A Government Accountability Office report found that the FDA still has not met the requirements of the 2011 Food Safety Modernization Act.
The law (FSMA) was written to shift the Food and Drug Administration's focus from responding to preventing foodborne illnesses. The Government Accountability Office (GAO) report found that the FDA not only failed to implement FSMA requirements, but also failed to evaluate whether the framework put in place to date contributed to the prevention of foodborne illness.
One of the key requirements that the FDA has failed to meet is the creation of a system to improve food traceability capabilities, which is critical to detecting and containing outbreaks of foodborne illnesses. FDA officials told GAO investigators that the agency would have until July 2028 to create a food traceability system. This is 17 years after FSMA was signed into law.
In conducting its review, GAO focused on sections of FSMA that provide the foundation for establishing a modern, risk-based food safety system. GAO compared FDA's efforts to FSMA requirements and key federal performance management practices that GAO developed based on federal laws, guidance, and GAO's past work. GAO also interviewed agency officials and 17 selected stakeholders representing industry associations, consumer advocacy groups, and state and local regulators.
What the GAO found
Although FSMA was signed into law on January 4, 2011, the FDA did not begin issuing the required regulations until 2015. Since then, the agency has issued nine regulations aimed at preventing foodborne illnesses.
However, the FDA has yet to comply with five FSMA requirements. The agency failed to:
- issue guidance on hazard analysis and preventive food control;
- issue guidance on protecting against intentional adulteration or adulteration of food products;
- progress report on establishing a national network of food emergency response laboratories;
- publish updated best agricultural practices for fruits and vegetables; And
- create a system to improve the FDA's ability to track food products in the United States.
In its defense, FDA officials said that “competing priorities” and the agency's 2024 reorganization contributed to the agency's failure to comply with the 2011 FSMA.
According to the GAO report, although the FDA has published the nine rules required by FSMA, it has not developed performance management processes to assess whether the industry is meeting the requirements of those rules.
GAO Recommendations
The GAO report identified seven actions that FDA must take to comply with FSMA requirements. The Department of Health and Human Services, which houses the FDA, agrees with the recommendations, according to the GAO.
GAO's seven recommendations:
- The FDA Commissioner must ensure that the Human Food Program establishes timelines for completing the development of the agency's guidance on hazard analysis and preventative controls for human foods and issues guidance consistent with the requirements of section 103 of FSMA.
- The FDA Commissioner must ensure that the Human Food Program establishes a timeline for completing the development of agency guidance to protect against intentional food adulteration and issues guidance consistent with the requirements of section 106 of FSMA.
- The FDA Commissioner must ensure that the Human Food Program publishes a report in 2025 on progress in establishing a national network of food emergency response laboratories, as required by section 202 of FSMA. If the FDA does not plan to publish the report in 2025, it should inform Congress and stakeholders in a timely manner about when it plans to publish the report.
- The FDA Commissioner must ensure that the Human Food Program establishes milestones and deadlines for publishing future reports on progress in establishing a national network of food emergency response laboratories, and publishes reports consistent with the requirements of section 202 of FSMA.
- The FDA Commissioner must ensure that the Human Food Program establishes milestones and timelines for updating the agency's best agricultural practices for fruits and vegetables and publishes them in accordance with the requirements of section 105 of FSMA.
- The FDA Commissioner must ensure that the Human Food Program develops a plan with milestones and timelines for establishing a food traceability system to improve FDA's existing processes for responding to foodborne outbreaks, and establishes a system consistent with the requirements of section 204 of FSMA.
- The FDA Commissioner must ensure that the Human Food Program and the Center for Veterinary Medicine develop and implement a performance management process to evaluate the impact of FDA regulations and their contribution to the prevention of foodborne illness. This process should include setting goals to determine the results to be achieved, collecting information to measure performance, and using this information to evaluate results and justify decisions for each rule.
