FDA announces final rule for food traceability

November 17, 2022

On Nov. 15, FDA issued a final rule on food traceability designed to facilitate faster identification andrapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.

Foods subject to the final rule requirements are on the  Food Traceability List (FTL) and include 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.

In the coming months, UEP staff, consultants, and the Food Safety Committee will navigate the final rule to educate and prepare the industry before the effective date of January 20, 2026.

FDA is holding a webinar on Dec. 7 to provide an overview of the final rule. Topics covered will include the foods and entities covered by the rule, exemptions from the rule, and recordkeeping requirements. Click here for to register and for more information. Questions can be submitted in advance when registering or emailed to FSMA204Traceability@fda.hhs.gov.

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.

The final rule aligns with current industry best practices. It covers domestic firms, retail food establishments, restaurants, and farms, as well as foreign firms and farms producing food for U.S. consumption. 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 (FSMA). For more information, see the Federal Register Notice.