FDA Expands Food Tracing Requirements

The U.S. Food and Drug Administration 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 term refers not only to the foods specifically listed, but also to any foods that contain listed foods as ingredients.

IWLA’s Food Council is presently reviewing the proposed rule.

The proposed rule, “Requirements for Additional Traceability Records for Certain Foods,” 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 are intended to allow 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. 

Supply participants would be required to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs).  KDEs include lot codes. 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  encourages the voluntary adoption of these practices industry-wide.