DOD concurred with all of our recommendations. The Army’s Investigation into the May 2015 Dugway Incident

In May 2015, DOD discovered that the Life Sciences Division—currently  known as the BioTesting Division—at Dugway Proving Ground, Utah, had  inadvertently made 575 shipments from 2004 through 2015 of  incompletely inactivated Bacillus anthracis—the bacterium that causes  anthrax—to 194 laboratories and contractors worldwide (see fig. DOD  reported that it has actions under way to implement the remaining   17 recommendations. Rather than focus exclusively on the recommendations from the Army’s  2015 investigation report, the BSAT Biorisk Program Office (BBPO)  incorporated actions to implement the 2015 recommendations into  broader Army efforts to improve biosafety, biosecurity, and overall  program management. Measuring the effectiveness of each implemented  recommendation would help bolster BBPO’s existing efforts. It would also  help BBPO to better determine whether the actions taken are working,  whether there are unintended consequences, or if further action is  necessary. The Army Has Implemented a BSAT Biosafety and Biosecurity Program but Does Not Have a Completed Strategy and Implementation Plan

		The BSAT Biosafety and Biosecurity Program Is a Broad Effort to Improve Management, Coordination, Safety, and Quality Assurance

In response to the 2015 incident at Dugway Proving Ground and various  subsequent DOD and external reviews of management, operational,  coordination, safety, and quality assurance incidents between 2004 and  2015, DOD has initiated a broad range of efforts to address these types  of incidents and to improve DOD’s BSAT enterprise. The Army Has Not Fully Institutionalized Measures to Ensure the Independence of Edgewood Chemical Biological Center’s Test and Evaluation Mission

The Army has not fully institutionalized measures to ensure that its  biological test and evaluation mission remains independent from its  biological research and development mission at Edgewood Chemical  Biological Center. The memorandum of agreement does not contain, for  example, criteria that distinguish the mission requirements for operational  test and evaluation for the BioTesting Division from the mission  requirements for research and development, 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. DOD  was to report to the congressional defense committees by February 1,  2017, among other things, on the results of its study to evaluate (1) the  feasibility of consolidating covered facilities within a unified command to  minimize risk, (2) opportunities to partner with industry for the production  of BSAT and related services in lieu of maintaining such capabilities  within the Army, and (3) whether operations under the BSAT production  program should be transferred to another government or commercial  laboratory that might be better suited to produce BSAT for non-DOD  customers. However, as of March 2018, CBDP officials  acknowledged that these study efforts are still ongoing and that there are  no estimated time frames for completing any of them. The NDAA for Fiscal Year 2017 is not the first time that DOD has been  directed to review its BSAT infrastructure. Without a strategy and implementation plan, the Army may  not be able to harmonize BSAT operations to ensure safety, security, and  standardization of procedures throughout DOD’s BSAT enterprise. Without time frames for reporting on the final results  of this study, DOD is unable to provide decision makers with key  information needed to determine infrastructure requirements for the BSAT  program and contribute to federal-level efforts to determine the  appropriate number of high-containment laboratories in the United States. (Recommendation 1)
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. This report discusses the extent to which (1) DOD has  implemented the recommendations from the Army’s 2015 investigation  report and has developed an approach to measure the effectiveness of  actions taken to address the recommendations, (2) the Army has  implemented the BSAT Biosafety and Biosecurity Program and  developed a strategy and implementation plan, (3) the Army has  developed measures to ensure that its biological test and evaluation  mission remains independent under its biological research and  development mission, and (4) DOD has carried out a study and  evaluation in compliance with the requirements contained in section 218,  subsection (d), of the NDAA for Fiscal Year 2017. Appendix III: Actions Taken to Implement Recommendations from the Army’s 2015 Investigation Report as of March 2018

The National Defense Authorization Act for Fiscal Year 2017 contained a  provision for us to review the actions taken by the Department of Defense  (DOD) to address the findings and recommendations of the Army’s 2015  investigation report regarding the incident at Dugway Proving Ground,  including any actions taken to address the culture of complacency in the  biological select agents and toxins (BSAT) program that was identified in  the report.
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 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.

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.