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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), which was signed into law on June 12, 2002. The regulations will implement section 306 of the Bioterrorism Act.

Summary of the Legal Basis: Section 306 of the Bioterrorism Act amended the FFDCA by adding section 414(b), which authorizes the Secretary to establish by regulation requirements for the creation and maintenance of records. That section of the Bioterrorism Act also added section 414(a) and amended section 704(a) of the FFDCA to permit FDA to inspect records and other information under certain circumstances. In addition, section 306 of the Bioterrorism Act also amends section 301 of the Federal Food, Drug, and Cosmetic Act by making the failure to establish or maintain any record required by the new regulations, or refusal to permit access to those records or other information as required by the new regulations, a prohibited act.

Alternatives: None.

Anticipated Costs and Benefits: The records provisions will be classified as significant under Executive Order 12866 (having an annual effect on the economy of over $100 million). The recordkeeping provisions would impose a substantial cost on industry. A first estimate is that the proposed provisions will cost the food industry approximately $235 million in the first year, approximately $510 million in the second year, and approximately $220 million every year there after. The provisions will improve substantially FDA's ability to respond to outbreaks from deliberate and accidental contamination of food. FDA will use data collected by the Center for Disease Control (CDC) and FDA on past outbreaks to estimate the benefit of improved documentation in standard tracing investigations. Of the 1,344 food-borne illness outbreaks CDC identified in 1999, only 368 (27 percent) had a confirmed etiology. A host of factors contribute to the inability to identify the cause of an outbreak, but many investigations are hampered by the lack of adequate records identifying the chain of custody of foods. While, 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, FDA uses data collected by the agency on past outbreaks to estimate the benefit of the recordkeeping provisions on standard traceback investigations. Specifically we estimate the extent to which improved recordkeeping practices will facilitate faster traceback investigations.

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.