---
kind: "section"
citation: "7 U.S.C. § 8401"
title: "7"
title_heading: "Agriculture"
number: "8401"
heading: "Regulation of certain biological agents and toxins"
release: "119-102"
url: "https://uscodex.org/usc/7/8401"
units:
  - "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](#l-7) of Agriculture shall by regulation establish and maintain a list of each [biological agent](#l-1) and each [toxin](#l-1) that the [Secretary](#l-7) determines has the potential to pose a severe threat to [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) health, or to [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) products.
    - (B) **Criteria—** In determining whether to include an agent or [toxin](#l-1) on the list under [subparagraph (A)](#a-1-A), the [Secretary](#l-7) shall—
      - (i) consider—
        - (I) the effect of exposure to the agent or [toxin](#l-1) on [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) health, and on the production and marketability of [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) products;
        - (II) the pathogenicity of the agent or the toxicity of the [toxin](#l-1) and the methods by which the agent or [toxin](#l-1) is transferred to [animals](/usc/7/8901.md?p=7) or [plants](/usc/7/8901.md?p=10);
        - (III) the availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or [toxin](#l-1);
        - (IV)
          - (aa) whether such inclusion would have a substantial negative impact on the research and development of solutions for the [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) disease caused by the agent or [toxin](#l-1); and
          - (bb) whether the negative impact described in [item (aa)](#a-1-B-i-IV-aa) would substantially outweigh the risk posed by the agent or [toxin](#l-1) to [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) health if it is not included on the list; and
        - (V) any other criteria that the [Secretary](#l-7) considers appropriate to protect [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) health, or [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) products; and
      - (ii) consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups.
  - (2) **Biennial review—** The [Secretary](#l-7) shall review and republish the list under [paragraph (1)](#a-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](#l-7) shall by regulation provide for—
  - (1) the establishment and enforcement of safety procedures for the transfer of [listed agents and toxins](#l-2), including measures to ensure—
    - (A) proper training and appropriate skills to handle such agents and [toxins](#l-1); and
    - (B) proper laboratory facilities to contain and dispose of such agents and [toxins](#l-1);
  - (2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and [toxins](#l-1) for use in domestic or international terrorism or for any other criminal purpose;
  - (3) the establishment of procedures to protect [animal](/usc/7/8901.md?p=7) and [plant](/usc/7/8901.md?p=10) health, and [animal](/usc/7/8901.md?p=7) and [plant](/usc/7/8901.md?p=10) products, in the event of a transfer or potential transfer of such an agent or [toxin](#l-1) in violation of the safety procedures established under [paragraph (1)](#b-1) or the safeguard and security measures established under [paragraph (2)](#b-2); and
  - (4) appropriate availability of [biological agents](#l-1) and [toxins](#l-1) for research, education, and other legitimate purposes.
- (c) **Possession and use of listed agents and toxins—** The [Secretary](#l-7) shall by regulation provide for the establishment and enforcement of standards and procedures governing the possession and use of [listed agents and toxins](#l-2), including the provisions described in [paragraphs (1) through (4)](#b-1..b-4) of subsection (b), in [order](/usc/7/2902.md?p=10) to protect [animal](/usc/7/8901.md?p=7) and [plant](/usc/7/8901.md?p=10) health, and [animal](/usc/7/8901.md?p=7) and [plant](/usc/7/8901.md?p=10) products.
- (d) **Registration; identification; database—**
  - (1) **Registration—** Regulations under subsections [(b)](#b) and [(c)](#c) shall require registration with the [Secretary](#l-7) of the possession, use, and transfer of [listed agents and toxins](#l-2), and shall include provisions to ensure that [persons](#l-5) seeking to register under such regulations have a lawful purpose to possess, use, or transfer such agents and [toxins](#l-1), including provisions in accordance with [subsection (e)(6)](#e-6).
  - (2) **Identification; database—** Regulations under subsections [(b)](#b) and [(c)](#c) shall require that registration include (if available to the [person](#l-5) registering) information regarding the characterization of [listed agents and toxins](#l-2) to facilitate their identification, including their source. The [Secretary](#l-7) shall maintain a national database that includes the names and locations of [registered persons](#l-6), the [listed agents and toxins](#l-2) such [persons](#l-5) are possessing, using, or transferring, and information regarding the characterization of such agents and [toxins](#l-1).
- (e) **Safeguard and security requirements for registered persons—**
  - (1) **In general—** Regulations under subsections [(b)](#b) and [(c)](#c) shall include appropriate safeguard and security requirements for [persons](#l-5) possessing, using, or transferring a listed agent or [toxin](#l-1) commensurate with the risk such agent or [toxin](#l-1) poses to [animal](/usc/7/8901.md?p=7) and [plant](/usc/7/8901.md?p=10) health, and [animal](/usc/7/8901.md?p=7) and [plant](/usc/7/8901.md?p=10) products (including the risk of use in domestic or international terrorism). The [Secretary](#l-7) shall establish such requirements in collaboration with the [Secretary](#l-7) 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)](#e-1) shall include provisions to ensure that [registered persons](#l-6)—
    - (A) provide access to [listed agents and toxins](#l-2) to only those individuals whom the [registered person](#l-6) involved determines have a legitimate need to handle or use such agents and [toxins](#l-1);
    - (B) submit the names and other identifying information for such individuals to the [Secretary](#l-7) and the Attorney General, promptly after first determining that the individuals need access under [subparagraph (A)](#e-2-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](#l-2) that are not [overlap agents and toxins](#g-1-A-ii-I) (as defined in [subsection (g)(1)(A)(ii)](#g-1-A-ii)), limit or deny access to such agents and [toxins](#l-1) by individuals whom the Attorney General has identified as within any category under [paragraph (3)(B)](#e-3-B), if limiting or denying such access by the individuals involved is determined appropriate by the [Secretary](#l-7), in consultation with the Attorney General; and
      - (ii) in the case of [listed agents and toxins](#l-2) that are overlap agents—
        - (I) deny access to such agents and [toxins](#l-1) by individuals whom the Attorney General has identified as within any category referred to in [paragraph (3)(B)(i)](#e-3-B-i); and
        - (II) limit or deny access to such agents and [toxins](#l-1) by individuals whom the Attorney General has identified as within any category under [paragraph (3)(B)(ii)](#e-3-B-ii), if limiting or denying such access by the individuals involved is determined appropriate by the [Secretary](#l-7), 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)](#e-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)](#e-3-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)](#e-3-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](/usc/18/175b.md?p=d-1) (relating to restricted [persons](#l-5)); 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](/usc/18/2332b.md?p=g-5);
        - (II) knowing involvement with an organization that engages in domestic or international terrorism (as defined in [section 2331](/usc/7/2331.md) 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](/usc/50/1801.md)).
    - (C) **Notification by Attorney General regarding submitted names—** After the receipt of a name and other identifying information under [paragraph (2)(B)](#e-2-B), the Attorney General shall promptly notify the [Secretary](#l-7) whether the individual is within any of the categories specified in [subparagraph (B)](#e-3-B).
  - (4) **Notifications by Secretary—** The [Secretary](#l-7), after receiving notice under [paragraph (3)](#e-3) regarding an individual, shall promptly notify the [registered person](#l-6) involved of whether the individual is granted or denied access under [paragraph (2)](#e-2). If the individual is denied such access, the [Secretary](#l-7) shall promptly notify the individual of the denial.
  - (5) **Expedited review—** Regulations under subsections [(b)](#b) and [(c)](#c) shall provide for a procedure through which, upon request to the [Secretary](#l-7) by a [registered person](#l-6) who submits names and other identifying information under [paragraph (2)(B)](#e-2-B) and who demonstrates good cause, the [Secretary](#l-7) may, as determined appropriate by the [Secretary](#l-7)—
    - (A) request the Attorney General to expedite the process of identification under [paragraph (3)(A)](#e-3-A) and notification of the [Secretary](#l-7) under [paragraph (3)(C)](#e-3-C); and
    - (B) expedite the notification of the [registered person](#l-6) by the [Secretary](#l-7) under [paragraph (4)](#e-4).
  - (6) **Process regarding persons seeking to register—**
    - (A) **Individuals—** Regulations under subsections [(b)](#b) and [(c)](#c) 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)](#e-2..e-4) as apply to names and other identifying information submitted to the Attorney General under [paragraph (2)(B)](#e-2-B). [Paragraph (5)](#e-5) does not apply for purposes of this subparagraph.
    - (B) **Other persons—** Regulations under subsections [(b)](#b) and [(c)](#c) shall provide that, in determining whether to deny or revoke registration by a [person](#l-5) other than an individual, the [Secretary](#l-7) shall submit the name of such [person](#l-5) 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](#l-7) whether the [person](#l-5), or, where relevant, the individual who owns or controls such [person](#l-5), is within any of the categories described in [section 175b(d)(1) of title 18](/usc/18/175b.md?p=d-1) (relating to restricted [persons](#l-5)), or is reasonably suspected by any Federal law enforcement or intelligence agency of being within any category specified in [paragraph (3)(B)(ii)](#e-3-B-ii) (as applied to [persons](#l-5), including individuals). Such regulations shall provide that a [person](#l-5) who seeks to register under either of such subsections is subject to the same processes described in paragraphs [(2)](#e-2) and [(4)](#e-4) as apply to names and other identifying information submitted to the Attorney General under [paragraph (2)(B)](#e-2-B). [Paragraph (5)](#e-5) does not apply for purposes of this subparagraph. The [Secretary](#l-7) may exempt Federal, [State](/usc/7/1359aa.md?p=5), or local governmental agencies from the requirements of this subparagraph.
  - (7) **Review—**
    - (A) **Administrative review—**
      - (i) **In general—** Regulations under subsections [(b)](#b) and [(c)](#c) shall provide for an opportunity for a review by the [Secretary](#l-7)—
        - (I) when requested by the individual involved, of a determination under [paragraph (2)](#e-2) to deny the individual access to [listed agents and toxins](#l-2); and
        - (II) when requested by the [person](#l-5) involved, of a determination under under[^1] [paragraph (6)](#e-6) to deny or revoke registration for such [person](#l-5).
      - (ii) **Ex parte review—** During a review under [clause (i)](#e-7-A-i), the [Secretary](#l-7) 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](#l-7) in a review under [clause (i)](#e-7-A-i) constitutes final agency action for purposes of [section 702 of title 5](/usc/5/702.md).
    - (B) **Certain procedures—**
      - (i) **Submission of ex parte materials in judicial proceedings—** When reviewing a decision of the [Secretary](#l-7) under [subparagraph (A)](#e-7-A), and upon request made ex parte and in writing by the [United States](/usc/7/6402.md?p=8), 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](#l-5) involved to allow a response, the court shall authorize the [United States](/usc/7/6402.md?p=8) 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](#l-5) may respond. Any [order](/usc/7/2902.md?p=10) by the court authorizing the disclosure of information that the [United States](/usc/7/6402.md?p=8) 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](/usc/18/2339B.md?p=f-5) (relating to interlocutory appeal and expedited consideration).
      - (ii) **Disclosure of information—** In a review under [subparagraph (A)](#e-7-A), and in any judical[^2] proceeding conducted pursuant to such review, neither the [Secretary](#l-7) nor the Attorney General may be required to disclose to the public any information that under [subsection (h)](#h) shall not be disclosed under [section 552 of title 5](/usc/5/552.md).
  - (8) **Notifications regarding theft or loss of agents—** Requirements under [paragraph (1)](#e-1) shall include the prompt notification of the [Secretary](#l-7), and appropriate Federal, [State](/usc/7/1359aa.md?p=5), and local law enforcement agencies, of the theft or loss of [listed agents and toxins](#l-2).
  - (9) **Technical assistance for registered persons—** The [Secretary](#l-7), in consultation with the Attorney General, may provide technical assistance to [registered persons](#l-6) to improve security of the facilities of such [persons](#l-5).
- (f) **Inspections—** The [Secretary](#l-7) shall have the [authority](/usc/7/2009aa.md?p=1) to inspect [persons](#l-5) subject to regulations under subsection [(b)](#b) or [(c)](#c) to ensure their compliance with such regulations, including prohibitions on restricted [persons](#l-5) and other provisions of [subsection (e)](#e).
- (g) **Exemptions—**
  - (1) **Overlap agents and toxins—**
    - (A) **In general—**
      - (i) **Limitation—** In the case of [overlap agents and toxins](#l-4), exemptions from the applicability of provisions of regulations under subsection [(b)](#b) or [(c)](#c) 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](#l-4)” means [biological agents](#l-1) and [toxins](#l-1) that—
          - (aa) are listed pursuant to [subsection (a)(1)](#a-1); and
          - (bb) are listed pursuant to [section 262a(a)(1) of title 42](/usc/42/262a.md?p=a-1).[^3]
        - (II) The term “[overlap agent or toxin](#l-4)” means a [biological agent](#l-1) or [toxin](#l-1) that—
          - (aa) is listed pursuant to [subsection (a)(1)](#a-1); and
          - (bb) is listed pursuant to [section 262a(a)(1) of title 42](/usc/42/262a.md?p=a-1).[^3]
    - (B) **Clinical or diagnostic laboratories—** Regulations under subsections [(b)](#b) and [(c)](#c) shall exempt clinical or diagnostic laboratories and other [persons](#l-5) who possess, use, or transfer overlap agents or [toxins](#l-1) that are contained in specimens presented for diagnosis, verification, or proficiency testing, provided that—
      - (i) the identification of such agents or [toxins](#l-1) is reported to the [Secretary](#l-7), and when required under Federal, [State](/usc/7/1359aa.md?p=5), or local law, to other appropriate [authorities](/usc/7/2009aa.md?p=1); and
      - (ii) such agents or [toxins](#l-1) are transferred or destroyed in a manner set forth by the [Secretary](#l-7) by regulation.
    - (C) **Products—**
      - (i) **In general—** Regulations under subsections [(b)](#b) and [(c)](#c) shall exempt products that are, bear, or contain overlap agents or [toxins](#l-1) and are cleared, approved, licensed, or registered under any of the Acts specified in [clause (ii)](#g-1-C-ii), unless the [Secretary](#l-7) by [order](/usc/7/2902.md?p=10) determines that applying additional regulation under subsection [(b)](#b) or [(c)](#c) to a specific product is necessary to protect [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) health, or [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) products.
      - (ii) **Relevant laws—** For purposes of [clause (i)](#g-1-C-i), the Acts specified in this clause are the following:
        - (I) The Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.].
        - (II) Section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)].
        - (III) The Act commonly known as the Virus-Serum-Toxin Act (the eighth paragraph under the heading “Bureau of [Animal](/usc/7/8901.md?p=7) Industry” in the Act of March 4, 1913; [21 U.S.C. 151–159](https://uscode.house.gov/view.xhtml?req=(/us/usc/t21/s151–159))).
        - (IV) The Federal Insecticide, Fungicide, and Rodenticide Act [[7 U.S.C. 136](/usc/7/136.md) et seq.].
      - (iii) **Investigational use—**
        - (I) **In general—** The [Secretary](#l-7) may exempt an investigational product that is, bears, or contains an [overlap agent or toxin](#l-4) from the applicability of provisions of regulations under subsection [(b)](#b) or [(c)](#c) when such product is being used in an investigation authorized under any Federal Act and the [Secretary](#l-7) determines that applying additional regulation under subsection [(b)](#b) or [(c)](#c) to such product is not necessary to protect [animal](/usc/7/8901.md?p=7) and [plant](/usc/7/8901.md?p=10) health, and [animal](/usc/7/8901.md?p=7) and [plant](/usc/7/8901.md?p=10) products.
        - (II) **Certain processes—** Regulations under subsections [(b)](#b) and [(c)](#c) shall set forth the procedures for applying for an exemption under [subclause (I)](#g-1-C-iii-I). In the case of investigational products authorized under any of the Acts specified in [clause (ii)](#g-1-C-ii), the [Secretary](#l-7) 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](#l-5) requesting the exemption:
          - (aa) The [person](#l-5) has submitted to the [Secretary](#l-7) an application for the exemption meeting the requirements established by the [Secretary](#l-7).
          - (bb) The [person](#l-5) has notified the [Secretary](#l-7) that the investigation has been authorized under such an Act.
    - (D) **Agricultural emergencies—** The [Secretary](#l-7) may temporarily exempt a [person](#l-5) from the applicability of the requirements of this section with respect to an [overlap agent or toxin](#l-4), in whole or in part, if the [Secretary](#l-7) determines that such exemption is necessary to provide for the timely participation of the [person](#l-5) in a response to a domestic or foreign agricultural emergency that involves such an agent or [toxin](#l-1). With respect to the emergency involved, the exemption under this subparagraph for a [person](#l-5) may not exceed 30 days, except that the [Secretary](#l-7), after review of whether such exemption remains necessary, may provide one [extension](/usc/7/5801.md?p=b-5) of an additional 30 days.
    - (E) **Public health emergencies—** Upon request of the [Secretary](#l-7) of Health and Human Services, after the granting by such [Secretary](#l-7) of an exemption under 262a(g)(3)[^4] of title 42 pursuant to a finding that there is a public health emergency, the [Secretary](#l-7) of Agriculture may temporarily exempt a [person](#l-5) from the applicability of the requirements of this section with respect to an [overlap agent or toxin](#l-4), in whole or in part, to provide for the timely participation of the [person](#l-5) in a response to the public health emergency. With respect to the emergency involved, such exemption for a [person](#l-5) may not exceed 30 days, except that upon request of the [Secretary](#l-7) of Health and Human Services, the [Secretary](#l-7) of Agriculture may, after review of whether such exemption remains necessary, provide one [extension](/usc/7/5801.md?p=b-5) of an additional 30 days.
  - (2) **General authority for exemptions not involving overlap agents or toxins—** In the case of [listed agents or toxins](#l-3) that are not overlap agents or [toxins](#l-1), the [Secretary](#l-7) may grant exemptions from the applicability of provisions of regulations under subsection [(b)](#b) or [(c)](#c) if the [Secretary](#l-7) determines that such exemptions are consistent with protecting [animal](/usc/7/8901.md?p=7) and [plant](/usc/7/8901.md?p=10) health, and [animal](/usc/7/8901.md?p=7) and [plant](/usc/7/8901.md?p=10) products.
- (h) **Disclosure of information—**
  - (1) **Nondisclosure of certain information—** No Federal agency specified in [paragraph (2)](#h-2) shall disclose under [section 552 of title 5](/usc/5/552.md) any of the following:
    - (A) Any registration or transfer documentation submitted under subsections [(b)](#b) and [(c)](#c), or permits issued prior to June 12, 2002, for the possession, use or transfer of a listed agent or [toxin](#l-1); or information derived therefrom to the extent that it identifies the listed agent or [toxin](#l-1) possessed, used or transferred by a specific [person](#l-5) or discloses the identity or location of a specific [person](#l-5).
    - (B) The national database developed pursuant to [subsection (d)](#d), or any other compilation of the registration or transfer information submitted under subsections [(b)](#b) and [(c)](#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](#l-6) to prevent unauthorized access to [listed agents and toxins](#l-2).
    - (D) Any notification of a release of a listed agent or [toxin](#l-1) submitted under subsections [(b)](#b) and [(c)](#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](#l-6) conducted under [subsection (f)](#f) that identifies the listed agent or [toxin](#l-1) possessed by a specific [registered person](#l-6) or that discloses the identity or location of a specific [registered person](#l-6) if the agency determines that public disclosure of the information would endanger [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) health, or [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) products.
  - (2) **Covered agencies—** For purposes of [paragraph (1)](#h-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)](#h-1) is transferred by any agency specified in subparagraph (A) of this paragraph.
    - (C) Any Federal agency that is a [registered person](#l-6), or has a sub-agency component that is a [registered person](#l-6).
    - (D) Any Federal agency that awards grants or enters into [contracts](/usc/7/518.md?p=4) or cooperative agreements involving [listed agents and toxins](#l-2) to or with a [registered person](#l-6), and to which information specified in [paragraph (1)](#h-1) is transferred by any such [registered person](#l-6).
  - (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](/usc/5/552.md), except as to subsection[^5] 552(b)(3) of such title, to any of the information specified in [paragraph (1)](#h-1).
  - (4) **Rule of construction—** Except as specifically provided in [paragraph (1)](#h-1), this subsection may not be construed as altering the [authority](/usc/7/2009aa.md?p=1) of any Federal agency to withhold under [section 552 of title 5](/usc/5/552.md), or the obligation of any Federal agency to disclose under [section 552 of title 5](/usc/5/552.md), any information, including information relating to—
    - (A) [listed agents and toxins](#l-2), or individuals seeking access to such agents and [toxins](#l-1);
    - (B) [registered persons](#l-6), or [persons](#l-5) seeking to register their possession, use, or transfer of such agents and [toxins](#l-1);
    - (C) general safeguard and security policies and requirements under regulations under subsections [(b)](#b) and [(c)](#c); or
    - (D) summary or statistical information concerning registrations, registrants, denials or revocations of registrations, [listed agents and toxins](#l-2), inspection evaluations and reports, or individuals seeking access to such agents and [toxins](#l-1).
  - (5) **Disclosures to Congress; other disclosures—** This subsection may not be construed as providing any [authority](/usc/7/2009aa.md?p=1)—
    - (A) to withhold information from the Congress or any [committee](/usc/7/2132.md?p=n) or subcommittee thereof; or
    - (B) to withhold information from any [person](#l-5) 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](#l-5) who violates any provision of regulations under subsection [(b)](#b) or [(c)](#c) shall be subject to the [United States](/usc/7/6402.md?p=8) 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](#l-5).
  - (2) **Applicability of certain provisions—** The provisions of sections 423 and 425(2) of the [Plant](/usc/7/8901.md?p=10) Protection Act ([7 U.S.C. 7733](/usc/7/7733.md) and 7735(2)) shall apply to a civil money penalty or activity under [paragraph (1)](#i-1) in the same manner as such provisions apply to a penalty or activity under the [Plant](/usc/7/8901.md?p=10) Protection Act [[7 U.S.C. 7701](/usc/7/7701.md) et seq.].
- (j) **Notification in event of release—** Regulations under subsections [(b)](#b) and [(c)](#c) shall require the prompt notification of the [Secretary](#l-7) by a [registered person](#l-6) whenever a release, meeting criteria established by the [Secretary](#l-7), of a listed agent or [toxin](#l-1) has occurred outside of the biocontainment [area](/usc/7/1471.md?p=5) of a facility of the [registered person](#l-6). Upon receipt of such notification and a finding by the [Secretary](#l-7) that the release poses a threat to [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) health, or [animal](/usc/7/8901.md?p=7) or [plant](/usc/7/8901.md?p=10) products, the [Secretary](#l-7) shall take appropriate action to notify relevant Federal, [State](/usc/7/1359aa.md?p=5), and local [authorities](/usc/7/2009aa.md?p=1), and, if necessary, other appropriate [persons](#l-5) (including the public). If the released listed agent or [toxin](#l-1) is an [overlap agent or toxin](#g-1-A-ii-II), the [Secretary](#l-7) shall promptly notify the [Secretary](#l-7) of Health and Human Services upon notification by the [registered person](#l-6).
- (k) **Reports—** The [Secretary](#l-7) shall report to the Congress annually on the number and nature of notifications received under [subsection (e)(8)](#e-8) (relating to theft or loss) and [subsection (j)](#j) (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](/usc/18/178.md).
  - (2) The term “listed agents and toxins” means [biological agents](#l-1) and [toxins](#l-1) listed pursuant to [subsection (a)(1)](#a-1).
  - (3) The term “listed agents or toxins” means [biological agents](#l-1) or [toxins](#l-1) listed pursuant to [subsection (a)(1)](#a-1).
  - (4) The terms “[overlap agents and toxins](#g-1-A-ii-I)” and “[overlap agent or toxin](#g-1-A-ii-II)” have the meaning given such terms in [subsection (g)(1)(A)(ii)](#g-1-A-ii).
  - (5) The term “person” includes Federal, [State](/usc/7/1359aa.md?p=5), and local governmental entities.
  - (6) The term “registered person” means a [person](#l-5) registered under regulations under subsection [(b)](#b) or [(c)](#c).
  - (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](/usc/7/4531.md?p=5) that may be available.

## Footnotes

[^1]: So in original.
[^2]: So in original. Probably should be “judicial”.
[^3]: See References in Text note below.
[^4]: So in original. Probably should be preceded by “section”.
[^5]: So in original. Probably should be “section”.

## Source credit

(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.)

## Notes

### Editorial Notes

### 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, 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, 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, Oct. 21, 1972, 86 Stat. 973, which is classified generally to subchapter II (§ 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, which is classified principally to chapter 104 (§ 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

2018—Subsec. (a)(1)(B)(i)(IV), (V). Pub. L. 115–334 added subcl. (IV) and redesignated former subcl. (IV) as (V).

2002—Subsec. (e)(1). Pub. L. 107–296 substituted “collaboration with the Secretary of Homeland Security and” for “consultation with”.

### Statutory Notes and Related Subsidiaries

### 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, § 211, June 12, 2002, 116 Stat. 647, provided that: “This subtitle [subtitle B (§§ 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, § 213, June 12, 2002, 116 Stat. 656, provided that: 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 (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. 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. 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— section 175b(c) of title 18, United States Code (relating to criminal penalties), as added by section 231(a)(5) of this Act; and section 212(i) of this Act [7 U.S.C. 8401(i)] (relating to civil penalties). 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.”