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The FDA Food Safety Modernization Act (FSMA) currently requires businesses that process, pack or hold foods to maintain records for foods included on the FDA’s Food Traceability List. Recently, the FDA proposed additional traceability recordkeeping requirements. The proposed requirements are designed to help the FDA better identify recipients of those listed foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.

The foods listed on the Food Traceability List (FTL) include cheeses, leafy greens, shell eggs, nut butters, and fresh-cut fruits and vegetables—among others. These foods subject to the new requirements have been identified by independent academics and industry experts as having higher risk.

Two key sections of the proposed requirements are Key Data Elements (KDE) and Critical Tracking Events (CTE). The CTEs refer to critical points in the supply chain, and the KDEs call for the collection and communication of important traceability data, which should take place at the CTEs.

Key features of the proposed rule include:

Critical Tracking Events: The proposed rule identifies growing, receiving, transforming, creating, and shipping as the CTEs for which records containing KDEs would be required.

Traceability Program Records: In addition to requiring records of KDEs, the proposed rule would require persons who manufacture, process, pack or hold foods on the FTL to establish and maintain traceability program records.

Additional Requirements: Records must be maintained as either original paper records, electronic records, or true copies; they all must be legible and stored to prevent deterioration or loss. Traceability records must also be provided to FDA as soon as possible but no later than 24 hours after a request is made. An electronic sortable spreadsheet containing relevant traceability information must be provided to FDA within 24 hours of a request when necessary to assist FDA during an outbreak, recall or other threat to public health.

You can also access the proposed FDA rule that includes full descriptions of the rule and its key features.

It’s now more important than ever to monitor your products throughout the Supply Chain. Tracking location and critical environmental conditions in real time is critical to identifying the cause of any alerts. DeltaTrak’s real-time data loggers and FlashTrak supply chain cloud services and help you to maintain precision traceability.

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