FDA Release Guidance on Food Defense - Mitigation Strategies to Protect Food Against Intentional Adulteration

The FDA published a draft guidance for food defense titled Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry in support of the Prevention of Intentional Adulteration rule. The draft guidance provides ways to meet the requirements in the rule specifically conducting the vulnerability assessment and putting mitigation strategies in place for ‘actionable process steps’ or APS. These APS are defined as “a point, step, or procedure in a food process where a significant vulnerability exists and at which mitigation strategies can be applied and are essential to significantly minimize or prevent the significant vulnerability”.

To summarize the 159 page document - a Food Defense Plan is essentially conducting a HACCP type of analysis where the goal is to find steps in the process where significant vulnerability exists and to put in measures, or the mitigation strategies’ to reduce the vulnerabilities. These vulnerable points are points where there is access to product where the product can then be contaminated.

There is flexibility in how one conducts a vulnerability assessment, but the guidance provides some basic ways. The elements that must be considered include 1) the potential public health impact (e.g., severity and scale) if a contaminant were added, 2) the degree of physical access to the product; and 3) the ability of an attacker to successfully contaminate the product. The analysis must consider an attack by an insider, a person working in the company. The written assessment must document why each step was considered, or not considered, an APS.

For steps designated as an APS, mitigation strategies are put in place. These strategies may limit access to the step, or may reduce the likelihood that someone can contaminate product at that step. Like critical controls points, each mitigation strategy must have monitoring, verification, and corrective action.

While many may ask about facility wide measures – items such as exterior fencing, employee access to the facility and such – these are not included within the plan unless they can be tailored to impact a specific Actionable Process Step. Sure, they are important, but many have these in place already for other purposes and in reality, they are harder for regulators to regulate.