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First company shut down by FDA under new food-safety law

WASHINGTON — If produce companies were questioning whether the Food & Drug Administration would use a new enforcement tool and shut down a food plant under the FDA Food Safety Modernization Act, ask nut processor Portales, NM-based Sunland Inc.

Sunland became the first business to have its food facility registration suspended by the FDA, thereby shutting it down, after its testing records showed it shipped Salmonella-positive products, the FDA said in a Nov. 26 letter from Commissioner Margaret Hamburg to Sunland President Jimmie Shearer.

Not only was it the first business to be affected by the FDA’s new authority, it was also the subject of a widely publicized press release by the FDA.

Sunland has been under investigation for a Salmonella Bredeney outbreak involving more than 40 people and tied to tainted “Trader Joe’s” brand Valencia creamy salted peanut butter. As of last month, Sunland has recalled 240 products processed since 2010, and investigators found Salmonella in raw peanuts and in environmental samples at the plant.

Under the food-safety act, the FDA has the authority to suspend a food facility’s registration — effectively shutting it down — if the FDA determines food received or held at a facility has a reasonable probability of causing serious adverse health consequences or death. No food from that facility may be shipped in interstate commerce nor can food be shipped to that facility or sent overseas.

Sunland said that it was surprised by the FDA’s move to suspend its registration.

In a Nov. 27 statement, the company said that it shut down its shelling operations prior to initiating a voluntary recall Sept. 24 and had hoped to restart Nov. 26, once the FDA reviewed its Nov. 20 corrective action plan.

“Sunland expected that any agency concerns with its plans would be part of the ongoing dialogue with the agency,” the company said. “The agency’s order suspending Sunland’s registration on November 26, 2012, was unexpected and the company is disappointed by this development.”

Commissioner Hamburg’s letter said that the FDA was not pleased with Sunland’s initial response to FDA’s inspection report, saying it “omits significant details regarding planned physical repairs and corrective actions, and the adequacy or effectiveness of these corrective actions cannot be determined based on the information provided in the response.”

Sunland said it plans to take all appropriate measures for the safe processing and handling of raw peanuts in its shelling plant and nut butter products in its peanut butter plan.

In the meantime, the company has become a test case under the FDA’s authority to suspend a U.S. company’s registration.