A Government Accountability Office (GAO) report released yesterday finds that while the US Food and Drug Administration (FDA) has made strides in carrying out the 2011 Food Safety Modernization Act (FSMA), gaps remain in implementing the rules and in establishing the systems needed to measure whether the FDA’s efforts are working.
Tens of millions of Americans get foodborne illnesses each year, and thousands die from them. The FDA oversees nearly 80% of the US food supply, including fruits and vegetables, and Congress enacted FSMA to help shift the FDA’s focus from foodborne-illness response to prevention.
Some requirements still unfinished
Since 2015, the FDA has issued nine rules for preventing foodborne illnesses at key points in the food chain. These regulations set standards for growers, harvesters, and packers to help prevent contamination. In addition, the FDA has completed 41 of 46 FSMA tasks, such as issuing compliance guidelines and conducting required studies.
At the same time, the agency has not completed several crucial components identified in FSMA, such as issuing guidance on hazard analysis and reporting on the progress of a national food emergency response laboratory network.
The FDA prioritized implementing the FSMA rules over evaluating whether its regulations are helping prevent outbreaks. The GAO report emphasizes the need to track outcomes so the agency can see what’s working and what isn’t.
“Developing a performance management process would better position FDA to assess the results of the rules, with the ultimate goal of helping prevent foodborne illness,” notes the report. “Key practices for federal performance management emphasize the need for agencies to define what they are trying to achieve, collect relevant information, and use that information to assess how well they are performing and identify how they could improve.”
7 recommendations to improve foodborne-illness prevention
In response, GAO made seven recommendations to the FDA to support the prevention of foodborne illness.
Those recommendations include establishing timelines for setting adulteration guidelines, establishing milestones and timelines for food safety reports, reporting on the progress of implementing a national food emergency response laboratory network, updating recommended agricultural practices for fruit and vegetables, developing a plan for product tracing to enhance outbreak response processes, and implementing a performance-management process to assess the results of FDA’s efforts.
“The Department of Health and Human Services [HHS] concurred with the recommendations,” the GAO said. The FDA is an agency within HHS.
