FSMA Section 204 — the Food Traceability Rule under 21 CFR 1.1310 — requires lot-level traceability records for foods on the Food Traceability List (FTL). Compliance date is January 20, 2026. Tampa Bay specialty food manufacturers handling FTL foods need the records architecture in place now.
Persons who manufacture, process, pack, or hold foods on the FTL must maintain records of Key Data Elements (KDEs) for each Critical Tracking Event (CTE). The records must allow rapid identification and traceability of food through the supply chain.
FDA gets a 24-hour traceability sortable spreadsheet on request during a foodborne illness investigation.
FTL covers high-risk categories — soft cheeses, shell eggs, nut butters, cucumbers, herbs (fresh), leafy greens, melons, peppers, sprouts, tropical tree fruits, certain seafood (finfish, crustaceans, mollusks), ready-to-eat deli salads. The full list is published in the rule.
Tampa Bay seafood processors and fresh-cut produce processors are squarely covered.
Harvesting, cooling (for produce), initial packing, first land-based receiving (seafood), shipping, receiving, and transformation are the seven CTEs. Each requires specific KDEs.
Most specialty food manufacturers handling FTL inputs trigger the receiving, transformation, and shipping CTEs.
KDEs include the traceability lot code, location, date and time, quantity, traceability product description, and others depending on the CTE. The traceability lot code links inputs to outputs through transformation.
Records must be maintained electronically or on paper for at least two years and provided to FDA within 24 hours of request in a sortable electronic format.
Cooling is a CTE for produce. Cold-storage receiving and shipping are KDEs for any FTL food. Cold-chain temperature records are not strictly required by the traceability rule but are typically required by other regulations and by buyers — and sit alongside the traceability lot record.
ArcticOS™ centralizes both — traceability records and cold-chain temperature records — keyed to lot code.
Compliance date for the traceability rule is January 20, 2026. The architecture, the records system, and the staff training all need to be functional before then.
Tampa Bay specialty food manufacturers should already have implementation in progress.
Identify which inputs and outputs are on the FTL. Map CTEs across the operation. Define traceability lot codes. Set up electronic records. Train receiving, production, and shipping staff. Test sortable spreadsheet generation.
Expect FDA inspection focus on the traceability rule from 2026 forward.
January 20, 2026, for most provisions of the Food Traceability Rule under 21 CFR 1.1310.
Soft cheeses, shell eggs, nut butters, cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tropical tree fruits, finfish, crustaceans, mollusks, ready-to-eat deli salads — the full list is in the rule.
The traceability rule does not apply, but other FSMA records requirements (PCHF under 21 CFR 117) still do. Best practice is to maintain lot traceability across the operation regardless.
FDA can request a sortable electronic spreadsheet of traceability records; the rule requires production within 24 hours of request.
At least two years from the date of creation, in electronic or paper form. Most operations now keep records electronically.
Suncoast Cold Systems handles process refrigeration and cooling for specialty food manufacturers across Tampa, St. Petersburg, Clearwater, Brandon, Riverview, Temple Terrace, and Wesley Chapel. 24/7 dispatch. Licensed Class A A/C Contractor (FL #CAC1824642), EPA 608 Universal, OSHA 30 Construction.