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