factory worker checking bottle on production line for flaws

Intentional Adulteration: What Does FSMA Mean?

Denis Storey
February 13, 2020

Smart Alerts: Monitor threats and regulatory risk for your supply chain in real time.

Learn More

Smart Alerts: Monitor threats and regulatory risk for your supply chain in real time.

Smart Alerts monitors threats and regulatory risks throughout your supply chain in real time, to prevent food safety issues and supply chain disruptions. The system transforms massive amounts of data into user-friendly, actionable insights for fast and effective risk management.

Learn More

The Food Safety Modernization Act (FSMA) authored the Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration to prevent wide-scale harm to public health. Acts of food terrorism can have long-lasting impacts upon the food supply and cause economic disruption, illness, and even death. While most FSMA rules focus on possible hazards, this rule is unique, as it provides guidance on mitigation and risk-reducing strategies for specific processes in individual registered food facilities. 

Food Defense

The term "food defense" refers to the intentional adulteration rule, where four subcategories of activities are discussed. Each category deserves individual attention under the Final Preventive Controls Rules for Human and Animal Foods.

Economic Adulteration 

Economic adulteration is a forgotten cornerstone of the Food, Drug, and Cosmetic Act (FD&C Act) from 1906. Companies passing inferior ingredients as superior or whole, the definition of economic adulteration, led to the passing of the act back in 1906.

It is the Food and Drug Administration's (FDA) stance that economic adulteration is motivated by economic gain, more than large-scale public harm. Because of this determination, economic adulteration, though still intentional, is covered as part of the Hazard Analysis and Risk-Based Preventive Controls (HARPC). 

Disgruntles (Employees, Competitors, and Consumers)

Disgruntled employees are considered individuals who seek to tarnish the reputation of, or seek revenge against their employer. The most famous of these instances was a Kellogg's employee who posted a video of himself urinating on a conveyor belt of Rice Krispies and is now serving jail time due to his gross misconduct. While this and other forms of adulteration by disgruntled parties may have momentary brand ramifications, they do not carry the large-scale intentional harm required for regulation under the Intentional Adulteration rule, and are subjected to regulation under HARPC. It is hard to think that urinating on the production line could be part of some company's food safety plan, but that may be the case for Kellogg.

Similar activities can happen with competitors or disgruntled consumers. Still, the FDA states these tactics are more about seeking revenge against the company from a consumer or competitor standpoint rather than harming.

Large Scale Public Harm

Unlike the examples listed above, acts of terrorism targeting the global food supply to cause wide-spread harm to public health falls well within the FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration because of its scale.  


Performing vulnerability assessments to determine areas of operation to be included in a food defense plan is the key to the Intentional Adulteration Rule. This rule is inclusive of all but a few facilities (e.g., dairy) and requires completion of a vulnerability assessment. 

Each facility has two approaches.

Approach 1: Determine if production activities fall into these four categories:

  • Bulk Liquid

  • Liquid Storage

  • Secondary Ingredient Handling

  • Mixing and "Similar Activities"

Approach 2: Conduct a vulnerability assessment. Include raw materials, finished goods, and shipping processes, independent of the categories listed under Approach 1, to determine where the vulnerabilities might be. The FDA provides a number of resources to help aid in this process. It highly recommends the CARVER plus shock vulnerability assessment to identify areas within the facility requiring mitigation steps.

The two approaches listed above are similar and very broad. Both options cover the facility's full extent and identify areas where a vulnerability might exist.

Similar Concept?

The framework for the Intentional Adulteration Rule and the food defense plan both begin with vulnerability assessments. The goal is to identify significant vulnerabilities and take the necessary steps to prevent intentional adulteration in those areas. HACCP-style methods where the term "critical control points" is used are similar. When it comes to Intentional Adulteration Rule, "critical control points" equate to "actionable process steps," but the process is the same. Also, in HACCP plans, physical or chemical hazards are the goal, where intentional adulteration focuses more on vulnerabilities that can be mitigated by the food defense plan.

Mitigation Strategies mitigate or prevent significant vulnerabilities at each step. These strategies are tailored specifically to your facility and must match your process steps. In addition to matching the process step, you must justify the use, align to a schedule, and identify the corrective actions needed. 

Below is a list of some of the common mitigation strategies that are typically outlined under each category.

  • Bulk Liquid – Controlling access to receiving/loading, adequate lighting in receiving/loading, security/observation, driver check-in policy, verify seals

  • Liquid Storage – Controlling access to storage, one-way sample ports, inspecting tanks before filling, inspecting pumping or metering equipment

  • Secondary Ingredient Handling – Control access to handling areas, restrict ingredient handling access, use enclosed or automated handling equipment, peer monitoring

  • Mixing and "Similar Activities" – Controlling access to processing areas, ensuring areas are free of unrelated materials, maximize visibility, inspect mixing and other equipment before use

In the following steps to monitor, correct, and verify, the food defense plan is similar to HACCP food safety plans. Monitoring ensures the proper procedures are in place, setting a frequency to verify the mitigation steps are in place, and ensure the plans are working. 

Food defense training and recordkeeping are also necessary. Use Document training, monitoring, verification, and correction activities for compliance purposes.

Smart Alerts ensures businesses never miss a critical threat with automatic alerts for items, ingredients, and formulas, and daily updates on new and emerging supply chain threats. While also allowing companies to pinpoint risk research by item or ingredient, country of origin, threat type, supplier, or date of event. Learn more about Smart Alerts here