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 THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu 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 Na- tional Academy of Sciences, the National Academy of Engineering, and the Institute of Medi- cine. 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 pre- sented 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 cul- tures 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. “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Shaping the Future for Health The National Academy of Sciences is a private, nonprofit, self-perpetuating soci- ety of distinguished scholars engaged in scientific and engineering research, dedi- cated 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 mem- bers, sharing with the National Academy of Sciences the responsibility for advis- ing 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 profes- sions in the examination of policy matters pertaining to the health of the pub- lic. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal govern- ment 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 gov- ernment. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the Na- tional Academy of Sciences and the National Academy of Engineering in provid- ing services to the government, the public, and the scientific and engineering com- munities. 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 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 v Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with pro- cedures 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 integ- rity of the deliberative process. We wish to thank the following individu- als 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 construc- tive comments and suggestions, they were not asked to endorse the 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 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 indepen- dent examination of this report was carried out in accordance with insti- tutional procedures and that all review comments were carefully consid- ered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. vi 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 informa- tion 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 Appen- dix D of this report. Randall Huffman of the American Meat Foundation Institute and Caroline Smith DeWaal of the Center for Science in the Pub- lic Interest provided comments for the committee’s consideration. We greatly appreciate the guidance and insights offered by our liai- son 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 vii viii PREFACE 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 pro- cess; and Rita Gaskins, who provided administrative support to the project. Michael P. Doyle, Chair 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 ix