Ensuring Safe Food From Production to Consumption

Committee to Ensure Safe Food from Production to Consumption

INSTITUTE OF MEDICINE

NATIONAL RESEARCH COUNCIL

NATIONAL ACADEMY PRESS
Washington, D.C.
1998



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Ensuring Safe Food From Production to Consumption Committee to Ensure Safe Food from Production to Consumption INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL NATIONAL ACADEMY PRESS Washington, D.C. 1998

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NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 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. 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 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. William 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 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. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to link 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 Alberts and Dr. William A. Wulf are chairman and vice-chairman, respectively, of the National Research Council. This material is based upon work supported by the U.S. Department of Agriculture, Agricultural Research Service, under Agreement No. 59-0790-8-013. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author and do not necessarily reflect the view of the U.S. Department of Agriculture. Library of Congress Cataloging-in-Publication Data 98-86932 International Standard Book No: 0-309-06559-3 This report is available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055, Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP's on-line bookstore at http://www.nap.edu. ©1998 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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COMMITTEE TO ENSURE SAFE FOOD FROM PRODUCTION TO CONSUMPTION JOHN C. BAILAR III* (Chair), Department of Health Studies, The University of Chicago, Illinois CAROLE A. BISOGNI, Division of Nutritional Sciences, Cornell University, Ithaca, New York DAVID L. CALL, Retired, College of Agriculture and Life Sciences, Cornell University, Ithaca, New York MARSHA N. COHEN, Hastings College of the Law, University of California, San Francisco MICHAEL P. DOYLE, Center for Food Safety and Quality Enhancement, University of Georgia, Griffin DELIA A. HAMMOCK, Good Housekeeping Institute, New York LONNIE J. KING, College of Veterinary Medicine, Michigan State University, East Lansing GILBERT A. LEVEILLE, Leveille Associates, Denville, New Jersey RICHARD A. MERRILL,* University of Virginia School of Law, Charlottesville, Virginia SANFORD A. MILLER, Graduate School of Biomedical Sciences, University of Texas Health Science Center, San Antonio HARLEY W. MOON,† Veterinary Medical Research Institute, Iowa State University, Ames MICHAEL T. OSTERHOLM, Minnesota Department of Health, Minneapolis THOMAS D. TRAUTMAN, General Mills, Minneapolis, Minnesota Staff ALLISON A. YATES, Study Director CHARLOTTE KIRK BAER, Senior Program Officer SANDRA A. SCHLICKER, Senior Program Officer ELISABETH REESE, Research Associate KATHERINE J. GORTON, Policy Intern GAIL E. SPEARS, Administrative Assistant SHIRLEY B. THATCHER, Administrative Assistant GERALDINE KENNEDO, Project Assistant MELINDA SIMONS, Project Assistant *   Member, Institute of Medicine. †   Member, National Academy of Sciences.

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FOOD SAFETY OVERSIGHT COMMISSION DONALD KENNEDY (Chair),† * Institute for International Studies, Stanford University, California DALE E. BAUMAN,† Cornell University, Ithaca, New York FERGUS M. CLYDESDALE, University of Massachusetts at Amherst JOHANNA T. DWYER, Tufts Medical School and School of Nutrition Science and Policy, New England Medical Center, Boston, Massachusetts JOHN W. ERDMAN, Jr., College of Agriculture, University of Illinois at Urbana-Champaign CUTBERTO GARZA, Cornell University, Ithaca, New York GEORGE R. HALLBERG, The Cadmus Group, Inc., Waltham, Massachusetts JOHN W. SUTTIE,† University of Wisconsin-Madison BAILUS WALKER, Jr.,* Howard University Cancer Center, Washington, DC Staff PAUL GILMAN, Executive Director, Board on Agriculture KAREN HEIN, Executive Officer, Institute of Medicine MICHAEL J. PHILLIPS, Director, Board on Agriculture ALLISON A. YATES, Director, Food and Nutrition Board *   Member, Institute of Medicine. †   Member, National Academy of Sciences.

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Preface Protecting the food supply from harmful agents and thus promoting the public health is an important activity of government. The current system for food safety in the United States is a complex and multi-layered activity that depends on multiple players that include the federal government, state governments, local governments, universities, the news media, and, of course, the public itself, both as preparers and handlers of food and as consumers. These varied roles which each segment plays in food safety, with their many complexities and charges, must be integrated within the equally complex and changing system of the food supply from production to final consumption. Though the federal roles of guidance, research, surveillance, enforcement, and education are extremely important, they represent only one part of the food safety system. Given the size and complexity of this multi-faceted system, it is not unexpected that new information and new concerns often emerge. Many are due to advances in science or to changes in food production and consumption patterns. The system itself must then change if it is to maintain effective vigilance over the safety of the food supply. Congress has acted to strengthen the federal role as the primary agent for integration of activities related to food safety. Many components of the federal food safety system determined by Congress have been relatively unchanged over the last few decades, and concerns have come forward that major changes may be required. At the request of Congress, and in light of the emerging food safety concerns and many recent proposals recommending change, the Agricultural Research Service of the United States Department of Agriculture asked the National Academy of Sciences (NAS) in late 1997 to 1) determine the scientific

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basis of an effective food safety system, 2) assess the effectiveness of the current food safety system in the United States, 3) identify scientific needs and gaps within the current system, and 4) provide recommendations on scientific and organizational changes in federal food safety activity needed to ensure an effective science-based food safety system. The Committee to Ensure Safe Food from Production to Consumption was formed by the Institute of Medicine (IOM) and National Research Council (NRC) to do the evaluation in response to this request. The committee reviewed mechanisms now in place at the federal level to ensure safe food, assessed the extent to which they are effective in addressing food safety issues from production to consumption, and developed recommendations about changes needed to move toward a more effective food safety system. This volume reports the deliberations, conclusions, and recommendations of the committee. The IOM and the NRC also formed an oversight commission composed of members from the Food and Nutrition Board, the Board on Agriculture, and the Board on Environmental Studies and Toxicology of the Commission on Life Sciences. The chair, Donald Kennedy, is a member of both IOM and of NAS. The role of the Commission was to nominate a committee whose expertise would be appropriately balanced for a study of this scope and complexity. The multidisciplinary group included experts in public health, epidemiology, food science, food microbiology, production agriculture, veterinary medicine, food technology, food regulatory law, consumer protection, consumer education, and media communications. In addition, five members of the 13 member committee held previous positions in federal agencies involved in food safety, three were from the food industry, and two from the agriculture/aquaculture industry. And, of course, all committee members are frequent consumers of food (see Appendix G for biographical sketches of each committee member). The committee held three meetings during its short period of deliberations. The first meeting, held March 23 to 25, 1998, included an open meeting to hear from the federal agencies most involved with food safety and from Dr. Ed Knipling, Associate Administrator of ARS/USDA who served as the project officer for the study. Representatives from each agency were asked to discuss the mission of their agency and its involvement in regulatory efforts, and to provide the agency budget for key activities related to food safety (see Appendix E). The second meeting, held April 28 to May 1, 1998, was held in conjunction with an open meeting to which individuals representing many of the major organizations with interests related to food safety presented their responses to three questions: 1)   What works well in the current US food safety system? 2)   What changes would lead to a more effective food safety system? 3)   What types of changes would be detrimental to an effective food safety system?

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A summary of the major points made by invited participants during the second workshop appears as Appendix D in the report. The final meeting of the committee, held June 12-14, 1998, did not include an open portion. At this meeting, the committee finished its major deliberations related to the report and finalized its recommendations. The Executive Summary presents the committee's principal findings and recommendations from its review of the four areas it was charged to consider. Chapter 1 provides an introduction to the issues and concerns related to food safety, including a brief history of food safety legislation since the early 1900's. Chapter 2 describes the current food safety system, with special attention to the federal role. Public health hazards resulting from the changing nature of pathogens and other toxicants are discussed in Chapter 3. Chapter 4 presents the committee's judgment regarding the attributes of a model food safety system. Chapter 5 compares the current federal system with the model system and identifies gaps. Chapter 6 includes the major conclusions and recommendations of the committee regarding changes needed in approaches and organizational structure to move toward a more effective food safety system. The appendices include reports and information related to the overall issues: Appendix A includes organizational charts, which identify the various components of the federal governments with functions related to food safety; Appendix B includes a recently released report from the Congressional Research Service outlining past recommendations for organizational change in food safety at the federal level; Appendix C includes the executive summary from Food Safety from Farm to Table: A National Food-Safety Initiative; Appendix D is a summary of points presented to the committee at their open meeting in April by representatives of various groups with interests in food safety, Appendix E includes information provided by federal agencies on levels of funding attributed to the major components of food safety for the years 1995-98, and Appendix F acknowledges the many individuals who assisted the committee by providing comments and materials in the information-gathering phase of the study. 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 NRC Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the IOM and the NRC in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The content of the final report is the responsibility of the IOM, NRC, and the study committee, and not the responsibility of the reviewers. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The Committee to Ensure Safe Food From Production to Consumption thanks the following individuals, who are neither officials nor employees of the IOM or the NRC, for their participation in the review of this report: Francis F. Busta, University of Minnesota; Lester Crawford, Georgetown University; Bernard D. Goldstein, UMDNJ-Robert Wood Johnson Medical School; Ray Hankes,

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Preferred Stock Genetic, Inc.; Carol Tucker Foreman, Foreman, Heiderpriem and Mager, Inc.; Cynthia M. Harris, Florida A&M University; Donald Hornig, Harvard University; Malden Nesheim, Cornell University; Stuart E. Richardson, California Department of Health Services; Mark Silbergeld, Consumers Union; and Bruce Stillings, Food & Agriculture Consultants. While the individuals listed above have provided many constructive comments and suggestions, it must be emphasized that responsibility for the final content of this report rests entirely with the authoring committee, the IOM, and the NRC. On behalf of the committee, it is a pleasure to thank Allison Yates, study director, senior staff officers Charlotte Kirk Baer and Sandra Schlicker, research associate Elisabeth Reese, IOM policy intern Kate Gorton, and project assistants Geraldine Kennedo and Melinda Simons. Their efforts were essential to the timely conclusion of our mission. Additionally, the committee thanks Michael Phillips for his assistance as director of the Board on Agriculture and Shirley Thatcher, his administrative assistant, and Norman Grossblatt of the Commission on Life Sciences for his valued editorial assistance early in the development of the report. We thank Michael A. Edington from the IOM Reports and Information Office for assistance in the production of the report and Claudia Carl, who managed the report review process. We also thank all who provided comments to the committee during the course of its deliberations. It is a pleasure also to record my personal thanks to the committee itself, which accomplished a prodigious amount of high-quality analysis and interpretation in a very short time. JOHN C. BAILAR III, CHAIR, COMMITTEE TO ENSURE SAFE FOOD FROM PRODUCTION TO CONSUMPTION

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Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION AND BACKGROUND   17     Changes in the US Food System and Their Effects on Food Safety   18     Scope of the Food Safety Problem   20     History of US Food Safety Regulation   21     The Committee and Its Charge   23 2   THE CURRENT US FOOD SAFETY SYSTEM   25     Regulation   26     Federal Regulatory Programs   26     State and Local Regulatory Systems   28     HACCP Systems   29     Voluntary Efforts   31     Liability   33     Surveillance   34     Human and Animal Disease   34     Chemical Residues and Environmental Contaminants   36     Technical Guidance and Education   38     Government Activities   38     Private Efforts   39     Consumer Responsibility and Perceptions   39

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    The Role of Media-Government Partnerships in Food Safety Education   42     Research and Development   43     Federal Research Activities   43     Application of New Technology   45     International Dimensions   46     Food Safety Efforts of Other Countries   46     US Regulation of Imported Foods   47     Summary Findings: The Current US System for Food Safety   49 3   THE CHANGING NATURE OF FOOD HAZARDS: CAUSE FOR INCREASING CONCERN   51     Changes that Affect the Epidemiology of Foodborne Disease   51     Diet   52     Commercial Food Service   54     Methods of Production and Distribution   54     New or Re-emerging Infectious Foodborne Agents   55     Populations at High Risk for Severe or Fatal Foodborne Disease   56     Changes in Chemical Hazards Associated with the Food Supply   57     New Food Components   58     New Food Technologies   59     New or Re-emerging Toxic Agents   59     Physical Hazards   60     Summary Findings: The Changing Nature of Food Hazards   61 4   WHAT CONSTITUTES AN EFFECTIVE FOOD SAFETY SYSTEM?   63     The Mission of the System   63     General Attributes of the System   65     The Importance of Partnering   67     The Roles of Government Partners   67     A Science-Based Foundation Using Risk Analysis   68     Adequate Surveillance and Monitoring   69     Focused Education and Research   69     Effective and Consistent Regulation and Enforcement   71     Response and Adaptation to New Technology and Changing Consumer Needs   71     Human and Financial Resources   72     The Roles of Private-Sector Partners   73     Producers   73     Processors, Marketers, and Distributors   74     The Role of the Consumer   75     The Role of Other Partners   76     A Dynamic Interdependence   77     Summary Findings: An Effective Food Safety System   78

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5   WHERE CURRENT US FOOD SAFETY ACTIVITIES FALL SHORT   79     Inadequate Application of Science   80     Research Funding Levels   81     Recent Efforts to Improve Research   82     Inadequate Use of Risk Assessment   82     Insufficient Information   83     HACCP Systems and Their Limitations   84     Absence of Focused Leadership   85     Statutory Limitations   85     Lack of Coordination   87     Deficiencies in Regulation of Imported Food   89     Summary Findings: Where the US Food Safety System Falls Short   90 6   CONCLUSIONS AND RECOMMENDATIONS   91     Scientific Recommendations   92     Rationale for Recommendations Related to a Science-Based System   95     Role of Risk Analysis   96     Resources Required for Research   96     Recommendations to Implement a Science-Based System Through Organizational Changes   97     Rationale for Organizational Recommendations   98     Centralized and Unified Federal Framework   98     Integration of Food Safety Efforts   99     REFERENCES   101     APPENDIXES   105     AGlossary and Organizational Framework for Current Food Safety System   105     BCRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997   115     CExecutive Summary: Food Safety From Farm to Table: A National Food-Safety Initiative   161     DSummary of Comments and Testimony from Workshop (April 29-30, 1998) and Agenda   169     EFederal Food Safety Budget Information   181     FAcknowledgments   185     GCommittee Biographical Sketches   189

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Ensuring Safe Food From Production to Consumption

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