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.
Impact of COVID-19 on IA Compliance
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.