Nanotechnology & Society: Current and Emerging Ethical Issues

Nanotechnology & Society Current and Emerging Ethical Issues

Fritz Allhoff • Patrick Lin Editors

Nanotechnology & Society Current and Emerging Ethical Issues

Editors: Fritz Allhoff Western Michigan University Kalamazoo USA

ISBN: 978-1-4020-6208-7

Patrick Lin California Polytechnic State University San Luis Obispo USA

e-ISBN: 978-1-4020-6209-4

Library of Congress Control Number: 2007940885 © 2008 Springer Science + Business Media, B.V. No part of this work may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording or otherwise, without written permission from the Publisher, with the exception of any material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Printed on acid-free paper 9 8 7 6 5 4 3 2 1 springer.com

Dedication

This volume is dedicated to our families and to our many possible futures. We are indebted to many others, including but not limited to: Western Michigan University, Cal Poly (San Luis Obispo), Fritz Schmuhl, Charles Erkelens, Natalie Rieborn, Rafael Capurro, Brenna Robertson, and all of our esteemed colleagues who have contributed papers to this anthology. Special thanks goes to Marcus Adams for his extensive copy-editing help. This material is also partly based upon work supported by the US National Science Foundation under Grant No. 0620694 and 0621021. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the authors and do not necessarily reflect the views of the National Science Foundation.

Contents

Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Biosketches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Part I Foundational Issues 1

On the Autonomy and Justification of Nanoethics . . . . . . . . . . . . . . . . Fritz Allhoff

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2

The Presumptive Case for Nanotechnology. . . . . . . . . . . . . . . . . . . . . . Paul B. Thompson

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The Bearable Newness of Nanoscience, or: How Not to Get Regulated Out of Business. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Arthur Zucker

Part II 4

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Risk and Regulation

Ethics, Risk, and Nanotechnology: Responsible Approaches to Dealing with Risk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Commission de l’Éthique de la Science et de la Technologie

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Intuitive Toxicology: The Public Perception of Nanoscience . . . . . . . . David M. Berube

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Environmental Holism and Nanotechnology. . . . . . . . . . . . . . . . . . . . . Thomas M. Powers

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Part III Industry and Policy 7 Nanotechnology’s Future: Considerations for the Professional . . . . . . . 127 Ashley Shew vii

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Contents

The Tangled Web of Tiny Things: Privacy Implications of Nano-electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Jeroen van den Hoven Carbon Nanotube Patent Thickets . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drew L. Harris

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Part IV The Human Condition 10

Ethical Aspects of Nanomedicine: A Condensed Version of the EGE Opinion 21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . European Group on Ethics

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Emerging Issues in Nanomedicine and Ethics. . . . . . . . . . . . . . . . . . . Raj Bawa and Summer Johnson

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Nanoscience, Nanoscientists, and Controversy . . . . . . . . . . . . . . . . . . Jason Scott Robert

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Part V Global Issues 13

Nanotechnology and the Poor: Opportunities and Risks for Developing Countries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Todd F. Barker, Leili Fatehi, Michael T. Lesnick, Timothy J. Mealey, and Rex R. Raimond

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Cultural Diversity in Nanotechnology Ethics . . . . . . . . . . . . . . . . . . . Joachim Schummer

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Transnational Nanotechnology Governance: A Comparison of the US and China . . . . . . . . . . . . . . . . . . . . . . . . . . . Evan S. Michelson and David Rejeski

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Foreword: The Double Language of Science, and Why It Is So Difficult to Have a Proper Public Debate about the Nanotechnology Program Jean-Pierre Dupuy

The promoters of nanosciences and nanotechnologies are numerous, powerful and influential: scientists and engineers enthused by the prospect of fabulous breakthroughs; industrialists attracted by the hope of gigantic markets; governments of nations and regions of the globe terrified at the idea of losing an industrial, economic and military race in which the stakes are not only jobs and growth, but also the defense capacities of tomorrow; and, finally, the representatives of that vast and anonymous collective entity made up of everyone who is rushing blindly to find technological solutions to the unintended and undesirable effects produced by technology itself. It is therefore hardly surprising that the benefits for humanity of the scientific and technical revolution now underway are everywhere praised in giddily hyperbolic terms. A rhetorical record has probably been set by the National Science Foundation 2002 report, whose full title is “Converging Technologies for Improving Human Performances.” It foresees nothing less than the unification of sciences and technologies, pacific and mutually advantageous interaction between human beings and intelligent machines, the disappearance of all obstacles to generalized communication and notably those resulting from the diversity of languages, access to inexhaustible sources of energy, and the end to worries about environmental destruction. The report speculates that “the twenty-first century could end in world peace, universal prosperity, and evolution to a higher level of compassion and accomplishment”; and that humanity may eventually “become like a single, distributed and interconnected ‘brain’ based in new core pathways of society” (Roco and Bainbridge, 2002) A few grassroots researchers are lucid enough to realize that, by going too far in lauding the “fabulous” consequences of the revolution underway, one may end up provoking equally exaggerated criticisms bent on nipping it in the bud. If one takes Eric Drexler’s program seriously, then one cannot help being frightened by the unprecedented risks it would entail. The success of Michael Crichton’s novel Prey has made all America aware of the risk of gray goo, also called global ecophagy: the risk that a programming accident could spawn an uncontrolled replication of the nanomachines dear to one of the most (in)famous founders of the nanotechnological program. The biosphere would then be partly or wholly destroyed as the nano-engines in question consume the carbon needed for their self-reproduction. This risk can only frighten those who truly believe such machines are possible. Those who do not share this belief will dismiss the pseudo-risk with a shrug of the shoulders. ix

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Many scientists would agree with the director of the NanoBio project, a showcase for French nanobiotechnology, who wrote to her troops: “I do not think a normal scientist could identify with Drexler’s visions” (Françoise Charbit, private conversation). A tiny minority of researchers, however, admit to having been much influenced by Drexler’s book, Engines of Creation. The truth is that the scientific community uses a double language, just as it has so often done in the past. When scientists need to sell their product, grandiose vistas are conjured up to beguile the politicians who hold the pursestrings. But when the commotion attracts the attention of critics who raise the question of risks, the same scientists beat a hasty retreat, emphasizing the exceedingly modest nature of their research. First we are told that the genome contains the very essence of every living creature; then we hear that DNA is just a molecule like any other—why, it is not even alive! Thanks to GMOs, it is claimed, the problem of world hunger will at last be solved once and for all; then it turns out that humanity has been improving its food supply through genetic engineering ever since the Neolithic. Nanobiotechnologies will give us miracle cures for cancer and AIDS, but there’s nothing new there either—it is just more of what medicine has been doing right along. By resorting to this kind of double language, scientists elude the responsibilities incumbent upon them. “Science does not think,” Heidegger (1977) said. He obviously did not mean that scientists are all thick-headed. The thesis is that science is constitutively incapable of undertaking the type of self-reflection that characterizes all responsible human activity. The debate over nanotechnologies, already intense in the US but still at an embryonic stage in Europe, and especially in my country, France, has every likelihood of degenerating into utter confusion. Reflection will soon be nearly impossible, if indeed that is not already the case. Insofar as it is not yet too late, I would like to make a few suggestions. First, it would be best not to get bogged down in cost-benefit analysis, the calculation of risks or the (very European) tendency to invoke the “precautionary principle.” Not that the development of nanotechnologies is without danger! But the danger is of a sort that conventional methods are powerless to apprehend. Multiplying potential damages by subjective probabilities is an approach ill-suited to assessing the effects of what the technology’s most enthusiastic advocates herald as a “change in civilization.” The essential question is the following one: how has technoscience become an activity so “risky” that, according to some leading scientists, it now represents the principal threat to the survival of humanity?1 Philosophers answer this question by saying that Descartes’s dream—“to become the master and possessor of nature2”—

1 See the much noticed and discussed warning from one of the most brilliant American computer scientists, Bill Joy, published in the very “hip” magazine Wired under the eloquent headline: “Why the future doesn’t need us” (April 2000). Also see the book by the royal British astronomer Sir Martin Rees, Our Final Hour. A Scientist’s Warning: How Terror, Error, and Environmental Disaster Threaten Humankind’s Future in this Century—on Earth and Beyond (New York, Basic Books, 2003). 2 René Descartes, Discourse on Method, John Veitch (trans.) (London: Orion Publishing, 1992 [1637]), VI.

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has gone wrong. They say it is high time we go back and try to “master mastery.” These philosophers do not get it. They have not understood that the technoscience expected to emerge from the generalized “convergence” of disciplines aims precisely at non-mastery. The engineer of tomorrow will not be a sorcerer’s apprentice out of negligence or incompetence, but as a matter of method. He will design complex structures and endow them with the capacity to self-organize, and he will seek to find out what they can do, by exploring the landscape of their functional properties—a “bottom-up” approach. He will be as much an explorer and an experimenter as a maker. His successes will depend more on his own creations’ surprising him than on their conforming to a pre-established set of criteria. Disciplines such as artificial life, genetic algorithms, robotics and distributed artificial intelligence already correspond to this scheme. Moreover, since the scientist will increasingly be someone who explores the properties of his own inventions rather than discovering an independent reality (let us say the artificial intelligence expert rather than the neurophysiologist), the roles of the engineer and the scientist will tend to merge. A grouping of European research centers has adopted the name Nano2Life, which stands for “Bringing Nanotechnologies to Life.” The ambivalence of the expression is a prize example of the double language which I denounced earlier. It can mean, in a modest attitude of retreat, “Bringing nanotechnologies into existence,” or else “Bringing nanotechnologies closer to the life sciences.” But it is impossible not to hear an echo of the demiurgic project of using technology to manufacture life. And the person who wants to manufacture—in fact, to create—life must have the ambition of replicating its essential capacity, which is that of creating in its turn the radically new. Today the nanotechnology lobby is afraid. It fears that its public relations operation may culminate in an even more resounding failure than what was witnessed with genetic engineering. And yet, at the 1975 Asilomar conference, things had gotten off to a good start. The scientific community managed to obtain the exclusive right to regulate the field. Thirty years later, the disaster has been consummated. The public, especially in Europe, sees the smallest biotechnological accomplishment as a monstrosity. Aware of the danger, nanotechnologists look to “communication strategies” for a solution: calming things down, reassuring, establishing “acceptability.” There is something indecent about this ad-biz vocabulary on the lips of scientists. What is to be done? It would be naive to believe in the possibility of a moratorium, or even, in the short term, a legislative or regulatory framework, which, in any event, would have to be worldwide. Such an approach would not stand a chance given the forces and dynamics in play. The best we can hope for is to accompany at the same pace and if possible to anticipate the onward march of nanotechnologies with impact studies and a permanent scrutiny no less interdisciplinary than the nanosciences themselves. A sort of real-time reflection on scientific and technological change would be a first in the history of humanity. The acceleration of the phenomena at issue would seem to make it inevitable. Science, in any case, can no longer evade its responsibility. This obviously does not mean science should be given a monopoly on decision-making power. Few scientists desire this. What it does mean is that science must be forced to abandon

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its splendid isolation from the affairs of the community. The question of the responsibility of science has become much too serious for the debate to be left to scientists alone. The responsibility for decision must necessarily be shared. Yet that is precisely what scientists, as they are trained and organized at present, do not want. They are much happier hiding behind the myth of scientific neutrality: let them go on working to expand knowledge undisturbed, and society can decide where to take things from there. If this kind of talk ever had the slightest relevance, it is unacceptable now. The conditions of possibility for an articulation and division of responsibilities between science and society are not met anywhere today. One of these conditions, the most important perhaps, would call for a mental revolution from both partners. As French physicist Jean-Marc Lévy-Leblond neatly puts it, science needs to be “cultured” (Lévy-Leblond, 1997). To understand science is quite a different thing from keeping abreast of it. The inadequacy of the scientific programs that the mass media offer the public results, incidentally, from the confusion between scientific information and scientific culture. Clearly, the way science is taught at both the high school and university levels must be completely rethought. Adding the history and philosophy of science to the curriculum is a must, but it is far from enough: reflection upon science must be part and parcel of a scientist’s training. From this standpoint, most scientists are no more cultivated than the man in the street. The reason for this is the specialization of the scientific profession. Max Weber (1989) already grasped this back in the early years of the twentieth century. In his 1917 lecture, Wissenschaft als Beruf, he pronounced these chilling words: In our time, the internal situation, in contrast to the organization of science as a vocation, is first of all conditioned by the facts that science has entered a phase of specialization previously unknown and that this will forever remain the case. Not only externally, but inwardly, matters stand at a point where the individual can acquire the sure consciousness of achieving something truly perfect in the field of science only in case he is a strict specialist. […] Only by strict specialization can the scientific worker become fully conscious, for once and perhaps never again in his lifetime, that he has achieved something that will endure. A really definitive and worthwhile achievement is nowadays always a specialized achievement. Therefore, anyone who lacks the capacity to put on blinders, so to speak, […] may as well stay away from science. He will never have what one may call the “personal experience” of science.

Despite their brio, it must be hoped that Max Weber’s analyses will be contradicted by future developments. Scientists with blinders are precisely what our societies can no longer afford to train, maintain and protect. Our survival hangs in the balance. We need “reflexive” scientists: less naive with respect to the ideological dross enveloping their research programs; but also more conscious of the fact that the science they do rests ineluctably upon a series of metaphysical decisions. That said, the nanoethics volume that follows this foreword makes important early steps in overcoming the obstacles in integrating science with our culture. It offers the latest thinking in the field by several leading scholars and organizations worldwide, such as Joachim Schummer, Jeroen van den Hoven, Woodrow Wilson International Center for Scholars, Meridian Institute, European Group on Ethics in Science and New Technologies, and others.

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With a focus on the most critical debates today and in the near future, in contrast to more speculative and distant issues, this anthology introduces the reader to key emerging debates in such areas as: risk, environment, medicine, privacy, intellectual property rights, as well as other global issues and more. As a result, the new work promises to help inform scientists as well as students, policymakers as well as the public, and other audiences concerned about the first impacts of nanotechnology on our lives and on our world. I trust that you, the reader, too will find this volume a welcome addition to the fledgling nanoethics literature that exists today, tempering the “irrational exuberance” and double-talk in nanotechnology with common sense and accountability, as well as helping us to responsibly and realistically prepare for our own future.

References Heidegger, Martin. 1977. Basic Writings. New York: Harper and Row. German: Vortraege und Aufsaetze, II, 7. Joy, Bill. 2000. Why the future doesn’t need us. Wired, April 2000. Lévy-Leblond, Jean-Marc. 1979. L’esprit de sel (science, culture, politique). Paris: Seuil. Rees, Sir Martin. 2003. Our Final Hour. A Scientist’s Warning: How Terror, Error, and Environmental Disaster Threaten Humankind’s Future in this Century—on Earth and Beyond. New York: Basic Books. René Descartes. 1992 [1637] Discourse on Method, John Veitch (trans.) London: Orion Publishing, VI. Roco, Mihail and William Bainbridge, eds. 2002. Converging Technologies for Improving Human Performances: Nanotechnology, Biotechnology, Information Technology and Cognitive Science. Arlington, VA: National Science Foundation. Weber, Max. 1989. Science as a Vocation, eds. Peter Lassman et al. London: Unwin Hyman.

Biosketches

Editors Fritz Allhoff, Ph.D. Dr. Allhoff is an Assistant Professor in the Department of Philosophy at Western Michigan University and a Research Fellow at the Centre for Applied Philosophy and Public Ethics of The Australian National University. He held a postdoctoral research fellowship in the Institute for Ethics of the American Medical Association, as well as at the University of Pittsburgh’s Center for Philosophy of Science. He has numerous publications in nanoethics and nanotechnologies, including, with Patrick Lin, Jim Moor, and John Weckert, an edited volume, Nanoethics: The Social & Ethical Implications of Nanotechnology (Wiley, 2007) and, with Patrick Lin and Daniel Moore, a monograph, Nanotechnology: What It Is & Why It Matters (Wiley-Blackwell, forthcoming). With Lin, Moor, and Weckert, he has recently received a grant from the National Science Foundation to investigate ethical implications in application of nanotechnology to human enhancement. Finally, he is the co-founder (with Lin) of The Nanoethics Group (www.nanoethics.org), a non-partisan organization committed to ethical attention to nanotechnology. Patrick Lin, Ph.D. Patrick Lin is the director of The Nanoethics Group (www. nanoethics.org), a non-partisan organization focused on the social and ethical impact of emerging technologies, especially nanotechnology. He is a visiting assistant professor in the philosophy department at California Polytechnic State University, San Luis Obispo, and also holds academic appointments at Dartmouth College and Western Michigan University. Dr. Lin earned his B.A. from University of California at Berkeley and his M.A. and Ph.D. from University of California at Santa Barbara.

Contributors Todd F. Barker, M.S. Mr. Barker is a Partner with Meridian Institute. Mr. Barker has been involved with and managed numerous nanotechnology projects including the Global Dialogue on Nanotechnology and the Poor: Opportunities and Risks xv

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(GDNP). He has served as the lead facilitator for the GDNP Workshop on Water, Nanotechnology and Development and the GDNP Workshop on Commodities, Nanotechnology and Development. He has been actively involved in the conceptualization, development and management of Nanotechnology and Development News, Meridian’s free, daily news service covering the most important issues at the nexus of nanotechnology and development. He has also been involved with the International Dialogue on Responsible Nanotechnology Research and Development, International Risk Governance Council process on Nanotechnology, and the Dialogue Series on Nanotechnology and Federal Regulation. Mr. Barker received his undergraduate and Master of Science degrees from the University of Michigan. Raj Bawa, Ph.D. Dr. Bawa is a biochemist and microbiologist, is a registered patent agent licensed to practice before the US Patent and Trademark Office (PTO). Currently, Dr. Bawa is an Adjunct Associate Professor at Rensselaer Polytechnic Institute in Troy, New York, where since 1998, he has lectured in numerous courses, including biotechnology, HIV/AIDS, microbiology, immunology and biodefense. He is also an Advisor/Patent Agent at the Office of Technology Commercialization at Rensselaer. Additionally, since 2003, he has been an Adjunct Professor of Natural and Applied Sciences at Northern Virginia Community College in Annandale, Virginia. Since 2002, Dr. Bawa has been president of Bawa Biotechnology Consulting LLC, a biotechnology and patent firm based in Ashbum, Virginia. Presently, he serves on the editorial boards of the peer-reviewed journals, International Journal of Nanomedicine and Nanotechnology Law and Business. He is Associate Editor of the peer-reviewed journal, Nanomedicine: Nanotechnology, Biology and Medicine. He is a Life Member of Sigma XI, a Fellow and Board Member of the American Academy of Nanomedicine, and serves on the Global Advisory Council of the World Future Society. David M. Berube, Ph.D. Dr. Berube has published dozens of articles and numerous chapters in argumentation and in nano-science and technology risk and policy studies. He has written two books including Nanohype: Beyond the Nanotechnology Buzz (Prometheus Press, 2006). He has degrees in psychology, biology, and communication and is a full professor in Communication in North Carolina State University’s graduate school and is the coordinator for the Public Communication of Science and Technology (PCOST) Project. He teaches graduate courses in science communication, risk communication, the rhetoric of fear, and the rhetoric of science and technology. He serves as the principle investigator on a 4-year $1.4 million grant awarded in 2007 by the National Science Foundation to study intuitive nanotoxicology. Commission de l’Éthique de la Science et de la Technologie (CEST). Created by the Government of Québec in September 2001, the CEST’s mission firstly consists in informing, sensitizing, gathering opinions, fostering reflection, and organizing debates on the ethical issues raised by developments in science and technology and, secondly, proposing orientations to guide stakeholders in their decision-making. Since its creation, the CEST has published Position Statements (mainly in French) on ethical issues related to human genetics data banks, genetically modified organisms,

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organ donation and transplantation (also in English), nanotechnology (also in English) and electronic plagiarism. Jean-Pierre Dupuy, Ph.D. Jean-Pierre Dupuy is Professor of Social and Political Philosophy at École Polytechnique, Paris. He also holds a number of appointments at Stanford University, including Full Professor in the French and Political Science departments, researcher at the Center for the Study of Language and Information (C.S.L.I), Science-Technology-Society Program Affiliate, and Fellow of the Symbolic Systems Forum. He is also a member of Académie Française des Technologies. In addition to several books in French, his latest ones are The Mechanization of the Mind–On the Origins of Cognitive Science (Princeton University Press, 2000; MIT Press, 2008) and Self-Deception and Paradoxes of Rationality (C.S.L.I. Publications, Stanford University, 1998). European Group on Ethics (EGE). The EGE in sciences and new technologies is a neutral, independent, pluralist and multidisciplinary body, composed of 15 experts appointed by the Commission for their expertise and personal qualities. The task of the Group is to examine ethical questions arising from science and new technologies and on this basis to issue Opinions to the European Commission in connection with the preparation and implementation of Community legislation or policies. Leili Fatehi. Ms. Fatehi is a Research Associate at Meridian Institute and Editor of Nanotechnology and Development News, Meridian’s free daily electronic news service covering the most important global developments at the nexus of nanotechnology and poverty alleviation. Ms. Fatehi has been involved in Meridian’s on-going Global Dialogue on Nanotechnology and the Poor: Opportunities and Risks (GDNP), for which she has prepared several background papers on such topics as nanotechnology, commodities, and development and comparisons of conventional and nanotechnology-based water treatment technologies. Ms. Fatehi holds a Bachelor of Science in Industrial and Labor Relations for Cornell University. Drew Harris, J.D. Mr. Harris is an attorney with Graves, Dougherty, Hearon & Moody in Austin, TX, and a Co-founder and Managing Editor of Nanotechnology Law & Business, a peer reviewed quarterly journal. He has published and spoken extensively on nanotechnology patent law, particularly with respect to carbon nanotube patent thickets. Mr. Harris holds a Doctorate of Jurisprudence from Stanford Law School, where he was Articles Editor for the Stanford Law Review. Summer Johnson, Ph.D. Dr. Johnson is an assistant professor of medicine at the Alden March Bioethics Institute (AMBI), of Albany Medical College. Dr. Johnson is the director of the Ethics in Novel Technologies, Research, and Innovation program at AMBI. This program conducts conceptual and empirical research related to ethical issues in nanotechnologies, particularly nanomedicine. Dr. Johnson is also the Director of Graduate Studies at AMBI where she runs an online masters degree program in bioethics. She earned her Ph.D. in Health Policy and Bioethics from

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Johns Hopkins University’s Bloomberg School of Public Health and was Jacob Javits Doctoral Fellowship recipient. Dr. Johnson, prior to attending Johns Hopkins, was awarded a Fulbright fellowship to Canada to study embryonic stem cell research. Michael Lesnick, Ph.D. Michael Lesnick is a founder and Senior Partner of the Meridian Institute. Dr. Lesnick has worked domestically and internationally across a range of issues including: environmental quality, national and homeland security, international development, science and technology policy, agriculture, public health, natural resource management, and sustainable development. He is a visiting Senior Fellow at the Vanderbilt University Institute for Public Policy Studies and a member of the National Advisory Committee of the Center for Sustainable Enterprise at the University of North Carolina Kenan-Flagler Business School. He completed his M.S. and Ph.D. in Natural Resource Policy and Management and was a Post Doctoral Fellow in Environmental Dispute Resolution at the University of Michigan, School of Natural Resources. Timothy J. Mealey, M.Pl. Mr. Mealey is a founder and Senior Partner of the Meridian Institute. Mr. Mealey has been involved in several nanotechnologyrelated efforts including, most recently, the Water Workshop of Meridian’s Global Dialogue on Nanotechnology and the Poor. He has served as the lead facilitator of the first two International Dialogues on Responsible Research and Development of Nanotechnology, as well as the Dialogue Series on Nanotechnology and Federal Regulation with the Woodrow Wilson Center, the kick-off meeting of the International Council on Nanotechnology, and the International Risk Governance Council’s Workshop on Nanotechnology Risk Governance. Mr. Mealey holds a Master of Planning from the University of Virginia and a Bachelor of Arts in Environmental Studies and Economics from the University of California Santa Cruz. Evan S. Michelson, M.A. Evan Michelson is a research associate for the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars. He has worked on a wide variety of issues in science and technology policy, including the impact of science and technology on international development, public understanding of emerging technologies, and science and technology foresight. Michelson received a M.A. in international science and technology policy from The Elliott School of International Affairs at The George Washington University, a M.A. in philosophical foundations of physics from Columbia University, and a B.A. in philosophy of science from Brown University. He is currently pursuing a Ph.D. in public administration at the Robert F. Wagner School of Public Service at New York University. Thomas M. Powers, Ph.D. Dr. Powers is an assistant professor of philosophy at the University of Delaware where he also directs the Science, Ethics, and Public Policy program at the Delaware Biotechnology Institute. His research concerns ethics and technology, with a focus on information ethics and emerging technologies. He received his B.A. in philosophy from William & Mary and a Ph.D. from the University of Texas at Austin. He completed research for a dissertation on Immanuel Kant while at the Ludwig-Maximilians-Universität in Munich, Germany,

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as a DAAD-Fulbright fellow. From 2003 to 2005 he was National Science Foundation research fellow at the University of Virginia’s School of Engineering and Applied Science. Rex R. Raimond, L.L.M., J.D. Rex joined Meridian Institute in April 2001 where he designs, convenes and facilitates collaborative processes aimed at helping people solve complex and controversial societal problems. He has worked on local, national, and international projects on issues regarding: nanotechnology; science and technology; international development; intellectual property; agriculture and biotechnology; forestry; water and watershed management; climate and energy; and security. Rex is a key member of Meridian Institute’s team working on the Global Dialogue on Nanotechnology and the Poor: Opportunities and Risks (GDNP), including the GDNP Workshop on Water, Nanotechnology and Development and the GDNP Workshop on Commodities, Nanotechnology and Development. He has been actively involved in the conceptualization, development and management of Nanotechnology and Development News, Meridian’s free, daily news service covering the most important issues at the nexus of nanotechnology and development. He has also been involved with the International Dialogue on Responsible Nanotechnology Research and Development. Rex holds the equivalent of a Juris Doctor from the University of Leiden, the Netherlands and a Master of Environmental Laws from the University of London, UK. David Rejeski, M.P.A, M.E.D. Mr. Rejeski directs the Project on Emerging Nanotechnologies. For the past 4 years he has been the Director of the Foresight and Governance Project at the Woodrow Wilson Center, an initiative designed to facilitate better long-term thinking and planning in the public sector. Jason Scott Robert, Ph.D. Dr. Robert is Assistant Professor of Life Sciences in the School of Life Sciences at Arizona State University, and Assistant Professor of Basic Medical Sciences at The University of Arizona College of Medicine, Phoenix, in partnership with ASU. At ASU, he co-directs the Bioethics, Policy, and Law Program within the Center for Biology and Society, and is a member of the Consortium for Science, Policy, and Outcomes. Dr. Robert co-directs the thematic research cluster on Human Identity, Enhancement, and Biology for the Center for Nanotechnology in Society at ASU. He has published many articles in the philosophy of biology and bioethics, as well as a book in the philosophy of biology, Embryology, Epigenesis, and Evolution (Cambridge University Press, 2004). He is currently writing a book on the moral limits of science. Joachim Schummer, Ph.D. Dr. Schummer is Heisenberg Fellow at the University of Darmstadt. After double-graduation in chemistry and philosophy, Ph.D, and Habilitation (2002) in philosophy at the University of Karlsruhe, he has held teaching and research positions at the University of South Carolina, University of Darmstadt, Australian National University, and University of Sofia. His research interests focus on the history, philosophy, sociology, and ethics of science and technology, with emphasis on chemistry and, since 2002, nanotechnology. His recent book publications include Discovering the Nanoscale (2004, 2005), Nanotechnology Challenges (2006), Nanotechnologien im Kontext (2006), and The Public Image of

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Chemistry (2007). He is the founding editor of Hyle: International Journal for Philosophy of Chemistry (since 1995) and serves on various international committees, including the UNESCO expert group on Nanotechnology and Ethics. Ashley Shew, M.A. and M.S. As a Ph.D. student at Virginia Tech, Ashley Shew studies and publishes on the history and philosophy of technology, with a specific focus on nanotechnology. As an undergraduate, she worked closely with philosophers at the University of South Carolina and others at the industry-leading USC NanoCenter on projects related to the epistemology, history, and ethics of nanotechnology. Paul B. Thompson, Ph.D. Paul Thompson holds the W.K. Kellogg Chair in Agricultural, Food and Community Ethics at Michigan State University. He is the author of The Spirit of the Soil: Agriculture and Environmental Ethics (1995) and Food Biotechnology in Ethical Perspective, which was released in a 2nd edition in March 2007. His latest book edited with Ken David is a collection of essays entitled What Can Nanotechnology Learn from Biotechnology? Social and Ethical Lessons for Nanotechnology from the Debate over Agrifood Biotechnology and GMOs (2008). Jeroen van den Hoven, Ph.D. Dr. Van den Hoven is full professor of moral philosophy at Delft University of Technology and Scientific Director of the Centre of Excellence of the three technical universities in The Netherlands (www.ethicsandtechnology.eu). He is Editor in Chief of Ethics and Information Technology (Springer), member of the editorial board of Information, Computers and Society (Routledge), Journal of Information, Communication and Ethics in Society and consulting editor of Episteme. Van den Hoven is Editor in Chief of the Springer On-line Encyclopedia of Applied Ethics TERP (The Ethics Reference Project) together with Seumas Miller and Thomas Pogge. He has published numerous articles on Ethics and ICT. An edited volume Information Technology and Moral Philosophy will be published by Cambridge University Press in 2007. Van den Hoven is member of the highlevel IST Advisory Group (ISTAG) for ICT and New Media of the European Commission in Brussels. Arthur Zucker, Ph.D. At Ohio University, Dr. Zucker is currently Associate Professor and Chair of Philosophy and Director of the Institute for Applied and Professional Ethics. Zucker has been an editor of the section “Law and Ethics” for the journal, Death Studies since 1984. His most recent publications include: “In Jeopardy: Conflicts of Interest are Everywhere” Association for Applied and Practical and Professional Ethics Monograph, 2005; two entries, “Medical Ethics” and “Philosophy of Medicine,” in Encyclopedia of Philosophy (second edition; 10 vols.; Donald M. Borchert, Editor in Chief. New York: Macmillan Reference USA, 2006); “Medical Ethics as Therapy,” in Medical Humanities, June 2006; and two chapters in the most recent (2007) Handbook of Thanatology (Association for Death Education and Counseling, 2007). He has published four textbooks, all with Prentice Hall.

Introduction: Nanotechnology, Society, and Ethics* Patrick Lin and Fritz Allhoff

Nanoethics, or the study of nanotechnology’s ethical and social implications, is an emerging but controversial field. Outside of the industry and academia, most people are first introduced to nanotechnology through fictional works that posit scenarios – which scientists largely reject – of self-replicating “nanobots” running amok like a pandemic virus (Crichton, 2002). In the mainstream media, we are beginning to hear more reports about the risks nanotechnology poses on the environment, health and safety, with conflicting reports from within the industry. But within the nanotechnology industry, there is a strange schizophrenia afoot. We have heard about the wonderful things that nanotechnology might enable – not just today’s mundane products, such as better sports equipment or cosmetics, but the truly fantastic applications. Our imagination seems to be our only limit, as scientists and other experts predict such innovations as: toxin-eating nanobots; exoskeletons that enable us to leap walls in a single bound; affordable space travel for everyone; nanofactories that can make anything we want; and even near-immortality. Yet nearly in the same breath, many advocates continue to deny or to ignore that nanotechnology will cause any significant disruptions or raise any serious ethical questions that we have to worry about – dismissively labeling these as “hype” (New Atlantis, 2004). But how is this possible? How can such a brave new science, one that is so full of potential that it has been called the “Next Industrial Revolution” by governments and scientists, not also impact our relationships, society, environment, economy, or even global politics in profound ways?1 Let’s take a step back and consider any given technology we have created: gunpowder, the printing press, the camera, the automobile, nuclear power, the computer, Prozac, Viagra, the mobile phone, the Internet. Undoubtedly, these have brought us much good, but each has also changed society in important, fundamental ways and caused new problems, such as increased pollution, urban sprawl, cyber-crimes, privacy concerns, intellectual property concerns, drug dependencies, new cases of

* Part of this paper is based upon earlier works, including Allhoff and Lin (2006) and Lin and Allhoff (2007). 1 For instance: National Nanotechnology Initiative: Leading to the Next Industrial Revolution, National Science and Technology Council’s Committee on Technology, February 2000.

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sexually-transmitted diseases, other unintended health problems, mutually-assured destruction and much more. The point here is not that we would have been better off without these inventions. Rather, we should come to terms that our creations can have unintended or unforeseen consequences. Many of the social problems associated with the aforementioned technologies might have been anticipated and mitigated with some forethought. This is a lesson not lost on policymakers and scientists today, for instance, in having spent millions of dollars to study the ethical implications of decoding the human genome, such as privacy and genetic discrimination concerns. The same lesson, however, apparently was lost on the commercial biotechnology industry, which recently discovered that by ignoring its ethical and social issues – specifically, the possible harm from genetically-modified foods on human health and the environment – they invited a public backlash that crippled progress and sent corporate stocks plummeting. To be sure, no one expects ethicists, scientists, policymakers and other experts to anticipate and address all possible scenarios. It is a plain fact of the human condition that we do not and cannot know everything. We do not fault Thomas Edison, for instance, for the copyright-violating devices that his phonograph would inspire, or Henry Ford for the agonizing commutes we endure daily, or Bill Gates for the email “spam” we receive. And when we try to make predictions about technology, we are often wrong. Consider the following infamous predictions: “This ‘telephone’ has too many shortcomings to be seriously considered as a means of communication. The device is inherently of no value to us” (Western Union, 1876); “Who the hell wants to hear actors talk?” (H. M. Warner, Warner Brothers, 1927); “I think there is a world market for maybe five computers” (Thomas Watson, chairman of IBM, 1943); “With over 50 foreign cars already on sale here, the Japanese auto industry isn’t likely to carve out a big slice of the U.S. market” (BusinessWeek, August 2, 1968); and “There is no reason anyone would want a computer in their home” (Ken Olson, founder of Digital Equipment Corp., 1977). Clearly, it is easy to be too conservative or short-sighted in estimating the future impact of technology. The dangers associated with technology can likewise be underestimated, for instance, as was the case with asbestos, lead paint and the pesticide DDT. But this is not just a failing of our distant past. In 2006 alone, a study has suggested that mobile phones, after all our years of using them, can cause brain tumors and infertility (Hardell et al., 2006). Another study showed that computer manufacturing workers, after decades on the job, are at a much greater risk of death from cancer and other illnesses (Clapp, 2006). In the same year, the U.S. Environmental Protection Agency concluded that a key chemical (PFOA) used to make Teflon – the ubiquitous material used for the last 50 years in non-stick cookware, carpeting, clothing, food packaging and thousands of other products, and traces of which can be found in the blood of nearly everyone in the US and other developed nations – is a carcinogen (USEPA, 2006). At the other end of the spectrum, some predictions also overestimate the role of technology, as was the case with robotic maids, flying cars, meal-in-a-pill, and the death of privacy, for instance. So it is no surprise that the impact of nanotechnology

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should be both understated and overhyped, and in either case, we can trust that it will have consequences that we have not even considered or imagined. However, not being certain about the future does not relieve us of any moral obligation to investigate the issues we can anticipate as being reasonable possibilities or relevant. From the rapid pace of new technologies entering our lives, we can now appreciate that such technologies will have societal implications, for better or worse. Learning from history, we also now understand that we have a responsibility to consider these scenarios in advance to mitigate any harms, if not also to maximize benefits. Discourse into the ethical and social dimensions of nanotechnology – so-called “nanoethics” – is therefore critical to guide the development of nanotechnology. This anthology provides an introduction to many of the most urgent issues today in nanoethics, focusing on current and near-term debates.

1

What is Nanotechnology?

First, we need to be clear on what nanotechnology is before we can appreciate the ethical and social questions that arise therein. Nanotechnology is a new category of technology that involves the precise manipulation of materials at the molecular level or a scale of roughly 1 to 100 nanometers – with a nanometer equaling one-billionth of a meter – in ways that exploit novel properties that emerge at that scale. How small exactly is a billionth of a meter? As one journalist had put it, “If a nanometer were somehow magnified to appear as long as the nose on your face, then a red blood cell would appear the size of the Empire State Building, a human hair would be about two or three miles wide, one of your fingers would span the continental United States, and a normal person would be about as tall as six or seven planet Earths piled atop one another” (Keiper, 2003). Working at the nanoscale, it turns out that ordinary materials can have extraordinary properties, about which we are still learning. At the nanoscale, quantum physics begins to play a key role in the behavior of materials, and the large surface-to-volume ratio of elements means that they are much more reactive. So, for instance, things that are brittle at the ordinary scale may possess superstrength at the nanoscale, and things that do not normally conduct electricity now might at the nanoscale, among other surprising changes to physical and chemical properties. As a specific example of how properties change with scale, aluminum is used ubiquitously to make harmless soda cans, but in fine powder form, it can explode violently when in contact with air. But it is not only about the size: by precisely manipulating common elements at the nanoscale, scientists can fashion new materials. For example, carbon atoms bound together in a relatively-loose configuration may create coal or graphite found in pencils; in a tighter configuration, carbon makes diamonds; and an even more precise configuration, it creates carbon nanotubes, one of the strongest materials known to man, estimated to be up to 100 times stronger than steel at one-sixth the weight.

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Given these new properties, nanotechnology is predicted to enable such things as: smaller, faster processing chips that enable computers to be imbedded in our clothing or even in our bodies; medical advances for dramatically less-invasive surgeries and more-targeted drug delivery; lighter, stronger materials that make transportation safer and energy-efficient (e.g., enabling us to travel farther into space); new military capabilities such as energy weapons and lighter armor; and countless other innovations. Some even predict that nanotechnology will extend our lifespan by hundreds of years or more by enabling cellular repair, which might slow, halt, or reverse the aging process (Freitas, 2004). And because nanotechnology may enable us to manipulate individual atoms – the very building blocks of nature – some have predicted that we will be able to create virtually anything we want in the future (Drexler, 1986). Today, however, research is still continuing on the basic science, so we are years and possibly decades away from most of the fantastic nanotechnology products that have been predicted, if they ever come to fruition at all. Nevertheless, companies are beginning to productize more of their research to create commercially-viable applications based on nanomaterials. These nanotechnology products are quickly entering the marketplace today, from stain-resistant pants to scratch-resistant paint to better sports equipment to more effective cosmetics and sunblock. In fact, Procter & Gamble, as one example of a leading consumer goods company, announced in 2006 that it is looking to incorporate nanotechnology into its products (O’Donnell, 2006). Other notable companies made similar statements recently as well, such as BASF’s plan to invest US$221 million in nanotechnology research and development over just the next three years (James, 2006).

2

Is Nanotechnology a Distinct Discipline?

Before we investigate the myriad issues in nanoethics as covered in this anthology, we must first address a persistent meta-controversy surrounding the status of nanotechnology itself, which casts questions about the legitimacy of nanoethics as its own discipline. Despite massive spending in nanotechnology by corporations and countries – the US government alone is expected to invest over US$1.2 billion in 2007 through its National Nanotechnology Initiative (NNI) – there is still a debate over whether “nanotechnology” is an independent or new science, so unique from other fields that it should require or deserve its own category or moniker. Some have complained that nanotechnology is not distinct from other sciences – or at least its boundaries might be somewhat hazy – and therefore its ethics must be equally ill-defined. Others argue further that nanoethics is not an interesting or distinct field because it does not raise any new questions that are not already considered by, say, bioethics or computer ethics. In the remaining part of this introduction, we will argue that nanoethics should be afforded legitimacy, and we will also set some context for the essays that follow in this anthology.

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At first glance, this controversy seems strange, given that so much is being invested in nanotechnology worldwide. If nanotechnology were not a distinct science, then why does it command so much attention and money? Many people, however, believe nanotechnology to be merely a convergence or amalgamation of several existing disciplines, such as chemistry, biology, physics, material science, engineering, information technology and so on; claims like this have at least some truth. As an example of biology inspiring engineering, scientists are creating artificial noses with nano-sized sensors which can accurately “sniff” out smells that are otherwise imperceptible to humans (Nanomix Inc., 2006). Similar work has been done to create artificial compound eyes (Jeong, 2006), borrowing from nature’s design of insect eyes, as well as artificial skin (Maheshwari and Saraf, 2006) using nanomaterials to mimic the sensitivity of touch. And entire research centers have been created to explore this rich field, including Georgia Institute of Technology’s Center for Biologically Inspired Designs (CBID) and University of California at Berkeley’s Center for Interdisciplinary Bio-Inspiration in Education and Research (CIBER). But does drawing from other scientific areas preclude nanotechnology from being a field in its own right? Consider the similar and ongoing debate in philosophy of science whether chemistry, biology and other established sciences can be reduced to simply physics. One line of thought is that these other fields operate they way they do given the laws of physics that govern how atoms, molecules and their dependent structures interact with each other and the world. But no matter which side of the debate we take here, no one on either side actually suggests that chemistry and biology, for example, do not constitute their own disciplines; so it would be inconsistent to insist that nanotechnology – even if it substantially borrows from other fields – cannot be meaningfully discussed or investigated as a field of its own. As with these other scientific fields, nanotechnology seems to bring something unique to the discussion that merits recognition as its own field; or in other words, it is greater than the sum of its parts. At the least, it appears to be the first to integrate otherwise-distinct fields into this one area. Another source of the controversy about nanotechnology’s ontological status comes from various opinions on when the field was first created. Many point to Richard Feynman in 1959 as the founding father of nanotechnology; others to Norio Taniguchi in 1974; and sill others to K. Eric Drexler in 1986. But as the following statement from physicist Richard A.L. Jones (2006) indicates, a growing sentiment in the field points to a much more recent, and unlikely, person: Perhaps a better candidate to be considered nanotechnology’s father figure is President Clinton, whose support of the USA’s National Nanotechnology Initiative converted overnight many industrious physicists, chemists and materials scientists into nanotechnologists. In this cynical (though popular) view, the idea of nanotechnology did not emerge naturally from its parent disciplines, but was imposed on the scientific community from outside.

So depending on whom one speaks to, nanotechnology might have been first established anywhere from 1959 to 2000. And if former U.S. president Bill Clinton can plausibly claim the title “father of nanotechnology”, then it is no wonder that many scientists and other experts regard nanotechnology as merely a political construct or a marketing buzzword invented to resuscitate old disciplines that appear to be

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losing ground, particularly in the U.S. where the decline of science graduates has been well documented.

3

What is the Status of Nanoethics?

Whether or not nanotechnology is a fabricated area of study and indistinct from other scientific fields, which is not a question we intend or need to answer here, we can already now understand some of the controversy surrounding the status of nanoethics: if nanotechnology is just a fancy term for a range of other fields, then ethical and social questions arising from nanotechnology would seem to be the same kind of questions already raised in these other fields. Indeed, one critic, Sören Holm (2005), asks: It is difficult to specify exactly what could make an area of technology so special that it needs its own ethics, but a minimal requirement must be that it either raises ethical issues that are not raised by other kinds of technologies, or that it raises ethical issues of a different (i.e., larger) magnitude than other technologies. Is this the case for nanotechnology?

Philip Ball, science writer for Nature, elaborates on this point: Questions about safety, equity, military involvement and openness are ones that pertain to many other areas of science and technology [and not just nanotechnology]. It would be a grave and possibly dangerous distortion if nanotechnology were to come to be seen as a discipline that raises unprecedented ethical and moral issues. In this respect, I think it genuinely does differ from some aspects of biotechnological research, which broach entirely new moral questions.

These are fair and forgivable concerns, and current research in nanoethics might even support this position. For instance, in shrinking down devices, nanotechnology is expected to create a new class of surveillance devices that are virtually invisible and undetectable, thereby raising privacy questions; however, according to critics, these questions do not appear to be new but simply an extension of the current debate about privacy. Nanotechnology is also predicted to play a critical role in developing human-enhancing technologies, such as cybernetic body parts or an exoskeleton that gives us superhuman strength or infrared vision; however, society has already been discussing the ethics of such technologies with respect to biotechnology and cognitive sciences. In the more distant future, some people envision nanotechnology’s role in extending the human lifespan to the point of near-immortality; but the question of whether we want or should live longer, or forever – as well as its political, economic and social impacts – does not seem dependent on nanotechnology per se. On the other hand, some issues are emerging that appear unique to nanotechnology, namely the new environmental, health and safety (EHS) risks arising nanomaterials. For instance, research studies suggest that some nanoparticles are directly harmful to animals, and because they can be taken up by cells, they might enter our food chain to unknown effects on human health (Chithrani et al., 2006). Other research asks whether carbon nanotubes will be the next asbestos, since both have the same

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whisker-like shape that makes it so difficult to purge from our lungs if inhaled (Gogotsi, 2003). And the flip side of creating super-strong materials such as carbon nanotubes is their fate at the end of a product life-cycle: will these materials persist indefinitely in our landfills, as is the case with Styrofoam or nuclear waste? (Colvin and Wiesner, 2002) One new ethical issue is perhaps not enough to legitimize the independence of nanoethics. And in fact, we could perhaps reduce even this apparently-unique issue to belong to another discipline, such as engineering or environmental ethics that questions the wisdom of creating products that do not decompose. But there are other good reasons for believing that nanoethics deserves our attention, especially if we believe that nanotechnology itself is a distinct field. First, nanoethics also commands a significant amount of attention and money, though far less than the amount poured into nanotechnology. In the U.S., the NNI currently sets aside approximately $43 million for the “identification and quantification of the broad implications of nanotechnology for society, including social, economic, workforce, educational, ethical, and legal implications” (USNNI). So it would certainly be strange that there would be so much invested by various government agencies, universities, publishers and other organizations globally, if nanoethics were not important as its own field. Of course, there is a possibility that all these organizations and scholars have been fooled because nanotechnology and its ethics allegedly do not exist, but that appears more unlikely than correctly and reasonably identifying nanotechnology as a meaningful area of its own. And at any rate, the point is perhaps already moot given that nanoethics and nanotechnology have taken life of their own. Second, it is unclear why we should accept the litmus test that, to be counted as a new discipline in its own right, nanoethics must either raise new or larger ethical issues than already raised by previous technologies. Looking again at chemistry, for example, whether or not we can properly categorize it as a subset of physics (because chemistry arguably does not raise new questions that cannot be answered by physics), there is no existential dilemma about its status as a legitimate category; no one is proposing to do away with the name or reorganize the university chemistry lab under the physics department. Therefore, it is unclear why such a dilemma would exist with nanoethics, even if nanoethics can be wholly contained within another field or set of fields. Third, to the extent that nanotechnology is a convergence of many disciplines in the first place, it should be no surprise that nanoethics is a convergence of many ethical areas as well. So even if a new area of ethics requires raising new or larger issues, that standard may no longer apply with the discovery or creation of nanotechnology. Rather, nanotechnology might uniquely draw from other disciplines like no other discipline before it. Rather than an argument that nanotechnology is not a distinct discipline because it does not truly break new ground, nanotechnology seems to represent a new pinnacle in our understanding about the world. We are finally able to integrate our learning from a wide range of fields (e.g., physics, chemistry, biology, engineering, and others) to create profoundly useful applications which can be categorized under the moniker

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of “nanotechnology.” So just as, for example, architecture can be regarded as a convergence of aesthetic design and engineering, so too can nanotechnology and nanoethics be rightfully acknowledged even if they are a convergence of other fields. Again, the whole of nanotechnology is arguably greater than the sum of its parts, because of the new synergies or interplay between the various parts. Fourth, nanoethics does seem to raise new ethical issues insofar as it adds a new dimension or “flavor” to current ethical debates. For instance, though privacy may be a relatively old debate, the possibility of creating near-invisible and undetectable devices did not meaningfully exist prior to nanotechnology; so nanotechnology brings a new urgency and reality to the issue of privacy. Further, nanotechnology may help shift the privacy debate in an entirely new direction: whereas worries about unauthorized or unwanted surveillance have traditionally focused on a few agencies, notably governmental organizations, the possibility of cheap, ubiquitous tracking devices “decentralizes” surveillance and changes the terms of the debate. Nanotechnology likewise is putting a new spotlight and elevating other ethical issues, such as related to human enhancement or longevity. Even something as apparently tangential as the ethics of space exploration and settlements – or space ethics – now overlaps with nanoethics, because only with nanotechnology does the possibility of extended space flights and terraforming (i.e., the ability to create a hospitable atmosphere and environment on another planet or moon) become plausible. Finally, it is not even clear that the question of whether nanotechnology and nanoethics are disciplines in their own right has any real consequence to our discussion here. That is, even if we agree that both are not distinct disciplines, it does not follow that nanoscientists and nanoethicists should stop conducting their work, nor does it follow that the massive levels of funding for both nanotechnology and its social impact should be diminished. Rather, it seems that, even if nanotechnology and nanoethics were each comprised of overlapping, established areas in science and philosophy, they nonetheless are comprised of something. Furthermore, it is this constitution that legitimizes the disciplines, not their entitlement to necessarily proprietary issues which continue to exist even if the associative terms of “nanotechnology” and “nanoethics” are successfully challenged. In other words, the debate seems to be more semantic than substantive; this debate is not an obstacle to intelligently discussing either nanotechnology or nanoethics. Even if we agree that both borrow substantially from other areas and therefore should not be considered as distinct disciplines in their own right, we can nevertheless stipulate that we mean “nanotechnology” to be simply short-hand or abbreviations of some longer and unwieldy (yet technically-accurate) descriptors such as, for instance, “the development, characterization, and functionalization of materials based on nanoscale research in chemistry, physics, biology, engineering, materials science, and so on.” And perhaps “nanoethics” means something like “the ethical, social, environmental, medical, political, economic, legal issues, and so on, arising from nanotechnology (as defined by the preceding)” or however we want to precisely define these terms. Regardless, the point is that these terms can be stipulated as is linguistically useful to capture actual investigation in the world; the conceptual independence of those investigations does not deprecate the enterprise.

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Issues in Nanoethics

If nanoethics is a distinct discipline – or even if it is not, but we still understand what the term describes – then what are its issues? Again, controversy surrounds even this question. If we are conservative and only acknowledge those issues that will likely or possibly arise from current lines of research in nanotechnology – which is primarily focused on the discovery and applications of new nanomaterials – then nanoethics certainly covers some of the issues mentioned above: EHS impacts, privacy, human enhancement as well as global security (since the military is a major driver of nanotechnology research to such a degree that some fear a new arms race) (Lawlor, 2005). Other relevant issues may include research ethics (if some research seems to dangerous to publish or pursue), intellectual property (if today’s patent-grab and processes stifle innovation), and humanitarianism (why we are not doing more to solve poverty, hunger, energy, clean water and other problems through nanotechnology). But more imaginative people, such as Drexler, postulate a more advanced form of nanotechnology in our future – sometimes called “molecular manufacturing” – by which we can position individual molecules with exact precision. The difference between how we create nanomaterials today (e.g., carbon nanotubes) with preciselypositioned molecules, and molecular manufacturing is the difference between engineering and chemistry. Carbon nanotubes rely on bulk chemical processes and reactions at high temperatures to create the desired configuration of carbon atoms, which is similar in principle to the usual chemistry experiments in which various elements and compounds are thrown together in bulk and shaken up to predictably create a batch of new compounds.2 In contrast, molecular manufacturing is envisioned to be more like a construction job, grabbing single atoms and deliberately attaching them to others to form the desired structure. This high degree of precision, without messy chemical reactions, would in theory enable us to create practically any possible object. This line of thought is instantiated by a detailed speculative design for a “nanofactory” that might be a portable or desktop device – a black box of sorts – that can create virtually any object we want, from cakes to computers. To oversimplify things, raw materials, say dirt and water, might go in one end, and a raw steak or perhaps an unmanned fighter jet might come out the other. While this may sound like science fiction, the theory behind it seems sound: if we can precisely manipulate molecules, and physical objects are only made up of molecules, then why wouldn’t we be able create any physical object we want? If this still sounds far-fetched, consider the similarities with today’s 3-D printers that can print out plastic or ceramic objects one thin layer at a time. No longer limited to producing only manufacturing prototypes and machine parts, 3-D printers recently

2 Other methods also exist to create carbon nanotubes, e.g., using high-pressure gas or electricity or lasers, but they do not change the point here that existing methods are radically different and less precise than molecular manufacturing.

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broke new ground in printing out fully functional and fashionable footwear, among an expanding and impressive array of print-on-demand products (Engineering & Manufacturing Services Inc., 2006). The nanofactory operates by the same concept, except with much more precision and a mix of different materials. So if advance nanotechnology is in our possible future, then it raises truly unique and serious questions; following the litmus test considered earlier, it may strongly support nanoethics as a legitimate discipline. Molecular manufacturing appears to have the potential to wreak havoc on our economic system where millions might lose their jobs overnight in the manufacturing and other industries and perhaps eliminating the need for global trade. If people and terrorists can easily create weapons with personal nanofactories, that may threaten global security and the lives of millions or billions of others. Some of the more fantastic issues are also related to advanced forms of nanotechnology, if not directly to molecular manufacturing, such as longevity or immortality, space settlements and artificial intelligence. However, because these issues are tied to advanced forms of nanotechnology – the plausibility or likelihood of which is contentious among mainstream scientists – critics may believe that it is inappropriate or well premature to consider such issues now. But we do not need to resolve that question here in order to take seriously the ethical and social issues advanced nanotechnology might raise. Even if advanced nanotechnology is a remote possibility, its scenarios appear so disruptive that they merit consideration. A simple cost-benefit analysis might justify spending $5 million over the next decade to study and perhaps mitigate a scenario that has a 1% possibility of causing $1 billion of economic disruption, which has an expected negative utility or value of $10 million. (These figures are purely hypothetical but appear to be in a plausible range.) As an analogy, if decoding the human genome had just a small likelihood of, say, leading to employment or insurance discrimination based on a person’s genetic predisposition, we would then still expect that scenario to be important enough to warrant an investigation; and in fact, such ethics research has been ongoing in the last decade Or more abstractly, if a political course had even a bare possibility to leading to a devastating war, costing the lives of millions, it seems that we are morally obligated to seriously consider that possibility, no matter how remote. With nanotechnology, so much is still unknown that scientists are really not in a position to accurately forecast what is likely or not and by when. Some believe molecular manufacturing is inevitable; others disagree. But again, if history is any guide, most of our mid- and long-terms predictions about technology will be overly optimistic or pessimistic. Many things we have today were once believed to be impossible or impractical – such as gas streetlights, residential electricity, telephones, highways, radio, airplanes, rockets and even today’s ubiquitous personal computer – so perhaps the prudent course is to treat most of these possibilities as reasonable until proven otherwise. Even near-term challenges in technology – such as how to shrink the smallest computer processor even further – seem difficult if not intractable to us right now, but somehow we find a way to sustain Moore’s Law, which posits a doubling of processing power every 18 months and which some predict will soon fail to hold

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(Zhirnov et al., 2003). Technology is moving rapidly indeed and may be limited now only by our imagination, so it is not implausible to think any technical challenges associated with molecular manufacturing might be eventually solved. Indeed, scientists have recently announced creating a blueprint, and then a working prototype, of an “invisibility cloak” – essentially a heavy blanket created with nanomaterials that can bend, instead of reflect or diffuse, light and other electromagnetic waves around the object cloaked, just as water might flow around a rock in the middle of a stream (Pendry et al., 2006). (This, too, seems to give rise to ethical issues associated only with nanotechnology, namely privacy and security, if we are still interested in identifying unique issues.) But as late as 2006, such innovations would have been thought as merely science fiction, consigned to fantasy worlds such as Harry Potter’s. Again, throughout history and even now, ideas that have been dismissed as unworkable somehow become reality, despite their technical challenges, so it is not irrational to treat molecular manufacturing, space settlements and so on as a real possibility absent compelling evidence to the contrary. Furthermore, no matter how speculative some of these scenarios seem to be, they provide a useful platform to test our moral principles as at least “thought experiments”, which is a commonly-accepted practice in ethics. For instance, no one thinks that anyone would plausibly be kidnapped and surgically connected to a famous violinist – the premature detachment of whom would lead to the violinist’s death – but this hypothetical example isolates and tests out intuitions in Judith Jarvis Thomson’s discussion about the moral permissibility of abortion (Thomson, 1971). Also, few actually question the wisdom of sending spiders into outer space on the grounds that spiders do not exist and may never exist in space (unless we introduce them into space); yet this sort of experiment is useful to study the relationship between gravity and a spider’s ability to orient itself and spin webs by isolating gravity as a variable. As it applies to nanotechnology, even if cybernetic people never exist, the possibility of human enhancement provides a platform, or thought-experiment, to explore intuitions related to human dignity, personal identity and other concepts. Given all this controversy, it should also be no surprise that the questions in nanoethics seem ill-defined as compared to, say, ethical questions in decoding the human genome, as some critics have pointed out (Harris, 2006). Nanotechnology itself is fractured into different approaches or visions, each of which raises it own questions; so, until there is a consensus on what nanotechnology is and will be, it will be difficult to gain a consensus on a plausible set of issues for nanoethics. Moreover, the overlap of nanotechnology with other disciplines – and the overlap of nanoethics with bioethics and other areas – contributes to this challenge.

5

Current and Emerging Worries in Nanoethics

In this anthology, we will focus more on the near-term issues in nanoethics, rather than more distant, speculative issues. We will present global perspectives on several emerging areas in nanotechnology today and by many prominent names in the field.

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In the first unit of this volume, co-editor Fritz Allhoff, in his paper “On the Autonomy and Justification of Nanoethics” considers a different possibility than the one we offered above (but reaches the same conclusion): he builds an argument that, while nanoethics does not raise novel issues, it nevertheless merits attention. Paul Thompson of Michigan State University, in the next paper “The Presumptive Case for Nanotechnology”, draws from recent lessons in biotechnology in rejecting several claims against nanotechnology – arguing that the burden of proof falls on critics to provide reasons to restrict, control, limit, regulate, or moderate the use of the technology, rather than the reverse. Arthur Zucker of Ohio University, in the next paper “The Bearable Newness of Nanoscience, or: How Not to Get Regulated Out of Business”, examines what is “new” about nanoscience and its relationship with ethics, leading up to a recommendation on how we can responsibly proceed ahead with the nascent science. The second unit of this volume deals with the highly-charged topics of risk and regulation. The first paper, “Ethics, Risk and nanotechnology: Responsible Approaches to Dealing with Risk”, is adapted from a recent position paper by Canada’s ethics commission of science and technology, discussing the importance of the precautionary principle as well as a lifecycle approach in dealing with nanotechnology’s risks. North Carolina State University’s David Berube provides the next paper, “Intuitive Toxicology: The Public Perception of Nanoscience”, that investigates the discrepancy between expertly-assessed risks and how the public perceives the same risks, which impacts how we should communicate and manage risks, such as claims of toxicity in nanotechnology-based products. And Tom Powers at the Delaware Biotechnology Institute/University of Delaware, in his paper “Environmental Holism and Nanotechnology” offers a non-anthropological account of the value of nature as we consider nanotechnology’s impact on the environment. The third unit of this volume examines broader issues in law, economics, and public policy – areas important to the success of today’s emerging nanotechnology sector. In the first paper, “Nanotechnology’s Future: Considerations for the Professional”, Ashley Shew at Virginia Polytechnic Institute and State University provides a framework of what a code of ethics might look like for nanotechnologists, acknowledging special challenges such as that nanotechnology is not a single industry but rather cuts across many diverse industries, which may make a code of ethics difficult to enact. Jeroen van den Hoven, professor at Delft University of Technology (The Netherlands), presents the next paper, “The Tangled Web of Tiny Things: Privacy Implications of Nano-electronics”, to address some of the worries about the impact of ever-shrinking devices on our privacy. And in his paper “Carbon Nanotube Patent Thickets”, Drew Harris, attorney and managing editor for Nanotechnology Law & Business, describes and offers a solution to simplify the convoluted intellectual property environment that nanotechnology faces today. The fourth unit of this volume investigates nanotechnology’s ability to improve the human condition. A reprinted excerpt from the European Group on Ethics’ (EGE) recent report “EGE Opinion on Nanomedicine” examines the potential of nanomedicine as well as related ethical issues. Raj Bawa and Summer Johnson

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provide a US-based perspective to the same critical issue in their paper “Emerging Issues in Nanomedicine and Ethics.” And the third paper, “Nanoscience, Nanoscientists, and Controversy” by Jason Scott Robert of Arizona State University, expands on the discussion to look at nanotechnology’s broader ethical challenges in life sciences and biotechnology. Finally, the fifth unit of this volume deals with global issues. Known for its efforts in solving environmental and economic problems worldwide, Meridian Institute lends valuable insight in how nanotechnology can help alleviate poverty in its “Nanotechnology and the Poor: Opportunities and Risks for Developing Countries.” In a reprint of his “Cultural Diversity in Nanotechnology Ethics”, Joachim Schummer of University of Darmstadt (Germany) describes the many challenges facing nanoethics itself, given different and conflicting values among cultures worldwide. Finally, where the opportunities and differences between US and European approaches to nanotechnology and business have been well discussed in other literature, Evan Michelson and David Rejeski of The Woodrow Wilson International Center for Scholars provide a key missing piece to the global discussion in “Transnational Nanotechnology Governance: A Comparison of the US and China.” This collection of papers certainly does not address every relevant issue in nanoethics, but they give a sense of the depth and diversity of ethical and social issues in nanotechnology – particularly in the near- and mid-term. As such, they are meant to provide a starting point for further discussions and investigations. These papers also do not necessarily reflect the viewpoints of the editors or publisher, but only of their authors, whom we thank for their generous contributions. As nanoethics gains momentum, we hope to see more industry experts, academics and the broader public engaged in this critical field – helping to guide science and humanity to a better future.

References F. Allhoff and P. Lin. 2006. “What’s So Special About Nanotechnology and Nanoethics?” International Journal of Applied Philosophy, 2.2, 20(2): 179–190. B. D. Chithrani, A. A. Ghazani, and W. C. W. Chan. 2006. “Determining the Size and Shape Dependence of Gold Nanoparticle Uptake into Mammalian Cells”, Nano Letters, 6(4): 662–668. R. W. Clapp. 2006. “Mortality Among US Employees of a Large Computer Manufacturing Company: 1969–2001”, Environmental Health, 5(30): 1–32. V. Colvin and M. Wiesner. 2002. “Environmental Implications of Nanotechnology: Progress in Developing Fundamental Science as a Basis for Assessment”, Presentation delivered at the US EPA’s Nanotechnology and the Environment: Applications and Implications STAR Review Progress Workshop, Arlington, VA. M. Crichton. 2002. Prey, New York: HarperCollins. K. E. Drexler. 1986. Engines of Creation, New York: Anchor Books, pp. 14, 58–63. The Editors of The New Atlantis. 2004. “The Nanotech Schism”, The New Atlantis, 4(Winter): 101–103. Engineering & Manufacturing Services, Inc. 2006. “On the Job: 3D Printing Gives Footwear Company a Leg Up on Competition”, Paper published by Engineering & Manufacturing Services, Inc.

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R. A. Freitas, Jr. 2004. “Nanomedicine”, The Scientific Conquest of Death: Essays on Infinite Lifespans, Sebastian Sethe (ed.), Buenos Aires: Libros En Red, pp. 77–92. Y. Gogotsi. 2003. How Safe are Nanotubes and Other Nanofilaments?” Material Research Innovations, 7(4): 192–194. L. Hardell, M. Carlberg, and K. H. Mild. 2006. “Pooled Analysis of Two Case-Control Studies on Use of Cellular and Cordless Telephones and the Risk of Malignant Brain Tumours Diagnosed in 1997–2003”, International Archives of Occupational and Environmental Health, 79(8): 630–639. R. Harris. 2006. “Nanotechnology: More Than Just a Buzzword?”, Presentation delivered at the University of California, Santa Barbara, Center for Nanotechnology and Society. S. Holm. 2005. Does Nanotechnology Require a New ‘Nanoethics’? Cardiff Centre for Ethics, Law and Society. K. James. 2006. “BASF Sets Aside $221 million for Nano R&D, Opens Asian Center”, Small Times. K.-H. Jeong, J. Kim, and L. P. Lee. 2006. “Biologically Inspired Artificial Compound Eyes”, Science, 312(5773): 557–561. R. A. L. Jones. 2006. “Hollow Centre”, Nature, 440(7087): 995. A. Keiper. 2003. “The Nanotechnology Revolution”, The New Atlantis, Summer(2): 19. Maryann Lawlor. 2005. “Small Matters”, Signal Magazine/AFCEA, p. 47. P. Lin and F. Allhoff. 2007. “Nanoscience and Nanoethics: Defining the Disciplines”, Nanoethics: The Ethical and Social Implications of Nanotechnology, Fritz Allhoff, Patrick Lin, James Moor, and John Weckert (eds.), Hoboken, NJ: Wiley, pp. 3–16. V. Maheshwari and R. F. Saraf. 2006. “High-Resolution Thin-Film Device to Sense Texture by Touch”, Science, 312(5779): 1501–1504. Nanomix Inc. 2006. “Nanomix and UC Berkeley Announce E-Nose Detection Collaboration”, Press release by Nanomix, Inc. National Nanotechnology Initiative: Leading to the Next Industrial Revolution. 2000. National Science and Technology Council’s Committee on Technology. K. O’Donnell. 2006. “Procter and Gamble Eyes Nanotech”, MarketWatch. J. B. Pendry, D. Schurig, and D. R. Smith. 2006. “Controlling Electromagnetic Fields”, Science Express, Science DOI: 10.1126/science.1125907. J. J. Thomson. 1971. “A Defense of Abortion”, Philosophy and Public Affairs, 1(1): 47–66. U.S. Environmental Protection Agency (USEPA). 2006. “EPA Seeking PFOA Reductions”. U.S. National Nanotechnology Initiative (USNNI) website, accessed on November 13, 2006: http://www.nano.gov/html/society/home_society.html. V. Zhirnov, R. Cavin, J. Hutchby, and G. Bourianoff. 2003. “Limits to Binary Logic Switch Scaling – A Gedanken Model”, Proceedings of the IEEE, 91(11): 1934–1939.

Chapter 1

On the Autonomy and Justification of Nanoethics*† Fritz Allhoff ‡

Abstract In this paper, I take a critical stance on the emerging field of nanoethics. After an introductory section, Section 1.2 considers the conceptual foundations of nanotechnology, arguing that nanoethics can only be as coherent as nanotechnology itself and then discussing concerns with this latter concept; the conceptual foundations of nanoethics are then explicitly addressed in Section 1.3. Section 1.4 considers ethical issues that will be raised through nanotechnology and, in Section 1.5, it is argued that none of these issues is unique to nanotechnology. In Section 1.6, I express skepticism about arguments which hold that, while the issues themselves might not be unique, they nevertheless are instantiated to such a degree that extant moral frameworks will be ill-equipped to handle them. In Section 1.7, I draw plausible distinctions between nanoethics and other applied ethics, arguing that these latter might well identify unique moral issues and, as such, distinguish themselves from nanoethics. Finally, in Section 1.8, I explore the conclusions of this result, ultimately arguing that, while nanoethics may fail to identify novel ethical concerns, it is at least the case that nanotechnology is deserving of ethical attention, if not a new associative applied ethic.

* With minor changes, this paper is reprinted from Fritz Allhoff, “On the Autonomy and Justification of Nanoethics”, Nanoethics: Ethics for Technologies that Converge at the Nanoscale (2007). Used with permission. † I thank John Weckert and Patrick Lin for discussions regarding the ideas in this paper; I also thank Marcus Adams for extensive comments on a draft. Parts of this paper were presented at the Australasian Association of Philosophy’s 2007 meeting (Armidale, Australia) and at The Governance of Science and Technology, a conference hosted by The Australian National University. I thank all the participants in these sessions for valuable input. Finally, I thank two anonymous reviewers—as well as feedback given to one of those reviewers by an anonymous third party—for their helpful comments on the penultimate version of this paper. ‡ Department of Philosophy, Western Michigan University and Centre for Applied Philosophy and Public Ethics, The Australian National University. Please direct correspondence to fritz.allhoff@ wmich.edu.

F. Allhoff, P. Lin (eds.) Nanotechnology & Society: Current and Emerging Ethical Issues, © Springer Science + Business Media B.V. 2008

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1.1

F. Allhoff

Introduction

Nanotechnology has been hailed as the “next Industrial Revolution” (National Science and Technology Council’s Committee on Technology, 2000), and promises to have substantial impacts into many areas of our lives. These impacts will be manifest through many of the novel applications that nanotechnology will enable; these applications will take advantage of features that are only realized through nanoscale manipulations. And, through these technological advances, many ethical and social questions will, or have been, raised (Allhoff et al., 2007). These questions have given rise to the emergent field of nanoethics, which has been characterized by substantial research funding and an explosion of publication outlets (including this one). What has yet to happen, though, is any sort of sustained and critical metadiscussion regarding the field of nanoethics itself: what is this field? What delimits it? What is special about it? These questions can be answered by any number of platitudes—such as “nanoethics is the study of the ethical and social dimensions of nanotechnology”—but these answers are extremely limited in their elucidation. First, they seem to presuppose that there are such dimensions, and that is precisely one of the issues at stake. Second, and less obviously, they presuppose that the notion of nanotechnology itself is a coherent one: for nanoethics to be related in some way to nanotechnology, the former concept can only be as sensible as the latter. In this paper, I want to try to see what legitimacy can be conferred upon nanoethics. In particular, I will be interested in whether there are any ethical issues that are unique to nanotechnology and, if not, what implications that has for the field itself. Ultimately I will argue that, while there are not substantially novel ethical implications raised by nanotechnology, this fact does not undermine the need for ethical attention to nanotechnology, as well as the need for associative public and political forums. In other words, I think that nanoethics lacks any metaphysical autonomy (from other areas of applied ethics), but I nevertheless think that the field can receive a pragmatic justification. I take this pragmatic justification to be weaker than a metaphysical one, but a justification nonetheless.

1.2

Conceptual Foundations of Nanotechnology

As I mentioned above, I take it that nanoethics can only be conceptually coherent as nanotechnology itself. The reason is that the former has to, at least in some sense, be predicated upon the latter. Most intuitively, “nanotechnology” must be used in the definition of “nanoethics” as, for example, the above conception that “nanoethics is the study of the ethical and social dimensions of nanotechnology”. But of course, if we said that “bachelors are unmarried males” and “males” or “married” were nonsensical concepts, then “bachelors” would be nonsensical as well. So, insofar as nanoethics could (and, usually, is) defined by reference to nanotechnology, the former only makes as much sense as the latter.

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So, what is nanotechnology? This is a question that has already been addressed elsewhere, so I will not linger too long (Allhoff and Lin, 2006). But, while there might be independent reasons for coming up with some specific conception of nanotechnology, the point of the question in this paper is that the question bears directly on the cohesiveness of nanoethics. A common definition, and one that is good enough for these purposes, comes from the National Nanotechnology Initiative (US) “nanotechnology is the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications.” (National Nanotechnology Initiative, n.d.).1 This definition, then, seems to suggest two necessary (and jointly sufficient) conditions for nanotechnology. The first is an issue of scale: nanotechnology is concerned with things of a certain size. “Nano -” (from Greek nannos, “very short man”) means one billionth, and, in nanotechnology, the relevant billionth is that of a meter. Nanometers are the relevant scales for the size of atoms; for example, a hydrogen atom is 7.874 × 10 −10 ft in diameter, which is an unwieldy scale to use since we could rather describe the same dimension as about a quarter of a nanometer. The second issue has to do with that of novelty: nanotechnology does not just deal with small things, but rather must deal with them in a way that takes advantage of some properties that are manifest because of the nanoscale (Allhoff et al., 2009). Either one of these conditions raises conceptual difficulties for nanotechnology. Regarding the issue of scale, there are simple boundary issues that are already welltrod among philosophers: imagine that some nanostructure has some dimension of 110 nm. Or 150 nm. Or 230 nm. Are there principled reasons for excluding some of these structures from the realm of nanotechnology? At least one point is that the 100 nm upper-bound for nanotechnology is more conventional than “real”, and that conventions have their limits. In deciding whether some structures that lie just outside this range are therefore impervious to any dialogue about nanoethics, we need not to take such stipulative definitions too seriously. Also regarding the issue of scale, it is an odd feature of the NNI definition that it is silent as to the issue of dimensionality. Our world is comprised of three spatial dimensions, and the nanoscale might be appropriate to some of these dimensions, but not others. For example, nanoscientists distinguish between zero-dimensional

1 As an anonymous reviewer pointed out, this definition is ambiguous between two readings: whether the novelty attaches to the matter at 1–100 nanometers or whether it attaches to nanotechnology itself. Ultimately, the interpretation hinges on the semantics of the clause following the comma, which could be read either restrictively or non-restrictively. Consider, for example, “marsupials are mammals who lay eggs.” In this case, “who lay eggs” is a restrictive clause used to distinguish egg-laying mammals from non-egg-laying mammals. Alternatively, consider “marsupials are mammals, who lay eggs.” In this case, the more natural reading of “who lay eggs” is as a non-restrictive clause which suggests that all mammals lay eggs. If the comma makes the difference, then, the novelty attaches to the matter at the nanoscale, and not (necessarily) to nanotechnology itself. But this then falsely suggests that all matter at that scale manifests such novelty given the scope of the non-restrictive clause. Rather, it seems that nanotechnology should manifest the novelty, and the semantics of this definition are therefore misleading. I thank the reviewer for these insights, as well as the linguist that she/he consulted in providing them.

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nanostructures, one-dimensional nanostructures, and two dimensional nanostructures. For reasons completely beyond my comprehension, the nomenclature here is to identify the number of dimensions that are not confined to the nanoscale: zerodimensional nanostructures (e.g., quantum dots) are confined to the nanoscale in all three dimensions; one-dimensional nanostructures (e.g., nanowires) are confined to the nanoscale in two dimensions; and two dimensional nanostructures (e.g., nanofilms) are confined to the nanoscale in one dimension (Allhoff et al., 2009). On the NNI definition, it is not clear whether, for example, nanowires count as nanotechnology since they have one dimension that exceeds 100 nm. Maybe the idea is that nanotechnology has at least one dimension that is on the nanoscale but, first, this is rarely made explicit and, second, it is not immediately clear why one, as opposed to two or three, is the relevant number of dimensions. Second, as the NNI definition intimates, any serious definition of nanotechnology has to transcend mere scale: simply because a few atoms have been isolated, it hardly follows that there is nanotechnology. Rather, the point has to be that such technology requires the demonstration of phenomena that are manifest because of their occurrent scale and, furthermore, these phenomena have to be harnessed in some relevant way such as to be productive. Intuitively, then, the NNI definition seems to be headed in the right direction, but there is no easy way to resolve much of the ambiguity that it invites. In particular, what are “phenomena”? What does “novel” mean? How about “application”? There are at least some straightforward cases. For example, nanotechnology enables previously impossible surface to volume ratios and, insofar as the surface of materials is the most reactive, novel applications are indeed possible.2 A washing machine that uses silver nanoparticles to kill bacteria (Silver Institute, 2003) works precisely because there is simply more silver surface put into contact with more bacteria, so this application takes advantage of a straightforward feature of nanoparticles and, undoubtedly, produces a novel application. And, in addition to surface to volume ratios, nanotechnology can take advantage of other features, such as quantum effects, unique bonding patterns and lattice arrangements, and so on. But, while there might be cases that obviously satisfy the requirement that “unique phenomena enable novel applications”, there are other cases where this is far less clear. For example, some baseball bats are now fortified with carbon nanotubes, which make the bats stronger. The strength/density ratios of the nanotubes clearly take advantage of nano-properties, but it is less clear what the “novel application” is. Certainly it is novel to embed the nanotubes into a baseball bat, but the application (that of hitting a ball) is hardly novel at all. Even if the ball goes a little further. The point of this discussion is not to nitpick the definition offered by the NNI which, again, is very standard and, I think, as good as any other. Rather, the point is supposed to be that these sorts of definitions necessarily draw arbitrary lines and 2 The surface of a sphere is given by A = 4πr2 (where r is the radius of the sphere) and the volume is given by V = 4πr3/3. The surface to volume ratio, then, is 3/r so, as the radius gets smaller, the surface to volume ratio goes up.

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invoke vague concepts which, when pushed on, might be susceptible to challenge or confusion. Maybe there are other ways to offer the definitions than the philosophically preferred method of offering necessary and sufficient conditions,3 but I do not see any of them as being completely unproblematic.

1.3

Conceptual Foundations of Nanoethics

So, for now, let us assume that we have a handle on what nanotechnology is and then try to figure out what we are talking about when we talk about nanoethics. As I said above, it might be fairly common to understand this as pertaining to the ethical and social implications of nanotechnology. It is worth noting, though, that even this conception seems oddly incongruent with nanoethics, which does not make any obvious reference to social implications (at least those that do not have ethical upshots). Sometimes the social and ethical implications are grouped together as SEIN (social and ethical interactions with nanotechnology)4, but the territory is littered with all sorts of other acronyms as well, such as NELSI (nanotechnology’s version of ELSI—ethical, social, and legal implications—that was first associated with the Human Genome Project) or NE3LS (nano-ethical, environmental, economic, legal, and social issues) (Keiper, 2007). I think that many of these acronyms are generated to enjoin some sort of self-importance that plays well to funding bodies, but they betray a lack of conceptual unity. Are environmental issues part of nanoethics? Legal issues? Or, as already mentioned, social issues? As the field seeks an identity, it has to be clear about what is part of it and what is not, and the proliferation of disparate acronyms challenges such a conception. It has to be the case that ethics cuts across various other inquiries, among them social, legal, environmental, and economic. Furthermore, it is probably the case that many of these other inquires have non-ethical components. For example, figuring out how extant patent law applies to nanotechnologies is not a simple issue (Harris, 2008), but it is not obviously an ethical issue either, particularly if we just

3 See, for example, Schummer (2008), Section 2. Schummer identifies, in addition to the traditional “nominal” definitions, both “real” and “teleological” definitions for nanotechnologies. Real definitions refer to a list of particular research topics, though it still seems to me that there will be vagueness as to what is or is not on this list. Or else that the list is so fluid across time as to not be of much use in the first place. Teleological approaches define nanotechnology in terms of its future goals, but then it seems that there are the obvious problems of whose goals should count in such an analysis, and different constituencies would obviously have different goals. Furthermore, those goals are, again, fluid across time, so this would not lead to stable definitions. Regarding this last point, which was again made against “real” definitions, I take it that one desideratum of definitions is that they should be (at least mostly) persistent; it would not make much sense to say that, today, bachelors were unmarried males but, tomorrow, they were something else altogether. 4 Baird and Vogt (2004). Some understand “SEIN” as “social and ethical implications of nanotechnology”, but I do not see this as a relevant difference.

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refer to the issues of legal interpretation (which might be normative, if not ethical) and not to what fair laws should be. Similarly, there are issues about how nanotechnology will affect the environment (Myhr and Dalmo, 2007). Some of this is just going to be basic science, and that is not (immediately) ethical in nature, but there are ethical questions about what sort of environmental practices are morally permissible (or obligatory). Nano-economics will be an issue, particularly with the implications that nanoscience has for the developing world (both in terms of what it offers and in terms of what the latter might not be able to afford) (Schummer, 2007b). Again, there are probably two ways to analyses for these impacts, which can be ethical and non-ethical. Regarding the latter, it is an open question what the economic impacts will be, and this is just a factual question. But there are also ethical questions that those facts will raise, particularly as pertain to issues of distributive justice. The point, then, is supposed to be that some of these ethical questions are very proximate to, if not inextricably bound up with, some of the non-ethical questions that will be raised by various other (viz., non-ethical) questions into nanotechnology’s impacts. In developing our conception of nanoethics, it certainly becomes complicated as we try to delimit a field that is so closely interrelated to various other ones; many of these boundaries will be blurred or attenuated at best. It is not clear to me, then, how separable the social, legal, economic, and environmental issues are from the ethical ones, as many of these acronyms seem to suggest. I think that, as we move forward, these complexities are important to recognize. Nonetheless, what seems more important to me than what we call the field (i.e., which acronym we favor) is what the field amounts to.5 And, insofar as some of the ethical issues will have social upshots, or else will involve legislation, the environment, or economic policy, we might just end up with a fairly broad nanoethics. What remains to be seen, though, is precisely what these ethical issues are, as well as the implications that those issues have for circumscribing an autonomous applied ethic. In Section 1.4, I will deal with the first issue and, in Section 1.5, the latter.

1.4

Issues in Nanoethics

Regardless of how we define nanoethics and how we draw its boundaries, it must, at the end of the day, be the sort of discipline that is constituted by various ethical issues. Whether those issues are sufficient to confer autonomy upon the field remains to be seen, but certainly the existence of relevant ethical issues is a necessary—if not necessarily sufficient—condition for delimiting an applied ethic. In this section, I want to present briefly some of the ethical issues that nanotechnology allegedly raises. The point here is not to do this in tremendous detail, which is both

5 In this, I am sympathetic to the “real” approach discussed by Schummer. See footnote 3 above, where I mention some misgiving about it but, practically (if not theoretically), it has some advantages.

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inappropriate for the task in hand and, regardless, has already been done elsewhere.6 Rather, the idea is to get some ideas on the table that will be useful for the remainder of this discussion.7

1.4.1

Legal and Regulatory Issues

Nanotechnology will pose challenges to extant legal and regulatory schemes, some of which will be strained or compromised by technological advancement.8 Consider, for example, patent law, which will have to accommodate developments in nanotechnology. Taking carbon nanotubes in particular, there are four patent law doctrines which could be used to challenge their patenting. These doctrines (from the U.S. Patent Act) include whether the new product is: patentable (35 U.S.C. §101); anticipated by prior art (§102); obvious given prior art (§103); and “enabled” (for production, given the patent; §112) (Harris, 2008). And, in this particular case, meeting any of those criteria is going to be a challenge (Harris, 2008). Regarding regulations, some of the current frameworks are inadequate to deal with nanotechnology (Lin, 2007). For example, regulations exist to secure the safety of substances that exist either in the workplace or in public; these regulations mandate the creation of materials safety data sheets (MSDS) which contain information regarding the properties of those materials, including the potential hazards that they present. At present, MSDSs for carbon nanotubes and fullerenes are identical to those used for graphite. While these are all carbon allotropes, they have very different physical and chemical properties (and, presumably, hazardous properties as well) (Baird and Vogt, 2004). Another example is Samsung’s “Silver Wash” washing machine, which uses silver nanoparticles to kill bacteria. There are worries that the nanoparticles could be discharged and concentrate in water treatment plants, where they might kill bacteria that are supposed to be detoxifying wastewater. The Environmental Protection Agency (US) has now classified this washing machine as a pesticide and subjected it to appropriate legislation (Royal Society of Chemistry, 2006). The producers of the washing machine, however, can avoid this legislation by simply removing claims that their washing machine kills bacteria. Whatever else we want to say about this case, the classification of a washing machine as a pesticide seems forced, and the “opting out” conditions for the regulation seem too lax. As nanotechnology

6

In addition to this book, see Allhoff et al. (2007). The following list is becoming more or less standard, but there are two sources that I have paid especially close attention to in drafting it. See Baird and Vogt (2004). See also Robert (2008), especially Section 2. 8 While I will have nothing specific to say about intellectual property, this is closely related—if nevertheless orthogonal in some respects—to legal and regulatory issues. See Robert (2008) for brief mention therein. The following discussion of patents, though, reveals some of the issues that attach to intellectual property as well. 7

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enables either non-traditional applications of traditional products or else allows novel products altogether, it will be imperative to decide whether extant frameworks are adapted to accommodate these developments or whether those frameworks are jettisoned in favor of new ones altogether.

1.4.2

Research Funding and Priorities

Nanotechnology research commands huge sums of money, and that investment is growing rapidly. In the United States, research commitments have risen from $116M in 1997 (Roco, n.d.) to over a billion dollars in 2005 (National Nanotechnology Initiative, n.d.). By some measures, this might not seem like a tremendous amount of money. For example, the United States allocated $439B to the Department of Defense in FY2007 (Office of the US President, n.d.), which is two orders of magnitude greater than its investment in nanotechnology. Nevertheless, this is still a lot of money that could have been put to some other purpose. Is this too much money to invest in nanotechnology? As with all issues in federal funding, there are a multitude of projects competing for a limited number of dollars, and some determinations must be made as to how to spend it. If funding into nanotechnology comes at the expense of other projects to which governments bear ethical obligations—e.g., security, health care, retirement, etc.—then that funding needs to be justified. In addition to the funding that nanotechnology commands—or, more precisely, because of the funding that it commands—it exerts an influence on the entire scientific community. This influence is manifest in various ways. Examples include: personnel (as scientists who research something else turn to nanotechnology); institutions (as Centers and Institutes are developed for nanotechnology’s pursuit); cultures (as nanotechnology becomes trendy, develops journals, conferences, societies, etc.), and so on. In all of these cases, we can ask whether the influence is good or bad. While neither nanotechnology nor its funding is going to go away, it is surely the case that we can substantively ask whether the investment levels for nanotechnology—including the non-monetary ones just mentioned—are appropriate or whether they should be reconsidered.

1.4.3

Equity

As mentioned above, nanotechnology will raise issues regarding fair distribution; issues regarding nanotechnology and the developing world will be particularly acute (Schummer, 2007b; Schummer, 2008). While I have already mentioned water purification as a potential environmental application for nanotechnology, it is worth emphasizing that 1.1 billion people lack access to safe drinking water, and that this leads to millions of deaths a year, especially among children in poor Asian and African countries (World Health Organization, 2004; quoted in Schummer, 2007b). Nanotechnology may very well offer the potential to mitigate many of these

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problems, but the countries most in need will be those most unable to afford the new technologies. Second, nanotechnology may be used in solar energy production, particularly through applications in photovoltaics. If solar power becomes available, this will bear substantial impact on rural communities since those communities will lack access to central power plants and grids (Schummer, 2007b). Many of these communities may be under- or unpowered, and the application of nanotechnology to cheap and widely available solar energy could have substantial impacts. Third, there are medical applications of nanotechnology that will be of primary importance to the developing world. For example, consider HIV/AIDS, which generated 4.1 million new infections in 2005, and 2.8 million deaths; these infections and deaths were borne disproportionately by the developing world (UNAIDS, 2006). Against this backdrop, consider an Australian company which has a developed a dendrimer, SPL7013, which might be used in a vaginal microbial gel to prevent HIV infection during intercourse.9 Because dendrimers fall under the purview of nanotechnology, this means that nanotechnology has the potential to play a serious role in HIV/AIDS prevention. These examples, of which there are others, show that nanotechnology could provide substantial benefits to the developing world. Again, though, the developing world is going to be unable to afford many of the technological interventions that would be so valuable. Questions are then raised about equity and distributive justice: the developed world will have access to technologies that the developing world will not, and then we must ask—especially in light of the tremendous benefits that the developing world could receive from these technologies—whether this is morally acceptable.10

1.4.4

Environment, Health, and Safety11

As Baird and Vogt (2004) succinctly write: “[n]anotechnology’s promise is that it will provide new means for pollution remediation and less toxic ways to manufacture goods. However, latent toxicity is the flipside: nanosize materials are interesting because their physical and chemical properties differ so radically from 9

Schummer (2007b), p. 298. For an associated scientific study, see Jiang et al. (2005). It is also worth pointing out that, though the discussion herein has been framed in terms of the developed versus developing world, issues of equity can cut against different axes as well: rural/ non-rural; carbon-based/non-carbon-based economies; oil and non-oil producing regions, etc. This nanodivide, therefore, can be far more insidious than merely trans-continental. See Baird and Vogt (2004), p. 393. I follow Schummer (2007b), though, in thinking that the questions regarding the developing world are the most perspicuous, which is not to say that others might not be profitably explored. 11 Environmental impacts are sometimes treated separately from health and safety ones, though they are often treated together as well. For present purposes, I think that they can be properly consolidated. Generally, my view is that a sufficiently broad conception of “environment” covers the health and safety issues as well, though I will use the more standard “environment, health, and safety (EHS)” locution. 10

12

F. Allhoff

bulk amounts of chemically the same compounds. Some of these differences are useful and wanted, but others have the potential to be less desirable.” In the way of specifics, nanotechnology is likely to enable more efficient and effective water filtration, options for cleaning up oil spills, various coatings (to protect against the environment) and, potentially, artificial photosynthesis (Allhoff et al., 2007). But these applications carry risks with them as well. For example, one study has linked buckyballs (i.e., synthetic carbon molecules of a specific orientation) to brain damage in fish.12 Also, studies have indicated that carbon nanotubes can lead to toxic effects in mice (Lam et al., 2004). Certainly there are issues worth discussing in these studies—in particular, the delivery mechanism in the mice study is unlikely to be naturally occurrent—but they at least highlight some of the potential impacts that nanotechnology could have on the biological world.13 And, of course, the environmental implications of nanotechnology could (directly) affect humans as well (Myhr and Dalmo, 2007). Particularly at risk could be those who work in factories where production might lead to the liberation of nanoparticles into the air; worker safety is surely a legitimate ethical concern. In addition to toxicity, there are other ethical issues that pertain to nanotechnology and the environment. For example, as water purification becomes more efficient and effective, it might be the case that we then incur duties to apply these technologies (as against inefficient and ineffective previous generations thereof). Furthermore, the availability of environmentally positive nanotechnologies may change the moral status the developed world bears to the less-developed (and, in particular, the environmentally compromised) world; for more on equity issues, see Section 1.4.3 above. Most basically, then, there will be questions about whether we can use these technologies (given toxicity and other risks), whether we have to use these technologies (given obligations of environmental stewardship), and whether we have to share them (given obligations to international distributive justice).

1.4.5

Privacy14

Another area in which nanotechnology will have an impact is in terms of monitoring and surveillance (Khushf, 2004; see also Gutierrez, 2007). New sensor and surveillance technology is being enabled by the rapid development of submicron technologies and nanotechnology. Many nanotechnologies, from lithography to molecular electronics are helping to make computing devices smaller and faster; these developments will continue into the foreseeable future. Devices for signal

12

See Oberdörster (2004). For a follow-up study, see Zhu et al. (2006). For a discussion of some of the interpretive issues, see Berube (2008). 14 The following section is excerpted and adapted from Allhoff et al. (under review). 13

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detection, solar energy collection and a variety of mechanical, electrical and chemical operations are being miniaturized at the micrometer level, and all of these technologies together provide the means for such devices as Radio Frequency Identity Chips (RFIDs) (Schummer, 2007a). RFIDs are already widely used for tracking and tracing various items (Jules et al., 2005). An RFID chip or tag consists of a small integrated circuit attached to a tiny radio antenna, which can receive and transmit a radio signal. RFID tags are now also being used to trace and track consumer products and everyday objects as a replacement of barcodes (Kardasiadou and Talidou, 2006). Governments and the global business world are preparing for a large-scale implementation of RFID technology in the first decades of the twenty-first century for these purposes (van den Hoven, 2006). As RFIDs become smaller, they may well become too small to be seen by the naked eye or otherwise be undetectable given extant or (widely) available technologies. Monitoring and surveillance capabilities are not the only areas that will be enhanced by the kinds of tracking and sensing devices already discussed: allied health fields—and, in particular, their use of medical records—deserve much discussion in this regard. Lab-on-a-chip technologies, for example, will facilitate very rapid, economical, and comprehensive medical diagnosis and screening, and the rapid decoding of genetic dispositions could become possible in normal clinical work. But as with the concern raised in the Human Genome Project, employers or insurance companies could pressure individuals to make this information available, and the data could be monitored by the employer (Schmid et al., 2006). This clearly raises worries about privacy and data protection. In all of these applications, questions can be raised about the relevant (moral) benefits and costs. The benefits will be manifest through increased safety and security or, in medical applications, through improved outcomes. The costs will be impingement upon individuals’ rights and liberties, particularly those that pertain to privacy (whether in general or with medical records in particular). A corollary of these costs will be who might have access to the information: presumably many— though perhaps not all—of the costs might be mitigated by delimiting proper custodianship of personal information. However, protecting the custodianship will be non-trivial, and there will surely be disagreements as to which custodianships (and of what) should be constituted in the first place.

1.4.6

Medicine

Nanotechnology will have applications to medicine—often called nanomedicine or, more broadly, bionanotechnology—and these applications will raise ethical questions (European Commission Group on Ethics in Science and New Technologies, 2007). For present purposes, let us focus on three such applications: treatment, diagnostics, and delivery (Ebbesen and Jensen,2006; see also Bawa and Johnson, 2008).

14

F. Allhoff

Nanotechnology enables surgical techniques that are more precise and less damaging than traditional ones. For example, a Japanese group has performed surgery on living cells using atomic force microscopy with a nanoneedle (6–8 µm in length and 200–300 nm in diameter) (Obataya et al., 2005; quoted in Ebbesen and Jensen, 2006). This needle was able to penetrate both cellular and nuclear membranes, and the thinness of the needle prevented fatal damage to those cells. In addition to ultra-precise and safe surgical needles, laser surgery at the nanoscale is also possible: femtosecond near-infrared (NIR) laser pulses can be used to perform surgery on nanoscale structures inside living cells and tissues without damaging them (Tirlapur and König, 2003). Because the energy for these pulses is so high, they do not destroy the tissue by heat—as conventional lasers would—but rather vaporize the tissue, preventing necrosis of adjacent tissue (Ebbesen and Jenson, 2006). There are also non-surgical treatment outcomes that will be facilitated by nanotechnology. For example, gold nanoparticles show potential for noninvasive cancer treatment (National Cancer Institute, 2005a). Many cancer cells have a protein, epidermal growth factor receptor (EGFR), distributed on the outside of their membranes; non-cancer cells have much less of this protein. By attaching gold nanoparticles to an antibody for EGFR (anti-EGFR), researchers have been able to get the nanoparticles to bind to the cancer cells (El-Sayed et al., 2006). Because the gold nanoparticles differentially absorb light, laser ablation can then be used to destroy the attached cancer cells without harming adjacent cells. Similar strategies can also be used to effect improved diagnostic outcomes (National Cancer Institute, 2005b). Again, gold nanoparticles, by using anti-EGFR, can be used to bind to cancer cells. Once bound, the cancer cells manifest different light scattering and absorption spectra than benign cells (El-Sayed et al., 2005). Pathologists can thereafter use these results to identify malignant cells in biopsy samples. These results offer the promise of a generalization: nanoparticles can be differentially bound to something of interest—be it cancerous or whatever—then there will be potential for increased diagnostic power and, hopefully, better treatment outcomes. Relatedly, delivery options can also be improved. Some therapeutic agent can be attached or adsorbed onto a nanocarrier which could then go on to deliver it to some precise location (again, by invoking various binding parameters) (Ebbesen and Jensen, 2006). This localized delivery will have the advantage of being more targeted (i.e., so that the agent gets where it needs to be) and minimizing side effects (i.e., so that the agent does not get anywhere other than where it is supposed to be). Regarding ethical issues, toxicity will play a central role as we have limited information about the nanoparticles used in some of the treatment, diagnostic, and delivery applications mentioned above. How will these interact with the human body? How will they be processed after their use? While not mentioned above, these technologies could also be used for genetic interventions (by providing the delivery mechanisms), and there are ethical issues therein, including the traditional therapy/enhancement debate. There will also be issues of access, insurance, etc. as these technologies are not likely to be inexpensive (at least in the near term).

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1.5

15

What’s New?

In this section, I want to go through the social and ethical issues raised in the previous section and to argue that none of them is new or novel in any substantial way. As this part of my project has been addressed—if less systematically—elsewhere (Grunwald, 2005; Lewenstein, 2005; Litton, 2007), I will not belabor these points, but rather will try to quickly establish preliminary conclusions that will go on to form the basis for the rest of this paper.

1.5.1

Legal and Regulatory Issues

As mentioned in Section 1.4.1, there are questions about how to integrate nanotechnology into extant legal and regulatory frameworks, and some of those frameworks seem ill-equipped to accommodate these new technologies. This challenge, though, is surely not novel and rather continually presents itself with new technologies (or, in fact, just about anything that is substantially new). For example, consider cloning. After the cloning of Dolly in 1997, there was substantial confusion and discord about what should be done in legal and regulatory capacities; previous laws and regulations were predominantly silent about this technology.15 The resolution in that case was various funding moratoria and public denouncements, though these have, to some extent, abated in more recent years (Cantrell, 1998–1999). Regardless of the details of that case, there were straightforward questions about what should be done given the advent of this new technology, and there were various outcomes effected. Nanotechnology is not going to be subject to similar outcomes—e.g., wholesale funding moratoria are off the table—but whatever process by which new technology is integrated into our laws and regulations can be applied, mutatis mutandis, to nanotechnology. This is not to say that it is obvious what such a process is, or even that such a process is simple, either to conceive or to apply. But the point is that nanotechnology, as such, does not differ, in any relevant way, from other technologies that need to be accommodated. To be sure, nanotechnology is different from other technologies, and many of the empirical facts about nanotechnology will be relevant to its assimilation. For example, the precise details of carbon nanotubes are relevant to their patentability, and the toxicity specifications for various carbon allotropes are relevant to their regulation. But these facts are irrelevant to the frameworks by which we effect legal and regulatory reform, and nanotechnology does not raise any novel issues in such regards. The relevant questions there are such as the following: do the current laws make sense? Are they effective? Fair? Are the current regulations

15

For a discussion of the legal issues following the cloning of Dolly and those surrounding the ban on human cloning in the US, see Swartz (2002). Also see the report from the UN Ad Hoc Committee (n.d.).

16

F. Allhoff

sufficient? Should they be strengthened or weakened? Do they provide a proper balance between autonomy and safety? And so on. These questions—or whatever the appropriate questions are—must be answered in the context of nanotechnology, but nanotechnology itself has nothing to say about what the questions are or the process by which we must answer them; the questions and the processes transcend nanotechnology completely.

1.5.2

Research Funding and Priorities

In Section 1.4.2, I discussed a worry that can be lodged against nanotechnology, which is that it commands funds (and other non-monetary resources) that are then diverted from other projects, some of which have ethical import. For example, investments in nanotechnology are not ones that are (directly) being made into feeding the poor, improving education, and so on. Again, though, this is just not a substantially new issue. While various examples might serve to make this point, I think that one of the most appropriate has to do with the debate about bioterror defense funding (May, 2005; see also Allhoff, 2005a). There are at least three substantial parallels between bioterror and nanotechnology spending: both reflect fairly recent spending priorities; both display exponential funding growth in a short number of years (e.g., within the past decade); and both programs are challenged by somewhat to fairly limited knowledge about outcomes. These first two points about nanotechnology were made in Section 1.4.2, but it is worth emphasizing these parallels by noting that, in the United States, bioterror defense funding has increased from $305M in FY 2001 to $5.2B in FY 2004 (cf., investments in nanotechnology, which are roughly on the same order of magnitude) (May, 2005). Regarding knowledge of the outcomes, a worry about investment in nanotechnology is that it might not deliver on its promise or else that it might end up leading to various hazards. Or, independently, that the money should just be more appropriately spent somewhere else. Bioterrorism has the same structural features: we do not know whether our investment will preclude attacks or, relatedly, whether it is either more money than we need to be spending to prevent such attacks or else not enough money to prevent those attacks. Or, independently of whether such attacks could be prevented, we could ask whether it would nevertheless be better to spend the money elsewhere (and perhaps either absorb the attacks or otherwise just hope that they do not occur). The similarities with the non-monetary considerations mentioned in Section 1.4.2 apply, mutatis mutandis, as well (e.g., what our researchers work on, what institutional structures and infrastructure we effect, etc.). So, whatever concerns can legitimately be raised about nanotechnology research funding and priority, they are simply not new concerns; again, the bioterrorism example was chosen for structural similarity, but any range of other examples could work as well. To be clear, this is not to say that these discussions do not need to be held about nanotechnology, since the details (e.g., regarding expense, outcomes, etc.)

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will be different in this case than they would be in any other. But no new ethical questions are raised by merely asking the old ones in a different context.

1.5.3

Equity

In Section 1.4.3, concerns were presented about how nanotechnology could lead to the nano-haves and the nano-have nots: the technologies will only be available to limited constituencies, at least in part because the formers’ acquisition will take money and technical knowledge that will not be universally available. Against such a disparate allocation, we might worry about issues pertaining to fairness and distributive justice. Again, this worry is not novel. Any range of examples might make this point, but an appropriate one might be the debate about various medical technologies and, in particular, genetic interventions (Allhoff, 2005b). Commentators in these debates have similarly worried that genetic interventions will only be available to a limited few; maybe this is especially worrisome in germ-line enhancements that will resonate through all future generations. Even in this case, it seems to me that the issue has nothing to do with the genetic technologies themselves, but rather with theories about distributive justice. Maybe such disparities are only justifiable if they benefit all of society.16 Or else maybe those who can afford the technologies are entitled to create whatever disparities might thereafter result (Nozick, 1974). The point is that whatever questions we want to ask about equity are ones that float free of the genetic technologies in particular. Rather, we have to figure out which account of distributive justice we want to adopt, and then we figure out whether that account would be violated by some extant (or forthcoming) practice regarding those technologies. Nanotechnology, then, would work the same way: nanotechnology itself is silent as to issues of fairness and justice, but rather must be applied and developed in ways that comport with our broader theoretical commitments regarding these issues. Regardless, the starting point has to be some debate about those issues in particular, and nanotechnology does not elucidate such a debate in any substantive way.17 16

See, for example, Rawls (1999). (Rawls advocates a “difference principle” by which inequalities are justified only if they make the least-well off class better off.) 17 Having just mentioned Rawls (footnote 16 above), it should be acknowledged that a Rawlsian reflective equilibrium might benefit from having particular cases by which to consider these broader theoretical commitments. So, for example, we might imagine some disparity, and this disparity might violate our sense of justice; to the extent that this is true, any principles which license such a disparity might be revised to achieve equilibrium with our considered judgment in that particular case. But, while we might have considered judgments regarding distributions of nanotechnologies, I am extremely skeptical that there could be anything special about those technologies such that similar judgments could not be structurally replicated in multiple ways. If this is true, then the appeal to nanotechnology, while perhaps effective, would not be necessary; nanotechnology would then not play any essential role in the discourse.

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1.5.4

F. Allhoff

Environment, Health, and Safety

As discussed in Section 1.4.4, nanotechnology has the potential for impacts upon the environment, health, and safety. Most succinctly, these concerns center around the following: relatively high surface areas, crystalline structures, and reactivity of nanoparticles and nanomaterials; the biological interactions of ultrafine nanoparticles; and the (in)visibility of some of these particles (Myhr and Dalmo, 2007). As in Section 1.5.2, it might help to draw a specific analogy as well as to make some more general comments. In way of the analogy, consider asbestos, which manifests various of the health hazards that are concerns with nanotechnology (e.g., inhalation, lung problems, etc.) (U.S. Department of Health and Human Services, 2001). Despite recognition by the Greeks that asbestos caused damage to weavers, it achieved widespread usage during the 1860s as insulation, and deaths from asbestos were documented since the early 1900s (Mesothelioma Resource Center, n.d.). Nevertheless, a conclusive link between asbestos and mesothelioma—a specific form of cancer caused nearly-exclusively from asbestos exposure—was not recognized until 1960 (Keal, 1960). In the United States, approximately 10,000 people die each year from mesothelioma and other asbestos-related diseases (Environmental Working Group, n.d.). As mentioned above, this case mirrors some of the concerns that attach to nanotechnology. In the latter, we do not know what the consequences will be, but we suspect, in at least certain scenarios, that there are risks (Lam et al., 2004). It is obvious that we need to make reasonable provisions to determine what those risks are, as well as develop effective measures to mitigate them (Myhr and Dalmo, 2007. As in the asbestos case, we may also have to consider some sort of legal remediation process for harms that are ultimately affected (American Bar Association, 2006). More generally, though, philosophers (and others) have already developed accounts of how to think about risk.18 Relatedly, there is a large literature on the so-called precautionary principle;19 independently of its various formulations and controversies, this principle roughly says something about what remedies we should apply given the possibility that some practice will cause a harmful effect (Weckert and Moor, 2007). Whichever the approach, all accounts must at least evince the obvious commitments: to assess the costs and benefits for the relevant practice; to think about constraints or limitations that might apply to cost-benefit

18

See, for example, Rescher (1983), Thompson (1986), Hansson (1996), Chicken (1998), and Hansson (1999a). A more comprehensive bibliography can be found at http://www.infra.kth.se/ phil/riskpage/bib2.htm (accessed August 14, 2007). 19 Bodansky (1991), O’Riordon and Cameron (1994), Cross (1996), Martin (1997), and Hansson (1999b). A more comprehensive bibliography can be found at http://www.infra.kth.se/phil/riskpage/ bib3.htm (accessed August 14, 2007). This issue is discussed specifically as pertains to nanotechnology in Weckert and Moor (2007). See also Phoenix and Treder (2004). Available at http:// www.crnano.org/precautionary.htm (accessed August 14, 2007).

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analysis; to explore alternative practices that might mitigate negative effects (though perhaps lack some of the associative benefits); as well as to consider the relevance and proper handling of epistemic uncertainty. Whether such ideas are applied to the environment, marketing practices, a medical procedure, or anything else, the central framework should be invariant as all such applications share those same structural features. Nanotechnology, then, should be subjected to some relevant framework, but there is no good reason to think that it has any features which challenge such frameworks altogether or otherwise introduces any novel moral considerations into those frameworks.20

1.5.5

Privacy

As discussed in Section 1.4.5, nanotechnology can be applied in ways that challenge privacy. In some cases, this might be through RFIDs, which are used to increase surveillance and tracking capacity, though other applications will be possible as well. In the medical arena, tracking chips might provide ready access to a patient’s information, at the prospective cost of being intercepted or otherwise accessed by unintended parties. The question now is whether these implications for privacy raise any new worries, and, again, I think that they do not. Most fundamentally, the non-medical issues center around two competing values: privacy and security. It is not a dramatic oversimplification to say that, as privacy increases, security decreases, and vice versa: whatever information is reserved to individuals (through protections of their privacy) is, ex hypothesi, not information that can be put to other ends, such as security. Conversely, whatever information is annexed for security purposes is, ex hypothesi, no longer reserved to the individual. While this framework has many nuances that can be explored (Schoeman, 1984; Roessler, 2005), I nevertheless take it to be roughly correct. And, once this framework is generalized away from the particulars of nanotechnology, then we can see that it can be otherwise instantiated. Consider, for example, the United States Patriot Act,21 which was passed in the October, 2001, 45 days after the attacks on the World Trade Center in New York City. For present purposes, let us focus on Title II, “Enhanced Surveillance Procedures”, which, among other things, gives the federal government the authority to intercept wire, oral, and electronic communications relating to terrorism (§201). While there are various philosophical issues that could be talked about in this context (Perrine, 2005; Brandt and Otter, 2005; Weldon, 2005), the simple point is that the Patriot Act increases surveillance at the expense of privacy: private communications are no longer reserved to individuals but can rather be accessed by the government.

20

Note that this conclusion is not challenged in Weckert and Moor (2007). H.R. 3162. Available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname = 107_ cong_bills&docid = f:h3162enr.txt.pdf (accessed August 15, 2007).

21

20

F. Allhoff

The debate, then, is whether these interventions are justified given individual rights as well as the likelihood that possible infringements would be productive. The case of nanotechnology is structurally identical in this regard insofar as it manifests the same costs and benefits. The one potential difference—which I take to be morally insignificant—is that the locus of control lies with the government rather than outside of it.22 For anyone who objects to the example, we might pick another one, such as privacy at the workplace, Internet privacy, and so on (Miller and Weckert, 2000; Weckert, 2002; Weckert, 2005); the same features are still on display. I do think it is worth noting that debates about privacy often take place in technological contexts (DeCew, 1997), though I see nothing inherently special about those contexts such that they change the moral landscape. Regardless, nanotechnology is just one technology among many (including those that would be applied to realize the goals of the Patriot Act as well), and I see no special challenges that it, qua nanotechnology, raises for privacy.23

1.5.6

Medicine

In Section 1.4.6, applications of nanotechnology to medicine were discussed. Particular focus was paid to three areas: treatment, diagnostics, and drug delivery. In each of these cases, nanomedicine has much to offer, though issues in toxicity/ safety, insurance, and access will surely arise. In this section, let me take those three areas and draw connections to non-nanotechnological applications, showing that the issues in these regards are isomorphic with those in nanotechnology. I will draw on examples that focus on toxicity/safety, though examples could be generated that apply to other issues as well. Starting with treatment, the principal worry is that some of these treatments could be damaging. To wit, the hope is that the treatments are less damaging than conventional treatments, but hazards loom regardless. Of particular concern is the toxicity from nanoparticles that might be used (e.g., in cancer treatment), as well as other safety concerns. Consider, for example, chemotherapy, which uses cytotoxic drugs to treat cancer. The downside of chemotherapy is that these drugs are toxic to the benign cells as well as the malignant ones, and there are side effects such as immunosuppression, nausea, vomiting, and so on. When physicians are prescribing

22

This is not to say that I take governments to be morally insignificant, just that the introduction of a government instead of some other entity does not alter the moral structure of the case. 23 In the medical contexts, perhaps it is the case that the calculus shifts somewhat insofar as privacy is now no longer opposed by security per se, but rather by improved outcomes: as privacy increases, those outcomes become less likely, and vice versa. Again, though, this formal structure lacks any features endemic to nanotechnology; whatever debates need to be held can be executed within this framework—informed by empirical details of nanotechnology—without the framework itself being altered.

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chemotherapy, they therefore have to think about these risks and whether the risks are justified. Whether the treatment option involves nanoparticles or not, this basic calculus is unchanged: physicians must choose the treatment option that offers the best prognosis. Toxicity or side effects count against these outcomes, and improved health counts in favor of them. Obviously, there are epistemic obstacles to such forecasting, and physicians must be appraised of the relevant toxicity and side effect data, but there is nothing endemic to nanotechnology that raises new issues for the process. Diagnostically, the concerns with nanomedicine also center around toxicity. Conventional diagnostic mechanisms, however, manifest the same structural features as nano-diagnostics. Consider, for example, x-rays, which use electromagnetic radiation to generate images, and these images can be used for medical diagnostics. This radiation, absorbed in large dosages, can be carcinogenic,24 so medical personnel have to be judicious in their application thereof. The radiation outputs for x-rays are reasonably well-understood, as are their toxicities in regards to human biology.25 As when considering treatment options, medical personnel must consider these toxicities, as well as the benefits of this diagnostic mechanism (perhaps as contrasted with other options). Nano-diagnostics admits of a similar deliberative model.26 Finally, consider drug delivery. Nanotechnology has the potential for more targeted delivery, though there are again worries about toxicity. This concern, though, can be manifest about other delivery mechanisms. Consider, for example, the celebrated case of Jesse Gelsinger, who died in a gene therapy trial (Philipkowski, 1999). Gelsinger had ornithine transcarbamylase deficiency: he lacked a gene that would allow him to break down ammonia (a natural byproduct of protein metabolism). An attempt to deliver this gene through adenoviruses was made, and Gelsinger suffered an immunoreaction that led to multiple organ failure and brain death. Whether talking about vectors for genetic interventions or nanoparticles, we surely have to be worried about toxicity, immunoreactions, and other safety concerns. Nanotechnology does not change our thinking about these things in any substantive way. Again, we need to know what, for example, the toxicities are for nanoparticles, but this is an empirical issue and not a moral or a conceptual one.

24

Note that one of the pioneers of radioactivity, Marie Curie died from aplastic anemia, which was almost certainly caused by exposure to radiation. Rosalind Franklin, whose work on x-ray crystallography was critical to the discovery of the double helical structure of DNA contracted ovarian cancer at a relatively young age; again, her work was almost certainly responsible. 25 There have been numerous studies of the effects of the use x-ray technology in diagnostic procedures. For a recent overview of data relating to risk of cancer see de Gonzalez and Darby (2004). Also, see Kereiakes and Rosenstein (1980); and National Research Council (1990). 26 It is worth noting that part of the concern about nano-diagnostics is that the toxicities are patently not well-understood. While true, this is irrelevant to the formal deliberative model that is under discussion.

22

1.6

F. Allhoff

It’s a Revolution!

In this section, I want to consider an argument which might be lodged against the argumentation of the previous section: the advocate of nanoethics could concede that it does not raise any numerically distinct issues, but nevertheless could maintain that those concerns are manifest to drastically different degrees through nanotechnology. In this regard, the advocate could maintain that such issues are transformative or revolutionary in some particular way and that, whatever other ethical frameworks we have already developed, those frameworks will be illequipped to deal with the force that nanotechnology represents. So, for example, maybe it is the case that we are already able to hold some informed discussion about the ethical significance of privacy, but it will be the case that nanotechnology will bring about such tremendous effects in this arena that only a radical reconception of privacy and its moral significance would do justice to these effects. If this is true, then it is certainly uncongenial to the overall line that I wish to be defending, so it is worth taking time to extend some consideration to this approach. I will not go through the different issues individually, but rather hope to abstract away the essential structure of this approach and to consider it in that regard. To start, let us think more clearly about the notion of technological progress—or even progress more generally—that could plausibly undergird the claim that a revolution is at hand. For it to be the case that this is possible, it seems to me that at least the following structural features must obtain: first, there has to be some change in some metric across some amount of time; and, second, that change has to be sufficient to warrant a reconception of some basic premises, be they conceptual, normative, or otherwise. The first condition is often and easily met. Consider, for example, the following graph, which plots the world record times for the one mile run since the founding of the International Association of Athletics Federations:27 As this graph clearly shows, the world record times in the one mile run have been progressively falling over the past century. The evolution of those times, as with most real-world phenomena, is uneven, though the trend is unmistakable. Furthermore, the causes for the trend are fairly well-understood: improved training techniques, improved sports medicine, better dietary knowledge, and so on. Has running therefore been revolutionized? I think not, and the reason is that the gains are simply not substantial enough. From the first record (4:14.4 in 1913) to the current (3:43.1 in 1999), there is only a 31.3 second improvement, which is just over 12% faster. Even without a theory about how much improvement is actually needed for a revolution, it seems to me that this clearly cannot meet the threshold. Another point worth making about this sort of trend. First, notice that I have plotted a linear regression on top of the data points, and extended that regression to 2008. It is not likely that anyone will run a 3:37 mile by then, and it is nearly impossible

27

Data taken from Wikipedia (2007). A fantastic book documents the quest to break the four minute mile—achieved when Britain’s Roger Bannister ran 3:59.4 in May of 1954—as well as the subsequent history. See Bascomb (2004).

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that anyone would run a 3:00 mile around 2100—if ever, given the limits of human biology—which is approximately when the regression would predict. The point, then, is that extrapolating into the future from some current or past trend has hazards if those trends will not continue. So, even to establish some future projections based on the above data, we have to have assumptions that transcend the data itself. If nanotechnology does effect some changes in the short- or mid-term, then, it hardly follows that we can extrapolate those changes into the indefinite future and then champion some pending revolution. But, as I have already said, I am otherwise skeptical as to the revolutionary force if the changes are on the above order of magnitude. A more plausible case for a revolution comes when we consider exponential (rather than linear) change. Consider, for example, Moore’s Law, named after Intel co-founder George Moore; this law states that the number of transistors that can fit on an integrated circuit doubles every 2 years.28 When Intel’s first processor, the 4004, was released in 1971, it had 2,300 transistors (Intel Museum, n.d.). As of 2007, its most recent processor, the Dual-Core Intel Itanium 2, has over 1.7 billion transistors (Shiveley, 2006). Those 36 years, then, accommodate just over 19 doublings in transistor capacity, which is extremely close to Moore’s prognostication.29 If this trend were idealized and plotted, it would look like this:30 In this case, the transistor capacity in 2007 is on the order of 100,000,000% greater than the transistor capacity in 1971 (cf., the 12% improvement in running times). So it seems obvious that there have been dramatic changes in computing since the early 1970s, and I suspect that anyone with experience of these older machines would certainly agree. Again, there are concerns about projecting these trends into the future; as pertains to Moore’s Law alone, there is already concern that physical limits will derail the continued rate of increase, though multi-core chips will continue to allow for substantial improvements. Regardless, it seems reasonable to recognize a revolution in computing, as well as to recognize that this revolution will continue (indefinitely) into the future. Returning to nanotechnology, consider the following graph, which takes a similar time span—otherwise chosen arbitrarily—to the processor revolution and shows the same increase during that period: If this were the proper representation of nanotechnology’s promise, then, mutatis mutandis, there would be no choice but to confer the same revolutionary status afforded to processors above. Nevertheless, I think that there are two pressing worries with this approach: empirical/epistemic and conceptual.

28

The doubling time is sometimes mentioned as 18 months, but Moore claimed that it was 2 years. The original paper is Moore (1965). See also Intel’s web site at http://www.intel.com/technology/ mooreslaw/ (accessed August 17, 2007). 29 Mathematically, 2.300 × 219 = 1.2 billion, which is reasonably close to 1.7 billion. Note that the transistors’ capacity, on average, doubles slightly faster than Moore predicted. 30 This representation roughly reflects the actual developments of transistor capacity for Intel processors in the intervening decades as well; the improvements have obviously not come at a constant rate, but are not far from it, either. That history is available at http://www.intel.com/technology/mooreslaw/index.htm (accessed August 17, 2007).

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The empirical challenge is to show that, in fact, nanotechnology has the potential to increase something in some dramatic way. This challenge does not deny that nanotechnology will be used to make lighter and stronger materials, cleaner water, readily available solar energy, and so on. (In fact, it need not concede these claims, either, but certainly need complain about them.) Rather, it is completely consistent with these outcomes that the appropriate graph looks like this: And, as I argued above, it is hardly obvious that this sort of illustration represents a revolution. In addition to these empirical claims, there are the related epistemic ones: to make a claim about the coming revolution requires that we disentangle the hype from the reality of nanotechnology as well as to make longitudinal predictions thereof. To be sure, any coming revolution’s ontology is independent to our forecasting of it, but the present claims about any such revolution must be epistemically well-founded and defended. Second, and perhaps more importantly, I have deep conceptual worries about Fig. 1.3. In particular, note that the y-axis is left undefined. What does the y-axis represent? It is simple to understand the axes in the first Figs. 1.1 and 1.2: they represent time and transistor capacity, respectively. These things are quantifiable— indeed, they are quantities—and can be easily measured. But when we talk about the transformative capacity for nanotechnology, it is far from clear what is being “transformed”. Or at least, in the cases where it is clear what will be affected, it is far from clear that there is any sort of transformation. Consider the tensile strength of materials: nanotechnology will surely lead to improvement in this area. But that improvement undoubtedly has to be more accurately represented by Fig. 1.4 than by Fig. 1.3. For example, some materials fashioned from carbon nanotubes are 250 times stronger than steel, yet one tenth the weight (Johnson, 2005; Florida State University, 2005). This is only an increase in two orders of magnitude for strength

04:14.9

time (minutes:seconds)

04:10.6 04:06.2 04:01.9 03:57.6 03:53.3 03:49.0 03:44.6 03:40.3 03:36.0 1913 1918 1923 1928 1933 1938 1943 1948 1953 1958 1963 1968 1973 1978 1983 1988 1993 1998 2003 2008

year

Fig. 1.1 One mile run world record

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1800

transistors (in millions)

1600 1400 1200 1000 800 600 400 200 0 1971 1973 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007

year

Fig. 1.2 Moore’s law

2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034 2036

year

Fig. 1.3 The nanotechnology revolution

and one for weight, each of which is far from the six-fold increase in transistor capacitor for processors; even if there is nothing special about six-fold increases in particular, they are far greater than the increases in this case. And this example is probably one of the more dramatic that nanotechnology can offer (in terms of scales); other applications will yield substantially lower improvements. As claims become more grand, it is less clear what they actually mean. Consider, for example, the first tenet of the “Transhumanist Declaration”:

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2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034 2036

Fig. 1.4 The nanotechnology revolution?

Humanity will be radically changed by technology in the future. We foresee the feasibility of redesigning the human condition, including such parameters as the inevitability of aging, limitations on human and artificial intellects, unchosen psychology, suffering, and our confinement to the planet earth. (World Transhumanist Association, 2002)

Returning to Fig. 1.3, how are we supposed to conceptualize such claims on the y-axis of our graph? To be sure, the transhumanist might reject the challenge, but I think it is a reasonable one: we are trying to show what is being transformed by technology.31 Presumably this would be such a complex battery of goods as to make the aggregation impossible, or else it would be some concept—such as “human potential” (Bostrom, n.d.) or the “human transcendence of biology”32—that is barely intelligible. Relatedly, as the claims become more grand, they become less empirically plausible (or, at least, less popular). Consider, for example, claims that nanotechnology could offer the cure to aging (Sethe, 2007) or be the means by which to effect wide-scale space exploration (Toth-Fejel and Dodsworth, 2007); these are not ideas that are without their merits, but also not the ones that many talented research scientists are rushing to pursue. At any rate, my present interest is not with any program in particular—indeed, many of the above are important projects pursued by friends—but rather with precise claims about why nanotechnology (or any other technology) deserves revolutionary status. As I laid out the challenge earlier in this section, it both must be the case that there is some change in some metric across some amount of time

31

It is worth noticing that this sort of project does not afford a privileged status to nanotechnology, but rather to all technologies: nanotechnology, biotechnology, informational technologies, computer technologies and artificial intelligence, and so on. As the purview for the project broadens, nanotechnology’s role with in it similarly diminishes. 32 See, for example, Kurzweil (2006). Another ambitious project is Hughes (2004).

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and that such change has to be sufficient to warrant a reconception of some basic premises, be they conceptual, normative, or otherwise. There is no doubt that nanotechnology satisfies this first requirement but, to my mind, there is sufficient doubt as to whether it satisfies the second. As a final example, return to nanotechnology and aging and imagine that life expectancy doubled (note that doubling is far closer to Fig.1.4 than to Fig. 1.3). Now there would be many additional things to worry about, such as overpopulation and its effects on food, water, living space, economies, and so on. It would still be the case that happiness and autonomy matter, and no number of people in the world can change those basic ethical precepts. As I repeated throughout Section 1.5, we will continue to have new empirical inputs into our ethical frameworks, but those frameworks themselves will be left unaffected.

1.7

What’s Different?

In Section 1.4, I presented many of the issues that are discussed under the aegis of nanoethics. Then, in Sections 1.5 and 1.6, I argued that none of these issues is novel in any substantive way or degree. Those issues need to be evaluated in the context of nanotechnology, but the moral issues are not unique to it. In this regard, I think that there is a plausible contrast between nanoethics and other disciplines within applied ethics: other applied ethics can reasonably be thought to instantiate novel ethical worries in ways that nanotechnology does not. I will explore the implications of this claim in Section 1.8 but, for now, I want to try to defend it. I should say, from the outset, that I think the claim is false, but I nevertheless find it at least plausible. My ultimate skepticism is not likely to be shared by many other people, though I will try to advance the strongest versions of the arguments that I expect they would make. Furthermore, for present purposes, the skepticism is irrelevant, though it otherwise ties into a broader project about the relationship among applied ethics. Finally, as we will see in Section 1.8, I think that such skepticism is less problematic than might otherwise be thought. So, for now, the goal is to try to establish that other applied ethics might have distinguishing moral features and, if they do, then this sets them apart from nanotechnology. There are lots of different disciplines within applied ethics, and I cannot hope to cover them all. Nevertheless, let me comment on the following, which are either chosen for their traditions or else have other instructive features: biomedical ethics; business ethics; environmental ethics; and neuroethics. Again, the point is not to have comprehensive analyses of these disciplines, but rather to try to motivate a line which sets them apart from nanoethics.

1.7.1

Biomedical Ethics

In a seminal work, Edmund Pellegrino and David Thomasma (1993; see also Pellegrino, 1985) write this about medicine:

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F. Allhoff Let us step back…for a moment and see why medicine cannot escape being a moral community. Three things about medicine as a human activity make it a moral enterprise that imposes collective responsibilities of great moment on its practitioners: (1) the nature of illness; (2) the nonproprietary nature of medical knowledge; and (3) the nature and circumstances of a professional oath.

Regarding the nature of illness, they think that the sick are in uniquely dependent, anxious, vulnerable, and exploitable states; they must “bare their weaknesses, compromise their dignity, and reveal intimacies of body and mind (Pellegrino and Thomasma, 1993).” Relatedly, trust is critical in the relationship between patient and physician. Regarding (2), the physician’s knowledge is acquired “through the privilege of medical education…and is permitted free access to all of the world’s medical knowledge” (Pellegrino and Thomasma, 1993, p.36). And, finally, physicians take oaths which bind them to their communities, to their patients, and which transcend self-interest and create moral duties. Whether we agree with Pellegrino and Thomasma’s vision of medicine is less important than the fact that they can even advance the claims that they do; such claims would not even seem coherent when talking about nanotechnology. Starting with (1), I am not sure that illness is necessarily as compromising as Pellegrino and Thomasma suggest, but it surely enjoys a different moral status than, say, nanocircuitry. The latter need not have anything to do with a moral agent at all, whereas the former analytically has to. Regarding (2), much of nanotechnology is precisely proprietary, and nanotechnologists are quite interested in ensuring that this stays the case. To be sure, there are non-proprietary aspects of nanotechnology (e.g., basic physics) and there are proprietary elements of medicine (e.g., patented drugs), but the former surely lacks the community and history of the latter. Regarding (3), there are no codes of ethics in nanotechnology, though there are various movements to create them (Shew, 2008; see also Institute for Food and Agricultural Standards, 2007). Such codes, though, speak more to safety of the technological processes than to moral obligations to help the sick or to serve any other community good. I think that the case for medicine is overstated, particularly if we think of things like flu shots and sprained wrists: rich moral notions like vulnerability and sacred trust seem attenuated in these contexts.33 Nevertheless, there is something compelling about this account, and the biomedical ethics literature clearly reflects a sense that there is something morally special about medicine. Other fields (e.g., law) might have some of these features (e.g., (3) ), but, even if we do not offer some high privilege to illness, it is hard to see how they would have all three of the features. Granted, we could jettison this conception of medicine but, as I said in the introduction to this section, the idea is only to make plausible the idea that some applied ethics are ethically unique, and I think that medicine can readily sustain this weak aspiration.

33

For a more sustained critique of some of these ideas, see Allhoff (2006) especially pp. 395–400.

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29

Business Ethics

Consider a classic debate in business ethics, which positions Milton Friedman against R. Edward Freeman about corporate social responsibility. At stake is whether corporations have any obligations other than to increase their profits, whether social, environmental, or otherwise. Friedman argues that they do not, and that any attempt by corporations to do so, absent the will of the shareholders, is an unjust exercise of executive power and, furthermore, one that is not likely to be successful regardless (as such ventures fall outside the executives’ expertise) (Friedman, 1970). Freeman, by contrast, argues that the corporation has duties to all of its stakeholders, among which he counts all those (including shareholders) that are affected by the activities of the corporation: employees, consumers, suppliers, community members, and so on (Freeman, 1994; see also Freeman, 1984). Arguably, this disagreement forms the central debate in business ethics, from which other issues all follow (Allhoff and Vaidya, in press). Consider, for example, worker safety: absent any (direct) obligations to the worker, corporations might only provide for worker safety if, ultimately, it maximized profits (e.g., through the avoidance of lawsuits); similar stories could be told about whistleblowing (cf., duties to consumers), bluffing (cf., duties to suppliers), and so on. In this sense, business ethics is unified in such a way that nanoethics clearly is not. Furthermore, business ethics is then predicated upon a single ethical construct, which is rarely realized in other contexts: that of fiduciary obligation. To wit, the executive of the corporation has been entrusted to his post by a majority of the shareholders, and the principal question is whether his obligations are solely to them or rather whether those obligations extend elsewhere. It seems to me that this issue has to be endemic to business ethics, at least insofar as, a fortiori, it is the only area in which we have executives. It turns up in some other guises elsewhere, such as law (or medicine [Allhoff, 2008]): consider whether the criminal defense attorney has obligations only to her client or whether she also has duties to the justice system (Freedman, 1966). Structurally, this might look the same but, to the extent that it does, it seems to me that the central features are being exported from the business ethics context rather than vice versa. Regardless, law (or medicine) is often treated as “professional ethics” closely aligned with business ethics (Allhoff and Vaidya, in press). Therefore, I do not think that the existence of these other applications challenge the independence of the shareholder/stakeholder debate in business ethics.

1.7.3

Environmental Ethics

Next, consider environmental ethics, which raises deep concerns about the limitations of economic cost-benefit analysis. In a seminal paper, Mark Sagoff writes about the outrage that the citizens of Lewiston, New York who live near the radioactive

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waste disposal that was borne from the Manhattan Project. Despite assurances from the local governments that there are no associative health risks, the citizens simply do not want to live near such waste because it conflicts with values that they have (Sagoff, 1981). Assuming for the moment that there really are no hazards from such waste, which seems a dubious assumption, it seems that traditional economic analysis cannot accommodate whatever considerations are due those citizens. The reason is that, ex hypothesi, there are not any (economic) costs; rather the costs have to do with senses of justice, propriety, and so on. To be sure, there are sophisticated approaches to cost-benefit analysis that try to accommodate these features (Shrader-Frechette, 1998), but there is at least a prima facie problem for the approach. Another example might be the value of the redwoods in California (or any other sort of environmental preservation project); the cost-benefit analysis system would hold that those redwoods are worth whatever people are willing to pay to not have them cut down.34 If the revenues from the Redwood National and State Parks are less than what Disney is willing to pay—by which there are obvious extensions to what consumers are willing to pay—for a theme park, then it is Pareto suboptimal to maintain the trees to the exclusion of a theme park. In either of these cases, economic analyses seem to miss the point, which is that there are relevant extra-economic values. In their more extreme formulations, the economic approaches could unequivocally deny that any other such values matter and, in their less aggressive versions, they might try to cache out those “extra”economic values economically. Regardless, environmental ethics stands at a pivotal place in this debate; much of resultant framework has been developed precisely in environmental contexts. To be sure, there are other contexts in which it might be investigated: consider torts liability reform in medicine where, despite economic inefficiency, some commentators nevertheless oppose such reform on the grounds that (extremely high) punitive damages are sometimes justified by the merits of evincing our moral disapprobation (Edwards and Cheney, 2004). But, again, this is a debate that was largely carried out in the environmental ethics literature, and which forms a cornerstone of that field. Nanotechnology lacks such a distinctive feature, whether in its own regard or whether one for which it has—or will, the former might be unfair given its incipience—catalyzed important investigations.

1.7.4

Neuroethics

Finally, consider neuroethics. This is a newer field, but one that is worth discussing because of various similarities that it has with nanoethics. Again, it is

34

For a recent discussion of cost-benefit analysis in the US that contrasts its use with the “precautionary principle” of the UK, see Sunstein (2005).

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new, like nanoethics. Also, it is heavily predicated upon technology, unlike the disciplines described above. While much of the current literature focuses on the ethical issues in functional neuroimaging, the field will surely expand to include brain implants (some of which will be enabled by nanotechnology), psychopharmacology, and so on. Advocates of neuroethics certainly think that a lot is at stake with these new technologies. For example, Judy Illes and Eric Racine write that neurotechnology “will fundamentally alter the dynamic between personal identity, responsibility, and free will…Indeed, neurotechnologies as a whole are challenging our sense of personhood and providing new tools for society for judging it” (Illes and Racine, 2005). Some neuroscientists even think that neuroscience will annihilate the concept of personhood altogether (Illes and Racine, 2005). I think that there are lots of reasons to be skeptical about these claims (Buford and Allhoff, 2005; Buford and Allhoff, 2007), but, for now, let us take them seriously. Personhood, given its associative relations to moral responsibility, is a foundational concept in ethics. Neuroscience, ex hypothesi, is the field that is most qualified to elucidate the workings of the brain and, with them, the psychological (if not conceptual) underpinnings for personhood.35 If, for whatever reasons, neuroscience can cast doubt upon the coherence of this concept, then that would have deep ramifications for ethics. Relatedly, neuroscience might have something direct to say about moral responsibility: perhaps it can somehow vindicate determinism, or else provide evidence in favor of free will (Freeman et al., 2000). Again, I have deep skepticism about these projects; it seems to me that they are predominantly philosophical ones to which neuroscience is largely irrelevant. Nevertheless, there is a burgeoning enterprise in these topics, and I trust that there are at least some issues worth talking about, even if the conclusions turn out to be negative. Regardless of whether the project fails or succeeds, neuroscience is the only (non-philosophical) discipline that can even hope to make headway on these questions which, again, are foundational to ethics. If neuroethics is understood to encompass the implications that neuroscience has for ethics or else the proper ethical stance to take on various practices within neuroscience—it seems to me that it could be understood in both these ways—then this discourse really does offer something new that is not already instantiated in different applied ethics. And, furthermore, this is not just to say that neuroethics is different in the trivial sense that it takes a unique target (viz., neuroscience), but rather that such a target really might concern itself with ethical and metaphysical issues for which it is specially positioned to render commentary.

35

The link between personhood, personal identity, and psychological criteria invites a long tradition which extends, at least, to Locke (1994). More recently, see Parfit (1984). For a dissent—one which postulates biological, as opposed to psychological criteria—see Olson (1997).

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1.8

F. Allhoff

What Now?

In this paper, I have taken a fairly negative line toward nanoethics. In Section 1.5, I argued that there are not new issues in nanoethics and, in Section 1.6, I argued that those issues are not manifest to dramatically different degrees. In Section 1.7, I argued that nanoethics therefore failed to demonstrate features which are (at least plausibly) instantiated in other disciplines within applied ethics. So if there is nothing new or dramatic in nanoethics, and if something new or dramatic is, in fact, what defines and individuates different applied ethics, what are we to make of nanoethics? I have already expressed skepticism about this latter criterion and, in this final section, I will press that skepticism. Absent such a requirement, there will still be a space for nanoethics, and it is that space that I want to articulate. To motivate the line that I am going to take, consider an argument made by David Luban in a classic essay about the adversarial legal system (Luban, 1983). In this essay, Luban explores the ethical justification for the adversarial legal system (e.g., as it exists in the US) wherein plaintiffs and defendants are each afforded a legal team; these legal teams then compete against each other such that one wins and one loses. Ethically, the worry about such a system is that the priority is placed upon winning as opposed to reaching just outcomes (e.g., that the guilty are convicted and the innocent are exonerated). And, in the course of trying to win, lawyers might engage in behaviors that range from the morally contentious to the downright immoral (cf. Freedman, 1966). Luban wonders what sorts of considerations could justify this system, as against some alternative (e.g., the European inquisitorial system) that would avoid these hazards. Ultimately, his conclusion is that the best defense of the system that can be provided is a pragmatic one, which holds that the system is probably as good as any other (despite the hazards, it also has benefits, such as the double-edged zealous advocacy) and that changing systems would not be worth the trouble. Whatever the merits of this analysis, I think that it introduces an interesting distinction which can be applied to present purposes, though the analogy is otherwise quite loose. In particular, there are two different sorts of (ethical) justifications that we might offer for something, be it an institution, practice, or discipline. The first is metaphysical, by which I mean that there is some moral feature that can be appealed to in order to make the appropriate justification. Furthermore, I take it that the metaphysical justification will only go through if the moral feature uniquely (or near-uniquely) attaches to the justificatory target. If it does not, then it is not that target which is being justified, but rather some broader one and the target then only becomes derivatively justified given its relation to the broader one. Alternatively, something might have a pragmatic justification which is weaker than the metaphysical justification; by this I mean that metaphysical justifications are necessary, whereas pragmatic justifications are contingent upon various empirical circumstances. So, for example, the adversary legal system would cease to be

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justified given its pragmatic justification if circumstances changed such that implementing a new system just was not that difficult. However, if such a system had a metaphysical justification—imagine that it were (necessarily) the morally best system—then that justification would persist independently of vagaries in circumstance. Returning now to applied ethics, the disciplines discussed in Section 1.7 have plausible claims to metaphysical justifications. Biomedical ethics is uniquely concerned with illness and the associative vulnerabilities and anxieties that it engenders. Business ethics critically addresses the nature of fiduciary obligation, as well as the related ethical issues that therein follow. Environmental ethics challenges costbenefit analyses and might generate alternative deliberative frameworks. Neuroethics aspires to various debates within personhood, moral responsibility, and free will. So I think that it is plausible to think that these fields are metaphysically justified insofar as they pick out ethical features that are endemic to them. To be sure, I expressed skepticism in that section about many of these claims, and it might turn out that none of these disciplines actually is metaphysically justified. Nothing hangs on that, though, as the point was just to show that nanotechnology cannot even plausibly make such claims; if it turns out there is only pragmatic justification to go around, my arguments would be no worse off. (In fact, I think that this is the case, but I will not further explore that line here.) Coupling the notion of metaphysical justification with the argumentation of Section 1.5, it should now be clear that I do not think that nanoethics has such a justification. However, in light of the distinction between metaphysical and pragmatic justification, the lack of metaphysical justification need not be fatal for nanoethics. Rather, we can justify nanoethics pragmatically. Let me conclude this paper by characterizing that pragmatic justification. And, insodoing, I hope that we see what sort of response should be extended to nanoethics’ skeptics (Keiper, 2007), even if this paper were largely conceived as a response to its advocates. My own stance, then, is therefore somewhere between these two poles. The locus of the pragmatic justification centers around the impacts that nanotechnology will have on society. As discussed in Section 1.4, these impacts are likely to be multiple, and there are ethical issues (identified in that section and in Section 1.5) that must be addressed. As it turns out, those ethical issues are not tremendously novel, though they will have be addressed within a new context. But, just because they are not novel, it hardly follows that they do not need to be addressed at all and that we can just proceed with ethical disregard. Rather, the technologies must be evaluated along whatever ethical dimensions they manifest effects, whether well-being, rights and liberties, fairness, or whatever. So, ultimately, I think that this is the right way to look at nanoethics. Nanotechnology deserves ethical attention. We need to be cognizant about the ethical impacts that nanotechnology will have, and we need to develop our empirical knowledge of the science such that those impacts can be well-understood. As I have argued in this paper, I do not think that we need an autonomous applied ethic to study these questions, but that, ultimately, makes the questions no less important.

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References Allhoff, F. (Ed.), 2008. Physicians at War: The Dual-Loyalties Challenge. (Dordrecht: Springer). Allhoff, F. 2005. On economic justifications of bioterrorism defense spending. American Journal of Bioethics, 5.4, 52–54. Allhoff, F. 2005. Germ-line genetic enhancements and Rawlsian primary goods. Kennedy Institute of Ethics Journal, 15.1, 39–56. Allhoff, F. 2006. Physician involvement in hostile interrogations. Cambridge Quarterly of Healthcare Ethics, 15, 392–402. Allhoff, F. and Lin, P. 2006. What’s so special about nanotechnology and nanoethics? International Journal of Applied Philosophy, 20.2, 179–90. Allhoff, F. and Vaidya, A. J. (Eds.) (in press). Business Ethics. (Calgary: Broadview Press). Allhoff, F. and Vaidya, A. J. (Eds.) (in press). Professional Ethics. (Calgary: Broadview Press). Allhoff, F., Lin, P. and Moore, D. 2009. Nanotechnology: What It is and Why It Matters. (Malden, MA: Wiley-Blackwell). Allhoff, F., Lin, P, Moor, J. and Weckert, J. (Eds.) 2007. Nanoethics: The Social and Ethical Implications of Nanotechnology. (Hoboken, NJ: Wiley). Allhoff, F., Lin, P., and Weckert, J. (under review). Nanoethics, privacy, and trust: The impact of monitoring and surveillance devices enabled by nanotechnology. National Science Foundation (US). American Bar Association. 2006. Tort law: Asbestos litigation. Retrieved August 13, 2007, from http://www.abanet.org/poladv/priorities/asbestos.html. Baird, D. and Vogt, T. 2004. Societal and ethical interactions with nanotechnology (“SEIN”): An introduction. Nanotechnology Law and Business, 1.4, 391–396. Bascomb, N. 2004. The Perfect Mile: Three Athletes, One Goal, and Less than Four Minutes to Achieve It. (Boston: Houghton Mifflin). Bawa, R. and Johnson, S. 2008. Emerging issues in nanomedicine and ethics. (In F. Allhoff and P. Lin [Eds.], Nanoethics: Emerging Debates. Dordrecht: Springer). Berube, D. M. 2008. Intuitive toxicology: The public perception of nanoscience. (In F. Allhoff and P. Lin [Eds.], Nanoethics: Emerging Debates. Dordrecht: Springer). Bodansky, D. 1991. Scientific uncertainty and the precautionary principle. Environment, 33.7, 4– 5, 43–44. Bostrom, N. (n.d.). Transhumanist values. Retrieved August 23, 2007, from http://www.nickbostrom. com/ethics/values.html. Brandt, E. and Otter, C. L. 2005. Preserving the foundation of liberty. Notre Dame Journal of Law Ethics, and Public Policy, 19.1, 261–276 Buford, C and Allhoff, F. 2005. Neuroscience and metaphysics. American Journal of Bioethics, 5.2, 34–36. Buford, C. and Allhoff, F. 2007. Neuroscience and metaphysics (redux). American Journal of Bioethics (AJOB-Neuroscience), 7.1, 58–60. Cantrell, M. K. 1998–1999. International response to dolly: Will scientific freedom get sheared? Journal of Law and Health, 13, 69–102. Chicken, J. C., Telford, T., and Posner, T. 1998. The Philosophy of Risk. (Reston, VA: American Society of Civil Engineers). Cross, F. B. 1996. Paradoxical perils of the precautionary principle. Washington and Lee Law Review, 53, 851–921. de Gonzalez, A. B. and Darby, S. 2004. Risk of cancer from diagnostic x-rays: Estimates for the UK and 14 other countries. Lancet, 363.906, January 31, 345. DeCew, J. W. 1997. In Pursuit of Privacy: Law, Ethics, and the Rise of Technology. (Ithaca, NY: Cornell University Press). Ebbesen, M. and Jensen, T. G. 2006. Nanomedicine: techniques, potentials, and ethical implications. Journal of Biomedicine and Biotechnology, 1–11.

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Chapter 2

The Presumptive Case for Nanotechnology1 Paul B. Thompson

2.1

Introduction

The United States 21st Century Nanotechnology R&D Act of 2003 simultaneously directs Federal agencies to undertake research and planning activities that will promote the development of nanoscale science and technology, while also mandating consideration of Societal and Ethical Implications of Nanotechnology (SEIN). The case for nanotechnology is implicit in the first component of this directive, and it is simple and direct. The tools and science we call nanotechnology can be employed to increase economic productivity, reduce negative environmental impacts, and to insure and improve human health. The record of products already on the market is mixed: nanoparticles in sunscreens may pose risks that have escaped the scrutiny of regulatory oversight, and who really cares about “nanopants” in any case? At the same time, less publicly visible nanotechnologies have been utilized in catalysis and packaging for many years with a record of solid (if unspectacular) success. A strong defense of nanotechnology’s ability to deliver on broader criteria of social benefit has been mounted elsewhere. David Berube’s book Nanohype documents a plethora of government and business prognostications that have been produced to promote the possibilities of nanotechnology (Berube, 2006). Products currently under development and promised to do wonderful things, and there are undoubtedly many more applications that are as yet undeveloped, unresearched and even unimagined. On the other hand, Berube also documents a number of cautionary studies that indicate the need to study social and ethical issues in nanotechnology. The rationale for these studies often cites public opposition to so-called GMOs (genetically modified organisms) or to nuclear power. Berube’s analysis suggests that the basis of this opposition lies in a generalized disenchantment with technology and modern life. When mobilized by media coverage and by the feeling that public interests have been neglected in key decision making processes, this disenchantment spawns

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resentment, public demonstrations and organized opposition in the form of publicity campaigns, lawsuits and regulatory activism (Berube, 2006). In the case of GMOs, public outrage has coalesced into a global social movement dedicated to blocking the application of biotechnologies in all but the most compelling biomedical applications (Gaskell and Bauer, 2002). Should SEIN studies adopt the optimism of nanohype? Or should they proceed from philosophical premises that question the value or legitimacy of technology outright? This essay argues that the former approach is more defensible than the latter, but also that taking this perspective leads naturally to an ethical analysis focused largely on possible problems with nanotechnology. The possibility of producing desirable and beneficial environmental outcomes and improvements in human (and animal) well-being provides the basis of an argument for developing and deploying specific products of nanotechnology. That such beneficial products exist or can be conceived is a reason for developing the tools and techniques of nanoscience, but we should not regard such reasons as a sufficient rationale nanotechnology. Indeed, I will argue that the true philosophical significance of these examples and projected benefits lies in the framing for a more detailed discussion of nanotechnology, which should focus on the question, “Why not?”

2.2

The Logic of the Presumptive Case

To say that there is a presumptive case in favor of nanotechnology means that the burden of proof falls on the side of providing reasons to restrict, control, limit, regulate, or moderate the use of the technology, rather than the reverse. It is a “soft” argument in that it proffers reasons that buffer and support a favorable view of nanoscience innovations, and it is not specifically focused on enhancement. Philosophical, rhetorical, methodological and practical reasons conspire in forming the presumptive case. It is intended to establish a framework for ethical evaluations, and for burdens of proof, rather than a knockdown argument favoring any and all applications of nanotechnology. While none of the reasons adduced in developing the presumptive case provide a singularly adequate argument, the fact that each is made on independent grounds means that they are additively persuasive for the purposes of establishing further burdens of proof. Why establish the burden of proof in terms that favor nanotechnology? Logic permits only three options here. In addition to the presumption for nanotechnology, there is its opposite—a presumption against it that demands argument to justify its pursuit—and a third choice that demands case by case evaluation for every proposed use of technology. While this third choice may seem appealing at first blush, it becomes surprisingly difficult to apply in practice. Putatively neutral caseby-case evaluation of technology (like any proposal for case-by-case evaluation of alternatives) actually imposes intolerable costs on our decision making. There is no area of life in which we weigh every possible option on a case-by-case basis, and we would clearly spend all our time weighing and deliberating if we did. Instead

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we rely on “filters” to determine which cases demand more careful scrutiny and deliberation. Such filters often take the form of biases that implicitly structure the burdens of proof that we impose on others and ourselves. Although we can certainly review and rethink when faced with any given case, the idea that we will thoroughly consider every possibility is not really a viable one. The question can thus be limited to two cases: should our cognitive filters be set for or against technology? An argument intended to reset the filters of the people that Berube describes as being resolutely opposed to modern technology would have a different shape from the one that I will develop in this essay, where I will not discuss Heidegger or disenchantment with processes of modernization or global change. Nevertheless, it is useful for everyone to admit that bias exists, that it is not all bad, and that having one’s cognitive filters set in a particular direction does establish an ethical responsibility to test one’s bias from time to time. Having a bias in this sense means that we are predisposed to regard situations and proposals in a given way. People tend to assume that unless some contradictory evidence is presented, or unless reasons for thinking otherwise are apparent, a habitual practice or a standard operating procedure (SOP) is adequate. Being predisposed this way does not mean that there are no considerations that can overturn our inclinations, but it does mean that our evaluation of situations and proposals has an implicit logical structure: unless there is evidence or reason to behave differently, we are inclined to act in the manner in which we are predisposed. Acting ethically then requires that we give due consideration to the evidence and reasons that could contravene our inclinations. A broad set of philosophical considerations in support of a presumption favoring any new technology can be derived from the confluence of utilitarian and libertarian philosophy, as discussed at some length in my book Food Biotechnology in Ethical Perspective (Thompson, 2007). A succinct summary of that rationale goes as follows. If we are inclined to favor human freedom on libertarian grounds, we should allow technology developers to exercise their freedom to develop technology. The history of technologies that have increased the efficiency of our ability get things we want in exchange for a given expenditure of resources and effort suggests that the utilitarian maxim to promote the greatest good for the greatest number would also support technological innovation. Both libertarian and utilitarian rationales come with qualifications and possible concerns but nonetheless, this confluence of rationales means that we begin with a broad philosophical mandate for viewing technological innovation favorably. Critics such as Jeffrey Burkhardt (2001) and Robert Zimdahl (2006) have argued that current scientific culture disinclines bench researchers from undertaking the reflective evaluation needed for new technology to realize its promise. They suggest that scientists are unlikely to be very attentive to qualifications and possible concerns. But the broad mandate we derive from utilitarian and libertarian philosophy can be further strengthened with respect to nanotechnology because the uncritical cognitive filters within science are to a considerable degree counteracted by social and governmental filters (that is, institutions) that weed out a lot of bad ideas without our having to pay much attention to them. A scientist who has a “great idea” for nano-encapsulated rutabaga-flavored chewing gum except for that unfortunate

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side-effect (people who chew it break out in an uncomfortable rash) will not get far in the real world of food technology. The mere fact that most products won’t be developed unless there is a chance of making money from them weeds out lots of bad ideas, though unfortunately, as has been the case with GMOs, some good ones as well (see Thompson, 2007). The market is a filter. Environmental protection and food safety agencies within government provide additional filters. The threat of a liability lawsuit may be the ultimate filter for many individuals and firms that contemplate introducing new technology. An awful lot of the bad ideas in nanotechnology will be eliminated from consideration whether working scientists or ordinary citizens adopt an ethical predisposition against food biotechnology, or not. These economic, regulatory and tort-based legal filters are a part of the SOP for new technologies. Of course it is possible that these institutions have gone awry, so noting them is not to say that they are working perfectly. Nevertheless, the belief that our society is institutionally oriented to the promotion of certain technologies rather than others must be tempered by the recognition that any technology faces a significant set of hurdles as a matter of course. Thus, the weak presumptive case from political philosophy is strengthened by economic and legal institutions that govern nanotechnology, but there is more. Given the range of potential beneficial applications for nanotechnology, one would expect that many cases will be presented for our consideration. Given the economic and regulatory filters that are already in play, many applications will never see the light of day as practical technologies. It is thus reasonable to expect that applications of nanotechnology able to work their way through the economic and legal filters described above will be favorable more frequently than they are unfavorable. There is thus a purely methodological reason to adopt a presumptive view favoring nanotechnology: our cognitive filters should be on the alert for bad outcomes and products, rather than the reverse. It is thus entirely appropriate that philosophers spend most of their time worrying about how nanotechnology can go wrong. This reasoning may sound contrary to technology boosters and latter-day Luddites alike. If they are for nanotechnology, why are philosophers spending all this time on problems? Or contrarily, if we are concerned about problems, why do we adopt an outlook presuming that nanotechnology will be good? The answers to these two questions (like the questions themselves) may seem to run at cross purposes. Conducting a due and careful ethical evaluation of any given technological product or group of technological methods requires weighing the good and the bad, as all proponents and opponents of the technology must admit. A truly neutral view of technologies, I have argued, is a seductive illusion. If we presume against, we demand that advocates for overcome our bias by presenting arguments in favor of a specific application. What we would get is an endless, repetitious and ultimately numbing recital of benefits, much on the order of those recited in David Berube’s summary of nanohype. It is thus methodologically much more effective to simply assume that there will be benefits from those products or applications that work their way through institutional filters, and then to give due consideration and review to the possible problems or objections. Proponents of technology spend a lot of time in the public arena extolling its benefits and combating its critics. It is thus,

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perhaps, natural for them to see philosophers who proposes to discuss ethical problems with nanotechnology as an ally of the critics, so it is reasonable and appropriate for philosophers to begin the discussion by not only taking the likelihood of benefits as a methodological starting point, but also by making an explicit and detailed statement of the way that likely benefits provide a presumptive bias for favoring nanotechnology. This is, of course, what this essay is all about. An answer to the neo-Luddites (I am using the term affectionately) also notes that review of negatives is logically and conceptually more effective when done against the background of presumed benefits. To readers skeptical of nanotechnology, I also repeat again that an argument engaging the extensive philosophical and social criticism of technology that has taken place over the last 200 years would have a very different structure and approach than the presumptive case for nanotechnology. Nevertheless, while expressing some sympathy for the line of criticism that has produced sophisticated critiques of technology such as those by Albert Borgmann (1983, 1999) or Andrew Feenberg (1991, 1999), I must insist that the methodological reasons for developing an ethical review of any particular technological domain by taking the likely beneficial outcomes of developing that domain for granted are sound. Indeed, the work of Borgmann and Feenberg points us toward a hard look at specific tools and techniques, and that look will be more focused and penetrating if we concentrate on those applications where we think there may be trouble. Finally, it is a social fact that a strong presumptive case in favor of technology still exists within industrialized and industrializing economies. Late twentieth century culture is organized such that people expect change, and even if they do not expect it to be as uniformly beneficial as they once did, the traditional, static social structures, with their rigid social hierarchies and their lack of social mobility, are a thing of the distant past. This social fact may imply that most individuals in late twentieth century society are inclined to favor technological change, but even if it does not, it shows that establishing a moral presumptive case against any broad form of technology will be very costly. It will be the life’s work many dedicated people, and they will have to be very persuasive. Furthermore, it will compete with other large social issues such as opposition to racism and gender bias, as well as environmentalism and world peace. As such, the case against nanotechnology needs to be pretty compelling to justify a social movement to reverse the status quo. If the case against this new technology is, in other respects, a close call (and the list of potential benefits from nanotechnology already cited is a reason to think that it is), the sheer costliness of campaigning against it tips the deck in its favor. Elsewhere I have argued that the campaign against agricultural biotechnology has been too costly for environmentalists and supporters of social justice (Thompson, 2003a). The people who have dedicated themselves to opposing agricultural biotechnology would have better expended their time and energy on more pressing issues in the food system. This, however, is not the place to pursue that theme. One would expect that nanotechnology’s boosters will be pleased with this starting point, but the logic of the presumptive case for nanotechnology does have implications that are the frequent subject of complaint from that quarter.

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Both boosters and more neutral or objective scientists have been heard to complain that talk of “ethics” is too frequently critical. Why is there not an ethical argument for technology, they say? Well, they have a point, of course, and one purpose of this chapter is to acknowledge it. Yet the point bears repeating: if one presumes in favor of biotechnology, then most of work in conducting an ethical analysis will consist in entertaining the objections to that premise. This means that most of what one says on the ethics of nanotechnology is a review of reasons to oppose, qualify or constrain the technology. Ironically, it is the strong presumptive case for nanotechnology that will lead ethicists to concentrate their first round of analysis on negatives, on reasons to resist and oppose. In many instances, the presumption for technology survives attack unscathed. In a few cases, it must be modified or constrained. The best case for nanotechnology is the one that takes the reasons against it most seriously. That is the thesis of the presumptive case.

2.3

Making the Case for Nanotechnology Badly

Unfortunately, many of the attempts to recite a case for biotechnology and GMOs were unconvincing even to mildly critical ears. Sometimes the problem is simply a lack of sophistication or a poor choice of words. During the first half of the 1980s, scientists, venture capitalists and university fund-raisers became highly practiced at making the case for both food and medical biotechnology in economic terms. They convinced funding agencies, administrators, state governments and private investors to place large sums of money at their disposal on promises of impressive financial returns and great wealth for all (Teitelman, 1989). Some of the ethical fallout from those promises is discussed in my book (Thompson, 2007), but what is significant here is that biotechnology’s boosters became habituated to making their case in terms of economic gain. Biotechnology was good because it was going to make everyone (or everyone who got on board soon enough) very rich. Needless to say, this is not a compelling ethical argument for biotechnology or nanotechnology. Although the importance of economic returns and benefits should not be underestimated in ethical assessments, too much of the “case for biotechnology” consisted only in economic boosterism and whining about the negativism of the critics. Biotechnology’s boosters did even more serious damage to their own case by offering several singularly bad arguments. The balance of this chapter will take on four bad arguments that seem to have many proponents among the scientists and decision makers who were involved in the development of GMOs. They are presented here as object lessons for how not to argue for nanotechnology, as well as to dissociate such fallacious reasoning from the presumptive case that I have outlined above. The first of these appeals to an outdated and naive notion of technological progress, and will be called the Modernist Fallacy. The second fallacy assumed an inappropriate reference group for making comparisons about the relative risks of genetic engineering, and the error will be equally tempting for boosters of nanotechnology. It is a version of the Naturalistic Fallacy, the common moral

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mistake of claiming that because something is natural, it is therefore good. The third fallacy also addresses risks of technology and is an instance of the Argument from Ignorance. The final argument emphasizing world hunger may have been more particular to GMOs than to many of the applications foreseen for nanoscience, yet it is worth considering as an example of how even legitimate benefits from technology can be overplayed by advocates. The first three bad arguments are examples of fallacious reasoning that one hears repeatedly at scientific meetings, both from the podium and over coffee. Anyone who has been present at such meetings has heard them, and it serves no positive purpose to single out any particular individual for attribution. Casual conversation is not a propitious setting for the production of an informed and rigorous ethical argument; however it is quite likely that most of the people offering these arguments actually believe that what they are saying is establishing an important point about the ethics of food biotechnology. The following criticisms are offered in the spirit of improving the quality of debate, rather than embarrassing individuals who may hold these views.

2.4

The Modernist Fallacy

One easy way to dismiss any and all ethical concerns that might be raised about virtually anything is the reply “That’s progress.” Advocates of nanotechnology have not resisted the temptation to deploy this reasoning, if it can actually be called reasoning by any decent standard. The universal applicability of this strategy is a good reason for giving it a harder look. Other similarly universal replies to criticism (“That’s politics” or “That’s life.”) signal one’s reluctance to discuss the matter further without also conveying one’s moral approval of the state of affairs. “That’s progress” implies that whatever ethical concerns or consequences have just been brought forward, they are the price that must be paid for progressive social change. Now, it may be correct to conclude that some social, animal, environmental or even human costs are a price that must be paid for ethically compelling reasons. If so, it is important to state those reasons and to justify the need to accept certain costs in order to achieve them. If a new rice or potato variety really does end hunger in a region of resource poor farmers that result may indeed be worth some loss of local cultural institutions. If nanosensors for detecting pathogens decrease the risk of food or airborne disease significantly, it may indeed justify changes in the configuration of meatpacking or other inspection procedures that costs some jobs. There may also be ways to mitigate some of these costs, so the matter does not end here. Nevertheless, there are circumstances where it is appropriate to rebut an ethical critique by pointing out the compelling reasons for accepting certain costs in exchange for progress on other fronts. The Modernist Fallacy consists in presuming that science, technology, capitalism, or maybe just history is inherently progressive, so that any change brought about by these forces is always good. Alternatively, one may believe that any resistance

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to science, technology, etc., is a form of traditionalism or irrationalism that must be overcome. A strong and often justified faith in the power of science to alleviate harms, encourage democracy and promote social justice characterized the period in philosophy and economic history that is now known as Modernism. It had a good run, beginning with the philosophical writings of Francis Bacon and René Descartes, and becoming socially effective during the industrial revolution. During this period, the open and skeptical pattern of scientific inquiry was indeed both a force and a model for the democratization of hierarchical societies, and the technologies of the industrial revolution led to the expansion of European civilization across the expanse of the globe. People will be debating whether Modernism was a good thing for some time to come. Certainly it was less good from the perspective of conquered peoples than it seemed to Europeans who wrote much of the history for the period, but perhaps it is too much to lay the blame for colonial oppression at the feet of science and technology. The point here is that surely no one can take such an attitude of unalloyed optimism toward science and technology today. If the scientific and technological achievements of the last five centuries are on balance good, they can still be made much better by attending to environmental consequences, human health consequences, and social consequences that are the unintended accompaniment of science-based technical change. While only a few intellectuals challenged the philosophical basis for modernism until recently, much of the twentieth century consisted in discovering the health and environmental consequences of the old smokestack industries and of chemical technologies. These discoveries were accompanied by social movements and intellectual developments that undercut the supreme self-confidence of European culture, the culture in which the scientific attitude was historically grounded (Harvey, 1989; Beck, 1992). While science and the scientific attitude are capable of thriving without the social and cultural background of European expansion and colonialism, it is not surprising that scientific and technological achievements of the past have been tarred by some of the less savory aspects of the social and intellectual milieu from which they emerged. The modernist fallacy was particularly relevant to the GMO debate because many critics of biotechnology made rejection of modernist philosophy an important component of their argument. Jeremy Rifkin includes a popularized diatribe against Bacon and Descartes in his books Algeny (1983) and Declaration of a Heretic (1985), as does Andrew Kimbrell in The Human Body Shop (1993). More scholarly versions of the same argument can be found in Mies (1993), Shiva (1993), and McNally and Wheale (1995). The argument is echoed in the more biologically oriented critique of Mae Wan Ho (2000). Finn Bowring (2003) has produced booklength version of it that interprets developments in medical and agricultural biotechnology as part of a grand pattern in the history of science. It is not unreasonable to anticipate that similar claims will be raised in connection with nanotechnology. While I do not claim that the “presumptive case” being made here is an adequate reply to this anti-modern literature, either, to reply to such criticisms with “That’s progress” is to beg the question, to commit the logical fallacy of assuming precisely the point that needs to be proven.

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The late twentieth century may have been a period of overreaction, and biotechnology may have fallen victim to an obsessive fear of science and technology. Yet even if one believes that, an advocate for nanotechnology should not blithely maintain the sort of faith in the progressive nature of science and technology that would permit one to simply dismiss concerns about unwanted consequences without giving them their due. The presumptive case given above is thus about as far as one can go without beginning to take some specifics of critical argument on board. A less critical faith in progress is indeed blind faith, and the sort of faith that has been the enemy of science in the past. How ironic that some scientists become the least scientific in their willingness to dismiss concerns and objections to technology! The Modernist Fallacy is a truly bad argument, and one that should be expunged from even coffee table conversation.

2.5

The Naturalistic Fallacy

Philosopher G.E. Moore described the Naturalistic Fallacy in Principia Ethica (1903). It has since entered the philosophical lexicon as the logical mistake of concluding that something is good merely from the fact that it exists, that it is part of nature, of SOP or the status quo. The fallacy is likely to be committed by certain types of conservatives as well as by those who detest change. It is given a religious backing by those who believe that the world as it is embodies God’s design, but scientists are capable of the Naturalistic Fallacy, too. The instances of the Naturalistic Fallacy that occurred in debates over biotechnology are subtle and a defensible argument could have been made by exerting a little more care and precision of language. They involved making comparisons between natural phenomena and the behavior of transgenic organisms. Such comparisons are not in themselves problematic, but if the point of the comparison is to argue that the behavior of transgenic organisms is unproblematic or in some sense “acceptable,” because the behavior of non-transgenic (or natural) organisms is similar, then the natural phenomena are being invested with normative significance. Such arguments often involve claims about risk, and it is very reasonable to expect that a similar pattern of thinking and speaking may be applied to risks from nanotechnology. Here are two arguments that exemplify the problem. 1. The kind of alterations that molecular biologists are making in plants and animals just like those that occur as a result of natural mutation. They are, therefore, an acceptable risk. 2. Modern biotechnology is just like plant or animal breeding. Since the risks of plant and animal breeding have been acceptable, the risks of biotechnology are acceptable. The first version seems to state that because risks of biotechnology are consistent with risks from natural mutation, they are ethically acceptable. The second version states that because they are consistent with historical risks of plant and animal

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breeding, they are acceptable. Analogs in nanotechnology might state that: because some nanoparticles exist in nature, risks associated with nanoparticles are acceptable; or that the similarity between nanotechnology and prior chemical or material technologies entails that the risks of nanotechnology are acceptable. The first argument is a clear instance of the Naturalistic Fallacy. Moore’s discussion has given this logical mistake its name (though his analysis was both more subtle and more philosophically ambitious than the account given here), but John Stuart Mill called attention to this logical mistake some years before Moore. Mill’s essay Nature noted that we can derive nothing of ethical significance by comparing intentional actions performed by human beings to acts of nature. “In sober truth,” he wrote, “nearly all the things which men are hanged or imprisoned for doing to one another are nature’s everyday performances,” (1873, p. 426). The mere fact that humans must live with the risks of mutation tells us nothing about whether it is ethically acceptable for some to act in such a way as to intentionally bring about such risks. The second instance at least compares like and like. Plant and animal breeding are intentional actions. However, it is not clear that society at large has ever undertaken an informed debate on whether these risks are acceptable, either. Indeed, stories of mistakes in planned introductions—Chinese carp and killer bees—are a commonplace theme in literature that raises concern about the environmental risks of genetic engineering for plants and animals. More informed critics note that plant and animal breeding are often associated with increases in fertilizer or pesticide, creating risk through an indirect mechanism. It is likely that any well-publicized change in food and agricultural technology like biotechnology would have brought on a new debate over risk. German theorist Ulrich Beck has argued that many social issues once debated in terms of class conflict are now debated as issues of risk (Beck, 1992). Given the dramatic changes in technology and social organization that have occurred since World War II, simply assuming that historical trends on risk levels provide evidence for contemporary criteria of risk acceptability is unwarranted. It is possible that what people who offer arguments like (1) and (2) above were trying to say is that the probability of harm from GMOs is quite low. This is not an ethical claim. It is an attempt to infer the probability of harm from biotechnology by analogy to a distinct but relevantly similar sample population for which experience provides good (if not statistically quantified) information about the probability of harmful environmental or food safety consequences. There is nothing fallacious in this general pattern of inference, though inference by analogy can be tricky when examined case by case. Some of the philosophical problems that have arisen in plant scientists’ attempts to use this pattern of inference are discussed in Thompson (2003b). If one is careful in stating the point, however, there can be no objection to using such analogies in estimating risks. But low probability is not in itself enough to prove that a risk is acceptable. When consequences are sufficiently high, when risks are unnecessary, or when people are needlessly prevented from participating in a decision process, even very low probability risks can be socially unacceptable.

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The Argument from Ignorance

Philosopher Kristin Shrader-Frechette is well known for her studies of faulty arguments used in developing the case for nuclear power, for geological disposal of nuclear waste, and for radiation technology in general. She notes that a persistent and disturbing fallacy in that literature that “occurs when one assumes that because one does not know of a way for repository failure or radionuclide migration to occur, none will occur. Such inferences are examples of the appeal to ignorance” (Shrader-Frechette, 1991, p. 105). Technical disparities between radiation issues and risks of nanotechnology notwithstanding, virtually anyone with knowledge of the arguments that boosters of biotechnology brought forward (especially in informal settings) will find the pattern of conduct disturbing enough to warrant a caution for SEIN. Because people cannot imagine how bad things can happen, they infer that bad things cannot happen. Another and more dishonorable version of the fallacy occurs when boosters of technology reported that there is “no evidence of harm (or risk)” associated with early uses when in fact there is no evidence of any kind because no one has bothered to look. Some types of harm would also be very difficult to detect, so the fact that none have been reported needs to be placed in proper context. Failing to do this is apt to be misleading. The fact that the argument from ignorance can be used to mislead links its use to the public’s lack of receptivity toward GMOs. Here is how that link gets made: replete with assurances about the safety of chemical technology and nuclear power, boosters of those technologies forged ahead. Many of their beliefs about the probability of an accident may have been well founded, but the public has become suspicious of such assurances in the wake of accidents at Bhopal at Chernobyl. While biotechnology and nanotechnology may differ from chemical and nuclear technology in many ways, the conduct of the science community is, from an outsider’s perspective, distressingly similar. The appeal to ignorance has failed before; perhaps it will fail again. As in the Naturalistic Fallacy, there are valid inferences that can be drawn from the fact that one cannot imagine how a harmful consequence could materialize. Risk assessment is a process that begins with a systematic attempt to imagine the scenarios and mechanisms that can end in harm. It is inevitable that the scenario no one thinks of will be omitted from the estimate of risk that such exercises produce. Nevertheless, when scientists work diligently to anticipate the full complement of risk, it is reasonable to conclude that unanticipated scenarios are either unlikely or at least not a proper basis on which to reject the technology as a matter of public policy. When researchers have diligently looked for evidence of environmental or health impact it is unreasonable to neglect that work in public decision making. It is not reasonable to think (and no judicious scientist would claim) that the unanticipated scenario does not exist, though this is what the appeal to ignorance effectively does claim. Complacency arises easily when appeals to ignorance go unchallenged, and complacency can result in the exercise of risk analysis being

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pursued less diligently than it should be. If biotechnology is to be pursued in an ethical manner, the appeal to ignorance must be expunged from both daily practice and the public defense of biotechnology.

2.7

The Argument from Hunger

While modernist, naturalist and ignorance fallacies circulate over coffee whenever scientists congregate, a more complex and insidious bad argument for biotechnology became firmly entrenched in public discourse. This is the claim that GMOs are the solution to world hunger, generally accompanied by the claim that those who oppose them are themselves ethically irresponsible in virtue of the misery from disease and starvation that their opposition is alleged to cause. While this argument is, perhaps, tangential to nanotechnology, it is worth reviewing as a case study in how debates over science can go sour. There has always been some hope among agricultural scientists that rDNA techniques would be useful in developing new crop varieties for the developing world. This hope started to emerge as an explicitly developed argument for biotechnology as developed country GMOs began to encounter serious opposition in the 1990s. Advocates of biotechnology began to look for a “poster child”: a biotechnology that was so appealing it could be used to silence the critics. The one that eventually achieved public notoriety was Ingo Potrykus’s “Golden Rice,” the vitamin-A enhanced rice variety intended as a partial response to a widespread nutritional deficiency. Potrykus appeared on the cover of Time Magazine in July 2000 and the accompanying story touted his work as an important advance in the battle against the ills of poverty (Nash, 2000). The story precipitated a continuing series of exchanges between boosters and knockers debating the value of Golden Rice for meeting nutritional needs. The argument from hunger surfaced again in the summer of 2002 when several African countries refused US food aid because it was not certified as “GM free.” The story received substantial play in the US media, where it was generally portrayed as a case of moral insensitivity on the part of African and European leaders, allowing people to starve for fear that future export markets would be lost. While there is little doubt that African rejection of even milled cornmeal (maize) broached the level of paranoia, these stories failed to note that the US routinely takes pains to satisfy purely aesthetic preferences in the delivery of food aid (e.g., delivering white rather than yellow maize), and that since large maize producing regions in the US do not grow GM varieties, it would have been fairly easy for the Food for Peace program to have satisfied a preference for non-GM food aid, as well. If anyone was actually starving while all the dawdling was going on, US officials could be blamed for it as surely as African leaders. In May of 2003, the food aid episode became the centerpiece in a US trade action against the European Union’s continuing reluctance to accept GM crops, (Zerbe, 2004). The argument from hunger has been imbedded in cynical and strategic manipulations from the outset, and it is tempting

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to write it off entirely as a particularly odious form of deceit perpetrated to defame honest critics and dismiss legitimate concerns. Nevertheless, the argument from hunger is complex because for the first time in the history of agricultural science, the developing world is broadly positioned to make substantial use of cutting edge techniques. The much-maligned Green Revolution was largely an attempt to adapt agricultural technologies from the sphere of European influence to growing conditions in Africa, Asia and Latin America. For a variety of reasons, scientists in these areas have a much greater capacity to use biotechnology in response to their own problems than has been the case for agricultural technologies that depend heavily on traditional chemical, mechanical and even breeding expertise, though they continue to work closely with developed country science. As such, it is really true that agricultural biotechnology might well be deployed in response to some genuine problems faced by poor and hungry people in the developing world (see Rosegrant et al., 2001; Nuffield Council, 1999, 2003). It is, however, a rather large leap in logic to move from this carefully stated claim to the claims that biotechnology holds the solution to hunger, or that opposition to biotechnology is morally irresponsible, much less the even stronger claim that opponents of biotechnology are committing acts tantamount to the murder of starving people. Yet all these immoderate claims are heard in defense of agricultural biotechnology. Biotechnology cannot be said to hold the solution to world hunger because as Amartya Sen demonstrated in the path-breaking book Poverty and Famines: An Essay on Entitlement and Deprivation (1981), the misery and suffering of the poor is never due simply to a lack of food. While the techniques now in the hands of developing country scientists might increase yields and will almost certainly help developing country farmers reduce losses from disease and insect pests, solving hunger involves a reform of social institutions that deprive poor people of secure economic and political resources. Lacking these, there will still be hunger, even when there is plenty of food. In fact, some portion of the opposition to biotechnology comes from people who are arguing that social reforms must accompany technical change in developing countries. This claim is at the root of Vandana Shiva’s argument against biotechnology (Shiva, 2000) and is stated repeatedly in grass roots literature coming out of India. To tar biotechnology’s critics broadly as being unconcerned about the poor is either ignorant or cynical in the extreme. The argument from hunger is also insidious because even those who reject it often do so with an equally fallacious and irresponsible reply: the problem is not a lack of food, but a matter of distribution. Like the argument from hunger itself, this comeback has a grain of truth. Sen’s analysis supports the claim that hunger is a problem of distributive justice, but to say this is not to say that the problem would be solved by redistributing food, as if what we need are more boats and trucks. To think that hunger will be solved by exporting surplus production from industrialized countries to the developing world is just as naïve as thinking that a new potato or rice variety is the answer. Many critics of biotechnology underestimate the need to maintain and continuously improve humankind’s capacity for biologically-based responses to problems in agriculture. The productivity of

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industrial agriculture cannot be regarded as a permanent achievement. Not only does it involve levels of water and energy use and forms of pollution that are themselves creating problems, but diseases and pests are constantly evolving and will eventually become resistant to technologies that hold them in check. The case for any new technology in the developing world must be built upon this more subtle and valid foundation, rather than on a simplistic and ultimately misleading portrayal of its ability to “feed the world.” The argument from hunger is a bad argument not because there is no truth in claiming that rDNA techniques will be an important part of the toolkit for agricultural scientists who work to improve food production in the developing world. Once one has witnessed starvation, the imperative for change becomes paramount and impatience starts to look like a virtue. Nevertheless, the main thrust of my research on the GMO debate is that meeting the concerns and criticisms of opponents is among the ethical responsibilities that scientists and decision makers must accept. Telling people to buzz off because we are busy helping the poor simply will not do. While it is certainly possible to take a different view of how far scientists, government officials and industry leaders need to go in meeting the views of critics, it is something else again to promote a simplistic view of poverty and deprivation in order to bring about better public acceptance of biotechnologies that are being used in industrial agriculture today. The argument from hunger is a bad argument because it has been deployed shamelessly and cynically in a manner that promotes continued misunderstanding of the problems of global hunger and of science’s role in addressing them. As proponents of nanotechnology see similar opportunities to alleviate suffering or help the poor, they must resist the temptation to offer arguments that oversimplify and ultimately harm our collective ability to address the problems of suffering and poverty.

2.8

Conclusion

The presumptive case for nanotechnology is strong. In part it issues out of the presumptive case that must be assumed for all technology at this point in history. Technology has always been with humanity, of course, but in the post industrial age it has taken on a systematic character reflected in the organizations—corporations, government agencies and universities—that have been built to develop it and in the agencies—regulatory bodies, legal systems and financial institutions—that create our social filters for picking and choosing which technologies ultimately succeed. The existence of these social filters creates an expectation (at least among those who work with and develop technology) that the applications of nanoscience that run this gauntlet are more likely to be beneficial than harmful. All of which may simply be to say that at present, technological change (including nanotechnology) is a social fact. The most favorable evaluation that follows from the presumptive argument is this: if the broad set of tools and knowledge known as nanotechnology can be

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deployed for good, our ethical responsibility is to support the development and training in the tools of nanoscience in general, and to make assessments of specific products or applications when there are good reasons to suspect that there may be problems, or that costs and unwanted consequences outweigh benefits in a particular case. This orientation to nanotechnology is modest and reasonable, but defending it is philosophically significant not only in light of anti-technology arguments that will inevitably be leveled against all forms of nanotechnology, not simply those that deal with human enhancement, but also because it will help explain the general strategy of SEIN research to scientists and engineers engaged in developing applications of nanotechnology. It will also become practically significant if such philosophical sentiments stimulate public resistance comparable to that which surfaced in the GMO debate. The larger aim of my work has been to evaluate the conditions and particular arguments that have been proposed to limit the presumptive case for biotechnology, discarding some, endorsing others. Something similar will need to happen for nanotechnology. This means that much of the discussion will be focused on criticisms and negatives. Scientists and engineers must learn to accept the fact that although much of what gets said is critical and questioning, the ethics of nanotechnology is not simply a matter of limits and constraints, for the promise technology is real, substantial and should not be ignored.

References Berube, D. 2006. Nano-Hype: The Truth behind the Nanotechnology Buzz. Amherst, NY: Prometheus Books. Beck, U. 1992. Risk Society: Towards a New Modernity, M. Ritter, trans. London: Sage Publications [1986]. Borgmann, A. 1983. Technology and the Character of Contemporary Life. Chicago: University of Chicago Press. Borgmann, A. 1999. Holding on to Reality. Chicago: University of Chicago Press. Bowring, F. 2003. Science, Seeds and Cyborgs: Biotechnology and the Appropriation of Life. London: Verso Press. Burkhardt, J. 2001. Agricultural Biotechnology and the Future Benefits Argument. Journal of Agricultural and Environmental Ethics 14: 135–145. Bauer, M. W. and George G., eds. 2002. Biotechnology: The Making of a Global Controversy. Cambridge: Cambridge University Press. Feenberg, A. 1991. Critical Theory of Technology. New York: Oxford University Press. Feenberg, A. 1999. Questioning Technology. New York: Routledge. Harvey, D. 1989. The Condition of Postmodernity: An Enquiry into the Origins of Cultural Change. Oxford, UK: Blackwell. Ho, M. 2000. Genetic Engineering: Dream or Nightmare? 2nd edition, Revised and Expanded. New York: The Continuum Publishing Co. Kimbrell, A. 1993. The Human Body Shop. New York: HarperCollins. McNally, R and Peter W. 1995. Genetic Engineering, Bioethics and Radicalised Modernity. In Contested Technology: Ethics, Risk and Public Debate, ed. R. Schomberg, 29–50. Tilburg: International Centre for Human and Public Affairs.

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Mies, M. 1993. New Reproductive Technologies: Sexist and Racist Implications. In Ecofeminism, eds. M. Mies and V. Shiva, 174–95. London: Zed Books. Mill, J. S. 1961. Nature. In The Philosophy of J.S. Mill. ed. M. Cohen, New York: Modern Library [1873]. Nash, J. M. 2000. Grains of Hope. Time Magazine 156.5 (July 31): 38–46. Nuffield Council on Bioethics. 1999. Genetically Modified Crops: The Ethical and Social Issues. London: Nufield Council on Bioethics. Nuffield Council on Bioethics. 2003. The Use of Genetically Modified Crops in Developing Countries: A Follow-Up Discussion Paper to the 1999 Report. London: Nuffield Council on Bioethics Rifkin, J. 1983. Algeny. New York: Viking. Rifkin, J. 1985. Declaration of a Heretic. Boston and London: Routledge and Kegan Paul. Rosegrant, M. W., Michael, S. P., Siet, M. and Julie, W. 2001. 2020 Global Food Outlook— Trends, Alternatives and Choices. Washington, DC: IFPRI. Sen, A. K. 1981. Poverty and Famine: An Essay on Entitlement and Deprivation. Oxford: Oxford University Press. Shiva, V. 1995. Epilogue: Beyond Reductionism. In Biopolitics: A Feminist and Ecological Reader on Biotechnology, eds. V. Shiva and I. Moser, 267–284. London: Zed Books. Shiva, V. 2000. Stolen Harvest: The Hijacking of the Global Food Supply. Cambridge, MA: South End Press. Shrader-Frechette, K. 1991. Risk and Rationality. Berkeley: University of California Press. Teitelman, R. 1989. Gene Dreams: Wall Street, Academia and the Rise of Biotechnology. New York: Basic Books. Thompson, P. B. 2003a. The Environmental Ethics Case for Crop Biotechnology: Putting Science Back into Environmental Practice. In Moral and Political Reasoning in Environmental Practice, eds. A. Light and A. de-Shalit, 187–217. Cambridge, MA: The MIT Press. Thompson, P. B. 2003b. Value Judgments and Risk Comparisons: The Case of Genetically Engineered Crops. Plant Physiology 132: 10–16. Thompson, P. B. 2007. Food Biotechnology in Ethical Perspective, 2nd Edition. Dordrecht: Springer. Zerbe, N. 2004. Feeding the Famine? American Food Aid and the GMO Debate in Southern Africa. Food Policy 29: 593–608. Zimdahl, R. 2006. Agriculture’s Ethical Horizon. New York: Academic Press.

Chapter 3

The Bearable Newness of Nanoscience, or: How Not to Get Regulated Out of Business1 Arthur Zucker

Scientists would like to be left alone to do science as they see fit. They would like to be trusted and in general they ought to be trusted. But to think that this will happen, especially as new technologies flow from advances in science, is naïve. The best way for scientists to insure their autonomy—and it cannot be complete autonomy from the public—is to consider in advance, as much as is possible, what issues the public might have with their science and technology and try to forestall obstructive responses to it. This means expanding what counts as “doing science” to include thinking about ethical and social implications of science. Although this chapter is concerned primarily with ethics and nanoscience, it will discuss some philosophy of science. But this is not a digression. Rather it is necessary, since it has been common to see nanoscience as a breeding ground for a new kind of science—one that is holistic even to the point of including ethical values.

3.1

Nanoscience and Fantasy: A Frightened Public

In the movie, The Hand, Michael Caine’s character loses his hand in an automobile accident. The hand is never found but may be responsible for killing those people Caine has reason to hate or fear. The hand has a mind of its own in the sense that Caine himself would not do the killing. In the movie, Frankenstein, the monster is a killer because he (it?) got the brain of a killer; one might say, the brain had the wrong mind of its own. These are fantasies. But not so much of a fantasy is the use of nanotechnology to make prosthetic limbs that would be able to adjust to changes in the body (National Nanotechnology Initiative, 2000). Now just combine this possible use of nanotechnology with fiction and the result is a hand with a life of its own. If this sounds too remote, consider that there is now research on Parkinson’s disease where viruses with special genes are inserted into the brains of sufferers. If one used

1 A version of this paper was presented at: the 3rd International Congress of Nanotechnology 2006 in San Francisco.

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smart nanotechnology particles (particles that were, in effect, computers), we might begin to wonder about issues of personal identity (what makes me the person I am, what keeps me the person I am). To the public, this might be a real scare. A true scare to many Europeans is what is now termed Frankenfood, genetically modified (GM) crops also known as green goo. (Gray goo will be discussed below.) Who would have thought that the negative reaction to these foods would be so visceral? Not the scientists who developed them and not the farmers who grew them, nor the business people who wanted to make a profit from them, nor the grocers, who would have sold them. Some of this fear of GM has been ameliorated. However, if a better job had been done by scientists at the start of the project, at least of some of the fear could have been allayed, thus avoiding the call for a moratorium proposed early in 2003 (Joy, 2000). Bill Joy, founder of Sun Microsystems, has suggested that we might find our end in “grey goo.” He asks us to do a thought experiment where self-replicating nano-machines originally engineered to help us (as in the Parkinson’s case above), wind up destroying us by turning into evil nano-machines, one might say, “nano-Hals” from the movie 2001.2 Michael Crichton’s Prey has a similar theme (Crichton, 2003). Crichton has said that he wants his story taken seriously. Indeed, Crichton says in the introduction to his book, “Sometime in the twenty-first century, our self-deluded recklessness will collide with our growing technological power. One area where this will occur is in the meeting point of nanotechnology, biotechnology, and computer technology. What all three have in common is the ability to release self-replicating entities into the environment (or into us)” (Crichton, 2003, p. xiii). Of course, this view of Crichton’s should not go unchallenged. That is why facing the ethical issue surrounding nanotechnology is so important. To see this, compare the following excerpts from reviews of Prey. Washington Post writer Jonathan Yardley (2002) says that “Crichton has figured out how to package complex scientific, technological and biological matters in ways that go down easily for the mass audience, and this is by no stretch of the imagination a bad thing. He tells exciting (if often somewhat improbable) stories, and he is genuinely concerned about important issues, in this case ‘the obstinate egotism that is a hallmark of human interaction with the environment.’” This review by Yardley focuses only on the literary merits of the book. Otherwise, the message about nanotechnology gone wild is merely reported. The review offers no careful

2

Joy went on: “The 21st-century technologies—genetics, nanotechnology, and robotics (GNR)— are so powerful that they can spawn whole new classes of accidents and abuses. Most dangerously, for the first time, these accidents and abuses are widely within the reach of individuals or small groups. They will not require large facilities or rare raw materials. Knowledge alone will enable the use of them. Thus we have the possibility not just of weapons of mass destruction but of knowledge-enabled mass destruction (KMD), this destructiveness hugely amplified by the power of self-replication. I think it is no exaggeration to say we are on the cusp of the further perfection of extreme evil, an evil whose possibility spreads well beyond that which weapons of mass destruction bequeathed to the nation-states, on to a surprising and terrible empowerment of extreme individuals.” Editorial (2003).

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and extended evaluation of the message of Crichton’s book. Nowhere does Yardley dissect the possible frightening scenario for scientific errors. On the other hand, Freeman Dyson (2003), a physicist, points out that: …Jack (a character in the novel) encounters swarms of nanorobots chasing him in the open air like a swarm of ants or bees. These nanorobots are flying through the air as fast as he can run. Fortunately for Jack and unfortunately for the story, the laws of physics do not allow very small creatures to fly fast. The viscous drag of air or water becomes stronger as the creature becomes smaller. Flying through air, for a nanorobot the size of a red blood cell, would be like swimming through molasses for a human being. Roughly speaking, the top speed of a swimmer or flyer is proportional to its length. A generous upper limit to the speed of a nanorobot flying through air or swimming through water would be a tenth of an inch per second, barely fast enough to chase a snail. For nanorobots to behave like a swarm of insects, they would have to be as large as insects.

But how many reviewers have the sophistication of Dyson? What this means is that Crichton has the advantage on nanoscience—at least until nanoscientists themselves get across to the public just what nanoscience is and is not, can be and almost assuredly cannot be, without forgetting a clear discussion of what nanoscience should not be.3

3.2

Nanoscience, Philosophy of Science, and Ethics: What’s New?

George Khushf in his important article, “Systems Theory and the Ethics of Human Enhancement: A Framework for NBIC Convergence,” has emphasized the need to turn from a naive reductionism to a systems theory approach demanded, he thinks, by nanoscience (Khushf, 2004).4 Briefly, he argues that the sharp pre-nanoscience 3 Dr. Charles Roselli of the Oregon Health and Science University has been studying sexual orientation in rams. Since some rams prefer sex with other rams, Roselli’s research into the basic physiological mechanism of sex choice would have important implications for breeding of sheep. Gay activists have been outraged by his research, seeing it as a way to cure being gay. This is not what his research aims at rather this interpretation is the result of distortion by press reports. Roselli has said “…human sexuality was a complex phenomenon that could not be reduced to interactions of brain structure and hormones.” He has also said that he is repulsed by the idea of “sexual eugenics” Where did he say this? Page#? Nonetheless, a PETA representative said that altering sexual orientation was a “natural implication” of Roselli’s work. The representative quoted Roselli as saying, “[the research] has broader implications for understanding the development and control of sexual motivation and mate selection across mammalian species, including humans” Where was this quote? It has been pointed out that Roselli meant ‘control’ only in the sense of “understanding the body’s internal controls.” Even so, University of Pennsylvania ethicist, Paul Root Wolpe, said, “I’m not sure I would let him off the hook quite as easily as he wants to be let off the hook…[he] opened the door” and “he has to take responsibility for the public response.” Is it so difficult to see something analogous happening to a nanoscientist? (Schwartz, 2007). 4 For a series of articles on nanotechnology and ethics, guest edited by Robert Best, George Khushf and Robin Williams, see The Journal of Law Medicine and Ethics, 34:4, Winter 2006. See also Allhoff et al. (2007).

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dichotomy/discontinuity between reductionism and holism must be abandoned and with it, the equally sharp distinction made between science (facts) on the one hand and ethics (values, from which flow regulations) on the other hand. Until now, he suggests, scientists have always seen regulations as values imposed from the outside; imposed by non-scientists, who see the world holistically and not reductionistically, the way scientists do. Thus, regulations have always been easy to see as hampering the progress of science. Once reductionism and holism are blended into one world view, “ethical issues in nano-science [will] reflect the character of the new science itself. No longer…[will]… such issues be dealt with in an isolated way by ‘ethicists’ or by scientists alone. The issues are…too complex, and they [will] require the full range of skills of those in the sciences and the humanities.” (Khushf, 2004) Making regulations friendlier to practicing scientists is an admirable goal. But Khushf’s way of doing it raises some questions. They turn on two discontinuities each of which I shall pursue in some detail. They are discontinuities between reductionistic science and holistic science on the one hand and facts and values on the other.

3.3

Senses of Reductionism

One can easily distinguish at least eight different senses of “reductionism”: Compositional. This is the claim that big things are made of smaller things and that, while the properties of the small things may be used to account for the properties of the bigger things, this is to be discovered and not assumed. Mathematical. Whatever can be modeled mathematically can be said to have been reduced to this model. The Punnett Square, a simple matrix, used to show simple genetic crosses, is a very simple example of a mathematical model. Objects of study. In genetics, the shift from using relatively macro-organisms like corn and fruit flies to microorganisms such as bacteria and viruses is a trend that began in the early 1930s. It is an example of this sort of reductionism. Although the methods of study will probably change with the objects of study, they may not. Thus this version of reductionism is distinguishable from one that focuses on method. See methodological below. Mechanical. The claim that all explanations should be put in mechanical terms is a reductionistic claim. A mechanical explanation is likely to be picturable through a mathematical model. A spring mechanism watch can be explained on the basis of its parts and one can give a mathematical picture of how the watch works. Yet, the properties of the spring will not by themselves explain the workings of the watch. It is the touching and the motion caused by the touching that does the explaining. If we assume that Mendel’s second law is explained cytologically, it is the properties of the molecules that in turn cause (explain) the motion of the chromosomes. Here we have a mix of compositional and mechanical reduction.

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Monistic. The claim that there is only one basic (kind of) explanatory principle. Notice that vitalism, for example, is reductionistic in this sense.5 This sense is neutral to the preceding ones. Translatability. The strongest version of this sense would claim that if one theory is reducible to another, then the laws and definitions of the reduced science must be translatable without remainder into laws and definitions of the reducing science. Thus in any proposed reduction of biology to chemistry, the laws of biology (if there are any) would have to be translatable with no remainder into the laws of chemistry. Whether those laws are mechanical, mathematical, monistic, compositional is completely irrelevant. A weaker version would not hold out for translatability with no remainder. Instead, it would allow some remainder with the understanding that how much and what sort of remainder is allowed would be open to argument. Deducibility. If one theory is reducible to another, then the reduced theory must be derivable from the reducing theory; or at least derivable from a close version of the reducing theory. Strictly speaking, just because one theory is deducible from another, does not mean that the former can be translated into the latter. Nor does translatability imply deducibility. This sense of reduction is also neutral to the previous senses. Methodological. An object of study, e.g., a person, almost always has levels of organization. A person exhibits macro behavior, has organs, tissues, cells, genes, etc. Notice that the levels are often designated higher and lower in terms of their size and composition. Often, each level has a distinctive method of study. When a method of study used for a lower level replaces one used on a higher level, one can say that there has been a methodological reduction. Such a replacement occurs usually when the lower level method is easier than the higher level or when the lower level method gives better results (and/or offers better explanations) than the higher level method. For example, studying some diseases genetically can give a better picture of who has the disease than the traditional upper level diagnosis based on a history and a physical in a doctor’s office. Some philosophers claim that there really never is reduction in any of these senses. Rather there are replacements. This may be a verbal question. Again, the reasons for ease of study are numerous and while they may be related to compositional or mathematical, this sense is still, logically, neutral to the preceding senses. While each of these forms of reductionism are logically distinct with no one form entailing any other, historically, as compositional reduction takes place, methodological reductionism tags along with it. Reduction can be a relationship between: single statements within a theory; theories within disciplines; entire disciplines that are related; single statements

5

Vitalism is the view that living things are different in kind from non-living things and that the difference is made by a unique to living things principle, sometimes called élan vital; a view often associated with holism.

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between different theories; theories in different disciplines; moderately different disciplines; and very different disciplines. The distinctions between intra-theoretic and inter-theoretic reduction has been studies exhaustively by William Wimsatt (1980). One might think that this is just a philosopher’s dream world. But real scientists worry about these abstract issues.6 If at least some of the above senses for “reduction” are reasonable, then denying them one, severally or all at once, will yield different senses for holism. The best way to see the importance of the issue of reductionism is by opposing it to holism. Holists have a view of the world that when applied to science, has ramifications. To be a holist is to be committed to doing science in a certain way, to using certain kinds of explanation. If one sees these ways, sees these explanations, as inimical to science and to the progress of science, then defending some form of reductionism will take center stage. Otherwise, the issue “Is X reducible to Y” seems no more than an exercise in rhetoric. Holism is often characterized as the view that for systems of even minimum complexity, the whole is greater than the sum of the parts—meaning that explanation and prediction require dealing with more than just one part of the system. In traditional philosophical systems, holism would be a monism as in Benedict Spinoza and G.W.F. Hegel. The typical problem with a strict monism is that nothing can be known until and unless everything is known. Interestingly, since monism can be a form of reductionism, we can get a reductionistic holism! However one characterizes holism, the only way for its implied methodology not to fly in the face of what has proven to be a very successful scientific method, is for holism to embrace a method based on breaking things up into systems and then into subsystems until one gets the sort of explanation one is seeking. But the object of this embrace has never seemed attractive to holism; indeed, it has always seemed anathema. It may be that the crux of the difference between holism and reductionism is the sort of explanation one seeks. In general, reductionistic explanations are mathematical and based on mechanisms. Holistic explanations tend to be more qualitative and descriptive (discursive). Again, this difference may also reflect the subject matter. Some subject matters lend themselves to reduction

6

See the Conference to Discuss Reductionism and Emergence, http://www.usfca.edu/ usfnews/03/10.07.03/briefs.html, Cited 1 June 2007. Top theologians, philosophers, and scientists will gather at the University of San Francisco to discuss the twenty-first century’s essential existential question: can you define a being by its component parts (molecules and cells) or is it something more? The interdisciplinary conference, Reductionism and Emergence: Implications for the Science/Theology Dialogue to be held at the University of San Francisco Oct. 7–11, will involve 28 specialists in the sciences, philosophy, and theology from all over the US and the United Kingdom. Topics to be addressed include: How can we properly understand the emergence of new properties and behaviors in life forms as complexity increases? Can complex behaviors be “reduced”—adequately understood and modeled—simply in terms of the properties and behaviors of the components of the systems? What can scientific and philosophical research on these issues contribute to theological understanding of God’s creative action in our universe? What can critical philosophical and theological reflection and research contribute to our overall understanding of the mysteries of life, consciousness, and personhood?

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and others are more receptive to holistic approaches. But whether a subject matter is best attacked discursively or not should be a matter of inquiry, it should be discovered, not decided beforehand based solely on philosophical predilections. In sum, trying to combine reductionism and holism into one philosophy of science that would guide the development of any science and not create a stultifying scientific method would be a monumental task. Thus, it is possible (probably likely) that the ideal of combining reductionism and holism is a will-o-the-wisp. Moreover, if the new science is discontinuous from the old science and if the new science is a hybrid consisting in part of what used to be called ethics, will the new ethics even be recognizable as ethics? Will “good” have become, by definition, successful science? Will successful science be the criterion for goodness? Will successful science be measured by traditional, i.e. pre-discontinuity, criteria or will “successful” have taken on a new meaning? This new hybrid of science and ethics is no more easy a task to conceptualize than the mix of reductionistic and holistic science. At least two issues are intertwined here. One is akin to the problems raised by the ideas of Thomas Kuhn on incommensurability. The other issue relates to the nature of ethics—just how naturalistic (close to being a factual discipline) can ethics be and still maintain its normative force?

3.4 Kuhn’s Later Views on Incommensurability Incommensurability relates to inability to translate perfectly from one paradigm into another not to an inability to interpret. The translation problem for science comes from its theoretical language. Important theoretical terms are defined in terms of each other (implicitly defined). The result is that breaking them apart becomes almost impossible. Thus Kuhn limits incommensurability to this theoretical side of science. But even this limited version of incommensurability leads to problems with comparing different theories. Kuhn used the expression “taxonomy” to mean the way a theory classified its objects of study. As theories change so will their classificatory schema. For example, once some children were considered less smart than others, now we know that there are learning disabilities. With new categories come new ways of speaking and thinking about the objects of study; this is how meanings change. With changes in meaning, confusion can easily result. There are two important questions that must be asked when comparing theories with different taxonomies. One question is: how much overlap is there in the taxonomies? The other question is: how much tweaking of the old taxonomy must be done to include new findings based on the new taxonomy? In other words, Kuhn’s view is that one cannot merely add a new category, one must change at least a part of the entire classificatory scheme (Kuhn, 2000). There is an interesting clash then between what Kuhn articulates as incommensurability and Khushf’s picture of science where ethics is integral in a new way. Basically, a Kuhnian approach suggests that the new theories would be so new and different that we likely would not know what to make of them.

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Ethics: Facts and Values

As a reminder, views of Khushf (2004) here are: “ethical issues in nano-science [will] reflect the character of the new science itself. No longer…[will]… such issues be dealt with in an isolated way by ‘ethicists’ or by scientists alone. The issues are…too complex, and they [will] require the full range of skills of those in the sciences and the humanities.” Saying that “ethical issues in nanoscience will reflect the character of the science itself” calls for clarification. Of course, “reflect” is a metaphor and has to be spelled-out. “Reflect” here might mean that ethical issues will be factual as are most of the parts of traditional nanoscience; or it might mean that ethical issues are to be analyzed using the scientific method that nanoscience uses. It might also mean that the methods of ethics should be applied to nanoscience. It is not clear that Khushf is committed to the claim that values are nothing more than facts. But it is clear that Khushf sees a very close relationship between ethical issues and the new science of the nanoworld. He must certainly be denying any strict dichotomy between facts and values. This dichotomy has a long history and plays an important part in contemporary ethical theory. Thus a brief look at the question “Are values and facts distinct?” is worth a bit of a rehash. At the start, it is worth noting that one reason for wanting to keep values and facts separate is that facts do not seem to have any motivational force without a desire to act on them. A usual claim is that each desire represents a value. It is the value that motivates. The Scottish philosopher David Hume (1711–1776) argued that from facts alone, only facts could follow. Put somewhat differently: To derive an “ought” one must start with more than a mere “is” (Hume, 2000). Hume gave what has come to be a famous example. If the world were threatened with annihilation and I could save it by wriggling my pinky, it would not follow that I ought to wriggle my pinky. For this to follow I would have to want to save the world. An example from art may make Hume’s point even clearer. Imagine all the facts about the Mona Lisa: its size, the subject, the placement of various colors, etc. Nowhere on this list will be the property “beautiful”. It seems clear that, from a list of the facts (which is just a list of the physical characteristics of the painting), it would not follow that the painting was beautiful. Nor would I be moved to spend a few extra minutes looking at the Mona Lisa (or even seeking it out at the Louvre) merely because I had read the list of facts that constitute the Mona Lisa. The British philosopher, G.E. Moore (1873–1958) named the fallacy of trying to derive a value from facts alone, “the naturalistic fallacy.” For Moore, deriving “I should go to the store” from “I have no bread” and “The store has bread” was just as much a fallacy as claiming that “All dogs are cats” follows from “All dogs are mammals” and “All cats are mammals.” A fairly everyday case will help pin down the fact/value dichotomy. Suppose you are at a restaurant with a friend. You have eaten there before, but your friend has not. She asks you, “What’s good?” Notice that she might also have said, “What do you recommend?” or “What should I order?” If, in answer to “Should I order the chicken paprikas” you say, “Chicken

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paprikas is a dish of Hungarian origin made with a red somewhat spicy powder and finished with sour cream” you would not have been any help to your friend; unless you already knew that your friend was/was not partial to chicken, red, spicy powder and sour cream. This makes the point that evaluations—statement of values—are more than mere descriptions of the world. But there is another side to the fact/value question; one that denies the fact/ value distinction. Moral realism is the view that moral claims are made true (or false) by moral facts; these moral facts are independent of our beliefs and these moral facts make moral claims true or false. This is the case for science where we believe that scientific claims are true or false independent of our beliefs.7 Armed with the above account of facts and values, Khushf seems to fall on the moral realist side of the debate. This is not the appropriate venue to debate the wisdom of this. But it is important for this paper to point out that Khushf has to answer which of the following most closely matches his claim: values will be reduced to facts— with ethical decisions also reduced to looking only at facts; given the above discussion of Kuhn, are values translated into facts or merely interpreted as facts, given the new taxonomy that will undoubtedly be needed; or will the new meaning of “value” be incommensurable with the old, pre-nanoscience meaning of “value”? The new taxonomy that would come with values as facts, would almost certainly make the new ethics look very different from the older, pre-nanoscience ethics—a claim suggested earlier. Now, given our look at Kuhn and Hume and Moore, we can see precisely why.

3.6

Implications for Nanoscience and Technology

Vartan Gregorian quotes Leon Kass, as criticizing the view that technology is “the sum total of human tools and methods, devised by human beings to control our environment for our own benefit.” This view of technology sees it only as an instrument, as neutral. Whatever problems arise from technology are due to inappropriate use. Regulations can cure such improper use. But to Kass, technology (and science) are bound together with values in that technology can change the very way we see ourselves and think about ourselves; the way we approach old questions such as, “What is the meaning of life?”, Gregorian (2005) points out that “humanity has always craved meaning and wholeness, and when people do not have the ability or the knowledge to separate fact from fiction, to question deeply, to integrate knowledge, or to see coherence and meaning in life, they feel a deeply unsettling emptiness at the core of their lives.” Technology growing out of pure science can help, but only if it does present a coherent picture of the world, where “coherent” would have to capture facts and values. Gregorian goes on to point out that science and

7 It is possible to hold that moral claims are meant to about moral facts, but that there are no such facts and therefore that all moral claims are false. This latter view is called error theory.

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technology could have a “transforming influence on our thoughts and purposes.” Put in Khushf’s terms, the new science, nanoscience, would have in it, would “reflect,” to use his word, answers to such metaphysical, religious and personal questions as “What is the coherence and meaning in life?”8 (In his article, “Nanotechnology, Risk, and Uncertainty,” James Wilsdon pursues the discontinuity problem in a different way. He says that regulations for nanotechnology will depend on whether nanotechnology is totally different from previous technologies. If there is a discontinuity, then totally new type regulations will be sought. If not discontinuous, then “only incremental tweaks” of current regulations will be needed. Nanoscientists, he points out, try to play both sides. First they glamorize nanoscience by stressing its uniqueness and then, when it comes to regulations, they claim that it is just regular science—only smaller (Wilsdon, 2004). This can seem disingenuous.) Will we be led by this new picture of science to expect new ethical issues? If we wait for new ethical issues (assuming we could recognize them!) and should no new ethical questions appear, we will feel safe. But this may be misleading for two reasons. First, the hybrid view of science proposed probably cannot be sustained and so, on these grounds, there will not be any new ethical issues. Second, the ethical issues that are raised, and will continue to be raised, by nanotechnology are not new at all. This is easy to show.

3.7

No New Issues

The ethical issues mentioned in connection with nanotechnology are: issues in environmental ethics (affects of GM); contagion by grey goo; use of nanotechnology for weapons and for invasion of privacy. Some uses of nanotechnology in medical devices lead to questions of allocation (who will be able to afford the devices), who will be subjects in experiments testing the devices, and personal identity (e.g., am I still the same person when a nanorobot is working with my brain?) These are all examples of ethical issues that have been discussed previously, many since the time of the ancient Greeks. It is just that they are now more relevant and much more pressing. They also appear in the media in ways that more staid issues in ethics are rarely seen (Grunwald, 2005). Two examples from the Annals of the New York Academy of Sciences, “The Coevolution of Human Potential and Converging Technologies,”9 will show how new science and technology may highlight ethical problems without actually 8 All this may be correct and quite insightful. But it is worth noting that Gregorian and Kass do not see nanoscience in a privileged position to change our conceptual picture of the world. Kass is most interested in what is often called the “new genetics.” Gregorian is looking at science and technology in general. 9 Annals of the New York Academy of Sciences, “The Coevolution of Human Potential and Converging Technologies,” May (2004), Vol 1013.

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bringing new ethical issues into existence. The views of Leon Kass, previously Chair of the President’s Council of Bioethics, will once again be mentioned. They too will show that there are no new ethical issues. First, consider Sonia Miller (2004), who, in her article, “How the Legal System Should Change as a Result of Converging Technologies,” says, “The collaborative and futuristic nature of converging technologies requires the legal system to revisit: 1. 2. 3. 4.

the traditional role law has played in society; its educational approach; its method of instruction; and its present techniques of communication in training its lawyers…”

Second, consider Mihail Roco “Science and Technology Integration for Increased Human Potential and Societal Outcomes” in which he (Roco, 2004) says, “Integration of NBIC tools is expected to lead to fundamentally new products and services, such as entirely new categories of materials, devices, and systems for use in manufacturing, construction, transportation, medicine, emerging technologies and scientific research. Fundamental research will be at the confluence of physics, chemistry, biology, mathematics, and engineering…One needs to develop anticipatory, proactive measures in order to limit the risks, on one side, and to accelerate the benefits of converging technologies on the other…six areas of improving human and social performance were discussed first in…and expanded in this volume: Expanding human cognition and communication; Improving human health and physical capabilities; Enhancing group and societal outcomes; Strengthening national security; Unifying science and education [and] Reshaping business and organizations.” Each author tries to show how advances in nanoscience and nanotechnology can force a reexamination of, in one case, what counts as the practice and teaching of law and in the other, how to balance risk and benefit. Yet the issues specifically raised, viz., changes in the legal practice and its pedagogy are old issues. For example, the need to bring scientific data into legal briefs began in the early twentieth century with Louis Brandeis arguing in Muller v. Oregon, 208 U.S. 114 (1908), that women should be allowed to work shorter factory hours than men—supporting this claim with sociological data. Such scientifically supported briefs came to be known as Brandeis briefs. The proactive balancing of risks versus benefits mentioned by Roco requires imagination, knowledge and extrapolation—not a new technique. Nor does the balancing act required between improving health and limited resources bring up a new problem. Daniel Callahan, for one, has been writing on this topic for years. See his False Hopes: Why America’s Quest For Perfect Health is a Recipe For Failure, Simon & Schuster; (April 10, 1998). Kass has said the following about extending human life to the point where neither morbidity nor mortality would be an issue, a situation that might come about as a result of successful bionanotechnology. Let me suggest, then, that a flourishing human life is not a life lived with an ageless body or untroubled soul, but rather a life lived in rhythm Ned time, mindful of time’s limits, appreciative of each season and filled first of all with those intimate human relations that are ours only because we are born, age, replace ourselves, decline, and die – and know it. It is

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This passage is not so much an argument as it is a statement of a philosophy of life. That this is a philosophy of life is easily recognized by anyone who has ever read any philosophy or theology; or, for that matter, thought about these sorts of issues. That is, Kass is talking about very old questions. Of course, the tenor of his remarks is important for the development of any medically related technology. If we let ethics become science and we merge science and business in nanotechnology startup companies, it is all too easy to see the ethics of nanotechnology becoming the ethics of business especially as the public now sees the ethics of business, viz. the ethics of Enron fame. Put less radically, many business people still appeal to the business ethics of Milton Friedman: The obligations of corporations are to the owners of the corporations. Social and moral obligations are limited to obeying the terms of contracts and not violating basic moral expectations. Put somewhat succinctly (and perhaps uncharitably): If it is not grossly immoral and it is not clearly illegal and it makes a profit, do it. This business philosophy never seems acceptable after great harm has been done to the public.10 But again, business ethics is at least as old as the Roman comment “Caveat emptor.”

3.8

Three Morality Tales

These tales are recent episodes from the recent history of genetics. The first has to do with the very recent history of gene therapy. The second is a recounting of the 1975 meeting at Asilomar where recombinant DNA guidelines were hashed out. The third is a discussion of the stem cell controversy; a controversy that can be used as a model for the nanoscience/nanotechnology and ethics question because the questions raised by stem cell research, from its pure science aspect through its technology and including its business possibilities, touch on questions of ultimate human value as well as ethical decision-making.

10 For a statement by Milton Friedman of his views, see his 1970 New York Times Magazine essay, “The Social Responsibility of Business Is to Increase Its Profits.” This article is reprinted in just about every business ethics anthology.

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Gene therapy appeared to be a promising road to cure for some genetic diseases. But gene therapy ran into very early problems. Jesse Gelsinger died while under experimental gene therapy treatment at the University of Pennsylvania. His father sued the University. Dolores Aderman also sued the University of Pennsylvania after having been a subject in one of their gene therapy experiments. She claims that the University failed to disclose to her all the risks of the experimental treatment. Moreover, she was never made aware of the fact that researchers had a financial stake in the experiment. Dr. James Wilson, who directed the gene therapy program, was also a founder of Genovo, a biotechnology company. Both he and the University owned part of that company. Not telling her this amounted to a violation of her “essential dignity,” Ms. Aderman claims. As a result of therapy, she suffered liver damage and psychological problems. Also, she claims that the University was more interested in “fame and glory” than in her well-being. In 2000, Philip Noguchi, M.D., director of the Cellular and Genetic Therapy Division in FDA’s Center for Biologic Evaluation and Research (CBER) said, “Participation in gene therapy trials is way down because the public is not sure what to make of this, said. They want to know what the government is doing to help restore the confidence in this field” (Thompson, 2000). The response of the federal government was that the FDA closed all the University of Pennsylvania gene therapy trials. The University limited the research of Dr. Wilson and barred him from human experimentation. Other research units also suspended their work. Gene transfer safety symposia were held. The idea was to get researchers discussing safety. One would have thought that the discussions had already taken place. Reciting these cases is not meant to suggest that nanotechnology will die out under pressure of government imposed regulations or that gene therapy is not worth pursuing. In fact, if we jump ahead to 2005, we read the following from Arthur Caplan, the Chair of the Department of Bioethics at the University of Pennsylvania. “The Gelsinger case marked a series of setbacks to gene therapy. But it is now gaining momentum due to new safety precautions and good results. The Gelsinger death absolutely set back gene therapy work internationally. It was basically a lot of optimism, and then in the first human trial, someone died. The notion after this incident was that gene therapy was filled with buccaneers, people on the edge.” (Strohmenger, 2005) Caplan saw the quick negative reaction of the public as due to “excessive hype of the field prior to the incident.” At least in Caplan’s eyes, the hype was used to catch the eyes of investors. Inflating figures to mislead investors is illegal hype. But to the public the distinction between illegal hype and misguided but well meant, zeal may well be lost. There are two points to be made. The first is that hyperbole can easily backfire, and the second is that, while not all adverse outcomes can be predicted or defended against, it is possible and a very good idea to have regulations in place, since this shows thought, and care, in a word, good faith. It is important to provide full information to, and for the public, and to watch for conflicts of interest in researcher/ entrepreneurs. If this sounds naïve, consider the Asilomar meeting. In 1975, as a result of a conference called in Asilomar, California, public fears concerning recombinant DNA technology were allayed. Perhaps more important,

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momentum to anti-recombinant DNA forces was denied. Scientists at the meeting agreed that recombinant DNA research needed strict guidelines, which were put into place by the NIH. In his recollections, Paul Berg (2004) says, “[public] fear was fanned by the popularity of visions of The Andromeda Strain and the myriad of ‘what ifs’ floated by both serious and demagogic commentators.” All of this, of course, sounds familiar with Prey playing the role of The Andromeda Strain. Berg points out that the action of the scientists in proposing the regulations and furthering public discussion avoided severe restrictions from the government. Asilomar was successful because its impetus came from scientists themselves. It was not forced on them because of some untoward consequences. According to Berg, another reason for the success was that the media covered the meeting in great detail; they were able to ask questions and get immediate answers. But Berg feels that the Asilomar model, as he calls it, is not relevant to issues such as gene therapy and GM crops. He lists the following reasons. Talk about risk today comes from the media, novelists, and public interest groups, not from scientists themselves. Scientists no longer have the high ground. As Berg (2004) says, “The [recombinant DNA research] issue and its resolution were complete before an entrenched, intransigent and chronic opposition developed. Attempts to prohibit the research or reverse the actions recommended by the conference threatened but never generated sufficient traction to succeed.” Moreover, today’s issues are in part the result, in the eyes of the public, of self-interest—scientists seeking fame and glory; or just plain profit. The controversy over the use of stem cells arose because stem cells were harvested from unused embryos, which were then discarded. In reproductive technologies, many extra embryos are made, frozen and then discarded. Why discard them when they can be put to use? But perhaps we should be asking, “Why make them in the first place?” Or, perhaps, we should be asking, Aren’t these embryos potential persons with presumptive rights to life such that we should not do research on them at all—since we cannot get informed consent? Stem cell research is not nanotechnology but the controversy is a model for ethical issues raised over new scientific techniques, the technology it makes possible and the good or bad that is foreseen. As this example will show, critics of stem cell research argue from very basic values and a picture of what it is to be human to the claim that stem cell research should be eliminated or, at the very least, regulated very carefully. This overlaps Gregorian’s claim mentioned above that science and technology could have a “transforming influence on our thoughts and purposes.” That is, it would be a mistake to think that nanoscience is, and will be seen as, or for that matter, should be seen as, free from this kind of critical analysis. Critics of stem cell research argue from basic values because ethical theories give no clear answers to “Should we pursue stem cell research and if so, how?” The Utilitarian principle, “always do that action which leads to the greatest good for the greatest number” is not the only ethical philosophy to support stem cell research. Just about any of the feminist ethical theories (based on care or trust or sympathy or community) would also support stem cell research. As Carol Gilligan might point out, who among us would prefer a rule against research on blastocysts if it meant standing in the way of helping the sick? Virtue theory, from Aristotle to

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MacIntyre, might also support stem cell research. We might see the willingness to sacrifice a blastocyst in order to help people with Parkinson’s disease as a virtue. Or, we might see it as an example of courage in the face of a political bureaucracy. A Kantian style deontology is also open to interpretation but it could support stem cell research on the grounds that it is an act of helping others; something that Kant says is an imperfect duty, i.e. one that can be overridden, unlike, “Do not lie,” which is a law unto itself.11 What leads to a clear answer is a choice in bottom-line values. Answering, “Is an embryo so worthy of respect that its potential life should lead to policy that trumps any possible research?” will betray some of those bottom line values. The usual people who argue against stem cell research think they are protecting a traditional sense of humanity from a particular kind of assault. They see themselves as protecting us from the discovery that we are just our genes or that we are just our nanoparts. In a New York Times article, Peter Steinfels tried to put his finger on just this point about being human as the crux of the issue (Steinfels, 2001). After pointing out that The Human Embryo Research Panel that advised the National Institutes of Health in 1994 recommended that stem cell research be limited only to 14 days after fertilization mainly because that is when the possibility of twinning ends and the primitive streak appears, he went on to ask, “Are ethical limits, to which everyone gives lip service, really based on some inherent and morally significant quality of human life? Or are they strictly provisional and external dividing lines, like the movable rubber cones or wooden horses that are used to block off road work or parade routes, handy enough to allay anxiety and ward off conflict for now but easily shifted if the potential benefits of medical research so require?” Steinfels suggests that external criteria such as “needed to research Parkinson’s disease” should not be decisive. His worry is that in the end, “adding to the store of knowledge” will be the one fixed point of reference. And that this might justify too much. What might these internal and inherent properties of human embryos be? Just plain being a member of Homo sapiens? The potential to be rational? The potential to be moral? Whatever the properties, they will almost certainly be open to contention because they are so theoretical. And so we have to ask, should they be the basis for policy? Should they even be internal to science; should science “reflect” these views? Isn’t is best if the ethical criteria be left outside science, left to guide science, rather than be science?

3.9

Conclusion

What lessons are there here for nanoscience? Steinfels, as noted above, despite his argument, actually provides a reason for keeping ethical principles separate from science. This is quite different from

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See virtually any anthology covering ethics, e.g., Arthur (2005).

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Khushf who claims that ethics will be a part of nanoscience. But now we can see a danger with Khushf’s way of viewing ethical values, a danger different from the one suggested by Kuhn. There is no way to keep “adding to the store of knowledge” from becoming a guiding ethical principle. If it is a questionable principle, then it is better to keep it external to the science. Otherwise, as noted above, the success of the science will underwrite the use of the science. Put in what is now almost trite terms, “because we can, will have justifiably become, we should.” Nanoscience may discover things we didn’t know about ourselves but it is easier and less unsettling to the public to keep a prima facie dichotomy between what we discover and what we value. Of course, discoveries can change what we value. What may lead to unnecessary regulations is less this sort of gradual change and more the fear that some basic values are under immediate assault by discoveries of science. To avoid this perception—where it is merely a perception—nanoscience will have to be vigilant. As previously noted, the media has to be kept informed of what is being done, what is likely to be done and what the real implications are for society. The real implications have to be clearly marked off from the science fiction versions. To avoid what Berg feels is the loss of the high ground, conflicts of interest (as noted in the University of Pennsylvania case) must never be hidden (this issue keeps appearing in science and medical journals). Universities have conflict of interest policies. There is a similar need for any nanotechnology start-up company to have a code of ethics (not just a mission statement) which includes a conflict of interest policy. As for fame and glory, they are presently important motivators. It would be unrealistic (and perhaps unfair) to suggest that fame and glory not be sought in one’s scientific career, given the way science as a profession is structured. However, what this should be taken to signal is the need for a reexamination of science as a profession. The ethical problems raised by nanotechnology, as shown above, are not new; they are old philosophical questions. Rachel Carson published Silent Spring in 1962. The line between man and automata (a word coined by Descartes [1596–1650]) between man and robots (a word coined by Czech playwright Karel Capek [or his brother Josef] in 1920) are again old stories. The issues raised by clinical trials for gene therapy are standard issues in consent. Doomsday predictions are part and parcel of many technological advances from the steam engine to germ theory; from eugenics to nuclear energy. In general, the comments from Gregorian and Kass concerning the link between science, technology and questions of meaning show this; for what is an older set of questions than “What gives life meaning?” “What is that meaning?” and “How can that meaning be found?” Speaking from the vantage point of philosophy, there are—if nothing else— approaches to answers, on file so to speak, in the history of philosophy. Scientists ought to pursue answers from philosophy, think about them and make them part of how science is taught.

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References Allhoff, F., Lin, P., Moor, J., and Weckert, J. eds. 2007. Nanoethics: The Social and Ethical Implications of Nanotechnology. Hoboken, NJ: Wiley. Arthur, J. 2005. Morality and Moral Controversies. Upper Saddle River, NJ: Prentice Hall. Berg, P. 2004. Asilomar and recombinant DNA. 26 August. http://nobelprize.org/nobel_prizes/ chemistry/articles/berg/index.html. Cited 1 June 2007. Crichton, M. 2003. Prey. New York: Avon Books. Dyson, F. 2003. The future needs us! New York Review of Books 50: 2 (13 February). Editorial. 2003. Responding to “nanotech” concerns. Nature Materials 2.8: 499. Friedman, M. 1970. The social responsibility of business is to increase profits. The New York Times Magazine, 13 September 1970. Gregorian, V. 2005. The pursuit of knowledge. The Chronicle of Higher Education, 9 December 2005. Grunwald, A. 2005. Nanotechnology—a new field of ethical inquiry? Science and Engineering Ethics 11.2: 187–201. Hume, D. 2000. Treatise of Human Nature. Oxford: Oxford University Press, pp. 1739–1740. Joy, W. 2000. Why the future doesn’t need us. Wired. http://hotwired.lycos.com/wired/archive/ 8.04/ joy.html. Cited 1 April 2006. Kass, L. R. 2003. Beyond therapy: Biotechnology and the pursuit of human improvement. http://www.bioethics.gov/background/kasspaper.html. Cited 1 April 2006. Khushf, G. 2004. Systems theory and the ethics of human enhancement: A framework for NBIC convergence. Annals of the New York Academy of Sciences 1013: 124–149. Kuhn, T. S. 2000. The Road Since Structure: Philosophical Essays, 1970–1993, with an Autobiographical Interview, J. Conant and J. Haugeland, eds. Chicago: University of Chicago Press. Miller, S. 2004. How the legal system should change as a result of converging technologies. Annals of the New York Academy of Sciences 1013: 178–185. Muller v. Oregon, 208 U.S. 114 (1908). National Nanotechnology Initiative. 2000. http://www.wtec.org/loyola/nano/ NSET.Societal. Implications/nanosi.pdf. Cited 1 April 2006. Roco, M. 2004. Science and technology integration for increased human potential and societal outcomes. Annals of the New York Academy of Sciences 1013: 1–16. Schwartz, J. 2007. Of gay sheep, modern science and bad publicity. New York Times, 25 January 2007. Steinfels, P. 2001. Ethical limits on stem cell research. New York Times, 8 September 2001. http:// query.nytimes.com/gst/fullpage.html?sec=health&res=9B00E5D61E 39F93BA3575AC0A96 79C8B63. Cited 1 June 2007. Strohmenger, R. 2005. Gene therapy: After setbacks, projects move on. The Daily Pennsylvanian. http://www.dailypennsylvanian.com/vnews/display.v/ART/2005/02/08/420872fbc96d8. Cited 1 April 2006. Thompson, L. 2000. Human gene therapy, harsh lessons, high hopes. FDA Consumer Magazine, September–October 2000. Wilsdon, J. 2004. Nanotechnology, risk, and uncertainty. IEEE Technology and Society Magazine: 1. Wimsatt, W. 1980. Reduction research strategies and their biases in the units of selection controversy. In Scientific Discovery: Case Studies, vol. 2, T. Nickels, ed., Dordrecht: Reidel, pp. 213–259. Yardley, J. 2002. Michael Crichton’s nano war. Washington Post, 28 November 2002: C01.

Chapter 4

Ethics, Risk, and Nanotechnology: Responsible Approaches to Dealing with Risk1 Commission de l’Éthique de la Science et de la Technologie

4.1

Introduction

Nanotechnology arises from the convergence of basic research in physics, chemistry and biology, and is often considered one of the most promising technologies for the future of humanity. However, while the prefix “nano” has leaked into popular language, its very concept is still unclear to most people. Nanotechnology is innovative in character; it is currently moving from the laboratory to industrial manufacturing and marketing; significant public and private investments are going into development and promotion; and the anticipated benefits are considerable. For all of these reasons, the Québec Commission de l’éthique de la science et de la technologie (CEST) has decided to explore nanotechnology from an ethical perspective and to publish a position statement on the subject. For the purpose of a global reflection on nanotechnology, the Commission has deemed important to consider such aspects as the size of nanometric particles, the means of manipulating materials (top-down and bottom-up), multidisciplinary approaches and the convergence of disciplines with respect to nanotechnology as well as a general fascination with nanotechnology. These aspects provided the foundation of the ethical questions addressed by the Commission. The three chapters of its position statement are devoted to the scientific, legal and ethical implications of nanotechnology; the present paper is dedicated to the importance of the precautionary principle and of a life cycle approach in dealing with risks concerning nanotechnology, which is addressed in the second chapter. In its ethical assessment of nanotechnology, the Commission is upholding the protection of health and the environment, as well as respect for many values such as dignity, liberty, the integrity of the person, respect for the person, quality of life, respect for privacy, justice and equity, transparency and democracy. The Commission

1

This paper has been prepared by Diane Duquet and Emmanuelle Trottier. It is part of a Position Statement by the CEST (Quebec, Canada) published in November 2006: Ethics and Nanotechnology: A Basis for Action (available at http://www.ethique.gouv.qc.ca, English section). Translation made by Anglocom. The French version prevails.

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has formulated eight recommendations to political decision-makers and other interested parties. However, the Commission has sometimes found it impossible to make a specific recommendation on a given subject, even when it judged that subject to be important. In such cases, it has issued a commentary instead, in order to highlight the implications of a particular question so that Québec society as a whole may be in a better position to act and make informed decisions about nanotechnology. With nanotechnology, the Commission has discovered a scientific world that is fascinating, but also highly complex and scattered, particularly due to its multidisciplinary nature. It is also an emerging field that provides an opportunity to prepare for any problems technological innovation might bring, in order to offset or minimize certain adverse effects. At the same time, this new field also raises the question of uncertainty and ignorance regarding risk, as research is still limited.

4.2

Risk and Nanotechnology

Much like electricity and electronics before them, nanoscience and nanotechnology will impact on all spheres of daily life. A large range of applications has already been derived from nanotechnology,2 or may be derived from it in the future.3 These applications are sometimes puzzling, often fascinating and in some cases worrying. The four main sectors of research and innovation playing a major role in nanotechnology are nanomaterials, nanoelectronics, nanobiotechnology, and nanometrology. If nanotechnology fulfills current expectations, it could produce benefits in a multitude of areas from medicine to the environment, and from information technology to agriculture and food. Undoubtedly, the expected benefits are tremendous and could help solve many of the problems facing developed and developing contemporary societies. However, it is important to ask questions about the possible or hypothetical impacts of some innovations derived from nanotechnology or from its convergence with other disciplines. What kind of changes are anticipated or expected? How will nanotechnology innovation affect individuals—citizens, consumers, and workers— and society as a whole, not to mention future generations? Should adverse effects on health, the environment, or in other areas be anticipated in order to prevent them or keep them to a minimum? Problems encountered in recent years with asbestos, mercury, lead, DDT, freon, and recently teflon raise the question of the long term effects of new substances such as engineered nanomaterials and nanoparticles.

2 See list of the numerous products on the market compiled by the Woodrow Wilson Center for Scholars (2007). 3 The National Science and Technology Council (United States) published an interesting list in September 1999; see World Technology Evaluation Center (1999).

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Questions also persist about some of the possible aims of nanotechnology, particularly as regards physical or intellectual performance optimization in humans. Moreover, like other technologies that emerged in the second part of the twentieth century— particularly biotechnology, genomics, proteomics, and genetics—nanotechnology points to the need to resolve certain problems inherent to scientific and technological progress in democratic and pluralistic societies, including the issues of intellectual property and patent management, as well as the role of citizens in scientific decision making.

4.2.1

A Context of Uncertainty and Ignorance

Regarding risk, two factors are worth considering: the probability that an event will occur and the nature and significance of damages resulting from this event. Although these two factors are not always present in the case of nanotechnology, they still raise the questions of how to deal with scientific uncertainty, which in turn is related to the state of knowledge in this area as well as to ignorance about what could happen once a new technology is adopted. The concept of risk is highly prevalent in any assessment of the emergence of new technologies4 and even more when ethical issues are in question. Risk can essentially be defined as a “possible, uncertain event that can cause damage and is not solely dependent on a person’s desires.”5 Two factors must therefore be considered: the probability that a potentially harmful event will occur and the potential damage such an occurrence would cause (OECD, 2003, 30). These factors raise questions as to how to deal with scientific uncertainty tied to the state of knowledge in the field, as well as ignorance about what might happen after a new technology is implemented. As regards ethics—and without adopting a catastrophist approach—the hypothesis that an event with possibly harmful consequences might occur cannot be ruled out. It is in this spirit that the Commission speaks not only of “known risk” but also of “hypothetical risk”; it thus seeks to adopt an “all-encompassing” vision of risk that also considers the hypotheses and fears expressed, knowing that it is giving broader meaning to the word “risk”. The following aspects of nanotechnology should be highlighted in order to demonstrate the importance of better understanding and monitoring the risk it may entail: first, the key role of nanoparticles in the development of new nanotechnology applications—given the relatively well-known industrial hygiene, health, and environmental risks associated with fine and ultrafine (non-nanometric) particles released into the atmosphere—and second, the new properties materials can acquire at the nanoscale (e.g., toxicity, conductivity, reactivity).

4 5

On this subject, see, among others, OECD (2003). OQLF (2002) [our translation]

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4.2.2

The Nature of Risks to Consider

Like any other natural or industrial particles that present toxicity risks for living organisms, engineered nanoparticles (which are created voluntarily) also carry risks associated with their manipulation or their deliberate or accidental release into the air, soil, and water. These risks must be taken into consideration in order to protect workers, the public, and biodiversity as a whole: ●

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Risks tied to the manufacture, handling, transportation, storage, or elimination of potentially toxic or dangerous products; Risks that laboratory or industrial workers, or any populations who come into contact with toxic powders or products after their release into the air, water, or soil, will inhale or ingest these products or absorb them through the skin; Risks that products released into the air, water, or soil will contaminate flora or fauna; and Environmental and health risks tied to the reactivity of certain substances.

A number of existing statutes and regulations already address such risks with respect to products not derived from nanotechnology. But other risks, that research has not yet demonstrated, may specifically concern nanotechnology-derived products due to their particular characteristics (The Royal Society and the Royal Academy of Engineering [UK], 2005; SCENIHR, 2005): ●

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The clustering tendency of engineered nanoparticles and its potential effects on the environment and living organisms; The ratio of the specific surface of nanomatter compared to its mass, which modifies or intensifies the properties of the original material; The reactivity of certain nanometric particles, particularly metallic nanopowders, which can lead to explosion, flammability, or toxicity; and The ability of nanomatter to cross the cutaneous, pulmonary, intestinal, placental, and blood-brain barriers that protect human and animal organisms.

While there is still very little environmental and epidemiological data to support a process for assessing and managing the risk associated with nanotechnology-derived products, IRSST (a Québec research institute on occupational health and safety) believes it has been clearly demonstrated that the degree of toxicity of nanoparticles is tied to their specific surface and resulting new properties, not their mass (IRSST, 2006). Yet studies to date have focused more on mass than the surface area or size of the particles; certain authorities believe this could lead to gross underestimation of the potential risk of nanoparticles (IRSST, 2006). The specific surface and change in property of nanomaterials raise the question of the approval required to market new products. Are nanotechnology-derived or -transformed products considered new products? What about products whose risks are unknown or uncertain? Control agencies assess risk according to the nature and purpose of the product, not its manufacturing method or the possible transformation of its components. Can these processes take into account the specific features of nanotechnology-derived products or of a component nanometric

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transformation in an existing product (e.g., solar creams). It is important to note that such products are already on the market—the Woodrow Wilson Center database recorded over 380 in winter 20076—and more will be added with advances in research. Given that the passage of matter to the nanoscale can create changes in terms of both exposure (including the fate, persistence, and bioaccumulation of products in the environment or in living organisms) and the nature or intensity of possible adverse effects (SCENIHR, 2005, 54), how suitable are current assessment methods for nanotechnology-derived products and their impact on health and the environment? Lastly, the Commission takes into consideration that the effects of nanoparticles on health and the environment have been studied very little in the laboratory to date, particularly on humans, and the few research results obtained are sometimes contradictory and difficult to reproduce. Some believe that current equipment for measuring exposure to free nanoparticles is inadequate, as are assessment methods for determining the environmental fate of nanoparticles (SCENIHR, 2005, 4). In any case, the Commission considers the following issues crucial to assessing the risks associated with engineered nanoparticles, as proposed following a consultation by leading US organizations:7 ● ● ●

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Assessment of degree of exposure; Toxicity; The ability to extrapolate nanoparticle toxicity using non-nanometric particle and fiber toxicity databases; The environmental and biological fate, transportation, persistence, and transformation of nanoparticles; and The recyclability and overall sustainability of nanoparticles.

The Commission believes that the emergence of nanotechnology and the marketing of nanotechnology-derived products clearly pave the way for new health and environmental risk assessment methods.

4.3

Responsible Approaches to Dealing with Risk

Rarely has a society been able to consider the importance of monitoring the development of a new technology in the early stages of its emergence. While it certainly did not have the opportunity to do so with genomics, genetically modified organisms (GMO), and information and communications technologies, nanotechnology could be different. Should this technology be monitored and to what extent? Some hold

6 Woodrow Wilson Center for Scholars, 2007. Due to the collection method used—an Internet search for websites advertising products with nanotechnology-derived components—this list is incomplete, and the number of products in circulation is probably higher. 7 Results of a workshop organized by the National Science Foundation (NSF) and the US Environmental Protection Agency (EPA) cited in Dreher 2005. See also Luther (director), 2004.

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that legislation on nanotechnology is not necessary,8 others believe it is,9 and still others believe that imposing a moratorium on nanotechnology is the only possible solution.10 In the current state of affairs, the Commission considered two approaches to guide responsible development of nanotechnology: the precautionary principle and the “life cycle” approaches.

4.3.1

The Precautionary Principle as a Principle for Action

Considering the uncertainty and ignorance regarding the possible repercussions of nanotechnology on health and the environment, many writings on nanotechnology refer to the precautionary principle, generally to point out the lack of true consensus on its definition and the difficulty of implementing it without undermining scientific progress. There is no common position either regarding the role this principle should play in the risk analysis process (OECD, 2002). UNESCO suggests the following definition of the precautionary principle: “When human activities may lead to morally unacceptable harm that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish that harm.” (OECD, 2002, 14) Like most other definitions of the concept, this one is based on the text adopted at the June 1992 Earth Summit held in Rio: “Principle 15: In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.”11 Over the years, this definition has spread to areas other than the environment, particularly public health, and some clarifications should be made. Regardless of the definitions or terminology used, there is considerable confusion surrounding the principle with respect to the notion of risk (occurrence and consequences), as well as the distinctions to be made regarding the state of knowledge and among the notions of prudence, prevention, and precaution in decision making. This confusion also arises from prejudices that the precautionary principle is paralyzing and requires the demonstrated absence of all risk. For this reason, the Commission felt it necessary to provide an overview of the issue in the following paragraphs.12

8

This is the opinion of The Royal Society and the Royal Academy of Engineering (UK) (2005), whose authors nevertheless recommend vigilant monitoring of the technology’s evolution. 9 Among other possibilities, J. Clarence Davies of the Woodrow Wilson International Center for Scholars, proposes a set of measures, including a law on managing the risks associated with nanotechnology. See Davies (2006). 10 For example, as suggested by Canada’s ETC Group (Action Group on Erosion, Technology and Concentration), see ETC Group (2003). 11 United Nations, 1992. See text online at http://www.unep.org/ Documents.multilingual/Default. asp?DocumentID=78&ArticleID=1163, Cited 1 February 2007. 12 The reader is also invited to consult IÖW, 2004.

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Danger, risk, known risk, hypothetical risk. Danger is “exposure to possible evil, injury, or harm,” (Webster’s) while risk is “the possibility of suffering harm or loss; a factor, course, or element involving uncertain danger” (Webster’s). According to these definitions, it is possible to say that danger exists absolutely, in and of itself, while the possible occurrence of danger is what creates a risk. A known risk is one whose existence has been demonstrated; and, depending on the circumstances, its probability of occurrence can be calculated—from low to extremely high; never zero (Kourilsky and Geneviève, 1999)—or not (e.g., in cases of scientific uncertainty like avian flu). Hypothetical (or potential) risk is not demonstrated and may be impossible to demonstrate; its probability of occurrence cannot be calculated, but it is still plausible based on common sense or past experience (it does not arise from a foolish fear). In a certain sense, it is an affirmation that there is a risk that a risk exists—and that the feared event may never occur (optimistic attitude) or, at the other extreme, that it will almost certainly occur (catastrophist attitude). It should be pointed out that not all hypotheses have the same value, and just because a hypothetical risk exists does not mean it must be avoided at all costs (Hunyadi, 2005). Unreasonable, harmful, irreversible risk, or morally unacceptable danger. At the two extremes, the known or hypothetical consequences of a risk may be benign or deadly, with a whole range of possibilities between the two, from least to most harmful. According to UNESCO (COMEST, 2005), “morally unacceptable harm refers to harm to humans or the environment that is: threatening to human life or health; serious and effectively irreversible; inequitable to present or future generations; or imposed without adequate consideration of the human rights of those affected.” Of all the notions that define the precautionary principle, “unreasonable risk” is undoubtedly the most difficult to pin down, the most subjective, and the least tied to scientific expertise and mathematical quantification. How many lives must be sacrificed, how many workers must suffer from an occupational disease that reduces their life expectancy, how many animal or plant species must become extinct, what level of air, water, and soil pollution must be reached for a risk to be deemed unreasonable? Is irreversibility a criterion that can help answer all these questions and many other similar ones? Such concerns lead to the issues of risk perception and social acceptability, which, according to the OECD, call for “a consensual approach to the use of precaution in risk management, informed use of cost-benefit and decision analysis tools, and a participative-deliberative approach to decision making” (OECD, 2003)—an ethics-based approach, in some sense, since a moral judgment must be made regarding the acceptability of the risk according to socially shared values. State of knowledge: certainty, uncertainty, ignorance. Any decision to determine whether a risk exists and assess its probability of occurrence is rooted in the state of knowledge, i.e., information available about “the potential consequences of a product, process, or activity in order to take the necessary measures to prevent or minimize any damages linked thereto” (OECD, 2002). At a certain level of scientific advancement or technology development, research results are a significant source

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of accumulated knowledge on the subject and the possible positive or negative consequences of associated applications. But these results can also include incomplete, questionable, even contradictory information on certain research subjects, creating uncertainty in the determination of risk. Moreover, some research may never have been done or may be impossible for a number of reasons (limits in instrumentation, research and experimentation methods, the body of appropriate research, the use of human subjects, etc.), creating a zone of temporary or permanent ignorance in certain areas that makes it impossible to determine whether a risk exists in using the knowledge available at a given moment in the evolution of a technology. Prudence, prevention, and precaution. These very similar concepts are difficult to distinguish semantically, contributing to confusion and misunderstanding of the precautionary principle, i.e., knowing when prudence, prevention, or precaution are required and for which risks or hypothetical risks. For this reason and due to the numerous and sometimes conflicting points of view on the matter, the Commission uses the distinction established by Mark Hunyadi (2005), in the belief that it might foster responsible decision making: act with prudence for risks whose repercussions and probabilities of occurrence are known, take a preventive approach in situations of uncertainty, i.e., when the risks are known but their probability of occurrence is not (avian flu is an example of such a situation), and use precaution when there are only hypotheses and no information on the existence of a risk or its probability of occurrence, as with certain fears regarding an emerging technology like nanotechnology. Prejudices regarding zero risk and paralysis. Fears of the worst-case scenario and hopes of eliminating or preventing any danger that could harm health and the environment in the short, medium, or long term could prompt decisions aimed at taking no risks and rejecting any activities that could result in any risk whatsoever. Clearly, such a position can be unjustifiable and lead to aberrations: No technological progress would have been possible over the centuries, and life itself would be impossible if no risk were allowed. On the other hand, would this position have helped prevent problems like bovine spongiform encephalopathy (mad cow disease), or those caused by asbestos, DDT, teflon, and many others?13 Instead of seeking to avoid all risk, the question is probably how to determine which risks are acceptable. What adverse effects might a risk have? What is their scope and magnitude? What is the probability?14 Yet it is difficult to answer these questions with respect to hypothetical risks, since they involve ignorance and sometimes irrational fears. Does this mean that fear and the lack of an answer should lead to abstention? Is imposing moratoriums the only possible option? What avenues are possible to ensure that the precautionary principle leads to action?

13

These and other similar cases were studied under the auspices of the European Environment Agency and the results published in Institut français de l’environnement, 2004. 14 On this subject, see, among others, OECD, 2002, 18.

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A principle for action. As noted by Olivier Godard (2005), “the original contribution of the precautionary principle is that it sets out a requirement for early responsibility (in scientific time) for hypothetical, unproven risks that could have serious and irreversible consequences; such risks theoretically fall outside the prevention principle, which concerns risks that have been proven by scientific knowledge or experience.” This discussion of the precautionary principle and the desire to make it a principle for action, rather than abstention, raise many questions, including the following: How can hypothetical risks be managed in a pluralistic and democratic society? How can society take into account the differing degrees of acceptability between individual and collective risk, and between health and environmental safety requirements on the one hand and the legitimate desire for technological development on the other? In the Commission’s view, this subject deserves to be debated in society. In the meantime, however, both to guide and spur this debate, as well as enable a responsible development and use of nanotechnology, the Commission offers a few observations and possible solutions. Observations to consider. The following observations are provided as a guide in order to promote the adoption of realistic and responsible measures for decision making regarding the known and hypothetical risks of nanotechnology: ●

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Due to the radically new challenges certain emerging new technologies may pose (including nanotechnology and biotechnology) and the transformation of regulatory methods in contemporary society, as well as the diversity of stakeholders in the context of globalization, “novel risk situations might be met with excessive inertia or inappropriate institutional responses […]” (OECD, 2003, 48); Risks must increasingly be considered as potential due to their newness in emerging technologies; risk management should therefore be based more on the evolution of technology rather than historical records of past risks (OECD, 2003, 49), while keeping in mind that relatively minor incidents could have disastrous effects after many years (OECD, 2002, 6) (asbestos is a noteworthy example); Considering that zero risk does not exist, decision makers are not expected to ensure a totally risk-free environment; however, they must keep in mind potential scientific uncertainty and ignorance with respect to hypothetical risks and take responsible measures, including precaution (OECD, 2002, 29 and 30); Considering the societal aspects of risk is essential, and acceptability is a key notion in the risk assessment and management process (OECD, 2003, 89); in view of this, the precautionary principle “imposes a clear need to improve communication and reflection on various levels and types of uncertainty in scientific assessment” (COMEST, 2005, 35); and The precautionary principle is not a substitute for scientific risk assessment, and it is not an alibi for circumventing agreements on free trade (OECD, 2003, 17).

To round out these observations indicated in the sources consulted, the Commission feels it should mention the importance of considering, from an ethical perspective, the potential consequences of refusing to accept a measure of risk, particularly as regards the meaningful benefits to the public that could result from nanotechnology advances.

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Examples of precautionary measures. The measures to be considered are “interventions undertaken before harm occurs that seek to avoid or diminish the harm. Actions should be chosen that are proportional to the seriousness of the potential harm, with consideration of their positive and negative consequences, and with an assessment of the moral implications of both action and inaction. The choice of action should be the result of a participatory process.” (COMEST, 2005, 14) These measures can differ, may be applied simultaneously or successively, if need be, and are therefore not mutually exclusive. In the spirit of its position statement, which limits use of the precautionary principle to situations of ignorance or considerable uncertainty, the Commission points out the following measures aimed primarily at managing such situations: ●

●

●

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Promote research as essential to countering ignorance and considerable uncertainty; while research is multidisciplinary, due to the very nature of nanotechnology it must also be interdisciplinary in order to bring together different areas of knowledge, including the social and human sciences; Use citizen participation and consultation mechanisms to determine the social acceptability of hypothetical or known risks with a high degree of uncertainty; Develop methods for controlling and monitoring research results and incidents— even minor—in order to promote the early detection of potentially dangerous or harmful situations; and Enact legislation to impose the necessary prohibitions and restrictions, including moratoriums on certain practices.

In its position statement, the Commission has discussed certain ethical issues relating to nanotechnology and indicated some ignorance or considerable uncertainty regarding the possible effects on health and the environment, particularly with respect to nanoparticles; it issued recommendations to the various stakeholders based on the observations and action steps indicated above (see Appendix 3).

4.3.2

The “Life Cycle” Approach from the Perspective of Sustainable Development

In 1997, the ISO 14040 (from the 14000 series15) international standard on life cycle assessment for environmental management was adopted. The following year, Environment Canada (2003) published a guide entitled Environmental Life Cycle

15

Readers should note that “the main purpose of the ISO 14000 series standards is to promote more effective and efficient environmental management in organizations and the provision of useful and usable tools (cost-effective, systems-based, flexible, based on the best organizational practices available) for gathering, interpreting, and communicating environmentally relevant information, the end result of which should be the improvement of environmental performance.” See International Standards on Environmental Management Systems, 1996.

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Management: A Guide for Better Business Decisions, including the following definition: “[The life cycle concept takes] a ‘cradle to grave’ approach to thinking about products, processes, and services. It recognizes that all product life cycle stages (extracting and processing raw materials, manufacturing, transportation and distribution, use/reuse, recycling, and waste management) have environmental and economic impacts.” There is clearly international interest in considering the issue of life cycle with respect to nanotechnology. Examples of this include the European Union’s sixth framework program (European Union, 2002), the joint report by the Royal Society and the Royal Academy of Engineering in Great Britain (2005), a draft white paper by the US Environmental Protection Agency (EPA),16 and a briefing by the California Council on Science and Technology (2004). In this briefing, however, interest in product life cycle is primarily tied to the industrial production of nanometric components, particularly as regards worker and environmental protection, since nanocomposites may accumulate in the environment over time: It is the transition to large-scale commercial manufacturing of these materials that is the primary concern, not the small amounts of material produced in the research process. The exposure of workers to nanoparticulates will require investigation, and potential regulation as with chemicals found to be hazardous but useful. With large production quantities, it will also be important to study the full life cycle of these materials, including the associated process of producing them, their use, and eventual disposal. Nanocomposites, for example, may be more difficult and more energy-intensive to recycle than single-phase material, and may accumulate in the environment over time. Since environmental impacts may be slow to develop and ascertain, one of the challenges will be to determine what needs to be monitored over the course of time as an important and relevant effect. (California Council of Science and Technology, 2004, 108)

Such concern is increasingly obvious with respect to sustainable development, as can be seen in the new Sustainable Development Act (Gouvernement du Québec, 2006) adopted by the Québec Government in April 2006. Whether with regard to life cycle thinking (Belem, 2006) or the life cycle approach (Interuniversity Research Center for the Life Cycle of Products, Processes, and Services [Ciraig], 2005) or, more concretely, life cycle management (Interuniversity Research Center for the Life Cycle of Products, Processes, and Services [Ciraig], 2005) or life cycle assessment (Interuniversity Research Center for the Life Cycle of Products, Processes, and Services [Ciraig], 2005; Belem, 2006,) (LCA), the basic goal is to protect the environment by taking into account the impact of “cradle-to-grave” technological innovation, i.e., from the time the resources required to manufacture a product are obtained to final disposal of the product at the end of its useful life (The Royal Society and the Royal Academy of Engineering [UK], 2005, 32).

16

Environmental Protection Agency ([EPA] United States), 2005. This draft has been followed by the U.S. Environmental Protection Agency Nanotechnology White Paper in February 2007, http:// www.epa.gov/osa/pdfs/nanotech/epa-nanotechnology-white-paper-final-february-2007.pdf, Cited 1 March 2007.

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The Commission refers to the concept of sustainable development as presented in Québec’s Sustainable Development Act, “development that meets the needs of the present without compromising the ability of future generations to meet their own needs. [It] is based on a long term approach which takes into account the inextricable nature of the environmental, social, and economic dimensions of development activities.”17 As indicated in a consultation paper released prior to adoption of the act (Gouvernement du Québec, 2004), “this definition draws on the following: ●

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The idea of intergenerational equity from the initial definition in the Brundtland Report; The idea of improved living conditions from the enhanced definition issued in 1991 by IUCN, UNEP, and WWF; and The international consensus that the environment, society, and the economy should be the three fundamental dimensions of sustainable development.”18

In its Position Statement, the Commission recommends that the Québec Government, guided by the precautionary principle and from the perspective of sustainable development, be concerned with all phases of the life cycle of a product derived from nanotechnology or containing nanometric components. The Commission also asks that, in this respect, the Government integrate the concept of “life cycle” into all policies where such an approach is appropriate, in order to avoid any damaging impact of technological innovation on health and the environment.

4.4

Conclusion

The fact that nanotechnology is still an emerging technology means that it is impossible today to predict all the applications that are to come and what repercussions these applications could have in the future. By way of illustration, consider the emergence of the Internet, which has revolutionized communications and had a profound affect on the way people live. Who could have predicted this technology would have such a deep cultural impact when it was developed over 30 years ago by a computer science professor with grants from the US Department of Defense? The same goes for nanotechnology. The Commission feels that nanotechnology’s potential impact cannot be minimized and that caution must therefore be used in implementing the measures needed to ensure responsible management thereof. In support of this assertion, the Commission has given in its statement examples of applications in the health, environment, and security sectors that boast laudable goals, but that could also have

17 18

Section 2 of the Sustainable Development Act, Gouvernement du Québec, 2006. Gouvernement du Québec, 2004 [our translation].

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potentially harmful indirect consequences. It has further provided several examples that show how the peaceful use for nanotechnology could be diverted from its original altruistic or protective purposes and instead be used to aggressive ends of potential danger to humankind. The potential for modifying human behavior, monitoring people without their knowledge, or releasing harmful substances into the environment must spur those involved in promoting nanotechnology and producing nanotechnology-derived products to act responsibly and transparently. However, the Commission also feels that one should not assume that nanotechnology can only lead to doom and ruin. Undue apprehension could result in the untimely demise of budding technologies with extremely positive potential—if used properly. Improving human health through early disease detection and targeted therapy, restoring habitats damaged by human actions, and making more effective use of available resources are just a few examples of the possible positive contributions nanotechnology could make. Nevertheless, those involved in nanotechnology must be willing to discuss the objectives being pursued and the actions to take for these benefits to be enjoyed by a vast majority, because it is often society as a whole that must deal with the consequences. Hence the importance of adopting responsible and ethical approaches toward the development and implementation of nanotechnology, such as the precautionary principle and life cycle approaches.

References Belem, G. 2006. L’analyse du cycle de vie comme outil de développement durable. Under the direction of Jean-Pierre Revéret and Corinne Gendron, Les cahiers de la Chaire, research collection, Chair of Social Responsibility and Sustainable Development. No. 08-2005. http:// www.crsdd.uqam.ca/pdf/pdfCahiersRecherche /08-2005.pdf. Cited 1 February 2007. California Council of Science and Technology. 2004. Nanoscience and Nanotechnology. Opportunities and Challenges in California, A Briefing for the Joint Committee on Preparing CA for the 21st Century. January 2004. http://www.larta.org/lavox/articlelinks/2004/040223_ nanoreport.pdf. Cited 1 February 2007. CEST. 2006. Ethics and Nanotechnology: A Basis for Action. http://www.ethique.gouv.qc.ca, English section). Translation made by Anglocom; the French version prevails. Commission de l’éthique de la science et de la technologie. 2006. Ethics and Nanotechnology: A Basis for Action. Québec. http://www.ethique.gouv.qc.ca (English section). Davies, J. C. 2006. Managing the Effects of Nanotechnology. Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies; Washington, DC. 27 January 2006. http:// www.wilsoncenter.org/events/docs/ Effectsnanotechfinal.pdf. Cited 1 February 2007. Dreher, K. L. 2005. Toxicological Highlight. Health and Environmental Impact of Nanotechnology: Toxicological Assessment of Manufactured Nanoparticles. Toxicological Sciences 77.1: http://171.66.120.171/cgi/content/full/77/1/3. Environment Canada. 2003. What is Life Cycle Management? http://www.ec.gc.ca/ecocycle/en/ whatislcm.cfm. Cited 1 February 2007. Environmental Protection Agency (US). 2005. External Review Draft. Nanotechnology White Paper. Science Policy Council, Washington, DC. 2 December 2005. http://www.epa.gov/ osa/pdfs/EPA_nanotechnology_white_paper_external_review_draft_12-02-2005.pdf. Cited 1 February 2007.

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Environmental Protection Agency (US). 2007. Nanotechnology White Paper. February 2007, http://www.epa.gov/osa/pdfs/nanotech/epa-nanotechnology-white-paper-final-february-2007. pdf. Cited 1 March 2007. ETC Group. 2003. No Small Matter II: The Case for a Global Moratorium. Size Matters! Occasional Paper Series 7.1: http://www.etcgroup.org/upload/publication/ 165/01/occ.paper_ nanosafety.pdf. Cited 1 February 2007. European Union. 2002. Sixth Framework Program: Nanotechnologies and Nanosciences. http:// europa.eu/scadplus/leg/en/lvb/i23015.htm. Cited 1 February 2007. Godard, O. 2005. Le principe de précaution et la proportionnalité face à l’incertitude scientifique. Rapport public 2005: jurisprudence et avis de 2004. Responsabilité et socialisation du risqué. Conseil d’État, Paris, La Documentation française, 385. Gouvernement du Québec. 2004. Source d’information sur les organismes genetiquement modifies. http://www.ogm.gouv.qc.ca (in French only). Cited 1 February 2007. Gouvernement du Québec. 2006. Sustainable Development Act, R.S.Q. c. D-8.1.1. http://www. iijcan. org/qc/laws/sta/d-8.1.1/20060525/whole.html. Cited 1 February 2007. Gouvernement du Québec. 2007. Plan de développement durable du Québec. November 2004. http://www.mddep.gouv.qc.ca/developpement/2004–2007/plan-consultation.pdf. Cited 1 February 2007: 19 Hunyadi, M. 2005. Qu’est-ce que le principe de précaution? Nouvelles réflexions sur les usages du PP. Speaking notes from a seminar on the precautionary principle to the Commission de l’éthique de la science et de la technologie, 4 November 2005: 8. Institut de recherche Robert-Sauvé en santé et en sécurité du travail (). 2006. Health Effects of Nanoparticles, Claude Ostiguy et al. Report R-469, Studies and Research Projects. Gouvernement du Québec. August 2006. http://www.irsst.qc.ca/en/ _publicationirsst_100209. html. Cited 1 February 2007: 43. Institut français de l’environnement. 2004. Signaux précoces et leçons tardives: le principe de précaution – 1896–2000. Orléans. http://www.developpement.durable. sciences-po.fr/publications/ Bibliographies/signaux_precoces.pdf. Cited 1 February 2007. Institut für Ökologische Wirtschaftsforschu (IÖW). 2004. Nanotechnology and Regulation within the Framework of the Precautionary Principle, Final Report. Rüdiger Haum et al. Berlin, February 2004. Interuniversity Research Center for the Life Cycle of Products, Processes, and Services (Ciraig). 2005. Mémoire. As part of consultation on the draft Québec Sustainable Development Plan and the draft Sustainable Development Act, February 2005. http://www.polymtl.ca/ciraig/ Memoire_CIRAIG _DD.pdf. Cited 1 February 2007. International Standards on Environmental Management Systems. November 1996. http://www. intracen.org/tdc/Export%20Quality%20Bulletins/eq53eng.pdf. Cited 1 February 2007: 2–3. Kourilsky, P. and Geneviève, V. 1999. Le principe de précaution, report to the prime minister, Paris, 15 October 1999. http://www.ladocfrancaise.gouv.fr. Cited 1 February 2007: 5. Luther, W. (director). 2004. Industrial Application of Nanomaterials: Chances and Risks. Technological Analysis, with the Support of the European Commission. http://www.vdi.de/ vdi/organisation/schnellauswahl/techno/arbeitsgebiete/zukunft/sub/10803/index.php. Cited 1 February 2007. Organization for Economic Cooperation and Development (OECD). 2003. Emerging Risks in the 21st Century: An Agenda for Action, Paris. Office québécois de la langue française (OQLF). 2002. Le grand dictionnaire terminologique. http://www.oqlf.gouv.qc.ca/ressources/gdt.html. Cited 1 February 2007. Organization for Economic Cooperation and Development (OECD). 2002. Uncertainty and Precaution: Implications for Trade and Environment. Joint Working Party on Trade and Environment. 5 September 2002. http://www.olis.oecd.org/olis/2000doc.nsf/ 4f7adc214b91 a685c12569fa005d0ee7/98a7c482 bccb43 afc1256c2b003fe2ce/$FILE/ JT00130913.PDF. Cited 1 February 2007: 14. Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). 2005. Opinion on the appropriateness of existing methodologies to assess the potential risks associated

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with engineered and adventitious products of nanotechnologies, European Commission. September 2005. http://files.nanobio-raise.org/ Downloads/scenihr.pdf. Cited 1 February 2007. The Royal Society and the Royal Academy of Engineering (UK). 2005. Nanoscience and Nanotechnologies: Opportunities and Uncertainties. London, The Royal Society. July 2004. http://www.royalsoc.ac.uk/document.asp?id=2023. Cited 1 February 2007. United Nations. 1992. Rio Declaration on Environment and Development. http://www.unep.org/ Documents.multilingual/Default.asp?DocumentID=78&ArticleID=1163. Cited 1 February 2007. Woodrow Wilson Center for Scholars. 2007. A Nanotechnology Consumer Products Inventory. http://www.nanotechproject.org/index.php?id=44. Cited 1 February 2007. World Technology Evaluation Center. 1999. Nanotechnology Research Directions: IWGN Workshop Report. September 1999. http://www.wtec.org/ loyola/nano/IWGN.Research.Directions/IWGN_ rd.pdf. Cited 1 February 2007. World Commission on the Ethics of Scientific Knowledge and Technology (COMEST). 2005. The Precautionary Principle. Paris: UNESCO. http://unesdoc.unesco.org/images/0013/ 001395/139578e.pdf. Cited 1 February 2007: 14.

Chapter 5

Intuitive Toxicology: The Public Perception of Nanoscience1 David M. Berube

5.1

Introduction

“Intuitive toxicology” is much more than a clever term. It refers to how an inexpert or lay audience comprehends and reacts differently to expert information, in this case quantitative toxicology data. There is a tyranny of risk assessment and management in policy making. Experts solicit and collect data on hazards based on in vitro and in vivo studies. They pair these findings to dosage and exposure information of all sorts, some based on observation and others on supposition. In turn, they develop a risk assessment. Next, we have risk management. Having determined that a hazard is present, experts suggest better or even best practices be adopted to reduce exposure or if that is impractical, to avoid the hazard altogether. Having reduced the risks involved, experts assume the people affected will react rationally and applaud the experts for their hard work and live their lives a little safer. Risk management is essential to protect workers when producing potentially hazardous products, including nanoparticles. However assessment data sets are not perceived persuasively by lay persons (hereafter referred to as “the public”). In addition to the insufficient life cycle risk assessment which places in question current risk assessments, there are clear routes of exposure which may directly impact the public. The public may be exposed to acute and especially chronic toxicological effects from many applications of nanoscience, such as cosmetics and food products. In addition, health professionals intend to use nanotechnology to detect, diagnose, image, and treat a number of physical disorders which may expose the public to nanoparticles as well. The public will be affected on some level.

1 This work is supported by grants from the National Science Foundation, NSF 01-157, Nanotechnology Interdisciplinary Research Team (NIRT) – “Philosophical and Social Dimensions of Nanoscale Research, From Laboratory to Society: Developing and Informed Approach to Nanoscale Science and Technology” and NSF 05-543, Nanotechnology Undergraduate Education (NUE) – “Nanoscience and Technology Studies Cognate”. All opinions expressed are the author’s and do not necessarily reflect those of the National Science Foundation, the University of South Carolina, neither its NanoCenter nor its NanoSTS team, or North Carolina State University.

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Risks are perceived and if the public as citizens and consumers are to react favorably to the introduction of nanotechnology into the market, their perceptions of the risks associated with applied nanoscience is important. While protecting the health and safety of workers when making products involving nanoparticles is incredibly important, the citizen consumer has been poorly addressed. It is important for standard risk assessments to continue, but it is equally important that parallel to these efforts we engage public risk perception and design communication strategies appropriate to the task at hand. The problem for experts, regulators, business and industry, and policy makers is that the public uses a non-rational calculus based on a matrix of attitudes and beliefs (hereafter referred to as “values”) to decide risk issues and current risk assessment algorithms used by risk management professionals do not include these non-rational variables. For example, “…the public reliably perceives a negative relationship between hazards’ risks and benefits, despite there being no relationship or, if anything, a positive relationship between many hazards’ risk and benefits in the external environment” (Finucane 2001). The reliability of this phenomenon provides hope to the risk communicator. The public is not acting irrationally, they are acting non-rationally and non-rational calculi can be represented algorithmically. Given one of the first hurdles confronting the world in applied nanoscience may involve human and ecological toxicity, we must develop a procedure or a set of procedures that will help the public to decide whether the nascent industry is acting in the public interest and this may include more creative and sustained efforts toward public inclusion. The public must be able to take information and draw their own conclusions since top-down and linear models of communication involving risk tend to fail. In addition, this process becomes very complicated when intermediaries become involved, such as non-governmental organizations and the media. However, once we establish some baseline data and employ a series of models that take full advantage of risk perception research on nanotechnology, we will be able to better understand the phenomena at play and may be able to build communication algorithms that may be amenable to all parties involved.

5.2

The Case of Applied Nanoscience

Nanotechnology has demonstrated great promise in many areas. For government and industry to continue to research and develop new products, the public will need to support government spending, buy consumer products, and accept the net benefits of nanotechnology. Teams of stakeholders, including regulators, industry, academia, and others, will need to be in the forefront of efforts to communicate risk information about nanotechnology. We have learned over and over again the media can both amplify and attenuate technological events and associated risk values. For example, to date the media and others have associated nanoscience and concepts and events that already carry a

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high negative valence, such as the GMOs marketing disaster in Western Europe, Africa and Asia. Furthermore, when searching for an analogue to describe some of the toxicological concerns associated with nanoparticles, references to asbestos and Alzheimer’s disease flourish in the media. In general, the media has demonstrated a propensity for exaggeration and hyperbole as a means for increasing readership and viewership. Depending on the media to portray the objective risk values associated with nanotechnology is a fool’s game, especially when what we think we know about the media may have changed as the media has evolved tremendously over the last decade. What is it about applied nanoscience which is especially troublesome to risk communicators? While it may not be necessary to proverbially reinvent the wheel when it comes to communicating risks about nanotechnology to the public, it might be fortuitous to do more than march out formulas which have had limited success in the past. Here are five of the most important reasons risk communicators may find communicating about the risks of applied nanoscience challenging. First, as I and others have argued before, applied nanoscience or nanotechnology is a general purpose technology akin to plastics. John Roach made the same observation in 2005. In 2006 the Guy Carpenter group used the metaphor in an insurance report on nanotechnology as well. As such, nanotechnology is ubiquitous and risk values must be associated to specific applications rather than drawn from the entire set of all things “nano”. A plastic bumper is much less a toxicological problem than latex gloves or even cellophane dry cleaning bags. As such, there are few, if any, standards for establishing comprehensive risk values in this instance. Second, as I have mentioned before, there is no nano-industry per se. The field is highly dispersed and companies are generally associated with very specific applications demanding different contributions from nanoscience. At best, it might be possible to categorize some of the industries and allow risk banding to occur (setting some risk estimates with some applications by some industries). For example, nanotitania used in cosmetics might share a similar toxicological signature regardless of the specific companies’ formulations. Nonetheless, broad conclusions about communicating nanotechnology associated risks may be a pipedream. Third, there is a unique level of misinformation. Many scientists claim there is nothing new about nanoscience per se. Rather, it is just the next phase in chemistry made possible by the discovery of the scanning tunneling microscope. At the same time, promoters continue to tout the remarkable or revolutionary advances which could be ushered in by nanoscience. We know nanoparticles have incredibly high levels of bioavailability and special quantum level effects associated with their size. This hyperbole is endemic. As such, there is a seemingly problematic inconsistence whence something not entirely revolutionary but evolutionary produces revolutionary rather than evolutionary results. Fourth as mentioned briefly above, there is the uncertainty over when a product with the nano-moniker actually uses nanoparticles. One of the more interesting cases involved Kleinmann’s product, Magic Nano. It turned out the product did not contain nanoparticles. At most, it was argued the film produced by the sealant, meaning the surface layer, laid down when used properly had a nano-sized thickness.

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In another case, there is disagreement to date on whether the process used in Samsung’s washers produces nanoparticles of silver at all. And the list continues. While there seems to be only one reported instance, involving NanoTex, where a decision was made to rescind the nano moniker from a product line, there are many more cases of the reverse. “Nano” remains a marketing term that adds value to a brand name. By reducing the size of particles, a product can be remarketed as enhanced and improved and the prefix “nano” becomes the advertising tag. Fifth, there has been remarkable developments in reportage marshaled in by the new media (cable, satellite, and web-based) which made substantial inroads into how all events are reported. This transformation occurred at nearly the same time that nanotechnology became prominent as a quasi-popular or semi-public phenomenon. The interplay between these two events has made accurate communication over risk much more complicated and challenging. For these reasons and others, communicating about “nano” to the public has become more difficult than anyone might have anticipated it to be. While we can draw from past experiences, communicating “nano” seems to require a rethink.

5.3

On Intuitive Toxicology

The term intuitive toxicology was first used by Neil et al. (1994) and Slovic et al. (1995) when they examined both expert and public judgments of chemical risks in the USA and in Canada. Sunstein (2002) used the term as well in his book Risk and Reason. “Intuitive toxicology refers to the assignment of risk which involves biases that may exclude both probabilities and assessments of hazards quantified by empirical research” (Berube 2006a, 302). For example, in many cases the public has relied on their senses in determining risk. A disturbing example involved the workers at Bhopal when they contextualized the technology that ravaged the city. Workers responded to malfunctions of the valve and alarm system by relying on their sense of smell. “Tragically, this early warning mechanism proved completely ineffectual against the runaway reaction that precipitated the disaster” (Jasanoff 1993, 126). Put simply, different assumptions, conceptions, values, and so forth underlie the discrepancy between experts and public views about chemical risks. Whether one of our primary senses is involved or not, the public seems to perceive risks intuitively rather than objectively. Let us return to nanotechnology. There is a growing body of research indicating that inhalation of nanoparticles may be problematic in terms of lesions in the lung and transportation of particles to other parts of the body, such as the brain or even mitochondria in cells, where free radicals may cause additional problems. The ingestion of nanoparticles associated with nano-pharmaceuticals, food additives, and so on provides an additional exposure route. There is even some evidence suggesting topically applied nanoparticles, such as nanotitania, might pass through the dermis and affect the circulatory and lymphatic systems. In addition, there is growing evidence some nanoparticles might be toxic to bacteria and small life

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forms at the bottom of the aquatic food chain as well as larger species, such as fish. We know very little about life cycle implications, from the waste stream issues associated with production to the disposal implications of nanoparticles embedded into other materials, such as from incineration (see Berube 2006a, chapter 6). One of the first major hurdles for applied nanoscience will involve resolving some of the toxicological challenges. While free nanoparticles seem more problematic that nanoparticles in a matrix, we are not yet able to guarantee, once embedded, they will remain so through the life cycle of the product, hence public exposure is not foreclosed. More importantly, intentional consumption of nanoparticles through ingestion or injection, etc. could expose the public even more so. As such, a better understanding of how to communicate with the public and how to enhance their understanding of concerns about the toxicity of nanoparticles is called for, especially given apprehensions expressed by many critics that should a nano-product prove dangerous, a contagion phenomenon may occur affecting other nano-products souring consumer interest (see Siegrist et al. (2007). Justified or not, a crisis of this sort could be amplified by the media and even some public interest groups which might threaten continuing public financial support for government related support for research and development in nanotechnology.

5.4

On Public Perception

Kahan et al. made the case for risk perception research in 2006. “The study of risk perception [is] a policy science of the first order…. [N]o one who aspires to devise procedures that make democratic policymaking responsive to such information can hope to succeed without availing [themselves] of the insights this field has to offer” (1072). One of the major challenges confronting risk communicators is convincing experts while “danger is real, risk is socially constructed” (Slovic 1999, 689) and not taking public sensibilities seriously adds to their anxiety and confusion. The public believes contamination is greater now than ever. In addition, for chemicals at least, many believe it can never be too expensive to reduce the risks (Kraus et al. 1992, 220). Scholarship in this area has been divided into two main camps: a psychometric approach (Fischoff et al. 1978) and a cultural approach (Douglas & Wildavsky 1982). The cultural approach includes the traditional world views approach associated with Douglas and Wildavsky and an ideological view approach with Dake (1991), an elite groups approach with Rothman and Lichter (1987), and a cultural cognition approach with Kahan et al. (2006). Others, especially Sjöberg (1998), claim none of these theories can adequately explain risk determinations and variance and a combination of these theories may explain best the phenomenon of risk perception. “Risk perception by the public can be said to be built upon a kind of metajudgment of risk, i.e. their judgment of what the experts say” (Sjöberg 1999a, 6). Research tends to support the conclusion that the public has a more multidimensional risk perception when many qualitative factors enter into their determinations.

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The data and information from experts and the media are decoded by the public using an algorithm that was not used by the experts when encoding the information. For example, Alhakami and Slovic (1994) found acceptability generally increased with increased benefit unless the risk was low (1091) leading one to conclude “…it might be possible to change perceptions of risk by changing perceptions of benefits…” (1096). This has led to public relations like campaigns touting the benefits of nanotechnology. Festooned with hyperbole and establishing false expectations coupled with the release of hardly sensational applications, such as pants and bowling balls, this approach is proving overly optimistic. Experts complain about the public’s risk algorithms. “The greatest risk to the public’s health may be its own risk assessment…. The same mechanisms that cause members of the public to form exaggerated perceptions of risk will also prevent them from processing scientifically sound information in a rational way” (Kahan et al. 2006, 1081), nevertheless, risk experts have not incorporated non-rational variables into their risk calculi and they abound. For example, Chauncey Starr (1969) found that voluntariness of exposure was the key mediator in risk perception with other characteristics such as familiarity, equity, level of knowledge, risks to future generations, etc. important as well. These primary variables relate to personal and scientific knowledge but also include a set of heuristics and biases. Individual characteristics, such as past experience with the hazard or specific technical knowledge can affect the importance of some dimensions and result in quite different judgment of risks (Savadori et al. 2004) as well. Other studies on public risk perception have identified biases such as catastrophic potential, vividness of the effects, and personal susceptibility (Slovic et al. 1979, Flynn et al. 1993, Sparks & Shepherd 1994, and Kletz 1996). Other factors include outrage, stigma, dread, and a list of biases such as affect, availability, loss aversion, status quo partiality, postdecisional regret aversion, etc. People interpret a given set of facts about risk with a host of these variables. They are not irrational to them. This matrix of variables, axiologies of values and beliefs, are supplemented by biases, epiphanies, prior experience, and so forth. Slovic attributes the public’s reaction to risks “…to a sensitivity to technical, social, and psychological qualities of hazards that were not well-modeled in technical risk assessments” (1993, 675), nonetheless a revolution in risk assessment design does not seem forthcoming at this time. Realistically, most citizens do not have access to scientific information upon which to make risk decisions. Others do not have the inclination. This has led some experts to advance public science education as a solution. Aggressive public science education, while meritorious for many reasons, remains insufficient. “Scientific literacy and public education are important, but they are not central to risk controversies” (Slovic 1999, 689) because the public does not seem to accord extraordinary weight to technical analyses (Jenkins-Smith & Silva 1998). While there may be a subtle link between the two, “…the link between technical knowledge and perceived risk [by the public] is at best variable” (Johnson 1992). Furthermore, the public seems particularly vulnerable to the maximin or minimax bias (Berube 2000). Low-probability-high-consequence events are exaggerated.

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For example, events associated with mortality or morbidity occurring within a few days and were thus more noticeable are assumed more risky than the same or more instances spread over a longer period of time. Many studies have found that this public perception is heavily weighted in favor of catastrophic accidents. This phenomenon has been associated with probability neglect whereby the public focuses on the worst case scenario. “This is largely due to news media coverage, which gives infinitely more attention to low-probability-high-consequence events than to frequently occurring, unspectacular or even undetectable events which accumulatively do must more damage to human health” (Cohen 1985, 2). The consequences of this set of biases lead “citizens…to support expensive preventative measures, however remote the risk and however cost-ineffective the abatement procedures” (Kahan et al. 1077). What’s more, tampering with nature which includes such aspects as immoral risk, human arrogance, and interference with the processes of nature seems to be a dominant bias as well (Sjöberg 1999a, 2002) in risk estimation. In general, this ecological fallacy is demonstrated when the same chemical appearing in nature is assumed more risky when produced by an industrial process (Slovic et al. 1995, McDaniels 1997). Tampering with nature seemed to be very relevant in terms of biotechnology and food related risk perception (Slovic et al. 1995, 662) for many reasons not the least of which are dependency on food, noxious food hazards may not be apparent, unfamiliarity with scientific labels, and so forth (Frewer et al. 1997, Fife-Schaw & Rowe 1996).

5.5

On Experts and the Public

Although claims that expert judgment is more veridical than the public’s are not examined here, the majority of the research indicates the public determine risks differently from experts. For a minority view, see Rowe and Wright (2001). Less drastic in tone Sjöberg (1999b) claims people are not that misinformed about all risks and cites some studies of illnesses showing convergence of expert and public opinion (Wyler et al. 1968). Nonetheless, these findings are exceptional to prevailing sensibilities. The vast preponderance of studies document differences between experts and the public in the perception of risk (Slovic et al. 1995, 1979; Slovic 1987; and Kraus et al. 1992). For example, we know the public ranks some risks higher, such as chemical products (Kraus et al. 1992 and Slovic et al. 1995), radioactive waste disposal (Kletz 1996), and spray cans (Slovic 1987). On the other hand, the public ranks some risks lower than experts, such as X-rays (Slovic et al. 1979 and Slovic 1987), downhill skiing (Savadori et al. 1998), and bicycles (Slovic 1987). While Drottz-Sjöberg and Sjöberg (1991) argue differences may exist before scientists receive their education (scientists self-select themselves out of the way of thinking the public engages), they admit socialization of values, conformity pressures, and familiarity may still be at work. Just the same, experts seem to pay more

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attention to probability especially in terms of dosage and exposure than the public who is concerned about consequences and implications. As such, public risk judgments are less closely related to fatalities than those made by experts. Hyperbolically, Renn (2004) went as far as claiming probability plays hardly any role at all (2004). To make matters more problematic, sometimes hazard experts disagree among themselves as well. Kahan et al. (2006) discovered that the grounds for disagreement are difficult to discern. “Disagreements among risk experts are distributed in patterns that cannot plausibly be linked either to access to information or capacity to understand it” (1093). Slovic claims cultural worldviews, such as political ideology and institutional affiliation, may account for bias in expert judgment (Slovic 1995, 662). As such, an argument has been made that experts screen arguments to protect their existing beliefs whatever the basis may be. Additional sources for disagreement between experts include the open-ended nature of scientific claims. Science is seldom definitive. In addition, knowledge building in science often involves legalistic and technocratic debates over findings and this may be disadvantageous to public groups by increasing confusion, engendering panic, etc. Altogether, this is interpreted by the public as disagreement which increases uncertainty (Kajanne & Pirttilä-Backman 1999) and uncertainty impacts trust which in turn impacts risk communication. No one seems to deny that experts rationalize hazards against dosage and exposure. The public does not. For example, “[t]he public would have more of an all or none view of toxicity… [T]hey appear to equate even small exposures to toxic or carcinogenic chemical with almost certain harm” (Kraus et al. 1992, 217 and 228) despite well-documented hormesis effects to some chemicals. MacGregor et al. (1999) reported “…people reserve the term exposure for substantial contact or contact sufficient to cause cancer” (653). Consequently a fundamental variable in traditional risk assessment does not seem to find footing in public risk perception algorithms. A set of interesting observations were made by Weinstein (1988) when studying public sensitivity to chemicals in food. The statement: When some chemical is discovered in food, I don’t want to hear statistics; I just want to know if it’s dangerous or not elicited strong agreement from 62% and moderate agreement from 21.6% of the respondents. “[E]ven a minute amount of a toxic substance in one’s food will be seen as imparting toxicity to the food; any amount of carcinogenic substance will impart carcinogenicity, etc.” (Kraus et al. 1992, 229). Evidence like this lead MacGregor et al. to conclude “…somewhat subtle changes in how the concept of exposure is conceptualized and communicated evokes very different inferences about its meaning” (1999, 652) and offers the risk communicator opportunities to ponder. As well put elsewhere, when a young child drops a lollipop on the floor, the brief contact with dirt causes the parent to throw it away rather than washing it off and returning it to the child. There is much disagreement on if, why, and how experts and the public use different tools to perceive risk as well. For example, “the assertion that experts’ risk perception is driven by objective data and risk assessments and somehow more simple than that of the public is based on a small sample of experts studies by Slovic and colleagues (See Slovic et al. 1979) at the end of the 1970s.”

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Sjöberg cautioned “…the frequent assertion of simplistic structure in experts’ risk perception is an urban myth” (1999a, 8). More research seems to be in order. To add another level of complexity, “…merely mentioning the possible adverse consequences (no matter how rare) of some product or activity could enhance their perceived likelihood and make them appear more frightening” (Slovic 1986, 405) such as what occurred with high voltage lines and cellular telephones. Consequently, “many risk communications about chemical exposure may lead more often to confusion or heightened concerns, when it is actually intended to reduce concerns” (MacGregor et al. 654). This becomes increasingly problematic as experts respond with more and improved risk assessment studies. Slovic (1986) warned merely mentioning possible adverse consequences could make them appear more frightening and even warned “…risk-assessment studies tend to increase perceived risk” (1993, 680) suggesting great care in how these are reported. Unfortunately, this phenomenon has been mostly ignored by those studying public opinions and attitudes and in designing risk messages for the public. As a result, our policy makers are not better equipped to determine public perception of risk at this time. For example, “…when politicians were asked to estimated what they believe was the public’s risk perception, they made gross errors” (Sjöberg 1999a, 5). Another wrinkle comes from public interest groups. They tend to overstate their capacity to represent the public interest and have convinced themselves that their concern over a “public” good makes them public agents. In terms of influence over policy makers, public interest groups, sometimes as a non-governmental organization, tend to have inflated the input. While they are active and concerned citizens, they may not be the public. Milbrath (1981, 480) explained that those who were active and take part in the process, who are able and willing to give of their time and energy, are quite unrepresentative of the public at large. Unless great care is taken in risk perception research, it can be counterproductive when these groups make a public view more salient, increasing their influence, when the view proposed is an unrepresentative generalization. There is the additional problem associated with framing (Scheufele & Lewenstein, 2006). Framing refers to the way information is presented rather than the content itself. It can have an important impact on how audiences perceive the information. Modes of presentation can differ in terms of terminological choices, visual cues, or other factors (Scheufele, 1999). The “Frankenfood” label used during the GMO debate is a good example of a frame that may directly impact risk perceptions among a public that does not follow scientific rules of decision making. Outside of nuclear energy, few studies have been undertaken dealing with risk perception of a phenomenon like nanotechnology. Moreover, earlier risk studies suffered from a radiophobic bias (fear of things nuclear including bombs). Some recent studies in biotechnology and use of chemicals associated with food offer some guidance. For example, in 2004, Savadori et al. studied expert against public perceptions on biotechnology in Italy. In general, they found the experts significantly and systematically perceived less risk than the public. In addition, they noted higher perceived risks when the biotechnology involved food-related rather than medicine related applications. Most interesting was their conclusion that expert and

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non-expert differences may be affected by the nature of the hazard. They added “…public perception of risk…could be reduced by providing information about benefits….” Unfortunately, they also observed some perceptions, including those of experts, “…could be increased by providing information on harmful effects and negative consequences” (1298) suggesting a complex dynamic is at work. In 2006 and 2007, three risk perception studies were reported. The first by Currall et al. (2006) examined public acceptance in terms of consumer behavior. The data which was collected in 2004 compared nanotechnology with other technologies. The authors remarked: “…[W]hen assessing the risks and benefits of nanotechnology, people may draw upon analogies” like feelings toward other technologies and other health and safety issues. They reported that nanotechnology was seen as relatively neutral. For example, nanotechnology was perceived as “… more risky and less beneficial than solar power, vaccinations, hydroelectric power and computer display screens” (154). Their commentary added: “…[N]ow is the time to educate the public aggressively with facts about the risks and benefits of nanotechnology. Education can prevent opinions from becoming polarized on the basis of misinformation” (154). While they are partially correct in terms of reducing polarization based on misinformation, Kahan et al. (2007) seriously challenge the utility of broad-based educational messages. Another was reported by Siegrist et al. (2007) examining specific applications and risk perception. They verified the public perceives “more risks associated with nanotechnology than experts” and worried that “…experts might not be inclined to initiate the risks assessments that are expected by the public.” The team opined ominously. “The importance of trust for the positive perception of new technologies suggests that a preventable event with significant negative consequences must be avoided. Such an event, indicating lack of concern for public welfare, could have a disastrous impact on trust and result in decreased acceptance of nanotechnology” (87). This conclusive remark while intuitive still needs some empirical validation. The final one by Kahan et al. (2007) released the first data set specific to nanotechnology risk perceptions and sets very high standards for studies to follow. The study concludes if the process of biased assimilation and polarization unfolds unchecked when it comes to processing information on nanotechnology, the future of nanotechnology may be “marked by the sort of conflict and division that historically attended nuclear power and today characterized the global warming debate.” This tendency by the public to filter information through emotion and values might be mitigated by framing exercises though framing as Kahan et al. suggest but that may be just one option. The most interesting finding from this team was the effect of information on affect toward nanotechnology. “Exposure to information produced no overall shift in risk/benefit perceptions” and “…this finding weighs strongly against the inference that people can be expected to form a more positive view of nanotechnology as they learn more information.” This seems to produce quite a challenged to the deficit theory experts who claim more education is the answer and to the public outreach practitioners who are experimenting with deliberative polling exercises and cafes. As such, it might be profitable for us to unbundle and re-examine the entire conceptualization of risk as it applies to emerging technologies. Slovic et al. (1985, 92–93)

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supposed: “Attempts to characterize or compare risk, set safety standards, and make risk decisions will founder in conflict if policy makers insist, as they often have, on the narrow definition of risk as a conditional probability of dying”. We need to understand better the processes involved rather than to institute experiments which may not be grounded in relevant research findings. We need to develop more refined techniques for representing uncertainty and data sets associated with traditional risk assessment models. “..[R]isk assessment [may have] been oversold because of the need to rationalize decisions about chemicals” (Neil et al. 1994, 201). Finally, the window of opportunity remaining for risk communicators to engage the public is closing quickly as nanotechnology products are marched out onto the market. We know “…risk and benefit judgments of the hazards were found to be more strongly negatively correlated under time pressure” (Finucane 2001) and as such, it may behoove us to provide opportunities and methodologies to facilitate public engagement, sensibly and soon.

5.6

On Sources and Trust

The public cannot be told they are safe. This top-down mode of communication is not sufficiently effective, especially when the source of the message may not be sufficiently trustworthy and the subject is exotic, such as invisible nanoparticles as a constituent of other products. Slovic (1993) attributed the divisiveness of controversies surrounding risk management and the failure of risk communication to date to a lack of trust and reported that distrust was “strongly linked to risk perception and to political activism to reduce risk” (676). As such, trust can be especially important when designing a communication strategy. Savadori et al reported: “[t]rust helps us reduce uncertainty to an acceptable level and to simplify decisions” (1290). Unfortunately, trust is fragile. “It is created slowly, but can be destroyed instantly. In addition, when it comes to winning trust, the playing field is not level: it is tilted toward distrust” (Savadori et al. 1291). While others are less unconditional than Savadori, they still advise caution. For example, Sjöberg (2001) claimed “…general trust add very little to the explanatory power of trust” (193) suggesting that “specific trust is a more powerful construct than general trust for explaining risk perception (195),” one tailored to the case instant. This suggests an important contextual foundation may be necessary in trust research to reduce overly generalized and suspect findings. Without exception, we know the public has less trust in experts associated with industry than those associated with academia. Unsurprisingly, Barke and JenkinsSmith discovered that experts’ risk perception seemed to be correlated with employers’ interests (1993). Indeed, industrial toxicologists tend to report risks lower than their colleagues in academia. The public conjectures that experts may know less than they claim and they may be corrupted due to their being hired by the industry or government. In addition, it may be perceived that those who are primarily involved in an activity associated with a risk, like science, may rate it

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lower (Sjöberg 2002). Associatively, Sjöberg reported “experts probably trust industry, agencies and other experts more than the public does” (1999b, 5). The public also notices experts do disagree and this generates uncertainty. While the public tends to use trust to compensate for their lack of technical understanding of risk issues (Jenkins-Smith & Silva 1998), this becomes problematic with expert generated uncertainty. In addition, there remains some disagreement whether trust is a single variable. It may be a variable bundle composed of many different variables working together to establish trust. Furthermore, there are some inconsistencies in the findings about trust. For example, Sjöberg (2001) found the relationship between trust and risk perception was weak to moderate while admitting it “is more important for individual consumer behavior” (190). Put simply, little about trust may be selfevident. Also, trust varies from culture to culture. For example, trust in government entities seems to have weakened in Europe following the mishandling of information about BSE (bovine spongiform encephalopathy) tainted meat in the UK and dioxin contamination of dairy and poultry products in Belgium and the Netherlands (Savadori et al. 2004). For years, it was assumed the public’s trust in American government regulators was substantially higher. Very recent research on public trust and regulation of technology completed by Hart Research Associates (2006) on an American sample found trust has been eroding and European and American samples are not as divergent as previously reported. In some instances, the Hart research noted specificity of trust as in the examples of cosmetics and sunscreens using nanoparticles. Kahan et al. believed “…the people [the public] trust, not surprisingly, the ones who share their cultural worldviews…” (1085). As such we may need to tailor the communication strategies involving trust values to specific cultural fields. To be sure, specific and especially general trust building exercises should be a component of risk communication. “[T]he generation of cultureindependent forms of trust particularly between lay person and risk experts, may be the most valuable feature of genuinely democratic policymaking…. And one of the most important conditions of such trust, research shows, is the perception that officials have consulted and are responsible to affected members of the public” (Kahan et al. 2006, 1104). While public outreach and stakeholder participation have become standards features of government and public interaction over nanotechnology, especially as a component of the US National Nanotechnology Initiative and the EU’s 7th Framework, it is too early to assess how effective these exercises have been in building trust. Regardless, it is important to keep in mind: openness and involvement, “…however, is no guarantee of success” (Slovic 1993, 680). This leads us to an important adage: “[r]isk assessment, though invaluable to regulators in the design of management strategies, is not at all convincing to the public” (Kraus et al. 1992, 230). We have learned as well that “…communicating the results of risk assessment to the public relies heavily on language rather than numbers” (MacGregor et al. 658), hence we need to examine risk perception qualitatively as well as unbundling trust examining it against a case instant, such as a nanotechnology related product or product line.

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On Sources of Information

One thing we do know. The public is under-informed when it comes to applied nanoscience and nanotechnology and it behooves us to better understand how they are learning about “nano.” The social amplification of risk framework describes how both social and individual factors act to amplify or dampen perceptions of risk and through this creates secondary effects such as stigmatization of technologies, economic losses or regulatory impacts. While many variables can amplify and attenuate risk messages, most of the focus has been on media (Pidgeon et al. 2003, Kasperson et al. 1988). We would hope the mass media would play a watchdog role (Siebert 1956) overemphasizing certain risks or aspects of an issue in order to raise public awareness before potential negative impacts can occur. Unfortunately, many researchers, including Jasanoff (1993), comment “…the public has a distorted view of risk because the media portray science in an inaccurate way, with exaggerated accounts of uncertainty and conflict” (123). The media reports “gripping instances of misfortune, whether or not representative of the activities that give rise to them” (Sunstein, 125) “often without enough facts to alleviate the possible fears they cause” (Wahlberg & Sjöberg 2000, 34). The complex motivation for accentuation is mostly propelled by economic self-interest and the drive for increased readership and viewership especially given recent competition from new media resources. To worsen matters, “…members of the public appear to be more willing to believe risk increasing signals than risk-decreasing signals, regardless of who provides the signal.” Moreover, as Jenkins-Smith and Silva reported, “…those who make claims that risks are large will be likely to have greater impact on public acceptance than those who make claims that risks are small” (118 and 199). They recommended the development and maintenance of the general credibility of the scientific process and the scientific integrity of organizations and scientists undertaking risk assessments, a meritorious effort but not necessarily sufficient given the expert uncertainty discussion above. The media (including movie and television drama) has been the primary scapegoat when it comes to risk policy dilemmas and bad news destroys trust. The media may even be able to generate risk contagion and cascades. Sunstein briefly discussed availability cascades when he describes events becoming available to large numbers of people from media coverage and group membership This can lead to moral panics whereby large numbers perceive sources of danger far out of proportion such as “dissidents, foreigners, immigrants, homosexuals, teenage gangs” (98), etc. The public gets information from somewhere and the media seems to predominate over other sources. As well, sources of information have varying degrees of credibility. Credibility is important to both trust and risk perception. It has repeatedly been discovered high credibility of information source, like trust in risk management, is inversely correlated to risk perception (Finucane et al. 2000). Savadori et al. (2004) indicated that newspapers and TV are among the most trusted sources of

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information (in Italy) about food-related hazards, followed by medical sources, the government, friends, industry, magazines and radio, university scientists and consumer organizations. An odd conundrum, Savadori et al. also found newspapers and TV were frequently cited as mistrusted sources (see also Frewer et al.1996). We know the traditional media serves to attenuate and amplify messages associated with risk and the data sets for these conclusions were drawn from studies of newspapers and television news broadcasts. By and large, this research also preceded the proliferation of satellite and cable television outlets and even more importantly the World Wide Web. Denying the importance of these non-traditional sources of news information about data used in public risk perception is not useful. Sources of information, in terms of amounts of information, have begun to shift. An Economist cover in 2007 lamented the death of the newspaper. Multiple articles have bemoaned how television news has emphasized hyperbole and entertainment and decreased its information content significantly. While baby boomers still get some of their news from traditional sources, many do not and generations X and Y and onward simply do not. A recent study found half of consumers turn to network television for breaking urgent news, 42% rely on radio, about a third look to local newspapers or cable news outlets, and a quarter use the Internet sites of print and broadcast media… Asked which sources of news they expect to rely on in the future, 52% said they will “primarily” or “mostly” trust traditional news sources over emerging sources, and 35% said they expect to confer “equal trust” on both types of news outlets. Thirteen percent said they expect to put more trust in emerging sources (Burns 2006), so the swing seems underway. These emerging sources are called new media. They seem to be here to stay and while the power of the voices of bloggers may be exaggerated at times, the combined voices of Wikipedia, blogs (written and video), podcasts (audio and video), and IPTV (YouTube) are affecting how news information is communicated to the public. Most importantly, as news media becomes more self-selectively personalized, readers will be even more able to ignore information that contrasts with pre-existing judgments. Sunstein worried about this self-sustaining cycle of one-sided information. Describing social cascades, Sunstein attested the smallest of triggers can produce large effects and worries about a major event in history being triggered by unbalance or even misinformation (2001). The extensiveness of new media is striking. A Pew Internet and American Life project estimated 11% (or 50 million) of Internet users are blog readers. 1 million blogs are updated daily. Calacanis of Weblogs predicted by 2009, 50% of the country will be blogging. The size of the blogosphere doubles every five months. Perseus Development Corporation reported 90% of blogs are authored by people between the ages of 13 and 29, with 51% between the ages of 13 and 19. While today only 3% of Internet users read them daily, among the young (18–29) that percentage rises to 44% (McGann 2004). In terms of Wikipedia and after only 2 years, Wales and Sanger’s Wiki-model had over 100,000 English articles. After 3 years, it exceeded 200,000 in English with 500,000 in 50 languages. In February 2004, articles were added at 2,000 a day. Today, there are 100 active language versions of Wikipedia and in August 2005, 12,750 readers visited Wales and Sanger site

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daily. In terms of accuracy, a recent Nature reported comparable accuracy of Wikipedia to The Encyclopedia Britannica for articles on scientific subjects (Giles 2005). While the podcast base is currently 4.5 million, it will grow to 60 million by 2011. About 22% of iPod users are aware of and consuming podcasts. eMarketer estimated there will be 3 million active podcast listeners by the end of this year and 7.5 million by 2008. Diffusion Group predicted 11 million by 2008. NPR reported to have had 18 million of their podcasts downloaded since August 2006 (Forrester Report 2006). IPTV (Internet protocol TV) supported sliver TV is coming. YouTube, the best known sliver TV, has daunting statistics. In July 2006, YouTube viewers were “watching more than 100 million videos per day on its site” (Bogatin 2006) and the fare is not solely amateur rock videos, the site is loaded with videoblogs and news commentaries. Today (October 11, 2006), nanotechnology gets 60 hits while science receives over 11,000. So much so, its creators sold YouTube to Google in mid-October 2006 for over $1 billion. The day Google bought YouTube Google’s stock value increased by $4 billion. Cable modems work as miniature TV broadcast and reception stations, receiving data from one sliver of a shared TV channel and transmitting it on another. Anyone with a digital video camera and a broadband connection can broadcast. Individuals will capitalize on this and broadcast their own specialty news forums with broadband connections. Think of thousands of internet channels of specialized news. In the US alone, we have over 100 million broadband users and millions of potential producers today. While traditional media, such as newspapers and TV stations, have added web-based adjuncts, those tend to emphasize standard format and are used to highlight published or broadcasted features and some current events. Digital versions of newspapers and mpg4 and H.263 rebroadcasts of news shows seem to be the current model.

5.8

Challenges and Conclusions

We have at least six research questions to validate if we are to design an effective risk communication strategy for applied nanoscience or nanotechnology. 1. Do experts and non-experts significantly disagree in estimates of risk to health and safety associated with applied nanoscience? 2. What variables do non-experts use in perceiving risk to health and safety associated with applied nanoscience? 3. What role does trust in a source, both general and specific, play in non-expert perceptions of risk to health and safety associated with applied nanoscience? 4. What sources for information do the non-public use in estimating risk to health and safety associated with applied nanoscience? 5. What effect do the sources of information have on the perception of risk to health and safety associated with applied nanoscience? 6. What effect has the “new media” had and will its have on non-expert perceptions of risk to health and safety associated with applied nanoscience?

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We need to research public perception, trust, and sources as they apply to nanotechnology. While we may generate some opinion research on nanotechnology, our goals are more foundational. We may end up validating some previous research and debunking the conclusions of others. We believe the specific focus of the grant on nanotechnology will be valuable to stakeholders and public engagement. We need an engagement in social science research which should run parallel to the toxicology research on nanoparticles. This small investment is an important partner to the environmental health and safety research currently being undertaken. As data on toxicology surfaces, it would be fortuitous if we had a strategy on engaging the public which is based on something other than supposition and educated guesses. In the US, some initial work in this area is currently being done at a very general level as part of the two Centers for Nanotechnology in Society at Arizona State University and at the University of California, Santa Barbara. In particular, one of the CNS-ASU research teams is examining impacts of media coverage on public perceptions of risks and benefits of nanotechnology. This research, however, is concerned with the broader societal processes surrounding media and the public, and less with the more immediate concerns about toxicity, regulation, and public input.

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Savadori, L et al. 2004. Expert and public perception of risk from biotechnology. Risk Analysis 24.5: 1289–1299. Scheufele, D. A. 1999. Framing as a theory of media effects. Journal of Communication 49.1: 103 122. Scheufele, D. and B. Lewenstein. 2006. The public and nanotechnology: How citizens make sense of emerging technologies. Journal of Nanoparticle Research 7.6: 659–667. Siebert, F. S. 1956. The Libertarian Theory. In Four theories of the press, Frederick S. Siebert, Theodore Peterson, and Wilbur Schramm, eds. 39–71. Urbana, IL: University of Illinois Press. Siegrist, M et al. 2007. Risks and nanotechnology: The public is more concerned than the experts. Nature Nanotechnology 2: 87. doi:10.1038/nnano.2007.10. Sjöberg, L. 1998. World views, political attitudes and risk perception. Risk: Health, Safety & Environment 9: 137–152. Sjöberg, L. 1999a. Political decisions and public risk perception. A paper read at the Third International Public Policy and Social Science Conference, St. Catherine’s College, Oxford University, UK, July 28–30, 1999. Sjöberg, L. 1999b. Risk perception by the public and by experts: A dilemma in risk management. Human Ecology Review 6: 1–9. Sjöberg, L. 2001. Limits of knowledge and the limited importance of trust. Risk Analysis 21: 189–198. Sjöberg, L. 2002. The allegedly simple structure of experts’ risk perception: An urban legend in risk research. Science, Technology, & Human Values 27.4: 443–459. Slovic, P. 1986. Informing and educating the public about risk. Risk Analysis 6: 403–415. Slovic, P. 1987. Perception of risk. Science 236: 280–285. Slovic, P. 1993. Perceived risk, trust, and democracy. Risk Analysis 13: 675–682. Slovic, P. 1999. Trust, emotion, sex, politics, and science: Surveying the risk-assessment battlefield. Risk Analysis 19: 689–701. Slovic, P et al. 1979. Rating the risks. Environment 21: 14–20, 36–39. Slovic, P et al. 1985. Characterizing perceived risk. In Perilous Progress: Managing the Hazards of Technology, Robert Kates, Christoph Hohenemser and Jeanne Kasperson, eds., 91–125. Boulder, CO: Westview Press. Slovic, P et al. 1995. Intuitive toxicology II: Expert and lay judgments of chemical risks in Canada. Risk Analysis 15: 661–675. Sparks, P. and R. Shepherd. 1994. Public perception of the potential hazards associated with food production and food consumption: An empirical study. Risk Analysis 14: 799–806. Starr, C. 1969. Social perception versus rational risk. Science 165: 232. Sunstein, C. R. 2001. The daily we. The Boston Review. http://www.boston.review.net/BR26.3/ sunstein.html. Cited 15 June 2006. Sunstein, C. R. 2002. Risk and Reason: Safety, Law, and the Environment. New York: Cambridge University Press. Wahlberg, A. AF. and L. Sjöberg. 2000. Risk perception and the media. Journal of Risk Research 3: 31–50. Wyler, A. R et al. 1968. Seriousness of illness rating scale. Journal of Psychosomatic Research 11: 363–374.

Chapter 6

Environmental Holism and Nanotechnology1 Thomas M. Powers

6.1

Introduction

The entering wedge of the ethics of nanotechnology—as with any emerging technology—might be a deceptively easy question: What should we protect? From there the matter becomes difficult. Science must tell us what the technology threatens, and how to measure the extent to which the threat is realized. Most difficult, though, is deciding what is worth protecting, and why. The answer to this latter question requires a theory of value, and most ethicists start with an anthropocentric one.2 According to most ethicists, we should protect some combination of human rights, preferences, health, future generations, and so on, because these things are morally valuable. Current research into environment, health, and safety (EHS) issues in nanotechnology is mostly anthropocentric,3 and might be better construed as research into threats to human health and safety, and to the environment insofar as it affects humans. I want to investigate the answer to the “deceptively easy” question from a different, non-anthropocentric starting point: environmental holism. In this essay I will explain a version of environmental holism and sketch what should be protected from any harms that might be caused by nanotechnology applications on this view. I will not argue that this kind of non-anthropocentric view is superior to all anthropocentric ethics, for surely this conclusion is beyond the scope of an essay. I will argue, however, that various human interests are protected 1

Support for this work was provided by the National Science Foundation’s Delaware EPSCoR grant EPS-0447610, through the Delaware Biotechnology Institute. 2 Though anthropocentrism in ethics has dominated the Western tradition, through the influence of views otherwise as diverse as those of Aristotle, Kant, and Mill, there are some notable exceptions. For instance, see Bentham, 2005;; Singer, 1990. 3 The most concentrated EHS research on nanotechnology has been published in an ongoing forum series in the journal Toxicological Sciences. The authors of the first contribution in that series indicate their general anthropocentric outlook: “A continuing evaluation of the human health implications of exposure to nanoscale materials will be essential before the commercial benefits of these materials can be fully realized.” See Thomas and Sayre, 2005

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(though incidentally) by a preferred interpretation of environmental holism, one inspired by the writings of Aldo Leopold. In terms of popular appeal, environmental holism attracts some of the most fervent environmentalists, or at least those who are inclined to articulate their convictions in the form of an ethical theory. General or abstract holism is the view that “the whole” is greater than the sum of its parts, or can only be understood as a whole, and not merely as a collection of its parts. In that sense, holism is opposed to reductionism and philosophical atomism. As a species of the general view, environmental holism is often suspected of having more in common with non-philosophical commitments, such as holistic medicine or “back-to-nature” lifestyles, than with philosophical theories such as semantic holism (that the meaning of terms can only be fixed in the context of larger discourse structures) or epistemological holism (that any statement in a theory, or indeed any theory, can only be confirmed relative to a larger body of beliefs). I will construe environmental holism as a philosophical theory—not one about the locus of meaning or confirmation, but of ethical value. Its main contention is that the one thing worth protecting, ultimately, is the environment as a whole. The environment is to be construed here broadly, as a system of systems that provides the basis for all life on earth. While its parts (soils, waters, individual animals and plants, species, ecosystems, etc.) are also valuable and ought to be protected, according to this view, our obligations to these parts—indeed, even to other human beings—are defeasible. I will have more to say about this feature of obligations at the end of this essay. For now, let us say that environmental holism allows obligations to the parts of the environment to be defeated for the sake of the whole. The overarching obligation, grounded by the intrinsic value of the whole, cannot be analyzed as obligations to the parts. This view is in some respects more stringent than an environmental ethics that merely advocates animal rights, protection of endangered species and wilderness areas, and so on. While there are many deep philosophical issues to be worked out in environmental holism, there is a more immediate, practical import to considering the view when thinking about the ethics of nanotechnology. If holism is correct, then scientists will have to look beyond human health and safety for nanotechnology threats and will have to devise broader and more sensitive measurements to determine whether nanotechnology is causing relevant harm. Currently, the focus in metrology is on human health-related exposure to nanoparticles. Certainly that metric would have to be broadened under holism.

6.2

Version of Environmental Holism

In order to flesh out a version of an ethic worth adopting, let us begin with a basic division within environmental holistic ethics. We may define one sort of view that is non-consequentialist or deontological. It holds that there are certain ethical rules or principles that must be obeyed concerning what we humans do to the natural

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environment. For instance, consider the view that nuclear fission is, in itself, a violation of a naturalistic principle and therefore a “crime against nature,” irrespective of the consequences for warfare, the production of radioactive waste, and the like.4 The naturalistic principle in this case would hold that atoms are “made by nature” and thus should not be destroyed (or split) by humans. An analogous view concerning nanotechnology might hold to the sanctity of naturally occurring molecules. On this view, there must be many other created or engineered entities that also violate naturalistic principles. Artificial diamonds or even the synthesized transuranium elements5 would be examples. Similar views abound concerning the “unnaturalness” of homosexuality, miscegenation, cloning, and other practices. But because this view cannot give further arguments—grounded in adverse consequences—for the wrongness of such unnatural practices and entities, it is a hard to see what philosophical appeal it has. Similarly, there seem to be no good a priori grounds for objecting to the practice of engineering at the nanoscale. While nonconsequentialist or “naturalistic” holism may have religious or spiritual appeal to some people, it is not clear that it is engaged with science. This is peculiar for a view that appears to rely on a shared sense of the “natural order of things.” Moving beyond this non-consequentialist position, we might ask a more general question of engineering ethics—whether the size of an engineered object per se can ever play a role in its moral acceptability. Consider the current debate over the size of automobiles. Why do some people believe that extra-large vehicles are morally problematic? Some reasons are that they typically consume more fuel, produce more pollutants, and are more injurious to third parties in collusions, when compared to an average sized car. But this is also true of multi-passenger buses in public transportation systems, and no one thinks that buses are morally objectionable. The problem, then, with extra-large private non-commercial vehicles must be that they cause these harms unnecessarily, and with very few offsetting benefits to society. The same considerations will apply to nanotechnologies. Based on their consequences, both good and bad, are nanoscale engineered molecules worth it? Do they compensate for the harms they may cause? When we construct a version of environmental holism that does make appeal to consequences, the objections to new and very small engineered molecules does gather some force. On a consequentialist holism, it is not the change in size alone which engineered nanoparticles present that is problematic. With the change in size there come changes in physical/chemical properties, including electrical conductivity, magnetism, optical activity, tensile strength, reactivity, and catalysis (Thomas and Sayre, 2005, 316; Lin et al., 2006). These new properties could affect the interests of individual animals (including humans), species, and the health of ecosystems and other parts of the whole. But it is not with the parts that

4

For an illustration, see Boyer, 1994. All of the elements in the periodic table above uranium, with atomic number 92 (with the exception of plutonium and neptunium) arise only by human synthesis. They are all unstable and radioactive. 5

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environmental holism is primarily concerned. These interdependent parts stand in a range of relationships, from symbiotic to competitive. Their existence as system depends on natural processes that are not very well understood. Because the environment relies on processes such as photosynthesis and respiration, it is the effect on these processes that makes the changes in physical/chemical properties ethically relevant. These processes will have to be compatible with engineered nanoparticles, in the likely event that they are released into the environment. Consider this brief argument for the importance of photosynthesis. The earth alone is a closed-energy system; without the sun supplying energy, there never could have been complex forms of life on earth, and life as we know it could not be sustained if the sun could no longer supply the energy, or the plants and phytoplankton could not convert it. Earth systems, in this sense, “feed off” of the energy provided by the sun, and convert that energy into chemical energy (glucose) through photosynthesis. The sun makes the earth an open-energy system, if only temporarily. Therefore, there is no process on earth of greater importance than the conversion of energy by photosynthesis. Wars, plagues, and famine may be regrettable, but nothing would be worse than losing photosynthesis. Whatever processes we might want to protect from emerging technologies, none could be more important than photosynthesis. We will consider these earth-system processes in greater detail later; for now, let us turn to the philosophical basis for worrying about them at all.

6.3

The “Land Ethic”

Aldo Leopold’s (1987) account of a “Land Ethic” in his Sand County Almanac counts as one of the few serious attempts to ground consequentialist environmental holism in a value theory. His account generates a notion of right action, and corresponding moral obligations to an entity he calls the “land.” Land is a hierarchical pyramid of interdependent constituents. The base layer is the soil, and subsequent higher layers are defined by “who eats what.” Insects, plants, small herbivores, omnivores, and large carnivores all depend on the soil, but also depend on members of other layers to keep populations of predators and prey in check and transmit nutrients back to the soil. Leopold conceives of the obligations as having the general goal of protecting the health of the land, which he understands to be the ability of the various layers of the land pyramid to transmit photosynthetic energy upwards, and to return nutrients downward to the soil layer. Because his view is holistic, Leopold does not insist on the protection of individuals or species. (He was hunter, professional forester, and a professor of game management.) Rather, his ethic warns against diminishing the health-maintaining functions of the various layers in the pyramid. In particular, Leopold cautions that “deferred reactions” from environmental harm are often hidden to the human agents who may eliminate a prey or predator species, practice soil-depleting agriculture, and the like.

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For Leopold, all forms of ethics involve competition and cooperation of interdependent members of communities. Predation is something that Leopold celebrated, in principle, and he had no qualms about recognizing Homo sapiens as the dominant species to date. What is lacking in anthropocentric ethics for him is both a deeper scientific appreciation of the varieties of relationships involving human and non-human parts of the land. This scientific appreciation produces a respect for the values of belonging to a community. Unless we accept the communal land ethic, Leopold believes, humans will remain fixated on conquering the land and dominating ecosystems. In accepting an ethical obligation to land, we expand the boundary of traditional human communities to include soils, waters, plants, and other animals. The recognition of our community membership, according to Leopold (1987, 202), will lead us away from the view of land as mere property, and towards an ethical stance to it. The philosophical origin of this ethic “is the tendency of interdependent individuals or groups to evolve modes of cooperation,” or what he calls symbioses. These symbioses range over biological and ecological relationships to politics and economics, which Leopold calls “advanced symbioses.” Leopold’s reliance on the notion of the symbiotic relationship, found in nature but also replicated in complex forms in human societies, forces his readers to question whether his account is descriptive or normative. Let us consider the example of markets, which are certainly a central feature of the advanced symbiosis of economics. From the point of the view of the seller, each market transaction is egoistic activity, and conversely the same transaction is egoistic for the buyer. But because (under certain ideal assumptions) the utility of each increases, and does so because of the activity of the other, the market transaction is also other-regarding activity. Each knows that the rules against fraud and theft are in place for a reason; without them, neither party would be able to benefit repeatedly from the cooperation. This outcome matches the lesson of the iterated Prisoner’s Dilemma solution. To an outside observer, the cooperative outcome in market transactions may look like the discharging of mutual obligations of buyer and seller. From this perspective, the symbiotic relationship has normative content. To another observer, trained to think only about natural selection and competitive advantage, the same activity is just instinctive egoism. For Leopold, examples of symbiotic relationships in nature and in human societies will always have that same fact/value ambivalence. The desired outcome of this Leopold’s land ethic (Leopold, 1987, 203) is the development in human populations of a consciousness of obligations (and not just privileges) towards the land. Leopold (1987, 205) regards this consciousness, given population density and technology, as an “ecological necessity.” Here too ambivalence arises in the interpretation of what is ecologically obligatory. Conservation is required of humans, for the sake of other parts of the land community and, at the same time, for our own sake. Leopold recognizes that humans have developed a conscience with respect to some of our obligations—the ones we owe to individual humans, and to our social groups. But the ecological conscience—the awareness of obligations and constraints towards the land—had not been developed widely in anthropocentric ethics nor in human practice in Leopold’s day.

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According to Leopold, such an ethical stance towards land has been made difficult in modern times, due to an increase in the efficiency of tools. Our modern human predicament is generated by the complexity and scope of our effects on the land, and by the land’s “deferred reactions” to their causes. Since the scientist knows at least that “the biotic mechanism is so complex that its workings may never be fully understood,” the ethics that follows from the science must advocate extreme sensitivity to the causes of the deferred reactions. The reactions themselves might not obtain for generations; as an example, consider the problem of climate change and carbon dioxide.6 The kinds of changes that Leopold considers most serious are the elimination of large predators, the introduction of large populations of domesticated species, the infertility of the soil through agriculture, erosion and pollution of soils, and the obstruction of waters. All of these have been made possible by humans’ use of “efficient” tools. Leopold explains the conceptual role of evolution in the land ethic in his descriptions of species roles, natural selection, and the structure and complexity of food chains. Evolution contributes to the diversity of species, and cooperation/ competition at the level of species account for their interdependence. Through natural selection and mutation we get greater species differentiation and thus the development of a high, variegated land pyramid from a low, squat one. Consider the development of early single-cell organisms into multicellular organisms and eventually animals, land plants, insects, and so on. Food chains, which conduct photosynthetic energy upward, have become ever longer (over geologic time) as more layers are added to the pyramid. The upward circuit of the food chain is completed when energy returns to the soil through death and decomposition. In developed ecosystems, especially in wilderness, the food chains have become greatly “tangled.” Their entanglement comes from the fact that even competition among individuals is, from the point of view of evolution, a symbiotic relationship between species. We can see this in one of Leopold’s favorite examples: large carnivores and deer. The elimination of the predator species, in the end, does harm to the prey species by leading to population excess, less robust individuals, and destruction of habitat. In a healthy ecosystem, the food chains cycle energy through many levels, and sustain diverse populations of plants and animals at all levels. These energy circuits are subject to evolutionary change, but in those cases the change is slow and local. In other words, in typical cases, species that are better adapted win out. Humaninduced changes, on the other hand, are of “unprecedented violence, rapidity, and scope” (Leopold, 1987, 217). Given the timescale and complexity of evolutionary change, is it right for humans to introduce such violence?

6

According to Lord May, former president of the British Royal Society, “[o]nce in the atmosphere, the characteristic ‘residence’ time of a carbon dioxide molecule is a century. And the time taken for the oceans’ expansion to come to equilibrium with a given level of greenhouse warming is several centuries.” (May2005).

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The modern notion of moral right, while not absent in Leopold’s theory, is used sparingly and in the context of his holism. Leopold writes of the land’s “right to continued existence” (Leopold, 1987, 204) and of the “biotic right” (Leopold, 1987, 204) of economically negligible species to continue. But in his theory the notion of right does not operate as it does in classical liberal theories. According to these theories, rights are trumps held by individuals; they hold regardless of the wishes or benefit of the groups to which the individual belongs (Dworkin, 1989). In Leopold’s theory a right must yield to considerations of the integrity and stability of the whole. In this sense, talk about the right of any species to continued existence is elliptical for the claim that the species plays an important role in a food chain—one that it has come to occupy through the long process of evolution. In other words, the whole would be made less robust if the part were gone, and such damage would probably constitute a wrong in this case. However, extinction of a species per se cannot be considered wrong on this view. Indeed, extinction is as important as species differentiation in evolution. The reason that rights cannot be trumps in Leopold’s theory is that he is a valuepluralist, and rights do not trump values but are rather subservient to them. The values in his theory are not always ethical values, for much of what he writes seems to concern aesthetics. He wants us to preserve some values, even in the face of an inevitable “world-wide hybridization of cultures through modern transport and industrialization” (Leopold, 1987, 188). The values that are worth preserving arise both from community, and from the wildness of Darwinian nature. In Darwin’s writings, Leopold claims to find a “sense of wonder over the magnitude and duration of the biotic enterprise” (Leopold, 1987, 109) He advocates saving the land from the impact of mechanization, so that humans can “reap from it the esthetic harvest it is capable, under science, of contributing to culture” (Leopold, 1987, vii). Even evolution, as described above, seems to take on a kind of aesthetic value in Leopold’s writings. Because of this plurality of values, no individuals (human or other) can have a moral claim that trumps all other values.

6.4

Holism and the Critical Zone

For the sake of argument, let us suppose that this view about environmental values, both aesthetic and ethical, is correct. What would be the concerns of such an environmental holist when faced with the next generation of nanotechnology? Before we attempt to answer this question, we must update Leopold’s pyramid with a basic understanding of contemporary research on the “critical zone”—the near-surface areas of the earth consisting of the hydrosphere (fresh and salt waters), biosphere (all life-sustaining earth environments), lithosphere (crust and mantle), and pedosphere (outer soil layer). These areas support plant, groundwater, marine, and geologic systems. It is in the earth’s critical zone that most of the resources that sustain life are either produced or made available to living organisms. One of the

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most important processes that take place in the critical zone, as discussed earlier, is photosynthesis. In this process, autotrophs (primarily trees and phytoplankton) change carbon dioxide into oxygen and glucose. Photosynthesis and respiration themselves are important parts of the carbon cycle, a constant exchanging of carbon between the atmosphere and biosphere. Another critical zone process is mineral weathering, one form of which involves plants breaking down minerals that then serve as plant nutrients (Kelly et al., 1998). These crucial processes, along with microbial interactions, soil formation, movements of nutrients, dispersal and breakdown of toxins, groundwater flow, and accumulation of sediment, make life on earth possible (National Research Council, 2001). While Leopold acknowledged the complex relationships between the parts of the land pyramid, he mostly wrote of predation and soil erosion. We now know that both the parts of the land community (soil, plants, animals, waters) and the processes in the critical zone determine the health of the land. For the advocate of nanotechnology, a commitment to environmental holism of this sort would require an ability to measure the disruptive effects of nanoparticles in the critical zone processes, and not just in large mammals that are epidemiologically similar to humans, or in plants that humans eat. Accumulation of nanoparticles in soils, transport to the cells of plants (which recent research suggests),7 and cellular buildup in prey species are all of concern. While the holistic approach cannot yet pass judgment on the ethics of nanotechnology, it can at least tell us where to look for the relevant facts. We can get a better idea of where nanotechnology EHS research ought to focus, according to environmental holism, by considering the new interdisciplinary field of hydropedology, which is also a critical zone science. This science combines soil physics, hydrology, and pedology to study processes crucial to agriculture, groundwater recharge, contaminant flow, and the like. It seeks to bridge “disciplines, scales, and data” to give a holistic understanding of soils and water (Lin, 2003). At the microscale, hydropedology studies the molecular composition of soils. At the mesoscale, the focus turns to how this composition affects the physics of soils, and hence the ability of roots to penetrate the soil and grasses to stem erosion. Macroscale studies explain water flow over landscapes, watershed properties, and predict optimal regional soil uses. Many questions about nanotechnology, from the point of view of the hydropedologist, would become pressing. Since a nanoparticle has such a large surface area per unit mass, it interacts differently with other naturally occurring molecules than would a mere microscale molecule made up of the same chemical

7

Personal communication with Prof. Yan Jin of the University of Delaware, on pre-publication findings concerning “Fate and transport of manufactured nanoparticles in porous media” In experiments for a U.S. Environmental Protection Agency grant, Prof. Jin’s lab found that a nanoscale form of iron oxide (Fe3O4) was taken up from a nutrient solution into the cells of a pumpkin plant. These preliminary results indicate the tendency of some nanoparticles to bioaccumulate in plants, and thus to enter the food chain.

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elements. For instance, nanoscale carbon tubes, while elementally carbon, do not behave like graphite, which is elementally the same substance. What effect will these nanoparticles have on the composition of soils, assuming that they will eventually end up there? Will nanoparticles interfere with groundwater recharge? Will nanoparticles inhibit root elongation in some plant species, and thereby lead to soil erosion? While we cannot answer all of these questions now, we ought to persist in asking them. There is already some evidence that alumina nanoparticles do inhibit root elongation, and hence might be deemed “phytotoxic.”8 While nanotechnology seems to be threatening to portions of the botanical world, this will not likely be the case with all plants. Engineered nanoparticles are not new chemicals, they are only novel molecules. So chemically their parts are already present in natural environments. We know that trace chemical elements are important for the growth and reproduction of plants, and that these same elements in higher concentrations can be lethal to plants. Many plants and bacteria, however, can bioreduce metal ions from soils, including metals that are at the molecular nanoscale. Bioreduction can take place either as decomposition of nanoparticles into smaller molecules, aggregation into microscale molecules, or removal (phytoremediation) of particles from soils. Interestingly, phytoremediation is one way of removing contaminants from soils, and also a way of producing nanoparticles by using plants. Recent research has led to a new method to mine precious metals, such as gold, by removing them from soils in which they have accumulated. In one experiment, alfalfa plants were shown to be effective in synthesizing gold nanoparticles from a non-nanoscale gold cyanide solution in which they were growing (Gardea-Torresdey et al., 2002). This is a case of phytoremediation and phytomining at the same time. Future research in agricultural and biological science might examine the effect of nanoparticles on such basic processes as photosynthesis, or on the interfacial chemistry of nitrogen fixation—a process in which bacteria make atmospheric nitrogen available to the plant roots by converting it into ammonia. Even mundane processes such as decomposition, where organic matter is broken down for nutrients for plants, could be affected. If nanoparticles adversely affect these processes, the health of the biosphere could suffer. These processes require interactions at the molecular level. Particles on the nanoscale occur naturally, such as in volcanic fumes, and some are produced incidentally, as in diesel engine combustion. So natural nanoparticles have been around for a long time, and have not interfered with the processes as far as we know. But nanotechnology will introduce engineered particles with new sizes, shapes, and properties into the mix.

8

In a paper which caused alarm in the popular media, two scientists argued that alumina particles in soil inhibited root elongation in five different plant species. See Yang and Watts, 2005. However, see the “Comment” in the same journal by Murashov (2006) which claims that Yang and Watts overstated the implications of their experimental results.

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Animal Life

Turning from plants and processes to animals, we find the current state of research is quite narrow, and focused primarily on pulmonary, cardiovascular, and dermal studies that are presumed to relate directly to human health.9 Nonetheless, this research paints a picture of what effects there might be on all animal life. In a review of the literature on the animal effects of carbon nanoparticles by a group of scientists in Europe, they (Fiorito et al., 2006) concluded that “we have a lack of knowledge of the environmental consequences of nanotechnology and we are not able to anticipate unintended consequences.” The same report cites the ability of carbon nanoparticles under 50 nm in size to translocate into cells and interact with enzymes and proteins. Such inhaled nanoparticles can go from the lungs into the blood, and would then be dispersed through major organ systems. Carbon nanotubes—some of which have a structural similarity to asbestos fibers—have been shown to produce inflammation and fibrosis in the lungs of mice, and even to damage mitochondrial DNA in heart tissue (Lam et al., 2006). The C-fullerene nanoparticle has also been shown to translocate into the nervous system and brains of fish, and to cause oxidative stress (Oberdörster, 2004). The same type of particle, when administered orally to rats, is distributed widely throughout the body, crosses the blood-brain barrier, and is not quickly eliminated from the body (Fiorito et al., 2006, 595). In vitro experiments have shown that several types of nanoparticles are cytotoxic—toxic to cells. Nanoscale titanium dioxide, which is found in some sunscreens, has been shown in human trials to penetrate the skin, depending on its emulsion and the condition of the skin (Tsuji et al., 2006). As alarming as these findings may seem, we must keep in mind that many factors play a role in the toxicity of nanoparticles for animals. Surface coatings, alteration by UV light, shape of nanoparticles, concentration, exposure, and the mode of action (how a nanoparticle interacts biochemically once it enters an organism) are all important factors in determining toxicity, and so at this point “no one study should be interpreted as definitive” (Holsapple et al., 2005, 16) One peculiar fact is that some nanoparticles are not “scavenged” by the mammalian immune response known as phagocytosis—a cellular process that removes pathogens, dust, and cellular debris (Fiorito et al., 2006, 595). Through scavenger cells called macrophages, found mostly in the lungs, liver, and lymph nodes, phagocytosis rids the body of particles that could prove toxic if left alone. It is not known why the macrophages leave nanoparticles alone; they could be non-toxic, or they could be so small that the body does not recognize them as toxins. While some fears about the toxicity of nanoparticles for animals seem well founded, there is also hope that applications in nanomedicine will provide great

9 One commentator noted that “very few papers have been published regarding the effects of nanoparticles on…microorganisms, invertebrates and vertebrates from terrestrial and aquatic habitats.” See Stone et al., 2006.

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benefits for humans. Diagnosis of disease, drug delivery, and medical imaging are some of the areas in which nanotechnologies can be and have been employed (Seaton and Donaldson, 2005). The initial euphoria over a future with self-replicating “nanobots,” deployed in the body to cure every imaginable problem, has now been replaced by more sober thinking. Interestingly, it is the body’s inattention to nanoparticles that makes them promising for targeted drug delivery. Since the macrophage cells do not clear away nanoparticles, some biodegradable types of nanoparticles have been used successfully to deliver drugs without causing lung inflammation (Dailey, 2006). The hopes for improvements in human health are not the only reasons in favor of further development of nanotechnology. Huge commercial interests are also at play. The promise of nanotechnology is that, by engineering exactly the molecules we want, with physical-chemical properties tailored to the tasks that engineers wish to achieve, we will be able to re-make the industrial revolution. Unconstrained by the shape and size of nature’s preferred molecular structures, materials science, medicine, biotechnology, and many other fields will enter a new era in which almost anything is possible. Corporate profits and an improvement in the quality of life of humans are driving factors in the promise of nanotechnology. What could be wrong with such progress?

6.6

A Leopoldian Response

Despite his rhetoric extolling the virtues of wilderness, Leopold did not advocate a “back to nature” ethics. He was not naïve when it came to the fact that humans have entered the anthropocene—a new geologic era in which the earth is dominated by human-caused change. Therefore, there are no (or very few) “wild” areas left that are untouched by the effects of human populations. He readily admitted (Leopold, 1987, 170) that “all intergrades of artificiality exist.” So any objections to nanotechnology from the holistic point of view cannot be reactionary, at least according to the Land Ethic. It is at this point that we can see clearly that holism does not imply an unworkable principle of “non-interference” with natural environments. However, there are a few salient points, based on the science that is now available, that would define the holistic response to nanotechnology. First, we need to investigate what exactly nanoparticles do once they are in ecosystems. What, for instance, is the incidence of transport and uptake in plant and animal cells? Do the currently known dangers to mammalian cardio-vascular and pulmonary organs transfer to non-mammalian species? Do only certain nanoparticles accumulate, and if so do they interfere with life processes at the cellular or organic levels? Do nanoparticles break down into stable molecules, or will degraded particles from them pose a further risk? The fact that these questions remain unanswered has led a group of leading scientists (Tsuji et al. 2006, 42) to declare that “technological developments and applications are out-pacing research of health and environmental risks.” This is precisely the kind of development without foresight that the holistic view warns against.

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The answers to these and other important questions will only be found in basic scientific research on land health and functions. For adherents to the Land Ethic, a responsible path for research would be to discover the “deferred reactions” of which Leopold wrote, and to be able to calculate the time scale during which we will be confronted with them. But since we live in the anthropocene, there is no sense in which nanotechnology is radically new. It is just another addition to the world of artifacts, which includes things such as buildings and roads, but also other things that would not exist were it not for human intervention, such as most domesticated species. It could well be that nanoparticles, once dispersed in the broader environment, become something like molecular trash—annoying, but otherwise harmless. They could also end up harming us in ways similar to dioxins and PCB’s.

6.7

Balancing Promise and Peril

Contemporary proponents of the Leopoldian view have been accused of advocating “eco-fascism” on grounds that all parts of the land community—humans included— have equal and merely instrumental value (Lo, 2001). Only the whole is of intrinsic value. Such criticisms are generated by “tradeoff” scenarios in which, so the charge goes, human interests or even lives might need to be sacrificed for the sake of the whole. At the least, it is claimed, such an environmental holism will have a tendency to ignore the interests and needs of humans in order to look after ecosystems and soils. We are asked to imagine that humans would have to be sacrificed to save other animal species or, even worse, to contemplate harming humans for the sake of plants and ecological processes. Such a holism is thought therefore to reduce to absurdity, or at least to constitute a misanthropy of potentially barbaric proportions. I find these charges unreasonable, mostly because they misconstrue the biological relationship between one of the parts of the land (human beings) and the other parts. On the most basic level, we humans cannot afford to poison the food that we eat, and this food comes from the other parts of the land community. We humans are, after all, predators. But predation is not domination, and no part of the land, from the point of view of evolutionary history, has the right of domination of the others. By the same token, the land ethic does not advocate “sacrifice” of any of the parts. Leopold’s notion of right (and wrong) is better expressed as a claim about the world in which we would want to live. Domination of the interests of some members of the land community is ultimately self-defeating. Even if humans could survive in an environment devoid of plants, phytoplankton and other animals—one therefore incapable of the only life-sustaining processes we know—the system of systems he calls the land would no longer exist as such. Would humans want to survive under such a scenario? The complex relationship described by the land community is not the zero-sum tradeoff imagined by Leopold’s critics. The answer to the “deceptively easy” question with which I began, for the environmental holist at least, is that the land is the only thing worth protecting unconditionally. This obligation of protection

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would also afford protection to human life. In fact, given the complexity of ecosystem relationships and our current inability to foresee the “deferred reactions” of nanotechnology applications, this view might best protect human life. The caveat, however, is that such an ethic will not guarantee the maximization of potential profits from nanotechnology. Environmental holism does allow tradeoffs of parts of the land, but profits do not figure in the land community, and so they have no moral status in it. Now that we see what environmental holism would actually sacrifice, and what it would save, we are in a position to return to the issue posed in the beginning of this essay: the defeasible nature of obligations to parts or members of the land community. The obligations in the Leopold’s ethics are not similar to strict deontological rules which hold unconditionally. Any obligation to a member of the land community (individual or species) can be overridden, in principle, if the health of the land is at stake. This type of environmental holism does not propose any a priori method to determine the defeating conditions for obligations. It does however rely on ecological science to establish the hierarchy of obligations, and allows that once those determinations are made, we ought to abide by them until the science says otherwise. If it ends up that the only engineered nanoparticles that are released in abundance into the environment are deemed harmless to plants, animals, soils, waters, and earth-system processes, then no objection from the point of view of the holist would be forthcoming. I believe, on the contrary, that some nanoparticles will be deemed harmful, if they have not already been shown to be so. This alone is not a telling argument against the technology—or if it is, at least the same argument holds against the production of greenhouse gases, the use of pesticides and herbicides, and other environmentally harmful practices. What would be necessary to make a compelling argument against the next generation of nanotechnology would be studies of a baseline of land health, the functions and roles of the members of the land community in their contribution to land health, and identification of the essential parts in relation to the whole. For this reason, environmental holism of the sort that Leopold advocates will always be tied to the science that informs us about those issues. In addition, we would need to know that there are no significant “offsetting” benefits to the environment that might come from nanotechnology. Recall the earlier example which compares extra-large private vehicles to public transit buses. Both kinds of vehicle cause some environmental harm, but the buses more than compensate for the harm by taking other private vehicles, in effect, off the road. Similarly, we might put up with some nanoscale pollution if the development of those same nanotechnologies allowed for cheap and clean energy production, the amelioration of human and animal disease, the phytoremediation of soils contaminated by heavy metals, and other woes. There is some reason to believe that nanotechnologies could be developed to reach these goals (Jones, 2007). This analysis of “promises and perils” suggests that the proper ethical method to be employed here is the cost-benefit analysis. In its traditional form, however, the cost-benefit analysis would not be applicable to this ethical choice. The problem is that land health and the functions and roles of parts of the land are very unlikely to be quantifiable on

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one scale of measurement. Further, the metric of “willingness to pay” that is employed in cost-benefit analysis is nonsensical when applied to most parts of the land community. Finally, many of the parts of the land community are not “substitutable,” and one crucial assumption of cost-benefit analyses is that goods are substitutable. For business decisions, it may make sense to compensate a neighborhood for increased pollution by paying them money, or building a nearby park. In ecological decisions, it is rare that we can switch out one species for another, or expect that one natural process takes the place of another. Though I mentioned in the beginning of this essay that I would not attempt a defense of environmental holism against other anthropocentric ethical theories, I did indicate that human interests would still be protected, if only incidentally, by this kind of holism. What I meant there can be seen in the essentially conservative nature of environmental holism. Any technological change that harms the parts of the land is likely also to harm humans, in the end. The underlying assumption of the view is that human interests do not depart so seriously from the interests of other animals and (if it makes sense so to speak) of plants. True, those other entities do not have refined interests in art, music, and other products of human culture. But what is crucial to remember is that these cultural products will not disappear if nanotechnology is inhibited from developing beyond the current state. And while it is also true that the great sums of profit that industry is anticipating from nanotechnology will fail to materialize if it is stopped in its tracks, environmental holism does not advocate a priori that any form of technology be blocked. At most, what the environmental holist advocates is that any technology be limited by considerations of the health of the land, and that sound ecological science remain vigilant to the signs of ecological harm.

References Bentham, J. 2005. An Introduction to the Principles of Morals and Legislation. Oxford: Oxford University Press [1789]. Boyer, P. S. 1994. By the Bomb’s Early Light: American Thought and Culture at the Dawn of the Atomic Age. Chapel Hill, NC: University of North Carolina Press [1985]. Dailey, L. A. 2006. Investigation of the proinflammatory potential of biodegradable nanoparticle drug delivery systems in the lung. Toxicology and Applied Pharmacology 215.1: 100–108. Dworkin, R. 1984. Rights as Trumps. In Theories of Rights, ed. J. Waldron, 153–67. Oxford: Oxford University Press. Fiorito, S et al. 2006. Toxicity and biocompatibility of carbon nanoparticles. Journal of Nanoscience and Nanotechnology 6.3: 591. Gardea-Torresdey, J. L et al. 2002. Formation and growth of Au nanoparticles inside live alfalfa plants. Nano Letters 2.4: 397–401. Holsapple, M. P et al. 2005. Toxicological and safety evaluation of nanomaterials: Current challenges and needs. Toxicological Sciences 88.1: 12–17. Jones, R. 2007. Can nanotechnology ever prove that it is green? Nature Nanotechnology 2: 71–72. Kelly, E. F et al. 1998. The effect of plants on mineral weathering. Biogeochemistry 42: 21–53.

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Lam, C. et al. 2006. A review of carbon nanotube toxicity and assessment of potential occupational and environmental health risks. Critical Reviews in Toxicology 36.3: 189–217. Leopold, A. 1987. A Sand County Almanac. New York: Oxford University Press [1949]. Lin, H. 2003. Hydropedology: Bridging disciplines, scales, and data. Vadose Zone Journal 2: 1–11. Lin, J et al. 2006. Mechanical behavior of various nanoparticle filled composites at low-velocity impact. Composite Structures 74.1: 30–36. Lo, Y.S. 2001. The land ethic and Callicott’s ethical system (1980–2001): An overview and critique. Inquiry 44: 331–358. May, L. (Robert). 2005. Threats to Tomorrow’s World. President’s Anniversary Address. The Royal Society, London. Mill, J. S. 1989. On Liberty. In On Liberty and Other Essays, ed. S. Collini, Cambridge: Cambridge University Press [1851]. Murashov, V. 2006. Comments on “Particle surface characteristics may play an important role in phytotoxicity of alumina nanoparticles.” Toxicology Letters 164.2: 185–87. National Research Council. 2001. Basic Research Opportunities in Earth Science Washington, DC: National Academy Press. Oberdörster, E. 2004. Manufactured nanomaterials (Fullerenes, C60) induce oxidative stress in the brain of juvenile largemouth bass. Environmental Health Perspectives 112.10: 1058. Seaton, A. and K. Donaldson. 2005. Nanoscience, nanotoxicology, and the need to think small. The Lancet 365.9463: 923–924. Singer, P. 1990. Animal Liberation. New York: Random House [1975]. Stone, V et al. 2006. Suggested strategies for the ecotoxicology testing of nanoparticles. In lifecycle analysis tools for “green” materials and process selection. Materials Research Society Proceedings 895: 173–186. Thomas, K. and P. Sayre. 2005. Evaluating the human health implications of exposure to nanoscale materials. Toxicological Sciences 87.2: 316–321. Tsuji, J. S et al. 2006. Risk assessment of nanoparticles. Toxicological Sciences 89.1: 42–50. Yang, L. and D. J. Watts. 2005. Particle surface characteristics may play an important role in phytotoxicity of alumna particles. Toxicology Letters 158.2: 122–132.

Chapter 7

Nanotechnology’s Future: Considerations for the Professional1 Ashley Shew

7.1

Introduction

At a previous job not too long ago, a former colleague of mine was indignant when he came into work. He had been to a department store and had seen “nanopants.”2 When he asked the store clerk about these nanopants, the clerk told him that the pants had miniature robots in them! (Personal conversation, July 2003) Professionals in nanotechnology might need to clear up some misperceptions about nanotechnology. Nanotechnology holds many hopes, but first the field must face some reality. Concerns have already been raised about toxicity of nanoparticles and environmental dangers. Products said to be using nanotechnology are already in the consumer market, from sunscreen to stain resistant pants. Nanotechnology could suffer great backlash if any incidents or tragedies occur. Having a strong code of ethics could aid understanding between nanotechnologists3 and could help save time in response to any contentious situations. By developing a code of ethics, the field would have some group identity in which ethical dilemmas and questions of technology might be framed. Further, nanotechnologists could take the initiative in self-regulation, rather than be forced to meet governmental standards later.

1

This paper is excerpted from my Honors Thesis in the Department of Philosophy at the University of South Carolina, which was done under the direction of Ann Johnson and Davis Baird. I owe these two people great thanks for helping me think about things and organize those thoughts. This paper also benefited from conversations with people at meetings of the International Association of Nanotechnology conferences at the University of South Carolina, and discussions with Chris Toumey, Loren Knapp, and Kathryn Vignone. 2 Nanopants—there are several different brands—have a stain-resistant coating that was engineered on the nanoscale. 3 I use the word ‘nanotechnologist’ instead of ‘nanoscientist’ here because of the way the governmental structures, particularly the US National Nanotechnology Initiative, have emphasized nanotechnology, which they define as including both basic nanoscience and nanoengineering as they define the word nanotechnology. I take the word ‘nanotechnologist’ to encompass professionals working with a concentration on the nanoscale that come from both science and engineering backgrounds.

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Nanotechnology is currently the topic of research for a multidisciplinary group of people. Because of disciplinary diversity in nanotechnology, there is no one understood set of ethical norms to which these practitioners hold themselves. Scientists and engineers have different understandings of what ethics involves; even science sub-disciplines generate different understandings. To promote public trust and to foster understanding within the community, nanotechnologists need to have a code of ethics from which to work. Codes of ethics are usually an important part of the process of professionalization, but the fact that nanotechnologists come from such diverse backgrounds raises the question of how the field might form a disciplinary identity and create a code of ethics. I do not advocate a strong professional development, but forming some sort of loose coalition of professionals would help this emerging and exciting field. This intent of this paper is to address the emerging field of nanotechnology and the problems that that are likely to assail it unless it develops a clearer professional identity. Right now, nanotechnologists come from many fields, working with different understandings of phenomena and of proper practice, and any identity of nanotechnology that researchers have comes largely as a result of funding, but there is much more richness in which an identity for nanotechnology could be formed. Nanotechnology can challenge the traditional hierarchy of the sciences and is unique in its aims of control and manipulation of the atomic scale. In order to ease frictions that might occur in attempting professionalization, I will describe the development of two professions and their respective identities with an aim at having some foresight as to the problems that might arise in disciplinary formation for nanotechnology (Section 7.2). After developing a model for forming a disciplinary identity, I will explain the role of codes and the differences of codes of ethics between professions, so as to aid nanotechnology in this development (Section 7.3). Finally, I will further explain the uniqueness of nanotechnology and develop a code of ethics based on its aim (Section 7.4). Though I believe practitioners of nanotechnology should be involved in the process of writing a proper code of ethics, this paper should be of aid to any professionals in embarking on such a project.

7.2

Professions and Development

Professions are not static entities. Subject to pressures and disasters and politics, professions develop and evolve for many reasons. Professions are very much a product of their time and place. The physician’s role perhaps illustrates this most clearly. The role of a medical professional has changed radically over time and place—from shaman to limited healer to director of health to an overseer of condition and wellness. Throughout most of the time in Western society, a physician could do little to help someone and would only be called upon in the most dire of circumstances, if at all. Now, we see our personal physicians for any small ailment and even for yearly physicals. We see our physicians whether we are ill or not, something that is very different from previous times. But, the role of physician continues to change.

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As medical doctors are becoming more specialized, nurse practitioners—trained in the field of nursing, not medicine—are often taking the place of primary care physicians, seeing patients for common ailments and administering treatment or directing them to specialists as needed. Medicine as a field is changing due to exterior forces, like the pharmaceutical industry and insurance policy, and interior forces, like the greater specialization and the use of medical enhancements. This section outlines the development of three professions and examines how these professions developed their professional codes of ethics. The professions to be examined are software engineering and nursing. These professions, each from a different area of technical study, encountered different problems in forming their identity. Through looking at these three professions and their development, I will: discuss the barriers and difficulties in professionalizing; frame the development of ethical codes with special consideration of aim; and suggest an ideal model for professionalization. The cases of professionalization are not tidy, linear stories that give us a simple model to follow, but, from reflecting on the difficulties and highlighting certain properties involved in the professionalization of certain fields, the hope is that the process of identity formation can go more smoothly for emerging fields, like nanotechnology.

7.2.1

Software Engineering and Its Development

In 1968, the first software engineering conference took place. This conference was set to discuss the “software crisis,” in which the computer industry was beset with trouble in constructing “large and complex software systems” (McClure, 2001) There were two such conferences, sponsored by NATO, to help solve this “software crisis.” One met in 1968 in Munich and one in 1969 in Rome;4 over 50 participants from industry and academia came to discuss the problem. In 1969, Computer Decisions published a short opinion piece by Franklin Kuo (1969) entitled, “Let’s Make Our Best People into Software Engineers and Not Computer Scientists.” His thesis should be apparent by his title: he observes that computer science departments “do not emphasize enough the practical aspects of computer systems design” (Kuo, 1969). These calls for software engineering and software engineers were serious, yet they went unheeded for over two decades. The Software Engineers Association of Japan was established in 1985, but it would take until 1993 for enough interest to be generated in the United States. In 1993, both the IEEE Computer Society Board of Governors and the Association for Computing Machinery (ACM) endorsed motions to address questions of professionalizing software engineering (IEEE Computer Society, 2004). The IEEE Computer Society and ACM decided to work

4

McClure, 2001. The Rome conference was on “Software Engineering Techniques.”

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together on this project, designating three task force areas for investigation: “Body of Knowledge,” “Ethics and Professional Practice,” and “Education” (IEEE Computer Society, 2004). By 1995, the Task Force on Software Engineering Body of Knowledge had started conducting a survey online to find out the educational background and knowledge of people who do software engineering. What they found was a variety of educational levels and experiences in the field (Task Force on Body of SE Knowledge, 1997). Also, there was no general consensus as to the knowledge that novices in the field should have (Task Force on Body of SE Knowledge, 1997). Gary Ford and Norman Gibbs (1996) of the Software Engineering Institute of Carnegie Mellon also reported a lack of uniform experience among software engineers in their technical report on “A Mature Profession of Software Engineering.” Ford and Gibbs reported that there were 13 undergraduate software engineering (SE) programs in the UK and 3 in Australia, though none existed in the United States.5 The educational background of those doing tasks of software engineering has varied a great deal. Though many have backgrounds in computer science, math, or computer engineering, some have no formal or college degrees in a related field. Diversity in educational background for those with degrees doing software engineering also varies, with programs in computer science varying as to the amount of exposure to software engineering a student might receive. With such a wide array of formal exposure to software engineering and no bachelor’s program existing on the subject until 1996 in the US, software engineers have had no one body of knowledge or experience. The survey of software engineers done in 1996 by the IEEE/ACM Task Force on Body of Software Engineering Knowledge showed that defining the body of knowledge that software engineers are using is difficult. With most respondents working in SE for ten or more years, one would expect more agreement as to what novices in the field should know. There were only five expected tasks items were agreed upon by over 70% of those surveyed, one of the tasks involving being able to name and describe six common computer peripherals. One other agreed upon task included being able to describe the fundamental data structures of hash table, linked list, tree, graph, stack, and queue—something most high-schoolers taking advanced computer science could answer. Defining the body of knowledge needed to do software engineering was not a simple task for the bodies that were pushing for the formation of a profession of software engineering. This was a challenge to the professionalization that was addressed by Ford and Gibbs in “A Mature Profession of Software Engineering” and by institutions, like Rochester Institute of Technology, that developed the first US bachelor’s programs in the area. Developing a curriculum and standardizing knowledge helped the profession develop further, but it was a slow process that took years for the profession. Currently, the Accreditation Board for Engineering and Technology accredits

5

Rochester Institute of Technology was slated to begin offering a bachelor’s program in SE, the first of its kind in the US, when Ford and Gibbs were published.

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programs in software engineering, with six now-accredited bachelor’s programs in software engineering in the US (ABET, 2004). Of course, six programs out of all the institutions in the US is hardly an impressive figure, but software engineering is on its way. One aspect of professionalization in which software engineering has become well-developed is its code of ethics. Developed by the joint effort of IEEE and ACM and currently in version 5.2, the Software Engineering Code of Ethics has been accepted by groups in Australia and other places as the code of ethics for software engineers (Australian Computer Society Media Release, 2004). The Code has even been published in eight different languages (Australian Computer Society Media Release, 2004). The Code was published for viewing by the IEEE and ACM in version 3.0. After getting some feedback, the Code was updated until version 5.2 was approved by both the ACM and the IEEE Computer Society in 1999 (Gotterbarn et al., 1999). Alterations to the Code between versions 3.0 and 5.2 include reordering the eight principles listed and adding a shortened version at the front for quick review (Gotterbarn et al., 1999). My selection of and focus on Software Engineer’s Code of Ethics is not trivial. Software Engineering suffered from a crisis that could be analogized to the situation of nanotechnology. Software engineers were needed not to theorize about computer science, but to develop and implement good systems. Nanotechnologists are needed not simply to gather information about the nanoscale, but to use the properties therein to manipulate and create. Software engineers had a real challenge in developing their code of ethics because of resistance in the field, but they were able to organize and agree on the values of the profession. Nanotechnologists will also see some apathy among practitioners, but this can be overcome by commitment and willingness to involve the public. Software engineering has been a tough field to professionalize because it lacks a seminal figure in its professional mythology. Without reference back to a single figure or plan that embodies the aims of the profession, a disciplinary identity will not easily be established. Nanotechnology already has some possible founding figures, but the stories around these figures and their relation to nanotechnology are contested.6

7.2.2

Professional Nursing and Its Development

Professional aims and mythological characters can play a strong role in the life of a profession. The profession of nursing is often traced back to Florence Nightingale. Though nursing existed before Florence Nightingale with nuns and untrained caretakers of the ill, her figure transformed nursing by taking an active role in patient care, a different role than that of the medical doctor or mere assistant to the 6 I have worked on this problem in an unpublished paper, and Christopher Toumey of USC has written several papers on the trouble with Feynman as a founding figure in nanotechnology.

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doctor. Nightingale’s insistence that nursing is not a position subservient to the physician continues to be emphasized in nursing literature and frames discussions of nursing professionalism today. In Prologue to Professionalism, Louise Fitzpatrick (1983) writes: While the medical profession was busily placing the nursing role in a passive and subservient position, Florence Nightingale was carving a unique independent role for nursing. Miss Nightingale believed that “No man, not even a doctor, ever gave any other definition of what a nurse should be than this – devoted and obedient. This definition would do just as well for a porter. It might even do for a horse. It will not do for a nurse.”

No nursing text is complete without reference to Nightingale as the founder of modern nursing. This consistent character of nursing has helped to shape the ethic and the identity of nursing. She continues to provide guidance for the professional identity of nursing. In “Florence Nightingale: Yesterday, today, and tomorrow,” nurses Karen Dennis and Patricia Prescott (1985) report that, in a study of nursing practice, nurses “addressed the same areas Nightingale had deemed to be important. Some of the particulars have changed because of the changing times, but the central themes remain.” In researching this portion of this paper, I found a section of the library’s nursing section practically devoted to Nightingale. Nursing has perhaps the most strongly defined character that has helped anchor and define the profession. Scholarship on Nightingale’s works, life, and teaching continue to be pursued because of her prominence in creating the understanding of nursing that endures from her legacy (Dossey et al., 2005; Vicinus and Nergaard, 1990; Bullough et al. 1990). There is one other prominent feature of the professional identity of nursing that I would like to highlight, namely the ethics of nursing and its development. Physicians have traditionally framed their professional ethic in terms of respect for autonomy, nonmaleficence (not harming others), beneficence (benefiting others), and justice (Beauchamp and Childress, 1994). This “principlism,” as it has been called, seems very masculine in its emphasis on principles of action and is certainly a justice-oriented account of ethics. The profession of nursing has framed their ethic in a different way from this principlism, taking an approach more closely related to feminist and narrative accounts of ethics. Feminist accounts of ethics critique traditional accounts of ethics for approaching individuals outside of their proper context; we are not simply agents acting on principles. Feminist ethics focuses on shifting our focus from acting on principles to acting upon care, compassion, and within a context. Narrative approaches to ethics bring further focus to the context in which we experience dilemmas and are faced with ethical decision making. These approaches seem to cohere better with the way nurses see their role in patient care. Originally, the ANA Code for Nurses put the purpose of nursing into the terms of principlism, but nursing was also influenced by the work of Lawrence Kohlberg and Carol Gilligan, and so, when nursing was being taught in classes, nursing was constructed in terms of applying patient care (Fry, 2004). Sara Fry of Boston College’s School of Nursing even suggests that the theoretical frameworks taken from medicine actually hurt the development of nursing ethics. Nursing, with its necessary emphasis on daily care of patients, makes more sense within a framework

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of care-based (or feminist) ethics. Generally nurses are thought of as dealing with patients and responding to their needs better than doctors.7 Writing on Nightingale points out that in her era and in our era, “the patient is the focal point of nursing care” (Dennis and Prescott,1985). Nurses are supposed to be responsive to their patients, working to provide the proper environment and care for each individual patient. The theoretical model of physicians simply fails to work for the professional situation of nurses. Interestingly, Fry, in her writing on nursing ethics, brings up the work of Carol Gilligan, a psychologist known for identifying the moral development of females, and Nel Noddings, a prominent feminist ethicist, in talking about developing a care-based ethic for nursing, explicitly challenging “theories [that] espouse a masculine approach to moral decision making and ethical analysis” (Fry, 1989). Nursing developed its codes of ethics during the 1950s8 and modeled them after the then-current ethical codes of physicians (Fry, 2004). Fry points out that these theoretical frameworks actually inhibited the development of nursing, but more recent contributions in the field have set out to enrich the nurses’ view of professional ethics. The theories of medicine kept nurses from seeing their practice as independent and vitally important to healthcare. Nursing has become more attuned to the developments associated with care-based approaches to ethics in philosophy, and Fry has been among those working to bring these approaches into nursing ethics to more properly describe nursing practice. The ethics used for physicians are not those employed in everyday nursing practice. Fry (1989) argues that “what is appropriate to the practice of medicine or is argued as the moral foundation for the physician/patient relationship is not necessarily the case for the practice of nursing or the nurse/patient relationship.” Fry and others have argued that caring provides a better foundation for professional nursing practice, that this is the ethical approach that actually reflects the practitioners’ approach. They point to the contextual differences between medical practice and nursing practice and the misfit of biomedical approaches in their application to nurses. The very prominent founding figure of professional identity and the discussion of ethics in nursing both demonstrate how this field has matured. Even its discussion of ethics invoked the name of Nightingale to aid in sorting out their aims of the practice. By separating themselves from medicine and by the use of this strong character, nursing has developed into a strong profession with a strong professional identity. Nanotechnology may encounter problems if it tries to simply adopt the ethics suggested by bioethicists to deal with bioengineering9 or by environmental ethicists to aid the engineering professions. Nanotechnologists need to be wary of the simple borrowing of principles. 7 Though this may be disputed—there are certainly good doctors who do pay attention to patients—physicians are taught about body parts and disease patterns, not about patient care. There are many examples of how the medical profession desensitizes physicians to people. 8 The International Council of Nurses developed its Code of Ethics for Nurses in 1953, revised in 1965, rewrote in 1973, and reaffirmed in 2000. The American Nursing Association developed its Code for Nurses in 1950 and revised in 1985 and revised in 2001 with interpretive statements. 9 Matte Ebbeson suggested this very thing at USC’s NanoEthics Conference, 4 March 2005.

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Thoughts on Professional Identity

A strong professional identity relies on a conscious movement to develop a field, anchoring the field to a character and shaping practice through a set of values and goals. A common aim, often mythologized through a founding figure, is central to solid professional development, but will this bear out in nanotechnology? Professions are borne out of certain times and places, reacting to pressures and developments in their day. Software engineering needed (and might still need) to standardize the knowledge of the field. Nursing had to define itself as independent from the practice of the physician to succeed as a profession. What will happen to the emerging field of nanotechnology? What problems might this field face? Currently, funding sources seem to define what nanotechnology is (and who researches it), but this type of forced identity will only lead to cynicism on the part of researchers.10 Nanotechnology does seem to have a special aim with particular social ends and implications. It is a field that should form a distinct identity, one that is not so much separate from other sciences as it is a fusion of the ways of knowing, thinking, doing, and designing used in related branches of science and engineering. There is a great opportunity to develop these exciting ways of studying the nanoscale, and the time for a conscious shaping of the field on the part of nanotechnologists is now.

7.2.4

The Problem of the Founding Figure of Nanotechnology

Nanotechnology has two founding figures that are used in standard histories of nanotechnology, namely Richard Feynman and Eric Drexler (Baird and Shew, unpublished manuscript). Neither of these figures is actually very healthy for the development of the field. Feynman would be a really great character with his charisma and great academic credentials, but his contributions to nanotechnology are only in hindsight, and few researchers in the early days of nanotechnology had ever heard of his now famous 1959 speech to the American Physical Society by the title, “There’s Plenty of Room at the Bottom” (Toumey, 2005). Eric Drexler lacks the charisma of Feynman, and, though he might be credited with popularizing nanotechnology and with introducing the ideas that shape the aim of nanotechnology, many researchers in the field have tried to distance themselves from Drexler because his popularization of nanotechnology created unrealistic expectations (Toumey, 2005). The figure not as often mentioned in the general histories of nanotechnology that Christopher Toumey suggests might make the best founding figure is Gerd Binnig, co-inventor of the Scanning Tunneling Microscope (1981) and the Atomic Force Microscope (1986), instruments that strengthened the reference

10

Ann Johnson, personal conversation, 9 February 2005.

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to Feynman speech (Baird and Shew, 2004). This move might be useful to help nanotechnology form a stronger and more narrative identity. Since nanotechnologists rely on instruments to get them to their area of study, the inventor of a few of the field’s instruments would not be a poor founding figure. In addition to considering the narrative identity of the field, nanotechnologists would be smart to start discussing the shared values of the practitioners.

7.2.5

The Problem of an Ethical Code

Due to nanotechnology’s interdisciplinarity, developing a code of ethics to express the aims and values of the field may cause friction. Because of the different ways of understanding ethics in science and engineering, a code of ethics for nanotechnology would allow for a greater coherence of approach in the field. Though one may argue that a profession cannot be formed around nanotechnology in the same way a profession could be developed a century ago because disciplinary boundaries are already in place, a code of ethics can work to inform a heterogeneous research group about the values they corporately hold. In the same way the IEEE Computer Society and the ACM set up an explorative committee to look into developing software engineering into a field of its own, the American Chemical Society and the International Association of Nanotechnology11 and other nanotech-oriented groups have an opportunity to start exploring the identity of nanotechnology to prevent cynicism and to promote professionalism among researchers. There are many benefits to developing a code of ethics that could help nanotechnology develop its professional identity. By fostering communication among practitioners, a code of ethics project might work to help this mixed group work together toward an objective. How will these professionals work together, given their different backgrounds? By looking at the values some of the contributing professions hold, perhaps we can see how these different professionals might from an appropriate code of ethics for nanotechnology.

7.3

Codes of Ethics

Codes of professional ethics are employed for many reasons. Sometimes an incident occurs and professionals feel the need to reassure the public as to their position or to instruct novices in the field on how to behave properly. Codes can signal the solidification of a profession and strengthen the values of a profession. Ethical codes

11

Information about this association of those interested in nanotechnology can be found at http:// www.ianano.org.

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can be used to point to areas of caution or concern. Usually, in making a code, professionals within the field meet together to discuss the values they hold and how they want to express them. These codes also help define a profession so that it can separate itself from others performing the same service and protect against rogues, which is important in protecting against catastrophe.12 Codes also buttress the ethics of individuals in relation to larger bodies in which they work, like university research centers and industry. By picturing themselves as nanotechnologists with a shared value system, individual nanotechnologists are in a better position to stand up to wrongdoing. Nanotechnology research often is performed by diverse, multidisciplinary groups. A code of ethics for nanotechnology might be useful as a way to create dialogue about social and ethical implications among the professionals who work in the field. As scientists and engineers are trained and cultured differently within their respective disciplines, a code of ethics might prove useful in creating some common ground between fields. Listing areas of caution for the nanoscale might help researchers keep in mind the ramifications of the work. A code might serve to initiate dialogue within the nanotechnology community about professional responsibility and duty. Further, cementing an identity in this way is preferable to an identity formation in relation to funding sources. If nanotechnology is defined simply in terms of funding, cynicism among practitioners will become commonplace, which might lead to problems with proper practices in nanotechnology. If nanotechnology is about funding, the professional identity of those researching in the field will not act as a deterrent against improper behavior. Developing a code might be particularly important in nanotechnology research. Catastrophes could occur (Hirshler, 2004; Amato, 2004; Weiss, 2004), and there has been public speculation over possible catastrophes in popular entertainment.13 Even simply the public perception of a catastrophe (whether or not based in reality) can be a problem. A code can alert those in nanotechnology to the perils that might arise from working at the nanoscale and reassure the public that some thought about consequences and professional responsibility has been put in place. Ideally, a code could breed a sense of community that might promote responsibility—something imperative for those working with the dangerous or unknown. Identity matters because situations will occur, and a community response determines how the situation will be handled. A code for nanotechnology might include values from both engineering codes and scientific codes of ethics, as both fields are working together on this scale. However, since these codes express different values and aims for science and engineering respectively, one cannot simply lift a code from chemistry and slap it on nanotechnology. More thought is needed to articulate a code focused on nanotechnology.

12

This “protection against rogues” can have an exclusionary effect, which can be negative for some groups. 13 Michael Crichton’s Prey and the 1995 movie Virtuosity (among others).

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Codes of Ethics between Professions

The codes of ethics in science and in engineering differ in certain systematic and discernable ways. Engineers tend to have more structure in their codes, and they also express concerns in different arenas than scientists do. Scientists are focused, perhaps rightly, on professional behavior in research, while engineers are bent on safety. Engineers have typically been more oriented towards minimization of public harms, while scientists are not directed to look at the public in such a way. Many professional organizations for scientists have codes of ethics or codes or conduct for their members. Though having no legal force (except through malpractice law), these codes outline proper behavior in their fields. These codes serve as guidelines for professionals and students and reassurance to the public as to the aim of the profession. If the group that has the code is powerful or widespread, the violation of the codes can be devastating to a career. Codes and ethical norms have force when a community upholds them and regards their violation as awful. Codes and guidelines published by scientific societies focus on research and academic integrity—concerns that are pertinent to the science community. Engineering codes take a different form. When engineers think of codes, they think of building codes and specifications for design,14 but no code of ethics could ever be that specific and still be reasonable. The number one thing engineering codes emphasize is public safety. Public safety is probably of prime importance because engineers must be relied on so heavily by the public. Engineers build the structures and machines that people must be able to trust. Engineering codes also emphasize the importance of transparency in ones’ work and calculation and the importance of professional development (both for oneself and in helping others). Like scientists, they emphasize fair and accurate reporting of data and disclosing conflicts of interest. Engineering codes also bring up intellectual property concerns. Many of the current professional engineering codes are modeled after the Accreditation Board for Engineering and Technology’s Code of Ethics, which involves “Fundamental Principles,” “Fundamental Canons,” and “Suggested Guidelines for use with the Fundamental Canons of Ethics.” Interestingly, engineering codes tend to have more structured layers than scientific codes, as you can see if you compare the ABET Code of Ethics and associated documents versus the American Institute of Chemists Code of Ethics. In addition to these principles and canons, the ABET has published “Suggested Guidelines for Use with the Fundamental Canons of Ethics,” which explains each Canon in more specific detail.15 Running for about seven pages, each numbered canon gets several alphanumerical subpoints added below it – lettering ‘a’ through ‘o’ in explaining canon four about conflicts of interest and ‘a’ –through ‘p’ in explaining canon five on fairness. These engineers are very detailed.

14 15

Sarah Baxter, personal conversation, 24 March 2004. ABET Code of Ethics.

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The American Institute of Chemical Engineers (AIChE) has a code of ethics which every applicant to the group must sign. Though less than a page long, this code highlights safety, responsibility, truthfulness, avoiding conflicts of interest, fairness, competence, and professional development. The IEEE Code of Ethics for engineers features ten items, upholding values similar to the other engineering societies (though no environmental concerns). However, their most interesting commitment is their number five, which is not explicitly written in any of the other codes. It reads: “to improve the understanding of technology, its appropriate application, and potential consequences.”16 This IEEE point is one that might be very suitable for a nano-studies code. The codes of ethics for different societies differ as much as the foci of the societies do. Certainly, civil engineers, building outside, have to work around and work with the environment more than an electrical engineer would, so it makes sense that these societies would have differing foci when it comes to such things. The same goes for physicists and molecular biologists, as well as any other subdisciplines in science or engineering. Not all people within a profession know the codes of ethics associated with their discipline, but the values contained within the code are usually known.17 In speaking with different scientists and engineers, I found that everyone had the basic ideas about what their profession held as valuable in ethics and that they try to impart these values to their students. In further questioning about nanostudies, one scientist pointed out that nanotechnology and nanoscience are different from chemistry because of the hype factor; she said it is more crucial in nano-studies to stick to the reality of the lab and do more public outreach18 because there is more public concern due to the hype that nanotechnology has right now.19 One engineering professor pointed out that codes of ethics are useful, but not in the sense of legislating; they are useful in thinking about possible problems and bringing them out for discussion and consideration.20 Codes of ethics serve a role in the development of a profession and a professional identity. By identifying the core values associated with practice, nanotechnologists will be able to better identify themselves and their practice within a larger context.

7.4

Developing a Code of Ethics for Nanotechnology

Codes of ethics signal the seriousness of a group of professionals to think about their impacts and goals. The emergence of professional organizations and professional codes of ethics are an important part in the development of a discipline or 16

IEEE Code of Ethics. Interviews with scientists and engineers, March–April 2004. 18 She pointed to USC’s Citizen’s School of Nanotechnology as one example of beneficial public outreach. 19 Cathy Murphy, personal conversation, 18 March 2004. 20 Sarah Baxter, personal conversation, 24 March 2004. 17

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sub-discipline. They help provide a professional identity for a field of study. Nanotechnology, being so diverse and distinct because of its diversity, should be developed to address the aims of the many other disciplines it encompasses, but this coming together of disciplines also serves to make the formation or “professionalization” of this field more difficult and complex. How should this profession develop, and what values should it hold? What is its identity? What is the aim of this new field? In other words, what should its code of ethics be?

7.4.1

Aim of Nanotechnology

Since both scientists and engineers are receiving grants for nanotechnology, it seems only appropriate to incorporate both foci as being beneath the umbrella term ‘nanotechnology.’ ‘Nanotechnology’ is defined in different ways depending on where you look. Often you will see a distinction made between ‘nanoscience’ and ‘nanotechnology’ on the basis the goals of inquiry versus the making of something, but this division seems somewhat artificial because there is a high degree of multidisciplinarity in the field. This collaboration and diversity has been pushed by the agencies grounding the funding for nanotechnology.21 ‘Nanotechnology’ is not simply nanoengineering, nor is it nanoscience either. There is something that transcends the traditional division of the two fields going on. The pure/applied distinction normally considered between science and engineering continues to be destabilized with nanotechnology. Therefore, the use of the term ‘nanotechnology’ shall be regarded as an umbrella term for the investigation on or of the nanoscale, combining the aims of both fields. According to the National Nanotechnology Initiative—and note that this initiative is not the National Nanoscience Initiative—nanotechnology is set to create “the Next Industrial Revolution.”22 The NNI wants to “fuel innovation” by “improving fundamental understanding,” “focusing on applications,” using multidisciplinary collaboration, and encouraging “technology transfer” (National Science and Technology Council, 2003).23 Nanotechnology’s aims are about using basic science to work to advance technological endeavor. This close tie between basic scientific work and technological advancement is a new way of characterizing the work of scientists and engineers. The professions become closer by this emphasis and previous paradigms of work become molded together. The aims of nanotechnology set it apart from traditional constructions of science and engineering. John H. Marburger, III, of the Office of Science and Technology Policy wrote to Congress:

21

National Nanotechnology Initiative. NNI Budget by Agency. From the home page of their website: www.nano.gov, and from the NNI Supplement to the President’s FY 2004 Budget, and from other materials on the NNI. 23 For a further discussion, see Johnson (2004). 22

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Applications that draw on advances in the multiple disciplines, such as chemistry, physics, biology, and materials, are blurring the distinctions of traditional scientific domains and creating a new culture of interdisciplinary science and engineering. (National Science and Technology Council, 2003)

A new culture in nanotechnology is indicative of new aims. Scientists working in the field of nanotechnology are directed toward application and production. Engineers in nanotechnology are perhaps doing work already considered part of its construction, but the research can be more basic and the science less understood. Nanotechnology redirects the aims and goals of the contributing fields purposefully; the literature about nanotechnology funding put out by the NNI is clear about this. The European Union has also been funding nanotechnology. EurActiv (2005), a website dedicated to EU News and Policy explains: The technology stretches across the whole spectrum of science, touching medicine, physics, engineering and chemistry, and so is difficult to pin down to one discrete area… Research is expected to lead to advances in areas such as medicine, environment, manufacturing, communications and electronics… Described as ‘a new industrial revolution’, nanotechnologies have the potential to produce sweeping changes to all aspects of human society.

The US is not the only country caught up in the excitement of the possibilities for nanotechnology and its great aims. So far, nanotechnology’s aims have been encouraged and facilitated by funding, but its aims need to develop within the community of scientists and engineers who do the research. One way of discussing goals and values is to organize around the creation of a code of ethics.

7.4.2

A Code for Nanotechnology

Professionals working with the nanoscale need to be aware of the public’s perception when they make statements. The NBIC report, Drexler’s Engines of Creation, the NNI reports, and other documents that outline plans for the nanoscale have promised much. The NBIC Report, “Converging Technologies for Improving Human Performance,” tries to lay out the possibilities for human improvement with the advancing technologies associated with the convergence of nanotechnology, biotechnology, information technology, and cognitive science (Roco and Bainbridge, 2002). This reports talks about altering the “fabric” of society, initiating a “new renaissance,” and converging technologies being “a turning point in the evolution of human society” (Roco and Bainbridge, 2002). Eric Drexler’s well-written Engines of Creation easily moves from replication of DNA to molecular assemblers, tiny molecular machinery that can alter the structure of atoms, creating new and more desirable materials, literally turning trash into treasure (Drexler, 1986). The National Nanotechnology Initiative material is no less eager; at the beginning of one report, we are asked to:

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[i]magine a single area of scientific discovery with the potential to enable a wealth of innovative new technologies across a vast array of fields, including healthcare, information technology, energy production and utilization, homeland security and national defense, biotechnology, food and agriculture, aerospace, manufacturing, and environmental improvement. (National Science and Technology Council, 2003)

This hype for nanotechnology is dangerous in that the public’s expectancy for the technology may be too great or only in the short-term. This could hurt the funding of such science and technology, as well as the reputation of such studies. Starting a dialogue within a community that includes scientists, engineers, business people, and others would be a good start to reducing the hype factor and educating the public. The hype factor in nanotechnology is only detrimental in the long-run. Nanotechnology is currently very two-faced in that it mostly consists in research, but we are told that it is going to solve all of our problems in the very near future. With nanotechnology, having some common values to agree on and point to may prevent problems and misunderstanding in the future. Researchers into nanotechnology would be best served in having dialogue with one another about values so that there can be some sense of common ethical ground among colleagues. Writing a code of ethics for nanotechnology is both easier and harder than earlier professional codes. Codifying the ethics of nanotechnology will be easier because nanotechnology seems to be emerging from several already professionalized fields. Further, histories of nanotechnology have established nanotechnology’s guiding aims from Feynman’s “There’s Plenty of Room at the Bottom” lecture— whether or not researchers of nanotechnology actually knew of the document in the beginning (Feynman, 1959). Codifying the ethics of nanotechnology will be harder in the sense that there is still contention about how the field is defined and who is a nanotechnologist. However, there are some things that I think a code for nanotechnology should include, despite possible debates in the future. A code of ethics for nanotechnology needs to include a focus on honesty in the representation of data and results both in the public arena and within the community. Right now, the public is being to believe that nanotechnologists are working to create tiny robots, but this perception may lead to disappointment and disaster for nanotechnology as a field. Nanotechnologists need to know what the professional expectations are for their field, and they can work to have these defined by communicating with each other and the public. In nanotechnology, the public arena and engagement with the public are particularly important because of the newness and the hype of the field of nanotechnology. Scientists usually have to answer to other scientists, but, in this case, it might be beneficial to both the field and the public for a broader and more public dialogue on the nature of the field and on the duties of someone working in nanotechnology. Before any mention of honesty is proper in the code, nanotechnologists should first address public safety because of the fear factor associated with popular representations of nanotechnology in the media. Because of the aims toward application that we find in all the funding and founding documents of nanotechnology, the public will be receiving the outcomes.

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Suggested Code of Ethics for Nanotechnology

Discussion and debate are healthy and desirable in the development of a code of ethics (and the development of an understanding among colleagues). Codes should be carefully considered and amended to properly represent the values of the field. Practitioners in the field of nanotechnology need to be the ones creating the code. A code means very little if it is simply inherited without reflection on the issues and the values of the field. My code is meant to spark discussion and thought on values and professionalization and is not meant for immediate adoption. (Preamble) We, Nanotechnologists, realize our special position in science, engineering, and society. Nanotechnology’s specialness is a result of the hype and attention the field has received and the explicit discarding of the pure/applied distinction between science and engineering. Our aims and position require a broader understanding of ethics and of the repercussions involved in pursuing any phenomena or application. Nanotechnology has a purpose in discovering underlying atomic properties and their manipulation for practical application to benefit the welfare of people. To this end, we are mindful of the impacts of our work, seeking to investigate, to help others understand, and to apply scientific research towards positive application. Our commitment to professional ethics and practice includes: By starting with a preamble explaining why a code is necessary, nanotechnologists can have a common understanding of why the code is worthwhile. (Code of Ethics) 1. Holding paramount the welfare of the public: (a) By accepting responsibility in making decisions consistent with safety, health, and welfare of the public; and (b) By informing the proper officials and the public when there are risks to the public. The public needs to be recognized at the outset of the code because of all the public worry and hype about the field. By first stating in their code the importance of the welfare of the public, nanotechnologists recognize their responsibility to their fellow citizens of the world. 2. Engaging in public discourse on the subjects we study with public comments made on all matters of nanotechnology being made with care and precision: (a) By explaining without exaggeration; (b) By seeking public reaction and input; and (c) By admitting when not all the answers are known. Public discourse is important for nanotechnologists because of the hype I have discussed. (2b) is especially important. Nanotechnologists need not only to speak about nanotechnology to the public, but to seek out reaction from the public. Nanotechnologists need to be aware of and sensitive to the perceptions and beliefs that are out there concerning nanotechnology.

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3. Promoting truth and exposing error, being transparent in calculation, representation and purpose: (a) By remaining current on topics in the field; (b) By sharing ideas and information with colleagues and co-workers; (c) By maintaining complete and accurate scientific records; (d) By accurately depicting the phenomena and not intentionally using misleading material; (e) By pursuing truth and goodness; (f) By following proper practices for publishing and presenting research; (g) By giving due credit to contributors and sources; and (h) By seeking, accepting, and offering honest criticism. This principle is a rather broad one, but it will speak to scientists about their role in nanotechnology. Because of the funding associated with nanotechnology, it is important for nanotechnologists to remember the values of the professions from which they came. With nanotechnology, scientists and engineers still need to be aware of the responsibilities they still have. (3d) is especially important here because of the images used in nanotechnology; the public (myself included) cannot tell what is real and what is imagined in these images. Nanotechnologists need to be particularly aware of how they depict the phenomena with which they deal and the plans they have for the future. 4. Improving the understanding of technology, its aims, and its repercussions: (a) By imagining the possible outcomes and applications of the research; (b) By looking to the societal implications; and (c) By seeking input from all classes of society. This particular principle is taken from the IEEE Code of Ethics. It is unique to that particular code, as far as I can tell, and it is a very good principle for a community that deals with high technology. (4b) and (4c)—and I added the parts—are really important to addressing the hype associated with nanotechnology. Once again, this codes points nanotechnologists toward the public in order to seek input from all groups of society. 5. Avoiding conflicts of interest, real or perceived: (a) By disclosing any possible conflicts of interest when they exist; (b) By rejecting bribery of any sort; and (c) By entering only into agreements and contracts with openness. This principle we see in some variety in most scientific and engineering codes of ethics. It is important to reemphasize this principle for novices in the field and as a reminder for more seasoned practitioners. 6. Keeping private any proprietary information gained in work when the confidentiality is consistent with public interest and the law. This was taken from the Software Engineering Code of Ethics Section 2.05. The idea of this principle is something typically seen in engineering codes of ethics,

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but some scientists also need to be aware of the new responsibilities they might face, especially when working with engineers who may be under confidentiality agreements or entering into confidentiality agreements through the funding they receive. 7. Acting fairly the treatment of others: (a) By not acting in a discriminatory manner; (b) By working to encourage novices and trainees in the field; (c) By treating subordinates with respect; (d) By helping colleagues to develop professionally and supporting them in related matters; (e) By not engaging into unfair competition with others; and (f) By seeking diversity in the scientific community. We see statements of fairness in both scientific and engineering codes of ethics, but (7f) was added—and suggested to me by Ann Johnson—due to nanotechnology’s hyped status. By seeking diversity in the community of science, concerns that reflect society are more likely to be voiced early in development of the technologies that nanotechnology promises. By adding (7f), I was thinking specifically of nuclear technology. Nuclear power facilities are seen as very undesirable by its neighbors. People would rather live near coal-burning power plants than nuclear ones, despite the fact that coal-burning plants are often much more harmful to the health of the people living around them because public perception of nuclear technology is so negative. Also, when undesirable technologies are located, they hurt the lowest income brackets. By having input from various backgrounds, nanotechnologists can work to ensure a solid future. These things we pledge as nanotechnologists, for the welfare of the public, for the advancement of truth and society, and for our professional wellbeing. The restatement of aims is a nice way to end a code; this is an aesthetic consideration. The primary values that should be emphasized in a code of ethics for nanotechnology are public good, honesty, and transparency, so these are the top things that are discussed in the code. I have looked at many codes of ethics in the course of working on this paper, but the three codes I have relied on the most to write my code are the IEEE Code of Ethics, the Chemist’s Code, and the ABET Code of Ethics. These codes were looked at for their diversity of style, thought, and wording. The IEEE also had one unique principle that is reflected in my (4).

7.5

Conclusion

In thinking about nanotechnology, the analogous historical situation of science which first comes to mind is the building of the atomic bomb with the Manhattan Project. Science was explicitly directed to application in the case of nucleonics, in a way that we see now in nanotechnology. The development of the atomic bomb involved many players, like nanotechnology, and more than one nation. The atomic

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bomb would also have great consequences for those who had no say in its development. Physicists who worked on the Manhattan Project have not gone without reflection on the societal concerns raised by their work, but there was no look into the societal implications by those not directly linked to the project. Citizens of the world were given no voice in a decision that had consequences to them. Perhaps it is here that the analogy breaks down because nanotechnology involves many applications and the Manhattan Project involved only one. Further, the bomb was developed for warfare, where only some of nanotechnology’s applications are for military use. I think the analogy is still a good one; both sets of projects—Manhattan and nanotechnological—have (or have had) large consequences for the world and its citizens. Public discussion about nuclear technology came only after the bombs were dropped, though insiders prepared numerous reports on future implications, but nanotechnology’s public discussions can happen now, with nanotechnologists stepping up and confronting the hype the field faces and the reality of the applications their research may have. Current rhetoric has aimed scientists differently than they traditionally consider themselves. Scientists working in nanotechnology are working towards the production of something, and they need an awareness of their position. A new code of ethics for nanotechnology is the first step to adjusting to shifts of aim and directing professionals to the new concerns that the new aim brings.

References ABET. 2004. Accredited Engineering Programs, August. http://www.abet.org/accredited_ programs/engineering/schoolarea.asp. Cited 9 January 2005. Amato, I. 2004. Nano’s Safety Checkup. Technology Review. Australian Computer Society Media Release. 2004. Peak Bodes Adopt International Code of Ethics and Practice in Software Engineering, April. http://www.acs.org.au/news/060404.htm. Cited 6 December 2004. Baird, D. and A. Shew. 2004. Probing the History of Scanning Tunneling Microscopy. In Discovering the Nanoscale, eds. D. Baird, A.Nordmann, and J. Schummer, 145–156. Amsterdam: IOS Press. Baird, D. and A. Shew. 2004. The Mythology of Nanotechnology. Unpublished manuscript. Beauchamp, T.L. and J.F. Childress. 1994. Principles of Biomedical Ethics. Oxford: Oxford University Press. Bullough, V et al. eds. 1990. Florence Nightingale and Her Era: A Collection of New Scholarship. New York: Garland Publishing, Inc. Dennis, K.E. and P.A. Prescott. 1985. Florence Nightingale: Yesterday, today, and tomorrow. Advances in Nursing Science 7.2 (January): 66–81. Dossey, B.M et al. 2005. Florence Nightingale Today: Healing, Leadership, Global Action. Silverspring, MD: American Nurses Association. Drexler, E. 1986. Engines of Creation: The Coming Era of Nanotechnology. New York: Anchor Books. EurActiv. What is Nanotechnology? Nanotechnology Policy Section, 13 January 2005. http:// www.euractiv.com/Article?tcmuri=tcm:29-117523-16&type=LinksDossier. Cited 18 February 2005.

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Feynman, R.P. 1959. There’s Plenty of Room at the Bottom. Speech at the American Physical Society Meeting at Caltech. http://www.zyvex.com/nanotech/feynman.html. Cited 10 February 2005. Fitzpatrick, M.L. 1983. Prologue to Professionalism: a History of Nursing. Bowie, MD: Prentice-Hall. Ford, G. and N.E. Gibbs. 1996. A Mature Profession of Software Engineering. Pittsburgh: Carnegie Mellon University, sponsored by the Department of Defense. Fry, S.T. 1989. The Role of Caring in a Theory of Nursing Ethics. Hypatia 4.2: 88–103. Fry, S.T. 2004. Nursing Ethics. In Handbook of Bioethics: Taking Stock of the Field From Philosophical Perspective, ed. George Khushf, 489–506. Dordrecht: Kluwer Academic. Gotterbarn, D et al. 1999. Software Engineering Code of Ethics is Approved. Communications of the ACM 42.10 (October): 102. Hirshler, B. 2004. Nanotechnology may pose mega health risks. IOL. http://www.itechnology. co.za/general/news/newsprint.php. Cited 20 January 2004. IEEE Computer Society. 2004. History of the Joint IEEE Computer Society and ACM Steering Committee for the Establishment of Software Engineering as a Profession. http://www. computer.org/tab/seprof/history.htm. Cited 6 December 2004. Johnson, A. 2004. The End of Pure Science: Science Policy from Bayh-Dole to the NNI. In Discovering the Nanoscale, eds. Davis Baird, Alfred Nordmann, and Joachim Schummer, 217–230. Amsterdam: IOS Press. Kuo, F. 1969. Let’s make our best people into software engineers and not computer scientists. Computer Decisions 1.2 (November): 94. McClure, R. 2001. Introduction. NATO Software Engineering Conferences, July 2001. http:// homepages.cs.ncl.ac.uk/brian.randell/NATO/Introduction.html. Cited 6 February 2005. National Nanotechnology Initiative. NNI Budget by Agency. http://www.nano.gov/html/ about/ nnibudget.html. Cited 10 March 2005. National Science and Technology Council. 2003. National Nanotechnology Initiative: Research and Development Supporting the Next Industrial Revolution. Supplement to the President’s FY 2004 Budget. Roco, MC. and W.S. Bainbridge, eds. 2002. Converging Technologies for Improving Human Performance. NSF/DOC-Sponsored Report (June 2002). Task Force on Body of SE Knowledge. 1997. Report on Analyses of Pilot Software Engineer Survey Data, March. http://www.computer.org/tab/seprof/survey.htm. Cited 6 December 2004. Task Force on Body of SE Knowledge. 1997. Report on Analyses of Pilot Software Engineer Survey Data, March. http://www.computer.org/seprof/part5.htm. Cited 6 December 2004. Toumey, C. 2005. Apostolic Succession. Engineering & Science 1–2: 16–23. Vicinus, M. and B. Nergaard, eds. 1990. Ever Yours, Florence Nightingale. Cambridge, MA: Harvard University Press. Weiss, R. 2004. For Science, Nanotech Poses Big Unknowns. Washington Post (1 February 2004): A16.

Chapter 8

The Tangled Web of Tiny Things: Privacy Implications of Nano-electronics Jeroen van den Hoven

8.1

Introduction

“The Internet of Things” refers to the steadily growing network of intelligent sensors, near field communication devices and RFID tags. The International Telecommunication Union defines it as follows: “The Internet of Things is a technological revolution that represents the future of computing…and its development depends on…innovation in a number of different fields, from wireless sensors to nanotechnology.”1 Directly and indirectly these sensors and tags produce and process an incredible amount of information about the location and properties of objects, and indirectly about people who can somehow be associated with them, because they carry them, are near to them, or are registered as their owners. The qualifications “ubiquitous”, “pervasive”, “ambient” and “speckled” in the expressions “ubiquitous computing”, “pervasive computing”, “ambient intelligence” and “speckled computing” need to be taken very serious indeed.2 We are in the process of crowding our life-world with very small, smart and interlinked sensors. The core technology which drives this development is sub-micron and nano-electronics. The development of ever smaller integrated circuits at the sub-micron and nano-scale–in accordance with Moore’s Law, which states that the number of transistors on a chip doubles every 18 months—drives the production of very small tags, smart cards, smart labels and sensors. It supports a generation of surveillance technology which is practically invisible. One of the problems with nano-ethics is that it is concerned with problems of future and speculative applications of nano-science. In the first decade of the twenty-first century we still have very few examples of widely used nano-technology. It is difficult to start a process of reflection on the social and ethical implications of new technology at the early stages of its development. This predicament is a version of the Collingridge dilemma: in the first stages of the development of a new technology 1

ITU Report, 2005, The Internet of Things, Executive Summary, 4. See http://www.specknet.org: “Specks will be minute (around 1 mm3) semiconductor grains that can sense and compute locally and communicate wirelessly. Each speck will be autonomous, with its own captive, renewable energy source. Thousands of specks, scattered or sprayed on the person or surfaces, will collaborate as programmable computational networks called Specnets.” 2

F. Allhoff, P. Lin (eds.) Nanotechnology & Society: Current and Emerging Ethical Issues, © Springer Science + Business Media B.V. 2008

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it is still possible to influence the development of the technology, although there is little information about its effects. When the technology is entrenched and widely used, information about its effects is available, but there is little room to change the course of the development of the technology. One of the areas where we have already a relatively clear picture of the impact of nanotechnology at this stage is the area of the privacy implications of submicron and nano-electronics. This is an area where we can move beyond mere speculation and science fiction. Practically invisible badges, tiny tags, minute sensors or “smart dust” and wearable electronics are being developed and produced and are gradually finding their way to the world of retail, supply chains, defense, agriculture, logistics, shops and warehouses, workplace, criminal justice and homeland security. When new sensors and surveillance devices are combined with middle-ware and back-end databases, as well as a range of wireless and mobile communication modalities, such as Wifi, Ultra Wide Band and Bluetooth, and connections to computer networks and the internet, the technology will give rise to a panoply of privacy issues. People will knowingly or unknowingly carry around everyday objects which are tagged (ranging from clothing to watches, mobile phones, chip cards, identity documents, bank notes, or jewelry). The tags can all be read and uniquely identified from a distance (ranging from centimeters to hundreds of meters) by readers which may be hidden or not in the line of sight. This will make objects, and the people carrying or accompanying them, traceable. They may be followed from shelf to shelf or from shop to shop and identified as the buyer, carrier, or user of an item, which can lead to further identifications and knowledge discovery in the associated databases.

8.2

RFID

The core technology of this type of tracking and tracing is the widely used Radio Frequency Identity Chip (RFID). An RFID chip or tag consists of a small integrated circuit attached to a tiny radio antenna, which can receive and transmit a radio signal. The storage capacity of the chip can now be up to 128 bits. The chip can either supply its own energy (active tag) from a battery or get its energy input from a radio signal from the antenna of the reader (passive tag). Like in the case of bar codes there is an international number organization which provides and registers the unique ID numbers of RFID chips.3 RFID technology is ideally suited for the tracking and tracing of objects such as boxes, containers and vehicles in logistics and supply chain management. Governments and the global business world are preparing for a large scale implementation of RFID technology in the first decades of the twenty-first century for these purposes.

3

EPCglobal, www.epcglobalinc.org, Cited 1 June 2007.

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Apart from a race to the bottom, which is made possible as a result of nanoelectronics, and the aim of making RFIDs smaller, one of the research challenges is to make the chips self-sufficient and energy saving, or even energy “scavenging”, in which case they will get energy from their environment in the form of heat, light or movement. The other challenge is to make them cheaper. One way to lower the unit cost of RFID chips is to find mass applications such as inserting chips into bank notes, which the EU is considering.4 With RFID each object has its own unique identifier and individuals will—apart from being walking repositories of biometric data—also show up in databases as clouds of tagged objects and become entangled in an “internet of things.”5 Combined with new internet protocols (e.g. IPv6, which supports assignment of so much more unique IP addresses for) RFID foreshadows what nano-electronics has in store for our privacy: invisible surveillance. RFID chips are also referred to as a “contactless technology”, “contactless chips”, or “proximity chips”. Many authors on RFID have signaled that there are privacy threats associated with the introduction of millions or even billions of smart tags and labels and RFIDs, in health-care, retail, travel, and law enforcement. As a result of opposition and critique of consumer organizations such as NOTAGS and CASPIAN RFID has received serious negative moral connotations.6 Benetton planned to put RFIDs in all of their clothing with the help of Philips. This gave rise to vehement consumer protest and tainted the reputation of Benetton and Philips. Tesco in the UK experimented with a photo camera in the store which was activated when consumers took a packet of Gillette razors of the shelf. The picture taken was then added to a consumer data base. This also gave rise to intense public debate, for understandable reasons. The Metro supermarket group in Germany has been the object of consumer protest when their plans to introduce RFID technology in their stores were made public. Commercial firms also experiment with terms which are not yet tainted with negative connotations. Both corporate world and governments fear that the many advantages to be had from RFID technology in health care, safety, security and industry may go unnoticed because of bad publicity and bad reputation of a few relatively frivolous first applications. The following examples give further evidence of a development towards tracking and tracing, monitoring and surveillance: ●

4

Precise real-time location systems using radio frequency identification tags have gone commercial.7 They use Ultra Wide Band communication to help locate tagged persons and objects in buildings with a precision of 30 cm. Several hospitals around the world monitor the location and movement of equipment and persons in the hospital with the help of RFID.

Yoshida, Euro bank notes to embed RFID Chips by 2005, EETimes 19 December 2001, http:// www.eetimes.com/story/OEG20011219S0016, Cited 1 June 2007. 5 This is the title of a study of the International Telecom Union, www.itu.int/internetofthings, Cited 1 June 2007. 6 Notags, http://www.notags.co.uk, Cited 1 June 2007; CASPIAN, Consumers Against Supermarket Privacy Invasion and Numbering, http://www.nocards.org, Cited 1 June 2007. 7 See Ubisense.net, http://www.ubisense.net, Cited 14 July 2007.

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The US Department of Agriculture conducts experiments with smart dust and nano-sensors which register properties of the environment and may help to detect the use of forbidden chemicals. The project is called “little brother”. CLENS is a strategic US defense initiative and stands for Camouflaged Long Endurance Nano Sensors,8 which allow precise location and tracking of soldiers during missions. Kris Pister’s group in California has many fascinating MEMS (Micro Electronic Mechanical Systems) applications on display, e.g. microphones 500 micrometer and research on cameras of 1 mm3. Extreme miniaturization in sensor technology and location-based services is clearly well underway.9 Kodak has patented digestible RFID tags.10 These can be attached to pharmaceutical products. This would enable prisons and psychiatric institutions, and hospitals to track medicine on the item level, even inside the human body. Especially in criminal justice contexts this would enable compliance management of prescribed medication.

Not only objects and artifacts may be tagged on the item level, also living creatures, animals and human beings may be tagged. The Food and Drug Administration has given final approval in 2004 to Applied Digital Solutions to sell their VeriChip RFID tags for implantation into patients in hospitals. The company Applied Digital Solutions introduces the Verichip for subcutaneous implantation in humans and there are more examples:11 ●

●

●

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Japan school children are chipped subcutaneous and are traced by a computer at school on their to and from school; The Baya Beach club in Rotterdam and Barcelona offers people the possibility of having a chip for payments in the club to be placed under their skin by a doctor who is present in the club; 160 people at the Ministry of Justice in Mexico received a chip under their skin to make it easier top trace them in case of kidnapping; and Millions of pets are chipped in the USA to make it easier to find them when they run away.

The US Federal government has recently experimented with RFID cards in immigration documents for foreign visitors in the context of the US Visit program, but the CEO of the company Digital Applications has taken this idea one step further: The CEO stated on National Television that the chip could be used to tag immigrants and monitor their movements.12 8 DefenseTech.org, Mini-sensors for “Military Omniscience,” http://www.defensetech.org/archives/ 002275.html, Cited 1 June 2007. 9 See the project Smart Dust: Autonomous Sensing and Communication in a Cubic Millimeter, http://robotics.eecs.berkeley.edu/~pister/SmartDust/, Cited 1 June 2007. 10 Beth Bacheldor, “Kodak’s RFID Moment,” RFID Journal (28 February 2007): http://www. rfidjournal.com/article/view/3100/, Cited 1 June 2007. 11 See for these examples Weinberg (2005). 12 Antichips.com, http://www.antichips.com/is-the-threat-real.htm, Cited 14 July 2007.

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Privacy Fears and Data-protection Problems

The sports kit of Nike running shoes and Apple’s iPod which registers details about your jogging was recently shown to present a privacy problem, since others could pick up the signal sent by your sneakers to your iPod and potentially identify you from a distance of 60 ft.13 The American Express Blue Card has an RFID chip in it which may beam back information about the cardholder. American Express has filed a patent under the description “Method and System for Facilitating a Shopping Experience”. It describes a Minority Report-style blueprint for monitoring consumers through RFID-enabled objects, like the American Express Blue Card.14 How can we know whether our new credit card from the credit card company comes with an RFID tag inside? What exactly are the privacy and data-protection problems of these practical applications of nano-electronics? The short answer is that we may become entangled in a web of tiny, smart things. SUN’s CEO, Scott McNealy, quipped “you have zero privacy anyway, so get over it”; under these circumstances, it might become the best advice. It may also lead to a “reversal of defaults” in that what was private becomes public, what was hard to copy is easy to duplicate, and what was easily forgotten can now be stored forever. On top of all these default reversals, may also come the reversal of the default or presumption of innocence. In the context of national security we may start to look at each other with a default of suspicion and scrutiny. A report on the legal issues of RFID of the EU15 identifies the following problems: First and obviously RFID tags may be related to personal information for example through constant or incidental association with unique (biometric) identifiers, such as credit cards at point of sale and identity cards with RFID tags. Since RFID tags can be read covertly, anyone with a reader or access to the stored information about patterns or tracks may get access to personal data without the consumers informed consent. RFID may be used for law enforcement and may lead to the rapid advancement of extensive policing and enforcement practices. People may have no choice to enter a digital realm, since their belongings will automatically register them. The technology may also lead to a situation where use of RFID tagged objects—of whatever sort—are necessary to take part in normal social life. Erik Spiekermann (Spiekermann & Ziekow, 2006) lists the following problems: unauthorized assessment of one’s belongings by others; tracking of persons via their objects; retrieving social networks; and technology paternalism, making people responsible for their objects. Langheinrich and Juels concur with these threats to the personal sphere.

13

Tom Espiner, Nike + iPod raises RFID privacy concerns, 13 December 2006, http://news.com. com/NikeiPod + raises + RFID + privacy + concerns/2100–1029_3–6143606.html, Cited 1 June 2006. 14 Katherine Albrecht and Liz McIntyre, “American Express Address RFID People Tracking Plans,” 09 March 2007, http://www.unobserver.com/layout5.php?id = 3265&blz = 1, Cited 1 June 2007. 15 Legal Issues for the Advancement of Information Society Technologies, “Legal Issues of RFID technology,” Document D15 IST 2–004252-SSA.

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Privacy is one of the major moral issues that is discussed in connection with the development and applications of nano-technology (Gutierrez, 2004; Mehta, 2003). In this section I present a framework for structuring debates on privacy in the context of nano-technology. This framework provides a taxonomy of moral reasons for dataprotection. It also provides us with suggestions for what has been referred to as “Value Sensitive Design” of technology, i.e. RFID- and nano-surveillance technology.16 Laws and regulations to protect the personal sphere and the privacy of persons have been formulated and implemented in the last 100 years around the world, but not without debate and controversy. A good deal of practical and legal consensus has emerged. Data protection laws and regulations define constraints on the processing of personal information, which function as de facto norms. These norms were already articulated in the OECD principles for data protection of 1984. The main principle—familiar in medicine and medical ethics—the principle of informed consent, forms the moral core of the European data protection laws (1995) and has started to influence thinking about privacy in the rest of the world. It states that before personal data can be processed, informed consent of the data subject is required: the person has to be notified; he must be offered the opportunity to correct the data if they are wrong; the use is limited to the purpose for which the data were collected; those who process data must guarantee accuracy, integrity and security and are accountable for doing so and are accountable for acting in compliance with the requirements of data protection laws. The requirements of security17 and accuracy are problematic in the case of RFID, since radio signals can, in principle, be sent and read by anyone. Even if individuals are aware of the tracking and tracing of objects and people as described above, there still would be problems with the technology from a data protection point of view: there could be cases of “sniffing, skimming and spoofing” when unauthorized readers are trying to get hold of the information stored on RFID’s in one’s possession.18 A low cost spoofing and cloning attack has been demonstrated on some RFID tags used for transport road tolling and the purchase of fuel at petrol stations. The researchers created a cheap code cracking device for a brute force attack on the 40-bit cryptographic key space on the tag.19 Why should we have such a stringent regime for data protection at the level of the principles of the OECD and the EU Directive of 1995? Why make the requirement of informed consent by individuals a necessary condition for the processing of their information? This often not spelled out, in full detail, but if

16

For references and literature, see Value Sensitive Design Research Lab, http://projects.ischool. washington.edu/vsd, Cited 1 June 2007. 17 See Spiekermann (2006) for a threat analysis. 18 A group at Johns Hopkins demonstrated that the minimal crypto on RFID chips can be cracked. 19 A group from the free university of Amsterdam lead by Andy Tanenbaum has shown that RFID’s can be infected by viruses that can spread via middle ware into databases and propagate See their “Is Your Cat Infected with a Computer Virus?,” http://www.rfidvirus.org/papers/ percom.06.pdf, Cited 1 June 2007.

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privacy and data protection are important it is important to know exactly why they are important. Privacy has been the subject of much philosophical discussion (Nissenbaum, 2004; Roessler 2005; DeCew, 1997, Van den Hoven, 2005) and different authors have presented different accounts of privacy. Although there are many different accounts, I think the following taxonomy of moral reasons is useful for justifying the protection of personal information and constraints on the design and use of a new generation of nano-surveillance devices. The taxonomy has the advantage of turning the privacy discussion into a more or less tractable problem of “data protection”. In this way the problems can be stripped of their emotional connotations and solid reasons for engaging in data protection can be proposed. The following moral reasons can account for the importance given to individual control over personal data: prevention of information-based harm; prevention of informational inequalities; prevention of informational injustice and discrimination; and respect for moral autonomy and identity. In claiming privacy we do not simply and nondescriptly want to be “left alone” or to be “private”, but more concretely we want to prevent others from harming us, wronging us by making use of knowledge about us, or we want fair treatment, equality of opportunity and do not want to be discriminated against.

8.4 8.4.1

Moral Reasons for Data-protection Information-based Harm

The first type of moral reason for data-protection is concerned with the prevention of harm, more specifically harm that is done to persons by making use of personal information about them. Criminals are known to have used databases and the Internet to get information on their victims in order to prepare and stage their crimes. The most important moral problem with “identity theft” for example is the risk of financial and physical damages. One’s bank account may get plundered and one’s credit reports may be irreversible tainted so as to exclude one from future financial benefits and services. Stalkers and rapists have used the Internet and on-line databases to track down their victims. They could not have done what they did without tapping into these resources. In an information society there is a new vulnerability to information-based harm. The prevention of information-based harm provides government with the strongest possible justification for limiting the freedom of individual citizens. RFID information could be sniffed, people could be monitored, accurate pictures could be made of what they carry with them and their identity could be stolen. We would also like to prevent that people deceive others by manipulating the information about the nature of objects and present goods as new, when they are old, as edible when they are in fact poisonous, as legitimate when they are stolen, as having cleared customs, when they were in fact smuggled.

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No other moral principle than John Stuart Mill’s “Harm Principle”20 is needed to justify limitations of the freedom of persons who cause, threaten to cause, or are likely to cause, information-based harms to people. Protecting personal information, instead of leaving it in the open, diminishes the likelihood that people will come to harm, analogous to the way in which restricting the access to fire arms diminishes the likelihood that people will get shot in the street. We know that if we do not establish a legal regime that somehow constrains citizens’ access to weapons, the likelihood that innocent people will get shot increases.

8.4.2

Informational Equality

The second type of moral reason to justify data-protection is concerned with equality and fairness. More and more people are keenly aware of the benefits that a market for personal data can provide. If a consumer buys coffee at the shopping mall, information about that transaction can be generated and stored. Many consumers have come to realize that every time they come to the counter to buy something, they can also sell something, namely, information about their purchase or transaction (transactional data). Likewise, sharing information about ourselves—on the Internet with web sites, or through sensor technology—may pay off in terms of more and more adequate information (or discounts and convenience) later. Many privacy concerns have been and will be resolved in quid pro quo practices and private contracts about the use and secondary use of personal data. RFID sensor, tracing and tracing would turns our environment into a transaction space, where information is generated constantly and systematically. But although a market mechanism for trading personal data seems to be kicking in on a global scale, not all individual consumers are aware of this economic opportunity, and if they do, they are not always trading their data in a transparent and fair market environment. Moreover they do not always know what the implications are of what they are consenting to when they sign a contract or agree to be monitored. We simply cannot assume that the conditions of the developing market for personal data guarantee fair transactions by independent standards. Data protection laws can help to guarantee equality and a fair market for personal data. Data-protection laws in these types of cases protect individual citizens by requiring openness, transparency, participation and notification on the part of business firms and direct marketers to secure fair contracts. Amazon was already accused of price targeting.21 In general, if a retailer knows that I like product X and bought lots of it, irrespective of its price, then they may 20

John Stuart Mill, On Liberty (Penguin Books: London, 1977), 68: “…the only purpose for which power can be rightfully excercised over any member of a civilized community, against his will, is to prevent harm to others.” 21 See Paul Krugman, “What Price Fairness, http://www2.sims.berkeley.edu/courses/is231/f02/ amazon_pricing.pdf, Cited 1 June 2007.

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charge me more for X than someone who does not know the product and needs to be enticed by means of low prices and discounts.

8.4.3

Informational Injustice

A third and important moral reason to justify the protection of personal data is concerned with justice in a sense which is associated with the work of the political philosopher Michael Walzer (Walzer, 1983). Michael Walzer has objected to the simplicity of John Rawls’ conception of primary goods and universal rules of distributive justice (Rawls, 1971)22 by pointing out that “there is no set of basic goods across all moral and material worlds, or they would have to be so abstract that they would be of little use in thinking about particular distributions”. Goods have no natural meaning, their meaning is the result of socio-cultural construction and interpretation. In order to determine what is a just distribution of the good we have to determine what it means to those for whom it is a good. In the medical, the political, the commercial sphere, there are different goods (medical treatment, political office, money) which are allocated by means of different allocation or distributive practices: medical treatment on the basis of need, political office on the basis of desert and money on the basis of free exchange. What ought to be prevented, and often is prevented as a matter of fact, is dominance of particular goods. Walzer calls a good dominant if the individuals that have it, because they have it, can command a wide range of other goods. A monopoly is a way of controlling certain social goods in order to exploit their dominance. In that case advantages in one sphere can be converted as a matter of course to advantages in other spheres. This happens when money (commercial sphere) could buy you a vote (political sphere) and would give you preferential treatment in healthcare (medical), would get you a university degree (educational), etc. We resist the dominance of money—and other social goods for that matter (e.g., property, physical strength)—and think that political arrangements allowing for it are unjust. No social good X should be distributed to men and women who possess some other good Y merely because they possess Y and without regard to the meaning of X. What is especially offensive to our sense of justice, Walzer argues, is: first, the allocation of goods internal to sphere A on the basis of the distributive logic or the allocation scheme associated with sphere B; second, the transfer of goods across the boundaries of separate spheres; and third, the dominance and tyranny of some goods over others. In order to prevent this, the “art of separation” of spheres has to be practiced and “blocked exchanges” between them have to be put in place. If the art of separation is effectively practiced and the autonomy of the spheres of justice is guaranteed then “complex equality” is established. One’s status in terms of the

22

John Rawls, A Theory of Justice (Cambridge, MA: Harvard University Press, 1971).

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holdings and properties in one sphere are, ceteris paribus, irrelevant to the distribution of the goods internal to another sphere. Walzer’s analysis also applies to information (Van den Hoven, 1998). The meaning and value of information is local, and allocation schemes and local practices that distribute access to information should accommodate local meaning and should therefore be associated with specific spheres. Many people do not object to the use of their personal medical data for medical purposes, whether these are directly related to their own personal health affairs, to those of their family, perhaps even to their community or the world population at large, as long as they can be absolutely certain that the only use that is made of it is to cure people from diseases. They do object, however, to their medical data being used to disadvantage them socioeconomically, to discriminate against them in the workplace, refuse them commercial services, deny them social benefits, or turn them down for mortgages or political office on the basis of their medical records. They do not mind if their library search data are used to provide them or others with better library services, but they do mind if these data are used to criticize their tastes, and character.23 They would also object to these informational cross-contaminations when they would benefit from them, as when the librarian would advise them a book on low-fat meals on the basis of knowledge of their medical record and cholesterol values, or a doctor poses questions, on the basis of the information that one has borrowed a book from the public library about AIDS. We may thus distinguish another form of informational wrongdoing: “informational injustice”, that is, disrespect for the boundaries of what we may refer to, following Michael Walzer, as “spheres of justice” or “spheres of access”. I think that what is often seen as a violation of privacy is often more adequately construed as the morally inappropriate transfer of data across the boundaries of what we intuitively think of as separate “spheres of justice” or “spheres of access.” RFIDs, and tagging and surveillance technology more generally, allow for a wide range of cross-domain profiling and information processing practices, which do not respect the boundaries of these spheres of access unless they are explicitly designed to do so. What was taken out of the public library is carried into a shop, what was taken from the pharmacist mat travel with you to the workplace. What was collected at the post office may accompany you to school, etc. We would certainly like border controls for RFID tagged objects and in some cases blocked exchanges between certain areas of our lives.

8.4.4

Respect for Moral Autonomy and Identity

Some philosophical theories of privacy account for its importance in terms of moral autonomy (see Van den Hoven, 1998, 2005)—i.e. the capacity to shape our own 23

The world of books and libraries is one of the most likely candidates for complete item level tagging RFID.

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moral biographies, to reflect on our moral careers, to evaluate and identify with our own moral choices, without the critical gaze and interference of others and a pressure to conform to the “normal” or socially desired identities. The beliefs of others, no matter how shaky their informational basis, can pre-empt acts and choices of selfdetermination and may thus compromise one’s status as a self-presenter. When individuals fail in this respect that is a source of shame.24 It reveals that one cannot manage the way one presents oneself. To be able to competently manage one’s identity is very important to modern contingent individuals, who have cast aside the ideas of historical and religious necessity, and who live in a highly volatile socio-economic environment, and a great diversity of audiences and settings before which they make their appearance. Being fixated in a moral identity by means of the judgments of others is felt as an obstacle to “experiments in living” as Mill called them25. The modern liberal individual wants to be able to determine himself morally or to undo his previous determinations, on the basis of more profuse experiences in life, or additional factual information. Data-protection laws provide the individual with the leeway to do just that. This conception of the person as being morally autonomous, as being the author and experimenter of his or her own moral career, provides a justification for protecting his personal data. Data-protection laws thus provide protection against the freezing of one’s moral identity by others than one’s self and convey to citizens that they are morally autonomous. A further explanation for the importance of respect for moral autonomy may be provided along the following lines. Factual knowledge of another person or another person is always knowledge by description. The person himself however, does not only know the facts of his biography, but is the only person who is acquainted with the associated thoughts, desires and aspirations. However detailed and elaborate our files and profiles on a person may be, we are never able to refer to the datasubject as he himself is able to do. We may only approximate his knowledge and self-understanding. Bernard Williams has pointed out that respecting a person involves “identification” in a very special sense, which could be referred to as “moral identification”: “…in professional relations and the world of work, a man operates, and his activities come up for criticism, under a variety of professional or technical titles, such as ‘miner’ or ‘agricultural labourer’ or ‘junior executive’. The technical or professional attitude is that which regards the man solely under that title, the human approach that which regards him as a man who has that title (among others), willingly, unwillingly, through lack of alternatives, with pride, etc….each man is owed an effort at identification: that he should not be regarded as the surface to which a certain label can be applied, but one should try to see the world (including the label) from his point of view.” (Van den Hoven, 1998)

24 See for this analysis J. David Velleman, “The Genesis of Shame,” in Self to Self (Cambridge: Cambridge University Press, 2006). 25 For a detailed account of the meaning and use of this expression, see Elizabeth Anderson, “John Stuart Mill and Experiments in Living,” Ethics 102 (1991): 4–26.

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Moral identification thus presupposes knowledge of the point of view of the data-subject and a concern with what it is for a person to live that life. Persons have aspirations, higher order evaluations and attitudes and they see the things they do in a certain light. Representation of this aspect of persons seems exactly what is missing when personal data are piled up in our data-bases and persons are represented in administrative procedures. The identifications made on the basis of our data fall short of respecting the individual person, because they will never match the identity as it is experienced by the data-subject. It fails because it does not conceive of the other on her terms. Respect for privacy of persons can thus be seen to have a distinctly epistemic dimension. It represents an acknowledgement of the fact that it is impossible to really know other persons as they know and experience themselves. Ubiquitous and pervasive computing with surveillance and monitoring as a permanent, but invisible feature may change our conception of ourselves as selfpresenters. Under such a technological regime the notion of “self-presentation” and the associated forms of autonomy, may disappear and become obsolete. The dominant view which is associated with the use of profiles and databases fails to morally identify individuals in Williams’ sense. Only if citizens can have a warranted belief that those who process their data adopt a moral stance towards them and are genuinely concerned with moral identification next to other forms of identification, can a universal surveillance and an entanglement of individuals in “an internet of things” be construed as morally acceptable.

8.5

Fundamental Privacy Problems with Nano-electronics: Invisibility

Privacy was construed above in terms of moral reasons for protecting personal information—i.e. moral reasons for putting constraints on the acquisition, processing and dissemination of personal information. The central constraint was informed consent; personal information can only be processed if the data-subject has provided informed consent. The moral reasons for making informed consent a necessary condition were discussed. This indicates that the core problem concerning privacy with nano-electronics is epistemic in nature. It is the fact that we do not know that we are monitored, tracked and traced. Stanley Benn (in Schoeman, 1984) already clearly stated what the problem with this epistemic condition is. We need to distinguish between two cases. First, if the information processing is covert, it is clear that this interferes with our autonomy, because our thinking and choices are tainted by our false assumption—i.e. that we assume we are unobserved. Many of our assumptions and reasoning can be defeated just by adding the information that we are observed. If the information processing is overt, we can adjust to being observed, but we no longer have the prior choice to be unobserved. In both ways our autonomy is compromised. A related but slightly different aspect of invisibility and lack of relevant knowledge was articulated by Jeffrey Reiman in his essay on Automated Vehicle

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Registration Systems (Reiman, 1997). If unbeknownst to me, my passage from A to B is registered, something strange happens. If asked what I did, I will respond that I drove from A to B. But this is only part of the story. My action could be more adequately described as “I drove from A to B and thereby created a record in the database of the system”. In the same way people will have to become aware of the fact that when they buy clothing they could be buying invisible transponders and memory sticks as well. It changes the conditions under which people consent to and intend things. Actions like trying on a coat, carrying a gift out of a shop, or driving from A to B, are no longer what they appear to be. What actually happens is that one buys a gift and one lets the store know which route one followed through the shop. A socio-technological system which obfuscates these mechanisms, robs individuals of chances to describe their actions more adequately. Moreover it seems to violate a requirement of publicity or transparency, articulated by Rawls and Williams among others. The functioning of social institutions should not depend on a wrong understanding of how they work by those who are subject to them. Suppose that ubiquitous and covert surveillance arrangements work well and to the satisfaction of a majority, then they seem to work because those affected by them have a false understanding of why and how they work. This seems to violate a reasonable requirement of transparency. A further fundamental problem needs to be discussed which is relevant to nanotechnology and ubiquitous surveillance by means of RFID and functionally equivalent technology. Is the information concerned personal information and does the data protection laws by implication apply? The answer is affirmative. Although an RFID tag may not contain personal information, although they sometimes do, if it is likely and not excessively expensive or cumbersome, that information can be linked in a back-end database so as to establish a match and add the data to a file which does contain data which can be linked to a natural person, it counts as personal data.

8.6

Value Sensitive Design

Professor of Security and Computer Science at Princeton Ed Felten has observed that “It seems that the decision to use contactless technology was made without fully understanding its consequences, relying on technical assurances from people who had products to sell. Now that the problems with that decision have become obvious, it’s late in the process and would be expensive and embarrassing to back out. In short, this looks like another flawed technology procurement program.”26

26

Michael Zimmer, “RFID Passports and the Need for Values in Design,” 14 April 2005, http:// michaelzimmer.blogspot.com/2005/04/rfid-passports-need-for-values-in.html, Cited 1 June 2007.

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Value Sensitive Design27 is a way of doing ethics that aims at making moral values part of technological design, research, development. It works with the assumption that human values, norms, our ethics for short, can be imparted to the things we make and use. It construes technology as a formidable force which can be used to make the world a better place, especially when we take the trouble of reflecting on its ethical aspects in advance. Information technology has become a constitutive technology, it partly constitutes the things to which it is applied. It shapes our practices and institutions in important ways. What health care, public administration, politics, education, science, transport and logistics will be within 20 years from now will be in important ways be determined by the ICT applications we decide to use in these domains. Nano-electronics will take privacy discussions to the level of the design of materials, surfaces, properties of artifacts and fabrics. This will require an adjustment in our thinking about legal and moral constraints on their development and use in addition to thinking about constraints on the use of the personal information they help to generate, store and distribute. Gildas Avoine and Philippe Oechslin have already argued that it is not sufficient to discuss data protection at the level of the application or at the level of the communication. They argue that also the physical level needs to be investigated (Avoine et al., 2004). For example, Juels, Spiekermann and Langheinrich, Moskowitz and Karjoth have started to think and work along the lines of Value Sensitive Design (although they do not refer to their work in these terms). The central question here is: how can we at an early stage of the development of the technology try to salvage the wonderful potential and possible social benefits of the functionality of RFID and nano-electronics, without having to suffer the drawbacks and potential dangers and data protection risk? Spiekermann provides a threat analysis and steps to counter the threats and Langheinrich provides design principles for RFID infrastructure and tags. There are various ways in which we could start to incorporate our values into our designs. A very good example is provided by IBM work on antennae of RFIDs. IBM has designed RFID labels that they can be easily torn of a label by consumers— the clipped tag—on a product, to limit the range in which they can be read. The tag has a couple of indentations; the more you tear of the more you limit the range in which the tag can be read. There are several ways in which the tags could be made visible, comparable to the way we notify people that they are on CCTV camera and the way we warn people that there are additives in food. In the same way we could notify people, empower them and give them means of controlling the flow of their information. The ideal of restoring a power balance regarding the use of one’s personal data is sometimes referred to as sousveillance. We can think about simple measures which create a Faraday cage (wrapping your passport in aluminum foil for example) by introducing ways in which sensors can be “killed”, or put in “privacy mode”, or signals are jammed, or tags get blocked by blocker tags. 27

Value Sensitive Design Research Lab, “Outreach,” http://www.ischool.washington.edu/vsd/ outreach.html, Cited 1 June 2007; Values in Design, “Homepage,” http://www.nyu.edu/projects/ valuesindesign/, Cited 1 June 2007.

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Costumers have good moral reasons to want to keep control over how they are perceived, in stores, in hospital and in the street, for moral reasons outlined above. They may fear harm, unfair treatment, discrimination, or they will start to feel unfree to be the person they want to be. This breach may be made explicit by means of the two ideas about privacy—data-protection or control over information, and constant observation.

8.7

Conclusion

Concerns about privacy and data protection in the context of nano-electronics will have to deal with design principles and design features of the tiny tags (both artifacts and infrastructure) that will soon add a new layer to our everyday life. Nano-technologists and designers of tags, sensors, and systems, material and fabrics and supply chain managers and retail people will have to think in terms of privacy by design in a stage of the development where it can still make a difference. They will have to worry about how existing nano-electronics can be made visible, optional, detectable, secure and in compliance with whatever principles we have good reasons to prefer in order to prevent us from being snared in a tangled web of tiny things.

References Antichips.com. http://www.antichips.com/is-the-threat-real.htm. Cited 14 July 2004. Avoine, G. and P. Oechslin. 2004. RFID Traceability: A multilayer Problem. http://lasecwww.epfl. ch/pub/lasec/doc/AO05b.pdf. Cited 1 June 2007 DeCew, J.W. 1997. In Pursuit of Privacy: Law, Ethics, and the Rise of Technology. Ithaca: Cornell University Press. EU Dataprotection laws. 1995. EU Directive95. http://europa.eu.int/comm/internal_market/ privacy/index_en.htm. Cited 1 June 2007. Garfinkel, S.L. and Ari Juels, R.P. 2005. RFID Privacy: An Overview of Problems and Proposed Solutions. IEEE Security and Privacy 3.3: 34–43. Gao, X et al. 2004. An Approach to Security and privacy of RFID System for Supply Chain. Proceedings of the IEEE International Conference on E-commerce Technology for Dynamic E-Business. doi: 10.1109/CEC-EAST.2004.14. Gutierrez, E. 2004. Privacy Implications of Nanotechnology, 26 April 2004. EPIC. http://www. epic.org/privacy/nano. Cited 28 June 2004. Juels, A. and S.A. Weis. 2006. Defining Strong Privacy for RFID. http://ieeexplore.ieee.org/xpl/ freeabs_all.jsp?arnumber = 4144854. Cited 1 June 2006. Juels, A. et al. 2005. High-Power Proxies for Enhancing RFID Privacy and Utility. http://www. rsasecurity.com/rsalabs/node.asp?id = 2948. Cited 1 June 2007. Juels, A. 2006. RFID Security and Privacy: A Research Survey. IEEE Journal on Selected Areas in Communications 24.2 (Feb): 381–394. Kardasiadou, Z. and Z. Talidou. 2006. Legal Issues of RFID Technology, LEGAL-IST. IST-2– 004252-SSA. D15. Langheinrich, M. 2004. Die Privatsphere im Ubiquitous Computing. http://www.vs.inf.ethz.ch/ res/papers/langhein2004rfid.pdf. Cited 14 June 2007.

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Masters, A. and K. Michael. 2006. Lend Me Your Arms: The Use and Implications of Humancentric RFID. Faculty of Informatics, University of Wollongong. http://ro.uow.edu.au/ infopapers/391. Cited 1 June 2007. Mehta, M.D. 2003. On Nano-Panopticism: A Sociological Perspective. http://chem4823.usask. ca/∼cassidyr/OnNano-Panopticism-ASociologicalPerspective.htm. Cited 1 June 2007. Molnar, D. and D. Wagner. 2004. Privacy and Security in Library RFID. Issues, Practices, and Architectures. www.cs.berkeley.edu/∼dmolnar/library.pdf. Cited 1 June 2007. Moskowitz, P.A. et al. 2006. Privacy-Enhancing Radio Frequency Identification Tag: Implementation of the Clipped Tag. RFID Journal Live (May 1–3). Nissenbaum, H. 2004. Privacy as Contextual Integrity. Washington Law Review 79: 101–139. Rawls, J. 1971. A Theory of Justice. Cambridge, MA: Cambridge University Press. Reiman, J. 1997. Driving to the Panopticon. In Critical Moral Liberalism, ed. J. Reiman, Lanham, MD: Rowman and Littlefield Publishers, pp. 169–188. Roessler, B. 2005. The Value of Privacy. Oxford: Polity Press. Schoeman, F.D. ed. 1984. Philosophical Dimensions of Privacy: An Anthology. Cambridge: Cambridge University Press. Spiekermann, S. and H. Ziekow. 2006. RFID: A Systematic Analysis of Privacy Threats & A 7 point Plan to Address them. Journal of Information System Security 1.3: 4–18. Ubisense.net. http://www.ubisense.net. Cited 14 July 2007. Van den Hoven, J. 1998. Privacy and the Varieties of Informational Wrongdoing. Australian Journal of Professional and Applied Ethics 1.1: 30–44. Van den Hoven, J. 2005. Privacy. In Encyclopedia of Science, Technology, and Ethics, eds. C. Mitcham, Detroit, MI: Macmillian Reference. Walzer, M. 1983. Spheres of Justice. Basic Books, New York. Wanczyk, S.D. 2004. The Nano-threats to Privacy: Sci-fi or Sci-fact? Culture, Communication & Technology Program, Georgetown University. Vol. 3, Spring. http://gnovis.georgetown.edu/ includes/ac.cfm?documentNum = 31. Cited 1 June 2007. Weinberg, J. 2005. RFID and Privacy. http://www.law.wayne.edu/weinberg/ rfid.paper.new.pdf.

Chapter 9

Carbon Nanotube Patent Thickets Drew L. Harris

9.1

Introduction

Carbon nanotubes are tiny structures made of “rolled-up” layers of interconnected carbon atoms. Due to their extraordinary properties, nanotubes could be used in a wide range of products across several industries. Their huge commercial potential has resulted in a frenzy to establish broad patent protection on nanotube inventions. As a result, anyone attempting to commercialize nanotube faces a dense “thicket” of patents and patent applications held by various firms, universities, and government labs. These carbon nanotube patent thickets are a vivid case study of the complicated and untested patent issues that face the nanotechnology industry as a whole. This essay explores the myriad issues posed by carbon nanotube patents. First, nanotubes and their potential commercial applications are briefly outlined. Next, the difficulty in navigating the nanotube patent thicket is presented through serious questions as to the validity and scope of some nanotube patent claims. Legal uncertainties are being raised in applying patent law doctrines— such as patentable subject matter, novelty, obviousness, and enablement—to challenge nanotube patent claims. For example, prior carbon fiber research from the 1970s and 1980s is being discovered that could potentially be used as invalidating prior art. Finally, the result of this uncertainty is described—frequent intra-industry and inter-industry patent disputes will impose substantial costs of firms seeking to commercialize nanotubes, and in some cases deter significant capital investments in nanotube-based products altogether. A potential solution is a “Nanotube Patent Forum,” which may serve as a means to facilitate cost-effective licensing transactions between patent holders and manufacturers.

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Commercial Potential of Carbon Nanotubes

Carbon nanotubes are classified as either “multi-walled” (with multiple hollow cylinders of carbon atoms nested inside one another) or “single-walled” (a single layer of carbon atoms and a hollow core).1 Both types of nanotubes are long and narrow, and both exhibit unique electrical, mechanical, thermal, and optical properties. For example, nanotubes can be lighter than aluminum and stronger than steel. Nanotubes have different electrical properties ranging from semiconducting to metallic depending on the “chiral” twist of the nanotube. Nanotubes have a current carrying capacity of 1 billion A/sq cm, while copper wires burn out at 1 million A/sq cm. It is estimated that nanotubes can transmit nearly twice as much heat as pure diamond, and are likely to remain stable in higher temperatures than metal wires.2 Nanotubes are likely to be used in a wide range of different applications across numerous industries. In the near term, nanotubes are likely to be used in applications where precise control of the position and orientation of large numbers of nanotubes is not required. Additionally, due to the current cost of the materials, early nanotube-based products are likely to incorporate only small amounts of the material. In the more distant future, improved methods of growing and processing nanotubes could unleash their potential in a range of different devices and systems, particularly in the materials, electronics, energy, and life sciences industries.3

9.2.1

Materials

Nanotubes might be used to enhance the mechanical and electrical properties of composite materials, which are combinations of different types of matter. For example, composites comprising multi-walled nanotubes for use in conductive fuel lines in automobiles are already on the market.4 Baseball players have started using

1 For a detailed overview of carbon nanotubes, see Yakobson and Smalley (1997); and Dresselhaus et al. (1996). 2 For an overview of the properties of nanotubes and citations to technical references, see generally Miller et al. (2005). 3 Some of the most disruptive applications of carbon nanotubes involve massive integration of organized nanotube architectures. For example, using nanotubes as interconnects in integrated circuits requires CMOS-compatible techniques for getting large numbers nanotubes with particular electrical properties in the proper position and location on the chip. At the time of this writing, however, manufacturers have not yet demonstrated the ability to reliably and controllably manufacture individual nanotubes directly into devices in a high volume manufacturing setting. See, for example, Fontcuberta i Morral et al. (2005). 4 See Collines and Hagerstrom (2006). Here Collines and Hagerstrom (2006, 2) note: “Carbon nanotube-filled plastics are being used in several commercial automotive applications in North America, Europe, and Japan. One application area is in fuel lines.”

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new bats that incorporate multi-walled nanotubes.5 Single-walled nanotubes, which have superior mechanical and electrical properties, might one day be used in everything from airplane wings to bullet proof vests.6 Nanotubes might also be integrated with coatings and films to give them certain properties. For example, nanotubes are being investigated for use in coatings that absorb electromagnetic inference as well as coatings that have anti-static properties (Mack et al., 2001).

9.2.2

Electronics

Carbon nanotubes are likely to have a substantial impact on the electronics industry. Because nanotubes are excellent materials for emitting electrons, they could be used in next generation flat panel displays.7 Nanotube-based field emission displays could be cheaper, provide a better picture, and consume less power than plasma and liquid crystal displays. Companies such as Motorola and Samsung have unveiled prototypes, but at the time of this writing, it is unclear if and when display manufacturers will make substantial investments in field emission displays to replace liquid crystal and plasma displays. Nanotubes might also represent a near-term solution to thermal management problems plaguing the semiconductor industry. As more and more transistors are packed on chips, microprocessors are getting hotter and noisier. The industry is searching for new types of heat sinks to control temperatures on chips. Because nanotubes have tremendous thermal conductivity, a number of firms are developing nanotube-based heat sinks. In late 2005, for example, Fujitsu announced a nanotubebased heat sink that provides high amplification and heat dissipation in highfrequency, high power amplifiers (Fujitsu, 2005). Because of the unique conducting and semiconducting properties of nanotubes, devices based on individual carbon nanotubes may eventually replace existing silicon devices. For example, several prototypes for future memory devices based on nanotubes have been demonstrated.8 In light of their high carrying capacity,

5 Easton, for example, currently sells baseball bats incorporating carbon nanotubes. For a detailed description of the product, see Easton Sports (2006). 6 For example, UT-Dallas researchers have shown that fibers comprised of carbon nanotubes are stronger than steel, Kevlar, or spider silk. See Dalton et al. (2003). See also Veedu et al. (2005). This patent notes the following: “High strength and high modulus fibers comprising single-wall carbon nanotubes are useful in a variety of applications, including, but not limited to carbon fiber production, fabrics for body armor, such as bullet-proof vests, and fibers for material reinforcement, such as in tire cord and in cement.” 7 For a comprehensive review of the electron field emission properties of carbon nanotubes, see Cheng and Zhou (2003). 8 Nantero, for example, claims that it its drop-in memory chip will come to market in 2007. See TG Daily (2006).

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nanotubes might replace copper interconnects in integrated circuits. Additionally, individual nanotubes have been shown to be superior to existing silicon transistors and diodes.9 While individual nanotube electronic devices are still being researched, films or networks of nanotubes are likely to be used in a variety of electronic products in the near future. For example, transparent, conductive films comprising of nanotubes might be used to replace indium tin oxide in touch screens, organic light emitting diodes (“OLEDs”), and electroluminescent devices. Similarly, thin film transistors based on nanotubes could complement or displace organic transistors used in flexible electronic products such as electronic paper.

9.2.3

Energy

Carbon nanotubes could play an important role in the transition to alternative energy technologies. One major obstacle in the transition to a hydrogen economy has been the lack of an effective system for storing and releasing hydrogen. Some researchers are investigating nanotubes as a new material for hydrogen storage.10 Another hurdle to widespread commercial use of methanol and hydrogen fuel cells is the exorbitant cost of the platinum catalyst in fuel cells. Several companies have successfully utilized nanotubes as catalyst support materials in fuel cells to increase efficiency and reduce the amount of platinum required. Nanotubes might also be used in different components of solar cells. Conductive and transparent films of nanotubes could be used as the electrodes in thin film solar cells (Hu et al., 2004). Alternatively, nanotubes conjugated to polymers could represent an alternative class of organic semiconducting material that can be used to make organic photovoltaics (Kymakis and Amaratunga, 2002). Substantial research has been devoted to using nanotubes in supercapacitors and batteries. Supercapacitors, which store an electric charge and release it when required, could be widely used in automobiles and power systems. Nanotubes could serve as

9 In 1998, IBM researchers fabricated field-effect transistors based on individual single and multiwall carbon nanotubes. See Martel et al. (1998). In 2002, IBM announced a prototype for a nanotube transistor that outperforms existing silicon transistors. See Martel et al. (2002). In 2005, GE Global Research announced the development of an ideal carbon nanotube diode that operates at the “theoretical limit,” or best possible performance. See Nano Science and Technology Institute 2005. 10 There is controversy surrounding the use of nanotubes for hydrogen storage. Several early experiments demonstrated impressive hydrogen storage capacities. These results, however, have not been consistently demonstrated, and there is no clear evidence that nanotubes can store the amount of hydrogen required for automotive applications. For a detailed review of the technical literature, see Hirscher and Becher (2003).

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superior electrode materials in future supercapacitors.11 Similarly, numerous companies are investigating nanotubes as electrodes in lithium ion batteries.12

9.2.4

Life Sciences

Nanotubes could also have a significant impact on the biotech, pharmaceutical, and medical device industries. Nanotubes have an affinity to be absorbed by cells, and nanotubes can be functionalized to target certain types of cells. Several research groups have published data demonstrating that nanotubes could be used as drugs or to deliver drugs to targeted cells (Wong Shi Kam, 2005). Nanotubes might also be used as miniature biosensors for drug discovery and diagnostics. Researchers have shown that nanotubes can detect small amounts of molecules through electrical, optical, or mechanical means. Such detectors might form the basis for pharmaceutical research tools that provide specific information about targets for therapeutics (Chen et al., 2005). They also open the door to pointof-care diagnostics, where patients can obtain real time information on their health by placing a drop of bodily fluid on a chip. Nanotubes might also be used in a number of different medical devices. Some researchers are using nanotubes as the scaffold material for engineering certain tissues (Zhao et al., 2005), while others are seeking to leverage the mechanical properties of nanotubes to develop lighter and stronger bone implants (Shi et al., 2005).

9.3

The Patent Landscape

The vast commercial potential for nanotube-based products outlined above explains the race by companies and institutions to establish broad patent protection. Patent claims, which are comprised of elements, determine the scope of a patent. There are three primary types of claims in carbon nanotube patents: “composition of matter” claims; “product, device, apparatus, or system” claims; and “method” claims. A product or process infringes a patent claim when every element of the claim, or an equivalent of the claim, is found in the product or process. “Building block” patents are distinguished from incremental improvement patents, which have a much narrower claim scope. “Building block” nanotube

11

In 2005, for example, a group at UC Davis published a process for making high density supercapacitors using thin films of multi-walled nanotubes. See Du et al. (2005). 12 In 2002, researchers at the University of North Carolina published data suggesting that nanotubes hold twice as much energy as graphite materials currently used as electrodes in rechargeable lithium ion batters. See Shimoda et al. (2002).

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patents generally refer to fundamental patents claiming nanotubes structures, nanotube-based products, and basic methods of making nanotubes and nanotubebased products. There are a large number of building block nanotube patents held by several different entities. Since the discovery of nanotubes in the early 1990s, substantial research dollars have poured into nanotube research at academic institutions, government labs, corporate research groups, and start-ups around the world. These institutions have aggressively sought to establish broad patent protection.13 In June 2006, Foley & Lardner and Lux Research released a report showing that 446 carbon nanotube patents having 8,557 claims, of which 420 claims are directed to “building block” type claims, have already been issued in the US (see Lux Research, 2006). With any newly emerging technology, the US Patent and Trademark Office (PTO) has the difficult task of judging the claims of the initial patent applications. The earliest patents are often awarded claims that broadly encompass downstream products resulting from future development of the technologies. As will be shown in detail later, many of the early nanotube patents issued with broad claims. It is arguable that the PTO has been more generous to nanotube patentees than patentees of other emerging technologies for two reasons. First, unlike other emerging technologies, nanotube research is interdisciplinary. Some nanotube patent applications can be characterized as “chemicals and materials engineering” inventions while others can be characterized as “semiconductor, electrical” inventions or “biotech, organic chemistry” inventions. As a result, until recently, nanotube patent applications were often directed to different centers for review at the PTO, and different examiners were reviewing similar applications against different prior art. Second, in many cases, different terminology has been used by patentees to describe similar nanotube inventions. For example, “nanofibers”, “fibrils”, and “nanotubes” have been used to describe multi-walled nanotubes14 while “single

13

For a more detailed explanation of the causes of nanotube patenting, see Serrato et al. (2005). Serrato et al. note: “There are several explanations for the compulsion to patent that has swept academic and business enterprises. In the scientific community, patents can bolster a researchers’ reputation and enhance his or her resume. In the business world, patents create barriers to entry. Companies can sometimes shut down competitors and they may also deter future companies from entering their marketplace. Patents also may enable companies to generate revenue through licensing or increase their valuation, as evidence by stock fluctuations in response to patent issuances and court decisions. Just as patents have become central components of academic and business enterprises, legal restraints on patenting have gradually eroded. As courts have chipped away at the barriers to obtaining patents, the Patent and Trademark Office has demonstrated an increased willingness to issue patents.” See also Miller et al., supra note 2, at 308 n.21 (identifying several explanations for the general explosion of patenting activity). 14 See, for example, Tennent et al. (2000). The patent notes: “The term nanofiber, nanotube, and fibril are used in interchangeably. Each refers to elongated structures having a cross section (e.g., angular fibers having edges) or diameter (e.g., rounded) less than 1 micron. The structure may be either hollow or solid.”

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shell nanocylinders”, “buckytubes”, “nanowires,” and “nanotubes” have been used to describe single-walled nanotubes.15 In other cases, patentees use similar terminology to describe different inventions. For example, two patents claiming “nanotube electrodes” might describe different device functionality and methods of fabrication, depending on what types of nanotubes were used to construct the device.16 The number of nanotube patents and patent applications is likely to steadily increase as researchers make incremental improvements in synthesizing and integrating nanotubes into products. Looking only at the large numbers of issued patents covering carbon nanotube “building blocks”, it is likely that companies seeking to make and sell nanotube-based products in a range of different industries may infringe several patents held by different entities. Whether a particular company making and selling nanotube-based products is infringing particular basic building block patents involves complicated legal and technical analysis. In many cases, the starting point for analysis is the companies’ nanotube manufacturing strategy—whether the company purchases nanotubes from an external supplier, or seeks to synthesize its own nanotubes. Dozens of companies across various industries are seeking to bring nanotubebased products to markets, using differing manufacturing strategies. For some applications, companies will purchase nanotubes from a commercial supplier and then process the materials for their specific product. For other applications, companies will seek to synthesize their own tubes as part of the manufacturing process. Table 9.1 lists the nanotube manufacturing strategies of various companies. Reliance on an external supplier can be a substantial business risk. Additionally, in many cases, the growth process must be tailored to a specific end product.

Table 9.1 Survey of manufacturing strategies Firm Product Easton

Sports Equipment

Fujitsu Hyperion Motorola Nantero Samsung Unidym

Heat Sinks Conductive Plastics Flat Panel Displays Nonvolatile Memory Flat Panel Displays Transparent Electrodes

15

Manufacturing Strategy of Firm or Its Licensee Purchase Functionalized Nanotube Solutions and Integrate into Product Direct Synthesis Direct Synthesis Direct Synthesis Purchase Nanotubes and Integrate into Product Purchase Nanotubes and Integrate into Product Direct Synthesis

See, for example, Keesman et al. (2003). The patent uses the term “single shell carbon nanocylinder” to describe a single-walled nanotube”; Li et al. (2004). This patent defines “nanowires” to include “single and multiple wall carbon nanotubes and semiconductor nanowires.” 16 For example, there is substantial interest in using carbon nanotubes as interconnects. Much of the research and data that has been generated involve multi-walled nanotubes. See Fontcuberta i Moral, supra note 3. The patents based on this research broadly claim “nanotubes.” Yet, devices based on single-walled nanotubes might be constructed and perform very differently from devices based on multi-walled nanotubes.

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For example, certain devices require direct synthesis of aligned arrays of nanotubes. However, under the “patent exhaustion” doctrine, if a company incorporating nanotubes into end products purchases nanotubes from an external supplier, the company also receives an implied license to the supplier’s patents covering those purchased nanotubes.17 Additionally, the company might obtain licenses for other patents held by the supplier covering tools for manipulating and modifying the materials.18 Therefore, a particular firm’s exposure to liability turns on the portfolio of patents and licenses held by the upstream supplier. Consider the case of a hypothetical Company X, a supplier of carbon nanotubes made through its patented process. Company X controls (i.e., it is the exclusive licensee or assignee of) a patent portfolio covering post-growth processing techniques, and it has a nonexclusive license to an appropriate composition of matter patent. If a firm’s manufacturing strategy is to purchase nanotubes from Company X and then use tools patented and controlled by Company X to integrate nanotubes into end products, then by virtue of the patent exhaustion doctrine, the patent issues are much less complex and risky than if the firm synthesizes its own nanotubes or purchases nanotubes from a different supplier. Many firms manufacturing nanotube-based products may plan to synthesize their own nanotubes instead of relying on an external supplier. In this case, the patent landscape is much more complicated to navigate because the company can no longer rely on an upstream supplier exhausting its patent rights. Such firms may

17

The “patent exhaustion doctrine” is also known as the “first sale doctrine.” According to patent law scholar Donald Chisum, “[t]he first sale doctrine operates to imply a term into the contracts for such sales of patented good giving buyers a license to use and sell that article” (Chisum et al. 2001). It should be noted that parties can contract around the doctrine such that the patent holder restricts the buyer in first sale (Id.). 18 The supply contract between the supplier and purchaser is likely to explicitly grant the purchaser a license to practice under certain patents. If the contract does not explicitly include such a license, the purchaser might still have received an implied license to practice those other patents. See, for example, United States v. Univis Lens Co., Inc. (1942): “[W]here one has sold an uncompleted article which, because it embodies essential features of his patented invention, is within the protection of his patent, and has destined the article to be finished by the purchaser in conformity to the patent, he has sold his invention so far as it is or may be embodied in that particular article.”; Met-Coil Sys. Corp. v. Korners Unlimited, Inc. 1986: “[T]his court set out two requirements for the grant of an implied license by virtue of a sale of nonpatented equipment used to practice a patented invention. First, the equipment involved must have no noninfringing use… Second, the circumstances of the sale must ‘plainly indicate that the grant of a license should be inferred.’ ”; Cyrix Corp. v. Intel Corp. 1994): “Since Cyrix’s claim 1 microprocessors cannot be used without infringing claims 2 and 6 of the 338 Patent, there are no commercially viable non-infringing uses for the microprocessors. Intel’s rights in claims 1, 2, and 6 have been exhausted. Intel may not derogate from the rights granted TI and ST under the licensing agreement by requiring their customers who purchase licensed products to sell such products only to Intel licensees.” On the other hand, an implied license might not be found. See, for example, Stukenborg v. United States 1967. Stukenborg v. United States concluded that the accused infringer did not have an implied license to use the completed assemblies, even though they were constructed in part from component parts that the accused infringer had purchased from a licensed source.

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need to obtain licenses from multiple holders of “building block” composition of matter and method patents. Firms seeking to manufacture their own nanotubes will thus likely be faced with an array of different patents that they might infringe.

9.4

Nanotube Patent Claim Validity and Scope

In light of the number of nanotube building block patents, firms seeking to develop and manufacture nanotube-based products will be required to engage in a detailed analysis of patent infringement and validity issues. As explained above, a product or process infringes a patent claim when every element of the claim, or an equivalent of the claim, is found in the product or process. There are certain to be disputes over the meaning of terms used in building block patent claims as well as whether certain products or processes infringe those claims. In many cases, however, the central question for firms analyzing building block patents held by third parties will be the validity and scope of the claims. There are several key arguments related to patent validity and scope that will likely be raised by managers and lawyers assessing the patent landscape. Four patent law doctrines likely to be used to challenge the validity of nanotube patents are: ● ●

●

●

Whether carbon nanotubes are “patentable subject matter” under 35 U.S.C. § 101; Whether prior art “anticipates” (or inherently anticipates) the patent under 35 U.S.C. § 102; Whether the patent is “obvious” in light of the prior art under 35 U.S.C. § 103; and Whether the patent adequately discloses and enables the invention under 35 U.S.C. § 112.

9.4.1

Section 101: Subject Matter Patentability of Composition of Carbon

Federal patent law, which is codified in the United States Code at 35 U.S.C. § 101 et seq., allows inventors to patent their inventions or discoveries, whether they are devices, processes, methods of production or use, or even compositions of matter such as a chemicals.19 However, laws of nature and natural phenomena are generally not patentable. As the Supreme Court explained in the seminal Diamond v. Chakrabarty (1980) case:

19

See 18 U.S.C. § 101: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

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“[A] new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E = mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of nature, free to all men and reserved exclusively to none.’ ” Thus, a likely initial challenge to the validity of patents claiming nanotube compositions of matter is that the carbon nanotube structure is a “natural phenomena,” akin to a “new mineral discovered in the earth,” and thus not patentable subject matter. Carbon nanotubes may, in fact, occur bountifully in nature. Scientists have found that carbon nanotubes naturally occur in coal and even charcoal.20 The validity of the key carbon nanotube composition of matter patent claims— NEC’s patent claim covering nanotubes (US Patent 5,747,161) and IBM’s patent claim on single-walled nanotubes (US Patent 5,424,054)—will thus likely be challenged on subject matter patentability grounds. Firms may argue that the carbon nanotube structure itself is a naturally occurring phenomena, and thus not patentable. Holders of these composition of matter patents will likely counter such invalidity arguments by citing the cases upholding gene patents as not involving “natural phenomena” because the inventors had “isolated” or “purified” the gene fragment from the human genome (Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd, 1989). Similarly, patent holders would likely argue they had isolated and characterized the carbon nanotube structure, and thus are entitled to patent it. Notably, however, another composition of carbon, the buckminsterfullerene (also known as carbon-60), was isolated and characterized in 1985, but was not patented. Some commentators have suggested that it may have been unpatentable as a naturally occurring product of nature (Lemley, 2005). Such arguments have not been tested in court, and because patent law doctrine relating to patentable subject matter generally is still in flux, it is difficult to predict how successful this argument would be.

9.4.2

Section 102: Novelty and Anticipation by Prior Art

A patented invention must be “novel”—that is, it must not have been already disclosed in “prior art” such as an earlier patent or scientific publication. Even if every aspect of the invention was not fully disclosed in the prior art, an invention may still be invalid under “inherent anticipation” if “the claim limitation or limitations not expressly found in that reference are nonetheless inherent in it” (MEHL/ Biophile Int’l Corp. v. Milgraum, 1999). Carbon nanotube patents will likely be repeatedly challenged as being anticipated (or inherently anticipated) by prior art.

20

Gogotsia and Libera (2000) (carbon nanotubes naturally formed in many types of coal); Shibuya et al. (1999) (finding C60 present in commercial charcoals); Fang and Wong 1997 (finding C60 and C70 in coal samples).

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One argument that will be advanced to challenge composition of matter patents is whether any prior art on carbon fibers anticipates the carbon nanotube structures. Carbon fibers have a rich history of research dating back to 1890 (Schutzenberger and Schutzenberger, 1890), and since at least the 1970s, scientists have explored properties of tiny “carbon fibrils.” For example, in 1976, researchers in France and Japan published an article entitled “Filamentous Growth of Carbon Through Benzene Decomposition,” which described the creation of hollow tubes of carbon fibers (Oberlin et al., 1976). These tubes were made of “concentric sheets of carbon, set around the fibre axis, as the annual rings of a tree.” The researchers describe the tube as “running parallel to the axis… the diameter of which widely varies from about 20 Å to more than 500 Å” (Oberlin et al., 1976, 336–337). One of the 1976 article’s authors, Morinobu Endo (1988), also published a subsequent article in 1988 entitled “Grow Carbon Fibers in the Vapor Phase: What You Can Make Out of These Strong Materials and How to Make Them.” In this article, Endo described the creation and properties of fibers made up of concentric layers of carbon, with a hollow tube in the center about ten nanometers or less in diameter. Fig. 9.1 compiles an assortment of images taken from Endo’s 1988 article, which may be used, for example, as prior art anticipating a multi-walled carbon nanotube. In a later interview, Endo characterizes this hollow tube as a carbon nanotube (Forman, 2006). Endo has been called “one of the fathers of the carbon nanotube,” and was recently awarded Small Times Magazine’s Lifetime Achievement award for his work on multi-walled carbon nanotubes (Gardner, 2006). Another set of early researchers working with carbon fibers were R.T.K. Baker and P.S. Harris, who in 1978 published an article entitled “Formation of Filamentous Carbon” in Chemistry and Physics of Carbon which described hollow carbon filaments with nanometer scale diameters (Baker and Harris, 1978). The IBM single-walled nanotube patent (US Patent 5,424,054) referenced this article as potential prior art, but distinguished its disclosed process as being capable of only producing filaments

Fig. 9.1 Seeded microparticle at the end of the growing VGCF (a) (from a collaboration with A. Oberlin) and a thin fiber with continuous hollow tube (b). (Reprinted from Endo, 1988. Copyright (1988) American Chemical Society)

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with large diameters generally greater than five nanometers. Based on this distinction, the IBM patent was able to claim a “hollow carbon fiber having a wall consisting essentially of a single layer of carbon atoms.” In addition to such published articles, various patents relating to carbon fibers may be used as prior art to challenge certain carbon nanotube patents. Hyperion Catalysis International is the assignee of two patents (No. 4,663,230 and its continuation-in-part, No. 5,165,909) which claim compositions of carbon fibrils and methods of producing them. For example, Hyperion’s ‘230 patent, which issued in 1987, claimed an “essentially cylindrical discrete carbon fibril characterized by a substantially constant diameter between 3.5 and about 70 nanometers….” The PTO considered Hyperion’s patent in reviewing the IBM patent application, and still granted the claims. These above examples of potential prior art from the 1970s and 1980s will likely be among the first to be used to challenge the validity of patents claiming nanotube compositions of matter. Some of this prior art has previously been reviewed by the PTO and deemed (at the time) as not invalidating the nanotube patent under review. However, patent holders can expect close scrutiny of this and other prior art by firms investing in nanotube-based products. Even if such prior art does not expressly describe every claimed property or element of the nanotube invention, they may still invalidate a nanotube patent under the doctrine of “inherent anticipation.” Courts have invalidated patents when elements of the patent’s claims are not expressly described in prior art, but are necessarily implied so that a person of ordinary skill in the art would recognize it (see Continental Can Co. v. Monsanto Co., 1991). If the prior art describes a composition of matter without describing certain elements or properties that are necessarily present (or “inherent”) in that composition, such prior art might inherently anticipate a patent on that composition of matter. For example, scientists have recently discovered that the seventeenth century “Damascus sabers,” which were famed for their strength and exceptionally sharp cutting edge, were crafted through a special process that incorporated carbon nanotubes in the blade (See Reibold et al., 2006); Fountain, 2006). Some manufacturers of structural composites comprising nanotubes, for example, may try to argue that this prior use of carbon nanotubes as a structural reinforcement, although not expressly disclosed in any prior art, inherently anticipated certain claims related to carbon nanotubes.

9.4.3

Section 103: Non-obviousness

Section 103 requires that a patent be “non-obvious,” so that the differences between the prior art and the claimed invention would not be obvious to a “person having ordinary skill in the art” (or “PHOSITA”) (see Graham v. John Deere Co., 1988). Some firms will likely challenge the non-obviousness of nanotube patent claims, arguing that they are merely smaller versions of the prior art. For example, it is arguable that many of the claimed inventions relating to multi-walled carbon

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nanotubes are obvious in light of the prior art on carbon fibers, and that many of the claimed inventions relating to single-walled carbon nanotubes are obvious in light of the prior art on multi-walled carbon nanotubes. Merely making something smaller is unlikely to make an invention non-obvious, but the new, unique properties of the claimed invention that result from the smaller size may be sufficient. More importantly, if the prior art does not enable an invention to be practiced, then the prior art would not render the invention obvious.21 Thus, for example, the prior art related to a composite material comprising carbon fibers may not enable the unique properties of the composite material comprising multi-walled nanotubes, and the prior art on composites comprising multi-walled nanotubes may not enable the unique properties of the composite material comprising single-walled nanotubes. One of the first Federal Circuit cases concerning nanotechnology, In re Kumar, concluded that the prior art did not enable the nanoscale properties claimed in the patent at issue, and thus rejected the PTO’s argument for rejecting the patent on obviousness grounds.22 Several other questions remain regarding the application of the obviousness requirement to nanotube inventions. At the time of this writing, it is unclear whether the USPTO will treat nanotube research like biotechnology, where the lack of extensive prior art created a relatively low bar for demonstrating non-obviousness, or like materials manufacturing, where centuries of prior art has risen the level of expectation very high.

9.4.4

Section 112: Written Description and Enablement

Section 112 requires that the patent “contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.”23 Applying this enablement requirement to nanotechnology inventions raises several new questions for courts to address. Many carbon nanotube patents contain notably broad claims, which might not be fully enabled by the written description in those patents. For example, many carbon nanotube patents simply use the term “nanotube” in the claims, without distinguishing between multi-walled carbon nanotubes and single-walled carbon

21

See Koppikar et al. (2004). Koppikar et al. note: “If the prior art does not enable one to make a smaller version of an existing device at the nanoscale, then the resulting nanoscale version of the same device may in fact be non-obvious over its larger cousin even if there is no difference other than size” (emphasis in original). 22 In re Kumar, 418 F.3d 1361 (Fed. Cir. 2005). See also Baluch et al. (2005). 23 35 U.S.C. § 112.

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nanotubes. Single-walled carbon nanotubes are more difficult to produce and to manipulate post-production; thus a patent claiming “nanotubes” that only enabled multi-walled carbon nanotubes may be limited by lack of enablement. However, considerable uncertainty exists as to what level of scrutiny the PTO and the courts will use in evaluating the enablement of nanotechnology patents. Courts have imposed different levels of scrutiny for different high tech fields. The threshold for showing enablement has traditionally been low in the semiconductor field, while being very high in the biotechnology field.24 Consequently, many biotech patent claims have been invalidated on § 112 enablement grounds. Carbon nanotubes have applications in both the semiconductor and biotech fields, and it remains to be seen how nanotube patents not specifically related to those fields will be treated. Because the legal uncertainties create doubt as to the validity and scope of nanotube patents, the task of navigating the patent thicket is even further complicated.

9.5

Impact of the Carbon Nanotube Patent Thicket

Numerous firms—both large and small—that have already invested or are considering investing in products based on carbon nanotubes face the prospect of patent infringement. The large number of nanotube building block patents and accompanying legal uncertainties could both, in limited cases, stifle investments in mass production of nanotube products, and, in many cases, impose significant costs on companies seeking to develop and manufacture nanotube-based products.

9.5.1

Avoidance of Major Capital Investments

The difficulty in navigating the nanotube patent thicket may curtail substantial investments in research, development, and manufacturing of nanotube-based products.25 For some large existing companies, the costs of navigating the patent minefield will outweigh the gains of improved products (Shapiro, 2001). As a result, some large firms may be reluctant to invest in major product development efforts based on nanotubes. At the very least, it is safe to assert that patent issues could force large companies to consider potentially more costly and less effective

24

For a detailed discussion of the application of the enablement doctrine in biotechnology and how it might be applied in nanotechnology, see Schwaller and Goel (2006). See also Miller et al., supra note 2, 221–222. 25 In academic legal literature, this argument is generally described as the “tragedy of the anticommons.” See generally Heller and Eisenberg (1998). Heller and Eisenberg argue that the large number of patents on gene and gene fragments will deter research and development of downstream therapeutic applications.

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technological alternatives to carbon nanotubes. More pronounced, however, may be the effect on blocking a start-up from successfully commercializing a specific nanotube-based product. Startups do not have the resources to navigate through the patent thicket, and venture capitalists will be reluctant to invest in start-ups if they are concerned that the company is at risk of patent infringement liability. It is nearly impossible to quantify how much capital would flow to nanotubebased product development efforts absent the uncertain patent landscape. Anecdotal evidence suggests that, in at least some circumstances, large companies and investors are still shying away from making substantial investments that they would otherwise have made.

9.6

Costs Imposed by Patent Thickets

For those firms that do invest in manufacturing nanotube-based products, the patent thicket is likely to impose a variety of different costs. Firms will take different approaches in addressing the patent landscape, and patent holders will utilize their building block patents in different ways. For example, in some instances, firms may voluntarily seek to obtain licenses from holders of certain building block patents. In other cases, firms will not seek licenses from holders of building block patents to avoid having to pay royalties and disclose sensitive information about their development and production plans.26 Rather, they will take the position that either they are not infringing or the patent claims covering their product are invalid. Similarly, some patent holders will seek to use their patents to obtain injunctions against competitors while others adopt strategies of widespread, non-exclusive licensing. As such, individual patent disputes may be resolved in a variety of different ways ranging from litigation to licensing. There are two categories of nanotube patent disputes that firms will encounter—intra-industry and interindustry patent disputes.

9.6.1

Intra-Industry Patent Disputes

“Intra-industry” disputes refer to conflicts over nanotube patents between competing firms commercializing substitute products. Such a dispute could possibly involve infringement by one firm of patents held by a second firm without infringement by

26

To some extent, the willingness to disclose sensitive information depends on what stage the firm is at in product development. If licensees seek licenses before their final product has been developed, they will be more reluctant to disclose sensitive information. Further, even if a firm is comfortable disclosing such information under a confidentially agreement, it is difficult to negotiate fair consideration for a license until the final product and scaled manufacturing process has been fully fleshed out. If licensees seek licenses after production and shipping has begun, there are still significant obstacles to negotiating licenses. Miller et al., supra note 2, at 75 (citing Scotchmer 1991).

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the second firm. It is more likely, however, that intra-industry disputes will involve mutual infringement by two competitors holding blocking patents. Firm A might hold basic building block patents that are infringed by Firm B, while Firm B holds applied building block patents that are infringed by Firm A. Both firms may hold basic building block patents that are mutually infringed, or both firms may hold applied building block patents that are mutually infringed. Whether these disputes are resolved through cross-licensing or litigation will turn on the particular circumstances of the conflict and the culture of the particular industry. In the semiconductor industry, for example, there is a great deal of reciprocal infringement and cross-licensing between parties.27 Often, tacit cross-licensing arrangements are used instead of formal agreements.28 In contrast, the life sciences industry is filled with protracted litigants seeking injunctions.29 For example, several large companies in the semiconductor industry are developing heat sinks based on carbon nanotubes. It is likely that at least two of these companies will have mutually infringing patents related to such heat sinks. Even if they do not, they probably have mutually infringing patents on other technologies and products. Therefore, if both companies compete to make and sell nanotubebased heat sinks, any patent issues are likely to be resolved through cross-licensing. On the other hand, if a smaller, venture-backed company is competing in the thermal management market, the outcome might be different. Assuming the smaller company and the large semiconductor companies each hold patents being infringed by the other, the large semiconductor companies may decide to litigate rather than engage in cross-licensing. In this case, the large semiconductor companies can use their size and legal prowess as competitive tools against the smaller company. Litigation could frustrate the smaller company’s ability to raise additional capital necessary for expansion and distract time and attention of management away from product development and marketing efforts. Similarly, if two small companies competing to make and sell nanotube-based biosensors hold mutually infringing patents, it is impossible to predict ex ante whether cross-licensing or protracted litigation would be more likely. The two companies may calculate that it is in their best interests to share the market and compete on the basis of their products. Alternatively, one company may decide that it is more likely to prevail in litigation and obtain an injunction against the other company.

27

Miller et al., supra note 2, 75 (“[I]n the semiconductor industry, several firms maintain more than 1,000 patents, and there is a high level of reciprocal infringement.”) (citing Barton 2002). 28 Firms find it rational to “forego full enforcement of property rights in exchange for reciprocal forbearance from competitors” (Merges 1996). 29 See Allison and Lemley 2002. Allison and Lemley state: “[B]iotechnology and pharmaceutical patents are more frequently litigated than patents in other industries and are often for entirely new products” (p. 137).

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Inter-Industry Patent Disputes

“Inter-industry” disputes refer to conflicts over patents between entities that are not competing. Holders of basic building block patents are unlikely to establish crosslicensing agreements with holders of applied building block patents when the firms are in different industries. For example, a firm that directly synthesizes its own nanotubes on substrates for flat panel displays could be infringing patents held by IBM, NEC, and a few universities. Yet, these patent holders may not be infringing any patents held by the display company. Similarly, a company in the semiconductor industry that infringes several patents covering CVD growth of nanotubes held by different universities is unlikely to establish cross-licensing agreements with the universities.

9.6.3

Transaction Costs Posed by These Patent Disputes

While each patent dispute may be resolved differently depending on the circumstances, the aggregate cost for any given firm in navigating the patent thicket is likely to be substantial. First, firms will bear transactional costs associated with identifying and evaluating the validity of certain patents, responding to enforcement activities, negotiating settlements and license agreements, and financing litigation activities. The cost of each dispute can vary considerably from tens of thousands of dollars to millions of dollars, depending on the circumstances and willingness to litigate. Second, firms will experience intangible business costs in the form of management distractions. Additionally, firms may find it difficult to secure supply or joint development agreements with customers or partners due to concerns about the complicated patent landscape. At the very least, firms will need to devote a significant amount of resources to convincing third parties that they have a defensible intellectual property strategy. Third, firms are likely face demands by patent holders to pay aggregate royalties in excess of the maximum amount they are willing to pay. The intellectual property platform required to manufacture nanotube-based products can be considered an input that firms must purchase in order to manufacture an end product. The price a firm can charge for an end product will vary greatly from product to product and from industry to industry. In each case, however, there is a maximum price manufacturers are willing to pay for the intellectual property platform in order to make the production of the end product a profitable enterprise. Therefore, if the basic platform required to manufacture a nanotube-based product is comprised of eight building block patents held by five different entities, an optimal outcome for the patent holders is to find an equitable way to share the maximum price a manufacturer is willing to pay for the platform. Anecdotal evidence suggests that, when individual patent holders are negotiating the consideration for their relative percentage of the platform, they are likely to demand an amount that, if demanded by all patent

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holders, would result in a total price greater than the maximum price a manufacturer is willing to pay. Each patent holder is likely to overvalue its intellectual property as a component of the total process and not take into consideration enforcement efforts by other patent holders.

9.7

Proposal for Industry: A Nanotube Patent Forum

Do nanotube patent thickets mean that commercialization roadblocks and costly patent disputes are unavoidable? Some commentators have proposed the formation of a patent pool on “building block” nanotube patents. Pooling of the building block nanotube patents is unlikely. First, patent pools have historically been successful when they involve similarly sized patent holders in the same industry with mutually infringing patents. With carbon nanotubes, the key patents are held by different universities, government labs, large companies, and start-ups focused on different industries. Second, there are no industry-established standards related to nanotubes and nanotube-based products. The approved MPEG patent pool offers licenses to sets of “essential” patents that are infringed by products made according to industry standards (MPEG-2 Business Review Letter, 1999). Essential patents by definition have no substitutes; one needs licenses to each of them in order to comply with the standard. Unlike MPEG, however, there are no standards covering integration of nanotubes into different product lines. Efforts to establish patent pools where no standards exist would likely trigger strict antitrust scrutiny from the Department of Justice. Third, manufacturers of nanotube-based products generally need licenses to different sets of “building block” patents. For example, one manufacturer may need licenses to three patents while another manufacturer may need licenses to four patents. It may be difficult to develop formulas to charge different royalty rates to different manufacturers based on licenses to different patents. Finally, the licensing managers at the companies and universities holding the key patents may not yet recognize the impact of the nanotube patent thicket. Additionally, in many cases, they believe that their institutions can maximize the value of their intellectual property by engaging in unilateral enforcement and licensing efforts. Only if these individuals begin to perceive the undesirable effects of the patent thicket and begin to understand how their institutions would benefit from patent pooling can any meaningful progress toward patent pooling arrangements be expected. Notwithstanding the obstacles to patent pooling arrangements, it is possible that some of these issues might be resolved and some types of patent pools involving carbon nanotubes will eventually be established. In the meantime, there is some evidence of consolidation of carbon nanotube patent portfolio holders and the development of carbon nanotube patent license “packages.” On April 23, 2007, Carbon Nanotechnologies Inc., a Texas-based manufacturer of carbon nanotubes and Unidym, a developer of nanotube-based

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electronics in Silicon Valley, announced the merger of the two companies. The resulting entity, named Unidym, now commands a broad nanotube patent portfolio, including patents on nanotube structures, methods of fabrication and refinement, and certain biomedical applications. By offering a nanotube license package, Unidym seeks to simplify the patent landscape for companies seeking to commercialize nanotubes. However, the patent landscape still remains fragmented, and further steps should be taken by industry, universities, and government to facilitate investments in nanotube-based products and reduce wasteful transaction costs. The industry would benefit from the launch of a “Nanotube Patent Forum.” Such a Forum would involve a series of dialogues between the holders of “building block” patents and manufacturers of nanotube-based products. The forum would be open to anyone, but should at least include participation by key patent holders such as IBM, NEC, Hyperion, Intel, GE, Nantero, Unidym, Rice University, Stanford University, and others. The primary purpose of the Forum would be to provide patent holders with insight into the appropriate royalty streams they should expect in light of the royalty streams being demanded from other patent holders. One of the most costly issues associated with navigating the carbon nanotube patent thicket involves the uncertainties and complexities associated with negotiating multiple licenses with different patent holders. A Forum dedicated to bringing together the different patent holders with firms developing and manufacturing nanotube-based products could go a long way toward reducing these transaction costs. Patent holders would gain a better sense for what they should expect in terms of royalty streams when enforcing their patents. Additionally, universities would obtain information about how to structure license agreements for new intellectual property developed on downstream products incorporating nanotubes. For example, if a university develops intellectual property covering a new nanotube-based product and is seeking to license this intellectual property to a firm, the university and firm must come to some agreement about the appropriate consideration for the license. This negotiation will be more productive and efficient if both parties have some understanding of the royalties that the firm must also pay to other patent holders from which it must obtain licenses. At the same time, managers at large companies considering substantial investments in nanotube-based product lines could gain some insight into the costs of obtaining the licenses necessary to have freedom to operate. Perhaps the key to the success of the Forum is participation by the Department of Justice. In light of the antitrust laws governing patent pooling, most parties will be unlikely to engage in a formal dialogue about nanotube patent licensing issues without approval from the Department of Justice. Not only is government involvement essential to legitimizing the Forum, but attendance by the Justice Department officials would be important to ensure that the content of the Forum is in accordance with antitrust laws. The commercial potential of carbon nanotubes is vast, but the corresponding patent thicket is daunting. A Nanotube Patent Forum would be a beneficial step towards making it much easier for companies to navigate the thorny carbon nanotube patent landscape.

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Chapter 10

Ethical Aspects of Nanomedicine: A Condensed Version of the EGE Opinion 211 European Group on Ethics

10.1

Introduction

Nanoscience is the study of the properties of materials and their manipulation at the atomic, molecular and macromolecular scales, where properties differ significantly from those at a larger scale. Nanotechnology is the development and practical applications of structures and devices on a nanometre scale in several fields including medicine. The European Science Foundation (ESF) defines nanomedicine as “the science and technology of diagnosing, treating and preventing disease and traumatic injury, of relieving pain, and of preserving and improving human health, using molecular tools and molecular knowledge of the human body” (ESF Forward Look on Nanomedicine, Nov 2005). It embraces five main sub-disciplines that in many ways are overlapping and underpinned by common technical issues: ● ● ● ● ●

analytical tools; nanoimaging; nanomaterials and nanodevices; novel therapeutics and drug delivery systems; and clinical, regulatory and toxicological issues.

1

EGE (European Group on Ethics in Science and New Technologies to the European Commission), Opinion on the ethical aspects of nanomedicine. Opinion No. 21, January 17, 2007 Brussels: European Commission. The full text can be downloaded from http://ec.europa. eu/european_group_ethics/index_en.htm. It should be made clear that this condensed version does not replace the original, because it does not contain the appendices, the supplementary information, the illustrations, and the many references of the original text. This condensed version has been prepared by Göran Hermerén, chairman of the EGE and one of the rapporteurs of this Opinion. The other rapporteurs were Krzysztof Marczewski and Linda Nielsen. The text has been distributed to the members of the EGE for comments before it was sent to the editors of this volume.

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Scientific and Technical Background

The potential of nano-technologies raises great hopes. Far-reaching claims are made by both opponents and proponents. The first difficulty in describing the state of the art accurately is to distinguish between science and science fiction, i.e. between the state of the art today, what may be around the corner tomorrow and what remains highly speculative. The ethical issues raised at these stages are not necessarily the same.

10.2.1

Nanomedicine: The State of the Art

Potential applications of nanomedicine have been discussed in many of the reports on nanotechnology and nanoscience, for example those published in the UK, Norway, the Netherlands and Canada, as well as by Unesco. An overview is also available in the proceedings of the Roundtable on Nanomedicine organised by the Commission and the EGE. It has been claimed that clinical use in the short term includes therapies for cancer, antiviral and antifungal agents, arteriosclerosis, diabetes, and chronic lung diseases. In the longer term, clinical applications are likely to involve gene therapy and cell repair. 10.2.1.1

Diagnostic Techniques

New in vitro diagnostic tests based on nanodevices may shift diagnosis to a presymptomatic stage and allow pre-emptive therapeutic measures with less invasive methods of extraction. The technology may therefore allow the use of cost-effective diagnostic systems with higher performance in terms of resolution, sensitivity, specificity, reliability, reproducibility and integration. Diagnostic techniques can be either in vitro or in vivo. In vitro techniques are used in a wide variety of analyses including blood, urine and biopsies. Nanotechnologies may be used to improve the performance of DNA chips and protein chips, and offer the potential to enhance resolution down to a single molecule analysis of standard samples. A nanowire array might test a mere pinprick of blood (which is minimally invasive) in just minutes, providing a nearly instantaneous scan for many different cancer markers. Such devices could open up substantial new possibilities in the diagnosis of cancer and other complex diseases. Hand-held diagnostic kits may be used to detect the presence of several pathogens at once and could perhaps be used for wide-range screening in small peripheral clinics. In vivo techniques include biosensors, implants and surgical tools. Subcutaneous chips are already being developed to continuously monitor key body parameters

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including pulse, temperature and blood glucose. Implantable sensors can also work with devices that administer treatments automatically if required, e.g. fluid injection systems to dispense drugs.

10.2.1.2

Imaging

Nanotechnologies may allow a more precise diagnosis than is presently possible. As an example, ultra small, super-paramagnetic iron oxides, with a diameter of less than 50 nm, allow the imaging of organs and have been successfully evaluated for improved lymph node metastases detection in various clinical trials. There are many other techniques in use or at the design stage that use nanoparticles to assist in the imaging process or that use nano-techniques to provide images of living systems. These techniques can be both in vivo, for example contrast agents introduced in the body, and ex vivo, such as specific markers used in histology.

10.2.1.3

Biomaterials

Significant efforts to mimic biological materials with man-made materials are being made in order to improve their function within biological systems. Nanotechnologies may provide new approaches in this direction. For example, the nanotechnologies currently developed may be used to increase the mechanical properties and biological compatibility of prosthetic and dental implants, catheters, wound dressings and medical instruments. By applying bioactive nanoparticle coatings on the surface of implants, it will be possible to bond the implant more naturally to the adjoining tissue and significantly prolong the implant lifetime. Silver nanoparticles are also being used in antibacterial coatings for implants, catheters, wound dressings and medical instruments.

10.2.1.4

Drug Development and Delivery

Drug delivery may be one of the main applications of nanotechnologies in medicine. Pharmaceuticals embedded or enclosed in targeted nanocarriers may allow a new degree of specificity and efficacy in the delivery of drugs. A key characteristic of nano-pharmaceuticals is their complexity: they can combine several characteristics. They could deliver therapeutic molecules directly across biological barriers (such as the blood-brain barrier or the blood-retina barrier) by bearing specific molecules or charges on their outer shell. At the same time this shell could include specific reagents such as antibodies that bind to specific targets. The carrier could be made of physiologically stable material, which only disintegrates on binding to its target (or on receiving an external signal, administered by the practitioner). This would allow the delivery of high-potency pharmaceuticals

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which either could have adverse effects when administered systemically or may not be administered successfully by conventional methods at all. The benefit of new drug delivery systems for the patient will be fewer side-effects, improved efficacy and the treatment of diseases and disease stages that currently cannot be effectively treated. Novel forms of therapy are possible too. For instance, iron nanoparticles can be enriched in cells of malign brain cancer and will create local heating when the practitioner places the patient in an external magnetic field–thereby enhancing the effects of chemo- and radiation-therapy. In conjunction with pharmacogenetics and pharmacogenomics, nanomedicine may help to offer “personalised” pharmaceutical therapy.

10.2.1.5

Other Potential Health-Related Applications of Nanotechnologies

Regenerative medicine. The potential applications of nanotechnology in regenerative medicine include improvement in the activation of genes that stimulate regeneration of living tissues; production of nano- and micro-engineered biocompatible membranes; improvement in the performance and duration of neural prostheses; faster regeneration of novel bone substitutes; and creation of a new lymphocyte factory that re-establishes normal immune response in a patient. Stem cell therapy. Stem cell therapy combined with nanotechnology, based on magnetic cell sorting, offers promising possibilities for the regeneration of diseased tissue. Stem cells may be identified, activated and guided to the place of damage within the body with the use of cell–signalling molecules as a source of molecular regeneration messengers. Implants. With regard to the use of electronic nanodevices, it has also been advocated that nano- and related micro-technologies might be used to develop a new generation of smaller and potentially more powerful devices to restore loss of vision.

10.2.1.6

Cosmetic Applications

One major area of health related non-medical nanotechnological applications is in the field of cosmetics. A number of cosmetics products using nanotechnology are already on the market. The market is growing at about 10% a year and companies believe that nanotechnology will help to create a new generation of products. But both US Food and Drug Administration and the Royal Society in Britain have stressed a lack of knowledge concerning potentially toxic effects of nanocosmetics.

10.2.1.7

Toxicological Aspects

Toxic effects of some nanoparticles have been already demonstrated in cells, tissues and small animal experiments.

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Nanoparticles can deposit in the respiratory tract after inhalation. Only a few specific nanoparticles have been investigated in a limited number of test systems, and extrapolation of this data to other materials is not possible. There are examples indicating that known and widely accepted toxicological methods are not sufficient to detect possible damaging effects of nanoparticles.

10.3

Legal Background

The current legal systems in Europe were not designed for nanomedicine as such; but this does not mean that nanomedicine is unregulated.

10.3.1

The Legal Situation: An Overview

Most of the existing regulations result from transposition of the relevant EU legislation into the national legal systems. This is supplemented by some global provisions, issued by the World Trade Organisation (WTO), and an international framework on ethics and human rights. 1. European Union (EU) legislation on products, clinical trials, data and patents Medicinal products - Medical devices - Cosmetics - Chemicals - Clinical trials - Data protection (personal data) - Other relevant EU legislation 2. Global provisions issued by the World Trade Organisation (WTO), including General Agreement on Tariffs and Trade (GATT), Sanitary and PhytoSanitary (SPS) agreement on trade and Trade-Related Aspects of Intellectual Property Rights (TRIPS) 3. International framework on ethics and human rights, including: the Council of Europe Convention for the protection of human rights and fundamental freedom; the Council of Europe Convention on human rights and biomedicine; the EU Charter of Fundamental Rights; the UNESCO Declaration on the human genome and human rights; and the UNESCO Declaration on bioethics and human rights. Legislation adopted by the European Union is binding for the Member States, but there are differences in the nature of obligations. The data protection and patent provisions are binding for the EU Member States. WTO agreements ratified by a great number of nations form the legal ground rules for international commerce. They are binding for the States that have signed and ratified them. The Council of Europe Convention on human rights and biomedicine, based on the Convention for the Protection of Human Rights and Fundamental Freedom, is binding for the States that have signed and ratified it, but not all EU countries have done so. However, European projects funded under the EU research framework programs have to comply with the principles enshrined in that Council of Europe Convention.

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The UNESCO Declarations and the EU Charter of Fundamental Rights are not legally binding, but they have moral authority. All three types of rules may be supplemented by national regulation.

10.3.2

EU Legislation

There is a wide range of Community legislation related to issues relevant for nanotechnology and nanomaterials, currently in existence or being elaborated. Examples of legislation relevant for nanomedicine are the following: Medicinal Products. Medicinal products marketed in the European Union are covered by comprehensive EU legislation. Medicinal products are defined in the EU legislation as follows: “Medicinal product: Any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.” (Art. 1.2; 2001/83/EC 58) All medicinal products marketed in the European Union must obtain an EU product authorisation. A medical device is defined as: “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories, including the software necessary for its proper application intended by the manufacturer to be used for medical purposes for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease,…” (Art. 1, Directive 93/42/EC). Directive 726/2004 deals primarily with risk management. Manufacturers are obliged to carry out an assessment of the risks and to adopt a risk management strategy. This means that they have to adopt measures to eliminate risks, or to reduce risks as far as possible, take the necessary protection measures in relation to risks that cannot be eliminated and, as a last resort, inform users of the residual risks due to any shortcomings of the protection measures adopted and advise any other protective measure regarding risks that cannot be eliminated. Cosmetics. Cosmetic products are also covered by an EU Directive. A “cosmetic product” is defined in Article 1 as: “any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”. According to Article 2, “a cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product’s presentation, its labelling, any instructions for its use and disposal as well as any other

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indication or information provided by the manufacturer or his authorised agent or by any other person responsible for placing the product on the Community market”. The Directive lays down requirements in the form of a number of positive and negative lists of ingredients. The basic obligation on a manufacturer is to carry out a risk assessment. But this Directive does not provide for verification of the manufacturer’s risk assessment by a third party before the product is placed on the market. Chemicals. Chemicals are embraced by one set of rules concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), which introduces several changes to the current regulatory system. Clinical Trials. Clinical trials for medicinal products are covered by an EU Directive on Clinical Trials, which was amended in 2003 and 2005. The purpose is to rationalise the procedure involving documentation and administration required for conducting clinical trials, and to ensure that patients are afforded the same protection in all EU Member States. Data Protection. Data protection is covered by the Directive on the processing of personal data and the protection of privacy in the electronic communications sector. Patents. The Patent Directive is designed to ensure effective legally harmonised protection of patents, to encourage innovation and promote investment in the field of biotechnology, and to establish legal certainty. The patent may be a product claim or a process claim. Other. Other European Union legislation of specific importance for risk assessment issues includes, among others, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms.

10.3.3

World Trade Organisation (WTO) Agreements and Trade-Related Aspects of Intellectual Property Rights (TRIPS)

The mission of the World Trade Organisation (WTO) is to develop a multilateral system of trade, the aim of which is to lower customs and trade barriers, and to abolish discrimination in international trade. The heart of the WTO system is the agreements, negotiated and signed by a large majority of the world’s trading nations and ratified by their parliaments. These agreements are the legal ground rules for international commerce. The General Agreement on Tariffs and Trade (GATT) and the Sanitary and Phyto Sanitary (SPS) agreement include measures that might impact on trade between nations and stipulate, for example, that measures may not be introduced in breach of the principle of non-discrimination if these are based on the precautionary principle. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement also contains a provision (Article 25(2) ) allowing Member States to exclude from

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patentability inventions that are contrary to ordre public or morality, or in order to protect human, plant or animal life, or in order to avoid serious detriment to the environment. It is unclear how the clause on morality in the TRIPS agreement will be implemented for nanomedicine.

10.3.4

Framework on Ethics and Human Rights

The main purpose of the Council of Europe Convention on Human Rights and Biomedicine is to protect individuals against exploitation arising out of treatment or research. The Convention is supplemented by a number of additional protocols. The Universal Declaration on the Human Genome and Human Rights, adopted by UNESCO’s General Conference in 1997 and subsequently endorsed by the United Nations General Assembly in 1998, deals with the human genome and human rights. The European Charter of Fundamental Rights emphasises that the Union is founded on the indivisible and universal values of human dignity, freedom, equality and solidarity and on the principles of democracy and the rule of law. The Charter formulates a common set of basic shared values at EU level. Respect for human dignity, a ban on human reproductive cloning, respect for people’s autonomy, non-commercialisation of biological components derived from the human body, prohibition of eugenic practices, protection of people’s privacy, freedom of science are examples of values enshrined in the Charter, adopted in 2001.

10.3.5

Regulatory Concerns

The regulatory concerns include a number of questions: 1. Does regulation embrace the relevant areas of nanomedicine, so that no major area is left out? 2. Is the legislation clear and comprehensive, without overlap? 3. Does regulation secure adequate protective measures, including evaluation of health-related risks? 4. Is the implementation of existing regulations adequate? 5. Is the present patent system adequate to deal with problems regarding knowledge protection and information dissemination in nanomedicine? 6. What are the challenges for future regulatory discussions?

10.4

Ethics Governance, and Policies: Problems and Concerns

All areas of science and new technology developed within the European Union must be consistent with the ethical principles stated in the European Charter of Fundamental Rights.

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Against this background the questions arising are: How should the dignity of people participating in nanomedicine research trials be respected? How can we protect the fundamental rights of citizens that may be exposed to free nanoparticles in the environment? How can we promote responsible use of nanomedicine which protects both human health and the environment? And what are the specific ethics issues, such as justice, solidarity and autonomy, to be considered in this scientific domain?

10.4.1

Toxicology and Human Health

Safety. Safety issues of nanotechnology and nanomedicine have been addressed in several reports across the world, for instance, the SCHENIR report and the White Paper Nanotechnology risk governance published in June 2006 by the International Risk Governance Council. While using different approaches and methods, the above reports agree in stressing the lack of data on possible risks associated with nanomedicine and nanotechnology with regard to the human health and ecological consequences of nanoparticles accumulating in the environment. Risk assessment is conceived here not only as a technical element for the safe governance of nanotechnology but rather as a factor conducive to the protection of the human dignity and autonomy of the persons directly (medical applications) or indirectly (exposure to free nanoparticles) involved, as well as the protection of the environment. As far as nanomedicine is concerned, the risk assessment issues refer to possible health effects in terms of toxicity for the patients involved. For example, how do we check that, because of their greater capacity to pass through biological systems (for instance, crossing the blood-brain barrier and penetrating into the brain), that nanodevices designed for drugs delivery will not induce negative side-effects for the patients? Concerns have also been raised about the potential health risks for individuals other than patients due to the spread of free nanoparticles in the environment. The recycling of free and bound nanoparticles, and the possibility that such particles may pollute water, air and soil, raise issues about safety, and how the interests of the industry, competing for market shares, are to be balanced against other interests. Risk governance. Concerns are also raised by the difficulties of identifying, estimating and managing risks in an area where there are considerable uncertainties and knowledge gaps, and when the short-term and long-term risks may be different. Similar concerns are raised by benefit management. In this context, the temptation of exaggerating benefits (“hype”) should also be considered. The competition for research funds may, with the assistance of media and science fiction writers, contribute to creating nanomedical hype with regard to the curability of all diseases. In addition to more technical risk governance, a broader approach must be developed that is better able than present instruments to adjust to possible changes, in the environment, in societies, in market economics or in national policies.

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The Precautionary Principle. As stated in EGE Opinion No. 20, the Precautionary Principle does not necessitate impassable boundaries or bans. It is a general risk management tool, originally restricted to environmental matters. The basic constituents of the Precautionary Principle and the prerequisites for its application are the existence of a risk, the possibility of harm, and scientific uncertainty concerning the actual occurrence of this harm. Having referred to the Precautionary Principle the risk manager has to decide on precautionary actions, which are proportionate to the potential harm being mitigated and which do not attempt to create “zero risk” situations. The risk management actions should be aimed at identifying the “acceptable risk” threshold with regard to the values at stake.

10.4.2

Bioethical Questions

Protection of individuals. The protection offered by international declarations and guidelines applies to both health care and medical research; it includes the obligation to obtain free and informed consent from patients and participants in research and specifies the measures to be taken when patients and participants in research for various reasons (minors, mentally incapacitated, etc.) are unable to give consent. Informed consent. Informed consent requires the information to be understood. How is it possible to give information about future research possibilities in a rapidly developing research area and to make a realistic risk assessment in view of the many unknowns? In view of the knowledge gaps, and the complexity of the matter, concerning the long-term effects of nanomedical diagnostic and therapeutic tools, it may be difficult to provide adequate information concerning a proposed diagnosis, prevention and therapy needed for informed consent. Here the distinction between invasive and non-invasive procedures is very important, since they raise different concerns. Diagnostic complexity and increased personal responsibility. Nanomedicine offers new diagnostic possibilities, where the results will be available with unprecedented speed, magnitude, and precision at the molecular level. The results may be complex and difficult to interpret. New disease dispositions not known today may be discovered. However, the increased speed of the diagnosis and the implications for personal responsibility are hardly new in principle; these issues have been discussed extensively in the context of genetic testing. Third-party uses? What are the implications of nanomedicine for problems raised in cases where the information obtained by refined nanomedical diagnostic methods is used by third parties, in particular insurance companies and employers? Will these have access to the extensive diagnostic data that may be collected from citizens? If so, under what conditions? If there is a risk that the traditional system of insurance, based on solidarity and the principle of equal ignorance, can be undermined by the availability of new and more precise diagnostic tools based on nanotechnology, and we want to keep the

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traditional system, we need to think about how to limit the access to this more precise information. These issues have been discussed already e.g. in the EGE Opinion on Genetic testing in the workplace. Medical and non-medical uses: therapy and enhancement? Another issue that may raise concerns here is the fine line between medical and non-medical uses of nanomedical methods for diagnostic, therapeutic and preventive purposes. The borderline between medical and non-medical applications is not all that clear, but it is possible to give examples illustrating fairly clear cases of both. Concerns have been expressed that new nanomedical tools can be used not only to transgress the border between medical and non-medical uses but also to open the door to ethically problematic enhancements, for the reasons discussed in the Opinion on ICT implants. This raises questions not only for the state but also for the individual: how can we preserve the plurality of life-styles and avoid the transformation of the medical system into a mere service system for whatever desire individuals may have? Access from an individual perspective. Access to health-care and new medical technologies is often seen as a challenge for fair health-care systems. Individuals may struggle to gain access to nanomedical innovations, even taking on considerable financial costs. If they cannot afford new diagnostics, drugs, or therapies offered to them, they may feel left behind or even as second-class citizen.

10.4.3

Social Ethics

Social ethics addresses questions that are of economic, social and public concern and issues concerning governance and institutions. Economic issues. According to several indications nanotechnology is one of the most promising research areas for economic development, innovation and the goals of the Lisbon agenda. There are numerous companies involved in the invention, development and marketing of drugs, delivery systems, analytical tools and diagnostic systems based on, or using, nanomaterials. Investment in nanotechnology is very large throughout the world. The US National Science Foundation estimates that the nanotechnology market will be worth US$ 700 billion (around 537.7 billion euros) by 2008 and exceed one trillion dollars annually by 2015. Biomaterials and medical devices represent a fast emerging market that is estimated at about US$ 260 billion worldwide, including Europe’s share. Societal debates. Respect for different philosophical, moral or legal approaches and for diverse cultures is implicit in the ethical dimension of building a democratic Europe. This is relevant also for the moral controversies prompted by nanomedicine. Public participation is of vital concern in democratic states. But such participation also raises questions. In what way, and on what terms, can the public be an active partner in these debates? How can the development of nanomedicine and nanotechnology be tailored to the benefit of the public? How can we ensure that the public

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participates not only in discussions associated with nanotechnology and nanomedicine but in the overall design of research and development policy? This raises wider issues of trust and confidence building between the scientific community and the public, including the need to promote proper debate (in particular on uncertainties), and ultimately leads to questions about who draws the lines between what is allowed, acceptable, and what is not; and who overviews those who draw the lines. The role of the media in such a process has to be taken into account. Public participation and discourse about new and emerging technologies is important. What ways or means can be used to engage the general public about issues raised by the use of nanotechnological applications in medicine? Consensus conferences, public opinion surveys, and preparation of proper communication tools accessible to the general public (including new audiovisual tools) are all examples of possible actions to be taken to promote proper interaction between the public and the scientific and decision-making community (including industry, academia and NGOs). The participation of the public in all stages of the development of this innovative research sector is important not only for the public acceptance of nanomedicine and nanotechnology, but also for the adoption of a nanotechnology strategy where public concerns are approached and discussed from the beginning. Institutional/political issues. Nanomedicine is part of a process that can already be observed in other areas of research and technological development, demanding new models of governance, or structures to fashion the relations between society, the economy and research institutions. Depending on what policies on funding and, for example, patenting is chosen in this area, research and development in nanomedicine will take different paths. The concerns raised by nanomedicine for the relationship between the individual and the state include in particular the following: How can privacy be protected, when more and more information can be used for surveillance rather than only for medical reasons? Where can the line be drawn between useful data storage within the medical context and non-medical data storage? What strategies are implemented to protect the individual’s privacy in both contexts? The development and implementation of new technologies does not take place in a vacuum. What kind of prospective technology assessment will take place in the Member States and at European level? Which institutions are responsible for this work and on what assumptions are such technology assessments being carried out? Nanotechnologies have major applications in fields outside of medicine – but some of them will also have implications for individual and public health. This is true in particular for cosmetic applications but may also be relevant for military applications and agrifood. The implications cannot always be completely separated from medical concerns. Patenting of biomaterial for medical use has become an issue of ethical concern where and insofar as it may limit the provision of medical treatment on financial grounds. Patent law represents an attempt to strike a balance between several legitimate interests.

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European Patent law does not permit patenting of “methods for treatment of the human or animal body by surgery or therapy”. These issues will need to be subjected to ethical analyses, particularly when systems involving both tissues and nanomaterials are available for surgical procedures. Some have argued that there may be a conflict over patentability if a new product is both a pharmaceutical and a “diagnostic, therapeutic and surgical method” used for humans or animals. Research policies. As with other new technologies, concerns may be raised by the difficulties of meeting some of the requirements of the usual guidelines for clinical trials and research ethics in the nanomedicine area, in particular those concerning confidentiality of patient data and data protection generally. One of the objectives of the theme “The nano revolution” in the 6th Research and Development Framework Program (FP6) is “to develop intelligent materials for applications in sectors such as transport, energy, electronics and biomedicine representing a potential market of several billion Euros.” The 7th Research and Development Framework Program (FP7) calls for proposals on nanotechnology has been launched and it has been estimated that €300–400 million could be allocated to nanotechnology in 2007. Around 100 million euros per year is expected to be allocated to nanomedicine project proposals. There is no open access to military research. A new generation of weapons could be created with nanotechnologies that could have disastrous consequences for health and the environment. In any event, the use of these technologies in a military situation does not preclude the obligation to inform those exposed to these products. Attempts have been made to document the resources spent on military research involving applications of nanotechnologies, and to describe the direction of this research. This research, though not in focus in the present report, clearly raises concerns about its potential impact on safety and human welfare, which need to be addressed in a different context. Questions of Justice. According to the EU treaties, the role of the European Union and the Member States is to guarantee fair exchange and fair distribution of goods, equal participation and equal access to these goods. This is also in line with the provisions of the earlier European Convention for the protection of human rights and fundamental freedoms. To achieve these goals, injustice due to socio-economic or ethnic conditions, age or gender status should be corrected by taking “affirmative action” in order to improve the chances of participation and access. The development and introduction of nanomedical drugs, diagnostic methods and therapies are—like any new or emerging technology—to be assessed against this background. Anthropological questions: Changing the human condition. The overarching anthropological questions have to do with our view of ourselves and, in this context, the extent to which this view will be affected by the applications of nanotechnologies in medicine. Nano-scale implants and devices may have an impact on autonomy, integrity, self identity and freedom. In particular, what are the implications of the “man/machine” distinction, and in the perception of it, on a social level? How do our concepts of human beings change? What is the role of the media, literature and films (e.g. science fiction)?

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Such questions can be answered by social, cultural and ethical research in dialogue with biomedicine.

10.5

Opinion

Nanomedicine offers the possibility of new diagnostic, treatment and preventive methods that may open up promising areas of medicine.

10.5.1

Scope of the Opinion

The scope of this Opinion is ethical issues raised by nanomedicine in the sense indicated by the European Science Foundation definition quoted in the introduction. In this context, the Group will consider nanomedicine including a number of issues raised by nanotechnology insofar as they concern primarily health-related issues.

10.5.2

Fundamental Values and Rights

Nanomedicine, like many other domains, raises issues about protection of the fundamental rights enshrined in various European. These rights are rooted in the principle of human dignity and shed light on core European values, such as integrity, autonomy, privacy, equity, fairness, pluralism and solidarity. As stated in many European and international documents, the interests of science are legitimate and justified insofar as they are compatible with human dignity and human rights. New technologies are scrutinised with respect to the prospects of contributing to the improvement in human wellbeing they are aiming at, and with respect to possible threats to human wellbeing, be it at European or global level. As stated in the United Nations Millennium Development Goals, the Group considers that there is a moral duty to make affordable health care and biomedical technologies available to all those who need them on a fair and equitable basis,

10.5.3

Safety

In order to safeguard the core values mentioned above, including the precautionary principle, concern for safety with respect to nanomedical developments (and, in fact, nanotechnology in general) is of vital importance. Measures should be established to verify the safety of nanomedical products and to ensure that nanomedical devices are properly assessed with regard to public health. In particular, the uncertainties and knowledge gaps associated with new nanotechnology-based diagnostics, therapies and preventive measures should be

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identified. These uncertainties need to be characterised and measures have to be developed in order to reduce them as far as possible. Research needs to be carried out to develop new methods for risk management specific to individual nanotechnology applications. The Group proposes that relevant authorities should carry out a proper assessment of the risks and safety of nanomedicine. Such risk assessment should cover the whole life cycle of the products, from production to handling of waste. The same level of safety currently applied to medicine and medical devices should apply to nanomedical products. The Group considers it essential that reliable and cost-effective systems for toxicology screening of nanomaterials are developed (including instruments to quantify exposure and to characterise nanostructures in detail). The required animal testing should strictly follow the 3R principles: refinement, reduction, and replacement. Before starting in vivo testing, relevant data has to be gathered about the produced quantity, quantity and fate of uncontained nanostructures, and risk of exposure. Networking of relevant bodies, at national, European and international level should be encouraged to favour the proper implementation of safety measures and the adoption of common and validated standards. The Group also proposes that capacity building on how to address accidents and other unexpected situations should be encouraged and shared at European and international level. Publication of any results, whether positive or negative, which are relevant for safety must be part of the research contract.

10.5.4

Risk and Risk Assessment

The lack of knowledge and data regarding the toxicity of nanoparticles in humans and in the environment is a cause of concern. The existing methodologies for risk assessment are inadequate (see the SCENIHR report) and need to be adapted or new methods devised. The Group proposes that this should be considered a top priority for researchers and the relevant authorities and that data on adverse effects have to be communicated without delay to the public. The Group considers it necessary for appropriate safety research to be carried out and information provided to the public before medical devices and medicinal products derived from nanotechnologies are marketed. The Group proposes that initiatives be taken at national and European level to facilitate cooperation between institutions dealing with risk assessment. The Group considers it paramount that no nano-based products enter the market without risk assessment, thereby securing the safety with regard to users’ health. For example, cosmetics are of particular interest in relation to risk assessment as nanocosmetics penetrate the skin and may cross the blood-brain barrier. On this basis we recommend that consideration be given to the question whether specific measures should be implemented regarding nanocosmetics, including evaluating

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whether verification of the manufacturer’s risk assessment should be introduced in certain cases. The need for prospective technology assessment, including consideration of social effects In the rapidly developing fields of nanomedicine R&D, in addition to the usual retrospective risk assessment there is a need for prospective technology assessment at national and European level, not just for post factum evaluations. Prospective technology studies should be performed with special reference to the health impact of nanoparticles; this would also involve prospective technology assessment of possible adverse events that may derive from nanotechnology or nanomedicine. The Group proposes that such prospective technology assessment should consider issues of safety (agrifood and environment) and security (including dual-use, impacts of bioterrorism and military research). Social effects should also be addressed, e.g., how new nano-scale technologies applied in medicine will affect social, economic and institutional structures, with particular concern for justice (equal access and participation in decision-making) and fair distribution of goods. Furthermore, the Group suggests that the Commission should, inter alia, fund a study of the social effects of nanomedicine in the developing countries. Such research should also focus on macroeconomic trends, trade implications and possible international problems, and in particular examine the risk of creating a nano-divide which could widen the gap between the developed and developing countries.

10.5.5

Legal Issues

General issues. The Group does not propose new broad regulatory structures that specifically deal with nanomedicine at this point. Changes should primarily be made within existing structures. The focus should then be on the implementation of existing regulations. Monitoring is needed to ensure that regulatory systems exist to address all nanomedicinal products. Nanomedical products may combine different mechanisms of action, be they mechanical, chemical, pharmacological or immunological, for instance. The mechanism of action is a key factor in deciding whether a product should be regulated as a medicinal product or a medical device. The Group proposes that possible cases of nanomedicine applications where there might be overlap between regulations, which could create uncertainty as to which regulations should be applied, should be explored by the relevant authorities so that the existing regulations can be implemented in an unambiguous way. The Group proposes that networking between relevant authorities should be encouraged in order to deal in an optimal way with the problems outlined above, and that—if necessary—new specific implementing measures should be derived from the current regulations.

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The Group stresses that the protection offered by the Data Protection Directive has to be properly applied to the type of health data obtained and collected by nanobased DNA chips, nano-scale sensors and devices. Product liability legislation addresses many of the problems that may be associated with the new materials, but as the risks are not readily assessed and assessable, liability based on negligence and lack of knowledge becomes a serious ethical problem. This requires careful scrutiny and monitoring. Intellectual property rights. According to the current regulatory system for patenting, some exemptions are allowed with regard to the patentability of therapeutic and surgical procedures. The exemptions in the present patent system are based on a balance of interests whereby diagnosis, therapy and research should be available to patients without patents being a hindrance. This is likely to be blurred because the new nanomaterials may logically fall within more than one category. To protect the ethical position that has led to these exemptions it is important to ensure that patents in these new areas do not alter the current balance. There are risks of overly broad patents being granted that may hinder their therapeutic availability. This is also the case for nanomedicine. There is a need to look further into the balance between knowledge protection and information dissemination. Comparative research on the merits and shortcomings of different patent systems in various parts of the world is needed. Offering nanomedicine tests on the market. Medical tests of various kinds are currently offered for sale on the market, especially via Internet and other media, without medical prescription. In the near future such tests may also be based on applications of nanomedicine. The Group emphasises that the first concern is the scientific validation of these tests, including their clinical utility, and the accuracy, interpretation and communication of the results.

10.5.6

Information and Consent

The requirement for informed consent is of crucial importance in both medical research and health care. But both the lack of knowledge and the uncertainties that exist create problems for the attempts to provide adequate and understandable information and obtain consent that cannot exclusively be met by informed consent forms signed by patients. These problems should be considered in the context of developments that may contribute to a shift of responsibilities from the doctor to the patient. The Group considers it important that initiatives are taken on different levels to help ensure that decision-making is in the long-term interest of the concerned citizens themselves. Against this background, the Group encourages further efforts at national and European level to develop improved methods of providing information and obtaining consent e.g. through research projects under the ELSI (ethical, legal and social implications) program.

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Economics and Research Funding

Research funding affects research in nanomedicine, and emerging research in nanomedicine will affect research funding. Research funding in general raises ethical issues concerning the criteria used in priority setting. The overall goals of health-related research must be seen in the context of fair distribution and the overall goal of alleviation of the global health status. In this context, patenting and private gain derived from research funded by public money raises the issue of the fair sharing of burdens and benefits between taxpayers and companies, and should therefore be further explored. Against this background the Group proposes that further initiatives be taken at national and European level to clarify the ways in which public investments in this area will benefit the citizens of Europe. The initiatives should be conducive to European economic growth and social welfare but also contribute to the UN Millennium Development Goals.

10.5.8

Communication and Public Trust

Transparency is essential for public trust. This also holds for openness about uncertainties and knowledge gaps. Such transparency and openness should not be limited only to safety issues but should also extend to funding of research and development. The Group proposes that initiatives should be taken at national and European level to prepare surveys of public perception of the benefits and risks of the applications of nanotechnologies, with special reference to medical sectors. The Group also recommends that there should be an EU web site on ethics and nanomedicine which is updated regularly, and where citizens can find information and raise questions. The Group finally proposes that initiatives be taken to organise academic and public debates on problems and possibilities of present and near-future nanomedicine. The Group draws attention to the question of labelling of nanomedical products and recommends a thorough analysis of this issue by the Commission.

10.5.9

The Need for Interdisciplinary Research on the Ethical, Legal and Social Implications (ELSI) of Nanomedicine

The Group proposes that a considerable amount—up to 3%—of the budget invested in research in nanotechnology should be set aside for ELSI research. This is comparable to the budget allocated to ELSI research under FP5 (3% of the Life Science budget) and following the HUGO approach in the Human genome project (3% ELSI research). With respect to nanomedicine, cooperation between different academic disciplines, research centres, hospitals and other important players is required for progress in

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this area and should be promoted at the different levels of nanomedicine research and applications. The Group proposes that initiatives to support ELSI research should be taken at both national and European levels and that there should be an ELSI program within FP7 to promote research in the various fields of application mentioned in the ESF definition.

10.5.10

Ethical Deliberation on the Concept of Humanity, Human Rights, Social and Political Conflicts in Relation to Nanotechnology

In addition to technology-induced ELSI studies, the Group also suggests that initiatives be taken at European level to promote more research on philosophical, ethical and anthropological questions raised by recent developments in nanomedicine, looking into the broader questions of nanomedicine, among other things individual responsibility, including the shifts in the concept of the self, personal identity, societal goals and global health care. For this purpose, a dedicated European Network on Nanotechnology Ethics should be established and financed by the Commission under FP7.

10.5.11

Clinical Research Involving Nanomedical Applications

Nanomedicine, like other clinical research, is subject to the relevant EU legislation requiring trials to be approved by local or regional ethics committees. In addition to research on nanomedicine carried out at national level, a number of pan-European or international research trials are being performed; the Group therefore proposes that initiatives should be taken to enhance information exchange between research ethics committees in different Member States.

10.5.12

Medical and Non-Medical Uses

Medical and non-medical uses of new medical technologies have been an issue for several years. Nanomedicine is expected to broaden the overlap between medical and non-medical uses in specific ways. The distinction between therapeutic goals and enhancement goals may become less clear, if, for example, predisposition tests are available more easily and cheaply. Especially in the reproductive context of pre-implantation genetic diagnosis, the line between “negative” and “positive” selection may be blurred.

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In other areas, such as where the cosmetic industry deals with common allergies and the medical field addresses the same symptoms, the distinction may become even more difficult to draw than today. Future applications are difficult to foresee today. For example, it may become difficult to ensure that neurological stimulation of brain activity is restricted to therapeutic and diagnostic use. Therefore, appropriate monitoring and guidelines of the use of nanotechnology in this field should be implemented. The Group proposes that enhancement technologies should not be given priority. Health care concerns must be met first. The Group suggests that this concern should be explored both under the ELSI program and within a European network (involving ethicists and scientists) devoted to exploring the ethical aspects of different applications of nanotechnologies.

10.5.13

Sharing of Information and Establishing Databases

Relevant scientific and ELSI information related to nanomedicine is not always collected or publicly available. Against this background the Group underlines the importance of sharing of information in order to safeguard some of the values mentioned above (Sections 4.2 and 5.2). The Group therefore proposes that initiatives be taken at European level to establish databanks, not only on scientific aspects of nanomedicine, for instance the biodistribution of nanoparticles and results of toxicity studies, but also on ELSIrelated aspects of nanomedicine. Since research in the area of nanomedicine is undergoing rapid development, this text should be reconsidered and possibly revised in the light of scientific, legal and social developments within the next 5 years.

Chapter 11

Emerging Issues in Nanomedicine and Ethics Raj Bawa and Summer Johnson

11.1

Introduction

The high-risk, high-payoff global nanotechnology phenomenon is in full swing. Significant technologic advances intersecting engineering, biotechnology, medicine, physical sciences and information technology are spurring new directions in research, education, commercialization and technology transfer. Clearly, nanotechnology will continue along this interdisciplinary path. There is enormous excitement and expectation regarding nanotechnology’s potential impact on every aspect of society. Although early forecasts for commercialization efforts are encouraging, there are bottlenecks as well. Some formidable challenges include legal, environmental, safety, ethical and regulatory questions as well as emerging thickets of overlapping patent claims.1,2 In fact, patent systems are under great scrutiny and strain, with patent offices around the world continuing to struggle with evaluating the swarm of nanotech-related patent applications. Adding to this confusion is the fact that the US National Nanotechnology Initiative’s (NNI) widely-cited definition of nanotechnology is inaccurate and irrelevant, especially in reference to nanomedicine (see Section 11.2). Nevertheless, governments around the world are impressed by nanotechnology’s potential and are staking their claims

1 The emerging thicket of patent claims has primarily resulted from patent proliferation but also because of the continued issuance of surprisingly broad patents by the US Patent and Trademark Office (PTO). This is creating a chaotic, tangled patent landscape in various sectors of nanotechnology where the competing players are unsure as to the validity and enforceability of numerous issued patents. If this trend continues, it could stifle competition, limit access to some inventions and cause commercialization efforts in certain sectors of nanotechnology to simply grind to a halt. Therefore, if the full potential of the nanotechnology “revolution” is to be fully realized, certain reforms are urgently needed at the PTO to address problems ranging from poor patent quality and questionable examination practices to inadequate search capabilities, rising attrition, poor employee morale and a skyrocketing patent application backlog. All players involved in nanotechnology agree that a robust patent system is essential for stimulating the development of commercially viable products. 2 Bawa (2007a). Also see Drew L. Harris’s essay in this volume.

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by doling out billions of dollars, euros and yen for research.3 International rivalries are growing (Edwards, 2006; Van Lente, 2006). Political alliances are forming and battle lines are being drawn. Some of the greatest impacts of nanotechnology are taking place in the context of biology, biotechnology and medicine. This arena of nanotechnology is generally referred to as nanomedicine, and sometimes broadly called bionanotechnology (Vo-Dinh, 2007; Niemeyer and Mirkin, 2004). Already, there are a few nanomedicinerelated products on the market4 with numerous other potential applications under consideration and development (Vo-Dinh, 2007; Niemeyer and Mirkin, 2004; Kubik et al., 2005). But will nanomedicine provide valuable contributions to medicine and healthcare in the long run? It is hard to predict whether nanomedicine will deliver a variety of mostly incremental improvements of existing technologies or whether it will act as a catalyst for a vast technological and healthcare revolution. While exciting in its own right, clearly, the present day status of nanomedicine is only a milestone on the road to introducing truly innovative technologies. These will come about only over a period measured in decades, given the complexity of clinical trials and the hesitancy with which radical technologies are considered and adopted by the public. However, there are a few bright spots where development is progressing more rapidly. In this essay we will emphasize one such area of nanomedicine that is already producing significant results: drug delivery (Thassu et al., 2007). Drug delivery accounts for 78% of global sales in nanomedicine and 58% of patent filings worldwide (Wagner et al., 2006). For example, site-specific targeted drug delivery systems, with their potential to address unmet medical needs and personalized medicine (a result of advances in pharmacogenetics and pharmacogenomics) are on the horizon. Other more futuristic targeted drug delivery approaches involve “nanofactories” where biological molecules found in vivo can be converted into active biotherapeutics in response to a localized medical condition.

3

The passage of the twenty-first Century Nanotechnology Research and Development Act (Pub. L. No. 108-153) in 2003, which authorized 3.7 billion US dollars in federal funding from 2005 through 2008 for the support of nanotechnology R&D, is fueling the fervor over nanotechnology in the US. This legislation has resulted in the creation of R&D centers in academia and government. At present, there are over 50 institutes and centers dedicated to nanotechnology R&D. For example, the NSF has established the National Nanotechnology Infrastructure Network—composed of university sites that form an integrated, nationwide system of user facilities to support research and education in nanoscale science, engineering and technology. Similarly, there are currently numerous government agencies with R&D budgets dedicated to nanotechnology. The twenty-first Century Nanotechnology Research and Development Act addresses nanoethics at length. As a result, the NNI strategic plan identifies ethics as a key research area and divides “the responsible development of nanotechnology” into two classes, namely environmental, health and safety (EHS) implications and ethical, legal and other societal implications (ELSI). 4 The FDA has approved around a dozen nanotech-related products, both drugs (Rapamune, Doxil, Estrasorb, Amend, TriCor, Abraxane, Megase ES) and medical devices (NanOss, Vitoss, TiMesh).

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Numerous nanotechnology market reports are available, each varying widely in their statistics and conclusions.5 For example, the National Science Foundation (NSF) claims that by 2015 the annual global market for nano-related goods and services will top 1 trillion US dollars. On the other hand, Lux Research, Inc. predicts that by 2014, 2.6 trillion US dollars in global manufactured goods may incorporate nanotechnology (about 15% of total output) (Lux Research, 2004). It has been reported that governments, corporations and venture capitalists in 2006 spent 12.4 billion US dollars on nanotechnology R&D globally, up 13% from 2005 (Reisch, 2007). In fact, in the past few years, global spending on nanotech products has far surpassed that spent on nanotechnology R&D. In 2006, global government spending grew to 6.4 billion US dollars, up 19% from 2005. One widely-cited market report noted that in 2005, nanotechnology was incorporated into more than 30 billion US dollars worth of manufactured goods (Lux Research, 2006). A recent study claims that presently there are around 500 nanotech-based consumer products in the marketplace (Woodrow Wilson International Center for Scholars, 2007). Once again, it should be emphasized that most such market reports rely on the flawed NNI definition of nanotechnology to draw their conclusions (see Section 11.2). Yet, despite all of this research and development in nanotechnology, federal funding (through the NNI) related to the research and educational programs on nanoethics have clearly lagged behind (Cameron, 2006; Berube, 2006; National Nanotechnology Initiative, 2007). Some ethical issues pertaining to nanomedicine have been recently addressed by a few authors, including those who have articulated ways in which nanomedicine might change the health care system (Best and Khushf, 2006) and the needs in terms of policy, funding and scholarship that would ensure the ethical advance of nanomedicine (Johnson and McGee, 2007). It is critical that ethical, social and regulatory aspects of nanomedicine be proactively addressed so as to minimize public backlash similar to that seen with genetically-modified foods in Europe (Mills and Fleddermann, 2005). The public and other stakeholders should be properly educated regarding the benefits as well as the risks of nanomedicines. In this regard, taking an integrated approach to implications and commercial applications is essential for greater public acceptance and support. This essay will outline many of the current trends, emerging issues and ethical questions related to nanomedicine. First, clarification about the definition of nanotechnology and nanomedicine will help set the stage for discussions about the nanomedicine industry, the ethical issues at stake with these technologies and an assessment of the future for nanomedicine.

5

In our view, the data reflected in these reports may not always be completely reliable. Poor assumptions often underlie the analyses, rendering the results highly questionable or largely irrelevant. Therefore, these reports should be taken as indicating general trends rather than reflecting solid figures.

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Current Definitions of Nanotechnology and Nanomedicine

One of the problems facing nanotechnology is the confusion, hype and disagreement among experts about its definition (Bawa, 2006). Nanotechnology is an umbrella term used to define the products, processes and properties at the nano/micro scale that have resulted from the convergence of the physical, chemical and life sciences. One of the most quoted definitions of nanotechnology is the definition used by the NNI (National Nanotechnology Initiative, no date): “[n]anotechnology is the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications.” Clearly, this definition excludes numerous devices and materials of micrometer dimensions, a scale that is included within the definition of nanotechnology by many nanoscientists (Bawa, 2004; Bawa et al., 2006; Bawa, 2007a). Moreover, nanotechnology and nanoproducts are not new. For example, rubber tires have been reinforced for more than a century via incorporation of carbon nanoparticles (“high-tech soot nanoparticles”). Numerous nanoparticles exist in nature (e.g., volcanic ash, viruses, biomolecules, etc.) or are the result of human activity (e.g., diesel exhaust particles and smoke). Given this confusion, a more practical definition of nanotechnology that is unconstrained by any arbitrary size limitation has been recently proposed (Bawa et al., 2005): The design, characterization, production, and application of structures, devices, and systems by controlled manipulation of size and shape at the nanometer scale (atomic, molecular, and macromolecular scale) that produces structures, devices, and systems with at least one novel/superior characteristic or property.

Naturally, disagreements over the definition of nanotechnology carry over to the definition of nanomedicine. At present, there is no uniform, internationally accepted definition for nanomedicine either. Hence, the size limitation imposed in NNI’s definition should be dropped, especially when it is applied to nanomedicine. Also, an internationally-acceptable definition and nomenclature of nanotechnology should be promptly developed. Defining nanomedicine or nanotechnologies applied to medicine also has significant ethical implications. Definitions help determine the scope of ethical inquiry and define the common language about which persons can engage in ethical discourse. Definitional murkiness for both nanotechnology and nanomedicine, then, begs the question from the ethical perspective as to whether nanomedicine presents any new challenges for ethicists or whether nanotechnologies applied to health and healthcare simply raise old issues in a new light. If, for example, nanotechnologies applied to medicine really are not something new at all, it would seem reasonable to conclude that it would not present any new or unique ethical issues to be discussed. In fact, some do argue that there is nothing ethically novel about nanotechnology (Litton, 2007; Lewenstein, 2005; Grunwald, 2005). These observers dismiss that nanotechnology (and nanomedicine) will generate truly novel ethical and social issues. Instead, they feel that nanotechnologies simply raise the same standard issues of research ethics,

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privacy and confidentiality at stake in all other kinds of medical research and development. While this may be true to a large extent, nanoethics may be viewed as a convergence of many areas of ethics—it adds a new dimension to current ethical debates (Allhoff and Lin, 2006). It is our view that while many of the ethical issues in nanomedicine may be recurring themes in bioethics, there may be ways in which nanomedicine sheds new light on old issues or asks the old ethical questions in slightly new ways. For example, the highly interdisciplinary nature of nanomedicine means that engineers, biologists, physicists and others will be working on developing and implementing these technologies. The ethical codes and frameworks (and the emphases on certain ethical values such as efficiency or utility) differ slightly from profession to profession. This means that the ethics of nanomedicine may have a slightly different set of core moral values or considerations than traditional medical applications due to the influence of other ethical frameworks and perspectives on the research and development of these interventions.

11.3

The Pharmaceutical Industry’s Role in Nanomedicine

The pharmaceutical industry depends upon innovation, both for profitability and for developing superior therapies. In today’s global economy, the industry faces enormous pressure to deliver high-quality products to the consumer while maintaining profitability. US drug companies must constantly reassess how to improve the success rate of new chemicals entities (NCEs) while reducing research and development (R&D) costs as well as cycle time for producing new drugs, especially new blockbusters. In fact, the cost of developing and launching a new drug to the market, although widely variable (DiMasi et al., 2003; Adams and Brantner, 2006), may be upwards of 800 million US dollars. Typically, the drug appears on the market some 10 to 15 years after discovery (Reuters, 1999). Furthermore, for every 8,000 compounds screened for potential drug development, only one makes it to final clinical use (Breen, 2007) and only one out of five lead compounds makes it to final clinical use (Erickson, 2006). Annual R&D investment by drug companies has risen from one billion US dollars in 1975 to 40 billion in 2003, while NCE approvals have essentially remained flat—between 20–30 drugs per year (Sussman and Kelly, 2003). In fact, for the past few years, NCEs accounted for only 25% of products approved, with the majority of approvals being reformulations or combinations of already approved agents (Breen, 2007). While the cost of drug R&D continues to rise, only 30% of drugs are able to recover their R&D costs. The weakened product pipeline issue is an international problem as the decreasing numbers of new drugs approved by the US Food and Drug Administration (FDA) and foreign drug agencies continues to haunt the drug industry. For example, FDA approvals have fallen by half since 1996, with only 20 approvals in 2005. The drug industry is currently facing other related hurdles and pressures as well. One of the most significant issues relates to an increase in the global generics’ share

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of the prescription drug market. International competition from low-cost centers like India, China and Eastern Europe (especially generic competition, clinical trials and manufacturing), forced or voluntary withdrawal of several drugs, and expiration of patents on blockbusters are other issues that are impacting big pharma. Nanotechnology not only offers the potential to address some of these challenging issues but it can also provide significant value to pharma portfolios. Nanotechnology can enhance the drug discovery process via miniaturization, automation, speed and the reliability of assays. It will also result in reducing the cost of drug discovery, design and development and will result in the faster introduction of new cost-effective products to the market. For example, nanotechnology can be applied to current microarray technologies, exponentially increasing the hit rate for promising compounds that can be screened for each target in the pipeline. Inexpensive and higher throughput DNA sequencers based on nanotechnology can reduce the time for both drug discovery and diagnostics. It is clear that nanotechnology-related advances represent a great opportunity for the drug industry as a whole. In fact, the nano-pharma market is expected to significantly grow in the coming years. Analysts project that by 2014, the market for pharmaceutical applications of nanotechnology will be around 18 billion US dollars per year (Hunt, 2004). According to a 2007 report, the US demand for nanotechnology-related medical products (nanomedicines, nanodiagnostics, nanodevices and nanotech-based medical supplies) will increase over 17% per year to 53 billion US dollars in 2011 and $110 billion in 2016 (The Freedonia Group, Inc. Report, 2007). This report predicts that the greatest short-term impact of nanomedicine will be in therapies and diagnostics for cancer6 and central nervous system disorders. In light of all this pressure for profitability, speed and efficacy, some raise the possibility of questionable ethical and safety practices among nanomedicine companies. They worry that the hype will obscure the ethical issues and larger social, legal and environmental implications of their research. Therefore, researchers, policymakers and businesses must take the time to consider the upstream and downstream ethical implications of their research agendas. The key time to think about ethical questions is not after the technology has been developed and adopted, but before R&D efforts even begin. Ethical considerations about priority setting and whether or not a technology should be used by society must take place before the technology is developed. Once the product is on the market, it is difficult to put the genie back in the bottle, particularly if market forces dictate otherwise. The safety and risk issues of nanomedicine should be extensively assessed at the preclinical phase (in vivo animal experiments and ex vivo laboratory analyses) and clinical testing phase (human subject exposure). The risks of nanomaterials depend upon numerous factors, including size, shape, route of exposure and chemical reactivity of the components (see Section 11.5). Since nanomaterials are a poorly-studied,

6 The National Cancer Institute (NCI) is funding a multi-million dollar cancer initiative to create centers of cancer nanotechnology. Several nanomedicine-based treatments for cancer are either approved or are pending approval by the FDA. Also see, Service, 2005; Gordon and Hall,2005.

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chemically diverse class of compounds, they may behave differently or exhibit unpredictable toxicity in the host. Therefore, it is ethically essential that researchers inform potential research subjects in clinical trials of all details pertaining to the study (i.e., purpose, experiments, risks/benefits, alternatives, confidentiality protection, etc.) (Donaldson, 2006). Furthermore, when the clinical trials involve novel nanomaterials whose physiochemical properties are poorly studied, potential research subjects should be informed that unpredictable risks may arise during the trials (Resnik and Tinkle, 2007). It is critical that the research risks be clearly communicated to the subjects.7 In fact, to gain and maintain public support for nanomedicine generally, an honest and open discussion with the public regarding the ethical and social issues surrounding nanomedicine should be promptly undertaken (Mills and Fleddermann, 2005).

11.4

The Promise of Nanomedicine

Nanotechnology promises to transform most industries and will have a particularly profound impact on health care and medicine. The future impact of nanomedicine on society could be huge. Specifically, nanomedicine will drastically improve the patient’s quality of life, reduce societal and economic costs associated with healthcare, offer early detection of pathological conditions, reduce the severity of therapy and result in improved clinical outcome for the patient. We expect that, in the coming years, significant research will be undertaken in various areas of nanomedicine— generating both evolutionary and revolutionary products (Bawa, 2007b). Nanomedicine is, in a broad sense, the application of nanoscale technologies to the practice of medicine, namely for diagnosis, prevention and treatment of disease and to gain an increased understanding of complex underlying disease mechanisms. The creation of nanodevices such as nanobots capable of performing real-time therapeutic functions in vivo is one eventual goal here. Advances in delivering nanotherapies, miniaturization of analytic tools, improved computational and memory capabilities and developments in remote communications will be integrated. These efforts will cross new frontiers to the understanding and practice of medicine. The ultimate goal is obviously comprehensive monitoring, repair and improvement of all human biologic systems—an enhanced quality of life. Yet, nanomedicine is not a single class of medical interventions that easily can be analyzed from an ethical perspective. Nanomedicine will likely resurrect old questions about human enhancement, human dignity and justice that have been asked many times before in the context of pharmaceutics research, cloning or gene

7 To be considered ethically sound, all biomedical research on human subjects must have scientific merit. Furthermore, certain cross-disciplinary guiding ethical principles must be followed: respect for free and informed consent; respect for individual privacy; respect for vulnerable persons; respect for justice; balancing the risks and benefits; minimizing harm; and maximizing benefit.

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therapy. For example, nanomedicine raises fundamental questions like what it is to be human, how human disease is defined, and how treating disease is approached. Just as with genetics and biotechnology, physicians will have to reconceptualize how they think about the diseases they treat, the means they have to treat them, and the meaning of the phrase, “do no harm.” Because it is difficult to exactly predict technology trends or innovations in nanomedicine, it is impractical for ethicists to envision or address all possible scenarios or issues that might arise out of nanomedicine in the future (Bawa and Johnson, in press). Yet, on the basis of other kinds of biomedical technologies that have affected health care, it is possible to conjecture what some of the perennial ethical issues and novel ethical problems for nanomedicine will be. Broadly speaking, nanomedicine interventions fall into two major categories: therapeutic nanomedicine and diagnostic nanomedicine. Each of these technologies and their applications have particular, and in some cases, unique ethical implications for their development, use and accessibility. Two main types of nanomedicine products that are currently in clinical trials pertain to drug delivery and diagnostics. We will address ethical issues in these two broad categories of nanomedicine in Sections 11.5 and 11.6.

11.5 11.5.1

Nanomedicine and Drug Delivery Market Trends

Nanomedicine is already impacting the drug delivery arena. Drug companies now recognize that drug delivery systems (DDS) need to be an integral part of their R&D operations at an early stage. According to one market report, nanotech-enabled drug delivery systems will generate over 1.7 billion US dollars in 2009 and over 4.8 billion US dollars in 2012 (NanoMarkets Report, no date). This report projects that the global drug delivery products and services market will surpass 67 billion US dollars in 2009. Another report places the nanotechnology-enabled drug delivery market for 2005 at about 1.25 billion US dollars, growing to 5.25 billion US dollars by 2010 and 14 billion US dollars by 2015 (Jain and Jain, 2006).

11.5.2

Formulating Nanomedicines

Nanodrugs are a heterogeneous group of drugs that generally offer unique properties because of their nanoscale dimensions (nanometer to micron) or due to enclosure/ entrapment of therapeutic agents within their polymer matrices (nanoencapsulation). They are diverse both in their shape, size and chemical composition. Many of the properties of nanomaterials are fundamentally different from those of their macroscopic/ bulk analogues. Therefore, nanodrugs, particularly, nanoparticulate drugs, often offer

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an advantage as compared to their bulk counterparts due to one or more of the following parameters or properties: solubility (high surface/bulk ratio); bioavailability; half life; stability/shelf life; ability to penetrate biological barriers/ membranes; toxicity/side effects/safety/patience compliance; patient fasted/fed variability; delivery dose; catalytic properties; imaging; multifunctionality; site specific delivery/targeting; pharmacokinetics/timed release/controlled release; surface structure/chemistry/modification; drug distribution; and physical properties (color, transparency, magnetism, quantum effects). There are numerous polymeric nanoscale materials (i.e., nanomaterials) of varying architectures that can act as platforms for active agents, including pharmaceuticals. It is important to note that these structures are sometimes loosely classified as nanoparticles. Furthermore, there is no universal convention or nomenclature that classifies nanoparticles as perfect spherical structures with nanoscale dimensions. Some of the common shapes include spheres (hollow, porous or solid), tubules, and tree-like branched macromolecules. They are synthesized by various methods, such as self-assembly, vapor or electrostatic deposition, aggregation, nano-manipulation, imprinting, etc. Similarly, the polymers that constitute nanomaterials are diverse; they are selected for properties such as biodegradability, biocompatibility, conjugation, complexation or encapsulation properties and their ability to be functionalized. The specific protocol for synthesis is dictated by the specific drug used and the desired delivery route.

11.5.3

Ethical Issues

One of the first areas where ethical considerations in nanodrug delivery and therapy arise is in the actual selection of the nanomaterial itself. As discussed above, a wide range of materials exist that can be used to deliver active agents to various parts of the human body. However, the nature of these materials (e.g., whether they are natural or synthetic, soluble or insoluble, hydrophobic or hydrophilic) has significant implications for the risks associated with using them for delivery of active agents to affected cells or tissues. In fact, assessing the safety of nanomaterials is particularly difficult, given their diverse chemical make-up. The only common property of nanomaterials is their nanoscale size; they are not a class of compounds. The size, surface charge, shape and chemistry of nanomaterials generally dictate their chemical and physical properties. These properties are what make them highly effective and desirable, but they can also make them particularly risky. For example, the ability of nanoparticles to unintentionally cross the blood-brain barrier, trigger a severe immune response, accumulate in certain tissues and cause toxicity, or enter cell nuclei and trigger an undesirable gene response raises significant questions about risk assessment that may not always be observed with conventional pharmaceuticals. Also, nanoparticle behavior is often unpredictable; they may behave differently in vivo as compared to in vitro (Oberdörster et al., 2005). For example, within an organism nanoparticles (or nanomaterials) may disintegrate into smaller particles

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that are toxic. Conversely, they may aggregate in vivo into larger clusters that are hazardous. Unpredictability is the underlying issue here. This makes the risk-benefit calculus of nanomedicines (compared to conventional pharmaceuticals) particularly challenging. Therefore, it is ethically desirable that extensive short- and long-term studies be undertaken to determine whether nanomedicines will be more effective and safe for humans when compared to conventional drugs. As we rapidly move forward into the era of nano-based therapies, nanomedicines will have to be tested in clinical trials (also see Section 11.3). As with any clinical trial, there are concerns about the risk versus the benefit for human research subjects during the trial. However, it is the novel nature of most nanomaterial-based therapies and their unpredictability in clinical trials that is especially alarming to some. First, the complexity of nanotechnologies may make informed consent for human subjects’ research increasingly complicated and may cause problems with comprehension and understanding for those wishing to participate in such trials. Second, the long-term effects of using nanomedicines and nanotherapies are largely unknown. This will continue to be the case for many years. If it is suspected that this may be the case, there is a moral responsibility on the part of R&D scientists conducting the clinical trial to allow for long-term follow-up (see below) with patients receiving a nanomedicine. More importantly, these patients must be informed at the onset of the clinical trial that there may be potential and unpredictable long-term risks or consequences. Furthermore, the FDA must review its preexisting authority (regulatory and enforcement) with respect to nanotechnology and ensure that new drugs and new medical devices that incorporate nanomaterials provide adequate protection to the public. Comprehensive changes may indeed be necessary at the FDA to address the novel health and safety risks that numerous nanomaterials pose. For example, if needed, the FDA should mandate certain nanomedicine companies to conduct longterm studies on their products following their introduction into the marketplace. Currently, such long-term follow-up assessment of drugs (i.e., post-marketing surveillance or Phase IV studies) is poorly practiced because it is not legally required under current laws. It is clearly the weakest link in the entire US drug safety system (Strom, 2006). However, introducing new regulations should be done with care. Like with any regulation relating to drugs and the FDA, the public and political interest for regulations needs to be carefully balanced with the interests of scientists and businesses for uninhibited science and technological efforts. Overregulating nanomedicine will have a chilling effect on R&D, commercialization efforts and fair access of nanomedicines to the public. The development of novel nano-based therapies also raises many of the perennial issues related to justice and fair access. It is likely that in the short-term, nano-based therapies will be quite expensive when they are first introduced into the market because they will be protected via patents. Obviously, the prices of these novel therapies will gradually decline as competitors develop products, or when the original patents on the novel technologies expire and generics arrive in the market. However, in the short term, due to patent monopolies, most of these therapies may be out of reach for many people of lower socioeconomic status or those who reside in developing

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countries. Nano-based therapies also have the potential to further marginalize those individuals in society that are perceived as disabled. In the future, a possible scenario could exist where only the rich have access to treatments while the poor are denied even the knowledge of their diseases. Nanomedicine could exacerbate these problems. For these people, the benefits of nanomedicine may be largely out of reach. National and international inequalities could also worsen. Therefore, the question of how to fairly distribute the benefits of nanomedicine to all segments of society – including thinking about ways to make these interventions more affordable, more easily produced and as safe as possible for all – are of great ethical consideration. In recent years, patents have become the subject of much debate and controversy. In fact, there are plenty of anti-patent players in the field who feel that patent laws (and most international treaties) are unfairly providing an economic advantage to some over others. It has even been suggested that patent laws and intellectual property (IP) are the products of a new form of western colonialism designed to deny the developing world access to common goods. Issues such as biopiracy, IP theft and greed on the part of multinationals have been proffered as reasons for the unavailability of essential drugs to the poorest and neediest people in the world. Not surprisingly, those in the developing world support patent protection but prefer a regime that suits their own national interests. In this regard, they highlight the fact that, although western drug companies continue to cite the need to reward innovation as a justification for stronger patent laws or patent enforcement, the industry continues to spend more on reformulating pre-existing drugs and on expensive litigation to protect their current patent portfolios than to innovate (Saini, 2007). Future struggles over patents on the international stage are almost certain to focus on drug patents where multinational drug patents are revoked or challenged (Tremblay, 2007). In our view, a multinational drug company’s patent rights and providing access to affordable drugs to the developing world are inter-related; they should never be considered mutually exclusive. Therefore, in order to promote global justice concerning access to novel nano-based therapies, national and international patent laws and intellectual property policies (especially those established by the industrialized nations) should ensure that manufacturers do not have excessive control over the market, and that fair trade agreements and fair pricing schemes (e.g., a stratified pricing program) are developed and practiced (Resnik, 2004). The use of certain kinds of nanomaterials, nanomedicines or nanodevices also raises fundamental questions about human enhancement and human nature (President’s Council on Bioethics, 2003). Although many of these questions about human enhancement engage in futuristic scenarios, it is important to consider the fundamental philosophical questions about how many implantable nanodevices it would take for a person to no longer be considered a human being. Some biomedical applications of nanotechnology will also blur the conventional boundary between “living” and “non-living.” In this context, issues relating to unfair competition, socio-economic inequality, discrimination, and bias will certainly arise and need to be addressed. Moreover, is it morally acceptable to us as a society that athletes or military personnel have significant parts of their bodies altered to enhance performance

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in competitive or combat situations? In these instances, the use of such “technologies” is likely to have strong moral justification. However, when we start moving closer to personalized medicine, treatments for the healthy or intervention for those without disease, the moral justification for using such “enhancements” becomes much less clear. In view of this, a broader question pertaining to enhancement arises: when is a medical procedure/intervention/treatment regarded as a therapy and when is it considered an enhancement? A little analysis, however, reveals these distinctions to be unavailing because both enhancement and therapy are based on the relative concept of “normal.” In fact, most novel medical technologies that are employed for diagnosis, prevention or treatment of diseases can also be used to enhance the function of the human body or mind.

11.6

Nanodiagnostics and Ethical Implications

Many of the interventions, technologies, DDS and nanomaterials described above also have applications for the early detection and diagnosis of disease. For example, quantum dots have been used as an alternative to conventional dyes as contrast agents due to their high excitability and ability to emit light more brightly and over longer periods of time (Alivisatos, 2002). In vivo disease detection and monitoring using micro-electromechanical systems (MEMS) also appears to be promising applications for creating “lab-on-a-chip” devices to detect cells, fluids or even molecules that predict or indicate disease states (Craighead, 2006). Lab-on-a-chip devices involve a combination of nanotechnology and microfluidics where multiple sample mixing, transport, integration, detection and data processing are all conducted on a single chip. The use of MEMS chips and other devices for the purpose of diagnosing or monitoring healthy or diseased states is likely to raise important questions about health information systems, privacy and confidentiality in our healthcare system. Currently, the use of devices that could provide real-time monitoring of blood glucose levels or other biometrics sound plausible and potentially beneficial to those with chronic illnesses like diabetes. In a nanoworld, where diagnostics assays and devices of much higher selectivity and sensitivity will be fabricated, we might have to reconsider as to what it means to be a “healthy person” versus a “person who has a disease.” Does disease imply the ability to detect an individual defective cell, subtle molecular alterations in genes or even minor “abnormal” changes in blood chemistry? What is “abnormal” and what is “normal” in this context? The answers to these questions are difficult to answer at this stage because at this point no one knows exactly how to define, diagnose or detect diseases at ultrahigh levels of sensitivity. It is important to remember that the development of such diagnostic technologies may also require reconceptualizing our understanding of certain diseases. All of this will have a significant impact on health care professionals and patients.

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It has been postulated that by 2016 the clinician or healthcare worker will be capable of scanning one’s entire genome within minutes (Goldstein, 2005). Many ethical dilemmas are posed by knowledge of risk factors that are known only in probabilistic terms. Also, how will individuals be able to afford vastly expensive new medical procedures predicated on nanomedicine’s diagnostic and therapeutic potentials? It is difficult to make predictions, especially about the future of technological innovations. Therefore, nanomedicine diagnostics should not move into the market place without extensive clinical evaluation, risk assessment and long-term monitoring. This long lag time will provide the critical breathing room necessary for society to sort out the complex social and political issues flowing from the potentially “disruptive” features of nanomedicine diagnostics. Some have further warned that the volume of data pouring out of the nanomedicine diagnostic spigot may eventually overwhelm the ability of health information systems to evaluate it—making effective treatment impossible (Goldstein, 2005). This situation could certainly arise if the amount of clinical information generated is too vast and no method of triaging exists. In this scenario, physicians would be forced to wade through haystacks of irrelevancies in search of a few precious needles of clinical wisdom. Yet today, although physicians are often overwhelmed by clinical data (the vast amount of which are of marginal significance) they are nonetheless able to put aside unsupportive data and make accurate diagnoses. Clearly, incisive diagnostics could eliminate fruitless treatments and save the healthcare system vast resources. However, currently, most countries do not have a healthcare information system ready to handle the significant amounts of data that would be generated by nanomedicine diagnostic devices described above. Moreover, such devices would have to ensure that the information could not be intercepted by third parties. If we are going to begin collecting significant amounts of real-time health information using nanotechnologies, we must ensure that such information does not wind up being used (or misused) by health insurance companies or employers. Obviously, without specific safeguards in place, it could be highly detrimental to individuals with nanodevices (e.g., implanted nanosensors)—the harm of such devices will outweigh their potential benefits. A larger, more philosophical question raised by these nanomedicine diagnostics is the effect of real-time monitoring and/or early disease diagnosis on perceptions and understanding of health states. The ability to detect a single cancerous cell or only slightly elevated biometrics could have profound effects upon how individuals think about the status of their health and bodies. A heightened awareness of one’s health status could result in increased anxiety and fear about illness and actually cause psychosocial harms. Such information could also have profound effects upon behaviors affecting health (e.g., information about precisely what effect eating a 12-ounce steak has on blood cholesterol levels). Such an implication might be beneficial for some but could result in increased anxiety for others. This example raises a larger question: how much medical information is really beneficial to human health and well being? Nanomedicine will allow us to understand down to the atomic and single-cell level how our bodies are performing at any given

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moment. For some, this information could be helpful, empowering or enlightening and may enhance human health. For others, it is likely that such information could result in fear, anxiety and other mental health issues. Therefore, a delicate balance may need to be established here between the information processed/disseminated versus the benefit to society and individual health. This issue is likely to be a significant consideration for ethicists when assessing nanodiagnostics.

11.7

Concluding Remarks and the Future of Nanomedicine

Nanomedicine is a global business enterprise impacting universities, startups and boardrooms of big pharma alike. Industry and governments are clearly beginning to envision nanomedicine’s enormous potential. As long as government expenditure encourages facile technology transfer to the private sector, nanomedicine will eventually blossom as a source for corporate investment and revenue. Will nanomedicine transform our industrial base and have a dramatic impact on healthcare and our long-term quality of life? As envisioned here, applications of nanomedicine hold out a wealth of promise, given the many applications in drug delivery, diagnostics, detection, discovery, sensing and imaging. However, nanomedicine has been so enthusiastically promoted that the hype and expectations may far exceed reality, especially given the immense lag time between R&D and the appearance of commercially-viable products in the marketplace. Therefore, for nanomedicine to truly become a global megatrend, this hype must be separated from reality. It is also important to ensure that advances in medical care due to nanotechnology do not come at the expense of fairness, safety or basic understanding of what it means to be a healthy human being. The changes that nanomedicine is likely to bring about should be addressed and managed through strategic planning and ethical analysis. As scientific advances occur, the responsible development of nanomedicine requires that societal and ethical concerns be addressed. Even if many of these issues are not new or unique, it will still be essential to address these questions and arrive upon justifiable answers for them. Initially, some of the important ethical concerns will continue to focus on risk assessment and environmental management. Later on, classic ethical questions regarding social justice, privacy, confidentiality, long-term risks versus benefits and human enhancement are certain to arise. Eventually, novel ethical issues and unforeseen dilemmas will emerge as the field advances further and intercepts other areas of biomedical research, including genomics, personalized medicine, bioinformatics and neurobiology. There is also great concern today over the environmental issues, health risks and safety of many nanotechnologies and nanomedicines. There have been dire warnings concerning the risks inherent in some of these technologies. Regulatory agencies like the FDA are struggling to formulate an appropriate set of guidelines, a difficult task given the current level of uncertainty. We argue that time to consolidate these discoveries is essential. The history of science is replete with technological innovations

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that moved from the laboratory to the marketplace, only to precipitate grievous consequences once they were widely disseminated. Classic examples include pesticides, atmospheric CO2, atmospheric fluorocarbons, radioisotopes and thalidomide. Today, the stakes are much higher. Repercussions (real and imagined) may be rapidly forthcoming and blame will be assigned through the courts, which is generally not the most effective route to the truth. However, current fears about self-replicating nanobots, the potential toxic effects of nanoparticles and the calls for strict regulatory oversight or a nanotech moratorium, will eventually give way to intelligent public dialogue on the realistic impact of nanotechnology and nanomedicine. Government and industry must pay greater attention to emerging public concerns of nanomedicine (environmental, ethical, societal and health issues) in order to prevent any public backlash. In the end, acceptance of nanomedicine will largely depend upon trust in government oversight of ethically sound R&D and commercialization. Only then will the public be more engaged in and aware of nanomedicine, leading to its wider adoption in society.

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Edwards, S.A. 2006. The Nanotech Pioneers: Where Are They Taking US? Weinheim, Germany: Wiley-VCH. Erickson, J. 2006. Translation Research and Drug Development. Science 312.5776: 997. The Freedonia Group, Inc. Report. 2007. Nanotechnology in Healthcare. Cleveland, OH. Goldstein, A.H. 2005. Nanomedicine’s Brave New World, 28 November. http://www.salon.com/ tech/feature/2005/11/28/nanomedicine/print.html. Cited 1 June 2007. Gordon, E.M. and F.L. Hall. 2005. Nanotechnology Blooms, at last. Oncology Reports 13: 1003–1007. Grunwald, A. 2005. Nanotechnology—a new field of ethical inquiry? Science and Engineering Ethics 11: 187–201. Hunt, W.H. 2004. Nanomaterials: Nomenclature, novelty, and necessity. Journal of Materials (October). http://www.tms.org/pubs/journals/JOM/0410/Hunt-0410.html. Cited 1 June 2006. Jain, K.K. and V.J. 2006. Impact of nanotechnology on healthcare—Applications in cell therapy and tissue engineering. Nanotechnology Law & Business 3.4: 411–418. Johnson, S. and G. McGee. 2007. Nanotechnologies in healthcare: A needs assessment regarding ethics and policy in nanomedicine. Harvard Health Policy Review 8.1: 46–54. Kubik, T et al. 2005. Nanotechnology on duty in medical applications. Current Pharmaceutical Biotechnology 6: 17–33. Lewenstein, B.V. 2005. What counts as a ‘social and ethical issue’ in nanotechnology? Hyle International Journal for Philosophy of Chemistry 5: 5–18. Litton, P. 2007. Nanoethics: What’s new? Hastings Center Report 37: 22–25. Lux Research. 2004. Sizing Nanotechnology’s Value Chain. New York: Lux Research, Inc. Lux Research. 2006. The Nanotech Report, 4th ed. New York: Lux Research, Inc. Mills, K. and C. Fleddermann. 2005. Getting the best from nanotechnology: Approaching social and ethical issues openly and proactively. IEEE Technology and Society Magazine 24.4: 18–26. NanoMarkets Report. No Date. Nano-enabled Drug Delivery Market to Pass $1.7 Billion in 2009. http://www.nanotech-now.com/news.cgi?story_id=08590. Cited 1 June 2007. National Nanotechnology Initiative. 2007. Supplement to the President’s FY 2007 budget. http:// www.nano.gov/NNI_07Budget.pdf. Cited 1 June 2007. National Nanotechnology Initiative. No date. What is Nanotechnology? http://www.nano.gov/ html/facts/whatIsNano.html. Cited 1 June 2007. Niemeyer, C.M. and C.A. Mirkin. 2004. Nanobiotechnology: Concepts, Applications and Perspectives. Weinheim, Germany: Wiley-VCH. Oberdörster, G.et al. 2005. Nanotoxicity: An emerging discipline evolving from studies of ultrafine particles. Environmental Health Perspective 113: 823–839. President’s Council on Bioethics. 2003. Beyond Therapy: Biotechnology and the Pursuit of Happiness Report. http://www.bioethics.gov/reports/beyondtherapy/. Cited 1 June 2007. Reisch, M.S. 2007. Nano goes big time. Chemical & Engineering News 85.4: 22–25. Resnik, D.B. 2004. Fair drug prices and the patent system. Health Care Analysis 12: 91–115. Resnik, D.B. and S.S. Tinkle. 2007. Ethical issues in clinical trials involving nanomedicine. Contemporary Clinical Trials 28.4: 433–441. Reuters. 1999. Health Informatics: Into the 21st Century. HealthCare Reports, Business Insight (February 1999). Saini, A. 2007. Making the poor pay. NewScientist 193.2597: 20. Service, R.F. 2005. Nanotechnology takes aim at cancer. Science 310.5751: 1132–1134. Strom, B.L. 2006. How the U.S. drug safety system should be changed. JAMA 295: 2072–2075. Sussman, N.L. and J.H. Kelly. 2003. Saving Time and Money in Drug Discovery—A Pre-emptive Approach. In Business Briefings: Future Drug Discovery 2003. London: Business Briefings Ltd. Thassu, D et al. 2007. Nanoparticulate Drug Delivery Systems, 2nd ed. New York: Informa Healthcare. Theis, T et al. 2006. nan’otechnol’ogy n. Nature Nanotechnology 1.1: 8–10. Tremblay, J.F. 2007. Drug patent struggles in Asia. Chemical & Engineering News 85.6: 11.

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Chapter 12

Nanoscience, Nanoscientists, and Controversy1 Jason Scott Robert

12.1

Introduction

Contemporary life sciences and biotechnology research is controversial. Whether the topic is embryos, evolution, genetics, neuroimaging, pharmaceutical discovery, synthetic biology, or xenotransplantation, the research is subject to public, political, legal, regulatory, clinical, and/or scientific controversy. In some cases, the controversy may not be worth engaging, given the credibility (or, rather, lack thereof) of those who would object. Often, though, those who would object must be taken seriously— and even where the objectors lack credibility, any response to them must itself be serious. These are basic elements of civility in a pluralistic society, and yet they are widely ignored when science and scientists are the subjects of controversy. As a scholar of the life sciences in society, I have tended to pay less attention to the question of generally whether research in chemistry, math, physics, or engineering is as widely deemed to be controversial as is research in biology and biotechnology— except, of course, where that research is oriented toward or undertaken in concert with the life sciences (as with engineering in relation to stem cell biology, or chemistry in relation to directed molecular evolution). But with advances in nanoscale science and engineering (NSE) research, it is hard to miss the fact that NSE is an exemplar of research in the natural and physical sciences that is controversial both in relation to the life sciences (as expected) but also in its own right. Whether because of the spatial or financial scale of the research, or because of the prospects for immense changes—good and bad—in science, industry, medicine, and society, or for a combination of these or other reasons, NSE research is paradigmatically controversial. So what? 1 I am grateful to two separate audiences, both in Chicagoland in August 2006 (NABIS) and October 2006 (International Institute for Nanotechnology, Northwestern University), as well as the editors of this volume, for their comments and thoughts on this work in progress. I am also grateful to members of my lab (especially Zach Pirtle and Jenny Brian) for ongoing, engaging discussions of science in society. My research is currently supported by the Center for Nanotechnology in Society, the Institute for Humanities Research, and the Center for Biology and Society, all at Arizona State University.

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I organize my claims as follows. First, I identify and briefly discuss a number of ethical and societal issues associated with NSE; second, I canvass a variety of scientists’ and engineers’ standard responses to claims that NSE (and science and engineering more generally) is controversial and assess their impropriety (as a cautionary tale, I discuss some recent events in stem cell biology in California and Canada); finally, I propose an alternative response and a strategy for implementing it. Throughout, my aim is to reflect critically on the roles and responsibilities of scientists, engineers, and ethicists in the face of controversial science and technology research and development. While my remarks are often general rather than specific to NSE, I hope to convince the reader that this as a strength rather than a limitation of my approach.

12.2

Societal and Ethical Implications of NSE

NSE research raises a large number of ethical, societal, and policy issues, from agenda-setting and funding through research, development, implementation, and use. As stipulated in the twenty-first Century Nanotechnology R&D Act of 2003 (PL 108–153), the United States Congress intended to ensure that: “ethical, legal, environmental, and other appropriate societal concerns, including the potential use of nanotechnology in enhancing human intelligence and in developing artificial intelligence which exceeds human capacity, are considered during the development of nanotechnology” (Section 2(b)(10) ). This goal is to be accomplished by: ● ●

●

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Establishing a societal implications research program; Requiring that Nanoscale Science and Engineering Centers (NSECs) address societal implications; Integrating societal concerns with nanotechnology research and development for widespread benefit; and Providing for public input and engaging in public outreach activities through the National Nanotechnology Coordination Office (NNCO).

These activities are well underway. The NNCO is coordinating a wide range of efforts linking together nanoscale scientists and engineers with ethicists and policy decision-makers (http://www.nano.gov/html/about/nnco.html), NSECs have established Societal and Ethical Implications of Nanotechnology programs (e.g., at the International Institute for Nanotechnology at Northwestern University, http://www. nsec.northwestern.edu/SocialEthical.htm), and the National Science Foundation has funded a Nanoscale Informal Science Education network and two large NSECs focused on Nanotechnology in Society. The latter are based at Arizona State University (http://cns.asu.edu/) and at the University of California at Santa Barbara (http://www.cns.ucsb.edu/home/) and are part of a wider network of funded research centers and programs throughout the United States (http://www.nsf.gov/ news/news_summ.jsp?cntn_id = 104505&org = olpa&from = news).

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Additionally, there is now a journal devoted specifically to NSE ethics (Nanoethics), forums for NSE ethics and policy articles in such journals as Nature Nanotechnology, and anthologies and yearbooks are either already published or are currently being planned. Table 12.1 presents some of the stock ethical, societal, and policy issues that form the core of this ongoing research.

Table 12.1 Stock ethical, societal, and policy issues associated with nanoscale science and engineering (NSE). Several issues are NSE-specific, several are intensified with NSE, and some arise generally in relation to emerging technological research and development. The table describes the source of the normative issue, but invokes no particular normative analysis Issue

Description, source

1. Health and safety concerns

Spatial scale-dependent properties of nanoparticles raise concerns about their potential toxicity. Will it be possible to protect the health of laboratory workers, employees of manufacturing facilities, patients, and consumers? Spatial scale-dependent properties of NSE raise concerns about the ability to identify, monitor, and moderate potential risks; will current national and international regulatory regimes suffice? Financial and spatial scale-dependent properties of NSE raise the potential for “revolutionary” effects throughout society. Additionally, NSE is predicted to be part of a technological convergence with biotechnology, computing and information technology, and cognitive sciences, expected to profoundly alter the human condition. Will it be possible to anticipate, plan for, and cope with large-scale effects within and between societies? What are the opportunity costs associated with a significant focus on NSE, and how can these be moderated? There are industrial, military, medical, academic, and fundamental technological motivations for nanoscale science and engineering. What factors determine the research agenda for NSE? What factors should determine the research agenda? As with biotechnology, there are concerns about key patents for enabling technologies—who owns them, their breadth, their interrelationships, licensing considerations. Will the IP regime help or hinder research and commercial aspects of NSE? What IP strategies are being and should be pursued? (See also regulatory issues, range of potential impact considerations, and research priorities, funding issues.) As with technologies of all sorts, there is the potential for inequitable distribution of technologies within and between societies. Will NSE be different? (See also research priorities, funding issues, and intellectual property issues.) In biomedicine, the path from bench to bedside is long and difficult. Will NSE be different? (See also health and safety concerns and regulatory issues.) Due to the spatial scale of NSE, nanotechnologies may enable unprecedented opportunities for detection, surveillance, and intervention into daily activities. Will it be possible to devise and enforce appropriate regulations? (See also regulatory issues.)

2. Regulatory issues

3. Range of potential impact issues

4. Research priorities, funding issues

5. Intellectual property (IP) issues

6. Equity and access considerations

7. Clinical translation concerns 8. Privacy, confidentiality

(continued)

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Table 12.1 (continued) Issue 9. Potential dualuses unintended consequences

Description, source As with technologies of all sorts, there is the potential for the “dualuse” of nanotechnologies: originally developed for one purpose, a technology is adopted for adapted for malevolent ends. Additionally, technologies engender unintended consequences of many kinds. Will it be possible to devise and enforce appropriate safeguards to minimize risks? (See also regulatory issues, and privacy, confidentiality.)

It is plainly evident that most of the issues highlighted in Table 12.1 are neither unique to nanoscale science and engineering, nor novel in this context. For instance, intellectual property concerns exist throughout the research enterprise, as do worries about military and corporate influence on the academic research agenda. Yet some concerns, especially about health and safety risks and about the suitability of regulatory regimes, are certainly intensified with NSE simply because of the spatial scale of the research. Moreover, the financial scale of the research—given the enormous investments in nanoscale science and engineering in the United States and elsewhere—serves to intensify the concerns about research agendas, equity, and opportunity costs. And the potential for widespread effects—particularly in industry (manufacturing, workforce) and medicine (drug discovery drug delivery, device engineering, health effects)—similarly serves to heighten the likelihood of dramatic societal fallouts from NSE, both good and bad. So, from the perspective of ethics or policy, or in consideration of the societal dimensions of research and development, is nanoscale science and engineering unique in any interesting ways? Not particularly. Does that make it any less important to attend to societal, ethical, and policy concerns? Absolutely not. Indeed, just the opposite may be true: if NSE raises (even without intensifying) ethical, societal, and policy concerns that are raised by many other technologies, and that have not been adequately addressed in other quarters, then that suggests an even greater need for scrutiny of these considerations in the context of nanoscale science and engineering. That said, given the interestingly different contexts of discovery and application and the diversity of fields and activities that comprise nanoscale science and engineering, the very idea of a distinct and homogeneous “nanoethics” is poorly conceived. Though there may be some ethical, societal, or policy issues that are best explored with regard to NSE as a whole, we have found it far more productive to narrow our attention to particular domains of research and development, and even to particular kinds of potential NSE-enabled technologies, in order more adequately to explore these issues. Within our group at the Center for Nanotechnology and Society at Arizona State University, one area of emphasis is the NSE-enabled development of and refinement of implantable neural prosthetic devices. One basic premise is that advances in NSE should yield solutions to a fundamental technological challenge in neural prosthetics design—the development of small, physically non-invasive, flexible, reliable, chronic, multielectrode recording and signalling methods for the cerebral neocortex. Such advances may for instance include

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miniaturization strategies or strategies for harnessing scale-dependent properties of nanomaterials as coatings for implantable devices or their components. The design of neural prosthetics raises an enormous range of ethical, societal, and policy issues, from considerations about demonstrating the safety and efficacy of these devices in preclinical and clinical studies to determining the perspectives of intended consumers (especially people with disabilities—and especially given the controversy within Deaf communities about an early neural prosthetic, the cochlear implant), and from the allocation of scarce research dollars to such hightech interventions with limited clinical usefulness to worries about potential misuses of neural implants for surveillance (mind reading) or even “substituted decisional authority” (mind control). To ask whether these issues are unique to nanoscale science and engineering is to miss the point that NSE contributes to technological advances that are, in their own right, worthy of ethical, societal and political scrutiny.

12.3

NSE and Controversy2

Nanoscale science and engineering is controversial in at least the ways canvassed above. So what? How should we respond to such claims? More generally, what are the roles of scientists, engineers, and ethicists in the face of claims that some area of science or engineering is morally, socially, or politically controversial? At least three kinds of strategies have been widely adopted in the face of controversy. Denial is especially popular, and I have touched on it already. Also popular are ignorance and its converse, dogmatism. Table 12.2 summarizes these three responses. I will elaborate on them in turn.

Table 12.2 Three standard strategies for responding to claims that science or engineering research is controversial. See text for additional details Strategy

Modus operandi

Denial

Deny the existence or severity of controversy, or deny that there is anything new about this particular controversy, so as to absolve any responsibility to engage critics. Attempt to draw a firm line between the context of discovery and the context of application, and ignore the personal or professional responsibility of scientists and engineers for the applications (development, use, and implications) of their research. Dogmatically debate critics, all the while assuming that critics are simply wrong. This strategy usually entails paying lip service to the critics via public engagement exercises that are more aptly described as public relations exercises.

Ignorance

Dogmatism

2 In most of what follows, my emphasis is on science and scientists rather than engineering and engineers–even though most of what I say is generalizable. This is because the case for science and scientists is the much more difficult case to make.

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Denial is an exceptionally popular strategy, involving either the denial of any controversy, the denial of severity of controversy, or the denial of the novelty of the controversy. The intent is to undercut the credibility of the critics and their objections, and to absolve scientists’ and engineers’ of any responsibility to engage critics. Some commentators use history as a tool of denial: such and such is just more of the same, and there is nothing new here. This is a very popular strategy within biotechnology ethics; for instance: ●

●

humans have been engaged in biotechnology for 6000 years, at least since the invention of beer, and modern techniques of genetic engineering are essentially the same, so don’t worry your pretty little head; and humans have been engaged in enhancement activities since the beginning of civilization—we seek out spiritual rituals and medical care for our kids, we send them to school (and not just any schools, but the best schools), and so on, simply in an effort to enhance their prospects for success; modern techniques of genetic engineering, coupled with cosmetic surgery and the use of pharmaceuticals are part of essentially the same project, so don’t worry your pretty little head.

And so on. What is most interesting about these responses is that even though a kernel of content may be accurate—that biotechnology really is ancient and that biotechnological and biomedical enhancement really are in important ways similar to other enhancement techniques and part of overarching enhancement projects— there is no warrant for the injunction not to worry. The strategy of making a plausible descriptive claim about a state of affairs and then making a further normative claim is logically fraught and yet unfortunately rhetorically powerful. A second standard strategy is best described as ignorance. This strategy involves actively ignoring or passively being ignorant of the social context of scientific discovery and the societal dimensions of scientific research. I suspect—indeed, I hope—that passive ignorance is more common than active ignorance, but passive ignorance becomes active when social issues are made salient and then willfully ignored. In this situation, ignorance involves a firm distinction between the context of discovery (what a scientist or engineer does in the lab, usually idealized, often romanticized) and the context of application (where the discovery is operationalized or applied, whether by being used as a gateway to further discovery, or turned into a product, or in some other way made useful). It also usually involves the claim that discovery is serendipitous and that it is impossible to predict the potential usefulness or applicability of scientific discoveries. And it usually involves a third claim that every discovery can be used in any number of ways, some good and some bad, such that worry about such uses is a waste of time and energy. So, in the end, either research is not controversial (but applications may be) or research may be controversial, and the claim is that it is just not scientists’ or technologists’ job to consider such concerns about controversial applications. Instead, let the ethicists lose sleep. These sorts of moves ignore the evidence that the context of discovery and the context of application are rarely entirely separate; further, they ignore the plain truth that the context of discovery is increasingly defined by the context of application (consider funding arrangements); instead, they pass the buck, whether actively or passively.

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Dogmatism is the third standard strategy. The modus operandi is to welcome the charge that the research is controversial, and either to heavy-handedly dismiss all objections or to appear to open the door to public discussion and debate aimed at resolving the controversy presumably by persuasion one way or the other, or by compromise. The former is increasingly less common, replaced by what appears to be, on the surface, a much more acceptable strategy of promoting healthy discussion and debate. Except, unfortunately, that scratching the surface just a little reveals the charade: all that glitters is not gold. Too often, the putative openness is in fact just window-dressing, public relations rather than public engagement. Consider stem cell research, and in particular the creation of part-human chimeras with human neural stem cells. When Stanford’s Irving Weissman first pondered the creation of what has come to be known as the “human neuron mouse”, he actively sought out guidance from a legal scholar at Stanford, Henry (Hank) Greely. Greely struck a committee to consider the morality of creating a mouse with a significant number of human neurons in its brain; Weissman awaited their report prior to undertaking the experiment. After some deliberation, Greely’s committee issued a report recommending that Weissman proceed with caution. (Apparently, he never did the experiment; the reasons why remain unclear.) Throughout, Weissman maintained the public image of the thoughtful scientist, worried about the ethical propriety of his research, open to potential moral limitations on the research he is permitted to undertake. So far, so good. Except that Weissman had this to say, too: “Anybody who puts their own moral guidance in the way of this biomedical science, where they want to impose their will—not just be part of an argument—if that leads to a ban or moratorium. … they are stopping research that would save human lives” (as cited in Mott 2005, ellipsis in original). I am, of course, willing to grant that Weissman’s words were taken out of context by the journalist (whose article is certainly careless on several fronts). But taken at face value, the quotation suggests the following dogmatic attitude: debate and argument are most welcome, so long as the outcome is a (foregone) conclusion in favor of permitting the research; anything else, any moral limitation on the research, would be unacceptable (and, indeed, in this case, sinful given the potential loss of human lives). So much for a nondogmatic response to moral concerns about scientific research. Another, related kind of dogmatic response is to be on the cutting edge of the ethics debate3—but only for political reasons, not substantive scientific ones. It is becoming increasingly common for scientists (and, indeed, for corporations) either to find ethicists for hire or to take on the task of ethical reflection themselves. The ambition is always to go forward with the controversial research—and often to be first. The modus operandi is to take the offensive, and to position oneself as the thoughtful responsible scientist (or industry) who identifies ethical concerns (moral controversy about science) and who claims she/he would not go forward until the

3 Françoise Baylis identified this important variant of a dogmatic response. I thank her for the suggestion and our ensuing discussion.

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ethical issues are resolved. Then, s/he proceeds with the controversial research and, if challenged, points back to the prior ethical reflection as evidence that s/he has satisfactorily resolved the moral concerns—else she would not have proceeded. Logically, the reasoning is fallacious—the fallacy of affirming the consequent: If the ethical issues have been satisfactorily resolved (x), I will proceed with my controversial experiment (y); I am proceeding with my controversial experiment (y); therefore, the ethical issues must have been satisfactorily resolved (x)—if x, then y; y; therefore x. Despite the fallacy, the reasoning is eminently effective as a political strategy.4 Other strategies, such as equivocation and deflation (and especially the use of inapt analogies to explain away moral controversy) may be used on their own or in combination with denial, ignorance, or dogmatism regarding morally controversial science or engineering. But the three I have highlighted above appear to be most widely used. This is understandable—for instance, they are self-preserving, and so allow individuals and communities to protect themselves against charges of negligence while effectively permitting business as usual; moreover, each strategy may, on occasion, be locally appropriate, as when the complainant clearly refuses to engage in good faith. But despite these qualifications, such strategies are simply not suited to the task of defending good science and engineering in a civil society. And when particular science and engineering projects are deemed controversial, then that is indeed the task at hand. Again, the case of stem cell biology affords an opportunity to probe these issues, and provides a cautionary tale for those of us engaging the controversial dimensions of nanoscale science and engineering. In December 2006, the Canadian government announced the Board of Directors of Assisted Human Reproduction Canada (AHRC). AHRC’s mandate is to oversee technologies and practices of assisted human reproduction and related research in Canada (for details, see http:// www.hc-sc.gc.ca/hl-vs/reprod/agenc/index_e.html). Inter alia, this agency is charged with making decisions regarding licenses for research and other activities deemed to require a license (“controlled activities”) in the agency’s enabling legislation, the 2004 Assisted Human Reproduction Act (http://laws.justice.gc.ca/en/A-13.4/ index.html). Following the announcement of the Board of Directors, the media in Canada had a field day. The first report, in The Globe and Mail (Abraham 2006), set the tone, as it was picked up by many other newspapers (sometimes verbatim). Through quotations from two scientists and a health law professor, the journalist characterized the Board of Directors as handpicked expressly to stifle stem cell research and reproductive technologies in Canada. In particular, the article described four members of the Board in some detail, lumping them together as social conservatives who may influence the Board in ways harmful to the interests of

4

Logically, two alternative constructions are valid: if x, then y; x; therefore y (by modus ponens) and if x, then y; not y; therefore not x (by modus tollens). See also Chapter 1 of Robert (2004) for an account of ‘hedgeless hedging’ that is rhetorically similarly effective but in a different context.

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stem cell scientists. The other four members of the Board, as well as its Chairman and President, were mentioned only briefly. There is no doubt that (embryonic) stem cell research is controversial. Quite apart from the destruction of human embryos required for deriving new embryonic stem cell lines, there are longstanding concerns about the creation of embryos specifically to be destroyed. For instance, there are concerns about the safety and wisdom of egg donation for creating new embryos (whether through in vitro fertilization or somatic cell nuclear transfer), and about the potential coercion of infertility patients to donate embryos (whether frozen or fresh) for research purposes. And, of course, stem cell research is only one of the topics to be covered by the AHRC—and not necessarily the most important one, since the Board deals with all aspects of assisted human reproduction. Even so, the media circus centered around stem cell research in particular, and around the potential for a conservative agenda to dominate the Board’s deliberations. In the article in The Globe and Mail and in another in the Canadian Medical Association Journal (CMAJ) (Eggertson 2007), the stem cell scientist quoted at most length is Michael Rudnicki, scientific director of the Stem Cell Network in Canada.5 In his comments to journalists about the AHRC Board, Rudnicki put forward an image of science, scientists, and politics that is terrifically naïve— scientifically and politically. He complained in particular that the Board is stacked against stem cell science. The following passages from the CMAJ article include some of Rudnicki’s remarks, as presented by the author of that article: “It was supposed to be an expert [board] and these are not experts. These are people who have agendas and opinions,” Rudnicki says of those 4 board members. “If you wanted to see the legislation enacted in good faith, I would think that you would want to have people who did not have a clear stated position in opposition of what they’re supposed to be regulating.” The choices “raise the possibility of political interests at work,” he added. “It’s analogous to having a Jehovah’s Witness who is totally opposed to transfusions being appointed to the board of the Canadian Blood Services.”

In these passages, Rudnicki makes three movies: he offers an untenable analogy that can only be described as inflammatory; he effectively slanders the Board members (and especially those whom he personally deems to be socially conservative, regardless of whether they are in fact conservative); and he complains that the process was political (precisely because he fears that his own agenda will not be advanced). Rudnicki’s response (as constructed by the reporters) is entirely inappropriate on several counts. (This leaves open the possibility that Rudnicki was quoted out of context, though an extended report on the Canadian Broadcasting Corporation bears out my interpretation.) First, it fails to engage any specific concerns about

5 I should disclose that from 2003–2005, I was a funded member of the Stem Cell Network, and withdrew from the Network when I moved from Canada to the United States. I was then, as now, critical of some of the Network’s activities, particularly in relation to the commercialization of stem cell research and the apparent unwillingness to engage in thoughtful, open-ended debate about the ethics and politics of stem cell research.

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stem cell biology while attempting to discredit those who raise concerns—the key ingredient of an ad hominem attack. Second, it pretends to advance an objective, scientific point of view as against the putatively conservative political point of view – without appreciating that advocating an agenda in favor of stem cell research is a political act, and without recognizing that a Board stacked in favor of stem cell research would have been equally political. Third, it ignores controversy and dogmatically endorses one amongst many reasonable points of view, all the while pretending that science is being inappropriately politicized. Rudnicki’s response is all too common amongst scientists and commentators— consider Chris Mooney’s writings about the politicization of science in the United States according to which pure, objective science (a myth of epic proportions) is bastardized by Republicans (Mooney 2005; cf. Sarewitz 2006). But what Mooney and Rudnicki and others of their ilk fail to appreciate is that science today is always already political; there is no unequivocally pure science, and no unequivocally pure scientist, speaking truth to power. To advance science is to advance a political agenda. In many instances, it is an agenda worth advancing, not just because it is science, but because science is often good and worth advancing. Yet the good of science must always be demonstrated and not assumed. Alas, the myth of scientific purity remains ever-present, despite no enduring warrant for believing it. At the heart of the standard, unacceptable responses to the diagnosis of controversy are two unacceptable images of science. One is an unacceptable image of science as value-neutral; the other is an unacceptable image of science in society, according to which science is the only epistemic game in town. But these images have been long since abandoned by everyone who thinks hard about science, and about science in society. Instead, we know full well that scientific knowledge is fallible, partial, and socially generated (the context of discovery is a social context, though not a particularly public one). And we know full well that scientific knowledge is enormously, but not exclusively, important. Accordingly, we must generate an alternative, and more appropriate response to scientific controversy, one more in line with this more reasonable view of science in society.

12.4

Controversy and Accountability

My argument—more accurately, my argument sketch—in this and the next section proceeds in three not entirely discrete steps. First, the moral permissibility of scientific research depends on its scientific and/ or social significance, which is an accountable enterprise. Second, accountability requires transparency, good will, an appropriate sense of obligation, and clear stopping rules. Finally, with accountability comes due respect. This particular route to addressing controversy via accountability at least stands a chance of building enduring support for science based on something other than myth alone. Good science is ethical science. For scientific research to be morally warranted, it must be scientifically and/or socially significant. Whereas scientific validity is

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usually determined by peer-review, this may not be the most appropriate means for determining scientific significance. Consider that an insignificant experiment may be judged by an insular group of scientist-peers to be perfectly valid—because their insularity prevents them from questioning the assumptions that challenge the scientific significance of the experiment. As science aims at discovering significant truths (Kitcher 2001), it is important to assess scientific significance more appropriately. Prospects include considering the scientific significance of a research program alongside its social significance, and providing a publicly accessible account of scientific significance, in order to enable a fuller exploration and assessment of significance. Presumably, even though the results of particular experiments cannot be fully anticipated, scientists have good scientific reasons for conducting their experiments. That is, while scientists cannot predict exactly how experiments will turn out (else there would be no reason to perform the experiment), scientists surely do have reasons for performing one experiment and eschewing another. It is not too much to ask scientists to make these reasons transparent, such that a research program wears its logic on its sleeve, for anyone to see (Robert 2006, 843–844).

On this view, it is not enough for an experiment to be scientifically valid as judged by one’s immediate peers who are themselves often already committed to a particular line of inquiry with all its assumptions and ambitions. Rather the experiment must be assessed on broader grounds whereby those assumptions and ambitions are themselves identified, elucidated, and justified. This is a kind of accountability—of requiring a publicly accessible justification, an account of one’s proposed research and the transparent reasons one has for conducting it in this particular way at this particular time with these particular ends. To this end, Kitcher (2001) has described the heuristic of significance graphs. Such graphs “reflect the concerns of the age”, both scientific and social, and provide a kind of map for explaining and interpreting the importance of particular decisions within research programs. They are historicized and perhaps idealized, but they give an accessible sense of the logic of scientific research programs, and may thus serve to help justify the research. Justification is crucial: Well-articulated scientific justifications may help to dispel the appearance of hubris and irresponsibility. But to date scientists are partially responsible for generating this image, especially when they turn away from public justification of their research and demand to be left alone, unburdened by non-scientific rules and regulations. The problem with this response is that it fails to recognize the social context in which scientific research is deeply embedded; it fails to take seriously that scientific research, like all scholarly research, is a public enterprise – even where the research funds are not provided directly by the state, the research itself is undertaken in a civic context, bound by rules, regulations, and political mores (Robert 2006, 844).

This claim suggests a second dimension of accountability, namely the need to consider that science—even privately funded science—is a social enterprise. Scientists, after all, are people and, accordingly, are social beings with civic responsibilities and public obligations. The case is made most straightforwardly where scientists make promises about beneficial social outcomes specifically in order to get a grant. Where the research fails to deliver, the scientist should be help accountable – especially

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where the promises never should have been made in the first place. But even where there is no accountable promise to deliver a particular outcome from a scientific research program, this does not mean that scientists are off the hook, that there is no accountability. Consider the claim that science, like art, should be thought of as an intrinsically valuable cultural activity. This view is distinct from two other popular views: one, that all scientific research has the potential for serendipitous deliverables, and so scientists should be left alone (and fully funded) to do whatever research they see fit (the serendipity view), and two, that all scientific research should have specific deliverables, and should be specifically and strategically guided toward those deliverables (the strategic view), The serendipity view has been popular since Vannevar Bush’s report, Science, The Endless Frontier (Bush 1950) insisted on funding basic science as a means to deliver on the fullest potential of scientific inquiry. The strategic view is more recent, and emphasizes the need to demonstrate the value (usually, the economic value) of investment in scientific research; at its extreme, this view discounts the value of basic research in favor only of research that promises (and delivers) specific outcomes. By contrast, the cultural activity view holds that science is, like art, an intrinsically valuable cultural activity that may or may not yield specific outcomes but that is nonetheless undertaken within particular traditions and with particular customs and mores. Just as art is not quite undertaken simply for art’s sake—but rather to express significant meaning through a medium—so too is science not quite undertaken just for science’s sake; but just as art is not exclusively undertaken for expressly crass commercial reasons, so too is science similarly undertaken for other intrinsic and extrinsic reasons (of which commerce is but one). The governance of art and the governance of science are not quite analogous, and the metaphor must obviously be explored further. But the cultural activity view of science is, in practice, more difficult to defend than either the strategic or serendipity view, for it requires scientists to give up their privileged epistemic claim and the myth of scientific purity in favor of a more accurate depiction of science as an essential component of civilization, but not as the be all and end all of human inquiry. Were scientists to take on this particular challenge, a philosophical challenge, to be sure, I suspect they would dramatically improve their ability to grasp the nature of and adequately deal with charges of controversy at the intersection of science and society. Taking seriously the moral and cultural justification of science and its significance is a critical first step. But note that better (scientific) justifications of scientific research will not entirely suffice to resolve controversies, for these disputes are more about (fact-related) values than about (value-laden) facts. How, then, to deal appropriately with divergent values at the heart of controversial science?

12.5

A Role for Ethicists

I am suggesting, in line with Kitcher (2001) and others (Wilsdon and Willis 2004), that understanding the scientific and social significance of science, let alone determining it, is a multidisciplinary, multi-sectoral task. It is too important to be left

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only to scientists, though scientists should be involved; it is similarly too important to be left only to ethicists, politicians, and other stakeholders—though, again, they should be involved. Understanding and determining significance is best described as a collaborative, performative enterprise to be undertaken publicly and deliberatively in spaces cultivated for this end. Demos, a UK-based thinktank on the role of science in society, has advocated for “see-through science”. As an alternative to public science-literacy programs based on the deficit view of public understanding, see-through science aims simultaneously to improve scientific literacy (Maienschein et al. 1998) while also promoting upstream engagement between scientists and publics to promote better science (Wilsdon and Willis 2004). See-through science is not easy to achieve. Opportunities for upstream engagement are scarce, and tools for talking are scarcer still (cf. Parens et al. 2005). Here, then, is a role for ethicists in the face of controversial science, a role much more appropriate than those standardly adopted. Ethicists tend to respond poorly to controversial science. Ethicists too often gather at the extremes—deflation (denial, ignorance) on the one side, inflammation (many varieties of dogmatism) on the other—in attempts either to put out the flames or to fan them further. They end up either smothering important disagreements or generating more heat than light. These caricatures of practical ethicists as, alternately, firefighters and pyromaniacs are well-deserved; they are also images that many ethicists actively adopt. I prefer an alternative image, one initially introduced almost 15 years ago by Margaret Walker (Walker 1993) and recently extended in various helpful ways (Sherwin and Baylis 2003; Robert 2007). This is the image of practical ethicists (actually, ethics consultants in Walker’s original piece) as architects of moral space—as those who create and maintain literal and figurative spaces for moral discussion and debate. As with medicine more generally, so too with practical ethics: it is better to prevent serious problems than to deal with them when they arise acutely. But, of course, there are better and worse ways of prevention. And so I envision bioethicists as those who should strive, with integrity and wisdom, to foster upstream conversation and collaboration between scientists and various publics (including ethicists but also politicians, industry representatives, and regular folks, inter alia) about the content, warrant, direction, governance, and implications of science as a cultural activity. The task of practical ethics, then, is the discovery and elucidation of moral and other values, the fostering of critical reflection on those values in context, and the cultivation of constructive moral discourse about conflicting values in a local or global decisional or policy context. Practical ethicists are thus gadflyhandmaiden-architects of moral space. (I am, of course, well aware that this romantic vision of bioethicists is not borne out in the discipline as we know it today. But I am hopeful [Robert et al. 2006; Robert 2007].) Science, as a normative enterprise in a civil society, requires good will to proceed. Not just on the part of critics of science, but also of its proponents, good will engenders appropriate trust in the political deliberations that enable or disable scientific progress. Though I can only hint at the reasoning here, my view is that scientists and ethicists have obligations to be good citizens in this domain, and to take nothing for granted in establishing that science really is a good and valuable part of civilized society.

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Where research is controversial, scientists may comport themselves in such a way as to mediate or moderate the controversy, or they can make things worse by themselves behaving in controversial ways. It is plainly evident that only the former option offers any prospect for maintaining public trust in science and scientists, and fostering the socially responsible advance of research and development in science and engineering. My aim in this essay has been to motivate such collaborations in the context of nanoscale science and engineering. To date, too many scientists and engineers have proceeded from denying that NSE raises any new ethical issues (which may be true) to claiming that attending to and funding research on societal and ethical dimensions of nanoscale science and engineering is unnecessary (which is clearly false). In response, too many ethicists have bent over backwards to try to demonstrate the novelty of nanoethics (with terrifically limited success). The end result is a field ripe for ethical and societal analysis that is, alas, polarized and politicized in unproductive ways. My arguments in this essay are general but generalizable; efforts in nanoscale science and engineering afford an excellent opportunity for scientists, engineers, ethicists, and other stakeholders jointly to reinvent the social contract between science and society, and to break new ground for more productive interactions in the future.

References Abraham, C. 2006. Critics troubled by new fertility panel. The Globe and Mail (23 December). Bush, V. 1950. Science, the Endless Frontier. Washington, DC: National Science Foundation. Eggertson, L. 2007. New reproductive technology board belies expert selection process. Canadian Medical Association Journal 176: 611–612. Kitcher, P. 2001. Science, Truth, and Democracy. New York: Oxford University Press. Maienschein, J et al. 1998. Scientific literacy. Science 281: 917. Mooney, C. 2005. The Republican War on Science. New York: Basic Books. Mott, M. 2005. Animal-human hybrids spark controversy. National Geographic News. 25 January. http://news.nationalgeographic.com/news/2005/01/ 0125_050125_chimeras.html. Cited 1 June 2007. Parens, E et al., eds. 2005. Wrestling with Behavioral Genetics: Science, Ethics, and Public Conversation. Baltimore, MD: Johns Hopkins University Press. Robert, J.S. 2004. Embryology, Epigenesis, and Evolution: Taking Development Seriously. New York: Cambridge University Press. Robert, J.S. 2006. The science and ethics of making part-human animals in stem cell research. FASEB Journal 20: 838–845. Robert, J.S. 2007. Systems bioethics. The American Journal of Bioethics 7.4: 80–82. Robert, J.S et al. 2006. Systems bioethics and stem cell biology. Journal of Bioethical Inquiry 3: 19–31. Sarewitz, D. 2006. Scientizing politics. Issues in Science and Technology 22.2 (Winter). http:// www.issues.org/22.2/br_sarewitz.html. Cited 1 June 2007.

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Sherwin, S. and F. Baylis. 2003. The feminist health care ethics consultant as architect and advocate. Public Affairs Quarterly 17: 141–158. Walker, M.U. 1993. Keeping moral space open. Hastings Center Report 23.2: 33–40. Wilsdon, J. and R. Willis. 2004. See-through Science: Why Public Engagement Needs to Move Upstream. London: Demos.

Chapter 13

Nanotechnology and the Poor: Opportunities and Risks for Developing Countries Todd F. Barker, Leili Fatehi, Michael T. Lesnick, Timothy J. Mealey, and Rex R. Raimond

Millions of people worldwide continue to lack access to safe water, reliable sources of energy, healthcare, education, and other basic human development needs. Since 2000, the United Nations Millennium Development Goals (MDGs) have set targets for meeting these needs. In recent years, an increasing number of government, scientific, and institutional reports have concluded that nanotechnology could make significant contributions to alleviating poverty and achieving the MDGs. Concurrently, these and other reports have also identified potential risks of nanotechnology for developing countries (UN Millennium Project 2005). Perceived by many as the next “transformative technology”—like electricity or the Internet—nanotechnology encompasses a broad range of tools, techniques, and applications that manipulate or incorporate materials at the nanoscale in order to yield novel properties that do not exist at larger scales. These novel properties may enable new or improved solutions to problems that have been challenging to solve with conventional technology. For developing countries, these solutions may include more efficient, effective, and inexpensive water purification devices, energy sources, medical diagnostic tests and drug delivery systems, durable building materials, and other products. Additionally, nanotechnology may significantly increase developing countries’ production capacities by enabling manufacturing processes that create less pollution and have modest capital, land, labor, energy, and material requirements. Both the public and private sectors in developed and developing countries are investing heavily in nanotechnology research and development. More than 20 countries, including developing countries such as China, South Africa, Brazil, and India, have national nanotechnology programs, and many more are developing or expanding nanotechnology research and development capacity. The collective public and private sector investment in 2005 was approximately US$10 billion, up 20% from 2004 (Salamanca-Buentello et al. 2005). In addition, the number of patents on nanotechnology-related inventions (including those from developing country researchers) (Singh 2007), scientific literature citations (now up to 12,000 publications per year) (Colvin 2002), and nanotechnology-based products reaching the market are skyrocketing globally. The rise in nanotechnology investments and proliferation of applications has contributed to growing international dialogue about implications of the rapid evolution F. Allhoff, P. Lin (eds.) Nanotechnology & Society: Current and Emerging Ethical Issues, © Springer Science + Business Media B.V. 2008

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of nanotechnology, including potential near- and long-term social and economic disruptions, human health and environmental risks, and ethical, legal, and other impacts. Governments, companies, NGOs, universities, international institutions, standardization bodies, and other stakeholders have initiated a number of efforts to discuss, develop, and implement risk assessment, governance, standardization, and public involvement strategies to address these potential implications. Despite these efforts, there are few processes to collectively engage multiple stakeholders in addressing the opportunities and risks of nanotechnology for developing countries. Moreover, where processes do exist to identify linkages between nanotechnology and development, these activities remain disengaged from the predominant risk assessment, governance, standardization, and other key initiatives. These gaps are a significant concern, as current decisions in both developed and developing countries may result in policies, practices, and systems that have longterm impacts on whether nanotechnology will help or hinder the effort to address specific human development needs. To address this need, Meridian Institute, a non-profit organization that specializes in helping people solve problems and make informed decisions about complex and controversial societal issues,1 has convened the Global Dialogue on Nanotechnology and the Poor: Opportunities and Risks (GDNP) to close these gaps through a variety of strategies that raise awareness about the implications of nanotechnology for developing countries, catalyze actions that address specific opportunities and risks, and identify ways that science and technology can play an appropriate role in the development process. As part of the GDNP process, Meridian is convening a series of sector-specific activities, beginning with the International Workshop on Nanotechnology, Water, and Development, held October 2006 in Chennai, India.2 This workshop brought together participants from developed and developing countries and with a broad range of perspectives and expertise to discuss the range of challenges people in developing countries may face when developing and implementing strategies for improving access to clean water and opportunities for using nanotechnology to address water supply challenges, as well as risks, and other issues that need to be addressed in relation to specific nanotechnology applications.3 Meridian plans to 1 Meridian Institute is a non-profit organization whose mission is to help people solve problems and make informed decisions about complex and controversial societal problems. Meridian’s mission is accomplished through facilitation, mediation, information, and consultation services. Meridian’s work focuses on a wide range of issues related to environment and natural resources, climate and energy, agriculture and food security, international development, science and technology, health and safety, and security. Meridian Institute works at the local, national and international levels. For more information, please visit http://www.merid.org/. 2 For more information on the International Workshop on Nanotechnology, Water, and Development, please visit http://www.merid.org/nano/waterworkshop/. 3 To inform these discussions, Meridian provided the following background papers: “Nanotechnology, Water and Development”; “Overview and Comparison of Conventional and Nano-Based Water Treatment Technologies”; “Examples of Enabling Technologies for the Development of NanoBased Water Treatment Technologies”; and “Water and Development News Compilation.”

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convene other sector-focused workshops in the areas of commodities (agricultural, mineral, and non-fuel commodities), energy, and health care. In the following pages, we describe, as illustrative examples, possible opportunities and risks presented by nanotechnology for developing countries. Drawing extensively from the International Workshop on Nanotechnology, Water, and Development, we focus, in particular, on opportunities, risks and other issues in the context of nanotechnology applications for water, but also provide examples of applications for energy, health, agriculture and food.

13.1 13.1.1

Opportunities- Nanotechnology and Development Water

Nanotechnology for water purification has been identified as a high priority area because water treatment devices that incorporate nanoscale materials are already available and human development needs for clean water are pressing. Poverty and water are closely linked and access to water resources has become widely equated with ensuring that basic human needs are met. It is predominantly the poor of the world who depend directly on water and other natural resources for their livelihoods. In 2002, 1.1 billion people lacked access to safe drinking water, and 2.6 billion people lacked access to adequate sanitation (UN Millennium Project 2005). The consequences of lack of access to clean water and adequate sanitation are overwhelming: waterborne diseases and water-related illnesses kill more than five million people a year worldwide, 85% of these being children, according to the World Health Organization (UN Millennium Project 2005). Additionally, many children miss school because neither their homes nor schools have adequate drinking water or sanitation facilities and hundreds of millions of African, Asian, and Latin American families lose vital income from the lack of access to reliable drinking water and sanitation services (meeting the MDG target for clean water and sanitation is estimated to yield economic benefits close to US$12 billion a year4). Given the importance of clean water to people in developed and developing countries, numerous organizations are considering the potential application of nanoscience to solve technical challenges associated with the removal of water contaminants. Technology developers and others claim that these technologies offer more effective, efficient, durable, and affordable approaches to removing specific types of pollutants from water. A range of water treatment devices that incorporate nanotechnology are already on the market and others are in advanced stages of

4 The United Nation’s Millennium Development Goals (MDGs) set a target to halve, by 2015, the proportion of people without access to safe drinking water and basic sanitation.

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development. These nanotechnology-based products include nanofiltration membranes; nano-ceramic, clay, and polymer filters; zeolites; nanocatalysts; magnetic nanoparticles; and nanosensors. Nanofiltration membrane technology is already widely applied for removal of dissolved salts from salty or brackish water, removal of micro pollutants, water softening, and wastewater treatment. Nanofiltration membranes selectively reject substances, which enables the removal of harmful pollutants and retention of nutrients present in water that are required for the normal functioning of the body. It is expected that nanotechnology will contribute to improvements in membrane technology that will drive down the costs of desalination, which is currently a significant impediment to wider adoption of desalination technology. Rensselaer Polytechnic Institute in the US and Banaras Hindu University in India devised a simple method to produce carbon nanotube filters that efficiently remove micro- to nanoscale contaminants from water (RPI News and Information 2004). Made entirely of carbon nanotubes, the filters are easily manufactured using a novel method for controlling the cylindrical geometry of the structure. Carbon nanotube filters offer a level of precision suitable for different applications as they can remove 25 nm-sized polio viruses from water as well as larger pathogens such as E. coli and Staphylococcus aureus bacteria. The nanotube based water filters were found to filter bacteria and viruses and were more resilient and reusable than conventional membrane filters. The filters were reusable and could be cleaned by heating the nanotube filter or purging. Nano-engineered membranes allowed water to flow through the membrane faster than through conventional filters (Srivastava et al. 2004). Argonide, a private company in the US, using grant money from the US National Aeronautics and Space Administration, has developed a filter comprising oxidized aluminum nanofibers on a glass fiber substrate. These alumina fibers are positively charged, which enables them to filter bio-organisms such as bacteria and viruses from the water flow. Even though the pores in this filter are relatively large, the end result is extremely effective because the process provides a much higher flow rate than traditional membranes. The filter retains up to 99.999% of viruses, is currently in production, and can be used to clean water by applying muscle force with no extra energy needed, ideal for rural contexts. A project by North West University in South Africa, incorporated nanofiltration elements from Filmtec, a subsidiary of Dow Chemical Company, to purify drinking water supplies in rural communities. The Filmtec elements are used to treat municipal water supplies where salts such as nitrate, phosphate, sulphate, chloride, calcium, magnesium, and sodium ions must be removed (Hillie et al. 2006). The Long Beach Water Department, a public utility in the US, has developed a nanofiltration process referred to as the Long Beach Method, which uses existing nanofiltration membrane technology for desalination, but adds an innovative two-staged nano-filtration process that requires much lower pressure than other desalination methods. This unique process is now being tested on a larger scale (Water Industry News 2005). Nanomembrane filtration technologies may be suitable for some water contamination issues in some developing countries. As the South African example of using Filmtec

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filters in village-level filtration systems illustrates, nanofiltration technologies are becoming more easily accessible in some developing countries. Nanomembrane plants can be built as portable units, which can be assembled in the major urban centers and then transported to the outlying areas (i.e., rural and peri-urban) where they are needed. By building the plants as portable units, the initial capital required for the construction can be lowered. Zeolites, clays, and nanoporous polymers are also materials used for nanofilters. While these materials have been used for many years to purify water, recent improvements in scientists’ ability to manipulate on the nanoscale allow for greater precision in designing these materials, for instance, allowing much greater control over pore size of membranes (Cientifica 2003). Zeolites are microporous crystalline solids with well-defined structures. Generally they contain silicon, aluminium, and oxygen in their framework and cations, water, and/or other molecules within their pores. Many occur naturally as minerals and are extensively mined in many parts of the world. Others are synthetic and are made commercially for specific uses or produced by research scientists trying to understand more about their chemistry. Zeolites can be used to separate harmful organics from water and to remove heavy metal ions from water.5 Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO) has developed a process that enables low-cost, local production of synthetic anionic clay called hydrotalcite that can be used to remove arsenic and possibly fluorides from water and groundwater. Hydrotalcite, which is currently used in a variety of applications including antacids and time-release fertilizers, is synthesized by combining an ammonia solution with a mixed solution of magnesium or aluminum. The magnesium and aluminum solutions are both prepared with commonly occurring materials called magnetite and bauxite. CSIRO’s process salvages magnetite and bauxite from aluminum cans, reducing production costs and enabling local production. The production process can be scaled up or down and can be carried out in small plants or incorporated into nitrogenous fertilizer plants due to a similarity in production process. Methods are now being developed for deploying this technology in a product aimed at low-income communities. The clay could be sprinkled on top of the water, or sold in teabags that are steeped in water prior to drinking. At the community level, hydrotalcite can be installed in the form of an in-line filter in hand pumps. Researchers at Los Alamos National Laboratory have developed a new class of nanoporous polymeric materials that can be used to reduce the concentration of common organic contaminants in water to parts-per-trillion levels (Roco et al. 1999; Los Alamos National Laboratory). These organic nanoporous polymers with narrow pore-size distribution (0.7–1.2 nm) have been synthesized using cyclodextrins as basic building blocks. The researchers say that the binding between organic contaminants and the nanoporous polymer is 100,000 times greater than the binding between organic contaminants and activated carbon, which is commonly used in

5

See British Zeolite Association website, http://www.bza.org/, Cited 1 June 2007.

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wastewater treatment. These materials can be used for the purification of municipal water supplies or for recycling and reuse of industrial wastewater. Nanocatalysts include enzymes, metals, and other materials with enhanced catalytic capabilities that derive from either their nanoscale dimensions or from nanoscale structural modifications. These substances promote the chemical reaction of other materials without becoming permanently involved in the reaction. Controlling a material’s size and/or structure at the nanoscale can produce catalysts that are more reactive, more selective, and longer lasting. Consequently, smaller quantities of catalysts are needed, reducing raw materials consumption, byproducts and waste, and, potentially, the overall cost of catalysis. Nanocatalysts such as titanium dioxide (TiO2) and iron nanoparticles can be used to degrade organic pollutants and remove salts and heavy metals from liquids. People expect that nanoelectrocatalysts will enable the use of heavily polluted and heavily salinated water for drinking, sanitation, and irrigation (UN Millennium Project 2004). Using catalytic particles either dispersed homogeneously in solution or deposited onto membrane structures could chemically degrade pollutants instead of simply moving them somewhere else. Catalytic treatment of polluted water could be specifically targeted to degradation of chemicals for which existing technologies are inefficient or cost prohibitive. PARS Environmental, an environmental engineering firm, manufactures zero-valent iron used for in-situ remediation of microbial and organic (VOC) contamination in groundwater (US Environmental Protection Agency, 2007; Pars Environmental, Inc.). This technology has been approved and field-tested by the US Environmental Protection Agency (EPA) for the remediation of a so-called Superfund site that is highly contaminated with trichloroethylene (TCE). NZVI functions simultaneously as an adsorbent and a reducing agent, causing organic contaminants to breakdown into less toxic simple carbon compounds and heavy metals to agglomerate and stick to the soil surface. NZVI can be injected directly into the source of contaminated groundwater for in situ treatment or embedded in membranes for ex situ applications. Once released in the environment, the NZVI cannot be removed, though their consumption during reactions with contaminants and relatively low mobility may reduce the risk of environmental impacts. Inframat Corporation is developing a material composed of a highly porous nanofibrous structure that can be used to remove arsenic from drinking water by combining a nanofibrous MnO2 oxidative process with a granular ferric hydroxide adsorptive process (Inframat, 2001). The technology supposedly circumvents the limitations of today’s active-site nanoparticulate materials that have a strong tendency to form agglomerates, which limit the permeability of the reactive constituents into and through the agglomerated mass. Another company, EnvironmentalCare from Hong Kong, has developed a nano-photocatalytic oxidation technology for the removal of bacteria and pollutants from water (Nano-Fotocide). It uses nanocoated TiO2 filters that trigger a chemical process, which converts harmful pollutants into the harmless end products of carbon dioxide and water. In photocatalysis, water passing through a nanomaterial is also subjected to ultraviolet light, leading to the destruction of contaminants.

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Another example of potentially promising research is provided by researchers at the Universities of Illinois and Pittsburgh and Yeshiva University who are exploring the use of nanocatalysts to reduce pollution of oxidized contaminants (e.g., nitrates). Nitrate is a stable and highly soluble ion with a low potential for coprecipitation or adsorption so that removal of nitrates using conventional water treatment is difficult. This research focuses on identifying the most promising catalysts (e.g., bimetallic metal catalysts such as Pd-Cu) to use for the reduction of nitrate and other oxidized compounds and to gain fundamental understanding of the reactivity and selectivity of these new catalytic materials (Xu et al. 2005). Researchers at Rice University are exploring nanocatalysts to remove tricholorethylene and organic aromatic contaminants, mainly pesticides, from groundwater (Center for Biological and Environmental Nanotechnology). The researchers suggest that although each system requires a different catalyst and overall remediation strategy, nanoscale engineering of materials permits the design of more efficient systems. For instance, the researchers have developed a new way to produce high surface area (>250 m2/g) nanocrystalline titania, which under UV illumination is capable of photo-oxidizing a variety of molecules. Additionally, ongoing work on the environmental implications of fullerenes, particularly C60, led these researchers to hypothesize that the oxygen radical production capabilities of nanoscale C60 aggregates in water could be leveraged for degradation of contaminants. Magnetic nanoparticles are being investigated for a variety of chemical separation applications including water treatment because they have high surface areas and can bind with chemicals without the use of auxiliary adsorbent materials. Additionally, the application of surface coatings can functionalize the chemical reactivity of magnetic nanoparticles, making them suitable as nanocatalysts for the chemical decomposition of chemicals. Once adsorption or catalysis has occurred, the magnetic nanoparticles can be removed from the water using a magnet or a magnetic field and reused. Rice University is developing a method for circulating loose magnetic nanoparticles in contaminated water to bind with contaminants such as arsenic, and then removing the magnetic nanoparticles and the attached arsenic from the water using a magnetized filter. This technology is currently in the laboratory stage of development, and manufacturing methods are still being studied. Tata Chemicals in India has developed candle filters embedded with magnetic nanoparticles. The manufacturing costs of these filters are expected to be as low as 5% of currently available and comparable technologies. Additionally, the filter material could be made locally using available materials such as sand and rice husks. The University of Brasilia has developed a technology consisting of magnetic nanoparticles designed to absorb and remove oil from water. The technology can be used to magnetize clay to separate oil, for example in case of oil spills. The clay can then be collected using a magnet. Reversing the magnetic charge allows both the clay and the oil to be reused, although the clay will eventually become less effective as it gets clogged and loses its porosity. The technology has been tested

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in the lab and seems promising for magnetic separation of contaminants and nanoparticles, and could be promising in combination with other clays for specific applications because of its “tune ability,” affinity, and reactivity. The technology can also be used as “tags” to magnetize yeast cells to metabolize dyes in wastewater from textile plants. It is expected that the magnetic nanoparticles can also be used to magnetize other bacteria for treating additional contaminants. Nanosensors for the detection of contaminants and pathogens can improve health, maintain a safe food and water supply, and allow for the use of otherwise unusable water sources. Nanosensors can detect single cells or even atoms, making them far more sensitive than counterparts with larger components. Conventional water quality studies rely on a combination of on-site and laboratory analysis, which requires trained staff to take water samples and access to a nearby laboratory to conduct chemical and biological analysis. New sensor technology combined with micro- and nanofabrication technology is expected to lead to small, portable, and highly accurate sensors to detect chemical and biochemical parameters. The European Committee funded project BioFinger in developing a portable, versatile, and low-cost molecular detection tool. BioFinger is developing a handheld device that incorporates nano- and microcantilevers on a microchip. The microchip is disposable after each use, allowing it to be reconfigured with new on-chip cantilevers configured to detect different molecules. Each disposable chip is expected to cost around 8 (BioFinger; Information Society Technologies, 2005). The system could be used to analyze chemicals and bacteria in water. The BioFinger project was due to begin testing its system in 2005 amid expectations for a commercial product to be available on the market within 2 to 3 years. Researchers from the University of Buffalo in the US, with funding from the National Science Foundation, are developing a handheld sensor that can detect the presence of toxins potentially used as agents in biological warfare (Contrada 2003). The sensor will be composed of three components—an LED (i.e., lightemitting diode), a xerogel-based sensor array, and a complementary metal-oxide semiconductor (CMOS) detector, commonly used in miniature digital cameras. In experiments using this sensing system, the researchers successfully designed a prototype that detected the presence of oxygen. According to the researchers, the sensors can be constructed to detect many different toxins or to detect the same toxin in different ways as a fail-safe. When light from the sensors is imaged onto the face of the CMOS detector, an electrical signal is produced, which can be read by a personal digital assistant, mobile phone, or similar handheld device. A Binghamton University chemist has been awarded a three-year grant from the US Environmental Protection Agency to develop advanced nanosensors for continuous monitoring of heavy metals in drinking water and industrial effluent (Barker 2003). The researchers have already developed a prototype nanosensor that can concentrate and trap lead particles ten times smaller than a human hair. The researchers intend to develop a 1 cm2 prototype nanoreactor that is capable of detection and remediation of lead, cadmium, arsenic, hexavalent chromium, and copper.

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Energy

Access to electricity is not specifically among the MDGs, but it could help with most of them: pumping water for human use and for agriculture, powering rural clinics and refrigerating medicines, lighting schools, and helping people earn sustainable livings in their own businesses. “Access to basic, clean energy services is essential for sustainable development and poverty eradication, and provides major benefits in the areas of health, literacy, and equity. However, over two billion people today have no access to modern energy services,” according to Practical Action (Intermediate Technology Development Group). Some 2.4 billion people use traditional biomass energy—wood, crop residues, and dung—for cooking and heating, a number that is increasing rather than decreasing. This is inefficient for most purposes; it can cause burns and respiratory problems due to indoor pollution and, depending on the source of the biomass, can degrade environmental systems and resource bases. Cheap solar-powered electricity has long been an aspiration for tropical countries, but glass and silicon photovoltaic panels remain too expensive and delicate. Nanotechnology may allow for the production of cheap photovoltaic films that can be unrolled across the roofs of buildings. It may even be possible to paint solar power films onto surfaces. US-based company Nanosolar has developed nanotechnology-based solar panels that are produced by printing photovoltaic cells directly onto flexible plastic and foil (Rogers 2006). Nanosolar says that its panels are as efficient as silicon panels, but can cost one-fifth as much to produce. Nanosolar plans to sell the panels for use on the rooftops of large buildings and as stand-alone power plants, but is also developing solar panels designed to fit archways, columns, and other architectural elements. Global energy company BP and the California Institute of Technology are developing solar cells made from an array of nanorods that will be able to absorb light and collect solar electricity more efficiently than conventional solar cells (Inside Washington Publishers 2006.). The use of nanorods is also expected to make new design approaches for low-cost solar cells possible. Researchers from the Ecole Polytechnique Fédérale de Lausanne in Switzerland are developing nanostructured thin films containing cobalt and silicon to more efficiently produce hydrogen for fuel cells from water with solar light through a process known as photocatalytic water splitting (Bullis 2006). Iron oxide has long been considered for use in solar panels because of its water resistance, but its use has been limited by the inability of electrons to easily escape the material. The researchers overcame this limitation by adding the silicon to the material and forming it into structures with very high surface area that allows most of the material’s atoms to touch the water, improving the electron conductivity of the material. The researchers report that the enhanced films convert an “unprecedented” 42% of ultraviolet photons in sunlight into electrons, achieving an overall efficiency of 4%.

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UK company Hydrogen Solar is now developing a method to mass-produce solar cells containing the new material for use as a clean, CO2-free fuel for transport and home energy installations. Energy storage systems can store energy produced at off-peak times to be used at peak times; they can help provide photovoltaic energy throughout the day and night. Nanotechnology approaches include using nanoparticles and nanotubes for batteries and fuel cells. Nanomaterials manufacturer Altair Nanotechnologies is developing lithium ion batteries containing their proprietary nano-titanate material instead of graphite that can recharge and discharge significantly faster and more often than existing lithium ion batteries (Ring 2006). Because the nano-titanate material does not have to expand or shrink when ions enter and leave its particles during charging and discharging, the nano-titanate batteries can be charged over 9,000 times while retaining 85% of their charge capacity, while conventional lithium ion batteries typically have a useful life of 750 charges. The nano-titanate batteries can also be charged to 80% of their capacity in about one minute. Researchers from Seoul National University have identified a polymer material with large hydrogen storage capacity (Dumé 2006). The material is a conducting polymer called polyacetylene with titanium atoms attached, and it can hold 63 kg of hydrogen per cubic meter, which is more than any other material identified by the researchers. The researchers say that this new material can store large quantities of hydrogen under practical conditions.

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Health

Nanotechnology offers a range of possibilities for healthcare and medicinal breakthroughs, including targeted drug delivery systems, extended-release vaccines, enhanced diagnostic and imaging technologies, and antimicrobial coatings. Starpharma, an Australian biotechnology company, has developed VivaGel microbicide, a topical gel that could reduce the risk of HIV infection in women (Moldofsky 2004). It is said to be the world’s first drug based on nanoscale polymers known as dendrimers, which prevents HIV infections by binding to certain receptors on the virus’s surface. The interaction in turn stops HIV from attaching to receptors on cells in the human body (Halford 2005). Nanotechnology could also enable simple, accurate, small, and stable diagnostic tests and devices. UK nanotechnology firm Akubio is developing a portable, low cost rapid-response device for diagnoses of diseases such as malaria, avian flu, E. coli, meningitis, and some cancers (Cambridge Evening News 2006). The device employs the quartz crystal element used in wristwatches to determine the presence of specific disease marker proteins within blood samples. The device can be powered with standard batteries and could enable doctors to make instant diagnoses in the field, as an alternative to conventional diagnostic tests that often need to be sent away to laboratories, require expensive chemicals, and take days or weeks to yield results. Nanoporous membranes may help with disease treatment in the developing world. They are a new way of slowly releasing a drug, important for people far from

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hospitals. Making the nanopores only slightly larger then the molecules of drugs can control the rate of diffusion of the molecules, keeping it constant regardless of the amount of drug remaining inside a capsule. US nano-biopharmaceutical company NanoViricides, Inc. has developed a viral therapy that uses an engineered flexible nanomaterial containing encapsulated active pharmaceutical ingredients to target specific viruses such as avian flu and common influenza, and block and dismantle the viruses before they can infect cells (Business Wire 2006). The Multi-Imaging Center at the University of Cambridge is developing a slow release vaccine that may reduce vaccination costs by eliminating the need for boosters (Roumeliotis 2006). The vaccines are embedded in microspheres of calcium phosphate glass, a chemical that dissolves in the body. Nanoparticles within the microsphere regulate the slow release of the vaccine over time. The vaccines will be stable enough to be stored without a cold chain and will not require reconstitution or bactericides, both of which can compromise the safety of vaccines and lead to waste. Nanomaterials such as silver nanoparticles are being used in a variety of products such as textiles, paints, and coatings to provide antibacterial and antimicrobial protection. Australia’s Nanovations Pty Ltd. has developed Bioni Hygienic, a nanotechnology-based wall coating for hospitals that can kill microorganisms, fungal spores, and bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), an antibiotic resistant strain of Staphylococcus aureus (Infolink 2006). The coating is reported to be emission free and effective over time regardless of exposure to disinfectants and chemical cleaners.

13.1.4

Food and Agriculture

Several studies suggest that nanotechnology will have major, long-term effects on agriculture and the production of food, but it remains unclear how these changes will affect developing countries. Many of the promised advances for agriculture are similar to some promised advances in drug delivery in human medicine: time-controlled release; remotely regulated, pre-programmed, or self-regulated delivery of nutrients or disease treatments; transplanted cells protected by membranes; bio-separation; and rapid sampling and diagnosis of plant or animal health (Roco 2003; see also Scott and Chen). Nanotechnology may also help make food products cheaper and production more efficient and more sustainable through using less water and chemicals. For example, Indian chemical company Tata Chemicals is developing nanotechnology-based crop-specific, high-value fertilizers to improve agricultural yields (Ghosh 2006). Because of their nanoparticle form, less fertilizer can be used for greater results. Australia’s NanoChem Pty Ltd. has developed a water treatment technology called MesoLite that removes ammonia from waste water and concentrates it into commercial fertilizer (Government of Australia 2006). The ability to manipulate the molecules and the atoms of food could allow the food industry to design food with more precision and help lower costs, claims a study by the Helmut Kaiser Consultancy(). The study argues that foods in the future

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will be designed by shaping molecules and atoms and predicts that nanoscale biotech and nano-bio-info will have a major impact on the food and food-processing industries (FoodProductionDaily.com 2004). However, this could enable developed countries to produce more food, more economically, making them less dependent on cheap agricultural products from developing countries (ETC Group 2004). As noted in the sections below, the corresponding socioeconomic effects on the economies of developing countries could be significant.

13.2

Risks and Cross-Cutting Issues

Nanotechnology products are entering the global marketplace at an increasing pace and strong competitive and economic drivers will likely accelerate this trend, leading some observers to argue that the sheer momentum of efforts to develop nanotechnology could be overwhelming the need to examine and manage associated risks such as near- and long-term socioeconomic disruptions, human health and environmental impacts, and ethical, legal, and trade implications. Participants in GDNP meetings, most recently during the International Workshop on Water, Nanotechnology, and Development, have contributed to the development of a matrix of priority cross-cutting issues, including risk issues. These issues, which are focused on issues at the nexus of nanotechnology and development, are intended to help inform and guide discussions about the potential implications of specific nanotechnology applications; see Fig. 13.1. In this section we define and describe these issues and demonstrate in Fig. 13.2 how the matrix was applied to a specific nanotechnology product during a GDNP meeting.

13.2.1

Environmental, Human Health, and Safety Risks

There is currently slow but growing availability of studies on the environmental, human health, and safety (EHS) impacts of engineered nanomaterials, including data on the toxicity, fate, and transport of nanoparticles. Only a limited number of studies have been published on the potential toxicity of specific nanoscale materials, and the incongruity of results of initial research results demonstrates the complexity of assessing EHS risks. Several fundamental aspects of nanotechnology cause concern that the risks associated with nanomaterials may not be the same as the risks associated with the bulk versions of the same materials. For instance, as a particle decreases in size, a larger proportion of atoms is found at the surface as compared to the inside. Thus, nanoparticles have a much larger surface area per unit mass compared with larger particles. Also, as the size of matter is reduced to tens of nanometers or less, quantum effects can begin to play a role, and these can change optical, magnetic, and electrical properties of materials. Since growth and catalytic chemical reactions occur at

13 Nanotechnology and the Poor Product research & development

Environmental, human health, & safety risks Socio-economic issues

Ethics

Intellectual property rights & access

Public participation & engagement Governance

Capacity building

International collaboration & cooperation Scalability, delivery, & sustainability

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Systematic activities to increase knowledge and apply it to the (further) development of new applications. In the context of the workshop, participants focused on assessing the maturity of specific nanotechnology applications and the steps that would be necessary for further development. Potential harm that may arise from a material, combined with probability of an event (e.g., exposure). In the context of this document, the focus is on potential risks to the environment, human health or worker safety. Impacts on individuals, institutions, or society resulting from a policy or project (e.g., the introduction of a product, of a market intervention) such as price changes, welfare changes, and employment changes. A branch of philosophy concerned with evaluating human action, in particular what is considered right or wrong based on reason. In the context of nanotechnology, ethical questions have focused, for instance, on applications related to human enhancement and performance, privacy questions resulting from research into nanotechnology monitoring systems, and questions about possible malevolent or military uses of nanotechnologies. Intellectual property rights (IPRs) are legal protections for intellectual property claimed by individuals or institutions. Copyrights, patents and trademarks are common mechanisms for protecting intellectual property. IPRs are intended to spur innovation and commercialization, but may limit the ability of individuals and institutions to access technology. Processes that affect whether and how individuals participate in societal discourse, including public information, public education, and public discussion and dialogue regarding nanotechnology. Processes, conventions, and institutions that determine how power is exercised to manage resources and societal interests, how important decisions are made and conflicts resolved, how interactions among and between the key actors in society are organized and structured, and how resources, skills and capabilities are developed and mobilized for reaching desired outcomes. This includes risk governance (i.e., comprehensive assessment and management strategies to cope with risk) and governance for innovation (i.e., programs targeting nanotechnology R&D for public objectives). Using this definition, governments, governmental and intergovernmental institutions, as well as public and private corporations, non-governmental organizations, and informal associations are examples of institutions involved in governance. Assistance provided to develop a certain skill or competence, including policy and legal assistance, institutional development, human resources development, and strengthening of managerial systems. Collaborative partnerships between individuals, and institutions from developed and developing countries at a local, national, regional level on any aspect of nanotechnology. The ability to scale-up production and distribution of products so they reach large numbers of people (i.e., success not limited to pilot projects) and the sustainability of products, which relate to numerous factors including, for example, costs, ease of use, and durability.

Fig. 13.1 Cross-cutting nanotechnology issues

Cross-Cutting Issues Product research & development

Nanoparticle Filter (Indian Institute of Technology and Eureka Forbes) No specific comments on this issue for this technology.

Environmental, human health, & safety risks

1. Laboratory studies have determined that the filter is effective for removing the contaminants of concern, in particular pesticides.

Socio-economic issues

Participants asked whether this technology should be applied up-stream and not just at the point of use of drinking water, for example, to prevent people bathing in pesticide contaminated water.

Ethics

Some participants asked whether, given the potential benefits that would accrue to human health due to the successful removal of pesticides from contaminated groundwater, applications such as this be should pursued or whether regulatory frameworks should be set up first.

Intellectual property rights & access

The technology was patented by IIT and licensed to Eureka Forbes.

Public participation & engagement

• Questions were raised about whether the communities and households that will receive these filters were provided an opportunity to learn about the devices and to choose whether they wish to make use of them above and beyond whatever “social marketing” was undertaken.

Governance

• No specific comments on this issue for this technology; see cross-cutting comments in section above and comments directly above regarding EHS risks and Ethics.

Capacity building

• No specific comments on this issue for this technology; see cross-cutting comments in section above.

International collaboration & cooperation

• See Next Steps section for details related to collaboration and cooperation.

Scalability, delivery, & sustainability

• A factory is currently under development that will produce 40,000 filters per month. • These filters have undergone accelerated testing and have been determined to produce enough drinking water for a household for 1 year, approximately 5,000 l. • The company producing these filters is developing a video to explain use of the technology. • The filter is gravity driven and does not require power. • The filters will cost US$2.90 and the nanomaterial costs US$0.67. • The filter cartridge needs to be replaced once a year. The company producing the filters will replace the filter cartridge as part of its contract with users. • Participants discussed this technology as an example of the potential of public-private partnerships to develop and deploy such technologies. In conjunction, they discussed the need for an NGO partner to distribute and facilitate the use of the technology and the need for social marketing.

2. Laboratory studies by certified third party labs demonstrated that no nanoparticles were found in the filtered water at the limits of detection of existing testing systems and current standards. 3. Participants asked how the spent cartridges will be disposed.6

Fig. 13.2 Example of application of cross-cutting nanotechnology issues matrix 6

Information obtained by Meridian Institute after the workshop indicates that: (1) the filter cartridges will be in the field for a year and replaced, as part of the sales agreement, by Eureka

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surfaces, a given mass of nanomaterials will be more reactive than the same mass of materials made up of larger particles. These properties might have negative health and environmental impacts and may result in greater toxicity of nanomaterials (Bruske-Hohlfeld et al. 2005). The study of nanoparticles’ toxicity is complicated by the fact that they are highly heterogeneous. Not only are they exclusively engineered to specification but in many cases nanoscale materials will alter in physical size upon interaction with aqueous systems. Furthermore, the surface coating of nanoparticles can be altered to completely change the material’s toxicity. For example, changing the surface features of the material can change a hydrophobic particle into a hydrophilic one (Goldman and Coussens 2005). Nanotechnology handlers, consumers, and other people could be exposed to nanoparticles through inhalation, ingestion, skin uptake, and injection of nanoscale materials. Nanoparticles could also interact with ecosystems, animals, plants, and microorganisms.. Furthermore, use of nanomaterials in the environment may result in novel by-products or degradates that also may pose risks. To date, very few ecotoxicity studies with nanomaterials have been conducted. Studies have been conducted on a limited number of nanoscale materials and in a limited number of aquatic species. There have been no chronic or full lifecycle studies reported.

13.2.2

Socioeconomic Issues

Given the potential rapid and radical technology innovations that may be enabled by nanotechnology, some people and publications have expressed concerns that nanotechnology applications could have adverse socioeconomic effects on developing countries (ETC Group 2004). Other people, however, have said nanotechnology applications – as described extensively above – may yield significant economic and social benefits for developing countries. In particular, some people have raised questions about the socioeconomic effects of nanotechnology applications that could impact global demand for agricultural, mineral, and other non-fuel commodities (South Centre 2005). The term “commodities” usually refers to “undifferentiated, widely traded raw materials and agricultural products that are traded principally on the basis of price.” Impacts on commodity markets are important, because 95 of the 141 developing countries derive at least 50% of their export earnings from commodities. In 2003, fifty-four of those countries depended on non-fuel commodities for more than half of their export earnings (e.g., copper and zinc account for 61% of Zambia’s export earnings; cotton makes up 72.7% of Mali’s earnings). UNCTAD estimates that a total

Forbes’ local service units; (2) plastics and the useful metals from the used cartridges will be recycled; (3) the remaining balance of material will be incinerated; material remaining from incineration will be landfilled or used as filler (e.g., in brick manufacturing).

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of two billion people—a third of the global population—are employed in commodity production, half of those in agriculture (United Nations Conference on Trade and Development 2005). Although the exploitation of natural resources may contribute to economic development and enhanced public welfare, many developing countries that are highly dependent on commodity export as a primary source of revenue appear low on the United Nations Development Programme’s Human Development Index. Dependence on revenue from a narrow range of commodities is risky for countries and producers, because they depend on international markets that have shown longterm price declines and sharp short-term price fluctuations. These countries and producers often find themselves with limited access to credit for production inputs, capital for investments, and know how. Nanotechnology applications are being developed that could impact global demand for agricultural, mineral, and other non-fuel commodities. Some applications of nanotechnology could increase global demand, while others could lead to a decrease in demand for specific commodities. Applications that result in reductions or increases in the demand for commodities could have potentially far reaching socio-economic and other effects in developed and developing countries. The dependence of many developing countries on one or two commodities is likely to accentuate the socio-economic effects resulting from changes in commodity markets in comparison to countries with more diversified economic bases.

13.2.3

Ethics

Some people have identified an ethical tension in balancing the urgency of alleviating the critical needs of developing countries with nanotechnology and ensuring that those populations are not exposed to the unknown, but potentially significant, risks posed by those technologies. This ethical dilemma includes questions about whom (e.g., developed or developing country governments, international organizations, civil society, poor people) should make such risk-benefit decisions and what should be their motivation (e.g., economic competitiveness, humanitarianism, modernization). A number of reports have discussed the ethical issues related to nanotechnology and equity. Some have said that past science and technology advances such as vaccines have enabled mass application of solutions to human development needs. But, empirical studies have also shown that introduction of new technologies have resulted in further marginalization of the poor, for instance because the underlying commercial and distribution infrastructure remains in the control of developed countries. Some groups have also argued that the current approach to nanotechnology research and development is overly top-down and does not take into account existing solutions including traditional, alternative, or complementary practices, such as herbal medicine and traditional pest manage-

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ment, despite the cultural significance and an increase in use of these practices in many developing countries.7 The US and European governments and researchers in other developed and developing countries are working, to different extents, on nanotechnology research related to human enhancement and performance. Some groups are now asking about the ethical implications of nanotechnology applications, such as materials that enable bone, tissue, and nerve regeneration, that would benefit disabled people in developed countries, but possibly be unaffordable for those in developing countries. There are also a number of ethical considerations regard nanotechnology’s implications on privacy. Some say that nanoscale information gathering systems such as transmitters could be both ubiquitous and invisible because of their small size. Some say that nanoscale health monitoring devices that could be temporarily or permanently implanted in the body could also have negative privacy implications.

13.2.4

Intellectual Property Rights and Access

Several publications have expressed concerns related to IPRs and the impact of patents and technology management strategies on the ability of developing countries to access new technologies. For example, the potential for broad nanotechnology patents on conventional and natural materials at the nanoscale raises the possibility that such patents could give patent owners excessive control over the use of nanoscale materials. Some groups are urging that the effects of patents, conditions in technology licenses, and impacts of government and corporate policies on people’s ability to use nanotechnology for meeting human development be considered now, even though some of the potential benefits of nanotechnology may be years away. Without this discussion, they argue, the technology will be controlled by developed countries and multinational corporations, primarily benefit consumers in developed countries, and lead to a deepened divide between developed and developing countries.

13.2.5

Public Participation and Engagement

With nanotechnology investments continuing to rise and applications proliferating, awareness and understanding regarding the implications of nanotechnology for developing countries is increasing. However, this awareness is still generally limited – few people involved with nanotechnology are considering development issues; few people involved in the development community are considering the potential role of nanotechnology in addressing humanitarian needs. These gaps 7

Nanomedicine, poverty and development.

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continue to be a significant concern, as current and future decisions in both developed and developing countries may result in policies, practices and systems that can have long-term impacts on whether nanotechnology can help address specific human development needs and, if so, how quickly. More robust mechanisms are needed to engage the public in dialogue about the responsible innovation and governance of nanotechnology.

13.2.6

Governance

The growing realization that nanotechnology applications are already being developed and used in both developed and developing countries is contributing to heightened interest in discussions about the governance of nanotechnology. A small, but growing number of national and international initiatives are addressing components of the issue, yet, there is still significant confusion about what is meant by “governance of nanotechnology”. There are currently a range of opinions on the adequacy of existing systems for governance of nanotechnology versus the need for new nanospecific governance frameworks. Additionally, existing initiatives that are addressing governance are largely taking place in developed countries (national initiatives) or dominated by developed countries (international initiatives). Many commentators feel that North-South communications about nanotechnology risks are weak among scientists and policy makers, as well as among national-level ministries and international institutions. Addressing these challenges will be critical to the development of a governance framework that addresses both opportunities and risks, is broadly supported by all sectors of society, responds to the needs of developing countries, and can inform decision making at national, regional, and international levels.

13.3

Conclusion

While application of nanotechnology is still regarded to be a relatively young scientific discipline, there are already hundreds of products available (with hundreds more in development) to consumers that utilize the novel characteristics of nanotechnology. With strong competitive and economic drivers likely to accelerate this trend, the perception that nanotechnology products were “years away,” which seemed to be the prevailing view only a few years ago, is now being displaced by a growing interest in catalyzing specific actions that support the emergence of creative and appropriate approaches to nanotechnology innovation and governance. Our analysis of the current dynamics and changing landscape of nanotechnology, informed by the GDNP and other processes, leads us to conclude that there is a pressing need for innovative approaches that: enhance the role of developing countries in

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responsible nanotechnology development and governance; encourage the development of appropriate products targeted to help meet critical human development needs; and include methods for addressing the safety, appropriateness, accessibility and sustainability of nanotechnology to meet the needs of developing countries.

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Inframat. 2001. Description of Nanofibrous. MnO2 Bird’s-Nest Superstructure Catalyst. http:// www.inframat.com/cat2.htm. Cited 1 June 2007. Inside Washington Publishers. 2006. BP Sees Potential Breakthroughs In Solar Energy Using Nanotech. Inside Green Business (11 July 2006). Intermediate Technology Development Group. Power to the People. http://www.itdg.org/html/ advocacy/power_to_the_people_paper.htm. Cited 28 November 2004. Los Alamos National Laboratory. Nanoporous Polymers for Water Purification. http://www-emtd. lanl.gov/TD/Remediation/NanoPorousPolymer.html. Cited 4 April 2007. Moldofsky, L. 2004. Biotechnology: Smarter Products with Nanotechnology. Financial Times Australia (28 October 2004). Nano-Fotocide. http://www.fotocide.com/index.html. Cited 1 June 2007. NanoViricides Invited to Vietnam’s Hi Tech Park. Business Wire (21 November 2006). Nanotechnology coating is battling hospital superbugs. Infolink (7 September 2006): http://www. infolink.com.au/articles/FD/0C044BFD.aspx. Cited 1 June 2007. New disease detector wins £826,000 grant. Cambridge Evening News (13 October 2006): http:// www.cambridge-news.co.uk/news/city/2006/10/13/5ab61e1a-086f-404e-8601-675a217dde9e. lpf. Cited 1 June 2007. Pars Environmental, Inc. NanoFe. http://www.parsenviro.com/nanofeaw-1.html. Cited 1 June 2007. Ring, Ed. 2006. Nano-Titanate Car Batteries. EcoWorld (11 September 2006). http://www.ecoworld.com/ blog/2006/09/11/nano-titanate-car-batteries/. Cited 1 June 2007. Roco, M.C. 2003. Nanotechnology: Convergence with modern biology and medicine. Current Opinion in Biotechnology 14: 337–346. Roco, M.C et al., eds. 1999. Visions for Nanotechnology Research and Development in the Next Decade. Interagency Working Group on Nanoscience, Engineering, and Technology, Loyola College, Maryland, September 1999. Section 10. Nanoscale Processes in the Environment. pp. 143–153. http://www.wtec.org/loyola/nano/IWGN.Research.Directions/. Cited 1 June 2007 Rogers, P. 2006. World’s largest solar plant planned in Bay Area. Mercury News (21 June 2006). http://www.nanosolar.com/cache/sjmnwl.htm. Cited 1 June 2007. Roumeliotis, G. 2006. Researchers give ‘one-off vaccines’ a shot. in-Pharma Technologist (20 March 2006): http://www.in-pharmatechnologist.com/news/ ng.asp?id = 66534. Cited 1 June 2007. RPI News and Information. 2004. Efficient Filters Produced from Carbon Nanotubes through Rensselaer Polytechnic Institute–Banaras Hindu University Collaborative Research. 11 August 2004. http://news.rpi.edu/update.do?artcenterkey = 435. Cited 1 June 2007. Salamanca-Buentello, F et al. 2005. Nanotechnology and the Developing World. PLoS Medicine. doi: 10.1371/journal.pmed.0020097. Scott, N and H. Chen. Nanoscale Science and Engineering for Agriculture and Food Systems. Cooperative State Research, Education and Extension Service, US Department of Agriculture. Singh, K.A. 12 January 2007. Intellectual Property in the Nanotechnology Economy. Nanoforum. http://www.nanoforum.org/. Cited 1 June 2007. South Centre. 2005. The Potential Impacts of Nano-Scale Technologies on Commodity Markets: The Implications for Commodity Dependent Developing Countries. Geneva, Switzerland. Srivastava, A et al. 2004. Carbon nanotube filters. Nature Materials 3: 610–614. UN Conference on Trade and Development. 2005. Trends in World Commodity Trade, Enhancing Africa’s Competitiveness and Generating Development Gains. Report by the UNCTAD secretariat for the 2nd Extraordinary Session of the Conference of African Union Ministers of Trade, 21–24 November, 2005, Arusha, Tanzania. UN Millennium Project. 2004. Forging Ahead: Technological Innovation and the Millennium Development Goals. Task Force on Science, Technology, and Innovation. 8 November 2004. http://www.cid.harvard.edu/cidtech/TF10Edit11-8.pdf. Cited 1 June 2007. UN Millennium Project. 2005. Innovation: Applying Knowledge in Development. Task Force on Science, Technology, and Innovation. http://www.unmillenniumproject.org/ reports/reports2.htm. Cited 1 June 2007.

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Chapter 14

Cultural Diversity in Nanotechnology Ethics1 Joachim Schummer

14.1

Introduction

Within the space of less than a decade, nanotechnology has emerged as a major technological theme not only across most of the science and engineering disciplines, but also across most of the world, including in many developing countries in Asia, South America, and Africa. Because they have identified great economic potential, or simply because they have not wanted to lag behind, governments around the globe have launched nanotechnology programs and initiatives and promoted nanobusiness alliances to harvest the fruits of the “next industrial revolution”. This perhaps unprecedented global technological movement has been fostered by exaggerated promises that nanotechnology will fundamentally change society, that it will bring the wealth, health, clean environment and security of which we have all dreamt. At the same time, however, warning voices have argued that such a powerful technology could also bring about unparalleled harm to the world, from environmental hazards to the destruction of all life. And so the ethicists and philosophers have been called in. My involvement in discussions of the ethical and societal implications of nanotechnology has been developing since 2002, through attending and organizing conferences that have grown rapidly from small-scale meetings to large international events, and through sitting on boards and expert groups to advise others on these matters. There is little doubt that ethical reflection has been unable to keep up with the pace of globalization of the nanotechnology movement. Unlike research in nanotechnology, perception of ethical issues surrounding nanotechnology is influenced by the specificities of cultural background, to the extent that, for instance, some countries heavily involved in research do not see any such issues at all. All this causes misunderstandings and contributes to the reinforcement of cultural clichés, which need to be overcome by in-depth discussion. As nanotechnology turns global,

1

This paper was first published in Interdisciplinary Science Reviews, 31 (2006), 217–230; reproduced with permission from Maney Publishing. An earlier draft was presented at the Chinese–German Symposium on Ethics of Science and Technology held in Dalian, China on 17–22 July 2005.

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with prospective global impacts, both positive and negative, the globalization of the ethical debate around nanotechnology becomes ever more important. In order to facilitate such debate I try here to bring into systematic form my own personal experience, from numerous international discussions, of the cultural diversity of perceptions of ethical issues related to nanotechnology. Rather than providing personal anecdotes or hermeneutical studies of this or that culture, I investigate various ways in which perception of ethical issues can differ. Such a philosophical approach requires that concepts are both broad enough to embrace the cultural diversity, and clear enough for conclusions to be drawn. Thus, by “perception of ethical issues of technology” I mean perception of conflicts with one’s individual moral intuition or with the moral order of one’s society that might be caused by a given technology in the present, past or future. (Note that this is different from the much-discussed perception of risks.) Furthermore, by “technology” I mean not only actual or possible technological products, but also associated technological knowledge, manufacturing processes from laboratory to industrial scale, and research and development activities (R&D) including the control mechanisms that govern them. As with any philosophical analysis, my analysis of cultural conditions takes apart what is in reality interwoven in any given culture. Indeed, I will analyze separately five dimensions of cultural conditions, namely language, cultural heritage, economy, politics, and ethics. For the purpose of my main argument the analytical distinction does not matter, however, because my aim is to illustrate and to help understand the rich diversity of ethical issues that can be perceived, depending on one’s cultural background. Ultimately, cultural diversity poses the question of ethical relativism in engineering ethics, in other words whether different ethical standpoints are irreconcilable on a fundamental level, a position I will finally reject.

14.2

Linguistic Conditions: Definitions of Nanotechnology

As with most ethical issues, the perception of ethical issues surrounding nanotechnology has an essential dependence on the definition of crucial concepts. While some concepts may be defined on a cross-cultural scientific basis with high precision, for example concepts related to scientific measurement, others resist such an approach, remaining unfocused and context-dependent, such that cross-cultural translation becomes virtually impossible. Despite using the same, or a literally translated, term, people from different cultures read in different meanings that may result in different perceptions of ethical issues. In the present context, the most problematic term is “nanotechnology” itself. Definitions are vague, and there is no general agreement on what nanotechnology is. Different communities, disciplines, and countries use different concepts, which are in turn under continuous revision. Note that the mere fact of a vaguely defined technology, which is at the same time said to have huge impacts on society, may

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already shape the perception of ethical issues, as it allows space for projecting personal fears, suspicions and hopes onto the unknown. Among current definitional approaches, three types prevail. First, there are what philosophers call nominal definitions, i.e. defining a term against necessary and sufficient conditions. The most common of these define nanotechnology as the investigation and manipulation of material objects in the 1–100 nm range, in order to explore novel properties and to develop new devices and functionalities that essentially depend on that 1–100 nm range. Whether intentionally or not, this definition covers all classical natural science and engineering disciplines that investigate and manipulate material objects, including chemistry, materials science, solid state physics, pharmacology, molecular biology and chemical, mechanical and electrical engineering. This is because almost any material is structured in the 1–100 nm range in such a way that its structure in this range determines properties and (technologically speaking) functionalities (Schummer, 2004a). If you stick to such a definition, you will perceive no new ethical issues simply because there is nothing new about nanotechnology other than the term. It is according to this definition that researchers from across the board of science and engineering disciplines are currently relabeling their research “nano-”, because it helps them raise funding, and rightly so. The second definitional approach, also known as real definition, refers to a list of particular cases of current research topics. Such lists typically include scanning probe microscopy, nanoparticle research, nanostructured materials, polymers and composites, ultra-thin coatings, heterogeneous catalysis, supramolecular chemistry, molecular electronics, molecular modeling, lithography for the production of integrated circuits, semiconductor research and quantum dots, quantum computing, MEMS (micro-electro-mechanical systems), liquid crystals, small LEDs, solar cells, hydrogen storage systems, biochemical sensors, targeted drug delivery, molecular biotechnology, genetic engineering, neurophysiology, tissue engineering, and so on. Unrelated as these research topics are, apart from their common topicality, it would be more appropriate to speak of “nanotechnologies” (plural) than of a single “nanotechnology”, particularly because there is, contrary to many claims and hopes, no particular interdisciplinary collaboration (Schummer 2004b). From an ethical perspective, it is difficult to identify any one possible issue that would equally apply to all these research fields. So sticking to this second type of definition, one’s perception of ethical issues of nanotechnology essentially depends on what is included in the list. Since the list varies from country to country, even from research community to research community, and since it changes over time, perceptions of ethical issues are bound to change accordingly. Moreover, because this type of definition lumps together what are otherwise unrelated fields, personal fears and hopes about one technology may spread over and contaminate all other nanotechnologies without reason. The third definitional approach, teleological definition, defines nanotechnology in terms of future goals. To be specific, one needs to provide more than just generic values, such as health, wealth, security and so on, and more than just relative attributes like smaller, faster, harder, and cheaper. Since their introduction by Eric

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Drexler 20 years ago, teleological definitions of nanotechnology have developed into visions of a futuristic technology that will radically change everything, from industrial production to the somatic, psychological and social conditions of human life (Drexler, 1986). According to this approach, current research belongs to nanotechnology if it helps realize a nanotechnological future in which these prospective goals will be achieved. Numerous such visions are in circulation, particularly in the US but more recently also in Europe. Besides Drexler and many other software engineers, who dominate the popular book market on nanotechnology with their fantastic visions of nanorobots that can do anything, from gaining immortality to totally destroying intelligent life, there is a proliferating nanoscience fiction field that essentially inspires them (Schummer 2005). In addition, the US administration has assumed its own nanotechnological visions, from the Drexler-like “shaping the world atom by atom”2 to transhumanist visions of the “convergence of nanotechnology with biotechnology, information technology, and cognitive science” for the enhancement of human intelligence and physical performance (Roco and Bainbridge, 2002). If you stick to teleological definitions, ethical issues of nanotechnology immediately arise. Because goals are normative concepts, i.e. they prescribe what kind of technology should be developed, the entire discussion about nanotechnology in terms of teleological definitions is actually a hidden normative debate about norms and values that are frequently expressed in the form of hopes and fears. Moreover, if one believes that normative debates should be conducted explicitly and deliberately in public discourse, the teleological approach to defining nanotechnology taken by governments and others is already an ethical issue because it smuggles in values in the disguise of definitions or forecasts of allegedly deterministic technological developments, which are kept apart from normative debates. However one defines or avoids defining nanotechnology fundamentally shapes one’s perception of related ethical issues. The scope of ethical perceptions ranges from vague fears and hopes, to no new ethical issues at all, to very particular ethical issues and basic questions about technology governance. The definitional conditions of perceiving ethical issues of nanotechnology discussed thus far go beyond the level of cultural distinctions and may readily apply to the views of different individuals from the same culture. There is some evidence, however, that certain countries favor different definitional approaches and different definitions than others. For instance, in the US the teleological approach along with a vague nominal definition has become prevalent in public discourse, because it resonates with the religious tradition (see below), is easier to communicate to a broader public without much scientific literacy, and avoids an explicit discourse about norms and values of technology. In Japan, where nanotechnology started with the Atom Technology Project in the 1990s as an effort to fund so-called fundamental research, and where critical public attitudes towards technology are

2

National Science Technology Council, 1999. For an analysis of the underlying worldview, see Nordmann, 2004.

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rare, the real definitional approach seems more significant, with a list of research topics that has been continuously revised and that differs from the nanotechnology funding lists of other countries (Fujita, 2005). In general, since “nanotechnology” does not denote an established research field but is rather a term used by governments to describe their research funding priorities, definitions may be tailored so as to cope with the ethical sensitivities of their publics, which itself may already be perceived as an ethical issue. At this point one might become doubtful of the sense of discussing ethical issues related to nanotechnology at all. On the one hand, discussion of such issues requires clarification of the term’s meaning to ensure that we are speaking about the same thing; on the other, any such definitional clarification already shapes the perception of ethical issues almost at will. There seems to be no way to escape this circle other than giving up the idea that nanotechnology (singular) can be defined in a meaningful way to discuss specific ethical issues of that technology. It would be more reasonable to identify ethical issues by scrutinizing each of the individual technologies that are more or less loosely associated with nanotechnology (Moor and Weckert, 2004; Gordijn, 2005; Schummer, 2007a). However, the perception of ethical issues related to an individual technology may be affected even by its loose association with nanotechnology, since many issues of public concern are related to the novelty of technological products that provokes uncertainty and fear of risks. If nanotechnology is propagated through its novelty, as being “the next industrial revolution” as the US National Nanotechnology Initiative has claimed since its launch in 2000 (White House, 2000), any technological product associated with nanotechnology may be supposed to bear new kinds of risks and to require new regimes of evaluation. If, on the other hand, nanotechnology is (according to the nominal definition) considered to be simply a new term for received technologies, then any new technological product associated with nanotechnology may be considered the result of continuous development, and likely to be well covered by existing regulatory regimes. Mere association with “nanotechnology” thus affects evaluation of the novelty of a product, and thereby the decision whether old or new evaluation regimes need to be applied. A good case in point are nanoparticles. It has been known empirically for centuries, and to a degree understood by quantum mechanics, that the electromagnetic, chemical, and catalytic properties of nanoparticles of the same composition can vary with the size and shape of particles in the nanometer scale. In this regard, recently increasing research in nanoparticles belongs to a continuing tradition. What is new, however, is the systematic development and large-scale industrial production of nanoparticles (and nanostructured materials with nanoparticle abrasion) for specific uses. Increased exposure to manufactured nanoparticles poses new health and environmental risks, because their size-dependent properties and potential toxicity are unknown, and because below a certain size they can permeate biological membranes. Thus far no country worldwide has a regulatory regime for nanoparticles, but instead use of materials continues to be controlled only according to their composition, thus expressly disregarding particle size. Therefore, emphasizing the novelty of nanoparticles through the novelty of nanotechnology not only brings

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greater awareness of risks. It also raises ethical concerns that current regulations are insufficient and that we need to develop a new regime for nanoparticles.

14.3

Cultural Heritage

Perception of the ethical implications of nanotechnology, or of any technology for that matter, also depends on culturally embedded sensitivities, symbolic meanings, and religious or literary myths specific to a particular culture. Depending on how the new technology is framed (see above), it may trigger memories of past issues and myths and provoke judgment by analogy or stereotype. Unlike the ideal of philosophical ethics, public perception and debate around ethical issues is dominated by such culture-specific responses. While examples from nanotechnology abound, I will focus specifically on a comparison of Western European and US perspectives. In Western Europe, for example, the Christian idea of an artisan-like creator-God has always provoked stereotypical criticism of technology. As soon as nanotechnology is framed in terms of “reshaping nature atom by atom”, it can readily be accused of hubris (playing God) and destroying nature (changing God’s creation against God’s will), two concerns that have accompanied chemical craft and science since antiquity and eventually inspired the literary motif of the “mad scientist” (Schummer 2003, 2006a; Newman 2004). In the US, where Christian religion is much more focused on the “end times”, nanotechnology is rather viewed as the dawn of the “Golden Age”, the “Apocalyptic destruction”, or both (Schummer, 2006b). If even Europeans and US-Americans, despite their common religious roots, differ considerably in their religion-based perception of ethical issues of nanotechnology, the cultural diversity worldwide is likely to be substantial. Apart from religion, cultural traditions and particular events in the more recent history of a culture can inform specific sensitivities. For instance, as a result of their Nazi legacy, Germans are particularly sensitive to any approach that could be used or abused for eugenic purposes. From this point of view, the mere notion of “human enhancement”, which the US government has made one of its primary goals for nanobiotechnology and in which the military has a vested interest, is not only suspicious but also strongly abhorrent. Similarly, from a pacifist point of view, which still pervades countries that experienced two world wars on their own territory, any nanotechnological research for weapons development appears morally questionable, because weapons are made for destructive purposes and/or may cause another arms race. In the US, on the other hand, where a large part of the federal budget for nanotechnology R&D has gone to the Department of Defense, the vast majority of people takes great pride in the strength of the military and thus support weapons research. Support has even increased since the 9/11 terrorist attacks, so long as such research is said to strengthen “homeland security”. However, the same event has also caused tremendous fear of any terrorist abuse of technology, which has become a main focus in the American perception of ethical issues surrounding

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nanotechnology and which is additionally inspired by the proliferating nano-science fiction field. Societies also differ greatly in their normative ideas about human identity and integrity, putting different weight on different aspects of human existence, and accordingly their perceptions of ethical issues of nanotechnology differ. For instance, US policy-makers foresee particular societal concerns in the “use of nanotechnology in enhancing human intelligence and in developing artificial intelligence which exceeds human capacity” (21st Century Nanotechnology Research and Development Act, 2003). The underlying assumption here seems to be that US-Americans, perhaps more so than Europeans, identify themselves with machine-like “intelligence” operations of their brains that can be enhanced by IT. Any improvement of that operational capacity would change the identity and thus affect the integrity of human beings. Moreover, a machine that is better at these operations than human beings could undermine human self-esteem, if not dignity, and cause fears of loss of control. On the other hand, if one considers such operational capacities only an instrumental rather than an integral part of human beings, and bases human identity and integrity instead on moral, social and other mental capacities (such as free will), as European philosophers of the Enlightenment did, these concerns are less important. Another normative idea concerning the integrity of human beings is individual privacy, according to which a private sphere needs to be protected from public access. In any society, privacy is codified in laws and taboos, but the differences are surprisingly large even among European countries. For instance, Germans treat their salary like a private secret, whereas in Scandinavian countries the complete tax return of every citizen is displayed in public libraries. By contrast, both in Germany and Scandinavian countries, public nudity on nudist beaches is commonly accepted, whereas this would seriously breach a privacy taboo in many other European countries, like, for instance, England. England, in turn, stands out for first introducing surveillance cameras in public spaces, which in other European countries would be considered a violation of privacy rights. These examples illustrate that, although each culture clearly has a normative idea of privacy, the specific aspects of the private sphere that need to be protected vary enormously even within Europe, and much more so worldwide. One of the current promises of nanotechnology is that it will provide ultrasmall sensors, computing and signal transmission devices. This puts the current privacy debate about macroscale radio-frequency identification devices (RFIDs) and ubiquitous computing on a new level, because the devices might be too small to be detected by the naked eye and thus invade private spheres much more easily than before. Because of the wide cultural diversity in notions of privacy, perception of privacy issues around nanotechnology may also be expected to be culturally very diverse. Finally, owing to the vagueness of definitions, nanotechnology is an excellent candidate for loading with culture-specific symbolic values, such that it stands for something else that is considered intrinsically good or bad. Examples of objects loaded with culture-specific symbolic values are social prestige objects that stand

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for social status and are thus highly valued independent of their instrumental value. Indeed, like the Apollo program and other technological prestige projects during the Cold War, the US government has already symbolically loaded nanotechnology. Whatever it is, nanotechnology is something in which the US must have “global leadership”.3 Once nanotechnology is made a national prestige object, the perception of ethical issues changes because it stands for something that is considered intrinsically good, such that any criticism would seem to undermine the cultural basis of values. There is some evidence that nanotechnology is also becoming a national prestige object in other countries, including fast developing ones like South Korea and China, where efforts in nanotechnology R&D are intended to catch up with the West.4 A likely problem for rapidly developing countries is that nanotechnology may become a symbol of (Western) modernism, and thus a symbolic target for traditionalist critiques. If nanotechnology, as so many other technologies before, becomes a proxy on which the modernism/traditionalism conflict is debated in developing countries, that will radically affect the perception of ethical issues of nanotechnology there.

14.4

Economic Conditions

The perception of the ethical implications of nanotechnology also depends on the economic situation of a given country. If nanotechnology is considered as enabling “the next industrial revolution”, i.e. as providing a unique opportunity for huge economic improvement, no country wants to lag behind, naturally. Thus the economic promise puts enormous pressure on suppressing or at least outweighing ethical issues, both in developing and developed countries. However, there are some important differences between these two situations. In many developed countries, a large part of private investment in R&D for new technologies comes from venture capital, i.e. from individuals or investment funds that seek potentially very high interest rates in risky investments. If the venture capital market also allows for bets on losses, i.e. if money can be made from falling prices, fluctuations tend to be very high. The two recent examples of venture-capital sponsored technologies, internet technology and biotechnology, illustrate that the venture capital market, with its associated media, is prone to extreme exaggeration of both positive and negative prospects for new technologies in two separate phases. In the first phase, the “bull market” or “bubble creation”, the new technology is promised to enable “the next industrial revolution”, leading to astronomical growth rates. In this phase any negative information, including ethical concerns, is largely

3

From the launch of the US National Nanotechnology Initiative to the 21st Century Nanotechnology Research and Development Act (Sec. 2), “ensuring United States global leadership” has been a primary concern. 4 For quantitative studies, see Kostoff et al. (2006) and Schummer (2007b).

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suppressed. As a result of any incident, the first phase can abruptly turn into the second phase, the “bear market” or the “burst bubble”, in which prices immediately drop and in which any negative news, including ethical concerns, is eagerly embraced and exaggerated in the media. For venture capitalists, nanotechnology is currently in the first phase. And because information about nanotechnology is drawn mostly from business magazines and newspaper business sections, the public perception of ethical issues of technology in developed countries is strongly influenced by the interests of the venture capital market.5 For developing countries, being part of “the next industrial revolution” from the outset offers a unique opportunity to catch up economically. It is much easier to start out in a new market than to compete in traditional industrial markets where the R&D gap is big and where global companies are already established and have protected their research and products by broad patenting strategies. Because of the supposedly unique situation, it is likely that developing countries will tend to neglect ethical issues of nanotechnology, on the basis that they will be outweighed by the extraordinary economic benefit of an early and unhindered R&D effort. There are at least two ethical issues related to nanotechnology, however, that might be more readily perceived in developing than in developed countries, because they reflect issues of equity in a globalize market. First, the rise in fortunes of all the research fields mentioned above in discussing the “real” definition of nanotechnology began at a time when patent policies drastically changed in the Western world, first in the US with the 1980 Bayh-Dole Act and more recently in Europe. Since universities have been allowed to file and market their own patents, much of the kind of knowledge that was formerly in the public domain, including basic engineering knowledge, is now protected by patents. The large-scale shift from public to private knowledge considerably increases the costs of industrial R&D that builds on existing knowledge, which must now often be bought through licenses. While this of course affects industrial research in any country, it particularly increases the knowledge gap between rich countries and poorer ones that cannot afford the license fees. Because R&D expenditures are usually much higher in richer countries, nanotechnology (under the real definition) may be expected to increase the economic gap between rich and poor countries much more than any previous technology. The second issue is even less obvious because we tend to associate nanotechnology with small things. On an industrial world market scale, however, small things easily sum up to hundreds or thousands of metric tons of materials per year, with materials prices of millions to billions of dollars. Since raw material resources that need to be mined, particularly metals, happen to lie mostly in developing countries, any change in materials demand on the world market would have its most pronounced effects on the economies of these countries. Many of the research fields listed in real definitions of nanotechnology have the potential to change world metals

5 Schummer, 2004c (reprinted in Nanotechnology Challenges: Implication for Philosophy, Ethics and Society, eds. Schummer and Baird, 413–449, Singapore: World Scientific, 2006).

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markets. For instance, catalysis research could, and deliberately should, lead to substitutes for platinum and palladium that are almost entirely mined and produced in South Africa at a value of several billion dollars per year. Nanostructured ceramics are about to replace much of the current tungsten (nitride), mainly produced in China at $350 million per year. Organic semiconductors could replace many of the classical semiconductor elements such as gallium, germanium, selenium, cadmium, etc. There are many more examples which suggest that much of current nanotechnology, particularly nanostructured materials, could continue a long-term trend in making industrialized countries independent of the resources of developing countries, thus increasing the economic gap. In countries whose economies depend on the export of raw materials, people are more likely to perceive this as an ethical issue of nanotechnology.

14.5

Political Conditions

Because politics is a very complex field, I focus here on only two aspects of how the political conditions in a country can influence the perception of ethical issues of nanotechnology by its citizens: the form of technology governance, and its relation to the general political system. Technology governance is the political control of technological development, including the whole sphere of political instruments from governmental R&D programs and institutes, to subsidized industries, to restrictive regulation. With some simplification, we can distinguish between three models of technology governance according to different kinds of citizen involvement. In the autocratic model, decisions on technology governance are made autocratically, either by governments (political leaders or bureaucratic administrations) or by corporations, without provision of public information about the technology and its positive and negative impacts on society. In such cases the perception of ethical issues tends to be low, owing to the lack of information, and stereotypical according to general attitudes. The perception is different, however, if the autocratic model applies only to a subset of R&D activities that are intentionally kept secret in the name of the national interest. This includes R&D that is said to serve the military, intelligence agencies, “homeland security” or other political institutions that are excluded from the usual public checks and balances. Because secrecy raises suspicion and mistrust, it inspires the imagination and encourages rumors about fantastically powerful technologies of the greatest ethical concern. In the information-plus-debate model, public information, including educational programs and public spaces for debate, are provided on all R&D activities. This certainly helps avoid the suspicion and concerns raised by secret R&D. However, as many studies in the public understanding of science have demonstrated, information about science and technology does not simply dispel ethical concerns, at least in democratic countries. Instead, information helps concerns to be formulated more specifically and public debates help sharpen the arguments, while general attitudes

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towards technology continue to determine the degree of concern and criticism. Confronted with new technologies on the market, critical citizens can protest only by refusing to buy or consume their products. The democratic model involves citizens from the very beginning in the political decision-making processes that shape future technologies. This model has learnt the lesson that people who perceive ethical issues around new technologies are more likely to accept them if they see themselves as part of the technology governance process. The step from being informed and discussing the issues to being involved in the political decision-making procedure moves individuals from a passive to an active role, which implies three important changes. Being able to make a decision requires, first, that there are real options to decide between, which may include various forms or variations of the technology in question, beyond a mere yes or no – thus the citizen decision-maker actually helps form an acceptable technology and so has little reason to mistrust technology governance. Second, it requires that for each option the various pros and cons are compared, putting specific ethical concerns in a wider context of ethical and political deliberations. Third, it requires responsibility towards society, such that in time critical questions can be answered and decisions defended. In sum, a political system that allows citizens in one way or another to participate actively in technology governance does not dispel ethical issues of new technologies, but rather incorporates them into the shaping of technologies. The perception of ethical issues thus becomes part of a politically responsible activity. If one considers the extent of secret military and corporate research in nanotechnology, most countries in fact have some mix of the autocratic model and the information-plus-debate model, and differ only in the degree of public information and debate. Indeed, many Western countries have established governmental technology assessment bureaus that, in addition to advising governments and administrations, try to inform the public about new or recent technologies. All in all, however, political conditions within the scope of the two models seem to affect the perception of ethical issues of nanotechnology only to the extent that concerns are more or less specific and supported by argument, depending on the level of public information and debate on nanotechnology, which is still low in all countries. There is one other political dimension that affects the perception of ethical issues of nanotechnology. Countries differ in their general political cultures and systems. Provided that citizens trust their general political system, any form of technology governance that does not fit the general political system may cause mistrust. Thus, citizens in a strongly democratic system would mistrust the autocratic model of technology governance, and vice versa. Moreover, societies differ in the degree of desired political regulation. Some countries prefer less political control and planning, relying more on free market control. For such countries both autocratic and democratic models of technology governance would be foreign, whereas the information-plus-debate model that educates informed consumers would appear more suitable. Other countries trust more in the efficacy of political control and advance planning, for which the autocratic or democratic models of technology governance would be more suitable than the information-plus-debate model.

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In every country I know of, nanotechnology programs have been launched by government decree, with little prior public involvement or debate on the utility of such a program and of nanotechnology in general. In the US, where the launch of huge research programs has a long tradition dating back to the Manhattan Project, the parallel start of an information-plus-debate program meets general political expectations by preparing the way for the preferred free-market control by informed consumers. In many Western European countries with less trust in freemarket control, the autocratic launch along with the information-plus-debate model cannot substitute for the democratic model of technology governance. Indeed, democratic models of citizen involvement from the earliest stage on have been developed in various European countries, for example “consensus conferences”, “constructive technology assessment”, and “upstream technology assessment” (Joss and Durant, 1995; Rip et al., 1995; Wilsdon and Willis, 2004). Thus, for many Europeans, particularly for political ethicists, the undemocratic governance of nanotechnology is a big ethical issue because it fails to fit their general ideas of a just political system.

14.6

Ethical Framework

Of course it is tautological that one’s ethical standpoint influences one’s perception of ethical issues. From that one might readily find support for ethical relativism. However, as promised in the introduction, I will not defend radical ethical relativism. Instead I will argue that small differences, both in definitions of ethically relevant concepts and in relative weighting of values, may be sufficient to generate widely differing perceptions of ethical issues of nanotechnology. Basic ethical concepts that impact on the perception of ethical issues are normative concepts, such as human integrity and privacy discussed above. The most general, however, is the concept of a good life. I assume all cultures have such a concept, though they may differ in the detail of what it involves. For instance, they may all include some ideas about physical, mental, and social well-being and health, but differ with regard to the relative weights given to these three components. While traditional cultures put more weight on social well-being, modern individualist cultures tend to neglect that in favor of physical and mental health. Moreover, each of the three components may have slightly different meanings in different cultures. For instance the notion of mental health and well-being may cover various mental capacities, for example intellectual, emotional, aesthetic, social and moral. Again, cultures differ in the emphasis they lay on each of these components. While one culture might define mental health primarily in terms of intellectual performance, another will put more weight on social and emotional capacities, and so on. If nanotechnology is, like other technologies, a means of improving conditions for a good life, then it does so only with regard to specific aspects of the concept of a good life. These aspects may be valued per se in every culture, but since

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different cultures put different relative weights on them, what is considered a major improvement in one culture will be less important in another. Moreover, an improvement in one aspect could be at the expense of other aspects. For instance, improving physical health to the extent of prolonging life by nanobiotechnology could simply increase the rate of mental disorder through the dementia of life-prolonged patients; it could also undermine traditional strategies for social well-being, from social relationships between generations to systems of social insurance. Or, improving intellectual performance through nanotechnological devices could go at the expense of other mental capacities. Thus, what might be considered an improvement in one culture could in another raise concerns and be perceived as an ethical issue of nanotechnology, because of different underlying concepts of a good life. The general issue here is that, even if all cultures hold the same values, they may put different relative weights upon these values and thus draw different ethical conclusions. Some values are antagonistic to one another in the sense that pursuing one usually has negative effect with regard to the other. For instance, security and liberty are antagonistic because increasing the security of citizens usually restricts their liberty, and increasing liberty weakens security. As a result, each culture needs to find a balance between security and liberty that depends on the relative weight put on these values. If nanotechnology will help increase security, say by new surveillance and control systems or by portable medical systems that monitor and control health, it will at the same time weaken liberty. Some cultures might embrace these developments, others will not. Some values are not strictly antagonistic but can nevertheless be in conflict. Increasing wealth as a means of improving conditions of life has environmental costs if it is achieved by industrial production that consumes resources, generates pollution, and accumulates waste – and here industrial nanotechnology production will be no exception, of course. Depending on how much the natural environment is valued in a culture, and on what the other options to nanotechnology production are, this might be perceived as an important ethical issue or not.6 Similarly, the values of utility and (distributive) justice can easily come into conflict through new technologies.7 A technology that unquestionably improves the conditions of life of individuals could at the same time increase inequality among the general population, because for various reasons the benefits are not justly distributed. For instance, a nanobiotechnology-based medical treatment could be so expensive that only the economic elite can afford it; or the beneficial use of a nanotechnology-based device may require considerable knowledge skills so that in practice only the educational elite can benefit from it. Cultures that value justice over utility will certainly raise ethical concerns about the injustice induced by the new technology. Others that put a lower value on justice, or have a different concept

6

Preston, 2004 (reprinted in Nanotechnology Challenges: Implication for Philosophy, Ethics and Society, eds. Schummer and Baird, 217–248, Singapore: World Scientific, 2006). 7 Lewenstein, 2004 (reprinted in Nanotechnology Challenges: Implication for Philosophy, Ethics and Society, eds. Schummer and Baird, 201–216, Singapore: World Scientific, 2006).

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of justice, will embrace the technology without much hesitation. Cultures with a still lower evaluation of justice would perhaps accept the technology even if it posed unequally distributed risks, such that it benefited a fraction of society and harmed another fraction, so long as the benefits overall outweighed the harms.

14.7

Conclusion: Cultural Diversity without Ethical Relativism

Each of the five dimensions of cultural conditions discussed in this paper (language, cultural heritage, economy, politics, ethics) entails a large variety of different perceptions of ethical issues. Overall, the scope ranges from no issue at all, to very specific issues, to general concerns and hysteria. In discussions about nanotechnology over the past 4 years I have met all these views, and many more that I omit for reasons of brevity. Although the five-dimensional scheme allows the dominant perceptions to be located in various cultures, there may be a great variety of perspectives even within one country. Whether or not this is a result of globalization or the trend towards multicultural societies, it allows for improved ethical understanding of the other because probably no one view is entirely foreign to any given society. Since my five-dimensional scheme points to cultural differences rather than to the common grounding of ethical views, I may appear to be arguing for ethical relativism. In the common-sense understanding, “ethical relativism” means that individuals and/or cultures differ in their ethical views such that they make different moral statements on particular cases. This is trivially true, because it is in fact the case—otherwise there would be no moral debate. In philosophy, however, “ethical relativism” implies that individuals and/or cultures differ in their fundamental ethical views, such that even perfect information about all details of a case and a uniform understanding of all concepts involved cannot settle their moral conflict. Because only few of the cultural conditions I have analyzed refer to differences in information and conceptual understanding, it seems that this paper has made a case for that kind of ethical relativism. In cross-cultural ethical debates, ethical relativism is a frustrating dead-end. All one is left to do is analyze a conflict down to the “fundamental” level, and then point out the irreconcilable differences. Numerous debates on human rights and in medical ethics have finished like that, and I have no desire to repeat that experience in engineering ethics in the face of increasingly globalize technologies. Beyond being practically fruitless, the philosophical idea of ethical relativism is also a misleading concept because it is based on four problematic assumptions about the ethical views of human beings, as follows. First, ethical relativism assumes that our ethical views are organized in an axiomatic manner such that they are all based on fixed sets of “fundamental ethical views” on which people can differ. While the axiomatic ideal of ethics might be appealing to mathematical reasoning, it has little evidence in support and has therefore been criticized by philosophers ever since Aristotle. In this paper, I have argued for

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an entirely different view. Instead of an axiomatic order, there are various dimensions of cultural conditions that shape our ethical views. These dimensions are to some degree independent of each other, and we do not even know how they interact to form ethical views. Second, even if we take the values discussed above as ethical “fundamentals”, differences arise not because people hold different values, but because they weigh these values differently; and the balance of values may change not only from culture to culture, but also from time to time and from case to case, depending on other factors involved. Third, the clear-cut distinction between ethical views and descriptive information and concepts, which underlies the idea of ethical relativism, is questionable. Concepts are normatively loaded in subtle ways, as I have illustrated in several examples, and thus are an integral part of our ethical views. Finally, and most importantly, human beings are not as static as ethical systems in philosophy, which ethical relativism presupposes. Their ethical views can change and grow. Understanding the cultural conditions of my own ethical views can help me develop a more reflective view. Discussing ethical issues with people from different cultures not only provides information. It can also help me see new normative aspects or let me value some normative aspects differently. International discussion of ethical issues of nanotechnology is an excellent and important exercise, not only because views on nanotechnology are so diverse, but also because nanotechnology is frequently attached to a particularly strong and naive attitude of “improving the world”. International discussions can help us understand that our notions of both “improvement” and “the world” are very complex, culturally diverse and under continuous revision. If such discussions do not reach perfect agreement, we need not resort to ethical relativism, but recognize that people put different weight on different factors. And since nanotechnology is not monolithic, but a bunch of very diverse technologies in the making, societies still have a chance to shape their development according to their own specific societal needs and ethical views.8

References 21st Century Nanotechnology Research and Development Act. Washington, DC, December 2003, Sec. 2, b.10. Drexler, K.E. 1986. Engines of Creation: The Coming Era of Nanotechnology. New York: Anchor Press/Doubleday. Fujita, Y. 2005. Heterogeneous scientists meet in the national lab: The Atom Technology Project in 1990s Japan. Unpublished paper presented at the conference Nano before There Was Nano: Historical Perspectives on the Constituent Communities of Nanotechnology, Chemical Heritage Foundation, Philadelphia, PA, March 2005.

8

For such an approach tailored to the needs of developing countries, see Salamanca-Buentello et al., 2005. For a critical discussion, see Schummer (2008).

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Gordijn, B. 2005. Nanoethics: From apocalyptic nightmares and utopian dreams towards a more balanced view. Science and Engineering Ethics 11: 521–533 Joss, S. and J. Durant, eds. 1995. Public Participation in Science: The Role of Consensus Conferences in Europe. London: Science Museum. Kostoff, R.N et al. 2006. The structure and infrastructure of the global nanotechnology literature. Journal of Nanoparticle Research 8: 301–321. Lewenstein, B.V. 2004. What counts as a “social and ethical issue” in nanotechnology? Hyle: International Journal of Philosophy of Chemistry 10: 5–18. Moor, J.H. and J. Weckert. 2004. Nanoethics: Assessing the nanoscale from an ethical point of view. In Discovering the Nanoscale, eds. D. Baird, A. Nordmann and J. Schummer, 301–310. Amsterdam, NH: IOS Press. National Science Technology Council. 1999. Nanotechnology: Shaping the World Atom by Atom, Washington, DC. Newman, W.R. 2004. Promethean Ambitions: Alchemy and the Quest to Perfect Nature. Chicago, IL: University of Chicago Press. Nordmann, A. 2004. Nanotechnology’s worldview: New space for old cosmologies. IEEE Technology and Society Magazine 23: 48–54. Preston, C.J. 2004. The promise and threat of nanotechnology: Can environmental ethics guide us? Hyle: International Journal of Philosophy of Chemistry 10: 19–44. Rip, A et al., eds. 1995. Managing Technology in Society: The Approach of Constructive Technology Assessment. London: Pinter. Roco, M.C. and W.S. Bainbridge, eds. 2002. Converging Technologies for Improving Human Performance: Nanotechnology, Biotechnology, Information Technology and Cognitive Science. Arlington, VA: National Science Foundation. Salamanca-Buentello, F et al. 2005. Nanotechnology and the developing world. PLoS Medicine 2.5: 100–103. Schummer, J. 2003. The notion of nature in chemistry. Studies in History and Philosophy of Science 34: 705–736. Schummer, J. 2004a. Interdisciplinary issues of nanoscale research. In Discovering the Nanoscale, eds. D. Baird, A. Nordmann and J. Schummer, 9–20. Amsterdam, NH: IOS Press. Schummer, J. 2004b. Multidisciplinarity, interdisciplinarity, and patterns of research collaboration in nanoscience and nanotechnology. Scientometrics 59: 425–465. Schummer, J. 2004c. Societal and ethical implications of nanotechnology: Meanings, interest groups, and social dynamics. Techné: Research in Philosophy and Technology 8.2: 56–87. Schummer, J. 2005. Reading nano: The public interest in nanotechnology as reflected in book purchase patterns. Public Understanding of Science 14: 163–183. Schummer, J. 2006a. Historical roots of the ‘mad scientist’: Chemists in 19th-century literature. Ambix 53: 99–127. Schummer, J. 2006b. Nano-Erlösung oder Nano-Armageddon?—Technikethik im christlichen Fundamentalismus. In Nanotechnologien im Kontext: Philosophische, ethische und gesellschaftliche Perspektiven, eds. A. Nordmann, J. Schummer and A. Schwarz, 263–276. Berlin, Germany: Akademische Verlagsgesellschaft. Schummer, J. 2007a. Identifying ethical issues of nanotechnologies. In Nanotechnology: Science, Ethics and Policy Issues, ed. H. ten Have. Paris: UNESCO. Schummer, J. 2007b. The Global Institutionalization of Nanotechnology Research: A bibliometric Approach to the Assessment of Science Policy. Scientometrics 70.3: 291–307. Schummer, J. 2008. The Impact of Nanotechnologies on Developing Countries. In Nanoethics: Examining the Societal Impact of Nanotechnology, eds. F. Allhoff, P. Lin, J. Moor, and J. Weckert. Hoboken, NJ: Wiley Press. US National Nanotechnology Initiative to the 21st Century Nanotechnology Research and Development Act (Sec. 2). White House, Office of the Press Secretary. 2000. National nanotechnology initiative: Leading to the next industrial revolution. Press release, 21 January 2000, Washington, DC. Wilsdon, J. and R. Willis. 2004. See-Through Science: Why Public Engagement Needs to Move Upstream. London: Demos.

Chapter 15

Transnational Nanotechnology Governance: A Comparison of the US and China1 Evan S. Michelson and David Rejeski

15.1

Introduction

Nanotechnology is expected to become a key, transformative technology of the twenty-first century. Researchers are exploring ways to see and to build at this small scale by re-engineering familiar substances like carbon, silver, and gold to create new materials with novel properties and functions. Nanotechnology applications in areas as diverse as healthcare, energy storage, agriculture, water purification, and security are envisioned, and some experts predict nanotechnology will be as important as the steam engine, the transistor, and the Internet in terms of societal impact (Project on Emerging Nanotechnologies 2006). Not surprisingly, these anticipated developments have encouraged significant investments in nanotechnology research and development (R&D) worldwide, with the United States’ National Science Foundation (NSF) estimating that by 2015 nanotechnology will have a $1 trillion impact on the global economy (Roco et al. 2000). Inevitably, the high stakes associated with the political, economic, and societal development of nanotechnology have led it to become an intense field of international competition and cooperation. A survey compiled by the International Risk Governance Council (IRGC) lists nearly 30 countries in the developed and developing world that are conducting nanotechnology R&D (Survey on Nanotechnology Governance: Volume A 2005) and corporations headquartered throughout North America, Europe, and Asia have already begun to commercialize nanotechnology

1 An earlier version of this paper was presented by Evan Michelson at the Young Researchers Symposium at the National Research Center for Science and Technology for Development, Beijing, China, 19 October 2006, in conjunction with the US-China Forum on Science and Technology Policy, Beijing, China, October 16–17, 2006. Research was supported by the George Mason University Science and Trade Policy Program, under a grant from the National Science Foundation, and The Pew Charitable Trusts. The opinions expressed in this article are those of the authors and do not necessarily reflect views of George Mason University, the National Science Foundation, the Woodrow Wilson International Center for Scholars, or The Pew Charitable Trusts.

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products. Lux Research, in The Nanotech Report: 4th Edition, estimates that “governments worldwide spent $4.6 billion on nanotechnology in 2005” and that “established corporations spent $4.5 billion nanotechnology R&D worldwide” in the same timeframe (Lux Research 2006a). In particular, nanotechnology has emerged as a central science and technology policy topic in both the US and China, and, accordingly, it is expected to pose a number of significant transnational governance challenges and opportunities for a wide range of stakeholders—including government, industry, and the public—in the near future. These broad ranging issues will have to be addressed in a collaborative and proactive manner in order to make certain that nanotechnology is developed in a safe, sustainable, and responsible manner. By analyzing a number of these transnational governance matters, this essay will sketch out some of the multiple and complex factors and needs involved in establishing appropriate management strategies for nanotechnology in particular and for new and emerging technologies in general. In particular, five points will be addressed, including: ● ● ● ● ● ●

Prioritization of nanotechnology research and development; Need for internationally coordinated risk research strategies; Need for effective oversight mechanisms; Rapid commercialization of consumer products; Potential for transnational cooperation and collaboration; and Low levels of public awareness and trust in government.

Overall, this assessment will illuminate that a host of new occasions for collaboration and topics for deliberation will emerge as developments in nanotechnology move from the fringes to the center of society. Policymakers in both the US and China must begin to focus on questions as diverse as how does nanotechnology factor into their nation’s long-term future, who does the public trust to handle and manage the potential risks posed by nanotechnology, how should information related to nanotechnology be communicated and made available to the public, what mechanisms work best to regulate nanotechnology-based products, and how can potential chronic risks and consequences be systematically analyzed and addressed by government agencies. Clearly, in order to adequately tackle these interrelated subjects, an open dialogue is needed that can produce imaginative approaches to the governance of nanotechnology.

15.2

Prioritization of Nanotechnology Research and Development

As noted earlier, both the US and China have been at the forefront of this trend in adopting nanotechnology as a main component of their strategic policy plans for future developments in science and technology. This was most recently enunciated in the February 2006 report from the US Office of Science and Technology Policy, American Competitiveness Initiative: Leading the World in Innovation, which

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articulates that in order to succeed on the global stage, the US must develop a necessary suite of technology platforms that includes “world-class capability and capacity in nanofabrication and nanomanufacturing that will help transform current laboratory science into a broad range of new industrial applications for virtually every sector of commerce” (Domestic Policy Council 2006) China has taken a similar approach in its recently released National Medium- and Long-term Science and Technology Development Plan (2006–2020), where nanotechnology is identified as a “priority mission area” (Suttmeier et al. 2006) and as a key frontier technology over the next 15 years. As Cao, Suttmeier, and Simon note, nanotechnology is one of four “megaprojects” explicitly mentioned in the plan (Cao et al. 2006). For China, the overall aim is to use nanotechnology R&D as way toward reaching its eventual goal of setting “the proportion of research and development expenditures at 2.5% of the gross domestic product” (Feng 2006). A report from the Asian Technology Information Program (ATIP), Nanotechnology Infrastructure in China, indicates that China is well on its way to bolstering its nanotechnology R&D capacities, as it is anticipated that “the construction of nanotechnology centers in Beijing and Shanghai will be completed in 2007” and that “a third center in Tianjin with be completed in 2008, as well as another center in Suzhou” (Nanotechnology Infrastructure in China 2006). More specifically, nanotechnology research priorities in both countries seem to be progressing along similar lines of inquiry, with two of their similar aims being both the societal benefit of nanotechnology and a better understanding the intersections and inter-relationships between nanotechnology and other strands of technology. With respect to these points, the Guide to Programs from the National Natural Science Foundation of China (NSFC) highlights “basic research on nanoscience and technology” as one of two new Major Research Plans for 2006, the broader aim of which is to “solve nanoscience issues that are of great importance in the progress of science and technology of China” and use nanotechnology commercialization toward “the development of the national economy” (Guide to Programs: Fiscal Year 2006 2006). NSFC also highlights a range of interdisciplinary scientific goals, from studying “nanomaterials design and preparation” to “new theory and new methods for nanosystem construction,” with particular and preferential emphasis on funding areas in “nanoelectronics and nanoelectronics devices” and “nanobiology” (Guide to Programs: Fiscal Year 2006 2006, 127–128). In the US, The National Nanotechnology Initiative Strategic Plan offers a vision in which nanotechnology becomes socially relevant by facilitating the “transfer of new technologies into products for economic growth, jobs, and other public benefit” and simultaneously developing “educational resources, a skilled workforce, and the supporting infrastructure and tools to advance nanotechnology” (Office of Science and Technology Policy 2004) Moreover, the National Nanotechnology Initiative’s (NNI) Supplement to the President’s FY 2006 Budget makes a point to emphasize “interdisciplinary research at the intersections of nanotechnology, biotechnology, and information technology,” noting that a variety of federal agencies “will seek new opportunities for synergistic research” at the interfaces of these technologies (Office of Science and Technology Policy 2005).

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Both countries are also ensuring that substantial funding and financial investments are directed toward nanotechnology (Schulte 2005). In the US, the 2007 budget request allocates over $1.2 billion under the NNI, bringing total federal government spending in nanotechnology to over $6.5 billion since the NNI’s inception in 2001 (National Nanotechnology Initiative 2006). While it is difficult to accurately compare funding levels between the US and China, Lux Research estimates that the Chinese government spent $250 million on nanotechnology in 2005—a figure that, when adjusted for purchasing-power parity, places China’s nanotechnology investment second only to the US (Lux Research 2005). Similarly, local, state, and regional governments in the US and China are investing in nanotechnology, with US hotspots including California (Blue Ribbon Task Force 2005), Texas, Virginia, Massachusetts, and New York, and with Chinese hotspots including Beijing, Hong Kong, and Shanghai, the latter of which established the Shanghai Nanotechnology Promotion Center in 2001 (Blanpied 2006). Such investments by both the US and China have begun to translate into worldclass research results in terms of published papers, paper citations, and patents. In particular, while US leadership in the field has been consistent throughout previous decades, China’s transformation into an emerging nanotechnology power is more recent. In their article on the subject, Liu and Zhang (2005) highlight various supporting points for this claim, noting that a 2001 Asia-Pacific Economic Cooperation (APEC) report indicated that China followed only the US and Japan in terms of the number of nanotechnology papers published in that year. They also note that studies undertaken by the Scientific Citation Index indicate that during the 1992–2002 timeframe, the top four institutions with the most citations of published nanotechnology papers include the University of California-Berkeley, IBM, MIT (all in the US), and the Chinese Academy of Sciences. Finally, they cite an estimate that from 2000 to 2002, China ranked third behind only the US and Japan in terms of the number of nanotechnology patents held. More recent studies analyzing publication outputs from 1999 to 2004 have shown similar results, with China maintaining its third place position with roughly 7,000 papers (Hullmann 2006). Taken together, these data points indicate, as Andrew Batson of The Wall Street Journal notes, that “China is rapidly catching up to the U.S. in nanotechnology” and that this “success could hold lessons for U.S. policy makers seeking to maintain a competitive edge in scientific research” (Batson 2006).

15.3

Need for Internationally Coordinated Risk Research Strategies

However, even given the currently high level of funding and planning for nanotechnology, there are no currently internationally coordinated risk research strategies designed to investigate and manage the potential environmental, health, and safety (EH&S) risks posed by nanotechnology. In the absence of such risk management strategies, it will be difficult for the science community to determine the potential

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downsides of the technology and reach conclusions about where the greatest risks may lie. Over the past 15 years, scientific data on the EH&S impacts of nanostructured materials have been growing slowly. However, research results on the implications of engineered nanomaterials have been readily available only for the past 5 years (Oberdörster et al. 2005; Maynard and Kuempel 2005). Though much more work needs to be done in this area, a number of research studies have begun to raise more questions than answers about potential hazards—hazards that could impact populations in developed countries, like the US, and in more developing countries, like China. In short, published research has demonstrated that because of their unique size, shape, and chemistry, some engineered nanomaterials can behave differently in the body and in the environment than more conventional materials. Moreover, these nanomaterials may present health risks that are not captured within established risk assessment paradigms. For example, in testimony before the US Senate Committee on Commerce, Science, and Transportation, J. Clarence Davies, Senior Advisor to the Project on Emerging Nanotechnologies, highlighted concerns raised by some of these early-stage risk research results, including: ●

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Nanometer-scale particles behave differently from larger sized particles in the lungs, possibly moving to other organs in the body; The surface of some nanostructured particles is associated with toxicity, rather than the more usually measured mass concentration; and Conventional toxicity tests do not seem to work well with some nanomaterials, such as carbon nanotubes (Davies 2006).

In order to learn more about the novel effects of nanomaterials on human health and the environment, it is clear that more research will be needed. To this end, both the US and Chinese governments have begun to heed the call for more risk-related research. Though the US government estimates that it spent $38.5 million on EH&S research in 2005, there are analyses that place this figure closer to $11 million, indicating that increased resources are needed if these risk-related issues are to be addressed (Maynard 2006). However, recent signs indicate that the US government is looking to increase its commitment to this issue in the future, as it released a long-awaited document on EH&S research needs, Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, in September of 2006 (The National Nanotechnology Initiative 2006) and held the first public meeting on EH&S research prioritization in January 2007 (National Nanotechnology Coordination Office 2007). More specifically, the Environmental Protection Agency (EPA) plans to nearly double its implications research budget in fiscal year 2007 and has put together a Nanotechnology White Paper that identifies a set of key questions that the agency should address as nanotechnology R&D progresses (US Environmental Protection Agency 2005). Though China has trailed the US in terms of focusing its resources on investigating EH&S issues, it is beginning to address these concerns more directly. Clayton Teague, director of the US National Nanotechnology Coordination Office, has publicly raised efforts by the Chinese government to make research into the EH&S

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implications of nanotechnology a priority (Phibbs-Rizzuto 2007). Additionally, China has taken action by beginning to study the potential toxicological effects of nanotechnology by establishing a Nanosafety Lab under the auspices of the National Center for Nanoscience & Technology (NCNST), located in Beijing. It is estimated that the Chinese government will spend nearly $3.2 million on such EH&S research from 2006 to 2010 through its new program “Health and Safety Impacts of Nanotechnology: Exploring Solutions”—an amount of money that, once again, may rather substantial in terms of purchasing-parity power (Chen 2006). Moreover, as demonstrated by hosting the International Symposium on Nanotechnology in Environmental Protection and Pollution in Hong Kong in June 2006 (Asia Pacific Nanotechnology Forum 2006) and the 3rd International Symposium on Nanotechnology, Occupation and Environmental Health in Taiwan in late 2007 (Academia Sinica), it is becoming evident that China is looking to play an increasingly substantial role in advancing nanotechnology EH&S research in the future. Nevertheless, focusing solely on such investments does not address the issue of whether government agencies in the US or China possess sufficient human and strategic resource capacities to adequately address EH&S concerns raised by academic researchers and various non-governmental organizations (NGOs). For instance, the Project on Emerging Nanotechnologies has assembled the only publicly available inventory of ongoing EH&S research projects, indicating that there may be significant gaps—such as a lack of research on the effects of nanomaterials in the gastrointestinal track and few resources devoted to life-cycle analysis and end-of-life issues—that have yet to be systematically addressed in the present risk research portfolio. Moreover, Andrew Maynard, in his report Nanotechnology: A Research Strategy for Addressing Risk, has argued that a new, internationally coordinated, comprehensive framework for methodically exploring nanotechnology’s possible risks is needed both to address such research gaps and to ensure that the limited financial resources devoted to these issues are leveraged in a strategically planned portfolio of short, medium, and long-term projects (Maynard 2006).

15.4

Need for Effective Oversight Mechanisms

In the US, there is currently a concern amongst a wide range of NGOs—including Environmental Defense, Natural Resources Defense Council, Friends of the Earth, International Center for Technology Assessment, and ETC Group—that, so far, the US government’s overall regulatory approach to nanotechnology been ad hoc and incremental, with little attention focused on how nanomaterials are already being used in consumer and industrial products. As will be discussed in greater depth in following sections, one difficulty is that there are many kinds of nanotechnology-based consumer products, such as cosmetics and dietary supplements, that are entering the market in areas where there is less government oversight. This point is emphasized in a recent Project on Emerging

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Nanotechnologies submission to the Food and Drug Administration (FDA), where it is argued that the government’s approach to nanotechnology oversight has been limited by a number of factors, including: ●

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Insufficient consideration of how nanotechnology systematically impacts a range of agencies, including EPA, FDA, the US Department of Agriculture (USDA), and the Consumer Product Safety Commission (CPSC); A focus on single statutes, such as EPA’s Toxic Substances Control Act (TSCA), rather than on an integrated, multi-statute approach; and A focus on regulating products more than on the facilities where production occurs and processes are used.2

Concerns about regulatory jurisdiction and responsibility are particularly pressing because as new nanotechnology based products are commercialized, it is evident that similar kinds of nanomaterials will be employed in a variety of ways, requiring substantial coordination of oversight on the part of government agencies tasked with ensuring the health and safety of the public and the environment. Similar problems related to regulatory overlap and confusion could occur in China as well, especially if the government is focused primarily on funding and supporting R&D related to nanotechnology’s applications and places less importance on managing the possible implications of nanotechnology. Only a concerted effort between different parts of the regulatory system—at local, state, national, and international levels—within both countries will be able to overcome these governance challenges and ensure that consistent regulatory regimes and safety standards are developed worldwide. One possible solution, as Davies argues in his report Managing the Effects of Nanotechnology, is that a new law or set of laws may be required to address the current oversight system’s deficiencies (Davies 2006). However, the difficulties associated with managing nanotechnology’s potential risks are not restricted to a simple lack of regulation. For instance, many countries may be forced to rely on potentially outdated legislative and regulatory regimes that are not equipped to address nanotechnology’s potentially revolutionary impacts. Additionally, in more developing countries like China, government agencies may still be grappling with the policy implications of past and on-going technological revolutions, particularly those associated in biotechnology, genomics, and information technology. In short, because the bureaucracies of these nations may already be stretched thin to deal with a range of science and technology challenges, they could be hard-pressed to oversee the responsible development of nanotechnologies in a proactive manner. Recently, there have been attempts to address this lack of effective oversight mechanisms through advancing nationally and internationally coordinated efforts in this area. On a national level, a voluntary information reporting program for

2 “FDA-Regulated Products Containing Nanotechnology Materials [Docket No. 2006N-0107],” Comments submitted to the FDA Nanotechnology Public Meeting, Washington, DC: Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, 19 July 2006.

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engineered nanomaterials has been developed by the Department for Environment, Food, and Rural Affairs (Defra) in the UK (UK Voluntary Reporting Scheme for Engineered Nanoscale Materials 2006) and a voluntary stewardship program is being planned by the EPA in the US for the middle of 2007 (Rizzuto 2006). Additionally, in China, Chunli Bai, Executive Vice President of the Chinese Academy of Sciences, notes that China has established a “national technical committee on nanotechnology standardization,” charged with “strengthening the inspection of research facilities in public institutions and with meeting the needs of manufacturers in China” (Bai 2005, 63). On an international level, the Organization for Economic Co-operation and Development (OECD) recently established a Working Party on Manufactured Nanomaterials to discuss issues surrounding the environmental, health, and safety implications of nanotechnology, particularly in the area of chemicals and toxic substances (Organization for Economic Co-operation and Development 2006). More specifically, both the Meridian Institute’s Global Dialogue on Nanotechnology and the Poor (GDNP) (Meridian Institute 2005) and the United Nations Industrial Development Organization (UNIDO) North-South Dialogue are explicit attempts to include developing countries in the global discussion of managing nanotechnology’s risks and benefits (Shand and Wetter). The IRGC is also in the process of developing an oversight and risk management framework for nanotechnology through an elaborate consultation process that includes input from a range of stakeholders in multiple countries (International Risk Governance Council 2006). Finally, attempts to collect and detail “best practices” for worker protection and standardize nanotechnology nomenclature and definitions are occurring on an international basis, with efforts underway through the International Council on Nanotechnology (ICON) (2006), the International Standards Organization (ISO) (International Organization for Standards 2005) and ASTM International (2006). While representatives from the US and China are actively participating in a number of these oversight endeavors, it is of great importance that the national governments of these countries remain committed to structuring their own, internal regulatory system in harmony with such international efforts. Doing so will allow for the establishment of a globally level playing field for private firms involved in commercializing nanotechnology research and products and, in turn, ensure that they do not encourage irresponsible corporate actors, thereby damaging the industry as a whole.

15.5

Rapid Commercialization of Consumer Products

Concerns about the shortage of toxicity data and lack of effective oversight mechanisms are all the more pressing given the rapid commercialization of nanotechnology in consumer and industrial products. In March 2006, the Project on Emerging Nanotechnologies released an online inventory that now contains over 300 manufacturer-identified, nanotechnology-based consumer products that

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are available on the market from over 15 countries, including the US, China, and many European and Asian nations (Project on Emerging Nanotechnologies). This number far exceeds the previous US government accepted estimate of approximately 80 consumer products on the market, and, according to EmTech Research, there are an additional 600 nano-based electronics components, raw materials, drug delivery technologies, and research, process, and software tools, the latter of which is used to manipulate nanomaterials and fabricate at the nanoscale (US Environmental Protection Agency 2005.). However, since the searches conducted by the Project on Emerging Nanotechnologies were largely limited to Englishlanguage sources, it is expected that there may be many more nanotechnology consumer products on the market throughout Asia—particularly in China—that have yet to be accounted for, thereby further increasing the current extent of nanotechnology’s commercialization. As of November 2006, this inventory of nanotechnology consumer products has grown by nearly 70% and now includes over 380 products. Nanoscale silver is now the most often identified nanomaterials used in consumer products in the inventory. The number of products containing nano-engineered silver—which is used for its anti-microbial properties—has nearly doubled in that March–November period. The second highest nanoscale material cited by manufacturers is carbon—including carbon nanotubes and fullerenes—which is up almost 35%. Inevitably, the rapid commercialization of nanotechnology consumer products has begun to impact the policy-making process, especially in the case of nano-engineered silver. In early 2006, the EPA was petitioned by two wastewater utility organizations—the National Consortium of Clean Water Agencies (NACWA) (Kirk 2006) and Tri-TAC (Weir 2006)—to require the registration of some nanosilver products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In November 2006, the agency reversed an initial decision against requiring such registration and decided that such categorization was, in fact, necessary in the case of one product, a washing machine made by Samsung (Weiss 2006). It has yet to be determined whether this ruling will extend to all nanosilver products. The fact that this first wave of consumer products is already available on store shelves may be surprising, especially since only a few years ago, there were a mere handful of nanotechnology companies and virtually no nanotechnology-based products being made and marketed to consumers. However, it has been estimated that over the past few years, 1,200 nanotechnology-related start-up companies have emerged, many of which are based in the US (Lane and Kalil 2005). In China, Liu and Zhang (2005, 399) have estimated that “the number of registered companies with a nanotechnology focus reached 800 by [the] end of 2003, resulting in a total of 10 billion RMB ($1.2 billion) in registered capital.” Along these lines, Lux Research has estimated that more than $32 billion in products incorporating nanotechnology were sold worldwide in 2005, a number that is only expected to grow as more research is funded, more patent applications are filed, and more companies are formed (Lux Research 2006b). Moreover, as Appelbaum, Gereffi, Parker, and Ong (2006) note in their paper “From Cheap Labor to High-Tech Leadership: Will China’s Investment in Nanotechnology Pay Off?”, China’s early entrance in the

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global nanotechnology value chain and its initial investments in nanotechnology R&D will give it a chance “to build up…early links in the value chain in an area where developed nations have far less of a head start.” A search of the Nanotechnology Consumer Products Inventory can provide numerous examples of products already on the market, ranging from cosmetics and personal care items to dietary supplements and cooking supplies and from automotive and home improvement products to advanced coatings for glass surfaces and stain-resistant clothing. In many cases, these products are available for purchase in local stores or over the Internet. However, in the event of a mishap or accident, it is not clear whether product safety laws in the US, China, or elsewhere are sufficiently robust to protect the public’s health or safety. While such a situation may sound far-fetched, there has already been the case of Magic Nano, a bath and tile treatment product sold in Germany that was recalled after causing significant health problems, with over 100 people affected with respiratory problems and six hospitalized with pulmonary edema (Graber and Phibbs 2006). Although the Federal Institute for Risk Assessment (BfR) in Berlin concluded that the product did not actually contain nanomaterials and that nanotechnology was not the cause of the reported health problems (Federal Institute for Risk Assessment 2006), the Magic Nano incident illuminated other concerns—such as a lack of transparency in terms of timely disclosure of information and misuse of a third-party verification seal purporting to ensure that the product was independently tested—that could affect regulatory agencies in the US or China if a similar situation were to occur in either country. It is also anticipated that there are many more nanotechnology consumer products on the market that are either not labeled or described as containing nanomaterials or that make claims about nanotechnology that may not be accurate. While there are currently no stipulated requirements to either label a product that contains nanomaterials or independently verify claims associated with nanotechnology, such products are beginning to garner increased attention and scrutiny from consumer and environmental groups around the world, including: ●

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In the US and Australia, environmental groups have called for an interim recall of sunscreens that contain nanosize zinc oxide and titanium dioxide until more adequate safety tests are undertaken (International Center for Technology Assessment 2006); In Korea, a consumer group has tested a washing machine claiming to use silver nanomaterials as anti-bacterial agents and has concluded that there was little to no improvement in performance over similar products that did not contain nanotechnology (Testing and Research Institute 2005); and In Germany, a media outlet has investigated claims made by a dietary supplement manufacturer that purports to use nanotechnology to make vitamins more easily available to the body (Berger 2006).

Such instances illustrates a growing policy challenge: the mislabeling or overpromising associated with nanotechnology consumer products may have the potential to negatively impact the public’s perception of the field in general, well before

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potentially more significant and transformative applications, in applications such as healthcare and energy, can be developed. Bai indicates that this tension between nanotechnology hype and reality is beginning to emerge in China. He notes that while there are rising numbers of legitimate and beneficial applications of nanotechnology being made available through commercialization—such as the use of photocatalytic nanoparticles in a self-cleaning glass coating on the new National Opera House in Beijing—some firms are taking advantage of nanotechnology’s growing popularity as a buzzword and are “finding that they can raise their profits simply by adding the label ‘nano’ to their products” (Bai 2005, 63). It is imperative that such misunderstandings are avoided in the US and China so that a consumer backlash does not occur and that the nascent nanotechnology industry has an opportunity to develop more fully over the long term.

15.6 Low Levels of Public Awareness and Trust in Government Given the increasing availability of nanotechnology consumer products worldwide, it might be expected that the public would be rather familiar with the term “nanotechnology” and understand what it means. However, in the midst of this accelerating commercialization, publics throughout the world remain largely in the dark about nanotechnology. A major study, funded by the NSF and conducted in 2004 by Michael Cobb and Jane Macoubrie at North Carolina State University (NCSU), found that 80%–85% of the American public has heard “little” or “nothing” about nanotechnology (Cobb and Macoubrie 2004). Similarly, a nationally representative, August 2006 poll of over 1,000 adults, commissioned by the Project on Emerging Nanotechnologies and conducted by Peter D. Hart Research Associates, found similar results, with about 70% of the public reporting that they have heard little to nothing at all about nanotechnology (Peter and Hart Research Associates 2006). These findings are consistent with similar polls that have been commissioned in Europe and Canada, and it is possible that these trends associated with low levels of public of understanding of nanotechnology would also occur in China as well (BMRB Social Research 2004; Einsiedel 2005). Bai (2005, 61)alludes to this potential lack of awareness about nanotechnology by the Chinese public by noting that, “the scientific community need[s] to better inform and educate the public about the transformations this new era is likely to bring.” Without such public engagement efforts, citizens and consumers may form negative public perceptions that could hinder nanotechnology’s development far into the future. What is even more striking about the public perception studies mentioned above is that, in addition to a lack of basic awareness about nanotechnology, publics in many countries have little to no trust in their government’s ability to manage the potential risks posed by nanotechnology. Such findings were illustrated in Jane Macoubrie 2005 study, Informed Public Perceptions of Nanotechnology and Trust in Government, which found that even when participants were provided with information about the roles and responsibilities of government regulatory agencies, such

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as EPA, FDA, USDA, and CPSC, no more than 50% of respondents believed that they could trust these agencies to regulate nanotechnology-based products accurately and successfully (Macoubrie 2005). Along these lines, the Hart Research data also indicates that while public approval ratings for various agencies has declined in recent years, there tends to be more confidence in these bodies than in business or industry to management technological risk. It is evident that if concerns about government’s and industry’s ability to manage nanotechnology’s risks are not addressed, these negative public perceptions may continue to grow and, once again, potentially hamper nanotechnology’s development due to consumer backlash or over-regulation. To address this current situation—in which a largely uninformed or underinformed public has little to no trust in the government’s ability to manage nanotechnology’s risks—Macoubrie (2005, 15) has found that respondents have centered on a desire for “increased safety tests before products go to market” and “supplying more information to support informed consumer choices.” Additionally, by focusing on the issue of monitoring the safety and effectiveness of cosmetics and over-thecounter drugs—two product categories that have seen relatively high amounts of nanotechnology commercialization in recent years—Hart Research found that the public feels that federal government agencies, along with universities and independent researchers, should work together and be involved in such oversight. Such proactive and integrated policy steps would not only help build awareness, trust, and citizen engagement around nanotechnology, but they would signal to citizens and consumers that their concerns are being heard and addressed. As of now, there is still time to inform public perceptions about nanotechnology and to make clear that nanotechnology is being developed in a way that citizens—as well as the insurance industry, corporate investors, NGOs, and regulatory officials—can trust. However, with the production of nanomaterials ramping up in the US and China, and with more and more nanotechnology-based products pouring into the marketplace, this window is closing fast. Without such assurances, publics around the world will increasingly have to make sense of competing claims, complex science, and emerging risk research with little or no preparation or support. Conversely, worries are already being voiced that public input will be used simply as a “tokenistic add-on” rather than as a valuable policy-making tool (Saleh 2006). To avoid this undesired outcome in both the US and China, coordinated nanotechnology education and engagement programs will be needed, supported by both government and industry. These efforts will have to be structured to reach a wide range of consumers, many of which may have little to no scientific or technical training. Establishing such a widespread public engagement campaign will require the use of both traditional media outlets—such as print, radio, television, and film—alongside more non-traditional media outlets—such as the Internet, weblogs, games, and podcasts—to capture the attention of a diverse range of individuals in various age, gender, and socioeconomic categories. As researchers (Grove-White et al. 2004) from the UK argue, a new approach to public engagement is required, one that can “build in more rich, more complex and nuanced, and more mature models of publics into ‘upstream’ modes of practice.”

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15.7 Potential for Transnational Cooperation and Collaboration It should be evident that nanotechnology presents a series of unique opportunities for the US and China to collaborate and cooperate early-on in a technology’s development. Such endeavors could be pursued at the micro-level (by individual researchers), meso-level (by universities or corporations), or macro-level (by governments and through international organizations). Though some degree of cooperation is already underway through the standard-setting process and through burgeoning risk-research prioritization efforts, there may be additional points of focus that could be cause for significant and sustained interaction between the US and China with respect to nanotechnology. Five such areas of interest—promoting Green Nanotechnology, assisting small- and medium-sized enterprises, sponsoring foresight activities, examining state and local initiatives, and focusing on the developing world—are discussed below. First, the US and China can jointly emphasize the development of “green,” or environmentally benign, approaches to nanotechnology R&D. Rather than going down the traditional path of addressing risks after-the-fact, these two countries have the potential to work together to fund efforts with the aim of designing and engineering risks out of both nanotechnology-based products and production processes. This policy option requires developing approaches that reduce harmful emissions, cut energy and material inputs, and provide potential environmental benefits. In order to advance this concept, the Project on Emerging Nanotechnologies has spearheaded a series of pubic seminars and a scientific symposium on the topic of Green Nanotechnology (Project on Emerging Nanotechnologies). However, so far, only a small amount of funding at EPA in the US has been directed towards investigating and concretizing this notion, but this area has not received the attention it deserves in the wider international arena, let alone in China. The US and China should work together to lead the development of a strategy for Green Nanotechnology and explore policy options that could provide incentives for industry to address risks early, rather than study them later. In doing so, the overall goal would be to stress the importance of developing clean technologies to minimize potential environmental and human health risks associated with the manufacture and use of nanotechnology products and to encourage replacement of existing products with new nanotechnology products that are more environmentally friendly throughout their life cycle. Second, the two countries can work together to ensure that small- and medium-sized businesses, start-ups, and laboratories have access to up-to-date EH&S, intellectual property (IP), and export/import information. As research and commercialization becomes global—with labor and capital flowing ever-more freely across international boundaries—the US and China will become nodes in a closely connected innovation system that will link small- and medium-sized businesses more directly than with previous technological advancements. Through the development of a clearinghouse of nanotechnology information aimed directly at reaching out to smaller institutions, both countries would be supporting compatible “push strategies” that help drive necessary information toward those stakeholders in greatest need.

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One of the best ways of delivering this information is the development of publicprivate partnerships, using “intermediaries”—such as professional societies and university technical assistance programs—that already tend to be global in scope. China and the US could similarly provide incentives to larger, multi-national companies that are willing to push their EH&S, IP, and export/import know-how down their supply chains to smaller firms involved in nanotechnology production. Third, because of their size and centrality to the global nanotechnology R&D process, the US and China can collaborate on sponsoring and maintaining foresight activities that regularly attempt to gauge and identify long-term trends in nanotechnology research, governance, and commercialization. Because of the critical mass of researchers and policymakers engaged in the nanotechnology endeavor in both nations, there is the real possibility of holding fruitful scenario development workshops, forward-looking discussions on specific topics of concern (for example, military uses and privacy), and engaging in roadmapping and other trend-spotting exercises. These efforts would not only have the effect of encouraging scientists, industry leaders, and government representatives to think long-term, but they could be easily expanded to include members of the NGO community, media, and general public. Eventually, the products of these foresight activities could form the basis of an expanded public outreach and education campaign in both countries, thereby ensuring that increasing segments of society learn about nanotechnology’s risks and benefits. Fourth, as discussed earlier, there is an emphasis in both the US and China on local and state level innovation and oversight. Though this trend is more prevalent in the US—where, in December 2006, the City of Berkeley became the first municipality to regulate nanotechnology (DelVecchio 2006)—than in China, both countries could benefit from a better understanding of how these sub-national activities can be initiated, managed, and evaluated. A jointly sponsored meeting by the US and China on this topic could examine what lessons can be learned for nanotechnology-focused cities on both sides of the Pacific and whether there is the potential for individual municipalities to collaborate alongside nation-to-nation cooperation programs. It could investigate what would be the effect of a patchwork of local regulatory schemes on innovation and commercialization in lieu of more systematically applied federal or international oversight mechanisms. Finally, such knowledge sharing could highlight the role of transparency in science policy development and the need for openness, dialogue, and communication when a new technology is entering the market. Fifth, there is an increasing need to ensure that the benefits of nanotechnology are explicitly aimed at addressing the problems of the developing world. As China increases its aid assistance to Africa (Traub 2006) and the US seeks to maintain its influence in Southeast Asia, both countries have an inherent interest—perhaps even a responsibility—to ensure that appropriate funding and support is given to research projects designed to improve water sanitation, reduce disease, and distribute cheap, clean energy. A set-aside program from the budget of each country’s respective nanotechnology initiative into a common pool of money directed at applying nanotechnology in the developing world would go a long way toward bolstering

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these efforts. In this area, experts have already identified a well-defined set of research priorities and resources are now needed to ensure that these questions are adequately tackled. Without such concerted resource allocations for creating nanotechnology applications specifically geared toward improving human development, there is a real risk that a “nano-divide” will come to increase the existing schism between the developed and developing world.

15.8

Conclusion: The Tip of the Nanotechnology Iceberg

It would be unfortunate if government agencies, in the US, China, and elsewhere, squandered this unique opportunity to help direct nanotechnology along a responsible path, improve public confidence in the private and public sectors, and increase the capacity of public institutions to deal with the risks and challenges posed by cutting-edge innovation. The thrust of the arguments presented above is clear: nanotechnology is here and that we, as a global society, are not yet fully prepared to deal with it. The encouraging point is that a collective response—with the US and China as central players—to the aforementioned challenges can still be formulated. Much remains to be done, however, and it cannot be assumed that addressing such transnational nanotechnology governance questions will be easy. In fact, the opposite is true, since nanotechnology’s development is expected to test the notion that innovation progresses in a linear and continuous fashion. Due to the rapid pace of R&D, discoveries in nanotechnology could come in great, discontinuous leaps and, in turn, revolutionize society’s knowledge and understanding of the physical world in rather short amounts of time. In turn, these technological leaps could come to strain the ability of public institutions and public infrastructure—especially in China, which will likely face an additional host of resource, population, and energy challenges in the coming decades—to respond in an effective and timely manner. For this reason, authors such as Michael R. Taylor (2006), in his report Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?, argue that the eventual success or failure at overseeing nanotechnology will be based on the devotion of various kinds of resources—human, strategic, regulatory, and financial—to the issue. While Taylor makes this argument in the context of one agency (the FDA) in one country (the US), the point and ensuing recommendations are applicable both for other agencies and for other countries. Such resources will become even more crucial and important as broader, cross-cutting policy issues— such as trade, intellectual property protection, and the open sharing of scientific and technical information—begin to emerge with respect to nanotechnology. While specific analyses of nanotechnology’s interface with these larger areas of concern is beginning to occur (Hermann et al. 2005), it is clear that the expected innovative jumps increasingly associated with nanotechnology’s future could make today’s issues related to product risk management and internationally coordinated oversight strategies appear trivial by comparison. Such would be the case in the wake

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of a high-profile mishap or perceived accident, as occurred with respect to other areas of technological development, such as chemicals (e.g., Bhopal) and nuclear power (e.g., Three Mile Island). In the meantime, in order to make certain that nanotechnology does not “fall through the cracks” of the oversight system, a dual risk management approach must be adopted, one that supports research into nanotechnology’s greatest near-term risks and benefits while, simultaneously, looks prospectively to any transformations or shifts in the technology’s development that that may occur in the future. Though nanotechnology R&D is currently an effort based largely upon chemistry and materials science, many anticipate that the applications and innovations developed to date are only the tip of the iceberg. Instead, the high priority placed on it in both the US and China will quickly lead nanotechnology to interact with other fields of study—such as biotechnology, information technology, and cognitive science—that could further quicken the pace of both basic research and product development. This convergence of technologies could cause an even greater set of governance challenges than nanotechnology alone, further impacting institutions tasked with the responsibility of managing new technological advances. Since developments in nanotechnology are at the forefront of these potentially radical innovations, the US and China have the chance to think and operate proactively, and work collectively, toward ensuring that the future potential of nanotechnology is realized through sound governance, thoughtful decision-making, and public participation.

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