I spend a lot of time helping food companies eliminate food safety risks in their operations that can make people sick. It’s a tough job. That’s because many of the foods we eat are really quite dangerous. They are also difficult to keep safe. Within just the past 12 months, a broad array of foods we typically regard as safe, ranging from caramel apples to ice cream, have been unexpectedly recalled because they contained Listeria monocytogenes. Indeed, these two products sickened dozens of people and killed nearly 10 of them. What is equally alarming is these products join an already diverse list of common foods that have caused outbreaks, including milk, spinach, sprouts, peanut butter, cheese, cantaloupes, and raw cookie dough. And the broad range of pathogens causing these outbreaks are just as assorted. In addition to the risks associated with Listeria, Salmonella, E. coli O157:H7 and other emerging pathogens continue to find their way into food processing facilities, finished food products and customer’s homes. So, is there a warning to the food industry built into these food safety headlines? The answer is yes. And no company, no matter how sophisticated or experienced in pathogen control, is immune. Each year, the Centers for Disease Control and Prevention (CDC) estimates that nearly 48 million people will become sick from a foodborne illness, nearly 128,000 will be hospitalized, and nearly 3,000 will die. This past year alone, U.S. food companies recalled approximately 500 separate FSIS- and FDA-regulated food products for food safety, quality and labeling issues. The large number of consumer illnesses and food product recalls is surprising and demonstrates that all food companies need to start being more selective about the ingredients they source to produce their finished products. Why is there so much risk associated with the harvesting and production of food? The answer is simple. Many of the foods we eat (or the ingredients we use to make the foods we eat) are grown and harvested in environments where they are susceptible to contamination. Fruits, vegetables and other products, such as spices, can easily become contaminated with Listeria, Salmonella or E. coli in the fields where they are grown. In some cases, these products can become contaminated in transit, or in the manufacturing facilities where they are processed. If industry is not extremely careful about properly sourcing and then appropriately handling fruits, vegetables and similar products, it is extremely easy to put consumers at risk. A recent outbreak caused by cantaloupe carrying Listeria is a perfect example, where 1,476 people became sick and 33 died. But raw produce and spices are not the only concern. It is common for animals (and, by extension, raw meats) to become infected with deadly bacteria as well. Ground beef, for instance, is also known in some cases to carry pathogens such as E. coli, Salmonella and Listeria. And these pathogens can be very aggressive. A person need only ingest about 10 E. coli cells to become sick. That is an alarming number considering that nearly 250,000 cells can fit on the head of a paper clip. And, although these pathogens are killed if the food is heated to 165 degrees F, current estimates suggest that as many as 28 percent of U.S. consumers enjoy eating their beef raw or undercooked. As noted, without adequate controls, the environment in processing facilities and grocery stores where ready-to-eat food is prepared can also be quite dangerous. Although many food products are washed or cooked to eliminate pathogens before final preparation or sale, they can become contaminated with harmful bacteria during processing or prior to sale in the manufacturing or deli environment. Once Listeria is introduced into the processing environment, it can spread and unknowingly contaminate food products such as fruits, vegetables, meats and other ready-to-eat products with lightning speed. Recent studies tell us that in these environments, Listeria is, in fact, a significant concern. Of nearly 5,000 randomly collected samples from the food preparation areas of 30 separate retail grocery establishments, approximately 10 percent tested positive for Listeria monocytogenes. In light of the fact that nearly 16 percent of all people who become infected with Listeria will die, the numbers are alarming. The lesson for us all is that, once Listeria is introduced into the processing environment, it can easily spread and contaminated finished products. Blue Bell learned its lesson the hard way. So, too, will many additional food companies (including, perhaps, yours) if they do not take heed. At the outset, the Blue Bell example confirms that, once Listeria is allowed to enter the food processing environment, no food product (not even ice cream) is safe. If food companies do not take extraordinary steps to identify any Listeria in their facilities, perform a comprehensive investigation to find the root cause or source, and then destroy and eliminate it completely, Listeria will continue to persist and, over time, intermittently contaminate their finished products. Wishful thinking is not enough. Blue Bell also demonstrates that, in the event there is any Listeria persisting in a food processing facility, it is becoming increasingly likely that the government will discover the problem. State and local public health agencies are now testing food products at retail for the presence of pathogens like Listeria, and FSIS and FDA are now testing, during their routine inspections, the food processing environment. In its attempt to find Listeria in one of my client’s facilities during a recent routine inspection, FDA took nearly 300 environmental samples. This is only one example of dozens I have witnessed over the past six months. As a result, if Listeria exists in your facility, the government will likely find it. The second warning that Blue Bell provides is that if your food products have made anyone in the U.S sick within the past 5 or more years (yes, that’s 60 months), then FDA can and will use the positive findings from your facility to link your company to those illnesses. CDC maintains a database of the DNA signature of every person confirmed to be sickened with Listeria (or any other pathogens) in the past 15 years. If the DNA pattern of the Listeria FDA finds in the floor drain of your food processing facility matches the strain of a former victim in the CDC database, FDA may link that illness to your product and then mandate an extraordinarily broad recall. This stark reality was illustrated in the Blue Bell investigation. There were a total of seven case patients in the CDC database who carried the same strain of Listeria found in Blue Bell’s facilities. What makes the investigation most concerning for industry is that the first people who got sick in the outbreak became ill more than five years ago. Indeed, the first illness was reported in January 2010. Two more illnesses were recorded in 2011. There was only one illness 2012, and three in 2014. The final illness was reported in January 2015. Once FDA found the same strain in Blue Bell’s facilities that sickened these people, the agency urged the company to recall all of its products. Although we will never know how many finished products that Blue Bell shipped were ultimately contaminated, what remains clear is that a large amount of product was unknowingly becoming contaminated within Blue Bell’s facilities over a long period of time. So, what lessons does Blue Bell provide? First, all food companies need to start testing for Listeria (or for other pathogens, depending upon the risk profile of their products) in their facilities. If food companies are already testing for Listeria, they cannot continue to ignore sporadic or intermittent positive findings. Although many food companies view an outbreak as something that will be caused by a single operational failure (which will be obvious and limited in scope when it occurs), the reality is that the culprit is in most cases something far more subtle, far more persistent, and far more dangerous. In the past few years, we have witnessed a large number of outbreaks involving Listeria and antibiotic-resistant Salmonella linked to products that had been processed over multiple months. The final warning that Blue Bell rings is that, if you don’t aggressively find and control Listeria in your processing environment, the government will. And, when they do, the results could put your company out of business. I have seen numerous companies cease to exist in the past 12 months because they let FDA find Listeria in the facilities, on their equipment, and in their products before they could react. What should your company do in response to this ringing bell? All food companies should immediately arrange for and conduct a microbiological profile of their operations to find any potential environmental contamination that might exist within their facilities. To do it right, I strongly recommend that all food companies arrange for and conduct a comprehensive one-time microbiological profile for pathogens in their food processing facilities. For companies at risk for Listeria, the type of testing may vary depending on the product and process flow, but I would generally recommend looking for Listeria sp. (with LM confirmation) in Zones 2-3 and Zone 1 after equipment has been broken down and sanitized. The sampling should be completed, and the test results reported, before the equipment is reused. Once the results are reported, the company can address any positive findings, determine the original source of the contamination to completely eliminate it, and then develop a microbiological control and monitoring program to ensure that the pathogen remains controlled. This way, when FDA arrives to aggressively look for Listeria in your facility, you will already know what they will find, which is nothing. And, in this regard, survival requires preparation. If the testing you perform is directed by, and then reported through, a lawyer, the results will fall under the cloak of the attorney-client privilege, and you will be able to keep the results out of your food company’s operational files and governmental hands. Ultimately, it is far better to find a problem yourself than to let FDA find it when they start sampling during their next inspection. Many dangers in our lives, like the risk of crossing a busy intersection, are quite obvious. Many more, like the risk of smoking, are more subtle. When it comes to food, the perils are in most cases invisible. Because the perils are invisible, they are also extremely dangerous to your customers and company. As a food industry attorney, I help food companies avoid repeating the mistakes that will destroy their brand. I urge all my clients to source safer ingredients, improve their food safety programs, and produce a safer product. Knowing where your ingredients come from, and managing how they are processed, is the single most important thing you can do to protect your customers and your brand. If I were Blue Bell’s lawyer, I would have told them to find and destroy the Listeria persistent in their facility. Had they listened, lives would have been saved, an outbreak would have been averted, and the company would have never needed a recall. Indeed, most of the food product recalls I manage and most of the foodborne illness outbreak lawsuits I defend could have been prevented. Moving forward, we need to do a better job. Let’s work to put food lawyers – not food companies – out of business. Let Blue Bell ring a warning to us all.
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