42 U.S.C. § 262a (THE PUBLIC HEALTH AND WELFARE)
§ 262a. Enhanced control of dangerous biological agents and toxins
(a) Regulatory control of certain biological agents and toxins
(1) List of biological agents and toxins
(A) In general
The Secretary shall by regulation establish and maintain a list of each biological agent and each toxin that has the potential to pose a severe threat to public health and safety.
(B) Criteria
In determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall—
(i) consider—
(I) the effect on human health of exposure to the agent or toxin;
(II) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;
(III) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and
(IV) any other criteria, including the needs of children and other vulnerable populations, that the Secretary considers appropriate; and
(ii) consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups, including groups with pediatric expertise.
(2) Biennial review
The Secretary shall review and republish the list under paragraph (1) biennially, or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph.
(b) Regulation of transfers of listed agents and toxins
The Secretary shall by regulation provide for—
(1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure—
(A) proper training, including with respect to notification requirements under this section, of—
(i) individuals who are involved in the handling and use of such agents and toxins, including appropriate skills to handle such agents and toxins;
(ii) individuals whose responsibilities routinely place them in close proximity to laboratory facilities in which such agents and toxins are being transferred, possessed, or used; and
(iii) individuals who perform administrative or oversight functions of the facility related to the transfer, possession, or use of such agents and toxins on behalf of registered persons;
(B) proper laboratory facilities to contain and dispose of such agents and toxins;
(2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose;
(3) the establishment of procedures to protect the public safety in the event of a transfer or potential transfer of such an agent or toxin in violation of the safety procedures established under paragraph (1) or the safeguard and security measures established under paragraph (2); and
(4) appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.
(c) Possession and use of listed agents and toxins
The Secretary shall by regulation provide for the establishment and enforcement of standards and procedures governing the possession and use of listed agents and toxins, including the provisions described in paragraphs (1) through (4) of subsection (b), in order to protect the public health and safety.
(d) Registration; identification; database
(1) Registration
Regulations under subsections (b) and (c) 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).
(2) Identification; database
Regulations under subsections (b) and (c) 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) shall include appropriate safeguard and security requirements for persons possessing, using, or transferring a listed agent or toxin commensurate with the risk such agent or toxin poses to public health and safety (including risks posed by the release, theft, or loss of such agent or toxin, or use in domestic or international terrorism). The Secretary shall establish such requirements in collaboration with the Secretary of Homeland Security and the Attorney General, and shall ensure compliance with such requirements as part of the registration system under such regulations.
(2) Limiting access to listed agents and toxins
Requirements under paragraph (1) shall include provisions to ensure that registered persons—
(A) provide access to listed agents and toxins to only those individuals whom the registered person involved determines have a legitimate need to handle or use such agents and toxins;
(B) submit the names and other identifying information for such individuals to the Secretary and the Attorney General, promptly after first determining that the individuals need access under subparagraph (A), and periodically thereafter while the individuals have such access, not less frequently than once every five years;
(C) deny access to such agents and toxins by individuals whom the Attorney General has identified as restricted persons; and
(D) limit or deny access to such agents and toxins by individuals whom the Attorney General has identified as within any category under paragraph (3)(B)(ii), if limiting or denying such access by the individuals involved is determined appropriate by the Secretary, in consultation with the Attorney General.
(3) Submitted names; use of databases by attorney general
(A) In general
Upon the receipt of names and other identifying information under paragraph (2)(B), the Attorney General shall, for the sole purpose of identifying whether the individuals involved are within any of the categories specified in subparagraph (B), promptly use criminal, immigration, national security, and other electronic databases that are available to the Federal Government and are appropriate for such purpose.
(B) Certain individuals
For purposes of subparagraph (A), the categories specified in this subparagraph regarding an individual are that—
(i) the individual is a restricted person; or
(ii) the individual is reasonably suspected by any Federal law enforcement or intelligence agency of—
(I) committing a crime set forth in section 2332b(g)(5) of title 18;
(II) knowing involvement with an organization that engages in domestic or international terrorism (as defined in section 2331 of such title 18) or with any other organization that engages in intentional crimes of violence; or
(III) being an agent of a foreign power (as defined in section 1801 of title 50).
(C) Notification by Attorney General regarding submitted names
After the receipt of a name and other identifying information under paragraph (2)(B), the Attorney General shall promptly notify the Secretary whether the individual is within any of the categories specified in subparagraph (B).
(4) Notifications by Secretary
The Secretary, after receiving notice under paragraph (3) regarding an individual, shall promptly notify the registered person involved of whether the individual is granted or denied access under paragraph (2). If the individual is denied such access, the Secretary shall promptly notify the individual of the denial.
(5) Expedited review
Regulations under subsections (b) and (c) 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) 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) shall provide that, in determining whether to deny or revoke registration by a person other than an individual, the Secretary shall submit the name of such person to the Attorney General, who shall use criminal, immigration, national security, and other electronic databases available to the Federal Government, as appropriate for the purpose of promptly notifying the Secretary whether the person, or, where relevant, the individual who owns or controls such person, is a restricted person or is reasonably suspected by any Federal law enforcement or intelligence agency of being within any category specified in paragraph (3)(B)(ii) (as applied to persons, including individuals). Such regulations shall provide that a person who seeks to register under either of such subsections is subject to the same processes described in paragraphs (2) and (4) as apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B). Paragraph (5) does not apply for purposes of this subparagraph. The Secretary may exempt Federal, State, or local governmental agencies from the requirements of this subparagraph.
(7) Review
(A) Administrative review
(i) In general
Regulations under subsections (b) and (c) shall provide for an opportunity for a review by the Secretary—
(I) when requested by the individual involved, of a determination under paragraph (2) to deny the individual access to listed agents and toxins; and
(II) when requested by the person involved, of a determination under paragraph (6) to deny or revoke registration for such person.
(ii) Ex parte review
During a review under clause (i), the Secretary may consider information relevant to the review ex parte to the extent that disclosure of the information could compromise national security or an investigation by any law enforcement agency.
(iii) Final agency action
The decision of the Secretary in a review under clause (i) constitutes final agency action for purposes of section 702 of title 5.
(B) Certain procedures
(i) Submission of ex parte materials in judicial proceedings
When reviewing a decision of the Secretary under subparagraph (A), and upon request made ex parte and in writing by the United States, a court, upon a sufficient showing, may review and consider ex parte documents containing information the disclosure of which could compromise national security or an investigation by any law enforcement agency. If the court determines that portions of the documents considered ex parte should be disclosed to the person involved to allow a response, the court shall authorize the United States to delete from such documents specified items of information the disclosure of which could compromise national security or an investigation by any law enforcement agency, or to substitute a summary of the information to which the person may respond. Any order by the court authorizing the disclosure of information that the United States believes could compromise national security or an investigation by any law enforcement agency shall be subject to the processes set forth in subparagraphs (A) and (B)(i) of section 2339B(f)(5) of title 18 (relating to interlocutory appeal and expedited consideration).
(ii) Disclosure of information
In a review under subparagraph (A), and in any judical 1 proceeding conducted pursuant to such review, neither the Secretary nor the Attorney General may be required to disclose to the public any information that under subsection (h) shall not be disclosed under section 552 of title 5.
(8) Notifications regarding theft or loss of agents
Requirements under paragraph (1) shall include the prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the theft or loss of listed agents and toxins.
(9) Technical assistance for registered persons
The Secretary, in consultation with the Attorney General, may provide technical assistance to registered persons to improve security of the facilities of such persons.
(f) Inspections
The Secretary shall have the authority to inspect persons subject to regulations under subsection (b) or (c) to ensure their compliance with such regulations, including prohibitions on restricted persons and other provisions of subsection (e).
(g) Exemptions
(1) Clinical or diagnostic laboratories
Regulations under subsections (b) and (c) shall exempt clinical or diagnostic laboratories and other persons who possess, use, or transfer listed agents or toxins that are contained in specimens presented for diagnosis, verification, or proficiency testing, provided that—
(A) the identification of such agents or toxins is reported to the Secretary, and when required under Federal, State, or local law, to other appropriate authorities; and
(B) such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation.
(2) Products
(A) In general
Regulations under subsections (b) and (c) shall exempt products that are, bear, or contain listed agents or toxins and are cleared, approved, licensed, or registered under any of the Acts specified in subparagraph (B), unless the Secretary by order determines that applying additional regulation under subsection (b) or (c) to a specific product is necessary to protect public health and safety.
(B) Relevant laws
For purposes of subparagraph (A), the Acts specified in this subparagraph are the following:
(i) The Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
(ii) Section 262 of this title.
(iii) The Act commonly known as the Virus-Serum-Toxin Act (the eighth paragraph under the heading “Bureau of Animal Industry” in the Act of March 4, 1913; 21 U.S.C. 151–159).
(iv) The Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.].
(C) Investigational use
(i) In general
The Secretary may exempt an investigational product that is, bears, or contains a listed agent or toxin from the applicability of provisions of regulations under subsection (b) or (c) 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) to such product is not necessary to protect public health and safety.
(ii) Certain processes
Regulations under subsections (b) and (c) shall set forth the procedures for applying for an exemption under clause (i). In the case of investigational products authorized under any of the Acts specified in subparagraph (B), the Secretary shall make a determination regarding a request for an exemption not later than 14 days after the first date on which both of the following conditions have been met by the person requesting the exemption:
(I) The person has submitted to the Secretary an application for the exemption meeting the requirements established by the Secretary.
(II) The person has notified the Secretary that the investigation has been authorized under such an Act.
(3) Public health emergencies
The Secretary may temporarily exempt a person from the applicability of the requirements of this section, in whole or in part, if the Secretary determines that such exemption is necessary to provide for the timely participation of the person in a response to a domestic or foreign public health emergency (whether determined under section 247d(a) of this title or otherwise) that involves a listed agent or toxin. With respect to the emergency involved, such exemption for a person may not exceed 30 days, except that the Secretary, after review of whether such exemption remains necessary, may provide one extension of an additional 30 days.
(4) Agricultural emergencies
Upon request of the Secretary of Agriculture, after the granting by such Secretary of an exemption under section 8401(g)(1)(D) of title 7 pursuant to a finding that there is an agricultural emergency, the Secretary of Health and Human Services may temporarily exempt a person from the applicability of the requirements of this section, in whole or in part, to provide for the timely participation of the person in a response to the agricultural emergency. With respect to the emergency involved, the exemption under this paragraph for a person may not exceed 30 days, except that upon request of the Secretary of Agriculture, the Secretary of Health and Human Services may, after review of whether such exemption remains necessary, provide one extension of an additional 30 days.
(h) Disclosure of information
(1) Nondisclosure of certain information
No Federal agency specified in paragraph (2) shall disclose under section 552 of title 5 any of the following:
(A) Any registration or transfer documentation submitted under subsections (b) and (c) for the possession, use, or transfer of a listed agent or toxin; or information derived therefrom to the extent that it identifies the listed agent or toxin possessed, used, or transferred by a specific registered person or discloses the identity or location of a specific registered person.
(B) The national database developed pursuant to subsection (d), 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 public health or safety.
(2) Covered agencies
For purposes of paragraph (1) only, the Federal agencies specified in this paragraph are the following:
(A) The Department of Health and Human Services, the Department of Justice, the Department of Agriculture, and the Department of Transportation.
(B) Any Federal agency to which information specified in paragraph (1) is transferred by any agency specified in subparagraph (A) of this paragraph.
(C) Any Federal agency that is a registered person, or has a sub-agency component that is a registered person.
(D) Any Federal agency that awards grants or enters into contracts or cooperative agreements involving listed agents and toxins to or with a registered person, and to which information specified in paragraph (1) is transferred by any such registered person.
(3) Other exemptions
This subsection may not be construed as altering the application of any exemptions to public disclosure under section 552 of title 5, except as to subsection 2 552(b)(3) of such title, to any of the information specified in paragraph (1).
(4) Rule of construction
Except as specifically provided in paragraph (1), this subsection may not be construed as altering the authority of any Federal agency to withhold under section 552 of title 5, or the obligation of any Federal agency to disclose under section 552 of title 5, any information, including information relating to—
(A) listed agents and toxins, or individuals seeking access to such agents and toxins;
(B) registered persons, or persons seeking to register their possession, use, or transfer of such agents and toxins;
(C) general safeguard and security policies and requirements under regulations under subsections (b) and (c); 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) shall be subject to the United States for a civil money penalty in an amount not exceeding $250,000 in the case of an individual and $500,000 in the case of any other person.
(2) Applicability of certain provisions
The provisions of section 1320a–7a of this title (other than subsections (a), (b), (h), and (i), the first sentence of subsection (c), and paragraphs (1) and (2) of subsection (f)) shall apply to a civil money penalty under paragraph (1) in the same manner as such provisions apply to a penalty or proceeding under section 1320a–7a(a) of this title. The Secretary may delegate authority under this subsection in the same manner as provided in section 1320a–7a(j)(2) of this title, and such authority shall include all powers as contained in section 406 of title 5.
(j) Notification in event of release
Regulations under subsections (b) and (c) shall require the prompt notification of the Secretary by a registered person whenever a release, meeting criteria established by the Secretary, of a listed agent or toxin has occurred outside of the biocontainment area of a facility of the registered person. Upon receipt of such notification and a finding by the Secretary that the release poses a threat to public health or safety, the Secretary shall take appropriate action to notify relevant State and local public health authorities, other relevant Federal authorities, and, if necessary, other appropriate persons (including the public). If the released listed agent or toxin is an overlap agent or toxin (as defined in subsection (l)), the Secretary shall promptly notify the Secretary of Agriculture upon notification by the registered person.
(k) Reports
(1) Notification with respect to Federal facilities
In the event of the release, loss, or theft of an agent or toxin listed by the Secretary pursuant to subsection (a)(1), or by the Secretary of Agriculture pursuant to section 8401(a)(1) of title 7, from or within a laboratory facility owned or operated by the Department of Health and Human Services, or other Federal laboratory facility subject to the requirements of this section, the Secretary, in a manner that does not compromise national security, shall—
(A) not later than 72 hours after such event is reported to the Secretary, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives of such event, including—
(i) the Federal laboratory facility in which such release, loss, or theft occurred; and
(ii) the circumstances of such release, loss, or theft; and
(B) not later than 14 days after such notification, update such Committees on—
(i) any actions taken or planned by the Secretary to mitigate any potential threat such release, loss, or theft may pose to public health and safety; and
(ii) any actions taken or planned by the Secretary to review the circumstances of such release, loss, or theft, and prevent similar events.
(2) Annual report
The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on an annual basis a report—
(A) summarizing the number and nature of notifications received under subsection (e)(8) (relating to theft or loss) and subsection (j) (relating to releases), during the preceding fiscal year;
(B) describing actions taken by the Secretary to address such incidents, such as any corrective action plans required and steps taken to promote adherence to, and compliance with, safety and security best practices, standards, and regulations; and
(C) describing any gaps, challenges, or limitations with respect to ensuring that such safety and security practices are consistently applied and adhered to, and actions taken to address such gaps, challenges, or limitations.
(3) Implementation of recommendations of the Federal Experts Security Advisory Panel and the fast track action committee on select agent regulations
(A) In general
Not later than 1 year after June 24, 2019, the Secretary shall report to the congressional committees of jurisdiction on the implementation of recommendations of the Federal Experts Security Advisory Panel concerning the select agent program.
(B) Continued updates
The Secretary shall report to the congressional committees of jurisdiction annually following the submission of the report under subparagraph (A) until the recommendations described in such subparagraph are fully implemented, or a justification is provided for the delay in, or lack of, implementation.
(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).
(3) The term “listed agents or toxins” means biological agents or toxins listed pursuant to subsection (a)(1).
(4) The term “overlap agents and toxins” means biological agents and toxins that—
(A) are listed pursuant to subsection (a)(1); and
(B) are listed pursuant to section 8401(a)(1) of title 7.
(5) The term “overlap agent or toxin” means a biological agent or toxin that—
(A) is listed pursuant to subsection (a)(1); and
(B) is listed pursuant to section 8401(a)(1) of title 7.
(6) The term “person” includes Federal, State, and local governmental entities.
(7) The term “registered person” means a person registered under regulations under subsection (b) or (c).
(8) The term “restricted person” has the meaning given such term in section 175b of title 18.
(m) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2023 through 2027.
(July 1, 1944, ch. 373, title III, § 351A, as added Pub. L. 107–188, title II, § 201(a), June 12, 2002, 116 Stat. 637; amended Pub. L. 107–296, title XVII, § 1709(a), Nov. 25, 2002, 116 Stat. 2318; Pub. L. 116–22, title IV, § 405, June 24, 2019, 133 Stat. 949; Pub. L. 117–286, § 4(b)(75), Dec. 27, 2022, 136 Stat. 4351; Pub. L. 117–328, div. FF, title II, § 2311, Dec. 29, 2022, 136 Stat. 5759.)
heading: Editorial Notes
heading: References in Text
text: The Federal Food, Drug, and Cosmetic Act, referred to in subsec.(g)(2)(B)(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)(2)(B)(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)(2)(B)(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 Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.
heading: Amendments
text: 2022—Subsec. (b)(1)(A). Pub. L. 117–328, § 2311(1), amended subpar. (A) generally. Prior to amendment, text read as follows: “proper training and appropriate skills to handle such agents and toxins; and”.
Subsec. (e)(1). Pub. L. 117–328, § 2311(2), substituted “(including risks posed by the release, theft, or loss of such agent or toxin, or use in domestic or international terrorism)” for “(including the risk of use in domestic or international terrorism)”.
Subsec. (i)(2). Pub. L. 117–286 substituted “section 406 of title 5.” for “section 6 of the Inspector General Act of 1978 (5 U.S.C. App.).”
Subsec. (k)(1). Pub. L. 117–328, § 2311(3)(B), added par. (1). Former par. (1) redesignated (2).
Subsec. (k)(2). Pub. L. 117–328, § 2311(3)(A), (C), redesignated par. (1) as (2) and amended it generally. Prior to amendment, text read as follows: “The Secretary shall report to the Congress annually on the number and nature of notifications received under subsection (e)(8) (relating to theft or loss) and subsection (j) (relating to releases).” Former par. (2) redesignated (3).
Subsec. (k)(3). Pub. L. 117–328, § 2311(3)(A), redesignated par. (2) as (3).
Subsec. (m). Pub. L. 117–328, § 2311(4), substituted “fiscal years 2023 through 2027” for “fiscal years 2002 through 2007”.
2019—Subsec. (k). Pub. L. 116–22 designated existing provisions as par. (1), inserted heading, and added par. (2).
2002—Subsec. (e)(1). Pub. L. 107–296 substituted “collaboration with the Secretary of Homeland Security and” for “consultation with”.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of 2002 Amendment
text: 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.
heading: Effective Date
text: Pub. L. 107–188, title II, § 203(b), June 12, 2002, 116 Stat. 647, provided that: “Subsection (h) of section 351A of the Public Health Service Act [42 U.S.C. 262a(h)], as added by section 201 of this Act, is deemed to have taken effect on the effective date of the Antiterrorism and Effective Death Penalty Act of 1996 [Pub. L. 104–132, Apr. 24, 1996, 110 Stat. 1214].”
heading: Regulations
text: Pub. L. 107–188, title II, § 203(a), June 12, 2002, 116 Stat. 647, provided that: “Regulations promulgated by the Secretary of Health and Human Services under section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 [Pub. L. 104–132, 42 U.S.C. 262 note] are deemed to have been promulgated under section 351A of the Public Health Service Act [42 U.S.C. 262a], as added by section 201 of this Act. Such regulations, including the list under [former] subsection (d)(1) of such section 511, that were in effect on the day before the date of the enactment of this Act [June 12, 2002] remain in effect until modified by the Secretary in accordance with such section 351A and with section 202 of this Act [set out as a note below].”
heading: Improving Research and Development of Medical Countermeasures for Novel Pathogens
text: Pub. L. 117–328, div. FF, title II, § 2303(a), Dec. 29, 2022, 136 Stat. 5758, provided that:
“(1) Sample access.—
Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall make publicly available policies and procedures related to public and private entities accessing specimens of, or specimens containing, pathogens or suitable surrogates for, or alternatives to, such pathogens as the Secretary determines appropriate to support public health preparedness and response activities or biomedical research for purposes of the development and validation, as applicable, of medical products to address emerging infectious diseases and for use to otherwise respond to emerging infectious diseases. Such policies and procedures shall take into account, as appropriate, any applicable existing Federal resources.
“(2) Guidance.—
The Secretary shall issue guidance regarding the procedures for carrying out paragraph (1), including—
“(A) the method for requesting such samples;
“(B) considerations for sample availability and use of suitable surrogates or alternatives to such pathogens, as appropriate, including applicable safeguard and security measures; and
“(C) information required to be provided in order to receive such samples or suitable surrogates or alternatives.”
heading: Strategy for Federal High-Containment Laboratories
text: Pub. L. 117–328, div. FF, title II, § 2312, Dec. 29, 2022, 136 Stat. 5761, provided that:
“(a) Strategy for Federal High-containment Laboratories.—
Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Director of the Office of Science and Technology Policy, in consultation with relevant Federal departments and agencies, shall establish a strategy for the management, maintenance, and oversight of federally-owned laboratory facilities operating at Biosafety Level 3 or 4, including equivalent classification levels and facilities with Biosafety Level 4 capabilities. Such strategy shall include—
“(1) a description of the roles and responsibilities of relevant Federal departments and agencies with respect to the management, maintenance, and oversight of Biosafety Level 3 or 4 laboratory facilities;
“(2) an assessment of the needs of the Federal Government with respect to Biosafety Level 3 or 4 laboratory facilities;
“(3) a summary of existing federally-owned Biosafety Level 3 or 4 laboratory facility capacity;
“(4) a summary of other Biosafety Level 3 or 4 laboratory facility capacity established through Federal funds;
“(5) a description of how the capacity described in paragraphs (3) and (4) addresses the needs of the Federal Government, including—
“(A) how relevant Federal departments and agencies coordinate to provide access to appropriate laboratory facilities to reduce unnecessary duplication; and
“(B) any gaps in such capacity related to such needs;
“(6) a summary of plans that are in place for the maintenance of such capacity within each relevant Federal department or agency, as applicable and appropriate, including processes for determining whether to maintain or expand such capacity, and a description of how the Federal Government will address rapid changes in the need for such capacity within each relevant Federal department or agency during a public health emergency; and
“(7) a description of how the heads of relevant Federal departments and agencies will coordinate to ensure appropriate oversight of federally-owned laboratory facility capacity and leverage such capacity within each relevant Federal department, as appropriate, to fulfill the needs of each Federal department and agency in order to reduce unnecessary duplication and improve collaboration within the Federal Government.
“(b) Clarification.—
The strategy under subsection (a) shall not be construed to supersede the authorities of each relevant Federal department or agency with respect to the management, maintenance, and oversight of the Federally-owned laboratory facilities operated by any such Federal department or agency.”
heading: Research To Improve Biosafety
text: Pub. L. 117–328, div. FF, title II, § 2314, Dec. 29, 2022, 136 Stat. 5763, provided that:
“(a) In General.—
The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall, as appropriate, conduct or support research to improve the safe conduct of biomedical research activities involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)).
“(b) Report.—
Not later than 5 years after the date of enactment of this Act [Dec. 29, 2022], the Secretary shall prepare and submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding an overview of any research conducted or supported under this section, any relevant findings, and steps the Secretary is taking to disseminate any such findings to support the reduction of risks associated with biomedical research involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)).”
heading: National Science Advisory Board for Biosecurity
text: Pub. L. 109–417, title II, § 205, Dec. 19, 2006, 120 Stat. 2851, formerly set out as a note under this section, was transferred and is set out as a note under section 283r of this title.
heading: Report to Congress
text: Pub. L. 107–188, title II, § 201(b), June 12, 2002, 116 Stat. 646, required the Secretary of Health and Human Services to report to Congress not later than one year after June 12, 2002, on the implementation, compliance, and future plans under this section.
heading: Implementation by Department of Health and Human Services
text: Pub. L. 107–188, title II, § 202, June 12, 2002, 116 Stat. 646, provided that:
“(a) Date Certain for Notice of Possession.—
Not later than 90 days after the date of the enactment of this Act [June 12, 2002], all persons (unless exempt under subsection (g) of section 351A of the Public Health Service Act [42 U.S.C. 262a(g)], as added by section 201 of this Act) in possession of biological agents or toxins listed under such section 351A of the Public Health Service Act [42 U.S.C. 262a] shall notify the Secretary of Health and Human Services of such possession. Not later than 30 days after such date of enactment, the Secretary shall provide written guidance on how such notice is to be provided to the Secretary.
“(b) 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 of Health and Human Services shall promulgate an interim final rule for carrying out section 351A of the Public Health Service Act [42 U.S.C. 262a], subject to subsection (c). 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 351A(i) of the Public Health Service Act [42 U.S.C. 262a(i)] (relating to civil penalties).
“(c) Transitional Provision Regarding Current Research and Education.—
The interim final rule under subsection (b) 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 351A(a)(1) of the Public Health Service Act [42 U.S.C. 262a(a)(1)] and that were underway as of the effective date of such rule.”
heading: Executive Documents
heading: Ex. Ord. No. 13546. Optimizing the Security of Biological Select Agents and Toxins in the United States
text: Ex. Ord. No. 13546, July 2, 2010, 75 F.R. 39439, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Section 1. Policy. It is the policy of the United States that:
(a) A robust and productive scientific enterprise that utilizes biological select agents and toxins (BSAT) is essential to national security;
(b) BSAT shall be secured in a manner appropriate to their risk of misuse, theft, loss, and accidental release; and
(c) Security measures shall be taken in a coordinated manner that balances their efficacy with the need to minimize the adverse impact on the legitimate use of BSAT.
Sec. 2. Definitions. (a) “Select Agent Program” (SAP) means the regulatory oversight and administrative activities conducted by the Secretaries of Health and Human Services and Agriculture and the Attorney General to implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Agricultural Bioterrorism Protection Act of 2002.
(b) “Select Agent Regulations” (SAR) means the Federal regulations found in Part 73 of Title 42 of the Code of Federal Regulations, Part 331 of Title 7 of the Code of Federal Regulations, and Part 121 of Title 9 of the Code of Federal Regulations.
(c) “Biological Select Agents and Toxins” means biological agents and toxins with the potential to pose a severe threat to public health and safety, animal and plant health, or animal and plant products and whose possession, use, and transfer are regulated by the Department of Health and Human Services and the Department of Agriculture under the SAR.
Sec. 3. Findings. (a) The use of BSAT presents the risk that BSAT might be lost, stolen, or diverted for malicious purpose. The SAP exists to provide effective regulatory oversight of the possession, use, and transfer of BSAT that reduces the risk of their misuse or mishandling. The absence of clearly defined, risk-based security measures in the SAR/SAP has raised concern about the need for optimized security and for risk management.
(b) In addition, variations in, and limited coordination of, individual executive departments’ and agencies’ oversight, security practices, and inspections have raised concerns that the cost and complexity of compliance for those who are registered to work with BSAT could discourage research or other legitimate activities.
(c) Understanding that research and laboratory work on BSAT is essential to both public health and national security, it is in the interest of the United States to address these issues.
Sec. 4. Risk-based Tiering of the Select Agent List. To help ensure that BSAT are secured according to level of risk, the Secretaries of Health and Human Services and Agriculture shall, through their ongoing review of the biological Select Agents and Toxins List (“Select Agent List”) contained in regulations, and no later than 18 months from the date of this order:
(a) designate a subset of the Select Agent List (Tier 1) that presents the greatest risk of deliberate misuse with most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence;
(b) explore options for graded protection of Tier 1 agents and toxins as described in subsection (a) of this section to permit tailored risk management practices based upon relevant contextual factors; and
(c) consider reducing the overall number of agents and toxins on the Select Agent List.
Sec. 5. Revision of Regulations, Rules, and Guidance to Accommodate a Tiered Select Agent List. Consistent with section 4 of this order, I request that:
(a) The Secretaries of Health and Human Services and Agriculture, no later than 15 months from the date of this order, propose amendments to their respective parts of the SAR that would establish security standards specific to Tier 1 agents and toxins.
(b) The Secretaries of Health and Human Services and Agriculture each, no later than 27 months from the date of this order, promulgate final rules and guidance that clearly articulate security actions for registrants who possess, use, or transfer Tier 1 agents and toxins.
Sec. 6. Coordination of Federal Oversight for BSAT Security. To ensure that the policies and practices used to secure BSAT are harmonized and that the related oversight activities of the Federal Government are coordinated, the heads of executive departments and agencies identified in section 7(a)(ii) of this order shall:
(a) no later than 6 months from the date of this order, develop and implement a plan for the coordination of BSAT security oversight that:
(i) articulates a mechanism for coordinated and reciprocal inspection of and harmonized administrative practices for facilities registered with the SAP;
(ii) ensures consistent and timely identification and resolution of BSAT security and compliance issues;
(iii) facilitates information sharing among departments and agencies regarding ongoing oversight and inspection activities; and
(iv) provides for comprehensive and effective Federal oversight of BSAT security; and
(b) no later than 6 months from the issuance of final rules and guidance as described in section 5 of this order, and annually thereafter, review for inconsistent requirements and revise or rescind, as appropriate, any regulations, directives, guidance, or policies regarding BSAT security within their department or agency that exceed those in the updated SAR and guidance as described in section 5 of this order.
Sec. 7. Implementation. (a) Establishment, Operation, and Functions of the Federal Experts Security Advisory Panel.
(i) There is hereby established, within the Department of Health and Human Services for administrative purposes only, the Federal Experts Security Advisory Panel (Panel), which shall make technical and substantive recommendations on BSAT security concerning the SAP.
(ii) The Panel shall consist of representatives from the following, who may consult with additional experts from their department or agency as required:
1. the Department of State;
2. the Department of Defense;
3. the Department of Justice;
4. the Department of Agriculture (Co-Chair);
5. the Department of Commerce;
6. the Department of Health and Human Services (Co-Chair);
7. the Department of Transportation;
8. the Department of Labor;
9. the Department of Energy;
10. the Department of Veterans Affairs;
11. the Department of Homeland Security;
12. the Environmental Protection Agency;
13. the Office of the Director of National Intelligence;
14. the Office of Science and Technology Policy;
15. the Joint Chiefs of Staff; and
16. any other department or agency designated by the Co-Chairs.
(iii) To assist the Secretaries of Health and Human Services and Agriculture and the Attorney General in implementing the policies set forth in sections 1, 4, 5, and 6 of this order, the Panel shall, no later than 4 months from the date of this order, provide consensus recommendations concerning the SAP on:
1. the designation of Tier 1 agents and toxins;
2. reduction in the number of agents on the Select Agent List;
3. the establishment of appropriate practices to ensure reliability of personnel with access to Tier 1 agents and toxins at registered facilities;
4. the establishment of appropriate practices for physical security and cyber security for facilities that possess Tier 1 agents. The Department of Homeland Security shall Chair a Working Group of the Panel that develops recommended laboratory critical infrastructure security standards in these areas; and
5. other emerging policy issues relevant to the security of BSAT.
Thereafter, the Panel shall continue to provide technical advice concerning the SAP on request.
(iv) If the Panel is unable to reach consensus on recommendations for an issue within its charge, the matter shall be resolved through the interagency policy committee process led by the National Security Staff.
(v) The Secretaries of Health and Human Services and Agriculture and the Attorney General shall report to the Assistant to the President for Homeland Security and Counterterrorism on the consideration and implementation of Panel recommendations concerning the SAP, including a rationale for failure to implement any recommendations.
(vi) The Panel shall be chartered for a period of 4 years subject to renewal through the interagency policy committee process led by the National Security Staff.
(b) To further assist the Secretaries of Health and Human Services and Agriculture and the Attorney General in implementing the policy set forth in sections 1, 4, 5, and 6 of this order, the National Science Advisory Board for Biosecurity shall provide technical advice and serve as a conduit for public consultation, as needed, on topics of relevance to the SAP.
Sec. 8. Sharing of Select Agent Program Information. (a) Consistent with applicable laws and regulations, the Secretaries of Health and Human Services and Agriculture and the Attorney General shall, no later than 6 months from the date of this order, develop a process and the criteria for making SAP information available to executive departments and agencies when such information is necessary for furthering a public health, safety, security, law enforcement, or national security mission.
(b) SAP information shall continue to be safeguarded properly and handled securely to minimize the risk of disclosing sensitive, personal, and other information protected by the Privacy Act, 5 U.S.C. 552a.
Sec. 9. General Provisions. (a) The National Security Staff shall, on a biennial basis, review the implementation and effectiveness of this order and refer to the interagency policy committee process any issues that require further deliberation or adjudication.
(b) Nothing in this order shall be construed to impair or otherwise affect the authority granted by law to a department or agency, or the head thereof, or functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(c) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(d) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Barack Obama.
[Reference to the National Security Staff deemed to be a reference to the National Security Council Staff, see Ex. Ord. No. 13657, set out as a note under section 3021 of Title 50, War and National Defense.]