FDA FSMA 204 Traceability: What Food Processors Need from Their Suppliers

## Preparing for FDA FSMA 204 (Food Traceability Rule) The FDA Food Safety Modernization Act (FSMA) Section 204 establishes additional traceability recordkeeping requirements for entities that manufacture, process, pack, or hold foods on the Food Traceability List (FTL). ### Critical Tracking Events (CTEs) Covered: - **Harvesting & Cooling** - **Initial Packing** - **Receiving** - **Transformation** (manufacturing / blending) - **Shipping** ### Key Data Elements (KDEs) Required from Suppliers: When receiving FTL ingredients (such as fresh leafy greens, nut butters, soft cheeses, or fresh-cut fruits), you must capture specific KDEs linked to the Traceability Lot Code (TLC): 1. Traceability Lot Code assigned by the supplier. 2. Source entity location identifier (GLN or FDA Food Facility Registration Number). 3. Date the commodity was harvested or packed. 4. Product description, category, and quantity received. ### Action Plan for QA & Procurement Teams: 1. Audit your current supplier register against the FDA Food Traceability List. 2. Update raw material specifications to require TLC linkage on all shipping notices and COAs. 3. Establish electronic records retention capable of generating an electronic sortable spreadsheet within 24 hours of an FDA inquiry.