October 15, 2019

FDA Categorizes Food Facility Risks

Last week the FDA released information on the categorization of food facilities as high risk (HR) or non-high risk (NHR). This data will be used to determine how often the facilities are inspected under the Food Safety Modernization Act (FSMA).

All facilities will be inspected once in the first five years after FSMA enactment, to establish a baseline, then once every three years. NHR facilities must be inspected once in the first seven years after FSMA enactment, then once every five years.

Six different factors are used to determine the risk categorization. They are:

  • If the facility produces known risky foods, such as sprouts, leafy greens, spices, or eggs.
  • The facility’s compliance history, including recalls, foodborne illness outbreaks, and violations of food safety standards.
  • The rigor of the establishment’s food safety plan, including hazard analysis and risk-based prevention controls.
  • If the facility has high-risk imported foods that may be subject to intentional adulteration.
  • If the facility is certified under the voluntary qualified importer program.
  • Any other criteria deemed necessary and appropriate, such as the number of years since the last inspection and the type of establishment (warehouse vs. processing facility).

Factors 3 and 5 can’t be applied yet, since they have not been fully developed. And factor 4 applies only to foreign facilities.

Here is the text flow chart for the categorization process:

Step 1: Determine if facility is required to register under Sec 415 Requirements. (FY12 based on data from agency’s Official Establishment Invenotry. Resources are allocated for facilities not required to register.)
If no, Section 421 (a) requirements do not apply.
If yes, move to step 2.

Step 2: Determine if the facility packs, processes or holds a commodity that has been identified with known food safety risks. Know food safety risks are currently considered to be food commodities that are associated with Outbreaks and Class 1 Recalls.
If yes, move to step 2a.
If no, move to Step 3 Compliance History.

Step 2a: Determine if the facility is a manufacturer of a food commodity category associated with outbreaks AND class I recalls within previous 5 fiscal years. Or alternatively, a manufacturer or a food commodity category associated with outbreaks OR class I recalls and NOT inspected within the previous 5 years.
If yes, the facility is considered to be a High-Risk facility and will be inspected a minimum of once within a 3-year cycle.
If no proceed to Step 3 Compliance History.

Step 3: Consider the compliance history of a facility. Determine if a facility has received an inspection classification of “Official Action Indicated” (OAI) in the previous 5 fiscal years. Or alternatively, three (3) inspections classified as “Voluntary Action Indicated” (VAI) in the previous 5 fiscal years.
If yes, the facility is considered to be a High-Risk facility and will be inspected a minimum of once within a 3-year cycle.
If no, the facility is considered to be a Non-High Risk facility and will be inspected a minimum of once within a 7-year period.

Modifications to this plan will take place in fiscal year 2014 or as needed. The FDA can inspect facilities more often than the mandate requires if a follow-up to check on violations is needed or as a result of emerging public health information.

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