Defense is Your Best Offense – Guidance on the FSMA Intentional Adulteration Rule

Intentional Adulteration: It’s All About Defense!

On September 11th, 2001, America changed. While there were many undeniable shifts in the country, what many may not realize is that on that day, food safety changed as well. As a result of the events, in 2004 a presidential directive was given requiring the FDA and the USDA to begin working with the food industry, to decrease the risk of intentional tampering in the food supply. You may remember some of the changes made in the industry at that time. It was then that the idea of intentional adulteration became a threat, and a food industry focus on security measures for protecting product was born.

In 2011, when the Food Safety Modernization Act (FSMA) was created, one of the elements that congress required the FDA to include was a more robust approach to food defense. The solution to the food defense issue was the Intentional Adulteration Rule, a standard similar to what many food processors have in place, but with a twist. Many companies today have a “Food Defense” plan with facility security measures such as locking doors, installing fences, security cameras, protection of digital resources, and even mail controls. With the Intentional Adulteration rule, the FDA assumes these measures are being implemented. The new rule is meant to show that the FDA is looking for something more robust.

About the Rule

The purpose of the Intentional Adulterations Rule is to prevent intentional contamination of food with the intent to cause wide-scale harm (illness or death) to consumers. This rule, as with the Preventive Controls rule, applies to most companies who are required to register with the FDA as a food processor –the majority of the food processing industry. Both domestic and foreign companies who sell product in the U.S are included.

For readers that import products into the U.S., take note! Part of your “Foreign Supplier Verification Program” may soon need to include verifying that food defense controls are in place at your supplier’s facility.

Check out this article on FSVP for more information!

In true FSMA fashion, compliance dates are staggered based on Company size. There is also a delay in enforcement (see the table below). Notably, the cut-off for the size of “very small” companies, which are not required to comply with the rule fully, excludes many smaller processors. The cut-off for this rule is $10 Million.

The rule’s requirements can be summarized as follows:

• Develop a documented food defense plan
• Conduct an assessment of potential risks to the product from intentional adulteration. Adulteration may be committed by trespassers, visitors, or even employees.
  • Companies may either use the “KAT” approach (Key Activity Types) or attend training and use a more robust approach.
• Determine mitigation strategies (controls to reduce risk)
• Implement the plan
  • Train employees
  • Implement mitigation strategies
  • Monitor control measures
  • Apply corrective actions where needed
  • Verify the plan and its controls
  • Keep records
• Reanalyze the plan periodically

Living in a FSMA and GFSI World

In previous years food defense programs have been mostly voluntary and managed much like GMPs. Companies would use a standard checklist to assess their facility controls, like the tool from FSIS used by many manufacturers. While these types of resources can be helpful, they don’t meet the new requirements that the FDA has developed.

Under this rule, the FDA will expect to see a more robust program, similar to a HACCP-based approach to food defense rather than a checklist-based approach. This approach can be adopted with a full assessment of the facility and clearly defined process steps.

The Full Assessment Process

1. Assemble a food defense team
2. Describe the product under evaluation
3. Develop a process flow diagram
4. Describe the process steps
5. Assess risk at each step based on the “KAT” method, or based on “The Three Fundamental Elements,” or a hybrid of the two approaches.  These elements are:
   1. The severity of potential public health impact
   2. Degree of access to product
   3. Ability to successfully contaminate the product
6. Identify & implement mitigation strategies
7. Monitor mitigation strategies
8. Apply corrective actions as needed
9. Verification of the program

Concerning processing steps, the FDA has provided guidance that there are a few “key activity types” considered high risk, which they will expect food processors to focus on in their facilities. These Key Activity Types are:

• Receiving and loading of bulk liquid ingredients / raw materials
• Liquid storage and handling processes
• Secondary ingredient handling (any point where dry or liquid ingredients are handled or manipulated)
• Mixing, grinding, and similar bulk processing activities

As you can see based on the above, the FDA’s perspective is that when ingredients or products are handled and processed in bulk or are easily accessible, there is a greater risk. However, aside from these specific activities, it is each processors’ job to conduct a full assessment of all their processes and identify controls needed at any step.

The FDA does recognize that the likelihood of tampering in any single facility may be relatively low, but the potential vulnerability within the food supply as a whole did need to be addressed, and that starts with each processor taking steps to prevent issues.

How the FDA Will Enforce the Intentional Adulteration Rule

The FDA has indicated that with this rule, they will continue their focus of “educate while we regulate,” and plan to conduct only a cursory review of the company’s programs in their initial visits. These inspections will be held during other visits, such as Preventive Controls audits, rather than as a separate inspection. When conducting the audit, the auditor will likely review the company’s documented programs, without significant inspection time spent verifying all aspects of the program. Up to this point, the FDA has indicated that they plan to ask a series of basic questions about a company’s program, and also plan to provide helpful materials during the process.  After this initial inspection period, the FDA will then likely conduct more in-depth reviews of companies’ programs.

Available Guidance and Tools – Free Stuff!

There are a variety of tools that the FDA has made available for the industry. The difficulty in all these tools is sifting through all of the information they’ve provided, as it can be overwhelming. Here are a few essential items we recommend:

• The FDA has published excellent guidance on the rule and has more guidance planned in the future. Checking out the FDA’s guidance is an excellent first step for compliance with any of their regulations. We also, strongly recommend signing up for email updates about FSMA on their website.
• The FDA’s “Food Defense Plan Builder” is a piece of software that can be downloaded and used as part of building a compliant program.
• The FDA has provided a short, free training that can be taken by front-line employees to help them understand regulatory requirements and assist their company in meeting the training requirements.
• The Food Safety Preventive Controls Alliance (FSPCA) has various types of training available to assist processors in meeting the training requirements of the rule. Included in these trainings are a variety of courses, for both front-line employees and members of management involved in developing food defense programs.
• A variety of other tools like posters and suggestions for activities to test your system, are available on the FDA’s web site as well: https://www.fda.gov/food/food-defense/food-defense-tools-educational-materials
• In-Depth training for companies choosing to conduct an assessment using the “Three Fundamental Elements” analysis method, has been developed by the Food Safety Preventive controls alliance and is just now becoming available to companies. You can find more information about this training on their web site.

Interested in getting more information about the Intentional Adulteration Rule? You can reach out to a member of our team, we’d be happy to help!