

Note Outside Condition of Carrier

The outside condition of the carrier may indicate contents were exposed to contamination while in transit. The reasons are simple; mud, dirt, water, oil stains, or heavy insect debris on the outside of a carrier may have found its way to the products. For example, if the outside is wet, seepage may have occurred and contaminated the contents. The shipment is more likely to be contaminated if the carrier is (1) an open-bed truck that is not properly covered or (2) a truck or boxcar that is visibly damaged. Notify your supervisor if you suspect shipment was exposed to contamination while in transit. Also note in your inspection report the type of carrier bringing the shipment. F.

Is the Seal Broken?

The manufacturer afﬁxed the seal to assure that you receive the high quality products manufactured and shipped; if the seal is broken, the acceptability of the products in the shipment should be suspected. The reasons are as follows: © 2003 by Marcel Dekker, Inc.

A broken seal may indicate that some of the merchandise was stolen or that poor quality products may have been substituted after your shipment was loaded and before arrival at your plant. Toxic nonfood items may have been added to the load, possibly contaminating your products, and removed before delivery of your shipment. Compartment doors may have been opened to air out foul odors shortly before arrival at your receiving dock. Odors may have accumulated from trash, ﬁlth, or spillage from previous shipment or your present shipment. Do not accept shipment if seal is broken; notify your supervisor before proceeding further with the inspection and receiving. G.

Open the Doors

Check for off-odors and high temperatures. If you ﬁnd off-odors in any shipment or the temperature is high in refrigerated loads, it may mean the delivered products are unsafe. The reasons are as follows: 1.

2. 3. 4. 5. 6.

Foul odors may have been caused by the failure to remove food particles, ﬁlth, and infestation resulting from previous shipments or failure to clean the carrier properly before loading your shipment. The products may have been decomposed before being loaded, causing the offodor. The products may have absorbed harmful off-odors before shipment. Toxic solvents, petroleum products, or chemicals may have been carried with your shipment and unloaded before arrival at your receiving dock. Frozen products, in the refrigerated load, may have been allowed to thaw during shipment, permitting bacteria to grow and produce off-odors. High temperatures in refrigerated compartments will allow the few bacteria normally present in the products to increase to dangerous numbers and to produce harmful decomposition products and odors.

Do not accept shipment if off-odor or high temperature is observed. Instead, close the compartment doors immediately and tell your supervisor. Such products can be a danger to health and therefore may be seized. H.

Note Condition of Cargo

Packages, cartons, and similar types of containers protect the products they contain. If they are broken, crushed, or otherwise damaged, their contents will be exposed to possible contamination. The reasons are as follows: It is difﬁcult to prevent contamination of food products in damaged packages, cartons, or other containers. Broken packages or containers may mean the product was contaminated and violative before it was loaded and shipped. The damage may have occurred while the product was in storage and contents exposed to insects, rodents, or other contamination while awaiting shipment. Harmful chemicals or pesticides may have entered the broken containers. The shipment may have been improperly stacked or mishandled while loading or not protected while en route to your plant. © 2003 by Marcel Dekker, Inc.

Do not invite trouble; set aside all damaged cartons, containers, and packages. Do not tape over or repair holes or other damages you may ﬁnd in packages or cartons; report to your supervisor if you discover many broken or damaged cartons. I.

Look for Insect, Rodent, or Bird Activity

Finding insects, rodent excreta, bird feathers or droppings, or rodent urine (detected with ultraviolet light) is evidence that the products were exposed to contamination, making them unﬁt for food. Do not accept shipments containing insect, rodent, or other ﬁlth. The reasons are as follows: Insects, rodents and birds are often carriers of disease-producing bacteria and parasites. Rodent excreta or droppings and urine can transfer these organisms to food products. Products may have been contaminated with this ﬁlth before being shipped to your plant. The FDA will seize products stored in your warehouse if they are exposed to or contain insect or rodent or other ﬁlth. The ﬁlth does not have to be found in exposed products to make the product subject to legal actions. Notify your supervisor as soon as possible when you ﬁnd evidence of insect, rodent, bird, or other contamination in the shipment. J. Collect Random Samples Random samples should be collected from the shipment and examined for contamination either on the spot or in the laboratory. The reasons are as follows: It is not possible nor practical to examine the contents of every packaged product in the shipment because the package is not saleable after opening and may become contaminated before being used. Random samples that are representative of those in the entire shipment can be relied upon to show if products are acceptable or contaminated. We can get a true picture of the entire lot only if the samples are collected randomly (i.e., every tenth, twelfth, thirtieth, etc., package, depending on the number in the shipment). If you are given the job to unload and inspect the shipment and no one is available for on-the-spot examination of the contents of packages, ask your supervisor for instructions as to the number of cartons of packages he/she wants you to take randomly from the load to set aside for later examination, either on the spot or in the laboratory. Follow the instructions carefully because it is important that samples be collected randomly. If you are assigned to make on-the-spot examinations of collected samples, be sure you follow proper instructions and know how to use all of the inspection tools listed in the ‘‘Inspecting Incoming Food Materials’’ booklet. Ask your supervisor for more speciﬁc instructions for on-the-spot or laboratory examinations. Proper sample collection and examination will help prevent accepting contaminated shipments that should be rejected. Do your part to help your supervisor make the proper decision. © 2003 by Marcel Dekker, Inc.

K.

Are Nonfood Items in the Shipment?

Write in your report any nonfood products (liquid or dry) that you ﬁnd in the shipment with the food items. Such products may be poisonous and can be a source of food product contamination. For example, there is no way you can be sure containers of nonfood products will not leak or break during shipment or storage and contaminate the food items, making them poisonous or otherwise unﬁt to eat, which can happen without your knowing since no change in the appearance of the food products may take place. You don’t have to ﬁnd the poisonous stuff in the material to reject the shipment. The Food, Drug, and Cosmetic Act, which protects consumers, says in simple words that a food product is illegal if it is prepared, packed, or held (or shipped) under conditions which may have caused it to become contaminated with ﬁlth or which may have caused it to become dangerous to the health of consumers (such as by exposing it to poisonous substances). Be very careful about accepting foods shipped or stored with nonfood products that may be poisonous. L.

Observe Inside Condition of Carrier after Unloading

Floors and walls in disrepair and residue wastes from nonfood shipments can cause contamination. The reasons are as follows: 1. 2. 3.

Cracks and broken boards are good hiding places for insects that could invade the shipment while in transit. Residues from nonfood items previously shipped in the carrier can contaminate food products. Presence of cracks, splinters, or broken boards may have prevented satisfactory cleaning and sanitizing of the carrier’s interior prior to loading your shipment, increasing the chance for contamination.

If the inside condition of the carrier you are inspecting is bad, mention it in your inspection report. To discourage infestation, make sure all of the paper liners and wastes from your shipment are removed and the truck or railcar is swept clean before releasing it. VIII. FDA WARNING LETTERS FOR DEFICIENCIES IN FOOD STORAGE WAREHOUSES IN 2000 The FDA sends warning letters to a food company if an inspection shows sanitation deﬁciency in the company’s processing operation. Four examples of such deﬁciencies from warning letters issued in 2000 are provided here. A.

Mobile, Alabama

During the inspection, our investigator documented numerous insanitary conditions, which caused the food products stored at your facility to become adulterated. The adulterated food products are in violation of Sections 402(a)(3) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, in that they consist in whole or in part of ﬁlthy substances, including rodent fecal pellets, and had been held under insanitary conditions whereby they may have become contaminated with ﬁlth. Evidence of rodent activity was observed in, © 2003 by Marcel Dekker, Inc.

on, and near foods stored in your warehouse and associated coolers. This evidence included rodent excreta pellets, rodent urine stains, and gnawed food products. Evidence of rodent gnawing was observed on several different food products, including honeydew melons and carrots. Our FDA laboratory conﬁrmed the ﬁndings of rodent excreta sampled from your facility during the inspection. Our investigation of the general storage conditions in the warehouse revealed: an approximate 0.5 ⫻ 7 in. opening to the outdoors at the bottom of the east wall and an approximate 0.75 ⫻ 4 in. opening to the outdoors at the bottom of the north wall in cooler number nine; an approximate 0.75 in. ⫻ 2 ft opening at the bottom of the west wall in warehouse number two; and an approximate 2.5 ⫻ 1 in. opening to the outdoors at the bottom of the east wall in warehouse number two, cooler number one. Other conditions documented during the inspection include observations of live birds and cats on and near foods stored in your warehouse. B. Washington, D.C. The violative conditions observed include 1. A dead rodent on the ﬂoor in the coffee/juice room 2. Examination of a commingled lot containing bagged wheat, cornmeal, and potato starch revealed a. Rodent excreta pellets inside a bag of semolina wheat b. Over 100 rodent excreta pellets on bags of rice, in spilled product, and on the pallet surface holding the bags c. Bird droppings on a box of cornmeal and a bag of potato starch 3. Rodent nesting material and rodent excreta pellets on a pallet holding canned eggplant 4. Rodent excreta pellets in the spice room 5. Rodent excreta pellets along the ﬂoor/wall areas of the jalapeno room 6. Rodent excreta pellets on the ﬂoor in the ﬂour room 7. Rodent excreta pellets, damaged and spilled product, and bits of insulation adjacent to a hole in the outside wall of the cooler 8. A live bird in the ﬂour room 9. Bird excrement on spilled product, on pallet surfaces and storage racks, and on boxes containing ‘‘Brand X’’ ﬂour 10. Ten dead adult and ﬁve moth larvae on spilled product from an unlabeled, damaged box in the spice room 11. Product spillage throughout the facility (jalapeno, spice, ﬂour, and coffee/juice rooms) 12. Storage of products against walls, no aisleways between products, clutter, debris, machinery, and metal parts stored along various walls 13. Gaps measuring 1 to 2 in. in length along the base of the outer bay doors 14. Thermometers in the walk-in freezers not calibrated or tested for accuracy C. Baltimore, Maryland Here is a list of insanitary conditions observed by investigators during an inspection of a warehouse and nut-manufacturing facility. 1. One live and 12 dead rodents in various locations throughout the facility. 2. Examination of a lot consisting of 17 50-lb bags of rolled oats revealed that © 2003 by Marcel Dekker, Inc.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12. 13.

D.

four bags contained ﬂuorescent stains. Three of the four ﬂuorescent stained bags contained apparent rodent-gnawed holes. Two of the three bags with the apparent rodent-gnawed holes also contained at least 30 rodent excreta pellets inside the bags with the product. Approximately 100 rodent excreta pellets were on the ﬂoor adjacent to the lot. Examination of a lot consisting of 30 boxes of lollipops (49 3-oz lollipops each) revealed that two boxes contained apparent rodent gnawed areas. Three lollipops in one of the boxes contained apparent rodent gnawing. Examination of a lot consisting of six boxes (24 10.6-oz packages each) of Popcorn Supply Kits revealed two boxes with apparent rodent evidence. One of the two boxes contained an apparent rodent-gnawed hole, ﬂuorescent stains, rodent excreta pellets on the box, and apparent rodent-nesting material inside the box. The other box contained an apparent rodent-gnawed hole and rodent excreta pellet at the opening of the gnawed hole. A lot consisting of eight cartons (6 6-lb 10-oz. cans each) and three individual cans of cheddar cheese sauce contained ﬂuorescent stains on the tops of two of the cans. There was apparent rodent-nesting material and rodent excreta pellets inside one carton. A lot consisting of 59 50-lb bags of popcorn kernels contained nine bags with ﬂuorescent stains, one bag with an apparent rodent-gnawed area, and four rodent excreta pellets on or adjacent to the bags. A lot consisting of eight cartons (6 5-lb bags each) of caramel candies contained one carton with apparent rodent gnawing. One of the bags in the carton had an apparent rodent-gnawed hole and one rodent excreta pellet on its exterior. Another bag had ﬁve rodent excreta pellets on its exterior. A lot consisting of approximately 600 50-lb bags of shell peanuts contained 14 bags with ﬂuorescent stains. Eight of the 14 bags contained apparent rodentgnawed holes. In some instances, the product itself bore ﬂuorescent stains or apparent rodent gnawing. At least 771 rodent excreta pellets were observed on the ﬂoors in various locations throughout the facility (main and rear warehouses, restroom, retail display area, and the basement). Structural defects were observed in at least six locations in the facility (gaps under doors, holes in the walls) affording points of rodent entry and/or harborage. There was a leaking drainpipe in the basement. Manufacturing equipment, such as the nut roasters and popcorn machines, contained accumulations of dust, dirt, debris, and/or rust. Only one of the two restrooms was operable, and neither had soap or other hand-washing solutions available.

Chicago, Illinois

The following sanitation deﬁciencies were observed during a food establishment inspection: 1.

2.

Rodent activity, in the form of rat excreta pellets, was observed on the roof of the ﬁrst-ﬂoor interior ofﬁce, in the third ﬂoor near packaging materials, and near a pallet of peppers in brine on the third ﬂoor. A rodent-gnawed bag of pancake mix and rodent-gnawed margarine packages,

© 2003 by Marcel Dekker, Inc.

3.

4. 5. 6.

7. 8.

all on the second ﬂoor, demonstrated penetration to, and potentially direct contamination of, product inside. A structural hole in the surface of the third ﬂoor (opening into the ceiling of the second ﬂoor) and another hole in a basement wall (near a pallet of cheese) have provided potential avenues of entrance/egress of rodents. A cat was noted running among stored food items on the second ﬂoor. Cat feces were observed in the basement next to a pallet of cheese and on a staircase between the second and third ﬂoors. In your ﬁrm’s rear courtyard, rat burrow holes (including one at the base of your building), a dead rodent, several ﬂies, containers with rotten eggs, overﬁlled trash dumpsters, unused manufacturing equipment, unidentiﬁed debris, and plant overgrowth were observed. Cheese and other perishable items refrigerated at an ‘‘unacceptable’’ temperature. Various products stored directly against walls in the basement and on the ﬁrst, second, and third ﬂoors.

ACKNOWLEDGMENT This chapter has been modiﬁed with permission from documents published by Science Technology System, West Sacramento, California.

© 2003 by Marcel Dekker, Inc.

24 Metal Detection ANDREW LOCK Safeline, Inc., Tampa, Florida, U.S.A.

I.

INTRODUCTION

At the end of World War II the ﬁelds of Europe were full of shrapnel and pieces of metal ranging in size from minuscule to immense. In order to remove these metal contaminants from harvested crops, such as potatoes, carrots, and beets, huge magnets were erected above conveyor belts. As time went by, an obvious need for other food products to be ‘‘metal detected’’ was identiﬁed and more sophisticated technology was developed, eventually evolving into the very specialized metal detection systems available today. While metal detection has always been important, and remains so today, there are of course other kinds of foreign materials that must be detected and removed before or during the manufacturing of food. The systems required to accomplish this are beyond the scope of this chapter, but some leads to the wider literature on the subject are given here. Campbell [1] and Graves [2] discuss the broader aspects of the problem of foreign objects in food (see also Chapters 5 and 6). Brennan et al. [3] consider only contaminants in raw ingredients. X-ray technology as applied to the detection of foreign bodies in food is now widely utilized in food processing facilities. Riva [4] has provided a detailed account of the principles of x-ray inspection. Graves [2] has applied these principles to food inspection. Bone fragments usually show up well on x-ray examination. However, in modern poultry production requiring shorter grow-out periods, chicken bones are less calciﬁed and are therefore more difﬁcult to detect by x-rays; the standard system is plagued by both false negative and false positives. To remedy this problem, a system developed at the University of Arkansas uses a combination of x-ray and laser imaging to reliably detect bone fragments in boneless chicken ﬁlets of varying thickness [5]. © 2003 by Marcel Dekker, Inc.

For descriptions of X-ray inspection techniques and all the other systems of foreign body detection in food, including the subject of this chapter, see Wallin and Haycock [6], Graves et al. [7], and Campbell [1]. Development of machines for the speciﬁc purpose of detecting unwanted metal in foods began in 1948 [6]. By 1980, the systems required to reliably detect metal fragments were largely in place [8]. The Guide to Reducing Metal Contamination in the Food Processing Industry, which now, with minor updates, becomes the present chapter, was ﬁrst published in 1990 and most recently revised in 1996 [9]. The focus of this chapter is quite narrow for two reasons: (1) because reliable systems of metal detection are so important in modern food processing, a detailed description of one such system seems amply justiﬁed and (2) although other systems of metal detection are available and reliable, the author’s technical expertise and experience are largely restricted to the system described in the remainder of this chapter.

II. DEFINING THE CURRENT PROBLEM Metal detectors are now accepted as essential equipment by most food and pharmaceutical processors. Many companies set strict standards for detector sensitivity. However, installing metal detectors will not necessarily guarantee a metal-free product; the detectors must be an integral part of a carefully planned and implemented metal detection program. The regulatory bodies in both the United States and United Kingdom have voiced strong recommendations for the universal inspection of all food products by metal detection equipment. ‘‘The extensive exposure of some products to metal equipment such as grinders, choppers, mixers, shovels, etc., causes the possibility of metal contamination . . . therefore the use of electronic metal detectors is highly recommended . . .’’ [U.S. Department of Agriculture (USDA) Technical Services]. Guidelines, issued by the Food and Drug Administration (FDA), update good manufacturing practices (GMPs) and offer more detailed guidance to the food industry to help ensure a safe and sanitary food supply. ‘‘Effectiveness measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this requirement may be accomplished by using sieves, traps, electronic metal detectors, or other suitable effective means’’ (Federal Register, Vol. 51, No. 118). A.

Sources of Contamination

The sources of contamination are so numerous that even the most stringent controls cannot prevent the occasional incident. Working practices described later in this chapter will minimize the likelihood of metal particles entering the production ﬂow and maximize the probability of reliably detecting and rejecting any that do. Contamination typically originates from these sources: 1.

2. 3.

Raw Materials. Typical examples: metal tags and lead shot in meat, wire and rust in wheat, screen wire in powdered material, tractor parts in vegetables, hooks in ﬁsh, staples and wire strapping from containers. Personal Effects. Typical examples: buttons, pens, jewelry, coins, keys, hair clips, thumbtacks, paper clips. Maintenance. Typical examples: screwdriver and similar tools, welding slag and swarf (metal fragments from lathe work) following repairs, copper wire

© 2003 by Marcel Dekker, Inc.

cut off during electrical repairs, miscellaneous items resulting from inefﬁcient cleanup or carelessness. 4. In-Plant Processing. Typical examples: broken screens, metal slivers from milling machines, foil from reclaimed products. Every time the product is handled or passes through a process, there is some risk of contamination. Crushers, mixers, blenders, slicers, and transport systems all contribute. Identifying the likely source of each contamination incident is an important part of developing an overall foreign material reduction plan. Inspecting raw materials will eliminate many large, easily detected pieces of metal that further processing may break into numerous difﬁcult-to-detect pieces. B. Why Are Metal Detectors Installed? To prevent damage to processing equipment To comply with stringent quality standards by major food producers/processors such as high volume retailers, fast food chains, and food service and vendor certiﬁcation programs To avoid the cost and implications of consumer complaints, adverse publicity, product recall, and litigation To win new markets and customers with high quality products To comply with FDA/USDA directives and legislation such as ‘‘due diligence’’

III. BASIC PRINCIPLES The most common types of metallic contamination in a broad range of industries include ferrous (iron), nonferrous (copper, aluminum, lead), and various types of stainless steel. Of these, ferrous metal is the easiest to detect—relatively simple detectors, or even magnetic separators, can perform this task well. Stainless steel alloys, used extensively in the food industry, are the most difﬁcult to detect, especially the common nonmagnetic grades. The nonferrous metals such as copper and lead fall between these two extremes. Only metal detectors using a balanced, three-coil system have the capability to detect small particles of nonferrous and stainless steel. The three coils are wound on a nonmetallic frame, each exactly parallel with the other (Fig. 1). The center coil is connected to a high frequency transmitter. The two coils on each side of the center coil act as receivers. Because these two identical coils are positioned equidistant from the transmitter, the identical signals they pick up induce an identical voltage in each (Fig. 2). When a metal particle (embedded in product) passes into the inspection port (aperture) of the detector, it disturbs the high frequency ﬁeld under one coil, changing (by a few microvolts) the voltage generated and disrupting the state of perfect balance. The resulting signal, processed and ampliﬁed, warns of the presence of unwanted metal. To prevent ambient electrical signals (e.g., from nearby metal items and machinery) from disturbing the detector, the three-coil setup must be mounted inside a metal case (usually aluminum) with an opening through the center to allow passage of the product. For some applications where frequent wash-down is required, the case may be constructed of stainless steel. The metal case, besides serving as a protective shield, gives strength and rigidity to the assembly, both crucial for satisfactory operation of the detector. © 2003 by Marcel Dekker, Inc.

Figure 1 A.

Three-coil metal detector.

Mechanical Techniques

Other special mechanical and electrical techniques are essential to overcome many practical difﬁculties. The metal case itself will have an effect on the state of balance. Microscopic movements (as small as 1 µm) of the coils relative to each other can cause an outof-balance voltage and a false ‘‘detect’’ signal. A major challenge for metal detector manufacturers is to design a totally rigid, stable system that will be unaffected by vibrations from motors, pulleys, auto-reject devices, temperature changes, and nearby machinery and vehicles; frame material, coil speciﬁcations, and case design are all crucial here. To further increase mechanical rigidity, some

Figure 2

Receiver/transmitter/receiver sequence.

© 2003 by Marcel Dekker, Inc.

manufacturers ﬁll the detector case with a material that prevents movement of the metal case relative to the coils, thus producing a unit that is able to operate at maximum sensitivity under typical factory conditions. B. Electronic Techniques While the mechanical techniques just noted work toward minimizing false signals from coil and case movements, the inﬂuence of other factors contributing to out-of-balance— temperature changes, build-up of product in the aperture, aging electrical components, minute alterations in the physical setup—can be countered by various electronic techniques, thus making ﬁne tuning by the operator unnecessary and ensuring long-term, optimal operation of the detector. Automatic balance control and quartz crystal control will not, by themselves, enable the detector to recognize smaller pieces of metal. They will, however, enable the detector to permanently maintain satisfactory sensitivity with no operator attention and without false reject signals. For high performance over an extended period, automatic balance control, quartz crystal control, and potted heads are all essential (all Safeline, Inc., heads are solid potted, meaning that the heads are ﬁlled with a dense material, the potting; foam potting is not used). C. Ferrous-in-Foil Detection When the product to be inspected is packaged inside an aluminum foil pack or dish, a balanced-coil metal detector cannot be used. Required here is a detector that ignores aluminum foil but is sensitive to small pieces of ferrous contamination (Fig. 3). As a metal particle enters the detector’s powerful magnetic ﬁeld, it becomes magnetized. Then, as it passes through the center coil, it generates a ‘‘detect’’ signal. D. Metal-Free Zone In order for a detector to operate properly, the space on each side of the aperture must be free from metal parts, rollers, and supports. As a general rule, this space should be approximately 1.5 ⫻ aperture height for ﬁxed metal structures and 2 ⫻ aperture height for moving metal such as reject devices or rollers.

IV. SENSITIVITY Many factors inﬂuence the operating sensitivity of a metal detector: type of metal, shape of metal, orientation of metal, aperture dimension, position of metal in the aperture, environmental conditions, product, operating frequency, and throughput speed. When trying to determine an operating sensitivity or compare capabilities of different detectors, the following three factors are vital: 1. The sensitivity must be maintained permanently without operator attention (an unstable unit requiring constant attention is useless). 2. The detector must not reject good product. 3. The detector must not generate false reject signals from vibrations and other external inﬂuences. © 2003 by Marcel Dekker, Inc.

(A)

(B)

Figure 3 Ferrous-in-foil detector showing (A) arrangement of magnets and (B) passage of food through a magnetic ﬁeld.

A.

Types of Metal

All metals fall into three main categories: ferrous, nonferrous, and stainless steel. Probability of detection depends on how easily they are magnetized and how readily they conduct electrical current (Table 1). Ferrous contamination, being both magnetic and a good electrical conductor, is eas-

Table 1 Characteristics of Metals Magnetic permeability

Metal type Ferrous (iron)

Magnetic

Nonferrous (copper, lead) Stainless steel (various grades)

Nonmagnetic Usually nonmagnetic

© 2003 by Marcel Dekker, Inc.

Electrical conductivity Good electrical conductor Generally good or excellent Usually poor conductors

Ease of detection Easily detected Relatively easily detected Relatively difﬁcult to detect

ily detected. Most metal detectors are able to detect small ferrous particles. Nonferrous metals such as copper, lead, and aluminum are nonmagnetic but, being good electrical conductors, are generally quite easy to detect. Stainless steel comes in many different grades, some magnetic and some nonmagnetic; conductivities vary. In the food-processing and pharmaceutical industries, 304L (EN58E) and 316 (EN58) are the two most common grades. Poor sensitivity to these grades is a major limitation of many modern metal detectors. The problem of detecting stainless steel becomes even more acute when inspecting wet or salty products. A good indication of a detector’s overall capability is the sensitivity ratio between ferrous and the most difﬁcult to detect grade (304L) of stainless steel. This ratio can be as good as 1:1.5 and as poor as 1: 2.5. A detector’s sensitivity predicts its ability to detect real-world contaminants, such as metal slivers and bits of screen wire, that exhibit an orientation effect. B. Shape of Metal Metal spheres are used as a standard to determine detector capabilities. There are two reasons for this; (1) spheres are available in a range of metals and diameters; and (2) a sphere has a constant shape no matter how it is presented to the detector (it has no orientation effect). The sensitivity of a detector is usually expressed as the diameter of a metal sphere of a speciﬁc metal type that is just barely detectable in the center of the detector aperture. C. Orientation Effect If a nonspherical particle of metal such as swarf or wire passes through a metal detector, it will be easier to detect when passing in one orientation compared to another. This is known as orientation effect. Figure 4 shows that a piece of ferrous wire is least detectable when it presents at 90° to the direction of ﬂow and most detectable when parallel to the ﬂow. Nonferrous and stainless steel wires are just the opposite. If this type of contamination is likely, care should be taken to ensure that the detector is, in fact, capable of detecting it. The orientation effect is only evident when the diameter of the wire is less than the spherical sensitivity of the metal detector. With the detector sensitivity set at 1.5 mm diameter, for example, only wires thinner than 1.5 mm diameter will show the orientation effect. If the detector sensitivity is increased to 1.0 mm, only wires less than 1.0 mm diameter will cause a problem. If the diameter of the wire is only about one-third the diameter of the detectable sphere, it may not be detectable whatever its length. Clearly, to minimize the orientation effect, it is better to operate the detector at the highest possible sensitivity. This, however, may cause other problems. As sensitivity levels increase, the problem of drift becomes more acute; with some detectors, nuisance false rejects will increase to an unacceptable level. The beneﬁt of a stable detector becomes even more important. Figure 5 compares a detector’s ability to detect three different wire samples at various detector sensitivities. The left-hand column shows four alternative sensitivities. As an example, when operating at 1.5-mm sensitivity, the piece of copper wire would need to be 9 mm long to guarantee detection. At a 2.0-mm sensitivity, this would increase to 26 mm. Small change in detector sensitivity will make a great difference in its sensitivity © 2003 by Marcel Dekker, Inc.

Figure 4 Effects of orientation: Detection is affected by the composition, shape, and orientation of the contaminating material—wire contaminant.

Figure 5 Comparison of detector sensitivity to spherical standards versus elongated, thin contaminants.

© 2003 by Marcel Dekker, Inc.

to wire pieces. The goal is to operate the detector at the highest possible sensitivity. Auto balance, quartz control, and a potted head all contribute to achieving this goal. D. Aperture Dimensions A large aperture is less sensitive than a small aperture. Both aperture width and aperture height inﬂuence the detector’s sensitivity. The geometric center is the least sensitive part of the aperture; the corners are the most sensitive; and all other points will lie somewhere in between. The sensitivity gradient (the difference between these two extremes) depends on the design of the coil and frame assembly. A large gradient may make the detector unduly sensitive to contamination in the conveyor belt or packing material. A perfect detector would have no gradient and would be equally sensitive at all points (Fig. 6). E.

Environmental Conditions

Metal detectors are inﬂuenced to varying degrees by environmental conditions such as ambient electrical interference, building vibrations, and temperature ﬂuctuations. These effects become even more acute when operating at high sensitivities. Ovens, freezing tunnels, and hot water wash-downs all create thermal shock that can result in false reject signals. Automatic balance control solves the problem, but lacking that, one solution may be to reduce the sensitivity of the machine. F.

Product

Because dry products such as confectionery and cereals are relatively easy to inspect, sensitivity curves can be used to calculate the expected operating sensitivities. When inspecting wet, conductive product, such as fresh meat, the situation is more complex. The wet product creates an interference signal in the detector that must be canceled out before inspection can begin. This tends to reduce the sensitivity of the detector in a way that cannot be calculated empirically. To minimize the effect, a lower operating frequency is often selected in the range 10–50 kHz. This reduces the interference signal from the product but also reduces the sensitivity of the detector, especially to stainless steel. Generally, actual product testing results show a slight improvement in ferrous sensitivity but a reduction in nonferrous and stainless steel sensitivity.

Figure 6 Effect of metal contaminant position as it passes through detector: (1) sensitivity is least in the center of the detector aperture; (2) position of intermediate sensitivity; (3) position (in corners) of maximum sensitivity; bar graph shows comparative sensitivities in relation to position in detector aperture.

© 2003 by Marcel Dekker, Inc.

G.

Inspection Speeds

Minimal and maximal inspection speeds are seldom a limiting factor for metal detectors, especially with conveyor-type applications. The limit will vary from manufacturer to manufacturer but will be a function of the detector aperture height. Typically this would be around 8 m/sec (1500 ft/min) for a 125-mm (5-in.) high aperture. More important than the absolute maximum and minimum is attaining uniform sensitivity over the full range of speeds. The limit of performance can be reached on pneumatic pipelines at speeds in excess of 35 m/sec (6000 ft/min) (this limit is not universal to all detectors). V.

INSPECTING WET OR CONDUCTIVE PRODUCTS

Products such as cheese, fresh meat, warm bread, jam, and pickles can create a signal in a metal detector even when completely free of metal. This ‘‘product effect’’ is caused by the salt or acid content making the product electrically conductive. To make inspection possible, it is necessary to eliminate or reduce the product-effect signal in one of three ways: 1.

2.

3.

Sensitivity Reduction. By progressively reducing the sensitivity of the metal detector, the signal from the product is made smaller and smaller until it is no longer detectable. Despite the detector also becoming less sensitive to all metals, it is usually the preferred option when product signals are small. Frequency Reduction. The operating frequency of a metal detector is generally in the range 10 kHz to 1 MHz. By selecting a frequency toward the low end of this range, the product-effect signal decreases. Unfortunately, the signals from nonferrous and stainless steel also decrease, causing the detector to be less sensitive to these metals. Product Compensation. Special electronic circuits can amplify and ﬁlter the signals from the detector by differing amounts according to their characteristics. The operator can adjust the ﬁlters to test a broad range of product signals. This technique, product compensation, has the general effects of minimizing the product signal, improving the detector’s sensitivity to ferrous metal, reducing sensitivity to nonferrous and stainless steel, and making the detector more prone to vibration from motors, reject devices, and other nearby machinery.

Inspecting conductive product is always a compromise and, in practice, a metal detector manufacturer will use a combination of all three techniques to give the best operating performance. The effects of vibration and drift from temperature variations are more pronounced on product-effect lines. Automatic balance control, quartz crystal frequency control, and potting the detector head will help create total stability. This overcomes a common problem, often experienced by users, of a gradual increase in the amount of rejected product which, when reinspected, is found to contain no contamination. Finding individual pieces of metal contamination in the rejected product is important for the following reasons: (1) if the source can be identiﬁed, then steps can be taken to prevent reoccurrence; (2) it can give early indication of the break-up of a piece of machinery; and (3) if line operators can see the results, it will help build conﬁdence in the machine. Rejected product should be reinspected during a break in production using either the original detector or a separate off-line unit. You must take care not to risk mixing the © 2003 by Marcel Dekker, Inc.

rejects with good product. If the product was originally frozen (such as hamburger) or has changed temperature (such as bread), it may not be possible to duplicate the original test conditions. Your company will need to decide how to proceed. Usually, a smaller off-line detector will be needed to test the broken-up product. To ﬁnd the individual piece of metal contamination proceed as follows: 1. For discrete items, the rejected product should be repassed through the detector three times in different orientations. 2. If no detection occurs, you may assume the product is not contaminated. 3. Remove any packing material and repass the product and packing material separately. 4. Split the product in half and pass each half through the detector. Repeat the process until the metal can be found. 5. After removing the metal piece, repass the remaining product to see if a second piece is present. 6. Keep the piece on ﬁle, with line and time information. A. Product Compensation—A Detailed Look The signals created by various metals as they pass through the coils of a metal detector can be split into two components, resistive and reactive, according to the conductivity and magnetic permeability of the metal. The signal from ferrous metal (iron) is primarily reactive; stainless steel is primarily resistive. The signals vary in amplitude (length) according to the size of the fragment of contaminating metal and in phase (direction) according to the resistive and reactive components that, in turn, depend on metal type. Signals from ferrous metals are larger than signals from the same size piece of nonferrous or stainless metal. Signals from vibration and outside interference always occur along the horizontal reactive axis. To improve sensitivity of the metal detector to the stainless signal and reduce the sensitivity to vibration, special circuits—phase sensitive detection (PSD) (Fig. 7)—are used to amplify the signals by differing amounts relative to phase. The PSD is shown as a long, thin oval called the detection envelope. For a signal to be detected, it must pass outside the detection envelope. Large signals from vibration are required before passing outside the envelope and thus being detected, while only small signals from stainless steel are necessary. This is the most satisfactory operating condition. A problem, however, occurs when inspecting a conductive product such as cheese. The large product signal (Fig. 8) passes outside the envelope and will be detected each time, even when the cheese is metal-free. By reducing the sensitivity of the detector, all the signals will become smaller until the product signal no longer emerges from the detection envelope. Inspection will then be possible. For small product effect this will usually be the preferable solution. An alternative solution is to electronically rotate the detection envelope until it is aligned with the product signal (Fig. 9). This adjustment, known as product compensation, can be carried out by the operator. Since the product signal no longer passes outside the envelope, normal inspection is again possible. Product compensation, however, has its drawbacks. Large signals from stainless steel are needed to pass outside the envelope, so the detector becomes less sensitive to these metals. At the same time, small signals from vibration will now pass outside the envelope and be detected. © 2003 by Marcel Dekker, Inc.

Figure 7 Vector diagram of varying signals of several different kinds of metals, passing through a metal detector. Undue sensitivity to vibration is often the limiting factor when inspecting with product compensation. The exact phase of any product cannot be calcuated from data on salt content or on pH; neither can detection sensitivities be calculated. Product testing, usually available from metal detector manufacturers, is essential to determine the detector’s sensitivity to a range of metals. B.

Automatic Product Compensation

Accurately adjusting the product compensation control requires operator competence if optimal performance is the goal. If a number of different products or pack sizes are to be checked on the same production line, adjusting the detector for each new product can be time consuming. The recent introduction of microprocessor-based metal detectors has

Figure 8

Phase sensitive detection: signals from vibration are minimized, while signals from stainless steel are maximized; only signals passing outside the detection envelope (long, slender oval) can be detected.

© 2003 by Marcel Dekker, Inc.

(A)

(B)

Figure 9 (A) Conductive products may produce false positive signals, indicating metal contamination where none exists. (B) Product compensation can be achieved by electronically rotating the detection envelope so that signals generated by the product itself are contained within the detection envelope.

resulted in major improvements when inspecting conductive products. By switching to ‘‘learn’’ or ‘‘automatic compensation’’ mode product compensation can be set automatically, with no operator involvement. These settings can then be entered into a memory to allow immediate recall when changing product, or even to allow remote setup of the detector from a central computer. VI. CONVEYOR AND REJECT SYSTEMS A metal detector conveyor is much more than a modiﬁed transport conveyor. The conveyor system that transports the product through the detector must meet certain strict criteria, if it is to avoid inﬂuencing the detector. The design of both conveyor and auto-reject device will have a major impact on the effectiveness of the overall metal detection program. Unless special precautions and design techniques are incorporated, eddy current loops and static build-up can inﬂuence the detector, downgrading sensitivity and causing interference. Metal detectors emit high frequency signals that generate tiny eddy currents that ﬂow all around the metal structure of the conveyor. These eddy currents have no effect on the detector if they remain constant. However, if the conveyor structure has an intermittent © 2003 by Marcel Dekker, Inc.

(bolted) joint of variable resistance, even remote from the detector, the eddy currents brieﬂy change and send large interference signals to the detector. Typical sources of eddy current loops are any metal-to-metal contact such as a bolted conveyor assembly or supports, pulley shafts and bearings, chain drives and guards, rejectdevice supports, and metal conduit clamps. Frequently, oxidation of joints or changes in bearing lubrication cause problems to increase with time. A.

Belting Types

Several factors need to be considered in choosing a suitable belting material. Static charges can build with some types of materials, as when running over plastic skid plates, and plastic-coated rollers and pulleys. Special antistatic belting, often made with conductive carbon ﬁllers or additives, can adversely affect the detector’s performance, especially when the belt joint passes through the aperture. With any type of belt the joint must be metal-free and made in such a way as to prevent product build-up or an accumulation of grease. Metal fasteners or sewn and laced joints are unsuitable. The belt material itself must also be totally metal-free. Because tiny metal specks in the material are extremely difﬁcult to ﬁnd, belt manufacturers producing consistently high quality, metal-free belting would almost certainly need to use metal detection equipment to inspect their raw materials. Flat, dished, ribbed, cleated, and molded ﬂexible wall belts are all acceptable. Solid plastic chain belts of the ‘‘Intralox’’ style and round urethane belting running in grooved rollers are ideal where spillage requiring frequent wash-down is likely. Endless ‘‘double pass’’ belts (Fig. 10) offer a number of advantages in many applications, including rapid replacement. However, because the face of the belt passes over rollers, they are not suitable for transporting wet or sticky product such as meat trimmings. B.

Product Transfer

The process of transferring product onto the conveyor system needs special consideration when the end rollers are large or the product is small. If the distance (D) between rollers is more than half the product length, reliable transfer will not be possible. Installation of

Figure 10

Metal detector conﬁgured with a double-pass (endless) conveyor belt.

© 2003 by Marcel Dekker, Inc.

small, nonpowered, intermediate rollers or a dead plate positioned between the two rollers is usually effective (Fig. 11A). Single or double knife edges (Fig. 11B) permit transfer of very small items where product registration (repeatability of the physical position of the product as it passes through the metal detector) has to be retained, such as rows of confectionery at the outlet of an enrober. Sticky product such as raw dough and meat and bulk loose product such as loose peanuts can be transferred by cascade (Fig. 11C). For jar inspection, the detector system may be positioned alongside the existing transport conveyor; product guides divert the jars from the line onto the detection system. Acceptable products are then diverted back. When a contaminated item is detected, the product guide moves pneumatically to reject the item from the line (Fig. 11D). C. Transfer Speed To allow easier identiﬁcation of the contaminated items, it is often useful to accelerate the product through the detector to create an increase in product spacing. When packs are very close, the detector may be unable to determine which one is contaminated. Two or three packs may need to be rejected to be sure of catching the right one. By increasing the detector conveyor speed, product spacing is increased, permitting the individual items to be identiﬁed. When inspecting bulk and loose product, the burden height can be reduced by accelerating the product on transfer. This has the advantage of minimizing the volume of rejected product and permits a lower detector aperture, resulting in higher sensitivities (Fig. 12). D. Automatic Rejection Systems Ineffective reject systems are probably the weakest link in most detection programs, resulting in contamination not being effectively and reliably rejected from the line. A correctly speciﬁed system should be foolproof and capable of rejecting all contaminated product under all circumstances, independent of the frequency of occurrence or the location of the metal inside the product. Occasionally, automatic rejection is not used. The operator is expected to remove contaminated product when the conveyor stops on detection, or at the sound of a bell, or when a bright plastic disc drops on the line from an electronic ‘‘disc dropper’’ designed to operate each time metal is detected. All these solutions are high risk since they depend entirely on the efﬁciency of the line operator. The choice of the most appropriate reject system depends on a number of factors; advice of the detector manufacturer should always be sought. Options available include 1. 2. 3. 4. 5.

Air blast—ideal for light, single-line product (Fig. 13A) Pusher/punch—single-line discrete, spaced, and oriented product (Fig. 13B) Sweep/diverter arm—random, nonoriented product (Fig. 13C) End ﬂap—bulk or discrete multiple items on wide belt (Fig. 13D) Retracting belt—end pulley retracts to create a gap in the line; very reliable on most applications (Fig. 13E) 6. Reversible belt—ideal for bulk, random, or sticky products (Figs. 13F,G) © 2003 by Marcel Dekker, Inc.

Figure 11

Product transfer systems: (A) 1—successful transfer achieved only if product length is at least D (distance) ⫻ 2; 2—transfer assisted by an intermediate idle roller. (B) Single and double knife edge conﬁgurations are useful for very small product items. (C) Product transfer systems: the cascade conﬁguration is useful for sticky product or bulky, loose items. (D) Product transfer systems: metal detector signals diversion of rejected item (marked with X) away from acceptable product (product ﬂow is from left to right).

© 2003 by Marcel Dekker, Inc.

Figure 12 Running the detector conveyor at a faster speed (V2 ) than the transfer conveyor (V1 ) allows for a thinner layer of product to pass through the detector and thereby increases detector efﬁciency.

E.

Inspection of Liquids

Inspection of pumped liquids and slurries can be achieved by replacing a short section of the stainless steel transport pipe with a food-quality plastic pipe and passing it through a metal detector (Fig. 14A). On detection of metal, a sanitary three-way valve diverts the contamination; alternatively, the pump can be stopped and the contamination ﬂushed out manually. Typical products suitable for pipeline inspection include liquid chocolate, ice cream, soup, and meat slurry. For product likely to solidify if pumping stops, such as liquid chocolate, the throughput pipe can be equipped with a hot water jacket (electric wire wrap heating cannot be used). Hot water jackets also prevent an accumulation of fat inside the pipe when pumping certain types of sausage meat emulsions. Pumped product is seldom totally homogeneous. Voids and bubbles frequently occur, causing problems when adjusting the detector for optimal performance, especially for highly conductive products. Under normal conditions, because product is passing under all coils of the detector, product effect tends to ‘‘cancel out;’’ the detector can then be adjusted to give high sensitivity. If, however, a void or bubble passes under the ﬁrst coil, the detector will sense a large product difference, prompting a false reject (Figs. 14B,C). It is possible to adjust the detector to eliminate the product signal, but unless the bubbles occur frequently or at a predictable time (such as with a pump startup) it may take a long time. In these instances, automatic product compensation will be of no help. F.

Inspection of Powders and Granules

Any free-ﬂowing powder or granule-type product, such as peanuts, rice, plastic pellets, milk powder, and cocoa beans, can be inspected under free-fall conditions using a gravityfeed, free-fall detector and a high-speed diverter valve. Under normal conditions, there are no moving parts such as motors, gears, rollers, or belts, and, with the relatively high volumes that can pass through a small detector opening, very high sensitivity can be achieved. © 2003 by Marcel Dekker, Inc.

Figure 13 Automatic rejection systems (• indicates metal contaminant in product). (A) air blast; (B) pusher/punch; (C) sweep arm; (D) end ﬂap; (E) retracting belt; (F) reversible belt; (G) reversible belt.

The detector and auto-reject device should be mounted on a rigid framework with sufﬁcient space between them to ensure that metal contamination is always rejected (Fig. 15A). Product ﬂow may be continuous free-fall or batch free-fall. The application is not suitable when product backs up in the throughout pipe and moves slowly. The overall system height is often a limiting factor in the use of gravity feed systems, © 2003 by Marcel Dekker, Inc.

Figure 13 Continued © 2003 by Marcel Dekker, Inc.

Figure 14 Inspection of liquid foods. (A) Product passes through the detector by means of a plastic pipe; contaminants are ejected upon signal to a rejection device. (B) Conduit pipe should be completely ﬁlled to avoid false reject signals from the product itself. (C) Bubbles or other voids in the product cause false rejects. especially where little headroom exists. The following limiting variables have a direct relationship on the overall system height. 1.

2.

Initial Fall Height of the Product. This will determine its velocity at the point of inspection and also the time taken to arrive at the reject point. The fall height should ideally be reduced to a minimum by locating the equipment as close as possible to the point of initial fall. Detector Aperture. This will determine the metal-free zone of the detector and, in turn, the height of the input ﬂange above the detector and the closest

© 2003 by Marcel Dekker, Inc.

Figure 15 Inspection of dry products. (A) Gravity-feed, free-fall detector with high-speed diverter valve (• indicates metal contaminant in product). (B) Auger-fed system utilizing a proprietary zero meal-free zone (ZMFZ) detector.

point at which the reject device can be located. The aperture height will also determine the distance the reject chute must travel to reject product. 3. System Response Time. This covers the speed of response of the relay or solid-state output, air solenoid or air cylinder and the time taken to move the reject ﬂap to the reject position. 4. Reject Angle. The reject angle must not be so large as to create blockage or bridging. As the length of the reject ﬂap is reduced, the reject angle increases. An angle of between 25 and 30° is considered a maximum for most products. 5. Reject Design. Product build-up on the reject device, a drop in air pressure, and aging of bearings all slow down the speed of response. A sufﬁcient safety margin is needed in the design to ensure that metal is rejected with total reliability. G.

Special Applications

Installing a custom-designed metal detector as an integral part of a packaging or processing machine can have a number of distinct advantages for both the user and the supplier of the original machinery.

© 2003 by Marcel Dekker, Inc.

1. Pouch Filling Detectors can be installed to inspect powdered material prior to ﬁlling in preformed aluminum pouches. Apertures of 50 mm (2 in.) or 75 mm (3 in.) are usually sufﬁcient, but space limitations restrict the exterior case dimensions. Severe metal-free zone restrictions occur because of the metal parts of the auger ﬁllers. Up to three ﬁllers—hence three detectors—may be needed on a single pouch maker. 2. Vertical Form Fill Seal A special detector can be ﬁtted between a computerized weight scale and a vertical form ﬁll seal (VFFS) bagger (Fig. 15B). Often a large detector, 150 mm (6 in.) or 200 mm (8 in.), is required, which would require a large metal-free zone. This detector technology allows high sensitivity levels to be maintained in minimal space without false rejects, making installation easier and avoiding the danger of product breakage. The entire line may be stopped when metal is detected.

VII. ESTABLISHING AN EFFECTIVE METAL DETECTION PROGRAM Metal detectors may be used at various stages of a production process. 1.

2.

Bulk Inspection. Eliminates metal before it can be broken into smaller pieces; protects processing machinery from damage; avoids the product and packaging waste that happens when a ﬁnished, high-value product is rejected. Typical examples include bulk inspection of meat blocks prior to grinding, ingredients for pizza toppings, and grain. Finished-Product Inspection. No danger of subsequent contamination; ensures compliance with quality standards.

A combination of bulk and ﬁnished product inspection gives optimal protection. Selecting a reliable metal detection system is just the ﬁrst step in achieving the ﬁnal objective; minimizing, or eliminating the incidence of, metal contamination. Those responsible for establishing and monitoring the program should make sure that the proper procedures are clearly speciﬁed and implemented and that the line operators and general work force are aware of them. A.

Sensitivity Standard

Establishing a sensitivity standard, while relatively easy for producers of small dry items such as confectionery, can be more difﬁcult when a wide range of ‘‘product-effect’’ lines are in operation. Agreeing to a company standard minimum for ﬁnished-product inspection will help overcome the possibility of a detector being installed at the wrong place in the production line. An example is where inspection of ﬁnished cases is being considered instead of inspecting each individual item. The larger detector would achieve lower sensitivity, and frequently occurring metallic specks in the carton material would limit the detector’s capabilities. Equipment should be operated at its maximum reliable level; this may be better than the agreed-upon standards for some applications. It is, however, more important for equipment to work reliably, long term, and without false rejects, than to try to achieve a © 2003 by Marcel Dekker, Inc.

Table 2

Standards for Dry, Nonconductive Products

Detector height

Fe/Non-Fe Nonmagnetic stainless steel

Up to 50 mm (2 in.) Up to 125 mm (5 in.) Up to 200 mm (8 in.)

0.8 mm 1.2 mm 1.6 mm

1.2 mm 1.6 mm 2.2 mm

better sensitivity and create false alarms. For dry, nonconductive products, see Table 2 for the standards used by many food processors. Standards for very wide detectors, such as those used at the outlet of ovens or enrobers, may need to be slightly lower than those given in Table 2. For conductive products, product testing is needed to determine detection capabilities. Test results, however, should be considered only as estimates. Both the acceptable standard minimum and the individual line speciﬁcation should be determined for both ferrous and nonmagnetic stainless steel. The line speciﬁcation should be marked clearly on the side of the detector and metal samples of the correct diameters should be available for testing. Only authorized personnel should have access to the detector controls. B. Testing the Detector Testing the metal detector with standard test samples should be carried out regularly to conﬁrm both detection and reliable rejection. The interval between tests will depend on the implications of a failed test (see next section). A typical routine would be to test every 2–4 hr and at the beginning of each shift. If maintenance or repairs have been carried out on the line during downtime, the metal detector must also be checked prior to line start up. It is important to follow correct procedures. 1. Use correct test samples of ferrous and stainless steel mounted in a plastic card or plastic block. 2. For discrete items, place the metal sample at the front of a well-identiﬁed product and run it through the detector; make sure it breaks the photogate or other reject device. 3. For bulk product, place the sample in the product ﬂow. 4. Conﬁrm the product with sample is detected and rejected. 5. For discrete items, repeat the test with the sample at the back of the product. A more demanding test is to use two samples, properly spaced, to ensure multiple rejections. Precautions must be taken to ensure that any test samples not rejected do not become ‘‘lost’’ in production. If the detector is positioned just prior to another processing machine, such as a grinder or mixer, it is wise to attach the test sample to a piece of string. C. Action Required If Test Fails If the test sample is not detected or rejected, all output since the last successful test should be considered suspect and possibly contaminated. The cause of failure should be determined. If the failure is the result of tampering or a change in production conditions, proce© 2003 by Marcel Dekker, Inc.

dures should be established to prevent reoccurrence. If the detector can be adjusted to bring it back to correct operation, this should be done and noted on the test log. If a test shows that a system is faulty, the user must decide what course of action to take. Several options are available: 1. 2. 3. 4.

Continue production and repair the system as soon as possible. Continue production and reinspect product through an off-line system. Stop production. Stop production and reinspect everything produced since the last successful test. If this is not possible, quarantine warehoused product.

Only by stopping production, and preferably reinspecting product, can a company be conﬁdent that an effective metal detection program is in place. A corporate policy should be agreed upon and publicized ahead of time. The value of taking this position is evident in the event of a complaint or litigation. The temptation to keep production lines running uninspected can be reduced if the metal detector is equipped with an electronic module that, without special skills or specialized equipment, can be easily replaced by an operator. D.

Treatment of Rejected Product

All rejected product should be reinspected in the same detector during a break in production, or in a separate off-line detector, to locate the offending metal piece. For discrete items, the following procedure is suggested: 1.

2. 3. 4.

The contaminated items should be passed three times through the detectors in various orientations. If there is no detection, the item can be considered acceptable. If the item is detected, remove any packing material and repass. Divide product into smaller and smaller pieces until metal can be located. Do not try to locate metal visibly by spreading product on a table, you will not be successful.

Metal particles found should be shown to line personnel so they build up conﬁdence in the equipment and then kept for future reference and details recorded in a ‘‘Metal Contamination Daily Log’’ (Fig. 16). If the source is known, it should also be recorded. If not, investigations are extremely useful in preventing a reoccurrence and can result in a change in maintenance procedures or even a change in raw material suppliers. Locating and retaining the particles has the added advantage that if a screen or blade, for example, is known to have broken into the product, the individual pieces detected can be collected and the component ‘‘reassembled’’ to ensure nothing has been missed. E.

Performance Validation

A metal detector with a performance validation routine (PVR) can help ensure testing is carried out properly at agreed time intervals with proper test samples and, if required, provide hard copy documentation conﬁrming the test. Approved personnel enter a personal access number into the detector and then carry out the test with the correct sample size. Hard copy documentation (Fig. 17) showing that testing has been carried out can © 2003 by Marcel Dekker, Inc.

Figure 16 Sample metal contamination daily log.

be provided through a local printer or downloaded to a central computer with detector network capability. ‘‘Proof of Inspection’’ (Fig. 17) is useful evidence in the event of a customer complaint and to conﬁrm compliance to an inspection standard in a vendor certiﬁcation program. F.

Detector Networking

Microprocessor-based metal detectors may be networked together and linked back to a central computer. This provides the user with two important beneﬁts. 1. Real-Time Status. By glancing at the computer monitor, a supervisor may be immediately reassured that all detectors are operating properly and have been recently tested. Warning ‘‘ﬂags’’ can be displayed and corrective action immediately taken if a sudden increase in rejections occurs, if a detector fails, or if metal is detected but the reject device fails to remove it. 2. Accurate Documentation. All events such as rejections, faults, setup changes, and quality assurance (QA) tests are stored in a database with the time and date they occurred. The information may be viewed or printed out in various report formats. In the event of a complaint, a printout can prove the product was inspected by a detector that was properly adjusted as well as conﬁrm when and who tested the unit with test samples. © 2003 by Marcel Dekker, Inc.

Figure 17

Sample daily metal detection test sheet.

VIII. REASONS WHY YOUR PROGRAM MAY FAIL Relatively few incidents of metal being undetected are a result of detector failure. They are usually associated with poor working methods by company employees and faulty system design. Often the complaints do not result from tiny metal pieces but from larger items such as washers, bolts, and pieces of blades and screens that should be detectable by even the most basic type of detector. There will always be a limit to the smallest metal piece detectable; processors should ensure that this limit is understood and acceptable in their operation. © 2003 by Marcel Dekker, Inc.

A. Conveyor Design The design and method of manufacture of the conveyor will have a great inﬂuence on the detector. It is an integral part of the complete inspection system and, in almost all cases, the detector’s maximum sensitivity cannot be achieved when ﬁtted to an existing general-purpose transport conveyor. Fully welded structures, incorporating correct, metalfree zones and properly isolated rollers, pulleys, cross-structures and detector-head mounting, are essential to obtain the highest reliable performance. Conveyor belting must be metal-free to a very high standard and suitably jointed. Antistatic belting should be avoided. If these problems are not solved at the onset, the common outcome is a gradual increase in false rejects. B. Nonpositive Reject System This is probably the weakest link in the whole inspection system. Common problems are (1) reject device not suitable for the application; (2) system design not capable of removing consecutive contaminated packs; (3) failure of the reject device due to low air pressure, solenoid failure, or blockage; (4) downstream product backup through the detector; and (5) product spacing and reject-device design not compatible. A major beneﬁt (illustrated by the following case study) of single-source responsibility for conveyor, reject device, and metal detector is that all of these issues can be addressed at the design stage. A frozen pizza manufacturer was using eight identical detector systems with air blast rejection but no photogating. The equipment was tested each hour by placing the test sample, in the center of the pizza; each time the test was successful. A consultant suggested that the test be repeated with the test sample on the front edge of the pizza. The QA manager was amazed as he watched the pizza in front of the test sample get rejected and the contaminated sample continue down the production line. The reason for the ongoing customer complaints became clear. Simple, readily available control devices could have been installed to make sure the reject device was operating properly and that contaminated packs were always rejected. C. Production Continuing When the System Is Faulty A ﬁrm policy should be established dictating the action required in the event of a detector fault. Halting production is the safe option. Alternatively, product can be stored for subsequent inspection in an off-line unit prior to release. If your detectors have user-replaceable, quick-change modules, a repair can be effected in minutes and the temptation to keep running, without functional detectors, avoided. The drive motor of the conveyor can be wired to stop or the reject device set to operate continuously in the event of detector failure. Automatic self-checking is an essential feature of any metal detector. Its purpose is to continually monitor the detector and give an alarm if it fails or if the sensitivity falls. This automatic checking can be extended to cover all associated items such as reject mechanisms. D. Rejected Product Returned to Production If product is rejected onto the ﬂoor or into an open container, it can be easily returned to production in error or, when production schedules are tight, intentionally. Rejection into lockable reject bins helps overcome the problem. A warning device should be incorporated to indicate when the bin is full. Frequent false rejects and erratic operation can undermine © 2003 by Marcel Dekker, Inc.

the operator’s conﬁdence in equipment. In contrast, showing line operators the various metal pieces found will build conﬁdence in the equipment. Most microprocessor equipment will display the number of rejected items on the control panel; this should be compared to the actual number found. Good recordkeeping will highlight those lines or shifts that seem to have suspiciously few rejects. E.

Line Operators’ Working Practices

To prevent the detector being switched off or reduced in sensitivity, access to the controls should be restricted to QA personnel or to a responsible supervisor trained in the adjustment of the machine. Other problems sometimes encountered include air supply to reject device disconnected, reject bin overfull, and reject arms tied open with string. Simple checking devices are available to monitor all system components. F.

Conveyor System Used as a Pack-Off System

On production lines where all the products are taken off the conveyor by hand, the reject device should be positioned as close as possible to the detector and the space in between covered with a clear guard. This prevents contaminated items from being removed (by mistake) before they have arrived at the reject point. G.

Subsequent Contamination After Inspection

For QA applications, the ideal point of inspection is immediately after packing or as close to ﬁnal packing as possible. When the packaging material includes aluminum foil, inspection can be done before packing with a ferrous-type detector or after packing with a ferrous-in-foil detector. The latter is recommended only when no alternatives are available because ferrous-in-foil units cannot detect stainless steel and nonferrous metals. Intentional metal contamination is very difﬁcult to prevent. Inspection as late as possible in the process and minimizing the access to ﬁnished product will help. Employees under notice of termination should not be allowed in sensitive production areas. If sabotage is of particular concern, discussions with the metal detector manufacturer are likely to prove worthwhile. H.

Users Unaware of Detector Limitations

Many operators are unaware of the practical limitations of the detectors they use. A detector working at a 2-mm sensitivity, for example, will not necessarily detect all metal pieces larger than 2 mm. A thin piece of screen wire could be 25 mm (1 in.) long or more and still pass undetected. An understanding of the orientation effect will prevent onset of a false sense of security. This understanding can inﬂuence the location of the detector in the production process and prevent it from being installed to perform a task for which it is unsuitable. Even slight reductions in operating sensitivity can have a signiﬁcant effect on the performance of the detector, a point seldom appreciated by the user. I.

Detector Drift

Detector drift, resulting in changing sensitivities, false alarms, or nuisance signals, occurs over a period of time due to temperature and humidity variations, aging of electronic © 2003 by Marcel Dekker, Inc.

components, and build-up of product in the aperture. Typically, sensitivity to ferrous metal improves, and sensitivity to nonferrous and stainless steel diminishes. For this reason, it is always important to routinely test the detector with all three types of metal. Quartz frequency control and automatic balance control will go a long way toward eliminating drift and ensuring constant sensitivities. IX. DEVELOPING A METAL CONTAMINATION CONTROL SYSTEM Money spent reducing complaints inevitably yields a better return than money spent answering them. The real value of a quality program is determined by its ability to contribute to proﬁts and to customer satisfaction. An argument for quality improvements is often weak when it has to deal in generalities and opinions. It becomes more convincing and realistic if it can quantify the costs and savings. These costs can generally be split into three broad areas: 1. Prevention Costs. These highly cost-effective measures cover items such as supplier capability surveys, employee education and training, and establishing GMPs—all activities speciﬁcally designed to prevent contamination or defects. 2. Appraisal Costs. These costs, associated with testing, inspection, and ongoing evaluation of the production process, are necessary to ensure conformance with quality standards. 3. Failure Costs. These costs, potentially the highest by far, cover failures occurring both before and after shipment of product. A metal-contaminated product found before shipment is a failure resulting in product and packing wastage, possible machinery damage and loss of output; if found only after shipment, the results may be loss of customer satisfaction, product recall, adverse publicity, and potential lawsuits. Prevention and appraisal costs (generally low) are incurred because poor quality controls may exist. Failure costs (generally high) are incurred because poor quality controls do exist. An integrated approach—carefully set up, rigorously followed, proactive rather than reactive, and used to prevent contamination rather than just detect it—must be developed and melded into the total QA program. Responsibility for quality should include suppliers in order to ensure their standards are equally demanding. Often contamination in the supplier’s product is more easily detected before it is further processed and broken into smaller pieces. The objective should be to have control over the whole production process—the incoming raw materials, the environment, the processing, and the packaging. As a ﬁrst step, a Foreign Material Task Force should be formed to develop, implement, and coordinate the foreign material control system. Ideally, it should include senior personnel from production, QA, engineering, and maintenance. The Task Force has three main responsibilities: (1) establishing and monitoring CCPs; (2) developing GMPs; and (3) providing documentation and trend analysis. A. Critical Control Points Conducting a hazard analysis and establishing critical control points (HACCP) are important ﬁrst steps in taking a proactive step toward reducing contamination. A ﬂow diagram should be developed showing the trafﬁc pattern of all products in each production stage, © 2003 by Marcel Dekker, Inc.

from the incoming raw materials to the ﬁnal warehousing of ﬁnished product. Depending on the complexity and number of different processes, as many as ten separate ﬂow diagrams may be required. Every point in the product ﬂow should be considered and each one that might create a potential hazard is identiﬁed as a CCP. After each CCP is coded, the method and frequency of checking are determined. Control points are established not only where metal contamination hazards are possible, but also for any other quality-related matter. B.

Good Manufacturing Process

In addition to identifying CCPs, other potential sources of contamination, not related directly to the production process, need to be identiﬁed and procedures introduced to eliminate danger. Examples follow: 1,

2. 3. 4. 5. 6. 7. 8. 9.

Speciﬁcations for incoming raw materials should state that they are required to be free from foreign body contamination and should indicate speciﬁc precautions required of the supplier. Procedures would depend upon product type, such as powdered material to be screened and passed through a detector, carcass meat should not be labeled with metal tags, and containers should not be stapled. Paper clips should not be used on documents in production areas. No thumbtacks should be used on any notice board. No hair clips, watches, jewelry should be allowed in production areas. Protective clothing should have no outside pockets; laundered items are to be checked for loose buttons prior to reissue. Only magnetic ‘‘Band-Aid’’ wound dressings to be used by personnel (to aid detection of lost dressings. Conveyor lines carrying open containers should be covered until the containers are closed or capped. Holding containers should be covered. Step bridges over production lines should have enclosed sides and should be checked regularly.

Many other speciﬁc effective measures can be carried out relevant to particular industries and manufacturing processes. Effective training is fundamental for all involved, from those who design plant layout to the production-line operator—all must have a commitment to the avoidance of foreign bodies. Programs should include an explanation of the company’s QA philosophy and details of the CCPs. Documentation and reporting procedures should be detailed and individual responsibilities for reporting potential hazards such as defective machinery made clear. Poor maintenance practices are often related to metallic contamination. Lists of routine and preventive maintenance tasks that can be performed outside normal production hours should be drawn up and regularly updated. Other effective procedures include (1) equipment maintenance, especially welding and drilling, should not be done when production lines are operating; screens should be provided to prevent spread of welding slag and swarf; (2) for major work on new installations, complete ﬂoor to roof screens should be used; (3) magnetic mats, brushes, and vacuum cleaners should be used for cleanup and on repaired equipment prior to returning the equipment to the production area; (4) startup © 2003 by Marcel Dekker, Inc.

team responsibilities, with particular emphasis on CCPs, should be detailed; and (5) on completion of any repairs or installations, a member of the QA team should inspect the plant and surrounding area. Implementing proper procedures and working practices can help make the ‘‘quality philosophy’’ permeate the whole company. Appropriate channels for rapid feedback and revision, in light of new experience, will keep the systems ‘‘live.’’ Every piece of metal that is prevented from entering the production process represents success. C. Documentation and Trend Analysis The effectiveness of monitoring CCPs can be reliably determined by efﬁcient collection of data and by trend analysis. The importance of recording each incident of metal contamination has been noted. Trend analysis of contamination type and frequency, line by line or machine by machine, can identify speciﬁc sources of trouble such as a raw material supplier, production staff or shift, and inadequate maintenance. Using this information over a period of time will help determine the effectiveness of the QA program and, equally

Figure 18 Sample metal detection policy. © 2003 by Marcel Dekker, Inc.

important, will be the ﬁrst step in quantifying, in monetary terms, the savings or increased proﬁts generated. Monitoring the CCPs should result in a signiﬁcant reduction of contamination defects in a short period of time. Two different trend charts are used: one to record the number of pieces of metal contamination detected on a weekly basis, the other to track the number of consumer complaints. Each incident should be investigated to determine if the failure is a result of ineffective monitoring of the CCPs, if a new, previously unidentiﬁed CCP is responsible, or if the metal particle is smaller than the operating capability of the metal detector. X.

WHAT TO DO IF THE TEST FAILS

A company’s metal detection policy (see Fig. 18, for example) should be deﬁned and publicized. In addition, whenever possible, you should require your raw material suppliers to adopt a similar policy so they do not ship you contaminated product. Many major corporations now make metal detection a part of their Vendor Certiﬁcation Programs. If a metal detector failure occurs, causing production to be stopped until a factory-trained technician can schedule a service visit, the loss of output will be substantial. Alternatively, if production continues, your metal detection program will be compromised and you cannot be certain of producing a metal-free product. One of the great beneﬁts of using metal detectors that incorporate a universal, quickchange electronic module, designed for fast and easy replacement, is that it minimizes service costs (which may be relatively minor when compared to the cost of lost production). But, more importantly, it avoids the temptation to run a production line unprotected, without the beneﬁt of a functional detector. Outside audits of equipment, performed by certiﬁed quality auditors, are an additional service that is available to assure users that equipment is in compliance. Experienced metal detection experts can often spot potential problem areas and suggest solutions before they become apparent to the user. REFERENCES 1. A Campbell. Guidelines for the prevention and control of foreign bodies in food. Guideline No. 5. Chipping Campden, England: Campden & Chorleywood Food Research Association, 1995. 2. M Graves. X-ray machine vision for on-line quality control in food processing. Ph.D. dissertation, University of Cardiff, Cardiff, Wales, 1999. 3. JG Brennan, JR Butters, ND Cowell, AEV Lilley. Food Engineering Operations, 3rd Ed. London: Elsevier Applied Science, 1990. 4. G Riva. Principles of x-ray inspection. REC 4142, Part No. 067336. Markham, ON: Thermo Electron Corporation, 2000 [available only from the author at [email protected]]. 5. Y Tao, JG Ibarra. Thickness-compensated x-ray imaging detection of bone fragments in deboned poultry—model analysis. Trans Am Soc Agric Eng 43(2):453–459, 2000. 6. P Wallin, P Haycock. Foreign Body Prevention, Detection and Control: A Practical Approach. London: Blackie Academic & Professional, 1998. 7. M Graves, A Smith, B Batchelor. Approaches to foreign body detection in foods. Trends Food Sci Technol 9(1[91]): 21–27, 1998. 8. AP Lock. Metal detection. Food Proc Ind 49(1):31, 35–36, 1980. 9. A Lock. The Guide to Reducing Metal Contamination in the Food Processing Industry. Tampa, FL: Safeline, 1996.

© 2003 by Marcel Dekker, Inc.

25 Packaging MICHAEL A. MULLEN U.S. Department of Agriculture, Manhattan, Kansas, U.S.A. SHARON V. MOWERY Kansas State University, Manhattan, Kansas, U.S.A.

I.

INTRODUCTION

Today, consumers are faced with a number of challenges from the moment they enter the grocery store. The myriad of packages are designed not only to attract and sell the products we consume, but also to maintain the highest possible quality. Food and beverage packaging is a $70 billion market in the United States and more than $200 billion worldwide [1]. When developing a package for a food product, several factors must be considered. The type of package, rigid or ﬂexible, the ability of the package to maintain food quality, cost and availability of materials, and consumer acceptance are all essential factors. Because of the abundant supply of similar products, attractive packaging that catches the consumers’ eye and ensures them of a high quality product is essential. Excessive packaging can result in needless expense, while cheap packaging can lead to contamination by insects and microorganisms and consequent reduction in the quality of the product. Other concerns must also include tamper resistance and environmental impacts including both the manufacture and the eventual disposal of the packaging materials. Convenience for the consumer is important. It does little good to use a can that is very difﬁcult to open when a simple plastic pouch with a zipper seal will do [2,3,4]. Many consumers have had the unfortunate experience of opening a box of crackers or a bag of ﬂour and discovering a thriving colony of Indianmeal moths, ﬂour beetles, or other insects. Even worse is the feeling one gets while eating a bowl of breakfast cereal and ﬁnding small wriggling insects ﬂoating in the milk. This is the packaging equivalent of ﬁnding half a worm in an apple. © 2003 by Marcel Dekker, Inc.

Although the food processor may take all possible precautions to package an insectfree commodity, the manufacturer may have no control over what is done with the product during shipping and at storage facilities once the product leaves the factory. Food processors and consumers are especially sensitive to these problems and manufacturers are extremely concerned with providing the consumer with high quality products that meet their needs. They know that if the consumer ﬁnds an insect in a cereal package, that unhappy event can make a lasting and often irreversible negative impression, ultimately resulting in the loss of a customer. A pet food manufacturer recently reported $1 million in losses in one year in one product line due to insect infestation. Many companies have implemented package-testing programs to improve insect resistance of packages to insect attack [5]. Insect-resistant packaging is the only way to prevent insect infestation without using insecticides or repellents [6]. Improved packages both reduce direct losses and preserve company image, because consumers usually hold the manufacturer responsible for the insect infestation, regardless of where or how the package became infested [7]. Insect infestation is mainly the result of transportation-related problems or prolonged storage under less-than-optimal conditions in a warehouse or on a grocer’s shelf. Not only are the packaged commodities value-added because they have gone through the expense of growing, harvesting, processing, packaging, storing, and transporting, they also represent goodwill and, ultimately, proﬁts [8]. Since 1990, pet food manufacturers have shown that insect-related losses in their products have declined with the use of insect-resistant packaging. Packages are designed to protect food products from the point of manufacture to the point at which they are ﬁnally consumed. This process often means packages will have to provide protection for up to several years. Unfortunately, there is no perfect package that will provide the protection needed for all products under all conditions. Packages are usually tailored to ﬁt the product being protected. The value of the product, length of time it must be protected, the economics of delivering a high quality product to the consumer, and other factors must be considered when designing and developing insect-resistant packaging. II. HISTORY OF FOOD PACKAGING The earliest accounts of humans utilizing materials to contain food date back to about 10,000 BCE. These containers were usually made from natural materials such as gourds, leaves, shells, and human skulls [9]. Ancient man also used the bladders and skins of animals to contain food. Humans began to use pottery around 6000 BCE. This method of food containment allowed for the shipment of food throughout the then civilized world. By 3000 BCE, glass containers had come into use and the mass production of these was introduced in Rome around 14 CE. The ﬁrst documented use of paper was in the 1500s; paperboard boxes, paper bags, and tinplate cans were developed in the early 1800s. Later forms of packaging included glass, leather bags, wooden barrels, and metals. The onset of the industrial revolution in 1750 led to the development of simple machines that produced mass quantities of food products, resulting in a greater need for packaging. Population movement from rural areas to cities meant that fewer people lived on farms. As individual storage space for food products decreased, foods were stored in © 2003 by Marcel Dekker, Inc.

smaller quantities and it became necessary to purchase foods more frequently. To reduce spoilage it became increasingly important that food products be maintained in a safe, healthy, and sanitary fashion. Tin cans allowed for the preservation of perishable foods; their introduction was an important step in maintaining a reliable food supply. In 1921, aluminum foil showed great potential in the form of the ﬁrst foil-laminated paperboard folding carton. The National Biscuit Company was the ﬁrst to use paperboard for packaging [9]. In France in 1936, rubber hydrochloride (Plioﬁlm) was used to pack perishable foods [9]. By the end of the 1930s, the Simplex bag machine, manufactured by the FMC Corporation, was producing cellophane bags used for the packaging of many foods. Following this lead, plastic packaging materials took hold and were developed throughout the 1970s and 1980s in the form of polyethylene terephthalate (polyester) (PET) bottles, barrier plastic bottles/sheets, and aseptic packages, to name just a few [9]. Plastics and other innovative packaging materials led the way into the 1990s and are still being developed to prevent food spoilage, enhance food storability, and prevent insect infestation.

III. BIOLOGY AND HABITS OF STORED PRODUCT INSECTS Most stored product insect pests are cosmopolitan. They have become established across the world over the years by way of international trade [10]. In their attempts to survive many of the species of stored product insects will infest packaged foods where they have an ample supply of nourishment for their offspring and where they are protected from chemicals that may be used to kill them. Because of distribution practices contaminated products can often be moved from one geographical location to another. In local warehouses and retail stores, infestations can be spread from package to package. While food products can become infested at any point in the marketing channel, they are most likely to become infested during extended storage periods. Some products are more susceptible to insect infestation than others. These products can serve as insect reservoirs, leading to the infestation of other products [7]. Dry pet foods are often the source of infestation. Most pet foods are packed in multiwall paper bags that are generally not very insect resistant because they lack adequate seals and closures. Food may also become infested during shipment in trucks, railcars, and ships, as well as during storage at the retail level. Infestation also occurs in the home pantry, but with the increased use of resealable packages these losses have been reduced. A. How Insects Enter Packages To begin a discussion of insect-resistant packaging, it is important to understand the insect pests that most commonly attack packaged foods. Highland [7,11] separated package pests into two categories, penetrators and invaders (Table 1). Invaders are insects that typically have weakly developed mouthparts at both the larval and adult stages [12]. The invaders account for more than 75% of the infestations encountered [13]. Invaders commonly enter packages through openings resulting from mechanical damage, defective seals, or holes made by other insects penetrating the package [6]. The newly hatched larvae of invaders typically cause the most damage because they are able to ﬁt through holes as small as 0.1 mm wide [12]. © 2003 by Marcel Dekker, Inc.

Table 1 Classiﬁcation of Pests that Commonly Infest Packaged Food Penetrators Red ﬂour beetle, Tribolium castaneum Confused ﬂour beetle, Tribolium confusum Warehouse beetle, Trogoderma variabile Rice weevil, Sitophilus oryzae Almond moth larvae, Cadra cautella Indianmeal moth larvae, Plodia interpunctella Lesser grain borer, Rhyzopertha dominica Cadelle, Tenebroides mauritanicus Drugstore beetle, Stegobium paniceum

Invaders Red ﬂour beetle, T. castaneum Confused ﬂour beetle, T. confusum Merchant grain beetle, Oryzaephilus mercator Sawtoothed grain beetle, O. surinamensis Almond moth larvae, C. cautella Indianmeal moth larvae, P. interpunctella Squarenecked grain beetle, Cathartus quadricollis Flat grain beetle, Cryptolestes pusillus Rice moth larvae, Corcyra cephalonica

Source: Adapted from Ref. 7.

Typical insect penetration into food packaging materials [6,14] is illustrated in Fig. 1. Most infestations are the result of invasion through seams and closures—rarely through penetrations [8]. For example, adult sawtoothed grain beetles have been shown to enter packaging through openings less than 1 mm in diameter; adult red ﬂour beetles can enter holes in packaging that are less than 1.35 mm in diameter [7]. Many insects prefer to lay eggs in tight spaces such as those formed when multiwall paper bags or paperboard cartons are folded to create closures. These refugia provide a safe place to lay eggs and also give the newly hatched larvae an ideal location to invade the packages. 1. Penetrators Insects classiﬁed as penetrators are those that can chew holes directly into packaging materials. Penetrators are more effective in the larval stage; however, some adult beetles can effect penetration [11]. Insects such as the lesser grain borer, Rhyzopertha dominica (Fab.), the cigarette beetle, Lasioderma serricorne (Fab.), the warehouse beetle, Trogoderma variabile Ballion, the rice weevil, Sitophilus oryzae (L.), the cadelle, Tenebroides mauritanicus (L.), and the larvae of the rice moth, Corcyra cephalonica (Stainton), are known to be good package penetrators and are capable of boring through one or more layers of ﬂexible packaging materials. Larvae of the Indianmeal moth, Plodia interpunctella (Hu¨bner), under some conditions are also good penetrators and may be the most serious pests of packaged foods [6,11]. The warehouse beetle is more specialized in the food products it infests and is often found in packages of dry pet food and dry pastas. It may create an additional problem to the consumer because the cast skins of the larvae can cause allergic reactions [15]. The drugstore beetle, Stegobium paniceum (L.), is an able penetrator, infesting a wide variety of foods [16]. 2. Invaders Other species, classiﬁed as invaders, enter packages through existing openings. Some common invaders include the sawtoothed grain beetle, Oryzaephilus surinamensis (L.), the red ﬂour beetle, Tribolium castaneum (Herbst), the confused ﬂour beetle, T. confusum © 2003 by Marcel Dekker, Inc.

Figure 1 Diagrammatic representation of insect penetration into food packaging. F shows scratch marks (made by mandibular action) surrounding a tiny hole through which penetration into the package was achieved. (From Ref. 15.)

Jacquelin du Val, and the ﬂat grain beetle, Cryptolestes pusillus (Schoenherr) [6]. The most important invaders are larvae of the genus Tribolium (ﬂour beetles), the genus Oryzaephilus (grain beetles), and freshly hatched moth larvae [11], especially Indianmeal moth larvae. The classiﬁcations of invaders and penetrators are regularly used to describe packaging pests, but these classiﬁcations are in fact artiﬁcial; some invaders can become penetrators under certain circumstances and vice versa. Although classiﬁed as invaders, larvae of the Indianmeal moth and the almond moth, Cadra cautella (Walker) (also called Ephestia cautella), can penetrate packages given the right conditions [5]. Both penetrators and invaders will exploit package ﬂaws or other existing openings in order to reach a food product, and some invaders can chew directly into weak packaging materials such as paper and cellophane. Considering that insect infestation of stored food products is of such importance to the industry, disproportionately little has been done to describe the behaviors and mechanisms by which insects invade packaged goods. Although it is generally thought invaders enter packages through existing openings, little information is available to support this belief. © 2003 by Marcel Dekker, Inc.

B.

Mechanisms of Entry

Aside from adult stored-product moths, which do not feed, most stored-product insect adults and larvae feed in order to sustain themselves. When faced with consumer food packages, both invaders and penetrators will take advantage of any sort of opening in a packaging material in order to gain entry [17]. These openings may form as a result of the chewing of penetrators, mechanical damage (rips, tears, punctures) resulting from normal wear and tear throughout the handling process, or defective seals in the packaging. C.

Odor Escape Through Openings

Olfaction is the means by which stored-product insects identify packaged consumer food products as a location in which to carry out important life functions such as fulﬁllment of nutritional demands, mate-ﬁnding, and places for oviposition. When an insect ‘‘smells’’ food, it will try to reach it. Barrer and Jay [18] determined that the odor of kibbled wheat, when diffused into a 10-m 3 cage through ten 1-mm diameter holes, strongly attracted gravid, free-ﬂying Cadra cautella (Walker) females that were seeking oviposition sites. When C. cautella females cannot gain direct access to the grain, it is believed they will oviposit in the immediate vicinity of the opening through which the food odor is escaping, possibly to allow some larvae access to the grain upon hatching [18]. Mated female sawtoothed grain beetles have been shown to have a more rapid response to the odor of carob distillate than virgin females. It has been speculated that the more rapid response of these female beetles to food odor is somehow related to the process of egg production [19]. The age of an insect has an effect on response to food odor. White [19] determined that 2-day-old adult sawtoothed grain beetles showed a signiﬁcant preference for the odor of carob distillate; the response increased with age up to 16–20 days. However, Honda et al. [20] showed that newly emerged adult Sitophilus zeamais less than 10 days old are more sensitive to attractants from rice than are older weevils. IV. PACKAGE TYPES A.

Package Design

Most nonperishable food items are shipped in consumer-sized packages and most of these, with the exception of canned food, are susceptible to insect attack [21]. Seals and closures can often be improved by changing glue patterns or the type of glue used. Generally, a glue pattern that forms a complete seal with no channels for the insect to crawl through is the most insect resistant. Sharp folds and buckles should be avoided because they weaken the material and provide easier access by pest insects [12]. Insect resistance can also be improved by overwrapping the packages with materials such as oriented polypropylene ﬁlms [5]. For maximal effectiveness, overwraps should ﬁt tightly around the package. If overwraps are not completely sealed, insects often can gain entry at the corners of folded ﬂaps. However, if the overwrap is sealed tightly, the movement of insects will be restricted, thus reducing the chances of infestation. Since it is impossible to prevent all vulnerable spots, it is important to be alert to the problems incomplete seals can cause. Another means of discouraging insect infestation is through the use of odor barriers [21]. Food odors may be prevented from escaping the package through the use of barrier © 2003 by Marcel Dekker, Inc.

materials, resulting in a package that is ‘‘invisible’’ to invading insects. Flexible packaging, incorporating acrylic, polyvinylidene chloride (PVdC), or ethylene vinyl alcohol (EVOH), can improve odor retention [9]. These materials have been used with some success. However, any ﬂaw in the package will negate the odor-proof qualities of the package [6]. Mullen [8] showed that when odor barriers were used to protect a commodity, only those packages with ﬂaws became infested. B. Packaging Materials Food products are packaged in a wide variety of paper and plastic materials. New materials, constantly being added to the list, are far too numerous to discuss in detail in this forum. Paper is still one of the most widely used products and is certainly one of the most easily penetrated materials. Paper is often used with foil and polyethylene to form multiwall packages. This type of packaging, often found in pet food bags, provides excellent strength, serves as a moisture barrier, and can be grease proof. It provides little protection from insect penetration because of the difﬁculty in making an adequate seal. Bags with a heat sealable inner layer can be sealed, but the outer plies must be folded and glued. The sealed end ﬂaps of these packages provide insects with dark, protected areas in which eggs can be deposited. Newly hatched larvae seldom have trouble entering the package through existing openings in commercially sealed packages—80% of such packages have leaks. Odors escaping through these minute openings attract pests to the vicinity of the perforations. These holes are often sufﬁciently large in diameter to permit entry of the ﬁrst instar larvae of most stored-product insects. A well-sealed, airtight package can create additional problems. Changes in air pressure or temperature can cause swelling or shrinking of the package [12]. One technique to prevent this is to build in small ventilation holes that allow the pressure to equalize. Invading insects can access the package through these minute holes. This problem can be avoided by creating a torturous path for the insects to follow. One of the simplest ways to accomplish this is to build in a double heat seal with vents at opposite ends of each seal. This method has been shown to allow for pressure equalization while limiting insect invasion. Cellophane is one of the oldest plastic ﬁlms to be commercialized. The desirable physical characteristics of cellophane include transparency, clarity, and heat sealability. Many of these attributes were lacking until nitrocellulose was developed in 1927 [9]. Studies on cellophane-wrapped packages conducted at the U.S. Grain Marketing and Product Research Center (GMPRC) have shown that both dry cat food and raisins packaged in cellophane were very susceptible to penetration by a variety of stored-product insects including the Indianmeal moth, the warehouse beetle, and the cigarette beetle. Paper and cellophane are probably the least resistant to insect penetration of all the ﬂexible packaging materials in use today. Depending on environmental conditions, some insect species can penetrate kraft paper in less than 1 day [11]. Adding multiply construction adds little to the resistance. Polyester (PET), ﬁrst developed in 1941, has good resistance to insect penetration, but its use in packaging has been limited because of high cost, less coverage per pound of material, and limited shrink properties [22,23]. In recent years there has been a dramatic increase in the use of PET and metalized PET in ﬂexible packaging. Polyvinylidene chloride is a good odor barrier, but used alone can be breached by invading insects. However, laminates containing PET and PVdC provide very good protection against insect penetra© 2003 by Marcel Dekker, Inc.

tion when the PET side is exposed to insects [24]. These materials are commonly used to protect refrigerated or frozen food. The tough, 10-mil polyethylene wrapper around meals ready to eat (MREs), a packaged food dispensed to military personnel, is generally resistant to penetration. However, under extremely crowded conditions, T. castaneum adults have been known to penetrate these packages. Even laminates can be susceptible to insect attack. Plastic has several advantages over paper for packaging. For example, it can ensure to a much greater extent than paper that the contained materials will remain in their original condition. Plastic packages can be colorful, attractive, and made into different sizes and shapes. Work done at the GMPRC has shown that many plastic materials resist infestation by most stored-product pests. The materials available include low density polyethylene (LDPE), ethylene vinyl acetate (EVA), high density polyethylene (HDPE), linear low density polyethylene (LLDP), ultra low density polyethylene (ULDPE), ethylene acrylic acid copolymers (EAAC), polyoleﬁn plastomers (PP), and enhanced polyethylene resins (EPER) [2–4]. Each has unique characteristics and uses. Because of its high clarity and ability to be extruded, LDPE is used as a coating for paper/paperboard and bread bags and in applications where strength is not essential. Similar to LDPE, EVA is used in applications such as ice bags and wrappings for fresh produce, cereal, cheese, and crackers. Being both an excellent barrier to moisture and stiffer than other PEs, HDPE works well as bags for cereals, crackers, cake mixes, and dry foods. It can also be used for thermoformed trays and blow-molded applications such as milk jugs. Linear low density polyethylene is often used as a frozen food ﬁlm and in bag-inbox applications; ULDPE has excellent tear and puncture resistance and is often used in poultry packaging, bag-in-box applications and fresh cut produce. Ethylene acrylic acid copolymers adhere well to other substrates like foil, nylon, and polyethylene. It is often used as packaging for snack foods and processed luncheon meats. With its excellent sealing properties and toughness, PP is used for fresh cut produce, cheese, meats, and cereals. Enhanced polyethylene resins [3,4] is similar to polyethylene, but has high stiffness and good impact strength. It is used as a freezer ﬁlm, bag-in-box, cook-in meat packaging, and for cereals and crackers. Recently, stand-up plastic pouches have become popular and have been shown to be very resistant to insect penetration. Studies by Cline and Highland [25] showed that insect survival in airtight plastic pouches was reduced and that no insects survived in unpenetrated packages after 12 weeks.

V.

PROTOCOL FOR DETERMINING INSECT-RESISTANT PACKAGING

Studies of noninsecticidal methods of insect-prooﬁng packages, conducted at the GMPRC, were designed to maximize infestation pressure. These simple procedures have been highly effective in developing and improving packaging methods for better insect resistance. In a typical test, different types of commercially prepared packages are exposed to ﬁve species of insects consisting of the red ﬂour beetle, the sawtoothed grain beetle, the Indianmeal moth, the cigarette beetle, and the warehouse beetle. These species represent a good © 2003 by Marcel Dekker, Inc.

cross-section of both penetrators and invaders and are representative of the most common insect pests associated with packaged foods. The packages are placed in an environmentally controlled (27 ⫾ 2°C, 50 ⫾ 5% RH) chamber measuring 3 ⫻ 9 ⫻ 2.5 m (40 m 3 ) in size. Approximately 1000 specimens of each of four kinds of beetles (red ﬂour beetle, cigarette beetle, sawtoothed grain beetle, and warehouse beetle) and 300 adult Indianmeal moths are added to each test chamber. Eight to ten individual packages of each type are used for each sample period (breakdown). Breakdowns are made biweekly or monthly depending on the commodity and its potential for infestation. Tests are run for approximately 3 months. This is generally the maximal amount of time most packages will resist the infestation pressure by these large numbers of insects. At the end of each exposure period, the packages are carefully checked for obvious signs of infestation, which are recorded if present. Signs include penetration holes (entry or exit) and obvious ﬂaws in the seams and closures. After the packages have been externally examined, they are opened and the commodity inside the package is examined for insect infestation. Insects of each species are identiﬁed, counted, and the numbers recorded. After each test, a report is prepared and suggestions are made to improve the packages. Manufacturers use this information to improve the performance of future package designs. Packaging studies have been conducted on a variety of commodities in cooperation with a number of food manufacturers. Dry pet foods, breakfast cereals, baby foods, rice products, military rations, and raisins are some of the products that have been included in these package-improvement studies. The results are generally positive; one company reported a 40% reduction in complaints due to insect-related problems.

VI. REPELLENT TREATMENTS Repellents, as the word implies, have the characteristic of repelling insect entry or movement across a treated surface. The technique of using of repellent coatings on packages to prevent insect infestation is in need of much more research. In 1978, Highland [23] listed the development of repellent treatments as a priority topic needing additional research. Through the years, many repellent formulations have been tried but with little if any success. Studies conducted by the senior author included natural and synthetic compounds such as Neem oil, methyl salicylate, DEET derivatives, and insect growth regulators. Many of these compounds were effective in laboratory choice tests. However, food odors from the packages either greatly reduced or completely eliminated the effectiveness of the repellent treatment. Another problem is the migration of the repellent compound through the packaging material. Recently, methyl salicylate received approval by both the Environmental Protection Agency and Food and Drug Administration as a package treatment. This is especially signiﬁcant because it represents the ﬁrst such approval and should make it easier for other materials to be approved.

VII. SUMMARY The pursuit of new developments in insect-resistant packaging is becoming increasingly important to both consumers and manufacturers for two reasons: (1) demanding production schedules sometimes outpace the sanitation chores needed to protect the processing plant © 2003 by Marcel Dekker, Inc.

from insect infestation and (2) more stringent restrictions on pesticide use in food processing facilities makes successful pest management more problematic. When food products are packaged using insect-resistant techniques, the consumer is assured of insect-free food and the manufacturer is protected against both lawsuits arising from insect infestations in consumer-sized packaging and loss of consumer good will. Future research in this area will lead to the development of more effective packaging methods to ensure that packaged foods remain insect free until consumed. REFERENCES 1. SL Wilkinson. In defense of food. Chem Eng News 76(24):26–32, 1998. 2. LK Kindle. Packaging . . . bending to meet a changing society. Food Processing 61(1):63– 65, 2001. 3. JH Briston, LL Katan. Plastics Films. London: J. H. Briston and the Plastics and Rubber Institute, 1983. 4. RC Grifﬁn, S Sacharow. Principles of Package Development. Westport, CT: AVI Publishing, 1972. 5. MA Mullen, SV Mowery. Insect-resistant packaging. Int Food Hygiene 11(6):13–14, 2000. 6. MA Mullen, HA Highland. Package defects and their effect on insect infestation of instant dry non-fat milk. J Packaging Technol 2:266–267, 1988. 7. HA Highland. Insect infestation of packages. In: FJ Baur, ed. Insect Management for Food Storage and Processing. St. Paul, MN: American Association of Cereal Chemists, 1984, pp 309–320. 8. MA Mullen. Keeping bugs at bay. Feed Management 48(3):29–33, 1997. 9. S Sacharow, AL Brody. Packaging: An Introduction. Duluth, MN: Harcourt Brace Jovanovich, 1987. 10. HA Highland. Chemical treatments and construction features used for insect resistance. Package Devel Syst 7(3):36–38, 1977. 11. R Wohlgemuth. Protection of stored foodstuffs against insect infestation by packaging. Chem Ind 10:330–334, 1979. 12. LD Collins. How food packaging affects insect invasion. Pest Control 31(10):26–29, 1963. 13. PM Brickey Jr, JS Gecan, A Rothschild. Method for determining direction of insect boring through food packaging materials. J Assoc Off Anal Chem 56(3):640–642, 1973. 14. HA Highland. Protecting packages against insects. In: JR Gorham, ed. Ecology and Management of Food-Industry Pests. Arlington, VA: Association of Ofﬁcial Analytical Chemists, 1991, pp 345–350. 15. AR Olsen, JS Gecan, GC Ziobro, JR Bryce. Regulatory action criteria for ﬁlth and other extraneous materials. V. Strategy for evaluating hazardous and nonhazardous ﬁlth. Reg Toxicol Pharmacol 33:363–392, 2001. 16. DK Mueller. Stored Product Protection—A Period of Transition. Indianapolis: Insects Limited, 1998, pp 207–212. 17. LD Cline, HA Highland. Minimum size of holes allowing passage of adults of stored-product Coleoptera. J Georgia Entomol Soc 16(4):525–531, 1981. 18. PM Barrer, EG Jay. Laboratory observations on the ability of Ephestia cautella (Walker) (Lepidoptera: Physitidae) to locate and to oviposit in response to a source of grain odour. J Stored Products Res 16:1–7, 1980. 19. PR White. Factors affecting the antennal and behavioural responses of the sawtoothed grain beetle, Oryzaephilus surinamensis, to food odour and aggregation pheromone. Physiol Entomol 14:349–359, 1989. 20. HL Honda, I Yamamoto, R Yamamoto. Attractant for rice weevil, Sitophilus zeamais (Coleop-

© 2003 by Marcel Dekker, Inc.

21. 22. 23. 24. 25.

tera: Rhynchophoridae), from rice grains. I. Bioassay method for the attractancy of rice grains to rice weevils. Appl Entomol Zool 4:23–31, 1969. MA Mullen. Rapid determination of the effectiveness of insect resistant packaging. J Stored Products Res 30:95–97, 1994. S Sacharow, RC Grifﬁn Jr. Basic Guide to Plastics in Packaging. Boston: Cahner Books, 1973. HA Highland. Insect resistance of food packaging—a review. J Food Processing Preservation 2:123–130, 1978. KM Rao, SA Jacob, MS Mohan. Resistance of ﬂexible packaging materials to some important pests of stored products. Indian J Entomol 34(2):94–101, 1972. LD Cline, HA Highland. Survival of four species of stored-product insects in airtight laminated food pouches. J Econom Entomol 71(1):66–68.

© 2003 by Marcel Dekker, Inc.

26 Beverage Plant Sanitation and HACCP HENRY C. CARSBERG Henry C. Carsberg & Associates, Anacortes, Washington, U.S.A.

I.

INTRODUCTION

Sanitation is a vital ingredient in the area of food safety [1]. Some have viewed a sanitation program as a ‘‘necessary evil’’ when in reality a successful sanitation program is the number one reason for product success. Whenever a processor takes a chance (and at the same time likely violates the Federal Food, Drug, and Cosmetic Act) and allows a product to be packed or processed under unsanitary conditions, product degradation may be expected. Good sanitation starts at the top, with upper management’s attitude about sanitation—its value and importance to the product they intend to produce. It is never easy to explain the cost of a large recall or the enormous legal costs and bad publicity that comes with a recall. If a processor is lacking the expertise to develop a professional sanitation program, management should consider having a knowledgeable consultant come in to devise a program that meets the processor’s speciﬁc needs. There are so many things to consider—from the clean-in-place (CIP) system to restrooms, ﬂoors, drains, outside areas, and pest elimination—that nothing short of a detailed and fully implemented sanitation program will meet the need. Proper training of personnel is of critical importance, untrained personnel can cause even the best program to fail. Personnel need to be trained in all aspects of food safety and sanitation, utilizing both workshops and ongoing on-the-job training. All employees must develop proper work and personal habits while working in a beverage environment. Good housekeeping is of major importance to reduce pests and to help prevent any possibility of foreign material entering the product. © 2003 by Marcel Dekker, Inc.

Nothing can be left to chance. Every new hire must be made aware of the Food and Drug Administration (FDA) good manufacturing practices (GMPs). The GMPs are the basic rules of the processing environment, rules that personnel must follow and rules that management must follow up on. Management should institute an ongoing program to review the GMPs. II. BASIC CLEANING SEQUENCE This basic cleaning sequence is used for everything other than the CIP system. A.

Prerinse

Prerinse all equipment and areas. Work from the top of equipment down to the ﬂoor. This will remove the larger, less ﬁrmly attached particles and some of the bacteria. B.

Apply Cleaning Product

The next step is to apply cleaning product. The cleaning agent used should be based upon The The The The The The The The The C.

type of soil (residues from food manufacturing processes) surface to be cleaned degree of agitation required environment—where the waste products are going temperature at which the product was processed time allowed for sanitation use cost of the product concentration of the cleaning chemical method used for applying and removing the cleaning product

Hand Detail and Inspect

There are no short cuts in a sanitation system. Some hand detailing will be required. There are no magic formulas that can eliminate organic challenge without some handwork. Also, while hand detailing, personnel are better able to inspect the surfaces to be sure they are clean. D.

Postrinse

Postrinse comes next. This step is of utmost importance because the cleaning chemicals, the organic challenge (the ingredient residues, called soils, that stick to food-contact surfaces must be cleaned off ), and some bacteria are all being removed. Since sanitizers range in pH from 3.2 to 7, any high-pH cleaning product (with a pH of 12 to 13, for example) unless totally rinsed away will diminish the efﬁcacy of the sanitizer. In short, a high pH cleaner brings up the low pH of the sanitizer, causing it to lose its effectiveness. If the cleaning agent is not thoroughly washed away, the result may be a poor kill rate of bacteria and mold. E.

Apply Sanitizer

The next steep is the application of the sanitizer. Sanitizers can be quaternary compounds with or without acid, acid-anionic sanitizers, iodophors, chlorine, chlorine dioxide, para© 2003 by Marcel Dekker, Inc.

cetic acid, and others. When using one of the quaternary sanitizers, it is recommended that you alternate it with an oxidizer type of sanitizer such as an iodophor or an acidanionic sanitizer to prevent the bacteria from becoming resistant to the quaternary product. One important fact to remember is that all sanitizers are classiﬁed as pesticides and must be approved by the Environmental Protection Agency (EPA). Therefore, all sanitizers must be used in conformance to the label directions.

III. SOFT DRINKS AND BEER Soft drinks and beer are on the acidic side of the pH scale. While pathogenic microorganisms do not pose a major food safety problem in this industry, they can cause quality problems by producing off-color and off-tastes. Soft drinks, with their phosphoric acid content, and beer, with its low pH, are among the safest beverages to consume. From the standpoint of taste and eye appeal, there are microorganisms that can cause an off-taste or turbidity. The undesirable taste can range from sour to oversweet to a sulfur type ﬂavor. The primary sanitation concerns for beer and soft drinks focus on the following factors. A. Water Supply Water supply is critical due to the possibility of contamination by foreign materials such as silt, sand, or clay if the source is from a well. There are many types of ﬁltration systems that may be employed to prevent soil residues from entering the system in the event that a well is used as the water source. Sometimes even municipal water treatment plants inadvertently propel sand particles into the distribution system, thus water being supplied by a modern treatment plant does not necessarily guarantee freedom from unwanted foreign matter. Other water supply considerations include the mineral content of the water, the impact of chlorinated water on taste or color, and the potential for contamination by pathogenic bacterial and parasites. Nothing regarding water supply should be taken for granted. Water is, after all, the main ingredient of soft drinks and beer. B. Containers Cans, bottles, jugs, and other containers can also be a source of contamination by the presence of foreign objects such as wood, metal shavings, and other materials. Product containers (i.e., empty containers being fed into the ﬁller line) must be checked according to a standard sampling plan. Single-use containers are rinsed with water immediately before being reﬁlled with product, this additional preventive measure provides the consumer with an extra measure of protection. In the case of returnable containers such as bottles and kegs, the cleaning agents used to prepare these containers for reuse must be thoroughly rinsed away and the efﬁcacy of the cleaning and rinsing procedures should be checked by standard analytical methods. C. Bottle Filler Bottling equipment can cause glass bottles to break, thus creating a potentially serious hazard. Broken glass sometimes falls into product containers when the bottles get stuck © 2003 by Marcel Dekker, Inc.

on approach to the ﬁller but the conveyor keeps on moving, smashing the bottles against each other. D.

Ingredients and Raw Materials

Raw ingredients must be inspected for foreign matter and analyzed according to standard sampling and analytical procedures. In the case of facilities that process grain, a rodent and insect prevention and elimination program should be in force. Since ingredients can come from so many different sources, letters of compliance from suppliers stating that they process under a hazard analysis critical control point (HACCP) system, as well as audits of suppliers’ facilities, may well be reasonably required by processors. The fact that there have been many instances of foreign objects and microbial contamination having been found in both raw ingredients and in ﬁnished product is testimony to the need for constant vigilance by quality control and sanitation personnel, indeed by all employees. IV. JUICE Juices are in a category by themselves. In those instances (becoming less common as time passes) where juice is marketed without pasteurization, the danger from foodborne pathogen is much greater than in the case of pasteurized juices. In the case of unpasteurized juice, the fruit must be washed with a cleaning agent of neutral or near neutral pH and then rinsed thoroughly to eliminate any dirt and bacteria from the skin prior to crushing. The kinds of sanitation procedures used in wine making are also applicable to the pressing of fruit juice (see Section VI). For sanitizing the skin of the fruit, chlorine dioxide can be used. Chlorine dioxide, used in a low (parts per million) concentration, will eliminate 99% of the surface bacteria. It is also effective if dirt or organic challenge is involved. Hazards can become especially serious when fruit is picked up from the ground and then squeezed or crushed into juice. Escherichia coli, Salmonella spp, Listeria monocytogenes, and other pathogens that occur in the earth underneath fruit trees often contaminate the skin of apples or other fruits. If the fruits are not washed, rinsed, and sanitized, these pathogens become incorporated into the product. Even when the juice is subsequently pasteurized, some bacteria such as certain spore-forming bacilli are able to survive and may eventually cause problems for the consumer. V.

BREWERY SANITATION

The low pH of beer restricts pathogen activity and imposes limitations on an array of spoilage microbes. Bacteria of greatest signiﬁcance in this environment are non–spore formers [2]. Spore-forming bacteria such as Clostridium spp. may be involved in the spoilage of brewery by-products such as spent grain. The non–spore-forming bacteria found in breweries may contribute to a wide variety of problems in the wort (unfermented infusion of malt), including pH elevation, acidiﬁcation, acetiﬁcation, subsequent incomplete fermentation, and ropiness [3]. Microbial contamination of this sort may also be directly or indirectly responsible for various off-odors and biological hazes in ﬁnished beer [2]. In order to control these kinds of bacterial contamination, a complete sanitation © 2003 by Marcel Dekker, Inc.

program is required, one that also includes such environmental factors as the HVAC system and the immediate environs of the processing plant. Preventing contamination is at least as important as cleaning up contaminated surfaces and raw materials. Heat pasteurization, a very common method of preventing microbial contamination, is used not just in the beverage industry, but also with milk and other dairy products. When using a heat pasteurization method, time and temperature charts must be kept and retained on ﬁle, and the pasteurizer must be checked and tested on a regular timetable. The pasteurizer and the associated piping are cleaned using a CIP system. A. Cold Pasteurization The application of sanitizing chemicals could be termed ‘‘cold pasteurization.’’ The inventory of sanitizing agents often changes as new products and new formulations are developed by the manufacturers. The safety and efﬁcacy of each new product or new formulation is subject to review by EPA. The bacterial count of pitching yeast (yeast added to wort) may be reduced by treatment with diluted acids such as phosphoric, sulfuric, and tartaric. However, these acid treatments, while effectively reducing unwanted bacterial ﬂora, may adversely affect the yeast cultures to such an extent that retarded fermentations occur in the ﬁrst few cycles after treatment. B. Beer Pasteurization The majority of brewers utilize pasteurization to achieve a stable product, especially with respect to ﬂavor and smoothness. Overheating during pasteurization, however, can have an adverse effect on ﬂavor and can cause haze. It is essential to strictly adhere to the precise time and temperature parameters for effective microbial destruction [3]. Some breweries have adopted sterile ﬁltration as a substitute for pasteurization. To reduce the risk of the bacteria breaching the ﬁlter barriers, the ﬁlters should be replaced every 2 weeks. Ceiling mounted cooling units are commonly used to cool the product. Suspended under each cooling unit is a pan that catches condensate and conveys it to a ﬂoor drain. These pans must be cleaned on a scheduled basis in order to prevent the proliferation of Legionella and other dangerous or deleterious microbes in the condensate. These microbes are subject to being transported on air currents to all areas of the plant. A regular cleaning and sanitizing cycle must be put into force. One preventive measure that can be taken is to place iodine tablets (West Argo, Kansas City, MO) in the drip pan to suppress bacteria growth. VI. WINE PRODUCTION To produce a quality product, it is essential to remove all the soils that affect the taste, appearance, and shelf-life of wine. The reddish tartrate deposits that accumulate on tank interiors as a result of fermentation are among the more common kinds of soils. These and other tenacious soils must be cleaned from the surfaces of the processing equipment throughout the winery in order to suppress unwanted microbial growth [2]. One important and sometimes overlooked item to keep in mind is that farm implements and other tools used in the maintenance of the winery must be kept separate and far removed from the crusher and other wine-making equipment. © 2003 by Marcel Dekker, Inc.

The water used in a winery must have speciﬁc chemical and microbial properties [3]. A low pH is inimical to steel and other surfaces, and a high pH favors calcium precipitation. The biological oxygen demand (BOD) should be less than 3 mg/L. Since water can be a potential carrier of molds, yeasts, and acetic or lactic acid bacteria, only water that is free of these and other contaminants should be used [2]. All areas of the winery must be cleaned, this includes but is not limited to the bottling area; barrels; tanks; cooperage; all equipment including destemers, crushers, and conveyors; and ﬂoors, walls, and ceilings. Wine is very susceptible to contamination by and deterioration due to spoilage bacteria [4]. Even though wine is on the lower end of the pH scale, some kinds of bacteria are still capable of deleteriously affecting the beverage. A.

Pomace Disposal

It is essential to dispose of the pomace as rapidly as possible after pressing. It must not be allowed to stand in or near the fermentation room since it rapidly acetiﬁes. Fruit ﬂies (Drosophilidae) breeding in the pomace may then carry acetic acid bacteria to clean fermenting vats. Pomace should either be further processed (to render it innocuous) or scattered as a thin layer on ﬁelds where it dries quickly and does not become a suitable breeding medium for fruit ﬂies [2]. VII. PEST MANAGEMENT Rodents and ﬂies and other insects must be controlled in order to prevent microbial contamination, spoilage, and foodborne diseases. The most effective strategy for pest control is to retain a qualiﬁed pest management professional (PMP). In order to effectively back up and support the PMP’s advice, the sanitation staff must become very familiar with the various methods available for pest control. A licensed professional, along with a trained staff, can be very effective against pests in the processing environment. VIII. SANITATION EQUIPMENT The selection of appropriate sanitation equipment and its proper use are prerequisites to a thorough and economical method of cleaning and sanitizing. With good equipment and trained personnel on hand, accurate dilution rates of chemical products can be achieved and labor costs can be reduced. Given here are some examples of sanitation equipment. A.

Foam Tanks

A foam tank is like a giant aerosol can. The system is powered by compressed air. The tank, fashioned of stainless steel, is ﬁlled with water, the appropriate chemical added, the lid secured, and the air hose connected. When the application wand is set to the ‘‘on’’ position, the cleaning agent is released as a foam. Sanitizers in foam formulation tend to cling longer to the target surfaces, thus prolonging the cleaning action, than do simple water-based formulations that quickly run off the target surfaces. (Lafferty Equip., Little Rock, AR.) B.

Central Foam System

In this centralized arrangement, the foam and sanitizer units are attached to a wall or to a building support column. The chemicals and pumps are located in a separate room, © 2003 by Marcel Dekker, Inc.

locked for security. From this central location, the cleaning and sanitizing products are pumped to the various stations throughout the plant. Under this system, the operator can precisely control the dilution rates of the cleaners and sanitizers. In these cases where a centralized system cannot be used, independent foam-sanitizer stations can be set up and provided with the necessary air and water connections. When it is time for the cleaning cycle to begin, operators ﬁll the individual stations with the diluted chemicals brought out from a central mixing area. (Lafferty Equip., Little Rock, AR.) C. Hose End Foamers Hose end foamers, driven by water pressure from a hose, can be employed effectively. The correct dilution of the concentrated cleaner/sanitizer is effected as the water passes through the hose end attachment. D. High-Pressure Systems The high-pressure system generates 800 to 2300 psi to propel cleaners/sanitizers against the surface to be cleaned. Care is advised when using high pressure because the force of the impacting liquid can dislodge microbes and soils and propel them to distant areas of the processing plant, sometimes contaminating surfaces that must be kept clean in order to produce a quality product. E.

Water

The temperature of the water-cleaning chemical mix should not exceed the range of 123 to 130°F. Water at temperatures higher than recommended will cook product residues (soils), causing them to stick to equipment surfaces and promote the formation of bioﬁlms. The heat causes microscopic pores in the metal to expand, allowing proteins and other food components to enter into the pores and then become trapped when the pores later contract upon cooling. By carefully selecting cleaning equipment and cleaning chemicals from the wide selection of equipment and materials available from industrial suppliers, plant management, in consultation with sanitarian advisors, can implement a cleaning/sanitizing program that is both economical and effective. IX. THE HACCP SYSTEM The HACCP system, developed by NASA and the U.S. Army Natick Soldier Center in the 1960s, was used by the Pillsbury Company to minimize hazards from potential microbial contaminants in the production of food to be consumed by astronauts in the space program. The HACCP system is useless unless all members of management, quality control, production, sanitation, and other personnel in the plant buy into the design and implementation of the program. The HACCP team usually consists of one member each from management, sales, production, sanitation, and quality control. The HACCP program consists of the following steps: 1. 2. 3. 4.

Formulate an organizational chart and a narrative of the company. Write a description of the products. Outline the methods of distribution and storage. Identify the intended use and the consumer.

© 2003 by Marcel Dekker, Inc.

5. 6. 7. 8.

Develop a ﬂow diagram. Set up the hazard analysis worksheets. Identify all potential hazards. Identify the potential process hazards. Hazards are grouped as chemical, such as cleaning compounds; biological, such as microorganisms; or mechanical, such as wood, glass, and metal.

Once the HACCP ﬂow diagrams and worksheets are complete, critical limits are then determined, and a method for monitoring each critical control point is put in place. Temperature monitoring forms, incoming ingredient forms, and all other required forms are designed and put in place. The HACCP plan can be very detailed or it can be very simple, perhaps having only one critical control point (CCP). The key is not to see how many CCPs can be found, but rather which CCPs really affect food safety. In some instances, due to in-house time constraints and lack of expertise, a consultant can be brought on board to design the HACCP program and the standard sanitary operating procedures (SSOPs), and then draw up an integrated plan that ties together all the disparate aspects of the plant sanitation program. X.

SUMMARY

Most soils found in beverage plants are high in sugar content, are water soluble, and are relatively easy to remove. Unwanted microorganisms may be difﬁcult to remove from the processing environment, but failure to do so may well come to be expressed in diminished product acceptability. Rigid control over the quality of raw materials is an esential ﬁrst step toward ensuring that these ingredients going into the processing stream are free of contamination. It is important, too, that all employees receive instruction about proper storage practices so that pest harborages are not created and proper cleaning proceeds unimpeded. Designing and carefully implementing a proper sanitation program will save money and will increase product quality. By carefully determining the soil load, the surfaces to be cleaned, the temperatures of the various manufacturing and cleaning processes at each stage in the production stream; by minimizing the environmental impacts of food processing and cleaning/sanitizing wastes; by careful selection of cleaning products with due regard for effectiveness, costs, and environmental impacts; by giving as much attention as needed to hand detailing; by proper execution of both prerinse and postrinse; and by acquiring and maintaining the suitable manufacturing and cleaning equipment, the production of a quality product will be largely ensured. Above all, adequate training of plant personnel will greatly enhance product quality, will promote safety for both employees and consumers, and will go a long way toward ensuring that the company remains on a sound economic basis. REFERENCES 1. JG Brennan, JR Butters, ND Cowell, AEV Lilley. Food Engineering Operations, 3rd Ed. London: Elsevier Applied Science, 1990, pp 497–522. 2. JS Hough, DE Briggs, R Stevens, TW Young. Malting and Brewery Science. Hopped Wort and Beer. London. Chapman and Hall, 1971. 3. NG Marriott. Principles of Food Sanitation, 4th Ed. London: Chapman and Hall, 1999. 4. JM Jay. Modern Food Microbiology, 6th Ed. New York: Aspen Publishers, 2000.

© 2003 by Marcel Dekker, Inc.

27 Cereal Food Plant Sanitation GREGORY A. UMLAND, A. JAY JOHNSON, and CHERYL SANTUCCI Ringger Foods, Inc., Gridley, Illinois, U.S.A.

I.

CLEANING CEREAL FOOD PLANTS

As is true with any cleaning project, the old adage holds: an ounce of prevention is worth a pound of cure. Before setting up any cleaning schedule or program it would be wise to invest in an edition of Engineering for Food Safety and Sanitation: A Guide to the Sanitary Design of Food Plants and Food Plant Equipment [1] to see what can be done to avoid unnecessary labor costs. Unfortunately, where cereal plants are found, grain dust will also be found. The accumulation of grain dust is not only unsighly, but also provides food for unwanted pests. By not avoiding or continually removing this food source, the plant is putting the company’s business in jeopardy. This chapter breaks down the subject of cleaning into ﬁve separate categories and discusses each one individually. These areas are (1) receiving area, (2) mixing area, (3) processing area, (4) packaging area, and (5) ﬁnished goods warehouse. Please keep in mind that each plant and process is peculiar in its own right. Suggestions may not ﬁt every process or plant but are intended to cover basic situations. A. Incoming Warehouse and Receiving The ﬁrst step again is prevention. No product should enter that is not ﬁrst carefully inspected. Any outdated, opened, or damaged ingredients should be refused. Careful care should also be given to the condition of the trailer. Holes or damage incurred that could allow the entrance of pests should be noted and that trailer should be refused. The usual 18- to 24-in. borders around the perimeter walls should be painted white, maintained free of product, and kept clean. The clean white color helps the warehouseman to remember not to push product up against the walls and allows for easy inspection and observation of any dead insects or pest activity. The ﬂoor should be swept on a daily or as needed © 2003 by Marcel Dekker, Inc.

Figure 1

Forklifts can damage bags. All dust should be swept off the ﬂoor.

basis. If any bags are broken, they should be removed and destroyed immediately (Fig. 1); all dust and residual material should be swept up off the ﬂoor and adjacent material. Blowing the bags clean with compressed air will only move the dust to another location; use a vacuum instead. A lift should be used to remove any cobwebs on the ceiling area according to the cleaning schedule (the author recommends at least monthly). All bagged ﬂour should be rotated or purchased so it is held no longer than a month if at all possible. If ﬂour or even other ingredients are over a month old they should be inspected at least weekly. Bulk ﬂours should be inspected for insects and foreign matter on a load by load basis. If possible, an Entoleter should be used to destroy any larvae in the ﬂour before it enters the plant. B.

Mixing Area

Anywhere ﬂour is moved or mixed there will be dust. The importance of good dust collection cannot be overemphasized in this area (Fig. 2). Any equipment located in the mixing area should be of sanitary design with easy access for cleaning. Augers should have bottoms that do drop out; mixer lids should be removable; microsystems and other bins should have clean-out doors; etc. The preferred method for cleaning is to stay dry. When water is introduced to a dry system, bacteria can start growing where water does not dry or all material is not removed from cracks and crevices. Microbial life is not unlike any other life form; without water it will not ﬂourish. Most employees prefer holding a hose to operating a vacuum, using a brush, or sweeping, so it is important to keep air and water hoses out of those areas or they will be used more than they should. Clean, food-grade, color-coded brushes used only for cleaning purposes should be used. It is recommended to keep them where they will be used, up and off the ﬂoor. These should be sanitized and inspected on a frequent basis. The mix-room can be where they are kept. Vacuums are preferred. It is best to have permanent vacuum hoses from a central vacuum system located where they are easily accessible. Portable vacuums are also allowed, but care must be taken to keep the ﬁlters and bags or bins clean. Attachments should also be color coded. One color should be used for the ﬂoor and another should be used for food contact areas. Periodically water can be used in cleaning a dry system, but it is essential that it is done © 2003 by Marcel Dekker, Inc.

Figure 2 Dust collection systems are essential anywhere dust may be created by ﬂour.

meticulously and that ample time is given for drying before the system is put back in use. Remember that the dust that lies around in the mix room or any area of a cereal plant is food for insects. Depending on the design of the system, on the ingredients, on management’s philosophy, etc., cleaning may be performed hourly, per shift, per day, or per week. C. Processing Area There are many different processes for producing cereal, which are described in Breakfast Cereals and How They Are Made [2]. Since the author is familiar with that of extrusion we will cover that area in more detail. Typically a ﬂour mixture is conveyed to the extruder bin via air conveyance or other means. As mentioned, when ﬂour is moved dust is created. Once again, it is important to have good dust collection in this area. Additionally, cooked or processed cereal can also create dust and ﬁnes. This is especially true with the large amounts of air that are passed through or over the cereal to dry it. Doors on ovens and coolers, etc., must be well sealed (Fig. 3), and care should be taken to prevent or collect dust in these areas also. Due to the nature of the process and the excess amount of waste that is created by starting and stopping this type of equipment, most plants run continuously for 5 to 7 days per week. This makes it impossible to clean inside the extruder frequently, so it must be done during product changeovers. Typically water can be used in this area since water is already present in the product at this point in the process. Proper chemical usage should be observed with sufﬁcient levels of cleaner and sanitizer. In order to be efﬁcient, hoses © 2003 by Marcel Dekker, Inc.

Figure 3

Oven doors should seal tightly and be well gasketed.

capable of moving large volumes of water should be used. Small garden hoses will take forever and will not efﬁciently clean speciﬁc areas and equipment. Care must be taken with pressure sprayers, since high-pressure spray can move dirt to other areas. While running the line, the dryer the area is kept, the better off the plant will be. Cereal waste mixed with water will foster bacteria growth. Keep areas as clean and dry as possible. When dismantling the equipment, it is important not to place parts on the ﬂoor before cleaning. If available or possible, move parts to a wash room or sink that is designed for cleaning equipment. If parts cannot be moved, place them on a clean plastic or stainless steel pallet/rack before and while cleaning (Fig. 4). Do not use wooden pallets for cleaning, storing, or transporting food equipment. Generally speaking, where equipment is dry, clean it dry; where equipment is wet, clean it wet. D.

Packaging Area

Cleaning in this area should normally be done on a dry basis. Dust collection is key to keeping the packaging area clean. Packaging materials should be moved though in a ﬁrst in/ﬁrst out fashion. Large amounts of packaging materials should not be staged for long periods of time in this area. Walls should be kept clear with the usual border. E.

Finished Goods Area

The same care to keep broken or damaged product out of the raw materials warehouse should be used in the ﬁnished goods warehouse. Cobwebs should be promptly removed. © 2003 by Marcel Dekker, Inc.

Figure 4 Equipment that has been broken down should be placed on a plastic pallet for cleaning.

Figure 5 The door sweep has been damaged due to daily use and should be repaired to prevent pest entry.

© 2003 by Marcel Dekker, Inc.

Walls should be kept free and clear with 18- to 24-in white borders. Room should be kept available between aisles of product for inspection purposes. Floors should be swept frequently (at a minimum weekly, if not daily) and any broken pallets promptly removed. All materials should be stretch wrapped in this area. If pallets are stacked, a slipsheet should protect the top tier of product from the bottom of the second and subsequent pallets. F.

Building(s) and Grounds

The interior and exterior of the building(s) should be maintained in such a manner as to eliminate or reduce pest entry. On the interior of the building, be certain that there is no damage to the structure that allows pests or rodents to enter the building. There should be properly placed mousetraps in the facility. Check all door and window jambs, door sweeps, screening, and other potential entry points (Fig. 5). During regularly scheduled inspections, be careful to observe any areas such as cracks and crevices where dust may gather and insects can live. Furthermore, it is important to evaluate the location and design of the openings through walls for items such as electrical lines, ventilation ducts (proper screening on fans), and plumbing. Interior walls, ﬂoors, and ceilings should be of a smooth and impervious material (Figs. 6 and 7). When cracks develop in these areas, it is imperative that they be repaired immediately. On the exterior of the building, the property should be maintained so that no harborages exist up alongside of the building. This can allow pests to get into the interior. Grasses should be maintained and trimmed on a regular basis. Bushes and trees should not be up against the building, as they may become ‘‘homes’’ for unwanted guests into the facility. Rodent stations should be placed outside of the building to reduce the number of pests that may want to gain entry into the facility (Fig. 8). During the exterior inspections, the inspector should also look for stored equipment, pallet storage, or other outdoor storage.

Figure 6 This area was designed with an angled slope from the wall to the ﬂoor to reduce water build-up at the ﬂoor–wall junction. © 2003 by Marcel Dekker, Inc.

Figure 7 This is an example of a ceiling that is easily cleanable.

Figure 8 This exterior rat trap is used to prevent rodent entry into the facility. © 2003 by Marcel Dekker, Inc.

All of these items can provide harborages for pests. Also include the roof as part of the regular inspection. There may be standing water or organic matter accumulating. This will also provide for an inspection of the equipment on the roof to be certain of cleanliness and condition. It is important to maintain a well-lit facility. Exterior lighting should be anchored away from the building if possible so insects are not attracted to entry points. Many insects, rodents, and pests like to live in cool dark places. II. INSPECTION Learning how to do proper inspections is something all employees should be familiar with. This includes learning about ingredients, packaging materials, pests, and equipment. The cooperation of all employees is essential in keeping the management informed of any unsanitary conditions or other possible issues. As mentioned earlier, it is imperative to do inspections of the interior and exterior building and grounds. More information on this can be located in the Code of Federal Regulations (21CFR 110). Equipment inspection begins at the point just before it is brought into the facility and continues until it is no longer in use or is discarded. Beginning at equipment entry, it should be inspected for unwanted pests and safety hazards. Once installed, it should be on a continual documented inspection program along with all other equipment in the facility. During these inspections, the equipment should be evaluated for dead spaces where grain material may accumulate. Areas that are not easily or readily seen should also be on the inspection list. Inspection of the storage areas is extremely important as they directly relate to the quality of the ﬁnished products produced. This inspection includes all raw materials, ﬁnished products, packaging materials, and equipment. In these areas, there needs to be adequate ventilation for products stored and space to conduct the inspection. It is important during these inspections to be certain that product is on a ﬁrst in ﬁrst out (FIFO) rotation cycle. This does not allow raw materials or ﬁnished product to age unnecessarily. It is equally important to keep adequate space in the aisles between and around the product for both cleaning and inspection. III. PEST CONTROL Working in the breakfast cereal industry requires a vast knowledge in the area of pest control. This includes insect, rodent, and bird control. In all cases, it is important to learn the life cycles and feeding habits of the pests that may enter the facility. A.

Insects

Insect pests encountered in the cereal foods industry fall into four basic categories according to their feeding habits: internal feeders, external feeders, scavengers, and secondary pests. The basic categories relating to plant sanitation, or more precisely, lack of adequate cereal plant sanitation are the scavengers, since they typically feed on damaged grains or grain dust. The most important pests of stored foods in the scavenger category include the confused ﬂour beetle, the red ﬂour beetle, the ﬂat grain beetle, the sawtoothed grain beetle, © 2003 by Marcel Dekker, Inc.

and the Mediterranean ﬂour moth. They typically do not feed on whole, intact kernels of grain, but upon damaged or processed grain products, including grain dust. The confused ﬂour beetle and red ﬂour bettle are very small, about 3 mm in length and are a reddish brown color. They are very similar in size, appearance, and habits. Because of the small size and chewing mouthparts, they are capable of working into many sealed containers, including multiwall paper bags and cardboard boxes. They can be distinguished from one another by the morphology of the antennae. The confused ﬂour beetle antenna is gradually enlarged to form a four-segmented club, whereas the red ﬂour beetle antenna enlarges abruptly to form a three-segmented club. The adult confused ﬂour beetle does not ﬂy, but the adult red ﬂour beetle is a strong ﬂier, which may account for the much more frequent appearance of this insect in farm stored grain. Both are primarily a pest of milled grain products—grain dusts and surfaces of broken grains. The ﬂat grain beetle is one of the smallest of the common grain-infesting insects. Adults are ﬂattened, oblong, reddish brown and about 1 to 2 mm long. The distinguishing characteristic is the antennae are slender and are about two-thirds as long as the insect body—much longer in relation to the body than the antennae of the other grain investing species. These insects mainly feed on damaged, decaying matter and the fungi associated with it. The sawtoothed grain beetle is similar in size and color to the ﬂour beetles. It is distinguished by six sawlike projections on each side of the thorax. It, like the confused ﬂour beetle, does not ﬂy. Again, it is associated with milled grain products. The Mediterranean ﬂour moth is a common pest, infesting such items as ﬂour, nuts, chocolate, beans, spices, and dried fruits. Adults have a wingspan of about 1-in. The front pair of wings is pale gray with wavy dark lines running across them. The hind wings are dirty white. Females lay their eggs in accumulations of ﬂour or other milled products. As the larvae feed on the grain product, they spin silken threads. The threads fasten particles together in a dense mat that is very characteristic of this insect. Other grain infesting insects of importance to cereal mills are the cigarette beetle and the closely related drugstore beetle. The cigarette beetle is about 0.1 in. long, stout, and oval with the head bent down nearly at a right angle to the body. It breeds in a variety of seeds and may occasionally be found attacking grains left in storage in the original sacks for long periods. The drugstore beetle is very similar in appearance, but is slightly more elongated and has distinctly striated wing covers. It is a very general feeder, attacking a wide variety of stored foods, seeds, and other grain-based foods. B. Rodents The three most commonly encountered rodents in the United States are the house mouse, the Norway rat, and the roof rat. Because grain and ﬁnished grain products can provide a nearly complete nutritionally balanced food source for rodents, it is imperative to maintain an active rodent control program. Both droppings and urine can transmit human and animal diseases. This is why it is necessary to carefully monitor both the raw materials and ﬁnished products. Though all of these rodents have many similarities, they each have their own habits too. It is necessary to know exactly which is causing the problem in order to control them properly. The house mouse tends to be one of the more difﬁcult rodents to control due to its © 2003 by Marcel Dekker, Inc.

size and body ﬂexibility. The adult mouse is typically only 6–7 in. long (including tail) and will only weigh between 0.5 to 0.75 oz. The tail of a mouse is slightly longer than the combination of both the head and body. The female may begin reproducing around 1.5 months of age. They can wean an average of 30 to 35 young per year. The mouse does not require a water source for survival as their bodies can get enough water from the foods they eat. Although the mouse can live indoors or outdoors, they prefer living indoors in dark secluded areas such as stored food products or equipment not in use. The Norway rat is the larger of the rodents. They weight between 10 and 17 oz. as an adult and measure up to 18 in. long from nose to end of tail. In the case of the Norway rat, unlike the mouse, the tail is equal to or shorter than the combination of the head and body. Norway rats differ from mice in that they require water as well as food to meet their nutritional requirements. They also have been found to live in burrows, basements, tunnels, and sewers. It is well known that they can swim and can be found in sewer systems and can gain access to a food plant by poorly maintained drain covers. The roof rat is, as its name suggests, usually found on the roof or trusses of buildings. The roof rat is named as such because of its phenomenal ability to climb. They have been spotted walking on electrical or phone wires, climbing trees, and building materials. The roof rat is smaller than the Norway rat and larger than the house mouse. It can be easily identiﬁed by the fact that the tail is longer than the combination of the head and body. When full grown, the roof rat will usually weigh between 8 and 12 oz. It has fairly large eyes (larger than the Norway rat or house mouse). They are usually found along the paciﬁc coast or warmer southern climates. Water, along with food, is also a nutritional requirement for these rodents. C.

Birds

Controlling the bird population can be difﬁcult because they can live both inside and outside a building. A ﬁrst concern with birds is their ability to contaminate food products as well as their nests being used by other insects as a harborage. However, before developing a plan to rid your facility of birds, check with a regulatory agency in your area. There are only three birds considered to be pests or nuisances. These are the English sparrow, the feral pigeon, and the European starling. The remaining birds are federally protected to some extent. Some birds are known to feed together such as the feral pigeon and the mourning dove. This can cause difﬁculty in the control of pigeons, especially if a baiting program is being implemented to kill pest pigeons, which may cause the mourning doves to die as well. If the public becomes aware of this situation, they may become upset as most people see feeding birds as assisting nature ﬁnd food. They do not see birds as pests. Some birds may have come to a plant to build their nests, lay eggs, and raise their young. There are certain factors that may exist in the building that would cause them to ﬁnd this a desirable location to live. These would include overhead light ﬁxtures attached to the building, gutters, signs mounted to the building with a little space behind them, or outdoor bushes or shrubs. Before starting a bird control program, be certain to know what type(s) of bird needs to be controlled. Determine their behavior. Evaluate where the birds come from and where they go when they leave the facility. Are they just there to loaf or are they there to roost? If personnel in the food plant are not well versed in bird control, a professional should be called in to conduct an evaluation of the situation. These profes© 2003 by Marcel Dekker, Inc.

sionals are experienced and knowledgeable of the regulatory ramiﬁcations for your location. In all cases, it is necessary to eliminate food sources available to them. Be certain as grain is unloaded that spills are cleaned up and any residual grain is treated to make it unappetizing to birds as well as other animals. Keep the buildings in repair so that the birds may not enter. This includes screening all vents (Fig. 9), windows, and doors that may be left open for air circulation. Using repellents may be necessary. Different types exist, including sonic, visual, chemical, and mechanical devices. Trapping birds in cages can be difﬁcult. It is easier with some types of birds than others based on their feeding habits. Finally, the use of avicides is advised only in the case of all other methods failing. Only use avicides if they meet all federal, state, and local regulations. Be certain to check out all regulations before using avicides and follow all label instructions. IV. HACCP PLAN Food safety plans are a large part of maintaining a sanitary environment for food production. Hazard analysis and critical control point (HACCP) plans are preventative and are designed to reduce the risk in food manufacturing. There are many prerequisite programs that HACCP is based on. All of these prerequisite programs (the foundation of HACCP) are what is used to control the plant environment that contributes to the overall safety of the product. Without these essential programs, the development of a HACCP program should not be undertaken. The HACCP system requires strict adherence to these prerequisite programs. The following list names just some of the prerequisite programs that may be necessary to develop a useful HACCP plan. (Since each plant differs slightly, this list is intended to be a typical list that may apply to many manufacturing facilities.)

Figure 9 An example of screening used to keep birds and pests out of the building. © 2003 by Marcel Dekker, Inc.

Good manufacturing practices Building and grounds Utility systems Water quality Sanitary facilities Sanitation Pest control Housekeeping Product or ingredient storage Carrier inspections (incoming and outgoing) Receiving and storage Hold release policy Equipment calibration Equipment design Preventive maintenance Employee training General quality systems Recall procedures Laboratory testing approval Health and safety recalls Distribution Code dating Letters of guarantee Residual chemical testing Self-life Rework Environmental testing program Raw material testing Once all of the prerequisite programs are in place, a HACCP plan can be developed. To begin the development of a HACCP plan, most facilities will draw a ﬂowchart of their process from raw receiving to ﬁnished product shipping. After the ﬂowchart is drawn, it is recomended that a hazard analysis and risk assessment be performed. A cross-functional team should do this assessment, if possible. This may include personnel from quality assurance, production, microbiology, operations, and others as appropriate. When conducting this assessment, look at potential hazards as they exist (biological, chemical, and physical) for each potential hazard associated with the product or process. Items that are already controlled through prerequisite programs should not be considered CCPs. Begin to develop the written form of the HACCP plan. A typical ﬁnal CCP documentation chart should include the following seven columns. CCP number; signiﬁcant hazard; critical limit; monioring (what, how, frequency, who); corrective actions; records, and veriﬁcation (Table 1). Once completed, train all employees how HACCP ﬁts into their daily jobs and how this preventative program provides a safer ﬁnished product. The ﬁnal step in a HACCP plan is veriﬁcation. This assures that the plan is working. These types of food safety programs and all of the prerequisites determine the safety of the foods produced, assist in maintaining a clean and sanitary facility and reduce the possibility of problems throughout. Having the knowledge within a facility as related to sanitation, pest control, manufacturing, processing, and packaging provides the opportu© 2003 by Marcel Dekker, Inc.

Table 1 Critical Control Point Documentation Chart Critical Critical control limits Monitoring point Signiﬁcant for each Corrective number hazard measure What How Frequency Who action Records Veriﬁcation

nity for a sanitary cereal food plant. Both the American Association of Cereal Chemists and the American Institute of Baking offer workshops on HACCP. REFERENCES 1. TJ Imholte. Engineering for Food Safety and Sanitation: A Guide to the Sanitary Design of Food Plants and Food Plant Equipment, 2nd Ed. Woodinville, WA. Technical Institute of Food Safety, 1999. 2. RB Fast, EF Caldwell, eds. Breakfast Cereals and How They Are Made, 2nd Ed. St. Paul, MN: American Association of Cereal Chemists, 2000. 3. Lauhoff Grain Company. A guide to good manufacturing practices for the food industry. Danville, IL: Lauhoff Grain Company, [continuous publication], 1967, 1978, 1978, 1991. 4. R Mills, J Pedersen. A Flour Mill Sanitation Manual. St. Paul, MN: Eagan Press, 1990.

© 2003 by Marcel Dekker, Inc.

28 Plant Sanitation and HACCP for Fruit Processing ANDI SHAU-MEI OU and WEN-ZHE HWANG National Chung Hsing University, Taichung, Taiwan SHENG-DUN LIN Hungkuang Institute of Technology, Taichung, Taiwan

I.

INTRODUCTION

Fruit is an important food in our life. It provides us with rich vitamins, minerals, ﬁber, pectin, organic acids, sugars, and other compounds contributing to all the sensory qualities such as color, ﬂavor, texture, and taste for eating enjoyment. It can also associate with other foods to balance our diet and maintain our health and activity. As civilization developed, scientiﬁc techniques and promotion of trade economics have made fruit production no longer the work of a few farmers; it has become an enterprise business as well. It not only supplies the needs of local markets, but also is an important item in international trade. Due to superior location, climate, production techniques, and hard-working farmers, Taiwan produces various tropical, subtropical, and temperate fruits such as banana, pineapple, citrus, watermelon, grapes, wax apple, litchi, guava, papaya, passion fruit, apple, pear, peach, plum, etc. They are quite common not only for local consumption but also for export. In Taiwan, many fruit products are available to consumers in the market. Besides the fresh fruits, many processed fruit products, such as juices, minimally processed fruits, vinegar, wines, canned fruits, frozen fruits, dried fruits, candied fruits, jams, jelly, and preserves, are also available. However, during processing and distribution, contamination from biological, chemical, or physical sources may cause these products to become dangerous. The hazards mostly come from raw materials, unclean equipment, water sources, insects, or infected workers. To solve this problem, many manufacturers spend enormous © 2003 by Marcel Dekker, Inc.

effort to try to manage all the steps during processing or spend lots of money to inspect the safety of products, but the effectiveness is very low. Since traditional quality management cannot assure that food is safe, hazard control in each important step during processing becomes an accurate way to efﬁciently improve food safety. The hazard analysis and critical control point (HACCP) system, a systematic approach used in food production as a means to assure food safety as deﬁned by the U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF), has been developed. Although the NACMCF document only covers microbiological hazard analysis, Corlett and Stier [1] extended the system to chemical and physical hazards in food. It becomes applicable to all classes of food hazards. Therefore, it has been the most effective, well-known management system for assuring food safety in food industries throughout the world regardless of their location. Many countries have implemented HACCP into their regulations to assure food safety [2,3]. The HACCP system is based on the good manufacture practice (GMP) and sanitation standard operating procedures (SSOP). Good manufacturing practice includes all management systems established and audited for the plant environment, areas and facilities, machinery and equipment, organization and personnel, sanitation, process control, quality control, control of warehouse and distribution, labeling, consumer service, product recall, and records. Sanitation standard operating procedures includes all sanitation management on plant environment, facility, equipment, personnel, and manufacture practice [4–8]. Otherwise, fruit plants would have too many critical control points to handle. Before doing the hazard analysis, the manufacturer has to ﬁnish the following work: 1.

2.

3. 4.

5.

Establish the HACCP executive team, organized with the company owner, managers of production, quality assurance, marketing, purchasing personnel, and microbiological inspectors, to establish, audit, and execute the HACCP plan and the education program for personnel. Thoroughly describe the product characteristics and the way they are distributed. (This relates closely to the hazard analysis. The more detail the better. It includes the source of raw materials, the storage and distribution of the products, and the instruction of the product use.) Thoroughly describe the intended consumers, such as ordinary people, elderly, children, patients, etc., for the product. Establish the ﬂowchart for each product and number it for the hazard analysis and recognition of important control points, control limits, controlling methods, and correction of abnormal situations. Thoroughly make sure the production procedure in the plant on site is the same as the ﬂowchart [4,6,9].

Then, according to the seven principles prescribed by NACMCF [10], the HACCP team develops the HACCP working chart for the product. The seven principles are 1. 2. 3. 4. 5. 6. 7.

The execution of the hazard analysis The identiﬁcation of CCPs in the process The setup of critical limits for each CCP The setup of monitoring requirements for each CCP The setup of a correction strategy The establishment of simple, easily understood and effective recordkeeping procedures The veriﬁcation of the HACCP process [4–6,10–17].

© 2003 by Marcel Dekker, Inc.

This chapter mainly describes the HACCP programs in fruit processing plants, such as for canned fruits, frozen fruits, dried fruits, fruit juices, candied fruits, and fresh-cut fruits. The HACCP program includes the processing ﬂow diagrams and HACCP control charts for processing steps, hazard analysis, methods of measurements, critical limits, CCPs’, monitoring procedures/frequency, corrective actions, and records. It should be a useful reference for fruit processing manufacturers in establishing their HACCP programs.

II. CANNED FRUIT For this section, canning of pineapple rings is used as an example. Pineapple, a tropical fruit, is commonly produced in Taiwan both for the fresh market and canning for exporting. A. The Processing Flowchart The processing ﬂowchart for canning pineapples is shown in Fig. 1. Pineapple fruit is unloaded from bulk bins at the cannery and mechanically graded for size. Fruits of each size are conveyed to working tables to cut off the bottom and top of the fruit and then go through the semiautomatic shelling and coring machine to remove the shell and core. In the United States, cannery for pineapple usually uses the Ginaca machine to automatically remove the entire inedible portion of the fruit from the edible parts. The pineapple cylinders are conveyed to trimming tables, and after trimming they pass through a spray washer on their way to the slicing machine. The machine slices the cylinders transversely for packing in cans. Filled cans enter a chamber under vacuum for 5–10 sec to remove air from the fruit tissue. The cans are then syruped, sealed, and sterilized in a cooker at about 100°C until the center temperature of the can reaches 91°C. Cans are then cooled, trayed, and stored until labeling and distribution. B. Hazard Analysis and Risk Assessment Table 1 shows the hazard analysis and risk assessment work. Sources of hazards may come from raw materials or processed products; there may be microorganisms, insect bodies, and pesticide residues in the raw materials; cans may be under vacuumed or understerilized or may have sealing or other defects [18–21]. The hazards include biological, chemical, and physical sources. Biological Hazards. The incoming materials (pineapples, sugars, etc.) could be contaminated with microorganisms. Pineapples could be contaminated with bacteria, yeasts, or molds. Sucrose could be contaminated with bacterial spores and yeasts, and water could be contaminated with pathogenic microorganisms. During the processing steps, intermediate or ﬁnal products could be contaminated by microorganisms due to improper handling, and the inadequate inspection of the ﬁnal package could miss leaking cans which could become contaminated with microorganisms. Chemical Hazards. The incoming materials may contain some hazardous chemicals. Pineapples could contain pesticide residues; water could be contaminated with heavy metals and chemical residues; packaging material could be contaminated with harmful chemical residues which could leach into the product. In the © 2003 by Marcel Dekker, Inc.

Figure 1

Process ﬂowchart for canning pineapple.

processing steps, the intermediate product or product could become contaminated from cleaning chemical residues because of improper rinsing. Physical Hazard. Incoming materials could be contaminated with hazardous extraneous material (e.g., metal, plastic, and glass fragments and wood slivers). C.

Critical Control Points

The critical control points for the processing procedure are determined by a CCP decision tree and there are six CCPs obtained as shown in Table 1. Four CCPs are chosen in the step of raw material receiving and inspection, including pineapples, water, sucrose, and empty can and cap. The other two CCPs are located in the steaming and sterilization steps. D.

Critical Limits

Establishing the critical limits of each CCP for canned pineapple is based on the national sanitation regulations, experts’ suggestions, and the company’s own experience, as shown in Table 1.

© 2003 by Marcel Dekker, Inc.

Table 1

HACCP Worksheet for Critical Control Points: Canning Pineapples Monitoring

Critical control point

Hazards

Corrective actions

What

How

Frequency

Who

No spoiled fruits; no pesticide residues exceeding food sanitation standards No extraneous materials

Spoiled fruit, pesticide residues

Visual inspection, chemical analysis

Every delivery

QC inspector

Spoiled fruits are rejected.

Materials testing records (MTR)

Extraneous materials

Visual inspection

Every delivery

QC inspector

MTR

03 Water receiving MO

TPC ⱕ 100 CFU/ mL; no E. coli present

TPC, E. coli

MO analysis

Weekly

QC inspector

04 Empty can and cap receiving

Extraneous materials

No extraneous materials

Extraneous materials

Visual inspection

Every delivery

QC inspector

Reject when extraneous materials are found. Water not used if TPC ⬎ 100 CFU/mL or E. coli present. Reject when extraneous materials are found.

19 Seaming

Leaking

According to CNS 827 standards

Appearance inspection and seaming inspection after opening can

According to standards of double seamer practice

Operator

20 Sterilization

MO

Initial temperature ⬎ 50°C; sterilizer is good

Initial temperature Thermometer

Every 30 min for appearance; every 3 hr for seaming inspection Every delivery

Sterilization temperature 98°C; sterilization time 23 min

Temperature and time

Every batch

Operator

01 Pineapple receiving

Microorganisms (MO), pesticide residues

02 Sucrose receiving

Extraneous materials

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Critical limits

Visual inspection

Operator

Records

Water records

MTR

Seaming record

Product reworked if applicable using the alternative process schedule.

Sterilization record

Thermometer and timer record

E.

Monitoring

Different monitoring methods for CCPs including physical, chemical, and sensory tests are used, as shown in Table 1. Visual inspection and chemical analysis are used for pineapple receiving; microbiological testing is used for water detection; visual inspection is used for sucrose and empty can and cap receiving, and the seaming step; thermometers and timers are used for the sterilization step. F.

Corrective Action

When the results of monitoring do not meet the critical limits, corrective action should immediately be taken. For example, once the raw materials do not meet the speciﬁcation, they will be rejected, as indicated in Table 1. G.

Recordkeeping

A recordkeeping system to keep correct and comprehensive records is essential for the success of the HACCP system. Records are the documentation needed to verify effectiveness of the HACCP plan. H.

Veriﬁcation

To verify the HACCP system of canned pineapples, an auditing team is organized from the company’s executive level members. They review all the safety and quality assurance records, such as the records for critical control points, the records for process deviation and corrective actions, the records for sanitation quality inspections, the records for the standard procedures of the sanitation management, and the records for the improvements and corrections of governmental inspections, etc. In addition, they should examine the accurate knowledge of supervisors for the critical control points, the critical limits, and corrective actions as well as the overall effectiveness of the HACCP system to assure the system is well undertaken. III. FROZEN FRUIT In this section, the frozen litchi is used as an example. Litchi (Litchi Chinensis Sonn.) produced in Taiwan is mainly for the fresh market and frozen products for exporting to Japan as well. A.

The Process Flowchart

The process ﬂowchart for manufacturing frozen litchi is shown in Fig. 2. the litchi is harvested during mid-May to mid-June in Taiwan. After arriving in the plant, the leaves and stems of litchi are removed as soon as possible by a roller and trimmed with trimming scissors. Litchi is then washed and individually quick-frozen by an individually quickfreezing (IQF) freezer. The frozen litchi is stored at ⫺20°C before distribution. B.

Hazard Analysis and Risk Assessment

First of all, the members of the HACCP team in the company need to collect all the information about litchi from literature and plant experience. Then they discuss the potential hazards during litchi processing from the raw materials to ﬁnished products and selling.

© 2003 by Marcel Dekker, Inc.

Figure 2 Process ﬂowchart for manufacturing frozen litchi. Table 2 shows the identiﬁed hazards, and the levels of risk associated with each identiﬁed hazard are assessed. The hazards include microbiological, chemical, and physical hazards. For microbiological hazards, many disease organisms are associated with postharvest decay of litchi; the most important are Aspergillus, Pestalotiopsis, Peronophythora, and various yeasts [22–26]. Disease control should begin with measures against fruit-piercing insects, particularly the fruit ﬂy, since cracks in the pericarp allow entry of microorganisms. However, microscopic cracks are present at harvest and increase after harvest [27]. Other microbiological hazard sources for frozen litchi include water, which could be contaminated with microorganisms, and packaging materials contaminated by the injured hands of operator, for example. The major chemical hazard for frozen litchi is pesticide residues. Others are the solvent odors and solvent residues of polyethylene (PE) bags [19–21]. The major physical hazard for frozen litchi is metal contamination. Its source usually comes from the metal surfaces of machines [19–21]. C. Critical Control Points Based on factory experimental data and experience and the relevant literatures, four CCPs are identiﬁed for frozen litchi using the CCP decision tree; these are shown in Table 2.

© 2003 by Marcel Dekker, Inc.

Table 2

HACCP Worksheet for Critical Control Points: Frozen Litchi Monitoring

Critical control point

Critical limits

What

01 Litchi receiving

Microorganisms (MO), insects, pesticide residues

Spoiled fruit; pesticide residues

Visual inspecEvery delivery tion, chemical and yearly analysis

QC inspector and operator

Fruits are rejected.

Materials testing record (MTR)

02 Water receiving

MO

No spoiled fruit; all pesticide residues must be within standards of food sanitation. TPC must be ⱕ 100 CFU/mL; E. coli absent

TPC; E. coli

Microbiological analysis

Weekly

QC inspector

Water record

03 HDPE bags receiving

Solvent residues

Solvent odor, solvent residues

Smell and solvent analysis

Every delivery

QC inspector

Water not used when TPC ⬎ 100 CFU/mL or E. coli present. Packages are rejected.

09 Metal detection

Metal

Ferrous and nonferrous metal

Automatic screening

Continuously; line operator evaluates rejects hourly.

Labeling operator

If sensitivity check of detector is not on or fails, all product since last acceptable check held and rechecked for metal. Excessive reject rate forces line shutdown. Contact maintenance if necessary, e.g., to ﬁx detector.

Metal detector result; QC prepares deviation report, determines source of metal, and corrects it.

PE package must have no solvent odor; solvent residues must be within standards of food sanitation. Operable metal detector.

© 2003 by Marcel Dekker, Inc.

How

Frequency

Who

Corrective actions

Hazard

Records

MTR

They include the steps of receiving litchi, water, PE packaging bags, and metal detection after packing. D. Critical Limits The critical limit is a safe limit for each identiﬁed CCP. In order to eliminate hazards for frozen litchi and assure consumer safety, the company’s HACCP team establishes the critical limits for each CCP from SSOP, the company’s experimental data, and experts’ suggestions. The critical limits for each CCP are described in Table 2. E.

Monitoring

Monitoring methods for frozen litchi are shown in Table 2, including microbiological, chemical, and sensory tests. The items, frequency, and responsible personnel for monitoring are shown in Table 2. All monitoring data must be recorded clearly in order to assure product safety and quality. F.

Corrective Actions

Corrective action must be taken whenever monitoring indicates that limits are not met. Such action must be immediate to assure that the situation is rectiﬁed. The corrective actions of each CCP for frozen litchi are shown in Table 2. For example, if the pesticide residues of litchi exceed standards of food sanitation, they will be rejected. G.

Recordkeeping

Records are needed to verify effectiveness. The records for frozen litchi include material testing, water, operator sanitizing, product recovery, and consumer complaints records, among others. H. Veriﬁcation In order to verify the HACCP system for frozen litchi the manufacturer operates in accordance with the HACCP plan. Regular and annual audits are performed by the company’s audit team or an external party. They review all records for frozen litchi. The result of the audits are to be discussed at management meetings. IV. DRIED FRUIT Drying has been a common processing method for fruit since ancient times. This not only demonstrates the preserving ability of fruit, but also indicates the unique ﬂavors and aromas for dried fruit compared to fresh. To dry fruit, it is necessary only to dry to the stage where microorganisms will not grow, thereby retaining the ﬂavor, color, and nutrients consumers want. In this section, dried apple slices are used as an example to illustrate the HACCP process. A. The Process Flowchart The process ﬂowchart of drying apple slices is shown in Fig. 3. Freshly harvested apples are unloaded in the factory and immediately stored in the cold room below 8°C if necessary. When a convenient processing time occurs, apples are washed, peeled, cored, and © 2003 by Marcel Dekker, Inc.

Figure 3

Process ﬂowchart for manufacturing dehydrated apple slices.

sliced. Because decoloration easily occurs after peeling, coring, and slicing, the step of soaking in the ascorbic acid solution becomes essential if the use of sodium sulﬁte solution is not preferred. After soaking, apple slices are heated by hot air at 60–70°C for 15–20 hr in a tunnel dehydrator and dried to the water content below 25%. Aluminum-laminated plastic bags are used for packaging to protect the dried apples against moisture, light, air, dust, microorganisms, foreign odors, insects, and rodents. Before distribution and sales, the end products are carefully stored under proper condition. B.

Hazard Analysis and Risk Assessment

The potential hazards for dehydrated apple slices listed by a company’s HACCP team are shown in Table 3. Apples may be infected by microorganisms and contaminated by exceeding permitted dosages of pesticide residues. Water used in the processing may be contaminated by microorganisms, especially E. coli, which must be absent in the water. The solvent odor or residues in aluminum-laminated packaging bags may be harmful and © 2003 by Marcel Dekker, Inc.

Table 3

HACCP Worksheet for Critical Control Points: Dehydrated Apple Slices Monitoring Corrective actions

Records

Every delivery QC inspector and yearly

Spoiled fruits are rejected.

Materials testing record (MTR)

Microbiological analysis

Weekly

Water record

Inspection of certiﬁcation

Every delivery QC inspector

Water not used when TPC ⬎ 100 CFU/mL or E. coli present. Reject.

Solvent analysis by smell

Every delivery QC inspector

Reject packaging materials.

MTR

Hot air temperature, drying time

Continuously

Stop processing and make adjustment

Heating record

Critical control point

Hazard

Critical limits

What

How

01 Apples receiving

Microorganisms (MO), pesticide residues

Spoiled fruit, pesticide residues

Visual inspection, chemical analysis

02 Water receiving

MO

No spoiled fruit; no pesticide residues exceeding standards of food sanitation. TPC must be ⱕ 100 CFU/mL; E. coli absent.

TPC, E. coli

03 Ascorbic acid receiving

Speciﬁcation

04 Aluminumlaminated packaging bags receiving

Solvent residues

13 Hot air drying

MO

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Speciﬁcation must Speciﬁcation be according to food additive standards. No solvent odor Solvent odor, present in packagsolvent ing; no solvent residues residues exceeding the standards of food sanitation. Hot air temperature Temperature and drying time and time must be kept between 60–70°C and 15–20 hr, respectively. Product must be continuously dried to its moisture content below 25%.

Frequency

Who

QC inspector

Automatic recording, operator

MTR

dangerous to workers and consumers. Therefore, it must be carefully examined to ensure compliance with the standards of food sanitation. In the packaging step of the ﬁnished dried apple slices, the product may be contaminated by the hands of the operators if they are injured or dirty. The culls for dehydrated apple slices could be bought by consumers and result in consumer complaints [19–21,28]. C.

Critical Control Points

The company’s HACCP team collects the factory experimental data and experience, relevant literature, and experts’ suggestions as references. Using the CCP decision tree to identify the CCPs during the processing of dehydrated apple slices, ﬁve CCPs are shown in Table 3. They include receiving apples, water, ascorbic acid, and aluminum-laminated packaging bags and hot-air drying. D.

Critical Limits

Critical limits on hazards representing the boundaries of safety for each CCP are listed in Table 3. The critical limits for each CCP are based on the relevant literature, experts’ suggestions, factory experience, and sanitation standards from the Department of Health, Taiwan, ROC. E.

Monitoring

In order to assure product safety, the HACCP team identiﬁes the monitoring methods and procedures for each CCP (Table 3). F.

Corrective Actions

The company’s HACCP team established the preapproved action plan from factory experiences, experts’ suggestions, and sanitation standards for food. Disposition of the dehydrated apple slices involved in the deviation should be determined according to the preapproved action plan. For example, when the pesticide residues in apple exceed the standards of food sanitation, they will be rejected (Table 3). G.

Recordkeeping

Each CCP for dehydrated apple slices is documented. This documentation includes the identiﬁcation of the CCP, its limits, frequency of monitoring, person accountable for monitoring, and a shift check-off sheet signed by the accountable party denoting each time the CCP monitoring procedure is performed. H.

Veriﬁcation

In order to verify the HACCP system for dehydrated apple slices is working properly, the company’s auditors review the HACCP plan, all deviations and disposition, the proper functioning and accuracy of CCP monitoring equipment, CCP records, and random collection of ingredients or product samples. © 2003 by Marcel Dekker, Inc.

V.

FRUIT JUICES

Fruit juices provide vitamins and minerals as well as ﬁbers. In Taiwan, most juices are reconstituted from imported concentrated juices. For this section, the plastic-bottled singlestrength orange juice is used as an example. A. The Process Flowchart The process ﬂow diagram for orange juice is shown in Fig. 4. Citrus is the most common fruit produced in Taiwan. However, the varieties grown in Taiwan mostly are for the fresh market. The fruit juices available in the market are mostly from imported frozen concentrates. Orange juice is not an exception. After being received, the frozen concentrated orange juice is stored at ⫺20°C until a convenient processing time occurs. To reconstitute it, the water has to be cleaned by membrane ﬁltration before use. Ascorbic acid is added to the treated water to enhance the nutrient value and prevent the oxidation reaction as well. The reconstituted orange juice is then pasteurized at 93°C for 2 min before bottling. The plastic bottles, usually polyethylene or polypropylene, are washed and heated in boiling water for 10–20 min before hot-ﬁlling. After capping, the bottles immediately are cooled to below room temperature and dried using high-velocity air. The bottles are cased in cartons and stored in a cold storage room until distribution and selling.

Figure 4 Process ﬂowchart for manufacturing orange juice from concentrated juice. © 2003 by Marcel Dekker, Inc.

B.

Hazard Analysis and Risk Assessment Biological Hazards. The primary hazard in orange juice is pathogenic microorganisms, which have the ability to survive and/or grow under the acidic condition of the juice. The most important pathogen in this regard is Salmonella because of the ability of some strains to grow under refrigeration conditions and survive at low pH [16]. The outbreak of E. coli O157:H7 associated with orange juice in 1996 [29–30] also raised concern about this pathogen. Chemical Hazards. The risk of chemical hazards may include cleaners, sanitizers, and pesticides [19–21]. Physical Hazards. Incoming materials could be contaminated with hazardous extraneous material (e.g., metal, plastic, and glass fragments and wood slivers) [19– 21].

C.

Critical Control Points

Six CCPs for orange juice processing are decided by the CCP decision tree, as shown in Table 4. They are raw material receiving and inspection, including concentrated orange juice, water, ascorbic acid, and plastic bottles and caps. The other two CCPs are located in the hot-ﬁlling and capping steps. D.

Critical Limits

The established critical limits for the CCPs described are based on national sanitation regulation, experts’ suggestions, and the company’s experience and are shown in Table 4. E.

Monitoring

The monitoring methods include physical, chemical, and sensory tests, as shown in Table 4. The items and frequency as well as the supervisor are also shown in Table 4. F.

Corrective Action

When the monitoring of CCPs indicates a deviation of a critical limit, corrective actions must be taken. Corrective actions may involve the following steps: notifying a supervisor, shutting down the process line, reprocessing, adjusting temperatures and times of process, rejecting raw materials or ingredients, and holding or recalling product in distribution, as shown in Table 4. G.

Recordkeeping

Establishing a correct and comprehensive recordkeeping system is essential to a HACCP plan because records are the documentation needed to verify effectiveness. H.

Veriﬁcation

To verify the HACCP system of orange juice processing, it is necessary to organize an auditing team from the company’s executive level members. They will review all the safety and quality assurance records, such as the records for critical control points, the records for process deviation and corrective actions, the records for sanitation quality inspections, the records for the standard procedures of the sanitation management, the © 2003 by Marcel Dekker, Inc.

Table 4

HACCP Worksheet for Critical Control Points: Single-Strength Reconstituted Orange Juice Monitoring

Critical control point 01 Concentrated orange juice receiving

Critical limits

What

Microorganisms (MO), pesticide residues

MO and pesticide residues within standards of food sanitation TPC ⱕ 100 CFU/ mL; E. coli absent

MO, pesticide residues

MO analysis, chemical analysis

Every delivery QC inspector

Fruits not accepted.

Materials testing record (MTR)

TPC, E. coli

Microbiological analysis

Weekly

Water record

Speciﬁcation must be according to food additive standards Extraneous materials absent

Speciﬁcation

Inspection of certiﬁcation

Every delivery QC inspector

Water not used if TPC ⬎ 100 CFU/ mL or E. coli present. Not accepted.

MTR

Extraneous materials

Visual inspection

Every delivery QC inspector

Product not accepted.

MTR

MO in sterilization room absent According to CNS 827 standards

MO

MO analysis

Every hour

QC inspector

Stop process.

Cap sealing test

According to cap sealing operation standards

Every 30 min Every 3 hr

Operator Operator

Stop processing and make adjustment.

Sterilization room record Seaming record

02 Water receiving MO

03 Ascorbic acid receiving

Speciﬁcation

04 Plastic bottles and caps receiving 13 Hot-ﬁlling

Extraneous materials MO

14 Capping

Leaks

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How

Frequency

Who

Corrective actions

Hazard

QC inspector

Records

records for the improvements and corrections of governmental inspections, etc. In addition, they should examine the accurate knowledge of supervisors for the critical control points and the critical limits, corrective actions, and the importance of the HACCP system as well to assure the system is well undertaken. VI. CANDIED FRUIT Candied fruits in Taiwan are one of our traditional foods with characteristic ﬂavors and texture. Although it is not a major item in our diet, it is an important and almost essential food in our amusement and relaxing hours. Candying fruits has been one of the most important methods for preserving sour fruits after harvesting since ancient times. It plays an important role on the supply–demand balance of agriculture products. In this section, crisp mei (Japanese apricot) is the example for illustrating the HACCP system for candied fruits. A.

Process Flowcharts

The process ﬂowchart for manufacturing the crisp mei is shown in Fig. 5. The fresh mei are harvested from mid-March to mid-April once a year in Taiwan. But the fresh mei used for making crisp mei are only those harvested before Spring Festival (Chinese New Year, usually in February) in order to keep the fruit’s crisp characteristics. The fresh mei are unloaded from bulk bins at the factory and mechanically graded for size, with the

Figure 5

Process ﬂowchart for manufacturing crisp mei (plum).

© 2003 by Marcel Dekker, Inc.

stems and leaves removed at the same time. After grading, the mei are vigorously mixed with 5–10% salt in a roller to remove the green and astringent substances. The mei are then soaked in the solution containing 1.25% CaCl 2 and 0.7% NaHSO 3 in the ratio of 1.5 :1 for mei for about 10 days. Before glazing, the mei are washed and glazed gradually stepwise in intervals of 10%, from 35% to 65%. Each step must reach an equilibrium sugar concentration between mei and syrup before going to the higher concentration step. The end products of crisp mei usually have a sugar concentration of around 55–60% in order to have water activity below the level of microbial growth. Otherwise, some manufacturers may add potassium benzoate as a preservative. The concentration of potassium benzoate must be lower than 1 g/kg product weight according to our food sanitation regulation in Taiwan [19–21,30–31]. B. Hazard Analysis and Risk Assessment The company’s HACCP Team initially lists all perceived microbiological, chemical, and physical hazards for crisp mei and indicates their location on the HACCP worksheet (Table 5). Microbiological Hazards. The potential hazards include the presence of bacteria, mold, and insects in raw materials, in end product, and on the hands of operators. Chemical Hazards. The potential hazards include the pesticide residues and speciﬁcation in raw materials and the sulﬁte and preservatives residues in end product. Physical Hazards. The potential hazards include extraneous materials in raw materials. C. Critical Control Points The six CCPs are identiﬁed by the CCP decision tree. The experimental data, factory experience, and the literature are available to aid the company’s HACCP team in distinguishing true critical control points. Table 5 shows the location of each CCP in the process for crisp mei. D. Critical Limits In order to assure product safety, every CCP has one or more preventive measure that must be properly controlled. Each preventive measure has one or more corresponding critical limit representing the boundary of safety. The critical limits have been established for crisp mei by the regulation and practices of sanitation standards from the Department of Health, Taiwan, ROC. E.

Monitoring

The monitoring item, method, frequency, and personnel responsible are identiﬁed on the HACCP worksheet (Table 5). For example, the quality control (QC) inspector is responsible for monitoring the sodium bisulﬁte and calcium chloride receiving steps on every delivery to ensure that their speciﬁcations are in accordance with food additive standards. All records and documents for CCP monitoring must be signed by the individuals actually doing the monitoring. © 2003 by Marcel Dekker, Inc.

Table 5

HACCP Worksheet for Critical Control Points: Crisp Mei Monitoring

Critical control point

Critical limits

What

How

01 Mei receiving

Microorganisms (MO), pesticide residues

Spoiled fruit, pesticide residues

Visual inspection, chemical analysis

Every delivery QC inspector and yearly

Spoiled fruits are rejected.

Materials testing record (MTR)

03 Sodium chloride receiving

Extraneous materials

No spoiled fruit; no pesticide residues outside standards of food sanitation No extraneous materials present

Extraneous materials

Visual inspection

Every delivery QC inspector

MTR

04 Sodium bisulﬁte and calcium chloride

Speciﬁcation

Speciﬁcation according to food additive standards

Speciﬁcations

Inspection of certiﬁcation

Every delivery QC inspector

05 Sucrose receiving 06 Water receiving

Extraneous materials MO

No extraneous materials present TPC ⱕ 100 CFU/ mL; no E. coli present

Extraneous materials TPC, E. coli

Visual inspection

Every delivery QC inspector

Microbiological analysis

Weekly

QC inspector

12 Crisp mei

Sulﬁtes, MO, preservative

Sulﬁte, MO, and preservatives residues within standards of food sanitation

Sulﬁtes, preservatives, MO

Chemical and MO analyses

Every batch

QC inspector

Reject when extraneous materials are found. Reject when either one does not meet the supply speciﬁcation. Product not accepted. Water not used when TPC ⬎ 100 CFU/mL or E. coli is present. Discard when preservatives or MO residues present.

© 2003 by Marcel Dekker, Inc.

Frequency

Who

Corrective actions

Hazard

Records

MTR

MTR Water record

Product record

F.

Corrective Action

Table 5 lists the corrective actions to be taken for any failure at each CCP. For example, when the pesticide residues in mei exceed the standards of food sanitation, the QC inspector must report the deviation to the plant manager and quality control, and the mei must be rejected. G.

Recordkeeping

The monitoring of the CCPs for crisp mei are properly documented and recorded in a suitable format, validated, and signed by the responsible person. All records are kept for at least 1 year. H. Veriﬁcation In order to assure all CCPs are under control and that any corrective action is implemented, the company’s auditors review all records for crisp mei. The results of the audit are then discussed with relevant personnel, including the factory management team or QC management. VII. FRESH-CUT FRUIT Recently, ready-to-eat foods, e.g., fresh-cut fruit slices, have become popular. However, freshness and safety should carefully be examined. Fresh-cut fruit slices may consist of a single type of fruit or a combination of many types of fruits. The contamination of microorganisms from different sources may cause serious safety problems. In this section, fresh-cut watermelon slices is the example for illustrating the HACCP system of freshcut fruits. A. The Process Flow Diagram The process ﬂow diagram for manufacturing the fresh-cut watermelon is shown in Fig. 6. Watermelon received in the plant is put into a cold room for storage. Before processing, watermelon is washed in a washing tank and then transferred to a working table to peel and slice. The slices are dipped in a mixture of sugar and ascorbic acid solution for a certain time when necessary. The slices are then weighed and placed in a polystylene foam tray and wrapped with the polyethylene ﬁlm. The products are stacked in a paperboard carton in place and stored at 4–7°C in a cold storage room before distribution. The numbers in the ﬁgure represent all the important critical points which should be carefully controlled for microbiological, chemical, and physical hazards, as shown in Table 6. B. Hazard Analysis and Risk Assessment Biological Hazards. The raw material watermelon could be contaminated with spoilage and/or pathogenic microorganisms. Water received also could be contaminated with pathogenic microorganisms [19–21,28,30a,32–36]. Chemical Hazards. The incoming materials may contain hazardous chemicals. Watermelon could contain pesticide residues; water could be contaminated with heavy metals and chemical residues; packaging material (polystylene foam tray and wrapping ﬁlm) could be contaminated with harmful chemical residues which © 2003 by Marcel Dekker, Inc.

Figure 6

Process ﬂowchart for manufacturing fresh-cut watermelon slices.

could leach into the product. In the processing steps, the intermediate product or end product could become contaminated from cleaning chemical residues because of improper rinsing. Physical Hazards. Incoming materials could be contaminated with hazardous extraneous material (e.g., metal, plastic, and glass fragments and wood slivers). C.

Critical Control Points

Four CCPs for the processing of packaged fresh-cut watermelon slices are chosen by CCP decision tree, as shown in Table 6. All of them are located in the steps of raw material inspection and receiving, including watermelon, water, polystylene foam tray, and wrapping ﬁlm receiving. D.

Critical Limits

The established critical limits of each CCP for the packaged fresh-cut watermelon slices are based on the national sanitation regulations, experts’ suggestions, and the company’s own experience, as shown in Table 6. E.

Monitoring

As shown in Table 6, the monitoring methods for CCPs include physical, chemical, and sensory tests. The items and frequency as well as the supervisor are also shown in Table 6. © 2003 by Marcel Dekker, Inc.

Table 6

HACCP Worksheet for Critical Control Points: Fresh-Cut Watermelon Slices Monitoring

Critical control point

Critical limits

What

Microorganisms (MO) and chemical contamination, e.g., MO or pesticide residues on watermelon surface MO contamination

No spoiled fruit; no pesticide residues beyond standards of food sanitation.

Spoiled fruit, pesticide residues

Visual inspecEvery delivery QC inspector tion, chemical and yearly analysis

Fruits are rejected.

Materials testing record (MTR)

TPC must be ⬍ 100 CFU/mL; no E. coli present.

TPC, E. coli

Microbiological analysis

Weekly

Water record

03 Polystylene foam tray receiving

Chemical contamination, e.g., solvent residues

Solvent odor, solvent residues

Solvent analysis by smell

Every delivery QC inspector

04 Wrapping ﬁlm receiving

Chemical contamination, e.g., solvent residues

Polystyrene foam tray must have no solvent odor or solvent residues beyond standards of food sanitation. Wrapping ﬁlm must have no solvent odor or solvent residues beyond standards of food sanitation.

Water not used when TPC ⬎ 100 CFU/mL or E. coli present. Foam trays are rejected.

Solvent odor, solvent residues

Solvent analysis by smell

Every delivery QC inspector

01 Watermelon receiving

02 Water receiving

© 2003 by Marcel Dekker, Inc.

How

Frequency

Who

Corrective actions

Hazard

QC inspector

Wrapping ﬁlms are rejected.

Records

MTR

MTR

F.

Corrective Action

When the hygienic condition of packaged fresh-cut watermelon slices does not meet the national sanitation standards, corrective action should immediately be taken. For example, once the raw materials do not meet the speciﬁcation, they will be rejected, as indicated in Table 6. G.

Recordkeeping

Keeping correct and comprehensive records is essential for assuring that the HACCP is implemented correctly and the packaged fresh-cut watermelon slices meet all the sanitation standards and quality. H.

Veriﬁcation

To verify the HACCP system of packaged fresh-cut watermelon slices, an auditing team is organized from the company’s executive level members. They review all the safety and quality assurance records, such as the records for critical control points, the records for process deviation and corrective actions, the records for sanitation quality inspections, the records for the standard procedures of the sanitation management, the records for the improvements and corrections of governmental inspections, etc. In addition, they should examine the accurate knowledge of supervisors for the critical control points and the critical limits, corrective actions, and the importance of HACCP system as well to assure the system is well undertaken.

VIII. CONCLUSION The HACCP system in seafood, meat, and poultry products has been established for some time. But for fruit and vegetable products, the HACCP system has just recently been started, even in the United States and other countries. There are many different kinds of fruits and processing methods. This chapter describes six different types of processed fruit; one kind of each is used as an example. The HACCP system described here for each type of processed fruit is based on the GMP and SSOP already established in the company.

REFERENCES 1. DA Corlett, RF Stier. Risk assessment within the HACCP system. Food Control 2(2):71–72, 1991. 2. WHO. Report of the WHO consultation on hazard analysis critical control point training. World Health Organization, Geneva, 1993. 3. MY Chen. Current situation on HACCP implementation in the global world. Food Industries 29(10):57–60, 1997. 4. SD Lin, D Chang. Implementation of hazard analysis critical control point system in frozen food plant. Bull Hungkuang Inst Technol 34:277–297, 1999. 5. TJ Ren, CY Leu, KS Kuo. Implementing the hazard analysis critical control point system in lunch-box plant. Food Sci 24:569–579, 1997. 6. KBK Wu. Hazard analysis critical control point and good manufacturing practice. Food Ind (Taiwan) 28(4):25–30, 1996.

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7. J Kvenberg, P Stolfa, D Stringfellow, E Spencer Garrett. HACCP development and regulatory assessment in the United States of America. Food Control 11:387–401, 2000. 8. RE Peters. The broader application of HACCP concepts to food quality in Australia. Food Control 9:83–89, 1998. 9. C Grijspaardt-Vink. HACCP in the EU. Food Technol 49(3):36, 1995. 10. National Advisory Committee on Microbiology Criteria for Foods. Hazard analysis and critical control point system. Int J Food Microbiol 16:1–23, 1992. 11. FL Byran. Application of HACCP to ready-to-eat chilled foods. Food Technol 44(7):70, 72, 74–77, 1990. 12. FL Byran. Hazard analysis critical control point (HACCP) systems for retail food and restaurant operations. J Food Prot 53:978–983, 1990. 13. Microbiology and Food Safety Committee of the National Food Processors Association. Implementation of HACCP in a food processing plant. J Food Prot 56:548–554, 1993. 14. Microbiology and Food Safety Committee of the National Food Processors Association. HACCP Implementation: a generic model for chilled food. J Food Prot 56:1077–1084, 1993. 15. LJ Unnevehr, HH Jenson. HACCP as a regulatory innovation to improve food safety in the meat industry. Am J Econ 78:764, 1996. 16. FL Bryan, CA Bartleson, OD Cook, P Fisher, JJ Guzewich, BJ Humm, RC Swanson, ECD Todd. Procedures to implement the hazard analysis critical control point system. Des Moines, IA: International Association of Milk, Food & Environment Sanitarians, 1991. 17. KL Joan. The HACCP Food Safety Manual. New York: John Wiley & Sons, 1995. 18. DE Akpomedaye, BO Ejechi. The hurdle effect of mild heat and two tropical spice extracts on the growth of three fungi in fruit juices. Food Res Int 31:339–341, 1998. 19. Department of Health. Law Governing Food Sanitation. Taiwan, ROC, 2000. 20. Department of Health. Enforcement Rules of Law Governing Food Sanitation. Taiwan, ROC, 2000. 21. Department of Health. Standards of Food Sanitation. Taiwan, ROC, 2000. 22. PY Huang, KJ Scott. Controlling of rotting and browning of litchi fruit after harvest at ambient temperatures in China. Trop Agric 62:2–4, 1985. 23. SS Kadam, SS Deshpande. Lychee. In: DK Salunkhe, SS Kadam, eds. Handbook of Fruit Science and Technology. New York: Marcel Dekker, 1995, pp 435–443. 24. AL Snowdon. A Colour Atlas of Postharvest Disease and Disorders of Fruit and Vegetables. Vol. 1, General Introduction and Fruits. Boca Raton, FL: CRC Press, 1990, pp 126–127. 25. DM Holcroft, EJ Mitcham. Postharvest physiology and handling of litchi (Litchi chinensis Sonn.). Postharvest Biol Technol 9:265–281, 1996. 26. A Lichter, O Dvir, I Rot, M Akerman, R Regev, A Wiesblum, E Fallik, G Zauberman, Y Fuchs. Hot water brushing: an alternative method to SO 2 fumigation for color retention of litchi fruits. Postharvest Biol Technol 18:235–244, 2000. 27. SJR Underhill, DH Simons. Lychee (Litchi chinensis Sonn.). Acta Hortic 269:181–187, 1993. 28. D Zagory. Effects of post-processing handling and packaging on microbial populations. Postharvest Biol Technol 15:313–321, 1999. 29. JM Jay. Modern Food Microbiology, 6th Ed. Singapore: APAC Publishers, 2000. 30. DI Tzen, AO Chen. Studies on the processing and storage condition of crisp mei. Food Sci 19:543–558, 1992. 30a. C De Roever. Microbiological safety evaluations and recommendations on fresh produce. Food Control 9:321–347, 1998. 31. DI Tzen, DS Taeng, AO Chen. Effects of packaging, light blanching and benzoic acid on the sanitation quality of crisp mei during storage. Food Sci 22:596–605, 1995. 32. RE Brackett. Incidence, contributing factors, and control of bacterial pathogens in produce. Postharvest Biol Technol 15:305–311, 1999. 33. A Castillo, EF Escartin. Survival of Campylobacter jejuni on sliced watermelon and papaya. J Food Prot 57:166–168, 1994.

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34. EF Escartin, A Castillo Ayala, J Saldana Lozano. Survival and growth of Salmonella and Shigella on sliced fresh fruit. J Food Prot 52:471–472, 1989. 35. SD Abbey, EK Heaton, DA Golden, LR Beuchat. Microbiological and sensory quality changes in unwrapped and wrapped sliced watermelon. J Food Prot 51:531–533, 1988. 36. BA Del Rosario, LR Beuchat. Survival and growth of Enterohemorrhagic Escherichia coli O157:H7 in cantaloupe and watermelon. J Food Prot 58:105–107, 1995.

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29 Sanitation in Grain Storage and Handling MICHAEL D. TOEWS and BHADRIRAJU SUBRAMANYAM Kansas State University, Manhattan, Kansas, U.S.A.

I.

INTRODUCTION

Sanitation or cleanliness is an overlooked component of safe and cost-effective grain storage. Good sanitary practices beneﬁt the grain manager in several key areas. Aside from the obvious safety hazards including explosions and personnel exposure when working with grain containing excess particulate matter, it is beneﬁcial to store clean grain because of the decreased costs associated with aeration and insect management. Aeration is much more efﬁcient in clean grain because of reduced air ﬂow resistance when compared with aeration in unclean grain. Unclean grain promotes rapid insect, mite, and mold activity and grain deterioration. Fumigant penetration can be affected because of smaller air spaces in unclean grain resulting in poor insect management. The effectiveness of pesticides applied to stored grain to protect against insect attack is also greatly reduced in unclean grain. The problems associated with unclean grain have been addressed by entomologists with reference to insects; mycologists with reference to storage molds; engineers with reference to aeration and drying or changes in physical properties of grain; and by safety experts with reference to explosion hazards and allergenic reactions in workers. The literature is scattered in various reputed national and international journals. Our purpose in writing this chapter is not to review all the available literature, but to provide a broad understanding about the problems associated with storing and handling unclean grain and to suggest practical techniques for mitigating these problems. Therefore, only a few relevant papers from different disciplines were selected to support our arguments. To our knowledge, this is the ﬁrst time that information from various disciplines has been summarized to focus speciﬁcally on issues pertinent to sanitation in grain storage and handling. © 2003 by Marcel Dekker, Inc.

II. DEFINITIONS Material contaminants can be separated from unclean grain, and standard procedures have been established to separate these contaminants. The level of contaminants separated from the grain is quantiﬁed for assigning a numerical grade to that particular lot of grain. This procedure is formally termed grain grading and occurs anytime grain is sold. To better understand some terms, let us examine how U.S. wheat is manually graded and how contaminants are ofﬁcally deﬁned during the grading process. A representative sample (⬃1000 g) of wheat is removed from a lot and its moisture content (wet basis) determined using an approved moisture meter (moisture is not a grade factor, but the buyer can specify the level of moisture needed). Next, material other than wheat will be systematically removed using sieves or an approved dockage tester. Dockage is ofﬁcially deﬁned as ‘‘all matter other than wheat that can be removed from the original sample by use of an approved device,’’ according to procedures prescribed in the U.S. Federal Grain Inspection Service instructions [1]. Ofﬁcial grading sieves are a 4.8-mm (0.1875-in.) round-hole sieve on the top and a 1.98-mm (0.0781-in.) round-hole sieve on the bottom. All material that is retained on the top sieve or that falls through the bottom sieve is considered dockage. Common constituents found in dockage include weed seeds, weed stems, chaff, straw, grains other than wheat, sand, dirt, and dust. For Manitou wheat grown in Canada, Sinha [2] reported 12 components in dockage. The 12 components were lambs quarter seeds, wild mustard seeds, wild buckwheat seeds, wild oats, Canada thistle seeds, red root pigweed seeds, giant ragweed seeds, perennial sow thistle seeds, ﬁne black soil, cracked and broken wheat kernels, small wheat kernels, and chaff. Wild buckwhet seeds, cracked and broken wheat, and small wheat kernels made up 62% of the total dockage. Lambs quarter seeds, wild mustard seeds, red root pigweed seeds, and ﬁne black soil made up 26% of the total dockage. Other components made up the remaining 12% of the dockage. After separating dockage from the sample, test weight (bulk density) is determined using an approved test weight (Winchester bushel) apparatus [3]. Test weight is a grade factor for all grains and is related to the processing yield and quality of the ﬁnal product. The shrunken and broken kernels, ofﬁcially deﬁned as those that pass through a 1.6-mm (0.064-in.) ⫻ 9.5-mm (0.375-in.) slotted sieve, are separated and weighed. The material still remaining in the grain sample, other than wheat, is considered foreign material. The foreign material may include insect parts, small seeds, stones, and pieces of stems. Foreign material is actually handpicked from a subsample (30 g) of the original wheat sample and then weighed. The ﬁnal step includes hand selecting damaged kernels from the remaining grain sample. Damaged kernels are those remaining broken pieces or whole kernels that are weather damaged, diseased, frost damaged, germ damaged, heat damaged, insect bored, mold damaged, or otherwise materially damaged. Grain grade and dockage are important determinants of grain value. To determine ofﬁcial grade the maximal allowable limits of any single grading factor cannot be exceeded. Table 1 shows the allowable limits of each contaminant in wheat. A numerical grade is assigned based on one, or more than one, of these grade factors. Discounts may be applied to wheat not meeting the grade factors. A grading factor not discussed in the preceding paragraphs is total defects, and it is deﬁned as the total sum of shrunken and broken kernels, foreign material, and damaged kernels. It is important to note that each numerical grade also has a maximal allowable amount for total defects. Grade is expressed at the bottom of the scale ticket as the ofﬁcial grade, the wheat class, and the percent © 2003 by Marcel Dekker, Inc.

Table 1

Grade US US US US US

No No No No No

Maximum Limits of Contaminants Found in Wheat

Dockage (%) 1 2 3 4 5

Not Not Not Not Not

counted counted counted counted counted

Shrunken and broken kernels (%)

Foreign material (%)

Damaged kernels (%)

Total defects (%)

3.0 5.0 8.0 12.0 20.0

0.4 0.7 1.3 3.0 5.0

2.0 4.0 7.0 10.0 15.0

3.0 5.0 8.0 12.0 20.0

Note: Wheat not meeting standards for US grades 1–5 is considered sample grade. Source: Ref. 1.

dockage (e.g., U.S. No. 1 hard red winter, 1.2% dockage). Dockage is a non–gradedetermining factor in the U.S. wheat grading system. However, dockage level is a negotiable contract term impacting the monetary value of the commodity. The Federal Grain Inspection Service approves the use of mechanical dockage testers in place of hand sieves to determine dockage content. Mechanical dockage testers provide more consistent results than hand sieving procedures. In addition, mechanical testers save grading personnel time, because various constituents in the grain are also separated during dockage removal. These machines house an aspirator, a riddle for removal of large materials, and three sieve carriages that hold interchangeable grains. Prior to sieving a sample, the air control (blows chaff from the kernels) and speed of the machine can be adjusted to further facilitate a variety of grains and conditions. Ofﬁcial procedures exist for conditions such as wheat with more than 0.5% cheat by weight. In this case, a sieve that removes only the cheat is added in one of the sieve carriages. The federal grain standards and practical procedures for inspecting grain are published by the United States Department of Agriculture’s Grain Inspection, Packers, and Stockyards Administration. Interested readers can obtain a copy online at http://www.usda.gov/gipsa/reference-library/ library.htm. In this chapter, sanitation is discussed with reference to constituents other than grain that occur in grain at the time of harvest, handling, and storage. The terms dockage, broken corn and foreign material (BCFM), broken kernels, dust, and ﬁne material are used interchangeably. Throughout this chapter, the term dockage is frequently used to include all of these materials that occur in bulk-stored grain or in any lot of grain. This was done deliberately, because these various constituents occur together in grain, unless the grain is cleaned prior to storage. Furthermore, the problems associated with these various constituents in grain, in terms of grain deterioration, are somewhat similar.

III. SOURCES OF DOCKAGE Dockage in harvested grain can be affected by a number of factors. Age, condition, and adjustments of harvesting machinery lead to substantial changes in dockage content. Older combines were not as sophisticated and do not have the ability to separate the wheat chaff and weed seeds from the grain as effectively compared to more modern combines. Like© 2003 by Marcel Dekker, Inc.

wise, incorrect setting, even of modern machinery, could result in excess straw or chaff in the grain. The presence of certain types of weeds in the production ﬁeld at harvest time will also contribute to increased dockage. Cheat grass (or cheat), wild rye, and pigweed are similar in size to wheat kernels, and therefore cannot be completely removed by the combine. Cheat can be such a severe problem in parts of the Great Plains that grading personnel must adjust the grading apparatus to remove cheat (technically considered dockage) before continuing with the grading process or they will overestimate the value of the load. Planting certiﬁed seed, application of chemicals, and increasing cultivation are all effective means of reducing weeds in the ﬁeld and consequently weed seeds in the harvested grain. Lyon and Baltensperger [4] showed that dockage and foreign material in harvested wheat were lower when producers followed a 3-year, as opposed to a 2-year, cropping system. Particularly during dry years, the wheat kernels may not accumulate maximal dry matter resulting in more shrunken kernels. This condition is usually brought about by climatic conditions or biological organisms (insects and molds). Machine threshing versus hand threshing results in kernels possessing various degrees of damage [5]. Even slight damage to, or ﬁssures in, seed coats makes the kernels susceptible to insect infestation. Kernel breakage during combining occurs due to impact on sound kernels and impact on kernels that have varying degrees of ﬁssures. Sharma et al. [6] found that rough rice at 17–19% moisture was more susceptible to breakage than rice at 10.7–11.5% moisture. An increase in cylinder peripheral speed and the number of passes through the thresher increased dehusking. The susceptibility to breakage in corn [7] and wheat [8] was inversely related to moisture content. Kernel breakage can occur if grain is dropped from a height into a storage facility [9] and due to pneumatic conveying [10]. The breakage in both cases was greater at lower moisture contents. There are several species of stored-grain beetles that are capable of damaging sound kernels. These species include the rice weevils, granary weevils, maize weevils, lesser grain borers, and larger grain borers. Both adults and larvae of these species cause grain damage. Feeding by adults of these species results in production of grain dust. Damage caused to grain by adult feeding provides a site of entry for storage molds, and the grain dust creates conditions more conducive for other stored-product insects such as red and confused ﬂour beetles and sawtoothed grain beetles. These species are incapable of damaging or effectively developing on sound kernels, but survive and multiply on broken kernels and grain dust [11]. The dust produced by insect feeding could affect grain bulk density. For example, the reduction in bulk density containing 0.4% of dust produced by lesser grain borers ranged from 0.5–1% [12]. Handling grain, especially corn, increases the amount of dust found in the commodity. Any time grain is handled (harvested, augered, pneumatically conveyed, dropped, aspirated, or otherwise moved), there is some abrasion (often termed scouring) of the outer seed coat or pericarp resulting in the formation of grain dust. Foster and Holman [13] found that the quantity of ﬁne material in wheat did not appreciably increase with four handlings, but corn kernels cracked and broke releasing additional ﬁne material with each successive handling. A similar study also found that dockage increased in corn with each successive transfer from one bin to another [14]. Moisture content of corn also plays a factor, as drier seeds break more readily thereby producing more dockage and dust. Grain-handling systems increase dust concentration, and typical concentrations range from 0.11–0.55% by weight [15]. The amount of broken kernels and dust produced increases with the number of times it is transferred at the elevator [16] or in overseas shipments © 2003 by Marcel Dekker, Inc.

[17]. In one of the corn lots, 2, 5, and 15 transfers resulted in 0.9, 4, and 9% breakage, respectively [16]. IV. DOCKAGE IN BULK-STORED GRAIN When grain is dropped into a storage facility, the ﬁne material, which is lighter than the grain, accumulates just below the point of fall, forming a ‘‘spout line.’’ Additionally, whole and broken kernels tend to segregate in transit due to continuous vibration. Corn containing 2–3% of ﬁne material had more than 50% accumulated in the spout line area [18]. Hall [19] showed that corn containing 4.4% ﬁne material had up to 27% in parts of the spout line. He showed that the width of the spout line in stored corn was related to the particle size of the ﬁne material. His data showed that accumulation of ﬁnes in stored wheat was not as great as in corn, because in the former case ﬁnes were carried with the wheat. Data from 31 bins at 18 elevators in Kansas storing wheat sampled over a 7.6 month period showed that the bins contained an average of 1.4% ﬁne material (range 0.5–4.2%) [20]. Wheat stored on farms in Kansas sampled in September, November, and January had 1.1% ﬁne material (range 0.4–2.5%). Reed and Pedersen [21] reported that the amount of ﬁne material in farm-stored wheat (after passing through a 0.16-cm ⫻ 0.95-cm oblonghole sieve) was greater in the bin center (3.1%) than in other bin positions (range 2.5– 2.7%). They reported that the center spout line was present in many bins, but the degree of accumulation was not as heavy as those reported by Hall [19]. These spout line areas are conducive for insect and mold activities. The type of insect species, for example, those that attack sound kernels (internal feeders) or those that prefer broken kernels and dockage (external feeders), associated with bulk-stored grain may be related to the distribution and amount of dockage present. Dry grain heating due to insects or wet grain heating due to molds [11] in bulk-stored grain generally starts in spout line areas. Grain heating because of fungal activity and subsequent grain deterioration is common in spout line areas [22]. Heavy infestations of 17 insect species and 14 mite species developed in 18 hot spots in stored wheat, oats, and barley in 13 farm granaries in Manitoba and Saskatchewan, Canada [23]. A portion of the dockage in grain accumulates under the false bin ﬂoor or on the bin ﬂoor after all of the grain is withdrawn from a bin. Unless bins are cleaned before storing new grain, the residual dockage in the bins serves as an excellent site for supporting insect infestations. In uncleaned bins, application of a residual insecticide does not provide effective insect control, because the dockage particles absorb the applied insecticide and very little is available for insect contact (see Section V.C). In addition, the presence of food helps the insects survive insecticide exposure. The efﬁcacy of residual pesticides is improved on clean dust-free surfaces. Therefore, sanitation of empty bins followed by a residual pesticide application is essential for controlling insects [24]. Grain producers are very conscientious about bin sanitation. Producer surveys done in 1984 and 1986 in Kansas [21] showed that 96.5% of the producers swept empty bins, and 79% treated bins with an insecticide. Grain cleaning removes dockage, but only 2.4% of the producers cleaned wheat before storage [21]. A 1991 survey in Kansas indicated a similar trend [25]. A recent survey of 293 producers in Idaho, Illinois, Indiana, Kansas, Michigan, Minnesota, Nebraska, North Dakota, Ohio, and Washington revealed that about 98% cleaned empty bins before ﬁlling them with grain [26]. A survey of 286 commercial elevator operators © 2003 by Marcel Dekker, Inc.

in those same states [26] showed that only 23% of operators cleaned wheat before storing it. However, barely half of these same producers resealed leaky bin bases, and less than half cleaned their handling equipment. Another national survey of producers [27] showed that 14.5% of farmers vacuumed bin ﬂoors, and only 5.8% of farmers hosed down empty bin walls. In many farm bins and country elevators, dust collection systems for segregating dust from grain are impractical or cost prohibitive. As farm-stored grain is moved into country elevators, safety and health-related issues and deterioration by insects and molds due to the presence of dust continue to occur. In the elevator system, grain movement results in grain dust accumulation at various locations of the facility. This accumulated dust serves as a feeding or oviposition site for stored-grain insects. For example, grain dust sampled from several locations within four elevators in Kansas revealed that they contained dermestid larvae [28]. Insects colonizing grain dust residues can later infest grain stored in bins or grain that has been recently fumigated. Therefore, sanitation of not only the grain, but also the facilities holding and handling the grain should be practiced on a regular basis to minimize insect and mold problems.

V.

PROBLEMS ASSOCIATED WITH DOCKAGE

A.

Moisture Distribution

Moisture transfer in grain occurs predominantly by convection when there are differences between the outdoor and grain temperatures [29]. When outdoor temperatures are warmer relative to grain temperatures, the outer grain layers get warmer at a faster rate than the grain center. Air movement in the bin periphery is upward, and air movement near the bin center is downward. The convection currents result in moisture condensation at the bin bottom. When outdoor temperatures are cooler than grain temperature, grain near the bin periphery cools faster than at the bin center, resulting in moisture condensation near the grain surface [30]. Mathematical models predicted that convection currents increased grain moisture content by 2 percentage points [29], although increases of 3–5 percentage points have been observed by some researchers. Moisture migration and problems associated with moisture accumulation, such as insect and mold deterioration, are more common in unaerated bins than in aerated bins. Reed and Worman [25] reported a 3% moisture increase of the surface grain layers from August to February in unaerated farm bins in Kansas. Moisture migration occurs because of nonisothermal conditions within the grain mass. The presence of dockage may affect the movement of air through the grain mass and indirectly affect moisture transfer within the grain bulk. The presence of ﬁne materials in the spout line area may result in greater accumulation of moisture in this fraction relative to the grain, because the smaller dust particles with greater surface area–to–volume ratios tend to be more absorptive. However, a recent study showed that ground and whole corn kernels equilibrated to the same moisture content at a given temperature. Throne [31] showed that at 30°C and 43 and 75% RH, ﬁnely cracked, medium cracked, coarsely cracked, whole slit, and whole undamaged corn kernels equilibrated to the same moisture content (at each of the humidities). At 43% RH all fractions of corn and whole corn equilibrated to about 10.3% moisture, while at 75% RH the whole and processed corn components equilibrated to 14.7% moisture. Nevertheless, the presence of ﬁne material with high moisture content favors rapid development of insects, mites, and molds. © 2003 by Marcel Dekker, Inc.

Temperature ﬂuctuations are greater near the grain surface than in other parts of the grain mass [29]. Therefore, the grain temperature near the surface increases rapidly during the day and stays warmer for extended periods than temperature in the rest of the grain bulk. High moisture, temperature, and ﬁnes are prime conditions for insect and mold population explosions. The presence of molds may favor establishment of a variety of insect species that feed on molds, such as hairy fungus beetles, square-nosed fungus beetles, and foreign grain beetles. B. Insect Infestations Flinn et al. [32] reviewed the effects of ﬁne material in grain on insect infestations, and their major conclusions are discussed here. The amount of ﬁne material had a minor effect on population growth rates of insects in wheat, but had a major effect on insects in corn. The population growth rates of internal feeders, such as lesser grain borers and weevils, were not inﬂuenced by the amount of ﬁne material, because they are capable of damaging sound kernels. The sawtoothed grain beetle, an external feeder, required ﬁne material for optimal growth. The survival, development, and progeny production of insects are affected by the condition of grain. For example, maize weevils prefer whole kernels and develop less effectively on cracked kernels or ﬂour, whereas red ﬂour beetles do well on ﬂoury materials as opposed to whole kernels. Table 2 shows progeny production of maize weevils and red ﬂour beetles in whole, cracked, and ﬂour components of pearl millet [33]. In whole sorghum, maize weevils produced about 18 times more progeny than on ﬁnely ground ﬂour [34]. The proportion of dockage inﬂuenced infestation of wheat by red and confused ﬂour beetles [35,36]. White [37] reported that the exposure of germ in damaged kernels was necessary for survival of young red ﬂour beetle larvae, and the rate of development was related to the degree of germ exposure. Cline [38] showed that the ﬂat grain beetle’s longevity and progeny production on whole-corn kernels, cracked corn, corn meal, or corn halves were greatly reduced at 43% RH, but not at 75 or 84% RH. Coarsely cracked corn was a better diet for this species than whole corn, meal, or halves. Sinha [2] showed that the proportion of eggs of several stored-grain insects that developed into adults varied with the amount of dockage in wheat and grain temperature. For example, wheat with

Table 2

Progeny Production in Whole or Processed Pearl Millet (300 g) Originally Infested with Maize Weevils or Red Flour Beetles

Species Maize weevil

Red ﬂour beetle

Grain condition

No. insects

Whole kernels 90% whole, 10% cracked 100% cracked Flour Whole kernels 90% whole, 10% cracked 100% cracked Flour

1342 1149 75 50 269 245 612 1417

Note: Maize weevils and red ﬂour beetles were examined 76–78 days after infestation at 26.7°C, 65–70% RH. Source: Ref. 33.

© 2003 by Marcel Dekker, Inc.

7% dockage signiﬁcantly increased the number of sawtoothed grain beetle adults developing from eggs. However, higher dockage levels adversely affected survival of foreign grain beetles at 30 and 33°C, but not at 27°C. Adult emergence of American black ﬂour beetles was highest at the 5% dockage level, whereas for red ﬂour beetles, the 10% dockage level was most favorable at 27°C. However, at 33°C red ﬂour beetles multiplied well on dockage-free wheat. Rusty grain beetle adult production from eggs was similar in wheat containing 2, 5, and 7% dockage at 27°C. However, at 33°C red ﬂour beetles multiplied well on dockage-free wheat. Rusty grain beetle adult production from eggs was similar in wheat containing 2, 5, and 7% dockage at 27°C. At 33°C rusty grain beetles did not multiply rapidly in wheat containing 5 and 10% dockage compared to clean wheat. These ﬁndings suggest that removal of dockage/ﬁnes from grain before storing may reduce infestations of external feeders. Dockage removal will not have any effect on internal feeders such as weevils and borers. C.

Reduced Efﬁcacy of Pesticides

Broken kernels and ﬁne material in grain tend to absorb the applied insecticide, making less available for deposition on kernels [39]. The amount of pesticide residue in dockage may increase with increasing dockage levels. Anderegg and Madisen [39] applied 10 ppm (w/w) malathion to 12.5% clean wheat and wheat containing 3 levels of dockage at 26°C and 60% RH, under dark conditions. They found about 88.2% of the original residue on clean grain after 2 months of storage. During the same time period, wheat containing 2.5, 5, and 10% dockage contained about 73, 67, and 53%, respectively, of the original residue. Malathion residues in dockage increased with increasing dockage levels in grain. Strong and Sbur [40] reported that malathion toxicity to granary weevils, rice weevils, and confused ﬂour beetles lasted longer on clean wheat than on wheat containing damaged kernels and ﬁne material. Malation was less effective against confused ﬂour beetles when applied to a 50% mixture of whole and cracked wheat, but was more effective when applied to 100% whole grain. [41]. Degradation of malathion applied at the rate of 11.6 ppm to cleaned sorghum, and sorghum containing 3.8% foreign material was studied over a 12-month period [42]. Foreign material did not inﬂuence the rate of disappearance of malathion. However, the authors did not show the actual amount of residue that was present at the beginning of the study. Dockage includes varying amounts of plant parts and weed seeds, and therefore it may be at higher moisture content than the grain. At the time of bin ﬁlling, organophosphate grain protectants (malathion, chlorpyrifos-methyl, or pirimiphos-methyl) are applied to grain to manage infestations in storage. The degradation of organophosphate grain protectants increases with increasing moisture contents [43,44]. Therefore, removal of such high moisture dockage improves the deposition of protectants on kernels. Furthermore, residues tend to persist longer on cleaned than uncleaned grain. Because dockage has greater absorptive ability, the effectiveness of fumigants, especially liquid grain fumigants that were used for stored grain insect control several decades ago, was greatly reduced [45,46]. These liquid grain fumigants have been banned in the United States and are no longer legal to use. Currently, phosphine is the most commonly used grain fumigant [26]. The presence of dockage may obstruct the distribution of this fumigant within the grain mass resulting in some areas receiving less than the lethal concentration required to kill the insects. © 2003 by Marcel Dekker, Inc.

The presence of dockage or dust on bin ﬂoors or elevator ﬂoors will result in poor performance of the residual pesticides such as cyﬂuthrin or diatomaceous earth, because the dust prevents insects from coming in contact with the pesticide or the insects may transfer some of the pesticide picked-up onto the dust [47,48]. In addition, the presence of food may result in insects recovering from pesticide poisoning. D. Improper Aeration Aeration involves forcing ambient air at low velocity through a static grain mass to cool the grain and eliminate temperature gradients [49]. Aeration is affected by the distribution and amount of dockage in grain. Aeration is used to uniformly cool grain temperatures to a point where insect and mite survival, growth, and reproduction are greatly minimized. Depending on the species, this temperature is generally around 20°C or below. Reed and Worman [25] reported that 76.5% of Kansas farm–stored wheat was equipped for aeration. However, only 64% of producers and 66% of elevator managers actually aerated their wheat. Aeration is more effective in clean grain than in grain containing dockage. Fines accumulated within the interstitial spaces of kernels offer resistance to airﬂow during aeration or grain drying, resulting in inadequate aeration or drying. E.

Problems During Unloading

The separation of ﬁne material from grains entail a cost and causes problems to grain handlers. The nonuniform distribution of ﬁnes in bins also results in grain containing varying percentages of ﬁnes, as the grain in bins is loaded into trucks or rail cars. Therefore, the ﬁrst load that is removed may have a higher percentage of ﬁnes, resulting in that lot not meeting the speciﬁc grain standards. The grain bulk as a whole may meet the grain standard, but the ﬁrst truck or railcar load may not. This may result in the rejection of the shipment or application of penalties for not meeting the grade/contract requirements. F.

Safety and Health Hazards

Grain dust can cause human health problems and create a safety hazard. Potential health hazards include occupational respiratory diseases and irritation to the eyes, ears, nose, throat, or skin. The Occupational Safety and Health Administration standard [50] for worker exposure to dust is 15 mg/m3 for total and 5 mg/m3 for respirable fractions. Grain dust can impair visibility in the general working area (dump pit or elevator head house), cause unpleasant odors, and decrease employee morale and productivity. These situations potentially lead to negative community relations depending on the proximity to other commercial or residential structures. Most dust control systems at grain elevators do not separate and capture all dust particles. Instead they mimize dust levels in worker areas. The operation of dust control systems has little effect on dust concentrations inside elevator legs [51]. The level of dust in these legs can provide the fuel needed for dust explosions, provided other conditions such as oxygen, ignition source, and containment criteria are met. Generally, for a grain dust explosion to occur, the dust suspended in air should be less than 100 µm in aerodynamic diameter, and the suspended material must be at or above the minimum explosive concentration. Typically the accepted minimum explosive concentration of grain dust is 50 g/m3 [52]. This minimum concentration, however, varies with the dust moisture content, particle size distribution, and ratio of inert and organic dust [53]. Lesikar et al. [54] deter© 2003 by Marcel Dekker, Inc.

mined the minimum explosive concentration to be around 100 g/m3. There has been limited evidence [55] to suggest that liquid fumigants and other gases such as methane could work synergistically with dusts and cause explosions below the mimumum explosive concentrations. Therefore, potential fumigants should be evaluated with dusts to determine if they alter the minimum concentration for explosions. Small and dry dust particles heat up and explode quicker than large and moist particles. Explosions most frequently originate from vertical elevator legs. However, other conveying or processing equipment, storage bins, and dust collectors can produce suspended particulate material when they are in operation. The ignition source is commonly an overheated bearing or misaligned belt. Other sources of ignition may include welding, electric motors that are not ‘‘explosion proof,’’ and electrostatic discharge [56]. Anatomy of an explosion in a grain-handling facility consists of a smaller primary explosion, which triggers one or more much larger secondary explosions [57]. The primary explosion produces a relatively slow-moving ﬁre wave and a fast-moving pressure wave. The primary explosion generally ruptures the leg housing or containment, while the concussion and resulting pressure wave will cause dust resting on beams, equipment, overhead pipes, walls, and the ﬂoor to become airborne. All of this newly suspended dust then gets ignited when the ﬁre wave reaches that area, often resulting in severe damage and death. Secondary explosions can produce pressures exceeding 551.6 kPa (80 psi). To put this into perspective, only 13.8 kPa (2 psi) is needed to knock down a brick wall [56]. G.

Penalties at Time of Sale

Dockage and foreign material in grain could result in price or weight discounts applied at the time of sale. In Kansas, 41.2% of producers indicated that their wheat delivered to elevators received a price discount, whereas 59% of producers indicated that they received a weight discount. The percentage of lots receiving discounts increased with an increase in dockage level [25]. VI. MINIMIZING PROBLEMS CAUSED BY DOCKAGE A.

Grain Cleaning

Grain cleaning is generally not practiced because many producers either apply a grain protectant during bin ﬁlling or fumigate the grain some time after bin ﬁlling. Economists continue to debate the ﬁnancial feasibility of removing dockage and foreign material from U.S. wheat prior to export. The equation is not always clear, because some export markets will pay a premium for grain containing low levels of dockage, while other markets do not. Webb et al. [58] expressed economic reasons for all U.S. export wheat to be cleaned to a dockage level between 0.35 and 0.40%. Likewise, Hennessy and Wahl [59] discerned that cleaning would be marginally proﬁtable when dockage levels exceeded certain limits. While additional cost is incurred when cleaning, the cleanings themselves can be sold in specialty markets for animal feed, thereby recovering some of the costs. However, Johnson and Wilson [60] proposed a series of equations that indicated why cleaning would result in increased cost for all wheat exports, even though only certain markets require lower dockage levels. If this were true, the U.S. grain would be less cost competitive in the global market. Grain elevator operators in the midwestern United States (where most of the grain is produced) have little economic incentive to provide dockage-free grain. The Kansas © 2003 by Marcel Dekker, Inc.

Grain and Feed Association member grain elevators were surveyed for their procedures regarding dockage [61]. This survey concluded that the majority of elevator operators measured and assessed for dockage at the point of sale, but only 4% of respondents actually paid premiums for cleaner wheat. A follow-up study showed that large commercial elevators (handling 2 million bushels per year) were more likely to make a proﬁt by cleaning grain [62]. Value of the cleanings themselves had a great deal of inﬂuence on the decision to clean. These data indicated that marketability of cleanings varied greatly from location to location. Hyberg et al. [63] concluded that the direct costs of cleaning wheat exceeded the domestic beneﬁts. Their reasoning was based on extensive economic data and the observation that domestic mills do not offer a premium for cleaner wheat, because the cleaning costs at ﬂour mills are static regardless of the grain condition. This study included proposed beneﬁts such as sale of cleanings and savings in transportation costs; lower costs for drying, aeration, storage, and insect control; smaller discounts for test weight, foreign material, and shrunken and broken kernels; insurance savings; and greater kernel uniformity. However, the study by Hyberg et al. [63] did not consider potential beneﬁts of cleaning, such as less dust production from repeated handling which greatly improves safety and reduces health-related hazards. Furthermore, cleaner wheat can be effectively managed by aeration [49], thereby reducing reliance on grain protectants and fumigants. The use of grain protectants and fumigants only when needed would reduce the rapid development of resistance in insects and prolong the usable life of the pesticides. Resistance in stored-grain insects to different classes of pesticides is widespread in the United States and around the world [64]. These potential beneﬁts are difﬁcult to assess from an economic viewpoint, but the outcome of the economic analysis may change if such beneﬁts are considered. B. Use of Grain Spreaders One method to overcome the nonuniform distribution of ﬁnes is to use grain spreaders. Many grain spreaders are electric. Mechanical grain spreaders are used to prevent accumulation of ﬁnes, and are more popularly believed to level the grain without manual labor. The manual or gravity models also do an excellet job of distributing the ﬁnes. Only 15% of wheat producers (n ⫽ 48) and 17% of corn producers (n ⫽ 41) in Minnesota used spreaders [65]. A recent national survey [27] showed that 4.4% of concrete elevators and 10.7% of commercial steel storage facilities were equipped with spreaders. Some mechanical spreaders include the Spreads-All A-3 High Capacity Spreader, Spreads-All E-2 Spreader, and NECO Grain Leveler. These spreaders were described in detail by Stephens and Foster [66]. The ﬁrst two spreaders rotate about a vertical axis, and the latter one is no longer in production but has a revolving horizontal auger with a perforated outer tube that is suspended at the center of the bin and rides on a track installed at the bin eave [66]. In dry corn containing less than 6% ﬁnes (foreign matter), ﬁlling the bin with a vertical spout in the bin center resulted in 12–25% of ﬁnes accumulating just below the spout and about 2% accumulating near the walls. However, when a spreader was used, the ﬁnes ranged from 4–10% near the bin center and 1–3% near the bin walls. All three spreaders performed similarly. The spreaders helped in uniformly distributed the ﬁnes within the bulk-stored corn. The use of grain spreaders increased the grain bulk density by 13–20%. This increase in bulk density is a result of ﬁnes ﬁlling in the void spaces among kernels. Furthermore, a reduction in void spaces reduces the radius of the © 2003 by Marcel Dekker, Inc.

intergranular spaces and increases its length, thereby increasing resistance to airﬂow. Therefore, when mechanical spreaders are used, airﬂow rates for aeration or drying should be increased to compensate for the increased resistance. Consequently, the power costs will also increase with increased airﬂow rates [66]. C.

Coring

Another effective method for removing ﬁnes and trash from the grain is to unload the core (grain in the bin center) from each 60- to 120-cm (2- to 4-ft) layer as the bin is being ﬁlled. After ﬁlling the structure, a few loads should be removed (through the bottom of the structure) until an inverted cone of half the bin diameter is formed [30]. Less than 30% of producers and commercial grain operators followed this practice [26]. D.

Use of Oils

The ﬁne material in stored-grain facilities may contribute to dust explosions [67], as well as adversely affect the health of grain handlers exposed to it [68]. Explosion prevention through engineering has been investigated with ventilation (dust collection) and oil applications to reduce dust suspension in air at grain transfer points. Ventilation systems offer the advantage of working with a diversity of grains, and protection is not time dependent. Parnell [69] described a cyclone for air pollution abatement. Basic operating principles of centrifugal collectors are discussed by Mody and Jakhete [70]. However, ventilation systems are expensive, and dust disposal can be difﬁcult. The U.S. Food and Drug Administration in 1982 approved the use of food-grade mineral oil on grain to suppress dust. The approval included treatment of grains intended for human food at 0.02% by weight and grains intended for animal feed at 0.06% by weight [71]. Oil (mineral or vegetable) applications are relatively inexpensive and work well for short time periods. White et al. [72] determined that canola oil and white mineral oil did not appreciably change the storability of wheat in the laboratory for up to 1 year. Mounts et al. [73] showed that single 800-ppm applications of soybean oil and lecithin mixtures had no signiﬁcant odor or grade effect on soybeans, hard red winter wheat, soft red winter heat, or corn when stored for up to one year. However, Peplinski et al. [74] found that oil treatment reduced the test weight of corn. Several researchers have tested various oils for their ability to suppress dusts. Cocke et al. [75] using textile oil at 0.04% by weight on stored wheat reported that the dust levels were suppressed by 59%. Increasing the oil level to 0.07% by weight reduced dust levels by 92%. However, oil levels above 0.07% did not further reduce dust levels. They observed similar results in tests with corn and soybeans. Deodorized soybean oil and mineral oil suppressed dust levels in corn, wheat, and soybeans in commercial facilities. Oils at 0.03–0.1% were effective in reducing dust concentrations up to 90% over a 3month period [76]. Jones and Parnell [77] observed similar results with mineral oil on corn, wheat, and soybeans. Lai et al. [76] reported that water at 0.1–0.3% was an effective dust suppressant for a short time period. However, it is illegal to add water to stored grain. Rapeseed oil, used by Hsieh et al. [78] on wheat, effectively suppressed the dust, and the application of oil did not affect any functional qualities. In general, oils are effective dust suppressants and do not appreciably affect end use qualities of the grain. Do oils affect the physical properties of grain? In order to verify this, Jayas et al. [79] tested canola oil and mineral oil at 0.05–0.2% on clean wheat and wheat mixed with 5 or 10% dust to determine effects on bulk density, particle density, ﬁlling and emptying © 2003 by Marcel Dekker, Inc.

angles of repose, and friction coefﬁcients against plywood, concrete, and galvanized steel. The oils had very little effect on bulk density changes. Grain dust increased particle density because oils increased dust adherence to kernels. Grain dust increased the ﬁlling and emptying angles of repose by 37 and 23%, respectively, at the 5% dust level, and by 43 and 26%, respectively, at the 10% dust level. The addition of oil increased these angles, especially at 0.05–0.1% levels by 10–30%. Grain dust increased the friction coefﬁcient against all surfaces, except galvanized steel. Coefﬁcients were the same for wheat containing 5 or 10% dust. Oils also increased these friction coefﬁcients, except on galvanized steel. However, corrugated steel had the highest friction coefﬁcient. The authors concluded that on smooth galvanized steel, addition of oil to dusty grain increased lateral wall loads or pressures and decreased vertical wall loads. They recommend that when calculating loads on storage structures, the effects of oils and dust levels should be considered.

VII. BENEFITS OF MINIMIZING DOCKAGE LEVELS IN STORED GRAIN In this chapter, we have broadly addressed the sources of dockage, problems associated with dockage in grain storage and handling, methods for cleaning grain, and methods for suppressing dockage (dust) levels in bulk-stored grain. From the overview presented, it is abundantly clear that there are many tangible beneﬁts for removing or minimizing dockage levels in grain. These include (1) increased storage capacity, (2) reduced incidence and population growth of external feeding insects, (3) reduced mold incidence, (4) improved aeration, grain drying, and fumigation, (5) improved coverage of grain protectants and consequently improved efﬁcacy against insects, (6) a more uniform distribution of ﬁnes within the grain mass resulting in load uniformity, (7) a signiﬁcant reduction in explosion hazards, (8) improved air quality in and around grain-handling facilities, (9) decreased occupational exposure of workers to respirable grain dust fractions, and (10) potential economic beneﬁts for marketing cleaner grain. Grain that is dockage-free or grain that has very little dockage will produce less dust when processed in ﬂour and feed mills. Reduced dust levels in mills may decrease insect incidence and abundance and increase effectiveness of residual pesticides, thereby ensuring production of food or feed that is wholesome. More importantly, air quality of the mill environment and safety to workers would be greatly improved.

ACKNOWLEDGMENTS This paper is Contribution No. 02-125-13 of the Kansas State University Agricultural Experiment Station. Mention of product or trade name does not constitute an endorsement for its use by Kansas State University.

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47. FH Arthur. Impact of accumulated food on survival of Tribolium castaneum on concerete treated with cyﬂuthrin wettable powder. J Stored Prod Res 36:15–23, 2000. 48. FH Arthur. Impact of food source on survival of red ﬂour beetles and confused ﬂour beetles (Coleoptera: Tenebrionidae) exposed to diatomaceous earth. J Econ Entomol 93:1347–1356, 2000. 49. C Reed, F Arthur. Aeration. In: BH Subramanyam, DW Hagstrum, eds. Alternatives to Pesticides in Stored-Product IPM. Boston: Kluwer Academic Publishers, 2000, pp 51–72. 50. OSHA Title 29, Code of Federal Regulations, Standard Number 1910.1, Table Z-1: Limits for Air Contaminants. Washington, DC: U.S. Department of Labor, Occupational Safety and Health Administration, 2001. 51. FJ Wade, AL Hawk. Dust measurement inside grain conveying equipment. ASAE Paper No. 80-3560. St. Joseph, MI: American Society of Agricultural Engineers, 1980, pp 21. 52. KN Palmer. Dust Explosions and Fires. London: Chapman and Hall. 1973, p 396. 53. HD Wardlaw Jr, CB Parnell Jr, BJ Lesikar. Dust suppression results with mineral oil applications for corn and milo. Trans ASAE 32:1720–21726, 1989. 54. BJ Lesikar, CB Parnell Jr, A Garcia. Determination of grain dust explosibility parameters. Trans ASAE 34:571–576, 1991. 55. S Atallah. Fumigants and grain dust explosions. Fire Technology 15:5–9, 1979. 56. CB Parnell. Grain dust and grain dust explosions. Association of Operative Millers Bulletin, November, 1999, pp 7357–7361. 57. RW Schoeff. Preventing grain dust explosions. World Grain 10:8–9, 1992. 58. A Webb, SL Haley, L Leetmaa. Enhancing U.S. wheat export performance: the implications of wheat cleaning. Agribusiness 11:317–332, 1995. 59. DA Hennessy, TI Wahl. Discount schedules and grower incentives in grain marketing. Am J Agric Econ 79:888–901, 1997. 60. DD Johnson, WW Wilson. Evaluation of price-dockage strategies for U.S. wheat exporters. Rev Agri Econ 17:147–158, 1995. 61. HL Kiser, D Frey. Dockage treatment during the 1990 Kansas Wheat Harvest. Manhattan, KS: Kansas Agricultural Experiment Station, Contribution No 263, 1991, pp 1–17. 62. HL Kiser. Removing nonwheat material from Kansas wheat. Manhattan, KS: Kansas Agricultural Experiment Station, Contribution No 625, 1992, pp 1–27. 63. BT Hybert, M Ash, W Lin, C Lin, L Aldrich, D Pace. Economic implications of cleaning wheat in the United States. Washington DC: United States Department of Agriculture. Agricultural Economic Report No 669, 1993, p 57. 64. BH Subramanyam, DW Hagstrum. Resistance measurement and management. In: BH Subramanyam, DW Hagstrum, eds. Integrated Management of Insects in Stored Products. New York: Marcel Dekker, 1995, pp 352–362. 65. AV Barak, PK Harein. Losses associated with insect infestation of farm stored shelled corn and wheat in Minnesota. St. Paul, MN: University of Minnesota Agricultural Experiment Station Miscellaneous Publication 12, 1981, p 94. 66. LE Stephens, GH Foster. Grain bulk properties as affected by mechanical grain spreaders. Trans ASAE 19:354–358, 363, 1976. 67. M Verkade, P Chiotti. Literature survey of dust explosions in grain handling facilities: causes and prevention. Ames, IA: Energy and Minerals Resources Institute, Iowa State University, 1976. 68. CW Wrigley, LF Young, BA Baldo, A Basten, S Krilis. The allergenic and physical characteristics of grain dust as they affect the health of workers in the industry. Proceedings of the International Symposium on Grain Dust, Kansas State University, Manhattan, KS, 1979. 69. CB Parnell. Cyclone design for air pollution abatement associated with agricultural operations. Proceedings of the 1996 Beltwide Cotton Production Conference. National Cotton Council. Nashville, TN, 1996.

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70. V Mody, R Jakhete. Dust Control Handbook. New Jersey: Noyes Data Corporation, 1988, pp 63–69. 71. Food and Drug Administration. Food additives permitted for direct addition to food for human consumption: white mineral oil. Fed Reg 47:8763, 1982. 72. NDG White, DS Jayas, JT Mills, BL Dronzek. Effects of canola oil or white mineral oil at dust suppressant levels on the storage characteristics of wheat. Cereal Chem 69:182–187, 1992. 73. TL Mounts, K Warner, FS Lai, CR Martin, Y Pomeranz, WE Burkholder, AJ Peplinski, AR Class, CW Davis. Effect of laboratory-scale oil applications on quality factors of corn, soybeans, and wheat. Cereal Chem 65:175–181, 1988. 74. AJ Peplinski, RA Anderson, TL Mounts. Surface oil application effects on chemical, physical, and dry-milling properties of corn. Cereal Chem 67:232–236, 1990. 75. JB Cocke, HH Perkins Jr. NF Getchell. Controlling dusts in agricultural products with additives. Cereal Foods World 23:554–556, 1978. 76. FS Lai, CR Martin, BS Miller. Examining the use of additives to control dust in a commercial grain elevator, ASAE Paper No 84-3575. St. Joseph, MI: American Society of Agricultural Engineers, 1984, p 72. 77. DD Jones, CB Parnell Jr. Dust suppression characteristics of corn, wheat, and soybeans treated with mineral oil additives. ASAE Paper No. 85-3558, St. Joseph, MI: American Society of Agricultural Engineers, 1985, pp 35. 78. FH Hseih, JK Daun, KH Tipples. The effect of rapeseed oil added to control grain dust on the quality of wheat. JAOCS 59:11–15, 1982. 79. DS Jayas, NDG White, MG Britton, JT Mills. Effect of oil used for dust control on engineering properties of stored wheat. Trans ASAE 24:659–664, 1992.

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30 Sanitation and Safety for a Fats and Oils Processing Plant RICHARD D. O’BRIEN Fats and Oils Consultant, Plano, Texas, U.S.A.

I.

INTRODUCTION

Fats and oils have been recovered for thousands of years from oil-bearing seeds, nuts, beans, fruits, and animal tissues. These raw materials have been and continue to be important ingredients for foods, cosmetics, lubricants, and chemicals. The extracted fats and oils vary from pleasant smelling products that contain few impurities to very offensive smelling, highly impure materials. Fortunately, researchers have developed technologies for processing fats and oils products to make them more suitable for foods and other applications. Developments in lipid processing technology have produced ingredients that have been instrumental in the development of many of the current food products available that provide the functional and nutritional requirements of discerning and better-informed consumers. Processes have been developed to make them ﬂavorless, odorless, and lighter in color; modify their melting behavior; rearrange the molecular structure; remove potential disease-causing impurities; capture possible harmful materials, and effect other changes to make them more desirable for their intended applications. Process control is practiced during fats and oils processing to assure that safe, nutritious, pleasant, cost-effective products are produced that perform as intended. These products must meet all of the applicable legal requirements for a food product and customers’ standards of quality, performance, economics, and aesthetics. Each fat and oil’s process has individual critical control requirements that contribute to the quality assurance of the ﬁnished product. In practice, fats and oils critical control points fall into the areas of safety, quality, compliance, and economics. The hazard analysis and critical control points (HACCP) system, a part of the process control system, is a method that assesses and monitors food safety. © 2003 by Marcel Dekker, Inc.

The basic concept of HACCP can be stated by the maxim ‘‘an ounce of prevention is worth a pound of cure.’’ The HACCP system is based on the principle that food safety issues can be eliminated or minimized by prevention during production rather than by detection in the ﬁnished product. Development of a HACCP plan focuses on the identiﬁcation of critical points, along with procedures or activities that will adequately control them to ensure safe production of a food product. Food safety hazards include all microbiological, chemical, and foreign materials that, if consumed, could cause injury or harm [1]. II. EDIBLE FATS AND OILS COMPONENTS The primary constituents of extracted fats and oils by triglycerides, but they also contain varying amounts of nonglyceride materials. Some of the nonglyceride components are undesirable and can be considered a food safety hazard, while others are very beneﬁcial. Therefore, the objective in all of fats and oils processing is to remove the objectionable materials with the least possible damage to the desirable constituents. In most cases, free fatty acids, phospholipids, moisture, color pigments, oxidation products, waxes, trace metals, proteins, pesticides, meal, dirt, and other gross impurities are the materials that need to be removed. Most vegetable oils contain tocopherols, which are natural antioxidants that protect the oils from oxidation and should be retained. For some products, neither the color pigments nor waxes are detrimental and need not be removed. The major product quality concerns are with free fatty acids, phospholipids, oxidation products, proteins, and trace metals; all materials that affect the odor, ﬂavor, and ﬂavor stability of edible fats and oils products. In the United States, fats and oils color is usually a major concern in a cosmetic sense so pigment adsorption is a major impurities concern, especially for products marketed directly to consumers. The major food safety concerns are with residual pesticides, mold, bacteria, and impurities developed during processing or with mishandling. A.

Pesticides

Pesticides have been used for increased agriculture production throughout the world. Studies have shown that the majority of the pesticides applied eventually reach the soil surface where they gradually spread, translocate to other environments, or degrade. Translocation to oil-bearing plant seeds has also been demonstrated by studies. Processing studies have shown that neither solvent extraction nor bleaching affected the pesticide levels in vegetable oils. However, it was found that pesticides were removed by volatization during hydrogenation and/or deodorization [2–4]. United States government agencies have recognized that the insecticides are distilled from edible oils during the deodorization process and have forbidden the use of deodorizer distillates in animal feeds. B.

Mold and Bacteria

Moisture content is one of the most important factors in determining the storability of oil seeds, fruits, nuts, and animal fats. Both molds and bacteria have critical moisture levels for proliferation and enzymes function in an aqueous substrate. Microtoxins, or moldderived toxins, can infest oil seeds, nuts, and fruits that are routinely used as an oil source. Only a small portion of the toxin is retained in the separated oil received during normal processing. Filtration of the extracted oil lowers the aﬂatoxin level, and conventional reﬁning and bleaching effectively removes any residual aﬂatoxin [5]. © 2003 by Marcel Dekker, Inc.

C. In-Process Tank Impurities Storage tanks throughout the process are normally dedicated to a particular source oil or modiﬁed product. Even so these tanks are emptied and cleaned on a regular basis to remove the sludge which collects on the tank bottoms. This sludge is composed of polymerized oils, burnt particles, acid salts, high melting oil fractions and other impurities which develop and settle out of the oils during storage. Cleaning equipment using high-pressure jets rotating horizontally and vertically are effective in the large tanks ranging from 40,000- to million-pound capacities. High temperatures, in the range of 185°F (85°C), and an appropriate detergent suitable for use in food plants are used for washing before rinsing with clear water, and, ﬁnally, the tanks are sweetened with freshly processed oil. D. Separation of Impurities From the time that crude vegetable oils are expressed from the bean, nut, fruit, or seed, and meat fat rendered from the fatty tissues, until the ﬁnished oil product is packaged, edible fats and oils pass through clariﬁcation or ﬁltration steps in almost evey stage of the processing sequence. Even ﬁnished oils are subjected to a ﬁnal ﬁltration before packaging or loading into tank cars and trucks. The three generally used methods of separating impurities from oils are distillation, centrifugation, and ﬁltration. Pesticides and other impurities are removed from fats and oils with deodorization, which is a steam distillation process. Centrifuges are utilized to separate ﬁnes from solvent-extracted and screwpressed vegetable oils and to separate the saponiﬁed materials after caustic reﬁning and the gums participated with degumming processes. Filtration is employed as well as these processes and in all of the other major fats and oils processes to remove impurities. Filtration is the process of passing a ﬂuid through a permeable ﬁlter media in order to separate particles form the ﬂuid. The particles may be either in suspension or in solution. A ﬁlter medium is a porous material which allows a ﬂuid to pass through yet retain the particles to be removed. Examples of ﬁlter media are ﬁlter paper, ﬁlter cloth, and ﬁlter screens. Filters of various types are used throughout fats and oils processing beginning with clariﬁcation of the oils after extraction or rendering. Oils are ﬁltered after bleaching to remove the bleaching earth which has absorbed the color pigments and secondary oxidation products; after hydrogenation to remove the nickel catalyst which promoted the reaction; and after deodorization to remove minute quantities of burnt and polymerization particles which can develop during the high temperature process. Polish ﬁlters are utilized in the fats and oils process after movement of the product from one location to another to insure that any impurities developed during that particular process are removed immediately. III. PROCESSING FLOW SEQUENCE A HACCP process hazard analysis begins with a detailed examination and evaluation of the processing and handling facilities for the purpose of identifying the location and severity of food safety hazards. Hazard analysis begins with a current ﬂowchart of the production process, which provides a means to evaluate potential hazards. A complete HACCP analysis encompasses all processes from the ﬁeld to the ﬁnal consumer. This evaluation reviews each process or operation for situations that could result in adulteration with injurious materials, which fall into one or more of three categories, microbiological, foreign material, and chemical. After determining the location of potential hazards, the next step © 2003 by Marcel Dekker, Inc.

is to determine where critical control points exist. Critical control points are the positions in the process ﬂow where inadequate control would result in a contamination for which there are no downstream provisions to correct them. After the critical points are identiﬁed, it is essential to establish safe operating standards and monitoring procedures, frequencies, and responsibilities. Edible fats and oils processing involves a series of processes in which both physical and chemical changes are made to the raw material. Figure 1 illustrates most of the potential processing ﬂow sequencing to produe the various fats and oils products. The sanitaiton concerns for fats and oils processing plants are similar to those of any other food processor; for example; rodent, insect, and bird control; broken windows, leaking walls or roofs, unsecured doors, and screened doors; dirty ﬂoor drains; cracks in ﬂoors; etc. But, the risks are somewhat less since all of the processing is performed within closed systems. Many of these systems are protected from the atmosphere with vacuum, pressure, or nitrogen. Practically the only time that fats and oils products are exposed to the atmosphere is during ﬁlling into a package or a tanker for shipment. Therefore, the major product hazard concerns with fats and oils processing are the removal or impurities which have gained access to the product prior to processing, added as a processing aid, or developed during processing. Processing of fats and oils is initiated by an extraction or rendering process to remove the fat or oil from the seed, bean, nut, fruit, or fatty tissues. Vegetable oils processing after extraction almost always includes neutralization or reﬁning, bleaching, and deodorization, with the major differences being the choice of equipment and techniques utilized. Rendered animal fats are normally clariﬁed to remove impurities, bleached, and deodor-

Figure 1

Fats and oils processing ﬂow sequence.

© 2003 by Marcel Dekker, Inc.

ized, again with equipment and techniques selection providing the major differences. Clariﬁcation, neutralization, bleaching, and deodorization are all puriﬁcation processes which affect the ﬂavor, ﬂavor stability, and appearance of the fat or oil product while removing harmful impurities. Vegetable oils and animal fats are natural products with variable characteristics contributed by nature. The fats and oils products selected for a particular application are made on the basis of functionality. Each source oil or fat has characteristic functionality traits which can be modiﬁed with the hydrogenation, interesteriﬁcation, or fractionation processes. The natural or modiﬁed fats and oils products can also be blended to change the melting proﬁles, solidifation points, crystal tendencies, and other physical characteristics of the fats and oils ingredients. A review of the major fats and oils processes follows with an emphasis on the critical control points for food safety. A. Extraction Cleaning is the ﬁrst step in the processing of vegetable oils. Typically, oilseeds contain stems, pods, leaves, broken grain, dirt, sand, small stones, and other extraneous seeds. These foreign materials reduce the oil content, adversely affect oil quality, and increase the wear and damage potential to the extraction equipment. Shaker screens are used to separate the particles on the basis of size, whereas aspiration separates on the basis of density and buoyancy in a stream of air. Tramp iron, extraneous metal acquired during harvesting, storage, or transportation is removed to prevent damage to the equipment by the placement of magnets in chutes just ahead of vulnerable processing equipment. Extraction of oil from materials of plant origin is usually done by pressing, with the use of a continuous screw press or by extraction with volatile solvents. Prior to 1940, mechanical pressing was the primary method used. Mechanical pressing had limits because the oil recovery is poorer than with solvent extraction, and the high temperatures generated damaged both the oil and the meal. Solvent allows a more complete oil extraction at lower temperatures. Solvent extraction plants can be either batch or continuous. The continuous extraction plants can be percolation, immersion, or direct extraction plants. Generally, the oilseeds may be divided by oil content: above and below 20% oil content. In most cases, oilseeds with a low oil content are subjected to both continuous and batch solvent extraction. High oil content seeds are normally extracted in two stages—ﬁrst pressing and then solvent extraction—however, many single-step continuous direct solvent extraction systems are currently in use. To be used legally in the United States, oilseed extraction solvents and food processing substances must have been subjected to an approval by the U.S. Food and Drug Administration (FDA) or the U.S. Department of Agriculture (USDA), be generally recognized as safe (GRAS) for this use, or be used in accordance with food additives regulation promulgated by the U.S. FDA. Commercial hexane has been in major use since the 1940s, as an oilseed extraction solvent on the determination that it is GRAS, and it may also be subject to a prior sanction. Like many other food-processing substances, there is no U.S. FDA regulation speciﬁcally listing n-hexane as GRAS or having prior sanction. However, it has been cleared in as a solvent in a number of other food products, one of them a cocoa butter substitute with a 5 ppm maximum limit. Because edible fats and oils are subjected to deodorization and other puriﬁcation processes as a part of the manufacturing process before being used as a food product, they should not contain any of the extraction solvent, if proper practices are followed [6]. © 2003 by Marcel Dekker, Inc.

B.

Rendering

The fatty tissue from meat animals which is not a part of the carcass or that trimmed from the carcass in preparation for sale is the raw material from which lard and tallow is obtained. Separation of fat from the fatty tissues of animals is called rendering. The rendering process consists of two basic steps. First, the meat byproduct is heated to evaporate the moisture, to melt the fat present, and to condition the animal ﬁbrous tissue. Two alternative cooking temperatures are used: fat temperatures below 120°F and fat temperatures above 180°F. A more complete separation of the fat and protein is accomplished with the higher temperature processing, but a better quality protein is obtained with the lower temperature processing. Normally, the value of the protein dictates that the lower temperature, poorer separation technique be used, which probably leaves trace quantities of protein in the rendered lard or tallow. After cooking, the fat is separated from the solid proteinaceous material. In batch rendering the cooked material is allowed to separate and the fat to drain, followed by ﬁltration, to complete the separation. Continuous rendering, introduced to replace the batch systems, normally consists of a continuous cooker which requires less cooking time and is more energy efﬁcient with better quality control [7]. C.

Reﬁning Systems

Processors have the option of approaching edible oil puriﬁcation in two ways; either chemical or physical reﬁning. The two systems utilize very similar processes, with the major difference being the method used for free fatty acid removal. Chemical reﬁning, the conventional method used for removal of the nonglyceride impurities from edible fats and oils, consists of optional degumming, caustic neutralization, bleaching, and deodorization. The alkali reﬁning process produces good quality oil and is ﬂexible with the ability to treat different oils and different qualities of individual oils. However, caustic reﬁning has three major drawbacks: (1) the soap produced promotes a tendency for emulsion formation which will occlude neutral oil to increase oil losses, (2) oil losses are particularly high when processing oils with free fatty acids over 3.0%, and (3) disposal of the soapstock produced has become more difﬁcult. The second process, which has become known as physical reﬁning, consists of removing the fatty acids from the oil by steam distillation under vacuum after the phosphatides have been removed by a degumming process followed by a pretreatment process before bleaching. The major advantages for physical reﬁning are the elimination of soapstock, lower capital costs, and fewer processes to operate and maintain. The objective of the initial processing step in either reﬁning method is the removal of phosphatides, color bodies, and trace metals. Removal of these nontriglyceride impurities is crucial to ensure good product quality. Herein lies the major drawback for the physical reﬁning system; i.e., complete phosphatide removal with degumming and bleaching is very difﬁcult. Some of the other problems with physical reﬁning systems can be (1) additional bleaching earth usually required, (2) pesticides are codistilled with the fatty acids during steam reﬁning, (3) phosphoric acid treatment may darken the gums produced and incomplete removal can produce off ﬂavors in the oil after deodorization, (4) steam distillation or deodorizer units must be designed to handle higher concentrations of free fatty acids, (5) cottonseed oil cannot be physically reﬁned because the gossypol pigment must be removed with alkali reﬁning, and (6) it may be necessary to steam reﬁne before hydrogenation or other processing to adjust melting characteristics and deodorize again following these processes. Physical reﬁning is favored for processing high free acidity oils with low phosphatide © 2003 by Marcel Dekker, Inc.

contents; it has been demonstrated to produce good quality product from coconut, palm kernel, palm, lard, tallow, and some of the seed oils [8]. D. Degumming Degumming is the treatment of crude vegetable oils with water, salt solutions, or dilute acids such as phosphoric, citric, or maleic to remove phosphatides, waxes, and other impurities. Degumming converts the phosphatides to hydrated gums, which are insoluble in oil for separation as a slude by settling, ﬁltering, or centrifugal action. Phosphatide removal is the ﬁrst process for the physical reﬁning system and can also be for chemical reﬁning. However, with chemical reﬁning the processor has the option of removing the phosphatides for their byproduct value as lecithin or treating them as impurities to be removed along with free fatty acids during caustic neutralization. E.

Caustic Neutralization

The conventional caustic neutralization process is the most widely used and most well known puriﬁcation system. The addition of an alkali solution to a crude oil brings about a number of chemical and physical reactions: (1) the alkali combines with the free fatty acid present to form soaps, (2) the phosphatides absorb alkali and are coagulated through hydration, (3) pigments are degraded, absorbed by the gums, or made water soluble by the alkali, and (4) the insoluble matter is entrained with the other coagulable material. Efﬁcient separation of the soapstock from the neutralized oil is a signiﬁcant factor in caustic neutralization, which is usually accomplished with centrifugal separators. The conventional caustic soda neutralization systems have the ﬂexibility to efﬁciently reﬁne all of the crude oils presently utilized for food products [9]. Caustic neutralization is ordinarily accomplished by treating the fat or oil with diluted sodium hydroxide. This treatment forms soapstock with the free fatty acids, phosphatides, trace metals, pigments, and other nonglyceride impurities that can be separated by settling or centrifugal force from the neutralized oil. The neutral oil is usually water washed and again separated by settling or centrifuged to remove trace impurities and residual soaps from the neutralization and separation processes. After water washing, the oil is either dried with a vacuum dryer or immediately bleached to remove the trace quantities of water remaining. F.

Bleaching

Edible fats and oils bleaching is popularly and correctly regarded as the partial or complete removal of color; however, bleaching is also an integral process in both the chemical and physical reﬁning systems. Bleaching is relied upon to clean up the traces of soap and phosphatides remaining after caustic neutralization and water washing for the chemical reﬁning system. For physical reﬁning, the technical feasibility depends upon bleaching as a pretreatment to remove phosphatides, trace metals, waxes, and the color pigments. Another, very important function of bleaching, in both reﬁning systems, is the removal of peroxides and secondary oxidation products. The usual method of bleaching is by adsorption of the pigments and other nonglyceride impurities on bleaching earth. In a typical process, the bleaching materials are added to the oil in an agitated vessel either at atmospheric pressure or under a vacuum. The oil is heated to bleaching temperature and held to allow contact time with the bleaching earth. © 2003 by Marcel Dekker, Inc.

After the adsorbent has captured the color pigments, soap, phosphatides, trace metals, and polar materials, it becomes an impurity which must be removed from the oil with a ﬁltration system. Control point impurities analyses are used to monitor the removal of the potential food safety hazard. G.

Animal Fat Puriﬁcation Systems

Traditionally, the method used to purify meat fats has been a form of physical reﬁning. The two main impurities in meat fats are proteins carried over from the rendering process and free fatty acids. The pretreatment phase for meat fats is the removal of the proteinaceous materials. Typically this is easily accomplished by adding small amounts of diatomaceous earth and/or bleaching earth followed by ﬁltration. An alternative clariﬁcation or pretreatment method is to water wash the fat to remove the proteins. This method also requires bleaching or at least drying to remove the moisture remaining in the oil after water washing. A third method for meat fat clariﬁcation is caustic reﬁning. Chemical reﬁning is usually reserved for poor quality animal fats or for specialty products used undeodorized to preserve the characteristic meat fat ﬂavor. The caustic reﬁning system consists of caustic neutralization, water washing, and vacuum drying. H.

Hydrogenation

The hydrogenation process is an important tool for the edible fats and oils processor. With hydrogenation, liquid oils can be converted into plastic or hard fats more suitable for a particular food product. There are two reasons to hydrogenate a fat or oil: (1) to change the physical form for product functionality improvement and (2) to improve oxidative stability. Hydrogenation involves the chemical addition of hydrogen to the double bonds in the unsaturated fatty acids. The reaction is carried out by mixing heated oil and hydrogen gas in the presence of a catalyst. After the hyhdrogenation end point has been achieved, the hardened oil is cooled and ﬁltered to remove the nickel catalyst. Most hydrogenations are preformed in batch reactors due to the variation in raw materials and the desired end products. Normally, batch hydrogenation is performed in an agitated tank reactor with heating and cooling capabilities designed to withstand pressures of 7 to 10 bar. First, the catalyst is suspended in the oil. Then, hydrogen gas, dispersed as bubbles, must be dissolved in the oil to reach the surface of the catalyst. The three reaction variables, pressure, temperature, and rate of agitation, are controlled to reduce batch-to-batch variation for preparation of the desired hydrogenated product or basestock. The typical analytical evaluations for endpoint control which measure consistency are refractive index, iodine value, and various melting points. A food safety control point would be the incomplete removal of the nickel catalyst after the reaction is completed; however, this is not a critical control point because the postbleaching process immediately following hydrogenation is designed to remove any remaining trace catalyst impurities. I.

Postbleaching

A separate bleaching operation, immediately following the hydrogenation process, has three purposes: (1) insurance that all traces of the prooxidant hydrogenation catalyst that has escaped the ﬁltration system after hydrogenation have been removed, (2) to remove undesirable colors generally of a greenish hue accentuated during hydrogenation by heat © 2003 by Marcel Dekker, Inc.

bleaching of the red and yellow pigments, and (3) removal of peroxide and secondary oxidation products. Postbleach systems are usually batch systems for the same reason as for hydrogenation systems, production of a wide variety of hydrogenated basestocks. J. Fractionation Edible fats and oils are fractionated to provide new materials more useful than the natural product. Fractionation may be practiced to remove an undesirable component, which is the case with dewaxing and winterization, or to provide two or more functional products from the same original fat or oil as is the case with cocoa butter equivalents or substitutes and high stability oils. The three fractionation process types practiced commercially to produce the value added products are (1) dry fractionation, (2) solvent fractionation, and (3) aqueous detergent fractionation. Dry fractionation, which includes winterization, dewaxing, hydraulic pressing, and crystal fractionation processes, is probably the most widely practiced. Solvent or aqueous detergent fractionation processes provide better separation of speciﬁc fractions for the most sophisticated fats and oils products. All of these fractionation processes practice the three successive stages of fractionation: (1) cooling the oil to supersaturation to form the nuclei for crystallization, (2) progressive growth of the crystalline and liquid phases, and (3) separation of the crystalline and liquid fractions. A food safety control point identiﬁed for the solvent fractionation system would naturally be removal of the solvent used. Complete solvent removal is assured with steam distillation in the deodorization process which is downstream. K. Interesteriﬁcation The interesteriﬁcation process can alter the original order of distribution of the fatty acids in the triglyeride-producing products with melting and crystallization characteristics different from the original oil or fat. Unlike hydrogenation, interesteriﬁcation neither affects the degree of saturation nor causes isomerization of the fatty acid double bond. It does not change the fatty acid composition of the starting material but rearranges the fatty avids on the glycerol molecule. The process of interesteriﬁcation can be considered as the removal of fatty acids from the glyceride molecules, then shufﬂing and replacing them on the glyceride molecules at random. This change in the distribution of the fatty acids affects the structural properties and melting behavior of the fats and oils. Commercially, the interesteriﬁcation process has been utilized for the production of confectionery fats, margarine oils, cooking oils, frying fats, shortenings, and other special application fats and oils products. Two types of chemical interesteriﬁcation process are practiced: random and directed. Random rearrangement of fats and oils can be accomplished using either a batch or continuous process. Both random interesteriﬁcation processes perform the three important rearrangement steps: (1) pretreatment of the oil, (2) reaction with the catalyst, and (3) deactivation of the catalyst. In the directed rearrangement process, one or more of the triglyceride products of the interesteriﬁcation reaction is selectively removed from the ongoing reaction. Continuous processes are normally used for directed rearrangements for better control. Trisaturated glyerides are crystallized and separated from the reaction, which upsets the reaction equilibrium so that more trisaturated glycerides are produced. © 2003 by Marcel Dekker, Inc.

L.

Blending

Different stocks are blended to produce the speciﬁed composition, consistency, and stability requirements for the various fats and oils products, such as shortenings, frying fats, margarine oils, specialty products, and even some salad or cooking oils. The basestocks may be composed of hydrogenated fats and oils, interesteriﬁed products, reﬁned and bleached vegetable oils, puriﬁed animal fats, and/or fractions from winterization, dewaxing, or another form of fractionation. The products are blended to meet both the composition and analytical consistency controls identiﬁed by the product developers and quality assurance. The consistency controls frequently include analytical testing for solids fat index, iodine value, various melting points, fatty acid composition, and other evaluations designed to ensure compliance with customer requirements. The blending process requires scale tanks and meters to proportion the basestocks accurately for each different product. The blend tanks should be equipped with agitators and heating to assure a uniform blend for consistency control [9]. M. Deodorization With conventional edible oil processing, deodorization is the last in a series of process steps used to improve the taste, odor, stability, and the food safety of the fats and oils by the removal of undesirable substances. In this process, the fats and oils products are steam distilled under vacuum. The object is to remove the volatile impurities from the oil. The foremost concern from a quality aspect is the volatile impurities removal, which are the objectionable ﬂavors and odors; however, deodorization is also very important from a food safety aspect. Steam distillation removes any trace pesticide and heavy metals content obtained during the growing process. Deodorization is primarily a high-temperature, highvacuum, steam distillation process to remove volatile, odoriferous materials present in edible fats and oils. It is the last major processing step through which the ﬂavor and odor and many of the stability qualities of a fat or oil product can be changed. From this point forward, efforts must be directed toward retaining the quality that has been built into the fat and oil product with all of the preceding processes [9]. The odoriferous substances in fats and oils are generally considered to be free fatty acids, peroxides, aldehydes, ketones, alcohols, and other organic compounds. Experience has shown that the removal of ﬂavor, odor, and other undesirables correlates well with the reduction of free fatty acids. Therefore, all commercial deodorization consists of steam stripping the oil for free fatty removal. Currently, batch, semicontinuous, and continuous systems of various designs are utilized by edible fats and oils processors to produce deodorized oil. All of the systems utilize steam stripping with four interrelated operating variables: vacuum, temperature, stripping steam rate, and holding time. N.

Liquid Oil Filling and Packaging

Most salad and cooking oils are packaged shortly after deodorization in containers for home, restaurant, or large food processor use. The processing necessary for most oils is oxidative stability preservation measures such as nitrogen protection, temperature control, light avoidance, and the addition of any additives required by the individual products. The oil is ﬁltered for a ﬁnal time in-line to the bottle ﬁller. The effectiveness of this ﬁnal ﬁltration is monitored with laboratory ﬁlterable impurities testing of packaged product samples obtained utilizing a statistical sampling plan. Food safety concerns for retail liquid © 2003 by Marcel Dekker, Inc.

oil were lessened with the packaging change from glass to plastic containers. Glass breakage and contamination of other containers were major concerns when glass bottles were used. Exposure of the oil to the atmopshere is limited to a microsecond for most ﬁlling lines with a temper-evident seal applied to the container before the cap is applied. O.

Shortening Plasticization and Packaging

Plasticized shortening products can be deﬁned as fats with a consistency that can be readily spread, mixed, or worked. Considerably more is involved in the plasticization of shortening and margarine than merely lowering the temperature to cause solidiﬁcation. Slow cooling of these products produces a grainy, pasty, nonuniform mushy product that lacks the appearance, texture, and functional characteristics associated with plasticized products. Development of these characteristics is a function of controlled crystallization or plasticization. The ﬁnal consistency of a shortening is the culmination of all the factors inﬂuencing crystallization and plasticization: chilling, working, tempering, pressure, and gas incorporation. The plasticization process involves the rapid chilling and homogenization of shortening mixture. Most shortenings are quick chilled in closed thin-ﬁlm scraped-wall heat exchangers with extrusion valves to deliver a smooth homogeneous product to the package at 17 to 27 atm pressure. Nitrogen is injected at 13 ⫾ 1% into most shortenings to increase the product’s workability and provide a white, creamy appearance. After packaging, many processors temper shortenings at temperatures slightly above the packaging temperature to allow the crystal structure of the hard fraction to reach equilibrium and form a stable matrix. After tempering, shortenings are usually stored and shipped at controlled temperatures of 70 to 80°F (21.1 to 26.7°C) to avoid crystal change and loss of the plastic properties [10]. Shortenings are only exposed to the atmosphere during the actual ﬁlling of the product into the container, which is less than 15 sec for the slowest ﬁlling lines. Protection from contamination from the atmosphere is provided at the ﬁlling lines with covers and other protective devices. As in most of the other fats and oils processes the oil is ﬁltered for a ﬁnal time while being pumped to the plasticization equipment. Laboratory ﬁlterable impurities testing of the packaged product will determine if this ﬁltration effectively removed any particles of polymerized or charred oil that may have developed during storage or movement to the shortening ﬁlling department. A positive ﬁnding at this point is only resolved by reworking the packaged product involved. This necessitates a remelting of the product reprocessing that may include bleaching and deodorization. Shortenings free of impurities and that meet all of the other quality requirements are released for shipment after the product has crystallized to the predetermined consistency. Plasticization provides a safety risk that requires careful control: metal contamination from the plasticization equipment. The scraped wall heat exchangers have very tight tolerances between the ﬂoating metal scraper blades and the chilling surface. A malfunction of this equipment can distribute shreds of metal into the product. Protective devices such as magnetic traps downstream of the plasticization equipment, screens to ﬁlter the product, and metal detection after packaging is used on almost all shortening and margarine packaging lines. The magnetic traps and the screens need to be inspected on a routine basis, probably daily, to insure that no problems have developed since the last inspection. Metal particle ﬁndings necessitate a hold on the release of the product ﬁlled on that particular line during the period covered by the last inspection. Packaged product metal detectors © 2003 by Marcel Dekker, Inc.

usually isolate the package with a positive detection. Inspection of these packages must include the package itself because the detection levels must be set to very sensitive levels. At these levels the equipment will alarm with the tramp metal contained in many packages. The package metal detectors should be tested hourly with a test wand or package with metal contents at the lowest detection level. P.

Margarine Mixing, Chilling, and Packaging

Margarine was developed and continues to be a butter substitute. It is a ﬂavored food product containing 80% fat, made by blending selected fats and oils with other ingredients, such as milk, salt, and colors, and fortiﬁed with vitamin A to produce a table, cooking, or baking fat product that serves the purpose of dairy butter but is different in composition and can be varied for different applications. Now spreads have been developed as margarine substitutes. The major difference between spreads and margarine is that spreads are not required to contain a minimum of 80% fat. Processing for margarines and spreads begins with the preparation of an emulsion of the ingredients. Emulsions are prepared by adding the oil soluble ingredients to heated margarine oil formulations in an agitated emulsion tank. Concurrently, a pasteurized aqueous phase is prepared by mixing all of the water-soluble ingredients together in another vat. The water phase is then added to the oil phase to make the emulsion. The emulsion is rapidly chilled with scraped wall heat exchangers similar to those used for shortening products. The plasticized products are then formed into prints, or ﬁlled into the various containers for consumer, restaurant, or food processor use. Most margarine and spread products are stored at refrigerator temperatures immediately after packaging, except for some specialized baking products [9]. The high moisture content with or without milk makes margarine and spreads a good growth media for microorganisms. Bacteria need food, moisture, and heat to grow. They are not mobile and have to be transported from place to place, most often by hands, shoes, and clothes. Therefore, the ﬁrst preventive measures to practice are the good manufacturing practices (GMPs). The generic ﬁrst area for any HACCP program for all areas of the plant, but with special attention in the margarine areas, is employee hygiene to prevent the spreading of human bacteria like E. coli. The equipment must be kept clean and sanitized to prevent the growth of microorganisms. Normally, margarine processing equipment are cleaned and sanitized with clean-in-place (CIP) systems. In many plants, a highly acidic solution may be held in the equipment and lines during down periods to discourage bacterial growth. Additionally, any suspect ingredient should be pasteurized before use. Many margarine producers will pasteurize the water phase of the margarine or spread emulsions using continuous in-line high-temperature/short-time (HTST) pasteurization techniques. Formulation-wise, it is desirable to add preservatives to the product, where permitted. After packaging, margarine and spread products are stored, shipped, and displayed in the grocery stores under refrigeration. The product safety preventive measures are followed up with testing for harmful microorganism contamination. The types of bacteria that most margarine manufactures check for are [9] Coliform. Some members of the coliform group are found in the intestines of all warm blooded animals. They are not generally considered pathogenic or disease producing but rather as ‘‘fellow travelers’’ with intestinal pathogens. Coliforms do not survive pasteurization. When found in pasteurized product, their presence © 2003 by Marcel Dekker, Inc.

is suggestive or unsanitary conditions or practices during production, packaging, or storage. Coliform testing measures the quality of the sanitation procedures. Standard Plate Count. Total plate count is valuable as a sanitation indicator and for quality information. The bacteria that grow at the total plate count incubation temperature are known as mesophiles and include a wide variety of microorganisms. The media used is nutrient rich and nonselective. Both pathogenic and nonpathogenic organisms may be present. Yeast and Mold. Yeast and mold have very similar growth parameters. Both are able to survive extremes in conditions, such as pH, water activity, and high concentrations of sugar, that most bacteria cannot tolerate. Since yeast and mold can survive such conditions, they are important spoilage organisms in margarine and spread products. The presence of yeast and mold in these products indicates poor sanitation practices. Thermophile. The term thermophile is used to describe a group of microorganisms that grow in the 131 to 194°F (55° to 90°C) range. These organisms are very heat sensitive and can cause spoilage of product. They will grow into spores if held at elevated temperatures or if the product is improperly cooled. Pathogenic Microorganisms. A pathogen is an organism that causes disease. The two types that are of interest for margarine and spread products are infections and intoxications. Salmonella, E. coliform, and Listeria are infectious organisms that can grow in margarine-type products. These live organisms are poisonous to humans and cause food poisoning when they are ingested. The other organism that pose a problem is Staphylococcus. Some strains of Staphylococcus produce a toxin that is poisonous to humans when ingested. Pasteurization will kill the organism, but once the toxin has been formed it remains active. This is the reason hand contamination of product after pasteurization can have very critical effects. Q.

Flaking and Spray Chilling

Fat ﬂakes describe the higher melting fat and oil products solidiﬁed in a thin ﬂake form for ease of handling, quick remelting, or for a speciﬁc function in a good product. Chill rolls and processed oil formulations have been adapted to produce several different ﬂaked products that can provide distinctive performance characteristics in specialty formulated foods. The ﬂaked products, produced almost exclusively for the restaurant and food processor consumers, are hardfats or stearines, shortening chips, icing stabilizers, confectioner fats, hard emulsiﬁers, and other customer-speciﬁc products. The ﬂake products are solidiﬁed on a chill roll, which has been described as an endless moving chilling surface, held at a temperature below the crystallization point of the applied fat or oil product to form a congealed ﬁlm on the outer surface. Speciﬁcally, chill rolls are usually 4-ft diameter hollow metal cylinders, in various lengths, with a machined and ground smooth surface, internally refrigerated, that revolve slowly on longitudinal and horizontal axes, with several options for feeding the melted oil onto the surface. After application, a thin ﬁlm of liquid fat is carried over the roll, and as the revolution of the roll continues the fat is partially solidiﬁed. The solidiﬁed fat is scraped from the roll by a doctor blade positioned ahead of the feeding mechanism with all of the chill roll designs. Flakes are packaged in kraft bags, corrugated cartons with vinyl liners, or other suitable containers for storage and shipment [10]. Spray-chilled or powdered fats are specialized products developed for ease of incor© 2003 by Marcel Dekker, Inc.

poration, handling, melting efﬁciency, uniform delivery with addition systems, encapsulation, and other special purpose uses. The spray-chilling process consists of atomizing a molten fat in a crystallization zone or tower, maintained under temperature conditions where a very ﬁne mist of the melted fat is contacted with cooled air or gas to cause crystallization without marked supercooling [9]. Flaked products present the most opportunity for product contamination during processing of all the fats and oils products. During chilling the product is exposed to the atmosphere longer than any of the other packaging operations. Most chill rolls are protected from airborne contamination with shields, but the chill time and slow packaging rate require constant attention by the packaging employees. Metal contamination is also a product risk with some of the chill roll arrangements using application rolls or metal doctor blades. Metal detection after packaging and constant visual attention by the packaging employee have effectively identiﬁed any problems. Nevertheless, the preventive measures are proper equipment maintenance, proper equipment set-up, and diligent inspection of the equipment. R.

Bulk Fats and Oils Shipments

Food processors that use fats and oils in large quantities many times have the facilities to handle this ingredient liquid in bulk. All of the products packaged for shipment and use can be provided to the customers in tank cars or tank trucks, except margarine and spread mixes which contain milk and salt. The customers for these bulk products must have fats and oils bulk handling systems to receive, store, and handle the liquid products. Impurities and contamination are the two major food safety concerns which are controlled with a thorough inspection of the cleanliness of the tankers and inline ﬁltration of the oil during loading. Oil purity is monitored with laboratory ﬁlterable impurities evaluations of representative sample obtained from the tanker after loading. An impurity deviation at this point necessitates unloading of the tanker and reprocessing to remove the impurity identiﬁed. In addition, it is standard practice for the bulk oil customer to again ﬁlter the oil as it is being unloaded into his facility.

REFERENCES 1. R Vail. Fundamentals of HACCP. Cereal Foods World 39(5):393–395, 1994. 2. KJ Smith, PB Polen, DM DeVries, FB Coon. Removal of chlorinated pesticides from crude vegetable oils by simulated commercial processing procedures. J Am Oil Chem Soc 45(9): 866–869, 1968. 3. TL Mounts, CD Evans, HJ Dutton, JC Cowan. Some radiochemical experiments on minor constituents in soybean oil. J Am Oil Chem Soc 46(9):472–484, 1969. 4. MM Chaudry, AI Nelson, EG Perkins. Distribution of aldrin and dieldrin in soybeans, oil, and by-products during processing. J Am Oil Chem Soc 53(11):695–697, 1976. 5. WA Parker, D Melnick. Absence of aﬂatoxin from reﬁned vegetable oils, J Am Oil Chem Soc 43(11):635–638, 1966. 6. PJ Wakelyn. Regulatory considerations for oilseed processors and oil reﬁners. In: P Wan et al., eds. Introduction to Fats and Oils Technology, 2nd Ed. Champaign, IL: AOCS Press, 2000, pp 319–321. 7. WH Prokop. Rendering systems for processing animal by-product materials. J Am Oil Chem Soc 62(4):805–811, 1985. 8. FVK Young. Physical reﬁning. In DR Erickson, ed. Edible Fats and Oils Processing: Basic

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Principles and Modern Practices: World Conference Proceedings, Champaign, IL: American Oil Chemists Society, 1990, pp 124–135. 9. RD O’Brien. Fats and Oils Formulating and Processing for Applications. Lancaster, PA: Technomic Publishing Co., 1998, pp 1–4, 47–54, 129–131, 168–175, 182–183, 251–253, 258– 260, 264–266, 483, 525, 652–653. 10. RD O’Brien. Soybean oil crystallization and fractionation. In: DR Erickson, ed. Practical Handbook of Soybean Processing and Utilization. Champaign, IL: AOCS Press and United Soybean Board, 1995, pp 260–264.

© 2003 by Marcel Dekker, Inc.

31 Poultry Processing, Product Sanitation, and HACCP T. C. CHEN Mississippi State University, Mississippi State, Mississippi, U.S.A. PING-LIEH THOMAS WANG Fieldale Farms Corporation, Baldwin, Georgia, U.S.A.

I.

TRENDS IN POULTRY MEAT CONSUMPTION

Poultry is one of the world’s fastest growing meat sources. Poultry includes mainly broilers, other chickens, turkeys, ducks, and geese; however, broilers account for nearly 70% of the total. This growth in the world poultry market has resulted from increased income and demand. Between 1970 and 1990, developing countries boosted poultry output nearly four times, which resulted in an increase of the world poultry meat share from 25 to 36%. During the past 25 years, there has been a 200% rise in total world poultry meat consumption. The number is especially signiﬁcant in comparison with a rise of only 73% for red meat consumption. The major reason for this increase is the lower price of poultry in comparison with that of red meat. Other factors include changes in food habits and dietary considerations that highlight the low fat content of poultry. In 1992, nutrition was chosen as the number one factor in the purchase of chicken by consumers, and price came in second. The largest poultry meat producing country in the world is the United States. Efﬁciencies attainable from technology have changed the U.S. poultry industry. Through integration, consolidation (larger and fewer ﬁrms), shortening the production cycle, and concentrating production in fewer states, the U.S. poultry industry has experienced a larger and growing domestic market. Per capita poultry consumption moved past the pork sector

© 2003 by Marcel Dekker, Inc.

Table 1 Per Capita Consumption of Muscle Foods in the United States, in Pounds Year

Beef

Pork

Chicken a

Turkey a

Seafood

1960 1965 1970 1975 1980 1985 1990 1995 2000

59.1 70.4 79.6 83.0 72.1 74.6 63.9 63.6 64.5

48.6 43.6 48.1 38.3 52.1 47.7 46.4 48.4 47.7

19.2 22.9 27.4 26.4 32.7 36.4 42.4 48.2 52.9

4.9 6.0 6.4 6.5 8.1 9.1 13.8 13.9 13.7

10.3 10.9 11.7 12.1 12.4 15.0 15.0 14.8 15.2

Source: ERS, U.S. Department of Agriculture. a Boneless edible weight.

in 1985 and passed the beef sector in 1989. Today, poultry meat is the number one meat in the United States, with a per capita yearly consumption of 94.7 lb (Table 1). Marketing of poultry products has truly been one of the keys to success of the poultry industry in the United States. The combination of more healthful image, competitive price, and most recently the development of further-processed products has been largely responsible for the rapid growth in poultry consumption. Fast-food cutlets now offer poultry items such as chicken nuggets, ﬁllets, tenders, etc. Families can now buy cut-up parts for convenience; thereby avoiding wasted leftovers. Many of the U.S. broiler companies have aimed their marketing strategies at providing the products needed by the fast-food chains and have been successful with that approach. The increasing popularity of deboned breast meat led poultry companies to further segment the market through bird weights. Companies started growing heavier birds for deboning since the amount of labor to process a small breast was nearly the same as for a large breast, and therefore the labor cost per pound was less for the larger breast. II. POULTRY PROCESSING TECHNOLOGY The technology of the poultry meat industry differs from red meat industries. Poultry processing refers to slaughtering, feather removal, and evisceration. Historically, the most important development in the processing industry was the invention of the rubber picking ﬁnger. By the mid-1940s, rubber ﬁngered picking machines were perfected and much of the hand labor formerly used for pinning carcasses was eliminated. Mandatory poultry inspection also helped the progress of the poultry processing industry. To meet inspection requirements, many plants had to modernize their facilities and adopt strict quality control programs. As broiler meat dominates poultry meat, broiler processing steps will be considered as the normal procedure. The following are the abridged processing procedures [1–3]: 1. Live bird pick-up and hauling. Whenever possible, live birds or broilers are caught at night for loading. At that time they are easier to catch, struggle less, and settle down in the coops faster, and especially in the summer, the weather is cooler at night. The normal procedure in the broiler house is to raise the feeders and waterers above the © 2003 by Marcel Dekker, Inc.

reach of the birds at least 1–4 hr prior to the arrival of the live haul crew. The optimal withdrawal time for feed and water is about 10–12 hr. Live bird shrinkage can range from 0.3 to 0.5% per hour over a 24-hr period. Minimizing bruises on the carcass and allowing sufﬁcient time to clear the digestive tract are the major concerns during live bird pick-up and hauling. 2. Receiving and holding. Truckloads of live birds are held in a holding shed at the processing plant while awaiting unloading. Adequate ventilation is necessary to prevent live birds from dying of heat prostration. 3. Hanging on the kill line. In removing birds from crates, bruises and broken bones must be avoided. The hanging of all poultry on shackles should be done in a manner to minimize struggling of the birds. Birds that struggle excessively, as evidenced by wild wing ﬂapping, can bruise their wings as well as birds adjacent to them. 4. Humane slaughter. In the United States, the law requires that all animals be stunned prior to slaughter. The method of choice in the poultry industry is electrical stunning. The killing operation can be performed either manually or mechanically. ‘‘Modiﬁed kosher’’ killed birds are those with the jugular veins severed just below the jowls so that the windpipe and esophagus remain uncut. The longer the bleeding time, the more blood removed and the fewer downgraded birds. Most processors allow from 90 to 180 sec for bleeding prior to scalding. Electrical stunning is the most widely accepted method for immobilizing poultry prior to slaughter. Development and implementation of low voltage stunning systems (10 to 14 V, pulsed direct current, 500 Hz, 10–12 mA per bird) for broilers has been well received by the industry. When too high an amperage is used, the wing tips are often pink in color. Breast rub pads are used to calm the birds from live-hanging through the stunning. The metal grate at the bottom of the stunner cabinet is immersed roughly 1 cm in 1% NaCl solution. Ground bars are attached to assure the ﬂow of current. 5. Scalding. Bird feather release is attained by immersing the birds in hot water. A surge agitation–type tank is generally used, with the carcasses conveyed through hot water. The scalding procedure requires close attention to both time and temperature. Adequate heat must be applied to effect the relaxation of muscles in feather follicles. Depending on the water temperature, there are several scalding conditions: soft-(122°F, or 50°C), semi-(125–130°F, or 51.7–54.4°C), sub-(138–140°F, or 58.9–60°C), and hardscalding (⬎145°F, or 62.8°C). For a semi-scald operation, a temperature of 125 to 130°F (51.7 to 54.4°C) is used and the scald time varies from 1.5 to 2.5 min, depending on the scalding temperature. Scalding carcasses in the range between 130–138°F (54.4–58.9°C) should be avoided because the temperature is too hot to keep all the skin intact and too low to remove all the epidermal layer of skin. Many processing plants scald broilers at 138–139°F (58.9–59.4°C) for 140–150 sec. The force required to remove feathers from the carcass decreases as the scalding temperature increases. Scalding procedures have a direct effect on appearance of the defeathered carcass and tenderness of surface muscles. From the sanitation standpoint, counterﬂow multistage scalding is the solution to improve the hygiene of the scalding operation. Recently, a new scalding system has been developed. In a completely enclosed environment, the carcasses are showered with hot water and then conveyed through humidity cabinets where they are sprayed with steam at 140°F (60°C). The noise and odor levels are greatly reduced for this operation. 6. Defeathering. After the carcasses leave the scalder, they enter a series of defeathering machines such as ‘‘roughers’’ or ‘‘pickers,’’ each with a specialized purpose. © 2003 by Marcel Dekker, Inc.

The total time of the entire defeathering operation is about 30 sec. Feather removal is achieved by rotating rubber ﬁngers beating on the body surface to rub the feather free of the follicles. For some processors, after defeathering the carcasses pass through a pinning, singeing, and bird washing area. Adequate feather removal is essential for the acceptable carcass appearance. 7. Head removal. The head-removal operation may take place in the defeathering area. The bird’s neck passes through a V-shaped device to separate the head as the body is pulled forward by the overhead conveyer. 8. Hock cutting and bird transfer. After passing the bird washer, the carcasses are moved through a hock cutter that separates the shanks at the hock joint and the carcasses drop onto a conveyor for transfer to the evisceration area. Scalding and defeathering are conﬁned to a room separate from the others because of high noise levels, humidity, and sanitation consideration. 9. Evisceration and inspection. The carcasses are eviscerated by removing the shanks, head, preen gland, viscera, crop, and lungs from the defeathered carcasses. The evisceration operation also includes the harvesting of giblets. Defeathered carcasses are hung on the evisceration line. The usual positioning of poultry on this line is by hanging the feet in shackles. In plants equipped with mechanical eviscerating equipment, only the two-point suspension is used. An incision is made through the abdominal wall under the tail. The cut is continued around the vent so that intestines are free of any connection to the skin or abdominal wall muscle. All organs of the body cavity are removed through this opening. After the abdomen is open and partially cleared of intestinal organs, an employee from the U.S. Department of Agriculture (USDA) inspects each carcass for wholesomeness. The inspector examines both the outside and inside of the carcass and the viscera. A trimmer removes parts with broken bones, bruised tissue, breast blisters, improperly trimmed shanks, or others that have been determined to be unwholesome by the inspector. When the carcass is passed by the inspector, the giblets are harvested and cleaned and the carcass is given a thorough washing, inside and outside, to remove blood clots or other foreign material. In the United States, typically each dressing line supplies carcasses for two evisceration lines. Depending upon the inspection system used, evisceration line speeds are limited to either 70 or 91 birds per minute for the Streamlined Inspection System (SIS) or New Enhanced Line Speeds (NELS) system, respectively. 10. Washing and chilling. Chilling poultry carcasses is essential for control of microbial growth. Poultry carcasses can be chilled in cold running tap water, crushed ice, slush ice, slush ice agitated with compressed air, or a circulating pump. According to USDA regulations, carcasses must be chilled to at least 40°F (4.4°C) internal temperature. In addition, the chiller overﬂow rate must be maintained at one-half gallon of water per bird chilled in order to minimize the microbial build-up in the chilling water. The carcasses are dropped from the evisceration line into a prechiller, which also serves as an effective washer. A second chiller is in line and has a water temperature of less than 35.6°F (2°C). As cooling the product takes time, the onset and resolution of rigor mortis may occur during the chilling process. The chilled carcasses are ready for packaging or cutting into parts prior to the packaging. The amount of moisture pick-up allowed during chilling varies with the class of poultry and with the product disposition. Maximum pick-up allowed for broilers going directly to consumers is 8%; whereas broilers to be shipped and rehandled in a distant © 2003 by Marcel Dekker, Inc.

market are allowed 12%. After chilling, the carcasses are hung on a drip line and conveyed to the packaging area. The carcasses are allowed 2.5 to 4 min to drain the excess moisture. 11. Grading. In some plants, carcass grading is done next to the exit point of the chiller. In others, it may be performed at various points before the birds reach the giblet stufﬁng station of sizing bins. Grading identiﬁcation is based on either plant or USDA grade. Training and supervision of graders are under the direction of a federal grader. Grade factors for ready-to-cook broiler carcasses include conformation, ﬂeshing, fat covering, defeathering (pin and hair feather), exposed ﬂesh, discoloration, disjointed and broken bones, missing parts, and freezing defects. 12. Packaging. The majority of chilled poultry is packaged as whole carcasses, parts, or deboned or ground products at the processing plant. The individual package is weighed, priced and printed with the store’s label and bar code for automated check out. The packaged poultry is placed in cardboard boxes and delivered to the warehouse for redistribution. On January 26, 2000, all the poultry processing plants, regardless of size, in the United States were required to implement a pathogen reduction/hazard analysis and critical control point (HACCP) plan. All HACCP plans must address zero tolerance for fecal material, or ‘‘zero fecal.’’ This means that there must be no fecal material present on the carcass before the carcass enters a chiller. The two most common ways for plants to increase compliance with the regulations are through increased bird washing and the use of antimicrobials such as chlorine and trisodium phosphate (TSP). Different combinations of inside/outside washer, brush washer, and cabinet washer have been implemented to increase HACCP compliance. III. NEW FOOD SAFETY RULES On July 6, 1996, President Clinton announced sweeping reform of federal food safety rules for meat and poultry. The new rules modernize a 90-year-old inspection program. This was the fundamental change in meat and poultry inspection called for by the National Academy of Sciences and many other experts throughout government, industry, and the consumer community. This new HACCP-based food safety system builds on the public health principle of prevention for every meat and poultry production process [4–6]. The major points outlined are: 1. Every plant must have a written HACCP plan for each product they produce. 2. Plants will be required to do microbiological testing for generic E. coli to verify the process is in control. 3. Plants will be required to meet speciﬁc performance standards for the presence of Salmonella. 4. Plants will be required to have a written standard operating procedure for preoperational and operational sanitation, including cleaning of plant and equipment and recordkeeping. 5. The USDA will audit records and verify inspections to assure that the programs are working. 6. The USDA will conduct Salmonella tests to ensure that each plant is meeting the established performance standard. Overall, a written HACCP plan is the heart of the new inspection program. These new rules apply to over 6200 slaughtering and processing plants that operate under federal © 2003 by Marcel Dekker, Inc.

inspection. The same or equivalent requirements will apply to state-inspected meat and poultry plants and to foreign plants that export to the United States. The implementation dates for HACCP are based on plant size. The largest plants were required to have their HACCP systems in place by January 26, 1998. Smaller plants (less than 500 employees) had until January 25, 1999. Very small plants (less than 10 employees or an annual sales of less than $2.5 million) had until January 25, 2000. To be effective, HACCP-based processing control must be combined with objective means of verifying that meat and poultry plants are achieving acceptable levels of food safety performance. The Food Safety and Inspection Service (FSIS) of the USDA required all slaughtering plants to conduct microbial testing for generic E. coli on January 27, 1997. In addition, FSIS is establishing pathogen reduction performance standards for Salmonella, and the implementation dates for the standards are based on plant size and coincide with those for the HACCP plan. All plants must prepare and implement plant-speciﬁc standard operating procedures (SOPs) for sanitation. This implementation date was January 27, 1997.

IV. PREREQUISITE PROGRAMS FOR HACCP The production of safe poultry products requires that a HACCP system be built upon a solid foundation of prerequisite programs. Without adequate programs such as good manufacturing practices (GMPs), sanitation standard operating procedures (SSOPs) and operational SOPs, HACCP is like building a skyscraper in a marsh [7]. Many of the conditions and practices are speciﬁed in federal, state, and local regulations and guidelines. In addition, industry often adopts policies and procedures that are speciﬁc to its operations. This has been accomplished through the application of GMPs. According to a publication from the National Advisory Committee on Microbiological Criterial for Food, which was published in 1997 [8], common prerequisite programs may include, but are not limited to 1. Facilities. The facilities should be located, constructed, and maintained according to sanitary design principles. 2. Supplier control. Continuing supplier guarantee and supplier HACCP system veriﬁcation. 3. Speciﬁcations. Written speciﬁcations for all ingredients, products, and packaging materials. 4. Production equipment. Constructed and installed according to sanitary design principles. Preventive maintenance and calibration schedules should be established and documented. 5. Cleaning and sanitation. All procedures should be written and followed. 6. Personal hygiene. All persons enter the manufacturing plans should follow the requirements for personal hygiene. 7. Training. All employees should receive training in personal hygiene, GMPs, cleaning and sanitation procedures, personal safety, and their role in the HACCP program. 8. Chemical control. Documented procedures must be in place to assure the segregation and proper use of non-food chemicals in the plant. These chemicals include cleaning chemicals, fumigants, pesticides, and rodenticides. © 2003 by Marcel Dekker, Inc.

9. Receiving, storage, and shipping. All raw materials and products should be stored under sanitary conditions. 10. Traceability and recall. All raw materials and products should be lot-coded and a recall system in place so that rapid and complete traces and recalls can be done when necesssary. 11. Pest control. An effective pest control system should be in place. Other prerequisite programs might include quality assurance procedures; standard operating procedures for sanitation and processes; product formulations and recipes; glass control; procedures for receiving, storage, and shipping; labeling; and employee food and ingredient handling practices. Good manufacturing practices and sanitation standard operating procedures are two fundamental programs which have been developed and implemented in all USDA-inspected meat and poultry processing plants. These programs are closely interrelated and an import part of processing control. Plants that have GMPs and SSOPs will have a much easier time developing HACCP plans than companies which do not have them. The relationship among these programs can be demonstrated in the following pyramid:

V.

GOOD MANUFACTURING PRACTICES

Good manufacturing practices are the minimum sanitary and processing requirements necessary to ensure the production of wholesome food; GMPs are broad and general in nature. They can be used to explain tasks which are part of many jobs. In many cases, GMPs are often referred to as CGMPs, which means current good manufacturing practices. Good manufacturing practices are usually written for each of the following areas: 1. Personnel. Includes disease control, cleanliness, education and training, and supervision. 2. Buildings and facilities. Includes the building surrounding grounds, plant construction and design, sanitary operations, etc. 3. Equipment and utensils. All plant equipment and utensils should be so designed and of such material and workmanship to be adequately cleanable and should be properly maintained. 4. Production and process control. Includes sanitation practices for all functions; inspection, storage, and cleaning of raw materials and ingredients; and procedures for processing operations. 5. Records and reports. Record ﬁling and maintaining for supplier, processing and production and distribution. It also includes a record retention schedule. © 2003 by Marcel Dekker, Inc.

6.

7.

Defect action levels. The defect limit at which FDA will take action. The levels are set on the basis of no hazards to health and does not excuse failure to observe the sanitary requirements. Miscellaneous. Such as visitor rules.

The Food and Drug Administrations (FDA) requirements for GMPs are listed in Title 21, Code of Federal Regulations, Part 110. VI. SANITATION STANDARD OPERATING PROCEDURES The new regulations require that all meat and poultry plants develop, implement and maintain written sanitation standard operating procedures [9]. Each SSOP must itemize the daily sanitation procedures plant personnel will conduct before and during operations to prevent direct contamination or adulteration. Additionally, plans must identify the plant ofﬁcial(s) responsible for implementing and monitoring daily sanitation activities. The inspection agency has intentionally left the SSOP requirements vague to grant establishments maximal ﬂexibility. The principal evidence that a plan has been followed will be the written documentation/checklists conﬁrming that various tasks have been performed. Records relating to SSOPs, including records regarding any deviations and corrective actions, are to be held for at least 6 months and be available to inspection for veriﬁcation and monitoring. All records relevant to the SSOPs must be stored in the establishment for at least 48 hr after the day they were created. After that, the records may be stored off-site, provided they can be made available to agency ofﬁcials within 24 hr. Inspectors will not initially approve establishment SSOPs. However, the rules do specify that FSIS inspectors ‘‘verify the adequacy and effectiveness’’ of the SSOPs. A.

Developing the SSOP Blueprint

An SSOP must 1. 2. 3.

4.

B.

Describe all procedures (identifying preoperational and production procedures separately) that an establishment will conduct to maintain proper sanitation. Specify the frequency of the procedures. Identify the individual(s) responsible for implementing and monitoring the SSOP (not necessarily the employee actually performing the speciﬁc sanitation task). Be signed and dated by the indivual with on-site implementation authority (or a higher level ofﬁcial) when adopted and modiﬁed.

Two Major Parts of Poultry Processing SSOPs

1. Preoperational Sanitation All equipment should be cleaned and sanitized prior to starting production. The SOP should include procedures for cleaning and sanitizing equipment, implementing method, monitoring, recordkeeping, as well as corrective actions. The following is an example for the procedures for cleaning and sanitizing equipment: 1. 2.

The equipment is exposed for cleaning by removing covers and shields. Product debris is removed.

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3. Equipment parts are rinsed with water. 4. An approved cleaner or detergent is applied to the parts and cleaned according to manufacturer directions. 5. Equipment parts are rinsed with potable water. 6. Equipment is sanitized with an approved sanitizer or disinfecting agent and rinsed with potable water if required. Usually, the sanitizers are left on the equipment for 10 min prior to the rinsing. 7. The equipment covers and shields are replaced. 8. The equipment is resanitized with an approved sanitizer and rinsed with potable water if required. In the United States the disinfectants cleared for use in poultry processing plants are chlorinated compounds and quaternary ammonium compounds. Quaternary ammoniums must be rinsed off before production begins. Other recommended poultry processing equipment cleaning procedures are 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Lock out/disconnect electrical power and cover electrical equipment. Equipment breakdown by trained personnel. Dry pick-up/large debris removal. Prerinse (115–125°F, or 46.1–51.7°C), physical removal of material. Cleaning compound application (125–130°F, or 51.7–54.4°C). Additional cleaning/scrubbing, green padding, and agitation. Inspection and touch up. Sanitizing. Monitoring. Reassembly by trained personnel.

2. Operational Sanitation The objective of this operational sanitation is to prevent the contamination of the products during processing, cutting, and packaging. For example, the following statements should be included in the standard operation procedures for evisceration: 1. Employees will clean hands, arms, and any personal protective equipment (such as gloves, aprons, etc.) as often as necessary during the processing procedure. 2. The evisceration equipment is ﬁtted with spray nozzles to help remove buildup and to clean equipment during operation. The water used will be potable water. 3. Processing employees will maintain clean hands, arms, clothes, and personal protective equipment throughout the process. If contamination occurs, the employee is required to clean and sanitize the contaminated equipment. 4. Floors and ceilings are cleaned as needed to prevent product contamination. Again, the SOP for a speciﬁed operation should include procedures for monitoring, recordkeeping, and corrective action. In general, the plant manager is responsible for ensuring that employee hygiene practices, sanitary conditions, and cleaning procedures are maintained during the production. The quality control (QC) manager assigns staff that monitors the operational sanitation procedures twice during a production shift. © 2003 by Marcel Dekker, Inc.

Overall, in SSOP developing, the following items should be included: 1. 2.

3. 4. 5.

Established detailed procedures to prevent contamination before and during operation. Identiﬁed person(s) responsible for evaluating the cleaning process effectiveness and making corrections. Procedures for prevention of contamination should be included. Daily monitoring procedures and microbial tests. Daily record and prescribed review procedures for veriﬁcation with corrective activities. Procedures for the following areas: equipment, facilities, welfare, personnel, and environment.

The bottom line for effective sanitation is improved company proﬁts through reduced product losses, increased shelf-life, and customer satisfaction. VII. HACCP PLAN FOR POULTRY PROCESSING Keeping low production cost is an important main goal for food manufacturers and processors. More automatic and high speed processing equipment have been used to minimize processing times. New formulations have also been designed to reduce preparation time by the consumer. These changes have increased the degree of risk regarding food safety. According to most regulators and industry ofﬁcials, the most effective and economical way to combat food safety problems is through the use of a preventive HACCP system. A.

Deﬁnition

Hazard analysis is the identiﬁcation of sensitive ingredients, critical processing points, and relevant human factors as they affect product safety. Critical control points are those areas of processing where loss of control would result in an unacceptable food safety risk. B.

History

The HACCP system was formalized by the Pillsbury Company as part of the work in a program to develop foods for the space program. It was ﬁrst presented at the 1971 National Conference on Food Protection. The HACCP system began to gain considerable interest when it was ﬁrst applied to low-acid and acidiﬁed foods. In addition, the FDA started using the HACCP approach in its investigation activities. In 1980, the FDA, National Marine Fisheries Service (NMFS), USDA, and the US Army Natick R&D Center asked NAS/NRC to convince a subcommittee to formulate general principles for the application of microbiological criteria to food. In its report (NAS/NRC, 1985), the subcommittee recommended the use of HACCP in food protection programs and that food industry and regulatory personnel be trained in the elements of HACCP. To be effective, the HACCP program should deal only with issues related to food safety and should not be incorporated into the company’s normal quality control system. The same preventive approach can be used for quality and other nonsafety issues, but these programs should not be called HACCP. Do things right the ﬁrst time is the essence of total quality control and preventing problems before they occur are the essence of the HACCP system. They are very closely related. For HACCP to be effective, it must be © 2003 by Marcel Dekker, Inc.

applied in all segments of the industry, from production to consumption, including growing, harvesting, ingredient production, processing, distribution, retailing, food service, and the home. C. Three Types of Hazards 1. Biological Hazards Biological hazards are living organisms, including microorganisms, that can put human health at risk. Biological hazards include bacteria, parasites, protozoa, viruses, etc. The primary biological hazards of concern in meat and poultry processing are Salmonella, Staphylococcus aureus, Campylobacter jejuni, Clostridium perfringens, Clostridium botulinum, Listeria monocytogenes, and Escherichia coli O157:H7. 2. Chemical Hazards There are two categories of chemical hazards: 1. Naturally occurring toxins, chemicals, or deleterious substances that are natural constituents of foods and are not the result of environmental, agricultural, industrial, or other contamination. Examples of these hazards include aﬂatoxins, mycotoxins, and shellﬁsh toxins. 2. Added chemicals or deleterious substances that are intentionally or unintentionally added to foods at some point in growing, harvesting, storage, processing, packaging, or distribution. This group of hazards includes pesticides, fungicides, insecticides, fertilizers, drug residues, antibiotics, certain food additives, lubricants, cleaners, paints, coatings, etc. 3. Physical Hazards A physical hazard is any material not normally found in a food which causes illness or injury to the consumer. Physical hazards include a variety of foreign objects such as glass, metal, and plastic. Foreign objects which cannot cause illness or injury are not hazards. D. General Steps for the Development of a HACCP Plan The following steps may be taken to develop a HACCP plan [10,11]: 1. Assemble a HACCP team. This is a team of individuals representing certain disciplines (e.g., engineering, quality assurance, production, microbiology, sanitation). The team should include local personnel from the processing operation because they will be the most knowledgeable of the actual conditions which occur during processing, including the variability and limitation of the operation. 2. Describe the food and its distribution. This includes the characteristics of the food ingredients, the ingredients’ intended shelf-life, processing methods, type of packaging used, storage, and distribution system. 3. Identify intended use and consumers of the food, including the preparation and cooking procedures, and the consumers. 4. Develop and verify ﬂow diagram. The diagram should indicate where ingredients enter the ﬂow, the various manufacturing and fabrication steps, packaging, storage, © 2003 by Marcel Dekker, Inc.

distribution, point-of-sale, and consumer handling. A block type ﬂow diagram and CCP of a poultry processing plant is presented in Fig. 1. 5. Conduct analysis of hazards. Based on information developed in the previous steps, a risk analysis should be conducted for microbial, chemical, and physical hazards associated with the speciﬁc food on the processing line. 6. Identify critical control points. A critical control point is deﬁned as a point, step, or procedure in a processing at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level. Critical control points can be identiﬁed from the manufacturing and distribution ﬂow diagrams. 7. Establish critical limits. These are the pass/fail components of a HACCP system: the maximum or minimum value to which a physical, biological or chemical hazard must be controlled to prevent, eliminate, or reduce to an acceptable level the occurrence of the identiﬁed food safety hazard. 8. Establish an effective monitoring system. Each critical control point should have its own sampling plan, test methods, and decision criteria. Monitoring should be continuous or should be done as frequently as necessary to give a reliable indication of hazard control. For time concerns, the monitoring procedure must be a rapid method that can be applied on the processing line. 9. Determine appropriate corrective actions. Corrective action plans must identify what steps will be taken and who is responsible for taking action. 10. Verify that the system works. Periodic review should be conducted to ensure that the HACCP program is working correctly. The ﬁrst veriﬁcation process is the initial validation of the HACCP plan, which requires plant management to demonstrate the adequacies of the CCPs, the critical limits, the monitoring and recordkeeping procedures, and the corrective action plans. In addition, validation must include review of records as they are generated. Ongoing veriﬁcation activities are the cornerstones of the second validation process. These activities ensure the systems are being implemented as designed and include calibration of process-monitoring equipment, direct observation of monitoring activities, corrective actions, and a review of the records. The third veriﬁcation process is the documented reassessment of the HACCP plan. This step mandates that a HACCP-trained individual review the HACCP plan to determine its continued adequacy whenever there is any relevant change such as a new product or process. In addition to the three veriﬁcation activities plant ofﬁcials must manage, FSIS personnel will conduct their own veriﬁcation activities. These include reviewing the HACCP plan, CCP records, and critical limits; determining the adequacy of corrective actions taken; making direct observations or measurements at a CCP; and taking samples. The frequency of these activities will depend on a plant’s prior history and the risk posed by the operation. 11. Maintain accurate records. Effective recordkeeping is necessary to ensure a HACCP program is completely documented. Slaughter records and processing records for refrigerated products must be held for 1 year. Processing records for frozen, preserved, or shelf-stable products must be held for 2 years. E.

Some Basic Components of a HACCP System 1.

A hazard analysis is performed and potential hazards are identiﬁed and prioritized according to severity and risk.

© 2003 by Marcel Dekker, Inc.

Figure 1 Flow diagram and CCPs of a poultry processing plant. © 2003 by Marcel Dekker, Inc.

2. 3. 4. 5. 6. 7.

F.

Critical points in the operation which permit control of the hazards are identiﬁed. Criteria (e.g., time, temperature, pH) are speciﬁed that indicate whether an operation is under control at a particular CCP. Rapid tests are used to monitor whether the CCPs are under control. The sampling frequency is determined by the severity and risk of the hazard. Corrective action is taken when monitoring results indicate that the operation is not under control. Veriﬁcation tests are used to check that the overall HACCP system is working and that all hazards have been identiﬁed. Records are maintained and reviewed. Records include action taken when criteria have not been met.

Eight Control Points Identiﬁed for Poultry Processing

A HACCP team from poultry operation would conduct a hazard analysis for the production of ready-to-cook chickens, which includes: (1) scalding, (2) venting, opening, and eviscerating, (3) off-line reconditioning, (4) ﬁnal washing, (5) carcass chilling, (6) product packaging, (7) product chilling, and (8) storage and shipping (Fig. 1). A CCP1 will assure the hazard control, while a CCP2 will minimize but cannot assure the control of a hazard. Both types of CCPs are important and both must be controlled. The chilling operation belongs to CCP1; scalding, washing, eviscerating, and ﬁnal washing belong to CCP2. Overall, the following recommendations are made to reduce the safety risk in poultry operations: 1. 2. 3. 4. 5.

Use chlorine in chiller. Separate raw and cooked products. For fresh product, keep processing area 50°F (10°C) or lower. Improve fresh meat handling practices. Commit to quality at the management level.

A HACCP master sheet of a poultry processing operation is given to further demonstrate the stages of HACCP development in Table 2. The slaughter records and processing records for refrigerated products must be held for 1 year. Processing records for frozen, preserved, or shelf-stable products must be held for 2 years. To facilitate the preparation of mandated HACCP plans, the FSIS of the USDA has published many generic HACCP models. Much of the information can be found on the internet at the following address: http://www.usda.gov/agency/fsis. Samples of various poultry processing HACCP worksheets are given in Figs. 2–9. G.

Pathogen Reduction and Microbial Testing

The new HACCP rule mandates two microbial tests: company tests for generic E. coli and FSIS testing for Salmonella. A wide range of pathogen-reduction technologies are available for company ofﬁcials to evaluate. The FSIS urges companies to consider implementing the approved technologies. Antimicrobial treatments include washers or sprayers that use either hot water or a solution of water and a substance approved by FSIS for the use. Substances such as lactic, acetic, and citric acids; trisodium phosphate; and chlorine are approved. In addition, the agency has approved spray-vacuum devices that use pressurized steam or hot water. © 2003 by Marcel Dekker, Inc.

Table 2

HACCP Master Sheet of Poultry Processing Plant Critical limits

Monitoring procedures

Critical Control Point

Hazard

Scalding CCP-1 Bio

Biological

Continuous overﬂow

Fresh water input

Vent opening/ eviscerating CCP-2 Bio

Biological

Zero tolerance of malfunctioning

Salvage/ reprocessing CCP-3 Bio

Biological

CCP-3 Chem

CCP-3 Phys

How

Corrective actions

Frequency

Who

At start-up and after each break

Picking room personnel

Immediate adjustments

HACCP form: Fresh water Added to Scalder

Veriﬁed daily by HACCP coordinator

Broken or miss- Visual ining organs spection

Every hour

Eviscerating line personnel or designee

Inform supervisor and retest every 15 min

HACCP form: Vent Opening/ Eviscerating HACCP form

Veriﬁed daily by HACCP coordinator

ⱕ40°F in less than 2 hr

Internal temperature

Calibrated probe thermometer

Every 2 hr

QC technician

Re-ice and retest every 30 min

Veriﬁed daily by HACCP coordinator

Chemical

ⱖ 20 ppm of chlorine in rinse water

Effective chlorination

HACH chlorine test kits

Every hour

QC technician

Physical

Approved limits for offline reprocessing procedures for extraneous material

Foreign material

Visual inspection

Every hour

QC technician

Inform supervisor and retest in 15 min Rework lot

HACCP form: Salvage/Reprocessing Area form HACCP form: Salvage/Reprocessing Area form HACCP form: Salvage/Reprocessing Area form

© 2003 by Marcel Dekker, Inc.

What

Water ﬂow gauge on pipe

Record

Veriﬁcation

Veriﬁed daily by HACCP coordinator Veriﬁed daily by HACCP coordinator

Table 2

Continued

Critical Control Point Final wash station CCP-4 Phys

CCP-4 Chem

Hazard Physical

Chemical

Critical limits

Monitoring procedures What

How

Frequency

Who

Corrective actions

Record

Veriﬁcation

Approved limits for online processing procedures for extraneous material ⱖ 20 ppm of chlorine in rinse water

Foreign material

Visual inspection

Every hour

QC technician

Inform supervisor and retest in 15 min

HACCP form: Final Wash HACCP form

Veriﬁed daily by HACCP coordinator

Effective chlorination

HACH chlorine test kits

Every hour

QC technician

Inform supervisor and retest in 15 min

HACCP form: Final Wash HACCP form

Veriﬁed daily by HACCP coordinator

Shut down chiller or retain lot and re-ice and retest continuously Immediate adjustments

HACCP form: Carcass Chill Inspection HACCP form

Veriﬁed daily by HACCP coordinator

HACCP form: Carcass Chill Inspection HACCP form HACCP form: Carcass Chill Inspection HACCP form

Veriﬁed daily by HACCP coordinator

Carcass chilling CCP-5 Bio

Biological

ⱕ40°F at chiller exit

Internal temperature

Calibrated probe thermometer

Every hour

QC technician

CCP-5 Bio

Biological

ⱖ0.5 gallon of fresh water added per bird

Fresh water input

Water ﬂow gauge on pipe

At start-up and after each break

Chiller supervisor or designee

CCP-5 Chem

Chemical

ⱖ 20 ppm of chlorine in chiller water

Effective chlorination

HACH chlorine test kits

Every hour

QC technician

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Inform supervisor and retest in 15 min

Veriﬁed daily by HACCP coordinator

CCP-5 Phys

Physical

Approved limits for postchill processing procedures for extraneous material

Foreign material

Visual inspection

Every hour

QC technician

Retain lot and retest when product is ready

HACCP form: Veriﬁed daily Carcass Chill by HACCP Inspection coordinator HACCP form

Biological

ⱕ40°F at chiller exit

Internal temperature

Every hour

QC technician

CCP-6 Chem

Chemical

Effective chlorination

Every hour

QC technician

CCP-6 Phys

Physical

ⱖ 20 ppm of chlorine in chiller water Approved limits for giblet processing procedures for extraneous material

Calibrated probe thermometer HACH chlorine test kits

Foreign material

Visual inspection

Every hour

QC technician

Re-ice and retest every 30 min Inform supervisor and retest in 15 min Retain lot and retest when product is reworked

HACCP form: Veriﬁed daily Giblet Chill by HACCP HACCP form coordinator HACCP form: Veriﬁed daily Giblet Chill by HACCP HACCP form coordinator HACCP form: Veriﬁed daily Giblet Chill by HACCP HACCP form coordinator

Biological

ⱕ55°F in packed product

Internal temperature

Calibrated probe thermometer

At start-up and after each break

QC technician

HACCP form: Veriﬁed daily Product Hanby HACCP dling coordinator HACCP form

Physical

Visually intact

Labeling material integrity

Visual inspection

At start-up and after each break

Production supervisor or designee

Retail lot and retest when product is hold in the cooler Control product for corrective action. Immediate adjustment to procedures

Biological

USDA regulations for product storage

Product temperature

Calibrated probe thermometer

At start-up and after each break

Cooler supervisor or designee

Control product for corrective action. Immediate adjustment to procedures

HACCP form: Veriﬁed daily Storage Area by HACCP HACCP form coordinator

Giblet chilling CCP-6 Bio

Packing/Labeling CCP-7 Bio

CCP-7 Phys

Storage CCP-8 Bio

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HACCP form: Veriﬁed daily Product Hanby HACCP dling coordinator HACCP form

HACCP RECORD Processing Plant CCP—Picking Room Fresh Water Added to Scalder Critical Limits Fresh Water Input, ⬎ or ⫽ 1/2 Gallon per Bird (2 Checks Every Break Time) Records Veriﬁed within 30 Minutes of Monitoring

Shift:

Date:

Corrective Actions 1. 2.

Inform Picking Room supervision to determine cause, to effect immediate adjustment or apply other measure to prevent occurrence. Effect appropriate scalder adjustment.

Figure 2

Sample picking room CCP form.

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HACCP RECORD Processing Plant CCP—Vent Opening/Eviscerating HACCP Form Critical Limits 0 Missing of Intestinal Organs (10 Birds Checked per 1 Hour of Production) 0 Extraneous Material i.e. Fecal Contamination (10 Birds Checked per 1 Hour of Production) Records Veriﬁed within 15 Minutes of Monitoring

Shift:

Date:

Corrective Actions 1. 2.

Inform Eviscerating Room Supervision to determine cause, to effect immediate adjustment or apply other measure to prevent occurrence. Effect appropriate eviscerating adjustment.

Figure 3

Sample vent/opening/eviscerating CCP form.

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HACCP RECORD Processing Plant CCP—Salvage/Reprocessing Area Form Critical Limits Temperature, ⬍ or ⫽ 40°F (3 Pieces of Parts Checked per 2 House of Production) Chlorine, ⬎ or ⫽ 30 PPM of Chlorine (Every 1 Hour) 0 Extraneous Material i.e. Fecal Contamination (10 Birds Checked per Hour of Production) Records Veriﬁed within 30 Minutes of Monitoring

Shift:

Date:

Corrective Actions Rework or recondition Product to remove contamination Figure 4

Sample salvage/reprocessing area CCP form.

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HACCP RECORD Processing Plant CCP—Final Wash HACCP Form Critical Limits Chlorine, ⬎ or ⫽ 20 PPM of Chlorine (Every 1 Hour) 0 Extraneous Material i.e. Fecal Contamination (10 Birds Checked per 1 Hour of Production) Records Veriﬁed within 30 Minutes of Monitoring

Shift:

Date:

Corrective Actions 1. 2.

Inform Maintenance and Supervision for immediate Correction or adjustment. Retest after adjustment is effected.

Figure 5

Sample ﬁnal wash CCP form.

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HACCP RECORD Processing Plant CCP—Carcass Chill Inspection HACCP Form Critical Limits Temperature, ⬍ or ⫽ 40°F (3 Birds per 1 Hour of Production) Fresh Water Input, ⬎ or ⫽ 1/2 gal. per Bird (Start-up and Each Break Time) Chlorine, ⬎ or ⫽ 30 PPM of Chlorine (Every 1 Hour) 0 Extraneous Material i.e. Fecal Contamination (10 Birds Checked per 1 Hour of Production) Records Veriﬁed within 30 Minutes of Monitoring

Shift:

Date:

Thermometer Calibration

Date:

QC Tech. Signature: Corrective Actions

1. 2.

QC/Chiller Supervisor to determine cause, to effect immediate adjustment or apply other measure to prevent occurrence. All birds exiting the chiller until ⬍ 40°F is achieved.

Figure 6

Sample carcass chill CCP form.

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HACCP RECORD Processing Plant CCP—Giblet Chill HACCP Form Critical Limits Temperature, ⬍ or ⫽ 40°F (3 Pieces Checked per 1 Hour of Production) Chlorine, ⬎ or ⫽ 30 PPM of Chlorine (Every 1 Hour) 0 Extraneous Material i.e. Fecal Contamination (10 Birds Checked per 1 Hour of Production) Records Veriﬁed within 30 Minutes of Monitoring

Shift:

Date:

Thermometer Calibration

Date:

QC Tech. Signature: Corrective Actions

1. 2.

Hold all out of speciﬁc products in holding cooler until ⬍ or ⫽ 40°F is achieved (Condemn if ⬎ 40°F in 2 hours) Retest continuously until temperature is ⬍ or ⫽ 40°F.

Figure 7

Sample giblet chill CCP form.

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HACCP RECORD Processing Plant CCP—Product Handling HACCP Form Critical Limits Temperature, ⬍ or ⫽ 55°F (2 Parts Checked Every Break Time) Visually Intact of Packing Material Integrity on Product (2 Packs Checked Every Break Time) Records Veriﬁed within 30 Minutes of Monitoring

Shift:

Date:

Thermometer Calibration

Date:

Time:

QC Technicians: Corrective Actions

1. 2.

Inform Refrigeration and Supervision for immediate correction or adjustment. Condemn all affected products (Temperature ⬎ 55°F).

Figure 8

Sample product handling CCP form.

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HACCP RECORD Processing Plant CCP—Storage Area HACCP Form Critical Limits Temperature, ⬍ or ⫽ 28°F (2 Checks Every Break Time) Records Veriﬁed within 30 Minutes of Monitoring

Shift:

Date:

Thermometer Calibration

Date:

Corrective Actions 1. 2.

Inform Refrigeration and Supervision for immediate correction or adjustment. Condemn all affected products (Temperature ⬎ 55°F).

Figure 9

Sample storage area CCP form.

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Time:

All poultry slaughter plants test carcasses for E. coli. The testing frequency is based upon the production volume; for chickens, 1 sample per 22,000 carcasses; for turkeys, 1 sample per 3000 carcasses. For a very low volume establishment (less than 440,000 chickens per year, or not more than 60,000 turkeys per year), alternative testing is required. Before sampling starts, a company must prepare written procedures specifying when samples will be taken, who is responsible for sampling, how samples will be handled, and what test methods will be used. Poultry samples are to be collected after the drip line and before packaging or cut-up, using a whole-bird rinse. The performance criteria vary by species and are based upon FSIS baseline surveys. An establishment will be deemed out of compliance if the level of E. coli found on the most recent sample is above the upper permitted level or three samples are above the lower permitted level. For broilers, the product is unacceptable if the level of E. coli on any sample is above the upper permitted level of 1000 cfu/mL or three samples test positive above the lower permitted level of 100 cfu/mL. Once a plant is subjected to mandatory HACCP requirements, FSIS will sample carcasses and raw ground products for Salmonella. The standards for poultry products, derived from FSIS national baseline surveys, are as follows:

Class of product

Performance standard (% positive)

Number of sample tested

Maximum number positive

Broiler Ground chicken Ground turkey

20.0 44.6 49.9

51 53 53

12 26 29

Failure to comply with a performance standard will be met with a measured response, including possible suspension of inspection. H.

Beneﬁts of HACCP Plan

The HACCP-based inspection program is better than the traditional inspection. The inspector is not conﬁned to one location on a line. It allows the inspector to move up and down the line to look for problem areas and to take action on those carcasses, if necessary. Data published by the USDA’s FSIS indicated that 20% of broiler carcasses inspected in 1997 were contaminated with salmonella. Since the implementation of HACCPbased inspection, this number was reduced to 10.3% for broiler carcasses inspected in January 2000. In addition, on those 10.3% birds that tested positive for salmonella, the actual numbers of organisms recovered were very, very low. In most cases, ﬁr or six cells were recovered from these birds [12]. It is a common understanding that 5 years ago this salmonella on carcasses was 50% and was much more than that if we go back a few more years. This reduction in the incidence of salmonella on broiler carcasses has demonstrated the success of the HACCP-based inspection program in poultry food safety improvement. REFERENCES 1. AW Brant, JW Goble, JA Hamann, CJ Wabeck, RE Walter. Guidelines for establishing and operating broiler processing plants. Washington, DC: U.S. Department of Agriculture, 1982.

© 2003 by Marcel Dekker, Inc.

2. GJ Mountney, CR Parkhurst. Poultry Product Technology. New York: Haworth Press, 1995. 3. WJ Stadelman, VM Olson, GA Shemwell, S Pasch. Egg and Poultry-Meat Processing. Chichester, England: Ellis Horwood, 1988. 4. K Nunes. The Mega-Reg, FSIS mandates HACCP, pathogen testing and SOPs and prepares for the future. Meat & Poultry September:15–34, 1996. 5. USDA. The ﬁnal rule on pathogen reduction and hazard analysis and critical control point (HACCP) systems. Washington, DC: U.S. Department of Agriculture, 1996. 6. USDA. Sanitation standard operating procedures (SSOP) reference guide. Washington, DC: U.S. Department of Agriculture, 1996. 7. D Buege, S Ingham. Cleaning and sanitizing, the cornerstone of quality. Meat & Poultry May: 25–39, 1996. 8. USDA. Hazard analysis and critical control point, principles and application guidelines. Washington, DC: U.S. Department of Agriculture, 1997. 9. R Savage. The sanitation S.O.P. deadline is ﬁnally here. Meat & Poultry January:59, 1997. 10. USDA. Generic HACCP model for poultry slaughter. Washington, DC: U.S. Department of Agriculture, 1994. 11. U.S. Poultry & Egg Association. Introduction to HACCP, a pre-HACCP training guide. Atlanta, GA: U.S. Poultry & Egg Association, 1997. 12. C Cannon. Where have all the pathogens gone? Poultry 8(5):14–17, 2000.

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32 Seafood Processing: Basic Sanitation Practices PEGGY STANFIELD Dietetic Resources, Twin Falls, Idaho, U.S.A.

I.

BACKGROUND INFORMATION

The U.S. national regulatory authority for public protection and seafood regulation is vested in the Food and Drug Administration (FDA). The FDA operates an oversight compliance program for ﬁshery products, which sets responsibility for product safety, wholesomeness, identity, and economic integrity with the processor or importer, who must comply with regulations promulgated by the FDA. In addition, FDA operates the low-acid canned food (LACF) program which is based on the hazard analysis and critical control point (HACCP) concept and is focused on thermally processed, commercially sterile foods, including seafood such as canned tuna and salmon. The seafood processing regulations, which became effective on December 18, 1997, require that a seafood processing plant (domestic and exporting foreign countries) implement a preventive system of food safety controls known as a hazard analysis and critical control point plan. The plan essentially involves (1) identifying food safety hazards that, in the absence of controls, are reasonably likely to occur in the products and (2) having controls at ‘‘critical control points’’ in the processing operations to eliminate or minimize the likelihood that the identiﬁed hazard will occur. These are the kinds of measures that prudent processors already take. The HACCP plan provides a systematic way of taking those measures that demonstrates to the FDA, customers, and consumers that the ﬁrm is routinely practicing food safety by design. Seafood processors that have fully operating HACCP systems advise us that they beneﬁt in several ways, including having a more safety-oriented workforce, less product waste, and generally fewer problems. Most FCA in-plant inspections consider product safety, plant/food hygiene, and economic fraud issues, while other inspections address subsets of these compliance con© 2003 by Marcel Dekker, Inc.

cerns. Samples may be taken during FDA inspections in accordance with the agency’s compliance programs and operational plans or because of concerns raised during individual inspections. The FDA has laboratories around the country to analyze samples taken by its investigators. These analyses are for a vast array of defects including chemical contaminants, decomposition, net weight, radionuclides, various microbial pathogens, food and color additives, drugs, pesticides, ﬁlth, and marine toxins such as paralytic shellﬁsh poison (PSP) and domoic acid. In addition, FDA has the authority to detain or temporarily hold food being imported into the United States while it determines if the product is misbranded or adulterated. The FDA receives notice of every seafood entry and, at its option, conducts wharf examinations, collects and analyzes samples, and, where appropriate, detains individual shipments or invokes ‘‘automatic detention,’’ requiring private or source country analysis of every shipment of product when recurring problems are found before the product is allowed entry. Further, FDA has the authority to set tolerances in food for natural and manmade contaminants, except for pesticides, which are set by EPA. The FDA regulates the use of food and color additives in seafood and feed additives and drugs in aquaculture. The FDA also has the authority to promulgate regulations for food plant sanitation [i.e., good manufacturing practices (GMP) regulations], standards of identity, and common or usual names for food products. The FDA has the authority to take legal action against adulterated and misbranded seafood and to recommend criminal prosecution or injunction of responsible ﬁrms and individuals. The FDA conducts both mandatory surveillance and enforcement inspections of domestic seafood harvesters, growers, wholesalers, warehouses, carriers, and processors. The frequency of inspection is at the agency’s discretion, and ﬁrms are required to submit to these inspections, which are backed by federal statutes containing both criminal and civil penalties. The FDA provides ﬁnancial support by contract to state regulatory agencies for the inspection of food plants, including seafood. The FDA also operates two other speciﬁc regulatory programs directed at seafood— the Salmon Control Plan and the National Shellﬁsh Sanitation Program (NSSP), recently augmented by the Interstate Shellﬁsh Sanitation Conference (ISSC). These are voluntary programs involving individual states and the industry. The Salmon Control Plan is a voluntary, cooperative program among the industry, FDA, and the National Food Processors Association (NFPA). The plan is designed to provide control over processing and plant sanitation and to address concerns about decomposition in the salmon canning industry. Consumer concerns about molluscan shellﬁsh are addressed through the National Shellﬁsh Sanitation Program. It is administered by FDA and provides for the sanitary harvest and production of fresh and frozen molluscan shellﬁsh (oysters, clams, and mussels). Participants include the 23 coastal shellﬁsh-producing states and nine foreign countries. The NSSP was created upon public health principles and controls formulated at the original conference on shellﬁsh sanitation called by the Surgeon General of the U.S. Public Health Service in 1925. These fundamental components have evolved into the National Shellﬁsh Sanitation Program Manual of Operations. A prime control is proper evaluation and control of harvest waters and a system of product identiﬁcation which enables trace back to harvest waters.

© 2003 by Marcel Dekker, Inc.

The FDA conducts reviews of foreign and domestic molluscan shellﬁsh safety programs. Foreign reviews are conducted under a memorandum of understanding (MOU) which FDA negotiates with each foreign government to assure that molluscan shellﬁsh products exported to the United States are acceptable. The FDA’s regulation on HACCP for seafood processing have been in full force since 1997. The HACCP system, in addition to other scientiﬁc and technical considerations, is an extension of the basics of food processing sanitation, which uses FDA’s current good manufacturing practice regulations (CGMPR) and the Food Code as frames of reference. The FDA considers such sanitation compliance a prerequisite to HACCP planning and implementation. This chapter discusses those prerequisites of basic sanitation for seafood processing. If you are a seafood processor and you are planning to start the HACCP program, you must ﬁrst examine the current practices of your operation to ascertain that it complies with such prerequisites. The information presented in this chapter has been modiﬁed from the CGMPR of the FDA and the U.S. Department of Agriculture (USDA), the Food Code, and other documents issued by the FDA on inspection of seafood processing plants. The format and style used in this chapter reﬂects the instructional process between a teacher (e.g., a training supervisor) and student (e.g., company personnel). II. FRESH AND FROZEN FISH A. Sanitation Critical Factors The critical factors to remember when a company ofﬁcer performs a sanitation inspection of a processing plant for fresh and frozen ﬁsh are as follows: 1. Look for evidence of rodents, insects, birds, or pets within the plant. 2. Observe employee practices including hygenic practices, cleanliness of clothing, and the use of proper strength hand-dip solutions. 3. Check to see if ﬁsh are inspected upon receipt and during processing for decomposition, off-odors, parasites, etc. Check for decomposition and parasites during establishment inspection. 4. Ascertain if equipment is washed and sanitized during the day and at the beginning and end of the daily production cycle. 5. Check if the ﬁsh are washed with a vigorous spray after eviseration and periodically throughout the process prior to packaging. 6. Determine the method and speed of freezing for frozen ﬁsh and ﬁsh products. 7. Check use of rodenticides and insecticides to assure that no contamination occurs. 8. Observe handling from boats to ﬁnished package and observe any signiﬁcant objectionable conditions. Speciﬁc details on the sanitation are as follows. B. Raw Materials 1. Determine what tests are conducted on incoming ﬁsh for decomposition, parasites, chemical contamination, etc. 2. Determine disposition of incoming ﬁsh which have been found to be decom-

© 2003 by Marcel Dekker, Inc.

3.

4. 5. 6.

7. 8.

C.

posed, contain excessive parasites, or contaminated with mercury, pesticides, etc. Conduct organoleptic examination of incoming ﬁsh products, especially those which have thawed for processing or held for prolonged periods of time at room temperature during processing. Give attention to ﬁsh arriving at the plant as to effectiveness of elimination of decomposed ﬁsh, and check ﬁsh actually being packed. Determine percentage of decomposed units encountered, classifying each as passable (class 1), decomposed (class 2), or advanced decomposed (class 3). Examine susceptible ﬁsh for parasitic infestations (e.g., white ﬁsh, rose ﬁsh, tullibees, ciscos, inconnus, blueﬁsh, herring, etc.). Check other raw materials and storage areas for rodents, insects, ﬁlth, or other contaminating factors. See required speciﬁcation on other raw materials for bacterial load, etc. (e.g., received under a Salmonella-free certiﬁcate issued by a recognized government or private agency). Check for misuse of dangerous chemicals including insecticides and rodenticides. If ﬁsh are received directly from boats, see if hook is used for loading and unloading or, for that matter, if a hook is used for any handling of the ﬁsh.

Manufacturing 1. Study manufacturing procedure. Include ﬂow plan. 2. Study type of equipment used as to construction, materials, ease of cleaning, etc. 3. Observe equipment cleaning and sanitizing procedures, and evaluate their adequacy. 4. Observe evisceration procedure, ﬁlleting procedure, or other butchering procedures used. 5. Determine source of water used in operation. Check that only potable water from an approved source is used. 6. If, during processing of ﬁsh, there are long delays at room temperature, check for decomposition. 7. Examine all handling steps and intermediate steps in processing that could lead to the contamination of the ﬁsh with ﬁlth and/or bacteria. 8. Study holding times and temperatures during the processing operation. 9. If battering and/or breading ﬁsh is involved, check process carefully. In addition, check times and temperature and for other possible routes of ﬁlth and/ or microbial contamination. 10. Evaluate compliance with good manufacturing practices.

D.

Controls 1. 2.

Check coding system. If no code marks are used, mark suspect lot packages with ﬂuorescent crayon for later sampling. Review records regarding ﬁnished product assay for decomposition, parasites, microbial load, pesticides, mercury, and for other quality factors.

© 2003 by Marcel Dekker, Inc.

3. Study labeling used on products. 4. Check use of preservatives on ﬁsh or ice. E.

Summary and Checklist

Check the following: 1. 2. 3. 4.

Compliance with CGMP. Use of adequate and proper strength hand and equipment sanitizing solutions. Proper cleanup. Evidence of rodents, insects, birds, domestic animals, or any other source of contamination.

Use the following list of indicators of sanitation to make a valid assessment of the operations at different stages of the process ﬂow.

Stage

Assessment

Receive (unload ﬁsh)

Store

Wash Fillet

Skin (either hand or machine) Rinse

Pack (either retail or block)

Freeze

1. Determination of condition of ﬁsh (acceptable or decomposed) 2. Separate work area 1. Suitable storage area (sanitation) 2. Time/temperature (icing, quality) 3. Separate work area 1. Removal of surface slime and dirt (sanitation) 2. Use of potable water 1. Personnel sanitation 2. Equipment sanitation 3. Separate work area 1. Personnel sanitation 2. Equipment sanitation 3. Separate work area, same area as ﬁllet operation 1. Potable water 2. Equipment sanitation 3. Time/temperature (quality) Equipment sanitation Personnel sanitation Suitable packaging materials Time/temperature (quality) Separate work area Time/temperature (quality)

III. CANNED TUNA A. Sanitation Critical Factors During a sanitation inspection, use the following critical factors: 1. Check adequacy of ﬁrm’s controls and review records covering the receipt of tuna ﬁsh. Ascertain if only tuna below the mercury guidelines and not decom© 2003 by Marcel Dekker, Inc.

2. 3. 4. 5.

B.

Raw Materials 1. 2. 3. 4. 5.

6. 7. 8. 9.

C.

posed is processed. Determine disposition of decomposed or over-tolerance tuna. Conduct organoleptic analysis of incoming tuna and of tuna being processed. Check food additives to determine that only those permitted by the standards are used. Check usage of insecticides and rodenticides to determine that they are used properly and do not become incidental food additives. Study controls over the canning operation to assure that only good quality tuna is canned and that it is canned in accordance with FDA requirements.

Determination adequacy of ﬁrm’s controls for assuring that they are not canning decomposed tuna or tuna with excessive mercury. Determine disposition of lots of tuna which are rejected because of excessive mercury. Review ﬁrm’s assay records and controls regarding mercury analysis of raw, in-process, and ﬁnished canned tuna. Ascertain adequacy of controls ﬁrm utilizes to assure that the species of tuna canned are those allowed by standards. Conduct organoleptic analysis of incoming raw tuna, frozen tuna which has been thawed for canning, and any tuna being held for excessively long periods at room temperature. Determine disposition of any tuna which is found to be decomposed (destruction, diversion, etc.). Check raw material storage area for presence of insects, rodents, or other possible contaminants. Check food additives in storage to ascertain if they are allowed in canned tuna as per 21 CFR 161.190(a) (Canned Tuna Standards). Check ﬁrm’s storage of rodenticides and insecticides to determine that they are used in accordance with instructions and are not becoming secondary food additives.

Processing 1. 2. 3. 4. 5. 6.

7.

Check ﬁrm’s can seamers to determine if they are functioning properly. Determine adequacy of ﬁrm’s check on can seaming. Determine if ﬁrm’s retorts or continuous cookers are functioning properly. Review recording charts from retorts and continuous cookers to ascertain if tuna was processed at proper time/temperature relationship. Determine ﬁrm’s postprocessing can handling, how cans are cooled and whether water is clean and chlorinated. Examine ﬁsh at critical points in the processing procedure for organoleptic quality such as a. In butchering state, prior to precook b. After precook before being canned (no long holding time after precook) c. After any period the tuna has been held excessively long at room temperature Evaluate ﬁrm’s canning operation for compliance with the GMPRs for low-acid foods (21 CFR 113).

© 2003 by Marcel Dekker, Inc.

8. Check plant for proper screening and rodent prooﬁng to eliminate insects and/ or rodents. D. Sanitation Check the following: 1. Firm’s operation for compliance with GMPRs for human foods. (21 CFR 110— Sanitation). 2. Firm’s equipment cleaning and sanitizing operation and its effectiveness. 3. Adequate hand washing and sanitizing facilities have been provided and signs are posted directing employees to use them. 4. Employees use of hand sanitizing solutions and whether solutions are maintained at proper strength. 5. Firm’s usage of insecticides and rodenticides so they do not become incidental food additives. 6. Freezers for proper storage temperatures and for sanitary storage. 7. Firm’s records regarding assay of ﬁnished product for mercury, decomposition, and other quality factors. 8. Firm’s assay records to determine if the canned tuna complies with the standard (21 CFR 161.190). 9. Food additives used are permitted by the standards and other legal requirements. IV. OYSTERS Most oyster shucking operations are handled by state inspection agencies. For procedures see FDA standard guidelines on interstate shellﬁsh sanitation. Microbiological considerations are of prime importance in any shellﬁsh gathering and processing plant. Time/ temperature abuses enter into most problems with the products. However, the high value of these products has made economic violations even more proﬁtable to the unethical operator. During an evaluation of sanitation, use the critical factors as follows: 1. Check for evidence of contamination from the presence of cats, dogs, birds, or vermin in the plant. 2. Check results of any testing conducted on incoming oysters including ﬁlth, decomposition, pesticides, and bacteria. 3. Check for possible incorporation of excessive fresh water through (1) prolonged contact with water or (2) insufﬁcient drainage. 4. Determine if employee sanitation practices preclude adding contamination (clean dress and proper use of 100 ppm chlorine equivalent hand sanitizers). 5. Determine if equipment is washed and sanitized about every 2 hr. 6. Check for time/temperature abuses that may cause rapid bacterial growth. V.

BLUE CRAB (FRESH AND PASTEURIZED)

A. Sanitation Critical Factors During a sanitation evaluation, use critical factors as follows: 1. Check for evidence of contamination from rodents, insects, ﬂies, birds, and domestic pets.

© 2003 by Marcel Dekker, Inc.

2.

3. 4. 5. 6.

Determine if employee sanitation practices preclude adding contamination (clean dress and proper use of 100 ppm chlorine equivalent hand sanitizers), particularly during pick-out of shells from crabmeat. Determine if equipment is washed and sanitized about every 2 hr. Check for time/temperature abuses which may cause rapid bacterial growth. Check testing of incoming crabs for decomposition, bacterial load, pesticides, and dead crab removal prior to processing. Check ﬁrm’s usage of rodenticides and insecticides to determine that they do not contaminate the in-process crabs.

Let us look at the sanitation aspects of the different stages of operation. B.

Raw Materials 1. 2. 3. 4. 5.

C.

Check receiving and handling process prior to cooking. See if ﬁrm discards all dead crabs prior to cooking. If not, estimate percentage of dead crabs utilized. Note any rodent or insect activity in the receiving area. If the ﬁrm refrigerates the live crabs prior to cooking, see if they are kept in a separate cooler from the processed crabs. Check results of any testing of incoming crabs including bacteriological results and pesticides.

Manufacturing Process

To evaluate the sanitation of the manufacturing process, check on the following areas. 1. Cooking Check product ﬂow and determine time and temperature of cooking and type of cooker: 1. 2. 3. 4.

Retort. Live Steam. Check boiler compound used. Review recording charts for retorts. Determine venting procedures.

2. Cooling Check time and temperature relationship and 1. 2. 3. 4. 5.

How long cooked crabs are held at room temperature Any processing delays between cooking, cooling, and picking Whether cooled crabs are refrigerated until picked Whether cooked crabs are stored in same baskets as cooked in or are transferred to another container If refrigerator is used for storing cooled crabs, it is used only for this purpose

3. Picking Check on the following sanitation aspects: 1. 2.

Is picking table cleaned and sanitized prior to use, at appropriate times during the day, and at the end of the day. If the picking table is not cleaned and sanitized between each new supply of

© 2003 by Marcel Dekker, Inc.

3. 4.

5. 6.

crabs, are all crabs on the table picked prior to the addition of new crabs. Check handling of crab claws prior to picking. Pickers hands for cuts, sores, etc. That picking utensils are of proper construction. a. See if all metal knives without wooden handles are used. b. Check to see that the workers do not wrap the handles of the knives with paper towels, cloth, or string. c. See if all stainless steel or other metal shovels with steel handles and shafts are used for placing the crabs onto the picking table. Check shovel storage and see whether it is used for anything besides crabs. If claws are picked mechanically, obtain procedure and check operation. Check on how often pickers deliver the picked meat to the packing room.

4. Packing 1. See if picked crab meat is placed directly into the can or into holding pans. If the crab is ‘‘deboned’’ prior to packing, check on how long it is held. 2. See if weighed crabmeat weighed into ﬁnal cans is closed and iced at frequent intervals. Determine if pickers do their own weighing and ﬁnal packing. 3. Check on how ﬁnished packaged crab meat is stored or if it is shipped the same day it is packaged. 4. See if ice used is from an approved source. Check storage of ice. 5. Pasteurization 1. 2. 3. 4.

Check the can closing system and can handling prior to pasteurization. Check time/temperature of pasteurization process. Check on how pasteurized cans are cooled and stored. See if the ﬁnished canned crabmeat is stored in a refrigerator prior to shipping and how long it is held prior to shipment. 5. Determine shipping operation: refrigerated trucks, iced baskets, etc. 6. Lighting, Ventilation, Refrigeration, Equipment 1. Determining if building is adequately lighted and ventilated. 2. Check if the cooling and refrigerating facilities are adequate to do the job. 3. See if equipment is of proper construction. D. Overall Sanitation 1. See if the building provides for a separation of the various processes. 2. See if building is so constructed to be free from rodent or insect entry points or harborages and whether there are rodents or insects in plant. 3. Check if product contact surfaces (tables, carts, pans, knives, etc.) are of proper construction. See if seams are sealed to avoid product build-up. 4. Obtain in detail the ﬁrm’s plant and equipment cleaning and sanitizing procedures and check if all equipment is cleaned and sanitized as necessary. 5. Determine if employee toilets and hand washing facilities are provided, maintained, and supplied and if handwashing facilities are located in various areas. 6. Determine if hand sanitizing solutions are provided at appropriate locations, maintained at proper levels at all times, and used when necessary. Check hand © 2003 by Marcel Dekker, Inc.

7. 8. 9. E.

sanitizing solution strength at various intervals during the inspection. Check to see if employees use hand dips when necessary. Evaluate the ﬁrm’s operations and employee practices for compliance with the human food (sanitation) GMPRs (21 CFR 110 and the Food Code). Document any insanitary conditions noted that could lead to the contamination of the ﬁrm’s crabs or crabmeat with ﬁlth and/or bacteria. Check storage and disposal of solid waste, e.g., shells.

Check List For Crustacea Processor

Use the following table to obtain the information necessary to make a valid assessment of the sanitation of a processor’s operation.

Stage

Assessment

Receiving (unload)

Sorting

Age Peeling (mechanical), types (Model A) (PCA-1.5″ cook) (choice for freezing) Washers

Shaker-blower (options) In-house inspection

Size graded (machine or manual) Package (cans or plastic)

Freeze

1. Determination of condition (acceptable or decomposed) 2. Separation work area 1. Removal of miscellaneous species of incidental ﬁsh 2. Further determination of condition (quality) 1. Sanitation 2. Time/temperature 1. Sanitation 2. Potable water 3. Separate work area (for peeling, washers, separators, and if applicable shaker-blower) 1. Sanitation 2. Portable water 3. Shell and debris removal (quality) 1. Sanitation 2. Shell removal (quality) 1. Sanitation 2. Shell removal 3. Separate work area for freezing Sanitation Sanitation Personnel sanitation Suitable packaging materials Time/temperature Separate work area Time/temperature (quality)

VI. SCALLOPS A.

Background Information

The scallop industry encompasses three primary species: (1) sea scallops, (2) bay scallops, and (3) calico scallops. © 2003 by Marcel Dekker, Inc.

The processing of sea scallops is accomplished on board the vessel actually harvesting the product. Boats which process sea scallops remain at sea from 3–12 days depending on area and catch. In most cases, the calico scallops are harvested daily and processed at shore processing plants rather than on board the vessel. The trend, however, is toward on-board processing for this species also. Bay scallops pose a unique problem in that they may be processed in a commercial plant or at home. B. Sanitation Critical Factors During the evaluation of food plant sanitation, use the following critical factors: 1. Check for evidence of contamination from rodents, insects, birds, or from domestic animals. 2. Determine if equipment is washed and sanitized about every 2 hrs. 3. Check for time/temperature abuses which could cause rapid bacterial growth and/or decomposition. 4. Determine if employee practices preclude the addition of contaminants. Check for clean dress and proper use of 100 ppm chlorine equivalent hand sanitizers. 5. Determine method of icing or freezing of the scallops. 6. Ascertain if incoming scallops are tested for bacterial load, decomposition, pesticides, etc. Review results of these tests. 7. Check usage of pesticides and rodenticides by ﬁrm to ascertain that they do not become incidental food additives. C. Raw Materials Determine the following: 1. Geographical area where the scallops are harvested 2. Type of scallops harvested and processed by common or species name 3. How scallops are handled between harvesting and processing D. Processing 1. Observe in detail the scallop processing operation. Make a ﬂow plan. 2. Check shucking and evisceration process, to see if this process is physically separated from the packaging and other operations. 3. Determine source of water used in the scallop washing and rinsing operations. If treated by the processor, determine nature and extent of treatment. 4. See if equipment used in processing operation is of proper construction and design. 5. Check ﬁrm’s cleaning and sanitizing operation. 6. Determine time and temperature of processing operation by checking a. How long between harvest and chucking and the temperature of the scallops b. How long scallops are held at ambient air temperature and determine the ambient temperature c. How long between shucking and rinsing and the temperature of the scallops © 2003 by Marcel Dekker, Inc.

d.

7. 8. 9. 10. E.

After being iced, how long before scallops reach an internal temperature below 40°F Check ﬁnished product packaging. Determine source of ice used in icing operation and, if bagged ice is used, source and type of bag, condition of bags, conditions of storage. Check ﬁnished product storage facilities and condition. Check on the use of any food additives to determine if used at allowable levels.

Overall Sanitation 1. 2. 3. 4. 5. 6. 7. 8.

See if building or vessel is free from rodent or insect activity. Check that toilets and hand washing facilities provided are properly located and maintained. Determine strength and type of hand sanitizing solutions used and the sanitizer’s location. Note any employee practices that could lead to the contamination of the scallops with ﬁlth and/or bacteria. See if water and ice used in the process is from an approved source and list source. Determine method of shell and waste material disposal. Evaluate the ﬁrm’s operation for compliance with the human foods (sanitation) CGMPRs (21 CFR 110 and the Food Code). Document any insanitary conditions noted which could lead to the contamination of this ﬁrm’s products with ﬁlth and/or bacteria.

VII. SHRIMP A.

Sanitation Critical Factors

Breading of shrimp has long posed a problem from an economic standpoint. In addition, the time/temperature abuses present a great potential for food poisoning organisms. The growing scarcity and consequential high value of the raw material make the breading standards even more important. Review breaded shrimp standards (21 CFR 161) prior to evaluating plant sanitation. During a sanitation assessment, use critical factors as follows: 1. 2. 3. 4. 5. 6. 7.

Check for the presence of cats, dogs, birds, or vermin in the plant. Review testing of incoming shrimp. Check results of tests for decomposition, bacterial load, pesticides, and other possible adulterants. Evaluate operation for compliance with 21 CFR 12.1 (Raw Breaded Shrimp). Watch for any time/temperature abuses in the handling of seafood. Determine that employee hygienic practices are satisfactory, e.g., clean dress, washing of hands, and use of 100 ppm chlorine equivalent hand sanitizers. Note any equipment defects which cause seafood to lodge, decompose, then dislodge into the pack. Observe breading operations for suspected excesses (12 CFR 161.175/6) or lack of coolant to keep batter mix below 50°F in an open system and below 40°F in closed system.

© 2003 by Marcel Dekker, Inc.

Note the misuse of pesticides, abuse of color or food additives, deviations from standards, etc. B. Raw Materials: Receipt and Storage Determine if 1. Shrimp and other raw materials are inspected upon receipt for decomposition, microbial load, pesticides, and ﬁlth. 2. Raw materials susceptible to microbial contamination are received under a supplier’s guarantee. Raw material speciﬁcations exist and only wholesome raw materials are accepted into active inventory. Determine disposition of rejected raw materials. 3. Shrimp receiving and storage facilities are physically adequate. 4. Frozen shrimp are stored at 0°F (⫺18°C) or below. 5. Fresh or partially processed shrimp are iced or otherwise refrigerated to maintain a temperature of 40°F (4°C) or below until they are ready to be processed. 6. Decomposed shrimp are being processed as follows: a. Examine shrimp as received, and again after sorting, for decomposition. Classify as passable (class 1), decomposed (class 2), or advanced decomposition (class 3). Less experienced inspectional personnel should submit some of class 2 and class 3 shrimp for conﬁrmation by the laboratory. b. Prompt handling and adequate sorting is necessary to prevent decomposition. Check times and temperatures. c. Where decomposed shrimp are going into canned or cooked/peeled shrimp, collect investigational samples of the ﬁnished pack. Give attention to disposition of loads showing a high percentage of decomposition which cannot be adequately sorted and to disposition of reject shrimp. Make certain that ‘‘bait shrimp’’ is denatured. 7. Fresh raw shrimp are washed and chilled to 40°F (4°C) or below within two hours of receipt. Frozen shrimp should be held at 0°F (⫺18°C) or below. Determine if they are examined organoleptically when received. 8. Peeled and deveined shrimp are promptly chilled to 40°F (4°C) or below. C. Plant Sanitation Determine if 1. The water (ice) is a. From an approved source b. Disinfected and contains residual chlorine c. Sampled and analyzed for contamination d. Handled in a sanitary manner 2. Drainage facilities are adequate to accommodate all seepage and wash water. 3. The plant has readily cleanable ﬂoors which are sloped and equipped with trap drains. 4. The plant is free of the presence of vermin, dogs, cats, or birds. 5. The screening and ﬂy control is adequate. 6. Offal, debris, and refuse is placed in covered containers and removed at least daily or continuously. © 2003 by Marcel Dekker, Inc.

7. Adequate hand-washing and sanitizing facilities are located in processing area and are easily accessible to the preparation, peeling, and subsequent processing operations. 8. Signs are posted directing employees handling shrimp and other raw materials to wash and sanitize their hands after each absence from the work station. 9. Employees actually wash and sanitize their hands as necessary (before starting work, after absences from the work station, when hands become soiled, etc.). 10. Hand sanitizing solutions are maintained at 100 ppm available chlorine or the equivalent and are used. 11. Persons handling food or food contact surfaces wear clean outer garments, maintain a high degree of personal cleanliness, and conform to good hygienic practices. 12. Management prevents any person known to be affected with boils, sores, infected wounds, or other sources of microbiological contamination from working in any capacity in which there is a reasonable possibility of contaminating the food. 13. The product is processed to prevent contamination by exposure to areas involved in earlier processing steps, refuse, or other objectionable conditions or areas. 14. Food contact surfaces are constructed of metal or other readily cleanable materials. 15. Seams are smoothly bonded to prevent accumulation of shrimp, shrimp material, or other debris. 16. Each freezer and cold storage compartment used for raw materials and inprocess or ﬁnished product is ﬁtted with required temperature-indicating devices. 17. Unenclosed batter application equipment is ﬂushed and sanitized at least every 4 hr during plant operations and all batter application equipment is cleaned and sanitized at the end of and the beginning of the day’s operation. 18. Breading application equipment and utensils are thoroughly cleaned and sanitized at the end of the day’s operation. 19. Utensils used in processing and product contact surfaces of equipment are thoroughly cleaned and sanitized at least every 4 hr during operation. 20. All utensils and product contact surfaces excluding breading application equipment and utensils are rinsed and sanitized before beginning the day’s operation. 21. Containers used to convey or store food are handled in a manner to preclude direct or indirect contamination of the contents. 22. The nesting of containers is prohibited. D.

Processing

Determine if 1. Raw frozen shrimp are defrosted at recommended temperatures [air defrosting at 45°F (7°C) or below, or in running water at 70°F (21°C) or below in less than 2 hr]. 2. Fresh raw shrimp are washed in clean potable water and chilled to 40°F (4°C) or below. 3. Fresh shrimp are adequately washed, culled, and inspected.

© 2003 by Marcel Dekker, Inc.

4. Every lot of shrimp that has been partially processed in another plant, including frozen shrimp, is inspected for wholesomeness and cleanliness. 5. Shrimp entering thaw tank are free from exterior packaging material and substantially free of linear material. 6. On removal from thaw tank shrimp are washed with a vigorous potable water spray. 7. Shrimp are removed from thaw tank within 30 min after they are thawed. 8. During the grading, sizing, or peeling operation the (1) equipment is cleaned and sanitized before use; (2) water is maintained at proper chemical strength and temperature; and (3) raw materials are protected from contamination. 9. Sanitary drainage is provided to remove liquid waste from peeling tables. 10. Firm prohibits the practice of salvaging shrimp (i.e., repicking the accumulated hulls and shells for missed shrimp or shrimp pieces). 11. Peeled and deveined shrimp are promptly chilled to 40°F (4°C) or below. 12. Peeled shrimp are transported from peeling machines or tables immediately or, if containerized, within 20 min. 13. Peeled shrimp containers, if applicable, are cleaned and sanitized as often as necessary, but in no case less frequently than every 3 h. 14. When a peeler is absent from the duty post, the container is cleaned and sanitized prior to resuming peeling. 15. Peeled shrimp that are transported from one building to another are properly iced or refrigerated, covered and protected. 16. Shrimp are handled minimally and protected from contamination. 17. Shrimp which drop off processing line are discarded or reclaimed. 18. Shrimp are washed with a low-velocity spray or in unrecirculated ﬂowing water at 50°F (10°C) or below just prior to the initial batter or breading application, whichever comes ﬁrst, except in cases where a predust application is included in the process. 19. Removal of batter or breading mixes or other dry ingredients from multiwalled bags is accomplished in an acceptable manner. 20. Batter in enclosed equipment is assured a temperature of not more than 40°F (4°C) and disposed of at the end of each work day, but in no circumstances less often than every 12 hr. 21. Batter in an unenclosed system is maintained at or below 50°F (10°C) and disposed of at least every 4 hr and at the end of the day’s operation. 22. Breading reused during a day’s operation is sifted through a 0.5 in. or smaller mesh screen. 23. Breading remaining in the breading application equipment at the end of a day’s operation is reused within 20 hr and is sifted as mentioned and stored in a freezer in a covered sanitary manner. 24. Hand batter pans are cleaned, sanitized, and rinsed between each ﬁlling with batter or breading. E.

Finished Product Process and Quality Assurance

Determine if 1. Processing and handling of ﬁnished product is (1) performed in a sanitary manner, (2) protected from contamination, and (3) arranged to facilitate rapid freezing.

© 2003 by Marcel Dekker, Inc.

2. Manual manipulation of breaded shrimp is kept to a minimum. 3. Aggregate processing time, excluding the time required for thawing frozen material, is less than 2 hr, exclusive of iced or refrigerated storage time. 4. Breaded shrimp are placed into freezer within 30 min of packaging. 5. Breaded shrimp are frozen in a plate or blast freezer at ⫺20°F (⫺29°C) or below. 6. Storage freezer is maintained at or below 0°F (⫺18°C). 7. In-line, environmental, and ﬁnished product samples are analyzed and evaluated at least weekly for microbial conditions. Review these analytical records, if available. 8. Firm has established microbiological speciﬁcations for the ﬁnal product. If so, review and report these speciﬁcations. 9. Firm withholds from distribution lots which do not meet their established microbiological standards. 10. Finished product is handled and stored in a manner which precludes contamination. 11. Labels bear a cautionary statement to keep product frozen. VIII. SMOKED FISH A.

Sanitation Critical Factors

During an evaluation of the sanitation of a smoking ﬁsh operation, use critical factors as follows: 1.

2. 3. 4. 5. 6.

7.

B.

Check sanitary conditions under which ﬁrm is operating, including any evidence of insanitation and contamination associated with insects, rodents, microorganisms, chemicals, or other possible sources. Check raw material and packaging material storage areas as well as other susceptible locations in the plant. Review raw material receiving records for DDT and other pesticides, decomposition, and bacteriological quality. Check food and color additives to ascertain that they are allowed for use and are being used properly. Observe employee practices to make sure that they are not acting as routes of contamination. Ascertain if the various operations including raw material receipt and storage, defrosting, brining, etc., are acceptable. Review recording charts to ascertain what times/temperatures of smoking have been, which may vary depending on the desired salt content the ﬁrm is trying to achieve. Check ﬁnished stored product (i.e., any smoked chubs in which nitrite is used) to ascertain the internal temperature based on the time since smoking. (Temperature within 3 hr of cooking and again within 12 hr of cooking.)

Plant Sanitation and Facilities 1. 2.

Check method(s) for cleaning and sanitizing utensils, conveyors, smoking racks, and other food-contact surfaces used in daily operations. Check the strength and adequacy of hand sanitizing and equipment sanitizing

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solutions. The minimum effective chlorine concentration for hand sanitizing solutions is 100 ppm and for equipment sanitizing solutions is 200 ppm. Iodine solutions should be 15 ppm for hand sanitizing solutions and 25 ppm for equipment sanitizing solutions. Determine if maintained at proper levels. 3. Determine method used to separate ﬁnished product cooling, packaging, and storage areas from the uncooked product and processing areas. 4. Determine the adequacy of plant waste disposal operations. 5. Check if hand washing, toilet, and sanitizing facilities have been provided and that signs have been posted directing the employees to wash and sanitize hands following use. C. Raw Materials Determine the following: 1. Source (area and distributor) and species of ﬁsh processed by the ﬁrm including the type selected for full coverage during this inspection. 2. Process condition in which bulk ﬁsh is supplied (e.g., fresh, frozen, mild cured, brined, etc.). 3. Quality of ﬁsh received. Organoleptic examination should be performed and results reported. 4. Raw ﬁsh handling procedures (e.g., defrosting, draining procedures encountered). 5. Available chlorine or iodine concentrations in hand dip or equipment sanitizing solutions, if used. 6. Time/temperature intervals for each step in the raw ﬁsh handling operations. 7. If incoming ﬁsh are sampled and analyzed for the presence of DDT and other pesticides. D. Processing 1. Salting and Brining Determine the following: 1. Size of ﬁsh or pieces of ﬁsh brined noting variations of ﬁsh size and sizing procedures. 2. Form and grade of salt (NaCl) used in the brining. 3. Ratio of brine to ﬁsh. Determine actual or near estimates of weight of salt, volume of water, and weight of ﬁsh being brined. 4. Concentrations of brine (NaCl) solutions in degrees Salinometer at the initiation of brining, during brining, and at the conclusion of the brining operation. A reduction in salt concentration in the brining solution after brining may indicate salt uptake by the ﬁsh during brining. (Caution: if Salinometers are made of glass, the degree of salinity should be read in a plastic graduate. Do not put the salinometer directly into the tank with ﬁsh. It could break and contaminate the ﬁsh with glass.) 5. Times/temperatures of brining solutions at different intervals during the brining process. Include total brining time. © 2003 by Marcel Dekker, Inc.

6.

Method of agitation of brine solution during brining, if employed, noting number of times agitated and length of each agitation.

2. Heating, Cooking, and Smoking Operation 1.

2.

Check equipment used during heating, cooking, and smoking operation. Include oven type, source of heat, type of smoke generators, product temperature monitoring equipment, humidity regulators, etc. (Temperature recording devices should have an accuracy of ⫾2°F.) Determine the methods and procedures used in drying, cooking, and smoking. Include time/temperature data, results of temperature monitoring by the ﬁrm, location of the temperature probes, and product rotation practices.

3. Cooling 1. 2. 3.

4.

Monitor time/temperature relationship during cooling to determine how long it takes to reach an internal temperature of 38°F. Determine method of cooling. Check observable procedures and conditions which can contribute to the microbiological contamination of the processed ﬁsh. Include observations such as extended cooling time and optimal incubation temperature, exposed to airborne contamination, improper handling, or poor in-process storage conditions. Determine if ﬁrm separates cooling facilities from raw processing and cooking operations.

4. Packaging Determine method and types of packing including: 1. 2. 3.

E.

Storage and Distribution 1. 2. 3.

F.

Time/temperature relationship during packaging. Any use of additives or prepackaging additive treatment. Include name and quantity added, method of application, etc. Observable practices and conditions which can contribute to the microbiological contamination of the processed ﬁsh. Include lack of required facilities, excessive product handling, improper storage, etc.

Check type of equipment used for determining, recording, and maintaining storage temperatures. Determine actual storage compartment temperatures. Refrigerated storage temperatures should be 38°F or below. Determine method of distribution (e.g., refrigerated, iced, frozen, etc.).

Laboratory Controls

Check or determine the following: 1.

2.

Method and frequency of sampling. Identify salinity testing operations and evaluate testing procedures and frequency. Describe microbiological testing of processed ﬁsh, how often, methods used, adequacy of testing, etc. Checks made on in-process controls and laboratory equipment.

© 2003 by Marcel Dekker, Inc.

3. Use of outside laboratories, consultants, etc. Include name, location, and tests each ﬁrm performs and how often tests are conducted. 4. Results of analysis from previous lots. G.

Overall Sanitation 1. Evaluate the ﬁrms operation for compliance with 21 CFR 110 (GMPRs for human foods sanitation). 2. Evaluate the ﬁrm’s cleaning and sanitizing procedures. 3. Check if adequate hand washing and sanitizing facilities are provided and if signs directing their use are provided. Evaluate employee use of hand dips and if they are used when necessary. 4. See if hand dips and equipment sanitizing solutions are maintained at the proper level and changed when necessary.

ACKNOWLEDGMENT Most data provided in this chapter have been modiﬁed with permission from documents prepared by Science Technology System, West Sacramento, CA.

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33 Retail Foods Sanitation: Prerequisites to HACCP PEGGY STANFIELD Dietetic Resources, Twin Falls, Idaho, U.S.A.

I.

BACKGROUND

When we talk about retail food protection, we include many categories of business that deal with food, e.g., restaurants, cafeterias (schools, prisons, hospitals), public eating places (fairgrounds, events), and so on. As far as health agencies are concerned, delis, grocery stores, etc., are also considered as retail food businesses. There is no doubt that eventually all large restaurants and cafeterias will be required to implement a hazard analysis and critical control point (HACCP) system. Before it can be implemented, most state regulatory agencies want to make sure that all such food service establishments have in place safety programs that serve as the foundation or prerequisites to a workable HACCP program. This chapter discusses such fundamental safety practices and how they can eventually be incorporated into a sound HACCP program. The data have been modiﬁed from: A HACCP Principles Guide for Operators of Food Establishments at the Retail Level [DRAFT]. Food and Drug Administration: April 15, 1998. The discussion for this chapter will be much facilitated by referring to the glossary of terms frequently mentioned provided in the next section and taken from the Food Code. II. GLOSSARY Approved source Acceptable to the regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health. Bacteria Living single-cell organisms, bacteria can be carried by water, wind, insects, plants, animals, and people and survive well on skin and clothers and in © 2003 by Marcel Dekker, Inc.

human hair. They also thrive in scabs, scars, the mouth, nose, throat, intestines, and room-temperature foods. CCP Critical control point Contamination The unintended presence in food of potentially harmful substances, including microorganisms, chemicals and physical objects. Cross-contamination The transfer of harmful substances or disease-causing microorganisms to food by hands, food-contact surfaces, sponges, cloth towels, and utensils that touch raw food, are not cleaned, and then touch ready-to-eat foods. Cross-contamination can also occur when raw food touches or drips onto cooked or ready-to-eat foods. Corrective action An activity that is taken by a person whenever a critical limit is not met. Critical control point (CCP) An operational step or procedure in a process, production method, or recipe, at which control can be applied to prevent, reduce, or eliminate a food safety hazard. Critical limit A measurable limit at a CCP that can be monitored to control the identiﬁed hazard to a safe level in the food. Fish 1. Fresh or saltwater ﬁnﬁsh, crustaceans, and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyﬁsh, sea cucumber, sea urchin, and the roe of such animals), other than birds or mammals, and all mollusks, if such life is intended for human consumption. 2. Includes an edible human food product derived in whole or in part from ﬁsh, including ﬁsh that have been processed in any manner. Food Raw, cooked, or processed edible substance, ice, beverage, chewing gum, or ingredient used or intended for use or for sale in whole or in part for human consumption. Food establishment An operation at the retail level, i.e., that serves or offers food directly to the consumer and that, in some cases, includes a production, storage, or distributing operation that supplies the direct-to-consumer operation. Foodborne illness Sickness resulting from acquiring a disease that is carried or transmitted to humans by food containing harmful substances. Foodborne outbreak The occurrence of two or more people experiencing the same illness after eating the same food. HACCP Hazard analysis and critical control points. HACCP plan A written document based on the principles of HACCP and describes the procedures to be followed to ensure the control of a speciﬁc process or procedure. HACCP system The result of implementing the HACCP principles in an operation that has a foundational, comprehensive, prerequisite program in place. A HACCP system includes the HACCP plan and all standard operating procedures (SOPs). Hazard A biological, physical, or chemical property that may cause a food to be unsafe for human consumption. Internal temperature The temperature of the internal portion of a food product. Meat The ﬂesh of animals used as food including the dressed ﬂesh of cattle, swine, sheep, or goats and other edible animals, except ﬁsh, poultry, and wild game animals. © 2003 by Marcel Dekker, Inc.

Microorganism A form of life that can be seen only with a microscope; includes bacteria, viruses, yeast, and single-celled animals. Molluscan shellﬁsh Any edible species of raw, fresh, or frozen oysters, clams, mussels, and scallops, or edible portions thereof, except when the scallop product consists only of the shucked adductor muscle. Monitoring The act of observing and making measurements to help determine if critical limits are being used and maintained. National Shellﬁsh Sanitation Program (NSSP) The voluntary system by which regulatory authorities for shellﬁsh harvesting waters and shellﬁsh processing and transportation and the shellﬁsh industry implement speciﬁed controls to ensure that raw and frozen shellﬁsh are safe for human consumption. NSSP National Shellﬁsh Sanitation Program. Operational step An activity in a food establishment, such as receiving, storage, preparation, cooking, etc. Parasite An organism that grows, feeds, and is sheltered on or in a different organism and contributes to its host. Pathogen A microorganism (bacterium, parasite, virus, or fungus) that is infectious and causes disease. Personal hygiene Individual cleanliness and habits. Potentially hazardous food A food that is natural or synthetic and that requires temperature control because it is capable of supporting one of the following: 1. The rapid and progressive growth of infectious or toxigenic microorganisms 2. The growth and toxin production of Clostridium botulinum 3. In raw shell eggs, the growth of Salmonella enteritidis Potentially hazardous food includes foods of animal origin that are raw or heat treated; foods of plant origin that are heat treated or consist of raw seed sprouts; cut melons; and garlic and oil mixtures that are not acidiﬁed or otherwise modiﬁed at a processing plant in a way that results in mixtures that do not support growth of pathogenic microorganisms as described. Procedural step An individual activity in applying the HACCP plan to a food establishment’s operations. Process approach A method of categorizing food operations into one of three modes: 1. Process 1: food preparation with no cook step wherein ready-to-eat food is stored, prepared, and served 2. Process 2: food preparation for same day service wherein food is stored, prepared, cooked, and served 3. Process 3: complex food preparation wherein food is stored, prepared, cooked, cooled, reheated, hot held, and served. Ready-to-eat food 1. A food that is in a form that is edible without washing, cooking, or additional preparation by the food establishment or consumer and that is reasonably expected to be consumed in that form. 2. Ready-to-eat food includes potentially hazardous food that has been © 2003 by Marcel Dekker, Inc.

cooked; raw, washed, and cut fruits and vegetables; whole, raw fruits and vegetables that are presented for consumption without the need for further washing, such as at a buffet; and other food presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks, or shells have been removed. Record A documentation of monitoring observation and veriﬁcation activities. Regulatory authority A federal, state, local, or tribal enforcement body or authorized representative having jurisdiction over the food establishment. Risk An estimate of the likely occurrence of a hazard. SOP Standard operating procedure. Shellﬁsh Bivalve molluscan shellﬁsh. Standard operating procedure (SOP) A written method of controlling a practice in accordance with predetermined speﬁcations to obtain a desired outcome. Temperature measuring device A thermometer, thermocouple, thermistor, or other device for measuring the temperature of food, air, or water. Toxin A poisonous substance that may be found in food. Veriﬁcation The use of methods, procedures, or tests by supervisors, designated personnel, or regulators to determine if the food safety system based on the HACCP principles is working to control identiﬁed hazards or if modiﬁcations need to be made. Virus A protein-wrapped genetic material which is the smallest and simplest life form known (e.g., hepatitis A). III. PREREQUISITE PROGRAMS A.

Food Code

The provisions of the Food Code provide a foundation on which to develop a food safety system based upon the principles of HACCP. Major interventions in the Food Code are demonstration of knowledge by the person in charge, employee health, no bare-hand contact with ready-to-eat food, time and temperature control, and the use of a consumer advisory regarding the consumption of raw or undercooked animal foods. There interventions need to be addressed within the overall food safety program, which may entail inclusion in standard operation procedures (SOPs) that can be considered as one major frame of reference of sanitation and HACCP. B.

Standard Operation Procedures

1. Introduction Many provisions of the Food Code address the design of food establishments and equipment as well as acceptable operational practices. Adherence to design criteria and development of SOPs affects the food preparation environment. Both are considered prerequisites to the development of food safety systems based upon the HACCP principles. The SOPs specify practices to address general hygiene and measures to prevent food from becoming contaminated due to various aspects of the food environment. When SOPs are in place, HACCP can be more effective because it can concentrate on the hazards associated with the food and its preparation and not on the food preparation facility. The SOPs speciﬁc to your operation describe the activities necessary to complete © 2003 by Marcel Dekker, Inc.

tasks that accomplish compliance with the Food Code, are documented as a written reference, and are used to train the staff who are responsible for the tasks. Three purposes for establishing SOPs for your operation are to protect your products from contamination from microbial, chemical, and physical hazards; to control microbial growth that can result from temperature abuse; and to ensure procedures are in place for maintaining equipment. Standard operating procedures ensure that 1. Product is purchased from approved suppliers/sources. 2. The water in contact with food and food-contact surfaces and used in the manufacture of ice is potable. 3. Food-contact surfaces, including utensils, are cleaned, sanitized, and maintained in good condition. 4. Uncleaned and nonsanitized surfaces of equipment and utensils do not contact raw or cooked ready-to-eat food. 5. Raw animal foods do not contaminate raw or cooked ready-to-eat food. 6. Toilet facilities are accessible and maintained. 7. Hand washing facilities are located in food preparation, food dispensing, and warewashing areas and immediately adjacent to toilet rooms, and are equipped with hand cleaning preparations and single-service towels or acceptable hand drying devices. 8. An effective pest control system is in place. 9. Toxic compounds are properly labeled, stored, and safely used. 10. Contaminants such as condensate, lubricants, pesticides, cleaning compounds, sanitizing agents, and additional toxic materials do not contact food, food packaging material, or food-contact surfaces. 11. Food, food packaging materials, and food-contact surfaces do not come in contact with and are not contaminated by physical hazards such as broken glass from light ﬁxtures, jewelry, etc. 2. Standard Operating Procedures to Control Contamination of Food Procedures must be in place to ensure that proper personnel health and hygienic practices are implemented, including 1. Restricting or excluding workers with certain symptoms such as vomiting or diarrhea 2. Practicing effective hand washing 3. Restricting eating, smoking, and drinking in food preparation areas 4. Using hair restraints 5. Wearing clean clothing 6. Restricting the wearing of jewelry 3. Microbial Growth Control These procedures ensure that all potentially hazardous food is received and stored at a refrigerated temperature of 41°F (5°C) or below. Note that the Food Code makes some allowances for speciﬁc foods that may be received at higher temperatures. 4. Equipment Maintenance These procedures ensure that 1. Temperature measuring devices (e.g., thermometer or temperature recording device) are calibrated regularly. © 2003 by Marcel Dekker, Inc.

2.

3.

4.

C.

Cooking and hot holding equipment (grills, ovens, steam tables, conveyor cookers, etc.) are routinely checked, calibrated if necessary, and operating to ensure correct product temperature. Cooling equipment (refrigerators, rapid chill units, freezers, salad bars, etc.) are routinely checked, calibrated if necessary, and operating to ensure correct product temperature. Warewashing equipment is operating according to manufacturer’s speciﬁcations.

The Flow of Food

The ﬂow of food, which is the path that food follows from receiving through serving, is important for determining where potentially signiﬁcant food safety hazards may occur. At each operational step in the ﬂow, active management of food preparation and processes is an essential part of business operations. With a HACCP system, you set up control measures to protect food at each stage in the process. The examples of food processes listed are not intended to be all inclusive. For instance, quick-service, full-service, and institutional providers are major types of food service operations. Each of these has its own individual food safety processes. These processes are likely to be different for a deli in a retail food store. Some operations may have all three types of processes or variations of the three. Identifying the food process ﬂows speciﬁc to your operations is an important part of providing a framework for developing a food safety management system. 1. Food Process with No Cook Step: Receive–Store–Prepare– Hold–Serve As mentioned, the important feature of this type of process is the absence of a cooking step. Heating foods destroys bacteria, parasites, and viruses and is often a CCP. But since this particular food ﬂow does not include cooking, there is no step that will eliminate or kill bacteria, parasites, or viruses. An example is tuna salad that is prepared and served cold. Control in this process will focus on preventing 1. 2.

3. 4. 5.

Bacterial growth (e.g., storage under refrigeration) Contamination from employees (e.g., restriction of employees ill with diarrhea, proper hand washing, preventing bare-hand contact with ready-to-eat foods, etc.) Cross-contamination from other foods (e.g., raw to ready-to-eat) Cross-contamination from soiled equipment (e.g., cleaning and sanitizing) Obtaining foods from approved sources (e.g., a supplier of raw ﬁsh or sushi who adequately freezes ﬁsh to control parasites)

You should also think about some other factors, including 1. 2. 3. 4. 5. 6.

Are there any ingredients or menu items of special concern? (See Food Code.) Is this a potentially hazardous food requiring speciﬁc temperature controls? How willit be served? Immediately? On a buffet? Does this food have a history of being associated with illnesses? Will this require a great deal of preparation, making preparation time, employee health, and bare-hand contact with ready-to-eat food a special concern? How will an employee ill with diarrhea be restricted from working with food?

© 2003 by Marcel Dekker, Inc.

7. Are you serving food to a population that is known to be highly susceptible to foodborne illness (e.g., residents of health care facilities, persons in child or adult day care facilities, etc.)? 2. Food Preparation for Same-Day Service: Receive–Store–Prepare– Cook–Hold–Serve In this process, a food is prepared and served the same day. The food, such as chili, will be cooked and held hot until service. Generally, the food will pass through the temperature danger zone only once before it is served to the customer, thus minimizing the opportunity for bacterial growth. The preparation step may involve several processes, including thawing a frozen food, mixing in other ingredients, or cutting or chopping. It is important to remember that added ingredients may introduce additional contaminants to the food. Cutting or chopping must be done carefully so that cross-contamination from cutting boards, utensils, aprons, or hands does not occur. Control points at this operational step include good sanitation and hand washing. During cooking, food will be subjected to hot temperatures that will kill harmful bacteria, parasites, and viruses that might be introduced before cooking, making cooking a CCP. It is the operational step where raw animal foods are made safe to eat, and, therefore, time and temperature measurement is very important. Temperature of foods during hot holding must be maintained until service so that harmful bacteria do not survive and grow. 3. Complex Processes: Receive–Store–Prepare–Cook–Cool–Reheat– Hot Hold–Serve Failure to adequately control food product temperature is the one factor most commonly associated with foodborne illness. Foods prepared in large volumes or in advance for nextday service usually follow an extended process ﬂow. These foods are likely to pass through the temperature danger zone several times. The key in managing the operational steps within the process is to minimize the time foods are at unsafe temperatures. In some cases, a variety of foods and ingredients that require extensive employee product preparation may be part of the process. A sound food safety management system will incorporate SOPs for personal hygiene and cross-contamination prevention throughout the ﬂow of the food. Before you set up a management system for your operational steps, there are several factors you should consider. Multiple-step processes require proper equipment and facilities. Your equipment needs to be designed to handle the volume of food you plan to prepare. For example, if you use a process that requires the cooling of hot food, you must provide equipment that will adequately and efﬁciently lower the food temperature as quickly as possible. If you ﬁnd that a recipe is too hard to safely prepare, you may want to consider purchasing pre-prepared items from a reputable source. IV. PROCEDURAL STEPS FOR DESIGNING THE HACCP SYSTEM The most effective way to get started is to use a team approach to design and implement a plan based on the HACCP principles. A team could be comprised of the owner and the chef or cook. Although managers are responsible for designing the system, implementation involves the efforts and commitment of every employee. Education and training of both © 2003 by Marcel Dekker, Inc.

management and employees is important in their respective roles of producing safe foods. You may consider working with outside consultants, university extension services, and regulatory authorities to ensure your HACCP system is based on the best available science and will control identiﬁed hazards. A.

Step 1: Group Menu Items

To get started, review how your menu items ﬂow through your operation—note whether they undergo a cook step for same day serving, receive additional cooling and reheating following a cook step, or have no cook step involved. Refer to the Food Code for organizing your menu items by Processes 1, 2, and 3. Looking at your menu, place each menu item or similar menu items (e.g., hot soups or cold salads) into the appropriate group. You may discover that more than one food process is conducted within your operation. These menu items may pose special hazards that are not always readily apparent. To accomplish the ﬁrst procedural step in developing your food safety management system, identify the food processes speciﬁc to your menu items and categorize your menu items according to one of the three process-speciﬁc lists: Process number 1: Food preparation with no cook step—ready-to-eat food that is stored, prepared, and served. Process number 2: Food preparation for same-day service—food that is stored, prepared, cooked, and served. Process number 3: Complex food preparation—food that is stored, prepared, cooked, cooled, reheated, hot held, and served. See the following table for an example.

Process 1 Salad greens Fish for sushi Fresh vegetables Oysters or clams served raw Tuna salad with Caesar salad dressing Coleslaw Sliced sandwich meats Sliced cheese

B.

Process 2

Process 3

Hamburgers Soup du jour Hot vegetables Entrees for ‘‘special of the day’’ Cooked eggs

Soups Gravies Sauces Large roasts Chili Taco ﬁlling Egg rolls

Step 2: Conduct Hazard Analysis

In developing a food safety system, you need to identify the hazards that exist in the ﬂow of foods in your operation, from receiving to serving Hazards include 1. 2. 3. 4.

Pathogens or toxins present in food when you receive them Pathogens that may be introduced during preparation (e.g., using a raw animal food as one ingredient) Pathogen growth or toxin production during storage, preparation, or holding Pathogens or toxins that survive heating

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5. Contaminants (i.e., pathogens, chemicals, physical objects) that are introduced to food by food workers or equipment Since you have grouped your menu items, including ingredients, into the three processes, you can identify hazards that are associated with each process. You will see that the more complex the process is, the greater are the opportunities for hazards to occur. In consultation with your regulatory authority, you need to identify the hazards associated with various foods and ingredients, such as 1. 2. 3. 4. 5. 6.

Salmonella and Campylobacter jejuni in raw poultry. E. coli O157:H7 in raw ground beef. Staphylococcus aureus toxin formation in cooked ham Bacillus cereus spore survival and toxin formation in cooked rice Clostridium perfringens spore survival and subsequent growth in cooked foods Hazards speciﬁc to seafood (see Food Code)

This list is only a brief sample of hazards associated with speciﬁc foods. By identifying the hazards, you will be able to determine CCPs and critical limits on the worksheet. Another way of fulﬁlling the hazard analysis step is to understand the hazards associated with your speciﬁc menu items and to adhere to the critical limits established in the Food Code. Those critical limits are based on the anticipated hazards. 1. Food Safety Management Worksheets and Summaries Worksheets and summaries for your operational steps enable you to 1. Identify those operational steps in the food ﬂow that are speciﬁc to your operation. 2. Write in your SOPs which are the general procedures that cross all ﬂows and products. 3. Reference the CCPs and critical limits pertaining to those process steps. 4. Develop monitoring procedures and corrective actions which are customized to ﬁt your operation. 5. Consider the type of recordkeeping you need to document that you are controlling signiﬁcant food safety hazards. A HACCP plan allows the ﬂexibility for you to customize a food safety management system speciﬁc to your operations. The worksheets are provided to assist you in developing procedures to 1. 2. 3. 4.

Monitor CCPs. Take corrective actions when critical limits are not met. Establish a veriﬁcation procedure. Establish a recordkeeping system.

Review the following worksheets and the summary page for each operational step. Determine the ones that are applicable to your operation and make copies of them so you can ﬁll in your groupings of menu items (which you did preliminarily in procedural step 1). Then continue to use the forms and complete the information as you work through procedural steps 3 through 9. © 2003 by Marcel Dekker, Inc.

a. Receiving. At receiving, your main concern is contamination from pathogens and the formation of harmful toxins. Obtaining food from approved sources and at proper temperatures are important purchase speciﬁcations for preventing growth and contamination during receiving. Approved sources are suppliers who are regulated and inspected by appropriate regulatory authorities. (See Table 1.) Ready-to-eat, potentially hazardous food is a special concern at receiving. Because this food will not be cooked before service, microbial growth could be considered a signiﬁcant hazard for receiving refrigerated, ready-to-eat foods. Having SOPs in place to control product temperature is generally adequate to control the hazards present at receiving of these products. Besides checking the product temperature, you will want to check the appearance, odor, color, and condition of the packaging. Federal regulations require that processors of seafood and seafood products for interstate distribution have a HACCP plan. These establishments are approved sources for seafood, and you may ask your interstate seafood supplier for documentation that the ﬁrm has a HACCP plan in place. Processors of seafood and seafood products that are sold or distributed only within a state may or may not be required to have a HACCP plan, depending on the state, local, or tribal regulations. Special consideration should be given to certain species of ﬁnﬁsh and raw molluscan shellﬁsh. Molluscan shellﬁsh (oysters, clams, mussels, and scallops) that are received raw in the shell or shucked must be purchased from suppliers who are listed on the FDA Interstate Certiﬁed Shellﬁsh Shippers’ List or on a list maintained by your state shellﬁsh control authority. Shellﬁsh received in the shell must bear a tag (or a label for shucked shellﬁsh) which states the date and location of harvest, in addition to other speciﬁc information. Finﬁsh harvested from certain areas may naturally contain a certain toxin that is not readily apparent. This toxin is called ciguatera. Other ﬁnﬁsh may develop toxins after harvest if strict temperature control is not maintained. This toxin is called scombrotoxin. Temperature control is important at receiving because this toxin cannot be eliminated by cooking. For more information on toxins in reef ﬁnﬁsh, histamine formation in certain species, and parasites in raw ﬁnﬁsh requiring control, refer to the Food Code. b. Storage. When food is in refrigerated storage, your management system should focus on preventing the growth of bacteria that may be present in the product. This is primarily achieved through temperature control. Special attention needs to be given to controlling and monitoring the temperatures of potentially hazardous ready-to-eat foods. (See Table 2.) When determining the monitoring frequency of product storage temperature, it is important to make sure that the interval between temperature checks is established to ensure that the hazard is being controlled and time is allowed for an appropriate corrective action. For example, if you are storing potentially hazardous ready-to-eat foods under refrigeration, you may decide to set a critical limit for the refrigeration units to operate at 41°F (5°C) or below. You may also want to set a target, or operating limit, of 40°F (4.4°C), for example, in order to provide a safety cushion that allows you the opportunity to see a trend toward exceeding 41°F (5°C) and to intervene with appropriate corrective actions. Monitoring procedures for ready-to-eat foods ideally include internal product temperature checks. You need to assess whether it is realistic and practical for you to do this, depending on the volume of food you are storing. You may choose to base your monitoring © 2003 by Marcel Dekker, Inc.

Table 1 Process

Receiving Worksheet Menu item

Hazard

CCP

Critical limits

Process 1

Examples: salads, sushi

Yes or no

Receive at 41°F or below Approves source Seafood HACCP plan Proper chemical storage/ use

Process 2

Examples: hamburgers, mahi-mahi

Yes or no

Process 3

Example: soups

Microbial contamination; bacterial growth; parasites; scombrotoxin, ciguatera, or other toxin contamination; chemical contamination Microbial contamination; bacterial growth; or scombrotoxin, ciguatera, or other toxin contamination; chemical contamination Microbial contamination; bacterial growth; or scombrotoxin, ciguatera, or other toxin contamination; chemical contamination

Receive at 41°F or below Approved source Seafood HACCP plan Proper chemical storage/ use Receive at 41°F or below Approved source Seafood HACCP plan Proper chemical storage/ use

© 2003 by Marcel Dekker, Inc.

Yes or no

Monitoring

Corrective actions

Veriﬁcation

Records

Table 2 Process

Storage Worksheet Menu item

Hazard

CCP

Process 1

Examples: salads, sushi

Bacterial growth, crosscontamination, parasites, chemical contamination

Yes or no

Process 2

Examples: hamburgers, mahi-mahi

Bacterial growth, scombrotoxin, cross-contamination, chemical contamination

Yes or no

Process 3

Example: soups

Bacterial growth, scombrotoxin, cross-contamination, chemical contamination

Yes or no

© 2003 by Marcel Dekker, Inc.

Critical limits Store at 41°F or below Separate raw from ready-to-eat food Freeze ﬁsh to be consumed raw at ⫺4°F for 7 days or ⫺31°F for 15 hr Proper chemical storage/use Store at 41°F or below Separate raw from ready-to-eat food Proper chemical storage/use Storage at 41°F or below Separate raw from ready-to-eat food Proper chemical storage/use

Monitoring

Corrective actions

Veriﬁcation

Records

system on the air temperature of the refrigerated equipment as an SOP. How often you need to monitor the air temperature depends on 1. Whether the air temperature of the refrigerator accurately reﬂects the internal product temperature (remember, your food safety refrigeration temperature must be based on the internal product temperature of the food stored within a refrigeration unit, not the air temperature) 2. The capacity and use of your refrigeration equipment 3. The volume and type of food products stored in your cold storage units 4. The SOPs that support monitoring this process 5. Shift changes and other operational considerations Standard operating procedures can be developed to control some hazards and assist in implementing a food safety system that minimizes the potential for bacterial growth and contamination. The control of cross-contamination can be done by separating raw foods from ready-to-eat products within your operation’s refrigeration and storage facilities. Special consideration should be given to the storage of scombroid ﬁsh due to the potential formation of histamine, a chemical hazard. To control histamine formation in scombroid toxin–forming ﬁsh, it is recommended that storage be a CCP with the critical limit not to exceed 41°F (5°C), as stated in the Food Code, unless you can show through scientiﬁc data that the food safety hazard will not result. c. Preparation. Of all the operational steps in food processes, preparation has the greatest variety of activities that must be controlled, monitored, and in some cases documented. It is impossible to include in this model a summary guide that covers the diversity in menus, employee skills, and facility design that impact the preparation of food. The preparation step may involve several processes, including thawing a frozen food, mixing together several ingredients, cutting, chopping, slicing, or breading. (See Table 3.) At the preparation step, SOPs can be developed to control some hazards and assist in implementation of a food safety system that minimizes the potential for bacterial growth and contamination from employees and equipment. Front-line employees will most likely have the greatest need to work with the food. A well-designed personal hygiene program that has been communicated to all employees will minimize the potential for bacterial, parasitic, and viral contamination. Your program must include instructions to your employees as to when and how to wash their hands. Procedures need to be in place that either eliminate employees’ hand contact with readyto-eat foods or implement an alternative personal hygiene program that provides an equivalent level of control of bacterial, parasitic, and viral hazards. It is also very important to identify and restrict ill employees from working with food, especially if they have diarrhea. Procedures must be in place to prevent cross-contamination from utensils and equipment. Designated areas or procedures that separate the preparation of raw foods from ready-to-eat foods minimize the potential for bacterial contamination. Proper cleaning and sanitizing of equipment and work surfaces are an integral SOP to this operational step. Batch preparation is an important tool for controlling bacterial growth because limiting the amount of food prepared minimizes the time the food is kept at a temperature that allows growth. Planning your preparation ahead assists in minimizing the time food must be out of temperature at this operational step. Batch preparation also breaks the growth cycle of bacteria before they can reach dangerous levels. © 2003 by Marcel Dekker, Inc.

Table 3 Process

Preparation Worksheet Menu item

Hazard

CCP

Critical limits Store at 41°F or below or use time to control growth Separate raw from ready-to-eat food Restrict ill employees; control bare-hand contact Proper chemical storage/ use Store at 41°F or below or use time to control growth Separate raw from ready-to-eat food Restrict ill employees; control bare-hand contact Proper chemical storage/ use Store at 41°F or below or use time to control growth Separate raw from ready-to-eat food Restrict ill employees; control bare-hand contact Proper chemical storage/ use

Process 1

Example: salads

Bacterial growth, crosscontamination, contamination from employees, chemical contamination

Yes or no

Process 2

Examples: hamburgers, mahi-mahi

Bacterial growth, crosscontamination, contamination from employees, chemical contamination

Yes or no

Process 3

Example: soups

Bacterial growth, crosscontamination, contamination from employees, chemical contamination

Yes or no

© 2003 by Marcel Dekker, Inc.

Monitoring

Corrective actions

Veriﬁcation

Records

When thawing frozen foods, maintaining proper product temperature and managing time are the primary controls for minimizing bacterial growth. Procedures need to be in place to minimize the potential for microbial, chemical, and physical contamination during thawing. Use of prechilled ingredients to prepare a cold product, such as tuna salad, will assist you in maintaining temperature control for this process. Special consideration should be given to disallowing bare hand contact in the preparation of ready-to-eat foods. You need to control the introduction of hazards during preparation. How will you accomplish controlling the hazard presented by hand contact with ready-to-eat food? You should review your operation to determine whether this operational step will be controlled as a CCP or an SOP. d. Cooking. This operational step only applies to those foods that you have listed in Processes 2 and 3. Cooking foods of animal origin is the most effective operational step in food processes for reducing and eliminating biological contamination. Hot temperatures will kill most harmful bacteria, and with relatively few exceptions, such as cooking plant foods, this is a CCP. It is at this step that food will be made safe to eat. Therefore, product temperature and time measurements are very important. If the appropriate product temperature for the required amount of time is not achieved, bacteria, parasites, or viruses may survive in the food. (See Table 4.) Critical time and temperature limits vary according to the type of food. Employees should view ensuring proper cooking temperatures as an essential element in producing an acceptable product. A ﬁnal cooking time and temperature chart for speciﬁc foods is included for your review. Simply reference the foods speciﬁc to your food establishment and incorporate the appropriate critical time and temperature limits into your management system. (See Table 5.) You will need to determine the best system for you to use that will ensure that the proper cooking temperature and time are reached. Checking the internal product temperature is the most desirable monitoring method. However, when large volumes of food are cooked, a temperature check of each individual item may not be practical. For instance, a quick service food service operation may cook several hundred hamburgers during lunch. If checking the temperature of each hamburger is not reasonable for you to do, then you need to routinely verify that the speciﬁc process and cooking equipment are capable of attaining a ﬁnal internal product temperature at all locations in or on the cooking equipment. Once a speciﬁc process has been shown to work for you, the frequency of recordkeeping may be reduced. In these instances, a recordkeeping system should be established to provide scheduled product temperature checks to ensure that the process is working. Special consideration should be given to time and temperature in the cooking of ﬁsh and other raw animal foods. To control the pathogens, it is recommended that cooking be a CCP, based upon the critical limits established by the Food Code, unless you can show through scientiﬁc data that the food safety hazard will not result. e. Cooling. This operational step is only used for those foods that you have listed in Process 3. One of the most labor intensive operational steps is rapidly cooling hot foods to control microbial growth. Excessive time for the cooling of potentially hazardous foods has been consistently identiﬁed as one of the factors contributing to foodborne illness. Foods that have been cooked and held at improper temperatures provide an excellent environment for the growth of disease causing microorganisms that may have survived © 2003 by Marcel Dekker, Inc.

Table 4 Process

Cooking Worksheet Menu item

Hazard

Process 1

Example: salads, sushi

Does not apply

Process 2

Examples: hamburgers, mahi-mahi

Process 3

Example: soups

Bacterial, parasitic, or viral survival or growth Bacterial, parasitic, or viral survival or growth

© 2003 by Marcel Dekker, Inc.

CCP Does not apply Yes or no

Yes or no

Critical limits Does not apply Cook to product internal temperature/time (see Table 5) Cook to product internal temperature/time (see Table 5)

Monitoring

Corrective actions

Veriﬁcation

Records

Does not apply

Does not apply

Does not apply

Does not apply

Table 5

Food Code Cooking Temperatures and Times

Product 1a Poultry Wild game animals Stuffed ﬁsh Stuffed meat Stuffed pasta Stuffed poultry Stuffed ratites Stufﬁng containing ﬁsh, meat, poultry, or ratites 1b Animal foods cooked in a microwave oven 2a Pork, ratites, or injected meats 2b Ground meat, ﬁsh, or game animals commercially raised for food 2c Game animals under a voluntary inspection program 2d Raw shell eggs that are not prepared for immediate service 3a Raw shell eggs broken and prepared in response to consumer order and for immediate service 3b Fish and meat including game animals except as speciﬁcally referenced in this table 4a Fruit and vegetables cooked for hot holding 4b Ready-to-eat food from a commercially sealed container for hot holding 4c Ready-to-eat food from an intact package (from a food processing plant inspected by the regulatory authority with jurisdiction over the plant) for hot holding 5a Beef roast/corned beef roasts

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Final internal temperature

Time

165°F

15 sec.

165°F; food rotated, stirred, covered 155°F 155°F

Cover and allow to stand for 2 min. 15 sec. 15 sec.

155°F

15 sec.

155°F

15 sec.

145°F

15 sec.

145°F

15 sec.

140°F or above

Instantaneous

140°F or above

Instantaneous

140°F or above

Instantaneous

(Preheated oven temperatures) Less than 10 lb Still dry: 350°F or more Convection: 325°F or more High humidity: 250°F or less More than 10 lb Still dry: 250°F or more Convection: 250°F or more High humidity: 250°F or less

Table 5 Continued Product

Final internal temperature

5b Beef roast/corned beef roasts

Time

(Internal food temperature for speciﬁed amount of time) Achieve one of the following: 130°F for 121 min 132°F for 77 min 134°F for 47 min 136°F for 32 min 138°F for 19 min 140°F for 12 min 142°F for 8 min 144°F for 5 min 145°F for 3 min

the cooking process (spore formers). Recontamination of a cooked food item by poor employee practices of cross-contamination from other food products, utensils, and equipment is a concern at this operational step. (See Table 6). Special consideration should be given to large food items, such as roasts, turkeys, thick soups, stews, chili, and large containers of rice or refried beans. These foods take a long time to cool because of their mass and volume. If the hot food container is tightly covered, the cooling rate will be further slowed down. By reducing the volume of the food in an individual container and leaving an opening for heat to escape by keeping the cover loose, the rate of cooling is dramatically increased. Commercial refrigeration equipment is designed to hold cold food temperatures, not cool large masses of food. Some alternatives for cooling foods include 1.

2. 3. 4.

Using rapid chill refrigeration equipment designed to cool the food to acceptable temperatures quickly by using increased compressor capacity and high rates of air circulation Avoiding the need to cool large masses by preparing smaller batches closer to periods of service Stirring hot food while the food container is within an ice water bath Redesigning your recipe so that you prepare and cook a smaller or concentrated base and then add enough cold water or ice to make up the volume that you need (for water-based soups, for example)

Whatever cooling method you choose, you need to verify that the process works. Once again if a speciﬁc process has been shown to work for you, the frequency of recordkeeping may be reduced. A recordkeeping system should be established to provide scheduled product temperature checks to ensure the process is working. f. Reheating This operational step applies only to those foods that you listed in Process 3. If food is held at improper temperatures for enough time, pathogens have the opportunity to multiply to dangerous numbers. Proper reheating provides an important control for eliminating these organisms. It is especially effective in reducing contamination from bacterial spore formers which survived the cooking process and may have multiplied because foods were held at improper temperatures. (See Table 7.) © 2003 by Marcel Dekker, Inc.

Table 6 Process a

Cooling Worksheet Menu item

Hazard

Process 1

Examples: salads, sushi

Does not apply

Process 2

Examples: hamburgers, mahi-mahi Example: soups

Does not apply

Process 3

a

Bacterial growth, crosscontamination, contamination from employees or equipment

CCP Does not apply Does not apply Yes or no

Critical limits Does not apply Does not apply Cool food from 140°F to 70°F within 2 hr and from 70°F to 41°F within 4 hr Separate raw from ready-to-eat food Restrict ill employees; Control bare-hand contact

Process 1: food preparation with no cook step—ready-to-eat food that is stored, prepared and served. Process 2: food preparation for same-day service—food that is stored, prepared, cooked, and served. Process 3: complex food preparation—food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

© 2003 by Marcel Dekker, Inc.

Monitoring

Corrective actions

Veriﬁcation

Records

Does not apply Does not apply

Does not apply Does not apply

Does not apply Does not apply

Does not apply Does not apply

Table 7

Reheating Worksheet

Process a

Menu item

Process 1

Examples: salads, sushi

Does not apply

Process 2

Examples: hamburgers, mahi-mahi Example: soups

Does not apply

Process 3

a

Hazard

Bacterial, parasitic, or viral survival or growth

CCP Does not apply Does not apply Yes or no

Critical limits Does not apply Does not apply Reheat to 165°F within 2 hr.

Process 1: food preparation with no cook step—ready-to-eat food that is stored, prepared, and served. Process 2: food preparation for same-day service—food that is stored, prepared, cooked, and served. Process 3: complex food preparation—food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

© 2003 by Marcel Dekker, Inc.

Monitoring

Corrective actions

Veriﬁcation

Records

Does not apply Does not apply

Does not apply Does not apply

Does not apply Does not apply

Does not apply Does not apply

Although proper reheating will kill most organisms of concern, it will not eliminate toxins, such as that produced by Staphylococcus aureus. If microbial controls and SOPs at previous operational steps have not been followed correctly and staph toxin has been formed in the food, reheating will not make the food safe. Incorporating a comprehensive personal hygiene program throughout the process will minimize the risk from staph toxin. Along with personal hygiene, preventing crosscontamination through the use of cleaned and sanitized equipment and utensils is an important control measure. Special consideration should be given to the time and temperature in the reheating of cooked foods. To control the pathogens, it is recommended that reheating be a CCP, based upon the critical limits established by the Food Code, unless you can show through scientiﬁc data that the food safety hazard will not result. g. Holding. All three processes may involve holding. Proper temperature of the food while being held is essential in controlling the growth of harmful bacteria. Cold temperature holding may occur in Processes 1, 2, or 3. Hot temperature holding occurs primarily only in Processes 2 and 3. Where there is a cooking step as a CCP to elminate pathogens, all but the spore-forming organisms should be killed or inactivated. If cooked food is not held at the proper temperature, the rapid growth of these spore-forming bacteria is a major food safety concern. (See Table 8.) When food is held, cooled, and reheated in a food establishment there is an increased risk from contamination caused by personnel, equipment, procedures, or other factors. Harmful bacteria that are introduced into a product that is not held at proper temperature have the opportunity to multiply to large numbers in a short period of time. Once again management of personal hygiene and the prevention of cross-contamination impact the safety of the food at this operational step. Keeping food products at 140°F (60°C) or above during hot holding and keeping food products at or below 41°F (5°C) is effective in preventing microbial growth. As an alternative to temperature control, the Food Code details actions when time alone is used as a control, including a comprehensive monitoring and food marking system to ensure food safety. How often you monitor the temperature of foods during hot holding determines what type of corrective action you are able to take when 140°F (60°C) is not met. If the critical limit is not met, your options for corrective action may include evaluating the time the food is out of temperature to determine the severity of the hazard and based on that information, reheating the food, if appropriate, or discarding it. Monitoring frequency may mean the difference between reheating the food to 165°F (74°C) or discarding it. When determining the monitoring frequency of cold product temperatures, it is important to make sure that the interval between temperature checks is established to ensure that the hazard is being controlled and time is allowed for an appropriate corrective action. For example, if you are holding potentially hazardous ready-to-eat foods under refrigeration, such as potato salad at a salad bar, you may decide to set a critical limit at 41°F (5°C) or below. You may also want to set a target, or operating limit, of 40°F (4.4°C), for example, in order to provide a safety cushion that allows you the opportunity to see a trend toward exceeding 41°F (5°C) and to intervene with appropriate corrective actions. Special consideration should be given to the time and temperature in the hot or cold holding of potentially hazardous foods to control pathogens. It is recommended that hot © 2003 by Marcel Dekker, Inc.

Table 8

Holding Worksheet

Process a

Menu item

Hazard

CCP

Process 1

Examples: salads, sushi

Yes or no

41°F

Process 2

Examples: hamburgers, mahi-mahi

Yes or no

140°F or 41°F

Process 3

Example: soups

Bacterial, parasitic, or viral introduction, survival, or growth Bacterial, parasitic, or viral introduction, survival, or growth Bacterial, parasitic, or viral introduction, survival, or growth

Yes or no

140°F or 41°F

a

Critical limits

Monitoring

Process 1: food preparation with no cook step—ready-to-eat food that is stored, prepared, and served. Process 2: food preparation for same-day service—food that is stored, prepared, cooked, and served. Process 3: complex food preparation—food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

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Corrective actions

Veriﬁcation

Records

or cold holding be a CCP, based upon the critical limits established by the Food Code, unless you can show through scientiﬁc data that the food safety hazard will not result. h. Set-Up and Packing. Set-up and packing is an operational step used by some retail food establishments including caterers (e.g., restaurant/caterer or interstate conveyance caterer), commissaries, grocery stores (for display cases), schools, nursing homes, hospitals, or services such as delivery of meals to home-bound persons. Set-up and packing can be controlled through an SOP and may involve wrapping food items, assembling these items onto trays, and packing them into a transportation carrier or placing them in a display case. An example would be an airline ﬂight kitchen where food entrees are wrapped, assembled, and placed into portable food carts which are taken to a ﬁnal holding cooler. Hospital kitchens would be another example, where patient trays are assembled and placed into carriers for transportation to nursing stations. Food may be placed into bulk containers for transportation to another site where it is served. (See Table 9.) This operational step might not be considered a CCP, but it is a special consideration when setting up your program. This process can be controlled by strict adherence to SOPs to minimize the potential for bacterial contamination and growth, to eliminate bare-hand contact with ready-to-eat foods, to ensure proper hand washing, and to ensure food comes into contact only with cleaned and sanitized surfaces. Following ﬁnal assembly into either individual trays or into bulk containers, the food may be held for immediate service or for transportation to another site for service. This hot holding or cold holding operational step needs to be evaluated in the same manner as other holding operational steps on the worksheet. Temperature control or using time as a control measure during transportation and holding and serving at a remote site must be evaluated and managed as part of your food safety system. Special consideration should be given to time/temperature controls and the prevention of cross-contamination from equipment and utensils and contamination from employees’ hands. This process may be adequately controlled through an SOP; however, holding and transportation should be considered CCPs. i. Serving. This is the ﬁnal operational step before the food reaches the customer. When employees work with food and food-contact surfaces, they can easily spread bacteria, parasites, and viruses and contamintate these items. Managing employees’ personal hygienic practices is important to controlling these hazards. A management program for employee personal hygiene includes proper hand washing, the appropriate use of gloves and dispensing utensils, and controlling bare hand contact with ready-to-eat foods. (See Table 10.) Minimizing the growth of bacteria is also a concern at hot and cold holding customer display areas. Maintaining food products at proper temperature within these display units will control the growth of microorganisms. Refer to the holding worksheet for additional information. Special consideration needs to be given to minimizing contamination from the customer. Customer self-service displays, such as salad bars, require speciﬁc procedures to protect the food from contamination. Some suggestions for protecting food on display include 1. The use of packaging 2. Counter, service line, or salad bar food guards 3. Display cases © 2003 by Marcel Dekker, Inc.

Table 9 Process

Set-Up and Packing Worksheet Menu item

Process 1

Examples: salads, sushi

Process 2

Examples: hamburgers, mahi-mahi

Process 3

Example: soups

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Hazard

CCP

Critical limits

Bacterial growth, microbial contamination from employees Bacterial growth, microbial contamination from employees Bacterial growth, microbial contamination from employees

Yes or no

41°F No bare-hand contact or equivalent alternative 140°F or 41°F No bare-hand contact or equivalent alternative 140°F or 41°F No bare-hand contact or equivalent alternative

Yes or no

Yes or no

Monitoring

Corrective actions

Veriﬁcation

Records

Table 10 Process

Serving Worksheet Menu item

Process 1

Example: salads, sushi

Process 2

Examples: hamburgers, mahi-mahi

Process 3

Example: soups

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Hazard

CCP

Bacterial, parasitic, viral, or physical contamination Bacterial, parasitic, viral, or physical contamination Bacterial, parasitic, viral, or physical contamination

Yes or no

Yes or no

Yes or no

Critical limits

Monitoring

Corrective actions

Veriﬁcation

Records

4. 5. 6.

Suitable utensils or effective dispensing methods Not mixing an old product with fresh Having employees monitor self-serve stations

Preventing cross-contamination from soiled utensils and equipment will minimize the potential for bacterial contamination of ready-to-eat foods. C.

Step 3: Identify CCPs and Critical Limits

The CCPs column identiﬁes places in the ﬂow of food where you can have a signiﬁcant impact in controlling food safety hazards. A measurable critical limit has been identiﬁed for each of these CCPs. These critical limits provide the baseline for measuring the effectiveness of your food safety procedures. For each of your operational steps within your operation, review the CCPs and critical limits needed to minimize or eliminate signiﬁcant food safety hazards. Does your operation currently have control measures in place that are at least equivalent to these critical limits? On the worksheet, you will need to decide whether the operational step is a CCP or whether the hazard is controlled by the SOPs that address the prerequisite program elements discussed in the Food Code. In some operational step worksheets, such as for the cooking step, it is recommended that the step be considered a CCP because there is no practical alternative to ensure control of the hazard. In other operational steps, you may have a choice as to how you will control the hazard. For example, in the preparation step for ready-to-eat foods, you will identify contamination from employees’ hands as a hazard. When controlling that hazard as a CCP, you must also identify the critical limits, establish monitoring and corrective actions, veriﬁcation procedures, and records. Alternatively, you may choose to control that hazard by instituting an SOP that disallows bare hand contact with ready-to-eat foods, you will identify contamination from employees’ hands as a hazard. When controlling that hazard as a CCP, you must also identify the critical limits, establish monitoring and corrective actions, veriﬁcation procedures, and records. Alternatively, you may choose to control that hazard by instituting an SOP that disallows bare-hand contact wtih ready-to-eat food. You will need to decide the most effective method of controlling the hazard, i.e., as a CCP or through use of an SOP. D.

Step 4: Monitor Critical Control Points

Use the worksheet to develop procedures, customized to your operation, for monitoring your CCPs. Consideration should be given to determining answers to the following questions: 1. 2. 3. 4.

What critical limit at the CCP are you measuring? How is it monitored? When and how often will the CCP be monitored? Who will be responsible for monitoring it?

Monitoring is observing or measuring speciﬁc operational steps in the food process to determine if your critical limits are being met. This activity is essential in making sure your critical food processes are under control. It will identify where a loss of control © 2003 by Marcel Dekker, Inc.

occurs or if there is a trend toward a loss of control of a critical food process. Needed adjustments will then become obvious. In your food safety management system, certain processes have been identiﬁed as CCPs. What you are going to monitor depends on the critical limits you have established at each CCP. Minimum critical limits for many CCPs have been established by the Food Code. For example, cooking hamburger (the CCP) to 155°F (68.3°C) for 15 sec (the critical limit) will kill most harmful bacteria. Therefore, ﬁnal temperature and time measurements are very important. You need to determine how you will effectively monitor the critical limits for each CCP. Is monitoring equipment needed to measure a critical limit? The equipment you choose for monitoring must be accurate and routinely calibrated to ensure critical limits are met. For example, a thermocouple with a thin probe might be the most appropriate tool for measuring the ﬁnal product temperature of hamburger patties. When describing how often you need to monitor, make sure that the monitoring interval will be reliable enough to ensure the hazard is being controlled. Your procedure for monitoring should be simple and easy to follow. Individuals chosen to be responsible for a monitoring activity may be a manager, line supervisor, or a designated employee. Your monitoring system will only be effective if employees are given the knowledge, skills, and reponsibility for serving safe food. Train your employees to carefully follow your procedures, monitor CCPs, and take corrective action if critical limits are not met. E.

Step 5: Develop Corrective Actions

Decide what type of corrective action you need to take if a critical limit is not met. 1. 2. 3. 4.

What measures do you expect employees to take to correct the problem? Is the corrective action understood by your employees? Can the corrective action be easily implemented? Are different options needed for the appropriate corrective actions, depending on the process and monitoring frequency? 5. How will these corrective actions be documented and communicated to management so the system can be modiﬁed to prevent the problem from occurring again? Whenever a critical limit is not met, a corrective action must be carried out immediately. Corrective actions may be simply continuing to heat food to the required temperature. Other corrective actions may be more complicated, such as rejecting a shipment of raw oysters that does not have the required tags or segregating and holding a product until an evaluation is done. In the event that a corrective action is taken, you should reassess and modify, if necessary, your food safety system based upon the HACCP principles. Despite the best system, errors occur during food storage and preparation. A food safety system based upon the HACCP principles is designed to detect errors and correct them before a food hazard occurs. It is a beneﬁt to industry and regulators to be able to show that immediate action is taken to ensure that no food product that may be injurious to health is served to or purchased by a customer. It is important to document all corrective actions in written records. © 2003 by Marcel Dekker, Inc.

F.

Step 6: Conduct Ongoing Veriﬁcation

1. Description Because HACCP is a system to maintain continuous control of food safety practices, implementation of the plan needs to be audited or veriﬁed. Veriﬁcation is usually performed by someone other than the person who is responsible for performing the activities speciﬁed in the plan. That person might be a manager, supervisor, designated person, or the regulatory authority. There is ongoing veriﬁcation, which is conducted frequently, such as daily, weekly, monthly, etc., by designated employees of the establishment. It is important to note that routine monitoring should not be confused with audit or veriﬁcation methods or procedures. There is long-term veriﬁcation, which is done less frequently. This will be discussed in Section IV.H. Veriﬁcation is an oversight auditing process to ensure that the HACCP plan and SOPs continue to 1. 2.

Be adequate to control the hazards is identiﬁed as likely to occur Be consistently followed (i.e., a comparison is made regarding observed, actual practices and procedures with what is written in the plan)

Ongoing veriﬁcation activities include 1. 2.

Observing the person doing the monitoring; is monitoring being done as planned? Reviewing the monitoring records: a. Are records completed accurately? b. Do records show that the predetermined frequency of the monitoring is followed? c. Was the planned corrective action taken when the person monitoring found and recorded that the critical limit was not met? d. Do records of the calibration of monitoring equipment indicate that the equipment was operating properly?

2. Procedures Procedures may include the following activities: 1. 2. 3. 4. 5. 6. 7.

Observe the person conducting the activities at the CCPs and recording information. Check monitoring records. Check corrective action records. Periodically review the total plan. Test product in process or ﬁnished product. Review equipment calibration records. Review recording thermometer accuracy (large operations and some processes such as large quantity cook and chill operations or smokers, etc.)

3. Frequency Veriﬁcation should occur at a frequency that can ensure the HACCP plan is being followed continuously to © 2003 by Marcel Dekker, Inc.

1. 2. 3. 4.

Avoid adulterated/unsafe product getting to the consumer Be able to take corrective action without loss of product Ensure prescribed personnel practices are consistently followed Ensure personnel have the tools for proper personal hygiene and sanitary practices (e.g., hand washing facilities, sanitizing equipment, cleaning supplies, temperature measuring devices, sufﬁcient gloves, etc.) 5. Follow/comply with the control procedures established 6. Conduct calibrations as needed depending upon the type of equipment (some may be veriﬁed daily and others annually) 4. System Veriﬁcation a. Receiving. The manager reviews temperature logs of refrigerated products at various intervals such as daily or weekly. An operation may want its HACCP plan to specify that the manager checks the monitoring records daily if (1) receiving constitutes a high volume or (2) products include particular items such as fresh tuna, mahi-mahi, mackerel, etc. (scombrotoxin-forming species). b. Chill Step. Weekly, the production manager checks the chilling log that is maintained for foods that are either left over or planned for later service. Recorded on the log sheet are the time the food is placed into the cooler, its temperature, the type of container used (depth per SOP), and measurements of the time and temperature involved in cooling the food. c. Hand Washing Facilities and Practices. Daily, the manager checks the log maintained at the hand washing facilities and corrections made in areas where ready-to-eat food is prepared. Less frequent checks are made in other areas of the operation. 5. Process Veriﬁcation The manager checks daily or weekly the time/temperature monitoring records at all CCPs (receiving, holding, preparation before cooking for scombrotoxin-forming seafood, cooking time/temperature for hamburgers, etc.). G.

Step 7: Keep Records

In order to develop the most effective recordkeeping system for your operation, determine what documented information will assist you in managing the control of food safety hazards. Some recorded information should already be part of your food safety system, like shellﬁsh tags, and an additional record may not be needed. Your recordkeeping system can use existing paperwork, such as delivery invoices, for documenting product temperature. Another method could be maintaining a log to record the temperatures. A recordkeeping system can be simple and needs to be designed to meet the needs of the individual establishment. It can be accomplished in many different ways that are customized to your operation as long as it provides a system to determine that activities are performed according to the HACCP plan. Accurate recordkeeping is an essential part of a successful HACCP program. Records provide documentation that the critical limits at each CCP were met or that appropriate corrective actions were taken when the limits were not met. Records also show that the actions performed were veriﬁed. © 2003 by Marcel Dekker, Inc.

Involve your employees in the development of your management system. Ask them how they are currently monitoring CCPs. Discuss with them the types of corrective actions they take when a critical limit is not met. Employees are an important source for developing simple and effective recordkeeping procedures. Managers are responsible for designing the system, but effective day-to-day implementation involves every employee. The simplest recordkeeping system that lends itself to integration into existing operations is always best. A simple yet effective system is easier to use and communicate to your employees. Recordkeeping systems designed to document a process rather than product information may be more adaptable within a retail food establishment, especially if you frequently change items on your menu. Accurately documenting processes like cooking, cooling, and reheating, identiﬁed as CCPs, provides active managerial control of food safety hazards. Consistent process control by management reduces the risk of foodborne illness. Simple logs for record refrigeration equipment temperature are perhaps the most common SOP records currently maintained. However, product temperature records are commonly CCP records. Other records may include 1. 2. 3.

Writing the product temperature on delivery invoices Keeping a log of internal product temperatures of cooked foods Holding shellstock tags for 90 days

Some retail establishments have implemented comprehensive HACCP systems where records are maintained for each CCP. These records may be quality control logs, but they can also constitute CCP records if they are designed to monitor activities that are, in fact, CCPs. The level of sophistication of recordkeeping is dependent upon the complexity of the food operation. For example, a cook–chill operation for a large institution would require more recordkeeping than a limited menu, cook–serve operation. Once a speciﬁc process has been shown to work for you, such as an ice bath method for cooling certain foods, the frequency of recordkeeping may be reduced. In these instances, a recordkeeping system provides a scheduled check (veriﬁcation) of the process to ensure that it effectively controls the risk factors. This approach is extremely effective for labor-intensive processes related to 1. 2. 3. 4.

H.

Cooking large volumes of food where a temperature check of each individual item is impractical Implementing a veriﬁed process that will allow employees to complete the procedure within the course of a scheduled work day Cooling foods or leftovers at the end of the business day Maintaining cold holding temperatures of ready-to-eat potentially hazardous foods in walk-in refrigeration units

Step 8: Conduct Long-Term Veriﬁcation

Once your food safety system is implemented, you will need to conﬁrm that it is effective over time, an activity referred to in this chapter as long-term veriﬁcation. You may beneﬁt from both internal (quality control) veriﬁcations and external veriﬁcations that may involve assistance from the regulatory authority or consultants. See Table 11 for a sample long-term veriﬁcation worksheet. Long-term veriﬁcation is conducted less frequently (e.g., yearly) than ongoing veriﬁcation. It is a review or audit of the plan to determine if © 2003 by Marcel Dekker, Inc.

1. 2. 3. 4. 5. 6.

Any new product/processes/menu items have been added to the menu. Suppliers, customers, equipment, or facilities have changed. The SOPs are current and implemented. The worksheets are still current. The CCPs are still correct or if new CCPs are needed. The critical limits are set realistically and are adequate to control the hazard (e.g., the time needed to cook turkey to meet the Food Code internal temperature requirement). 7. Monitoring equipment has been calibrated as planned. Long-term veriﬁcation helps the operator 1. Ensure the food safety management system is implemented and the HACCP plan is being followed. 2. Improve the system and HACCP plan by identifying weaknesses. 3. Eliminate the unnecessary or ineffective controls. 4. Determine if the HACCP plan needs to be modiﬁed or updated.

Table 11

Long-Term Veriﬁcation Worksheet

Name of person responsible for long-term veriﬁcation: Title: Frequency at which the long-term veriﬁcation is done: Reason for doing an unscheduled long-term veriﬁcation:

Date of last long-term veriﬁcation: The length of time this record is kept on ﬁle: Question

Answer

Action

Date logged

Name logged

Date:

Name:

1. a. Has a new product, process, or menu item been added since the last veriﬁcation and does this change necessitate a change on the worksheet? b. Has the supplier, customer, equipment, or facility changed since the last veriﬁcation? 2. Do the existing worksheets contain accurate and current information?

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No

No action

Yes

Go to Question 2

Yes

No action

No

Go to Question 2

No

Worksheet information updated: Go to Quesion 4

Yes

Table 11 Continued Question

Answer

3. Are the existing CCPs correctly identiﬁed?

No

4. Are the existing critical limits appropriate to control each hazard? 5. Do the existing monitoring procedures ensure that the critical limits are met? 6. Do the existing corrective actions ensure that no injurious food is served or purchased? 7. Do the existing ongoing veriﬁcation procedures ensure that the food safety system is adequate to control hazards and is consistently followed? 8. Does the existing recordkeeping system provide adequate documentation that the critical limits are met and corrective actions are taken when needed? 9. Are the existing SOPs current and implemented?

Date logged

Name logged

CCP updated:

Date:

Name:

Yes No

Go to Question 4 CLs updated:

Date:

Name:

Yes No

Go to Question 5 Monitoring procedures updated: Go to Question 6

Date:

Name:

Corrective actions updated: Go to Question 7

Date:

Name:

Ongoing veriﬁcation procedures update: Go to Question 8

Date:

Name:

Recordkeeping procedures updated: Go to Question 9

Date:

Name:

Yes No Yes No Yes

No Yes

No Yes

Action

Does this necessitate a change in your plan? If so, start again with Question 1.

The long-term veriﬁcation procedure is now complete. The next long-term veriﬁcation is due . The changes made to the food safety management system were conveyed to the line supervisor or front-line employees on . Completed by: Name: Title: Date:

REFERENCE 1. Food Code. 2001. Washington, DC: Food and Drug Administration, 2001.

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34 Retail Food Processing: Reduced Oxygen Packaging, Smoking, and Curing Y. H. HUI Science Technology System, West Sacramento, California, U.S.A.

I.

BACKGROUND INFORMATION

The Food Code of 2001 (and also several earlier editions) includes an annex section on the responsibilities of the retail food industry in the production and sale of foods that are packaged with reduced oxygen, smoked, or cured. This chapter is a modiﬁed version of the original document [1], Nevertheless, the reader should directly consult the current edition of the Food Code for ofﬁcial guidance on any particular. From its inception, the retail segment of the food industry has prepared foods in consumer-sized portions, using commercially available equipment for cutting, grinding, slicing, cooking, and refrigeration and applying herbs and spices readily available to consumers at their local grocery. Over the past scores of years, some retail segment operators have expanded into food manufacturing/processing-type operations, often using sophisticated new technologies and equipment that are sometimes microprocessor controlled. Many now desire to alter the atmospheres within food packages or apply federally regulated chemical food additives as a method of food preservation. Food processing operations now being conducted or proposed include cook–chill; vacuum packaging; sous vide; smoking and curing; brewing, processing, and bottling alcoholic beverages, carbonated beverages, or drinking water; and custom processing of animals. The Food Code speciﬁes that a HACCP plan acceptable to the regulatory authority be the basis for approving food manufacturing/processing operations at retail. The HACCP plans are to be provided and accepted in two ways as follows. © 2003 by Marcel Dekker, Inc.

1.

2.

Reduced oxygen packaging. The Food Code provides the criteria that are to be met in the HACCP plans of those operators who are conducting reduced oxygen packaging (ROP) operations. Unless prior approval of the HACCP plan is required by the regulatory authority, the HACCP plan covering this operation along with the related records documenting monitoring and corrective actions need only be available and acceptable to the regulatory authority at the time of inspection. Other food manufacturing/processing operations. The Food Code speciﬁes that the food establishment operator must obtain a variance from the regulatory authority for all food manufacturing/processing operations based on the prior approval of a HACCP plan.

This chapter is designed to provide current preliminary processing criteria for different types of food manufacturing/processing operations for use by those preparing and reviewing HACCP plans and proposals. Criteria for additional processes will be provided in future editions of the Food Code as they are developed, reviewed, and accepted by regulatory authorities.

II. REDUCED OXYGEN PACKAGING A.

Introduction

Because ROP provides an environment that contains little or no oxygen, it offers unique advantages and opportunities for the food industry but also raises many microbiological concerns. Products packaged using ROP may be produced safely if proper controls are in effect. Producing and distributing these products with a HACCP approach offers an effective, rational, and systematic method for the assurance of food safety. This section provides guidelines for effective food safety controls for retail food establishments covering the receipt, processing, packaging, holding, displaying, and labeling of food in reduced oxygen packages. B.

Deﬁnitions

The term ROP is deﬁned as any packaging procedure that results in a reduced oxygen level in a sealed package. The term is often used because it is an inclusive term and can include other packaging options such as: 1. 2.

3.

Cook–chill. A process that uses a plastic bag ﬁlled with hot cooked food from which air has been expelled and which is closed with a plastic or metal crimp. Controlled atmosphere packaging (CAP). An active system that continuously maintains the desired atmosphere within a package throughout the shelf-life of a product by the use of agents to bind or scavenge oxygen or a sachet containing compounds to emit a gas. Controlled atmosphere packaging is deﬁned as packaging of a product in a modiﬁed atmosphere followed by maintaining subsequent control of that atmosphere. Modiﬁed atmosphere packaging (MAP). A process that employs a gas ﬂushing and sealing process or reduction of oxygen through respiration of vegetables or microbial action. Modiﬁed atmosphere packaging is deﬁned as packaging of a product in an atmosphere that has had a one-time modiﬁcation of gaseous

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composition so that it is different from that of air, which normally contains 78.08% nitrogen, 20.96% oxygen, and 0.03% carbon dioxide. 4. Sous vide. A specialized process of ROP for partially cooked ingredients alone or combined with raw foods that require refrigeration or frozen storage until the package is thoroughly heated immediately before service. The sous vide process is a pasteurization step that reduces bacterial load but is not sufﬁcient to make the food shelf stable. The proces involves the following steps. a. Preparations of the raw materials (this step may include partial cooking of some or all ingradients) b. Packaging of the product, application of vacuum, and sealing of the package c. Pasteurization of the product for a speciﬁed and monitored time/temperature d. Rapid and monitored cooling of the product at or below 3°C (37.4°F) or frozen e. Reheating of the packages to a speciﬁed temperature before opening and service 5. Vacuum packaging. A process that reduces the amount of air from a package and hermetically seals the package so that a near-perfect vacuum remains inside. A common variation of this process is vacuum skin packaging (VSP). A highly ﬂexible plastic barrier is used by this technology that allows the package to mold itself to the contours of the food being packaged. C. Beneﬁts of ROP Reduced oxygen packaging can create a signiﬁcantly anaerobic environment that prevents the growth of aerobic spoilage organisms, which generally are gram-negative bacteria such as pseudomonads or aerobic yeast and molds. These organisms are responsible for off-odors, slime, and texture changes—all signs of spoilage. Reduced oxygen packaging can be used to prevent degradation or oxidative processes in food products. Reducing the oxygen in and around a food retards the amount of oxidative rancidity in fats and oils. It also prevents color deterioration in raw meats caused by oxygen. An additional effect of sealing food in ROP is the reduction of product shrinkage by preventing water loss. These beneﬁts of ROP allow an extended shelf-life for foods in the distribution chain, providing additional time to reach new geographic markets or longer display at retail. Providing an extended shelf-life for ready-to-eat convenience foods and advertising foods as ‘‘Fresh—Never Frozen’’ are examples of economic and quality advantages. D. Safety Concerns Use of ROP with some foods can markedly increase safety concerns. Unless potentially hazardous foods are protected inherently, simply placing them in ROP without regard to microbial growth will increase the risk of foodborne illnesses. Processors and regulators of ROP must assume that during distribution of foods or while foods are held by retailers or consumers, refrigerated temperatures may not be consistently maintained. In fact, a serious concern is that the increased use of vacuum packaging at retail supermarket delitype operations may be followed by temperature abuse in the establishment or by the consumer. Consequently, at least one barrier or multiple hurdles resulting in a barrier need © 2003 by Marcel Dekker, Inc.

to be incorporated into the production process for products packaged using ROP. The incorporation of several subinhibitory barriers, none of which could individually inhibit microbial growth but which in combination provide a full barrier to growth, is necessary to ensure food safety. Some products in ROP contain no preservatives and frequently do not possess any intrinsic inhibitory barriers (such as pH, aw , or salt concentrations) that either alone or in combination will inhibit microbial growth. Thus, product safety is not provided by natural or formulated characteristics. An anaerobic environment, usually created by ROP, provides the potential for growth of several important pathogens. Some of these are psychotrophic and grow slowly in temperatures near the freezing point of foods. Additionally, the inhibition of the spoilage bacteria is signiﬁcant because without these competing organisms telltale signs that the product is no longer ﬁt for consumption will not occur. The use of one form of ROP, vacuum packaging, is not new. Many food products have a long and safe history of being vacuum packaged in ROP. However, the early use of vacuum packaging for smoked ﬁsh had disastrous results, causing a long-standing moratorium on certain uses of this technology. E.

Refrigerated Holding Requirements for Foods in ROP

Safe use of ROP technology demands that adequate refrigeration be maintained during the entire shelf-life of potentially hazardous foods to ensure product safety. Bacteria, with the exception of those that can form spores, are eliminated by pasteurization. However, pathogens may survive in the ﬁnal product if pasteurization is inadequate, poor quality raw materials or poor handling practices are used, or postprocessing contamination occurs. Even if foods that are in ROP receive adequate thermal processing, a particular concern is present a retail when employees open manufactured products and repackage them. This operation presents the potential for postprocessing contamination by pathogens. If products in ROP are subjected to mild temperature abuse, i.e., 5–12°C (41– 53.6°F), at any stage during storage or distribution, foodborne pathogens, including Bacillus cereus, Salmonella spp., Staphylococcus aureus, and Vibrio parahaemolyticus, can grow slowly. Marginal refrigeration that does not facilitate growth may still allow Salmonella spp., Campylobacter spp., and Brucella spp. to survive for long periods of time. Published surveys indicate that refrigeration practices at retail need improvement. Some refrigerated products offered in convenience stores were found at or above 7.22°C (45°F) 50% of the time; in several cases temperature as high as 10°C (50°F) were observed. Delicatessen display cases have been shown to demonstrate poor temperature control. Foods have been observed above 10°C (50°F) and above 12.77°C (55°F) in several instances. Supermarket fresh meat cases appear to have a relatively good record of temperature control. However, even these foods can occasionally be found above 10°C (50°F). Temperature abuse is common throughout distribution and retail markets. Strict adherence to temperature control and shelf-life must be observed and documented by the etablishment using ROP. Information on temperature control should also be provided by the consumer. Currently these controls are not extensively used. Additionally, some commercial equipment is incapable of maintaining foods below 7.22°C (45°F) because of inadequate refrigeration capacity, insufﬁcient refrigerating medium, or poor maintenance. © 2003 by Marcel Dekker, Inc.

Most warehouses and transport vehicles in U.S. distributions chains maintain temperatures in the 0–3.33°C (32–38°F) range. It must be assumed, however, for purposes of assessing risk that occasionally temperatures of 10°C (50°F) or higher may occur for extended periods. At retail, further temperature abuse must also be assumed. For instance, retail display cases can be as high as 13.33°C (56°F) for short periods and some refrigerated foods are provided no refrigeration for short periods of time. These realities point to the need for establishments to implement controls, such as buyer speciﬁcations over refrigerated distribution systems so that better temperature control can be ensured. F.

Control of Clostridium botulinum and Listeria monocytogenes in ROP Foods

Recently, there has been an increased interest in vacuum packaging or MAP at retail using conventional refrigeration for holding. Refrigerated foods packaged at retail may be chilled either after they are physically prepared and repackaged or packaged after a cooking step. In either case, but primarily the latter, germination of Clostridium botulinum spores must be inhibited because spores are not destroyed by a heating step. Sanitary safeguards must be employed to prevent reintroduction of pathogens. Chief among these is Listeria monocytogenes. Clostridium botulinum is the causative agent of botulism, a severe food poisoning characterized by double vision, paralysis, and occasionally death. The organism is an anaerobic, spore-forming bacterium that produces a potent neurotoxin. The spores are ubiquitous in nature, relatively heat resistant, and can survive most minimal heat treatment that destroy vegetative cells. Certain strains of C. botulinum (type E and nonproteolytic types B and F), which have been primarily associated with ﬁsh, are psychrotrophic and can grow and produce toxin at temperature as low as 3.33°C (38°F). Other strains of C. botulinum (type A and proteolytic types B and F) can grow and produce toxin at temperatures slightly above 10°C (50°F). If present, C. botulinum could potentially grow and render toxigenic a food packaged and held in ROP because most other competing organisms are inhibited by ROP. Therefore, the food could be toxic yet appear organoleptically acceptable. This is particularly true of psychrotrophic strains of C. botulinum that do not produce telltale proteolytic enzymes. Because botulism is potentially deadly, foods held in anaerobic conditions merit regulatory concern and vigilance. The potential for botulism toxin to develop also exitst when ROP is used after heat treatments, such as pasteurization or sous vide processing of foods that do not destroy the spores of C. botulinum. Mild heat treatments in combination with ROP may actually select for C. botulinum by killing off its competitors. If the applied heat treatment does not produce commercial sterility, the food requires refrigeration to prevent spoilage and ensure product safety. For this reason, sous vide products are frequently ﬂash frozen in liquid nitrogen and held in frozen storage until use. There is a further microbial concern with ROP at retail. Processed products such as meats and cheeses that have undergone an adequate cooking step to kill L. monocytogenes can be contaminated when opened, sliced, and repackaged at retail. Thus, a simple packaging or repackaging operation can present an opportunity for recontamination with pathogens if strict sanitary safeguards are not in place. Processors of products using ROP should be cautious if they plan to rely on refrigeration as the sole barrier that ensures product safety. This approach requires very rigorous © 2003 by Marcel Dekker, Inc.

temperature controls and monitored refrigeration equipment. If extended shelf-life is sought, a temperature of 3.33°C (38°F) or lower must be maintained at all times to prevent outgrowth of C. botulinum and the subsequent production of toxin. Listeria monocytogenes can grow at even lower temperatures, consequently, appropriate use-by dates must be established and readily apparent to the consumer. Since refrigeration alone does not guarantee safety from pathogenic microorganisms, additional growth barriers must be provided. Growth barriers are provided by hurdles such as providing for low pH and aw , a short shelf-lfe, and constant monitoring of the temperature. Any one hurdle, or a combination of several, may be used with refrigeration to control pathogenic outgrowth. G.

Design of Heat Processes for Foods in ROP

Heat processes for sous vide or cook–chill operations should be designed so that, at a minimum, all vegetative pathogens are destroyed by a pasteurization process. Special labeling of these products is necessary to ensure adequate warning to consumers that these foods must be refrigerated at 5°C (41°F) and consumed by the date required by the regulatory guidance for that particular product. The National Advisory Committee on Microbiological Criteria for Foods (NACMCF), chartered by the U.S. Department of Agriculture (USDA) and the Department of Health and Human Services (DHHS), has provided guidance regarding the microbial safety of refrigerated foods containing cooked, uncured meat or poultry products that are packaged for extended refrigerated shelf-life and are ready-to-eat or prepared with little or no additional heat treatment. The committee recommended guidlines for evaluating the ability of thermal processes to inactivate L. monocytogenes in extended-shelf-life, refrigerated foods. Speciﬁcally, it recommended a proposed requirement for demonstrating that ROP processing should include a heat treatment sufﬁcient to achieve a 4 decimal log reduction (4D) of L. monocytogenes. Other scientiﬁc reports recommend more extensive thermal processing. Thermal processes for sous vide practiced in Europe are designed to achieve a 12–13 log reduction (12–13D) of the target organism, Streptococcus faecalis. It is reasoned that thermal inactivation of this organism would ensure destruction of all other vegetative pathogens. Food manufacturers with adequate in-house research and development programs may have the ability to design their own thermal processes. However, small retailers and supermarkets may not be able to perform the microbiological challenge studies necessary to provide the same level of food safety. If a retail establishment wishes to use an ROP process, microbiological studies should be performed by, or in conjunction with, an appropriate process authority or person knowledgeable in food microbiology who is acceptable to the regulatory authority. Finally, if foods are held long enough, even under proper refrigeration, extended shelf-life may be a problem. A study on fresh vegetables inoculated with L. monocytogenes conducted to determine the effect of CAP on shelf-life found that CAP lengthened the time that all vegetables were considered acceptable, but that populations of L. monocytogenes increased during that extended storage. H.

Consumer Handling Practices and In-Home Refrigerator Temperatures

Extended shelf-life provided by ROP is cause for concern because of the potential for abuse by the consumer. Consumers often cannot, or do not, maintain adequate refrigeration © 2003 by Marcel Dekker, Inc.

of potentially hazardous foods at home. Foods in ROP that are taken home might not be eaten before sufﬁcient time/temperature abuse has occurred to allow any pathogens present to increase to levels which can increase the chance of illness. Under the best of circumstances, home refrigerators can be expected to range between 5 and 10°C (41–50°F). One study reported that home refrigerator temperatures in 21% of the households surveyed were 10°C (50°F). Another study reported more than one of four home refrigerators are above 7.22°C (45°F) and almost one of ten are above 10°C (50°F). Thus, refrigeration alone cannot be relied on for ensuring microbiological safety after foods in ROP leave the establishment. Consumers have come to expect that certain packages of foods would be safe without refrigeration. Low-acid canned foods have been thermally processed, which renders the food shelf stable. Retort heating ensures the destruction of C. botulinum spores as well as all other foodborne pathogens. Yet consumers may not understand that most products that are packaged in ROP are not commercially sterile or shelf stable and must be refrigerated. A clear label statement to keep the product refrigerated must be provided to consumers. I.

Safety Barrier Veriﬁcation

The safety barriers for all processed foods held in ROP at retail must be veriﬁed in writing. This can be accomplished through written certiﬁcation from the product manufacturer. Independent laboratory analysis using methodology approved by the regulatory authority can also be used to verify incoming product and should be used to verify the barriers in a product that is packaged within the establishment by an ROP method. The multiple barrier or hurdle efﬁcacy should be validated by inoculated pack or challenge studies. A product should be tested under abuse temperatures to demonstrate product safety during the food shelf-life. Any changes in product formulation or processing procedures are cause for notiﬁcation of the regulatory authority and a required approval of the revised ROP process. A record of all safety barrier veriﬁcations should be updated every 12 months. This record must be available to the regulatory authority for review at the time of inspection. J. USDA Process Exemption Meat and poultry products cured at a food processing plant regulated by the U.S. Department of Agriculture using substances speciﬁed in 9 CFR 318.7 (approval of substances for use in the preparation of products) and 9 CFR 381.147 (restrictions on the use of substances in poultry products) are exempt from the safety barrier veriﬁcation requirements. Other ROP operations may be developed if prior approval is obtained from the regulatory authority. K. Recommendations for ROP Without Multiple Barriers 1. Employee training. If ROP is used, employees assigned to packaging of the foods must have documented proof that demonstrates familiarity with ROP guidelines in the Food Code and the potential hazards associated with these foods. At the discretion of the regulatory authority, a description of the training and course content provided to the employees must either be available for review or have prior approval by the regulatory authority. © 2003 by Marcel Dekker, Inc.

2.

3.

4.

5.

Refrigeration requirements. Foods in ROP that have only one barrier, i.e., refrigeration, to C. botulinum must be refrigerated to 5°C (41°F) or below and marked with a use-by date within either the manufacturer’s labeled use-by date or 14 days after preparation at retail, whichever comes ﬁrst. Alternatively, food packaged by ROP may be kept frozen if freezing is used as the declared primary safety barrier. Any extension of shelf-life past 14 days will require a further variance that considers lower refrigeration temperatures. Foods that are intended for refrigerated storage beyond 14 days must be maintained at or below 3.33°C (38°F). Labeling—refrigeration statements. All foods in ROP which rely on refrigeration as a barrier to microbial growth must bear the statement ‘‘Important—must be kept refrigerated at 5°C (41°F)’’ or ‘‘Important—must be kept frozen’’ in the case of foods which rely on freezing as a primary safety barrier. The statement must appear on the principal display panel in bold type on a contrasting background. Foods held under ROP that have lower refrigeration requirements as a condition of safe shelf-life must be monitored for temperature history and must be offered for retail sale if the temperature and time speciﬁed in the variance are exceeded. Labeling—use-by date. Each container of food in ROP must bear a use-by date. This date cannot exceed 14 days from retail packaging or repackaging without a further variance granted by the regulatory authority. The date assigned by a repacker cannot extend beyond the manufacturer’s recommended pull date for the food. The use-by date must be listed on the principal display panel in bold type on a contrasting background. Any label must contain a combination of a sell-by date and use-by instructions which makes it clear that the product must be consumed within 14 days of retail packaging or repackaging, as an acceptable alternative to a 14-day use-by date, e.g., for product packaged on November 1, 2001—‘‘Sell by November 10, 2001’’—use within 4 days of sellby date. Foods that are frozen before or immediately after packaging and remain frozen until use should bear a ‘‘Keep frozen, use within 4 days after thawing’’ statement. Foods which require a variance. a. Processed ﬁsh and smoked ﬁsh may not be packed by ROP unless establishments are approved for the activity and inspected by the regulatory authority. Establishments packaging such ﬁsh products, and smoking and packing establishments, must be licensed in acoordance with applicable law. Caviar may be packed on the premises by ROP if the establishment is approved by the regulatory authority and has an approved scheduled process established by a processing authority acceptable to the regulatory authority. b. Soft cheese such as ricotta, cottage cheese, cheese spreads, and combinations of cheese and other ingredients such as vegetables, meat, or ﬁsh at retail must be approved for ROP and inspected by the regulatory authority. c. Meat or poultry products which are smoked or cured at retail—except raw food of animal origin which is cured in a USDA-regulated processing plant or establishment approved by the regulatory authority to cure these foods— may be smoked in accordance with approved time/temperature requirements and packaged in ROP at retail if approved by the regulatory authority.

© 2003 by Marcel Dekker, Inc.

6. Hazard analysis and critical control point (HACCO) Operation. All food establishments packaging food in a reduced oxygen atmosphere must develop a HACCP plan and maintain the plan at the processing site for review by the regulatory authority. For ROP operations the plan must include a. A complete description of the processing packaging, and storage procedures designated as critical control points, with attendant critical limits, corrective action plans, monitoring and veriﬁcation schemes, and records required b. A list of equipment and food-contact packaging supplies used, including compliance standards required by the regulatory authority, i.e., USDA or a recognized third party equipment by the evaluation organization such as NSF International c. A description of the lot identiﬁcation system acceptable to the regulatory authority d. A description of the employee training program acceptable to the regulatory authority e. A listing and proportion of food-grade gasses used f. A standard operating procedure for method and frequency of cleaning and sanitizing food-contact surfaces in the designated processing area 7. Precaution against contamination at retail. Only unopened packages of food products obtained from sources that comply with the applicable laws relating to food safety can be used to package at retail in a reduced oxygen atmosphere. If it is necessary to stop packaging for a period in excess of one-half hour, the remainder of that product must be diverted for another use in the retail establishment. 8. Disposition of expired product at retail. Processed reduced oxygen foods that exceed the use-by date or manufacturer’s pull date cannot be sold in any form and must be disposed of in a proper manner. 9. Dedicated area/restricted access. All aspects of reduced oxygen packaging shall be conducted in an area speciﬁcally designated for this purpose. There shall be an effective separation to prevent cross-contamination between raw and cooked foods. Access to processing equipment shall be restricted to responsible, trained personnel who are familiar with the potential hazards inherent in food packaged by an ROP method. Some ROP procedures such as sous vide may require a sanitary zone or dedicated room with restricted access to prevent contamination. III. SMOKING AND CURING A. Introduction Meat and poultry are cured by the addition of salt alone or in combination with one or more ingredients such as sodium nitrite, sugar, curing accelerators, and spices. These are used for partial preservation, ﬂavoring, color enhancement, tenderizing, and improving yield of meat. The process may include dry curing, immersion curing, direct addition, or injection of the curing ingredients. Curing mixtures are typically composed of salt (sodium chloride), sodium nitrite, and seasoning. the preparation of curing mixtures must be carefully controlled. Several proprietary mixtures of uniform composition are available. The © 2003 by Marcel Dekker, Inc.

maximum residual sodium nitrite in the ﬁnished product is limited to 200 ppm by the USDA. A sodium nitrite concentration of 120 ppm is usually sufﬁcient for most purposes. Speciﬁc requirements for added nitrite may be found in USDA regulations 9 CFR 318 and 381. It is important to use curing methods that achieve uniform distribution of the curing mixture in the meat or poultry product. B.

Deﬁnitions

Cured meat and poultry can be divided into three basic categories: (1) uncomminuted smoked products, (2) sausages, and (3) uncomminuted unsmoked processed meats. 1. 2.

3.

C.

Uncomminuted smoked products. These include bacon, beef jerky, hams, pork shoulders, turkey breasts, and turkey drumsticks. Sausages. These include both ﬁnely ground and coarse ground products. Finely ground sausages include bologna, frankfurters, luncheon meats and loaves, sandwich speads, and viennas. Coarse ground sausages include chorizos, kielbasa, pepperoni, salami, and summer sausages. Cured sausages may be categorized as Raw, cured Cooked, smoked Cooked, unsmoked Dry, semidry, or fermented Uncomminuted, unsmoked processed products. These include corned beef, pastrami, pig’s feet, and corned tongues. This category of products may be sold as either raw ready-to-cook or ready-to-eat.

Incorporation of Cure Ingredients

Regardless of preparation method, cure ingredients must be distributed throughout the product. Cure ingredients may be introduced into sausage products during mixing or comminution. Proper and thorough mixing is necessary whether the cure is added to the formulation in dry or solution form. Muscle cuts may be cured by immersion into a curing (pickling) solution. These methods depend on slow diffusion of the curing agents through the product. Products must be properly refrigerated during immersion curing. Several methods may be used to shorten curing times. These include hot immersion curing greater than 49.2°C (120°F), injection by arterial pumping (e.g., hams), and stitch pumping by a series of hollow needles. If the injection method is used, injection needles must be frequently monitored during processing to ensure that they are not fouled or plugged. Tumbling or massaging may also be used as an aid to hasten curing. Proper sanitation must be observed to prevent contamination during this operation. The dry curing method, a similar process, may also be used. In this case, curing ingredients are rubbed over cuts and surfaces of meat held under refrigeration. Precautions must include wearing sanitary gloves when meat is handled. Product temperature maintenance is critical. D.

Smoking

Smoking is the process of exposing meat products to wood smoke. Depending on the method, some products may be cooked and smoked simultaneously, smoked and dried © 2003 by Marcel Dekker, Inc.

without cooking, or cooked without smoking. Smoke may be produced by burning wood chips or by using an approved liquid smoke preparation. Liquid smoke preparations may also be substituted for smoke by addition directly onto the product during formulation in lieu of using a smokehouse or another type of smoking vessel. As with curing operations, a standard operating procedure must be established to prevent contamination during the smoking process. E.

Fermentation and Dehydration

Meat may be fermented or dehydrated for preservation. The purpose of fermentation is to reduce the pH to below 4.6 and inhibit bacteria harmful to health as well as bacteria that can cause spoilage. Meat products may also be cured and then dehydrated to prevent germination and growth of bacterial spores. Many fermented and dehydrated meats are made without a cooking step. Sanitary practices in the production of these products are extremely important because Staphylococcus aureus can be introduced; S. aureus produces an enterotoxin that is heat stable and thus will not be inactivated by subsequent cooking. Processed pork products require treatment to destroy Trichinella spiralis. At retail products that contain raw pork and that are not subsequently cooked must be produced from certiﬁed trichina-free pork or treated to destroy trichinae. USDA regulation 9 CFR 318.10(c)(3) establishes various requirements for destroying trichinae in pork by heating, freezing, drying, or smoking. Some fermented and dry-cured products are processed without cooking. The labeling for these products should include instructions to the consumer to cook thoroughly before consumption. F.

Recommendations for Safe Curing of Meat and Poultry 1. Posting of acceptable products. A list of products approved by the regulatory authority, or by an approved knowledgeable authority on curing acceptable to the regulatory authority, must be posted in the processing area of the establishment. 2. Employee training. Employees assigned to cure meat or poultry must demonstrate familiarity with these guidelines and the potential hazards associated with curing foods. A description of the training and course content provided to the employees must be available for review by the regulatory authority. 3. HACCP. A HACCP plan is needed for all curing operations. The following recommendations must be met to cure meat and poultry products in the establishment: a. Critical control points. The following are critical control points to be addressed: Purchase of prepared cure mixes or, if cure mixes are blended on the premises instead, carefully controlled mixing using calibrated weighing devices. Storage of cure ingredients in a dry location. Cure must be discarded if the package is wet or appears to have been wetted. b. Raw material handling. Thawing must be monitored and controlled to ensure thoroughness and to prevent temperatute abuse. Improperly thawed meat could cause insufﬁcient cure penetration. Temperature abuse can cause spoilage or growth of pathogens. Meat must be fresh. Curing may not be used to salvage meat that has excessive bacterial growth or spoilage.

© 2003 by Marcel Dekker, Inc.

c. Formulating, preparation, and curing. A formulation and preparation procedure must be documented. All equipment and utensils must be cleaned and sanitized. Pieces must be prepared to uniform sizes to ensure uniform cure penetration. This is extremely critical for dry and immersion curing. Calibrated scales must be used to weigh ingredients. A schedule or recipe must be established for determining the exact amount of curing formulation to be used for a speciﬁed weight of meat or meat mixture. Methods and procedures must be strictly controlled to ensure uniform cure. Mixing of curing formulation with comminuted ingredients must be controlled and monitored. All surfaces of meat must be rotated and rubbed at intervals of sufﬁcient frequency to ensure cure penetration when a dry curing method is used. Immersion curing requires periodic mixing of the batch to facilitate uniform curing. The application of salt during dry curing of muscle cuts requires that the temperature of the product be strictly controlled between 35°F (1.67°C) and 45°F (7.22°C). The lower temperature is set for the purpose of ensuring cure penetration and the upper temperature is set to limit microbial growth. Refer to USDA regulation 9 CFR 318.10(c)(3)(iv) for speciﬁc details on dry curing. Curing solutions must be discarded daily unless they remain with the same batch of products during its entire curing process. Injection needles must be inspected for plugging when such pumping or artery pumping of muscle cuts is performed. Sanitary casings must be provided for sausage, chub, or loaf forming. Casings may not be stripped for reuse in forming additional chubs or sausage from batch to batch. Hot curing of bacon bellies, hams, or any other products must be performed at ⬎120°F (48.89°C), as speciﬁed in 9 CFR 318. d. Cooking and/or smoking. When smokehouses are initially installed or structurally modiﬁed, calibration of product heating characterisitics must be ascertained by competent food technologists. Tests should be run with full range of anticipated product loading. Veriﬁcation of even airﬂow and moisture should be recorded in operational records of the smokehouse for these various loads. Procedures should be documented for opening and closing combinations of vents and drains which are required during each speciﬁc smokehouse operation. Procedures for delivering the appropriate thermal treatment of cooked meats in conformance with the Food Code must be developed and used (also see 9 CFR 318.17 and 318.23 for USDA requirements for meat products). A minimum of 165°F (73.89°C) should be used for cured poultry products. • Cooking equipment that provides even temperature control of the heating medium must be used. • Products must be adequately separated to prevent overlap in the cooking © 2003 by Marcel Dekker, Inc.

media whether immersed in hot water, sprayed with hot water, steamed, or oven heated. • Calibrated temperature measuring devices must be used for determining internal product temperatures. • Temperature measuring device probes must be sanitized to prevent contaminating products when internal temperature are measured. • Calibrated temperature measuring devices must be used for measuring temperatures of the heating medium. • Raw products must be separated from cooked products. • Time/temperature parameters of the cooking process must be monitored and recorded. In some processes the heating medium temperature should also be monitored. e. Cooling. Cooling must be done in accordance with recommendations in the Food Code or under a variance. USDA Cooling Guideline, FSIS Directive 7110.3 (special procedures for cured products), provides speciﬁc guidance. Written cooling procedures must be established. Chill water used in water sprays or immersion chilling which is in direct contact with products in casings or products cooked in an impervious package must be properly chlorinated. Chill water temperature must be monitored and controlled. Chill water may not be reused until properly chlorinated. Reclaimed chill water must be discarded daily. Product must be placed in a manner that allows chilled water or air to uniformly contact the product for assurance of uniform cooling. Internal temperatures must be monitored during cooling by using calibrated temperature measuring devices. Adequate cooling medium circulation must be maintained and monitored. Temperature of the cooling medium must be monitored and recorded in accordance with a written procedure. Handling of product must be minimized during cooling, peeling of casing, and packaging. Sanitary gloves must be used in these procedures. f. Fermentation and drying. Temperature and time must be controlled and logs must be maintained that record the monitoring of this process. Humidity must be controlled by use of a humidistat. Monitoring of the process must be recorded in a written log. Product must be kept separated to allow adequate air circulation during the process. Use of an active and pure culture must be ensured to effect a rapid pH drop of the product. Use of commercially produced culture is necessary and the culture must be used according to the manufacturer’s instructions. Determination of the pH of fermented sausages at the end of the fermentation cycle must be recorded. Handling of products must be minimized and only done with sanitary gloves or sanitized utensils. Dry (unfermented) products may not be hot smoked until the curing and drying procedures are completed. © 2003 by Marcel Dekker, Inc.

4.

5.

Semi-dry fermented sausage must be heated after fermentation to a time/ temperature sufﬁcient to control growth of pathogenic and spoilage organisms of concern. Dedicated area restricted access. All aspects of curing operations must be conducted in an area speciﬁcally designated for this purpose. There must be an effective separation to prevent cross-contamination between raw and cooked foods or cured and uncured foods. Access to processing equipment shall be restricted to responsible trained personnel who are familiar with the potential hazards inherent in curing foods. Equipment cleaning and sanitizing. The procedure for cleaning and sanitization must be accomplished according to instructions given in the Food Code.

REFERENCE 1. FDA. Food Code, 2001. Recommendations of the United States Public Health Service. Washington, DC: U.S. Department of Health and Human Services, 2001.

© 2003 by Marcel Dekker, Inc.

35 FDA Enforcement and Food Plant Sanitation PEGGY STANFIELD Dietetic Resources, Twin Falls, Idaho, U.S.A.

I.

BACKGROUND

The U.S. Food and Drug Administration (FDA) is charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws. What does it do when there is a health risk associated with a food product? When a problem arises with a product regulated by FDA, the agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, legal remedies include asking the manufacturer to recall a product, having federal marshals seize products if a voluntary recall is not done, and detaining imports at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties—including prison sentences—are sought. However, the FDA is aware that it has legal responsibility to keep the public informed of its regulatory activities. To do so, the FDA uses press releases and fact sheets. The FDA uses this tool before, during, and after an event of health hazard related to a food product. Some of these are brieﬂy described herein, emphasizing the sanitation deﬁciencies of affected food products. A. Press Releases and Fact Sheets FDA Talk Papers are prepared by the press ofﬁce to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. © 2003 by Marcel Dekker, Inc.

For example, on April 27, 2001, the FDA issued the following press release and talk paper: Solgar vitamin and herb company recalls Solgar’s Digestive Aid 100’s dietary supplements because of possible salmonella contamination. Solgar Vitamin and Herb Company of Leonia, New Jersey, is recalling 754 bottles of Solgar’s Digestive Aid 100’s dietary supplements, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis. Bottles of Solgar’s Digestive Aid 100’s were distributed from March 30, 2001, to April 20, 2001, to retail stores nationwide and in some foreign countries, including the United Kingdom, France, and Israel. The product comes in brown bottles with yellow labels that have an orange stripe on the bottom. The bottles being recalled are marked with lot numbers 31993 or 30957 that are printed above the expiration date on the bottle neck. The label reads in part ‘‘Solgar Digestive Aid—Dietary Supplement—100 Tablets—Sugar and Starch Free.’’ No illnesses from this product have been reported to date. The recall was the result of a routine sampling program by American Laboratories Inc., of Omaha, Nebraska, which detected Salmonella in the raw material, pepsin, that was used in Solgar’s dietary supplement. FDA’s investigation of the situation continues. Consumers who purchased this product are urged to not consume it and should instead destroy it or return it to the place of purchase for a full refund.

The regulatory tools used by the FDA are described in the following sections.

II. DATA ON INSANITARY PRACTICES For the FDA to enforce its laws and regulations, it must have speciﬁc data regarding the sanitary practices of a food processing plant. The FDA has a number of ways to ascertain or determine if a food product is associated with unsanitary conditions in a food processing plant or if a food processing plant has sanitary deﬁciencies. They include 1. 2. 3. 4. A.

Product monitoring Activities based on reports from the public Activities based on reports from other government agencies Establishment inspection reports

Product Monitoring

Product monitoring is as old as when modern food processing ﬁrst started. At present, local, county, state, and federal health authorities conduct market food product sampling and analyses to determine the wholesomeness of food. Such monitoring is restricted by the availability of allocated budget and resources. However, the FDA has the most resources and its monitoring effort produces the most results. When products are found to be unsanitary (from pathogens, rats, insects, glass, metal, etc.) by the FDA, it will implement standard procedures to warn the public, remove © 2003 by Marcel Dekker, Inc.

such products from the market, and take a variety of other actions it can do and which will be discussed later in this chapter. B. Activities Based on Reports from the Public The FDA has a website and an 800 number for the public to report health hazards, including sanitation of food products. Since the establishment of such communication convenience, there is an increasing number of consumers reporting products posing health risks, such as glass in baby food, dead insects in frozen dinners, and so on. Occasionally, socalled whistle blowers, i.e., employees of food companies, inform the FDA of products with contaminants from unsanitary practices. Based on the data provided by the public, the FDA implements standard procedures to handle any potential health hazards related to the products reported. C. Activities Based on Reports from Other Government Agencies Health care providers frequently are the source of information that eventually leads to unsanitary practices of food companies. These people include physicians, pharmacists, nurses, dentists, public health personnel, and others. Most of these reports involve injury such as food poisoning or decomposed or spoiled product contents. Their reports become a vital source of leads for the FDA to enforce its laws and regulations. D. Establishment Inspection Reports Inspection of a food processing plant by a government authority is the basis on which the government can decide if the food manufactured in the plant is wholesome and poses no economic fraud. The frequency and intensity of the inspection process will depend on resources and budgets, especially for the nonfederal agencies. The FDA, as a federal agency, has more authority, greater resources, and a larger budget. The framework for inspecting a plant covers the following: 1. Basics a. Preparation and references b. Inspectional authority 2. Personnel 3. Plants and grounds 4. Raw materials 5. Equipment and utensils 6. Manufacturing process a. Ingredient handling b. Formulas c. Food additives d. Color additives e. Quality control f. Packaging and labeling After an inspection is completed, the inspector gives the plant management a copy of the report. If there are sanitation deﬁciencies, the management will be expected to correct them. © 2003 by Marcel Dekker, Inc.

The data collected from this inspectional procedure and other sources discussed earlier become the central operation base on which the FDA will enforce its legal responsibility to make sure that all deﬁciencies are corrected to reduce any hazard to the health of the consuming public. The interesting part is the enforcement and compliance of the equation that concerns this chapter. We have seen the manner in which the FDA compiles data on the sanitation of a food product and a food processing plant. We will now proceed on the regulatory activities the FDA usees to assure compliance. III. RECALLS The FDA Consumer magazine has published several articles on the recalls of food products in this country. The following information has been compiled from these public documents. A.

Misunderstanding

Recalls are actions taken by a ﬁrm to remove a product from the market. Recalls may be conducted on a ﬁrm’s own initiative, by FDA request, or by FDA order under statutory authority. The recall of a defective or possibly harmful consumer product often is highly publicized in newspapers and on news broadcasts. This is especially true when a recall involves foods, drugs, cosmetics, medical devices, and other products regulated by FDA. Despite this publicity, FDA’s role in conducting a recall often is misunderstood not only by consumers, but also by the news media and occasionally even by the regulated industry. The following headlines, which appeared in two major daily newspapers, are good examples of that misunderstanding: ‘‘FDA Orders Peanut Butter Recall’’ and ‘‘FDA Orders 6,500 Cases of Red-Dyed Mints Recalled.’’ The headlines are wrong in indicating that the agency can order a recall. The FDA has no authority under the Federal Food, Drug, and Cosmetic Act to order a recall, although it can request a ﬁrm to recall a product. Most recalls of products regulated by FDA are carried out voluntarily by the manufacturers or distributors of the product. In some instances, a company discovers that one of its products is defective and recalls it entirely on its own. In others, FDA informs a company of ﬁndings that one of its products is defective and suggests or requests a recall. Usually, the company will comply; if it does not, then FDA can seek a court order authorizing the federal government to seize the product. This cooperation between FDA and its regulated industries has proven over the years to be the quickest and most reliable method to remove potentially dangerous products from the market. This method has been successful because it is in the interest of FDA, as well as industry, to get unsafe and defective products out of consumer hands as soon as possible. The FDA has guidelines for companies to follow in recalling defective products that fall under the agency’s jurisdiction. These guidelines make clear that FDA expects these ﬁrms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. Under the guidelines, companies are expected to notify FDA when recalls are started, to make progress reports to FDA on recalls, and to undertake recalls when asked to do so by the agency. The guidelines also call on manufacturers and distributors to develop contingency plans for product recalls that can be put into effect if © 2003 by Marcel Dekker, Inc.

and when needed. The FDA’s role under the guidelines is to monitor company recalls and assess the adequacy of a ﬁrm’s action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. The FDA has stated the following guidelines several times in its magazine FDA Consumer. B. Categories The guidelines categorize all recalls into one of three classes according to the level of hazard involved. Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Class II recalls are for products that might cause a temporary health problem or pose only a slight threat of a serious nature. Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA regulations. The FDA develops a strategy for each individual recall that sets forth how extensively it will check on a company’s performance in recalling the product in question. For a Class I recall, for example, FDA would check to make sure that each defective product has been recalled or reconditioned. In contrast, for a Class III recall the agency may decide that it only needs to spot check to make sure the product is off the market. Detailed regulations have been promulgated on FDA recalls in the U.S. Code of Federal Regulations. Even though the ﬁrm recalling the product may issue a press release, FDA seeks publicity about a recall only when it believes the public needs to be alerted about a serious hazard. For example, if a canned food product purchased by a consumer at a retail store is found by FDA to contain botulinum toxin, an effort would be made to retrieve all the cans in circulation, including those in the hands of consumers. As part of this effort the agency also could issue a public warning via the news media to alert as many consumers as possible to the potential hazard. The FDA also issues general information about all new recalls it is monitoring through a weekly publication titled ‘‘FDA Enforcement Report.’’ Before taking a company to court, FDA usually notiﬁes the responsible person of the violation and provides an opportunity to correct the problem. In most situations, a violation results from a mistake by the company rather than from an intentional disregard for the law. There are several incentives for a company to recall a product, including the moral duty to protect its customers from harm and the desire to avoid private lawsuits if injuries occur. In addition, the alternatives to recall are seizures, injunctions, or criminal actions. These are often accompanied by adverse publicity, which can damage a ﬁrm’s reputation. A company recall does not guarantee that FDA will not take a company to court. If a recall is ineffective and the public remains at risk, FDA may seize the defective products or obtain an injunction against the manufacturer or distributor. The recalling ﬁrm is always responsible for conducting the actual recall by contacting its purchasers by telegram, mailgram, or ﬁrst-class letter with information including © 2003 by Marcel Dekker, Inc.

1. 2. 3. 4.

The product being recalled Identifying information such as lot numbers and serial numbers The reason for the recall and any hazard involved Instructions to stop distributing the product and what to do with it

The FDA monitors the recall, assessing the ﬁrm’s efforts.

C.

Initiating a Recall

A ﬁrm can recall a product at any time. Firms usually are under no legal obligation even to notify FDA that they are recalling a defective product, but they are encouraged to notify the agency, and most ﬁrms seek FDA’s guidance. FDA may request a recall of a defective product, but it does so only when agency action is essential to protect the public health. When a ﬁrm undertakes a recall, the FDA district ofﬁce in the area immediately sends a ‘‘24 Hour Alert to Recall Situation’’ notifying the relevant FDA center (responsible for foods and cosmetics, drugs, devices, biologics, or veterinary medicine) and the FDA’s Division of Emergency and Epidemiological Operations (DEEO) of the product, recalling ﬁrm, and reason for the recall. FDA also informs state ofﬁcials of the product problem, but for routine recalls the state does not become actively involved. After inspecting the ﬁrm and determining whether there have been reports of injuries, illness, or other complaints to either the company or to FDA, the district documents its ﬁndings in a recall recommendation (RR) and sends it to the appropriate center’s recall coordinator. The RR contains the results of FDA’s investigation, including copies of the product labeling, FDA laboratory worksheets, the ﬁrm’s relevant quality control records, and when possible a product sample to demonstrate the defect and the potential hazard. The RR also contains the ﬁrm’s proposed recall strategy.

D.

The Strategy

The FDA reviews the ﬁrm’s recall strategy (or, in the rare cases of FDA-requested recalls, drafts the strategy), which includes three things: the depth of recall, the extent of public warnings, and effectiveness check levels. The depth of recall is the distribution chain level at which the recall will be aimed. If a product is not hazardous, a recall aimed only at wholesale purchasers may sufﬁce. For more serious defects, a ﬁrm will conduct a recall to the retail level. And if the public health is seriously jeopardized, the recall may be designed to reach the individual consumer, often through a press release. But most defects don’t present a grave danger. Most recalls are not publicized beyond their listing in the weekly Enforcement Report mentioned earlier. This report lists the product being recalled, the degree of hazard (called ‘‘classiﬁcation’’), whether the recall was requested by FDA or initiated by the ﬁrm, and the speciﬁc action taken by the recalling ﬁrm. A ﬁrm is responsible for conducting ‘‘effectiveness checks’’ to verify—by personal visits, by telephone, or with letters—that everyone at the chosen recall depth has been notiﬁed and has taken the necessary action. An effectiveness check level of A (check of 100% of people that should have been notiﬁed) through E (no effectiveness check) is speciﬁed in the recall strategy, based on the seriousness of the product defect. © 2003 by Marcel Dekker, Inc.

E.

The Health Hazard Evaluation

When the center receives the RR from the district ofﬁce, it evaluates the health hazard presented by the product and categorizes it as Class I, II, or III. The classiﬁcation is determined by an ad hoc Health Hazard Evaluation Committee made up of FDA scientists chosen for their expertise. Classiﬁcation is done on a case-by-case basis, considering the potential consequences of a violation. A class I recall involves a strong likelihood that a product will cause serious adverse health consequences or death. A very small percentage of recalls are Class I. In December of 2000, Schneider Cheese, Inc. (Waldo, WI) recalled several kinds of cheese including Schneider String Cheese (mozzarella cheese). This was a Class I recall because the product was contaminated with Listeria monocytogenes. A class II recall is one in which use of the product may cause temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote. An example of Class II is the following. In March 2001, Alpete Meats (Muncie, IN) recalled meat-free/veggie corn dogs because the products may have been manufactured using an ingredient which appeared to contain the genetic material (DNA) necessary for the production in corn (trade name StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption. A Class III recall involves a product not likely to cause adverse health consequences. In March 2001, H. R. Davis Candy Company (Canton, OH) recalled Coconut Dips milk chocolate, sugar-free candy because they contained undeclared sulﬁtes. For Class I and II, and infrequently for class III, FDA conducts audit checks to ensure that all customers have been notiﬁed and are taking appropriate action. The agency does this by personal visits or telephone calls. A recall is classiﬁed as ‘‘completed’’ when all reasonable efforts have been made to remove or correct the product. The district notiﬁes a ﬁrm when FDA considers its recall completed. F.

Planning Ahead

The FDA recommends that ﬁrms maintain plans for emergency situations requiring recalls. Companies can minimize the disruption caused by the discovery of a faulty product if they imprint the date and place of manufacture on their products and keep accurate and complete distribution records. A ‘‘market withdrawal’’ is a ﬁrm’s removal or correction of a distributed product that involves no violation of the law by the manufacturer. A product removed from the market due to tampering, without evidence of manufacturing or distribution problems, is one example of a market withdrawal. A ‘‘stock recovery’’ is another action that may be confused with a recall. A stock recovery is a ﬁrm’s removal or correction of a product that has not yet been distributed. Even though the ﬁrm recalling the product may issue a press release, FDA seeks publicity about a recall only when it believes the public needs to be alerted about a serious hazard. For example, if a canned food product purchased by a consumer at a retail store is found by FDA to contain botulinum toxin, an effort would be made to retrieve all the cans in circulation, including those in the hands of consumers. As part of this effort the agency also could issue a public warning via the news media to alert as many consumers as possible to the potential hazard. © 2003 by Marcel Dekker, Inc.

G.

Examples of Recalls

The following describes three examples of recalls. 1. Class I Recall Product: cold smoked sea bass, air-packed in cardboard boxes; recall #F-313-1 Code: sb 0110 Manufacturer: Haifa Smoked Fish Inc., Jamaica, NY Recalled by: manufacturer, by telephone and letter on 2/15/01; FDA-initiated recall complete Distribution: Rego Park, NY (Queens) Quantity: 231.4 lb Reason: product contaminated with Listeria monocytogenes Reference: April 4, 2001, FDA Weekly Enforcement 2. Class II Recall Product: Kraft EasyMac Microwavable Single Servings Macaroni & Cheese Dinner; 3/4 cup individual serving laminate twin-packets, packaged in 6-count boxes, UPC 21000-67148, and 18-count boxes, UPC 21000-67149; recall #F-306-1 Code: code dates SEP-05-01 through SEP-26-01. These dates are followed by either a 1 or 2, then XCN and military time Manufacturer: Cloud Corp., Des Plaines, IL Recalled by: Kraft Foods, Inc., Northﬁeld, IL, by fax/e-mail on 2/6/01; ﬁrm initiated recall complete Distribution: Nationwide Quantity: 142,181.5 case equivalents Reason: product contaminated with a compressed air system lubricant Reference: April 4, 2001, FDA Weekly Enforcement 3. Class III Recall Product: Colonial Kitchen Bacon Bits; recall #F-271-1 Code: 08K3080, 06W3060, 09K3110, 09W3110, 08W3080, 08K3090, 09K3150, 09W3150 Manufacturer: Feaster Foods, Omaha, NE Recalled by: Dollar Tree Stores, Inc., Chesapeake, VA, by phone on/about 12/5/ 2000; completed recall resulted from follow-up by the New York State Department of Agriculture and Markets Distribution: PA, IL, MS, and VA Quantity: 42552 bottles Reason: product contained undeclared FD&C Red No. 40 and is not identiﬁed as an imitation bacon product Reference: March 7, 2001, FDA Weekly Enforcement

IV. WARNING LETTERS Under FDA regulations, a prior notice is a letter sent from FDA to regulated companies about regulatory issues. One such notice is the warning letter. If the establishment inspec© 2003 by Marcel Dekker, Inc.

tion report includes a list of sanitary deﬁciencies, the FDA may send a warning letter to the food company to ask for proper correction of such deﬁciencies. Two such letters are provided here. However, the following premise must be realized. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. A. Insanitary Practices in a Potato Plant On June 7, 2001, the FDA issued a warning letter to a potato processing plant. The major contents of the letter are presented here. The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at May 3, 4, and 9, 2001. The inspection revealed signiﬁcant insanitary practices and conditions which cause your foods to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with ﬁlth. You are responsible for ensuring that your facility has the proper construction and design and that your processes, controls, and procedures are adequate to store and process food under sanitary conditions. The following is a list of the insanitary practices, conditions, and ﬁndings observed by FDA: 1. Sanitary operations a. Pest control: You are not taking effective measures to exclude pests from your plant, as evidenced by the following: i. A decomposed rat, approximately 10 inches long, was found near bags of sodium metabisulﬁte. ii. Sixteen (16) rodent pellets, conﬁrmed by FDA laboratory analysis, were found at various locations in the raw ingredients room. iii. Six (6) decomposed mice were found near a pallet holding an opened box of food-packaging poly bags in your miscellaneous materials room (called junk room by the FDA investigator). iv. Approximately twenty (20) rodent pellets, eight of which were conﬁrmed by FDA laboratory analysis, were found at the west side of the miscellaneous materials room. b. General Maintenance: You are not taking effective measures to maintain the building, ﬁxtures, and other physical facilities of the plant in a sanitary condition, as evidenced by the following: i. Two live spiders were found in the northeast corner of the raw ingredient room, next to an uncovered wooden bin ﬁlled with raw potatoes. ii. An uncovered wooden bin of raw potatoes and bagged raw ingredients were stored over wooden ceiling, piping, and lighting that were covered with dustlike debris and spider webbing in the raw ingredient room. iii. Scraps of wood and empty cans, covered with dustlike debris and spider webbing, were piled against the walls on the south side of the raw ingredient room. © 2003 by Marcel Dekker, Inc.

iv.

Uncovered plastic bins of boiled potatoes were exposed to ceiling, walls, and ﬂooring that had a build-up of brown-black moldlike material in the walk-in refrigerator. v. The metal casing around the light bulb suspended over bins of uncovered boiled potatoes bore a gray, crustlike material in the walk-in refrigerator. vi. Uncovered plastic bins of cooled potatoes were exposed to moldy ceilings and walls in the shredding/dicing room. vii. Three fans with dusty grills were blowing onto exposed raw potatoes as they were hauled up a conveyor belt in the processing room. viii. There is a build-up of dried potato residue, dust, and debris along the peeled potato line in the processing room. ix. The lighting unit directly above the hand-sorting table was covered with dust and spider webs in the processing room. x. Two cigarette butts and spilled raw ingredients were found behind containers of raw ingredients in the processing room. 2. Plant and grounds a. Plant Construction: Your plant is not constructed in such a manner that ﬂoors, walls, and ceiling may be adequately cleaned and kept clean and in good repair, as evidenced by the following: i. The walls and ceiling in the shredding/dicing room bear a black moldlike substance. ii. The processing room ﬂoor is heavily pitted. iii. The south of the room, formerly known as the french-fry room, has missing concrete and the metal framing is exposed and bears rustlike debris. b. Plant Design: The combination of activities that take place in the processing room increases the potential for contamination of food and food-contact surfaces. Speciﬁcally, the employees’ microwave oven and coffee pot are next to the grill used to test browning of hash browns; employees’ food and drink items were found on the same table as the scale used to weigh ﬁnished product; and employees’ shoes and a box of recycled cans were found directly underneath this table. c. Placement of Equipment and Storage of Materials: i. You do not provide sufﬁcient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations. Speciﬁcally, bins of uncovered raw potatoes, miscellaneous equipment, wooden shelving, and pallets of raw ingredients were ﬂush against the walls, preventing access to cleaning and maintaining rodent traps. ii. You do not take proper measures to ensure that drip or condensate from ﬁxtures, ducts, and pipes does not contaminate food-contact surfaces. Speciﬁcally, the food shredder was stored beneath a refrigeration unit that was leaking condensation. 3. Sanitary facilities and controls a. Plumbing: You do not provide adequate ﬂoor drainage in areas where normal operations discharge water on the ﬂoor, as evidenced by the following: i. In the raw ingredient room, a ﬁve-gallon bucket ﬁlled with water and a ﬂoating cigarette butt was observed overﬂowing into the channel drain that leads to a drain underneath wooden bins used to store raw potatoes. The drain had 2 inches of standing dark-colored, sewage-smelling water. An employee identiﬁed the water as condensate from the freezer. © 2003 by Marcel Dekker, Inc.

ii.

4.

5.

6.

7.

In the processing room, there is a channel drain that contained rotten potato peels and up to 1 inch of standing dark-colored water. iii. In the room, formerly known as the french-fry room, the ‘‘sump’’ system was overﬂowing, causing water to back up through the drain channel into the production room. The ﬂooded ﬂoor had a sewage odor. Employees were observed tracking the standing water back and forth from the frenchfry room and the production room. Equipment and utensils a. Design and Material: Equipment and utensils should be so designed and of such material and workmanship as to be adequately cleanable and should be properly maintained. Speciﬁcally, i. The wooden ceiling, walls, and ﬂoor bear a build-up of brown-black moldlike material. ii. The bins used for storing raw potatoes are wooden and have moldlike material on the interior and exterior sides as well as the interior base. Maintenance a. Equipment should be maintained so as to facilitate cleaning. b. Speciﬁcally, the walk-in refrigerator’s forced air cooling unit had peeling paint chips and was blowing debris near uncovered plastic bins of boiled potatoes. c. Seams on food-contact surfaces should be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter. Speciﬁcally, the conveyor belt in the processing room had uneven seams and had a darkcolored, moldlike build-up. d. Proper Cleaning: Your food equipment is washed using a sodium hypochlorite solution, but there is no water rinse afterwards. Proper cleaning includes a ﬁnal rinse with clean water. Processes and controls a. Potential for Contamination of Food and Food-Contact Surfaces: You do not take proper precautions to reduce the potential for contamination of food and foodcontact surfaces with ﬁlth or other extraneous material, as evidenced by the following: i. In the walk-in refrigerator, uncovered plastic bins of boiled potatoes were stored approximately 2 feet from the forced air cooling unit, which was blowing rustlike debris. There were also two drums overﬂowing with water, which an employee identiﬁed as condensate, underneath the unit. ii. In the walk-in refrigerator, a fan grill covered with rustlike debris was stored in a plastic bin designated to store boiled potatoes for cooling. iii. The maintenance room, where the forklift, lubricants, tools, and other miscellaneous equipment are stored, directly opens to the hand-sorting table in the production room. iv. You are not taking effective measures to protect against the inclusion of metal or other extraneous material in the raw potatoes or ﬁnished product. b. Temperature of Walk-In Refrigerator: You are neither performing routine temperature checks nor maintaining records of the temperature of the walk-in refrigerator. Also, there is no automatic regulating control of the temperature. Personnel a. Cleanliness: You do not assure that your employees conform to hygienic practices

© 2003 by Marcel Dekker, Inc.

while on duty to the extent necessary to protect against contamination of food, as evidenced by the following: i. Employees did not wash their hands after eating or drinking and returning to the production line. ii. No hand sanitizers are installed in the production area. iii. An employee was observed driving the forklift, doing general plant maintenance, and blowing his nose, but not washing his hands prior to unloading/ loading ﬁnished product into delivery vans. At the conclusion of the inspection, the insanitary practices and conditions were listed on Form FDA 483 (Inspectional Observations) and discussed with you. A copy of this form is enclosed for your ready reference. This list is not meant to be an all-inclusive list of violations. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice. These include seizure and/or injunction. Please advise FDA in writing, within ﬁfteen (15) working days of receipt of this letter, of the speciﬁc steps you have taken to correct the noted violations. If corrective action cannot be completed within 15 days, state the reasons for the delay and the time at which the corrections will be completed. Your response should be directed to . B.

Unsanitary Prepackaged Sandwiches

On June 1, 2001, the FDA issued a warning letter to a food plant that produces prepackaged sandwiches. The major contents of this letter are presented here. During an inspection of your manufacturing facility, located at conducted May 14 and 15, 2001, we found that you manufacture and distribute ready-to-eat food products, including prepackaged sandwiches. During the inspection, we collected a number of samples including unopened ingredients, sliced meats and cheeses, and ﬁnished products. Our analysis of these samples revealed Listeria monocytogenes (L. mono) contamination as follows: 1.

2.

3.

We isolated L. mono from ﬁnished retail units of turkey and chedder cheese submarine sandwiches (FDA Sample Number 133746) and turkey, ham, and cheese submarine sandwiches (FDA sample number 133745). We isolated L. mono from ham (FDA Sample Number 133739), chedder cheese (FDA Sample Number 133740), and provolone cheese (FDA Sample Number 133741), which were sliced at your facility to be used in the preparation of your ﬁnished sandwiches. Our analysis of bulk, unopened units of ham (FDA Sample Number 133742), chedder cheese (FDA Sample Number 133743), and provolone cheese (FDA Sample Number 133744), in storage at your facility, showed no L. mono contamination. Listeria monocytogenes is a pathogenic organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, Listeria infection can cause miscarriages

© 2003 by Marcel Dekker, Inc.

and stillbirths among pregnant women. Therefore, the products listed in items 1 and 2 above are adulterated under section 402(a)(1) of the Food, Drug, and Cosmetics Act (the Act) because they are contaminated with the pathogenic bacteria Listeria monocytogenes, which may render the product injurious to health. We note that you are conducting a recall of products from the marketplace and acknowledge your action in this regard. We further note that the U.S. Army notiﬁed you in May 2001 that they had isolated L. monocytogenes from your ham and turkey and turkey and cheddar sandwiches sampled in April 2001. You were also recently notiﬁed that L. mono was isolated from several other sandwiches collected by the U.S. Army in May 2001, including your ham and cheese, ham and turkey, pastrami and cheese, French dip, roasted turkey croissant, tuna salad croissant, chicken pesto pita, tuna pita, and turkey pita. The repeat nature of the Listeria monocytogenes contamination of your food products, as evidenced by the U.S. Army and FDA test results, along with the negative sample results associated with the incoming food ingredients used to manufacture your products, indicates that you have a widespread problem with Listeria monocytogenes. In addition, we also observed inappropriate food handling and sanitation practices as outlined at the conclusion of the inspection on the Form FDA-483 issued to . Based on these insanitary practices, along with the U.S. Army test results from April and May 2001, and the FDA sample results describing Listeria monocytogenes contamination of your sandwiches described above, we regard all products prepared, packed, or held at your facility to be adulterated within the meaning of Section 402(a)(4) of the Act. Among the signiﬁcant ﬁndings described on the Form FDA-483 is the observation that the temperature of your cold storage room ﬂuctuated from 48 to 50°F from 11:30 a.m. to 3:30 p.m. on May 14, 2001. This high temperature may not prevent the rapid growth of undesirable microorganisms. Test results supplied to you by the U.S. Army in May 2001 indicate that some of your products are not only contaminated with L. mono, but also have high levels of aerobic bacteria (⬎600,000,000 cfu/g), coliforms (50,000 cfu/g), and/or E. coli (up to 11,000 cfu/g), which are further indications of insanitary practices and/or conditions at your facility. The above identiﬁcation of violations is not intended to be an all-inclusive list of deﬁciencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the federal regulations. Moreover, it is your responsibility to produce safe products. You should take prompt action to prevent further violation of the Act. Further violation of the Act may result in regulatory action without further notice, which can include seizure of your products and/or injunction of your ﬁrm. Please notify this ofﬁce in writing within 15 working days of receipt of this letter of the speciﬁc actions taken to correct the noted violations and prevent their recurrence. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed. Your written response should be directed to the attention of . Additionally, due to the serious concerns we have over the repeat nature of the listeria contamination, we request that you contact this ofﬁce to schedule a meeting within ﬁve (5) days of receipt of this letter. You may schedule this meeting by calling the district ofﬁce at and arranging a mutually agreeable date and time. © 2003 by Marcel Dekker, Inc.

V.

SUMMARIES OF COURT ACTIONS

Summaries of court actions are given pursuant to Section 705 of the Federal Food, Drug, and Cosmetic Act. Summaries of court actions report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civil actions taken against goods alleged to be in violation, and criminal and injunction proceedings are against ﬁrms or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, or cosmetics alleged to be adulterated or misbranded or otherwise violative of the law when introduced into and while in interstate commerce or while held for sale after shipment in interstate commerce. Summaries of court actions are prepared by the Ofﬁce of the Chief Counsel, Food and Drug Administration and published by direction of the Secretary of Health and Human Services. The September–October issue of the FDA Consumer magazine reported the following summaries of court actions regarding foods that were seized because of unsanitary conditions. A.

Case 1 Product: Articles of food, dusting starch, seized at Norfolk, VA (E.D. Va.); Civil Action No. 2:99cv1130. Charged 7-16-99: While held for sale after shipment in interstate commerce at Golden Fields Enterprises, Inc. (Norfolk, VA), the articles of food were adulterated in that they had been prepared, packed, and held under insanitary conditions whereby they might have become contaminated with ﬁlth—402(a)(4). Disposition: Pursuant to default decree of condemnation, forfeiture, and destruction, the articles of food were destroyed December 17, 1999. (F.D.C. No. 67278; S. No. 48739 et al.; S.J. No. 1.)

B.

Case 2 Product: Beef trachea, three cases more or less, seized at Greeley, CO (D. Colo.); Civil Action No. 99-Z-2398. Charged 12-16-99: While held for sale after shipment in interstate commerce at Old West Treat Company, in (Greeley, CO), the article of food was adulterated in that it bore or contained Salmonella, a poisonous and deleterious substance which might have rendered it injurious to health—402(a)(1). Disposition: The article of food was destroyed. (F.D.C. No. 67296; S. No. 57883; S.J. No. 2.)

C.

Case 3 Product: Frozen shrimp, 1192 cases more or less, seized at Jacksonville, FL (M.D. Fla.); Civil Action No. 98-236-Civ-J-20B. Charged 3-16-98: While held for sale after shipment in interstate commerce at Industrial Cold Storage, Inc. and stored at the account of King and Prince Seafood Corporation (Brunswick, GA), the articles of food were all adulterated in that they consisted in whole or in part of a decomposed substance by reason of the presence therein of decomposed shrimp—402(a)(3).

© 2003 by Marcel Dekker, Inc.

Disposition: Pursuant to an order amending the consent decree, a portion of the defendant lot of decomposed frozen shrimp was satisfactorily reconditioned. The rejected portion of the reconditioned product had been destroyed under the supervision of the United States Marshals Service. (F.D.C. No. 67224; S. No. 98-712573; S.J. No. 5.) D. Case 4 Product: Frozen shrimp, 302 cases more or less, seized at Tampa, FL (M.D. Fla.); Civil Action No. 98-476-CIV-T-17C. Charged 3-4-98: While held for sale after shipment in interstate commerce at Americold Corporation, stored to the account of Central Seaway Company, Inc. (Tampa, FL), all of the defendant shrimp were adulterated in that they consisted in whole or in part of a decomposed substance by reason of the presence therein of decomposed shrimp—402(a)(3). Furthermore, certain defendant shrimp (420 cases more or less) were also adulterated in that they consisted in whole or in part of a ﬁlthy substance by reason of the presence therein of insect and bird ﬁlth—402(a)(3). Disposition: The condemned defendant shrimp was exported to Zhejiang Foreign Economic Relations and Trade Development Corporation (Hangzhou, China). (F.D.C. No. 67223; S. No. 98-768-226/228; S.J. No. 6.) E.

Case 5 Product: Preserved turnip, 60 cases more or less, seized at Brooklyn, NY (E.D. N.Y.); Civil Action No. 98-CV-0181. Charged 1-14-98: While held for sale after shipment in interstate commerce at Yick Cheung Corporation, doing business as Goodworld Trading (Brooklyn, NY), the articles of food were adulterated in that the articles (60 case lots of preserved turnips) consisted in part of a ﬁlthy substance, by reason of having been rodentgnawed and by reason of the presence therein of rodent urine—402(a)(3). The articles were further adulterated in that they (all lots) had been held under insanitary conditions whereby they very likely became contaminated with ﬁlth— 402(a)(4). Disposition: The condemned articles of food were successfully reconditioned. (F.D.C. No. 67222; S. No. 98-751-473; S.J. No. 7.)

F.

Case 6 Product: Soybeans and Mung Beans, seized at San Lorenzo, CA (N.D. Calif.); Civil Action No. 99-4799. Charged 11-1-99: While held for sale after shipment in interstate commerce at Dong Ling Sprout and Produce Co. (San Lorenzo, CA), the articles of food were adulterated in that certain articles of food consisted in part of a ﬁlthy substance, including 350 50-lb bag lots of soybeans, by reason of being rodent gnawed; 720 55-lb bag lots of mung beans, by reason of the presence therein of insects and rodent excreta pellets; 1190 110-lb bag lots of mung beans, by reason of the presence therein of rodent hairs; and 2320 55-lb bag lots of mung beans, by reason of the presence therein of mammalian urine—402(a)(3). The articles were further adulterated in

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that all articles of food (all lots) had been held under insanitary conditions whereby they might have become contaminated with ﬁlth—402(a)(4). Disposition: The articles were destroyed. (F.D.C. No. 67290; S. No. 38938 et al.; S.J. No. 8.)

VI. INVESTIGATORS’ REPORTS The Food and Drug Administration Investigators’ Reports refer to selected cases published in FDA Consumer magazine illustrating regulatory and administrative actions—such as inspections, recalls, seizures, and court proceedings—by FDA’s regional and district ofﬁces across the country. Four such reports are described here. A.

‘‘Food Seized at Warehouse Overrun with Rodents’’

The July–August 1998 issue of FDA Consumer magazine carried the above-headlined article by Carol Lewis on legal action against a food warehouse with unsanitary conditions. More than 200 kinds of Oriental food products with a retail value of $280,000 were seized in January of 1998 at a New York City warehouse because of rodent contamination. At FDA’s request, the U.S. District Court for the Eastern District of New York issued a seizure warrant January 26, 1998, for the food—about 5488 cases of imported rice cakes, candies, dried vegetables, and other assorted products—after the food’s owner and distributor, Yick Cheung Corp., doing business as Goodworld Trading Co., refused to rid the Brooklyn warehouse of rodents. ‘‘A seizure can give substantial motivation to those responsible for cleaning up their act,’’ said Lillian Aveta, a compliance ofﬁcer in FDA’s New York district ofﬁce. ‘‘They want to get their facility back into business.’’ Goodworld’s poor sanitary practices were ﬁrst identiﬁed in February 1995 when, as part of a crackdown on misbranded products, New York State authorities inspected the storage facility. In addition to sanitation violations, state chemists detected staphylococcal bacteria in mushrooms Goodworld had for sale. The state seized more than 1000 cases of mushrooms and cited Goodworld for sanitation violations. Subsequent inspections later that year found continuing sanitation problems and resulted in further seizures and ﬁnes of more than $1500. But the violations continued. As part of a routine schedule, FDA inspected Goodworld in October. In repeated visits through December, FDA investigators Cornelius Gallagher, Peter Caparelli, Kwong Lee, and Donald Ullstrom observed a dog roaming freely within the food storage area, fresh rodent pellets ‘‘too numerous to count’’ throughout the walk-in refrigerator, cases of food that looked like they had been gnawed, and gnawed holes through the base of the north and west walls of the warehouse. Food samples collected and later analyzed by FDA indicated rodent contamination. Company president Wing Chan told FDA that garbage was picked up once weekly and that the company acted as its own exterminator, using a BB gun and placing unenclosed rodenticide on the ﬂoor throughout the warehouse. On November 7, FDA investigators, along with FDA chemist Nariman Ayyad, met New York State inspector Sonia Morales at the warehouse. New York State is under contract with FDA to assist with some inspections. Morales placed all food lots sampled © 2003 by Marcel Dekker, Inc.

by FDA under state embargo to ensure that the food items in question would not be distributed while the seizure was being processed. At a December 3 follow-up inspection, agency investigators noted that previously documented building deﬁciencies had not been corrected. Company president Chan told FDA that he rented the warehouse from the owner who, he said, was looking to sell the property. He also said that if the property was not sold within 6 months, he ‘‘may make the building corrections’’ himself. Until then, he said, he intended to leave the building deﬁciencies ‘‘as is’’ for ﬁnancial reasons, Aveta said. The agency can order a warrant for mass seizure based on six violative lots of food, Aveta said. She added that Goodworld was in violation with a total of nine lots of food. The seizure on January 26, 1998, only affected products in soft packaging because other types of containers used had not been found to be contaminated. At press time, the company was allowed to distribute only products packaged in rigid containers, such as metal and hard plastic, as well as in soft packages received after the seizure date. B. ‘‘Imported Fruit Blamed for Rare Typhoid Outbreak’’ The July–August 1999 issue of FDA Consumer magazine carried the above-headlined article by John Henkel on legal action against imported fruit responsible for typhoid outbreak in this country. A tropical fruit popular in Hispanic American homes was the source of a recent outbreak of a disease rarely seen in the United States: typhoid fever. Health ofﬁcials believe that frozen mamey fruit from Central America contaminated with potentially dangerous bacteria caused 14 cases of typhoid in the Miami area between December 1998 and February 1999. All of the sickened people, who required hospitalization, reportedly recovered. Though the products also were sold elsewhere in the United States, no other related typhoid cases were reported. Federal and state ofﬁcials removed the fruit from circulation in February and March, preventing any further sickness. Typhoid, a primarily waterborne infection caused by the bacterium Salmonella typhi, produces persistent and high fever, abdominal cramps, loss of appetite, and fatigue. Though potentially life threatening, the disease normally can be cured if treated promptly with antibiotics. Hispanic households use frozen mamey (pronounced mam-may) to make a shakelike drink called batidos de mamey. The products have not caused any reported problems in the past. In Florida, the clustered cases puzzled health ofﬁcials because the disease is rare in the United States. When it shows up, it is usually in travelers returning from a visit abroad. But an investigation by state authorities and the national Centers for Disease Control and Prevention showed that those sickened had not traveled. ‘‘There were just too many clustered cases to attribute to travelers,’’ says Mike Chappell, investigations director in FDA’s Florida district ofﬁce. ‘‘Those numbers of clustered cases could be explained by a traveling group: for example, a group of ﬁreﬁghters who travel to Guatemala. After drinking contaminated water, some of them come back and then develop typhoid fever. But that wasn’t the case with this outbreak.’’ So in early February, Florida Health Department and CDC ofﬁcials focused their © 2003 by Marcel Dekker, Inc.

efforts on ﬁnding the common elements of the cluster of cases showing up in the Miami area. They determined that in all the cases the people had consumed frozen mamey either at home, where it had been bought from a food store, or in a restaurant. Florida ofﬁcials immediately embargoed the fruit to keep it from being distributed. Having pinpointed the outbreak cause, ofﬁcials set out to trace the origin of the contaminated fruit. The FDA joined the investigation on February 18 and, by evaluating data provided by state health ofﬁcials and CDC, identiﬁed El Sembrador brand frozen mamey produced in Guatemala and possibly Honduras as the most likely source. Epidemiological data from South Florida showed that this brand was in homes and in restaurants where those exposed ate the product. On February 20, FDA publicly warned consumers not to eat the El Sembrador brand of frozen mamey. The FDA and Florida ofﬁcials collected samples for laboratory analysis but were unable to isolate the S. typhi bacterium. FDA’s southeast regional laboratory in Atlanta did, however, ﬁnd high concentrations of both fecal coliform and E. coli bacteria in the samples, signs that the products had heavy bacterial contamination and possibly harbored the typhoid bacteria. In late February, FDA ofﬁcials inspected a frozen mamey production plant in Guatemala that health ofﬁcials there had closed down weeks earlier because of the outbreak. ‘‘Even though we got there after the facility was closed,’’ says Chappell, ‘‘it was obvious that the product was produced under [substandard] sanitation conditions.’’ Also, the contamination could have occurred as a result of Hurricane Mitch, which hit Guatemala hard in late 1998, possibly polluting the water supply used to make the fruit product. On March 8, FDA announced the voluntary recall of El Sembrador frozen mamey, along with two other brands also suspected of being contaminated: La Fe and a product with no brand name produced by Agrodex in Guatemala. At press time, these products were awaiting destruction. Other brands of frozen mamey not associated with the outbreak are still available. C.

‘‘Juice Maker Fined Record Amount for E. Coli –Tainted Product’’

The May–June 1997 issue of FDA Consumer magazine carried the above-headlined article on legal action against E. coli contaminated fruit (by John Henkel). A California juice company was ﬁned $1.5 million after pleading guilty to 16 misdemeanor criminal charges related to a 1996 outbreak of dangerous Escherichia coli O157:H7 bacteria. One child died and 14 other children were seriously sickened after drinking the company’s fresh, unpasteurized apple juice. The ﬁne is one of the largest ever imposed in FDA history for a food injury case, and the criminal conviction by federal prosecutors is one of the ﬁrst ever obtained in a large-scale outbreak of infectious pathogens. Odwalla Inc., of Half Moon Bay, agreed in a criminal plea bargain in July to pay the ﬁne and serve 5 years of court-supervised probation. The plea agreement, ﬁled in U.S. District Court for the Eastern District of California, also requires Odwalla to implement a Hazard Analysis and Critical Point (HACCP) plan in its facility. A HACCP plan is a food safety system that identiﬁes potential food safety hazards and speciﬁes controls for preventing these hazards. A $250,000 portion of the ﬁne will be divided between a charitable organization, © 2003 by Marcel Dekker, Inc.

Safe Tables Our Priority (STOP), and the food safety research centers of the University of Maryland and Pennsylvania State University. The funds will be used to raise consumer food safety awareness and research the safety of fresh produce. The tainted juice affected consumers in Colorado, California, Washington State, and British Columbia. Fifteen children who drank the juice developed the life-threatening condition hemolytic uremic syndrome (HUS), a leading cause of kidney failure in children. One of the children, a 16-month-old Colorado girl, died from HUS-related multiple organ failure. At least 51 others were sickened but to a lesser degree. Food safety experts say survivors of this strain of E. coli may have signiﬁcant health problems for years. In late October 1996, FDA received word that the health departments from the three affected states had identiﬁed an E. coli O157:H7 outbreak. Washington State health ofﬁcials also told FDA that using DNA ﬁngerprinting methods, they had clustered 15 related cases of E. coli infection in which all the victims had reported drinking Odwalla apple juice. When notiﬁed of these ﬁndings, Odwalla began a recall on October 31 of all its apple juice products. At the same time, FDA launched a 14-month investigation. An investigator with FDA’s San Francisco district ofﬁce, Helen Hamaoka, inspected the Odwalla plant and collected apple juice samples, which were shipped to FDA’s analytical laboratory in Seattle. Tests showed the samples were negative for E. coli O157:H7. Hamaoka noted, however, that the company had ignored safety standards by centering its product testing more on shelf-life than bacterial contamination. On November 5, 1996, FDA’s Seattle district laboratory analyzed samples of juice found in an Odwalla warehouse in Washington State. One sample that came from juice processed around October 7, 1996, tested positive for E. coli O157:H7. The laboratory analysis enabled FDA to link the E. coli outbreak to Odwalla juice. As part of its criminal investigation of Odwalla, FDA’s Ofﬁce of Criminal Investigations (OCI) began interviewing former Odwalla employees, suppliers, and others familiar with company operations. Their comments indicated that Odwalla had in the past had numerous deﬁciencies in its sanitation procedures. For example, accepted industry practice calls for use of a chlorine solution for washing and sanitizing fruit, but Odwalla had stopped using chlorine and was instead using phosphoric acid, which may not be effective as a fruit wash. The OCI also learned that the U.S. Army had rejected a contract with Odwalla in June 1996 after Army analysis identiﬁed a high bacterial count in an Odwalla product. The OCI also discovered that a consultant hired by the company had uncovered Listeria and other bacterial contamination in the processing plant during weekly microbiological tests he conducted between May 1994 and December 1995. The OCI learned that Odwalla initially tried to identify and eliminate the source of the Listeria contamination but ultimately focused on extending shelf-life without ever conclusively solving the contamination problem. Records showed that Odwalla had used an inferior grade of apples, which may have made the juice more prone to contamination. After determining that Odwalla’s operations created an environment within which E. coli O157:H7 could exist, OCI’s investigation centered on determining the source of the contamination. Though ofﬁcials could not pinpoint the exact source, several theories emerged. Among them are The apples used to make the juice were contaminated with animal fecal material. The wooden crates used to ship the apples were contaminated. © 2003 by Marcel Dekker, Inc.

Odwalla employees failed to wash their hands properly after using the bathroom and before returning to production areas. As part of the consent decree, Odwalla implemented a HACCP plan whose provisions included 1. 2. 3.

Maintaining sanitary conditions to avoid food contamination A written sanitation control program run by a qualiﬁed manager A comprehensive employee training program in areas such as proper food handling and personal hygiene.

In June 1997, Hamaoka inspected Odwalla again and took juice samples and swabs from the company’s equipment for analysis. The samples proved negative for E. coli, and Hamaoka noted that the company had begun using more effective sanitation methods. The FDA will continue to inspect Odwalla regularly to ensure HACCP compliance. D.

‘‘Sandwich Maker Fined for Consent Decree Violation’’

The May–June 1997 issue of FDA Consumer magazine carried the above-headlined article by John Henkel on legal action against a sandwich maker for sanitation violation. A breach in a court-ordered consent decree by a New Orleans food company has resulted in a $2500 ﬁne against the company. Finest Foods Inc., maker of Mrs. Drake’s Sandwiches, violated the decree when it resumed operations without FDA permission after being closed by the agency for unsanitary conditions. The 1993 consent decree requires Finest Foods to get FDA’s approval before resuming operations. Finest Foods, which makes about 11,000 sandwiches a day for retail sale, signed the consent decree in the U.S. District Court for the Eastern District of Louisiana after FDA found recurring problems. A 1994 amendment to the consent decree allows FDA to shut down Finest Foods’s sandwich operation if the company violates the decree provisions. The FDA found such violations in February 1996 when investigators inspected the facility and found L. monocytogenes contamination and other conditions, such as ﬁlth in the processing plant and unsanitary food handling procedures. Listeria monocytogenes can be fatal to infants, older adults, and people with weakened immune systems. The conditions FDA found were similar to those that led to the 1993 consent decree. Following the February inspection, FDA sent a letter saying the plant must cease operations until the violations are corrected. Under the consent decree, if FDA orders the facility to shut down, the company, with written documentation of corrections, can request reconsideration and stay open until FDA conﬁrms that the shutdown is necessary. On April 23, 1996, FDA delivered another letter to Finest Foods saying the company had failed to address its deﬁciencies and that it should suspend its operations immediately. That day the company met with FDA and agreed to the ordered suspension. The FDA told the company that to reopen it must 1. 2. 3.

Shut down and clean the plant and equipment. Hire an independent expert to ensure that the company makes the required corrections and to provide FDA with a written statement certifying compliance. Test the plant and products for contamination.

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According to court records, the company said it fulﬁlled all three requirements on April 24, the day after the shutdown. But FDA learned that the company reopened the facility before receiving test results, without providing a written statement from the expert, and without getting FDA’s permission. On April 30, FDA told the company it had violated the consent decree by reopening. Finest Foods again suspended operations until May 2, when FDA inspected the facility and allowed the company to reopen. FDA took the consent decree breach to district court, where on December 18 Judge Peter Beer found that the company’s actions were a ‘‘willful violation’’ of the decree. In ordering the $2500 ﬁne, Beer cited only the company for contempt, not the individual defendants, company owners James and Timothy Ganus. He found that their actions ‘‘were mitigated by their overall efforts to comply with the consent decree.’’ Finest Foods has since resumed operation and, FDA ofﬁcials say, the company has taken measures to stay in compliance with the consent decree. ACKNOWLEDGMENT Most data provided in this chapter have been obtained from documents prepared by Science Technology System, West Sacramento, CA. Permission to use the materials has been granted by Science Technology System.

© 2003 by Marcel Dekker, Inc.

36 A Review of U.S. Food Safety Policies and Programs Tin Shing Chao U.S. Department of Labor, Honolulu, Hawaii, U.S.A.

I.

INTRODUCTION

All previous chapters have introduced you to the laws, regulations, and practices concerning sanitation, safety, and other aspects of the operations of an establishment to produce a safe and wholesome food. This chapter summarizes the government policies and programs that make it possible to have a safe food supply. The production of the nation’s food supply has long been an important part of the U.S. Food and Drug Administration’s (FDA) public health mission. Throughout the years, the U.S. government has established different food regulations and employed food inspectors to enforce its laws. As we are entering the 21st century, new technology has emerged, and there are always new ways in manufacturing and producing food supplies. For the consumer, the challenges facing the food safety system are constantly changing as technology changes. Foodborne illness in the United States is a major cause of personal distress, preventable death, and avoidable economic burden. In 1994, the Council for Agriculture Science and Technology estimated 33 million people become ill from microorganism in food, resulting in as many as 9,000 needless deaths every year. For many victims, foodborne illness results only in discomfort or lost time from job. For some, especially preschool age children, older adults in health care facilities, and those with impaired immune systems, foodborne illness is more serious and may be life threatening. The Centers for Disease Control and Prevention has consistently stated that where reported foodborne illness outbreaks were caused by mishandling of food, most of the time the mishandling occurs within the retail segment of the food industry (restaurants, © 2003 by Marcel Dekker, Inc.

markets, schools, churches, camps, institutions, and vending locations), where ready-toeat food is prepared and provided to the public for consumption [1].

II. OVERVIEW OF FEDERAL LAWS AND REQUIREMENTS Those who are responsible for food processing of any kind in the United States are all subject to some rather complicated laws, many of which can sometimes be contradictory on some points, but in general they all have similar objectives. In general, an overview of the agencies and laws pertaining to food processing is as follows: A.

Food and Drug Administration

The Food, Drug, and Cosmetic Act provides guidelines for the food processors how to deal with (1) adulteration of foods; (2) unsanitary conditions in plants; and (3) good manufacturing practices. In addition, defect action levels deal with rodent droppings and insect parts in speciﬁc raw materials. B.

Environmental Protection Agency

The Federal Insecticides, Fungicide, and Rodenticide Act (FIFRA) covers the use of insecticides, rodenticides, and sanitizing solutions used by everyone in the nation, not merely food processors. C.

United States Department of Agriculture

This agency executes the laws applied to food processors that offer products containing meat and poultry. Food processors such as bakers who use eggs in their ﬁnished products are not covered by these rules. D.

Hazard Analysis and Critical Control Points System

At present, FDA has introduced regulation to implement an industry-wide system called the hazard analysis and critical control point (HACCP) plan for seafood processing and fruit and vegetable juices. The U.S. Department of Agriculture (USDA) is implementing HACCP plans for some aspects of meat and poultry processing. It is expected that over the next decade or so, most categories of food manufacturing will be covered by the HACCP program. E.

State and Local Regulations

State and local governments usually have their speciﬁc laws pertaining to food processing, storage, and sale. These laws generally go hand in hand with the Food, Drug, and Cosmetic Act and the good manufacturing practices. In many states, some of these laws are more speciﬁc and stringent. Many states are under contract with the Food and Drug Administration to conduct FDA regulatory inspections of food processors in their areas. Roving FDA teams often follow, on a random basis, inspections performed by state inspectors. © 2003 by Marcel Dekker, Inc.

F.

Military Standards

Food processors who produce products for military installations including commissaries can expect inspections by the military once every 6 months. Military standards are very similar to good manufacturing practices, but certain speciﬁcs are included. If you are a food processor dealing with the military, make certain you have a copy of these laws. Regardless of the agency or agencies, these laws are all designed to eliminate the possibility of foodborne illness and or personal injury that comes about from the pathogenic microbes or their toxins, pests and pest evidences, and foreign materials. III. HISTORY OF FOOD CODES Previous editions of food codes recommended by the United States Public Health Services for regulating operations for providing food directly to the consumer [2] are summarized as follows: 1934: Restaurant Sanitation Regulations. Proposed by the U.S. Public Health Service (PHS) in cooperation with the Conference of State and Territorial Health Ofﬁcers and the National Restaurant Code Authority. 1935: An Ordinance Regulating Food and Drink Establishment. Recommended by U.S. Public Health Service, December 1935 (Mimeographed). 1938: Ordinance and Code Regulating Eating and Drinking Establishment. Recommended by the U.S. Public Health Service, March 1938 (Mimeographed). 1940: Ordinance and Code Regulating Eating and Drinking Establishments. Recommended by the U.S. Public Health Service, June 1940 (Mimeographed). 1943: Ordinance and Code Regulating Eating and Drinking Establishments. Recommended by the U.S. Public Health Service. FSA/Public Health Bulletin No. 280 (republished in 1955 as DHEW/PHS Publication No. 37). 1957: The Vending of Foods and Beverages—A Sanitation Ordinance and Code. Recommendations of the Public Health Service. DHEW/PHS Publication No. 546. 1962: Food Service Sanitation Manual Including a Model Food Service Sanitation Ordinance and Code. Recommendations of the Public Health Service. DHEW/PHS Publication No. 934. 1965: The Vending of Food and Beverages—A Sanitation Ordinance and Code. Recommendations of the Public Health Service. DHEW/PHS Publication 1965, No. 546. 1976: Food Service Sanitation Manual Including a Model Food Service Sanitation Ordinance. Recommendations of the Food and Drug Administration (DHEW/PHS/FDA). DHEW Publication No. (FDA) 78-2091. 1978: The Vending of Food and Beverages Including a Model Sanitation Ordinance. Recommendations of the Food and Drug Administration (DHEW/PHS/ FDA). DHEW Publication No. (FDA) 78-2091. 1982: Retail Food Store Sanitation Code. Recommendations of the Association of Food and Drug Ofﬁcals and U.S. Department of Health and Human Services/ Public Health Service/Food and Drug Administration. 1993: Food Code. Recommendations of the U.S. Public Health Service, Food and © 2003 by Marcel Dekker, Inc.

Drug Administration. National Technical Information Service Publication PB94113941. 1995: Food Code. Recommendations of the U.S. Public Health Service, Food and Drug Administration. National Technical Information Service Publication PB95265492. 1997: Food Code. Recommendations of the U.S. Public Health Service, Food and Drug Administration. National Technical Information Service Publication PB97133656. 1999: Food Code. Recommendations of the U.S. Public Health Services, Food and Drug Administration. National Technical Information Services Publication PB-99-115925. 2001: Food Code. Recommendations of the U.S. Public Health Services, Food and Drug Administration. National Technical Information Services Publication PB-2002100819. The 2001 Food Code is the most current; numerous editing changes were made throughout the document for internal consistency. The 2001 Food code incorporated corrections and clariﬁcation to the 1999 Food Code. To view the summary of changes for the 2001 Food Code see the following web site: http://cfsan.fda.gov/⬃dms/fc01-sum.html. IV. PUBLIC HEALTH AND CONSUMER EXPECTATIONS It is a shared responsibility of the food industry and the government to ensure that food provided to the consumer is safe and does not become a vehicle in a disease outbreak or in the transmission of communicable disease. This shared responsibility extends to ensuring that consumer expectations are met and that food is unadulterated, prepared in a clean environment, and honestly presented. Under FDA’s 1997 mission statement the agency is responsible for ensuring that foods are safe, wholesome, and sanitary; regulated products are honestly, accurately, and informatively represented; these products are in compliance with the law and FDA regulations; noncompliance is identiﬁed and corrected; and any unsafe or unlawful products are removed from the market place [3]. V.

NATIONAL FOOD SAFETY INITIATIVES

To protect consumers from foodborne disease, the United States must strengthen the nation’s capacity to predict and prevent foodborne hazards and to monitor and rapidly react to outbreaks of foodborne diseases. To achieve the public health goal of reducing foodborne illness to the fullest extent possible, steps must be taken at each point in the farmto-table chain where hazards can occur. Important progress has been made in the efforts to monitor and prevent foodborne disease and ensure that consumers are provided with the safest possible foods. These activities encompass the entire continuum of food production, food processing and manufacture, retail food stores, and food services to consumers. Former President Clinton’s National Food Safety Initiative recommended the adoption and implementation of the Food Code that, corresponding with congressional appropriations, authorized the following initiatives: 1.

A provision to ensure the safety of domestic and imported fresh fruits and vegetables

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2. The creation of the Foodborne Outbreak Response Coordination Group (FORCG) to improve federal and state agencies’ response to foodborne disease outbreaks 3. The initiation of PulseNet, a public health laboratory network that ‘‘ﬁngerprints’’ bacteria and permits more rapid and accurate detection of foodborne illness outbreaks 4. The expansion of FoodNet, the collaboration Foodborne Disease and Active Surveillance Network, which measures the burden and sources of foodborne disease in the United States 5. The establishment of the Joint Institute for Food Safety Research to coordinate food safety research and priority setting 6. The formation of the President’s Council on Food Safety that will develop a strategic plan for federal food safety activities and recommend ways to enhance coordination and improve effectiveness in the food safety system. The FDA, USDA-Food Safety and Inspection Service (FSIS), and Centers for Disease Control (CDC) endorse the Food Code because the code provides public health and regulatory agencies with practical science-based advice and manageable, enforceable provisions for mitigating risk factors known to contribute to foodborne disease [4]. VI. REGULATORY PROGRAMS The FDA’s Ofﬁce of Regulatory Affairs (ORA) mission statement is ‘‘Achieve effective and efﬁcient compliance products through high quality, science-based work that results in maximizing consumer protection.’’ The ORA is responsible that FDA-regulated products (food, drugs, medical devices, cosmetics, radiation-emitting products such as microwave ovens, and feed and drugs for pets and farm animals) comply with the consumer protection laws and regulations and agency enforcement. Approximately 900 investigators and 100 compliance ofﬁcers in FDA ofﬁces around the United States are assigned to the Ofﬁce of Regulatory Affairs. Dennis Baker, the associate commissioner for regulatory affairs, said in the FY 1999 annual report: FDA inspects all food (except meat and poultry products) of domsestic and foreign origin either directly or through contracts with state agencies. We want to make sure the food is wholesome and not misbranded. That responsibility includes food production, processing, distribution and sale at the retail level. We also investigate issues related to drug residues and pesticides in the food supply We provide training to state health and agriculture ofﬁcial and work for passage of the Food Code. We are targeting inspections to identify those products that have the highest level of contaminants and the highest level of food safety concern, such as low-acid canned foods or sanitation in the seafood, fruit and vegetable juices industry.

VII. FOOD SAFETY INITIATIVE PROGRESS AND PERSPECTIVE Dr. Robert Buchanan, senior science advisor to the Center for Food Safety and Applied Nutrition (CFSAN), shared his thoughts about advances in food science research and where science will lead us into the next century. The following is an excerpt from his report: © 2003 by Marcel Dekker, Inc.

In 1906 with the passage of the Pure Food and Drug Act, the government was able to gain control over the economic adulteration of food and inappropriate use of chemicals. From there, the entire discipline of food science developed to the point today where there is a system in place that identiﬁes risks in foods. We have moved from a system that began as ‘‘buyer beware’’ to HACCP—hazard analysis critical control points, which is based on the producer anticipating hazards and preventing them. There is now a safety net under the entire food system. Microbiology was a new science at the turn of the century. Chemistry and toxicology had not been around too long. Here is a good example of progress we are making: During the last 25 years the standard technique for isolating low acid level of Listeria in food took one month. Now, gene-based system can identify Listeria in six hours. This has helped reduce by 60% the incidence of listeriosis in the last 10 years.

Nothing in the food industry stays the same. Food changes, the marketplace changes, and the demographics of the population changes. This results in new challenges in new food safety problems. Science will provide us with an ability to anticipate and rapidly respond to threats to public health. The translation of knowledge we’ve gained in the last 10 years will turn into practical solutions in the next 10 years. For example, in the 1990s it became apparent that foodborne pathogens start on the farm. It is now the job of science to identify those pathogens and identify methods for reducing or eliminating them. Not all research is conducted in a laboratory. As part of the President’s Food Safety Initiative, FDA and USDA’s National Agriculture Services were directed to work together to establish a baseline description of current agriculture practices used in the production of fresh fruits and vegetables in the United States, and to conduct a survey every two years to measure changes in agriculture practices [5]. VIII. THE JOINT INSTITUTE FOR FOOD SAFETY RESEARCH On July 3, 1998, President Clinton directed the Department of Health and Human Services (DHHS) and the U.S. Department of Agriculture to develop a plan to create the Joint Institute for Food Safety Research ( JIFSR). The goal of JIFSR is to (1) coordinate planning and priority setting for food safety research among the two departments, other government agencies, and the private sector and (2) foster effective translation of research results into practices along the farm-to-table continuum [6]. IX. SURVEILLANCE AND OUTBREAK RESPONSE Detecting and responding to emerging pathogens in food supply quickly and effectively is essential to preventing widespread illness. PulseNet—a collaborative project between CDC, FDA, USDA, and state health departments—uses dedicated, high-speed Internet connections for the rapid comparison of DNA ﬁngerprints of foodborne bacteria with those in an ever-growing database at CDC. When the system detects a match between ﬁngerprints of bacteria isolated from different areas, an automated e-mail massage is sent to all the participants alerting them of a possible multistate outbreak. Dr. Farukh M. Khambaty, the microbiologist in charge of PulseNet at CFSAN, stated [7]: Using the method of pulsed-ﬁeld gel electrophoresis (PFGE) to general DNA ﬁngerprints of bacteria has proved to be the most reproducible and discriminatory solution for linking sporadic cases of foodborne illness with larger foodborne outbreaks. With the advances in the

© 2003 by Marcel Dekker, Inc.

speed of computers and the development of the Internet, we can rapidly analyze and transfer huge ﬁles of information.

In 1999, an important case stands out as illustrative of the beneﬁts of PulseNet. PulseNet proved useful in linking cases of shigella infections in Minnesota, Massachusetts, California, and Canada to fresh parsely from a single operation in Mexico. In 1999, PulseNet capability was expended to FDA labs in Los Angeles; Brooklyn, NY; Atlanta; Denver; Seattle; and Jefferson, AK [7].

X.

THE NATIONAL FOOD SAFETY SYSTEM PROJECT

The FDA is leading an effort to improve coordination and communication among public health and food regulatory ofﬁcials, particularly around foodborne illness outbreaks. This effort, known as the National Food Safety System (NFSS) project, contributes signiﬁcantly to more effective implementation of existing food safety programs. Work began in September 1998 with an FDA-hosted meeting of food safety and agriculture ofﬁcials from all 50 states, Puerto Rico, and the District of Columbia; epidemiologist and laboratory staff from state and local health departments; and colleagues from CDC, USDA, and EPA. Discussions from that meeting led to the creation, in 1999, of a nationwide coordinating commitee and workgroups to generate ideas for activities that would promote an integrated national food safety system. Workgroups were established in six areas: role and responsibilities; outbreak coordination and investigations; laboratory operations and coordination; national uniform criteria; information sharing and data collection; and communication. In 1999, two laboratory accreditation training programs were held. The ﬁrst, in March of 1999, was for workgroup members. The second, in June of 1999, was held in conjunction with the Association of Food and Drug Ofﬁcials (AFDO) and preceded AFDO’s annual meeting. Over 70 federal, state, university, and private laboratory personnel attended the workshop. The outbreak coordination and investigations workgroup made progress in 1999; a draft outline of a guidelines manual for coordinating foodborne outbreak and traceback investigation was completed. One course focused on conducting a traceback investigation using the procedures outlined in the ‘‘FDA Guide to Traceback Fruits and Vegetables Implicated in Epidemiological Investigations.’’ The training also covered the decisionmaking process for initiating tracebacks and the roles of producers, distributors, importers, and investigators and how they ﬁt into the overall traceback investigation. A foodborne illness course provided an opportunity to learn how to develop and maintain a surveillance system and how to apply epidemiological principles to an investigation [8].

XI. NATIONAL ANTIMICROBIAL RESISTANCE MONITORING SYSTEM The United States now has in place a system that allows FDA to tell when foodborne bacteria that cause disease in humans begin to develop resistance to antimicrobials used in food animals. The system is called National Antimicrobial Resistance Monitoring System Enteric Bacteria (NARMSEB). It combines the resources of FDA, CDC, and USDA to create a nationalwide monitoring system. © 2003 by Marcel Dekker, Inc.

Informed public health ofﬁcials, responsible animal producers, drug manufacturers, and veterinarians can use this information to control and prevent harm from the use of antimicrobials in food animals through prudent antibiotic use practices. The system tests the susceptibility of gram-negative bacteria for susceptibility to 17 different antibiotics and the susceptibility of gram-positive Enterococci to 27 antibiotics. The human isolates are tested by CDC, and the animal isolates by the Agriculture Research Services of USDA. The FDA initiated the program in 1996 and signiﬁcantly expanded it under the Food Safety Initiative in 1999 to collect more isolates from more locations and more types of bacteria from animals and humans [9]. XII. FDA-FUNDED STATE FOOD SAFETY TASK FORCES Working to improve coordination among state and local regulatory, industry, legislative, and consumer organizations, FDA funded the establishment of 23 food safety task forces. Richard Barnes, Director of Federal–States Relations in FDA’s Ofﬁce of Regulatory Affairs stated ‘‘The goal of funding the 23 state food safety task forces is to create a better food safety system from local level all the way up to the state level’’ [10]. XIII. MAKING PROGRESS TOWARD A SAFER FOOD SUPPLY While the American food supply is among the safest in the world, we can always do more. We are eating a greater variety of foods thoughout the year from all over the country and all around the world. Statistics have shown we are eating more and more food prepared outside our homes. Nearly a quarter of our population is considered at-risk for developing foodborne illness. Research has shown there are more than ﬁve times the number of foodborne pathogens in 1999 than there were 50 years ago. The most critical element of our nation’s food safety system is a strong science base to underpin decisionmaking from research and risk assessment to surveillance, inspection, training, and education. Susan Alpert, Director of Food Safety for the Center for Food Safety and Applied Nutrition stated ‘‘Bacteria are smarter than people. We will never totally eliminate them from food supply. Where we can reasonably improve food safety by decreasing bacterial contamination we should. The challenge is to evaluate the entire farm-to-table process and ﬁnd the places where we can take steps to decrease pathogens. I expect to see accomplishment in the areas of technology, science, risk assessment, and education.’’ XIV.

OPERATIONAL AND ADMINISTRATIVE SYSTEM FOR IMPORT SUPPORT

The Operational and Administrative System for Import Support (OASIS) is a national computer database on imports, enforcement activities, and ﬁndings. This system not only supports FDA ﬁeld personnel in carrying out their day-to-day activities, but also provides headquarters personnel and program staff within the FDA centers with vital information on FDA compliance program and enforcement accomplishments. FDA uses OASIS to decide the admissibility and to ensure the safety, efﬁcacy, and quality of the foreign products for which the FDA has regulatory responsibility under the Federal Food, Drug, and Cosmetic Act. According to FDA the OASIS computer system enables them to handle the burgeoning volume of shipments of imported products more efﬁciently and more effectively, despite the decreasing agency resources [12]. © 2003 by Marcel Dekker, Inc.

According to another report provided by FDA the OASIS system has signiﬁcantly sped up processing time compared to the manual system used previously. OASIS routes admissibility decisions electronically to the computer of the importer’s agents within minutes when the importer electronically transmits shipment data to FDA. Therefore, 85% of the shipments are cleared without submission of paper by the importers [13]. Automated screening functions enhance FDA’s ability to detect problems, thereby helping to keep violative goods from entering the country. When OASIS identiﬁes there is a problem with certain imported goods, FDA’s district ofﬁce will issue a ‘‘Notice of Detention and Hearing’’ to the owner or the consignee. In the import detention report (IDR) it speciﬁes the nature of the violation to the owner or consignee. The owner is entitled to an informal hearing to provide testimony regarding the admissibility of the product. Each month, FDA will post the IDR on the FDA web site. People can view IDR report either by country or by product and view the violation charge code at the following site: http://www.fda.gov/ora/oasis. By having national data on imports, enforcement activities, and ﬁndings, FDA management is better able to spot emerging trends, identify emergency situations, and alert all ﬁeld personnel quickly, allocate resources more effectively, and effect greater uniformity in enforcement activities throughout the country. XV. U.S. CUSTOMS AND SAFE FOOD IMPORTS American consumers enjoy one of the safest food supplies in the world. In enhancing the safety of the U.S. food supply, the Clinton administration funded the requests for food safety initiatives, the establishment of the Food Safety Council, and directives to improve the safety of the food supply [14]. On July 3, 1999, President Clinton expanded his safe food directive to the Secretary of Health and Human Services and the Secretary of the Treasury to take additional action to further protect consumers from unsafe imported foods. While most imported food is safe and most importers comply with U.S. food safety requirements, a few importers try to sidestep U.S. laws to bring unsafe or contaminated food into the country. While FDA is responsible for the safety of most imported foods, the U.S. Customs Services works hand in hand with FDA to [15] 1. Prevent distribution of imported unsafe food by means such as requiring food to be held until reviewed by FDA 2. Destroying imported food that poses a serious public health threat 3. Prohibiting the reimportation of food that has been previously refused admission and has not been brought into compliance with U.S. laws and regulations, and requiring the marking of shipping containers and/or papers of imported food that is refused admission for safety reasons 4. Setting standards for private laboratories for the collection and analysis of samples of imported food for the purpose of gaining entry into the United States 5. Increasing the amount of the bond posted for imported foods when necessary to deter premature and illegal entry into the United States 6. Enhancing enforcement against violations of U.S. laws related to the importation of foods, including through the imposition of civil monetary penalties. Many of the mentioned activities represent signiﬁcant changes in the FDA import program. FDA and customs have conducted a series of public meetings to present and discuss those activities to both the industry and the public before implementing changes in these six © 2003 by Marcel Dekker, Inc.

areas. One could ﬁnd the ﬁnal rules on the appropriate agency’s internet website. The development and implementation of the planned activity in the six areas will increase the tools available to FDA and customs to protect American consumers from unsafe imported foods. FDA and customs will use these tools to focus on problem importers who try to sidestep U.S. laws to bring unsafe or contaminated food into the country. FDA and customs anticipate continuation of working together in cooperation with the U.S. Department of Agriculture, Environmental Protection Agency, Food Safety Inspection Service, Animal and Plant Health Inspection Service, Foreign Agriculture Service, U.S. trade representatives, and the Food Safety Council to protect consumers from unsafe imported food [16]. XVI.

SAFE TRANSPORTATION OF FOODS

The American food system provides consumers with an abundant supply of convenient, economical, high-quality, and safe food products. This system is built on the enterprise and innovative capacities of those who produce and market food in the United States, and it is driven by the high expectations of American consumers for the foods they purchase for their families. The Secretary of Transportation introduced the Sanitary Food Tranportation Act of 1990, which prohibits certain food transportation practices. It also safeguards food and certain other products from contamination during motor or rail transportation [17]. Food being transported in interstate commerce is subjected to federal and state regulations. Customs also plays an important role in safeguarding and prohibiting contaminated food items from entering the United States. Customs also works in conjunction with FDA, USDA, EPA, etc., to regulate domestic food as well. If an imported food is suspected, it can be tested for contamination and its entry into the United States can be denied. Food safety is an important public health issue. The Sanitary Food Transportation Act of 1990 only covers a limited area in food transportation. Former president Clinton’s administration developed and implemented some major steps toward reinventing food regulations after the Vice President’s National Performance Review in 1993, and as a result a blueprint for reinventing our nation’s food safety system was issued [18]. Other U.S food safety initiatives and inspection programs, such as USDA’s Food Safety Inspection Service, which oversees importation of food from foreign countries ensure that imported food meets U.S. regulations. FDA also issued regulations that require the meat, poultry, and seafood industries to follow hazard analysis and critical control point plans. This HACCP standards calls for food industries to implement measures at each critical control point. The industries are also responsible for controlling their own safety assurance actions. The HACCP standards bring regulation of meat, poultry, and seafood in line with state-of-the-art scientiﬁc procedures [19]. These regulations also help regulate food safety during transportation as part of the critical control point. From farm to table is a long journey; Food items pass through a lot of hands before reaching consumers. It is not easy to accomplish this task; many different trades and the government have to work hand in hand in order to achieve the delivery of safe food to our table. The combined efforts of domestic and international food importers working with different government agencies will ensure that safe and wholesome food can reach consumers’ tables. XVII.

CONCLUSION

In conclusion, a quote from then President Clinton’s December 11, 1999, radio address: ‘‘Food Safety is part of our citizens’ basic contract with the government.’’ The FDA together with other agencies are working hard to achieve and maintain this goal [11]. © 2003 by Marcel Dekker, Inc.

REFERENCES 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19.

www.fda.gov www.fda.gov www.fda.gov www.fda.gov www.fda.gov www.fda.gov www.fda.gov www.fda.gov www.fda.gov www.fda.gov www.fda.gov www.fda.gov www.fda.gov www.customs.ustreas.gov www.customs.ustreas.gov www.customs.ustreas.gov www.fda.gov www.fda.gov www.fda.gov

© 2003 by Marcel Dekker, Inc.

APPENDIX A U.S. Food and Drug Administration Good Manufacturing Practices U.S. Code of Federal Regulations

The following is excerpted from 21 CFR 110, last revised April 1, 2001.

TITLE 21—FOOD AND DRUGS

PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING

Subpart A—General Provisions

Sec. 110.3 Deﬁnitions. The deﬁnitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) are applicable to such terms when used in this part. The following deﬁnitions shall also apply: (a) Acid foods or acidiﬁed foods means foods that have an equilibrium pH of 4.6 or below. (b) Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice. (c) Batter means a semiﬂuid substance, usually composed of ﬂour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods. © 2003 by Marcel Dekker, Inc.

(d) Blanching, except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for a sufﬁcient time and at a sufﬁcient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food. (e) Critical control point means a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to ﬁlth in the ﬁnal food or decomposition of the ﬁnal food. (f) Food means food as deﬁned in section 201(f) of the act and includes raw materials and ingredients. (g) Food-contact surfaces are those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. ‘‘Food-contact surfaces’’ includes utensils and food-contact surfaces of equipment. (h) Lot means the food produced during a period of time indicated by a speciﬁc code. (i) Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health signiﬁcance. The term ‘‘undesirable microorganisms’’ includes those microorganisms that are of public health signiﬁcance, that subject food to decomposition, that indicate that food is contaminated with ﬁlth, or that otherwise may cause food to be adulterated within the meaning of the act. Occasionally in these regulations, FDA used the adjective ‘‘microbial’’ instead of using an adjectival phrase containing the word microorganism. ( j) Pest refers to any objectionable animals or insects including, but not limited to, birds, rodents, ﬂies, and larvae. (k) Plant means the building or facility or parts thereof used for or in connection with the manufacturing, packaging, labeling, or holding of human food. (1) Quality control operation means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of the act. (m) Rework means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food. (n) Safe-moisture level is a level of moisture low enough to prevent the growth of undesirable microorganisms in the ﬁnished product under the intended conditions of manufacturing, storage, and distribution. The maximum safe moisture level for a food is based on its water activity, a w . An a w will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given a w will not support the growth of undesirable microorganisms. (o) Sanitize means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health signiﬁcance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. (p) Shall is used to state mandatory requirements. (q) Should is used to state recommended or advisory procedures or identify recommended equipment. (r) Water activity (a w ) is a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. © 2003 by Marcel Dekker, Inc.

Sec. 110.5 Current good manufacturing practice. (a) The criteria and deﬁnitions in this part shall apply in determining whether a food is adulterated (1) within the meaning of section 402(a)(3) of the act in that the food has been manufactured under such conditions that it is unﬁt for food or (2) within the meaning of section 402(a)(4) of the act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with ﬁlth, or whereby it may have been rendered injurious to health. The criteria and deﬁnitions in this part also apply in determining whether a food is in violation of section 361 of the Public Health Service Act (42 U.S.C. 264). (b) Food covered by speciﬁc current good manufacturing practice regulations also is subject to the requirements of those regulations. Sec. 110.10

Personnel.

The plant management shall take all reasonable measures and precautions to ensure the following: (a) Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors. (b) Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to: (1) Wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials. (2) Maintaining adequate personal cleanliness. (3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. (4) Removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials. (5) Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material. (6) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints. (7) Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed. © 2003 by Marcel Dekker, Inc.

(8) Conﬁning the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco. (9) Taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin. (c) Education and training. Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices. (d) Supervision. Responsibility for assuring compliance by all personnel with all requirements of this part shall be clearly assigned to competent supervisory personnel.

Sec. 110.19 Exclusions. (a) The following operations are not subject to this part: Establishments engaged solely in the harvesting, storage, or distribution of one or more ‘‘raw agricultural commodities,’’ as deﬁned in section 201(r) of the act, which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public. (b) FDA, however, will issue special regulations if it is necessary to cover these excluded operations.

Subpart B—Buildings and Facilities

Sec. 110.20 Plant and grounds. (a) Grounds. The grounds about a food plant under the control of the operator shall be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds include, but are not limited to: (1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests. (2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed. (3) Adequately draining areas that may contribute contamination to food by seepage, foot-borne ﬁlth, or providing a breeding place for pests. (4) Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed. If the plant grounds are bordered by grounds not under the operator’s control and not maintained in the manner described in paragraph (a) (1) through (3) of this section, © 2003 by Marcel Dekker, Inc.

care shall be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and ﬁlth that may be a source of food contamination. (b) Plant construction and design. Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes. The plant and facilities shall: (1) Provide sufﬁcient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food. (2) Permit the taking of proper precautions to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, ﬁlth, or other extraneous material. The potential for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: location, time, partition, air ﬂow, enclosed systems, or other effective means. (3) Permit the taking of proper precautions to protect food in outdoor bulk fermentation vessels by any effective means, including: (i) Using protective coverings. (ii) Controlling areas over and around the vessels to eliminate harborages for pests. (iii) Checking on a regular basis for pests and pest infestation. (iv) Skimming the fermentation vessels, as necessary. (4) Be constructed in such a manner that ﬂoors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from ﬁxtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact. (5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, ﬁxtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage. (6) Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces. (7) Provide, where necessary, adequate screening or other protection against pests. Sec. 110.35

Sanitary operations.

(a) General maintenance. Buildings, ﬁxtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufﬁcient to prevent food from becoming adulterated within the meaning of the act. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. © 2003 by Marcel Dekker, Inc.

(b) Substances used in cleaning and sanitizing; storage of toxic materials. (1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe and adequate under the conditions of use. Compliance with this requirement may be veriﬁed by any effective means including purchase of these substances under a supplier’s guarantee or certiﬁcation, or examination of these substances for contamination. Only the following toxic materials may be used or stored in a plant where food is processed or exposed: (i) Those required to maintain clean and sanitary conditions; (ii) Those necessary for use in laboratory testing procedures; (iii) Those necessary for plant and equipment maintenance and operation; and (iv) Those necessary for use in the plant’s operations. (2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identiﬁed, held, and stored in a manner that protects against contamination of food, foodcontact surfaces, or food-packaging materials. All relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of these products should be followed. (c) Pest control. No pests shall be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials. (d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. (1) Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use. (2) In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized as necessary. (3) Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food. (4) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and shall be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food-contact surfaces. (5) Sanitizing agents shall be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment. (e) Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and manner that protects food-contact surfaces from contamination. © 2003 by Marcel Dekker, Inc.

Sec. 110.37

Sanitary facilities and controls.

Each plant shall be equipped with adequate sanitary facilities and accommodations including, but not limited to: (a) Water supply. The water supply shall be sufﬁcient for the operations intended and shall be derived from an adequate source. Any water that contacts food or foodcontact surfaces shall be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities. (b) Plumbing. Plumbing shall be of adequate size and design and adequately installed and maintained to: (1) Carry sufﬁcient quantities of water to required locations throughout the plant. (2) Properly convey sewage and liquid disposable waste from the plant. (3) Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition. (4) Provide adequate ﬂoor drainage in all areas where ﬂoors are subject to ﬂoodingtype cleaning or where normal operations release or discharge water or other liquid waste on the ﬂoor. (5) Provide that there is not backﬂow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing. (c) Sewage disposal. Sewage disposal shall be made into an adequate sewerage system or disposed of through other adequate means. (d) Toilet facilities. Each plant shall provide its employees with adequate, readily accessible toilet facilities. Compliance with this requirement may be accomplished by: (1) Maintaining the facilities in a sanitary condition. (2) Keeping the facilities in good repair at all times. (3) Providing self-closing doors. (4) Providing doors that do not open into areas where food is exposed to airborne contamination, except where alternate means have been taken to protect against such contamination (such as double doors or positive air-ﬂow systems). (e) Hand-washing facilities. Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing: (1) Hand-washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands. (2) Effective hand-cleaning and sanitizing preparations. (3) Sanitary towel service or suitable drying devices. (4) Devices or ﬁxtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands. (5) Readily understandable signs directing employees handling unprotected food, unprotected food-packaging materials, of food-contact surfaces to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may have become soiled or contaminated. These signs may be posted in the processing room(s) and in all other areas where employees may handle such food, materials, or surfaces. © 2003 by Marcel Dekker, Inc.

(6) Refuse receptacles that are constructed and maintained in a manner that protects against contamination of food. (f) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces.

Subpart C—Equipment

Sec. 110.40 Equipment and utensils.

(a) All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. (b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms. (c) Equipment that is in the manufacturing or food-handling area and that does not come into contact with food shall be so constructed that it can be kept in a clean condition. (d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and construction that enables them to be maintained in an appropriate sanitary condition. (e) Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms shall be ﬁtted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment, and should be ﬁtted with an automatic control for regulating temperature or with an automatic alarm system to indicate a signiﬁcant temperature change in a manual operation. (f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food shall be accurate and adequately maintained, and adequate in number for their designated uses. (g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives. © 2003 by Marcel Dekker, Inc.

Subpart E—Production and Process Controls Sec. 110.80

Processes and controls.

All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source. Chemical, microbial, or extraneous material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. All food that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected or, if permissible, treated or processed to eliminate the contamination. (a) Raw materials and other ingredients. (1) Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food shall be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food. (2) Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act. Compliance with this requirement may be veriﬁed by any effective means, including purchasing raw materials and other ingredients under a supplier’s guarantee or certiﬁcation. (3) Raw materials and other ingredients susceptible to contamination with aﬂatoxin or other natural toxins shall comply with current Food and Drug Administration regulations, guidelines, and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into ﬁnished food. Compliance with this requirement may be accomplished by purchasing raw materials and other ingredients under a supplier’s guarantee or certiﬁcation, or may be veriﬁed by analyzing these materials and ingredients for aﬂatoxins and other natural toxins. (4) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall comply with applicable Food and Drug Administration regulations, guidelines, and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be veriﬁed by any effective means, including purchasing the materials under a supplier’s guarantee or certiﬁcation, or examination of these materials for contamination. (5) Raw materials, other ingredients, and rework shall be held in bulk, or in contain© 2003 by Marcel Dekker, Inc.

ers designed and constructed so as to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the act. Material scheduled for rework shall be identiﬁed as such. (6) Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the act. (7) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination. (b) Manufacturing operations. (1) Equipment and utensils and ﬁnished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning. (2) All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. One way to comply with this requirement is careful monitoring of physical factors such as time, temperature, humidity, a w , pH, pressure, ﬂow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidiﬁcation, and refrigeration to ensure that mechanical breakdowns, time delays, temperature ﬂuctuations, and other factors do not contribute to the decomposition or contamination of food. (3) Food that can support the rapid growth of undesirable microorganisms, particularly those of public health signiﬁcance, shall be held in a manner that prevents the food from becoming adulterated within the meaning of the act. Compliance with this requirement may be accomplished by any effective means, including: (i) Maintaining refrigerated foods at 45°F (7.2°C) or below as appropriate for the particular food involved. (ii) Maintaining frozen foods in a frozen state. (iii) Maintaining hot foods at 140°F (60°C) or above. (iv) Heat treating acid or acidiﬁed foods to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures. (4) Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH, or controlling a w that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health signiﬁcance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the act. (5) Work-in-process shall be handled in a manner that protects against contamination. (6) Effective measures shall be taken to protect ﬁnished food from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food. Food transported by conveyor shall be protected against contamination as necessary. (7) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination. (8) Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this requirement may be accomplished © 2003 by Marcel Dekker, Inc.

by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means. (9) Food, raw materials, and other ingredients that are adulterated within the meaning of the act shall be disposed of in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it shall be reconditioned using a method that has been proven to be effective or it shall be reexamined and found not to be adulterated within the meaning of the act before being incorporated into other food. (10) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step. (11) Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched food is washed prior to ﬁlling, water used shall be safe and of adequate sanitary quality. (12) Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. Compliance with this requirement may be accomplished by any effective means, including one or more of the following: (i) Using ingredients free of contamination. (ii) Employing adequate heat processes where applicable. (iii) Using adequate time and temperature controls. (iv) Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them. (v) Cooling to an adequate temperature during manufacturing. (vi) Disposing of batters at appropriate intervals to protect against the growth of microorganisms. (13) Filling, assembling, packaging, and other operations shall be performed in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any effective means, including: (i) Use of a quality control operation in which the critical control points are identiﬁed and controlled during manufacturing. (ii) Adequate cleaning and sanitizing of all food-contact surfaces and food containers. (iii) Using materials for food containers and food-packaging materials that are safe and suitable, as deﬁned in Sec. 130.3(d) of this chapter. (iv) Providing physical protection from contamination, particularly airborne contamination. (v) Using sanitary handling procedures. (14) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, © 2003 by Marcel Dekker, Inc.

and dehydrated food that relies on the control of a w for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices: (i) Monitoring the a w of food. (ii) Controlling the soluble solids/water ratio in ﬁnished food. (iii) Protecting ﬁnished food from moisture pickup, by use of a moisture barrier or by other means, so that the a w of the food does not increase to an unsafe level. (15) Food such as, but not limited to, acid and acidiﬁed food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices: (i) Monitoring the pH of raw materials, food in process, and ﬁnished food. (ii) Controlling the amount of acid or acidiﬁed food added to low-acid food. (16) When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part. (17) Food-manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food. Sec. 110.93 Warehousing and distribution. Storage and transportation of ﬁnished food shall be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container. Subpart G—Defect Action Levels Sec. 110.110 Natural or unavoidable defects in food for human use that present no health hazards. (a) Some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. The Food and Drug Administration establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action. (b) Defect action levels are established for foods whenever it is necessary and feasible to do so. These levels are subject to change upon the development of new technology or the availability of new information. (c) Compliance with defect action levels does not excuse violation of the requirement in section 402(a)(4) of the act that food not be prepared, packed, or held under unsanitary conditions or the requirements in this part that food manufacturers, distributors, and holders shall observe current good manufacturing practice. Evidence indicating that such a violation exists causes the food to be adulterated within the meaning of the act, © 2003 by Marcel Dekker, Inc.

even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, distributor, and holder of food shall at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible. (d) The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the ﬁnal food adulterated within the meaning of the act, regardless of the defect level of the ﬁnal food. (e) A compilation of the current defect action levels for natural or unavoidable defects in food for human use that present no health hazard may be obtained upon request from the Center for Food Safety and Applied Nutrition (HFS-565), Food and Drug Administration, 200 C St. SW, Washington, DC 20204.

© 2003 by Marcel Dekker, Inc.

APPENDIX B Hazard Analysis and Critical Control Point Principles and Application Guidelines

The following is excerpted from a document issued by the National Advisory Committee on Microbiological Criteria for Foods in August 1997. EXECUTIVE SUMMARY The National Advisory Committee on Microbiological Criteria for Foods (Committee) reconvened a Hazard Analysis and Critical Control Point (HACCP) Working Group in 1995. The primary goal was to review the Committee’s November 1992 HACCP document, comparing it to current HACCP guidance prepared by the Codex Committee on Food Hygiene. Based upon its review, the Committee made the HACCP principles more concise; revised and added deﬁnitions; included sections on prerequisite programs, education and training, and implementation and maintenance of the HACCP plan; revised and provided a more detailed explanation of the application of HACCP principles; and provided an additional decision tree for identifying critical control points (CCPs). The Committee again endorses HACCP as an effective and rational means of assuring food safety from harvest to consumption. Preventing problems from occurring is the paramount goal underlying any HACCP system. Seven basic principles are employed in the development of HACCP plans that meet the stated goal. These principles include hazard analysis, CCP identiﬁcation, establishing critical limits, monitoring procedures, corrective actions, veriﬁcation procedures, and record-keeping and documentation. Under such systems, if a deviation occurs indicating that control has been lost, the deviation is detected and appropriate steps are taken to reestablish control in a timely manner to assure that potentially hazardous products do not reach the consumer. In the application of HACCP, the use of microbiological testing is seldom an effective means of monitoring CCPs because of the time required to obtain results. In most instances, monitoring of CCPs can best be accomplished through the use of physical and © 2003 by Marcel Dekker, Inc.

chemical tests, and through visual observations. Microbiological criteria do, however, play a role in verifying that the overall HACCP system is working. The Committee believes that the HACCP principles should be standardized to provide uniformity in training and applying the HACCP system by industry and government. In accordance with the National Academy of Sciences recommendation, the HACCP system must be developed by each food establishment and tailored to its individual product, processing and distribution conditions. In keeping with the Committee’s charge to provide recommendations to its sponsoring agencies regarding microbiological food safety issues, this document focuses on this area. The Committee recognizes that in order to assure food safety, properly designed HACCP systems must also consider chemical and physical hazards in addition to other biological hazards. For a successful HACCP program to be properly implemented, management must be committed to a HACCP approach. A commitment by management will indicate an awareness of the beneﬁts and costs of HACCP and include education and training of employees. Beneﬁts, in addition to enhanced assurance of food safety, are better use of resources and timely response to problems. The Committee designed this document to guide the food industry and advise its sponsoring agencies in the implementation of HACCP systems. DEFINITIONS CCP decision tree: A sequence of questions to assist in determining whether a control point is a CCP. Control: (a) To manage the conditions of an operation to maintain compliance with established criteria. (b) The state where correct procedures are being followed and criteria are being met. Control measure: Any action or activity that can be used to prevent, eliminate or reduce a signiﬁcant hazard. Control point: Any step at which biological, chemical, or physical factors can be controlled. Corrective action: Procedures followed when a deviation occurs. Criterion: A requirement on which a judgement or decision can be based. Critical control point: A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Critical limit: A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. Deviation: Failure to meet a critical limit. HACCP: A systematic approach to the identiﬁcation, evaluation, and control of food safety hazards. HACCP plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed. HACCP system: The result of the implementation of the HACCP Plan. HACCP team: The group of people who are responsible for developing, implementing and maintaining the HACCP system. Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control. © 2003 by Marcel Dekker, Inc.

Hazard analysis: The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are signiﬁcant and must be addressed in the HACCP plan. Monitor: To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in veriﬁcation. Prerequisite programs: Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system. Severity: The seriousness of the effect(s) of a hazard. Step: A point, procedure, operation or stage in the food system from primary production to ﬁnal consumption. Validation: That element of veriﬁcation focused on collecting and evaluating scientiﬁc and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards. Veriﬁcation: Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.

HACCP PRINCIPLES HACCP is a systematic approach to the identiﬁcation, evaluation, and control of food safety hazards based on the following seven principles: Principle Principle Principle Principle Principle Principle Principle

1: 2: 3: 4: 5: 6: 7:

Conduct a hazard analysis. Determine the critical control points (CCPs). Establish critical limits. Establish monitoring procedures. Establish corrective actions. Establish veriﬁcation procedures. Establish record-keeping and documentation procedures.

GUIDELINES FOR APPLICATION OF HACCP PRINCIPLES Introduction HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the ﬁnished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A ﬁrm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food. HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world. © 2003 by Marcel Dekker, Inc.

The following guidelines will facilitate the development and implementation of effective HACCP plans. While the speciﬁc application of HACCP to manufacturing facilities is emphasized here, these guidelines should be applied as appropriate to each segment of the food industry under consideration. Prerequisite Programs The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Examples of common prerequisite programs are listed in Appendix A. Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs. These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are speciﬁed in federal, state and local regulations and guidelines (e.g., cGMPs and Food Code). The Codex Alimentarius General Principles of Food Hygiene describe the basic conditions and practices expected for foods intended for international trade. In addition to the requirements speciﬁed in regulations, industry often adopts policies and procedures that are speciﬁc to their operations. Many of these are proprietary. While prerequisite programs may impact upon the safety of a food, they also are concerned with ensuring that foods are wholesome and suitable for consumption (Appendix B.1). HACCP plans are narrower in scope, being limited to ensuring food is safe to consume. The existence and effectiveness of prerequisite programs should be assessed during the design and implementation of each HACCP plan. All prerequisite programs should be documented and regularly audited. Prerequisite programs are established and managed separately from the HACCP plan. Certain aspects, however, of a prerequisite program may be incorporated into a HACCP plan. For example, many establishments have preventive maintenance procedures for processing equipment to avoid unexpected equipment failure and loss of production. During the development of a HACCP plan, the HACCP team may decide that the routine maintenance and calibration of an oven should be included in the plan as an activity of veriﬁcation. This would further ensure that all the food in the oven is cooked to the minimum internal temperature that is necessary for food safety. Education and Training The success of a HACCP system depends on educating and training management and employees in the importance of their role in producing safe foods. This should also include information on the control of foodborne hazards related to all stages of the food chain. It is important to recognize that employees must ﬁrst understand what HACCP is and then learn the skills necessary to make it function properly. Speciﬁc training activities should include working instructions and procedures that outline the tasks of employees monitoring each CCP. Management must provide adequate time for thorough education and training. Personnel must be given the materials and equipment necessary to perform these tasks. Effective training is an important prerequisite to successful implementation of a HACCP plan. Developing a HACCP Plan The format of HACCP plans will vary. In many cases the plans will be product and process speciﬁc. However, some plans may use a unit operations approach. Generic HACCP plans

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can serve as useful guides in the development of process and product HACCP plans; however, it is essential that the unique conditions within each facility be considered during the development of all components of the HACCP plan. In the development of a HACCP plan, ﬁve preliminary tasks need to be accomplished before the application of the HACCP principles to a speciﬁc product and process. 1. 2. 3. 4. 5.

Assemble the HACCP team. Describe the food and its distribution. Describe the intended use and consumers of the food. Develop a ﬂow diagram that describes the process. Verify the ﬂow diagram.

Assemble the HACCP Team The ﬁrst task in developing a HACCP plan is to assemble a HACCP team consisting of individuals who have speciﬁc knowledge and expertise appropriate to the product and process. It is the team’s responsibility to develop the HACCP plan. The team should be multidisciplinary and include individuals from areas such as engineering, production, sanitation, quality assurance, and food microbiology. The team should also include local personnel who are involved in the operation as they are more familiar with the variability and limitations of the operation. In addition, this fosters a sense of ownership among those who must implement the plan. The HACCP team may need assistance from outside experts who are knowledgeable in the potential biological, chemical and/or physical hazards associated with the product and the process. However, a plan which is developed totally by outside sources may be erroneous, incomplete, and lacking in support at the local level. Due to the technical nature of the information required for hazard analysis, it is recommended that experts who are knowledgeable in the food process should either participate in or verify the completeness of the hazard analysis and the HACCP plan. Such individuals should have the knowledge and experience to correctly: (a) conduct a hazard analysis; (b) identify potential hazards; (c) identify hazards which must be controlled; (d) recommend controls, critical limits, and procedures for monitoring and veriﬁcation; (e) recommend appropriate corrective actions when a deviation occurs; (f ) recommend research related to the HACCP plan if important information is not known; and (g) validate the HACCP plan. Describe the Food and Its Distribution The HACCP team ﬁrst describes the food. This consists of a general description of the food, ingredients, and processing methods. The method of distribution should be described along with information on whether the food is to be distributed frozen, refrigerated, or at ambient temperature. Describe the Intended Use and Consumers of the Food Describe the normal expected use of the food. The intended consumers may be the general public or a particular segment of the population (e.g., infants, immunocompromised individuals, the elderly, etc.). Develop a Flow Diagram which Describes the Process The purpose of a ﬂow diagram is to provide a clear, simple outline of the steps involved in the process. The scope of the ﬂow diagram must cover all the steps in the process which are directly under the control of the establishment. In addition, the ﬂow diagram

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can include steps in the food chain which are before and after the processing that occurs in the establishment. The ﬂow diagram need not be as complex as engineering drawings. A block type ﬂow diagram is sufﬁciently descriptive (see Appendix B.2). Also, a simple schematic of the facility is often useful in understanding and evaluating product and process ﬂow. Verify the Flow Diagram The HACCP team should perform an on-site review of the operation to verify the accuracy and completeness of the ﬂow diagram. Modiﬁcations should be made to the ﬂow diagram as necessary and documented. After these ﬁve preliminary tasks have been completed, the seven principles of HACCP are applied. Conduct a Hazard Analysis (Principle 1) After addressing the preliminary tasks discussed above, the HACCP team conducts a hazard analysis and identiﬁes appropriate control measures. The purpose of the hazard analysis is to develop a list of hazards which are of such signiﬁcance that they are reasonably likely to cause injury or illness if not effectively controlled. Hazards that are not reasonably likely to occur would not require further consideration within a HACCP plan. It is important to consider in the hazard analysis the ingredients and raw materials, each step in the process, product storage and distribution, and ﬁnal preparation and use by the consumer. When conducting a hazard analysis, safety concerns must be differentiated from quality concerns. A hazard is deﬁned as a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the word hazard as used in this document is limited to safety. A thorough hazard analysis is the key to preparing an effective HACCP plan. If the hazard analysis is not done correctly and the hazards warranting control within the HACCP system are not identiﬁed, the plan will not be effective regardless of how well it is followed. The hazard analysis and identiﬁcation of associated control measures accomplish three objectives: Those hazards and associated control measures are identiﬁed. The analysis may identify needed modiﬁcations to a process or product so that product safety is further assured or improved. The analysis provides a basis for determining CCPs in Principle 2. The process of conducting a hazard analysis involves two stages. The ﬁrst, hazard identiﬁcation, can be regarded as a brain storming session. During this stage, the HACCP team reviews the ingredients used in the product, the activities conducted at each step in the process and the equipment used, the ﬁnal product and its method of storage and distribution, and the intended use and consumers of the product. Based on this review, the team develops a list of potential biological, chemical or physical hazards which may be introduced, increased, or controlled at each step in the production process. Appendix B.3 lists examples of questions that may be helpful to consider when identifying potential hazards. Hazard identiﬁcation focuses on developing a list of potential hazards associated with each process step under direct control of the food operation. A knowledge of any adverse health-related events historically associated with the product will be of value in this exercise. After the list of potential hazards is assembled, stage two, the hazard evaluation, is © 2003 by Marcel Dekker, Inc.

conducted. In stage two of the hazard analysis, the HACCP team decides which potential hazards must be addressed in the HACCP plan. During this stage, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence. Severity is the seriousness of the consequences of exposure to the hazard. Considerations of severity (e.g., impact of sequelae, and magnitude and duration of illness or injury) can be helpful in understanding the public health impact of the hazard. Consideration of the likely occurrence is usually based upon a combination of experience, epidemiological data, and information in the technical literature. When conducting the hazard evaluation, it is helpful to consider the likelihood of exposure and severity of the potential consequences if the hazard is not properly controlled. In addition, consideration should be given to the effects of short term as well as long term exposure to the potential hazard. Such considerations do not include common dietary choices which lie outside of HACCP. During the evaluation of each potential hazard, the food, its method of preparation, transportation, storage and persons likely to consume the product should be considered to determine how each of these factors may inﬂuence the likely occurrence and severity of the hazard being controlled. The team must consider the inﬂuence of likely procedures for food preparation and storage and whether the intended consumers are susceptible to a potential hazard. However, there may be differences of opinion, even among experts, as to the likely occurrence and severity of a hazard. The HACCP team may have to rely upon the opinion of experts who assist in the development of the HACCP plan. Hazards identiﬁed in one operation or facility may not be signiﬁcant in another operation producing the same or a similar product. For example, due to differences in equipment and/or an effective maintenance program, the probability of metal contamination may be signiﬁcant in one facility but not in another. A summary of the HACCP team deliberations and the rationale developed during the hazard analysis should be kept for future reference. This information will be useful during future reviews and updates of the hazard analysis and the HACCP plan. Appendix B.4 gives three examples of using a logic sequence in conducting a hazard analysis. While these examples relate to biological hazards, chemical and physical hazards are equally important to consider. Appendix B.4 is for illustration purposes to further explain the stages of hazard analysis for identifying hazards. Hazard identiﬁcation and evaluation as outlined in Appendix B.4 may eventually be assisted by biological risk assessments as they become available. While the process and output of a risk assessment (NACMCF, 1997) [1] is signiﬁcantly different from a hazard analysis, the identiﬁcation of hazards of concern and the hazard evaluation may be facilitated by information from risk assessments. Thus, as risk assessments addressing speciﬁc hazards or control factors become available, the HACCP team should take these into consideration. Upon completion of the hazard analysis, the hazards associated with each step in the production of the food should be listed along with any measure(s) that are used to control the hazard(s). The term control measure is used because not all hazards can be prevented, but virtually all can be controlled. More than one control measure may be required for a speciﬁc hazard. On the other hand, more than one hazard may be addressed by a speciﬁc control measure (e.g., pasteurization of milk). For example, if a HACCP team were to conduct a hazard analysis for the production of frozen cooked beef patties (Appendices B.2 and B.4), enteric pathogens (e.g., Salmonella and verotoxin-producing Escherichia coli) in the raw meat would be identiﬁed as hazards. Cooking is a control measure which can be used to eliminate these hazards. The following is an excerpt from a hazard analysis summary table for this product. © 2003 by Marcel Dekker, Inc.

Step 5. Cooking

Potential hazard(s)

Justiﬁcation

Enteric pathogens: e.g., Salmonella verotoxigenic-E. coli

Enteric pathogens have been associated with outbreaks of foodborne illness from undercooked ground beef

Hazard to be addressed in plan? Y/N Y

Control measure(s) Cooking

The hazard analysis summary could be presented in several different ways. One format is a table such as the one given above. Another could be a narrative summary of the HACCP team’s hazard analysis considerations and a summary table listing only the hazards and associated control measures. Determine Critical Control Points (CCPs) (Principle 2) A critical control point is deﬁned as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The potential hazards that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining CCPs. Complete and accurate identiﬁcation of CCPs is fundamental to controlling food safety hazards. The information developed during the hazard analysis is essential for the HACCP team in identifying which steps in the process are CCPs. One strategy to facilitate the identiﬁcation of each CCP is the use of a CCP decision tree (examples of decision trees are given in Appendices B.5 and B.6). Although application of the CCP decision tree can be useful in determining if a particular step is a CCP for a previously identiﬁed hazard, it is merely a tool and not a mandatory element of HACCP. A CCP decision tree is not a substitute for expert knowledge. Critical control points are located at any step where hazards can be either prevented, eliminated, or reduced to acceptable levels. Examples of CCPs may include: thermal processing, chilling, testing ingredients for chemical residues, product formulation control, and testing product for metal contaminants. CCPs must be carefully developed and documented. In addition, they must be used only for purposes of product safety. For example, a speciﬁed heat process, at a given time and temperature designed to destroy a speciﬁc microbiological pathogen, could be a CCP. Likewise, refrigeration of a precooked food to prevent hazardous microorganisms from multiplying, or the adjustment of a food to a pH necessary to prevent toxin formation could also be CCPs. Different facilities preparing similar food items can differ in the hazards identiﬁed and the steps which are CCPs. This can be due to differences in each facility’s layout, equipment, selection of ingredients, processes employed, etc. Establish Critical Limits (Principle 3) A critical limit is a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. Critical limits should not

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be confused with operational limits which are established for reasons other than food safety. Each CCP will have one or more control measures to assure that the identiﬁed hazards are prevented, eliminated or reduced to acceptable levels. Each control measure has one or more associated critical limits. Critical limits may be based upon factors such as: temperature, time, physical dimensions, humidity, moisture level, water activity (a w ), pH, titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory information such as aroma and visual appearance. Critical limits must be scientiﬁcally based. For each CCP, there is at least one criterion for food safety that is to be met. An example of a criterion is a speciﬁc lethality of a cooking process such as a 5D reduction in Salmonella. The critical limits and criteria for food safety may be derived from sources such as regulatory standards and guidelines, literature surveys, experimental results, and experts. An example is the cooking of beef patties (Appendix B.2). The process should be designed to ensure the production of a safe product. The hazard analysis for cooked meat patties identiﬁed enteric pathogens (e.g., verotoxigenic F. coli such as E. coli O157:H7, and salmonellae) as signiﬁcant biological hazards. Furthermore, cooking is the step in the process at which control can be applied to reduce the enteric pathogens to an acceptable level. To ensure that an acceptable level is consistently achieved, accurate information is needed on the probable number of the pathogens in the raw patties, their heat resistance, the factors that inﬂuence the heating of the patties, and the area of the patty which heats the slowest. Collectively, this information forms the scientiﬁc basis for the critical limits that are established. Some of the factors that may affect the thermal destruction of enteric pathogens are listed in the following table. In this example, the HACCP team concluded that a thermal process equivalent to 155°F for 16 seconds would be necessary to assure the safety of this product. To ensure that this time and temperature are attained, the HACCP team for one facility determined that it would be necessary to establish critical limits for the oven temperature and humidity, belt speed (time in oven), patty thickness and composition (e.g., all beef, beef and other ingredients). Control of these factors enables the facility to produce a wide variety of cooked patties, all of which will be processed to a minimum internal temperature of 155°F for 16 seconds. In another facility, the HACCP team may conclude that the best approach is to use the internal patty temperature of 155°F and hold for 16 seconds as critical limits. In this second facility the internal temperature and hold time of the patties are monitored at a frequency to ensure that the critical limits are constantly met as they exit the oven. The example given below applies to the ﬁrst facility.

Process step

Yes

5. Cooking

Yes

Critical limits Oven temperature: °F Time; rate of heating and cooling (belt speed in ft/min): Patty thickness: in. Patty composition: e.g., all beef Oven humidity: % RH

ft/min

Establish Monitoring Procedures (Principle 4) Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in veriﬁcation.

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Monitoring serves three main purposes. First, monitoring is essential to food safety management in that it facilitates tracking of the operation. If monitoring indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, monitoring is used to determine when there is loss of control and a deviation occurs at a CCP, i.e., exceeding or not meeting a critical limit. When a deviation occurs, an appropriate corrective action must be taken. Third, it provides written documentation for use in veriﬁcation. An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a critical limit deviation, monitoring procedures must be effective. Ideally, monitoring should be continuous, which is possible with many types of physical and chemical methods. For example, the temperature and time for the scheduled thermal process of low-acid canned foods is recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufﬁcient, as recorded on the chart, the product from the retort is retained and the disposition determined as in Principle 5. Likewise, pH measurement may be performed continually in ﬂuids or by testing each batch before processing. There are many ways to monitor critical limits on a continuous or batch basis and record the data on charts. Continuous monitoring is always preferred when feasible. Monitoring equipment must be carefully calibrated for accuracy. Assignment of the responsibility for monitoring is an important consideration for each CCP. Speciﬁc assignments will depend on the number of CCPs and control measures and the complexity of monitoring. Personnel who monitor CCPs are often associated with production (e.g., line supervisors, selected line workers and maintenance personnel) and, as required, quality control personnel. Those individuals must be trained in the monitoring technique for which they are responsible, fully understand the purpose and importance of monitoring, be unbiased in monitoring and reporting, and accurately report the results of monitoring. In addition, employees should be trained in procedures to follow when there is a trend towards loss of control so that adjustments can be made in a timely manner to assure that the process remains under control. The person responsible for monitoring must also immediately report a process or product that does not meet critical limits. All records and documents associated with CCP monitoring should be dated and signed or initialed by the person doing the monitoring. When it is not possible to monitor a CCP on a continuous basis, it is necessary to establish a monitoring frequency and procedure that will be reliable enough to indicate that the CCP is under control. Statistically designed data collection or sampling systems lend themselves to this purpose. Most monitoring procedures need to be rapid because they relate to on-line, “realtime” processes and there will not be time for lengthy analytical testing. Examples of monitoring activities include: visual observations and measurement of temperature, time, pH, and moisture level. Microbiological tests are seldom effective for monitoring due to their time-consuming nature and problems with assuring detection of contaminants. Physical and chemical measurements are often preferred because they are rapid and usually more effective for assuring control of microbiological hazards. For example, the safety of pasteurized milk is based upon measurements of time and temperature of heating rather than testing the heated milk to assure the absence of surviving pathogens. With certain foods, processes, ingredients, or imports, there may be no alternative to microbiological testing. However, it is important to recognize that a sampling protocol © 2003 by Marcel Dekker, Inc.

that is adequate to reliably detect low levels of pathogens is seldom possible because of the large number of samples needed. This sampling limitation could result in a false sense of security by those who use an inadequate sampling protocol. In addition, there are technical limitations in many laboratory procedures for detecting and quantitating pathogens and/or their toxins. Establish Corrective Actions (Principle 5) The HACCP system for food safety management is designed to identify health hazards and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal circumstances do not always prevail and deviations from established processes may occur. An important purpose of corrective actions is to prevent foods which may be hazardous from reaching consumers. Where there is a deviation from established critical limits, corrective actions are necessary. Therefore, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance; (b) determine the disposition of non-compliant product and (c) record the corrective actions that have been taken. Speciﬁc corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining disposition of non-compliant product. Establish Veriﬁcation Procedures (Principle 6) Veriﬁcation is deﬁned as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The NAS (1985) [2] pointed out that the major infusion of science in a HACCP system centers on proper identiﬁcation of the hazards, critical control points, critical limits, and instituting proper veriﬁcation procedures. These processes should take place during the development and implementation of the HACCP plans and maintenance of the HACCP system. An example of a veriﬁcation schedule is given in the table.

Activity Veriﬁcation activities scheduling Initial validation of HACCP plan

Frequency

Yearly or upon HACCP system change Prior to and during initial implementation of plan Subsequent validation When critical limits of HACCP plan changed, signiﬁcant changes in process, equipment changed, after system failure, etc.

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Responsibility

Reviewer

HACCP coordinator

Plant manager

Independent expert(s) a

HACCP team

Independent expert(s) a

HACCP team

Activity

Frequency

Veriﬁcation of CCP According to HACCP monitoring as deplan (e.g., once per scribed in the plan shift) (e.g., monitoring of patty cooking temperature) Review of monitorMonthly ing, corrective action records to show compliance with the plan Comprehensive Yearly HACCP system veriﬁcation

Responsibility

Reviewer

According to HACCP According to HACCP plan (e.g., line suplan (e.g., quality pervisor) control)

Quality assurance

HACCP team

Independent expert(s) a

Plant manager

a Done by others than the team writing and implementing the plan. May require additional technical expertise as well as laboratory and plant test studies.

One aspect of veriﬁcation is evaluating whether the facility’s HACCP system is functioning according to the HACCP plan. An effective HACCP system requires little end-product testing, since sufﬁcient validated safeguards are built in early in the process. Therefore, rather than relying on end-product testing, ﬁrms should rely on frequent reviews of their HACCP plan, veriﬁcation that the HACCP plan is being correctly followed, and review of CCP monitoring and corrective action records. Another important aspect of veriﬁcation is the initial validation of the HACCP plan to determine that the plan is scientiﬁcally and technically sound, that all hazards have been identiﬁed and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Information needed to validate the HACCP plan often include (a) expert advice and scientiﬁc studies and (b) in-plant observations, measurements, and evaluations. For example, validation of the cooking process for beef patties should include the scientiﬁc justiﬁcation of the heating times and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to conﬁrm that the conditions of cooking will deliver the required time and temperature to each beef patty. Subsequent validations are performed and documented by a HACCP team or an independent expert as needed. For example, validations are conducted when there is an unexplained system failure; a signiﬁcant product, process or packaging change occurs; or new hazards are recognized. In addition, a periodic comprehensive veriﬁcation of the HACCP system should be conducted by an unbiased, independent authority. Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all ﬂow diagrams and appropriate records from operation of the plan. A comprehensive veriﬁcation is independent of other veriﬁcation procedures and must be performed to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive veriﬁcation identiﬁes deﬁciencies, the HACCP team modiﬁes the HACCP plan as necessary. Veriﬁcation activities are carried out by individuals within a company, third party experts, and regulatory agencies. It is important that individuals doing veriﬁcation have © 2003 by Marcel Dekker, Inc.

appropriate technical expertise to perform this function. The role of regulatory and industry in HACCP was further described by the NACMCF (1994) [3]. Examples of veriﬁcation activities are included as Appendix B.7. Establish Record-Keeping and Documentation Procedures (Principle 7) Generally, the records maintained for the HACCP System should include the following: 1. A summary of the hazard analysis, including the rationale for determining hazards and control measures. 2. The HACCP Plan Listing of the HACCP team and assigned responsibilities. Description of the food, its distribution, intended use, and consumer. Veriﬁed ﬂow diagram. HACCP Plan Summary Table that includes information for: Steps in the process that are CCPs The hazard(s) of concern. Critical limits Monitoring* Corrective actions* Veriﬁcation procedures and schedule* Record-keeping procedures* The following is an example of a HACCP plan summary table:

CCP

Hazards

Critical limit(s)

Monitoring

Corrective Actions

Veriﬁcation

Records

3. Support documentation such as validation records. 4. Records that are generated during the operation of the plan. Examples of HACCP records are given in Appendix B.8. IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN The successful implementation of a HACCP plan is facilitated by commitment from top management. The next step is to establish a plan that describes the individuals responsible for developing, implementing and maintaining the HACCP system. Initially, the HACCP coordinator and team are selected and trained as necessary. The team is then responsible for developing the initial plan and coordinating its implementation. Product teams can be appointed to develop HACCP plans for speciﬁc products. An important aspect in developing these teams is to assure that they have appropriate training. The workers who will be responsible for monitoring need to be adequately trained. Upon completion of the HACCP plan, operator procedures, forms and procedures for monitoring and corrective action are developed. Often it is a good idea to develop a timeline for the activities involved in the initial implementation of the HACCP plan. Implementation of the HACCP system

* A brief summary of position responsible for performing the activity and the procedures and frequency should be provided.

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involves the continual application of the monitoring, record-keeping, corrective action procedures and other activities as described in the HACCP plan. Maintaining an effective HACCP system depends largely on regularly scheduled veriﬁcation activities. The HACCP plan should be updated and revised as needed. An important aspect of maintaining the HACCP system is to assure that all individuals involved are properly trained so they understand their role and can effectively fulﬁll their responsibilities. REFERENCES 1. National Advisory Committee on Microbiological Criteria for Foods. 1997. The principles of risk assessment for illness caused by foodborne biological agents. Adopted April 4, 1997. 2. An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. 1985. National Academy of Sciences, National Academy Press, Washington, DC. 3. National Advisory Committee on Microbiological Criteria for Foods. 1994. The role of regulatory agencies and industry in HACCP. Int. J. Food Microbiol. 21:187–195.

APPENDIX B.1 Examples of Common Prerequisite Programs The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs. These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Common prerequisite programs may include, but are not limited to: Facilities. The establishment should be located, constructed and maintained according to sanitary design principles. There should be linear product ﬂow and trafﬁc control to minimize cross-contamination from raw to cooked materials. Supplier control. Each facility should assure that its suppliers have in place effective GMP and food safety programs. These may be the subject of continuing supplier guarantee and supplier HACCP system veriﬁcation. Speciﬁcations. There should be written speciﬁcations for all ingredients, products, and packaging materials. Production equipment. All equipment should be constructed and installed according to sanitary design principles. Preventive maintenance and calibration schedules should be established and documented. Cleaning and sanitation. All procedures for cleaning and sanitation of the equipment and the facility should be written and followed. A master sanitation schedule should be in place. Personal hygiene. All employees and other persons who enter the manufacturing plant should follow the requirements for personal hygiene. Training. All employees should receive documented training in personal hygiene, GMP, cleaning and sanitation procedures, personal safety, and their role in the HACCP program. Chemical control. Documented procedures must be in place to assure the segregation and proper use of non-food chemicals in the plant. These include cleaning chemicals, fumigants, and pesticides or baits used in or around the plant. Receiving, storage, and shipping. All raw materials and products should be stored under sanitary conditions and the proper environmental conditions such as temperature and humidity to assure their safety and wholesomeness.

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Traceability and recall. All raw materials and products should be lot-coded and a recall system in place so that rapid and complete traces and recalls can be done when a product retrieval is necessary. Pest control. Effective pest control programs should be in place. Other examples of prerequisite programs might include quality assurance procedures; standard operating procedures for sanitation, processes, product formulations and recipes; glass control; procedures for receiving, storage and shipping; labeling; and employee food and ingredient handling practices.

APPENDIX B.2 Example of a ﬂow diagram for the production of frozen cooked beef patties: 1. Receiving (Beef ) ↓ 2. Grinding ↓ 3. Mixing ↓ 4. Forming ↓ 5. Cooking ↓ 6. Freezing ↓ 7. Boxing ↓ 8. Distributing ↓ 9. Reheating ↓ 10. Serving

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APPENDIX B.3 Examples of Questions to be Considered When Conducting a Hazard Analysis The hazard analysis consists of asking a series of questions which are appropriate to the process under consideration. The purpose of the questions is to assist in identifying potential hazards. A. Ingredients 1. Does the food contain any sensitive ingredients that may present microbiological hazards (e.g., Salmonella, Staphylococcus aureus); chemical hazards (e.g., aﬂatoxin, antibiotic or pesticide residues); or physical hazards (stones, glass, metal)? 2. Are potable water, ice and steam used in formulating or in handling the food? 3. What are the sources (e.g., geographical region, speciﬁc supplier)? B. Intrinsic Factors—Physical characteristics and composition (e.g., pH, type of acidulants, fermentable carbohydrate, water activity, preservatives) of the food during and after processing. 1. What hazards may result if the food composition is not controlled? 2. Does the food permit survival or multiplication of pathogens and/or toxin formation in the food during processing? 3. Will the food permit survival or multiplication of pathogens and/or toxin formation during subsequent steps in the food chain? 4. Are there other similar products in the market place? What has been the safety record for these products? What hazards have been associated with the products? C. Procedures used for processing 1. Does the process include a controllable processing step that destroys pathogens? If so, which pathogens? Consider both vegetative cells and spores. 2. If the product is subject to recontamination between processing (e.g., cooking, pasteurizing) and packaging, which biological, chemical or physical hazards are likely to occur? D. Microbial content of the food 1. What is the normal microbial content of the food? 2. Does the microbial population change during the normal time the food is stored prior to consumption? 3. Does the subsequent change in microbial population alter the safety of the food? 4. Do the answers to the above questions indicate a high likelihood of certain biological hazards? E. Facility design 1. Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat (RTE) foods if this is important to food safety? If not, what hazards should be considered as possible contaminants of the RTE products? 2. Is positive air pressure maintained in product packaging areas? Is this essential for product safety? 3. Is the trafﬁc pattern for people and moving equipment a signiﬁcant source of contamination? F. Equipment design and use 1. Will the equipment provide the time-temperature control that is necessary for safe food? 2. Is the equipment properly sized for the volume of food that will be processed? 3. Can the equipment be sufﬁciently controlled so that the variation in performance will be within the tolerances required to produce a safe food? 4. Is the equipment reliable or is it prone to frequent breakdowns? 5. Is the equipment designed so that it can be easily cleaned and sanitized?

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G.

H.

I.

J.

K.

L.

6. Is there a chance for product contamination with hazardous substances; e.g., glass? 7. What product safety devices are used to enhance consumer safety? • metal detectors • magnets • sifters • ﬁlters • screens • thermometers • bone removal devices • dud detectors 8. To what degree will normal equipment wear affect the likely occurrence of a physical hazard (e.g., metal) in the product? 9. Are allergen protocols needed in using equipment for different products? Packaging 1. Does the method of packaging affect the multiplication of microbial pathogens and/ or the formation of toxins? 2. Is the package clearly labeled “Keep Refrigerated” if this is required for safety? 3. Does the package include instructions for the safe handling and preparation of the food by the end user? 4. Is the packaging material resistant to damage thereby preventing the entrance of microbial contamination? 5. Are tamper-evident packaging features used? 6. Is each package and case legibly and accurately coded? 7. Does each package contain the proper label? 8. Are potential allergens in the ingredients included in the list of ingredients on the label? Sanitation 1. Can sanitation have an impact upon the safety of the food that is being processed? 2. Can the facility and equipment be easily cleaned and sanitized to permit the safe handling of food? 3. Is it possible to provide sanitary conditions consistently and adequately to assure safe foods? Employee health, hygiene and education 1. Can employee health or personal hygiene practices impact upon the safety of the food being processed? 2. Do the employees understand the process and the factors they must control to assure the preparation of safe foods? 3. Will the employees inform management of a problem which could impact upon safety of food? Conditions of storage between packaging and the end user 1. What is the likelihood that the food will be improperly stored at the wrong temperature? 2. Would an error in improper storage lead to a microbiologically unsafe food? Intended use 1. Will the food be heated by the consumer? 2. Will there likely be leftovers? Intended consumer 1. Is the food intended for the general public? 2. Is the food intended for consumption by a population with increased susceptibility to illness (e.g., infants, the aged, the inﬁrmed, immunocompromised individuals)? 3. Is the food to be used for institutional feeding or the home?

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APPENDIX B.4

Examples of How the Stages of Hazard Analysis Are Used to Identify and Evaluate Hazards a

Hazard Analysis Stage

Frozen cooked beef patties produced in a manufacturing plant

Product containing eggs prepared Commercial frozen pre-cooked, for foodservice boned chicken for further processing

Stage 1 Hazard Identiﬁcation

Determine potential hazards associated with product

Enteric pathogens (i.e., E. coli O157:H7 and Salmonella)

Salmonella in ﬁnished product.

Stage 2 Hazard Evaluation

Assess severity of health consequences if potential hazard is not properly controlled.

Epidemiological evidence indiSalmonellosis is a foodborne in- Certain strains of S. aureus procates that these pathogens fection causing a moderate to duce an enterotoxin which can cause severe health effects insevere illness that can be cause a moderate foodborne illcluding death among children caused by ingestion of only a ness. and elderly. Undercooked beef few cells of Salmonella. patties have been linked to disease from these pathogens. E. coli O157:H7 is of very low Product is made with liquid eggs Product may be contaminated probability and salmonellae is which have been associated with S. aureus due to human of moderate probability in raw with past outbreaks of salmohandling during boning of meat. nellosis. Recent problems with cooked chicken. Enterotoxin Salmonella serotype Enteriticapable of causing illness will dis in eggs cause increased only occur as S. aureus multiconcern. Probability of Salmoplies to about 1,000,000/g. Opnella in raw eggs cannot be erating procedures during bonruled out. ing and subsequent freezing If not effectively controlled, prevent growth of S. aureus, some consumers are likely to thus the potential for enterobe exposed to Salmonella toxin formation is very low. from this food.

Determine likelihood of occurrence of potential hazard if not properly controlled.

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Staphylococcus aureus in ﬁnished product.

Using information above, deter- The HACCP team decides that mine if this potential hazard is enteric pathogens are hazards to be addressed in the for this product. HACCP plan. Hazards must be addressed in the plan.

HACCP team determines that if the potential hazard is not properly controlled, consumption of product is likely to result in an unacceptable health risk. Hazard must be addressed in the plan.

The HACCP team determines that the potential for enterotoxin formation is very low. However, it is still desirable to keep the initial number of S. aureus organisms low. Employee practices that minimize contamination, rapid carbon dioxide freezing and handling instructions have been adequate to control this potential hazard. Potential hazard does not need to be addressed in plan.

a For illustrative purposes only. The potential hazards identiﬁed may not be the only hazards associated with the products listed. The responses may be different for different establishments.

© 2003 by Marcel Dekker, Inc.

APPENDIX B.5 Example I of a CCP Decision Tree Important considerations when using the decision tree: The decision tree is used after the hazard analysis. The decision tree then is used at the steps where a hazard that must be addressed in the HACCP plan has been identiﬁed. A subsequent step in the process may be more effective for controlling a hazard and may be the preferred CCP. More than one step in a process may be involved in controlling a hazard. More than one hazard may be controlled by a speciﬁc control measure. Q1.

Q2.

Q3.

Does this step involve a hazard of sufﬁcient likelihood of occurrence and severity to warrant its control? ↓ ↓ YES NO → Not a CCP ↓ Does a control measure for the hazard exist at this step? ↓ ↓ ↑ YES NO Modify the step, ↓ ↓ process or product ↓ Is control at this step ↑ ↓ necessary for safety? → YES ↓ ↓ ↓ NO → Not a CCP → STOP* Is control at this step necessary to prevent, eliminate, or reduce the risk of the hazard to consumers? ↓ ↓ YES NO → Not a CCP → STOP* ↓ CCP

* Proceed to next step in the process.

APPENDIX B.6 Example II of a CCP Decision Tree Q1.

Q2.

Do control measure(s) exist for the identiﬁed hazard? ↓ ↓ ↓ ↑ YES NO Modify step, process or product ↓ ↓ ↑ ↓ Is control at this step necessary for safety? → YES ↓ ↓ ↓ NO → Not a CCP → STOP* Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level? ↓ ↓ NO YES ↓ ↓

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Q3.

Could contamination with the identiﬁed hazard(s) occur in excess of acceptable level(s) or could it increase to an unacceptable level(s)? ↓ ↓ YES NO → Not a CCP → STOP* ↓

Q4.

Will a subsequent step eliminate the identiﬁed hazard(s) or reduce its likely occurrence to an acceptable level? ↓ YES → Not a CCP → STOP*

↓ NO ↓ CRITICAL CONTROL POINT

↓ ↓ ↓ ↓ ↓ ↓ ↓ ↓ ↓ ↓

* Proceed to next step in the described process.

APPENDIX B.7 Examples of Veriﬁcation Activities A. Veriﬁcation procedures may include: 1. Establishment of appropriate veriﬁcation schedules. 2. Review of the HACCP plan for completeness. 3. Conﬁrmation of the accuracy of the ﬂow diagram. 4. Review of the HACCP system to determine if the facility is operating according to the HACCP plan. 5. Review of CCP monitoring records. 6. Review of records for deviations and corrective actions. 7. Validation of critical limits to conﬁrm that they are adequate to control signiﬁcant hazards. 8. Validation of HACCP plan, including on-site review. 9. Review of modiﬁcations of the HACCP plan. 10. Sampling and testing to verify CCPs. B. Veriﬁcation should be conducted: 1. Routinely, or on an unannounced basis, to assure CCPs are under control. 2. When there are emerging concerns about the safety of the product. 3. When foods have been implicated as a vehicle of foodborne disease. 4. To conﬁrm that changes have been implemented correctly after a HACCP plan has been modiﬁed. 5. To assess whether a HACCP plan should be modiﬁed due to a change in the process, equipment, ingredients, etc. C. Veriﬁcation reports may include information on the presence and adequacy of: 1. The HACCP plan and the person(s) responsible for administering and updating the HACCP plan. 2. The records associated with CCP monitoring. 3. Direct recording of monitoring data of the CCP while in operation. 4. Certiﬁcation that monitoring equipment is properly calibrated and in working order. 5. Corrective actions for deviations. 6. Sampling and testing methods used to verify that CCPs are under control. 7. Modiﬁcations to the HACCP plan. 8. Training and knowledge of individuals responsible for monitoring CCPs. 9. Validation activities.

© 2003 by Marcel Dekker, Inc.

APPENDIX B.8 Examples of HACCP Records A. Ingredients for which critical limits have been established. 1. Supplier certiﬁcation records documenting compliance of an ingredient with a critical limit. 2. Processor audit records verifying supplier compliance. 3. Storage records (e.g., time, temperature) for when ingredient storage is a CCP. B. Processing, storage and distribution records 1. Information that establishes the efﬁcacy of a CCP to maintain product safety. 2. Data establishing the safe shelf life of the product; if age of product can affect safety. 3. Records indicating compliance with critical limits when packaging materials, labeling or sealing speciﬁcations are necessary for food safety. 4. Monitoring records. 5. Veriﬁcation records. C. Deviation and corrective action records. D. Employee training records that are pertinent to CCPs and the HACCP plan. E. Documentation of the adequacy of the HACCP plan from a knowledgeable HACCP expert.

© 2003 by Marcel Dekker, Inc.

APPENDIX C Food Code 2001 Recommendations of the U.S. Public Health Service Food and Drug Administration

The following is excerpted from the FDA’s Food Code Recommendations 2001. The Food Code is a model for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. It represents FDA’s best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service. This model is offered for adoption by local, state, and federal governmental jurisdictions for administration by the various departments, agencies, bureaus, divisions, and other units within each jurisdiction that have been delegated compliance responsibilities for food service, retail food stores, or food vending operations. Alternatives that offer an equivalent level of public health protection to ensure that food at retail and foodservice is safe are recognized in this model. This guidance represents FDA’s current thinking on safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance is being issued in accordance with FDA’s Good Guidance Practices regulation (21 CFR 10.115; 65 FR 56468; September 19, 2000). TABLE OF CONTENTS Chapter 1 Purpose and Deﬁnitions 1-1

TITLE, 1-101 1-102 1-103

INTENT, SCOPE Title Intent Scope

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1-2

DEFINITIONS 1-201 Applicability and Terms Deﬁned

Chapter 2 Management and Personnel 2-1

2-2 2-3

2-4

SUPERVISION 2-101 Responsibility 2-102 Knowledge 2-103 Duties EMPLOYEE HEALTH 2-201 Disease or Medical Condition PERSONAL CLEANLINESS 2-301 Hands and Arms 2-302 Fingernails 2-303 Jewelry 2-304 Outer Clothing HYGIENIC PRACTICES 2-401 Food Contamination Prevention 2-402 Hair Restraints 2-403 Animals

Chapter 3 Food 3-1 3-2

3-3

3-4

3-5

CHARACTERISTICS 3-101 Condition SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND RECORDS 3-201 Sources 3-202 Speciﬁcations for Receiving 3-203 Original Containers and Records PROTECTION FROM CONTAMINATION AFTER RECEIVING 3-301 Preventing Contamination by Employees 3-302 Preventing Food and Ingredient Contamination 3-303 Preventing Contamination from Ice Used as a Coolant 3-304 Preventing Contamination from Equipment, Utensils, and Linens 3-305 Preventing Contamination from the Premises 3-306 Preventing Contamination by Consumers 3-307 Preventing Contamination from Other Sources DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN 3-401 Cooking 3-402 Freezing 3-403 Reheating 3-404 Other Methods LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN 3-501 Temperature and Time Control 3-502 Specialized Processing Methods

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3-6

3-7 3-8

FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING 3-601 Accurate Representation 3-602 Labeling 3-603 Consumer Advisory CONTAMINATED FOOD 3-701 Disposition SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS 3-801 Additional Safeguards

Chapter 4 Equipment, Utensils, and Linens 4-1

4-2

4-3

4-4

4-5

4-6

4-7

4-8

4-9

MATERIALS FOR CONSTRUCTION AND REPAIR 4-101 Multiuse 4-102 Single-Service and Single-Use DESIGN AND CONSTRUCTION 4-201 Durability and Strength 4-202 Cleanability 4-203 Accuracy 4-204 Functionality 4-205 Acceptability NUMBERS AND CAPACITIES 4-301 Equipment 4-302 Utensils, Temperature Measuring Devices, and Testing Devices LOCATION AND INSTALLATION 4-401 Location 4-402 Installation MAINTENANCE AND OPERATION 4-501 Equipment 4-502 Utensils and Temperature and Pressure Measuring Devices CLEANING OF EQUIPMENT AND UTENSILS 4-601 Objective 4-602 Frequency 4-603 Methods SANITIZATION OF EQUIPMENT AND UTENSILS 4-701 Objective 4-702 Frequency 4-703 Methods LAUNDERING 4-801 Objective 4-802 Frequency 4-803 Methods PROTECTION OF CLEAN ITEMS 4-901 Drying 4-902 Lubricating and Reassembling 4-903 Storing 4-904 Handling

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Chapter 5 Water, Plumbing, and Waste 5-1

5-2

5-3

5-4

5-5

WATER 5-101 Source 5-102 Quality 5-103 Quantity and Availability 5-104 Distribution, Delivery, and Retention PLUMBING SYSTEM 5-201 Materials 5-202 Design, Construction, and Installation 5-203 Numbers and Capacities 5-204 Location and Placement 5-205 Operation and Maintenance MOBILE WATER TANK AND MOBILE FOOD ESTABLISHMENT WATER TANK 5-301 Materials 5-302 Design and Construction 5-303 Numbers and Capacities 5-304 Operation and Maintenance SEWAGE, OTHER LIQUID WASTE, AND RAINWATER 5-401 Mobile Holding Tank 5-402 Retention, Drainage, and Delivery 5-403 Disposal Facility REFUSE, RECYCLABLES, AND RETURNABLES 5-501 Facilities on the Premises 5-502 Removal 5-503 Facilities for Disposal and Recycling

Chapter 6 Physical Facilities 6-1

6-2

6-3

6-4

MATERIALS FOR CONSTRUCTION AND REPAIR 6-101 Indoor Areas 6-102 Outdoor Areas DESIGN, CONSTRUCTION, AND INSTALLATION 6-201 Cleanability 6-202 Functionability NUMBERS AND CAPACITIES 6-301 Handwashing Facilities 6-302 Toilets and Urinals 6-303 Lighting 6-304 Ventilation 6-305 Dressing Areas and Lockers 6-306 Service Sinks LOCATION AND PLACEMENT 6-401 Handwashing Facilities 6-402 Toilet Rooms 6-403 Employee Accommodations 6-404 Distressed Merchandise 6-405 Refuse, Recyclables, and Returnables

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6-5

MAINTENANCE AND OPERATION 6-501 Premises, Structures, Attachments, and Fixtures—Methods

Chapter 7 Poisonous or Toxic Materials 7-1

7-2

7-3

LABELING AND IDENTIFICATION 7-101 Original Containers 7-102 Working Containers OPERATIONAL SUPPLIES AND APPLICATIONS 7-201 Storage 7-202 Presence and Use 7-203 Container Prohibitions 7-204 Chemicals 7-205 Lubricants 7-206 Pesticides 7-207 Medicines 7-208 First Aid Supplies 7-209 Other Personal Care Items STOCK AND RETAIL SALE 7-301 Storage and Display

Chapter 8 Compliance and Enforcement 8-1

8-2

8-3

8-4

8-5

CODE APPLICABILITY 8-101 Use for Intended Purpose 8-102 Additional Requirements 8-103 Variances PLAN SUBMISSION AND APPROVAL 8-201 Facility and Operating Plans 8-202 Conﬁdentiality 8-203 Construction Inspection and Approval PERMIT TO OPERATE 8-301 Requirement 8-302 Application Procedure 8-303 Issuance 8-304 Conditions of Retention INSPECTION AND CORRECTION OF VIOLATIONS 8-401 Frequency 8-402 Access 8-403 Report of Findings 8-404 Imminent Health Hazard 8-405 Critical Violation 8-406 Noncritical Violation PREVENTION OF FOODBORNE DISEASE TRANSMISSION BY EMPLOYEES 8-501 Investigation and Control

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Annex 1 Compliance and Enforcement 1. 2. 3. 4. 5.

PURPOSE EXPLANATION PRINCIPLE RECOMMENDATION PARTS 8-6 CONSTITUTIONAL PROTECTION 8-7 NOTICES 8-8 REMEDIES

Annex 2 References PART I UNITED STATES CODE AND CODE OF FEDERAL REGULATIONS PART II BIBLIOGRAPHY PREFACE CHAPTER 1 PURPOSE AND DEFINITIONS CHAPTER 2 MANAGEMENT AND PERSONNEL CHAPTER 3 FOOD CHAPTER 4 EQUIPMENT, UTENSILS, AND LINENS CHAPTER 5 WATER, PLUMBING, AND WASTE CHAPTER 6 PHYSICAL FACILITIES PART III FDA SUPPORTING DOCUMENTS A—DRAFT RECOMMENDED VOLUNTARY NATIONAL RETAIL FOOD REGULATORY PROGRAM STANDARDS B—PROCEDURES FOR THE STANDARDIZATION AND CERTIFICATION OF RETAIL FOOD TRAINING/INSPECTION OFFICERS (2000) C—DRAFT MANAGING FOOD SAFETY: A HACCP PRINCIPLES GUIDE FOR OPERATORS OF FOOD SERVICE, RETAIL FOOD STORES, AND OTHER FOOD ESTABLISHMENTS AT THE RETAIL LEVEL (1998) D—PLAN REVIEW GUIDELINES (2000) E—PRE-OPERATIONAL GUIDE FOR TEMPORARY FOOD ESTABLISHMENTS (2000) F—FDA RETAIL FOOD PROGRAM DATABASE OF FOODBORNE ILLNESS RISK FACTORS (2000) Annex 3 Public Health Reasons/Administrative Guidelines CHAPTER CHAPTER CHAPTER CHAPTER CHAPTER CHAPTER CHAPTER

1 2 3 4 5 6 7

PURPOSE AND DEFINITIONS MANAGEMENT AND PERSONNEL FOOD EQUIPMENT, UTENSILS, AND LINENS WATER, PLUMBING, AND WASTE PHYSICAL FACILITIES POISONOUS OR TOXIC MATERIALS

Annex 4 Food Establishment Inspection 1. INTRODUCTION 2. PROGRAM PLANNING © 2003 by Marcel Dekker, Inc.

3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.

STAFF TRAINING CONDUCTING THE INSPECTION INSPECTION DOCUMENTATION INSPECTION REPORT ADMINISTRATIVE PROCEDURES BY THE STATE/LOCAL AUTHORITIES TEMPERATURE MEASURING DEVICES CALIBRATION PROCEDURES HACCP INSPECTION DATA FORM FOOD ESTABLISHMENT INSPECTION REPORT FDA ELECTRONIC INSPECTION SYSTEM ESTABLISHMENT SCORING

Annex 5 HACCP Guidelines 1. 2. 3. 4. 5. 6.

INTRODUCTION HACCP PRINCIPLES SUMMARY ACKNOWLEDGEMENTS BIBLIOGRAPHY OTHER SOURCES OF HACCP INFORMATION TWO TYPICAL FLOW DIAGRAMS

Annex 6 Food Processing 1. 2. 3.

INTRODUCTION REDUCED OXYGEN PACKAGING SMOKING AND CURING

Annex 7 Model Forms, Guides, and Other Aids 1)

2)

3)

4)

Employee health a) Form 1-A b) Form 1-B c) Form 1-C d) Guide 1-D e) Guide 1-E f ) List 1-F

information Applicant and Food Employee Interview Food Employee Reporting Agreement Applicant and Food Employee Medical Referral Exclusions and Restrictions Removal of Exclusions and Restrictions Worldwide Status of Salmonella Typhi, Shigella spp., Escherichia coli O157:H7, and Hepatitis A Virus by Geographical Area Adoption information a) Form 2-A Adoption by Reference b) Form 2-B Adoption by Section-by-Section Reference Inspection information a) Form 3-A HACCP Inspection Data b) Form 3-B Food Establishment Inspection Report c) Guide 3-C Inspectional Guide Summary information a) Chart 4-A Summary Chart for Minimum Cooking Food Temperatures and Holding Times Required by Chapter 3

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b)

Chart 4-B

c)

Chart 4-C

d) e)

Chart 4-D Summary

Summary Chart for Minimum Food Temperatures and Holding Times Required by Chapter 3 for Reheating Foods for Hot Holding Summary Chart—Date Marking and Disposing Ready-to-Eat, Potentially Hazardous Food FDA Food Code Mobile Food Establishment Matrix Summary of Changes in the FDA Food Code

© 2003 by Marcel Dekker, Inc.

APPENDIX D The Handbook of Food Defect Action Levels Levels of Natural or Unavoidable Defects in Foods that Present No Health Hazards for Humans

The following is from the FDA/CFSAN Defect Action Level Handbook. INTRODUCTION Title 21, Code of Federal Regulations, Part 110.110 allows the Food and Drug Administration (FDA) to establish maximum levels of natural or unavoidable defects in foods for human use that present no health hazard. These “Food Defect Action Levels” listed in this booklet are set on this premise—that they pose no inherent hazard to health. Poor manufacturing practices may result in enforcement action without regard to the action level. Likewise, the mixing of blending of food with a defect at or above the current defect action level with another lot of the same or another food is not permitted. That practice renders the ﬁnal food unlawful regardless of the defect level of the ﬁnished food. The FDA set these action levels because it is economically impractical to grow, harvest, or process raw products that are totally free of non-hazardous, naturally occurring, unavoidable defects. Products harmful to consumers are subject to regulatory action whether or not they exceed the action levels. It is incorrect to assume that because the FDA has an established defect action level for a food commodity, the food manufacturer need only stay just below that level. The defect levels do not represent an average of the defects that occur in any of the products—

U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, May 1995; Revised March 1997; Revised May 1998.

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the averages are actually much lower. The levels represent limits at which FDA will regard the food product “adulterated”; and subject to enforcement action under Section 402(a)(3) of the Food, Drug, and Cosmetics Act. As technology improves, the FDA may review and change defect action levels on this list. Also, products may be added to the list. The FDA publishes these revisions as Notices in the Federal Register. It is the responsibility of the user of this booklet to stay current with any changes to this list. PRODUCTS WITHOUT DEFECT LEVELS If there is no defect action level for a product, or when ﬁndings show levels or types of defects that do not appear to ﬁt the action level criteria, FDA evaluates the samples and decides on a case-by-case basis. In this procedure, FDA’s technical and regulatory experts in ﬁlth and extraneous materials use a variety of criteria, often in combination, in determining the signiﬁcance and regulatory impact of the ﬁndings. The criteria considered is based on the reported ﬁndings (e.g., lengths of hairs, sizes of insect fragments, distribution of ﬁlth in the sample, and combinations of ﬁlth types found). Moreover, FDA interprets the ﬁndings considering available scientiﬁc information (e.g., ecology of animal species represented) and the knowledge of how a product is grown, harvested, and processed. USE OF CHEMICAL SUBSTANCES TO ELIMINATE DEFECT LEVELS It is FDA’s position that pesticides are not the alternative to preventing food defects. The use of chemical substances to control insects, rodents and other natural contaminants has little, if any impact on natural and unavoidable defects in foods. The primary use of pesticides in the ﬁeld is to protect food plants from being ravaged by destructive plant pests (leaf feeders, stem borers, etc.). A secondary use of pesticides is for cosmetic purposes—to prevent some food products from becoming so severely damaged by pests that it becomes unﬁt to eat. USING THIS FOOD DEFECT ACTION LEVEL BOOKLET This edition of The Food Defect Action Level includes the source of each defect and the signiﬁcance of it (i.e., how the defect affects the food). Food processors may ﬁnd this information helpful as a quality control tool in their operation. Food commodities (Product) are listed alphabetically. Each listing indicates the analytical methodology (Defect Method) used, as well as the parameters for the defect (Defect Action Level). GLOSSARY The glossary describes terms used throughout this booklet. ABUSE Improper handling. AESTHETIC Offensive to the senses. CONTAMINATION Addition of foreign material, (e.g., dirt, hair, excreta, non-invasive insects, machinery mold) to a product. © 2003 by Marcel Dekker, Inc.

COPEPODS Small free-swimming marine crustaceans, many of which are ﬁsh parasites. In some species the females enter the tissues of the host ﬁsh and may form pus pockets. DAMAGE Refers to the condition of the product which shows the evidence of the pest habitation or feeding, (e.g., tunneling, gnawing, egg cases, etc.). DECOMPOSED Consists of the bacterial breakdown of the normal product tissues and the subsequent enzyme induced chemical changes. These changes are manifested by abnormal odors, taste, texture, color, etc. DECOMPOSITION METABOLITES Compounds such as histamines and diamines, etc. ECONOMIC ADULTERATION Intentional failure to remove inedible materials from the ﬁnished product, or the intentional addition or substitution of cheaper food or ingredient to a product. EXTRANEOUS MATERIALS Any foreign matter in a product associated with objectionable conditions or practices in production, storage, or distribution. Includes: objectionable matter contributed by insects, rodents, and birds; decomposed material; and miscellaneous matter such as sand, soil, glass, rust, or other foreign substances. FOREIGN MATTER Includes objectionable matter such as sticks, stones, burlap bagging, cigarette butts, etc. Also includes the valueless parts of the raw plant material, such as stems. GUMMY A resinous glaze on an almond kernel that is induced by an insect injury or mechanical damage. HARVEST Occurs during the harvesting process. HISTAMINE A chemical compound formed by the bacterial decomposition of seafood. INDOLE A chemical compound formed by the bacterial decomposition of seafood. INFECTION A condition due to the growth of an organism in a host, (e.g., rot or decay, visible mold mycelia). INFESTATION The presence of any live or dead life cycle stages of insects in a host product, (e.g., weevils in pecans, ﬂy eggs and maggots in tomato products); or evidence of their presence (i.e., excreta, cast skins, chewed product residues, urine, etc.); or the establishment of an active breeding population, (e.g., rodents in a grain silo). MILDEW Refers to downy mildew which is a fungus infection that causes yellowbrown spots on the leaves of edible greens in the mustard family. MOLD COUNT Refers to the results of the Howard mold count method which is reported as the percentage of positive microscopic ﬁelds that have been scored as either positive or negative based on the presence or absence of a minimum amount of mold hyphae. Performed only on comminuted fruits and vegetables, and some ground spices. The source of the mold hyphae is rotten raw material that is processed along with sound raw material but is no longer visible due to the comminution process. MOLDY Evidenced by the presence of mold (mold hyphae and/or spore forming structures) that are visible to the unaided eye. Microscopic examination may be used to conﬁrm the presence of characteristic hyphal ﬁlaments and fruiting structures. POST HARVEST Occurs after harvest, for example: 1. ﬁeld holding of the harvested crop prior to transit 2. farm storage of harvested crop 3. during transit by truck, ship, rail, etc. 4. at the processing facility, awaiting processing or proper storage PREHARVEST Occurs while product is in the ﬁeld, during growth or awaiting harvest. © 2003 by Marcel Dekker, Inc.

PROCESSING Occurs while in the processing facility, in storage or during processing RANCID A condition where a product has a disagreeable odor or taste of decomposed oils or fat. For example, rancid nuts frequently are soft, with a yellow, dark, or oily appearance, a bitter taste and a stale odor. ROT Plant tissue that is visibly decomposed, usually discolored with disagreeable odors and taste. The plant tissue has been invaded and is being digested by microorganisms. Although rot can also be caused by bacteria and yeasts, these organisms are secondary invaders. Molds are the primary organisms of decomposition and the presence of mold hyphae in the tissue is used to conﬁrm rot. SHRIVELED A condition where the nut kernel is shrunken and not fully developed, commonly a result of climatic stress or infection by certain molds. SIGNIFICANCE OF DEFECT Refers to the real or potential impact on the consumer due to the presence of a particular defect. A listed defect can have more than one signiﬁcance to the consumer (e.g., the mold defect of whole cassia has an aesthetic signiﬁcance, whereas the mold defect of green coffee beans has a potential health hazard signiﬁcance due to the threat of mold toxins produced by the mold species known to infect coffee beans). SOUR In fruits, consists of the bacterial breakdown of the product and the formation of lactic acid and subsequent sour taste. WATER INSOLUBLE INORGANIC MATTER A contaminant of the ﬁnished product that consists of ﬁne grit that originates from the sand, dirt, and stones that contaminate the raw agricultural product at the time of harvest. WHOLE OR EQUIVALENT INSECT A whole insect, separate head, or body portions with head attached. WORTHLESS Any condition where the product has been affected by organisms or the environment that it has no food value.

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product

Defect (Method)

Action level

ALLSPICE, GROUND

Insect Filth Average of 30 or more insect fragments per 10 grams (AOAC 981.21) Rodent ﬁlth Average of 1 or more rodent hairs per 10 grams (AOAC 981.21) DEFECT SOURCE: Insect fragments—pre/postharvest and processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic ALLSPICE, WHOLE

Mold Average of 5% or more berries by weight are moldy (MPM-V32) DEFECT SOURCE: Preharvest and/or postharvest infection SIGNIFICANCE: Potential health hazard—may contain mycotoxin producing fungi APPLE BUTTER

Mold Average of mold count is 12% or more (AOAC 975.51) Rodent ﬁlth Average of 4 or more rodent hairs per 100 grams of apple butter (AOAC 945.76) Insects Average of 5 or more whole or equivalent insects (not counting mites, aphids, thrips, or scale insects) (AOAC 945.76) per 100 grams of apple butter DEFECT SOURCE: Mold—postharvest infection. Rodent hair—postharvest and/or processing contamination with animal hair. Whole or equivalent insects—preharvest, and/or postharvest and/or processing insect infestation SIGNIFICANCE: Aesthetic APRICOTS, CANNED

Insect ﬁlth (MPM-V51) DEFECT SOURCE: Preharvest insect infestation SIGNIFICANCE: Aesthetic

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Average of 2% or more by count has been damaged or infected by insects

Commodities and Defect Action Levels Product ASPARAGUS, CANNED OR FROZEN

Continued

Defect (Method)

Action level

Insect ﬁlth (MPM-V93)

10% by count of spears or pieces are infested with 6 or more attached asparagus beetle eggs and/or sacs

Insects (MPM-V93)

Asparagus contains an average of 40 or more thrips per 100 grams OR Insects (whole or equivalent) of 3 mm or longer have an average aggregate length of 7 mm or longer per 100 grams of asparagus

DEFECT SOURCE: Preharvest insect infestation SIGNIFICANCE: Aesthetic BAY (LAUREL) LEAVES

Mold Average of 5% or more pieces by weight are moldy (MPM-V92) Insect ﬁlth Average of 5% or more pieces by weight are insect-infested (MPM-V32) Mammalian excreta Average of 1 mg or more mammalian excreta per pound after processing (MPM-V32) DEFECT SOURCE: Mold—preharvest infection. Insect infestation—preharvest and/or postharvest and/or processing insect infestation. Mammalian excreta—postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic BEETS, CANNED Rot DEFECT SOURCE: Preharvest mold infection SIGNIFICANCE: Aesthetic BERRIES Drupelet, Canned and Frozen (blackberries, raspberries, etc.)

Mold (AOAC 955.47) Insects and larvae (AOAC 981.20)

Average of 5% or more pieces by weight with dry rot

Average mold count is 60% or more

Average of 4 or more larvae per 500 grams OR Average of 10 or more whole insects or equivalent per 500 grams (excluding thrips, aphids and mites) DEFECT SOURCE: Insects and larvae—preharvest insect infestation. Mold—postharvest infection SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Lingon, Canned (EuroInsect larvae Average of 3 or more larvae per pound in a minimum of 12 subsamples pean cranberry) (MPM-V64) DEFECT SOURCE: Insects—preharvest insect infestation SIGNIFICANCE: Aesthetic Multer, Canned Insects Average of 40 or more thrips per No. 2 can in all subsamples and 20% of subsamples are materially in(MPM-V64) fested DEFECT SOURCE: Insects—preharvest insect infestation SIGNIFICANCE: Aesthetic BROCCOLI, FROZEN

Insects and mites (AOAC 945.82) DEFECT SOURCE: Preharvest insect infestation SIGNIFICANCE: Aesthetic

Average of 60 or more aphids and/or thrips and/or mites per 100 grams

BRUSSELS SPROUTS, Insects FROZEN (MPM-V95) DEFECT SOURCE: Preharvest insect infestation SIGNIFICANCE: Aesthetic

Average of 30 or more aphids and/or thrips per 100 grams

CAPSICUM: Pods

Insect ﬁlth and/or Average of more than 3% of pods by weight are insect-infested and/or moldy mold (MPM-V32) Mammalian excreta Average of more than 1 mg mammalian excreta per pound (MPM-V32) DEFECT SOURCE: Insect infested—preharvest and/or postharvest insect infestation. Mold—preharvest and/or postharvest infection. Mammalian excreta—postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic, Potential health hazard—mold may contain mycotoxin producing fungi

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product

Defect (Method)

Continued Action level

Ground Capsicum (excluding paprika)

Mold Average mold count is more than 20% (AOAC 945.94) Insect ﬁlth Average of more than 50 insect fragments per 25 grams (AOAC 978.22) Rodent ﬁlth Average of more than 6 rodent hairs per 25 grams (AOAC 978.22) DEFECT SOURCE: Mold—preharvest and/or postharvest mold infection. Insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair—preharvest and/or postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic, Mold may contain mycotoxin producing fungi Ground Paprika Mold Average mold count is more than 20% (AOAC 945.94) Insect ﬁlth Average of more than 75 insect fragments per 25 grams (AOAC 977.25B) Rodent ﬁlth Average of more than 11 rodent hairs per 25 grams (AOAC 977.25B) DEFECT SOURCE: Mold—pre and/or postharvest mold infection. Insect fragments—pre and/or postharvest and/or processing insect infestation. Rodent hair—pre and/or postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic, Potential health hazard—mold may contain mycotoxin producing fungi CASSIA (OR) CINNAMON BARK, WHOLE

Mold Average of 5% or more pieces by weight are moldy (MPM-V32) Insect ﬁlth Average of 5% or more pieces by weight are insect-infested (MPM-V32) Mammalian excreta Average of 1 mg or more mammalian excreta per pound (MPM-V32) DEFECT SOURCE: Mold—postharvest mold infection. Insect infestation—postharvest and/or processing. Mammalian excreta—postharvest and/or processing animal contamination. SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

CINNAMON, GROUND

Insect ﬁlth Average of 400 or more insect fragments per 50 gram (AOAC 968.38b) Rodent ﬁlth Average of 11 or more rodent hairs per 50 grams (AOAC 968.38b) DEFECT SOURCE: Insect fragments—postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic CHERRIES Brined and Maraschino

Insect ﬁlth Average of 5% or more pieces are rejects due to maggots (MPM-V48) DEFECT SOURCE: Preharvest insect infestation SIGNIFICANCE: Aesthetic Fresh, Canned, or Frozen Rot Average of 7% or more pieces are rejects due to rot (MPM-V48) Insect ﬁlth Average of 4% or more pieces are rejects due to insects other than maggots (MPM-V48) DEFECT SOURCE: Insect reject—Preharvest and/or postharvest insect infestation. Rot reject—preharvest mold infection SIGNIFICANCE: Aesthetic CHERRY JAM

Mold (MPM-V61) DEFECT SOURCE: Preharvest mold infection SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Average mold count is 30% or more

Commodities and Defect Action Levels Product CHOCOLATE AND CHOCOLATE LIQUOR

Continued

Defect (Method) Insect ﬁlth (AOAC 965.38) Rodent ﬁlth (AOAC 965.38)

Action level Average is 60 or more insect fragments per 100 grams when 6 100-gram subsamples are examined OR Any 1 subsample contains 90 or more insect fragments Average is 1 or more rodent hairs per 100 grams in 6 100-gram subsamples examined OR Any 1 subsample contains 3 or more rodent hairs For chocolate liquor, if the shell is in excess of 2% calculated on the basis of alkali-free nibs

Shell (AOAC 968.10– 970.23) DEFECT SOURCE: Insect fragments—postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta. Shell—processing contamination SIGNIFICANCE: Aesthetic CITRUS FRUIT JUICES, CANNED

Mold Average mold count is 10% or more (AOAC 970.75) Insects and insect 5 or more Drosophila and other ﬂy eggs per 250 ml or 1 or more maggots per 250 ml eggs (AOAC 970.72) DEFECT SOURCE: Mold—processing contamination, Fly eggs and/or maggots—postharvest insect infestation SIGNIFICANCE: Aesthetic CLOVES

Stems (MPM-V32)

DEFECT SOURCE: Harvest SIGNIFICANCE: Aesthetic, economic adulteration

© 2003 by Marcel Dekker, Inc.

Average of 5% or more stems by weight

COCOA BEANS

Mold More than 4% of beans by count are moldy (MPM-V18) Insect ﬁlth More than 4% of beans by count are insect-infested including insect-damaged (MPM-V18) Insect ﬁlth and/or More than 6% of beans by count are insect-infested or moldy mold NOTE: Level differs when both ﬁlth and mold are present Mammalian excreta Average of 10 mg or more mammalian excreta per pound (MPM-V18) DEFECT SOURCE: Mold—postharvest infection. Insect infested/damaged—postharvest and/or processing insect infestation. Mammalian excreta—postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic, Potential health hazard—may contain mycotoxin producing fungi COCOA POWDER PRESS CAKE

Insect ﬁlth (AOAC 965.38) Rodent ﬁlth (AOAC 965.38)

Average of 75 or more insect fragments per subsample of 50 grams when 6 subsamples are examined OR Any 1 subsample contains 125 or more insect fragments Average in 6 or more subsamples is 2 or more rodent hairs per subsample of 50 grams OR Any 1 subsample contains 4 or more rodent hairs 2% or more shell calculated on the basis of alkali-free nibs.

Shell (AOAC 968.10– 970.23) DEFECT SOURCE: Insect fragments—postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta. Shell—processing contamination SIGNIFICANCE: Aesthetic COFFEE BEANS, Grade defects Beans are poorer than Grade 8 of the New York Green Coffee Association GRADED GREEN (MPM-V6) DEFECT SOURCE: Quality—processing SIGNIFICANCE: Aesthetic, economic adulteration

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product COFFEE BEANS, GREEN

Continued

Defect (Method) Insect ﬁlth and insects (MPM-V1)

Action level Average 10% or more by count are insect-infested or insect-damaged Note: If live external infestation is present use the Compliance Policy Guide (CPG) titled “Food Storage and Warehousing-Adulteration-Filth” (CPG 580.100) in accordance with “Interpretation of Insect Filth” (CPG 555.600) Average of 10% or more beans by count are moldy

Mold (MPM-V1) DEFECT SOURCE: Insect infested/damaged—preharvest and/or postharvest and/or processing insect infestation. Mold—postharvest and/or processing infection SIGNIFICANCE: Aesthetic, Potential health hazard—mold may contain mycotoxin producing fungi CONDIMENTAL Mammalian excreta Average of 3 mg or more of mammalian excreta per pound SEEDS OTHER (MPM-V32) THAN FENNEL SEEDS AND SESAME SEEDS DEFECT SOURCE: Postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic CORN: SWEET CORN, CANNED

Insect larvae (AOAC 973.61)

Insect larvae (corn ear worms, corn borers) 2 or more 3 mm or longer larvae, cast skins, larval or cast skin fragments of corn ear worms or corn borer and the aggregate length of such larvae, cast skins, larval or cast skin fragments exceeds 12 mm in 24 pounds (24 No. 303 cans or equivalent)

DEFECT SOURCE: Preharvest insect infestation SIGNIFICANCE: Aesthetic CORN HUSKS FOR TAMALES

Insect ﬁlth Average of 5% or more husks by weight are insect-infested (including insect-damaged) (MPM-V115) Mold Average of 5% or more husks by weight are moldy (MPM-V115) DEFECT SOURCE: Insect infested—preharvest and/or processing insect infestation. Mold—preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

CORNMEAL

Insects (AOAC 981.19) Insect ﬁlth (AOAC 981.19) Rodent ﬁlth (AOAC 981.19)

Average of 1 or more whole insects (or equivalent) per 50 grams Average of 25 or more insect fragments per 25 grams

Average of 1 or more rodent hairs per 25 grams OR Average of 1 or more rodent excreta fragment per 50 grams DEFECT SOURCE: Insects and insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair and excreta fragments—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic CRANBERRY SAUCE

Mold (AOAC 970.76)

Average mold count is more than 15% OR The mold count of any 1 subsample is more than 50% DEFECT SOURCE: Preharvest and/or postharvest infection SIGNIFICANCE: Aesthetic CUMIN SEED

Sand and grit (AOAC 975.48) DEFECT SOURCE: Harvest contamination SIGNIFICANCE: Aesthetic

Average of 9.5% or more ash and/or 1.5% or more acid insoluble ash

CURRANT JAM, Mold Average mold count is 75% or more BLACK (MPM-V61) DEFECT SOURCE: Postharvest and/or processing infection SIGNIFICANCE: Aesthetic CURRANTS

Insect ﬁlth (MPM-V53) DEFECT SOURCE: Preharvest insect infestation SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

5% or more, by count, wormy in the average of the subsamples

Commodities and Defect Action Levels Product

Defect (Method)

Continued Action level

CURRY POWDER

Insect ﬁlth Average of 100 or more insect fragments per 25 grams (AOAC 975.48) Rodent ﬁlth Average of 4 or more rodent hairs per 25 grams (AOAC 975.48) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic DATE MATERIAL (CHOPPED, SLICED, (OR) MACERATED)

Insects (MPM-V53)

10 or more dead insects (whole or equivalent) in 1 or more subsamples OR 5 or more dead insects (whole or equivalent) per 100 grams 2 or more pits and/or pit fragments 2 mm or longer measured in the longest dimension per 900 grams

Pits (MPM-V53) DEFECT SOURCE: Insects—preharvest and/or postharvest and/or processing insect infestation. Pits—processing SIGNIFICANCE: Insects—Aesthetic. Pits—mouth/tooth injury DATES, PITTED

Multiple Average of 5% or more dates by count are rejects (moldy, dead insects, insect excreta, sour, dirty, (MPM-V53) and/or worthless) as determined by macroscopic sequential examination Pits Average of 2 or more pits and/or pit fragments 2 mm or longer in the longest dimension per 100 dates (MPM-V53) DEFECT SOURCE: Insects, insect excreta, & mold—preharvest and/or postharvest and/or processing. Sour & worthless—preharvest. Dirt—harvest contamination. Pits—processing SIGNIFICANCE: Insects, insect excreta, mold, sour & worthless, dirt—Aesthetic. Pits—mouth/tooth injury DATES, WHOLE

Multiple Average of 5% or more dates by count are rejects (moldy, dead insects, insect excreta, sour, dirty, (MPM-V53) and/or worthless) as determined by macroscopic sequential examination DEFECT SOURCE: Insects, insect excreta, & mold—preharvest and/or postharvest and/or processing. Sour & worthless—preharvest. Dirt—harvest contamination SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

EGGS AND OTHER Decomposition 2 or more cans decomposed and at least 2 subsamples from decomposed cans have direct microscopic EGG PRODUCTS, (AOAC 939.14, counts of 5 million or more bacteria per gram FROZEN 940.36, 940.37) DEFECT SOURCE: Processing (incubator rejects) SIGNIFICANCE: Economic FENNEL SEED

Insects (MPM-V32) Mammalian excreta (MPM-V32)

20% or more of subsamples contain insects

20% or more of subsamples contain mammalian excreta OR average of more than 3 mg of mammalian excreta per pound DEFECT SOURCE: Insects—preharvest and/or postharvest insect infestation, Excreta—postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic FIG PASTE

Insects Contains 13 or more insect heads per 100 grams of ﬁg paste in each of 2 or more subsamples (AOAC 964.23) DEFECT SOURCE: Preharvest and/or postharvest and/or processing insect infestation SIGNIFICANCE: Aesthetic FIGS

Insect ﬁlth and/or Average of 10% or more by count are insect-infested and/or moldy and/or dirty fruit or pieces of fruit mold and/or dirty fruit or pieces of fruit (MPM-V53) DEFECT SOURCE: Insect infested—Preharvest and/or postharvest infestation, Moldy—preharvest infection. Dirt—harvest contamination SIGNIFICANCE: Aesthetic, Potential health hazard—may contain mycotoxin producing fungi

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product FISH, FRESH (OR) FROZEN (APPLIES TO FISH (OR) FILLETS WEIGHING 3 POUNDS (OR) LESS)

Defect (Method) Decomposition

Continued Action level

Decomposition in 5% or more of the ﬁsh (or ﬁllets) show Class 3 decomposition over at least 25% of their areas in 2 or more subsamples OR 20% or more of the ﬁsh (or ﬁllets) show Class 2 decomposition over at least 25% of their areas in 2 or more subsamples OR The percentage of ﬁsh (or ﬁllets) showing Class 2 decomposition plus 4 times the percentage of those showing Class 3 decomposition as above equals at least 20% in 2 or more subsamples ORGANOLEPTIC DECOMPOSITION CLASSES: Class 1—No odors of decomposition Class 2—First deﬁnite odor of decomposition Class 3—Odors of advanced decomposition DEFECT SOURCE: Postharvest time/temperature abuse SIGNIFICANCE: Potential health hazard from decomposition metabolites Tullibees, Ciscoes, Incon- Parasites (cysts) 50 parasitic cysts per 100 pounds (whole or ﬁllets), provided that 20% of the ﬁsh examined are innus, Chubs, and White- (MPM-V28) fested ﬁsh DEFECT SOURCE: Preharvest infection SIGNIFICANCE: Aesthetic Blue Fin and other Fresh Parasites (cysts) 60 parasitic cysts per 100 ﬁsh (ﬁsh averaging 1 pound or less) or 100 pounds of ﬁsh averaging over 1 Water Herring (MPM-V28) pound), provided that 20% of the ﬁsh examined are infested DEFECT SOURCE: Preharvest infection SIGNIFICANCE: Aesthetic Red Fish and Ocean Parasites (cope3% of the ﬁllets examined contain 1 or more copepods accompanied by pus pockets Perch pods) (MPM-V28) DEFECT SOURCE: Preharvest infection SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

GINGER, WHOLE

Insect ﬁlth and/or Average of 3% or more pieces by weight are insect-infested and/or moldy mold (MPM-V32) Mammalian excreta Average of 3 mg or more of mammalian excreta per pound (MPM-V32) DEFECT SOURCE: Insect infestation—postharvest and/or processing. Mold—postharvest and/or processing infection. Mammalian excreta—postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic. Potential health hazard—may contain mycotoxin producing fungi GREENS, CANNED

Mildew (AOAC 967.23) DEFECT SOURCE: Preharvest infection SIGNIFICANCE: Aesthetic

Average of 10% or more of leaves, by count or weight, showing mildew over 1/2″ in diameter

HOPS

Average of more than 2,500 aphids per 10 grams

Insects (AOAC 967.23) DEFECT SOURCE: Preharvest infestation SIGNIFICANCE: Aesthetic MACARONI AND NOODLE PRODUCTS

Insect ﬁlth Average of 225 insect fragments or more per 225 grams in 6 or more subsamples (AOAC 969.41) Rodent ﬁlth Average of 4.5 rodent hairs or more per 225 grams in 6 or more subsamples (AOAC 969.41) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic MACE

Insect ﬁlth and/or Average of 3% or more pieces by weight are insect-infested and/or moldy mold (MPM-V32) Mammalian excreta Average of 3 mg or more of mammalian excreta per pound (MPM-V32) Foreign matter Average of 1.5% or more of foreign matter through a 20-mesh sieve (MPM-V32) DEFECT SOURCE: Insect infestation—preharvest and/or postharvest and/or processing. Mold—preharvest and/or postharvest infection. Mammalian excreta—postharvest and/or processing animal contamination. Foreign matter—postharvest contamination SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product

Defect (Method)

Continued Action level

MARJORAM, WHOLE PLANT, UNPROCESSED

Insect ﬁlth and/or Average of 5% or more pieces by weight are insect-infested or moldy mold (MPM-V32) Mammalian excreta Average of 1 mg or more mammalian excreta per pound (MPM-V32) DEFECT SOURCE: Insect infestation—preharvest and/or postharvest and/or processing. Mold—postharvest and/or processing infection. Mammalian excreta—postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic MARJORAM, GROUND

Insect ﬁlth Average of 1175 or more insect fragments per 10 grams (AOAC 975.49) Rodent ﬁlth Average of 8 or more rodent hairs per 10 grams (AOAC 975.49) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic MARJORAM, UNGROUND

Insect ﬁlth Average of 250 or more insect fragments per 10 grams (AOAC 985.39) Rodent ﬁlth Average of 2 or more rodent hairs per 10 grams (AOAC 985.39) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair—processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

MUSHROOMS, CANNED AND DRIED

Insects (AOAC 967.24)

Average of over 20 or more maggots of any size per 100 grams of drained mushrooms and proportionate liquid or 15 grams of dried mushrooms OR Average of 5 or more maggots 2 mm or longer per 100 grams of drained mushrooms and proportionate liquid or 15 grams of dried mushrooms Average of 75 mites per 100 grams drained mushrooms and proportionate liquid or 15 grams of dried mushrooms Average of more than 10% of mushrooms are decomposed

Mites (AOAC 967.24) Decomposition (MPM-V100) DEFECT SOURCE: Insects—preharvest insect infestation. Mites—preharvest and/or postharvest infestation. Decomposition—preharvest infection SIGNIFICANCE: Aesthetic NECTARS, APRICOT, Mold PEACH AND PEAR DEFECT SOURCE: Preharvest infection SIGNIFICANCE: Aesthetic

Average mold count is 12% or more

NUTMEG, WHOLE

Insect ﬁlth and/or Average of 10% or more pieces by count are insect-infested and/or moldy mold (MPM-V41) DEFECT SOURCE: Insect infestation—preharvest and/or postharvest and/or processing. Mold—preharvest and/or postharvest infection SIGNIFICANCE: Aesthetic. Potential health hazard—may contain mycotoxin producing fungi NUTMEG, GROUND

Insect ﬁlth Average of 100 or more insect fragments per 10 grams (AOAC 979.26) Rodent ﬁlth Average of 1 or more rodent hairs per 10 grams (AOAC 979.26) DEFECT SOURCE: Insect fragments—postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product NUTS, TREE

NUT TYPE Almonds Brazils Cashew Green chestnuts Baked chestnuts Dried chestnuts Filberts Lichee nuts Pecans Pili nuts Pistachios Walnuts

Continued

Defect (Method) Multiple Defects (MPM-V81) UNSHELLED % 5 10 — 15 10 — 10 5 10 15 10 10

Action level Reject nuts (insect-infested, rancid, moldy, gummy, and shriveled or empty shells) as determined by macroscopic examination at or in excess of the following levels:

SHELLED % 5 5 5 — — 5 5 — 5 10 5 5

DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing. Mold—preharvest and/or postharvest and/or processing infection. Gummy & shriveled—preharvest physiological condition, Rancidity—postharvest SIGNIFICANCE: Aesthetic, Potential health hazard—may contain mycotoxin producing fungi OLIVES Pitted olives

Pits (MPM-V67) DEFECT SOURCE: Processing SIGNIFICANCE: Mouth/tooth injury Imported Green olives Insect damage (MPM-V67) DEFECT SOURCE: Preharvest insect infestation SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Average of 1.3 percent or more by count of olives with whole pits and/or pit fragments 2 mm or longer measured in the longest dimension

7% or more olives by count showing damage by olive fruit ﬂy

Salad olives

Pits Average of 1.3 or more olives by count of olives with whole pits and/or pit fragments 2 mm or longer (MPM-V67) measured in the longest dimension Insect damage 9% or more olives by weight showing damage by olive fruit ﬂy (MPM-V67) DEFECT SOURCE: Pits—processing, Insect damage—preharvest insect infestation SIGNIFICANCE: Pits—mouth/tooth injury, Insect damage—Aesthetic Salt-cured olives Insects Average of 10% or more olives by count with 10 or more scale insects each (MPM-V67) Mold Average of 25% or more olives by count are moldy (MPM-V67) DEFECT SOURCE: Scale insects—preharvest infestation. Mold—postharvest and/or processing infection SIGNIFICANCE: Aesthetic Imported Black olives Insect damage 10% or more olives by count showing damage by olive fruit ﬂy (MPM-V67) DEFECT SOURCE: Preharvest insect infestation SIGNIFICANCE: Aesthetic OREGANO, WHOLE PLANT, UNPROCESSED

Insect ﬁlth and/or Average of 5% or more insect infested and/or moldy pieces by weight mold weight (MPM-V32) Mammalian excreta Average of 1 mg or more mammalian excreta per pound (MPM-V32) DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing. Mold—postharvest and/or processing infection. Mammalian excreta—postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic OREGANO, GROUND

Insect ﬁlth Average of 1250 or more insect fragments per 10 grams (AOAC 975.49) Rodent ﬁlth Average of 5 or more rodent hairs per 10 grams (AOAC 975.49) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product

Defect (Method)

Continued Action level

OREGANO, CRUSHED

Insect ﬁlth Average of 300 or more insect fragments per 10 grams (AOAC 969.44) Rodent ﬁlth Average of 2 or more rodent hairs per 10 grams (AOAC 969.44) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic PEACHES, CANNED AND FROZEN

Mold/Insect Average of 3% or more fruit by count are wormy or moldy damage (MPM-V51) Insects In 12 1-pound cans or equivalent, one or more larvae and/or larval fragments whose aggregate length (MPM-V51) exceeds 5 mm DEFECT SOURCE: Mold—preharvest and/or postharvest infection. Insect damage—preharvest insect infestation. Larvae—preharvest insect infestation SIGNIFICANCE: Aesthetic PEANUT BUTTER

Insect ﬁlth Average of 30 or more insect fragments per 100 grams (AOAC 968.35) Rodent ﬁlth Average of 1 or more rodent hairs per 100 grams (AOAC 968.35) Grit Gritty taste and water insoluble inorganic residue is more than 25 mg per 100 grams (AOAC 968.35) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta. Grit—harvest contamination SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

PEANUTS, SHELLED

Multiple defects Average of 5% or more kernels by count are rejects (insect-infested, moldy, rancid, otherwise decom(MPM-V89) posed, and dirty) Insects Average of 20 or more whole insects or equivalent in 100-pound bag siftings (MPM-V89) DEFECT SOURCE: Insect infested—postharvest and/or processing infestation. Moldy—preharvest and/or postharvest and/or processing infection. Rancid & decomposed—postharvest abuse. Dirty—harvest contamination SIGNIFICANCE: Aesthetic, Potential health hazard—may contain mycotoxin producing fungi PEANUTS, UNMultiple defects Average of 10% or more peanuts by count are rejects (insect-infested, moldy, rancid, otherwise decomSHELLED (MPM-V89) posed, and dirty) DEFECT SOURCE: Insect infested—postharvest and/or processing infestation. Mold—preharvest and/or postharvest and/or processing infection. Rancid & decomposed—postharvest abuse SIGNIFICANCE: Aesthetic, Potential health hazard—may contain mycotoxin producing fungi PEAS: BLACK-EYED, Insect damage Average of 10% or more by count of class 6 damage or higher in minimum of 12 subsamples COWPEAS, FIELD (MPM-V104) PEAS, DRIED DEFECT SOURCE: Preharvest and/or postharvest insect infestation SIGNIFICANCE: Aesthetic PEAS, COWPEAS, Insect larvae Average of 5 or more cowpea curculio larvae or the equivalent per No. 2 can BLACK-EYED PEAS (MPM-V104) (SUCCULENT), CANNED DEFECT SOURCE: Preharvest and/or postharvest insect infestation SIGNIFICANCE: Aesthetic PEAS AND BEANS, Insect ﬁlth Average of 5% or more by count insect-infested and/or insect-damaged by storage insects in a miniDRIED (MPM-V104) mum of 12 subsamples DEFECT SOURCE: preharvest and/or postharvest and/or processing infestation SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product

Continued

Defect (Method)

Action level

PEPPER, WHOLE (BLACK & WHITE)

Insect ﬁlth and/or Average of 1% or more pieces by weight are infested and/or moldy insect-mold (MPM-V39) Mammalian excreta Average of 1 mg or more mammalian excreta per pound (MPM-V39) Foreign matter Average of 1% or more pickings and siftings by weight (MPM-V39) DEFECT SOURCE: Insect infested—postharvest and/or processing infestation. Moldy—postharvest and/or processing infection. Mammalian excreta— postharvest and/or processing animal contamination. Foreign material—postharvest contamination SIGNIFICANCE: Aesthetic. Potential health hazard—mammalian excreta may contain salmonella PEPPER, GROUND

Insect ﬁlth Average of 475 or more insect fragments per 50 grams (AOAC 972.40) Rodent ﬁlth Average of 2 or more rodent hairs per 50 grams (AOAC 972.40) DEFECT SOURCE: Insect fragments—postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic PINEAPPLE, CANNED

Mold Average mold count is 20% or more (AOAC 970.75, OR MPM-V73) The mold count of any 1 subsample is 60% or more DEFECT SOURCE: Processing mold contamination SIGNIFICANCE: Aesthetic PINEAPPLE JUICE

Mold (AOAC 970.75)

DEFECT SOURCE: Processing mold contamination SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Average mold count is 15% or more OR The mold count of any 1 subsample is 40% or more

PLUMS, CANNED

Rot Average of 5% or more plums by count with rot spots larger than the area of a circle 12 mm in diam(MPM-V51) eter DEFECT SOURCE: Preharvest and/or postharvest infection SIGNIFICANCE: Aesthetic POPCORN

Rodent ﬁlth (AOAC 950.91)

1 or more rodent excreta pellets are found in 1 or more subsamples, and 1 or more rodent hairs are found in 2 or more other subsamples OR 2 or more rodent hairs per pound and rodent hair is found in 50% or more of the subsamples OR 20 or more gnawed grains per pound and rodent hair is found in 50% or more of the subsamples Field corn 5% or more by weight of ﬁeld corn DEFECT SOURCE: Rodent excreta—postharvest and/or processing animal contamination. Rodent hair—postharvest and/or processing contamination with animal hair or excreta. Rodent gnawing—postharvest and/or processing damage. Field corn—harvest contamination SIGNIFICANCE: Aesthetic POTATO CHIPS

Rot Average of 6% or more pieces by weight contain rot (MPM-V113) DEFECT SOURCE: Preharvest and/or postharvest infection SIGNIFICANCE: Aesthetic PRUNES DRIED AND Multiple defects Average of a minimum of 10 subsamples is 5% or more prunes by count are rejects (insect-infested, DEHYDRATED, (MPM-V53) moldy or decomposed, dirty, and/or otherwise unﬁt) LOW-MOISTURE DEFECT SOURCE: Insect infested—preharvest infestation, Moldy & decomposed—preharvest infection, Dirty—harvest contamination, Otherwise unﬁt— preharvest condition SIGNIFICANCE: Aesthetic PRUNES, PITTED

Pits (MPM-V53)

DEFECT SOURCE: Processing SIGNIFICANCE: Mouth/tooth injury

© 2003 by Marcel Dekker, Inc.

Average of 2% or more by count with whole pits and/or pit fragments 2 mm or longer and 4 or more of 10 subsamples of pitted prunes have 2% or more by count with whole pits and/or pit fragments 2 mm or longer

Commodities and Defect Action Levels Product

Continued

Defect (Method)

Action level

PUREE, APRICOT, Mold Average mold count is 12% or more PEACH AND PEAR (AOAC 982.33) DEFECT SOURCE: preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic RAISINS, NATURAL & GOLDEN

Mold Average of 10 subsamples is 5% or more, by count, moldy raisins (MPM-V76) Sand and Grit Average of 40 mg or more of sand and grit per 100 grams of natural or golden bleached raisins (MPM-V76) DEFECT SOURCE: Mold—postharvest and/or processing infection. Sand—postharvest contamination SIGNIFICANCE: Aesthetic RAISINS, GOLDEN

Insects and insect 10 or more whole or equivalent insects and 35 Drosophila eggs per 8 oz. eggs (AOAC 969.42 & MPM-V76) DEFECT SOURCE: Postharvest and/or processing infestation SIGNIFICANCE: Aesthetic SAGE, WHOLE PLANT, UNPROCESSED

Insect ﬁlth Average of 5% or more pieces by weight are insect infested (MPM-V32) Mammalian excreta Average of 1 mg or more per pound after processing (MPM-V32) DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing infestation. Mammalian excreta—postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

SAGE, GROUND

Insect ﬁlth Average of 200 or more insect fragments per 10 grams (AOAC 985.38) Rodent ﬁlth Average of 9 or more rodent hairs per 10 grams (AOAC 985.38) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic SALMON, CANNED

Decomposition

2 or more Class 3 defective cans, regardless of lot or container size OR 2 to 30 Class 2 and/or Class 3 defective cans as required by sampling plan based on lot size and container size NOTE: A defective can is deﬁned as one that contains Class 2 or Class 3 decomposition—see FISH product listing. Sampling plan tables are available on request from FDA DEFECT SOURCE: Postharvest and/or processing temperature abuse SIGNIFICANCE: Potential health hazard from decomposition metabolites SAUERKRAUT

Insects (AOAC 955.45) DEFECT SOURCE: Preharvest insect infestation SIGNIFICANCE: Aesthetic SESAME SEEDS

Average of more than 50 thrips per 100 grams

Insect ﬁlth Average of 5% or more seeds by weight are insect-infested or damaged (MPM-V32) Mold Average of 5% or more seeds by weight are decomposed (MPM-V32) Mammalian excreta Average of 5 mg or more mammalian excreta per found (MPM-V32) Foreign matter Average of 0.5% or more foreign matter by weight (MPM-V32) DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing infestation. Mold—preharvest infection. Mammalian excreta—postharvest and/or processing animal contamination. Foreign matter—post processing and/or processing contamination SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product SHRIMP: UNPROCESSED, FRESH (OR) FROZEN

Defect (Method) Decomposition

Continued Action level 5% or more are Class 3 or 20% or more are Class 2 decomposed as determined by organoleptic examination in 2 or more subsamples OR If percentage of Class 2 shrimp plus 4 times percent of Class 3 equals or exceeds 20% in 2 or more subsamples

Indole levels of 25 µg/100 gm to 49 µg/100 gm for both original and check analysis conﬁrm Class 2 decomposition; levels equal or greater than 50 µg/100 gm conﬁrm Class 3 decomposition. The absence of indole, however, does not prove the absence of decomposition. DEFECT SOURCE: Postharvest and/or processing temperature abuse SIGNIFICANCE: Potential health hazard from decomposition metabolites SHRIMP: PROCESSED, COOKED (OR) FROZEN, (CANNED)

Decomposition

2 or more subsamples classiﬁed as decomposed Subsamples are classiﬁed by organoleptic examination as Acceptable (Passed) or decomposed (Failed) based on the presence or absence of odors of decomposition.

Subsamples may also be classiﬁed as decomposed if they contain indole equal or greater than 25 µg/ 100 gm. for both original and check analysis DEFECT SOURCE: Postharvest and/or processing temperature abuse SIGNIFICANCE: Potential health hazard from decomposition metabolites SPICES, LEAFY, OTHER THAN BAY LEAVES

Insect ﬁlth and/or Average of 5% or more pieces by weight are insect-infested and/or moldy mold (MPM-V32) Mammalian excreta Average of 1 mg or more of Mammalian excreta per pound after processing (MPM-V32) DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing infestation. Mold—preharvest and/or postharvest and/or processing infection. Mammalian excreta—postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

SPINACH, CANNED OR FROZEN

Insects and mites (AOAC 974.33)

Average of 50 or more aphids, thrips and/or mites per 100 grams OR 2 or more 3 mm or longer larvae and/or larval fragments or spinach worms (caterpillars) whose aggregate length exceeds 12 mm are present in 24 pounds OR Leaf miners of any size average 8 or more per 100 grams or leaf miners 3 mm or longer average 4 or more per 100 grams

DEFECT SOURCE: Preharvest infestation SIGNIFICANCE: Aesthetic STRAWBERRIES: FROZEN WHOLE OR SLICED

Mold (AOAC 952.22)

Average mold count of 45% or more and mold count of at least half of the subsamples is 55% or more

Grit Berries taste gritty DEFECT SOURCE: Mold—postharvest and/or processing infection. Grit—harvest contamination SIGNIFICANCE: Aesthetic THYME, WHOLE PLANT, UNPROCESSED

Insect ﬁlth (MPM-V32)

Average of 5% or more pieces by weight are insect infested and/or moldy

Mammalian excreta Average of 1 mg or more mammalian excreta per pound after processing (MPM-V32) DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing infestation. Mold—preharvest and/or postharvest and/or processing infection. Mammalian excreta—postharvest and/or processing animal contamination SIGNIFICANCE: Aesthetic THYME, GROUND

Insect ﬁlth Average of 925 or more insect fragments per 10 grams (AOAC 975.49) Rodent ﬁlth Average of 2 or more rodent hairs per 10 grams (AOAC 975.49) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing infestation Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product

Defect (Method)

Continued Action level

THYME, UNGROUND, PROCESSED

Insect ﬁlth Average of 325 insect fragments or more per 10 grams (AOAC 975.49) Rodent ﬁlth Average of 2 rodent hairs or more per 10 grams (AOAC 975.49) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation, Rodent hair—postharvest and/or processing contamination with animal hair or excreta SIGNIFICANCE: Aesthetic TOMATOES, CANNED

Drosophila ﬂy (AOAC 955.46)

Average of 10 or more ﬂy eggs per 500 grams OR 5 or more ﬂy eggs and 1 or more maggots per 500 grams OR 2 or more maggots per 500 grams DEFECT SOURCE: Preharvest and/or postharvest and/or processing insect infestation SIGNIFICANCE: Aesthetic TOMATOES, CANNED, Mold Average mold count in 6 subsamples is 15% or more and the counts of all of the subsamples are more WITH (OR) WITH(AOAC 945.90) than 12% OUT JUICE (BASED ON DRAINED JUICE) DEFECT SOURCE: Preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic TOMATOES, CANNED Mold Average mold count in 6 subsamples is 29% or more and the counts of all of the subsamples are more PACKED IN TO(AOAC 945.90) than 25% MATO PUREE (BASED ON DRAINED LIQUID) DEFECT SOURCE: Preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

TOMATO JUICE

Drosophila ﬂy (AOAC 955.46)

Average of 10 or more ﬂy eggs per 100 grams OR 5 or more ﬂy eggs and 1 or more maggots per 100 grams OR 2 or more maggots per 100 grams, in a minimum of 12 subsamples Mold Average mold count in 6 subsamples is 24% or more and the counts of all of the subsamples are more (AOAC 965.41) than 20% DEFECT SOURCE: Fly eggs & maggots—preharvest and/or postharvest and/or processing insect infestation. Mold—preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic TOMATO PASTE, PIZZA AND OTHER SAUCES

Drosophila ﬂy (AOAC 955.46)

TOMATO PUREE

Drosophila ﬂy (AOAC 955.46)

Average of 30 or more ﬂy eggs per 100 grams OR 15 or more ﬂy eggs and 1 or more maggots per 100 grams OR 2 or more maggots per 100 grams in a minimum of 12 subsamples DEFECT SOURCE: Preharvest and/or postharvest and/or processing insect infestation SIGNIFICANCE: Aesthetic Average of 20 or more ﬂy eggs per 100 grams OR 10 or more ﬂy eggs and 1 or more maggots per 100 grams OR 2 or more maggots per 100 grams in a minimum of 12 subsamples DEFECT SOURCE: Preharvest and/or postharvest and/or processing insect infestation SIGNIFICANCE: Aesthetic TOMATO PASTE (OR) Mold Average mold count in 6 subsamples is 45% or more and the mold counts of all of the subsamples are PUREE (AOAC 955.46) more than 40% DEFECT SOURCE: Preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

Commodities and Defect Action Levels Product

Defect (Method)

Continued Action level

PIZZA AND OTHER TO- Mold Average mold count in 6 subsamples is 34% or more and the counts of all of the subsamples are more MATO SAUCES (AOAC 945.92) than 30% DEFECT SOURCE: Preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic TOMATO SAUCE, UNMold Average mold count in 6 subsamples is 45% or more and the mold counts of all of the subsamples are DILUTED (AOAC 965.41) more than 40% DEFECT SOURCE: Preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic TOMATO CATSUP

Mold Average mold count in 6 subsamples is 55% or more (AOAC 965.41) DEFECT SOURCE: Preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic TOMATO POWDER, Mold Average mold count in 6 subsamples is 45% or more and the mold counts of all of the subsamples are EXCEPT SPRAY(AOAC 972.42) mold than 40% DRIED DEFECT SOURCE: Preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic TOMATO POWDER, Mold Average mold count in 6 subsamples is 67% or more SPRAY-DRIED (AOAC 972.42) DEFECT SOURCE: Preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic TOMATO SOUP AND Mold Average mold count in 6 subsamples is 45% or more and the mold counts of all of the subsamples are TOMATO PROD(AOAC 945.91) more than 40% UCTS DEFECT SOURCE: Preharvest and/or postharvest and/or processing infection SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.

TUNA, CANNED

Decomposition (AOAC 957.07, 977.13)

Odors of decomposition OR honey-combed tissue OR histamine equal to or greater than 5 mg/100 gm in 2 or more cans DEFECT SOURCE: Postharvest and/or processing temperature abuse SIGNIFICANCE: Potential health hazard from decomposition metabolites TUNA, FRESH, FROZEN

Decomposition Odors of decomposition (AOAC 957.07, OR 977.13) histamine equal to or greater than 5 mg/100 gm DEFECT SOURCE: Postharvest and/or processing temperature abuse. SIGNIFICANCE: Potential health hazard from decomposition metabolites WHEAT

Insect damage Average of 32 or more insect-damaged kernels per 100 grams (MPM-V15) Rodent ﬁlth Average of 9 mg or more rodent excreta pellets and/or pellet fragments per kilogram (MPM-V15) DEFECT SOURCE: Insect damage—preharvest and/or postharvest and/or processing infestation. Excreta—postharvest and/or processing animal contamination. SIGNIFICANCE: Aesthetic WHEAT FLOUR

Insect ﬁlth Average of 75 or more insect fragments per 50 grams (AOAC 972.32) Rodent ﬁlth Average of 1 or more rodent hairs per 50 grams (AOAC 972.32) DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with animal hair or excreta. SIGNIFICANCE: Aesthetic

© 2003 by Marcel Dekker, Inc.