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FDA Releases Updated Chapters and Appendices to the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition

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By Milthon Lujan

The U.S. Food and Drug Administration (FDA) is announcing the availability of specific chapters, appendices and addenda of the “Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition” now dated June 2021.

The FDA has determined specific chapters, appendices, and addenda of the guidance would be updated with the availability of new science. This update includes:

Chapter 3: Potential Species-Related and Process-Related Hazards
Chapter 11: Aquaculture Drugs
Appendix 1: Forms
Appendix 2: Product Flow Diagram – Example
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 Aquaculture Drugs
Appendix 12: Unapproved Aquaculture Drugs
Addendum 1: Fish and Fishery Products (21 CFR 123) and Control of Communicable Diseases (21 CFR 1240.60)
Addendum 2: current Good Manufacturing Practices (cGMPs)

The modifications can be reviewed through the “Guidance to Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition – June 2021” section of the guidance document. The updated guidance supports and complements the FDA’s regulations for the safe and sanitary processing and importing of the fish and fishery products using hazard analysis and critical control point methods. Updates may be accessed through the FDA’s Seafood website or the Fish and Fishery Products Hazards and Controls Guidance Page. 

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