Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)

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How to Comment
You may submit electronic or written comments regarding this guidance at any time starting August 20, 2018.

Submit Written Comments
Division of Dockets Management (HFA-305)
Food and Drug Administration
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Submit Comments Online
Submit electronic comments on http://www.regulations.gov to docket folder FDA-2012-D-1002

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

Contains Nonbinding Recommendations

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.

The first edition of this document was issued as Level 2 guidance pursuant to Title 21, Code of Federal Regulations (CFR), Section 10.115 (21 CFR 10.115) and was made available on FDA's website on December 4, 2003. The second, third, fourth, and fifth editions of this document were issued as Level 1 guidance documents pursuant to 21 CFR 10.115 and were made available on FDA’s website on January 12, 2004, February 17, 2004, August 2004, and December 2012, respectively. The sixth edition was issued as Level 1 guidance and included one additional question and answer relating to a proposed change to the “farm” definition in 21 CFR 1.227 (79 FR 58524; September 29, 2014). The new question and answer was identified with the date that it was added to the guidance. The sixth edition was immediately effective because FDA had determined that prior public participation was not feasible or appropriate.

This revision (Seventh Edition) is being issued as Level 1 guidance pursuant to 21 CFR
10.115 and includes additional questions and answers relating to issues regarding food facility registration, including issues related to the following rulemakings: the Amendments to Registration of Food Facilities final rule (Registration Final Rule) (81 FR 45912; July 14, 2016) that revised FDA’s registration regulation; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (80 FR 55907; Sept. 17, 2015); and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (80 FR 56170; Sept. 17, 2015). We also revised information in existing questions and answers, deleted some questions and answers, and made editorial changes (e.g., reorganized existing questions and answers) to improve clarity.

“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.

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This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact FDA’s Technical Assistance Network by submitting your information.