Seafood Guidance Documents & Regulatory Information

FDA operates a mandatory safety program for all fish and fishery products under the provisions of the Federal Food, Drug and Cosmetic (FD&C) Act, the Public Health Service Act, and related regulations. The FDA program includes research, inspection, compliance, enforcement, outreach, and the development of regulations and guidance. As a cornerstone of that program, FDA publishes the Fish and Fisheries Products Hazards and Controls Guidance, an extensive compilation of the most up-to-date science and policy on the hazards that affect fish and fishery products and effective controls to prevent their occurrence. The fourth edition of this guidance document, which has become the foundation of fish and fishery product regulatory programs around the world, is now available.

 

Regulations

• Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products; Federal Register Final Rule - 60 FR 665095 (December 18, 1995)

  • Crabmeat; Amendment of Common or Usual Name Regulation; Proposed Rule - 21 CFR part 102 (April 23, 1998)

  • Proposal To Establish Procedures for the Safe Processing and Importing of Fish and Fishery Products; Proposed Rule - 21 CFR Parts 123 and 1240 (January 28, 1994)

  • Proposal To Establish Procedures for the Safe Processing And Importing of Fish and Fishery Products; Correction - 21 CFR Parts 123 and 1240 (March 3, 1994)

• Enhanced Aquaculture and Seafood Inspection - Report to Congress (November 20, 2008)

Guidance

• Draft Guidance for Industry: Purchasing Reef Fish Species Associated with the Hazard of Ciguatera Fish Poisoning (March 2013)

• Fish and Fishery Products Hazards and Controls Guidance: 4th Ed. (April 2011)

  • Fish and Fishery Products Hazards and Controls Guidance: 4th Ed. (PDF - 4.74MB)

• Guidance for Industry: The Seafood List - FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce (July 2012)

• 1991 Letter to Seafood Manufacturers Regarding the Fraudulent Practice of Including Glaze (ice) as Part of the Weight of Frozen Seafood (February 2009)

• Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association (January 2009; Revised February 2009)

• Guidance for Industry - Voluntary Third-Party Certification Programs for Foods and Feeds (January 2009)

  • FR Notice request for comments on Third-Party Certification Program  (April 2, 2008) - Closed

  • The FR notice announcing the Shrimp Pilot Program (PDF - 61KB) (July 10, 2008)

  • Shrimp pilot report (PDF - 198KB) (July 2011)

• Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products (July 2001)

• Seafood HACCP Transition Policy (December 1999)

• Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association (November 2004)

• Guidance for Industry: Implementation of Section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)) Regarding the Use of the Term "Catfish" (December 2002)

• Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association (February 2009)

• Draft Guidance and Protocol for Industry and Food and Drug Administration Staff: Certification of Fish and Fishery Products for Export to the European Union and European Free Trade Association (January 2008)

• Guidance for Industry: HACCP Regulation for Fish and Fishery Products; Questions and Answers for Guidance to Facilitate the Implementation of a HACCP System in Seafood Processing (January 1999)