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Evaluation and Definition of Potentially Hazardous Foods

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Evaluation and Definition of Potentially Hazardous Foods 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 Acknowledgments Chapter 5. Effect of Preservation Technologies and 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. Oxidation-reduction 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 end-use 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. Non-Potentially 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 five-year contract with the Institute of Food Technologists (IFT) to Board to advise IFT on the FDA contract and on the individual provide scientific review
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