Beyond Limits?: Dealing with Chemical Risks at Work in Europe

LIMITS? BEYOND LIMITS? DEALING WITH CHEMICAL RISKS AT WORK IN EUROPE

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LIMITS? BEYOND LIMITS? DEALING WITH CHEMICAL RISKS EUROPE AT WORK IN EUROPE

By DAVID WALTERS KAROLA GRODZKI

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Acknowledgements The research that went into writing this book was made possible by funding from two separate sources. First, the UK Health and Safety Executive supported a study into systems and practices for setting and using occupational exposure limits in selected EU countries. Second, the Long-range Research Initiative (LRI) of the European Chemical Industry Council (CEFIC) funded an on-going study focused on the management of chemical risks in smaller enterprises in several EU countries. Material from both these studies has been used in the completion of the present volume. The authors are grateful for the assistance of numerous individuals, from both organisations that have been helpful throughout the research and writing of the book. We would especially like to thank members of the HSC Advisory Committee on Toxic Substances, Judy Caute, Carole Sullivan and Michael Topping of the HSE and Chris Money of CEFIC and the LRI. In preparing this book we have also been reliant on the aid of a substantial number of persons in each country in which our investigations have been undertaken. Representatives of trade unions, labour inspectorates, health and safety policy makers, employers' organisations, researchers and observers were not only willing subjects for interview but often played a key role establishing further contacts with important informants in each country. Although these people are too numerous to mention by name, the authors would like to acknowledge their debt to their active co-operation and help. Without it, this book would not have been possible. In addition, we would like especially to thank Ann-Beth Antonsson, Kaj Flick, Mat Jongen, Alex Karageorgiou, Gtinther Kittel, Jan Popma, Andrea Tozzi, Remco Visser, Janneke Waage, Kerstin Wahlberg and Henning Wriedt for facilitating contacts in the countries of the study and for helping with the content of the country chapters, Martin Axon and Ian Bartlett both formerly of South Bank University for assisting with organising the early part of the work and for stimulating discussion on the scientific/technical aspects of the subject. Hazel Slavirt and Nick Bailey provided additional editorial support and last but by no means least we are especially grateful to Sandra Bonney for her help in preparing the final version of the book and for working on the Index, While acknowledging the help of all these sources, the responsibility for the content and views expressed in the following pages and any inaccuracies or misrepresentations therein remains that of the authors.

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vii

TABLE OF CONTENTS INTRODUCTION: HAZARDS, RISKS AND LIMITS

1

2

1

Hazardous Substances - A Defining Concern of Occupational Health and Safety Why Focus on OELs? The Countries The Structure of the Book

2 5 9 11

THE PROBLEM OF CHEMICAL RISKS

13

Introduction Chemicals at Work in the EU Mortality, Morbidity and Occupational Exposure to Hazardous Substances in Europe Issues for the Role of OELs in Managing Work With Chemical Risks What are Occupational Exposure Limits and How Have They Developed? The Meaning and Use of Exposure limits New Directions in Regulating Risk Management of Hazardous Substances and the Role of OELs Conclusions: But What About Using OELs?

13 13

EXPOSURE LIMITS AND INSTITUTIONAL STRUCTURES FOR HAZARDOUS SUBSTANCE REGULATION IN THE EUROPEAN UNION , Introduction EU Legislative Frameworks for Minimising Health and Safety Risks of Dangerous Substances Requirements Regulating Chemical Risks Generally in the EU European Legislation With A Special Focus On Protecting Workers from the Risks Arising from Hazardous Chemicals OEL Setting at the European Level Effectiveness of the Existing Legislation and the Future Approach at Community Level

15 19 21 25 30 35

37 37 38 40 47 53 56

viii Beyond Limits

REACH and Worker Protection Conclusion

60 62

SYSTEMS FOR SETTING AND USING OCCUPATIONAL EXPOSURE LIMITS IN EU 15 COUNTRIES

65

Introduction Regulatory Systems and Responsible Bodies Implementing EU Requirements in EU 15 Member States Occupational Exposure Limit Values in the EU 15 Countries Procedures for Setting OELs Enforcement and Surveillance of Compliance with OELs in EU 15 Countries Austria Belgium Denmark Finland France Germany Greece Ireland , Italy Luxembourg Portugal Spain Sweden The Netherlands United Kingdom Conclusions

94 94 95 96 97 99 102 103 104 105 106 107 108 109 110 Ill 112

THE UNITED KINGDOM

119

,

,

Introduction Background: Legislative Reforms from the 1970s Regulating Risk Management of Hazardous Chemicals Using OELs at the Workplace New Approaches to Chemical Controls: A New Role for OELs? OELs and COSHH Essentials in Practice

65 67 72 73 84

119 120 123 135 147 152

Table of Contents ix

Summary of WEL Setting Procedures (After HSC 2003)

159

Conclusions: Applying the New Framework in Practice

161

GERMANY

171

,

Introduction The Background The Extent of the Problem of Chemical Exposure in Germany Regulating Chemical Risks - The Germany Health and Safety System in Outline The Legislative Framework for OELs Wood Dust Toluene Discussion: The role of OELs in Monitoring Compliance with Requirements to Manage the Use of Chemicals Safely GREECE Introduction The Regulatory Infrastructure Setting Exposure Limits The Role of OELs in Achieving Compliance - in Theory The Role of OELs in Regulating the Management of Risk in Practice Challenges for Regulating the Management of Chemical Risks in Greece Enhancing Competence in Relation to Hazardous Substances Qualifications of Safety Engineer Sector Specific Experience of Wood Dust and Toluene Conclusions: The Limited Role of OELs in Controlling Risks of Hazardous Chemicals in the Workplace

171 173 173 175 182 193 205 217 227 227 229 233 235 237 240 241 244 245 254

ITALY

261

Introduction , The Italian Model for Regulating Health and Safety at Work Legislative Background , Measures Regulating Chemical Risks Application in Practice

261 264 265 268 276

x Beyond Limits

8

9

10

Conclusions

286

THE NETHERLANDS

289

Introduction

289

The Infrastructure and Processes Involved in Setting OELs Political and Legislative Contexts Operating the Dutch Approach to OELs , Conclusions

291 296 303 315

SWEDEN

319

Introduction The Use of Chemical Substances at Work in Sweden Economic and Legislative Background The Swedish Approach to Regulating the Work Environment Setting OELs Achieving Compliance with OELs Conclusions

319 320 321 322 324 327 335

BEYOND LIMITS?-THE PLACE OF OELs IN THE NEW REGULATION OF CHEMICAL RISKS IN EUROPE

341

Introduction What are OELs for? The Changing Role of OELs in Regulatory Approaches to Achieving Chemical Risk Management The Way Forward?

341 343 .347 357

REFERENCES

367

INDEX

407

xi LIST OF FIGURES Figure 4.1 Figure 4.2 Figure 4.3 Figure 4.4 Figure 5.1 Figure 5.2 Figure 5.3 Figure 6.1

HSE'sTolerabilityofRisk Framework and OELs Setting OELs in the UK (after Topping 2001) Mechanism of actions involving OELs Summary ofWEL setting procedures (after HSC 2003) The German OHS system Aggregated data for Toluene Exposure measurements of Toluene Number of inspection visits and sanctions distributed by economic activity

131 133 144 159 179 210 211 239

xii

LIST OF TABLES Table 3.1 National institutions with responsibilities for developing occupational exposure limits and with their surveillance. 68 Table 3.2 Some common features of OEL terminology in EU 15 country lists 76 Table 3,3 Summary of procedures for setting OELs in EU 15 countries 84 Table 5.1 Number of businesses in woodworking and furniture 196 Table 5.2 Number of employees in woodworking and furniture 196 Table 6.1 Number of inspection visits 238 Table 6.2 Number of sanctions 238 Table 6.3 Qualification Requirements for Safety Engineers According to the Risk Classification of Enterprises 244

xiii LIST OF ANNEXES

Annex 1 Websites of Ministries and other bodies involved in Health and Safety

379

Annex 2 Transposition of Main European Chemical Legislation (workers protection against hazardous chemicals)

386

Annex 3 Source of legislative provisions and occupational exposure level lists

388

Annex 4 National Institutions responsible for setting OELs.

398

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1

INTRODUCTION: HAZARDS, RISKS AND LIMITS This book is a study of strategic approaches to managing the risks of working with hazardous substances in the European Union. Its central theme addresses developments at national and international levels concerning safety in the use of chemical substances at work. Its primary focus is the role of occupational exposure limits (OELs) in these developments and their translation - again with particular reference to OELs - into practices within workplaces and especially within the small and medium sized workplaces that constitute the vast majority of establishments in which people work in Europe. It sets out to answer two linked questions -

What drives informed and competent risk management in chemical health and safety? What is the role (if any) of OELs in this process?

In seeking the answers to these questions and contextualising them within wider approaches to occupational health and safety (OHS) management in Europe, the book explores the challenges hazardous substances pose for effective OHS management. It grew out of a research project commissioned by the Health and Safety Commission (HSC) Advisory Committee on Toxic Substances (ACTS) in the UK in 2002.1 The aim of that project was to inform discussion of reform of the UK system for setting occupational exposure limits (OELs) by providing information on systems adopted for this purpose in other EU countries and on how such OELs are used in practice at workplaces in these countries. The contents of the present volume represent a considerable development of these aims. They encompass an overview of the legislative frameworks and responsible bodies involved in setting OELs at EU level and in all EU 15 countries and a detailed study of policy and practice in the use of OELs in risk management of hazardous substances at national, sectoral and workplace levels in six of these countries. Based on this material, they further include the identification and analysis of the issues confronting strategic approaches to regulating risk management of

The full report of this research project is available from HSE Books. See Walters et al (2003).

2 Beyond Limits

hazardous substances, ways in which they are addressed at EU level and in the countries that are the focus of the study. Nevertheless the research that was undertaken for the ACTS study remains the basis for much of the empirical material included here. It has been updated and further developed since it was originally collected in 2002/3 and also includes additional material derived from a current study funded by the European Chemical Industry Council (CEFIC)2 concerned with approaches to risk management of hazardous substances in small enterprises across most of the same range of European countries covered by the original project. As we explore in Chapter 2, the subject is particularly topical in the light of current strategies on chemical risks at EU level. Although the focus of the book is on the EU 15 countries,3 the recent expansion of the Community to include a range of new member states with reconstituted health and safety systems that are considerably younger and less sophisticated than those presently found in northern European member states, makes its findings especially timely in relation to these countries too.

HAZARDOUS SUBSTANCES—A DEFINING CONCERN OF OCCUPATIONAL HEALTH AND SAFETY. For most people, the effects of exposure to hazardous substances are prominent amongst risks that they commonly associate with the work environment. From earliest times, ill effects of work on health have been linked with exposure to chemical substances in their various physical forms and especially to airborne chemicals in the form of dusts, fumes and gases. These associations, the need to find out more about them, and to avoid or control their effects, have been fundamental to the growth of the subject of occupational health and safety as a research and professional concern, to the role of regulation in the work environment and to both the development of organised labour and its health and safety strategies. There are historical inter-relationships between these various elements that have helped to define the way in which professional, regulatory and interest group approaches to the broad subject of health and safety has developed over the last two

This research project titled, 'A Review of Workplace Management Strategies for Chemicals in Small Enterprises" is funded by the CEFIC Long Range Research Initiative (LRI). It will be completed by mid-2006 and will be the subject of further publications. That is, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden and the United Kingdom.

Introduction 3 centuries in market economies. Central to them has been concern about hazardous substances. A further dimension of the role of hazardous substances in health and safety is the part they have played in the development of attitudes and awareness of risk and risk regulation in wider society. Interlinked with occupational concerns but encompassing both consumer and environmental interests, public concern about hazardous substances in the economy is now deeply engrained in civil society and has wide-reaching political, economic and regulatory dimensions embracing for example, the governance of risk from hazardous installations, consumer safety, and environmental contamination as well as healih and safety at work. The unchecked activity of chemical polluters and the effects of their pollution were amongst the formative concerns of environmental movements internationally from the late 1960s. They remain central to the concerns of both these social interest groups and the wider public. Parenthetically, the development of much of the ideas behind modern radical support for the reform of health and safety regulation has its roots in the same formative issues. Linked to them are also the changes that have taken place in public awareness of the role of government, industry and the scientific establishment in addressing the regulation of the risks of hazardous substances. Perceived failures in exercising such control effectively account to no small extent for the current low levels of public trust in these actors and their policies. At the same time, policy makers and regulators at sectoral, national and international levels, as well as interest groups that are engaged with policy and regulation at these levels, have all struggled to effect strategies for safe use of hazardous substances at work that are both rigorous and transparent. The current frameworks for setting OELs and the thinking behind them in different EU countries and at EU level are themselves products of such efforts. This is in part because although there is substantial concern about the hazardous nature of many substances that are used at work, it is equally self-evident that the economic worth of producing and using such substances and their value to society dictates their continuing and even increasing presence in the workplace. As a consequence, the risks of working with them, as well as the need to better understand and control their use, have been a primary focus for the scientific and engineering basis of monitoring and controlling the working environment that has guided the emergence of professional disciplines such as those of occupational hygiene, elements of safety engineering and occupational medicine, toxicology and related fields during their development over the past century and a half. In post-industrialised market economies organised labour has evolved strategic positions on achieving the regulation and control of the risks of

4 Beyond Limits hazardous substances that are themselves deeply rooted in the experiences of labour including the suffering of victims and their families - and which are not so much aimed at contributing to the science, engineering and technology of safe chemical usage as they are at ensuring the representation of the views and experiences of those affected by chemical hazards. At the same time, in most social democracies the structures and processes for regulating occupational risks share some common ground in as much as there is a place within them for social dialogue. Since the 1970s tripartitism in decision making on regulating health and safety has been increasingly the pattern in most EU member states and at European level reflecting, amongst other things, the orientation of regulatory provisions towards the processes of managing health and safety in which the participation of workers is seen as central to successful health and safety management. Representatives of industry and labour and their advisers therefore meet together with those of the state to decide on ways in which improvements are to be achieved in regulating occupational risks. The structures and procedures for setting OELs and deciding their regulatory status are constituted along these lines in most EU countries. In such forums issues of cost and practicability are central to decisions about control and this is as true for the regulation of the risks of hazardous substances as it is for health and safety matters generally. In these forums therefore, as well as organised labour the role of capital is a significant presence and both the chemical industry itself and representatives of employers that use chemicals provide a powerful lobby advocating the benefits of chemical substances they produce and use. In all of this an approach to safeguarding workers' health and safety has emerged where the moral high ground has been dominated by precautionary principles of control in which essentially ethical considerations demand a preferred sequence for the selection of appropriate controls to ensure maximum safety in the use of hazardous substances and where safety should not be assumed in the absence of proven risk. Within the hierarchy of control thus envisaged, for example removal of the risk of harm through substitution of unsafe substances with a safe one, is preferable to controlling the use of the substance though physical containment to prevent human contact. This in turn is preferred to minimising the risk of human contact with airborne contamination through provision of exhaust ventilation at source, itself a strategy that is seen as preferable to minimising human contact by behavioural controls for workers and the provision of protective equipment. Juxtaposed with such ethics are the essentially economic considerations behind the use to which the hazardous substance is being put and their value to wider society, as well as the economic and technical feasibility of the

Introduction 5

introduction of suitable health and safety control. Thus compromise situations result in which notions of managing risk to acceptable or tolerable levels are pursued within whichever value system is operational in the social, legal, political and economic context of the society and time in question.

WHY FOCUS ON OELS? Achieving such controls requires good quality information concerning the properties and known health effects of exposure to substances, as well as on the technical issues of achieving appropriate environmental control, in order that the feasibility of introducing particular control measures can be weighed against the consequences of exposure. Ideally, since the toxicity of a particular substance is usually dependent on a combination of its (toxic) properties and the quantity (dose) to which the subject is exposed, it should be possible to protect the health of workers by determining levels of exposure below which the risks to health are reduced to negligible levels. The idea of exposure limits for hazardous substances in workplace health and safety developed from this. First proposed by individuals in the late 19th century, subsequently developed into nationally applicable lists in the first half of the 20th century and most conspicuously represented by the American Conference of Governmental Industrial Hygienists' (ACGIH) list of Threshold Limit Values (TLVs) that originally dated from 1946, as we discuss in Chapter 1, OELs became prominent in professional approaches to monitoring and controlling occupational exposures during the second half of the 20* century.4 Indeed, it could be argued that especially in North America and the UK, their understanding and use played a significant role in the development of the occupational hygiene profession.5 Although originally conceived as technical standards to be used as guidance for professional occupational hygienists, within in the EU such limits became increasingly incorporated into regulatory systems at national and EU level from the 1980s onwards. It is probable that there was a mixture of drivers behind this development. They would

According to Cook (1985 and 1987) the first 'official' list of OELs was issued by the USSR Ministry of Labour in 1930. See Piney (1989 and 1998) for a more detailed account of the interrelationship between the role of early OELs and the development of the occupational/industrial hygiene profession in the US and UK during the first half of the 10b century.

Limits 6 Beyond Limits have included the more structured and systematic approaches to regulating OHS management that began to emerge at national and European Community level during the 1980s, culminating in the Framework Directive 89/391 its daughter directives and the national measures that transpose them (Walters, 2002:41-47). Parallel approaches in relation to managing the risks of hazardous substances were emerging at national level (for example, the COSHH Regulations in the UK) and at EU level (such as the Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens and the Directive 98/24 on the protection of workers from the risks related to chemical agents at work). The demand for standards to control the use of a number of specific and highly toxic substances such as vinyl chloride, asbestos, benzene and lead in combination with the drive towards systematic management of OHS generally may have also fuelled the perceived need for greater systematicity in the regulation of the management of occupational exposure to hazardous substances. This may in turn have created pressure for a more developed regulatory role for OELs. At the same time that a number of European countries were setting up national bodies to set their own OELs instead of adopting the American list of TLVs produced by the ACGIH, European Community level institutions such as the Scientific Committee on Occupational Exposure Limits (SCOEL) were created with the intention to contribute to the process of setting OELs at EU level. The Chemical Agents Directive 98/24 and the Indicative Occupational Exposure Limit Value (IOELV) Directive made under it continued the institutionalisation of OELs within the legislative process, adding an international dimension to the pressure to incorporate OELs into regulatory systems. Incorporation of OELs into these systems however was not inevitable. It would seem that the decision making bodies internationally within Europe were desirous of adopting 'good occupational hygiene practice' in giving some regulatory significance to establishing the hierarchy of control practices referred to previously. Since OELs were fundamentally reference standards that were used by hygienists in exposure measurement they too would become part of the package of 'good occupational hygiene practice* that was being incorporated into regulatory systems. Additionally their incorporation seems also to have been driven by a desire to use numerical values to make judgements about risk and to guide practice in ways that may in hindsight appear, if not ill-considered, then at very least to underestimate the problems for risk communication that would be created by the need for a proper understanding of the meaning of such values.

Introduction 7 Somewhat paradoxically, by the time these developments were underway and 'good occupational hygiene practice* was achieving a level of regulatory incorporation that included a place for OELs, hygienists themselves were beginning seriously to question their value, as it was becoming more widespread knowledge that OELs were not without their limitations. As Hanson (1998:12) has observed, for a host of good reasons, there is in fact no reliable scientific basis for drawing a fine line between hazardous and non-hazardous concentrations of a toxic substance. Understanding the scientific meaning of an OEL and most importantly, its reliability as a measure of risk is therefore fundamental to its proper use. As we explore a little further in the following chapter, such an understanding requires a reasonably sophisticated appreciation of the scientific limitations of both the methodology for deriving OELs and the evidence on which they are based. In addition, as the prominence of OELs has increased, critics have pointed to serious shortcomings in both these fundamental elements in the derivation of such limits and the assumptions surrounding them, especially in relation to the most influential and widely used American ACGIH list of TLVs.6 The significance of these limitations of course becomes considerably more serious when they are incorporated into regulatory systems and this no doubt helped focus attention on them. In addition, a further set of doubts were growing, at least in some countries, concerning the practical use of OELs at the level of the workplace. To an extent these practical concerns were related to the complexities involved in understanding the meaning of OELs and thereby being able to use them in an informed and appropriate manner. However, they were also based on evidence emerging in the UK for example which indicated that despite them being quite central to the prevention principles that were the basis of regulatory measures such as the Control of Substances Hazardous to Health Regulations - they were in fact little understood by the majority of employers who were duty holders under the Regulations and required to implement their measures (HSE 1997). These developments and the debates that surround them were largely the reasons for undertaking the research project on which the following chapters are based. They raise some fundamental questions about the way in which OELs are understood by employers and workers and the use to which they are put in the practice of managing risks from Articles in the scientific literature in the late 1980s and early 1990s questioned the completeness of the evidence on which they were based and also pointed to corporate bias in the standard setting bias of the committee (Casteleman and Ziem 1988). See also Ziem and Castleman (1989) and Roach and Rappaport (1990).

Limits 8 Beyond Limits hazardous substances in European workplaces. Equally, they have implications for strategic decisions taken at national and sectoral levels about the role of OELs in regulating these practices. We explore these issues and assess their implications. There are indications of recent shifts in the function of OELs in regulatory strategies in some EU countries. We also examine the extent to which these changes reflect awareness of the possible limitations of the role of OELs in previous strategies and therefore represent more informed approaches. Fundamental to our approach, is the idea that such change cannot be understood in isolation from other aspects of regulating health and safety management in the EU. They are an integral part of this wider scenario and therefore affected by the pressures and constraints that have an impact upon it. The essential elements of current regulatory strategies aimed at the work environment in the EU - with their focus on employers' responsibilities for systematic OHS management through the adoption preventive principles in which risk evaluation and control in their workplaces are undertaken with the support, if necessary, of prevention services and through informing and consulting workers and their representatives - apply as much to managing the risks of hazardous substances as they do to all other aspects the work environment. Moreover, the same challenges to regulating the work environment in the modem world of work apply to hazardous substances as they do to regulating health and safety more generally. Any significant understanding of the strengths and weaknesses of role of OELs in managing health and safety regulation must be one that accounts for a world of work in which for example, a large proportion of work takes place in small enterprises where there is low trade union density and poor access to prevention services, as well as a very low likelihood of experiencing any proactive regulatory inspection visits. Such 'hard to reach' situations are by no means confined to small enterprises but are also found in what were formerly large organisations where the structure of work has become increasingly fragmented and where outsourcing, casualisation and the use of contractors and contractor labour on multi-employer worksites, all contribute challenges to the systematicity and penetration of management arrangements, especially where issues of information, communication and supervision are concerned. Arguably the relevance of approaches to using OELs in strategies to regulate the management of the risks of hazardous substances must account for the realities of the experiences of the most vulnerable workers in these situations if they are to be deemed to be effective. Relatedly, they need to take account of the levels of resourcing of regulatory inspection, the extent of effective worker consultation and representation, the presence and competence of prevention services in health and safety and the levels of use employers

Introduction 9 make of such services in supporting their approaches to managing the risks of hazardous substances in their workplaces. These are issues that we will examine in further detail in the chapters that deal with the approaches to setting and using OELs in the six countries that were the focus for detailed investigation. Our choice of these countries was based on several criteria as we outline in the following section.

THE COUNTRIES Resource constraints meant we could not study in detail all 15 countries that were member states of the EU at the time the fieldwork was undertaken. Countries were therefore selected on the basis of them providing a variety of national situations that reflected the full range of approaches used in relation to setting and using OELs - from highly developed OEL systems to minimal ones and therefore the range of different frameworks for the setting and use of OELs identified across all EU 15 countries. Our choice was also intended to be representative of the range of regulatory and socioeconomic systems in these countries and reflect some consideration of the size, complexity and economic importance of the countries. We selected: -

The UK - as the "benchmark' country in which there is a well-documented role for OELs within the regulatory system that has been subject to considerable and on-going reform in the light of experience. It is also a country in which the wider regulatory system for OHS reflects a particular approach to process regulation as well as to the use of more multidimensional approaches to regulatory intervention and one in which the strategy for reaching small enterprises is clearly articulated.

-

Sweden - as a representative Nordic country with advanced regulatory provisions for OHS and a long involvement in setting and using national OELs.

-

The Netherlands - because of the innovative approaches that appear to be in use in relation both to managing chemical risks and in OHS more widely. Also because in many respects it represents a hybrid of Nordic and Germanic approaches to labour relations and to regulating OHS (as well as being influenced by British pragmatism and the recommendations of the Robens Committee).

10 Beyond him its 10 Limits -

Germany - because of its size, economic importance and complexity, its dual system for OHS regulation, its approach to labour relations and its long history of setting and using exposure limits,

-

Italy - because it is a large and economically important southern European country with some unique regulatory features in its OHS system with interesting differences in approach to that of northern Europe. It also had a traditional approach to exposure standards that was different to that required under the Chemical Agents Directive.

-

Greece - as an example of a smaller and economically weaker southern European country with underdeveloped systems for the wider regulation of OHS as well as for setting and using OELs.

In each country we undertook to identify and review available literature, focusing on: -

-

issues in securing improved management of chemical health and safety, including: - perceptions of the problem - risk assessment - employer/worker awareness - securing compliance with OELs the status of controls for airborne exposures in each country degree to which such controls are applied measures used to achieve and monitor compliance and the extent of compliance itself.

It was anticipated that the literature would be rather limited in most countries and would not deal directly with many of these issues. This was indeed the case and other sources of information were sought including a number of key informants in each country. These informants were a mixture of regulatory agency personnel, trade union officials, industry spokespersons and specialist researchers/professionals, all of whom were considered to be well informed and well placed to comment on the realities of workplace practices. Their views were compared with documented policy as well as with existing literature on the issues under investigation in order to enhance and develop

Introduction 11

the picture of national practice. Specific information was sought from interviews concerning:7 -

theroleofOELs in determining what control measures were in use in OHS management at the workplace the extent to which reference was made to OELs in monitoring OHS management by the labour inspectorate what other measures were used in addition to or instead of OELs to determine control measures and good OHS management practice.

THE STRUCTURE OF THE BOOK Chapter 1 presents a brief overview of current understanding of occupational exposure to hazardous substances and its effects in terms of mortality and morbidity amongst workers. The role of chemicals in the economy and the extent of their production and use in the European Union are outlined before a discussion of the relevant key approaches to regulating health and safety health and safety management of hazardous substances in the European Union is presented. Since the book is concerned with their role in regulation, specific aspects of what OELs are and how they have developed and some key issues in understanding their meaning and appropriate use are explored. Their positions in current strategies to regulate chemical risk at European and national levels are outlined. Current issues for the use of OELs in the regulation of chemical risks emerge as a result and the chapter concludes with a discussion of their implications that sets the scene for the chapters that follow. In the original study on which this book is based, two substances were chosen for the main focus of the country studies. They were toluene and wood-dust, for which, all EU member states have exposure limits. It was intended that attention would be paid especially to sectors in which there was relevant experience of exposure to these substances and in which a reasonable range of workplace size, work processes and health and safety risks were represented. The main sectors where we thought it most likely we would find such things were the furniture industry, printing and metal manufacture. In practice, we found it necessary not to restrict the study to experiences associated only with these substances and sectors to explain and understand national approaches and a more general view of practice in relation to OELs was in feet sought. The present volume reflects this experience, however, some of the detailed examples of practices in relation to these two substances in the sectors mentioned have been retained.

12 Beyond him its 12 Limits

Chapter 2 is concerned the structures and procedures for setting and applying OELs at European level. It opens with a description of the development of the relevant EU provisions for regulating health and safety in relation to hazardous substances and describes the structures and procedures for setting OELs at the European level. It goes on to describe current changes taking place in regulatory policies on chemical substances, focusing especially on the proposals for new chemicals regulation known as REACH (Registration, Evaluation, Authorisation, of Chemicals), to Chapter 3 we turn to the regulatory provisions, institutions and procedures for setting OELs within the health and safety systems of each of the EU 15 member states. Chapters 4 to 9 detail these matters for the six countries listed above, to each country the mam focus concerns the practice of using OELs and is especially concerned with the role of OELs in regulating OHS management at the level of the enterprise. Each chapter therefore considers the role of OELs at the workplace level in each of the six countries. Using information from interviews with enforcement agencies, employers, trade unionists and other key stakeholders in each country, as well as documentary sources, the chapters offer a detailed analysis of strengths and weaknesses in the role of exposure limits in compliance strategies on chemical risk management at the workplace, to addition they report on a variety of current strategies that are undertaken in different countries to improve the management of the risks associated with working with hazardous chemicals and examine where OELs fit into these strategies. They discuss the practicability of these approaches, their application and coverage in relation to the emerging policies on chemical risks at national and international levels. In doing so they also take into account wider perspectives both in relation to perceptions of the value of OELs in managing chemical risks and in terms of structures and processes for OHS regulation more generally and the challenges they face. The national variations in these structures and processes are of direct relevance to the strategic significance or otherwise of OELs in the process of regulation and this significance cannot be appreciated fully without an understanding of the wider regulatory scenario. In Chapter 10, the concluding chapter, the information from the previous chapters is drawn together in a discussion in which the two themes of policy and practice that nm throughout the study are linked and the lessons that have been drawn from the analysis are presented.

13 13

THE PROBLEM OF CHEMICAL RISKS

INTRODUCTION In this Chapter we first present a brief outline of the role of chemicals in the economy of the European Union. We note the consequences of their use in terms of the effects of occupational exposure to hazardous substances on mortality and morbidity amongst workers. We then turn to a discussion of the relevant key approaches to regulating health and safety management of hazardous substances in the European Union. Since the book is concerned with the role of OELs in this regulation, the positions of OELs in current strategies to regulate chemical risk at European and national levels are outlined. This leads us to a reflection on some specific aspects of what OELs are and how they have developed and some key issues in understanding their meaning and appropriate use are identified and discussed. The chapter concludes with a discussion of the implications of these issues for the regulation of chemical risks that sets the scene for the chapters that follow.

CHEMICALS AT WORK IN THE EU According to the European Commission's White Paper on the strategy for a future chemicals policy, the global production of chemicals had increased from lmillion tonnes in 1930, to 400 million tones by the time the White Paper was published in 2001 (EC, 2001:4). The chemical industry in the EU produces about one third of total international chemical output and as such is collectively the largest chemical industry in the world, with an estimated turnover of some €556 billion in 2003 (for the EU 25 countries) (CEFIC 2004).

14 Beyond Limits 14

About 100,000 different chemical substances are registered in the EU, of which 10,000 are marketed in volumes of more than 10 tonnes and 20,000 marketed at volumes of between 1-10 tonnes. In 1998 world chemical production was estimated to be valued at €1,244 billion, of which the largest share (31 per cent) was produced by the EU chemical industry. It is Europe's third largest manufacturing industry, employing 1.7 million people directly with a further 3 million jobs dependent on it. Although large multinational corporations are prominent in the industry, in Europe there are also 36,000 SMEs (over 95 per cent of the total number of chemical firms in Europe) that between them are responsible for 28 per cent of chemical production (CEC 2001). The chemical industry itself is mainly concentrated in Germany, France, the UK and Italy. The largest share is in Germany with 26 per cent of total EU production, followed by France (17 per cent) the UK (14 per cent) and Italy (12 per cent). Chemical production is however only one aspect. The European Union remains the single largest market for the chemicals industry. Chemicals are used in vast numbers of workplaces across the whole spectrum of economic sectors, both private and public. In addition to the direct industrial users of chemicals supplied by their original manufacturers and importers, there are also formulators that use chemicals supplied by original manufacturers or importers in various combinations in their own products before marketing them to further users and there are distributors of these products as well as those of the original manufacturers and importers. There are several consequences of this for workers' health and safety and its regulation. First, it obviously means that the workers who may be at risk of exposure to hazardous chemicals will be found throughout the economy and not just amongst the employees of the chemical industry and its dependents. The most recent information provided by the series of surveys conducted by the European Foundation for the Improvement of Living and Working Conditions found that 22 per cent of respondents in the EU thought themselves to be exposed to dangerous substances for at least a quarter of their working time while sixteen percent thought they handled dangerous substances daily (European Foundation 2001). In an earlier study it was estimated that some 32 million workers in EU countries were exposed to occupational carcinogens (Kogevinas 1998) and there were between 35,000 to 45,000 per year.1 If these

As well as the direct products of the chemical industry occupational carcinogens identified in this estimation included environmental tobacco smoke, radon, diesel exhaust and crystalline silica. See also Finnish Institute for Occupational Health, 1998.

The Problem of Chemical Risks 15

experiences are typical for European workers generally it suggests that millions of workers across Europe as a whole are exposed to hazardous chemicals at work. Secondly, there is a huge gap in knowledge concerning the potential risks to human health associated with the enormous numbers of substances produced and marketed in the EU and only limited data on the exposure of large number of persons involved in using the substances and the situations in which they do so. Thirdly, the role of intermediaries in the downstream supply chain from manufacture to use contributes to the remoteness of some users from the original suppliers of the substances they are using. This may complicate, alter or obstruct the quality of information flow concerning safe use of chemical substances from supplier to end-user. Such potential effects on the consequent ability of users to use hazardous substances safely, therefore pose challenges for the chemical industry to fulfil its statutory obligations to the users of its products effectively and at the same time presents a problem for appropriate regulation.

MORTALITY, MORBIDITY AND OCCUPATIONAL EXPOSURE TO HAZARDOUS SUBSTANCES m EUROPE It has been estimated from EU aggregate data9 that nearly one third of all occupational diseases recognised annually in the EU are related to exposure to chemical substances (Musu 2004).10 Data on death and disease associated with occupational exposure to hazardous substances is available from a variety of sources such as those based on for example: -

National statutory reporting requirements for occupational diseases, injuries and fatalities Registries of specific conditions such as cancer, skin or respiratory diseases associated with occupational exposure Available from Occupational Diseases in Europe in 2001, Statistics in Focus, Population and Social Conditions No 15 Eurostat, 2004, http://eiiropa.eu.int/connn.eurostaP-Publications. A substantial proportion of these are caused by chemical dusts such as asbestos.

16 Beyond him its 16 Limits

— Household surveys of self-reported sickness absence — Epidemiologieal studies in relation to specific forms of ill-health and their occupational causes Despite the current widespread concern about the risks of hazardous substances in the workplace, there are considerable problems in defining the proportion of death and disease in society that can be accurately attributed to occupational exposure to hazardous substances. There are many reasons for the difficulties researchers have encountered in attempting such calculations. They include the limited completeness of officially reported data, which is often defined by laws that were put in place for reasons that are at odds with the collection of comprehensive data on occupational disease." Such data in some systems is known to under-report the occurrence of the conditions it records because of failure to report them on the part of duty-holders. There are national variations in the nature of what is required to be reported and in the administrative systems for recording it. These lead to further variation in the quality and comprehensiveness of the national data and make aggregation and consistency of such material problematic at a European level. There is often a time lag between exposure and onset of disease, which in some cases may be considerable and which means that the current information about health effects may, in fact, refer to exposures that took place at times in the past when such exposure may have been of a different character to that experienced at present. Other measures of the extent of the experience of ill-health may be derived from workers' own self-reporting such as undertaken in the Labour Force Survey in the UK for example. Such measures usually result in substantially larger estimations of the extent of work-related ill-health and may be useful in calculating time lost to economic production and burdens on the health care and social welfare systems, but as measures of the nature and extent of illhealth they are problematic for a number of other reasons to do with respondents' self-diagnosis and memory of their work experiences. Estimations of mortality and morbidity based on these sources or on extrapolations from specific studies are themselves also controversial in terms of the methodology adopted and the assumptions made about what is or is not included as indications of the extent of the harm being estimated, hi acknowledgement of such problems many current estimations provide lower and In some cases, such as in the UK for example such requirements have had more to do with limiting the number of claimants eligible for social welfare benefits than a desire to document the extent of a particular association between work and ill-health.

The Problem of Chemical Risks 17

higher limits to their figures according to the different elements of methodology and coverage in deriving them.12 Although detailed discussion of all these problems is beyond the scope of the present volume, the significance of the uncertainty to which they contribute is central to the strategic development of regulatory approaches to risk management of hazardous substances and the position of OELs in such processes. It is also central to a second important issue that current more systematic regulation of chemical substances at the EU level is attempting to cover - reducing the burden of mortality and morbidity associated with occupational exposure to chemicals whose health effects are little known and with situations in which exposure is unknown or unspecific. The approach of Doll and Peto (1981) to estimating the extent of mortality from cancer that is due to occupational causes has been the basis for several subsequent estimations.13 m one of the most recent of these, a study undertaken to inform the European Commission in its deliberations on current regulatory strategies on controlling hazardous chemicals, Postle et al (2003) estimate that 3.5 per cent of the total cancer mortality in the EU was associated with occupational exposure to chemicals and the authors suggest that about 20 per cent of such mortality may stem from exposure to currently unknown chemical carcinogens. Spokespersons for the chemicals industry have disputed these figures. They point out, amongst other things, that the authors of this study confuse the more general situation of working with hazardous substances with working with chemicals in the chemical industry. Based on evidence from large German chemical companies, they further argue that there is evidence to show that, in fact, measured exposure to carcinogens in large plants in the industry has declined (CEFIC 2003). On this basis they suggest that exposure to chemicals in similar plants in the industry is also likely to have declined and argue that this indicates the success of OHS management measures in the industry.14 "While these may be valid criticisms of the particular study undertaken by Postle et al for the European Such is the case in most of the sources referred to in subsequent paragraphs. However, in some cases the range between upper and lower limits is so great that such estimates are of limited practical use. See for example Kogeninas et al 1998; Morrell et al 1998; ILO 2000; Postle et al 2003. Also, more generally see Greenberg et al 2001; Leigh et al, 1999. See also Kromhout and Vermeulin (2000) for a more general discussion of long term trends in occupational exposure to hazardous substances.

18 Beyond him its 18 Limits

Commission, they do nothing to negate the wider evidence of the relationship between known hazardous substances and the extent of deaths from cancer, nor do they contradict the proposition that a substantial though unknown proportion of these deaths result from exposure to hazardous substances that are not yet identified as carcinogens. Cancer is by no means the only condition caused by exposure to hazardous substances. Other diseases, of the respiratory system, the skin and the central nervous system are also associated with such exposures, as are allergies and reproductive, developmental and endocrine disorders. They add up to a formidable burden of fatal and non-fatal illness caused by exposure to hazardous substances at the workplace. However, there are no reliable data concerning the full occurrence of such conditions on a European scale. Nor is there anything like complete data on exposure - although here again there are specific cases of very good exposure data-bases at national sectoral level.15 Although there are plenty of specific detailed studies that support both the idea that the health effects of occupational exposure to hazardous substances are substantial and a cause for concern, the full extent of this occupational exposure and its health consequences remains unknown. All this is a major challenge for regulatory strategies aimed at helping to reduce it. Indeed, if the logic of the argument applied by the chemical industry apologists outlined above is followed, the dimensions of the problem become apparent, for it is not the diminishing number of large chemical manufacturing firms that define its parameters. Rather, it is experiences of hazardous substances amongst users in the much larger and increasing numbers of small or fragmented workplaces in which sophisticated control measures such as those that result in reduced exposures in large chemicals firms are not in evidence and where contact with regulatory intervention is also unlikely. It is the reality of regulating the safe use of chemicals in this far more diverse environment that has exercised poEcy makers at national and European levels in recent years and it is to the role of exposure standards in this process that we will turn next. Before doing so however we need to say something about the nature of such standards.

Such as the database DOK.-MEGA run by the BGIA and the BGen in Germany for example - see Chapter 5).

The Problem of Chemical Risks 19

ISSUES FOR THE ROLE OF O E L S IN MANAGING WORK WITH CHEMICAL RISKS The main concern of this book is the role of OELs in the regulation of the risks of hazardous substances. Exposure limits are prescriptive standards in as much as they set specific requirements concerning the precise measures of particular substances that are allowed in the air of the workplace. They are based on scientific evidence concerning what is known about the biological effects of certain chemical substances combined with what is considered to be technically and economically feasible in achieving their control. Such standards are themselves not new. They had been used as technical guidance in occupational hygiene for several decades before being incorporated in the regulatory systems in many countries. However, incorporation gave them a different status to the one they held previously and at the same time has led to questions and concerns about their role. These concerns have become more prominent over the last decade as evidence questioning their usefulness within the system for regulating selfregulation has mounted, indicating the very limited degree to which duty holders understand them.16 Clearly, if many employers, especially those in small enterprises, do not know how to determine whether exposure levels in their workplaces comply with the relevant OELs, (or even that they should determine such matters) the role of limits, in the practice of managing the risks of hazardous substances at the workplace level, is open to question. Even more fundamental are questions concerning the meaning of OELs especially ones that address the extent to which they are misconceived to represent 'safe limits' by users. Such questions penetrate to the core of current thinking on risk communication and risk regulation. If the definition of the level of risk represented by an exposure limit for a 'hazardous substance' is prone to a misinterpretation concerning its meaning and limitations, then the whole system is also likely to suffer a loss of both sense and credibility in terms of risk communication. One of the major shifts that has occurred in public policy in In the UK the results of HSE commissioned research showed that only 16 per cent of a sample of respondents from establishments manufacturing or using chemicals mentioned complying with COSHH or OELs as legal requirements for work in such situations. They demonstrated an almost complete absence of detailed knowledge or understanding of the duties associated with OELs and Maximum Exposure Limits (MELs) (HSE 1997).

20 Beyond Limits

recent years has been the greater attention paid to societal perception of risk that has followed fiom the (somewhat belated) realisation that public perceptions of risk and especially of risk regulation are essential considerations if strategies on the governance of risk are to be successful. Following the catastrophic loss of public trust precipitated by governmental and 'expert' handling of issues such as nuclear power, BSE, foot and mouth disease and genetic manipulation, taking account of public trust has become a more significant aspect of regulation of risk in public policy. To do so, at very least, requires a participatory approach and a blend of clarity and transparency in both the decision-making processes and their end results. As well as the economic considerations that often affect whether substances have an OEL, there are also technical questions concerning problematic details such as the difficulties encountered in applying its criteria to certain substances, so that it is not possible to give them an OEL despite their known hazards. Such problems have contributed to a growing recognition of the need for reform. A further matter is the need for compatibility in standard setting procedures between EU Member States and procedures at the level of the EU. There are several reasons for this including the obvious requirement for general harmonisation in OHS regulation. More specifically, the question of the meaning of exposure limits, their toxicological basis and the issue of economic and technical feasibility of achieving best practice in the workplace have taxed regulators and practitioners for decades. There is consequently a history of standard setting structures, processes and outcomes at European level, the consequences of which policy makers and regulators are obliged to take account at national level. In the following section we sketch out some of these issues and provide some background to understanding the development of the role of OELs in chemical regulation. We begin with a brief outline of what occupational exposure limits are and how they have developed from scientific/technical standards to regulatory ones. In doing this we also consider some of the key issues that have exercised participants in the process of setting limits and in particular, questions of technical and economic feasibility that lie at the core of many of the debates surrounding regulating the risks of chemical substances. This leads to consideration of some relevant aspects of the relationship between societal risk perception and regulating the management of hazardous chemicals at work. Finally, we draw these various threads together by returning to the likely role of OELs in modern European

The Problem of Chemical Risks 21

approaches to regulating the management of hazardous chemicals at the workplace and the policy questions for regulating the (systematic) management of workplace chemical risks in the EU.

WHAT ARE OCCUPATIONAL EXPOSURE LIMITS AND HOW HAVE THEY DEVELOPED? Occupational exposure limits for airborne concentrations of hazardous substances are essentially measurable values of airborne (and therefore breathable) contamination by chemical substances that are points of reference for the development of workplace strategies to protect workers from health risks associated with inhalation of chemical substances. Beyond this general definition lie a number of levels of complexity and contradiction. Exposure limits have been proposed by individual researchers for particular substances and classes of substances since the late 19th and early 20th centuries (Hanson 1998). Several lists were published in Europe and the US in the 1920s and 1930s but the most influential was that of the American Conference of Governmental Hygienists (ACGIH) which published its first TLVs in 1946. The list was adopted by the US federal government as its official standard in 1969. Although from the outset certain other countries such as the USSR and the Federal Republic of Germany have determined their own limits, the dominant role that the ACGIH TLVs have played as a reference list for exposure standards in industrialised countries is well documented," The development of single figure exposure limits such as were found in the ACGIH list has been well described by Piney (1998) who applies Kuhn's (1970) theoretical explanation of the role of the paradigm concept in scientific communities to trace the development of TLVs in the US. He suggests that in the 1940s the history of science-based exposure standard setting, which until then could be characterised as being in a (pre-scientific) pre-paradigmatic stage, changed into a (scientific) paradigmatic period that was shared by both the See for example, Cook 1985, Hanson 1998, Mendeloff 1988, Piney 1998, Stokinger 1984, 1988 and Ziem and Castleman 1988 for accounts of the history of the development and use of TLVs.

22 Beyond Limits

science-based professions of industrial hygiene and industrial toxicology.18 Fundamental to this approach was the notion that it was theoretically possible to prevent risks to health through a combination of industrial toxicology and occupational hygiene that could quantify exposure levels of hazardous substances in workplace atmospheres with an exactness that would enable distinguishing between those atmospheres in which there was no risk to health and those in which levels of contamination with hazardous chemicals posed a threat. Unfortunately, reality has proved to be more complicated than this. While the approach and the ACGIH TLV list itself have been enormously influential in industrialised countries worldwide, for many reasons, it is an approach now recognised to have considerable flaws. From the 1970s, other countries, notably those in the EU, began to develop their own lists, although the influence of the ACGIH list was still widely felt in these separate national approaches. It is generally acknowledged that the TLV list is the most widely circulated and significant set of exposure standards in the industrialised world and its formal and informal influence on various national policies and practice is considerable, as is evident in most of the countries we studied. Germany's limits (Maximale Arbeitsplatzkonzentmtionen — MAKs) have developed separately from ACGIH and are said to be based exclusively on scientific information about health effects. Its documentation states that 'scientific criteria for the prevention of adverse effects on health are decisive, not technical

What this means essentially is that prior to the 1940s several approaches to exposure standards can be traced, in particular the use of specification standards in which controls were specified but control effectiveness was not The development of the profession of industrial hygiene was strongly linked to the measurement of the effectiveness of controls and hence to the use of exposure standards. Combined with the professional concerns of industrial toxicology (health effects of exposures) such standards could be used to achieve (theoretically) risk free atmospheres. Thus the paradigm of single value exposure limits was a powerful binding notion for the two science-based professions to develop a truly preventive approach to preventing damage to workers' health. While acknowledging oversimplification (which does not account for the criticism of the OEL paradigm from within the industrial hygiene community), this explanation of the mutually reinforcing growth of the profession of occupational hygiene and that of the status of the TLV list is nevertheless persuasive (see also Piney 1989).

The Problem of Chemical Risks 23

or economical feasibility'.19 Carcinogens and genotoxic substances are given TRK values because it is accepted that such limits cannot be based exclusively on health considerations.20 However, since 1 January 2005, technically based TRK values have been replaced by a new type of value (Arbeitsplatzrichtwerte or ARWs) which is not any longer health but risk based. The consequences of this will be discussed in more detail in Chapter 5 on Germany. There is no longer any explicit influence of the ACGIH on the development of exposure limits although they were used historically. In Greece, occupational exposure limits are a relatively late addition to national regulation of occupational health and safety. There is an agreement between the Greek national health and safety institute (ELINYAE) and the ACGIH and since 1997 the latter's list is translated and published in Greece. Italy has a history of not including limit values in national legislation, preferring a general requirement on employers to reduce levels of workers' exposure to as low as is technically feasible.11 However, certain collective agreements such as for example the one that exists in the chemical industry provides for the adoption of the exposure limits in the ACGIH list. Since such agreements have legal status in Italy this means that the standards in the list are also legally binding. In the Netherlands until 1977, the ACGIH TLV list was used. The first official Dutch list of MACs was published in 1978 but it consisted largely of the ACGIH TLV list of 1977. Since then, new MACs and changes in existing MACs have been established according to a procedure which separates evidence on health effects from issues of economic and technical feasibility. However a large number of current OELs remain those adopted from the ACGIH list of (around 300 such substances are currently under review).22 See Senatskommission 1996:9. "The present theory of chemical carcinogenesis indicates that even the lowest doses will produce some genotoxic damage irrespective if the observation or non-observation of tumour formation in finite experimental conditions" (Henschler 1991:15 quoted in Hanson 1998:37). But implementation of the IOELV Directive clearly changes this. A similar situation exists in the UK. where something like 350 substances have an OES that is unchanged since the last TLV list of 1980 and have not been assessed by the ACTS/WATCH committee to see if the OBS criteria are met.

24 Beyond Limits

Sweden also has had its own system since 1969 - although the list issued at this time was based almost entirely on the TLVs of the ACGIH. Since 1978 it has made a concerted effort to separate the decision-making processes dealing with scientific issues concerning the health effects of chemicals from those that deal with economic and technical feasibility. This has had an effect of gradually reducing the levels of exposure limits. According to Hanson (1998) there has been a 3.9 per cent average yearly reduction of the values of exposure limits overall, a 5 percent reduction for solvents and a 10 per cent reduction for carcinogens, generally giving Sweden the lowest limit values in Europe. In the UK the ACGIH list of TLVs was the basis for exposure limits until the 1980s when a UK provision of control limits and exposure standards was developed and incorporated into the regulatory approach encompassed by the Control of Substances Hazardous to Health (COSHH) Regulations. Despite this British regulatory position however, the majority of the limits adopted remained unchanged from those of the ACGIH list of TLVs. Discussion on exposure limits at EU level was an inevitable development of Directives intended to address the control of hazardous chemical agents that made their appearance during the 1970s and 1980s.23 Stemming from such legislative actions came moves towards setting European exposure limits during the 1990s. Reflecting national concerns about the meaning of exposure limits, debate about the scientific basis and meaning of limit values (see below) was a central feature, hi the following chapter we examine the extent to which national structures and processes reflect these requirements and their legal status. In subsequent chapters we look in greater detail at the effects of these regulatory systems and strategies to improve the management of occupational health and safety for hazardous For example, in 1974 the European Council initiated a Social Action Programme that included specific reference to health and safety. It led to new Directives on safety signs, and vinyl chloride monomer. In 1978 the first Action Programme specifically on health and safety was announced. The most significant legislation made under this programme was a framework Directive on the control of chemical physical and biological agents at work, (Directive 80/1107/EEC, later amended by Directive 88/642/EEC). There were further directives on asbestos, lead and noise. Outcomes that were achieved at this level had a significant impact within Member States, where the approach of the directives towards the assessment of risk, was arguably an influence on the development of national strategies in the UK on the control of substances hazardous to health.

The Problem of Chemical Risks 25

substances. Before doing this we outline some of the debates and issues surrounding the application of OELs in the regulation of risk management of hazardous substances.

THE MEANING AND USE OF EXPOSURE LIMITS OELs have moved from the domain of occupational hygiene and industrial toxicology, where they were originally conceived essentially as reference materials for specialists involved in monitoring occupational exposures to hazardous chemicals, to legally enforceable limits that feature in regulatory strategies. This has meant that the key issues involved in understanding the meaning and use of OELs, have both increased in significance and altered in nature. Such issues are critical aspects that influence the development of policies on OELs and in the user and public understanding of such policies. The predominant ways in which these changes have been interpreted and applied in different countries has helped to shape the way that OELs are perceived, valued and used. An outline of the general background to some of the key issues of meaning and application of OELs is therefore relevant. Health based values and what is technically feasible. Recent discourse on the OELs that are used in practice in the countries of the EU, goes to some lengths to be clear that they do not represent 'safe levels' of exposure for all workers, nor is it intended that they should set a limit below which it is unnecessary or undesirable to reduce exposures further. The Scientific Committee on Occupational Exposure Limits (SCOEL) is quite clear about this, stating for example: "It should however be emphasised that it is always prudent to reduce exposure as far below OELs as can reasonably be achieved, in order to provide the greatest degree of health protection" The introduction to the ACGIH TLV list explains that TLVs are intended for use in the practice of industrial hygiene, they do not represent fine lines between safe and dangerous concentrations of hazardous chemicals. However, the originators of the list were confident that TLVs would protect the majority of workers from harm and they have been thus extensively promulgated as essentially safe levels

26 Beyond Limits

of exposure under which "nearly all workers may he repeatedly exposed, day after day, without adverse health effects. "M There are a number of well-documented reasons to believe that it is a fundamental misconception to regard TLVs as 'safe levels'. The evidence on which they are based has in many cases been shown to be alarmingly incomplete. Historically it has been reliant on a substantial amount of unpublished (and unevaluated) corporate information, and the ACGIH committee itself has been accused of being prone to corporate bias (Castleman and Ziem 1988). Since TLVs are intended to protect 'normal' workers but not those that may be particularly sensitive to chemical exposures, it is clear that 'normality' excludes a substantial proportion of workers. Perhaps most tellingly, harmful effects at levels below TLVs are easily found in the ACGIH's own documentation (Roach and Rappaport 1990), as well as elsewhere in the scientific literature and (Ziem and Castleman 1989), One reason why the US ACGIH system attracted so much criticism once it took on a degree of federal regulatory significance, is the considerable blurring in its approach between the procedure used to derive a so called 'health based' standard and the question of technical and economic feasibility.25 Modem civil society demands far more clarity and transparency on issues of risk assessment than was evident in the ACGIH procedures which, at best, could be described as a form of expert risk assessment in which the expert's own socially constructed assumptions about risk (that is those influenced by their own social as well as scientific experiences) remained unquestioned and at worst, a system in which key economic considerations of industry covertly determined levels that purported to be scientifically derived health based standards. Once OELs started to play a role in regulatory policies, European policy makers attempted to avoid this confusion Quoted from the preamble to the TLV List still appearing in the 1990s (ACGIH 1996: 3, in Hanson 1998: 21). Technical and economic feasibility are terms that appear frequently in the literature qualiflying and explaining the setting of OELs. Within a UK context the terms largely equate with notions of reasonable practicability such as defined by British case-law. Where technical feasibility appears alone it might appear to mean something that could be technically possible to achieve without regard to cost. However in practice, it is seldom used to mean this as it is almost impossible to distinguish something that is technically feasible from consideration of the costs involved in its technical achievement. We have therefore tried to reflect this by using the term "technically and economically feasible wherever possible.

The Problem of Chemical Risks 27

by creating clearer demarcations between the procedures that deal with the science of deriving a health-based limit and those that deal with setting a value that is believed to technically and economically achievable. The first of these procedures involves the scientific assessment of evidence of the harmful effects of a substance, undertaken by persons judged to possess the scientific competence to do so. The second engages the involvement of stakeholders in debate about the extent to which it is possible to agree measures to protect workers, that are at the same time economically and technically feasible to implement in the workplaces affected. One size fits all and the 'dirty end'. Different processes (and sometimes industries) cause different distributions of exposure. The major problem for standard setters in setting single all encompassing figures as limits is how to deal with those processes (industries) causing the greatest exposure. If single level exposure limits are set to accommodate, for example, a powerful lobby from a particular branch of industry that argues it is not economically or technically feasible to reduce exposure below a certain point in that industry, the same OEL is likely to apply to exposures in other industrial sectors, even though in such sectors it may be technically and economically possible to reduce levels of exposure to well below this OEL. Critics of existing OEL systems point out that in many cases it is the so-called 'dirty end' of industry (i.e. the sector of industry in which exposures are greatest and most difficult to control) that in fact plays a powerful role in determining the value that is eventually agreed to be economically and technically feasible, despite this sector of industry only accounting for the exposure of a relative minority of workers. While it may be argued that there is nothing that prevents the rest of industry reducing the level of exposure to as low as possible below the OEL, and in many cases regulatory agencies recommend building safety factors into the use of the limits (such as working to a percentage of the value that represents the actual limit), the message that is conveyed by the legal status of the limit is that employers are only required to do as much as is necessary to demonstrate they are within it. There is often no legal incentive to do more than this. Since exposure limits do not represent safe levels for the health of workers, this approach potentially has the effect of unnecessarily increasing the risks faced by the majority of workers to suit the technical and economic needs of a minority of employers in parts of industry in which exposures are greatest. Participatory approaches to standard setting. The European approach is also a product of a regulatory strategy for occupational risks in which an orientation

28 Beyond Limits

towards process regulation has been a feature characterising regulatory systems for OHS in northern European countries since the 1970s. This is especially the case in the Netherlands, the UK and in Scandinavian countries, but latterly it is also true more generally across the EU, as EU Directives based on this approach are implemented and operationalised in all EU countries. In efforts to 'regulate the self regulation' of risks at work the characteristic elements of defining the extent of employers' duties, information and consultation rights for workers and levels of competence for support services are (more recently) coupled with measures to ensure that the management of risks is undertaken in a manner in which employers discharge their duties competently (with the assistance of competent prevention services for example), systematically (by integrating OHS management into the core management of the enterprise and through assessing and controlling the risks of their activities) and involving workers and their representatives in participative approaches to OHS management. At the sectoral and national levels, risk assessment and control is also largely envisaged as a participatory process in which stakeholders, primarily employers and trade union representatives, (that is, those that 'create the risks and those that work with them'),26 engage with representatives of regulatory bodies in both developing and implementing strategies of risk assessment and control. The means and structures by which OELs are discussed and defined are part of this approach and are therefore probably better understood as an aspect of this wider development rather than as unique structures and procedures for dealing with the regulation of chemical risks. Chemical hazards and 'risk society'; OELs, the social construction of risk and risk communication. Whatever the infrastructural context of OELs-in-the-making, the importance of the status, clarity and transparency of the decision-making involved has become fundamental in societies in which concepts of risk, governmental roles and responsibilities in its regulation and accountability of duty holders to the public have all gained increased prominence. In the 'risk society* described by social analysts of late modernity" it is often the 'invisible risks' of life that characterise societal concerns. Issues of trust and public understanding of the scientific reasoning behind decision-making in environmental matters have become such that regulators and decision-makers have been forced to rethink their approaches to risk analysis and take both public perceptions of their activities and To paraphrase the words of one of the significant harbingers of this system, Lord Alfred Robens (Robens 1972). See especially Beck (1992).

The Problem of Chemical Risks 29

public engagement with them more seriously. The political consequences of not doing so have been shown to be of sufficient significance to force governmental policy makers to give at least some consideration of the notion that expert risk analysis is itself not free from social constructions of reality and to move towards systems for decision-making on public policy on risk regulation in which such considerations can be addressed. Debate on the relationship between regulation and risk has burgeoned in recent years and discourse has become increasingly sophisticated as analysis of the subject has deepened.28 As Hutter elaborates, regulation is a form of control in which risk itself is not prohibited, rather it is an attempt to manage it, in which structures, routines and procedures are constituted 'which will be incorporated into organisational routines and also become part of everyday individual activity. Where this fails the law can intervene through more overt forms of control, notably external regulation and sanctions.' (Hutter 2001:5). In the case of OELs, what this seems to mean is that the participants in the processes of setting limits and the information generated as a result of the process should be more representative of users as well as experts. They should be clear that what is being set by their contribution to the process, is not a 'safe limit' but rather a tool in the assessment and management of risk, which, if it properly applied should contribute to more effective and systematic management of health and safety in the use of hazardous chemicals. Unfortunately (even if this were true) it does not necessarily follow that actual users of OELs will be in the same position. Indeed, one of the most significant problems with the current British system for example, is the considerable absence of understanding amongst employers and managers, especially in smaller firms, about OELs and how to comply with them (HSC 2002:19) coupled with a widely held belief that they are See for example, Ayres and Braithewaite 1992, Gunningham and Johnstone 1999, Hutter, 1997 and Hutter 1999, in relation to the development of regulation on occupational health and safety and the environment. More generally see Colebateh 1989, Bardach and Kagan 1982, Hancher and Moran 1989 and Selznick 1980 for the theoretical analysis of the role and meaning of regulation in advanced industrial societies. See Ericson and Haggarty on the relationship between risk and regulation, Jaasanoff et al 1995, Nelkin 1992 and Wynne 1994 and 1996 on the relationship between risk and science and for a more specific attempt to relate the theoretical analyses of risk and regulation to occupational health and safety management see Hutter 2001:2 -23.

30 Beyond Limits

"safe' limits. As the HSC points out this latter view is probably reinforced by the fact that once a limit has been met the employer has fulfilled his/her legal obligations. As we shall see, such problems are also much in evidence in systems that do not share either the particular history or the features of the present British approach. While it may be that some of these problems of user understanding could in practice be tempered by a revision of the system to include a clearer obligations on employers to reduce risks to as low as technically feasible below the OEL for example, it is far from certain that they would dispel the myth that the OEL represents a safe level. A much broader question which also needs to be asked is: to what extent has the introduction of a system of limit values with the legitimacy of legality, contributed to the development of totemic significance for the notion of a numerical value that can delimit one state such as safety from another, such as danger, in the use of hazardous chemicals. Clearly, if this is the case it is part of a much wider problem of perception in which the notion of measurement implies the existence of numerical values that can distinguish precisely between one such state and another. This is a misrepresentation of reality, but one likely to require widespread re-education and policy reorientation to dispel. The extent to which these issues are a feature of national systems in Europe and to what extent alternative conceptualisations occur are questions to which we will return in the final chapter.

NEW DIRECTIONS IN REGULATING RISK MANAGEMENT OF HAZARDOUS SUBSTANCES AND THE ROLE OF O E L S It is important to consider the development of the role of OELs in regulation in relation to the evolving features of current approaches to regulating the management of hazardous substances at work more generally in EU member states. Although they differ in the details of their systems for regulating OHS, since the adoption and transposition of the Framework Directive 89/391, most EU 15 countries have a broadly similar approach to regulating the process of managing health and safety (Walters 2002). Their regulatory requirements aim to provide a structure within which employers and workers can be encouraged towards achieving self-regulation of the risks of their workplaces. As one observer of the development of this international trend in the regulation of the working

The Problem of Chemical Risks 31

environment has put it, they are measures that aim to regulate self-regulation.19 These frameworks provide structures and processes applied to the management of all hazardous chemical substances at work, as well as dealing with specific substances such as lead, benzene, and named carcinogenic substances. OELs feature in both. Indeed, if OELs were not already incorporated into these regulatory systems, the adoption by the European Community of the Chemical Agents Directive and its first Indicative Occupational Exposure Limit Value (IOELV) daughter directive and their transposition into national requirements should have brought this about in all Member States. At the workplace level OELs are standards against which employers can measure the extent to which their risk management strategies are controlling the occupational exposure of workers to airborne hazardous substances. However, the extent to which employers undertake the fundamental health and safety management procedures such as risk assessment in relation to chemical as well as other hazards has been shown to be far from universally complete. It has for example been shown to be, inversely proportional to the size of the enterprises for which they are responsible. This has been demonstrated in a wide range of studies concerning the implementation of the measures of the Framework Directive 89/391 .M Additionally however - and as we document in greater detail in the following chapter - despite the many measures aimed at controlling the risks of chemical substances in Europe, gaps in coverage and limitations in orientation have become increasingly apparent. For example there is a general lack of knowledge about the properties and uses of existing chemical substances.31 There is little information concerning the scale of use or levels of exposure occurring to downstream users of such substances and only limited information on the extent and detail of associated ill-effects. Nor do we know the most effective ways in which such ill effects can be prevented or reduced in practice in the complex work environments in which they occur.

See Ayres and Braithewaite (1992). For a more recent discussion of this point see Walters (ed) 2002:271-275. See Walters 2001 for a review of such evidence. Traditionally the regulation of chemicals in the EU has distinguished between new substances for which there have been quite detailed provisions concerning the assessment of the risks they pose to human health and the existing substances that make up the vast majority of chemicals used in European workplace for which no such provisions exist.

32 Beyond Limits

At the present time therefore a further dimension to regulating risk management in relation to chemical substances is in the process of unfolding as renewed efforts are being made to provide a more comprehensive approach to regulating risk and to deal with some of the complexities and uncertainties outlined above. At its core is an effort to adopt a more holistic view of the role of regulatory intervention in relation to working with hazardous substances and it is important to understand the role perceived for OELs in these emerging regulatory strategies, as well as in existing approaches to regulating systematic OHS management. The White Paper heralding the introduction of the REACH principles made this clear. In 1998 following concerns expressed by the Council of Environment Ministers, the Commission undertook an assessment of the operation of the four main legal instruments regulating safe use of chemicals in the European Community.32 Its report and the consultation that followed pointed towards the piecemeal approach of existing regulatory policy, noting the distinction in its approach towards the large number of 'existing substances', for which there was little information concerning their properties and use, and the much smaller number of 'new substances' for which more thorough information was available. It noted the slowness and resource intensiveness of the risk assessment processes in relation to substances as well as the inappropriate distribution of responsibilities involved - with too much focus on the responsibilities of the authorities and not enough on those of enterprises producing importing and using substances - leading to poor quality of information on use of chemicals and its consequences, especially in relation to downstream users. It found that existing regimes in place to address the liability of duty holders for damage caused by chemical substances were inappropriate and insufficient to provide effective remedies because of their emphasis on the need for causal connections that in practice were impossible to establish because of the remoteness of the parties concerned (CEC 2001). For the Commission the solution was to propose the new regulatory strategy announced in its White Paper. Prominent amongst the principle elements of the new approach encapsulated in REACH is the aim to achieve realignment of the responsibilities of duty-holders for ensuring the safe use of chemical substances in Council Directive 67/548/EEC and Directive 88/379/EEC, on classification, packaging and labelling of dangerous substances and preparatins; Directive 76/769/EEC restricting the marketing and use of certain dangerous substances and preparations and Council Regulation 793/93 on the evaluation and control of risks of existing substances.

The Problem of Chemical Risks 33

ways that encourage a more joined-up approach through influencing supply chain relations and promoting product stewardship, covering the full range of manufacturers, suppliers and users involved with chemical hazards. Additionally, through the same broad framework of realigned responsibilities, the strategy encompassed the regulation of chemical hazards in relation to the wider environment. A detailed description of the provisions foreseen under REACH (at least as it was foreseen in the proposal presented by the Commission in October 2003) will be provided in the next chapter. In the context of the present discussion it is worth noting that REACH intends to establish a system which will trigger different testing requirements based on the annual production or imported volume of a substance (independent whether of being a new or an existing substance) before the substance can be marketed in Europe. In a nutshell that means that the higher the amount of a substance, the higher the test requirements. However, the whole system will only start from a production / import volume of above 1 tonne and the test requirements for substances produced / imported between 1 and 10 tonnes per year are less severe than those currently applied for new substances of the same intended production volume. With respect to setting OELs for substances which do not have a limit value assigned so far, these distinctions are important because the test requirements for the lower tonnage are very limited. Only physio-chemical data33; on skin and eye irritation, skin corrosion and skin sensitisation, one in vitro mutagenicity test and basic environmental tests will be required for these substances (which are assumed to represent two thirds of the total number of substances) which will fall under the scope of REACH. There is however agreement about the fact that a minimum of data must be available to derive health based OELs (which should be in any case the basis for an OELs, even if technical and economical feasibility factors are taken into account afterwards). This minimum set of data comprises the above mentioned physical and chemical data, but also data on acute, subchronic and chronic toxicity using different exposure routes (via inhalation, dermal, oral). If available, genotoxic data, sensitising properties, reprotoxic data should also be taken into consideration. If the available data allows to derive a socalled NOAEL (a no adverse effect level), then a threshold or limit value can be Melting and freezing point, boiling point, vapour pressure, water solubility, flammability etc.

34 Beyond Limits

arrived at. This is the procedure used for effects which normally only occur above a certain concentration or in other words for substances which do not have an adverse effect on human health below a certain concentration.34 This means that the data set required for substances between 1 and 10 tonnes will not be enough to derive OELs. However, REACH will at least generate some data for substances for which no data is publicly available today." Even if this data might not necessarily be usable for establishing OELs, it will nevertheless be helpful in providing information concerning the risks of substances to be used in European workplaces. What is even more important with respect to OELs and workers' protection is that for all substances produced / imported in quantities above 10 tonnes so-called Chemical Safety Reports (CSR) will be obligatory. A CSR will be based on a Chemical Safety Assessment and contain a description of the manufacturer's or importer's exposure scenario(s), (including exposure scenario(s) they recommended to be implemented) for the identified use(s) of the substance in question. The exposure scenarios contain a description of the risk management measures which the manufacturer or importer has implemented and recommends to be implemented by downstream users. If the substance is placed on the market, these exposure scenarios including the risk management measures shall be summarised in an annex to the safety data sheet. This will provide downstream users in particular with more targeted information with respect to the intended uses and this is, for most substances, far more information than is currently available to users. So in theory, the new system will improve the situation at the work place.36 However, as we discuss in the final chapter of this book, regulatory provisions require proper implementation and surveillance. As we shall see, experience with existing legislation has not been encouraging in this respect.

For other effects like carcinogeniciry such a threshold does not exist. For those substances if considered to be not substitutable for the time being - risk based limit values are established, taking technical and economical feasibility into account. And this is the majority of substances used in Europe. 'In theory' also because at the time of writing, the final version of REACH had not been decided and there remains the possibility of further changes being made.

The Problem of Chemical Risks 35

CONCLUSIONS: BUT WHAT ABOUT USING OELS? Despite some success at reducing measured exposure in large chemical plants through introducing more systematic approaches to risk management, it seems clear that the scale of the problem represented by the quantity and range of chemical substances in use as well as by the variety of situations in which they are used remains formidable. There are major challenges for the control of prevention in relation to known health effects of hazardous substances, arguably even greater obstacles represented by the uncertainties about the health effects of large numbers of substances in current use and concerning the ways in which they are used. Therefore the challenge for regulation of risks associated with the use of hazardous substances at work in the European Union continues to be significant. Systematicity of risk management strategies in relation to hazardous substances requires good quality information concerning their health effects and the extent and nature of their use as well as on the economic implications of control. Generating OELs is part of this process and they have been agreed for a limited number of chemical substances. In this chapter we have summarised some of the issues of meaning and usage that have beset the processes involved in reaching agreement in setting OELs, especially since they have assumed a form of regulatory status. We have further outlined the role perceived for OELs in chemical risk management at the workplace level, both in the regulatory approaches towards systematic OHS management that have been the leitmotif'of the EU approach since the early 1990s and also in the newer and more holistic approaches that are aspired to by current EU approaches to regulating chemical risks. In all of this we find a wealth of material analysing the origins, development and status of occupational exposure limits. There is also much critical discussion of the reliability of the evidence on which different kinds of exposure limits have been set as well as what they actually mean in terms of protecting workers' health. It is beyond the scope of the present chapter to present anything more than an outline of some of the salient aspects of this material. Similarly, there is a substantial field of literature dealing with approaches to regulating risks in society, dealing inter alia with assessing risks, the social construction of risk and risk communication, all of which are relevant to strategies on setting exposure limits. There is also a growing literature on changing approaches to regulation of

36 Beyond Limits

the occupational environment. Again we have outlined a few of the relevant issues from these fields that have a bearing on our interests in occupational exposure limits. However, while there is an abundance of material that considers the issues surrounding OELs at the level of their making, status and meaning, the same cannot be said about literature that analyses their use at the workplace. Indeed, matters such as how OELs are actually used (or if they are actually used) are conspicuously absent from the extensive literature on OELs and on the management of chemical hazards generally. It is disconcerting to discover that such limited attention appears to have been devoted to what is actually done in practice with OELs following the extensive debate that has taken place concerning their status and meaning. This is especially so given that what little information that does exist suggests that at least in the UK there are a majority of employers who neither understand their meaning nor use OELs appropriately, despite being significant users of chemicals in their work operations (HSE, 1997; Piney, 2001). It was with these limitations in mind that we set out to explore the practices at the workplace level to which the remainder of this book is largely devoted. First however it is important to outline in more detail the main existing European legislation addressing dangerous substances in general and the structures and processes for setting and using OELs at EU and national levels as well as the regulatory contexts in which they operate in the various EU 15 countries. These are the subjects of the following two chapters.

37

EXPOSURE LIMITS AND INSTITUTIONAL STRUCTURES FOR HAZARDOUS SUBSTANCE REGULATION IN THE EUROPEAN UNION.

INTRODUCTION In this chapter an overview is presented of the various structures that have developed at European Union level in which OELs are determined and used in the process of regulating chemical risk management. Its aim is to provide the reader with some understanding of the regulatory context for OELs at this level and their role as instruments in regulatory strategy for risk management of hazardous substances. To do so first requires an account of relevant EU legislative arrangements that provide the legal framework within which chemical risk management operates, as well as information on particular provisions relating to the specific status and role of OELs. In addition information is necessary on the EU structures and processes involved in setting OELs. This makes for the presentation of a complex legal and institutional story. To facilitate it, while at the same time providing a route map to aid readers' understanding of the key issues that relate to setting and using exposure limits and the dynamics of their development at this level, the focus of the chapter is more concerned with the rationale behind the regulation of chemical hazards than with its detailed requirements. It begins with an account of the logic behind the array of Community level provisions that make up the legislative framework in which the protection of workers' health and safety from damaging workplace exposure to

3 8 Beyond Limits him its 38

chemical and biological agents is currently embedded. It includes an indication of the relationship between instruments relating to the control of risks from chemical and biological substances and those dealing with risk management at the workplace more generally. Following this outline, the chapter focuses on the position of exposure limits within the framework for regulating chemicals. Again, it is necessary to understand a little of the situation in previous times if the current position is to be properly appreciated. The existence of key institutions at EU level are outlined and their past and present roles in establishing OELs explained before some of the features of the documentation of exposure limits are described. On-going change in policy development behind the whole framework for regulating risk from hazardous chemicals however, means that not only is it important to describe its historical underpinnings and the relationships between instruments in the existing system but it is also necessary to note some of the major changes currently under discussion in this field, whose outcomes may have implications for the future determination and use of exposure limits. A brief account is therefore included concerning the identified weaknesses in the existing system and the rationale behind the current proposals on the development of the integrated system of chemical regulation, the elements of which - (Registration, (Evaluation and (Authorisation of (CH)emicals - have given rise to the now well known acronym REACH that is the subject of widespread current international debate.

EU LEGISLATIVE FRAMEWORKS FOR MINIMISING HEALTH AND SAFETY RISKS OF DANGEROUS SUBSTANCES Existing EU health and safety legislation aims at minimising the health risks from dangerous substances in the workplace. The control measures to protect workers focus on principles of elimination and substitution. The most important pieces of European legislation in this field are listed below where they have been separated into two broad groups - those generally concerned with requirements on the producers of chemicals and those mat are more specifically related to the workplace. Their requirements represent the three main European methods for dealing with chemical risks, through hazard identification, risk assessment and in a final step, risk reduction. As we have pointed out elsewhere in this book, in terms of their operation at the workplace level all these measures also need to be understood in relation to the

Exposure Limits in in the the EU EU 39 broad requirements of the Framework Directive, 89/391 which although it does not deal with hazardous substances directly, contains the basic provisions for managing health and safety at work generally, thus providing the regulatory context into which all specific provisions on managing particular risks fit including those from using chemical substances.

Important Directives with special significance for the protection of workers: Directive 98/24/EC37 on the protection of the health and safety of workers from the risks related to chemical agents at work Directive 04/97/EEC38 as amended on the protection of workers from the risks related to exposure to carcinogens at work Directive 2000/54/EC39 as amended on the protection of workers from risks related to exposure to biological agents at work. Other important pieces of European legislation on controlling trade in chemicals that contribute to the framework for regulating chemical risks in the EU: Directive 67/548/EEC40 and Directive 1999/45/EC4' on the classification and labelling of dangerous substances and preparations and their adaptations to technical progress

Council Directive 98/24/EC of 7 April 1998 cm the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC). Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version) (Text with EEA relevance) (OJL158 30.04.2004p. SO). Directive 2000/54/EC of the European Parliament and the Council of 18 September2000 on the protection of workers fiom risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC). Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Official Journal No P 196,16708/1967, p. 0001-0098.

40 Beyond Limits Regulation (EEC) 793/934Z on the evaluation and control of the risks of existing substances Directive 76/769/EEC43 on restricting the marketing and use of certain dangerous substances and preparations and its amendments.

REQUIREMENTS REGULATING CHEMICAL RISKS GENERALLY INTHEEU In the series of Directives beginning with Council Directive 67/548/EEC, and following through Directive 1999/45/EC and Directive 91/155/EEC (as amended) that have been made to harmonise and control the marketing of dangerous substances, two central elements are evident - requirements on hazard identification and assessment. In addition, the requirement on producers to deliver these elements has a universality of application, distinguishes new substances from existing ones and places a major emphasis on responsibilities of producers to communicate information to users. It also utilises, where necessary, measures that restrict the marketing and use of certain dangerous substances and preparations. Responsibilities of Producers to Identify Hazards. The first Community legislation regulating chemical risks was Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (known as the Dangerous Substances Directive or DSD). Its aim was to identify so-called intrinsic hazardous properties of substances that were either already on, or were intended to be, placed on the European market. Although originally designed to cover in particular hazards which might pose a risk when 41

42

43

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations Official Journal No L 200,30/07/1999, p. 0001-0068. Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances Official Journal No L 0S4,05/04/1993, p. 0001-0075. Council Directive of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (76/769/EEC).

Exposure Limits in the EU 41

handling hazardous substances at the workplace, additional concerns like those for the environment or for consumers were included when brought under the scope of the Directive over the years — in a similar way as they were perceived to be threats to human health and the environment at Community level. Another equally important reasoning for the directive was the elimination of technical barriers to trade, to be achieved by harmonised and legally binding obligations for manufacturers, producers and importers of hazardous chemicals to classify and label them according to the hazards identified under the Directive. The Directive covers fifteen classes of danger for human health and the environment. It has been amended eight times and its annexes have been adapted to technical progress 29 times. Since 1981, it has discriminated between so-called new and existing substances (by which is meant substances either on the European market before or after a specific point in time (1981). Those that were on the market before that date are listed in the so-called EINECS list.44 Substances which are not on this inventory and which are produced in volumes as low as 10 kg per year are subject to a formal hazard assessment procedure*5 before they can be marketed in Europe. Only about 3000 new chemicals underwent this procedure after 1981. Generally, for substances that existed before 1981, there is no such provision. However, a small number of these existing substances have to undergo a risk assessment, but only those which are produced in high volumes (about 140 out of the 100,000 substances listed in EINECS - for further details see below). Communicating information to users. Once identified as dangerous, a substance is listed in Annex I to the Directive, and its hazardous properties have to be communicated to the user via information provided in a very condensed form on the label of the package,46 and in a more detailed form in so-called Safety Data Sheets.4' Under Directive 91/155/EEC as amended48 (the Safety Data Sheet

European Inventory of Existing Commercial Substances. The higher the production volume, the higher the risk assessment requirements In the form of pictograms, symbols and R(isk) and S(afcty) phrases. These data sheets, however, have only to be supplied to such users of a substance or preparation. Directive 2001/58/EC of 27 July 2001 amends Directive 91/155/EEC on the detailed arrangementi for specific information on dangerous preparations in Article 14 of European Parliament and Council Directive 1999/45/EC and relating to dangerous substances in

42 Beyond Limits

Directive) industrial/occupational users49 are entitled to receive additional information via Safety Data Sheets (SDSs). SDSs provide the user with basic information on the physical-chemical and toxicological properties of a substance / preparation as well as information on how to handle, use, transport and dispose of the chemicals in a safe way at enterprise level. In addition, information on first aid measures hi case of fire, accidents or other emergencies has to be provided. Existing substances that are dangerous but not listed in Annex I have to be classified and provisionally labelled by the manufacturer, distributor or importer. The corresponding provisions for mixtures of substances (preparations) were originally laid down in Directive 88/379/EEC, which was replaced by Directive 1999/45/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations (the Dangerous Preparations Directive or DPD). The vast number of preparations50 in existence makes it uneconomical to classify each of them on the basis of laboratory testing. Since this would also mean in most cases animal tests, animal welfare considerations would further render such a task nearly impossible (or politically and ethically highly controversial). Preparations are therefore normally classified with the help of calculation methods, based on the concentration of the various components of the preparation and their intrinsic hazardous properties established under the DSD. Once the appropriate classification has been established, the DPD uses, in general, the same classes of danger and the same labelling requirements as the DSD. However as is clear from the evidence presented in Box 2.1, while classification, labelling and SDSs may be the most important (and often the only) information sources for downstream users of dangerous substances and preparations, they are in fact far from universally either correct or complete.

implementation of Article 27 of Council Directive 67/548/EEC (safety data sheets) (Text with EEA relevance), Official Journal L 212 ,07/08/2001 P. 0024 - 0033. And under certain circumstances also non-industrial/occupational users. Estimates talk about 2,000,000 and more.

Exposure Limits in the EU 43

1 Box 2.1

Compliance with the provisions for classification and labelling and SDSs at EU level Trade unions and practitioners have frequently suggested that SDSs are seldom the useful and accurate sources of information that they are meant to be. Recent survey evidence supports this view. A report of the ECLIPS (European Classification and Labelling Inspections of Preparations, including Safety Data Sheets) project51 undertaken by the Chemical Legislation European Enforcement Network (CLEEN)52 to assess the extent of compliance with the classification and labelling legislation in Member States found that in practice such compliance was quite restricted. The project focused on the DPD'3 and in particular on preparations classified as dangerous for the environment, and / or classified as carcinogenic, mutagenic and / or toxic for reproduction (CMR), and / or containing substances with sensitising properties, and / or containing substances assigned the Risk Phrase R67.S4 In order to keep the results comparable, it was also decided to focus on a limited number of product groups, i.e. paints and varnishes, cleaning agents (e.g. solvent based), detergents, preparations to be used in construction of buildings and photo chemicals. It found that not more than 40 per cent of the preparations currently on the market, and only 30 per cent of the SDSs complied with legal provisions. The labelling of about 60 per cent of the preparations it examined was incorrect and two third of the SDSs were either incorrect or incomplete.

http://www.cleen-eu.nefprojects/Press_release_ECLIPS.pdf/ http://www.umweltbundesamt.at/fileadniin/site/umweltthemen/chemikalien/ECLIPS_Final _Report.pdf. CLEEN is a network of national chemicals inspectorates that coordinates and improves the enforcement of EU chemicals legislation (enforcement is the responsibility of the Member States). Is central task is the exchange of information between national enforcement authorities and it sets, in collaboration with the Member States, priorities for enforcement projects in the EU. Because most of the chemicals on the market are preparations. Vapours may cause drowsiness and dizziness.

44 Beyond Limits

The Universality of the Requirements. A classification under the DSD and the DPD can have a significant impact on the way in which substances are addressed in other Community legislation, hi at least 60 other pieces of Community legislation, reference is made either to the criteria for hazard identification of the Directives themselves or provisions for additional risk reduction measures at Community level are based on the classification of substances listed in Annex I to the DSD. For example, substances and preparations classified as category one or two carcinogens or mutagens are subject to more stringent control and protective measures at the workplace than other (hazardous) substances and preparations. The provisions for the treatment of waste are based on the hazard classification as well as the provisions under the Seveso Directive on the control of major-accident hazards. Finally, the classification of dangerous substances and preparations can have repercussions on the marketing and use of a chemical (see the following section on Directive 76/769/EEC), ranging from the prohibition of the marketing to the general public to a complete ban of a substance. Dealing with Existing Substances. Recognition of the problem of existing substances led the European Council in 1993 to adopt Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances (Existing Substances Regulation or BSR).This Regulation set the framework for the evaluation and control of existing substances, namely those listed on the EINECS list. Because the number of chemicals listed in EINECS (more than 100,000) was far too big to evaluate, a prioritisation took place at European level primarily based on production volumes55 and on the potential risk to man and the environment, resulting in four lists of about 140 substances of high concern.56 S7 5S 59 Substances on priority lists must undergo an

The Regulation was initially concerned with so-called High Production Volume Chemicals (HPVCs), imported or produced in quantities exceeding 1000 tonnes per year, followed by those of lower volumes (between 10 and 1000 tonnes). Commission Regulation (EC) No 1179/94 of 25 May 1994 concerning the first list of priority substances as foreseen under Council Regulation (EEC) No 793/93 Official Journal NO. L 131,26705/1994 P. 0003 - 0004. Commission Regulation (EC) No 2268/95 of 27 September 1995 concerning the second list of priority substances as foreseen under Council Regulation (EEC) No 793/93 Official Journal NO. L 231,28/09/1995 P. 0018 - 0019.

Exposure Limits in the EU 45

in-depth risk assessment,60 following the framework set out in Commission Regulation (EC) 1488/94" and implemented in the detailed TGD on Risk Assessment for New and Existing Substances.62 A Member State (the so-called rapporteur) is responsible for compiling the data, which is discussed at European level aiming at a consensus on conclusion of the risk assessment amongst the various stakeholders. Before the report and the conclusions are finally adopted and published, it is peer-reviewed by a Scientific Committee officially established at European level. Possible results of the risk assessment for existing substances are; (i) (ii)

(iii)

There is need for further information and/or testing. There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already, There is a need for limiting the risks; risk reduction measures that are already being applied shall be taken into account.

If the risk assessment comes to the conclusion that further risk reduction measures beyond those already in place are necessary, a risk reduction strategy must be developed. Directive 76/769/EEC on the restrictions in marketing and use of dangerous substances is one of the legal frameworks, which could be invoked to manage the risks identified by the risk assessment.

Commission Regulation (EC) No 143/97 of 27 January 1997 concerning the third list of priority substances es foreseen under Council Regulation (EEC) No 793/93 (Text with EEA relevance) Official Journal NO. L 025 ,28/01/1997 P. 0013 - 0014. Commission Regulation (EC) No 2364/2000 of 25 October 2000 concerning the fourth list of priority substances as foreseen under Council Regulation (EEC9 793/93 (Text with EEA relevance) Official Journal NO. L 273,26/10/2000 P. 005-008. Covering the risks to man (covering workers, consumers and man exposed via the environment) and the environment (covering the terrestrial, aquatic and atmospheric ecosystems and accumulation through the food chain). Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) No 793/93 (Text with EEA relevance). Official Journal No L 161,29/0671994, p. 0003-0011. http://ecb.jrc.it/php-bin/reframer.php?B=/TGD.

46 Beyond Limits

Restricting the Marketing and Use of Certain Dangerous Substances and Preparations. Directive 76/769/EEC was introduced in 1976 to deal with situations where classification and labelling of chemicals were not sufficient to protect health and the environment and Member States were introducing national restrictions of the marketing and use of chemicals thus creating barriers to trade. The directive sets out detailed rules for restrictions on marketing and use, harmonising the legislation throughout the Community. It creates a framework for bans or restrictions by means of an Annex, where the controlled substances and/or products are listed. These can only be placed on the market subject to the conditions specified. Two different general concepts of restrictions on marketing and use exist, which can be designated as "ban with exemptions" and "controlled use". A ban with exemptions means that marketing and use of the substances are prohibited except for applications that are explicitly allowed. Controlled use means that marketing and use of a substance and the preparations and products containing it are allowed except those that are specifically forbidden. In practice, the concept of "controlled use" is predominant, i.e. a ban limited to e.g. the general public (e.g. benzidine, chlorinated, hydrocarbons) and/or certain applications (e.g. cadmium). The provisions may be related to concentration limits for the substance in a preparation or a product (e.g. emission limit for nickel in jewellery). There are also requirements for specific labelling and other safety measures (e.g. asbestos). A special mechanism for risk reduction in the Directive, that links the directive with Council Directive 67/548/EEC is provided by the 14th amendment in 1994. This allows substances classified as carcinogenic, mutagenic or toxic to reproduction (category 1 and 2) to be banned for consumer use. The provisions in Directive 76/769/EEC do not cover areas where harmonised legislation already exists, e.g. risks to human health from cosmetics and medicinal products. Before any proposal for measures under Directive 76/769/EEC was made, the Commission consults the various stakeholders and is obliged to present an Extended Impact Assessment (ExIA) on the advantages and drawbacks of such a measure, normally undertaken by an independent consultant.

Exposure Exposure Limits in the EU 47

EUROPEAN LEGISLATION WITH A SPECIAL FOCUS ON PROTECTING WORKERS FROM THE RISKS ARISING FROM HAZARDOUS CHEMICALS In addition to measures that are focussed on the responsibilities of producers to identify and assess the hazards of their chemical products discussed above, there are several instruments amongst the array of regulatory provisions at Community level that are of particular significance for worker protection. They include: Directive 98/24/EC

-

Directive 2004/37/EC Directive 2000/54/EC -

protection of workers from the risks related to chemical agents at work protection of workers from the risks related to exposure to carcinogens at work protection of workers from risks related to exposure to biological agents at work.

As we have already noted, these provisions also need to be understood in relation to the requirements regulation health and safety management generally that are found hi Directive 89/39 I/EEC - the so-called Framework Directive. The Framework Directive 89/391/EEC. The directive sets out the principles for further legislation on workers* safety and health. A number of more specific directives (some fourteen all together) have been adopted with reference to this directive. There are no specific rules regarding chemical agents in the directive. However, Article 6 lists the general principles of prevention. They include: — — -

avoiding risks evaluating the risks which cannot be avoided combating the risks at source adapting the work to the individual, especially as regards the design of work places, the choice of work equipment and the choice of working and production methods, - adapting to technical progress — replacing the dangerous by the non-dangerous or the less dangerous

48 Beyond Limits

— developing a coherent overall prevention policy which covers technology, organisation of work, working conditions, social relationships and the influence of factors related to the working environment — giving collective protective measures priority over individual protective measures — giving appropriate instructions to the workers. The Directive not only establishes a framework of general rules for workers' safety and health protection, but also implemented Europe-wide the concept of a modern, comprehensive approach to occupational health and safety, that should be embedded in the overall management of a company. Individual Directives adopted on the basis of Article 16 (1) of the Directive are all based on the same main principles regulating OHS management but establish, in addition, specific and further going provisions, for example, for: — certain vulnerable groups (e.g. pregnant workers) — special working conditions (e.g. working with computers or on fishing vessels) — particular risks (e.g. chemical agents in general or carcinogens and mutagens in particular) — the design of workplaces and the equipment used (e.g. personal protective equipment). With respect to the protection of workers from chemicals, the three Directives, briefly described in the following, are the most important. Directive 98/24/EEC, sets the frame for preventing the risks from chemical agents in general. Its requirements are outlined below followed by those for carcinogens and for biological agents. The Chemical Agents Directive 98/24/EC. The first comprehensive framework for Community legislation on chemicals in the workplace was included in Council Directive 80/1107/EEC, which set out measures for the control of risks due to chemical, physical and biological agents. It was amended in 1988 by the adoption of Directive 88/642/EEC that focused on the mechanism for setting exposure limits for hazardous chemicals. This directive was repealed on 5 May 2001 with

Exposure Limits in the EU 49

the adoption of Directive 98/24/EEC. Besides Directive 80/1107/EEC,63 a number of other earlier Directives (on metallic lead and ionic compounds (82/605/EEC)64 and Directive 88/364/EEC on banning certain specific agents and/or work activities65 which set the scene for protecting workers from chemical and other risks before the Framework Directive came into force, were also repealed at this time. Directive 98/24/EEC lays down minimum requirements for work with hazardous chemical agents. Its provisions apply without prejudice to the more stringent and/or specific requirements of the Carcinogens Directive 2004/3 7/EC as amended. Here again can be found a link to DSD and the DPD, because the scope of the Directives covers any chemical substance and preparation that either is already classified or meets the criteria to be classified as hazardous in the meaning of those Directives. The Chemical Agents Directive also covers chemical substances which, although they do not meet these criteria, may present a risk to safety and health of workers due to their physio-chemical, chemical or toxicological properties. Importantly for our purposes, it provides a framework for setting occupational exposure limit values and biological limit values at European level. It requires: -

that risks arising from chemical agents are identified by employers through risk assessment that exposure should be prevented or at least adequately controlled that exposure should be monitored regularly in those instances where a national OELV is exceeded, the employer is to remedy the situation through preventative and protective measures. Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work, Official Journal L 327 , 03/12/1980 P. 0008 - 0013. Council Directive 82/605/EEC of 28 July 1982 on the protection of workers from the risks related to exposure to metallic lead and its ionic compounds at work (first individual Directive within the meaning of Article 8 of Directive 80/1107/EEC), Official Journal L 247 ,23/08/1982 P. 0012 - 0021. Council Directive 88/364/EEC of 9 June 1988 on the protection of workers by the banning of certain specified agents and/or certain work activities (Fourth individual Directive within the meaning of Article 8 of Directive 80/1107/EEC), Official Journal L 179 , 09/07/1988 P. 0044 - 0047.

50 Beyond Limits

hi addition: -

workers have to be informed and trained when handling dangerous substances they are subject to regular health surveillance individual exposure record have to be made and kept up-to date employers have to draw up detailed procedures for dealing with accidents, incidents and emergencies that involve hazardous substances.

The principles set out in the Directive (also found in the Carcinogens Directive see below) are based on substitution, prevention, protection and control. Directive 2004/37/EC (as amended). The Carcinogen Directive. Community action on prevention of exposure to occupational carcinogens began in 1990, when the Council adopted Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens at work (sixth individual Directive within the meaning of Article 16(1) of Directive 89/391EEC). This Directive was amended twice,66 and its scope extended to cover mutagens. On 30 April 2004, a consolidated version of the Carcinogen Directive and its amendment was published in the Official Journal (Directive 2004/3767) The Directive has as its main objective to protect workers' health and safety against risks specifically arising or likely to arise from exposure to carcinogens and mutagens at work which meet the criteria for carcinogens and mutagens (category 1 and 2) under the DSD and the DPD. It lays down minimum requirements concerning carcinogens and mutagens, including limit values.

Council Directive 97/42/EC of 27 June 1997 amending for the first time Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC), Official Journal L 179 , 08/07/1997 P. 0004 - 0006. Council Directive 1999/38/EC of 29 April 1999 amending for the second time Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens at work and extending it to mutagens, Official Journal L 138 , 01/06/1999 P. 0066 - 0069. Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version) (Text with EEA relevance) (OJL 158 30.04.2004p. 50).

Exposure Limits in the EU 51

According to the Directive, it is the duty of the employer to reduce the use of a carcinogen or mutagen by replacing it with a substance, preparation or process less dangerous or not dangerous. If it is not technically possible to carry out such substitution, the employer must ensure that the carcinogen is manufactured and used in a closed system. Where neither of these precautions is possible, the employer must reduce the level of exposure to a carcinogen or mutagen to as low a level as is technically possible. Furthermore, the Directive lists a number of measures to which the employer must adhere when a carcinogen or mutagen is used: -

-

-

-

limitation of the quantities of a carcinogen or mutagen at the place of work keeping as low as possible the number of workers exposed or likely to be exposed design of work processes and engineering control measures so as to avoid or minimise the release of carcinogens or mutagens into the place of work evacuation of carcinogens and mutagens at source, local extraction system or general ventilation, all such methods to be appropriate and compatible with the need to protect public health and the environment use of existing appropriate procedures for the measurement of carcinogens and mutagens, in particular for the early detection of abnormal exposures resulting from an unforeseeable event or an accident application of suitable working procedures and methods collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures hygiene measures, in particular regular cleaning of floors, walls and other surfaces information for workers demarcation of risk areas and use of adequate warning and safety signs including 'no smoking' signs in areas where workers are exposed or likely to be exposed to carcinogens and mutagens drawing up plans to deal with emergencies likely to result in abnormally high exposure means for safe storage, handling and transportation, in particular by using sealed and clearly and visibly labelled containers.

The employers shall, when requested, make available to the competent authority appropriate information on:

52 Beyond Limits

-

the activities and/or industrial processes carried out, including the reasons for which carcinogens and mutagens are used the quantities of substances or preparations manufactured or used which contain carcinogens or mutagens the number of workers exposed the preventive measures taken the type of protective equipment used the nature and degree of exposure the cases of replacement.

The employer shall also ensure that workers and/or workers' representatives receive sufficient and appropriate training on the basis of all available information concerning the potential risks to health and the precautions to be taken to prevent exposure, etc. In particular, the employer shall inform workers of installations and related containers containing carcinogens or mutagens, ensure that all containers, packages and installations containing carcinogens or mutagens are labelled clearly and legibly and display clearly visible warning and hazard signs. Reinforced health surveillance is foreseen and the practical recommendations for the health surveillance are given in Annex II. Annex III sets limit values on the basis of the available information, including scientific and technical data. At present, Annex III includes only limit values for benzene, vinyl chloride monomer and inhalable hardwood dust. Directive 2000/54/EC (as amended), The Biological Agents Directive. Although it is not of particularly direct relevance to the subject of this account, the third element of the triumvirate of important Community measures with special significance for protecting workers against hazardous chemicals is the Biological Agents Directive. On 17 October 2000, a consolidated version of the Directive and its amendment was published in the Official Journal (2000/54/EC68). It covers the protection of workers from risks related to exposure to biological agents. Biological agents include micro-organisms, cell cultures and human endoparasites that may be able to provoke infection, allergy or toxicity. They are classified into four groups according to their level of risk of infection. It prescribes measures to Directive 2000/54/EC of the European Parliament and the Council of 18 September2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/39 I/EEC).

Exposure Exposure Limits in the EU 53

be taken to avoid risks and dangers resulting from work with biological agents such as equipment, hygiene, handling of agents, reduction of exposure, vaccination of employees etc. An annex contains a classification of organisms.69

OEL SETTING AT THE EUROPEAN LEVEL Since the central focus of this book is on the determination and use of OELs, arrangements at the level of the EU are clearly of particular interest. As noted above, directives such as the Chemical Agents Directive that have a special focus on risk management strategies for hazardous substances in relation to workplaces make provisions for OELs. To appreciate the significance of these provisions it is helpful to first outline the institutional development of approaches to these issues at the level of the EU. Approaches in the past. The objective of setting OELs in the European Union (EU) was introduced into EU legislation by Council Directive 80/1107/EEC, as amended by Directive 88/642/EEC.70 Under this Directive, two types of OELs were defined, binding limit values and indicative limit values (ILVs). Member States were asked to take the ILVs into account when establishing national OELs, but there was no legal obligation to do so. In 1990, at the request of the European Council, the European Commission set up an informal group of scientists, known as the Scientific Expert Group (SEG), to give advice on setting limit values, after having reviewed the different approaches in the Member States. In 1991, the first set of 27 ILVs was proposed by the EC and agreed by Member States on the basis of pre-existing national positions (Directive 91/322/EEC).71

http://agency.osha.eu.int/publications/factsheets/41/en/FACTSN41-EN.PDF. Council Directive 88/642/EEC of 16 December 1988 amending Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work, Official Journal L 356 , 24/12/1988 P. 0074 - 0078. Commission Directive 91/322/EEC of 29 May 1991 on establishing indicative limit values by implementing Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work, Official Journal L 177 , 05/07/1991 P. 0022 - 0024.

54 Beyond Limits

In 1995, the status of the SEG was formalised, becoming the SCOEL.72 Today the committee has 21 members from all Member States7* with full scientific expertise needed for this task.74 The SCOEL provides the Commission with recommendations on 'health based' OELs. Based on those recommendations, a second list of ILVs was published in 1996 (Directive 96/94/EC).75 Current approaches and types of OELs. With the introduction of the Chemical Agents Directive in 1998, the concept of OELs changed. In Article 3, the Directive introduced: -

Indicative Occupational Exposure Limit Values (IOELVs) Binding Occupational Exposure Limit Values (BOELVs) Binding Biological Limit Values (BBLVs).

IOELVs are supposed to be health based, whereas BOELVs take technical and / or economical feasibility considerations into account. With respect to the IOELVs, Member States had no longer an option whether or not to take them into account. They now have to set a national exposure limit value to implement the IOELV. They can however — under certain conditions - exceed at national level the value of the OEL set at Community level.

95/320/EC: Commission Decision of 12 July 1995 setting up a Scientific Committee for Occupational Ejqsosure Limits to Chemical Agents , Official Journal L 188 ,09/08/1995 p. 0014-0015. The Commission appoints these members after consulting the respective Member States, having regard to the need to cover all relevant aspects of the committee's work. The term of office for SCOEL members is three years and their names are published in the Official Journal of the European Union. Meetings of the committee normally take place four times a year and individuals with particular expertise in the subject under study are sometimes invited to participate. The SCOEL comprises experts in chemistry, toxicology, epidemiology, occupational medicine and industrial hygiene and has general competence in setting OELs. Commission Directive 96/94/EC of 18 December 1996 establishing a second list of indicative limit values in implementation of Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (Text with EEA relevance), Official Journal L 338 , 28/12/1996 P. 0086-0088.

Exposure Limits in the EU 55

For any chemical agent for which a binding value is set at Community level, Member States have to set a corresponding national binding value. The national binding limit value can only be stricter, but cannot exceed the Community limit value. A first list of IOELVs was established in Commission Directive 2000/39/EC of 8 June 2000.76 Procedures and bodies involved. The SCOEL starts its work by evaluating criteria documents from different sources. The Commission, through publication in the Official Journal, announces the identified base document with the request for further data, especially that which is unpublished, to be provided to the Commission, to guarantee the completeness of the data for the chemical agent concerned. The SCOEL evaluates the scientific dossier and the supplementary data for the identification of the critical health effects and then proposes a recommendation for a health-based limit value in a summary document, which in addition to the recommendation for an OEL, also contains further information on the basic data, a description of the critical effect, the extrapolation techniques used, and any data on possible risks to human health. The technical feasibility of monitoring exposure is also noted. Furthermore the SCOEL identifies important gaps in the data and the need for more research. Once the Committee agrees the summary document the Commission makes it public to interested parties with the request for health based scientific comments and eventually further data. After a period of about six months allowed for comments, the SCOEL rediscusses the document in the light of the comments received and adopts the final version, which is then published by the Commission. When the Commission services have received recommendations from the SCOEL they are in a position to develop legal proposals for OELs. At this stage and according to the type of OEL, the Commission services will seek relevant technical and socio-economic data. If any of the interested parties is aware that there are such data which can be shown to be pertinent to the development of a

Commission Directive 2000/39/EC of 8 June 2000 establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work (Text with EEA relevance), Official Journal L 142 , 16/06/2000 P. 0047 - 0050.

56 Beyond Limits

Commission's proposal then these should be made known to the Commission services. The Commission's proposal for a legislative text is submitted to the Advisory Committee for Safety, Hygiene, and Health at Work, (ACSHH), a tripartite committee consisting of representatives from governments, employers' organisations and trade unions. At this stage all the interested parties have a further opportunity, through the ACSHH structure, to contribute to the opinion adopted by the Committee. The opinion delivered by the ACSHH is available through its minutes and is also published in the ACSHH's annual report. Once these consultations have been completed the Commission services will finalise their preparation of a proposal to be agreed by the Commission. According to the type of OEL (binding or not binding) and the legal procedure selected, further consultation on the Commission's proposal, within the appropriate European Union institutions, will take place, before the final adoption and publication in the Official Journal of an OEL.77

EFFECTIVENESS OF THE EXISTING LEGISLATION AND THE FUTURE APPROACH AT COMMUNITY LEVEL Despite the quantity and detail of existing provisions at Community level, effective risk management of hazardous substances and preparations at Community and national level is far from guaranteed. Indeed, there is widespread recognition that its regulatory instruments have turned out to be fairly inefficient in particular because the processes they invoke are operationally time consuming and because they set different risk assessment obligations for so-called new and existing substances they have resulted in substantial data gaps for the majority of substances78 marketed in Europe.

OELs are measured or calculated for a reference period of eight-hour time weighted average (TWA). For a number of substances, short-term exposure limit values (STEL) are also given, representing a limit value above which exposure should not occur and which is related to a 15-minute period, unless otherwise specified. They are expressed either in mg/m3 of air at 20 °C and 101,3 KPa or in ppm. In addition, a skin notation can be assigned to the OEL, indicating the possibility of significant uptake through the skin. Most of the estimates speak about 99 per cent.

Exposure Limits in the EU 57

A Commission report on the operation of the main instruments was published in 1998,79 leading to the conclusion that the existing legal framework was not adequate (CEC 1998). As a consequence, the Commission developed its White Paper on a Strategy for a Future Chemicals Policy, which was adopted in 2001. It argued:80 -

There is a lack of knowledge about the dangers of many chemicals on the EU market. This makes it difficult to assess their risks properly and to make informed decisions about controlling those risks.

-

The current process of risk assessment is much too slow. Only a handful of chemical substances are assessed at EU level each year.

-

Resources are concentrated too much on the assessment of "new substances" which make up less than 1 per cent of the total volume of substances on the market and not enough on "existing substances". This has the effect of stifling innovation in new chemical products.

In May 2003, after additional impact studies and various discussions at Council level and with different stakeholders, the Commission published a draft proposal that was then subject to consultation resulting in more than 6,000 Stakeholder Representations including those from Member State Governments, Competent Authorities, the Chemicals Industry and other interested parties. Following the consultation, the Commission adopted a proposal for the 'Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals' otherwise known as REACH. It modified several of its initial requirements in what several commentators have seen as concessions to a powerful industrial lobby (Epstein 2005). The legislative proposal was put before the European Parliament and the Council where it remains subject to intensive discussions.81 http://eviropB.eu.int/coniin/eiivironni8nt/cheinicals/pd&report-4-instiuiBents_en.pdfi'. Commission Working Document: Report on the operation of Dir, 67/548, Dir. 88/379, Reg 793/93 and Dir. 76/769. http://europB.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEX numdoc&lg=EN&aumdoo=52001DC0088&model=guichett. The Commission proposal is subject to the co-decision procedure.

58 5 8 Beyond BeyondLimits him its

The main element of the new Regulation as proposed by the Commission can be summarised as follows:82 REACH will replace the main pieces of European chemical legislation by an integrated system. It will eliminate the current distinction between 'existing' and 'new* chemicals and their respective testing requirements.83 In outline it consists of several interlinked requirements on chemical producers concerning the registration, evaluation and authorisation of their chemical products. They are: (1) Registration - Registration requires all chemicals manufactured in or imported into the EU in a volume of 1 tonne or more per year to be registered with the competent authority within a new European Chemicals Agency (ECA). The ECA will manage a central, EU-wide database. - Companies will have to submit basic information including a brief description of the uses of the substance and any uses that the manufacturer advises against84, as well as a technical dossier of test data and future testing proposals. - Data requirements vary according to the production volume and suspected toxicity of the substance. - Registration will be undertaken in several stages, with deadlines varying with production volumes: - Substances supplied in excess of 1,000 tonnes a year and some substances of so-called 'high concern' (e.g. CMRs,85 PBTs,16 or vPvBs87) will be registered within 3 years of the law coming into force - those in excess of 100 tonnes within 6 years - those in excess of 1 tonne and 10 tonnes within 11 years. - For chemicals that raise no particular concerns or annual production of which usually remains below a ceiling of 100 tonnes, registration will be 82 83

http://europa.eu.int/comin/entBrprise/reach/. Certain chemicals are exempted from the proposals; these include polymers, intermediates in chemical processes that never leave the factory, pharmaeeuticals a n d foods. If a company wishes to employ a chemical for an unregistered use the registration dossier must be updated to reflect this. Substances being carcinogenic, mutagenic or toxic to reproduction. Substances being persistent, bioaccumulative and toxic. Substances being very persistent and very bioaccumulative.

Exposure Limits in the EU 59

sufficient. All substances produced or marketed in greater volumes, or which are more sensitive, will be subject to evaluation. (2) Evaluation - National authorities on the basis of the registration data will undertake evaluation. Two types of evaluation are proposed: - Dossier evaluation - all registrations that propose further animal tests will be evaluated to ensure that such tests are strictly necessary. The evaluation process checks if test data for the substance in question are already available, and whether alternative tests could be employed to prevent unnecessary animal testing. - Substance evaluation - carried out if a competent authority suspects that a substance poses a risk to human health or the environment (for example because of its structural similarity to a known dangerous substance). This involves examining the dossiers of all registrations for a substance to clarify the risks and may result in the authority requesting further information from those registering the substance. (3) Authorisation - Substances identified through registration and/or evaluation as being of high concern (CMRs, PBTs, vPvBs) cannot be used or placed on the market without authorisation. Authorisation will be granted to the producer / importer of a substance only (one for each use and user) if they can demonstrated that they can control, in an appropriate way, the risks posed by the chemical or that the socio-economic benefits of the substance outweigh the risks. This type of decision may take into account whether industry is actively researching to find an alternative substitute. Authorisations granted for socio-economic reasons will be time-limited and reviewed on a case-by-case basis. The use of other substances that pose unacceptable risks, but are not classified as of high concern, could be restricted if requested by a Member State. Restriction may ban use in certain products, by consumers, or even any use at all.

60 Beyond Limits

REACH AND WORKER PROTECTION In summary, it is intended that the measures in REACH will increase the effectiveness of existing provisions to protect workers exposed to dangerous substances and combat risks of ill-health caused by work-related exposure to chemicals by: -

-

providing information that is currently not available on the properties of chemical substances and ways of minimising the risks associated with using them improving the communication of such information throughout production and supply chains promoting substitution of the most harmful chemicals with less hazardous ones by means of its authorisation and restriction provisions.

The extent to which this will actually occur however depends on several issues for which the prognosis is at present unclear. Partly because of this, REACH has generated considerable debate. For the social and economic interests involved this debate has been polarised around issues of costs versus benefits, with the former being emphasised by industry and the benefits for human health and the environment championed by social interest groups such as environmental NGOs and most of the trade unions.88 The assumptions made by or on behalf of all the interest groups involved regarding such costs and benefits, coupled with the additional problem that it is as yet unclear what form the final implementation of the regulation will take, or how it will work in practice, make it very difficult to predict outcomes either with regard to workers" protection in general or the particular future for OELs in this process. Nevertheless some things seem clear. First, while the requirements in REACH will undoubtedly contribute to increasing knowledge and information concerning the hazardous properties and safe use of far more chemicals in use in Europe than is currently the case, the extent to which the communication of such information and its usefulness in practice will be enhanced by the Regulation is less certain. The policy rhetoric behind REACH places considerable emphasis on not only how the measures will involve greater requirements on chemical producers to exercise responsible stewardship of their products, but also how such duties will

See for example Musu (2004).

Exposure Limits in the EU 61

extend though the supply chain with the result that formulators and users will also be bound to engage in a far more active way in ensuring the safety of chemical substances than is currently the case. However, such reasoning seems to be based on a particularly optimistic way of looking at how supply chains actually operate in relation to health and safety of workers as well as on a fairly limited assessment of what prevents users from either understanding or using the information on the safe use of chemicals that is currently available. These are issues to which we will return in our discussion in the final chapter of this book, but it is sufficient to note that the existence of business networks for production, supply and demand do not automatically lend themselves to a role in enhancing health and safety - indeed in some cases they owe their existence to attempts by business organisations to off-load responsibilities for health and safety.89 Furthermore, current research findings on risk communication in relation to chemical hazards suggest that user's understanding and use of safety information is the result of a more complex set of factors than merely the failure to supply the information in the first place.90 This is of course especially important in relation to the role of OELs in risk management strategies at the workplace level. Again, we shall return to this discussion in the concluding chapter of this book. A final point is that (at least as far as the current proposal is concerned) REACH will probably have little immediate effect on the current situation at the work places with regards to OELs, because test requirements on suppliers in REACH are based on the annual production or importation volume of a substance and for substances between 1 and 10 tonnes they will not - for the reasons outlined in Chapter 1 - allow the development of OELs for substances which don't already have one. This might change in the long term, after all substances have been registered and the data evaluated.

For example business organisations frequently out-source both services and goods to wider supply networks in attempts to reduce the costs of these functions to their core organisation. See for example, the findings of the recent ECLIPS (2004) study in the light of British based research findings such as those of Briggs (2000); Kigston-Howlett (2001); Wiseman and Gilbert (2002)and Middlesex University Business School,(2004) that will be discussed further in ChapterlO.

62 Beyond Limits

CONCLUSION It should be evident from the preceding pages that there has been a substantial system for regulating risk management of hazardous chemicals in place at the level of the EU for some considerable time. It emanates from two overlapping sources, one that deals with trade and the other for the protection of workers. The system is based upon sound prevention principles, including those of hazard identification, risk assessment and communication as well as principles of safe practice that emphasise substitution and control at source and is vested with sufficient authority to deem certain substances too dangerous to be marketed unless under strict and specified conditions. The outline presented here demonstrates how regulating the risks from occupational exposures to hazardous chemicals forms a special part of this system overall and needs to be understood in this context, as well with reference to other measures regulating health and safety management such as those in place in all member states as a result of their transposition of the Framework Directive 89/391. Structures and procedures for setting exposure limits at EU level have developed as part of this subsystem for regulating chemical risks in relation to the workplace. However, the current view of the existing system is that its burgeoning regulatory requirements are failing in the degree to which they could be deemed to be effectively operational and contributing significantly and cost effectively to minimising the risks to health and the environment posed by hazardous substances at work, in consumer products and elsewhere in the environment. As a consequence, a new regulatory strategy is under discussion and likely to become effective in whole or in part over the coming decade. As we have indicated, it is unlikely that the immediate effects of the new strategy on the position and role of OELs will be particularly significant. However the thinking behind it is important and several aspects of the new proposals and the assumptions on which they are based could be particularly significant in relation to managing risks associated with hazardous substances in the medium to longer term. This is especially so in relation to the position of users of chemicals in small and medium sized enterprises where, as we shall see in subsequent chapters, the failures of existing provisions in relation to the role of OELs have been felt most acutely. We will return to this discussion in our concluding chapter, which follows the detailed exposition of the extent of the problem presented in the country chapters later in the book. Before doing so it is necessary to consider the position of OELs

Exposure Limits in the EU 63

in the legislative systems of the EU 15 countries, the extent to which such positions are comparable and the effects that approaches to OELs at the level of the EU have had on them. It is to these issues that we turn in the following chapter.

This Page is Intentionally Left Blank

65

SYSTEMS FOR SETTING AND USING OCCUPATIONAL EXPOSURE LIMITS IN EU15 COUNTRIES

INTRODUCTION

This chapter continues our analysis of the nature and role of requirements on setting and using OELs within regulatory systems that we started in Chapter 2 in relation to European Community institutions. In the present chapter however we are concerned with the position at the level of the member states, and specifically with that in the EU 15 member states. The primary intention here is to document comparable and distinguishing features of the various national level institutional and legislative frameworks in which exposure limits are developed and used. To these ends a considerable amount of detailed information on different national structures and systems was gathered, both in the original research project on which the book is based (Walters et al 2003) as well as more recently in updating that material and adding to it new elements. The main aspects of the various systems for setting and using OELs have of course not changed within the last two years. However, there have been changes to the lists of OELs in some countries as well as to many of the Internet links identified in the previous published report (Walters et al 2003). Also significant for accurate documentation of national systems is the tendency to reshuffle responsibilities within governments after an election, resulting in changes in the ministries responsible for the establishment of occupational health and safety legislation in general and for publishing/issuing the OELs in particular. We have therefore attempted to reflect these changes in the current chapter. We believe it to be a fair snapshot, but it is important to caution

66 Beyond Limits

that the details of the administrative and regulatory systems described here are subject to continuing change. In order to avoid cluttering the text with too much detail, to maintain clarity in terms of highlighting major points of comparison and difference, and for ease of reference to the material itself, much of this information has been presented in tabular form. In addition, further relevant information in tabulated in Annexes I to IV that can be found at the end of the book." The tables presented in the following pages and in the related annexes therefore outline current information, that while not essential for the understanding of the principles behind the development and operation of various systems they describe, provides the necessary tools to dig deeper into the subject, if this is required. The chapter begins with an overview of the institutional framework regulating occupational health and safety in each of the EU 15 countries. This is followed by an outline of the basic legislative frameworks governing occupational health and safety generally, and chemical substances specifically, in each country. This information is supported by further material on responsible institutions and on the transposition of EU provisions into national laws in the EU 15 countries in Annexes I, n and III. The chapter continues with the tabulation of comparative aspects of the features of systems for setting limit values, including the main types of limit values set, their origins, the number in each country, notations used, the frequency with which they may be updated and other relevant information for all the EU 15 countries. This is followed by a tabulated comparison of the procedures for setting exposure limits in each country, including the involvement of social partners and other bodies in these processes. We outline the systems for enforcement and surveillance of compliance with OELs in each country. Finally we conclude the chapter by identifying and briefly discussing some of the main issues concerning the role of OELs in national systems. These issues will be pursued in greater depth in subsequent chapters on the six countries that are the subject of our detailed study.

Additional details can also be found in Walters et al (2003), the published research report of the original study on which this book is based.

Occupational Exposure Limits in in the EU 67 67 Occupational

REGULATORY SYSTEMS AND RESPONSIBLE BODIES Table 3.1 gives an overview on the institutional framework for occupational health and safety in each country. It lists the: -

responsible ministry and its sub-department(s) scientific and / or other bodies and institutions involved in developing OELs at national level authorities responsible for surveillance and enforcement.

Names are only provided in English where translation was provided in one of the official or semi-official documents and websites used for compiling the data. In all other cases, the original name has been kept. Relevant web-site addresses where they exist for the ministries and the other bodies and institutions mentioned below are listed in Annex I (Websites of Ministries and other bodies involved in H&S).

68 Beyond Limits ON

00

Table 3.1:

National institutions with responsibilities for developing occupational exposure limits for surveillance.

Country

Ministry

Sub-Department(s)

Austria

Federal Ministry of Economics and Labour Le Service public federal Emploi, Travail et Concertation sociale (SPF) Ministry of Employment

Department III - Labour Law and Labour Inspectorates Direction generate Controle du bien-etre au travail Division du controle des risques chimiques

Ministry of Social Affairs and Health

Occupational Safety and Health Department

Belgium

Denmark

Finland

Working Environment Authority

Scientific and other bodies / institutions involved Arbeitnehmerschutzbeirat

Surveillance Authority Central Labour Inspectorate Inspection du Travail et des mines

National Institute of Occupational Health; Working Environment Council and its Committee on Limit Values Advisory Committee for Occupational Health and Safety on Chemicals; Finnish Institute of Occupational Health

Working Environment Authority

Occupational Safety and Health Inspectorates

Ministry

France

Ministere de I 'Emploi, Secteur emploi / travail du Travail et de la Direction des relations du travail Cohesion sociale

Germany

Federal Ministry of Economics and Labour

Greece

Ireland

Ministry of Employment and Social Protection Ministry of Health and Welfare Minister for

Sub-Department(s)

Federal Institute for Occupational Safety and Health (Bundesanstalt fiir Arbeitsschutz und Arbeitsmedizin)

General Directorate of Working Conditions and Health; Centre of Occupational Health and Safety Health and Safety Authority

Scientific and other bodies / institutions involved Conseil superieur de la prevention des risques professionnel; Institut National de Recherche et Securite Caisse nationale de I'Assurance Maladie des travailleurs salaries Regional Offices for Industrial Safety (Landesamter fur Arbeitsschutz); Institutions for statutory accident insurance and prevention for trade and industry (Berufsgenossenschaften); Committee for Hazardous Substances (Ausschuss fur Gefahrstoffe)

Surveillance Authority L 'inspection du travail

Trade Supervisory Offices (Gewerbeaufsichtsdmter) Technical Inspection Services (Technische Aufsichtsdienste)

National Council for Health and Soma Epitheorisis Safety at Work; National Health Ergasiss (Joint State and Safety Institute Technical Inspectors)

Advisory Committee on

Health and Safety

Occupational Exposure Limits in the EU

Country

I I

3

69

70 Beyond Limits -J

o

CO

Country

Italy

Ministry

Sub-Department(s)

Enterprise, Trade and Employment Ministero della Sanita Ministere del Lavoro e delle Politiche Sociali

Luxembourg Ministere du Travail etdul'Emploi Portugal Ministeria do Trabalho e da Solidartedade

Scientific and other bodies / institutions involved Dangerous Substances

Surveillance Authority Authority's inspectorate

Istituto Superioreper la Ispettorato del Lavoro Prevenzione e la Sicurezza del Lavoro; Istituto Superiore di Sanita; Commissione consultiva tossicologica nazionale; Instituto Nazionale per L 'Assicurazione contra gli Infortuni sul Lavoro Istituto Italiano di Medicina Sociale; Commissions consultiva permanente per la prevenzione degli infortuni e I'igiene del lavoro

Direccao-General das Condigiones de Trabalho — DGCT

Instituto para a Seguranca, Higiene e Saude no Trabalho

L'Inspection du Travail et des Mines Inspecgao Geral do Trabalho-IGT

I

Ministry

Spain

Ministerio de Trabajo Commission Nacional de y Asuntos Societies Seguridad y Salud en el Trabajo (Ministry for Labour and Social Affairs) Ministry of Industry, Swedish Work Environment Employment and Authority Communication Ministerie van Sociale Directoraat-Generaal Zaken en Arbeidsverhoudingen en Werkgelegenheid Internationale Betrekkingen

Sweden

The Netherlands

United Kingdom

Department of Work and Pensions

Sub-Depart nient(s)

Health and Safety Commission/Health and Safety Executive

Scientific and other bodies / institutions involved Instituto Nacional de Seguridad e Higiene en el Trabajo

Surveillance Authority Inspection de Trabajo

Swedish National Institute for Work Environment Working Life; Swedish Criteria Inspection Department Group Health Council of the Labour Inspectorate Netherlands Expert Committee on Occupational Standards DECOS; the Social and Economic Council Sub-Committee on MAC values of the Social and Economic Council Advisory Committee on Toxic Substances (ACTS)

Health and Safety Executive

Occupational Exposure Limits in the EU

Country

§•

•3

I

71

72 Beyond Limits

IMPLEMENTING EU REQUIREMENTS IN EU15 MEMBER STATES All EU 15 Member States claim to have transposed relevant European legislation dealing with occupational health and safety in general and with hazardous chemicals in particular into national legislation. However, some indication of the extent to which this is a reality is provided by the annual reports of the Commission monitoring the application of Community law.*2 According to the most recent of these reports for example, a decision has been taken to refer France and Italy to the European Court of Justice because they have not yet notified measures transposing Directives 98/24/EC and 2000/39/EC respectively. Moreover, following the judgment given by the Court of Justice against Austria for failure to notify Ml measures transposing Directives 95/30, 97/59 and 97/65 (risks of exposure to biological agents at work), Article 228 proceedings are in motion as regards the first two directives. Several infringement proceedings have also been commenced or continued regarding problems of incorrect transposal of the Framework Directive 89/39 I/EEC and its specific directives. Reasoned opinions were sent to Austria, France and Spain regarding the transposition of this Directive. Proceedings are also still in motion against Ireland, Sweden and the United Kingdom and the cases against the Netherlands and Luxembourg have reached the Court of Justice. On 7 February 2002 judgment was given against Germany for incorrect transposal of the obligation imposed by the directive for a health and safety risk evaluation to be available in documentary form at all times. When European Directives dealing with the protection of workers from risks arising from hazardous chemicals have been transposed into national legislation, in most cases they have been integrated into existing national chemicals legislation. The Framework Directive 89/3 9 I/EEC, however, which was somewhat of a milestone in health and safety legislation at European level, provided for so many obligations for all stakeholders that in many countries a separate law was needed to transpose it into national legislation.93

See for example, the 20th Annual report on monitoring the application of Community law (2002), Brussels 21.11.2003, COM(2003) 669 final http://europa.eu.int/eurlex/en/com/rpt/2003/ actO669en03/l.pdf, For details see Walters et al 2002 and also Vogel 1993 and 1998.

Occupational Exposure Limits in the EU 73

In addition, in all countries there is legislation (either as an individual enactment or as part of another piece of legislation) that transposes EU directives on: -

carcinogenic and rnutagenic substances in general and on asbestos in particular biological agents lead and vinyl chloride monomers banning certain substances / work procedures94 safety data sheets95 occupational exposure limit values.

In Annex If an overview on the transposition in each country of the main pieces of European legislation dealing with hazardous chemicals and workers protection is provided. In Annex HI, are found the names and the source of the basic legislation, transposing the Framework Directive (89/39 I/EEC), the Chemical Agents Directive (98/24/EC), and the Carcinogen Directive (2004/37/EC) into national law in each country. A Unk to a web page where the most recent OEL list can be found is also provided (if existent).

OCCUPATIONAL EXPOSURE LIMIT VALUES IN THE EU IS COUNTRIES Table 3.2 compares the various Emit value lists from each country in terms of: 94

95

acronyms and names/types (health based/economically-technically based) of OEL listed source of OELs (own system or based mainly on other systems like the US, the German or Nordic systems) information given on forms of notations etc. number of substances listed

Transposition o f Directive 88/364/EEC banning o f certain agents and activities (01.01.90) repealed by 98/24. The Directive on Safety data Sheets as amended has a different legal basis than the other Directives on health and safety. Nevertheless, this Directive is an important tool for providing information on hazardous chemicals at the workplace, and it is therefore listed here.

74 Beyond Limits -

other information provided regularity of updates (yes or no/last update).

In general, all OELs are established for single substances96 and fulfil the following requirements. Their underlying basic assumptions are that they are established for healthy people of employable age. Definitions for OELs include those for: -

Health-based OELs. "Maximum allowable concentration in the workplace / in the breathing zone of a worker of a working material in the form of gas, vapour, or air-suspended matter which, according to the present state of knowledge, generally does not impair the health of the workers even through repeated and prolonged exposure."

-

Technically/economically based OELs. "Concentration of a dangerous working material in the form of gas, vapour, or air-suspended matter in the air at the workplace, which can be achieved according to the state of the art in technology/the best available technology.

-

Biological limit values. Maximum value for the content of the substance or of one of its metabolites in biological media (i.e. blood, urine).

There are three different kinds of units in which the OEL concentrations are presented: -

-

ppm (number of cubic centimetres of pollutant per cubic metre of air — independent from temperature and air pressure), for gases and vapours (volatile substances) mg/m3 (milligrams of pollutant per cubic metre of air) at 20°C and 101.3 hPa for non-volatile substances and airborne particles Fibres/m3 for substances that occur as airborne fibres (e.g. asbestos).

There are several reference periods for which OELs may be established (if they are established) that are commonly used. They include: -

TWA: time-weighted average, for a shift average of normally 8 hours daily, in an average weekly working-time of 40 hours" Provisions on how to deal with mixtures are described in the lists.

Occupational Exposure Limits in the EU -

-

75

STEL: Short-term exposure limit values measured over a duration of maximum 15 minutes, normally only allowed for a maximum of one hour within the 8hour period C; Ceiling values98 - STELs that must not be exceeded at any time.

Most lists and/or the relevant legislation contain: -

notations for skin provisions on how to deal with mixtures.

Fca: a 4-shift-premise, the basis is 42 hours per week on average for four consecutive weeks. Normally established for substances which are so fest-acting that the level of exposure to them can never be permitted to exceed the limit value.

Country

notations etc

other information

"S" (and sub-groups) for sensitising

Provisions on how to

- ACGIH / German MAK Commission. Currently own system in place

substances "H" for substances, which can penetrate the

calculate the OELs for mixtures

- MAK list: ~ 700 main entries102 plus ~ 540 entries for synonyms of the main entries; = 210 of these

skin easily

Provisions for specific (groups of) substances

Type, origin, number and frequency of updating OELs - MAK;99 TRK100

Austria

101

entries are referring to either Annex II (TRK list) or Annex III (carcinogens) or both Annexes - Yes (2003) Belgium

99

100 101 102

103 104 105

(carcinogens, volatile substances, wood dust etc.)

- VLEP;103 VLB104

A - for substances which release a gas

Provisions on how to

- Principally based on the US ACGIH list of 1993105 and the EU lists of OELs - = 670 entries (no entries with synonyms etc); = 100 entries for carcinogens & mutagens

which is not toxic but reduces the amount of oxygen in the air C - recognised carcinogens or mutagens D - risk of absorption of the substance via

calculate the OELs for mixtures

Maximale Arbeitsplatzkonzentration - Maximum Workplace Concentrations. Technische Richtkonzentrationen -Technical Guidance Concentrations. American Conference of Governmental Industrial Hygienists. Individual substances or group entries either specifying the individual substances within the group entry or like xyz and its salts or xyz compounds or xyz and its compounds. Valeurs limites d'expositionprofesionnelles — professional exposure limit values. Valeurs limites biologiques - biological limit values. Information given by the Belgian member of the SCOEL and the representative of the Belgian Government in the AHG Limit Values.

76 Beyond Limits

Table 3.2 Some common features of OEL terminology in EU 15 country lists

<5

Country

Type, origin, number and frequency of updating OELs

notations etc

- No clear structure for a systematic revision (2003)

other routes than inhalation (via skin, the

other information

eyes or by swallowing) F - exposition occurs in the form of fibres M - risk of irritation or acute intoxication Denmark

"H" for substances known to be capable of uptake via the skin "K"110 for carcinogens "L" for substances that have been assigned a ceiling value

At least every two years (2002) Finland

112

- sitovat raja-arvot; values.114

HTP -arvot;

Organic solvents are given a specific list of limit values111 Provisions on how to calculate the LV for mixtures. Particular provisions for dust

113

biological limit

skin notations ("Skin" or "Iho")

Provisions on how to calculate the limit values

Limit Value — legal status: administrative instructions. Biological Exposure Value. SCOEL (EU), ACGIH (US), MAK (Germany), DECOS (Netherlands) and Nordic Expert Group (NEG). Individual substances or group entries either specifying the individual substances within the group entry or like xyz and its salts or xyz compounds or xyz and its compounds. Krceftfremdkaldende. /fttp://www.arbejdstilsynet.dk/graphics/at/engelsk-pdf/at-vejledninger/gvlisteuk.pdf. Legal status: binding limit values, exeeding them obliges the employers to take immediate actions for lowering the exposure level.

Occupational Exposure Limits in the EU

LV;106 BEV107 Own system in place but using criteria documents developed by other scientific bodies108 ~ 700 entries109 plus ~ 340 entries for synonyms of the main entries; ~ 330 entries for organic solvents; ~ 600 entries for carcinogens

8 a

I

I <5

77

Type, origin, number and frequency of updating OELs

notations etc

other information for mixtures

system in place. — ~ 500 substances of which ~ 40 are group entries, specifying about 200 additional individual substances. The binding limit values are identical with those established at EU level.115 - Regularly (at least every two years) -

VLEP; 116 VL;' 17 VR; 118 IBE 119

- Limit Values recommended by the CNAM — Own scientific and committee review system in place. ~ 550 main entries and ~ 90 entries for synonyms of the main entries; = 80 entries

114

Differentiation between CMR120 substances according to the classification in Annex I to Directive 67/548/EEC general or specific allergic risks121 related to the substances are indicated

Reference to the recognised occupational disease related to a substance. Additional information on standards

Haitalliseksi tunnetut pitoisuudet - legal status: orientation values, but have to be taken into account by the employers for risk management measures. Have to be taken into account when assessing exposure of workers.

115

e.g. for asbestos, benzene, venylchloride monomers etc.

116

Valeurs limites d'exposition professionnelle. Valeurs limites admises — indicative, are considered as minimum objectives.

117 118

Valeurs limites reglementaire - mandatory 8established for asbestos, benzene, venylchloride, lead, silica, wood dust and inhalable and respirable dust).

119

Indicateurs biologiques d"exposition.

120

Carcinogenic, mutagenic and toxic to reproduction. Related to the route of exposure.

121

oo Co

- Originally based on US ACGIH list, now own

France

78 Beyond Limits

-J

Country

I

Country

Type, origin, number and frequency of updating

notations etc

other information

OELs identified as CMRs - Revised regularly based on new available data.

for measurement techniques. Provisions on how to calculate the LV for mixtures

Germany

"H" for substances which might be

Special provisions on

- since 1 Jan. 2005: AGW;125 TGW126 - Own system in place, but also using meanwhile OELs established in other countries, the origin127 of which is indicated in the list. MAK-list ~ 670 main entries of which ~ 65 are group entries128, covering more than one substance, about 80 of these entries are TRK. values. BAT-list = 50 entries; CMRs12* « 160 entries and group entries

absorbed via the skin "Y" for substances for which a developmental risk is not to be expected if the Bruit value is respected

how to deal with hydrocarbon mixtures, dieses engine emissions, different types of fibres or dust provisions on how to calculate the OELs for mixtures

Maximale Arbeitsplatzkonzsntrationen (Maximum Workplace Concentrations). Teehnische Richtkonzentrationen (Technical Guidance Concentrations), Biologische Arbeitsstoffiolercmzwerte (Biological Tolerance Value for occupational exposures). Arbeitsplatzgrenzwerte (workplace limit values). Teehnische Qrenzwerte (technical
Occupational Exposure Limits in the EU

- Until 31 Dec. 2004: MAK;122 TRK;123 BAT124

8 a

I

I <5

79

Type, origin, number and frequency of updating

notations etc

other information

OELs - AnnuaEy (2004) Greece

- OELs;130BLVs131 - ACGIH. EUlistoflOELVs — ~ 560 substances with indicative OELs — No clear structure for updates

Skin notation

Ireland

- OELVs;132 BOELVs;133 BBLVs134 - Originally based on the US ACGIH list and the UK EH40. Today additional OEL lists form other European Countries + EU. = 800 OELVs 1 BOELV; 1 BBLV

Skin notations and notations for

Provisions on how to

carcinogens, reproductive hazards, mutagens and sensitising agents

calculate the OELs for mixtures

Same as in the ACGIH and the EU lists

No further information

- Bi-annually (2003) Italy

- EU IOELVs; EU BOELVs — Reference in collective agreements to the US ACGIH TLV list; EU Limit Value Lists - Corresponds to the number established at EU/ level - No further information

Occupational Exposure Limit Values. Biological Limit Values. Occupational Exposure Limit Values. Binding Occcupational Exposure Limit Values. Binding Biological Limit Values.

80 Beyond Limits

Country

00

o

Country

Type, origin, number and frequency of updating

notations etc

other information

see German & EU system

ditto

Same as in the ACGIH list

As in the ACGIH list

Skin notations and notations for carcinogens, reproductive hazards, mutagens, and sensitising agents

Provisions on how to calculate the OELs for mixtures. R Phrases according to Directive 67/548/EEC

OELs Luxembourg

- EUIQELVsjEUBQELVs - German MAK and TRK lists; EU LV lists. Corresponds to the number established at EU/level. - No further information

Portugal

- TLVs - Based on the US ACGIH list. — » 630 entries. — Yes (yearly) - Own system in place. ~ 620 main VLA entries (either VLA-EDs or VLA-ECs) of which » 50 are group entries, covering more than one substance - ~ 290 entries or group entries for carcinogenic and mutagenic substances. 35 VLB entries - Yes (2004)

Sweden

- LLVs;

138

CLVs;

STVs

140

Valor Limite Ambiental Exposition Diaria.

136

Valor Limite Ambiental Exposicidn de Corta Duracion. Valor Limite Bioldgico.

138

Level Limit Values.

o

§a

I

Skin notations and notations for

81

Ceiling Limit Values.

O

<5

139

135

137

Occupational Exposure Limits in the EU

- VLA-ED; Hi VLA-EC; I36 VLB; 137

Spain

Type, origin, number and frequency of updating

notations etc

OELs - Based on the US ACGIH list now own system in

carcinogens, reproductive hazards, and

place. - = 350 main entries including group entries

other information

<5

sensitising agents

- Yes but not clear what the time schedule is The Netherlands

- MACs;141 OELs - Own system in place

Skin notations, risk-based limit values for carcinogens

— ~ 770 main entries - Regularly United Kingdom142

- WELs143 - Own system in place - Around 100 previous OES deleted. Leaving nearly 400 substances with WELs. — Regular updates

Detailed in Environmental Hygiene Guidance Note EH 40, April 2005

Adequate control of exposure requires employers to apply principles of good practice, ensure the WEL is not exceeded and exposure to substances causing asthma, cancer

Short Term Values. Maximaal Aanvaarde Concentraties - Maximum Allowable Concentration. The UK system was subject to a major review at the time of writing of this book. It resulted in a new framework for OELs that came into effect with revised regulations in 2005. The entries in this table are based on the new system. However details of the previous system and its antecedents may be found in Chapter 4. Workplace Exposure Limit.

82 Beyond Limits

Country

Country

Type, origin, number and frequency of updating OELs

notations etc

other information or damage to genes is reduced as low as is reasonably practicable.

Occupational Exposure Limits in the EU

I I

s

83

Beyond Limits Limits 84 Beyond

PROCEDURES FOR SETTING OELS Table 3.3 provides an overview of the various procedures in place to establish OELs in the EU 15 countries. One interesting point of comparison is the extent to which social partners and other stakeholders are involved when setting national OELs. A more detailed description of the composition and the tasks of the various committees / institutes etc. involved in the development of OELs is provided in Annex IV. Table 3.3 Summary of procedures for setting OELs in EU 15 countries Country 144

Austria

Procedure Limit values are developed and adopted in a three-step procedure involving a scientific expert group, the Central Labour Inspectorate and the Advisory Committee for Workers Protection (Arbeitnehmerschutzbeirat). The scientific expert group evaluates available data in the scientific literature. The Committee takes case-by-case decisions: for example when it has more up-to-date data available than those on which the German MAK values are based or if for example the Nordic countries publish criteria documents justifying lower limit values. This is the place where socio-economic aspects are taken into consideration including technical feasibility and the possible economic consequences for industry. Based on its evaluation, the Committee develops a list of criteria documents (Begriindungen), which the Central Labour Inspectorate (ZentralArbeitsinspektorai) presents to the Advisory Committee for Workers Protection. The list is normally not further discussed in the Committee because the interest groups are also represented in its expert group on OELs. The changes of the OEL values or changes in the content (e.g. in criteria, definition, the text etc.) then undergo a type of legal 'screening' by Section i n in order to make them compatible with other laws and legislation. After having been sent out for the final comments of Social Partners, other interest groups and all other Ministries, the Minister of Economy and Labour

Die Arbeitsinspektion im Blickpunkt— Organisation, Rechte und Pftichien. Http://www.bmwa.gv.at/NR/idonlyres/0FEAA6D4-30FE-4713-8F2160B171119D3C/0/arbig_br.pdf.

Systems for for setting OELs in EU countries 85

publishes them in the Official Gazette, Proposals for changes/amendments/new OELs are submitted by either the Ministiy (Section III) or by social partners and less often by members of the scientific expert group itself. The agenda is prepared by the Central Labour Inspectorate or Zentrales Arbeitsinspektorat (as part of the Ministry and Section IX) which also chairs the meetings. Belgium

Members of the Federal Labour administration prepare modifications to adapt the Belgian list, mostly following changes in the EU. There is no official commission and no direct input either from scientific experts or the social partners.145 Nevertheless there are certain consultative bodies in which employers and workers are amongst those represented.

Denmark146

As a general rule, limit values are set and revised on the basis of scientific evidence (relating both to health aspects and control methods) from the EU (SCOEL), the US (ACGIH, NIOSH, OSHA), Germany (MAK), the Netherlands (DECOS), the Nordic countries, the Nordic Expert Group (NEG) and findings at Danish workplaces, compiled and analysed by the Danish Working Environment Authority. Limit values are set after notice has been given and any objections have been considered. The list of proposed new or revised limits is prepared by the Danish Working Environment Authority. The evidence relating to health aspects is assessed by a scientific quality committee. However, this stage is omitted in the case of proposals based on limit values adopted in the US or Germany or recommendations from the EU. The Danish Working Environment Council's Committee on Limit Values, which consists of representatives of employers* and employees* organisations, then performs a technical/economic evaluation of the limit value levels. Based on this, the Danish Working Environment Council submits a recommendation to the Director General of the Danish Working Environment Authority, who in turn lays down the limit values and publishes them in a list of limit values (Appendix to the Guide to work Environment Act). In the event of disagreement in the Danish Working Environment Council, the Director General lays down the limit value based on the following guidelines: -

In principle, a limit value should not be stricter than in those countries with which Denmark can normally be compared - primarily the

Information given by the Belgian member of SCOEL. Http://www.arbejdstilsYnet.dk/graphics/at/engelsk-pdf/at-vejledninger/gvlisteuk.pdf.

86 Beyond Limits

Nordic countries, but also Germany and the US. -

Information that affected enterprises will incur considerable extra costs as a consequence of the change should be considered together with any uncertainties concerning the medical documentation.

In special cases the Director General of the Danish Working Environment Authority may set limit values without following the general procedure. This applies where there is information concerning a particular risk in using the substances. Finland"7

The Advisory Committee for Occupational Health and Safety on Chemicals together with the Ministry's Occupational Safety and Health Department prepares the list of harmful concentrations. The Committee selects a Sub-Committee of Exposure Limits (HTP- jaos), which does the actual preparation work for setting OELs. Sub-Committee members are from the Ministry, chemical industry, employers' organisations and the trade union movement. The Sub-Committee prepares drafts for recommendations. The process is started by the preparation of a short documentation on the use and chemical-physical properties of the agents and the observed health effects with a specific emphasis on the dose-response relationships. The critical effect is selected and the exposure limit recommended. The documentation is not publicly available, it is delivered only to the Advisory Committee together with the proposed list When drafting MAC values not only adverse health effects but also socioeconomic and technical feasibility factors are taken into consideration. The discussion on HTP values is restricted to adverse health effects and measurement techniques for the substance. During the preparation of the recommendations, standards of other countries including OELs set at European level148 and the reasoning given for these standards are taken into consideration. The Ministry of Social Affairs and Health decides on Occupational Exposure Limits according to the proposal of the Advisory Committee for Occupational Health and Safety of Chemicals.

Information is taken from the website of the Ministry Http://www.vn.fi/stm/english/mdex.htm. SCOEL, Nordic Expert Group, ACGIH, MAK-Komission, DECOS, IPCS Health Criteria, HSE and Swedish limit value documents.

Systems for for setting OELs in EU countries 87

France

Recommendations for Limit Values {Valeurs limites) and their revisions are developed and up-dated by an scientific expert group under the direction of the Ministry in Charge of Work {Groups, scientifique pour la surveillance des atmospheres de travail - Scientific Group for the Surveillance of the Working Atmosphere/Environment) The OELs are based on a review of the international scientific literature and studies (toxicological and epidemiological data) undertaken by the regional authorities. Then the technical and economical feasibility of the proposed health-based OEL is studied mostly by the industry participating in the limit setting and reviewing. The same scientific expert group also elaborates the document dealing with the scientific basis and the principles for the application of Biological Exposure Indicators {Indicateurs biologiques d'exposition - IBE). Some values are also recommended by the National Health Insurance Fund for Salaried Employees (CNAMTS). After having being published by the Ministry, the National Institute of Research and Safety (Institut National de Recherche et de Securite - INSR), publishes regularly consolidated lists of admissible limit values including their definitions and other additional information on standards for measurement techniques, procedures for mixtures etc.

Germany

The following summarises the situation before the new Ordinance on Hazardous Substances came into force (1 January 2005). It is not clear how the system will look in the future but it is assumed that it will in principle meet similar criteria. The Technical Rules for Hazardous Substances are developed and adapted by the Committee on Hazardous Substances {Awsckufifiir Gefahrstoffe - AGS). Within the relevant sub-cormnittee(s), the MAK and BAT recommendations of the MAK Commission are discussed, as well as OELs established by other bodies (e.g. the EU). Based on these discussions, the sub-committee(s) propose(s) MAK and BAT values to the plenary meeting for final approval. TRK values are developed within a specific sub-committee and also forwarded to the plenary meeting for final approval. Both types of recommendations are finally discussed, and may be again changed and approved by the plenary meeting of the Committee for Hazardous Substances. After having been adopted by the plenary meeting of the Committee on Hazardous Substances, the Federal Ministry of Economics and Labour announces the Technical Rules in the Federal Labour Gazette (Bundesarbeitsblatt - BArbBl.).

88 Beyond Limits

See Chapter 5 for further detail.

Greece

The OELs are the products of a compromise reached after considering health, administrative, political and economic issues. There is a two tier system in place to set OELs, comprising a scientific advisory committee and a second level in the form of the National Council for Health and Safety at Work (SYAE) in which stakeholder interests are able to take account of these issues. Negotiations take place within SYAE. SYAE deliberates on all matters pertaining to occupational health and safety and is effectively an institutionalised forum for national consultation: 17 bodies are represented on the Council, The General Directorate of Working Conditions of the Ministry of Employment and Social Protection through its Directorate of Working Conditions has the task of sending the summary information report of the emerging decision as a Presidential Decree (P.D.) and attaching to it a copy of the state journal containing the relevant list of OELs. Copies of the official journal are sent to the social, administrative, economic and scientific bodies participating in and represented in SYAE. See Chapter 6 for further details.

Ireland

The Health and Safety Authority (HSA) is responsible for producing, disseminating and enforcing Occupational Exposure Limits in the Republic of Ireland. The national list, when introduced in 1994, was based on the occupational exposure standards for some 700 chemicals applicable in the United Kingdom (EH 40), with the inclusion of additional chemicals contained in the US (ACGIH) list but not in the UK list. The procedures used in the revision of the list are similar to those used in the establishment of the first list in 1994. The scientific staff of the HSA prepare the initial draft list, it is then placed before the Authority's Dangerous Substances Advisory Committee (DSAC). Following discussion by an expert subgroup of the DSAC and consequent approval by the full DSAC the list is submitted to the Legislation and Guidance subcommittee of the Board of the Authority and thence to the tripartite Board for further consultation. Following this, the Board recommends the revised Code of Practice to the Minister for Enterprise and Employment for written consent, in accordance with section 30 (4) of the Safety, Health and Welfare at Work Act, 1989 Periodic revisions are done on a biennial basis. The approach to revision of the Code of Practice has been to consider recent changes in OELs in both the

Systems for for setting OELs in EU countries 89

US and the UK and also in other European countries, with a view to amending the national list in parallel. Revision also takes account of those OELs that have been harmonised at European Community level via a European Directive (see above) Italy

In Italy, no national system exists for establishing OELs. Legislation limiting exposure to hazardous chemicals generally comes in the form of decrees by the Italian Government or the Ministries of Health and Labour.14* In addition, TLVs of the ACGIH have sometimes been included in sectoral collective agreements between trade unions and employers' organisations.150 In Italian law such agreements have a legal status. Until recently there was no national committee/advisory board or other regulatory body dealing exclusively with the establishment of OELs. The only (historical) example of such a body existed in 1975, when the former ENPI (Ente Nazionale Prevenzione Infortuni - National Agency for Prevention of Accidents at Work) issued a provisional list of recommended OELs, which was never approved at national level. Although historically there was no specialised body at national level dealing exclusively with OELs, a number of committees and bodies existed that dealt with H&S issues in general or including OELs. Some of them are multi-partite bodies. The most important ones are: -

The National Institute of Occupational Safety and Health {Istituto Superioreper la Prevenzione e la Sicurezza del Lavoro - ISPESL)

-

The National Institute of Health (Istituto Superiore di Sanita - ISS)

-

The National Advisory Committee on Toxicology (Commissione consultiva tossicologica nazionale)

-

The National Institute of Insurance against Accidents at Work (Instituto Nazionale per L'Assicurazione contra gli Infortuni sul Lavoro -ENTAIL)

-

The Italian Institute of Social Medicine (Istituto Italiano di Medicina Sociale -HMS)

-

The Permanent Advisory Committee for Accidents Prevention and Occupational Hygiene {Commissione consultiva permanente per la prevenzione degli infortuni e Vigiene del lavoro).

Implementing the EU Chemical Agents Directive and the 1OELVDirective —

Information given by the ISPES. Information given by members of the trade unions, in Italy and the TUTB and an epidemiologist from the University of Turin.

90 Beyond Limits

In order to implement the transposition of the EU Chemical Agents Directive and the IOELV Directive made under it, several new committees and working groups have been set up. One is composed of nominees of the various ministries and is responsible for implementation of indicative values in the IOELV Directive. The Ministries of Labour and of Industry have defined the need for a Working Group, with membership of about 25 persons representing wide ranging interests, in order to assist with guidance on the definition of risk. It is particularly charged with dealing with the needs of small enterprises. At the same time there is a committee with regional representation that is working on the same issue. See Chapter 7 for further details. Luxembourg

No specific committee (scientific or other) exists to discuss limit values at the national level but Social Partners and other interest groups are consulted during the general procedure of proposing and adopting legislation in Luxembourg,

Portugal

There is no special body officially involved in the development of OELs at national level. Consultation of Social Partners and other interest groups takes place in Portugal via the Economic and Social Council {Conselho Economico e Social - CES). Within the CES, the Permanent Commission of Social Consultation (Comissao Permananete de Cancertacao Social) deals with topics related to H&S. A consultation procedure for legislation in the pipeline takes place regularly via a bulletin of the Ministry,151 which is published four times a month and which gives all interest groups the possibility to respond with comments.

Spain152

Since 1998, limit values have been developed and published by the National Institute of Safety and Hygiene at Work (Institute) National de Seguridad e Higiene en el Trabqjo — INSHT) as reference values. They are approved by the National Commission of Security and Health at Work (Comision National de Seguridady Salud en el Trabajo).

)53154

Sweden135

Since 1978 the procedure of setting standards (OELs) in Sweden has been

Boletim do Trabaiko e Emprego BTE; http://www.dgeUnts.go¥.pt/avisos_lsem_02.hta. http://www.prevenciona.cara/descargas/toxicos/limites_exposicion.doc. http://www.cgtesAegislacion/textos/Limites-Exposicioii-Profesional-Agentes-Quimicos.pdf. http://www.mtas.es/mshtf en/index_en.htm.

Systems for for setting OELs in EU countries 91

structured in a multi-step manner. There is a separation of the scientific (risk identification and risk estimation) from the political issues (risk evaluation and risk aceeptance).Two working groups are involved in the process, the Criteria Group and the Regulation Group. The task of the Criteria Group is to collect and evaluate the available information on substances that the Regulation Group selects for their consideration. The findings of the Criteria Group are summarised in a consensus report published in both Swedish and English. The Criteria Group bases its conclusions on the evidence available in the scientific literature and has no resources for commissioning new epidemiological or experimental studies. The Criteria Group does not propose an OEL or a numerical limit value. Instead these are proposed by the Regulation Group, within the National Board of Occupational Safety and Health and with representatives from the NBOSH and from the employees' and employers' confederation. The Regulation Group makes use of the consensus report and performs a costbenefit analysis, furthermore, technical feasibility criteria are taken into consideration and an analysis of consequences is discussed. Final decisions are made by the Board of Directors of the NBOSH.

The Netherlands1*

See Chapter 9 for further details. There are two main procedures for establishing an OEL in the Netherlands. 1. Procedure for establishing a statutory OEL The procedure has three stages: A group of independent experts (currently the Dutch Health Council Expert Committee on Occupational Standards, or Commissie WGD) makes a recommendation for an OEL for a given substance, based on toxicological considerations. A tripartite committee (the OEL Subcommittee) then considers this recommendation in the light of its socioeconomic and technical consequences and the practical feasibility of introducing it as an OEL, and makes a recommendation to the Minister of Social Affairs and Employment. The Minister may then decide to set the

The role of human neurobehavioural tests in regulatory activity on chemicals. - A Swedish view on the interpretation of tests and their application to the regulation of chemicals; Christer Edling MD,PhD Department of Occupational and Environmental Medicine, University Hospital, S-851 85 Uppsala, Sweden, Per Lundberg, PhD Department of Toxicology, National Institute for Working Life, S-171 84 Solna, Sweden. http://www.ser jil/default.asp?desc=en_oel_toel_proc.

92 Beyond Limits

proposed limit as the statutory OEL on the basis of both recommendations. Since 2002, OELs established by the SCOEL have been incorporated into the Dutch procedure for setting statutory OELs. 2. Procedure for establishing an administrative OEL The procedure for establishing an administrative OEL has two stages: The OEL Subcommittee selects for assessment an OEL currently in use in a foreign country. After satisfying itself that the OEL is appropriate and can be feasibly implemented in the Netherlands, the OEL Subcommittee may then recommend to the Minister that it be adopted as an OEL in the Netherlands. On the basis of the OEL Subcommittee's recommendation, the Minister may then decide to approve this foreign OEL as an administrative OEL for the substance. The Dutch Health Council Expert Committee on Occupational Standards is not involved in setting an administrative OEL. In choosing foreign OELs for assessment, the OEL Subcommittee draws primarily on the OEL lists of Germany, Sweden and the UK, as the procedures for setting OELs in these countries are very similar to the procedure used in the Netherlands. In assessing a proposed (statutory or administrative) OEL, the Subcommittee first assigns the proposed OEL to a particular Working Programme, according to its country of origin. The OEL Subcommittee then seeks the involvement of relevant groups (e.g., employers' and employees' organisations, trade associations, Occupational Health & Safety Services and other organisations). Trade associations and Occupational Health & Safety Services are specifically invited to register an interest in contributing to a feasibility study concerning the implementation of proposed (statutory or administrative) OELs, in order to ensure that, before it is adopted, any proposed OEL can realistically be implemented in practice. The Subcommittee then invites industrial sector organisations to submit information on the feasibility of implementing the proposed (statutory or administrative) OEL. If the Subcommittee receives no information or reports, it assumes that the proposed OEL is acceptable and its implementation will be possible. The Subcommittee then recommends to the Minister that the proposed (statutory or administrative) OEL should be adopted. See Chapter 8 for further details

Systems for for setting OELs in EU countries 93

United Kingdom

The UK. introduced a new framework for OELs in 2005. The two limit level system (occupational exposure standards - OES and maximum exposure limits - MEL) of the previous decade was replaced with a single limit (Workplace Exposure Limit -WEL) system in a revised legislative framework for chemical hazards. Under the old system, if the HSE believed a substance merited an OEL, and there was no relevant EU limit, it supplied information on a substance to the Working Group for the Assessment of Toxic Chemicals (WATCH), a sub-committee of the HSC's tripartite Advisory Committee on Toxic Substances (ACTS): -

-

if WATCH considered the substance satisfied the OES criteria, it recommended an OES (8-hour TWA or 15-minute short-term limit), to ACTS if ACTS agreed to the recommendation, the proposals were published in a consultation document following consultation and HSC agreement, the OES was published in the annual guidance note on OELs (EH40).

If WATCH did not recommend an OES, it referred the substance back to ACTS, normally for setting a MEL (because it involved socio-economic judgements, balancing risk to health against the cost and effort of reducing exposure). If ACTS agreed, the HSE issued a Chemical Hazard Alert Notice (CHAN) as an interim measure to inform industry of the serious health risks associated with the use of the substance. If a MEL was to be set, the HSE collected information on good occupational hygiene practice for the use of the substance and made proposals to ACTS for the MEL, accompanied by a regulatory impact assessment. The process was then the same for an OES. Where ACTS rejected an MEL, employers were still expected to establish appropriate control regimes based on the CHAN. Where an EU OEL had to be transposed, the Working Group on European Exposure Limits (WEELS) would take account of the scientific evaluation of the SCOEL. WEELS considered whether an OES or a MEL was appropriate, whether any existing limit complied with the EU limit and whether there were reasons to recommend a substantially different limit. If a new or revised OEL was required, WEELS made recommendations to ACTS. WEELS could also recommend to ACTS the referral of a substance to WATCH for a scientific opinion. The new system has transferred all previous MELs and all but 102 of existing

94 Beyond Beyond Limits Limits 94

OES to WELs. Procedures for setting new WELs are likely to be essentially the same as those involved in setting previous MELs. See Chapter 4 for further details.

ENFORCEMENT & SURVEILLANCE OF COMPLIANCE WITH OELS IN EU15 COUNTRIES All countries in Europe have the legal basis for enforcement and surveillance procedures. In each case regulatory authorities for health and safety are (at least theoretically) engaged with securing compliance with the standards set by OELs and in monitoring their role in risk assessment anrol of chemical hazards. Breach of requirements relating to binding values is either a criminal or administrative offence (or both) depending on the national regulatory system and the seriousness of the breach. Penalties are most commonly fines, the levels of which are defined usually in the relevant legislation.

AUSTRIA Enforcement Authority:

Central Labour Inspectorate (Zentral Arbeitsinspektorat) and its departments

Enforcement powers. The legal basis of the Labour inspectorate's powers is found in the Law on Labour Inspection of 1993 (Arbeitsinspektionsgesetz) - ArbIG, BGB1 Nr. 27 / 1993. There are 19 regional Labour Inspectorates and 1 Labour Inspectorate for building works directly subordinated to the Central Labour Inspectorate. It employs about 550 persons in total of which about 300 are workplace labour inspectors. They look after about 210,000 work places and monitor compliance with safety regulations for about 2.4 million employees. Most of the Labour Inspectorates have a technical department and a safety department to protect various groups (pregnant women, young people etc.). Each Labour Inspectorate has a special medical service. The Central Labour Inspectorate does not perform measurements on its own, but depending on results of the visits of the local labour inspectors, it asks the Central

Systems for for setting OELs in EU countries 95 Office for Accidents and Occupational Diseases157 (of the Federal Accident Insurance Institution) to perform measurements.158 The results of these measurements are kept at the local offices of the Labour Inspectorate but are not publicly available because they are the result of an official legal procedure. In some cases (e.g. for wood dust, solvents or isdcyanates), the Central Office performs - within the framework of research projects - systematic measurements in order to get an overview of a specific type of exposure. The results of these research projects are published as technical reports and are publicly available. Most of the Labour Inspectorates have a technical department and a safety department to protect various groups (pregnant women, young people etc.).

BELGIUM 159 Enforcement Authority:

The Labour Inspectorate Q'lnspection du Travail) is responsible for monitoring and enforcing the H&S legislation including that on OELs

Enforcement powers. Under Lot du 16 novembre 1972 concernant Vinspection du travail au plan national et la Convention O.I.T. n° 81 au niveau international. The technical inspection section of the Labour Inspectorate is responsible for safety surveillance whilst the medical section monitors health. Visits should be performed (in general) once a year in each enterprise although special visils are made if there is a request, a complaint or a particular incident which causes concern. The ordinary visit consists of a general check of the application of the laws and regulations in the company. The shortcomings are registered and kept in a record. The purpose of these general visits is to check the general performance of a company with respect to occupational health and safety obligations. The procedure and the measures taken during a special visit depend mainly on the reason for this special visit. If the special visit takes place because of a complaint, it is important to notice the person behind the complaint remains anonymous. Special visits are not announced and the inspector can take all the measures within his/her competence he/she thinks are necessary (including measurements etc.).

Bmqnstelleftir Unfall- und Berufskrankheitenbek&npfiing - HUB. AllgEtneine UnfallversicherungsanstaU. Http://www.meta,fgov.be/pa/paa/ftamesetftiOO.htm.

96 96 Beyond Beyond Limits Limits Based on the results of the visit, all possible measures (from simple information up to the issue of penalties) can be performed.

DENMARK 160 Enforcement Authority:

The Danish Working Environment Authority (WEA) supervises whether Acts and rules in the field of safety and health at work are observed, inter alia through inspection visits and guidance of the enterprises and their safety organisations.

Enforcement powers. The Working Environment Authority applies, in particular, six methods of inspection: — Screening, which is a quick review of the working environment at the enterprise with a view to assessing whether it should be subjected to adapted inspection. - Adapted inspection, in which the Danish Working Environment Authority targets its resources on the enterprises which have the most hazardous working environment conditions. - Detailed inspection takes the form of inspection of problems or problem areas, including examination of work-related accidents, diseases and ailments. — Supplier inspection takes the form of inspection of safety and health for the users of one or more of the suppliers' products. — Project and counselling inspection, includes inspection of the rights and duties of the project and counselling parties in compliance with the Danish Working Environment Act. - Special inspection includes inspection of lifts, boilers, containers, pipeline systems, natural gas plants, risk enterprises and genetics laboratories. Manufacturing controls are performed in the case of boilers for the purpose of export and import. The WEA has the power to issue administrative fines in the case of clear violations of the substantive rules of the Working Environment Act. In cases of extreme danger, the WEA may also order the work to be suspended.

http://www.at.dk/swl2159.a8p.

Systems for for setting OELs in EU countries 97 The different forms of sanctions, i.e. improvement notices, legal charges, administrative fines and guidelines - will depend on both the enterprise's actual working environment standards and on its own efforts. Complaints against decisions made in compliance with the working environment Act by the WEA may be brought before a working environment appeal board. These boards include representatives of the social partners. The inspection of enterprises is integrated into four regional Inspection Centres, each with approximately 100 employees. The inspectors of the local units of the Work Environment Service are responsible for carrying out inspection.

FINLAND"' Enforcement Authority

The Occupational Safety and Health Inspectorates of Finland, supervised by the Ministry of Social Affairs and Health, are the enforcing authorities for occupational safety and health.

Enforcement powers. The powers given to the OHS inspectors and OHS Districts are defined in the Labour Inspection Act (1973) - Laki tydsuojelun valvotmasta ja muutoksenhausta tyosuojeluasiaoksa, Act of 16.2.1973/171. The Inspectorates give instructions and advice on applying regulations concerning working conditions, employment and equality and supervise that they are observed in workplaces. The Occupational Safety and Health Inspectorates also give employees advice on matters concerning occupational safety and health and employment. The occupational safety and health inspector has the right to visit all workplaces and other places under supervision and to look at the necessary documents as regards occupational safety and health enforcement. The Occupational Safety and Health Inspectorates can, if necessary, oblige the employer to redress defects in occupational safety and health in the workplace. The inspector is obligated to secrecy concerning business secrets and employees' health and the possible inspection requests made from the workplace.

http://www.dOHSnet.fi/hallinto/english/piirit/default.htm.

98 Beyond Limits The district authorities for occupational safety and health carry out the practical supervision and other activities in the field of OHS. The country is divided into eleven OHS districts. Each District has one central office and several local offices. The Occupational Safety and Health Inspectorates employ approximately 460 people; about 360 of these do field surveys at workplaces. There are experts in different professional areas (engineering, chemistry, law, construction engineering, nursing). Normally the OHS Districts are organised into group structures. Each group has responsibility for one or more sectors of industry and services. Inspectors are specialised in those industries they have been assigned. The most important target of OHS inspection visits in the past was to observe any defects in working conditions, to eliminate hazards in the working environment and, by that means, to reduce accidents and work-related diseases. Nowadays the inspection methods are more sophisticated. The central task of the OHS District is to monitor that the provisions of OHS legislation are observed, and to support and encourage the development of OHS management systems at working places. Guidance is given to both employers and employees. OHS inspectors and OHS Districts have the power to: -

-

-

issue an inspection protocol or improvement notice. The notice identifies the law that is broken, describes the nature of the deficiency, may suggest how the deficiency can be rectified (although this is not necessary), and stipulates the time limit by which the employer must respond to the OHS District indicating the action he or she has taken issue a legally binding enforcement notice under the authority of the Head of the District if the inspection protocol has not had the desired effect. The notice stipulates a time limit by which the required work must be completed and may, although this is not obligatory, set a fine, which must be paid if the deadline is not met. The employer has the right of appeal to the regional Administrative Court. issue a prohibition notice in cases where an inspector believes there is an imminent risk to life or health (about 30-40 per year). The notice comes into force immediately. The initiating inspector submits a copy of the notice to the Head of the District, who decides whether to support the notice or rescind it. The employer again has the right to appeal to the Administrative Court. Should the employer not comply with the notice, the matter is put in the hands of the police, who have the powers necessary to ensure that compliance is achieved. This procedure is used rarely.

Systems for for setting OELs in EU countries 99

In cases of wilful intent or negligence, and normally following an accident, the inspector may draw up a report for the public prosecutor who will initiate an investigation by the police (about 300 are initiated per year). Any prosecution which follows may lead to the offender being fined or sent to prison. The prosecution will be taken against an individual or individuals within the enterprise since there is no possibility in the law for proceedings to be taken against the company itself. According to the senior civil servant of the Ministry of Social Affairs and Health interviewed, "The district offices of the labour protection inspection are responsible for the enforcing the limit values. The inspectors seldom study the compliance with the OELs as a separate issue from other issues. I do not remember a case here [in which] the sole excess of an OEL would have been the[exclusive] reason for enforcement measures by the authority. The air concentration values in excess of the OELs are usually used as evidence of failure of the safety programme of the employer".

FRANCE 1 6 2

m

Enforcement Authorities

The Labour Inspectorate (/ 'Inspection du Travail) of the Ministry of Labour is responsible for the surveillance and enforcement of the legislation. In addition, the organisations for social security exert, within the framework of their function as insurance companies, a system of specific control and incentives to ensure the application of the legislation at enterprise level.

Enforcement powers. Measures on hygiene, safety and working conditions and on the functioning of workers' representation on health and safety are part of the Labour Code which is the main instrument on which the Labour Inspectorate relies to perform its tasks. With two complementary external intervention systems at enterprise level with respect to surveillance and enforcement of legislation in the field of health and safety and the prevention of occupational risks, the French system is a dual one. There is, on the one hand, the Labour Inspectorate as part of the Ministry of Labour, and on the other

http://www.sante-securite.fravail.gouv.fr/pdf/InspectioiiTravailFrance2002.pdf. http://www.8ante-aecurite.travail.gouv.fr/systeme/institations.html, http://fr.OHSa.eu.int/publications/acteurs.stm. http://www.inrs.fr/actualites/chsctl .htm.

100 Beyond Limits 100 hand are the institutions of the social security system (regional and national) and their surveillance systems. Both the Labour Inspectorate and the surveillance and enforcement bodies of the social security organisations not only control the application of the labour law but also advise the companies in areas related to H&S. Labour inspectors have the right to enter enterprises at any time. They must be given access to documents they need and can perform measurements and take samples. If they register infringements of regulations, they may: -

remind the employer of his obligations issue improvement or enforcement notices impose fines in urgent cases, apply for a provisional legal order at court to stop the work.

The difference between the two types of French limit values, their enforcement, and the possibilities labour inspectors have becomes clear when looking at the power of the Labour Inspectorate with respect to these two OELs.164 Air quality control measurements by the labour inspectors are only possible for substances for which a binding limit value exists, which are those for dust/fibres of asbestos, lead, benzene, vinyl chloride monomers etc. For substances for which indicative limit values have been adopted and published, the order of 9 October 1987 does not allow the labour inspectors to enforce these OELs directly by issuing improvement or enforcement orders. The nature of these limit values ('indicative/guidance') does not permit prescription of exact measures to 'enforce' them. The only possibility to 'enforce' them is via indirect sanctions on failures of the ventilation system and similar offences. The Labour Inspectorate monitoring function has been extended to include compliance with provisions deriving from collective agreements. In addition to this, it also performs advisory and information functions, has responsibilities in the settlement of disputes and possesses certain decision-making powers. It may take part in the meetings of the CHSCT.16S At enterprise and establishment level, the labour inspector is the official who has direct dealings with enterprise managers, unions and workforce representatives and

http://www.inrs.fr/dossiers/ed773.pdf. Le Comiti d'hygiine, de sicurtte et des conditions de travail - the OHS advisory committee of management and workers at enterprise level.

Systems for for setting OELs in EU countries 101 employees. They are supported by other experts like the occupational physician and the safety engineers) who are part of the OHS system the employer has to establish. The National Health Insurance (Caisse National d'Assurance Maladie - CNAM).1* lm 168 Since 1945, CNAM, under the supervision of the Ministry of Health, has been responsible for the compensation of industrial accidents and the administration of occupational risks and occupational diseases. Its mission is also to prevent occupational accidents and occupational diseases by technical and financial means. CNAM administers the national fund for prevention which is based on contributions levied from enterprises. The prevention service and its regional offices and services is financed from this fund, as well as the work of the INRS, the National Institute of Research and Safety. At regional level,169 its inspectors and consulting engineers have the same access and inquiry right as the national labour inspectors have. They perform risk assessments and give advice on prevention and protection measures in consultation and co-operation with the Committee for Hygiene, Security and Working Conditions - CHSCT. They can also refer to specialised laboratories.' If an employer fails to follow the advice given, the inspectors have the right to take all the necessary measures they consider justifiable under the circumstances and, if necessary, they can issue improvement or enforcement notices. CRAM is able to impose higher contributions on whole sectors or individual enterprises based on health and safety performance outcomes such as raised injury rates. Reductions in contributions reflecting improved health and safety performance are also possible. CRAM organises information and training courses for employers and employees, campaigns to tackle specific problems and publishes journals and brochures. The data about occupational injuries, accidents and diseases as well as all other data gathered and collected during the visits are taken into consideration when designing policy priorities in the field of occupational health and safety at ministerial level.

http://www.crain-bfc.fr/preventioii/page-preventioii.htni. http://machines-dangereuses.drt.travail.gouv.fr/ct5/rainitra.htm. http://www.sante-securite.travail.gouv.fr/systeme/ministere.html. CRAM'— Caisse regional d'assurance maladie.

102 Beyond Limits 102 GERMANY Enforcement Authorities

Trade Supervisory Offices (Gewerbeaufsichtsamter) or the Regional Offices for Industrial Safety (Landesdmter fiir Arbeitsschutz) of the Lander Technical Inspection Service (Technischer Aufsichtsdienst) of the Berufsgenossenschaften

Enforcement powers. The legal basis for inspection is found in the Industrial Code (Gewerbeordnung (GewO)) in der Fassung der Bekanntmachung vom 22. Februar 1999 (BGBl. I S. 202). The inspectors have the same powers as the local police for the execution of their duties. In cases of lack or violation of laws and regulations, inspectors can issue orders and make use of the compulsory measures/sanctions they are entitled to use according to the relevant State laws. Normally this covers the remedy of the situation at the expense of the employer or the establishment and/or the setting of fines. Additionally, they can order the suspension/cessation of parts or the whole of the production process or initiate ongoing penalties.

Powers of the Technical Inspection Service. The institutions for statutory accident insurance and prevention and their Technical Inspection Service are also responsible for the surveillance of the Hazardous Substances Regulation and its Technical Rules. Both surveillance authorities also offer special support for small and medium sized enterprises with respect to training and measurement techniques. See Chapter 5 for further details.

Systems for for setting OELs in EU countries 103 GREECE Enforcement Authority

Greek Labour Inspectorate (SEPE). Legal basis. Presidential Decree 136/99

Enforcement powers. The SEPE is organised on the basis of a central service and regional services SEPE Occupational Risk Prevention Centres and local departments when in need of extra expert assistance in enforcing the OELs have access to the scientific and technical support of the Centre of Health and Safety at Work (KYAE). The basic objective of the Labour Inspectorate is to monitor the implementation of the provisions of labour legislation in respect of terms and conditions of employment (such as working time limits and pay); the legality of employment; the investigation of workers' social insurance coverage as well as workers' health and safety conditions. The labour inspector may impose sanctions on any employer, manufacturer, producer, importer or supplier who infringes the provisions of the health and safety laws or the provisions of the presidential decrees or ministerial decisions issued under the terms of these laws, which ranges from: -

advice improvement notices administrative sanctions penal sanctions

The Minister of Labour may impose the following sanctions, after receiving a reasoned report from the labour inspector: -

temporary cessation of the operations of the particular production process or section or of the entire undertaking for a period of more than three days. complete cessation of the operations of the particular production process or section or the entire undertaking

Imprisonment or a fine of at least €300 shall punish any employer, manufacturer, producer, importer or supplier who wilfully violates the Act or the rules promulgated by

104 Beyond Limits 104 it. Offences committed due to negligence (on conviction) carry the full sanction of a fine or a prison sentence not exceeding one year. See Chapter 6 for further details.

IRELAND Enforcement Authority

The HSA is responsible for producing, disseminating and enforcing Occupational Exposure Limits in the Republic of Ireland. The Chemical Agents Regulations and the related OELs are enforced by the workplace inspectors employed by the HSA

Enforcement powers. Inspector may: -

-

-

In addition to rights of entry, inspection and sampling an

issue an Improvement Direction, to which an employer is required to respond with an Improvement Plan in relation to activities to which the inspector considers may involve risk to safety or health of persons issue an Improvement Notice stating his opinion that an employer has broken a provision of an Act or Regulation issue a Prohibition Notice in relation to an activity, which the inspector is of the opinion has been, or is likely to be, a risk of serious personal injury to persons at work. This might require an immediate stoppage of work in certain cases recommend the initiation of prosecutions give directions or instructions.

It should be noted that the above list is non-exhaustive and powers of inspectors are listed in no particular order. In certain circumstances, the Authority may apply under Section 39 of the 1989 Act to the High Court for an Order in relation to certain activities. This can be obtained on an ex parte basis, that is, without notice to the employer concerned. These orders are usually obtained where physical hazards and significant deficiencies in health and safety management cause the Authority to consider the risk to persons to be very serious.

Systems for for setting OELs in EU countries 105 ITALY Enforcement Authorities

Labour Inspectorate (Ispettorato del Lavoro) Local Health Agencies (L'unita sanitaria locale)

Enforcement powers. Between 1955 and 1978 the Labour Inspectorate {Ispettorato del Lavoro) as an office of the Ministry of Labour, decentralised to regional and provincial level, was the main body responsible for monitoring the application of labour legislation and collective agreements and the functioning of social insurance, welfare and health arrangements. In 1978, the Health Services Act (Law 833/78) instituted the National Health Service structured in Local Health Agencies (L'unita sanitaria locale - USL) at regional level under the Ministry of Health, In each USL, among the traditional health services (Aziende sanitarie locali - ASL) a unit for Occupational Health and Safety (Servizio di Prevenzione e Sicurezza negli Ambient! di Lavoro - PSAL) was established. The law gave some of the powers of the Labour Inspectorate to the PSAL. They were provided with regulatory powers on health and safety and enabled them to use these powers in addition to their preventive advisory activities. In the context of the implementation of the EU Framework Directive 89391/EEC a more significant inspection role for the Labour Inspectorate was introduced in the late 1990s. The decree DPCM 14.10.1997 n.4121™ identified higher risk sectors where control can be undertaken jointly by Labour Inspectorate and the prevention service of the USL. PSAL activities include: -

sectoral prevention plans controls on OHS legislation controls on medical surveillance carried out by the 'Competent Doctor' of the company examining plans for the removal of asbestos preventive assessment of new activities, plants and work-sites criminal investigations on work accidents and occupational diseases providing information to workers on control activities

Decreto del Presidente del Consiglio del Mlnistri, Reingresso delVispettorato del Lavoro nett'attivita di vigilanza; http://www.626.cisl.if/doconlJne/Legislazione/Leggi%20 Decreti/Dec%20pres%20consiglio%20ministri.htm.

106 Beyond Limits 106 — giving information and training on legislation and authority policies to workers, trade unionists, employers and experts. See Chapter 7 for further details.

LUXEMBOURG™ Enforcement Authority

With the reorganisation of the Labour and Mines Inspectorate in 1974, it (L'Inspection du Travail et des Mines - ITM) was given responsibility for ensuring the implementation of all legislation relating to the working conditions and protection of all employees subject to a contract of employment, except those in the public service.

Enforcement powers. ITM has responsibility for many other matters apart from health and safety. Its inspectors are empowered to: — issue an order requiring rectification of faults caused by a failure to comply with the requirements of the relevant legislation within a given time period — issue an order requiring immediate action when there is an imminent threat to the health and safety of an employee — issue an order requiring an installation to be inspected within a time limit set by the inspector by a specialist body approved by the Minister of Labour. The cost of inspection falls to the employer. The Inspectorate has close co-operation and collaboration with other organisations and government departments which also have an interest in the subject of health and safety at work. These are: — Association d'Assurance contre les Accidents (AAA)

http://www.itm.etat.lu/#sec_au_travail.

107 Systems for for setting OELs in EU countries 107 The Ministry of Health, particularly with a small group of doctors whose interest lies in occupational medicine and the problems of health and hygiene at work The Ministry of Public Affairs which has a small Inspectorate with the responsibility of overseeing the safety of employees in the public sector including those at work in the health service and education Approved technical organisations - organismes agrees - appointed by the Minister of Labour to carry out inspections and surveys in their designated areas of competence The Customs Service whose officers are increasingly being used to assist the Labour Inspectorate in its work The Consultative Committee for Labour Inspection.

PORTUGAL 172

m

Enforcement Authority

The Labour Inspectorate {Inspecgao Geral do Trabalho IGT) is responsible for the surveillance and enforcement of H&S regulations.

Enforcement powers. The IGT is a department directly under the Ministry of Employment but endowed with administrative autonomy, possessing powers to ensure compliance with legal provisions on working conditions and the system of employee protection at work and during unemployment. Its inspectors have the requisite powers and may call on the intervention of other authorities such as the police where necessary. Structurally, it comprises both central and peripheral offices, including regional services and co-ordinating centres. Its activities include education and guidance, enforcement and inspection. It may also dictate how contraventions should be rectified, as well as any changes necessary to ensure strict application of the legal provisions on health and safely at work and including immediate measures in cases where the life, health or safety of employees is in imminent danger.

172

™

http://www.idict.gov.pt/desteques/igt_dne/igthtm. Decreto-Lein."219/93, de 16 deJunho.

108 Beyond Limits 108 SPAIN Enforcement Authority

Monitoring and enforcement of the legislation is performed by the Labour Inspectorate

Enforcement powers. Labour Inspectors have rights of access to workplaces and to certain information kept by the enterprise and can issue official notifications (of infringement, settlement, etc.) and propose administrative or penal sanctions for violations of social legislation Administrative offences, which are subject to sanctions imposed at the proposal of the Labour Inspectorate, are covered mainly by the Labour Offences and Sanctions Act, first implemented in 1988,"'' the Workers' Statute'" and the Prevention of Occupational Hazards A c t . m The 1988 Act describes various violations of labour legislation (particularly as regards work, health and safety, employment and social security) and categorises them as minor, serious or very serious offences. The same Act states that administrative sanctions may include the imposition of fines of varying magnitude and even temporary or permanent closure of the workplace. Offences which have greater social impact are categorized as criminal labour offences in the Penal Code and are subject to penal sanctions. They perform their functions by visiting enterprises or workplaces; they are also officially empowered to institute legal proceedings and to act as mediators or conciliators in industrial and legal disputes.

Ley8/1988de 7 de abril (B.O.E. 15-04-1988), sobre infracciones y tantiemes en el Orden Social; Botetin. Oficlal del Estado de 15/04/19881 http://www.ccoo.es/legislacion/leyorden.litm. Estatuto de las Trabajadores, Real decreto Legislativo 1/1995 de 24 marza. http://www.satse.es/juridico/e_trabajo/estrindi.htm. http://noticias.juridioas.com/base_datos/Labaral/131-1995.html.

Systems for for setting OELs in EU countries 109 SWEDEN 1 7 7 Enforcement Authority

The Work Environment Inspectorate within the Swedish Work Environment Authority (SWEA) is responsible for enforcement of the exposure limits.

Eenforcement powers. Until 2001 the Health and Safety Agency consisted of the central Occupational Health and Safety Board and regional Labour Inspectorates. The Labour Inspectorate had been set up as long ago as 1890 in connection with the adoption of the 1889 Act on Protection against Occupational Risk in Private Industry, and was divided into 10 Labour Inspectorate districts in 2000, Since the amalgamation of the Board and the Inspectorates in 2001 to form the Work Environment Agency, the Inspectorates have ceased to exist as independent authorities. However, they are now local bodies of the Agency and called lokal arbetsmiljoinspektion (Local Work Environment Inspectorates). Within the SWEA, the ten districts of the Work Environment Inspectorate supervise employers' compliance with the requirements laid down in the Work Environment Act and in the Provisions which are issued. This supervision normally takes the form of inspection. In the course of inspection the working environment is most often assessed in a holistic perspective relating to the hazards of the working environment (physical, mental and social hazards) but there are instances of inspection focusing on a single risk (e.g. a particular type of task). In the selection of workplaces for inspection, priority is given to those presenting the greatest risk of ill-health and accidents. Usually the visit is announced in advance by a phone call or letter but the inspector is entitled to come unannounced. Procedure varies, depending on the branch of activity concerned, the size of the organization and other matters. In one undertaking, detailed inspection may be the most important part, in another undertaking systematic work environment management may command most attention. The inspection can also include market control, (e.g. of machinery). The safety delegate must normally be present during the inspection. The inspector gives an appraisal of the working environment and any deficiencies which have been observed. If attention has been

http://www.av.se/english/Files/h367eng.pdf.

110 Beyond Limits 110 drawn to any deficiencies of the working environment, these will also be described in writing, in what is termed an inspection notice. In the inspection notice the employer is given a time limit to report how the work environment deficiencies which have been described have been dealt with or what plans exist for dealing with them. The inspection notice is not a formal decision by the authority but an appeal to the employer to take the measures which work environment legislation requires. The inspection notice cannot be appealed against. If the employer does not rectify the deficiencies mentioned in the inspection notice, the SWEA can issue an injunction or prohibition, an order to remedy the deficiencies or prohibit a certain handling or other operation. The SWEA can also issue an injunction or prohibition of this kind under penalty of a fine. An injunction or prohibition is a formal decision made by the authority and can be appealed against. The record of decision gives the time limit for appeal and indicates where the appeal can be submitted. See Chapter 9 for further details.

T H E NETHERLANDS1™ Enforcement Authority

The Labour Inspectorate, as part of the Ministry, is responsible for surveying and enforcing the OELs.

Enforcement powers. In order to monitor compliance with the Working Conditions Act, the Inspectorate visits premises for inspection purposes, with or without prior announcement. Inspectors may also be requested to make such a visit by a trade union, or the workers' representatives within an enterprise. In most cases, the Labour Inspectorate will first summon the employer to comply with the obligations (eis tot naleving) before imposing an administrative fine. Only in severe violations of the obligations of the Working Conditions Act, will the Labour Inspectorate immediately impose an administrative fine. With respect to specific violations of the obligations as inserted in the Working Conditions Act, the Labour Inspectorate can impose an administrative fine, for example, if the employer (with the support of the Arbodienst) has not made an inventory of the dangerous substances or does not have a working conditions policy. It is empowered to detect contraventions of the law and to draw up

http://www.rninszw.nl/Doci3menten/lTxfonnatie/Arbo/arbeidsinspec/arbeidsinspec.htm.

OELs in in EU EU countries countries 111 111 Systems for setting OELs official reports on them. Under the Working Conditions Act, the Inspectorate may stipulate the manner in which general provisions and technical regulations in the Act must be complied with in practice and may order the cessation of dangerous activities (right of summary enforcement). Apart from this, employees themselves are also entitled to discontinue an activity in cases of imminent serious danger where it is not possible for the Inspectorate to act on the matter in time, hi such cases the employee concerned must then inform the Inspectorate of what has happened. The Labour Inspectorate monitors the level of exposure only in exceptional cases, if reasonable doubt exists about the situation in a company, and the employer is not willing to take measures. Only a small number of companies, mostly larger chemical industries, monitor levels of exposure in everyday practice. The frequency of monitoring varies from business to business. Monitoring mainly takes place within the framework of obtaining background information, to check if the measures taken are satisfactory. However, according to the MAC Commission, when data can be obtained from corresponding situations in other companies in the Netherlands or even abroad, the companies and OHS Services do not undertake monitoring themselves. The reasons given for not monitoring extensively are: that it is too expensive, labour-intensive and it can be unreliable. When the results of monitoring are checked, threshold limit values such as MACs are not used in all cases. See chapter 8 for further details.

UNITED KINGDOM Enforcement Authority

The Health and Safety Executive (HSE)

Enforcement powers. Compliance with OELs is a legal requirement under the COSHH Regulations. Under the HSW Act 1974 HSE inspectors have powers to issue two types of enforcement notice - an improvement notice or a prohibition notice - as well as powers to prosecute for criminal offences in the courts. Improvement notices are normally used to instruct duty holders to remedy a situation in which an inspector believes that there has been a breach of the law resulting in a risk to the health or safety of persons that the law is intended to protect. The duty-holder is normally required to remedy the situation within a specified time period in accordance with the requirements laid out in the notice. Prohibition notices are normally issued where inspectors fell there is an imminent and serious risk to health and safety. They have the effect of prohibiting

112 Beyond Limits 112 the continuation of the activity that is the cause of the risk as well as requiring it to be corrected in accordance with requirements identified in the notice. Failure to comply with either notice is a criminal offence that may result in prosecution. HSE's own analysis of its enforcement record shows that despite their centrality to monitoring and control under COSHH, OELs played only a minor role in the enforcement of the Regulations. Enforcement of chemicals falls within the HSC's enforcement policy statement (HSC 2004)™. The consultative document on WELs stated that in determining the benchmark against which to decide on enforcement action, if duty holders were applying the principles of good practice they would not be exceeding the WEL. But although the WELs would be useful in determining benchmarks - and their breach would indicate a substantial risk gap and enforcement action - the increased emphasis on good practice meant that the judgement would not depend on measured exposure against the WEL. It would also take into account the condition and maintenance of any control measure provided; the provision of adequate instruction, training and supervision, and the consequences of limited health surveillance. COSHH accounted for between 12 per cent and 21 per cent of all enforcement notices each year between 1997 and 2000 (most were improvement notices). Substances with MELs dominated the substances cited in notices, although the enforcement often focused on the process rather than the substance, but the existence of an OEL meant that the substance was likely to become a focus of attention by inspectors. See Chapter 4 for further details.

CONCLUSIONS There are strong similarities between the various systems for setting and achieving compliance with OELs in the EU. This is hardly surprising since these practices mostly derive from the same small number of historical sources. The ACGIH list of TLVs has clearly been of major influence as, to a lesser extent, have been practices in Nordic countries and in Germany. Latterly, the influence of the EU has been responsible for further convergence. These similarities, by no means always override the national

HSC (2004) HSC Enforcement Policy Statement HSC 15, Sudbury: HSE Books.

Systems for for setting OELs in EU countries 113 differences that are apparent in the setting, status and use of OELs as well as in their legal context. Regulatory system and responsible bodies. There is legislation on health and safety in the use of chemical substances in all countries. In most cases it is in the form of some kind of framework provision supplemented by more specific requirements relating to chemical substances. The influence of both the EU Framework Directive and EU Directives on chemical agents is evident in the structure and content of these provisions and in their increased emphasis on process-based approaches to the management of risk. There is further similarity in the broad nature of the responsible bodies involved. National organisations for monitoring compliance with legal requirements on health and safety are present in all countries. They are variously titled - Labour Inspectorates, Work Environment Authorities etc. They usually operate under the authority of a central Government Department or Ministry and mostly have some form of overall responsibility in the setting and enforcement of OELs. There are differences between countries in the extent to which such national authorities: — are regionalised in their operation — deal exclusively with health and safety or with labour inspection of other aspects of working conditions more generally - have specialised field inspectors and support services in relation to chemical safety - are sole enforcing authorities or share this function with other agencies. Similarities are also evident in the role of national research institutes for health and safety, which appear to play a strong, independent, advisory role in the setting and adoption of OELs in most countries. One significant difference between countries is found in the role of social insurance associations. Their engagement in regulation is most marked in German model (also evident in Austria), where they have both rule making and enforcement authority in addition to that of the state inspectorate, The French approach and the role of the CNAM/CRAM share some of these features in its emphasis of the powers of the social insurance bodies. Another departure from the predominant pattern of organisation of regulatory structures is found in Italy where in practice the responsibilities for seeking compliance with health and safety provisions lies with regional and local structures of the public health system (although the Labour Inspectorate has some national responsibilities as well as some residual shared role in especially hazardous sectors).

114 Beyond Limits 114 What impact, if any, these differences have on regulatory practices in relation to OELs will be explored in the following chapters covering five countries that together display most of the range of these features.180 A further difference is seen in the role of external prevention services in matters concerning OELs. It is clear that in countries where there is a legislative requirement or strong tradition for integrated occupational health services as part of the national health and safety system, it is anticipated that they will play a significant role in helping firms achieve compliance with requirements that involve OELs. This would appear to be the case in Nordic countries and in the Netherlands. It also appears to be the aspiration in some southern European countries such as Spain and in Greece (although it is questionable whether there is sufficient infrastructure in place to allow this). At the opposite extreme, in terms of the formal arrangements governing the role of prevention services, is the situation found in the UK and to a great extent also in the Republic of Ireland, where formal provisions are minimal and considerable discretion is wielded by employers in the use of such services or otherwise. In these latter cases the issue of competence of prevention services and personnel is largely determined through the role of professional bodies and the market rather than formal legislative interventions such as in countries like France and Germany.' Despite this largely voluntaristic approach, it is clear that the role of OHS professionals in the development of OELs in the UK has been considerable. Their role in implementation and use at the workplace level is more difficult to determine. Nevertheless, at least in large workplaces where chemicals are used, there are strong indications of their significance. The primary reasons for the prominence of professionals in this respect are related to the history of the development of the profession of occupational hygiene in the UK and its close association with parallel professional development in the US, rather than with the development of professional interests in occupational health and safety in continental Europe. The rise of the occupational hygiene profession in Britain was supported by the development of large industrial establishments with centralized support services with both sufficient resources and demonstrable market based need to employ occupational hygiene specialists. This in turn allowed the professional bodies representing their interests to achieve prominence in industry and national bodies. Change in the structure and management of organisations has led to fragmentation, downsizing and the outsourcing of services, alongside a major decline in the size of the engineering and manufacturing industries in countries such as the UK. This means that there is no longer Unfortunately it has not been possible to include France in the examples of countries chosen for more detailed study and therefore it is not possible to comment on the significance of the involvement of the CNAM/CRAM.

Systems for for setting OELs in EU countries 115 such a large niche for occupational hygienists that can be supported by industry on either a structural or economic basis. The resulting decline in the size of the profession in the UK is evidence of this. The implications of these changes will be discussed in subsequent chapters that inter alia explore the evidence for the role of prevention services and professionals in supporting enterprises in chemical risk management and especially in relation to the use of OELs. Procedures for setting OELs. Another strong similarity is seen between countries in the way in which they have set up their structures for setting or adopting OELs to allow for considerable stakeholder participation. These structures are mostly based on tripartite models, with the addition of 'independent' expertise. Other agencies such as insurance associations also may play a greater or lesser role depending on the broader national health and safety system. In countries in which OELs are set there are also broad similarities in the procedures involved. Mostly there is a two stage processes in which the scientific/health-based issues are dealt with, usually by 'experts* (sometimes representing economic interests sometimes not, and sometimes a mixture of both) and a second process in with economic/technical issues of feasibility are considered. Here economic interests are always represented and the social partners are much in evidence. There are two broad patterns evident in the 15 countries studied. There is a group of countries in which there are detailed procedures in place for both setting and complying with OELs. These are essentially the larger northern European countries, the Nordic countries and the Netherlands. These too are the major players when it comes to setting limits at the level of the EU. There are several other countries for which this is far less the case. Their systems vary in detail, but generally they consist of structures and procedures in which expert and stakeholder representation is in place although the nature of the decisions they take may be different to those in the countries with more developed systems. There was clearly some concern in countries with less developed systems about adequate scrutiny of the meaning of values adopted from the EU. There was also concern about the continuation in force of values that could be traced to older lists of the ACGIH and for which there is now new scientific evidence concerning the effects of exposure. Indeed, such has been the widespread historic use of TLVs that the speed with which these can be reviewed and, if necessary, replaced is of concern in most countries regardless of whether or not they currently set their own new standards. At the same time, in countries such as Italy there seems to be another level of concern about the meaning and use of OELs as legal standards. This derives from a fear that adoption at national level of EU 'pragmatic* standards that take economic considerations into account will undermine the Italian workers' constitutional right to healthy and safe workplaces. According to this argument the assumption of a risk level

116 Beyond Limits 116 that is implicit in such standards is fundamentally at odds with workers' rights to health that are enshrined in the constitution. We return to this issue in greater detail in Chapter 7, which deals in greater detail with the Italian situation. Occupational Exposure Limits, As far as the limits themselves are concerned there are differences of detail in the values adopted. We have not explored the reasons for such differences or their practical significance. Terminology used to define them is international such as time weighted averages, short-term exposure limits, ceiling values and annotations for special risks such as carcinogenicity, skin absorption, allergenic substances etc. but there are differences in the detail of its application to different substances in different countries. Further comparative study would be required to explain the significance of such detail. Legal status of Occupational Exposure Limits. In most countries there are a number of OELs that are legally binding limits. Sometimes they are restricted to those that are in force as a result of compliance with EU Directives but in many cases the list is larger. In the guidance that accompanies OELs in all countries in which it was available, it is made clear that they are not regarded as safe limits and they are frequently accompanied by recommendations to reduce exposures to as low as is possible below the limit. In some countries there is more than one kind of limit with legal meaning as in the situation until recently in UK (although not necessarily with the same definition applying), m others there is only one limit that has a legal definition but there may be others that have the status of guidance. It is not clear from information available whether this has a significant or measurable impact on the use and enforcement of limits. Nor is it clear whether it affects the understanding of the meaning of limits by users. These are issues to which we shall return in the more detailed country studies that follow. Further differences reflect broader variation in the regulatory systems of the countries. Thus in Italy, older OELs derived from the ACGIH list may be legally binding in some sectors because they are referred to in collective agreements which themselves have a legal status within the Italian labour relations system. In the Nordic countries, the long tradition of Nordic corporatism also means that the detail of OELs that apply may be found in collective agreements. In the Netherlands the social partners have achieved an agreement on the controversial use of OELs in relation to nonsubstitutable carcinogens in which a certain level of risk is accepted in exchange for the likelihood of increased safe working environments overall. The social partners agreed to strive for TLVs corresponding to risks not larger than 10"6 per year (or 4 x 10"5 for the working-life as a whole). However for the time being, as such low risks are not achievable for many carcinogens, TLVs that correspond to risks up to 10"4 per year (or 4

Systems for for setting OELs in EU countries 117

x 10 for the working-life as a whole) are tolerated at present. (A risk of 10 per year roughly equates to the average risk for a fatal work accident in the Netherlands.) Since 1996, about 15 TLVs have been derived under this scheme (Wilders 2002). In Germany so-called TRK values have been derived for more than 70 carcinogens. Only recently has the decision for a systematic review of these limit values been taken. It is likely that more than 10 years will be needed to revise all of them and therefore such review will tend to become a permanent feature of the German system (Wriedt 2003) Who enforces the exposure limits, enforcement activity and what is meant by compliance? As already pointed out it is the national labour inspectorates (or their equivalent) that have enforcement authority in all countries although this may be supplemented in various ways by other agencies. The extent of the use of these powers and penalties is much more difficult to determine. Enforcement activity in general has proven difficult to document from the sources available to us. We have been imable to obtain a detailed picture of enforcement practice from any of the countries studied. In the chapters that follow we document, as far as is possible, the situation from information available. What is clear from the overview in this chapter is that while OELs are part of the enforcement scenario, in most countries the way in which such enforcement is undertaken varies. In some cases the emphasis of inspectorates is on firms achieving compliance with requirements concerning the management of the overall processes of production. Compliance with OELs as such, is therefore evidence of health and safety management working effectively, as lack of compliance would indicate the opposite. They are also enforced (at least in theory) in their own right, where there is evidence that they may be exceeded. Again, it has not been possible to determine from records, with what frequency such action takes place. There are situations in which measurement of airborne pollution will be required to assess and manage risks. While this is the responsibility of employers, in practice it is often undertaken by external expertise and the role of prevention services to which we have already referred is important in several countries. Generally, it seems that regulatory inspectorates rarely engage in proactive acts of monitoring compliance with specific OELs themselves. However, where there is concern over workplace airborne pollution that may be approaching or exceeding limits, there are requirements in some countries to inform and involve the regulatory agencies in monitoring. The extent to which technical aspects of monitoring actually take place, either with the involvement of the regulators or the prevention services (or their equivalents) is not clear. These issues are discussed in the specific cases of the countries that are the subjects of the following six chapters.

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119 119

THE UNITED KINGDOM

INTRODUCTION The UK chemical industry is the third largest in Europe, after Germany and France, accounting for some 14 per cent of production in the EU. Chemical substances are also used by large numbers of workers in other industrial sectors as well as in services. HSC has estimated that there are some 1.3 million firms that use chemicals and chemical products. Many of these are small and micro enterprises. According to the European Foundation's survey of working conditions about 20 per cent of British respondents thought they were exposed to breathing in fumes, dusts or dangerous substances for a quarter or more of their work-time which is slightly less that the average for the EU 15 countries as a whole (22 per cent). While somewhat more than the average for the EU 15 countries (nearly 20 per cent) thought they handled dangerous products or substances in their work (EU 15 - 15.6 per cent) (European Foundation 2001). In this chapter we consider the role of OELs in the system for regulating the management of risks of hazardous substances in UK workplaces. As in several other countries, regulatory status was attributed to OELs in the 1980s in the UK. But perhaps more than in other countries, the limitations of this regulatory role have been the subject of considerable scrutiny and policy change. In seeking to understand the recent shifts in the position of OELs in regulatory policy it is necessary to trace several related narratives in the story of their use in the UK. They include the history of their application, first as non-regulatory tools to inform good occupational hygiene practice, through their acquisition of regulatory status and a role in regulating the management of hazardous substances, to the gradual recognition of their limitations and that of the system in

120 Beyond Limits 120

which they were incorporated. There is a body of research available in the UK that explicitly addresses the ways in which OELs are perceived within workplaces and their role in the management of chemical risks. There is also some evidence available on the extent to which OELs have featured in enforcement actions undertaken by regulatory inspectors in the UK. Additionally, approaches to the role of OELs have been much discussed in the specialist and practitioner literature in the UK and in particular, the views of senior regulatory policy makers have been articulated. Equally significant in the UK is the synchronicity of strategies on OELs with wider policy considerations in health and safety regulation generally. It is evident that the regulation of risk management in relation to hazardous substances resonates with such wider considerations and a proper understanding of recent reforms in relation to the role of OELs is therefore incomplete without its contextualisation within this wider scenario. These related themes are the basis of this chapter. It begins with the development of the regulatory background to chemical risk management in the UK. Then it focuses on the system for setting of OELs and their role within regulatory strategies. A discussion of the empirical evidence of the understanding and use of OELs in Britain follows before some consideration is given to recent shifts in policy approaches.

BACKGROUND: LEGISLATIVE REFORMS FROM THE 1970S The UK has the longest history of legislative intervention in occupational health and safety in the world. It is hardly surprising therefore that it has deeply rooted and characteristically British features. They include a high degree of voluntarism and discretion afforded to actors in the system and a relatively low level of regulatory intervention on the part of the state. In contrast with the other countries in this study, the legal framework for regulation is affected by, amongst other things, the common-law basis of English law and the relative absence of a preventive role for social insurance. For the past thirty years the framework for prevention has been dominated by the requirements of the Health and Safety at Work etc. Act 1974 (HSW Act). This Act, widely regarded as a radical departure from previous prescriptive requirements at the time of its introduction, is still viewed by government and national level policy makers as a success, having 'stood the test of time' with its style and requirements regarded as relevant today as they were when they were introduced in 1975. Regulating the management of

Y2\ The United Kingdom 121

the risks of hazardous substances, while the subject of separate and detailed Regulations, occurs within the framework provided by the Act. It is therefore important to outline something of this framework and the thinking behind it. In 1972 the Committee of Inquiry on Safety and Health at Work - the Robens Committee - produced a report which heralded a significant change of approach in British health and safety regulation (Robens 1972). It recommended the introduction of measures that would: — provide a more self-regulating system for health and safety — ensure wider coverage of all affected by the risks associated with work — clarify duties and obligations for health and safety in a single comprehensive framework — enable a greater degree of involvement of employers, workers and their organisations in organisation of health and safety — provide a national authority for health and safety. Prior to these recommendations, health and safety regulation in Britain had, since the previous century been essentially based around piecemeal prescriptive measures. They were complex and sometimes incomprehensible to the people affected by them, often with incomplete and overlapping coverage, produced with little involvement from either those they were intended to protect or those whose activities they were meant to regulate and with limited procedures for their enforcement. It was largely for these reasons that the Robens recommendations were much vaunted as a radical departure from traditional approaches to health and safety regulation. The Health and Safety at Work etc. Act 1974 (HSW1974) introduced a reform in which the prescriptive standards of older and more narrowly focused legislation were replaced by goal setting approaches, based around regulating the processes of self-regulation.181 Its main requirements were a set of general duties found in Sections 2 to 9 covering employers, employees, the self employed, controllers of

However, not all ita provisions were the result of the Robens Recommendations. For example, the measures in the Act concerning the rights of recognised trade unions to appoint health and safety representatives (Sections 2(4) and 2 (7) ) derived not from the recommendations of the Robens Committee, but from an undertaking to the trade unions on the part of the Labour Government to introduce them following a long trade union campaign on the matter (Walters 2004).

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premises, and manufacturers and suppliers of articles and substances used at the workplace. These general duties were mostly based on principles of common law concerning the duty of care established over the years through damages litigation in the courts, rather than being drawn from previous statutes. Their inclusion in the Act gave them a preventive function. The rationale of this approach was to give everyone concerned with health and safety at work clear, concise and accessible notions of their basic legal obligations. It was also intended to facilitate greater attention to the management of health and safety. The obligations on employers were detailed in Section 2 and required them to provide, so far as reasonably practicable, for the health safety and welfare of their employees. The means by which they were required to do this was identified in general terms with regard to such things as the provision of plant, systems of work, information, training, supervision, access and egress, the working environment and the use of articles and substances. The latter measures were supplemented by the duties of suppliers found in Section 6 of the Act, which laid duties on the designers, manufacturers importers and suppliers of articles and substances for use at work and were intended to introduce protective measures at source. Since the Act came into force this principle has been strengthen by amendments introduced by the Consumer Protection Act 1987, and more specifically in relation to hazardous substances by the Chemicals (Hazard Information and Packaging for Supply) Regulations. Employers were required further under Section 2 (3) to have a written policy in which the organisation and arrangements with which they intend to carry out their duties were identified. The Act enabled the Secretary of State to approve Regulations in which the details of specific legislative standards could be spelt out. An innovation of the Act was its provision for the use of Approved Codes of Practice (ACOPs), instruments that do not impose legal duties, but which set out the means by which a legal duty may be accomplished. ACOPs generally accompany major new sets of Regulations and their provisions relate to those in the Regulations, hi the event of a breach of one of the Regulations made under the Act that is accompanied by an ACOP, the normal direction of the burden of proof is in effect reversed and the defendant is required by the court to show that the means used to discharge the relevant duty were equivalent to those laid down in the ACOP. In the case of hazardous substances, the main requirements controlling their use in British workplaces (and giving OELs regulatory status) are found in the Control of Substances Hazardous to Health Regulations 2002, accompanied by an ACOP that details the way in which duty-holders must implement them. The Regulations were originally introduced in 1987 by the Secretary of State under the powers in the HSW. They

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have been revised and re-enacted several times. As we shall outline subsequently their most recent revisions have been the subject of discussions over the past two years and new COSHH Regulations, including a revised position for OELs are anticipated by April 2005. Other relevant sections of the Act (Sections 10 -14) concerned the creation of the HSC and the Health and Safety Executive (HSE). The HSC, a tripartite body on which the interests of governance, capital and labour were represented, itself spawned a structure of advisory committees with a similar tripartite composition.182 Of particular relevance to hazardous substances and OELs is the Advisory Committee on Toxic Substances, and its sub-committees, including the Working Group for the Assessment of Toxic Chemicals (WATCH), in which deliberations on setting OELs took place (see below). The Act concentrated the previously disparate structure and operation of inspection and control of health and safety, into one central Authority, the HSE and gave its inspectors greater range of formal enforcement actions. There is some evidence in the UK concerning the extent to which OELs have featured in such actions.

REGULATING RISK MANAGEMENT OF HAZARDOUS CHEMICALS Although the HSWAct was generally concerned with the regulation of the process of managing health and safety at work, it contained little in the way of specific requirements on duty holders on exactly how such management was to be undertaken. Moreover, in 1979, several years after its introduction, a Conservative government took office. Throughout the seventeen years that followed, when a succession of Conservative Governments remained in power in the UK, a neoliberal and deregulatory political agenda was pursued, in which there was little room for further development of home grown legislative innovations on OHS management. Instead, the stimulus for reform in this direction was taken over by the European Community, which played a dominant role in instigating the legislative development of process regulation.

The approach to representation on such committees as on the HSC itself has broadened somewhat since their original creation in 1975, with representation from other stakeholders being included in addition to the representatives of trade unions and employers in many of the committees.

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How much this influence was truly extra-territorial in its origins is difficult to document. The extent to which national influences on European Community regulatory strategies can be traced is limited by the lack of transparency of the forums in which decisions were taken.183 However, at a time of intransigent political opposition to further legislative development in the UK, senior HSE policy makers and regulators would have been aware of other avenues of influence (Rimmington 2003). Their role in the consultative machinery of the European Community certainly gave them an opportunity to exercise influence at this level and it is likely that they would have used it to promote a British version of process regulation in the various legislative measures being developed at this time. Amongst the most prominent of these was the EEC Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work. Hazardous substances therefore became one of the first subjects on which the further development of the regulatory approach to mandating more detailed requirements along the lines initiated by the approach of the HSW Act was focused. In 1984 the HSE produced draft regulations seeking to control substances hazardous to health and initiated a protracted period of public consultation that was to lead to the eventual adoption of the Control of Substances Hazardous to Health Regulations (COSHH) in 1987. There were several features of the regulations and the consultation that are central to understanding the British approach. To begin with the influence of the EC was clear. The Regulations were a response required to by British membership of the European Communities to the EEC Directive 80/1107/EEC. At the same time, the main thrust of the requirements was to regulate the management of hazardous substances at the workplace. This was to be achieved through incorporation of general principles of good occupational hygiene practice, and requiring assessment of the risks of exposure, It is further complicated by the extent to which the 'diplomacy' of Commission officials obscures the realities of influence in deciiions at this level. As Walters shows in his analysis of the development of the content of the Framework Directive many national representatives that took part in this process, often with opposing views were led by Commission officials to believe the emerging Community strategies in relation to the content and purpose of the Directive reflected their particular input and interests (Walters, ed. 2002).

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use of adequate control measures and their maintenance as well as instruction, information and training for workers184. Indeed such was the profile of the debate surrounding many of these issues that the proposed COSHH Regulations became the defining health and safety legislation of the 1980s, as significant in that decade as the Act had been for the 1970s. Although the COSHH Regulations have been the subject of several subsequent revisions (for example in 1994,1999, 2002 and again in 2005), their basic message remains the same. While thinking from within the European Community may have been a strong influence on the orientation of the content of the proposed Regulations, it was by no means the only stimulus for their introduction. The HSW Act was gradually introduced to repeal and replace the largely prescriptive existing British provisions with modernising measures. Existing chemical regulation was of this kind and there was a widely held view that it was outdated, over-complex and obscure. The proposed regulations were therefore also part of this modernising process. hi addition, the quasi-technical nature of the approaches to risk assessment and management that regulations on the control of hazardous substances required, reflected notions concerning the demarcation of the subject matter of health and safety with which British regulators felt comfortable. Chemical substances, good occupational hygiene practice, assessment of exposure, use and maintenance of control measures and health monitoring were all issues that seemed to be unequivocally concerned with technical aspects of health and safety and uncontroversial in this respect.lss

These kinds of requirements were to become a famiKar refrain in UK regulatory measures over the next decade as the UK. sought to implement a succession of EEC Directives in which the regulation of the process of OHS management was increasingly specified. Early examples dealt with particular physical and chemical hazards such as asbestos and noise. The approach was later consolidated in the requirements of the Framework Directive 89/391 where it was applied to employers' duties to manage health and safety more generally and in the succession of daughter directives that were made under it (see Walters ed., 2002). In contrast with the debates that were to come over the wider remit of risk assessment that would be used in relation to future more generic directives on OHS management such as the Framework Directive 89/391.

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Our particular interest in the subject matter of the regulations focuses mainly on assessment of exposure. It was in relation to such assessment that OELs were to assume regulatory status. In the following section we explore the way this came about. Before doing so it is also important to account for a second and related element in the evolving British regulatory approach to managing the risks of hazardous substances at work. This concerns the development of requirements on manufacturers and suppliers to provide information concerning the safe use of their products. They had general obligations to do so under Section 6 of the HSW Act and their obligations were further detailed in a series of regulations that at the same time sought to implement European Community requirements. The Regulations dealing with suppliers' information that were developed contemporaneously with COSHH were the Chemicals (Hazard Information and Packaging for Supply) Regulations 1994 (CHIP). Amongst their features was their implementation of the EC classification system for the toxicology of chemical substances. This system, based on clearly defined criteria agreed throughout the Community, offered an internationally recognised and accepted means to classify the nature of the toxicological hazard represented by individual substances supplied for use at work. As we mentioned in the previous chapter, its approach used a codification system (Risk Phrases) that was based on toxicological evidence of harm arising from exposure to substances. Criteria for codification were set out in Annex VI to the Dangerous Substances Directive (67/548/EEC) as amended by its Seventh Amendment (92/32/EEC). Annex I to the Dangerous Substances Directive included risk phrases (R-phrases) for all substances with an agreed hazard classification in the EU. This information was reproduced in the UK in the Approved Classification and Labelling Guide (Third Ed.) whilst specific substances and their R-phrases were listed in the Approved Supply List. If any substance supplied to a workplace within the European Community was not listed in Annex I to the Directive, the supplier was required to consider whether a hazard classification was appropriate and if so, based on the classification criteria, apply the appropriate R-phrases as well as other information. Amongst other things then, CHIP required that suppliers classified the substances they supplied according to the extent of hazard they represented to human health. It required they used the R-phrase rating system to do so and that suppliers state the appropriate R-phrase on the Safety Data Sheets they were obliged to provide when supplying chemicals or preparations for use at work. These measures were to be of considerable significance in relation to the future policy expectations

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concerning the role of OELs at the workplace level, particularly in small enterprises. COSHH and the development of the regulatory status ofOEL. Prior to 1984 the HSE used the ACGIH list of TLVs as the basis for a non-regulatory Guidance Note on exposure limits. A condition of the use of the ACGIH list was that it could not be altered in any way. As Silk (1987) pointed out during the discussion concerning the draft COSHH regulations, this condition created several difficulties for the UK regulatory strategy on hazardous substances. Different values had in fact already been adopted for a small number of substances. Time weighted averages were sometimes based on different periods and legally binding Control Limits for some substances, created further difficulties in using the list as voluntary recommendations. A consequence of these difficulties was the decision taken in 1980 to publish an independent British list of exposure limits with its own notes on the thoughts behind their adoption and application. The first edition of this list was produced in HSE Guidance Note EH40/84 that appeared in the same year as the consultative document on the future COSHH Regulations. It contained two categories of exposure limits - Control Limits for a small number of substances (about 20 in the first list) that had exposure limits with some regulatory status and Recommended Limits for the remainder of the 500 or so substances that were contained in EH 40/84'86. Control Limits represented limits that should not normally be exceeded and should be achieved by application of appropriate plant and process control techniques - although it was recognised that there may be special circumstances (such as maintenance operations for example) where such measures were not reasonably practicable. Under such circumstances the guidance indicated that 'the use of suitable personal protective equipment was acceptable in order to achieve compliance.' Recommended Limits were ' . . . considered to represent good practice and realistic criteria for the control of exposure, plant design, engineering control and if necessary the selection and use of personal protective equipment.' Of particular relevance to our interest in the use of such limits was the statement:

Although 'an independent British list' it was nevertheless largely based on the adoption of limits from the TLV list of the ACGIH. This was coupled with the commitment of WATCH to gradually review the evidence for these limits and to replace them and establish new limits for additional substances as appropriate.

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'HSE inspectors will use these exposure limits as part of their criteria for assessing compliance with the HSW Act and other relevant statutory provisions'. Both types of limits were adopted on the advice of ACTS. In order to be able to keep the list under regular review, the previously mentioned WATCH subcommittee of ACTS was required to consider changes to recommended exposure limits already listed and to propose limits for further toxic substances that had significant use in the occupational environment. Such was the situation between 1984 and the time that the COSHH Regulations came into force in 1988. The Regulations represented a significant milestone in the history of the use of OELs in the UK because they gave them a clear role in requirements on duty-holders to manage occupational risks of hazardous substances. OELs were thereby transformed from mainly voluntary standards intended primarily for professional use into standards with an unambiguous legal status. The rationale for this was essentially that regulating control of exposure to hazardous substances would require duty holders to maintain control measures to the extent necessary to give adequate protection for the health of workers. Within the COSHH requirements therefore there would be a legal framework for workplace OELs. As an HSE spokesperson stated in a paper presented to the Annual Conference of the BOHS (Rolt, 1986): "The obvious way of setting clear standards in respect of one aspect of control is by means of occupational exposure limits' However, he acknowledged that there were a number of difficulties in doing so that were presented by the definitions of Control Limits and Recommended Limits then in use and argued that the nascent COSHH Regulations represented an opportunity to review policy and rationalise the definitions and legal status of OELs. That was in effect what happened, hi a letter to the Annals of Occupational Hygiene in 1989 seeking to clarify the position with regard to the new occupational exposure limits and the indicative criteria used to set them, following the implementation of the COSHH Regulations, the HSE Chairman of ACTS stated (Carter 1989):

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'The COSHH Regulations introduce two new classes of occupational exposure limits: maximum exposure limits (MELs) and occupational exposure standards (OESs). Both of these new limits apply to exposure via the inhalation route and will be used in determining whether exposure has been adequately controlled, if it is not feasible to prevent it altogether. For substances that have been given MELs, the level of exposure should be reduced so far as is reasonably practicable and in any event should not exceed the MEL. For substances with OESs it will be sufficient to ensure that the level of exposure is reduced to the OES.' The so called indicative criteria that would be used to as a guide to assist WATCH and ACTS in deciding whether to recommend an OES or MEL for a particular substance to HSC, were also defined: For a substance to be assigned an occupational exposure standard it was required to meet all of the following: i. The ability to identify, with reasonable certainty, a concentration averaged over a reference period, at which there is no indication that the substance is likely to be injurious to employees if they are exposed by inhalation day after day to that concentration ii. Exposure to concentrations higher than that derived under criterion 1 and which could reasonably occur in practice are unlikely to produce serious short or long term effects on health over the period that it might be reasonably taken to identify and remedy the cause of excessive exposure iii. The available evidence indicates that compliance with the OES, as derived under criterion 1 is reasonably practicable. For a substance to be assigned a maximum exposure limit it was required to meet either of the following: i. A substance not able to satisfy the criteria for an OES and which has, or is liable to have, a serious risk to man including acute toxicity and/or potential to cause serious long-term health effects; or ii. Socio-economic factors, which indicate that, although the substance meets the criteria for an OES, a numerically higher value is necessary if certain uses are to be reasonably practicable. The two types of OEL introduced by COSHH, - the OES and MEL - were both expressed as airborne concentrations averaged over a period, either a long term

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exposure limit (an eight hour time weighted average) or a short term exposure limit (with a 15 minute reference period). OESs would be set for substances for which it was possible to identify with reasonable certainty a concentration of exposure at which it was judged there was no significant risk to health and with which it was reasonably practicable for industry to comply. Where such a concentration could not be identified and the chemical had serious health implications an MEL would be considered. Because the OES was considered a 'safe' concentration employers were required to meet this standard for each substance for which one was set but not necessarily control the concentration of such substances in workplace air to levels below the standard. It was also permissible for them to exceed the standard provided steps were taken to remedy this as soon as reasonably practicable. In contrast a MEL indicated a concentration that must not be exceeded. Furthermore, duty-holders were required to reduce concentrations in workplace air of substances with MELs to as low as reasonably practicable below the MEL. HSE spokespersons such as Michael Topping (2001) referred to the notion of 'tolerability of risk' that could be applied to aid understanding of the role of OELs in policy on controlling the risks from chemical hazards.187 In his conceptualisation, the nature of risk increases from what is negligible to that which cannot be ethically justified (except in extraordinary circumstances). In this process the social acceptability of the risk passes through a range from being broadly acceptable through being tolerable to becoming completely unacceptable. As Figure 4.1 shows the notion of tolerability is not a single point on this scale but a broad band through which what society might deem tolerable decreases as risk increases. In this scenario the definitions used to set OESs would place them at the end of high tolerability because by definition they are intended to represent 'safe levels.' However, MELs are set at a point where a much greater level of risk is acknowledged. They are therefore at the boundaries of tolerability, must not be exceeded and are borne in conjunction with the requirement that control measures are required to drive the risk in the direction of greater acceptability. If a residual risk remains in this region and at the same time society desires the benefits of the activity causing it, the residual risk is only tolerable if further risk reduction is

Although originally developed to explain policy on controlling the risks of major hazards such as those of the nuclear industry in the light of societal concern, Topping argued it could equally well be applied to to aid understanding of the role of OELs in policy on controlling the risks from chemical hazards

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impracticable or requires action that is grossly disproportionate in comparison with the risk reduction so achieved.188

Figure 4.1: HSE's Tolerability of Risk Framework and OFXs (after Topping 2001)

Risk cannot be justified except in extraordinary circumstances

Unacceptable region

Maximum exposure limit Control measures must be introduced to drive residual risk towards acceptable region. IF residual risk emains and the henefit of the activity is desired it is tolerable only rf further sk reduction is impracticable or equires grossly disproportionate esources.

Tolerable region

Occupational exposure standard Broadly acceptable region

Level of residual risk is insignificant. Further efforts to reduce risk are likely to be grossly disproportionate to the risk reduction achieved.

Negligible risk

Of course this sentence is laden with value judgements that as critics of the risk tolerability framework have pointed out are socially determined and imply an equal distribution of information, power, influence and control in decision making processes and their social and economic underpinnings that critics also argue to be a far cry from reality.

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Under the COSHH Regulations the statutory status of OELs in the UK was complete. They defined adequate control of risk by inhalation of the hazardous substances to which they applied. Processes that had evolved over the previous decade or so for setting and adopting OELs were now linked to a legal framework for their use. Thus, according to Topping (2001) the limit setting process involved the HSC, ACTS and its sub-group WATCH - representing the interests of the regulator, employees and employers as well environmental interests - and were supplemented by a further public consultation on the limits derived from this process. As shown in Figure 4.2 the process for setting limits for any particular substance would be initiated by a package of information supplied by the HSE to WATCH. If the committee considered that the substance met the criteria for an OES, a value would be recommended to ACTS. If the recommendations were agreed they were published in a widely circulated consultation document. Following this public consultation HSC would endorse the proposal, publishing it in the annually revised Guidance Note on OELs. If WATCH were unable to recommend an OES for a particular substance it would be referred to ACTS for further consideration, normally for setting an MEL. If ACTS agreed to set a MEL the HSE was required to issue a Chemical Hazard Alert Notice (CHAN) as an interim measure to inform industry of the serious health risks associated with the use of the substance (if eventually ACTS decided not to issue a MEL because for example, the resources required to do so were not justified, employers would nevertheless be expected to establish appropriate control regimes based on the CHAN). If a MEL were to be set for a particular substance, the HSE was required to gather information on good occupational hygiene practice in relation to its use, and make proposals for the MEL. A regulatory impact assessment would be undertaken, setting out the socioeconomic factors balancing risks to health against costs of reducing exposure. These proposals would then be considered by ACTS and subsequently also the subject of public consultation before being endorsed by HSC and published in EH40.

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HSE prepares data package

WATCH propose values for OES or or refers substance to ACTS for further consideration YOU AREto normally set toHERE set MEL

on ACTS (2001) Interests represented on Employees — — Four TUC nominees

Employers — — Four CBI nominees ACTS endorses OEL OEL proposals Agrees to to issue CHAN is is MEL MEL is is considered appropriate and and proposes value for for MEL

Public consultation on on OES OESand and MEL

— Local authorities — Two Two local government nominees

— Environmental interests — by HSE) representative (selected by

One One

Consumer interests —One representative by HSE) (selected by

Independent experts — — by HSE) representatives (selected by

Five

HSC endorses OES MEL OES and and MEL proposals. They are are then EH 40 published in in EH 40 occupational occupationalexposure exposurelimits limits

In practice this meant that when COSHH was adopted, the existing list of Control Limits became MELs.189 The Recommended Limits were reviewed to identify and remove any substances with limits that did not meet the new criteria for OESs and the remainder (around 500) became OESs without any further scientific review. Except those for lead and asbestos, which are covered by separate Regulations.

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The ones that had been removed were subject to further review in the years following. Problems with OELs under the COSHH system. Although the COSHH Regulations were a landmark development in regulatory approaches to OHS management and an important milestone in the history of the use of OELs, this is not to say that they were without problems. Significantly, several of these problems, which gradually came to light in the years following the implementation of the regulations, were directly associated with the process for setting the two kinds of OEL. To begin with, in the application of the indicative criteria for setting an OES, WATCH operated on the principle that for the first criterion to be met (that is for an OES to be set at a level based on an average concentration over a specific reference period at which there is no indication that the substance is likely to be injurious), it must be possible to identify a 'safe' concentration from the available data. However, in practice what was actually known about the toxicity by inhalation of some substances was relatively limited and it was found increasingly difficult to identify with any certainty a level that was of no concern to human health for such substances. At the same time not all such substances would have serious health implications for those exposed and would not warrant a MEL on such grounds. There was therefore a gap into which an increasing number of substances fell that could not be awarded an OEL of either kind. Moreover, as we have indicated previously, as time passed the whole concept of a so-called 'safe limit' became increasingly insecure. In reality it was not possible to give such a guarantee for substances, because of gaps in knowledge about their properties and also because of the extent of human variability. Further problems arose as a result of the parallel standard setting process developed at the European level during the 1990s. The emergence of the Chemical Agents Directive, obliging member states to set limits at levels taking into account of those in the IOELV Directives, was not entirely congruent with the British OES/MEL approach. While most substances identified in the IOELV Directives were considered by WATCH to meet the criteria for an OES, there were some that did not and as a consequence would have to be considered for an MEL even though the European SCOEL had concluded that a health based limit could not be set for such substances. Such problems added weight to the growing feeling that the criteria used to decide which limit was appropriate were insufficient in scope.

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As a result a growing number of substances met neither criteria for an OES or MEL and it was not possible to establish an OEL for them. However all these problems associated with setting OELs were relatively minor compared with the implications of evidence that began to emerge in research on what actual use was made of them by duty holders under the COSHH Regulations. Such findings indicated that despite the sophistication of the standard setting processes for OELs and the efforts to make the process of decision making as representative as possible of user interests, knowledge and appropriate use of OELs in risk management at enterprise level could not be taken for granted.

USING O E L S AT THE WORKPLACE The view was widely held that the COSHH Regulations was a major feature of the regulatory framework in the UK by the end of the 1980s. They went a long way to meet the views of practitioners, trade unions and regulators that a workable regulatory framework to control the risks of hazardous substances had been put in place in which a British conceptualisation of OELs was firmly embedded.190 However, there were clearly several preconditions that would need to apply before the COSHH Regulations were going to be entirely successful in practice. These could be divided into three broad areas. The first and most obvious of them concerned the understanding of their requirements amongst users. Nowhere was this more apparent than in relation to OELs. A level of competence would be necessary to enable duty holders to discharge their duties properly. This would be particularly important in relation to the implementation of the principles of occupational hygiene that were central to the approach of the Regulations to chemical risk management. Second, a flow of information concerning the risks of chemicals and how to manage them that was suitable and sufficient to enable duty

The Regulations were of course not without their detractors amongst the organisations representing employers and especially those representing the chemical industry. However, even here the criticism and concern wag not so much directed at the role of OELs as it was more widely directed: at for example, the notion that under COSHH all chemical substances were treated as 'dangerous' because the regulations concerned themselves with hazards rather than raks and therefore placed unnecessary and unacceptable burdens on the resources of the chemicals industry and the users of chemicals.

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holders to carry out their duties was required. As well as employers being provided with this information, as duty holders, they too would need mechanisms in place to ensure its receipt, understanding and use by employees and their representatives if those who worked with hazardous chemicals were to play their part in ensuring the application of the requirements of the Regulations in their own work. Third, the extent to which OELs featured in the enforcement actions on management and control of the risks of chemical substances would help to determine the seriousness with which they were regarded by duty-holders. Initial reviews of the implementation of the COSHH regulations broadly suggested that they had been effective in alerting many employers to the health risks of hazardous substances used in their workplaces (HSE 1993). However, such reviews did not assess users' understanding of OELs or the way they were actually used in controlling chemical risks. During the 1990s there was mounting scepticism about whether OELs were really being widely used in the way they were intended to be under the COSHH Regulations. Several aspects of this concern related to all three areas of the preconditions identified above. Access to information. As already noted, under the HSW Act there is a legal framework governing the flow of information concerning safe use of hazardous chemicals that begins with the supplier of chemical products - flows to the employer but is also intended to inform the workers who are the end users to enable them to use chemical products safely. Both suppliers and employers have specific duties on the provision of information. There are further requirements on training and supervision that supplement those on information. Additionally, trade union health and safety representatives have rights to information in the employers' possession (and employers have obligations (to provide it) to enable them to carry out their representative functions. Under Regulation 7 (2) of the Safety Representatives and Safety Committees Regulations, the information includes: 'Information of a technical nature about hazards to health and safety and precautions deemed necessary to eliminate or minimise them in respect of.. . substances in use at work, including any relevant information provided by . . . .the manufacturer, importer or supplier of any article or substance used or proposed to be used at work by their employees'. Section 6 of the HSW Act and Regulation 6 of the CHIP Regulations define what information suppliers are required to provide in the suppliers' safety data sheets

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that represent the form in which the most detailed information on safe use of substances is likely to reach workplaces. The data sheets should describe the hazardous properties of the substances, how they should be handled, stored and disposed of safely as well as describe procedures in the event of an accident or a fire, hi addition information on hazards is required on the labels of containers of chemical substances and as we discussed previously, the CHIP (Amendment) Regulations 1997 detailed requirements on the classification of substances, symbols to indicate hazards and requirements on using risk phrases selected on the basis of physiochemical properties, health and environmental effects. Despite the quite detailed legislative requirements on provision of information, in practice they were often not met and only rarely enforced (Hudspith and Hay 1998). Problems occurred at the interface between the supplier and the workplace and within workplaces between employers and workers and their representatives. Research evidence showed that although suppliers' information was probably the major source of employers' knowledge on chemical risk management, this knowledge was quite weak, especially amongst employers in smaller enterprises and that in relation to OELs it was severely limited. Surveys of the contents of safety data sheets indicated that while there had been improvements over time they rarely delivered information that was useful to users and enabled dutyholders to carry out a suitable and sufficient risk assessment. As Hudspith and Hay suggested: 'Primary producers of chemicals produce comprehensive information for their safety data sheets but many have little idea about the end use of the chemicals they supply. Advice on control procedures is even more limited by the fact that most data sheets are now generated electronically, according to a standard formula. This means that most sections that deal with control procedures simply reproduce stock phrases on safety and risk. Further down the supply chain products are put to more specific uses. This ought to prompt some changes in advice about control procedures. In practice however, there is often no change in the advice proffered. At the end of the supply chain, control advice should be specific and suppliers ought to know more precisely how their products are to be used. Regrettably many suppliers do not know.' Of course, even if the information was of a suitable and sufficient quality this did not mean that employers would use it appropriately or that they made it available to their workers and their representatives. There is, for example, a considerable

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body of research on the role of health and safety representatives that shows that while good information is one prerequisite for their successful engagement in improving health and safety arrangements and outcomes at the workplace, it is an area in which representatives have frequently complained they have problems in their relations with employers and managers.'91 Overall then, while information requirements under health and safety law to facilitate the safe use of hazardous substances were considerable, there was good circumstantial reasons to suppose that neither employers nor their workers were making the best use of such information following the implementation of the COSHH Regulations.192 It seems particularly unlikely that under such circumstances there would be widespread understanding of the significance attributed to the role of OELs in the principles of occupational hygiene central to the proper operation of risk management under COSHH. Therefore it was also unlikely that OELs would have been used in this way by anything like the Ml range of users of hazardous chemicals in the UK. The role of OELs in enforcement actions. Compliance with OELs is a legal requirement under the COSHH Regulations. Under the HSW Act 1974 HSE inspectors have powers to institute a range of formal enforcement actions. These include two types of enforcement notice - an improvement notice or a prohibition notice - as well as powers to institute prosecution for criminal offences in the Nevertheless as the research reported in the next section shows, trade union health and safety representatives surveyed in the study commissioned by the HSE (Research International 1997) were considerably better informed about OELs than were employers. The explanation the researchers offered for this finding was that the safety representatives in their survey were mostly drawn from larger enterprises. A further factor would have been the extent of health and safety training received by the representatives — which is considerably greater than that received by the average small enterprise owner manager and which deals specifically with representing workers that use hazardous substances. It is interesting to note in this context however that amongst UK respondents to the European Foundation's Third Survey of Working conditions were the highest proportion of those who felt themselves to be very well informed about the risks resulting from the use of materials, instruments or products they handled in their jobs (52.8 per cent compared with an EU average of 40.2 per cent) (European Foundation 2001). This contrasts with the more detailed evidence from the UK studies reported here which suggests that whatever the respondents to the Foundation's survey may feel, the provision and understanding of information on chemical hazards in British workplaces is generally poor.

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courts. Improvement notices are normally used to instruct duty holders to remedy a situation in which an inspector believes that there has been a breach of the law resulting in a risk to the health or safety of persons the law is intended to protect. The duty-holder is normally required to remedy the situation within a specified time period in accordance with the requirements laid out in the notice. Prohibition notices are normally issued where inspectors feel there is an imminent and serious risk to health and safety. They have the effect of prohibiting the continuation of the activity that is the cause of the risk as well as requiring it to be corrected in accordance with requirements identified in the notice. Not surprisingly, because of its power to stop work processes, the prohibition notice is generally regarded as the more serious of the two forms of enforcement action. However, failure to comply with either notice is a criminal offence that may result in prosecution. All these kinds of formal enforcement actions were possible actions for HSE inspectors seeking compliance from duty holders in relation to the COSHH Regulations. An indication of the role of enforcement in improving risk management of hazardous substances should be given by examination of records of the extent and nature of enforcement actions involving OELs that have been taken under the Regulations. This is theoretically possible because the Statistics Unit of the HSE records overall figures for enforcement actions by HSE on all aspects of health and safety. In addition HSE has an operational database (FOCUS) that provides further detail on the nature of enforcement notices and prosecutions, including a record of the Regulations under which they have been issued and notes on them filed by the inspector involved. Although not undertaken until sometime after the introduction of a changed role for OELs towards the end of the 1990s, HSE's own analysis of its enforcement record showed that despite their centrality to monitoring and control under COSHH, OELs played only a minor role in the enforcement of the Regulations. The HSE study was actually undertaken as part of the background information HSE produced to inform the Discussion Document on the OEL Framework (HSC 2002a). Nevertheless it analysed records of formal enforcement actions under the COSHH Regulations undertaken by the Field Operations Directorate (FOD) and the Hazardous Installations Directorate (HID),1'1 from the first full year in which

The two main units within the HSE inspectorate that were likely to have undertaken enforcement on chemical hazards. Although other HSE operational arms such as the Nuclear Inspectorate were not included in the study, its author believed such enforcement

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they were in force (1990/91) and looked in more detail at the enforcement figures for 1997-2000. The aim of the study was to analyse the extent and type of enforcement action taken to control exposure to substances hazardous to health and in particular to evaluate the role of OELs in them. Its results do not present a comprehensive analysis of all forms of enforcement action in relation to managing chemical hazards, they nevertheless provide an indicative picture of the extent to which OELs featured in such actions."4 The analysis also identified the number of 'contacts' that mentioned COSHH recorded on the operational data base between 1997 and 2000. 'Contacts' is a generic term including all kinds of inspectorate field activities, from simple informative ones that might, for example, include providing a leaflet on COSHH during a general inspection to major investigations and prosecutions. An average of over 10,000 per year of contacts was found, suggesting that the general level of inspectorate activity involving COSHH was quite high during the 1990s.19* But such information tells us nothing about the nature of the action involved. Only a small proportion (between 1-3 per cent) of prosecutions taken during the period concerned COSHH. Between April 1996 and March 1999, there were 47 prosecutions covering a wide range of hazardous substances. The largest group were substances with OELs (over 50 pert cent of the total). However, less than half of the prosecutions mentioning these substances appeared to have concerned situations in which exposure by inhalation was the problem. Of the ones that did, the majority (13) involved incidents in which exposure was very much in excess of the OEL - generally resulting in serious (often fatal) acute effects. The author of the HSE research concluded that these cases represented situations in which

actions that may have been missed as a result were negligible in number compared with those undertaken by FOD and HID. As its author points out, although the COSHH Regulations are specifically concerned with chemical hazards, they are not the only Regulations under which an inspector might lake an enforcement action in relation to processes involving chemicals. For example it is likely that some of the situations addressed under the Management of Health and Safety at Work Regulations and the Workplace (Health Safety and Welfare) Regulations would also involve remedying health and safety management defects in relation to chemical risks. Indeed, the researcher's further interrogation of the database in relation to two common workplace substances 'indicated that the true number of COSHH contacts could be up to four times this figure*.

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catastrophic loss of control had occurred and the type of limit had not been relevant in influencing the decision to prosecute. The data on enforcement notices was considerably more extensive and demonstrated several features of the role of OELs in regulatory intervention. They confirmed that regulatory action under COSHH was a significant activity for inspectors during the period of the review, accounting for between 12-21 per cent of all enforcement notices issued.196 As would be expected from the pattern of notices served generally, the majority of COSHH notices were improvement notices. There had been a decline in the number of notices issued annually during the 1990s. There had also been a shift in the proportion of notices issued under different Regulations with an decline in those issued under Regulation 6 on risk assessment and an increase in those issued under Regulation 7 on control and under Regulation 9 on maintenance of control measures. Prohibition notices had increased in overall numbers and in relation to their proportion in comparison with improvement notices. The explanation for the fall in absolute numbers of notices issued and changes in the proportions of notices issued under different Regulations was largely thought to reflect changes in FOD inspection policy priorities during the period. In the early 1990s, while the Regulations were still new, such policy focussed on risk assessments. As many employers had not yet undertaken them and issuing a notice to deal with this breach was a relatively straightforward matter, significant numbers were issued. At the time there was also considerable publicity given to the need for 'COSHH Assessments'. As time passed, there was a change in FOD policy with greater emphasis placed on control measures and their maintenance. The overall number of improvement notices issued under Regulation 6 declined significantly as a result.197 While there was a proportionate rise in the number of In 1990/91 a total of 2,518 improvement notices were issued under COSHH. Their annual number declined gradually during the 1990s to 1007 in 1999/00. In 1990/91 there were 136 prohibition notices issued. The numbers issued over the next ten years fluctuated between 80 to 150 per year until 1996/97, but increased significantly after this time, reaching 278 by 1999/00. A contributory reason for the decline after 1993 may have been the introduction of the MHSW Regulations 1992, which required risk assessment and some notices for failure to undertake risk assessment in relation to hazardous substances may have been served under Regulation 3 of these Regulations. A further influence on the overall decline of notices served under COSHH was also likely to be the decline in the numbers of notices issued on

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notices issued under the Regulations dealing with control and its maintenance, their numbers did not entirely compensate for the fall in risk assessment notices. An additional factor in the decline of improvement notices in the mid-1990s was the introduction of requirements on inspectors to issue a notice of intent before an improvement notice was issued. This may have had the effect of obviating the need to issue an improvement notice in some cases since duty-holders would have made the necessary improvements under the notice of intent. This requirement was removed in 1997. A further influence on the decline of notices served under COSHH would have been the decline in the overall numbers of notices issued on all aspects of occupational health and safety. This was a reflection of the reduced resourcing for health and safety regulation and a general deregulatory drive that was Conservative Government policy during the 1990s (James and Walters 1998). However, the HSE research shows in its analysis that in fact improvement notices issued under COSHH maintained their profile of between 22-30 per cent of health and safety notices overall during this period. Paradoxically they declined in significance following the increase in general inspection activity that occurred from 1998 after the election of the Labour Government in 1997. Although in comparison with improvement notices the number of prohibition notices issued under COSHH was relatively small, they increased in overall number during the 1990s and also therefore in proportion to improvement notices. The explanation for this is most likely to be the planned inspection activities of the FOD in particular industry sectors. Here, clear guidance would have been provided to inspectors on control standards and level of enforcement required, thus increasing their confidence to take this more serious enforcement action in circumstances in which it was felt to be warranted. The detailed examination of the subject matter of enforcement notices issued between 1997 and 2000 looked at both the substances and processes that had been all aspects of occupational health and safety. This was part of the deregulatory drive and reduced resourcing for health and safety regulations that was Conservative Government policy during the 1990s (James and Walters 1998). It included instruction to inspectors to issue a notice of intent before an improvement notice was issued — this may have obviated the need to issue an improvement notice since duty-holders would have made the necessary improvements under the notice of intent. However, this requirement was removed in 1997.

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of concern. It showed that substances with MELs dominated those that had featured in these regulatory interventions but at the same time there was considerable amount of COSHH enforcement activity in which it was the process involved that was the focus of enforcement rather than specific substances. However, even here, it was substances with MELs that were usually central to these processes. The two processes that featured most often in enforcement actions were sheep dipping and cement handling. Neither are particularly relevant to our interest in the role of OELs because cement handling essentially concerns dermatitis risks and in sheep dipping there was only one substance with an OEL198 and again the greatest concern there was with skin absorption. Their frequency in the enforcement statistics however, is further evidence of how COSHH enforcement was driven in relation to planning objectives since both had the subjects of planned enforcement campaigns during the period. In terms of understanding the position of OELs in relation to COSHH enforcement, the detailed analysis of substances and processes referred to in notices drew several conclusions. It showed that enforcement of control issues under Regulation 7 depended on evidence of the general inadequacy of control rather than on specific evidence of non-compliance with OELs. However, the existence of an OEL for a substance meant that the substance was likely to become a focus of attention by the enforcing authorities even if inspectors did not often concern themselves specifically and directly with OELs in individual workplaces. The HSE study argued that these observations suggested a probable explanatory mechanism of action as shown in Figure 4.3 and it would be anticipated that this mechanism would be stronger when the OEL was a MEL.

Diazonin

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Figure 4.3 Mechanism of actions involving OELs

OEL established

HSE and industry examine what is required to achieve compliance

i r

Good practice guidance is published

Inspectors enforce adequate control under COSHH that is based on this guidance

The role of the type of OEL in influencing enforcement on control. The HSE research suggested that the confidence of inspectors that they were enforcing appropriately was an important factor in determining whether they took action. For example, an additional reason that helps to explain the high frequency of sheep dipping and cement handling in COSHH enforcement actions is that as well as being the subject of planned enforcement, they were both situations in which relatively straightforward effective and inexpensive control measures could be implemented and therefore ones in which inspectors would be confident about taking actions to insist on such measures. Planned enforcement campaigns also provided inspectors with much clearer guidance both on the level and type of enforcement required and on the technical issues in relation to control. In routine inspections on more complex situations inspectors would be likely to be less confident. While it might be anticipated that this would mean that in such situations they would resort to establishing whether OELs were being exceeded, perhaps by calling upon specialist assistance to determine this and to advise on

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appropriate control, the HSE analysis of enforcement did not show this. Rather, the author of the research report argued, it demonstrated that in fact what was more likely to happen in such complex situations was that instead of taking action under Regulation 7 on control, the inspectors would be more inclined to take enforcement action under Regulation 6 on risk assessment, which was simpler.1" Employers' understanding, competence and use of OELs. The most significant issue concerning the role of OELs to emerge during this period was the extent to which they really featured in employers' strategies for managing the risks of hazardous substances under the COSHH Regulations, hi 1997, HSE published a commissioned market research study that measured perceptions and understanding of OELs amongst employers and to what extent they were useful and influenced industry in controlling exposure to hazardous airborne substances (Research International, 1997). The study population had been drawn from both light and heavy users of chemicals across a range of establishment size from less than ten employees to more than 200. A representative sample of managers responsible for health and safety in these establishments were interviewed by telephone. The results demonstrated that there was real cause for concern over the understanding and use of OELs by all users of chemicals and that, not surprisingly, the level of understanding and appropriate use of OELs was related to establishment size, and increased as size increased. The results of the survey suggested that most chemical users were taking some steps to control the risks of chemicals they used, in keeping with findings of previous research (OHR 1993). However they also showed that in doing so, little regard was paid to either information from the HSE or the core messages of the COSHH regulations concerning the preferred hierarchy of such control. Notions of substitution of hazardous substances for safer ones were rarely considered and the use of personal protective equipment was advocated by users with at least as much frequency as the preferred methods detailed in COSHH such as control at source through process modification or ventilation systems. The survey demonstrated that most users of chemicals relied on suppliers and on their personal experience for information on chemicals, with relatively few using sources such as the HSE. Most respondents indicated that their assessment of risks was based on 'common sense judgement' about the health effects of substances and how they are used at 199

It might also imply of course that inspectors did not have sufficient access to such resources for technical advice and support.

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work. Concentrations of substances in workplace air were scarcely mentioned in this respect. Real knowledge of OELs was shown to be extremely low and very few respondents knew anything of the different types of limits defined by OES and MELs. Nearly half of the respondents did not know how they would go about finding out if an OEL was being met in their workplace. The survey showed clearly that OELs played very little part in either risk assessment or risk management in small and medium sized enterprises. Commenting on the survey's findings in a subsequent paper, policy staff from the Health Directorate of the HSE (Topping200 et al 1998) suggested that it raised important questions concerning the value of continuing to attempt to generate ever-increasing lists of OELs - already viewed by some as a somewhat Sisyphean task.201 Instead they argued that the survey's demonstration of the very low understanding and use of OELs called for a reappraisal of the system. They noted that although OELs were originally developed as technical standards against which to monitor the adequacy of controls - and large chemical firms may indeed have continued to use them effectively in this way - it was quite clear that most chemical users (including many heavy users) did not. They suggested that in the light of this evidence of poor understanding and limited use, it would be appropriate to consider the development of the role of OELs in more useful directions, arguing that they could also be utilised in other ways - such as, for example, in identifying appropriate control measures for users of chemicals without detracting from their original role. At the same time they suggested that the low awareness of OELs among most chemical users meant it was sensible in future to restrict the list of OELs to widely used substances where their toxicity was of concern.

Michael Topping was chairperson of ACTS. As Topping et al pointed out, there were well over 100,000 substances in use in Europe and only around 600 had OELs in the UK. A mere 10-20 were added or revised each year, meaning that setting limits for anything like the number of chemical substances in regular use was widely perceived to be impossible.

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NEW APPROACHES TO CHEMICAL CONTROLS: A NEW ROLE FOR OELS? A new policy perspective on regulating the management of chemical hazards was beginning to emerge in the UK at the end of the 1990s, in which it was recognised that employers generally and especially those in smaller enterprises were unlikely to have the capacity to utilise the occupational hygiene approaches required by COSHH to control risks of the hazardous substances they used. There were two major points of departure for policy makers in relation to a continued role for OELs in the UK. One advocated an approach in which OELs would be utilised in identifying appropriate control measures that could be recommended to users of chemicals in addition to their traditional functions standards for checking the control of risks. The other called for a pragmatic recognition that it was entirely unrealistic to pursue policy based on the notion that all toxic substances likely to pollute the air of British workplaces could be given an OEL that would be understood and used appropriately.202 The paper by Topping et al referred to earlier was an introduction to this new approach from the HSE. The issue of the Annals of Occupational Hygiene in which it appeared in 1998 was devoted to the role of OELs in the risk management of hazardous substances. The three papers that followed it in the same issue, were all written by members of the HSE Health Policy directorate and its occupational hygiene support staff. In combination they introduced a scheme for helping small firms control chemical risks and outlined the hygiene and toxicological thinking behind it (Russell et al 1998; Maidment 1998; Brooke 1998). The papers presented an approach developed by HSE specialists in conjunction with a working party set up by ACTS, on which the interests of trade unions and

This was the pragmatic view of reality under the UK health and safety system, in which expert occupational hygiene advice was restricted to discretionary use by a diminishing number of large employers that were significant users of hazardous substances. Commentators on the suggested policy implications by Topping et al, pointed out that the UK was virtually the only country in Europe that did not have any statutory requirements on the quality and use of prevention services. Such suggestions for policy s might be less persuasive under arrangements that required employers to make use of qualified expertise (Ogden 1998).

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employers had been represented as well as that of independent expertise. They began by acknowledging that the research findings on the level of understanding and use of OELs by most employers showed that such limits played only a minor role in controlling chemical risks in the majority of workplaces and especially in smaller workplaces. They contended that if employers in these smaller enterprises did not have the capacity to use OELs in the way intended, other ways of utilising information and approaches to managing the risks of hazardous substances that were within their capacities to access and understand needed to be found. In particular the approach they wished to advocate built on the observation in the original research reported by Topping et al - that the single most used source of information by employers in SMEs was that provided by suppliers. Therefore they proposed an approach in which this information - and particularly the R-phrases used on suppliers' safety data sheets and on labels required under CHIP - could be utilised to better effect in establishing generic and accessible control criteria.203 In this way, in most cases the need for detailed understanding and use of OELs would be obviated. This was not an entirely new concept in occupational hygiene circles. Since the early 1990s the scientific literature had contained a detailed discussion of some of the ideas that underpinned the HSE proposals. For example, several methods for grouping substances into different risk categories of seriousness (exposure banding) and developing appropriate controls for their use that could be applied generically across such groups (control banding) had been the subject of analysis and comment in previous years, hi addition some industry associations and professional bodies had produced their own guidance to the COSHH requirements based on a similar conceptualisation.204 The significance of the scheme proposed by the HSE was that it was not only building on these earlier industry approaches to setting in-house limits but also The further advantage they identified in using such R-phrases was that they were based on the classification system required at EU level and would in time be harmonised across the whole of the EU member states. These approaches had been outlined for example in relation to aromatic amines and related compounds (Money 1992); for pharmaceutically active substances (Nauman et al 1996) for volatile organic substances (Gardner and Oldershaw 1991) and for laboratory chemicals (Royal Society of Chemistry 1996), on occupational exposure bands for colourants (CIA 1993) and subsequently by the Chemical Industries Association in guidance to its members covering a wider range of hazardous substances (CIA 1997; Guest 1998).

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that it was particularly geared to the needs of SMEs. Consequently, it emphasised accessibility and ease of understanding as well as use of hazard information that was most readily available. Rather than setting in-house limits or control bands its objective was to provide clear advice on good practice in relation to appropriate controls and their selection. A simple system of generic assessment based on readily available suppliers' hazard information (R phrases etc) combined with likely use scenarios was outlined. It was argued that it was possible to determine a range of adequate control strategies and advice based on analogy with substances with similar hazardous properties to which OELs were already assigned. In essence therefore, the model represented a process in which hazards and exposure potential (based on the extent of their likely-use) could be grouped in various combinations that would generate appropriate control measures. The R-phrases defined under the CHIP Regulations were grouped into five bands covering the range of seriousness of health effects resulting from inhalation (and a sixth covering skin and eye contact). Each band signified a different level of seriousness of health effect - and therefore different level of control measure required. Although the scheme was not entirely comprehensive - it could not cover substances outside the scope of CHIP such as pesticides and Pharmaceuticals for example, it was nevertheless sufficiently wide ranging in its coverage to be thought to be a useful improvement on existing approaches.205 Having established a means of grouping potential health hazards of substances, the second element of the scheme was to establish similar system for grouping potential exposure - that is - how much of the substance was likely to be in the breathing zone of workers. Two factors were thought to broadly determine this: the physical properties of substances (their dustiness or volatility) and the amount in use. Simple definitions of physical properties and usage were therefore proposed (high, medium or low dustiness and volatility and usage of small, medium or large amounts of substances (by weight or volume)).

It was also recognised that the scheme could not apply to process generated hazards such as fume and wood dust for example nor did it fully take into account the duration of exposure in its predictive approach to exposure potential. Its control strategies therefore were most relevant to shorter-term exposures. Commentary on the occupational hygiene aspects of the model recognised that little was known of the actual exposure of workers in small enterprises and it was possible that actual exposures may in some cases be of longer duration than originally thought (Maidment 1998).

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These generic approaches to health hazards and potential exposure were matched by equally generic approaches to exposure utilising three basic control methods general ventilation, engineering control, containment and a fourth approach that signalled that special controls needing expert advice were required - to help achieve levels of exposure in line with the exposure ranges deemed to be acceptable risks for the previously identified hazard bands A-D.206 The scheme would be operationalised through the provision of simple, good practice advice on the form of controls applied to particular operations through a series of operationbased guidance sheets. Access to these guidance sheets was to be supported by exploiting existing information routes used by owner managers of SMEs such as suppliers, trade associations, trade union representatives and OHS professionals. The basic scheme was presented as simple step-by-step guidance with checklists to guide the reader through the process of assessment necessary to identify the appropriate control for the substance in question and a means of identifying the appropriate control guidance sheet for whatever operation the user required. Each control guidance sheet was intended to provide users with sufficient information to check the adequacy of existing control measures or to install appropriate new controls. They were written in a jargon free style covering basic information on setting up specific controls and good operational practice and supporting advice on personal protective equipment, training needs, maintenance examination and testing. The HSE proponents of the scheme argued that OELs were fundamental to the technical basis for its existence. They maintained that following its guidance would result in controls being put in place that would achieve compliance with OELs for substances in work place air, where OELs existed for such substances. The papers that detailed the scientific reasoning and experimentation behind the scheme's development went to some lengths to describe the extent to which its approach built upon the existing role of OELs and had been evaluated against toxicological and occupational hygiene considerations of the same order as those employed in setting OELs (Brooke 1998; Maidment 1998). Brooke (1998) showed how the use of R-phrases as the basis for the identification of appropriate The fifth band, E, included substances that present the most serious health risks such as carcinogens and signalled very tight control and specialist advice, and the sixth related to skin and eye contact for which separate measures of control were to be proposed.

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control strategies in the scheme led to recommendations for controls that were equivalent to or more stringent than that required by the health based OEL for 98 per cent of substances tested that possessed them. For the two substances where the scheme would have resulted in a level of control lower than that indicated by their OELs, in both cases the results could be explained by anomalies in the information on the OEL and it was argued that even for these substance the controls that would be set under the scheme would in practice be adequate. In addition it was maintained that the scheme was aimed at small firms in which there was little chance of OELs being used appropriately. Therefore it did not in any way serve to undermine the role of OELs in determining the adequacy of workplace controls in establishments in which there was dedicated health and safety expertise to do so. Nevertheless, there seems little doubt in hindsight that these developments were important milestones in the changing conceptualisation of the role of OELs in what was seen to be the achievement of pragmatic and practicable approaches to risk management of for all users of hazardous substances in the UK. In essence the proponents of the scheme were suggesting that its pragmatic approach recognised the realities of work in small enterprise and offered practicable strategies for risk assessment and control of hazardous substances in these premises. They maintained that such strategies were in keeping with the legislative principles of risk assessment and control under the HSW Act and the COSHH Regulations. However they achieved their ends without requiring duty holders to have recourse to the little understood technical basis for such control that was required to implement the monitoring, evaluation and control principles of occupational hygiene that were part of the original conceptualisation of COSHH and in which OELs played a direct role in the workplace. Instead, in the new approach, OELs while still fundamental, were returned to their more appropriate position in the domain of the expert. Secondly, this revised role for OELs as part of the specification process for control strategies, in combination with the acknowledgment of the evidence of their poor understanding by users generally, and the large number of chemical substances on the market, was also a reason for arguing that setting more OELs were not necessarily the most effective way forward. Rather, it was suggested that it would be more appropriate to restrict the list of OELs to widely used substances of concern (Topping et al 1998). As Ogden (1998) speculated with the title to his editorial in the issue of the Annals of Occupational Hygiene in which these proposals first appeared, they

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seemed to suggest the 'Sunset of Exposure Limits. . . .' but as he pointed out in the editorial itself, whether they were to represent the '. . Dawn of Something Better?' would remain to be seen. In a subsequent editorial in the same journal some two years later he further pointed out that the real test of the proposals would be research evidence on the extent and success if their use (Ogden 2000).

OELS AND C O S H H ESSENTALS IN PRACTICE In the last five years two related themes have been pursued in regulatory policy on chemical risk management in the UK. Both have antecedents in the developments discussed in the previous two sections. First, there has been the continued evolution of the regulatory position of OELs, in the course of which public consultation has taken place concerning a new Framework for OELs that was finally agreed in 2004. Second, implementation of the strategy for regulating the management of the risks of hazardous substances described in the previous section has taken place with a much publicised rolling out of the HSE scheme known as COSHH Essentials. This scheme, based on the ideas discussed in the previous section was intended to provide a practicable approach to achieving improved risk management across the full range of users of chemicals at the work and not just those in a position to utilise appropriate expertise. In this section we look at the inter-relationship between these two parallel developments as well as the other factors that have influenced the thinking behind the British position in relation to the current and future role of OELs in improving the work environment. COSHH Essentials. The HSE COSHH Essentials scheme provided guidance to chemical users - especially those in small and medium sized firms - through making available materials as aids to risk assessment and control along the lines described in the previous section. It was a simple, checklist based risk assessment that led the user to a control approach deemed suitable for their chemicals or tasks through users entering information about the chemicals they used onto a checklist. As noted previously the information required concerned the hazard group to which substances belonged - the 6 groups described previously (A-E and group S for substances causing harm through skin contact), based on the Risk Phrases for chemicals that

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should be identified on the suppliers' data sheet. The amount used (small, medium, large) was noted as was the physical properties in terms of dustiness for solids and volatility for liquids. A table then directed the user to one of four generic control approaches: i. general ventilation ii. engineering control iii. containment iv. when very hazardous chemicals and risky tasks were identified, the guidance directed users to seek specialist advice. The guidance included practical advice on using the approaches to control and on how to obtain specialist help. There were 60 illustrated control guidance sheets giving good practice advice for common tasks such as weighing, mixing and sieving chemical substances and additional sheets on avoiding skin and eye contact and on protective equipment. In 2001 the HSE commissioned a survey of the use of COSHH Essentials amongst the small and medium sized companies (with fewer that 249 employees) that had purchased it (Wiseman and Gilbert 2002). The sample showed a marked bias towards firms in manufacturing and although it and COSHH Essentials were aimed at SMEs, it was the larger of these firms that predominated amongst the purchasers and users of the guidance. Of the 500 firms in the survey approximately three fifths had taken some action since purchasing the pack and the majority of these thought they now knew how to do risk assessments, were confident of their risk assessments and thought they now knew how to control chemical health risks at the workplace. Although COSHH Essentials was initially introduced as a paper system an interactive electronic version soon followed using the same checklist based approach. Uptake of this version is monitored and recent results available from HSE indicate that its site has received a substantial number of visits since its launch (over 400,000 visits made by over 170,000 visitors and with over 165,000 COSHH Assessments completed by September 2004). While these limited findings indicate something of the uptake and opinions of users of COSHH Essentials about their use they unable to provide objective information concerning the nature of use and they are therefore of little help in evaluating the effectiveness of the guidance in comparison with other approaches

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to risk assessment and control of chemical hazards in which OELs might feature more centrally. Nor are they particularly helpful in measuring the scale of use. OELs for the new millennium? The emerging understanding of the limitations to the role of OELs and their place in occupational hygiene 'best practice' in chemical risk management for the majority of users was a problematic issue for the strategic approach to regulating chemical risk management. Coupled with the technical, scientific, legal and economic problems associated with the setting and meaning of OELs, it was enough to give regulatory policy makers pause for thought over the appropriateness of the existing system. If such concerns were not sufficient, there were further problems caused by the compatibility of the UK system with the requirements of EU Directives. In particular the British system was out of step with that required by the Chemical Agents Directive, in which member states were obliged to set limits at levels taking into account those in the IOELV Directives. In 2002 a Discussion Document was published in which views were sought on a set of proposals for a revised UK Framework for OELs. Essentially they identified a set of seven key objectives for OELs. They were: 1. OELs should control risks to health — They should provide standards that could be used along with other information to decide on appropriate control measures and to assess the adequacy of measures in place 2. OELs should be readily understood and accessible — The OEL framework should be based on a clear and coherent set of concepts that employers and employees understand, but application at the workplace needs professional input 3. OELs should be legally enforceable - They should provide legally enforceable standards for the adequacy of control by inhalation and they are for use when prevention of exposure is not reasonably practicable 4. OELs should be comprehensive — The OEL Framework must be comprehensive and capable of application to all substances. It should be capable of application to generic groups of substances. The Framework must be developed and presented in such a way that it will not encourage employers to use substances without OELs that are not adequately evaluated 5. OELs should comply with EC legislation

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6. OELs should be flexible and able to take on board new developments in science and technology 7, OELs should provide incentives to reduce exposures. Three models were proposed in which a modified UK system might provide a framework within which these objectives for OELs might be achieved. One involved minor tinkering with the existing system - an option that the Discussion Document indicated would not solve the problems it identified. The remaining two proposals required somewhat more radical change. They outlined a system of exposure limits that were linked to regulatory requirements concerning good practice. The second proposal was based around a system of single limits while the third retained a dual-limit system but proposed similar links to good practice as the second. For substances with exposure limits both proposals recommended that the definition of 'adequate control' in Regulation 7 of the COSHH Regulations should consist of two components that employers must operate together to 'apply the principles of good occupational hygiene practice; and comply with the limit value*. Compliance under the new definition would mean: 'The good practice requirement would represent what a good employer does to ensure that exposure to a substance with an exposure limit is not exceeded'. These principles of good practice were to be amplified in guidance for particular substance-task combinations. As a default the COSHH Essentials approach was to be specified - making use of the HSE's work relating exposures to different levels of control specified under COSHH Essentials. All but two of the respondents to the Discussion Document207 were supportive of one or other of these two proposals. HSE concluded from its analysis of responses and of additional views received during its efforts to disseminate and discuss material on these issues that there was overwhelming support for a single limit system that was coupled to good advice on controlling chemicals (HSC 2003:9).

There were 58 responses received. According to the HSE's analysis only two did not support either the second or third proposal (HSC 2003). See also http://www.hse.gov.iik/aboutus/hsc/iacs/211102Zpaper43.pdf for the full analysis of the responses to the Discussion Document.

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Based on these conclusions a Consultation Document was published that made proposals to introduce a new OEL Framework (HSC 2003) that was a combination of the second and third options described in the Discussion Document. It reiterated the belief that many employers, particularly in small firms, did not know about OELs and of those that did, very few understood how to work out whether the chemicals in the air at their workplaces were above or below the relevant OELs. Because of this and other work on small firms it argued that a new approach was necessary. It advocated the replacement of the two types of OELs that had been in use since the mid-1980s (the OES and MEL) with a single type of OEL to be known as a workplace exposure limit (WEL). Employers would be required to ensure that the amount of chemical in workplace air did not exceed the WEL. However, since it was recognised that only for very few chemicals was there sufficient information to be able to say with certainty that harm would not occur to anyone exposed at the WEL, it was not possible to regard them as 'safe limits'. Since it was essential that such uncertainties be accounted for in any system that aimed to protect workers properly a new COSHH Regulation 7 (7) replaced the COSH 2002 Reg. & (7) and 7 (8). It stated: 7 (7)

Without prejudice to the generality of paragraph (1) , where there is exposure to a substance hazardous to health, control of that exposure shall only be treated as adequate if(1)

(2) (3)

the principles of good practice for the control of exposure to substances hazardous to health set out in Schedule 2 A208 are applied;^ any workplace exposure limit approved for that substance is not exceeded for a substance which carries the risk phrase R45, R46 or R49209 or for a substance or process which is listed in Schedule 1, the level of exposure is reduced so far as is reasonably practicable.

These are the 'principles of good occupational hygiene practice' previously referred to which were now to be introduced as a schedule to the Regulations (and therefore have the force of law). R45 — substances that may cause cancer. R46 —substances that may cause heritable genetic damage. R49 — substances that may cause cancer by inhalation.

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A key feature of the new proposals therefore was to link principles of good practice with compliance with the WEL. In so doing the proposed regulations would require employers to both apply principles of good practice and not exceed the WEL. hi addition specific requirements to reduce the amounts of carcinogens in workplace air to as low as is reasonably practicable (ALARP) were to be specified. To deal with the issue of employers' understanding, the consultative document proposed: - ' For each substance that has a WEL, HSE will produce practical advice that will tell employers what they have to do to control for their use of the chemical. For chemicals that can cause cancer HSE's advice will explain what ALARP means in practice. Thus employers will not simply be left with a number, as in the present OEL system but will have information on what they have to do to comply with the law'. The practical advice that it proposed would 'link together information on WELs, COSHH Essentials - which gives practical advice - and more in depth information on individual chemicals and the COSHH Regulations'. However, the consultative document also suggested that the existing list of over 500 OELs contained many for which the evidence on which they had been set was no longer considered reliable. Initially it was proposed that only existing OELs that were considered to be scientifically robust would be transferred to the new system of WELs. HSE estimated that this would reduce the list of substances with regulatory OELs to around 150. This proposal was greeted with consternation by respondents to the Consultative Document, and especially by the representatives of the occupational hygiene practitioner community who viewed many of the original OESs as useful standards, even if they were adopted from earlier TLV lists in which the evidence on which they had been set was incomplete by current standards.210

Indeed such concern was recognised by ACTS and the HSC and the final version of the new OEL Framework modified this proposal to that of withdrawing only those OESs for which there was concern that about whether human health is protected at the level of the OES. This in effect meant that only 100 of the 322 OESs that were not transferable under the original proposals, would not be transferred into the new system as WELs.

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New WELs would be set according to a new set of criteria that would: -

allow WELs to be set for any substance of concern and enable Indicative Occupational Exposure limit Values (IOELVs) and Binding Occupational Exposure Limit Values (BOELVs) to be implemented as WELs without lengthy debate as to whether they should be implemented as OESs or MELs.

The WEL setting process was summarised in the diagram reproduced in Fig 4.4. It was acknowledged in the Consultative Document, that although it was possible to identify a 'threshold' of effect for some substances in the context of OEL setting, for others it was not. Therefore the concepts of No Observed Adverse Effect Level (the highest point on the exposure response curve at which no adverse health effects are observed - NOAEL) and Lowest Observed Adverse Effect Level (the lowest point on the exposure-response curve at which adverse effects are observed- LOAEL) only have practical relevance for OEL setting for those substances or toxicological mechanisms that have a threshold effect. For others such as DNA reactive chemicals that cause cancer by a genotoxic mechanism, although in theory a threshold may exist, currently available techniques do not allow reliable identification of the NOAEL. Additionally there are further substances, such as those that cause asthma for example, or mixtures of substances of variable compositions such as found in metal fumes for which it is not possible to define a single NOAEL for human health. Moreover the balance of doubt and uncertainty about likely human health effects for substances for which toxicological data is inadequate means that a threshold of effect cannot be predicted with any certainty for substances for which such data is incomplete. Finally, even when such a threshold can be confidently predicted there are some substances for which the costs involved in its achievement mean that it is not reasonably practicable to set an OEL at the level that would result in no adverse human health effects. For all such substances therefore the Consultative Document makes it clear that the WEL would be derived by identifying a level of exposure that would represent a standard of control that was commensurate with good occupational hygiene practice and as far as possible would not be set at a level at which there was positive evidence of adverse effects on human health. Although many of these caveats concerning the limits of toxicological understanding in relation to NOAELs and LOAELs and their application to OEL setting are familiar from previous approaches to setting OELs, the generally

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greater emphasis on explicitly distancing OELs from the idea that they could be taken as 'safe levels' - such as was exemplified in the frank acknowledgement of the limits of scientific knowledge that characterised the procedures outlined for setting limits - distinguished the approach taken in Consultative Document. Figure 4.4: Summary of WEL setting procedures (after HSC 2003)

Assessment of Toxicology Toxicology Assessment

Assessment of Occupational Occupational Assessment Exposure Exposure

Identify exposure exposure level at which which no Identify adverse health health effects effects would be expected expected adverse known and/or and/or to occur based based on the known predicted effects effects of the substances substances and predicted that is also reasonably reasonably practical practical to achieve achieve

possible, identify identify exposure exposure If this is not possible, level achievable achievable with good control taking into account account nature/severity nature/severity of health health hazards and costs/efficacy of control hazards costs/efficacy control solutions solutions

Recommend WEL at this level Recommend

SUMMARY OF WEL SETTING PROCEDURES (AFTER HSC 2003) On the need for monitoring to ensure compliance in the case of substances with OELs the Consultative Document indicated that the circumstances in which monitoring was required remained unchanged from those set out in the COSHH Regulations 2002. However it also made it clear that if employers were following good practice advice and ensuring controls were functioning correctly (for example by monitoring airflow into local exhaust ventilation) it may not be necessary to monitor for hazardous substances, since such good practice should have served to keep their concentrations below the relevant WELs. On the question of enforcement the Consultative Document referred to the current enforcement strategy of the HSE for health and safety issues generally. It drew attention to the HSC enforcement policy statement setting out the principles inspectors should apply when determining what enforcement action to take in

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response to breaches of statutory duty (HSC 2004). It went on to outline the HSE's Enforcement Management Model, developed by HSE to enable its inspectors to make enforcement decisions consistent with the Policy Statement. This approach was intended to operate by comparing the risk associated with a particular set of circumstances with a relevant benchmark to ascertain the 'risk gap' - that is, the level of residual risk once actions required by law were met. In the area of health risks both the principle of good practice for the control of substances hazardous to health and the existence of OELs were seen as critical in determining the relevant benchmark. If duty holders were applying the principles of good practice, then they should not exceed the relevant WEL. However, although WELs would be useful in determining benchmarks for certain substances and their breach indicate a substantial risk gap which by definition would anticipate some form of enforcement action, the Consultative Document also made clear: ' The increased emphasis on these principles of good practice for the control of substances hazardous to health reinforces the message that a judgement on the potential extent of exposure should take into account a variety of elements including: the condition of any control measure provided; the maintenance of any control measures provided; the provision of adequate instruction, training, and supervision and the consequences of limited health surveillance. The judgement is not necessarily dependent on measured exposure against limits.' (our italics) To understand the statements on enforcement in the Consultative Document they need to be viewed in the context of existing evidence on the role of OELs in inspectorate strategies seeking compliance with regulatory measures on risk management for hazardous substances. These in turn need to be understood within the context of evidence on the role of enforcement generally in health and safety in the UK. As we saw earlier, the evidence on enforcement practice gathered before the introduction of COSHH essentials and the consultation on the new OEL framework suggested that OELs did not normally feature directly in regulatory interventions to improve the management of chemical risks. Instead, their most significant influence was more indirect. The existence of an OEL and especially a MEL (signifying a serious risk to health) was most likely to act as a signal to regulatory inspection that attention should given to compliance with approaches to

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control. Since guidance on such approaches was increasingly likely to have been documented in the case of substances with MELs, regulatory inspectors could refer to them with reasonable confidence. MELs and guidance on control in processes in which substances with MELs are involved might also for the same reasons feature in planned inspections and sectoral inspection campaigns, themselves powerful determinants of quantitative trends in the nature of enforcement. Taken together all these factors would be likely to reduce the necessity of measurement to check compliance with OELs in the majority of cases as there would be other more obvious means of determining the extent to which processes complied with the relevant guidance. In situations in which this was not the case, but where substances with OELs were present, there may be good theoretical reasons for anticipating that inspectors might undertake, order or commission measurements, but enforcement statistics suggest that the resources and time involved in doing so were more likely to result in inspectors switching to a different focus for regulatory action and requiring simpler risk assessment measures from employers. In some cases this might demand that the duty holder organise monitoring and checking compliance with OELs but in most cases probably required more preliminary levels of risk assessment. The evidence on enforcement practice therefore resonates with the approaches to control of hazardous chemicals developed by the HSE outlined in previous sections and with the proposed OEL Framework. Here again, while monitoring airborne concentrations of hazardous chemicals in relation to their OELs was not ruled out for duty-holders with the resources to do so, it was not central to the broader strategy. In this strategy OELs functioned most significantly both in signalling the need for control and in specifying the most appropriate means of achieving it. The new Framework was therefore unlikely to require significant change in the role of OELs in existing inspection practices.

CONCLUSIONS: APPLYING THE NEW FRAMEWORK IN PRACTICE At the time of writing the new OEL Framework is not yet in force. However, as the preceding pages have outlined, a UK model for controlling the risks of hazardous substances at work that has developed over the past 20 years and in which the Framework sits is now well established. The role of OELs has

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undergone a particular evolution within this model. Starting with the incorporation of what was essentially the ACGIH list of TLVs into UK regulation and guidance in the early 1980s, the regulatory position of OELs was central to the introduction of principles of good occupational hygiene practice that characterised the COSHH Regulations. At this point as well as putting in place mechanisms for setting new OELs, the Regulations introduced two categories of OEL, the OES and the MEL. However, evidence of the lack of understanding and use of OELs, coupled with concerns about aspects of the process of setting them, what they represented in terms of safety, and the growing evidence that they played only a limited role in enforcement, as well as the recognition that substances with OELs were only ever likely to represent a small proportion of all substances in use at the workplace, led to a reorientation of the thinking behind their role in regulating the control of substances hazardous to workers' health at the workplace. The new thinking combined some of the generic approaches that had emerged to managing risks of hazardous substances in specific industries and processes, with suppliers' information requirements on the health risk of their products and the production of official guidance on control. It gave the generic control solutions that resulted more widespread application. Such approaches, it was argued, largely obviated the necessity for monitoring airborne concentrations of hazardous substances to ensure compliance in comparison with OELs (although it did not prevent them from being undertaken in situations where this could be carried out competently). It also shifted the position of OELs from being tools involved in monitoring compliance to being indicators of specification in the design and implementation of control techniques in a scenario in which regulatory emphasis was on linking principles of good practice with compliance with OELs through requiring employers both to apply principles of good practice and not exceed the relevant OEL. Their current role, as defined by the Framework, as well as relating to the development of the approach to regulating chemical risk also has several features that resonate with the wider profile of regulation of the work environment generally in the UK. This wider profile includes emphasis on the 'network of production* in which suppliers, users and regulators are involved in a mesh of economic, social and regulatory relationships. The emphasis on the role of the supply chain as a major source of information and influence in relation to chemicals fits with the wider perspective on regulating health and safety management generally.

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It is also clear that policies aimed at achieving improvements in health and safety in relation to small firms, and in increasingly fragmented work organisations, no longer rely solely on traditional means of informing and enforcing compliance with regulatory standards. It is now broadly accepted that such approaches have limited relevance to the experience of work in these situations and additionally are insufficiently resourced to reach any more than a small element of the vast array of work situations that can be thus categorised. These conclusions have underpinned a major shift in the focus of regulatory strategies on health and safety in the UK in recent years. They are prominent for example in the HSE Small Firms Strategy211 in which levers and pressures in the socio-economic environment, as well as intermediary actors and organisations are identified as important elements that can be exploited to achieve better compliance with regulatory standards amongst small firms. As well as making advice and information more relevant to the needs of small firms generally, the use of intermediary actors, partnerships and processes is identified as an important element in the social amplification of the necessity for relevant risk management strategies in these situations. The problem of understanding and use of OELs was most extreme amongst small firms. Measures to address this through utilising the intermediaries and sources of information that evidence points to owner managers in small firms using and trusting most, coupled with simplified and generic approaches to control is therefore best understood within the above broader strategy for regulatory intervention in these firms. Additionally, recent regulatory policy places considerable emphasis on a 'multidimensional' approach to regulatory intervention in which inspection and enforcement is viewed as but one of a number of strategies to improve compliance with standards.212 Others include education and awareness raising, working with those most at risk, using intermediaries, finding ways to motivate senior managers and using sector wide initiatives, partnership, the supply chain and design as See for example HSE Small Firms Strategy (http://www.hse.gov.uk/aboutus/hse/policy/ strategy.htm). Also Walters (2001) and James et al (2004) for a critique of these approaches. See for example the Consultative Document on this strategy (HSE 2004a) and the 'HSE statement on providing accessible advice and support', www.hse.gov.uk/aboutus/plans/ index/htm.

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means to increase health and safety standards. According to HSE's own analysis OELs have played no more than a very minor role in formal enforcement actions. They are however probably significant as triggers for the consideration of 'multidimensional interventions' by inspectors and the new OEL Framework, with its reduced number of OELs about which more reliable evidence has been gathered, may prove even more useful in this respect, as well as providing clearer and more accessible information for owner managers, higher risk enterprises and at sectoral levels. While OEL framework and its reorientation of emphasis for OELs resonate well with this wider strategic outlook, it is also important to note that both it and the wider outlook can be seen as essentially pragmatic responses on the part of poorly resourced regulators to a situation in which their limited means dictates recourse to other players and processes to intervene in their stead. Moreover, while there is relatively strong evidence that the traditional means of regulation such as inspection is successful, one criticism of the 'multidimensional' strategy is that there is far less reliable evidence that such other means as those identified above have anything like the same degree of success.213 At the moment the same might be said of the role of OELs in chemical risk management - that is - there is long-standing evidence to suggest that where they are used properly they are effective in the application of the principles of good occupational hygiene to manage the risks of hazardous substances. The fact that it has been shown that many employers, and especially those in small enterprises, do not use them properly is evidence of their lack of access to good advice and support. There is some evidence that when used appropriately the guidance on control that is now distributed as COSHH Essentials will provide the same level of good occupational hygiene standards but in much simplified and less resourceintensive ways gathered by practitioners in controlled circumstances (Russell et al 1998; Maidment 1998; Russell 1998; Tischer et al 2003). There is also some This point is made in relation to small firms in Walters (2001:3 80-84) and in James et al (2004). A report commissioned by the HSE also points out that many of the new ways of accessing contacting and influencing employers are untested (Greenstreet Berman 2004). A study for the Centre for Corporate Accountability provides an extensive review of the international literature and strongly supports the role of enforcement, as does a more analytical Canadian study on the international literature which argues that there is strong evidence that enforcement action improves health and safety performance with better effect than other approaches ( Davis 2004; Tompa et al 2004).

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evidence of the uptake of the COSHH Essentials guidance by users. However, there is little evidence that COSHH Essentials is reaching the full extent of the number and spread of potential users. Equally important, there is little evidence that COSHH Essentials is used properly by the firms that have accessed it. Just as the application of good occupational hygiene principles rely on preconditions such as the availability of expertise, resources to support it and incentives that influence employers' willingness to utilise it, there are preconditions that will determine the effective uptake of the current COSHH approach. They probably include: -

incentives for employers to use COSHH Essentials, including the role of enforcement if they fail to sufficient OHS competence on the part of employers to appreciate why the approach is necessary good access to COSHH Essentials advice access to good quality suppliers' information dissemination of this information to workers, their supervisors and representatives.

There is so far very little information concerning the extent to which such preconditions are in fact in place. Critics of the current UK strategy have pointed out that one of its aims is to obviate the need for occupational hygiene expertise by firms that do not think they have access to it - this is particularly so in relation to measurement and control issues especially in relation to the role of OELs. Yet, under UK and European regulatory requirements employers are required to discharge their OHS duties competently or through the use of competent advice. Conventionally in relation to OELs competent expertise exists in the form of occupational hygiene practitioners who are employed in the safety, health and environment departments of large organisations or act as consultants operating independently or as part of more comprehensive external prevention services. In the UK, unlike in most other EU countries, the regulatory requirements on the role of such competent advice loosely interpret the measures of the Framework Directive and leave a considerable degree of discretion to employers as to whether they choose to use this expertise. Furthermore, unlike some other EU countries, in the UK the role of consultants and prevention services is entirely market based. There are virtually no legislative requirements concerning the composition or quality of prevention

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services, nor are there any means with which firms can access their services without having to pay for them directly.214 Under such circumstances it is therefore not surprising that they are mainly the preserve of large organisations that have both the awareness and resources available to utilise them. Furthermore in such an unregulated environment those services that are available to smaller, less well-resourced clients may not themselves actually have the relevant occupational hygiene expertise to be able to advise on issues involving the measurement and control of chemical hazards and the use of OELs competently.215 An alternative approach therefore would be one in which there was greater specialist support for employers, including those in small firms, who are significant users of hazardous chemicals. This would probably require the implementation of some elements of a more 'European' approach to external prevention services. Such views were quite forcefully expressed during the consultation exercise on the new OEL Framework. As a former president of Institute of Occupational Hygienists (one of the professional bodies accrediting occupational hygienists in the UK) put it (Allen 2004:9): 'Defining and implementing effective exposure controls appropriate for the task and affordable to the employer, is crucial to avoiding harm to Many EU countries have explicit requirements on employers to use occupational health and safety advice (Vogel 2001). Many also have requirements concerning the competency of the services that provide such servies and some (such as the Netherlands and Denmark for example) have certification requirements for occupational health and safety services, without which such services cannot function. Arguably, the vision of prevention services projected by the Framework Directive is an integrated service that provides a range of expertise that is capable of addressing the multi-dimensional range of elements frequently encounters in current work environment issues. This includes occupational hygiene (Walters, ed. 2002). An additional problem that is not unique to the UK may be that regulatory inspectors themselves do not have the necessary expertise to feel sufficiently confident to require monitoring and control measures involving the understanding and use of OELs from employers. This may be a factor in the low level of enforcement involving the use of OELs, which in turn fails to provide the incentives to employers to seek sufficient access to expertise to enable the competent use of OELs in monitoring and control of chemical hazards.

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individuals. Getting it right isn't always simple and easy, especially for small and medium sized enterprises. The best way to do this is to provide an effective occupational health and hygiene service to SMEs and for HSE to rigorously enforce the law where necessary...'

The special interest group on exposure monitoring of the British Occupational Hygiene Society expressed further concern that the effects of the new OEL Framework would be damaging to the collection of data on workplace exposures and to the survival of the professions that support preventive approaches to occupational health (Allen 2004:9): 'Occupational hygienists together with occupational physicians, occupational nurses, ergonomists, health and safety officers and others play a crucial role in the prevention of occupationally related disease. Without occupational hygiene it will be much more difficult to achieve this. Unfortunately [the Consultative Document on the OEL Framework] is set to undermine the foundation of occupational hygiene: the ability to define new workplace hazards by collecting and interpreting exposure measurements'. and 'Rather than diminishing the need for collecting exposure data the HSE should be encouraging collection of good quality exposure data for use in future epidemiological studies especially in SMEs.' That such notions are not merely a reflection of the protectionist approaches of professional interest groups is indicated by the expression of similar concerns by the Engineering Employers Federation (EEF), which according to Allen (2004:9) noted in response to the Consultative Document on the OEL framework, that: 'OELs appear to be blamed as being too complicated for companies to understand, leading to a failure of COSHH. However, the issue is in fact far broader and the failure of COSHH is basically down to a lack of knowledge within companies and a lack of proper enforcement.'

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The same body pointed out that contrary to the thinking of HSE over the past several years COSHH Essentials would not be an effective solution on anything like the scale envisaged; "There are many areas where COSHH Essentials simply does not work, for example in the construction industry, for peripatetic workers, and in maintenance activities.' The hygienists added that although COSHH Essentials was a useful tool it was 'not the panacea claimed by some' and it was insufficiently tried and tested to be accorded the role identified for it by the HSE. Notions of a greater role for occupational health professionals and more integrated preventive approaches that utilise their expertise are frequently dismissed as unrealistic in the UK because of the additional resources that are perceived to be required, because of the scale of regulatory change necessary and because current demographic realities suggest that there would anyway be insufficient expertise to meet demand. It is, for example, doubtful whether sufficient qualified hygienists still exist in the UK. The decline of the industries in which their skills were required has significantly reduced the number of existing hygienists and at the same time reduced demand for them has in turn led to reduced provision of the necessary specialist education and training thereby reducing their supply. Arguably however, such an approach to prevention services is necessary to meet the requirements of Directives such as the Framework Directive. Indeed, in the recent past the HSE has come some way to acknowledge the need to make special provision for specialist occupational health and safety advice for small firms and has supported several new initiatives in this area.216 While the OEL Framework and COSHH Essentials suggest a possible way forward, it is important to point out that it is only one way forward and that its critics have suggested other approaches. The strategy currently favoured by the

For example, there have been a series of pilot projects such as one for small enterprises in Scotland, one for the construction industry in Leicestershire and an occupational health, safety and rehabilitation service in Kirklees all of which involve access to third party problem solvers and signposting to specialist services. At the same time it also should be noted that the HSE's own national occupational health advisory service has been reduced to almost nothing and the post of Chief Medical Inspector abolished.

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state authorities however is a pragmatic response that fits comfortably with features of existing UK arrangements and the broader strategic thinking concerning the direction of their future development, without the need to find significant additional regulatory resources. It promotes achieving compliance with chemical risk management within a wider approach that emphasises voluntarism, manipulating the pressures and levers of the market, supply chain and the socio economic environment of firms, all of which are characterised by a market-based and business-friendly 'UK pic' way of thinking about improving health and safety. This pragmatic strategy, characteristic of a particularly British way of addressing health and safety issues, is not necessarily the only way in which they might be addressed. These are issues to which we will return in the final chapter when we will draw together insights into practices in the six EU countries that we have studied in detail.

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5 GERMANY

INTRODUCTION In this chapter we describe and analyse the system for setting and using exposure limits in Germany. Recent and as yet incomplete changes to this system mean that what is presented here represents an analysis of a system that is currently in the process of change. Some of its features are yet to be fully implemented. This has meant that to help to understand the significance of some of these new features many of the detailed experiences we discuss are those they are intended to replace. We aim to show the extent to which exposure to dangerous substances is monitored, the role of inspection and control agencies in this process and how well companies follow their obligations to respect limit values. We will do so by focussing on the example of two substances and concentrating on practices in the three industrial sectors where their occurrence is relatively frequent - thus following the brief of the original study on which this book is based (Walters et al 2003). The two substances concerned are toluene and wood-dust and the three sectors, printing, metal working and wood-working in the furniture industry. Of course, entirely limiting the study to three branches and two substances would be somewhat restrictive. This would be particularly so when trying to analyse the development of the role OELs in industry generally and its relationship with wider regulatory development, so we also focus more widely where it is appropriate to do so.

Limiting ourselves to considering the example of two substances was also restrictive when seeking an understanding of the role OELs might play in OHS management systems dealing with chemical risks and therefore here too we have sought a wider frame of reference. The reality of the situation at enterprise level is

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that workers are exposed to several hazards at the same time (not only dangerous substances and certainly not single dangerous substances). The approach towards prevention at both enterprise and OHS authority level is therefore more holistic. In two of the three sectors (printing and furniture industry) where toluene and wood dust play an important role, other health hazards like ergonomic issues and exposure to noise are, at least in bigger companies, considered to be more dominant. In particular in the printing industry, exposure to toluene is much reduced as a result of the development in technology (replacement of workers by robots, closed technologies etc. and the recycling and reprocessing of toluene as an expensive working 'tool'). This technological development is even more advanced in the metal sector where, it has played a role in reducing the use of toluene as a single substance to the extent that it is now very limited indeed. Where it is still present it is more often found in mixtures with other substances and its percentage content in these mixtures is often quite low. The primary driver of this reduction in the metal industry is legal requirements (like labelling or the obligation to follow quite restrictive health and safety protection measures at the work place when using pure toluene or toluene in mixtures above a certain concentration), in combination with the availability of suitable substitutes. Following a brief outline of the extent and effects of chemical exposures in Germany, because of the differences between the operation of the German regulatory system and those other countries in the study, we outline of some of the key features of the German system and its structures and procedures relevant to setting and using OELs. This is followed by a section on experiences in relation to wood-dust. It includes an outline of the hazards of wood-dust and the position of OELs in legislative arrangements. It describes the essential features of the woodworking and furniture sectors, before considering the evidence of surveillance of wood-dust within these sectors, in which exposure limits have featured significantly. Using the same structure we move on to consider the situation in relation to monitoring exposure to toluene in three of the principle sectors where the substance is in use. We conclude with a discussion of the salient issues that emerge from our review, that place the role of OELs in regulating chemical risk management in German workplaces in context.

Germany

173 173

THE BACKGROUND We begin by outlining two elements of the background to the role of OELs in health and safety in Germany. The first relates to the extent of the problem of exposure to chemical substances and the second concerns the regulatory framework in which measures to control this exposure are embedded.

THE EXTENT OF THE PROBLEM OF CHEMICAL EXPOSURE IN GERMANY The German chemical industry is the fourth largest industrial sector in Germany and provides for about 28 per cent of the jobs in the chemical industry in the European Union - compared with about 14 per cent each being provided in France and the UK, about 12,5 per cent in Italy, 8 per cent in Spain and about 4.5 per cent in the Netherlands.217 The chemical industry itself accounts for only 7.5 per cent of the workforce in the processing industry in Germany. If other processing sectors in which chemicals are widely used are included, such as motor manufacturing (13.3 per cent), electrical engineering (13.7 per cent), mechanical engineering (15 per cent) and the food sector (8.5 per cent) it suggests that more than 57 per cent of the workforce in the industry are likely to be regularly exposed to chemical substances at work. In addition to this of course, many workers in other sectors such as private services are also significantly exposed to chemicals in their jobs.218 However, the Gennan workforce considers itself less exposed to chemicals than their colleagues in most of the other European countries (EU 15). According to the Third European Survey of Working Conditions (European Foundation 2001) the percentage of workers who thought they were exposed to breathing in vapours, fumes, dust, or dangerous substances for all or almost all of the time at work was sigmficantly lower than that for the average for the EU as a whole with only 2.9 per cent of German respondents claiming they were exposed to chemicals all of the time — and 3.5 per cent almost all of the time (compared with the average of 4.9 per cent all of the time and 4.3 per cent almost all of the time in the EU 15 countries). According to the same survey, the German workforce also Verband der Chemischen Industrie (VCI) e. V. Chemiewirtschqft in Zahlen Ausgabe 2004. Data taken from the website of the German Ministry of Economics and Labour ht^://www.bmwE,tnind.de/Navigatiori/Wirtschaft/Braachenfokus/Industrie.

174 Beyond Limits 174

seems to regard themselves better informed than their colleagues in the rest of Europe: with 44.3 per cent of German respondents thinking themselves very well informed (EU 15: 40.2 per cent), and only 4.6 per cent (EU 15:7.3 per cent) not very well informed. We could find no study which links the extent of exposure to dangerous chemicals at the workplace to the occurrence of occupational diseases or occupational related diseases. However, the annual report of the German Federation of institutions for statutory accident insurance and prevention {Hauptverband der gewerblichen Berufsgenossenschafen - HVBG2'9) gives an idea of what the size of the problem might be. According to the 2003 annual report,220 56900 cases of suspected occupational diseases (2002: 62472 cases, 2001: 66784 cases) were notified to the Berufsgenossenschaften, out of which around 58 per cent could (directly or indirectly) be linked to chemicals. They included: -

diseases caused by chemical exposure (exposure to metals, gases, solvents or pesticides)

-

diseases of the respiratory tract, lung, pleura, and peritoneum (inorganic dust like asbestos, organic dust like wood dust, and obstructive lung diseases)

-

dermal diseases and dermal cancer.221

Cases of dermal (skin) diseases were by far the largest group (about 45 per cent of all notified cases).

The umbrella organisation for 35 individual Berufsgenossenschaften or institutions for statutory accident insurance and prevention for trade and industry, which are divided according to the branch they are representing. Hauptverband der gewerblichen Berufsgenosenschaften, Information published under statistics on their main web site - http://www.hvbg.de/e/pages/statist/bk/index.html. Headings taken from the official list of recognised occupational diseases (Berufskrankbeitenvenverordnung vom 20.6.1968 (Bundesgesetzblatt I, page 721) in der Fassung der 2. Anderungsverordnung vom 18.12.1992 (Bundesgesetzblatt I, page 2343) as hereafter amended. [Civil code or statute book]. Germany:German Government). http://www.baua.de/info/info0420051.pdf.

Germany 175 175 Germany

Of course, these cases only represent those officially notified to the Berufsgenossenschaften and listed in the official list of occupational diseases. A considerable number of occupational related diseases are not recognised within the German system and are therefore not mentioned in the annual report. It is also necessary to take into account the fact that links between occupational exposure to dangerous chemicals and the effects on the health of individuals exposed are in many cases very difficult to prove with certainty, in particular if the effects occur years after the exposure or are to the result of exposure of several similar dangerous chemicals. It can therefore be assumed that the numbers in the annual report of the Berufsgenossenschaften are conservative, and only represent a small fraction of all work-related diseases and illnesses which could be attributed to the exposure of workers to dangerous chemicals. This is supported by numerous studies performed by for example the German Federal Institute for Occupational Safety and Health (the State side)223 and the Institute for Occupational Safety and Health of the Berufsgenossenschaften (the insurance side).22* Another indication that the situation is far from being satisfactory can be found in the numerous publications that appeared in the context of the discussion of the new (revised) Ordinance on Hazardous Substances (Gefahrstqffverardnung)?2* in which the shortcomings of the existing system with respect to the protection of workers from the exposure to dangerous chemicals where discussed in broad detail.

REGULATING CHEMICAL RISKS — THE GERMAN HEALTH AND SAFETY SYSTEM IN OUTLINE In Germany, OELs represent one of many elements within a complex structure of external and internal tools, measures and considerations226 for managing health

http://www.hvbg.de/e/bia/pro/fbr_brosch_e.pdf. The transposition of Directive 98/24/EC (Chemical Agents Directive) into German national law. Legislation, OSH authorities and their surveillance and monitoring system etc,, financial aspects, interaction with environmental and other legislation, trade unions and workers

176 Beyond Limits 176

and safety at enterprise level. In addition to its complex structure the German OSH regulatory system has undergone considerable change in the recent past.227 Much of this change (particularly the development of a more holistic approach) has its origin in the transposition of the EU Framework Directive on Health and Safety (89/391/EEC). In order to understand the role of OELs within the German OSH system and compliance (or non-compliance) with them, it is important to remember that there is a dual system comprising both the State and its federal sub-structure and the institutions for statutory accident insurance and prevention {Berufsgenossenschaften or BGen). The statutory social insurance role of the BGen and the engagement of both employers and trade unions in their organisation is also important since it means that while the BGen do not themselves establish OELs, their role in the process makes the establishment of OELs, proof of compliance with them and possible adverse health effects for workers resulting from exceeding them, the subject of intensive and often controversial discussions at all levels. Opinions are often dominated by the nature of the role their source plays within the system. In practice these features help to make the mode of operation of the German system different from that of the UK and the other countries in the present study. Importantly the degree of operational decentralisation of the inspection system both federally and in terms of the role of the BGen is greater than in other countries. Furthermore the technical orientation of the system means that the considerable attention that is paid to issues of measurement and surveillance in some sectors of industry is interspersed with issues of inspection and control in a manner that does not seem entirely comparable with patterns in other countries. For example, we find a comparative wealth of information on exposure levels for wood-dust and toluene that have been generated by actions commissioned and in some cases undertaken by inspection agents of the dual system - from within the BGen but also from within the labour inspectorate of some of the 16 states

227

involvement and participation, economic situation in general and in certain branches etc. etc. Currently, the system itself is at stake, officially because of its inefficancy, the costs involved and the dublication of work. The critics say that this is only another step in direction to more deregulation which undermines the functioning of the system as a whole. We come back to this later.

111 Germany 177

(Lander) into which Germany is divided. Moreover, the information generated from these activities form impressive data sets on exposure levels and trends that perhaps tell us as much about compliance with the regulation of chemical risk management as the (much less apparent) records of enforcement actions might. The 'dual' regulatory system for occupational health and safety in Germany is based on two main pillars; -

the legislative and institutional system of the Federal Government and its L&nder

— The regulatory and institutional system of the institutions for statutory

accidents insurance and prevention (Berufsgenossenschafteri). The dual system of regulation has created different regulatory regimes with strong orientation towards the enforcement of a mass of technical rules. OHS legislation is dominated by Federal laws and regulations. The Lander are responsible for their execution and their surveillance through the Trade Supervisory Boards (Gewerbeaufsichtsdmter) or the National Offices for Industrial Safety (Landesamter fur Arbeitsschutz). The system is based on the Industrial Code 1869 (Gewerbeordnung). A general obligation for employers to organise and maintain workplaces, installations, machines and tools and to run businesses in such a way as to protect workers against life and health threatening hazards insofar as permitted by the nature of the business was included in its revision in 1891 (§ 120 a). Paragraph 120 (e) allows the possibility of regulations (Vemrdnungen) from the Minister of Labour and Social Affairs, or, where such action is not taken, from the authorities of the federal states. Its use resulted in a large body of detailed regulations supplemented by so-called 'generally recognised technical rules', representing a pattern of regulation that is typical for German technical law in general. The Labour Inspectorate (created in 1853) is responsible for monitoring and enforcement. Because of the general character of paragraph 120 (a) of the Industrial Code, the role of the Labour Inspectorate includes specifying orders for particular situations. This gives rise to a third form of decentralised regulation, in addition to the regulations and the generally recognised technical rules.

178 Beyond Limits 178

The second track of regulation and enforcement is that of the so-called Accident Insurance Law {Unfallversicherungsrecht), which dates back to the Industrial Accidents Insurance Act 1884 (Gewerbe-Unfallversicherungsgesetz), later included in the National Insurance Code \9\\{Reichsversicherungsordnung). This created the legislative base for accident insurance funds {Unfallversicherungstragef) of which the so-called gewerblichen Berufsgenossenschaften - Bgen - (industrial employers' liability insurance funds) are the most important. The Unfallversicherungstrager or BGen are autonomous bipartite bodies228 of the social partners229. They are funded by employers' contributions and membership is compulsory. Beside their compensation function, prevention of accidents is the first priority of the statutory accident insurance funds. This combination of duties dates from the above mentioned Industrial Accidents Insurance Act 1884 and was motivated by the idea that those responsible for the damage should investigate the causes of the accidents and initiate preventive measures. In order to undertake this task, the statutory accident insurance funds have the power to issue its own binding regulatory framework (the so-called Accident Prevention Orders - Unfallverhutungsvorschriften) and to implement and enforce it by its own Technical Inspection Service {Technischer Aufsichtsdienst). The Accident Prevention Orders have to be approved by the responsible Federal Ministry for Economy and Labour {Bundesministerium fur Wirtschaft und Arbeit). Schematically, the German OHS regulatory system can be represented as shown in Figure 5.1 (after Schaapman 2002).

228

Public corporations. Both their delegates' meetings as well as their board are organised according to the principle of parity, with employers and insured equally represented.

Germany Germany 179 179

Figure 5.1 The German OHS system

Federal Republic of Germany Occupational Health and Safety System i

Safety and Health Legislation Autonomous Health and Safety of the Federal Republic of Germany System of the Accident insurance (.8M4)and the 16 Federal States funds (UVT/BG) Law making Law making Federal government: Laws, Ordinances, Adoption of accident prevention Approval of accident prevention regulations regulations. Federal States: Laws and by the delegates' meetings Ordinances of the accident insurance funds (UVV) Monitoring (Gewerbeaufsicht) Monitoring (BG) Compliance with statutory provisions Compliance with accident prevention through the safety and health services regulations through the technical inspection service Co-operation and exchange of experience BG = Berufsgenossenschaften UVV = Unfallsverhutungsvorschriften UVT = Unfallsversicherungstrdger BMA = Bundesministerium fur Arbeit und Sozialordnung The rules of the federal state are general in character, both with respect to sectors and regions, whereas the rules of the Lander are regionally specific and those of the Berufsgenossenschaften apply to specific sectors and sometimes also specific regions. As co-ordination between both tracks of regulation is often insufficient, this can lead to overlapping and even contradictory rules (Gerlinger 2000).

180 Beyond Limits 180

Although we have used the conventional term and referred to it as a 'dual' system, the complexity of the German system is such that in reality it is 'multiple' rather than 'dual'. Every statutory insurance fund is authorised to issue and enforce rules for its own sector or region. Regulation is further fragmented because of its decentralised character, and because of the limited coverage of the Industrial Code in the first place, which has resulted in different regulatory regimes and different levels of protection accordingly, for different sectors.230 Moreover OHS law (as well as any other part of German technical law) is characterised by manifold references to private norms by way of the concept of 'generally recognised technical rules'. The transposition of the Framework Directive. Following a delay of three years after the official deadline for implementation of Directive 89/391/EEC,231 Germany finally adopted the Law on Safety and Health at Work,232 which officially transposed the European Framework Directive and subsequently its various individual Directives into German law. This development was praised, in particular by the trade unions, as a long overdue paradigm shift, enabling a fundamental modernisation of the traditional German occupational health and safety system, which until then had focused primarily on the prevention of accidents and occupational diseases by technical measures. At the core of the new legislation was - at least on paper - a fundamentally new approach to occupational health, that no longer equated health only with the absence of disease or inability to work but now considered its achievement as a process that could not be established by solely addressing technical working conditions but which needed to be promoted by a healthy occupational working environment overall.

The regulatory basis for commercial personnel, for example, is to be found in paragraph 62 of the Business Code (Handelsgesetzbuch), whereas for civil servants there is no similar OHS regulatory basis. The officially deadline was 31 December 1992, the German Law on Safety and Health at Work came into force on 21 August 1996. http://www.per.hqusareur.army.mil/services/safetydivision/Host per cent20Nation/HN per cent20Translation/E-ArbSchG.pdf.

181 Germany 181

The Law on Safety and Health at Work covered all the main elements of the European Framework Directive. Besides new and more holistic obligations for employers to manage risks in line with the approach of the Directive, the new law also changed other important elements of the German health and safety system, hi particular it repealed the disputed Article 120a of the Gewerbeordnung, which had often been used as an escape clause for employers to avoid taking necessary protective and prevention measures at the workplace. Secondly, it covered not only workers in the industrial sectors but also those in the public sector. Thirdly it had significant consequences for the general approach of the various players involved occupational safety and health at national, regional and enterprise level. The Berufsgneossenschaften were from now on obliged to involve themselves in studying the cause sand prevention of occupation related diseases. Public health and safety authorities and the Berufsgenossenschaften were now also required to co-operate in surveillance and to promote the exchange of information between them.

It appears that implementation of these quite major changes in the orientation of the system has not entirely lived up to expectations. According to trade union sources,233 no risk assessments have been performed in more than two thirds of enterprises, especially in SMEs. In this context it is also of interest to note that Germany is currently facing an infringement proceeding regarding its transposition of the obligation imposed by the Framework Directive for risk evaluation to be available in documentary form at all times.234 The Law on Safety and Health at Work only requires this only for enterprises with at least 10 employees. This obviously also leads to the situation where enterprises exempted from this obligation do not undertake risk assessments at all.235 The trade unions are also concerned about what they regard as a lack of consultancy, help and surveillance at enterprise level by both, public authorities and the Berufsgenossenschaften, and insufficient co-operation between the two enforcement authorities. Annually, public authorities visit only 10 per cent of

http://www.gutearbeit-online.de/atchiv/beitraege/2004/2004_07_21_23.pdf/ http://www.gufearbeit-online.de/archiv/beitraege/2004/2004_07_l 8_21 .pdf / http://www.beainten-aifornifltionen.de/niediabig/445A.pdf. http://europa.eu.int/eur-lex/en/com/rpt/2003/act0669en03/l,pdf. http;//www.igmetall.de/gesundheitfarbeit_aekologie/01_23_Ql.htinl.

182 Beyond Limits 182

enterprises and the Berufsgenossenschaften only 14 per cent of the enterprises for which they are responsible. At the same time the Government has announced proposals intended to further reform the dual system, including abolishing some of its main elements,236 together with other deregulatory measures and measures aimed at reducing bureaucracy.237

THE LEGISLATIVE FRAMEWORK FOR O E L S The legislative basis for OELs is the Chemicals Acts (Chemikaliengesetz2™) with its Dangerous Substances Regulation (Gefahrstqffverordnung119). The Act was last amended on 13 May 2004. The new Ordinance on Hazardous Substances came into force on 1 January 2005. hi addition to these basic acts, so called Technical Rules for Hazardous Substances provide for additional information when dealing with hazardous substances and list occupational exposure limit values (TRGS 900240 and 903241), carcinogenic, mutagenic and substances toxic to reproduction (TRGS 905242), or sensitising substances (TRGS 907243). The TRG 900 (MAK and

The main idea is to shift the responsibility for surveillance and execution tasks - so far shared by the public OSH authorities and the Berufsgnossenschaften - exclusively to the Berufsgenossenschaften. http://www.handelskammer-bremen.ihk24.de/HBIHK24/HBIHK24/produktmarken/ standortpolitik/ Buerokratieabbau/29-er-Liste-BMWA-12.05.04-lang.pdf. Gesetz zum Schutz vor gefahrlichen Stoffen (Chemikaliengesetz - ChemG) In the version of 20. Juni 2002 (BGB1.1 S. 2090, last amended on 13 May 2004 (BGB1.1 S. 952). Verordnung zum Schutz vor Gefahrstoffen (Gefahrstoffverordnung - GefStoffV) last amended on 23. December 2004 (BGB1.1 S. 3855). Grenzwerte in der Luft am Arbeitsplatz, Ausgabe October 2000, zuletzt geandert BarbBl. Heft 5/2004. Biologische Arbeitsplatztoleranzwerte - BA T- Werte, Ausgabe April 2001, zuletzt geandert BarbBl. Heft 5/2004. Verzeichnis krebserzeugender, erbgutverdndernder oderforpflanzungsgefdhrdender Stoffe, Ausabe Marz 2001, zuletzt geandert BarbBl. Heft 9/200. The TRGS 905 contains carcinogenic and mutagenic substances and substances toxic for reproduction and their German classification for which either a different or no classification has been established so far in Annex I of Directive 67/548/EEC. But they are only published in the TRGS 905 if neither MAK nor TRK value has yet been established. Verzeichnis sensibilisierender Stoffe, Ausgabe Oktober 2002.

Germany 183 183 Germany

TRK values) refers to about 900 substances or groups of substances, though the number of substances actually covered is much higher (for example, Beryllium and its compounds). Types of Occupational Exposure Limits until 31 December 2004. Until 31 December 2004, three limit values were in use in Germany: -

Maximum Workplace Concentrations (Maximale Arbeitsplatzkonzentrationen - MAK) Technical Guidance Concentrations (Technische Richtkonzentrationen TRK), and Biological Tolerance Value for occupational exposures (Biologische Arbeitsstofftoleranzwerte - BAT).

The first occupational exposure limit values were published in 1886. In 1938, about 100 OELs were presented during a congress in Frankfurt. In 1958, the first MAK-list was published; the values mainly based on the US TLV list. Since 1969, the MAK list has been published annually and independently from the TLV list. New limit value concepts from 1 January 2005. Since 1 January 2005, with the new Ordinance on Hazardous Substances coming into force, the former limit value concept (health-based MAK values and technically-based TRK values) underwent a fundamental change. The core piece of the new Ordinance on Hazardous Substances, which transposes the Chemical Agents Directive 98/24/EC into German law, is its risk assessment provisions which - based on specific occupations - will evaluate the physical-chemical risks arising from the various possible exposure routes. One fundamental change compared with the previous system is that in future only exposure to dangerous chemicals or mixtures will be evaluated and not any longer all chemicals / mixtures present at the workplace. The other important changes are the introduction of the new limit value system and the so-called 'traffic light system'. The new limit value system is based on two risk-based limit values: -

The workplace limit value (Arbeitsplatzgrenzwert or AGW) is a substance related limit value. If this value is respected, a risk to health is in general not to be expected.

184 Beyond Limits Limits 184

They will be derived with classical methods like those used for deriving the former MAK values. In the cases of carcinogens a 'suitable' calculation method will be used resulting in a value which reflects a determined 'acceptable' risk. The technical limit value (Technischer Grenzwert or TGW). This is also a substance specific limit value. However, compliance with this limit value does - according to the scientific data - not exclude a risk to human health. They will be established for certain production processes and / or occupations for which it is foreseeable that the AGW cannot be respected. It is possible to derive different TGWs for the same substance but different occupations and / or production processes. The fundamental difference between the new TGW and the former TRK is that the TGW is based on what is called a 'tolerable' risk.

According to the 'traffic light system' there is a 'green zone / area' if the AGW is not exceeded. Additional measures to reduce the exposure to the substance via inhalation are not required (the so-called 'acceptable' zone / area). No 'relevant' risks to human health can be expected. An 'amber zone / area' exists if the AGW is exceeded (the 'tolerable' zone / area), Here a health risk must be assumed for the exposed workforce. To continue work under these conditions requires additional measures (like personal protective equipment) and an authorisation from the surveillance authority is necessary. A 'red zone / area' exists if the TGW value is exceeded or if the measures required by the surveillance authorities are not respected. In general, work under these conditions is not allowed. However, under certain circumstances or for certain activities (e.g. tunnel construction, cleaning of vessels and tanks, work to remove asbestos etc.) in which the TGW cannot be respected, exemptions are foreseen. This new system requires a complete review of the Technical Rules, not only the Technical Rule 900, under which the MAK and TRK values were published. Until this revision has been completed, the technical rules will continue to be used as guidance. At the time of writing no new Technical Rules are yet available however, some of the basic parameters as described below (e.g.: the reference

Germany 185

period) that are taken from the requirements of the former system will very probably also remain be valid for OEL s under the new Technical Rules. Definitions and other parameters.244 The MAK were defined as the concentration of a substance in the air at the workplace which generally does not impair the health of workers.245 According to this definition, MAK values could only be established for those substances, for which a No Observable Adverse Effect Level (NOAEL) or a Lowest Observable Effect Level (LOAEL) could be determined and they were therefore - in theory - health based, 'hi theory', because initial health-based recommendations of the MAK Commission (Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area)246 were discussed and eventually changed for socio-economic reasons by the Committee on Hazardous Substances before being finally adopted. For substances like genotoxic carcinogens or mutagenic substances Category I or II (according to the EU classification for hazardous substances), a NOAEL or LOAEL cannot be established. To minimise exposure to these substances, TRK values were established, reflecting the 'airborne concentration of a hazardous substances which can be achieved with the available techniques'.247

Orenzwerte in der Luft am Arbeitsplatz, Ausgabe October 2000, zuletzt geandert BarbBl. Heft 5/2004, This definition is less comprehensive than the one from the MAK Commission according to which "The MAK value is the maximum allowable concentration in the workplace of a working material in the form of gas, vapour, or air-suspended matter which, according to the present state of knowledge, generally does not impair the health of the workers and does not inconvenience them unduly, not even on repeated and prolonged exposure ...' And 'In establishing MAK values, the main consideration is the characteristic effects of the materials, but as far as possible consideration is also given to the practical conditions of the working processes or of the resultant exposure pattern.' MAK- und BAT-Werte-Liste 2004, Mitteilung 40 der Deutschen Forschungsgemeinschaft (DFG), August 2004. 'What finally matters is the scientifically based criteria of industrial hygiene, and not the technical and economical possibilities of implementation in industrial practice.' MAK- und BAT-Werte-Liste 2004 ibid. Grenzwerte in der Luft am Arbeitsplatz, Ausgabe October 2000, zuletzt ge&ndert BarbBl. Heft5/2004.

186 Beyond Limits 186

The new established AGW are defined248 as the threshold for the time-weighted average concentration of a substance in the air at the workplace in relation to a certain reference period. It represents the concentration of a substance at which acute or chronic adverse health effects are not to be expected in general. By introducing AGWs, the procedure of assigning technical limit values for substances and mixtures (in general for carcinogens) for which a health based value is not achievable at the workplace, is abandoned and replaced by a riskbased system. MAK and TRK values were established for single substances (not for mixtures), expressed in ml/m3 (equivalent to ppm - parts per million) for volatile substances and in mg/m3 for non-volatile substances and defined at 20°C and 101.3hPa. They were time-weighted shift averages of normally eight hours daily under the condition of an average weekly working time of 40 hours. For four-shift-premises, the basis was 42 hours per week on average for four consecutive weeks, hi addition, substance-specific exceeding factors of the time-weighted MAK/TRK value were established (between one and ten times of the MAK/TRK value), as well as their duration, their maximum frequency per shift, and the minimum time between two events where the MAK value is exceeded. BAT values are still health-based and are now defined249 as the threshold (derived on the basis of toxicological and medical reasons) for the concentration of a substance, its metabolite or a stress indicator in a specific biological fluid, at which the health of the worker is in general not adversely affected. They were expressed as concentrations, formation or clearance (amount per time unit) of a certain substance or a metabolite either in blood or urine. As for the MAK/TRK values, BAT values were calculated on the basis of an exposure of eight hours daily under the condition of an average weekly working time of 40 hours. Rules for simplified risk assessments of mixtures of substances are established in the TRGS 403,25° based on the concentration of each individual substance, not

Verordnung zum Schutz vor Gefahrstoffen (Gefahrstoffverordnung - GefStoffV) last amended on 23 December 2004 (BGBl. IS. 3855). Verordnung zum Schutz vor Gefahrstoffen (Gefahrstoffverordnung - GefStoffV) last amended on 23. December 2004 (BGBl. I S. 3855). TRGS 403 - Bewertung von Stoffgemischen in der Luft am Arbeitsplatz Ausgabe Oktober 1989 (BArbBl. 10/1989 S. 71).

187 Germany 187

taking into account possible synergistic or antagonistic effects. Additional specific rules applied for substances or group of substances occurring as dusts, gases, vapours, mists and fibres. Substances which can be absorbed in large quantities via the skin were assigned an 'H' in the TRGS 900. This required the application of specific protection measures in addition to the MAK value. Possible gender specific sensitivities were also not taken into account, though specific restrictions exist with regard to CMR251 substances for pregnant and breastfeeding women, and women who have recently given birth. Procedures for setting OELs. The Technical Rules for Hazardous Substances (Technische Regeln fur Gefahrstoffe - TRGS) and therefore also the TRGS 900 (MAK and TRK values), the TRGS 903 (BAT values) and the TRGS 905 (Inventory of CMR substances) were established by the Committee on Hazardous Substances {Ausschufi fur Gefahrstoffe - AGS) and adapted by the Committee to the current status of development. This will also be the case in the future for the new AGWs. The Committee is an Advisory Committee to the Federal Ministry of Labour and Social Affairs. After having been adopted by the plenary meeting of the Committee on Hazardous Substances, which meets twice a year, the Ministry announced the Technical Rules in the Federal Labour Gazette (Bundesarbeitsblatt - BArbBl.). It252 is a statutory body (§21 Ordinance on Hazardous Substances253). It has 40 members, who belong to various interest groups, including representatives of: -

social partners

-

federal and Lander authorities

-

producers and manufacturers of hazardous substances

- berufsgenossenschaften -

the MAK Commission.

Carcinogenic, mutagenic or toxic for reproduction. http://www.baua.de/prax/ags/ags_allg.htm. Verordnung zum Schutz vor Gefahrstoffen (Gefahrstoffverordnung - GefStqffV) last amended on 23 December 2004 (BGBl. IS. 3855).

188 Beyond Limits 188

It has several sub-committees and working groups (some permanent, some established for specific tasks). The various interest groups are also represented within these sub-committees and working groups. Within the relevant subcommittee^), the MAK and BAT recommendations of the MAK Commission were discussed, as well as OELs established by other bodies (e.g. the EU). Based on these discussions, the sub-committee(s) proposed MAK and BAT values to the plenary meeting for final approval. TRK values were developed within a specific sub-committee and also forwarded to the plenary meeting for final approval. Both types of recommendations were finally discussed, eventually changed again and finally approved by the plenary meeting of the Committee for Hazardous Substances. The MAK Commission254 is a scientific expert group of the German Science Foundation {Deutsche Forschungsgemeinschaft — DFG). Each year the Commission publishes its MAK and BAT value list (1 st July). These values are based on toxicological, occupational hygiene and analytical considerations; they are therefore health-based but not legally binding (see above). Legal status of Occupational Exposure Limits. So far, all limit values are legally binding as soon as adopted by the Committee on Hazardous Substances and published by the Ministry of Labour and Social Affairs. Non-compliance is an infringement of the law (the Chemical Act) and/or its Ordinance on Hazardous Substances. This will not change in the future. In cases where the life or the health of an employee is at risk, non-compliance can become a criminal offence. As a consequence, fines of between EUROS 15,000 to EUROS 25,000 can be charged for infringements or non-compliance with demands of the surveillance authorities. In cases where demands of the surveillance authorities are ignored repeatedly or where the health and/or life of an employee are endangered, a prison sentence of one year or fines are possible.255 In cases where the Accident Prevention Regulations of the institutions for statutory accidents insurance and prevention are ignored or violated, the

http://www.dfg.de/organisBtion/gremien/mak.htinl. Gesetzzum Schuti vor gefihrlichen Stoffen (Chemikaliengesetz - ChemG) In derFassung vam 25. Mil 1994 (BGB1.11994 S. 1703;.1994 S. 1963; 1994 S. 2705; 1997 S. 1060; 1998 S. 950; 2000 S. 1045,2048; 2001 S. 843,2001 S. 2331).

Germany 189

institution can also impose fines and higher mandatory contributions on the employer.256 What is meant by compliance? Compliance with a MAK value meant that the value was not exceeded (allowing for the exemptions mentioned above for peak exposures etc.). Compliance with TRK values meant that they should not be exceeded and that working conditions should ensure a concentration significantly below the established value. To ensure this, the employer has an obligation to assess and evaluate the concentration of dangerous substances at the workplace (TRGS 402257). The assessment and evaluation is divided into four steps: 1. An assessment of the hazardous substances and their limit values at the workplace. 2. Collection of basic information about the type of work, the production process, the machinery and techniques involved, ventilation facilities, amount of substances, temperature etc. for the specific work place. 3. Collection of additional information on possible exposure scenarios (including exposure peaks, comparison with similar plants, first measurements etc.). 4. Based on the information gathered in steps 1 to 3, an assumption has to be made whether or not a permanent compliance with the limit value can be achieved. If this is not the case, the employer is obliged to perform measurements of the exposure according to a detailed plan, including the measurement technique, the number and frequency of measurements (depending on the exposure scenario calculated on the basis of the assessment in steps 1 to 3). If the limit value is exceeded, immediate action to reduce the concentration has to be taken. Results of the exposure measurements have to be kept for 30 years. Who enforces the Exposure Limits? Compliance with the established limit values is enforced by the labour inspectors of the National Offices for Industrial Safety of the Bundesldnder. The National Offices for Industrial Safety, which the Labour Inspectorate (Gewerbeaufsicht) is part of, are normal authorities (Behorden) of the

http://www.hvbg.de/d/pages/kostei^eitrag/beibei.htm. TRGS 402 - Ermittlung und Beurteilung der Konzentrationen gefahrlicher Stoffe in der Luft in Arbeitsbereichen Ausgabe November 1997 (BArbBl. 11/1997 S. 27).

190 Beyond Limits 190

responsible Ministry at State level. The following powers are given to the inspectors of the Gewerbeaufsicht25*: ~ enter, investigate and monitor workplaces at any time -

require from the employer the information and documents necessary for them to fulfil their task

-

perform technical checks and to receive the technical assistance (manpower, tools etc.) to do so

-

collect material samples and to analyse them

-

consult experts.

For the execution of their tasks, inspectors have the same powers as the local police. They may issue orders and make use of compulsory measures/sanctions under the relevant State laws. Normally this covers a remedy of the situation at the expense of the employer or the establishment and/or the fixing of fines. Additionally, they can order the suspension/cessation of production or initiate ongoing penalties. The institutions for statutory accident insurance and prevention and their Technical Inspection Service are also responsible for the surveillance of the Hazardous Substances Regulation and its Technical Rules. As well as this, the BG may also require higher mandatory contributions from the employer. Both surveillance authorities offer special support for small and medium sized enterprises with respect to training and measurement techniques. In addition to 'external' surveillance, an internal system for ensuring compliance with the health and safety provisions is in place. This is composed of safety engineers and the occupational medical support service (which is mandatory for companies of a certain number of employees), as well as representatives of the workforce. Regular meetings between the management and other people responsible for health and safety within an enterprise are mandatory. Enforcement activity. There is little information that is easily available on the extent to which OELs feature in the enforcement activities of either the state or insurance authorities. Both the National Offices for Industrial Safety and the

Gewerbeordnung (GewO) in der Fassung der Bekanntmachung vom 22. Februar 1999 (BGBl. IS. 202.

191 Germany 191

institutions for statutory accident insurance and prevention collect and publish annual reports on their surveillance and enforcement activities. They include information on the number of inspections, the types of notices issued, fines charged etc., as well as strategic targets and plans for forthcoming years, but they do not contain direct reference to infringements involving OELs. These reports cover all health and safety activities and not only those linked with hazardous chemicals and the enforcement and surveillance of occupational exposure limit values. In the annually published report of the Federal Ministry of Economy and Labour,259 no direct mention of infringements of the H&S legislation in the field of dangerous chemicals and exposure limit values is made. Emphasis is on the number of occupational accidents and occupational diseases; their development classified by sector, occupation, BundeslUnder (States), and various other criteria, costs linked to occupational accidents/diseases, developments in the working population etc. No data on chemical exposure or infringements of OELs is available in these reports. Exposure data. Good sources for exposure data are the databases of the Berufsgenossenschaften and the publications based on them. Within the framework of the Berufsgenossenschaften '$ measuring and supervision tasks, the BG measuring system for hazardous substances (BGMG)260 records exposure data from about 4000 enterprises since the beginning of the 1990s. Meanwhile, about 70,000 samples are taken and analysed annually.261 Particular emphasis is placed on carcinogenic substances for which some 3,000 readings are taken every year. The operational data obtained within the framework of workplace measurements, together with the results themselves, are recorded in the DOK-MEGA databank of the Berufsgenossenschaftliches Institutjur Arbeitssicherheit (BGIA).262 All data are stored in the database with up to 150 pieces of individual information (describing type of workplace, working conditions, measured substances, sampling strategy, sampling duration, sampling and analytical method etc.), for each result. MEGA contains currently about 1,400,000 measurements of more than 400 substances and biological agents. http://de.osha.eu.int/de/docs/uvb2000/SuGA2003Gesamt.pdf. http://www.hvbg.de/d/bia/fac/mega/jour/bia_bgiiig.pdf. http://www.hvbg.de/d/bia/pub/ada/pdffabia0021.pdf. http://www.hvbg.de/dMa/pub/ada/pdf7abiaO2O7.pdf.

192 Beyond Limits Limits 192

The data is used by the Berufsgenossenschaften for a number of purposes including: prevention (e.g. identification of hazards, efficiency of exposure reducing measures, determination of technical criteria for exposure limit values), epidemiological studies and investigations of occupational diseases. In the framework of the measuring and inspection activities of the BGs the locations for measurements are not randomly selected but focus on critical exposure situations and testing the efficiency of exposure reducing measures. Nevertheless, a statistical appraisal of the data is possible for different purposes considering the specific determinants of the results, as for example classification of enterprises (sectors), workplaces (activities, tasks), used materials and products (Stamm, 2000). Unfortunately, this data is not available for the general public (the data are normally only available for the BGen and their members) and it is not clear whether a detailed analysis of the data collected here would reveal information on enforcement practice in relation to OELs. Both surveillance authorities (The BGen and the State labour inspectors) visit companies for different reasons: a) because certain types of companies / a certain sector etc. are part of a pinpoint action or similar b) the surveillance authorities have a suspicion requiring investigation (based for example on the information they received from a work council in a certain company) c) there is an accident. Based on their experience and on the model work place conditions established by former pinpoint actions or studies performed by the BGen or the public authorities, inspectors know or can be fairly certain if working conditions are according to the law or not. They might either measure themselves or urge the company to present the relevant data if they think there is something wrong, but this would be only additional information, either supporting or not supporting the already existing suspicion. Generally, it is felt that there is no need to measure, if all the other surrounding circumstances (compared with standards established by the BGen or the State Authorities themselves) indicate that the OELs are respected (if the employer is for example using the recommended machinery and exhaust or ventilation system). Because measuring is so expensive, everybody tries to avoid it by having other tools (comparable working condition, machinery

Germany

193 193

according to standards etc.) from which the relevant conclusions can be drawn. Pinpoint actions are the main source of OEL measurements. But because the are performed in order to improve working conditions according to the state of the art in technology and knowledge about health hazards, they are not considered as being enforcement activities but as guidance and help for companies. As a member of a BG, a company is entitled to receive help. If a State Authority finds working conditions they consider unacceptable or improvable, guidance is also given in the first place because nobody is interested in undertaking the kind of 'enforcement action' that risks destroying companies and workplaces.

WOOD DUST Hazards. According to the Technical Rule for Hazardous Substances N° 901, Wood dust is recognised as being associated with the following hazards: — Fire and explosion (it can form explosive mixtures with atmospheric oxygen). — Sensitising effects on the respiratory tract and the skin is documented for domestic and tropical timber. — Oak and beech wood dust have been classified as carcinogens, category 1 (known human carcinogens) since 1986. Unspecified wood dust as such is classified as a carcinogen, category 3 (known or suspected carcinogens with limited evidence). (Technical Rule for Hazardous Substances N° 905. In 1987, the atmospheric limit value for wood dust (the TRKaa value) was established at 2 mg/m3 for new plants and 5 mg/m3 for old / existing plants. Since 1996, the 2 mg/m3 value,264 measured as inhalable ('E')26* dust (Technical Rule for Hazardous Substances N° 900), applies to all workplaces where wood dust is generated. At European level, the limit value for hardwood dust is 5 mg/m (Council Directive 1999/3 8/EC).

Technische Richtkanzentration I technical guidance concentration. 264 MS

With a ceiling value for peak exposures of 4 times this TRK value. Former 'total' drat.

194 Beyond Limits Limits 194

Relevant legislation at national level. In 1986, the so-called ZH 1/139 was published for the first time, a regulation of the BG, which deals with the extraction and separation of dust and chippings. This regulation was updated in 1990 but withdrawn completely in 1993, after the TRGS 553 (see below) was published. In 1992, all rules concerning the use of wood dust were summarised and consolidated in the so-called Technical Rule for Hazardous Substances N° 553 (TRGS 553), including requirements for technical tools and equipment as well as organisational measures when working with wood. Workplaces and machinery for which the OEL is currently unachievable due to the (less developed) state of the art in the available technology, constitute a socalled 'negative list', which was published the first time in 1994. For those workplaces / machinery a limit value of 5 mg/ m3 is allowed together with the obligation to minimise the exposure. It is published as Annex 2 of the TRGS 553. The list has to be up-dated regularly by the German Committee for Hazardous Substances (AGS266), normally based on data collected by both the institution for statutory accident insurance and prevention in the woodworking industry267 and the State Offices for Labour Protection in the Lander. The aim of each revision is to shorten the list until no workplace / installation is exempted any longer from the lower limit value of 2 mg/m3. Based on the results of the last measurement series, the 'negative list' was revised in March 2002. The TRGS 553 also determines when the more stringent provisions of the Ordinance on Hazardous Substances foreseen for carcinogens have to be applied when working with wood that contains either oak or beech wood or both.268 The Ordinance on Hazardous Substances in conjunction with the Technical Rule for Hazardous Substances (TRGS 402) also lays down how to determine and to assess the airborne concentration of dangerous substances in work areas and whether or not work areas can be exempted from exposure measurements.269 This

Ausschufifur Gefahrstoffe. Berufsgenossenschaft Hoh I in the following: BG Holz. The percentage of oak and / or beech wood has to be higher than 10 per cent of the total annual amount of wood use in the company. Notwithstanding the fact that whether or not a work area is exempted from exposure measurements, other obligations of the employer according to the Ordinance of Hazardous Susbstances remain in force such as its obligation to use less hazardous substitutes if

Germany 195

is the case 'when the limit value can be guaranteed securely and permanently'. This means that no exposure measurements have to be performed if a work area under scrutiny fulfils certain requirements with respect to ventilation, machinery etc. This is important as many activities from all stakeholders aim at establishing this type of criteria in order to avoid expensive measurements and also to facilitate the task of the labour inspectors. The industry. The woodworking industry in Germany consists mainly of furniture making, prefabricated housing and construction elements, wood-based materials and other wooden material production. The two sectors of the industry that are of interest in this account are woodworking and furniture manufacture. As is the case in a number of other industries, the woodworking and furniture industry remains in a difficult economic position and demand in the domestic market has been weak in recent years. In 2003 sales of the entire woodworking industry fell by 2.2 per cent compared to the previous year and amounted to €36 billion. The number of businesses dropped by 5.2 per cent to around 3,000 while the number of employees decreased by 6.8 per cent to around 237,000. In short, the sector is slowly declining, partly due to the low demand in Germany itself where the markets for the industry are concentrated. The woodworking and furniture industries are typical representatives of small and medium-sized businesses and as such are confronted with the massive market strength of the big purchasing associations. The majority of businesses in the sectors consist of 20 to 50 persons, though companies in the furniture industry tend to be larger than those of the wood processing industry. Within the furniture industry a slight shift towards larger companies has taken place in recent times and about 40 per cent of turnover is produced by companies with less than 200 employees.

available, to respect the hierarchy of protective measures, to equip every workplace with operating instructions and to perform regular training for the workforce.

196 Beyond Limits 196

Table 5.1 Number of businesses in woodworking and furniture270 Sector Wood Furniture Total % of total industry

1999 1988 1988 1470 1470 3458 7.3

2000 1912 1912 1418 1418 3330 7.0

2001 1833 1833 1393 1393 3226 6.8

2002 1681 1681 1339 1339 3020 6.5

2003 1566 1293 2859 6.1

Because furniture production in Germany is decreasing, employment rates also decrease. The number of employees in the manufacturing sector have decreased in general and not only in the wood sector. Reasons for this decrease are the economic instability and uncertainty as well as the growing competition of countries with lower production costs. Table 5.2 Number of employees in woodworking and furniture'.271 Sector Wood Furniture Total % of total industry

1999 114,369 114,369 165,541 165,541 279,910 4.5

2000 113,547 113,547 161,398 161,398 274,945 4.4

2001 106,226 106,226 157,412 157,412 263,638 4.2

2002 96,419 147,684 244,104 4.0

2003 89,225 137,298 137,298 226,523 3.8

Surveillance of Compliance with OELs for wood dust over recent years. There are several reasons why workplaces where wood dust is generated have been monitored quite intensively since the end of the 1980s. Probably most important reason has been the 'negative list* of the TRGS 553. This implies a threat that the Committee of Hazardous Substances will withdraw workplaces and / or machinery mentioned in this list if no data is supplied when the list is revised. It is Sources for Tables 5.1 and 5.2 are: http://www.igmetaU.de/branchea/holzlaiMtstorr/branchenspiegel.hnnl. http://trademBeting.dynamioweb.dk/Default.asp?ID=1252, http://www.bmwa.btmd.de/Navigfltiori/Wirtschaft/Branchenfokus/Iri(iustrie/moebel-undholzindustrie.html. Sources for Tables 5.1 and 5.2 are: ht^://www.igmetaU.de/brmchen/holz_]ainststonvl)rancheiispiegel.html. http://trademeeting.dynamicweb.dk/Defiiult. asp?ID=1252. http://www.bmwa.bund.de/Navigation/WirtscharVBranchenfokjis/Industrie/moebel-undholzindustrie.html.

Germany 197 197 Germany

therefore in the interest of the industry to have data available which proves that certain workplaces and / or machinery is still not able to achieve the lower limit value, otherwise they may be withdrawn and the lower limit value of 2 mg/m3 will then apply to them. As a result, there are a number of organisations that have been involved in undertaking a variety of different studies in the sector monitoring wood-dust exposures. They include: -

Studies undertaken in different enterprises and sectors of the wood working industry by BG Holz to support its members in fulfilling legal requirements and to improve the technology within the sector.

-

Several pinpoint / targeted actions performed by the State Offices for Labour Protection because they had evidence that the working conditions in certain branches / sub-branches of the wood working industry were not in accordance with the legislation in force.

-

Research institutes like the Research Institute for Hazardous Substances which offers professional help for enterprises by performing risk assessments according to the Ordinance on Hazardous Substances, have performed workplace atmosphere analyses and control measurements in different sectors of the wood working and wood processing industry. This type of professional help normally includes advice for possible technical measures to reduce exposure.

-

Many exposure measurements of different types of work areas have been performed in order to establish criteria and requirements under which the limit value can be guaranteed permanently and securely to exempt companies meriting these criteria from performing exposure measurements.

-

Numerous measurements have been carried out in projects in which BG Holz is involved that are funded by the European Union, which aim at preparing exposure registers of hazardous substances in the woodworking industry.

Further examination of these activities gives an indication of the extent, diversity and role of monitoring. It shows developments related to the establishment of an OEL (in this case a TRK) value for a certain substance (wood dust), its significance / meaning for improvement of health and safety at enterprise level, and the complexity of the whole framework. The overwhelming majority of the data collected has its origin in studies performed by either the BG Holz or by the State authorities. Studies based on exposure measurements performed by

198 Beyond Limits Limits 198

employers as part of their duty to assess the exposure situation when dealing with dangerous substances are not accessible. There are two main reasons for this: -

The data are not publicly available. Labour inspectors have the right to examine them, but can only use them within the framework of the control and surveillance of the enterprise.

-

According to our interviews, another more fundamental reason for the lack of this kind of data is that only a minority of employers perform exposure measurements (subjectively estimated at about 5 per cent or less, based on the experience of labour inspection in one of the Lander).

Pinpoint actions. In 1987 the Gewerbeaufsicht Hessen272 performed one of the first 'pinpoint actions' on wood dust. The background was the new legal requirements and obligations for wood working and wood processing companies (as outlined above) and the resulting tasks for the State authorities, to supervise and control the new legislation. At that time, around 4500 wood working and wood processing companies with more than 40,000 employees were registered in Hessen, most of them belonging to SMEs. The aim of the pinpoint action was to evaluate: -

How many companies complied with the TRK value?

-

What was the exposure situation of the employees (which was considered to be too high already)?

-

What were the reasons for this exposure situation?

-

What was the state of the art in dust abatement technology and in how many companies was this technology level achieved?

-

What type of measures and strategies were necessary to improve the situation?

The pinpoint action ran over a period of two years. Out of the 4500 companies, a random sample of 400 enterprises were registered, of which 390 were visited and analysed with respect to the type of timber and dust abatement technologies used.

State Industrial Inspection of the Bundesland Hesse.

Germany 199 199 Germany

The results showed severe shortcomings in occupational safety in the companies under investigation:™ -

wood dust exposure measurements had been performed in only 3 per cent of the companies

-

32.7 per cent out of the 7257 wood working and wood processing machinery didn't have any dust abatement facilities at all274

-

10.6 per cent were only connected to a dust bag

-

56.2 per cent were connected to the central ventilation

With respect to the exposure situation of the employees, the following results were found: 20 per cent of all measured exposure values2'5 were above the TRK value of 5 mg/m3 (the limit value for existing plants). hi one in every ten workplaces the exposure measured was twice as high as the TRK value. Maximum values measured were 63.7 and 33.9 mg/m3 which corresponds to an excursion factor of 12.7 and 6.8 respectively. Serious exceeding of the TRK value was found at workplaces with hand sanding machines without any abatement technology, but other machines (sanding machines or saws) caused concern as well. Other findings included that a work area analysis according to the TRGS 402 had not been performed in any of the companies. Operating instructions did not exist and annual training of the workforce didnt take place. Suitable respirators were not available in any of the companies, hi nearly half of them, the exhaust air was re-directed to the workplaces, leading to an (avoidable) increase of the basic This is a selection of the results. The whole report is published by; Hessisches Sozialministerium undHessischeLandesanstaltfUr Umwelt, Abt, Arbettsschutz(1989). But these 32.7 per cent included machines which could not always connected to a any kind of dust abatement system like veneer machinery or power drills. The results are based on 600 samples, taken over a total period of 1200 hours out of which 111 representative average shift values could be derived.

200 Beyond Limits

exposure burden. Another (avoidable) contribution to the basic exposure burden connected with extreme exposure ceilings was 'achieved' by cleaning the work clothes, the tools, the machinery and the whole workplace with compressed air. There was only limited awareness amongst duty holders and workers of the cancer risk of wood dust. The state authorities concluded that better engineering controls for wood-dust (e.g. dust extraction/abatement systems with personal protection only as a last resort where compliance with TRK values could not be guaranteed) and an obligation on employers to follow a hierarchy of preventive controls including instruction and training were needed. They also required a higher awareness of their duties from employers, particularly their responsibility to monitor the working conditions through work place analyses (which includes an initial and subsequent control measurements) and optimum facilities to monitor dust emissions. In addition they recommended that when designing workplaces / buying machinery etc, the dust reducing potential of a tool / machine should be considered as important as its other technical specifications. Furthermore, it was concluded that state authorities need to ensure an efficient control of the (new) OHS legislation and they must - if necessary - enforce it with the legal instruments available. These findings probably reflected a position in wood-working and wood processing workplaces in Germany at the beginning of a process where everyone involved was confronted with a new situation: -

public authorities with new surveillance and enforcement tasks

-

employers with new legal obligations

-

workers with new (or at least now officially confirmed) evidence about health hazards.

Campaign of the Office for Labour Protection, Hamburg. In 1990 following the pinpoint action in Hessen, Hamburg's Office for Labour Protection decided to initiate a comprehensive action programme on wood dust covering all woodworking and wood processing activities in the area of Hamburg. A basic premise, also shared by many studies that followed, was the aim to achieve working conditions which - because of the dust extraction systems and other related technologies put in place - would guarantee the compliance with the current TRK value without having to perform regular measurements. The campaign was

Germany 201

intended to run until the end of 1995. However, it was confronted with criticism and opposition from its targets and many of their support organisations from its outset. Trade organisations like the Association for Wood and Plastics276 recommended its members did not co-operate. In addition, the Holz BG advised its members not to take part in such a study but to wait until the Holz BG had performed its own long term study on how best to transpose the requirements of the TRGS 553.277 All of this meant that the uptake of the campaign was not as extensive as it could have been and by 1996, the Office for Labour Protection managed to examine about half of the 500 wood working and wood processing companies in Hamburg and its environs. Nevertheless, the publicity the campaign produced inspired other Lander to initiate similar studies. The campaign was also a starting point for other activities at regional and national level (some of them are described further below), in most of which Hamburg's Office for Labour Protection278 was involved in a leading position as a result of experience gained in its own campaign. Model Guidance Document of the Committee of the Lander for Occupational Safety and Security Technique. In 1996, the Committee of the Lander for Occupational Safety and Security Techniques published a guidance document279 which aimed at helping entrepreneurs to fulfil their obligations resulting from the Ordinance on Hazardous Substances and the TRGS 553 'Wood dust', and at securing a common approach for the State authorities when executing the TRGS 553 in the Lander of the federal republic. The brochure is a detailed description of all aspects of preventive health and safety for wood dust. It is concerned to promote best practice and thereby to reduce regular surveillance by exposure A few days after the start of the campaign, the Office receive a copy of a special circular, which the sector Association for Wood and Plastics had sent to their members as a response to the action taken by the Office. In this circular it was recommended that the member companies should not fill out the questionnaire etc. for the time being because they would risk legal persecution if doing so. The Trade organisations finally agreed to support the project but this was more lip-service than anything else. In between, the classification of beech and oak wood dust as carcinogens was adopted, and the TRGS 553 was published - causing in its first edition - at least for some aspects - more problems than solutions. Represented by its Laboratory for Occupational Safety and Health, and in particular its head Prof. Dr. Wustefeld. Landerausschufi flir Arbeitsschutz und Sicherheitstechnik (1996).

202 Beyond Limits Limits 202

measurements to a minimum. It includes advice on how to calculate the amount of oak / beech wood used (because of the threshold of 10 per cent for more stringent health and safety provisions), how to design an operating instruction and how to organise a regular check of the abatement devices. Project of the BG Holz 'Transposition of the TRGS 553'.2S0 This was one example of several projects undertaken to help establish criteria under which the limit value could be guaranteed permanently and securely (thus making the necessity of monitoring superfluous). It was also the project that the BG Holz advised its members to engage with rather than the one being carried out by the Hamburg Office for Labour Protection (see above). It was undertaken between May 1994 and September 1996 and aimed to establish: -

Which workplaces and / or machines needed to be equipped with a dust extractor?

-

When exposure measurements according to the TRGS 553 could be dropped, because so-called dust-deficient areas could be shown to exist or because machinery could be put in the same category as certified machinery (i.e. those producing acceptably low dust levels)?

-

What type of dust collecting / dust extracting devices installed on existing machinery are proven to be successful in practice (thus allowing further control measures to be dropped if machines were thus equipped)?

-

What level of quality of extraction and separation of wood dust is needed to guarantee the TRK value at the workplace?

The project consisted of 48 companies - chosen randomly - of which 17 participated until the end. Initially it was found that the TRK value of 2 mg/m3 was exceeded in more than one third of all cases. For personal measurements, the excess was even higher with 72 per cent of the measurement values exceeded the TRK value. The main reason for these high values was non-existent, inefficient or out-dated dust abatement devices, in particular in areas where hand machines were used. By equipping machinery either with new or improved abatement devices and ventilation systems, it was shown that the average wood dust concentration could be reduced from 3.5 mg/m3 to around 1.0 mg/m3. Of the 39 per cent of the companies, exceeding the TRK value during the stocktaking

Holz-Berufsgenossenschaft (Hrsg) (1998).

Germany 203 203 Germany

exercise at the start of the project, only 9 per cent did so following intervention with recommended controls, (although personal measurements remained high with 41 per cent still above the TRK value of 2 mg/m3 and 11 per cent laid above the 5 mg/m3 value). The general conclusion was that if state of the art dust controls were used, the overwhelming majority of companies could achieve the established TRK value. Studies on wood dust exposure performed within European projects. The Holz BG has also been involved in projects of the European Union, aiming at developing exposure registers for hazardous substances in industrial enterprises of the woodworking industry. One of the recent studies was performed to assess wood dust exposure in selected companies with good abatement technologies (Poppe et al, 2002). The TRK value of 2 mg/m3 was exceeded in 27 per cent of the personal measurements, the European OEL of 5 mg/m3 was exceeded in 6 per cent of the personal measurements in companies involved in manufacture of boxtype furniture, frame construction, manufacture of solid wood furniture, manufacture of wooden articles, and saw mills. Another observation was that wood dust exposure in industrial companies is less than in handcrafting work working and wood processing companies, even if these are equipped with model wood dust reducing technologies. Several other studies were performed in order to evaluate and to document the state of the art either for specific workplaces and / or specific machinery. A range of situations are described in these studies, from joiners' workshops (Adolph et al 1997) where it was shown to be possible to achieve the TRK value of 2 mg/m3 in a cost-effective way by using the recommendations given in Model Guidance Document of the Lander, to surface treatment of parquet flooring where the use of personal protective equipment is recommended because of the difficulty in controlling dust levels in the process.2812a. Criteria developed in these studies help to determine under which working conditions the OEL might or might not be respected or eventually even 'guaranteed permanently and securely1. Other studies led to recommendations on integrated de-dusting facilities for hand-held electric tools (Georg era/1998). Studies performed to up-date the so-called 'negative list', Two studies have been undertaken explicitly to deliver data for the German Committee for Hazardous 281 282

Technical Rule for Hazardous Substances N* 420, Annex II, Staff- und verfahrensspezifische Kriterien - VSK.

204 Beyond Limits

Substances to have a sound basis for revising the 'negative list' of the TRGS 553 (Detering et al 1999, Detering et al 2000). This is the list, that includes those work areas and installation where the TRK value of 2 mg/m3 cannot be realised. Its revision was postponed several times283 but the final deadline for revision was set for 31 December 1999. After that date, only those work areas / installations, for which supporting data2M had been delivered would remain on the list. The results presented in the first (1999) study were based on measurements performed by: -

the BG Holz, most of them within the former mentioned project on the transposition of the TRGS 553

-

measuring facilities of the German Lander2"

-

the Laboratory for Occupational Safety and Health in Hamburg

-

the Research Institute on Hazardous Substances of the Mining Berufsgenossenschaft.

The study concluded that the TRK value of 2 mg/m3 could be achieved at various installations mentioned in the 'negative list', if they had state of the art equipment. But this would only be true for the short operating times normally found in handcrafting work activities, hi industrially run companies, operating times are normally longer, resulting in higher exposures during a shift. As a consequence, the study proposed a shortened 'negative list',286 but one that included the obligation to evaluate whether or not work at a certain machine is performed only seldom and for very short periods or permanently. In most cases when revising the 'negative list', the AGS followed the results of the 1999 study, except for some specific workplaces with manual wood working activities. This was mainly because of unavailability and / or quality of supporting data. In order to deliver the missing data, the Holz-BG together with the Laboratory for Occupational Safety and Health in Hamburg undertook a second project, (Detring et al 2000). One of its main conclusions was that in some of 283

Meaning t h e deleting of some of the work areas and / or installation from this list and as a result of that the application of the lower T R K value of 2 mg/m 3 instead of 5 m g / m 3 for these deleted work areas / installations.

284

Data supporting the allegation that the T R K value of 2 mg/m 3 can not b e realised.

285

Baden-Wurttemberg, Hamburg, Hessen, Niedersachsen. In particular all machines used in joineries were proposed to b e eliminated from the list.

286

Germany

205

these wood-working companies, the TRK value of 2 mg/m3 and sometimes even the 5 mg/m3 could not be achieved.

TOLUENE In this section we consider the second substance that is the focus of our detailed attention concerning the role of OELs in regulating chemical risks. We start with some general information concerning the nature of the hazards of toluene that have led to the setting of an OEL. This is followed by an outline of its use in the industries on which we have focussed and a presentation of some of the main sources of information on surveillance of compliance with exposure limits. Finally, we present some case-studies of policy and practice in selected companies whose personnel we interviewed in the course of our fieldwork. Hazards. In Germany287 toluene is regarded as a highly flammable substance with acute toxic effects that include disturbances of the central nervous system (CNS), minor irritation to the eyes and the airways and lung damage following aspiration. Chronic toxic effects are skin damage due to contact with the liquid and functional disturbances or damage to the CNS. A risk of reproductive-toxic action (impairment of reproductive capability and/or damage to the developing embryo or foetus) is suspected.288 There are also some indications of a fertility decrease in animal experiments, which have not been proven in epidemiological studies. It is therefore classified as toxic to reproduction, category 3. Despite some positive results in certain mutagenicity studies on persons occupationally exposed, no final assessment of this effect has yet been completed.289 Relevant legislation and OEL. Toluene received its first MAK value in 1958 (750 mg/m3 or 200 ppm). This value was reduced to 375 mg /m3or 100 ppm in 1985 and to 190 mg/m3 or 50 ppm in 1994, which is still the current MAK value for the

Gefahrstoffinformationssystem der Gewerblichen Berufsgenossenschaften (2002). Infertility is covered by the definition of the German MAK value (because the adverse health effects are directly linked to the worker) whereas teratogenic effects / developmental effects are not covered by the MAK definition (because these effects might occur in the possible offspring) (Rudiger 1999). Mutageneic effects are in principle not covered by the definition of the German MAK value (Rudiger 1999).

206 Beyond Limits

substance. The ceiling value is four times the MAK value.290. In 1991, a BAT value of 3.4 mg/1 toluene in blood was established, which was continuously reduced over the years to its current value of 1.0 mg/1 toluene in blood, which was established in 1997291. Because a significant amount of toluene can be absorbed via the skin, the contribution by skin absorption has to be taken into consideration when analysing the exposure situation at work places. Not exceeding the MAK value as such is therefore not a sufficient criterion to apply to exposure. Toluene is subject to classification and labelling requirements according to Directive 67/548/EEC. Next to the legislation on OELs and BATs, the requirements of the Ordinance on Hazardous Substances apply as well as various other regulations at national level dealing with flammable liquids,292 water pollution,293 air pollution,294 major hazards,295 storage and transport, protective equipment and ventilation. As was the case for wood dust, the Ordinance on Hazardous Substances in conjunction with the TRGS 402296 lays down how to determine and to assess the airborne concentration of dangerous substances in work areas and whether or not work areas can be exempted from exposure measurements297. This is the case 'when the limit value can be guaranteed securely and permanently' (see description in the previous section on wood dust).

2 291

Technical Rule for Hazardous Substances N° 900. Technical Rule for Hazardous Substances N ° 9 0 3 .

292

Verordnung

293

Einstufung wassergefahrdender Stoffe: W G K 2. Technische Anleitung zur Reinhaltung der Luft (TA Luft): Section 3.1.7m Substance Class

294

iiber brennbare

Fliissigkeiten

(VbF): Danger Class A l .

II, OEL0,lg/m3. 295 296 297

Council Directive 82/501/EEC. Technical Rule for Hazardous Substances N° 402. Notwithstanding the fact o n whether or not a work area is exempted from exposure measurements, other obligations of the employer according to the Ordinance of Hazardous Susbstances remain i n force like its obligation to use less hazardous substitutes if available, to respect the hierarchy of protective measures, to eqip every workplace with an operating instructions and to perform regular trainings for the workforce.

Germany 207

Occurrence and use.2"2" Toluene is used in general: -

as solvent for various natural and artificial resins

-

a solvent for illustration retrogravure printing paints

-

in the production of trinitrotoluene, benzene, cresole, phenole and various other products

-

in spays for various surface treatments (producing varnish and other surface covers).

In the construction industry it is used: -

as a solvent component of epoxy resins

-

in sealings of wooden surfaces (parquets etc.)

-

in wood glues and adhesives etc., PVC and other glues

-

as a de-stainer and solvent for special purposes.

In the metal industry it is used as a: -

constituent / component of varnish, dilutant of varnish, pre-paintings and glues, blend component for varnishes and artificial resins

-

component of various mixtures of carbon hydrates for cleaning and degreasing of surfaces etc.

-

component of cold cleaners

-

component of petrol

-

component of certain oils used in industry when punching holes etc. and oils for corrosion protection

-

component of epoxy resins

Industries using toluene: metal, printing and furniture making. hi our investigation of the role of OELs is the regulation of managing the risks associated with toluene we considered experiences in three industrial sectors: the metal industry, printing and furniture making.300 We have included several industries within our definition of the metal industry, the most important of which are: Gefahrstoffinformationssystem der Gewerblichen Berufsgenossenschaften (2002). Hauptverband der gewerblichen Berufsgenossenschaften (Hrsg.) (1999) See the previous section for a description of the furniture industry.

208 Beyond Limits

-

Machinery - The plant and machinery industry is Germany's largest industrial employer. It is dominated by small to medium-sized companies (70 per cent of about 6000 companies employ fewer than 100 people). In 2003, these 6,000 companies employed 886,000 people and the sector as such had a turnover of € 132 billion.301

-

Electrical engineering and electronics industry - The electrical engineering and electronics industry, with 819,000 employees, is the second largest industrial sector in Germany302.

Automobile Industry303 - With 772,673 employees (2003) is another important sector of the German economy. The printing and media industries304 constitute a much smaller sector of industry. In 2003, the turnover of the printing industry was EURO 16 billion and it employed 124,494 people. 95 per cent of companies have less than 100 employees. -

Surveillance of Occupational Exposure to Toluene. Toluene has been a wellknown hazardous substance since the 1950s. Adverse effects that are of most concern are the ones on the central nervous system and fertility, these are the basis for calculating the MAK and BAT values. Two major studies have produced extensive data on exposure of workers to toluene at the workplace in the last ten years: 1. Data collection within the framework of EU regulation 793/93 on existing substances305 2. A sector study performed in the rotogravure printing industry. 301

http://www.bmwa.bund.de/NavigationAVirtschaft/Branchenfokus/Industrie/maschinen-undanlagenbau.html.

302

http://www.bmwa.bund.de/NavigationAVirtschaft/Branchenfokus/Industrie/ elektroindustrie.html. http://www.bmwa.bund.de/NavigationAVirtschaft/Branchenfokus/Industrie/ automobilindustrie.html. http://www.bmwa.bund.de/NavigationAVirtschaft/Branchenfokus/Industrie/papier-und-

303

304

305

druckindustrie.html. Council Regulation (EEC) No 793/93.

Germany 209 Germany Data collection within the framework of EU Regulation 793/9. Regulation 793/93 obliges industry to submit all readily available data on 'High Production Volume Chemicals' (HPVCs).306 The basic principle of the Regulation is that the evaluation and control of hazardous chemicals must be based on an assessment of their actual risk to human health and the environment307 rather than solely on their intrinsic hazardous properties.308 This includes explicitly the obligation for the rapporteur to carry out an exposure assessment 'for whichever human populationgroup (i.e. workers, consumers or man exposed indirectly via the environment) is exposed or likely to be exposed to the substance.'309 Manufacturers and importers of chemicals, that are directly addressed by Regulation 793/93, normally don't have exposure data available for all intended used of a substance. This was the reason why in 1994 the BGen offered to supply data and information on branch specific uses of hazardous substances within the framework of Regulation 793/93 for the Minister of Labour and Social Order. A special working group on 'Existing Substances', chaired by the BG of the chemical industry was established310, using the data of the BIA311 database MEGA312 for describing the exposure situation at shop floor level. It developed uniform criteria for assessing the exposure situation at the work place. Until 1999 exposure data on 44 substances including toluene were supplied. 'Existing Chemicals' - 'Existing Chemicals' are those substances which were deemed to be on the European Market before September 18, 1981 and are listed in the EINECS inventory (European Inventory of Existing Commercial Chemical Substances) which were expected to be produced in or imported to the European Union with a tonnage exceeding 1,000 tonnes/year per producer or importer. The risk assessment principles for Existing Substances are laid down in Commission Regulation (EC) No. 1488/94. Risk assessment is based on hazard and exposure information; and a comparison between a predicted no effect level (concentration) with a predicted exposure level (concentration). Article 4 of Regulation 1488/94. Berufsgenossenschaftlicher Arbeitskreis Altstoffe - BGAA. BG-Institute for Occupational Safety. Mefidaten zur Exposition von Gefahrstojfen am Arbeitsplatz - Measuring Data on Exposure to Hazardous Substances at the Workplace / the BG perform about 60.000 measurements of hazardous substances each year in around 4.000 enterprises. The results, the framework conditions under which they were received and data about the enterprise as such are stored in the database MEGA / MEGA contains data of nearly 30 years of measurements.

210 Beyond Limits

Figure 5.2 represents the highly aggregated data for toluene (shift average values, 95 per cent values313) published by the umbrella organisation of the Bgen (Bock et al 1999).

Figure 5.2 Aggregated Data for Toulene 600

500

• 95%-Value 95%- Value

mg/m3

400

300

200

100

0 11

22

33

44

-H55

66

77

88

99

10 10

11 11

12 12

13 13

14 14

15 15

16

Type of work / branches

313

The 95 per cent value represents the mg/m3 value which is achieved by 95 per cent of all measurements (95 per cent of all measurements lay below, 5 per cent are equal or above the 95 per cent value).

Germany 211 Figure 5.3 Exposure measurements of Toluene (based on 7013 measurements from about 2050 enterprises between 1991 and 1995) 1

Manufacturing of preparations

2 3 4

Cleaning, de-greasing (mechanically) Cleaning, de-greasing (by hand) Wood working and wood processing

5

Upholstered furniture manufacturing

6

Surface covering work

7

Painting, rolling (metal processing)

8

Painting, rolling (construction industry)

9 Paint spraying (metal processing, electronic techniques) 10 Paint spraying (construction branch) 11 Paint spraying (wood processing) 12 Mechanical surface treatment (metal processing, electronic techniques) 13 Mechanical surface treatment (wood processing) 14 Screen painting, by hand (construction industry) 15 Screen painting, by hand (ceramic and glass industry, printing industry) 16 Printing (Illustration rotogravure printing)

Branch study performed in the rotogravure printing industry. This is probably the most comprehensive study ever performed for a single substance and a special branch. It was undertaken because of new evidence concerning: -

potential changes of cognitive functions and the sense of hearing at a level of exposure below the MAK value of 50 ppm

-

changes of memory functions for a large sample of German rotogravure workers at the current level of exposure below 50 ppm (Seeber et al 2002).

The rotogravure printing industry is unique with respect to the use of pure toluene,31* therefore offering research conditions not found anywhere else at workplaces. In January 2002, after almost ten years of research, the Institution for statutory accident insurance and prevention in the printing and paper processing industry presented the final report of their field study on 'Toluene in the rotogravure industry'. This report completes the most comprehensive study ever performed315 to assess possible adverse health effects of toluene exposure (Neubertefa/2001).

As specified by DIN Standard 16513. At least in Germany,

212 Beyond Limits

Altogether, complete data sets, i.e. on both ambient air as well as blood toluene levels, were obtained from 1244 male and 124 female participants of the rotogravure industry with different degrees of toluene exposure'. Since 1993 actual toluene exposure was measured on nearly 5,000 references in 15 rotogravure plants. Exposure data for the period since 1960 could be determined from the records available in the various printing plants. While the toluene concentration amounted to 140 ppm (parts per million) in 1970, it came down to an average of only 25 ppm at the time of the long-term study (1996-2001).316 Besides providing some information on the exposure at various work-areas under occupational conditions, the correlation between a time-weighted average of the ambient air concentration with the corresponding blood toluene levels were analysed (Neubert et al 2001). Based on these results, the Institution concluded that there was no evidence for health hazards from toluene exposure for workers in the rotogravure industry and that the limit values applicable today were appropriate. This view was also shared by the employers' representatives interviewed during our study. Other studies in the metal industry. Compared with the situation in the printing industry, toluene exposure in the metal industry is normally not a single-substance exposure situation but characterised by a mixed exposure. Toluene is normally an ingredient of a more complex solvent, mainly used for treating surfaces (either by cleaning them or by adding varnish or other coats) and often users are not aware that toluene is part of the product they are using. Data on toluene exposure is normally only available in the broader context of that for organic solvents generally. One quite detailed study has been performed by the machinery and metal BG and the Norddeutsche Metall BG within the scope of their general surveillance tasks. The MASCH-BG317 is one of five Berufsgenossenschaften in which employees and companies of the German metal industry are insured, m 2002, it represented around 1.2 million employees in just over 40,000 enterprises in the machinery construction and metal industry. Since 1979 it has had a special unit dealing with

Since 1994 an occupational exposure limit of 50 ppm is valid. Maschinenbau und Metall Berufsgenossenschaft - Machinery construction and metal Berufsgenossenschaft.

Germany 213 213 Germany

dangerous substances, (something that doesn't exist in any other BG) which performs measurements within the companies insured by the BG. It also deals with occupational diseases linked to dangerous substances, therefore covering the whole area of exposure to and compensation of occupational diseases linked to dangerous substances. Since 1986, it has carried out about 2,500 measurements for all uses of toluene. The number appears to be quite low, but according to the BG, this reflects the limited importance of toluene in the companies it insured. As a pure substance it is hardly use at all. If it is used, it is in mixtures and then only present in very low proportions. It has been replaced by non-aromatic substances in many of the applications in which it was used previously, for example as a solvent or for cleaning purposes. If such products still contain toluene, it is in such a low concentration, that the risk of exceeding the limit value is minute. One example where it is still used is in glue, another is in varnishing / painting surfaces of cars and other products. A combination of external pressure (legislation, image etc.), developments in technology, higher perception of risks in general for certain substances, availability of alternatives have all led to the reduction of its use. Thus, according to the data the BG has collected, between 3.4 and 0.2 per cent of all measurements obtained results above the limit value of 190 mg/m3, while between 64.5 and 92.3 per cent were below 0.1 of the limit value. Reasons why measurements are performed by the BG vary. The technical surveillance officer may suspect that the limit value is being exceeded in a certain company. But in general measurement is made more in the framework of targeted campaigns or awareness raising programmemes or if data is needed, such as in the European programme for existing substances described above. Measurement for toluene are of course then performed only when an indication exists that toluene is present at the workplace, meaning surveillance authorities (as well as employers) depend on the information given in safety data sheets, for example. It is not the task of the BGen to act on behalf of the owner of a company with respect to its general obligation to secure working conditions below the limit value. But data collected and published as a result of a targeted campaign can be used by every employer to prove that they are respecting the limit value by establishing comparable working conditions. The establishment of comparable working conditions is also used by the surveillance authorities to assume that limit values are respected. For example authorised repairers of Volkswagen have to fulfil strict requirements with respect to machinery and tools used to repair the

214 Beyond Limits

cars because they would otherwise damage the image of Volkswagen. So if the standards foreseen by Volkswagen are judged by the surveillance authorities to be sufficient to secure the limit value, every appointed dealer 'benefits' to a certain degree from this assumption. Finally, surveillance results also depend on the technical capacity of the inspector in charge. The inspectors of the BGen receive a broad range of training, but people differ in their attitude and workplace experience. Company case studies on toluene in the metal sector. All in all, toluene is not a 'hot topic' in the metal sector. This was reflected in the interviews with representatives of three companies in the sector including those with : -

the head of the chemical safety department of the Volkswagen AG plant in Kassel-Baunatal (see Box 5.1) a works council member of the Bosch-Siemens Haushaltsgerate Werk in Berlin (see Box 5.2) the head of the environment and safety department of the Drehgestellwerk (bogies production) of Bombardier Transportation in Vetschau (see Box 5.3).

The viewpoints collected during these interviews indicate the way toluene exposure is monitored and also how changes in legislation have affected its use in the industry. In the example of Volkswagen AG in Box 1, the impact of health and environmental awareness at corporate level is strongly evident in the substitution policies developed and applied throughout the company. It is also a powerful example of the way in which major economic players can affect the behaviour of their dependents in the supply chain, as is illustrated by its requirements on its suppliers for health and safety information. The second example is a further illustration of how substitution has dominated the management strategies for chemicals such as toluene and also provides a good example of the engagement of workers' representatives in decision-making on chemical risks, including their relations with the surveillance authorities and their engagement with the activities of the latter. The third example suggests that the reduction in the use of toluene is not restricted to successful West German plants but is also the case in at least some plants in the former FDR.

Germany 215 Germany

Box 5.1 Volkswagen AG, Kassel-Baunatal The VW plant in Kassel is the second largest VW plant, employing over 16,000 people and the biggest employer in Northern Hesse. It is a manufacturing plant mainly for individual component parts of engines and gearboxes and body panels, as well as being the largest engine and gearbox reconditioning plant in the world. It also comprises the entire parts sales and distribution division for Volkswagen AG worldwide. For the Volkswagen AG, the management of dangerous substances is part of its corporate identity and integrated in its environmental policy. Being a global player with respect to its plants and products, VW is also actively involved in events and groups at global level. As a consequence of this overall policy, the substitution of dangerous substances by less dangerous ones does not only follow the legal requirements but is considered to be one of the main tools to achieve very high standards in health and safety working conditions as well as in environmental performance. Uniform OSH and environmental minimum standards and procedures are laid down for all plants across the group. About 80 per cent of all the dangerous substances used in the enterprise are found in the group of so-called process chemicals (for example adhesives, varnishing materials, cleaning agents). A special procedural instruction for the introduction of these process agents foresees a release obligation. This means that before it comes to a final serial application of these materials within the production, they go through several stages of a prescribed examination programme. If, at the end of the process, the substance has been proven to be suitable, it has also been assessed with regard to its labelling requirements and its safety-chemical check. A very important part of this procedure is the evaluation for possible less hazardous substitutes and their documentation in a computer-based database. Each external supplier of dangerous materials has to reveal the composition of its product, otherwise it is not even considered for the use in any VW plant. Volkswagen uses toluene in very few preparations (beside the sector for surface treatment with varnish). VW is also recognised as a measuring point according to the Ordinance on Hazardous Substances, which means it is entitled to perform its OEL surveillance by its own personnel and equipment etc. This does not mean that VW can for example only pretend to follow the legal obligations based on the measurements performed by its own body. The measurement point is checked regularly by the state authorities and has to fulfil high standards in order to be considered as such.

216 216 Beyond Beyond Limits Limits

Box 5.2 Bosch Siemens Hausgerate GmbH (BSHG), Berlin The company produces a wide range of electrical household appliances like freezers, washing machines and cookers. It is an internationally operating group, encompassing 42 factories in 15 countries in Europe, the USA, Latin America and Asia. In 2001 the BSHG Group made a turnover of more than €6 billion and employed about 35,000 worldwide. The representative of the works council we interviewed had tried hard to find some evidence for toluene use within its company. Like VW, the BSHG has a whole section dealing exclusively with environmental and health and safety standards. Even with the help of one representative of this OSH and ENV section, we only could find one product used in the company that contained toluene. Here, as in so many other companies of the metal sector, toluene has been successfully substituted, in order to avoid extensive and expensive legal obligations and because of the availability of suitable alternatives. What was important in BSHG was the experience of the works council of being involved in the management of dangerous substances within its plant. They are consulted in the production of official reports from surveillance authorities on dangerous substances; they are also always informed in advance if somebody from a surveillance authority is going to visit the company and a member of the work council is part of the group that joins the inspector during his visit. However, for the works council, exposure to dangerous substances was of minor importance compared with other health and safety problems, which is in line with the results of the other interviews.

Germany 217 217 Germany

Box 5.3 Bombardier Transportation, Vetschau Bombardier Inc. is a Canadian corporation engaged in design, development, manufacturing and marketing activities in the field of rail transportation equipment, aerospace and recreation products. The Montreal-based corporation employs 47,000 people world-wide. Bombardier Transportation is specialised in the design, manufacture and distribution of products for the passenger rail market and offers, amongst others, a wide-range of urban, suburban and intercity vehicles. The plant in Vetschau (former GDR) has 110 employees, produces bogies for various coaches and driving trailers and illustrates well the transitional economic ups and downs, companies in former Eastern Germany experienced after re-unification. Before, during and after the interview in July 2002, the plant (which has a more than 140 year history) was regularly in the news because of the threat of closure. Health and safety is part of the environmental policy of the company. Here, as in the other two companies described, toluene is no longer used. Besides the factors mentioned during the interviews with VW and BSHG, for the OSH representative in Vetschau the storage requirements for toluene or toluene containing products were an important factor in the decision not to use the substance or related products any longer.

DISCUSSION: THE ROLE OF O E L S IN MONITORING COMPLIANCE WITH REQUIREMENTS TO MANAGE THE USE OF CHEMICALS SAFELY OELs have a significant niche in the overall system for regulating OHS in Germany. There are several possible reasons for this. To begin with there is a substantial history of independent national activity in setting OELs (at least in the former West Germany). As a result the structures and processes by which this is achieved are a well established part of the fabric of the regulatory system. They and the OELs they generate are clearly valued by the social, professional and political actors at this level. Additionally it is no coincidence that several of the sectors of industry with which the development and use of OELs are perhaps best associated, such as the chemical and manufacturing industries for example, are prominent elements of the industrial profile of the country. Moreover, while small enterprises are an important part of the economy, large enterprises have also been

218 Beyond Limits

much in evidence in sectors in which substances with OELs are in use. It is such enterprises that support the employment of the OHS specialists who can contribute to the development of an infrastructure and culture that would help to support the role of OELs in technical risk assessment in these sectors. More influential than all of this however, is perhaps the tradition of the wider regulation of health and safety, which, as we have pointed out, has been dominated by a technical approach to the subject, and a plethora of technical rules. It is this tradition that has supported a strong role in monitoring and surveillance for the institutions of the regulatory system whether they are part of the social insurance infrastructure or that of the Bundeslander, However, despite the relatively developed profile of OELs and their surveillance within professional approaches to OHS and arguably in the regulatory tradition, their use and the understanding of their role is not ubiquitous in workplaces throughout industry. Nor is it clear that the published or available number of measurements undertaken is necessarily a good indicator whether or not the system of OELs in Germany 'works' in terms of improving the systematic management of health and safety or its outcomes. Indeed, respondents in the present study have argued that monitoring airborne exposure to chemical substances with OELs is not even particularly significant in 'normal' approaches to managing the risks of hazardous chemicals in more than a (albeit substantial) minority of workplaces where such chemicals are used. Indeed, the quality of surveillance/enforcement is not necessarily linked to the number of measurements performed (even though there is a huge amount of measurement data). Quite the contrary, arguably, if there were numerous reports about measurements, then it would be a serious indicator that the whole system was failing. In this final section, we review our findings and consider some of the issues surrounding the measurement of compliance with OELs for wood-dust and toluene and its role in promoting systematic approaches to managing occupational health and safety within the German regulatory system. Monitoring the degree of compliance with OELs for wood-dust and toluene. In the case of both toluene and wood-dust there is considerable experience of monitoring airborne exposures by or on behalf of the authorities for inspection and control. However, the two substances are illustrative of rather different kinds of OHS management problems. Toluene, which was once in widespread use in a large range of industrial sectors is now less used than in the past and (at least as a pure substance) not subject to the same degree of concern about possible

Germany 219

workplace air contamination, because as discussed below, a combination of considerations derived from occupational health and safety concerns, cost factors and social/regulatory/political pressures mean that it has been largely replaced by alternative products or it is used under conditions in which possible environmental exposures are much reduced by the technology employed as is illustrated by the case of rotogravure printing, where it is still commonly used as a production aid for the printing of mass media products such as magazines and catalogues. As illustrated in Box 5.4, this example of continued use provides a clear illustration of how technology in conjunction with economic considerations has given rise to improvements in control that, in turn, reduce the need for widespread airborne monitoring. Toluene in the printing industry is a good example of how diverging interests have considerably improved the health and safety situation of workers. Together with the facts that toluene is the only solvent used in the rotogravure printing process and epidemiological data on its health effects was widely available and not really disputed, a situation has developed in which: -

legal requirements have been tightened continuously over the years, resulting for example in an OEL of 50 ppm, at which scientific research is struggling to prove any adverse effects to health

-

tightening legal requirements, and in particular, economic considerations, created pressure to improve technology, thus allowing closed systems and recovery of the non-substitutable and expensive solvent

-

environmental considerations, not just ones influencing recovering toluene as a raw material, but also attempts for energy savings or reduction of solvent emission in the final product added further pressure to reduce toluene concentration in the ambient air318

A further (largely cost related) reason for discontinuing the use of toluene are legal requirements concerning its storage319 and the requirements to keep it apart

Environmental protection standards - like reducing solvent emission and diminishing the residual proportion of solvent in print products - are a pre-condition for a company wishing to be recognised as environmentally friendly. This is true for all industries using toluene. Toluene belongs to the storage class A3 - flammable, liquid substances. Only substances belonging to the same class should be stored together.

220 Beyond Limits Limits 220 from other materials used in a company.320 In addition, special requirements have to be met when handling and using the pure substance or products containing toluene at a certain percentage.321 These are all cost-intensive factors and if a company can reduce these costs, it will do so. In all these cases of strategic decision-making concerning the use of a hazardous substance monitoring compliance with the OEL it has been of relatively limited significance in determining outcomes. Box 5.4 Toluene in rotogravure printing 'Toluene cannot be substituted in the rotogravure printing industry' - was a statement heard from all interviewees in the sector. So if it cannot be substituted, and if epidemiological data indicates adverse health effects, then indusuy has only one possibility: to reduce the exposure situation by using closed systems and/or reducing the number of people exposed: 'Automated work processes are the striking feature present in all areas of this printing plant for fast, cost-saving production of printed products with a minimum use of labour.' Another aspect in times of growing economic pressure is the price of the raw material, a material that must fulfil strict standards, since toluene used in rotogravure printing is the only solvent used in the process and is required to be pure as specified by DIN standard 16513. Therefore considerable efforts have been made in the industry to recover toluene by using enclosed systems with solvent recovery facilities.397 As a result, the machines used in rotogravure printing are often designed to work fully automatically. The entire press installation is monitored and controlled from a central master control console using integrated process control systems. Only a limited number of people are needed to watch the monitors, sitting in sealed chambers in the middle of huge production halls in which every day bigger, more complex and more efficient machinery is installed.398 Only in cases where something goes wrong, might workers be exposed to high concentrations of toluene.

Because of its chemical-physical properties, toluene is not allowed to be stored together with substances with which dangerous chemical reactions are possible. In particular sufficient ventilation, explosion-proof electrical equipment and lighting; buildup of electrostatic charges (e.g., by grounding) has to be prevented etc. etc.

Germany 221

The full range of the potential health effects of wood-dust have been recognised for a shorter time than for toluene. Exposure to wood-dust is a problem that is confined to fewer industries, than was the historical case for toluene. However, unlike toluene, there is no obvious declining trend in such exposure and cost considerations far from aiding the reduction of airborne contamination are probably a powerful factor in maintaining it. Thus, exposure in wood-processing and furniture manufacture is often a problem of small enterprises that cannot afford the technology that would help to reduce it to levels within the OEL. As is common amongst such companies, the structures of vulnerability with which they are associated also mean that owner/managers often have neither the will or capacity to perceive the need for, or advantages of such controls. The problems of the sector are recognised by the regulatory authorities and a system is in place to encourage gradual improvements (for example, the so-called negative list, pinpoint actions etc.). As a result, there have been numerous activities since 1987 that have involved monitoring wood-dust exposure in relation to its OEL (either by the BGen or by the State authorities at different levels). Despite this, it is evident that the TRK value for wood dust is still often exceeded and many of the requirements of the basic legislation (the THRG 553 and the Ordinance of Hazardous Substances) are not transposed at company level. There is evidence that projects performed by either the BGen or the State authorities to design and establish model work places have achieved their intended trigger-down effect. But some companies continue to ignore legal requirements. While it is probably the case that overall there has been an improved consciousness and awareness amongst employers and employees of both the legal requirements and the health hazards of wood-dust (and that both the processes of setting and applying OELs may have played some role here), this doesn't necessarily lead to widespread application of initiatives started at enterprise level to improve the situation. This is particularly true for very small and small companies, where surveillance by labour inspectors is low and independent worker organisation is seldom present. Bigger companies normally face a higher frequency of labour inspections as well as a greater presence of works councils both helpful pre-conditions to 'convince' entrepreneurs to follow their legal obligations.

222 Beyond Limits

The means of achieving compliance with OELs, The starting point in the German system seems to be the parallel assumptions that: -

Measuring OELs is not necessary as long as surveillance authorities come to the conclusion that, according to the state of the art in technology foreseen for a certain sector/workplace, OELs are supposed to be respected.

— OELs are not respected in many (in particular small and medium sized) enterprises, but this is not because the surveillance/monitoring system as such has failed but rather that within the more general policy system of allocating resources for this type of work it is not regarded as a priority. The major tool for achieving compliance is the use of improved technology, in the case of toluene this has meant substitution and closed/recovery systems and in the case of wood-dust, the advocacy of the use of abatement systems and other dust reduction facilities. Here in particular big improvements have taken place, at least with respect to the availability of the technology needed. But once again the connection between monitoring compliance with the OEL in influencing these improvements is tenuous. Because everybody is more or less aware of the fact that wood dust exposure measurements are very seldom performed by employers even if it is their duty - the main emphasise of the regulatory authorities and other professional agents of the OHS system322 is on other strategies, like designing model work places which guarantee the compliance with the TRK value by using recognised abatement and dust reduction facilities with well established technical requirements for flow velocity etc. This is a big advantage for both employers and labour inspectors, because employers no longer need to measure and labour inspectors only have to look if certain machines are present and are working in the way they should. Measurement therefore becomes an exceptional requirement rather than a normal expectation. This is not only true for wood dust (and for toluene) but is a general approach in the German system of managing risks related to hazardous substances. As such, OELs have an important value in determining

The German OHS system has a highly developed and statutory role for occupational health physicians and safety engineers (see Popma et al 2002, Schaapman 2002, also Vogel 1993 and Walters 1996). While they are not in strong evidence in the wood-dust generating industries (because their presence is related to workplace size), the professional ethos overall will make a powerful contribution to defining the principles and priorities of prevention in relation to risks of wood-dust control.

Germany 223

the specification standards for machines, but a reduced importance as reference points for routine airborne monitoring - because the need for such monitoring is itself much reduced in such circumstances. The role of OELs in systematic approaches to occupational health and safety management. The logic of the above paragraph may be widely accepted but not necessarily implemented, since the availability of a certain technology is not necessarily a reason for a company to buy it. In the case of wood-dust generating industries the alleged major obstacle is cost, even if - according to the data published by the authorities - low-priced solutions seem to be available at least for certain applications. This is somewhat in contrast with toluene in the metal and printing industries where as we have seen, the cost argument seems to have combined with other pressures to create reasons for using the technology rather than rejecting it. While the overall direction of the system seems to be positive, the levels of surveillance of airborne exposures to hazardous substances in relation to their OELs is also a consequence of the dual system of State and BG inspection and control. It is especially evident from the various approaches to monitoring compliance with OELs for wood-dust described earlier, that this has often led to rivalry and competition instead of a concerted action between agencies, and to legal requirements which were not free of contradictions and created loopholes for those who were looking for them. Transitional periods for old and existing machinery and unclear requirements for workplaces where old and new machinery were used together323 probably contributed to a perception, at least in some companies, that there was no hurry and in particular no unified system to improve the situation. Taking into account the fact that many surveillance authorities assess workplaces based on their experience but also - and this is an even more important point - on evidence of working conditions, work places, the use of approved standard machinery, ventilation systems, reported cases of occupational diseases within a company etc., measurements of airborne hazardous substances in relation to OELs might in many cases not be necessary. That doesn't mean that the surveillance authorities believe there are no OEL related problems at German workplaces, but that there may be many other factors that are likely to influence the frequency of measurements.

At least at the beginning of the wood dust legislation.

224 Beyond Limits

With respect to the establishment of health and safety management systems in general and OELs as one part of the surveillance tools, there was widespread acknowledgement in the interviews we conducted that, the importance of advances in technology and substitution notwithstanding, these systems are well developed and in place in large companies but less so in small ones. However, it would seem clear that in Germany, OELs are not the driving force in promoting and improving health and safety at work. They play a relevant role in a complex system, but probably more as a measurable indicator in cases where something is going wrong rather than an active tool to enforce a higher OSH standard at the workplaces. They are nevertheless very useful, if only because there is no other comparable good indicator with which to audit this aspect of risk management. In big companies, they are part of OSH and/or environmental management systems for a variety of reasons (including their public image, public awareness, corporate identity, reduced costs of sickness absence, reduced costs in general etc.), of which improving the health and safety situation for the workforce is only one. One might also risk the thesis that the large scale devotion of regulatory authority resources to focussing on their surveillance may be counter-productive (with respect to health and safety) because in those small and medium sized companies, which employ most of the people in Germany (as in the rest of Europe), OELs are least known, understood or respected and it is these companies (which are arguably most in need of guidance and regulation) that are largely beyond the reach of the surveillance authorities. Clearly, it is a political decision not to allocate resources to undertake such widespread surveillance of monitoring that would be required to embrace small enterprises anything like fully either by the state authorities or the BGen. Allowing for this constraint the German surveillance and monitoring authorities have nevertheless managed to establish a sophisticated system that improves the existing situation without performing extensive expensive OEL measurements. It would seem therefore that they are going in a useful direction - perhaps not as fast as would be ideal and certainly not without struggles. Despite the problems, the system does seem to offer an important example of the means with which OHS authorities with limited resources for surveillance can usefully construct a complex of regulatory, economic and technological push-pull levers to improve chemical risk management in many workplaces. If recent changes in the regulatory system are examined against this background they will be seen to be largely in keeping with the logic outlined above. In the new system, greater attention will be paid to managing risks from known

Germany 225

hazardous substance rather than developing requirements that apply to all substances. This means that in future only exposure to dangerous chemicals or mixtures will be evaluated. In addition the introduction of a new limit value system is based on a risk-based approach that in combination with the so called 'traffic light system' gives the basis for a simplified approach to control that can be easily understood and generally applied across all enterprises using chemicals. In so doing it goes some way to meet the criticism of the limited effectiveness of the previous system at addressing the situation in small enterprises. While policy on the role of OELs within approaches to regulating chemical risks has featured some very different aspects in Germany compared with other countries, the trajectory of current policies can be seen to be moving in broadly the same kind of direction to that described previously in the UK. In addition as we shall see in the final chapter there are further parallels with developments in other northern European countries and these in turn are significant factors to take into account when trying to understand the notions behind the current reforms of regulatory policy on chemical risks at the level of the European Union.

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227

GREECE

INTRODUCTION In this chapter we outline the role of OELs in regulatory strategies on managing chemical risks in Greece. We consider practices in relation to the two substances that have been a particular focus of the study as a whole - toluene and wood-dust - in the three sectors in which their occurrence is most common. But we also address the use of OELs in regulating risk management in relation to hazardous substances more generally. According to the Third European Survey on Working Conditions (European Foundation 2001), nearly one third of Greek workers felt they were breathing in vapours, fumes, dust or dangerous substances for more than half their working time. Some 15 per cent of Greek workers suggested that they experienced such exposure for the whole of their working time. These percentages were considerably higher than those found amongst workers in any other of the EU 15 member states that comprised the Community at the time the survey was undertaken. Higher proportions of workers in Greece also reported handling dangerous products or substances than in any other country in the same survey. Other survey results within Greece itself paint a similar picture. For example, in a survey of 2,809 workers in Athens of those working in industry 45 per cent thought they were exposed to fumes, 50 per cent to dust and 29 per cent to toxic substances (Athens Labour Centre 1998). Despite the seriousness of this perceived problem of workers' exposure to hazardous substances, the extent to which measures to regulate the management of risks from

228 Beyond Limits hazardous substances in Greek workplaces have been developed to address it is relatively limited. It is also clear that, with the exception of a few large enterprises in the oil and oil refining business and the shipbuilding sector, the perception by employers and managers of OELs as tools for risk management in Greek industry remains minimal (Karageorgiou et al, 2003: 309). This is confirmed by a recent survey of the application of EU requirements on chemical hazards in the wide range of workplaces in Greece in which hazardous substances are in use (Bikos and Scarlatos 2003). The authors of the survey found that sectors in which there was significant use of hazardous chemicals were characterised by their excessive fragmentation, small size of enterprises and lack of investment in health and safety, with few managers with any relevant training and a tendency of owners and managers to blame market pressures for failure to take fairly obvious actions that would promote the safe use of hazardous substances. Limited perceptions of the nature of chemical risks, the historical underdevelopment of the national infrastructure for their regulation and control and the structure and organisation of the sectors in which the use of hazardous chemicals is common therefore all pose major challenges in Greece. However, such challenges are not entirely surprising. They are all aspects of the cultural and infrastructure! features of work environment regulation that are generally found in smaller and weaker market economies in Europe. In the case of Greece they have been the subject of several previous accounts.324 Indeed a primary reason for including Greece in the study was to examine the role of OELs in regulating risk management of hazardous substances in smaller southern European member states and to discover whether there were different approaches to their use in these countries. Insights into such approaches may also be of value in helping to meet some of the challenges posed by the new entrants to the expanded Community. We therefore identify and discuss the nature of the task confronting the effective regulation of risk management of hazardous substances in Greece and especially for the furtherance of the role of OELs in this process and its implications for inspection and control.

See for example the PIACT report to the Greek Government in the 1970s (ILQ 1978) and more recently, Spyropoulous 2000 and Walters (ed) 2002.

Greece 229 Greece THE REGULATORY INFRASTRUCTURE Since joining the European Community in 1981 successive Greek governments have striven to adopt 'European' approaches to economic and social regulation, including health and safety. However, the country's long history of economic weakness, limited provision for public services for health and social welfare, poor infrastructural support for regulation, political instability and confrontational industrial relations have presented many challenges to this process. The Health and Safety at Work Act 1568/85, was the first attempt at modern health and safety legislation was which contained the general health and safety duties of employers, provisions for worker representation and requirements for employers in larger enterprises to appoint occupational health and safety professionals to advise them on carrying out their responsibilities.325 Article 26 of Chapter V (echoing Dir.80/1107/EEC) obliges the employer to take measures to avoid or minimize the exposure of workers to hazardous agents, wherever this is practicable. In all events the level of exposure must be lower that the level defined as the 'exposure limit value'. Despite these provisions there is little evidence to show that following their introduction any significant change took place in arrangements for the health and safety of the vast majority of Greek workers. This was mainly because their application was severely restricted to workplaces above minimum sizes in which only a minority of the working population was employed (Walters 2001:197-202). It was also because there was a shortage of qualified OHS professionals to provide the necessary support capacity even for the restricted number of workplaces covered.336 It was not until the adoption of the Framework Directive 89/391, which was transposed by Presidential Decree327 17/96 in

Prior to this the main legislation on health and safety was contained in the 1934 Presidential Decree which was prescriptive legislation in a similar tradition similar to the UK. Factories Acts. Curiously, it had quite strong requirements on safety in relation to chemical substances including measures on classification and packaging of dangerous substances as well as special provisions on the removal of dusts and fumes. Indeed, in the years following the Act, there were so few professionally qualified occupational physicians that the state was forced to accept qualifications in other branches of medicine such as thorasic and cardiac medicine as their equivalent in order that employers who were obliged to do so could employ a physician to advise on occupational health. While a law is discussed and voted in Parliament, a Presidential Decree is simply signed by a Minister and approved by the President of the Republic. It nevertheless has the force of law.

230 Beyond Limits 1996, that an infrastructure in which the regulation of systematic health and safety management has become a more feasible objective began to take shape. Following this development many of the features of modem process regulation for health and safety could be seen to be emerging. In particular, the introduction of Presidential Decree 95/99 on External (EXYPP) and Internal (ESYPP) Preventive Services helped to make the provisions of the Law 1568 on occupational physicians and safety engineers a more workable reality. Under the PD95/99 before any EXYPP can operate it must be licensed to ensure it has the technical and personnel capacity to undertake prevention services, including a safety engineer and occupational physician as well as equipment for monitoring the working environment. The licensed EXYPP/ESYPP may undertake various tasks on behalf of employers including risk assessment (in accordance with PD17/96) and monitoring physical, chemical and biological agents at the workplace. The provisions have stimulated an emerging market for EXYPP organisations. In 2004 there were 23 established, nearly all of which had been set up within the previous four years.328 The Ministry of Employment and Social Protection (formerly the Ministry of Labour) is the main controlling body for the work environment in all work activities, public and private. In December 2000 a new corps of Labour Inspectors was established - Soma Epitheorisis Ergasiss (SEPE) - which was better staffed and equipped than the previous Labour Inspectorate, and organised centrally and regionally, rather than devolved to local authorities as had been the case previously. It constitutes a discrete Labour Inspectorate, with two branches; one for safety inspection and the other for the enforcement of more general labour law requirements. In order to implement this major 'administrative re-engineering' the Government: -

quadrupled the manpower of SEPE by recruiting new staff (over 360 new inspectors) provided a substantial budget for upgrading its material resources (measurement equipment, vehicles, computers, etc.).

The morale of labour inspectors improved, resulting in their being able to send a strong signal to recalcitrant employers that they must take their obligations seriously. The Labour Inspectorate central service is made up of: -

the office of the special secretary who heads this service According to sources at the General Directorate of Working Conditions, Ministry of Employment and Social Protection.

Greece 231 -

the department of Special Inspectors responsible for the internal monitoring of the service the planning and coordination division the administrative and technical support division.

The regional services are organised in line with the division of the country into regions and prefectures, and include: -

-

regional social inspection divisions, under which fall 76 local social inspection departments (mainly at the prefectural level) seven Occupational Risk Prevention Centres with sections on work environment measurements, on the divisional level, with interregional competency, under which fall 31 local departments of technical and sanitary labour inspection (at the prefectural level) For the Attica region in particular, where a large number of workers and enterprises are concentrated, four social inspection divisions have been created; four Occupational Risk Prevention Centres also have then" headquarters in Attica.

SEPE Occupational Risk Prevention Centres and local departments when in need of extra expert assistance such as when in enforcing requirements involving the measurement of exposure in relation to OELs, have access to the scientific and technical support of the Centre of Health and Safety at Work (KYAE) which is a separate Directorate within the General Directorate of Working Conditions. The basic objective of the Labour Inspectorate is to monitor the implementation of the provisions of labour legislation in respect of: terms and conditions of employment (such as working time limits and pay); the legality of employment; the investigation of workers' social insurance coverage; and, workers' health and safety conditions. The Labour Inspectorate has the normal range of powers found in most European regulatory inspectorates. Inspectors may use: -

Advice Improvement Notices Administrative sanctions Penal sanctions

232 Beyond Limits Limits 232 Improvement notice — An inspector may serve an improvement notice where s/he is of the opinion that a contravention of a statutory requirement has or is about to occur. It requires the person on whom the notice is served to make the necessary improvements to reach the desired standard. The inspector may specify appropriate remedial action and give a time limit of a maximum of 30 days in which to comply. An extension of a maximum of 10 days may be given if the time allowed in the first place is judged as insufficient. There is no appeal against the terms of the notice. Health and safety representatives should be given a copy of Improvement Notices. Administrative sanctions. The labour inspector may impose the following sanctions on any employer, manufacturer, producer, importer or supplier who infringes the provisions of the health and safety laws or the provisions of the presidential decrees or ministerial decisions issued under the terms of these laws, independently of the penal sanctions, on the basis of a fully reasoned decision and after summoning the person to provide explanations. The sanctions are as follows: -

a fine for each infringement ranging from €500 to €30.000 provisional cessation of the operations of the particular production process, or section or sections or the entire undertaking or firm for a period of up to three days.

The Minister of Labour may impose the following sanctions, after receiving a reasoned report from the labour inspector: -

temporary cessation of the operations of the particular production process or section or of the entire undertaking for a period of more than three days complete cessation of the operations of the particular production process or section or the entire undertaking.

The employer has 60 days from the receipt of the notice in which to contest the proposed administrative sanctions to the administrative tribunal of the region. If the employer fails to notify the inspectorate of his contest within 10 days, the assessed penalty is deemed final. In selecting and imposing the above administrative sanctions the following aspects must be bome in mind: -

the immediacy, severity and extent of danger

Greece 233

-

the seriousness of violation, subsequent violations, good -faith efforts, previous convictions the responsible police authorities shall execute the administrative sanctions of the cessations the above fines may be raised by decisions of the Minister of Labour after hearing the opinion of the OHS Council.

Penal Sanctions may also be imposed on any employer, manufacturer, producer, importer or supplier who willfully violates the Act or the rules promulgated by it. Offences committed due to negligence (on conviction) carry the full sanction of a fine or a prison sentence not exceeding one year.

SETTING EXPOSURE LIMITS As we outlined in Chapter 3, under Act 1568/85 (Chapter V, Article 24, Definitions) there were two types of exposure limit defined, 'Exposure limit values' (OELs) and 'biological indicator limit values.' Subsequently Presidential Decree (P.D) 338/2001 transcribed almost verbatim the Directive 98/94/EC "on the protection of the health and safety from the risks related to chemical agents at work". It redefined exposure limit values as follows: -

'Occupational exposure limit value' means the limit of the time-weighted average of the concentration of a chemical agent in the air within the breathing zone of a worker in relation to a specified reference period*. — "Biological limit value' means the limit of the concentration in the appropriate biological medium of the relevant agent, its metabolite, or an indicator of effect'. Greek OELs are the products of a compromise reached after considering health and administrative, political and economic issues. There is a two tier system in place to set OELs, comprising of a scientific advisory committee and a second level in the form of the National Council for Health and Safety at Work (SYAE) in which stakeholder interests are able to take account of health and administrative, political and economic issues. Negotiations take place within SYAE on all matters pertaining to occupational health and safety. It is effectively an institutionalized forum for national consultation on which 17 different interest groups are represented. Following agreement within SYAE, the General Directorate of Working Conditions of the Ministry of Labour, through its

234 Beyond Limits Directorate of Working Conditions is responsible for formulating the summary information report of the emerging decision on the exposure limit as a Presidential Decree. The first scientific advisory committee consisting of eight members made its proposals for 45 chemical agents, proposed the prohibition of an additional 12, as well as the reduction of the exposure limit values of benzene, vinyl chloride, asbestos, epichloridrine, a-chlorotoluene and exachlorobutadiene in a meeting of SYAE on the 2 June 1986. Subsequently, after considering HSE, NIOSH, ACGHL NSBOSH, DFG standards, SYAE decided to set limits for 39 chemical agents. Four of the 12 proposed in 1986 (see 98/24 EC Directive) were prohibited with a ministerial decision in 1989 following the 89/677/EC Directive. P.D.90/99 transcribed 91/322 EEC and 96/94 EC Directives on establishing a first and a second list of indicative limit values and amended article 3(4) of P.D.307/86 as it was amended by P.D.77/93. It also replaced the list of the 39 agents included in article 3(1). Following consideration of the available scientific and medical evidence, the scientific committee, now including a member of ELINYAE and a member of the Union of Greek Chemists, recommended a list of 553 substances with indicative OELs, largely based on sources such as the ACGIH list. Subsequently, P.D.339/2001 was issued in accordance with the 2000/39 EC Directive. It added four new indicative occupational exposure limit values to the previous list of 553 chemical agents (P.D.90/99), which already included the remaining 59 on the 2000/39 list. It also ratified the meaning of OELs as amended in P.D.90/99. In relation to lead, definitions of exposure limits for action are as laid down in the 82/605/EEC Dir.(P.D.94/87) and amended in P.D.338/2001(98/24 EC Dir.): 'If the assessment provided for in paragraph 1 reveals the presence of at least one of the following conditions: -

exposure to a concentration of lead in air greater than 75g/m3, calculated as a time-weighted average over 40 hours per week a blood-lead level greater than 40g Pb/100 ml blood in individual workers,

the protection provided for in this Directive (82/605 EEC), in particular the lead-inair monitoring and the medical surveillance set out in Articles 3 and 4, is to be given to the workers concerned.'

Greece 235

As far as the protection of the health and safety of workers from risks related to carcinogenic agents at work P.D.399/94 and P.D. 127/2000 have adopted 2004/37/EC and 97/42/EC Directives. The lists of limits endorsed in the P.D.s are binding and therefore may be potentially associated with legal sanctions. For agents not included in the Greek lists, but for which there are ACGIH values, such values are used as guidance by inspectors. In summary therefore, the present reality of provisions on chemical substances is an amalgam of prescriptive, sector specific (for example, shipbuilding), process specific (for example, welding), substance specific (for example, lead) Presidential Decrees of some age and of the more comprehensive and recent legal framework which provides a goal setting legislative framework requiring employers to assess and manage risks arising from the use of chemicals in the workplace. To this has been added every relevant EEC Directive that has been transcribed in conformity with European Legislation. Finally it is important to mention the role played by the General Chemical State Laboratory of Greece (GCLS), which is part of the Division of Environment in the state administration, in informing the practice of risk management of hazardous substances. While its authority on chemical safety is much wider than the workplace and more concerned with regulation of the market than with occupational use, it is important in relation to regulating the provision of safety information on the use of chemicals. Its activities cover the whole of the country and its mission comprises the protection of public health and the environment, consumer protection and the provision of scientific support to state authorities. It is the Greek competent authority for the control of chemical substances and it provides services to enterprises or individuals who wish to check the quality of their products.

THE ROLE OF O E L S IN ACHIEVING COMPLIANCE—IN THEORY The process and the principles of assessment of exposure are laid down in P.D.77/93 (ANNEX) as follows: 'If the presence of one or more agents in gaseous, vaporous or suspended form in the air at the workplace cannot for certain be ruled out, an assessment must be made to see whether the limit values are complied with. In this assessment, all

236 Beyond Limits points which might be relevant to exposure must be carefully looked into, for example: -

agents used or produced operations, technical installations and processes temporal and spatial distribution of concentrations of agents.

A limit value is complied with if the assessment shows that exposure does not exceed it. If the information obtained is insufficient to establish reliably whether the limit value is complied with, it must be supplemented by workplace measurements. If the assessment shows that a limit value is not complied with: -

-

the reasons for the limit being exceeded must be identified, the workers must be informed and appropriate measures to remedy the situation must be implemented as soon as possible the assessment must be repeated.

If the assessment shows that the limit values are complied with, subsequent measurements at appropriate intervals must be taken to ensure that the situation continues to prevail. The nearer the concentration recorded comes to the limit value, the more frequently measurements must be taken. If the assessment shows that, on a long-term basis, owing to the arrangement of the work process, the limit values are complied with and there is no substantial change in conditions at the workplace likely to lead to a change in workers' exposure, checks on compliance through measurements may be curtailed, after consulting with the workers. In such cases, however, the quality of the assessment leading to that conclusion must be monitored. If workers are exposed simultaneously or consecutively to more than one agent, this fact must be taken into consideration in evaluating the health risks to which they are exposed'. The new approach of SEPE in which evidence of appropriate risk assessment is an important element in regulating self-regulation, may influence current practice in relation to inspection and control of the management of risks associated with the use of hazardous chemicals, since checking risk assessment of risk of hazardous chemical agents is one aspect of monitoring risk assessment generally.

Greece 237

Complementing the practices of SEPE is the publication of guidance from the technical support unit of the Ministry of Labour, for health and safety (KYAE) and from the National Health and Safety Institute (ELINYAE). KYAE (1989) published guidance on the main methods of sampling and determination of chemical agents (airborne substances) in the working environment. ELINYAE (1997) translated and published the 1996 ACGIH Threshold Limit Values (TLVs) and Biological Exposure Indices (BEIs). The edition established the beginning of a scientific co-operation between ELINYAE and the ACGIH, In 1999 ELINYAE published and distributed an advisory document on industrial organic solvents in the interest of providing useful information and basic knowledge on their safe handling in industry for employers workers and others. The leaflet contained advice on control measures and emphasised the role of substitution/process modification, but made no direct reference to sampling methods, or to the role of OELs in determining what control measures should be used in OHS management (ELINYAE 1999). It also undertook surveys on the chemical and physical hazards in the printing industry, which led to dissemination of information on improved working practices in printing, including advice on substitution practices and improved ventilation arrangements (European Agency for Safety and Health at Work, 2003:104108).

THE ROLE OF O E L S IN REGULATING THE MANAGEMENT OF RISK IN PRACTICE It has been long recognised that the enforcement of labour law - and in particular occupational safety and health (OSH) legislation - has been rather weak in Greece.329 Although penal and administrative sanctions are severe enough in the legal texts, past experience is that the Labour Inspectorate has, in practice, rarely presented a significant sanction to employers, even those repeatedly violating the labour law. The situation deteriorated especially during the period 1995 - 1998, when the Labour Inspectorate was administratively devolved to Local Prefecture Authorities. Ironically, this weakening occurred at a time when a large number of European Union OSH Directives were under transposition into Greece's laws and institutions.

See for example, Spyropoulos G (ed) 2000 for a detailed account. Also Walters (2001: 197-202), for a brief summary of some of the difficulties facing OHS regulation in relation to the small firms that dominate the Greek economy.

238 Beyond Limits A further challenge to an empirical investigation of the role of OELs in enforcement is that the present structure of Labour Inspectorate databases means that a comprehensive analysis of enforcement activity, in as far as it addresses efforts to regulate chemical risk management and the inspectorate's use of OELs in this respect is not possible. Therefore some indicative results of local investigations undertaken expressly for this study are presented to supplement the rather meagre evidence that can be gained from examination of national data. The year 2001 was the first complete year of SEPE activity. The total number of inspection visits during 2001 increased by 71 per cent over previous figures. The total number of sanctions increased by nearly 75 per cent (Table 6.1). Table 6.1 Year 2001 2002 2003

Table 6.2

Number of inspection visits No of inspection visits 25,314 22,040 21,333

No of re-inspection visits 5,758 8,004 6,392

Total 31,072 30,044 27,725

Number of sanctions

Total Law suits Cessations Fines Amount of Fines Euros

2000 899 299 393 207 146,823

Sanctions Years 2000-2003 2002 2003 2001 1,577 5,260 6,299 892 1,429 1,608 611 1,495 1,650 3,041 744 2,336 2,261,945 3,085,526 552,457

Source: SEPE statistics.

There has been a considerable increase in SEPE enforcing activity resulting in quadrupling the number of sanctions -given of course the fact that almost half of the inspection visits in the years 2002-2003 took place in mobile construction sites (Olympic works and other.). Figure 6.1 shows the distribution of inspection visits and sanctions by economic activity for the year 2002. Furthermore according to its statistics in 2001 it undertook 1863 inspection visits in 1424 enterprises having more than 50

Greece 239 employees. Of these, 80 per cent used the services of a safety engineer while 70 per cent had an occupational physician. 142 enterprises had contracted with an EXYPP. Only 13 per cent of the 1863 inspection visits revealed the availability of a written risk assessment. In 49 per cent of cases no assessment had been undertaken while in the remaining 38 per cent, a risk assessment was under completion.330 SEPE showed an almost 100% compliance with all the above aspects in its report for 2002. Number of inspection visits and sanctions distributed by economic activity

12628

Figure 6.1

14000

10000

8884

12000

0

0

318

16

Other Services Provision

33

599

131

446 Money & Banking

Hotels & Restaurants

Wholesale & Retail trade

Construction

Manufacturing

0

Transport, Storage & Communication

653 29

2000

201

1444

4000

53

2780

6000

1103

4819

8000

• Inspections Inspections • Sanctions Sanctions

Unfortunately, because statistics on contraventions are classified according to various Presidential Decrees it is not possible to ascertain from these aggregate figures the

This situation should have improved somewhat during 2002 since it was decided than no enterprise with more than 50 employees shall be without a Safety Engineer or an Occupational Physician and a written risk assessment.

240 Beyond Limits

extent to which OELs feature in enforcement. There are known to have been a few prohibitions and improvement notices served in relation to monitoring strategies - and in relation to health surveillance with regard to lead and its ionic compounds, asbestos and asbestos products, as well as on the replacement of some dangerous industrial solvents with others less dangerous and the gradual replacement of PCBs electrical transformers. However, information on inspection strategies (below) would seem to suggest that it is unlikely that OELs play more than a minor role in enforcement. Inspectorate emphasis on OHS management is borne out by the observation that 32 per cent of notices related to PD 17/96, indicating the importance SEPE attached to risk assessment/systematic OHS management.

CHALLENGES FOR REGULATING THE MANAGEMENT OF CHEMICAL RISKS m GREECE There is a dualism characterising the approach to health and safety in Greek firms. At one extreme are the subsidiaries of multinational corporations operating in Greece, those firms that have established long-term strategic alliances with companies from abroad, firms which are parts of larger holding groups, and individual companies whose CEOs and other executives are professional career managers. These managers appear to be well-informed about the regulations concerning chemical risk and properly organised. It is in the organisations they manage that a 'European' approach to health and safety is most apparent and where the role of OELs has most similarities to experience in the other countries described in this book. At the other extreme are the far more numerous family-owned businesses, most often managed by their founder and major owner or his/her descendants. With rare exceptions, the CEOs and executives of these family-owned firms have no other managerial experience than that in their own firms and no exposure to management practices in firms outside Greece. Here the general awareness and understanding of requirements on the work environment and its significance in management strategies more widely is limited. These firms therefore lag far behind the 'Europeanisation' process both in terms of information and response to regulatory provisions (Walters 2001:198). A common characteristic of both groups however, is the lack of competent staff experienced in the legal, technical, implementation aspects of the provisions related to hazardous substances. In family-owned firms especially, there is an absence of scientific

Greece 241

support and coverage, not even an external one. This lack is considered by the GCLS as the main cause of a variety of breaches of the law noticed during enforcement action related to substances hazardous to health. These include: -

ignorance of the nature and hazards of products in production and circulation and especially of those imported from third countries dangerous products without labels or labelled incorrectly no text in Greek language on the packaging labels identical products that are labelled differently absence of product safety data sheets, or if present then not available in a Greek translation.

-

These problems are particularly significant since safety information data is an important aspect of overall occupational risk management strategies for hazardous substances.

ENHANCING COMPETENCE m RELATION TO HAZARDOUS SUBSTANCES The increased rate of inspection visits in combination with the increased number and activity of occupational health services provided by EXYPP has contributed to some increase in risk assessment that includes monitoring physical, chemical and biological exposures at the workplace (an example the extent to which such monitoring might be undertaken by an EXYPP is shown in Box 1 which documents monitoring activities of one EXYPP during the period 2000-2002). Box 6.1 Monitoring Activities of one EXYPP 2000-2002 Measurements were carried out in 29 enterprises (having more than 50 employees). They consisted of: -

21 for noise 14 for 'inert' dust 8 for concentration of solvents (xylene, toluene, ammonia, white spirit, isophorene, acetone, MEK, trichloroethane, trichloroethylene, alcohols) 7 for thermal distress (WBGT index) 6 for illumination 4 for concentration of chemical agents (formaldehyde, CO, CO2) 3 for air velocity 1 for concentration of filter tow 1 for electromagnetic radiation

In 22 of the 70 measurements the respective limits were exceeded.

242 Beyond Limits Notwithstanding this increase, the strategy of the inspectorate (as well as that of the EXYPPs) is orientated towards improving employers' awareness of the need for documented risk assessments overall. Actual measurement of exposure is estimated to feature only in around 10 per cent of written risk assessments. Policy documents and comments from health and safety practitioners shed light on this approach. For example, a circular to inspectors from the Ministry of Labour makes it clear that the immediate objective of the Labour Inspectorate should be to: '. . . increase inspections so that no small or medium sized company be left without being visited and registering its Safety Engineer and Occupational Physician with the Labour Inspectorate' (Polychroniou 2001). From EXYPP personnel:331 'We proceed carefully even in large enterprises to win them over in their duty to have a risk assessment performed in their workplaces leaving aside the inclusion of measuring occupational exposure (an expensive exercise) as a separate issue to be examined in due course . Such statements are clearly indicative of an approach in which awareness building concerning systematic health and safety management requirements is seen to be the objective to be achieved first, with the assumption that more detailed technical involvement will be more easily and more usefully attempted as a later follow-up once employers are committed to action on OHS management. The increased inspection rates and emphasis on ensuring all enterprises made appropriate efforts to register with Inspectorates (Law 2874/2000) also gave the Dr M. Velonalds, interview.

Greece 243 Technical Labour Inspectorates an opportunity to register thousands of SMEs in the Inspectorates' computerised archives and categorise them according to whether they were High (A), Medium (B), Low (C) risk workplaces under P.D.294/88. Classification of sectors such as metal manufacture, printing and wood furniture production in the B (medium risk) category created controversy among the small employers in these sectors and amongst their representatives in their association, the General Confederation of Professionals and Handicraft Traders of Greece (GSVEE). This was because a classification in the B category meant they were required to use the services of a qualified engineer (their own or external EXYPP) or a full time employee with eight years experience, technical education and training in OHS for the post of Safety Engineer and to contract with an Occupational Physician if they employed more than 50 employees. Not surprisingly this was perceived primarily as an additional cost by the industries that saw themselves in a period of economic difficulties.332 The employers' association therefore tried to negotiate their relegation and classification into class C (low risk) where owner/managers may themselves act as Safety Engineers with the only obligation to pass through a 10 hours training course in OHS. Following strong pressure on the Ministry of Labour a tacit arrangement was achieved which 'relaxed' the urgency of their immediate compliance. An additional circumstance that conspired to favour their claim was a decision taken within SEPE at that time, to focus on class A enterprises and on enterprises of any class employing more than 50 employees. Act.3144/2003, art. 9 complementing certain provisions of Act. 1568/85 enshrined the compromise solution with regard the risk categorisation and Safety Engineer's qualification as is shown in Table 6.3:

Such costs are estimated to be in the order of 74 euros per month far a typical small firm with less than 20 employees. They can be contracted with the cost of measurement involved in monitoring airborne exposure, which are said to be 440 Euros per hour.

244 Beyond Limits Table 6.3

RISK Class A A B B B

B

B

B

C

c

Qualification Requirements for Safety Engineers According to the Risk Classification of Enterprises

NUMBER OF QUALIFICATIONS OF SAFETY ENGINEER EMPLOYEES (E) 1" University Degree; 2nd U.D.or Techn. Education Institute E>50 3"1 and mor UD, TEI, Seo.Education E<S0 UDorTEI E>650 1" UD, 2nd UD or TEI, 3 ri and more, UD, TEI ,SE 50<E<650 UD or TEI First option: UD or TEI or Sec.E full time and proper training. Second E<50 option:The Employer himself holding a UD or TEI relevant to his economic activity. E<20 First option: UD or TEI or Sec.E full time and proper training. Second option;The Employer himself holding a UD or TEI not relevant to his economic activity but having 35 hours training in OSH. E<6 First option: UD or TEI or Sec.E full time and proper training. Second optionrThe Employer himself holding a Secondary Technical Education degree(TEE) or an HND (IEK) relevant to his economic activity but having 35 hours training in OSH. E<3 First option: UD or TEI or Sec.E full time and proper training. Second option:The Employer himself having a 35 hours training in OSH and a relevant licence or being in his craft for more than 10 years. E>S0 Is1 and 2nd UD or TEI. 3"1 or more UD, TEI, Sec.E. E<50 First option: UD or TEI or Sec.E full time and proper training. Second option: The employer himself holding a UD or TEI relevant to his economic activity. Third option: the employer himself having a proper training.

In establishments of B class having less than 20 employees and where the employer himself takes over the tasks of the Safety Engineer, s/he is obliged to have a written risk assessment performed by a person having a UD or TEI and specialty relevant to his economic activity in accordance with article 5 of P.D.294/88.

Greece 245

SECTOR SPECIFIC EXPERIENCES OF WOOD DUST AND TOLUENE In the sectors in which the two substances that were the special focus of our study are most commonly found - printing, publishing and allied industries; wood furniture and fixtures industries and fabricated metal products - risk management was not generally perceived as an issue by owners and managers. The role of monitoring compliance with OELs was therefore minimal. Wood Dust In the case of wood dust, part of the reason for this can be found in the fact that until quite recently the wood furniture industry itself was not regarded as particularly hazardous. Wood dust itself has never been identified a problem affecting indoor air quality and toxicological research (Pitiakoudis et al 2003: 615). It has not had a high profile such as has been the case in relation to for example, formaldehyde, cement dust or cotton dust (Kogevinas 1995). Indeed historically it was most noticeable as a subject brought up solely by the Greek Federation of Building and Allied Trades workers in connection with their argument for a financial bonus for unhealthy work for wood working machine operators and varnishing workers.333 The Labour Inspectorate did not begin disseminating written information on hazards and precautions for wood dust in relation to health (especially cancer) risks until the 1990s. Legal requirements for the control of wood dust. The control of wood dust is required by law. The Royal Decree 1937(10/9/37) 'On the protection of safety of workers and technicians employed in the woodworking factories' Article 42 states: 'exhaust appliances shall be provided at every sanding or producing wood dust machine as close to its production so that the dust is sucked at its source'. By virtue of Article 4 of P.D.307/86 the employer is obliged to take all the necessary measures of Article 26 of Chapter V Health and Safety at Work Act 1568/85 to avoid or minimise the exposure of workers to agents referred in Article 3 of P.D.307/86 (on the protection of the health and safety of workers from the risks related to specific chemical agents at work) wherever this is practically possible. In all events the level of exposure must be lower than the level defined as 'the exposure limit value'. Article 3 as amended

In 1981 they managed to gain an extra 2 per cent over their basic wage which was raised to 5per cent in 1982 and 7 per cent in 1992 after negotiating with the employers' confederation (SEV) and the Panellenic Federation of Wood Processing Craft Unions.

246 Beyond Limits by Article 3 of P.D. 77/1993 does not mention wood dust precisely or make any distinction between softwood or hardwood dust, but it does mention 'inert dust* and 'nuisance dust' giving an exposure limit value of 5mg/m for respirable dust and of 10mg/m3 for total dust. These limits are used as guidance for the assessment and control of exposure to wood dust under P.D.77/93 and P.D. 159/99 on risk assessment. Since the large majority of the workplaces in the wood furniture manufacturing sector are very small or micro-enterprises that are rarely inspected and also rarely use any form of EXYPP, the likelihood of a risk assessment being undertaken is quite remote, let alone measurements being taken to monitor dust levels, hi an interview with the CEO of an EXYPP with some experience of the sector it was stated that currently only five enterprises with more than 50 workers in the sector have a written risk assessment. Of these, according to the director of the EXYPP concerned, one carried out its own assessment while the rest were carried out by an external organization (EXYPP).334 The assessments included measuring exposure to dust. Air samples were below 5mg/m3, a great proportion were around lmg/m3. Although there were substantial increases in inspections and subsequent enforcement actions in the sector between 2000 and 2002 (516 inspections leading to 3 prosecutions in 2000, increased to 726 inspections and 28 prosecutions in 2001, 435 inspections and 85 prosecutions in 2002 increased to 314 inspections in 2003) it is not possible to determine how many of these made reference to wood-dust exposure or involved OELs in any way. Given the existence of the general inspection strategy described so far, and the known reluctance of many inspectors to engage with technical aspects of the risk evaluation of the use of hazardous substances, it seems likely that very few inspection and enforcement actions will have done this. However, exposure is likely to be quite high in many cases. Similarly, exposure to solvents, including toluene in the finishing processes of furniture making in the sector, is also probably quite significant although it may be marginally lessened by the introduction of water-based surface coating materials. If the enforcement actions on the part of the inspectorate reflect an increased demand for evidence of risk assessment and systematic OHS management, it is quite likely that they reflect the absence or incompleteness of evidence of risk evaluation through monitoring exposures to both wood-dust and organic solvents such as toluene. However, the future availability of a written risk assessment in this sector will also depend on the outcome

Dr M. Velonakis interview.

Greece 247 of the sector's negotiations on the issue of their non-compliance with P.D. 17/96 and P.D. 159/99.33'

Toluene In the case of toluene, it has only a limited 'separate' public existence as an organic solvent although it is a constituent 'Nitro solvents' a trade name for a mixture of solvents, such as BTEX, widely used in the sectors under discussion according to Soldatos et al (2003). Therefore, despite its widespread use, it has not been signified as a dangerous substance (such as benzene for example) and thus its risks also have limited recognition. Legal requirements for the control of toluene. The control of exposure to toluene is required by Chapter 5 of the Health and Safety at Work Act 1568/85. P.D.90/99 which transcribed EC Directives 91/322 and 96/94 EC Directives on limit values set new OEL for toluene at 100 ppm or 375mg/m3. It redefined the highest limit value (Short-TermBxposure Limit) as; '... a 15-minute time-weighted average exposure to a chemical agent which should not be exceeded at any time during a workday even if the eight-hour TWA is within the exposure limit value' and set it at 150ppm or 560mg/m3 for toluene. Experiences in printing. Printing, publishing and allied industries, include firms whose business is dominated by printing operations, firms performing operations commonly associated with printing, such as plate making or bookbinding, and publishers of books, newspapers, magazines etc. whether or not they actually print their own material. The industry is organised by the type of printing process used; lithography, (roto)gravure, flexography, screen, and letterpress, with different union and employer associations P.D. 159/1999 amended P.D.17/96 by adding to the special obligations of the employer with regard to his duty of a written risk assessment. Paragraph 5 makes explicit that the written document performed by the Safety Engineer and Occupational Physician or ESYPP or EXYPP, in order to be considered as complete and effective must include a qualitative and where necessary a quantitative determination of all the agents to which the workers are exposed in accordance with the existing legislation. The results of this determination as well as those produced by the relevant biological monitoring must be taken into account. The controversy mentioned above, resolved by Act 3144/2003, removed the 'suspended step' of enforcing article 8 of P.D.17/96 and its amendments in P.D. 159/99 and clarified who is performing the risk assessment in establishments of B class with E<20.

248 Beyond Limits traditionally representing its different parts. It has a high ratio of small operations, with nearly 95 per cent of printing facilities employing fewer than 10 employees. Flexographic and gravure printers, however, tend to be larger operations and to have more employees. According to 1998 Census data, in the printing and publishing industry there were only 232 firms with more than 10 workers, employing a total of 11,042 workers. This figure does not capture a number of 'in-plant* printing operations located throughout the manufacturing sectors or services. The diversity of technologies and products in the printing industry makes it difficult to characterise the processes and the workplace environmental issues facing the industry as a whole. Their differences can lead to distinct concerns and are critical when developing compliance assistance programmes. However, it is estimated that 97 per cent of all printing activities can be categorized within five different printing processes: lithography, gravure, flexography, letterpress and screen printing. The National Collective agreement that is negotiated and signed every year by the Panellenic Union of Lithographers, Graphic Arts, Press and Allied Trades specifically mentions the Employer's duty to comply with the provisions of; -

R.D.464/68 'On regulating the Health &Safety of those working in typography, and generally in Graphic arts and paper processing factories'336 Act. 1568/86 P.D.398/94 (EEC Dir.04/37VDU).

At the same time, a 10 per cent bonus for unhealthy and dangerous jobs has been agreed since 1994,337 It is given to those working in: -

rotogravure, flexography that use solvents, in systems UV, magnesium and bronze powder coating, metal printing ovens high speed web-fed offset when they are not enclosed so that exposure to noise, heat, and emissions is reduced.338

R.D. 464/68 was the product of a transitional phase in the industry from typography with its typesetting, and typecasting, to lithography with its plate development and the production of images photographically. P.D. 464/68 still comprises provisions relevant for the present heterogeneous situation in lithography etc in Greece. Previously it had been 4 per cent since 1964. 500g of milk (which still perceived to have antidotal qualities against poisoning from exposure to metal fumes, in addition to nutrition properties it has) is also given to the above workers.

Greece 249 The bonus clause, amongst other things, reflects the perception that the use of solvents is an activity dangerous to health (while hardly contributing to its prevention!). There is very limited officially published guidance on working with chemicals in printing and publishing.339 In a page reserved for chemical substances in such guidance that exists for owners and workers in small enterprises, there is a reference to the legislation on the handling of chemicals and a check-list of questions including: — 'Do you know that every packaging of chemical substances should be clearly labelled to show its hazards content?' — 'Do you know that it is the duty of the suppliers of hazardous substances to provide the users with information on the safe use of their substances?' — 'Do you know that for some substances used in our country there are OELVs?' In addition, to assist SMEs to perform risk assessment in their premises there is a translation of the UK HSE' s 'Five simple steps to risk assessment' that is also available. Such guidance is distributed by Labour Inspectors but, no data exists on the extent of its distribution to employers or to workers, or if and how frequently they use it. It is recognised that the worst area of control of hazards in the printing industry is in the management of hazardous substances. The great majority of improvement notices issued are in this area. No specific data is available on the extent to which inspections or enforcement actions have referred to OELs. However, the pattern of increased inspection activity is evident in printing as was previously noted for wood furniture manufacture. Thus, in 2000 there were 99 inspection visits recorded but no prosecutions, while in 2001 there were 223 inspection visits leading to 11 prosecutions and in 2002 there were 150 inspection visits and 20 prosecutions, hi 2003 there were 143 inspection visits. Employers and workers in small enterprises in the sector are in the hands of their suppliers for information on chemical hazards. Risk perception has been influenced by this relationship. Since there is almost complete absence of Manufacturers' Safety Data Sheets (MSDS) and the warning labels on containers are problematic, precautions are based on accumulated experience, smelling substances and using gloves where signs of dermatitis have appeared. Verbal information from suppliers, fellow employers and

See for example, IMPE1 Network (2002).

250 Beyond Limits workers filtered by the criteria of daily praxis and the suitability of the substance for the purpose for which it was bought, play major roles in decisions concerning risks.340 Emissions to air arise primarily from the organic solvents used in inks and in dilution. This is especially true for rotogravure, flexography and screen-printing. Solvents used in cleaning, the storage and handling of solvents and the use of organic solvents as dampeners are also important sources of emissions of organic compounds. The use of glues and adhesives is a further source of emissions. Toluene is used quite extensively especially as a constituent of the 'Nitro' mixture of solvents, but as mentioned previously its separate identity is not really acknowledged. Risk assessment has not yet reached small workplaces in printing, and safety engineers wherever they have a role to play rarely deal with the problem of hazardous substances. However, studies carried out on exposures to mixed solvents in a small sample of printing works around Athens show exposure to mixed solvents to be a significant problem (ELINYAE 2002). In recent years in some printing processes such as of flexography, screen printing, and offset printing, water based inks have been increasingly used instead of organic solvent based inks. According to the editor of one trade magazine interviewed for the project,341 there is an industry-wide move to the use of water-based inks. They are used currently by at least 60 per cent of offset printing firms whether small or medium sized. This development has also possibly led to a degree of complacency amongst opinion makers in the industry that it will reduce the future need for monitoring OELs in risk assessment. Experiences in metal fabrication— The fabricated metal products industry comprises enterprises that form metal shapes and/or perform metal finishing operations. They include establishments that fabricate ferrous and nonferrous metal products and those that perform electroplating, plating polishing, anodizing, colouring and coating operations on metals. The main processes associated with the industry can therefore be divided into three types of operations (i.e. metal fabrication, metal preparation and metal finishing), Again it is a sector of predominantly small enterprises. There are only about 348 companies (5 per cent of all companies) with more than 10 employees. Toluene exposure is present in many parts of the industry including: During the last decade annual sector exhibition s in Athens and Thesalonika have also become a source of information on risks. Mr Despotopoulos editor of 'Impressions-printing' (ediposeis-ektiposeis) a trade magazine for printing.

Greece 251 - manufacturing of metal frames and their parts — manufacturing of window and doors metal frames - forging, moulding, various-gauges printing and metal formation by milling, powder metallurgy - metal processing and overlaying (plating) — general mechanical works — manufacturing of light package ware. Once again, there is little specific information available on the role of OELs in risk assessment or the extent to which the Labour Inspectorate has included any reference to using them in its inspection and enforcement of the law. As in other sectors, inspection and enforcement increased between 2000 and 2002. Inspection visits rose from 1,077 to 1,551 and prosecutions from 29 to 82 in 2001 while in 2002 there were 1082 inspection visits and 199 prosecutions. In 2003 there were 884 inspection visits, but it is not possible to ascertain from these figures whether such increases have any significance for inspectorate monitoring of the role of OELs in risk assessment. Two case studies on Labour Inspectorate activities in metal fabrication give a sense of the way in which regulating hazardous substances is approached in the sector. They are summarised in Boxes 6.2 and 6.3. They demonstrate that labour inspectors are clearly involved in the regulation of hazardous substances and they show that in some cases this can involve making requirements for monitoring of exposure levels in relation to OELs. However, they confirm that inspectors are confronted with an enormous range of health and safety issues of which dangerous substances are but one aspect. They also demonstrate that achieving basic notions of good preventive health and safety practice are fundamental starting points for regulatory activity (as well as addressing substantial infraction of regulatory provisions). The relatively low starting point in terms of awareness and good OHS practices for many enterprises means that there is clearly much to be done that is likely to take precedence over the relatively sophisticated question of the extent of monitoring of compliance with OELs. There are indications that inspectors are indeed following the strategy, outlined previously, in which OHS management provisions are being applied through an initial insistence on the engagement of OHS competent persons and subsequently requiring evidence of risk assessments. Again, monitoring chemical exposures to ensure compliance with OELs, while part of this process, can be seen to be relatively far down the line of actions required (it is however, demanded on occasion, as is shown in Box 6.3). Inventories of adequate suppliers' information on the risks of substances in use on the premises is a much more frequent starting point for chemical risk assessment. Generally, the kind of control measures that are required by inspectors, while they may apply the accepted

252 Beyond Limits hierarchy of preventive principles, reflect fairly basic hygiene strategies whether in terms of information, engineering or personal protection, such as can be achieved and maintained without the need for sophisticated instrumentation or techniques.

Box 6.2 A painting workshop in a metal fabrication industry The enterprise employed 105 workers in a new plant. Since June 2001 it had used the services of a safety engineer who was a qualified mechanical engineer and full time employee. Since September 2002 the company had also used the services of an external occupational physician (who was an Urologist). Its painting activities take place in the open at the end of the production plant. Two painters and two assistant painters wearing simple overalls and shoes are engaged in the mixing process and spray painting. No local ventilation exists. The whole plant has a general ventilation system with unsatisfactory results. Although the company has used an EXYPP for its written risk assessment there were no measurements concerning the exposure of workers to organic solvents. MSDS in English were provided by the supplying company (protective materials for construction) after the intervention of the Labour Inspectorate who had issued improvement notices on this matter. It's interesting to note that in these sheets the company (having an ISO 9001) provided information in accordance with requirements of Directive 93/112/EC and made reference to COSHH regulations but not to any Greek legislation. Nor were OELs mentioned. Toluene was present in concentrations of greater than 40 per cent in one of the solvent used as well as in some of the paints. The safety engineer had no knowledge of the occupational exposure limits of toluene or the other substances. And the workers were not aware of the hazards involved. SEPE issued improvement notices concerning among others things, the inadequacy of the risk assessment.

Greece 253

Box 6.3 Steel products manufacturer This study is of a leading manufacturer of steel products in Greece, for the construction of metal buildings including an extensive range of metal sheet profiles and sections in addition to polyurethane panels which find application in industrial facilities, warehouses, airport facilities, sheds, etc. All products are manufactured according to international quality standards and ISO 9002 and are sold both in Greece and abroad. It has 250 Employees and employs a safety engineer as well as an occupational physician and now has a joint health and safety committee. It has undertaken a risk assessment and uses Material Safety Data Sheets. The SEPE diary between March 2001 and September 2002 reveals 10 inspections and seven re-inspections with one prosecution resulting in a fine of 68,800 in relation to this firm. Through the diary it is possible to follow how the SEPE labour inspectors served improvement notices concerning local exhaust ventilation in the coating line, bath, rotating parts, personal protective equipment, paint storage, the inventory of chemical substances, MSDS, monitoring capacity, instruments for measurements of chemical agents and the appointment of a chemical engineer as a safety engineer. It also shows how the notices were followed up in a series of re-inspection, each noting partial compliance and the need for an adequate risk assessment to be performed. Following a serious accident, critical examination of designing, ordering, introducing, testing and certifying new equipment was required. Inspectors suggested a meeting with the new general manager, the management team and worker representatives to discuss risk management in the company. One outcome of the meeting was the election of a joint health and safety committee. At the same time a prosecution was initiated concerning the company's failure to comply with its duty to make a risk assessment in accordance with P.D. 17/96 and P.D. 159/99. Further inspections resulted in a letter to yet another new general manager (there were three during the period of the diary) concerning strict application of legislation regarding the control of hazardous substances P.D. 94/87, 77/93, 395/94, 399/94, 16/96, 90/99, 127/2000 and the obligation to undertake measurements. The inspectorate requested help from KYAE to perform its own risk assessment to see whether the limit values are complied with and establish reliability. Some months later the company reported completion of a risk assessment undertaken by a EXYPP. Further inspections and accident investigations followed with a range of non-compliance items identified and remedial actions demanded. Some concerned hazardous substance such as requirements for monitoring lead levels. Overall actions were deemed inadequate and a fine of 8800 euros was imposed for infringements related to P.D.395/94,397/94,16/96.

254 Beyond Limits

CONCLUSIONS: THE LIMITED ROLE OF O E L S IN CONTROLLING RISKS OF HAZARDOUS CHEMICALS IN THE WORKPLACE Until very recently in Greece the issue of hazardous chemicals has not really featured in public debates on health and safety at work, despite information suggesting that one in seven workers reported a problem with toxic substances. Even now, the over-riding consideration is the need to operationalise the requirements of the Framework Directive on the regulation of occupational health and safety management. The approach has been a cautious one. The promotion of safe handling of hazardous substances - to the degree that one can isolate it both in practice and in its conceptual context within the national strategy to achieve systematic OHS management seems to be based on the following assumptions: -

Vigorous and rigorous enforcement activity by SEPE will change the status of control and the employers' perception of carrying out their duty of risk management in their workplaces. It is believed that in the long term the new approach of SEPE that takes advantage of risk assessment in regulating selfregulation in an adequate and effective way could have positive effects on current practice. This is predicated on the condition that SEPE does not only pursue the establishment of written risk assessment in firms but at some stage also checks the assessment of risk of hazardous chemical agents.

-

The bipolar system of trained safety engineers and occupational physicians (that constitute the specialist personnel of the EXYPP and ESYPP) will serve to reduce the great deficit in knowledge in relation to securing improved management of chemical risks within the systematic management of health and safety generally.

-

By applying systematic health and safety management according to the principles of the EU Framework Directive, as transposed by PD 17/96, using risk assessment, evaluation and control, the extent of exposure will be mapped out and reduced. If the wider systematic OHS management measures already taken are adequate, the concentration of workplace pollutants in air should be reduced, thus minimizing situations requiring monitoring. The Labour

Greece 255 Inspectorate will therefore only need to require monitoring by exception, if reasonable doubt exists about the situation in a company. -

The EXYPP may provide the technical support to employers to enable them to understand the role of OELs as well as undertake monitoring for them.

-

Increasing demand for OHS services will increase the need for other disciplines to enter the field of health and safety and especially people trained in monitoring.

-

ELINYAE will fulfil its objectives in the domain of OHS most of all in the area of training and in producing practical guidance complementary to the Ministry of Labour.

-

The General Chemical State Laboratory of Greece will make its enforcing presence felt on suppliers, importers and manufacturers in order to deliver chemical information in the Greek language to SMEs.

It also assumes that the following difficulties will be overcome: -

The 'general and multifaceted lack of resources' (Nichols 1997), the rigidities and the enduringness of certain mentalities among employers and workers in small enterprises.342

-

The absence of general knowledge required for protection from hazardous substances, evident in the vast majority of small and medium-sized companies.

-

A culture in which owner managers of small and medium-sized companies receive information and support from those who they already trust. This means that when deciding what steps to take to protect employees, chemical users rely mainly on information from suppliers, rather than the carefully crafted For instance, the majority of SMEs in the metal fabricating sector have grown out of larger enterprises (such as steel and aluminium plants, shipbuilding, metal construction) In them, heavy, unhealthy and dangerous work is the norm. Handling solvents is a small and insignificant aspect. This helps create a small enterprise owner manager with a self-image as a survivor who 'escaped' from the crowd of factory workers and climbed socially, first by becoming a sub-contractor and then a boss. There is little room for practices and sensitivities on prevention and employee health protection in such an experience based on self-image. In the furniture and printing sectors employers and workers alike are characterised by their 'craft-guild microcosm' and its "habitus' where exposure to dust and solvents is viewed a 'normal' occurrence almost in every phase of production process.

256 Beyond Limits regulatory system of legislation and guidance from other sources such as ELINYAE or Labour Inspectors.343 -

The use of process controls (ventilation systems, enclosed systems or modification of the process) that technology offers and market competition imposes, develops asymmetrically in the three sectors. Little thought is given to priorities such as eliminating the hazardous substance or using it in a safer form. Even personal protective equipment is rarely used.

-

The OELs system is poorly understood by almost everybody in the field including many labour inspectors who are therefore reluctant to see it as an integral part of the regulatory approach to control measures for health protection.

-

Trade unions that continue to negotiate and support financial bonuses for unsafe work contributes to an ideology hardly conducive to prevention and delivers mixed messages for workers' participation in risk assessment and risk management.

-

Occupational risk awareness and militancy among workers is unevenly distributed across the different sectors of economic activity; the construction sector being the most militant followed by the metal sector while the furniture and printing sector lag a long way behind.

-

While many trade union activists who developed during the 1980s believed that the promotion of health and safety behind the factory gates was part and parcel of their political struggle for industrial democracy they have become demoralised by unemployment, which has reversed the relation of forces in factory politics and reduced the significance of OHS as an organising issue.

It is very recently indeed (only the last year or so) that the idea of risk assessment has started to be understood by large industries. Small enterprises are still far from reaching this point, the majority regarding the services of a Safety Engineer as a new burden on their budget or as another trick of the government to create jobs for unemployed engineers. In the words of a spokesperson for the printing trades on the requirement to use Safety Engineers:344

For example, safety data sheets, the major source of information on chemical hazards are generally not available, even if they are, they are often not translated into Greek and, are inadequate both in qualitative and in quantitative terms. Mr Palas, President of Printing Owners' Union of Piraeus and Vice president of Craftsmen Chamber of Piraeus,

Greece 257 'I can't hide the fact that there is some mumbling about it which reflects our mentality more or less. It is however an EEC law that concerns the health and safety at workplaces. As a union we are for it despite the problems that may be created. The Safety Engineer is indispensable for the reduction of labour accidents of which there are quite a few. However I think that the law should be changed and relegate us to the low risk C class so that the employers could be able to assume for themselves the role of the Safety Engineer - after some training of course- instead of having an employee or an external engineer who would visit us twice a month to pocket our money'. It was anticipated in planning the interviews for the present study that the number of key informants would be limited, however even those that were expected to be well informed and well placed to comment on the realities of workplace practices in relation to the subject matter of the study often had little to say about the role of OELs in managing workplace chemical risks. Apart from the clear infrastructural weaknesses and resource limitations in the Greek system for regulating OHS overall, a possible explanation for the reluctance to engage with OELs may also lie in the perception of OELs as part of a medically dominated schema in which they are especially associated with measurements. Measurements are themselves associated with instruments and with professional/outsider/authority figures, signifying interference with the employer's freedom in the production process and probably the loss of a worker's job. Thus the following statements reflect the tenor of some of our interviews. An occupational physician who works for an EXYPP suggests employers' attitudes to professional occupational health and safety practice in their firms were not dissimilar to some lay attitudes to relations with physicians in general:3*5 'I don't go to have a check up because I am afraid that Doctors will find something, which I don't want to know at the moment.. .these Doctors they always find something. While a senior regional trade union organiser says of exposure levels:346 'Don't make a fuss about it, other things have priority, it's a luxury to ask for monitoring when unemployment runs high'. A typical employer and owner manager in a small printing works said:347 Dr Stelios Papadapoulos. Mr A. TiUgadas, President of the Labour Centre ofVolos.

258 Beyond Limits 'I've been breathing the same air as my workers for 20 years now, nothing has happened to me so far.' And: 'If you go along with your insisting on monitoring we will end up wearing a mask. Why bother wearing a mask? Masks are for the carnival!' Furthermore it is apparent that as long as the employer seeks cheaper solutions such as providing personal protective equipment because other solutions are perceived as costly (and apparently they don't even do this very often), the role of OELs cannot be clarified because it is not sufficiently tested. Overall this means that the whole system and culture of prevention in Greece does not yet enable the use of OELs to be evaluated beyond an impressionistic level and even this is problematic. There is not a critical mass of data and experience sufficient enough cautiously to conclude more than the following; — The application of monitoring of chemical exposures in the workplace needs professional input and is labour intensive. -

Experts see monitoring as a difficult exercise that can probably only be undertaken properly by a very small number (some ten to fifteen) hard-to-find persons in the whole of the country. They continue to emphasise the complexity and sophistication of expertise necessary to understand for example, problems of individual susceptibility, synergistic effects, non consideration of skin absorption, oscillation of concentration. Thus, making the whole idea of monitoring an adventure that is unlikely to be embarked upon voluntarily by the average employer.

— EXYPP personnel regard monitoring as the end phase of a game of diplomacy that is expensive and scares employers. Nevertheless they press SEPE to increase its demands for monitoring so that they can have a return on their capital investment in monitoring instruments. -

KYAE does not have the resources to engage extensively in monitoring to undertake tasks such as cross checking when results are disputed by workers' representatives. Organisational changes in the structure of the labour

Mr A. Xourafas, owner manager of a small offset printing firm with a family history in the printing trades.

Greece 259 inspectorate also make it more difficult for SEPE to use KYAE to satisfy its need for expertise. -

At the same time, SEPE's own resources and training of inspectors in monitoring is insufficient to make them confident in using it when dealing with OHS issues for hazardous substances.

-

Safety engineers are rarely well trained, confident or equipped to deal with technical aspects of chemical handling and use (unless they are already chemical engineers by training).

-

Occupational Physicians, with the exception of the few that see have seen a market opportunity and set up EXYPPs, scarcely bother to take initiatives on workplace chemical exposures.

-

Internal chemical control is minimum even in large enterprises, and even in enterprises in the chemical industry itself. There is no product stewardship. As one EXYPP physician348 stated; 'They do as much as to avoid being in trouble, and most of the times they do it under pressure from the inspectorate or the daring few workers who speak out'.

-

From a trade union point of view, those with any knowledge of OELs argue that it is politically better to have limit values than not. However, they insist that respecting limit values does not mean that there is no risk for the safety and health of the workers. They are also considered to be a very useful tool to document the exposure situation of workers to chemicals during their working life and to have uses as levers to ask for more money as well as to demand better conditions of work.

This rather challenging scenario for the role of OELs in regulating the management of chemical risks is a more extreme situation than is found other countries in the study. However, it is not altogether different from what can be observed elsewhere in Europe. As we shall continue to see in subsequent chapters, in other countries with more highly developed regulatory infrastructures for health and safety and greater application of the regulation of OHS management, there is also considerable ignorance of the role of monitoring workplace exposure to hazardous substances, especially in the majority of small enterprises. Monitoring does not take place in many situations in which it is

Dr Stelios Papadopoulos.

260 Beyond Limits technically and legally a clear option. Organisations representing small firms in other countries have also sought low risk classifications for the economic activities of their members (based largely on size), exempting them from the necessity of technical evaluation of workplace chemical exposures. There are limitations both in terms of the required resources, and the technical skills of prevention services and regulatory agencies that restrict the amount of monitoring that takes place. The limited willingness and capacity of employers to engage in the activity remains a major factor ensuring that the role of OELs in risk assessment is relatively underdeveloped, and as we shall see, in all these countries OELs are also valued and used as much for their political and symbolic meanings as they are in the practice of monitoring compliance with risk management requirements for chemical risks. Moreover, much of the regulatory strategy in Greece is not really that different in principle from current approaches found in most other countries. As in other countries, better OHS management is the overall target. OELs, if they feature at all, do so way down the sequence of events that operationalise the OHS management requirements of the national provisions that implement the Framework Directive 89/391. OELs are not the drivers of improvement in chemical risk management. In Greece, as in other countries, technological development and other factors that influence it such as cost, are viewed as the most significant influences determining improvements in exposures to hazardous chemicals. In this sense in Greece, the adaptations of technology would seem to move faster than 'Europeanisatkm1 in OHS management.

261

7 ITALY

INTRODUCTION The Italian chemical industry is the fourth largest in the European Union, after Germany, France and the UK, with some 12 per cent of the production of the EU 15 countries, hi addition to their use in the chemical industry itself, chemicals are widely used in many other Italian workplaces. According to the results of the Third European Survey of Working Conditions (2001), the percentage of workers who thought they were exposed to breathing in vapours fumes, dust or dangerous substances for all or a substantial part of their time at work was slightly less than that for the average for the EU as a whole (4.2 percent in Italy compared with 4.9 per cent average for the EU). Approximately 15 per cent of Italian respondents to the same survey thought themselves not well informed on chemical risks, compared with an average of around 10 per cent for the EU, while a far larger proportion (around 36 per cent) of Italian respondents thought they were either very well or fairly well informed about the risks of using materials handled at work (compared with an average of 38 per cent for the 15 EU states that participated in the same survey). However, these results need to be seen in the context of widespread concern about the quality and availability of information on chemical hazards, especially in relation to the small and medium sized enterprises where the majority of the Italian labour force work. In 2003, when the focus for health and safety for the year was on the risks of hazardous substances, researchers at the Istituto Superiore per la Prevenzione e la Sicurezza del Lavoro (ISPESL) conducted an analysis of recorded national work-related injury and ill health data to determine to what extent chemical substances were implicated in the causes of occupational injury and ill-health (Avino et al 2003). They found evidence of the association between chemical substances and injuries and ill-health to be widespread throughout nearly all the categories of economic activity and especially strong in metal manufacturing, construction and in agriculture where more than 10 per cent of injuries

262 Beyond Limits and recorded diseases were associated with exposure to chemical substances. Other sectors where there were high proportions of injuries associated with chemical substances included the manufacture of food and tobacco products (8 per cent) and in health and social work, while for occupational diseases the manufacture of non metallic mineral products (8 per cent) and transport equipment (7 per cent) both had relatively strong associations with the use of chemical substances. Given the wide acceptance that the nature of the reporting systems that led to the generation of this data can be predicted to produce extremely conservative estimates of possible associations, the proportions identified probably represent only the tip of the iceberg.349 The same report also points out that organisations representing small and medium sized enterprises in the craft sector in Italy have identified particular difficulties facing employers and employees in these firms in obtaining and using good quality information on chemical hazards and safe use of chemicals. It concludes with the statement that priority actions in Italy for the future must include: "... information and training for all key players in the safety scenario (employers, workers, workers' safety representatives, prevention and protection service executives, company physicians etc.) to meet the urgent need to acquaint SME and craft firms with methods of addressing chemical risk, establishing preventive and protective measures and encouraging the development of a safety culture'. Other, more specific studies reach a similar conclusion. For example Pegna and Terracina (2004) point out the absence, until quite recently, of any practical guidelines or criteria on managing chemical risks in relation to compliance with the Italian laws to implement EU Directives on chemical agents. Therefore in order to understand the practical realities of the role of OELs in Italy it is necessary to place them within the context of the Italian system for regulating occupational health and safety. One of its distinctive features is that traditionally it did not provide a legal status for OELs within OHS regulation. The only limit values adopted nation-wide were those arising from the transposition and implementation of European Directives on carcinogens or specific substances like asbestos, inorganic lead or vinyl chloride monomers. Transposition of recent EU requirements like the Chemical Agents Directive and the IOELV Directive made under it therefore challenge the Italian tradition as well as some of the basic principles that are seen in Italy to be guiding it. In addition, requirements of EU Directives on health and safety are essentially centralist in See Walters (2001:65-71) for a review of the sources of such information and their limitations.

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orientation and largely constructed around models of administration, inspection and control typical of the majority of member states. There were therefore also likely to be administrative problems surrounding their implementation in the highly regionalised systems of the Italian state. In order to maintain the standards intended by the national legal system, while at the same time embracing the requirements of EU Directives, considerable legislative ingenuity has been required. To appreciate the reluctance of the Italians to set OELs it is necessary to first revisit the principles on which the traditional system is based and the way they are intended to function. This is not only a matter of legal principles; securing compliance with the regulatory system is an issue for agencies charged with this task. The means and strategies they adopt are to a large extent derived from the legal principles set out in the Constitution and in the basic legislation on workers* protection that has been in place for many decades. Change in legislative requirements on OELs therefore also implies considerable challenges for techniques of inspection and control. Complicating factors for both the development of new legislation and the practice of securing compliance with it include the: -

extent of regional devolution of authority

-

major involvement of the public health system in regulating health and safety and the relatively minor role of the Ministry of Labour in this practice

-

legal status and role of collective agreements in the practice of workers' protection.

In the following chapter we shall explore these issues and consider their implications for managing chemical risks and especially for the practice of securing compliance with OELs. We begin with some general points about the Italian regulatory system for occupational health and safety and its structures and procedures relevant to setting and using OELs. This is followed by an outline of the approach currently taken to reforming the system to meet the requirements of the Chemical Agents Directive. Finally we consider the role of OELs in the strategies and practices of inspection and control. As with the other national chapters, the material in the following sections has been derived from published sources and from interviews with key participants in the country concerned.

264 Beyond Limits

THE ITALIAN MODEL FOR REGULATING HEALTH AND SAFETY AT WORK The economic and political context of occupational health and safety involves a complex interweaving of institutions and instruments in Italian society. State provisions and collective agreements interconnect and policy related to work must normally be acceptable both to the unions and employers* organisations. Institutional checks and balances in the parliamentary system mean that political exchange and negotiation between executive and legislative branches of government may pose serious obstacles to radical policy initiatives. Although Parliament may adopt broad policy in primary legislation, it does not necessarily mean that the executive will draw up the detailed statutory instruments it requires to be implemented. This is vividly illustrated by the fate of the legislative reforms to the national health system that were initially introduced in 1978 (see below). According to Vogel (1993:331), Act 833 that instigated the reform: 'incorporated major achievements made by social movements and, in particular, the active struggle of the labour movement, but left it to Government to draw up the statutory instruments needed to implement the broad principles. Far from accepting its instrumental task of giving effect to the legislation passed, the executive branch in fact arrogated a power of permanent re-negotiation which allowed it to neutralise or attenuate the scope of principles of which it did not approve'. The system is further complicated by the 'tacit regionalism' that exists in the country, which allowed for considerable leeway between regions in what they chose to adopt as the means for delivering national policy and legislative objectives. The difficulty of controlling the application of the law in a labour market characterised by the highest proportion of craft and small enterprises in Europe and a buoyant hidden economy is a further significant factor. Health and safety has been included in collective bargaining at national and enterprise level for many years. At the same time, the character of the Italian system for regulating health and safety at work before the transposition of the Framework Directive 89/391 was profoundly different to that of other EU member states in the way it conceptualised workers' occupational health, the responsibility for it and the structures and processes set up to protect and promote it. The notion that workers have a right to collective control over their own health was arguably fundamental to the Italian approach to regulating health and safety and more explicit than in other EU countries. It gave a

Italy 265

rationale for the role of public health structures with both advisory and inspection functions in supporting workers and their organisations to achieve better health and safety at work. The involvement of the national health system - in which occupational health and safety was included - was a result of the unrest of the 1970s, but it was in a continual state of reform since its inception in 1978 until well into the 1990s. This gave rise to an increasing regionalisation of its organisational model during the 1980s. These changes were still underway in the early 1990s when Italy was required to transpose the raft of EU health and safety Directives led by the Framework Directive 89/391. Transposition was undertaken with extensive debate and considerable difficulty despite a consensus on the importance of transposing the European model of OHS into the Italian context. The need to reform OHS services and to achieve better performance in health and safety at work was widely recognised and indeed, became part of the political agenda.350

LEGISLATIVE BACKGROUND Workers' health and safety, a basic constitutional right. There has been a long-standing interest in protecting the health and safety of workers in the Italian legislative tradition. The 1948 Constitution specifically recognised health as a fundamental right that should be achieved by taking the preventive measures that are technically feasible regardless of the economic costs involved (Article 32) and laid down a general duty of work protection. Article 35 established that protection at work was a public constitutional responsibility. Article 41 recognised private entrepreneurial activity. However, such activity must be neither against public interest nor prejudice safety, liberty or human dignity. This principle considered in conjunction with article 2087 of the Civil Code has led to the interpretation that the employer's duty of safety should be juxtaposed, not to a simple legitimate interest but to a corresponding workers' right to safety. A key law on prevention of accidents was adopted in 1955 laying down general principles addressing a wide range of issues. It defined employer's liability and required that they inform workers about risks and ways to prevent them. The Presidential Decree 303/56 'General provisions for industrial health" was approved in 1956 reaffirming the obligations of employers. It formed the core of the health and safety at work legislative framework. The general principle was that employers should do everything technically

See Rivest (2002: 145-175) for a more detailed description of this situation.

266 Beyond Limits possible to reduce risks. It also provided for workers to have health checks by competent doctors at varying frequency depending on the nature of their work. Health and safety as an issue for workers' rights and national health service reform. In the 1970s and 1980s the health and safety system underwent fundamental changes influenced by campaigns on the control of working conditions and the refusal to put a price on workers' health. At the basis of the reforms concerning health and safety at work were two pieces of legislation: the Workers Statute (Act 300 of 1970) and the National Health Service Act 1978 (Act 833). The impact of these two statutes was farreaching and set up a unique system of representation and health and safety at work in which public health authorities and trade union organisations were central actors. According to Vogel (1993: 309-10): 'one of the most important characteristics of the 1978 reform was to assign the public health services far more onerous responsibilities in the area of occupational risk prevention than in other European countries. Also workers' rights to act of their own in this area implied more than simple participation. Overall, the general nature of the provisions of the Workers Statute and Act 833 makes collective agreements decisive to the framing of prevention policy.' Article 9 of the Workers Statute (the Terms and Conditions of Employment Act 300, 20 May 1970) implied that workers, not as individuals but as a community, were to be active in the implementation process of prevention and safety. Hence the framing of preventive policy is defined within collective agreements. The adoption and implementation of the Framework Directive. Measures to implement the Framework Directive provide a regulatory structure within which all aspects of risks to health at work are to be managed. Specific measures addressing chemical risks and the role of OELs are made within this framework, so it is important to be clear about its content before we examine the nature and application of these measures more specifically. Adoption of EU directives on OHS began in 1991 with DL 277/91 that implemented five Directives including measures on workers' protection against noise, asbestos and lead; and anticipated some contents of the Framework Directive (Walters 1996: 124). This decree was important, not only for introducing European directives into the Italian legislation, but also because it was a first endeavour to integrate 'European' concepts to the Italian system, for example, in requiring risk assessment to be carried out by companies. Previously, only the public preventive service assessed workers exposure.

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Introducing this concept in the specific areas covered by the Directives, paved the way for the later introduction of risk assessment more generally, as required by the Framework Directive (Frigeri 1994:10-11). The Framework Directive was transposed into Italian law by legislative decree 626Y94.35' Transposition required extensive overhaul of the previous system. The application of the Decree 626794 was characterised by delays, pressures from the employers associations on the government to modify its content and the adoption of numerous amendments and further legislative measures specifying principles established by the Decree or postponing its application. While the Decree was adopted in September 1994, it was the end of 1997 before implementation was mostly realised and it is still not entirely complete. The new structure of employers' obligations introduced by the Decree did not change the general principle according to which the employer must avoid work-related damages. Within this principle however, Decree 626 has introduced a new legal notion of prevention and has added manufacturers' and wholesalers' obligations, as well as those of project and installation managers. It requires employers to have the competencies to undertake workplace risk assessment and surveillance and prevention services must be organised internally or externally.352 Tasks of prevention include identification of risks and their assessment, elaboration and implementation of a safety plan, information and training. Arrangements for workers' participation in health and safety were profoundly changed by the requirements of the Decree, with the introduction of specific workers' representatives in health and safety for all enterprises whatever their size.353 Outside the enterprise, the Decree provides that The Decree 626 transposed the Framework Directive 89/391 and seven other Health at Work Directives - on the workplace, the use of work equipment, the use of personal protective equipment, the manual handling of loads, work with display screen equipment, protection against biological agents and protection against carcinogens. It has to be managed internally in sectors using dangerous materials or in enterprises with more than 200 employees. However the legislation did not make enlisting external prevention services compulsory where skills available internally are sufficient. Also it did not define the competencies of workers appointed to form company (or external) services. The European Commission recently complained to the European Court of Justice (ECJ) on both these issues and its complaints have been upheld in the ECJ's ruling in case C-49/00 on 15.11.01. According to the Decree in all enterprises whatever their size a safety representative (ELS) must be elected or nominated. In enterprises employing 15 or less workers the safety representative is elected directly from employees. To help these small enterprises coping with the obligation of having a safety representative, the Decree opens the possibility of having territorial safety

268 Beyond Limits at territorial level joint bodies between trade unions and employer associations are set up with the objectives of supporting and promoting initiatives for the employees. They are especially intended to be active in providing support to SMEs in matters of health and safety and they are to collaborate with employers, workers safety representatives and Local Health Authorities (USLs).

MEASURES REGULATING CHEMICAL RISKS Regulatory system and responsible bodies. The regulation of occupational health and safety in Italy is based on both public health and labour policy and therefore includes the involvement of the institutions of both these larger systems.354 Public health. Preventive occupational health and safety is a function of the National Health Service (Servizio Sanitaria Natianale - SSN). The Ministry of Health (Ministero della Sanitaf55 is the central body and its main tasks consist of the national planning and co-ordination of all matters regarding public health. Public agencies (monitored by the Ministry of Health) act as technical-scientific bodies for the SSN. They include: -

The National Institute of Occupational Safety and Health (Istituto Superioreper la Prevenzione e la Sicurezza del Lavoro - ISPESL)356 The National Institute of Health (Istituto Superiors di Sanita - ISS)357 The National Advisory Committee on Toxicology (Commissions consultiva tossicologica nazionale - CCTN).

representatives (RLST). Therefore in such enterprises the safety representative maybe nominated for enterprises operating within the same industrial district. S/he can be nominated or elected in the context of trade union representation as determined by the collective agreement. In enterprise with more than 15 employees the safety representative is elected or nominated by employees in the context of the trade union representation of the enterprise. If such representation is not in place, s/he will be elected by the employees. http://itosha.eu.int/systems/oshsyst.htm, http://www, sanita.it/. http://www.ispesl.it/. http://www.iss.it/.

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Labour policy. The Ministry of Labour and Social Affairs (Ministere del Lavoro e delle Politiche Socialifi% plans and co-ordinates national policy and strategies on labour and employment. The Labour Inspectorate is part of the Ministry. The main bodies involved in health and safety under the auspices of the Ministry of Labour and Social Affairs are: -

The National Institute of Insurance against Accidents at Work (Institute Nazionaleper L 'Assicurazione contra gli Infortuni sul Lavoro -INAIL)359 The Italian Institute of Social Medicine (Istituto Italiano di Medicina Sociale IIMS)360 The Permanent Advisory Committee for Accident Prevention and Occupational Hygiene (Commissione consultiva permanente per la prevenzione degli infortuni e I'igiene del lavoro)^

Occupational Exposure Limits'" In Italy, as we have already pointed out, traditionally there has been no national system for establishing OELs. Legislation limiting exposure to hazardous chemicals generally comes in the form of decrees by the Italian Government or the Ministries of Health and Labour.36* Italian measures to transpose the main European Directives dealing directly or indirectly with the risks arising from dangerous substances at work, include:35* -

358 358 360 361 362 m 364 365 366 367 368

Decreto Legislativo n. 626 del 19/09/1994 — transposition of Directive 89/391/EEC and 90/393/EEC365 (amongst others) Decreto Legislativo ISfebbraio 2000, n66- transposition of Directive 97/42/EC and 1999/3 8/EC366 Decreto Legislativo n"277 del 15/8/1991 - transposition of Directive 80/11Q7/EEC387, 82/605/EEC,368 83/477/EEC369 (amongst others) http://www.minwelfare.i1/defaultgen.asp. http://www.inail.it/. http://www.iims.if. http://www.area.fi.cm.it/guests/preveiizione/cap5.pdf. Information given b y the ISPESL, contacts within the Italian trade u n i o n s . Information given b y the ISPESL. http://europa.eu.int/celex/. Carcinogen Directive. l " and 2™1 modification o f the Carcinogen Directive. Chemical, Biological and Physical Agents Directive. Directive on Lead.

270 Beyond Limits -

-

Legge 29 dicembre 2000, n. 422 - delegates to the Government the right to issue the decrees for the implementation of 27 EU Directives within one year, amongst others for Directive 98/24/EC370 Legge 2febbraio 2002, n.25 transposes the Chemical Agents Directive.

No official list of OELs has existed in Italy in the past. The only limit values adopted nation-wide are those arising from the transposition and implementation of European Directives on carcinogens or specific substances like asbestos, inorganic lead or vinyl chloride monomers. They are binding limit values and are not health-based because socio-economic and technical feasibility factors were taken into account when they were established at European level. In addition to these measures, in 2001 the Italian state began its measures to transpose the Chemical Agents Directive and the IOELV made directive under it. hi essence, the new legislation is a translation of the requirements of the Directives. It therefore requires that the limit values of the IOELV Directive are adopted as Italian measures. This is itself controversial, as setting such values is a departure from Italian practice. An equally prominent focus of debate concerns the degree of risk present in an enterprise that requires a duty holder to monitor the application of the values. The controversy is largely centred around the terminology used to describe the level of risk at which duty-holders are required to take action. This has given rise to much criticism and confusion concerning when exactly action is required by the legislation. As a result national and regional level technical committees have been established with the task of defining more precise guidelines (see below). In addition, TLVs of the ACGIH have sometimes been included in sectoral collective agreements between trade unions and employers* organisations.371 hi Italian law such agreements have a legal status. In sectors where agreements between employers' organisations and trade unions refer to the US ACGIH list, it provides for OELs that are compulsory in these sectors. For example, the ACGIH list of TLVs was used as reference in the Contratto Collettivo Nazionah di Lavoro, the collective agreement signed by trade unions and employers in Chemistry/Rubber/Plastics sector in the early 1970s. Other sectors, such as metal-working have also used it, or have negotiated to use it in their collective agreements. The agreements are normally up-dated every three years and incorporate the most recent version of the ACGIH list.

369 370 371

Directive o n Asbestos. Chemical Agents Directive. Information given by members of the trade unions, in Italy and the TUTB.

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National structures and institutions involved with setting OELs. Until recently there was no national committee/advisory board or other regulatory body established dealing exclusively with the establishment of OELs. The only (historical) example of such a body existed in 1975, when the former ENPI (Ente Nazionale Prevenzione Infortuni National Agency for Prevention of Accidents at Work) issued a provisional list of recommended OELs, which was never approved at national level. ENPI was shut down in 1979, after the National Health Service was installed in 1978. Although historically there was no specialised body at national level dealing exclusively with OELs, there are a plethora of committees and bodies that deal with work environment issues generally, and which may involve OELs. The most important include:372 The National Institute of Occupational Safety and Health (Istituto Superiors per la Prevenzione e la Sicurezza del Lavoro - ISPESL). The Institute is one of the technicalscientific bodies of the National Health Service under the Ministry of Health and it operates on all occupational safety and health matters. In addition to the role of the National Advisory Committee on Toxicology in this respect (see below), the task of proposing exposure limits is addressed by ISPESL, which relies on recommendations by the ILO or EC directives that address occupational exposure to carcinogens and other hazardous chemicals in the workplace. The National Institute of Health (Istituto Superiore di Sanita - ISSj. The National Institute of Health is another technical-scientific organ of the National Health Service. It enjoys scientific, organisational, administrative and accounting independence and is subject to monitoring by the Ministry of Health. It undertakes research, experimental, control and training functions in relation to public health. The National Advisory Committee on Toxicology (Commissione consultiva tossicologica nazionale). Provides information on chemical compounds and their effects on health. The general aim is to draw up guidelines and perform toxicological evaluations of chemicals, mainly for carcinogenicity, teratogenicity and mutagenicity. It is done through an evaluation of scientific evidence available in literature, and other sources, including confidential ones. The intended users are the health personnel of the

Information on most of the bodies described in the following can be found on the following web pages: http://www.ispesl.it/; http://www.iss.i1i'; http://www.inail.it/; httj>://www.iims,it/.

272 Beyond Limits National Health Service and epidemiological researchers. Reports on single chemicals or groups are distributed on request and free of charge.373 The National Institute of Insurance against Accidents at Work (Institute? Nazionale per L 'Assicurazione contro gli Infortuni sul Lavoro - INAIL). Operates under the authority of the Ministry of Labour, managing the mandatory insurance funds against occupational accidents and pathologies. The INAIL has regional and local offices all over the country. The Italian Institute of Social Medicine (Istituto Italiano di Medicina Sociale - IIMS) An advisory body, under the Ministry of Labour, devoted to study and research regarding social diseases and prevention tools. The Permanent Advisory Committee for Accidents Prevention and Occupational Hygiene (Commissione consultiva p&manente per la prevenzione degli infortuni e Vigiene del lavoro). This committee, chaired by the Minister of Labour, monitors the application of legislation, as well as its updating, and is composed of a great number of members regarding all aspects of OHS. The most represented bodies are: the Ministry of Labour, Ministry of Health, ISPESL, Regions and Autonomous Provinces, Trade Unions, Employers' Organisations. In addition, the following institutions are represented by one member each: the Ministry of Industry and Trade, Ministry of the Interior, Ministry of Defence, Ministry of Transport, Ministry of Agriculture, Ministry of Environment, Office of the Prime Minister, INAIL, EMS, National Institute of Health (ISS), National Fire Brigade, National Research Council (CNR), National Body of Standardisation (UNI), Italian Electrotechnical Committee (CEI), National Environment Protection Agency (ANPA). Implementing the EU Chemical Agents Directive and the IOELVDirective. In order to implement the transposition of the EU Chemical Agents Directive and the IOELV Directive made under it, several new committees and working groups have been set up. One was composed of nominees of the various ministries and is responsible for implementation of indicative values in the IOELV Directive. The Ministries of Labour and Industry defined the need for a Working Group with membership of about 25 persons representing wide-ranging interests in order to assist with guidance on the http://www.occuphealth,fi/e/eu/haste/i01 Lhtm, Although this committee still exists formally, according to sources in Italy it has not met for at least four years. Deereta Legislative n. 626 del 19/09/1994 Coordinate con Decreto Legislative n. 242 del 19 mono 1996,

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definition of risk. At the same time, following a request from the Ministry of Industry and associations representing the interests of small enterprises, ISPESL created a national working group organised in seven sub-groups to deal with the production of guidelines on the transposition of the Chemical Agents Directive. It is particularly charged with dealing with the needs of small enterprises in this respect. In addition there is a group of experts designated by the Regions that has also produced its expert, nonbinding guidelines on the implementation of the Directive.375 It seems likely that these guidelines will be approved by ISPESL. A Ministerial Commission is being created by the combined efforts of the Ministries of Labour and Health. Legal status of Occupational Exposure Limits.376 D.Lgs 25/02 implements the Chemical Agents Directive 98/24 EC. It is intended to be integrated with D.Lgs 626/94 which provides for the over-riding approach to regulating systematic health and safety management in Italy (in line with the requirements of the EU Framework Directive 89/391), of which managing chemical risks is seen as one part. Only the OELs from the European Union are legally binding nation-wide. Currently this means that there are only five binding OELs (for lead, wood-dust, vinyl chloride, asbestos and benzene) and no indicative ones. TLVs agreed between social partners are only valid for the sector for which the collective agreement has been adopted. If limit values, established either via the EU or via collective agreements, are higher than those technically achievable, then such transposed/agreed values are considered to be against the law. With respect to the European Union this is generally not a problem, because all OELs based on health and safety Directives are anyway minimum standards and Member States are free to establish better values. The same seems to be the case for sectoral national agreements. If they are higher than those that can be technically achieved, they are legally void. To appreciate the significance of the thinking behind this, both types of values have to be seen in conjunction with the principle of reducing exposure to As Low As is Technically Achievable (ALATA ) that is the theoretical basis of Italian regulatory strategies on hazardous substances. According to this principle, the employer is obliged and the worker entitled, to avoid exposure to chemical agents that can have an adverse effect on health. The principle is regarded as

375

376

Presented at a Conference i n Modena in 2002 (Coodinamenta Tecnico per la Sicurezza net Luoghi di lavoro delle Regioni e deile Provincie autonomie (2002)). This again is information given b y ISPESL, a n epidemiologist from Turin and various trade

274 Beyond Limits an expression of the fundamental constitutional workers' right to health and safety discussed previously. Discussion at national level on how to deal with the obligations arising from transposing the Chemical Agents Directive and the lists of Indicative and Binding Occupational Exposure limit based on this Directive, reflect in particular the concern that binding limit values might threaten the highly valued ALATA principle. For trade unions especially, there is a worry that because Italy's capacity to influence developments at European level is not as great as that of countries with internationally recognised procedures for setting OELs,377 the Italian ALATA principles they cherish may go unrecognised at EU level. According to the trade unions (CGIL/CISL/UIL)"8 therefore, maximum effort should be made to establish at national and European level healthbased OELs in a more systematic way. They argue these health-based values should be developed by independent scientists and should extend to more sensitive groups of workers. They believe their OEL approach therefore covers far more workers than the one generally used by national OEL Committees in other European countries. The unions would not regard most of the so-called health-based values established in other countries health-based at all, and consider that their own approach (ALATA) guarantees much lower exposure levels at the work places. Despite this theoretical position, in practice the trade unions recognise that the process of establishing health-based Europe-wide recognised OELs is very time consuming. They therefore accept (in order to speed up the process for getting OELs at all) for the time being what they call 'technical OELs', or 'occupational exposure action levels'. What is meant by compliance? Based on the transposed European Framework Directive and the obligation arising from the Directive 80/1107/EEC, employers are obliged to assess the risk to workers arising from the exposure to dangerous substances at work. The employer 'is obliged to adopt within the company those measures which according to the particular features of the job, experience and technology - are necessary to ensure the physical and emotional integrity of workers' (Art. 2087 of the Civil Code). Therefore, once the risk has been identified, the only theoretical limitation for the employer when adopting preventive and protective measures (aimed at eliminating or reducing the risk) is technical feasibility. However, the Directive 98/24/EC distinguishes what is required in terms of risk assessment between 'slight' Such as the UK, the Netherlands, Sweden and Germany. This is based on information in 'I Valorie-limite per I "esposizione professionals a Sostanze conceroge', CIGL, 2002 Fiere, Modem.

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risk and other risk categories. The Italian translation of this term - moderate) - has resulted in considerable controversy in Italy over what exactly this means (see below). Enforcement activity. Between 1955 and 1978, the Labour Inspectorate (Ispettorato del Lavoro)m as an office of the Ministry of Labour, decentralised to regional and provincial level, was the main body responsible for monitoring the application of labour legislation and collective agreements and the functioning of social insurance, welfare and health arrangements. In 1978, the Health Services Act (Law 833/78380) instituted the National Health Service structured in Local Health Agencies (L'unita sanitaria locale USL)381 at regional level under the Ministry of Health. In each USL, among the traditional health services (Aziende sanitarie locali - ASL), a unit for Occupational Health and Safety (Servizia di Preveraione e Sicurezza negli Ambienti di Lavoro PSAL) was established. The law gave some of the powers of the Labour Inspectorate to the PSAL. They were provided with regulatory powers on health and safety and enabled them to use these powers in addition to their preventive advisory activities (which were mainly oriented to support trade union actions in worksites based on Art. 9 of the L.300/70).382 The health and safety system was substantially reorganised as a result of efforts to comply with the EU Framework Directive and a somewhat more significant inspection role for the Labour Inspectorate was introduced in the late 1990s. The decree DPCM 14.10.1997 n.412383 identified a few higher risk sectors where control can be undertaken jointly by Labour Inspectorate and the prevention service of the USL for example in the construction industry. PSAL activities include:

http://www.area.fi.cnr.it/guests/prevenzione/capl.pdf. Legge 23 dicembre 1978, n, S33 'Istttuzione delServizio Sanitaria Nazionale'pubbticata sul Supplemento Ordinario delta Gazzetta Ufficiale n. 360 del 28-12-1978. Legge Regionale 17 luglio 1996, n. 26., Riordino del servizio sanitario regionale http://www.regione.marche.it/bur/96/53.2S07neggV2.html L. 20 maggio 1970, n. 300; Norme sulla tutela delta Hberta e dignita dei lavoratori, delta liberta sindacale e dell'attivita sindacale net luoghi di lavoro e norme sul collocamento http://www.dielle.it/Leggi/70-300.htm. Decreto del Presidents del Consiglio dei Ministri, Reingresso dett'ispettorato del Lavoro nell'attivita di vigilanza; http://www.626.cisl.it/doconline/Legislmione/Leggi%20Decreti/Dec%20pres%20consiglio% 20ministri.htm.

276 Beyond Limits

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sectoral prevention plans controls on OHS legislation controls on medical surveillance carried out by the 'Competent Doctor' of the companies examining plans for the removal of asbestos preventive assessment of new activities, plants and work-sites criminal investigations on work accidents and occupational diseases providing information to workers on control activities giving information and training on legislation and authority policies to workers, trade unionists, employers and experts.

There are a number of statistics available on the extent of enforcement activity generally. However, none specifically relate enforcement activities to infringements of OELs. According to sources within the Labour Inspectorate Unit of the Ministry: '. . . data are not systematically collected. Regional Governments, such as in Tuscany or Emilia Romagna) may have databases on USL activities, that may include infringements related to chemicals.' However, such information is not collected systematically or published.

APPLICATION IN PRACTICE The introduction of OELs into the Italian regulatory system is a departure from traditional approaches. It is also a new development that is largely untested in practice. There are major concerns about the implications of transposition for the practice of risk assessment and its monitoring through the inspection activities of the regulatory authorities. Additionally the regulatory system itself is complicated by the role of the Ministry of Labour and Ministry of Health and the agencies under their separate control as well as by the regional variations in practice. In this section we consider some of the implications of this general picture for the practice of inspecting and controlling measures on chemical risks at the workplace level. We start with the structure of the system for inspection and control, followed by an outline of strategies for securing compliance and end with some of observations of participants on OELs and the efficacy of the system. The section is based mainly on interviews with regulatory officials, employer and trade union representatives as well as with representatives of structures created to support employers and workers in health and safety following the implementation of Decree 626.

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The structure of the regulatory system. The National Health Service instituted in 1978 replaced previous employment-based health insurance schemes with a single national system. Reforms brought about by Law 833/1978 divided the management of occupational health into three levels of intervention. At national level, the Central State was responsible for national health planning, laying down uniform health and safety rules and approval of machines and equipment for accident prevention purposes. The Ministry of Health was invested with the powers previously vested in the Ministry of Labour and inspection functions of the Labour Inspectorate were transferred to the USL.384 This was a crucial point of the reform. From 1978 until the adoption of Decree 626, the Labour Inspectorate was virtually absent from the health and safety field. Inspection and control functions normally performed by the Labour Inspectorates in other countries were undertaken by inspectors from local health units (USLs). In addition the Higher Institute for Accident Prevention and Safety at Work (ISPESL) was set up by Presidential Decree 619 of 31 July 1980. ISPESL is managed on a tripartite basis. Its functions are to undertake research and to define criteria for the approval of industrial machinery and equipment. There are 36 ISPESL local departments working with the USLs. There are 19 Regions and two Autonomous Provinces. They are all entitled to adopt health legislation including provisions on health and safety at the workplace. Following the reforms introduced by Act 833 the health system was managed in highly diverse ways across regions. There are many factors that explain this variation at regional level. Among the most important are the varying degree of industrialisation, difference in the labour market, varying strength of the trade union organisations, as well as the political orientation of the regional authorities and the resources available. Obviously the feet that detailed national provisions were never adopted to operate Law 833 fostered even more regional variation. Observers have argued that the implementation of the National Health System gave rise to a double and contradictory effect. For example, according to Pelissero and Carreri (1997: 314): 'on the one hand, to place . . . . under the USL, all the services of prevention, care and rehabilitation induced a global and unitary vision of medicine. On the other hand, the fact that national programme and planning were never completed and USL: Unita Sanitarie Locali, Local Health Unit,

278 Beyond Limits that the Act 833 suffered from some technical shortcomings have given rise to an ever increasing 'regionalisation' of the organisational model. This led to the development of some 21 models of USL based on the regional laws adopted between 1978-1981.' The duties and functions of these services varied. Public hygiene, food hygiene and environmental hygiene could be found in all regions. Fifteen regions however, included developing the function of health protection in the workplace as part of the hygiene service (See Pelissero and Carreri 1997: 314 -316). It has been estimated that between 60 to 67 per cent of USLs provided a specific workplace preventive service. There were also 85 district preventive centres or services set up under the aegis of USLs in some regions. Staffed by a workforce of a little over 5,000 people, they had specialised laboratories for analysing physical and chemical factors and toxicological examinations. Their duties extended both to prevention at workplace and protection of the environment, and their activity was multidisciplinary to a high degree (See Vogel 1993: 308 and 313 In the late 1980s there were approximately 670 USLs operating at the local level, each covering a population ranging from 50,000 to 200,000 persons. At the beginning of the 1990s the National Health Service including the USLs was restructured. One aspect of this process was the requirement of Decree 502 of the 30 December 1992 for regions to reorganise and reduce the number of USLs until broadly, they corresponded to the number of provinces in each region383 (Pelissero and Carreri 1997). The implementation of this article reduced the number of USL to 228 in 1995. Article 7 of the Decree aimed to bring more uniformity to the regional systems as regard to prevention, monitoring, inspection, and health and safety at work. It specified that within the boundary of their competence, the Regions must establish within each USL a prevention department to carry out workplace prevention activities in accordance with Articles 16, 20 and 21 of the Act 833/1978.386 The setting up of prevention departments within USLs as well as the reorganisation of the USLs at provincial level constituted a major change. However, the preventive principles as well as the attributions and functions of these services remained the same. The public health system was still the main structure responsible for prevention activity in the workplace and once again, it was left to the Regions to implement the detailed operation of health reform and therefore capacity for wide variation also remained. 385

Each Region is subdivided into a number of Provinces. These are the main articles concerning prevention activities in the workplace and preventive

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The transposition of the Framework Directive has modified but not entirely changed the involvement of public health structures in OHS. USLs are still provided with the power of the Labour Inspectorate in health and safety. Thus they have regulatory powers in health and safety and are able to use these powers in the workplace in addition to their preventive advisory activities. The Decree 626 provides that the monitoring of the application of the legislation on health and safety may also be exercised by the Labour Inspectorate, which will need to inform the prevention and safety unit of the USL at a territorial level beforehand. It also provides for the Ministry of Labour to ensure adequate co-ordination of all the levels of administration (national, regional and local) involved in the management of health and safety at work and the creation of a regional committee for co-ordination (Art.27) of all the OHS structures. However, in practice in most regions it appears that while the Labour Inspectorate has undertaken responsibilities for enforcing some aspects of the law on the terms and conditions of work and on issues of non-legal work,387 it has not engaged substantially in monitoring or enforcing compliance with occupational health and safety provisions. Nor has it made any substantial commitment to the training or employment of specialist inspectors for occupational health and safety. As we see below, the co-ordinating role of the Ministry of Labour at national, regional and local levels is problematic in practice because of its lack of engagement in operational aspects of the substantive issues involved. The implications of the structure of the regulatory system. The somewhat labyrinthine structure of the regulatory system, and the complicated distribution of responsibilities for policy and practice between the agencies of the Ministry of Labour and the Ministry of Health at national and regional level, are regarded by many as less than helpful for the promotion of a clear strategy on chemical risk. Moreover the dissociation between Ministries and agencies largely responsible for policy from those largely responsible for practice is another obstacle for the operation of strategic aims. The powerful role of the regions in implementation of the law is a further important complication, for although theoretically the Ministry of Labour has authority to implement the law, in practice this authority actually lies with the regions. At the same time, the Ministry of Labour retains a responsibility for much of the liaison between the Italian state and the European Commission on the creation, transposition and application of Directives on health and safety. It is also the architect of the national transposing measures (sometimes with other Ministries). The details of transposition are however the subject of negotiation between the regions and the national level. Constitutionally, the current system reflects It plays a substantial role in policing the illegal employment of immigrants for example.

280 Beyond Limits an approach in which it is accepted that minimum requirements will be defined by EU measures which may be taken further by national requirements and further still by requirements at regional level. This means that in some cases, such as with OELs, there are parallel developments in which national committees at Ministry level define technical policies while at the same time there are committees for consultation between regional and national level engaged in a similar task. Because of the importance of the regions in the application and use of the law, these regional committees and their recommendations play a significant role both technically and politically. In addition, because regions may introduce more rigorous measures than those required either at EU level or nationally and because there is enormous discrepancy between them, in terms of their prevention resources and policies, there is good reason to suppose that widely different standards may result. In practice, given the strong lobbying at national level by interest groups concerned with the costs of compliance, the likely practical and political result of the possibility of greater stringency at the regional level is greater pressure towards minimal standards at national level. In the case of OELs it is too soon to observe such outcomes as the process of their definition is still underway. Nevertheless, the text of the national provisions transposing the Chemical Agents Directive has been the subject of some controversy. There has been discussion concerning the retention of the substance of previous Italian requirements to reduce risks as low as is technically possible.388 But the main issue of debate seems to have concerned the definition of the level of risk at which employers are required to demonstrate that they have taken action. Clearly action is required at levels of high risk. The problem occurs in the terminology used to define the level at which employers are expected to assess risks taking into account the existence of OELs. This implies a requirement for monitoring and measurement that employers' organisations, especially those representing small enterprises, argue will place unacceptable economic burdens upon their membership. As a result they have focused on the meaning of the Italian translation of the term 'slight risk' that is used in the Directive, arguing that such onerous requirements on risk assessment do not apply to situations with such a level of risk. At the same time, trade unions and prevention specialists fear that if the level of risk at which action needs to be taken is set too high, then many workers will face unacceptable risks to their health. They are concerned that workers will experience a lower level of legal protection from their employers than that During a preparatory phase in transposition the principles of these articles were apparently inadvertently dropped. They have however subsequently been effectively reinstated with requirements on duty holders to maintain previous levels of prevention practice in relation to chemical risks.

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to which they are entitled as a constitutional right - and which was provided to them under previous legislation in which all employers were required to reduce risks to levels that were as low as technically possible. This has therefore become a political issue that has been fuelled by an issue of translation in which the Italian transposition of the Directive's requirements implies that action is not required if risks are 'moderate". As we have noted, there are both Ministerial committees and those at regional level that are attempting to develop guidance on these issues. There is for example a technical committee with representation from the Ministries of Labour and Health and their agencies that is responsible for the implementation of EU indicative values. At the same time there are several technical working groups established by the Ministry of Industry and the Ministry of Labour, one of which is charged with defining risk. Parallel to these committees there are regional ones, indeed, by the time the technical working group on defining risk had held its first meeting the regions had already produced their guidelines. To avoid creating arbitrary distinctions between situations of 'low' or 'moderate' risks in terms of levels of protection required, the agreed aim of the guidelines from all these committees is to achieve a high protection of workers without the need to measure levels of chemical pollution in the workplace. This means producing methods which allow effective risk assessment to be undertaken to certain levels that does not preclude measurement but does not make it an essential requirement of the process. This is why the retention of former legislative principles of reducing risks to as 'as low as technically achievable' is regarded as important since such principles avoid imposing demarcation lines between situations in which risk is legally defined as requiring certain types of action and those where no action is required. Strategies for securing compliance. The different government ministries involved and the devolution of authority to the regions makes for a complicated system that results in more than a degree of obfuscation of strategy, confusion for its intended targets and many opportunities for debate and disagreement concerning both the aims and application of strategies on chemical risks. Interviews with officials with responsibilities for securing compliance from different USLs in regions in the north of Italy389 conveyed a general picture of practice in which Although there are great differences in the role of the prevention departments in USLs in the south of Italy and those of the north, it is unlikely that officials from USLs in the regions of the south of

282 Beyond Limits the traditional requirement to reduce risks as much as was technically possible was preferred to a system in which OELs played a more pivotal role in determining the nature of compliance strategies. As the transposition of the relevant EU Directives on chemical risks is a very recent development and their operation still largely under discussion, this is perhaps not surprising. However, it also reveals that inspectors share some of the concerns about the new system. That is, they are worried that the existence of an OEL will act negatively on the will of some employers to reduce exposure to as low as technically possible, even when they have the capacity to do so. In this respect they are concerned that the existence of an OEL for particular substances will reduce the discretion of the inspector and especially his/her authority to require employers to reduce exposures to levels the inspector feels to be technically feasible. Moreover, there is a strongly held view that a 'one value* OEL regardless, of the documentation that might accompany it, will be interpreted as a 'safe level', and that this will be exacerbated by the definition of risk in the legislation. It is felt that the use of terminology such as 'moderate' risks as levels below which monitoring activities may not be required, will be interpreted in ways which will effectively mean that employers will believe there is no requirement for any preventive action to be taken in such circumstances. Again this is perceived to make the inspectors' tasks of advising and persuading employers to adopt best practice approaches to prevention more difficult. All these concerns were shared by workers' representatives and trade union officials, as well as by the representatives of unilateral and bilateral OHS information and advisory agencies interviewed. While these individuals all had different perspectives resulting from their particular roles in occupational health and safety, they were nevertheless broadly of the same view regarding a perception of the legislation as requiring an 'all or nothing' response that was based around a rather arbitrary definition of risk, which in practice would do little to encourage many employers to reduce risks to levels they would be technically and economically capable of achieving. This of course is the obverse of the concerns also expressed by organisations representing the interests of the owners of small enterprises, who fear that those enterprises that fall into the higher risk category will by definition be required to invest in monitoring procedures regardless of the realities of the risks actually experienced at their workplaces.

Italy would have adhered to a more rigorous or technical use of OELs in their inspection strategies. It is widely accepted that the structure, resourcing and practice of inspection and control in OHS is southern Italy is generally much weaker and more erratic than that found in the industrialised regions of central and northern Italy. The interviewees all came from USLs in the northern regions and therefore probably represent 'best case' practices.

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Inspectors' approaches to seeking compliance in enterprises in which chemical substances with OELs are in use are based around first checking the extent to which risks had been assessed through the examination of documentation. They then may consider the features of the workplace such as for example, its design, the use to which it is put, work practices, the quantities of substances used or released and the engineering controls that are in place to reduce exposure. If the inspector is not satisfied with the existing arrangements s/he may require the employer to present a prevention plan in which information on what practices, procedures or designs are to be introduced to assess and control risk. The requirement for a prevention plan/risk assessment could include providing information on exposure levels to substances with OELs, that would mean employers would need to measure (or contract someone to measure) chemicals in workplace air. Inspectors have the power to require such measures and/or to supervise their collection or undertake the measurement themselves. However, generally measurements are not required. Priority is given to inspection activity in workplaces where actions are most likely to be needed. Here it is normally not necessary to measure airborne contaminants in relation to their OELs since it will be obvious that OELs are being exceeded or there are other obvious problems that imply they will be exceeded. Recent strategies in some regions have resulted in more targeted inspection in which particular sectors and processes are studied in greater depth. This has been made possible by the recognition that the basis of the Italian economy is the structured network for production amongst small enterprises engaged in similar tasks and using similar processes that characterise many industrial sectors and which is evident at local levels. OELs and measurement of chemical contamination of workplace air are relevant to these strategies. Generally however, because there is an association between the notion of OELs as legal requirements and the formal enforcement role of inspectors, they are not much used in targeted strategies. The emphasis of the USL inspectors is to develop strong working relationships between employers, workers and their representatives, the regulatory authorities and other participants in OHS at local levels, hi these relationships, which are predicated on developing trust between participants, USL inspectors are at pains to project their advisory role rather than that of formal enforcement. Examples of this approach at local sectoral levels include the involvement of inspectors in projects on wood-dust and on lead and other toxic substances in ceramics, in work in the meat industry and in asbestos removal. Here a more holistic

284 Beyond Limits approach to control is sought in which for example, engineering control, control at source or (as in the case of wood-dust) controls built into the manufacture of machinery before it enters the workplace (and thus, specification standards), are the focus of discussion, rather than compliance with OELs. In some of these examples an agreed protocol for good practice at local (district) level, to which employers and other participants adhere in workplace practice, is the desired outcome. Here again, the perception of the OEL as a measure that implied a fixed environmental standard to be achieved regardless of variations in workplace realities, is seen as too rigid to allow the flexibility of practical control solutions to the exposure of individuals that could be achieved through agreeing a general protocol for good practice in relation to specific processes. In this approach, inspectors recognised that there are always likely to be some employers who Ml to participate or comply with such a protocol. However, they believe that if a critical mass of enterprises in a local area have agreed to implement a protocol concerning a particular issue such as the use of wood-working machines for example, the peer and economic pressure that this has on all the relevant firms in the area is such that it is more likely to achieve overall improved OHS performance than would otherwise be possible. It also allows the bad performers to be more readily identified and for more formal enforcement techniques to be used against them. Moreover, in the case of subsequent legal proceedings such protocols may be helpful in informing legal decisions about practicable prevention practices for the sector. Amongst the USL inspectors as well as among other participants interviewed there was a perception that exposure limits were more of a prominent issue in the debates of the 1970s than they have been in more recent times. For example, pressure for the adoption of the ACGIH list into the collective agreements in certain sectors such as the chemical industry dates from this period. Some inspectors also expressed an impression that less rather than more measurement of workplace air pollution in relation to OELs was currently conducted than had been previously. It was further suggested that the increased role of OHS consultants resulting from the requirements on prevention services that were introduced by Act 626 had not really contributed to greater facilities for measurement since many such consultants had neither instruments nor skills to undertake proper occupational hygiene practice. Therefore, although it was felt that one of the effects of the measures to transpose the Chemical Agents Directive may be increase the pressure to require some employers to undertake monitoring, the extent to which commercial prevention services had the capacity to do so was doubtful. It was feared that the effect of this would be to create a double standard - one for those employers who could afford to take appropriate monitoring actions either themselves or with the aid of qualified and competent prevention services - and another for the rest.

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Interviews with workers' representatives and their trade union officials tended to bear out the impressions given by the USL inspectors concerning the use of OELs. For example, workers' representatives believed that national level OELs were a necessary means of alerting participants to the existence of a problem that required attention. Thus it was suggested for example by workers' representatives from the metal and chemical manufacturing sectors, that in their experience the main value in the adoption of the ACGIH list in collective agreements, was that it drew their attention to substances that may be in use in their workplaces and for which they needed to obtain appropriate information. The worker representatives from these sectors who were interviewed were unaware of any widespread use of OELs in enforcement, despite their inclusion in collective agreements. In contrast, they were able to point to numerous examples of their own experiences in which the existence of the list had prompted them to seek information on particular substances in use in their workplace or about to be introduced there. They were able to give further details of the results of the follow-up to these actions in which, by negotiation, employers had agreed to modify processes or substitute 'safer" constituents. They spoke of USL inspectors being involved in separate discussions with the employer on the same issues in some cases but did not perceive measurement and monitoring of the relevant OELs to have been of central interest. The strong impression from these interviews was that the role of OELs was somewhat peripheral in the daily realities of the worker representatives' experience. Subjective perception of risk was far more significant. It was this subjective perception that instigated bargaining for better working environment or changes in work organisation, not the technical measurement of risk. They also pointed out that since inspection only reaches a minority of workplaces, the trade union role extended beyond the confines of the large workplaces (in which there was strong worker organisation on health and safety) to smaller, less well-organised workplaces in the same sector in which trade unions could bring pressure to bear through the adherence to the principles enshrined in the collective agreement. In this sense they provided another side to strategies described above in which the USL inspectors sought to achieve agreed protocols on OHS matters which would have more widespread effect in the sectors in which they were established than could be achieved through inspection alone. Thus the worker representatives confirmed, from their own perspective, the USL inspection approach. It is noteworthy that from either perspective, OELs do not play a prominent role. They are not a main focus for compliance strategies even when such strategies deal with subjects such as reducing risk from exposure to substances such as wood-dust which have featured prominently in international debates on setting and using OELs.

286 Beyond Limits

CONCLUSIONS

The implementation of the Chemical Agents Directive poses some major challenges to the Italian system. It is not yet clear how these will be resolved. Transposition at the national level has engendered considerable debate. At the local level there is little sign of compliance strategies that place OELs in a central position, either from duty holders, workers and their organisations or the authorities for inspection and control. While representatives of all these players have quite strong views on the national debate, it is not obvious how these relate to local level experience. These are concerns on the part of smaller enterprise owners over financial implications of measurement. Trade union representatives and inspectors have concerns that setting both single limit OELs and action levels according to the proposed definitions of risk will, in practice, have a negative effect on the willingness of many employers to follow best practice and reduce exposures to as low as technically possible. There seem to be some major questions over what is being achieved by the introduction of the EU measures on OELs into the Italian system. Trade unions argue that such limits are not the truly health-based values they seek. Employers' organisations fear that their adoption will require their members to invest heavily in the use of expertise to monitor workroom air which, in the main, will be well within the relevant OEL. Inspectors, trade unions, and OHS professionals are all concerned that the national definitions of risk that are set to determine the extent to which duty holders are required to take action will have the negative effect of allowing many employers to believe they need do nothing, which in turn will make it harder for inspectors to require that they reduce risks to as low as technically possible. OELs probably have some value at national or sectoral level as indicators of risk associated with exposures to some substances. As such they are useful in raising awareness of the possible need for action at local level. But at the local level, practical realities are such that improvements in OHS management are normally effected by means that neither require, nor overtly involve, the use of OELs. Therefore it is arguable that the connision and obfuscation introduced by the current state of the transposition of EU measures on chemical risks, could well be greater than the benefits such measures seek to achieve. However, this also needs to be seen in the context of the general features of the Italian system. One of its characteristics for example, is the great variation between regions.

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Since practices described by interviewees in the present study were all drawn from the industrialised northern regions - which are widely acknowledged as being comparatively well developed in terms of OHS provision and practice - they are not typical of Italy as a whole. Indeed the absence of input into the present study from representatives from regions in the South is largely a reflection of the lack of resources for health and safety in these regions. It further reflects their lack of engagement in issues at national level such as the development of guidance on transposition of the Chemical Agents Directive. It may be that national measures therefore do serve as a useful guide. They may not have a great deal to offer regions in which good practice in OHS prevails, supported by relatively well resourced prevention departments of USLs, and bilateral information and advice structures, as well as by informed trade union representatives. Nevertheless, they are perhaps a useful baseline for the country as a whole since the law allows regions to develop better practices but theoretically at least, it does not condone the implementation of lesser ones.

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8

THE NETHERLANDS

INTRODUCTION The Dutch chemical industry is not as large as that in Germany, the UK or Italy, however in relation to the working population of the Netherlands it not insignificant. Nor of course is exposure to hazardous chemicals limited to employees in the chemicals industries, as we have pointed out in previous chapters on the other countries in the study. Indeed, the Netherlands was chosen as one of the countries for more detailed study because its policy on regulating the management of chemical risks at the workplace is widely held to be highly developed and innovative. It is a policy that has developed as a result of a long-standing and active interest in improving the work environment in relation to the use of chemical substances that has been shared by trade unions, industry and the state. Despite (or perhaps because of) such engagement, according to the European Foundation's Third Survey of Working Conditions, Dutch respondents generally thought themselves slightly less well informed about the risks resulting from the use of materials, instruments and products at work than the average for the EU 15.390 At the same time they regarded themselves less exposed to breathing in vapours, fumes dusts or dangerous substances than the average for the EU 15 as a whole and less likely to handle dangerous products or substances.391 73 per cent of Dutch respondents regarded themselves as fairly well or very well informed about the risks from their use of materials instruments or products in their job compared with 76 per cent of respondents in the EU 915) countries overall. 14 per cent of Dutch respondents thought they were exposed to breathing in vapours, fumes dusts or dangerous substances (compared with 22 per cent of the EU 15 respondents as a whole) and 11

290 Beyond Limits Special features evident in the approach to both setting and using OELs include: -

involvement of trade unions and employers" organisations and representatives of the state a relatively long history of engagement hi standard setting extensive arrangements to distinguish between health-based criteria and the use of economic and technical considerations to agree limits.

At sectoral level the Dutch approach to chemical hazards is distinguished by the particular prominence of the debate on substitution and the strategies to achieve this in certain sectors, as well as by the recent emphasis on the use of convenanten (covenants) to set agreed sector specific targets for improvement of the work environment - which in some cases, include agreement to improve on OEls. At workplace level several features have a bearing on the approach to dealing with chemical hazards. They include: -

statutory requirement on employers to contract with occupational health services to provide them with expertise in risk evaluation and control the role of workers' participation through works councils in arrangements for health and safety strategies of the labour inspectorate to promote and support a systematic approach to occupational health and safety management.

To understand the significance of all these developments for the role OELs play in strategies to achieve compliance and their relationship to features of the wider regulatory system, it is necessary to consider a little of the context in which they occur. This means outlining the regulatory framework within which OELs are established and used and some of the political and socio-economic background to its recent development. We therefore begin this chapter with a brief overview of relevant elements of the Dutch approach to regulating the work environment before turning our attention to the more specific issue of the role of OELs in the process of managing chemical risks. Here we evaluate the significance of the above features of the Dutch approach to the management of chemical risks and also take into account the impact of recent shifts in the politics of health and safety in the Netherlands.

per cent said they wsre exposed to handling dangerous products or substances compared with 16 per cent in the EU 15 sample as a whole.

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THE INFRASTRUCTURE AND PROCESSES INVOLVED IN SETTING

OELs Regulatory system and responsible bodies. The responsibility for establishing occupational health standards lies with the Ministry of Social Affairs and Employment (Ministerie van Sociale Zaken en Werkgelegenhei)Jm Within the Ministry, the Working Environment Directorate of the (Directorate-general Working Environment and Social Security (Directoraat-generaal Arbeidsomstandigheden en Sociale Verzekeringen (DG ASV) ) is responsible for health and safety including occupational exposure limit values. In the Netherlands, working conditions are regulated under the Working Environment Act (Arbeidsomstandighedenwet - Arbowef9*), which is a framework act on the basis of which further decisions and regulations can be made.394 Such regulations can be found in the Occupational Decision (Arbobesluit 199719i) and the Occupational Regulation (Arbeidsomstandighedenregeling 1997 - Arboregeling 199739S). The legal basis for establishing OELs or MAC values as they are called in Dutch (Maximum Allowable Concentration or Maximaal Aanvaarde Coneentraties) is laid down in Article 4.9 and 4.16 of the Arbobseluit. The values themselves are found in: -

Bijlage VI behorend bij artikel 4.19 eerste lid, Lijst van wettelijke grenswaarden op grand van artikel 4.9 van hetArbeidsomstandighedenbesluif7 — Bijlage VIIbehorend bij artikel 4.20, eerste lid, Lijst van wettelijke grenswaarden voor kankerverwekkende stoffen op grand van artikel 4.16 van het Arbeidsomstandighedenbesluit

http://home.szw.nMralex/dsp_index.cftn. Wet van 18 maart 1999, houdende bepalingen ter verbetering van de arbeidsomstandigheden (Arbeidsomstandighedenwet 1998), Staatsblad No. 184 f http://www.xs4all.nl/~wilcodeb/arbol99S.html This is the Dutch legislation that implements the European Framework Directive. Besluit van 15januari 1997, houdende regeh in het belong van de veiligheid, de gezondheid en het welzijn in verband met de arbeid (Arbeidsomstandighedenbesluit: Staatsblad N° 60 I http://m.osha.eu.int/content/network/szw/docs/arbobesluil'wijzdging_09_mei_2000.pdf. Staatsblad 1997, IT 631 htrp://nl.osha.eu.int/contenl^network/szw/docs/arboregeling/arboreg_l.pdf. http://nl.asha.eu.iat/contenfnetwork/szw/dacs/grenswaarden.pdf.

292 Beyond Limits -

Bijlage 6 behorend bij beleidsregel 4.2 -1 Arbobesluif""

Occupational Exposure Limit Values are established through a three-stage consultation procedure involving three main institutional consultative structures: -

Dutch Expert Committee on Occupational Standards (DECOS).399 A subcommittee of the Health Council of the Netherlands (the independent scientific advisory body for all Ministries dealing with public health issues400 *" 402 M3) since January 1994, The DECOS-Committee informs the Ministers of Social Affairs and Employment of the harmful consequences of exposure to toxic substances in the air in the workplace. The members of the DECOS are experts from research institutes, universities, ministries and industry, who participate in the Committee on a personal basis.

-

Subcommittee on MAC values of the Social and Economic Council."* Composed of: six employers' representatives, six employees' representatives, one independent member (chairman), two advisory members (from DECOS), and six ministerial representatives. In principle, the Sub-committee meets every month.

-

Social and Economic Council (Sociaal-Economische Raad - SER).m m The Dutch government's main advisory body where social and economic matters are concerned. It is a tripartite body, comprising employers' representatives, workforce representatives and crown-appointed members (economic, financial, legal and social experts appointed as independent members by the Head of State and the Cabinet).

http://www.fcv.nl/702werkgeld/arbo/themas/gevaarlijke-8toffen/7staffen.html. http://www.gr.nl/overig/standing%20committees/DECOS.htm. http://www.gr.nl/engels/heaIm%20council/Mstory/frameset.htin. http://www.gr.nl/engels/healm%20eouncil/mission/ftameset.htm. http://www.gr.nl/engels/health%20council/domain/frameset.htni. http://www.gr.nl/engels/health%20council/organization/framesethtni. http://www,ser.nVoverdeser/default.asp?desc=connnissies_10_5. http://www.ser.mYoverde8er/default.asp?desc=en_index, http://www.ser.nl/overdeser/default.asp?desc=overdeser_mac_waarden_inleiding.

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OELs are confirmed by and published by the Ministry407 and where relevant, become legally binding as a result. The Labour Inspectorate, as part of the Ministry, is responsible for surveying and enforcing the OELs."08 Character of OELs. The Netherlands has two types of MACs409 4ro "" m : legally binding and administrative (non-legally binding) OELs (Feron 1994). Both take account of socio-economic feasibility. Binding limit values are established for both noncarcinogenic and carcinogenic substances. Administrative values are only established for non-carcinogenic substances. A MAC value is defined as time-weighted average over an eight-hour period. Substances which can easily be absorbed by the skin are assigned an 'H'. For these substances, additional protective measures have to be taken. Specific rules apply to respiratory dusts and fibres. Short-term exposure limit values are established for certain substances for a 15 minute period (up to ten times the MAC value for non-carcinogenic substances and up to two times the MAC value for carcinogens). In addition, some substances are assigned a ceiling value ('C'), which should not be exceeded at any time. The MAC values are expressed in mg/m3 and established at a temperature of 20°C and a pressure of 1013kPa. Procedure for setting of OELs.4" ni 4l5 Until 1977, the US ACGIH TLV list was used in the Netherlands. In 1978, the Directorate-General of Labour of the Ministry of Social Affairs and Employment (MS AE) published the first official list of MACs, which was similar to the ACGIH TLV list of 1977. Since 1978, new MACs and changes in existing MACs have been established in the Netherlands according to the following three-step procedure: -

407 408 409 410 41

'

412 413 414 415

In the first step a scientific evaluation of the data on the toxicity of the substance is made by DECOS. This evaluation should lead to a draft report for a healthhttp://www.gr.nl/overig/standing%20committees/DECOS.htm. http://www.niinszw.al/Documenteii/Iiiformatie/Arbo/arbeidsinspec/arbeidsmspec.htm. http://www.bbzmv.nl/arbabvi.htm. VJ. Feron: op cti. http://nl.osha.eu.intj'content/network/szw/docs/grenswaarden.pdf. http://www.bbzrhv.nl/arbobvii.hmi. http://www.industox.nl/MACcie2000/sld005.htm VJ. Feron: op. cit. http://www.minszw.nl/Documenten/Nieuws/nieuwsberichten/pbOO/00215.hmi

294 Beyond Limits based recommended occupational exposure limit value (HBR-OEL), using the no-observed-adverse-effect level (NOAEL) approach in combination with an "uncertainty (or safety) factor' (UF). Draft recommendations of DECOS are published as soon as the Committee reaches consensus. In this way, third parties are given the opportunity to submit comments on its content. The deadline for comments is approximately three months. The Committee takes the comments into consideration in establishing the definitive advisory report. This first step is only performed for legally binding OELs (MACs). For legally non-binding, administrative OELs, the Social and Economic Affairs Council uses values and data from other countries (e.g. ACGIH) as the basis for the second step.4'6 - In the next phase of the three-step procedure, the health-based recommended exposure limit is assessed for technical and economic feasibility by the MACValue Sub-Committee of the Social and Economics Affairs Council. Based on the results of this study, the Council either advises the Minister and State Secretary for Social Affairs and Employment to adopt the health-based recommended exposure limit or it recommends a different value. — In the third phase, the Secretary of State determines and publishes the limit values either as legally binding values or non-binding administrative reference values. For substances that are classified as carcinogens Category 1 or 2 by the European Union (Directive 67/548/EEC) or by the DECOS-Committee and which, in addition, probably also have a genotoxic effect, a risk evaluation is carried out by the Committee. At the request of the Minister of Social Affairs and Employment, the committee derives socalled health-based calculated - occupational cancer risk values (HBC-OCRV) for these substances. The HBC-OCRV enables the calculation of dose levels and air concentrations associated with reference cancer risk levels for the occupational situation. In its reports on individual genotoxic carcinogens the Committee presents the concentration levels associated with excess cancer mortality at levels of 4 per 1000 and 4 per 100,000 as a result of working life exposure. To estimate the additional lifetime risk of cancer in humans exposed at the workplace, i.e. to calculate the HBC-OCRV, the committee assumes that workers are exposed five days per week, eight hours per day, 48 weeks per year for 40 years. They are expected to inhale 10m3 of air during eighthour working day. This advice also results in a legally binding MAC- value (see below).

Information provided by a member of Health Council.

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Discussion at national level: theory versus practice. Several issues have been prominent in national level debate on OELs in recent years. In common with experience in some other countries, a major criticism of the current system is that for the majority of the substances dealt with at the workplace, no exposure limit value exists at all. For others, the basis on which their OELs have been established is too old. A large number of current OELs were adopted Scorn the ACGIH list of Threshold Limit Values in the 1970s (around 300 substances - these values are currently under review). There are studies indicating that for more than 10 per cent of the over 650 entries in 2000 the OEL was too high from a health protection point of view, with deviations ranging from a factor of 2 to 250. For around another 100 substances the toxicological database was judged to be too poor to recommend a health-based OEL. Another criticism is that the complete procedure starting from the inclusion of a chemical in the working programme of DECOS to the official publication of a new MAC value by the Ministry of Social Affairs and Employment takes too long - an average of three to four years per substance. In addition, the simultaneous exposure of workers to a variety of chemicals is not taken into account. The toxicity of a mixture is not only determined by the toxicity of the individual compounds but also by combination effects. Traditionally, toxicological studies for the assessment of hazards to health, as well as the setting of such standards as TLVs and MACS, have focused on single compounds. Other factors which are not really considered when establishing OELs in order to keep the whole procedure as simple as possible are: -

-

longer (or shorter) working days than those on which the standard is based differences in reaction that the human body may display depending on whether the exposure took place during the daytime or at night (these differences are of relevance to shift work, for example, but would severely complicate the method) gender or age aspects (despite certain protective measures for pregnant workers or young people).

Therefore, the safety that MAC values appear to offer is considered to be to some extent illusory. As one consequence of the weakness of the existing system, negotiations between the trade union confederation, FNV and Dutch employers resulted in an agreed framework on maximum acceptable occupational risk levels for non-substitutable carcinogens, values that are now applied across the board to materials in the Netherlands. For the trade unions, the agreement meant 'getting their hands dirty' as they had to accept a specific risk of fatal disease incidence among workers involved

296 Beyond Limits (Wilders 2002). However, the agreement had the advantage of replacing the previous, ad hoc substance-by-substanee approach to carcinogen control in the Netherlands and produced recommendations for limits that are stricter than those promulgated by other agencies. Based on this agreement between the social partners, the government asked DECOS to provide their future recommendations with two time-weighted average limits for the carcinogenic substances under consideration: one based on a residual risk of 10"6 fatalities/year and one based on 10"4 fatalities/year.

POLITICAL AND LEGISLATIVE CONTEXTS 417 The organisation of Dutch society and its economy has for many years been considered to be strongly corporatist in character with little inclination to formalities and bureaucracy. Its present day version, the so-called poldermodel or overlegeconomie (Consultation Economy)418 is based on ongoing processes of consultation and negotiation between the social partners at different levels and between the government and the social partners at central level. This form of corporatism has in the past recognised the primacy of collective bargaining at the sectoral level. In theoretical terms, it has been represented as bargained corporatism characterised by positive-sum strategies, resulting in a large measure of consensus and a trade off between economic and social policy objectives (Crouch 1994). Thus, the role of bipartite and/or tripartite agreements to elaborate or complement legislation or to avoid statutory regulation is prominent in the field of industrial relations and labour law. Implicitly, collective bargaining agreements are framework agreements, creating room and latitude for interpretations, adjustments and elaboration at the company level. This concept of tailor-made policy has pervaded OHS legislation and the means by which it is enacted. The national Socio and Economic Council is a central level important structure within which the corporatist approach to health and safety matters is undertaken, with membership including representatives of the larger confederations of employers and workers and a special committee on OHS. A subcommittee of the Council deals with setting OELs.

This section is largely based on Poptna et al in Walters (ed) (2002). On the Dutchpotdermodel cf. Visser and Ilemerijck (1997). The question remains however if the Dutch system is really a distinct 'model'. Other countries, e.g. Denmark, share many of the Dutch characteristics.

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Parallel to this corporatist approach, was a highly developed system of social welfare in which, from 1967, the principle of risque social has been used in preference to risque professionel in disability and absenteeism benefits. In the mid 1980s alarmed by the escalating economic cost of benefits, the Dutch government embarked on a reform of the social security system. The reforms included cut backs on social security expenditure, with the dual purpose of both contributing to the government's efforts to reduce state expenditure and to serve as an incentive to increase labour participation rates. The policies behind these attempts to reform social security have also driven parallel reform in the regulation of preventive OHS management, such as the introduction of risk assessment and the role of occupational health services in undertaking assessment and in advising employers on preventive options.*19 Employers are expected to have an incentive to improve the work environment in order to avoid higher premiums or to reduce financial risks related to high rates of absenteeism and disability. Greater neo-liberal emphasis within these strategies has been the result of recent political changes in the country and the role of the market and of voluntary initiatives have been emphasised in parallel with further withdrawal of the state from direct engagement with regulating the work environment. Legislation. The process regulation that characterises modern Dutch health and safety legislation begins with the Arbeidsomstandighedenwet (Work Environment Act, WEA 198
They were also of course influenced by developments at Hie European level, in particular the thinking behind the Framework Directive 89/391.

298 Beyond Limits HSW Act 1974 in the UK and the Robens approach underpinning it.420 It was therefore a framework Act with detailed Safety Regulations that had formed part of the 1934 Safety Act left in place (somewhat at odds with the general character of the new Act and the underlying principle of self-reliance). It also set up the tripartite Arboraad (Work Environment Council), within the Social and Economic Council and the powers of works councils were expanded in the area of OHS. The WEA has been modified subsequently. The first and most significant reform in 1994 transposed the requirements of the Framework Directive' provisions on risk assessment. The main idea of the 1994 version of the WEA was to put greater emphasis on a systematic approach to OHS. The employer's responsibility to develop and pursue an OHS policy was extended by a requirement that such a policy be based on a thorough risk assessment and be moulded into a plan of action. In the case of risk assessment, amendments were made to Article 4 of the 1980 WEA. As of January 1 1994 Article 4, Section 1, stipulated: 'In pursuing his general business policy the employer must aim this policy at a maximum possible safety, a maximum possible protection of health and the promotion of the well-being of the employee within the enterprise or the institution; this policy comprises the means and the way to reach this goal, it lays down the distinct powers and responsibilities which ha this respect rest with the persons who are employed by the employer, and should be based on a sound written-down assessment and evaluation of all hazards which the work involves on the safety, the health and the well-being of employees. These hazards include, among other things, the hazards of tools, machines, devices and other aids regarding the work, substances or preparations that are being used and the arrangement of the workplace. The assessment and evaluation should also include the hazards that cannot be avoided, as well as the hazards for groups of employees that can be considered extraordinary. Besides, it should be laid down which measure will be taken in relationship to the hazards referred to and the relationship between these, in accordance with that stipulated in Article 3.' (our italics). Article 18 of the WEA makes it mandatory for employers to call in the support of the (external or internal) occupational health services (Arbodienst) in drafting a risk assessment and evaluation. It requires firms to contract certified multidisciplinary OHS services to support or provide risk assessments, monitor company OHS and absenteeism policies and monitor shop floor conditions. This was one of the major innovations in the See Chapter 4 for an outline of this approach in the UK.

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1994 legislation. A limited number of the functions provided by OHS services are mandatory. As well as risk assessment they include for example, requirements to provide care for sick employees, to perform medical examinations and to be available for consultation by employees. However, poor quality of OHS services and their lack of independence have been a controversial issue ever since the system was introduced in 1994. This is to a large extent attributed to the commercial setting in which the OHS services operate.*21 The Ministry of Social Affairs and Employment further promoted the systematic approach to OHS by a publication on OHS and absenteeism policy,422 which introduced the 5-W planning circle.423 The ministry also promoted the development of guidelines on OHS-management, the so-called NPR 5001 (NNI 1996). It was expected that companies complying with the NPR 5001 could look forward to a more relaxed attitude of the Labour Inspectorate towards inspection policy. Further reform was introduced in WEA 1998 when administrative fines were introduced in the revised Act (Arbeidsomstandighedenwet 1998), as a new enforcement tool for the Labour Inspectorate (Arbeidsinspectie). They can be imposed for negligence of administrative obligations, such as the absence of a risk assessment or a plan of action (failure to make an inventory of dangerous substances or failure to produce adequate evidence of monitoring in relation to OELs fall into this category), failure to report severe accidents, shortcomings in supplying information to employees or the absence of a contract with an OHS service to undertake the mandatory tasks of these services.

Trade unions and labour inspectors, frequently claim that employers do not assume the responsibilities required of them by this system. They also criticize the lack of independence of the OHS services, pointing out that in reality, the position of these services within firms is precarious, since employers can easily switch to another service once their contract has expired. The pressure on them to do what employers require of them is therefore considerable and their independence reduced as a result (Popma et al 2002). There has also been criticism of the Dutch system from the European Commission essentially because of its emphasis on external provision of competent services. As a result, new requirements that give employers greater discretion about whether they continue to contractwith the Arbadienst or provide alternative arrangements for competent support will be introduced from July 2005. Arbeidsinspectie, Arbo- en verzuimbeleid, publikatieblad P-190, later reedited into Arboinformatieblad I. Willen, weten, wegen, werken, waken (to want, to know/assess, to weigh/plan, to work, to monitor).

300 Beyond Limits Higher fines result from violations of safety regulations, such as lacking protective measures or exposure of workers to dangerous substances. If the employer violates one of the obligations of the WEA for the second time within a period of 24 months, the Labour Inspectorate may increase the administrative fine up to 50 per cent of the original amount. If the employer still does not observe the obligation, the Labour Inspectorate may close down some or all activities of the company or the employer, in person, may be prosecuted. The Public Prosecutions Department (Openbaar Ministerie) may impose imprisonment of six months.424 The Inspectorate may stipulate the manner in which general provisions and technical regulations of the Working Conditions Act must be complied with in practice and may order the cessation of dangerous activities (right of summary enforcement). Apart from this, employees themselves are also entitled to discontinue an activity in cases of imminent serious danger where it is not possible for the Inspectorate to act on the matter in time. In such cases the employee concerned must then inform the Inspectorate of what has happened. In order to monitor compliance with the Working Conditions Act, the Inspectorate visits premises, with or without prior announcement. Inspectors may also be requested to make such a visit by a trade union, or the workers' representatives within an enterprise. In most cases, the Labour Inspectorate will first summon the employer to comply with the obligations (eis tot naleving) before imposing an administrative fine. Only in severe violations of the obligations of the Working Conditions Act, will the Labour Inspectorate immediately impose an administrative fine. The theoretical underpinning of Dutch provisions on the control of chemical risks at work is found in guidance issued under the Working Conditions Act called the 'Strategy of Industrial Hygiene,' based on the notion of achieving effective prevention of exposure to chemicals. This implies taking measures to reduce the exposure that ought to result in the absence of health hazards and nuisance. The key objective of the strategy is to reduce exposure by introducing measures as close to the source of pollution as possible (ventilation systems for example). Companies are obliged to give evidence, by means of a risk assessment, that the situation at the workplace does not harm the health of employees. The risk assessment consists of the risk inventory and risk evaluation. Until the change of the lawn in 2005 an OHS service was required to undertake the risk http://www.andersenlegal.com/resource2.nsfvAttachLU/IntroductiontoDutchLabourLaw UNETHERLANDS/$FUe/Introduction%20to%20Dutch%20Labour%20Lawn.pdf.

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assessment. The extent of exposure is mapped out and the means for reducing it identified. It is argued that if these measures are taken satisfactorily, the concentration of chemical substances in air should not require monitoring since the outcome of the introduction of the appropriate means of reduction will have achieved the required effect, rendering the need for monitoring redundant. Therefore, the Labour Inspectorate undertakes or orders monitoring of exposure only in exceptional cases, if reasonable doubt exists about the situation in a company and the employer is not willing to take measures. OHS convenanten. Another relevant development in OHS regulation in the Netherlands was the announcement in early 1999 of the Secretary of State's intention to conclude socalled OHS convenanten (arboconvenanten) with a number of sectors of industry and public services. They aimed to reduce populations at risk; that is, those exposed to prioritised occupational hazards. The government initially selected 29 high-risk sectors, but additionally, other sectors applied spontaneously (probably stimulated by the subsidies the government made available for the drafting and implementation of OHS convenanten). By November 2002 there were 19 declarations of intent and 33 convenanten. By January 2004 some 50 conventanten were in force, and many of the original ones were planning a second phase. The strategy can be considered a further application of the idea of self-regulation and self-reliance.425 However government involvement, by being a party to the covenant (particularly because of its provision of financial support), perhaps makes it more appropriate to characterise the convenanten as another manifestation of the Dutch poldermodel. Still more interesting is the incorporation of some elements of the various convenanten, such as weight limits or noise thresholds, into public regulations and the thereby adoption of these standards in inspection policy. An example here is the recent incorporation of limits on heavy lifting for employees on construction sites. Hence it is argued that a mix of public/private regulation is emerging (see below). In the first phase of setting up convenanten they were signed in sectors in which there was recognised to be significant exposure to occupational hazards. In the second phase there has been a shift in State involvement. It is currently directed towards the establishment of such agreements in sectors in which there are high levels of claims for Indeed, within the increasingly neo-liberal profile of the current Dutch economic and social; policy conventanen are frequently referred to as voluntary arrangements between labour market partners with the role of the state in stimulating and supporting them minimised.

302 Beyond Limits benefits for absence under the Disablement Benefit Act - and the reduction of absenteeism and its costs are now more overtly the drive behind state engagement (Min Social Affairs and Employment 2004). Enforcement policies and practices. According to the official policy of the Dutch Labour Inspectorate, the obligation for companies and establishments to produce a risk assessment should eventually lead to a reduced role for the Labour Inspectorate in routine inspection. That is, it should be internal checks and balances in a company that come to play a key role in correcting employers' unwillingness or bad behaviour with regard to OHS matters. To achieve this change in strategy, Labour Inspectorate inspections are focused more on the management systems of the firms they visit. Inspecting (and if necessary correcting) shop floor situations is no longer an end in itself. Rather, the preferred approach means that shop floor inspections should be used as a way in to control the company's OHS management system. By seeking the reason for shop floor irregularities in deficits in the company's OHS management system, enforcement can primarily take place at a system level. An exception is made for serious offences, which will still be enforced in a direct way. Prominent in the Inspectorate's official policy is a movement away from its former advisory role, whether at a shop floor level or system level.426 The new actors in the field of OHS-regulation - the OHS services - are supposed to take over this role. With the introduction of an administrative fine as an instrument of enforcement, the Inspectorate is considered to have confined itself even further to the role of 'OHS police'. The inspectorate suggests that from 1994 onwards it has put great emphasis on the relation between occupational health problems on the shop-floor and their management, 426

Formally, this policy was introduced as a consequence of the infringement of certain articles of the WEA being defined legally as economic offences, however, in practice it revealed a new notion of government withdrawal. It was also strongly associated with the government's preoccupation with enforcing basic norms and achieving short-time results. As a result, the meaning of self-reliance changed and while the responsibility of employers and workers remained the cornerstone of the concept, the supportive attitude of the Labour Inspectorate no longer formed a contributing aspect. Instead, the policy-makers took a distant, formal and strict approach in which employers and employees were expected to regulate working conditions in order that the Inspectorate kept its distance. If they did not, then the Inspectorate would strictly enforce the prescribed norms.

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and not only by looking into the paper world of the Risk Assessment documentation. Its policy has been to define the most severe occupational health problems for each economic (sub-) sector. They are the main topics of its inspections in the sector concerned and inspectors start their inspection on the shop-floor to discover whether or not these problems are properly handled. It they are not satisfied they may give a warning or a fine and look into the risk assessment to establish whether the risk has been properly managed at the policy level of the company. Similarly, in cases of complaints or accidents, the inspector will primarily focus on the causes, give a fine in a breach of law and successively look into the risk assessment and the plan of action. However, researchers that have observed the strategy of the Inspectorate in practice does not entirely agree with this assessment and suggest that the Inspectorates' practice could more easily be described as 'business as usual', in as far as it contains few elements of system control and when it does, inspections do not usually have a bottomup character, but are executed from the top down. That is, according to these researchers, shop floor irregularities are not the entrance to system control.427

OPERATING THE DUTCH APPROACH TO OELS The policy and regulatory background described in the previous section gives us the clues we need to understand the significant features of the Dutch approach to setting and using QELs. Dutch OELs are assessed for technical-economic feasibility by the MACValue Sub-committee of the Social and Economic Council. They are legally binding and monitoring exposure levels should form part of risk assessment. This is a function undertaken or approved by the Arbodiensten, that it is mandatory for employers to call in to support risk assessment and evaluation. The extent to which this occurs in practice however is somewhat debatable. Surveys of compliance with risk assessment requirements have showed it to be incomplete.428 A similar pattern occurs in the Netherlands as is experienced in other countries. Large enterprises show a much higher degree of compliance than is experienced in small

An indication is that, in 2000, less than 3 per cent of the companies inspected were fined for not having conducted a risk assessment, whereas at that time less than 50 per cent of the companies had in fact complied to the WEA in this respect (Popma et al 2002). Recent surveys put this figure higher — at 75 per cent. Karageorgiou et al (2000: 272-274) and Popma et al: (2002:204-205).

304 Beyond Limits companies despite almost all enterprises having access to the services of the Arbodiensten. Monitoring in practice may be complicated by the fact that it would appear to be not only the Arbodiensten that are involved. Interviewees in this study, suggested varying degrees of involvement of other technical consultants independent of the Arbodiensten, such as free-lance occupational hygienists or members of university departments etc., although no precise figures were available. A corollary of this, also suggested by some participants is the notion that the Arbodiensten may not always be optimally skilled or equipped to carry out monitoring.429 Although such services are required to be multidisciplinary in order to be certified, the dominance of market determinants of their usage by employers may mean that occupational hygiene skills and instruments are less widely available in practice within the Arbodiensten than might be theoretically anticipated. It is difficult to determine whether this in fact amounts to a problem. It is also likely that there will be considerable variation between sectors, with those sectors in which there are large enterprises using chemicals for which OELs exist, being more likely to be serviced by Arbodiensten with occupational hygiene monitoring skills and experience, because of the market demand, than other sectors where there is less demand. However, since such demand is also a function of employers/employees knowledge and awareness of chemical risks to begin with, being less well served does not necessarily mean being less at risk. Under such circumstances, in the absence of detailed survey evidence, it is difficult to know how much the needs of workers exposed to risks from airborne chemicals are being addressed. It would seem probable that within the market driven Dutch system, given its overt focus on sickness absence and medical surveillance, there are likely to be many situations, especially in smaller enterprises where chemical risks exist, but where monitoring requirements remain unmet. It is also arguable that the resources needed to meet such demands anything like completely would be enormous. Moreover, as we have seen in other countries there is a further argument suggesting that such an approach would, anyway, be unnecessary for the majority of situations in which chemicals with OELs are in use. It is partly in cognisance of these kinds of issues that in the Netherlands during the past decade there has been a conscious effort to explore alternative approaches to addressing prevention of chemical risks.

According to Popma et al (2002:202) over 90 per cent of contract! concluded with OHS services consist almost exclusively of medical care, with little investment in preventive activities.

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In the strategic approach to the practicalities of controlling chemical risks, the point of departure is the requirement in Dutch law to reduce exposures to substances hazardous to health. The so called Strategy of Industrial Hygiene, guidance made under the WEA provides the guiding principles that aim to reduce exposure by using recognised good industrial hygiene principles such as appropriate engineering controls as close as possible to the source of exposure. Generally speaking, this involves for example: -

tackling the problem at source by replacing or removing the hazardous substance physically separating people from the source of danger installing ventilation, extraction systems etc. as a last resort, providing means of personal protection.

Employers are required to produce a risk inventory and to draw up an action plan indicating how they will make improvements. The determination of the extent and duration of exposure of workers to substances hazardous to health is an essential aspect of the risk inventory. Theoretically, therefore there should be quite extensive measurement of exposure undertaken by or on behalf of the employer (such as that by the Arbodiensten mentioned previously) as well as some data from monitoring by the Labour Inspectorate itself (which occurs when there is reasonable doubt about the situation in the company and the employer is unwilling or unable to undertake measurement). However, trade unions believe that only 25 to 40 per cent of companies actually undertake such risk evaluations and even fewer (15-20 percent) are really measuring levels in workplace air. These estimates are based in part on the sources of information on extent of risk assessment in general (see previous section and the reports available from the Ministry430) and in part on reports from the Labour Inspectorate concerning approaches to chemical risks in specific sectors. Given the limited number of enforcement actions taken in relation to risk assessment generally (see Popma et al 2002), it seems unlikely that there will be significant enforcement actions following the failure of companies to measure OELs as part of their obligations to document risk assessment. This is borne out by limited data in available Labour Inspectorate reports concerning inspection projects in various sectors. They identify the violations and enforcement actions, sometimes with reference to hazardous chemicals but generally do not indicate that monitoring of OELs featured significantly as an aspect of either the violations or the enforcement actions. For example, in the inspection report for the year 2000 on the metal working sector, there were a total of 962 violations of which over 300 were to do with not evaluating chemical risks in See www.vastminszw.nl.

306 Beyond Limits relation to carcinogens but only three specifically referred to exceeding exposure limits. In other violations in the sector concerning chemicals such as, for example, in handling of solvents (42 violations), there was no mention of OELs (Min. van Soc. Zaken en Werkgelegenheid 2001431). In inspection reports for 2000 in the chemical sector, practices concerning dangerous substances were amongst the most frequent violations of the law but OELs are not mentioned. Similarly in reports for the same year for sectors dealing with paints, agrochemicals, rubber and plastics there was mention of work with dangerous substances, but no mention of violations or enforcement actions in relation to exposure limits. Trade unions point to several ways in which the Labour Inspectorate operates in relation to monitoring compliance with standards on managing chemical risks (including compliance with OELs). It issues warning instruments, it follows these with enforcement actions if it believes the duty holder has not heeded the warning. It can serve spot fines, including in relation to failure to comply with requirements on OELs (as previously noted). It can stop work altogether if the inspector believes there are imminent and direct dangers to employees. However, these actions are more common in relation to faulty machinery than with regard to the use of chemical substances. The inspectorate is also obliged to investigate employee complaints. Trade unions are able to put pressure on the inspectorate to be more reactive in this respect by themselves recording and supporting employee complaints. Given that concerns about chemical safety form a large proportion of the inquiries that trade unions receive from workers (see below), this in theory should mean that there are a substantial number of inspections that deal with the management of chemical risks. In certain sectors such a metalworking and ship repairing there is more information available on the number of companies with risk evaluation reports and about the level of measurement of OELs. These are amongst the sectors in which the Labour Inspectorate has adopted strategies in which it is trying to work in a more systematic way and to inform and engage employers in its effort to make risk evaluation a more meaningful activity for them (see previous section). It has reported some success with these approaches. Officials from trade unions organising in these sectors that were interviewed in the present study suggested that such approaches were instigated following union demands and that they are undertaken in conjunction with the trade

Unpublished Labour Inspectorate reports on inspection statistics for the year 2000 were obtained for a number of industrial sectors, including chemicals, paint, agrochemicals, metal-working, plastics and the rubber industry.

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unions and employers. The systematic approach that has been adopted also results in more attention being paid to measurement of OELs as indicators of risk evaluation. Substitution, the Dutch approach. The generally unsatisfactory nature of this position coupled with concerns in relation to exposures to particular classes of substances (such as those to organic solvents for example) has led to the development of further strategies aimed at reducing chemical risks. The best known of these is the Dutch approach to substitution, which was primarily conceived as a means of addressing the problem of exposure to organic solvents, but which has subsequently been adopted more widely. The origins and development of the substitution approach can be found in concerns on the part of trade unions and sympathetic experts that the system for setting OELs and their translation into effective strategies for chemical risk management was not producing adequate results in practice. Generally, although the industrial hygiene principles of the law imply that quantitative measurement of workplace air is required where hazardous substances for which an OEL is specified are in use, as we have seen, evidence suggests that such practices are not widespread. Also employers were reluctant to commit themselves to such a practice and preferred the notion of a qualitative assessment. The Labour Inspectorate often supported employers in this preference. Furthermore the weaknesses inherent in the meaning of the exposure limits (i.e., the health/economic and technically feasible debates) often meant that even where substantial and measurable adherence to the OELs were observed, the safety of employees could not be assumed. During the 1990s, following the asbestos crisis, trade union health and safety departments became more aware of members' concerns over chemical safety. Nowadays for example FNV Bondgenoten"1 records all inquiries from workers about health and safety. Those on chemical safety are amongst the top three matters on which it receives questions. A particular focus of concern was the incidence of organo-psycho syndrome (chronic toxic encephalopathy). Exposure to organic solvents (widespread in industries producing and using paints, printing inks, varnishes, glues and adhesives, degreasers and cleansers) is common amongst decorators, paint sprayers, automotive sprayers, industrial sprayers, printers and production workers in paint factories, chemical industries, metal industries and polyester processing industries. Roughly half a million workers in the Netherlands were estimated to have daily contact with organic FNV Bongenoten is the largest trade union in the Netherlands with over one half million members. It was formed in 1998 as the result of a merger between four smaller unions, representing workers from a variety of sectors including transport, metal manufacture and chemicals, private services, and agriculture.

308 Beyond Limits solvents. Growing awareness of problems associated with exposures to organic solvents during the 1990s led to recognition that applying the principles of the industrial hygiene strategies that were the basis of the guidance to achieving compliance with the WEA previously described, would at best, only contribute to reducing the number of workers affected by organic psycho syndrome (OPS) in the long term.433 Also trade unions argued that companies and the Arbodiensten were failing to invest sufficient effort in these principles, and the Labour Inspectorate's efforts to ensure they complied were not producing adequate results. In short, they argued there was a considerable gap between the legislative principles and the workplace reality. Moreover, a further issue highlighted by concerns about OPS was the limitation of using OELs to manage the kind of chemical risks involved in causing the condition. People were identified as suffering from the condition while at the same time employers claimed that exposure limits were being observed. One reason for this was that the OELs in question were based on time-weighted average exposures. They therefore took little account of possible peak exposure. It was argued that the work methods involved in using organic solvents often resulted in peak exposures to individuals that were greatly in excess of the OEL but which were not measured.434 A long and difficult political struggle followed, in which trade unions argued that the substitution principle needed to be put more prominently in the strategies of compliance and that it needed better reinforcement by the regulatory agencies. The condition of OPS was eventually recognised as a work-related disorder, and in 1997 the government decided it was necessary to address this issue specifically by tightening the requirements of the WEA to reduce health risks from organic solvents by tackling the issue in a different way. A principle of substitution became part of the guidance adopted by the Ministry for Social Affairs. It began to come into effect in January 2000. In a number of sectors where it was considered that there was inevitable and unavoidable exposure to high-risk substances a substitution regime was set out, sector by sector. Trade union and employers' organisations were directly involved in the development of the regime. Tripartite discussion took place on the way in which this principle of substitution could In the late 1990s it was estimated that there were 2,500 workers seriously affected by OPS with about 200 new cases each year (interview with FNV Bondgenaten 2002). While the health effects of short term exposures are not understood, the Health Council has now issued an opinion suggesting that it is likely that short-term exposures contribute to OPS. As a result it has introduced a Short term Exposure limit (STEL) of twice the OEL for organic solvents and a ceiling value often times the OEL. However, this does not entirely solve the problem since there are difficulties with the instant readout instruments required to measure such exposures in many workplaces.

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be put into practice in sectors such as car repair, interior decorating, floor covering and printing.'135 Agreements were reached in these sectors to replace certain organic solvents with less toxic products. In other sectors such as metal-working, shipbuilding, furniture manufacture and cleaning, tripartite discussions are continuing. As well as the political debate surrounding the principle of substitution there is also the question of defining what can be substituted. In every case there is a debate between the trade unions, the Ministry and the employers. Manufacturers obviously have a major economic interest and are heavily involved. Generally the approach to substitution is product based. For example, it is forbidden to use indoor wall paints with greater than 75 grams of organic solvent per litre of paint. Another approach that is used in printing is to base substitution on flash-point classification and definitions of volatility, thus forbidding the use of substances with low flashpoints/high volatility. The major difficulty with these approaches is that while they work reasonably well for specified processes there are problems with their wider application and this often results in the need to formulate a specific substitution obligation for each process. This is clearly time consuming and resource intensive. In attempting to address this issue the chemical industry has tried to introduce generic standards that are based on a coding system that is a combination of physical properties of the product such as its organic solvent content and vapour pressure with the OEL for the solvents it contains. Using this approach allows simple calculation of the amount of air needed to ventilate a room in which the product is used and can thus be an means of determining both choice of materials and work methods to maximise safety when using products containing organic solvents.436 Despite the many problems encountered with the practical application of the substitution principle, Dutch trade unionists and their supporters believe that it is nevertheless an effective way of thinking about how to manage chemical risks in which many of the problems associated with OELs can be avoided. For example, it makes debate redundant about the extent to which OELs represent safe levels. It is relatively simple conceptually and does not necessitate the detailed (and often technical/scientific) understanding required to appreciate the limits of the use of OELs in managing chemical risks. Nor is it necessary to provide sophisticated skills and instruments in order to monitor risk, as is often the case with OELs. Moreover it shifts the onus of providing for safety away from users and on to suppliers. When this is supported by Interior decoration and carpet laying was the first sector to be regulated in this way. For example, a similar approach is used in Denmark where, paints have a coding classification on their labels. The higher the value the greater the risk, thus for example, a painter knows s/he can only use paints indoors that have a coding below 001.

310 Beyond Limits market-orientated regulatory strategies that provide positive incentives to manufacturers and suppliers to adapt their production to meet demand it has the potential to encourage research and development strategies aimed at safer products. While presently, most of the experience of substitution is in decisions around the use of organic solvents, the principle itself has a considerably greater range of potential applications in managing chemical risks. Of course this is very much a best-case scenario - it is highly unlikely that the principle of substitution would result in the practical substitution of safer products in anything like every situation in which a hazardous substance is used. It is nevertheless a powerful point of principle and a useful orientation towards thinking about strategic approaches to using hazardous substances. This is especially so when it is linked, not only to using substances in work situations but in an holistic way to their production and to the environmental consequences of their use.437 The significance of the approach becomes even more apparent when it is placed in the context of the broader governmental strategies outlined previously. Successive Dutch governments since the early 1990s have placed greater emphasis on the role of private self-regulation, privatised services, market based approaches and state retreatism in regulating occupational health and safety. Involving suppliers in this process is a logical extension. Coupled with the Dutch poldermodel tradition, this means that social actors in the employment relationship and the increasingly market driven advisers of employers as well as the manufacturers of hazardous substances are all encouraged to work together to achieve private solutions to risk management that are perceived as beneficial to all parties. Convenanten, a farther extension of self-regulation. As we saw previously, recent quasi-regulatory strategies of the state have attempted to build further on these approaches through the development of convenanten at sectoral level. The role of convenanten in regulating chemical risks is therefore quite important. Although the coverage of sectoral convenanten is normally broader than chemical risks alone, such risks and OELs may form part of the convenanten that are agreed or under discussion in some sectors. For example in construction the covenant includes recognition that new tools are needed in order to avoid exceeding the MAC level for airborne quartz. Part of the agreement therefore included support for the design and introduction of grinding tools (and modification of existing ones) to improve their dust extraction systems. A performance certificate has also been developed to enhance the opportunities for This is what has happened in the graphical industry where the Ministry for Social Affairs has adopted an environmental agreement that has achieved a ban on ammonia chlorinated hydrocarbons (including toluene) in the industry.

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companies to buy tools that meet the required standards for dust emissions (Min Social Affairs and Employment, 2004:14). hi the furniture industry a covenant has been agreed in which the aim is to support the switch from using products containing volatile organic solvents (VOCs) to those that either do not contain solvents or have only low solvent levels. A VOC scan is being undertaken in 400 companies to determine the extent of use and to investigate the technically and economically feasibility of substitution and of other methods of control for such substances (Min Social Affairs and Employment, 2004:112). Trade unions have engaged willingly in the negotiations that lead to convenanten in some sectors. They perceive advantages in being involved in the development of the prevention strategies they contain. At the same time they are wary about the notion of responsibility that is implied by the convenanten and in particular, the way in which the existence of the covenant is perceived to allow withdrawal of the Labour Inspectorate from engagement hi active enforcement in the sector. The development of the use of convenanten is quite well illustrated by the experience of dealing with the problem of wood dust. In 1994 the trade unions and employers' organisations in the parts of the wood industry (wood trades, furniture industry and timber) agreed there was a need to revise the OEL, because of its hazards generally and in view of the debate on the carcinogenic properties of some wood dusts. Up to this time the Arbodiensten used in the industry were themselves not always aware of the significance of the risks associated with wood dust and frequently did not measure exposure levels when carrying out risk assessment on behalf of employers, hi 1996 the trade unions and employers agreed to a voluntary lowering of the OEL from 5mg/m3 to 2 mg/m3 in the timber and furniture industry. This was incorporated in legal requirements inl999. As the industry is composed mainly of small enterprises in which there are real problems of health and safety awareness, during these three years, employers and trade unions in the sector collaborated on many activities to publicise the new level and to advise companies on how it could be achieved. The unions also mounted their own campaign that was well received in the industry. The social partners both together and independently, extended information provision, including that to the personnel of the Arbodiensten. Despite the resulting raised awareness, not surprisingly, employers had concerns about the increased cost of measurement to monitor compliance with the new OEL. Partly for these reasons, the trade unions and the industry launched a project with the aid of a professional occupational hygienist, to develop a measurement protocol on simplified means to assess wood dust levels in workplaces that would be uncomplicated and inexpensive and which included

312 Beyond Limits subjective estimates of the levels of contamination.438 The measurement protocol was agreed by the Labour Inspectorate and the Arhodiensten also informed. In each Labour Inspectorate region of the Netherlands, there is an inspector with overall responsibility for seeking compliance in the wood industry. There is therefore a small group of inspectors who have become highly specialised in the means to evaluate and control risks in the sector. Trade union health and safety officials believe that there has been considerably more measuring of exposure levels in the industry as a result of all these activities and they perceive Labour Inspectorate demands for measurement to be more insistent as a result. For example, during the past two years the Labour Inspectorate has made a special effort to inspect woodworking companies. If companies are unable to present inspectors with a measurement report showing the extent of compliance with the OEL, in the majority of cases the Labour Inspectorate has demanded measurements be taken and reported. Indeed, the employers* organisation in the timber industry has complained that too many measurements have been demanded of its members by the inspectorate. At the same time as these developments based on social partnership in the sector were taking place in the late 1990s, the Dutch government was promoting the notion of sector based convenanten in which employers and trade unions would take on greater responsibilities for self- regulation of the risks. The experience of the trade union FNV BOUW that organises building workers and wood workers is fairly typical. Three of the five sectors that are covered by FNV BOUW were amongst the 29 high-risk sectors selected by the government as areas in which convenanten might be developed. The trade union was initially approached by the state to explore whether it would be interested in developing voluntary tripartite arrangements in relation to certain hazards in the sectors in which it was active. There were considerable resource incentives provided by government to facilitate these developments. Trade unions and employers organisations in the various sectors met to create intention documents which, following a period of further discussion between the tripartite partners are elaborated into convenanten. One of the key aspects of the convenanten is the requirement that they must have measurable objectives, to ensure that they did not simply become another paper exercise that was ignored in workplace practice. Therefore, baselines are established in the convenanten. Progress can be measured in terms of objective indicators of achievement in comparison with these baselines over '.. .if you can't see the other side of the room — you know you have a problem. If you can eat off the floor you know you don't. It is the grey area between these two where you need to measure'.

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time. In theory OELs provide such useful objective indicators. Where they are used in convenanten it is normally with the proviso that the partners to the agreement will strive to reach levels of performance that improve on that set by the OEL. However, there is a pragmatism evident in the choice of what is achievable and it is interesting to observe that there is variation in the risks that the partners have agreed to include in the covenant. For example in the timber industry the areas under discussion include physical strain, wood dust, noise and psychological strain. The same ones and additionally, return to work strategies, are included in the wood trade. However, in the furniture industry the subjects include organic solvents, physical strain and return to work strategies but wood dust has been excluded. Clearly the differences in subject matter reflect awareness about the risks encountered in different sectors. But they also reflect a sense of what is achievable. Thus, while wood dust is a major problem in the furniture industry it is not amongst the issues that are agreed to be part of the covenant. Because it perceived it to be a significant problem the trade union wished it included. However, the employers' organisations refused because, while it did not dispute the nature of the risk, it was not confident that the industry could meet the improved exposure limits that would have been required in the covenant. Eventually the union reluctantly agreed. The spokesperson for the union interviewed in the study argued that while they are still unhappy about the exclusion of a significant risk from the covenant it is easy to see, in hindsight, the problems that would have been caused by including unrealistic standards. She pointed to the struggle currently experienced in sectors with less of a wood dust problem, such as the timber and wood trades, to even reach the minimum standard of 2mg/m3, let alone go beyond it as is required in the convenanten they have agreed. The covenant is not intended as a static instrument. It is therefore quite feasible that inclusion of improved targets for reducing wood dust exposures will take place in the future as social dialogue on the issue continues, market pressure is brought to bear on manufacturers to improve machinery emissions/extraction and the industry becomes more confident of their achievement as a result. An approach that is not only self-regulatory but also a systematic strategy for OHS management is an important feature of the tripartite dialogue behind the covenant It is also fundamental to the state policy that informed their introduction. It relates to the systematic approach in the legislative strategy of the WEA 1994 and 1998 and the resulting inspection and control strategy of the Labour Inspectorate mentioned previously. In this respect OELs are not the central issue for preventive strategies. They may on occasion be useful indicators with which to help measure performance against the agreed targets for systematic OHS management, but in many cases there may be

314 Beyond Limits other equally helpful indicators. In addition, application of the substitution principle (an important principle that the trade unions have sought to retain in the negotiation of convenanten) can often mean that measurement of OELs for hazardous substances will become increasingly unnecessary as the hazardous substances themselves are replaced. The self-regulatory element of the convenanten is one that has caused the most disquiet amongst critics who argue that they imply a reduced role for the labour inspectorate and are in keeping with strategies of withdrawal of the state from regulatory activity. The negative effects of this at the level of the workplace, is a cause for concern about reduced protection for vulnerable workers. The idea of shared responsibility for health and safety between workers' organisations and the employer implies that there should be a shared distribution of power within enterprises, which is far from always (if ever) the case. In practice this means in effect that where there is a well-developed worker organisation for health and safety within a workplace the covenant may have a positive role in further enhancing and supporting its engagement in OHS issues. This seems to be taking place in sectors such as metal manufacturing, chemicals, construction and woodworking, where trade union officials report progress with access to information and positive discussions with employers on OHS strategies including those relating to managing chemical risks, hi these sectors trade unions also report positively about the opportunities convenanten provide for the workers' organisations to be more proactive on work environment issues and to be directly involved in building up knowledge on solutions to problems. They also suggest it presents a new way of working more positively within the trade unions themselves. However, while it may enhance workers' rights to such things as information and participation in managing chemical risks the covenant itself cannot create workers' organisation. Therefore in sectors where such organisation is weak, it is feared that the existence of convenanten may be counterproductive. Not only will unorganised workers be unable to take advantage of the potential for increased participation that convenanten offer, they may even become more vulnerable because Labour Inspectorate inspection strategies result in less inspection in such sectors. It is also pointed out that unlike labour inspectors, workers and trade union representatives have no legal instruments to ensure compliance. The withdrawal of the inspectorate as a result of the covenant therefore implies an increased responsibility without an increased authority for workers' representation, hi such sectors it is therefore difficult to see how conventanten will represent a useful way forward for compliance strategies on chemical risks.

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CONCLUSIONS In this chapter we have drawn attention to the long and continuing history of corporatist approaches to regulating occupational health and safety in the Netherlands. The well developed structures for setting OELs that address both health and economically based issues reflect this history. The sectorally based social dialogue resulting in emphasis on the principle of substitution as well as the development of agreed performance targets and their indicators in sectorally specific convenanten is a further manifestation of the corporatist approach. At the same time, aspects of these developments also reflect the large degree of pragmatism evident in the Dutch approach evident at both central and sectoral level. Recent regulatory approaches to occupational health and safety in general have increased the emphasis on self-regulation and self-reliance at sectoral and enterprise level. Partly as a consequence of this, the involvement of the social partners in setting work environment strategies that aim to deliver defined performance objectives is evident especially at sectoral level. At the same time national regulatory strategy has emphasised a systematic approach to OHS management. However, systematic approaches to inspecting OHS management may be less well developed in practice than might be assumed from regulatory policy and some scepticism has been expressed concerning this issue. These developments have a number of consequences for the role of OELs in inspection and control. For example, OELs sometimes feature in the definition of performance based targets in the self-regulatory strategies agreed at sector level. They can also be performance indicators at the workplace level for systematic OHS management However, they are not the central feature of either and as such they are not perceived as ends in themselves but mainly as tools with a role in measuring the extent to which the more fundamental self-regulatory and systematic strategies to achieve OHS management in relation to chemical risks are working. How has this all affected the daily business of managing risks associated with the chemical substances? Theoretically, those with OELs require evidence that exposure levels are acceptable. This is normally obtained on behalf of employers by the occupational health services (Arbodiensten) with which (until July 2005) they are obliged to contract to ensure that the risks of their enterprises are evaluated appropriately. However, the degree to which this is actually carried out appears to be less man optimal. Although risk evaluation is a statutory requirement for the services

316 Beyond Limits that the Arbodiensten supply to support employers, they are commercial organisations and the main market demand for their engagement is directed towards sickness absence and medical surveillance. Therefore it is likely that unless employers demand it, they will not undertake such monitoring. For the same reasons it is also likely that despite requirements on competence many of the Arbodiensten may not posses the expertise required for sophisticated monitoring of OELs. Moreover the extent of enforcement of the demand for this level of monitoring is also in general, limited. This is one of the reasons why trade unions have adopted a strong line on substitution strategies which, if undertaken successfully render the need for this kind of monitoring largely redundant. There is no doubt that OELs have played an important part in the development of awareness concerning chemical risks in Dutch workplaces. In this respect their role is regarded as important. At the same time, the limitations of over-reliance on exposure standards is also perceived. As a result a recent, strong emphasis on the principle of substitution as a strategic choice for managing chemical risks has emerged as a major strategy in controlling chemical exposures at the workplace. Emphasis on the substitution of organic solvent has been a prominent feature of national and sectoral approaches to substitution. These developments are evident in relation to the two reference substances in our study - toluene and wood dust. The primary strategic approaches to dealing with risk management in the case of toluene often involve discussion of the issue of substitution. Inspection strategies in cases in which there is no obvious substitute for toluene (such as for example in gravure printing processes) appear to require evidence of OEL monitoring. And indeed, in the case of gravure printing, there is fairly extensive monitoring of toluene by occupational health services, although employers tend to interpret the OEL literally as a safe level.439 Although the existence of the OEL can stimulate the awareness of chemical risk in relation to a specific substance such as toluene to spread quickly in an industry, generally, once it is established that that exposure does not exceed the OEL, further measurement is seen as unnecessary. The value of the OEL both in substitution and in control at source appears to be linked to awareness of chemical risks. At the sectoral level therefore, where OELs exist they are a factor influencing the development and acceptance of strategies to deal with chemical risks. In the case of employers and suppliers, subsequent outcomes at the level of the workplace are dependant on the extent to which their organisations at sectoral Since monitoring is often of time weighted average exposures, peak exposures and therefore possible risks of OPS may be missed.

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level, in turn, have influence over individual members.*™ In other cases, where an OBL is incorporated as part of a system for managing chemical risks at workplace level it doesn't much matter about awareness of the OEL, the fact that it is part of the risk management system means that efforts will be made to achieve compliance with it. Thus if a system exists, then the OEL is important. Conversely, if there is no OEL for a substance, then there is no data and therefore no system for its risk management. Wood dust has been the focus of attention because of relatively recent renewed interest in risks of exposure - especially because of potential cancer risks. As with organic solvents, debates around the question of the most appropriate level to set the OEL have been important in raising awareness at sector level, but probably less significant in this respect at the level of the enterprise (which in the wood industry are mainly small enterprises). As a result, it was the subject of a number of campaigns and projects run jointly by trade unions employers in the industry and the Labour Inspectorate, as well as by these organisations separately during recent years. As a consequence of this attention, compliance with the OEL is quite extensively monitored by the Labour Inspectorate and a group of its inspectors have become particularly knowledgeable and experienced in the problems of achieving compliance in the sector. They have tended to work closely with trade unions, employers and suppliers of machinery at sectoral level and monitoring exposure levels has become a prominent part of strategies to reduce them at workplace level. At the same time, controlling wood dust exposure is one of the targets set in tripartite convenanten in some (but not all) sectors of the industry. This is quite a good illustration of the pragmatic approach that is evident in Dutch strategies. Controlling wood-dust levels in workroom air to acceptable measurable standards (such as to levels below the proposed new OEL) is regarded as extremely challenging by employers in the furniture industry, for example. Therefore, despite the fact that exposure to wood dust is a serious problem and employers organisation would like to reduce exposures in the long term in the many small enterprises that constitute this sector, it is not included in the current convenant applying to the sector. Instead, it is part of convenanten in other parts of the industry where achieving such controls is regarded as more realistic. The trade unions and the inspectorate are not entirely happy with this situation. They

Even where there are responsible care programmemes initiated by suppliers, because distributors intervene to break the direct link between suppliers and users, there may be little awareness of risks at the level of the user.

318 Beyond Limits nevertheless recognise the difficulties presented by the employers as genuine and are nartxr in the t\ip 9on>pmpnt party to agreement More generally, the extent to which workplace structures and practices match the social dialogue at sector level on both substitution and agreed convenanten and are in practice able to achieve the performance objectives set sectorally is not entirely clear. However, this does not necessarily imply underperformance - the approaches at sectoral level are themselves new and in many cases themselves not yet finalised therefore it may be too early to see clear operational results.

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SWEDEN

INTRODUCTION The Swedish system for regulating the work environment is traditionally perceived as amongst the most conceptually advanced and well resourced in Europe and a prime example of the Scandinavian approach to the subject. It has a relatively long history of setting and using OELs and from the 1960s until the present time has set exposure limits and used them in the determination of acceptable standards of occupational health and safety (OHS) management practice in workplaces. Moreover, the levels at which these OELs have been set are amongst the lowest internationally and within the Swedish system for setting them there is a long established separation of decision-making structures on scientific issues from those that include economic and other concerns. For these reasons it seemed appropriate to examine its operation, to consider how OELs are used and how they relate to the wider system for regulating the work environment in Sweden. Generally, the features of the Scandinavian approach to work environment regulation include an emphasis on consensus and on corporatist decision-making at national and sectoral level, support from a comparatively highly developed provision of external prevention services and strong representative participation in activating health and safety at the local level. From the early 1990s in Sweden such approaches at the level of the workplace were embraced by the term 'internal control" in which a systematic approach to participative OHS management was envisaged in clarifying responsibilities and obligations of employers as responsible and accountable subjects. More recently this approach has been slightly modified and renamed 'systematic work environment management' but remains as the name suggests a systematic approach to participative OHS management.

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While some Swedish observers suggest that Sweden is not immune from the impact of neo-liberalism and as a result post-2nd World War corporatist tradition is less in evidence in current practice than in the past, OELs are nevertheless established within a corporatist national and sectoral environment and function in workplaces where ideally there are well established participative structures and procedures in place which, with the support of external prevention services, contribute towards employers* delivery of the systematic management of the risks of hazardous substances. Of course, the Swedish health and safety system and the role of OELs within it does not exist independently from the wider political and economic setting in which it is located. This wider system is far from static and as is the case in most developed market economies, it has undergone considerable change in the recent past. Such change has taken place not only in the structure and organisation of work but also in policy concerning workability, the economics of work-related well-being and the comparative role of the state and the market in its regulation and governance. These changes have had an impact at many levels and one of the aims of the present chapter considers some of their implications for the role of OELs as instruments in supporting the systematic management of the work environment. To achieve these ends the chapter begins with a brief outline of the economic and legislative background to the Swedish approach to regulating chemical risks and policy and practice in relation to achieving compliance with systematic health and safety management requirements. This is followed by some observations concerning the setting and role of OELs in the process of regulating health and safety management. Beginning with an outline of the theoretical position concerning the use of OELs, we consider the extent to which OELs and monitoring compliance with them actually form part of systematic health and safety management of chemical risks in practice. In so doing we discuss the main issues for the role of OELs in achieving compliance with measures to regulate the management of chemical risks.

THE USE OF CHEMICAL SUBSTANCES AT WORK IN SWEDEN The Swedish chemical industry plays a relatively small part in chemical production of the European Union as a whole. Nevertheless the use of hazardous chemical substances is as widespread in Sweden as in all the other countries in the study. Eighty per cent of the Swedish respondents to the European Foundation survey considered themselves very well or fairly well informed about risks resulting from the use of materials,

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instruments or products at work, compared with 76 per cent for the EU 15 countries as a whole. A slightly greater percentage of Swedish respondents felt they were exposed to breathing in vapours fumes dust or dangerous substances for at least a quarter of their working time (24 per cent) than the average for the EU 15 countries as a whole (22 per cent) but slightly fewer reported handing dangerous products for more than a quarter of their time at work (13 per cent compared with 16 per cent for the EU 15 average).

ECONOMIC AND LEGISLATIVE BACKGROUND*" Swedish regulation of OHS management follows a Nordic approach that has largely paralleled regulatory developments in the EU, but which was initiated prior to Swedish membership of the Community. The term characterising this approach during the 1990s was 'internal control' . In July 2001 it was slightly revised and renamed 'systematic work environment management' (AFS, 2001). As in other countries, the evolution and implementation of regulating OHS management is embedded in national politics, the economy, labour market and industrial relations (Frick 2002). A strong Social Democrat tradition dominated Swedish governments from 1932 to 1976, Welfare policies and their implementation have been much influenced by interest organisations, especially the trade unions (which have an unusually high membership rate of over 80 per cent). There is therefore a long history of participation of organised labour in economic and social policies. Such corporatism was underpinned by the agreement reached in 1938 at Saltsj8baden, between the main trade union confederation (LO) and the employers' organisation (SAF) (Johansson 1989, Sund 1994). However, since the 1970s both politics and the economy have become more volatile. Although modern Swedish politics has been dominated by Social Democrat governments, between 1976-82 and again between 1991-94 coalitions of centre-right parties held office. During recent decades the mode of governance has shifted towards decentralisation and market solutions with movement away from Keynesianism (Ryner 1993). Much of the formal corporatitist structure was dismantled when the main employers' organisation (SAF) withdrew from most of the boards of government authorities in 1993. Yet, like the rest of the so-called 'Swedish Model', labour market corporatism has not disappeared entirely. Unions and employers still control some

For a more detailed description of the main points contained in this summary see Frick (2002).

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formal structures and an extensive bipartite co-operation on several issues still exists, especially on OHS. Many working conditions are still regulated in collective agreements, which in other countries are, by law, individual rights (Bruun 1994).

THE SWEDISH APPROACH TO REGULATING THE WORK ENVIRONMENT The legislation. The Work Environment Act of 1977 initiated modern approaches to OHS legislation. It covered practically all employees, made employers responsible for their health and safety at work and emphasised preventive local OHS activity in which workers were to participate, through dialogue with their supervisors and through their union appointed safety representatives (see Hyden 1992 and Vogel 1998). It also broadened the definition of OHS to include organisational aspects and it confirmed the gradual shift in preventive principles from behaviour control to technical prevention. OHS requirements were further specified by mandatory ordinances including standards on new hazards and stricter requirements on old ones. The National Board and the regional Labour Inspectorate received greater resourcing and the number of inspectors grew from 175 in 1967, to around 450 in the mid 1980s who visited nearly 60,000 workplaces per year (AV 1989). Internal control. Concerns about the efficacy of the system led to further changes in the Work Environment Act with the introduction of "internal control* in an ordinance (AFS, 1992) originating from 1991. Internal control (IC) duties of employers included, among other things, requirements to: -

-

integrate a systematic approach to the work environment as a natural part of dayto-day activities give the employees, safety delegates and pupil safety delegates the possibility of participating in such a systematic approach (though the forms and rights of employee participation are specified in older regulations) establish objectives for the IC continuously assess the risks of the operations and abate them list necessary OHS improvements, which can not be abated directly, in yearly action-plans allocate tasks, responsibilities and resources to prevent ill health at work ensure that managers and workers have the necessary OHS competence audit the effectiveness of the IC and make necessary revisions annually.

Sweden 323 Though the EU Framework Directive was hardly mentioned in the reform process, by introducing internal control, Swedish OHS regulation complied with nearly all of the Directive's articles and exceeded them with its requirement of an annual audit of the adequacy of the IC. In 2001 further reforms were introduced developing internal control into systematic work environment management in keeping with EU requirements and aimed at making such management an integral part of everyday work. Assessment by the Labour Inspectorate provides an indication of how far systematic work environment management (SWEM) has been implemented. According to a report from the Work Environment Authority published in 2003,442 about 40 per cent of employers claimed that SWEM had been introduced in their workplaces and was functioning well. Some 65 per cent said they had investigated the work environment and made a risk assessment while 70 per cent said they had a good or very good knowledge of SWEM.443 hi 2002 labour inspectorate estimates of compliance with systematic health and safety management requirements indicated it believed 50 per cent of firms were in fact meeting their statutory obligations in this respect (WEA 2002). However, other studies, which have compared the Labour Inspectorates' assessments with 'expert' evaluations, indicate that the inspectors may be too lenient in their own assessment of the extent of compliance. In an analysis in 2000 for example, it was suggested that according to more stringent criteria of what constitutes a fully functioning OHS management system, only 2 per cent of the assessed workplaces actually had one in place (Frick 2002:228). Arguably, the 'true' compliance rate is likely to be between these figures, but still indicates that ten years after the mandating of internal control at least half of Swedish workplaces (and probably many more) do not comply fully, despite its role as a strategic instrument in the Swedish OHS system. Recent structural reforms of the regulatory authority. In 2001 the National Board for Occupational Health and Safety and the regionally structured Labour Inspectorate merged to form a central Work Environment Authority. Since then, efforts have been made to standardise its approaches within ten regions in which some 500 staff cover the 5.3 million people engaged in work and related activities that are embraced in the Work Environment Act in the whole country.

http://www.eurofound.eu.int/working/2004/03/SE0403NU03.htni. Of course, this measure does not account for whether employers actually knew the extent of what was required from them by the statutory provisions.

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In addition there are around 300 staff based at the Authority's head offices. As well as inspection activity the Work Environment Authority supplements and articulates the stipulations of the Work Environment Act and deals with transposition of EU legislation. To these ends it issues amendments and new working environment rules. The reorganisation of the Work Environment Authority was accompanied by an increase in the budget for the Labour Inspectorate and plans to return the number of its inspectors to that of the previous decade. The authority will also continue its strategic reorganisation towards a greater focus on organisational factors as much as technical ones, including systematic occupational health and safety management.

SETTING O E L S Procedures for setting OELs. OELs are derived from scientific data but are considered administrative limits since social, technical as well as economic aspects are all taken into account in setting them. Sweden had one of the first independent national systems for setting exposure limits in Western Europe. Its first list was published in 1969 and although it was based almost entirely on the ACGIH list of TLVs, subsequent Swedish lists have contained values that are substantially different from those of the American list. Indeed as Hanson (1998) shows the overall change in Swedish OELs since their inception in 1979 has been a steady trend towards lower values.444 The current system for setting OELs has its origins in procedures introduced in 1978 in which the then National Board for Occupational Health and Safety established two separate groups. The first of these was the Criteria Group based at the National Institute for Working Life (Kriteriegruppen fBr hygieniska grdnsvUrden Arbetslrvsinstitutet),"*5 composed of scientists whose task is to gather and evaluate the available scientific and medical information concerning substances that have been selected for its attention. A second group, known as the Regulations Group presents substances for its attention.

Hanson demonstrates that for example the change for substances overall between 1969 and 1994 corresponds to an average yearly reduction of 3.9 per cent. Most of this reduction took place in the first ten years. For carcinogens the reduction was considerably greater at 10 per cent and for solvents there was a 5 per cent reduction over the same period. This is despite the fact that Swedish OELs are not intended to be solely health based values but are set after taking into account issues of technical and economic feasibility. Originally based at the NIWL, most of the Group have subsequently moved to the IMM and the role of NIWL seems to have reduced.

Sweden 325 This group has a tripartite composition, with representatives chosen by trade unions and employers' organisations as well as members from the National Board (now part of the Work Environment Authority). Proposals for substances to be considered for OELs or for revision of existing OELs may come from the employees and employers represented by the members of the Group. Or they may be made by others such as occupational health professionals, the labour inspectorate or the secretariat for the Regulations group which is part of the WEA's Chemicals Unit. The Regulations Group drafts a priority list of such proposals for that is presentation to the Criteria Group The task of the Criteria Group is to provide the authority with the scientific criteria on the known toxicological and medical effects of the substance concerned. Published international research on the health effects of the substance in question in humans and animals is reviewed and its quality evaluated. Reviews also take account of similar critical evaluations undertaken by the Nordic Group of Experts on limit Value Documentation which is an international body set up by the Nordic Council446 to produce criteria documents for use in Nordic countries and the Dutch Expert Group which adopts a similar approach. The resulting criteria document44' from the Group contains the scientific data about the substance and if possible targets a critical effect and a dose-response/dose-effect relationship.448 The Criteria Group does not propose an OEL, rather, the criteria document provides the scientific basis for the evaluation undertaken by the Regulations Group in which issues of economic and technical feasibility are taken into account. Compliance with a proposed exposure limit is an important consideration and therefore the costs of compliance are a factor addressed in the proposal developed by the Regulations Group. A consequence evaluation is produced for each proposed limit value in which improvements in health are weighed against the costs of implementation. Technical as well as economic feasibility is taken into account and are summarised and reported to the Group to aid decision making. Data are collected from published reports, the labour inspectorate and prevention services as well as evidence from employers and trade unions in the industries potentially affected by a new or changed limit value, on the use of the substance, the volumes handled and the number of persons exposed. This The Nordic Countil was established in 1952 to promote co-operation among the parliaments and governments of Denmark, Iceland, Norway, Sweden and in 1955, Finland. These reports are published in the Arbete och ffiilsa series. The critical effect is the adverse effect that appears at the lowest exposure level (Nordberg et al 1988).

326 Beyond Limits evidence is an important part of the consequence evaluation produced by the Group (AIHA/CMA 1996). The deliberations of the Regulations Group result in recommended exposure limits which become the subject of formal consultation with trade unions, employers organisations and other bodies. The results of such consultation are taken into account by the Chemicals Unit of the Central Supervision Department of the Work Environment Authority and inform the final decision concerning the proposed limit value taken by the directorate of the National Board/Work Environment Authority. This results in a revised Ordinance on Limit Values, What Swedish limit values represent. The Swedish Work Environment Authority (Arbetsmiljoverket) is empowered under the Work Environment Ordinance (Arbetsmiljoforordmngen; SFS 1977: 1166) and Work Environment Act (Arbetsmiljolagen; SFS 1977: 1160) to issue instructions on the work environment without recourse to the legislature. The Ordinance on Limit Values (Hygieniska gransva'rden och dtgiirder mot luftfororeningar, Arbetarskyddsstyrelsens jorfattningssamling; AFS 2000: 3) is one such instruction that is revised approximately once every three years. All limit values in the Ordinance of Limit Values are binding. Some substances for example, styrene, crystalline silica, asbestos, cadmium and lead are more strictly regulated than others and subject to separate provisions since there is a demand for mandatory exposure measurement. An OEL gives the maximum acceptable average concentration of an air contaminant in respiratory air at workplaces. Concentration limits are usually averaged over eight hours ('maximal limit value', or nivagransvarde) and 15 minutes ('short-term limit', korttidsvdrde). There are ceiling values (takgransvarde) that are momentary limit values with reference times as short as five minutes. In the OEL lists, 'K' {Cancerframkallande, Grupp C), annotates carcinogenic substances, 'S' (Sensibiliserande, Grupp D), annotates sensitisers and 'R' (Reproduktionsstorande, Grupp E), indicates substances toxic to reproduction and ). H' ('Huden') annotates substances with the capability of skin penetration. The allergic potential is also considered when setting the limit value. In addition, the 'Hygienic limit values and measures for air pollutants' includes lists of substances, which are banned (Grupp A) or subject to license (Grupp B). Isocyanates, which are included on the OEL list, are also

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regulated by specific instructions on thermosetting plastics (HUrdplaster; AFS 1996:4).449 However, Swedish OELs are not intended to represent sharp dividing lines between healthy and unhealthy exposures. The recommendations that accompany the OEL ordinance state: 'It cannot be excluded that a few persons within a large group who are exposed to concentrations around or below the limit values can suffer mild and transitory discomfort. Nor can it be excluded that a still smaller number of persons in such a group may show symptoms of illness.' They go on to state that it is therefore important to seek to keep exposure to the lowest levels possible and that the OEL is not regarded as an end in itself but rather as an indication of what is definitely unacceptable. Therefore the employer is required to keep exposures to as far below the exposure limit as possible. According to this provision, theoretically, the Labour Inspectorate can enforce measures against an employer even if the limit is not exceeded.

ACHIEVING COMPLIANCE WITH O E L S The Work Environment Inspectorate450 within the WEA is responsible for enforcement of the exposure limits. It is an integrated part of the Authority and has access to all the scientific and technical support that can be provided through the WEA. The background outlined in the previous sections, provides an indication of the overall approach to regulating the achievement of better health and safety management and a clue to the likely role of OELs in this process. It shows that currently the emphasis in compliance strategies is with the achievement of systematic approaches to risk management by duty holders. Within this broad aim, there is a particular focus on certain issues for which improved outcomes are identified. Although not a priority issue

See European Agency website for an outline of this information on Swedish OEL: htrp://europe.osha.eu.int/good_practice/risks/ds/oe. The Work EnYironment Authority is currently refers to its inspectorate as 'inspection offices in ten localities*.

328 Beyond Limits in its own right, safety in working with chemicals is reflected in some of the current priority issues for the Work Environment Authority, For example, the industries that are the focus of the current Plan of Activity 2004-06 include construction and the timber industry. Hazardous substances are common in both. In the case of the timber industry the plan identifies wood-dust as a focus for inspection as well as surveillance of compliance with Work Environment Authority standards by suppliers. Since systematic management of the work environment is also a focus for attention across all the priority sectors and using OELs in risk assessment is a clear feature of Swedish regulatory requirements and one in which the labour inspectorate engagement is specifically identified, it might be anticipated that some consideration of OELs, especially in construction and the timber industry might feature in the inspection activities during the period covered by the current Plan of Activities. However, the Plan does not make any specific reference to such an intention (WEA 2004). In addition to this, as mentioned in the previous section, annual exposure measurements for certain hazardous substances including lead, cadmium, quartz, styrene, ethylene oxide, propylene oxide and synthetic inorganic crystalline fibres are stipulated by law and such measurements must be reported to the Work Environment Inspectorate. The regulatory requirements. Employers* duties of assessing risks and organising safe handling operations involving hazardous chemicals are specified in the Ordinances on Chemical Hazards in the Working Environment and on Occupational Exposure Limit Values and Measures against Air Contaminants 2000. Under these provisions, when assessing the chemical risks of the work environment, the hazardous chemical substances that occur or can be expected to occur in operations must be identified and assessment made of the risk of these substances causing ill-health or accidents. Documentation of risk assessment involving hazardous chemicals would normally be expected to contain the identity of the hazardous chemicals, note of their inherently dangerous properties and the exposure to which employees can be subjected as well as the handling risks entailed and the risk reduction measures decided upon. Guidance451 states: 'If there is a reason to suspect that the activity gives rise to air contaminants, the extent of the exposure must be investigated and account taken of its nature, level and duration. Thus, if a general risk assessment shows that air contamination may occur, these conditions need to be investigated more closely. Basic sampling See Chemicals Control at the Workplace - Limiting Chemical Hazards at Work, Work Environment Authority, Stockholm 2002 (in English).

Sweden 329 methods, for example by using detector tubes, may be acceptable means to confirm that the exposure is low. However, if the investigation shows cause to suspect that an occupational exposure limit is being exceeded, an exposure measurement must be carried out. This requires the person planning and carrying out the measurement to have the requisite knowledge to do so. It includes knowledge, concerning the choice of method and equipment, the timing and ability to identify the persons on whom the measurements should be carried out. The results of the measurements must be documented in a measurement report containing certain pre-specified data. Employees concerned must be informed of the results of the measurement and have access to the documentation.' (our italics) Regulation in practice. Compliance with these requirements however, is another matter. No specific data on compliance with limit values, of sufficient detail is available to evaluate the extent to which OELs actually feature in inspection practice. There are some statistics on actions by the Inspectorate in the occupational hygiene field that have been collected during the last five years. However these are not particularly helpful in determining how OELs are used in inspectorate interventions.452 The following observations are therefore based on what can be inferred from information on the inspection of health and safety management more generally combined with the views of inspectors and officials of the WEA and those of trade union representatives that we obtained in interviews that were undertaken as part of the fieldwork for this project. It is clear from the evaluations of the systematic health and safety management referred to previously, that this practice is far from universal. It is not possible to tell from these evaluations the extent to which employers carry out exposure measurements when assessing risks as part of systematic health and safety management, as they are required to do when exposures to chemicals with OELs are suspected. However it would seem unlikely that they would depart significantly from the generally limited compliance with systematic health and safety management that seems to be the norm. Moreover, according to officials of the Work Environment Authority, it is a problem to get many In addition there are occasional pieces of information relating to specific campaigns, such as during Health and Safety Week in 2003 when hazardous substances was the focus, the SWEA inspected 1800 workplaces in70 per cent of which it found cause to issue notifications concerning problems relating to chemicals and safety data sheets. Http://www.prevent.se/english/newslatter/ twooutafthreearenegligentwithhaza. asp. The same source reports a survey by the construction workers' union Byggettan in 2001 in which only one third of the 1,376 building workplaces surveyed had any form of risk assessment of hazardous substances been undertaken.

330 Beyond Limits employers to realise that OELs even exist. They suggest that employers are in fact measuring less than they have in the past. They attribute this decline, which they regard as quite marked over the last decade, at least in part to prohibitive costs of prevention services carrying out such measurement453 This observation was strongly endorsed by trade union sources, who argued that not only did prevention services not monitor any more because employers did not request them to, but that such services did not promote monitoring and did little to raise employers' awareness of its role.454 Trade union and other sources also claimed that preventive services have been employing fewer safety engineers and occupational hygienists. This was regarded as being brought about by the current orientation of prevention services towards responding to the occupational health needs perceived by the employers who were the market for their services. It was further argued that in articulating such needs both employers and often their workers too, were more interested in the role of occupational health services in relation to individual health concerns than they were in what was sometimes perceived as potential 'interference' by OHS in the (lack of) collective prevention strategies adopted by firms. It was further pointed out that it required an active union policy to deny members this perceived personal support in favour of prevention measures that were of a more collective nature, and as a consequence unions had become less involved than they were in previous times in deciding on which services were to be hired. Since employers themselves showed low awareness of the role of OELs in monitoring for compliance with health and safety standards for hazardous chemicals, it followed that there was limited market driven demand for occupational hygiene services. As the demand for these services has become less, there were increasingly fewer people employed by prevention services who could actually undertake monitoring properly. The trade unions also claimed that there has been a reduction in the provision of professional education and training to enable specialists to undertake monitoring. Such a cycle would inevitably contribute to fewer measurements As pointed out previously, prior to 1992 such services were heavily subsidised by the state (at around 30 per cent of their cost). Removal of subsidies coupled with the withdrawal of the employers' organisation from the national OHS service agreements from 1993 resulted in increased commercialism of the services influenced the extent to which they are used by smaller enterprises especially. Decline in the number of safety engineers employed by the services as well as an increased medical orientation further militates against their role in environmental measurement. They argued that such monitoring was only likely to occur if there was a trade union demand for it that was strong enough to oblige the employer to request such monitoring be undertaken by a prevention service.

Sweden 331 being undertaken. Trade union sources further suggested that greater expertise on monitoring was required within the inspectorate, commenting that while such expertise may have existed in the past, it was much less present amongst the current generation of inspectors. It is partly for these reasons that since its recent reorganisation, the Work Environment Authority has attempted to standardise practices in its ten districts. This has included trying to ensure that, while employers continue to be reminded of their obligations to undertake or to commission measurement as part of risk assessment, the Labour Inspectorate in each district is also technically competent and equipped to undertake them. Indeed, because of a perceived need for more rather than fewer measurements, currently labour inspectors are encouraged to carry them out in situations in which it appears unlikely that employers have the capacity to do so. Trade union interviewees argued that there was regional variation in the severity of the enforcement action that inspectors might take when they discover that workplace exposure levels exceeded OELs. However, the occurrence of such actions overall was so infrequent that it was not feasible to gather evidence to corroborate this claim. It was also agreed that there was variation between sectors in how much monitoring takes place. In larger workplaces in industries such plastics manufacture, motor vehicle manufacturing, in the paper industry and where certain substances are concerned, there is a tradition of monitoring. Generally larger enterprises in these sectors are the main users of monitoring, often having trained employees designated to carry it out. The problem is perceived to lie with smaller companies where there is little knowledge of the risks associated with the chemicals used and even less awareness of the meaning and use of occupational exposure limits. However, unlike in the UK and in Germany, there does not appear to have been a particularly prominent or documented development of strategy on chemical risk management with special reference to the recognised problems of addressing the subject in smaller enterprises and the role of OELs in this process. At the same time, awareness of the nature of the challenges involved appears to be widespread amongst the regulatory authorities and social partners.455

Indeed, the social partners have been involved in pprofducing joint guidance on the subject such as for example, the Chemical Guide, www.prevent.se/kemiguiden, an interactive web-tool, assisting especially small companies in finding out what is required from them and how can they go about fulfilling the requirements.

332 Beyond Limits Interestingly, both the Work Environment Authority and the trade unions commented on the significance of the role of regional safety representatives in increasing awareness of chemical risks in such workplaces and also in working in co-operation with the labour inspectors to identify and resolve problems. Although there is variation between industries and regions, generally regional health and safety representatives meet fairly regularly on an informal basis with labour inspectors to decide on strategies for dealing with risks such as those from handling and using chemicals in small enterprises. They are an important source of information for the inspectorate, since, as has been demonstrated in previous studies, they are far more numerous and visit workplaces considerably more frequently than the labour inspectors - especially the small and micro-enterprises (see Frick and Walters 1998 and Walters 2002).456 They therefore can and do alert the inspectors to the existence of problems as well as playing a significant role in resolving other problems without the need for the engagement of the inspectors. In practice employers tend to use the manufacturers and suppliers of chemicals as their major source of information and guidance on the safe use of chemicals. According to the legislation and regulations, suppliers are obliged to provide information about the risks of their products and how to use them safely - as in other countries they do so by providing material safety data sheets. The Swedish Chemical Inspectorate457 control the suppliers and it is emphasised by the authorities that the suppliers and manufacturers of chemicals should be consulted about safe use. However, unlike the experiences reported in the UK (see Chapter 4), there do not seem to be developed or documented regulatory strategies in which supply chain relationships feature significantly as levers to promote good practice amongst users of chemicals. Manufacturers* information can, in theory, be used by employers and trade union representatives to reduce risks of exposure to airborne chemical contaminants by supporting the choice of safer products. Since manufacturers and suppliers of new machinery also have information on the performance specifications of machines, including performance in relation to airborne contaminants resulting from their operation with regard to relevant OELs, this source is also important in decision-making during the purchase and installation of new machines. In addition, a risk assessment is required when new machinery is installed, thus providing an opportunity to measure performance and check against standards such as OELs. Both trade union officials and They are more numerous in terms of numbers of individuals, but since most RSRs are part-time there are still more full time equivalent inspectors (nearly 400 full time equivalent inspectors compared with320 full time equivalent RSRs). www.kemi.se.

Sweden 333 labour inspectors interviewed pointed to the possibility of these factors influencing decisions on the purchase of machinery. However, it was also pointed out that machinery itself is often manufactured outside Sweden and that low-emission machines may be difficult for users to find. Trade unions pointed to the role of well-informed and well trained health and safety representatives are enabled to participate in such decisions and to influence outcomes. However, neither unions not inspectors were able to provide evidence of the extent to which such practices might occur. Furthermore, trade union sources also pointed out that employers, especially those responsible for small enterprises that are struggling for survival often do not consult health and safety representatives, buy and install second-hand machines for which such information is lacking and moreover, do not undertake the required risk assessments on installation. Work Environment Authority strategies. Awareness of the problems of dealing with compliance across all the regions and sectors has prompted the development of current strategy within the Work Environment Authority. In terms of chemical risks and OELs it is concerned with what to measure and how and in what form to promote the education of competent persons within organisations to undertake measurement. It also clearly wishes to promote the education of employers themselves concerning chemical risks and the role of OELs and it supports the education of its own inspectors. It recogmses there is still considerable need to reduce variation in understanding and practice at the regional level. Part of the strategic approach therefore includes efforts to achieve consistency across the ten districts. As a result there are joint projects on measurement between the centre and the district levels of the inspectorate as well as efforts to co-ordinate sharing experiences across districts. For example in certain districts a considerable amount of measurement undertaken of exposure to wood-dust, while in other districts measurement is far less. Sharing experiences and expertise in this respect helps to promote better understanding of the nature of the problem of wood-dust exposure and helps improve the strategic approaches to achieving compliance. The Work Environment Authority would like to be able eventually to create an inventory of chemical usage in each region. It believes that it would then be possible to have a more systematic approach in the case of required measurement of exposure levels. It would also be able to match requirements for competence amongst employers, prevention services and the inspectorate, with needs for measurement in different sectors and regions. Wood-dust, As recent priorities for the Work Environment Authority have included hypersensitivity and current priorities include a focus on the timber industry, wood dust has been of some concern. The strategy of the inspectorate towards compliance with

334 Beyond Limits exposure standards for wood-dust therefore should provide an instructive example of the role of OELs in inspection practice. It was apparent from interviews with labour inspectors and WEA officials that achieving better control of wood-dust was perceived to be the focus for the inspectorate, not measurement and monitoring of exposure levels. In the Stockholm district for example, a strategic aim was for inspectors to visit all furniture makers. While there was a concentration of visits made by inspectors and a demand made for improvement, the use of OELs is not in the forefront of inspection activity. This is aimed more at encouraging employers to reduce wood-dust exposures at source. As in similar situations, described previously in the Netherlands, there is a perception that where serious problems of airborne dust occur, they are obvious and it is equally obvious when effective control measures have been introduced. Neither requires systematic monitoring to define their nature or effectiveness. Also the costs of such monitoring may be high and it is often argued that money would be better spent on solving or preventing a problem that can be largely identified by means other than monitoring. Enforcement, when it occurs, is therefore far more likely to be concerned with achieving such engineering control as improved exhaust ventilation than it is with measurement of OEL. There is also a strong emphasis on educating employers concerning risks in the use of products and processes that generate wood-dust. According to both trade union and Work Environment Authority sources, OELs for wood-dust therefore do not feature significantly in enforcement actions in the woodworking industry. They maybe quite important in setting specification standards for air quality to be achieved by new machines, in such cases manufacturers should therefore take them into account and they should feature in the specifications of such machines, in decisions concerning their purchase as well as in risk assessment during installation. How much this occurs in practice however is another matter. In many parts of the woodworking industry that are dominated by small enterprises struggling for economic survival, the same general problems as discussed above concerning the absence of attention to OELs in the purchase and installation of second hand machinery were known to apply to employers who are largely ignorant of the health effects of wood dust and the role of exposure limits.

Sweden 335

CONCLUSIONS The Swedish system for setting and using OELs has enjoyed a relatively long history of independent development in comparison with many of the other systems in the countries of the EU. It is also one in which OELs traditionally tend to be set lower than in other EU countries and in which there is a marked distinction between the processes for deriving the scientific basis for a limit and those for its economic/technical basis. Nevertheless, it is clear that it too, is not without problems of implementation and operation. For example, poor awareness of OELs amongst employers, especially in smaller enterprises, is of concern to the Work Environment Authority. Systematic health and safety management is the central strategic objective of the Work Environment Authority. It wishes to make OELs a more integrated part of risk assessment in this process. At the same time it recognises a general problem of awareness about the existence, role and use of OELs amongst employers that continues to thwart their more systematic use, A related issue is the reduction in capacity of prevention services to undertake measurement of OELs. This seems to be influenced by both the absence of a clear regulatory definition of what should constitute the technical resources and role of occupational health services (unlike for example in other Scandinavian countries such as Denmark, where they are more clearly prescribed) and the increased trend towards the commercialisation of such services. The combination of these two influences means that occupational health services are driven by market forces to provide the kind of service that employers want and are willing to pay for. Employers, especially in smaller enterprises are generally ignorant of the role and significance of OELs, therefore they frequently do not require monitoring from prevention services, preferring instead to concentrate their requirements more in areas such as medical surveillance.458 This in

Clearly there are exceptions to this, especially amongst large employers in industries where there has been regular and long-term use of hazardous chemicals such as for example in car manufacture, in some parts of the plastics industry and in paper and board. There are also exceptions in relation to specific substances for which there is a high level of public concern about risks associated with using the. Currently for example, substances such as styrene and isocyanates fall into this category and may be the subject of more intensive monitoring. However, in both such cases the role of trade union representatives in demanding monitoring appears to be quite

336 Beyond Limits turn has a long term effect on the capacity of such services to deliver more broad based preventive approaches including those associated with the detailed monitoring of OELs that should be part of risk evaluation and control for hazardous chemicals. These problems are further compounded by the general lack of access of small enterprises to prevention services. Countering these infrastructural weaknesses to some extent is the role played by organised labour in the regulation of work environment issues throughout the Swedish economy - and especially at the workplace level. Trade union health and safety representatives, whether representing employees of the same employer or operating regionally, include amongst their numbers many who are well trained and well informed.459 They exist in substantial numbers in comparison with either health and safety specialists of prevention services or labour inspectors. Chemical risks and the understanding and use of OELs feature in trade union training programmes on the work environment and in the information trades unions produce for their health and safety representatives, or to which they facilitate their access. For all these reasons it is likely that trained representatives have a significant role in promoting, monitoring and sustaining good practice in managing the risks of hazardous substances at work. The evidence of both work environment officials and trade unionists interviewed strongly supported the idea that the activities of trade union health and safety representatives within workplaces, either through their direct dealings with employers or through their relations with the labour inspectorate, formed a significant pressure instigating employers to monitor compliance with standards necessary for the management of the risks of hazardous substances. Moreover, since an important part of the regulatory provision for workers* rights to representation on health and safety includes the rights for trade unions to appoint regional health and safety representatives and for these representatives to have access to all workplaces where there are trade union members (between 80 to 85 per cent of Swedish employees belong to trade unions) this also may go some way towards offsetting the problems of understanding and use of information on chemical risks (including on the role of OELs) in small enterprises.

significant and they suggest that without such pressures both employers and prevention services would probably do less rather than more monitoring. This is especially so in the case of senior health and safety representatives and for many regional health and safety representatives.

Sweden 337 A further issue relates to the meaning of the OEL. Although the legislation and the official guidance is clear that OELs adopted within the Swedish system are not solely health based, nor therefore 'safe levels', according to the officials of the Work Environment Authority, labour inspectors have in the past had no formal power to demand further reduction in exposure levels if the employer is able to demonstrate that measurements shows exposure to be already below the OEL. There is some interesting case law here which suggests that employers have been able to defend the position that they have done all that is legally necessary of them if they are able to demonstrate that they are working within limits defined by the OEL - even when the labour inspector believes it would be technically and economically feasible for them to reduce exposures to much lower levels.460 Clearly such success conflicts with the theoretical position and official guidance on the meaning of OELs and sends ambivalent messages concerning their use. This is especially so since Swedish OELs are based on comprehensive and elaborate summaries of the toxicological literature. Division of the standard setting process into two distinct parts - one scientific and one regulative, aids distinction between the health and technical/economic grounds for setting them. The limits themselves are on average lower and therefore more protective than in other countries. Nevertheless as Hanson (1998; 98-102) has demonstrated, despite these positive aspects of the Swedish system, the regulatory ratios461 for many substances are too high for the exposure limit to protect It was suggested dining interviews with officials of the Work Environment Authority that in future the approach to persuading employers to reduce exposures to as low as is technically feasible below the exposure limit would be to use a combination of legal requirements drawn in part from those on exposure limits but also from other ordinances on more general measures to limit air pollution. However the introductory paragraphs to the OEL list make it clear that air in the work environment should not be unhealthy and in any case not more polluted than indicated by the standards provided in the OEL list. In a case in 1996 (1996-12- 05), the National Board acted to repeal a notice from a labour inspector to a firm (Setrab), to reduce exposure to gases at their workplace to levels well below the OEL, because of evidence of medically documented health problems at the OEL, arguing that the companies should be given a level playing field for OELs and therefore it was not acceptable to order some companies to reduce them further than others when there were alternative strategies (such as personal protection) that could be used. (Source; Frick, K. National Institute for Working Life (NIWL), personal communication). A term that Hanson (1998) uses in his discussion of the limitations of OELs as indicators of safe levels of exposure. It refers to the quotient between the OEL and the reference level (i.e. the lowest concentration at which adverse affects appear or the highest at which no adverse affects are yet

338 Beyond Limits against the critical effect of the hazardous substance and the limits are therefore not standards that will protect all workers adequately against hazardous substances. So what is the role of OELs in practice in Sweden? Although the statutory provisions on monitoring are quite clear, it is recognised that there are problems with achieving good compliance with them. These are partly cultural and partly resource based, and there appears to be a link between them. At the same time it is not apparent to what extent or how strictly the labour inspectorate has enforced such requirements in the past or indeed is likely to do so in the future.'162 Most interviewees, having identified the various weaknesses in the system that we have discussed here, nevertheless felt that the OEL has an important role. A loose synthesis of their views indicates four possible reasons for valuing the existence of OELs: -

They provide a standard for monitoring exposure to hazardous substances and therefore can be indicators of compliance with requirements for the systematic occupational health and safety management of hazardous substances. Their role in this respect may not be pursued rigorously everywhere, but its existence is nonetheless important. It is useful in situations in which employers have the resources to undertake such activity and may also be a useful tool for regulatory authorities and practitioners who are seeking improvements at the 'dirty end' of industrial activities. Compliance with such standards therefore remains a useful indicator of good practice even though not in ubiquitous use.

-

They provide an important informative and educative role in raising awareness on chemical risks. Even though there is considerable ignorance of their detailed meaning (and in some cases of their very existence) they are nevertheless an important reference point and objective standard for informing discourse on prevention strategies.

-

They act as a norm, especially for larger employers. These (usually) comply voluntarily with OELs and other ordinances, but they nevertheless like to be

observed). Thus, for example if an OEL of 10 ppm is based on the observation of the presence or absence of a health effect at lOOppm then the regulatory ratio would be 0.1. We were unable to obtain any detailed records of enforcement actions or to compare their frequency or seriousness with enforcement actions on other aspects of health and safety at work. However, interviews with both the Work Environment Authority and the trade unions suggested that such enforcement was relatively limited.

Sweden 339 told by authorities, such as the Work Environment Authority, what is right and what is wrong, and thereby also to have 'a level playing field'. -

While monitoring airborne exposures may prove difficult, OELs are an important feature of suppliers' information about the use of hazardous chemicals. They are important in determining specification standards, in the approach to risk assessment and in alerting employers, workers and their representatives to the need to take seriously risk management issues involved in processes concerning the use or substitution of such substances. They apply not only in the case of use and handling of hazardous substances themselves but are also helpful in determining risk management issues concerning the purchase and installation of new plant.

— They may have other important uses such as in claims for compensation resulting from work-related mortality and morbidity. The problems with many of these uses of course, return us to debates concerning the scientific uncertainties on the levels of protection afforded to workers by OELs, the degree of clarity with which their meaning and their limitations are presented and understood and the extent to which substances with OELs are representative of the full range of substances and the risks associated with their use at the workplace. These are issues that we will take up in our concluding chapter.

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10

BEYOND LIMITS? — THE PLACE OF O E L S IN THE NEW REGULATION OF CHEMICAL RISKS IN EUROPE

INTRODUCTION In this final chapter we draw together the various threads of our investigation on current procedures for setting and using OELs in EU Member States and the methods and practices for achieving compliance with them. We set our findings in a wider discussion of the role of OELs in the regulation of occupational health and safety management more generally and we attempt to determine the continued relevance of OELs to present day strategies to achieve improved chemical risk management across all European workplaces. Since it is fundamental to the analysis of any strategic position on OELs, we begin by asking once again, what are OELs for? We continue with an exploration of their role in regulatory approaches to risk management drawing mainly on the conclusions of our country studies. We consider the significance of the regulatory framework and the role of inspection as well as the infrastructural support for monitoring exposure to chemical hazards and we identify some of the limitations of both past and present systems. We conclude by noting some of the considerable parallels in national systems and indicate the lessons suggested by these experiences in common. The two linked and key questions around which our discussion revolves concern: -

What drives informed and competent risk management in chemical safety?

342 Beyond Limits -

What is the role (if any) of OELs in this process?

There are a number of pragmatic but none the less important reasons that appear to be informing regulatory inspectorates and their equivalents in their development of strategies to regulate risk management of hazardous chemicals. They are set within wider strategic approaches to regulating workplace risk management generally and cannot be fully understood in isolation from this context. They to revolve around what is regarded as possible and practicable in terms of preventive approaches for managing risks chemical risks that might be undertaken by duty holders who are limited in their willingness and capacity to either understand or use the sophisticated notions of measurement of performance implied by a professional conception of OELs. They may also reflect the recognition of the limited resources available for the regulatory agencies to intervene in ways that would extend the use of OELs as performance standards. These 'pragmatic' prevention strategies have often been arrived at in agreement with trade unions and employers associations in the sectors they concern and thus their pragmatism is one shared by both representatives of employers and workers. There is quite clearly a theoretical role for OELs as indices against which the measurement of hazardous substances may be undertaken in risk assessment and systematic management of health and safety. However, based on our findings in all of the countries we examined, we question the extent of the reality of this role in practice. The pragmatic and practical issues confronting inspectorates that monitor compliance with regulatory strategies to improve risk management of hazardous substances we think are in part responsible for the development of the new orientations to regulation observed in some of the countries in our study. These new orientations have major significance for the continued role of OELs. As we commented in Chapter 2, there are other, wider reasons for these changes that need to be taken into account. Moreover, although there are developments at EU level that can be related to the same changes, such as the so-called REACH proposals, those within the member states we have studied are not a harmonised response to supra-national requirements. We discuss the significance of these issues in the concluding section of this chapter, noting their impact on the role of OELs. We suggest that while it is not certain how OELs will be used at the workplace level in the future, it is quite clear that such use will remain bounded by issues of understanding and resource availability. Strategies to order the management of chemical risks by legislative, economic, social and regulatory drivers will need to address this adequately in their operation in practice.

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WHAT ARE O E L S FOR? Legislation on health and safety in the use of chemical substances in all EU countries is usually in the form of some kind of framework provision supplemented by more specific requirements. Provisions emphasise process-based approaches to the management of risk to a greater or lesser extent in all national systems. National organisations for securing and monitoring compliance with these legal requirements are also present in all countries. They usually operate under the authority of a central Government Department or Ministry and mostly have some form of overall responsibility in both the setting and enforcement of OELs. There are differences between countries, for example, in the extent to which national authorities are regionalised, deal exclusively with health and safety, have specialised resources for chemical safety and are sole enforcing authorities. In the countries in our study two particular exceptional situations can be mentioned and both have implications for the way that health and safety management of hazardous substances is regulated in those countries. One is the dual German model where social insurance associations also have rule making and enforcement authority in addition to that of the state inspectorate. The other is in Italy, where although the Labour Inspectorate have a national responsibility for health and safety under the Ministry of Labour, in practice the task of seeking compliance remains with regional and local structures of the public health system, under the Ministry of Health.463 Within national regulatory systems there are strong similarities between the various structures and processes for setting and achieving compliance with OELs in the EU. Similarities are also evident in the role of national research institutes for health and safety, which play a strong, independent, advisory role in the setting and adoption of OELs in most countries.464 A further similarity is in the way in which national structures for setting or adopting OELs allow for considerable stakeholder participation. However, these similarities do not entirely override national differences apparent in the setting, status and use of OELs as well as in their legal context. There are also broadly comparable scientific/occupational hygiene treatments of the limits themselves in terms

Arguably this has contributed to a strong focus on technical standards in Germany, while in Italy the absence of substantial leadership from any central national authority has contributed to considerable regional diversity in regulatory practices in relation to chemical hazards. The UK. is somewhat exceptional in the EU in that it does not have a national research institute for health and safety comparable with those found in most other EU states.

344 Beyond Limits of the use of time weighted averages, short-term exposure limits, ceiling values and annotations for special risks such as carcinogenicity, skin absorption, allergenic substances etc. But although there is widespread use of similar terminology, there are differences in the detail of the way in which it is used in relation to different substances in different countries. There are also differences in the degree of sophistication and support for national systems and the extent to which they are capable of undertaking their appointed tasks. Generally those systems that have been in place longest, such as the UK, Dutch, German and Nordic ones, would appear considerably more robust than those of more recent origin, especially those of Southern European countries. Perhaps the most significant difference that is relevant to our interests is found in the German system, where the technical orientation and the extensive provision for surveillance through both the state inspection system and that of the BGen means that there has been considerably more monitoring of exposures in relation to OELs by these organisations than we were able to document in any of the other countries in the study. The problems of understanding and use identified by previous research on the UK situation are largely borne out by experience in other EU countries. In the legislation and official guidance of most countries it is made clear that OELs are not solely health based, nor therefore 'safe levels'. Division of the standard setting process into two distinct parts - one scientific and one regulative, aids distinction between the health and technical/economic grounds for setting them. The general principle is that exposure should be as low as is possible and OELs, whether legally binding or otherwise are indicative of what should be achieved but not necessarily all that should be achieved. Nevertheless, tendencies to regard them as 'safe levels' are persistent and are expressed to varying degrees by both employers' and workers' organisations. In all countries it is recognised that small company owner managers generally have limited awareness and understanding of the meaning of OELs and therefore little capacity to apply them adequately in their risk management strategies. Their capacity to do so is also severely constrained by their limited access to support from the expertise of prevention services. This situation begs the question 'What are OELs for?' From our review of both the structures and processes for setting OELs in the EU and their use in the countries we have studied in more detail, it would seem that the answer is that they have a variety of functions: -

They are used as reference tools for monitoring systematic management of chemical risks in larger organisations where there is experience and support for such a task either within the organisation or through the use of technical assistance from external prevention services/occupational hygiene consultants.

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Clearly this is important in sectors of industry where dangerous chemicals are in use, where substitution is not possible and specification standards for machinery and processes do not mitigate the need for monitoring performance standards. Their use in these situations may have some benchmarking value for other workplaces, however, strong evidence of widespread transfer of good practice is hard to find. Their use as reference tools in monitoring workplace exposures in such firms is also a useful indicator of adequate risk assessment for regulatory agencies in enforcement practices in firms in which hazardous chemicals are in use and where it is suspected that exposure levels are high. Their role may not be pursued rigorously everywhere, but its existence is nonetheless important and particularly useful in seeking improvements at the 'dirty end' of industrial activities. Compliance with standards for which OELs are a reference point remains a useful indicator of good practice. They are also useful reference tools, from a scientific/technical perspective, for large scale surveillance of exposure such as has been practiced in relation to various substances in Germany, and which has helped to contribute to understanding concerning the health effects of exposures and the consequent need to reduce them. They provide an important informative and educative role in raising awareness on chemical risks. Even though there is considerable ignorance of their detailed meaning (and in some cases of their very existence) they are nevertheless a reference point and objective standard for informing discourse on prevention strategies. They may also be useful norms for larger employers to follow. While monitoring airborne exposures may prove difficult, the existence of OELs is an important pressure on suppliers to provide information about the safe use of hazardous chemical products that acknowledges and makes use of their OELs. As such they have a role in several different loci in risk assessment cycles. Moreover, they are important in determining the approach to risk assessment and in alerting employers, workers and their representatives to the need to take seriously risk management issues involved in processes concerning the use or substitution of such substances. A caveat concerning their use however concerns the need for a proper understanding of their meaning. That is, for example, if the notion that they represent safe levels, or even values above or below which dramatically different effects occur are persistent they undermine the value of OELs and contribute to their misuse.

346 Beyond Limits -

Provided the caveat concerning proper understanding of their meaning applies, they may have a helpful role in defining specification standards that can be used in determining risk management issues concerning the purchase and installation of new plant. In some situations where monitoring is anyway extremely unlikely, such specification standards may obviate the need for its use.

While these are all positive uses, they also need to be seen in the context of the enormous levels of ignorance about OELs amongst users of chemical products. British research has demonstrated this quantitatively (HSE 1997). We were not able to match these quantitative estimates of ignorance amongst employers with similar quantitative studies in other countries, but nevertheless there was a strong consensus in the literature and amongst interviewees that the same situation prevailed. This of course leads us to question the extent to which the above ideal scenarios of OEL usage actually occur in practice. It also helps to explain the strong orientation amongst prevention specialists, trade unions and regulators towards the use of substitution, specification standards and technological development as means of dealing with chemical risks. And as we have already noted in the introduction to this chapter, it partly explains the preference of modern regulators in some countries for a move away from a central role for OELs in monitoring compliance. It should also be mentioned that OELs are sometimes subject to uses for which they are less appropriate and for which there seems to be no scientific or ethical justification. Aside from frequent abuses arising from ignorance or misunderstanding of their meaning, further examples of misuse include their involvement in determining situations in which additional bonus payments for unhealthy working conditions have been negotiated such as in Greece, and their somewhat dubious role in cases involving compensation claims for work-related mortality and morbidity, as well as their use in redundancy settlements as in the case of previous work with asbestos in Italy. Additional to these uses and abuses, is the situation in which the adoption of EU systems for setting and using OELs is perceived to be at odds with a country's traditional approach to regulating the management of chemical risks and which therefore gives rise to a level of concern about the meaning and role of OELs as legal standards. Thus, interviewees in Italy articulated a worry that national adoption of EU 'pragmatic' standards that take economic considerations into account will undermine the Italian workers' constitutional right to healthy and safe workplaces. According to this argument the assumption of a level of risk that is implicit in such standards is fundamentally at odds with workers' rights to health that are enshrined in the

Conclusions: Beyond Limits 7A1 347

constitution. Italy was the only country in which this specific concern was expressed and arguably this is because it is the only one in the study where such rights are constitutionally defined. It is therefore a constitutional problem that may not have widespread application outside Italy. And in Italy itself, its significance is moderated by the considerable variation in regional practices and infrastructural support for health and safety. However, it is nevertheless indicative of the important changes in meaning that occur when OELs become part of the regulatory system. It is also related to other perceptions of the problem of the meaning of OELs, that are evident in all countries. Comments received from regulatory inspectors in countries such as Italy and Greece, but also in northern European countries such as Sweden and the Netherlands, suggest a concern that giving OELs a form of regulatory status created both the potential for misinterpretation and at the same time placed equally unwanted limitations to inspectors' discretion. In such circumstances the existence of an OEL is sometimes viewed as an unhelpful distraction from the main business of improving the work environment. As a consequence it is marginalised in the regulatory inspectors' armoury of inspection tools for reducing exposures to as low as is technically possible. We saw hi the case of the UK that such concerns are amongst those responsible for causing regulators to reappraise the position of OELs in regulatory strategies and that developments in recent years such as the focus on control banding and using simplified methods of chemical risk assessment have been a pragmatic acknowledgement of the failure of the central focus that was given to OELs in the control strategies of the 1980s andl990s. They are also behind the more recent move in UK provisions to both simplify the framework for OELs and to ensure that compliance with an exposure limit is not regarded as an alternative to applying good practice and reducing exposure as low as is reasonably practicable. As we discuss further in the following section, similar conclusions have been reached in other counties.

THE CHANGING ROLE OF O E L S IN REGULATORY APPROACHES TO ACHIEVING CHEMICAL RISK MANAGEMENT The regulatory framework. The predominant pattern in the countries of the EU is for an OEL to have some legal definition within the application of more generic health and safety legislation. Thus, in most countries authorities report that there are a number of OELs that are legally binding limits. In a few cases these appear to be restricted to those that are in force as a result of compliance with EU Directives but in many cases the list is longer. We have not looked at the full lists of exposure limits for each country in

348 Beyond Limits depth, but we have noted from the available literature that while broadly comparable, there are differences in detail, both with regard to the number of substances included and in some of the values set. However, we also note that the significance of such differences as an influence on practice is uncertain. They do not, for example, appear to have had any material bearing on the extent of measurement or its enforcement in the countries studies. Nor do they appear to be the cause of any differences in strategies on the part of the regulatory agencies to improve compliance. In all of the countries in the study post-Framework Directive moves towards process regulation of OHS management dominated the approach to regulation by the regulatory agencies. Thus, their regulatory strategies were focused on the means of securing compliance with a systematic approach to health and safety management rather than with breaches of individual provisions. As we have already indicated, OELs could play a role in such strategies as reference points against which compliance with systematic approaches to risk management for hazardous chemicals might be monitored. Such an approach may have occurred in some cases as is evidenced in Sweden, where regulatory authorities pointed out that measurements were made or checked by inspectors where it was suspected that OELs were in danger of being exceeded and in Greece and other countries where there was evidence of occasional enforcement actions in which proof of compliance with OELs was mandated. However such instances were exceptional. Far more significant in the strategies of the regulatory inspectors was the notion of a holistic approach to OHS management. This took a variety of forms in which arrangements for chemical hazards might be included. For example, in Greece considerable regulatory attention appears to be focused on trying to establish whether firms had made contractual arrangements to use prevention services or individual prevention specialists. In the Netherlands and Sweden where such arrangements were also important (and considerably better developed), chemical hazards were frequently subsumed into broader reviews of risk management especially in small to medium sized enterprises. Dealing with chemical risks in these contexts involves a complete cycle of risk management approaches ranging from the availability of suppliers' hazard data information, through specification standards for machinery and processes to the possible requirement of evidence of performance standards in relation to OELs in the auditing of effectiveness of risk management measures. In practice however, the latter seem to be seldom invoked and not infrequently, simpler indicators of performance were sought.465

465

Such as for example visible evidence of the presence of wood dust, or simplified occupational hygiene measurements, as in the Netherlands (see Chapter 8).

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In the UK the revisions to the OEL Framework that come into force in 2005 were undertaken in the light of the limited application and understanding of relevant requirements in the previous versions of the COSHH regulations, especially in small and medium sized firms. As we demonstrate in Chapter 4, they are part of a strategic approach to regulating chemical risk management in which an essentially pragmatic recognition is afforded to the need for simple, workable solutions that employers in these kinds of organisations are thought likely to have both the will and capacity to implement effectively. At the same time the architects of the reforms claim there are sufficient safeguards in their approach to ensure the adoption of principles of risk management that are appropriate according to the risks posed by the particular chemical substances in question. Nevertheless, as we also saw in Chapter 4, critics have argued that the approach is a capitulation in the face of insufficient resources in the health and safety system to achieve anything more meaningful. Also strongly in evidence in some countries such as the Netherlands and Italy for example is the considerable attention regulatory agencies pay to gaining sectoral or regional/sectoral level agreement between representative bodies of employers and workers for OHS management improvements in particular industries. Typical of these initiatives are the sectorally based 'covenants' in the Netherlands in which specification standards on emissions for machinery and substitution principles for chemicals may be introduced. On a smaller scale, in Italy as well as in other countries, such 'partnership' approaches involve inspectors in negotiations on health and safety management with representatives of employers and workers at local/sectoral levels where the local density of small firms involved in similar activities make an agreement concerning the health and safety aspects of particular processes (including chemical hazards) especially viable. Again, in these situations the technicalities of monitoring and OELs are likely to be substituted by specification standards and simpler measures of performance. A linked approach also much in evidence in Germany, Sweden and the Netherlands is the policy of regulatory agencies to focus on 'projects' in health and safety issues, which might concern specific processes, machinery, industries, or health effects such as sensitization, or localities, or combinations of these. Again, chemical hazards, such as those arising from wood-dust or solvents are sometimes the focus of such projects. They generally involve a concentration of regulatory effort on particular sectors and processes, that is intended to result in not only improved OHS management practices in the workplaces that are the recipients of such attention but also, a cascading effect to other workplaces, aided by the publicity for the project, peer group pressure within the sector/locality and the involvement of representatives of employers and workers in the sectors concerned. Although these approaches were much in evidence in the countries

350 Beyond Limits mentioned and interviewees were able to point to local evidence of their success, the success of the desired cascade effects was less clear. An overall approach to regulating chemical risks through using indicators of good practice and safe plant that could be reasonably assumed to indicate low risk of excessive exposure to hazardous chemicals and thus reduce the need for monitoring seems to be most systematically developed in Germany. However, similar approaches were also in evidence in Sweden and the Netherlands. It was only in Germany that we found evidence of a more systematic and large-scale approach in which OELs clearly featured in the regulatory framework and were transferred to workplace surveillance in a systematic manner. As the example of the so-called 'negative list' in relation to the 2 mg/m3 OEL for wood-dust shows, there is an attempt to link requirements to achieve improved exposure levels with evidence of current levels of exposure and arrangements for measuring them. However, interviewees expressed skepticism about the widespread use of such measurements, especially in the small and medium sized firms for which, neither the state labour inspectorates, nor the inspectors of the BG had the resources to achieve significant access. There was also sometimes concern that the role of the different agencies with regulatory powers was potentially competitive rather than collaborative and might result in unnecessary duplication of effort and thereby a wastage of precious resource. In summary then, the regulatory framework for managing chemical risks in the workplace that is developing in EU 15 member states has in common an orientation towards process regulation in which the impact of the principles behind such wider EU measures as the Framework Directive 89/391 is evident.466 Amongst the more legislatively advanced northern European member states these principles co-exist with specific strategies for achieving improved chemical risk management either through generic approaches towards control banding such as in the UK or through the related approach to specifying process standards such as operated in Germany. Linked to such approaches are precautionary principles that emphasise controlling risks at source, substitution and even the removal of extremely hazardous substances altogether from the market. There is widespread recognition that all these approaches require the engagement of employers, workers and their representatives in bringing about their effective implementation. Various methods are supported by the regulatory agencies to However it is important to acknowledge cause and effect here too since existing legislative approaches in some member states themselves had a strong influence on the thinking behind the formulation of the principles implemented in the Directive (see Walters (ed) 2002 for a detailed discussion of this point).

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achieve this including sectoral level engagement, special projects, partnership arrangements and supply chain strategies. In all cases in the advanced market economies of northern Europe there appears to be a general acknowledgement that focusing on OELs is somewhat tangential to these ends and that while the institutions and processes for setting exposure limits remain part of the infrastructure of health and safety regulation at national level in most countries, expectations concerning their role in risk assessment and its regulation at the workplace level are quite limited. The notions that lie behind these developing national level regulatory frameworks are also relevant to the thinking at European level that has informed REACH. There are for example similar concerns about getting better knowledge of chemical risks and improved risk management disseminated to users in all of the situations in which chemicals are found in the workplace, and not just to large workplaces in the chemicals industry. The regulatory approach to achieving this under REACH is likely to involve suppliers' responsibilities to provide information that are both more onerous and more comprehensive than is currently the case. It will further involve an obligation on users to ensure that the use to which they intend to put a chemical substance is that covered by the suppliers' information. If it is not, users may be obliged to communicate the nature of the proposed use to the supplier in order that best advice can be given. Thus a two-way communication within the supply chain is envisaged. It is unclear what will be the role for the measurement of exposure in relation to exposure limits in this process. In the studies that have been undertaken in relation to the future implementation of the REACH principles, approaches based on control banding and specification standards in achieving a targeted approach to risk assessment outlined above seem to be favoured.41" While there is some limited support in the literature for the notion that such strategies result in standards of protection that are equivalent to those achieved by monitoring to ensure exposure limits are not exceeded, most of such evidence has been gathered from willing participants in trials to test the scientific validity of the approach. It is therefore not clear how widespread would be their adoption in situations for which inspection and regulatory scrutiny is difficult It also needs to be borne in mind that two-way communication within the supply chain presupposes the, as yet, untested existence of a variety of supports and levers to facilitate and encourage users to engage in such activity. As we pointed out in Chapter 2, present day supply networks exist for a variety of business reasons, many of which are to off-load responsibilities for care that are seen as not profitable. It is therefore far from clear that the same supply networks will automatically lend themselves to be conduits for improving health and safety practices

See for example ECETOC (2005).

352 Beyond Limits of either suppliers, users or their intermediaries without considerable additional pressures to do so. In some cases they may actually militate against such uses. The role of regulation. Breach of requirements relating to binding values is either a criminal or administrative offence (or both) depending on the national regulatory system and the seriousness of the breach. Penalties are most commonly fines, the levels of which are defined usually in the relevant legislation. The extent of the use of such penalties is difficult to determine from existing records. However, interviews with subjects in all countries suggest that, as in the UK, (where some limited empirical study has been undertaken) compliance (or otherwise) with OELs is not a major subject for enforcement action - nor indeed is it even a significant aspect of regulatory actions that involve hazardous chemicals. There seem to be several linked reasons for this, most of which relate to the limited resources of both inspectors and inspected as well as to a perception that there are frequently other, more appropriate means of achieving improved risk management of chemical hazards, such as we have already described. Thus, inspectors often question the relevance of focusing on monitoring OELs in chemical risk management. At the same time they frequently do not have the capacity to do more than demand evidence of measurement, they are neither equipped nor skilled sufficiently to be able to undertake such measurement themselves. Although in most countries, such skills and equipment are possessed by at some level within regulatory inspectorates it is usually as specialist services to which ordinary inspectors may have limited access. In some cases such as in Sweden for example (and also possibly in the Netherlands and in Greece) an effort is being made to distribute such resources more evenly across inspectorates so all regions/sectors can have improved access to them. Furthermore, it is widely understood to be the responsibility of duty-holders to undertake measurement. As we have repeatedly seen, this may be reasonably well acted-upon in large companies that use hazardous chemicals, but such responsibilities are far more seldom exercised by the owner managers of the small enterprises that are also substantial users of hazardous chemicals. Moreover, the training and experience of inspectors themselves is not always adequate to ensue they are all confident in handling the scientific/technical issues involved in the interpretation of monitoring data in relation to OELs. A further factor in the relatively low profile of enforcement actions in relation to OELs in some countries may be the previously mentioned involvement of the regulatory agencies in various means of securing compliance through exemplary projects and especially through voluntary agreements such as the covenants found in a number of sectors in the Netherlands. While by no means limited to issues of chemical risk, these

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initiatives often include chemical risk management as part of their remit and therefore are of some influence on regulatory strategies on hazardous chemicals. There are two aspects that are possibly significant in relation to enforcement. One concerns the extent to which these efforts can be regarded as forms of 'reflexive regulation' in the sense that they represent efforts on the part of the regulatory agencies to encourage forms of self-regulation by agreement between employers and trade unions (and sometimes others such as suppliers or local authorities). This kind of 'regulation of self-regulation'468 often implies a changed approach to enforcement activity.469 Participating organizations, agree to meet particular specifications and to aim for performance targets agreed between themselves, the regulatory authorities and the representatives of their workers, and are spared a degree of external inspection of the minutiae of their activities since they are monitoring their own performance. The nature of such enforcement action that may occur in these situations is more likely to relate to failures in meeting generic systematic OHS management standards than it is to failures in relation to individual requirements such as monitoring of hazardous substances. The second aspect relates to the desire of regulatory agencies to make overall progress in improving health and safety outcomes through cascading the project approach. Interviewees from regulatory agencies in countries such as Italy spoke of the need for greater attention to an advisory role for inspectors in such initiatives and stressed the importance of their educational functions in approaches to improving health and safety through partnership and a focus on a more holistic approach. Again these might result in less obvious enforcement actions in relation to hazardous substances in projects, with the aim that good practice that is achieved with the help of education and advice from inspectors will be passed on to other firms. Of course, it is probably also the case that enforcement actions in which issues of chemical risk management are addressed, including those in which OELs may be implicated, are recorded in ways in which these aspects are not prominent. The emphasis that regulatory agency inspectors and officials that were interviewed placed on 'holistic' approaches to ensuring compliance with systematic risk management, coupled with the difficulties in interpreting recorded enforcement data mean that a considerably more detailed study of inspection practices in process regulation is required before it is possible to make a definitive statement concerning the true extent of enforcement actions in which OELs are involved in the countries studies. However, the See Chapter 2 for an explanation of this term. Indeed, critics argue it implies reduced enforcement activity.

354 Beyond Limits strong impression gained from the interviews is that they are certainly no more significant than has been already demonstrated in the UK (HSC 2002). Who monitors workplace air? While measurement of airborne pollution to assess risks and monitor risk management is the responsibility of employers, in practice it is often undertaken by external expertise. Regulatory inspectorates, (perhaps with the exception of those of the dual system in Germany), rarely engage in proactive acts of monitoring themselves, instead it is undertaken by prevention services and/or a variety of other consultants. A major difference between the UK and most other continental European countries is in the nature of the legislative provisions that oblige employers to use prevention services to support their management of OHS, and the further provisions that serve to define the competence of the services found in these countries - in contrast to the rather limited legislative requirements concerning competence that characterise the British approach. Although there is considerable variation in the detail of these requirements, they exist in most continental EU countries and many have been there for some considerable time. All have played a substantial role in national arrangements to implement the Framework Directive and, in particular, to provide support for risk assessment/management. Not surprisingly therefore, in most countries in our study such services are perceived as having a front-line role in monitoring workplace airborne exposures to hazardous substances. In some countries an additional significant role is also played by a variety of other consultants. In our country studies we were able to identify several problems with this (theoretical) position, which may contribute to undermine its effectiveness.

There is variation in quality and competence of external prevention services/consultants. Although countries such as the Netherlands have certification systems in place that are designed to maintain high standards of competence from prevention services, the effect this has on their capacity to undertake occupational hygiene is not clear. While employers are obliged to contract with an Arbadienst to ensure that the risks of their enterprises are evaluated appropriately and risk evaluation is a statutory requirement for the services that the Arbodiensten supply to support employers, the degree to which such evaluation actually carried out appears to be less than optimal (Karageorgiou et al 2000:277-283). They are commercial organisations and the main market demand for their engagement is directed towards sickness absence and medical surveillance. Therefore it is likely that unless employers demand it, they will not undertake monitoring of workplace air. For the same reasons it is likely that, despite requirements on competence, many of the Arbodiensten may not posses the expertise required for sophisticated monitoring of OELs. Similar concerns were expressed in Sweden where it

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was suggested that, in fact, as in the Netherlands, the frequency of measurement undertaken by occupational health services had declined over the last decade. In Italy there has been considerable debate surrounding provisions (or more correctly, the absence of provisions) to ensure quality of prevention services that are a product of the Law 626 (implementing the Framework Directive 89/391). In November 2001, the European Court of Justice upheld a complaint that Italian legislation did not make the use of external prevention services compulsory where skills within undertakings were insufficient for risk assessment (ECJ Case C49/00 Commission v Italy, 15.11.01). Since then, what should constitute quality in external prevention services has been the subject of on going discussion but it is unclear what, if any, will be the legislative outcome of such discussion or what effect, if any it will have on the capacity of such services to undertake airborne monitoring.

In Greece although much is expected of their role, external prevention services for OHS are a recent development. It is assumed that trained safety engineers and occupational physicians (constituting the specialist personnel of the EXYPP and ESYPP) will: -

reduce the deficit in knowledge in relation to securing improved management of chemical risks within systematic OHS management the extent of exposure future situations that require monitoring.

The EXYPP may provide the technical support to employers to enable them to understand the role of OELs as well as undertake monitoring for them. Increasing demand for their services will increase the need for people trained in monitoring. However, the reality is that at present there are extremely few of such services, they reach only limited numbers of enterprises and it is unlikely they all possess the capacity to undertake monitoring of workplace air. The absence of a clear regulatory definition of what should constitute the technical resources and role of occupational health services (unlike, for example, in countries such as Denmark, where they are more clearly prescribed) and the increased trend towards the commercialisation of such services means that they are driven by market forces to provide the kind of service that employers want. Employers are generally ignorant of the role and significance of OELs the therefore frequently do not require monitoring from prevention services, preferring instead to concentrate their requirements more in areas such as medical surveillance. In countries like Sweden and the Netherlands with prevention services of long-standing, this erodes their capacity to

356 Beyond Limits deliver broad based preventive approaches such as those associated with the detailed monitoring of OELs. In countries where such services are relatively new, the overall pressures are much the same and their effect is to make it unlikely that more than a minority of such services would gain this kind of capacity to begin with. Whatever the capacity of prevention services to deliver monitoring of chemical pollutants in workplace atmospheres, a more significant problem concerns the limited access to such services enjoyed by the majority of enterprises. This seems to be the case regardless of the legislative provisions that control such services and require employers to use them. It is a widespread problem and especially significant in small enterprises. It is generally acknowledged that for a host of reasons these are least well serviced by external prevention services, and relatively inaccessible to inspectorates (Walters 2001). It is therefore far from clear how frequently or how thoroughly monitoring actually takes place in practice in such firms, or with what results. In all these respects therefore despite the existence of more onerous legislative requirements on the establishment and use of prevention services, as far as the involvement of such services in monitoring workplace exposures in relation to exposure limits, the experience in other EU countries we studied is in practice not hugely different from that in the UK. This would seem to suggest that claims advanced by British health and safety professionals arguing that the stronger legislative arrangements in continental European could be contrasted UK experience in relation to professional support for monitoring of OELs have only limited justification (see Chapter 4). One corollary of poor access to and service by expert prevention services is poor awareness of the existence/meaning of OELs. As we have already noted this is a welldocumented feature of owner/managers in many small enterprises that use chemicals in the UK (HSE 1997). There is somewhat of a cyclic effect here - where employers are unaware of the significance of OELs they are unlikely to engage the services of prevention services to monitor airborne exposures. Equally they are unlikely to do so because of the prohibitive costs involved. As such, they will not benefit from any educational/awareness raising effects that might result from contact with prevention specialists. Regulators and trade union specialists interviewed during the study were often only too aware of this cycle and it was one of the reasons why they advocated the kind of alternative strategies we have already discussed - because, to a large extent they remove the need for employers to make informed decisions about risk management strategies for chemical hazards.

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THE WAY FORWARD? A new regulatory paradigm for OELs in chemical risk management?. We have noted that the development of a regulatory function for OELs (as opposed to their previous technical/specialist reference function) has helped to create quite elaborate systems for agreeing OELs at national (and EU) level. In these systems, considerable efforts have been made to ensure clarity in the distinction between scientific deliberations on risks to health and the economic/political discussion of what is feasible in terms of exposure levels at the workplace. But there is a contrast between the sophisticated national systems for the adoption and review of OELs and practices at the workplace level, where in the majority of workplaces that use hazardous chemicals it would seem that OELs play a relatively minor role in day-to-day decision making on risk management. While national level systems (quite rightly) involve wide-ranging expertise and rigorous debate, within many workplaces there seems to be a substantial problem of understanding amongst duty-holders concerning the meaning and appropriate use of OELs. This is a widespread finding in our national studies. In some cases the development of a regulatory function for OELs has arguably worsened the misconceptions about their meaning - illustrated for example by a tendency in many countries to regard the numerical value of an OEL as an absolute distinction between safe and unsafe exposure, by debates about what constitutes a low/moderate/high risk such as in Italy, and by negotiations for exemptions from requirements on the use of competence in chemical risk management for the members of craft associations such as in Greece. These contradictions cannot be separated from the broader issues of transparency, public trust and public understanding of the development of governance strategies for risk regulation more generally. There are a number of related issues here, all of which need to be addressed if a wider appreciation of the strengths and weakness of using OELs in managing the risks of working with hazardous chemicals is to be achieved. And there would seem to be a strong case for considering what can be done to counter the mythology of absolutes that seems to surround the use of numerical values in risk assessment. Even where their meaning is understood, the role of OELs as tools in prevention strategies for chemical risk management at the workplace may still be a relatively limited one. While regulation is widely regarded as an important stimulus, we see quite clearly that technological development is the primary driver of improvements in reducing exposure to dangerous chemicals in most sectors and in most countries that we have studied. We also see that specification standards for processes and machinery play an important part in control strategies, as do estimated exposure scenarios and control

358 Beyond Limits guidance related to them. While OELs have some significance as reference points in the development of specification standards, these standards are often used as evidence that there is no requirement for monitoring to test compliance with OELs in workplaces in which machinery and processes meeting them are in use. In Germany and in the Netherlands for example, in the case of some substances this has meant substitution and closed/recovery systems while in the case of others, the advocacy of the use of abatement systems and other dust reduction facilities as with wood dust for example. The connection between monitoring compliance with the OEL and influencing these improvements is tenuous. In Germany in the case of wood-dust we have seen that the main emphasis of the regulatory authorities and other professional agents of the OHS system concerns designing model work-places that guarantee the compliance with the TRK value, by using recognised abatement and dust reduction facilities. Employers are not required to measure airborne exposure and labour inspectors simply check that certain machines are present and are working in the way they should. Measurement therefore becomes an exceptional requirement rather than a normal expectation. As such, OELs may have an important value in determining the specification standards for machines, but a reduced importance as reference points for routine airborne monitoring - because the argument goes that the need for monitoring may itself is much reduced in such circumstances. Thus, the performance standard paradigm that has underpinned professional use of OELs, is often replaced by the (older) notion of specification standards in the practices of chemical risk management, not only carried out by duty holders but also encouraged and supported by the demands of regulatory agencies. Similarly, the strategy of substitution has the effect of bypassing the need for OELs for hazardous substances, since such substances are, by definition, replaced by safer ones. While this does not exactly render the role of OELs/performance standards redundant, it certainly affects their significance in practical and achievable strategies in risk management and arguably requires a rethinking of their role in developing the philosophy behind chemical risk management at the workplace. As we outlined in Chapter 4 in the case of the UK, the development of the control strategies that are packaged in the COSHH Essentials approach developed in parallel to related strategies to estimate exposure, such as the Estimation and Assessment of Substance Exposure (EASE).470 Together they are claimed to provide a comprehensive EASE originally developed in the UK but is increasingly used in other EU countries. It is a model that postulates that the concentration of a substance can be predicted for a particular situation

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strategy to assess risks of likely exposure and to recommend appropriate strategies for risk management and control in situations where employers for various reasons may not have access to appropriate expertise to monitor exposure and where arguably monitoring is not necessary because likely exposure can be predicted and appropriate controls implemented to prevent harmful consequences (Northage 2005). Converging chemical risk management scenarios in the EU? Although one of the consequences of the growth in significance of the EU as a legislative and policy making body has been greater harmonisation in many aspects of risk regulation, most comparative studies nevertheless stress the continuity of divergence amongst national systems. In common with other authors,471 we are at pains to stress that there are many features of national systems for health and safety and strategic approaches to regulating chemical risk management that remain divergent. However in terms of the role of OELs within these systems, it is the convergence of experiences and approaches that is most striking. This is particularly true of: -

national systems for setting and reviewing OELs and their position of such systems within OHS regulatory systems the limited role of OELs in control measures in use in managing chemical risks and in workplace OHS management the limited extent to which reference is made to OELs in monitoring risks management by the regulatory agencies the limited understanding of the meaning and significance of OELs by duty holders and notions concerning their meaning prevalent in wider society measures that are used in addition to or instead of OELs to determine control measures and good chemical risk management practice.

where exposure data is not available though analogy with similar situations provided that judgements are calibrated with reference to sufficiently robust measured exposure data. It seems that despite some recognised limitations, the development of this approach over the past decade or so has resulted in a model that most commentators regard as reasonably accurate for inhalation closures (Tickner et at 2005). This is not the place to discuss the convergence/divergence debate in detail. However the point about continued divergence in national systems after the imposition of the harmonising effects of EU Directives is discussed at some length by for example, Walters 2002, Vogel 1993 and 1998, and Unger and van Waarden 1995.

360 Beyond Limits Convergence is also apparent if we compare the salient points of our conclusions with the key objectives for the revised British system that were identified in the HSC's Discussion Document that led to the introduction of the revised OEL Framework in the UK in 2005. It will be recalled from Chapter 4 they were that OELs should: -

control risks to health be readily understood and accessible be legally enforceable comprehensive comply with EC legislation flexible and able to take on board new developments in science and technology provide incentives to reduce exposures.

Controlling risks to health was clearly the aim of all of the OEL systems we investigated. The extent to which they were able to do so however, was subject to considerable limitations, of scope, application and user understanding that are similar to those experienced in the UK. None of the systems we investigated had been subject to any detailed quantitative evaluation concerning their effectiveness either in terms of health outcomes or, more narrowly, in terms of their use in risk assessment.472 The qualitative evaluations on which we drew suggested broad agreement about the limitations of OELs but at the same time pointed to a widespread belief in their necessity. There were variations in the extent that it could be argued that OELs were based on clear and coherent principles but general agreement that nowhere were they either readily understood by the majority of employers or accessible to them. As far as professional input in their use was concerned, despite the existence of legal requirements on prevention services in most of the countries we investigated, there was shortage of professional input in the application of OELs in workplaces in these countries (Germany is a possible exception). There was a widespread notion that such input was least accessible to employers in small and medium sized enterprises and that these were the duty holders that were least aware of the significance and role of OELs. There was also a worrying notion expressed in some countries that there had been a

The field work for the study was undertaken before the cost/benefit studies on the likely economic impact of REACH were published. While none of these studies concern themselves specifically with the role of exposure limits, they do address the extent of ill-health related to exposure to chemicals and to some extent evaluate the capacity of existing systems to reduce such harm.

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decline in the extent to which prevention services still had the capacity to provide the professional input required. In the UK a new national approach to the provision of advice and information on occupational health and safety is scheduled to commence operation in 2006. Known as Workplace Health Direct, it is based on a model that has already been piloted in different regions and industries and comprises a three level scheme that is intended to provide confidential health and safety and return to work advice to employers, including those in small and medium sized firms. The first level will be a national telephone advice service, the second, a* problem solving service at regional level while the third, will be a signposting service whereby employers who are in need of specialist advice will be referred to independent consultants such as occupational hygienists, ergonomists or other specialists. The model offers interesting possibilities when viewed in conjunction with schemes on chemical risk management such as COSHH Essentials that are already operating in the UK and clearly there is a conceptual fit between its approach to providing increasingly specialised advice at three levels and the kind of support that employers might need to deliver appropriate risk management strategies for chemical use under REACH. However, the scheme is not yet operational, there are some uncertainties concerning the level of funding it would need to function effectively and what would be the likely balance in the sources of such funding - or indeed what would need to be removed from the existing system for occupational health support in the UK in order to resource it. OELs were theoretically legally enforceable in all countries. The extent to which they are enforced however is limited. Records are hard to locate or understand, but the strong evidence of observers was that in all countries enforcement, for many reasons that have already been discussed, is not an option practised widely. At the same time, regulation is widely perceived as an important driver of improved chemical risk management, however, OELs are only one aspect of such regulation. Systems for setting OELs in northern Europe are sophisticated and highly developed. But even the most developed systems only deal with a small minority of chemical substances that are in use in industry. None could be said to be comprehensive in coverage. There is therefore discussion of the means with which such frameworks for OELs could be applied to generic groups of substances. Generally in these countries, strategies of substitution are based on quite thorough investigation of possible effects of alternative substances and the ethos of substitution is not one that would encourage the introduction of inadequately evaluated and potentially harmful substances.

362 Beyond Limits Compliance with EU level requirements is an issue that is under review in all countries. The anticipated division between north and south is also evident here. The concerns of northern European countries are with the extent to which existing systems need to be adapted and the extent to which the achievement of compatibility with EC requirements can be achieved without reducing the quality of these existing systems, m southern European countries EC requirements are sometimes necessitating more fundamental reforms. There is some questioning of compatibility of these changes with national approaches (such as the constitutional debates in Italy) and the possible influence on quality. In addition, there are several other issues that are the subject of national debate in Italy and Greece which seem to be mainly to do with the extent of duties under the legislation introduced to transpose the EC requirements and the possibility of exemptions from its coverage. There was some concern in these countries about delays that occurred in the process of review and the resource intensive nature of the process of evaluating new information and reconsidering OELs in its light. OEL systems were generally flexible enough to allow for the development of substitution and specification standards. The position in relation to the discretion of inspectors to demand improvement of exposures to below the OEL was less clear. Concerns were suggested about the role of an OEL regulatory framework in which numerical values are not properly understood, resulting in employer resistance to reducing exposure to as low as is technically feasible. Technological change is the primary driving force for improving the management of risks from chemical hazards. Substitution and specification standards operate alongside OELs in most countries we studied. At the same time concerns were raised about the misuse of OELs that result from faulty understanding of their meaning, which could include contributing a barrier to reducing exposure and countering demands for the application of good practice from regulatory inspectors. In Chapter 4 we noted that revision of the OEL framework in the UK led to the adoption of a single limit approach intended to combine good practice with special arrangements for carcinogens. Our investigations of practices in other countries would suggest that this is a step in the right direction and consistent with the approach desired by most of the regulators and stakeholders involved in our study. It would for example: -

encourage (or at least not discourage) the development of substitution strategies and the greater use of specification standards within a broader framework for chemical risk regulation

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not prevent inspectors from requiring improvements that were technically feasible help to reduce some of the misconceptions around the notion of a 'safe limit' allow the enforcement of good practice and avoid the necessity of sophisticated monitoring in some situations where it is neither economically feasible nor really necessary.

However, it is by no means certain that such reforms would alone be sufficient to address the problems of achieving widespread compliance with measures to assess and manage chemical risks. They will not solve the problems of risk perception and risk communication that seem to be inherent all the national systems for setting and using OELs that we have considered. While they may help improve the practice of risk management of hazardous chemicals amongst some duty-holders that currently fail to deal adequately with this subject, our analysis of wider European experience suggests there is no 'one size fits all* approach that can be applied successfully to this subject. Such reforms that are currently being canvassed are unlikely to reach all users, to particular, they will not guarantee that the practice of understanding and using OELs would be extended to substantially more duty-holders amongst owner managers in small enterprises, since their problems of compliance are considerably more wide ranging than can be addressed by this type of reform alone (Walters 2001). Neither do they address other concerns that we have raised, such as the question of access to services with the competence and resources to undertake monitoring or the extent to which the regulatory inspectorates are themselves sufficiently resourced and skilled to always deal adequately with OELs. We conclude therefore, that if substantial improvement is sought in the way in which all firms manage the risks of using hazardous chemicals, the kind of revision recently introduced in the UK needs to be part of a wider reform. It needs especially to address the issue of risk communication in rather more fundamental ways than at present. It requires integration within additional reforms to ensure the availability and use of professional preventive services that are sufficiently competent to undertake the monitoring of hazardous chemicals. Means to effect such availability and use would also have to take account of the particular challenges represented by small enterprises, which would additionally require special attention being paid to their education and information needs. Above all, the creation of an ethos of risk awareness for all involved in the use of hazardous chemicals is necessary. Some small steps can be made in this direction by clearer meanings for OELs included in the new OEL Framework.

364 Beyond Limits We have noted that best practice in Germany suggests that combinations of indicators of safe materials, plant and processes can be used to achieve greater worker protection from chemical risks without necessarily resorting to extensive monitoring. However, best practice in countries such as the Netherlands and in Sweden indicates that other measures to encourage participation, to make use of the skills and experience of trade union health and safety representatives and to engage with manufacturers and suppliers are also required. As the Dutch experience shows, substitution principles and specification standards steered by regulatory strategies can be arrived at by agreement between workers representatives, employers, manufacturers and suppliers, aided by the use of competent professional advice, if participants are empowered to make such agreements. OELs, far from being redundant in these processes have a variety of potential roles to play, ranging from the provision of information on hazardous substances, through design specification, to monitoring performance standards. These latter steps would seem to represent important ways forward. European Union strategic approaches to regulating chemical risk management look set to pay particular attention to supply chains in the future. They will place not only more stringent obligations concerning product stewardship on suppliers, but also will apparently require particular responses from users. The approaches described above at the level of the workplace appear to be in step with these regulatory developments, since they focus on ways of achieving improved risk management of hazardous chemicals across the full range of users, and imply more generic models of exposure assessment and control that are accessible and understandable to users with have neither the will or capacity to engage with more sophisticated exposure monitoring. The position of OELs will remain significant at international, national and sectoral levels as reference tools in the processes involved in setting specification standards OELs. Moreover, these developing trends also do not entirely preclude their role in workplace monitoring when it is required in special circumstances and they will remain useful to the specialists that are engaged in such work. Perhaps the most significant issue for the future is how to ensure that such approaches are implemented effectively. The attention that has been paid to the development of more comprehensive risk assessment of chemical substances, to models of exposure assessment and to control banding and to the role of OELs in all this is focussed on what are essentially supply issues. While it is important that their implications for the role of OELs are understood it is also imperative that at the same time a better understanding of the processes that might lead to greater user engagement is also achieved. Failure to do so risks the creation of a further elaborate system for regulating chemical supply that fails to focus sufficiently on the means to deliver effective

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outcomes at the level of workplace use and fails to address the known weaknesses of the existing system. While supply chains present some useful opportunities to increase leverage on both suppliers and users of products, it also needs to be recognised that the existence of modern supply chains and the extended business networks of which they are part are to a large extent aspects of trends in modern business practice in which organisations have sought to off-load transaction costs and reduce their responsibilities for the care of workers who would otherwise remain under their control. The rationale inherent in such chains is often concerned with the transfer of risk, which takes place against a background of unequal and exploitive contracting power. Added to this, modem supply chains are often the result of fragmentation of larger, previously whole systems and the export of work to less sophisticated systems of control, where workers interests are poorly represented. All of this means that such environments are less, rather than more, likely to be conducive to prioritising health and safety concerns as well as being less likely to engage in systematic health and safety management and they are further likely to present difficulties in monitoring actual performance in health and safety. Relying on such scenarios to improve health and safety outcomes in terms of chemical risk management without additional checks and balances also being in place does seem to be leaving rather a lot to chance. Therefore, while it is clear that product stewardship and user engagement are necessary elements in improving risk management of hazardous chemicals and that techniques embodied by modelling exposure assessment and control banding may be useful tools, the significant issue would seem to be how to achieve the appropriate levels of stewardship and user engagement in practice since it cannot be assumed that supply chains or the business rationalities behind them will automatically lend themselves to such outcomes. We think this implies further regulatory engagement of some kind. Current notions of 'smart regulation' embrace a wider range of regulatory strategies as well as those of inspection and enforcement that are traditionally associated with the work of regulatory agencies in health and safety. They include for example, encouraging corporate social responsibility and promoting the business case for health and safety through education and persuasion of employers; using partnership approaches, gaining agreements for joint actions between employers and trade unions and increasing links with worker representatives. But none of these strategies replace inspection or enforcement action, which, as the limited evidence that exists demonstrates, still remain powerful influences on employer behaviour. There is less evidence available concerning the effectiveness of the range of new approaches to

366 Beyond Limits 'smart regulation'. It seems most likely however, that none of these approaches are mutually exclusive and also what works in a particular sector or business relationship may not work so well in other settings. What therefore seems to be required to achieve improved risk management of chemical hazards is a combination of regulatory strategies and risk assessment and control tools that are appropriate to particular situations and that reflect calculations of their effectiveness. This in turn means that in the risk management of hazardous substances considerably more needs to be understood about what works, why it works and how much it costs to make it work in different supply chain scenarios and work environments than is currently the case. Developing such an understanding means more research and analysis of these scenarios is required. Currently much of what we know about the effectiveness of initiatives that target levers and influences in chemical supply chains to improve health and safety is descriptive rather than analytical and is often based more on opinion than on empirically grounded research. This means that emergent policies in this field are in great danger of being based on political and ideological notions rather than being in any true sense evidence based. There is also a danger that without proper understanding of the nature of different types of business networks and supply chains, the way they operate in different sectors and how they may be influenced, these emergent policies will not only be based on inadequate evidence of their success but will also be generalised to situations in which the supports necessary for their success are in any case absent. If future chemicals strategy is to be effective in engaging with both suppliers and users of chemical substances to improve the protection of workers then it is clear that such strategy must be based on a sound understanding of what supports and sustains successful prevention practice. While not unimportant, the nature and role of exposure limits in these situations is in many ways a secondary consideration to that of understanding the social and economic processes that influence risk perception, communication and management in the various scenarios that constitute the modern work situations in which chemical risks are experienced.

367

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376 Beyond Limits Topping. M. (2001). Occupational exposure limits for chemicals, Occupational and Environmental Medicine, Vol 58:138-144. Unger B. and van Waarden F. eds. (1995). Convergence or Divergence: Internationalisation and Economic Policy Response. Avebury: Aldershot. Visser, J. and Hemerijck, A. (1997J, A Dutch Miracle. Job Growth, Welfare Reform, and Corporatism in the Netherlands. Amsterdam University Press, Amsterdam. Vogel, L, (1998). Prevention at the Workplace: the impact of Community Directives on preventive systems in Sweden, Finland, Norway, Austria and Switzerland, European Trade Union Technical Bureau for Health and Safety, Brussels. Vogel, L. (1993), Prevention at the Workplace. An initial review of how the 1989 Community Framework Directive is being implemented. Brussels: European Trade Union Bureau for Health and Safety. Vogel, L. (1998). Prevention at the Workplace: the impact of Community Directives on preventive systems in Sweden, Finland, Norway, Austria and Switzerland, European Trade Union Technical Bureau for Health and Safety, Brussels. Vogel, L. (2001). Special report: Preventive services, TUTB Newsletter, No 21, ppl9 - 37. Walters, D. R. (2001). Health and Safety in Small Enterprises: European Strategies for Managing Improvement, Peter Lang, Brussels. Walters, D. R. (2001). Health and Safety in Small Enterprises: European Strategies for Managing Improvement, Peter Lang, Brussels. Walters, D, R. (2002). Working Safely in Small Enterprises in Europe, Brussels, ETUC. Walters, D. R. ed. (2002). Regulating Health and Safety Management in the European Union, PIE Peter Lang, Brussels. Walters, D. R. Grodzki, K. and Walters, S. L. (2003). The role of Occupational Exposure Limits in the health and safety systems of EU Member States, HSE Research Report 172, Sudbury: HSB Books. Walters, D.R. (2002). Regulating Health and Safety Management in the European Union, Brussels: PIE, Peter Lang. Walters, D.R. (ed.) (1996). The Identification and Assessment of Occupational Health and Safety Strategies in Europe, Dublin: European Foundation for the Improvement of Living and Working Conditions, vol. 1: The National Situations, 220p. WEA (2002). http:Avww.av.se/English/docs/systematic.shtm. WEA (2004). Plan of Activity 2004-2006, Stockholm: Work Environment Authority. Wilders, M. (2002). Risk-based TLVs for carcinogens: Do they add to worker protection? In: Proceedings of the INRS Expert Seminar "Hazardous Substances in the Workplace Minimising the Risks ", Paris 2002. Wilthagen, T. (1994), Reflexive rationality in the regulation of occupational health and safety, in R. Rogowski and T. Wilthagen, Reflexive Labour Law, Kluwer, Deventer.

References References

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Wiseman, J. and Gilbert, F. (2002). COSHH essentials: survey of firms purchasing this guidance, Contract Research Report 434, Sudbury: HSE Books Wiseman, J. and Gilbert, F. (2002). COSHH essentials: survey of firms purchasing this guidance, Contract Research Report 434, Sudbury: HSE Books. Work Environment Authority (2002). Chemicals Control at the Workplace - Limiting Chemical Hazards at Work, Stockholm: Work Environment Authority. Wriedt, H. (2003). The European trade union approach: threshold limit values as an instrument to reduce real life exposure of workers to carcinogens, paper presented at the National Conference on the Prevention of Risks of Cancer at the Workplace, Pisa, 20-22 February 2003. Wynne, B. (1994). Public understanding of science, in Jassanoff, S., Markle, G. E., and Pinch, T (eds.) Handbook of Science and Technology Studies, Sage London Wynne, B. (1996). May the sheep safely graze: a reflexive view of the expert-knowledge divide, in Risk, Environment and Modernity, eds. Lash, S, Szerszybski, B. and Wynne, B. Sage, London. Ziem, G.E. and Castleman, B.I (1988). Threshold Linit Values: Historical Perspectives and Current Practice, Journal of Occupational Medicine 31: 910 - 918.

This Page is Intentionally Left Blank

Annex I Websites of Ministries and other bodies involved in H&S4 Country

Name of the Institution / body etc. in the original language

Name of the Institution / body etc. in English (if provided)

Abbreviation

Internet address

Austria

Bundesministeriumfiir

Federal Ministry of Economics

BMWA

http://www.bmwa.gv.at/BMWA/defaulthtm (in German)

Wirtschaft & Arbeit

and Labour

http://www.bmwa.gv.at/EN/default.htm (in Englsih)

Sektlon III - Arbeitsrecht

Department III - Labour Law and

http://www.bmwa.gv.at/BMW A/Ministerium/Organigramm/sektion3 .htm

und Arbeitsinspektion

Labour Inspectorates

(in German); http://www.bmwa.gv.at/EN/Ministry/Organisational/

Zeniral Arbeitsinspektorat

Central Labour Inspection

hltp://www.bmwa.gv.at/BMWA/Themen/Arbeitsrecht'Arbeitsinspektion/

sektion3.htm (in English) defeulthtm (in German); http://www.bmwa.gv.at/EN/Topics/ Labourkw/Inspection/defaulthtm (in English)

Belgium

Le Service public federal

SPF

In order to reach the website of the SPF, you have to first to the following

Emploi, Travail et

website of the ministry of employment

Concertatwn sociale

http://www.meta.fgov.bepa/paa/framesetrriOO/.htm and you have to click on the link for "le SPF" on the left hand column.

Direction generate

If you have reached the SPF website via the procedure described above,

Controle du bien-Stre au

look under the first heading (Le Service public fidiral Emploi, Travail et

travail

Concertatian sociale par administration) for the link to the Direction generate Controle du bien-etre QU travail

Division du controle des risques chimiques

On the website of the Direction generate Controle du bien-etre au travail you either click on the link for the link for the Division du contrdle des risques chimiques provided for on that page at the beginning or you scrol to section 3.

379

If not indicated otherwise, the links are only available in the language of the country

Name of the Institution / body etc. in English (if provided)

Abbreviation

Inspection du travail

Internet address

You find the link to the labour inspection on the SPF website (see above) under the first heading (Le Service public federal Emploi, Travail et Concertation sociale par administration, last bullet point.

Denmark

Besfaeftigelsesministeriets

Ministry of Employment

BM

Arbejdstilsynet

Working Environment Authority

AT/WEA

http://www.at.dk/sw5441.asp (in Danish)

Arbejdsmilj0instituttet

National Institute of Occupational

AMI/NIOS

http://www.ami.dk/Om%20AMI.aspx?lang=da (in Danish)

http://www.bm.dk/Default.asp (in Danish) http://www.bm.dk/english/default.asp (in Englsih) http://www.at.dk/swl2158.asp (in English)

Health ArbejdsmiIj0rSdet

The Working Environment

http://www.ami.dk/Om%2QAMI.aspx?Iang=en (in English) AMR

http://www.amr.dk/

STM

http://www.5tin.fi/Resource.phx/stm/lndex.htx (in Finnish)

Council

Finland

Sosiaali-ja

Ministry of Social Affairs and

terveysministerid

Health

Tydsuojeluosasto

Occupational Safety and Health

TySsuojelupiirit

http://www.stm.fi/Resource.phx/eng/index.htx (in English) TSO

http://www.stm.fi/Resource.phx/vastt/tvosi/tsosa/index.htx (in Finnish)

Department

http://www.stm.fi/RESource.phx/eng/subjt/safet/oshdepart.htx (in English)

Occupational Safety and Health

http://www.doshnet.fi/hallinto/deiault.htni fon Finnish)

Inspectorates Kemian

Advisory Committee for

tyosuojeluneuvottelukunta

Occupational health and safety on

Tydterveysiaitos

Finnish Institute of Occupational

http://www.doshnet.fi/hallinKi/english/piirit/Default.htm (in English)

KETSU

http://www.ketsu.net/

TTL/FIOS

httD://www.ttl.fi/internetj'suomi (in Finnish)

Chemical

France

Health

http://www.occuphealth.fi/inteimet/english (in English)

Ministerede I'Emploi, du

Ministry for Employment,

http://www.travail.gouv.fr/ (in French)

Travail et de la Cohesion

Labour and Social Cohesion

http://www.fcavafl.gouv.ft/english/index.htm (in English)

sociale

00

o

I

Beyond Limits

Name of the Institution / body etc. in the original language

380

Country

Country

Name of the Institution / body etc. in the original language

Name of the Institution / body etc. in English (if provided)

Abbreviation

Internet address

Direction des relations du

Labour Relations Branch

DRT

http://www.travail.gouv.fr/ministere/drt.html

Social Security Directorate

DSS

http://lesservices.servicepublic.fr/mod_res/m_fserv.htm?DN=ou%3DC120

travail Direction de la s^curite

l%2C+ou%3DA01%2C+ou%3Dcentrale%2C+ou%3Dstractures%2C+ou

sociale

%3Draf%2C+o%3Dgouv%2C+c%3DFR&P PREC=national3 Le Conseil Superieur de

Higher Council for the

la Prevention des Risques

Prevention of Occupational Risks

CSPRP

This council does not have its own website

Professionnels Institut National de

National Institute of Research

Recherche et Sdcurite

and Security

L "inspection du travail

Labour Inspectorate

Caisse nattonale de

National Health Insurance Fund

I'Assurance Maladie des

for Salaried Employees

INRS

http://www.inrs.fr/ (in French) http://en.inrs.rr/ (in English) http://www,drtefp-paysdelaloire.travail.gouv.fr/§io.htro

CNAMTS

http://www.ameli.fr/134/RUB/134/orrib.html

ANACT

http://www.anact.fr/webstatic/

BMWA

http://www.bmwa.bund.de/ (in German)

travailleurs salaries

Germany

Agence nationalepour

National Agency for the

I'amelioration des

Improvement of Working

Wirtschaft und Arbeit

Labour

Bundesanstaltfir

Federal Institute for Occupational

Arbeitsschutz und

Safety and Health

http://www.bmwa.bund.de/Navigation/Service/english.html (in English) BAuA/FIOSH

http://www.baua.de/index.htm (in German) http://www.baua.de/eindex.htm (in English)

AGS

http://www.baua.de/prax/ags/index.htm

BQ

http://www.hvbg.de/d/pages/index.html (in German)

381

Conditions Ministry of Economics and

Annex I

conditions de travail Bundesministeriumftir

Arbeitsmedizin Ausschuss jur Gefahrstoffe Berufsgenossenschaften

Institutions for statutory accident

Name of the Institution / body etc. in English (if provided)

Abbreviation

insurance and prevention

Internet address

http://www.hvbg.de/e/pages/index.html (in English)

Gewerbeaufsickts&mter

http://www.ni-d.de/Doc/gewauf.html

Landesamterfitr

http://lasi.osha.de/

Arbeitsschutz Senatskommissiem zur

Senate Commission on the

htrp://www.drg.de/di^im_jHofiystruldin'/grermen/senat/korrmrissionen_au

Prtifung

Investigation of Health Hazards

sschuesse/senatskommission_pruefungL_arbeitsstoffe/index.html(in

gesundheitsschfidlicher

of Chemical Compounds in the

German); nttp://www.dfg.de/en/dfg_profile/structure('statutory_

Arbeitsstoffe

Work Area

bodies/senate/senate_cammissions_and_committees/investigation_health_ hazards/index.html (in English)

Greece

Ministry of Labour and Social

http://www.labor-ministry.gr/

Affairs Ministry of Health and Welfare

http://www.ypyp.gr/

General Directorate of Working

http://www.ash.gr/index_gr.html

Conditions and Health Centre of Occupational Health

K.A.Y.E

hni)^/www.ypergka.gr/main.php?u=^o2Fload.php%3Fd%3D9

EL.IN.Y.A.E:

http://www.elinyae.gr/ (in Greek)

and Safety Centre for Diagnosis of Occupational Diseases Elliniko Instttuyto xgieinis

Hellenic Institute for

kai asfaleias tis Ergasias

Occupational Health and Safety Joint State Technical Inspectors

Ireland

Minister for Enterprise,

http://www.elinyae.gr/ENGLISH/elinyae.htm (in English) SEPE http://www.entemp.ie/

Trade and Employment Health and Safety Authority (HSA)

http://www.hsa.ie/publisher/index.jsp

I

Beyond Limits

Name of the Institution / body etc in the original language

382

Country

Country

Name of the Institution / body etc. in the original language

Name of the Institution / body etc. in English (if provided)

Abbreviation

Health and Safety

Internet address

only reachable via the HSA website

Authority's inspectorate

Italy

Ministero della Salute

The Ministry of Health

http://www.mirdsterosalute.it/

Ministero del Lavoro e

Ministry of Labour and Social

http://www.welfare.gov.it/default

delle Politiche Social!

Affairs

Istituto Superioreper la

The National Institute of

Prevenzione e la

Occupational Safety and Health

ISPESL

http^/www.ispesl.it/

The National Institute of Health

ISS

http://www.iss.itf

CCTN

Sicurezza del Lavoro Istituto Superiors di Sanita Cotnmissione consultiva

The National Advisory

tossicologica nazionale

Committee on Toxicology

Institute Nazionale per

The National Institute of

L 'Assicurazione contra gli

Insurance against Accidents at

Infortuni sul Lavoro

Work

Istituto Italiano di

The Italian Institute of Social

Medicma Saciale

Medicine

Commissione consultiva

The Permanent Advisory Committee for Accidents

prevenzione degli

Prevention and Occupational

infortuni e I'igiene del

Hygiene

http://www.inail.it/

IIMS

http://www.iims.it/

lavoro Labour Inspectorate

Ministere du Travail et du

Ministry for Labour and

http://www.carabMeri.iti'cittadino/informa2iord/tutela/lavoro/lavoro_main. htm

Luxembourg

http://www.mt.etatlu/

383

Ispettorato del Lavoro

Annex I

permanente per la

MAIL

Abbreviation

Internet address

Name of the Institution / body etc. in the original language

Name of the Institution / body etc. in English (if provided)

/ 'Emploi

Employment

L 'Inspection du Travail et

Labour Inspectorate

ITM

http://www,itm.etatlu/#sec_au_travail

Ministirw da Seguranca

Ministry of the Social Security,

MSSFC

http://www.mssfc.gov.pt/index.php?eorpo=english (in English)

Social, da Familia e da

Family and Child ISHST

http://www.idict.gov.pt/

CES

http://www.ces.pt/ (in Portuguese)

Crianga Institute} para a Seguranca, Higiene e Saude no Trabalho Conselha Ecanamico e

Economic and Social Council

http://www.ces.pt/html/e_main.htm (in Englsih)

Social Comissao Permanamte

Permanent Commission of Social

de Concertacao Social

Consultation

Inspeccao Oeral do

http://www.ces,pt/html/e_main.htm IGT

http://www.igt .idict.gov.pt/

MTAS

http://www.mtas.es/

CNSST

http://www.cgt.es/spcgta/Comision.htm

INSHT

http://www.mtas.es/insht/index.htm

Trabalho

Spain

Ministerio de Trabajo y Asuntos Sociales Commission Nadonal de Seguridady Salud en el Trabajo Institute Nadonal de Seguridad e Hugienen el Trabajo

http://www.mtas.es/insht/sistemas/inspec.htm

Inspection de Trabajo

Sweden

Ndringsdepartementet

Ministry of Industry,

http://www.regeiingen.se/8b/d/1470 (in Swedish)

Beyond Limits

I

des Mines

Portugal

384

Country

Couutry

Name of the Institution / body etc. in the original language

Name of the Institution / body etc. in English (if provided)

Abbreviation

Internet address

http://www.sweden.gov.Se/sb/d/2067 (in English)

Employment and Communication ArbetsmiljSverket

Work Environment Authority

Arbetslivsinstltutet

National Institute for Working

http://www.arbetslivsinstitutet.se/ (in Swedish)

Life

http://www.arbetslivsinstitutet.se/en/ (in English)

Ministerie van Soclale

Ministry of Social Affairs and

http://home.szw.nl/index/dspjindex.cfm (in Dutch)

Taken en

Employment

http://www.employment.gov.nl/ (in English)

AV/SWEA

http://www.av.se/ (in Swedish) http://www.av.se/english/aboutjus/ (in Englsih)

The Netherlands

Werkgelegenheid Directoraat-Generaal

DGAVIB

http://almanak.overheid.nl/WPSServkt?action=document&id=49352

Arbeidsverhoudingen en Internationale Betrekkingen De Gezondheidsruad

The Health Council of the

http://www.gr.nl/index.php ?phpLang=nl (in Dutch)

Netherlands Dutch Expert Committee on

http://www.gr.nl/index.php (in English) DBCOS

http://www.gr.nl/wgd.php

SEE.

http://www.ser jil/ (in Dutch)

Occupational Standards Sociaal Economische

Social and Economic Council

Raad Subcommittee on MAC values of

waarden (MAC)

the Social and Economic Council

Health and Safety

HSC Advisory Committee on

Executive

Toxic substances

http://www.ser.nl/overdeser/de&ult.asp?desc=comnrissies_10_5#2 HSE/HSC/ACTS

http://www..hse.gov.uk/aboutus/hac/iacs/acts

Annex I

United Kingdom

http://www.ser.nl/deiault,asp?desc=en index (in Englsih)

Subcommissie MAC-

385

386

Annex II

1. 1. Basic Directives 474 Directives474

78/610 Vinyl Chloride Monomer (05.01.80) repealed by 99/38

A B

DK D E FIN F GR IRL

476 75 N C 47
C c Cc

C c NC

I L NL P p

Ss UK

C c Cc

C c

C c Cc

C c

98/24 80/1107 Chemical, physical & biological agents (05.12.85) repealed by 98/24

C c Cc

C c Cc Cc

C c Cc

C c

C NC C c

C c Cc NC NC

82/605 Metallic lead (01.01.86) repealed by 98/24 98/24

C c Cc

C c Cc Cc

C c Cc

C c

C c

C c Cc

C c Cc

C c

C c

98/24 88/364 banning of certain agents and activities (01.01.90) repealed by 98/24

C c Cc

C c Cc Cc

C c Cc

C c

C c

C c Cc

C c Cc

C c

C c

(31.12.92) 89/391 Framework (31.12.92)

C c Cc

C c Cc Cc

C c Cc

C c

C c

C c Cc

C c Cc

C c

C c

90/394 Carcinogens (31.12.92) repealed

C c Cc

C c Cc Cc

C c Cc

C c

C c

C c Cc

C c Cc

C c

C c

90/679 Biological agents (28.11.93) repealed

C c Cc

C c Cc Cc

C c Cc

C c

C c

C c Cc

C c Cc

C c

C c

91/155 Safety Data Sheets (30.05.91) (30.05.91)

C c Cc

C c Cc Cc

C c Cc

C c

C c

C c Cc

C c Cc

C c

C c

(05.05.01) 98/24 Chemical agents (05.05.01)

C c Cc

C c Cc Cc

C c Cc

C c

C c

C c Cc

C c Cc NC

C c

477 477

updated 10 10 August 1999 1999 Source: European Commission, DG Employment and Social Affairs last updated

18 December 2004 and CELEX on 18

The latest date foreseen in the Directives for the transposition into national legislation is given in brackets. Communication of national legislation. No reference available in CELEX for national implementing measures. http://europa.eu.in t/comm/employment_social/health_safety/status/status_en.htm.

I

Beyond Limits

Transposition of main European chemicals legislation (workers protection against hazardous chemicals)

oo ON

2. Amendments to basic Directives Directives Directives

A B

DK

D

E

FIN

F

GR

IRL

I

L

NL

p P

Ss

UK

83/477 Asbestos (01.01.87) / (01.01.90 (01.01.90mining) 83/477 – mining)

C C c

C c

C c

C

C c

C c

C

C c

C c

C c

C

C c

C c

C

88/642 Chemical, physical & biological agents (21.12.90) (21.12.90) 88/642

C C c

C c

C c

NC

C c

NC

C

C c

C c

C c

C c

NC

C c

C c

1st list of Indicative Limit Values (31.12.93) (31.12.93) 91/322 1st

C c Cc

C c

C c

NC

C c

NC

NC

C c

C c

C c

NC

NC

C c

C c

(01.01.96mining) – mining) 91/382 Asbestos (01.01.93) / (01.01.96

C c Cc

C c

C c

C

C c

C c

C

C c

C c

C c

C c

C c

C c

C c

93/88 Amendment of Biological agents (30.04.94) repealed

C c Cc

C c

NC

C c

C c

C c

C c

C c

C c

C c

C c

C c

C c

NC

93/112 Safety Safety Data Sheets (01.01.95) (01.01.95)

C c Cc

C c

NC

C c

C c

C c

C c

C c

C c

C c

NC

C c

C c

C c

95/30 Amendment of Biological agents (30.11.96) repealed

C c Cc

C c

C c

C c

C c

C c

C c

NC

C c

NC

C c

C c

C c

C c

nd 96/94 2nd list of Indicative Limit Values (01.06.98) (01.06.98)

C c Cc

C c

C c

NC

C c

NC

NC

C c

C c

C c

NC

NC

C c

C c

97/42 Amendment of carcinogens (27.06.00) repealed

C c Cc

C c

C c

C c

C c

C c

C c

C c

NC

C c

C c

C c

C c

C c

97/59 Amendment of Biological agents (31.03.98) repealed

C c Cc

NC

C c

C c

C c

C c

C c

NC

NC

NC

C c

C c

NC

NC

97/65 Amendment of biological agents (30.06.98) repealed

C c Cc

NC

C c

C c

C c

C c

C c

NC

NC

NC

NC

NC

NC

NC

1999/38 Amendment of carcinogens (29.04:03) repealed 1999/38

C c Cc

C c

C c

C c

C c

C c

C c

C c

NC

C c

NC

C c

C c

C c

2000/39 1st – 98/24 (31.12.01) 1st List of IOELV IOELV-98/24 (31.12.01)

C c Cc

C c

NC

C c

C c

NC

C c

NC

C c

C c

C c

C c

NC

C c

C c Cc

C c

NC

C c

C c

NC

C c

C c

C c

C c

C c

C c

NC

C c

478 478

consolidated 2000/54 Biological agents, consolidated

2001/58 Safety Safety Data Sheets Sheets (30.07.02) (30.07.02) (14.04.06) 2003/18 Asbestos (14.04.06) 479 2004/37 Carcinogens, consolidated consolidated479

Source: Source: European Commission, DG Employment and Social Social Affairs last updated 8 August 1999 1999480 and CELEX on 18 18 December 2004 2004

(seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 262 17.10.2000 p. 21). Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version) (Text with EEA relevance) (OJ L 158 30.04.2004 p. 50). http://europa.eu.int/comm/employment_social/health_safety/status/statusl_en.htm.

Annex II 387

Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work

388

Sources of legislative provisions and occupational exposure level lists

I

Country

Basic OSH Acts (general working conditions and latest OEL list hazardous chemicals)

Austria

Bundesgesetz iiber Sicherheit und Gesundheit bel der Arbeit (Arbeitnehmerlnnenschutzgesetz - AschG), Bundesgesetz-blatt fiir die Republik Osterreich, 17 June 1994 (BGB1. Nr. 450/1994, updated the last time in 1999 (BGB11 Nr. 70/1999) http://www.argerecht.at/APG/ArbeitnehmerInnensch utzgesetz.htm

Belgium

Grenzwerteverordnung 2003, Anhange I-III http://www.bmwa.gv.at/gkv/gkv.htm. You have to go to the end of the website where you find the MAK list in Annex I (Anhang I: Stqffliste), the TRK list in Annex II (Anhang II: TRK Liste), and the list of carcinogenic substances in Annex HI (Anhang III: Liste krebserzeugender Arbeitsstoffe)

Verordnung des BMWA uber Grenzwerte fur Arbeitsstoffe und Uber krebserzeugende Arbeitsstoffe (Grenzwerte-verardnung 2003 - GKV 2003) Bundesgesetzblatt jur die Republik Osterreich (BGBL II Nr. 253/2001 idF BGBL II Nr. 184/2003) http://www.bmwa.gv.at/gkv/gkv.htm Riglement general pour la protection du travail Arrite royal du 11 mars 2002 relattfa la protection de la sante et de (RGPT) la securiti des travailleurs contre les risques lies a des agents (dates from 1947481) chimiques sur le lieu de travail Code sur le bien-etre au travail Annexe I - Valeurs limites d'expositionprofessionnelle http.7/www.meta.fgov.be/pa/paa/fl"ameset&kf00.htm Annexe II - Valeurs limites biologiques contraignantes et mesures de Titre Vdu Code sur le bien-etre au travail la surveillance de la sante

Parts of the RGPT have been replaced since 1993 by the Code sur le bien etre au travail - Those parts of the RGPT which are still applicable can be found on the following website: http://www.meta.fgav,be'pa/paai'iramesetftkfflO.htai.

Beyond Limits

Annex III

http://meta.fgov.be/pa/frafr.htm?../pk/pkfi'pkfg/frkfgO O.htm&l Agents chimiques Arrete royal du 11 mars 2002 relatifa la protection de la sante et de la securite des travailleurs contre les risques lies a des agents chimiques sur le lieu de travail http://meta.fgav,be/pa/fraff.htm?../pk/pk£' pkfg/ frkfgOO.htm&l last amended by Arrete royal relatifa la surveillance de la sante des travailleurs http://www.staatsbladclip.be/lois/2003/06/16/loi2003012303.html

Agents biologiques Arrete royal du 4 aout 1996 eoncemant la protection des travailleurs contre les risques lies a Vexposition a des agents biologiques au travail

Arrete royal du 2 decembre 1993 eoncemant la protection des travailleurs contre les risques lies a Vexposition a des [agents cancerigenes et mutagenes (4)] au travail Annexe IListe de substances et preparations cancerigenes http://meta.fgov.be/pa/fraff.htm?../pk/pkfi'pkfg/frkfgOO.htm&l (you have to chose the second link provided on this website and then look for the annex) Arrete royal du 4 aout 1996 eoncemant la protection des travailleurs contre les risques lies a {'exposition a des agents biologiques au travail Annexe I-Liste des agents biologiques et lews classification http://meta.fgov.be/pa/fraff.htm?../pk/pk£7pkfg/frkfgOO.htrn&l (you have to chose the third link provided on this website and then look for the annex

Annex III 389

Agents cancerigenes, mutagens Arrete royal modiflant I'arrite royal du 2 decembre 1993 eoncemant la protection des travailleurs contre les risques lies a Vexposition a des agents cancerigenes et mutagenes au travail, et modiflant I'article 148decies, 1, § ler, du Reglement general pour la protection du travail http://meta.fgov.be/pa/frafr.htm7.ipk/pk0pkfg/frkfgO O.htm&l http://www.staatsbladclip.be/lois/2004/01/08/loi2003012724.html

http://meta.fgov.be/pa/frafF.htm?../pk/pkf?pkfg/frkfgOO.htm&l (you have to chose the first link provided on this website and then look for the annexes)

I

WEA Guide October 2002 - Limit Values for Substances and Materials http://www.arbejdstilsynet.dk/graphics/at/engelsk-pdf/atvejledninger/gvlisteuk.pdf

HTP - arvot 2002 http://www.ketsu.net/htp/2002.pdf (Finnish version) HTP-vSrden 2002 http://www.ketsu.net/htp/2002sve.pdf (Swedish version) no English version available on the internet

Beyond Limits

Finland

390

Denmark

http://meta.fgov.be/pa/fraff.htm?../pk/pkf/pkfg/frkfgO O.htm&l last amended by Arriti royal relatifa la surveillance de la santi des travailleurs http://www.staatsbladclip.be/lois/2003/06/16/loi2003012303.html Danish Working Environment Act 1975 (WEA) as last amended on 9 June 2004 http://www.at.dk/swl2403.asp Executive Order No. 292 of 26 April 2001 of the Danish Working Environment Service http://www.at.dk/swl2259.asp, last amended by Executive Order N. 496 of 27 May 2004 on Work with Substances and Materials (chemical agents) http://www.at.dk/swll631.asp - only available in Danish Executive Order No 906 on Measures to Protect Workers from the Risks related to Exposure to Carcinogenic Substances and Materials at Work, issued by the Danish Working Environment Authority on 8 November 2002 as subsequently amended http://www.at.dk/swl2255.asp Labour Protection Act - Tyoturvallisuuslaki http://www.occuphealth.fi/NR/rdonlyres/0C6B09EA -8FE6-4BF1-AAC552CE321A009B/0/Tyoturvallisuuslaki.pdf Occupational Health Care Act (Transposition of the EU Framwork Directive 89/391/EEC) http://www.fi.osha.eu.int/legislatioii/oshact.pdf

France

Valeurs limites d "exposition professionnelle aux agents chimiques en France - Cahiers de Notes Documentaires - Hygiene et Sicurite du Travail, 1999,174, ND 2098, pp. 59-77 http://www.inrs.rr/ You have to choose on the left column the link "dossiers", then from the menu Risque chimique (under the 3 rd headline Types des risques), here you chose the 9* dossier {Introduction aux valeurs limites d'exposition professionnelle), go to the bottom of this document and click on the first link provided in the last box.. There you click on the pdf link in the box titled Telecharger le texte integral de ce document.

Annex III 391

Ordinance No. 715 of 9 August 2001 of the Council of State concerning chemical agents at work Valtioneuvoston asetus kemiallisista tekijoista tySssa (Transposition of the BU Chemical Agents Directive 98/24/EQ http://www.fMex.fi/fi/laki/alkup/2001/20010715 Decision No. 1232 of 2000 of the Ministry of Social and Health Care to amend the Decision of the Ministry of Labour on carcinogenic substances (No. 838 of 1993) - Asetus sySpasairauden vaaraa aiheuttavista tekijoista annetun tyoministerion paatoksen 1 §:n ja liitteen muuttamisesta (Transposition of the EU Carcinogen Directives) http://www.finlex.fi/Maki/kokoeteia/2000/2000017 4.pdf Code du travail http://www.adminet.com/jo/code travaiLhtml Decret n° 2003-1254 du 23 decembre 2003 relatifa la prevention du risque chimique et modifiant le code du travail (deuxieme partie : Dicrets en Conseil d'Etat) (transposition of the EU Chemical Agents Directive 98/24/EC) http://www.adminet.com/jo/20031228/SOCT031162 2D.html Decret n°2001-97 du lerfevrier 2001 etablissant les regies particulieres de prevention des risques cancirogenes, mutagenes ou toxiques pour la reproduction et modifiant le Code du travail (transposition of the EU Carcinogen Directives)

Ireland

MAK & TRK values: Technical Rule (TRGS) 900 http://www.baua.de/prax/ags/trgs900.pdf BAT values: Technical Rule (TRGS) 903 http://www.baua.de/prax/ags/trgs903.pdf TRGS 905 (Inventory of CMR substances) http://www.baua.de/prax/ags/trgs905 .pdf

P.D.90/99 transcribed 91/322 EEC and 96/94 EC Directives on establishing a first and a second list of indicative limit values P.D.339/2001 was issued in accordance with the 2000/39 EC Directive. http://www.osh.gr/workcond http://www.osh.gr/Kyae http://elinyae.gr

Code of Practice for Safety, Health and Welfare at Work (Chemical Agents) Regulations, 1994. Dublin.

I

Beyond Limits

Greece

http://admi.net/jo/20010203/MEST0110001D.htail Gesetz fiber die Durchflihrung von Mafinahmen des Arbeitsschutzes zur Verbesserung der Sicherheit und des Gesundheitsschutzes der Beschaftigten bei der Arbeit (Arbeitsschutzrahmengesetz) http://bundesrecht.juris.de/binidesrecht/arbschg/index .html Chemicals Act - Chemikaliengesetz http://bundesrecht.juris.de/bundesrecht/chemg/ (last amended 2004) Dangerous Substances Regulation / Ordinance Gefahrstoffverordnung http://bundesreeht.juris.de/bundesrecht/gefstoffv_199 3/ (last amended 2004) Act 1568/85 on Health and Safety at Work Presidential Decree 17/1996 Act 1568/85(Chapter V, Article 24, Definitions) P.D.307/86 P.D.77/93 P.D. 77/1993 P.D.338/2001 transcribed almost verbatim the Directive 98/94/EC "on the protection of the health and safety from the risks related to chemical agents at work (14th individual Directive) risks related to carcinogenic agents at work P.D.399/94 and P.D. 127/2000 have adopted 2004/37/EC and 97/42/EC Directives. Safety, Health and Welfare at Work (General Applications) (Amendment No. 2) Regulation, 2003,

392

Germany

Italy

1st and T^ modification of the Carcinogen Directive

Annex III 393

S.I. No. 053 http://www.niso.ie/documents/COPChemAgents.pdf http://www.hsa.ie/files/file_20040618124510sl53 2 003.pdf Safety, Health and Welfare at Work (Chemical Agents) Regulations, 2001, SI No. 619 http://www.hsa.ie/files/file_20040618124510si619_2 OOl.pdf Safety, Health and Welfare at Work (Biological Agents) (Amendment), Regulations, 1998, S.I. No. 248 http://www.hsa.ie/files/file_20040618010414si248 1 998.pdf Safety, Health and Welfare at Work (Carcinogens) Regulations, 2001, S.I. No. 078 http://www.hsa.ie/files/file 20040618125656si78 20 Ol.pdf Decreto Legislative} n. 626 del 19/09/1994 transposition of Directive 89/391/EEC and 2004/37EC (amongst others) http://www.di-elle.it/Leggi/l 994-626.htm Decreto Legislative) 25 febbraio 2000, n 66 — transposition of Directive 97/42/EC and 1999/38/BC482 http://www.camera.it/parlam/leggi/deleghe/testi/0006 6dl.htm Legge 29 dicembre 2000, n. 422 - delegates to the Government the right to issue the decrees for the

394

Reglement grand-ducal du 10/07/1995 relatifa la fixation de valeurs limites concernant la protection des travailleurs contre les risques lies aune exposition a des agents chimiques pendant le travail http://www,itm,etat.ly/legisnat/cd_94_95/0710a/071Oa.pdf Reglement grand-ducal du 28 fevrier 1999 modifiant le reglement gran-ducal du 10 juillet 1995 relaiifa la fixation des valeurs limites concernant la protection des travailleurs contre les risque lies a une exposition a des agents chimiques pendant le travail http://www.ilrn.elaUu/1egisriat/cd_99/0228/0228.pdf Reglemeni grand-ducal 15 juillet 1988 concernant la protection des travailleurs contre les risques lies a une exposition au plomb metallique et a ses composes ioniques pendant le travail. http://www.legi lux .public.! u/1eg'a/archives/198 8/0403 007/040 3 00 7.p df

Beyond Limits

implementation of 27 EU Directives within one year, amongst others for Directive 98/24/EC http: //www. ambiente. it/sicurezza/legislazionc/leggi/2 000/legge29-12-2000.htm Luxembourg Loi du 17 juin 1994 concernant la securite et la sante des travailleurs au travail http://www.ctat.lu/MS/MED_TRAV/Memorial3.pdf Reglement grand-ducal modifie du 4 novemhre 1994 concernant la protection des travailleurs contre lex risques lies a I'exposition a des agents cancerigenes au travail. http://www.itm.etat.lu/legisnat/cd 94 95/1104f/1104 f.pdf Reglement grand-ducal du modifie 4 novembre 1994 concernant la protection des travailleurs contre les risques lies a I'exposition a des agents biologiques au travail http://www.ittn.etat.lu/legisnat/cd 94 95/1104g/l 10 4g.pdf Loi du 19 juillet 1991 modifiant la loi du 20 mat 1988 concernant la protection des travailleurs contre les risques lies a /'exposition a des agents chimiques, physiques et biologiques pendant le travail http ://www.itm.etat.lu/legisnat/cd 91 /0719/0719.PD F

3

Portugal

Spain

Published as a standard (Norma Portuguesa 1796 from 1988)483 by the Portuguese Institute for Quality (Instituto Portugues da Qualidade - IPQ)m - not online available

Limites de Exposition Profesional para Agentes Quimicos (2004) published by the Instituto National de Seguridad e Hugiene (INSHT) http://www.mtas.es/insht/en/practice/vlasen.htm

NP 1796:1988 (2" Edicao) pp.41 C 420ICT 42 Higiene e seguranja no trabalho. Valores limites de exposicao para substSncias nocivas existentes no ar dos locais de trabalho del Instituto Portagufe da Qualidade (IPQ) Http:/Avww.ipq.pt/

Annex III 395

Decreto-Lei n° 441/91 and n" 26/94 Diario da Republica 262/91, Serie IA de 14/11/1991 and Diario da Republica 26/94, Serie I-A de 01/02/1994 http://www.diramb.gov.pt/data/basedoc/TXT_LN_53 04_2_0001.htm Decreto-Lei n"290/2001 Diario da Republica 266/01, Serie I-A de 16/11/2001 http://www.dgert.msst.gov.pt/legislacao_seguranca/d 1290 01.htm Ley 31/1995 de Prevention de Riesgos Laborales http://noticias.juridicas.com/basedatos/Laboral/1311995.html Real Decreto 374/2001, de 6 de abril sobre la protection de la salud y seguridad de las trabqjadores contra los riesgos relacionados con los agentes quimicos durante el trabajo http://www.garben.com/pg2001/legislacion/legl5.ht m Real Decreto 349/2003, de 21 de marzo de 2003 (B.O.E.: 5-4-2003, N° 82) Modifica el Real Decreto 655/1997, de 12 de mayo, sobre protection de los trabajadores contra los riesgos relacionados con la exposition a agentes cancerigenos durante el trabajo, y por el que se amplia su ambito de aplicacion a los agentes mutdgenos

United Kingdom

Health and Safety at Work etc. Act 1974 Control of Substances Hazardous to Health Regulations 2004, SI 2004 No.2677 Chemicals (Hazard Information and Packaging for Supply) Regulations 1994, SI 2002, No.l6S9

Staatsblad 1997, N° 63 / Http://nLosha.eu.inVcontent/networ^ ht^://nl.osha.eu.int/content^ietwork/szw/docs/grenswaaatien.p(^1. http://www.bbzfav.nJ/OTbobwi.htm. http://www.fhv.nl/702werkgeld/arbo

EH40/2005 Workplace exposure limits: Containing the list of workplace exposue limits for use with the Control of Substances Hazardous to health Regulations 2002 (as amended), Environmental Hygiene Guidance Note EH 40, HSE Books 2005.

Beyond Limits

The Netherlands

http://www.mtas.es/Guia2004/leyes/RD34903.htm Statute Book of the Swedish National Board of Occupational Safety Work Environment Act http://www.sweden.gov.Se/content/l/c6/01/99/26/74 and Health, AFS 2000:3, Occupational exposure limit values and measures against air contaminants 03b8a3.pdf Statute Book of the Swedish National Board of http://www.av.se/english/legislation/afs/eng0003.pdf Occupational Safety and Health, AFS 2000: 4, Chemical Hazards in the working environment http://www.av.se/english/legislation/afs/eng0004.pdf Working Environment Act Bijlage VI behorend bij artikel 4.19 eerste lid, Lijst van wettelijke Arbeidsomstandighedenwet - Arbowet, grenswaarden op grond van artikel 4.9 van het http://www.xs4all.ru/~wilcodeb/arbol998.html Arbeidsomstandighedenbesluit486 Arbeidsomstandighedenbesluit Bijlage VII behorend bij artikel 4.20, eerste lid, Lijst van wettelijke http://wetten.overheid.nl/cgigrenswaarden voor kankerverwekkende stoffen op grond van artikel bin/deeplink/lawl/title=ARBEIDSOMSTANDIGHE 4.16 van het Arbeidsomstandighedenbesluit437 DENBESLUIT Bijlage 6 behorend bij beleidsregel 4.2 -1 Arbobesluii488 Arbeidsomstandlghedenregeling 1997 - Arboregeling 1997.48S

396

Sweden

3

Control of Asbestos at Work Regulations 2002, SI 2002 No.2675 Control of Lead at Work Regulations, SI 2002, No.2676 Control of Major Accident Hazard Regulations 1999, SI1999NO.743 Dangerous Substances and Explosive Atmospheres Regulations 2002, SI 2002 No.2776 Ionizing Radiations Regulations 1999, SI 1999, 3232

Annex III 397

Country Austria

Denmark

Body / Institution Arbeitnehmerschutzbeimt 1 Advisory Committee for Workers Protection489

Description Composed of representatives of the social partners, labour inspectors, the responsible ministry and other ministries affected by the issues discussed, and the Insurance Association for Occupational Accidents.

It meets regularly and is chaired by the head of the Central Labour Inspectorate. Its main task is to act as an advisory committee for the Ministry on basic questions of health and safety at work, including the review of the existing OEL list. It also considers drafts of proposed laws and regulations. It has the power to establish specialised working groups, one of which is the expert group for OELs, which develops the recommendations for occupational exposure limit values. Members of the expert Committee are nominated by the various interest groups (amongst which are the employers and the trade union confederations) according to the statute of the Arbeitnekmerschutzbeirat. In addition, the Committee can consult additional experts including scientists in the field of occupational health and safety, occupational hygienists, epidemiologists, experts representing the social partners, occupational physicians etc. Danish Working Environment Consists of representatives of employers' and employees' organisations. Council's Committee on Limit Values The Revision Committee for Limit A committee set up by the Working Environment Council. The Committee is composed of three representatives from each party involved in the procedure, as well as a representative Values from the management. The task of the Committee is to process technical and financial objections, and to balance these against the basis for the health evidence. To assist in

Information was provided by the Austrian SCOEL member.

Beyond Limits

National institutions responsible for setting occupational exposure limits

398

Annex IV

CO

v: 2

i

Country

Finland

Body / Institution

Description processing technical/financial objections the Committee has several ad hoc committees attached to it. The Revision Committee for Limit Values notifies the results of its work to the Working Environment Council. The Scientific Quality Committee A committee set up by the Director General of the Working Environment Authority, comprising experts from within the field with no connection to the Working Environment Authority or the Social Partners. The Committee is chaired by the Working Environment Council and the secretarial function is filled by the Working Environment Authority. The tasks of the Committee are to ensure uniformity and consistence in the health evidence for limit values, and to process objections to this evidence. The results if the Committee's determinations are open to the public. Advisory Committee on A multipartite Advisory Committee to the Ministry of Social Affairs and Health.490 It is a Chemicals, co-operative body appointed by the Council of State (Government) upon the submission of the Ministry of Social Affairs and Health for a term of three years. Its members represent the relevant authorities responsible for chemical control and the most representative organisations of trade, industry, and employees. It is composed of representatives of the following agencies: -

http://www.vn.

fi/stin/engHsh/orgaii/organisation_fset.htni

Annex IV 399

-

the Ministries of Social Affairs and Health, of the Environment, of Trade and Industry and of the Interior National Product Control Agency for Welfare and Health Finnish Environment Institute Safety Technology Authority Federation of Finnish Commerce and Trade Chemical Industry Federation Chemical Workers' Union.

Body / Institution

The Advisory Committee contributes to: - reforming the legislation on chemicals — preparation of EU affairs concerning chemicals - implementation of the Chemicals Programme of the OECD — monitoring and informing about the actions of the Chemicals Group of the Nordic Council of Ministers — issuing guidelines for the handling and storage of dangerous chemicals. Finnish Institute of Occupational FIOH is a public corporation supervised by the Ministry of Social Affairs and Health. It is Health (FIOH) a research and advisory institute whose main tasks are research, training of occupational health and safety professionals, provision of advisory services, and dissemination of information.

France

Its research is concentrated on workers' health (including the working environment/physical and mental pressure of work/risks arising from chemical substances, noise, heat and radiation/safe working methods/occupational accidents and illnesses). Experts of FIOH give instructions on the planning of the working environment. The services include measuring harmful radiation doses at workplaces, testing people applying for demanding professions, psychological studies concerning work, development of workplaces and directions on the establishment of action programmes concerning occupational safety and health. FIOH organises about 300 training courses for OHS professionals on various topics related to occupational safety and health. FIOH also acts as an information centre on OHS. Conseil superiew de la prevention The Council was established in 1976 and is the main consultancy body for the Ministry

8

I

Beyond Limits

Description The Advisory Committee has called in permanent experts from the Finnish Institute of Occupational Health (see below), the National Public Health Institute, the Environment Centre of the City of Helsinki and the Finnish Association of Nature Conservation.

400

Country

Country

Body / Institution desrisquesprofessionnelles

Description with respect to H&S issues. The Council is consulted on all questions and for all legislative projects in relation to health and safety at work or with respect to the quality of the working environment. It formulates proposals for improving the working conditions, conducts investigations and establishes priorities for action programmes at national level. The Council is a quadripartite body with representatives of: - The organisations of the Social Partners'*91 - Other ministries affected by H&S issues (agriculture, health, industry, environment etc.) - Specialised institutes and organisations like MRS, CNAM, ANACT492, OPPBTP - Qualified experts (scientists, occupational hygienists and technicians, occupational physicians).

Germany

The Social Partners are not only involved in the committees and working groups of the Council, they also part of the administration of the branch of the Commission on occupational accidents / occupational diseases, and they are part of the administrative council of INRS. AgenceNatianaie pour I'Amelioration des Conditions de Travail—National Agency for the Improvement of Working Conditions.

Annex IV 401

Groupe scientifique pour la surveillance des atmospheres de travail 1 Scientific Group for the Surveillance of the Working Atmosphere/Environment Ausschufi jur Gefahrstoffe 1 Committee on Hazardous

The work of the Council is undertaken within the framework of either specialised committees or technical working groups. It meets once a year in a plenary session, chaired by the Minister, during which it reviews action in progress and adopts the priority orientations for the forthcoming year(s). This expert group is attached to the Higher Council for the Prevention of Occupational Risks. This group includes prevention experts and experts on chemical risks, representatives of the regional health insurance companies, occupational physicians, toxicologists, people from industry, and MRS. The Committee is an Advisory Committee to the responsible Federal Ministry.

Description The Committee meets twice a year in order to adopt OELs. The Committee is a statutory body (§52 Dangerous Substances Regulation GefahrstoffVerordnung.

-

Beyond Limits

Body / Institution Substances

402

Country

3

MAK Kommission Commission

1

It has 40 members, which belong to various interest groups, including representatives of: — the Social Partners - the Federal and Lander authorities - producers and manufacturers of hazardous substances — the institutions for statutory accident insurance and prevention (Berufsgenossenschqften) and — the MAK Commission. It has several sub-committees and working groups (some permanent, some established for specific tasks). The various interest groups are also represented within these subcommittees and working groups. MAC The Senate Commission on the Investigation of Health Hazards of Chemical Compounds in the Work Area (The MAK Commission) is a scientific expert group of the German Science Foundation (Deutsche Forschungsgemeinschaft - DFG). The Commission is responsible for determining the current state of research relating to the health risks posed by substances and materials used at the workplace and for advising the German Federal Ministry of Economics and Labour so as to provide it with a basis for reaching objective decisions. To do this, the commission studies substances used at the workplace, i.e. chemicals, dust or compounds, such as cooling lubricants or their components, for their toxicological and medical relevance. The results of this evaluation serve as a basis for setting Maximum Workplace Concentrations (Maximale Arbeitsplatzkonzentrationen - MAK) and Biological Tolerance Values for Occupational Exposures at the Workplace (Biologische Arbeitsstqfftaleranzwerte - BAT) or for

Country

Greece Ireland Italy493

Description classifying substances as carcinogens. These values are published annually in a scientific report.

Dangerous Substances Advisory Committee (DSAC) The National Institute of Occupational Safety and Health (Istituto Superiore per la Prevenzione e la Sicurezza del iawro-ISPESL)

A forum which provides both external expertise in relation to the establishment of OELs and a mechanism for consultation with the social partners. The Institute is one of the technical-scientific bodies of the National Health Service under the Ministry of Health and it operates on all occupational safety and health matters. As well as the National Advisory Committee on Toxicology (see below), the task of proposing exposure limits is addressed by ISPESL, which relies on recommendations by the ILO or EC directives that address occupational exposure to carcinogens and other hazardous chemicals in the workplace. The National Institute of Health is another technical-scientific organ of the National Health Service. It enjoys scientific, organisational, administrative and accounting independence and is subject to monitoring by the Ministry of Health. It undertakes research, experimental, control and training functions in relation to public health. Provides information on chemical compounds and their effects on health. The general aim is to draw up guidelines and perform toxicological evaluations of chemicals, mainly for carcinogenicity, teratogenicity and mutagenicity. It is done through an evaluation of the scientific evidence available in literature, and other sources, including confidential ones. The intended users are the health personnel of the National Health Service and epidemiological researchers. Reports on single chemicals or groups are distributed on request and free of charge. Operates under the authority of the Ministry of Labour, managing the mandatory insurance funds for occupational accidents and diseases. INAIL has regional and local offices all over the country.

The National Institute of Health (Istituto Superiore di Sanita - ISS)

The National Advisory Committee on Toxicology (Commissione consultiva tossicologica nazionale)

The National Institute of Insurance against Accidents at Work {Institute Nazionale per

Information on most of the bodies described in the following can be found on the following web pages: Http://www.ispesl.it/; Http://www.iss.it/; Http://www.inail.i1/; http://www.iims.it/.

Annex IV 403

Body / Institution

Description

Advisory body, under the Ministry of Labour, studies social diseases and prevention.

I

The committee is chaired by the Minister of Labour, it monitors application of legislation, as well as its updating, and is composed of a great number of members regarding all aspects of OHS. The most represented bodies are the: Ministry of Labour, Ministry of Health, ISPESL, Regions and Autonomous Provinces, Trade Unions, Employers' Organisations. In addition, the following institutions are represented by one member: Ministry of Industry and Trade, Ministry of the Interior, Ministry of Defence, Ministry of Transport, Ministry of Agriculture, Ministry of Environment, Office of the Prime Minister, MAIL, ITMS, National Institute of Health (ISS), National Fire Brigade, National Research Council (CNR), National Body of Standardisation (UNI), Italian Electrotechnical Committee (CEI), National Environment Protection Agency (ANPA).

Conselho Econornico e Social 1 Created in the 1989 revision of the Portuguese Constitution, the Council is a consultative Economic and Social Council body of diversified composition, described by the Constitution as a body for "consultation and concertation in the field of economic and social policies" Its 63 members include representatives of government, trade unions, employers' associations, the liberal professions, the Autonomous Regions and local authorities, environmental protection organisations, consumers' associations, family associations, and universities. Comissao Permananete de A tripartite body with 6 representatives of the trade unions (3 from each of the 2 Concertagao Social I Permanent confederations), 6 representatives of employers' organisations (2 from each of the 3 Commission of Social confederations) and representatives of the Ministry. Consultation http://www.ce$.pt/html/e ma.in.htm

Beyond Limits

Luxembourg Portugal

Body / Institution L 'Assicurazione contro gli Infortuni sul Lavoro -MAIL) The Italian Institute of Social Medicine (Istituto Italiano di Medicina Sociale-TMS) The Permanent Advisory Committee for Accidents Prevention and Occupational Hygiene {Commissione consultiva permanente per la prevenzione degli infortuni e I'igiene del lavoro)

404

Country

Country Spain

Description Advises the Public Administrations on the formulation of preventive policies and acts as an institutional participatory body on issues relating to health and safety at work. It is made up of the state government administration, the Autonomous Region government administrations and the most representative trade union and business organisations, which constitute its four representative groups. In order to carry out its duties, it meets in Plenary, Permanent Committee and Workgroup sessions, in accordance with the stipulations of its Internal Operating Rules. Agreements are adopted by majority, with each representative of the public administrations (from the central and the regional governments) having one vote and those from the business and trade union organisations having two. Institute) Nacional de Seguridad e A specialised scientific/technical body of the Ministry, whose mission is the analysis and study of occupational health and safety conditions, as well as the promotion of, and support Higiene en el Trabajo494 for, improvements to them. To this end, it has established the necessary lines of cooperation with the competent bodies of the Regional Governments. To fulfil its mission, FNSHT carries out various functions, including: - Technical assistance - Study/Research - Training - Promotion/Information/Dissemination - Development of guidelines/Standardisation - Testing/Certification of protective equipment and machinery - Technical co-operation - Secretariat of the National Commission for Health and Safety at Work.

Sweden

Criteria Group within the National Consists of scientists in relevant fields and experts from the trasdes unions and employers* Institute for Working Life organisations. Dutch Expert Committee on Occupational Standards - DECOS.495, the Sub-Committee on

Http://www,mtas. es/inskt/en/mdex_en. htm

Annex IV 405

The

Body / Institution Comision Nacional de Seguridady Salud en el Trabajo 1 National Commission of Security and Health at Work

http://www.gr.n]/overi^standing%20committees/DECXIS.htm. http://www.gr.nyOVERIG/PDF/[email protected].

Beyond Limits

Description MAC values of the Social and Economic Council - SER).496 The Advisory Committee on ACTS is one of the tripartite advisory committees established to advise the Health and Toxic Substances Safety Coimmission. It is composed of representatives or expert nominees of employers, workers, and the state along with some independent members. Its sub committee, the Working Group for the Assessment of Toxic Chemicals (WATCH), which is again represntative of tripartite interests, is responsible for making recommendations to ACTS on setting new OELs as well as reviewing existing ones. HSE specialists in its Chemicals Directorate support the process. Body / Institution

406

Country Netherlands United Kingdom

CO

v: 2 a.

407

INDEX A Accident Insurance Law, 178 Accident Prevention Regulations, 188 ACGIH, 5,6,7,21,22,23,24,25,26,76,77, 80, 81,85, 86,88, 89,112,115,116,127, 162,234,235,237,270,284, 285, 293, 294, 295,324,368,369 Acops, 122 ACSHH, 56 ACTS, 1,23,71,93,128,129,132,146,147, 157, 385,406 ACTS/WATCH, 23 Administrative Sanctions, 103,108,232,233, 237 Advisory Committee For Occupational Health And Safety On Chemicals, 68, 86 Advisory Committee On Toxic Substances. See ACTS, See ACTS, See ACTS, See ACTS, See ACTS AGW.79,183,184,186 Airborne Chemicals, 2,304 Airborne Contamination, 4,221 ALARP, 157 ALATA, 273,274 Allergies, 18 American Conference Of Governmental Industrial Hygienists. See ACGIH, See ACGIH, See ACGIH Annals Of Occupational Hygiene, 128,147, 151, 367,368, 370, 371, 372, 373, 374, 375 Approved Codes Of Practice, 122 Arbeitsplatzrichtwerte, 23 Arbodienst, 110,298, 299, 354 Aas Low As Is Reasonably Practicable, 82, 157, 347 Asbestos, 6, 15, 24,46, 73, 74, 78, 100, 105, 125, 133, 174,184, 234,240,262,266,270, 273,276,283,307,326,346 Austria, Ii, 2, 68, 72, 76, 84, 94,113, 376, 379, 388, 398 Authorisation, 12, 57,59

B Ban With Exemptions, 46 Banding, 148,347,350,351,364,365 Barriers To Trade, 41,46 BAT Values, 87,186,187,188,208, 392 BAT-List, 79 Bblvs, 54,80 Behavioural Controls, 4 Belgium, Ii, 2, 68, 76, 85, 95,379, 388 Benzene, 6,31,52,78,100,207,234,247, 273 Berufsgenossenschafen, 174 Best Practice, 20,154,201,282,286,364 BGHolz, 194,197,202,204 Bgen, 18,176,178,192,209,213,221,224, 344 Biological Agents, 24, 38,39,47,48,49, 52, 53,54,72,73,124,191,230,267,386,387 Biological Effects, 19 BOELVs British Occupational Hygiene Society, 167

C Cancer, 15,17,18, 82,156,157,158,174, 200,245,294,317,369,370 Capital, 4, 123,258 Carcinogenic, 31,43,46,58,73,81,182,191, 235,293,296,311,326,388,390,392 Carcinogens, 6, 14,17, 24,39,44,47,48, 50, 51,52, 76,77, 80,81,82,116,150,157, 184, 185, 186, 193,194,201,262,267,270, 271,293,294,295,306,324, 362,369,376, 377,387,402,403 Carcinogens Directive, 49, 50 Casualisation, 8 CEFIC, 2,13,17,368 Cement, 143, 144,245 Central Nervous System, 18,205,208 Centre Of Health And Safety At Work (JCYAE), 103,231 CGIL, 274

408 Beyond Limits CHAN, 93,132 Chemical Carcinogens, 17 Chemical Hazard Alert Notice, 93,132 Chemical Health And Safety, 1,10 Chemical Industry, 4,13,14,15,17,18,23, 86, 119,135,173,209, 259,261, 284,289, 309, 320 Chemical Legislation European Enforcement Network, 43 Chemical Polluters, 3 Chemical Production, 14,320 Chemical Safety Assessment, 34 Chemical Safety Reports (CSR), 34 Chemicals Industry, 14,17,135,351 Chemicals Policy, 13 CHIP, 126,136,148,149 CISL, 274 Cleaning Agents, 43, 215 CLEEN, 43 CMR, 43,78,187,392 Cmrs, 58,59,78, 79 CNAM,78, 101, 113, 114,400 CNAMTS, 87, 381 Communication, 6,8,19,28,35,60,61,62, 337, 351, 363, 366 Communication, 386 Compliance, 10,12,43, 66,94, 96, 97,98, 99, 100,107, 109,110, 112, 113,114, 116,117, 127,128,129,139,143,150,157,159,160, 161,162,163,169,176,177,184,188,189, 190,200,205,217, 218,220,222,223,236, 239,243,245,247,248,251,253,260,262, 263,274,276,279,280,281,283,284,285, 286,290, 300, 303, 306, 308,311,312, 314, 317,320,323, 325,327,329,330,333,336, 338,341,342,343,346,347,348,352,353, 358, 363,370 Conservative Government, 142 Consumer Safety, 3 Contractor Labour, 8 Contractors, 8 Control Limits, 127,128,133 Controlling, 3,4, 5,17,28, 31, 39, 57, 122, 130,136,145,148,155,161,203,230,264, 276,305,316,317,350 Convmanten, 290, 301, 310, 311, 312,314, 315,317,318

Corporate Bias, 7,26 Corporate Information, 26 Corporatist, 296,297,315,319,320 COSHH, Ii,6,19,24, 111, 112,123,124,125, 126,127,128,129,132,133,134,135,136, 138,139,140,141, 142,143,144, 145, 147, 148,151, 152,153,155,156,157,159,160, 162,164,165,167,168,252,349,358,361, 367, 368, 371, 374, 375, 377 COSHH Regulations, 6, 111, 123,125, 127, 128,129, 132,134,135,136,138,139,140, 145,151, 155,157,159,162 Council Directive 67/548/EEC, 32,39,42 Council Regulation 793/93,32 CRAM, 101,113,114 Criteria Group, 71,90,324,325,405 CSR, 34 D Dangerous Preparations Directive, 42 Dangerous Substances Advisory Committee, 88,403

Dangerous Substances Directive, 40,126 Danish Working Environment Authority, 85, 96,390 DECOS, 71, 77, 85, 86,292,293,294, 295, 296, 385,405,406 Denmark, E, 2,68,77, 85,96,166,296,309, 325,335,355,380,390,398 Detergents, 43 Directive 1999/45/EC. 39,40,41,42 Directive 67/548/EEC, 39,40,46,78,81,182, 206,294 Directive 76/769/EEC, 32,40,44,45,46 Directive 80/1107/EEC, 24,48, 49, 53, 54, 124,269,274 Directive 88/364/EEC, 49,73 Directive 88/379/EEC, 32,42 Directive 88/642/EEC, 24,48,53 Directive 2004/37/EC, 6,39,47,49,50,73, 235,392,393 Directive 2000/54/EC. 39,52 Directive 91/155/EEC, 40,41 Directive 98/24,6, 39, 47,48,49,55, 175, 183,270,273,274,372,390,391,393 Directive 98/24/EEC, 49

Index Dirty End, 27,338,345 Distributors, 14, 317 DOK-MEGA Databank, 191 Dose, 5,86,294,325 Downstream Supply Chain, 15 DPD, 42,43,44,49,50 DSAC, 88,403 DSD, 40,42,44,49,50 Dual-Limit, 155 Dusts, 2,15,119,187,229,289, 293, 311 Dutch Health Council Expert Committee On Occupational Standards, 91 E ECUPS,43,61,369 Economic Feasibility, 20,26,293,294, 303, 324, 325 EH40, 80,93,127,132,396 EINECS,41,44,209 Electrical Engineering, 173,208 ELINYAE, 23,234,237,250, 255, 256, 369 Employers' Responsibilities, 8 Endocrine Disorders, 18 End-User, 15 Enforcement Authority, 94,95, 96, 97,103, 104,106,107,108,109,110, 111, 112 Enforcement Management Model, 160 Engineering Employers Federation (EEF), 167 Environmental Hygiene, 82, 375, 396 Estimation And Assessment Of Substance Exposure (EASE), 358 ESYPP, 230, 247,254, 355 EU 15, Ii, V, 1,2,9,12,30,36,63,65,66,72, 73, 76, 84, 94,119, 173,227,261, 289, 321, 350 EU Countries, 1,3,4,8,14,28,165,166,169, 264, 335, 343, 344, 354, 356,358 EU Market, 57 EU Provisions, 11, 66 European Chemical Industry Council, 2 European Commission's White Paper, 13 European Community, 5,6, 31, 32, 65, 88, 123,124,125, 126, 229,369 European Council, 24,44,53 European Court Of Justice, 72, 267, 355

409

European Foundation For The Improvement Of Living And Working Conditions, 14, 369,370,376 European Inventory Of Existing Commercial Substances., 41 European Parliament, 40,41,42, 50, 52,57, 387 Evaluation, 12, 57, 59, 375 Exhaust Ventilation, 4,159,253, 334 Existing Legislation, 56 Expert Risk Assessment, 26 Experts, 29,54,85,91,98,101,106,115,190, 273,276,292,307,398,399,400,401,405 Exposure, V, 1,2,5, 6,9,10,11,12,13,14, 15,16,17,18,19,20,21,22,23,24,25,26, 27,31,33,34,35,37,38,39,47,48,49,50, 51,52,53,54,55,56,60,62,65,66,68, 72, 73,74,75,76,77,78, 82, 86,88,89, 93,95, 109, 111, 112,115,116,117,124,125,126, 127, 128,129,130,132,140, 145,148,149, 150,154,155,156,158,160,166,167,171, 172,173,174,175,176,182,183,184,185, 186,189,191,192,194,197,198,199,200, 201,202,203,205,206,208,209,211,212, 213,214,216, 218,220,221,222,225,227, 229,231, 233,234,235,236,240,242,243, 245,246,247, 248,250, 251,252,254,255, 257,259,262, 266,269,271,273, 274,282, 283,284,285,289,291,292,293,294,295, 300,301,303,305,306,307,308,311,312, 313,315,316, 317,319,324,325, 326,327, 328,329,331, 332,333,334,337,338,341, 344,345, 347, 350,351,355,356, 357,358, 359,360,362, 364,365,366, 368, 370,371, 372, 373,374, 375,376, 377, 387, 388, 396, 398,403 Exposure, 19,77, 80, 82,209, 308 Exposure Scenario, 34,189 EXYPP, 230, 239,241, 242, 243, 246,247, 252,253,254, 255,257,258,259,355 F Family-Owned Businesses, 240 Fatal, 18,117,140,295 Federal Ministry Of Economy And Labour, 191

410 Beyond Limits Fibres/M3, 74 Field Operations Directorate, 139 Finland, Ii, 2,68, 77,86,97,325,376,380, 390, 399 FNV, 307, 308 FNV Bondgenoten, 307,308 Formulators, 14,61 Framework Directive 89/391,6, 30,47,62, 72,125, 229, 260,264,267, 273,297, 350, 355 France, Ii, 2,14,69, 72,78,87, 99,114,119, 173,261,380,391,400 Fumes, 2,119, 158,173,227, 229,248, 261, 289,321 Furniture Industry, 11,171,172,195,207, 245,311,313,317

G Gases, 2,74,174,187,337 General Directorate Of Working Conditions, 230 Generic Assessment, 149 German Committee For Hazardous Substances, 194,204 German Federal Institute For Occupational Safety And Health, 175 Germany, Ii, Iii, 2,9,14,18,21,22,69,72, 77,79, 85, 87,91,102,112,114,117,119, 171,172,173,174,175,177, 179,180,181, 183,195,196, 200,205, 208,211,217,218, 224,225,261,274,289, 331,343,345,349, 350,354, 358,360,364,381,392,401 Global Production Of Chemical, 13 Good Occupational Hygiene Practice, 6 Good Practice, 82, 112, 127,149,150, 153, 155,156,157,159,160, 162,284,287,332, 336,338,345,347,350, 353,362,363 Greece, B, Iii, 2,10,23,69, 80, 88, 103,114, 227,228,235,237,240,243,248,253,254, 255,258,260,346,347,348, 352,355,357, 362, 372, 375, 382, 392,403 Guidance Sheets, 150,153 H Hand Sanding Machines, 199 Harmonisation, 20, 359

Hazard Bands, 150 Hazard Identification, 38,40,44, 62 Hazard Information And Packaging For Supply, 122,126,396 Hazard Signs, 52 Hazardous Installations, 3 Hazardous Installations Directorate, 139 Hazardous Substances, 1,2, 3,4,5,6,7, 8,11, 13,15,16,17,18,19,21,22,25,30,32,35, 37, 39,41,50, 53,56, 62,119,121, 122, 123,124,125,126,127,128,132,135,136, 138,139,140,141,145,147,148,151,152, 159,160,161,162,164, 182,185,187,189, 191,197,203,209,222,223,227,228,235, 240,241,246,249,250,251,253,254,255, 259,261,273,307,310,314,320,328,329, 336,338,339,342,343,350,353,354,358, 364,366, 372,401 Health And Safety At Work Act 1568/85,229, 245,247 Health And Safety Authority, 69,88,382,383 Health And Safety Commission, 1,71 Health Based Values, 25 HealthCare, 16 Health Services Act, 105,275 HSA, 88, 104, 382,383 HSC, Ei, V, 1,29,93, 112, 119,123, 129,132, 139,155, 156, 157,159, 354,360, 370, 371, 385 HSWAct 1974, 111, 138,298 Human Contact, 4 I Ill-Health, 16,60,109,261,328,360 Illness, 18, 327 Ilvs, 53,54 Importers, 14, 41,122,209,255 Improvement Notices, 97,103,112,141,142, 240,249,252,253 INAIL, 89, 269,272, 383,403,404 Incorrect Transposal, 72 Indicative Criteria, 128,129,134 Indicative Occupational Exposure Limit Value (IOELV),6,31 Industrial Code 1869,177

Index Industrial Hygiene, 5,22,25,54,185,305, 307, 308 Industrial Users, 14 Information, 1, 5, 8,10, 12, 14, 15, 16, 22,26, 28,29,31,32, 34,35,36,37,40,41,42,43, 45,51,52,55, 58,59,60,61,65,66,73,74, 76, 78, 80,81, 85,87,88,90,91,93,96, 100,101,105,106,108, 111, 116,117,122, 125, 126,131,132,135,136,137,138,139, 140,145,148,149,150,151,152,153,154, 156,157,162,163,164,165,176,181,182, 189,190, 191, 192,205,209,212,213,214, 234,235, 236,237, 240,241,245,249,250, 251,252,254,255,256,261,262,267,271, 273,274,276,282,283,285,287,299,305, 306,311,314,324,327,329,332,336,339, 345, 348,351,361,362,363,364,371,400, 403 Information, 76, 85, 86,89,174,269,270, 271, 294, 398,403 Infringement Proceedings, 72 Inhalable Hardwood Dust, 52 Inhalation Route, 129 INSHT, 90,384, 395,405 INSR.87 Institut National De Recherche Et De Securile, 87 Institute Of Occupational Hygienists, 166 Institutional Structures, I, 37 Institute National De Seguridad E Higiene En El Trabajo, 71,90,405 Intermediaries, 15,163, 352 Intermediary Actors, 163 IOELV, 6,23,31,54, 89,134,154,262,270, 272,387 IOELV Directive, 23 Ioelvs, See IOELV, See IOELV, See IOELV, See IOELV, See IOELV, See IOELV, See IOELV, See IOELV Ireland, H, 2, 69,72, 80,88,104,114,382, 392,403 ISPESL, 89,261,268,269,271,272,273, 277,383,403,404 Istituto Superiore Per La Prevenzione E La Sicurezza Del Lavoro, 70, 89,261, 268, 271,383,403

411

Italy, E, 2,10,14,23,70,72, 80,89,105,113, 115,116,173,261,262,265,268,269,270, 272,273,274,275, 281,287,289, 343, 346, 349, 353, 355, 357, 362, 367,370, 374, 383, 393,403 L Labour Force Survey, 16 Labour Government, 121,142 Labour Inspectorate, 68,71,84,94,95,99, 100, 103, 105, 107, 108, 109,110, 111, 113, 177,189, 230,231, 237, 238,242,245,251, 252,255,269,275,276,277,279,293,299, 300,301,302,305,306,307,308,311,312, 313,314,317,322,323,324,327,331,343, 381,383,384,398 Large Chemical Plants, 35 Large Organisations, 8,165,166 Law 833/78,105,275 Lead, 6,16,24, 31,49, 73, 78, 99,100,124, 133,179,221,234,235,236,240,248,253, 262,266,270,273,283,293,302,311,326, 328, 364,386 Lead, 269 Legal Framework, 37,57,120,128,132,136, 235 Legislative Frameworks, 1,38,65,66 Local Health Authorities (Usls), 268 Luxembourg, Ii, 2,70, 72,81,90,106,368, 369,383,394,404 M MAK.77, 86, 182, 185,205 Maks, 22 Management Of Health And Safety At Work Regulations, 140 Manufacturers, 14,33,41,122,126,187,255, 267, 310,313,332,334,364,401 Manufacturing, 14, 18, 19,114, 153,173,196, 211,215,217,246,248,251,261,285,314, 331 Maximale Arbeitsplatzkonzentrationen, 22, 79, 183,402 Mechanical Engineering, 173 MEL, 93,129, 132,134,143,156,160,162

412 Beyond Limits Metal Manufacture, 11,243,307 Methodology, 7,16 Mg/M3, 56, 74, 186,193, 194, 197,199,202, 203,204,205, 210,213,293, 311, 350 Ministry Of Employment And Social Protection, 69, 88,230 Ministry Of Social Affairs And Employment, 291,293,295,299,385 Mixtures, 42,74, 75,76,77,78,79, 80,81, 87,158,172,183,186,193,207,213,225 Monitoring, 3,5,11,25,55,72,94,95,100, 105, 111, 112,113,117,125,139,151,159, 161,162,166,167,172,175,177,197,202, 217,218,220,221,222,223,224,230,231, 234,236,240,241,243,245,246,247,250, 251,253,254,255,257,258,259,260,271, 275,276,278,279, 280, 282, 284, 285,299, 301,303,304,305,306, 316,317,320,330, 331,334,335,336,338,339, 341,343,344, 345,346, 349, 350, 351, 352, 353, 354, 355, 356,358,359, 363,364,365,399,403 Morbidity, 11,13,16,339,346 Mortality, 11,13,16,17,294,339, 346,370, 372 Multidimensional, 9, 163,164 Multi-Employer Worksites, 8 Multinational Corporations, 14,240 Mutagenic, 43,46,58,73,78,79, 81,182, 185,187 Mutagens, 44,48,50,51,52,76,80, 81,387, 388 N National Board Of Occupational Safety And Health, 90,367,396 National Council For Health And Safety At Work, 69, 88,233 National Institute For Working Life, 91,337 National Institute Of Research And Safety, 87, 101 National Legislation, 23, 72, 386 National Offices For Industrial Safety, 177, 189,190 National Systems, 30,65,66,324,341,343, 344, 357, 359, 363 NEG, 77, 85

Network Of Production, 162 New Substances, 31,32,33,40, 57 Nickel, 46 Nitro Solvents, 247 NIWL, 324, 337, 374 NOAEL,33,158,185,294 Non-Fatal, 18 Nordic Council, 325 Nordic Countries, 84, 85,112,114,115,116, 325 Nordic Expert Group, 77,85, 86 O Occupational Causes, 16,17 Occupational Exposure Limits, V, 1,20,23, 35,54,68,128,129,252,331, 368,371, 373,374, 375,398 Occupational Health And Safety, 1,2,23,24, 29,48,65,66,67,72,88,95,101,114,120, 142,166, 168,177,180,218,219,223,229, 233,254,257,262,263,264,265,268,279, 282, 290, 310, 315,319, 324, 338, 341, 361, 376, 398,400,405 Occupational Hygiene, 3,5,6,19,22,25,93, 114,119,124,125,132,135,138,147,148, 149,150,151,154,155,156,157,158,162, 164,165,166,167,188,284,304,329,330, 343, 344,348,354,372 Occupational Medicine, 3, 54, 107 Occupational Physician, 239,247 Occupational Risk Prevention Centres, 103, 231 Occupational Risks, 4,27,99,101,128 OELs, I, Ii, Ki, Iv, V, 1,3,4,5,6, 7, 8,9,10, 11,12,13,17,19,20,23,25,26,28,29,30, 32,33,34,35,36,37,38,53,54,55,56,60, 61,62,65,66,67,73,74,76,79,80, 81,82, 84,86, 87,88,89,90,91,93,94,95,99, 100,103,104,110, 111, 112,113,114,115, 116,117, 119, 120,122,123,126,127, 128, 130,131,132,133,134,135,136,137,138, 139,140,141,143,144,145,146,147,148, 149,150, 151, 152,154,155,156,157, 158, 159,160,161,162,163,164,165,166,167, 171,172,173,175,176,182,183,187,188, 190,191, 192,196,205,206,207,217,218,

413 Index 413 221,222,223,224,225,227,228,231,233, 234,237, 238, 239,240,245,246,249, 250, 251,252,255,256, 257,258,259,260,262, 263,266,269,270,271,273,274,276,280, 282, 283, 284,285,286,290,291,293, 294, 295,296,299,303,304,305,306,307,308, 309,310,313,315,316,319,320,324, 327, 329, 330, 331, 332, 333, 334,335, 336, 337, 338,339,341,342,343,344,345, 346,347, 348,349,350,351,352, 353,354, 355,356, 357,358,359, 360,361, 362,363,364,371, 373,398,401,403,406 OES, 23,157 Official Journal, 39,40,42,44,45,49,50, 53, 54,55 OHS, V, 1,5,8,9,10,11,12,17,20,28,30, 32,35,48,97,98,101,105, 111, 114,123, 134,150,165,171,178,179,180,200,217, 218,222,224,229,233,237,240,242,243, 246,251,254,255,256, 257, 259, 260,262, 265, 266,272,276, 279, 282,283, 284,285, 286,287,296,297,298,299,300,301,302, 313, 314,315, 319, 321,322,323,330, 348, 349,353,354, 355, 358,359,400,404, See Occupational Health And Safely, See Occupational Health And Safety, See Occupational Health And Safety, See Occupational Health And Safety, See Occupational Health And Safety, See Occupational Health And Safety, See Occupational Health And Safety, See Occupational Health And Safety, See Occupational Health And Safety, See Occupational Health And Safety OHS Services, 299,304 Ordinance On Hazardous Substances (Gefahrstojjverordnung), 175 Organised Labour, 2,3,4,321,336 Outsourcing, 8, 114 Owner Managers, 150,163,164,255,344, 352,363 P Paints, 43,207,252,306,307,309 Participation Of Workers, 4 Participatory Approaches, 27

Penal Sanctions, 103,108,232 Personal Protective Equipment, 127 Pesticides, 149, 174 Pharmaceuticals, 58,149 Photo Chemicals, 43 Physical Containment, 4 Pinpoint Actions, 193,198 Poldermodel, 296,301,310 Policy Makers, 3,18,20,26,29,120,124, 147, 154 Portugal, B, 2,70,81,90,107,384,395,404 Post-Industrialised Market Economies, 3 Ppm, 56,74,186,205,211,212,219,247,338 Precautionary Principles, 4,350 Prescriptive Standards, 19,121 Presidential Decree, 88, 103,229,233, 234, 265,277,392 Prevention Policy, 48,266 Prevention Services, 8,28,114,115,117,147, 165,166,168,230,260,267,284, 319,320, 325,330,333, 335,336,344,348,354,355, 356, 360 Preventive Principles, 8,252,278,322 Printing, 11,171,172,207,208,211,212, 219,220, 223,237,243,245,247,248,249, 250,251,255,256,257,258,307,309,316 Printing, 256 Proactive, 8, 117,314,354 Proactive Regulatory Inspection, 8 Producers Of Chemicals, 38,137 Prohibition Notice, 104 Prohibition Notices, 111, 139,141 Protective Equipment, 4,48, 52, 127,145, 150,153,184, 203,206,253,256,258,267, 405 PSAL, 105,275 Public Policy, 19, 29 Public Trust, 3,20, 357 R R(Isk) And S(Afety) Phrases, 41 REACH, Ii, 12, 32, 33, 34,38, 57, 58,60, 61, 342,351,360,361,368,369 Recommended Limits, 127,128,133 Registration, 12, 57, 58 Regulate Self-Regulation, 31

414 Beyond Limits Regulating. See Regulation, Regulation, 2, 3,4, 6, 8, 9, 10,11,12, 13,14, 15, 17,19,20,23, 25,28,29, 30, 31, 33, 35, 37, 38,40,44,45,47, 60,91, 113, 120,121, 123,124, 125, 142,162, 164, 177, 178,179, 194,207,208,218,224,228,229,230,235, 236,237, 251,254,259, 262, 268, 296, 297, 301,302,310,312, 315, 319,320,321,323, 336,341,342,348,350, 352,353,357,359, 361,362,365,368,370,371,376 Regulation (EEC) 793/93.40.44 Regulation Group., 90 Regulators, 3,20,28,117,124,125,135,162, 164, 346, 347, 362 Regulatory Policies, 11,26 Regulatory Systems, 5, 6, 7, 19,24,28, 31, 65, 116,343,359 Representation, 4,8,89,99,115,123,229, 266,268,281, 314, 336, 369 Respiratory System, 18 Responsible Institutions, 66 Risk Analysis, 28 Risk Assessment, 10,26,28,31, 32, 38,40, 41,45,49, 56, 57,62, 94,125, 137, 141, 142, 145, 146, 151,152, 154,161,183, 209, 218,230,236,239,240,241,242,244,246, 247,249,250, 251, 252,253,254, 256,260, 266,267,274,276,280,281,283,297,298, 299,300,302, 303,305,311,323, 328, 329, 331,332,334,335,339,342,345,347,351, 354,355,357, 360,364, 366 Risk Assessment, 209 Risk Communication, 19 Risk Evaluation, 8, 72, 90,181, 246,290,294, 300,306,315, 336, 354 Risk Evaluation And Control, 8,290,336 Risk Management, 1,12, 17,25,31, 32, 34, 35,37,38,53, 56,61,62,78,115,120,135, 137,138,139,146,147,151,152,154,160, 163,164,169,172,177,224,227,228,235, 238,241,245, 253, 254,256,260, 307, 310, 316, 317, 327,331,339, 341,342, 344,345, 346,347,348,349,350,351,352, 353,354, 356, 357, 358, 359, 361, 363, 364, 365, 366 Risk Phrase R67, 43 Risk Regulation, 20,29

Risks To Health, 5,22, 52,62, 132,154,266, 357, 360 Risque Professionel, 297 Risque Social, 297 Robens, 9,28,121,298,374 Robens Committee, 121 R-Phrases, 126,148,149,150 S SAF, 321 Safe Limits, 19,116,156 Safe Use Of Hazardous Substances, 3,228 Safety Data Sheets, 41,43,126,249,253, 386, 387

Safety Engineering, 3 Safely Engineers, 190,222,230,250,254, 330,355 Scandinavian, 28,319,335 Scientific Basis, 7,24, 87,325, 335 Scientific Committee On Occupational Exposure Limits (SCOEL), 6, 25 Scientific Dossier, 55 Scientific Evidence, 19,85,115,271,403 Scientific Expert Group, 53 Scientific Group For The Surveillance Of The Working Atmosphere, 87,401 SCOEL, 6,25,54,55,76,77,85, 86,91,93, 134,398 SEG, 53,54 Self-Diagnosis, 16 Self-Regulation, 19,30,353 SEPE, 103,230,231,236,237,238,240,243, 252,253,254,258,259,373, 382 Seveso Directive, 44 Skin, 15,18, 33, 56, 75,76, 77, 79,116,143, 149,150,152,153,174,187,193,205,206, 258,293,326,344 Small Enterprises, 2,8,9,19,89,127,149, 164,168,217,221,224,225,249,250,255, 259,264,267,273,280,282,283,311,317, 332,333,334,336, 352,356,363,369 Smes, 255 Social Construction Of Risk, 28,35 Social Dialogue, 4,313,315,318 Social Insurance, 103,105,113,120,176, 218,231,275,343

Index 415 Social Welfare Systems, 16 Solvent, 43,207, 212,213, 219,220, 247,250, 252,309,311,316 Spain, Ii, 2, 71, 72, 81, 90, 108, 114, 173, 374, 384, 395,405 Stakeholder, 88,115,233,343 Standard Setting Structures, 20 State Offices For Labour Protection, 194,197 STEL, 56,75,308 Substitution, 4,38,50,51,60,62,145,214, 215, 222, 224, 237,290, 307, 308, 309, 310, 311,314,315,316,318,339,345,346,349, 350, 358,361,362,364 Supervision, 8, 97, 98,101,109,112,122, 136,160,191 Supplementary Data, 55 Supplier, 15,103,126,136,137, 215,232, 233,351 Supply Chain, 33,61,137,162,163,169,214, 332, 351, 366 Surveillance Surveillance, V, 34, 50, 52, 66,67, 68, 87, 94, 95,99,100,102,105,107,112,160, 172,175,176,177,181,182,184,188, 190, 191,192, 198, 200, 201, 205, 212, 213,214, 215, 216, 218, 221, 222, 223, 224,234,240,267,276,304,316,328, 335, 344, 345, 350,354, 355, 388,401 Sweden, Ii, Iv, 2, 9,24,71, 72, 81, 90, 91, 109,274,319,320, 324,325,333,338,347, 348, 349, 350, 352, 354, 355, 364, 369, 374, 376, 384, 396,405 Swedish Chemical Inspectorate, 332 Swedish Work Environment Authority, 71, 109, 326, 367, 370 SWEM, 323 SYAE, 88,233,234

The National Institute Of Occupational Safety And Health, 89,268,271,383,403 The Netherlands, Ii, 2, 9, 71, 82, 91, 110,293, 373,385, 396,405 The UK, 9,93,119,120 The Work Environment Act Of 1977,322 Third European Working Conditions Survey, 227, 369 Time-Weighted Average, see TWA Tlvs, 5,6,7,21,24,25,26, 81,89,112,115, 116,127,162,237,270,273,295,324,368, 369,376 TolerabilityOfRisk, 130 Toluene, V, 10,171,172,176,205,206,207, 208,209,210,211,212,213,214,215,216, 217,218,219,220,221,222,223,227,241, 245, 246,247,252, 310, 316,373,374 Toluene, 219 Toxic, 5,6,7,43,46,58,76, 78,79, 128,147, 182, 187,205, 227, 254,283,292, 307, 309, 326 Toxicity, 5, 33,52,58,129,134,146,293, 295 Toxicology, 3,22,25,54,126 Toxicology, 91 Trade Union, 8, 10,28, 86,110,121, 136,138, 150, 181, 256,257, 259, 266, 268,275,276, 277,282,285,287,295,300,307, 312,313, 314, 321, 329, 330, 332, 334, 335,336, 356, 364,377,398,405 Traffic Light System, 183,184, 225 Tripartitism, 4 TRK, 23,76,79, 81, 87,117,182,183,184, 185,186,187,188,189,193,197,198,199, 200, 202,203,204,205,221,222, 358, 388, 392 TWA, 56,74,93,247

T

U

Tacit, 243,264 Technical Feasibility, 4,20,23,24,26,55, 84, 86, 90,270,274, 325 Technical Inspection Service, 102,178,190 Technically Feasible, 23,25,26,27,30,265, 282, 307, 337,362, 363 TGW, 79,184

UIL, 274 UK, V, 1,5,6,7,14,16,19,23,24,26,28, 36, 80, 82,88,91,114, 116,119,120,123, 124,125,126,127,128,132,133,135,138, 146,147,151,152,154,155,160,161,162, 163,165, 166,168,169,173,176,225,229, 249,261,274,289,298,331,332,343,344,

416 Beyond Limits 347,349,350, 352, 354,356,358,360,361, 362, 363, 367, 373, 374, 386,387 United Kingdom, Ii, 2, 71, 72, 82, 88, 93, 111, 119,385,396,406 US Federal Government, 21 USL, 105,275,276,277,278, 279, 283, 284, 285

Vapours, 43 Varnishes, 43,207, 307 Ventilation, 51,100,145,150, 153,189, 192, 195, 199, 202, 206, 220, 223,237, 252, 256, 300,305 Vinyl Chloride, 6,24,52, 73,100,234,262, 270,273 Voluntarism, 120,169 Voluntary Standards, 128 Vulnerability, 221 Vulnerable Groups, 48 W WATCH, 93,123, 127,128,129, 132, 134, 406 WEELS, 93 WEL, Iii, V, 82, 93,112,156, 157,158,159, 160

Wels, 157, See WEL, See WEL, See WEL, See WEL, See WEL, See WEL, See WEL, See WEL, See WEL, See WEL, See WEL, See WEL, See WEL White Paper, 13,32,57,368 Wood-Dust, 10,171,172,176,197,200,218, 221,222,223,227,246,273,283,285,317, 328,333,334,349,350,358 Woodworking, V, 194,195,196, 197,203, 245,312,314 Work Environment, 2, 8,109,110,152,162, 166,228,230,231,240,271, 289,290, 297, 314,315,319,320,321,322,323,326,328, 336,337,347 Work Environment Authority, 327,328,337, 338 Work Equipment, 47,267 Worker Consultation, 8 Workers Statute, 266 Working Conditions Act, 110, 300 Working Environment, 3,31,48, 96, 97, 98, 109,122,180,230,237,285, 324,396,400 Working Group On European Exposure Limits, 93 Workplace Exposure, 37 Work-Related Ill-Health, 16