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Is Your Business a Qualified Facility Under Preventive Controls Rules?

FDA Issues New Resource Materials

The U.S. Food and Drug Administration has issued documents designed to help food facilities subject to the preventive controls for human and animal food rules determine if they meet the definition of a “qualified facility” under those rules, and if so, what modified requirements are applicable to such facilities. A qualified facility is generally a business that, because of its very small size, is required to meet only modified requirements under the FDA Food Safety Modernization Act. 

The first document is a guidance to help food facilities determine whether they meet the definition of a qualified facility under one of two FSMA rules: the Preventive Controls for Human Food (PC Human Food) or Preventive Controls for Animal Food (PC Animal Food) Rules. Modified requirements for such facilities include the submission of a form to attest to the facility’s status as a qualified facility, and attest that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations.

The required attestation forms, Form FDA 3942a for facilities subject to the PC Human Food rule, and Form FDA 3942b for facilities subject to the PC Animal Food Rule, are also being released along with instructions on how to fill them out and how they should be submitted.

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