Domestic Facility Risk Categorization and Risk-Based Inspection Frequencies

The FDA Food Safety Modernization Act (FSMA) created section 421 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which mandates FDA inspection frequency based on risk for domestic food facilities that are required to register under FD&C Act section 415. Specifically, section 421 mandates inspection frequencies based on a facility being identified as high-risk (HR) or non-high-risk (NHR). HR facilities must be inspected at least once in the first 5 years following enactment of FSMA and then once every 3 years. NHR facilities must be inspected at least once in the first 7 years following enactment and then once every 5 years. These inspection frequencies are a minimum and some firms may be inspected on a more frequent basis. 

FDA estimates the inventory for high-risk facilities at 22,325 and non-high-risk at 60,000.  For FY 2012, approximately 7,400 HR and 8,600 NHR facilities are planned for inspections. FDA plans to inspect HR facilities every 3 years although the new legislation provides an initial frequency mandate of inspecting each HR facility once in a 5-year period

Factors in Risk Categorization (FY 2011-13)

FSMA Identified Risk Factors*	Data Elements
Known safety risks of the food	Class 1 Recalls** Foodborne illness outbreaks
Compliance history of a facility	Inspection Classifications Facilities with significant violations Facilities with a history of non-compliance
Facility’s hazard analysis and risk-based preventive controls	Limited data
Priority under section 801(h)(1)	Applicable to foreign facilities only
Certifications for imported food	Programs not yet established
Any other criteria deemed necessary	Type of activity (establishment type) Years since last inspection

Adapted from FDA, FSMA Domestic Facility Risk Categorization (FY 2012). 

The risk categorizations are expected to evolve as FDA gathers data on the new risk-based preventive controls and certifications are developed for imported foods.  The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls will be an important factor in the future. At this time, FDA is basically determining risk in a three step process based on some of the above factors:

1. Known safety risks of the food - Whether facility packs, processes or holds a commodity that has been identified with known food safety risks; that is, food commodities associated with outbreaks and/or Class-I recalls.

2.  Years since last inspection. 

3.  Compliance history - History of significant violations or non-compliance.