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.
For information on Federal/State food programs concerning shellfish, see Shellfish Programs & Shippers List.
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)
Enhanced Aquaculture and Seafood Inspection - Report to Congress (November 20, 2008)
Guidance
Guidance for Industry: Purchasing Reef Fish Species Associated with the Hazard of Ciguatera Fish Poisoning (November 2013)
Fish and Fishery Products Hazards and Controls Guidance: 4th Ed. (April 2011)
1991 Letter to Seafood Manufacturers Regarding the Fraudulent Practice of Including Glaze (ice) as Part of the Weight of Frozen Seafood (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)
Seafood HACCP Transition Policy (December 1999)
- 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)