Food

Draft Instructions for Submitting Your Attestation: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)

Resources

May 2016

Introduction

The FDA Food Safety Modernization Act establishes requirements for hazard analysis and risk-based preventive controls for facilities that produce food for humans and animals. We have established regulations to implement these requirements within subparts C and G of our regulations entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (21 CFR part 117) (the Preventive Controls for Human Food Rule) and within subparts C and E of our regulations entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (21 CFR part 507) (the Preventive Controls for Animal Food Rule).

A business that meets the definition of a “qualified facility” is subject to modified requirements in § 117.201 of the Preventive Controls for Human Food Rule or in § 507.7 of the Preventive Controls for Animal Food Rule. These modified requirements require the business to submit a form to FDA, attesting to its status as a qualified facility. Section II of this document explains how to submit Form FDA 3942a attesting to your business’s status as a qualified facility under the Preventive Controls for Human Food Rule. Section III of this document explains how to submit Form FDA 3942b attesting to your business’s status as a qualified facility under the Preventive Controls for Animal Food Rule.

Download the complete Draft Instructions for Industry: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food) (PDF: 92KB.

Page Last Updated: 10/31/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English