F.D.A. outlines possible causes of pistachio recall

by Keith Nunes
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TERRA BELLA, CALIF. — A failure to adhere to good manufacturing practices may be at the heart of the Setton Pistachio of Terra Bella, Inc. recall, according to a Form 483 inspection report made public by the Food and Drug Administration. The company disputes the F.D.A.’s findings.

During the F.D.A. inspection, which took place between March 26 and April 30, the inspectors noted that the company failed to manufacture, package and store foods under conditions necessary to minimize the potential for growth of microorganisms; failed to pasteurize raw materials that may have been contaminated with pathogens; the facility lacked an air-flow system to prevent cross-contamination of finished product; the company failed to take effective measures to protect finished products from contamination; and the company failed to maintain equipment in a manner that protects against contamination.

"Our company never knowingly shipped pistachios potentially contaminated with Salmonella," said Mia Cohen, chief operating officer of Setton Pistachio of Terra Bella, Inc. "All pistachios that tested positive were either reconditioned or held in quarantine and never hit the marketplace. Immediately after receiving the first positive in October 2008, our company hired the American Council for Food Safety and Quality — known as D.F.A. here in California — to review our operation and they conducted hundreds of tests from October to February and could find no evidence of Salmonella in our facility. There was never a suggestion from D.F.A. not to ship.

"We adamantly disagree with portions of the 483 and we have responded accordingly. Nevertheless, we share the government's commitment to food safety and have taken aggressive steps to ensure the safety and wholesomeness of our product. There have been no illnesses conclusively linked to the pistachio recall, and in our 23-year operating history we had never received an illness related complaint prior to the recall."

Specifically, the F.D.A. report said that after receiving sample analysis results for roasted pistachio products that were positive for Salmonella beginning in October 2008, Setton Pistachio of Terra Bella continued to process roasted pistachio products under the same processing conditions until March 2009.

"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 report. "Your firm also did not attempt to determine potential routes of cross-contamination within your facility between raw pistachios and roasted pistachios after your firm began receiving positive Salmonella sample results for your roasted pistachio products."

At least eight times the company was informed of Salmonella-positive test results by third-party laboratories. The F.D.A. said Setton Pistachio of Terra Bella lacked the quality control operations and procedures for taking the actions necessary to prevent food from being adulterated.

In early April the company announced it was recalling all lots of roasted in-shell pistachios and roasted shelled pistachios that were produced from nuts harvested in 2008 due to possible Salmonella contamination.

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