FSMA 204 for fresh produce.
FSMA 204 for produce is the part of FDA's Food Traceability Rule that covers the fresh fruits and vegetables on the Food Traceability List, requiring key data at harvesting, cooling, packing, shipping and receiving.
The FDA's Food Traceability Rule requires anyone who manufactures, processes, packs or holds foods on the Food Traceability List — leafy greens, fresh-cut fruit and vegetables among them — to keep Key Data Elements for defined Critical Tracking Events, and hand FDA a sortable spreadsheet within 24 hours of a request. The compliance date has been extended to 20 July 2028; the recordkeeping build takes most companies longer than they expect.
FSMA 204 for produce, in three facts.
FDA Food Traceability Rule · foods on the Food Traceability List · compliance date extended to 20 July 2028.
Leafy greens, tomatoes, peppers, cucumbers, melons, fresh herbs, sprouts, tropical tree fruits and fresh-cut fruits and vegetables are on FDA's Food Traceability List.
Source: FDA, Food Traceability ListFDA will not enforce the Food Traceability Rule (FSMA section 204) before 20 July 2028.
Source: FDA, FSMA final rule on traceability recordsFirms covered by FSMA 204 must give FDA their traceability records within 24 hours of a request, as an electronic sortable spreadsheet in an outbreak or recall.
Source: 21 CFR Part 1, Subpart S
Every hop gets a record.
A traceability plan
A written plan describing how you assign traceability lot codes, where records live, and who FDA calls — the document an investigator asks for first.
KDEs at every CTE
Harvesting, cooling, initial packing, shipping, receiving, transformation: each Critical Tracking Event carries its Key Data Elements, linked by the traceability lot code.
The lot code that travels
The traceability lot code must persist as produce moves and transforms — the single thread FDA follows from a case of illness back to a field.
24 hours to a spreadsheet
On request, records must reach FDA as an electronic sortable spreadsheet within 24 hours. Paper in a filing cabinet fails this test by construction.
The timeline, as it stands.
FDA extended the compliance date to give the supply chain time to build. Retail buyers are not waiting — major retailers already push FSMA-grade data requirements into their produce suppliers.
Three moves that de-risk the deadline.
Map your CTEs honestly
Walk product from field to dock and list every event the rule defines. Most gaps hide at cooling and transformation, not at shipping.
Digitize the lot code
A lot code that lives on a carton sticker and a clipboard will not survive a 24-hour spreadsheet request. Capture it electronically at every hop.
Rehearse the FDA request
Pick a shipped lot at random and produce the full CTE/KDE chain within 24 hours. If the rehearsal fails, the real request will too.
The lot code, made machine-readable at every hop.
Aeroz carries the traceability lot code on a chip-read carrier at case or pallet level, so every CTE writes itself as an EPCIS 2.0 event on a scan — harvest to cooler to packer to DC. The 24-hour spreadsheet becomes an export, recalls narrow from "all romaine" to specific lots on specific pallets, and the same record answers the retail buyers already demanding it.
FSMA 204 for produce, answered.
Which produce is covered by FSMA 204?
Foods on FDA's Food Traceability List — including leafy greens, fresh-cut fruits and vegetables, cucumbers, herbs, melons, peppers, sprouts and tomatoes. If you grow, pack, process or hold them, the rule reaches you.
When is FSMA 204 compliance required?
FDA extended the compliance date to 20 July 2028 for the recordkeeping requirements. Large retail buyers are already imposing equivalent data requirements ahead of the date.
What is a traceability lot code?
The identifier you assign that links every Critical Tracking Event for a lot — assigned at initial packing or transformation and carried through the chain. It is the thread FDA pulls in an outbreak.
Does FSMA 204 require RFID or chips?
No — the rule requires records, not a specific technology. Chips can make the records write themselves: scan-based capture beats clipboard-based capture on accuracy, speed and the 24-hour test.
From the Aeroz blog
- The Fallacy of the Batch Perimeter: Why Modern Supply Chains Require Item-Level Serialization
- 19 Million Eggs, One Carton Code: The 2026 Shell Egg Recall
More answers: FSMA 204 questions in the compliance FAQ
Know exactly where you stand — in 14 days.
A fixed-fee Aeroz audit maps your products against FSMA 204 requirements for produce and returns a written readiness assessment, a data-mapping review, and a scoped pilot plan with cost and timeline.