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        Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

Seafood Guidance Documents & Regulatory Information

                        
                Fish and Fishery Products Hazards and Controls
          FDA Seafood List Updates for 2021
          FDA Seafood List Updates for 2022
          FDA Seafood List Updates for 2023 Home
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          Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
          Seafood Guidance Documents & Regulatory InformationGuidance Documents & Regulatory Information by Topic (Food and Dietary Supplements) Seafood Guidance Documents & Regulatory Information
  	
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    PrintFDA 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

21 CFR Part 123 – Fish and Fishery Products (September 17, 2015)
	21 CFR Part 1240.60 – Molluscan shellfish (December 18, 2018)
	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; Correction - 21 CFR Parts 123 and 1240 (March 3, 1994)
	Enhanced Aquaculture and Seafood Inspection - Report to Congress (November 20, 2008)Guidance

Guidance for Industry: The Seafood List - FDA’s Guide to Determine Acceptable Seafood Names (August 2023)
	Fish and Fishery Products Hazards and Controls Guidance: June 2022 Edition (June 2022)
	Guidance for Industry: Reconditioning of Fish and Fishery Products by Segregation (April 2022)
	Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (December 2021)
	The FDA reopens the comment period for Draft Guidance for FDA Staff CPG Sec 540.525 DRAFT: Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) to Federal Register for commenting (December 2021)
	Please see the Constituent Update FDA Issues Draft Compliance Policy Guide for Decomposition and Histamine in Scombrotoxin (Histamine)-forming Fish and Fishery Products for additional information
	Controlling the Hazard of Clostridium botulinum Growth and Toxin Formation in Reduced Oxygen Packaged Fish and Fishery Products Including Refrigerated, Vacuum-Packed Crawfish Tail Meat (December 2018)
	Guidance for Industry: Use of the Terms “Brown King Crab” and “Golden King Crab” in the Labeling of Human Food Products (November 2017)
	Guidance for Industry: Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China  (June 2017)
	Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (January 2017)
	Fish and Fishery Products Hazards and Controls Guidance: 4th Ed. (August 2019)
	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)
	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: 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: Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products (July 2001)
	Processing Parameters Needed to Control Pathogens in Cold-Smoked Fish (March 2001)
	Guidance for Industry: Seafood HACCP Transition Policy (December 1999)
	Guidance for Industry: Questions and Answers for Guidance to Facilitate the Implementation of a HACCP System in Seafood Processing (January 1999)Additional Information

Regulatory Fish Encyclopedia (RFE)
	Imported Seafood Safety Program
	Seafood Species Substitution and Economic Fraud
	Aquacultured Seafood
	Scombrotoxin Poisoning and Decomposition
	Alaska Pollock Labelling Faces New Requirements (January 2016)
	Assessment of the Third-Party Certification Pilot for Aquacultured Shrimp (July 2011)

                                                                                  Content current as of:
      08/31/2023
                  
                   
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Seafood/Seafood ProductSeafood Guidance Documents & Regulatory Information                
                          

                        Fish and Fishery Products Hazards and Controls
          FDA Seafood List Updates for 2021
          FDA Seafood List Updates for 2022
          FDA Seafood List Updates for 2023
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