FDA Traceability Rule Readiness Exercises Reveal Supply Chain Coordination Matters More than Technology
A series of tabletop exercises held by the U.S. Food and Drug Administration (FDA) revealed industry’s progress and challenges in meeting the requirements of the Food Traceability Rule, also known as Section 204(d) of the Food Safety Modernization Act (FSMA 204).
The current compliance date for the Food Traceability Rule is July 20, 2028. It was delayed by 30 months from its original compliance date (January 2026) to “afford covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements.”
Tabletop Exercises Overview
The exercises were held between March 9 and April 1, 2026, with voluntary participation from 15 companies spanning the supply chain, including processors, distributors, retail food establishments, and restaurants. Exercises represented six supply chain scenarios and centered on a request from FDA asking firms to provide traceability records in an electronic sortable spreadsheet within 24 hours, along with a Traceability Plan (if available). Participants were instructed that they could invite technology partners to support their efforts in these exercises. FDA analyzed submissions by assessing Key Data Element (KDE) availability for each Critical Tracking Event (CTE) that the firms performed.
Completion of the tabletop exercises fulfilled a Congressional directive to FDA.
FDA’s full report on the tabletop exercises can be accessed here.
Progress Driven by Supply Chain Coordination
According to FDA, the exercises demonstrated that meaningful progress is being made toward meeting the Food Traceability Rule requirements.
Most firms responded within 24 hours, and, more than any one technology, proactive supply chain coordination drove the strongest results. More specifically, participants used a wide range of tools—from traditional business records (e.g., invoices, purchase orders, bills of lading, and advance shipment notices) to Warehouse Management Systems, Enterprise Resource Planning, RFID tags, and GS1 barcodes. Larger firms tended to use more advanced data carriers (like RFID or 2D barcodes), but the technology itself was less determinative of success than whether supply chain partners had agreed on what data to collect, maintain, and share—and how. Even smaller and mid-sized firms had access to most of the required data through traditional business records.
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FDA also called Traceability Lot Code (TLC) and TLC source availability “encouraging." Although the TLC and TLC source proved to be the most challenging KDEs to capture across exercises, the TLC was available or inconsistently present in 80 percent of participants’ records, and the TLC source appeared in 73 percent of participants’ records.
Additionally, the agency underlined the helpfulness of Traceability Plans in testing readiness, although the majority of participants did not submit a plan. For those that did provide a plan, it proved useful in helping FDA interpret data accurately and efficiently. Developing a Traceability Plan prior to the compliance date could help firms test their readiness and assess any gaps, the agency suggested.
Certain Data Elements Still Need Work
The exercises also revealed challenges and gaps that remain to be resolved. For example, despite the "encouraging" TLC and TLC source availability, only 40 percent of participants’ records captured the properly assigned TLC across each CTE they performed, and 27 percent of participants’ records captured the complete TLC source for each CTE they performed. Moreover, participants showed uneven readiness for sharing TLC and TLC source information together, with some firms demonstrating the ability to capture and share one element but not the other.
FDA also underlined the need for initial packers to pay close attention to where a TLC is assigned and identified room for improvement regarding data quality and completeness across all CTEs performed by a firm.
Additionally, inconsistent buyer requirements created “significant challenges.” Because buyer requirements can vary by company and often go well beyond Food Traceability Rule requirements (including specific formatting for advance shipping notices, and, in some cases, mandatory case-by-case scanning for outbound shipping events at the distributor level), suppliers often must build custom solutions for each customer relationship. FDA called for greater standardization and harmonization between buyers and suppliers.
Continued FDA FSMA 204 Outreach and Additional Resources
The findings from the tabletop exercises will be used to inform future FDA outreach, education, and technical assistance efforts.
For example, FDA updated its Food Traceability Rule FAQ resource alongside the release of the Traceability Readiness Tabletop Exercises report.
Additionally, on June 15, FDA will hold a virtual town hall meeting on the challenges and opportunities related to the Food Traceability Rule’s lot-level tracking requirements, for which the agency has released a discussion paper, offering context and questions to guide stakeholder engagement. A second follow-up meeting is planned for November 6.
Another recently announced FSMA 204 resource is compliance training offered through the Food Safety Preventive Controls Alliance (FSPCA), designed to provide participants with the foundational knowledge needed to understand and comply with the Food Traceability Rule.
