Brothers William and Scott McGreevy said in March that they’d reach a “quick resolution” to the dispute between their Wichita company and the U.S. Food and Drug Administration (FDA). On Wednesday, that prediction came true when the U.S. District Court for Kansas ordered a permanent injunction against the company, Native American Enterprises LLC, vice president and co-owner William N. McGreevy; and production manager Robert C. Conner.  The McGreevy brothers are associated with the Lower Brule Sioux Tribe. While the beans and sauces that concern FDA because of possible Listeria contamination inside the NAE facility at 230 N. West Street in Wichita have apparently not left the building, the permanent injunction now prevents distribution of those food products. NAESign_406x250The order covers all in process and finished food products other than meat and packaged products. NAE in March told Food Safety News the beans and sauces that fall under FDA’s jurisdiction are the smaller part of its business. The meat products fall under the jurisdiction of USDA’s Food Safety and Inspection Service. The rest of the court order pretty much follows standard FDA requirements. NAE and its owners, without admitting any liability, agreed to provide a complete inventory of the targeted products to FDA, and then help the agency destroy them. If NAE wants to re-enter that line of business, it must notify FDA 90 days ahead of time and then submit to a familiar set of requests including hiring outside independent experts and laboratory services to help eradicate the Listeria problem from inside the facility. The Department of Justice (DOJ) filed the complaint against NAE with the Kansas federal court on March 21 at FDA’s request. It charged NAE with producing refried beans and sauces that are adulterated in that they have been prepared, packed and/or held under insanitary conditions whereby the food may have become contaminated with filth or have been rendered injurious to health. The complaint said the insanitary conditions include the presence of Listeria Monocytogene (L. mono) in NAE’s facility and insanitary employee practices. “Listeria monocytogenes is a very dangerous bacteria, and its presence in a food production facility is of great concern,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Department of Justice’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to ensure a safe food supply.” On May 27, the parties filed a consent decree of permanent injunction, by which the defendants agreed to resolve the litigation. The consent decree of permanent injunction, entered by the district court, requires the defendants to cease all manufacture or distribution of food (including RTE refried beans and sauces) other than meat products. In the event that defendants intend to resume the manufacture or distribution of food other than meat products, they will only be allowed to do so under the order with FDA approval and under strict supervision. USDA’s Food Safety Inspection Service (FSIS) conducts daily on-site operations inspections at NAE under the Federal Meat Inspection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act. FDA inspected NAE’s facility in Wichita in August 2015, collected environmental samples, and observed numerous insanitary practices, including the defendants’ failure to manufacture and package food under conditions necessary to minimize microorganism growth, take necessary precautions to protect against contamination and maintain buildings in good repair. FDA observed rain water leaking through the roof in the packaging room, directly above where NAE employees packaged ready-to-eat (RTE) refried beans. In addition, FDA observed cracks and holes in the walls and floor junctures that allow water and debris to collect, prohibit adequate cleaning and could harbor Listeria, according to the complaint. FDA also had inspected NAE’s facility twice in 2014. As alleged in the complaint, FDA collected environmental samples during RTE refried beans production during each of the 2014 inspections and found Listeria in the facility. In addition, as alleged in the complaint, FDA also observed a failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing. Listeria monocytogenes thrives in moist environments, such as food-manufacturing environments. Unless proper precautions are taken, the pathogen may become established and grow. It is difficult to eliminate once it becomes established in a food-manufacturing environment. Listeria monocytogenes is capable of surviving and growing at refrigerated temperatures and in high-salt environments. The complaint states Listeria monocytogenes is a significant public health risk in RTE refried beans and sauces. (To sign up for a free subscription to Food Safety News, click here.)