Review of the Use of Process Control Indicators in the FSIS Public Health Risk-Based Inspection System

A Letter Report

Committee on Review of the Use of Process Control Indicators in the FSIS Public Health Risk-Based Inspection System

Food and Nutrition Board



Washington, D.C.

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Review of the Use of Process Control Indicators in the FSIS Public Health Risk-Based Inspection System A Letter Report Committee on Review of the Use of Process Control Indicators in the FSIS Public Health Risk-Based Inspection System Food and Nutrition Board

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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 Gov- erning 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 re- sponsible for the report were chosen for their special competences and with re- gard for appropriate balance. This study was supported by Contract No. AG-3A94-C-08-0018/AG-3A94-D- 08-0258 between the National Academy of Sciences and the Department of Ag- riculture. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. 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, For more information about the Institute of Medicine, visit the IOM home page at: Copyright 2009 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 al- most all cultures and religions since the beginning of recorded history. The ser- pent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2009. Review of the Use of Process Control Indicators in the FSIS Public Health Risk-Based Inspection System: A Letter Report. Washington, DC: The National Academies Press.

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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. Ralph J. Cicerone 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. Charles M. Vest 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 re- sponsibility 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 Insti- tute 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 Na- tional 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

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COMMITTEE ON REVIEW OF THE USE OF PROCESS CONTROL INDICATORS IN THE FSIS PUBLIC HEALTH RISK-BASED INSPECTION SYSTEM SANFORD A. MILLER (Chair), Center for Food, Nutrition, and Agri- culture Policy, University of Maryland GARY R. ACUFF, Department of Animal Science, Texas A&M Uni- versity ROBERT L. BUCHANAN, Center for Food Safety and Security Sys- tems, University of Maryland MICHAEL P. DOYLE, Center for Food Safety, University of Georgia JOHN J. MAURER, Department of Medical Microbiology and Parasi- tology, University of Georgia CRAIG A. REED, Large Animal Clinical Sciences, VA-MD Regional College of Veterinary Medicine STEVEN C. RICKE, Department of Food Science, University of Ar- kansas JULIANA M. RUZANTE, Joint Institute for Food Safety and Applied Nutrition, University of Maryland ROBERT TAUXE, Division of Foodborne, Bacterial and Mycotic Diseases, Centers for Disease Control and Prevention Consultant KERRI B. HARRIS, Department of Animal Science, Texas A&M Uni- versity Study Staff MARIA ORIA, Study Director ALICE VOROSMARTI, Research Associate GUI LIU, Senior Program Assistant GERALDINE KENNEDO, Administrative Assistant ANTON L. BANDY, Financial Associate LINDA D. MEYERS, Director, Food and Nutrition Board HILARY RAY, Editor v

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Reviewers 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 pub- lished report as sound as possible and to ensure that the report meets in- stitutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confi- dential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Russ Flowers, Silliker Corp. Randy Huffman, Maple Leaf Foods Lee-Ann Jaykus, Departments of Food Science and Microbiology, North Carolina State University Dale L. Morse, New York State Department of Health Donald Schaffner, Center for Advanced Food Technology, Rutgers, The State University of New Jersey 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 Jim E. Riviere, Center for Chemical Toxicology Research and Pharmacokinet- ics, College of Veterinary Medicine at North Carolina State University, and Harley W. Moon, Department of Veterinary Pathology, Professor Emeritus, Iowa State University. Appointed by the National Research Council and the 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 comments were carefully considered. Responsibility for the final content of this re- port rests entirely with the authoring committee and the institution. vi

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Contents Summary 1 Charge to the Committee 4 Background 6 Overall Findings and Recommendations 8 Findings and Recommendations on Specific Process Indicators 23 Other Potential Indicators of Process Control 53 Conclusion 56 APPENDIXES A Meeting Agendas 61 B Levels of Inspection 65 C Acronyms 71 D Glossary 73 E Biographical Sketches of Committee Members 83 vii

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