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FDA announces Food Traceability Final Rule

Getty/iStockphoto Fruit packers weigh strawberries for packaging
The rule aims to increase traceability so potentially contaminated food can quickly be identified and removed from the market.

The U.S. Food and Drug Administration issued the Food Traceability Final Rule Nov. 15 to establish additional recordkeeping requirements. The rule is scheduled to be published by the Federal Register and take effect on Nov. 21.

The FDA announced last week that it submitted the final rule to the Office of the Federal Register, meeting the Nov. 7 deadline outlined in the Food Safety Modernization Act.

The goal of FDA's rule is to increase traceability so potentially contaminated food can quickly be identified and removed from the market, resulting in fewer foodborne illnesses and deaths. Foods subject to additional recordkeeping under the new rule's requirements appear on the Food Traceability List, including fresh-cut fruits and vegetables, shell eggs, and nut butters, as well as certain fresh fruits, fresh vegetables, ready-to-eat deli salads, cheeses, and seafood products.

“While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products,” the agency says. FDA encourages the voluntary adoption of the practices across the food industry.

The rule requires anyone who manufactures, processes, packs or holds food on the FTL to maintain records including Key Data Elements related to Critical Tracking Events. Covered firms and farms, retail food establishments and restaurants will be required to provide information to the FDA within 24 hours after a request is made.

FDA's rule grants full and partial exemptions for some entities, such as certain small producers, small food retailers restaurants, farms that sell food direct to consumers, and foods that receive certain types of processing.

Compliance deadline

The Food Traceability Final Rule requires entities to share information with others in their supply chain. The compliance date for all persons subject to the recordkeeping requirements is Jan. 20, 2026. 

The Food Traceability Final Rule is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act.

TAGS: Regulatory
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