What FSMA 204 Requires
If you manufacture, process, pack, or hold foods on the FDA’s Food Traceability List, you’re subject to enhanced recordkeeping requirements. The Food Traceability Rule requires capturing specific data points at specific moments in your supply chain, maintaining those records in a sortable format, and producing them within 24 hours of an FDA request.
The compliance deadline has been extended to July 20, 2028. The requirements themselves have not changed.
The Food Traceability List
The FDA’s list includes fresh-cut fruits and vegetables, shell eggs, nut butters, certain cheeses, fresh herbs, ready-to-eat deli salads, and specific seafood products. If your product contains an FTL food as an ingredient, the traceability requirements apply to that ingredient throughout your operation.
Critical Tracking Events
CTEs are the moments where traceability data must be captured: receiving, transformation, and shipping. Some operations may have additional CTEs — cold storage transfers, co-packing handoffs, or secondary processing steps.
Key Data Elements
KDEs are the specific data points at each CTE: traceability lot codes, product descriptions, quantities, units of measure, dates, and locations. The exact KDEs vary by event type.
Key Data Elements Explained
Receiving KDEs
When FTL food arrives: the traceability lot code from the supplier, product description with quantity and unit, receiving location, date received, lot code source, and a reference document.
Transformation KDEs
When you transform FTL food: the new traceability lot code for the output, date, location, quantity produced, and all input lot codes consumed.
Shipping KDEs
When FTL food leaves: lot code, product description with quantity, shipping location, date, recipient location, and reference document.
Identifying Your Critical Tracking Events
Receiving: Every time FTL food arrives. Review your ingredient list against the Food Traceability List. Flag every relevant ingredient.
Transformation: The test is whether the food has been meaningfully changed. Combining FTL ingredients into a new product is transformation. Slicing bread into a different shape is not.
Shipping: Every time FTL food leaves your facility. For DSD operations, every route, every stop, every delivery is a shipping event.
CTEs you might be missing: Facility-to-facility transfers, co-packing handoffs, third-party cold storage transfers.
Record-Keeping Requirements
Records must be maintained in electronic, sortable format. The FDA wants data they can filter, search, and cross-reference. Retention period: two years from the date of creation. Records must be producible within 24 hours of FDA request.
Building Your Compliance System
- Map your CTEs. Walk your operation from receiving to shipping.
- Identify FTL ingredients. Cross-reference your ingredient list with the FDA’s Food Traceability List.
- Gap analysis. For each CTE, determine which KDEs you’re already capturing and which you’re missing.
- Implement digital capture. Ensure KDEs are recorded electronically, linked by traceability lot codes.
- Run monthly mock traces. The best way to find gaps before an auditor does.
- Document your traceability plan. FSMA 204 requires a written plan describing your procedures.
How FlexiBake Helps
FlexiBake captures receiving KDEs when your team logs incoming ingredients. Transformation KDEs are recorded automatically when production batches link ingredient lots to finished product lots. Shipping KDEs are generated from confirmed deliveries. The traceability lot code chain is maintained without separate data entry.