Security Standards for Safeguarding Biological Select Agents and Toxins (BSAT)
|Publication Date:||31 August 2018|
PURPOSE. This instruction:
a. Reissues DoD Directive (DoDD) 5210.88 (Reference (a)) as an instruction in accordance with the authority in DoDD 5134.01 (Reference (b)), Deputy Secretary of Defense Memorandum (Reference (c)), Deputy Secretary of Defense Memorandum (Reference (d)), Deputy Secretary of Defense Memorandum (Reference (e)) and paragraph E1.3 of DoD Instruction (DoDI) 5200.08 (Reference (f)) to establish policy, assign responsibilities, and provide procedures for:
(1) The execution of the DoD BSAT Security Program.
(2) Physical security and information security for BSAT in the possession of the DoD, and personnel reliability for Tier 1 BSAT as defined by part 73 of Title 42, Code of Federal Regulations (CFR) (Reference (g)), part 331 of Title 7, CFR (Reference (h)), and part 121 of Title 9, CFR (Reference (i)), collectively referred to in this instruction as the Select Agent Regulations (SAR).
b. Revises DoD BSAT security policy to: (1) Conform with Executive Order 13546 (Reference (j)).
(2) Implement the SAR.
(3) Implement sections 201-231 of Public Law 107-188 (Reference (k)).
c. Incorporates and cancels DoDI 5210.89 (Reference (l)).
APPLICABILITY. This instruction:
a. Applies to:
(1) OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD (referred to collectively in this instruction as the "DoD Components") that possess BSAT in quantities justified by a prophylactic, protective, or other peaceful purpose. (2) DoD entities located overseas not subject to the SAR and Reference (k) to the maximum extent possible. Where implementation of specific provisions is not feasible, alternative provisions will be documented based on host nation and sponsor requirements (whichever is most stringent) and site-specific risk assessments.
(3) Contracts that cover requirements for access to BSAT to the extent that applicable provisions are incorporated into and made a part of the contract.
b. Applies partially to DoD clinical or diagnostic laboratories and other DoD entities that voluntarily elect to register under the Federal Select Agent Program (FSAP) even though they are exempt from FSAP regulations ((referred to in paragraph 2.c.(2)) in which case application of this instruction is limited to:
(1) Maintain registration with the FSAP, adhere to applicable SAR requirements, and keep this information in the DoD BSAT database in accordance with paragraph 9(c) of Enclosure 4 of this instruction.
(2) Provide the Center for Disease Control and Prevention (CDC) or Animal and Plant Health Inspection Service (APHIS) reports and inspection results that may lead to entity closure in accordance with paragraph 2b of Enclosure 7.
c. Does not apply to: