Blue Bell latest in food safety crackdown

WASHINGTON, Dec. 30, 2015 - The Justice Department has reportedly launched a criminal investigation of Blue Bell Creameries over a deadly listeria outbreak, the latest example of the Obama administration’s effort to turn up the heat on producers and processors over food safety failures.

CBS News reports that investigators are looking into Blue Bell production practices that led to the sickening of at least 10 people – four in Kansas, three in Texas, two from Arizona and one from Oklahoma. FDA inspection reports found that Blue Bell facilities were not being kept clean before the outbreak occurred.

The Justice Department would not comment on whether or not it is conducting an investigation. “As a matter of policy, the Justice Department generally neither confirms nor denies whether a matter is under investigation,” DOJ said.

Blue Bell did not return a call to its media department. The company has been gradually ramping up its operations and expects its ice cream to be available in 15 states by Jan. 25.

It also has said it instituted a number of practices to prevent future outbreaks, such as hiring a microbiologist to examine its production process and implementing a “test and hold” procedure, “where production runs will be tested and held until results are received before being distributed to market.”

A Justice Department investigation wouldn’t necessarily result in criminal charges, but the federal officials have put producers and processors on notice that they could be prosecuted in some cases.

“You can get busted for selling bad ice cream,” said Seattle-based food safety lawyer Bill Marler, who has represented victims in numerous major outbreaks.

In September, peanut company executive Stewart Parnell was sentenced to 28 years in prison in connection with a 2009 salmonella outbreak linked to the Peanut Corporation of America.  His brother, Michael, was given a 20-year term.

Also this year, Austin “Jack” DeCoster and his son, Peter DeCoster, received three-month jail sentences, which they are appealing, after being criminally charged when their Iowa egg operation was tied to a salmonella outbreak that sickened nearly 2,000 people.

In 2014, brothers Eric and Ryan Jensen of Jensen Farms in Colorado received five years’ probation and were ordered to pay $150,000 each in restitution to the victims of a 2012 listeria outbreak caused by their cantaloupes. They had pled guilty the year before.

And earlier this year, ConAgra Grocery Products LLC pled guilty and agreed to pay $11.2 million in penalties following a 2006-7 nationwide outbreak of salmonellosis, or salmonella poisoning, linked to their peanut butter.

Bruce Silverglade, a food industry attorney with OFW Law, said in an email that company executives “should exercise additional caution and beef up Quality Assurance staff and supplier controls.”

Using FDA-accredited third-party auditors will help officials defend themselves during an FDA enforcement action, but he cautioned that the new rules being implemented under the Food Safety Modernization Act (FSMA) will “present gray areas that call for legal counsel beyond review by regulatory affairs professionals.”

Marler said prosecutions are still “incredibly rare” but that it’s difficult to tell when the Justice Department will decide to prosecute. “There has yet to be a rhyme or reason or a real clear sense of when they’re going to prosecute or not,” Marler said.

“Why prosecute Blue Bell and not Townsend Farms?” he asked. In 2013, 165 people became ill with Hepatitis A linked to pomegranate seed pods, or arils, contained in that Oregon company’s organic antioxidant blend.

Marler said the FDA inspection reports on the Blue Bell facilities were “some of the worst” he has seen. “They knew listeria was in their facility.”

At Blue Bell’s Broken Arrow, Okla., facility, FDA inspectors found a “failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.” The company’s Brenham, Texas, plant “is not constructed in such a manner as to prevent condensate from contaminating food and food-contact surfaces,” FDA said in its report. And at the Sylacauga, Ala., plant, FDA found a “failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives.”

Marler said the issue of criminal prosecution has come up frequently in conversations he has had with food industry officials at recent conferences.

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One aspect of the Food, Drug and Cosmetic Act that is especially difficult for growers and processors to handle is that you can be found guilty even if you did not know about the contamination, according to Marler.

“A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct,” he said in a blog post. “Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.”

Small-scale farms are watching with some concern to see how the FDA handles authority under the Food Safety Modernization Act, which mandated preventive controls for processors and national standards for growing and handling produce.

“The new FSMA regulations push liability further down the food chain all the way to the farm.  Most food safety problems originate in processing and distribution, but even then farms can be impacted if they lose market access due to fear rather than reality,” said Ferd Hoefner of the National Sustainable Agriculture Coalition.

“Hopefully a farmer education and training approach will prevail as the predominant focus, backstopped by inspection and enforcement activities strictly targeted to known, high-risk activities.  If so, we believe it will get off to a good start.  If not, I think we can count a good deal of controversy in the implementation phase of FSMA.”

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