42 U.S.C. § 262a : US Code - Section 262A: Enhanced control of dangerous biological agents and toxins

Search 42 U.S.C. § 262a : US Code - Section 262A: 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) 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
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
established under paragraph (1) or the safeguard and security
measures 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
possession and use of listed agents and toxins, including the
provisions described in paragraphs (1) through (4) of subsection
(b) of this section, in order to protect the public health and
safety.
(d) Registration; identification; database
(1) Registration
Regulations under subsections (b) and (c) of this section shall
require registration with the Secretary of the possession, 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) of this section.
(2) Identification; database
Regulations under subsections (b) and (c) of this section shall
require that registration include (if available to the person
registering) information regarding the characterization of listed
agents and toxins to facilitate their identification, including
their source. The Secretary shall maintain 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) of this section shall
include appropriate safeguard and security requirements 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 collaboration with the Secretary of Homeland
Security and 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 information for
such individuals to the Secretary and the Attorney General,
promptly after first determining that the individuals 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 individuals 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 limiting 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 electronic databases that are available to the Federal
Government and are appropriate for such purpose.
(B) Certain individuals
For purposes of subparagraph (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;
(II) knowing involvement with an organization that
engages in domestic or international terrorism (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).
(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) of this section 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) of this section
shall provide that an individual who seeks to register 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 submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not apply for
purposes of this subparagraph.
(B) Other persons
Regulations under subsections (b) and (c) of this section
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 databases 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 reasonably suspected by any Federal law
enforcement or intelligence 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 (2)
and (4) as apply to names and other identifying information
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) of this section
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 relevant to the review ex parte to the
extent that disclosure 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.
(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 information 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 authorizing 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 (relating to
interlocutory appeal and expedited consideration).
(ii) Disclosure of information
In a review under subparagraph (A), and in any judical (!1)
proceeding conducted pursuant to such review, neither the
Secretary nor the Attorney General may be required to
disclose to the public any information that under subsection
(h) of this section shall not be disclosed under section 552
of title 5.
(8) Notifications regarding theft or loss of agents
Requirements under paragraph (1) shall include the prompt
notification of the Secretary, and appropriate Federal, State,
and local law enforcement agencies, of the theft or loss of
listed agents and toxins.
(9) Technical assistance for registered persons
The Secretary, in consultation with the Attorney General, may
provide technical assistance to registered persons to improve
security of the facilities of such persons.
(f) Inspections
The Secretary shall have the authority to inspect persons subject
to regulations under subsection (b) or (c) of this section to
ensure their compliance with such regulations, including
prohibitions on restricted persons and other provisions of
subsection (e) of this section.
(g) Exemptions
(1) Clinical or diagnostic laboratories
Regulations under subsections (b) and (c) of this section shall
exempt clinical or diagnostic laboratories and other persons who
possess, use, or transfer listed agents or toxins that are
contained in specimens presented for diagnosis, verification, or
proficiency testing, provided that -
(A) the identification of such agents or toxins is reported
to the Secretary, and when required under Federal, State, or
local law, to other appropriate authorities; and
(B) such agents or toxins are transferred or destroyed in a
manner set forth by the Secretary by regulation.
(2) Products
(A) In general
Regulations under subsections (b) and (c) of this section
shall exempt products that are, bear, or contain listed agents
or toxins and are cleared, approved, licensed, or registered
under any of the Acts specified in subparagraph (B), unless the
Secretary by order determines that applying additional
regulation under subsection (b) or (c) of this section to a
specific product is necessary to protect public health and
safety.
(B) Relevant laws
For purposes of subparagraph (A), the Acts specified in this
subparagraph are the following:
(i) The Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301
et seq.].
(ii) Section 262 of this title.
(iii) 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).
(iv) The Federal Insecticide, Fungicide, and Rodenticide
Act [7 U.S.C. 136 et seq.].
(C) Investigational use
(i) In general
The Secretary may exempt an investigational product that
is, bears, or contains a listed agent or toxin from the
applicability of provisions of regulations under subsection
(b) or (c) of this section when such product is being used in
an investigation authorized under any Federal Act and the
Secretary determines that applying additional regulation
under subsection (b) or (c) of this section to such product
is not necessary to protect public health and safety.
(ii) Certain processes
Regulations under subsections (b) and (c) of this section
shall set forth the procedures for applying for an exemption
under clause (i). In the case of investigational products
authorized under any of the Acts specified in subparagraph
(B), the Secretary shall make a determination regarding a
request for an exemption not later than 14 days after the
first date on which both of the following conditions have
been met by the person requesting the exemption:
(I) The person has submitted to the Secretary an
application for the exemption meeting the requirements
established by the Secretary.
(II) The person has notified the Secretary that the
investigation has been authorized under such an Act.
(3) Public health emergencies
The Secretary may temporarily exempt a person from the
applicability of the requirements of this section, in whole or in
part, if the Secretary determines that such exemption is
necessary to provide for the timely participation of the person
in a response to a domestic or foreign public health emergency
(whether determined under section 247d(a) of this title or
otherwise) that involves a listed agent or toxin. With respect to
the emergency involved, such exemption for a person may not
exceed 30 days, except that the Secretary, after review of
whether such exemption remains necessary, may provide one
extension of an additional 30 days.
(4) Agricultural emergencies
Upon request of the Secretary of Agriculture, after the
granting by such Secretary of an exemption under section
8401(g)(1)(D) of title 7 pursuant to a finding that there is an
agricultural emergency, the Secretary of Health and Human
Services may temporarily exempt a person from the applicability
of the requirements of this section, in whole or in part, to
provide for the timely participation of the person in a response
to the agricultural emergency. With respect to the emergency
involved, the exemption under this paragraph for a person may not
exceed 30 days, except that upon request of the Secretary of
Agriculture, the Secretary of Health and Human Services may,
after review of whether such exemption remains necessary, provide
one extension of an additional 30 days.
(h) Disclosure of information
(1) Nondisclosure of certain information
No Federal agency specified in paragraph (2) shall disclose
under section 552 of title 5 any of the following:
(A) Any registration or transfer documentation submitted
under subsections (b) and (c) of this section for the
possession, use, or transfer of a listed agent or toxin; or
information derived therefrom to the extent that it identifies
the listed agent or toxin possessed, used, or transferred by a
specific registered person or discloses the identity or
location of a specific registered person.
(B) The national database developed pursuant to subsection
(d) of this section, or any other compilation of the
registration or transfer information submitted under
subsections (b) and (c) of this section to the extent that such
compilation discloses site-specific registration or transfer
information.
(C) Any portion of a record that discloses the site-specific
or transfer-specific safeguard and security measures used by a
registered person to prevent unauthorized access to listed
agents and toxins.
(D) Any notification of a release of a listed agent or toxin
submitted under subsections (b) and (c) of this section, or any
notification of theft or loss submitted under such subsections.
(E) Any portion of an evaluation or report of an inspection
of a specific registered person conducted under subsection (f)
of this section that identifies the listed agent or toxin
possessed by a specific registered person or that discloses the
identity or location of a specific registered person if the
agency determines that public disclosure of the information
would endanger public health or safety.
(2) Covered agencies
For purposes of paragraph (1) only, the Federal agencies
specified in this paragraph are the following:
(A) The Department of Health and Human Services, the
Department of Justice, the Department of Agriculture, and the
Department of Transportation.
(B) Any Federal agency to which information specified in
paragraph (1) is transferred by any agency specified in
subparagraph (A) of this paragraph.
(C) Any Federal agency that is a registered person, or has a
sub-agency component that is a registered person.
(D) Any Federal agency that awards grants or enters into
contracts or cooperative agreements involving listed agents and
toxins to or with a registered person, and to which information
specified in paragraph (1) is transferred by any such
registered person.
(3) Other exemptions
This subsection may not be construed as altering the
application of any exemptions to public disclosure under section
552 of title 5, except as to subsection (!2) 552(b)(3) of such
title, to any of the information specified in paragraph (1).
(4) Rule of construction
Except as specifically provided in paragraph (1), this
subsection may not be construed as altering the authority of any
Federal agency to withhold under section 552 of title 5, or the
obligation of any Federal agency to disclose under section 552 of
title 5, any information, including information relating to -
(A) listed agents and toxins, or individuals seeking access
to such agents and toxins;
(B) registered persons, or persons seeking to register their
possession, use, or transfer of such agents and toxins;
(C) general safeguard and security policies and requirements
under regulations under subsections (b) and (c) of this
section; or
(D) summary or statistical information concerning
registrations, registrants, denials or revocations of
registrations, listed agents and toxins, inspection evaluations
and reports, or individuals seeking access to such agents and
toxins.
(5) Disclosures to Congress; other disclosures
This subsection may not be construed as providing any authority
-
(A) to withhold information from the Congress or any
committee or subcommittee thereof; or
(B) to withhold information from any person under any other
Federal law or treaty.
(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) of this section 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 1320a-7a of this title (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 1320a-7a(a) of this title. The Secretary may
delegate authority under this subsection in the same manner as
provided in section 1320a-7a(j)(2) of this title, and such
authority shall include all powers as contained in section 6 of
the Inspector General Act of 1978 (5 U.S.C. App.).
(j) Notification in event of release
Regulations under subsections (b) and (c) of this section shall
require the prompt notification of the Secretary by a registered
person whenever a release, meeting criteria established by the
Secretary, of a listed agent or toxin has occurred outside of the
biocontainment area of a facility of the registered person. Upon
receipt of such notification and a finding by the Secretary that
the release poses a threat to public health or safety, the
Secretary shall take appropriate action to notify relevant State
and local public health authorities, other relevant Federal
authorities, and, if necessary, other appropriate persons
(including the public). If the released listed agent or toxin is an
overlap agent or toxin (as defined in subsection (l) of this
section), the Secretary shall promptly notify the Secretary of
Agriculture upon notification by the registered person.
(k) Reports
The Secretary shall report to the Congress annually on the number
and nature of notifications received under subsection (e)(8) of
this section (relating to theft or loss) and subsection (j) of this
section (relating to releases).
(l) 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.
(2) The term "listed agents and toxins" means biological agents
and toxins listed pursuant to subsection (a)(1) of this section.
(3) The term "listed agents or toxins" means biological agents
or toxins listed pursuant to subsection (a)(1) of this section.
(4) The term "overlap agents and toxins" means biological
agents and toxins that -
(A) are listed pursuant to subsection (a)(1) of this section;
and
(B) are listed pursuant to section 8401(a)(1) of title 7.
(5) The term "overlap agent or toxin" means a biological agent
or toxin that -
(A) is listed pursuant to subsection (a)(1) of this section;
and
(B) is listed pursuant to section 8401(a)(1) of title 7.
(6) The term "person" includes Federal, State, and local
governmental entities.
(7) The term "registered person" means a person registered
under regulations under subsection (b) or (c) of this section.
(8) The term "restricted person" has the meaning given such
term in section 175b of title 18.
(m) 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 2007.