On Monday, the U.S. Drug and Food Administration suspended the food facility registration of Sunland Inc., the beleaguered Texas-based producer of nuts and nut and seed spreads.
This was the FDA’s first use of its registration suspension authority under Food Safety Modernization Act of 2011, according to a news release.
The act enables the agency to take such action when food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious health consequences or death to humans or animals. When a facility’s registration is suspended, it is prohibited from producing or distributing food.
Sunland’s woes began in late September when the first trace of a salmonella strain was found in a jar of Trader Joe’s Valencia peanut butter. Since then the company has been linked to an outbreak of the rare Salmonella Bredeney that has sickened 41 people in 20 states, the FDA said.
That, coupled with Sunland’s history of violations, led federal officials to make the suspension decision.
A review of the food company’s product testing records showed that 11 product lots of nut butter showed the presence of 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’s own testing program identified as containing salmonella was distributed by the company to consumers.
Additionally, during its inspection of the plant in September and October, the FDA found salmonella in 28 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.
Investigators found company employees improperly handled equipment, containers and utensils used to hold and store food. Those handling peanut products wiped gloved hands on street clothes and other times failed to wash their hands or change gloves. There was a lack of hand-washing sinks and employees had bare-handed contact with ready-to-package peanuts.
There were no records documenting the cleaning of production equipment, the FDA said. The super-sized bags used by the firm to store peanuts were not cleaned, despite being used for both raw and roasted peanuts.
There was a leaking sink in a washroom that resulted in water accumulating on the floor, and the plant is not built to allow floors, walls and ceilings to be adequately cleaned.
Finally, investigators found raw, in-shell peanuts were found outside the plant in uncovered trailers. Birds were observed landing in the trailers and the peanuts were exposed to rain, which provides a growth environment for salmonella and other bacteria. Inside the warehouse, facility doors were open to the outside, which could allow pests to enter.
Last month, Sunland, the nation’s largest producer of organic nut butters, said it was continuing to accept fresh peanut harvests from farmers and had planned to begin producing peanut butter again this week.
The company’s products had been found in stores all over the nation for more than two decades, including Safeway, Costco and Target. The recall eventually climbed to 240 products, including some bird feed and novelty peanut butters, according to the FDA.
The suspension order gives Sunland a right to an informal hearing. The FDA may require the company to submit a plan to address the immediate problems and to prove a sustainable solution to its safety problems, allowing reinstatement only after the company can prove its facilities meet sanitation requirements.