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HHS/FDA

RIN: 0910-AC40

Publication ID: Fall 2003

Title: Registration of Food and Animal Feed Facilities
Abstract: This rulemaking is one of a number of actions being taken to improve FDA's ability to respond to threats of bioterrorism and other foodborne illness emergencies. Section 415 of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), directs the Secretary to require any facility engaged in manufacturing, processing, packing, or holding of food for consumption by humans or animals in the United States to be registered with the Secretary through FDA. Section 415 directs the Secretary, through FDA, to promulgate final regulations implementing the requirements by December 12, 2003. The owner, operator, or agent in charge of the facility must submit the registration. Foreign facilities must include the name of the United States agent for the facility. The registration must include the name and address of each facility at which, and all trade names under which, the registrant conducts business. If FDA determines it is necessary through guidance, the registration must include the general food category (as identified under 21 CFR 170.3) of foods manufactured, processed, packed, or held at the facility. The registrant is required to notify the Secretary of changes to the registration in a timely manner. Under the proposed rule, upon receipt of the completed registration form, FDA would notify the registrant of receipt of the registration and assign a unique registration number to the facility. The Bioterrorism Act requires the Secretary to compile and maintain an up-to-date list of registered facilities. This list and any registration documents submitted to the Secretary are not subject to disclosure under the Freedom of Information Act. For purposes of section 415, "facility" includes any factory, warehouse, or establishment engaged in the manufacturing, processing, packing, or holding of food. Exempt from the registration requirement are farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer, and fishing vessels (except those engaged in processing as defined in 21 CFR 123.3(k)). Foreign facilities required to register include only those from which food is exported to the United States without further processing or packaging outside the United States. The Bioterrorism Act provides that if food from an unregistered foreign facility is offered for import into the United States without having registered, the food will be held at the port of entry or at a secure facility, until the foreign facility has registered.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Final Rule Stage
Major: Yes	Unfunded Mandates: Private Sector
CFR Citation: 21 CFR 1
Legal Authority: PL 107-188, sec 305

Legal Deadline:

Action	Source	Description	Date
Final	Statutory		12/12/2003

Overall Description of Deadline: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 305, directs the Secretary, through FDA, to issue a final regulation establishing registration requirements by December 12, 2003. The statute is self-implementing on this date if FDA does not issue a final regulation that is effective by December 12, 2003.

Timetable:

Action	Date	FR Cite
NPRM	02/03/2003	68 FR 5377
Interim Final Rule	10/10/2003	68 FR 58894
Interim Final Rule Comment Period Reopened	03/00/2004

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
Agency Contact: Leslye M. Fraser Associate Director for Regulations, Office of Regulations and Policy Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone:301 436-2378 Fax:301 436-2637 Email: leslye.fraser@cfsan.fda.gov