Blue Bell fined $850K for listeria outbreak

UPDATE July 30, 2016

Texas-based Blue Bell Creamery has reached an agreement with the state health department for penalties related to last year’s listeria outbreak.

Under the agreement health officials have fined Blue Bell $850,000, of which Blue Bell has agreed to pay $175,000 within the next thirty days. The balance of $675,000 could be waived if the company continues to to test and monitor for listeria at its production facility. The ice cream maker must report positive tests for the bacteria found in any finished product, ingredient, or surface within 24 hours of testing for at least 18 months.

Last year’s listeria outbreak sickened ten people and was linked to three deaths.

UPDATE

BRENHAM, Texas - Blue Bell Creameries, the Texas Department of State Health Services and the Oklahoma Department of Agriculture, Food, and Forestry have entered into voluntary agreements outlining a series of steps and actions Blue Bell will take as part of its efforts to bring Blue Bell Ice Cream products back to market.

The voluntary agreements, signed today, detail certain actions Blue Bell will take to help give the public confidence that when Blue Bell products return to market, they are safe. The actions include rigorous facility cleaning and sanitizing, revised testing protocols, revised production policies and procedures designed to prevent future contamination, and upgraded employee training initiatives. Once the company is ready to resume production, the voluntary agreements also call for a trial production period before ice cream is distributed to consumers.

“We are committed to meeting the high standards and expectations of our customers and our regulatory agencies,” said Blue Bell CEO and President Paul Kruse. “State and federal regulatory agencies play an important role in food safety, and we hope that it will be reassuring to our customers that we are working cooperatively with the states of Texas and Oklahoma in taking the necessary steps to bring Blue Bell Ice Cream back to the market.”

Kruse also noted that Blue Bell will continue to work cooperatively and transparently with the U.S. Food and Drug Administration, and has entered into discussions with the State of Alabama Department of Public Health regarding a similar voluntary agreement. Discussions on these voluntary agreements began with the State of Texas and then extended to Oklahoma.

The agreements signed today include provisions specific to addressing Listeria, including:

Conducting root cause analyses to identify its potential or actual sources
Retaining an independent microbiology expert to establish and review controls to prevent the future introduction of Listeria
Notifying the Texas and Oklahoma state agencies promptly of any presumptive positive test result for Listeria monocytogenes found in ingredients or finished product samples, and providing the state agencies full access to all testing
Ensuring that the company’s Pathogen Monitoring Program (PMP) for Listeria in the plant environment outlines how the company will respond to presumptive positive tests for Listeria species
Instituting a “test and hold” program to assure that products are safe before they are shipped or sold.

“These detailed agreements will help guide us back to producing the safe, high-quality products that Blue Bell is known for,” Kruse said. “We appreciate the tremendous public support we have received, and we look forward to working with our regulatory agencies and returning to making ice cream as soon as possible.”

ORIGINAL STORY: June 9, 2015

Brenham, TX – Blue Bell Creameries has provided the U.S. Food and Drug Administration a detailed list of corrective actions that are underway in response to the agency’s inspection reports of Blue Bell’s Brenham, Texas, Broken Arrow, Oklahoma, and Sylacauga, Alabama, ice cream production facilities.

. Blue Bell is taking the FDA observations very seriously, according to CEO and President Paul Kruse, noting that the company’s highest priority is to produce safe, wholesome, high-quality products for consumers to enjoy.

The company is currently in the process of comprehensively reviewing all aspects of operations at the three facilities. Because listeria is ubiquitous in the environment, the company has adopted a broadly focused remediation plan aimed at confronting any possible sources of contamination. This process has led Blue Bell to “reassess everything” about its operations and identify a number of enhancements that will be made, including updated environmental and product testing procedures.

“The company is focusing on ensuring that all aspects of its facilities and production lines are clean and sanitary, and result in a safe product, “ Kruse said.

Blue Bell is taking a consistent approach at all of its facilities, and will be using the same standard operating procedures, testing programs, supplier verification procedures, and overall philosophy at the three plants.

“We hope our efforts demonstrate the seriousness with which we are taking this situation, as well as our commitment to making sure we get this right,” Kruse said. “We are committed to seeing this plan through and to working with the FDA each step of the way. Once Blue Bell, the FDA, and the applicable state regulators agree we are ready to re-introduce products into commerce, we plan to resume production with a phased-in selection of flavors and sizes, expanding only after our revised programs have demonstrated they are capable of ensuring product safety.”