COVID-19 and Intentional Adulteration

While consumer demand for food at retail rose due to more people eating from home and retailer expectations increased to promptly meet that demand, food manufacturers encountered an array of obstacles to support increased production. Impacted by ingredient and supplies shortages, including a shortage of personal protective equipment and sanitizing solutions, some manufacturers even turned to their crisis management plans to help mitigate the initial impacts. Personnel then began falling ill with the virus, and additional measures and restrictions were enacted around the world to help control the spread of the disease. Suddenly, the pandemic had upended the food industry’s “normal.” For many, it’s also added new complexities to complying with the IA rule.

Revisiting Your Food Defense Plan

In 21 CFR 121.157, the IA rule states that a reanalysis of your food defense plan should be conducted every three years but should be done earlier (the complete food defense plan or sections of the food defense plan) “whenever there is a significant change made in the activities conducted at the facility, whenever new information becomes available about potential vulnerabilities associated with the food operation or facility, whenever the mitigation strategies are not properly implemented, and whenever the FDA requires reanalysis to respond to new vulnerabilities, credible threats to the food supply, and development in scientific understanding.”

While the IA rule is very clear in its statements regarding the reanalysis of your food defense plan and when it’s necessary to do so, there continue to be questions about how these plans should be updated and where to start. Two of the key reasons for reanalyzing your food defense plan and a good place to start with that review are based on those “significant changes” (21 CFR 121.157 (b)(1)) and “potential vulnerabilities” (21 CFR 121.157 (b)(2)) as defined in the rule. In response to the pandemic and the associated operational disruption, there have been “significant changes made in the activities conducted at the facility” by most manufacturers, as specified in the IA rule. As the impacts associated with the pandemic have been so fluid, it is also likely that “new information becomes available about potential vulnerabilities associated with the food operation or facility,” again as noted in the rule. Each of these scenarios should be analyzed to determine how they impact your food defense plan.

These operational disruptions may have occurred for any number of reasons, including increasing the focus on employee health and safety through the use of face masks and face shields; entering the facility only after a temperature check and sometimes even after participating in a health check assessment; adjusting infrastructure to comply with required social distancing or the addition of physical barriers on production lines, in breakrooms, locker rooms, and meeting rooms; rearranging personnel schedules to avoid large gatherings; and reallocating or hiring staff to meet increased production demand. Each of these changes and many others made in response to the pandemic are worth analyzing as part of the implementation of your food defense plan.

For instance, as an example of a change made during the pandemic, employees may not be appropriately donning and doffing their face masks. This may result in an environment where the coronavirus is actively being spread to others by an asymptomatic employee in the immediate area. It then becomes worth considering whether a non-compliant employee is doing this on purpose and, if so, determining whether the employee is intentionally contaminating their surroundings and the manufacturing area they work in. Another example could be the reduction of all-staff meetings to avoid contact in large groups. This may create an environment where communication breaks down and employees are not receiving complete directions about updated processes or procedures they should comply with, such as the behaviors expected in the facility and the correct ways to monitor the mitigation strategies.

The Path Forward

If it is found that these or other changes to the operation develop into a significant vulnerability that needs a mitigation strategy, or these changes are keeping mitigation strategies from being properly implemented, then additional strategies will need to be implemented. Further training and supervision may also be necessary and warrant increased involvement of HR. This will help ensure that all of your personnel receive the necessary support and direction in this new normal, while limiting the number of disgruntled employees in the facility. Situations that create new significant vulnerabilities without corresponding mitigation strategies could be considered potential violations, and non-compliant, as the FDA inspects the facility as part of the IA rule.