Food

Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration

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How to Comment

Submit either electronic or written comments on the draft guidance by October 19, 2018.

Submit Comments Online
Submit electronic comments on http://www.regulations.gov to docket folder FDA-2012-D-1002 starting August 20, 2018.

Submit Written Comments
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-2012-D-1002.

Questions?

For questions regarding this document contact FDA’s Technical Assistance Network by submitting the inquiry form.

Contains Nonbinding Recommendations 

Draft– Not for Implementation

This guidance is being distributed for comment purposes only.

August 2018

On October 10, 2003, the Food and Drug Administration (FDA or we) issued an interim final rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) (68 FR 58894). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. This guidance was developed to answer frequently asked questions relating to the registration requirements of section 415 of the FD&C Act.

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended the food facility registration requirements in section 415 of the FD&C Act.

FDA first issued a guidance document with questions and answers regarding food facility registration requirements on December 4, 2003. That guidance was issued as Level 2 guidance pursuant to Title 21, Code of Federal Regulations (CFR), Section 10.115 (21 CFR 10.115). The most recent edition of the guidance (the Seventh Edition) was issued as Level 1 guidance pursuant to 21 CFR 10.115 in August, 2018, and includes updated questions and answers relating to food facility registration.

We are issuing these supplemental questions and answers as draft guidance pursuant to 21 CFR 10.115. We are issuing this supplement because FDA continues to receive questions that highlight the need to provide guidance on registration requirements in situations where multiple entities are involved in the use of shared physical space, such as where one entity owns a building and lessees manufacture/process, pack or hold food in the building. FDA has drafted several questions and answers to clarify our thinking about who should register in these situations. We intend to finalize this guidance by incorporating these questions and answers into a future edition of the Questions and Answers Regarding Food Facility Registration: Guidance for Industry.

“I”, “you,” “your” or “registrant” are used in this guidance to refer to the owner, operator, or agent in charge of a facility that manufacturers/processes, packs, or holds food for consumption in the United States.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.  

Download the Draft Supplemental Guidance 

Page Last Updated: 09/19/2018
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