Is Yours A High-Risk Food Facility? Now You Know

March 12, 2012

By Ricardo Carvajal

FDA published its Food Safety Modernization Act ("FSMA") Domestic Facility Risk Categorization for FY2012, which distinguishes domestic high-risk ("HR") food facilities from non-high-risk (NHR) food facilities for purposes of determining frequency of inspection.  For now, the determination of whether a facility is HR will depend primarily on four factors.  FDA will consider:

  • “The known safety risks of the food manufactured, processed, packed, or held at the facility,” as determined by Class I recalls and outbreaks of foodborne illness.  “Known safety risks” of a food “are based on broad, industry-level food commodity categories, e.g., bakery, leafy vegetables, spices.” 
  • “The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.”  This will be determined by the type and number of prior inspection classifications in the previous five fiscal years (i.e., a single classification as “Official Action Indicated,” or three or more classifications as “Voluntary Action Indicated”).
  • The type of establishment and type of activity at the facility (e.g., manufacturing, packing, storage).
  • The number of years since the last inspection. 

As FSMA implementation progresses, other factors will come into the mix (e.g., “the rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls”).  Facilities would do well to review the Risk Categorization to determine whether they are likely to be categorized as HR, and therefore can expect to see FDA inspectors with greater frequency.