The U.S. Food and Drug Administration has delayed the compliance date for its Food Traceability Final Rule, fulfilling Section 204(d) of the Food Safety Modernization Act (FSMA 204), by 30 months. The compliance date was originally set for January 20, 2026.
Congress required FDA to enact a Food Traceability Final Rule as part of FSMA, which was passed with bipartisan support in 2010. FSMA directed FDA to propose recordkeeping requirements for certain “high-risk” foods no later than January 2013. When FDA failed to propose the recordkeeping requirements by the deadline, the Center for Food Safety sued the agency, leading to a federal court order mandating that it propose requirements by September 2020 and finalize the rulemaking process by November 2022—which FDA successfully achieved.
Foods subject to the final rule requirements appear on the Food Traceability List (FTL). At the core of the final rule is a requirement that individuals who manufacture, process, pack, or hold food on the FTL maintain traceability records including Key Data Elements related to Critical Tracking Events. When requested by FDA for the investigation of food safety incidents, covered firms will be required to provide information to the agency within a reasonable timeframe.
FDA’s Reasoning: Industry Isn’t Ready
FDA says it remains committed to implementation of the Food Traceability Final Rule, as it will allow for faster identification and removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. The agency also says it does not intend to amend the requirements of the final rule. Rather, the compliance date was extended 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.”
The agency’s reasoning for extending the compliance date is that “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,” FDA states that, because FSMA 204 requires coordination between different entities spanning the supply chain, “to achieve the full public health benefits of the final rule, all covered entities must be in compliance,” and therefore, all regulated sectors must be granted more time to fully implement the final rule’s requirements.
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 agency will formally extend the compliance date using appropriate procedures at a later time, including publishing a proposed rule in the Federal Register.
Consumer Protection Groups Express Disapproval
Major food industry watchdog group Consumer Reports has expressed its disapproval of FDA’s decision to delay FSMA 204 compliance, saying, “This decision is extremely disappointing and puts consumers at risk of getting sick from unsafe food because a small segment of the industry pushed for delay, despite having 15 years to prepare. Many retailers have already said that they expect their suppliers to follow the rule’s requirements in advance of the compliance date, but today’s announcement may interfere with this progress. Delaying this critical food safety rule undermines the administration’s goal of making America healthy again.”
Consumer Reports has been urging FDA to resist industry pressure to delay the Food Traceability Final Rule alongside the Consumer Federation of America’s Safe Food Coalition, the Center for Science in the Public Interest (CSPI), and other notable advocacy organizations. In response to earlier legislative efforts launched by Congress to delay FSMA 204 implementation, the Safe Food Coalition said, “When regulators cannot determine the source of a foodborne illness outbreak, more consumers get sick, and more products get recalled, causing prices to increase. FDA should stick to its timeline.” CSPI added, “Responsible members of the food industry are already working with FDA to comply with traceability requirements… that effort [would] go to waste by turning the clock back on this very sensible and necessary policy.”
For a discussion with Thomas Gremillion, J.D., M.A, the Director of Food Policy at the Consumer Federation of America, in which he shares concerns about efforts to delay or weaken FDA’s Food Traceability Final Rule and reviews industry’s ability to comply by the January 2026 deadline, listen to Episode 183 of the Food Safety Matters podcast here.
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