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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 Bioterrorism Act contains the term "serious adverse health consequences" to describe the standard relating to exercising many of the new authorities provided therein. Together with the final rules implementing sections 303, 306, and 307 of the Bioterrorism Act, and the other sections of the Bioterrorism Act incorporating the "serious adverse health consequences" term, a definition of the term will further enable FDA to act quickly and consistently in responding to a threatened or actual terrorist attack on the U.S. food supply or to other food-related, public health emergencies. A definition of the "serious adverse health consequences" term will promote uniformity and consistency across FDA in understanding of the term and determining an appropriate response. In addition, a definition of the term will inform the public and stakeholders about what FDA considers to be a serious adverse health consequence under the Bioterrorism Act.

Summary of the Legal Basis: FDA is relying on section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371) in issuing this proposed rule. FDA is also relying on the following sections of the Bioterrorism Act which the term "serious adverse health consequences" appears: Section 303(a) (21 U.S.C. 334(h)(1)(A)), Section 303(c) (21 U.S.C. 381(j)(1)), Section 304(a)(2)(C) (21 U.S.C. 335a(b)(3)), Section 306(a) (21 U.S.C. 350c(a) and (b)), Section 306(b) (21 U.S.C. 374(a)(1)), Section 307(a) (21 U.S.C. 381(m)(2)(B)(ii)), Section 308(b) (21 U.S.C. 343(v)), and Section 310 (21 U.S.C. 398(a)).

Alternatives: In the interests of quickly providing the agency's interpretation of "serious adverse health consequences" to the public, FDA considered explaining the term in guidance. The agency concluded, however, that this option is neither effective nor efficient because guidance does not have the force and effect of law. If the definition or its application is ever challenged, guidance will receive less deference than if the definition were in a regulation. FDA also considered explaining the term in guidance followed by a regulation at a later date. This option was considered because it offers the advantage of rapidly informing the public about the agency's position while the agency gathers more information and experience in applying the definition. The agency concluded that guidance followed by a regulation was undesirable. First, as to the initial guidance, FDA would meet the same problems described above for the "guidance only" option. Second, this option creates a burdensome process for FDA by doubling the agency's responsibilities--first, to publish guidance, and second, to engage in notice and comment rulemaking. FDA resources will be conserved by avoiding this two-step process. Further, there is the possibility that once guidance publishes, a regulation might not follow. As a result, the definition might never have the force and effect of law. FDA also considered defining or explaining "serious adverse health consequences" in preambles to rules promulgated under the Bioterrorism Act. However, implementing regulations are not required for all sections of the Bioterrorism Act that incorporate the term. Thus, the term would not be publicly addressed in the context of all of the applicable sections of the Bioterrorism Act. Second, because preambles are not codified and incorporated into the Code of Federal Regulations, the context and interpretation of the term eventually may become disassociated from the codified regulations. Finally, the rule ing of the Bioterrorism Act had already been published or were going to be published soon when this option was considered. Thus, there was insufficient time to include this discussion in the preambles to the current proposed rules for these sections. FDA also considered adopting one of the two similar definitions for "serious adverse health consequences" or the definition for "serious injury" in the medical devices regulations to promote consistency within the agency and avoid confusion. (In the medical devices reporting regulations, the preamble to the final rule states that "the agency intends for 'serious adverse health consequences' to have the same meaning as 'serious injury' under the [Medical Device Reporting] rule.") This option could promote greater consistency within the agency, avoid confusion, and also save time. However, the agency believes that a broader definition must be used for foods and feeds in order to satisfy Congressional intent. Specifically, it must be clear that the definition of "serious adverse health consequences," for purposes of the Bioterrorism Act, (1) expressly includes vulnerable populations, and (2) expressly apply to food for humans and animals. In addition, there are terms incorporating the concept of "serious" in CDER and CDRH regulations. The definitions of these terms are not entirely consistent because they are tailored to the needs of each Center and apply only to specific portions of the applicable regulations, i.e., they have specific uses and contexts. Thus, a specific definition for "serious adverse health consequences" under the Bioterrorism Act is necessary in order to avoid confusion among differing definitions of "serious," "serious injury," or "serious adverse health consequences" in other regulations, and the context in which these terms are defined and applied. The proposed definition would apply to: (1) all foods and feeds in bioterrorist events and other public health emergencies; and (2) all populations, vulnerable or healthy, effectively having very wide applicability in a wide variety of emergency situations. Finally, FDA considered leaving the term undefined, thereby providing maximum flexibility for determining what constitutes "serious adverse health consequences" on a case-by-case basis. By not defining, the agency could avoid the potential consequences of a definition that is either too broad or too narrow. However, leaving the term undefined could cause confusion and inconsistency in implementation. Moreover, if an agency action under the Act is challenged, an undefined term will be left to a court's interpretation. A court, however, is not the most appropriate or expert body to decide the meaning of "serious adverse health consequences."

Anticipated Costs and Benefits: The impact of this proposed rule will depend on how FDA decides to define the term "serious adverse health consequences," which is used as a standard for taking action under the administrative detention, record keeping, and prior notice provisions of the Bioterrorism Act. The broader the definition, the greater the cost and benefits associated with it. For example, if "serious adverse health consequences" were defined to include any case of foodborne illness, then foods would be administratively detained more often than if the definition were limited to cases resulting in death. A broader definition will mean the term is used more frequently in conjunction with the provisions of the Bioterrorism Act; and therefore, there will be more costs, but there will also be more benefits.

Risks: Regulations implementing legislation to protect the health of citizens against bioterrorism and other public health emergencies 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. This proposed rule would support those regulations by defining a key term contained therein, thereby improving FDA's ability to act quickly and consistently in responding to a threatened or actual terrorist attack on the U.S. food supply or to other food-related, public health emergencies.