Answers · Updated

FSMA 204 food traceability: who is covered, the CTEs and the KDEs

Short answer

The FSMA 204 Food Traceability Rule (21 CFR Part 1 Subpart S) applies to anyone who manufactures, processes, packs or holds a food on the FDA Food Traceability List. Covered firms need a written traceability plan (21 CFR 1.1315) and must keep Key Data Elements (KDEs) for each Critical Tracking Event (CTE): harvesting and cooling (1.1325), initial packing (1.1330), first land-based receiving of seafood (1.1335), shipping (1.1340), receiving (1.1345) and transformation (1.1350). Records must reach FDA within 24 hours of a request (1.1455). FDA has said it will not enforce the rule before July 20, 2028.

Is your product covered?

Coverage depends on the FDA Food Traceability List, which includes foods such as soft cheeses, shell eggs, nut butters, fresh leafy greens, fresh herbs, tomatoes, peppers, cucumbers, melons, sprouts, fresh-cut fruits and vegetables, finfish, crustaceans, bivalve molluscs and refrigerated ready-to-eat deli salads. It also applies to foods that contain a listed food as an ingredient in the form listed. Check the official list linked below; exemptions are in 21 CFR 1.1305.

The traceability check does not decide whether a product is on the list. It answers the next question: which KDEs you must record for each event, with the section that requires them.

KDEs every lot record needs

  • Receiving (1.1345): traceability lot code, quantity and unit of measure, product description, immediate previous source, receiving location, date received, traceability lot code source, reference document type and number.
  • Shipping (1.1340): traceability lot code, quantity and unit, product description, immediate subsequent recipient, shipping location, ship date, traceability lot code source, reference document type and number.
  • Transformation (1.1350): the input lot codes with quantities used, the new traceability lot code, the transformation location as lot code source, completion date, product description, quantity and reference document.

Sources

Frequently Asked 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 Food Traceability Rule before July 20, 2028, and FDA has said it will follow that directive. The record requirements themselves did not change.
What are CTEs and KDEs in FSMA 204?
Critical Tracking Events are the supply chain steps the rule tracks: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation. Key Data Elements are the data you must record for each event, such as the traceability lot code, quantity, location descriptions and dates.
How fast must I give FDA traceability records?
Within 24 hours of a request, or a reasonable time FDA agrees to (21 CFR 1.1455(c)). When FDA asks in order to address a threat to public health, the CTE and KDE records for the foods and dates requested must generally be provided as an electronic sortable spreadsheet (1.1455(c)(3)); some small farms, retailers and restaurants may use another form.
Does FSMA 204 apply to every food?
No. It applies to foods on the Food Traceability List and foods containing them as ingredients in the listed form, with exemptions in 21 CFR 1.1305. Other foods remain under the general recordkeeping rules.

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