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Understanding 1` ~ 1< ... . . .. Informing Decisions in a Democratic Socief' Paul C. Stern and Harvey V. Fineberg, editors Committee on Risk Characterization Commission on Behavioral and Social Sciences and Education National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1996

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NATIONAL ACADEMY PRESS 2101 Constitution Ave., N.W. Washington, D.C. 20418 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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to proce- dures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This material is based on work supported by the U.S. Department of Agriculture, Agricultural Research Service, under Agreement No. 59-0700-3-078; by the U.S. Nuclear Regulatory Commission under Award No. NRC-04-93-070 (opinions, findings, conclusions, and recommendations expressed herein are those of the authors and do not necessarily reflect the views of the Nuclear Regulatory Commission); and by the U.S. Departments of Defense, Energy, and Health and Human Services; the U.S. Environmental Protection Agency; the American Industrial Health Council; and the Electric Power Research Institute. Library of Congress Cataloging-in-Publication Data Understanding risk: information decisions in a democratic society / Paul C. Stern and Harvey V. Fineberg, editors. p. cm. "Committee on Risk Characterization. Commission on Behavioral and Social Sciences and Education. National Research Council." Includes bibliographical references and index. ISBN 0-309-05396-X 1. Risk assessment. 2. Policy sciences. I. Stem, Paul C., 1944- . II. Fineberg, Harvey V. III. National Research Council (U.S.). Committee on Risk Characterization. IV. National Research Council (U.S.). Commission on Behavioral and Social Sciences and Education. HM256.U53 1996 302'.12 dc20 96-16152 CIP Understanding Risk: Informing Decisions in a Democratic Society is available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, D.C. 20055. Call 800-624-6242 or 202-334-3313 (in the Washington Metropolitan Area). Copyright 1996 by the National Academy of Sciences. All rights reserved

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COMMITTEE ON RISK CHARACTERIZATION HARVEY V. FINEBERG (Chair), Harvard School of Public Health JOHN AHEARNE, Sanford Institute of Public Policy, Duke University, and Sigma Xi Center, North Carolina THOMAS BURKE, School of Hygiene and Public Health, Johns Hopkins University CARON CHESS, Center for Environmental Communication, Rutgers University BRENDA DAVIS, Johnson & Johnson Health Care Systems, Iliac., Piscataway, New Jersey PETER DEFUR, Environmental Defense Fund, Washington, D.C. JEFFREY HARRIS, Department of Economics, Massachusetts Institute of Technology MARK HARWELL, Rosensteil School of Marine and Atmospheric Science, University of Miami SHEILA [ASANOFF, Department of Science and Technology Studies, Cornell University NAMES LAMB, lellinek, Schwartz & Connolly, Washington, D.C. D. WARNER NORTH, Decision Focus, Inc., Mountain View, California, and Department of Engineering-Economic Systems, Stanford University KRISTIN SHRADER-FRECHETTE, Department of Philosophy and Program in Environmental Sciences and Policy, University of South Florida PAUL SLAVIC, Decision Research, Eugene, Oregon, and Department of Psychology, University of Oregon MITCHELL SMALL, Departments of Civil and Environmental Engineering and Department of Engineering and Public Poliev. ~ ~ , Carnegie Mellon University ELAINE VAUGHAN, School of Social Ecology, University of California, Irvine {AMES WILSON, Resources for the Future, Washington, D.C. LAUREN ZEISE, California Environmental Protection Agency, Berkeley PAUL C. STERN, Study Director SARAH CONNICK, Senior Staff Officer THOMAS WEBLER, Consultant MARY E. THOMAS, Senior Program Associate . . . [I!

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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 fur- therance 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 mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts 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 achieve- ments of engineers. Dr. Harold Liebowitz is president of the National Academy of Engi- neering. 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 examination of policy matters pertaining to the health of the public. The Institute acts under the responsi- bility 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. Kenneth I. Shine 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 scien- tific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Harold Liebowitz are chairman and vice chairman, respectively, of the National Research Council.

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Acknowledgments Throughout our work together, the committee benefited from the efforts of an extremely dedicated staff. As project director, Paul Stern often took the lead in reconciling and expressing the views of committee members and played a substantial role in crafting this report. Tom Webler, consultant to the committee, contributed his ideas and valuable draft materials. Eugenia Grohrnan, associate director of reports of the Commission on Behavioral and Social Sciences and Education, lent en- couragement, helped streamline our report, and made it more readable. Mary Thomas ably managed our logistic arrangements and communica- tions. Sarah Connick provided valuable assistance in getting the commit- tee started on its work. The committee was aided in its deliberations by the testimony and advice of many knowledgeable and experienced individuals. The com- mittee acknowledges with appreciation their presentations to the com- mittee: Alwynelle Ahl, Agricultural and Plant Health Inspection Service, U.S. Department of Agriculture Calvin Bey, Forest Service, U.S. Department of Agriculture Elinor Blake, Executive Assistant, Hazardous Material Commission, Contra Costa County, California Michael Brody, Office of Policy, Planning and Evaluation, U.S. Environmental Protection Agency Joseph Catruvo, U.S. Environmental Protection Agency v

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Vl A CKNOWLEDGMENTS Mark Cunningham, U.S. Nuclear Regulatory Commission Lynn Desautels, Office of Policy, Planning and Evaluation, U.S. Environmental Protection Agency Adam Finkel, Resources for the Future Michael Firestone, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency George Fries, Agricultural Research Service, U.S. Department of Agriculture Philip Harter, attorney, Washington, D.C. Carol Henry, U.S. Department of Energy Gordon Hester, Electric Power Research Institute Karen L. Hulebak, U.S. Food and Drug Administration Carolyn Leep, Chemical Manufacturers Association Ray Kent, U.S. Environmental Protection Agency Carl Mazza, Office of Air and Radiation, U.S. Environmental Protection Agency Hugh McKinnon, U.S. Environmental Protection Agency Michael Pompili, Assistant Commissioner of Health, Columbus, Ohio Greg Schirm, Director, Delaware Valley Toxics Coalition Donald Stevenson, American Industrial Health Council We also thank John Lathrop of Strategic Insights for his contributions to the case study on the Florida Power Corporation (in Appendix A).

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Contents PREFACE SUMMARY THE IDEA OF RISK CHARACTERIZATION Beyond Translation, 14 Participation and Knowledge in Risk Decisions, 23 An Expanded Framework, 27 2 JUDGMENT IN THE RISK DECISION PROCESS Problem Formulation, 38 Selection of Options and Outcomes, 42 Information Gathering and Interpretation, 50 Synthesis, 56 Conclusion: The Importance of Process Design, 70 3 DELIBERATION Role of Deliberation, 74 Purposes of Broadly Based Deliberation, 79 Limitations and Challenges, 82 Standards and Goals for Deliberation, 86 vat 1X 1 11 37 73

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. . . V111 4 ANALYSIS Purposes and Challenges of Analysis, 98 Standards for Good Analysis, 100 Analysis to Reduce the Complexity of Risk, 102 The Analysis of Uncertainty, 106 Conclusions, 116 INTEGRATING ANALYSIS AND DELIBERATION Problem Formulation, 120 Process Design, 122 Selection of Options and Outcomes, 124 Information Gathering and Interpretation, 126 Synthesis of Information, 127 Achieving Closure, 129 Conclusion, 131 6 IMPLEMENTING THE NEW APPROACH Practicality, 133 Diagnosis: Matching the Process to the Decision, 137 Building Organizational Capability, 150 Conclusion, 154 PRINCIPLES FOR RISK CHARACTERIZATION APPENDICES CONTENTS 97 118 133 155 SIX CASES IN RISK ANALYSIS AND CHARACTERIZATION 167 Application of Ecosystem Management Principles for the Sustainability of South Florida, 167 Approval of the Waste Technologies, Inc. Incinerator at East Liverpool, Ohio, 176 Regulatory Negotiation for a Disinfectant By-Products Rule, 179 Siting a Power Plant with the Aid of Decision Analysis Tools, 188 The California Comparative Risk Project, 193 Planning Future Land Uses at Hanford, Washington, 196 B COMMON APPROACHES TO DELIBERATION AND PUBLIC PARTICIPATION C BIOGRAPHICAL SKETCHES GLOSSARY REFERENCES INDEX 199 207 214 217 241

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Preface For decades the National Research Council has been called on to consider how to improve decisions about risks to public health, safety, and environmental quality. The Research Council has responded with a series of studies that reflect the history of thinking about how society can understand and cope with those risks. Risk Assessment in the Federal Gov- ernment: Managing the Process reported the results of a study that sought "institutional mechanisms that best foster a constructive partnership be- tween science and government" for informing contentious public deci- sions about hazards to human health from exposures to toxic substances (National Research Council, 1983:1~. The study is best known for popu- larizing the distinction between risk assessment and risk management and raising the issue of how best to keep these functions separate, yet coordinated. Several years later, Improving Risk Communication focused on the rela- tionship between producers and users of scientific information about risks, addressing ways to improve communication "in the service of pub- lic understanding and better-informed individual and social choice" (Na- tional Research Council, 1989:x). More recently, Building Consensus Through Risk Assessment and Management of the Department of Energy's En- vironmental Remediation Program considered links between risk assessment and public participation. It sought ways to "conduct a credible risk as- sessment of all the risks at all the sites twhere the Department was mak- ing restoration after use in the nuclear weapons program], with active participation of all the local participants" (National Research Council, IX

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x PREFACE 1994b:vii). At the same time, Science and judgment in Risk Assessment addressed the generic problem of establishing and, when appropriate, changing guidelines for assessing human health risks in ways that deal appropriately with the uncertainties of existing knowledge and the needs of decision makers (National Research Council, 1994a). Like these previous studies, the present one addresses a broad issue linking risk science and policy. The initial charge formulated the problem as follows: The way the nation handles risk often breaks down at the stage of "risk characterization," when the information in a risk assessment is translat- ed into a form usable by a risk manager, individual decision maker, or the public. Oversimplifying the science or skewing the results through selectivity can lead to the inappropriate use of scientific information in risk management decisions, but providing full information, if it does not address key concerns of the intended audience, can undermine that au- dience's trust in the risk analysis. This problem was of sufficiently broad interest that the study received support from the U.S. Departments of Defense, Health and Human Ser- vices, Agriculture, and Energy, the U.S. Environmental Protection Agency (EPA), the U.S. Nuclear Regulatory Commission, the American Industrial Health Council, and the Electric Power Research Institute. In some of the departments and agencies, the interest and support came from several major internal units. Thus, we were asked to address concerns of entities as diverse as the Centers for Disease Control and Prevention, the Agricul- tural and Plant Health Inspection Service, civilian and defense organiza- tions responsible for radioactive waste management, the Food and Drug Administration, and EPA's Office of Prevention, Pesticides, and Toxic Substances. To carry out this broad task, the Research Council convened a com- mittee of 17 members from a variety of specialties including risk assess- ment, epidemiology, toxicology, ecology, public policy, economics, deci- sion science, social science, medicine, public health, and law. Members were selected to ensure that the perspectives of federal and state regula- tory agencies, industry, and environmental and citizens groups would be included, along with those of scientists. And members were selected so as to assure a flexible view of the charge and to provide an overall balance to the committee. Biographical sketches are provided in Appendix C. At its initial meetings the committee heard from each of its sponsors and considered a detailed letter from representatives of most of the spon- soring agencies that presented a considerably broader reading of the charge, which appears to restrict "risk characterization" to the translation of scientific information already available from risk assessments. In par- ticular, the letter called on the committee to "consider the appropriate

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PREFACE Xl ness of including in risk characterizations" such considerations as "eco- nomic factors, equity issues, risk mitigation and tradeoffs, and technical control feasibility," as well as "environmental-equity issues and other issues of social context," considerations not normally included in risk assessments. The letter also called on the committee for "guidance . . . to improve the dialogue between risk assessors and risk managers prior to and during the development of a comprehensive assessment so that policy and management concerns are understood by all parties." This request implicitly recognized the importance to risk characterization of commu- nication before and during the process of conducting risk assessments, not only after they are complete. Some of the sponsors, particularly the Department of Energy, also indicated that concerns about improving pub- lic participation, building trust, and similar ;.s~sue.s wore among tho.~ that had led them to support the study. As a result of discussion of these concerns with the sponsors' repre- sentatives, the committee adopted a revised task statement that reflected a broader charge: "Risk characterization" is a complex and often controversial activity that is both a product of analysis and dependent on the processes of defining and conducting analysis. The study committee will assess opportunities to improve the characterization of risk so as to better inform decision making and resolution of controversies over risk. The study will ad- dress: technical issues such as the representation of uncertainty; issues relating to translating the outputs of conventional risk analysis into non- technical language; and social, behavioral, economic, and ethical aspects of risk that are relevant to the content or process of risk characterization. This charge makes explicit that the committee would consider both trans- lation issues and those processes that determine whether risk character- izations ultimately better inform decision making. The revised charge represents the first step in defining the committee's view of its topic that is reflected in the use of the term "understanding risk" in the title of this volume. The committee held an informal meeting in March 1994 and six meet- ings between May 1994 and June 1995 to gather and consider information and to write its report. It engaged in discussions with sponsors' represen- tatives and a variety of outside scientists and risk practitioners whose experiences with risk characterizations the committee believed would be instructive. It sought knowledge from various sources, including experi- mental research on risk perception and methods of summarizing risk information; studies that evaluate the effects and outcomes of various ways of analyzing and deliberating about risk; and the reflections of expe- rienced practitioners of risk assessment, characterization, and decision making. The committee discussed a wide range of risks, including risks . . ~

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. . X11 PREFACE to human health and safety, the environment, and ecosystems and risks from chemicals, foods, ionizing radiation, electromagnetic fields, people's own behavior, exotic organisms or biological materials, and global cli- matic change. It discussed a wide range of uses for risk characterization, including: informing regulatory decisions on approving drugs, chemi- cals, and vaccines; setting chemical exposure standards; setting priorities for public expenditures on risk reduction; informing populations at risk from hazardous substances, infectious disease, or their own behavior; and informing legislative debates. Given the variety of sponsors, risks, and decision situations, the com- mittee emphasized broad considerations about risk characterization rather than those that are specific to certain risks, decision types, or government agencies. It developed consensus about how to think about and organize risk characterization efforts, without trying to offer detailed guidance for particular decision contexts. While reviewing comments on its draft re- port, the committee learned that the congressionally mandated Commis- sion on Risk Assessment and Risk Management will propose a frame- work that similarly emphasizes the importance of coupling analysis with the participation of interested and affected parties. The committee wel- comes this reinforcement and views its main ideas and conclusions as building on the foundation of previous efforts, including the Research Council reports mentioned above and the work of many others to im- prove ways of coping with risk situations. If its recommendations can be implemented with appropriate deliberation and judgment, the committee believes that more understandable, scientifically sound, and acceptable decisions will result. The committee stresses to the readers of this report our conviction that no set of guidelines or procedures can ever substitute for scientific rigor, fairness, and flexibility in coping with dynamic risk situations. Yet we do hope our findings and recommendations will aid those of good will to make sounder decisions about risks. HARVEY V. FINEBERG, Chair Committee on Risk Characterization

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Understanding ~ . _ ' 1<

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