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FDA Publishes Criteria for "High Risk" Facilities

Date: Mar 13, 2012

On March 9, 2012, the Food and Drug Administration (FDA) published on its website "FSMA Domestic Facility Risk Categorization (FY 2012)," identifying the criteria FDA uses when categorizing "high risk" domestic facilities that are subject to more frequent FDA inspections, as required by Section 201 of the FDA Food Safety Modernization Act (FSMA), available here. Section 201 of FSMA (adding Section 421 to the Federal Food, Drug and Cosmetic Act) requires high risk facilities to be inspected at least once in the first 5 years following enactment of FSMA and then once every 3 years thereafter. Non-high risk facilities must be inspected at least once in the first 7 years following enactment and then once every 5 years thereafter.

Section 201 established the primary factors for FDA to use in the characterization of high risk facilities. This new webpage identifies the specific data that FDA is using to categorize facilities.

FSMA Risk Factor: Known safety risks of the food manufactured, processed, packed, or held at the facility.

  • Data Elements:
    • Class 1 recalls;
    • Outbreaks.
  • If both data elements are met, the facility is categorized as high risk.
  • If one of the data elements are met AND the facility has not been inspected within the previous five fiscal years, the facility is categorized as high risk.
  • Based on industry-level commodity categories, such as bakery, leafy vegetables, and spices.

FSMA Risk Factor: Compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.

  • Data Elements:
    • Facilities with significant violations (as shown by issuance of an "Official Action Indicated");
    • Facilities with a history of noncompliance (as shown by having received 3 or more "Voluntary Action Indicated").
  • Based on inspection results from the previous five fiscal years.
  • If both data elements have been met within the previous five fiscal years, the facility is categorized as high risk.

FSMA Risk Factor: The rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls.

There is no data at this time to characterize this risk factor, but data will be incorporated as the Hazard Analysis and Risk-Based Preventive Controls regulations (Section 103 of FSMA) go into effect.

FSMA Risk Factor: Whether the food manufactured, processed, packed or held at the facility meets the criteria for priority under section 801(h)(1) of the FD&C Act.

  • This risk factor is not applicable to domestic facilities.

FSMA Risk Factor: Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 801(q) (certification for imported food) or 806 (voluntary qualified importer program) of the FD&C Act, as appropriate

  • These programs have not yet been established.

FSMA Risk Factor: Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources

  • Data Elements:
    • Type of activity (establishment type, i.e., manufacturer/processor, repacker/packer, etc.);
    • Years since last inspection.

For Fiscal Years 2011-2013, FDA is using the first, second, and third criteria to categorize domestic facilities. FDA has categorized 22,325 facilities out of a total of 82,300 domestic facilities as high risk, and has the goal of inspecting these facilities within a 3-year cycle (2011-2013). These criteria will change and evolve as the implementation of FSMA continues and FDA develops better data.

For more information, please contact Deborah C. Attwood (+1 202.434.4107, attwood@khlaw.com) or Mel S. Drozen (+1 202.434.4222, drozen@khlaw.com).