FSMA 204 — the Food Traceability Final Rule under 21 CFR 1 Subpart S — requires operators handling Food Traceability List (FTL) commodities to capture and maintain Key Data Elements at each Critical Tracking Event in the chain. For Tampa Bay produce operations handling listed leafy greens, herbs, melons, peppers, sprouts, tropical tree fruit, fresh-cut produce, and certain ready-to-eat foods, the compliance date is January 20, 2026 — already in effect by the time you read this. Cold-storage operators are squarely in scope.
FSMA 204 covers any person manufacturing, processing, packing, or holding any food on the Food Traceability List for distribution in the U.S. Cold-storage holding is explicitly a Critical Tracking Event. Operators must capture and retain Key Data Elements (KDEs) for each event and provide them to FDA within 24 hours on request.
Florida operators handling listed commodities — and the FTL includes most leafy greens, fresh herbs, cucumbers, tomatoes (under specific conditions), peppers, melons, sprouts, ready-to-eat tropical tree fruits, and fresh-cut produce — are in scope regardless of operation size unless qualifying for a narrow exemption.
For a holding event (cold storage), the rule requires the operator to capture: traceability lot code, location identifier, date received, date released, quantity, and the immediately previous and subsequent supply chain links. The lot code travels with the product and must be linkable across the chain.
For a Tampa Bay packing-shed operator pulling listed product into a walk-in for staging, this means receiving each lot under its existing traceability lot code, recording the entry into the cold room, recording the exit, and forwarding the same lot code on the outbound documentation.
The traceability lot code does not change at a holding step. If lot ABC123 entered your cooler, it must leave as lot ABC123. Operations that re-pack into smaller cases must establish new lot codes that link back to the source lot via the Traceability Lot Code Source.
This is where most non-compliance gets discovered. A wholesale florist or produce hub re-packing into mixed cases without lot-code linkage breaks the chain. Build the linkage into the WMS or pack-line software before peak season, not during.
Records must be available to FDA within 24 hours of a request, in an electronic spreadsheet (sortable) format. Two-year retention. The 24-hour clock starts when FDA asks, not when you receive the email — operations are expected to have records pulled and ready, not to start building the export when the request lands.
Operations relying on paper logs or fragmented spreadsheets will struggle to meet 24 hours during a real outbreak investigation. ArcticOS-style integrated portals or comparable WMS systems with KDE export are the practical compliance posture.
A pure holding event (lot enters cooler, rests, leaves cooler unchanged) is the simplest KDE capture. A consolidation event (multiple lots into one outbound order) requires the outbound documentation to identify each contributing lot. A re-packing event (case to retail clamshell) requires new lot codes linked to source.
Cold-storage operators rarely run only pure holding events; the consolidation step is universal in floral wholesale and produce hubs. Map your operation's workflow against the KDE requirements for each event type.
An FSMA 204 inspection — typically combined with a Produce Safety Rule audit — looks at the records system first. An inspector picks a random lot from the cooler, asks for the source documentation, and asks for the disposition. Then they pick a random outbound shipment and ask the same question in the other direction.
Operations that pass have run mock inspections internally and timed the lot-pull-and-export workflow. Operations that fail have records that exist but cannot be retrieved fast enough.
Map every product line against the FTL. For listed commodities, audit the receiving, holding, and outbound workflow against the KDE list. Implement lot-code capture at the receiving dock and at the outbound pack-out. Test the 24-hour export with a mock request quarterly. Train the receiving team — they are the first line of capture and the most common failure point.
Yes if you manufacture, process, pack, or hold any commodity on the Food Traceability List. The FTL includes most leafy greens, fresh herbs, cucumbers, peppers, melons, sprouts, ready-to-eat tropical tree fruit, and fresh-cut produce. The rule applies regardless of size unless qualifying for a narrow exemption.
January 20, 2026. The rule is now in effect. Operations that have not implemented KDE capture are operating non-compliantly and exposed to enforcement on the first inspection.
No. FSMA 204 covers food on the FTL. Cut flowers and ornamental floral are not food and are not on the FTL. Floral wholesale operates under PACA and FDACS Bureau of Food Distribution rules.
In a sortable electronic spreadsheet format. Test the export workflow before the inspection — most operations discover their records system cannot produce a clean export under time pressure. Mock a request quarterly.
Suncoast Cold Systems services floral and agricultural refrigeration across Tampa, St. Petersburg, Clearwater, Brandon, Riverview, Temple Terrace, and Wesley Chapel — retail floral display coolers, wholesale floral DC walk-ins, ag packing-shed cold rooms, hydrocoolers, and forced-air cooling tunnels. 24/7 dispatch. Licensed Class A A/C Contractor (FL #CAC1824642), EPA 608 Universal, OSHA 30 Construction.
The PSR foundation under FSMA — what it requires of cold-side equipment.
State and federal rules beyond FSMA for produce and floral cold storage.
Diagnostics for the listed commodities most exposed to traceability issues.