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


Highlights: section_title: Why GAO Did This Study
paragraphs: In May 2015, DOD discovered that one of its laboratories (formerly called the Life Sciences Division) at Dugway Proving Ground, Utah, had inadvertently made 575 shipments of live Bacillus anthracis —the bacterium that causes anthrax—to 194 laboratories and contractors worldwide from 2004 through 2015. A December 2015 investigation by the Army determined that there was insufficient evidence to establish a single point of failure and made recommendations for improving safety and security at DOD laboratories that handle BSAT.

The NDAA for Fiscal Year 2017 included a provision for GAO to review DOD's actions to address the Army's recommendations. GAO assessed the extent to which (1) DOD has implemented recommendations from the Army's 2015 investigation report, (2) the Army has implemented the BSAT Biosafety and Biosecurity Program and developed a strategy and implementation plan, (3) the Army's biological T&E mission is independent from its biological R&D mission, and (4) DOD has carried out a required study and evaluation. GAO reviewed DOD documents and key actions in response to the Army's recommendations and conducted site visits to DOD's BSAT laboratories.

section_title: What GAO Found
paragraphs: The Department of Defense (DOD) has made progress by taking a number of actions to address the 35 recommendations from the Army's 2015 investigation report on the inadvertent shipments of live Bacillus anthracis (anthrax). However, DOD has not yet developed an approach to measure the effectiveness of these actions. As of March 2018, DOD reports 18 recommendations as having been implemented and 17 as having actions under way to implement them. These actions are part of a broader effort to improve biosafety, biosecurity, and overall program management. For example, in March 2016, DOD established the Biological Select Agents and Toxins (BSAT) Biorisk Program Office to assist in overseeing the BSAT Biosafety and Biosecurity Program and implementation of the recommendations. Measuring the effectiveness of each implemented recommendation would help better determine if the actions taken are working, if there are unintended consequences, or if further action is necessary.

The Secretary of the Army, as DOD's Executive Agent, has implemented a BSAT Biosafety and Biosecurity Program to improve management, coordination, safety, and quality assurance for the DOD BSAT enterprise. However, DOD has not developed a strategy and implementation plan for managing the program. Without a strategy and implementation plan, Dugway Proving Ground, Utah, and DOD's laboratory facilities that currently produce and handle BSAT may be unclear about DOD's strategy to harmonize BSAT operations to ensure safety, security, and standardization of procedures throughout DOD's BSAT enterprise.

The Army has not fully institutionalized measures to ensure that its biological test and evaluation (T&E) mission remains independent from its biological research and development (R&D) mission so that its T&E procedures are objective and reliable. In April 2016, the Army directed the transfer of the operational T&E mission from West Desert Test Center-Life Sciences Division at Dugway Proving Ground, Utah, to Edgewood Chemical Biological Center, Maryland. The Army issued a memorandum of agreement between the two entities to lay out roles and responsibilities for test processes and procedures. However, the memorandum does not distinguish T&E from R&D mission requirements, and does not contain guidelines to mitigate risks associated with potential conflicts of interest between the R&D and T&E missions. Without these measures, there is a potential risk to the independence of the T&E mission.

The National Defense Authorization Act (NDAA) for Fiscal Year 2017 required DOD to report by February 1, 2017, on the feasibility of consolidating BSAT facilities within a unified command, partnering with industry for the production of BSAT in lieu of maintaining such capabilities within the Army, and whether such operations should be transferred to another government or commercial laboratory. DOD has not completed this required study and evaluation of its BSAT infrastructure which, when complete, will affect the future infrastructure of the BSAT Biosafety and Biosecurity Program. Further, DOD officials have no estimated time frames for when DOD will complete the study and evaluation. Without time frames for completing the study and evaluation, DOD is unable to provide decision makers with key information on its infrastructure requirements.

section_title: What GAO Recommends
paragraphs: GAO recommends that DOD develop an approach to assess the effectiveness of the recommendations, a strategy and implementation plan for its BSAT Biosafety and Biosecurity Program, measures to ensure independence, and time frames to complete a study. DOD concurred with all four of GAO's recommendations.

section_title: Letter
paragraphs: Safety lapses involving hazardous pathogens have occurred at some of  the 276 government, private, and academic laboratories in the United  States that conduct research on biological select agents and toxins  (BSAT). Such agents may cause serious or lethal infection in humans,  animals, or plants. BSAT materials, such as the Ebola virus and Bacillus  anthracis—the bacterium that causes anthrax—have been determined to  have the potential to pose a severe threat to public health and safety.  Laboratories conduct research on BSAT for a variety of reasons,  including identifying their characteristics and developing vaccines and  other measures to help diagnose, prevent, or treat exposure to or  infection by these agents. Safety lapses involving hazardous pathogens  have occurred in the past at some of the Department of Defense (DOD)  laboratories that handle BSAT to conduct research on medical and  physical countermeasures to protect the warfighter from biological  threats. Such incidents raise concerns about whether oversight of  biosafety and biosecurity in these laboratories is effective.

In May 2015, DOD discovered that one of its laboratories—formerly called  the Life Sciences Division—at Dugway Proving Ground, Utah, had  inadvertently shipped incompletely inactivated (i.e., live) Bacillus  anthracis to 194 laboratories and contractors worldwide over the course  of 12 years. In response to this discovery, the Deputy Secretary of  Defense ordered an immediate 30-day review in May 2015 that resulted  in a moratorium on the production, handling, testing, and shipment of  inactivated Bacillus anthracis. The Deputy Secretary of Defense  subsequently directed a more detailed review by the Army. In December  2015, the Army issued an investigation report on its findings which,  among other things, determined that although the inadvertent shipment of  incompletely inactivated Bacillus anthracis was a serious breach of  regulations and raised biosecurity concerns, it did not pose a public  health risk. The investigation also determined that there was insufficient  evidence to establish a single failure as the cause for the inadvertent  shipments of incompletely inactivated Bacillus anthracis. However, the  report cited scientific and institutional issues and said that senior  management at Dugway Proving Ground had contributed to “a culture of  complacency, resulting in laboratory personnel not always following rules,  regulations, and procedures.” The Army’s 2015 investigation report  resulted in recommendations to the Army to improve scientific knowledge  gaps on irradiation and viability testing processes, address institutional  concerns to reduce the risk of future mishaps involving biological material,  and address individual accountability for the failures that contributed to  the inadvertent shipment of incompletely inactivated Bacillus anthracis.

DOD’s Chemical and Biological Defense Program (CBDP) leads the  department’s efforts to protect military personnel, particularly the  warfighter, against a wide range of threats, including biological threats.  The CBDP Enterprise is comprised of 26 DOD organizations that  determine warfighter requirements, provide science and technology  expertise, conduct research and development and test and evaluation on  capabilities needed to protect the warfighter, and provide oversight. In  fiscal year 2017, according to DOD officials, CBDP received about   $1.2 billion to support research, development, testing, and evaluation,  and procurement efforts. For fiscal year 2018, CBDP received nearly   $1.4 billion. The Army supports CBDP, and the Secretary of the Army is  the Executive Agent for the BSAT Biosafety and Biosecurity Program.

Since 2007, we have testified and reported on issues associated with  high-containment laboratories that handle BSAT and have recommended  improvements for federal oversight and enhancements to biosafety and  biosecurity. Our most recent testimonies and reports have addressed the  effectiveness of the current federal approach to overseeing select agents  and issues related to the inactivation of pathogens in high-containment  laboratories. For example, in our July 2015 testimony before the House  Energy and Commerce Subcommittee on Oversight and Investigations,  we noted that DOD had begun to track biosafety and biosecurity incidents  at the senior department level, which it had not done prior to the May  2015 incident at Dugway Proving Ground in which incompletely  inactivated Bacillus anthracis was inadvertently shipped to other  laboratories and contractors worldwide.

In March 2016, we issued a report that made recommendations to various  federal departments and agencies with responsibility for managing BSAT  in high-containment laboratories. Some of these recommendations were  addressed to DOD. The department concurred with the recommendations on improving oversight mechanisms of high- containment laboratories. In implementing those recommendations, DOD  reported in 2016 that it was taking actions, such as revising existing  department policies for managing hazardous biological agents in high- containment laboratories; analyzing inspection trends and incident reports  to identify recurring issues in safety, security, or administration; requiring  routine reporting results from laboratories that are not registered to  handle select agents and laboratory incidents; and developing  implementation time frames for the recommendations from a July 2015  DOD review of the incident at Dugway Proving Ground.

Section 218 of the National Defense Authorization Act (NDAA) for Fiscal  Year 2017 included a provision for us to review DOD’s actions to address  findings and recommendations of the Army’s December 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 review DOD’s efforts to implement quality  control and assurance measures for the department’s 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 from its biological  research and development mission, and (4) DOD has carried out a study  and evaluation in compliance with the requirements of section 218,  subsection (d), of the NDAA for Fiscal Year 2017.

For objective one, we reviewed key policy, guidance, and other  documents, including the recommendations from the Army’s 2015  investigation report, and assessed the actions that DOD took from May  2015 through May 2018 to address those recommendations. In addition,  we reviewed the 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.

For objective two, we obtained and reviewed 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. We compared the actions of the Army  to leading practices for strategic planning and the recommendations from  the Army’s 2015 investigation report. We interviewed DOD officials from  the military services to identify 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 identify  any biosafety and biosecurity improvements that have been made to  DOD laboratories that possess, use, or transfer biological select agents  and toxins made since the 2015 incident at Dugway Proving Ground. In  addition, we conducted site visits to all six DOD BSAT laboratories, five of  which currently are responsible for handling BSAT. We also conducted  voluntary facilitated group discussions with small, self-selected groups of  laboratory staff at each of these facilities to obtain their views on the  effect of the incident at Dugway Proving Ground on covered facilities and  on DOD’s subsequent corrective actions.

For objective three, we reviewed and compared an Army regulation on  test and evaluation to an Army general order that directed the  reassignment of the West Desert Test Center – Life Sciences Division at  Dugway Proving Ground, Utah, to the U.S. Army Materiel Command  Research, Development and Engineering Command – U.S. Army  Edgewood Chemical Biological Center at Aberdeen Proving Ground,  Maryland. We also compared that Army regulation to an Army directive  that provided guidelines for the transfer of the Life Sciences Division (now  known as the BioTesting Division) from Army Test and Evaluation  Command to Army Research, Development and Engineering Command’s  Edgewood Chemical Biological Center. We conducted interviews with  senior staff at the BioTesting Division, the West Desert Test Center, and  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 Edgewood Chemical Biological  Center’s research and development efforts.

For objective four, we compared the relevant requirements from the  NDAA for Fiscal Year 2017 contained in section 218, subsection (d), with  DOD’s April 2017 report to the congressional defense committees, to  determine whether the report included all of the required elements.  Specifically, DOD is required to evaluate (1) the feasibility of consolidating  covered facilities within a unified command to minimize risk,   (2) opportunities to partner with industry on the production of BSAT and  related services in lieu of maintaining such capabilities within the Army,  and (3) whether BSAT operations should be transferred to another  laboratory that may be better suited to execute production for non-DOD  customers. We also reviewed our prior reports that evaluated federal  oversight of high-containment laboratories and DOD’s management of  infrastructure within the CBDP Enterprise, and we toured all six DOD  BSAT laboratory facilities to observe the current physical space—both  operational and under construction—for handling and testing BSAT. More  detailed information on our scope and methodology can be found in  appendix I of this report.

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.
subsections: section_title: Background
subsections: section_title: Biodefense Roles and Responsibilities
paragraphs: 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.

section_title: The Federal Select Agent Program
paragraphs: 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.

section_title: DOD’s Designated Infrastructure Manager for CBDP, Including BSAT
paragraphs: 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.

section_title: BSAT Policies and Guidance
paragraphs: 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.

section_title: The Army’s Investigation into the May 2015 Dugway Incident
paragraphs: 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.

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

section_title: The Army Has Implemented a BSAT Biosafety and Biosecurity Program but Does Not Have a Completed Strategy and Implementation Plan
subsections: section_title: The BSAT Biosafety and Biosecurity Program Is a Broad Effort to Improve Management, Coordination, Safety, and Quality Assurance
paragraphs: 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.

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

section_title: The Army Has Not Fully Institutionalized Measures to Ensure the Independence of Edgewood Chemical Biological Center’s Test and Evaluation Mission
paragraphs: 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.

section_title: 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
paragraphs: 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.

section_title: Conclusions
paragraphs: 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.

section_title: Recommendations for Executive Action
paragraphs: 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)

section_title: Agency Comments and Our Evaluation
paragraphs: 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.

section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: 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.
subsections: section_title: Department of Defense

section_title: Department of Agriculture

section_title: Department of Health and Human Services
paragraphs: 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.

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

section_title: Appendix III: Actions Taken to Implement Recommendations from the Army’s 2015 Investigation Report as of March 2018
paragraphs: 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.

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

section_title: Appendix V: The Department of Defense Has Made Key Safety Improvements by Implementing Recommendations
paragraphs: 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.
subsections: section_title: DOD Has Established an Executive Agent for DOD’s BSAT Biosafety and Biosecurity Program
paragraphs: 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.

section_title: DOD Has Improved Quality Control and Assurance at Dugway Proving Ground and Currently Covered Facilities
paragraphs: 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.

section_title: DOD is Developing a New Quality Management System
paragraphs: 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).

section_title: DOD Has Conducted Studies on Inactivating Pathogens and Is Continuing Its Research
paragraphs: 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.

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

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

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

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

section_title: Appendix IX: Comments from the Department of Defense

section_title: Appendix X: GAO Contact and GAO Acknowledgments
subsections: section_title: GAO Contact

section_title: Staff Acknowledgments
paragraphs: 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.

section_title: Glossary
paragraphs: 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.

section_title: Related GAO Products
paragraphs: 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.

High-Containment Laboratories: Improved Oversight of Dangerous  Pathogens Needed to Mitigate Risk. GAO-16-642. Washington, D.C.:  August 30, 2016.

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.

High-Containment Laboratories: Preliminary Observations on Federal  Efforts to Address Weaknesses Exposed by Recent Safety Lapses.  GAO-15-792T. Washington, D.C.: July 28, 2015.

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.

High-Containment Laboratories: Assessment of the Nation’s Need Is  Missing. GAO-13-466R. Washington, D.C: February 25, 2013.

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.

High-Containment Biosafety Laboratories: Preliminary Observations on  the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the  United States. GAO-08-108T. Washington, D.C.: October 4, 2007.

Test and Evaluation: Impact of DOD’s Office of the Director of  Operational Test and Evaluation. GAO/NSIAD-98-22. Washington, D.C.:  October 24, 1997.


Question-summary annotations: questions: question: How did DOD address the 35 recommendations from the Army's 2015 investigation report on the inadvertent shipments of live Bacillus anthracis (anthrax)?
answer: The Department of Defense (DOD) has made progress by taking a number of actions to address the 35 recommendations from the Army's 2015 investigation report on the inadvertent shipments of live Bacillus anthracis (anthrax).
child_questions: question: What has DOD not done in relation to these actions?
answer: However, DOD has not yet developed an approach to measure the effectiveness of these actions.
child_questions: question: What is the benefit of measuring the effectiveness of these actions?
answer: Measuring the effectiveness of each implemented recommendation would help better determine if the actions taken are working, if there are unintended consequences, or if further action is necessary.

question: What is the goal of the actions taken by DOD?
answer: These actions are part of a broader effort to improve biosafety, biosecurity, and overall program management.
child_questions: question: What action did DOD take for implementation of the recommendations in March 2016?
answer: For example, in March 2016, DOD established the Biological Select Agents and Toxins (BSAT) Biorisk Program Office to assist in overseeing the BSAT Biosafety and Biosecurity Program and implementation of the recommendations.

questions: question: Why has the Secretary of the Army implemented a BSAT Biosafety and Biosecurity Program?
answer: The Secretary of the Army, as DOD's Executive Agent, has implemented a BSAT Biosafety and Biosecurity Program to improve management, coordination, safety, and quality assurance for the DOD BSAT enterprise.
child_questions: question: What is the problem for the BSAT Biosafety and Biosecurity Program?
answer: However, DOD has not developed a strategy and implementation plan for managing the program.
child_questions: question: What is the consequence of the lack of a strategy and implementation plan?
answer: Without a strategy and implementation plan, Dugway Proving Ground, Utah, and DOD's laboratory facilities that currently produce and handle BSAT may be unclear about DOD's strategy to harmonize BSAT operations to ensure safety, security, and standardization of procedures throughout DOD's BSAT enterprise.

questions: question: Why should the Army ensure that its biological test and evaluation (T&E) mission remains independent from its biological research and development (R&D) mission?
answer: The Army has not fully institutionalized measures to ensure that its biological test and evaluation (T&E) mission remains independent from its biological research and development (R&D) mission so that its T&E procedures are objective and reliable.

question: How has the Army attempted to transfer the operational T&E mission In April 2016?
answer: In April 2016, the Army directed the transfer of the operational T&E mission from West Desert Test Center-Life Sciences Division at Dugway Proving Ground, Utah, to Edgewood Chemical Biological Center, Maryland. The Army issued a memorandum of agreement between the two entities to lay out roles and responsibilities for test processes and procedures.
child_questions: question: What were the problems with the memorandum issued by the Army?
answer: However, the memorandum does not distinguish T&E from R&D mission requirements, and does not contain guidelines to mitigate risks associated with potential conflicts of interest between the R&D and T&E missions.
child_questions: question: What could happen if the problems are not resolved?
answer: Without these measures, there is a potential risk to the independence of the T&E mission.

questions: question: What did the National Defense Authorization Act (NDAA) for Fiscal Year 2017 require DOD to report by February 1, 2017?
answer: The National Defense Authorization Act (NDAA) for Fiscal Year 2017 required DOD to report by February 1, 2017, on the feasibility of consolidating BSAT facilities within a unified command, partnering with industry for the production of BSAT in lieu of maintaining such capabilities within the Army, and whether such operations should be transferred to another government or commercial laboratory.
child_questions: question: What is DOD's progress in the required study and evaluation of its BSAT infrastructure?
answer: DOD has not completed this required study and evaluation of its BSAT infrastructure which, when complete, will affect the future infrastructure of the BSAT Biosafety and Biosecurity Program.

question: What are the estimated time frames for DOD to complete the study and evaluation?
answer: Further, DOD officials have no estimated time frames for when DOD will complete the study and evaluation.
child_questions: question: How would the lack of time frames for completing the study and evaluation affect BSAT infrastructure ?
answer: Without time frames for completing the study and evaluation, DOD is unable to provide decision makers with key information on its infrastructure requirements.

questions: question: What actions of the DOD's actions did GAO review with the provision included in the NDAA for Fiscal Year 2017?
answer: The NDAA for Fiscal Year 2017 included a provision for GAO to review DOD's actions to address the Army's recommendations.
child_questions: question: How did GAO review DOD's actions to address the Army's recommendations?
answer: GAO assessed the extent to which (1) DOD has implemented recommendations from the Army's 2015 investigation report, (2) the Army has implemented the BSAT Biosafety and Biosecurity Program and developed a strategy and implementation plan, (3) the Army's biological T&E mission is independent from its biological R&D mission, and (4) DOD has carried out a required study and evaluation. GAO reviewed DOD documents and key actions in response to the Army's recommendations and conducted site visits to DOD's BSAT laboratories.

question: What specific actions did GAO take to review DOD's actions to address the Army's recommendations?
answer: GAO reviewed DOD documents and key actions in response to the Army's recommendations and conducted site visits to DOD's BSAT laboratories.