In order to help you thoroughly assess all potential hazards from intentional contamination, we will present three methodologies developed by the Office of Analytics and Outreach, Food Defense and Emergency Coordination Staff, in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. We discussed the KAT methodology in the text from January 20, 2025:
In this article, we will focus on the three-element methodology: The Three Element Method.
Key Concepts (Requirements) that Companies Must Meet Regarding the Implementation of Food Defense Strategies
To protect the company from all potential (intentional) threats to product safety, it is necessary to prepare a written food defense plan, which includes:
Vulnerability assessment to identify significant vulnerabilities and steps in the process that can be taken;
Mitigation strategies for each step in the process that can be taken and written explanations of these strategies;
Food defense monitoring procedures to implement mitigation strategies;
Corrective action procedures for food defense that must be taken if mitigation strategies are not properly implemented;
Food defense verification procedures for verification activities, according to the nature of the mitigation strategy and its role in the food defense system at the facility.
Vulnerability Assessment The vulnerability assessment is a core component of your overall food defense plan. The vulnerability assessment can be conducted using the selected methodology. The preliminary steps for conducting a vulnerability assessment are:
Assemble the food defense team
Describe the product being assessed
Develop a process flow diagram
Describe the process steps
There are no mandatory requirements regarding which methodology to choose, but during every hazard assessment, the following should be considered:
Potential public health impact (e.g., severity and extent) if a contaminant is added;
Degree of physical access to the product, and
The ability of the attacker to successfully contaminate the product.
The Three Element Method Protection from intentional contamination by a company requires that vulnerability assessments, at every point, step, or procedure being assessed, take into account three elements:
Element 1: Potential public health impact (e.g., severity and extent) if a contaminant is added;
Element 2: The degree of physical access to the product; and
Element 3: The ability of the attacker to successfully contaminate the product.
The method assumes that all points and process steps have a certain degree of vulnerability. By assessing the degree of vulnerability, one can identify critical points that represent significant vulnerabilities, where special measures are implemented to prevent intentional contamination. This approach allows for consideration of specific aspects related to each point, step, or procedure in the vulnerability assessment. To carry this out, two key factors must be considered:
Internal Attacker, and
Intrinsic Characteristics.
How is the Internal Attacker Assessed? When conducting a vulnerability assessment, it should be assumed that the internal attacker has:
Legitimate access to the facility (e.g., employee, contractor, driver, authorized visitor);
Basic understanding of the facility’s operations and the food product(s) being produced;
Ability to acquire and apply a contaminant that is highly lethal, capable of surviving food production processes, and undetectable by simple observation if added to food; and
Intent to cause widespread harm to public health.
How are Intrinsic Characteristics Assessed? Intrinsic characteristics are conditions, activities, practices, or procedures at any point in the process without which the process would not function properly. Vulnerability is assessed at each point. Examples include:
Design of the food production space (e.g., layout of fixed equipment);
Type and nature of equipment (e.g., a process step that is completely enclosed and inaccessible during operation, such as piping, pasteurization, etc.);
The nature of the food being processed (e.g., whether the food is solid or liquid), etc.
Three Element Assessment
Element 1: Potential Impact on Public Health: This refers to how a consumer would be affected if they consumed a food product that has been intentionally adulterated. This can be assessed by calculating the implications of portion size at each step being evaluated, or by otherwise estimating the number of consumers who would be affected if an internal attacker succeeded in introducing a contaminant that could cause acute illness or death when consumed.
Element 2: Degree of Physical Access to the Product: This determines whether the internal attacker can indeed access the product at the step being evaluated. A scoring table (assessment matrix) is provided for this element. For example, if the product is “easily accessible,” it would represent the greatest risk and score a 10. But if the product is considered “hard to access,” it would score a 3.
Element 3: Ability of the Attacker to Successfully Contaminate the Product: This element focuses on determining whether the internal attacker could successfully contaminate the product if given the opportunity. The food defense team should consider factors such as:
Would the attacker have enough time to contaminate the food without being noticed?
Would the attacker need to engage in suspicious activities, and would other employees notice if the attacker successfully contaminated the product?
Could the attacker add enough contaminant to cause enough harm to cause acute illness or death if consumed?
If successfully added, would the contamination be homogeneously mixed into the food?
A scoring table (assessment matrix) is also provided for this element. Finally, for each process step, a written explanation is necessary to determine whether or not the process carries an elevated risk of attack.
If you would like to learn more about the Three Element Method (and other food defense methodologies), feel free to contact our Agency for assistance!