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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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