FDA Only Conducted Half of Food Safety Audits
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According to new documents sent to Congress, the Food and Drug Administration only conducted about half of the state food safety audits it promised to do in the two years before the recent peanut salmonella outbreak. The documents show that the agency did not do any of the required audits of the state-run food inspections in five states during 2007-2008. In addition the FDA was unable to say whether audits were conducted at all in an additional 11 states. Georgia and Texas, which were linked to the wide-ranging peanut recall earlier this year, were included in that 11. Only 14 states received 100% of the audits promised.
FDA audits are to ensure that food is inspected properly by states that contract with the FDA to perform safety checks. The FDA has admitted that the food safety program is a turnaround project.
Stephen R. Mason, acting assistant commissioner for legislation at the FDA, said the recent salmonella outbreak “has highlighted limitations in our current approach and has prompted internal discussions on potential enhancements to the audit program.”
In 2000 the Health and Human Services Department, which oversees the FDA, said that the agency needed to place a high priority on better evaluating the effectiveness of state inspections of food production facilities. In response to those recommendations, the FDA set a standard that 7% of all state inspections should be audited by the federal agency. The FDA acknowledges that it has fallen far short of that goal.
In 2006-2007 audits were not done at all in Arkansas, Maryland, South Carolina, Tennessee, Texas, Virginia, West Virginia, and Wyoming, and in 2007-2008 audits were not done in California, Iowa, Kansas, Nebraska, and Wyoming. Only 9% of the promised audits were done in California during 2006-2007, in which time an E. coli outbreak in spinach caused three deaths and more than 200 illnesses.
FDA spokeswoman Susan Cruzan said “Although FDA has not been able to fulfill the goal of conducting 100% of the audits expected under FDA’s internal auditing policy, FDA has audited each state at least once, has good knowledge of the state programs and state inspection personnel, and works to improve the programs as needed.”
Congress has since vowed to step up oversight of the FDA. Several members have introduced bills to overhaul the agency, such as proposals to separate its food safety and drug oversight duties, as well as to significantly increase funding.