Picture this: It’s Monday morning. You’ve had a great weekend, the weather was beautiful, and you got the yardwork done in time to watch the game. So, you sit down at your desk, ready to set the week’s plans in motion. Then you get a call from the front desk: An FDA inspector has arrived, and he wants to see your food defense plan and how you’ve applied it in the plant.
What is your reaction?
Since March 2020, FDA has been conducting “quick check” inspections against FSMA’s Intentional Adulteration (IA) Rule. In November 2023, TAG informed readers that FDA would begin conducting full, comprehensive inspections by September 2024.
It is now September 2024, and FDA is, indeed, conducting comprehensive IA inspections.
In fact, the inspections began in August, are unannounced, and include inspection to other rules to which the facility is subject. While FDA has not disclosed the specifics by which it is prioritizing facilities for inspections, it is being based on food defense consideration of areas of greatest importance, based on a 43-element “matrix” (the elements of which it is not disclosing). FDA has stated, however, that a facility citation for poor food safety compliance, such as a poor food safety plan; issuance of a 483 in a past inspection; or implication in a recall would weigh heavily on the matrix.
While the inspector will inspect both the Food Safety Plan and Food Defense Plan and their implementation, the food safety and food defense inspections will be considered as separate, with a 482 Notice of Inspection for each, and the possibility of being issued two separate 483s, should they be warranted.
Inspections are being conducted by members of the FDA’s Food Defense Inspection Team (FDIT). Initially consisting of a core group of five inspectors, with one supervisor, the current plan is that the team will expand to 15 investigators. FDIT inspectors have extensive food safety and food defense expertise, with practical experience in food safety assessments in all types of food manufacturing; they also are selected for their ability to be diplomatic and educate while they regulate. At this point, there are not expected to be any state food defense inspectors. The inspector will focus on a detailed review of the written food defense plan and a facility inspection to determine its adequacy, appropriateness, and implementation.
The IA Rule requires that a food facility have and implement a written Food Defense Plan (FDP), a key aspect of which is the identification of actionable process steps (APS) defined by FDA as “a point, step, or procedure in a food process where a significant vulnerability exists and at which mitigation strategies can be applied and are essential to significantly minimize or prevent the significant vulnerability.” Thus, the inspection, and any enforcement, will concentrate on proper APS identification, mitigation strategy implementation, verification/corrective action, and related documentation.
To fulfill the requirements of the IA Rule, the FDP is also required to be written and implemented by a Food Defense Qualified Individual (FDQI), and it must include a vulnerability assessment, considering the three fundamental elements at each process step: level of public health impact, degree of physical access, and ease of introducing a contaminant that would result in wide-scale public health harm.
Three primary methods by which a vulnerability assessment can be conducted are the Key Activity Types (KAT) method, the Three Fundamental Elements approach, or the Hybrid method. With four FSPCA IAVA Lead Instructors, TAG regularly conducts courses in all three methods, with registration currently available for:
- IAVA KAT and Mitigation Training, Nov. 11, 2024
- Three Fundamental Elements approach, Nov. 12-13, 2024
- Writing the Food Defense Plan with Management Components, Nov 13, 2024
For more information, visit TAG’s Virtual IA VA Training for registration; visit TAG’s Food Defense Service; or contact us.
All content in TAG articles, newsletters, and webpages are developed and written by TAG experts, not AI. We focus on the realities and the science to bring you the most current, exacting information possible.
