If you sell food into the US, FDA’s Food Traceability Final Rule, or known as FSMA 204, is the traceability upgrade you need on your radar. It creates additional traceability recordkeeping requirements for specific “higher-risk” foods on the Food Traceability List (FTL) and expects covered businesses to produce traceability information quickly when FDA requests it.
When will FSMA 204 come into effect?
FDA notes that it proposed extending the compliance date by 30 months to July 20, 2028. This date shall be treated the “must be ready” date to ensure your business is compliance ready to produce FDA-required traceability outputs quickly.
Who FSMA 204 applies to?
FSMA 204 applies to businesses that manufacture, process, pack, or hold foods on the FTL, unless an exemption applies.
The FTL includes a mix of produce and non-produce categories. Examples include cheeses, fresh cucumbers/leafy greens/tomatoes, shell eggs, ready-to-eat deli salads, crustaceans, and bivalve molluscan shellfish. The objectives of the rule is to allow for quicker identification and rapid removal of potentially dangerous food from the market, resulting in fewer foodborne illnesses and/or deaths.
The full list of products can be found here: FDA Food Traceability List.
Who are exempted from FSMA 204?
- Certain small producers
- Produce farms / farm activities that are not “covered farms” under Produce Safety (21 CFR part 112).
- Produce farms with ≤ $25,000 in produce sales.
- Shell egg producers with < 3,000 laying hens at a particular farm (for eggs produced at that farm).
- Other raw agricultural commodity producers with ≤ $25,000.
- Farms selling or donating direct to consumers
- Certain food produced and packaged on a farm
- Produce “rarely consumed raw” in 21 CFR 112.2(a)(1).
- Raw bivalve molluscan shellfish under specific programs
- Foods under USDA exclusive jurisdiction.
- Small retail food establishments and small restaurants with ≤ $250,000
- Food transporters
- Nonprofit food establishments
- Personal consumption
- Holding food on behalf of individual consumers (e.g., certain storage/handling services)
- Food for research or evaluation
What are the traceability rule requirements?
The two terms that drive the whole rule: CTEs and TLC
- CTEs (Critical Tracking Events) are the defined supply-chain events where FDA expects you to capture and keep traceability records for FTL foods. Think of them as required traceability “checkpoints” where product moves or changes in a meaningful way. Common CTEs include shipping, receiving, and transformation.
- TLCs (Traceability Lot Code) A TLC (Traceability Lot Code) is the lot identifier used for FSMA 204 traceability—a mark that ties together the records for a traceability lot.
When do you assign a TLC? In general, a TLC is assigned when you:
- initially pack certain FTL foods,
- conduct first land-based receiving for foods obtained from a fishing vessel, or
- transform an FTL food.
How TLC and CTEs connect: Once a food has a TLC, the traceability records you keep at each relevant CTE need to carry that TLC forward, so the chain stays linked during an investigation.
What is required exactly?
The FSMA 204 requires the food business who produces, receives or ships foods on the FTL to produce the KDEs (Key Data Elements) in a fast and sortable manner.
At each CTE, you must keep specific KDEs, namely the “who/what/when/where” details that prove what happened at that step. FDA even provides an Electronic Sortable Spreadsheet Template organized by CTE tabs and KDE columns to show what “good” can look like.
The “24-hour reality”
FSMA 204 is designed to speed up investigations. Your program should be built to respond fast in the event of a recall—including producing information in a usable format. FDA’s resources emphasize the need for electronic, sortable traceability outputs aligned to the rule’s CTE/KDE structure.
When an authorized FDA representative requests your FSMA 204 traceability records, you must make them available within 24 hours (or within another reasonable time FDA agrees to), plus any information needed to understand them.
While many companies have data, it’s generally scattered across receiving logs, ERP, warehouse paperwork, supplier COAs, and emailed BOLs. The goal here is building a system where you can assemble the traceability information quickly and consistently.
Traceability Plan: the document FDA will expect you to stand behind
FSMA 204 requires a Traceability Plan that describes, at minimum, how your organization:
- identifies FTL foods it handles,
- captures/maintains required records,
- assigns TLCs (if applicable),
- designates responsible contacts and procedures.
Final Thought
FSMA 204 isn’t just “more paperwork.” It’s a forced upgrade to monitor how high-risk foods move through the supply chain. Although the enforcement is delayed to July 20, 2028, the heavy lifting will be to getting your partners’ data to line up with yours—so starting early is a must. Traceability is critical to support market recall and withdrawal. Is your Recall Plan complete? Download the FSPCA V2 Recall Plan template here.
Authored by Sean Xia, Edited by Karine Lawrence
The US FDA has just released new guidance re: requirements for additional traceability records for certain foods. Find the guidance here.
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