Review of the Methodology Proposed by the Food Safety and Inspection Service for Risk-Based Surveillance of In-Commerce Activities

A Letter Report

Committee for the Review of the Methodology Proposed by the Food Safety and Inspection Service (FSIS) for Risk-Based Regulation of In-Commerce Activities

Board on Agriculture and Natural Resources

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu



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Review of the Methodology Proposed by the Food Safety and Inspection Service for Risk-Based Surveillance of In-Commerce Activities A Letter Report Committee for the Review of the Methodology Proposed by the Food Safety and Inspection Service (FSIS) for Risk-Based Regulation of In-Commerce Activities Board on Agriculture and Natural Resources Division on Earth and Life Studies

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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 a grant from U.S. Department of Agriculture, Food Safety Inspection Service under Contract No. AG-3A94-D-08-0257. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. The report is available online from the National Academies Press at http://www.nap.edu. Copyright 2009 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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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 Academy 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 engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest 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. Harvey V. Fineberg 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE TO REVIEW THE METHODOLOGY PROPOSED BY THE FOOD SAFETY AND INSPECTION SERVICE (FSIS) FOR RISK-BASED REGULATION OF IN-COMMERCE ACTIVITIES JOHN N. SOFOS (Chair), Colorado State University, Fort Collins LEANN B. CHUBOFF, National Restaurant Association Solutions, Chicago, IL WILLIAM H. DUMOUCHEL, Phase Forward, Inc., Waltham, MA WILLIAM H. SPERBER, Cargill, Inc., Minnetonka, MN KATHERINE M. J. SWANSON, Ecolab, Inc., Eagan, MN EWEN C. D. TODD, Michigan State University, East Lansing CHRISTOPHER A. WALDROP, Consumer Federation of America, Washington, DC RICHARD A. WILLIAMS, George Mason University, Arlington, VA Staff AUSTIN J. LEWIS, Senior Program Officer RUTHIE S. ARIETI, Research Associate ROBIN A. SCHOEN, Director, Board on Agriculture and Natural Resources NORMAN GROSSBLATT, Senior Editor v

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BOARD ON AGRICULTURE AND NATURAL RESOURCES W. REG GOMES, Chair, University of California, (Emeritus), Oakland ROGER N. BEACHY, Donald Danforth Plant Science Center, St. Louis, Missouri H.H. CHENG, University of Minnesota (Emeritus), St. Paul DANIEL M. DOOLEY, University of California, Oakland JOAN H. EISEMANN, North Carolina State University, Raleigh KIRK C. KLASING, University of California, Davis VICTOR L. LECHTENBERG, Purdue University, West Lafayette, Indiana ROBERT PAARLBERG, Wellesley College, Watertown, Massachusetts KEITH PITTS, Marrone Organic Innovations, Davis, California HAL SALWASSER, Oregon State University, Corvallis PEDRO A. SANCHEZ, The Earth Institute, Columbia University, Palisades, New York NORMAN R. SCOTT, Cornell University, Ithaca, New York Staff ROBIN A. SCHOEN, Director KAREN L. IMHOF, Administrative Assistant AUSTIN J. LEWIS, Senior Program Officer EVONNE P.Y. TANG, Senior Program Officer CAMILLA YANDOC ABLES, Associate Program Officer KARA N. LANEY, Associate Program Officer PEGGY TSAI, Associate Program Officer RUTH S. ARIETI, Research Associate JANET M. MULLIGAN, Research Associate KAMWETI MUTU, Research Associate ERIN P. MULCAHY, Senior Program Assistant vi

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Acknowledgments This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council Report Review Committee. The purpose of the 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 of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following for their review of the report: Gary Ades, G&L Consulting Group, LLC, Bentonville, AR Marion F. Aller, Florida Department of Agriculture and Consumer Services, Tallahassee John C. Bailar, III, The University of Chicago (emeritus) Larry R. Beuchat, University of Georgia, Griffin Sandra B. Eskin, Georgetown Health Policy Institute, Washington, DC Barbara Kowalcyk, Center for Foodborne Illness Research & Prevention, Grove City, PA Robert L. Scharff, The Ohio State University, Columbus Robert Bruce Tompkin, ConAgra Foods, Inc., LaGrange, IL (retired) Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of the report was overseen by Johanna T. Dwyer, the National Institutes of Health. Appointed by the National Academy of Sciences, she was responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests entirely with the author committee and the institution. vii

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