The FDA on Nov. 15 issued its final rule on food traceability, with no significant differences from the rule first proposed and revealed in September 2020. It is designed to hasten identification and removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths.
The compliance date is three years after the rule’s effective date, making it sometime in mid-January of 2026.
With the cooperation of the greater food industry, the traceability rule will enable the FDA to more rapidly and effectively identify the origin and travel of certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death and minimize overly broad advisories or recalls that implicate unaffected food products.
At the core of the rule is the Food Traceability List (FTL). That list focused efforts on food categories that were the source of many, if not most, of the FDA’s recent recalls: fresh and fresh-cut fruits and vegetables, shell eggs, nut butters, ready-to-eat deli salads, cheeses and seafood products.
The key requirement within the final rule is that any company manufacturing, processing, packaging or holding products on the FTL must maintain records, including key data elements (KDEs) related to critical tracking events (CTEs). In the event of an incident, covered firms, 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 does include 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.
The Food Traceability Final Rule is an outgrowth of the FDA’s New Era of Smarter Food Safety Blueprint and the Food Safety Modernization Act.
See the FDA rule at bit.ly/3ghn5PO
