New FDA Rule to Improve Traceability of Foreign and Domestic Foods

Trade Update • Nov. 17, 2022

he U.S. Food and Drug Administration (FDA) issued a final rule, effective January 20, 2023, to improve the traceability of contaminated food, sourced domestically or internationally. The rule will establish additional record-keeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL).

FTL foods currently include cheeses (other than hard cheese), finfish, crustaceans, molluscan shellfish, bivalves, fresh leafy greens, melons, peppers, sprouts, herbs, tomatoes, cucumbers, tropical tree fruits, shell eggs, nut butters, fresh-cut fruits and vegetables, ready-to-eat deli salads.

The requirements established in the final rule will help the FDA rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded.

Traceability Plan

Subject persons will be required to keep traceability program records/develop a traceability plan for the FTL foods they handle. These records would include a description of the reference records in which the required information is maintained, an explanation of where on the records the required information appears, and if, applicable, a description of how reference records for different tracing events for a food are linked.

Subject persons must establish and maintain a list of foods on the FTL that they ship, including the traceability product identifier and traceability product description for each food, and a description of how the entity establishes and assigns traceability lot codes to foods on the FTL they originate, transform, or create, as well as any additional information necessary to understand the data provided within any of the records required, such as internal or external coding systems, glossaries, and abbreviations. Traceability program records be retained for 2 years after their use is discontinued.

Critical Tracking

Critical tracking events of the rule will include growing, transforming, creating, shipping, and receiving subject foods.