The Food Safety Modernization Act (FSMA) Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) (IA Rule) regulation is intended to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm. The regulation requires covered facilities to conduct a vulnerability assessment (VA) to identify actionable process steps (21 CFR 121.130). The regulation further requires that individuals conducting or overseeing the conduct of a VA “have successfully completed training for the specific function 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” (21 CFR 121.4(c)(2)). This training developed by the Food Safety Preventive Controls Alliance (FSPCA) is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet this requirement.
This course will provide participants with the information and skills necessary to conduct a vulnerability assessment that considers the three fundamental elements outlined in the IA rule. In addition, participants will understand the IA rule's requirements generally, helpful preliminary steps, how to apply the hybrid approach, and reanalysis requirements as they relate to vulnerability assessments..
Jon Woody, CAPT, USPHS, Food and Drug Administration