H. R. 3448—45
‘‘(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
pharmacotherapies and immunizations to treat
and prevent any illness resulting from infection
by the agent or toxin; and
‘‘(IV) any other criteria, including the needs
of children and other vulnerable populations, that
the Secretary considers appropriate; and
‘‘(ii) consult with appropriate Federal departments
and agencies and with scientific experts representing
appropriate professional groups, including groups with
pediatric expertise.
‘‘(2) BIENNIAL
REVIEW.—The Secretary shall review and
republish the list under paragraph (1) biennially, or more often
as needed, and shall by regulation revise the list as necessary
in accordance with such paragraph.
‘‘(b) REGULATION
OF
TRANSFERS
OF
LISTED
AGENTS
AND
TOXINS.—The Secretary shall by regulation provide for—
‘‘(1) the establishment and enforcement of safety procedures
for the transfer of listed agents and toxins, 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 safeguard and
security measures 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 such
an agent or toxin in violation of the safety procedures estab-
lished under paragraph (1) or the safeguard and security meas-
ures 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 AGENTS AND TOXINS.—
The Secretary shall by regulation provide for the establishment
and enforcement of standards and procedures governing the posses-
sion and use of listed agents and toxins, including the provisions
described in paragraphs (1) through (4) of subsection (b), in order
to protect the public health and safety.
‘‘(d) REGISTRATION; IDENTIFICATION; DATABASE.—
‘‘(1) REGISTRATION.—Regulations under subsections (b) and
(c) shall require registration with the Secretary of the posses-
sion, use, and transfer of listed agents and toxins, and shall
include provisions to ensure that persons seeking to register
under such regulations have a lawful purpose to possess, use,
or transfer such agents and toxins, including provisions in
accordance with subsection (e)(6).
‘‘(2) IDENTIFICATION; DATABASE.—Regulations under sub-
sections (b) and (c) shall require that registration include (if
available to the person registering) information regarding the
characterization of listed agents and toxins to facilitate their
H. R. 3448—46
identification, including their source. The Secretary shall main-
tain a national database that includes the names and locations
of registered persons, the listed agents and toxins such persons
are possessing, using, or transferring, and information
regarding the characterization of such agents and toxins.
‘‘(e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REGISTERED
PERSONS.—
‘‘(1) IN GENERAL.—Regulations under subsections (b) and
(c) shall include appropriate safeguard and security require-
ments for persons possessing, using, or transferring a listed
agent or toxin commensurate with the risk such agent or toxin
poses to public health and safety (including the risk of use
in domestic or international terrorism). The Secretary shall
establish such requirements in consultation with the Attorney
General, and shall ensure compliance with such requirements
as part of the registration system under such regulations.
‘‘(2) LIMITING
ACCESS
TO
LISTED
AGENTS
AND
TOXINS.—
Requirements under paragraph (1) shall include provisions to
ensure that registered persons—
‘‘(A) provide access to listed agents and toxins to only
those individuals whom the registered person involved
determines have a legitimate need to handle or use such
agents and toxins;
‘‘(B) submit the names and other identifying informa-
tion for such individuals to the Secretary and the Attorney
General, promptly after first determining that the individ-
uals need access under subparagraph (A), and periodically
thereafter while the individuals have such access, not less
frequently than once every five years;
‘‘(C) deny access to such agents and toxins by individ-
uals whom the Attorney General has identified as restricted
persons; and
‘‘(D) limit or deny access to such agents and toxins
by individuals whom the Attorney General has identified
as within any category under paragraph (3)(B)(ii), if lim-
iting or denying such access by the individuals involved
is determined appropriate by the Secretary, in consultation
with the Attorney General.
‘‘(3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY
GENERAL.—
‘‘(A) IN GENERAL.—Upon the receipt of names and other
identifying information under paragraph (2)(B), the
Attorney General shall, for the sole purpose of identifying
whether the individuals involved are within any of the
categories specified in subparagraph (B), promptly use
criminal, immigration, national security, and other elec-
tronic databases that are available to the Federal Govern-
ment and are appropriate for such purpose.
‘‘(B) CERTAIN INDIVIDUALS.—For purposes of subpara-
graph (A), the categories specified in this subparagraph
regarding an individual are that—
‘‘(i) the individual is a restricted person; or
‘‘(ii) the individual is reasonably suspected by any
Federal law enforcement or intelligence agency of—
‘‘(I) committing a crime set forth in section
2332b(g)(5) of title 18, United States Code;
H. R. 3448—47
‘‘(II) knowing involvement with an organiza-
tion that engages in domestic or international ter-
rorism (as defined in section 2331 of such title
18) or with any other organization that engages
in intentional crimes of violence; or
‘‘(III) being an agent of a foreign power (as
defined in section 1801 of title 50, United States
Code).
‘‘(C) NOTIFICATION BY ATTORNEY GENERAL REGARDING
SUBMITTED NAMES.—After the receipt of a name and other
identifying information under paragraph (2)(B), the
Attorney General shall promptly notify the Secretary
whether the individual is within any of the categories
specified in subparagraph (B).
‘‘(4) NOTIFICATIONS BY SECRETARY.—The Secretary, after
receiving notice under paragraph (3) regarding an individual,
shall promptly notify the registered person involved of whether
the individual is granted or denied access under paragraph
(2). If the individual is denied such access, the Secretary shall
promptly notify the individual of the denial.
‘‘(5) EXPEDITED REVIEW.—Regulations under subsections (b)
and (c) shall provide for a procedure through which, upon
request to the Secretary by a registered person who submits
names and other identifying information under paragraph
(2)(B) and who demonstrates good cause, the Secretary may,
as determined appropriate by the Secretary—
‘‘(A) request the Attorney General to expedite the
process of identification under paragraph (3)(A) and
notification of the Secretary under paragraph (3)(C); and
‘‘(B) expedite the notification of the registered person
by the Secretary under paragraph (4).
‘‘(6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.—
‘‘(A) INDIVIDUALS.—Regulations under subsections (b)
and (c) shall provide that an individual who seeks to reg-
ister under either of such subsections is subject to the
same processes described in paragraphs (2) through (4)
as apply to names and other identifying information sub-
mitted to the Attorney General under paragraph (2)(B).
Paragraph (5) does not apply for purposes of this subpara-
graph.
‘‘(B) OTHER PERSONS.—Regulations under subsections
(b) and (c) shall provide that, in determining whether to
deny or revoke registration by a person other than an
individual, the Secretary shall submit the name of such
person to the Attorney General, who shall use criminal,
immigration, national security, and other electronic data-
bases available to the Federal Government, as appropriate
for the purpose of promptly notifying the Secretary whether
the person, or, where relevant, the individual who owns
or controls such person, is a restricted person or is reason-
ably suspected by any Federal law enforcement or intel-
ligence agency of being within any category specified in
paragraph (3)(B)(ii) (as applied to persons, including
individuals). Such regulations shall provide that a person
who seeks to register under either of such subsections
is subject to the same processes described in paragraphs
H. R. 3448—48
(2) and (4) as apply to names and other identifying informa-
tion submitted to the Attorney General under paragraph
(2)(B). Paragraph (5) does not apply for purposes of this
subparagraph. The Secretary may exempt Federal, State,
or local governmental agencies from the requirements of
this subparagraph.
‘‘(7) REVIEW.—
‘‘(A) ADMINISTRATIVE REVIEW.—
‘‘(i) IN GENERAL.—Regulations under subsections
(b) and (c) shall provide for an opportunity for a review
by the Secretary—
‘‘(I) when requested by the individual involved,
of a determination under paragraph (2) to deny
the individual access to listed agents and toxins;
and
‘‘(II) when requested by the person involved,
of a determination under paragraph (6) to deny
or revoke registration for such person.
‘‘(ii) EX PARTE REVIEW.—During a review under
clause (i), the Secretary may consider information rel-
evant to the review ex parte to the extent that disclo-
sure of the information could compromise national
security or an investigation by any law enforcement
agency.
‘‘(iii) FINAL AGENCY ACTION.—The decision of the
Secretary in a review under clause (i) constitutes final
agency action for purposes of section 702 of title 5,
United States Code.
‘‘(B) CERTAIN PROCEDURES.—
‘‘(i) SUBMISSION
OF
EX
PARTE
MATERIALS
IN
JUDICIAL PROCEEDINGS.—When reviewing a decision of
the Secretary under subparagraph (A), and upon
request made ex parte and in writing by the United
States, a court, upon a sufficient showing, may review
and consider ex parte documents containing informa-
tion the disclosure of which could compromise national
security or an investigation by any law enforcement
agency. If the court determines that portions of the
documents considered ex parte should be disclosed to
the person involved to allow a response, the court
shall authorize the United States to delete from such
documents specified items of information the disclosure
of which could compromise national security or an
investigation by any law enforcement agency, or to
substitute a summary of the information to which the
person may respond. Any order by the court author-
izing the disclosure of information that the United
States believes could compromise national security or
an investigation by any law enforcement agency shall
be subject to the processes set forth in subparagraphs
(A) and (B)(i) of section 2339B(f)(5) of title 18, United
States Code (relating to interlocutory appeal and expe-
dited consideration).
‘‘(ii) DISCLOSURE
OF
INFORMATION.—In a review
under subparagraph (A), and in any judical proceeding
conducted pursuant to such review, neither the Sec-
retary nor the Attorney General may be required to