USC - Regulation of certain biological agents and toxins

View all text of Subchapter I [§ 8401 - § 8401]

§ 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

(B) CriteriaIn 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;(IV)(aa) whether such inclusion would have a substantial negative impact on the research and development of solutions for the animal or plant disease caused by the agent or toxin; and(bb) whether the negative impact described in item (aa) would substantially outweigh the risk posed by the agent or toxin to animal or plant health if it is not included on the list; and(V) 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

(b) Regulation of transfers of listed agents and toxinsThe Secretary shall by regulation provide for—

(1)

(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.

(d) Registration; identification; database

(1) Registration

(2) Identification; database

(e) Safeguard and security requirements for registered persons

(1) In general

(2) Limiting access to listed agents and toxinsRequirements 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)), 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

(B) Certain individualsFor 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).

(4) Notifications by Secretary

(5) Expedited reviewRegulations 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

(B) Other persons

(7) Review

(A) Administrative review

(i) In generalRegulations 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 under 1

1 So in original.

paragraph (6) to deny or revoke registration for such person.

(ii) Ex parte review

(iii) Final agency action

(B) Certain procedures

(i) Submission of ex parte materials in judicial proceedings

(ii) Disclosure of information

(8) Notifications regarding theft or loss of agents

(9) Technical assistance for registered persons

(f) Inspections

(g) Exemptions

(1) Overlap agents and toxins

(A) In general

(i) Limitation

(ii) DefinitionsFor 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); and(bb) are listed pursuant to section 262a(a)(1) of title 42. 3

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); and(bb) is listed pursuant to section 262a(a)(1) of title 42. 3

(B) Clinical or diagnostic laboratoriesRegulations under subsections (b) and (c) 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.

(i) In general

(ii) Relevant lawsFor 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 span “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(II) Certain processesRegulations under subsections (b) and (c) 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

(E) Public health emergencies

(2) General authority for exemptions not involving overlap agents or toxins

(h) Disclosure of information

(1) Nondisclosure of certain informationNo 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), 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), or any other compilation of the registration or transfer information submitted under subsections (b) and (c) 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), 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) 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 agenciesFor 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.

(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

(4) Rule of constructionExcept 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;

(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 disclosuresThis 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

(2) Applicability of certain provisions

(j) Notification in event of release

(k) Reports

(l) DefinitionsFor 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).

(3) The term “listed agents or toxins” means biological agents or toxins listed pursuant to subsection (a)(1).

(4) The terms “overlap agents and toxins” and “overlap agent or toxin” have the meaning given such terms in subsection (g)(1)(A)(ii).

(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).

(7) The term “Secretary” means the Secretary of Agriculture.

(m) Authorization of appropriations

(Pub. L. 107–188, title II, § 212, June 12, 2002, 116 Stat. 647; Pub. L. 107–296, title XVII, § 1709(b), Nov. 25, 2002, 116 Stat. 2319; Pub. L. 115–334, title XII, § 12204, Dec. 20, 2018, 132 Stat. 4949.)