FDA needs additional state help to do its job

Let’s be honest. The Food and Drug Administration is a huge dumpster fire when it comes to complying with federal food inspection laws.

In January of this year, the U.S Government Accountability Office reported that FDA has not met its domestic and foreign inspection targets since fiscal year 2018. That’s six years and counting.

Some years the inspection numbers are gosh awful. For instance, in fiscal year 2021 FDA failed to inspect about 49% of high-risk domestic facilities by the legally required date. That was a huge improvement over fiscal year 2019 when the rate was just 7%. And no, that is not a typo.

The FDA Food Safety Modernization Act requires FDA to inspect every high-risk domestic food facility at least once every three years and each non high-risk facility at least once every five years.

So the FDA isn’t doing such a swell job of protecting us from food contamination.

Why? The GAO reports significant workforce issues:

“FDA officials acknowledged that the agency was not capable of meeting its domestic or foreign inspection targets given its existing workforce capacity and resources. FDA has taken steps to identify the staff and resources it needs to meet its domestic inspection targets, but has not done so for its foreign inspection efforts. Specifically, as of July 2024, FDA’s foreign cadre — the group of investigators dedicated to conducting foreign inspections — totaled 20 individuals… FDA officials were not able to tell us whether 20 investigators is an appropriate size for its foreign cadre, or whether the current workload ratio between the foreign and domestic cadres is optimal for conducting the highest possible number of annual foreign inspections.”

Bottom line: FDA doesn’t have enough inspectors to meet its legally required inspection targets. My guess is it’s a problem of both hiring and retention. And it may get worse real soon. As of July 2024, nearly 25% of FDA inspectors were eligible to retire. It takes two years to train a new investigator.

And it may get worse real soon. As of July 2024, nearly 25% of FDA inspectors were eligible to retire. It takes two years to train a new investigator.

FDA should be holding weekly job fairs in every state of the nation. And Congress should be making food safety a front line issue.

Yet none of that is happening. What is happening is increasingly state governments are doing FDA’s legally mandated food inspections. The GAO reports FDA has had contracts with 43 states and Puerto Rico to do about a third of routine inspections in recent fiscal years.

Now the White House is proposing to shift all routine food inspections to state oversight.

Overall, states have done an admirable job of backstopping the FDA. Currently, states are inspecting about 90% of produce facilities and half of all manufactured food facility inspections. A majority of the inspections are conducted by state agricultural departments.

Steve Mandernach, executive director of the nonprofit advocacy group Association of Food and Drug Officials, says “FDA audits have determined state inspections to be high quality, and the costs show them to be a good economic value.”

So the White House plan has potential. There are huge ifs.

I wouldn’t even be writing this column if Congress had provided adequate funding and oversight for FDA inspections in the first place.

Successful implementation demands adequate funding — specifically, whether federal state contracts will include enough additional dollars to offset increased state costs.

But there are other considerations, including to what degree do states have the necessary infrastructure to do inspections alone? Will the FDA have the necessary dollars for program oversight and, if necessary, to conduct re-inspections?

The White House, whether it intended to or not, has given Congress an opportunity to fix the United States’ food safety issues. States would focus on all routine inspections, freeing FDA to give particular attention to foreign food inspections and high risk domestic inspections such as infant baby formula. Win win. The devil is in the details.

History shows that Congress hasn’t done enough to protect the public from food borne illnesses.

Lawmakers, please do the right thing for the public good.