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OCR for page R1
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,
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(800) 624-6242
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(in the Washington metropolitan area), or visit the NAP on-line bookstore at
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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
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