Nearly two decades ago, before the Food Safety Modernization Act (FSMA) was enacted, food manufacturing facilities prepared themselves to protect the food supply from a threatened or actual terrorist attack by following the requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, also known as the Bioterrorism Act. As a result, manufacturers were asked to consider the possibility of intentional adulteration for widescale public harm and took precautions to avoid it.
Under the law, manufacturers outside of the U.S. registered with the FDA and provided advance notice of their food shipments entering the country, among other requirements. Initial precautions were also intended to guard against intruders entering manufacturing facilities. For some, this included installing reinforcement gates, posting guards at facility entrances who were trained with protocols to ensure that only approved people entered the facility, investing in CCTV to monitor the exterior of the facility, and implementing additional security procedures. These efforts have helped keep strangers from entering manufacturing facilities and harming the public through food adulteration.
Then, in January 2011, FSMA was signed into law and, on May 27, 2016, FDA issued the Intentional Adulteration (IA) final rule (21 CFR 121: Mitigation Strategies To Protect Food Against Intentional Adulteration). This rule, also referred to as “the Food Defense rule” or “the IA rule,” was initially scheduled for implementation in May 2019, three years after the final rule was issued. However, FDA modified the implementation dates to start in July 2019, with three different compliance dates, depending on FDA’s description of business size.
One of most significant differences between the Bioterrorism Act and the IA rule is that the latter requires food facilities to implement mitigation strategies not only for keeping external intruders from entering the food facility, but also to prevent a person or people already inside the facility from intentionally contaminating food with the goal of extensive public harm. In reviewing your food defense plan, it’s worth considering how to best respond if an employee or contractor is persistently non-compliant with the rules of the facility or exhibits other behavior that can negatively affect the operation. This is particularly important if the behavior can impact the implementation of one or more mitigation strategies, which would necessitate corrective actions and sometimes even a modification of the impacted mitigation strategies or a change of the person or people responsible for monitoring them.
Another significant difference between the Bioterrorism Act and the IA rule is the involvement of the human resources (HR) department. Because the focus of the Bioterrorism Act was to prohibit external people from entering the facility, and internal personnel behaviors were not necessarily considered, the role of HR was not fundamentally as significant as it is now. Complying with the current IA rule necessitates looking at both external and internal threats, so it’s important that the HR department be involved as part of the food defense team.
Since the introduction of the IA rule, manufacturers have prepared by implementing their food defense plan per rule requirements, finalizing their written vulnerability assessment, implementing the mitigation strategies chosen by the facility to minimize or reduce the risk in the corresponding step of the process where a significant vulnerability is identified, and ensuring their personnel are trained as qualified individuals to comply with the law. While each manufacturer has been challenged in modifying their programs to attain compliance with the IA rule, most have found a way to fulfill the requirements and are confident in their preparedness.
However, COVID-19 has introduced some complexities.
Just as FDA inspections for the IA rule were scheduled to begin in March 2020 for certain businesses, domestic and foreign inspections were postponed due to the emerging global pandemic. Although the coronavirus (SARS-CoV-2) that causes COVID-19 is not a food safety issue, as it is understood that it is not transmitted by food or food packaging, its impacts on the food industry have been unprecedented.
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.
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.
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.
As you continue to navigate through the pandemic and make further changes to accommodate evolving circumstances, analyze the impacts of these changes to determine whether they should be considered potential vulnerabilities as part of your food defense plan. Taking such an approach will help ensure compliance with FSMA’s IA rule, even during these difficult circumstances.
Bernal is manager of quality assurance, Latin America, for AIB International. Reach her at firstname.lastname@example.org.