FDA Releases Information for Qualified Facilities under Preventive Controls Rules

Constituent Update

September 14, 2018

Today, the U.S. Food and Drug Administration 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. (However, the facilities remain subject to current good manufacturing practice requirements.)

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.

Under each rule, qualified facilities are exempt from the hazard analysis and risk-based preventive controls requirements, and instead are subject to modified requirements. These requirements 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 today along with instructions on how to fill them out and how they should be submitted. In addition, starting October 1, facilities will be able to submit these attestation forms electronically at https://www.access.fda.gov/ via the Qualified Facility Attestation Module. Please note that facilities must first create or have an existing FURLS account to access the module. Also, facilities must have a valid food facility registration to submit their attestation.

Facilities subject to the PC Human Food rule must submit their first attestation to FDA by December 17, 2018, if they began manufacturing, processing, packing, or holding food before September 17, 2018. Facilities subject to the PC Animal Food rule must submit their first attestation by December 16, 2019, if they began manufacturing, processing, packing, or holding animal food before September 17, 2019. Beginning in 2020, attestation forms will need to be submitted during the food facility biennial registration renewal period that begins on October 1 and ends on December 31.

Additional Information

• Guidance for Industry: Determination of Status as a Qualified Facility
• Federal Register Notice announcing the guidance
• Instructions for Submitting Qualified Facility Attestation
• Qualified Facility Attestation
• Form FDA 3942a (Human Food)
• Form FDA 3942b (Animal Food)
• Preventive Controls for Human Food Rule
• Preventive Controls for Animal Food Rule