text: 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.
target: 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.
feat_title: A bill to provide for the enhanced control of biological agents and toxins.