Are you ready for compliance with Intentional Adulteration Rule?

Food Safety Modernization Act consists of 7 Rules. The most recent FSMA regulation is Mitigation Strategies for Protecting Food Against Intentional Adulteration (21 CFR 121).

Compliance dates for large medium and small business were in July 2019 and July 2020, respectively.

Very small businesses still have the time until July of 2021 to comply with IA requirements. Intentional Adulteration Rule requires that each business that holds, pack, processes or manufactures food conducts vulnerability assessment that contains the 3 elements: (1) The potential public health impact (e.g., severity and scale) if a contaminant were added; (2) The degree of physical access to the product; and (3) The ability of an attacker to successfully contaminate the product.

Based on the assessment facilities must identify Actionable Process Steps – APS – (where appropriate) and mitigation strategies for APSs. According to the regulation mitigation strategies must include management components such as monitoring, corrective actions, verification, and recordkeeping procedures. This means the food defense plans must be constructed by using HACCP method.

Guidance document to Intentional Adulteration rule recommends that facilities conduct preliminary steps in development of their food defense plans. These steps are consistent with preliminary steps taken in food safety plans development and include assembling food defense team, product description, development of a flow chart with processing steps and process description.

Facilities have a choice of the method for conducting vulnerability assessment as long as it includes the 3 mentioned components. FDA came up with a method that could be used in the VA, it is called Key Activity Types (KAT). Instead of assessing each of the 3 elements separately, a company may use KAT method to save time and effort.

KAT method was developed based on prior vulnerability assessments conducted in facilities processing variety of food product categories. The results were similar despite the differences in food products being made. KAT method identifies activities that would always come up as significant vulnerabilities regardless of the type of food being produced / processed and include the following activities: bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing and similar activities.

All activities must be conducted by Food Defense Qualified Individual which is different than Preventive Controls Qualified Individual or Qualified Individual according to definitions in other parts of FSMA. Food Defense Qualified Individual is an individual must meet the following requirements: 1) Education, training, or experience (or a combination thereof) necessary to properly perform the activities; and 2) Successful completion of training for the specific function that is at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities. Job experience may also qualify you as FDQI but only if it provided you with the knowledge that is equivalent to that received after completing training according to standardized curriculum recognized by FDA (i.e., FSPCA’s curriculum).

We recognize that some of the smaller businesses may not have sufficient resources to complete the tasks required by IA regulation. BD Food Safety Consultants LLC can assist in this process. Contact us for more information or to schedule an appointment.