Requiring certain distributors of highly pathogenic agents to keep a logbook of sales, leases, loans, and other transfers

(a) Program The Secretary of Health and Human Services, acting through the Administration for Strategic Preparedness and Response, shall carry out a program under which the Secretary requires each covered distributor of a highly pathogenic agent to comply with the logbook requirements of subsection (c). (b) List of highly pathogenic agents (1) Development The Secretary shall develop and maintain a list of all agents that meet the definition of a highly pathogenic agent in subsection (e). (2) Initial list The Secretary shall develop the initial list required by paragraph (1) not later than 6 months after the date of enactment of this Act. (3) Periodic review The Secretary shall annually review and update the list required by paragraph (1). (4) Consultation; consideration In developing and updating the list required by paragraph (1), the Secretary shall— (A) consult with relevant agencies, including the Centers for Disease Control and Prevention, the National Institutes of Health, the Department of Homeland Security, the Department of Agriculture, the Department of the Interior, and the Department of Defense; (B) take into consideration the latest edition of Biosafety in Microbiological and Biomedical Laboratories published by the Centers for Disease Control and Prevention and the National Institutes of Health (or any successor to such publication); and (C) take into consideration the latest edition of NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules published by the National Institutes of Health (or any successor to such publication). (c) Logbook requirements (1) In general Each covered distributor shall maintain, in accordance with such criteria and format as the Secretary may require, an electronic list (in this section referred to as a logbook) of the sales, leases, loans, or other transfers by such distributor of each highly pathogenic agent on the list under subsection (b). (2) Contents The covered distributor shall, for each sale, lease, loan, or other transfer referred to in paragraph (1), include in the logbook— (A) the agent by name; (B) the name, address, telephone number, and email address of the purchaser; (C) other relevant identifying business information of the purchaser, as deemed necessary by the Secretary; (D) a short description of— (i) the purchaser’s intended use of the highly pathogenic agent; and (ii) where the purchaser will house the agent; (E) the date and time of the sale, lease, loan, or other transfer; (F) the method, date, and time of transfer of the highly pathogenic agent; (G) a physical or electronic signature of the purchaser; and (H) such other data elements as the Secretary may require. (3) Sale requirements In the case of a sale, lease, loan, or other transfer to which paragraph (1) applies, the covered distributor shall not sell the highly pathogenic agent unless— (A) the prospective purchaser, in physical form or electronically in compliance with the Electronic Signatures in Global and National Commerce Act (42 U.S.C. 7001 et seq.)— (i) presents an identification card that provides a photograph and is issued by a State or the Federal Government, or a document that, with respect to identification, is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of title 8, Code of Federal Regulations (or successor regulations); and (ii) verifies by signature in the logbook— (I) the purchaser’s name and address; (II) a short description of— (aa) the purchaser’s intended use of the agent; and (bb) where the purchaser will house the agent; (III) the date and time of the sale, lease, loan, or other transfer; and (IV) the method, date, and time of transfer of the agent; and (B) the covered distributor— (i) determines that the name entered in the logbook corresponds to the name provided on the identification card referred to in subparagraph (A)(i), and that the information entered pursuant to subparagraph (A)(ii) is correct; and (ii) enters in the logbook the name of the highly pathogenic agent. (4) Contents The covered distributor shall include in the logbook, in accordance with criteria of the Secretary, a notice to purchasers that entering false statements or misrepresentations in the logbook may subject the purchasers to criminal penalties under section 1001 of title 18, United States Code, which notice specifies the maximum fine and term of imprisonment under such section. (5) Duration of maintenance of entries (A) Retention period The covered distributor shall maintain each entry in the logbook for not fewer than three years after the date on which the entry is made. (B) Successor entity If ownership of a covered distributor changes, the successor entity shall assume custody of and responsibility for all logbooks for the balance of the three-year retention period required by subparagraph (A). (6) Disclosure of logbooks The Secretary shall establish restrictions on disclosure of information in logbooks. Such regulations shall— (A) provide for the disclosure of the information as appropriate to the Secretary, Federal, State, local, Tribal, and territorial law enforcement agencies, and State health officials; and (B) prohibit accessing, using, or sharing information in the logbooks for any purpose other than— (i) to ensure compliance with this section; (ii) to protect public health and safety; or (iii) to protect national security. (7) FOIA exemption Logbooks and any derivative data are exempt from disclosure under section 552(b)(3) of title 5, United States Code. (d) False statements or misrepresentations by purchasers For purposes of section 1001 of title 18, United States Code, entering information in a logbook shall be considered a matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States. (e) Definitions In this section: (1) The term highly pathogenic agent — (A) subject to subparagraph (B), means a pathogenic agent that meets the criteria of risk group 3 or any higher level risk groups as such risk groups are defined in the latest edition of NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules published by the National Institutes of Health (or any successor to such publication); and (B) excludes any biological agent or toxin that is regulated under section 351A of the Public Health Service Act (42 U.S.C. 262a) or section 212 of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401). (2) The term covered distributor — (A) means an entity that sells, leases, loans, or otherwise transfers for value or without value a highly pathogenic agent, except that such term does not include an employee or agent of such a distributor; and (B) includes a publicly funded repository or biobank that sells, leases, loans, or otherwise transfers a highly pathogenic agent, as described in subparagraph (A). (3) The term Secretary means the Secretary of Health and Human Services, acting through the Administration for Strategic Preparedness and Response. (f) Rule of construction Nothing in this section shall be construed to supersede or otherwise affect the Federal Select Agent Program under section 351A of the Public Health Service Act (42 U.S.C. 262a) and section 212 of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401).