The U.S. Food and Drug Administration (FDA) has shared its intention to extend the compliance date for the Food Traceability Rule (FSMA 204) by 30 months.
The FDA will extend the compliance date using appropriate procedures at a later time, including publishing a proposed rule in the Federal Register.
The FDA stated that it is “committed to successful implementation of the full requirements of the final rule,” as they will allow for faster identification and removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Accordingly, the compliance date extension does not amend the requirements of the final rule, which will improve food safety and protect public health.
Instead, the compliance date extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements – providing FDA and consumers with greater transparency and food safety.
The final rule establishes additional traceability recordkeeping requirements (beyond what is already required in current regulations) for persons who manufacture, process, pack or hold foods on the Food Traceability List. The final rule requires a higher degree of coordination between members of the food industry than has been required in the past. Therefore, to achieve the full public health benefits of the final rule, all covered entities must be in compliance.
Even those few entities who are well positioned to meet the final rule’s requirements by January 2026 have expressed concern about the timeline, in part because of their reliance on receiving accurate data from their supply chain partners, who are not similarly situated. Therefore, FDA intends to allow industry additional time, across all regulated sectors, to fully implement the final rule’s requirements.
ReposiTrak Chairman and CEO Randy Fields echoed this sentiment, sharing, “For the last two years, ReposiTrak has been anticipating and encouraging the FDA to push back the compliance deadline for FSMA Section 204 in the interest of the industry. Traceability requires not just data but good data. Because traceability is complex and the biggest supply chain collaboration in the history of the food industry, every trading partner needs to learn how to collect, analyze, manage and share that quality data so that the next participant in the supply chain doesn’t have a garbage-in-garbage-out problem. Our team knows how beneficial a move like this is for the industry, and we welcome the FDA providing some additional time for companies to successfully implement traceability systems.
“ReposiTrak also commends the FDA for maintaining the essence of traceability. Importantly, the FDA is only moving the deadline to accommodate tens of thousands of companies that have to modify their internal processes and deploy new technologies for traceability to work. As the FDA pointed out in its press release, if one participant in the middle of the chain is unable to provide quality data traceability, that particular product will be impaired.”
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The FDA intends to use the extended time period to continue the agency’s work with stakeholders, including by participating in cross-sector dialogue to identify solutions to implementation challenges and by continuing to provide technical assistance, tools and other resources to assist industry with implementation.
The final rule applies to domestic and foreign entities producing food for U.S. consumption and was issued in 2022 in accordance with the FDA Food Safety Modernization Act.
Several industry leaders also shared their support of the extension, while additionally suggesting the FDA should revisit the FSMA 204 rule itself.
“Disproportionately impacting smaller grocers, the traceability rule’s original timeline was nearly impossible to meet across the vast and dynamic food system. It quickly added exorbitant costs and operational complexity, threatening grocers’ ability to serve their communities effectively. The FDA’s decision to delay compliance provides much-needed relief for independent grocers, who would have been forced to pass these burdensome costs on to consumers,” said Stephanie Johnson, the National Grocers Association’s (NGA) group VP of government relations. “NGA remains committed to working with the FDA and federal regulators to ensure our nation’s food safety policies are fair, effective and practical for businesses of all sizes.”
FMI – The Food Industry Association President and CEO Leslie G. Sarasin said, “FMI applauds FDA’s announcement that the agency intends to extend the compliance date for the Food Traceability Rule by 30 months. While additional time is critical for efficient implementation across all sectors, we also strongly believe FDA should reexamine certain aspects of the rule to provide flexibility for the industry to improve traceability without unnecessarily burdening the supply chain and increasing food costs to consumers. Today’s extension is critical to allow the industry to meet the regulation’s intent while ensuring FDA is able to receive and utilize the data it needs to improve food safety more efficiently with the least impact on consumer prices.
“The food traceability rule is the most complex FDA regulation our industry has ever faced. Our member companies are spending millions of dollars every day to try to comply with its complexity, even as it is clear the rule is unworkable in its current form and may not achieve the agency’s stated goals. While we fully support efforts to improve traceability, we must ensure that FDA can use the information required by the regulation to improve food safety before billions of dollars and millions of hours are invested that will drive up costs throughout the supply chain.”