Food

Draft Guidance for Industry: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)

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How to Comment

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 14, 2016.

Submit electronic comments on http://www.regulations.gov to docket number FDA-2016-D-1164.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2016-D-1164.

Questions?

For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1700. For questions regarding this draft document as it relates to animal food, contact the Center for Veterinary Medicine (CVM) at 240-402-6246.

May, 2016  

Contains Nonbinding Recommendations

Draft-Not for Implementation

This guidance is being distributed for comment purposes only. 

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 guidance explains how to determine whether your business meets the definition of “qualified facility” under the Preventive Controls for Human Food Rule and how to submit Form FDA 3942a attesting to its status as a qualified facility under the Preventive Controls for Human Food Rule.

Section III of this guidance explains how to determine whether your business meets the definition of “qualified facility” under the Preventive Controls for Animal Food Rule and how to submit Form FDA 3942b attesting to its status as a qualified facility under the Preventive Controls for Animal Food Rule. 

Download the Draft Guidance for Industry:
Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or
Form FDA 3942b (for Animal Food) (PDF: 189KB)

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition in cooperation with the Office of Surveillance and Compliance in the Center for Veterinary Medicine at the U.S. Food and Drug Administration.

 

Page Last Updated: 11/01/2016
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