Mitigation Strategy to Protect Food Against Intentional Adulteration (21 CFR 121) is one of the most important rules under Food Safety Modernization Act. This requirement brings a new approach in how we look at food defense and food security. The old approach focused on site security and ensuring that our operation is protected from an outside attacker that could potentially enter the building and contaminate the food. With the new concept the sites must consider an inside attacker as a viable threat. Based on years of assessments and collaboration with other governmental agencies the FDA determined that the highest risk and the potential to successfully contaminate the food is related to the people with legit access to food facilities. Employees, contractors and visitors that are familiar with the operation and habits within the company have the highest chances to conduct a successful attack.
Under the IA Rule a company that manufactures, processes, repacks or holds food must conduct vulnerability assessment to identify significant vulnerabilities. For those significant vulnerabilities the company would need to establish an Actionable Process Step(s) (APS)
with mitigation strategies to avoid affecting the public on a large scale. FDA under the IA rule requires that all activities are conducted by a Food Defense Qualified Individual(s). Sounds familiar?
FDA wants the FDQI(s) to use HACCP method in developing a risk-based Food Defense Plan. A vulnerability assessment is equivalent to hazard analysis, APS would correspond to a CCP, and mitigation strategies have the same management components as CCPs. This includes the monitoring, corrective actions, verification procedures and records.
To become FDQI the definition included in the regulation requires successful completion of training in the development and implementation of risk-based food defense plans. The training must be according to a standardized curriculum recognized by the FDA as adequate. FSPCA’s 1 Day curriculum is the only one that meets those criteria.
Unlike in other FSMA rules, the training for qualified individuals under IA Rule was split into several sessions. Some of you are probably PCQI(s) and needed to attend 2.5 days training to earn the title. Here, there is only one instructor led course that lasts one day (7 hours contact time) and there are two additional self-paced courses a few hours long each.
he instructor led course is for conducting the vulnerability assessment as this is the starting point of the risk-based food defense plan. It is called Intentional Adulteration Vulnerability Assessment Training or IAVA Training. In this training the participants learn about the three fundamental elements that must be considered in the vulnerability assessment. Element 1 – The scale of public health impact, Element 2 – Physical access to the product and Element 3 – The ability to successfully contaminate the product. Each of the 3 elements are scored and sum of scores is one of the factors considered in the decision-making process. FDQI will decide which process steps pose significant vulnerabilities and require an actionable process step (APS) with mitigation strategies. The other two courses for mitigation strategies and preparation of the food defense plan are available on FSPCA’s website.
Without the IAVA Training conducting an adequate assessment might be challenging. FDA has extended the enforcement times due to pandemic and other factors, but the full-scale Food Defense compliance inspections are scheduled to start in mid-2025. Keep in mind that one of the first questions you will be asked by an investigator will be about the FDQI. Here are BD Food Safety Consultants LLC we offer the FSPCA’s 1 Day IAVA Training. To learn more
The instructor led course is for conducting the vulnerability assessment as this is the starting point of the risk-based food defense plan. It is called Intentional Adulteration Vulnerability Assessment Training or IAVA Training. In this training the participants learn more visit us at https://bdfoodsafety.com/iava-training/