September 24, 2020
On September 21, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods. The FDA also published a draft “Food Traceability List,” which describes the foods that would be subject to the proposed requirements. The list includes leafy greens, fresh-cut fruits and vegetables, some types of fish, shell eggs, nut butters, and more.
The agency proposes recordkeeping requirements for foods identified on the Food Traceability List, including shell eggs, to improve the traceability information during outbreak investigations and trace forward investigations for recall events. The proposed rule would require persons who manufacture, process, pack or hold foods identified on the list to keep certain records describing their traceability operations.
The core components of the proposed rule are the requirements to establish and maintain records containing key data elements (KDEs) associated with different critical tracking events (CTEs) in a listed food’s supply chain. These include the growing, receiving, transforming, creating, and shipping of listed foods. The proposed recordkeeping requirements emphasize the importance of documenting the applicable traceability lot codes and linking these codes to other KDEs at critical points in the supply chain to aid product tracing during an investigation of a foodborne illness outbreak or a recall.
The proposed rule provides some full and partial exemptions for specific shipments of products originating from certain types of operations. Exemptions that affect egg producers will depend on the shipment and comingling of eggs from other farms, but there are no overarching exemptions that would exempt most egg farms.
UEP staff and consultants are reviewing the rule and will provide more information on how it pertains to egg producers soon. They also plan to participate in the FDA public meetings about the rule and work with UEP’s Food Safety committee to draft industry comments.
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