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HHS/CDC

RIN: 0920-AA08

Publication ID: Spring 2003

Title: Possession, Use, and Transfer of Select Agents
Abstract: On June 12, 2002, President George W. Bush signed Public Law 107-188, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). Title II, subtitle B of the Bioterrorism Act repeals, expands, and incorporates the Secretary's current authority to regulate the transfer of certain biological agents and toxins (select agents) as provided in section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 (Pub. L. 104-132) (42 U.S.C. 262 note) and that Act's implementing regulations (42 CFR 72.6). The Bioterrorism Act specifies that the Secretary develop and biannually review the list of select agents. Safety procedures must be established and enforced for the possession, use, and transfer of listed agents and toxins, and access to select agents is limited to those individuals and entities that pass background checks administered by the Attorney General. The Bioterrorism Act exempts certain information from disclosure under the Freedom of Information Act, including information that would identify the location of regulated entities or their security measures. Subtitle C of the Bioterrorism Act outlines the required interagency coordination between the Department of Health and Human Services and the Department of Agriculture regarding agents that are regulated by both departments (overlap agents). In addition to the interim final rule noted in the timetable below, the Department has also published a notice of proposed data collection (67 FR 44464), a notice of OMB approval of data collection (67 FR 51057), and a notice of preliminary guidance for notification of possession of select agents (67 FR 54605).
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: No	Unfunded Mandates: No
CFR Citation: 42 CFR 72 42 CFR 72.6
Legal Authority: PL 107-188

Legal Deadline:

Action	Source	Description	Date
Final	Statutory		12/09/2002

Statement of Need: Statutorily required by subtitles A and C of title II of the Bioterrorism Act, Public Law 107-188.

Summary of the Legal Basis: Subtitles A and C of title II of the Bioterrorism Act, Public Law 107-188.

Alternatives: On June 12, 2002, the President signed the Bioterrorism Act into law. Section 202 (a) of the Bioterrorism Act requires that all persons possessing, using, or transferring agents or toxins deemed a threat to public health to notify the Secretary of the Department of Health and Human Services (HHS). Since this is a mandate from Congress, the only alternative for this regulation would be to have HHS go back to Congress to request reconsideration.

Anticipated Costs and Benefits: Modest internal cost implications for HHS/CDC can be foreseen at this time, but the potential costs to entities and individuals required to register under provisions of this rulemaking are currently unknown. CDC has issued a task order for support for the agency's responsibilities for the rulemaking and related requirements of the Bioterrorism Act. The contractor implementing this task order will conduct an analysis of all anticipated costs of the rulemaking. The economic impact information resulting from this analysis will be set out in the preamble of the interim final rule.

Risks: By establishing and enforcing standards for the possession, use, and transfer of potentially lethal biological agents and toxins, the regulation will serve as a preventive mechanism against bioterrorism, which complements some of the Department's other bioterrorism related activities.

Timetable:

Action	Date	FR Cite
Interim Final Rule	12/13/2002	67 FR 76886

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: Yes
Agency Contact: Stephen M. Ostroff MD Department of Health and Human Services Centers for Disease Control and Prevention National Center for Infectious Diseases, 1600 Clifton Road NE., Atlanta, GA 30333 Phone:404 639-3967