The U.S. Food and Drug Administration’s increasing reliance on state and local officials to conduct boots-on-the-ground inspections of food facilities may leave consumers vulnerable, a Health and Human Services Inspector General report states.
The report, issued Tuesday, identifies “significant weaknesses” in FDA’s oversight of these inspections, which are often conducted under contract with the agency. In 2009, FDA held contracts with 41 states to conduct FDA inspections. According to the IG report, in eight states, FDA failed to ensure that the required number of inspections was completed and even paid for inspections that were incomplete. The audit found that 10 percent of inspections were not completed and FDA paid for 130 out of the 221 incomplete inspections.
In addition to waste, the report flagged problems with following up when violations were found in food facilities. The audit found that in 11 of the 41 states with contracts, FDA officials reported they did not officially classify inspections that revealed serious violations, which would impair the agency’s ability to comprehensively assess risks. Officials overseeing another 11 states reported that when states were responsible for correcting violations, FDA was not always notified of corrective actions and was therefore “unable to ensure that serious violations had been adequately addressed.”
Perhaps unsurprisingly, IG reported that FDA had not completed the required number of audits of state contracts. The audits it did conduct, in 10 states, “revealed systemic problems that needed to be corrected” but the agency took correction action only in 4 of 10 states.
The findings are especially relevant because FDA has increasingly outsourced this work to states. The number of food facilities inspected by FDA decreased between fiscal year 2004 and 2009, but the number of facilities inspected by states under contract to FDA increased significantly, according to the report. “In fiscal year (FY) 2009, 59 percent of FDA’s food inspections were conducted by State inspectors, compared to only 42 percent in FY 2004.”
“Taken together, the findings demonstrate that more needs to be done to protect public health and to ensure that contract inspections are effective and prevent outbreaks of foodborne illness,” said the report.
The report recommends that FDA:
– Ensure that all contract inspections are completed, properly documented, and appropriately paid for.
– Ensure that contract inspections are properly classified in accordance with FDA guidance.
– Ensure that all inspection violations are remedied by routinely tracking all actions taken to correct violations.
– Ensure that the minimum audit rate is met in all states.
– Address any systemic problems identified by audits.
Rep. Rosa L. DeLauro (D-CT), Ranking Member on the Labor, Health, and Human Services Appropriations Subcommittee, requested the report be conducted after the 2009 recall of peanut butter, contaminated with Salmonella, that sickened hundreds and killed nine in 43 states.
“This new report confirms that the FDA’s increasing reliance on state contracts for inspections is compromising our food safety system and thus the health of American consumers,” said DeLauro in response to the report. “Our food safety system is of paramount concern, and yet this report 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. If the FDA intends to continue relying on contracted inspections to meet its public health responsibilities, it must ensure that those inspections are consistent and better integrated into the agency’s regulatory capacity.”
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