Biological Select Agents and Toxins: Actions Needed to Improve Management of DOD's Biosafety and Biosecurity Program
Released: 2018-09-20T00:00:00

Letter

Background

Biodefense Roles and Responsibilities

Multiple federal departments and agencies—including DOD—have responsibilities as part of their missions to assess the threat of biological agents and carry out key biodefense roles as delineated in Homeland Security Presidential Directive 10, Biodefense for the 21st Century, and the National Strategy for Countering Biological Threats. Since the 2001 anthrax incident, in which powdered Bacillus anthracis spores were deliberately put into letters that were mailed through the U.S. postal system that resulted in five deaths, the federal government has experienced growth and proliferation of research programs to protect public health and agriculture in the event of a natural emergency, man- made biological incident, or act of biological terrorism. DOD laboratories that handle and research deadly pathogens are important components of the U.S. biodefense infrastructure that supports such biological research programs.

The Federal Select Agent Program

Select agent research is subject to federal oversight and regulations and is guided by the principles and practices of biosafety and biosecurity. The Federal Select Agent Program was established to regulate the possession, use, and transfer of BSAT, in response to security concerns following bioterrorism attacks in the 1990s and early 2000s. The Federal Select Agent Program is jointly managed by the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins, within the Department of Health and Human Services (HHS), and the Animal and Plant Health Inspection Service (APHIS), Agriculture Select Agent Services, within the Department of Agriculture (USDA). These two agencies jointly regulate and oversee laboratories in the United States that are registered to work with BSAT. The Federal Select Agent Program also conducts inspections of registered entities for compliance with the select agent regulations.

DOD’s Designated Infrastructure Manager for CBDP, Including BSAT

CBDP was established to develop defense capabilities to protect the warfighter from current and emerging chemical and biological threats. The CBDP Enterprise’s mission is to enable the warfighter to deter, prevent, protect against, mitigate, respond to, and recover from chemical, biological, radiological, and nuclear threats and effects as part of a layered, integrated defense. The CBDP Enterprise conducts research and develops defenses against chemical threats—such as cyanide and mustard gases—and biological threats—such as anthrax and Ebola—and tests and evaluates capabilities and products to protect military forces from them. We reported in June 2015 on the need for DOD to designate an entity to identify, align, and manage its chemical and biological defense infrastructure, which includes its BSAT-related infrastructure. We found that CBDP had not fully identified the infrastructure capabilities required to address threats, had not planned to identify potential duplication without considering information from existing federal studies, and had not updated its guidance and planning process to include specific responsibilities and time frames for risk assessments. As a result, we recommended, among other things, that DOD identify and designate an entity within the CBDP Enterprise with the responsibility and authority to lead the effort to ensure achievement of infrastructure goals, and establish time lines and milestones for achieving the goals it has identified for chemical and biological infrastructure, including the Program Analysis and Integration Office’s 2008 recommendation that the CBDP Enterprise identify its required infrastructure capabilities.

DOD concurred with all of our recommendations. In response to our recommendations, DOD, among other things, designated an infrastructure manager for CBDP and is implementing a three-phase process to identify and define the roles and responsibilities of the position by the end of 2018.

As part of its BSAT infrastructure, DOD currently has five covered facilities that contain various laboratories across the military services that possess and handle BSAT. Each of these facilities currently is registered with the Federal Select Agent Program to possess BSAT in the United States. A sixth DOD facility, the BioTesting Division at Dugway Proving Ground, Utah, is working to regain its certification as a covered facility (see fig. 1).

DOD officials said that other DOD facilities, in addition to these six, are registered with the Federal Select Agent Program to handle BSAT in an emergency outbreak situation. However, according to DOD officials, they do not currently possess BSAT. CBDP officials stated that DOD used to have more facilities that possessed and handled BSAT, but as a result of prior base realignment and closure activities, the department has consolidated its BSAT laboratory capabilities within the six facilities highlighted in figure 1, based on the unique capabilities and missions performed by each facility to support the warfighter. One of these unique capabilities, for example, is the Whole System Live Agent Test Chamber located at the BioTesting Division at Dugway Proving Ground, Utah, a one-of-a-kind chamber designed and constructed primarily for biological agent aerosol testing. For more information on the unique capabilities DOD has identified for each of the DOD laboratories that handle BSAT, scroll over figure 1 to see an interactive display of information on each facility or see appendix II for static images of this information.

BSAT Policies and Guidance

DOD and the military services have issued a number of policies and guidance aimed at ensuring safety and security for BSAT materials and establishing standards for the handling of BSAT within DOD facilities. In particular, DOD issued Instruction 5210.88, Security Standards for Safeguarding Biological Select Agents and Toxins (BSAT), which established security standards for safeguarding BSAT materials and identified roles and responsibilities for BSAT biosecurity. These include oversight responsibilities for the BSAT security program, which is led by the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs. Oversight responsibilities include establishing security standards for safeguarding BSAT, coordinating with the Federal Select Agent Program, and establishing and maintaining a database of all BSAT at DOD covered facilities.

In response to DOD Instruction 5210.88, each of the military services has received waivers or issued separate policies for securing BSAT materials. The Army has been granted a waiver to its existing policies that are inconsistent with DOD Instruction 5210.88 and, according to Army officials, is in the process of updating its policies to align with the DOD instruction. According to Navy officials, the Navy has been granted waivers while it is updating existing policies that do not currently align with DOD Instruction 5210.88. The Air Force has issued policies directing alignment with the DOD instruction. Further, a national strategy and a number of executive orders and presidential directives have been issued addressing a range of concerns, such as biological defense and safety and security for handling BSAT. For example, in 2010 the President issued an executive order directing federal agencies to harmonize their policies and guidance on BSAT to align them with the select agent regulations in order to mitigate any conflicting direction and promote research and innovation.

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. 2 for locations).

Laboratory officials at Dugway Proving Ground believed that the samples of Bacillus anthracis (see sidebar) they were shipping had been inactivated—that the hazardous effects of the pathogen had been destroyed, while the pathogen retained characteristics of interest for research purposes. DOD was inactivating samples to support research on the detection, identification, and characterization of biological threats (see fig. 3).

Anthrax is a serious infectious disease caused by the pathogen known as Bacillus anthracis. This pathogen occurs naturally in soil and commonly affects domestic and wild animals around the world. It can survive in the environment for decades. Contact with Bacillus anthracis can cause severe illness in both humans and animals. The bacteria can multiply, spread out in the body, produce toxins (poisons), and cause severe illness. Humans can be infected by breathing in spores, eating food or drinking water that is contaminated with spores, or getting spores in a cut or scrape in the skin. It is very uncommon for people in the United States to become sick with anthrax. Because Bacillus anthracis is both infectious and exceptionally resilient, it is ideally suited for potential adversaries’ biological weapons programs. Therefore, Department of Defense (DOD) biodefense officials believe that it is critical for the department to have a strong countermeasures program to protect the warfighter against this dangerous pathogen.

As of March 2018, DOD reported having implemented 18 of 35 recommendations in the Army’s 2015 investigation report. DOD reported that it has actions under way to implement the remaining 17 recommendations. The Secretary of the Army, as Executive Agent for DOD’s BSAT Biosafety and Biosecurity Program, is responsible for implementing the recommendations from the 2015 investigation report. Since 2015, the Army has taken multiple types of actions—including operational, administrative, and personnel actions—to implement the recommendations from the report.

We asked DOD to characterize the relative priority of the recommendations and describe those actions that have been taken or are under way. DOD reported that

12 recommendations were considered “high” priority, 7 of these being assessed as implemented and 5 as in progress,

18 recommendations were considered “moderate” priority, 10 of these being assessed as implemented and 8 as in progress, and

5 recommendations were considered “low” priority, 1 being assessed as implemented and 4 as in progress.

Appendix III shows the implementation status of the 35 recommendations from the Army’s 2015 investigation report that we reviewed.

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. Appendix IV describes BBPO’s roles and responsibilities. For example, Army Directive 2016-24, Department of Defense Biological Select Agent and Toxins Biosafety Program, incorporates some of the recommendations from the Army’s 2015 investigation report, such as establishing a mentorship program for laboratory staff and others who work with BSAT, as well as directing studies into the science of inactivation of Bacillus anthracis. In addition, the Army has developed implementation guidance to carry out Army Directive 2016-24, which provides clarification on the directive and on the reporting requirements to the BBPO and Executive Agent Responsible Official (hereafter referred to as the EARO) in support of the NDAA for Fiscal Year 2017.

BBPO officials told us that recommendations from the Army’s 2015 investigation report that are not incorporated in the directive have been or are being addressed through a combination of establishing working groups and, at one time, through a General Officers Steering Committee. This committee monitored implementation through updates to the EARO and the Director of the Army Staff. For example, BBPO officials told us that, from 2016 to 2017, quarterly meetings between the General Officers Steering Committee and the Director of the Army Staff were used to discuss the status of requirements in Army Directive 2016-24. These quarterly meetings also provided status updates on target completion dates for the Army’s 2015 investigation report recommendations that were incorporated in the directive. We found that the quarterly information briefs included information on the status and time frames for implementing recommendations that were incorporated into the Army directive.

BBPO Has Not Yet Developed an Approach to Measure the Effectiveness of Actions Taken to Address Recommendations

In carrying out broader biosafety efforts and implementing recommendations from the Army’s 2015 investigation report as well as recommendations from other entities, BBPO has established processes to track the status of actions that it has taken and monitor time lines for completion by responsible DOD organizations. This helps BBPO understand what actions have been taken and where they fit into a larger plan to improve biosafety at specific facilities and organizations and across the DOD BSAT enterprise.

According to Standards for Internal Control in the Federal Government, an internal control provides reasonable assurance that the objectives of an entity will be achieved, including the use of ongoing monitoring, evaluations, or a combination of the two to obtain reasonable assurance of the operating effectiveness of the entity’s internal controls over the assigned process. It also states that managers should identify, analyze, and respond to risks. Such evaluations and risk assessments are necessary to help officials understand whether the actions they have taken—or will take—address the situations that prompted the original recommendations.

We found that BBPO’s approach to planning for and executing actions to implement the 2015 Army recommendations and other recommendations fulfills the monitoring element of the internal control standards. BBPO has not, however, systematically carried out the evaluation element. Based on our review of DOD documentation, such as the quarterly information briefs on status of recommendations, and on subsequent interviews with BBPO officials, we found that BBPO has not developed an approach to assess the effectiveness of each implemented recommendation in achieving its intended purpose. According to DOD officials, BBPO has been focused on implementing not only the recommendations from the 2015 Army investigation report but also its broader efforts for the DOD BSAT Biosafety and Biosecurity Program and has not yet formalized an approach to evaluating the effectiveness of actions taken to address the recommendations from the 2015 Army investigation report.

There are many ways to assess effectiveness that could assist BBPO in improving its implementation processes. One approach we found related to DOD’s implementation of recommendations for the defense nuclear enterprise provides an example that may be useful. In 2017, we reported on DOD’s process to monitor progress and identify risks while implementing recommendations within the defense nuclear enterprise—a community that, like chemical and biological defense, operates in a low- probability, high-risk environment. In that report, we noted that DOD’s Office of Cost Assessment and Program Evaluation had developed a tracking tool that applied a systematic approach for stating the underlying problem, identifying and overseeing offices of responsibility, implementation actions, milestones, and metrics to measure the effectiveness of the actions taken toward implementing each of the recommendations to support the defense nuclear enterprise. We also found that identifying risks can help an agency to track and measure the completion of tasks over time. This example incorporates both the monitoring and evaluation elements of internal control that we discussed earlier. 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 designation of the Army as the DOD Executive Agent for the DOD Biosafety and Biosecurity Program is one example of DOD’s efforts to improve management. Prior to 2015, there was no centralized oversight authority for DOD’s BSAT enterprise. The Secretary of the Army’s designation as the Executive Agent and subsequent delegation of this authority to The Army Surgeon General has, according to BBPO and laboratory officials, resulted in improved coordination and communication across DOD and with the Federal Select Agent Program. According to these same officials, BBPO also has contributed to improved communication between DOD laboratories by establishing working groups and is developing a process for approving standard operating procedures for working with BSAT across the CBDP Enterprise.

DOD has made key safety improvements by taking a number of actions to address the incident at Dugway Proving Ground and the recommendations from the Army’s 2015 investigation report. These key safety improvements include (1) establishing a DOD Executive Agent and a support office to provide oversight, (2) implementing improved quality control and assurance standards at its covered facilities, (3) developing a new quality management system, (4) conducting additional scientific studies on BSAT inactivation, and (5) taking multiple actions to address requirements associated with Army Directive 2016-24 and the Army’s 2015 investigation report. Appendix V provides detailed information on the key safety improvements DOD has completed in response to the incident at Dugway Proving Ground and the recommendations from the Army’s investigation report.

According to BBPO officials, in addition to implementing improved quality control and assurance standards at covered facilities, they also have established a quality control and assurance working group to address and track implementation of the recommendations in accordance with the Army’s Implementation Guidance for Army Directive 2016-24 and to implement the quality control and assurance measures from section 218 of the NDAA for Fiscal Year 2017. Further, the EARO has established a BSAT Biorisk and Scientific Review Panel to review and assess biosafety and biosecurity concerns associated with new and existing procedures conducted at DOD BSAT laboratories and to provide recommendations to the EARO on their acceptability for use to enhance biosafety and biosecurity across the DOD BSAT programs.

To provide additional insights into DOD’s actions to make safety improvements and to better understand the effects of those actions on laboratory staff and operations following the 2015 incident at Dugway Proving Ground, we conducted facilitated discussions with a non- generalizable sample of supervisory and non-supervisory staff at the six DOD laboratories that handled BSAT. We used these facilitated discussions to obtain the views of those laboratory staff who have and will be implementing key biosafety and biosecurity actions from multiple sources. Appendix VI presents selected comments, organized by key themes, from laboratory staff at DOD facilities that handle BSAT in response to actions taken by DOD following the 2015 incident at Dugway Proving Ground. We heard a broad range of views on the effects of the Dugway incidents as well as the effects of subsequent actions to improve the BSAT Biosafety and Biosecurity Program. For example, some individuals were concerned about the effect of administrative requirements on the efficiency of their work, while others believed that the organizational changes made by the Army have improved communication and coordination. We did not validate any of the views expressed to us, but they may be of value to BBPO and officials throughout the BSAT enterprise in considering both how their program efforts are perceived and how best to carry them out.

BBPO Has Not Completed a Strategy and Implementation Plan to Assist the Program in the Long Term

BBPO has begun to develop a draft concept plan to establish roles and responsibilities for the BSAT Biosafety and Biosecurity Program. However, we found that BBPO has not developed a strategy or implementation plan for the long term. BBPO’s draft concept plan identified manpower and funding requirements for the BSAT Biorisk Program Office but did not go further in laying out a strategy and implementation plan. According to BBPO officials, BBPO currently is relying on DOD Instruction 5210.88 as overarching guidance for managing BSAT biosecurity operations and bringing DOD into compliance with Executive Order 13546, Optimizing the Security of Biological Select Agents and Toxins in the United States, and select agent regulations. BBPO also relies on DOD Manual 6055.18-M for managing DOD BSAT biosafety operations. In addition, DOD is in the process of drafting an overarching directive for the combined DOD BSAT Biosafety and Biosecurity Program that will be based on DOD Instruction 5210.88 and DOD Manual 6055.18-M. According to BBPO officials, BBPO plans to develop a multi-service policy to consolidate biosafety and biosecurity initiatives for combined biorisk management and replace Army Directive 2016-24 once the Army has fully implemented its directive. While efforts to develop the draft concept plan and overarching guidance are important, BBPO has not identified 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 an overall time frame for completion of a strategy and implementation plan.

According to Office of Management and Budget Circular (OMB) A-11, in addition to fulfilling the requirements of the GPRA Modernization Act of 2010, strategic planning serves a number of important management functions related to achieving an agency’s mission. For example, strategic planning is a valuable tool for communicating a vision for the future and should include goals and objectives that align with resources and guide decision making to accomplish priorities and improve outcomes. An overall strategy would also help to prioritize funding; accomplish priorities to improve outcomes; and coordinate biosafety and biosecurity protocols, practices, and procedures to achieve harmonization across the military services and the DOD BSAT enterprise. To accomplish these things, a strategy and implementation plan can include such things as long-term goals, objectives, external factors that can affect goals, use of metrics to gauge progress, and a time frame for completion.

BBPO officials acknowledged that they need a strategy and implementation plan for the BSAT Biosafety and Biosecurity Program. They said that once they complete the concept plan, they will develop a strategy that will include specific goals and tasks to support programmatic efforts. They explained that they have not been able to develop a strategy and implementation plan because BBPO still is organizing the office and carrying out its other responsibilities while working toward obtaining stakeholder support for the program.

As DOD completes a concept plan for the program and turns its attention to a strategy and implementation plan for the program over the long term, BBPO has an opportunity to incorporate the following key elements typically found in such strategies and implementation plans and specified in OMB guidance: long-term goals, objectives, external factors that can affect goals, use of metrics to gauge progress, evaluation of the plan to monitor goals and objectives, and an overall time frame for completion of the strategy and implementation plan. Without a strategy and implementation plan, Dugway Proving Ground and DOD’s currently covered facilities may not be able to determine how to inform DOD’s long- term planning efforts. In addition, components of the DOD BSAT enterprise may remain unclear about the department’s strategy to harmonize BSAT operations to ensure safety, security, and standardization of procedures throughout DOD’s BSAT enterprise. A strategy and implementation plan could also help ensure unity of command among the military services to employ department-wide policies and procedures for managing the biosafety and biosecurity of BSAT. They also could help DOD to identify the capabilities necessary to support laboratory improvements, mitigate biological mishaps similar to the 2015 incident at Dugway Proving Ground, and allocate resources that support the 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. This is important for preventing undue influence of test and evaluation procedures on research and development procedures, and vice versa. In April 2016, the Army issued General Order 2016-04 in response to a recommendation from the Army’s Biosafety Task Force, which directed the transfer of the West Desert Test Center – Life Sciences Division at Dugway Proving Ground, Utah, and its reassignment to the U.S. Army Materiel Command-Research, Development and Engineering Command – U.S. Army Edgewood Chemical Biological Center at Aberdeen Proving Ground, Maryland. This transfer took place in July 2016, and the former Life Sciences Division was subsequently renamed the BioTesting Division. Edgewood Chemical Biological Center’s traditional mission primarily is focused on research and development, while the West Desert Test Center’s traditional mission is focused on test and evaluation.

DOD subsequently reported to the congressional defense committees on April 10, 2017, that it had realigned the BioTesting Division in order to place it under staff with more experience in handling BSAT. According to the CBDP’s 2017 Annual Report to Congress, the realignment of the BioTesting Division will enable tracking, reporting, and meeting of audit requirements within an approved framework for managing governance, risks, and compliance. Figure 4 illustrates the transfer of command and control of the BioTesting Division.

Officials at Edgewood Chemical Biological Center identified a number of steps they have taken and plan to take to address concerns related to potential conflict of interest, including the following: In June 2016, the Army Test and Evaluation Command and Army Research, Development and Engineering Command signed a memorandum of agreement addressing reassignment of the BioTesting Division that lays out roles and responsibilities for test processes and procedures between the two entities. The memorandum also notes that the Research, Development and Engineering Command will develop a mitigation strategy for conflicts of interest when Edgewood Chemical Biological Center is the developer and the BioTesting Division is the tester.

In November 2017, Edgewood Chemical Biological Center elevated the BioTesting Division from a branch to a division to raise its visibility and alleviate concerns about independence between the test and evaluation functions and the research and development functions of Edgewood Chemical Biological Center.

However, as of March 2018, the Army has not institutionalized measures, such as policies, standard operating procedures, protocols, and roles and responsibilities to ensure independence between the biological research and development mission and the test and evaluation mission. Specifically, the Army has not provided any measures beyond the memorandum of agreement that acknowledged the potential for conflict of interest, such as the conditions under which one or more officials—even without intent—exercises undue influence of test and evaluation mission procedures on research and development procedures. The Army also recognizes the need for a mitigation strategy—to ensure independence between the biological research and development function and the test and evaluation function that takes the transfer of command and control into account. 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.

Army officials explained that a mitigation strategy has not been developed—and that there is no time frame for developing such a strategy—because there is no testing of BSAT materials under way at the BioTesting Division, since its BSAT registration has been withdrawn. According to Army officials, this condition could last for at least 1 to 2 years. While a mitigation strategy to prevent potential conflict of interest is envisioned by the memorandum of agreement, Edgewood Chemical Biological Center officials currently are focused on re-registering the BioTesting Division with the Federal Select Agent Program and bringing it back up to full operational capability. A senior official at Edgewood Chemical Biological Center acknowledged that the risk to independence between Edgewood Chemical Biological Center and the BioTesting Division is an issue that remains unresolved and there are currently no measures in place to prevent potential conflict of interest.

According to Army Regulation 73-1, Test and Evaluation: Test and Evaluation Policy, independence is important to ensure that the decision maker is provided with, for example, unbiased, objective advice about the status of the development of a system. In addition, as we have reported, independence between research and development functions and test and evaluation functions is key to the effectiveness of operational test and evaluation. We have reported long-standing conflicts between the research and development mission and the test and evaluation mission when there is a lack of independence, including (1) how many and what types of tests to conduct; (2) when testing should occur; (3) what data to collect, how to collect it, and how best to analyze it; and (4) what conclusions are supportable given the analysis and the limitations of the test program.

One example where the Army considered a potential conflict of interest was between the Army Test and Evaluation Command’s chemical test and evaluation mission and Edgewood Chemical Biological Center’s chemical research and development mission. Specifically, Army Directive 2016-24 directed the Army Test and Evaluation Command to conduct a separate evaluation to determine whether to transfer the “remaining elements,” that is, the chemical mission, from West Desert Test Center to Edgewood Chemical Biological Center. Officials from the Army Test and Evaluation Command stated that after developing alternative courses of action, they decided—in contrast to their decision on the biological mission—to keep the chemical mission under the Army Test and Evaluation Command rather than transferring it to the Edgewood Chemical Biological Center. According to officials at the Army Test and Evaluation Command, the transfer of operational command and control of their chemical mission could create an independence issue by placing the chemical test and evaluation function within the same command as the research and development function. The chemical mission represents a major operational command and control element of the Army Test and Evaluation Command.

Without measures in place to preserve independence—such as criteria that establish mission requirements for operational test and evaluation for the BioTesting Division or risk management guidelines—there is a potential risk to the independence of the testing and evaluation mission conducted by the BioTesting Division. For example, the BioTesting Division might be compelled to prioritize the testing of Edgewood Chemical Biological Center products over those of other DOD and non- DOD customers. Officials in the Army Test and Evaluation Command stated that the transfer of the biological test and evaluation mission may increase the complexity of the evaluation mission by requiring additional coordination. Furthermore, the BioTesting Division’s procedures on particular efforts could be influenced, resulting in test and evaluation that may not be objective or reliable. Without developing measures to prevent conflicts of interest, the Army will not have reasonable assurance of the independence of the BioTesting Division’s test and evaluation mission.

DOD Has Not Completed the Study and Evaluation Required by the NDAA for Fiscal Year 2017 to Determine Specific Infrastructure Needs for the BSAT Program

DOD has not completed its BSAT infrastructure study to determine its infrastructure needs, as required by the NDAA for Fiscal Year 2017. 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. Moreover, Standards for Internal Control in the Federal Government provides specific guidance to federal agencies on how to communicate clearly defined objectives that are to be achieved— including time frames for completing those objectives—and to inform decision makers in a timely manner.

DOD provided a report to the congressional defense committees on April 10, 2017, stating that the department is still identifying its BSAT infrastructure requirements. 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. DOD officials stated that they are focusing on identifying enterprise-wide infrastructure for CBDP, of which BSAT infrastructure is just one part. Officials explained that they have prioritized their efforts to first address the recommendations from our 2015 report, which included calling for DOD to designate an entity to take responsibility for CBDP Enterprise infrastructure. CBDP officials stated that when they established the infrastructure manager position, they decided to study CBDP Enterprise infrastructure from a “clean slate” and leverage lessons learned from previous studies. According to DOD officials, this information will be used to identify any capability gaps, right-size the CBDP Enterprise infrastructure, and support DOD’s final report to Congress regarding BSAT infrastructure.

Regarding DOD’s first required task—to study the feasibility of consolidating covered facilities within a unified command to minimize risk—DOD officials stated that study efforts are ongoing and highlighted initial consolidation actions the department has taken. Specifically, DOD officials stated that (1) DOD had established the Secretary of the Army as Executive Agent to further consolidate command oversight of DOD’s BSAT Biosafety and Biosecurity Program and (2) the Army had transferred the command and control of the BioTesting Division from the Army Test and Evaluation Command to Edgewood Chemical Biological Center, as previously discussed.

Regarding DOD’s second required task, DOD officials stated that the Army and DOD have not yet begun any specific studies on opportunities to partner with industry to produce BSAT and related services as an alternative to maintaining these capabilities within the Army. CBDP officials stated that they continually look for opportunities to partner with industry on production. CBDP officials told us that they plan to determine if there are opportunities to partner with industry after the CBDP Enterprise-wide study effort is completed. In the meantime, officials highlighted that the Army’s Defense Biological Product Assurance Office within the Joint Program Executive Office for Chemical and Biological Defense—formerly known as the Critical Reagents Program—has taken action to study its office’s BSAT-related commercial product line, which has resulted in the office divesting itself of inactivated BSAT materials.

Regarding the third required task, the NDAA for Fiscal Year 2017 required DOD to study whether BSAT production operations should be transferred to another government or commercial laboratory that might be better suited to produce BSAT for non-DOD customers. DOD reported that it has taken steps to support a future decision on this issue and, according to DOD officials, once it has completed the CBDP Enterprise- wide study of infrastructure capabilities and capacity, it will determine whether the BSAT community needs to transfer any part of its production to another entity. With regard to the production of BSAT for non-DOD customers, Army officials stated that when the BioTesting Division at Dugway Proving Ground becomes fully operational and re-registers with the Federal Select Agent Program in fiscal year 2019, it will no longer be producing and shipping BSAT to non-DOD customers. The Army took steps to address the issue prior to the NDAA for Fiscal Year 2017. Specifically, in August 2015, the Army established a Biosafety Task Force working group that examined, among other things, DOD’s covered facilities and options for locations for producing BSAT. Subsequently, in February 2016, the Army recommended that additional analysis be conducted before any decision is made to change the current BSAT laboratory infrastructure. Appendix VII shows what DOD has reported and completed in response to the requirements in the NDAA for Fiscal Year 2017.

The NDAA for Fiscal Year 2017 is not the first time that DOD has been directed to review its BSAT infrastructure. Biosafety, biosecurity, and biodefense issues have been long-standing concerns for the nation. We found that the federal government—including DOD—has spent over a decade studying biosafety and biosecurity issues, including BSAT infrastructure. DOD has contributed to and is continuing to support a number of federal efforts regarding size, safety, security, and oversight of high-containment laboratories across the United States, including the efforts of the Federal Experts Security Advisory Panel and Fast Track Action Committee to examine the size and scope of laboratories working with BSAT across the United States. Appendix VIII describes and provides a summary of selected federal panels, task forces, and working groups that have examined biosafety, biosecurity and biodefense issues since 2004. (Our prior reports related to these matters are included in Related GAO Products at the end of this report.)

According to CBDP officials, once CBDP gathers information on the capacity and needs of its enterprise-wide infrastructure and determines where there are capability gaps, it anticipates providing a report to the congressional defense committees. These officials said that the report will provide information on whether DOD should consolidate or transfer infrastructure and opportunities to partner with industry on BSAT. The EARO has periodically met with congressional authorizers, according to BBPO officials, to provide programmatic updates on the DOD BSAT Biosafety and Biosecurity Program. However, CBDP officials stated that they have not provided an update to the congressional defense committees on the results of the study efforts since they issued their preliminary report on April 10, 2017. In addition, CBDP officials told us that they do not have an estimated time frame for when they will be able to provide the final report on the results of the study of BSAT infrastructure. DOD has reported that its mandated study efforts on BSAT-related infrastructure still are ongoing because DOD is focused first on identifying CBDP Enterprise-wide infrastructure and has no estimated time frames for completing the mandated study. Unless DOD establishes time frames for finalizing its study, decision makers will not have reasonable assurance that DOD is taking the necessary steps in a timely manner to provide the required BSAT infrastructure CBDP needs to support the warfighter.

Conclusions

The inadvertent shipments of incompletely inactivated Bacillus anthracis from Dugway Proving Ground, according to the Army’s 2015 investigation report, constituted serious breaches of regulations and raised biosafety and biosecurity concerns. Since then, DOD has taken steps to improve biosafety and biosecurity and made significant progress in addressing the recommendations from the Army’s investigation report. The department currently has an opportunity to take several additional management actions that, if implemented fully, will help it capitalize on the progress that it has made. Addressing the gap in assessing how effectively the recommendations and actions taken address the original condition and contributing factors they were intended to resolve would bolster the Army’s long-term efforts. The Army could incorporate such an approach into its existing processes to monitor the implementation of recommendations from the Army’s 2015 investigation report.

The Army clearly has a concept in mind for the BSAT Biosafety and Biosecurity Program. However, that concept does not constitute a strategy and implementation plan that identifies specific long-term goals, objectives, external factors that can affect goals, and tasks to support programmatic efforts through the use of metrics to gauge progress; milestones; an evaluation of the plan; and an overall time frame for completion. 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.

The Army recognizes that the transfer of operational command and control of the BioTesting Division from West Desert Test Center at Dugway Proving Ground, Utah, to Edgewood Chemical Biological Center at Aberdeen Proving Ground, Maryland, could result in unintended consequences, such as a potential risk to the independence of the testing and evaluation mission. However, although Army officials said they intend to develop a strategy to mitigate this risk, there is no time frame for doing so, because there is no testing under way at the BioTesting Division and there will be none for at least 1 to 2 years. This hiatus in testing should not preclude Army efforts to develop a mitigation strategy. Without measures in place to prevent or mitigate a risk to independence, the transfer of operational command and control could ultimately compromise the quality of future technologies used by the warfighter.

Finally, DOD is focusing on identifying the enterprise-wide infrastructure necessary for CBDP. However, it has not yet determined time frames for completion of the study required by the NDAA for Fiscal Year 2017 related to consolidation of command, transfer of BSAT production responsibilities, and opportunities to partner with industry for the production of BSAT. 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.

Recommendations for Executive Action

We are making the following four recommendations to the 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, 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)

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)

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)

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 Comments and Our Evaluation

In written comments on a draft of this report, DOD concurred with all four of our recommendations, discussed actions it is taking and plans to take to implement them, and provided target dates for completing implementation of these actions. The full text of DOD’s written comments are reprinted in appendix IX. DOD also provided us with several technical comments, which we incorporated in the report, as appropriate. We believe these actions, if fully implemented, will address our recommendations.

USDA and HHS did not provide formal agency comments on a draft of this report, but provided us with a technical comment, which we incorporated in the report, as appropriate.

We are sending copies of this report to the congressional defense committees as well as other appropriate congressional committees; the Secretaries of Defense, Agriculture, and Health and Human Services; the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs; the Deputy Assistant Secretary of Defense for Chemical and Biological Defense; the Department of Defense Inspector General; the Secretaries of the Army, the Air Force, and the Navy and the Commandant of the Marine Corps; the Directors, Centers for Disease Control and Prevention and Animal and Plant Health Inspection Service; and other cognizant officials, as appropriate. In addition, the report is available at no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions concerning this report, please contact Joseph Kirschbaum at (202) 512-9971 or KirschbaumJ@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix X.

Appendix I: Objectives, Scope, and Methodology

The National Defense Authorization Act (NDAA) for Fiscal Year 2017 included a provision for us to report on the Department of Defense’s (DOD) actions to address findings and recommendations of the Army’s December 2015 investigation report (hereafter, the Army’s 2015 investigation report) regarding the inadvertent shipment of incompletely inactivated Bacillus anthracis from Dugway Proving Ground, Utah. It also included a provision for us to report on DOD’s efforts to implement quality control and assurance measures for the department’s Biological Select Agents and Toxins (BSAT) Biosafety and Biosecurity Program, among other things. 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.

To determine how 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, we reviewed the Army’s 2015 investigation report recommendations and assessed the subsequent actions that DOD had taken to address those recommendations. To determine whether specific recommendations have been addressed, we analyzed guidance that DOD and the Army issued to instruct department and military service activities on roles and responsibilities and implementation efforts to support DOD’s BSAT Biosafety and Biosecurity Program, such as DOD Instruction 5210.88, Security Standards for Safeguarding Biological Select Agents and Toxins (BSAT); Army Directive 2016-24, Department of Defense Biological Select Agent and Toxins Biosafety Program; and Implementation Guidance for Army Directive 2016-24. We also analyzed supporting documentation from DOD officials to demonstrate how those specific recommendations were addressed.

As of March 2018, DOD had designated a priority level and had updated the completion status of its implementation for each of the 35 of 39 recommendations from the Army’s 2015 investigation report that we reviewed. This update and priority level designation was conducted at our request. We also asked that DOD provide us with milestones and risk assessments associated with the implementation of the recommendations from the Army’s investigation report. However, DOD was unable to provide this information. (We did not review the 4 recommendations in the investigation report that pertain to individual accountability.) We interviewed cognizant DOD and military service officials to obtain their perspectives on efforts to address the recommendations in response to the 2015 incident at Dugway Proving Ground. In addition, we reviewed Standards for Internal Control in the Federal Government and DOD Instruction 5010.40, Managers’ Internal Control Program Procedures to identify criteria for communicating quality information and performing monitoring and reporting activities.

To determine the extent to which the Army has implemented the BSAT Biosafety and Biosecurity Program and developed a strategy and implementation plan, we obtained documentation from DOD officials on current policies, procedures, and directives identifying oversight and governance authorities involved in supporting DOD’s BSAT Biosafety and Biosecurity Program. Also, we obtained examples of working groups responsible for developing quality control and assurance guidance and standard operating procedures for working with BSAT in DOD laboratories and across the Chemical and Biological Defense Program (CBPD) Enterprise. In addition, we compared the actions of the BSAT Biorisk Program Office (BBPO), such as developing the draft Department of Defense Biological Select Agents and Toxins Biorisk Program Office Concept Plan, to leading practices for sound management identified in the GPRA Modernization Act of 2010, and the Army’s 2015 investigation report recommendations. Further, we interviewed DOD officials from the military services to determine their strategies and efforts in supporting DOD’s plans to effectively manage DOD’s BSAT Biosafety and Biosecurity Program. We also interviewed cognizant officials to determine any biosafety and biosecurity improvements made since the 2015 incident at Dugway Proving Ground.

We toured all six DOD BSAT laboratory facilities, five of which currently are responsible for handling BSAT, to observe the current physical space—both operational and under construction—for handling and testing BSAT. These site visits were conducted at the (1) BioTesting Division, Dugway Proving Ground, Utah; (2) Edgewood Chemical Biological Center, Aberdeen Proving Ground, Maryland; (3) U.S. Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland; (4) Naval Medical Research Center, Fort Detrick, Maryland; (5) Chemical, Biological, and Radiological Defense Division, Naval Surface Warfare Center – Dahlgren Division, Dahlgren, Virginia; and (6) 711th Human Performance Wing, Wright – Patterson Air Force Base, Ohio.

We also conducted facilitated discussions between September 2017 and November 2017 with groups of laboratory non-supervisory staff at each of the six DOD BSAT laboratories—five of which currently are responsible for handling BSAT—to obtain their views of the effects of the 2015 discovery at Dugway Proving Ground and the subsequent investigation and management actions to respond to identified problems. Generally, discussion groups are designed to obtain in-depth testimonial information about participants’ views, opinions, and/or experiences on specific issues, which cannot be easily obtained from single interviews. In preparation for each discussion group, we asked the leadership at each of the six DOD laboratories to distribute our e-mail inviting all laboratory staff to participate in an on-site discussion group. These small groups consisted of self-selected volunteers, and were not random samples of research staff at each of these laboratories. The number of non-supervisory laboratory staff participants in each group ranged from 3 to 17 and totaled 44 participants.

A GAO team member facilitated each discussion group, using a structured discussion guide with open-ended questions. The team did not record the discussions. Instead, multiple GAO team members took notes of the discussion, without ascribing comments to specific individuals.

We later summarized the information collected for each discussion group and identified recurring themes. We did not design these discussion groups to provide results that were generalizable to the whole research staff at each laboratory. Laboratory staff who did not participate in these discussion groups may have different opinions and observations from those who participated in our discussion groups. Moreover, while we designed our discussion method to encourage participants to offer whatever comments they wished, we cannot assume that participants mentioned all of the effects that may have influenced their laboratory activities since 2015.

We also reviewed our prior work on the management of hazardous biological agents in high-containment laboratories at federal departments and agencies, including DOD. A list of related GAO products on high- containment laboratories is included in the Related GAO Products pages at the end of this report.

To examine the extent to which DOD has developed measures to ensure that the BioTesting Division’s test and evaluation mission remains independent from the research and development mission that resides at Edgewood Chemical Biological Center, we reviewed and compared Army Regulation 73-1 on testing and evaluation to Army General Order 2016-04, which first directed the transfer of the Life Sciences Division— later renamed the BioTesting Division—from the Army Test and Evaluation Command to Edgewood Chemical Biological Center. We also compared AR 73-1 to Army Directive 2016-24, Department of Defense Biological Select Agent and Toxins Biosafety Program, which provided additional guidelines for this transfer. We also reviewed the memorandum of agreement between the Army Test and Evaluation Command and the Army Research, Development and Engineering Command to assess plans, roles, and responsibilities for transfer and reassignment of the BioTesting Division from the West Desert Test Center to the Edgewood Chemical Biological Center. We also conducted interviews with senior staff at the BioTesting Division, the West Desert Test Center, and the Edgewood Chemical Biological Center to determine what procedures are in place to ensure that the BioTesting Division’s test and evaluation activities are not being influenced by the Edgewood Chemical Biological Center’s research and development efforts.

To examine the extent to which 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, we compared the relevant requirements from the NDAA for Fiscal Year 2017 with DOD’s April 10, 2017, report to the congressional defense committees to determine whether the report included all of the required elements concerning consolidation, transfer, and opportunities to partner with industry on the production of BSAT. We also obtained—through interviews with agency and written responses—the status of DOD’s efforts to address NDAA for Fiscal Year 2017 concerning infrastructure requirements for the BSAT program and enterprise-wide infrastructure for CBDP. We reviewed the Standards for Internal Control in the Federal Government to identify criteria providing guidance to federal agencies to communicate clearly defined objectives that are to be achieved, including time frames for completing those objectives and informing decision makers.

Information used in our analysis primarily covers the period from May 2015 through July 2018 and the information is the most recent available. We included budget information from fiscal year 2016 to fiscal year 2018. To conduct our work, we obtained documentation and interviewed cognizant officials from DOD organizations, offices, and military commands responsible for funding, managing, and overseeing the production, handling, testing, and shipment of BSAT; the Departments of Health and Human Services (HHS) and Agriculture (USDA) agencies that manage the Federal Select Agent Program, which jointly regulate and oversee covered entities in the United States that are registered to possess, use, and transfer BSAT; and all six DOD BSAT laboratories, five of which currently are responsible for handling BSAT. See below for a complete list of organizations and agencies.

Department of Defense

Department of Agriculture

Department of Health and Human Services

Centers for Disease Control and Prevention, Atlanta, Georgia We conducted this performance audit from May 2017 to September 2018 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

Appendix II: Static Images and Information for Map of Department of Defense Biological Select Agents and Toxins Laboratories

ECBC fosters research, development, testing, and application of technologies for protecting warfighters, first responders, and the nation from chemical and biological warfare agents. ECBC currently is developing better ways to remotely detect these chemical and biological materials and technologies to counter everything from homemade explosives to biological aerosols to traditional and non-traditional chemical hazards.

USAMRIID’s mission is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents. USAMRIID has the largest BSAT program within DOD and is committed to protecting U.S. Armed Forces from biological threats worldwide by conducting a range of efforts in the research and development of medical countermeasures and other technologies to prevent or mitigate the health effects of biological agents and emerging diseases.

ECBC BioTesting Division, Dugway Proving Ground’s primary mission is to support the Chemical Biological Defense Program through test and evaluation of biological systems, methodologies, and any associated need that requires biological capabilities. ECBC Dugway possesses the Whole System Live Agent Test Chamber, a high capacity, one-of-a-kind biological agent aerosol containment chamber designed and constructed primarily for biological warfare agent aerosol-detection system testing.

The Chemical, Biological, Radiological Defense Division at NSWCDD provides full-spectrum life cycle support for chemical, biological, and radiological detection, protection, decontamination, and modeling and simulation systems. This mission includes shipboard, fixed-site, and expeditionary chemical, biological, and radiological defense applications. NSWCDD maintains the only Navy Biological Safety Level-3 laboratory devoted to non-medical chemical, biological, and radiological defense applications, and is a leader in chemical and biological decontamination research, centering on the decontamination of Bacillus anthracis.

The Biological Defense Research Directorate at the Naval Medical Research Center serves as a national resource providing testing and analysis for the presence of potential biological hazards. The researchers are considered leaders in the field of detection, including hand-held assays, molecular diagnostics, and confirmatory analysis.

The 711th Human Performance Wing conducts research on technologies for the rapid detection of chemical, biological, and radiological events; hyperbaric medical research; and light, durable intensive care capabilities for aeromedical evacuation. It also has the nation’s only Radiological Assessment Teams available for 24/7 deployment.

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.

As of March 2018, DOD had designated a priority level and had updated the completion status of its implementation for each of the 35 of 39 recommendations from the Army’s 2015 investigation report that we reviewed. This update and priority level designation was conducted at GAO’s request. We also asked that DOD provide us with milestones and risk assessments associated with the implementation of the recommendations from the Army’s investigation report. However, DOD was unable to provide this information. We did not review the 4 recommendations in the investigation report that pertain to individual accountability. Of the 35 recommendations, DOD officials identified 12 as high priority, 18 as moderate priority, and 5 as low priority. DOD officials also provided us with an update of the completion status for implementation of each of the recommendations. Of those 35 recommendations, DOD officials indicated that 18 had been completed and 17 were in progress. (We did not independently assess whether each recommendation and DOD’s subsequent actions addressed the problems identified in the Army’s report.) Table 2 lists the 35 recommendations (tasks) by category, the priority assigned to each recommendation by DOD, the reported actions DOD has taken to address them, and the completion status DOD has reported for each as of March 2018.

Appendix IV: Delegation of Authority for the Biological Select Agents and Toxins Biosafety and Biosecurity Program

The Deputy Secretary of Defense designated the Secretary of the Army on July 23, 2015, as the Executive Agent for the Department of Defense’s (DOD) Biological Select Agents and Toxins (BSAT) Biosafety Program. According to DOD Instruction 5210.88, the Secretary of the Army is responsible for performing technical reviews and conducting inspections, and harmonizing protocols and procedures across DOD laboratories that handle BSAT.

DOD used a sequential delegation of authority to establish leadership roles and responsibilities initially for the DOD BSAT Biosafety Program and subsequently for the DOD BSAT Biosecurity Program. First, on October 26, 2015, the Secretary of the Army designated The Surgeon General of the Army as the Executive Agent Responsible Official (EARO) for the DOD BSAT Biosafety Program to consolidate oversight of BSAT biosafety operations across the department. Second, on December 9, 2016, The Surgeon General of the Army further delegated EARO authority to the Commanding General, U.S. Army Medical Research and Materiel Command, for the DOD BSAT Biosafety Program. Third, on January 3, 2017, the Deputy Secretary of Defense designated the Secretary of the Army as the DOD Executive Agent for the BSAT Biosecurity Program. Fourth, on March 31, 2017, the Secretary of the Army further designated The Surgeon General of the Army as the EARO for the DOD BSAT Biosecurity Program. Finally, on May 30, 2017, The Surgeon General of the Army delegated EARO responsibility for the DOD BSAT Biosecurity Program to the Commanding General, U.S. Army Medical Research and Materiel Command.

Army Directive 2016-24, Department of Defense Biological Select Agent and Toxins Biosafety Program, directs The Surgeon General of the Army to coordinate with the Office of the Deputy Assistant Secretary of Defense for Chemical and Biological Defense for requirements and resources— including force structure, manpower, and infrastructure—and to prioritize resources for research requirements to advance the field of BSAT biosafety. Figure 10 shows the alignment and organization of offices within DOD and the military services that are responsible for carrying out and supporting the Chemical and Biological Defense Program Enterprise.

According to BSAT Biorisk Program Office (BBPO) officials, BBPO was established in March 2016 to support the EARO in its oversight of DOD’s BSAT Biosafety and Biosecurity Program and implementation of tasks and recommendations in Army Directive 2016-24. BBPO manages a scientific review panel, inspection of DOD laboratories, harmonization of DOD’s BSAT-related regulations and procedures, and coordination of interaction and information with the Federal Select Agent Program. BBPO also is responsible for establishing a system to track and manage BSAT and BSAT-related products across DOD, providing oversight for laboratory biosafety, and advancing BSAT-related scientific research to address knowledge gaps. According to DOD officials, in fiscal year 2016, BBPO received approximately $805,000 for operation costs; in fiscal year 2017, BBPO received approximately $2 million. In addition, in fiscal year 2018, BBPO received approximately $2 million.

As part of BBPO’s oversight responsibilities, it acts as a single point of contact for coordinating with the Federal Select Agent Program. In June 2017, the EARO and the directors of the Centers for Disease Control and Prevention, Division of Select Agents and Toxins, and the Animal and Plant Health Inspection Service (APHIS), Agriculture Select Agent Services, on behalf of the Federal Select Agent Program, executed a memorandum of understanding that articulates agency responsibilities. This memorandum includes (1) oversight coordination, (2) Centers for Disease Control and Prevention and APHIS notifying DOD BSAT Biosafety and Biosecurity Programs of any referrals of a DOD-registered entity to the Department of Health and Human Services Office of Inspector General that may involve compliance violations with select agent regulations, and (3) facilitating coordinated inspections. For example, according to BBPO officials, BBPO receives every inspection report and reviews it for DOD-wide implications.

The Army has established a joint service inspection program that is led by the Department of the Army Inspector General. That office, according to BBPO officials, has worked closely with the Federal Select Agent Program in coordination with BBPO to enhance the effectiveness of joint inspections and unannounced or short-notice inspections. According to an Army official, the Department of the Army Inspector General coordinates with the other military services’ Inspectors General, who identify subject matter experts with operational experience to serve on every joint service inspection team.

In addition, BBPO officials told us that, as part of its oversight and coordination responsibilities, the office established the BSAT Biorisk and Scientific Review Panel, which was formally chartered in August 2017. This panel is charged with convening at least twice a year to review and assess biosafety, biosecurity, and technical concerns associated with currently established and new procedures conducted at DOD BSAT laboratories. The panel will review and assess scientific evidence that supports the mitigation of biosafety risks and provide recommendations to the EARO on approval of new or existing laboratory procedures. It also serves in an advisory capacity to the EARO on any matters that pertain to biosafety and biosecurity associated with BSAT-related research.

Appendix V: The Department of Defense Has Made Key Safety Improvements by Implementing Recommendations

The Department of Defense (DOD) has made key safety improvements by taking a number of actions to address the incident at Dugway Proving Ground and the recommendations from the Army’s 2015 investigation report. Key safety improvements include (1) establishing a DOD Executive Agent and a support office to provide oversight, (2) implementing improved quality control and assurance standards at its covered facilities, (3) developing a new quality management system, (4) conducting additional scientific studies on biological select agents and toxin (BSAT) inactivation, and (5) taking multiple actions to address Army Directive 2016-24 and the Army’s 2015 investigation report. These safety improvements are discussed below in more detail.

DOD Has Established an Executive Agent for DOD’s BSAT Biosafety and Biosecurity Program

One of the key safety improvements DOD took in response to the incident at Dugway Proving Ground was to establish an Executive Agent for the BSAT Biosafety and Biosecurity Program (see appendix IV). Specifically, at the direction of the Deputy Secretary of Defense, the Secretary of the Army was designated in July 2015 as the Executive Agent for DOD’s BSAT Biosafety Program, and subsequently in January 2017 as the Executive Agent for the DOD BSAT Biosecurity Program. In October 2015, the Secretary of the Army further designated The Surgeon General of the Army as the Executive Agent Responsible Official for the DOD BSAT Biosafety Program to consolidate oversight of BSAT biosafety operations across the department. The Secretary of the Army, as outlined in DOD Instruction 5210.88, is responsible for performing technical reviews, conducting inspections, and harmonizing protocols and procedures across DOD laboratories that handle BSAT.

DOD Has Improved Quality Control and Assurance at Dugway Proving Ground and Currently Covered Facilities

Another key safety improvement DOD took in response to the incident at Dugway Proving Ground was to improve quality control and assurance at Dugway and other DOD facilities that currently handle BSAT. The Army’s 2015 investigation report made several recommendations to the Army to enhance and improve quality control and assurance at Dugway Proving Ground. These included (1) establishing a quality control and assurance manager, (2) carrying out an environmental sampling and inspection program, and (3) developing and enhancing the video surveillance program. BSAT Biorisk Program Office (BBPO) officials explained that the DOD BSAT laboratories had some quality control and assurance measures in place prior to the National Defense Authorization Act (NDAA) for Fiscal Year 2017.

The quality control and assurance recommendations from the Army’s 2015 investigation report, which initially applied only to Dugway Proving Ground, were subsequently enacted in section 218 of the NDAA for Fiscal Year 2017 to apply to all DOD covered facilities. These requirements include: 1. designation of an external manager to oversee quality assurance and 2. environmental sampling and inspections; 3. production procedures that prohibit operations where live BSAT are used in the same laboratory where viability testing is conducted; 4. production procedures that prohibit work on multiple organisms or multiple strains of one organism within the same biosafety cabinet; 5. a video surveillance program that uses video monitoring as a tool to improve laboratory practices in accordance with regulatory requirements; 6. formal, recurring data reviews of production in an effort to identify trends and nonconformance issues before such issues affect end products; 7. validated protocols for production processes to ensure that process deviations are adequately vetted prior to implementation; and 8. maintenance and calibration procedures and schedules for all tools, equipment, and irradiators.

BBPO officials told us that, in response to the requirements in the NDAA for Fiscal Year 2017, they are developing a department-wide quality control and assurance program for the BSAT community. BBPO also developed several policies that address the measures mandated by the NDAA for Fiscal Year 2017. These policies address setting minimum requirements for (1) monitoring environmental quality, (2) performing maintenance on laboratory equipment, and (3) controlling laboratory cross-contamination between organisms or strains within the same biological safety cabinet and between live and inactivated BSAT.

DOD officials said that some NDAA for Fiscal Year 2017 requirements do not necessarily apply to every laboratory. According to DOD officials, some of these requirements are no longer relevant as a result of certain events, such as the inadvertent shipment of incompletely inactivated anthrax from the BioTesting Division at Dugway Proving Ground that currently is not handling BSAT. Furthermore, some of the requirements need further clarification. For example, the NDAA for Fiscal Year 2017 required DOD covered facilities to implement quality control and quality assurance measures, including a video surveillance program that uses video monitoring, in accordance with regulatory requirements. (In providing technical comments on a draft of this report, both the Department of Health and Human Services’ Centers for Disease Control and Prevention and Department of Agriculture’s Animal and Plant Health Inspection Service—which jointly manage the Federal Select Agent Program—said that select agent regulations do not require development and utilization of a video surveillance program.)

The Army’s 2015 investigation report also recommended the development and utilization of a video surveillance program in accordance with Federal Select Agent Program regulatory requirements. DOD officials stated that there is no such requirement in federal select agent regulations and, therefore, to implement a video surveillance program would result in laboratories having an unfunded requirement for maintenance costs. According to a BBPO official, DOD officials reached out to congressional staff to obtain clarification on implementing this requirement and, according to these officials, were advised to “interpret the requirement as appropriate.” DOD officials stated that because the federal select agent regulations do not require video surveillance, DOD is not obligated to implement a video surveillance program in accordance with the provision in the NDAA for Fiscal Year 2017. Army Regulation 190-17 for the BSAT security program, however, already includes a requirement that all Army Biosafety Level-3 and 4 laboratories have operational closed-circuit television cameras installed and positioned so that all areas of the research room can be viewed. In response to the NDAA for Fiscal Year 2017 and its requirement to implement a video surveillance program, BBPO officials stated that recommendations for the use of video surveillance are being established by the Quality Assurance Working Group that supports BBPO for all laboratories in each of the military services that handle BSAT.

DOD is Developing a New Quality Management System

Example of a Potential Quality Control and Assurance Procedure at the Department of Defense (DOD) DOD’s future quality management system will include critical control points for helping to prevent personnel from making mistakes while conducting scientific procedures. For example, a certain procedure for extracting genetic information from pathogens that also inactivates pathogens uses a chemical mixture called TRIzol. The quality management system will include a critical control point for this procedure in the form of achieving a ratio of pathogen sample to the amount of TRIzol. In this new system, the scientist or laboratory technician may be required to enter the amount into the new system to show that the ratio is correct to inactivate the pathogen.

DOD officials report that, to enhance quality control and assurance at Dugway Proving Ground and across DOD’s currently covered facilities, the Joint Program Executive Office for Chemical and Biological Defense, on behalf of BBPO, is in the process of developing a new quality management system known as the Joint Interagency Biorisk System. The system would centralize information on DOD’s BSAT Biosafety and Biosecurity Program, such as operational and governance documentation. For example, the system would gather applicable quality assurance-related information from Dugway Proving Ground and DOD’s currently covered facilities to provide BBPO with the ability to track inventory and shipment of BSAT materials and ensure that approvals and waivers for exceptions to laboratory protocols are made at the appropriate level, among other things. DOD currently is identifying the critical control points that would be built into the Joint Interagency Biosafety System to ensure quality throughout the BSAT handling, production, storage, containment, shipment, destruction, and inactivation processes. According to officials from BBPO, DOD’s future quality management system will include critical control points to help personnel prevent mistakes while conducting scientific procedures (see sidebar for additional information).

DOD Has Conducted Studies on Inactivating Pathogens and Is Continuing Its Research

In response to the results of DOD’s July 2015 30-day review, the Deputy Secretary of Defense directed the Under Secretary of Defense for Acquisition, Technology and Logistics to develop a plan for research related to the development of standardized irradiation and viability testing protocols. The Army’s subsequent 2015 investigation report also identified specific actions the Secretary of the Army should consider taking, including directing additional research to address existing gaps in scientific knowledge regarding the inactivation of BSAT.

Chemical and Biological Defense Program officials said that they are developing a validated method for inactivating Bacillus anthracis spores using irradiation to improve safety. DOD reported completion of the first phase of the study for developing a validated method with scientists from three DOD laboratories, using a weakened strain of Bacillus anthracis. The second phase of the Bacillus anthracis inactivation study was completed in October 2017, according to Army officials, using a potentially lethal strain of Bacillus anthracis. In April 2018, DOD officials stated that as a result of the first two phases of this study, they have received approval from peer reviewers to publish their study results, which will recommend these results as a validated inactivation method. The next step will be to analyze the data from these studies to determine whether additional studies are needed to answer further questions about factors that may affect testing for the presence of live pathogens.

The Army Has Taken Multiple Types of Actions at Dugway Proving Ground to Implement Recommendations from the Army’s 2015 Investigation Report

Since 2015, the Army also has taken multiple types of actions specifically at Dugway Proving Ground—including operational, administrative, and personnel actions—to implement the recommendations from the Army’s 2015 investigation report. The report made several recommendations for improvements at the BioTesting Division at Dugway Proving Ground. The Army’s subsequent Directive 2016-24 assigned responsibility for implementing some of these recommendations and called for additional actions, including reassigning command and control of the division to the Army’s Edgewood Chemical Biological Center at Aberdeen Proving Ground, Maryland. According to DOD officials, as part of this action, a new management team was established at the BioTesting Division that includes new managers responsible for quality control and assurance. In addition to hiring personnel, the BioTesting Division established training programs for all laboratory staff, including training sessions on biological safety, for which participants received certification after completing coursework.

In response to the 2015 incident at Dugway Proving Ground, the Centers for Disease Control and Prevention suspended Dugway Proving Ground’s BioTesting Division’s certificate of registration in accordance with federal select agent regulations in August 2015. In May 2017, DOD’s request for withdrawal of the laboratory’s registration was approved and remaining BSAT in its possession was either transferred or destroyed. DOD officials explained that the withdrawal of the BioTesting Division’s registration has allowed the division time to implement recommendations, modernize and make repairs to laboratories, and retrain personnel without the added burden of continuous inspections. Officials from the BioTesting Division stated that they are in the process of re-registering with the Federal Select Agent Program and are taking a phased approach in anticipation of reaching full operational status in fiscal year 2019. Figure 11 is a timeline of selected actions DOD has taken.

Because BBPO is focused on broader issues and not just the Army’s 2015 investigation report recommendations, BBPO officials have also compiled and consolidated recommendations and actions from multiple reports, including the Army’s 2015 investigation report, the DOD Review Committee Report, a DOD Inspector General report, and the NDAA for Fiscal Year 2017. BBPO officials explained that they developed tasks to operationalize the recommendations and acknowledged that BBPO and the now-terminated General Officers Steering Committee had not yet developed a standardized definition for recommendations deemed complete. BBPO officials told us they consider all of these recommendations to be part of their broader DOD biosafety efforts.

Appendix VI: Key Themes and Selected Comments from Staff at Department of Defense BSAT Facilities

As part of our review, we conducted facilitated discussions between September 2017 and November 2017 using a self-selected sample of supervisory and non-supervisory staff at six Department of Defense (DOD) laboratories, five of which currently handle biological select agents and toxins (BSAT). The purpose of the discussions was to better understand the effects of DOD actions on laboratory staff and operations following the 2015 discovery that staff at Dugway Proving Ground had incompletely inactivated Bacillus anthracis and subsequently shipped live anthrax to multiple locations. The intent was to obtain the views of those laboratory staff who have and will be implementing recommendations from multiple reports. Using a protocol we developed, one of our analysts facilitated each discussion group by asking a similar set of questions about effects of the DOD response to the 2015 incident at Dugway Proving Ground. Our analysts documented laboratory staffs’ comments as closely as possible to the original language used by participants. During subsequent reviews and sorting (coding) of the participants comments, we found that four key themes emerged. Within each of the four themes, our analysts also identified related sub-themes.

For the purposes of selecting individual comments as shown in table 3 below, our analysts considered several factors including clarity and relevance to our study’s objectives. Our self-selected convenience sample of laboratory staff provided comments describing the various effects of the 2015 anthrax incident on laboratory staff and operations. We did not verify the factual basis of the laboratory staff comments. Moreover, the comments that we have identified cannot be generalized to all DOD laboratory staff at the six facilities we visited. Table 3 lists the key theme, sub-theme, and selected comments made by laboratory staff during our facilitated discussion groups at each of the six DOD covered laboratories, five of which currently handle BSAT.

Appendix VII: Department of Defense Reported Responses to Tasks Required by the NDAA for Fiscal Year 2017

The Department of Defense (DOD) issued a report to the defense congressional committees on April 10, 2017, in response to section 218 of the National Defense Authorization Act (NDAA) for Fiscal Year 2017. As of March 2018, DOD officials stated that the tasks required by the NDAA for Fiscal Year 2017 to study the consolidation of commands, opportunities to partner with industry for the production of biological select agents and toxins (BSAT), and the transfer of BSAT production responsibilities are still ongoing. Table 4 shows the status of DOD’s efforts to respond to the tasks required by the NDAA for Fiscal Year 2017.

Appendix VIII: Summary of Selected Federal Panels, Task Forces, and Working Groups Examining Biodefense-Related Issues

Biosafety, biosecurity, and biodefense issues have been a long-standing concern for the nation. The federal government has been examining biosafety, biosecurity, and biodefense issues for over a decade through many voluntary and federally mandated commissions, task forces, and federal panels and working groups. These issues have been reviewed from a variety of perspectives—scientific, regulatory, academic, health, national defense, and homeland security. Table 5 provides a summary of some key recommendations and observations to address biosafety, biosecurity, and biodefense issues and related topics. The Department of Defense (DOD) participated in many of these efforts, some of which are ongoing, including the National Science Advisory Board for Biosecurity and the Federal Experts Security Advisory Panel. Observations represent comments made by individual participants and do not represent organizational recommendations.

Appendix IX: Comments from the Department of Defense

Appendix X: GAO Contact and GAO Acknowledgments

GAO Contact

Staff Acknowledgments

In addition to the contact name above, GAO staff who made key contributions on this report include Mark A. Pross (Assistant Director); Latrealle Lee (Analyst-in-Charge); Amy Bowser; Patricia Farrell Donahue, Ph.D.; Alexandra Gonzalez; Ashley Grant, Ph.D.; Matthew Jacobs; Joanne Landesman; Amie Lesser; Amber Lopez Roberts; Timothy M. Persons, Ph.D.; Bethann Ritter Snyder, and Lillian Yob.

Glossary

assay: A quantitative or qualitative procedure for detecting the presence, estimating the concentration, and/or determining the biological activity of a macromolecule (e.g., an antibody or antigen, molecule, ion, cell, pathogen, etc.). Assays are based on measurable parameters that allow differentiation between sample and control. biodefense: Prevention, protection against, and mitigations for biological threats that could have catastrophic consequences to the nation. biological agent: Microorganism (or derived toxin) that causes disease in humans, animals, or plants. biological weapon: A harmful biological agent used as a weapon to cause death or disease usually on a large scale. biorisk management: The effective management of risks posed by working with infectious agents and toxins in laboratories; it includes a range of practices and procedures to ensure the biosecurity, biosafety, and biocontainment of those infectious agents and toxins. biosafety: The combination of practices, procedures, and equipment that protect laboratory workers, the public, and the environment from the infectious agents and toxins used in the laboratory. biosecurity: The measures taken to protect infectious agents and toxins from loss, theft, or misuse. biotechnology: The manipulation of living organisms or their components to produce useful usually commercial products. biological select agents and toxins certified personnel: Personnel certified and cleared to work with biological select agents and toxins. covered facility: Any facility of the Department of Defense that produces biological select agents and toxins. decontamination: The removal or count reduction of contaminating pathogens present on an object.

Federal Select Agent Program: A regulatory program established to regulate the possession, use, and transfer of biological select agents and toxins. high-containment laboratory: Biosafety level (BSL)-3 or 4 facilities in which studies are conducted on a variety of dangerous pathogens and toxins. inactivation: A procedure to render pathogens as non-toxic while retaining characteristics of interest for future use. irradiation: A process by which radiation (e.g., ultraviolet light, gamma rays, and X-rays) is used. nonviable: A pathogen that is no longer capable of growing, replicating, infecting, or causing disease. protocol: A detailed plan for a scientific procedure. select agent: A biological agent or toxin that (1) potentially poses a severe threat to public health and safety, animal or plant health, or animal or plant products and (2) is regulated by select agent rules for possession, use, and transfer (7 C.F.R. Part 331 (2018), 9 C.F.R. Part 121 (2018), and 42 C.F.R. Part 73 (2018)). toxin: The toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, or protozoa), or infectious substances, or a recombinant or synthesized molecule, whatever their origin and method of production, and includes (1) any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism or (2) any poisonous isomer or biological product, homolog, or derivative of such a substance. ultracentrifuge: A high-speed centrifuge able to separate colloidal and other small particles and used especially in determining the sizes of such particles or the molecular weights of large molecules. validation: For the purpose of inactivation methods, the method must be scientifically sound and produce consistent results each time it is used such that the expected result can be ensured. Methods of validation may include (1) use of the exact conditions of a commonly accepted method that has been validated, (2) a published method with adherence to the exact published conditions, or (3) for in-house methods, validation testing should include the specific conditions used and appropriate controls (from the Federal Select Agent Program). validated inactivation procedure: A procedure to render a select agent non-viable but which allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use. The efficacy of the procedure is confirmed by demonstrating the material is free of all viable select agents.

Related GAO Products

DOD Personnel: Further Actions Needed to Strengthen Oversight and Coordination of Defense Laboratories’ Hiring Efforts. GAO-18-417. Washington, D.C.: May 30, 2018.

High-Containment Laboratories: Coordinated Efforts Needed to Further Strengthen Oversight of Select Agents. GAO-18-197T. Washington, D.C.: November 2, 2017.

High-Containment Laboratories: Coordinated Actions Needed to Enhance the Select Agent Program’s Oversight of Hazardous Pathogens. GAO-18-145. Washington, D.C.: October 19, 2017.

Biodefense: Federal Efforts to Develop Biological Threat Awareness. GAO-18-155. Washington, D.C.: October 11, 2017.

Public Health Information Technology: HHS Has Made Little Progress toward Implementing Enhanced Situational Awareness Network Capabilities. GAO-17-377. Washington, D.C.: September 6, 2017.

High-Containment Laboratories: Actions Needed to Mitigate Risk of Potential Exposure and Release of Dangerous Pathogens. GAO-16-871T. Washington, D.C.: September 23, 2016.

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High-Containment Laboratories: Comprehensive and Up-to-Date Policies and Stronger Oversight Mechanisms Needed to Improve Safety. GAO-16-305. Washington, D.C.: March 21, 2016.

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Chemical and Biological Defense: Designated Entity Needed to Identify, Align, and Manage DOD’s Infrastructure. GAO-15-257. Washington, D.C.: June 25, 2015.

Standards for Internal Control in the Federal Government. GAO-14-704G. Washington, D.C.: September 2014.

High-Containment Laboratories: Recent Incidents of Biosafety Lapses. GAO-14-785T. Washington, D.C.: July 16, 2014.

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Homeland Security: Agriculture Inspection Program Has Made Some Improvements, but Management Challenges Persist. GAO-12-885. Washington, D.C.: September 27, 2012.

Environmental Justice: EPA Needs to Take Additional Actions to Help Ensure Effective Implementation. GAO-12-77. Washington, D.C.: October 6, 2011.

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