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




















