FDA faulted over state inspections

December 14, 2011

The Food and Drug Administration is relying more often on states to inspect food plants but is failing to properly monitor those state inspections or follow through on their findings, the Department of Health and Human Services watchdog has concluded.

In a report released Wednesday, the department’s inspector general found that a lack of resources is forcing the FDA to lean more heavily on its counterparts at the state level to inspect plants responsible for everything from packing to processing foods.

More than half the agency’s inspections were done by state officials in fiscal 2009, up from 42 percent four years earlier, according to the report. If these inspections are not done properly, they can expose consumers to sometimes life-threatening illnesses.

A deadly salmonella outbreak linked to a Georgia peanut processing plant in 2009 occurred after the plant had been inspected several times by state officials working on the FDA’s behalf. The incident prompted Rep. Rosa DeLauro (D-Conn.) to ask Inspector General Daniel Levinson to examine the FDA’s oversight of its state partners.

Wednesday’s report confirms several weaknesses in that relationship, almost all of which the FDA acknowledged were indeed problems. “The report documents glitches we’re aware of. . . . These are things we are working on,” said Mike Taylor, the FDA’s deputy commissioner for foods.

The report found that the FDA has failed to ensure that the states have completed the number of inspections assigned to them. Of the 41 states the FDA was working with in 2009, eight did not complete 10 percent of the 2,170 inspections they were responsible for that year. The agency paid for 130 of the inspections that were not done.

The report did not specify how much was paid in those instances. But it did state that the FDA spent more than $8 million for state contract inspections in fiscal 2009.

The FDA also did not do its part in monitoring the inspections as required by law, according to the report.

Each year, the FDA has to audit at least 7 percent of a state’s inspections. That means that an FDA official must tag along to observe a state inspector’s performance and identify any systemic issues — such as problems that consistently emerge in multiple audits. But the agency failed to complete the required audits in 14 states, and therefore can’t determine the effectiveness of those state inspections, the report said.

“FDA officials generally attributed their inability to complete the required number of audits to a lack of resources,” the report said. An official in one of the FDA’s 14 districts said his district ran out of travel funds. Another said his district lacked trained auditors.

Even in cases where recurring problems were identified, the problems were not always addressed. Corrective action was taken in only four of the 10 states where systemic problems were found, the report said.

When audits were conducted, the most common problem cited had to do with the state inspectors’ inability to identify violations. At least 32 percent of the 419 inspectors audited had at least one deficiency. The report cited instances in which inspectors failed to note evidence of rodents or a leaky roof above exposed food.

Even when inspectors noted food safety violations, FDA officials who reviewed the inspectors’ reports did not properfly classify all of them, the report said. Officials responsible for 11 states said they did not classify some incidents as serious and in need of official action because they thought they were not allowed to, the report said.

Officials in another 11 states said that FDA was not always notified when actions were taken and therefore could not determine if the violations were properly addressed.

“Taken together, these findings demonstrate that more needs to be done to protect public health and to ensure that contract inspections are effective,” the report concluded.

Aside from the resource issues, FDA officials told investigators that the agency relies heavily on the states in part because states have more enforcement power than the federal government. For instance, state officials can sometimes instantly shut down a plant or seize unsafe food, whereas FDA cannot achieve the same instant results.

DeLauro, the congresswoman who requested the report, said that it “illustrates a vicious cycle of woefully inadequate oversight. It is clear to me that more must be done to ensure that federal inspection and oversight of food facilities best protects the public health.”

The Food Safety Modernization Act, adopted by the previous Congress, would grant the FDA more authority. But it would also demand that the agency take on more inspections and work more with the states to keep the food supply safe.

Dina ElBoghdady covers housing policy for The Washington Post.
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