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Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide

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How to Comment

You may submit either electronic or written comments regarding this guidance at any time.

Submit electronic comments to https://www.regulations.gov

Submit written comments to

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

All comments should be identified with the docket number FDA-2018-D-1468.
 

Contains Nonbinding Recommendations

May 2018

I. Introduction

This is a revision of the guidance “What You Need To Know About Registration of Food Facilities” that was issued in December 2012. We are issuing revised guidance because in the Federal Register of July 14, 2016 (81 FR 45911), we published a final rule pertaining to registration of food facilities entitled “Amendments to Registration of Food Facilities” (the final rule). The final rule amends the regulations at 21 CFR Part 1, Subpart H (21 CFR 1.225 through 1.245). The final rule became effective on September 12, 2016. This guidance reflects changes made by the final rule. We also have made editorial changes for clarity.

We have prepared this Small Entity Compliance Guide (SECG) in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document is intended to help small entities comply with the food facility registration regulations set forth in 21 CFR, Part 1, Subpart H (21 CFR 1.225 through 1.245). These regulations are binding and have the full force and effect of law.

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 FDA guidances means that something is suggested or recommended, but not required.

II. Background

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). 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.

On October 10, 2003, we issued an interim final rule (68 FR 58894) to implement section 415 of the FD&C Act. That rule established the food facility registration regulations in 21 CFR Part 1, Subpart H (21 CFR 1.225 through 1.243).  Previously, this guidance restated FDA’s food facility registration regulations.  This guidance also served as FDA’s SECG for 21 CFR Part 1, Subpart H. 

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the FD&C Act to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.  Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances.

On July 14, 2016, we published a final rule (81 FR 45912) that amended our food facility registration regulations to reflect, among other things, the FSMA amendments to section 415 of the FD&C Act.  Accordingly, FDA has revised this guidance document intended to help small entities comply with 21 CFR Part 1, Subpart H (21 CFR 1.225 through 1.245).

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 the FDA staff responsible for this guidance as listed on the title page.

Download the Guidance for Industry:
Registration of Food Facilities: What You Need to Know About the FDA Regulation;
Small Entity Compliance Guide


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

Page Last Updated: 07/03/2018
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