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FDA updates Fish and Fishery Products Hazards and Controls Guidance

New specific chapters, appendices and addenda were added to this guidance that is intended to assist processors of fish and fishery products in the development of their HACCP plans.

FDA updates Fish and Fishery Products Hazards and Controls Guidance

June 24, 2021


The U.S. Food and Drug Administration (FDA) released new specific chapters, appendices and addenda of the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition. This guidance represents the agency's current thinking on the hazards associated with fish and fishery products and appropriate controls for those hazards.

This guidance is intended to assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find information in this guidance that will help them identify hazards that are associated with their products, and help them formulate control strategies.

The new chapters and appendixes include:

Chapter 3: Potential Species-Related and Process-Related Hazards

Chapter 11: Aquaculture Drugs

Appendix 1: Forms 

Appendix 2: Sample Product Flow Diagrams 

Appendix 3: Critical Control Point Decision Tree

Appendix 5: FDA and EPA Safety Levels in Regulations and Guidance

Appendix 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products

Appendix 11: Approved Animal Drugs for Aquaculture Use 

Appendix 12: Unapproved Animal Drugs for Aquaculture 

Addendum 1: Fish and Fishery Products (21 CFR 123) and Control of Communicable Diseases (21 CFR 1240.60) 

Addendum 2: Current Good Manufacturing Practices (cGMP) 

Check out the updates here.

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