FDA SGR 129 Fish and Fishery Products Hazards and Controls User Guide
- June 5, 2024
- FDA
Table of Contents
FDA SGR 129 Fish and Fishery Products Hazards and Controls
Additional copies may be purchased from:
- Florida Sea Grant
- IFAS – Extension Bookstore University of Florida
- P.O. Box 110011 Gainesville, FL 32611-0011 800-226-1764
- www.ifasbooks.com
Copies of this guidance document may be downloaded from:www.FDA.gov/Seafood
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
240-402-2300
JUNE 2022
TABLE OF CONTENTS:
FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDANCE – JUNE 2022 EDITION
| Section | Page |
|---|---|
| Guidance for Industry: Fish and Fishery Products Hazards and Control Guidance |
G – 1
CHAPTER 1: General Information| 19
CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan| 21
CHAPTER 3: Potential Species-Related and Process-Related Hazards| 3 – 1
CHAPTER 4: Pathogens from the Harvest Area| 75
CHAPTER 5: Parasites| 91
CHAPTER 6: Natural Toxins| 6 – 1
CHAPTER 7: Scombrotoxin (Histamine) Formation| 113
CHAPTER 8: Other Decomposition-Related Hazards| 153
CHAPTER 9: Environmental Chemical Contaminants Including Pesticides| 9 – 1
CHAPTER 10: Methylmercury| 181
CHAPTER 11: Aquaculture Drugs| 11 – 1
CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other than
Clostridium botulinum )
as a Result of Time and Temperature Abuse
| 209
CHAPTER 13: Clostridium botulinum Toxin Formation| 245
CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of
Inadequate Drying| 293
CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes|
309
CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization|
315
CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain
Raw Product Characteristics| 331
CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and
Specialized Cooking
Processes
| 345
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance
Substances| 19 – 1
CHAPTER 20: Metal Inclusion| 385
CHAPTER 21: Glass Inclusion| 395
APPENDIX 1: Forms| A1 – 1
APPENDIX 2: Product Flow Diagram – Example| A2 – 1
Section| Page
---|---
APPENDIX 3: Critical Control Point Decision Tree| A3 – 1
APPENDIX 4: Bacterial Pathogen Growth and Inactivation| 417
APPENDIX 5: FDA and EPA Safety Levels in Regulations and Guidance| A5 – 1
APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw| 443
APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood
Processing-Public Health Impacts| 451
APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish
and Fishery Products| A8 – 1
APPENDIX 9: Allergen Cross-Contact Prevention| A9 – 1
APPENDIX 10: Allergen Cleaning and Sanitation for the Control of Allergens|
A10 – 1
APPENDIX 11: Approved Aquaculture Drugs| A11 – 1
APPENDIX 12: Unapproved Aquaculture Drugs| A12 – 1
ADDENDUM 1: Fish and Fishery Products (21 CFR 123) and Control of Communicable
Diseases (21
CFR 1240.60)
| AD1 – 1
ADDENDUM 2: current Good Manufacturing Practices (cGMPs)| AD2 – 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
OFFICE OF FOOD SAFETY