GAO: FDA Still Needs to Establish Timelines to Fulfill FSMA Obligations
As the FDA seeks to fully implement its 2022 food traceability regulations by July 2028, the agency still needs to establish timelines for some of its ether Food Safety Modernization Act regulatory requirements to ensure the agency meets its deadlines, according to a Government Accountability Office report released this week. Activities that the FDA still needs to pursue include issuing guidance to protect against the intentional adulteration of food and establishing a system to improve the FDA's capacity to track and trace food that is in the U.S.
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The food traceability regulations fall under the FDA's Food Safety Modernization Act (FSMA), enacted in 2011. The agency had Jan. 20, 2026 as its enforcement date for its 2022 food traceability regulations, but it said in March 2025 that it would delay that enforcement date by 30 months (see 2503200060).
According to the GAO report, the FDA was to establish a product tracing system to receive information that improves the capacity to effectively and rapidly track and trace food that is in the U.S. or offered for import. The FDA said it began developing that system in 2024 and that it would be ready by the 2028 deadline, according to the report.
As the FDA seeks to meet its deadline, the GAO report recommended that the FDA set goals to identify what results it is seeking to achieve. For instance, in 2015, when the FDA finalized its Foreign Supplier Verification Program rule to ensure the safety of imported food, the agency developed a long-term outcome for that rule, which was to reduce the risk of illness or injury attributed to imported foods, GAO said.
The FDA should implement timelines and establish milestones to ensure it meets the regulations' goals, according to the report. The FDA also should establish a performance management process, so the results of each initiative can be measured, the report continued.
"Establishing time frames for completing the FSMA requirements ... could better ensure success as FDA continues to implement FSMA’s preventive framework," the GAO report said. "For those requirements for which FDA is in the early stages of completing or has not yet begun, establishing both milestones and timelines for doing so would also better position FDA to track its progress, identify potential risks, and make adjustments as needed. Completing the requirements would help address stakeholder concerns that industry and others may not have the information they need to effectively implement the rules and FSMA’s preventive framework."
The report continued: "If FDA is unable to complete certain requirements as planned, such as publishing a report on the progress in implementing a national food emergency response laboratory network in 2025, informing Congress and stakeholders of when it expects to do so would ... provide additional accountability and support congressional oversight."
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