Qualified Facility

According to Title 21 CFR 117, Qualified Facilities are very small businesses that meet the following definition.

A very small business, any subsidiaries, and its affiliates, qualify for these modified requirements if:

• the business averages less than $1 million, adjusted for inflation, per year, during the last three years in sales.
  
  OR

• over the last three years the average annual monetary value of food sold directly to the end-user exceeded the average annual monetary value of food sold to other purchasers. And the average annual monetary value of food sold over three years was less than $500,000, adjusted for inflation.

Any businesses that meet this definition can submit a Qualified Facility Attestation. Completing the attestation would modify the requirements for a hazard analysis and risk-based preventive controls.

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