Guide · compliance
FSMA 204 and SFCR for potato, onion and sweet potato businesses
Whole potatoes, onions and sweet potatoes are not on the FDA Food Traceability List – but fresh-cut onions are, Canadian rules apply to every interprovincial or export load, and retailers ask for lot-level traceability regardless. Here is what applies, crop by crop.
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United States – what applies
| Product | FDA Food Traceability List (FSMA 204) | Produce Safety Rule |
|---|---|---|
| Whole potatoes | Not listed | Not covered – listed as rarely consumed raw (21 CFR 112.2(a)(1)) |
| Whole sweet potatoes | Not listed | Not covered – rarely consumed raw |
| Whole dry onions | Not listed | Covered |
| Fresh-cut onions (diced, sliced, peeled) | Covered – “fresh-cut vegetables other than leafy greens” | Covered at farm level |
| Fresh-cut potatoes / sweet potatoes | Exempt – rarely consumed raw produce is excluded (21 CFR 1.1305(e)) | Not covered |
FDA cannot enforce FSMA 204 before 20 July 2028. Retail and foodservice buyers already ask suppliers for lot codes on cases and ASNs, and a fast mock recall protects your customers either way.
Canada – Safe Food for Canadians Regulations (SFCR)
- Applies to most businesses that import, export or trade fresh fruits or vegetables between provinces or territories
- Safe Food for Canadians licence (required since 15 January 2019 for most businesses)
- Preventive controls and a written preventive control plan (PCP) – in force for fresh fruits or vegetables since 15 January 2020
- Traceability one step back (supplier, date received) and one step forward (customer, date shipped), plus common name, lot code and the name and address of who handled the food
- Records kept 2 years, in Canada, and provided to CFIA on request – electronic records in a single file that opens in standard software
- Lot code on consumer prepackaged fresh produce (enforced from 15 January 2021)
- Grades and grade names for interprovincial trade; DRC membership for interprovincial trade
How Producepak covers both countries
- Lot codes assigned at packing and printed on every bag, case and pallet
- One step back and one step forward recorded by scanning – no extra data entry
- FSMA 204 key data elements for fresh-cut onions, including transformation records
- Sortable spreadsheet export for FDA and single-file export for CFIA, in seconds
- Preventive control and QC records stored against each lot and bay
- Mock recalls: trace any lot forward and back in seconds
A mock recall in four steps
- Pick a lot Any bag, case or pallet lot code.
- Trace back Storage lot, grower, field, harvest date.
- Trace forward Every customer, load and date.
- Export Spreadsheet for FDA, CFIA or your customer.
Questions
We only pack whole potatoes in the US. Can we ignore traceability?
FSMA 204 does not list whole potatoes, but your buyers’ requirements, Canadian sales and recall protection still depend on lot-level records. Producepak keeps them as a by-product of normal work.
We dice onions for foodservice. What changes?
Fresh-cut onions are on the Food Traceability List. You assign a traceability lot code at transformation and keep the key data elements for receiving, transformation and shipping. Producepak records them as the job runs.
More guides for potato, onion and sweet potato businesses
- Storage, curing & shrink Temperatures, humidity, curing and how to stop shrink eating your margin.
- Grading, packout & grower pay Packout % by grower lot, grades, culls and settlements that add up.
- Bagging, labels & shipping Bag weights, bilingual Canadian labels, PTI cases and loads that are right.
- Processing & fresh-cut Peeled, diced and fresh-cut: yields, lot codes and by-products.
- AI reports & Pak-Bot Ask for a shrink chart, run the line by voice, print from anywhere.
- All potato, onion & sweet potato guides Start here.
Sources and further reading
- fda.gov – Food Traceability List
- ecfr.gov – 21 CFR 112.2, produce rarely consumed raw
- fda.gov – FSMA final rule on requirements for additional traceability records
- inspection.canada.ca – SFCR traceability requirements
- canada.ca – SFCR requirements in force for fresh fruits or vegetables (Jan 2020)
- inspection.canada.ca – fresh fruit or vegetable requirements (grades, DRC, imports)
- freshplaza.com – lot codes on prepackaged fresh produce in Canada
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.