The USA food & Drug Administration, (FDA) has published its final rule concerning traceability protocols for food products vulnerable to contamination. Companies and organisations who manufacture, process, pack or hold foods including produce, cheeses will be subject to record-keeping requirements during production.
The final rule on food traceability is 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). The FTL includes 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.
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). The firms and farms, retail food establishments and restaurants under its scope will be required to provide information to the FDA within 24 hours, or some reasonable time to which the FDA agrees.
The Critical Tracking Events in the final rule are harvesting, cooling (before initial packing), initial packing of a raw agricultural commodity other than food obtained from a fishing vessel, first land-based receiving of food obtained from a fishing vessel, shipping, receiving, and transformation of the food.
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 and covers domestic firms, retail food establishments, restaurants, and farms, as well as foreign firms and farms producing food for consumption in the USA – so will affect food companies in the EU and UK exporting to there.
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).
Because the Food Traceability Final Rule requires entities to share information with other entities in their supply chain, 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 recordkeeping requirements is Tuesday, January 20, 2026.
This article was created in collaboration with AIPIA (the Active and Intelligent Packaging Industry Association). Packaging Europe and AIPIA are joining forces to bring news and commentary about the active and intelligent packaging landscape to a larger audience. To learn more about this partnership, click here.