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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 (Pub. L. 107-188), which was signed into law on June 12, 2002. The proposed regulation would implement section 303 of the Bioterrorism Act.

Summary of the Legal Basis: The Bioterrorism Act, section 303, amended the Federal Food, Drug, and Cosmetic Act (FFDCA) by adding section 304(h) (21 U.S.C. 334(h)), which authorizes the Secretary to order the detention of domestic and imported food and specifies an appeals process that includes an opportunity for an informal hearing. Section 303 of the Bioterrorism Act also amends section 301 of the FFDCA (21 U.S.C. 331) by making it a prohibited act to transfer an article of food in violation of a detention order or to remove or alter any required mark or label identifying the article as detained.

Alternatives: FDA's decision to promulgate a regulation is based primarily on clear statutory directive to establish regulations, and also on need. The Bioterrorism Act, section 303, clearly states that the Secretary must provide by regulation for procedures for instituting enforcement actions with respect to perishable foods on an expedited basis. Section 303 of the Bioterrorism Act also specifies an appeals process that requires the Secretary, after providing for opportunity for an informal hearing, to confirm or terminate a detention order within five days of an appeal. Section 201(x) of the FFDCA (21 U.S.C. 321(x), defines "informal hearing" and describes the requirements necessary for informal hearings. 21 C.F.R. part 16 outlines FDA's informal hearing procedures in greater detail. Part 16 allows minimum timeframes to request and hold an informal hearing, but provides no requirements or limitations on the length of the informal hearing. FDA is finalizing a rule tailored to the administrative detention provisions in the Bioterrorism Act which necessitates some modifications to the provisions in part 16. If FDA were to include the minor modifications in a guidance document, FDA would not be able to enforce the new provisions because guidance documents are not binding (21 C.F.R. 10.115(d)). If FDA chose simply to follow part 16, the agency would run the risk of not providing the presiding officer sufficient time to consider and weigh the evidence for the informal hearing within the statutory timeframes required by the Bioterrorism Act.

Anticipated Costs and Benefits: In the analysis of the proposed rule, we estimated that this rule would result in social costs of $0 to $38 million per year due to product transportation, storage, loss of product value during storage, marking or labeling, and the cost of appeals. We may need to revise these estimates after reviewing the comments we received on the proposed rule. Administrative detention would generate benefits because it improves our ability to respond to outbreaks from accidental and deliberate contamination of food, and to deter deliberate contamination. We have insufficient information to estimate benefits.

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.