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OCR for page R1
SCIENTIFIC CRITERIA
TO ENSURE SAFE FOOD
Committee on the Review of the Use of Scientific Criteria
and Performance Standards for Safe Food
Food and Nutrition Board
Board on Agriculture and Natural Resources
INSTITUTE OF MEDICINE
NATIONAL RESEARCH COUNCIL
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
OCR for page R2
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 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 Insti-
tute of Medicine. The members of the committee responsible for the report were chosen
for their special competences and with regard for appropriate balance.
Support for this project was provided by U.S. Department of Health and Human Services,
Food and Drug Administration, under contract number 223-01-2460, Task Order 6, and
the U.S. Department of Agriculture, Food Safety and Inspection Service, under contract
number FSIS-27-B-01. The views presented in this report are those of the Committee on
the Review of the Use of Scientific Criteria and Performance Standards for Safe Food and
are not necessarily those of the funding agencies.
Library of Congress Cataloging-in-Publication Data
Committee on the Review of the Use of Scientific Criteria and Performance
Standards for Safe Food.
Scientific criteria to ensure safe food / Committee on the Review of the Use of Scientific
Criteria and Performance Standards for Safe Food, Food and Nutrition Board, Board on
Agriculture and Natural Resources.
p. ; cm.
Includes bibliographical references.
ISBN 0-309-08928-X (hardcover), ISBN 0-309-50920-3 (PDF)
1. Food Safety measures 2. Food adulteration andinspection.
[DNLM: 1. Food Contamination prevention & control. 2. Food Microbiology. 3.
Food Supply standards. WA 701 S416 2003] I. Title.
TX531.C586 2003
363.19'26 dc22
2003015501
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, http://www.nap.edu.
For more information about the Institute of Medicine, visit the IOM home page at:
www.iom.edu.
Copyright 2003 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America.
OCR for page R3
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and 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. Bruce M. 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. Wm. 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 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. Harvey V. Fineberg 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. Bruce M. Alberts and Dr. Wm. A. Wulf are
chair and vice chair, respectively, of the National Research Council.
www. nationa l-academies.org
OCR for page R4
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, aniMedirine
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 ~ 863, the Academy has a mandate that requires it to advise the federal government on
scientific and technical matters. Dr. Bruce M. 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 Engineenng also sponsors
engineering programs aimed at meeting national needs, encourages education and research, and
recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National
Academy of Engineering.
The Institute of Medicine was established in ~ 970 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. Harvey V. Fineberg 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 sentences 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 M. Alberts and Dr. Wm. A. Wulf are chair and vice
chair, respectively, of the National Research Council.
www. national-academ ies~org
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COMMITTEE ON THE REVIEW OF THE USE OF SCIENTIFIC
CRITERIA AND PERFORMANCE STANDARDS FOR SAFE FOOD
CLAUDE EARL FOX (Co-chair), Urban Health Institute, Johns Hopkins
University, Baltimore, Maryland
CAMERON HACKNEY (Co-chair), Davis College of Agriculture, Forestry
and Consumer Sciences, West Virginia University, Morgantown
KATHRYN ,1. BOOR, Department of Food Science, Cornell University,
Ithaca, New York
ELIZABETH BOYLE, Department of Animal Sciences and Industry, Kansas
State University, Manhattan
MARSHA N. COHEN, Hastings College of the Law, University of California,
San Francisco
,IAMES S. DICKSON, Department of Microbiology, Iowa State University,
Ames
DARRELL W. DONAHUE, Department of Chemical and Biological
Engineering, University of Maine, Orono
JEFFREY M. FARBER, Bureau of Microbial Hazards, Health Products and
Food Branch, Food Directorate, Health Canada, Ottawa, Ontario
ROBERT GRAVANI, Department of Food Science, Cornell University,
Ithaca, New York
RICHARD L. GUERRANT, Division of Geographic and International
Medicine, Health Sciences Center, University of Virginia, Charlottesville
NEAL H. HOOKER, Department of Agricultural, Environmental and
Development Economics, The Ohio State University, Columbus
JOHN A. MARCY, Center of Excellence for Poultry Science, University of
Arkansas, Fayetteville
DONALD W. SCHAFFNER, Department of Food Science, Rutgers
University, New Brunswick, New Jersey
DONN R. WARD, Department of Food Science, North Carolina State
University, Raleigh
Consultants
THOMAS P. GRUMBLY, Keystone Center, Keystone, Colorado
I. GLENN MORRIS, JR., Department of Epidemiology and Preventative
Medicine, University of Maryland School of Medicine, Baltimore
ROBERT V. TAUXE, National Center for Infectious Diseases, Centers for
Disease Control and Prevention, Atlanta, Georgia
v
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SUBCOMMITTEE ON MEAT AND POULTRY
,IAMES S. DICKSON (Chair), Department of Microbiology, Iowa State
University, Ames
ELIZABETH BOYLE, Department of Animal Sciences and Industry, Kansas
State University, Manhattan
NEAL H. HOOKER, Department of Agricultural, Environmental and
Development Economics, The Ohio State University, Columbus
JOHN A. MARCY, Center of Excellence for Poultry Science, University of
Arkansas, Fayetteville
JIM E. RIVIERE, Center for Chemical Toxicology Research and
Pharmacokinetics, College of Veterinary Medicine, North Carolina State
University, Raleigh
JOHN G. SURAK, Department of Food Science and Nutrition, Clemson
University, Clemson, South Carolina
TERRI WENGER, Trade and Consumer Protection, Wisconsin Department of
Agriculture, Madison
SUBCOMMITTEE ON PRODUCE AND RELATED PRODUCTS,
SEAFOOD, AND DAIRY PRODUCTS
ROBERT GRAVANI (Chair), Department of Food Science, Cornell University,
Ithaca, New York
KATHRYN ,1. BOOR, Department of Food Science, Cornell University,
Ithaca, New York
DARRELL DONAHUE, Department of Chemical and Biological Engineering,
University of Maine, Orono
LINDA ,1. HARRIS, Department of Food Science and Technology, University
of California-Davis
CRAIG HEDBERG, Division of Environmental and Occupational Health.
University of Minnesota, Minneapolis
W. STEVEN OTWELL, Department of Food Science and Human Nutrition,
University of Florida, Gainesville
DONN R. WARD, Department of Food Science, North Carolina State
University, Raleigh
vim
OCR for page R7
Stay
RICARDO MOLINS, Study Director
MARIA ORIA, Program Officer
TAZIMA A. DAVIS, Research Assistant
SANAIT TESFAGIORGIS, Senior Prolect Assistant
GAIL E. SPEARS, Staff Editor
GARY WALKER, Financial Associate
-
. .
vat
OCR for page R8
FOOD AND NUTRITION BOARD
ROBERT M. RUSSELL (Vice-chair), U.S. Department of Agriculture Jean
Mayer Human Nutrition Research Center on Aging, Tufts University,
Boston, Massachusetts
LARRY R. BEUCHAT, Center for Food Safety, University of Georgia, Griffin
BENJAMIN CABALLERO, Center for Human Nutrition, Johns Hopkins
Bloomberg School of Public Health, Baltimore, Maryland
SHIRIKI KUMANYIKA, Center for Clinical Epidemiology and Biostatistics,
University of Pennsylvania School of Medicine, Philadelphia
LYNN PARKER, Child Nutrition Programs and Nutrition Policy, Food
Research and Action Center, Washington, D.C.
A. CATHARINE ROSS, Nutrition Department, Pennsylvania State
University, University Park
BARBARA O. SCHNEEMAN, Department of Nutrition, University of
California, Davis
STEVE L. TAYLOR, Department of Food Science and Technology and Food
Processing Center, University of Nebraska-Lincoln
CATHERINE E. WOTEKI, Department of Food Science and Human
Nutrition, Iowa State University, Ames
BARRY L. ZOUMAS, Department of Agricultural Economics and Rural
Sociology, Pennsylvania State University, University Park
Staff
ALLISON A. YATES, Director
LINDA D. MEYERS, Deputy Director
GAIL E. SPEARS, Staff Editor
GERALDINE KENNEDO, Administrative Assistant
GARY WALKER, Financial Associate
. . .
vail
OCR for page R9
BOARD ON AGRICULTURE AND NATURAL RESOURCES
MAY R. BERENBAUM (Chair), Entomology Department, University of
Illinois at Urbana-Champaign
SANDRA BARTHOLMEY, Crystal Lake, Illinois
DEBORAH BLUM, School of Journalism and Mass Communication,
University of Wisconsin, Madison
H.H. CHENG, Department of Soil, Water and Climate, University of Minnesota,
St. Paul
BARBARA P. GLENN, Federation of Animal Science Societies, Bethesda,
Maryland
LINDA F. GOLODNER, National Consumers League, Washington, D.C.
W.R. GOMES, Department of Agriculture and Natural Resources, University
of California, Oakland
PERRY R. HAGENSTEIN, Institute for Forest Analysis, Planning, and
Policy, Wayland, Massachusetts
JANET C. KING, U.S. Department of Agriculture Western Human Nutrition
Research Center, University of California, Davis
DAVID P. LOUCKS, Department of Civil and Environmental Engineering,
Cornell University, Ithaca, New York
WHITNEY MACMILLAN, Minneapolis, Minnesota
TERRY MEDLEY, Global Regulatory Affairs, DuPont Agriculture and
Nutrition, Wilmington, Delaware
OLE NIELSEN, Department of Ecosystem Health, Ontario Veterinary College,
Spruce Grove, Alberta
ALICE N. PELL, Department of Animal Science, Cornell University, Ithaca,
New York
BOBBY PHILLS, Land Grant Programs, Florida A&M University, Tallahassee
SHARON S. QUISENBERRY, College of Agriculture, Montana State
University, Bozeman
SONYA SALAMON, Department of Community and Rural Studies,
University of Illinois at Urbana-Champaign
G. EDWARD SCHUH, Humphrey Institute of Public Affairs, University of
Minnesota, Minneapolis
BRIAN ,1. STASKAWICZ, Department of Plant and Microbial Biology,
University of California, Berkeley
JACK WARD THOMAS, School of Forestry, University of Montana, Missoula
,IAMES H. TUMLINSON III, Agricultural Research Service, U.S. Department
of Agriculture, Gainesville, Florida
B.L. TURNER II, Graduate School of Geography, Clark University,
Worcester, Massachusetts
Six
OCR for page R10
Staff
CHARLOTTE KIRK BAER, Director
DONNA LEE ,IAMEISON, Administrative Assistant
OCR for page R11
Preface
Protecting public health by promoting food safety has long been recognized
as a state and federal responsibility. It has evolved through a series of legislative
acts that responded to the fact that a significant proportion of human illness and
deaths often have their genesis in the food supply. The U.S. Congress, concerned
about recurrent controversy regarding the scientific basis of food safety criteria in
regulating meat and poultry processing, commissioned the National Academies,
through the Food Safety Inspection Service of the U.S. Department of Agriculture
(USDA), to conduct the study that has resulted in this report. The study was to
emphasize, but not be limited to, microbiological criteria currently in use in the
meat and poultry industries.
Recognizing that the issues surrounding food safety criteria are common to
all sectors of the food industry, the National Academies invited the Food and
Drug Administration (FDA) to cosponsor the study. As a result, the scope of the
study includes food safety criteria currently in use in the processing of seafood,
produce and related products, and dairy products. An ad hoc committee appointed
by the National Academies to examine the relevant general issues of interest to
the USDA and FDA was charged with developing two reports, assisted by two
subcommittees, one on meat and poultry and a second one on seafood, produce
and related products, and dairy products. However, it was later agreed with the
sponsors than only one report would be produced. The committee was asked to
develop definitions for the terms "performance standard" and "criteria" and to
(1) evaluate the scientific basis for existing criteria, particularly microbiological
performance standards, applicable to the selected food groups, and the extent to
which these standards are appropriate means of ensuring the safety of such foods
x~
OCR for page R12
xt!
PREFACE
within a Hazard Analysis and Critical Control Point (HACCP)-based system;
(2) define the science-based process to establish food safety criteria and recom-
mend guidelines as to what data are adequate and appropriate for use in develop-
ing new, or modifying existing, criteria; (3) examine whether current criteria
accomplish what they purport to accomplish and the need to relate science-based
criteria to public health objectives; (4) review the need for performance standards
as measures of process control and the way such criteria are used under HACCP;
and (5) recommend changes for improvement. During its deliberations, the com-
mittee and subcommittees heard from consumer, industry, and government repre-
sentatives, and from interested individuals.
The National Academies appointed a committee comprised of 14 members
with expertise and background in HACCP, public health, epidemiology of food-
borne diseases, food regulatory processes, law, consumer perspective, food science,
food microbiology, statistics of process control, process engineering, risk assess-
ment of food contaminants, and microbial growth modeling. The composition
and size of this committee changed after the first meeting; representation from the
public health and regulatory areas was augmented. Several committee members
participated also in one of the two subcommittees, each composed of seven
members with expertise in processing of the food groups under study. The sub-
committee chairs worked closely with the committee co-chairs and, in a real
sense, the overall committee had four co-chairs. Despite the diversity of disci-
plines and backgrounds represented, very lively and often intense discussions
gave way to committee consensus quickly and readily.
To supplement its expertise and to gather information on specific issues
relevant to its charge, the committee conducted a workshop and held three open
sessions as part of three of the committee's six meetings. The committee is
grateful to the participants in the expert panel, Jorgen Schlundt, World Health
Organization; Robert Tauxe, Centers for Disease Control and Prevention; Carol
Tucker Foreman, Consumer Federation of America; Don L. Zink; Kaye Wachsmuth,
Food Safety Inspection Service (retired); Michael Taylor, Resources for the
Future; and Frank Busta, University of Minnesota. The committee' s appreciation
is also extended to the USDA and FDA staff that contributed information, par-
ticularly Robert Buchanan (FDA), Philip Derfler (USDA), Daniel Englejohn
(USDA), Elise Golan (USDA), and William Garthright (FDA). In addition, the
committee is grateful to Bruce Tompkin, International Commission on Microbio-
logical Specifications for Foods, for his presentation to the committee. Special
recognition is extended to the representatives of consumer groups, trade organi-
zations, and the general public who contributed valuable information or views
that greatly enhanced the committee's knowledge and perspective on the issues
under consideration.
The Executive Summary presents the recommendations and the principal
findings of the committee, as well as some of the main definitions developed or
adopted by the committee in response to the charge. Chapter 1 describes the
OCR for page R13
PREFACE
. . .
Xti!
historical development of food safety regulatory approaches in the United States;
Chapter 2 highlights the importance of foodborne disease surveillance and moni-
toring of microbial contaminants of food, both from a public health standpoint
and as measures of the effectiveness of food safety criteria; Chapter 3 describes a
science-based strategy for developing food safety criteria, including performance
standards, and the procedures for obtaining the best data to support this process.
It also discusses various food safety tools available to the regulatory agencies in
developing and implementing science-based food safety criteria, including con-
cepts for addressing the magnitude of the risk of foodborne illness and identify-
ing factors that control that risk, a novel approach to relate performance standards
to public health objectives, and the economics of food safety criteria, and pro-
vides recommendations for improvement. The discussion of each "tool" in the
report is limited by design to that which is relevant to food safety, recognizing
that some, such as statistical process control and the economic aspects of criteria,
not only may be foreign to many food processors and food safety regulators, but
are also methodologies that only recently are being brought into play in food
safety. The subcommittees, in turn, contributed sector-oriented perspectives to
the overall effort of the committee, examined relevant issues and criteria, and
made recommendations for improvement specific to the food groups under con-
sideration (Chapters 4 through 7~. The final chapter (Chapter 8) summarizes the
committee's findings and recommendations.
As the study progressed, several members left the committee for various
reasons. The committee thanks Emilio Esteban, who contributed his knowledge
and enthusiasm to this report, and to George Hardy, who was appointed to the
committee but could not join it. Similarly, the committee thanks Glenn Morris
and Thomas Grumbly, who changed their status from members to committee
consultants.
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 published report as sound as possible and to ensure
that the report meets institutional standards for objectivity, evidence, and respon-
siveness to the study charge. The review comments and draft manuscript remain
confidential to protect the integrity of the deliberative process. We wish to thank
the following individuals for their review of this report:
Bill Aimutis, Cargill, Inc.; Christopher G. Atchison, The University of Iowa;
Mindy Brashears, Texas Tech University; Dean 0. Cliver, University of Cali-
fornia, Davis; Donald E. Conner, Auburn University; P. Michael Davidson, The
University of Tennessee; Jeff Farrar, California Department of Health Services;
George J. Flick, Jr., Virginia Polytechnic Institute and State University; John
Floros, Pennsylvania State University; Carol Tucker Foreman, The Food Policy
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xlv
PREFACE
Institute, Consumer Federation of America; Linda Golodner, National Consumers
League; Richard L. Hall, Independent Consultant, Food Industry; Myron M.
Levine, The University of Maryland; Joseph M. Madden, Neogen Corporation;
Nancy J. Rachman, Food and Chemical Practice Exponents, Inc.; Joan Rose,
The University of South Florida; Robert E. Smith, R.E. Smith Consulting, Inc.;
John Sofos, Colorado State University; Ewen C.D. Todd, Michigan State Uni-
versity; Bruce R. Tompkin, Conagra Refrigerated Prepared Foods; Laurian
Unnevehr, The University of Illinois; and Kaye Wachsmuth, Independent
Consultant, Public Health Microbiology.
Although the reviewers listed above have provided many constructive com-
ments and suggestions, they were not asked to endorse the conclusions or recom-
mendations nor did they see the final draft of the report before its release. The
review of this report was overseen by Michael Doyle, University of Georgia, and
Ronald W. Estabrook, University of Texas Southwestern Medical Center.
Appointed by the National Research Council and 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 com-
ments were carefully considered. Responsibility for the final content of this report
rests entirely with the authoring committee and the institution.
The co-chairs of the main committee and the chairs of the subcommittee, on
behalf of the full committee, commend the staff for their excellence in support,
editing, and contributions. Ricardo Molins, study director, was an invaluable
resource to the committee members, bringing both a national and international
perspective to the process in addition to assisting in building consensus among
the committee members. The chairs also thank Maria Oria, program officer, for
helping the committee focus on the issues of concern and for her valuable sugges-
tions throughout the process. The committee is grateful to Tazima Davis, research
assistant, and Sanait Tesfagiorgis, senior project assistant, for their support and
dedication. The chairs would also like to acknowledge the helpful contributions
of Allison Yates, director of the Food and Nutrition Board, whose leadership
gave the committee the tools to build consensus on the issues, and of Charlotte
Kirk Baer, director of the Board on Agriculture and Natural Resources. This
report would not be possible were it not for the contributions of the staff and they
have our deepest appreciation.
It is with great satisfaction that we thank the committee, subcommittees, and
consultants for sharing with us their knowledge and efforts in accomplishing the
heavy task entrusted to us in a relatively short time and with an admirable display
of teamwork.
Claude Earl Fox, Cameron Hackney
Co-Chairs, Committee on the Review of the Use of Scientific
Criteria and Performance Standards for Safe Food
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Contents
PREFACE
ACRONYMS
EXECUTIVE SUMMARY
1 HISTORICAL PERSPECTIVE ON THE USE OF FOOD
SAFETY CRITERIA AND PERFORMANCE STANDARDS
The Impact of Changing Scientific and Societal Conditions on
Standards, 17
Fragmentation of the Current Regulatory System, 18
Development of New Regulatory Approaches, 20
References, 25
2 THE SCIENCE OF PUBLIC HEALTH SURVEILLANCE
The Tools of Public Health Surveillance, 28
Results from Public Health Surveillance, 37
Monitoring Hazards in the Food Chain, 47
Pathogenesis, 53
Use of Public Health Data to Improve Food Safety:
Specific Examples, 54
Anticipating the Future, 59
References, 60
xv
xi
xix
1
13
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xvi
3 FOOD SAFETY TOOLS
Hazard Analysis and Critical Control Points, 69
Risk Assessment, 73
Food Safety Objectives, 88
Strategies for Developing Criteria and Performance Standards, 101
Statistical Tools to Verify Process Stability and Capability, 107
The Economics of Food Safety Criteria, 116
The Impact of Changing Technology: New Diagnostic Tools, 125
The Limits of Science, 126
References, 128
4 SCIENTIFIC CRITERIA AND PERFORMANCE
STANDARDS TO CONTROL HAZARDS IN MEAT AND
POULTRY PRODUCTS
Description of the Meat and Poultry Industry, 133
Meat and Poultry Inspection, 136
Review of Current Standards for Meat and Poultry, 141
Application of Performance Standards Within the HACCP
System, 162
Economic Costs and Benefits of the PR/HACCP Rule, 165
The Need for Additional Approaches to Reduce Microbial
Hazards, 169
Do Meat and Poultry Performance Standards Improve Public
Health?, 173
References, 174
5 SCIENTIFIC CRITERIA AND PERFORMANCE
STANDARDS TO CONTROL HAZARDS IN SEAFOOD
Description of the Seafood Industry, 181
Review of Current Food Safety Criteria for Seafood, 183
References, 194
6 SCIENTIFIC CRITERIA AND PERFORMANCE
STANDARDS TO CONTROL HAZARDS IN PRODUCE
AND RELATED PRODUCTS
Fresh Fruits and Vegetables and Fresh-Cut Products, 197
Fruit and Vegetable Juices, 205
Low-Acid and Acidified Canned Foods, 211
Sprouts, 216
Pesticide Residues, 216
Food Defect Action Levels, 217
International Criteria, 218
CONTENTS
69
133
179
197
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CONTENTS
Do Produce and Juice Performance Standards Improve Public
Health?, 218
References, 220
SCIENTIFIC CRITERIA AND PERFORMANCE
STANDARDS TO CONTROL HAZARDS IN DAIRY
PRODUCTS
Milk, 226
Cheese and Other Dairy Food Products, 233
The Role of the U.S. Department of Agriculture in Dairy Product
Quality and Wholesomeness, 238
The Use of Current Standards and Criteria Under HACCP, 240
Are the Standards and Scientific Criteria for Milk and Dairy Products
Achieving Their Goal?, 241
Economic and Administrative Feasibility of Milk Pasteurization, 245
References, 245
8 OVERALL FINDINGS AND RECOMMENDATIONS
The Need for Regulatory Agencies to Have the Authority and
Flexibility to Enact, Enforce, and Update Food Safety Criteria, 249
Linking Food Safety Criteria to Public Health Objectives, 249
Developing and Monitoring Science-Based Food Safety Criteria, 251
HACCP, 251
Scientific Criteria in Meat and Poultry, Seafood, Produce, and Dairy
Products, 257
APPENDIXES
A Current and Proposed Definitions of Key Food Safety Terms
B Sanitation Performance Standards
C Food and Drug Administration and Environmental Protection Agency
Guidance Levels for Seafoods
D Food Defect Action Levels in Produce
E International Microbiological Criteria
F International Microbiological Criteria for Dairy Products
G U.S. Department of Agriculture Agricultural Marketing Service
Standards for Milk and Dairy Products
H Biographical Sketches of Committee and Subcommittee Members
INDEX
XVi1
225
248
273
294
303
309
317
359
366
370
379
OCR for page R18
FarmSO Farm Safety Objective
FSTS Food Safety Inspection Service (USDA)
FSO Food Safety Objective
HACCP Hazard Analysis and Critical Control Points
HHS U.S. Department of Health and Human Services
HIMP HACCP-Based Inspection Models Project
HTST High-Temperature Short-Time
ICMSF International Commission on Microbiological Specifications for Foods
IFPA International Fresh-Cut Produce Association
IFT Institute of Food Technologists
IMS Interstate Milk Shipper
ISSC Interstate Shellfish Sanitation Conference
TOM Institute of Medicine of the National Academies
ISSC Interstate Shellfish Sanitation Conference
JECFA FAD/WHO Joint Expert Committee on Food Additives
MCkG Maximum Contaminant Level Goal
MDP Microbiological Data Program
MRA Microbial Risk Assessment
MRL Maximum Residue Level
NACMCF National Advisory Committee on Microbiological Criteria for Foods
NFPA National Food Processors Association
NAHMS National Animal Health Monitoring System (USDA/APHTS)
NCIMS National Conference on Interstate Milk Shipments
NAS National Academy of Sciences
NELS New Enhanced Line Speed
NMFS National Marine Fisheries Service
NRC National Research Council
NOAEL No Observed Diverse Effect Level
OCP Other Consumer Protection (Defects)
OlG Office of Inspector General
PCR Polymerase Chain Reaction
PHS Public Health Service
PHT Post-harvest Treatment
PMO Grade A Pasteurized Milk Ordinance
PSO Processing Safety Objective
PR/HACCP Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) final
rule (published by FSIS in 1996)
QMRA Quantitative Microbial Risk Assessment
RA Risk Assessment
RIA Regulatory hop act Assessment
RT} Research Triangle Institute
RfD Reference Dose
RTE Ready-to-Eat (Foods)
RVIS Residue Violation Information System (FS1:S)
S ERA Salmonella Enteritidis Risk Assessment
SHA Seafood HACCP Alliance
. . .
xv
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Acronyms
ALOP Appropriate level of protection
AMS Agricultural Marketing Service
APC Aerobic plate count
APHIS Animal and Plant Health Inspection Service
BRFSS Behavioral Risk Factor Surveillance System
BSE Bovine spongiform encephalopathy
CAC Codex Alimentarius Commission
CCP Critical Control Point
CDC Centers for Disease Control and Prevention
CFR Code of Federal Regulations
CSPI Center for Science in the Public Interest
CVM Center for Veterinary Medicine
DMC Direct microscopic count
DNA Deoxyribonucleic acid
EPA U.S. Environmental Protection Agency
ETEC Enterotoxigenic Escherichia cold
FAO Food and Agriculture Organization of the United Nations
FarmSO Farm Safety Objective
FDA Food and Drug Administration
ax
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xx ACRONYMS
FSO Food Safety Objective
FSIS Food Safety and Inspection Service
GAO U.S. General Accounting Office
GAP Good Agricultural Practice
GHP Good Hygienic Practice
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
HACCP Hazard Analysis and Critical Control Point
HIMP HACCP-based Inspection Model Project
ICMSF International Commission on Microbiological Specifications fog
Foods
IFPA International Fresh-cut Produce Association
ISO International Organization for Standardization
ISSC Interstate Shellfish Sanitation Conference
JECFA FAD/WHO Joint Expert Committee on Food Additives
MEN Most probable number
mRNA Messenger ribonucleic acid
NACMCF National Advisory Committee on Microbiological Criteria for
Foods
NAHMS National Animal Health Monitoring System
NARMS National Antimicrobial Resistance Monitoring System
NASA National Aeronautics and Space Administration
NFSS National Food Safety System
NOAEL No-observed-adverse-effect level
NRC National Research Counci]
OCP Other consumer protection
PCR Polymerase chain reaction
PHS Public Health Service
PMO Grade A Pasteurized Milk Ordinance
PR/HACCP Pathogen Reduction; Hazard Analysis and Critical Control Point
Final Rule
PSO Processing Safety Objective
Quantitative microbial risk assessment
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ACRONYMS
RA
RTE
RTI
SCC
SERA
SPC
TSRO
USDA
VTEC
WHO
WTO
xx
Risk assessment
Ready-to-eat
Research Triangle Institute
Somatic cell count
Salmonella Enteritidis risk assessment
Statistical Process Control
Transportation and Retail Safety Objective
U.S. Department of Agriculture
Verotoxigenic Escherichia cold
World Health Organization
World Trade Organization
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