The FDA’s new Traceability Rule, designed to help FDA to quickly solve foodborne illness outbreaks, becomes effective in early 2026. As the deadline looms closer, most companies subject to the rule find themselves struggling to figure out how to best achieve compliance. This has been especially true for retailers and restaurants (“retailers”) who, under the rule as currently drafted, will have to collect and maintain enhanced traceability records for all incoming high-risk foods identified on FDA’s Food Traceability List (“FTL”).

Some retailers, however, are arguing that the rule’s requirements, coupled with the sheer volume and complexity of incoming products subject to the rule, make achieving and maintaining compliance too onerous. On March 6, in an effort to refine and address the compliance challenges posed by the rule, U.S. Reps. Scott Franklin (R-Fla.) and Sanford Bishop (D-Ga.) introduced the Food Traceability Enhancement Act (H.R. 7563). This bill reportedly aims to facilitate a more practical and less burdensome approach to food traceability, ensuring that the safety and integrity of the food supply chain are maintained without imposing undue hardships on retailers.

At the heart of the legislation is an attempt to refine the rule’s recordkeeping requirements applicable to retailers. Recognizing the onerous nature of the two-year record retention mandate, the bill proposes a reduction to a more manageable one-year period. This change would not only alleviate the administrative burden on food businesses, but also seek to achieve a pragmatic balance between operational efficiency and the ultimate need for traceability.

Pursuant to the Food Traceability Rule, restaurants, retail food establishments and their warehouses are required to maintain and provide traceability lot codes when requested to FDA in order to help the agency quickly identify the original source of foodborne illness outbreaks. The Food Traceability Enhancement Act (which would not change the rule’s requirements applicable to the remainder of the supply chain), seeks to temporarily eliminate this retail requirement, thereby simplifying the compliance landscape or retailers in exchange for time to conduct pilot projects designed to test the effectiveness of the new traceability system without imposing new requirements on retailers.

Under the new bill, FDA would be tasked with conducting at least three pilot studies in collaboration with the food industry, focusing on retailers and warehouses. These pilots would be designed to assess the efficacy of outbreak investigations without reliance on traceability lot code information and to explore the effectiveness of lower-cost tracing technologies. Each pilot would concentrate on a different commodity from the FTL, evaluating various segments of the food supply chain.

Following the completion of the pilots, the FDA would be required to submit a report to Congress, outlining its findings and offering recommendations aimed to minimize disruptions in the supply chain, ensure the continued availability and diversity of food products, reduce compliance burdens for small businesses, and identify viable low-cost tracing technologies. This report, due within 18 months of the bill's enactment, would likely play an important role in informing potential future revisions to the rule based on the data collected.

To allow time for the pilot studies, the bill proposes an extension of the Rule's compliance deadline to at least two years following the conclusion of the pilots, providing stakeholders with ample time to adapt to any resulting changes. Additionally, the bill calls for enhanced transparency and collaboration by requiring the FDA to report to Congress on any legal or other barriers to information sharing regarding foodborne illness outbreak investigations within 90 days of the bill’s enactment.

Whether the Food Traceability Enhancement Act passes or not remains to be seen. On the one hand, the bill clearly aims to ensure the vitality and resilience of the food supply chain arguably without compromising food safety, which might logically be east for lawmakers to support. On the other hand, FDA and others will likely argue that, the bill would, in essence, decrease the effectiveness of FDA’s Traceability Rule by lessening the amount of information available to investigators working to solve outbreaks. In any event, we will continue to watch the progress of the new legislation with interest, and will keep a keen eye on its potential effect on the industry.

Tracking Potential Changes to FDA's Traceability Rule

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