Tag Archives: Department of Justice

Randy Fields, Repositrak
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Update: Non-FSMA Food Safety Litigation

By Randy Fields
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Randy Fields, Repositrak

The keynote panel at the 2017 Food Safety Summit in May had, as any food safety professional would expect, a focus on how companies are coping with FSMA and the increased scrutiny they may face. There was unanimous belief on the panel that enforcement is coming and all trading partners need to be prepared, but there was also a look beyond FSMA adoption to what will come next.

First, though, where do we stand with FSMA-related litigation?

Shawn Stevens, one of the leading food industry lawyers, told attendees that it’s important for all retailers, wholesalers, suppliers and affiliates to understand that FDA was commanded by Congress to stop foodborne illness and the impact it has on Americans, plain and simple. His advice is for food pros to learn all aspects of FSMA and do it quickly, saying the goal now is to avoid making the operational mistakes that may result in criminal exposure for the company and its executive leadership team.

Going forward, the industry will not only have to comply with FSMA, but it will also need to address recalls, risk mitigation and other complex food safety issues not directly related to FSMA. Foodborne illness outbreaks will still cause legal claims that can be compounded by personal injury suits and potentially impact a retailer’s reputation negatively. Also, there are trends in organic foods, GMOs, gluten-free items and more that will impact the retailer, supplier and ultimately may result in more litigation.

Jeffrey Steger, assistant director of the Consumer Division at the U.S. Department of Justice (DOJ), reported that companies shouldn’t expect a waning of the federal government’s support of non-FSMA enforcement actions. The DOJ gets involved in cases where there is significant harm to consumers, where food company executives had prior knowledge, and where legal action will protect the integrity of the regulatory system and prevent future harm. It has pursued many high-profile food industry prosecutions to date and he believes this trend will continue.

The importance of the FSMA regulations and the responsibilities placed on the food industry shouldn’t be understated in the context of food-related litigation. But there are other new developments in the marketplace and the extended supply chain that are impacting retailers like transparency in packaging, labeling of social responsibility programs, the move toward clean labels and facility auditing requirements.

Recent research by the Food Marketing Institute indicates retailers and suppliers that connect with shoppers in support of food safety are well positioned to build shopper trust and loyalty. The converse must also be true—companies that have their reputation dragged down due to involvement in food safety litigation will surely be poorly positioned to build shopper trust and loyalty.

Retailers and suppliers need to address all food safety-related issues or risk becoming defendants in a lawsuit or further government regulation. To accomplish this goal and, more importantly, to keep their customers safe, food companies need to nurture an enterprise-wide food safety culture that extends from the executive suite to store personnel –all retail employees must be responsible for food safety. Only then will customers recognize the company as being committed to food safety, and only then will the company get ahead of any potential food safety-related litigation.

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Seeking Deterrent Effect, DOJ Targets Cases that Have Big Influence

By Maria Fontanazza
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As the Department of Justice (DOJ) continues to prioritize prosecution against food companies that have been involved in recalls and foodborne illnesses, many often wonder how exactly the department decides which companies it will pursue and why. The most notorious recent example is the case against the Peanut Corporation of America (PCA) in which the sentencing of the company’s executives was said to have set a precedent for the industry. One of the reasons the DOJ went after PCA was due to its widespread distribution of food and the fact that the illnesses and deaths were all over the country, according to Michael Blume, director of the consumer protection branch of the DOJ.

“Did any of you hear about [PCA] before the outbreak?” Blume asked the audience at the GMA Science Forum last week. “Consumers have very little ability to protect themselves from foodborne illness. PCA was in all kinds of brands—crackers, Kelloggs, [etc]. For those reasons, we were much more concerned about preventing these kinds of outbreaks and what could the DOJ do about it.”

When assessing contenders for criminal prosecution, there are several common factors that encourages the DOJ to dig deeper:

  • The amount of harm. Has the sale of contaminated food has led to a great deal of illnesses or deaths?
  • Has the company had problems in the past? If it is a first time occurrence, the DOJ is less likely to pursue a case, but if there is a history, “we’re going to look harder,” said Blume. For example, if a government agency or another party has identified a problem, and then the FDA also sees the problem and issues a 483. Then five years later, the company still has not fixed the problem.
  • Similarly, if the DOJ sees that the company has identified internal problems and has chosen not to fix them, and as a consequence, these actions lead to the sale of contaminated food.
  • Where does the company sit in the market? “We can’t [pursue] every case, we have to think about what case will be most impactful,” said Blume. “What case will signal to the rest of industry that there are things they need to think about? If it is a company that people think have a good reputation, etc—to give a signal to industry—there are things that even the very best in industry can run afoul.”
  • If there’s evidence that the company has misled any party. This doesn’t apply to a government body only—it could also be the company’s vendors.
  • The general culture. Although this concept is intangible, the DOJ considers a company’s reputation in the industry and the relationship it has with regulators. Are they trying to fix issues and maintain compliance? That will make a difference and will be weighed in the company’s favor versus companies that choose to ignore problems.

“The DOJ thinks very hard about charging individuals. If there’s a criminal investigation targeting a company, you have to be concerned about who acted within the company and what their role was.” ­– Michael Blume, DOJ

Of course, food companies would like to avoid the heavy hand of the DOJ and for that, Doug Fellman, partner at Hogan Lovells US, LLP, offered several points of advice:

  • Be on guard for red flags that suggest a compliance-related environment in which the company is at risk for having problems. If employees are raising concerns at the facility or about the manufacturing process, don’t let people write those individuals off.
  • Be careful about how any decisions will look in hindsight. Stop on a real-time basis and look at how it will appear in retrospect.
  • If in a recall situation, decisions must be made quickly. Be careful that any decision making won’t to come back and bite the company when someone looks at it with the benefit of time.
  • Always be truthful and candid with the regulators.
  • Ask yourself whether you really know the conditions at the facility. Do people have visibility to what’s happening there?
  • Beware of emails. “Emails form the basis of almost every case I have,” cautioned Fellman.

Should the DOJ show up at your facility, it’s important to be polite and act professional towards agents. Although this may seem obvious, whether or not the agents immediately encounter pushback makes a difference, advised Blume. That said, it’s important to have protocols in place in the event that the DOJ shows up either at a company facility or even at an employee’s doorstep. “We get great evidence from a knock at someone’s door who doesn’t know what to say or when we do an inspection and people don’t know what to do,” said Blume. It’s prudent to discuss in advance when to seek the advice of a lawyer, because the more prepared a company is in handling such an issue, the less likely it is to make incriminating statements.

ConAgra Subsidiary Slapped with Largest Criminal Fine Ever in Food Safety Case

By Food Safety Tech Staff
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Earlier this week ConAgra Grocery Products, LLC, a subsidiary of ConAgra Foods, Inc., was sentenced to pay $11.2 million after pleading guilty to a criminal misdemeanor charge related to shipping peanut butter contaminated with Salmonella. The $8 million criminal fine and forfeiture of $3.2 million in assets is the largest fine ever paid in a food safety case, according to the Department of Justice.

“This case demonstrates companies – both large and small – must be vigilant about food safety,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division in a release.  “We rely every day on food processors and handlers to meet the high standards required to keep our food free of harmful contamination.”

Stephen Ostroff, 2016 Food Safety Consortium
WATCH THE VIDEO: Stephen Ostroff, M.D., FDA deputy commissioner for foods and veterinary medicine discussed the agency’s take on criminal liability at the 2016 Food Safety Consortium

ConAgra admitted that it introduced contaminated Peter Pan and private label peanut butter into interstate commerce (produced and shipped from the company’s facility in Sylvester, Georgia) during an outbreak of Salmonellosis in 2006. The company also admitted that it had been previously aware of the risk of Salmonella contamination in peanut butter dating back to 2004. Among the culprits of the contamination (as identified by company employees) were an old peanut roaster that did not uniformly heat the raw peanuts, a sugar silo damaged by a storm, and a leaky roof that permitted moisture to enter the facility, followed by airflow that may have pushed the contamination throughout the plant.

The company tried to address some of the issues, but the DOJ stated that ConAgra did not fully correct the situation until after the 2006–2007 outbreak.  “While ConAgra did take corrective action eventually, by failing to timely recognize and rectify the problem of salmonella contamination, this company damaged the health of both public consumers and of the agricultural industry overall.  I commend my staff, that of the Consumer Protection Branch of the Civil Division of the U.S. Department of Justice, and the investigators of the FDA, for the excellent work by all in bringing this incident to this conclusion and I hope that it will serve as a reminder to others in the industry of the high cost of failing to protect the public that relies on them to properly meet this responsibility.”

Watch Out, DOJ and FDA Prioritizing Prosecution

DOJ Launches Criminal Investigation into Dole

By Food Safety Tech Staff
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Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREOn Friday the news broke that the U.S. Department of Justice (DOJ) was investigating Dole Food Co. over the Listeria outbreak involving packaged salad. The deadly outbreak was linked to salad produced at Dole’s Springfield, Ohio facility. Although the DOJ has not yet commented on the criminal investigation, The Wall Street Journal reports that Dole reported positive Listeria samples at its facility as early as July 2014.

In January 2016, Dole voluntarily recalled all salad mixes produced at the Springfield plant, by which point 33 people in the United States and Canada had fallen ill with Listeria and four had died. The CDC reported on March 31 that the outbreak appeared to be over and Dole restarted production at the Springfield facility in April.

In a press release on the company’s website, Dole stated that the issues FDA reported at its Springfield facility have been corrected. “We have been working in collaboration with the FDA and other authorities to implement ongoing improved testing, sanitation and procedure enhancements, which have resulted in the recent reopening of our Springfield salad plant.” It also acknowledged that it had been contacted by the DOJ related to an investigation and will be cooperating with the department.

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Watch Out, DOJ and FDA Prioritizing Prosecution

By Food Safety Tech Staff
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In remarks made at the Consumer Federation of America’s annual food policy conference this week, Benjamin C. Mizer, principal deputy assistant attorney general, stated that the federal government has made consumer safety a top priority. With this announcement comes an announced intention on the part of the U.S. Department of Justice (DOJ) to use “various enforcement tools that we have at our disposal,” and maintain a stronger partnership with FDA to go after companies that “introduce adulterated foods into interstate commerce”.

“In deciding whether to use our civil or our criminal enforcement tools, the Justice Department follows the same set of guidelines that apply to every criminal prosecution,” said Mizer. “Among other things, prosecutors evaluate the nature and seriousness of the offense, the deterrent effect of the prosecution and the culpability of the individuals or entities involved.” Criminal charges brought against a food company can be either misdemeanor or felony, and Mizer emphasized that misdemeanor violations can still result in “serious penalties”. He cited a case in which the owner and CEO of an egg production company in Iowa pled guilty to a misdemeanor and received three months in jail and one year supervised release, and was slapped with a $100,000 fine.

“In some cases, the facts are so egregious that it is appropriate for the Justice Department to bring the full force of the law to bear,” stated Mizer. “When we can show an intent to defraud or to mislead consumers or the FDA, a defendant can face felony charges.” To illustrate this scenario, Mizer referred to the landmark case against the Peanut Corporation of America, which is perhaps the most commonly referenced case in recent months, as many in the industry have voiced their opinion that it has set a precedent as to how the government will handle such situations moving forward.

Federal Government Takes Regulatory and Criminal Offensive Against Food Industry

 

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Department of Justice Reportedly Investigating Blue Bell Creameries Over Listeria Outbreak

By Maria Fontanazza
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Several news outlets have reported that the U.S. Department of Justice (DOJ) is investigating Blue Bell Creameries following the Listeria outbreak that resulted in three deaths in Kansas and 10 illnesses in Arizona, Kansas, Oklahoma and Texas between January 2010 and January 2015.

According to The Wall Street Journal, the DOJ is mainly interested in the involvement of company executives—did they know about the Listeria contamination? If so, what did they do about it?

Last April Blue Bell recalled all of its products over concerns of Listeria contamination and shut down the production line where the products were manufactured.

Blue Bell started a limited-release of its ice cream products last August. The company has not yet issued a response to the reports about the DOJ investigation, but last week it announced that it would begin a “bonus phase” of product re-entry in El Paso, Texas, Little Rock, Arkansas, and Memphis, Tennessee. This is scheduled to be followed by phase five of market re-entry in parts of Tennessee, Alabama, Georgia, Kentucky, North Carolina, South Carolina, and Virginia the week of January 18, and then shipment into all of Florida, southern Georgia and southern South Carolina the week of January 25.

The company stated in a press release that after phase five is completed, all of Blue Bell’s furloughed employees will have returned to work.

Following the landmark sentencing of Peanut Corporation of America executives last fall, industry will be watching the outcome of the investigation very closely.