Biosurveillance: Preliminary Observations on Department of Homeland Security's Biosurveillance Initiatives
Published: 2008-07-16T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The United States faces potentially dangerous biological threats that occur naturally or may be the result of a terrorist attack. The Department of Homeland Security (DHS) is developing two major initiatives to provide early detection and warning of biological threats: the National Biosurveillance Integration Center (NBIC), a center for integrating and coordinating information on biological events of national significance, and the BioWatch program that operates systems used to test the air for biological agents. The Implementing Recommendations of the 9/11 Commission Act of 2007 requires DHS to establish a fully operational NBIC by September 30, 2008. This statement discusses the status of DHS's efforts to (1) make NBIC fully operational by the mandated deadline, and (2) improve the BioWatch program's technology. GAO's preliminary observations of these two programs are based on our ongoing work mandated by the Implementing Recommendations of the 9/11 Commission Act of 2007 to review U.S. biosurveillance efforts. To conduct this work, GAO reviewed related statutes; federal directives; and DHS planning, development, and implementation documents on these two initiatives. We also interviewed DHS program officials to obtain additional information about NBIC and BioWatch. DHS reviewed a draft of this testimony and provided technical comments, which were incorporated as appropriate.
section_title: What GAO Found
paragraphs: DHS has made progress making NBIC fully operational by September 30, 2008, as required by the Implementing Recommendations of the 9/11 Commission Act of 2007, but it is unclear what operations the center will be capable of carrying out at that point. DHS has acquired facilities and hired staff for the center but has not yet defined what capabilities the center will have in order to be considered fully operational. DHS has also started to coordinate biosurveillance efforts with other agencies, but DHS has not yet formalized some key agreements to fulfill NBIC's integration mission. For example, DHS has signed memoranda of understanding with 6 of 11 agencies DHS identified to support the operations of NBIC. However, DHS has not yet completed other key agreements to, for example, facilitate the technical exchange of information, such as data on human health, between NBIC and the agencies. In addition, a contractor DHS hired to enhance NBIC's information technology system delivered an upgrade to the system on April 1, 2008, intended to enhance data integration capabilities. However, before this upgrade can be used effectively, DHS officials said that NBIC will need to train its employees to use the system and negotiate interagency agreements to define the data that the agencies using the system will provide. DHS officials expect that NBIC will complete the training in early 2009. DHS has two ongoing efforts to improve the detection technology used by the BioWatch program, which deploys detectors to collect data that are then analyzed to detect the presence of specific biological agents. First, the Directorate for Science and Technology (S&T) within DHS is developing next-generation detectors for the BioWatch program. DHS plans for this new technology to collect air samples and automatically test the samples for a broader range of biological agents than the current technology. Under the current system, samples are manually collected and taken to a laboratory for analysis. DHS plans to operationally test and evaluate the new automatic technology in April 2009 and to begin replacing its existing detection technology in 2010. Operational testing and evaluation of the new technology is planned to take place in April 2009, about 1 year later than DHS initially planned, because S&T officials received revised requirements for the new system about 4 months before S&T was scheduled to complete development of the system. Second, while S&T is completing its work on the new detection technology, DHS is developing an interim solution, managed by the Office of Health Affairs, to enhance its current detection technology. This interim solution is intended to automatically analyze air samples for the same number of biological agents currently monitored by the BioWatch program. Contingent on successful operational testing and evaluation that is to start in November 2008, DHS plans to decide whether to acquire over 100 of these enhanced detectors.

section_title: Letter
paragraphs: I am pleased to have the opportunity to be here today to discuss some  issues associated with the Department of Homeland Security’s (DHS)  biosurveillance initiatives, specifically the National Biosurveillance  Integration Center (NBIC) and the BioWatch program. The United States  faces potentially dangerous biological threats that occur naturally or may  be the result of a terrorist attack. New diseases, such as Avian Influenza,  West Nile virus, and severe acute respiratory syndrome (SARS) have  emerged in recent years. Infectious diseases have the potential to develop  into widespread outbreaks and could have significant consequences, such  as causing hundreds of thousands of casualties, disrupting and weakening  our economy, damaging public morale and confidence, and threatening  our national security. In addition to naturally occurring infectious disease  outbreaks, the United States faces the possibility that terrorists will use  biological agents as weapons of mass destruction. Threats of bioterrorism,  such as anthrax attacks and high-profile disease outbreaks, have drawn  attention to the need for systems that provide early detection and warning  about biological threats, known as biosurveillance systems. DHS, in  cooperation with various other federal agencies, is developing two major  initiatives to provide early detection and warning about biological threats:  NBIC, a center for integrating information on biological events of national  significance, which the Implementing Recommendations of the 9/11  Commission Act of 2007 (9/11 Commission Act) mandated DHS to  establish and make fully operational by September 30, 2008, and the  BioWatch program, which operates systems to test the air for specific  biological threats.
My remarks today will focus on the status of DHS’s efforts to (1) make  NBIC fully operational by the statutorily mandated deadline and (2)  improve the technology used by the BioWatch program. Our preliminary  observations of these two DHS programs are based on our ongoing review  of U.S. biosurveillance efforts, as required by the 9/11 Commission Act.  The law mandates that GAO review U.S. biosurveillance efforts at the  federal, state, local, and tribal levels of government. Our preliminary  observations on NBIC and the BioWatch program are based on reviews of  DHS planning, development, and implementation documents concerning  these initiatives; related statutes and federal directives; and interviews  with DHS officials. We interviewed officials from the Office of Health  Affairs (OHA) responsible for establishing NBIC and managing the  BioWatch program. We also interviewed officials from DHS’s Directorate  for Science and Technology (S&T), the primary research and development  office responsible for developing next-generation detection technology for  BioWatch. We conducted our work from February 2008 to July 2008 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
paragraphs: Since the attacks of September 11, 2001, there has been concern that  another terrorist attack on U.S. soil could occur involving biological,  chemical, radiological, or nuclear weapons. Concerns like these have  prompted increased federal attention to and investment in national  emergency preparedness—that is, the nation’s ability to prevent, protect  against, respond to, and recover from large-scale emergency events.  Effective preparation for, detection of, and response to a major biological  event requires effective pre- and postdisaster coordination and  cooperation among different federal agencies, levels of government,  nongovernmental organizations, and the private sector. In the case of  biological threats, detection of biological agents is a first step in an  effective response to a natural, accidental, or intentional outbreak of a  biologically caused disease.
In August 2007, the 9/11 Commission Act required DHS to establish NBIC  to detect, as early as possible, a biological event of national concern that  presents a risk to the United States, or the infrastructure or key assets of  the United States. The 9/11 Commission Act provides that the mission of  NBIC is to enhance the capability of the federal government to:  rapidly identify, characterize, localize, and track a biological event of  national concern;  integrate and analyze data relating to human health, animal, plant, food,  and environmental monitoring systems; and    disseminate alerts to member agencies, and state, local, and tribal  governments.
The 9/11 Commission Act also requires NBIC to be fully operational by  September 30, 2008.
Prior to the passage of the 9/11 Commission Act, two presidential  directives charged federal agencies to coordinate federal efforts and  create a new biological threat awareness capacity to enhance detection  and characterization of a biological attack. In response to these  presidential directives, DHS began the National Biosurveillance  Integration System (NBIS) program in 2004 as a means of integrating  information across government agencies regarding biological events. The  NBIS program developed an IT system, also known as NBIS, to bring  together various data used for human, animal, and plant health  surveillance; environmental monitoring data; and intelligence and threat  analysis. Subsequently, the 9/11 Commission Act established NBIC as the  entity responsible for, among other things, developing and running the IT  system, still known as NBIS. Since it was created in March 2007, OHA has  overseen NBIS and now the NBIC program office.
DHS, in cooperation with other federal agencies, created the BioWatch  program in 2003 to detect the release of airborne biological agents. The  BioWatch program deploys detectors which collect data that, when  analyzed, can be used to identify biological agents on the BioWatch threat  list. Current BioWatch detection technology contains filters that collect  air samples, but the filters must be collected manually, and testing of the  samples is carried out in state and local public health laboratories. Using  this manual process, results are usually obtained within 10 to 34 hours of  an agent’s detection. BioWatch detectors are currently deployed in 30  cities, and local jurisdictions are responsible for the public health  response to positive findings in the BioWatch program. OHA has  responsibility for managing the operations of the BioWatch program. S&T,  which is the primary research and development arm of DHS, is responsible  for developing detectors for the BioWatch program.
section_title: DHS Has Made Progress in Making NBIC Fully Operational by the Mandated September Deadline, but Faces Difficulties Completing Key Tasks
paragraphs: DHS has made progress making NBIC fully operational by September 30,  2008, as required by the 9/11 Commission Act, but has faced difficulties  completing some key tasks, such as defining what capabilities the center  will provide once fully operational, formalizing agreements to obtain  interagency coordination, and fully implementing its IT system. NBIC has  not yet defined what capabilities the center should have in place in order  to be fully operational. According to NBIC officials, NBIC has drafted, but  not finalized, planning documents to define these capabilities. In addition,  NBIC has initiated coordination with member agencies through  memoranda of understanding (MOUs) and interagency working groups.  NBIC is working to establish additional coordination efforts to enhance  NBIC’s integration capabilities. Further, a contractor DHS hired to  enhance NBIC’s IT system delivered an upgrade to the system on April 1,  2008, but more work remains to be done. For example, member agencies  will not have full access to the IT system until NBIC employees have been  trained to use the system. Additionally, NBIC reports that it continues to  negotiate agreements with member agencies on the data they are to  provide for the IT system.
subsections: section_title: Progress Has Been Made, but It Is Unclear What Capabilities NBIC Will Have by the September 30, 2008, Deadline
paragraphs: DHS has made progress making NBIC fully operational by the mandated  September 30, 2008, deadline; however, it is unclear what operations the  center will be capable of carrying out at that point. NBIC has acquired a  facility that accommodates office space, a 24-hour watch center, as well as  secure areas to handle classified materials. Additionally, in January 2008  NBIC hired a permanent Director to oversee NBIC operations. As of July  2008, NBIC has also filled 26 of 37, or 70 percent, of NBIC’s available staff  positions, and according to NBIC officials, NBIC is in the process of hiring  four additional staff members, including a Deputy Director. NBIC officials  are planning to use contractors to fill the remaining 7 positions.  Furthermore, NBIC has also acquired one detailee from a member agency,  the Department of Health and Human Services, and is working to acquire  additional detailees. NBIC has drafted a concept of operations; a finalized  version is pending comments from NBIC’s member agencies. Officials  have also drafted, but not finalized, standard operating procedures. In  fiscal year 2008, $8 million were available to NBIC officials to establish the  center; officials told us that they recently requested an additional $4.2  million in a reprogramming that DHS has not yet approved.
NBIC has not yet defined the capabilities the center should have in order  to be considered fully operational. The 9/11 Commission Act does not  define fully operational or what capabilities NBIC needs to have in place  by the statutorily mandated September 30, 2008, deadline. NBIC officials  told us that they are currently trying to define “fully operational” and are  drafting detailed plans for the final 90 days of planning before the  deadline. Officials told us that these documents describe the details of  NBIC’s expected operational capabilities and functions, such as the state  of their IT system, personnel expectations, analytic capabilities, and  include specific goals, objectives, milestones, and cost estimates. DHS did  not provide us with these planning documents because the documents are  in draft form.
section_title: NBIC Has Taken Steps to Coordinate with Federal Agencies, but Has Not Formalized Agreements to Obtain Their Cooperation
paragraphs: NBIC has initiated coordination efforts with 11 federal agencies but faces  difficulties completing formal agreements to obtain their cooperation.  Since the new NBIC Director started in January 2008, NBIC has organized  interagency working groups and has finalized MOUs with 6 of the 11  agencies that NBIC identified as important to the operational needs of the  center. NBIC has an interagency working group consisting of these 11  agencies, in addition to DHS, that first met under the direction of the new  Director in March 2008. As part of the interagency working group, DHS  officials stated, NBIC has created a sub-working group that meets on a  weekly basis to discuss issues such as the daily operations of NBIC,  reporting requirements, and data-sharing issues. NBIC also organized an  interagency oversight council, which includes representatives from  member agencies, private-sector organizations, and academia, to provide  technical oversight and guidance in the development and implementation  of NBIC’s operations. The oversight council plans to meet for the first time  in August 2008. NBIC has begun facilitating interagency coordination  while continuing to implement additional elements of the program. For  example, NBIC officials told us that they helped coordinate the federal  government’s efforts to deal with the recent national salmonella outbreak,  while simultaneously continuing to work on making NBIC fully  operational to meet the September 30, 2008, deadline.
As part of its efforts to establish interagency coordination, NBIC is seeking  to formalize its relationship with federal agencies through three types of  documents: MOUs, interagency security agreements (ISAs), and  interagency agreements (IAAs). First, DHS is asking federal agencies to  sign MOUs to confirm the agency or department’s initial agreement to  participate in NBIC as a member agency. Second, DHS is asking agencies  to sign ISAs that formalize the technical exchange of information, such as  data on human health, between NBIC and these agencies. Finally, DHS is  asking agencies to sign IAAs that define programmatic, financial, and  staffing arrangements between NBIC and these agencies. As part of the  IAAs, agencies are to agree to provide detailees to work at NBIC. These  detailees will provide subject-matter expertise and facilitate NBIC  coordination with their respective home department or agency.
To date, NBIC and potential member agencies have finalized 6 of 11 MOUs;  however, they have not finalized any ISAs or IAAs. DHS has signed MOUs  with the Departments of Defense, Agriculture, Health and Human Services,  Interior, State, and Transportation. DHS is still working to finalize MOUs  with another 5 agencies to formalize their membership in NBIC. NBIC  does not have ISAs or IAAs in place with any of its current and potential  member agencies. According to NBIC officials, one difficulty in finalizing  the ISAs is due, in part, to defining the data-sharing arrangements with  member agencies given the constraints on arrangements for sharing data  imposed by the traditional roles of these agencies. For example,  interagency coordination for the purposes of characterizing a biological  event may require data that NBIC member agencies have not previously  shared with other agencies. In addition, DHS faces difficulty finalizing  IAAs, the formal mechanisms through which NBIC obtains detailees from  federal agencies. In the absence of IAAs, according to NBIC’s draft  concept of operations, the center cannot effectively perform its integration  and analytical mission without the subject-matter knowledge from  interagency detailees. As of July 2008, NBIC has been able to secure one  detailee from a member agency. Officials were unable to predict how  many additional MOUs, ISAs, IAAs, or detailees NBIC will have in place by  September 30, 2008.
section_title: NBIC Recently Upgraded Its IT System, but Additional Work Remains
paragraphs: A contractor DHS hired to enhance NBIC’s IT system delivered an upgrade  to the system in April 2008; however, NBIC officials stated that they need  to complete additional work before granting member agencies full access  to the system. The system, known as NBIS, provides tools to enhance  NBIC’s data integration capabilities and collaboration with member  agencies. Such tools include a worldwide geographical map displaying  emergent and ongoing adverse health events, an assessment of the  homeland security implications of those events, a library of all referenced  data, and general disease and situational reports. NBIC officials told us  that additional work needs to be done before giving member agencies full  access to the system. For example, NBIC does not have interagency  security agreements in place with member agencies that specify the data  that agencies will share with the system. In addition, as NBIC officials  work with the NBIS system, they are identifying additional improvements  that need to be made to the system. Furthermore, while member agencies  will have access to some of the individual tools that are a part of NBIS,  until NBIC analysts have been trained to use NBIS, member agencies will  not have full access to all of the system’s interagency collaboration  functions. Officials estimate that training will not be completed until at  least early 2009.
section_title: DHS Has Two Ongoing Efforts to Improve the BioWatch Technology, Which May Decrease Detection Time or Increase the Number of Agents That Can Be Identified
paragraphs: DHS has two ongoing efforts to improve the detection technology used by  the BioWatch program. S&T is developing a new technology. OHA is  developing an interim solution to enhance the detectors currently in use.
S&T is developing new detection technology known as Generation 3.0  which would replace the existing technology used by the BioWatch  program. This new technology is to provide a fully automated detector  which not only collects air samples but also analyzes them for threats. The  current technology collects air samples which are periodically manually  removed from the equipment and taken to a laboratory for analysis, a  process that could take 10 to 34 hours. Officials stated that automating  analysis of air samples could reduce the elapsed time between air  sampling and testing it for threats from the current 10 to 34 hours to 4 to 6  hours, reducing detection time by at least 4 hours and possibly as much as  30 hours. In addition to the automated detection capability, Generation 3.0  is to detect a broader range of identified biological agents to eventually  cover all the biological agents on the BioWatch threat list—a list of  specific biological agents that could pose a health threat if aerosolized and  released to the environment. The estimated cost for acquiring these  detectors is $80,000 to $90,000 per unit, with yearly operation and  maintenance costs of $12,000 to $41,000 per unit.
Operational testing and evaluation of this technology is scheduled for  April 2009, about a year later than initially planned because OHA provided  S&T with revised functional requirements about 4 months before S&T was  scheduled to complete the Generation 3.0 prototype detector. S&T  developed the original requirements for the Generation 3.0 technology,  which required the automatic detectors to, among other things, operate  continuously, detect more biological threats, be less expensive to operate,  and be deployed in both indoor and outdoor environments. S&T planned  to complete the development of the hardware and software and conduct  field tests of its prototype Generation 3.0 detectors by April 2008, at which  point OHA was to take responsibility for final operational testing and  evaluation of the detectors. However, OHA provided S&T with new  requirements for the Generation 3.0 detector in January 2008, which  delayed operational testing and evaluation by 1 year, from April 2008 to  April 2009. The new requirements included additional requirements and  provided additional details for some of the original requirements. For  example, OHA’s new requirements contain restrictions for the size and  weight of the Generation 3.0 detector which were not specified in the  original requirements. As a result of the 1-year delay, S&T also designed an  additional field test for the Generation 3.0 prototypes, scheduled to begin  in the first quarter of fiscal year 2009, which will occur in an urban  environment and allow for the prototypes to be tested in real-world  conditions. According to S&T and OHA officials, the Generation 3.0  detector will ultimately replace all current BioWatch detectors by 2013,  with initial deployment beginning in 2010.
While S&T is completing is work on the Generation 3.0 detectors, OHA is  developing an interim solution to enhance the detectors currently in use  by adding the capability to automatically analyze air samples for some  biological agents. OHA’s interim technology, known as Generation 2.5, is  intended to add the capability to automatically analyze air samples for the  same number of biological agents currently monitored by the existing  BioWatch detector technology. However, the enhanced detectors will not  have the capability to identify additional biological agents listed on the  BioWatch threat list. According to OHA officials, Generation 2.5 detectors  will, like Generation 3.0 detectors, reduce the elapsed time between  sampling the air and detecting a biological agent by at least 4 hours and  possibly as much as 30 hours. Further, OHA officials stated that they plan  to operationally test and evaluate new prototype detectors beginning in  November 2008 and to acquire over 100 of these new detectors, contingent  on successful completion of operational testing and evaluation. The  estimated cost for acquiring and testing these detectors is $120,000 per  unit, with yearly maintenance costs of $65,000 to $72,000 per unit.
According to DHS officials, OHA plans to deploy these new detectors both  indoors and outdoors; however, no procedural guidance exists for  responding to positive results from detectors placed indoors. According to  OHA officials, they plan to develop this guidance by October 2008 and  apply it to all future BioWatch detectors deployed indoors.
Mr. Chairman, this completes my prepared statement. I would be happy to  respond to any questions you or other Members of the Committee may  have at this time.
section_title: Contact and Acknowledgments
paragraphs: For further information regarding this testimony, please contact me or E.  Anne Laffoon, Assistant Director, at (202) 512-4199.  Michelle Cooper,  Jessica Gerrard-Gough, Tracey King, Amanda Krause, Juan Tapia-Videla,  John Vocino, and Sally Williamson made key contributions to this  testimony.
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