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H.R.3448
Public Health Security and Bioterrorism Response Act of 2001
(Engrossed as Agreed to or Passed by House)
SEC. 201. REGULATION OF CERTAIN 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 DANGEROUS BIOLOGICAL AGENTS AND TOXINS.
`(a) REGULATORY CONTROL OF CERTAIN 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) 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 scientific experts representing appropriate
professional groups.
`(2) BIENNIAL PUBLICATION- The Secretary shall publish the list under
paragraph (1) biennially, or at such more frequent intervals as the
Secretary determines to be appropriate. Before publishing the list, the
Secretary shall review the list, and shall make such revisions as are
appropriate to protect the public health and safety. In reviewing and
revising the list, the Secretary shall consider the needs of vulnerable
populations, including children, and shall consult with appropriate Federal
agencies and State and local public health officials.
`(b) REGULATION OF TRANSFERS OF LISTED BIOLOGICAL AGENTS AND TOXINS- The
Secretary shall by regulation provide for--
`(1) the establishment and enforcement of safety procedures for the
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) safeguards 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 transfer or potential transfer of a biological agent or toxin in
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) POSSESSION AND USE OF LISTED BIOLOGICAL AGENTS AND TOXINS- The
Secretary shall by regulation provide for the establishment and enforcement of
standards and procedures governing the possession and use of biological agents
and toxins listed pursuant to subsection (a)(1) in order to protect the public
health and safety, including the measures, safeguards, procedures, and
availability of such agents and toxins described in paragraphs (1) through (4)
of subsection (b), respectively.
`(d) REGISTRATION AND TRACEABILITY MECHANISMS; DATABASE- Regulations under
subsections (b) and (c) 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 (if available to the registered person)
information 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 information regarding their characterizations.
`(e) INSPECTIONS- The Secretary may conduct inspections to ensure that
persons subject to regulations under subsection (b) or (c) are in compliance
with such regulations, including provisions regarding security and restrictions on access
under subsection (g).
`(f) EXEMPTIONS- The Secretary may establish exemptions from the
applicability of provisions of regulations under subsection (b) or (c) if the
Secretary determines that such exemptions are consistent with protecting the
public health and safety. In the case of a clinical laboratory that is in possession of a
biological agent or toxin listed pursuant to subsection (a)(1), such an
exemption may be provided only if such agent or toxin has been presented for
diagnosis, verification, or proficiency testing, and upon identification or
verification of the agent or toxin, such laboratory --
`(1) promptly notifies the Secretary or other public health authorities
when required under Federal or State law; and
`(2) transfers or destroys the agent or toxin in accordance with such
regulations.
`(g) SECURITY REQUIREMENTS
FOR REGISTERED PERSONS-
`(1) IN GENERAL- In carrying out the provisions of subsections (b) and
(c) that relate to safeguards, the Secretary, in consultation with the
Attorney General, shall by regulation establish appropriate security requirements for persons
possessing, using, or transferring biological agents or toxins listed
pursuant to subsection (a)(1), and ensure compliance with such requirements
as a condition of registration under subsection (b) or (c).
`(2) LIMITING ACCESS TO LISTED AGENTS AND TOXINS-
`(A) IN GENERAL- Regulations issued under subsections (b) and (c)
shall include provisions--
`(i) to restrict access to biological agents and toxins listed
pursuant to subsection (a)(1) to only those individuals who have a
legitimate need for access, as determined according to the purposes for
which the registration under such regulations is provided;
and
`(ii) to ensure that individuals granted such access are
not--
`(I) restricted persons, as defined in section 175b of title 18,
United States Code;
`(II) named in a warrant issued to a Federal or State law
enforcement agency for participation in any domestic or international
act of terrorism or
other act of violence;
`(III) under investigation for involvement with a domestic or
international terrorist or criminal organization by any Federal law
enforcement or intelligence agency; or
`(IV) suspected by any Federal law enforcement or intelligence
agency of seeking to obtain covertly information relating to
biological agents or toxins on behalf of the intelligence or military
operations of a foreign nation.
`(B) SCREENING PROTOCOL- To carry out subparagraph (A), the Secretary
shall require that registered persons promptly submit the names and other
identifying information for individuals described in subparagraph (A)(i)
to the Secretary and the Attorney General, with which information the
Attorney General shall promptly use criminal, immigration, and national
security databases available
to the Federal Government to identify whether such individuals satisfy the
conditions for access under subparagraph (A)(ii). The Secretary, in
consultation with the Attorney General and other Federal agencies, shall
periodically review and as appropriate revise the protocol for screening
individuals for purposes of subparagraph (A), and may require by
regulation additional screening measures if determined necessary to
achieve the purposes of this section.
`(3) ASSISTANCE FOR CERTAIN ENTITIES- The Secretary, in consultation
with the Attorney General, may make awards of grants, contracts, or
cooperative agreements to public and nonprofit private entities (other than
Federal agencies), and may provide technical assistance to such entities, to
improve security of the
facilities of registered persons.
`(h) 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 the Congress with appropriate jurisdiction, upon
request.
`(i) CIVIL MONEY PENALTY-
`(1) IN GENERAL- In addition to any other penalties that may apply under
law, any person who violates any provision of regulations under subsection
(b) or (c) shall be subject to the United States for a civil money penalty
in an amount not exceeding $250,000 in the case of an individual and
$500,000 in the case of any other person.
`(2) APPLICABILITY OF CERTAIN PROVISIONS- The provisions of section
1128A of the Social Security
Act (other than subsections (a), (b), (h), and (i), the first sentence of
subsection (c), and paragraphs (1) and (2) of subsection (f)) shall apply to
a civil money penalty under paragraph (1) in the same manner as such
provisions apply to a penalty or proceeding under section 1128A(a) of such
Act. The Secretary may delegate authority under this subsection in the same
manner as provided in section 1128A(j)(2) of the Social Security Act, and such authority
shall include all powers as contained in section 6 of the Inspector General
Act of 1978.
`(j) COORDINATION WITH REGULATIONS UNDER VIRUS-SERUM-TOXIN ACT-
`(1) IN GENERAL- In establishing and enforcing regulations under
subsections (b) and (c), the Secretary shall consult with the Secretary of
Agriculture to ensure that such activities are coordinated, to the greatest
extent practicable, with regulations governing certain biological agents and
toxins listed pursuant to subsection (a)(1) issued by the Secretary of
Agriculture under the Act commonly known as the Virus-Serum-Toxin Act (the
eighth paragraph under the heading `Bureau of Animal Industry' in the Act of
March 4, 1913; 21 U.S.C. 151-159) (in this subsection referred to as the
`VST Act'). The purpose of such coordination shall be--
`(A) to minimize any conflicts between the regulations issued by, or
the activities of, the Secretary of Health and Human Services and the
Secretary of Agriculture with respect to such agents and toxins;
`(B) to minimize the administrative burden on persons subject to
regulations under both this section and the VST Act;
`(C) to ensure the appropriate availability of such agents and toxins
for legitimate agricultural or veterinary research, education, or other
such purposes; and
`(D) to ensure the establishment of a national database of such agents
or toxins pursuant to subsection (d).
`(2) PERSONS REGULATED BY DEPARTMENT OF AGRICULTURE- With respect to
persons possessing or using biological agents or toxins listed pursuant to
subsection (a)(1) who, as of the date of enactment of the Public Health
Security and Bioterrorism
Response Act of 2001, possess an unexpired, unrevoked, and unsuspended
permit or license from the Department of Agriculture for such possession or
use, such persons may, for purposes of registration under subsection (b) or
(c), submit to the Secretary of Health and Human Services the same
information previously provided to the Secretary of Agriculture to obtain
such permit or license, provided that the information so submitted is
accurate as of the time of submittal to the Secretary of Health and Human
Services, and provided further that such Secretary may, after review of such
submission, request such additional information as the Secretary determines
to be necessary to achieve the purposes of this section.
`(3) SAVINGS PROVISION- Nothing in this section shall be construed as
limiting any authority of the Secretary of Agriculture under the VST Act or
any regulations issued thereunder.
`(k) DEFINITIONS- For purposes of this section:
`(1) The terms `biological agent' and `toxin' have the meanings given
such terms in section 178 of title 18, United States Code.
`(2) The term `registered person' means a person registered under
regulations under subsection (b) or (c).
`(l) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this
section, there are authorized to be appropriated such sums as may be necessary
for each of the fiscal years 2002 through 2006.'.
(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 1996 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 (including any revisions required under
subsection (a)(2) of such section 351A).
(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) DATE CERTAIN FOR PROMULGATION OF CERTAIN REGULATIONS; EFFECTIVE DATE
REGARDING CRIMINAL AND CIVIL PENALTIES- With respect to section 351A of the
Public Health Service Act (as added by paragraph (1) of this
subsection):
(A) 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 requiring all persons in possession of biological
agents or toxins listed pursuant to subsection (a)(1) of such section
(unless exempt under subsection (e) of such section) to provide notice to
the Secretary of such possession, and to include in the notice such
additional information as the Secretary may require for compliance with
subsection (d) of such section or any other provision of such section, by
not later than 30 days after the date on which such rule is promulgated.
Such interim final rule takes effect on the date on which the rule is
promulgated, except as follows:
(i) For purposes of section 175b(c) of title 18, United States Code
(relating to criminal penalties), as added by subsection (a)(1)(E) of
this section, the rule takes effect 60 days after the date on which the
rule is promulgated.
(ii) For purposes of subsection (i) of such section 351A (relating
to civil penalties), the rule takes effect 60 days after the date on
which the rule is promulgated.
(B) Not later than 120 days after the date of enactment of this Act,
such Secretary shall promulgate an interim final rule for carrying out
subsections (b) and (c) of such section 351A. Such interim final rule
takes effect 60 days after the date on which the rule is
promulgated.
(4) EFFECTIVE DATE REGARDING DISCLOSURE OF INFORMATION- Subsection (h)
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) CRIMINAL PENALTIES REGARDING 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) TRANSFER TO UNREGISTERED PERSON- Whoever knowingly transfers a select
agent to a person without first verifying with the Secretary of Health and
Human Services that the person has obtained a registration required by
regulations under subsection (b) or (c) of section 351A of the Public Health
Service Act shall be fined under this title, or imprisoned for not more than 5
years, or both.
`(c) UNREGISTERED FOR POSSESSION- Whoever knowingly possesses a biological
agent or toxin where such agent or toxin is a select agent for which such
person has not obtained a registration required by regulations 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.'.
(2) CONFORMING AMENDMENTS- Chapter 10 of title 18, United States Code,
is amended--
(A) in section 175b (as added by section 817 of Public Law 107-56 and
amended by paragraph (1) of this subsection)--
(i) in subsection (d)(1), by striking `The term' and all that
follows through `does not include' and inserting the following: `The
term `select agent' means a biological agent or toxin to which
subsection (a) applies. Such term (including for purposes of subsection
(a)) does not include'; and
(ii) in the heading for the section, by striking `Possession by
restricted persons' and inserting `Select agents';
and
(B) in the chapter analysis, in the item relating to section 175b, by
striking `Possession by restricted persons.' and inserting `Select
agents.'.
(3) TECHNICAL CORRECTIONS- Chapter 10 of title 18, United States Code,
as amended by section 817 of Public Law 107-56 and paragraphs (1) and (2) of
this subsection, is amended--
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