In a recently updated Q/A section on the FDA’s FSMA web page, FDA attempts to clarify the impact of FSMA upon “High-Risk” food facilities. Essentially, FDA plans to utilize a database to identify the world’s High Risk Facilities and inspect them all every 3 years. Also FDA plans to inspect the world’s Non High-Risk facilities every 5 years. According to FDA, there are currently 22,325 domestic facilities classified as HR. That designation was arrived at by application of the following criteria:
1. The known safety risks at the facility
2. The compliance history at that facility
3. The rigor and effectiveness of the facility’s HARPC plan
4. Whether the facility meets criteria regarding intentional adulteration under FD&C 801(h)(1)
5. The facility’s certification status for imports/VQIP, FD&C 801(q)/806
6. Resource allocation criteria as determined case by case
While not every factor applies to domestic facilities, what’s notable is the database-oriented approach FDA is incorporating. On their Domestic Facility Categorization webpage, FDA states that, “The method utilized is through a software program that assesses the characteristics of each facility in the agency’s inventory. SAS® software provides data access, analysis, and reporting from the agency’s internal data systems.” In other words, FDA is attempting to use a database which requires that all of these risk factors be translated and entered… for every registered facility in the world… in order to create an alert/notification system. Certainly, one must question FDA’s ability to perform an inspection of the 22,000 domestic HR facilities in the next 5 years, not to mention the plethora of foreign facilities that would also require an inspection under FSMA. Even more seminally, however, one must question FDA’s ability to even manage such a database and extrapolate any cohesive information out of it whatsoever. Not being known for its highly rigorous (much less integrated) datasystems FDA will struggle to keep tabs on its inventory even theoretically, much less practically through inspections. Further, FDA’s numbers necessarily miss tens (if not hundreds) of thousands of facilities not currently registered because they do not appear in the document chain, such as foreign warehouses that hold foods but do not ship, sell, or perform processing or packing steps. The very thought of an inspection rate akin to the one FDA has proposed above is slightly unbelievable.
