White Paper: FDA's War on Pathogens

Posted in FDA & USDA Inspections

As a food safety lawyer, I have always been, and remain, extremely interested in the increases in the numbers of foodborne illness outbreaks and food product recalls seen over the last decade.

Last year alone, there were over 500 food product recalls. Many of these recalls were triggered by the presence of harmful pathogens detected in affected food products, and many were the result of investigations following national foodborne illness outbreaks. In response to these alarming trends, Congress ordered the Federal Food and Drug Administration (“FDA”) to overhaul the safety of the food supply when it passed the Food Safety Modernization Act.

To execute this mandate, FDA is executing numerous policy changes. The agency is now conducting microbiological profiling inside food processing facilities during routine inspections and testing vast amounts of food at retail. FDA is also initiating criminal investigations against food companies (and their executives) who distribute food products that have the potential to cause human illness. Under the United States Supreme Court Park Doctrine, FDA can bring criminal charges against food company executives for a food safety failure, even if they had no direct knowledge of the failure or any intent. In turn, the FDA criminal investigations now involve multiple cases where food company executives had no direct knowledge that their food products were causing illness or had the potential to cause illness.

Many of these criminal investigations involve Listeria monocytogenes (“LM”) found either: (1) in food processing environments; or (2) in food products in commerce. Although previously FDA permitted food companies to occasionally detect LM in the processing environment (so long as the LM was controlled and did not contaminate food contact surfaces or products), under FDA’s new approach, the failure to eliminate sporadic LM findings in the environment completely may now subject companies to criminal liability. FDA’s aggressive enforcement initiatives targeting harmful bacteria can be reasonably characterized as “the FDA’s War on Pathogens.” These policies will continue to intensify.

The immediate challenge to the food industry is to find a more effective solution to identify and reduce ubiquitous pathogens like LM in the processing environment through the use of emerging pathogen-reduction technologies, while at the same time implementing written food safety protocols which, if followed, provide additional protections against criminal sanctions. The following White Paper, FDA’s WAR ON PATHOGENS [Criminal Charges for Food Company Executives and Quality Assurance Managers], details the emerging challenges confronting the food industry, as well as recommended solutions designed to determine the extent of any environmental contamination in the environment, to reduce any pathogens that may be present, and to decrease through written protocols potential criminal liability.