FDA

What’s New

• The FDA Moves into Third Phase of Artificial Intelligence Imported Seafood Pilot Program August 2022
• On June 30, 2021, FDA announced the plan to conduct a limited survey of highly consumed seafood in the United States to provide additional data on per- and polyfluoroalkyl substances (PFAS) in commercially available fish and shellfish at retail in the United States. For results from this survey, please see FDA Shares Results on PFAS Testing in Seafood
• Publication of an updated Section of the Fish and Fishery Products – Hazards and Controls Guidance. The following sections of the Guide have been updated as of June 2022:
  • Cover Page
  • Guidance for Industry: Fish and Fishery Products Hazards and Controls Guidance
  • Table of Contents
  • Chapter 9: Environmental Chemical Contaminants Including Pesticides
• Steven Bloodgood, Acting Director for the Division of Seafood Safety and Fazila Shakir, MHS, Regulatory Cooperation and Partnerships Staff Director, discuss regulatory partnerships to help ensure the safety of imported food. See Enhancing the Safety of Imported Shrimp Through Regulatory Partnerships.
• FDA Issues Guidance for Industry on Reconditioning Fish and Fishery Products by Segregation
• The FDA reopens the comment period for Draft Guidance for FDA Staff CPG Sec 540.525 DRAFT: Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) to Federal Register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
  • 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
• Bivalve Molluscan Shellfish Trade with the European Union resumes. The FDA announced the final equivalence determination in September 2020 and negotiations between the U.S. and the EU were completed in 2022. The resumption of bilateral trade in bivalve molluscan shellfish was announced on February 27. For the first time since 2011, U.S. producers, beginning in the states of Massachusetts and Washington, are eligible to export live, raw and processed bivalve molluscan shellfish to the EU, including oysters, clams, mussels, and whole or roe-on scallops. EU producers in Spain and the Netherlands are also eligible to export live and raw bivalve molluscan shellfish to the United States. See: United States and European Union to Resume Trade in Live, Bivalve Shellfish. See also: Webinar on Shellfish Equivalence with European Union Member States – 10/01/2020 – 10/01/2020 | FDA for more information on the process for recognizing additional States and procedures for firm listing and export certification.
• Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act
• Marine Biotoxin Management for Molluscan Shellfish Training Video

Guidance for Industry

Publication of updated sections of the Fish and Fishery Products-Hazards and Controls Guidance.