Biological Select Agents and Toxins: Actions Needed to Improve Management of DOD's Biosafety and Biosecurity Program
Highlights
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.
Recommendations
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.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Department of Defense | 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) |
DOD concurred with our recommendation. DOD monitors the effectiveness of the recommendations implemented from the Army's 2015 investigation report through 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 and updates the Executive Agent quarterly. Also, DOD issued its Biological Select Agents and Toxins Biorisk Program Office FY 20-24 Strategic Plan, which communicates goals and objectives to improve key areas associated with the Army's 2015 investigation report, including oversight, communication, transparency and inspections for the DOD BSAT Biosafety and Biosecurity Program. Also, the plan includes timeframes and metrics that evaluate tasks associated with each goal and objective. These actions meet the intent of the recommendation.
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| Department of Defense | 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) |
DOD concurred with our recommendation. The DOD Biological Select Agents and Toxins Biorisk Program Office provided GAO a copy of their FY 20-24 Strategic Plan. The plan contains a list of goals and objectives that focuses on broader efforts to improve oversight, communication, transparency and inspections of the DOD BSAT Biosafety and Biosecurity Program for the Executive Agent, and timeframes for completing the goals and objectives to achieve full implementation within five years. The plan also includes metrics aimed at evaluating tasks to ensure that they are being met and to fulfill the desired end state to strengthen DOD BSAT operations. These actions meet the intent of the recommendations.
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| Department of Defense | 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) |
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.
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| Department of Defense | 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) |
In August 2019, DOD submitted a report to the Congressional Defense Committees in response to Section 218 of the NDAA for FY 2017. The report contains the evaluation results of DOD's consolidation operations with the Chemical Biological Center's BioTesting Division (formerly Life Sciences Test Facility) at Dugway Proving Ground, UT, with operations at the Chemical Biological Center at Aberdeen Proving Ground, MD. In addition, the report recommended maintaining operations at the Navy Medical Research Center and the U.S. Army Medical Research Institute of Infectious Disease while eliminating operations at the Naval Surface Warfare Center (NSWC) in Dahlgren, VA and the U.S. Air Force Laboratory at Wright Patterson Air Force Base. The report stated that The Navy Biological Select Agent and Toxins (BSAT) research mission is unique because of the environment in which the Navy operates, so the decision was made to keep the NSWC BSAT laboratory operational, under command and control of the Navy. In addition, the report contains the results of DOD's review on partnering with industry to produce BSAT and related services in lieu of maintaining such capabilities with the Department of the Army. The Joint Program Executive Office for Chemical, Biological and Radiological Defense (JPEO-CBRND), by direction of Assistant Secretary of the Army for Acquisition, Logistics, and Technology, released two Requests for Information (RFI) in FY17 to assess private industry capability and willingness to provide standardized materials to the Government. The first RFI was released in early January 2017 and the second in June 2017. The RFIs examined potential BSAT suppliers and showed that several were identified as capable. The JPEO-CBRND also funded a study, completed in May 2017, to assess current processes and methods for implementation of new processes for the production, characterization, storage, and distribution of BSAT and derivatives. The study considered existing investments within DOD and the impacts of pursuing industry partnerships. Initial assessment suggested significant investment would be required to establish appropriate infrastructure within commercial industry, achieve the required approvals, and develop processes as necessary to replace or supplement government capability. Finally, the report includes information on the extent to which operations under the BSAT program should be transferred to another government or commercial laboratory. The report stated that historically, industry interest in the production of BSAT relevant to DOD's unique requirements has been low for several reasons, including: (1) lack of ability and willingness to synchronize internal processes and procedures and regulatory requirements with those of Army and DOD; (2) overall risk associated with the nature of Army and DOD BSAT efforts; and (3) lack of appropriate infrastructure for containment, security, and safety. Harmonization efforts in response to Executive Order 13546 were anticipated to mitigate some of these constraints and facilitate future partnerships. However, after careful analysis of the investments within DOD, the Joint Program Executive Office for Chemical, Biological and Radiological Defense divested itself of all activities associated with BSAT and non-BSAT derivatives (i.e., production, handling, storage, and distribution). The actions meet the intent of the recommendation.
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