FSMA 204: the FDA Food Traceability Rule for produce
FDA's Food Traceability Rule requires extra records for high-risk foods – including leafy greens, tomatoes, peppers, cucumbers, melons and fresh-cut produce – so outbreaks can be traced in hours instead of weeks.
What the rule requires
- Keep key data elements (KDEs) for each critical tracking event (CTE): harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation
- Assign a traceability lot code (TLC) at initial packing or transformation, and link every KDE to it
- Pass the TLC and related KDEs to your customer with each shipment
- Maintain a written traceability plan, with a point of contact – and a farm map for growers
- Provide records to FDA within 24 hours of a request, including an electronic sortable spreadsheet when required
Source: FDA – FSMA Final Rule on Requirements for Additional Traceability Records and 21 CFR Part 1 Subpart S.
Produce on the Food Traceability List
| Category | Examples |
|---|---|
| Leafy greens (incl. fresh-cut) | Lettuce, spinach, kale, arugula, chard, spring mix |
| Fresh herbs | Parsley, cilantro, basil |
| Cucumbers, peppers, tomatoes | Fresh, whole |
| Melons | Cantaloupe, honeydew, watermelon |
| Tropical tree fruits | Mango, papaya, guava |
| Sprouts | All types |
| Fresh-cut fruits & vegetables | Any fresh-cut product |
Always confirm against FDA's current Food Traceability List; exemptions apply to some small farms and businesses.
How Producepak and CHAIN-TRACE cover FSMA 204
- TLCs assigned automatically at packing and transformation
- KDEs captured as part of receiving, packing and shipping – no separate log
- TLC and KDEs sent to customers on the BOL, invoice, labels or EDI, and through the CHAIN-TRACE QR
- Sortable spreadsheet of any lot's history in seconds
- Mock recalls on demand to prove your 24-hour response
Questions
When do I have to comply with FSMA 204?
The original compliance date was January 20, 2026. Congress directed FDA not to enforce the rule before July 20, 2028, and FDA has proposed moving the compliance date to July 20, 2028. Check the FDA page for the current status.
Which produce is covered?
Foods on FDA's Food Traceability List, including fresh cucumbers, fresh herbs, leafy greens (including fresh-cut), melons, peppers, sprouts, tomatoes, tropical tree fruits, and fresh-cut fruits and vegetables.
Do I need special software?
The rule doesn't require software, but you must produce an electronic sortable spreadsheet of records within 24 hours on request. Doing that from paper is impractical for most packers.