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FDA Issues Draft Guidance for Qualified Facilities Under the FSMA Preventive Controls Rules

Friday, May 20, 2016

(North American Meat Institute)

The Food and Drug Administration (FDA) published draft guidance to assist qualified facilities, such as very small businesses, in complying with the Preventive Controls for Human Food and Preventive Controls for Animal Food final rules under the Food Safety Modernization Act (FSMA). This draft guidance, " Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food) ," details methods to determine whether a business meets the definition of "qualified facility" and provides instructions to assist an establishment in confirming its status as a qualified facility.

A business meeting 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 proving that the facility is implementing preventive controls to address hazards associated with its food. The establishment can also verify that it is in compliance with non-federal food safety laws and regulations. The draft guidance will be available for public comment for 180 days starting May 16, 2016. Comments may be submitted either electronically or by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852.

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