It doesn’t take a great deal of reading or research to see that there has been a marked rise in Department of Justice (DOJ) activity in the food industry over the last few years. In fact, the DOJ’s Principal Deputy Assistant Attorney General Benjamin Mizer spoke at a food policy conference in April on that very topic, discussing DOJ’s role in ensuring the safety of the food supply, and the enforcement tools it has to fulfill that role.
As Mizer stated, “One of the government’s highest obligations is to protect citizens when they cannot protect themselves.” Because consumers have to rely on the companies who manufacture and distribute food to ensure that the food they buy is safe, the government sees food safety as an area in which consumers cannot always protect themselves, so it has an obligation to assist in providing that protection.
Such protection is also the very foundation of the Food Safety Modernization Act (FSMA) and its risk-based preventive controls, and DOJ, FDA, and USDA have been acting on that obligation not only in increasing frequency, but in increasingly severe ways, i.e., the 20+-year prison sentences of the PCA executives. And, as I wrote in a recent newsletter (How Serious is the Department of Justice?) which I will recap a bit in this article, my view is that this is very serious business, and it is a trend that I don’t expect to slow down any time soon.
“Back up a minute,” you may be thinking. “What about all the work we’ve done for FSMA compliance? Won’t that get us off the DOJ hook?”
WILL FSMA PROTECT YOU? Yes. And no. If you are truly and completely following FSMA, including its inference to build a food safety culture into your organization which is followed from the top down, you will have gone a long way in the prevention of the contamination or adulteration of your product which will, as a result, go a long way in the prevention of an investigation by FDA or DOJ. (Former FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor specifically discussed the relationship between FSMA and a food safety culture in FDA: Culture Is a Preventive Control, QA May/June 2015.)
But we all know that no one and nothing is perfect; no one expects that FSMA will eliminate all contamination and foodborne illness. But what you may not know or fully appreciate is that Congress made it a prohibited act to introduce adulterated food into interstate commerce; and it is a strict liability offense, meaning that a company or individual who violates the law can face misdemeanor charges – whether or not it intended to distribute adulterated food.
Additionally, in FDA’s Regulatory Inspection Manual under section 6.5 “Prosecutions,” FDA made it very clear that it sees prosecutions as beneficial to food safety as having a deterrent effect. Specifically, the document states: “Misdemeanor prosecutions, particularly those against responsible corporate officials, can have a strong deterrent effect on the defendants and other regulated entities.” It’s essentially the same tactic that is taken by parents around the world. Threats are only as good as their corresponding action: if a rule is broken and the guilty child faces no repercussions, every other sibling will see the rule as nonbinding. But if punishment is meted out to a degree that befits each violation, it not only impacts the reprimanded child, but also each sibling who sees that the parent is serious.
Though the prosecution meted out by FDA is, of course, much more serious, it follows the same philosophy: Let the corporate executives see that we are serious; let them see that we will prosecute; and it will put the fear into them. As I heard one father say many times, “My children will either respect me or fear me.” If the only way a child/some food corporations will follow the rules is the fear of punishment/prosecution, then so be it.
The analogy can be taken even a step further: Recall a time that you were with a younger child (whether it was a sibling; a niece, nephew, a child you were babysitting, etc.) whose actions caused harm – broke an item, hurt another child, etc. Wasn’t the first question, “Why weren’t you watching him/her better?” or “You should have known, you were in charge!” or simply “Who’s older?” (i.e., “Who’s the boss?”) In the same way, any process that takes place in the food facility; any harm that is caused by a person or action; any contamination that began anywhere along the food chain will be considered to be the responsibility of the corporate executives, because as executives, it is their job to know, to ensure practices are in place and are being followed. They are “in charge.”
AN INCREASED FOCUS. And FDA is checking. With the advanced detection of whole genome sequencing; its “long memory” (ability to match a bacteria found in a facility today with one found four years ago – or longer); its linkage in CDC’s national database; and the FDA inspectors’ current propensity to undertake a “swabathon” in food manufacturing facilities – we are beginning to see more and more situations where a case or two of listeriosis is being linked back to a food production facility. What all this means is that it is much easier today to link a sick human with a suspect food and food plant. Thus, the odds that you will be found to have put adulterated food into commerce – even if totally without intent – continue to rise.
Further, if FDA then finds that you have had positive hits with Listeria but not taken appropriate corrective actions and root cause analysis, you can end up with the DOJ coming to visit. So, not only is FDA conducting microbiological profiling during facility inspections and testing food at retail, it is acting on its right to initiate criminal investigations against food companies and their executives who distribute food products that have the potential to cause human illness – even when the executives had no direct knowledge of the potential.
Although there is certainly an increase in criminal investigations and DOJ prosecutions, it is not a new tool for the agency. Rather, it dates back to a 1975 Supreme Court decision from which the Park Doctrine established that a responsible corporate official can be held liable for a first-time misdemeanor (and possible subsequent felony) under the FD&C Act without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense.
You, obviously, will have noticed by now that I have repeatedly stated that one can be prosecuted and held liable even without knowledge or intent. In fact, it has been stated so often, you may be wondering if I actually reread my own columns before submitting them. But understand that my repetition is quite purposeful. There is an ancient legal principle that states, “Ignorance of the law is no excuse.” That is, even if you do not know that something is against the law, you can still be punished for doing it. The same holds true here – even if you don’t know that something occurred, or could occur, you can still be punished for it.
To see that this is true, simply consider Jensen Farms – which contended that it had relied on a Superior audit rating and didn’t know their operation was flawed, yet they were sentenced to probation, home detention, and a fine. You may also want to keep an eye on the current criminal investigations of Bluebell, Dole, and others for 2015 outbreaks.
DOJ “TOOLS.” Back in the first paragraph of this article I noted that Mizer’s statement included the fact that DOJ is not only focused on ensuring the safety of the food supply, it also has the enforcement tools to do so. What exactly are these “tools”? What sorts of punishment might a corporate executive (or others) face?
First, it is important to understand that DOJ relies on FDA, USDA, and CDC for “their technical expertise, their investigative support and their deep knowledge of the industries they regulate as keys to building cases,” and that the FD&C provides DOJ with both criminal and civil authorities, with that decision based on the evidence and applicability. Following is some of the detail Mizer provided about these tools:
- Civil Authority. The civil authority is primarily designed to prevent the distribution of adulterated food, such as asking a court to order the seizure of potentially unsafe products or to temporarily prevent a facility from operating until sanitary conditions are established. In these cases, which are often resolved through negotiated agreement, the goal is to require that the company institute new health and safety procedures and that it not be able to distribute food until the government can verify that it has taken all steps necessary to prevent a recurrence. Civil enforcement is often used in cases of unsanitary conditions and has also been used for those involving the administration of drugs/antibiotics to animals intended for human consumption.
- Criminal Prosecution. When DOJ decides that criminal prosecution is warranted, based on such things as the nature and seriousness of the offense, the deterrent effect of the prosecution, and the culpability of the individuals or entities involved, it must then decide whether to bring misdemeanor or felony charges. Even if DOJ elects to charge a violation as a misdemeanor, it can still bring serious penalties, such as the misdemeanor sentences of the Iowa egg farm owner and CEO of three months in prison, one year of supervised release, and a $100,000 fine. Felony charges will be brought when the facts become egregious enough to warrant that, such as when DOJ can show an intent to defraud or to mislead consumers or the FDA.
Civil cases make up the majority of the food safety actions brought by DOJ. “But,” Mizer said, “sometimes it’s important that we hold criminally accountable those individuals and entities that place consumers at risk by putting unsafe food on our table and in our lunchboxes. That way we make clear to people in the industry that they have a responsibility to protect the safety of the public.”
What makes these prosecutions of further consequence is that, under the Park Doctrine, once a person has been convicted of a misdemeanor under FD&C, any subsequent violation is an automatic felony, even, again, without proof that the defendant acted with the intent to defraud or mislead.
So, to jump back to the question: Will FSMA get you off the DOJ’s hook? Yes and no. But full implementation of FSMA and the involvement of everyone in the organization will certainly help in prevention, and in providing at least some defense if a contamination does occur. FSMA is serious stuff for sure, but this new trend from DOJ and FDA should be taken very seriously, and every executive in a company involved with food should be aware of the trend and act accordingly.
David Acheson is Founder and CEO, The Acheson Group.
