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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 by December 12, 2003.

Statement of Need: The events of September 11, 2001, highlighted the need to enhance the security of the United States 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. Regulations are needed to implement the new statutory provisions.

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 food offered for import to be held at the port of entry until the foreign facility attempting to import the food has registered.

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

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 firms. FDA estimates that 158,618 domestic establishments and 100,000 foreign establishments covered by the statute and proposed regulation will bear a cost of approximately $8.5 million in the first year. In subsequent years, new establishments will enter the industry. FDA estimates the number of new entrants each year will be equal to 10 percent of the current number of firms, for a recurring annual cost of $850,000. FDA's costs will include labor hours, hardware, software, and mailing costs for creating and administering a database. We estimate the costs to the agency for setting up the database and registering the first year registrants to be $17.4 million. This includes four FDA FTEs, contractor development of the database, hardware, software, industry outreach, and a firewall. We estimate costs for maintaining the database and adding new establishments to be $13.8 million in the second year. Total first year costs will be $25.9 million and second year costs will be $14.7 million. All of these cost estimates are preliminary and uncertain. Benefits: These provisions will improve FDA's ability to respond to outbreaks from accidental and deliberate contamination from food and deter deliberate contamination. It is not possible to directly estimate the benefits of averting a terrorist attack, as we do not know what form an attack might take or the probability of an attack occurring. Instead, to get an idea of the cost of a food disaster, we will look at the costs of some severe, foodborne illness outbreaks.

Risks: Regulations implementing legislation to protect the health of citizens against bioterrorism would 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. These regulations will improve the ability to address credible threats of serious adverse health consequences or death to humans or animals.