FDA Releases Factors for Determining High-Risk Status for Domestic Food Facilities

Mar 13, 2012   

As we previously reported, the FDA Food Safety Modernization Act (“FSMA”) created many new obligations for both U.S. Food and Drug Administration (FDA) and the food industry. One such obligation is found in section 201 of the FSMA, “Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry.” This section requires that FDA inspect food facilities at a frequency based upon a facilitys status as either high-risk (“HR”) or non-high-risk (“NHR”). FDA has just published FDA Domestic Facility Risk Categorization for FY 2012, which sets out the criteria FDA will be using to determine whether a domestic food facility is HR or NHR.

Status as either HR or NHR will determine a food facilitys frequency of inspection by FDA. HR facilities must be inspected at least once in the first five years following enactment of the FSMA and then once every three years thereafter. NHR facilities, on the other hand, must be inspected only once in the first seven years following enactment of the FSMA and then once every five years thereafter. These are minimum guidelines and some facilities may be inspected more frequently.

In the FDA Domestic Facility Risk Categorization for FY 2012, FDA is identifying HR food facilities based on the six risk factors identified in section 421(a)(1) of the Food, Drug, and Cosmetic Act (“FDCA”), which are as follows:

  • The known safety risks of the food manufactured, processed, packed, or held at the facility;
  • The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards;
  • The rigor and effectiveness of the facilitys hazard analysis and risk-based preventive controls;
  • Whether the food manufactured, processed, packed or held at the facility meets the criteria of priority under section 801(h)(1) of the FDCA, which relates to the prioritization to detect intentional adulteration in food offered for import into the U.S.;
  • Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 801(q) (for imported foods only) or 806 (voluntary qualified importer program) of the FDCA, as appropriate; and
  • Any other criteria deemed necessary and appropriate by the FDA for purposes of allocating inspection resources.

However, for Fiscal Years (FY) 2011-13 for domestic food facilities, FDA is determining of whether a domestic food facility is HR based upon the following four factors:

  • The known safety risks of the food manufactured, processed, packed, or held at the facility. The “known safety risks” of 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. The “compliance history” of a facility is “based on inspection results for a facility from the previous five fiscal years.” Specifically, facilities with a history of non-compliance with food safety requirements, i.e., a history of three or more “Voluntary Action Indicated” (“VAI”) within the five year time period, and those facilities with food safety violations of regulatory significance, i.e., one or more “Official Action Indicated” (“OAI”) in the five year time period, will be categorized as an HR facility.
  • The type of establishment and type of activity conducted at the facility (e.g., manufacture/processor, repacker/packer, etc.)
  • The number of years since the last inspection.

The last two factors have been identified as “other criteria deemed necessary and appropriate” for purposes of allocating inspection resources.

As FDA implements the FSMA and gathers more information, FDA will most likely need to make modifications and adjustments for FY 2014. At this time, food facilities should begin to evaluate any known safety risks associated with the food they manufacture, process, pack or hold and understand whether they are likely to be categorized as HR or NHR.

Please contact us at (305) 350-5690 or contact@fidjlaw.com to learn more about how FDA may categorize your food facility or if you have any questions regarding FSMA.