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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



Washington, D.C.

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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

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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. This study was supported by Contract No. HHSF2232008100201 between the National Academy of Sciences and the Food and Drug Administration of the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the orga- nizations or agencies that provided support for this project. 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 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, For more information about the Institute of Medicine, visit the IOM home page at: www. Copyright 2010 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. 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.

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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 Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

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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 

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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

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Reviewers T his 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

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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.

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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

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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.

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Preface T his Institute of Medicine/National Research Council report was written in response to a congressional request that the U.S. Food and Drug Administration (FDA) contract with the National Academies for a comprehensive study of gaps in public health protection provided by the food safety system in the United States. In particular, the study was to review the role of the FDA in ensuring the safety of the nation’s food supply. The committee that conducted this study hopes that the recommendations in this report will help the FDA in achieving the very important goal of protecting the health of the American public. Important functions of the FDA in regard to food safety are too numer- ous to be listed here. To name but a few, they range from resolving crises in the most expeditious and efficient manner; to predicting the next intentional food contamination episode, whether here or abroad; to communicating with and educating the public about food safety. The committee found it difficult to make recommendations for enhancing the FDA’s role in ensuring food safety without also addressing the rest of the complex system of local, state, and federal government agencies that, together with the FDA, govern food production in the United States. One main tenet of the committee’s recommendations is a call for a risk-based approach to allocating food safety resources and efforts. The committee suggests a number of enhance- ments at the FDA that would improve the efficiency of resource allocation and protection of the public health and could be initiated independently from other agencies. For other enhancements, however, improvement will not come without seamless cooperation with other agencies. For some recommendations, changes in federal law or structural reorganization are xi

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xii PREFACE essential. In essence, the committee found that the time has come to mod- ernize the nation’s food safety system so it becomes a truly integrated national program. In addition, although most of the recommendations offered are directed to the FDA, it is imperative to recognize that the FDA cannot guarantee food safety on its own, given the many other private and public parties involved in the nation’s food supply chain. Hence, some of the recommen- dations also assume the responsibility of others, including food producers and distributors and consumers. Although the committee’s deliberations were focused on improving the FDA’s functions and operations, the success of its food safety enterprise cannot be realized without the involvement of other responsible parties, and the report refers to them when appropriate. On behalf of the committee, I would like to express my great apprecia- tion to the staff at the FDA’s Office of Foods (formerly the Office of Food Protection) for the substantial time and effort they put into supporting our work. They were available to clarify the committee’s task and to educate its members about the FDA’s operations, challenges, and aspirations. In particular, this study could not have been conducted without the assistance of Dr. David Acheson, Ms. Kari Barret, and Dr. Chad Nelson, who tirelessly assisted the committee with answering numerous questions and requests for information, meetings, and conference calls. I would like to thank Michael Taylor, who served as an unpaid project consultant until June 2009, prior to his appointment as senior advisor to the FDA commissioner. On behalf of the committee, I sincerely thank the participants and speakers who con- tributed to the two workshops held to inform this study (see Appendix A) for addressing topics critical to the completion of the committee’s work. Their presentations served as essential references and resources for the committee. I would also like to gratefully acknowledge the time, effort, and skill that committee members invested in this process, with a spirit of continuous improvement and with the ultimate goal of assisting the FDA in accom- plishing its food safety mission. Their diverse backgrounds and experience ensured that all aspects of this challenging topic were addressed and that all deliberations were carried out with respect and empathy. Finally, I thank the project staff and support staff of the National Academies for their tireless dedication to the production of this report. Robert B. Wallace, Chair Committee on the Review of the Food and Drug Administration’s Role in Ensuring Safe Food