FDA extends deadline to meet enhanced traceability requirements

Food manufacturers, processors and packers will have 30 additional months beyond a previous deadline to meet enhanced U.S. Food and Drug Administration traceability requirements.

Section 204(d) of the Food Safety Modernization Act (commonly known as FSMA 204), had been set to take effect in January 2026. On March 20, the FDA said it would extend the compliance date by 30 months “using appropriate procedures at a later time, including publishing a proposed rule in the Federal Register,” according to a statement on its website.

FSMA 204 requires records containing Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs) to be maintained and quickly providable to the FDA by those who manufacture, process, pack or hold foods included on the Food Traceability List (FTL).  The goal of the rule is faster identification and removal of potentially contaminated food from the market.

“Accordingly, the compliance date extension does not amend, nor do we intend to amend, the requirements of the final rule, which will improve food safety and protect public health,” the FDA said in the statement. “Instead, the compliance date extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements — ultimately providing FDA and consumers with greater transparency and food safety.”

The FDA said it would use the extended period to continue to provide technical assistance and other resources to assist with industry implementation.

“Even those few entities who are well positioned to meet the final rule’s requirements by January 2026 have expressed concern about the timeline, in part because of their reliance on receiving accurate data from their supply chain partners, who are not similarly situated,” the agency said. “Therefore, FDA intends to allow industry additional time, across all regulated sectors, to fully implement the final rule’s requirements.”

ReposiTrak is a global food traceability and regulatory compliance network which connects food supply chain companies and wholesalers through an inventory management platform. Company chair and CEO Randy Fields talked with Produce Processing in 2024 about how ReposiTrak, which recently expanded its data-sharing capabilities, helps companies facing compliance challenges.