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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food Food and Nutrition Board Board on Agriculture and Natural Resources INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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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 Insti- tute 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 U.S. Department of Health and Human Services, Food and Drug Administration, under contract number 223-01-2460, Task Order 6, and the U.S. Department of Agriculture, Food Safety and Inspection Service, under contract number FSIS-27-B-01. The views presented in this report are those of the Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food and are not necessarily those of the funding agencies. Library of Congress Cataloging-in-Publication Data Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food. Scientific criteria to ensure safe food / Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, Food and Nutrition Board, Board on Agriculture and Natural Resources. p. ; cm. Includes bibliographical references. ISBN 0-309-08928-X (hardcover), ISBN 0-309-50920-3 (PDF) 1. Food Safety measures 2. Food adulteration andinspection. [DNLM: 1. Food Contamination prevention & control. 2. Food Microbiology. 3. Food Supply standards. WA 701 S416 2003] I. Title. TX531.C586 2003 363.19'26 dc22 2003015501 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, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2003 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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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. nationa l-academies.org

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THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, aniMedirine 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 ~ 863, 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 Engineenng 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 ~ 970 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 sentences 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-academ ies~org

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COMMITTEE ON THE REVIEW OF THE USE OF SCIENTIFIC CRITERIA AND PERFORMANCE STANDARDS FOR SAFE FOOD CLAUDE EARL FOX (Co-chair), Urban Health Institute, Johns Hopkins University, Baltimore, Maryland CAMERON HACKNEY (Co-chair), Davis College of Agriculture, Forestry and Consumer Sciences, West Virginia University, Morgantown KATHRYN ,1. BOOR, Department of Food Science, Cornell University, Ithaca, New York ELIZABETH BOYLE, Department of Animal Sciences and Industry, Kansas State University, Manhattan MARSHA N. COHEN, Hastings College of the Law, University of California, San Francisco ,IAMES S. DICKSON, Department of Microbiology, Iowa State University, Ames DARRELL W. DONAHUE, Department of Chemical and Biological Engineering, University of Maine, Orono JEFFREY M. FARBER, Bureau of Microbial Hazards, Health Products and Food Branch, Food Directorate, Health Canada, Ottawa, Ontario ROBERT GRAVANI, Department of Food Science, Cornell University, Ithaca, New York RICHARD L. GUERRANT, Division of Geographic and International Medicine, Health Sciences Center, University of Virginia, Charlottesville NEAL H. HOOKER, Department of Agricultural, Environmental and Development Economics, The Ohio State University, Columbus JOHN A. MARCY, Center of Excellence for Poultry Science, University of Arkansas, Fayetteville DONALD W. SCHAFFNER, Department of Food Science, Rutgers University, New Brunswick, New Jersey DONN R. WARD, Department of Food Science, North Carolina State University, Raleigh Consultants THOMAS P. GRUMBLY, Keystone Center, Keystone, Colorado I. GLENN MORRIS, JR., Department of Epidemiology and Preventative Medicine, University of Maryland School of Medicine, Baltimore ROBERT V. TAUXE, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia v

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SUBCOMMITTEE ON MEAT AND POULTRY ,IAMES S. DICKSON (Chair), Department of Microbiology, Iowa State University, Ames ELIZABETH BOYLE, Department of Animal Sciences and Industry, Kansas State University, Manhattan NEAL H. HOOKER, Department of Agricultural, Environmental and Development Economics, The Ohio State University, Columbus JOHN A. MARCY, Center of Excellence for Poultry Science, University of Arkansas, Fayetteville JIM E. RIVIERE, Center for Chemical Toxicology Research and Pharmacokinetics, College of Veterinary Medicine, North Carolina State University, Raleigh JOHN G. SURAK, Department of Food Science and Nutrition, Clemson University, Clemson, South Carolina TERRI WENGER, Trade and Consumer Protection, Wisconsin Department of Agriculture, Madison SUBCOMMITTEE ON PRODUCE AND RELATED PRODUCTS, SEAFOOD, AND DAIRY PRODUCTS ROBERT GRAVANI (Chair), Department of Food Science, Cornell University, Ithaca, New York KATHRYN ,1. BOOR, Department of Food Science, Cornell University, Ithaca, New York DARRELL DONAHUE, Department of Chemical and Biological Engineering, University of Maine, Orono LINDA ,1. HARRIS, Department of Food Science and Technology, University of California-Davis CRAIG HEDBERG, Division of Environmental and Occupational Health. University of Minnesota, Minneapolis W. STEVEN OTWELL, Department of Food Science and Human Nutrition, University of Florida, Gainesville DONN R. WARD, Department of Food Science, North Carolina State University, Raleigh vim

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Stay RICARDO MOLINS, Study Director MARIA ORIA, Program Officer TAZIMA A. DAVIS, Research Assistant SANAIT TESFAGIORGIS, Senior Prolect Assistant GAIL E. SPEARS, Staff Editor GARY WALKER, Financial Associate - . . vat

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FOOD AND NUTRITION BOARD ROBERT M. RUSSELL (Vice-chair), U.S. Department of Agriculture Jean Mayer Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts LARRY R. BEUCHAT, Center for Food Safety, University of Georgia, Griffin BENJAMIN CABALLERO, Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland SHIRIKI KUMANYIKA, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia LYNN PARKER, Child Nutrition Programs and Nutrition Policy, Food Research and Action Center, Washington, D.C. A. CATHARINE ROSS, Nutrition Department, Pennsylvania State University, University Park BARBARA O. SCHNEEMAN, Department of Nutrition, University of California, Davis STEVE L. TAYLOR, Department of Food Science and Technology and Food Processing Center, University of Nebraska-Lincoln CATHERINE E. WOTEKI, Department of Food Science and Human Nutrition, Iowa State University, Ames BARRY L. ZOUMAS, Department of Agricultural Economics and Rural Sociology, Pennsylvania State University, University Park Staff ALLISON A. YATES, Director LINDA D. MEYERS, Deputy Director GAIL E. SPEARS, Staff Editor GERALDINE KENNEDO, Administrative Assistant GARY WALKER, Financial Associate . . . vail

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BOARD ON AGRICULTURE AND NATURAL RESOURCES MAY R. BERENBAUM (Chair), Entomology Department, University of Illinois at Urbana-Champaign SANDRA BARTHOLMEY, Crystal Lake, Illinois DEBORAH BLUM, School of Journalism and Mass Communication, University of Wisconsin, Madison H.H. CHENG, Department of Soil, Water and Climate, University of Minnesota, St. Paul BARBARA P. GLENN, Federation of Animal Science Societies, Bethesda, Maryland LINDA F. GOLODNER, National Consumers League, Washington, D.C. W.R. GOMES, Department of Agriculture and Natural Resources, University of California, Oakland PERRY R. HAGENSTEIN, Institute for Forest Analysis, Planning, and Policy, Wayland, Massachusetts JANET C. KING, U.S. Department of Agriculture Western Human Nutrition Research Center, University of California, Davis DAVID P. LOUCKS, Department of Civil and Environmental Engineering, Cornell University, Ithaca, New York WHITNEY MACMILLAN, Minneapolis, Minnesota TERRY MEDLEY, Global Regulatory Affairs, DuPont Agriculture and Nutrition, Wilmington, Delaware OLE NIELSEN, Department of Ecosystem Health, Ontario Veterinary College, Spruce Grove, Alberta ALICE N. PELL, Department of Animal Science, Cornell University, Ithaca, New York BOBBY PHILLS, Land Grant Programs, Florida A&M University, Tallahassee SHARON S. QUISENBERRY, College of Agriculture, Montana State University, Bozeman SONYA SALAMON, Department of Community and Rural Studies, University of Illinois at Urbana-Champaign G. EDWARD SCHUH, Humphrey Institute of Public Affairs, University of Minnesota, Minneapolis BRIAN ,1. STASKAWICZ, Department of Plant and Microbial Biology, University of California, Berkeley JACK WARD THOMAS, School of Forestry, University of Montana, Missoula ,IAMES H. TUMLINSON III, Agricultural Research Service, U.S. Department of Agriculture, Gainesville, Florida B.L. TURNER II, Graduate School of Geography, Clark University, Worcester, Massachusetts Six

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Staff CHARLOTTE KIRK BAER, Director DONNA LEE ,IAMEISON, Administrative Assistant

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Preface Protecting public health by promoting food safety has long been recognized as a state and federal responsibility. It has evolved through a series of legislative acts that responded to the fact that a significant proportion of human illness and deaths often have their genesis in the food supply. The U.S. Congress, concerned about recurrent controversy regarding the scientific basis of food safety criteria in regulating meat and poultry processing, commissioned the National Academies, through the Food Safety Inspection Service of the U.S. Department of Agriculture (USDA), to conduct the study that has resulted in this report. The study was to emphasize, but not be limited to, microbiological criteria currently in use in the meat and poultry industries. Recognizing that the issues surrounding food safety criteria are common to all sectors of the food industry, the National Academies invited the Food and Drug Administration (FDA) to cosponsor the study. As a result, the scope of the study includes food safety criteria currently in use in the processing of seafood, produce and related products, and dairy products. An ad hoc committee appointed by the National Academies to examine the relevant general issues of interest to the USDA and FDA was charged with developing two reports, assisted by two subcommittees, one on meat and poultry and a second one on seafood, produce and related products, and dairy products. However, it was later agreed with the sponsors than only one report would be produced. The committee was asked to develop definitions for the terms "performance standard" and "criteria" and to (1) evaluate the scientific basis for existing criteria, particularly microbiological performance standards, applicable to the selected food groups, and the extent to which these standards are appropriate means of ensuring the safety of such foods x~

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xt! PREFACE within a Hazard Analysis and Critical Control Point (HACCP)-based system; (2) define the science-based process to establish food safety criteria and recom- mend guidelines as to what data are adequate and appropriate for use in develop- ing new, or modifying existing, criteria; (3) examine whether current criteria accomplish what they purport to accomplish and the need to relate science-based criteria to public health objectives; (4) review the need for performance standards as measures of process control and the way such criteria are used under HACCP; and (5) recommend changes for improvement. During its deliberations, the com- mittee and subcommittees heard from consumer, industry, and government repre- sentatives, and from interested individuals. The National Academies appointed a committee comprised of 14 members with expertise and background in HACCP, public health, epidemiology of food- borne diseases, food regulatory processes, law, consumer perspective, food science, food microbiology, statistics of process control, process engineering, risk assess- ment of food contaminants, and microbial growth modeling. The composition and size of this committee changed after the first meeting; representation from the public health and regulatory areas was augmented. Several committee members participated also in one of the two subcommittees, each composed of seven members with expertise in processing of the food groups under study. The sub- committee chairs worked closely with the committee co-chairs and, in a real sense, the overall committee had four co-chairs. Despite the diversity of disci- plines and backgrounds represented, very lively and often intense discussions gave way to committee consensus quickly and readily. To supplement its expertise and to gather information on specific issues relevant to its charge, the committee conducted a workshop and held three open sessions as part of three of the committee's six meetings. The committee is grateful to the participants in the expert panel, Jorgen Schlundt, World Health Organization; Robert Tauxe, Centers for Disease Control and Prevention; Carol Tucker Foreman, Consumer Federation of America; Don L. Zink; Kaye Wachsmuth, Food Safety Inspection Service (retired); Michael Taylor, Resources for the Future; and Frank Busta, University of Minnesota. The committee' s appreciation is also extended to the USDA and FDA staff that contributed information, par- ticularly Robert Buchanan (FDA), Philip Derfler (USDA), Daniel Englejohn (USDA), Elise Golan (USDA), and William Garthright (FDA). In addition, the committee is grateful to Bruce Tompkin, International Commission on Microbio- logical Specifications for Foods, for his presentation to the committee. Special recognition is extended to the representatives of consumer groups, trade organi- zations, and the general public who contributed valuable information or views that greatly enhanced the committee's knowledge and perspective on the issues under consideration. The Executive Summary presents the recommendations and the principal findings of the committee, as well as some of the main definitions developed or adopted by the committee in response to the charge. Chapter 1 describes the

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PREFACE . . . Xti! historical development of food safety regulatory approaches in the United States; Chapter 2 highlights the importance of foodborne disease surveillance and moni- toring of microbial contaminants of food, both from a public health standpoint and as measures of the effectiveness of food safety criteria; Chapter 3 describes a science-based strategy for developing food safety criteria, including performance standards, and the procedures for obtaining the best data to support this process. It also discusses various food safety tools available to the regulatory agencies in developing and implementing science-based food safety criteria, including con- cepts for addressing the magnitude of the risk of foodborne illness and identify- ing factors that control that risk, a novel approach to relate performance standards to public health objectives, and the economics of food safety criteria, and pro- vides recommendations for improvement. The discussion of each "tool" in the report is limited by design to that which is relevant to food safety, recognizing that some, such as statistical process control and the economic aspects of criteria, not only may be foreign to many food processors and food safety regulators, but are also methodologies that only recently are being brought into play in food safety. The subcommittees, in turn, contributed sector-oriented perspectives to the overall effort of the committee, examined relevant issues and criteria, and made recommendations for improvement specific to the food groups under con- sideration (Chapters 4 through 7~. The final chapter (Chapter 8) summarizes the committee's findings and recommendations. As the study progressed, several members left the committee for various reasons. The committee thanks Emilio Esteban, who contributed his knowledge and enthusiasm to this report, and to George Hardy, who was appointed to the committee but could not join it. Similarly, the committee thanks Glenn Morris and Thomas Grumbly, who changed their status from members to committee consultants. 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 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 respon- siveness 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: Bill Aimutis, Cargill, Inc.; Christopher G. Atchison, The University of Iowa; Mindy Brashears, Texas Tech University; Dean 0. Cliver, University of Cali- fornia, Davis; Donald E. Conner, Auburn University; P. Michael Davidson, The University of Tennessee; Jeff Farrar, California Department of Health Services; George J. Flick, Jr., Virginia Polytechnic Institute and State University; John Floros, Pennsylvania State University; Carol Tucker Foreman, The Food Policy

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xlv PREFACE Institute, Consumer Federation of America; Linda Golodner, National Consumers League; Richard L. Hall, Independent Consultant, Food Industry; Myron M. Levine, The University of Maryland; Joseph M. Madden, Neogen Corporation; Nancy J. Rachman, Food and Chemical Practice Exponents, Inc.; Joan Rose, The University of South Florida; Robert E. Smith, R.E. Smith Consulting, Inc.; John Sofos, Colorado State University; Ewen C.D. Todd, Michigan State Uni- versity; Bruce R. Tompkin, Conagra Refrigerated Prepared Foods; Laurian Unnevehr, The University of Illinois; and Kaye Wachsmuth, Independent Consultant, Public Health Microbiology. Although the reviewers listed above have provided many constructive com- ments and suggestions, they were not asked to endorse the conclusions or recom- mendations nor did they see the final draft of the report before its release. The review of this report was overseen by Michael Doyle, University of Georgia, and Ronald W. Estabrook, University of Texas Southwestern Medical Center. 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 com- ments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. The co-chairs of the main committee and the chairs of the subcommittee, on behalf of the full committee, commend the staff for their excellence in support, editing, and contributions. Ricardo Molins, study director, was an invaluable resource to the committee members, bringing both a national and international perspective to the process in addition to assisting in building consensus among the committee members. The chairs also thank Maria Oria, program officer, for helping the committee focus on the issues of concern and for her valuable sugges- tions throughout the process. The committee is grateful to Tazima Davis, research assistant, and Sanait Tesfagiorgis, senior project assistant, for their support and dedication. The chairs would also like to acknowledge the helpful contributions of Allison Yates, director of the Food and Nutrition Board, whose leadership gave the committee the tools to build consensus on the issues, and of Charlotte Kirk Baer, director of the Board on Agriculture and Natural Resources. This report would not be possible were it not for the contributions of the staff and they have our deepest appreciation. It is with great satisfaction that we thank the committee, subcommittees, and consultants for sharing with us their knowledge and efforts in accomplishing the heavy task entrusted to us in a relatively short time and with an admirable display of teamwork. Claude Earl Fox, Cameron Hackney Co-Chairs, Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food

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Contents PREFACE ACRONYMS EXECUTIVE SUMMARY 1 HISTORICAL PERSPECTIVE ON THE USE OF FOOD SAFETY CRITERIA AND PERFORMANCE STANDARDS The Impact of Changing Scientific and Societal Conditions on Standards, 17 Fragmentation of the Current Regulatory System, 18 Development of New Regulatory Approaches, 20 References, 25 2 THE SCIENCE OF PUBLIC HEALTH SURVEILLANCE The Tools of Public Health Surveillance, 28 Results from Public Health Surveillance, 37 Monitoring Hazards in the Food Chain, 47 Pathogenesis, 53 Use of Public Health Data to Improve Food Safety: Specific Examples, 54 Anticipating the Future, 59 References, 60 xv xi xix 1 13

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xvi 3 FOOD SAFETY TOOLS Hazard Analysis and Critical Control Points, 69 Risk Assessment, 73 Food Safety Objectives, 88 Strategies for Developing Criteria and Performance Standards, 101 Statistical Tools to Verify Process Stability and Capability, 107 The Economics of Food Safety Criteria, 116 The Impact of Changing Technology: New Diagnostic Tools, 125 The Limits of Science, 126 References, 128 4 SCIENTIFIC CRITERIA AND PERFORMANCE STANDARDS TO CONTROL HAZARDS IN MEAT AND POULTRY PRODUCTS Description of the Meat and Poultry Industry, 133 Meat and Poultry Inspection, 136 Review of Current Standards for Meat and Poultry, 141 Application of Performance Standards Within the HACCP System, 162 Economic Costs and Benefits of the PR/HACCP Rule, 165 The Need for Additional Approaches to Reduce Microbial Hazards, 169 Do Meat and Poultry Performance Standards Improve Public Health?, 173 References, 174 5 SCIENTIFIC CRITERIA AND PERFORMANCE STANDARDS TO CONTROL HAZARDS IN SEAFOOD Description of the Seafood Industry, 181 Review of Current Food Safety Criteria for Seafood, 183 References, 194 6 SCIENTIFIC CRITERIA AND PERFORMANCE STANDARDS TO CONTROL HAZARDS IN PRODUCE AND RELATED PRODUCTS Fresh Fruits and Vegetables and Fresh-Cut Products, 197 Fruit and Vegetable Juices, 205 Low-Acid and Acidified Canned Foods, 211 Sprouts, 216 Pesticide Residues, 216 Food Defect Action Levels, 217 International Criteria, 218 CONTENTS 69 133 179 197

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CONTENTS Do Produce and Juice Performance Standards Improve Public Health?, 218 References, 220 SCIENTIFIC CRITERIA AND PERFORMANCE STANDARDS TO CONTROL HAZARDS IN DAIRY PRODUCTS Milk, 226 Cheese and Other Dairy Food Products, 233 The Role of the U.S. Department of Agriculture in Dairy Product Quality and Wholesomeness, 238 The Use of Current Standards and Criteria Under HACCP, 240 Are the Standards and Scientific Criteria for Milk and Dairy Products Achieving Their Goal?, 241 Economic and Administrative Feasibility of Milk Pasteurization, 245 References, 245 8 OVERALL FINDINGS AND RECOMMENDATIONS The Need for Regulatory Agencies to Have the Authority and Flexibility to Enact, Enforce, and Update Food Safety Criteria, 249 Linking Food Safety Criteria to Public Health Objectives, 249 Developing and Monitoring Science-Based Food Safety Criteria, 251 HACCP, 251 Scientific Criteria in Meat and Poultry, Seafood, Produce, and Dairy Products, 257 APPENDIXES A Current and Proposed Definitions of Key Food Safety Terms B Sanitation Performance Standards C Food and Drug Administration and Environmental Protection Agency Guidance Levels for Seafoods D Food Defect Action Levels in Produce E International Microbiological Criteria F International Microbiological Criteria for Dairy Products G U.S. Department of Agriculture Agricultural Marketing Service Standards for Milk and Dairy Products H Biographical Sketches of Committee and Subcommittee Members INDEX XVi1 225 248 273 294 303 309 317 359 366 370 379

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FarmSO Farm Safety Objective FSTS Food Safety Inspection Service (USDA) FSO Food Safety Objective HACCP Hazard Analysis and Critical Control Points HHS U.S. Department of Health and Human Services HIMP HACCP-Based Inspection Models Project HTST High-Temperature Short-Time ICMSF International Commission on Microbiological Specifications for Foods IFPA International Fresh-Cut Produce Association IFT Institute of Food Technologists IMS Interstate Milk Shipper ISSC Interstate Shellfish Sanitation Conference TOM Institute of Medicine of the National Academies ISSC Interstate Shellfish Sanitation Conference JECFA FAD/WHO Joint Expert Committee on Food Additives MCkG Maximum Contaminant Level Goal MDP Microbiological Data Program MRA Microbial Risk Assessment MRL Maximum Residue Level NACMCF National Advisory Committee on Microbiological Criteria for Foods NFPA National Food Processors Association NAHMS National Animal Health Monitoring System (USDA/APHTS) NCIMS National Conference on Interstate Milk Shipments NAS National Academy of Sciences NELS New Enhanced Line Speed NMFS National Marine Fisheries Service NRC National Research Council NOAEL No Observed Diverse Effect Level OCP Other Consumer Protection (Defects) OlG Office of Inspector General PCR Polymerase Chain Reaction PHS Public Health Service PHT Post-harvest Treatment PMO Grade A Pasteurized Milk Ordinance PSO Processing Safety Objective PR/HACCP Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) final rule (published by FSIS in 1996) QMRA Quantitative Microbial Risk Assessment RA Risk Assessment RIA Regulatory hop act Assessment RT} Research Triangle Institute RfD Reference Dose RTE Ready-to-Eat (Foods) RVIS Residue Violation Information System (FS1:S) S ERA Salmonella Enteritidis Risk Assessment SHA Seafood HACCP Alliance . . . xv

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Acronyms ALOP Appropriate level of protection AMS Agricultural Marketing Service APC Aerobic plate count APHIS Animal and Plant Health Inspection Service BRFSS Behavioral Risk Factor Surveillance System BSE Bovine spongiform encephalopathy CAC Codex Alimentarius Commission CCP Critical Control Point CDC Centers for Disease Control and Prevention CFR Code of Federal Regulations CSPI Center for Science in the Public Interest CVM Center for Veterinary Medicine DMC Direct microscopic count DNA Deoxyribonucleic acid EPA U.S. Environmental Protection Agency ETEC Enterotoxigenic Escherichia cold FAO Food and Agriculture Organization of the United Nations FarmSO Farm Safety Objective FDA Food and Drug Administration ax

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xx ACRONYMS FSO Food Safety Objective FSIS Food Safety and Inspection Service GAO U.S. General Accounting Office GAP Good Agricultural Practice GHP Good Hygienic Practice GLP Good Laboratory Practice GMP Good Manufacturing Practice HACCP Hazard Analysis and Critical Control Point HIMP HACCP-based Inspection Model Project ICMSF International Commission on Microbiological Specifications fog Foods IFPA International Fresh-cut Produce Association ISO International Organization for Standardization ISSC Interstate Shellfish Sanitation Conference JECFA FAD/WHO Joint Expert Committee on Food Additives MEN Most probable number mRNA Messenger ribonucleic acid NACMCF National Advisory Committee on Microbiological Criteria for Foods NAHMS National Animal Health Monitoring System NARMS National Antimicrobial Resistance Monitoring System NASA National Aeronautics and Space Administration NFSS National Food Safety System NOAEL No-observed-adverse-effect level NRC National Research Counci] OCP Other consumer protection PCR Polymerase chain reaction PHS Public Health Service PMO Grade A Pasteurized Milk Ordinance PR/HACCP Pathogen Reduction; Hazard Analysis and Critical Control Point Final Rule PSO Processing Safety Objective Quantitative microbial risk assessment

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ACRONYMS RA RTE RTI SCC SERA SPC TSRO USDA VTEC WHO WTO xx Risk assessment Ready-to-eat Research Triangle Institute Somatic cell count Salmonella Enteritidis risk assessment Statistical Process Control Transportation and Retail Safety Objective U.S. Department of Agriculture Verotoxigenic Escherichia cold World Health Organization World Trade Organization

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