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Tip of the Week: Intentional Adulteration Rule: FDA Clarifies Training Requirements
Tip of the Week: Intentional Adulteration Rule: FDA Clarifies Training Requirements

Last week the FDA added to the current draft guidance on the Intentional Adulteration Rule (21 CFR 121) then published for review and industry comments. The draft document is the latest communication in the ongoing IA rule discussion leading up to the July 2019 deadline for those other than small and very small businesses defined by the FDA. A total of 65 new pages were added and reviewed by AIB International’s Food Defense Consultant, Earl Arnold.


The new guidance adds to and incorporates elements of the previously published guidance with changes in:

  • the components of the food defense plan;
  • how to conduct vulnerability assessments by
    • using the four Key Activity Types method (bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, mixing and similar activities),
    • evaluating the Three Fundamental Elements (potential public health impact, degree of physical access to the product, ability of an attacker to successfully contaminate the product)
    • using a Hybrid Approach, which is a combination of the Key Activity Types and Three Fundamental Elements methods;
  • how to identify and implement mitigation strategies;
  • food defense monitoring requirements;
  • education, training, and experience.

Like all draft guidance from the FDA, once the industry review period is over, the guidance document could change based off comments.


The biggest change boils down to Chapter 2. At the beginning of this chapter, the FDA stresses that a facility can utilize any methodology to conduct the vulnerability assessment as long as the requirements are captured. According to the FDA, this chapter reasons why and how facilities need to consider an insider as the biggest threat.

In the previous draft only one type of methodology was discussed. In this draft the FDA included how you could conduct a vulnerability assessment using the three elements methodology as well as providing example forms and describing how this process could be done. Additionally, FDA discusses one more type of methodology they call the Hybrid approach; combining the Key Activity Type assessment with the three-element assessment. Examples of forms and completed assessments were included.

“The FDA did a great job explaining how the Intentional Adulteration Rule could be assessed and what you may want to consider.” said Earl Arnold, Food Defense Manager at AIB International.

As outlined in the draft, the FDA provides an example of how the three elements could be evaluated by using a scoring matrix. They clarified you do not need to use this method and a facility may use their own system. Arnold explains, one major addition FDA included was clarifying how a facility could assess element 1; Potential public health impact (e.g., severity and scale) if a contaminant were added. The FDA included three potential ways a facility could calculate this. The first method was to calculate the volume of food at risk. A facility could evaluate each processing step and determine if a contaminate were added how many servings would be at risk, followed by examples and formulas on how to do this. The second method included using a representative contaminate. The representative contaminate is not specific but includes scientific parameters for a wide spectrum of contaminates and this could be used to determine public health impact. The last example used a specific contaminate of concern. That alone is the most labor-intensive approach/difficult to complete but still an option.

Forms, formulas, and examples are provided for all three methods. FDA included information on considerations when assessing the other two elements such as how vulnerabilities may be minimized by inherent characteristics.

Inherent characteristics. Defined as; conditions, activities, practices, or characteristics that are integral to the operation of a point, step, or procedure; the point, step, or procedure could not properly operate without these inherent characteristics in place. That word, Arnold said, inherent characteristics are not easily changed or altered. FDA cautions not confusing inherent with non-inherent characteristics defined as; Non-inherent characteristics are unnecessary for a process step to function. Under the current rule, process steps will continue to function if non-inherent measures are improperly implemented. However, the FDA included information on how to include written justifications using these three types of vulnerability assessments and provided examples.


The eighth chapter is about training requirements. The FDA points out four roles and discusses training and qualifications:

  1. Individuals who perform activities required under subpart C (Food Defense Measures)
  2. Individuals assigned to actionable process steps
  3. Individuals performing or overseeing four specific activities (food defense qualified individuals)
  4. Supervisors  

FDA also discusses training frequencies and gives examples of when personnel may need to be re-trained. They state the following;

“Any individual performing activities that require education, training, or experience should have completed that education, training, or experience prior to undertaking the relevant activities. The IA rule does not include specific retraining frequency requirements; however, in most cases, individuals conducting activities with associated requirements for education, training, and experience should repeat training periodically and as necessary to ensure that they are qualified to perform their duties.”

At AIB International, the Food Defense Coordinator course highlights the training requirements of the regulation. A facility after taking this training may still need to train individuals on the actual actions such as specific facility procedures on mitigation strategies, but this course includes training for the four areas identified above.

Even though the FDA has made this statement several times on how they plan on assessing competency for qualified individuals, this was included in the draft update. “We are not establishing minimum standards for competency and do not intend routinely to directly assess the qualifications of persons who function as the food defense qualified individual, whether by their training or by their job experience. Instead, we intend to focus our inspections on the adequacy of the food defense plan. As necessary and appropriate, we will consider whether deficiencies we identify in the food defense plan suggest that the food defense qualified individual may not have adequate training or experience to carry out the assigned functions.”

Draft guidance and guidance documents are not legally binding for the FDA or a facility. Facilities may choose to develop their programs in any way as long as it fulfills the regulatory requirements. Food manufactures understand the questions and commentary back to the FDA is the most successful way to contribute to the IA rule and guidance.

If you have comments or questions you can reach out to the FDA by July 5, 2019, either electronically or through mail. Directions for either method can be found on the following webpage.

Or another option is to submit your questions via and AIB International will submit your comments to the FDA. If you have any questions concerning this blog, food defense, or food safety please let us assist. The more you know the better you can be prepared.

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Avatar  Konesh 2 years agoReply

Does all FDA registered facility have to have a food security program?

Avatar  Salena 2 years agoReply

If a domestic or foreign facility is required to register with the FDA and does not meet the following exemptions then yes they need to comply and have a food defense plan. The exemptions are listed below.

All USDA Regulated Products
Very Small Business (Some conditions need to be met to qualify for this exemption)
Holding of Food (except holding of bulk liquids in large storage tanks does not include totes, drums, or containers)
Packaging-re-packaging when food is not exposed
Farms (Produce Safety Rule)
Alcoholic Beverages (under certain conditions)
Animal Food or Feed
On-Farm Manufacturing (eggs, Game Meats)

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