New Deadline Alert: FDA Intends to Push Food Traceability Rule (FSMA 204) Back 30 Months

On March 20, 2025, the United States Food and Drug Administration (FDA) announced its intent to extend the compliance date for the Food Traceability Rule (FSMA 204) by 30 months. In a press release, the FDA stated that the extension will ensure that food businesses have sufficient time to adapt their technology systems and record-keeping practices to meet the traceability standards. 

A critical component of the Food Safety Modernization Act, FSMA 204 (so named because it is the rule that implements Section 204(d) of the FSMA) sets forth the specific requirements for recordkeeping and reporting in connection with food traceability with the goal of enhancing the FDA’s ability to track and trace food products in the event of a foodborne illness outbreak. The rule requires that certain food facilities and farms that manufacture, process, pack or hold foods listed on the Food Traceability List, comply with the requirements. Items on the list include cheese, eggs, butter, fresh produce, finfish, crustaceans, molluscan shellfish and ready-to-eat deli salads. Based on the broad list of food, companies that could fall under FSMA 204 include manufacturing plants, farms, wholesalers, distributors, retail food establishments that sell directly to consumers, grocers and even restaurants. The rule identifies limited exemptions to those who must comply with the rule, including companies that fall exclusively under USDA jurisdiction and Small Retail Food Establishments (RFEs) as defined by the rule. There are also product-specific exemptions, for example, produce that is “rarely consumed raw,” such as potatoes and more.   

Companies covered by the rule must maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs), and establish a traceability plan that outlines procedures for compliance. Importantly, FSMA requires covered entities to share information with other entities in their supply chain. The purpose of recordkeeping and tracking is to allow for quicker identification of the source of contamination and to improve the overall safety of the food supply chain.

While the FDA’s announcement must be finalized via a proposed rule in the Federal Register to become official, the new deadline is July 20, 2028. Companies that fall within Rule 204 reporting requirements will now have an additional 30 months to come into compliance with the regulation. 

Compliance with the rule requires coordination between all parties in the food chain. In order to have accurate data to report, a company needs to receive correct data from the previous company handling the food. For a restaurant, grocer or retail food establishment to have reliable data, it needs to collect and maintain accurate data from the distributors, and the distributors need to collect and maintain accurate data from the suppliers. Companies have different levels of technical abilities and data collection that will require revisions from multiple functions of an operation, including food safety and quality, procurement, distribution and even IT.  

The FDA recognizes that companies must rely on each other for full compliance. The FDA’s decision to extend the compliance deadline appears to have been born out of concern that many of the entities likely to be covered by the rule were simply not ready. To the extent that a few entities were prepared to meet the law’s requirements, this was rendered moot by supply chain partners that were not similarly prepared.

What Should the Food Industry Keep in Mind?

While this may seem like a lengthy extension to some, it may be just enough time for covered entities to create a traceability plan and come into compliance with the Rule. Companies that are ready to comply with Rule 204 should view this extension as an opportunity to fine-tune their systems. 

For more information or assistance with navigating FSMA 204 compliance, please do not hesitate to contact your primary RJO attorney. You can also reach out to the Retail Trade practice co-chair Shareholder Alecia Cotton (acotton@rjo.com), Shareholder Jon-Erik Magnus (jmagnus@rjo.com) or Ruby Zapien (rzapien@rjo.com).