article: SECTION 1. SHORT TITLE. This Act may be cited as the ``Bioweapons Control and Tracking Act of 2001''. SEC. 2. REGULATION OF BIOLOGICAL AGENTS AND TOXINS. (a) Biological Agents Provisions of the Antiterrorism and Effective Death Penalty Act of 1996; Codification in the Public Health Service Act, With Amendments.-- (1) Public health service act.--Subpart 1 of part F of title III of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended by inserting after section 351 the following: ``SEC. 351A. ENHANCED CONTROL OF BIOLOGICAL AGENTS AND TOXINS. ``(a) Regulatory Control of Biological Agents and Toxins.-- ``(1) List of biological agents and toxins.-- ``(A) In general.--The Secretary shall by regulation establish and maintain a list of each biological agent and each toxin that has the potential to pose a severe threat to public health and safety. ``(B) Criteria.--In determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall-- ``(i) consider-- ``(I) the effect on human health of exposure to the agent or toxin; ``(II) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans; ``(III) the availability and effectiveness of immunizations to prevent and treatments for any illness resulting from infection by the agent or toxin; and ``(IV) any other criteria that the Secretary considers appropriate; and ``(ii) consult with appropriate Federal departments and agencies, and with scientific experts representing appropriate professional groups. ``(2) Biennial review.--The Secretary shall review the list under paragraph (1) biennially, or more often, and republish the list as necessary to incorporate revisions to protect the public health and safety. ``(b) Regulation of Possession, Use, and Transfer of Listed Biological Agents and Toxins.--The Secretary shall by regulation provide for-- ``(1) the establishment and enforcement of safety standards and procedures for the possession, use and transfer of biological agents and toxins listed pursuant to subsection (a)(1), including measures to ensure-- ``(A) proper training and appropriate skills to handle such agents and toxins; and ``(B) proper laboratory facilities to contain and dispose of such agents and toxins; ``(2) the establishment and enforcement of safeguards and security standards and procedures to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose; ``(3) the establishment of procedures to protect the public safety in the event of a violation of the safety procedures established under paragraph (1) or the safeguards established under paragraph (2); and ``(4) appropriate availability of biological agents and toxins for research, education, and other legitimate purposes. ``(c) Registration and Traceability Mechanisms; Database.-- Regulations under subsection (b) shall require registration of the possession, use, and transfer of biological agents and toxins listed pursuant to subsection (a)(1), and such registration shall include information available to the registered persons regarding the characterization of such biological agents and toxins to facilitate their identification and traceability. The Secretary shall maintain a national database of the location of such agents and toxins, with their characterizations. ``(d) Security and Safeguards.-- ``(1) In general.--In carrying out paragraphs (2) and (3) of subsection (b), the Secretary shall establish appropriate security requirements for persons possessing, using, or transferring biological agents and toxins listed pursuant to subsection (a)(1), and shall ensure compliance with such requirements as a condition of registration under regulations issued under subsection (c). In developing such requirements the Secretary shall consult with the Attorney General and appropriate security experts. ``(2) Restricted persons.--Regulations issued under subsection (b) shall include provisions-- ``(A) to restrict access to biological agents and toxins listed pursuant to subsection (a)(1) only to those individuals who need to handle or use such agents or toxins; and ``(B) to provide for prompt screening of such persons using criminal, immigration, and national security databases available to the Federal Government to identify persons who are restricted persons, as defined in section 175b of title 18, United States Code. ``(e) Inspections.--The Secretary shall have the authority to inspect persons subject to regulations under subsection (b) to ensure their compliance with such regulations. ``(f) Exemptions.--The Secretary may establish exemptions from the applicability of provisions of regulations under subsection (b) if the Secretary determines that the exemptions are consistent with protecting the public health and safety. Any exemption from registration under subsection (c) shall be based on transience of possession or on the lack of utility of the agent or toxin for use as a weapon, and shall be consistent with maintaining a complete database under such subsection (c). ``(g) Disclosure of Information.-- ``(1) In general.--Any information in the possession of any Federal agency that identifies a person, or the geographic location of a person, who is registered pursuant to regulations under this section (including regulations promulgated before the effective date of this subsection), and any site-specific information relating to the type, quantity, or identity of a biological agent or toxin listed pursuant to subsection (a)(1) or the site-specific security mechanisms in place to protect such agents and toxins, shall not be disclosed under section 552(a) of title 5, United States Code. ``(2) Disclosures for public health and safety; congress.-- Nothing in this section may be construed as preventing the head of any Federal agency-- ``(A) from making disclosures of information described in paragraph (1) for purposes of protecting the public health and safety; or ``(B) from making disclosures of such information to any committee or subcommittee of Congress with appropriate jurisdiction upon request. ``(h) Civil Penalty.--In addition to any other penalties that may apply under law, any person who violates any provision of regulations under subsection (b) shall be subject to the United States for a civil penalty in an amount not exceeding $250,000 in the case of an individual and $500,000 in the case of any other person. ``(i) Definitions.--For purposes of this section, the terms `biological agent' and `toxin' have the meanings given such terms in section 178 of title 18, United States Code.''. (2) Relation to other laws.-- (A) Rule of construction.--Regulations promulgated by the Secretary of Health and Human Services under section 511 of the Antiterrorism and Effective Death Penalty Act of 1998 are deemed to have been promulgated under section 351A of the Public Health Service Act, as added by paragraph (1) of this subsection. Such regulations, including the list under subsection (d)(1) of such section 511, that were in effect on the day before the date of the enactment of this Act remain in effect until modified by the Secretary. (B) Conforming amendment.--Subsections (d), (e), (f), and (g) of section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 (42 U.S.C. 262 note) are repealed. (3) Regulations regarding registration.-- (A) Date certain for promulgation; effective date regarding criminal and civil penalties.--Not later than 30 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate an interim final rule for carrying out section 351A(c) of the Public Health Service Act, as added by paragraph (1) of this subsection. Such interim final rule takes effect 60 days after the date on which such rule is promulgated for purposes of-- (i) section 175B (b) and (c) of title 18, United States Code (relating to criminal penalties, as added by subsection (b) of this section; and (ii) section 351(h) of the Public Health Service Act (relating to civil penalties). (B) Submission of registration applications.--A person who, as of the date of the interim final rule promulgated under subparagraph (A), is in possession of a biological agent or toxin listed pursuant to section 351A(a) of the Public Health Service Act, as added by paragraph (1) of this subsection, shall in accordance with such interim final rule, submit an application for a registration to possess such agent or toxin not later than 30 days after the date on which such rule is promulgated. (4) Effective date regarding disclosure of information.-- Subsection (g) of section 351A of the Public Health Service Act, as added by paragraph (1) of this subsection, is deemed to have taken effect on the effective date of the Antiterrorism and Effective Death Penalty Act of 1996. (b) Select Agents.-- (1) In general.--Section 175b of title 18, United States Code, as added by section 817 of Public Law 107-56, is amended-- (A) by striking ``(a)'' and inserting ``(a)(1)''; (B) by transferring subsection (c) from the current placement of the subsection and inserting the subsection before subsection (b). (C) by striking ``(c)'' and inserting ``(2)''; (D) by redesignating subsection (b) as subsection (d); and (E) by inserting before subsection (d) as so redesignated) the following subsections: ``(b) Unregistered for Possession or Transfer.--Whoever knowingly possesses or transfers a select agent for which such person has not obtained a registration required by a regulation issued under section 351A(c) of the Public Health Service Act shall be fined under this title, or imprisoned for not more than 5 years, or both. ``(c) Transfer to Unregistered Person.--Whoever knowingly transfers a select agent to a person who has not obtained a registration required by a regulation issued under subsection (c) of section 351A of the Public Health Service Act shall be fined under this tile, or imprisoned for not more than 5 years, or both.''. (c) Report to Congress.--Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, after consultation with other appropriate Federal agencies, shall submit to Congress a report that-- (1) describes the extent to which there has been compliance by governmental and private entities with applicable regulations under section 351A of the Public Health Service Act (as added by subsection (a)(1)); (2) describes the actions taken by the date of the report and future plans of the Secretary for updating the list of biological agents and toxins under such section 351A; (3) describes the actions taken by the date of the report and future plans of the Secretary for determining compliance with regulations under such section 351A and for taking appropriate enforcement actions; and (4) provides any recommendations of the Secretary for administrative or legislative initiatives regarding such section 351A.
summary: Bioweapons Control and Tracking Act of 2001 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services to: (1) establish and maintain a list of each biological agent and each toxin with potential to severely threaten public health and safety; (2) promulgate regulations establishing safety and security standards, procedures, restricted access, and registration requirements for listed agents and toxins, including traceability mechanisms; and (3) establish exemptions consistent with public safety. Imposes civil penalties for violations of these requirements.