FDA falls behind in auditing state food inspections

? The Food and Drug Administration conducted only about half the state food safety audits it promised in the two years before the recent peanut salmonella outbreak, according to new documents the agency sent to Congress.

The documents show the agency did not do any of the required audits of state-run food inspections in five states during those states’ budget years spanning 2007 and 2008. And the FDA was unable to say whether audits were conducted at all in 11 additional states during that time, including Georgia and Texas, where salmonella was found in two peanut plants during a wide-ranging peanut recall earlier this year.

Only 14 states saw 100 percent of the audits completed.

The FDA audits are a key part of the federal government’s ability to ensure that food is inspected properly by states that contract with the FDA to perform safety checks. The agency turned over its records on the audits to Republicans on the House Energy and Commerce Committee in response to questioning at hearings earlier this year.

Officials traced the salmonella outbreak to the Peanut Corp. of America’s plant in Georgia and blamed the outbreak for the deaths of at least nine people. Hundreds more were sickened.

Additional numbers for 2006 and 2007 showed that no audits were done in Texas and seven other states during that period.

“The FDA food safety program is a major turnaround project,” said Rep. Joe Barton, R-Texas, who requested information on the state audits with Rep. Greg Walden, R-Ore.

The FDA itself acknowledged as much in a letter sent to Barton this month.

Stephen R. Mason, acting assistant commissioner for legislation at the agency, 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, a report from the inspector general of the Health and Human Services Department, which oversees the FDA, said the agency needed to place a high priority on better evaluating the effectiveness of state inspections of food production facilities, which are done in place of federal inspections through contracts with the FDA.

Part of the agency’s response to that recommendation, put in place several years later, was a standard set by the FDA itself that 7 percent of all state inspections should be audited by the federal agency. In the documents provided to Barton, FDA acknowledges that it has fallen far short of that goal.

A summary of audits for 2007-2008 lists the total number of state contract inspections at 10,218, with only 358 audits completed — about 3.5 percent.

Audits were not done at all in 2007-2008 in California, Iowa, Kansas, Nebraska and Wyoming. In the previous period documented by the agency, 2006-2007, audits were not done at all in Arkansas, Maryland, South Carolina, Tennessee, Texas, Virginia, West Virginia and Wyoming.

Only 9 percent of the promised audits were done in California in 2006-2007, during which time an E. coli outbreak in spinach caused more than 200 illnesses and three deaths.

The data were collected from regional FDA coordinators; the specific time covered varies according to each state’s budget year.

FDA spokeswoman Susan Cruzan says the agency is “evaluating approaches” for improving the audits.

“Although FDA has not been able to fulfill the goal of conducting 100 percent 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,” she said.

Congress has vowed to step up oversight of the FDA, which does the bulk of food safety inspections, in the wake of the peanut recall and several other high-profile recalls in recent years. Several members have introduced bills to overhaul the agency, including proposals to separate its food safety and drug oversight duties, and to significantly increase funding.