FDA Industry Systems
OMB Approval Number: 0910-0502
OMB Expiration Date: 08/31/2019
See OMB Burden Statement.
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 FSMA
Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) - Revised
Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition)
Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities
FSMA Final Rule: Amendments to Registration of Food Facilities
Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition)(PDF - 171KB)
- Compliance Policy Guide - Sec. 100.250 Food Facility Registration – Human and Animal Food (PDF - 98KB)
Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide