Food Safety Modernization Act Implementation: Why GAO Says FDA Must Finish the Job
The FDA Food Safety Modernization Act (FSMA) was enacted to pivot the United States from a reactive posture—responding after outbreaks occur—to a preventive model designed to reduce the incidence of foodborne illness. GAO’s January 2026 assessment situates this shift in the practical reality that FDA oversees roughly 80 percent of the U.S. food supply, spanning produce, processed foods, dairy, and most seafood, and that outbreaks and contamination events continue to impose significant public health consequences. Against this backdrop, GAO evaluates whether FDA has completed the legal architecture FSMA envisioned and, critically, whether FDA has positioned itself to measure whether that architecture is achieving its intended results.
GAO finds that FDA has largely completed the “build” phase of FSMA implementation. Since 2015, FDA issued nine foundational rules that establish risk-based standards across key points in the supply chain and clarify the actions industry must take to prevent contamination. These rules collectively operationalize core FSMA concepts—hazard analysis and preventive controls, produce safety standards, sanitary transportation, intentional adulteration mitigation, laboratory accreditation, and enhanced traceability and importer verification—creating a unified preventive framework rather than a patchwork of post-incident responses.
At the same time, GAO concludes that FDA has not fully completed several statutory requirements that are integral to making the framework usable and durable in practice. GAO determined FDA has fully completed 41 of 46 key FSMA requirements it reviewed, leaving five requirements either partially complete or not complete at all. Among the unfinished work are items that directly affect implementation clarity and system capability, including completing guidance related to preventive controls and intentional adulteration, and ensuring sustained reporting and modernization efforts that would help regulated entities and partner regulators apply FSMA consistently. A particularly consequential gap concerns FDA’s capacity to track and trace food: GAO highlights the need for a product tracing system that can receive information and improve FDA’s ability to rapidly follow food through commerce—work FDA has underway but that is tied to an extended timeline.
GAO’s most pointed critique, however, is not about rule issuance; it is about results. FDA’s assessment efforts have largely emphasized monitoring compliance for a subset of rules—such as whether facilities maintain required written food safety plans—and related implementation indicators, rather than a systematic approach to determining whether the rules are reducing illness. GAO underscores that a structured performance management process—setting goals, collecting performance information, and using that information to assess results and inform decisions—would better position FDA to determine how well FSMA’s rules are working and where corrective action is needed.
Accordingly, GAO recommends that FDA establish time frames, milestones, and timelines to complete outstanding statutory requirements and, in parallel, develop and implement a performance management process covering each FSMA rule so the agency can credibly assess contribution to foodborne illness prevention. For industry participants—including federal contractors operating food production, distribution, or food-service systems—the report’s practical signal is that regulatory expectations are largely defined, but implementation guidance, traceability infrastructure, and outcome-oriented oversight may intensify as FDA closes remaining gaps and shifts from implementation to demonstrable impact.
Disclaimer: This blog post is a general summary of a GAO report and is provided for informational purposes only. It does not constitute legal, regulatory, or professional advice, and readers should consult qualified counsel or appropriate regulatory guidance for advice on specific facts or compliance obligations.