The consent decree, which was signed on Dec. 21, acknowledges that adequate grounds no longer exist to continue the suspension actions and will vacate the suspension order and reinstate Sunland’s food facility registration. But the decree also notes that 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 F.D.A.’s satisfaction. Sunland must receive written authorization from the F.D.A. prior to resuming operations at both its peanut butter and peanut mill plant.
The suspension of Sunland’s operations was the first use of the F.D.A.’s authority to prohibit a food facility from introducing product into interstate or intrastate commerce, an authority granted to the agency under the F.D.A. Food Safety Modernization Act of 2011.
“When the F.D.A. 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 Michael Taylor, deputy commissioner for foods and veterinary medicine at the F.D.A.
Under terms of the decree, Sunland must 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 (current good manufacturing practices) 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.