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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, 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), 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 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. Furthermore, section 303 of the Bioterrorism Act amends section 801 of the FFDCA to provide for temporary holds at ports of entry.

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 an informal hearing, to confirm or terminate a detention order within five days of an appeal. Section 201(x) of the FFDCA defines "informal hearing" and describes the requirements necessary for informal hearings. 21 CFR part 16 of FDA's regulations outlines FDA's informal hearing procedures in greater detail. Part 16 provides no requirements or limitations on the length of the informal hearing. FDA proposes to adopt part 16 with minor modifications (e.g., limiting length of hearing, delegating Secretary's duties as presiding officer to an FDA official in a regulation tailored to the administrative detention provisions in the Bioterrorism Act. If FDA were to include the minor modifications in a guidance document, FDA would not be able to enforce legally the new provisions because guidance documents are not binding (21 CFR 10.115(d)). If FDA chose simply to follow part 16, we 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.

Anticipated Costs and Benefits: Administrative detention actions on imports would generate two types of costs: 1) enforcement costs, including marking or labeling, transporting, and storing detained or held products in secure facilities, as necessary, and the cost of preparing and administering detention appeal hearings; and 2) the loss of product value during the detention period (in the case of products that we detain or hold but that turn out to be non-violative) and firms' costs for preparing for detention appeal hearings. In those cases in which we could have used other means to detain the relevant goods (i.e., collaboration with states or Customs, or our own existing authority to detain imports, shell eggs, and infant formula), only the net change in these costs would be relevant to this rule. We do not have sufficient information to estimate these costs at this time. However, annual costs would probably be fairly small because we would only use these procedures under rare, extraordinary circumstances. In addition to potentially reducing enforcement costs, product value loss, and firms' appeals hearing preparation costs relative to current methods of detention, this rule would generate benefits by improving our ability to detect accidental and deliberate contamination of food and to deter deliberate contamination.

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.