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Evaluation and
Definition of
Potentially
Hazardous
Foods
A Report of the Institute of Food Technologists
for the Food and Drug Administration
of the United States Department of Health and Human Services
December 31, 2001
IFT/FDA Contract No. 223-98-2333
Task Order No. 4
IFT/FDA Report on Task Order 4
Table of Contents
Preface ........................................................................................ 3 References .............................................................................41
ation Technologies and
Acknowledgments Chapter 5. Effect of Preserv
Science Advisory Board............................................................... 3 Microbiological Inactivation in Foods .................................42
Scientific and Technical Panel......................................................4 1. Introduction .......................................................................42
Reviewers ....................................................................................4 2. Validation of processing parameters ..................................42
Additional Acknowledgments .....................................................5 3. Processing technologies ....................................................42
IFT/FDA Task Order Charge 3.1 Water activity and pH...................................................42
Background ................................................................................. 6 3.2 Technologies based on thermal effects .........................42
Current Policy ..............................................................................6 3.3 High pressure processing.............................................43
Scope of Work.............................................................................7 3.4 Pulsed electric fields ....................................................44
Executive Summary..................................................................... 8 3.5 Irradiation ....................................................................44
Chapter 1. Introduction and Explanatory Notes ......................15 3.6 Other technologies.......................................................45
References .............................................................................16 References .............................................................................45
Chapter 2. Current and Proposed Definitions of “Potentially Chapter 6. Microbiological Challenge Testing ..........................46
Hazardous Foods” ...............................................................17 1. Introduction .......................................................................46
1. Regulations review .............................................................17 2. Selection of challenge organisms .......................................46
1.1 Food and Drug Administration .....................................17 3. Inoculum level ...................................................................47
1.2 United States Department of Agriculture (USDA) ..........17 4. Inoculum preparation and method of inoculation .............47
1.3 State Regulations ..........................................................17 5. Duration of the study .........................................................48
1.4 International Regulations..............................................18 6. Formulation factors and storage conditions .......................48
2. Critique of FDA’s “potentially hazardous foods” definition.18 7. Sample analysis .................................................................49
References .............................................................................19
8. Data interpretation .............................................................49
Chapter 3. Factors that Influence Microbial Growth ...............21
9. Pass/fail criteria...................................................................49
1. Introduction .......................................................................21 References .............................................................................50
2. Intrinsic factors...................................................................21
Chapter 7. Comparison of NSF and ABA Protocols to Determine
2.1 Moisture content ..........................................................21
Whether a Food Requires Time/Temperature for Safety .....51
2.2 pH and acidity .............................................................22 1. Introduction .......................................................................51
2.3 Nutrient content ...........................................................23
2. Consideration of process ...................................................51
2.4 Biological structure.......................................................24
3. Microorganisms.................................................................51
2.5 Redox potential ............................................................25
4. Pass/fail criteria...................................................................51
2.6 Naturally occurring and added antimicrobials .............25
5. Number of sampling times .................................................52
2.7 Competitive microflora.................................................27 6. Replication .........................................................................53
3. Extrinsic factors ..................................................................27
7. Oxidationreduction potential ...........................................53
3.1 Types of packaging/atmospheres ..................................27
8. Methodology .....................................................................53
3.2 Effect of time/temperature conditions on 9. Inoculum ...........................................................................54
microbial growth ...........................................................28
10. Duration of test ................................................................54
3.3 Storage/holding conditions ..........................................29
11. Product categories ...........................................................54
3.4 Processing steps...........................................................30
12. Summary .........................................................................54
4. Other factors ......................................................................31
References .............................................................................54
4.1 Intended enduse of product........................................31 Chapter 8. Framework Developed to Determine Whether Foods
4.2 Product history and traditional use ..............................31 Need Time/Temperature Control for Safety ........................55
4.3 Interactions of factors ...................................................31 1. Description of framework ..................................................55
References .............................................................................32 2. Framework .........................................................................57
Chapter 4. Analysis of Microbial Hazards Related to Time/ 3. Critique of framework. Application of framework to foods .57
Temperature Control of Foods for Safety............................33 Chapter 9 Summary and Future Needs ....................................63
1. Introduction .......................................................................33
Appendices
2. Meat and poultry products ................................................33
Appendix A. Development of the Definition of “Potentially
3. Fish and seafood products.................................................34
Hazardous Foods” ...............................................................65
4. Fruits and vegetables..........................................................35
Appendix B. Data from Industry and Trade Organizations ......66
5. Cereal and grains and related products .............................36 Appendix C. Scientific Data Used to Develop the
6. Fats, oils, and salad dressings.............................................37 Framework ...........................................................................76
7. Butter and margarine..........................................................37
Appendix D. Industry Protocol for Establishing the Shelf
8. Sugars and syrups..............................................................38 Stability of Pumpkin Pie American Bakers Association ........78
9. Eggs and egg products .......................................................38
Appendix E. NonPotentially Hazardous Foods: American
10. Milk and milk products (except cheeses) .........................39
National Standard/NSF International Standard ...................82
11. Cheeses ...........................................................................39 List of References................................................................... 108
12. Combination products.....................................................40
2 COMPREHENSIVE REVIEWS IN FOOD SCIENCE AND FOOD SAFETY—Vol. 2, 2003
Preface
On September 30, 1998, the Food and Drug Administration (FDA) analysis. The panel met in person and via conference calls
of the U.S. Department of Health and Human Services signed a throughout the year 2000. IFT also assembled a Science Advisory
fiveyear contract with the Institute of Food Technologists (IFT) to Board to advise IFT on the FDA contract and on the individual
provide scientific review and analysis of issues in food safety, task orders.
food processing, and human health. Under the terms of the con
tract, FDA assigns IFT task orders, categorized as comprehensive The Institute of Food Technologists greatly appreciates the ef
or abbreviated reviews. IFT assembles Scientific and Technical forts of the Scientific and Technical Panels, the Science Advisory
Panels comprised of experts in the topic area to address the is Board, the many reviewers, staff and others who made this report
sues. The panels are charged with providing scientific and techni possible. Compensation for such an effort pales in comparison to
cal review and analysis, not with setting policy. the time, effort and expertise expended.
This report is IFT’s response to Task Order No. 4: Analysis and IFT is especially grateful to the FDA staff for their tremendous
Definition of Potentially Hazardous Foods. The Background and cooperation, communication, and assistance at every stage of this
Scope of Work that FDA provided to IFT are included. In October project. IFT submits this report to the Agency to contribute to the
2000, IFT assembled a Scientific and Technical Panel. This panel assessment and development of an operational sciencebased
was comprised of experts in food safety and microbiology, includ system to address foods that may require time/temperature control
ing safety in food retail, food service, regulatory affairs, and risk for safety reasons.
Science Advisory Board
Roy G. Arnold, Ph.D. Sanford A. Miller, Ph.D.
Executive Associate Dean Adjunct Professor
College of Agricultural Science Center for Food and Nutrition Policy
Oregon State University Virginia Polytechnic Institute and State University
Lester M. Crawford, Ph.D., D.V.M. Martha Rhodes Roberts, Ph.D.
Director Deputy Commissioner for Food Safety
Center for Food and Nutrition Policy Dept. of Agriculture
Virginia Polytechnic Institute and State University and Consumer Services State of Florida
Ray A. Goldberg G. Edward Schuh, Ph.D.
George M. Moffett Professor of Agriculture Freeman Chair Professor
and Business Emeritus Hubert H. Humphrey Institute of Public Affairs
Harvard Business School University of Minnesota
Marcus Karel, Ph.D. Barbara O. Schneeman, Ph.D.
Professor Emeritus Professor of Nutrition
Massachusetts Institute of Technology Department of Nutrition
and Rutgers University University of California
Vol. 2, 2003—COMPREHENSIVE REVIEWS IN FOOD SCIENCE AND FOOD SAFETY 3
IFT/FDA Report on Task Order 4
Institute of Food Technologists
Scientific and Technical Panel
Frank F. Busta, Ph.D. Gale Prince
Panel Chair and Senior Science Advisor The Kroger Company
to the Institute of Food Technologists
University of Minnesota . Schaffner, Ph.D.
Donald W
Cook College Rutgers
Dane T. Bernard, Ph.D. The State University of New Jersey
Keystone Foods
Katherine M.J. Swanson, Ph.D.
Robert B. Gravani, Ph.D. The Pillsbury Company
Cornell University
Betsy Woodward
Paul Hall Food Labs for Florida Department of Agriculture
Kraft Foods, Inc. and Consumer Services (Retired Chief)
Merle D. Pierson, Ph.D. Frank Yiannas
Virginia Polytechnic Institute Food Safety and Health
and State University Walt Disney World
Reviewers
Catherine Adams, Ph.D. Bestfoods Baking Company
Heinz North America
Leon Gorris
Michael H. Brodsky Uniliver
Brodsky Consultants
Maureen Olewnik
Alfred E. Bugenhagen American Institute of Baking
New York Department
of Agriculture and Markets Virginia N. Scott
National Food Processors Association
Martin Cole
Food Australia John Silliker, Ph.D.
Silliker Labs, Inc.
J. Joseph Corby
New York State Department George Smith
of Agriculture and Markets Arkansas Department of Health
Carl S. Custer Pete Snyder
U.S. Dept. of Agriculture Hospitality Institute of Technology
and Management
Michael P. Davidson, Ph.D.
University of Tennessee Dan Sowards
Texas Department of Health
Robert Donofrio Food Safety
NSF International
William H. Sperber
Michael P. Doyle, Ph.D. Cargill, Inc.
University of Georgia
Bruce Tompkin
Russell S. Flowers, Ph.D. Armour SwiftEckrich
Silliker Labs Group, Inc.
Edmund A. Zottola, Ph.D.
Leonard Wm. Heflich University of Minnesota
4 COMPREHENSIVE REVIEWS IN FOOD SCIENCE AND FOOD SAFETY—Vol. 2, 2003
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