Guidance for Industry
What You Need To Know About Registration of Food Facilities Small Entity Compliance Guide
This guidance document is a restatement of the Food and Drug Administration’s (FDA’s) current requirements for registration of food facilities presented in simplified format and language. As guidance, it is not binding on either FDA or the public.
FDA has prepared this guidance to restate the legal requirements in section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Previously, this guidance restated the legal requirements of FDA’s food facility registration regulation at 21 CFR Part 1, Subpart H (21
CFR 1.225 through 1.243), implementing section 415 of the FD&C Act, as added by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This guidance also served as FDA’s Small Entity Compliance Guide (SECG) for 21 CFR Part 1, Subpart H in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). However, section 415 of the FD&C Act was amended by the FDA Food Safety Modernization Act (FSMA) in 2011. Accordingly, FDA is revising this document to provide guidance intended to help any entity comply with the requirements of section 415 of the FD&C Act, including the amendments to section 415 of the FD&C Act made by section 102 of FSMA. This document continues to serve as FDA’s SECG for 21 CFR Part 1, Subpart H.
Introduction
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from
a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.
To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring
that:
1.Food facilities register with FDA, and
2.FDA be given advance notice on shipments of imported food.
These regulations became effective on December 12, 2003.The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, 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. Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:
1. Created, caused, or was otherwise responsible for such reasonable probability; or
2. Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.
Purpose of this Guidance
This guidance was created to inform domestic and foreign food facilities about the food facility registration requirements. It contains important information that may affect your firm.
The information in this guidance also appears online at http://www.fda.gov/Food/FoodSafety/FSMA/ucm257978.htm
