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FDA Industry Systems Login / Create Account OMB Approval Number: 0910-0502 OMB Expiration Date: 08/31/2016 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:

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:

FDA Actions on the FSMA

FSMA Final Rule: Amendments to Registration of Food Facilities

July 2016

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

November 2014

Compliance Policy Guide - Sec. 100.250 Food Facility Registration – Human and Animal Food (PDF - 98KB)

June 2014

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

December 2012

Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories

October 2012

FDA Actions on the Bioterrorism Act of 2002 Legislation

Compliance Policy Guide Guidance for FDA Staff: Registration of Food Facilities

August 2006

Final Rule: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (70 FR 57505)

October 2005

Guides and Tutorials

Food Facility Account Management

User Guides for Online Registration of Food Facilities

Guide to Biennial Registration Renewal

Cancellation by Paper (Mail or FAX) or CD-ROM

System Status

Additional Resources

Registration Statistics

Contact FDA

1-800-216-7331

301-575-0156 furls@fda.gov

FDA Industry Systems

Help Desk

(Technical, Computer & General Questions)

Help desk hours are Monday to Friday from 7:30 am to 11:00 pm Eastern Standard Time

More in Food Facility Registration

Online Registration of Food Facilities

Acidified & Low-Acid Canned Foods (LACF) Registration

New Dietary Ingredients Notifications (NDI)

Qualified Facility Attestation

Shell Egg Producer Registration

Structure/Function Claims Process

Page Last Updated: 07/13/2016

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