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The Risks of Waiting
The Risks of Waiting

Whether you’re busy with end of the year orders to fill or struggling with line worker retention there is always something that could be prioritized in front of preparing for the upcoming Intentional Adulteration rule.

“Most facilities are finding complications with conducting the vulnerability assessment because the requirements are so detailed,” said Earl Arnold, Food Defense Expert at AIB International. “It’s affected so many from small businesses to the manufacturer powerhouses.”

Unlike the first compliance rules, Intentional Adulteration is not an exact science and is met with confusion. This regulation outlines the required actions FDA-registered facilities must take to prevent intentional adulteration of the food supply. The responses and comments section in the final regulation and recent draft guidance was developed to explain FDA's current thinking on the topic. The Intentional Adulteration Rule has a compliance date of Summer 2019 for other than small and very small businesses. Being proactive is critical or a facility could suffer these consequences.

The Importance of Complying

It all starts with results from an audit. The FDA could issue Form 483, which would include observations and shortcomings. Another result of non-compliance could be receiving a warning letter from the FDA.

If the observations were severe enough the FDA could revoke their registration, said Arnold. A withdraw of FDA registration means that until a facility regains their registration they would not be able to produce and ship product. Not one single facility is similar in production so finding the right solutions for Intentional Adulteration compliance does take time and consultation.

For over 20 years, Arnold has been conducting training sessions, consulting with many multi-facility clients, and performing audits. From that experience, he’s noted that very few facilities are currently preparing their intentional adulteration plan.

The IA rule requires facilities to develop a food defense plan. The food defense plan consists of:


The vulnerability assessment needs to assess all products and processing steps within the facility. You need to consider the potential of these four contaminants being added to your products with the intent to cause wide scale harm. (biological, chemical, physical, and radiological). During the assessment for each processing step you need to also consider these three fundamental elements, (Access to the product, ability to contaminate product, and public health impact if a contaminate were added).


If a significant vulnerability is identified, then this processing step would be considered actionable. If an actionable processing step is identified, then mitigation strategies are required to significantly reduce or prevent the identified vulnerability.


If mitigation strategies are required, then facilities must implement the management components. These are Food Defense Monitoring, Food Defense Corrective Actions, and Food Defense Verification Activities.


Policies and written procedures are required for all steps within the program and these items will need to meet the records requirements within the regulation. Here is an example of how these items can be completed. It is not the only way to meet these requirements but gives you an idea on how to complete the requirements.

See the Food Defense Plan Example here

Rest assured that more FDA guidance will become available in due time, and AIB International is doing things the right way to assist facilities in compliance. Even as our consultants are hustling to keep up with the volume of clients we guide, there’s a still calm in the air before Summer 2019. AIB International consultants won’t be rushed or compromised along the way and they won’t settle for anything less than unparalleled service. Neither should you.

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