US FSMA 204 · Fresh produce

FSMA 204 for fresh produce.

FDA Food Traceability Rule · foods on the Food Traceability List · compliance date extended to 20 July 2028.

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 204Food Traceability ListCTEs & KDEs20 Jul 2028Traceability lot code
What the rule requires

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 dates

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.

Rule final2022
Original compliance dateJan 2026
Extended compliance date20 Jul 2028
Retail buyer mandatesalready live
What to do now

Three moves that de-risk the deadline.

01 · Step

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.

02 · Step

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.

03 · Step

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.

How Aeroz fits

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.

FAQ

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 are how the records write themselves: scan-based capture beats clipboard-based capture on accuracy, speed and the 24-hour test.

Readiness audit

Know exactly where you stand — in 14 days.

A fixed-fee Aeroz audit maps your products against fsma 204 for produce requirements and returns a written readiness assessment, a data-mapping review, and a scoped pilot plan with cost and timeline.

Fixed fee 14-day written report No commitment to proceed