FDA published final rule about new traceability protocols for food products vulnerable to contamination; people who manufacture, process, pack or hold foods including produce, cheeses will be subject to record-keeping requirements during production

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November 16, 2022 (press release) –

Today, the U.S. Food and Drug Administration (FDA) issued a final rule on food traceability 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). 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 and 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).

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