We have seen a spate of activity from the Department of Justice recently with regard to investigating food safety activity at a number of different companies. My view is that this is very serious business and is a trend that I don’t expect to slow down any time soon. We are all very familiar with what happened with PCA and the highly public trial and sentencing of a number of individuals from PCA. However, what many may not fully appreciate is that Congress has made it a prohibited act to introduce adulterated food into interstate commerce and also a strict liability offense, meaning that a company or individual that violates the law can face misdemeanor charges whether or not it intended to distribute adulterated food. While keeping that last point in mind, now consider what is going on with whole genome sequencing and the fact that regulators are often undertaking a “swabathon” in food manufacturing facilities. We have seen, on more than one occasion, a situation where a case or two of listeriosis is now being linked back to a food production facility using whole genome sequencing. Are you confused? Well, if so, here is the way it works. When someone gets sick with a bacterial agent like Listeriamonocytogenes or Salmonella and the patient has either blood or stool cultures that isolate the offending pathogen, then that bacterial isolate will be genetically characterized using whole genome sequencing. That genetic information is then entered into a national database that is operated by the CDC. In parallel with this activity, when FDA takes a load of swabs from your plant and finds Listeria monocytogenes or Salmonella in the plant – even if it is zone 3 or 4, then those bacterial isolates from your plant also undergo whole genome sequencing and the data is also entered into the same national data base operated by CDC. OK, now this system has a long memory. So when a human gets sick from Listeria in May 2016 and the bacteria making that person sick matches with a Listeria found in a drain in your facility in 2012, you will likely be in for a call from FDA. If that patient also happens to eat the food you make, then you can be sure you will have a visit. Where I am going with this 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. Interestingly, in FDA’s Regulatory Inspection Manual under section 6.5 “Prosecutions” FDA has made it very clear that prosecutions can have 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.” So, not only is FDA conducting microbiological profiling during food 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. While FDA’s concentrated focus on criminal investigations is relatively new, the process and legality of such prosecution goes back to the Park Doctrine, which is based on a Supreme Court decision of 1975, and provides 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. I first discussed this in the 2011 TAG article The Park Doctrine – A Serious Issue Food Company Executives Need to Know About, when FDA posted a series of recommendations on their web site regarding the use of the Park Doctrine. At that time, I said, “FDA has clearly signaled repeatedly that they are ramping up on enforcement actions and are actively pursuing new avenues for prosecuting individuals involved in food safety violations. The posting of this section about the Park Doctrine underscores that the FDA is serious about criminal prosecutions for food company executives.” And since then, those signals have gained clarity each year. The 28-year prison sentence of PCA’s former president is the most obvious and widely reported of these, but also consider Jensen Farms misdemeanor guilty plea which brought the defendants a sentence of probation, six months of home detention, and a fine; misdemeanor guilty pleas by two Iowa Egg Company executives resulting in prison time, supervised release, and fines; and current criminal investigations of Bluebell, Dole, and others for 2015 outbreaks. As the 2015 sentencing for the 2009 PCA Salmonella outbreak shows, a criminal investigation can linger for years, impacting the company and executives throughout. The standard process begins with FDA’s issuance of a 483 and a warning letter, followed by, as applicable, product seizure, administrate detention, recall, and suspension of registration. Should FDA then decide the matter should be moved on for criminal investigation, the case is referred to the Office of Criminal Investigation, which is responsible for all criminal matters, regardless of their complexity or breadth. This includes criminal search warrants, misdemeanor prosecutions, felony prosecutions, and referrals for criminal investigation. When a criminal investigation is undertaken, the Department of Justice is brought in; and the same set of guidelines is followed that apply to every criminal prosecution: Evaluation of the nature and seriousness of the offense, the deterrent effect of the prosecution, and culpability of the individuals or entities involved. Because Congress made the interstate commerce of an adulterated food a strict liability offense, a company or individual that violates the law can face misdemeanor charges whether or not it intended to distribute adulterated food. So it is at this point that the Park Doctrine comes into play which does not need proof that the corporate official acted with intent or negligence, or even that he or she had any actual knowledge of, or participation in, the offense. Further, and of significant importance – once a person has been convicted of a misdemeanor under the Act, any subsequent violation of the Act is an automatic felony, even, again, without proof that the defendant acted with the intent to defraud or mislead. It is for all these reasons that it is critical that everyone in a food facility understand and follow all food safety practices, and that executives stay tuned in to everything going on in their operations – as they are ultimately responsible for every act that takes place. Additionally, while I caution against simply writing up a food safety plan in order to check off a FSMA box, having that written plan – and implementing it, not only puts you in compliance with the FSMA rule, it can help protect against criminal sanctions by showing that you were taking steps to prevent adulteration. And when assessing your risks, both for FSMA and your own CYA, it is important to include strategic management of operational, regulatory, and reputation risks focused on prevention, with a rapid crisis response plan in place to address each, including: Operational risk: Food safety risks internally and in your supply chain Lack of management commitment. Lack of food safety culture. Failing to adequately document and maintain standards, policies, procedures and expectations. Failing to be proactive. Regulatory Risk: Risk from being out of compliance with regulations Failing to be compliant with all national or local regulatory requirements for food safety. Failing to properly execute on inspectional findings. Failing to adequately manage recall related events. Failing to monitor upcoming regulatory changes that can adversely impact the business. Reputational Risk: Risks related to perceptions that impact your brand Not seeing/preparing for emerging risk. Lack of awareness of media-driven agendas/consumer interests. Mismanaging consumer, customer, and/or employee complaints. Lack of communication with/education of outside groups on your food safety. Despite the scary scenarios I discussed above, it is more important than ever to make every effort to look for food safety problems and take them seriously when you find them. So to give a specific example, set up a solid environmental monitoring program and be sure to follow up thoroughly on positive results when you find them. Failing to do that can land you in a bunch of trouble if at some point your products are linked to an outbreak. FSMA is serious stuff for sure, but this new trend from the Department of Justice and the FDA should be taken very seriously, and every executive in a company involved with food should be aware of this new trend and act accordingly. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
