U.S. District Judge William P. Johnson of the District of New Mexico has signed a consent decree imposing requirements on Sunland Inc., a manufacturer and distributor of peanut products linked to an outbreak of Salmonella Bredeney, to keep potentially harmful products from entering the marketplace, the U.S. Food and Drug Administration said today.
On Nov. 26, 2012, the FDA suspended Sunland’s registration because it did not provide enough assurance that existing problems would be corrected. This was the first use of the agency’s authority to prohibit a food facility from introducing product into interstate or intrastate commerce, an authority granted to the agency under the FDA Food Safety Modernization Act of 2011.
“When the FDA suspends a facility’s registration, consumers can be assured that its products will stay off the market until the agency determines that they can be safely produced,” said Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor.
Based on the requirements of the consent decree, signed on Dec. 21, 2012, FDA has determined that adequate grounds no longer exist to continue the suspension actions and will vacate the suspension order and reinstate Sunland’s food facility registration.
However, the company cannot process or distribute food from its peanut butter plant or peanut mill plant in Portales, N.M., until it has complied with the consent decree’s requirements to the agency’s satisfaction. Sunland must receive written authorization from the FDA prior to resuming operations at both its peanut butter and peanut mill plant.
The consent decree requires that Sunland retain an independent sanitation expert to develop a sanitation control program that the company must then implement. The requirements also include compliance with the cGMP regulations.
In addition, for the peanut butter plant, the company must conduct environmental monitoring and testing to ensure that disease-causing organisms are not present in the facility or in its finished foods and must have comprehensive inspections conducted by an independent sanitation expert.
The consent decree permits Sunland to receive, hold, and distribute raw, unshelled peanuts from its storage buildings because the raw, unshelled peanuts are bound for processing facilities that include a “kill step” to eliminate Salmonella and other pathogenic bacteria.
The need for a consent decree stems from evidence linking Sunland to an outbreak of Salmonella Bredeney that sickened 42 people in 20 states, coupled with the company’s history of violations, which led to suspension of the facility’s registration.
FDA investigators collected environmental and finished-product samples at the Sunland facilities in Portales between mid-September and mid-October. Subsequent analysis determined that Salmonella Bredeney with a DNA signature identical to the strain responsible for the outbreak was present in the samples. Additionally, the investigators documented significant deviations from the agency’s current good manufacturing practice (cGMPs) regulations, including insanitary conditions and improper manufacturing practices.
Salmonella Bredeney is a type of bacteria that commonly causes diarrhea, fever, and abdominal cramps when eaten. Most people recover without treatment in less than a week, although some experience diarrhea so severe that they need to be hospitalized.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human and animal use, and medical devices.
The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
