A bill to set up a certification system for research facilities that possess dangerous biological agents and toxins, and for other purposes.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Deadly Biological Agent Control Act 
of 2001''.

SEC. 2. BIOLOGICAL WEAPONS.

    (a) Select Agents.--Section 175 of title 18, United States Code, is 
amended by striking subsection (b) and inserting the following:
    ``(b) Select Agents.--
            ``(1) Uncertified possession.--Whoever knowingly possesses 
        a select agent without obtaining a certification from the 
        Department of Health and Human Services under section 511(f) of 
        the Antiterrorism and Effective Death Penalty Act of 1996, 
        shall be fined under this title, imprisoned for not more than 5 
        years, or both.
            ``(2) Transfer to uncertified person.--Any research 
        facility that knowingly transfers a select agent to an entity 
        that has not obtained a certification from the Department of 
        Health and Human Services under section 511(f) of the 
        Antiterrorism and Effective Death Penalty Act of 1996, shall be 
        fined under this title, imprisoned for not more than 5 years, 
        or both.
    ``(c) Definitions.--In this section:
            ``(1) Biological agent; toxin.--The terms `biological 
        agent' and `toxin' have the same meanings given those terms in 
        section 178, except that, for purposes of subsection (b), if 
        the biological agent or toxin has not been cultivated, 
        cultured, collected, or otherwise extracted from its natural 
        source, those terms do not include any biological agent or 
        toxin that is in its naturally occurring environment.
            ``(2) For use as a weapon.--The term `for use as a weapon' 
        includes the development, production, transfer, acquisition, 
        retention, or possession of any biological agent, toxin, or 
        delivery system, other than for prophylactic, protective, or 
        other peaceful purposes.
            ``(3) Select agent.--The term `select agent' means a 
        biological agent or toxin that--
                    ``(A) is included on the list established under 
                section 511(d)(1) of the Antiterrorism and Effective 
                Death Penalty Act of 1996; and
                    ``(B) is not possessed by a health, research, or 
                other entity listed under subparagraph (C) or (D) of 
                section 511(f)(2) of that Act.''.
    (b) List of Biological Toxins.--Section 511(d) of the Antiterrorism 
and Effective Death Penalty Act of 1996 (42 U.S.C. 262 note) is amended 
to read as follows:
    ``(d) Regulatory Control of Biological Agents.--
            ``(1) List of biological agents and toxins.--The Secretary, 
        in consultation with the Secretary of Defense, Attorney 
        General, and other appropriate Federal officials, shall--
                    ``(A) annually review the existing list of select 
                agents; and
                    ``(B) if necessary, revise that existing list of 
                select agents.
            ``(2) Criteria.--In determining whether to include a 
        biological agent or toxin on the list established under 
        paragraph (1), the Secretary shall--
                    ``(A) consider--
                            ``(i) the effect on human health of 
                        exposure to each biological agent or toxin;
                            ``(ii) the degree of contagiousness of each 
                        biological agent or toxin and the methods by 
                        which each biological agent or toxin is 
                        transferred to humans;
                            ``(iii) the availability and effectiveness 
                        of vaccines and therapies to treat or prevent 
                        any illness resulting from infection by or 
                        exposure to each biological agent or toxin;
                            ``(iv) the potential use of each biological 
                        agent or toxin in a bioterrorist attack on the 
                        civilian population; and
                            ``(v) any other criteria that the Secretary 
                        considers appropriate; and
                    ``(B) consult with scientific experts who represent 
                appropriate professional groups.
            ``(3) Prioritization of countermeasures.--The Secretary 
        shall prioritize countermeasures, including vaccines, 
        therapies, medical devices, and diagnostic tests which must be 
        developed, produced, or obtained in preparation for a 
        bioterrorist attack or other significant disease emergency in 
        order to treat, prevent, or identify infection by, or exposure 
        to, biological agents and toxins, listed pursuant to this 
        subsection.''.
    (c) Regulation of Possession of Biological Agents and Toxins.--
Section 511(f) of the Antiterrorism and Effective Death Penalty Act of 
1996 (42 U.S.C. 262 note) is amended to read as follows:
    ``(f) Possession and Use of Listed Biological Agents and Toxins.--
            ``(1) Standards and procedures.--The Secretary shall 
        provide for the establishment and enforcement of standards and 
        procedures governing the possession and use of biological 
        agents and toxins listed pursuant to subsection (d)(1), in 
        order to protect the health and safety of the public, including 
        safeguards to prevent access to those biological agents and 
        toxins for use in domestic or international terrorism, or for 
        any other criminal purpose.
            ``(2) Certification.--
                    ``(A) In general.--The Secretary shall establish a 
                certification process for the possession and use of 
                biological agents and toxins listed pursuant to 
                subsection (d)(1).
                    ``(B) Possession.--Except as provided in 
                subparagraph (C), the certification process established 
                under subparagraph (A) shall prohibit any individual 
                from knowingly possessing biological agents or toxins 
                listed pursuant to subsection (d)(1).
                    ``(C) Exception.--A health, research, or other 
                entity may possess a biological toxin or agent listed 
                pursuant to subsection (d)(1), if that entity is 
                described in subparagraph (D) or (E).
                    ``(D) Legitimate purpose.--A health, research, or 
                other entity is described in this subparagraph, if--
                            ``(i) the health, research, or other entity 
                        is certified as legitimate by the Department of 
                        Health and Human Services;
                            ``(ii) the research facility has a 
                        legitimate research or other peaceful purpose 
                        for possessing the biological agent or toxin;
                            ``(iii) the research facility submits to 
                        periodic site inspections; and
                            ``(iv) the health, research, or other 
                        entity demonstrates the establishment and 
                        enforcement of safety procedures for the 
                        possession of biological agents or toxins 
                        listed pursuant to subsection (d), including 
                        measures to ensure--
                                    ``(I) proper training and 
                                appropriate skills for handling the 
                                biological agents and toxins;
                                    ``(II) proper laboratory facilities 
                                to contain and dispose of the 
                                biological agents and toxins; and
                                    ``(III) safeguards to prevent 
                                access to the biological agents and 
                                toxins for use in domestic or 
                                international terrorism, or for any 
                                other criminal purpose.
                    ``(E) Diagnostic or verification purpose.--A 
                health, research, or other entity is described in this 
                subparagraph, if the entity--
                            ``(i) possesses the biological agent or 
                        toxin as part of a clinical specimen intended 
                        for diagnostic or verification purposes;
                            ``(ii) transfers the biological agent or 
                        toxin to another entity that is certified under 
                        this subsection, or disposes of the biological 
                        agent or toxin within 72 hours in accordance 
                        with section 72.6(i) of title 42, Code of 
                        Federal Regulations; and
                            ``(iii) reports the presence of the 
                        biological agent or toxin to the Centers for 
                        Disease Control.
            ``(3) Research facilities.--
                    ``(A) In general.--Any individual who handles 
                biological agents or toxins in an entity certified 
                under this subsection shall--
                            ``(i) pass a criminal background check, 
                        which shall include a determination of whether 
                        that individual is a restricted person (as that 
                        term is defined in section 175b of title 18, 
                        United States Code); and
                            ``(ii) be registered with the Department of 
                        Health and Human Services for  the specific 
research project that requires the use of biological agents or toxins.
                    ``(B) Penalties.--
                            ``(i) Research facilities.--Any entity that 
                        is certified under this subsection and permits 
                        a restricted person, as that term is defined in 
                        section 175b of title 18, United States Code, 
                        to handle or access biological agents or toxins 
                        may be subject to decertification by the 
                        Department of Health and Human Services and 
                        civil penalties in an amount not to exceed 
                        $500,000.
                            ``(ii) Supervisory personnel.--Supervisory 
                        personnel in an entity that is certified under 
                        this subsection, who knowingly permit a 
                        restricted person, as that term is defined in 
                        section 175b of title 18, United States Code, 
                        to handle or access biological agents or toxins 
                        shall be subject to civil penalties in an 
                        amount not to exceed $250,000 and shall be 
                        imprisoned for not more than 1 year.''.
    (d) Civil Penalties.--Section 511 of the Antiterrorism and 
Effective Death Penalty Act of 1996 (42 U.S.C. 262 note) is amended 
by--
            (1) redesignating subsection (g) as subsection (h); and
            (2) inserting after subsection (f) the following:
    ``(g) Civil Penalty.--A person who violates subsection (e) or (f) 
shall be subject to the United States for a civil penalty in an amount 
not to exceed $250,000 in the case of an individual and $500,000 in the 
case of an entity certified under subsection (f).''.
    (e) Section 511.--
            (1) In general.--Section 511 of the Antiterrorism and 
        Effective Death Penalty Act of 1996 (42 U.S.C 262 note) is 
        amended--
                    (A) in subsection (e)--
                            (i) by inserting ``and toxins'' after 
                        ``agents'' each place that term appears; and
                            (ii) by inserting ``or toxin'' after 
                        ``agent'' each place that term appears; and
                    (B) in subsection (h)(1), as redesignated by this 
                Act, by striking ``the term `biological agent' has'' 
                and inserting ``the terms `biological agent' and 
                `toxin' have''.
            (2) Effective date.--The amendments made by this subsection 
        shall be deemed to have the same effective date as section 511 
        of the Antiterrorism and Effective Death Penalty Act of 1996 
        (42 U.S.C. 262 note).
    (f) Conforming Amendments.--Section 511(e) of the Antiterrorism and 
Effective Death Penalty Act of 1996 (42 U.S.C. 262 note) is amended--
            (1) in the matter preceding paragraph (1), by striking ``, 
        through regulation promulgated under subsection (f),''; and
            (2) in the heading, by striking ``Agents'' and inserting 
        ``Agents and Toxins''.

SEC. 3. INTERIM RULE.

    (a) In General.--Not later than 30 days after the date of enactment 
of this Act, the Secretary of Health and Human Services shall 
promulgate an interim final rule for carrying out section 511(d) of the 
Antiterrorism and Effective Death Penalty Act of 1996 (42 U.S.C. 262 
note), as amended by this Act.
    (b) Effective Date.--The interim final rule promulgated under 
subsection (a) shall take effect 60 days after the date on which the 
rule is promulgated, including for purposes of--
            (1) section 175(b)(1) of title 18, United States Code 
        (relating to criminal penalties), as added by this Act; and
            (2) section 511(g) of the Antiterrorism and Effective Death 
        Penalty Act of 1996 (relating to civil penalties), as added by 
        this Act.

SEC. 4. REGISTRATION OF BIOLOGICAL AGENTS AND TOXINS.

    In the case of a research facility that, as of the date of 
enactment of this Act, is in possession of a biological agent or toxin 
that is listed pursuant to section 511(d) of the Antiterrorism and 
Effective Death Penalty Act of 1996, as amended by this Act, that 
research facility shall, in accordance with the interim final rule 
promulgated under section 3, submit an application for certification 
under section 511(f) of the Antiterrorism and Effective Death Penalty 
Act of 1996, not later than 30 days after the date on which the rule is 
promulgated.

Summary: Deadly Biological Agent Control Act of 2001 - Revises Federal criminal code provisions regarding biological weapons to set penalties for: (1) knowingly possessing a select biological agent or toxin without obtaining a certification from the Department of Health and Human Services (HHS) under the Antiterrorism and Effective Death Penalty Act of 1996 (AEDPA). And (2) any research facility knowingly transferring a select agent to an entity that has not obtained such certification. Amends the AEDPA to direct the Secretary of HHS to: (1) annually review the existing list of select agents and, if necessary, revise the list. (2) prioritize countermeasures, including vaccines, therapies, medical devices, and diagnostic tests which must be developed, produced, or obtained in preparation for a bioterrorist attack or other significant disease emergency to treat, prevent, or identify infection by, or exposure to, listed biological agents and toxins. And (3) provide for the establishment and enforcement of standards and procedures governing the possession and use of listed agents. Requires the Secretary to establish a certification process for the possession and use of listed agents. Sets forth legitimate purposes. Requires any individual who handles listed agents to pass a criminal background check, including a determination of whether that individual is a restricted person, and to be registered with the Department of HHS for the specific research project that requires the use of biological agents or toxins. Sets penalties for violations.