The FDA Food Safety Modernization Act (FSMA) Section 204 Food Traceability Rule requires food companies to maintain enhanced traceability records for foods on the Food Traceability List (FTL). Compliance is required by January 20, 2026 (extended to 2027 for some entities).
Food Traceability List (FTL)
The FTL includes high-risk foods: fresh leafy greens; fresh herbs; tomatoes; peppers; cucumbers; melons; tropical tree fruits; fresh shell eggs; nut butters; ready-to-eat deli salads; soft cheeses; and finfish, crustaceans, and bivalve molluscan shellfish. Companies handling FTL foods must maintain enhanced traceability records.
Critical Tracking Events (CTEs)
Companies must maintain records at six Critical Tracking Events: growing (for farms); receiving; transforming; creating; shipping; and harvesting/cooling (for farms and fishing vessels). At each CTE, specific Key Data Elements (KDEs) must be recorded and retained for 2 years.
Key Data Elements (KDEs)
KDEs vary by CTE but typically include: Traceability Lot Code (TLC); TLC source; quantity and unit of measure; product description; location description; date; and reference document type and number. The TLC is the critical linking element that connects records across the supply chain.
Traceability Lot Code (TLC)
The TLC is a unique identifier assigned to a food at the point of creation or first receipt. The TLC must be maintained throughout the supply chain and included on all shipping documents. The TLC enables rapid tracing of a food product from farm to consumer in the event of a food safety incident.