Registration of Food Facilities
OMB Approval Number: 0910-0502
OMB Expiration Date: 08/31/2016
See OMB Burden Statement.
2014 Food Facility Biennial Registration Renewal
October 1, 2014 12:01am through December 31, 2014 12:59pm
Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.
Please be advised that “updating” your registration is a different function than “renewing” your registration. During the renewal period, you will not see the “Update” button listed on the FFRM main menu, until the registration is renewed. If a registration is not renewed by 11:59 PM on December 31, 2014, the registration is considered expired and will be removed from your account. If you have any further questions please contact the FURLS Helpdesk: by phone 1-800-216-7331 or 301-575-0156; or by email FURLS@fda.gov.
For system instructions, see Food Facility Registration User Guide: Biennial Registration Renewal.
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:
- Food facilities register with FDA, and
- 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:
- Created, caused, or was otherwise responsible for such reasonable probability; or
- Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.
FDA Actions on the Bioterrorism Act of 2002 Legislation
- Compliance Policy Guide Guidance for FDA Staff: Registration of Food Facilities
- Final Rule: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (70 FR 57505)
October 3, 2005
- Slide Presentation: Overview of Registration Interim Final Rule Implementing the Bioterrorism Act [ARCHIVED]
October 15, 2003
Fact Sheet on FDA's New Food Terrorism Regulation: Interim Final Rule - Registration of Food Facilities[ARCHIVED]