The Implementing Recommendations of the 9/11 Commission Act of  2007 (9/11 Commission Act) established the National Biosurveillance  Integration Center (NBIC) within DHS. NBIC was specifically tasked with  integrating and analyzing information from human health, animal, plant,  food, and environmental monitoring systems across the federal  government and supporting the interagency biosurveillance community. Senior NBIC officials agreed that  these three roles—analyzer, coordinator, and innovator—are consistent  with the center’s responsibilities. To contribute to this  national capability, in 2003, DHS created the BioWatch program to  provide early warning, detection, or recognition of a biological attack. DHS Has Faced Challenges, Some Persistent, In Its Efforts to Carry Out Biosurveillance Programs

		NBIC Has Faced Difficulty Demonstrating Value to Interagency Partners

In December 2009, we reported that NBIC was not fully equipped to carry  out its mission because it lacked key resources—data and personnel— from its partner agencies, which may have been at least partially the  result of collaboration challenges it faced. For example, some partners  reported that they did not trust NBIC to use their information and  resources appropriately, while others were not convinced of the value that  working with NBIC provided because NBIC’s mission was not clearly  articulated. In order to help NBIC enhance and sustain collaboration, including the  provision of data, personnel, and other resources, in 2009, we  recommended that NBIC develop a strategy for addressing barriers to  collaboration and develop accountability mechanisms to monitor these  efforts. In August 2012, NBIC issued the NBIC Strategic Plan, which is  intended to provide NBIC’s strategic vision, clarify the center’s mission  and purpose, articulate the value that NBIC seeks to provide to its  partners, and lay the groundwork for setting interagency roles,  responsibilities, and procedures. Although NBIC had made efforts to collaborate with interagency partners  to create and issue a strategic plan that would clarify its mission and the  various efforts to fulfill its three roles, we reported a variety of challenges  that remained when we surveyed NBIC’s interagency partners for our  2015 report. Notably, many of these partners continued to express  uncertainty about the value NBIC provided. We also reported in September 2015 that NBIC faces challenges  prioritizing developmental efforts to identify and address needs for new  biosurveillance tools. We identified options  in our 2015 report for policy or structural changes that could help better  fulfill the biosurveillance integration mission, which are summarized  below. BioWatch’s Ability to Detect Attacks Uncertain Because It Lacks Performance Requirements that Correspond to a Clearly Defined Mission

Since 2003, DHS has focused on acquiring an autonomous detection  system to replace the current BioWatch Gen-2, but has faced challenges  in clearly justifying the BioWatch program’s need and ability to reliably  address that need. In September 2012, we found that DHS approved the  Gen-3 acquisition in October 2009 without fully developing critical  knowledge that would help ensure sound investment decision making,  pursuit of optimal solutions, and reliable performance, cost, and schedule  information. To help ensure DHS based its acquisition decisions on reliable  performance, cost, and schedule information developed in accordance  with guidance and good practices, in our September 2012 report, we  recommended that before continuing the Gen-3 acquisition, DHS  reevaluate the mission need and possible alternatives based on cost- benefit and risk information. In April 2014, DHS canceled the acquisition of Gen-3 because the  AoA did not confirm an overwhelming benefit to justify the cost of a full  technology switch to Gen-3. Having canceled the Gen-3 acquisition, DHS continues to rely on the  Gen-2 system for early detection of an aerosolized biological attack. However, we found DHS lacks reliable information about BioWatch Gen- 2’s technical capabilities to detect a biological attack, in part, because in  the 12 years since BioWatch’s initial deployment, DHS has not developed  technical performance requirements for Gen-2. DHS has  commissioned tests of Gen-2’s technical performance characteristics, but  DHS has not developed performance requirements that would enable it to  interpret the test results and draw conclusions about the system’s ability  to detect attacks. In our September 2015 report, to help ensure that biosurveillance-related  funding is directed to programs that can demonstrate their intended  capabilities, and to help ensure sufficient information is known about the  current Gen-2 system to make informed cost-benefit decisions about  possible upgrades and enhancements to the system, we recommended  that DHS not pursue upgrades or enhancements to the current BioWatch  system until it establishes technical performance requirements necessary  for a biodetection system to meet a clearly defined operational objective  for the BioWatch program; assesses the Gen-2 system against these  performance requirements; and produces a full accounting of statistical  and other uncertainties and limitations in what is known about the  system’s capability to meet its operational objectives. DHS concurred and  is taking steps to address the recommendation.
Why GAO Did This Study

The potential threat of a naturally occurring pandemic or a terrorist attack with a biological weapon of mass destruction underscores the importance of a national biosurveillance capability—that is, the ability to detect biological events of national significance to provide early warning and information to guide public health and emergency response. The Implementing Recommendations of the 9/11 Commission Act of 2007 addresses this capability, in part by creating NBIC. The center was tasked with integrating information from human health, animal, plant, food, and environmental monitoring systems across the federal government, to improve the likelihood of identifying a biological event at an earlier stage. Similarly, DHS's BioWatch program aims to provide early indication of an aerosolized biological weapon attack.
GAO has published a series of reports on biosurveillance efforts spanning more than a decade. This statement describes progress and challenges GAO has reported in DHS's implementation of NBIC and BioWatch and considerations for the future of biosurveillance efforts at DHS.
This testimony is based on previous GAO reports issued from December 2009 through September 2015 related to biosurveillance. To conduct our prior work, we reviewed relevant presidential directives, laws, policies, and strategic plans; and interviewed federal, state, and industry officials, among others. We also analyzed key program documents, including test plans, test results, and modeling studies.

What GAO Found

Since 2009, GAO has reported on progress and challenges with two of the Department of Homeland Security's (DHS) biosurveillance efforts—the National Biosurveillance Integration Center (NBIC) and the BioWatch program (designed to provide early detection of an aerosolized biological attack). In December 2009, GAO reported that NBIC was not fully equipped to carry out its mission because it lacked key resources—data and personnel—from its partner agencies, which may have been at least partially the result of collaboration challenges it faced. For example, some partners reported that they did not trust NBIC to use their information and resources appropriately, while others were not convinced of the value that working with NBIC provided because NBIC's mission was not clearly articulated. GAO recommended that NBIC develop a strategy for addressing barriers to collaboration and develop accountability mechanisms to monitor these efforts. DHS agreed, and in August 2012, NBIC issued the NBIC Strategic Plan, which is intended to provide NBIC's strategic vision, clarify the center's mission and purpose, and articulate the value that NBIC seeks to provide to its partners, among other things. In September 2015, GAO reported that despite NBIC's efforts to collaborate with interagency partners to create and issue a strategic plan that would clarify its mission and the various efforts to fulfill its three roles—analyzer, coordinator, and innovator—a variety of challenges remained when GAO surveyed NBIC's interagency partners in 2015. Notably, many of these partners continued to express uncertainty about the value NBIC provided. GAO identified options for policy or structural changes that could help NBIC better fulfill its biosurveillance integration mission, such as changes to NBIC's roles.
Since 2012, GAO has reported that DHS has faced challenges in clearly justifying the need for the BioWatch program and its ability to reliably address that need (to detect attacks). In September 2012, GAO found that DHS approved a next-generation BioWatch acquisition in October 2009 without fully developing knowledge that would help ensure sound investment decision making and pursuit of optimal solutions. GAO recommended that before continuing the acquisition, DHS reevaluate the mission need and possible alternatives based on cost-benefit and risk information. DHS concurred and in April 2014, canceled the acquisition because an alternatives analysis did not confirm an overwhelming benefit to justify the cost. Having canceled the next generation acquisition, DHS continues to rely on the currently deployed BioWatch system for early detection of an aerosolized biological attack. However, in 2015, GAO found that DHS lacks reliable information about the current system's technical capabilities to detect a biological attack, in part because in the 12 years since BioWatch's initial deployment, DHS has not developed technical performance requirements for the system. GAO reported in September 2015 that DHS commissioned tests of the current system's technical performance characteristics, but without performance requirements, DHS cannot interpret the test results and draw conclusions about the system's ability to detect attacks. DHS is considering upgrades to the current system, but GAO recommended that DHS not pursue upgrades until it establishes technical performance requirements to meet a clearly defined operational objective and assesses the system against these performance requirements. DHS concurred and is working to address the recommendation.