Biological Select Agents and Toxins:
Actions Needed to Improve Management of DOD's Biosafety and Biosecurity Program
GAO-18-422: Published: Sep 20, 2018. Publicly Released: Sep 20, 2018.
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What GAO Found
The Department of Defense (DOD) has made progress by taking a number of actions to address the 35 recommendations from the Army's 2015 investigation report on the inadvertent shipments of live Bacillus anthracis (anthrax). However, DOD has not yet developed an approach to measure the effectiveness of these actions. As of March 2018, DOD reports 18 recommendations as having been implemented and 17 as having actions under way to implement them. These actions are part of a broader effort to improve biosafety, biosecurity, and overall program management. For example, in March 2016, DOD established the Biological Select Agents and Toxins (BSAT) Biorisk Program Office to assist in overseeing the BSAT Biosafety and Biosecurity Program and implementation of the recommendations. Measuring the effectiveness of each implemented recommendation would help better determine if the actions taken are working, if there are unintended consequences, or if further action is necessary.
The Secretary of the Army, as DOD's Executive Agent, has implemented a BSAT Biosafety and Biosecurity Program to improve management, coordination, safety, and quality assurance for the DOD BSAT enterprise. However, DOD has not developed a strategy and implementation plan for managing the program. Without a strategy and implementation plan, Dugway Proving Ground, Utah, and DOD's laboratory facilities that currently produce and handle BSAT may be unclear about DOD's strategy to harmonize BSAT operations to ensure safety, security, and standardization of procedures throughout DOD's BSAT enterprise.
The Army has not fully institutionalized measures to ensure that its biological test and evaluation (T&E) mission remains independent from its biological research and development (R&D) mission so that its T&E procedures are objective and reliable. In April 2016, the Army directed the transfer of the operational T&E mission from West Desert Test Center-Life Sciences Division at Dugway Proving Ground, Utah, to Edgewood Chemical Biological Center, Maryland. The Army issued a memorandum of agreement between the two entities to lay out roles and responsibilities for test processes and procedures. However, the memorandum does not distinguish T&E from R&D mission requirements, and does not contain guidelines to mitigate risks associated with potential conflicts of interest between the R&D and T&E missions. Without these measures, there is a potential risk to the independence of the T&E mission.
The National Defense Authorization Act (NDAA) for Fiscal Year 2017 required DOD to report by February 1, 2017, on the feasibility of consolidating BSAT facilities within a unified command, partnering with industry for the production of BSAT in lieu of maintaining such capabilities within the Army, and whether such operations should be transferred to another government or commercial laboratory. DOD has not completed this required study and evaluation of its BSAT infrastructure which, when complete, will affect the future infrastructure of the BSAT Biosafety and Biosecurity Program. Further, DOD officials have no estimated time frames for when DOD will complete the study and evaluation. Without time frames for completing the study and evaluation, DOD is unable to provide decision makers with key information on its infrastructure requirements.
Why GAO Did This Study
In May 2015, DOD discovered that one of its laboratories (formerly called the Life Sciences Division) at Dugway Proving Ground, Utah, had inadvertently made 575 shipments of live Bacillus anthracis—the bacterium that causes anthrax—to 194 laboratories and contractors worldwide from 2004 through 2015. A December 2015 investigation by the Army determined that there was insufficient evidence to establish a single point of failure and made recommendations for improving safety and security at DOD laboratories that handle BSAT.
The NDAA for Fiscal Year 2017 included a provision for GAO to review DOD's actions to address the Army's recommendations. GAO assessed the extent to which (1) DOD has implemented recommendations from the Army's 2015 investigation report, (2) the Army has implemented the BSAT Biosafety and Biosecurity Program and developed a strategy and implementation plan, (3) the Army's biological T&E mission is independent from its biological R&D mission, and (4) DOD has carried out a required study and evaluation. GAO reviewed DOD documents and key actions in response to the Army's recommendations and conducted site visits to DOD's BSAT laboratories.
What GAO Recommends
GAO recommends that DOD develop an approach to assess the effectiveness of the recommendations, a strategy and implementation plan for its BSAT Biosafety and Biosecurity Program, measures to ensure independence, and time frames to complete a study. DOD concurred with all four of GAO's recommendations.
For more information, contact Joseph Kirschbaum at (202) 512-9971 or KirchbaumJ@gao.gov.
Recommendations for Executive Action
Comments: DOD concurred with our recommendation. On August 13, 2019, DOD noted that the department has taken steps to implement recommendations from multiple investigation reports and the 2017 National Defense Authorization Act (NDAA) and has a systematic approach to track them through to completion. DOD will incorporate into existing processes an approach for assessing how effectively the recommendations from the Army's 2015 investigation report address the original condition and contributing factors they intended to resolve. Recommendations that are no longer considered the best option to resolve the original condition will be identified and alternative solutions developed. DOD monitors effectiveness of the solutions through requirements defined in the DOD Directive 5101.20E, Army Directive 2016-24 and its implementation guide; established working groups and councils; and the Joint Inspection Program. DOD leadership monitors implementation of solutions through the Executive Agent Responsible Official and Director of the Army Staff (DAS) and updates the Executive Agent quarterly. The department continues to utilize working groups to address and identify implementation issues as they arise. The target date for completing implementation of these actions is September 30, 2019. Awaiting final action.
Recommendation: The Secretary of the Army should ensure that The Surgeon General of the Army, as the Executive Agent Responsible Official (EARO) for DOD's BSAT Biosafety and Biosecurity Program, incorporates into existing processes an approach for assessing how effectively the recommendations from the Army's 2015 investigation report address the original condition and contributing factors that they were intended to resolve. (Recommendation 1)
Agency Affected: Department of Defense
Comments: DOD concurred with our recommendation. On August 13, 2019, DOD noted that the DOD BSAT Biorisk Program Office (BBPO) is finalizing the strategic plan with an estimated publication date of September 2019. However, the Army Directive Implementation Guide issued by the Executive Agent Responsible Official links guidance with the updated Select Agent Regulations. The Army Directive and Army Directive Implementation Guide establish a near-term strategy. The Strategic Plan includes long-term goals; objectives; external factors that can affect goals; use of metrics to gauge progress; an evaluation plan for monitoring goals and objectives; and a timeframe for completion. The DOD BBPO is routing the Strategic Plan for review and approval by the Executive Agent Responsible Official. Estimated completion date is December 2020. Awaiting final action.
Recommendation: The Secretary of the Army should ensure that The Surgeon General of the Army, as the EARO for DOD's BSAT Biosafety and Biosecurity Program, develops a strategy and implementation plan for the DOD BSAT Biosafety and Biosecurity Program that includes long-term goals, objectives, external factors that can affect goals, use of metrics to gauge progress, an evaluation plan for monitoring goals and objectives, and a time frame for completion. (Recommendation 2)
Agency Affected: Department of Defense
Status: Closed - Implemented
Comments: DOD concurred with our recommendation. The Army provided GAO with a memorandum, dated August 13, 2019, and documentation to explain the purpose for realigning the Bio Testing Division from the Research and Technology Directorate to the Operational Applications Directorate (formerly known as the Directorate of Program Integration), which is under the Army Combat Capabilities Development Command Chemical Biological Center (CCDC CBC) (formerly Edgewood Chemical Biological Center). The Army indicated in the memorandum and supporting documentation that this realignment and separation of the Bio Testing Division to the Operational Applications Directorate prevents potential risk to independence by keeping the test and evaluation mission activities separate from the research and development activities at CCDC CBC that are responsible for developing solutions being tested. Further, the Army memorandum states that the separation of the research and development and test and evaluation missions provide stakeholders confidence that biotesting procedures are objective and reliable. These actions meet the intent of the recommendation.
Recommendation: The Secretary of the Army should ensure that the Commander of Army Materiel Command establishes measures to prevent the potential risk to independence posed by transferring operational command and control of the BioTesting Division from West Desert Test Center to the Edgewood Chemical Biological Center. Such measures could include, for example, criteria that establish mission requirements for operational test and evaluation for the BioTesting Division, in accordance with DOD and Army regulations, and risk management guidelines to mitigate risks associated with potential conflicts of interest between the Edgewood Chemical Biological Center research and development mission and the BioTesting Division's test and evaluation mission. (Recommendation 3)
Agency Affected: Department of Defense
Comments: DOD concurred with our recommendation. On August 13, 2019, DOD noted that the department designated an infrastructure manager for the Chemical and Biological Defense Program (CBDP) and is implementing a process initiating infrastructure management activities for physical and intellectual infrastructure by December 31, 2018. This information will be used to identify any potential capability gaps or redundancies across the CBDP Enterprise and to support its decision and final response to Congress regarding BSAT infrastructure. A report has been drafted that outlines the steps OASD(NCB/CB) is taking to implement this recommendation and is currently in coordination across the Department. OASD(NCB/CB) anticipates submission to the congressional defense committees by the end of fiscal year 2019. Awaiting final action.
Recommendation: The Secretary of Defense should ensure that the Deputy Assistant Secretary of Defense for Chemical and Biological Defense establishes time frames to complete the study and its evaluations required by the NDAA for Fiscal Year 2017, Section 218(d), regarding the feasibility of consolidating covered facilities within a unified command, opportunities to partner with other industry for the production of BSAT, and transfer of BSAT production responsibilities. (Recommendation 4)
Agency Affected: Department of Defense