FSMA Section 204 directs FDA to require additional traceability records for higher-risk foods on the Food Traceability List, implemented in 21 CFR Part 1, Subpart S.
Detailed Definition
The food traceability rule requires companies that manufacture, process, pack or hold foods on FDA's Food Traceability List to keep key data elements for critical tracking events such as harvesting, cooling, initial packing, shipping, receiving and transformation. Records link to a traceability lot code, and firms must keep a traceability plan and provide records to FDA within 24 hours of a request. The rule is about food lots, not pallets, though pallet labels such as a GS1 SSCC can help carry the data.
Where pallets fit in food traceability
A pallet is a convenient unit for moving traceability data. When a shipping pallet carries a single traceability lot, its label and advance ship notice can tie the pallet to that lot code. Mixed pallets with several lots need each lot recorded. The rule does not require a specific barcode or system, but many companies use GS1 standards such as GS1-128 labels and advance ship notices to pass data between trading partners.
Practical steps for shippers and receivers
- Check FDA's Food Traceability List to see whether your foods are covered.
- Map the critical tracking events in your own operation.
- Agree with customers and suppliers on how lot codes and key data elements will be shared.
- Make sure relabeling or repalletizing in the warehouse does not break the link to lot codes.
- Check FDA's website for the current compliance date, since it has been changed before.
Key terms in the traceability rule
A traceability lot code identifies a specific lot of food. Critical tracking events are the points in the supply chain where records are required. Key data elements are the details recorded at each event, such as quantity, location, date and the lot code. A traceability plan describes how a company keeps these records and finds them when FDA asks.
Authoritative Sources
- FDA Food Safety Modernization Act (FSMA): FDA's information hub for the Food Safety Modernization Act and its rules, including the Sanitary Transportation of Human and Animal Food rule and the food traceability rule.
Related Glossary Terms
Frequently Asked Questions
Does the food traceability rule require tracking every pallet?
No. The rule requires records tied to traceability lot codes for foods on the Food Traceability List, at specific critical tracking events. It does not require a serial number on each pallet. Even so, pallet labels and shipping records are often the most practical place to capture shipping and receiving data, so many companies design their systems around the pallet while the legal unit remains the food lot.
What happens if a pallet is broken down and rebuilt in a warehouse?
If cases of covered foods are split across new pallets, the traceability lot codes on those cases still need to be recorded when they ship. Repalletizing alone does not usually create a new lot code; a new one is generally assigned when food is transformed, for example repacked or relabeled. Warehouses should keep case labels readable and make sure each new pallet's shipping record lists every lot it contains.