Evaluation and Definition of Potentially Hazardous Foods

Table of Contents

1. Preface
2. Acknowledgments
   1. Science Advisory Board
   2. Scientific and Technical Panel
   3. Reviewers
   4. Additional Acknowledgments
3. IFT/FDA Task Order Charge
   1. Background
   2. Current Policy
   3. Scope of Work
   4. Executive Summary
4. Chapter 1. Introduction and Explanatory Notes
   1. References
5. Chapter 2. Current and Proposed Definitions of "Potentially Hazardous Foods"
   1. 1. Regulations review
      1. 1.1 Food and Drug Administration
      2. 1.2 United States Department of Agriculture (USDA)
      3. 1.3 State Regulations
      4. 1.4 International Regulations
   2. 2. Critique of FDA's "potentially hazardous foods" definition
   3. References
6. Chapter 3. Factors that Influence Microbial Growth
   1. 1. Introduction
   2. 2. Intrinsic factors
      1. 2.1 Moisture content
      2. 2.2 pH and acidity
      3. 2.3 Nutrient content
      4. 2.4 Biological structure
      5. 2.5 Redox potential
      6. 2.6 Naturally occurring and added antimicrobials
      7. 2.7 Competitive microflora
   3. 3. Extrinsic factors
      1. 3.1 Types of packaging/atmospheres
      2. 3.2 Effect of time/temperature conditions on microbial growth
      3. 3.3 Storage/holding conditions
      4. 3.4 Processing steps
   4. 4. Other factors
      1. 4.1 Intended end-use of product
      2. 4.2 Product history and traditional use
      3. 4.3 Interactions of factors
   5. References
7. Chapter 4. Analysis of Microbial Hazards Related to Time/Temperature Control of Foods for Safety
   1. 1. Introduction
   2. 2. Meat and poultry products
   3. 3. Fish and seafood products
   4. 4. Fruits and vegetables
   5. 5. Cereal and grains and related products
   6. 6. Fats, oils, and salad dressings
   7. 7. Butter and margarine
   8. 8. Sugars and syrups
   9. 9. Eggs and egg products
   10. 10. Milk and milk products (except cheeses)
   11. 11. Cheeses
   12. 12. Combination products
   13. References
8. Chapter 5. Effect of Preservation Technologies and Microbiological Inactivation in Foods
   1. 1. Introduction
   2. 2. Validation of processing parameters
   3. 3. Processing technologies
      1. 3.1 Water activity and pH
      2. 3.2 Technologies based on thermal effects
      3. 3.3 High pressure processing
      4. 3.4 Pulsed electric fields
      5. 3.5 Irradiation
      6. 3.6 Other technologies
   4. References
9. Chapter 6. Microbiological Challenge Testing
   1. 1. Introduction
   2. 2. Selection of challenge organisms
   3. 3. Inoculum level
   4. 4. Inoculum preparation and method of inoculation
   5. 5. Duration of the study
   6. 6. Formulation factors and storage conditions
   7. 7. Sample analysis
   8. 8. Data interpretation
   9. 9. Pass/Fail criteria
   10. References
10. Chapter 7. Comparison of NSF and ABA Protocols to Determine Whether a Food Requires Time/Temperature for Safety
    1. 1. Introduction
    2. 2. Consideration of process
    3. 3. Microorganisms
    4. 4. Pass/fail criteria
    5. 5. Number of sampling times
    6. 6. Replication
    7. 7. Oxidation-reduction potential
    8. 8. Methodology
    9. 9. Inoculum position
    10. 10. Duration of test
    11. 11. Product categories
    12. 12. Summary
    13. References
11. Chapter 8. Framework Developed to Determine Whether Foods Need Time/Temperature Control for Safety
    1. 1. Description of framework
    2. 2. Framework
    3. 3. Critique of framework. Application of framework to foods
    1. Chapter 9 Summary and Future Needs
12. Appendices
    1. Appendix A. Development of the Definition of "Potentially Hazardous Foods"
    2. Appendix B. Data from Industry and Trade Organizations
    3. Appendix B. Data from Industry and Trade Organizations - Pass/Fail Criteria
    4. Appendix B. Data from Industry and Trade Organizations - Challenge Studies
    5. Appendix C. Scientific Data Used to Develop the Framework
    6. Appendix D. Industry Protocol for Establishing the Shelf Stability of Pumpkin Pie American Bakers Association
    7. Appendix E. Non-Potentially Hazardous Foods
       1. American National Standard/NSF International Standard
    8. List of References

A Report of the Institute of Food Technologists for the Food and Drug Administration of the U.S. Department of Health and Human Services

December 31, 2001

IFT/FDA Contract No. 223-98-2333
Task Order No. 4
Evaluation and Definition of Potentially Hazardous Foods