On September 23, 2020, the Food and Drug Administration published in the Federal Register a proposed rule [Docket No. FDA-2014-N-0053] to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the FDA has designated for inclusion on the Food Traceability List. The proposed rule would require these entities to establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods. The proposed requirements are intended to help the Agency 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. We are issuing this proposed rule in accordance with the FDA Food Safety Modernization Act (FSMA).

Submit either electronic or written comments on the proposed rule by January 21, 2021. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 23, 2020.