A report from the Government Accountability Office says the FDA has still not met requirements of the 2011 Food Safety Modernization Act.
The Act (FSMA) was written with the intent to shift the Food and Drug Administration’s focus away from reaction and toward the prevention of foodborne illnesses. The Government Accountability Office (GAO) report says the FDA has not only failed to meet the requirements of FSMA, but has also not assessed whether the framework created so far has contributed to preventing foodborne illnesses.
One key requirement that the FDA has failed to meet is to establish a system to improve its capacity to trace food, which is crucial to identify and contain foodborne illness outbreaks. Officials with the FDA told the GAO investigators that it will take until July 2028 for the agency to establish a system to trace food. That’s 17 years after the FSMA was signed into law.
In conducting its review, the GAO focused on sections of FSMA that provide a foundation for creating a modern, risk-based framework for food safety. The GAO compared FDA’s efforts with requirements in FSMA and key practices for federal performance management, which GAO developed based on federal laws, guidance, and past GAO work. The GAO also interviewed agency officials and 17 selected stakeholders, representing industry associations, consumer advocacy groups, and state and local regulators.
What the GAO found
While the FSMA was signed into law on Jan. 4, 2011, the FDA did not begin issuing required rules until 2015. Since then, the agency has issued nine rules to designed to prevent foodborne illnesses.
However, the FDA still has not met five of the requirements of the FSMA. The agency has failed to:
- issue guidance on hazard analysis and preventive controls for human food;
- issue guidance to protect against the intentional adulteration, or tampering, of food;
- report on the progress of implementing a national food emergency response laboratory network;
- publish updated good agricultural practices for fruits and vegetables; and
- establish a system to improve FDA’s capacity to track and trace food that is in the United States.
In their defense, FDA officials said “competing priorities” and a reorganization of the agency in 2024 have been responsible for the agency’s failure to meet the requirements of the 2011 FSMA.
Although the FDA has published nine rules required by the FSMA, it has not developed performance management processes to assess whether industry is meeting the requirements of those rules, according to the GAO’s report.
GAO recommendations
The GAO report identified seven actions the FDA should take to meet the requirements of the FSMA. According to the GAO, the Department of Health and Human Services — which houses the FDA — concurs with the recommendations.
The seven recommendations from the GAO are:
- The commissioner of FDA should ensure that the Human Foods Program establishes a time frame for finalizing the agency's guidance for hazard analysis and preventive controls for human food and issues the guidance as required by FSMA's section 103.
- The commissioner of FDA should ensure that the Human Foods Program establishes a time frame for finalizing the agency's guidance to protect against the intentional adulteration of food and issues the guidance as required by FSMA's section 106.
- The commissioner of FDA should ensure that the Human Foods Program publishes a report in 2025 on the progress in implementing a national food emergency response laboratory network, as required by FSMA's section 202. If FDA does not expect to publish a report in 2025, it should inform Congress and stakeholders, in a timely manner, of when it expects to publish the report.
- The Commissioner of FDA should ensure that the Human Foods Program establishes milestones and timelines for publishing future reports on the progress in implementing a national food emergency response laboratory network and publishes the reports as required by FSMA's section 202.
- The Commissioner of FDA should ensure that the Human Foods Program establishes milestones and timelines for updating the agency's good agricultural practices for fruits and vegetables and publishes them as required by FSMA's section 105.
- The Commissioner of FDA should ensure that the Human Foods Program develops a plan with milestones and timelines for establishing a product tracing system to enhance FDA's existing foodborne outbreak response processes, and establishes the system as required by FSMA's section 204.
- The Commissioner of FDA should ensure the Human Foods Program and Center for Veterinary Medicine develops and implements a performance management process to assess the results of FDA's rules and their contribution to the prevention of foodborne illness. This process should include setting goals to identify results to achieve, collecting information to measure performance, and using that information to assess results and inform decisions for each rule.
