The Food and Drug Administration has not met its mandated targets for domestic and international food safety inspections since 2018, according to a Government Accountability Office report released today.
Under the Food Safety Modernization Act, FDA is expected to inspect each high-risk domestic food facility at least every three years. Inspectors are also expected to visit each non-high-risk facility at least once every five years. However, GAO's examination of FDA data found the agency did not successfully meet this target. The inspection shortfall increased during the pandemic.
The Centers for Disease Control and Prevention estimates that each year, "roughly one in six Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases."
The most prominent recent case was an E. coli outbreak linked to slivered onions served on McDonald's Quarter Pounders. One person died and 104 were sickened, according to CDC.
The GAO’s analysis includes domestic inspections conducted by federal investigators and states acting on behalf of the agency, said Steve Morris, director with GAO’s Natural Resources and Environment team and lead on the report. It does not address inspections and oversight of restaurants, grocery stores, cafeterias and other facilities that handle food and are under the jurisdiction of state food safety programs.
In fiscal 2019, FDA did not inspect about 7% of high-risk domestic facilities by its deadline. That mark increased to 40% and 49% in 2020 and 2021, respectively, which created a backlog for subsequent years.
The agency also failed to conduct required inspections at non-high-risk facilities during the same time period. During fiscal years 2020 and 2021, the percentage of these facilities that FDA did not inspect rose from about 38% to nearly 74%.
Agency officials attributed the increases to the 35-day government shutdown in fiscal year 2019 and the COVID-19 pandemic that began in 2020. Officials also told GAO that as of August 2024, FDA was continuing to address the backlog of inspections created during the pandemic.
There is an even greater gap between mandated and completed foreign facility inspections, according to the report. FDA’s annual target for these inspections is 19,200. However, between 2018 and 2023, the agency only completed an average of 917 foreign food safety inspections each year.
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FDA officials told GAO that the 19,200-facility target is not realistic given existing workforce and resources. They also said the pandemic had an effect on these inspections, as well.
The GAO report also identified significant challenges in recruiting, hiring and retaining investigators. In July 2024, FDA had 432 investigators, which is 90% of the full-time equivalent ceiling. FDA officials also said that the need to use agency resources for emergencies like foodborne illness outbreaks affects the agency’s ability to conduct routine inspections.
GAO recommended FDA find ways to minimize incidences of attempted domestic inspections, which made up about one-third of inspections FDA counted toward its mandate from 2018 to 2023. "Attempted inspections" are when FDA investigators try to inspect a food facility, but cannot, because, for example, the facility may not be operating on the day of inspection or it may have gone out of business.
Additionally, GAO suggested FDA implement a formal performance management process and determine a new sufficient annual number of foreign inspections to maintain safety.
The data GAO used, called the FSMA Tracker, includes both FDA and state-contracted inspections, according to the site.
FDA has oversight over about 80% of the food supply, including domestic and imported seafood, fruits, vegetables, grains and more. USDA’s Food Safety and Inspection Service is responsible for inspecting most domestic and imported meat and poultry.
Through FSMA, FDA is allowed to contract with states to complete inspections. States now complete the bulk of inspections, including 50% at food processing facilities, 90% for produce safety and 100% at retail establishments.
In recent years, FDA has allocated about $34 million to states and local food safety programs to complete this work.
However, agency officials have been warning states that FDA likely won’t have those carryfunds moving forward, and programs should brace for a cut.
State officials have warned that without those funds, states could elect to not continue in their contract with FDA. This could increase the FDA’s workload, and require federal inspectors to complete these, often at a higher cost.
Last month, senators sent a letter to Jim Jones, FDA’s deputy commissioner for the Human Foods Program, pressing for an explanation of proposed cuts.
“While we appreciate that you may need to occasionally reallocate resources based on programmatic needs, we are concerned that the full impact of the proposed cuts to state and local programs has not been taken into account and that the agency has failed to fully consider alternative options,” senators wrote in the letter.
Both the House and Senate included report language in the fiscal year 2025 draft appropriation bills directing FDA to maintain funding for state and local programs. Senators wrote that should FDA refuse this, they are concerned it could undo “years of progress toward establishing a truly integrated food safety system.”
The letter includes a set of questions for Jones and the Human Foods Program and seeks a reply by Feb. 16. It was signed by Democratic Sens. Richard Blumenthal of Connecticut, Tina Smith of Minnesota, Cory Booker of New Jersey and Dick Durbin of Illinois.
An FDA spokesperson said the agency had received the letter and will respond directly to Sens. Blumenthal, Smith, Booker and Durbin.
State legislatures and agriculture departments are already taking action ahead of the anticipated cuts, said Becky Garrison, director of public policy at the National Association of State Departments of Agriculture.NASDA anticipates 300 to 400 jobs will be lost at state programs due to the funding decrease. This equates to a loss of over $60 million invested in training those employees.The group also expects a decrease in the number of Rapid Response Teams, which are critical in foodborne illness outbreaks and product recalls, said Garrison. There are currently 26 of those.NASDA is pushing Congress to recognize the urgency of the situation and the potential consequences to the food and agriculture industry. Specifically, the group is urging appropriators to include additional funding in upcoming funding bills.Given the additional costs associated with federal inspectors taking on more of the states’ workload, and the potential impact to public health, Garrison said it’s wise for Congress to invest in these state programs now.“We sincerely do need this investment in our domestic food systems and the safety of our agriculture food systems here in the U.S.,” Garrison said. “We will see this exasperate federal budget if we don't keep funding and attention on filling these shortfalls on the front side of this and invest in the infrastructure we at least currently have.”
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