Webinar
FSMA 204 in practice: lot-level traceability
FDA's Food Traceability Final Rule (21 CFR Part 1, Subpart S), mandated by FSMA Section 204, establishes additional recordkeeping for anyone who manufactures, processes, packs, or holds foods on the Food Traceability List. In March 2025 FDA announced a 30-month extension of the compliance date to January 20, 2028. The rule text itself was not changed — only the enforcement clock.
Rule citation and new compliance date
21 CFR Part 1, Subpart S (§§ 1.1300–1.1495). Final rule published November 21, 2022. Compliance was originally January 20, 2026; extended to January 20, 2028 per FDA's March 20, 2025 announcement.
The Food Traceability List (FTL)
Covers higher-risk foods including leafy greens, fresh herbs, cucumbers, melons, peppers, sprouts, tropical tree fruits, tomatoes, fresh-cut fruits and vegetables, shell eggs, nut butters, ready-to-eat deli salads, certain cheeses (soft, semi-soft, soft-ripened), finfish, smoked finfish, crustaceans, and bivalve molluscan shellfish. FDA maintains the authoritative list with commodity definitions.
Critical Tracking Events (CTEs)
Records are required at Harvesting, Cooling (pre-initial-packing), Initial Packing, First Land-Based Receiver (for seafood), Shipping, Receiving, and Transformation. Growing is not a CTE but has associated farm-level records.
Key Data Elements (KDEs)
Event-specific data: Traceability Lot Code (TLC), TLC source and source reference, quantity and unit of measure, product description, FDA-defined location identifiers (point of contact, ship-to, ship-from), date and time of event (for some CTEs), and reference document type and number. The TLC assigner is the entity that originates or transforms the lot.
The 24-hour sortable electronic spreadsheet
Per §1.1455(c)(3), firms must provide FDA with an electronic sortable spreadsheet of required traceability data within 24 hours of a request, covering the scope and date range FDA specifies. Paper records and PDFs are insufficient — the data must be producible in a sortable electronic form.
Exemptions and partial exemptions
Small producers, certain farm-to-consumer sales, foods receiving a kill step, raw agricultural commodities going directly to consumers, and some fishing-vessel operations. Exemptions are narrow — read §1.1305 carefully before relying on one.
Scope your workflow
Turn this into a working system.
Bring one audit you're dreading. We'll wire it against your ERP and QMS and hand back a working version.