The US Food and Drug Administration’s Division of Seafood Safety is announcing the availability of specific chapters and appendixes of the “Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition” now dated August 2019. FDA has determined specific chapters and appendixes of the guidance could be updated with the availability of new science, opposed to withholding the information to publish the entire guidance at once. With that thought in mind, FDA has updated: Chapter 3 - Potential Species-Related and Process-Related Hazards; Chapter 6 - Natural Toxins; and Chapter 19 - Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives, as well as, Appendix 5 - FDA and EPA Safety Levels in Regulations and Guidance; and Appendix 8 - Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products with the addition of two (2) new appendixes: Appendix 9 -Allergen Cleaning and Sanitation; and Appendix 10 - Allergen Cross-Contact Prevention. Chapter modifications may be reviewed through the “Guidance to Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition – August 2019” section of the guidance document. The updated guidance supports and complements FDA’s regulations for the safe and sanitary processing and importing of the fish and fishery products using hazard analysis and critical control point (HACCP) methods. Updates may be accessed through FDA’s Seafood website at www.fda.gov/seafood or the Fish and Fishery Products Hazards and Controls Guidance page.
This guidance represents the Agency’s current thinking on fish and fishery hazards and controls. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.