FDA outlines new materials to help industry meet requirements in traceability rule

The FDA has published new resources to help industry comply with the Food Traceability Rule. These include:

• A downloadable, electronic sortable spreadsheet template;
• Minor revisions to the Food Traceability List clarifying the status of previously frozen foods on the list, as well as a new FAQ summarizing the changes;
• A chart summarizing exemptions relevant to produce farms for both the Produce Safety Rule and the Food Traceability Rule;
• A supply chain example for sprouts; and
• New translated material about the Traceability Lot Code and the Traceability Plan.

In addition, the FDA has partnered with the Food Safety Preventive Controls Alliance (FSPCA) to develop training for the food industry on the Food Traceability Rule. Curriculum development has been initiated by a team including subject matter experts from FDA, industry and academia. The team is working to create training exercises to help food industry personnel to understand FDA’s Food Traceability Rule requirements. Training is anticipated to be available by mid-2025.

The Food Traceability Final Rule is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA).

The Food Traceability Rule requires persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to maintain and provide to their supply chain partners specific information – called Key Data Elements or KDEs – for certain Critical Tracking Events or CTEs in the food’s supply chain. This framework forms the foundation for effective and efficient tracing of food.

The following example will walk through the Critical Tracking Events in a supply chain where Key Data Elements are required.

Abbreviations used:

• Key Data Elements or KDEs

• Critical Tracking Events or CTEs

• Food Traceability List or FTL

• Traceability Lot Code or TLC

• Raw Agricultural Commodities or RACs

In this scenario, fresh sprouts are being packed by the sprout grower for sale at retail. Key Data Elements (KDEs) are required for the fresh sprouts at the points indicated in the graphic. Seeds are not on the Food Traceability List, so the seed grower, seed conditioner and seed supplier are not covered by the rule. As the initial packer of the sprouts, the sprouter must maintain certain KDEs related to the growing, conditioning, packing and supplying of the seeds. All entities in blue are covered by the rule and must maintain a Traceability Plan, in addition to the KDEs.

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