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Food Safety Modernization Act (FSMA) (FY 2012)

March 26, 2012

How Does FDA Identify a High-Risk (HR) Facility?

The agency is utilizing a decision-making process based on the risk factors identified in section 421(a)(1) of the FD&C Act, which are:

  1. The known safety risks of the food manufactured, processed, packed, or held at the facility;

  2. The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards;

  3. The rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls;

  4. 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, which relates to the prioritization to detect intentional adulteration in food offered for import into the U.S.;

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

  6. Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

For the FY 2011-13 planning cycle for domestic facilities, the decision-making process is based primarily on the first two factors listed, as well as certain additional criteria identified as part of the sixth factor. There are not data available at this time to characterize the third factor for all industry types. It will be incorporated as the Preventive Controls regulation and the data collection develop. The fourth factor applies only to foreign facilities. While the fifth factor may apply to some domestic facilities, the relevant certification programs have not yet been established.

Two additional factors that have been identified pursuant to the sixth item are: establishment type / type of activity conducted at the facility (manufacturer/processor, repacker/packer, etc.) and years since last inspection.

The method utilized is through a software program that assesses the characteristics of each facility in the agency's inventory. SAS® software provides data access, analysis, and reporting from the agency's internal data systems. The current model is best depicted with a decision tree as shown in Diagram 1 resulting in facilities being categorized as HR or NHR.

Identification of HR facilities is based on the known safety risks of foods at the industry-wide level and compliance history, which is firm specific.

  • The “known safety risks” of food are based on broad, industry-level food commodity categories, e.g., bakery, leafy vegetables, spices. If a facility manufactures food commodity categories associated with foodborne outbreaks AND class I recalls, then they are placed in the HR facility category. If a facility manufactures food commodities associated with foodborne outbreaks OR class I recalls and they have not been inspected within the previous five fiscal years, then they are placed in the HR facility category.

  • The facility-specific factor of “compliance history” is based on inspection results for a facility from the previous five fiscal years. Facilities with a history of non-compliance with food safety requirements (a history of three or more VAI within the five year time period) and those with food safety violations of regulatory significance (one or more OAI in the five year time period) are placed in the HR facility category.