Even as FSMA becomes more real and food facilities are preparing for increased depth of investigations by FDA, it seems that there are other agencies with whom industry needs to be just as concerned and prepared. Namely: the Department of Justice (DOJ). The executives of PCA felt DOJ’s sting in a big way in 2015, and Blue Bell Creameries is now in the department’s sights. Although Blue Bell’s Listeria outbreak is over and the company is moving into its “bonus phase” of re-entry into El Paso, Little Rock, Memphis, and surrounding areas, the ramifications are continuing with a DOJ criminal investigation into whether company management was negligent, or committed other wrongdoing, in the handling of the outbreak and facility conditions. The action is in response to CDC’s PulseNet data of DNA fingerprints matching isolates collected from Blue Bell ice cream samples showing linkage of Listeria infections dating as far back as 2010. What and when did managers and executives know about any contamination? And what did they do once they knew? If DOJ finds anything unseemly, it is unlikely to go easy on them … or any food facility found to be negligent or knowingly producing or distributing unsafe food. In remarks delivered at a conference in December 2015, DOJ Deputy Assistant Attorney General Jonathan Olin stated that a key area of increased focus for the department is food safety. While noting that the overwhelming majority of food in the U.S. is safe, he added, “But practically every week another case comes across my desk detailing shoddy practices by a food manufacturing or processing company.” Because of this and the CDC statistics on foodborne illness and death, Olin said, “Working closely with our partners at the FDA, we will bring civil cases seeking to stop unsafe practices and to require appropriate compliance procedures. And, depending on the facts of each case, we have and will continue to bring criminal prosecutions. … And where the conduct we uncover goes beyond insanitary conditions or other FDCA violations to outright fraud, we will not hesitate to use every available tool to hold accountable those who put their own profits over the safety of the American consumer.” It is a sentiment that is being repeatedly voiced by the department against any aspect of unsafe food—from farm to fork: In response to the PCA sentences, Principal Deputy Assistant Attorney General Benjamin C. Mizer said, “Today’s sentences are a just result. … The Department of Justice will continue to work aggressively with its partners to ensure that the American people are protected from food that is adulterated or misbranded.” In its filing of an injunction against a Vermont dairy farm, Mizer said, “When farms fail to implement and maintain appropriate controls for the administration of antibiotics and other drugs to food-producing animals, they jeopardize public health. The Department of Justice will continue to work with the FDA to try to make sure that consumers are getting safe food.” As such, investigation of a foodborne illness outbreak by the DOJ, following those of FDA and CDC, is an action that is becoming increasingly common – and of increasing risk for the food industry. But in my column of May 14, 2015, I said that I saw some of the Blue Bell 483 observations as being grenades that FDA has lobbed out, and that it will be interesting to see if they have pulled out the pins or not as FSMA continues to roll out. But it now seems that FDA is not the only one launching grenades, making my previous message of even more timely and critical: “Watch out and learn from others’ mistakes.” Watch out: I agree with Olin’s statement that the overwhelming majority of food in the U.S. is safe. I also believe that the overwhelming majority of food providers work to ensure the safety of that food. But I also realize that there are those who knowingly distribute unsafe food; those who try to skirt the line “just a bit” to save money; and those who unknowingly allow unsafe food to go out their door. It is, of course those who knowingly allow such distribution who are of most concern but thankfully that is rare. However, in today’s world, even hedging your bets on something that may be “just a bit” over the line, or even not taking the necessary steps to ensure you do know what is going out your back door can cause the DOJ to show up at your front door. What I have learned from the various DOJ actions is that when individuals get sick and especially if there are deaths, the DOJ is asking the key question of “should that company have known more, and should they have acted differently?” I put PCA in a compartment of its own in this space, but as we have seen with Jensen Farms and ConAgra, DOJ and FDA felt that those firms should have acted differently, should have known better, and should have taken a different approach. As a result, there were consequences that impacted both Jensen Farms and ConAgra. If you knowingly ship contaminated food, then you deserve all that you get. But the key lessons are that you need to track and make the appropriate changes when you know something is creating a potential risk. Because if you don’t, and people get sick, you may well find you are spending time with both the FDA Office of Criminal Investigation and the Department of Justice – neither of which is something anyone in the food industry wants to do. Not looking for problems is no excuse either. Remember, as so strongly promoted in FSMA, today’s food safety is all about prevention. And not implementing all preventive controls needed to ensure safe food will put you at risk—you, personally, as well as your business as a whole. 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
