Background

The Food and Drug Administration is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold imported and domestic foods that (1) the FDA designates as high-risk or (2) contain such designated foods as ingredients. Comments on this proposal are due no later than Jan. 21, 2021.

Under this proposed rule, subject entities would be required to establish and maintain records containing standardized key data elements associated with critical tracking events in the supply chain for designated foods, such as growing, shipping, receiving, creating, and transforming the foods. This rule also specifies the information firms would have to send in certain circumstances to the next entity in the supply chain. The FDA notes that while some elements of internal product tracing information are already kept by many food producers, manufacturers, distributors, and retailers, the length of time information is retained and the amount of information shared between trading partners varies among firms. The proposed rule would address this by standardizing the records required.

The proposal includes full exemptions for small retail food establishments, small farms, farms selling directly to consumers, certain food produced and packaged on a farm, food that receives certain types of processing, and transporters of food. Partial exemptions would apply to certain commingled raw agricultural commodities, fishing vessels, retail food establishments that receive a listed food directly from a farm, and farm-to-school and farm-to-institution programs. In addition, subject persons could request modified requirements or an exemption for a specific type of food or entity provided it does not jeopardize public health.

For more information, please contact Domenic Veneziano at (202) 734-3939.

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