“yg i LAh y went ™ : + 1. H] t ¢ \ ? ‘ - ‘ \ ’ i ‘ % i “f \A L ‘ ‘- > \ : « 4 ft ad ( ef | * ‘ U.S.CONGRESS ' .. | OFFICE OF . TECHNOLOGY ~ | ASSESSMENT | ‘Technology Assessment Board of the 103d Congress EDWARD M. KENNEDY, Massachusetts, Chairman DON SUNDQUIST, Tennessee, Vice Chairman SENATE HOUSE ERNEST F. HOLLINGS, South Carolina GEORGE E. BROWN, JR., California CLAIBORNE PELL, Rhode Island JOHN D. DINGELL, Michigan ORRIN G. HATCH, Utah JIM McDERMOTT, Washington CHARLES E. GRASSLEY, Iowa rN( Od s (@1ULC] nO) \ Pa( nna Core DYNA = 910) 5)= 1)\| =)= n (Cl= a Pam\ye lnaoe! MICHAEL G. OXLEY, Ohio ROGER C. HERDMAN Technology Assessment Advisory Council NEIL E. HARL, Chairman MAX LENNON Charles F. Curtiss Distinguished Professor President, Clemson University Iowa State University Clemson, South Carolina Ames, lowa THOMAS J. PERKINS JAMES C. HUNT, Vice Chairman General Partner Distinguished Professor, Health Sciences Center Kleiner, Perkins, Caufield and Byers ; University of Tennessee San Francisco, California Memphis, Tennessee CHASE N. PETERSON CHARLES A. BOWSHER President Emeritus and Professor Comptroller General of the United States University of Utah Salt Lake City, Utah Washington, D.C. LEWIS M. BRANSCOMB WILLIAM H. ROBINSON Director, Science, Technology & Public Acting Director, Congressional Research Service Policy Program, Harvard University The Library of Congress Washington, D.C. Cambridge, Massachusetts Be HERBERT (TED) DOAN JOHN F.M. SIMS ._. President (Ret.), The Dow Chemical Company Vice President, Marketing : Midland, Michigan Usibelli Coal Mine, Inc. Fairbanks, Alaska JOSHUA LEDERBERG MARINA v.N. WHITMAN Professor, Rockefeller University Professor, Institute of Public Policy Studies . New York, New York University of Michigan Ann Arbor, Michigan The Technology Assessment Board approves the release of this report. The views expressed in this report are not necessarily those of the Board, OTA Advisory Council, or individual members thereof. ML 22501864284 NKTOWOINLNIDSOIWWLN OOdUI ANS U.S. CONGRESS INFORM?" CENTRE ere ne or TECHNOLOGY vi 12 OFT 1994 540: ASSESSMENT —— Wellcome Ce: uical Science F erates Recommended Citation: U.S. Congress, Office of Technology Assessment, Researching Health Risks, OTA-BBS-570 (Washington, DC: U.S. Government Printing Office, November 1993). a ae eA Ry i) ee a Pe el A a For sale by the U.S. Government Printing Office ¢ Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328 ISBN 0-16-043021-6 oreword n everyday life, we evaluate the risks associated with various activities and make choices, considering such things as benefits, costs, convenience, and past experience. As a society, we must make similar choices. The process of health risk assessment can help guide the decisions necessary for living in a world full of chemicals, radiation, and fibers, both natural and manufactured. Risk assessment illuminates the hazards that result from exposure to a substance and the magnitude of the risk associated with different levels of exposure. Results of health risk assessments are used as one of the inputs in formulating regulatory decisions. Those decisions affect expenditures for regulatory compliance or treating exposure- related diseases that can total billions of dollars. Because of the public health and economic implications of risk assessments, Congress has grown increasingly interested in the accuracy and scientific underpinning of risk assessment. An indication of this interest was the request by the House Energy and Commerce Committee and the House Science, Space, and Technology Committee to the Office of Technology Assessment (OTA) to analyze the nature, organization, and management of federally supported research on health risk assessment. This focus is important because such research provides the scientific foundation for health risk assessments. In this report, OTA describes the Federal Government’s research activities that are intended to improve health risk assessments. One of the findings of this Report is that the attention and resources allotted to health risk assessment research are not commensurate with its national impact. A particular problem is that research is fragmented within and across the Federal agencies, greatly complicating setting research priorities. Consequently, the agencies are not focusing on areas of research likely to have the most far-reaching effect on policy—especially risk assessment methodology—and they are unable to harness fully the rapid advances in the basic biological and biomedical sciences. Many individuals and institutions contributed their time and expertise to this project. Experts from government, industry and academia served on the project’s advisory panel and workshop on research structure and organization and reviewed drafts of chapters and the full report. OTA gratefully acknowledges their contributions and assistance. As with all OTA analysis, however, responsibility for the content is OTA’s alone. PI GLO Roger C. Herdman, Director Avisos Panel Ronald W. Estabrook, Panel Chair The University of Texas Southwestern Medical Center Dallas, Texas Eula Bingham Colin N. Park University of Cincinnati _ The Dow Chemical Co. Cincinnati, OH Midland, MI Thomas A. Burke David P. Rall The Johns Hopkins University Washington, DC Baltimore, MD Joseph V. Rodricks Adam M. Finkel ENVIRON Corp. Resources for the Future Arlington, VA Washington, DC Curtis C. Travis Joseph H. Guth Oak Ridge National Laboratory Natural Resources Defense Council, Inc. Oak Ridge, TN New York, NY James D. Wilson Oliver Hankinson Monsanto Co. University of California, Los Angeles St. Louis, MO Los Angeles, CA Lauren Zeise David Lilienfeld California Environmental Protection Agency EMMES Berkeley, CA Potomac, MD Rae Zimmerman Gilbert S. Omenn New York University University of Washington New York, NY Seattle, WA NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the advisory panel members. The panel does not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and the accuracy of its contents. iv / roject Staff Clyde J. Behney PRINCIPAL STAFF ADMINISTRATIVE STAFF Assistant Director DALTON PAXMAN Cecile Parker Health, Life Sciences, Project Director Office Administrator and the Environment Margaret McLaughlin Linda Journiette-Rayford Michael Gough Project Director! PC Specialist Program Manager Margaret Chu Jene Lewis Biological and Behavioral Sciences Senior Science Fellow (EPA) Administrative Secretary Ginger Roehrig PUBLISHING STAFF Research Assistant CONTRACTORS Mary Lou Higgs Kerry Conroy Manager, Publishing Services Leah Mazade Intern? Editor Denise Felix Washington, DC Production Editor John Hall Miriam Davis Intern* Cheryl Davis Washington, DC Typographer Terri Smith George Gray Susan Hoffmeyer Harvard University Intern Graphic Designer Boston, MA CONTRIBUTORS William Pease University of California Hugh L. Spitzer Berkeley, CA International Life Sciences Institute Sandy Weiner Risk Sciences Institute Massachusetts Institute for Technology Jill S. Litt 1Through May 1992. Cambridge, MA International Life Sciences ?Through May 1993. Institute 3Through August 1993. Risk Sciences Institute Through March 1993. orkshop Participants Thomas Burke, Workshop Co-chair lra Raskin Department of Health Policy and Management Center for Medical Effectiveness Research The Johns Hopkins University U.S. Department of Health and Human Services Baltimore, MD Rockville, MD Rae Zimmerman, Workshop Co-chair John Vandenberg Robert F. Wagner Graduate School of Public Service Health Effects Research Laboratory New York University U.S. Environmental Protection Agency New York, NY Research Triangle Park, NC Marvin Cassman Dan Vandermeer National Institute of General Medical Sciences National Institute of Environmental Health Sciences National Institutes of Health U.S. Department of Health and Human Services Bethesda, MD Research Triangle Park, NC Irwin Feller Jeanette Wiltse Graduate School of Public Policy and Adminstration Office of Health Effects Assessment The Pennsylvania State University U.S. Environmental Protection Agency University Park, PA Washington, DC | Carolyn Fulco Frank E. Young National Academy of Sciences U.S. Department of Health and Human Services Washington, DC Washington, DC Bryan Hardin National Institute for Occupational Safety and Health U.S. Department of Health and Human Services Washington, DC ~ NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the workshop participants. The participants do not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and the accuracy of its contents. Vi yi ontents 1 Summary, Issues and Options 1 Health Risk Assessment Research at Federal Agencies 3 Linking Health Risk Research to Decisionmaking 12 Prospects for the Future 19 Introduction to Issues and Options 20 Issues in Health Risk Research, Structure and Funding 22 Issues in Linking Research to Decisionmaking (Radon as a Case Study) 36 2 An Introduction to Health Risk Assessment and Its Research Base 45 Research Data for Health Risk Assessment 48 The Health Risk Assessment Process 50 Issues in Health Risk Assessment 54 Why Conduct Risk Assessment Research? 60 Summary 63 Chapter 2 References 63 3 Federal Research in Health Risk Assessment 67 Research at the Federal Agencies 67 Trends and Gaps _ 81 Summary 83 Chapter 3 References 83 4 Setting Priorities for Risk Assessment Research 87 Categorizing Health Risk Assessment Research 88 Federal Resources for Health Risk Assessment Research 93 National Research Priorities 98 Agency Priorities 102 Programmatic Priorities and Program Management 108 Administrative Tools for Priority-Setting 109 Findings and Conclusions 112 Chapter 4 References 115 vii 5 Research and Decisionmaking 119 Impact of Research on Risk Assessment Guidelines and Decisionmaking 120 The Interdependency of Research and Decisionmaking 130 The Limits of Science in Social Decisions 133 , Linking Health Risk Research to Decisionmaking 137 Summary 140 Chapter 5 References 141 6 Indoor Radon: A Case Study in Decisionmaking 145 How Large Is the Waterborne Radon Problem? 146 Radon, Mining, and Indoor Exposures 146 Epidemiologic Studies of Radon-Related Lung Cancer 149 Policy 154 The Future 165 Chapter 6 References 167 7 Structuring the Future of Health Risk Assessment Research 171 Structuring a High-Quality Research Program 172 Prospects for Research 174 Fostering Research Linkages 181 Summary and Conclusions 183 Chapter 7 References 184 APPENDIXES A International Risk Assessment 187 B Department of Health and Human Services Organization Chart 211 C Federal Obligations for Health R&D by Source or Performer 212 D FY 1992 Estimates of Funding Support by DHHS Agencies 214 List of Abbreviations 216 Acknowlegments 220 INDEX 225 Vili