With the FSMA Intentional Adulteration (IA) Rule being the first of its kind, the FDA began initial in-person surveys in March 2020 with Quick Check inspections, for which the intent was to determine if the firm had a food defense plan, but not to judge the adequacy of the plan. With that having been in place for more than three years, FDA is now looking to move to the next phase in which it will conduct Food Defense Comprehensive Inspections, going beyond presence/absence to determine adequacy and implementation.
As discussed in a mid-October FDA FSMA Chat, FDA is now developing the specifics of the program and getting personnel in place, with a goal of beginning comprehensive inspections by September 2024. But because regulatory resources are limited, the inspection will initially focus on prioritized facilities. As Miguel Hernandez stated in the chat, “The food defense comprehensive inspections will be conducted on prioritized facilities that will be identified through a food defense specific analysis. So we’re going to be focusing our resources on the areas of greatest concern and those facilities where we think there is an elevated reason to be more focused on food defense inspections.”
Facilities will still be expected to have in their Food Defense Plan the five required components which were expected during the Quick Checks: the identification of actionable process steps, identification of mitigation strategies, monitoring, corrective action procedures, and verification. Additionally, the vulnerability assessment will be inspected to ensure it considers 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.
It also will need to have considered the actions of an inside attacker, that is, anyone with legitimate access (employees, contractors, maintenance personnel, etc.). “If those elements are present in the vulnerability assessment, and the CSO can determine that the vulnerability assessment has adequately and appropriately considered those elements within its analysis, we can come to a conclusion as to whether that vulnerability assessment is valid,” Hernandez explained.
A key component of the FDA inspection program will be consistency, with consistent application of the IA Rule requirements critical to ensure that the industry understands FDA expectations and that the program is not weakened by haphazard inspection. So, each food defense inspection:
- Will focus on a detailed review of the written food defense plan and inspection to determine the status of the plan implementation in the facility. From this the adequacy of the plan components will be determined and the implementation status assessed.
- Will be conducted by FDA Food Defense Inspection Team members who have received specialized food defense training. Additionally, CFSAN Food Defense SMEs will be available for real-time consultation and technical support.
The plan is to start with a small but very specialized team of Consumer Safety Officers (CSOs) who will conduct food safety inspections along with the food defense inspections while in a facility. Therefore, each site will receive two 482s upon the FDA’s on-site arrival. The approach will consist of educating while regulating. The initial team will consist of five CSOs (yet to be named) and a supervisor (Miguel Hernandez) who report up through a dedicated chain. The selected CSOs will have ample food safety expertise; be proficient in Preventive Controls but able to do any type of FDA regulated food inspection (e.g., Seafood HACCP, bottled water, infant formula, etc.); have “ample, ample, ample” experience interacting with firms to enable education while regulating; and be diplomatic. They will be located in various U.S. geographic areas, but have national responsibility, so need to like both domestic and foreign travel. “We are looking for the best of the best,” Hernandez said.
One other area of note that came up in the question section of the FDA Chat was the application to dairy farms. FSMA specifically exempted farms from IA coverage, with the exception of dairy farms, due primarily to the fact that two of the key activity types, liquid storage and handling, and bulk liquid receiving and loading, are present on dairy farms. But because dairy farms don’t have to register with FDA as food facilities under the Bioterrorism Act, FDA is working with the National Conference of Interstate Milk Shippers to identify the steps needed for food defense there.
Whether a manufacturing facility, dairy farm, or other establishment covered by the IA Rule, it is essential that you not only be solidifying your Food Defense Plan, ensuring that it have all required components, but that you also ensure its adequacy for your facility, and that it is being implemented as written. If you’ve not reviewed, refined, and implemented your plan, you may be in for a harsh surprise next year!
TAG experts have been working with facilities on their Food Defense Plans, vulnerability assessments, and Food Defense Qualified Individual training since the introduction of the IA Rule. Give us a call to assist you with yours!
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