The U.S. Food and Drug Administration has made two updates to its materials for stakeholders regarding the proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule).
The 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 have been extended and will now be available for public comment until February 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.