Under the FDA’s new mandate granted by the Food Safety Modernization Act (FSMA,) the FDA has preventive powers, including mandatory recalls and inspections, which it did not have previously; additionally, producers have a requirement to take action against the 31 known pathogens provided in the act. Of particular interest to the FDA right now is Listeria monocytogenes, a foodborne bacterium which they are studying intently and developing new guidelines to control—What is necessary to achieve FDA compliance with regard to this important known pathogen? And why the focus on it now?
Listera monocytogenes is a bacterium that is very common, even ubiquitous, in our environment—in soil, refuse, on doorknobs, practically anywhere—and which thrives from about 40 degrees Fahrenheit to over 96 degrees Fahrenheit, a range which starts at the temperature of many home refrigerator environments and approaches human body heat. Neither of these are unusual qualities among pathogens that cause food-borne illness—the key to food safety training is always to ensure that food processing conditions are not reflective of the wider environment or the temperatures at which foodborne bacteria flourish. But why is Listeria, in particular, such a threat?
There are two main reasons why the FDA is going after Listeria.
The first is the potency of the disease caused by the bacterium. Listeriosis has a case-fatality rate of about 20%, which is extremely high; for contrast, the case-fatality rate of salmonella, itself a notorious food-borne pathogen, is about 1%. To clarify, listeriosis has two variants—invasive and non-invasive. Non-invasive listeriosis presents as more or less a nasty case of gastroenteritis, like most foodborne illnesses, and is not usually particularly dangerous, not requiring hospitalization, though unlike other cases of gastroenteritis, it includes flu-like aches and pains, as well as headache. The fatality rate comes from invasive listeriosis, wherein the bacterium leaves the GI tract and enters the bloodstream to attack the central nervous system, or in pregnant women, the fetus (possibly causing miscarriage or stillbirth.) Unusually, when it attacks the central nervous system, the disease can manifest itself as meningitis as well as encephalitis, which is a very dangerous combination.
Most cases of invasive listeriosis occur in the elderly or immunocompromised, but the fatality rate is still extraordinarily high, and the usual course of treatment keeps patients hospitalized for two weeks or more on high doses of intravenous antibiotics. The especially dangerous nature of this infection is reason enough for the FDA to use its newly granted preventive muscle under the FSMA to shut down noncompliant processing facilities, but what else makes this pathogen the target of such intense FDA compliance efforts?
The second reason, and what makes this pathogen such a hot-button topic lately, is the high-profile case of Blue Bell Creameries in early 2015. When several hospital patients died of listeriosis after eating Blue Bell products, the FDA forced Blue Bell to recall certain of its products, which prompted a series of audits—both internal and external—and finally, after listeria was found in some half-gallons of chocolate-chip cookie dough ice cream, the recall of all Blue Bell products from all stores, a very dramatic event in the eyes of the American public. Listeria monocytogenes had been found in several of its plants in several different states and could potentially have contaminated a vast range of its products. It was revealed during this process that internal inspectors were aware of the problem, with multiple inspections at different plants noting dripping condensation from coolant pipes falling into mixing vats—yet nothing had been done about this until the hospital patients died.
No wonder the FDA is going after this bacterium so intently. With the FDA’s evolving policy view on the matter, food processing facilities must do all they can to stay ahead of the curve, as well. Even if the FDA does not conduct an inspection of your facility, you could still be shut down if you fail to take adequate steps under their new regulations. We know what poorly-controlled environments for Listeria look like, and they involve many Americans wondering if work days missed for a nasty stomach bug were in fact a lucky near miss for meningoencephalitis. Avoid endangering the public and your company by attending this on FDA Mandates For Controlling Pathogens with key updates from food safety lawyer and expert Shawn K. Stevens.
