Sunday, March 18, 2012

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

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.

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