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CATm' LE NSP~TION Committee on Evaluation of USDA Streamlined Inspection System for Caine /CTO ~\ Food And Nutrition Board Institute of Medicine National Academy of Sciences National Academy Press Washington, D.C. 1990

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National Academy Press ~ 2101 Constitution Avenue, N.W. ~ Washington, D.C. 20418 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 Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Samuel O. Thier is president of the Institute of Medicine. This study was supported by contract no. 53-3A94-9-06 from the Food Safety and Inspection Service, U.S. Department of Agriculture. Library of Congress Catalog Card No. 90-62817 International Standard Book Number 0-309-04345-X Copyright ~ 1990 by the National Academy of Sciences The cover photo was taken by Larry LeFever of Grant Heilman Photography, Inc., 506 West Lincoln Avenue, Lititz, PA 17543, which provided the photo. Additional copies of this report are available from: National Academy Press 2101 Constitution Avenue, NW Washington, DC 20418 S228 No part of this book may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use, without written permission from the publisher, except for the purposes of official use by the U.S. Government. Printed in the United States of America

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COMMITTEE COMMITTEE ON EVALUATION OF USDA STREAMLINED INSPECTION SYSTEM FOR CATTLE ROBERT F. KAHRS (Chainnan), Dean, College of Veterinary Medicine, University of Missouri-Columbia, Columbia, Missouri HELEN M. ACLAND, Associate Professor of Pathology, School of Veterinary Medicine, University of Pennsylvania, Kennett Square, Pennsylvania ROGER G. BREEZE, Director, USDA-ARS Plum Island Animal Disease Center, Greenport, New York GRAHAM C. CLARKE, Chief of National Programs, Meat and Poultry Products Division, Food Production and Inspection Branch, Agriculture Canada, Ottawa, Ontario, Canada DONALD M. KINSMAN, Professor Emeritus, Department of Animal Science, University of Connecticut, Storrs, Connecticut FARREL R. ROBINSON, Chief of Toxicology Service, Animal Disease Diagnostic Laboratory, School of Veterinary Medicine, Purdue University, West Lafayette, Indiana CONSULTANTS STANLEY M. MARTIN, Chief of Statistical Services Activity, Division of Bacterial Diseases, Centers for Disease Control, Atlanta, Georgia I. GLENN MORRIS, JR., Associate Professor of Internal Medicine, Division of Geographic Medicine, University of Maryland School of Medicine, Baltimore, Maryland MORRIS E. POTTER, Epidemiologist, Division of Bacterial Diseases, Centers for Disease Control, Atlanta, Georgia STUDY STAFF FARID E. AHMED, Project Director, Food and Nutrition Board FRANCES M. PETER, Editor, Institute of Medicine . . .

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FOOD AND NUTRITION BOARD RICHARD ]. HAVEL (~Chairman), Cardiovascular Research Institute, University of California School of Medicine, San Francisco, California DONALD B. McCORMICK (Vice Chairman), Department of Biochemistry, Emory University School of Medicine, Atlanta, Georgia EDWIN L. BTERMAN, Division of Metabolism, Endocrinology, and Nutrition, University of Washington School of Medicine, Seattle, Washington EDWARD I. CALABRESE, Environmental Health Program, Division of Public Health, University of Massachusetts, Amherst, Massachusetts DORIS H. CALL`OWAY, University of California, Berkeley, California DeWITT GOODMAN, Institute of Human Nutrition, Columbia University, New York, New York M.R.C. GREENWOOD, University of California, Davis, California JOAN D. GUSSOW, Department of Nutrition Education, Teachers College, Columbia University, New York, New York JOHN E. KINSELLA, Institute of Food Science, Cornell University, Ithaca, New York LAURENCE N. KOLONEL, Cancer Center of Hawaii, University of Hawaii, Honolulu, Hawaii REYNALDO MARTORELL, California Food Research Institute, Stanford University, Stanford, WALTER MERTZ, Human Nutrition Research Center, U.S. Department of Agriculture, Beltsville, Maryland MALDEN C. NESHEIM, Office of the Provost, Cornell University, Ithaca, New York JOHN LISTON (Ex Officio), Division of Food Science, School of Fisheries, College of Ocean and Fishery Sciences, University of Washington, Seattle, Washington ARNO G. MOTUESKY (Ex Officio), Center for Inherited Diseases, University of Washington, Seattle, Washington ROY M. PITKIN (Ex Officio), Department of Obstetrics and Gynecology, School of Medicine, University of California' Los Angeles, California Agricultural Research Service, Staff CATHERINE E. WOTEKI, Director SHIRLEY ASH, Financial Specialist UTE HAYMAN, Administrative Assistant 1V

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Preface Since the early 1900s, the U.S. Department of Agriculture (USDA) has been responsible for mandatory federal meat inspection programs, which remained essentially unchanged into the 1980s. In 1980, USDA's Food Safety and Inspection Service (FSIS) asked the Food and Nutrition Board of the National Academy of Sciences (NAS) to conduct scientific evaluations of its meat and poultry inspection programs. The Food and Nutrition Board's recommendations were released in two reports published in 1985 and 1987 (NRC, 1985a, 1987a). Meanwhile, FSIS worked to modernize inspection in high speed slaughter operations through streamlined inspection systems (SIS). These systems were introduced to ensure more efficient use of inspection personnel, to help industry to become more efficient, and to assist the agency's transition to a more public health-oriented inspection. They initiated SIS in pilot plants and published the proposed rule in the Federal Register in November 1988 (Fed. Regist., 1988; Appendix A). In response to questions raised about the proposed rule, FSIS asked the Food and Nutrition Board to evaluate SIS for cattle (SIS- C) for acceptability as an alternative to traditional slaughter inspection. This six member committee was convened under the auspices of the Institute of Medicine's (IOM) Food and Nutrition Board (FNB) in conjunction with the National Research Council's (NRC) Board on Agriculture. The committee and its three consultants included experts in biostatistics, epidemiology, meat science, meat inspection, public health, veterinary pathology, veterinary microbiology, and veterinary toxicology. The committee was charged with the following tasks: 0 Evaluate SIS-C as compared to the traditional cattle inspection system and its acceptability as an alternative to traditional cattle slaughter inspection. 0 Perform on-site reviews of two high volume cattle slaughtering plants (establishments) operating under traditional inspection and two plants operating as pilot studies for SIS-C. o o SuIvey procedures for monitoring chemicals and pathogens in carcasses. Examine how this proposed system has integrated recommendations in the 1985 and 1987 reports, which called for FSIS to pursue new scientific directions, address contemporary public expectations for meat and poultry products, and work toward an ideal meat inspection program. O Evaluate efficacy of STS-C in protecting the public's health. v

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The committee received an overview of SIS-C from FSIS management, heard testimony from eight witnesses at a public hearing, and then visited three SIS-C pilot plants and two traditionally inspected plants. Altogether, it met six times. Throughout the study, the committee also requested and received additional data from FSTS (Appendix B). During their presentation to the committee, FSTS staff indicated that traditional inspection procedures were serving as the baseline for modernizing inspection and as a springboard for future improvements. FS S emphasized that SIS-C Is not a system for detecting microbial or chemical contaminants and that it is not a Hazard Analysis Critical Control Point (HA CCP) program but, rather' Is a single step toward those goals. FSIS regards SIS-C as an innovative system that identifies control points, increases use of plant personnel in quality control and in presentation of carcasses and parts for inspection, and incorporates statistical samples and tests to monitor products and the slaughter process. SIS-C differs from traditional inspection in several ways. In traditional inspection programs, FSIS inspectors incise the bile ducts, heart, cheek muscles, and numerous lymph nodes seeking visible lesions. Inspectors are responsible for condemnation and disposition of diseased carcasses. FSIS inspectors also identify and supervise the trimming of carcasses with various dressing defects and nonconformances. Under SIS-C, plant employees incise the heart and cheek muscles, position parts for inspectors, and assume responsibility for dressing nonconformances and designated trimmable conditions (see Chapter 3~. FSIS leadership believes that these conditions can be recognized by personnel with limited experience, are susceptible to market pressures, and are the responsibility of plant management. Under STS-C, however, inspectors are still responsible for condemnation and disposition of diseased carcasses and still examine every head, viscera, and carcass. In conjunction with STS-C, plants killing more than 275 cattle per hour must have a formal written, customized, partial quality control (PQC) program. SIS-C~QC programs require the plant to identify control points, establish standards, and take actions when FSIS-supervised monitoring reveals that standards are unmet. Plants unable to implement SIS-C~QC successfully must operate at chain speeds below 275 cattle per hour. The SIS-C system is currently in effect in five pilot plants conducting high speed, high volume slaughter of fed steers and heifers -- a class of animal with low prevalence of conditions detectable by traditional meat inspection procedures. Approximately 80 of more than 1,300 USDA-inspected cattle slaughter plants would be eligible for SIS-C were the proposed rule implemented. The eight speakers who addressed the committee during the public meeting held on January 23, 1990, represented consumer advocates, the meat industry, food inspectors, former USDA scientists and inspectors, and national associations (Appendix C). Some of their testimony criticized FSTS for previous deficiencies in inspection programs, for failure to emphasize public health, for unwillingness to listen to the scientific community, for reluctance to improve its technologic capacity, for failure to incorporate recommendations V1

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in previous Food and Nutrition Board reports, and for fundamental flaws in SIS-C. Several speakers criticized SIS-C because responsibility for quality control is given to management of meat plants. This abdication, it was said, compromises the integrity of FSIS and is not feasible because it requires ideal conditions in every plant and requires plant employees to place the public interest above profit considerations. Witnesses also stated that SIS-C is flawed because head, viscera, and carcass inspection are all compromised and there is no assurance that company personnel are properly trimming contaminated areas from carcasses. These problems are compounded by staff reductions and increased paperwork for the inspection force. The opinion was expressed that SIS-C lacks clear rational statements of goals and definitions for its sampling plans and that solid scientific data supporting those plans are absent. Meat industry representatives questioned USDA-FSIS's ability to regulate plant quality control programs. They suggested that clear guidelines and appeal procedures are needed if the government assumes this role. Most witnesses emphasized concern about microbial and chemical contaminants. The committee had to deal early with the real distinction between safety and quality because FSIS contends SIS-C is not designed to detect and remove these contaminants. The FSIS chemical residue monitoring program whether in traditional or SIS-C plants is designed to provide incidence information -- not to prevent public exposure to residues. The committee visited three SIS pilot plants (in Texas, Colorado, and Nebraska) and two traditionally inspected plants (in Texas and Kansas). Its findings from these site visits are summarized in Appendix D. The committee interviewed 24 lay food inspectors, 6 inspectors in charge, 5 veterinarians, 5 supervising veterinarians (including one area supervisor), 7 representatives of plant management, and 9 plant quality control personnel. From the outset, it was apparent that people were concerned about food safety, meat and poultry inspection, and SIS-C. The committee received sworn affidavits and letters from inspectors and veterinarians who were disillusioned with SIS-C (see Appendix E) and many letters from one veterinarian who was formerly an FSIS employee. The committee was also bombarded with testimony, many other letters, information, undocumented anecdotes, newspaper clippings, and dogmatic statements assailing SIS and blaming it for imperfections in meat and poultry inspection programs. Much of this input implied that the public expects the government to ensure zero risk of meat-borne disease through inspection. The committee heard little evidence that the public is aware that some bacterial contamination of raw meat is inevitable and no mention of the crucial role of food handling, preparation, and serving methods in limiting foodborne diseases. The committee was chosen for its diversity and scientific credibility. Because of its charge, it considered only commentary relevant to SIS-C. It was a challenge to sort through the emotions, political motivations, hidden agendas, and vested interests of people presenting opinions and recommendations. Because of the lack of hard quantitative data, ~ V11

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it was difficult to separate perception from fact. This complex controversial issue abounds with unsubstantiated accusations, subjective opinions, and deep emotional involvements. The committee did its best to listen carefully, to be critically analytical, and to address the specific charge. Although the report deals only with beef cattle slaughter and SIS-C, the committee addressed some recommendations dealing with poultry in one of the earlier reports (NRC, 1987a) when it believed they had application to beef slaughter and the FSIS mission. The committee hopes the report is fair and will serve the best interests of the American people. Chapter ~ (the Executive SummaIy) summarizes the committee's charge, findings, conclusions, and recommendations. Chapter 2 provides an introduction and a historic overview of meat inspection and public concerns about food safety. In Chapter 3, the committee examines the proposed STS-C ruling, its rationale, and its potential impact on consumers. The statistical procedures used in SIS-C are discussed in Chapter 4. Chapter 5 contains a discussion of microbiological and toxicological data. An example of how to collect and analyze microbiological samples is presented in Appendix F. Chapter 6 discusses how the proposed SIS rule could have incorporated recommendations in the earlier Food and Nutrition Board reports. A GIossa~ of terms and acronyms can be found in Appendix G. The affiliations and major research interests of committee members and staff are presented in Appendix H. The committee commends the assistance, hard work, and support of the FNB staff: Dr. Farid E. Ahmed, for the organizational and administrative support of the committee's work, Frances Peter for editing the report, and Barbara Matos for typing the document. The committee expresses its appreciation to FSIS personnel for expediting facility visits and providing data, to all the plant personnel who extended hospitality, and to all the witnesses who testified at the public hearing. The committee is also grateful to the anonymous USDA inspectors and veterinarians and many plant employees who volunteered time and shared their concerns. As chairman, ~ also thank the committee members and consultants and their employers; they volunteered countless hours and effort to produce an objective and timely report on a controversial subject that is a small part of a major national issue -- the safety of the food supply. ~ /~ Robert F. Kahrs, Chairman Committee on Evaluation of USDA Streamlined Inspection System for Cattle . . vail

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Contents Executive summary Committee charge, its response, and its conclusions Recommendations 2 3 Introduction and Historical Review of Meat Inspection Abstract Historic food safety concerns and early meat inspection legislation Developments after the Meat Inspection Act of 1906 Emergence of HACCP as a mode] inspection system Contemporary public concerns about meat inspection Conclusions The Proposed STS Rule Abstract Rationale and assumptions of the ruling An overview and commentary on SIS-C and the slaughter PQC program STS-C postmortem inspection Streamlined inspection procedures Cervical/head inspection Viscera and carcass inspection Uniform presentation standards Specific equipment and facilities Carcass dressing requirements Assessing the wholesomeness of the carcass and product FS:IS data in support of the proposed ruling Impact of SIS-C on consumers, inspectors and plants Consumers Inspectors Plant managers and employees Conclusions and recommendations Statistical Considerations Abstract Rationale supporting the change from AQL to SIS Use of CUSUM for process control The sampling basis for CUSUM Discussion LY 1 3 6 8 8 8 9 13 14 15 16 16 16 17 19 19 19 22 23 23 23 24 26 27 27 28 29 29 34 34 34 35 36 38

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Discussion Recommendations s Microbiologic and Toxicologic Assessment Abstract Assessment Recommendations 6 The Extent to Which Previous FNB Recommendations Have Been Integrated into the SIS Proposed Rule Abstract Recommendations in Meat and Poultry Inspection: The Scientific Basis for the Nation's Program Recommendations Detection and elimination of pathogenic microorganisms Preventing and detecting chemical residues Monitoring hazardous agents during livestock production and traceback mechanisms Integration of risk assessment procedures into the inspection process Research and advisory programs to develop high technology-based inspection Characteristics of an optima] meat and poultry inspection program A system of traceback to producers Use of plant personnel to monitor critical control points Use of contemporary technologic expertise in inspection management Multitiered levels of inspection Analysis of the utility of each inspection procedure Develop a data base on specific causes of condemnations Rapid screening for residues Protection of consumers from residues Hazard Analysis Critical Control Point (HACCP) Programs Documentation and compliance enforcement Enhanced enforcement capability Improve technologic base of FSIS Mandatory continuing education Involvement of scientists in policy development Expert advisory panels Interagency liaison Data and information analysis Implementation timetable Recommendations in Poultry Inspection: The Basis for a Risk-Assessment Approach x 38 40 42 42 42 46 48 48 49 49 49 50 50 51 51 51 52 52 52 53 53 54 54 55 55 55 56 56 57 57 57 58 58 59 59

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General recommendations Specific Recommendations Conclusions References Appendices: A Proposed Rule. Streamlined Inspection System-CattIe and Staffing Standards B Information Provided by USDA-FSIS to Committee C Public Meeting Agenda D Reports on Site Visits E Summary of Verbal and Written Testimony by FS1:S Inspectors F Bacteriological Study of Beef Carcasses in Quebec Annex 1 Data Sheet for Establishment Annex 2 Needle Point Stamp for Marking Samples to be Taken Annex 3 Areas From Which Samples are to be Taken and Location of Points at Which to Take Temperature and Relative Humidity Readings G Glossary of Terms and Acronyms H Affiliations and Major Research Interests of Committee and Staff Tables: 2-1 Analyses Performed by FSIS in 1989 3-1 An Overview of the SIS-C/PQC Program 3-2 SIS-C and Traditional Postmortem Inspection Procedures 3-3 Size and Frequency of Sampling by Plant QC Personnel and FSIS Inspectors 5-1 Classification of Worldwide Meatborne and Poultryborne Microbial Pathogens According to Modes of Transmission F. figures: 3-1 Interactions Between Plant Process Control Operations and Plant Quality Control and Federal Meat Inspection Staff 4-] Probability of Observing No Defects in Various Lot Sizes and Line Speeds When the Average Number of Defects/Sample Unit (Carcass Side) is 0.1 4-2 Evaluation of CUSUM for SIS-C, Assuming n=3, c=0 X1 59 60 63 65 67 68 82 84 86 88 90 94 97 98 99 103 12 18 21 25 43 20 37 39

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