[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3306 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 3306
To set up a certification system for research facilities that possess
dangerous biological agents and toxins, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 15, 2001
Mr. Schiff introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
the Judiciary, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To set up a certification system for research facilities that possess
dangerous biological agents and toxins, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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.
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