Setton disputes FDA claim that it knew of Salmonella
by Joan Murphy | May 27, 2009
WASHINGTON -- From October 2008 to March 2009, Setton Pistachio of Terra Bella Inc., based in Terra Bella, CA, continued to process roasted pistachios and ship product despite the fact that four laboratories detected Salmonella on eight occasions, according to an inspection report by the Food & Drug Administration.
After a 17-day inspection, the FDA delivered the April 30 report, known as the 483 form, to the company with a list of findings. The company failed to monitor roasting temperatures before January 2009, ran raw and roasted products on the same equipment, and did not have an air-flow system to prevent contamination between the raw and roasted nut products, according to the FDA's five-page report.
Kraft Foods, a Setton customer, said that one of its processors found sporadic contamination on a mixed-nut product for months but could never pinpoint the source until it finally identified pistachios. The food processor notified the FDA March 24, which sparked the recall of millions of pounds of pistachios and more than 650 different foods.
The FDA found Salmonella Montevideo, one of the four strains detected on Kraft Foods' mixed-nut product, during an inspection of the plant. One finding in the FDA's inspection report is likely to gain the most attention, particularly on the heels of the Peanut Corp. of America scandal. The FDA said that the company continued processing the nuts without changing its operation after four different laboratories detected Salmonella on eight different occasions.
"Your firm continued to distribute roasted pistachio products after the first private laboratory sample of your roasted pistachio product was reported positive for Salmonella and did not evaluate the adequacy of your roasting process to assure that your roasted pistachio products were free of microorganisms of public health significance," said the 483 report.
The potentially contaminated in-shell, roasted nuts were shipped in October before the firm received the private laboratory test results, said the FDA. The customer returned the shipment and the nuts were re-roasted and blended with other pistachios. On March 12 and March 18, shipments were sent out to customers that tested positive for Salmonella.
"When your firm was notified by your private laboratories of sample test results for your roasted pistachio products that were positive for Salmonella, your firm did not have procedures in place to assess the most appropriate response to these reported positive samples," said the FDA report.
But Mia Cohen, Setton Pistachio's chief operating officer, said that the company never knowingly shipped potentially contaminated pistachios. "All pistachios which tested positive were either reconditioned or held in quarantine and never hit the marketplace," she said in a statement.
After receiving the first positive test in October 2008, Ms. Cohen said that the company hired the American Council for Food Safety & Quality, also known as DFA, to review the operation. It conducted hundreds of tests from October to February and found no evidence of Salmonella in the facility. "There was never a suggestion from DFA not to ship," Ms. Cohen said in the statement.
"We adamantly disagree with portions of the 483 [report] and we have responded accordingly," she said.
Setton has made physical changes to the facility, redesigned its processes and conducted an extensive review of its operations.
"We have invested significant resources to thoroughly modernize and redesign our processing facility in California to address all of the concerns raised by FDA as well as proactively making additional improvements," she said.
Setton is not the only company likely to undergo processing changes. Western Pistachio Association Executive Director Richard Matoian told The Produce News that the industry is working on drafting new Good Agricultural Practices and new Good Processing Practices.
These changes are being worked on through the Administrative Committee for Pistachios, the federal marketing order that sets quality standards for pistachos, he said.
"GAPs and GMPs have been in place since the year 2000, and based upon the incident, they are being revised to incorporate new knowledge that has been gained," he said in a May 27 e-mail.