Harkin: FDA oversight does not work

From the office of Sen. Tom Harkin:

Reacting to the news that yet another Peanut Corporation of America plant was closed after Salmonella was detected at the facility, Senator Tom Harkin (D-IA) today said that FDA oversight of state inspections of food processing facilities does not work. Previous media reports have shown that this plant may have gone four years without a food safety inspection, a fact confirmed by FDA officials last week. The Salmonella outbreak has killed eight and sickened 600 nationwide, including three in Harkin’s home state of Iowa.

“Hundreds of people sickened and in the worst cases, lives lost – all because of a food-borne illness. We’ve been here before, and we cannot afford to be here again,” said Harkin. “This inspection systems does not work. Our committee heard firsthand of the lapses last week and now we are seeing the results of food processing facilities that go uninspected.”

At a hearing before the Senate Agriculture Committee last week, which Harkin chairs, FDA officials testified that the Peanut Corporation of America’s own testing found 12 incidents of Salmonella at the plant since 2007. Under law, the company does not have to report these findings to the FDA and despite these warnings, the last time federal inspectors were sent to the plant, prior to the recent Salmonella outbreak, was in 2001.

Following the hearing, Harkin called for FDA to release to Congress records detailing the inspection report from the Georgia state Department of Agriculture to conduct food safety inspections of the Peanut Corporation of America plant. The FDA has yet to submit the documents. Today, Harkin sent a letter to the agency pressing them for the documentation.

“Before another American gets sick, before another child eats a peanut product that may be contaminated, Congress must get to the heart of this matter,” he concluded. “I urge the FDA to release the records on state contracts immediately.”

The full text of the letter follows.

February 11, 2009

Dr. Stephen Sundlof

Director, Center for Food Safety and Applied Nutrition

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20903

Dear Dr. Sundlof:

The record of the hearing of this Committee on Thursday, February 5, 2009, including your testimony at that hearing, shows that prior to the recent Salmonella outbreak, FDA last inspected the Blakely, GA Peanut Corporation of America plant in 2001. FDA contracted with the state of Georgia to inspect the plant in 2006. During the time period from 2001 to 2006, the plant was not inspected by FDA but was inspected by Georgia state authorities, but not under direction of or under contract with FDA. In 2007 and 2008 shipments that PCA testing showed positive for Salmonella left the plant and made their way into the food supply. When the FDA inspected the plant in January 2009, several violations of processing plant cleanliness standards were discovered. According to FDA records, was this the condition of the plant during the time that the FDA contracted with the state of Georgia for inspections?

During the hearing, I requested from FDA copies of relevant records and documents involving inspections by Georgia state authorities. Please provide documents covering the period from FDA’s last inspection in 2001 forward and which include all reports or communications involving inspections of the plant by Georgia state authorities, including dates and the number of inspections, all communications and reports regarding such inspections that are in the possession of FDA, and PCA internal laboratory test results. For each document, please specify when the FDA received these documents. What findings did the reports to the FDA concerning the inspections contain and were more corrective actions prescribed by the FDA?

Additionally, I request the inspection report from 2009 for PCA’s plant in Plainview, TX and laboratory test results resulting from this inspection. What findings did the reports to the

FDA concerning the inspections contain and were more corrective actions prescribed by the FDA?

Thank you for your testimony at the hearing and for your follow-up to provide these requested documents.Sincerely,

Tom Harkin

Chairman