Blue Bell seeks return to normalcy after listeria outbreak

The ice cream maker Blue Bell is asking federal regulators to allow it to drop costly precautions it adopted after a listeria outbreak killed three people last year and resume more conventional food safety measures used throughout the industry, according to records obtained by the Houston Chronicle.

Since the outbreak in April 2015, Blue Bell has destroyed products that showed any possible indications of listeria, even if they ultimately tested free of the bacteria. That has resulted in the unnecessary destruction of hundreds of thousands of cartons of ice cream during the past year and the loss of millions of dollars -- an additional blow to a company crippled by a sweeping recall that forced a shutdown of operations, cut sales in half and led to mass layoffs.

The company has proposed eliminating that precaution and shifting to a testing approach that calls for product destruction only upon confirmation of contamination, according to records obtained through the federal Freedom of Information Act. Records show that privately held Blue Bell has worked for months with an outside laboratory to develop a testing procedure that would meet requirements of the Food and Drug Administration, prevent future outbreaks and help it regain market share and financial stability.

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"Given the extent of the 2015 company-wide recall, it was reasonable for Blue Bell to begin with an extra cautious approach," Joseph Levitt, an attorney for Blue Bell, wrote to the FDA. "But it is now time to transition to the industry norm, having established they have an effective Listeria prevention program in each of its three facilities."

Food safety specialists say Blue Bell's proposal will bring its testing procedures in line with those of other food manufacturers.

Blue Bell, headquartered in Brenham, adopted its current protocol after recalling its ice cream and halting production as a result of contamination linked to 10 listeria cases last spring. It issued another recall this fall after identifying listeria in unopened packages of cookie dough, an ingredient in some Blue Bell flavors, from an outside supplier.

Blue Bell, like other food producers, quickly screens product samples for Listeria monocytogenes, a pathogenic species of the bacteria, and then confirms its presence or absence with more precise tests using lab cultures. The initial screenings can sometimes generate false alarms, or "presumptive positive" results that prove negative after further testing.

It is standard practice within the industry to destroy products only after confirming the presence of the bacteria, which typically takes up to five days after the initial indication. But Blue Bell has been destroying products regardless of confirmation, typically under the supervision of FDA officials.

During the last year, Blue Bell experienced an "unusually high" rate of false alarms that forced it to destroy 31 batches of ice cream that ultimately proved safe, records show. In the span of a week in late April, for example, the company's flagship facility in Brenham recorded false positives for seven batches of ice cream likely worth more than $800,000 in retail value.

Nearly 106,000 half gallons, 32,500 pints and 4,000 three-gallon tubs were loaded in dumpsters and trucked to landfills.

The company's plant in Broken Arrow, Okla., also had a spate of false alarms in the months before and after the rash of incidents in Brenham. Between March and July, at least eight batches triggered false positives. After two false alarms one week in July, employees dumped pallets of Chocolate Chip Cookie Dough and Homemade Vanilla at the landfill as the heat index topped 100 degrees.

The periodic purges have likely cost the company millions of dollars. Euromonitor, an international market research firm, forecasts the company's sales will total $445 million this year, slightly more than half of its 2014 sales.

Blue Bell has proposed and is seeking FDA approval of a new testing regimen. The company declined to answer specific questions about its testing protocols, claiming such information is proprietary.

"We want to prevent the disposal of products that have ultimately tested negative for (listeria), and we feel confident about the reliability of the test methods we submitted to the FDA," a Blue Bell spokesperson said in an email.

Blue Bell began investigating potential causes of the false alarms months ago, records show. In an email to the FDA, Levitt, the company's lawyer, noted the company had considered whether listeria could have at one point been present in an ingredient such as raw cream, but destroyed prior to manufacturing, perhaps during pasteurization, a process that kills microbes in food products.

The company worked simultaneously to evaluate the new testing procedure, demonstrated to reduce the occurrence of false positives. It commissioned a validation study that it shared with the FDA as early as February.

Mansour Samadpour, a food microbiologist and chief executive of Washington-based IEH Laboratories, said Blue Bell is following industry practices and standards. Companies have at their disposal a range of methods to identify listeria and other pathogens, and the FDA leaves it up to them to test and verify the efficacy of their procedures.

"The company gets to choose the method as long as they have validation documents," Samadpour said.

In his letter to the FDA, Levitt noted Blue Bell had already proven itself capable of detecting real threats. In September, two flavors containing cookie dough produced by Aspen Hills, an Iowa-based third-party supplier, showed presumptive positive results for listeria at the Brenham plant, and Blue Bell ultimately traced the pathogen to packages of the cookie dough ingredient.

The contaminated products never left the Brenham plant and Blue Bell recalled flavors made with the same ingredient at its plant in Sylacauga, Ala., even though they had tested clean prior to distribution. Aspen Hills, after reviewing its manufacturing processes, eventually pulled the cookie dough ingredient from the market, leading Blue Bell and at least five other ice cream makers to recall products containing that ingredient.

"In FDA parlance, Blue Bell 'gets it' when it comes to Listeria prevention, and we believe it is appropriate that Blue Bell adjust the criteria for product disposition," Levitt wrote. "Resolving this issue is very important for the company."