DeLauro: audit FDA oversight of state inspection contracts

From the office of Rep. Rosa DeLauro

Congresswoman Rosa L. DeLauro (Conn. -3), in a letter to the Inspector General at the Department of Health and Human Services, called for an audit of the Food and Drug Administration’s oversight of state inspection contracts. The recent salmonella outbreak involving peanut butter has raised serious questions about whether the agency is effectively overseeing its state contracts. While in 2007 and 2008 the FDA noted that the regional office in charge of the plant in Blakely, Georgia, which appears to be at the center of the outbreak, met or exceeded the minimum audit rate as required, FDA inspections after the outbreak was underway found more serious problems.

“I am very concerned that the recent salmonella outbreak involving peanut butter products has exposed a continuing problem at the FDA regarding oversight of the agency’s state inspection contracts. This is a weakness at FDA that the Inspector General’s office at the Department of Health and Human Services first reported on in June 2000.” DeLauro writes in the letter.

“It is imperative that your office conduct an updated audit to determine whether the FDA is overseeing its state contracts adequately,” the letter continues. “It is critical that we obtain this information in a new audit so that measures could be taken to prevent another major food-borne illness outbreak.”

Below is the text of the letter.

February 13, 2009

Daniel R. Levinson

Inspector General

Office of Inspector General
U.S. Department of Health and Human Services
Room 5541 Cohen Building
330 Independence Avenue, S.W.
Washington, D.C. 20201

Dear General Levinson:

I am very concerned that the recent salmonella outbreak involving peanut butter products has exposed a continuing problem at the Food and Drug Administration (FDA) regarding oversight of the agency’s state inspection contracts. This is a weakness at FDA that the Inspector General’s office at the Department of Health and Human Services first reported on in June 2000. I strongly urge your office to perform an updated audit to the June 2000 report to determine whether the FDA has improved upon its performance and has followed through with the list of recommendations that were outlined by the IG in 2000.

In the June 2000 report, the HHS Inspector General’s office concluded that the Food and Drug Administration (FDA) failed to oversee its state inspection contracts vigorously. Specifically, the IG found that the FDA audits very few state inspection contracts, and that 14 of its 17 regional offices had no formal criteria for reviewing states’ performance.

During its investigation into the salmonella outbreak, the FDA indicated that the yearly minimum audit rate for the food contract program is seven percent of the number of contract inspections found in the contract. The implementation of this requirement is conducted through both contract audits and joint inspections. For 2007 and 2008, FDA noted that the regional office in charge of the plant in Blakely, Georgia that reportedly is the center of the outbreak, met or exceeded the minimum audit rate as required.

There appeared to be a problem with the oversight of this particular contract because of the failure of these inspections to uncover glaring unsanitary conditions that were discovered later after the salmonella outbreak. Given the varying standards of inspection programs across the country, it is probable that there are other states with similar situations.

This is why it is imperative that your office conduct an updated audit to determine whether the FDA is overseeing its state contracts adequately. If you move forward with this audit, I urge that your updated report include the following:

· An audit of all human food and animal feed safety inspection contracts that FDA has with state agencies for the past five years.

· A detailed outline of the services the state agencies provided to the FDA.

· An assessment of the quality and timeliness of information provided to FDA by the state agencies.

· An assessment of how FDA headquarters personnel used the information transmitted by state agencies.

· An assessment of FDA’s information technology capability to collect information transmitted by state agencies.

· An assessment of the training provided by FDA to state agencies tasked with inspections.

· An assessment of the performance audits conducted by FDA of the state agencies with which the agency contracted and an estimate of the percentage of inspections that the FDA conducts jointly with state agencies to oversee the state’s ability to enforce FDA food safety standards.

· In the June 2000 report, the IG stated that the FDA did not use risk-based inspection guidelines on state inspections for which the agency contracts. This new audit should examine whether the FDA began implementing risk-based inspection guidelines subsequent to the IG report.

It is critical that we obtain this information in a new audit so that measures could be taken to prevent another major food-borne illness outbreak. Thank you very much for your consideration of this request.

Sincerely,

ROSA L. DeLAURO

Chairwoman

House Appropriations Subcommittee on Agriculture
Rural Development, Food and Drug Administration,

and Related Agencies