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United States of America

 

USA Regulations for Fish and Fishery Products

For more information on the general requirements for imports of Bivalve Molluscs, click HERE

General requirements for imports

Food Safety Modernization Act (FSMA): aims to ensure the US food supply is safe by shifting the focus from responding to contamination to preventing it.

  • Title I “Improving capacity to prevent food safety problems”: providing guidance on inspections of records, registration of food facilities, hazard analysis and risk-based preventive controls, standards for produce safety and sanitary transportation of food.
  • Title III “Improving the safety of imported food” : providing guidance on the foreign supplier verification program, voluntary qualified importer program, authority to require import certifications for food, prior notice of imported food shipments, building capacity of foreign governments with respect to food safety, inspection of foreign food facilities and accreditation of third-party auditors.

Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products: outlines requirements for the application of Hazard Analysis Critical Control Point (HACCP) for imported seafood.

Fish and Fishery Products Hazards and Controls Guidance Fourth Edition: is intended to assist processors of fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) implementation plans. Processors of fishery products can find information to help them identify hazards and formulate control strategies.

FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals: requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standards.

Guidance for industry on Seafood HACCP and the FDA Food Safety Modernization Act: providing additional information and clarifications regarding the seafood HACCP regulation in connection with the FSMA.

Further useful information can be found in the section on questions and answers for guidance to facilitate the implementation of a HACCP system in seafood processing.

Additives, contaminants, antimicrobials and residues

In Guidance for Industry, the action levels for poisonous or deleterious substances in human food and animal feed are established. In particular, this guidance outlines the action levels for the following substances in fishery products: aldrin, dieldrin, chlordane, chlordecone, DDT, DDE, TDE, heptachlor, heptachlor epoxide, mercury and mirex.

Action levels and tolerances are available at the following link:

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm077969.htm

Fish and Fishery Products Hazards and Controls Guidance Fourth Edition: providing guidance in Chapters 9, 10 and 11 on the requirements for chemical contaminants, pesticides, methylmercury and aquaculture drugs. Appendix 5 contains the tolerated safety levels in the United States of America.

Chapter 9: Environmental Chemical Contaminants and Pesticides;
Chapter 11: Aquaculture Drugs; and
Appendix 5: FDA and Environmental Protection Agency (EPA) Safety Levels.

Microbiological and organic criteria

Fish and Fishery Products Hazards and Controls Guidance Fourth Edition: providing guidance in Chapters 4, 5, 6 and 7 on the requirements for pathogens, parasites, natural toxins and histamine. Appendix 5 contains the tolerated safety levels in the United States of America.

Chapter 4: Pathogens from the Harvest Area;
Chapter 5: Parasites;
Chapter 6: Natural Toxins (such as: PSP, NSP, DSP, ASP, CFP AZP);
Chapter 7: Scombrotoxin (Histamine) Formation; and
Appendix 5: FDA and EPA Safety Levels.

In Guidance for Industry, the action levels for poisonous or deleterious substances in human food and animal feed are established. This guidance provides the limits for paralytic shellfish toxin in clams, mussels and oysters. 

Traceability

Food Safety Modernization Act (FSMA): aims to ensure that the US food supply is safe by shifting the focus from responding to contamination to preventing it.

Sections 204 and 206 of Title II “Improving capacity to detect and respond to food safety problems” provide guidance on enhancing tracking and tracing of food, recordkeeping and the mandatory recall authority.

Food and Drug Administration Amendments Act of 2007, Public Law 110-85, Section 1006 – Enhanced Aquaculture and Seafood Inspection: describes the feasibility of developing a traceability system for all seafood products, both domestic and imported, for the purpose of identifying the processing plant of origin of such products. 

Presidential Memorandum “Establishing a Comprehensive Framework to Combat Illegal, Unreported, and Unregulated Fishing and Seafood Fraud”: establishes a Presidential Task Force on Combating Illegal, Unreported, and Unregulated (IUU) Fishing and Seafood Fraud (Task Force), to be co-chaired by the Secretaries of State and Commerce. The intention is to identify and develop operational standards needed for an effective seafood traceability program to combat seafood fraud and IUU fishing.

Labelling and packaging

Guidance for Industry is provided in the Food Labelling Guide on general food labelling requirements, nutrition labelling and ingredient lists. 

How do we find the last consolidated version of the Regulations?

At the following link you can find all the guidance and regulations:

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/default.htm

At the following link you can find the “Food Safety Modernization Act”:

https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247548.htm

At the following link you can find the “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”:

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/
Seafood/ucm176892.htm

 

Last update: 19/11/2018

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