FSMA 204 guide
FSMA 204: a guide to preparation with Producepak
The FDA cannot enforce the Food Traceability Rule before 20 July 2028, but buyers already ask for lot-level data. This guide takes a fresh produce business from "where do we start" to a tested, documented traceability system in eight steps – most of them done inside Producepak during normal setup.
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24 h FDA traceability spreadsheet from one search
Eight steps to readiness
- Check what you handle List every product and compare it with the FDA Food Traceability List: cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits and fresh-cut fruits and vegetables. In Producepak each item is flagged "FTL" once; reports and labels then treat it differently.
- Map your critical tracking events Write down where harvesting, cooling, initial packing, shipping, receiving and transformation (repack, fresh-cut) happen in your business and who does them. Producepak locations, cool rooms and packing lines are set up to match.
- Decide the traceability lot code If you initially pack or transform an FTL food, you assign the TLC. Choose a format (for example site + date + run) and print it on every case – Producepak generates it and puts it in the GS1-128 barcode on the PTI label.
- Write the traceability plan Procedures for keeping records, how FTL foods are identified, how TLCs are assigned, a point of contact and – for farms – a field map with coordinates. Producepak holds the plan document and the field map next to the records it describes.
- Connect suppliers and customers Ask suppliers to send TLCs on their documents or ASNs; agree with customers how you send yours (case label, ASN/EDI 856, bill of lading). Producepak reads supplier lot codes at receiving and sends yours on every shipment.
- Train the team on scanning Records are only complete if every receipt, pack-out and dispatch is scanned. Producepak runs on phones, tablets and scanners; a short session per role is usually enough.
- Run mock recalls Pick a lot, run a forward and backward trace and export the sortable spreadsheet. Time it and fix gaps. Repeat quarterly; keep the results for auditors.
- Review every year New products, sites, suppliers or customers change the plan. Update it at least once a year and keep records for 2 years.
A timeline to 20 July 2028
| When | What to have done |
|---|---|
| Now – Q1 2027 | Steps 1–3: FTL check, event map, lot code format; Producepak set up with items, sites and labels |
| Q2 – Q3 2027 | Steps 4–6: traceability plan written, suppliers and customers sending lot codes, team scanning every event |
| Q4 2027 | First full mock recall; fix gaps; second mock recall |
| H1 2028 | Quarterly mock recalls, plan reviewed, records retention (2 years) confirmed |
| 20 July 2028 | FDA enforcement date set by Congress (Sec. 780, Public Law 119-37) |
What Producepak sets up for you
- FTL flag per item and per customer requirement
- Locations: fields with coordinates, cool rooms, packing lines, docks
- TLC format and PTI/GS1-128 case labels
- Traceability plan template filled with your setup
- Mock recall report and FDA spreadsheet export
What you decide
- Which products are on the list (with your food safety lead)
- Who is the traceability contact
- Which suppliers must send lot codes
- How often you run mock recalls
Questions
Is the deadline final?
The rule is in force; Congress barred FDA from using funds to enforce it before 20 July 2028 (Sec. 780, Public Law 119-37). FDA’s own proposed extension to the same date was published on 7 August 2025. Check the FDA page before planning around any other date.
We only grow – does this apply?
Farms that grow FTL foods keep harvesting (and cooling) records and need a farm map in the plan. Some small farms are exempt or partly exempt; FDA has an online exemption tool.
How long are records kept?
Two years, and they must reach FDA within 24 hours of a request.
Sources and further reading
- fda.gov – FSMA final rule on requirements for additional traceability records
- fda.gov – Food Traceability List
- foodsafetynews.com – the traceability rule and the 2028 enforcement date (Oct 2026)
- ifas.ufl.edu – Traceability key takeaways for produce (University of Florida IFAS, PDF)
- freshproduce.com – IFPA FSMA 204 resources
- producepak.com – Producepak Fresh Produce App specifications (PDF)
See Producepak running on your product
Watch the short video, then book a live demonstration with a fresh produce consultant who knows US packhouses, PTI labels and FSMA 204.