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The Basis for a Risk-Assessment Approach Prepared by the Comn:~ittee on Public Health Risk Assessment of Poultry Inspection Programs , Food and Nutrition Board . . . i- ,, . Comrmsslon on Llre Sciences National Research Council NATIONAL, ACADEMY PRESS Washington, D.C. 1987

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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 report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of 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. Frank Press 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. Robert M. White 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. Samuel O. Thier 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. Frank Press and Dr. Robert M. White are chairman and vice chairman, respectively, of the National Research Council. The study summarized in this report was supported by the Food Safety and Inspection Service of the U.S. Department of Agriculture under Contract No. 53-3A94-4-01. LIBRARY OF CONGRESS CATALOG CARD NUMBER 87-60910 INTERNATIONAL STANDARD BOOK NUMBER 0-309-03743-3 Printed in the United States of America First Printing, May 1987 Second Printing, July 1987

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COMMITTEE ON PUBLIC HEALTH RISK ASSESSMENT OF POULTRY INSPECTION PROGRAMS JOSEPH RODRICKS (Chairman). Environ Corp., Washington, D.C. JOHN C. BAILAR ITI (Vice Chairman), Harvard School of Public Health, Harvard University, Boston, Mass., and Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services, Washington, D.C. THOMAS CRUMBLY, Health Effects Institute, Cambridge, Mass. MILKY W. MERKHOFER, Applied Decision Analysis, Inc., J. GLENN MORRIS, Md . Menlo Parks Calif. School of Medicine, University of Maryland, Baltimore, MORRIS POTTER, Division of Bacterial Diseases, Centers for Disease Control, U.S. Public Health Service, Atlanta, Ga. MICHAEL POLLEN, Department of Large Animal Clinical Sciences, College of Veterinary Medicine, University of Minnesota, St. Paul, Minn. National Research Council Staff ROBERT A. MATHEWS, Proj ect Manager SHAK~TALA CHAUBE, Program Officer FARID E. ARMED, Senior Program Officer LANCES PETER, Editor ELIZABETH J. HAMILL, Research Assistant KAMAR PATEL, Secretary SUSHMA PALMER, Director, Food and Nutrition Board . . .

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FOOD AND NUTRITION BOARD KURT J. ISSLEBACHER (Chairman), Department of Gastroenterology, Massachusetts General Hospital, Boston, Mass. RICHARD J. HAVEL (Vice Chairman), Cardiovascular Research Institutes University of California School of Medicine, San Francisco, Calif . HAMISH N. MUNRO (Vice Chairman), USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Masse WILLIAM E. CONNOR, Department of Medicine, Oregon Health Sciences Univers ity, Portland, Oreg . PETER GREENWALD, Division of Cancer Prevention and Control, National Cancer Institute, Bethesda, Md. M. R. C . GREENWOOD, Department of Biology, Vassar College, Poughkeepsie a N aYo JOAN D. GUSSOW, Department of Nutrition Education, Teachers College, Columbia University, New York, N.Y. JAMES R. KIRK, Research and Development, Campbell Soup Company, Camden, N.J. BERNARD J. LISKA, Department of Food Science, Purdue University, West Lafayette, Ind. REYNALDO MARTORELL, Food Research Institute, Stanford University, Stanford, Calif. WALTER MERTZ, Human Nutrition Research Center, Agricultural Research Service, UOS. Department of Agriculture, Beltsville, Mdo MALDEN C. NESHEIM, Division of Nutritional Sciences, Cornell University, Ithaca, N . Y. RONALD C. SHANK, Department of Community and Environmental Medicine and Department of Pharmacology, University of California, Irvine5 Calico ROBERT H. WASSERMAN, Department/Section of Physiology, New York State College of Veterinary Medicine, Ithaca, N.Y. MYRON WINICK, Institute of Human Nutrition, College of Physicians and Surgeons, Columbia University, New York N.Y. JO MICHAEL McGINNIS (Ex Officio), Office of Disease Prevention and Health Promotion, Department of Health and Herman Services, Washington, DoCO ARNO G. MOTULSKY (Ex Officio), Center for Inherited Diseases, University of Washington, Seattle, Wash. National Research Council Staff SUSHMA PALMER, Di rector 1V

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PREFACE In 1985, a committee of the National Research Council's Food and Nutrition Board (FNB) completed a report on the scientific basis of the Department of Agriculture ' s (USDA) meat and poultry inspection programs. In that study, at the request of the Food Safety and Inspection Service (FSIS) the committee specifically considered whether bird-by-bird inspection as currently done should be modified to a less-than-continuous procedure. The committee concluded that before the traditional postmortem inspection methods are displaced, a comparative risk analysis of traditional and modified inspection procedures is needed. In other words, FSIS should first determine the relative effectiveness of the inspection procedures that would replace the traditional methods. In response to this observation, the FSIS Administrator requested that the National Research Council conduct a follow-up study, specifically regarding poultry production, with the following objectives: o o o Development of a risk-assessment model applicable to the poultry production system and an explanation of how it might be used to evaluate poultry inspection procedures. A general evaluation of current ESIS poultry inspection programs using the conceptual framework of the model . An assessment of the advantages of incorporating statistical sampling into poultry inspection procedures. In response , a committee was appointed to conduct the study under the auspices of FNB within the Commission on Life Sciences. The multidisciplinary group appointed contained members with expertise in public health, food microbiology, toxicology, risk assessment, risk management, veterinary pathology, poultry inspection technology, biostatistics, and epidemiology. In cooperation with FSIS a formal charge was developed to guide the committee's work. The information used to prepare this report included data from FSIS, the scientific literature, and other sources. The committee also had the opportunity to visit and inspect two poultry production plants. Opinions regarding the usefulness of poultry inspection were heard from federal veterinarians, poultry producers, and consumer representatives. The committee met five times during the study to review and evaluate this information with the goal of producing a report with conclusions and recommendations that would be useful to FSIS . A summary of the committee ' s findings , conclusions, and recommenda- tions appears in Chapter 1, The Executive Summary. Chapter 2 provides a historical background and a description of current poultry procedures. In Chapter 3 the committee describes its risk model. Chapters 4 and S apply the model to identify risks associated with v

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microbiological and chemical contamination of poultry. The current PSIS poultry inspection program is evaluated in Chapter 6. Chapter 7 is a review of the conclusions and recommendations of the committee. The committee expresses its appreciation to the following USDA staff members who were instrumental in arranging the site visit and providing information about poultry inspection procedures: Douglas Berndt, Robert Cook, William James, Marshall McCoulskey, Judith Segal, and John Prucha. The committee is grateful for the invaluable assistance of the following people who provided testimony or written material: Diane Heiman, Public Voice for Food and Health Policy; Edward Mennings, National Association of Federal Veterinarians; Carl Telleen, National Joint Council for Food Inspection Locals; and Frank Craig, National Broiler Council. The committee is also grateful to Frederick A. Murphy, Leigh Ao Sawyer, and Jeffrey A. Farrar of the Division of Viral Diseases, Center for Infectious Diseases, Centers for Disease Control 9 who provided information on avian viral diseases. On behalf of the committee I would also like to thank Zain Abedin. Parid Ahmed, Shakuntala Chaube, and Robert Mathews of the FNB staff for providing the organizational and administrative support needed to complete the report in a timely manner. We wish also to acknowledge the contributions of Sushma Palmer, Director of FNB, and the assistance of Frances Peter, CLS editor; Elizabeth Mill, FNB research assistant; and Kamar Patel, proj ect secretary. Of course, the report could not have been completed without the unfailing volunteer efforts of the committee. I am grateful for their commitment to preparing a document of the highest quality Joseph Rodricks Chairman Committee on Public Health Risk Assessment of Poultry Inspection Programs ~T1

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CONTENTS 1 EXECUTIVE SUMMARY. e ~ e 0 ~ ~ e ~ e 0 ~ e e ~ e ~ ~ e e e e e e e e ~ e e e ~ ~ e ~ ~ ~ 1 General Conclusions, 2 General Recommendations, 3 A Risk Assessment Model for Poultry-Associated Hazards, 4 Conclusions, 4 Recommendations, 5 Microbiological Hazards and Poultry, 5 Conclusions, 6 Recommendations, 6 Chemical Hazards and Poultry, 7 Conclusions, 7 Recommendations, 8 Current FSIS Programs and Statistically Based Sampling, 9 Conclusions, 10 Recommendations, 10 2 POULTRY INSPECTION IN THE UNITEI) STATES: PROCEDURES ~ e e e e e e e ~ e e e e ~ e e e e e ~ e ~ e ~ e ~ ~ e e ~ e ~ ~ e e ~ e e ~ e Poultry Inspection Activities, IS Antemortem Inspection, 16 Postmortem Inspection, 16 Condemnation and Final Disposition, 18 Sanitary Slaughter and Dressing, 18 Poultry Chilling, 18 Plant Sanitation, 19 Carcass Reinspection, 20 Residue Monitoring, 20 Changing Environment for Poultry Production and Regulation, 22 Alternative Postmortem Poultry Inspection Procedures, 23 Concerns Regarding the Health Impacts of New Inspection Systems, 26 The Need for Risk Assessment, 26 References, 27 HISTORY AND CURRENT 3 12 RISK-ASSESSMENT MODEL FOR POULTRY INSPECTION: Overview of the Analytical Approach, 30 Poultry Risk Agents, 32 The Risk Model, 32 Production Submodel, 33 Slaughter Submodel, 36 Packing and Further Processing Submodel, 40 Distribution and Preparation Submodel, 41 Health Effects (Consumption) Submodel, 42 Use of the Risk Model, 44 Using Risk Assessments to Protect Health, 46 Establish Priorities, 48 Identify Problems of Risk Management, and Set Acceptable Levels of Risk, 49 Monitoring and Surveillance, 49 References, 50 ANALYTICAL APPROACH. 30 ~ . V11

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APPLICATION OF THE MODEL TO MICROBIOLOGICAL HAZARDS.... Methodology Used To Describe and Identify Risks, 56 Hazard Identification and Evaluation, 56 Dose-Response Studies, 59 Potential for Human Exposure, 60 Characterization of Risk, 62 Application of Methods to Individual and Groups of Poultry- Borne Pathogens, 62 Known Human Pathogens Carried on or Transmitted by Broiler Chickens at Retail, 63 Microorganisms Known to be Pathogenic in Chickens That Are of Questionable Significance as Food-Borne Pathogens Transmitted by Broiler Chickens, 76 Using the Risk Model to Develop Programs and Strategies, 79 Risk Assessment, 80 Risk Management, 83 Implications of the Proposed Risk Model for Microbial Contamination for the Current FSIS Inspection Program, 85 References, 86 5 APPLICATION OF THE MODEL TO CHEMICAL HAZARD So .o 100 General Methods for Assessing the Public Health Risks of Chemicals, 100 The Components of Risk Assessment, 101 Hazard Identification, 101 Dose-Response Assessment, 106 Exposure Assessment, 108 Risk Characterization, 112 Uses of Risk Assessment in Standard Setting, 117 Food and Color Additives, 117 Animal Drug Residues on Food, 117 Pesticide Residues on Food, 117 Environmental Contaminants, 118 Limitations and Uncertainties in Risk Assessment, 118 Chemical Residues in Poultry Products and Their Public Health Risks, 119 Sources and Types, 119 Type and Magnitude of Risk, 121 Us ing Risk Assessment to Establish Risk-Management Programs, 122 Activity 1. Identifying Chemicals of Potential Concern, 12 3 Activity 2. Risk Assessment to Identify ADIs or Other Tolerable Intake Levels, 124 Activity 3. Estimating Tolerances in Edible Poultry Products, 126 Activity 4. Identifying Acceptable Levels of Chemical Intake for Poultry, 126 Activity 5. Feed and Water Quality Control, 127 Activity 6. Monitoring of Poultry Products, 128 Activity 7 . Enforcement, 129 Activity 8 ~ Establishing Priorities, 129 viii

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Assessing Relative Risks, 129 Special Problems, 134 Class 4 Substances, 134 Metabolites and Degradation Products, 135 Assessing Public Health Risks of Chemical Residues ~ n Poultry Products, 135 References, 136 6 APPLICATION OF THE MODEL TO THE CURRENT FSIS INSPECTION SYSTEM 140 The Poultry Production Submodel, 140 Breeding, 140 Hatching, 141: Grow-Out, 141 Sanitation, 141 Feed Milling and Feed Protection, 142 Natural Toxicants and Other Environmental Contaminants, 143 Transit, 144 Slaughtering Submodel, 144 Antemortem Inspection, 145 Approval of Slaughtering Facilities, 145 Stun, Scald, and Pluck, 146 Evisceration and Postmortem Inspection, 146 Chemical Traceback, 149 National Residue Program, 149 Washing and Chilling to Inhibit Microbial Growth, lS1 The Packing and Processing Submodel, 152 Distribution and Preparation Submodel, 153 Transport to Retailer, 153 Handling in the Retail System, 153 The Multiple Roles of Labeling, 153 Food Preparation, 1S4 Overall Evaluation, 155 References, 155 7 CONCLUSIONS AND RECOMMENDATIONS 158 Conclusions, 158 The Role of Risk Assessment, 158 The Risk Model, 159 Current FSIS Programs, 159 Recommendations, 161 General, 161 Microbiological Contaminants, 162 Chemical Residues, 163 Sampling Procedures, 164 ix

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