ESCHERICHIA COLI O157:H7 IN GROUND BEEF

Review of a Draft Risk Assessment

Committee on the Review of the USDA E. coli O157:H7 Farm-to-Table Process Risk Assessment

Board on Health Promotion and Disease Prevention

Food and Nutrition Board

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu



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Escherichia Coli O157:H7 In Ground Beef: Review of a Draft Risk Assessment ESCHERICHIA COLI O157:H7 IN GROUND BEEF Review of a Draft Risk Assessment Committee on the Review of the USDA E. coli O157:H7 Farm-to-Table Process Risk Assessment Board on Health Promotion and Disease Prevention Food and Nutrition Board INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Escherichia Coli O157:H7 In Ground Beef: Review of a Draft Risk Assessment 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. Support for this project was provided by the US Department of Agriculture. The views presented in this report are those of the Institute of Medicine Committee on the Review of the USDA E. coli O157:H7 Farm-to-Table Process Risk Assessment and are not necessarily those of the funding agencies. International Standard Book No. 0-309-08627-2 Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, N.W., Box 285, Washington, D.C. 20055; call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2002 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 logo-type by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Escherichia Coli O157:H7 In Ground Beef: Review of a Draft Risk Assessment “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Shaping the Future for Health

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Escherichia Coli O157:H7 In Ground Beef: Review of a Draft Risk Assessment THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine 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. Wm. 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. 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council www.national-academies.org

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Escherichia Coli O157:H7 In Ground Beef: Review of a Draft Risk Assessment COMMITTEE ON THE REVIEW OF THE USDA E. COLI O157:H7 FARM-TO-TABLE PROCESS RISK ASSESSMENT Michael P. Doyle, PhD (Chair), Regents Professor of Food Microbiology and Director of the Center for Food Safety, University of Georgia, Griffin, Georgia Scott Ferson, PhD, Senior Scientist and Vice President, Applied Biomathematics, Setauket, New York Dale D. Hancock, DVM, MS, PhD, Professor and Epidemiologist, Field Disease Investigation Unit, Department of Veterinary Clinical Sciences, Washington State University, Pullman, Washington Myron M. Levine, MD, DTPH, Professor and Director, University of Maryland School of Medicine, Center for Vaccine Development, Baltimore, Maryland Greg Paoli, MASc, President, Decisionalysis Risk Consultants, Inc., Ottawa, Ontario Barbara J. Peterson, PhD, MPH, Principal/Practice Director, Food and Chemicals Practice, Exponent, Washington, DC John N. Sofos, PhD, Professor, Department of Animal Sciences, Colorado State University, Fort Collins, Colorado Susan S. Sumner, PhD, Professor, Department Head and Extension Project Leader, Department of Food Science and Technology, Virginia Polytechnic Institute and State University, Blacksburg, Virginia Liaison from the Board on Health Promotion and Disease Prevention Hugh Tilson, MD, DrPH, Clinical Professor of Epidemiology and Health Policy and Senior Adviser to the Dean, School of Public Health, University of North Carolina at Chapel Hill Staff David A. Butler, PhD, Study Director Allison Yates, PhD, RD, Director, Food and Nutrition Board Rose Marie Martinez, ScD, Director, Board on Health Promotion and Disease Prevention Jennifer A. Cohen, Research Associate Anna Staton, MPA, Research Assistant Elizabeth Albrigo, Project Assistant Rita Gaskins, Division Assistant Jim Banihashemi, JD, Financial Associate Melissa French, Financial Associate Norman Grossblatt, Senior Editor Staff Consultant Ricardo Molins, PhD, Senior Staff Officer

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Escherichia Coli O157:H7 In Ground Beef: Review of a Draft Risk Assessment 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 NRC’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 confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Mindy Brashears, PhD, Texas Tech University P. Michael Davidson, PhD, University of Tennessee Colin O. Gill, PhD, Agriculture and Agri-Food Canada Jimmy T. Keeton, PhD, Texas A&M University Jørgen Schlundt, DVM, PhD, World Health Organization 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 this report was overseen by Stephen L. Taylor, PhD, University of Nebraska and Ronald W. Estabrook, PhD, University of Texas Southwestern Medical Center at Dallas. Appointed by the NRC, 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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Escherichia Coli O157:H7 In Ground Beef: Review of a Draft Risk Assessment Preface The efforts of the Committee on the Review of the USDA E. coli O157:H7 Farm-to-Table Process Risk Assessment were supported by the work and dedication of the project staff and numerous other individuals who shared their thoughts and expertise with the committee. We could not have completed our task satisfactorily without the substantial help of the these individuals. We are particularly indebted to Wayne Schlosser and Eric Ebel of the US Department of Agriculture (USDA), who provided detailed information on the draft risk assessment and answered the committee’s many questions. Special thanks are also extended to I. Kaye Wachsmuth, Karen Hulebak, Carol Maczka, and Kathleen Orloski of USDA, and Anna Lammerding of Health Canada, for their expert advice and assistance. Edmund Crouch of Cambridge Environmental Inc. contributed a detailed examination of the draft model spreadsheet that is reproduced as Appendix D of this report. Randall Huffman of the American Meat Foundation Institute and Caroline Smith DeWaal of the Center for Science in the Public Interest provided comments for the committee’s consideration. We greatly appreciate the guidance and insights offered by our liaison from IOM’s Board on Health Promotion and Disease Prevention, Hugh Tilson. Food and Nutrition Board (FNB) Chair Cutberto Garza, and FNB member Robert Smith provided input on report drafts. David A. Butler, who served as the study director for this project, worked in concert with Ricardo Molins of FNB to produce this report. The committee would also like to acknowledge the excellent work of IOM staff members Jennifer Cohen, Anna Staton, and Elizabeth Albrigo. Thanks are

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Escherichia Coli O157:H7 In Ground Beef: Review of a Draft Risk Assessment also extended to Melissa French and Jim Banihashemi, who handled the finances for the project; Norman Grossblatt who provided editorial input; William McLeod, who conducted database searches; Jennifer Otten, who supervised the report through the editorial and publication phases; Bronwyn Schrecker, who shepherded the report through the review process; and Rita Gaskins, who provided administrative support to the project. Michael P. Doyle, Chair

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Escherichia Coli O157:H7 In Ground Beef: Review of a Draft Risk Assessment Contents     EXECUTIVE SUMMARY   1     Background,   1     Organization and Framework,   3     Comments Regarding the Draft Risk Assessment,   4 1   SUMMARY OF THE FOOD SAFETY AND INSPECTION SERVICE DRAFT RISK ASSESSMENT   13     Production Module,   14     Slaughter Module,   17     Preparation Module,   22     Hazard Characterization Module,   25     Risk Characterization Module,   26 2   PRODUCTION MODULE   27     Fecal Prevalence as the Sole Output of the Production Module,   28     Defensibility of Prevalence Estimations for Cull Cows and Feedlot Animals,   30 3   SLAUGHTER MODULE   41     Lack of Data and Difficulties Associated with Data Collection,   42     Sources of Contamination and Cross Contamination During Slaughter and Fabrication,   44     Levels and Extent of Surface-Area Contamination,   50     Terminology Concerns,   55     Other Observations,   56     Summary Remarks,   58

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Escherichia Coli O157:H7 In Ground Beef: Review of a Draft Risk Assessment 4   PREPARATION MODULE   62     Cross Contamination,   62     Modeling in the Preparation Module,   65 5   HAZARD CHARACTERIZATION   71     Review of the Hazard Characterization Chapter,   72     Summary Remarks,   84 6   RISK CHARACTERIZATION   89     Definition of Key Terms,   89     Risk of Illness from E. Coli O157:H7,   91     Population Risk by Season, Age, and Location,   94     Sensitivity Analysis,   95     Conclusions,   95     General Comments,   96 7   MODELING APPROACH AND IMPLEMENTATION   97     Description of the Overall Modeling Approach,   98     Description of Model-Updating (Anchoring) Algorithms,   103     Model Validation,   108     Modeling Issues in Hazard Characterization,   109     Software Implementation,   115     Justification of Modeling Assumptions,   121     Overall Model Uncertainty and Reliability,   126     APPENDIXES     A   AGENDAS OF PUBLIC MEETINGS HELD BY THE COMMITEE ON THE REVIEW OF THE USDA E. COLI O157:H7 FARM–TO–TABLE RISK ASSESSMENT   135 B   ADDITIONAL COMMENTS   137 C   COMMITTEE AND STAFF BIOGRAPHIES   141 D   E. COLI ASSESSMENT: SOME COMMENTS BY EDMUND CROUCH, PhD, CAMBRIDGE ENVIRONMENTAL INC.   147