A report published by the U.S. Government Accountability Office (GAO) on January 7 assessed the U.S. Food and Drug Administration’s (FDA’s) ongoing implementation of the Food Safety Modernization Act (FSMA) and identified several areas requiring more work.

FSMA was enacted in 2011 to improve FDA’s approach to preventing foodborne illness. In the 15 years since FSMA’s passage, the agency has issued nine FSMA regulations that build a preventive foodborne illness framework, and completed most but not all requirements of FSMA, according to GAO.

The nine rules identified by GAO are:

• Preventive Controls for Human Food, updating FDA’s Good Manufacturing Practices (GMP) requirements and adding requirements for hazards analysis and risk-based preventive controls
• Preventive Controls for Animal Food, establishing GMP, hazards analysis, and risk-based preventive control requirements for animal food
• The Produce Safety Rule, establishing minimum standards for businesses that grow, harvest, pack, or hold certain fruits and vegetables, including agricultural water standards
• The Sanitary Transportation Rule, requiring sanitary transportation practices for those engaged in transporting food
• The Intentional Adulteration Rule, requiring facilities to address hazards that may be introduced intentionally to cause harm to public health
• Laboratory Accreditation for Analyses of Foods (LAAF), establishing a program to recognize bodies that will accredit laboratories to test food in certain circumstances
• The Food Traceability Rule (FSMA 204), establishing recordkeeping requirements for establishments that manufacture, process, pack, or hold foods included on FDA’s Food Traceability List
• The Foreign Supplier Verification Programs for Food Importers (FSVP), requiring importers to verify that the food they import for humans and animals meets U.S. safety standards
• Accreditation of Third-Party Auditors, establishing a voluntary program for the accreditation of third-party certification bodies to conduct food safety audits of foreign entities and issue certifications.

GAO also identified 46 key FSMA requirements, of which FDA has fulfilled 41. While FDA has, for example, issued several implementation guidances for industry and conducted various studies required by FSMA, the agency has not:

• Issued final guidance on hazards analysis and preventive controls for human food, separate from animal food
• Finalized guidance to protect against the intentional adulteration, or tampering, of food
• Continued to report on the progress of implementing a national Food Emergency Response Laboratory Network (FERN), failing to do so in 2021 or 2023
• Published updated Good Agricultural Practices (GAPs) for fruits and vegetables in alignment with the Produce Safety Rule
• Implemented a system to improve FDA’s capacity to track and trace food that is in the U.S. (FSMA 204)

Reasons for FDA's Incomplete Work

Reasons FDA provided to GAO as to why these areas have not yet been completed include a focus on the creation of the Human Foods Program, which finished in October 2024. 

The agency also reminded GAO of the July 2028 industry compliance date for FSMA 204/the Food Traceability Rule; originally, the FSMA 204 compliance date was set for January 2026, but it was pushed back by the current Trump Administration.

Additionally, FDA told GAO it has not yet begun work on or established a timeframe for updating GAPs for fruits and vegetables under the Produce Safety Rule.

Federal Workforce Cuts Ended FDA’s Plans to Assess FSMA Performance

GAO also noted in its report that FDA has missed opportunities to assess the results of the nine FSMA regulations and their contribution to preventing foodborne illness. Although the agency has tracked and monitored industry compliance with three rules—Preventive Controls for Human and Animal food and FSVP—these efforts do not focus on the performance of these programs. Moreover, the other six rules have been neglected in terms of assessment. FDA told GAO that work initiated in the past to measure the results of FSMA rules proved challenging to complete due to competing priorities.

Notably, FDA also noted that the October 2024 reorganization of the Human Foods Program included a plan to develop a FSMA performance management framework, which would have been the responsibility of the newly created Office of Strategic Programs—but sweeping reductions in force (RIFs) by the Trump Administration in 2025 across the federal government, including the U.S. Department of Health and Human Services (HHS) and FDA—resulted in the loss of key office staff. The Office of Strategic Programs no longer exists.

Although FDA hopes to progress this work with different resources in the future, it does not have a timeline.

GAO Recommendations 

GAO made several recommendations to complete FSMA requirements, with which HHS concurred:

• Establish a timeline for finalizing the guidance on hazards analysis and preventive controls for human food and issue the guidance
• Establish a timeline for finalizing the guidance to protect against the intentional adulteration of food and issue the guidance
• Publish a report in 2025 on the progress of implementing a FERN laboratory network and establish milestones and timelines for publishing future reports
• Establish milestones and timelines for updating the GAPs for fruits and vegetables as required by the Produce Safety Rule
• Establish an implementation plan for FSMA 204
• Develop and implement a performance management process to assess the results of FSMA regulations and their contribution to the prevention of foodborne illness.