FDA says firm sold peanut products before test results

Feb 9, 2009 (CIDRAP News) – Federal officials recently amended their inspection report on the peanut processing plant tied to the current nationwide Salmonella outbreak to say that in a number of cases the company shipped products before getting test results, rather than after getting conflicting results on successive tests.

On Jan 28, the Food and Drug Administration (FDA) reported 12 instances in which the Peanut Corp. of America (PCA) shipped peanut products from its Blakely, Ga., plant after getting an initial positive Salmonella test and then getting a negative result on a second test.

But on Feb 5 the FDA released an amended inspection report showing that in many of these cases, the company had shipped products before receiving any test result. The report still notes two cases, on Jul 18 and 24, 2007, in which PCA shipped products that had tested positive.

All the product lots mentioned in the report tested positive for Salmonella at some point, the FDA said in its latest update on the Salmonella investigation.

Contamination at the Blakely plant is blamed for an outbreak involving 575 cases in 43 states, plus one in Canada, and for probably contributing to eight deaths. As of yesterday, the FDA said 1,790 peanut-containing products had been recalled because of the outbreak.

Products from the Blakely plant were mainly sold to institutions and food services and to other food processing firms, not to retail outlets. But yesterday PCA released a list of products that were produced in 2007 and are subject to the recall. They consist of peanuts sold in cans under the names Casey's, Parnell's Pride, Reggie, and Robinson Crusoe.

The company said it has not sold any products in cans and jars since 2007. It said it was releasing the product list to help any consumers who might still have them on hand. The firm said it had received no reports of illnesses related to the products.

FDA amends inspection report
FDA officials spent more than 2 weeks inspecting the Blakely plant in January after testing of peanut butter in Minnesota and Connecticut tied the facility to the outbreak. The inspections led to the FDA's initial report of cases in which products tested positive for Salmonella initially but were shipped after a second test found no contamination.

In its latest update on the investigation, the FDA said the finding that PCA had shipped products after successive positive and negative Salmonella tests was based on statements from the firm's management. But a more detailed review of documents provided during the inspection indicated that some of the information supplied by the managers did not match up with the documents, the agency said.

The amended report, called an FDA-483, shows numerous cases in which PCA ordered tests of peanut products but then released one or more shipments before receiving the test results. The report also says that on Jul 18 and 24, 2007, the company released shipments of chopped peanuts "on or after the positive Salmonella results were obtained."

"It is important to note that for all lots identified in the FDA-483 (original and amended), the firm received positive Salmonella test results for the products shipped," the FDA update states. "For example, in some situations the firm received a positive Salmonella test result, followed by a later negative result, and then shipped the products.

"In some other situations, the firm shipped the products before it had received the positive test results. For these, sometimes the firms received a subsequent negative test, and sometimes no additional testing appears to have been done."

All of the cases covered in the FDA inspection report are classified as failures to manufacture under conditions needed to minimize the potential for growth of microorganisms. Products cited in the report include peanut paste, peanut butter, peanut meal, chopped peanuts, peanut granules, and oil-roasted peanuts.

USDA suspends firm
In other developments, the US Department of Agriculture (USDA) recently announced it was barring PCA from doing business with the federal government for at least a year. Last week it was reported that PCA products had been used by USDA-supported school lunch programs in California, Idaho, and Minnesota.

"Effective immediately, PCA is excluded from participating in government contracts or subcontracts, as well as federal nonprocurement programs," the USDA said in a Feb 5 statement.

The suspension will be in effect for a year, but the agency is proposing to extend it to 3 years, the statement said. It covers PCA and its subsidiary, Tidewater Blanching LLC. The company has 30 days to submit information opposing the suspension.

"The actions of PCA indicate that the company lacks business integrity and business honesty, which seriously and directly hinders its ability to do business with the federal government," David Shipman, acting administrator of USDA's Agricultural Marketing Service, said in the statement.

The Washington Post reported on Feb 6 that PCA had sold 32 truckloads of roasted peanuts and peanut butter to the government for its free school-lunch program for poor children. Schools in California, Idaho, and Minnesota received the products from January to November 2007, a USDA official told the Post.

See also:

FDA update on investigation
http://www.fda.gov/oc/opacom/hottopics/salmonellatyph.html

Feb 5 USDA news release about suspending business with PCA

FDA's list of products recalled because of the outbreak
http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm

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