PREVRA FSMA 204 Compliance: Understanding the FDA Food Traceability Rule
A practical breakdown of FSMA Section 204 for UK food businesses that export to or supply the US market. Covers Key Data Elements, record-keeping requirements, and the compliance timeline.
Why FSMA 204 matters for UK food exporters
FSMA Section 204 — the Food Traceability Rule — applies to anyone who manufactures, processes, packs, or holds foods on the FDA's Food Traceability List. If you export cheese, seafood, fresh produce, nut butters, or ready-to-eat deli items to the US, you are almost certainly in scope. Non-compliance carries the same weight as a food safety violation: mandatory recalls, import detention, and removal from the FDA's approved supplier lists.
Here is what surprises most UK operators: FSMA 204 is more prescriptive than EU or UK traceability law. Under retained EU regulation, you must identify your supplier and customer — one up, one down. FSMA 204 demands specific Key Data Elements at each Critical Tracking Event, including lot codes, location identifiers, and timestamps. You cannot comply with FSMA 204 by simply keeping your existing traceability records in better order — you need a different data structure.
Building your FSMA 204 compliance framework
Map your supply chain first. Identify every Critical Tracking Event — receiving, transforming, and shipping — for each product on the Food Traceability List. Then define which Key Data Elements must be captured at each point. The FDA requires records to be provided within 24 hours of a request, in a sortable electronic format. Paper records, PDFs, and static spreadsheets will not satisfy this requirement.
Digital SFBB with integrated traceability handles the data capture automatically. Lot codes are linked at receiving, carried through production batches, and tied to dispatch records. When the FDA or your US importer asks for a traceability report, you generate it in minutes rather than assembling it across three ring binders, two email inboxes, and a WhatsApp thread with your warehouse manager.
Pitfalls that derail FSMA 204 compliance efforts
First: assuming FSMA 204 does not apply because you sell through a distributor. The rule follows the product, not the commercial relationship. Second: confusing lot-level traceability with shipment-level traceability — you need both. Third: relying on your US importer to handle compliance — the obligation sits with the manufacturer, and the FDA can request records directly from foreign suppliers. Related: see our HACCP Plan Example guide to align your traceability with your hazard analysis framework.
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