[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]


 
ONE YEAR LATER--IMPLEMENTING THE BIOSURVEILLANCE REQUIREMENTS OF THE 9/ 
                                 11 ACT 

=======================================================================

                                HEARING

                               before the

                        SUBCOMMITTEE ON EMERGING
                        THREATS, CYBERSECURITY,
                       AND SCIENCE AND TECHNOLOGY

                                 of the

                     COMMITTEE ON HOMELAND SECURITY
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 16, 2008

                               __________

                           Serial No. 110-128

                               __________

       Printed for the use of the Committee on Homeland Security
                                     

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                     COMMITTEE ON HOMELAND SECURITY

               Bennie G. Thompson, Mississippi, Chairman

Loretta Sanchez, California          Peter T. King, New York
Edward J. Markey, Massachusetts      Lamar Smith, Texas
Norman D. Dicks, Washington          Christopher Shays, Connecticut
Jane Harman, California              Mark E. Souder, Indiana
Peter A. DeFazio, Oregon             Tom Davis, Virginia
Nita M. Lowey, New York              Daniel E. Lungren, California
Eleanor Holmes Norton, District of   Mike Rogers, Alabama
Columbia                             David G. Reichert, Washington
Zoe Lofgren, California              Michael T. McCaul, Texas
Sheila Jackson Lee, Texas            Charles W. Dent, Pennsylvania
Donna M. Christensen, U.S. Virgin    Ginny Brown-Waite, Florida
Islands                              Gus M. Bilirakis, Florida
Bob Etheridge, North Carolina        David Davis, Tennessee
James R. Langevin, Rhode Island      Paul C. Broun, Georgia
Henry Cuellar, Texas                 Candice S. Miller, Michigan
Christopher P. Carney, Pennsylvania
Yvette D. Clarke, New York
Al Green, Texas
Ed Perlmutter, Colorado
Bill Pascrell, Jr., New Jersey

                    I. Lanier Lavant, Staff Director

                     Rosaline Cohen, Chief Counsel

                     Michael Twinchek, Chief Clerk

                Robert O'Connor, Minority Staff Director

                                 ______

   SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY, AND SCIENCE AND 
                               TECHNOLOGY

               James R. Langevin, Rhode Island, Chairman

Zoe Lofgren, California              Michael T. McCaul, Texas
Donna M. Christensen, U.S. Virgin    Daniel E. Lungren, California
Islands                              Ginny Brown-Waite, Florida
Bob Etheridge, North Carolina        Paul C. Broun, Georgia
Al Green, Texas                      Peter T. King, New York (Ex 
Bill Pascrell, Jr., New Jersey       Officio)
Bennie G. Thompson, Mississippi (Ex 
Officio)

                   Jacob Olcott, Director and Counsel

       Dr. Chris Beck, Senior Advisor for Science and Technology

                       Carla Zamudio-Dolan, Clerk

           Kevin Gronberg, Minority Professional Staff Member

                                  (II)























                            C O N T E N T S

                              ----------                              
                                                                   Page

                               Statements

The Honorable James R. Langevin, a Representative in Congress 
  From the State of Rhode Island, and Chairman, Subcommittee on 
  Emerging Threats, Cybersecurity, and Science and Technology....     1
The Honorable Michael T. McCaul, a Representative in Congress 
  From the State of Texas, and Ranking Member, Subcommittee on 
  Emerging Threats, Cybersecurity, and Science and Technology....     2

                               Witnesses
                                Panel I

Mr. Robert Hooks, Deputy Assistant Secretary for WMD and 
  BioDefense, Office of Health Affairs, Department of Homeland 
  Security:
  Oral Statement.................................................     4
  Prepared Statement.............................................     6
Mr. Eric Myers, Director, National Biosurveillance Integration 
  Center, Office of Health Affairs, Department of Homeland 
  Security:
  Prepared Statement.............................................     6
Mr. William O. Jenkins, Jr., Director, Homeland Security and 
  Justice Issues, Government Accountability Office:
  Oral Statement.................................................    11
  Prepared Statement.............................................    12
Dr. James M. Wilson, V, Chief Technical Officer and Chief 
  Scientist, Veratect Corporation:
  Oral Statement.................................................    18
  Prepared Statement.............................................    20

                                Panel II

Mr. Robert Hooks, Deputy Assistant Secretary for WMD and 
  BioDefense, Office of Health Affairs, Department of Homeland 
  Security:
  Oral Statement.................................................    41
  Prepared Statement.............................................     6
Dr. Jeffrey Stiefel, Director, BioWatch, Office of Health 
  Affairs, Department of Homeland Security:
  Prepared Statement.............................................     6
Mr. William O. Jenkins, Jr., Director, Homeland Security and 
  Justice Issues, Government Accountability Office:
  Oral Statement.................................................    43
  Prepared Statement.............................................    12
Dr. Frances Pouch Downes, State Public Health Laboratory 
  Director, Department of Community Health, State of Michigan:
  Oral Statement.................................................    44
  Prepared Statement.............................................    46

                             For the Record

Dr. David Hartley, Georgetown University Medical Center:
  Statement......................................................    28


 ONE YEAR LATER, IMPLEMENTING THE BIOSURVEILLANCE REQUIREMENTS OF THE 
                                9/11 ACT

                              ----------                              


                        Wednesday, July 16, 2008

             U.S. House of Representatives,
                    Committee on Homeland Security,
      Subcommittee on Emerging Threats, Cybersecurity, and 
                                    Science and Technology,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:19 p.m., in 
Room 311, Cannon House Office Building, Hon. James R. Langevin 
[Chairman of the subcommittee], presiding.
    Present: Representatives Langevin, Christensen, Pascrell, 
and McCaul.
    Mr. Langevin. The subcommittee will come to order.
    The subcommittee is meeting today to receive testimony on 
the current state and future course of the National 
Biosurveillance Integration Center, NBIC, and Project BioWatch.
    Before I begin my opening statement, I wanted to mention to 
the witnesses that there is a committee rule that testimony is 
supposed to be in 48 hours in advance. We got the DHS testimony 
this morning. We can't do business like that, and I will 
caution you about ever doing it again. I don't want to have the 
testimony received by this subcommittee that late ever again. 
It is unacceptable. We just can't do business that way.
    With that, good afternoon. I would like to thank my 
colleagues for their participation, and I welcome our witnesses 
here today.
    As this committee is well aware, the threat of biological 
attack is real and potentially catastrophic. As the Chairman of 
the subcommittee, I have made it a priority to address the most 
glaring vulnerabilities facing our Nation, and this is 
certainly one of them. Of equal or greater concern, of course, 
is the possibility that a naturally occurring disease outbreak 
could grow to epidemic proportions. We have held numerous 
hearings on how better to protect against biological attack, 
and today we are continuing those efforts.
    Today, our focus will be on determining whether the 
biosurveillance requirements included in the Implementing 
Recommendations of the 9/11 Act of 2007, which became law on 
August 3, 2007, have been properly implemented. The 9/11 Act 
included two key sections regarding our Nation's 
biosurveillance capabilities. Section 1101 authorized the 
National Biosurveillance Integration Center, or NBIC, and 
section 1102 requires the Government Accountability Office, 
GAO, to submit a report to Congress describing all Federal, 
State, and local biosurveillance efforts. Each of these will 
help protect against biological threats, whether man-made or 
natural.
    The key to stopping an outbreak from becoming an epidemic 
or an attack from becoming a catastrophe is early detection, 
identification, tracking, and response.
    Now, the National Biosurveillance Integration Center, NBIC, 
and the BioWatch program, housed in the Department of Homeland 
Security, are critical to this mission. Each of these programs 
are designed to provide early detection of disease outbreaks, a 
critical role in preventing or containing their spread. The 
NBIC was created to fulfill the requirements of Homeland 
Security Presidential Directive 9, ``Defense of U.S. Food and 
Agriculture,'' issued in January 2004, or better known as HSPD-
9.
    NBIC's mission is to develop robust, comprehensive, and 
fully coordinated surveillance and monitoring systems, 
including international information for animal disease, plant 
disease, wildlife disease, food, public health, and water 
quality that provides early detection and awareness of disease, 
pests, or poison agents. Section 1101 of the 9/11 Act 
authorized the NBIC and set a deadline of September 30, 2008, 
for full operation.
    I am concerned that, although progress has been made, most 
estimates are that we are still 2 years away from having the 
full participation of Federal, State, local, tribal, private 
sector, and international partners that a robust 
biosurveillance capability requires. I am hopeful that our 
witnesses can shed some light on the current obstacles to 
getting the NBIC operational.
    I also look forward to hearing, of course, from our 
witnesses on the status of the BioWatch program, which consists 
of two components, research and development activities on the 
next generation biodetectors, which are run by the DHS Science 
and Technology Directorate, while acquisition, operations, and 
management are now handled by the Office of Health Affairs.
    Today, we will focus on the current state of both NBIC and 
BioWatch. While I am concerned that each of these programs has 
lingering problems, I am hopeful that this hearing will help 
provide a course to overcome current obstacles and move these 
programs forward.
    With that, I do thank our witnesses for being here today.
    The Chair now recognizes the Ranking Member of the 
subcommittee, my partner in these efforts, the gentleman from 
Texas, Mr. McCaul, for an opening statement.
    Mr. McCaul. Let me thank the Chairman for holding this 
important hearing on the Nation's biosurveillance capabilities.
    In May 2006, the subcommittee held a hearing on the 
Department of Homeland Security's development of the Nation's 
biosurveillance architecture. Now, 2 years later and a year 
after the passage of the 9/11 Act, this hearing presents the 
opportunity to once again assess the strength of our Nation's 
surveillance capabilities.
    Detecting a bioterror attack or a naturally emergent 
disease is a critical first step to mounting an effective 
response. The sooner we detect an agent in the environment or 
in people, the better chance we have of mitigating its harmful 
consequences.
    The National Biosurveillance Integration Center and 
BioWatch are two key elements to this enterprise. No one system 
has ever attempted to integrate all the streams of 
biosurveillance data collected by Federal, State, local, and 
private entities. The NBIC is an ambitious but a critical plan 
to create a one-stop shop for human, animal, and plant 
biosurveillance information.
    The legislative origins of the NBIC can be found in the 
committee's 2006 authorization bill. Without question, the NBIC 
has its challenges, from technical hitches to interagency 
hurdles, but it has worked through many of these to become a 
more effective operating center. Most recently, it lent its 
expertise to provide surveillance data for the Nation-wide 
salmonella outbreak. I look forward to learning from our 
witnesses just how far along the Center has come.
    I also take great interest in the Department's plan for 
BioWatch. This detection program provides an environmental 
monitoring system to cities around the Nation for early 
detection of airborne biological threat agents. Having been 
required to beef up their preparedness and response plans, many 
of those jurisdictions with sensors are now better prepared for 
a bio-event. DHS has lead the way in creating groundbreaking 
Federal planning guidance for dealing with intentional release 
of a bioterrorism agent, and BioWatch has helped bring Federal, 
State, and local governments together for a common purpose. We 
await the next generation of sensors, the new technology, with 
a particular interest in whether plans for a fully automated 
indoor system are truly viable in the near future. We cannot, 
however, expect the Office of Health Affairs to effectively 
complete this work if its requested fiscal year 2009 budget is 
cut by $27 million, as the House Appropriations Committee would 
have it.
    In today's Washington Post, there was commentary on the 
hearing, this hearing and one in the Senate, regarding DNDO and 
also BioWatch. With respect to BioWatch, which is the focus of 
this hearing, they said in the Washington Post that: A 5-year-
old program to detect the airborne release of biological 
warfare agents, such as anthrax, plague, and smallpox, in more 
than 30 major U.S. cities still lacks basic technical data to 
help medical officials determine how to respond to an alert 
triggered by the sensors. Congressional investigators and State 
and local officials will report to the House Homeland Security 
Committee.
    I look forward to hearing from the four of you on this 
issue specifically, and how we can better integrate. We have 
our deadline coming up, as I understand, September. Can we 
reach that deadline? What technology is in the future to make 
this a better system?
    With that, I yield back.
    Thank you.
    Mr. Langevin. I thank the gentleman. Other Members of the 
subcommittee are reminded that, under the committee rules, 
opening statements may be submitted for the record.
    I now want to welcome our first panel of witnesses.
    Our first witness, Robert Hooks, serves as the Deputy 
Assistant Secretary for WMD and BioDefense in the Office of 
Health Affairs of the Department of Homeland Security. He is 
responsible for the Department's early detection biodefense 
programs, including the National Biosurveillance Integration 
Center and BioWatch, two Homeland Security programs that 
address animal security, food defense, and biological threat 
mitigation efforts.
    Our second witness, Eric Myers, is the director of the 
National Biosurveillance Integration Center, NBIC, starting in 
January 2008. His previous assignment was deputy director of 
NBIC, starting in September 2006.
    Our third witness is William Jenkins, director of Homeland 
Security and Justice Issues at the Government Accountability 
Office. The GAO is conducting a study of national 
biosurveillance efforts pursuant to section 1102 of the 9/11 
Act. Although the study is not yet complete, GAO has agreed to 
discuss their initial findings relevant to this hearing, and we 
do appreciate that.
    Our fourth witness on this panel is James Wilson, chief 
executive officer and chief scientist of the Veratect 
Corporation. Prior to that, he was principal investigator at 
Project Argus and a member of the Department of Homeland 
Security's National Biosurveillance Integration System, NBIS, 
concept design review team, and the first chief of analytic 
operations at the National Biosurveillance Integration Center.
    With that, and without objection, the witnesses' full 
statements will be inserted into the record.
    I want to welcome each of you here today, and I now ask 
each witness to summarize their statement for 5 minutes, 
beginning with Mr. Hooks, who will read a joint statement from 
himself and Mr. Myers.
    Welcome.

 STATEMENT OF ROBERT HOOKS, DEPUTY ASSISTANT SECRETARY FOR WMD 
    AND BIODEFENSE, OFFICE OF HEALTH AFFAIRS, DEPARTMENT OF 
    HOMELAND SECURITY, ACCOMPANIED BY ERIC MYERS, DIRECTOR, 
 NATIONAL BIOSURVEILLANCE INTEGRATION CENTER, OFFICE OF HEALTH 
            AFFAIRS, DEPARTMENT OF HOMELAND SECURITY

    Mr. Hooks. Thank you, Mr. Chairman.
    I have heard your words. I apologize that our testimony was 
in late, and I apologize sincerely for that.
    Mr. Chairman, Ranking Member McCaul, and Members of the 
subcommittee, thank you for the opportunity to testify today on 
the Department of Homeland Security's biosurveillance efforts.
    I serve as the Deputy Assistant Secretary for WMD and 
BioDefense, a division within the Office of Health Affairs.
    Also with me is Eric Myers, the director, as you mentioned, 
of NBIC.
    I appreciate your interest in this biosurveillance program 
and trust that my testimony today will provide valuable insight 
into the Department's biosurveillance initiatives to safeguard 
the Nation against a biological attack or other biological 
incidents that threaten the security of the homeland.
    The Nation continues to face the risk of a major biological 
event that could cause catastrophic loss of human life, severe 
economic damages, and significant harm to our Nation's critical 
infrastructures and key resources. The challenges we face in 
assessing current terrorist capabilities and identifying plots 
make it unlikely that we will receive actionable specific 
warning of an impending bioterrorist attack.
    Furthermore, many of these deadly biologic agents are 
accessible in nature, relatively easy to procure, and can be 
developed and transported without an advanced background in the 
biological sciences. Unlike nuclear weapons, only a few people 
with advanced laboratory knowledge in the biological sciences 
are needed to weaponize many of these deadly pathogens. As 
such, it is incredibly difficult to predict and prevent a 
biological attack from taking place.
    Having an early warning system capability against a 
biological threat is critical to reduce the potential loss of 
human life and prevent severe economic damages and other 
associated consequences.
    Our first indication of a bioterrorist attack will likely 
be through an early detection and warning system, such as 
BioWatch and the NBIC. I will discuss BioWatch further during 
the next panel. In the event that a bioterrorism event occurs 
in the homeland, a comprehensive biosurveillance capability can 
minimize the impact and duration of the event via early 
detection and characterization, broad situational awareness, 
and by facilitating early intervention and mitigation.
    Secretary Chertoff, in collaboration with other appropriate 
Federal departments and agencies, established a platform for 
information exchange between senior leaders and Federal 
partners to facilitate the early recognition of biologic 
events, including natural disease outbreaks, accidental or 
intentional use of biological agents, and emergent biohazards. 
This platform is known as the National Biosurveillance 
Integration System, NBIS.
    NBIC, the Center located at DHS headquarters, seeks to 
provide information to interagency partners via the NBIS 
platform to allow early recognition of biological events of 
national concern, both natural and manmade, in order to make 
timely response possible. Currently, 12 Federal agencies 
exchange information on the NBIS platform. Eventually, this 
platform of information exchange will evolve to include State, 
local, and tribal entities, and potentially the private sector 
and international stakeholders as well.
    We have established the NBIS Interagency Working Group, 
NIWG, which meets monthly to provide an open forum among 
Federal partners to enhance such information exchange. NBIC has 
developed a governance structure to provide senior level 
oversight of operations to ensure that the interagency goals 
and objectives are met. NBIC personnel analyze and monitor over 
530 information feeds. During these information feeds, NBIC 
develops and shares the biological common operating picture, we 
refer to it as BCOP, with the NBIS interagency partners. The 
BCOP provides a comprehensive assessment of current biological 
events, data, and trends, and their potential impacts on the 
Nation's security.
    In conclusion, developing an interagency biosurveillance 
capability focusing on biological threats in human health, 
animal, plant, food, and water is very difficult and a 
complicated task that has not been previously attempted. The 
challenge of detecting an impending bioterrorist plot and 
preventing an attack or an emergent of a naturally occurring 
pandemic outbreak is daunting. That is why Homeland Security is 
enhancing early detection warning systems to build a 
comprehensive national biosurveillance capability to prevent a 
biological threat from becoming a catastrophic event.
    Thank you for the opportunity to testify.
    [The joint statement of Mr. Hooks, Mr. Myers and Dr. 
Stiefel follow:]
   Joint Prepared Statement of Robert Hooks, Eric Myers, and Jeffrey 
                                Stiefel
                             July 16, 2008
                              introduction
    Mr. Chairman, Ranking Member McCaul, and Members of the 
subcommittee, thank you for the opportunity to testify today on the 
Department of Homeland Security's (DHS) biosurveillance efforts. I 
serve as the Deputy Assistant Secretary for WMD and Biodefense, a 
division within the Department of Homeland Security's Office of Health 
Affairs (OHA). I appreciate your interest in our biosurveillance 
programs, and trust that my testimony today will provide valuable 
insight into the Department's biosurveillance initiatives to safeguard 
the Nation against a biological attack or other biological incidents 
that threaten the security of the homeland.
    The Nation continues to face the risk of a major biological event 
that could cause catastrophic loss of human life, severe economic 
damages, and significant harm to our Nation's critical infrastructures 
and key resources. As you so vividly remember the Nation already 
experienced a form of bioterrorism in late 2001 with the deadly anthrax 
mailings that cost the lives of 5 individuals, injured 17, and caused 
severe disruptions to many of our Government activities, including 
operations of the U.S. Postal Service and numerous other functions.
    The challenges we face in assessing current terrorist capabilities 
and identifying plots make it unlikely that we will receive actionable, 
specific warning of an impending bioterrorist attack. Furthermore, many 
of these deadly biological agents are accessible in nature, relatively 
easy to procure, develop and transport without an advanced background 
in the biological sciences. Unlike nuclear weapons, few people with 
advanced laboratory knowledge in the biological sciences are needed to 
weaponize many of these deadly pathogens. As such, it is incredibly 
difficult to predict and prevent a biological attack from taking place. 
The threat of bioterrorism has not subsided, and the impact of a large-
scale bioterrorism event, such as the wide-spread dissemination of an 
aerosolized form of anthrax or other deadly biological pathogen, would 
have a serious effect on the health and security of the Nation.
    A bioterrorist plot may not have detectable signals, thus, there 
may be little or no warning of an impending biological attack, 
presenting significant challenges to the identification, detection, and 
disruption of such plots. Our first indication of a bioterrorist attack 
will likely be through early detection and warning systems, such as 
BioWatch and the National Biosurveillance Integration Center (NBIC). 
Their detection capabilities will drive the subsequent response and 
significantly influence the number of individuals affected by an 
attack.
    In the event that a threat does reach, or occur in, the homeland, a 
comprehensive biosurveillance capability can minimize the impact and 
duration of the event via early detection and characterization, broad 
situational awareness and by facilitating early intervention and 
mitigation.
                            biosurveillance
    An integrated biosurveillance program is vital to help protect the 
homeland from bioterrorism: unintentional introductions (e.g. Foot-and-
Mouth Disease); and naturally occurring biological events, such as 
pandemic influenza. Biosurveillance refers to monitoring for potential 
signs of biological events with the intent of early detection of that 
event to permit the timely response to mitigate consequences. Should an 
event occur, biosurveillance and detection allows the monitoring of an 
outbreak as it happens and provides accurate situational awareness to 
first responders. Biosurveillance is one of the critical components of 
our Nation's biodefense strategy, as outlined in Homeland Security 
Presidential Directive (HSPD) 10: Biodefense for the 21st Century.
    Biosurveillance includes many different components that work in 
complementary fashion to achieve a comprehensive awareness. This takes 
the form of both traditional and novel methods of early event detection 
including environmental detection systems, clinical syndromic 
surveillance, reportable disease and laboratory-based surveillance, 
monitoring of agricultural and wildlife activity, testing of the food 
supply, and monitoring mail and open-source analysis to name a few. 
Each is a necessary and valuable component of a comprehensive 
biosurveillance strategy. I would like to discuss two biosurveillance 
programs that the Department is leading as part of the Federal 
Government's larger biosurveillance strategy: NBIC and the Biowatch 
Early Detection System.
           national biosurveillance integration center (nbic)
    Recognizing the need to create a new biological threat surveillance 
capability across multiple sectors and domains to provide early 
awareness and warning of emerging biological events, Secretary 
Chertoff, in collaboration with the other appropriate Federal 
Departments and agencies, established the National Biosurveillance 
Integration System (NBIS), which serves as the platform for information 
exchange between senior leaders and partners agencies and facilitates 
the early recognition of biological events, including natural disease 
outbreaks, accidental or intentional use of biological agents, and 
emergent biohazards.
    Currently, twelve Federal Member Agencies comprise the NBIS 
community. Eventually, this community will evolve to include State, 
local and tribal entities, and potentially the private sector and, 
international stakeholders. The NBIS community provides situational 
awareness through the acquisition, integration, analysis and 
dissemination of information from existing human disease, food, 
agriculture, water, meteorological, and environmental surveillance 
systems and relevant threat and intelligence information.
    In 2007, Congress passed and President Bush signed Pub. L. 110-53, 
The Implementing of the 9/11 Commission Recommendations Act of 2007 
which formally authorized the establishment of the National 
Biosurveillance Integration Center (NBIC), which serves as the hub of 
operations and personnel to which the NBIS community contributes 
information. The NBIC is located in the DHS Nebraska Avenue Center and 
is charged with the primary mission to rapidly identify, characterize, 
localize, and track a biological event of national concern; integrate 
and analyze data relating to human health, animal, plant, food, water; 
and disseminate alerts and pertinent information. NBIC seeks to provide 
information to allow early recognition of biological events of national 
concern, both natural and man-made, in order to make a timely response 
possible. No other entity in Government serves to integrate this 
biological threat information from across the spectrum of public and 
private, domestic and international, open or protected sources.
    As an operating center, the vital component parts of NBIC are:
   A corps of highly trained subject matter experts (SMEs) and 
        analysts, including a 24-hour/7-day OHA Watch Desk within the 
        DHS National Operations Center;
   Tailored customer products resulting from integrative 
        analysis of biosurveillance information;
   A culture of cooperation, trust and mutual support across 
        the Federal Government and other partners; and
   A robust information management system capable of handling 
        large quantities of structured and unstructured information.
        developing an interagency information sharing capability
    Developing interagency cross-domain biosurveillance capability is a 
difficult and complicated task that has not been previously attempted. 
Coordination with our Federal partners to obtain data, personnel, and 
information-sharing agreements requires new processes and procedures. 
Additionally, building a new IT system to coordinate the information 
sharing, as well as creating new analytical tools to assist analysts in 
identifying trends, patterns, and anomalies quickly and accurately as 
is necessary for forward-looking and cueing capability has taken time. 
However, we are still scheduled to meet our full operational capability 
(FOC) goals by September 30, 2008.
    NBIC has formalized its relationship with a number of Federal 
partners, and continues to make progress on obtaining formal agreements 
with the remaining relevant Federal Agencies in order to promote a 
robust interagency biosurveillance capability. MOUs are in place with 
Departments of Defense, State, Agriculture, Interior, Health and Human 
Services, and Transportation. We are also working closely with the 
Department of Veterans Affairs, FBI, Environmental Protection Agency, 
U.S. Postal Service, and the Department of Commerce and other 
components within DHS. While final details of some of these agreements 
are being resolved, these Departments and agencies are currently 
contributing to the NBIC mission and providing valuable information on 
current bio-events.
    NBIC has established the NBIS Interagency Working Group (NIWG) 
which meets monthly to provide an open forum among NBIS members to 
discuss interagency collaboration, develop detailed operational 
procedures and offer recommendations to enhance the capability of NBIS. 
The NIWG representatives possess a detailed knowledge of their 
respective organization's biosurveillance-relevant capabilities, 
programs and activities that can contribute to the integrated effort. 
This collaboration has produced the first version of the NBIS Concept 
of Operations which lays out the details of how the mission of NBIS is 
being implemented and executed. This document is significant in that it 
describes the steps NBIS will take to accomplish the unprecedented task 
of biosurveillance cross-domain integration and analysis.
    Further, NBIC has developed a governance structure to provide 
senior-level oversight of operations to ensure that interagency goals 
and objectives are met. The National Biosurveillance Integration System 
Interagency Oversight Council is made up of representatives at the 
assistant secretary level from each NBIS member agency and acts as the 
senior oversight body to provide guidance and direction for the 
efficient operation and evolution of NBIS.
               nbic information integration and analysis
    To accomplish the biosurveillance mission, the NBIC monitors over 
530 information feeds. Monitoring of these information feeds is 
facilitated by the NBIS 2.0 IT system. These sources include 
interagency communications and 165 open-source sites. These open-source 
sites include 20 organizational sites, 14 Federal Government sites, 85 
State, local, or territorial government health and agriculture sites, 
35 foreign government sites, and 2 commercial sites.
    Using its information feeds, NBIS develops and shares a 
Biosurveillance Common Operating Picture (BCOP) with the NBIS 
community. The BCOP is a comprehensive electronic picture with 
assessments of current biological events, trends and their potential 
impacts on the Nation's homeland security. The BCOP provides a secure 
platform for cross-domain information analysis by NBIS subject matter 
experts to learn more about and collectively evaluate current 
situations. An impact assessment of an event constitutes a major 
portion of the NBIS BCOP information dissemination.
    As an example of the NBIC capability, several NBIS member agencies 
continue to work closely together to provide comprehensive situational 
awareness to Federal agencies on the current Salmonella stereotype 
Saintpaul event. NBIC remains thoroughly engaged in the tracking of 
this event, and regularly posts Situational Reports (SITREPs) on the 
BCOP. Thus far, NBIS has released 11 national SITREPs on this event.
                     nbic full operating capability
    NBIC has developed a set of goals to address the highest priority 
requirements to achieve FOC by September 30, 2008, which assumes the 
current reprogramming request before Congress. We continue to progress 
toward the following to achieve full operational capability:
   Install interagency staff and enhanced space resources for 
        NBIC;
   Enhance IT Infrastructure for biosurveillance;
   Expand the NBIS Interagency Community;
   Further develop NBIC Intra-Agency Collaboration;
   Continue NBIC Collaborative Analysis and Production;
   Refine the NBIC Five-Year Strategic Plan with modified 
        objectives; and
   Refine the NBIC Contingency Operations Plans with updated 
        strategies.
                                biowatch
    I would also like to discuss the Department's BioWatch Program, 
which was established in January 2003, and is currently managed by OHA. 
The BioWatch mission is to deploy and maintain a national 24/7 early 
warning system capable of detecting the intentional release of select 
aerosolized biological agents in order to speed response and recovery 
efforts. The purpose of this early detection and warning capability is 
to mitigate the consequences of a catastrophic attack, which could 
affect tens of thousands of people if, for example, aerosolized anthrax 
were released.
    The goals of the BioWatch Program include:
   Early detection and characterization of biological attacks 
        against the Nation's cities, high value assets, and mass 
        gatherings to allow for the rapid distribution of life-saving 
        countermeasures;
   Cost-effectively improving bio-aerosol threat monitoring 
        capability and increasing its capacity to cover a greater 
        portion of the general population;
   Providing operational and consequence management guidance 
        and assistance to Federal, State, local, and tribal entities; 
        and
   Integrating BioWatch capabilities into a national bio-threat 
        monitoring and response system.
    BioWatch is part of a national biodefense strategy that includes 
intelligence, law enforcement, bio-monitoring, situational awareness, 
decision support, response, and recovery activities. Within this 
strategy, BioWatch is an essential component of bio-monitoring, along 
with astute clinicians, syndromic surveillance, food and agriculture 
monitoring, veterinary surveillance, and mailroom monitoring. BioWatch 
technical and operational capabilities are integrated with military 
capabilities at installations to the benefit of both the Department of 
Defense and DHS.
    Bio-monitoring of infectious agents will enable earlier treatment 
of affected populations than would otherwise be possible, and 
contribute to the prevention of secondary transmission, thereby 
reducing morbidity, mortality, and the associated health care costs 
from a biological terrorist attack. Each component of bio-monitoring 
relies on different technologies and techniques that are optimized for 
their intended purpose. It is through situational awareness and 
decision support that bio-monitoring is linked with the public health 
and medical response communities that must respond in the event of a 
biological terrorist event.
                      current biowatch capability
    The current generation BioWatch system, which is operating in over 
30 of the Nation's largest metropolitan areas, is composed of aerosol 
collectors, secondary sampling kits, laboratories, guidance documents, 
concepts of operation, communications protocols, an internet-based 
information portal, subject matter experts, and a small number of early 
generation indoor detectors. System operation requires the integration 
and coordination of Federal, State, and local authorities whom all play 
an active role in the program. The system is tested routinely at each 
of the local jurisdictions where it is deployed.
    The BioWatch program has established and strengthened existing 
local infrastructure. Laboratory procedures and field operations have 
been standardized and are reviewed periodically for quality assurance 
by the BioWatch program. Detailed environmental sampling plans have 
been developed that could be used to gather information about the 
viability and distribution of a bio-agent detected by the system.
    BioWatch laboratories that analyze filters taken each day from the 
aerosol collectors are part of the Laboratory Response Network (LRN). 
Laboratory personnel follow strict protocols using laboratory assays 
that were developed jointly by the CDC and Lawrence Livermore National 
Laboratory to analyze the filters for the presence of biological threat 
agents. The BioWatch laboratories have been in continuous operation 
since 2003, having analyzed more than 7 million samples without a 
single laboratory false positive result.
    If BioWatch detects the presence of a bio-agent of concern, it 
issues a signal known as a BioWatch Actionable Result (or BAR). Since 
the Program's inception, dozens of BARs have been reported by multiple 
BioWatch State and local jurisdictions. These valid laboratory findings 
have been attributed in all cases to naturally occurring environmental 
sources.
    BioWatch operational readiness is essential for the system to be 
effective. Readiness involves planning, preparedness, detection, and 
initial response. Representatives from these agencies, along with State 
and local public health and response personnel, have created guidance 
documents for local jurisdictions to use in developing operational 
plans for BioWatch.
    These guidance documents cover preparedness, response, 
environmental sampling, and indoor operations. They are reviewed and 
updated periodically by the Federal BioWatch Working Group to take 
advantage of lessons learned through training, exercises, and real-
world execution of operational plans in response to positive laboratory 
results from environmental sources.
    The operational response plans for each jurisdiction are triggered 
by a BAR and implemented by a local BioWatch Advisory Committee (or 
BAC). A BAR triggers a formal notification process whereby the local 
public health official notifies local, State and Federal partners. The 
public health official convenes the BAC via conference call to begin 
situational assessment; Federal and State partners join BAC members in 
a national teleconference within 2 hours of notification. The initial 
call may be followed by others as more pertinent information becomes 
known. Investigation and discussions continue until consensus is 
reached about the significance of the BAR, which is used to inform 
protective action decisions on the part of the local public health 
official.
    Each environmental BAR has provided local, State, and Federal 
Government personnel an opportunity to exercise its preparedness plans 
and coordination activities that are fundamental to an effective 
response to a bioterrorism event or some other incident of public 
health significance. These real world events have been a catalyst for 
collaboration among local, regional, State, and Federal authorities, 
resulting in greater integration of public health, medical, veterinary, 
laboratory, emergency response, and critical infrastructure personnel 
responsible for consequence management across the full spectrum of 
public health threats facing our Nation.
    BioWatch technical and operational capabilities are also integrated 
with related military capabilities at installations around the country 
to the benefit of both DHS and the Department of Defense. It is through 
situational awareness and decision support that bio-monitoring is 
linked with the public health and medical response communities that 
must respond in the event of a biological terrorist event.
                 developing future biowatch capability
    The BioWatch system continues to evolve with new technologies, new 
partnerships with other bio-monitoring activities in the Government and 
private sector, and a refined national bio-monitoring architecture. We 
are striving to further the BioWatch system technologies and improve 
procedures to reduce the time-to-detect between biological agent 
release, detection and follow-on response. We are also working to 
increase the number of biological agents that are detected and to 
increase the population coverage in existing BioWatch jurisdictions, 
including in the highest risk indoor facilities.
    We are striving to improve the detection capabilities of the 
system, while ensuring that appropriate testing and evaluation control 
processes are in place. We are working with DHS's Testing and 
Evaluation team on future technology developments to ensure the 
appropriate level of independent oversight to make informed decisions 
regarding deploying improved technologies and reducing risk of 
technological shortcomings.
    One of our high-priority initiatives is to replace collectors--the 
filters of which require formal laboratory analysis--with automated 
detectors, wherein the analysis is performed within the unit itself. 
The primary objective of the Generation 3 system is the development of 
automated detectors that will significantly reduce the time to detect a 
biological agent from the current 10 to 34 hours down to between 4 and 
6 hours which will potentially save thousands of lives for each day an 
attack, such as anthrax, is detected ahead of human syndromic 
surveillance and other public health indicators.
    The BioWatch operational requirements (e.g., logistics, readiness 
and interoperability) stem from OHA's experience operating the system. 
Detailed requirements are captured in the Generation 3 Operational 
Requirements Document. That document is our guide for ensuring that the 
best automated detection system will be selected and fielded. The 
responsibilities for technical improvements and supporting R&D are 
jointly shared by DHS's Science and Technology (S&T) Directorate and 
OHA. Technologies under consideration must meet operational 
requirements for performance, operability, and reliability. As with any 
upgrade to a complex system, it is not as simple as plugging in a new 
component and assuming that the technology will work well and integrate 
properly with all other material and non-material elements of the 
system. To ensure new technology deployments are successful, candidate 
detectors need to be thoroughly tested under real-world operational 
conditions.
    The operational test and evaluation of automated detectors under 
consideration for inclusion in the BioWatch Generation 3 system are 
scheduled to begin in April 2009. The tests will be conducted in two 
BioWatch jurisdictions over a period of 3 to 6 months. A procurement 
decision will then be made; the initial deployment of the BioWatch 
Generation 3 system is planned for fall 2010. The Generation 3 system 
will be operated along side Generation 2 systems for a period of 60 to 
90 days to facilitate the transition to the enhanced system.
    BioWatch deployment strategies are derived from risk-based analyses 
that account for threat, vulnerability, and consequences. Our plan is 
to continue increasing the population coverage in existing BioWatch 
jurisdictions, as well as expand coverage to new locations or 
facilities when the risk is determined to be high enough to warrant 24/
7 environmental monitoring.
    Given the current system's lag time between an attack and 
detection, DHS believes it is necessary to procure and deploy an 
interim automated system which we call Generation 2.5 designed to 
reduce notification times to as little as 4 to 6 hours. This interim 
system will be deployed in high-consequence indoor environments to 
provide coverage of the highest risk facilities before the Generation 3 
system will be ready for deployment.
    The BioWatch program will continue to reduce the risks associated 
with bioterrorism and continues to develop future technology options 
and best deployment options. This will provide increased safety to the 
American public through early detection of biological pathogens that 
threaten our public health.
                               conclusion
    Biological threats to the homeland continue to be of concern. We 
are facing persistent and evolving terrorist threats with potentially 
catastrophic consequences. A catastrophic biological event, such as a 
WMD terrorist attack, or a naturally occurring pandemic or emerging 
disease outbreak, could cause hundreds of thousands of casualties, 
damage our economy and the public's confidence, and threaten the 
security of our homeland. As I stated earlier, the challenge of 
detecting an invisible footprint of an impending bioterrorist plot and 
preventing an attack or the emergence of a pandemic is daunting. That 
is why DHS is taking the approach of enhancing early detection systems 
and building a national biosurveillance capability for situational 
awareness--to prevent a biological event from becoming a Nation-
changing catastrophic event.
    Our goal is to generate timely and comprehensive information about 
a biological event and put it into the hands of decisionmakers 
responsible for the continuity of society and Government. I have 
observed in today's vernacular that ``time zero'' when a response can 
be initiated is often referred to as the time an event is known to have 
occurred, not when the event actually occurred. The time lag between 
the true ``time zero'' when an event occurs and when it is recognized 
is critical in determining how successful a response will be in 
mitigating loss of life and suffering. DHS is committed to improving 
the Nation's biodetection and biosurveillance capabilities so that we 
can achieve a ``time zero'' as close to the true time of the actual 
event as possible.
    I appreciate the opportunity to share the vision, status and 
direction of the NBIC and BioWatch biosurveillance programs with you 
and look forward to your comments and guidance on how to better shape 
the programs to protect the American public against intentional and 
natural biological events. Thank you for the opportunity to testify. I 
would be happy to provide answers to any questions that you may have.

    Mr. Langevin. I thank the witness.
    The Chair now recognizes Mr. Jenkins to summarize his 
statement for 5 minutes.
    Welcome.

   STATEMENT OF WILLIAM O. JENKINS, JR., DIRECTOR, HOMELAND 
 SECURITY AND JUSTICE ISSUES, GOVERNMENT ACCOUNTABILITY OFFICE

    Mr. Jenkins. Thank you. Chairman Langevin, Ranking Member 
McCaul, and Members of the subcommittee.
    The 9/11 Commission Act mandated that GAO review 
biosurveillance efforts at the Federal, State, local, and 
tribal levels of Government. That review is ongoing.
    I am pleased to be here today to discuss our preliminary 
operations on DHS's efforts to establish a fully operational 
National Biosurveillance Integration Center by the statutorily 
mandated September 30 deadline. DHS has not finalized the 
capabilities that the Center must have to be fully operational, 
nor has it clearly identified the capabilities it anticipates 
NBIC will have as of September 30 of this year.
    The former acting director of NBIC testified last October 
that NBIC has three vital components of success: One, a robust 
information management system capable of handling large 
quantities of structured and unstructured information. Two, a 
core of highly trained subject matter experts and analysts. 
Three, a culture of cooperation, trust, and mutual support 
across the Federal Government and other partners.
    DHS and NBIC leadership have taken steps in each of these 
areas, such as filling 26 of 37 authorized positions, hiring a 
permanent staff director, acquiring facilities for NBIC that 
can accommodate classified data, creating a 24-hour watch 
center, and reaching out to 11 other agencies that DHS has 
identified as having analytical resources and data useful to 
NBIC's integration mission.
    The success in achieving the first two objectives, a robust 
information management system and a core of subject matter 
experts to analyze data, are dependent upon obtaining the 
cooperation and substantive participation of agencies with 
relevant data and expertise. DHS has reached out to these 
agencies but had limited success to date in completing three 
types of agreements with each agency: First, memorandums of 
understanding, in which the agencies agree to participate as a 
member of NBIC. Six of the 11 agencies have signed MOUs with 
NBIC, Department of Defense, Agriculture, Health and Human 
Services, State, Interior, and Transportation. Five agencies 
have not yet signed MOUs, the FBI, Veterans Administration, 
Postal Service, EPA, and the National Oceanic and Atmospheric 
Administration.
    Second, interagency agreements that describe the 
programmatic, financial, and staffing between NBIC and 
participating agencies. None of these agreements have yet been 
finalized. Only one agent, CDC, has provided a detailee to 
NBIC.
    Third, interagency security agreements that formalize the 
types of data that agencies will share with NBIC's IT system 
and their access to that system. None of these agreements have 
been signed, either.
    It is important to note that DHS cannot compel the 
participation of these 11 agencies. As in many other areas in 
which DHS is trying to develop cross-agency programs, the 
principle challenge is getting the full cooperation of agencies 
that have not historically cooperated and worked together in a 
fully integrated manner.
    Finally, on April 1, 2008, a contractor delivered to NBIC 
an upgrade to its information technology system intended to 
enhance its data integration capabilities. However, DHS 
officials said that before this upgrade can be used 
effectively, NBIC will need to train its employees to use the 
system, training that it expects to complete in early 2009. In 
addition, NBIC will need to negotiate the previously mentioned 
interagency agreements to define the data participating 
agencies will provide for the system and their access to that 
system. It is not clear when that may be completed.
    That concludes my statement, Mr. Chairman. I would be 
pleased to respond to any question you or other Members of the 
subcommittee may have.
    [The statement of Mr. Jenkins follows:]
             Prepared Statement of William O. Jenkins, Jr.
                             July 16, 2008
                             gao highlights
    Highlights of GAO-08-960T, a testimony before the Subcommittee on 
Emerging Threats, Cybersecurity, and Science and Technology, Committee 
on Homeland Security, House of Representatives.
Why GAO Did This Study
    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.
  biosurveillance: preliminary observations on department of homeland 
                 security's biosurveillance initiatives
What GAO Found
    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.
    Mr. Chairman and Members of the committee: 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,\1\ and the BioWatch program, which 
operates systems to test the air for specific biological threats.
---------------------------------------------------------------------------
    \1\ Pub. L. No. 110-53,  1101, 121 Stat. 266, 375-79 (2007).
---------------------------------------------------------------------------
    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.\2\ 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.
---------------------------------------------------------------------------
    \2\ Id. at  1102, 121 Stat. at 379.
---------------------------------------------------------------------------
                                summary
    DHS has made progress making NBIC fully operational by September 
30, 2008; however, it is unclear what operations the center will be 
capable of carrying out at that point. DHS 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 completing work related to the new 
information technology (IT) system. For example, NBIC has made some 
progress in developing its capabilities to be fully operational by 
September 30, 2008, as mandated by the 9/11 Commission Act, but NBIC 
has not yet defined the capabilities the center will have in order to 
be considered fully operational. DHS, through NBIC, has also started to 
coordinate interagency biosurveillance efforts and finalized some, but 
not all, key interagency coordination documents. For example, DHS has 
yet to finalize interagency agreements with relevant agencies that 
describe programmatic, financial, and staffing arrangements between 
NBIC and these agencies. In addition, a contractor DHS hired to enhance 
NBIC's IT system delivered an upgrade to the system on April 1, 2008; 
however, NBIC officials stated that they need to complete additional 
work before granting other agencies full access to the new system. For 
example, NBIC is still in the process of training employees to use the 
system and negotiating agreement on the data that agencies will provide 
to NBIS.
    DHS has two ongoing efforts to improve the detection technology 
used by the BioWatch program. First, S&T within DHS is developing new 
detectors for the BioWatch program, a program that deploys detectors to 
collect data that are then analyzed to detect the presence of specific 
biological agents. These new detectors, known as Generation 3.0, are 
intended to provide additional capabilities and replace the existing 
detection technology beginning in 2010. The new detector technology is 
designed to both collect and automatically test air samples for 
biological agents, unlike the current system in which samples must be 
manually collected and taken to a laboratory for analysis. DHS 
officials anticipate that the new technology will reduce the elapsed 
time between air sampling and detection of a biological threat by at 
least 4 hours and possibly as much as 30 hours. Additionally, the new 
technology is designed to detect more biological agents than the 
existing technology. 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 requirements 
about 4 months before S&T was scheduled to complete the development of 
the new prototype detector. Second, while S&T completes its work on the 
new detection technology, OHA is developing an interim solution to 
enhance the existing detection technology so that it can automatically 
analyze air samples. Contingent on successful operational testing and 
evaluation that is to begin in November 2008, DHS plans to acquire over 
100 of the enhanced detectors.
                               background
    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 post-disaster 
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.\3\
---------------------------------------------------------------------------
    \3\ According to the 9/11 Commission Act, the term ``member 
agency'' means any Federal department or agency that, at the discretion 
of the head of that department or agency, has entered a memorandum of 
understanding regarding participation in the NBIC. DHS is working with 
11 other Federal agencies to establish NBIC: Department of Defense, 
Department of Agriculture, Department of Health and Human Services, 
Department of the Interior, Department of State, Veteran's Affairs, 
Department of Transportation, the Environmental Protection Agency, 
Postal Service, Department of Commerce, and Department of Justice.
---------------------------------------------------------------------------
    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.\4\ 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.
---------------------------------------------------------------------------
    \4\ Homeland Security Presidential Directive (HSPD) 9, Defense of 
United States Agriculture and Food (Jan. 30, 2004), charges Federal 
agencies to create a new biological threat awareness capacity. 
Additionally, HSPD 10, Biodefense for the 21st Century (Apr. 28, 2004), 
calls for an integrated and comprehensive attack warning system that 
will assist in recognizing and responding to biological attacks on 
humans, animals, food, water, agriculture, and environmental resources.
---------------------------------------------------------------------------
    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.\5\ 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.
---------------------------------------------------------------------------
    \5\ DHS has identified a list of specific biological agents that 
could pose a health threat if aerosolized and released to the 
environment.
---------------------------------------------------------------------------
dhs has made progress in making nbic fully operational by the mandated 
    september deadline, but faces difficulties completing key tasks
    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.
Progress Has Been Made, But It Is Unclear What Capabilities NBIC Will 
        Have by the September 30, 2008, Deadline
    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.
NBIC Has Taken Steps to Coordinate With Federal Agencies, But Has Not 
        Formalized Agreements to Obtain Their Cooperation
    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.\6\ 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.
---------------------------------------------------------------------------
    \6\ The five departments and agencies with pending MOUs include the 
Department of Commerce, the Environmental Protection Agency, Department 
of Justice, United States Postal Service, and Department of Veterans 
Affairs.
---------------------------------------------------------------------------
NBIC Recently Upgraded Its IT System, But Additional Work Remains
    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.
 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
    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.

    Mr. Langevin. Thank you, Mr. Jenkins.
    The Chair now recognizes Mr. Wilson for 5 minutes.

 STATEMENT OF JAMES M. WILSON, V, MD, CHIEF TECHNICAL OFFICER 
           AND CHIEF SCIENTIST, VERATECT CORPORATION

    Dr. Wilson. Thank you, sir.
    Chairman Langevin, Ranking Member McCaul, and Members of 
the subcommittee, I appreciate the opportunity to testify today 
about the Department of Homeland Security's National 
Biosurveillance Integration Center, NBIC.
    My name is Dr. James Wilson, chief scientist and chief 
technical officer at Veratect Corporation, a privately funded 
company, with offices in Seattle, Chicago, and Alexandria, 
Virginia.
    For more than 10 years now, I have been pursuing a mission 
of early disease detection and tracking. I have had the 
privilege of working with and for the World Health 
Organization, NASA, NOAA, the U.S. Army, DHS-NBIC, and several 
other Federal organizations, all with the intention of 
developing the art and science of timely, accurate, sensitive, 
and specific detection and warning for disease early enough to 
do something about it before it can spread via the global 
transportation and commerce grid.
    Perhaps the most relevant points in my career for this 
discussion today are my role as the first chief of operations 
at NBIC, principal investigator of Project Argus, founding 
member of the Biosurveillance Indication and Analysis 
Community, BIWAC, and my current role at Veratect.
    I am here today to speak about the national biosurveillance 
integration mission and what it would take to strengthen and 
hasten NBIC toward the successful completion of its 
congressional mandate to build and operate an integrated 
biological threat detection, tracking, and warning system.
    I am also here as a physician and U.S. citizen with deep 
concerns about how to best meet the growing threat of global 
disease. The threat is real. The diversity of the threats is 
growing, and increasing globalization only heightens our risk. 
So what are we as a Nation doing about the threat?
    NBIC is mandated to protect the United States from 
biological threats through effective early warning. Execution 
has fallen short, however, due to one basic point: Every 
warning system needs effective early detection. The earlier the 
better. Like hurricane, tornado, and tsunami warning systems, 
early, accurate, and specific warning of inbound disease is key 
to avoiding disaster.
    I was fortunate to lead the team at Project Argus that 
represented the best available system at the time. Despite our 
best efforts, there were operational restrictions which 
prevented Argus from reaching its full potential. Most 
importantly, we were unable to analyze domestic data, leaving a 
tremendous blind spot in the system. In addition, we were 
unable to work with international partners in order to validate 
our findings. We were also unable to share vital information 
with the global health community. These restrictions were 
mission crippling.
    Earlier this year, we set out to create from the ground up 
a more advanced methodology and operational framework that 
provides truly global reach, including domestic coverage, and 
allows us to work with private corporations and nonprofit 
organizations. This new approach is not trivial. Our ForeShadow 
engine and VeraSight interface have greatly expanded the number 
of information sources and the ability to detect and track 
emerging biological events in near realtime. Veratect's more 
open framework also allows for rapid ground verification to 
facilitate early warning and help initiate proactive response 
by working closely with both public and private resources 
around the world.
    One of our key observations over the past 10 years is it is 
the critical importance of human analysis. Human-powered 
technology drives our ability to detect diseases earlier and 
more accurately than at any time in history.
    The senior analytic team and I that I assembled at Argus is 
now at Veratect, where we now have more than 230 person years 
of international experience and nearly 100 person years within 
this new professional discipline. We currently monitor over 200 
diseases that affect humans and animals, and our methodology 
has expanded to include monitoring for food safety. For the 
first time in history, we can now do more than simply deal with 
the aftermath of such disasters as HIV/AIDS, SARS, or the H3N2 
vaccine drift this past winter, which is found in this 
commentary here in Nature this month. The team that is now at 
Veratect detected this new strain of influenza a full 6 weeks 
in advance of the WHO consultation on the composition of the 
influenza vaccine for the Northern Hemisphere in February 2007.
    We stand at the threshold of a new era in public health, 
where we can detect and perhaps anticipate public health crises 
and disasters through Veratect's groundbreaking methodology and 
global partnerships. I am here not just as a professional of 
this new discipline but as a father and a husband who is 
worried about these emerging threats and the potential effect 
on my family. This is personal for all of us. Everyone in the 
world is a stakeholder in what we do here today.
    Once again, I am grateful for this opportunity to testify, 
and I stand ready to answer any questions you might have. Thank 
you.
    [The statement of Dr. Wilson follows:]
                Prepared Statement of James M. Wilson, V
                             July 16, 2008
    Chairman Langevin, Ranking Member McCaul and Members of the 
committee, I appreciate the opportunity to testify today about the 
Department of Homeland Security National Biosurveillance Integration 
Center (NBIC).
    My name is Dr. James Wilson, Chief Scientist and Chief Technical 
Officer of Veratect Corporation, a privately funded company with 
offices in Seattle, Chicago and Alexandria, Virginia. For more than 10 
years now, I have been pursuing a mission of early disease detection 
and tracking. I have had the privilege to have worked with and for the 
World Health Organization, NASA, NOAA, U.S. Army, DHS-NBIC and several 
other Federal organizations, all with the intention of developing the 
art and science of timely, accurate, sensitive and specific detection 
and warning for disease--early enough to do something about it before 
it enters the global transportation and commerce grid. Perhaps the most 
relevant points in my career, for this discussion today, are my role as 
the first Chief of Operations at NBIC, Principal Investigator of 
Project Argus, founding member of the Biosurveillance Indication and 
Warning Analysis Community (BIWAC) and my current role at Veratect.
    Today I would like to cover five things:
    (1) A quick review of biological threats past to present.
    (2) What our Nation's response has been to date.
    (3) Speak to NBIC's mandate as it stands today, and what will be 
        required for it to succeed.
    (4) Share with you the next generation in early detection 
        methodologies that we have developed, and are improving at 
        Veratect.
    (5) Suggest how Veratect can support NBIC and the National 
        Biosurveillance Integration Mission.
          brief history of biological threats, 1918 to present
    I would like to begin by sharing some historical context as we 
review past and present diseases. In the late 1990's, I worked with the 
World Health Organization and NASA to examine environmental and 
climatic phenomena in Africa potentially associated with the emergence 
of the Ebola virus. This work led to the first model for rapid 
identification of ``conditions favorable'' for Ebola epidemics using 
satellite imagery. It was during this time period that WHO and its 
partners initiated the Global Outbreak Alert and Response Network 
(GOARN), the Canadians created the Global Public Health Intelligence 
Network (GPHIN), and ProMED was started; indeed it was the birth of 
what we would later refer to as a new professional discipline in 
monitoring publicly available global information.
    In 2003, several colleagues and I applied this idea to West Nile 
virus, utilizing the concept of ``graded alerting'' married to ``graded 
response'', where clues of the emergence of a biological event 
sensitize a network of biosurveillance analysts to begin actively 
searching for more information that may ultimately yield a response 
action. That work evolved into the National Library of Medicine (NLM)-
sponsored Project Sentinel, which examined the role of syndromic 
surveillance in biodefense. The most substantial realization of Project 
Sentinel was the possibility of connecting a global biosurveillance 
system seamlessly to hospitals in America using information technology 
so that patients would not be seen by American healthcare workers 
without access to immediate situational awareness of what that patient 
might have been exposed to while traveling overseas. This was a 
poignant note when considering the vulnerability of Toronto's hospitals 
in 2003 when they unknowingly admitted suspect and confirmed cases of 
SARS that prompted quarantine and closure of their facilities.
    One of the things that history is teaching us now is that, in the 
context of influenza season, the impact on the medical grid is 
considered substantial, but brief. However, in the case of a pandemic, 
the possibility of a ``medical blackout'' becomes a serious 
consideration. America's hospitals are not linked to near real-time 
situational awareness, which is a serious issue given biological 
hazards can easily translocate undetected and un-forewarned in hours 
through the air traffic grid from Africa to New York and Asia to Los 
Angeles.
    Clearly, globalization and more specifically the transportation 
grid (as it has become more developed) has heightened the risk of 
transnational spread of disease. Just last week we saw a case of 
Marburg hemorrhagic fever transferred by flight from Uganda to the 
Netherlands. Currently, the United States is experiencing the worst 
measles epidemic in 10 years, which has spread to 15 States thanks to 
foreign introduction by returning travelers to the United States. Of 
course, the Members are aware of the current national salmonella food 
contamination event that CDC and FDA are struggling to investigate, 
courtesy of our globalized commerce.
    According to the U.S. Department of Transportation, the total bi-
directional exchange of direct, non-stop air traffic between the United 
States and the rest of the world was 81.4 million passengers in 1990. 
By 2005, bi-directional air traffic between the United States and the 
rest of the world increased by 182 percent to 148.6 million. In 1990, 
bi-directional exchange between China and the United States was 84,308 
passengers with 3 Chinese cities connecting to 7 U.S. cities. By 2005, 
this had increased to 1.5 million passengers, which is an increase of 
1,819 percent with 9 Chinese cities connecting to 27 U.S. cities.
    It is obvious that international air traffic to and from the United 
States is steadily increasing. However, translocation of disease by 
aircraft has been reported with community exposures. Historically, the 
influenza pandemics of 1918, 1957 and 1968 and the HIV/AIDS pandemic 
were brought to the United States through transoceanic ships and 
airplanes. Pathogens such as adenovirus, Chikungunya virus, the cholera 
bacterium, dengue virus, Ebola and Margburg hemorrhagic fever viruses, 
hepatitis A virus, human metapneumovirus, legionella bacterium, the 
malaria parasite, measles virus, mycoplasma bacterium, norovirus, 
parainfluenza virus, respiratory syncytial virus, rhinovirus, 
salmonella bacterium, SARS-coronavirus, both seasonal and pandemic 
influenza virus, shigella bacterium, smallpox virus (historically), 
treatable tuberculosis as well as Multi-Drug Resistant (MDR-TB) and 
Extensively Drug Resistant (XDR-TB) forms of the bacteria, West Nile 
virus, and yellow fever virus have all been documented to have been 
vectored by aircraft.
    But no historical review of disease threats would be complete 
without some understanding of the 1918 Spanish influenza-H1N1, which 
infected one-third of the world's 1.5 billion citizens and killed over 
50 million of them. This pandemic took almost a year to spread from its 
origin to full global involvement. A contemporary 1918-like public 
health disaster could kill 1.9 million Americans and spread by 
passenger jets in as little as 3 to 4 weeks from source to global 
involvement. Our team has serious concerns that such an event may 
result in sustained ``medical blackouts'', critical infrastructure 
failures and acute, overwhelming socioeconomic social disruption. 
Further, economic research suggests a possible 8- to 10-year global 
economic depression in a multi-trillion cost to the world economy. Such 
a scenario would have serious implications for our ability to project 
our military might, maintain our homeland security, and our national 
security, economy and society.
    So where are we today--what have we done?
    The United States stands at ever-present and increasing risk for 
further introductions of exotic infectious disease with potentially 
serious consequences to the Nation. From my perspective in a near real-
time operations environment (which will be described below), we have 
hours or at most a few days to respond to an emergent threat. In other 
words, while consideration of intentional release or bioterrorism is 
important and key to national security, naturally occurring threats are 
more likely and have occurred regularly throughout history. Time-
sensitive public health response is the best counter measure we have 
for both. Early detection is the key to early response and early 
containment.
    My initial work to anticipate the emergence of Ebola, explore 
graded surveillance for West Nile Virus and connectivity to hospital-
based disease surveillance made evident the significant limitations of 
situational awareness relating to emerging global biological threats 
among our medical, veterinary, public health, and homeland security 
communities. We concluded that, particularly with regard to highly 
communicable diseases, there was a critical need for identifying the 
earliest possible indications and warnings of foreign biological 
threats to enhance our ability to proactively implement effective 
countermeasures. Again, early detection coupled with early response 
means early control.
    From 2004 to 2005, I volunteered my services as the Biodefense 
Technical Advisor of the U.S. Army Medical Research and Material 
Command's Telemedicine and Advanced Technology Research Center 
(USAMRMC-TATRC) to serve as a member of the National Biosurveillance 
Integration System (NBIS) Concept Design Review panel. In late 2005, I 
actively canvassed the Department of Homeland Security and the Homeland 
Security Council to assist with the operational activation of the 
National Biosurveillance Integration Center (NBIC). As its first Chief 
of Operations, and in conjunction with the talented people on the NBIC 
team, we drafted the first concept of operation.
    Except for BioWatch, we did not have access to operationally 
relevant biosurveillance information, because it simply did not exist 
at that point. While at DHS-NBIC, I interacted with representatives of 
Customs and Border Patrol, Immigrations and Customs Enforcement, the 
Transportation Security Administration, and the U.S. Coast Guard who 
all told me stories of passengers and immigrants who presented with 
illness at the border. It was my impression that the coordination of 
situational awareness for these issues with CDC's Division of 
Quarantine and Population Migration would be a powerful adjunct within 
NBIC's mission of biosurveillance. It was in these early days we 
realized the need for a novel professional analytic discipline for 
integrated biosurveillance. With time, we came to understand that 
additional funding in a different setting was essential to develop the 
analytical methodology and discipline that would be so crucial to this 
historically unprecedented capability.
    Up to this point, NBIC had configured itself operationally in the 
manner of a military operations center not unlike the North American 
Aerospace Defense Command (NORAD). This included mission analysis, 
concept of operations and an operations plan that was implemented using 
information feeds from sources such as BioWatch, BioSense, Argus 
(further addressed below) and other sources of information. This was a 
historically unique operations center in my opinion in that we were now 
beginning to function with integrated and prioritized reporting 
requirements across the Federal agencies. Unfortunately, the structure 
of the program was not optimal for its Federal partners because it 
needed to be established in a neutral environment that brought Federal 
agencies together as equals.
    After my departure, NBIC focused heavily on building formal 
relationships with the Federal community. I did not see much support 
for detection subsystems nor substantive improvement in their early 
warning capability. I found there to be limited operational, routine, 
near real-time engagement between NBIC, their Federal partners and 
State and local authorities. However, NBIC's continued participation as 
a member of the Biosurveillance Indication and Warning Analysis 
Community (BIWAC) was an excellent step in the right direction. I will 
explain BIWAC in more detail below. It is my opinion the formal 
relationships needed for NBIC's success will take years to develop, 
meanwhile the threat space continues to increase in complexity.
         response to date, the creation of the argus prototype
    Due in part to the emergence of SARS in southern China in 2002 and 
2003 and the recent Highly Pathogenic Avian Influenza-H5N1 pandemic 
concern, DHS and the Intelligence Technology Innovation Center (ITIC) 
supported the activation of Project Argus in late 2004. Project Argus 
was established as a prototype research effort to explore the use of 
indicators to detect and track biological events, crises and disasters. 
I served as the Principal Investigator while serving as a faculty 
member of the Division of Infectious Disease, Department of Pediatrics, 
Georgetown University Medical Center. It was during the research and 
development phase of Argus that I also volunteered by services to the 
NBIS Concept Design review and later as the first Chief of Operations 
of the NBIC. Therefore, the design of both NBIC and the Argus prototype 
became synergistic.
    While at Georgetown University (we were housed at GU for 
convenience with little interaction with the rest of campus and no 
independent support from the university), we applied established proven 
methodologies to what would become a new analytic and professional 
discipline in biological event detection and tracking with a full time 
staff of cultural and linguistic and subject matter experts and 
analysts based upon state-of-the-art technology provided by the MITRE 
Corporation. The approach is based on one of the recommendations of the 
9/11 Commission to collect, analyze and correlate data from the world 
wide web as a source for information about indicators of social 
disruption caused by illness and disease. Although simple in concept it 
was an extremely complex system. The sponsors of our work deserve the 
Nation's thanks for having the courage to back our idea--which in 
retrospect is one of the most powerful national security ideas to have 
emerged from the post-9/11 period. We benefited from the enthusiastic 
intellectual support of many parts of the U.S. Government including 
CDC, USDA, DoD combatant commands around the world, and many others.
    In 2006, Congress supported activation of the Argus Research 
Operations Center, which was to be a prototype operations center for 
infectious disease event detection and tracking based on the 
methodology that we developed. Our mission was to monitor the world for 
the emergence and spread of H5N1 Avian Influenza. We later voluntarily 
expanded this mission to include 140 diseases the effect both animals 
and humans globally at no additional cost to the Federal Government.
    At this point I became Chief of the Argus Research Operations 
Center (AROC), but remained in strong support of NBIC and the National 
Biosurveillance Integration mission. It was my opinion that NBIC would 
not be able to achieve its objectives without an adequate detection 
subsystem; therefore I chose to focus my efforts on Argus and support 
NBIC from Argus.
    At our peak capacity, we estimated we were accessing over a million 
pieces of open source information daily covering every country in the 
world (except the United States) that resulted in the production of, on 
average, 200 reports per day. Using a disease event warning system 
modeled after NOAA's National Weather Service, we issued Warnings, 
Watches, and Advisories in accordance with guidelines agreed upon by 
our research partners in the Federal Government. On average, we 
maintained 15 Advisories, 5 Watches, and 2 Warnings active on our 
Watchboard at any given time, with 2,200 individual case files of 
socially disruptive biological events maintained and monitored daily in 
over 170 countries involving 130 disease entities affecting humans or 
animals. We reached a maximum load of 3,300 individual case files 
maintained and monitored daily during the winter of 2007.
    This information, as provided to our mostly Federal user community, 
sensitized them to be vigilant for the most concerning biological 
events in the world; this vigilance occasionally resulted in proactive 
requests for more information by our partners such as CDC and USDA. 
This in turn, contributed to the United States' participation in the 
International Health Regulations through proactive information sharing 
with WHO and our international partners. Since the program had begun, 
we logged over 30,000 biological events in varying stages of social 
disruption throughout the world involving pathogens such as H5N1 avian 
influenza, other influenza strains, Ebola virus, cholera, and other 
exotic pathogens. Of note, while the majority of these events were 
naturally occurring, this capability identified several laboratory 
accidents and occasionally allegations of intentional use of biological 
agents.
    Upon invitation by CDC, we presented the results of our efforts to 
the G8 Health Security Advisory Group in February 2008. To the best of 
our knowledge, our approach achieved unprecedented operational 
milestones in comparison to the leading global biological event 
detection and tracking systems such as ProMED, the Global Public Health 
Intelligence Network (GPHIN), HealthMap and MedISys. One of the key 
observations by the G8 members was a unanimous desire for there to be a 
human interface between the raw data and elicited warning information; 
there was strong support for nurturing a new professional discipline 
devoted to near real time operational biosurveillance.
    The following examples highlight some of our achievements:
   The operations team at Argus, the majority of whom are now 
        working for Veratect, served the country as the lead tactical 
        global event detection team for H5N1 avian influenza and were 
        the first group in the world to detect the expansion of H5N1 
        from southern China to Russia and then Eastern Europe. During 
        the winter of 2007, we filed over 12,000 reports of events 
        possibly related to H5N1 avian influenza.
   In late 2004 and early 2005, we participated in the tsunami 
        response by providing daily situational awareness reports to 
        humanitarian responders. In commenting on our operations, the 
        U.S. Pacific Command wrote, ``Information is power only when 
        it's shared. The situational awareness that portions of Argus 
        provided during tsunami relief efforts was an impressive 
        attention step. We see some tremendous opportunities and value 
        added for this capability within our area of operational 
        responsibility, which literally covers half the globe. Thanks 
        for keeping our situational awareness up during difficult 
        times.''
   On August 3, 2007, this team was the first to notify the 
        U.S. Government of undiagnosed vesicular disease in cattle in 
        Surrey, United Kingdom that later was diagnosed as hoof-and-
        mouth disease (FMD). Of additional interest, this event was 
        later found to be the result of a laboratory accident, and 
        intentional release was explored as a possible etiology but 
        later discounted. The Members may recall the tremendous 
        economic damage observed during the last epidemic of FMD in the 
        United Kingdom in 2001.
   On August 27, 2007, we were the first to report indications 
        of the Ebola epidemic in Kasai, Democratic Republic of the 
        Congo. This information was made available immediately to CDC, 
        and other members of the Federal user community. CDC's 
        collaboration in rapid access to ground verification 
        information through its partnership with WHO and other 
        international partners was impressive, as it highlighted the 
        potential reduction of the time between initial event detection 
        to ground verification to hours and days as opposed to weeks or 
        months. Again, early detection plus early response equals 
        containment.
                           h3n2 vaccine drift
    Influenza kills an estimated 250,000 to 500,000 people globally 
each year. While monitoring the current pandemic threat of H5N1 avian 
influenza, the team also monitored all influenza strains in support of 
global influenza disease monitoring. During the winter of 2006 and 
2007, the team issued nearly 3,000 event reports across 128 countries 
and 27 languages, which included 181 Advisories, 58 Watches, and 38 
Warnings. Our team identified hundreds of reports of a type A/H3N2 
influenza virus that appeared to have drifted away from the current 
vaccine strain of H3N2 beginning in early January 2007 in Beijing, 
China, 6 weeks prior to the WHO Consultation on the Composition of 
Influenza Vaccine for the Northern Hemisphere. We later found similar 
reports in a multitude of countries and collaboratively worked with CDC 
to track this important finding. The value of this information was 
validated when the World Health Organization and its partners 
recommended a change in the southern hemisphere influenza vaccine to 
include an updated H3N2 strain.
    The most important lesson from the H3N2 vaccine failure is not just 
the need for a robust comprehensive early detection system, but open 
and ongoing information exchange between Government agencies and other 
global health organizations. The lack of transparency to the vaccine 
development process has resulted in unnecessary deaths here in the 
United States.
    During the subsequent 2007 and 2008 influenza season in the United 
States, the northern hemisphere vaccine for the type A/H3N2 virus 
provided suboptimal coverage at 58 percent effectiveness. This does not 
mean the vaccine was not helpful in terms of reducing the severity and 
burden of disease. However, although the vaccine achieved some degree 
of coverage, it was less effective than vaccines used in previous years 
due to the strain mismatch. The 2007 and 2008 influenza season was 
severe, with pneumonia and influenza-related mortality above epidemic 
threshold for 19 consecutive weeks compared to an 11 consecutive week 
maximum documented in the prior three seasons. This represents a 170 
percent increase in seasonal deaths seen since the 2004 and 2005 
season. Forty-nine States ultimately reported widespread transmission. 
In February, one physician commented in ProMED, ``I have not seen in my 
30 years of practice such a relatively large number of patients 
presenting with documented influenza vaccine `failure'.''
                     shortcomings of the prototype
    Unfortunately, by operational design, the prototype was not able to 
monitor what occurred with that strain of influenza here within the 
United States. From CDC, we learned that there had been an increase in 
H3N2 clustered initially around regions of the United States connected 
directly to China by international air flights. Later laboratory 
reports from CDC indicated this virus had drifted away from the 
existing vaccine strain. We noted that the very same week we became 
concerned about reports in Beijing of an unusual strain of H3N2, 
vaccine-drifted H3N2 isolates were reported in U.S. cities connected to 
Beijing by direct air traffic. We did the best we could do with the 
prototype, but it was not adequate. If precise surveillance of 
influenza ``hot spots'' was acted upon with vigorous sampling, we 
believe history might have been different.
    Let's be clear here. As illustrated in the July 10, 2008 issue of 
Nature magazine, the northern hemisphere, including the United States, 
missed an opportunity for anticipating a bad season of influenza 
because: (1) Information was not used proactively to acquire influenza 
samples from suspicious event/areas in the world, and (2) our most 
mission critical surveillance was blinded at home. This was one of the 
biggest difficulties with the prior system as it was set up at 
Georgetown.
                       nbic mandate and the biwac
    For NBIC to successfully execute its mission, it needs to leverage 
the experience of its Federal partners. One of the early examples of 
this was the working relationship of NBIC and BIWAC.
    To facilitate operational validation, my colleagues and I initiated 
the creation of the unofficial, Federal Biological Indication and 
Warning Analysis Community (BIWAC). As mentioned above, it was BIWAC 
that reviewed our reporting requirements with us on a quarterly basis 
to ensure proper product alignment with the user. BIWAC currently 
includes CDC's Global Disease Detection team; USDA's Centers for 
Epidemiology and Animal Health (CEAH); DHS' National Biosurveillance 
Integration Center; the Armed Forces Medical Intelligence Center; other 
Intelligence Community organizations; the Defense Threat Reduction 
Agency; and the U.S. Strategic Command Center for Combating Weapons of 
Mass Destruction.
    The BIWAC created a central clearing base where each member 
contributed what he or she knew about emerging disease and to quickly 
determine coordinated next steps that included event verification and, 
in some cases, actual ground response. To enhance this process, we 
activated Project Wildfire, which was an experimental information 
sharing system that enabled near-real time, unclassified dialog among 
the BIWAC partners. Wildfire, although experimental, attracted a 
substantial amount of Federal use; for the first time, we saw the power 
of the National Biosurveillance Integration Mission in the daily 
activities of the BIWAC.
    The success of BIWAC and the Wildfire experiment was tempered by 
the observation that ground verification of biological event 
information was severely limited both in terms of types of disease 
covered as well as geographic coverage. We realized that the 
actionability of the information was therefore impaired without near 
real-time interaction with such international partners as NGO's (who 
are often on the front lines as diseases emerge) and U.N. 
organizations. One key implication was a requirement for a near real-
time functioning global network. Another implication was the 
realization that there will be times when we will be unable to verify 
warning information in the face of daily, nonstop air traffic. A recent 
example of this would be SARS in 2003, where by the time a global alert 
was issued, the disease was already present in eight countries, 
including the United States.
    The committee is already familiar with the fact SARS was present in 
China many months before WHO awareness and the Global Alert was not 
issued until eight countries (including the United States) were already 
affected. It took 4 months to interrupt all chains of transmission that 
ultimately affected 27 countries on all continents except Antarctica. I 
would point out the same phenomena has occurred in the past including 
the 1957 and 1968 pandemics. Local authorities in Hong Kong reported 
unusual respiratory disease that inundated multiple urban sectors of 
their city nearly a month in advance of WHO's public acknowledgement of 
a global threat referred to as a ``pandemic''. By then the disease was 
already in the air traffic grid.
    I will note here there was evidence in both pandemics that Mainland 
Chinese public reporting of unusual respiratory disease preceded 
reporting in Hong Kong by at least several weeks. In summary, the 1957 
and 1968 pandemics and 2002-2003 SARS all were reported at the local 
level well in advance of national Ministries of Health and WHO 
awareness or the issuance of a warning to the world. Again, near-real 
time global disease detection and tracking is essential for our Nation.
               veratect and the future of biosurveillance
    The Argus program, although a successful prototype, had two 
critical flaws. First, we were unable to extend our process to include 
domestic biological event detection and tracking. Second, we were 
unable to build global partnerships with organizations whose missions 
could be greatly enhanced with this information. This was concerning as 
we realized other natural hazard warning systems such as tornado 
forecasting in the 1950's came under public scrutiny and criticism when 
it was discovered that a successful forecast of a deadly tornado was 
not shared by the military with the local community that received the 
onslaught of the storm. What was more important was not the high false-
positive rate but that a successful forecast could have provided hours 
of lifesaving warning beforehand. We saw the Argus program coming under 
similar scrutiny some day; our team felt we had an ethical and moral 
responsibility to address this concern.
    Because of these mission-crippling limitations, all the founding 
members and many of the most skilled analysts from the original Argus 
team decided to leave the prototype program and begin anew in a private 
industry environment, the Veratect Corporation.
    Veratect's mission is to provide the earliest detection of threats 
to human, plant and animal life while empowering corporations, 
Government organizations, NGO's and global citizens with trusted and 
actionable information.
    Our domestic capabilities and global partnerships, together with 
Veratect's new ForeShadowTM operating environment and 
VeraSightTM interface represent a significant step forward 
in the early detection and 247 tracking of biological events that 
empowers early warning and response from a broad range of private and 
public stakeholders that share these same risks. Our team of cultural 
and linguist interpreters with deep domain experience in recognizing 
pathogens at their earliest emergence represent 230+ person years of 
international experience and nearly 100 person years of experience in 
this new and proven professional discipline.
    With nearly five times the sources of the prototype, we have an 
estimated coverage of 82 percent of the world's population now, in near 
real time. By the end of 2008, we will have expanded this coverage to 
more then 90 percent. Additionally, we are in discussions to have 
access to more than a quarter-million correspondents on the ground 
globally to support near real-time ground truth verification. We stand 
ready to not only meet the needs of DHS and other Federal agencies, but 
also local, tribal, and territorial governments in all 50 States. We 
currently monitor over 200 diseases that affect humans or animals, and 
our methodology is being expanded to include monitoring for biothreats 
to food security and crop disease.
    For this approach to be successful, there is an absolute 
requirement for human analysts who serve as the intermediary between 
the raw data and the interface with those who may take further action 
like CDC or USDA. Having a close relationship with these users ensures 
we maintain a proper level of sensitivity and specificity, as well as 
conduct continual quality assurance and reviews of our standard 
operating procedures. This distinguishes our efforts from that of other 
systems that produce raw data outputs such as HealthMap. As mentioned 
earlier, the G8 Health Security Advisory Group, it was clear the G8 
members were more interested in humans serving as an interface with the 
data versus being shown raw, unmediated data outputs.
                 veratect, nbic and the global mission
    The team at Veratect has a unique perspective of what NBIC should 
do to meet the congressionally mandated mission objectives. Members of 
our team at Veratect have worked closely with DHS-NBIC from the very 
beginning. For the last 2 years, our team has been an important source 
of information for the entire Federal Government in the support of our 
Nation's biosecurity.
    NBIC is chartered to collect and consolidate near-real time 
information on biological events using in part, resources within the 
Federal Government and make those consolidated resources available to 
the Federal user community charged with meeting biological threats.
    We believe in this mission, and we look forward to working with 
DHS-NBIC again, and this time with far greater resources and 
capabilities. Veratect has offered to provide our analytical early 
warning system to NBIC and protect the United States from the threat of 
infectious disease, it should also be noted that this will also provide 
significant benefits to the rest of the world. Disease is the common 
enemy of every human on the planet.
    NBIC's mission (as outlined in HSPD-7, -9, -10; NSPD-33; and Public 
Law 110-53), is a valid and critically needed function for both the 
United States and for the support of our international partners through 
the International Health Regulations, the World Animal Health 
Organization (OIE) Terrestrial Animal Health Code, the Biological 
Weapons Convention, and safety monitoring for biotechnology.
    For the United States, a large number of biological crises and 
disasters are mostly imported events, as exemplified by the 
introductions of HIV/AIDS; West Nile virus; monkeypox; SARS and all 
four of the major influenza pandemics of the past 100 years. Influenza 
pandemics are generally believed to start outside the United States; 
the next pandemic will most likely come from a foreign location. Our 
best defense is based on early detection.
    The current concern of an H5N1 influenza pandemic highlights this 
concern as well. As stated in the 2007 World Health Report, ``It cannot 
be over-emphasized that a truly effective international preparedness 
and response coordination mechanism cannot be managed nationally. 
Global cooperation, collaboration, and investment are necessary to 
ensure a safer future. This means a multi-sectoral approach to managing 
the problem of global disease that includes governments, industry, 
public and private financiers, academia, international organizations 
and civil society, all of whom have responsibilities for building 
global public health security.''
    We can support the role of NBIC to protect our country by 
facilitating early recognition of biological events that may pose 
threats to our Nation's security, food production systems, and 
citizens' well being. The spirit of NBIC's mission may be seen across 
other public emergency warning systems. As with those systems, a 
critical requirement for NBIC is reliance on detection subsystems that 
include not only the information they provide but the subject matter 
expertise behind it.
    Veratect is also able to support a turnkey portal for foreign and 
domestic biological event detection and tracking with extensive ground 
truth validation that can be shared with NBIC's Federal, State and 
local partners. The benefits of immediate access to this portal will 
include access for CDC, USDA, FDA, DOD and other Federal partners who 
can then engage in more effective coordination of disease surveillance 
and response.
    By the nature of our business, we can assist NBIS by working in 
collaboration with other stakeholders in global health including 
transnational corporations, NGO's and friendly foreign governments. 
U.S. corporations are increasingly concerned about how emerging 
diseases might affect their own employees and indigenous workers, 
production partners and supply chains. Foreign corporations operate in 
areas of interest to the United States and include oil, mining, 
manufacturing and food production. Their partnership is key to NBIC's 
mission success.
    We are prepared to support NBIC's implementation of its mission 
objectives by the end of August 2008. Our team and portal is available 
immediately and we stand ready to support a user community that is well 
known to us.
    There is an opportunity for the United States to lead the world by 
example once again. The United States has been the one to lead that 
development of many other societal warning systems over the years. Here 
we can be the leader in supporting implementation of the new 
International Health Regulations along with our international partners. 
We can demonstrate to the world our moral and ethical strength by 
assisting NGO's in saving lives. We can support our domestic industry 
competing in the global marketplace. And most importantly, we can 
finally support our local city, county and State officials in 
biosurveillance. In the end, we are here to ensure the United States 
maintains technical supremacy in global biosurveillance in these 
uncertain times.
    I have three closing comments that speak to where we go from here:
    1. It is in the national and global interest for the NBIC charter 
        to be implemented immediately. This envisioned system will help 
        protect human, animal and plant life, the national food supply 
        and critical infrastructure against the common enemy of 
        disease. The first step is early detection. We are doing that 
        today.
    2. Veratect provides a superset of capabilities, resources and 
        global relationships with private and non-profit organizations 
        that can be of the greatest value to NBIC in meeting its 
        mission. What we do is not reliant upon the NBIC system. We can 
        provide NBIC with a fully operational early disease detection 
        and tracking system today.
    3. The disease risks are real and we are on borrowed time. We are 
        fortunate that the SARS epidemic and this year's H3N2 vaccine 
        mismatch were not more disruptive. And we remain very much 
        exposed to an influenza pandemic. My colleagues and I at 
        Veratect are eager and ready to support the national mission 
        today.
    I would like to thank the visionaries in the Federal Government and 
Congress who supported the research and development that led us to this 
point, the courageous men and women of the BIWAC for their partnership 
and the Veratect team for their hard work in operationalizing this 
critically important national asset. While none of us feel that we are, 
as a Nation, where we need to be in terms of addressing the risks I 
have covered here today, I believe that Veratect can uniquely assist 
NBIC in rapidly achieving its goals.
    Once again, I am grateful for this opportunity to testify, and I 
stand ready to answer any questions you might have.
    Thank you.

    Mr. Langevin. Thank you, Mr. Wilson.
    I want to thank all of the witnesses for their testimony, 
and I will remind each Member that they will have 5 minutes to 
question the panel.
    Now I recognize myself for questions.
    Before I do that, I am going to ask unanimous consent that 
the testimony for the record from Dr. David Hartley from the 
Global Argus Project be submitted for the record.
    Without objection, so ordered.
    [The statement of Dr. Hartley follows:]
                  Prepared Statement of David Hartley
                             July 18, 2008
    Chairman Langevin, Ranking Member McCaul, and other Members of the 
subcommittee, please accept my thanks on behalf of the Global Argus 
team at Georgetown University Medical Center for this opportunity to 
update you on our work in the context of your hearing on the status of 
implementing bio-surveillance requirements of the 9/11 Act.
    Project Argus is a prototype bio-surveillance system pioneered at 
Georgetown University which was initiated in 2004 with funding support 
from the Intelligence Technology Innovation Center (ITIC) and is today 
supported by the Defense Threat Reduction Agency (DTRA) and the Open 
Source Center (OSC) of the Office of the Director of National 
Intelligence (ODNI). Argus is designed to detect and track foreign 
biological events that may threaten human, plant, and animal health 
globally and in the United States by monitoring social disruption 
evident in local, native-language media reports around the world. 
Because of our funding source, the data collection focuses on sources 
outside our country.
    By monitoring media sources--ranging from traditional print and 
electronic media outlets to internet-based newsletters in approximately 
40 languages on every continent, save Antarctica--we have developed a 
solid prototype for gathering indications and warnings which serves an 
important cueing function. (A list of the languages covered by Argus as 
of last month is attached for your information.) It alerts users to 
events that may signal the initiation of outbreaks and show 
trajectories of events that may require additional investigation. To 
give you a sense of the kinds of reports that Argus generates, let me 
share two recent examples:
   On June 13, 2008, Argus reported on a child in Vietnam 
        hospitalized with respiratory distress following eating duck 
        form the family's farm. The illness was suggestive of H5N1 
        infection. The provision of this information by the CDC to the 
        Vietnamese Ministry of Health proved to be very helpful to 
        their epidemiology office.
   On July 7--just last week--Argus alerted a Federal user 
        about a suspected case of H5N1 avian influenza in Egypt. This 
        user alerted an AI response team on the ground, which was 
        otherwise unaware of the situation.
    Both of those instances and the manner in which they were handled 
recognize the fact that Argus cannot and does not purport to determine 
whether or what type of action should be taken. Instead, our activity 
serves to provide timely information to governmental officials to 
inform their decisionmaking. We are proud that Argus provides an 
important and unique data stream to the National Bio-surveillance 
Integration System (NBIS), complementing the reports of various Federal 
agencies with information gathered from open source media. We have been 
encouraged by the favorable comments from NBIS personnel about the 
value they find in the product generated by Argus.
    In developing the Argus prototype, Georgetown University 
researchers have developed a taxonomy of direct and indirect indicators 
of outbreak activity based on:
   Environmental and ecological conditions;
   Reports of disease activity; and,
   Markers of social disruption such as school closings and 
        infrastructure overloads.
    Forty analysts fluent in the languages I referenced earlier are 
coupled with machine translation capabilities covering 13 languages to 
ensure a broad and deep scope to the media monitoring activities. 
Bayesian analysis tools are utilized for article selection and 
alerting. Approximately 1,000,000 articles are scanned daily with 25 
percent of those being archived. Since the inception of the program, 
the Argus archive has grown to over 128,000,000 articles.
    Over 40 Federal, State and local governmental entities use Argus on 
a daily basis including the Departments of Homeland Security, Health 
and Human Services, and State as well as the funding agencies. State 
and local governmental organizations in New York and Colorado as well 
as Colorado State, Kansas State, Syracuse, and Yale Universities are 
among the regular Argus Watchboard users.
    Global Argus underwent a change in leadership in April of this 
year. Such transitions certainly present challenges, but they also 
offer opportunities for strengthening projects such as this. I am 
pleased to be able to report that we have effectively managed the 
transition, including some personnel changes, without disrupting the 
quality or timeliness of the reports generated by Argus. In fact, since 
the change in leadership, Argus has increased the number of languages 
covered by qualified analysts and is in the process of adding even 
greater language capabilities.
    Having said that, working closely with the COTRs for the project, 
we are focusing on areas of focus designed to strengthen and perfect 
the prototype to ready it for eventual commercial utilization. I would 
emphasize that, while we are immensely proud of what has been achieved 
to date, we also share the interest of our current funding agencies in 
ensuring that Argus is fully ready to the task before it is scaled up. 
The areas on which we are actively engaged at present aim to validate 
taxonomies, methods and protocols including:
   Reliable statistical characterization of Argus system 
        performance;
   Better documentation and validation of methodologies; and
   Defining operational procedures set out in manuals both for 
        the operational team and for various types of users.
    With Argus operational in its current configuration at Georgetown 
and with those validation and refinement efforts underway, I am 
confident that we, operating within an academic research institution 
with highly qualified scientific, medical and linguistic talent readily 
at hand, are ideally positioned to continue and broaden the project's 
ability to generate accurate and timely reports while also conducting 
the validation and refinement work to ensure that the system is 
commensurate to the task which we all want to have achieved. We have 
had the depth of experience of developing Argus to its current stage 
and managing its operations to date, and we now have the benefit of a 
strengthened team of analysts to address the improvements sought by the 
Government agencies who have become particularly familiar with the 
system.
    On occasion, we have been asked about ``next steps'' for Argus, and 
the obvious need--beyond those referenced earlier--is to complement the 
international monitoring of these media-based indicators of social 
disruption with a similar capability domestically. As I referenced 
earlier, that is not possible given the current funding source, but, 
with appropriate funding, we stand ready to move on that front in a 
fashion that will benefit from the enhancements we are currently 
developing.
              argus foreign language coverage--june, 2008
Team Europe
    Albanian
    Bosnian
    Bulgarian
    Croatian
    Czech
    French
    German
    Greek
    Italian
    Macedonian
    Polish
    Portuguese
    Romanian
    Serbian
    Slovak
    Spanish
Team Central Asia
    Russian
    Ukrainian
    Belorussian
    Mongolian
    Georgian
    Uzbek
    Azeri
    Turkish
    Kyrgy
Team East Asia
    Japanese
    Chinese (Mandarin and Cantonese)
    Korean
Team Southeast Asia
    Thai
    Malay
    Vietnamese
    Indonesian
Team Middle East
    Arabic
    Tajik
    Farsi
    Dari
Team Latin America
    Spanish
    Portuguese
Team Africa
    Berber
    Arabic
    French

    Mr. Langevin. To Mr. Myers and Mr. Hooks, the 9/11 Act 
requires that the National Biosurveillance Integration Center, 
NBIC, under Section 316 of the Homeland Security Act be fully 
operational by not later than September 30, 2008.
    Again, from our meetings with NBIC's staff, a fully 
functioning NBIC, including full participation by local 
authorities and private sector partners, are at least 2 years 
off. Is that accurate? Can you speak to how soon before it will 
be fully functional? It seems to us that right now really NBIC 
is running in a sort of test mode and is not really being used 
even by the perspective member agencies.
    So can you give us a current status of NBIC, most 
especially how far off are we before it is in fact going to be 
fully functional? What are the problems? What is standing in 
the way of us getting to the point where it is fully 
functioning?
    If we can start with Mr. Myers or Mr. Hooks.
    Mr. Hooks. Thank you, Mr. Chairman.
    As you know, following the implementation of the 9/11 Act, 
which set clearly the vision and mission space forward for the 
NBIC, the NBIC started producing products last October into the 
interagency working group community. On 30 March of this year, 
we went live with the IT system, the NBIS 2.0, as well as the 
biological common operating picture, and at that point, we had 
an increased capability to share information in the interagency 
through that IT platform.
    From that time, we have been operational. When we talk 
about being in a fully operational state by 30 September, we 
have identified, what are the different goals to reach that 
fully operational state? We have provided those seven different 
goals.
    But to summarize and highlight that, that means that we 
have the key personnel in place on the Federal staff as well as 
10 detailees on board from different interagency components; 
that we have the facilities in a condition that they are 
providing strong analytical support to our people; as well as 
an appropriate outyear funding profile for the NBIC operations, 
so it is very clear what the expectations and what are funding 
are as well.
    Within the IT system, we have been identifying the 
functionality goals, specifically additional capability within 
that system to be able to share information, to improve the 
analytics, as well as a system backup capability and a 
contingency operations plan. We are making updates to the 
biological common operating picture and are providing improved 
situational reporting to the different interagency members.
    Continuing on, in fact, with those goals, we are developing 
a more robust interagency community. We intend to have the 
memorandums of understanding in place, the interagency 
agreements in place for those detailees to strengthen. We will 
have held our NBIS interagency oversight council meeting this 
August, and we are on a path to have better cooperation and 
agreement with the government coordinating councils and sector 
coordinating councils that are run out of the Office of 
Infrastructure Protection.
    We also are strengthening the interagency collaboration; 
that is one of our goals, to be at full operational capability 
within DHS. We will have a 5-year strategic plan developed by 
that point.
    Those are our goals. There are huge challenges to reach 
those. The probably largest challenge is to create that trusted 
environment of information sharing within the Federal 
Government. In my previous position in Science and Technology 
Directorate, bringing together the 23 agencies to develop high-
priority technology needs, I was able to do that in a 3-month 
period for the first draft of that and then ran that program 
for 2 years. That was easier than bringing the 12 member 
agencies together in a trusted information-sharing environment. 
We have seen that as a real challenge, but we have made 
progress as we have worked through the current tomato 
salmonella event that is ongoing. We will go into details of 
that as you would like.
    Mr. Langevin. Let me stop you there, Because in your 
testimony, in your answer just now, you talked about having 10 
detailees by September 30. How exactly are you going to be able 
to accomplish that? Is that realistic, when I thought right now 
you only had one detailee from CDC? How realistic is bringing 
on the additional number and really completing that goal by 
September 30?
    Mr. Hooks. I think that is a realistic goal. Eric Myers and 
I have looked at that across the 12 member agencies and their 
commitment. On May 23, Secretary Chertoff issued a letter to 
his other Cabinet peers requesting they provide detailees to 
the NBIC operation. Eric has met with those different agencies. 
We have gauged the response from that. We are working the final 
efforts with some of those agencies now. In fact, recently one 
of the agencies said they wanted to bring over two of their 
stronger analytic people to understand the NBIC operations so 
that they can work to understand what are the best complement 
of people in the long term.
    Mr. Langevin. We are going to follow up on that and 
hopefully can hold you to it.
    Mr. Myers, since you are the program manager, would you 
comment on where we are? Do you have additional things to add 
to the testimony of Secretary Hooks?
    Mr. Myers. Thank you, sir.
    Yes, just a couple of things to add to the spice. One is 
the sense that we are in fact operating. We sat down, using a 
previous study and also looking at the memberships. If you look 
at the 12 organizations, they are not only the traditional 
health and health-related organizations, but some that are not 
so related, Department of Commerce, Department of 
Transportation, Department of Interior, Postal System. So there 
are some very important partners in there who are trying to get 
into this culture.
    We in fact have been operating and in fact started to go 
back into operational production last October, as was 
mentioned. We brought in a new cadre of U.S. Public Health 
Service officers to actually man up our watch to give us 24-
hour-a-day sight and vision. This is in the midst of going 
ahead with the execution on two planes: One is the building of 
it to get members. The Department of Agriculture in the first 
week of August will have two members on board with us, which is 
the next two detailees, and they actually come in to start work 
with us, in addition to doing a turnover in the first detailee 
from HHS, which is the individual from CDC.
    So, in addition to that, our interagency working group is a 
very vibrant group. There is a lot of analytic exchange. We do 
it on a daily basis. We formalize it in a routine production 
cycle. So that members, although they are not all signed on the 
dotted line on an MOU, are actually participating in any 
exchange. There has been very rigorous exchange on that. The 
salmonella and tomato risk happens to be one of those events.
    In addition to that, it is not just the inward look, and my 
second point to you, of the NBIC, in the NBIS, into the group 
that we have identified. Of particular importance in there is 
that each of the agencies comes to the table needing to support 
basically two cadres of customers. One is the decision-makers, 
sort of the policymakers. But the other is that we all have are 
operating components. So, for example, DHS has seven operating 
components. So our products are going to those.
    The other aspect that the NBIC brings that is very 
important is the taking of this health and health surveillance 
data that Dr. Wilson I think eloquently stated and 
superimposing that on top of how the Nation operates, the 
critical infrastructures. That becomes exceptionally important 
in terms of getting to early warning. It is not just the 
disease. It is not just a health issue. It is not just the 
population. But it is, what are the structures that that 
impacts, whether that be in food and agriculture, in health and 
finance, et cetera?
    Mr. Langevin. So what operations by September 30 will the 
NBIC center be capable of carrying out? Let's look at that. 
Then I am going to ask Mr. Jenkins to respond, if he would, to 
Mr. Hooks and Mr. Myers, to give your assessment in a point-
counterpoint sort of way. Are they on track? Where are they 
perhaps being overly optimistic? So if you can answer that 
question of the capabilities that are going to be capable to 
carry out.
    Mr. Hooks. So the capabilities that we will be able to 
carry out by September 30 are to continue to monitor worldwide 
different biosurveillance activity, looking for cueing 
opportunities and forward-looking opportunities by integrating 
information from the different partner agencies that they are 
bringing into the NBIC team. We expect to be able to provide 
quality analytical capability back out to our partner agencies, 
who are also feeding that information down into the State and 
local network, so that we will have a common picture that is 
available for the interagency community in the biosurveillance 
arena.
    Mr. Langevin. Mr. Jenkins or Mr. Myers, did you have 
anything to add for that?
    Mr. Myers. No, sir. For the sake of time, that is good.
    Mr. Langevin. Mr. Jenkins.
    Mr. Jenkins. Well, I think with regard to the interagency 
agreements and the detailees, it is not quite clear. The 
current MOUs were signed in January 2007. So between 2007 and 
now, there haven't been any additional MOUs signed. So this 
is--either there is something breaking in the dam, or it is a 
fairly ambitious schedule in the sense that something is 
happening that will get these people to sign these agreement. 
But they also need to have these interagency agreements signed 
for those detailees, because that specifies whether or not they 
are going to be reimbursed, how they will come, what they will 
do, the staffing, the facilities. It is basically an 
operational agreement. The MOU is, ``I agree to participate.'' 
An interagency agreement is much more an operational agreement, 
which is a little more difficult to negotiate simply because it 
has more details that have to be structured.
    So I think, from our perspective, we wish them luck. I hope 
they are right. I hope they achieve it. But I think it may be a 
little bit optimistic.
    Mr. Langevin. Thank you, gentlemen, for your testimony and 
for your answers.
    With that, I now recognize the Ranking Member for 
questions.
    Mr. McCaul. Thank you, Mr. Chairman.
    The Chairman brought up the point of the 9/11 Act being 
fully operational by September 30. It is not defined in the 
statute what ``fully operational'' means.
    Mr. Hooks, what is your definition of ``fully 
operational''?
    Mr. Hooks. Sir, my definition of ``fully operational'' are 
meeting the seven goals that we have laid out with the NBIC 
team and socialized into the interagency NBIC team to provide 
the capability necessary to conduct the mission as defined in 
the 9/11 Act.
    Mr. McCaul. Do you feel confident you will meet that by 
September 30?
    Mr. Hooks. I feel confident that we can meet it if we can 
overcome some big challenges. I mentioned the one, which is the 
interagency cooperation in a trusted information-sharing 
environment.
    I would also like to mention that there is a reprogramming 
request on the Hill right now for $2.2 million. That needs to 
be approved for us to be able to bring the detailees on board 
to provide the IT--to improve the IT system to the capability 
that it needs to reach, as well as to make some space fitout 
improvements so that we can improve that analytical capability.
    Mr. McCaul. So the interagency cooperation, which, granted, 
some of that is out of your control.
    Mr. Hooks. Yes, sir.
    Mr. McCaul. And the appropriation you discussed.
    Mr. Hooks. Yes, sir.
    Mr. McCaul. Mr. Jenkins, you referred to these MOUs that 
had been difficult to enter into. How many different agencies 
have now signed off on MOUs?
    Mr. Jenkins. Six out of 11. There are 12 agencies 
participating, which one is DHS. So the 6 of 11 have signed off 
on them.
    Mr. McCaul. What is the obstacle with the other five 
agencies?
    Mr. Jenkins. Well, part of it, as mentioned by Mr. Myers, 
is that they are nontraditional in the sense that they are 
nontraditional sort of public health agency kind of things. So 
that is part of it. I think the other thing is, in terms of 
that, for example, with regard to the Postal Service, the 
Postal Service is not normally in this kind of environment, 
although they clearly have a very keen interest in early 
biological detection. They are the only Federal agency that has 
actually lost people as a result of a biological event, the 
anthrax attack of 2001. At the end, as I said, across the areas 
that we look at in DHS, there is a real difficulty in getting 
agencies to sort of come to the table.
    There are concerns about privacy of data: Who controls the 
data? How will it get out? How will it be used? Who controls 
the use of it if there is a disagreement about something? As 
well as issues of, if there are disagreements, how will those 
be resolved? Those kinds of things tend to be the kinds of 
things that hold up these agreements, and they vary by 
different agencies as to what the specific issues are that are 
of concern to them.
    Mr. McCaul. Did I understand your testimony correctly that 
this is more voluntary? That there is no specific requirement 
that they sign these?
    Mr. Jenkins. That is correct.
    Mr. McCaul. So nothing in the 9/11 Act, no act of Congress 
has mandated that this happen?
    Mr. Jenkins. No. It is basically the ability to persuade, 
cajole, and negotiate.
    Mr. McCaul. Would it be helpful if Congress enacted more of 
a mandatory law?
    Mr. Jenkins. Perhaps it might be in the sense that it takes 
a long time. You can see how long it has taken here. There 
haven't been any new agreements signed since January 2007.
    Mr. McCaul. Right.
    Mr. Jenkins. That has certainly affected NBIC's ability to 
meet its operational goal.
    Mr. McCaul. This is an area where waiting can be lethal.
    Mr. Jenkins. Yes, sir.
    Mr. McCaul. With respect to the salmonella response, what 
was DHS's role in that response?
    Mr. Hooks. Our role within the salmonella response--I 
should first mention that our role is not to replace the Food 
and Drug Administration's role in that mission space. They have 
the primary authority for resolving that food contamination of 
that. But ours was initially to conduct the analysis, to 
understand the cascading effects of a food contamination event 
such as the salmonella event that we have seen. What are the 
economic impacts? What are the international ramifications? 
What other impacts can occur in the food sector, the public 
health sector that are not directly related to the salmonella 
event? Which is where FDA is working in that space.
    Additionally, because of the NBIC structure and people who 
are involved in that daily production cycle, as Eric Myers 
mentioned, we were able to provide the first interagency 
information on the probable source of the contamination 
independent of the FDA trace-back efforts and to be able to 
share that in the interagency. Our mission is to be looking 
forward in a cueing sense, whereas FDA is looking in a 
confirmatory role and will not share that information in an 
ongoing investigation. But yet, we need to be looking forward 
for the Federal Government to minimize the impact of these 
events, and we were able to do that.
    Additionally, we were able to bring other interagency 
members to the table, such as the Department of Defense, to 
help us better characterize the event. That is not a normal 
information flow that has been occurring. Additionally, we were 
able to bring State Department to the table in this NBIC 
construct to understand the implications if the source were 
with a foreign nation. We were able to bring specific 
information from Customs and Border Protection that is not 
normally brought into one of these food trace-back events, to 
be able to provide that to FDA to help them better characterize 
and improve their ability to do that. None of these efforts are 
replacing the effort of FDA; they are to augment and support.
    An additional area is in the private sector. With 
regulatory agencies, the private sector frequently will not 
share information or chooses not to. They were willing to bring 
that into the NBIC forum anonymously so that we could use that 
to help in the trace-back.
    Mr. McCaul. So you got a real-life case test, if you will, 
into what kind of response you are capable of dealing with. 
Will there be some sort of after-action report or lessons 
learned from this event?
    Mr. Hooks. Absolutely. That is our intent within the 
Department of Homeland Security. We have not broached that 
specifically with the Food and Drug Administration yet, but I 
think that will happen.
    Mr. McCaul. Thank you, Mr. Chairman.
    Mr. Langevin. I thank the Ranking Member.
    The Chair will now recognize Members for questions they may 
wish to ask of the witnesses. According to the committee rules 
of practice, I will recognize Members who were present at the 
start of the hearing based on seniority, so next is Ms. 
Christensen from the Virgin Islands for 5 minutes.
    Mrs. Christensen. Thank you, Mr. Chairman.
    Thank you for holding this hearing, and I am looking 
forward to the one in Rhode Island next week.
    I am going to ask a very basic question. First, you, Mr. 
Jenkins. We understand that you can't fully comment on the 
report until you have gone through the internal review process, 
but several questions have been asked and answered here that 
you are most likely to have first-hand knowledge because of 
your work on the report. So my very basic question: First of 
all, does NBIC represent a needed and necessary function to 
improve biosurveillance capabilities in the United States, or 
is it self-redundant, in your opinion?
    Mr. Jenkins. We are not in a position to say whether it is 
self-redundant or it isn't based on the work that we have done.
    But I would say that, as Mr. Hooks has said, there is a 
real need in this international environment to have as early a 
warning system as you can that, and this is absolutely 
critical, but that it have data that is credible, reliable, and 
actionable. The sooner that you can have that data, the better 
off you are in terms of being able to reduce the impact of the 
event. You may not be able to prevent the event, but you could 
prevent the impact of it.
    So whether it is NBIC or some other mechanism, there 
certainly needs to be something that provides the data from a 
variety of sources. There is no single source of data in the 
Government or in the private sector that is really going to get 
you there.
    Mrs. Christensen. Thank you.
    Either Mr. Myers or Mr. Hooks, one of the most important 
things in biosurveillance is rapid validation, of course, of 
the initial indicators and outbreaks, for example, 
environmental conditions. Some local indicators may point 
toward the emergence of a certain disease, but this must be 
verified. So what mechanisms, if any, are available to the NBIC 
to obtain the ground truth, to verify what you may pick up in 
the biosurveillance?
    Mr. Myers. The process that we use is a very basic analytic 
process, which is to be in a constant screening mode and 
setting thresholds for the types of reporting that we want to 
do. So based on that, there is a constant screening review, a 
reach-out through the member agencies and an extensive network 
of data sources to be constantly canvassing.
    When there is an event that starts to cue up that is more 
important or starts to really grow to a larger threshold, let 
me use salmonella and tomatoes, where you are now having to 
have a significant impact, the first thing that we do is just 
to simply establish a subgroup or a subcommittee that is 
working in an analytic product, and we do that in 24-hour 
cycles. So we pack the cycles together, because the need for 
reporting and the need for information usually grows 
exponentially. With that, you start to refine who has what data 
and what gaps there are, and so that while you are working a 
production environment, you are simultaneously also trying to 
go after the data that you don't have. You are trying to make 
that meet basically a 24-hour clock so that you are in a 
constant reporting.
    What does that is refine your effort, refine your 
conditions and allow you to start working early cueing while 
the science community is going through laboratory and 
laboratory results, and there is a necessary time and space 
that must take place to get those results to verify what you 
have.
    The marrying of this group of agencies and an NBIC, the 
importance is that you have a group and element in there that 
is the scientific community that wants to have positive results 
and proven results, and another aspect of that same group that 
realizes that there is a high demand for information sooner, 
sooner, and sooner. So when we talk about any kind of a culture 
clash, that is the one unified floor, area, region, virtually 
and literally, where you can have those discussions and put out 
your situation reports and the types of reports that leadership 
need on a continuing basis.
    Mrs. Christensen. My time is almost running out.
    One of the concerns that the committee and the 
subcommittees have had is the turnover in personnel and also 
transitioning as we move to a new administration.
    I read recently that Dr. Runge is leaving. So are we 
anticipating that his leaving will impede the progress toward 
the NBIC becoming fully operational? Or are we deep and broad 
enough to sustain his leaving?
    Mr. Hooks. Ma'am, I believe we are deep and broad enough to 
be able to sustain. The reason I believe that is this has 
significant interest by Secretary Chertoff right now as well, 
and he receives regular updates on the tomato salmonella event 
and what the NBIC is doing. He is committed to it. The Homeland 
Security Council is committed to improving the interagency 
sharing of information and creating that trusted environment. I 
am committed to that. Eric Myers has done a great job pushing 
that forward. So I think we have the team in place to be able 
to continue to push that vision forward effectively for the 
Nation.
    Mrs. Christensen. Thank you, Mr. Chairman.
    Mr. Langevin. Thank you.
    Mr. Wilson, did you want to respond to something that Mrs. 
Christensen had asked?
    Dr. Wilson. Yes, sir. Thank you very much. I appreciate 
that.
    The whole commentary about verification, that is a standard 
in outbreak detection and verification, and it was set by the 
World Health Organization and its partners about 10 years ago.
    I would just draw the subcommittee's attention to the point 
that a lot of the points raised here today have been focused on 
domestic. We are heavily connected to the rest of the planet by 
the air traffic and commerce grid. Things come in here all the 
time. I have a wide variety of pathogens listed in my 
testimony, a quite astounding list, actually. Therefore, we 
have to monitor holistically. When we do that, we are getting, 
in a near real-time basis routinely, we are detecting things 
and vetting them with international partners on the ground as 
it happens. You can't make a choice as to whether or not you 
are going to choose Federal capabilities or NGO or U.N. 
partners or what have you, because no single organization has 
ground verification capability that is that comprehensive. 
Obviously, that implies a whole range of information sources 
and credibility and so forth that has to be vetted by analysts, 
but therein is the challenge.
    Our ground verification network right now numbers 110,000 
people globally. We need that kind of help for this mission. By 
the end of the year, we will definitely be pushing over a 
quarter million. This is unprecedented in history for this 
country and really for global health. So I would encourage the 
subcommittee to consider leveraging any and all available means 
to assist in that mission, because that step is critical to 
verification.
    Mr. Langevin. If I could, with the indulgence of the 
gentleman from New Jersey, I just wanted to follow up on 
something.
    As you know, Global Argus is a biosurveillance system that 
compiles open-source information on foreign disease outbreaks. 
An outgrowth of Global Argus is the Veratect system, which was 
spun off from Georgetown University as a private company.
    Can you explain the key differences between the two 
projects? Does the fact that Veratect is a private U.S. company 
remove the Title 50 problem associated with Global Argus? How 
would you compare the capability of Global Argus or the 
Veratect system to the current capability of NBIC?
    Dr. Wilson. Yes, sir. Thank you for the question.
    As the former principal investigator of Project Argus, now 
with the Veratect Corporation, we have the entire senior 
analytic pool from Global Argus now with our team at Veratect 
Corporation.
    Currently, the system that we are utilizing has 36,000 
sources that we are utilizing compared to Global Argus's 
approximate 9,000. That gives us coverage of 86 percent of the 
world's population through this medium.
    There are two key differences that I am going to highlight 
here in a second between Argus and the current capability now 
available at Veratect Corporation. One is that we could not do 
domestic, which is what you were implying with the Title 50 
restrictions. We can now do that at Veratect. That was a 
critical gap, when we were tracking the H3N2 vaccine drifted 
strain from Asia and watched it spread throughout the world but 
we could not follow it as it entered there United States and, 
as we all have seen now, created quite a bit of problems for 
our influenza season last year.
    The second piece is, of course, as I mentioned before, the 
ground verification process, which is a critical step in our 
analysis. We must have that. We now have, as I mentioned 
before, we have 110 people around the world now as partners to 
help verify these events. We were unable to do that at Argus. 
Again, as I mentioned, we do do domestic, and Argus is unable 
to do that.
    For biological agent tracking, my team and I, who are now 
at Veratect, we monitored about 60 pathogens in coordination 
with our Federal users. We have actually expanded this list now 
to 200 pathogens that affect humans, humans and animals, and 
animals only. So we have a range actually of human health and 
agricultural issues, and we do cover food safety issues as 
well.
    We have research partners both in the national labs and 
transdisciplinary universities, so the bottom line here is, we 
started as a team designing a prototype, and now we have taken 
that to the next generation. We are now fully operational.
    This is truly a world-class capability that is going to 
continue to grow exponentially as we work with our partners 
around the world.
    Mr. Langevin. I find that very interesting. We will be 
watching this closely as it unfolds.
    With that, the Chair now recognizes the gentleman from New 
Jersey, Mr. Pascrell, for 5 minutes.
    Mr. Pascrell. Thank you, Mr. Chairman.
    Just to follow up, Mr. Wilson, if DHS had simply offered to 
fund Argus, would we have a domestic biosurveillance capability 
today?
    Dr. Wilson. No, sir. The nature of the funding at Argus 
prevented us from doing domestic analysis. Currently, at the 
Veratect Corporation, the team that was at Argus that worked 
with me, the entire senior staff, along with myself, now at the 
Veratect Corporation, we are able to do foreign and domestic 
analysis.
    Mr. Pascrell. Mr. Secretary Hooks, is it realistic to 
expect that the end game is to have sensors, biodetectors, as 
part of the surveillance systems in place throughout the United 
States of America? Is that the end game?
    Mr. Hooks. I think the end game needs to be based on what 
the risk is to the Nation.
    Mr. Pascrell. Well, what is the risk then, Mr.----
    Mr. Hooks. The risk is real for a biological attack or a 
naturally occurring biological event.
    Mr. Pascrell. Then let me ask this question to Mr. Jenkins.
    Did you sense in the GAO's review of the work, that you 
summarized--I just quickly read through your total report--do 
you sense a--and I know this is a judgment call--a sense of 
urgency in what you reviewed, in the people that are being held 
responsible for giving us a program here?
    Mr. Jenkins. I think they are very serious about it.
    Mr. Pascrell. I didn't ask you that question.
    Mr. Jenkins. What I am saying is, I think they do have a 
sense of urgency because they do believe that the threat is 
real and that we have to have some way of trying to deal with 
it. So I do think they have a sense of urgency.
    As I mentioned earlier, part of the problem in trying to 
get where we need to go is getting everybody fully on board and 
participating.
    Mr. Pascrell. I understand that. But it is 16 months. For 
instance, as an example, to your own report, 16 months before 
we have had another agreement, a mutual agreement. For you to 
sit there and provide a review--I have a tremendous amount of 
faith in GAO, as you well know--and not to go to the very heart 
of this issue, it would seem to me that if we can't get out of 
these eleven agencies some cooperation from five or six of 
them, there is a reason for that.
    We all know the reason, understand the reason.
    That doesn't help us secure a surveillance system that we 
can feel confident in. So my question to you again is do you 
sense a realistic view of urgency here?
    Mr. Jenkins. Well, I think maybe I didn't make myself 
clear. I was really referring to the NBIC folks as to whether 
or not they feel a sense of urgency. I think, in some cases, it 
seems relatively clear that other agencies who have been asked 
to participate, at least by their actions, don't indicate that 
they feel a sense of urgency.
    Mr. Pascrell. Well, one of the problems is, we had to wait 
until 2007 to pass the 9/11 Commission Act and its 
recommendations. As you well know, one of the reasons, one of 
the main reasons why it took us so darn long is that the 
administration would not get out of our way. So we understand 
that this has been delayed down the road.
    Let me ask you this question, Secretary Hooks. You have to 
prioritize in the business of defending the Nation. You are 
never going to have a seamless defense; we understand that, we 
all understand that. We are fallible human beings; I hope we 
all understand that.
    On a sense of priorities in terms of what you know and what 
we know and what those people who have inside intelligence 
about where we are in defending our neighbors and our children 
and our neighbors and the United States of America, where would 
you put a bioattack in regards to prioritizing what we need to 
be most prepared for at this moment in the history of mankind?
    Would you be concerned about, for instance, nuclear attack? 
Would you be concerned about the bioattacks, the very pathogens 
that you were talking about just a few moments ago? How would 
you prioritize it?
    Mr. Hooks. I think that is a challenge obviously, 
integrating across the entire threat and risk space, 
considering the threat vulnerability and consequences.
    I believe in the time that I have been working in the 
Office of Health Affairs and the information that I have 
learned that a biological attack or a naturally occurring event 
is a higher priority than I think it has been viewed at within 
the country.
    Mr. Pascrell. Yeah, I would tend to agree with you.
    But if that is the case, if that is the case and we are 
waiting 16 months for the next mutual agreement, what does that 
tell you? How do you respond to that?
    Mr. Hooks. The way I respond to that is, that is where my 
sense of urgency comes from and the people that are working on 
this issue. Within that sense of urgency, we have brought the 
other agencies to the table in discussion. We have not 
finalized some of those memorandums of understanding that have 
been identified by Mr. Jenkins. But I think we are making 
significant progress in creating interagency collaboration and 
information sharing.
    Mr. Pascrell. You are waiting for a mere pittance, Mr. 
Chairman, relatively speaking--$2 million, $2.5 million you are 
waiting for.
    Mr. Hooks. Two-point-two million, sir.
    Mr. Pascrell. In this huge budget, and we can't get out of 
our own way in order to provide these guys and gals with the 
amount of resources that they need to do the job.
    I would suggest to you, Mr. Chairman, that this is urgency 
by word and not by deed in this administration, and that we are 
at risk because of it--pure and simple.
    I have no further questions. Thank you.
    Mr. Langevin. Well, I share the gentleman's sense of 
urgency and frustration that we are not moving along, if it is 
a lack of resources; and both the administration and the 
Congress has to press this issue to make sure we get the right 
resources in the right place. I, for one, believe that a 
biological attack or the biological threats that we face, 
whether it is man-made or naturally occurring, are very 
serious, very real.
    The American people expect that we are going to get this 
right and we are going to protect the country. We are going to 
continue our rigorous oversight of this issue, and we will 
continue to partner with you in every way possible to make sure 
that we are closing the vulnerability of biological threats.
    With that, I want to thank the witnesses for their 
testimony. There are votes on right now. So I am going to 
dismiss this panel.
    We have the BioWatch hearing coming up as the second 
hearing to this overall effort today.
    So, again, I want to thank the witnesses for their 
testimony. The Members of the subcommittee may have additional 
questions for the witnesses. We will ask that you respond 
expeditiously in writing to those questions.
    With that, this panel is adjourned. The subcommittee now 
stands in recess.
    [Recess.]
    Mr. Langevin. The subcommittee will come to order. First of 
all, let me apologize for the delay. As you have learned, 
unfortunately, around here our lives are not our own, and that 
was the longest 45 minutes I have ever had. I thought we would 
be done a lot quicker than that. Unfortunately, Members had 
other ideas.
    So I do want to thank the panel sincerely for waiting 
around. Obviously, this is a very important issue, and 
something I am anxious to get to. So without any further 
hesitation, let me convene our second panel on BioWatch.
    The first witness is Robert Hooks, who has testified on the 
first panel. Again we thank you for remaining for the second 
panel.
    The next witness is Dr. Jeffrey Stiefel, Director of the 
Early Detection Division, and Program Executive of BioWatch, 
Office of Weapons of Mass Destruction, WMD, and Biodefense at 
the Office of Health Affairs, Department of Homeland Security. 
Thank you for joining us.
    Remaining on the panel is William Jenkins of the GAO. We 
appreciate you, of course, remaining on the second panel to 
discuss BioWatch.
    Finally, we welcome Dr. Frances Downes, who is the 
Administrator of the State Public Health Laboratory at the 
Michigan Department of Community Health. Her lab is a member of 
the Laboratory Response Network and participates in the 
BioWatch program.
    Without objection, the witnesses' full statements will be 
inserted in the record. Again, I want to thank all of our 
panelists today, and I want to now ask each witness to 
summarize his or her statement for 5 minutes, beginning with 
Mr. Hooks, who will read a joint statement for himself and Dr. 
Stiefel.
    Welcome.

 STATEMENT OF ROBERT HOOKS, DEPUTY ASSISTANT SECRETARY FOR WMD 
    AND BIODEFENSE, OFFICE OF HEALTH AFFAIRS, DEPARTMENT OF 
                       HOMELAND SECURITY

    Mr. Hooks. Thank you, Mr. Chairman and Representative 
Christensen. I appreciate your interest in biosurveillance 
programs and trust that my testimony today will provide 
valuable insight into the Department's biosurveillance 
initiative to safeguard the Nation against a biological attack 
or other biological incidents that threaten the security of the 
homeland.
    The Nation continues to face the risk of a major biological 
event that could cause catastrophic loss of human life, severe 
economic damages, and significant harm to our Nation's critical 
infrastructure and key resources. Because of the challenges we 
face in assessing current terrorist capabilities and 
identifying plots, it is unlikely we will receive actionable, 
specific warning of an impending bioterrorist attack. 
Furthermore, many of these deadly biological agents are 
accessible in nature, relatively easy to procure, develop and 
transport without an advanced background in the biological 
sciences. Unlike nuclear weapons, few people with advanced 
laboratory knowledge in the biological sciences are needed to 
weaponize these deadly pathogens. As such, it is incredibly 
difficult to predict and prevent a biological attack from 
taking place.
    Biosurveillance includes many different components that 
work in complementary fashion to achieve a comprehensive 
awareness. This takes the form of both traditional and novel 
methods of early event detection, including environmental 
detection systems, clinical syndromic surveillance, reportable 
disease and laboratory base surveillance, monitoring of 
agriculture and wildlife activity, testing of the food supply, 
and monitoring mail and open-source analysis to name a few. 
Each is a necessary and valuable component of a comprehensive 
biosurveillance strategy.
    The BioWatch mission is to deploy and maintain a national 
24/7 early warning system capable of detecting the intentional 
release of select, aerosolized biological agents in order to 
speed response and recovery efforts, primarily focused on 
aerosolized anthrax. The purpose of this early detection and 
warning capability is to mitigate the consequences of a 
catastrophic attack which could affect tens of thousands of 
people if, for example, aerosolized anthrax were released.
    BioWatch is a part of a national biodefense strategy that 
includes intelligence, law enforcement, biomonitoring, 
situational awareness, decision support, response, and recovery 
activities. Within this strategy, BioWatch is an essential 
component of biomonitoring, along with astute clinicians, 
syndromic surveillance, food and agriculture monitoring, 
veterinary surveillance, and mail room monitoring. BioWatch is 
operating in over 30 of the Nation's largest metropolitan 
areas, and consists of aerosol collectors, secondary sampling 
kits, laboratories, guidance documents, concepts of operations, 
communications protocols, an Internet-based information portal, 
subject matter experts, and a small number of early-generation 
indoor detectors.
    It is more than just detectors in the field. The BioWatch 
laboratories have been in continuous operation since 2003 and 
have analyzed more than 7 million samples without a single 
laboratory false positive result--an incredible feat.
    The BioWatch operational readiness is essential for the 
system to be effective. Representatives from the agencies, 
along with State and local public health and response personnel 
have created guidance documents for local jurisdictions to use 
in developing operational plans for BioWatch. These guidance 
documents cover preparedness response, environmental sampling, 
and indoor operations.
    The operational response plans for each jurisdiction are 
triggered by a BioWatch Actionable Result, and implemented by 
the local BioWatch Advisory Committee, or BAC. Investigations 
and discussions continue until consensus is reached about the 
significance of the BioWatch Actionable Result, which is used 
to inform the protective action decisions on the part of the 
local public health officials.
    One of our highest priority initiatives is to replace 
collectors, the filters that require formal laboratory 
analysis, with automated detectors wherein the analysis is 
performed within the unit itself. The primary objective of the 
Generation 3 system is to introduce technological advancements 
that will significantly reduce the time to detect a biological 
agent from the current 10 to 34 hours down to between 4 and 6 
hours, which will potentially save thousands of lives for each 
day an attack, such as anthrax, is detected ahead of human 
syndromic surveillance and other public health indicators.
    In conclusion, the challenge of detecting an invisible 
footprint of an impending bioterrorist plot and preventing an 
attack or the emergence of a pandemic is daunting. That is why 
DHS is taking the approach to enhance early detection systems 
and build a national biosurveillance capability for situational 
awareness.
    Thank you for the opportunity to testify.
    Mr. Langevin. Thank you, Secretary Hooks.
    [The joint statement of Mr. Hooks, Mr. Myers and Dr. 
Stiefel appeared previously in this document.]
    Mr. Langevin. I now turn to and recognize Mr. Jenkins to 
summarize his statement for 5 minutes.

   STATEMENT OF WILLIAM O. JENKINS, JR., DIRECTOR, HOMELAND 
 SECURITY AND JUSTICE ISSUES, GOVERNMENT ACCOUNTABILITY OFFICE

    Mr. Jenkins. Thank you, Mr. Chairman, Ms. Christensen.
    The United States faces potentially dangerous biological 
threats that may occur naturally or as a result of a terrorist 
attack. Concern about the dispersal of lethal biological agents 
or widespread infectious disease outbreaks focused attention on 
the need for systems that can provide reliably accurate early 
detection and warning.
    BioWatch is intended to be such an early warning system. It 
deploys detectors to collect aerosol samples daily that are 
then analyzed to detect the presence of specific biological 
agents. The success of the program is dependent upon three 
things: accurate sampling, timely and accurate analysis that is 
actionable, and then actions based on that analysis. DHS has 
two ongoing efforts to improve the detection and analysis 
technology used by the BioWatch program, and the remainder of 
my statement today focuses on those issues alone.
    Currently, BioWatch detector samples must be manually 
collected, then transported to a lab for analysis, a process 
that can take, as Mr. Hooks said, from 10 to 34 hours. The 
manual collection and analysis inherently adds to the time it 
takes to identify the presence of the agents that are being 
monitored.
    BioWatch is developing two new types of detectors designed 
to reduce the time it takes to analyze samples. The first, 
Generation 2.5, which is designed as an interim measure, would 
automate the analysis of samples, but detect and analyze the 
same agents that are now being monitored. The second 
generation, 3.0, would also be capable of automatic sample 
analysis, but in addition would eventually have the capability 
to detect all biological agents on the threat list.
    According to DHS officials, the ability of the detectors to 
automatically analyze the samples they collect on a regular or 
prescribed schedule could reduce the elapsed time between air 
sampling and detection from 10 to 34 hours to 4 to 6 hours. In 
addition, the deployment of Generation 2.5 and 3.0 detectors 
would expand the use of the detectors in indoor environments. 
Current detectors focus on exterior sampling primarily.
    DHS officials say they plan to develop procedural guidance 
for responding to positive results from indoor detection by 
October 2008 and apply it to all detectors employed indoors. 
Currently, there is no procedural guidance for responding to 
indoor detection of biological agents.
    DHS said that it plans to begin operational testing and 
evaluation of 2.5 Generation detectors in November 2008, and 
acquire about 100 of them if the testing is successful. Testing 
for Generation 3.0 detectors is scheduled for April 2009.
    DHS plans to replace all detectors with Generation 3.0 by 
2013, with initial deployment beginning in 2010. In addition, 
the Gen 3.0 detectors are expected to be less costly to both 
purchase and maintain than the 2.5 detectors--about 30,000 less 
to purchase, according to DHS, and 53,000 to 31,000 annually 
less to operate and maintain.
    That concludes my statement, Mr. Chairman, and I would be 
pleased to respond to questions you or other Members may have.
    Mr. Langevin. Thank you, Mr. Jenkins.
    [The statement of Mr. Jenkins appeared previously in this 
document.]
    Mr. Langevin. The Chair now recognizes Dr. Frances Downes 
for 5 minutes.
    Welcome.

    STATEMENT OF FRANCES POUCH DOWNES, STATE PUBLIC HEALTH 
 LABORATORY DIRECTOR, DEPARTMENT OF COMMUNITY HEALTH, STATE OF 
                            MICHIGAN

    Dr. Downes. Mr. Chairman and subcommittee Member 
Christensen, thank you for inviting me to testify today about 
the State and local government experience with the Department 
of Homeland Security's BioWatch Program. As I was introduced, I 
am Dr. Frances Downes, Director of the Michigan Public Health 
Laboratories.
    State and local public health laboratories are an essential 
part of the Nation's preparedness infrastructure. Michigan is 
one of 24 public health labs that host the BioWatch program. I 
am also the current President of the Association of Public 
Health Laboratories, APHL, a national nonprofit that is 
dedicated to working with its members to strengthen 
governmental laboratories with a public health mandate.
    In March 2003, Michigan became a host laboratory for the 
BioWatch program. The security climate in the United States was 
very different than it is today. Public health labs had just 
come off the testing demands of the 2001 anthrax exposures. 
Biological weapon caches were still a purported threat. DHS 
contacted security officials in States with major urban centers 
and, together, determined that BioWatch testing would be a 
security asset.
    When we in the public health laboratory community were 
asked to install BioWatch testing programs, we did what we 
always do to meet the challenges to protect the public's 
health. I was willing to take on the hosting program because it 
was clear that the response to a positive result would be 
primarily State and local. If I hosted testing, I could control 
the safety of the testing personnel and assure the quality of 
testing. Unfortunately, we have never hit this mark, and we are 
moving farther away from it.
    At that time, verbal promises were made regarding support 
for the program. Did we get those promises in writing? No.
    We are not contractors or vendors. Public health functions 
in a culture of partnership. Public health laboratories are 
part of a system that, for over a century, has been committed 
to providing services in the interests of our public health 
communities.
    BioWatch space demands have grown at an unrestricted pace. 
The image you see on the monitors indicates the initial 
footprint of the BioWatch program in Michigan in 2003. The red 
space is exclusively for BioWatch use, and it cannot be used 
for public health priorities. The yellow space is shared 
between BioWatch and Michigan testing.
    This next image shows the BioWatch footprint in 2008. You 
can see the significant growth in space that is utilized by 
BioWatch. These images are just from the first floor of the 
Michigan laboratory, but they are followed by images on the 
second floor over the same period. More equipment, dedicated 
sample receipt areas, servers, supply storage, the demands are 
limitless.
    I have also brought along some photos that show how much of 
our space is used to store BioWatch supplies, equipment, and 
other material. All the items displayed in these photos are 
only for BioWatch use.
    I would also like to briefly give voice to some of our 
major concerns about BioWatch that we have included in our 
correspondence to you.
    DHS and its BioWatch contractor have no written agreement 
with, or contractual relationship, legal authority, regulatory 
or otherwise, with State and local public health labs, yet DHS 
is contractually obligated to their contractor to provide 
laboratory space. Because there is no agreement of any sort 
between public health labs and DHS or their contractors, there 
is no ability to require adherence to standard operating 
procedures and policies, even those related to laboratory 
safety.
    DHS has distributed a draft memorandum of agreement to 
address this matter, but it is unlikely that the State and 
local governments will enter into an agreement soon. For 
starters, DHS has said they will not reimburse the use of 
laboratory space and storage space, an issue they say is 
nonnegotiable.
    State and local public health labs have not received 
funding from DHS to support the expanding cost of testing 
programs, but other State agencies collecting the samples and 
transporting them to our laboratories daily are reimbursed for 
their expenses. To be blunt, this amounts to nothing less than 
a Federal Government demanding a match from State and local 
government to defray the cost of a Federal program with no 
limits, no control on the direction of the program, but almost 
total responsibility for response. The lab absorbs the cost, 
including lab space with utilities, and removal of infectious 
waste materials, support services, training, IT infrastructure, 
telephones, cell phones, vaccinations, on-site scientific 
direction, and expertise.
    The draft MOU, in fact, would increase the cost on labs by 
requiring them to pay for maintaining certification on lab 
equipment and information technology, costs currently covered 
by DHS. With State and Federal preparedness budgets shrinking 
at the same time, the burden of the costs incurred for hosting 
BioWatch will reach a critical mass in the near future. 
Although the lack of any written or contractual relationship or 
legal authority precludes BioWatch from being considered an 
unfunded Federal mandate, its effect on State and local 
obligations is the same.
    Prior to January 2008, when a new contract was awarded, 
State and local labs were able to provide input on personnel 
matters, including having the final say on job offers, 
contributing to performance evaluations. Under the proposed 
MOA, these oversight roles are lost. Public health labs have 
other contract employees and Federal assignees working in our 
facilities and provide oversight without interfering with those 
employer rights and responsibilities.
    The draft MOU provisions on cross-training BioWatch 
contract personnel to perform other preparedness and public 
health emergency testing is overly restrictive. Those 
provisions greatly reduce the ability of having BioWatch 
contract personnel trained for public health emergencies, such 
as the ongoing Nation-wide salmonella outbreak or helping out 
with testing related to the Midwest floods.
    The State and local public health laboratories would prefer 
to work with the BioWatch program in a more constructive and 
direct manner, and my written testimony has several 
recommendations for DHS to consider. With funding and increased 
management oversight, public health lab directors would be able 
to improve work flow, promote cross-training among 
laboratorians to increase testing capacity for public health 
emergencies, and improve laboratory quality in BioWatch 
locations.
    The BioWatch program has been variously described by my 
fellow State and local lab directors as a ``parasite'' to the 
public health laboratory and ``squatters'' in valuable 
laboratory space. I am hard pressed to disagree.
    This concludes my testimony. Thank you again for inviting 
me to participate in this hearing.
    [The statement of Dr. Downes follows:]
               Prepared Statement of Frances Pouch Downes
                             July 16, 2008
    Mr. Chairman and Members of the subcommittee: Thank you for 
inviting me to testify about the State and local government experience 
with the Department of Homeland Security's BioWatch program. I am Dr. 
Frances Pouch Downes, the director of the State of Michigan public 
health laboratory--in the Michigan Department of Community Health. 
State and local public health laboratories are an essential 
infrastructure program that support testing for public health programs 
and serve as the reference laboratory to hospital and clinical 
laboratories Nation-wide. Michigan is one of 24 public health 
laboratories that host the BioWatch program. I am also the current 
President of the Association of Public Health Laboratories (APHL). APHL 
is a national non-profit located in Silver Spring, Maryland, that is 
dedicated to working with its members to strengthen governmental 
laboratories with a public health mandate. By promoting effective 
programs and public policy, APHL strives to provide public health 
laboratories with the resources and infrastructure need to protect the 
health of U.S. residents and to prevent and control disease globally.
    In March 2003, the Michigan Bureau of Laboratories became a host 
laboratory for the BioWatch program. The security climate in the United 
States was very different than it is today. Public health labs had just 
come off the intensive testing demands of the 2001 intentional anthrax 
exposures. Biological weapons caches were still a purported threat. DHS 
contacted State security officials in States with major urban centers 
and determined that the BioWatch testing program would be a security 
asset. When the public health laboratories were asked to install the 
BioWatch testing program, we did what we always do: Meet the challenges 
to protect the public's health, which in this instance meant devoting 
considerable resources to receiving and installing equipment and 
supplies, being trained, training the contractors who would perform the 
testing and participating in the development of response plans. The 
response plans made it clear that I would be responsible for result 
interpretation and initiating the cascade of events that ensue after a 
positive result. Therefore, I was willing to take on the burden of 
hosting the program, if I could control the safety of the testing 
personnel and assure quality of testing. I accepted the program with 
the caveats that the program did not divert us from other essential 
public health testing priorities and I controlled quality and safety of 
the testing program. Unfortunately, we have never hit this mark and are 
moving further away from it.
    At that time verbal promises were made regarding support for 
hosting the program. Did we get these promises in writing? No. We are 
not contractors or vendors. We function in a culture of partnership. 
Public health laboratories are part of a system that for over a century 
has been committed to providing the services in the interest of the 
health of our communities.
    The technology and the mechanisms for acquiring testing personnel 
have evolved since the inception of the BioWatch program but the 
contribution of the host laboratories has never been considered by DHS 
nor have the safety and quality responsibilities of the host 
laboratory.
    First, space demands have grown at an unrestricted pace. The image 
you see on the monitors indicates the initial footprint of the BioWatch 
program in the Michigan lab in 2003. The red space is exclusively for 
BioWatch use and cannot be used for Michigan public health testing 
priorities; the yellow space is shared between BioWatch and Michigan 
public health testing. This next image shows the BioWatch footprint in 
2008 and you can see the significant growth in the red space that is 
dedicated to BioWatch. These images from the first floor of the 
Michigan laboratory are followed by images that display the growth on 
the second floor over the same period of time. More equipment, 
dedicated sample receipt area, server, and supplies. The demands are 
limitless.
    [The images follow:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    

    To give you a better visual perspective of the impact BioWatch has 
had on the Michigan laboratory, I've also brought along some pictures 
that show how much of our space is used to store BioWatch supplies, 
equipment and other materials. All of the items displayed in these 
pictures are only for use in the BioWatch program. None of these 
pictures show the actual equipment used to perform testing on BioWatch 
samples or the space that equipment occupies.
    [The images follow:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    

    Mr. Chairman, APHL has provided you with correspondence that 
details the significant concerns related to the BioWatch program and 
its presence in public health laboratories. I would like to briefly 
give voice to some of our major concerns:
   No agreed-upon roles and responsibilities between DHS, its 
        contractor and Public Health Laboratories.--At present, DHS and 
        its BioWatch contractor have no contractual relationship or 
        legal authority, regulatory or otherwise, with State and local 
        public health laboratories for the operations of the BioWatch 
        program. Yet, DHS is contractually obligated to the BioWatch 
        contractor to provide laboratory space (Section 4.1 of Task 
        Order No. HSHQDC-08-F-00016).
      Because there is no agreement of any sort between the State and 
        local public health laboratory and DHS or BioWatch contractor, 
        there is no ability to require adherence to site specific 
        quality assurance practices, standard operating procedures and 
        policies--even those that relate to laboratory safety. 
        Furthermore the absence of any agreement has spurred State and 
        local government legal offices into action because of their 
        concern over the exposure to these governments, including 
        unresolved liability and worker's compensation issues.
      DHS has distributed a draft Memorandum of Agreement (MOA) to 
        address this matter, but the details included in the draft make 
        it unlikely that State and local governments will enter into an 
        agreement soon. For starters, DHS has said they will not 
        reimburse for the use of laboratory and storage space--an issue 
        they say is non-negotiable. Again, the draft MOA does not limit 
        the space and administrative demands that the BioWatch program 
        can place on a laboratory. Also, while DHS proposes one MOA 
        that will be utilized nationally, the unique legal issues in 
        each State and local government must be recognized and they 
        demand individual resolution.
   Uncompensated Laboratory Costs.--State and local public 
        health laboratories have not received funding from DHS to 
        support the cost of housing and overseeing the BioWatch program 
        whereas the State agencies collecting the samples and 
        transporting to the public health laboratories daily are 
        reimbursed for their expense. I have already mentioned the key 
        non-negotiable element of reimbursement as it relates to the 
        draft MOA. The message transmitting that draft MOA asserts: 
        ``DHS cannot enter into an arrangement to reimburse for space, 
        due in part to funding limitations, and in large part to the 
        Anti-deficiency Act, which precludes long term commitments 
        without sufficient funds appropriated.''
      To be blunt, this amounts to nothing less than the Federal 
        Government demanding a match from State and local governments 
        to defray the expenses of a Federal program with no limits, no 
        control on the direction of the program but almost total 
        responsibility for response. The State and local public health 
        laboratories absorb costs associated with administration, 
        training, and safety for BioWatch-contracted personnel. These 
        costs include laboratory space with utilities, removal of 
        infectious waste material, support services, training, 
        computers, telephones and cell phones, vaccinations, and on-
        site scientific direction and expertise on questionable 
        results. As I've shown you, the BioWatch footprint continues to 
        expand in the host laboratories, often taking up extensive 
        space in multiple rooms.
      For example, in one public health laboratory, the BioWatch 
        program occupies 975 square feet of laboratory space in 8 rooms 
        on 4 floors. In addition to the costs of providing space and 
        administrative oversight, laboratories may need testing 
        personnel to maintain daily testing or to support intensive 
        testing that occurs during high profile special events (like 
        political party conventions, sporting events). Two public 
        health laboratories only have one BioWatch-contracted employee 
        and must use State laboratory employees to complete BioWatch 
        testing despite informing DHS of this work force shortage over 
        a year ago. In plans to prepare for intensive testing or 
        contract employee vacancy, the BioWatch contractor is to 
        establish a contract and pay State employees to provide 
        additional testing capacity. However, the contractor has been 
        slow to sign, or has not signed these State employees on. Also, 
        the contractor is on record of approving an insufficient amount 
        of time for training and other quality assurance activities 
        that will prepare the State employees for the situation when 
        they are needed. Finally, these employees may not be available 
        in the event of a bioterrorism emergency and great testing 
        demand because their primary responsibility is to fulfill their 
        role to the Laboratory Response Network (LRN). As the primary 
        and career employer, the State laboratory director will 
        determine the individuals assignment; not a contractor.
      Further, the draft MOA would require that the State and local 
        laboratories pay for the cost of maintaining certification on 
        laboratory equipment used in BioWatch testing--costs that were 
        previously covered by DHS.
      Most alarming is the situation in one State where the current 
        BioWatch contractor has been very reluctant to address any of 
        the problems related to the daily operation of the BioWatch 
        laboratory. When the new contract was awarded, payment for the 
        internet connection service used by the BioWatch program was 
        terminated. When the new contractor was informed of this 
        problem, they suggested that the State laboratory pay for the 
        service--an option the laboratory declined. This problem has 
        yet to be resolved. With State and Federal preparedness budgets 
        shrinking at the same time, the burden of the costs incurred 
        for hosting BioWatch will reach critical mass in the near 
        future.
      Although the lack of any contractual relationship or legal 
        authority precludes BioWatch from being considered an unfunded 
        Federal mandate, its effect on State and local obligations is 
        the same.
   Management and Oversight of Contract Employees at the Local 
        Level.--In January 2008, DHS awarded the BioWatch staffing 
        contract. In May 2008, public health laboratories hosting the 
        BioWatch program received a communication from DHS (attached) 
        explaining that the non-personal services nature of the 
        BioWatch contract greatly restricts the roles of DHS and the 
        public health laboratories in the management of the BioWatch-
        contracted personnel. I would call attention to this portion of 
        the DHS explanation which compounds the challenges for State 
        and local public health laboratories hosting the BioWatch 
        program: ``The current contract that the Department of Homeland 
        Security (DHS) has with A-TEK, Inc. is a nonpersonal services 
        contract. The following definition of a nonpersonal services 
        contract comes from the FAR, Part 37.101: ` ``Nonpersonal 
        services contract'' means a contract under which the personnel 
        rendering the services are not subject, either by the 
        contract's terms or by the manner of its administration, to the 
        supervision and control usually prevailing in relationships 
        between the Government and its employees.' '' (Emphasis added.)
      The host laboratories are neither Federal Government nor 
        employees of the Federal Government.
      Since the transition of BioWatch-contracted personnel to the new 
        contractor, public health laboratory directors have struggled 
        to maintain open lines of communications with the contractor, 
        BioWatch-contracted personnel located in our labs and DHS. 
        Communication has been constrained by contractor-issued 
        directives that prohibit BioWatch-contracted personnel and 
        supervisors from fully communicating with their public health 
        laboratory counterparts and fail to understand how fully 
        integrated BioWatch operations and personnel are with public 
        health laboratory operations and employees.
      Contract employees are instructed to contact the contractor in 
        the event of quality control failures or positive results. 
        There is no reason for this communication to occur since the 
        contractor is not involved in response and CDC provides quality 
        assurance consultation. It is imperative that lines of 
        communication are seamless and totally unrestrained to assure 
        the most efficient and effective laboratory operations. The 
        advice and direction by the contractor will only confuse the 
        response and is not welcome nor needed.
      Prior to the issuance of the January 2008 BioWatch contract, the 
        State and local laboratories were able to create salary parity 
        between the BioWatch-contracted personnel and State laboratory 
        employees based on prevailing local compensation; and they were 
        able to have the final say on which interviewees received job 
        offers, contribute to performance evaluations, and determine 
        disciplinary actions to be taken by the contractor. Under the 
        proposed MOA described previously, these oversight roles are 
        lost. In fact the current contractor instructs their employees 
        not to communicate with host laboratory personnel on many 
        issues including wages. Public health labs have other contract 
        employees and Federal assignees working in our facilities and 
        provide oversight without interfering with employer rights and 
        responsibilities. It is only this contract that has put us at 
        odds with the contractor.
      Public health laboratory directors are legally responsible under 
        State and Federal law for the safety of all activities that 
        occur within their laboratory, including all who work within 
        their laboratory. This includes determinations on who has 
        access to and is working in the laboratory (laboratory 
        security), what analytical procedures are undertaken and how 
        they are performed (laboratory safety and practice), and fair 
        and equitable treatment and supervision among all laboratory 
        staff (laboratory operations and employee morale), among 
        others. BioWatch needs to run in parallel to the existing State 
        and local public health laboratory infrastructure and it must 
        not undermine that infrastructure with determinations on the 
        internal operations of these laboratories, like whether the 
        BioWatch-contracted personnel should be registered in the CDC's 
        Select Agent program. The work location alone suggests Select 
        Agent registration.
   Science and Technology.--To date, State and local public 
        health laboratory directors have not been provided with the 
        performance data (sensitivity, specificity, limits of 
        detection) that are necessary for them to make the best 
        judgment possible on any BioWatch Actionable Result (or BAR). 
        In addition, many of these laboratories have expressed interest 
        in providing input into the evaluation and implementation of 
        new technologies as this has a direct impact on the use of 
        laboratory space, personnel, and utilities as well as BAR 
        response. New technologies have simply been foisted upon the 
        laboratory without adequate preparation, including the 
        performance data referenced above. Additionally, some public 
        health laboratory scientists are concerned that there may be 
        naturally occurring background levels of some pathogens in 
        surveyed cities, such as Francisella tularensis in Houston, 
        Texas, leading to positive findings in the BioWatch program 
        which do not result from bioterrorism. Other than descriptive 
        data from studies conducted in Houston, and Virginia, public 
        health laboratories have not been privy to data depicting the 
        background levels and types of organisms in the environment.
   Other Issues.--In the draft MOA, DHS continues the practice 
        of asserting that BioWatch-contracted personnel do not have to 
        go through the Department of Justice's Security Risk Assessment 
        (SRA) clearance process. The SRA is required for any 
        individuals who may have access to select biological agents and 
        toxins. This is in direct conflict to the statement in the 
        draft MOA that the contract employees may spend up to 25 
        percent of their time working on Category A and B agent 
        testing. The biological select agents are all included in 
        Category A. Due to the space demands of the BioWatch program, 
        contract employees may be working in areas that provide them 
        access to select agents. The draft MOA provisions on cross-
        training that restrict BioWatch-contracted personnel to only 
        perform testing on environmental samples and not work on 
        clinical specimens is overly restrictive. This greatly reduces 
        the utility of having BioWatch-contracted personnel cross-
        trained for public health emergencies, such as the ongoing 
        Nation-wide Salmonella outbreak.
    State and local public health laboratories work closely with the 
CDC's Laboratory Response Network (LRN) to provide analytical support 
for the BioWatch program. Many of these laboratories have limited 
interactions with DHS. The public health laboratory personnel who 
perform LRN testing also would perform follow-up or Phase 1 Response 
testing on a BAR. It is important for both the staff of the public 
health laboratory and any BioWatch-contracted personnel to work closely 
together and fully understand all testing procedures.
    The State and local public health laboratories would prefer to work 
with the BioWatch program in a more constructive and direct manner and 
recommend that DHS consider the following options for the BioWatch 
program:
    I. Fund State and local public health laboratories through a DHS 
        cooperative agreement mechanism to manage the BioWatch program. 
        This mechanism could either be with APHL or directly with the 
        jurisdictions. With direct funding to the State and local 
        jurisdictions, the BioWatch-contracted personnel would become 
        employees of the State or local laboratory and can be easily 
        cross-trained and integrated into the public health laboratory. 
        This would allow the public health laboratory director to 
        fulfill their responsibilities to their jurisdictions (and 
        comply with all applicable Federal and State regulations 
        pertaining to the laboratory). A cooperative agreement would 
        allow for significant programmatic involvement by DHS and 
        collaboration by the public health laboratory.
    II. Provide funding to States to via the CDC Public Health 
        Emergency Preparedness (PHEP) Cooperative Agreement--it is 
        important to note that PHEP Cooperative Agreement funds are 
        shrinking and State and local public health laboratories cannot 
        take on additional activities, such as BioWatch without an 
        adequate investment from DHS. Using the PHEP Cooperative 
        Agreement mechanism, a designated sum of money can be set aside 
        for each BioWatch host laboratory.
    III. Remove the limitation on the ability of State and local public 
        health laboratories to cross-train BioWatch-contracted 
        personnel that limits them to testing environmental samples. 
        Cross-training of BioWatch-contracted personnel should be more 
        broadly applied to testing clinical specimens and environmental 
        samples of public health significance, such as the work done 
        under the CDC Public Health Emergency Preparedness cooperative 
        agreements. This would allow for more effective and robust 
        testing capacity in a surge situation and would increase 
        employee morale as they would be integrated into the laboratory 
        operations.
    IV. Investigate the use of contractor incentives to foster 
        integrated management of BioWatch-contracted personnel.
    V. Until such time when an improved mechanism is in place, DHS must 
        work directly with State and local public health laboratories 
        and other vested partners to ensure that BioWatch-contracted 
        personnel applicants and hires: (a) Meet minimum hiring 
        qualifications equivalent to public health laboratorians 
        performing the same work; (b) accept the hiring recommendation 
        of the public health laboratory director or designee; (c) can 
        interact effectively and productively with the public health 
        laboratory staff; (d) are subject to public health laboratory 
        policies and procedures, and (5) abide by all public health 
        laboratory safety and security rules and policies. Further, DHS 
        should require the BioWatch contractor to consult with the 
        public health laboratory director when evaluating BioWatch-
        contracted personnel so that the public health laboratory 
        directors can provide input into employees' evaluations with 
        respect to laboratory productivity, safety, and security, and 
        interaction with co-workers.
    APHL members and staff met with the senior DHS BioWatch leadership 
in the Office of Health Affairs on November 19, 2007, to ensure they 
understood the role of State and local public health laboratories and 
APHL in homeland, including BioWatch and need for continued and 
enhanced communications. Once the BioWatch contract was awarded, APHL 
sent the attached January 17, 2008 letter to Dr. Runge outlining 
concerns about a number of personnel matters that developed with the 
award of the new contract and suggesting options for improvements. No 
reply has been received to this letter as of today's date.
    Additionally, the association has documented our communication to 
DHS regarding the public health laboratory community's interest on 
communicating its recommendations concerning BioWatch. The process of 
developing memoranda of agreement with the public health laboratories 
may ultimately address these concerns; however because of the urgent 
need for some immediate solutions an interim approach is also needed.
    APHL works to safeguard the public's health by strengthening public 
health laboratories in the United States and globally. We advance 
laboratory systems and practices, and promote policies that support 
healthy communities. APHL and its State and local public health 
laboratory membership are committed to working with DHS to assure that 
laboratories are adequately funded to support the BioWatch program and 
to improve the overall management of BioWatch-contracted personnel.
    With funding and increased management oversight, public health 
laboratory directors would be able to improve workflow, promote cross-
training among laboratorians to adequately utilize staff and improve 
quality laboratory practices by implementing standard quality control 
measures in all BioWatch locations.
    The BioWatch program has been variously described by my fellow 
State and local laboratory directors as a parasite to the public health 
laboratory and squatters in valuable public health laboratory space. I 
am hard-pressed to disagree.
    This concludes my testimony, and I thank you again for inviting me 
to participate in this hearing.
     Attachment 1.--FAR 37 PERSONAL SERVICES CONTRACTS EXPLANATION
    Federal Government agencies are required to adhere to Federal 
Acquisition Regulations (FAR) when purchasing goods or services. FAR 
Part 37 is the section that addresses ``Service Contracting.''
    A service contract may be either a nonpersonal or personal services 
contract.
    The current contract that the Department of Homeland Security (DHS) 
has with A-TEK, Inc. is a nonpersonal services contract. The following 
definition of a nonpersonal services contract comes from the FAR, Part 
37.101: `` `Nonpersonal services contract' means a contract under which 
the personnel rendering the services are not subject, either by the 
contract's terms or by the manner of its administration, to the 
supervision and control usually prevailing in relationships between the 
Government and its employees.''
    For reference, the definition of a personal services contract, as 
written in FAR Part 37.104, is as follows: ``A personal services 
contract is characterized by the employer-employee relationship it 
creates between the Government and the contractor's personnel. The 
Government is normally required to obtain its employees by direct hire 
under competitive appointment or other procedures required by the civil 
service laws. Obtaining personal services by contract, rather than by 
direct hire, circumvents those laws unless Congress has specifically 
authorized acquisition of the services by contract.'' Here, the 
``Government'' refers to DHS and not the local or State laboratory 
directors or their designees. The services acquired in this case do not 
constitute personal services because Congress has not specifically 
authorized the acquisition of personal services by contract.
    Furthermore, Part 37.104 states that [Federal] ``Agencies shall not 
award personal services contracts unless specifically authorized by 
statute to do so.'' DHS has no authorization for a personal services 
contract to support the BioWatch Program.
    Since the DHS contract with A-TEK, Inc. (for the BioWatch Program) 
is a nonpersonal services contract, the following actions are 
prohibited:
   Personnel hiring/firing actions.--The Laboratory Directors 
        (or their designees) cannot hire or fire a Contractor's 
        employees. The Contractor is responsible for these employment 
        actions, as these employees are their personnel. If there are 
        any issues with Contractor employee conduct while hosted at the 
        laboratory's facility, it is incumbent upon the Laboratory 
        Director (or their designee) to inform DHS of these issues.
   Contractor internal matters.--The Laboratory Directors (or 
        their designees) cannot interfere with a Contractor's internal 
        matters (i.e., employee benefits, salaries, timesheet 
        authorization, etc.), particularly those associated with the 
        Contractor laboratory personnel. Under FAR regulations, DHS is 
        also prohibited from interfering with Contractor internal 
        matters.
   Contractor operations.--The Laboratory Directors (or their 
        designees) cannot dictate to the Contractor how the Contractor 
        should operate. Under FAR regulations, DHS is also prohibited 
        from dictating Contractor operations.
    Other matters:
   Contract labor issues.--The Laboratory Directors (or their 
        designees) cannot attempt to solve, or engender labor 
        irregularities. DHS' role is that of an impartial observer.
   Contractor work efforts.--The Laboratory Directors (or their 
        designees) cannot delay, or cause to be delayed, the 
        Contractor's work processes. Under FAR regulations, DHS is also 
        prohibited from delaying the Contractor's work processes.
   Contractor personnel behavior issues.--In the event 
        contractor personnel behavior constitutes an immediate danger 
        to themselves, other personnel, or facilities, or create a 
        workplace environment that is hostile (harassment) the 
        Laboratory Director may take such actions as necessary to 
        mitigate the risk, with subsequent notification to the 
        contractor and DHS. The contractor will then conduct an 
        investigation on the incident(s) and take such action as 
        necessary.
    Other notes: Justification for DHS obtaining a laboratory personnel 
services contract. DHS has a requirement for laboratory operations 
(including personnel) to ensure daily sample analysis is performed for 
the BioWatch Program. The performance of this work includes the 
operation of Government-owned equipment and systems.

    Mr. Langevin. Thank you, Dr. Downes, for your testimony.
    I want to thank all the witnesses for their testimony. I 
remind Members that he or she will have 5 minutes to question 
the panel. Before I go to questions, I just want to make 
reference to the fact that my partner in this effort, the 
Ranking Member of the subcommittee, Mr. McCaul, unfortunately, 
due to the late hour that we returned, has a conflict with 
another meeting, and will not be able to return, but asked that 
we continue in his absence.
    Let me begin with Mr. Hooks. This isn't the question I had 
intended to ask, but given Dr. Downes' testimony, it doesn't 
sound like BioWatch is being a very good partner in this case 
with the State and locals. Would you please respond to the 
testimony? How, if in this case the Michigan Department of 
Community Health in this case is not having a good experience, 
how are we going to expect other States and localities to want 
to participate if this is the way a, quote-unquote, partnership 
is working?
    Please respond.
    Mr. Hooks. Yes, Mr. Chairman.
    I point to some of Dr. Downes' testimony where she talked 
about a culture of partnership. I heartily agree that that is 
what the BioWatch program needs to be. It is a Federal-State-
local partnership, including the local laboratories.
    I am disappointed to be hearing the comments that she has 
provided. I am disappointed that I wasn't aware of the level of 
concern in the laboratory community since I have taken over 
this program. I am committed to resolving that.
    I have already offered to go visit with her and other 
appropriate officials to ensure that we create that level of 
partnership because I think, ultimately, our goal is the same, 
that we want to provide an early detection capability for the 
Nation that benefits the Nation.
    This isn't an issue of BioWatch, national program office, 
against the State, local community; and we need to look to 
create a value proposition that benefits both of our needs and 
our constraints.
    Mr. Langevin. Mr. Hooks, I know that you are relatively new 
in your current position, so I do want to turn to Dr. Stiefel 
as the program manager for BioWatch.
    Have you heard the concerns that Dr. Downes has raised, or 
is this news to you?
    Dr. Stiefel. No, no, not at all, sir. There have been 
concerns.
    One of the issues is, we just changed contractors. Whenever 
you change a contractor, there is always the--there is always 
turbulence when that occurs. We have heard about this. We have 
actually been taking actions with the contractor to try to 
ensure that the contractor performs up to the standards, talks 
to the lab directors about what has to happen.
    There are certain issues, because it is a contract, that 
are contractor employee-based, and as such, a contractor has to 
hire and fire the employee. But that is done and should be done 
through the lab director's advice and guidance. That is what we 
are trying to ensure. That is the way it was done over the 
previous contractor, when those employees converted from a CDC 
term hire to a contract. So these aren't new issues in the 
sense that we have been addressing them through the contractor.
    We also meet--have a conference call with the laboratory 
directors once a month, and these issues come up then. We 
haven't heard--we know there is concern out there, not to the 
extent that 28 laboratories have expressed that level of 
concern throughout the course of this contract revision.
    Mr. Langevin. What about the resource complaints, that we 
are not reimbursing for things that they consider to be 
priorities?
    Mr. Hooks. Sir, the current construct is the same as when 
the BioWatch program started. We expect to be paying for the 
personnel, the reagents, and the test equipment that are used 
to process BioWatch samples. We understand on the local 
laboratory side there are indirect costs associated with the 
space that is used for the BioWatch samples.
    It should be pointed out that from 2003 to 2008 the number 
of collectors that were being used in the jurisdiction that 
this laboratory was supporting increased by a figure of two--or 
actually, a figure of three, and so that is going to cause more 
samples to be analyzed. We expect to be able to cover the 
costs, those direct costs of the people, the reagents, and the 
test equipment for the laboratory. We are not asking them to 
take on that burden.
    So this clearly conveys that the communication needs to 
improve better with each of the laboratories so that they 
understand the position, where we have been. As appropriate, we 
need to revisit, is this the best relationship construct that 
is in place, since it is the same one that was put in place 
when the BioWatch system was stood up very quickly in a 90-day 
period back in 2003?
    Mr. Langevin. Given the seriousness of what I consider to 
be the biothreat and the fact that we need strong Federal, 
State, and local partners, I don't want to be doing this on the 
cheap. If we need to provide more resources, you have got to 
either provide them or speak up and say, you need more, and 
then the Congress has to do more in that area. But we can't 
obviously be doing this on the cheap, and then not having the 
State and locals feel that they aren't being supported and this 
isn't a good partnership.
    Dr. Downes, let me turn to you again. Would you care to 
respond to any of the things that you have heard in response to 
your testimony?
    Dr. Downes. One comment I would make is that the monthly 
calls with what DHS calls the ``BioWatch lab director'' is not 
someone in my role. It is not the person who is the 
administrator or the quality assurance regulatory lab director. 
They are more of what we call a section manager, or a smaller 
laboratory unit manager, and much more technical in nature. So 
they may not be conveying the resource issue as--because they 
are not responsible for the overall management of the 
laboratory the way that someone in my position is.
    I think that is a separate dialog that we need to open, as 
opposed to the technical discussions that have been on a 
monthly basis.
    Mr. Langevin. Very well. We will continue to follow this.
    Mr. Jenkins, do you care to respond to anything that you 
heard in the testimony?
    Mr. Jenkins. No, sir. We haven't looked at this particular 
issue that has been raised here and discussed here.
    Mr. Langevin. Okay.
    Let me just, before I turn to Ms. Christensen, I do have 
one question that I need to get to that is a priority. It is, 
currently the BioWatch system uses environmental sample 
collectors called Generation 1, Generation 2 detectors, as we 
have heard in testimony, that are collected once a day and 
analyzed in public health laboratories that are members of the 
Laboratory Response Network.
    Generation 3 detectors, which are automated and do not 
require physical chemical analysis at an LRN lab, are supposed 
to replace them, but that deployment keeps slipping. Obviously, 
the Generation 1 and Generation 2 detectors require a lot of 
human interaction. There are several hours--actually, several 
days of delay before we actually have results. I think it goes 
anywhere from 24 to 36 hours before we actually have results. 
Obviously the Generation 3 detectors are near real time, with 
very little to no human interaction required to get the results 
back, which obviously are more preferable. That is why we want 
to move in that direction.
    Clearly, we are not going fast enough as far as I am 
concerned. But the congressional justification for the fiscal 
year 2007 budget request submitted by the Science and 
Technology Directorate said that BioWatch would have fieldable 
prototypes in fiscal year 2007, and a Generation 3 BioWatch 
pilot in fiscal year 2008.
    Now, the fiscal year 2008 congressional justification 
submitted by the Office of Health Affairs called for, 
``operational testing of Generation 3 BioWatch monitoring 
systems, which are planned to begin in fiscal year 2008.'' In 
fiscal year 2009, the congressional justification submitted by 
Office of Health Affairs changed to--and again I quote--
``fiscal year 2009, which OHA plans a 6-month multicity 
operational test and evaluation of advanced automated 
technologies. This will allow Office of Health Affairs to 
advance to a full rate production procurement decision for 
advanced technology deployment in fiscal year 2010.''
    Now, finally, in testimony before the House Appropriations 
Committee on April 1, 2008, DHS Medical Officer Dr. Jeff Runge 
stated, quote again, that ``our target for that is April of 
2009 to do that head-to-head flyoff with whoever is ready, 
because we need to get technology ready, tested, thoroughly 
evaluated, boxes into the field, and to a large volume in 2010 
and 2011.''
    So we slipped from deployment, a deployed pilot in 2008, 
back to operational testing in 2009, and maybe to deploy some 
units in 2010 or 2011. This concerns me. I want to know why the 
deployment has been continually delayed. Were the projections 
too optimistic? Are you running into severe technical 
difficulties? Are the companies underperforming?
    We can start with those. Do you have, in fact, a drop-dead 
date where you either have a product ready or you rewrite your 
requirements and open the process?
    I am going to ask for comments both from Mr. Hooks and Mr. 
Stiefel, and I am going to ask for Mr. Jenkins to comment.
    Mr. Hooks. Sir, as the BioWatch program has matured and 
moving to look to Generation 3 technology from the Generation 1 
and 2 technology, as you discussed, getting into automated 
detection, technical requirements were written for that 
Generation 3 technology that were aggressive and probably 
appropriate requirements, trying to stretch the envelope of 
science and technology.
    But there is always a risk in technological development 
that the science breakthroughs won't come as fast or as regular 
as we would like and desire in a technology deployment. I 
think, over the period of time, as we have managed the program, 
we have looked at optimistically being able to field a 
technology earlier than was actually realistic.
    There is the balance point between--in the technology 
development that we ensure that we are looking far enough into 
the future of the technology we need to support the operations, 
so it is usable by the end-user community, such as the public 
health laboratory community, and at the same time managing the 
risk, to ensure we put the proper level of controls on that 
technology-development cycle--technical readiness assessments, 
test and evaluation procedures--at the same time trying to 
urgently get new technology out into the field. I think that 
has been the challenge, that some of the projections may have 
been over-optimistic.
    I think, as we are getting closer to the deployment of a 
Generation 3 technology and the Generation 2.5 technology, the 
plan always becomes more clear, because you are further down 
the technical maturity cycle of the technology, so you can 
gauge more carefully. There are fewer scientific breakthroughs 
and discoveries that are necessary.
    As you mentioned, Dr. Runge has said that the flyoff was 
scheduled for Generation 3 in April 2009. We are still on track 
for that. That is our plan, to fly off any technologies that 
meet the Generation 3 technologies, whether they have been 
developed within Science and Technology Directorate or are 
available on the commercial market. But it has already 
undergone a rigorous independent test and evaluation so we are 
not wasting time and money testing technologies that we know 
won't work.
    Mr. Langevin. Do you have a drop-dead date where you either 
have the product ready or you are going to rewrite the 
requirements and open the process?
    Mr. Hooks. Right now that is April 2009. I don't know that 
we would re-open the requirements process. We would look at 
that. It may be appropriate. If there is no technology that is 
ready to test as we are working through this cycle to 
Generation 3, then it would probably be more appropriate to 
delay, because we do need that level of automated technology.
    We do have units, we do have prototype automated technology 
units in place in New York City, an earlier version of a 
potential Gen-3 solution. That may be the trade-off decision. 
The reason we want to get to Generation 3 is because of the 
significantly lower cost of procurement and operation, as well 
as improved specificity to identify the pathogens of concern, 
as Mr. Jenkins has mentioned.
    That is important, and that is where we want to get. If we 
can't get there because our tests and evaluation and 
independent results convey that that is not possible, then we 
do need to look for an alternative interim solution to move 
forward and do the cost-benefit analysis on that.
    Mr. Langevin. Thank you.
    Mr. Stiefel, I would like you to comment on this, as well.
    Dr. Stiefel. Yes, sir. Actually, what Mr. Hooks said is 
exactly right. But there is another important component to this 
that we have to understand, and that is, whatever technology we 
field has to be good. It has to be trusted. It has to be 
public-health-actionable. So that when a signal comes in and it 
is considered a BioWatch-actionable result or a positive, that 
actions can be taken and the public health trusts that action.
    As Dr. Downes can rightly tell you, the current assays that 
we have are CDC, public-health-actionable assays. The systems 
that are in our Gen 2.5 system are public-health-actionable 
assays. So we can't afford to put a system out there that is 
going to make a mistake, because the actions of that mistake 
are tremendous, especially in large airport or other large 
transit facilities.
    So we need to get this right. Right now, April 2009, as Mr. 
Hooks says, is a good date. On the other hand, if technology 
didn't advance enough to be able to give us that system that we 
have full trust and confidence in that you would expect us to 
field, we potentially would have to slip. But at this point, we 
don't see that happening.
    Mr. Langevin. Thank you.
    Mr. Jenkins, do you have anything to add?
    Mr. Jenkins. I would make a couple of points here.
    One is that if there are issues with 3.0, in terms of 
slippage or whatever the issue is, as to what extent does 2.5 
help buy you time, the basic thing in 2.5 is that it detects 
the same number of agents that is currently being detected, it 
just automatically analyzes them.
    If there are no new assay tests developed, then the 3.0, 
when it is deployed, will still only detect the same number of 
agents that are currently being detected. It has, as I said--I 
was very careful in the wording--potentially the capability to 
detect all of those on the list. But until there is, as I said, 
the proved CDC assay test for these, they can't add those to 
the system.
    So, initially, it may be that the 3.0 only is detecting the 
same number the 2.0 is and 2.5 is. I think if there are issues 
here with regard to getting this right, the question is, what 
do I get in 2.5 and what do I not have that 3.0 will bring on? 
That is what we haven't really heard them talk about.
    Mr. Langevin. Mr. Stiefel, how would you respond to Mr. 
Jenkins on that point?
    Dr. Stiefel. What Generation 2.5 gives us today, because we 
are operational in New York City in a couple of venues, is 
getting that detection time down from 10 to 34 hours, because 
we collect for a 24-hour period of time, down to 4 to 6 hours. 
We actually collect every 2 hours, and then the assays run for 
2 hours while we are collecting for the next 2 hours.
    New York City will take full appropriate actions based on a 
positive from any one of those machines. That signal goes to 
the lab director. That is who makes that determination of a 
positive.
    What Gen 2.5 will give us is essentially most of the 
requirements in Gen 2.3 but not all of them. It doesn't give us 
the 30-day cycle to put more reagents into the machine instead 
of seven. It can go up well beyond the six agents, the five 
agents that we currently screen for. But, as Mr. Jenkins says, 
they have to be public-health-actionable CDC-approved assays.
    So 2.5 actually buys us significant time, but at the same 
cost, it is $40,000, $50,000, $60,000 more because we are 
making them in such limited numbers.
    Mr. Langevin. Thank you.
    Well, with that, I am going to turn to Ms. Christensen for 
her questions. Thank you for bearing with us, as we drill down 
a little bit on this.
    Mrs. Christensen. Thank you, Mr. Chairman.
    One of my questions referred to the automatic pathogen 
detection system also. So you are saying that--my question 
would have been, is that use a wise use of resources and a good 
way to bridge? But you are saying, yes, it is, because it 
covers the things that you have assays for.
    Mr. Hooks. Yes, ma'am. Going to automated detection is 
critical for our biosurveillance efforts for several reasons. 
One is it does reduce the time of detection on average right 
now by about 24 hours, which is critical to be able to respond 
earlier following a biological attack, that it be identified.
    Additionally, there are certain higher-risk venues, such as 
indoor facilities, where the current delay time on samples from 
an ability to detect in the 10 to 34 hours just does not work 
in the concept of operations. The cities have told us that they 
will not deploy the Generation 1 and 2 systems into those 
higher-risk venues, which are high through-put transportation 
environments such as subway systems or into airports and 
whatnot.
    Mrs. Christensen. From the time this committee was a select 
committee, we have always talked about having genetically 
altered or created pathogens. How far away are we from a point 
at which we can detect those kinds of pathogens that have never 
existed before or have been very much altered?
    Mr. Hooks. Genetically altered pathogens and other 
engineered threats are a concern to us. The technology is not 
there at this time to deploy into a BioWatch system. As we look 
forward to the future of a Generation 4 system, that is a key 
component that we need to be able to address in that.
    It is not clear to me if it is optimistic or realistic at 
this point, but our best guess is that is probably 3 to 5 years 
out. But please don't hold me to that.
    Mrs. Christensen. No, you have gotten into enough trouble 
over dates and deadlines here today.
    Mr. Hooks. Yes, ma'am.
    Mrs. Christensen. Back to the lab for a minute. Why is it 
necessary to have a contractor, an in-between person between 
you and the laboratory? Wouldn't be it just easier to contract 
with the labs directly?
    Mr. Hooks. I am going to defer that one to Mr. Stiefel.
    Dr. Stiefel. Actually, when the program first started--and 
it started so quickly--CDC put emergency hires in place through 
CDC, converted them over to temporary hires, term hires. It 
came to a point when CDC wanted to back away from that, because 
that was a large expense and these people were given no 
benefits. So we talked to the lab directors, and through CDC 
the only possible venue for us to go to, at that point, was to 
turn to a contracting scenario to put these laboratory 
personnel into the laboratory.
    We have also had requests from other labs and, for example, 
in Minnesota, where they have requested the possibility of 
putting State employees through a CDC grant or through some 
kind of grant. We have actually looked into that, and we have 
been looking into that for about a year. Many of the labs that 
I have spoken to would like that. The problem is that the 
States themselves are on hiring freezes, and even if we were to 
provide them money, they wouldn't have the ability to add these 
additional slots.
    So we are looking at lots of different ways in order to 
compensate: one, through contracting. Another one is 
potentially public health officers from HHS that could go into 
these laboratories. Another venue would be, wherever possible, 
to try to hire State employees through a COTPER grant with HHS 
and CDC.
    Mrs. Christensen. Dr. Downes, you may want to follow up on 
that question and answer. But I was also wondering, are the 
State of Michigan employees in the laboratory put at any risk 
because of the limitations imposed on you by the DHS BioWatch 
contract?
    Dr. Downes. We do treat those employees as if they are our 
own and require them to go through our safety training. Our 
concern is that, if we had somebody who was not performing to 
those standards, the fire safety program, that it would be--I 
have no mechanism at this point to dismiss that person 
immediately, for example. Or if the quality of their testing 
was not appropriate or they were disruptive in any sort of way 
within our facility, we would have no way to immediately take 
them out of the laboratory setting. So in that regard, they do 
potentially put our employees at risk.
    In regard to the contracting, direct contracting issue, I 
don't recall having a discussion in which we were given the 
option of directly contracting with DHS. I recall that it was 
not put on the table as an option.
    But, as Dr. Stiefel says, one contracting mechanism may not 
work in all States or local laboratories, and that having more 
of a portfolio of options would probably be the best and most 
direct way to accomplish achieving the through-put, as well as 
assuring quality and safety.
    Mrs. Christensen. Okay, thank you.
    Either Mr. Hooks or Dr. Stiefel, the January 17, 2008, 
letter from the Association of Public Health Laboratories that 
was sent to Assistant Secretary Runge, do you know if it has 
been responded to?
    It had outlined a number of concerns from member 
laboratories about personnel matters that developed with the 
award of the new BioWatch contract and suggested options for 
improvement.
    Has that been responded to yet?
    Mr. Hooks. That letter was in response to a meeting that 
was held with Dr. Runge, the Principal Deputy Assistant 
Secretary, and my predecessor in my present position, along 
with Dr. Stiefel. The larger content of that letter from 
January 17 was to address discussing a variety of preparedness 
issues and whatnot.
    There are, within there, paragraphs that mention that they 
were glad that they were able to discuss some of the issues 
that were on the table. From the reading of the letter, where 
it says, ``Thank you very much for the meeting,'' in reading 
the letter the Office of Health Affairs did not feel that it 
needed a response. It was not meant to be a snub of no 
response. The assumption was that the communication and dialog 
was continuing with a PHL.
    So the sense was this was a closure letter to a meeting, 
not raising larger issues. It mentioned moving forward: ``We 
reiterate our interest in working collaboratively.'' We 
completely concur and agree with that.
    Mrs. Christensen. Thank you.
    My last question is more of a process: How do you work? 
There was a well-reported detection of tularemia bacteria in 
the District of Columbia a few years ago, and it was eventually 
decided that it was a naturally occurring bacteria rather than 
a biological attack.
    I am a little more paranoid than most people. So everything 
to me, you know, all the food stuff, you know, I wonder.
    But how does the Department decide whether a positive test 
came from a naturally occurring event rather than a deliberate 
release? What are some of the factors that influence how 
quickly that determination is made?
    Mr. Hooks. So when a BioWatch signal comes up and it is 
determined to be a BioWatch-actionable result because there is 
nucleic acid on that filter that indicates that there is a 
pathogen--not a pathogen, but that there is nucleic acid that 
could be from that pathogen--the decision is made at the local 
laboratory by the laboratory director, such as Dr. Downes.
    In that case, there are procedures in place. At the 
national level, we have provided Federal guidance documents 
that discuss the preparedness, the response and the sampling 
for that event. There are very detailed procedures in place 
that have been put in place by each of the jurisdictions that 
we refer to as concept of operations.
    Each of the jurisdictions has a BioWatch Advisory 
Committee, which is made up of different people in the local 
community, including the public health director or their 
representative. There will be representatives from the mayor's 
office or other city officials, from the FBI, locals, other 
public health officials that come together. They analyze what 
that BioWatch-actionable result says and what it does 
potentially mean.
    They will look at a variety of different factors. The FBI 
will be looking: Is there intelligence information that would 
convey that we are at a higher risk of a potential attack? They 
will look at: Was it only detected on one collector or multiple 
collectors? That will give indication. They will look at the 
environmental conditions, as well. EPA is represented in this 
BioWatch Advisory Committee.
    To ensure that this works effectively, there is a normal 
protocol. We have a BioWatch exercise and evaluation program 
that is done annually with each of the jurisdictions, where we 
send out people from the national office that evaluate the 
protocols and procedures that are ongoing in each of the local 
jurisdictions to ensure that they do meet a high quality. 
Because, as mentioned previously, there are potential high-
regret actions that could be taken, and we don't want to ever 
get it wrong.
    Also, there are tabletop exercises that are done either 
under the auspices of the national office or certain 
jurisdictions choose to do them on their own. We will send 
representatives to assist in that.
    So this really is a partnership. We want to get it right 
every time.
    There have been 37 environmental positives where there was 
actually a detection of nucleic acid since the program has 
begun. In each of those cases, the local jurisdictions have 
walked through the protocols that are in place, executed, and 
determined that it did not cause a public health risk.
    We use those lessons learned from those events, from the 
tabletop exercises. Those are shared on a BioWatch portal to 
all of the jurisdictions so that we can learn from each other. 
They are briefed at the national conference every year to 
ensure that that information is passed, as well.
    Part of that is looking: How can we improve those 
procedures to be more efficient and effective, but still 
maintain that high level of quality necessary on a program of 
this type?
    Mrs. Christensen. So it is probably the intelligence side 
that helps to really make that determination or--well, I heard 
a couple of factors. Thank you.
    Thank you, Mr. Chairman.
    Mr. Langevin. I thank the gentlelady.
    Before I conclude the hearing, let me just say that I would 
ask that we all redouble our efforts on this issue of being 
better prepared for prevention, detection and response to 
potential biological threats, whether they be emerging threats 
from naturally occurring things or from man-made potential 
biological attacks.
    I take this issue very seriously. It truly concerns me. 
This subcommittee has jurisdiction over the Department's 
activities, and trying to prevent some of the scariest things, 
the things with the most devastating consequences that could 
face the country, whether dealing with a nuclear attack, 
preventing radiological attack, biological or chemical attack 
on the country.
    Clearly, of all the things, a nuclear attack would be very 
likely the most devastating. But, thankfully, Mother Nature 
didn't make it easy for us or anyone to acquire weapons-grade 
plutonium or highly enriched uranium. The same is not the case 
for biological attacks, which could possibly be just as 
catastrophic in terms of loss of life.
    The problem is, as experts have testified before this 
subcommittee before, someone with a basic degree in biology 
could cause a threat to public health. As technology 
proliferates and becomes more sophisticated and easy to 
acquire, especially those technologies that have dual-use 
technology, nebulizers and such, that are available on the open 
market, someone could cause real harm to the country through a 
biological attack and could cause massive loss of life. This 
keeps me up at night. We need to redouble our efforts to 
protect the country from these things.
    Clearly, and if someone does develop that capability, what 
concerns me, unlike in the unlikely event of a nuclear attack, 
people would be able to do this biological attack again and 
again and again. We can't ever allow that to happen.
    I want to thank our witnesses for their efforts and their 
testimony.
    Again, I want to thank Ms. Christensen for her patience and 
staying through this second hearing, as well as our witnesses.
    The Members of the subcommittee may have additional 
questions for the witnesses that we will ask that you respond 
expeditiously in writing.
    Having no further business, the subcommittee now stands 
adjourned.
    [Whereupon, at 6:06 p.m., the subcommittee was adjourned.]

                                 
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