FDA finalizes new food traceability record-keeping rules

Additional FDA record-keeping rules regarding food traceability have been finalized, affecting a range of specified foods.

The Requirements for Additional Traceability Records for Certain Foods establishes traceability record-keeping requirements beyond those in existing regulations for persons who manufacture, process, pack or hold foods included on the Food Traceability List. The finalized rule is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act.

The new requirements will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer food-borne illnesses and/or deaths, according to the FDA.

Persons subject to the rule must maintain records containing Key Data Elements associated with specific Critical Tracking Events and provide information to the FDA within 24 hours or a time frame to which the FDA has agreed. Critical Tracking Events include stages of harvesting, production, processing, distribution and receipt.

The final rule covers domestic and foreign companies producing food for U.S. The compliance date is Jan. 20, 2026.

The Food Traceability List includes certain types of cheeses, leafy greens, melons, peppers, shell eggs, tomatoes and seafood, among other categories.