FSMA 204 Traceability
21 CFR Part 1 Subpart S — Requirements for Additional Traceability Records for Certain Foods (FSMA §204)
Topic : Supply chain due diligence · Level : National
Today
Rule in force; P.L. 119-37 bars enforcement before 20 Jul 2028. FDA delay rule not final; lot-level flexibility under review.
Summary
FDA's food traceability rule requires firms handling listed high-risk foods to keep lot-level records along the chain. Compliance has been moved to 20 July 2028, and FDA is studying more flexibility.
Who is concerned
- Turnover
- not specified (small-business exemptions apply)
- Employees
- non précisé
- Listed company
- cotées et non cotées
- Sectors
- Fresh produce
- Seafood
- Eggs and soft cheeses
- Nut butters
- Triggering activities
- Making, packing or holding FTL foods
- Exporting FTL foods to the US
- Extraterritorial reach
- Yes
Applies to foreign facilities that make, pack or hold Food Traceability List foods for US consumption.
- Examples
- US grocery retailer
- Chinese seafood processor exporting to US
- Fresh-cut produce packer
What the law requires
- Keep Key Data Elements for each Critical Tracking Event
- Assign traceability lot codes at packing or transformation
- Maintain a written traceability plan
- Provide a sortable spreadsheet to FDA within 24 hours on request
Penalties
No new fine schedule; enforcement under FD&C Act (refusal of import, detention, injunction, prosecution).
What this changes for a supplier in China
Chinese exporters of seafood, produce or other FTL foods must keep lot-level traceability data and share it with US customers by July 2028.
Expected evidence
- Traceability lot codes per shipment
- KDE records for harvest, packing, shipping
- Written traceability plan
Tiers : Tier 1-2