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FDA Sends FSMA Proposed Rule for Food Traceability to Office of Federal Register

FDA is proposing to establish additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack or hold foods the agency has designated for inclusion on the Food Traceability List.

November 7, 2022

FDA

SILVER SPRING, Md. — Today, FDA said it met its obligation to send the FSMA Final Rule: Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal Register (OFR) by the Nov. 7, 2022, deadline. Publication is managed by the OFR and the FDA anticipates publication within one or two weeks after submission.

FDA is proposing to establish additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA). The proposed requirements would help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death. The comment periods for the proposed rule and information collection provisions ended Feb. 22, 2021.

At the core of this proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs).  While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products. FDA would encourage the voluntary adoption of these practices industry-wide.