IWLA submitted comments to the U.S. Food and Drug Administration (FDA) on its proposal to establish additional traceability recordkeeping requirements 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 comments seek to provide clarity to the FDA on the role of 3PL warehouses in various import scenarios that may trigger traceability recordkeeping requirements. IWLA stressed that 3PLs do not purchase, own, sell, nor hold title to the products in the warehouse, and as such, would not be “first receivers” as defined in the proposal. The comments also sought interpretation and guidance on several scenarios that the FDA had not clearly outlined in the proposed rule.

The proposed rule is a critical 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 to 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.

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