FDA Not Doing Enough To Fix Serious Food Safety Violations, Report Finds

Sep 28, 2017
Originally published on September 27, 2017 7:06 pm

Every year about 130,000 people in the U.S. are hospitalized with a foodborne illness, and 3,000 people die.

To protect against this, the Food and Drug Administration inspects facilities that produce and handle food to ensure safety and compliance with regulations.

But a new report from the Department of Health and Human Services' Office of Inspector General raises some red flags about the inspections program.

"We found a number of weaknesses in the way that FDA is protecting the food supply," Meridith Seife, the deputy regional inspector general, told us.

For instance, FDA often relies on facilities to voluntarily correct violations, which can be ineffective.

Consider this case: Back in 2013, when FDA inspectors went into a facility in Kansas that produces beans and sauces, they uncovered serious problems.

"Inspectors found rainwater leaking through the roof, directly above where food was being prepared," Seife says. "And perhaps most worrisome, the inspection revealed the presence of listeria throughout the facility." Listeria is a pathogen that can cause life-threatening illness.

The FDA issued a warning letter to the facility and requested prompt correction. But the problems were not fixed. "These violations went uncorrected for the next two years," according to the report.

"It is clear that FDA could have done more in this case to have compelled the facility to act more quickly," Seife told us.

Overall, the report concludes that the FDA "consistently failed to conduct timely followup inspections to ensure that facilities corrected significant inspection violations." And in 17 percent of cases, the FDA did not conduct a follow-up inspection at all. Also, in some instances where inspectors found significant violations, the FDA took no enforcement action.

The Food Safety Modernization Act, which was signed into law in 2011, aims to ensure a prevention-oriented approach to food safety. The law gave FDA new enforcement authority so the agency could better respond to problems. But the new report concludes that the FDA has rarely taken advantage of these new tools.

"We think FDA really needs to do more to take swift and effective action" to ensure that safety problems at food facilities are fixed promptly, Seife says.

Officials at the FDA have reviewed the report. The agency's response is included as an appendix. "FDA agrees that there are challenges in its conduct of domestic inspections," writes Lisa Rovin, deputy associate commissioner for public health strategy and analysis at the FDA.

Rovin says that FDA concurs with the recommendations in the inspector general's report, including the need to ensure better use of resources and to take appropriate action against all facilities with significant violations.

In a response from the FDA on Wednesday, a spokesperson said the agency is working as effectively and rapidly as possible to implement the changes brought forth by the Food Safety Modernization Act. She says "our commitment to public health remains strong and unwavering."

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Every year in the U.S., foodborne illness leads to about 130,000 hospitalizations and is responsible for about 3,000 deaths. To help protect against this, the Food and Drug Administration inspects facilities that produce and handle food. But a new report raises some red flags about the inspections program. It comes from the Department of Health and Human Services' Office of Inspector General, and it concludes the FDA is not doing enough to fix some of the serious safety violations that it finds. NPR's Allison Aubrey reports.

ALLISON AUBREY, BYLINE: Back in 2013, FDA inspectors went into a facility in Kansas that produces beans and sauces and found some serious problems. Here's Meridith Seife of the Department of Health and Human Services' Office of Inspector General.

MERIDITH SEIFE: What inspectors found were rainwater leaking through the roof directly about where food was being prepared. There were cracks in walls that prohibited adequate cleaning. And perhaps most worrisome, the inspection revealed the presence of listeria throughout the facility.

AUBREY: Listeria is a pathogen that can cause life-threatening illness. Now, Seife says the FDA does have the power to take swift action that could compel facilities to fix problems. But in this case and many others, she says the FDA issued a warning letter asking the company to voluntarily correct its violations. The problem, Seife says, is that oftentimes this just doesn't work. In the Kansas facility, the same unsanitary conditions were documented again and again in three subsequent inspections.

SEIFE: What I found most disturbing is that in our report, we found that there were a lot of instances the facilities just weren't fixing the problem, and the FDA wasn't moving to take stronger action.

AUBREY: The inspector general's report also found that for almost half of the serious violations inspectors found, the FDA failed to conduct timely follow-up inspections within one year. And Seife says in too many cases, the FDA could have done more.

SEIFE: In fact we found that 22 percent of the time, FDA took no action when it found these serious violations.

AUBREY: Going forward, Seife says the FDA could step up the use of enforcement tools such as seizures or injunctions or detain food from facilities that have serious violations so the food never enters the marketplace.

SEIFE: We think FDA really needs to do more to take swift and effective action to make sure that when really worrisome conditions are found in our food supply, that FDA's stopping that.

AUBREY: Officials at the FDA have reviewed the inspector general's report, and they say they agree there are challenges. They also concur with all the recommendations about how to improve the outcomes. Allison Aubrey, NPR News. Transcript provided by NPR, Copyright NPR.