The Government Accountability Office reveals FDA has failed to meet domestic and international food safety inspection targets mandated by the Food Safety Modernization Act since 2018 – a troubling revelation that four US senators worry will worsen as the agency plans to reduce state and local funding for food safety programs.
While the US food supply is “generally considered safe,” and “FDA conducted thousands of routine surveillance food safety inspections of domestic and foreign food facilities” between 2018 and 2023, the agency failed to routinely inspect all high-risk facilities as frequently as mandated by FSMA, according to a GAO investigation and report published last week.
“According to FDA data, in fiscal year 2019 FDA did not inspect – or attempt to inspect – about 7% of high-risk domestic food facility by their cover-by date, as required by FSMA,” GAO reports.
This failure is a high point based on inspection data for 2020 through 2023, the most recent year with complete results.
In fiscal years 2020 and 2021, the percentage of high-risk domestic facilities FDA failed to inspect – or attempt to inspect – increased dramatically to 40% and 49%, respectively. The inspection rate for non-high-risk facilities was even higher, with FDA’s failure to inspect non-high-risk facilities by their cover-by data increasing from abut 38% to nearly 74% between 2020 and 2021.
Insufficient inspectors hinders FDA’s ability to meet targets
FDA attributed the sharp drop-off to a 35-day government shutdown in fiscal year 2019 and the COVID-19 pandemic that began in 2020, which created a backlog that the agency continued to address at least through August 2024, according to GAO.
The agency’s ongoing struggles to hit inspection targets post-pandemic boil down to a stubbornly insufficient workforce despite FDA’s efforts to hire and train new inspectors.
FDA officials explained to GAO that it “has consistently hired new staff” but the hiring rate has not outpaced loss – another problem that seems unlikely to improve given nearly one-quarter of the 432 investigators working for FDA as of July 2024 were eligible for retirement and even more slated for eligibility within the year, according to the GAO report.
FDA told GAO it plans to address this “mission-critical” deficit in 2025 by aggressively recruiting inspectors and offering retention incentives to stem the exodus of current investigators. It also said the reorganization of its Human Foods Program, which officially launched in October, would partly address workforce and resources challenges.
“While these actions represent positive steps, FDA continues to face long-standing and significant workforce capacity challenges,” reports GAO. It adds FDA lacks necessary information to manage its workload and either has not effectively implemented previous GAO recommendations or has no plans to do so.
GAO calls for change
As such, GAO is calling on Congress and FDA to enhance the agency’s inspection goals and processes.
Specifically, the watchdog recommends:
- Congress direct FDA to determine how many foreign food facility inspections are necessary to ensure the safety of imported food, and based on this assessment, update FDA’s annual target for foreign food facility inspections.
- FDA should identify how it can minimize attempts to inspect domestic food facilities, which often simply confirm a facility is no longer operational, so it can more efficiently use those funds and time.
- FDA’s commissioner should develop and implement a formal performance management process focused on its food safety inspection efforts.
FDA agreed with all the recommendations, according to a statement included with the report.
Foodborne illness outbreaks abound
GAO’s critical assessment of FDA’s food safety inspection performance comes at a time when several high-profile foodborne illness outbreaks have sickened millions and killed consumers.
“Each year, foodborne illness sickens tens of millions of Americans. Of these, tens of thousands are hospitalized and thousands die,” GAO notes, citing data from the Centers for Disease Control and Prevention.
Among these in 2024 was a deadly multistate listeria outbreak traced back to inadequate sanitation at a Boar’s Head plant in Virginia that killed 10 and sickened 61 last summer, according to a USDA report released Jan. 10.
GAO also cited an October 2024 E. coli outbreak that as of Dec. 3 killed one person and sickened at least 104, and another Listeria outbreak in 2024 that killed two and resulted in the hospitalization of 23 people.
Senators scrutinize FDA ‘cuts’ and spending
In a letter sent to FDA last week, several state legislators expressed concern that FDA’s ability to identify and prevent foodborne illness outbreaks could be further hampered if the agency goes through with planned funding cuts for state and local food safety programs.
FDA Deputy Commissioner for Human Foods Jim Jones told stakeholders last April that in 2025 the agency would de facto cut by 30% the funds it gives to state partners for food safety inspections.
He explained during a webinar hosted by the Alliance for a Stronger FDA that over the past five years, FDA has redirected to states about $119 million annually for food safety initiatives, which is about $36 million more than the $83 million allocated by FDA in its yearly budgets.
The extra funding came from “excess, unspent dollars,” that Jones said would “start shrinking” if FDA’s budget did not increase. He explained that without an increase in the budget, the excess funding available in prior years would “start to fall” in fiscal 2025.
At the time, he stressed FDA’s budget for state funding “has been consistent,” but he acknowledged it would not feel that way for states that relied on the extra money.
“We are talking with our state colleagues to figure out a strategy for how to manage this going forward, because they will face a very real reduction, whether it was in our budget or not, they were actually getting a larger amount. It is a difficult issue that we need to collectively get our arms around and figure out how to manage,” he said in the webinar.
According to the letter to FDA from Sens. Richard Blumenthal, Tina Smith, Cory Booker and Richard Durbin, FDA also plans to reallocate about 65% or $10 million of funding meant for the Office of Inspection and Investigation (OII), which supports training investigators and inspectors at the federal, state and local levels.
Senators seek additional budget information
In light of these “concerning” cuts, the senators ask FDA where the funds were reallocated to and why, as well as which state-led food safety inspections will no longer be funded and how OII staff will handle them.
In addition, the senators ask FDA:
- How the new Human Foods Program, which includes OII, will reduce bureaucracy and improve efficiency,
- To clarify staffing and related expenses for domestic and foreign inspectors and supervisory staff, and
- If the agency has “cross referenced the functions and responsibilities” of the HFP and OII to identify redundancies and programs that are no longer necessary or have minimal public health impact.
The senators ask FDA to respond by Feb. 16.
