FDA Issues Final Rule on Food Traceability

Those who handle food on the agency’s list will need to do extra record-keeping starting in January 2026.

November 16, 2022

ALEXANDRIA, Va.—The Food and Drug Administration (FDA) has issued its final rule on food traceability. The rule is meant to establish additional traceability record-keeping requirements (beyond what is already required) for entities that manufacture, process, pack or hold any foods included on the FDA’s Food Traceability List.

The final rule, “Requirements for Additional Traceability Records for Certain Foods,” is part of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA).

“The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths,” according to the FDA.

At the core of this rule is a requirement that those who are subject to the rule (people who manufacture, process, pack or hold foods on the FTL), maintain records containing Key Data Elements associated with specific Critical Tracking Events and provide information to the FDA within 24 hours or within some reasonable time to which the agency has agreed.

Because this final rule requires people to share information with other entities in their supply chain, the FDA said it believes that the most effective and efficient way to implement the rule is to have all persons subject to the requirements come into compliance by the same date. The compliance date for all persons subject to the record-keeping requirements is Tuesday, January 20, 2026.

In December, the FDA released its Foodborne Outbreak Response Improvement Plan to enhance the speed, effectiveness, coordination and communication of investigations into outbreaks of foodborne illness.

In February 2021, NACS submitted comments to the FDA on its then proposed rule to establish additional traceability record-keeping requirements for certain foods, based on Section 204 of the FSMA, as part of the New Era of Smarter Food Safety initiative.

NACS signaled support for efforts to boost food traceability and safety in the food system. However, expressed concern that small retailers, which represent 63.5% of all convenience stores in the United States, would not be able to meet the proposed additional recordkeeping requirements.

NACS has several food-safety resources for foodservice providers. Find them on the Food Safety topics page. NACS also offers free webinar on how to build a strong and effective food safety and cleanliness culture. The webinar, “The Case for Cleanliness,” is available to view on demand.