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Food Safety Policy, Science, and Risk Assessment: Strengthening the Connection

Workshop Proceedings

Food Forum

Food and Nutrition Board

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.



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Page i Food Safety Policy, Science, and Risk Assessment: Strengthening the Connection Workshop Proceedings Food Forum Food and Nutrition Board INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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Page ii NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 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. Support for this project was provided by U.S. Department of Health and Human Services Food and Drug Administration, U.S Department of Agriculture Food Safety and Inspection Service, U.S. Department of Commerce National Marine Fisheries Service, Bestfoods, Frito-Lay, Inc., General Mills, Kellogg Company, Kraft Foods, Inc., Lipton, Monsanto Company, Nabisco, Inc., Nestlé USA, Proctor & Gamble, and Ross Products. The opinions or conclusions expressed herein are those of the workshop participants and do not necessarily reflect those of the funders. International Standard Book Number 0-309-07323-5 This report is available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055; call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP on-line bookstore at www.nap.edu . For more information about the Institute of Medicine or the Food and Nutrition Board, visit the IOM home page at www.iom.edu. Copyright 2001 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Page iii “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe ~ enlarge ~ INSTITUTE OF MEDICINE Shaping the Future for Health

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Page iv THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council 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 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 achievements of engineers. Dr. William 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 examination 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. 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 scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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Page v FOOD FORUM FERGUS M. CLYDESDALE (Chair), University of Massachusetts, Amherst LARRY R. BEUCHAT, University of Georgia, Griffin NANCY M. CHILDS, Saint Joseph's University, Philadelphia, Pennsylvania MARSHA N. COHEN, Hastings College of the Law, University of California, San Francisco ROBERT DROTMAN, Frito-Lay, Inc., Plano, Texas WILLIAM C. FRANKE, Lipton, Englewood Cliffs, New Jersey ARTHUR L. HECKER, Ross Products Division, Abbott Laboratories, Columbus, Ohio JERRY HJELLE, Monsanto Company, St. Louis, Missouri WILLIAM KELLY JONES, Nabisco Foods Group, East Hanover, New Jersey FRANKLIN M. LOEW, Becker College, Worcester, Massachusetts JOANNE R. LUPTON, Texas A& M University, College Station EILEEN MADDEN, Nestlé USA, Purchase, New York STEPHEN H. McNAMARA, Hyman, Phelps & McNamara, Washington, D.C. DIANI SANTUCCI, Bestfoods, Englewood Cliffs, New Jersey SHERI M. SCHELLHAASS, General Mills, Minneapolis, Minnesota TRACIE SHEEHAN, Kellogg Company, Battle Creek, Michigan MARK SILBERGELD, Consumers Union, Washington, D.C. ROBERT E. SMITH, R.E. Smith Consultants, Inc., Newport, Vermont BRUCE R. STILLINGS, Food and Agriculture Consultants, Inc., Falmouth, Maine SUSAN SUMNER, Virginia Polytechnic Institute of Technology, Blacksburg RONALD TRIANI, Kraft Foods, Glenview, Illinois KEITH TRIEBWASSER, Procter & Gamble, Cincinnati, Ohio Ex-Offico Members E. SPENCER GARRETT, National Marine Fisheries Service, Pascagoula, Mississippi JOZEF KOKINI, Rutgers University, New Brunswick, New Jersey MARC Le MAGUER, Health Canada, Ottawa, Ontario JOSEPH A. LEVITT, Food and Drug Administration, Washington, D.C. DONNA V. PORTER, Library of Congress, Washington, D.C. SUSAN H. WAYLAND, U.S. Environmental Protection Agency, Washington, D.C. CATHERINE WOTEKI, U.S. Department of Agriculture, Washington, D.C. Forum Staff SANDRA SCHLICKER, Director GERALDINE KENNEDO, Project Assistant JENNIFER OTTEN, Communications Specialist (July 1999–February 2000)

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Page vi FOOD AND NUTRITION BOARD CUTBERTO GARZA (Chair), Cornell University, Ithaca, New York ALFRED H. MERRILL, Jr. (Vice Chair), Emory University, Atlanta, Georgia ROBERT M. RUSSELL (Vice Chair), Tufts University, Boston, Massachusetts VIRGINIA A. STALLINGS (Vice Chair), The Children's Hospital of Philadelphia, Pennsylvania LARRY R. BEUCHAT, University of Georgia, Griffin BENJAMIN CABALLERO, Johns Hopkins School of Hygiene and Public Health, Baltimore, Maryland FERGUS M. CLYDESDALE, University of Massachusetts, Amherst ROBERT J. COUSINS, University of Florida, Gainesville SCOTT M. GRUNDY, University of Texas Southwestern Medical Center, Dallas SHIRIKI KUMANUIKA, University of Pennsylvania, Philadelphia LYNN PARKER, Food Research and Action Center, Washington, DC ROSS L. PRENTICE, Fred Hutchinson Cancer Research Center, Seattle, Washington A. CATHARINE ROSS, The Pennsylvania State University, University Park ROBERT E. SMITH, R.E. Smith Consulting, Inc., Newport, Vermont STEVE L. TAYLOR, University of Nebraska, Lincoln Staff ALLISON A. YATES, Director GAIL E. SPEARS, Administrative Assistant GARY WALKER, Financial Associate

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Page vii Contents 1     INTRODUCTION 1 2     SCIENCE AS THE BASIS FOR FOOD SAFETY POLICY 3     Good Science: Critical to Regulatory Decision-Making, Jane E. Henney, 3     Statutory Authority: Differences Among Agencies, Catherine E. Woteki, 5     Role of the Joint Institute for Food Safety Research, William F. Raub, 6 3     DEFINING INCIDENTS LEADING TO CHANGES IN FOOD SAFETY POLICY 8     Vegetable Sprouts, Robert L. Buchanan, 8     Meat and Poultry Hazard Analysis Critical Control Points, Thomas J. Billy, 10     Escherichia coli O157:H7 and Listeria monocytogenes, Michael P. Doyle, 11     1996 Food Quality Protection Act, Joyce A. Nettleton, 15 4     OTHER FACTORS INFLUENCING THE DEVELOPMENT OF FOOD SAFETY POLICY 18     International Considerations, Fritz Käferstein, 18     Regulatory Considerations, Morris Potter, 19     Business Considerations, Dane Bernard, 20     Consumer Considerations, Edward Groth III, 22     Political Considerations, Eric Juzenas, 23 5     USING SCIENCE-BASED RISK ASSESSMENT TO DEVELOP FOOD SAFETY POLICY 25     Historical Perspective of Risk Assessment and Steps in the Process, Joseph V. Rodricks, 25     Promise and Pitfalls of Risk Assessment, George M. Gray, 27     Using Risk Assessment to Establish Food Safety Policy: Salmonella enteriditis, Robert L. Buchanan, 28     Risk Communication: Defining a Tolerable Level of Risk, Susan L. Santos, 30     Joint FAO/WHO Consultation on Risk Assessment of Microbiological Hazards in Foods, Lester M. Crawford, 31

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Page viii 6     OVERVIEW 33     Where Do We Go from Here?, M. Jaye Nagle, 33 APPENDIXES A     Workshop Agenda, 35 B     Workshop Participants, 38