FDA Rules on FMSA Section 204 Require Event-Based Traceability

In a much-anticipated move, the U.S. Food and Drug Administration last week released the final version of regulations implementing Section 204 of the Food Safety Modernization Act.  The publication of the rule, announced on the FDA website with official text available on the U.S. Federal Register, marks the most significant change in U.S. food traceability requirements since 2010, creating a new regulatory regime that will have global impact.  All foreign and domestic companies participating in supply chains that sell food into the US market will have until January 20, 2026, to come into compliance with the new rules.

The new Section 204 regulations are especially relevant for companies that are GDST members or are considering implementing the GDST’s global standards for interoperable seafood traceability. The new rule puts a premium on digital traceability, requiring all actors in covered food supply chains to provide an electronic sortable spreadsheet containing relevant traceability information to the FDA within 24 hours of a request.  The regulations also take an approach to “event based” traceability that is closely aligned with GDST standards, including an emphasis on “key data elements” and “critical tracking events.”  Companies that implement the GDST standards will have a significant head start and an advantage in meeting the requirements of the new rule.

“The release of the new Section 204 traceability regulations is a game-changer for anyone selling seafood into the U.S. market,” said GDST Executive Director Greg Brown.  “Given how closely the new rules align with the GDST approach, it is clear that implementing the GDST standards offers a business-smart path towards the future of seafood traceability.”

Many GDST partners and stakeholders will recall the briefing sessions held by the GDST while the new regulations were being drafted.  In the near future, GDST will again be providing opportunities for companies to understand the regulations and how they relate to GDST implementation.  The expert GDST team is already hard at work analyzing the new rules (which run to more than 500 pages!).  Stand by for announcements of GDST briefings and Q&A sessions in the weeks ahead.

The new Section 204 regulations will have a significant impact around the world, and GDST is right there to help companies be ready.  Our most in-depth briefings and support services will be available only to GDST partners—so if your company or organization is not yet a GDST partner, now is the time to check out our flexible partnership options!

For more information on GDST partnership, visit our website and click on “Get Involved”!

November 21, 2022