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Overall Description of Deadline: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 307, directs the Secretary, through FDA, to issue final regulations establishing prior notification requirements for all imported food shipment by December 12, 2003. If FDA fails to issue final regulations by this date, the statute is self-executing on this date, and requires FDA to receive prior notice of not less than 8 hours, nor more than 5 days until final regulations are issued.

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 (the Bioterrorism Act), was signed into law on June 12, 2002. The proposed regulations would implement section 307 of the Bioterrorism Act.

Summary of the Legal Basis: Section 307 of the Bioterrorism Act amended the FFDCA by adding section 801(m), which authorizes the Secretary through FDA to establish by regulation requirements for the notification to FDA prior to the entry of imported food. In addition, section 307 of the Bioterrorism Act also amends section 301 of the FFDCA by making the offering of a food for import or the importing of a food without prior notification, as required by the new regulations, a prohibited act.

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

Anticipated Costs and Benefits: The prior notification provision is an economically significant regulatory action, mainly because so many shipments are affected. For calendar year 2002, FDA estimates that about 4.7 million human and animal food and dietary supplements line items will be imported into U.S. commerce by airplane, train, vessel, and truck. For those importers who currently do not notify FDA until their actual arrival (or later) at a point of entry, this proposed rule will create a burden as it would require a change in their current methods of operation. Prior notice requirements will also create some additional burdens if FDA requires more imported articles to be held for FDA inspection. FDA costs will include the labor hours, hardware, and software costs for updating the present OASIS system. Technology costs will likely increase further if FDA has to create a stand alone system instead of working through U.S. Customs Service's ACE system to meet the statutory deadlines. FDA costs may also include hiring additional inspectors to certify the receipt of prior notice and clear the food to enter into U.S. commerce, and storing goods, if FDA has to take custody. The provisions will improve substantially FDA's ability to examine imported food for deliberate and accidental contamination. The purpose of the prior notification of imported food shipments is to allow the FDA to determine whether there is any credible evidence or information indicating that an article of food presents a threat of serious adverse health consequences or death to humans or animals, and to receive and review the prior notification, and appropriately respond. 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.

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.