§1527 — Title 50 War and National Defense | U.S. Code

Summary

The Secretary of Defense must run a program, through the DoD office that handles bioselect agent safety, to put quality control and quality assurance steps in place at every DoD facility that makes biological select agents and toxins. The steps must include an outside manager for QA/QC, environmental checks and inspections, rules that stop use of live agents where viability testing happens, rules that stop working on multiple organisms or strains in one biosafety cabinet, video monitoring to help improve lab practices, regular data reviews to find trends and problems early, validated production procedures so changes are checked before use, and maintenance and calibration schedules for tools, equipment, and irradiators. The Secretary may waive any of these steps if needed for national defense. The Secretary must study whether to consolidate facilities under one command, partner with industry, or move production to another government or commercial lab, and must send the study report to the congressional defense committees by February 1, 2017. The Comptroller General must send a report by September 1, 2017 reviewing DoD actions on the Army report titled "Individual and Institutional Accountability for the Shipment of Viable Bacillus Anthracis from Dugway Proving Grounds" (dated December 15, 2015), the Secretary’s progress on the QA/QC program, and an analysis of the study. Biological select agents and toxins means the agents listed in the CFR at 7 C.F.R. §331.3, 9 C.F.R. §§121.3–121.4, or 42 C.F.R. §§73.3–73.4. A covered facility means any DoD place that produces those agents or toxins.

Title 50, §1527

War and National Defense — Source: USLM XML via OLRC

(a)The Secretary of Defense, acting through the executive agent for the biological select agent and toxin biosafety program of the Department of Defense, shall carry out a program to implement certain quality control and quality assurance measures at each covered facility.

(b)Subject to subsection (c), the quality control and quality assurance measures implemented at each covered facility under subsection (a) shall include the following:

(1)Designation of an external manager to oversee quality assurance and quality control.

(2)Environmental sampling and inspection.

(3)Production procedures that prohibit operations where live biological select agents and toxins are used in the same laboratory where viability testing is conducted.

(4)Production procedures that prohibit work on multiple organisms or multiple strains of one organism within the same biosafety cabinet.

(5)A video surveillance program that uses video monitoring as a tool to improve laboratory practices in accordance with regulatory requirements.

(6)Formal, recurring data reviews of production in an effort to identify data trends and nonconformance issues before such issues affect end products.

(7)Validated protocols for production processes to ensure that process deviations are adequately vetted prior to implementation.

(8)Maintenance and calibration procedures and schedules for all tools, equipment, and irradiators.

(c)In carrying out the program under subsection (a), the Secretary may waive any of the quality control and quality assurance measures required under subsection (b) in the interest of national defense.

(d)(1)The Secretary of Defense shall carry out a study to evaluate—

(A)the feasibility of consolidating covered facilities within a unified command to minimize risk;

(B)opportunities to partner with industry for the production of biological select agents and toxins and related services in lieu of maintaining such capabilities within the Department of the Army; and

(C)whether operations under the biological select agent and toxin production program should be transferred to another government or commercial laboratory that may be better suited to execute production for non-Department of Defense customers.

(2)Not later than February 1, 2017, the Secretary shall submit to the congressional defense committees a report on the results of the study under paragraph (1).

(e)Not later than September 1, 2017, the Comptroller General of the United States shall submit to the congressional defense committees a report that includes the following:

(1)A review of—

(A)the actions taken by the Department of Defense to address the findings and recommendations of the report of the Department of the Army titled “Individual and Institutional Accountability for the Shipment of Viable Bacillus Anthracis from Dugway Proving Grounds”, dated December 15, 2015, including any actions taken to address the culture of complacency in the biological select agent and toxin production program identified in such report; and

(B)the progress of the Secretary in carrying out the program under subsection (a).

(2)An analysis of the study and report under subsection (d).

(f)In this section:

(1)The term “biological select agent and toxin” means any agent or toxin identified under—

(A)section 331.3 of title 7, Code of Federal Regulations;

(B)section 121.3 or section 121.4 of title 9, Code of Federal Regulations; or

(C)section 73.3 or section 73.4 of title 42, Code of Federal Regulations.

(2)The term “covered facility” means any facility of the Department of Defense that produces biological select agents and toxins.

Notes & Related Subsidiaries

Editorial Notes

Codification Section was enacted as part of the National Defense Authorization Act for Fiscal Year 2017, and not as part of Pub. L. 91–121, title IV, § 409, Nov. 19, 1969, 83 Stat. 209, which comprises this chapter.

Statutory Notes and Related Subsidiaries

Notification of Safety and Security Concerns at Certain Department of Defense Laboratories Pub. L. 118–31, div. A, title X, § 1089, Dec. 22, 2023, 137 Stat. 420, provided that: “(a) In General.—The Secretary of Defense shall notify the congressional defense committees [Committees on Armed Services and Appropriations of the Senate and the House of Representatives] within 7 days after ceasing operations at any Department of Defense laboratory or facility rated at biosafety level–3 or higher for safety or security reasons. “(b) Content.—The notification required under subsection (a) shall include—“(1) the reason why operations have ceased at the laboratory or facility; “(2) whether appropriate notification to other Federal agencies has occurred; “(3) a description of the actions taken to determine the root cause of the cessation; and “(4) a description of the actions taken to restore operations at the laboratory or facility.” “Congressional Defense Committees” Defined Congressional defense committees means the Committees on Armed Services and Appropriations of the Senate and the House of Representatives, see section 3 of Pub. L. 114–328, 130 Stat. 2025. See note under section 101 of Title 10, Armed Forces.

§1527 Improved biosafety for handling of select agents and toxins

Summary

Title 50, §1527

Notes & Related Subsidiaries

Editorial Notes

Statutory Notes and Related Subsidiaries

Citations & Metadata