Table Of ContentEnhancing Food Safety: The Role of the Food and Drug Administration
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ENHANCING
FOOD SAFETY
THE ROLE OF THE
FOOD AND DRUG ADMINISTRATION
Committee on the Review of the Food and Drug Administration’s Role in
Ensuring Safe Food
Food and Nutrition Board
Board on Agriculture and Natural Resources
Robert B. Wallace and Maria Oria, Editors
Copyright © National Academy of Sciences. All rights reserved.
Enhancing Food Safety: The Role of the Food and Drug Administration
http://www.nap.edu/catalog/12892.html
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This study was supported by Contract No. HHSF2232008100201 between the National
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Library of Congress Cataloging-in-Publication Data
Institute of Medicine (U.S.). Committee on the Review of Food and Drug Administration’s
Role in Ensuring Safe Food.
Enhancing food safety : the role of the Food and Drug Administration / Committee on the
Review of Food and Drug Administration’s Role in Ensuring Safe Food, Food and Nutrition
Board, Board on Agriculture and Natural Resources ; Robert B. Wallace and Maria Oria,
editors.
p. ; cm.
Includes bibliographical references.
ISBN 978-0-309-15273-0 (pbk.) — ISBN 978-0-309-15274-7 (pdf)
1. Food—Safety measures—Government policy—United States. 2. United States. Food
and Drug Administration. 3. Food—Safety regulations—United States. I. Wallace, Robert
B., 1942- II. Oria, Maria. III. Title.
[DNLM: 1. United States. Food and Drug Administration. 2. Food Supply—United
States. 3. Food Contamination—prevention & control—United States. 4. Health Policy—
United States. 5. Resource Allocation—United States. 6. Risk Assessment—United States.
7. United States Government Agencies—United States. WA 695]
RA601.I39 2010
363.19’20973—dc22
2010029845
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Suggested citation: IOM (Institute of Medicine) and NRC (National Research Council). 2010.
Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC:
The National Academies Press.
Copyright © National Academy of Sciences. All rights reserved.
Enhancing Food Safety: The Role of the Food and Drug Administration
http://www.nap.edu/catalog/12892.html
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Copyright © National Academy of Sciences. All rights reserved.
Enhancing Food Safety: The Role of the Food and Drug Administration
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Copyright © National Academy of Sciences. All rights reserved.
Enhancing Food Safety: The Role of the Food and Drug Administration
http://www.nap.edu/catalog/12892.html
COMMITTEE ON THE REVIEW OF THE FOOD AND DRUG
ADMINISTRATION’S ROLE IN ENSURING SAFE FOOD
ROBERT B. WALLACE (Chair), Professor, College of Public Health,
University of Iowa, Iowa City
DOUGLAS L. ARCHER, Associate Dean for Research and Professor,
Institute of Food and Agricultural Sciences, University of Florida,
Gainesville
KEITH C. BEHNKE, Professor, Department of Grain Science and Industry,
Kansas State University, Manhattan
ANN BOSTROM, Associate Dean and Professor, Evans School of Public
Affairs, University of Washington, Seattle
ROBERT E. BRACKETT, Director and Vice President, National Center
for Food Safety and Technology, Illinois Institute of Technology,
Chicago
JULIE A. CASWELL, Department Chair and Professor, Department of
Resource Economics, University of Massachusetts, Amherst
LEWIS A. GROSSMAN, Associate Dean and Professor, Washington
College of Law, American University, Washington, DC
LEE-ANN JAYKUS, Professor, Food Science Department, North Carolina
State University, Raleigh
TIMOTHY F. JONES, State Epidemiologist, Tennessee Department of
Health, Nashville
BARBARA KOWALCYK, Director, Food Safety, Center for Foodborne
Illness Research and Prevention, Grove City, Pennsylvania
J. GLENN MORRIS, JR., Director, Emerging Pathogens Institute,
University of Florida, Gainesville
MARTHA RHODES ROBERTS, Special Assistant to the Director, Institute
of Food Agricultural Sciences, University of Florida, Gainesville
JOSEPH V. RODRICKS, Principal, ENVIRON, Arlington, Virginia
Consultants
CATHERINE W. CARNEVALE
LOUIS J. CARSON
Copyright © National Academy of Sciences. All rights reserved.
Enhancing Food Safety: The Role of the Food and Drug Administration
http://www.nap.edu/catalog/12892.html
Study Staff
MARIA ORIA, Study Director
RUTHIE S. ARIETI, Research Associate
ALICE VOROSMARTI, Research Associate
GUI LIU, Senior Program Assistant
STEPHANIE GOODWIN, Fellow
LINDA D. MEYERS, Director, Food and Nutrition Board
ROBIN SCHOEN, Director, Board on Agriculture and Natural Resources
i
Copyright © National Academy of Sciences. All rights reserved.
Enhancing Food Safety: The Role of the Food and Drug Administration
http://www.nap.edu/catalog/12892.html
Reviewers
This report has been reviewed in draft form by individuals chosen for
their diverse perspectives and technical expertise, in accordance with
procedures approved by the National Research Council’s Report
Review Committee. The purpose of this independent review is to provide
candid and critical comments that will assist the institution in making its
published report as sound as possible and to ensure that the report meets
institutional standards for objectivity, evidence, and responsiveness to the
study charge. The review comments and draft manuscript remain confiden-
tial to protect the integrity of the deliberative process. We wish to thank the
following individuals for their review of this report:
HENRY J. AARON, Senior Fellow, The Brookings Institution,
Washington, DC
JOHN BAILAR, III, Professor Emeritus, University of Chicago,
Washington, DC
KATHRYN J. BOOR, Professor, Food Science Department, Cornell
University, Ithaca, New York
BONNIE BUNTAIN, Professor, Ecosystem and Public Health
Department, University of Calgary, Alberta, Canada
J. JOSEPH CORBY, Executive Director, Association of Food and
Drug Officials, York, Pennsylvania
LESTER M. CRAWFORD, JR., Senior Counsel, Policy Directions,
Inc., Georgetown, South Carolina
CAROLINE SMITH DEWAAL, Director, Food Safety Program,
Center for Science in the Public Interest, Washington, DC
ii
Copyright © National Academy of Sciences. All rights reserved.
Enhancing Food Safety: The Role of the Food and Drug Administration
http://www.nap.edu/catalog/12892.html
iii REVIEWERS
MICHAEL P. ERIKSEN, Professor, Georgia State University, Atlanta
BOB GELLMAN, Privacy and Information Policy Consultant,
Washington, DC
DERRICK JONES, Head, Analytical Services, Survey and Research
Policy, United Kingdom Food Standards Agency, London
GULBANU KAPTAN, Researcher, Department of Social and Decision
Sciences, Carnegie Mellon University, Pittsburgh, Pennsylvania
ANNA LAMMERDING, Chief, Microbial Food Safety Risk
Assessment, Public Health Agency of Canada, Guelph, Ontario
RICHARD A. MERRILL, Professor Emeritus, University of Virginia
School of Law, Charlottesville
DALE L. MORSE, Assistant Commissioner, Office of Science,
New York State Department of Health, Albany
MARION NESTLE, Professor, Department of Nutrition, Food
Studies, and Public Health, New York University, New York
FRANK YIANNAS, Vice President, Food Safety, Walmart,
Bentonville, Arkansas
Although the reviewers listed above have provided many constructive
comments and suggestions, they were not asked to endorse the report’s con-
clusions or recommendations, nor did they see the final draft of the report
before its release. The review of this report was overseen by Enriqueta
C. Bond, President Emeritus, Burroughs Wellcome Fund, and Elena O.
Nightingale, Scholar-in-Residence, Institute of Medicine. Appointed by the
National Research Council and Institute of Medicine, they were responsible
for making certain that an independent examination of this report was
carried out in accordance with institutional procedures and that all review
comments were carefully considered. Responsibility for the final content of
this report rests entirely with the authoring committee and the institution.
Copyright © National Academy of Sciences. All rights reserved.
Enhancing Food Safety: The Role of the Food and Drug Administration
http://www.nap.edu/catalog/12892.html
Contents
Preface xi
Summary 1
Part I:
Setting the Stage for Understanding and Improving
U.S. Food and Drug Administration’s Role in the Food Safety System
1 Introduction 21
2 The Food Safety System: Context and Current Status 35
Part II:
Toward a Stronger and More Effective Food Safety System
3 Adopting a Risk-Based Decision-Making Approach to Food
Safety 75
4 Sharing the Responsibility for a Risk-Based System: Models of
Governance and Oversight 121
ix
Copyright © National Academy of Sciences. All rights reserved.
Enhancing Food Safety: The Role of the Food and Drug Administration
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x CONTENTS
Part III:
Implementation of the New Food Safety System
5 Creating an Integrated Information Infrastructure for a
Risk-Based Food Safety System 147
6 Creating a Research Infrastructure for a Risk-Based Food
Safety System 181
7 Integrating Federal, State, and Local Government Food
Safety Programs 205
8 Enhancing the Efficiency of Inspections 237
9 Improving Food Safety and Risk Communication 257
10 Modernizing Legislation to Enhance the U.S. Food Safety
System 293
11 Achieving the Vision of an Efficient Risk-Based Food Safety
System 305
Appendixes*
A Workshop Agendas 319
B Past Recommendations About the U.S. Food and Drug
Administration’s Food Safety Program 325
C Food Safety Systems in the United States and Other Countries 371
D The U.S. Food and Drug Administration’s Food Defense
Program 403
E The U.S. Food and Drug Administration and Imported
Food Safety 451
F Food Safety Research at Intramural and Extramural U.S.
Food and Drug Administration Research Centers, by Topic 493
G U.S. Food and Drug Administration Food Protection Plan 505
H Glossary 555
I Acronyms and Abbreviations 563
J Committee Member Biographical Sketches 569
* Appendixes B–G are not printed in this book. They are available on the CD in the back
of this book.
Copyright © National Academy of Sciences. All rights reserved.
