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Audit Finds Lapses in FDA Imported Food Recalls

Officials at the U.S. Food and Drug Administration have made some serious missteps trying to keep potentially hazardous imported food off the market, according to a new government audit.

The FDA did not always follow its own procedures to ensure foods were effectively recalled, a new report by the Health and Human Services Inspector General found. The document, released Tuesday, examined 17 import recalls from 2007 and 2008 and found multiple failures by FDA and foreign food firms.

“FDA’s guidance for developing and implementing food recalls was not adequate to ensure the safety of the Nation’s food supply because it was not enforceable,” reads the report, noting that before the FDA Food Safety Modernization Act was signed into law in January 2011, FDA did not have mandatory recall authority. “In addition, FDA did not always follow its own procedures for ensuring that the recall process operated efficiently and effectively.”

Of the 17 recalls scrutinized, 7 were for Salmonella, 5 were for Listeria monocytogenes, 4 were for potential contamination with botulinum toxin, and 1 was for unacceptable lead levels in beverage pitchers. The products involved include cantaloupe, frozen mussel meat, fish, cheese, and sesame seed.
 
The audit found that firms did not promptly initiate recalls. In two examples, there was a lag time of 28 and 102 days between when FDA became aware of contamination problems and a recall. Even more worrisome, in 13 of the 17 recalls, firms did not submit essential information about the contaminated product.
 
In response to recalls, FDA did not conduct inspections or obtain complete information on the contamination incidents in 14 of the 17 incidents. In 13 of the 17 cases, FDA did not witness the disposal of the products or obtain required documentation that the food items had been properly disposed of.
 
Democratic lawmakers pointed to the report as reason to boost resources for FDA. Sen. Tom Harkin (D-IA) said the agency needed funding to improve recall response.

”This report shows compellingly that FDA must take far stronger and faster action to protect American consumers by getting contaminated food imports off the market,” said Harkin, in a statement Tuesday. “Recalls must be started more rapidly and FDA needs to follow up more carefully to make sure the recall actually happens.”

“Congress greatly strengthened FDA’s hand to enforce food recalls in the Food Safety Modernization Act, but regrettably FDA’s ability to carry out that law and the recommendations in this OIG report will be badly impaired if FDA is starved of critical funding as the House’s agriculture appropriations legislation would do,” added Harkin, a key backer of the sweeping new food safety law, which for the first time grants FDA mandatory recall authority, and asks the agency to improve food import oversight.
 
Congresswoman Rosa DeLauro (D-CT) echoed similar concern about FDA funding, citing the latest Centers for Disease Control and Prevention Control statistics on foodborne illness in America: 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths annually.
 
DeLauro said that while the new bill is “a great first step” toward reforming the dilapidated food safety system — deemed a high risk area by the Government Accountability Office — the latest report “clearly shows that there is room for significant improvement in the FDA’s recall of unsafe food, specifically imported food.”
 
“That is why I am so concerned with the drastic budget cuts included in the House majority’s budget for FY 2012,” said DeLauro, the former chair of the House Appropriations subcommittee that oversees FDA’s budget.  The agriculture appropriations bill that passed the House last week cuts $280 million from FDA, $87 million of which will impact food safety programs at the agency.

“I believe that we need to invest in the FDA to protect the health of consumers and the safety of our food products,” said DeLauro, in a statement. “But these cuts will tie the FDA’s hands, restricting their oversight and effectiveness, and asking them to do more with less–this is about life and death. We must do better.”

The report recommends that FDA consider the results of the review as it moves to implement the FDA Food Safety Modernization Act and that the agency simply stick to following its own procedures for monitoring recalls. FDA agreed with the recommendations in the audit. 

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