What authority does the FDA have in the wake of a contaminated food-related outbreak?
The following article is posted with permission from the Food Safety News.
More than a year after the deadly Listeria outbreak that stemmed from Jensen Farms’ cantaloupes was first detected, criminal charges have yet to be filed against the company, but the Food and Drug Administration’s website says its outbreak investigation is still open.
FDA’s report was last updated on January 8, 2012 with information provided by the Centers for Disease Control in its final update, which reported a total of 147 illnesses in 28 states, 33 deaths and one miscarriage linked to the outbreak.
Since FDA has yet to close the case – or notify the public of any further actions regarding the outbreak – will Jensen’s face criminal prosecution sometime in the future?
The U.S. Attorney’s office in Denver would not confirm nor deny the existence of any investigation into the Jensen Farms case when contacted by Food Safety News.
The lack of criminal charges in the wake of a widespread outbreak like this one is not unprecedented. The 2008-2009 Salmonella outbreak linked to peanut products from the Peanut Corporation of America that sickened more than 700 and killed nine has still not resulted in criminal charges, despite the fact that the company’s CEO, Stuart Parnell, evidently knew that some products were contaminated before they were shipped out, and an FDA investigation revealed numerous sanitation violations at the company’s production facility.
“Based on my review of the evidence, there should be a criminal prosecution here,” said Senator Amy Klobuchar (D – MN), a former prosecutor, when the criminal probe was announced.
“These are two crystal clear cases where criminal prosecution should have been at least considered, and you have no idea why it was not,” said Peter Barton Hutt, senior counsel with Covington & Burling and former Chief Counsel at the FDA from 1971-’75, speaking about the 2011 Listeria cantaloupe and the 2008-09 Salmonella peanut butter outbreaks.
“FDA is a true black box,” Hutt said in an interview with Food Safety News. “There is no way that you can penetrate the agency’s decision process while they are under review. The Freedom of Information Act is clear in that enforcement documents are not required to be released to the public, so the public sits in the dark.”
While FDA and DOJ policy prevents each department from commenting about ongoing investigations, Jeff Almer, whose mother died as a result of a Salmonella infection contracted from Peanut Corporation of America’s peanut butter, told Food Safety News that he has been in contact with federal investigators.
“I know there’s something going on,” Almer said. “I’ve had a few exchanges, via email, via phone and actually meeting in person with them. And I know other people involved in the case who were interviewed by them this summer.”
While reporting dozens of drug-related criminal convictions on its website, the FDA reports few food-related cases and there are no reports of convictions as a result of foodborne illness cases in 2012.
The last food-related criminal conviction reported by FDA occurred in May of this year, and stemmed from the misbranding of Chinese-grown produce as being from Costa Rica. Pure Nature Organics, LLC, was sentenced to three years of probation, a $50,000 fine and the required implementation of a new food distribution compliance plan.
The 2010 Salmonella Enteriditis outbreak that led to more than half-a-billion recalled eggs and is blamed for 1,939 illnesses is another one that has yet to produce any criminal charges. In May, the Bangor Daily News reported that executives with Quality Egg were targets of a federal criminal investigation.
Peter Deegan, a U.S. Attorney stationed in Iowa, also could neither confirm nor deny the existence of any criminal investigation to Food Safety News.
Other than these few investigational probes, there is little evidence of any prosecution by FDA or DOJ as a means of encouraging food producers to keep their operations clean. “In effect, FDA is saying even if you kill people, even if people die because of your failure to comply with the law, we are not going to prosecute,” Hutt said. “You could turn that around overnight with three or four criminal enforcement actions.”
Even though FDA has yet to prosecute these food producers and distributors, the agency’s criminal authority is among the strongest of the federal government when it comes to charging those who violate U.S. food laws.
The first federal food and drug law was passed in 1906. It has been amended regularly since then, but two food production practices have remained illegal since its inception: 1) The misbranding of food, and 2) The adulteration of food.
What makes FDA’s statutory power here different than the government’s authority in most criminal law is the standard that allows the agency to find someone guilty of misbranding or adulteration. Whereas most crimes require proof of intent, or even proof of a specific bad act by the defendant, the Food, Drug and Cosmetic Act (FDCA) does not.
“It is unique in American legal history,” Hutt says. “The federal meat inspection statute is the only other statute that I know of that can find liability without fault.”
With that in mind, the FDCA prohibits, among other things, the following actions relating to food:
1) The introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded
2) The adulteration or misbranding of any food in interstate commerce
3) The receipt in interstate commerce of any food that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
“Everyone was put on notice,” Hutt said. “If you’re not prepared to comply with the FDCA, you ought to get into some other business. This is such an important area. You can’t live without food, and therefore there are special rules.”
Supreme Court decisions have backed that up and added language to the regulatory structure.
In 1943, the Supreme Court upheld the unique criminal standard under the FDCA in U.S. v. Dotterweich, which says that even if a person within a corporation is not intentionally acting fraudulently, they can be held criminally culpable under the act for having a responsible relationship to the distribution of misbranded or adulterated food.
The Supreme Court upheld that standard in 1975, during Hutt’s tenure at the FDA, in U.S. v. Park, wherein the president of Acme Markets, Inc. was personally found guilty of violating the FDCA after Acme food storage facilities were determined to be accessible to rodents, leading to the adulteration of food before it was sold in Acme stores.
Writing for the Court, Justice Burger held the following:
Thus Dotterweich and the cases which have followed reveal that in providing sanctions which reach and touch the individuals who execute the corporate mission – and this is by no means necessarily confined to a single corporate agent or employee – the [FDCA] imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur. The requirements of foresight and vigilance imposed on responsible corporate agents are beyond question demanding, and perhaps onerous, but they are no more stringent than the public has a right to expect of those who voluntarily assume positions of authority in business enterprises whose services and products affect the health and well-being of the public that supports them.
Both Dotterweich and Park are still good law today. Hutt said these cases had a huge impact on the food industry.
“The Park decision made it clear to everyone that the CEO couldn’t create the position of the Vice President of Going to Jail,” Hutt said. “There’s no way the CEO can get off the hook under the Dotterweich and Park decisions. Quality control people would stop me on the street and say that was the single most important Supreme Court decision in American history. It allowed the quality control people to say to the CEOs that this is your responsibility and you can be found liable.”
If the FDA has the broad authority to prosecute executives under the FDCA, why are these widely-publicized cases coming and going without any criminal penalties being levied? The public does not have access to the answer to this question.
After conducting criminal investigations, the FDA refers its cases to the Department of Justice (DOJ). The FDA may have already transferred these cases to the DOJ, but until either department releases information to the public, consumers will be out of the loop.
“First, the [Peanut Incorporation of American] investigation should’ve been over long before now” Hutt said. “Second, the FDA should’ve released their information. For all we know, this could be sitting at the Department of Justice. I don’t know who to blame, the FDA, the DOJ, or nobody.”
Almer is hopeful that the length of the investigation is due to the importance of the case.
“My understanding of what is going on is this is definitely unique,” Almer said. “They want to cross all their t’s and dot their i’s. They want to get it right.
“My guess is people will be surprised by what they find. It might be more far-reaching than people are expecting.”
But waiting can be the hardest part for those with a personal interest in the outcome of any criminal investigation.
“I wish somebody like 60 Minutes would just explain this story to people out there,” Almer said. “People just assume the guy went to jail. Nobody follows it after the big story breaks, and here it is four years later and we don’t know anything.”