Managing Agency Criticism and Criminal Exposure

Posted in Food Safety Education

As a FDA and USDA lawyer serving the food industry for nearly two decades, I have witnessed substantial changes in the way that food safety is regulated by these two agencies. While some might describe the evolution as the maturation of food safety, others may refer to it as somewhat chaotic. Regardless of how it is characterized, what is certain is that, when the food industry produce products that make people sick, the government has signaled that it may look for a basis to bring criminal charges.

Because of the new criminal exposures faced by the industry, all food companies should develop and refine programs in response. These efforts start by taking additional care when responding to Noncompliance Reports (NRs), Food Safety Assessments (FSAs), Notices of Intended Enforcement (NOIEs), Form 483s and Warning Letters. In many cases, we find that the agency observations contained in these regulatory compliance and enforcement documents are one-sided, incomplete or taken out of context. For this reason, a failure to respond to the assertions contained in these documents could leave a negative impression which is far different than reality or even the underlying facts.

In the event your company receives any of the above-described forms of regulatory criticism, you should endeavor to provide a written response. While responses to NOIEs and Warning Letters are in most cases mandatory (unless you want to lose your company’s registration or grant of inspection), responses to NRs, FSAs and 483s are in most cases considered optional. Nevertheless, given the current regulatory environment and new criminal liabilities, I would counsel you to always provide a carefully-articulated response.

When responding to the observations of FSIS or FDA, be sure craft responses in a manner which makes clear that you take your responsibility to produce a safe product seriously. Then, put those observations into the appropriate context, outlining the circumstances surrounding the observation in manner that captures the underlying facts. Also, in many cases, it will be appropriate to look for and articulate the reasons why the agency observations do not amount to a direct food safety concern. While an insanitary condition may in fact be insanitary, for example, it may have been observed in a location or part of the facility that has no correlation to the production of any food products.

In those cases where an observed condition should not have occurred, the company should not be dismissive. Rather, the response should summarize the underlying circumstances, put the issue into the appropriate context, and then summarize the corrective actions the company is taking in response. By doing so, the company will provide adequate assurance to the agency that, although it disagrees with the significance of the findings, it is nevertheless taking action to make sure they do not reoccur.

Finally, following a food safety inspection by FSIS or FDA, never sign an affidavit without legal counsel. You have no obligation to do so, and the information you attest to can in many cases be abused. Rather, wait for the agency to provide its observations, and then spend time crafting an appropriate and well-thought out response. If you respond appropriately, there is a much lesser chance that the information contained in the agency’s inspection records can be misused to support additional regulatory or criminal enforcement actions.