Background

The Food and Drug Administration has issued a final rule designed to help the agency more effectively trace contaminated food, whether sourced in the U.S. or abroad.

Under this rule, which will take effect Jan. 20, 2023, persons who manufacture, process, pack, or hold foods the FDA has designated as high-risk and included on a new food traceability list will be required to maintain and provide to their supply chain partners specific information (key data elements) for certain critical tracking events in the handling of the food.

FTL foods currently include 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, cheeses (other than hard cheese), finfish, and crustaceans.

Critical tracking events will include harvesting, cooling, initial packing, receiving, transforming, and shipping subject foods.

The information that firms must keep and send forward varies depending on the type of supply chain activities they perform, from harvesting or production of the food through processing, distribution, and receipt at retail or other point of service.

Subject persons will also have to establish and maintain a traceability plan that describes their procedures for maintaining the required records, identifying FTL foods handled, and assigning traceability lot codes to FTL foods.

The FDA anticipates that under this rule it will be able to more rapidly and effectively identify the origin and route of travel of 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.

For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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