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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.