Most readers of these periodic food defense articles are familiar with activities associated with the design and implementation of a Food Defense Plan (FDP) that complies with the requirements of FDA 21 CFR 121, Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule). The rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Many of your facilities are, or soon will be, operating in compliance with provisions under this regulation. It’s useful to revisit the role of required monitoring.
Food Defense Plan Basics
Food defense monitoring is defined by the FDA as follows: “To conduct a planned sequence of observations or measurements to assess whether mitigation strategies are operating as intended.” Food defense monitoring procedures must be performed at sufficient frequency and include keeping records, as appropriate, to the mitigation strategy’s nature and management component and its role in the facility’s food defense system. (See 21 CFR 121.140)
Food defense monitoring is conducted by appropriately trained food defense individuals who can assess whether mitigation strategies are operating as intended (21 CFR 121.3) and with adequate frequency (21 CFR 121.140(b)). Food defense monitoring is just one of three mitigation strategies management components. The other two are food defense corrective actions and food defense verification.
Regulations require your facility to apply appropriate mitigation strategies management components by considering the nature of the strategy and its role in your facility’s food defense system to ensure its proper implementation. (21 CFR 121.138). As purposely written into the rule, your facility has the flexibility to identify and implement food defense monitoring procedures that are appropriate for your own unique operating environment. Your facility must first determine if it has Actionable Process Steps (APS), which are points steps or procedures in a food process where significant vulnerabilities exist, at which mitigation strategies can be applied, and that the strategies are essential to significantly minimize or prevent the significant vulnerability. If there are no APSes, then your facility wouldn’t need to establish mitigation strategies.
Some aspects of food defense monitoring are similar to the food safety monitoring requirement as part of the Preventive Controls for Human Foods (21 CFR Part 117) rule (and Preventive Controls for Animal Foods 21 CFR Part 507). For example, each preventive control is monitored as appropriate to the nature of the preventive control and its role in the facility’s food safety system. The same requirement applies to the Food Safety Modernization Act IA rule.
Food safety monitoring is more likely than food defense monitoring to document that the minimum or maximum values for parameters have been met. With food safety hazard control, monitoring is frequently assigned as a continuous process. Food defense monitoring, in comparison, often occurs less frequently. Monitoring can be continuous, or periodic, and monitoring intervals can frequently change. For example, mitigation monitoring activity frequency will be heightened when there are access points to production areas that contain APSes and where there’s no continuous mitigation monitoring system available, such as in the use of continuous surveillance CCTV.
As with the design, implementation and monitoring of a Food Safety Plan or FDP is no less important. However, monitoring procedures, the frequency of monitoring, and who’s assigned to conduct the monitoring may be different. In some cases, the same employee may monitor both food safety hazard control and food defense mitigation strategies in areas they are familiar with and stationed at. Also, a food facility experiences normal changes in physical facility, equipment design and installation layout, changes in personnel, and changes in food ingredient and packaging materials involved in production around APSes. As these changes occur, so might the vulnerabilities and their assigned mitigation strategies, which may not remain effective. Monitoring can determine if an FDP needs to address the effectiveness of implemented mitigation.