The US Food and Drug Administration (FDA) has issued a final rule on food traceability designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
Foods subject to the final rule requirements appear on the Food Traceability List (FTL). This includes certain seafood products as well as fresh cut fruits and vegetables, shell eggs and cheeses.
At the core of the final rule is a requirement that persons who manufacture, process, pack or hold food on the FTL maintain records including key data elements (KDEs) related to critical tracking events (CTEs). Covered firms and farms, retail food establishments and restaurants will be required to provide information to the FDA within 24 hours, or some reasonable time to which the FDA agrees.
The final rule provides full and partial exemptions for some entities and foods, such as certain small producers, small retail food establishments and restaurants, farms that sell food directly to consumers, and foods that receive certain types of processing, among others.
It aligns with current industry best practices and covers domestic firms, retail food establishments, restaurants and farms, as well as foreign firms and farms producing food for US consumption.
According to the San Francisco-based Global Dialogue on Seafood Traceability (GDST), the publication of the rule marks the most significant change in US food traceability requirements since 2010, and also creates 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 20 January 2026 to come into compliance with the new rules, it explained.
It further advises that 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, with the new rule putting 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.
GDST said the regulations take an approach to event-based traceability that is closely aligned with its own standards, including an emphasis on key data elements and critical tracking events.
“The release of the new Section 204 traceability regulations is a game-changer for anyone selling seafood into the US market,” GDST Executive Director Greg Brown said. “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.”
In the near future, GDST will be providing opportunities for companies to understand the regulations and how they relate to GDST implementation.
GDST was organised in 2017 by WWF and the Institute of Food Technologists as an international, business-to-business platform to advance a unified framework for interoperable and verifiable seafood traceability.
