The FSMA 204 rule—the Food Traceability Final Rule from the FDA—mandates stricter recordkeeping for certain high-risk foods to enable faster identification and removal during outbreaks. The rule won’t be strictly enforced until July 2028 but many grocers and retailers, such as Kroger and Walmart, are already requiring compliance.

Those foods which are subject to the FSMA 204 mandate are officially known as the Food Traceability List (FTL) and include items such as many kinds of produce, seafood, dairy foods, eggs, and other processed foods. The foods were selected by the FDA based on a “Risk-Ranking Model” that evaluates factors like outbreak frequency, illness severity and the likelihood for contamination.

While the spirit of the rule became operational in January 2026 under the original compliance date, the regulatory landscape shifted in late 2025 when FDA enforcement was delayed by 30 months until July 20, 2028. The extension was granted to allow the complex web of 3PLs, manufacturers and retailers more time to synchronize their digital systems and data-sharing protocols.

Despite this delay, the call to comply to FSMA 204 remains urgent. Here is what Midwest-based 3PLs, warehousing providers, and other food handlers need to know about the new rule from the operational perspective:

1.  24-hour digital mandate

The FDA requires that requested records—specifically an electronic sortable spreadsheet—be provided within 24 hours. For 3PLs still relying on paper BOLs or static PDFs, this is a massive operational hurdle. In 2026, many 3PLs are searching for software such as “interoperable middleware” that can pull data from disparate systems (such as a WMS) into a single FDA-ready format. 

2. Managing Critical Tracking Events for “holders”

Under FSMA 204, critical tracking events (CTEs) are key points in the supply chain where data surrounding food on the FTL must be captured, such as harvesting, receiving, transforming (think manufacturing, processing, repackaging, etc.), and shipping.

Warehouses and 3PLs are classified as “holders” given they store foods. Under FSMA 204, holders of FTL foods must manage CTEs by establishing, recording, and maintaining specific Key Data Elements (KDEs) for receiving and shipping. KDEs may include specific information to record at each CTE, like product descriptions, quantities, lot codes, and dates.

Holders must assign, record, and share a Traceability Lot Code (TLC) to the next party in the supply chain, along with related receiving and shipping data. If a 3PL fails to capture the TLC upon receipt, the entire chain is broken.

As suggested earlier, 3PLs must also provide these electronic records to the FDA within 24 hours of a request, and full compliance is required by July 2028.

3. Mixed loads add complexity for 3PLs

If all of this isn’t difficult enough, many Midwest consolidation centers and 3PLs often handle mixed loads, such as pallets containing both FSMA-regulated leafy greens and non-regulated shelf-stable items. As a result, 3PLs are struggling with “data bloat” in figuring out how to track lot-level data for only 20% of their inventory without slowing down the throughput of the other 80%. 

In response, some 3PLs are segmenting their WMS to only trigger TLC (lot code) capture for specific SKUs on the FTL (food traceability list) but this requires precision scanning at the point of receiving. Other holders are moving toward universal traceability where they treat 100% of their inventory as if it were on the FTL.

To maintain throughput, some 3PLs are even pushing the data burden further upstream, requiring suppliers to send Advanced Shipping Notices (ASNs) or use EPCIS (Electronic Product Code Information Services) files. This requires more sophisticated workflows such as implementing single “license plates”: using serialized shipping container codes (SSCC) to uniquely identify pallets and cartons which enables fast, accurate and automated tracking without manual break-downs of pallets.

4.  Liability shifting in contract clauses

The private-sector response to the FSMA 204 rule change is already underway. While the FDA doesn’t mandate indemnification, shippers and retailers are using the 2026-2028 window to mitigate their own risk. For 3PLs, the primary liability shift goes from general food safety to data integrity. If a 3PL’s data gap leads to a broad, uncontained recall because specific lots couldn’t be identified, shippers are using indemnification clauses to recover the cost of lost inventory and brand damage, fines or other fees.

Because the FDA can demand an electronic sortable spreadsheet of all KDEs within 24 hours during an outbreak, shippers are pushing that liability onto the 3PL. As suggested above in item 2, under Critical Tracking Events, if a 3PL cannot produce the required KDEs (key data elements) within 24 hours of an outbreak, they risk being held liable for the entire cost of a broad recall, rather than a targeted one.

As a result, shippers are now inserting traceability indemnification clauses in their contracts to hold the 3PL liable if they fail to maintain or transmit the required traceability data. This means if a 3PL’s system fails to record a TLC (lot code), and the shipper has to recall an entire region’s stock because they can’t prove which pallets were safe, the 3PL is being held financially responsible for that uncontained loss.

While the new FDA Food Traceability rule, known as FSMA 204, goes a long way to support public safety to ensure faster identification and removal of select foods during outbreaks, compliance requires even more rigorous controls and handling practices for all parties in the supply chain.

For shippers, food companies and distributors requiring a Midwest certified food-grade warehousing provider, look to Worley Warehousing for worldclass food-grade storage, handling and transportation solutions. We bring customers the benefits of rigorous safety and quality control processes and the highest cleanliness and sanitation standards. This commitment to the food industry is seen in our consistently Superior ratings by AIB International, and our adherence to other certification bodies.