Food Defense Mitigation Strategies

Food Defense Mitigation Strategies

Preventing Intentional Adulteration
In part two of our five part series we discussed the requirements for conducting vulnerability assessments and the differences between the key activity type (KAT) and the three element method. In today’s post, part three, we discuss the requirements for implementing mitigation strategies when actionable steps, i.e. significant vulnerabilities, are identified in your process.
Food Defense Vulnerability Assessment

What are food defense mitigation strategies?

Mitigation strategies are defined by the rule as those risk based, reasonably appropriate measures that a person knowledgeable about food defense would employ to significantly minimize or present significant vulnerabilities identified at actionable process steps. Those measures must also be consistent with the current scientific understanding of food defense at the time of the analysis.  

For example, your food defense team has identified a significantly vulnerable step in your process where a mixer is oftentimes left unattended with product inside. A mitigation strategy may be to control access so no unauthorized personnel would be allowed to access the mixer during vulnerable times.

Are mitigation strategies required?

As per 21 CFR 121.135, you must identify and implement mitigation strategies at each actionable process step. If you think of it like a food safety plan, the mitigation strategies part is similar to your critical control points. These are critical steps in your process where controls must be put in place and monitored for effectiveness in order to prevent the identified food defense hazard(s) from happening.

What are the requirements?

As stated above, for each identified actionable process step in your process, you must identify and implement mitigation strategies in order to significantly minimize the risk for intentional adulteration of your products. Remember, an inside attacker is likely your biggest threat. Also, for each mitigation strategy implemented, the facility must also provide an explanation of how the mitigation strategy prevents or significantly reduces the vulnerability associated with the actionable process step.

For instance, in the example given earlier where controlling access to an unattended mixer has been identified as a mitigation strategy at this actionable process step, an explanation of why the mitigation strategy was chosen might look like the following:

Access to the mixer will be controlled by closing and securing the lid with a combination padlock where only approved personnel have the code to open the lock. This will prevent unauthorized personnel from accessing the mixer and potentially adding a contaminant to the mixer while it is left unattended.

Both the strategies and explanations that are developed must be written and directly relate to the significant risk that was identified during the vulnerability assessment.

The Mitigation Strategies Database

A helpful tool
Deciding on an effective mitigation strategy can be difficult at times. To help with this process, FDA has developed the Mitigation Strategies Database to assist facilities with generating ideas to prevent acts of intentional adulteration at actionable process steps. The database consists of several drop down menus that the user can follow that ultimately leads to a list of mitigation strategy ideas. This is a great tool to assist your food defense team with picking the right strategy for your company.  An example of what the database looks like is below:
Food Defense Mitigation Strategies Database

Management Components

Once the food defense team has decided on the proper mitigation strategies, the team must then develop management components to ensure mitigation strategies are being properly implemented.  Those management components are:

1. Food defense monitoring

2. Food defense corrective actions

3. Food defense verification

C. Contaminant-specific analysis

In Part 4 of our food defense series, we will explain the mandatory requirements in the management components section, which is  21 CFR 121.138.


In our Intentional Adulteration - Conducting Vulnerability Assessments course, we provide attendees with guidance on developing appropriate mitigation strategies and explaining how those strategies effectively minimizes or prevents the identified hazard(s) from occurring.   Register for one of our upcoming classes or contact us today to schedule your in-house training. We are approved for both virtual and in-person training!

About the author

Food Safety Specialist Lance Roberie

Lance Roberie

Food Safety Consultant and Trainer

Lance Roberie has over 20 years of quality assurance and food safety experience within the food industry. Mr. Roberie holds the following certifications:

Lance and the Food Safety & Quality Services’ training curriculum will advance your team's food safety knowledge through certified training, consulting, and “real life” industry scenarios.

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