Blue Bell Creameries L.P. was ordered by a federal court to pay $17.25 million in criminal penalties for sending out contaminated products linked to a 2015 listeria outbreak, the U.S. Department of Justice announced Thursday.
“The sentence imposed today sends a clear message to food manufacturers that the Department of Justice will take appropriate actions when contaminated food products endanger consumers,” said Acting Assistant Attorney General Jeffrey Bossert Clark, with the Justice Department’s Civil Division.
The DOJ said Blue Bell pleaded guilty to two misdemeanor counts of distributing adulterated ice cream products in May 2020.
U.S. District Judge Robert Pitman, consistent with the terms of a plea agreement filed in the case, ordered the company to pay the $17.25 million fine. It is the largest-ever criminal penalty following a conviction in a food safety case, according to the department.
The criminal documents filed against the company alleged it distributed ice cream products that were manufactured in unsanitary conditions and contained listeria monocytogenes, a violation of the Food, Drug and Cosmetic Act, according to a news release from the DOJ. Listeria is a dangerous pathogen that can lead to serious illness or death in vulnerable populations such as pregnant women, newborns, the elderly and those with compromised immune systems.
The plea agreement stated that Texas officials had notified Blue Bell in February 2015 after two samples of two ice cream products from the company’s factory in Brenham, Texas, tested positive for listeria.
The company directed its delivery drivers to remove the remaining stock of the products from store shelves but did not recall the products or issue any formal communication to let customers know about the potentially contaminated product, the DOJ said.
State investigators told Blue Bell they found listeria in a third product two weeks after the first tests. The DOJ said the company chose again not to inform its customers, including those in military installations, about the listeria-positive tests.
The U.S. Food and Drug Administration and Centers for Disease Control and Prevention linked the strain of listeria in one of the Blue Bell contaminated products to a strain that made five people sick in Kansas in March 2015, the DOJ said. The department said the patients had listeriosis, a severe illness caused by the ingestion of food contaminated with listeria.
The FDA, CDC and Blue Bell issued public recalls on March 13, 2015. A second recall was announced 10 days later after tests confirmed listeria contamination at a Blue Bell facility in Broken Arrow, Oklahoma.
The plea agreement said FDA inspections in March and April 2015 found sanitation issues at the Brenham and Broken Arrow factories. This included problems with the hot water supply needed to properly clean equipment and deteriorating facility conditions that could lead to unsanitary water dripping into the product mix during the manufacturing process," the DOJ said.
Blue Bell temporarily closed down all of its facilities in late April 2015 to clean and update equipment. The DOJ said the company has “taken significant steps to enhance sanitation processes and enact a program to test products for Listeria prior to shipment” since reopening its facilities in late 2015.