FDA Issues Draft Guidance for Qualified Facilities under the FSMA Preventive Controls Rules
May 13, 2016
The U.S. Food and Drug Administration (FDA) announced today the publication of draft guidance to assist qualified facilities, such as very small businesses, in complying with the Preventive Controls for Human Food Rule or the Preventive Controls for Animal Food Rule under the FDA Food Safety Modernization Act (FSMA).
A business that meets the definition of a “qualified facility” is subject to modified requirements of the preventive controls rules. These modified requirements can be met by submitting a form to FDA, attesting to the business’s status as a qualified facility and attesting that the facility is implementing preventive controls to address hazards associated with its food or is in compliance with non-Federal food safety laws and regulations. This draft guidance, “Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food) ” explains how to determine whether a business meets the definition of “qualified facility” and how to submit the FDA form attesting to its status as a qualified facility.
The draft guidance will be available for public comment for 180 days starting May 16, 2016. The FDA will consider all comments before completing a final version.
For more information:
- Federal Register Notice
- Draft Guidance for Industry: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)
- Draft Instructions for Submitting Your Attestation: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)
- Preventive Controls for Human Food final rule
- Preventive Controls for Animal Food final rule
- Draft Form FDA 3942a
- Draft Form FDA 3942b