A bill to provide for the enhanced control of biological agents and toxins.

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.