In January 2026, the U.S. Government Accountability Office (GAO) released a report to Congress evaluating how the U.S. Food and Drug Administration (FDA) is implementing the preventive framework under the Food Safety Modernization Act (FSMA) — the landmark law intended to shift the U.S. food safety system from reacting to foodborne illness to preventing it.
Recent media coverage has largely emphasized what the GAO report identifies as gaps and delays in FSMA implementation. While those findings point to real and ongoing challenges, they also reflect a broader reality facing the fresh produce industry: meaningful progress under FSMA requires more than issuing rules or increasing inspections. Continued effort is needed to move from enforcement-driven approaches toward regulatory models grounded in prevention, compliance support, education and continuous improvement. Achieving that shift will depend on sustained public-private collaboration and practical, on-the-ground engagement with growers, shippers and other stakeholders.
Key GAO Report Findings
Progress on Rules, but Not Complete:
Since FSMA’s enactment in 2011, FDA has issued nine foundational rules to prevent foodborne illness. These rules set standards industry must follow from produce safety to sanitary transportation. While these rules provide an essential prevention-focused framework, GAO noted that issuing regulations alone does not ensure consistent implementation or measurable public health outcomes, underscoring the need for continued compliance support, education and ongoing improvement.
Most, But Not All, Requirements Completed:
Out of 46 key statutory requirements GAO identified in FSMA, FDA has fully completed 41. However, five requirements remain unfinished, including critical guidance on hazard analysis and intentional adulteration, updated produce practices and systems for food tracking and traceability. FDA has cited competing priorities and a recent reorganization for the delay.
Limited Assessment of Outcomes:
While FDA has evaluated compliance for certain FSMA rules, GAO found that the agency has not yet implemented a comprehensive performance management framework to assess whether FSMA’s preventive controls are actually reducing foodborne illness. GAO noted that without outcome-focused metrics, it is difficult to fully assess FSMA’s public health impact.
Need for Better Performance Management:
GAO concluded that FDA lacks a consistent, agency-wide approach to setting goals, collecting data and evaluating results across all FSMA rules—an approach that would help better demonstrate the effectiveness of prevention-focused food safety efforts.
GAO Report Recommendations:
To strengthen implementation and oversight, GAO recommends that FDA complete the remaining FSMA statutory requirements—such as issuing missing guidance and establishing tracking systems—and develop and implement a robust performance management framework to more fully evaluate whether FSMA’s preventive rules are achieving their intended outcomes.
Conclusion:
The enactment of FSMA represented a significant shift in U.S. food safety oversight by establishing, for the first time, science-based federal standards and routine regulatory oversight for produce growing, harvesting, packing and holding activities, areas that historically were not subject to specific FDA food safety requirements. While current metrics regarding FSMA’s impact on reducing foodborne illness are not available, FSMA has undeniably elevated food safety awareness and expectations at the producer level and across harvesting and fresh produce handling operations. Continued public-private collaboration remains essential to building on this foundation, and Western Growers will continue working with the FDA and other stakeholders to identify challenges, share lessons learned and advance practical, science-based solutions that strengthen preventive food safety and support long-term compliance. If you have any questions on this topic, reach out to Sonia Salas at [email protected].