HR5747-119

2. Requiring certain distributors of highly pathogenic agents to keep a logbook of sales, leases, loans, and other transfers 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). The Secretary shall develop and maintain a list of all agents that meet the definition of a highly pathogenic agent in subsection (e). The Secretary shall develop the initial list required by paragraph (1) not later than 6 months after the date of enactment of this Act. The Secretary shall annually review and update the list required by paragraph (1). In developing and updating the list required by paragraph (1), the Secretary shall— 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; 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 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). 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). The covered distributor shall, for each sale, lease, loan, or other transfer referred to in paragraph (1), include in the logbook— the agent by name; the name, address, telephone number, and email address of the purchaser; other relevant identifying business information of the purchaser, as deemed necessary by the Secretary; a short description of— the purchaser’s intended use of the highly pathogenic agent; and where the purchaser will house the agent; the date and time of the sale, lease, loan, or other transfer; the method, date, and time of transfer of the highly pathogenic agent; a physical or electronic signature of the purchaser; and such other data elements as the Secretary may require. 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— 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.)— 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 verifies by signature in the logbook— the purchaser’s name and address; a short description of— the purchaser’s intended use of the agent; and where the purchaser will house the agent; the date and time of the sale, lease, loan, or other transfer; and the method, date, and time of transfer of the agent; and the covered distributor— 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 enters in the logbook the name of the highly pathogenic agent. 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. 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. 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). The Secretary shall establish restrictions on disclosure of information in logbooks. Such regulations shall— 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 prohibit accessing, using, or sharing information in the logbooks for any purpose other than— to ensure compliance with this section; to protect public health and safety; or to protect national security. Logbooks and any derivative data are exempt from disclosure under section 552(b)(3) of title 5, United States Code. 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. In this section: The term highly pathogenic agent— 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 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). The term covered distributor— 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 includes a publicly funded repository or biobank that sells, leases, loans, or otherwise transfers a highly pathogenic agent, as described in subparagraph (A). The term Secretary means the Secretary of Health and Human Services, acting through the Administration for Strategic Preparedness and Response. 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).

3. Evaluation of high-containment laboratories The National Security Advisor, in consultation with the Secretary of Health and Human Services, the Secretary of Agriculture, the Secretary of Defense, the Secretary of Homeland Security, the Secretary of the Interior, the Director of National Intelligence, and such other Federal officials as the National Security Advisor determines appropriate, shall identify a single Federal entity to oversee a periodic strategic evaluation of high-containment laboratories in the United States. Each strategic evaluation under subsection (a) shall include— an assessment of— the number, location, and mission of high-containment laboratories; the capacity of such existing laboratories to effectively meet national goals to counter threats to biosafety and biosecurity; the physical security measures at high-containment laboratories; the aggregate risks associated with— such existing laboratories; and expanding the numbers and facilities of such laboratories; and the type of oversight needed for high-containment laboratories; and up-to-date national standards, developed by the Federal entity identified under subsection (a)— are developed by the Federal entity identified under subsection (a) in consultation with members of the scientific community, for the design, construction, commissioning, operation, and long-term maintenance of high-containment laboratories; and take into consideration applicable regulations and guidance for high-containment laboratories. Upon completion of each strategic evaluation under subsection (a), the Federal entity identified under subsection (a) shall submit to the President and the Congress a report on the results of such evaluation and include in each such report recommendations on— addressing gaps in Federal oversight of high-containment laboratories; and utilizing high-containment laboratories for protecting public health and ensuring biosafety and biosecurity in the United States. The Federal entity identified under subsection (a) shall maintain a team, to be known as the Public Health Biosafety and Biosecurity Team, to serve as a single point of contact for State, local, Tribal, and territorial agencies regarding questions relating to laboratory biosafety and biosecurity. The Federal entity identified under subsection (a) shall establish the Public Health and Biosecurity Team, as required by paragraph (1), not later than one year after such official is first designated. The Public Health Biosafety and Biosecurity Team shall be the single point of contact in the Federal Government for State, local, Tribal, and territorial agencies on— issues related to— oversight of high-containment laboratories; the impact of high-containment laboratories on public health; or connecting State, local, Tribal, and territorial officials with the relevant Federal agency or agencies on matters related to high-containment laboratories; and other issues as determined necessary by the Federal entity identified under subsection (a). The Federal entity identified under subsection (a) shall conduct a feasibility study on establishing and maintaining a database on existing high-containment laboratories in the United States for the purpose of making such database accessible to Federal, State, local, Tribal, and territorial officials. The database to be studied under paragraph (1) should be designed to include, with respect to each high-containment laboratory, the following information: The identity of the owners of the laboratory. The address of the laboratory. The status of any licensing or certification of the laboratory required under Federal, State, local, Tribal, or territorial law. Any legal violations by, and disciplinary action taken against, the laboratory. Such additional information as the Federal entity identified under subsection (a) determines appropriate to protect biosafety and biosecurity. Upon completion of the feasibility study under this subsection, the Federal entity identified under subsection (a) shall submit to the Congress a report on the results of such study. In this section, the term high-containment laboratory means laboratories that are suitable for biosafety level 3 or any higher biosafety level procedures as defined in 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).