The objectives of this project were to: 1) assess the uniform application of biosafety and biosecurity policy and directives, plans, orders, and guidance across DoD Component laboratories that were conducting research using biological select agents and toxins (BSAT) and 2) evaluate DoD biological safety and security oversight at laboratories; DoD Component biological safety and security compliance with Federal, DoD, and Service policy; and DoD and Component actions on recommendations from previous Government Accountability Office, Defense Science Board, and Defense Health Board reports.
We found that:
- DoD had not maintained biosafety and biosecurity program management, oversight, and inspections of its BSAT laboratories according to applicable Federal regulations.
- BSAT laboratories in Military Services were inspected according to different guidance, standards, and procedures, risking dangerous lapses in biosafety practices.
- Lack of coordinated oversight of DoD laboratories led to multiple, missing, and duplicative inspections, and, therefore, an excessive administrative burden that could interfere with scientific research performance.
- Inspection quality varied as inspection team members sometimes lacked necessary training or sufficient experience and expertise, or a combination of each.
- DoD did not require that deficiencies identified by inspections were tracked and remain corrected after they were initially closed.
- DoD lacked a single coordinating entity to oversee and manage biosafety and biosecurity deficiencies in high risk BSAT laboratories.
As a result, DoD BSAT laboratories have:
- used protocols that were not validated for their intended use,
- been inspected irregularly or not at all, and
- had significant deficiencies and vulnerabilities that were not corrected by DoD management.
Consequently, the health and safety of the public was put at risk of inadequate protection from exposure to biological pathogens. DoD leadership has taken actions to address the anthrax biosafety protocol failures identified at Dugway Proving Ground in May 2015, including those based on the recommendations of a Comprehensive Review Committee established by the Under Secretary of Defense for Acquisition, Technology, and Logistics. Several of the DoD leadership actions based on recommendations from the Review Committee may be difficult to implement as they appear contradictory to oversight community standards.
We recommend that the Deputy Secretary of Defense appoint a single Executive Agent responsible for biosafety and biosecurity to perform the following tasks:
- track all internal and external inspection results and ensure appropriate corrective actions are taken,
- ensure that all BSAT laboratories are inspected regularly according to a standardized set of criteria,
- coordinate external technical and scientific peer reviews, and
- develop standardized training for inspectors, and ensure inspection teams consist of personnel with appropriate experience and expertise.
We recommend that the Under Secretary of Defense for Acquisition, Technology, and Logistics:
- issue guidance that all Department of Defense BSAT laboratories implement internal technical and scientific peer review functions that address both biosafety and biosecurity issues, and
- develop implementing guidance that requires site-specific laboratory security vulnerability assessment findings be included during Biological Select Agent and Toxins laboratory inspections.
Management Comments and Our Response
The Under Secretary of Defense for Acquisition, Technology, and Logistics responded to the recommendations in this report on behalf of the Deputy Secretary of Defense, and agreed with all recommendations.
The Under Secretary of Defense for Acquisition, Technology, and Logistics stated that the Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics is drafting a DoD Directive for the DoD BSAT Biosafety and Biosecurity Program that establishes policy and designates and defines the role of the Secretary of the Army as the DoD Executive Agent for the DoD BSAT Biosafety and Biosecurity Program.
Management’s responses addressed all specifics of the recommendations in this report, and no further comments are required. We request that the draft DoD Directive be forwarded to us for review.
This report is a result of Project No. D2015-D00SPO-0054.000.