FDA uses new FSMA powers to suspend registration of organic peanut processing firm
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WASHINGTON, November 26 - As the Food and Drug Administration (FDA) suspended the food facility registration of Portales, New Mexico-based Sunland Inc. Monday, worldwide concerns began to spread about the safety of the organic peanut and almond butter products believed contaminated with salmonella linked to sickening 41 people in several states.
Once a facility's registration is suspended, that facility is prohibited from introducing food into interstate or intrastate commerce.
“The fact that peanut butter made by the company has been linked to an outbreak of Salmonella Bredeney that has sickened 41 people in 20 states, coupled with Sunland's history of violations led FDA to make the decision to suspend the company's registration,” according to the FDA.
The FDA action was the first exercise of its expanded powers since the tougher food inspection law, the Food Safety Modernization Act (FSMA), went into effect Jan. 4, 2011.
China on Friday said it will suspend imports of nuts produced by Sunland and the United Kingdom's Food Standards Agency (FSA) issued a warning, according to published reports, while the Canadian Food Inspection Agency (CFIA) has warned the public not to consume, sell or serve certain Sunland products. Salmonella, and Salmonella Bredeney tied to Sunland's outbreak, is a pathogen, which can cause serious adverse health consequences and even death.
An FDA review of Sunland Inc.'s product testing records showed that 11 product lots of nut butter tested positive for salmonella between June 2009 and September 2012. Between March 2010 and September 2012, at least a portion of eight product lots of nut butter that Sunland Inc.'s own testing program identified as containing salmonella was distributed by the company to consumers.
Additionally, during an FDA inspection of the plant in September and October 2012, salmonella was found in 28 environmental samples (from surfaces in production or manufacturing areas) and in 13 nut butter product samples and one product sample of raw peanuts. Four of the peanut butter product samples showed the presence of the outbreak strain of Salmonella Bredeney.
“At no time in its twenty-four year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms,” Sunland president and CEO Jimmie Shearer said on the company's website.
The FSMA also grants the FDA power to suspend the registration of companies along the supply chain, as well. It was unclear at press time if any companies that used peanut or almond butter products from Sunland would also face suspension.
However, other companies, including a Colorado ice cream company and a company that produced chocolate bars made with Sunland peanuts, recalled their products following Sunland's initial recall in September.
In its written response to the FDA Form 483 that was issued at the end of the most recent FDA inspection, received by FDA on November 9, 2012, Sunland pledged to take a “number of corrective actions,” according to FDA's suspension order. The FDA said that Sunland's response omitted “significant details regarding planned physical repairs and corrective actions,” adding: “It will be necessary for FDA to evaluate the completed corrective actions on site to assure their adequacy.”
Sunland will be given an opportunity for an informal hearing within two business days of the Monday suspension on the actions required for reinstatement of the facility's registration. If the FDA determines that the suspension remains necessary, the FDA will require Sunland, Inc. “to submit a corrective action plan to address the immediate problems and to implement a sustainable solution to those problems in a sound scientific manner.” The FDA will reinstate Sunland, Inc.'s registration only when FDA determines that the company has implemented procedures to produce safe products.
Following a delay from its updated initial biennial renewal period - a change from the once-only registration period, originally scheduled to open Oct. 1, the FDA opened its biennial registration renewal for food facilities October 22, 2012.
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