FDA Draft Guidance for Qualified Facilities

The U.S. FDA publishes a draft guidance to assist qualified facilities, such as very small businesses, in complying with the Preventive Controls for Human Food Rule or the Preventive Controls for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 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’ 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 This draft guidance, “Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food) ” explains how to determine whether a business meets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. Draft guidance is currently available for public comment at https://federalregister.gov/a/2016-11439.