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OCR for page R1
An Evaluation of
the Role of
Microbiological Criteria
for Foods and
Food Ingre(lients
Subcommittee on Microbiological Criteria
Committee on Food Protection
Food and Nutrition Board
National Research Council
NATIONAL ACADEMY PRESS
Washington, D.C. 1985
OCR for page R2
NATIONAL ACADEMY PRESS · 2101 CONSTITUTION AVENUE, NW · 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.
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 Research Council was established 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 of advising the federal government. The Council operates in accordance
with general policies determined by the Academy under the authority of its congressional charter
of 1863, which established the Academy as a private, nonprofit, self-governing membership
corporation. The Council has become the principal operating agency for both the National
Academy of Sciences and the National Academy of Engineering in the conduct of their services
to the government, the public, and the scientific and engineering communities. It is administered
jointly by both Academies and the Institute of Medicine. The National Academy of Engineering
and the Institute of Medicine were established in 1964 and 1970, respectively, under the charter
of the National Academy of Sciences.
The work on which this publication is based was performed pursuant to Contract No. Na80
GA-C-0060 from the Food and Drug Administration, the Department of the U.S. Army Natick
Research and Development Center, the U.S. Department of Agriculture, and the National Marine
Fisheries Service of the Department of Commerce, which served as administrator of the contract.
Library of Congress Cataloging in Publication Data
National Research Council (U.S.). Food Protection
Committee. Subcommittee on Microbiological
Criteria.
An evaluation of the role of
microbiological criteria for foods
and food ingredients.
Includes bibliographies and index.
1. Food Microbiology Congresses. 2. Food
poisoning Congresses. I. Title.
QRl l5.N37 1985 664'.028 84-25555
ISBN 0-309-03497-3
Copyright C) 1985 by the National Academy of Sciences
No part of this book may be reproduced by any mechanical, photographic, or electronic process,
or in the form of a phonograph 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 purposes of official use by the United States government.
Printed in the United States of America
First Printing, May 1985
Second Printing, May 1988
Third Printing, October 1988
Fours Printing, September 1990
OCR for page R3
Subcommittee on Microbiological Criteria
for Foods and Food Ingredients
CARL VANDERZANT, Department of Animal Science, Texas
Agricultural Experiment Station, Texas A&M University, College
Station, Chairman
DON F. SPLITTSTOESSER, Department of Food Science and
Technology, Agricultural Experiment Station, Cornell University,
Geneva, New York, Vice-Chairman
DAVID H. ASHTON, Hunt-Wesson Foods, Fullerton, California
FRANK L. BRYAN, Centers for Disease Control, Atlanta, Georgia
DAVID L. COLLINS-THOMPSON, Department of Environmental Biology,
Ontario Agricultural College, University of Guelph, Guelph, Ontario,
Canada
EDWIN M. FOSTER, Food Research Institute, University of Wisconsin,
Madison
JAMES J. JEZESKI, Department of Food Science and Nutrition,
University of Florida, Gainesville
RICHARD V. LECHOWICH, Technical Center, General Foods,
Tarrytown, New York
RUSSELL J. MARINO, Corporate Quality Assurance, Ralston Purina
Company, St. Louis, Missouri
JOSEPH C. OLSON, JR., Sun City Center, Florida
JOHN H. SILLIKER, Silliker Laboratories, Carson, California
MARGARET R. STEWART, Blacksburg, Virginia, Staff Officer
Committee on Food Protection
DON F. SPLITTSTOESSER, Department of Food Science and
Technology, Agricultural Experiment Station, Cornell University,
Geneva, New York, Chairman
ANDREW G. EBERT, Pet, Inc., St. Louis, Missouri
FREDERICK J. FRANCIS, Department of Food Science and Nutrition,
University of Massachusetts, Amherst
JESSE F. GREGORY, III, Department of Food Science and Human
Nutrition, IFAS, University of Florida, Gainesville
ALBERT C. KOLB YE, The Nutrition Foundation, Inc., Washington,
D.C.
DAVID R. LINEBACK, North Carolina State University, Department of
Food Science, Raleigh, North Carolina
RUSSELL J. MARINO, Corporate Quality Assurance, Ralston Purina
Company, St. Louis, Missouri
. . .
OCR for page R4
RICHARD A. SCANLAN, Department of Food Science and Technology,
Oregon State University, Corvallis, Oregon
STEPHEN L. TAYLOR, Food Research Institute, University of
Wisconsin, Madison
ROBERT A. MATHEWS, Staff Officer
Food and Nutrition Board
KURT J. ISSELBACHER, Chairman, Massachusetts General Hospital,
Boston
RICHARD L. HALL, Vice-Chairman, Science and Technology,
McCormick and Company, Hunt Valley, Maryland
HAMISH N. MUNRO, Vice-Chairman, Human Nutrition Research Center
on Aging, Tufts University, Boston, Massachusetts
WILLIAM E. CONNOR, Department of Medicine, Oregon Health Science
University, Portland
PETER GREENWALD, Division of Cancer Prevention and Control,
National Cancer Institute, National Institutes of Health, Bethesda,
Maryland
JOAN D. GUSSOW, Department of Nutrition Education, Teachers
College, Columbia University, New York, New York
RICHARD J. HAVEL, Cardiovascular Research Institute, University of
California School of Medicine, San Francisco, California
VICTOR HERBERT, Department of Medicine, Hahnemann University
School of Medicine, Philadelphia, Pennsylvania
JAMES R. KIRK, Campbell Soup Company, Camden, New Jersey
REYNALDO MARTORELL, Food Research Institute, Stanford University,
Stanford, California
J. MICHAEL McGINNIS, Office of Disease Prevention and Health
Promotion, Department of Health and Human Services, Washington,
D.C.
MALDEN C. NESHEIM, Division of Nutritional Sciences, Cornell
University, Ithaca, New York
ROBERT H. WASSERMAN, New York State College of Veterinary
Medicine, Cornell University, Ithaca, New York
MYRON WINICK, College of Physicians and Surgeons, Columbia
University, New York, New York
SUSHMA PALMER, Executive Director, National Research Council,
Washington, D.C.
1V
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Foreword
Over the last 20 years interest in and controversy over the application
of microbiological criteria to classify foods as either microbiologically
acceptable or microbiologically unacceptable have grown steadily. A 1964
report of the National Research Council, An Evaluation of Public Health
Hazards from Microbiological Contamination of Foods made some early
recommendations toward establishment of meaningful microbiological
criteria.
In recent years food industry groups at the national and international
levels have expressed concern that microbiological criteria for foods es-
tablished by regulatory agencies often were not based on sound principles
and for some foods were set without justifiable rationale. Regulatory
agencies charged with enforcement of laws and regulations on safety and
quality of foods must evaluate a myriad of complex production, process-
ing, and distribution practices and must frequently do so with limited staff
and an extremely tight budget. Microbiological criteria often provide a
definitive figure on which a decision to classify a food as being micro-
biologically acceptable or unacceptable can be based.
When microbiological criteria for foods are not based on definite needs,
sound principles, and statistically solid background information, they may
become a burden to the food industry, give a false sense of security to
the public and lessen confidence in the ability of regulatory agencies to
regulate the food supply.
Lack of sound guiding principles for the establishment of microbio-
logical criteria has, at least in part, been responsible for the large number
of standards and guidelines (particularly at the state and local level) that
are impractical, unenforceable, and without uniformity.
v
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V1
FOREWORD
For these reasons, the National Research Council through a subcom-
mittee of the Food and Nutrition Board's Committee on Food Protection
initiated in 1980 a study to formulate general principles for the consid-
eration and application of microbiological criteria for foods and food
ingredients and to provide recommendations for a unified, coordinated
approach. The study was to include (1) definitions, purposes, priorities,
and evaluation of methods for microbiological criteria; (2) recommendations
for sampling plans, collection locations, and interpretation of analytical
results; and (3) evaluation of existing or proposed international and federal
programs.
The subcommittee has sought the advice and counsel of representatives
of the sponsoring agencies: the Food and Drug Administration, the U.S.
Department of Agriculture, the National Marine Fisheries Service, and
the U.S. Army Natick Research and Development Center. Meetings were
held with members of the Food and Nutrition Board's Industry Liaison
Panel and representatives of the Centers for Disease Control, the Canadian
Bureau of Microbiological Hazards, and 15 industry and public health
groups. The subcommittee has benefited from the assistance and advice
of many colleagues in industry, government, and academia. The contri-
bution of all these groups is gratefully acknowledged.
In this book, the subcommittee has tried to set forth the principles for
establishment of meaningful microbiological criteria. Recommendations
are given on the need for microbiological criteria for 22 "commodity"
groups. In addition, plans of action are presented for implementation of
the Hazard Analysis Critical Control Point (HACCP) system and of mi-
crobiological criteria for foods and food ingredients.
OCR for page R7
Acknowledgments
The Subcommittee on Microbiological Criteria for Foods and Food
Ingredients wishes to acknowledge the valuable assistance of the following
individuals on the staffs of the contracting agencies:
E. Spencer Garrett, National Marine Fisheries Service of the Department
of Commerce, Project Officer for the study
R. B. Read, Jr., J. David Clem, Howard J. Pippin, Barry Wentz, Robert
Weik, Robert Sanders, and Garrett Higginbotham of the Food and Drug
Administration of the Department of Health and Human Services
Ralph W. Johnston, T. R. Murtishaw, W. H. Dubbert, Gerald Parlett,
Eddie F. Kimbrell, George Fry, and Richard Webber of the Department
of Agriculture
Durwood B. Rowley, Edmund Powers, and Gerald Silverman of the
U.S. Army Natick Research and Development Center of the Department
of the Army
The subcommittee also wishes to acknowledge the assistance and advice
of the following individuals in the development of its report:
O. Brian Allen, Department of Mathematics and Statistics, University
of Guelph, Ontario, Canada
Bruce Brown, Health Protection Branch, Health & Welfare, Canada
D. S. Clark, Bureau of Microbiological Hazards, Health Protection
Branch, Health & Welfare, Canada
Donald A. Corlett, Jr., Corporate Quality Assurance, Del Monte Cor-
poration, San Francisco, California
F. A. Gardner, Department of Poultry Science, Texas A&M University,
College Station
. .
V11
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V111
ACKNOWLEDGMENTS
Keith A. Ito, National Food Processors Association, Concord, Cali
~ .
rornla
G. Jarvis, Health Protection Branch, Health and Welfare, Canada
D. C. Kilsby, Unilever Research Laboratory, Colworth House, Sharn-
brook, Bedford, United Kingdom
R. Nickelson, II, Seafood Technology Section, Department of Animal
Science, Texas A&M University, College Station
A. Peterson, Campbell Soup Company, Camden, New Jersey
H. Michael Wehr, Oregon State Department of Agriculture, Salem
Roy Widdus, Institute of Medicine, Washington, D.C.
OCR for page R9
Contents
Executive Summary .
Introduction, 2
Basic Considerations, 3
Application of Microbiological Criteria to Foods
and Food Ingredients, 6
Expansion of the HACCP System in Food Protection
Programs, 13
Plans of Action, 14
Recommendations
· · ~
1 Introduction ...................
Sources of Microorganisms in Foocis, 41
Microbial Activities in Foods, 41
· ·
·
Historical Aspects, 41
Spoilage, Pathogenic, and Useful Microorganisms, 42
Food as a Selective Environment, 43
Microflora of Processed Foods, 44
Control of Microorganisms in Foods, 46
Approaches to Microbiological Control in Foods, 48
Education and Training Programs, 48
Inspection of Facilities and Operations, 48
Microbiological Testing, 50
Composite Programs, 50
The Hazard Analysis Critical Control Point (HACCP)
System, 50
1X
.. 15
. 41
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x
CONTENTS
The Current Role of Criteria in Microbiological Control in
Foods, 51
Considerations in Establishing Criteria, 53
The Current Report, 54
References, 54
2 Definitions, Purposes, and Needs for Microbiological
Criteria . . . . . . . . . . . . . . . . . . e · · · · · e · e ·
Definitions, 55
Components of a Microbiological Criterion, 55
Mandatory and Advisory Criteria, 56
Types of Microbiological Criteria, 56
Standard, 56; Guideline, 56; Specification, 57
Purposes, 57
Need for Establishment, 58
Applications of Criteria, 59
Standards, 59; Guidelines, 59; Specifications, 60
Relationship to Codex, 60
Attributes of Quality Amenable to Measurement by
Microbiological Criteria, 61
References, 64
3 Selection of Foods for Criteria Related to Safety
Epi(lemiological Experience, 66
Opportunities for Contamination, 67
Opportunities for Growth, 67
Opportunities for Survival, 69
Processing Conditions, 69
Susceptibility of Probable Consumers, 70
Ultimate Treatment, 70
References, 70
55
..... 65
4 Selection of Pathogens as Components of Microbiological
Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Introduction, 72
Pathogens, 73
Severe Hazards, 78
Clostridium botulinum, 78; Shigella, 79; Vibrio cholerae,
80; Salmonella, 81; Brucella abortus, Brucella melitensis,
72
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CONTENTS
X1
Brucella suds, and Mycobacterium bovis, 81; Viruses, 82;
Fish and shellfish toxins, 83; Mycotoxins, 84
Moderate Hazards, Potentially Extensive Spread, 85
Salmonella, 85; Pathogenic Escherichia cold (PEC), 87;
Streptococcus pyogenes (Lancefield Group A, beta
hemolytic), 87
Moderate Hazards, Limited Spread, 88
Staphylococcus aureus, 88; Clostridium perfringens, 89;
Bacillus cereus, 90; Vibrio parahaemolyticus, 91; Coxiella
burnetii, 91; Histamine poisoning, 92; Yersinia
enterocolitica, 93 Campylobacter, 94; Trichinella spiralis,
95
References, 96
5 Selection of Indicator Organisms and Agents as Components
of Microbiological Criteria 104
Assessment of Numbers of Microorganisms and/or
Microbial Activity, 105
Estimating Numbers of Microorganisms, 105
Aerobic Plate Count, 105; Thermoduric, Psychrotrophic,
Thermophilic, Proteolytic, and Lipolytic Counts, 107;
Direct Microscopic Count, 108; Microscopic Mold Counts,
109; Yeast and Mold Counts, 110; Heat-resistant Molds,
1 10; Thermophilic Spore Count, 1 10
Measuring Metabolic Products, 1 1 1
Organoleptic Examination, 1 1 1; Dye or Indicator
Reduction Time, 1 13; pH, 1 13; Trimethylamine and Total
Volatile Nitrogen, 1 16; Indole, 1 17; Ethanol, 1 18;
Diacetyl, 1 18; Histamine, 1 19; Limulus Amoebocyte
Lysate Test, 119; Extract Release Volume, 120; Adenosine
Triphosphate, 120
Assessment of Inclicators, 120
Indicators of Potential Human or Fecal Contamination
or Possible Presence of Pathogens, 120
Staphylococci, 120; Escherichia coli, 121; Fecal
Coliforms, 122; Enterococci, 123; Pseudomonas
aeruginosa, 124
Indicators of Post-Heat Processing Contamination, 124
Coliform Bacteria, 124; Enterobacteriaceae, 125
Tests for Other Components, 126
Tests for Metabolic Products of Pathogens That Indicate
a Health Hazard, 126
Thermonuclease Test for Evidence of Growth of
Staphylococci and Presence of Enterotoxins, 126; Aflatoxin
Detection by Ultraviolet Light, 126
Test for Phosphatase, 127
References, 127
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. .
X11
CONTENTS
6 Consideration of Sampling Associated With a
Criterion . ~ . . . . ~ . . ~ . . . . . ~ . ~ . . . . ~ . . . .
2-CIass Attributes Sampling Plans, 134
3-CIass Attributes Sampling Plans, 136
Variables Sampling Plans, 136
Operating Characteristic Curves, 137
Establishing Limits, 140
Resampling, 141
Applications, 142
References, 143
132
7 Consideration of Decision (Action) to be Taken When a
Criterion (Limit) is Exceeded 145
Decision Categories, 146
Evidence of Existence of a Direct Health Hazard, 146
Evidence That a Direct Health Hazard Could
Develop, 148
Indications That a Product Was Not Produced Under
Conditions Assuring Safety, 148
Indications That a Raw Material May Adversely Affect
Shelf-Life, 149
Evidence That a Critical Control Point Is Not Under
Control, 149
References, 150
Current Status of Microbiological Criteria and Legislative
Bases . . . . a · ~ · · · · ~ · · ~ ~
Introduction, 152
Early Programs in the United States, 152
Current Levels of Concern and Application, 153
International Activities, 154
Joint FAD/WHO Food Standards Program, 154
European Economic Community, 156
International Commission on Microbiological
Specifications for Foods (ICMSF), 157
Canadian Microbiological Standards for Foods, 157
U.S. Federal Agencies, 158
Food and Drug Administration (FDA), 158
Compliance Policy Guides, 159; Food Defect Action
Levels, 159; Efforts for Microbiological Standards, 163;
Cooperative Programs, 164
. 152
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CONTENTS
United States Department of Agriculture (USDA), 166
Dairy Products, 167; Dry Milk Products, 167; Egg
Products, 168; Meat and Poultry Products, 168
National Marine Fisheries Service (NMFS), 174
History, 174; Current Cooperative Agreements, 175;
Research, 176
U.S. Army Natick Research and Development
Center, 176
Federal and Regional Level Cooperation, 178
State Level, 178
City-County (Local) Level, 179
Industry, 180
References, 181
9 Application of Microbiological Criteria to Foods and Food
Ingredients . . . . . . . . . . . . . . . . . . . . . . .
Introduction, 184
Dairy Products, 185
Raw Meats, 193
Processed Meats, 199
Raw (Eviscerated, Ready-To-Cook) Poultry, 221
Processed Poultry Products, 230
Eggs and Egg Products, 239
Fish, Molluscs, and Crustaceans, 249
Fruits and Vegetables, 257
Fruit Beverages, 261
Low-Acid Canned Foods, 264
Acid Canned Foods, 268
Water Activity-Controlled Canned Foods, 270
Cereals and Cereal Products, 272
Fats and Oils, 277
Sugar, Cocoa, Chocolate, and Confectioneries, 283
Spices, 287
Yeasts, 289
Formulated Foods, 290
Nuts, 295
Miscellaneous Additives, 297
Bottled Water, Processing Water, and Ice, 299
Pet Foods, 304
. . .
x~
... 184
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XIV
10 Expansion of the HACCP System in Food Protection
Programs . 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
Factors to be Considered For Implementation of
HACCP, 308
Problems Associated with Implementation of the
HACCP Approach, 311
The Need For Application of HACCP at All Points in
the Foot! Chain, 313
Cost/Benefit Aspects of Regulatory Control Through
HACCP Inspections, 327
References, 327
CONTENTS
e 308
11 Plans of Action for Implementation of the HACCP System
and of Microbiological Criteria for Foods and Food
Ingredients e e e e e e e e e e e e e e e e e e e
Implementation of HACCP, 329
Implementation of Microbiological Criteria For Foods and
Food Ingredients, 330
Introduction, 330
The Plan, 333
References, 335
Appendixes e e e e e e e e e
A Summary Responses to Specific Contract Items, 339
B General Principles for the Establishment and Application of
Microbiological Criteria for Foods, 366
C International Microbiological Specifications, 372
D Excerpts from the Regulations Pursuant to the Food and Drugs
Act, a Statute of the Government of Canada, 377
E Microbiological Criteria for Foods Purchased by the Military,
387
F Raw Milk-An Editorial, 395
G Report of the WHO/ICMSF Meeting on Hazard Analysis:
Critical Control Point System in Food Hygiene, 399
.
e 329
e e 337
Index e e e
e e
e 421
OCR for page R15
An Evaluation of
the Role of
Microbiological Criteria
for Foods and
Foo(l Ingre(iients
OCR for page R16
