A federal court has shut down the Walton, NY, creamery that last year was the source of a multistate listeriosis outbreak that infected eight people in four states with listeriosis, resulting in two deaths.
In a civil action, U.S. District Court Judge Brenda Sannes permanently enjoined Vulto Creamery LLC and its owner Johannes H. Vulto from any further manufacturing or distribution of food. The U.S. Food and Drug Administration has found Vulto’s ready-to-eat cheeses are adulterated with the bacterium Listeria monocytogenes (L. mono).
New court documents say that in the aftermath of the deadly outbreak, federal officials came to the conclusion that Vulto lacked the knowledge and understanding to make corrections and become compliant with legal requirements.
Vulto admitted there was much he did not understand, including the significance of environmental sampling, positive results or the need for a root cause investigation. He offered only “several minor corrective actions.”
“L. mono is a serious health threat that can prove fatal,” said acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “Consumers should be able to trust that the food they buy is safe, and we will continue working with FDA to take action against manufacturers that employ substandard practices.”
At FDA’s request, the Department of Justice (DOJ) filed for the permanent injunction in U.S. District Court for the Northern District of New York on March 19. The judge signed the order on March 30, and DOJ announced the action on today, April 2.
“The presence of this dangerous bacteria at a cheese manufacturing facility in Upstate New York is of grave concern,” said Grant C. Jaquith, U.S. Attorney for the Northern District of New York. “We will continue to use all available tools to ensure that our food supply is safe and violations of laws protecting public health are addressed.”
Vulto Creamery’s soft raw milk cheese was responsible for last year’s only multistate outbreak of listeriosis in the U.S., according to the federal Centers for Disease Control and Prevention in Atlanta.
Five of the eight ill people in the outbreak were New York residents. A Florida resident became sick after eating the cheese during a visit to New York. The outbreak involved one resident each in Connecticut and Vermont, and those were the two that died.
When Vulto Creamery was identified as the source of the listeriosis outbreak, the recalls began. At FDA’s urging, Vulto first agreed to recall its Ouleout cheese on March 3, 2017. Four days later on March 7, 2017, Vulto expanded the recall to include all soft and semi-soft cheese. After further discussion with FDA, all Vulto cheese products were added to the recall on March 11, 2017. It further agreed on March 17, 2017, to destroy all cheese in its inventory or that was returned in the recall, and did so on April 5, 2017.
The new court documents shed new light on the outbreak investigation, including the many violations FDA found during its March 2017 inspection of the Vulto Creamery.
Investigators found the Vulto employees did not wash their lower or upper arms before submerging them in whey to stir and break up in-process cheese curds. One of those employees had multiple cuts and abrasions on his arms. Black mold was also found in various places in the cheese factory.
Other violations found by FDA included:
- Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
- Ouleout raw milk cheese from two different lots was analyzed and found to be positive for L. mono.
- Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination, as required.
- Vulto test records show that they conducted environmental sampling only 20 times between July 28, 2014, and Feb. 19, 2017, and that 54 out of 198 swabs taken from various locations throughout the manufacturing facility, including food contact and non-food contact surfaces, tested positive for Listeria.
- Vulto did not conduct an investigation to identify the species of Listeria and failed to recognize its source or point of entry/harborage at the facility.
- Additionally, Vulto did not conduct microbial testing of finished products after finding positive Listeria on food contact surfaces to confirm that the products were not contaminated with the organism detected by the environmental testing program
- Failure to use a procedure for equipment and utensil cleaning and sanitizing that has been shown to provide adequate treatment.
- Vulto repeatedly found Listeria throughout the facility, even after re-cleaning and re-sanitizing.
- Failure to store cleaned and sanitized portable equipment in a location and manner which protects food-contact surfaces from contamination.
- Clean, sanitized wood boards, used to hold RTE cheeses, were stored in the facility’s attic with exposed insulation and other debris.
- Failure to take necessary precautions to protect against contamination of food and food-contact surfaces with microorganisms and foreign substances.
- Wooden boards used for aging are not appropriately cleaned and sanitized. The boards have uneven surfaces which allow for the collection o f moisture and debris and are a potential harborage area for filth and microorganisms. These wooden boards come in direct contact with Vultro aging RTE cheese product and are used for other cheese products.
Failure to construct the plant in such a manner as to prevent drip and condensate from contaminating food and food-contact surfaces, as required. Specifically, condensation was noted dripping from the horizontal stainless steel cheese press bar directly onto the draining table below, on which molded cheese products are placed to drain whey. Dripping condensate in the processing environment can potentially facilitate the movement of pathogens and cause product contamination.
- Failure to maintain physical facilities in repair and in a sanitary condition sufficient to prevent food from becoming adulterated, as required. For example, there was a heavy buildup of rust in multiple locations, including on white painted vertical support bars that hold cheese presses in place. These bars are located directly over a draining table, and rust flakes were on the top surface of the drain table where molds of cheese are set to drain. The rust was also on a painted white metal storage shelf used to store cheese molds, other equipment, and utensils, and on a stainless steel storage shelf used to hold boxes of wrapped finished cheese products. Also, there was a substantial buildup of black mold in multiple locations in the facility, including the cement walls in the manufacturing room and washroom with which cleaning brushes and storage racks come into direct contact. The concrete floors in the manufacturing and cheese aging rooms were cracked and pitted, with moisture accumulated in the cracks and pits.
- Failure to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surface. A fan in the attic, used to dry wood boards used for cheese aging after the boards have been cleaned and sanitized, had dirt and dust debris buildup on its spinning arms and face.
- Failure to take adequate measures to exclude pests from the processing areas and protect against contamination of food by pests. Specifically, a long piece of sticky fly tape, densely populated with dead insects, was observed hanging directly over exposed, uncovered RTE cheeses in defendants’ cheese aging room
The consent decree entered by the court permanently enjoins the defendants from violating the Federal Food, Drug and Cosmetic Act (FDCA). Under the order, the defendants may not manufacture or distribute food unless they comply with specific remedial measures set forth in the decree.
Most of the 18-page consent decree outlines requirements Vulto must follow for the creamery to get back in business. Among those, Vulto must hire a qualified independent expert to develop an effective sanitation control program to adequately control for the risk of L. mono. Before manufacturing or distributing any food, defendants must first receive FDA’s written determination that their manufacturing practices comply with the law.
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