 |
United States Code (Last Updated: May 24, 2014) |
 |
Title 7. AGRICULTURE |
|
Chapter 110. ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS |
|
SubChapter I. DEPARTMENT OF AGRICULTURE |
§ 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 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 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 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 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.
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 (§ 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 (§ 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,
The Plant Protection Act, referred to in subsec. (i)(2), is title IV of Pub. L. 106–224,
Amendments
2002—Subsec. (e)(1). Pub. L. 107–296 substituted “collaboration with the Secretary of Homeland Security and” for “consultation with”.
Effective Date Of Amendment
Amendment by Pub. L. 107–296 effective 60 days after
Short Title
Pub. L. 107–188, title II, § 211,
Miscellaneous
Pub. L. 107–188, title II, § 213,