ENVIRONMENTAL HEALTH SCIENCES DECISION MAKING

Risk Management, Evidence, and Ethics

WORKSHOP SUMMARY

Yank Coble, Christine Coussens, and Kathleen Quinn, Rapporteurs

Roundtable on Environmental Health Sciences, Research, and Medicine

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
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ENVIRONMENTAL HEALTH SCIENCES DECISION MAKING Risk Management, Evidence, and Ethics WORKSHOP SUMMARY Yank Coble, Christine Coussens, and Kathleen Quinn, Rapporteurs Roundtable on Environmental Health Sciences, Research, and Medicine Board on Population Health and Public Health Practice

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THE NATIONAL ACADEMIES PRESS • 500 FIFTH STREET, N.W. • Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. Support for this project was provided by the National Institute of Environmental Health Sciences, National Institutes of Health (Contract N01-OD-4-2193, TO#43); National Center for Environmental Health and the Agency for Toxic Substances and Disease Reg- istry, Centers for Disease Control and Prevention (Contract No. 200-2000-00629, TO#7); National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention (Contract 0000166930); National Health and Environment Effects Research Laboratory and the National Center for Environmental Research, U.S. Environmental Protection Agency (Contract 282-99-0045, TO#5); American Chemistry Council (unnum- bered grant); ExxonMobil Corporation (unnumbered grant); and Institute of Public Health and Water Research (unnumbered grant). The views presented in this book are those of the individual presenters and are not necessarily those of the funding agencies or the Institute of Medicine. International Standard Book Number-13: 978-0-309-12454-6 International Standard Book Number-10: 0-309-12454-9 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www. iom.edu. Copyright 2009 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2009. Environmental Health Sciences Decision Making: Risk Management, Evidence, and Ethics: Workshop Summary. Wash- ington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Advising the Nation. Improving Health.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a man- date that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examina- tion of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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ROUNDTABLE ON ENVIRONMENTAL HEALTH SCIENCES, RESEARCH, AND MEDICINE Paul Grant Rogers, deceased, (Chair), Partner, Hogan & Hartson, Washington, DC Lynn Goldman (Vice Chair), Professor, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD John M. Balbus, Director of Environmental Health Program, Environmental Defense Fund, Washington, DC Yank D. Coble, Immediate Past President, World Medical Association, Neptune Beach, FL Susan Dentzer, Health Correspondent and Head of the Health Policy Unit, The News Hour with Jim Lehrer, Public Broadcasting Station, Arlington, VA Henry Falk, Director, Coordinating Center for Environmental and Occupational Health and Injury Prevention, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Atlanta, GA Richard Fenske, Professor, Department of Environmental Health, University of Washington School of Public Health and Community Medicine, Seattle Howard Frumkin, Director, National Center for Environmental Health/ Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Atlanta, GA Peggy Geimer, Corporate Medical Director, Arch Chemicals, Inc., Greenwich, CT Bernard Goldstein, Professor, Department of Environmental and Occupational Health, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA Myron Harrison, Senior Health Adviser, ExxonMobil, Inc., Irving, TX Carol Henry, Retired Vice President for Industry Performance Programs, American Chemistry Council, Arlington, VA John Howard, Director, National Institute of Occupational Safety and Health, Centers for Disease Control and Prevention, Washington, DC Sharon Hrynkow, Associate Director, National Institute of Environmental Health Sciences, National Institutes of Health, Bethesda, MD Richard Jackson, Graham Family Professor, School of Public Health, Director of the Graham Environmental Sustainability Institute, University of Michigan, Ann Arbor Floyd Malveaux, Executive Director, Merck Childhood Asthma Network, Inc., Washington, DC Michael McCally, Executive Director, Physicians for Social Responsibility, Washington, DC Mark Myers, Director, United States Geological Survey, Reston, VA Martin Philbert, Associate Dean for Research, School of Public Health, University of Michigan, Ann Arbor v

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Lawrence Reiter, Director, National Exposure Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC Leona Samson, Professor, Center for Environmental Health Sciences, Massachusetts Institute of Technology, Cambridge Paul Sandifer, Senior Scientist for Coastal Ecology, National Ocean Service, National Oceanic and Atmospheric Administration, Charleston, SC Carlos Santos-Burgoa, General Director for Equity and Health, Secretaria de Salud de Mexico, Mexico D.F. John Spengler, Professor, Department of Environmental Health, Harvard School of Public Health, Cambridge, MA William Suk, Acting Deputy Director, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC Louis Sullivan, President Emeritus, Morehouse School of Medicine, Atlanta, GA William Sullivan, Director, Department of Natural Resources and Environmental Sciences, University of Illinois at Urbana-Champaign, Urbana, IL Jennie Ward-Robinson, Executive Director, Institute for Public Health and Water Research, Chicago, IL Samuel Wilson, Acting Director, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC Harold Zenick, Director, Office of Research and Development, U.S. Environmental Protection Agency, National Health and Environmental Effects Research Laboratory, Research Triangle Park, NC Roundtable Staff Christine M. Coussens, Study Director Nora Hennessy, Senior Program Associate Tia Carter, Senior Program Assistant (until February 2008) Louise Jordan, Senior Program Assistant (from February 2008) Rose Marie Martinez, Board Director Hope Hare, Administrative Assistant Christie Bell, Financial Associate Kathleen Quinn, Intern (Spring 2008) *The members of the Roundtable on Environmental Health Sciences oversaw the planning of the workshop but were not involved in the writing of the workshop summary. vi

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s (NRC’s) Report Review Commit- tee. The purpose of this independent review is to provide candid and critical com- ments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: George Corcoran, Society of Toxicology, Wayne State University, Detroit, MI Betty Dabney, Maryland Institute for Applied Environmental Health, University of Maryland School of Public Health, College Park Stephen Lester, Center for Health, Environment, and Justice, Falls Church, VA Although the reviewers listed above have provided many constructive com- ments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Melvin Worth, Sun City, FL. Appointed by the NRC and the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authors and the institution. vii

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Contents PREFACE xi SUMMARY 1 1 APPROACHES TO DECISION MAKING 9 Human–Environment Network: Challenges to Environmental Health, 9 Alternatives Assessment as a Strategy for Decision Making, 14 Beyond Precaution, 16 2 SCIENTIFIC ISSUES IN ENVIRONMENTAL HEALTH DECISION MAKING 21 Evaluating Weights of Evidence for Decision Making, 21 The Role of Uncertainty and Susceptible Populations in Environmental Health Decision Making, 24 The Use and Misuse of Science in Decision Making, 28 Rationale for Revisiting an Environmental Health Decision: The National Toxicology Program, 29 Session Discussion: Weight of the Evidence in Science Versus Law, 32 3 CONFLICTS OF INTEREST, BIAS, AND ETHICS 35 General Observations Regarding Conflicts of Interest, 35 Managing Conflicts of Interest: The International Agency for Research on Cancer, 38 Session Discussion: Conflicts of Interest in the Current Research Climate, 42 ix

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x ContEntS 4 STAKEHOLDER PERSPECTIVES ON ENVIRONMENTAL HEALTH SCIENCES DECISION MAKING 45 Full Disclosure of Conflicts of Interest, 45 The Credibility of Science, 46 Asymmetry in Decision Making, 47 Data Development for Risk Assessment, 47 5 GENERAL WORKSHOP DISCUSSION 49 Transparency, 49 The Context Around Conflict and Evidence, 49 Code of Ethics, 50 Future Directions, 50 6 CLOSING COMMENTS 53 REFERENCES 57 APPENDIXES A Workshop Agenda 59 B Speakers and Panelists 63 C Workshop Participants 75

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Preface Environmental health decision making can be a complex undertaking, as there is the need to navigate and find balance among three core elements: sci- ence, policy, and the needs of the American public. Much of environmental health decision making started in the 1950s and 1960s and was focused on health effects of simple environmental exposures. However, scientific knowledge has rapidly changed as new technologies and new insights into the complexity of environment–health interactions have emerged. Furthermore, while much of environmental health has focused on population research, there is a call from the public for more individualized and tailored science. Incorporating these new evolutions means there is a greater need to make evidence-based decisions in a careful, considerate, yet timely manner. The ability to do so can, at times, be complicated and therefore dictates the constant exploration and reevaluation of the decision-making process. The 1960s and 1970s saw a strengthening of the nation’s commitment to environmental health sciences with the establishment of a number of agen- cies, such as the Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences, the National Toxicology Program, and the National Center for Environmental Health at the Centers for Disease Control and Prevention (CDC). These governmental agencies formed the core environmental health science programs and, in collaboration with other partners in the govern- ment, addressed the problems of the day by identifying the state of the science and the research gaps to better inform policy decisions. A more complete scientific picture enables policies that can help prevent harmful exposure and promote beneficial environments. The goal of sound deci- sion making is to ensure that science is the underlying backbone of policy. However, there are a number of unanswered questions about how to appropri- ately use science, including how much science is needed in order to take action, which chemicals should be subjected to further scrutiny, and how conflicts in xi

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xii pREfaCE the research literature should be resolved. At times, these unanswered questions result in a gulf between research and policy due to uncertainty, for example in extrapolating from evidence derived at high doses to determine low-dose risks. As a former policy maker, I know that science, risk, and policy are inter- twined. In the 1970s, the House Committee on Health and the Environment was debating the safety of saccharin as an artificial sweetener. The initial reports at the time designated saccharin as a carcinogen, but only if an individual consumed between 150 and 300 bottles of soda pop a day. Well, the committee decided that was not very likely and delisted it. What this example illustrates is the need for policy to be based on science, but the science needs to be interpreted in the appro- priate context that incorporates public use or exposure. It is interesting that this one example continued to be debated in the scientific and policy arenas into the late 1990s. Even at this workshop (held in 2008), the roundtable discussed how the science evolved to more fully understand the carcinogenicity of saccharin. Scientists have a more complete understanding of this one chemical based on a number of research studies to elucidate cellular mechanisms. Policy makers often grapple with how to make appropriate decisions when the research is uncertain. For example, when the Clean Air Act was being drafted, various groups of scientists had conflicting positions about whether to include carbon dioxide or ozone as air pollutants, but the House committee partially based its decisions on the death rates and hospital admission rates from pollution in such places as California and Denver. The legislators did not want to wait to count bodies and instead made a judgment to remove the impurities that were causing adverse health effects. The challenge for the policy maker is to make the right decision with the best available data in a transparent process. The Institute of Medicine’s Roundtable on Environmental Health Sciences, Research, and Medicine was established in 1988 as a mechanism for bringing various stakeholders together to discuss environmental health issues in a neutral setting. Roundtable members represent the academic community, industry, non- governmental organizations, governmental agencies, and health professions. The roundtable provides an environment that fosters scientific dialogue on current and emerging issues in the field of environmental health. The purpose is to illuminate ideas and facilitate discussion. However, the members do not resolve issues or make recommendations. The workshop on which this volume is based was held on January 15, 2008, in Washington, DC. This workshop was designed to address the scientific and ethical foundation of environmental health decision making. It included an overview of the principles underlying decision making, the role of evidence and challenges for vulnerable populations, and ethical issues of conflict of interest, scientific integrity, and transparency. The workshop engaged science interest groups, industry, government, and the academic sector through three sessions of speaker presentations, with each session being concluded with a general discus-

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xiii pREfaCE sion. The reader can find the workshop agenda, as well as speaker information and a list of attendees in the appendixes at the end of this summary. This workshop summary which was written by the named rapporteurs, cap- tures the discussions and presentations by the speakers and panelists. The infor- mation expressed here is the views of the individuals and should not be perceived as a consensus of the participants or the views of the roundtable, the Institute of Medicine, or its sponsors. Paul G. Rogers, J.D., Chair Roundtable on Environmental Health Sciences, Research, and Medicine

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