Sec. 302. Enhancing laboratory biosecurity
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The President shall establish a permanent advisory panel to be known as the Federal Experts Security Advisory Panel to make technical and substantive recommendations on biological agent and toxin security. The members of the Panel— shall consist of the voting members appointed under subparagraph
(D)and the nonvoting members appointed under subparagraph (E); and except as provided in subparagraph (E), shall each be an official or employee of the Federal Government. The voting members of the Panel appointed under clauses (i), (v), and
(vi)of subparagraph
(D)shall serve jointly as the Co-Chairs of the Panel. The voting members of the Panel shall consist of 1 voting representative of each of the following Government entities, appointed (except with respect to the National Security Council) by the head of the respective entity: The Department of Agriculture. The Department of Commerce. The Department of Defense. The Department of Energy. The Department of Health and Human Services. The Department of Homeland Security. The Department of Justice. The Department of Labor. The Department of State. The Department of Transportation. The Department of Veterans Affairs. The Environmental Protection Agency. The National Security Council, which shall be represented by the Special Assistant to the President for Biodefense. The Office of the Director of National Intelligence. Any other department or agency designated by the Co-Chairs. The nonvoting members of the Panel shall consist of— such additional representatives of the Government entities listed in subparagraph
(D)as may be appointed by the heads of the respective entities; and a representative of the public health laboratory community or biological laboratory community (or both). The Secretary of Health and Human Services shall provide to the Panel such facilities, staff, and support services as may be necessary for the Panel to carry out its responsibilities under paragraph (2). Not later than 6 months after the date of the enactment of this section, the Panel shall, with respect to biological agent and toxin security, deliver to the Secretaries of Agriculture, Health and Human Services, and Homeland Security plurality recommendations, including any statements of dissent, concerning— the designation as highest risk of that subset of biological agents and toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act ( 42 U.S.C. 262a(a)(1) ) that presents the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effects to the economy, informed by— any biological or bioterrorism risk assessments conducted by the Department of Homeland Security and relevant assessments by other agencies; and determinations made by the Secretary of Homeland Security pursuant to section 319F–2(c)(2)(A) of such Act (42 U.S.C. 247d–6b(c)(2)(A)); the development of a set of minimum risk-based prescriptive laboratory security performance standards based on the risk at the lowest level, allowing for enhancements as risk increases; the establishment of appropriate standards and practices to improve vetting and monitoring of, and ensure reliability of, personnel with access to highest risk biological agents and toxins at facilities registered under section 351A(d) of the Public Health Service Act ( 42 U.S.C. 262a(d) ); the establishment of appropriate practices for physical security and cyber security for facilities that possess highest risk biological agents or toxins; standards for training of laboratory personnel in security measures; other emerging policy issues relevant to the security of biological agents and toxins; adequacy of information sharing protocols with biodefense and biosecurity stakeholders; and any other security standards determined necessary. The Secretaries of Health and Human Services and Agriculture, in coordination with the Secretary of Homeland Security, no later than 1 year after the date of receipt of recommendations under subsection (a)(2), shall, as appropriate, propose rules under section 351A of the Public Health Service Act ( 42 U.S.C. 262a ) establishing security standards and procedures that are specific to highest risk biological agents and toxins. The Secretaries of Health and Human Services and Agriculture, in coordination with the Secretary of Homeland Security, no later than 24 months after the date of the enactment of this section, shall promulgate final rules described in paragraph (1). To ensure that the Federal Government provides for comprehensive and effective oversight of biological agents and toxins security, the heads of the Government entities listed in subsection (a)(1)(D) shall for facilities in which the entity supports biological agent or toxin laboratory activities and by no later than 6 months after the submission of recommendations under subsection (a)(2), develop and implement a plan for the coordination of biological agents and toxins security oversight that— articulates a mechanism for coordinated inspections of and harmonized administrative practices for facilities registered under section 351A(d) of the Public Health Service Act ( 42 U.S.C. 262a(d) ), pursuant to subsection
(d)of this section; and ensures consistent and timely identification and resolution of biological agents and toxins security and compliance issues. The heads of the entities listed in subsection (a)(1)(D) shall coordinate or consolidate laboratory inspections and ensure that such inspections are conducted using a common set of inspection procedures across such entities in order to minimize the administrative burden on such laboratory. Any inspection report resulting from an inspection described in paragraph
(1)shall be available to— each Federal agency that supports biological agent or toxin laboratory activities at the laboratory that is the subject of the inspection report; and the laboratories that are the object of inspection. The Secretaries of Health and Human Services and Agriculture shall— develop a process for sharing of information pertaining to biological agents and toxins with agencies that support biological agent or toxin laboratory activities, that identifies the purpose for sharing, and a mechanism for securing, such information; share relevant information pertaining to biological agents and toxins, including identification of laboratories possessing highest risk biological agents and toxins, and compliance issues with the Secretary of Homeland Security; and share relevant information pertaining to biological agents and toxins, including identification of laboratories possessing highest risk biological agents and toxins, with appropriate State, local, and tribal government authorities, including law enforcement authorities and emergency response providers. The Secretaries of Agriculture and Health and Human Services shall ensure that any information disseminated under this section is handled consistently with— the authority of the Director of National Intelligence to protect intelligence sources and methods under the National Security Act of 1947 ( 50 U.S.C. 401 et seq. ) and related procedures or similar authorities of the Attorney General concerning sensitive law enforcement information; section 552a of title 5, United States Code (commonly referred to as the Privacy Act of 1974 ); and other relevant laws. In this section: The terms biological agent and toxin refer to a biological agent or toxin, respectively, listed pursuant to section 351A(a)(1) of the Public Health Service Act ( 42 U.S.C. 262(a)(1) ). The term highest risk means, with respect to a biological agent or toxin, designated as highest risk as described in subsection (a)(2)(A). The term Panel means the Federal Experts Security Advisory Panel under subsection (a). The term State, local, and tribal has the same meaning that term has in the Homeland Security Act of 2002 ( 6 U.S.C. 101 et seq. ).
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- 42 USC 247d–6b(c)(2)(A)
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Sec. 302
Enhancing laboratory biosecurity
Cite42 USC 247d–6b(c)(2)(A)
Cites 5Cited by 0 across 0 sources