Whether it happens next week or whether it happens next year, and whether you want them to or not, U.S. Food and Drug Administration (FDA) investigators will arrive unannounced in the lobby your facility to conduct a food safety inspection. The regulatory activities that follow could last anywhere from a few days to a few weeks, or even a few months. During the inspection, FDA investigators will: (1) closely review your company’s food safety programs; (2) perform an exhaustive visual inspection of your facility; and (3) conduct extensive microbiological sampling (an “FDA swab-a-thon”) focused on your ingredients, your food processing areas and your finished products. The results of FDA’s inspection could have drastic consequences for your company, leading to large-scale recalls, threats to shut your company down and, in some cases, FDA and Department of Justice (DOJ) criminal investigations.
Indeed, long gone are the days when FDA reached its conclusions regarding the sanitary conditions of a food facility based only upon the agency’s visual observations obtained during an inspection. Today, the current version of the FDA food facility inspection is much different. During routine inspections, FDA is now basing its conclusions regarding the sanitary conditions of your facility based upon the results of the agency’s expansive and intensive microbiological sampling of your ingredients, your food production equipment and your finished products. The agency will likely collect and test more than 100 samples. And, for the first time in history, FDA regulators are now in some cases urging food companies to recall their products based upon positive environmental findings collected from non-food contact surfaces located within the facility.
But, that’s not the only consequence facing your company when FDA investigators find evidence of contamination in the food processing environment. In every inspection, FDA investigators will now compare the DNA signature of any positive samples collected from your facility (including from your drains) against the national PulseNet database of nearly one million human isolates collected since 1998 to determine whether the pathogen found in your facility matches a human foodborne illness. The vast majority of the human foodborne illnesses recorded in the PuseNet database remain unsolved and, if there is a match, FDA will, in most cases, presume that the products produced in your facility were the original source of the illness. In addition to requiring expansive recalls, because your products were allegedly associated with human illness, FDA and DOJ may in many cases now also launch a criminal investigation to determine whether there is any basis to bring criminal charges.
If a criminal investigation is initiated, the federal government will serve subpoenas seeking all emails, food safety decisional documents and other records relating in any way to the plant operations and safety of the product. Under the federal standards, the government can bring criminal misdemeanor charges against the company owners, executives or managers if they were aware of any condition that “could” possibly lead to product adulteration, even if they had no knowledge the company was actually producing contaminated products. Based upon the conclusions of the government’s criminal investigation, a company owner, executive or manager could face criminal misdemeanor penalties ranging anywhere (per count) from a $250,000 fine to a year in prison.
In most cases, a food company’s routine environmental monitoring program is not designed to detect resident pathogens in all areas within the facility. In addition, when sampling is being conducted as part of such programs, the sampling is in many cases only being performed following the cleaning and sanitation of the areas being sampled. As a result, these programs will rarely (if ever) identify persistent strains of existing pathogens. In turn, when FDA arrives during its next inspection, it will sample these areas extensively and, in many cases, a high-percentage of the samples (collected without the benefit of cleaning and sanitization) will test positive for pathogens of concern. As noted, the consequences can be catastrophic.
Any foodborne illness outbreak constitutes a food safety failure. The best way to avoid criminal charges for pathogens in your drain is to invest in additional strategies (before FDA arrives) to better understand and control pathogens in your processing environment, and to produce a safer product. During our session on May 11, 2017 at the Food Safety Summit, which includes representatives of industry, CDC and DOJ, we will explore the new FDA and DOJ policy, and discuss the steps you can take today to avoid becoming the government’s next target tomorrow.
Visit FoodSafetySummit.com for details on how to register for the upcoming event.
Shawn Stevens, Esq., is a national food industry lawyer at Food Industry Counsel, LLC.
