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Rapid Response Helps Contain Outbreak Linked to Peanut Butter

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Scientists at FDA's laboratory in the Denver District office analyzed samples taken at the Sunland peanut processing and nut butter production plants. For more detailed captions and the high-resolution photos, go to Flickr.

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When public health agencies recognized the signs of an emerging Salmonella outbreak in early September 2012, they could tell that the bacterium was contaminating a food popular with children.

And there aren't many foods more loved by kids than peanut butter.

The outbreak of Salmonella Bredeney in peanut butter produced by one company has infected 41 people in 20 states, according to the Centers for Disease Control and Prevention (CDC). The majority of those who have fallen ill with diarrhea, fever and abdominal cramps are children under age 10.

More people would have fallen ill if not for fast action by federal and state public health agencies.

Those actions culminated on Nov. 26, 2012 with the Food and Drug Administration's suspension of the food facility registration for Sunland Inc., of Portales, N.M. Sunland produced the peanut butter product linked to the outbreak—Trader Joe's Creamy Salted Valencia Peanut Butter made with Sea Salt.

This is FDA's first use of the suspension-of-registration authority since the authority became effective in July 2011. Provided by the FDA Food Safety Modernization Act, this authority enables FDA to suspend a facility's registration when the agency has determined, in part, that a food that is manufactured, processed, packed, or held by a facility is likely to cause serious illness or even death.

Sunland will not be able to distribute food from this facility until the suspension is lifted.

Donald Zink, Ph.D., a senior science advisor at FDA, says that peanut butter is particularly vulnerable to Salmonella contamination. "Salmonella is in the soil and peanuts come right out of the ground," he says.

Great care has to be taken to produce peanut butter in a "highly sanitized" environment, he says. Special protections have to be in place to make sure the finished product isn't contaminated after the nuts are roasted, the only "kill step" for the Salmonella.

However, FDA inspectors report finding insanitary conditions at Sunland, including conditions that likely resulted in cross-contamination between raw and roasted peanuts, such as unclean equipment that comes into contact with food, employees who didn't wash their hands or wear clean gloves, and the use of totes to transport both raw and roasted peanuts without any cleaning or sanitizing process.

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Agencies Joined Forces

In early September, the FDA's Coordinated Outbreak Response and Evaluation (CORE) Network spotted signs of trouble.

Jennifer Beal, MPH, a CORE epidemiologist, says early reports for this cluster of Salmonella Bredeney showed that many of the ill were children. "Whenever we see that something is primarily affecting children, we mobilize quickly. It's a big red flag," notes Beal.

FDA and CDC joined forces with state and local public health and agriculture agencies. Food exposure data started coming in from the states to CDC, and it wasn't long before this information pointed to a common source, Trader Joe's Valencia Creamy Peanut Butter.

This peanut butter was produced by a contract manufacturer whose identity during the early phases of the investigation was unknown. CORE experts researched U.S. production of Valencia peanuts and discovered that almost 100% of this crop is grown in and around Portales, NM.

FDA's district offices—part of the Office of Regulatory Affairs (ORA), the agency's field operations—were informed about the investigation. The response from the Denver District Office, which covers New Mexico, was that a consumer safety officer was already in a plant in Portales that was known to make peanut butter for Trader Joe's, conducting an inspection.

It was the Sunland plant, which FDA soon learned was the sole producer of the peanut butter linked to the outbreak. Five more FDA consumer safety officers were soon dispatched to join the investigation.

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At the Plant

Commander William Boden, an officer in the Commissioned Corps of the U. S. Public Health Service who serves as emergency response coordinator for the Denver District, says FDA consumer safety officers collected hundreds of environmental swabs from the equipment, floors and other surfaces in the facilities and dozens of samples from finished products. The officers also inspected Sunland's records.

The samples were sent to FDA's Denver District laboratory, where Salmonella that matched the outbreak strain was found in both the environment and finished products, says Boden.

This was not the first time that FDA has found problems at Sunland. Objectionable conditions were noted during FDA inspections in 2007, 2009 and 2010. Sunland's history of violations led FDA to return on multiple occasions to re-inspect the company's facility and procedures. Sunland's proposed actions in response to FDA's September 2012 inspection do not provide enough assurance that existing problems have been corrected or will be corrected in the future.

One of the challenges faced by ORA teams across the country was following the trail of the many food products that include Sunland-produced nuts and nut butters.

FDA worked with Sunland to quickly get products off the shelf and facilitate voluntary recalls. Based on the number of products contaminated or exposed to conditions in which they may have been contaminated, Sunland expanded the recalls to include hundreds of products. Distribution of those foods was widespread; they were sold in retail outlets across the country.

According to CDC, the last reported onset of illness traced to products produced by Sunland was Sept. 21, 2012. However, CDC notes that some consumers might not know that they have a recalled product. For a list of recalled products, visit FDA's web page on this outbreak. If you've got one of these products, throw it out or return it to the store for a refund.

Even with the Sunland recalls, Zink says, "The likelihood that you will get contaminated peanut butter is very low."

He explains, "The vast majority of peanut butters in this country are made by very competent companies that know what they need to do and take proactive steps to avoid contamination."

Nov. 29, 2012

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