Sunland Inc., the New Mexico company whose peanut butter was linked to a 20-state Salmonella outbreak last fall, has resumed operations after a federal judge signed a consent agreement dictating conditions under which the company will be allowed to process or distribute its products.
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The requirements, requested by the FDA and signed by U.S. District Judge William P. Johnson, include retaining an independent sanitation expert and conducting regular environmental monitoring.
In late November of last year, the FDA for the first time used its powers under the Food Safety Modernization Act to suspend Sunland’s food facility registration after inspections a month earlier suggested that the company knowingly put tainted products into commerce.
“The FDA found that between June of 2009 and August of 2012, Sunland Inc. had distributed, or cleared for distribution, portions of 11 lots, or daily production runs, of peanut or almond butter after its own testing program identified the presence of at least one of nine different Salmonella types,” said an FDA release.
Having the power to pull food facility registrations is a “huge culture change” for the FDA, said Robert Buchanan, PhD, director of the Center for Food Safety and Security Systems at the University of Maryland. “It’s a significant new authority, and the burden of proof is much less than, say, getting a court injunction while having essentially the same effect. Often, with an injunction, you’re specifically enjoined to do or not do certain things, while if they pull your registration, you’re just not allowed to put food into interstate commerce.”
Under the consent decree, the FDA will lift the suspension of Sunland’s registration, but they could potentially have left it in place for an indefinite amount of time. “Right now, the limit to the length of registration suspension is undefined by FSMA,” said Dr. Buchanan. “It’s a power that’s equivalent to that of the USDA’s Food Safety Inspection Service, where they can simply pull the inspectors and without those, you don’t get to release anything into commerce.”
The initial recall of the Sunland peanut butter, announced in September 2012, was expended multiple times and ultimately included nearly 250 products bearing more than 100 different brand names.