The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables the FDA to better protect public health by helping to ensure the safety and security of the food supply. It requires FDA to promulgate food safety rules that focus on preventing food safety issues rather than relying on detecting issues and reacting to them after they occur. FSMA recognizes that FDA has previously established a preventive control type regulation for fish and fishery products (Title 21, Code of Federal Regulations (21 CFR) part 123, the seafood HACCP regulation) based on the Hazard Analysis and Critical Control Point (HACCP) concept. See FSMA §§ 103(a), 103(f), 105(d), and 301 (§§ 418(j) and 805(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 350g(j), 350g note, 350h note, and 384a(e))). The seafood HACCP regulation requires seafood processors to identify food safety hazards that are reasonably likely to occur and to develop plans for the control of those hazards.

In addition, the seafood HACCP regulation requires importers of certain seafood products to comply with requirements designed to help ensure that these imported products are processed in accordance with the seafood HACCP regulation.

Importantly, several of the regulations that FDA has issued under FSMA provide exemptions related to the seafood HACCP regulation. This guidance, first issued in August 2017, addresses those exemptions, and also provides information about the seafood HACCP regulation in connection with the FSMA regulations.

Though not the subject of this guidance, we also note that some seafood products are also subject to 21 CFR part 113 (Thermally Processed Low-Acid Foods Packaged in Sealed Containers). Certain FSMA regulations provide additional exemptions related to part 113.

This guidance summarizes how the following FSMA regulations affect processors and importers subject to the seafood HACCP regulation:

  • 21 CFR part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (CGMP & PC Regulation)
  • 21 CFR 1, subpart L, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (the FSVP Regulation)
  • 21 CFR 1, subpart M, Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications (Accredited Third-Party Certification Regulation)
  • 21 CFR part 121, Mitigation Strategies To Protect Food Against Intentional Adulteration (the IA Regulation)
  • 21 CFR 1, subpart O, Sanitary Transportation of Human and Animal Food (the ST Regulation)

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