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Risk Assessment in the Federal Government: Managing the Process Committee on the Institutional Means for Assessment of Risks to Public Heady Commission on life Sciences National Research Council N~TIONAI, ACADE\IY PRESS Washington. D. C. 1983

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NOTICE:: The project chat is the subject of this report was approved by the Governing Board of Me Nat~or~a' Research Council, whose members are drawn from Me councils of the National Academy of Sciences, Me National Academy of Engineering, and Me Institute of medicine. Me members of Me committee responsible for Me report were chosen for their specie' c~petences and with regard for appropriate Mace. This report As been reviewed by a Cup other than the authors according to procedures approved by a Report Review Tee consisting of members of the National Academy of Sciences, the Nation?, Academy of Leering, ~~a the Institute of Medicine. The National Research Council was established by Me National Laded of Sciences ~ 1916 to associate Me broad community of science AL Necrology wit the Acad~y's purposes of furthering knowleilge add of advising He federal governs. Me Council operates in accos dance win general policies determined by the Ac:adem:? finder Me authority of its congressional charter of IBM, which es~1isI2es the Academy as a private, nonprofit, se~f~govers~sug membership corporation. Me Council has become the principal operating agency of both the Matio~1 Academy of Sciences Ad Me Nations Academy of Engineers in Me conduct of their services to Me government, Me public, a~ Me scientific Ad eng~ccrs~g cities. It is adm~stesed jointly by bow Academies Ad the Institute of Medicine. Me Station Academy of 33ngmeer~g Ad Me Institute of medicine were established ~ '964 ~ 1970, respectively, under Me charter of Me Nations A`:ade" of Sciences. The study reported here was supported by Contract 223-81-8251 between the Nation A-ad~q of Sciences arid Me Food ="d Drug AA-;ni~tration, Lear of mealy and Ion SerVic^C- Library of Congress Catalog C=d N~er 83-80381 International' Seward Book tier 0-30903349-7 Avas' Thee from ACID Academy PRESS 2101 Constitution Avenue, B.W. Wash Goon, D.C . 20418 Panted in the United States of America First Printing, March 1983 Second Printing, October 1983 Third Printing, August 1984 Fourth Printing, June 1985 Fifth Printing, August 1987 Sixth Printing, May 1988 Seventh Printing, December 1989 Eighth Printing, July 1991 Ninth Printing, March 1992 Tenth Printing, February 1993 Eleventh Printing, May 1994 Twelfth Printing, July 1995 Thirteenth Printing, October 1996

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N AT ~ O N AL RES E ARC H CO U ~ C I L 2101 CON'S=UTSO~' BE =^SHI~'CON', D. C. 20~8 OF-;C_ O- TH-- CHAIRMAN' Arthur Hull Hayes, Jr., M. D. Co~unissione' of Food and Drugs Food and Drug Administration 5 6 0 0 F ~ sheds Lane Rockvil le. MD 20857 Dear Dr. Hayes: March 1, 19 8 3 ~ am pleased to transit t the enclosed report entitled "Risk Assessment in the Federal Government : Managing the Process. n This study was authorized by P.~. 96-528 and carried out by a committee of the Nati onal Research Council's Commission on Life Sciences with support from the Food and Drug Administration under Contract No. 223-81-8251. The Congress made provision for this study to strengthen the reliability and objectivity of scientific assessment that forms the basis for federal regulatory policies applicable to carcinogens and other public health hazards. Federal agencies that perform risk assessments are often hand pressed to clearly and convincingly present the scientific basis for their regulatory decision. In the recent past, for example, decisions on saccharin, nitrites in food, formaldehyde use in home Insulations, asbestos, air pollutants and a host of other substances have been called Into question. The report recommends no radical changes ~n the organizational arrangements for perfo~`ing risk assess- ments. Rather, the committee f inds that the basic problem in risk assessment is the incompleteness of data, a problem not remedied by changing the organizational arrangement for performance of the assessments. instead, the committee has suggested a course of action to improve the process within the practice' constraints that exist. THE mnob<^L RESOW CO~C'L IS ME ~I~CiP~ OPEM=C SCENT or rue ^~< A~E' o. saExc~s ^= BE NA=0~ A~E' OF ~~EE~C TO SERB C0~ENT AND =HER OR~'=n0X'S.

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Arthur Hull Hayes, Jr., M.~. March 1, 1983 Page Two One proposal by the committee requires explanation. It would provide that there be established under Academy auspices a Board on Risk Assessment Methods. This recom- mendation emerges strictly from the committee ' s internal deliberation. The committee alone is responsible for the substantive contents and findings of the report. Were a request made to the Academy along the lines of that particular reco.~..endation to establish such a Board, the request would be considered de nova by the appropriate governing bodies of the inst' tut' on. Yours sincerely, Frank Press Chairman -

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Committee on the Institutional Means for Assessment of Risks to Public Health REUEL A. STALLONES, School of Public Health, University of Texas, Houston, Tex., Chairman MORTON CORN, Department of Environmental Health Sciences, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Md. KENNY S. CRUMP, Science Research Systems, Zinc., Ruston, La. J. CLARENCE DAVIES, Conservation Foundation, Washington, D.C. VINCENT P. DOLE, Rockefeller University, New York, N.Y. TED R. I. GREENWOOD, Department of Political Science, Massachusetts Institute of Technology, Cambridge, Mass. RICEARD A. =}~L;L, University of Virgin' a School of Law, Charlottesville, Va. FRANKLIN E. MIRE}l, Department of Heals and Safety, International Onion, UAW, Detroit, Mach. D. WARNER NOR=, Decision Focus, Inc., Los Altos, Calif. GILBERT S. OMENN, Department of Environmental }health, University of Washington School of Public Health and Community Medicine, Seattle, Wash. JOSEPH V. ROD}~CKS, ENVIRON Corporation, Washington, D.C. PAUL SLOVIC, Decision Research, A Branch of Perceptronics, Inc ., Eugene, Oreg . H. M. D. OTIWlAN, American Cyanamid Company, Wayne, N.J. ELIZAI3E~ WEISB~ER, National Cancer Institute, National Institutes of Health, Bethesda, Md. Staff LAWRENCE E . MCCRAY, Pro ject Director QY1HH}\INE Ilk Sat HILAIRE, Staff Officer WlI~LIAM M. STIGLIANI, Staff Officer =bE:E M. ST. PIERRE, Administrative Secretary NORMAN GROSSBLATT, Editor v

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Acknowledgments The Committee acknowledges with appreciation information provided by the following persons. KARIM ARMED, Research Director, Natural Resources Defense Council ELIZABETH ANDERSON, Director, Office of Health and Environmental Assessment, Environmental Protection Agency EDWIN L. BESRENS, Procter and Gamble Corporation (representing Ameri can Industrial Health Council) JACKSON B. BROWNING, Union Carbide Corporation (representing Chemical Manufacturers Association) WILLIAM D. CAREY, Executive Officer, American Association for the Advancement of Science PETER F. CARPENTER, Vice President for Corporate Strategy, Alma Corp., Palo Alto, Calif. (representing Pharmaceutical Manuf acturers Association) PAUL F. DEISLER, JR., Vice President, Health Safety and Environment, Shell Oil Company ROBERT I. FIELD, Research Associate, Analysis and Inf erence, Inc ., Boston, Mass. W. GAY IIAMM, Deputy Associate Commissioner for Health Affairs (Science) , Food and Drug Administration SHERWIN GARDNER, Vice President, Science and Technology, Grocery Manufacturers of America, Inc. MICHAEL GOUGH, Health Program Project Director, Office of Technology Assessment, U. S. Congress. THOMAS P. . GRYLY, Senior Consultant, Temple, Barker and S loan, Inc ., Lexington, Mass. PAUL T. HOPPER, General Foods Corporation, ( representing Soc ial and Economic Committee, Food Saf ety Counc i l) STY J. ICY, Assistant Professor, Howard University; and Senior Science Advisor, Clement Associates V11

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RAP=EL G. EASPER, Executive Director, Commission on Physical Sciences, Mathematics, and Resources, ~S-NBC ARNOLD M. EUZMACE, Chevy Chase, Md. RICEAPD LE=N, Director, Division of Standards Development and Technology Transfer, National Institute of Occupational Safety and Health 30HN M~ONIIC, Deputy Director of Bealth Standards Programs, Occupational Safety and Health Administration WILLIAM McCARV}~, Monsanto Co., (representing American Industrial Health Council) SANFORD A. MIr~r~R, Director, Bureau of Foods, Food and Drug Administration. PAUL MILVY, Envirormental Law Institute WARDEN R. FIR, Visiting Associate Professor, Department of Environmental Sciences, Johns Hopkins University DENIS PRAGER, Assistant Director for Life Sciences and Institutional Relations, Of f ice of Science and Technology Policy, Executive Office of the President PETER PH:IJSS, Associate Executive Director, Directorate of Bealth Sciences, Consumer Product Safety Commission DAVID BAIL, Director, National Institute of Environmental }health Sciences WILLIAM D. ROWE, Director, Institute for Risk Analysis; and Professor of Decision and Risk Analysis, American University JAllES H. SAMMONS, Executive Vice President, American Medical Association SHELDON SATCHELS, Director, Health Safety and Environmental Industrial Union Department, AFL/CID BRUCE SILVERGL~DE, Director for Legal Affairs, Center for Science in the Public Interest M. J. SLOAN, Manager, Regulatory Affairs, Shell Oil Company STEVEN M. SWENSON, Director, Health and Safety Regulation, American Petroleum Institute ROBE:RI G . TA - IT 1?, Executive Director, Board on Toxicology and Environmental Bealth Hazards, NAS-NRC MONTE: C. ~DABL, Monsanto Corporation (representing American Industrial Bealth Council) HAROLiD TRABOSEI, Deputy Director, Residue Evaluation and Surveillance Division, Food Safety Inspection Service, Department of Agriculture PEP. WILLIAM C. WALER (Do ), O.S. House of Representatives viii

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Preface In response to a directive f ram the Congress of the United States, the Food and Drug Administration contracted with the National Academy of Sciences to conduct a study of the institutional means for risk assessment. The Commit- tee on the Institutional Means for Assessment of Risks to Public Health was formed in the National Research Council's Commission on Life Sciences in October 1981 and completed its work in January 1983. The members of the Committee were chosen to represent a broad array of back- grounds and special skills, both in the technol ogy of risk assessment and in the formulation and application of policy in this field, and brought together extensive experience in industry, government, and academic life. The Committee, with outstanding staff support, reviewed much of the published literature on risk assessment, studied the structures and operations of federal regula- tory and research agencies, analyzed the history of regu- lation of selected chemicals, and sought and received the judgments of some exceptionally knowledgeable people. We are most grateful for the assistance so generously pro- vided to us, but, of course, the responsibility for this report is entirely ours. The Committee has sought to examine and codify past experience with risk assessment and relate that experi- ence to patterns and practices. our judgments are neces- warily subjective, but we have endeavored to be impartial. In the process, we developed a disinclination for sweeping changes; we believe that more gradual, evolutionary alter- ations will result in greater improvements in the conduct and use of risk assessment. REuEL A. STALLONES Chairman

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Contents sin IN$~ODIJCTION I Tab; NA~ OF MSE ASSESSMENT Terminology, 18 Scientific and Policy Judgments in Risk Assessment, 2 8 Risk Assessment in Practice, 37 Conclusions, 48 INEl3RENCE: GUIDEL7~:S FOR }SIR ASSESSMENT Introduction and Definitions, 51 History of the Use of Guidelines, 52 Variation in the Form of Guidelines, 62 Arguments for and against the Use of Guidel Ones, 68 Conclusions, 79 III ORGANIZATION ARRANGEMENTS FOR RISK ASSESSMENT Types of Organizational Arrangements, 89 Review of Agency Procedures for Risk Assessment, 93 Proposed Changes in Organizational Arrangements for Risk Assessment, 131 Conclusions, 140 X1 1 9 17 51 86

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lo RECOMMENDATIONS Improving Risk Assessment through Procedural Changes, 151 Improving Risk Assessment throng h Uniform Inference Guidelines, 162 A Central Board on Risk Assessment Methods, 111 APPENDIX A BACKGROUND INFORMATION ON COMMITTEE MEMBERS APPENDIX B BIBLIOGRAPHY 150 177 181 APPENDIX C WORMING PAPERS 19 ~

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Risk Assessment In the Federal Government: Managing the Process

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