Is my operation a “qualified facility” under FDA’s preventive controls rules?
Story Date: 9/24/2018

 

Source: NATIONAL SUSTAINABLE AGRICULTURE COALITION, 9/21/18

Are you a small food business owner interested in a partial exemption from some of the new Food Safety Modernization Act (FSMA) rules? Under the Preventive Controls Rules for Human and Animal Food, a “qualified facility” is exempt from the Hazard Analysis and Risk-based Preventive Controls (HARPC) and the Supply Chain Program requirements. Recently, the Food and Drug Administration (FDA) finalized the attestation forms that allow businesses to confirm their status as a qualified facility.


Businesses interested in confirming their qualified facility status should note the upcoming deadline for submitting an attestation form.


FDA also released two related documents: Instructions for filling out the attestation forms and final guidance for the Determination of Status as a Qualified Facility (“Qualified Facility Guidance”). These documents provide additional information for businesses who are unsure about whether or not they are a qualified facility.

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