7 USC 8401: Information concerning select agents and toxins
About This Project
This project uses data compiled by the Sunshine in Government initiative, a coalition of journalism and transparency groups. SGI compiled data from federal agency annual FOIA reports to track how often b(3) exemptions were used. SGI also standardized the exemptions since some agencies used slightly different citations of the same laws. In some cases, agencies listed general laws without specifying a section under which information was withheld. This project does not include information from agencies that use no b(3) exemptions in 2008 or 2009. ProPublica compiled information about FOIA denials.
| Department | Claims |
|---|---|
| Dept. of Agriculture | 2.0 |
TITLE 7--AGRICULTURE
CHAPTER 110--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND
TOXINS
SUBCHAPTER I--DEPARTMENT OF AGRICULTURE
Sec. 8401. Regulation of certain 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 of Agriculture shall by regulation establish
and maintain a list of each biological agent and each toxin that
the Secretary determines has the potential to pose a severe
threat to animal or plant health, or to animal or plant
products.
(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 of exposure to the agent or toxin on
animal or plant health, and on the production and
marketability of animal or plant products;
(II) the pathogenicity of the agent or the toxicity
of the toxin and the methods by which the agent or toxin
is transferred to animals or plants;
(III) the availability and effectiveness of
pharmacotherapies and prophylaxis to treat and prevent
any illness caused by the agent or toxin; and
(IV) any other criteria that the Secretary considers
appropriate to protect animal or plant health, or animal
or plant products; and
(ii) consult with appropriate Federal departments and
agencies and with scientific experts representing
appropriate professional groups.
(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 animal and plant
health, and animal and plant products, in the event of a transfer or
potential transfer of such an agent or toxin in
[[Page 1724]]
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 animal and plant health, and animal and plant products.
(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 animal and
plant health, and animal and plant products (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; and
(C)(i) in the case of listed agents and toxins that are not
overlap agents and toxins (as defined in subsection
(g)(1)(A)(ii) of this section), 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), if
limiting or denying such access by the individuals involved is
determined appropriate by the Secretary, in consultation with
the Attorney General; and
(ii) in the case of listed agents and toxins that are
overlap agents--
(I) deny access to such agents and toxins by individuals
whom the Attorney General has identified as within any
category referred to in paragraph (3)(B)(i); and
(II) 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 within any of the categories
described in section 175b(d)(1) of title 18 (relating to
restricted persons); 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
[[Page 1725]]
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 within any of the
categories described in section 175b(d)(1) of title 18 (relating
to restricted persons), 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 under \1\ paragraph (6) to deny or
revoke registration for such person.
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\1\ So in original.
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(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
\2\ proceeding conducted pursuant to such review, neither
the Secretary nor the Attorney General may be
[[Page 1726]]
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.
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\2\ So in original. Probably should be ``judicial''.
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(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) Overlap agents and toxins
(A) In general
(i) Limitation
In the case of overlap agents and toxins, exemptions
from the applicability of provisions of regulations under
subsection (b) or (c) of this section may be granted only to
the extent provided in this paragraph.
(ii) Definitions
For purposes of this section:
(I) The term ``overlap agents and toxins'' means
biological agents and toxins that--
(aa) are listed pursuant to subsection (a)(1) of
this section; and
(bb) are listed pursuant to section 262a(a)(1)
of title 42. \3\
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\3\ See References in Text note below.
(II) The term ``overlap agent or toxin'' means a
biological agent or toxin that--
(aa) is listed pursuant to subsection (a)(1) of
this section; and
(bb) is listed pursuant to section 262a(a)(1) of
title 42. \3\
(B) 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 overlap agents or toxins
that are contained in specimens presented for diagnosis,
verification, or proficiency testing, provided that--
(i) 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
(ii) such agents or toxins are transferred or destroyed
in a manner set forth by the Secretary by regulation.
(C) Products
(i) In general
Regulations under subsections (b) and (c) of this
section shall exempt products that are, bear, or contain
overlap agents or toxins and are cleared, approved,
licensed, or registered under any of the Acts specified in
clause (ii), 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 animal or plant health, or animal or plant products.
(ii) Relevant laws
For purposes of clause (i), the Acts specified in this
clause are the following:
(I) The Federal Food, Drug, and Cosmetic Act [21
U.S.C. 301 et seq.].
(II) Section 351 of the Public Health Service Act
[42 U.S.C. 262].
(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.].
(iii) Investigational use
(I) In general
The Secretary may exempt an investigational product
that is, bears, or contains an overlap 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 animal and plant health, and animal and plant
products.
(II) Certain processes
Regulations under subsections (b) and (c) of this
section shall set forth the procedures for applying for
an exemption under subclause (I). In the case of
investigational products authorized under any of the
Acts specified in clause (ii), 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:
(aa) The person has submitted to the Secretary
an application for the exemption meeting the
requirements established by the Secretary.
(bb) The person has notified the Secretary that
the investigation has been authorized under such an
Act.
(D) Agricultural emergencies
The Secretary may temporarily exempt a person from the
applicability of the requirements of this section with respect
to an
[[Page 1727]]
overlap agent or toxin, 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 agricultural emergency that involves such an agent or
toxin. With respect to the emergency involved, the exemption
under this subparagraph 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.
(E) Public health emergencies
Upon request of the Secretary of Health and Human Services,
after the granting by such Secretary of an exemption under
262a(g)(3) \4\ of title 42 pursuant to a finding that there is a
public health emergency, the Secretary of Agriculture may
temporarily exempt a person from the applicability of the
requirements of this section with respect to an overlap agent or
toxin, in whole or in part, to provide for the timely
participation of the person in a response to the public health
emergency. With respect to the emergency involved, such
exemption for a person may not exceed 30 days, except that upon
request of the Secretary of Health and Human Services, the
Secretary of Agriculture may, after review of whether such
exemption remains necessary, provide one extension of an
additional 30 days.
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\4\ So in original. Probably should be preceded by ``section''.
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(2) General authority for exemptions not involving overlap
agents or toxins
In the case of listed agents or toxins that are not overlap
agents or toxins, the Secretary may grant exemptions from the
applicability of provisions of regulations under subsection (b) or
(c) of this section if the Secretary determines that such exemptions
are consistent with protecting animal and plant health, and animal
and plant products.
(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, or permits issued
prior to June 12, 2002, 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 person or discloses the
identity or location of a specific 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 animal or plant health, or animal or plant
products.
(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 \5\ 552(b)(3) of such title, to any of the
information specified in paragraph (1).
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\5\ So in original. Probably should be ``section''.
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(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.
[[Page 1728]]
(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 sections 423 and 425(2) of the Plant
Protection Act (7 U.S.C. 7733 and 7735(2)) shall apply to a civil
money penalty or activity under paragraph (1) in the same manner as
such provisions apply to a penalty or activity under the Plant
Protection Act [7 U.S.C. 7701 et seq.].
(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 animal
or plant health, or animal or plant products, the Secretary shall take
appropriate action to notify relevant Federal, State, and local
authorities, and, if necessary, other appropriate persons (including the
public). If the released listed agent or toxin is an overlap agent or
toxin, the Secretary shall promptly notify the Secretary of Health and
Human Services 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 terms ``overlap agents and toxins'' and ``overlap agent
or toxin'' have the meaning given such terms in subsection
(g)(1)(A)(ii) of this section.
(5) The term ``person'' includes Federal, State, and local
governmental entities.
(6) The term ``registered person'' means a person registered
under regulations under subsection (b) or (c) of this section.
(7) The term ``Secretary'' means the Secretary of Agriculture.
(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, in addition to other funds that may be
available.
(Pub. L. 107-188, title II, Sec. 212, June 12, 2002, 116 Stat. 647; Pub.
L. 107-296, title XVII, Sec. 1709(b), Nov. 25, 2002, 116 Stat. 2319.)
References in Text
Section 262a(a)(1) of title 42, referred to in subsec.
(g)(1)(A)(ii), was in the original ``section 315A(a)(1) of the Public
Health Service Act'', and was translated as meaning section 351A(a)(1)
of that Act to reflect the probable intent of Congress, because the
Public Health Service Act does not contain a section 315A and section
351A refers to a list of biological agents and toxins.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(g)(1)(C)(ii)(I), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et seq.)
of Title 21, Food and Drugs. For complete classification of this Act to
the Code, see section 301 of Title 21 and Tables.
The Act commonly known as the Virus-Serum-Toxin Act, referred to in
subsec. (g)(1)(C)(ii)(III), is the eighth paragraph under the heading
``Bureau of Animal Industry'' of act Mar. 4, 1913, ch. 145, 37 Stat.
832, as amended, which is classified generally to chapter 5 (Sec. 151 et
seq.) of Title 21, Food and Drugs. For complete classification of this
Act to the Code, see Short Title note set out under section 151 of Title
21 and Tables.
The Federal Insecticide, Fungicide, and Rodenticide Act, referred
to in subsec. (g)(1)(C)(ii)(IV), is act June 25, 1947, ch. 125, as
amended generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which
is classified generally to subchapter II (Sec. 136 et seq.) of chapter 6
of this title. For complete classification of this Act to the Code, see
Short Title note set out under section 136 of this title and Tables.
The Plant Protection Act, referred to in subsec. (i)(2), is title IV
of Pub. L. 106-224, June 20, 2000, 114 Stat. 438, as amended, which is
classified principally to chapter 104 (Sec. 7701 et seq.) of this title.
For complete classification of this Act to the Code, see Short Title
note set out under section 7701 of this title and Tables.
Amendments
2002--Subsec. (e)(1). Pub. L. 107-296 substituted ``collaboration
with the Secretary of Homeland Security and'' for ``consultation with''.
Effective Date of 2002 Amendment
Amendment by Pub. L. 107-296 effective 60 days after Nov. 25, 2002,
see section 4 of Pub. L. 107-296, set out as an Effective Date note
under section 101 of Title 6, Domestic Security.
Short Title
Pub. L. 107-188, title II, Sec. 211, June 12, 2002, 116 Stat. 647,
provided that: ``This subtitle [subtitle B (Secs. 211-213) of title
II of Pub. L. 107-188, enacting this subchapter] may be cited as the
`Agricultural Bioterrorism Protection Act of 2002'.''
Implementation by Department of Agriculture
Pub. L. 107-188, title II, Sec. 213, June 12, 2002, 116 Stat. 656,
provided that:
``(a) Date Certain for Promulgation of List.--Not later than 60 days
after the date of the enactment of this Act [June 12, 2002], the
Secretary of Agriculture
[[Page 1729]]
(referred to in this section as the `Secretary') shall promulgate an
interim final rule that establishes the initial list under section
212(a)(1) [7 U.S.C. 8401(a)(1)]. In promulgating such rule, the
Secretary shall provide written guidance on the manner in which the
notice required in subsection (b) is to be provided to the Secretary.
``(b) Date Certain for Notice of Possession.--Not later than 60 days
after the date on which the Secretary promulgates the interim final rule
under subsection (a), all persons (unless exempt under section 212(g) [7
U.S.C. 8401(g)]) in possession of biological agents or toxins included
on the list referred to in subsection (a) shall notify the Secretary of
such possession.
``(c) Date Certain for Promulgation; Effective Date Regarding
Criminal and Civil Penalties.--Not later than 180 days after the date of
the enactment of this Act [June 12, 2002], the Secretary shall
promulgate an interim final rule for carrying out section 212 [7 U.S.C.
8401], other than for the list referred to in subsection (a) of this
section (but such rule may incorporate by reference provisions
promulgated pursuant to subsection (a)). Such interim final rule shall
take effect 60 days after the date on which such rule is promulgated,
including for purposes of--
``(1) section 175b(c) of title 18, United States Code (relating
to criminal penalties), as added by section 231(a)(5) of this Act;
and
``(2) section 212(i) of this Act [7 U.S.C. 8401(i)] (relating to
civil penalties).
``(d) Transitional Provision Regarding Current Research and
Education.--The interim final rule under subsection (c) shall include
time frames for the applicability of the rule that minimize disruption
of research or educational projects that involve biological agents and
toxins listed pursuant to section 212(a)(1) [7 U.S.C. 8401(a)(1)] and
that were underway as of the effective date of such rule.''