42 U.S.C. § 262a — Enhanced control of dangerous biological

Page 468 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 262a ployees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, set out as a note under section 202 of this title. References to Secretary and Department of Health, Education, and Welfare substituted for references to Federal Security Administrator and Federal Security Agency, respectively, pursuant to Reorg. Plan No. 1 of 1953, § 5, set out as a note under section 3501 of this title, which transferred all functions of Federal Secu- rity Administrator to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agen- cy to Department of Health, Education, and Welfare. Federal Security Agency and office of Administrator abolished by section 8 of Reorg. Plan No. 1 of 1953. § 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 estab- lish 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 subpara- graph (A), the Secretary shall— (i) consider— (I) the effect on human health of expo- sure 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 hu- mans; (III) the availability and effectiveness of pharmacotherapies and immuniza- tions to treat and prevent any illness re- sulting from infection by the agent or toxin; and (IV) any other criteria, including the needs of children and other vulnerable populations, that the Secretary con- siders appropriate; and (ii) consult with appropriate Federal de- partments and agencies and with scientific experts representing appropriate profes- sional groups, including groups with pedi- atric 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 en- sure— (A) proper training, including with respect to notification requirements under this sec- tion, of— (i) individuals who are involved in the handling and use of such agents and tox- ins, 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, pos- sessed, or used; and (iii) individuals who perform administra- tive or oversight functions of the facility related to the transfer, possession, or use of such agents and toxins on behalf of reg- istered 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 do- mestic or international terrorism or for any other criminal purpose; (3) the establishment of procedures to pro- tect the public safety in the event of a trans- fer or potential transfer of such an agent or toxin in violation of the safety procedures es- tablished under paragraph (1) or the safeguard and security measures established under para- graph (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 provi- sions 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) informa- tion regarding the characterization of listed agents and toxins to facilitate their identifica- tion, including their source. The Secretary shall maintain a national database that in- cludes the names and locations of registered persons, the listed agents and toxins such per- sons are possessing, using, or transferring, and information regarding the characterization of such agents and toxins. (e) Safeguard and security requirements for reg- istered persons (1) In general Regulations under subsections (b) and (c) shall include appropriate safeguard and secu- Page 469 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 262a rity 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 (in- cluding 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 collabora- tion 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 regula- tions. (2) Limiting access to listed agents and toxins Requirements under paragraph (1) shall in- clude provisions to ensure that registered per- sons— (A) provide access to listed agents and tox- ins to only those individuals whom the reg- istered person involved determines have a le- gitimate need to handle or use such agents and toxins; (B) submit the names and other identi- fying information for such individuals to the Secretary and the Attorney General, promptly after first determining that the in- dividuals need access under subparagraph (A), and periodically thereafter while the in- dividuals have such access, not less fre- quently 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 cat- egory under paragraph (3)(B)(ii), if limiting or denying such access by the individuals in- volved is determined appropriate by the Sec- retary, in consultation with the Attorney General. (3) Submitted names; use of databases by attor- ney general (A) In general Upon the receipt of names and other iden- tifying information under paragraph (2)(B), the Attorney General shall, for the sole pur- pose 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 cat- egories specified in this subparagraph re- garding an individual are that— (i) the individual is a restricted person; or (ii) the individual is reasonably sus- pected by any Federal law enforcement or intelligence agency of— (I) committing a crime set forth in sec- tion 2332b(g)(5) of title 18; (II) knowing involvement with an or- ganization that engages in domestic or international terrorism (as defined in section 2331 of such title 18) or with any other organization that engages in inten- tional 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 regard- ing submitted names After the receipt of a name and other iden- tifying information under paragraph (2)(B), the Attorney General shall promptly notify the Secretary whether the individual is within any of the categories specified in sub- paragraph (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 identi- fying information under paragraph (2)(B) and who demonstrates good cause, the Secretary may, as determined appropriate by the Sec- retary— (A) request the Attorney General to expe- dite the process of identification under para- graph (3)(A) and notification of the Sec- retary under paragraph (3)(C); and (B) expedite the notification of the reg- istered person by the Secretary under para- graph (4). (6) Process regarding persons seeking to reg- ister (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 pur- poses 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 At- torney General, who shall use criminal, im- migration, national security, and other elec- tronic databases available to the Federal Government, as appropriate for the purpose of promptly notifying the Secretary whether the person, or, where relevant, the indi- vidual who owns or controls such person, is a restricted person or is reasonably sus- pected by any Federal law enforcement or intelligence agency of being within any cat- egory specified in paragraph (3)(B)(ii) (as ap- plied to persons, including individuals). Such regulations shall provide that a person who Page 470 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 262a 1 So in original. Probably should be ‘‘judicial’’. seeks to register under either of such sub- sections is subject to the same processes de- scribed 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 re- quirements of this subparagraph. (7) Review (A) Administrative review (i) In general Regulations under subsections (b) and (c) shall provide for an opportunity for a re- view by the Secretary— (I) when requested by the individual involved, of a determination under para- graph (2) to deny the individual access to listed agents and toxins; and (II) when requested by the person in- volved, of a determination under para- graph (6) to deny or revoke registration for such person. (ii) Ex parte review During a review under clause (i), the Secretary may consider information rel- evant to the review ex parte to the extent that disclosure of the information could compromise national security or an inves- tigation 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 judi- cial proceedings When reviewing a decision of the Sec- retary under subparagraph (A), and upon request made ex parte and in writing by the United States, a court, upon a suffi- cient 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 enforce- ment agency, or to substitute a summary of the information to which the person may respond. Any order by the court au- thorizing the disclosure of information that the United States believes could com- promise national security or an investiga- tion by any law enforcement agency shall be subject to the processes set forth in sub- paragraphs (A) and (B)(i) of section 2339B(f)(5) of title 18 (relating to interlocu- tory appeal and expedited consideration). (ii) Disclosure of information In a review under subparagraph (A), and in any judical 1 proceeding conducted pur- suant to such review, neither the Sec- retary nor the Attorney General may be required to disclose to the public any in- formation 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 in- clude the prompt notification of the Sec- retary, 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 At- torney General, may provide technical assist- ance to registered persons to improve security of the facilities of such persons. (f) Inspections The Secretary shall have the authority to in- spect persons subject to regulations under sub- section (b) or (c) to ensure their compliance with such regulations, including prohibitions on restricted persons and other provisions of sub- section (e). (g) Exemptions (1) Clinical or diagnostic laboratories Regulations under subsections (b) and (c) shall exempt clinical or diagnostic labora- tories and other persons who possess, use, or transfer listed agents or toxins that are con- tained 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 Sec- retary by regulation. (2) Products (A) In general Regulations under subsections (b) and (c) shall exempt products that are, bear, or con- tain 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 safe- ty. (B) Relevant laws For purposes of subparagraph (A), the Acts specified in this subparagraph are the fol- lowing: (i) The Federal Food, Drug, and Cos- metic 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 para- Page 471 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 262a 2 So in original. Probably should be ‘‘section’’. graph under the heading ‘‘Bureau of Ani- mal 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 investiga- tional product that is, bears, or contains a listed agent or toxin from the applicability of provisions of regulations under sub- section (b) or (c) when such product is being used in an investigation authorized under any Federal Act and the Secretary determines that applying additional regu- lation 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 subpara- graph (B), the Secretary shall make a de- termination regarding a request for an ex- emption not later than 14 days after the first date on which both of the following conditions have been met by the person re- questing the exemption: (I) The person has submitted to the Secretary an application for the exemp- tion meeting the requirements estab- lished by the Secretary. (II) The person has notified the Sec- retary 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 require- ments of this section, in whole or in part, if the Secretary determines that such exemption is necessary to provide for the timely partici- pation of the person in a response to a domes- tic or foreign public health emergency (wheth- er determined under section 247d(a) of this title or otherwise) that involves a listed agent or toxin. With respect to the emergency in- volved, such exemption for a person may not exceed 30 days, except that the Secretary, after review of whether such exemption re- mains necessary, may provide one extension of an additional 30 days. (4) Agricultural emergencies Upon request of the Secretary of Agri- culture, 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 in- volved, the exemption under this paragraph for a person may not exceed 30 days, except that upon request of the Secretary of Agri- culture, the Secretary of Health and Human Services may, after review of whether such ex- emption remains necessary, provide one exten- sion 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 docu- mentation submitted under subsections (b) and (c) for the possession, use, or transfer of a listed agent or toxin; or information de- rived therefrom to the extent that it identi- fies the listed agent or toxin possessed, used, or transferred by a specific registered person or discloses the identity or location of a spe- cific registered person. (B) The national database developed pursu- ant to subsection (d), or any other compila- tion of the registration or transfer informa- tion submitted under subsections (b) and (c) to the extent that such compilation dis- closes site-specific registration or transfer information. (C) Any portion of a record that discloses the site-specific or transfer-specific safe- guard and security measures used by a reg- istered person to prevent unauthorized ac- cess 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 per- son conducted under subsection (f) that iden- tifies the listed agent or toxin possessed by a specific registered person or that discloses the identity or location of a specific reg- istered 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 Fed- eral agencies specified in this paragraph are the following: (A) The Department of Health and Human Services, the Department of Justice, the De- partment of Agriculture, and the Depart- ment of Transportation. (B) Any Federal agency to which informa- tion 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 tox- ins 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 al- tering 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, Page 472 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 262a to any of the information specified in para- graph (1). (4) Rule of construction Except as specifically provided in paragraph (1), this subsection may not be construed as al- tering the authority of any Federal agency to withhold under section 552 of title 5, or the ob- ligation 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, deni- als 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 Con- gress or any committee or subcommittee thereof; or (B) to withhold information from any per- son 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 ex- ceeding $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 para- graph (1) in the same manner as such provi- sions 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 sec- tion 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, meet- ing criteria established by the Secretary, of a listed agent or toxin has occurred outside of the biocontainment area of a facility of the reg- istered 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 no- tify relevant State and local public health au- thorities, other relevant Federal authorities, and, if necessary, other appropriate persons (in- cluding 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 notifi- cation by the registered person. (k) Reports (1) Notification with respect to Federal facili- ties In the event of the release, loss, or theft of an agent or toxin listed by the Secretary pur- suant 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 require- ments of this section, the Secretary, in a man- ner that does not compromise national secu- rity, 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 Com- mittee on Energy and Commerce of the House of Representatives of such event, in- cluding— (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 notifi- cation, 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 Com- mittee on Health, Education, Labor, and Pen- sions of the Senate and the Committee on En- ergy and Commerce of the House of Represent- atives 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 Sec- retary to address such incidents, such as any corrective action plans required and steps taken to promote adherence to, and compli- ance with, safety and security best prac- tices, standards, and regulations; and (C) describing any gaps, challenges, or lim- itations with respect to ensuring that such safety and security practices are consist- ently applied and adhered to, and actions taken to address such gaps, challenges, or limitations. Page 473 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 262a (3) Implementation of recommendations of the Federal Experts Security Advisory Panel and the fast track action committee on se- lect agent regulations (A) In general Not later than 1 year after June 24, 2019, the Secretary shall report to the congres- sional committees of jurisdiction on the im- plementation of recommendations of the Federal Experts Security Advisory Panel concerning the select agent program. (B) Continued updates The Secretary shall report to the congres- sional committees of jurisdiction annually following the submission of the report under subparagraph (A) until the recommendations described in such subparagraph are fully im- plemented, 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 pur- suant 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 sub- section (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.) Editorial Notes REFERENCES IN 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 Indus- try’’ 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 sec- tion 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. AMENDMENTS 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), redes- ignated 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) (relat- ing to releases).’’ Former par. (2) redesignated (3). Subsec. (k)(3). Pub. L. 117–328, § 2311(3)(A), redesig- nated par. (2) as (3). Subsec. (m). Pub. L. 117–328, § 2311(4), substituted ‘‘fis- cal 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 ‘‘col- laboration 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, Do- mestic Security. EFFECTIVE DATE 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].’’ REGULATIONS 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 Page 474 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 262a 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].’’ IMPROVING RESEARCH AND DEVELOPMENT OF MEDICAL COUNTERMEASURES FOR NOVEL PATHOGENS 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 Sec- retary 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 al- ternatives to, such pathogens as the Secretary deter- mines appropriate to support public health prepared- ness and response activities or biomedical research for purposes of the development and validation, as applica- ble, 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 exist- ing 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 patho- gens, 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 alter- natives.’’ STRATEGY FOR FEDERAL HIGH-CONTAINMENT LABORATORIES Pub. L. 117–328, div. FF, title II, § 2312, Dec. 29, 2022, 136 Stat. 5761, provided that: ‘‘(a) STRATEGY FOR FEDERAL HIGH-CONTAINMENT LAB- ORATORIES.—Not later than 1 year after the date of en- actment of this Act [Dec. 29, 2022], the Director of the Office of Science and Technology Policy, in consulta- tion with relevant Federal departments and agencies, shall establish a strategy for the management, mainte- nance, and oversight of federally-owned laboratory fa- cilities operating at Biosafety Level 3 or 4, including equivalent classification levels and facilities with Bio- safety Level 4 capabilities. Such strategy shall in- clude— ‘‘(1) a description of the roles and responsibilities of relevant Federal departments and agencies with re- spect to the management, maintenance, and over- sight of Biosafety Level 3 or 4 laboratory facilities; ‘‘(2) an assessment of the needs of the Federal Gov- ernment with respect to Biosafety Level 3 or 4 labora- tory facilities; ‘‘(3) a summary of existing federally-owned Bio- safety Level 3 or 4 laboratory facility capacity; ‘‘(4) a summary of other Biosafety Level 3 or 4 lab- oratory facility capacity established through Federal funds; ‘‘(5) a description of how the capacity described in paragraphs (3) and (4) addresses the needs of the Fed- eral Government, including— ‘‘(A) how relevant Federal departments and agen- cies coordinate to provide access to appropriate laboratory facilities to reduce unnecessary duplica- tion; 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 ap- propriate, including processes for determining wheth- er to maintain or expand such capacity, and a de- scription 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 Fed- eral departments and agencies will coordinate to en- sure appropriate oversight of federally-owned labora- tory facility capacity and leverage such capacity within each relevant Federal department, as appro- priate, to fulfill the needs of each Federal department and agency in order to reduce unnecessary duplica- tion 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 re- spect to the management, maintenance, and oversight of the Federally-owned laboratory facilities operated by any such Federal department or agency.’’ RESEARCH TO IMPROVE BIOSAFETY 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 ‘Sec- retary’) shall, as appropriate, conduct or support re- search to improve the safe conduct of biomedical re- search activities involving pathogens of pandemic po- tential 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 reduc- tion of risks associated with biomedical research in- volving 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)).’’ NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY 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 National Science Advi- sory Board for Biosecurity: Provision of Advice, Guid- ance, or Recommendations note under section 283r of this title. REPORT TO CONGRESS Pub. L. 107–188, title II, § 201(b), June 12, 2002, 116 Stat. 646, required the Secretary of Health and Human Serv- ices to report to Congress not later than one year after June 12, 2002, on the implementation, compliance, and future plans under this section. IMPLEMENTATION BY DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 sec- tion 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 Sec- retary of Health and Human Services of such posses- sion. Not later than 30 days after such date of enact- ment, the Secretary shall provide written guidance on how such notice is to be provided to the Secretary. Page 475 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 262a ‘‘(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 Serv- ice 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 re- search 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.’’ Executive Documents EX. ORD. NO. 13546. OPTIMIZING THE SECURITY OF BIO- LOGICAL SELECT AGENTS AND TOXINS IN THE UNITED STATES 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 ac- tivities conducted by the Secretaries of Health and Human Services and Agriculture and the Attorney Gen- eral to implement the Public Health Security and Bio- terrorism Preparedness and Response Act of 2002 and the Agricultural Bioterrorism Protection Act of 2002. (b) ‘‘Select Agent Regulations’’ (SAR) means the Fed- eral 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 bio- logical 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 De- partment of Health and Human Services and the De- partment 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 trans- fer 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 man- agement. (b) In addition, variations in, and limited coordina- tion of, individual executive departments’ and agen- cies’ oversight, security practices, and inspections have raised concerns that the cost and complexity of compli- ance for those who are registered to work with BSAT could discourage research or other legitimate activi- ties. (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 ad- dress 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 infrastruc- ture, 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 stand- ards 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 Se- curity. To ensure that the policies and practices used to secure BSAT are harmonized and that the related over- sight activities of the Federal Government are coordi- nated, 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 re- ciprocal 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 depart- ments and agencies regarding ongoing oversight and in- spection 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 de- scribed in section 5 of this order. SEC. 7. Implementation. (a) Establishment, Operation, and Functions of the Federal Experts Security Advi- sory Panel. (i) There is hereby established, within the Depart- ment of Health and Human Services for administrative purposes only, the Federal Experts Security Advisory Panel (Panel), which shall make technical and sub- stantive recommendations on BSAT security con- cerning 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); Page 476 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263 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 Intel- ligence; 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 en- sure 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 Home- land 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 secu- rity of BSAT. Thereafter, the Panel shall continue to provide tech- nical advice concerning the SAP on request. (iv) If the Panel is unable to reach consensus on rec- ommendations for an issue within its charge, the mat- ter 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 Secu- rity and Counterterrorism on the consideration and im- plementation 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 pol- icy committee process led by the National Security Staff. (b) To further assist the Secretaries of Health and Human Services and Agriculture and the Attorney Gen- eral 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 need- ed, 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 Agri- culture 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 infor- mation is necessary for furthering a public health, safe- ty, security, law enforcement, or national security mis- sion. (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 implementa- tion 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 appro- priations. (d) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able 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.] § 263. Preparation of biological products by Serv- ice (a) The Service may prepare for its own use any product described in section 262 of this title and any product necessary to carrying out any of the purposes of section 241 of this title. (b) The Service may prepare any product de- scribed in section 262 of this title for the use of other Federal departments or agencies, and pub- lic or private agencies and individuals engaged in work in the field of medicine when such prod- uct is not available from establishments li- censed under such section. (July 1, 1944, ch. 373, title III, § 352, 58 Stat. 703.) Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted for ‘‘Secretary of Health, Education, and Wel- fare’’ pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education. Executive Documents TRANSFER OF FUNCTIONS Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and em- ployees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, set out as a note under section 202 of this title. § 263–1. Education on biological products (a) Internet website (1) In general The Secretary may maintain and operate an internet website to provide educational mate- rials for health care providers, patients, and caregivers, regarding the meaning of the terms, and the standards for review and licens- ing of, biological products, including bio- similar biological products and interchange- able biosimilar biological products. (2) Content Educational materials provided under para- graph (1) may include— (A) explanations of key statutory and reg- ulatory terms, including ‘‘biosimilar’’ and ‘‘interchangeable’’, and clarification regard- ing the use of interchangeable biosimilar bi- ological products;