Review of the Methodology Proposed by the Food Safety and Inspection Service for Followup Surveillance of In-Commerce Businesses

A Letter Report

Committee for the Review of the Methodology Proposed by the Food Safety and Inspection Service (FSIS) for Followup Surveillance of In-Commerce Businesses

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 Followup Surveillance of In-Commerce Businesses A Letter Report Committee for the Review of the Methodology Proposed by the Food Safety and Inspection Service (FSIS) for Followup Surveillance of In-Commerce Businesses 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 the U.S. Department of Agriculture, Food Safety and Inspection Service under Contract No. AG-3A94-D-08-0262. 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 on line 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 FOR THE REVIEW OF THE METHODOLOGY PROPOSED BY THE FOOD SAFETY AND INSPECTION SERVICE (FSIS) FOR FOLLOWUP SURVEILLANCE OF IN-COMMERCE BUSINESSES JOHN N. SOFOS (Chair), Colorado State University, Fort Collins, CO LEANN B. CHUBOFF, Food Marketing Institute, Arlington, VA MARGARET D. HARDIN, Texas A&M University, College Station, TX JULIANA M. RUZANTE, University of Maryland, College Park, MD WILLIAM H. SPERBER, Cargill, Inc., Minnetonka, MN EWEN C. D. TODD, Michigan State University, East Lansing, MI 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 NORMAN R. SCOTT (Chair), Cornell University, Ithaca, NY PEGGY F. BARLETT, Emory University, Atlanta, GA ROGER N. BEACHY, Donald Danforth Plant Science Center, St. Louis, MO HAROLD L. BERGMAN, University of Wyoming, Laramie, WY RICHARD A. DIXON, Samuel Roberts Noble Foundation, Ardmore, OK DANIEL M. DOOLEY, University of California, Oakland, CA JOAN H. EISEMANN, North Carolina State University, Raleigh, NC GARY F. HARTNELL, Monsanto Company, St. Louis, MO GENE HUGOSON, Minnesota Department of Agriculture, St. Paul, MN KIRK C. KLASING, University of California, Davis, CA VICTOR L. LECHTENBERG, Purdue University, West Lafayette, IN PHILIP E. NELSON, Purdue University, West Lafayette, IN ROBERT PAARLBERG, Wellesley College, Watertown, MA KEITH PITTS, Marrone Organic Innovations, Davis, CA CHARLES W. RICE, Kansas State University, Manhattan, KS HAL SALWASSER, Oregon State University, Corvallis, OR PEDRO A. SANCHEZ, The Earth Institute, Columbia University, Palisades, NY ROGER A. SEDJO, Resources for the Future, Washington, D.C. KATHLEEN SEGERSON, University of Connecticut, Storrs, CT MERCEDES VÁZQUEZ-AÑÓN, Novus International, Inc., St. Charles, MO Staff ROBIN A. SCHOEN, Director KAREN L. IMHOF, Administrative Assistant AUSTIN J. LEWIS, Senior Program Officer EVONNE P.Y. TANG, Senior Program Officer PEGGY TSAI, Program Officer CAMILLA YANDOC ABLES, Associate Program Officer KARA N. LANEY, Associate Program Officer RUTHIE 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: Marion F. Aller, Florida Department of Agriculture and Consumer Services, Tallahassee, FL James Dickson, Iowa State University, Ames, IA William H. DuMouchel, Phase Forward, Inc., Tucson, AZ John Guzewich, Center for Food Safety and Applied Nutrition, US Food & Drug Administration, College Park, MD Larry Kohl, Food Marketing Institute, Arlington, VA Karl H. Norris, Agricultural Research Service, US Department of Agriculture, Beltsville, MD (retired) Jeff Schneider, The Robotics Institute, Carnegie Mellon University, Pittsburgh, PA Katherine M. J. Swanson, Ecolab, Inc., Eagan, MN 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 Michael P. Doyle, University of Georgia, coordinator, appointed by the Division of Earth and Life Studies, and Stephen E. Fienberg, Carnegie Mellon University, monitor, appointed by the NRC’s Report Review Committee. The coordinator and monitor were 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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BOARD ON AGRICULTURE AND NATURAL RESOURCES 500 Fifth Street, NW Washington, DC 20001 Phone: 202 334 3062 Fax: 202 334 1978 E-mail: banr@nas.edu www.dels.nas.edu/banr September 30, 2009 Mr. Matthew Gonzales Program Analyst Program Evaluation and Improvement Staff USDA/FSIS/OPEER 1400 Independence Ave., SW Room 3833 South Building Washington, DC 20250-3700 Dear Mr. Gonzales: At the request of the Food Safety and Inspection Service (FSIS), the National Academies’ Division on Earth and Life Studies established the ad hoc Committee for the Review of the Methodology Proposed by the Food Safety and Inspection Service for Followup Surveillance of In-Commerce Businesses. The committee’s charge was to review and comment on the assumptions, risk factors, and methodology FSIS proposes to use to prioritize followup surveillance at in-commerce business with prior surveillance history. The committee held one in-person meeting and two conference calls. During the first meeting, FSIS staff presented their proposed approach and answered questions raised by committee members. There were also presentations by representatives of the Association of Food and Drug Officials, the Food and Drug Administration, and the Food Marketing Institute. The remainder of the committee’s time was spent preparing the report and responding to comments of external reviewers. This letter report contains the committee’s findings and recommendations. The committee commends FSIS for continuing its efforts to develop in-commerce surveillance activities, based on sound scientific principles, for the protection of public health. Sincerely, John N. Sofos, Chair Committee for the Review of the Methodology Proposed by the Food Safety and Inspection Service for Followup Surveillance of In-Commerce Businesses ix

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