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HHS/FDA RIN: 0910-AC40 Publication ID: Fall 2004 
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 facilities engaged in manufacturing, processing, packing, or holding of food for consumption in the United States to be registered with the Secretary. Section 415 directs the Secretary 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 the Secretary 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 information contained in the registration in a timely manner. Under the interim final rule (IFR) published on October 10, 2003 (68 FR 58894), upon receipt of the completed registration form, FDA will notify the registrant of receipt of the registration and assign a unique registration number to the facility. Section 415 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, the food will be held at the port of entry or at a secure facility, until the foreign facility has registered. On April 14, 2004, FDA issued a notice reopening for 30 days, on a limited range of issues, the comment period on the IFR. FDA took this action consistent with its statement in the IFR that it would reopen the comment period for 30 days in order to ensure that those commenting on the IFR had the benefit of FDAs outreach and educational efforts and had experience with the systems, timeframes, and data elements of the registration system. 
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.

Statement of Need: The events of September 11, 2001, highlighted the need to enhance the security of the U.S. food supply. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which was signed into law on June 12, 2002. This regulation is required by the Bioterrorism Act and is needed to implement the new statutory provision.

Summary of the Legal Basis: Section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) amends the FFDCA by adding section 415, which directs the Secretary to establish by regulation requirements for the registration of food and animal feed facilities. Section 305 amends section 301 of the FFDCA by making the failure to register in accordance with section 415 a prohibited act. Section 305 also amends section 801 of the FFDCA by requiring that food from an unregistered foreign facility that is offered for import into the United States be held at the port of entry or at a secure facility until the foreign facility has registered.

Alternatives: None, based on clear statutory directive to establish the regulation.

Anticipated Costs and Benefits: Costs: Requiring registration for domestic and foreign facilities that manufacture, process, pack, or hold food will create costs for facilities to register and for FDA to set up and administer a database of firms. Industry costs are primarily a function of the number of firms affected and the amount of labor needed to register those facilities. Foreign facilities are required to hire U.S. agents. FDA estimates that 216,721 domestic establishments and 205,405 foreign establishments covered by the statute and IFR will bear a cost of approximately $23 million and $306 million, respectively, in the first year. Annual costs will include new registration updates and fees for United States agents. For domestic facilities annual costs will be $6.9 million. For foreign facilities annual costs will be $228.8 million. FDA's costs will include labor hours, hardware, software, and mailing costs for creating and administering a database. The costs to the agency for setting up the database and registering the first year registrants are estimated to be $13.2 million. This includes four FDA FTEs, contractor development of the database, hardware, software, industry outreach, and a firewall. The costs for maintaining the database and adding new establishments are estimated to be $8 million in the second year. Total first year costs will be $342.2 million and second year costs will be $243.7 million. In the IFR, FDA requested comment on certain issues relating to the costs of the U.S. Agent requirement. Benefits: These provisions will improve FDA's ability to respond to outbreaks from accidental and deliberate contamination of food and deter deliberate contamination. It is not possible to directly estimate the benefits of averting a terrorist attack, as FDA does not know the probability of an attack occurring or the reduction in risk resulting from registration. Instead, in order to estimate the benefits of averting foodborne emergencies, the IFR evaluates the costs of some severe foodborne illness outbreaks.

Risks: Regulations implementing legislation to protect the health of citizens against bioterrorism will advance the development, organization, and enhancement of public health prevention systems and tools. The magnitude of the risks addressed by such systems and tools is at least as great as the other risk reduction efforts within HHS' jurisdiction. This will improve the ability to address credible bioterrorist threats to food for humans or animals, and other food-related public health emergencies.

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  04/14/2004  69 FR 19766 
Interim Final Rule Comment Period Reopened End  05/14/2004   
Final Rule  06/00/2005   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
Agency Contact:
Catherine Copp
Policy Advisor to the Director, 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:301 436-1589
Fax:301 436-2637
Email: catherine.copp@cfsan.fda.gov

 
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