The FDA Food Traceability Rule: New Record-Keeping for Listed Foods
In November 2022 the US FDA issued the final food traceability rule under section 204 of the Food Safety Modernization Act. Companies that handle foods on the Food Traceability List must keep additional records.
Key points
- The final rule was published in November 2022, with a compliance date of 20 January 2026.
- It applies to foods on the Food Traceability List, such as leafy greens, soft cheeses, shell eggs and certain seafood.
- Companies must record key data elements for critical tracking events and link them with a traceability lot code.
Who is affected
The rule applies to those who manufacture, process, pack or hold listed foods, including foreign companies whose products are exported to the United States. Exemptions exist, for example for some small producers and for foods that undergo a kill step.
What must be recorded
- Critical tracking events: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation
- Key data elements for each event
- A traceability lot code that follows the food through the chain
- A traceability plan describing the procedures
- Records that can be provided to the FDA within 24 hours of a request
How exporters should prepare
Check whether your products or ingredients are on the list, compare the required data with what your current traceability system records, and agree with your US customers how lot codes and data will be exchanged.