[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]
CREATING A NATIONWIDE INTEGRATED BIOSURVEILLANCE NETWORK
=======================================================================
HEARING
before the
SUBCOMMITTEE ON PREVENTION OF
NUCLEAR AND BIOLOGICAL ATTACK
of the
COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
MAY 11, 2006
__________
Serial No. 109-76
__________
Printed for the use of the Committee on Homeland Security
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Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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Committee on Homeland Security
Peter T. King, New York, Chairman
Don Young, Alaska Bennie G. Thompson, Mississippi
Lamar S. Smith, Texas Loretta Sanchez, California
Curt Weldon, Pennsylvania Edward J. Markey, Massachusetts
Christopher Shays, Connecticut Norman D. Dicks, Washington
John Linder, Georgia 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
Jim Gibbons, Nevada Columbia
Rob Simmons, Connecticut Zoe Lofgren, California
Mike Rogers, Alabama Sheila Jackson-Lee, Texas
Stevan Pearce, New Mexico Bill Pascrell, Jr., New Jersey
Katherine Harris, Florida Donna M. Christensen, U.S. Virgin
Bobby Jindal, Louisiana Islands
Dave G. Reichert, Washington Bob Etheridge, North Carolina
Michael McCaul, Texas James R. Langevin, Rhode Island
Charlie Dent, Pennsylvania Kendrick B. Meek, Florida
Ginny Brown-Waite, Florida
______
SUBCOMMITTEE ON PREVENTION OF NUCLEAR AND BIOLOGICAL ATTACK
John Linder, Georgia, Chairman
Don Young, Alaska James R. Langevin, Rhode Island
Christopher Shays, Connecticut EdwarD J. Markey, Massachusetts
Daniel E. Lungren, California Norman D. Dicks, Washington
Jim Gibbons, Nevada Jane Harman, California
Rob Simmons, Connecticut Eleanor Holmes Norton, District of
Bobby Jindal, Louisiana Columbia
Charlie Dent, Pennsylvania Donna M. Christensen, U.S. Virgin
Peter T. King, New York (Ex Islands
Officio) Bennie G. Thompson, Mississippi
(Ex Officio)
(II)
C O N T E N T S
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Page
STATEMENTS
The Honorable John Linder, a Representative in Congress From the
State of Georgia, and Chairman, Subcommittee on Prevention of
Nuclear and Biological Attack.................................. 1
The Honorable James R. Langevin, a Representative in Congress
From the State of Rhode Island, and Ranking Member,
Subcommittee on Prevention of Nuclear and Biological Attack.... 2
The Honorable Donna M. Christensen, a Delegate in Congress From
the Virgin Islands............................................. 36
The Honorable Norman D. Dicks, a Representative in Congress From
the State of Washinton......................................... 37
The Honorable Jim Gibbons, a Representative in Congress From the
State of Nevada................................................ 34
WITNESSES
Dr. Rich Besser, Director, Coordinating Office of Terrorism,
Preparedness and Emergency Response, Centers for Disease
Control and Prevention:
Oral Statement................................................. 15
Prepared Statement............................................. 17
Dr. John Clifford, Deputy Administrator for Veterinary Services,
Animal and Plant Health Inspection Services, Department of
Agriculture:
Oral Statement................................................. 25
Prepared Statment.............................................. 26
Ms. Ellen Embrey, Deputy Assistant Secretary of Defense for Force
Health Protection and Readiness:
Oral Statement................................................. 22
Prepared Statement............................................. 23
Dr. Kimothy Smith, Chief Veterinarian, Chief Scientist, and
Acting Deputy Chief Medical Officer, Department of Homeland
Security:
Oral Statement................................................. 3
Prepared Statement............................................. 5
Dr. John Vitko, Director of Biological Countermeasures,
Department of Homeland Security:
Oral Statement................................................. 8
Prepared Statement............................................. 10
CREATING A NATIONWIDE INTEGRATED BIOSURVEILLANCE NETWORK
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Thursday, May 11, 2006
U.S. House of Representatives,
Committee on Homeland Security
Subcommittee on Prevention of
Nuclear and Biological Attack,
Washington, DC.
The subcommittee met, pursuant to call, at 2:07 p.m., in
Room 1310, Longworth House Office Building, Hon. John Linder
[chairman of the subcommittee] presiding.
Present: Representatives Linder, Gibbons, Dent, Lungren,
Langevin, Dicks, and Christensen.
Mr. Linder. [Presiding.] The Committee on Homeland
Security's Subcommittee on Prevention of Nuclear and Biological
Attack will come to order.
The subcommittee is meeting today to hear the testimony on
creating a nationwide integrated biosurveillance network.
I want to thank our distinguished panel of witnesses for
being here today.
Last week, the subcommittee heard from members of the
Intelligence Committee on how they were engaging the bioscience
community to enhance our understanding of biological threats.
What we learned from that hearing is that the U.S. needs to
create a community of thinkers that bring together the skills
of both bioscientists and intelligence experts to better
determine the threat of a biological attack on the United
States.
In 2004, President Bush unveiled his strategy on biodefense
for the 21st century, an important part of which is creating a
state-of-the-art biosurveillance system. Leading this charge is
the Department of Homeland Security's effort to develop a
national biosurveillance integration system.
This new system is intended to be the central point for
collection, analysis and dissemination of 30 different sources
of aggregated data from 10 different government agencies, to
provide a one-stop shop for biosurveillance information.
That information can be linked with current intelligence
and be used to provide situational awareness reports to all
levels of government, to help respond more quickly and
effectively to prevent or contain the spread of disease and
save countless lives.
Today, I hope to receive an update on the national
biosurveillance integration system at DHS, as well as a status
check on some of the major data that feeds into the system,
including the BioSense Program at CDC, the BioWatch
environmental detection system coordinated by DHS, the ESSENCE
surveillance system at the DOD, and the multiple animal and
plant health surveillance efforts at USDA.
While all the experts and agencies here today form a major
part of the community of thinkers, I know that each agency has
its own challenges in trying to integrate with each other. The
importance of this capability, though, cannot be overstated.
The possibility of an influenza pandemic, for example,
demonstrates why we need this capability now, from the USDA's
initial identification of H5N1 to the CDC's use of the BioSense
system, to tracking the cases, to DHS's coordination with state
and local officials. They all need to be at the same table to
effectively monitor any outbreak in the United States and
prevent its spread. We simply cannot afford the costs that will
come with a delay.
As such, I look forward to our witnesses' testimony on the
current status and challenges they face in ensuring that such a
scenario does not become a reality.
I now recognize my friend from Rhode Island, Mr. Langevin,
for the purpose of making an opening statement.
Mr. Langevin. Thank you, Mr. Chairman.
I would like to take this opportunity to thank our
witnesses for being here today.
The subcommittee has seen the usefulness and importance of
bio-intelligence. Last week, we met, as the chairman mentioned,
with the intelligence community to hear about their efforts to
incorporate bio-intelligence into their work.
Biosurveillance is an important piece of the puzzle to
obtain useful bio-intelligence. I thank the chairman for
holding this hearing today.
Each of your agencies has developed biosurveillance
capabilities for different reasons and particular purposes. At
the Department of Agriculture, it is primarily for the
protection of domestic livestock and crops from both endemic
and foreign-born diseases. For the Department of Defense, force
protection is the motivator. The Centers for Disease Control
aims to stop the spread of naturally occurring disease, and the
Department of Homeland Security's goal is to protect us against
bioterrorism.
Because of the nature of disease, bioterror attack may be
indistinguishable from a natural outbreak. An outbreak in
animals can spread to humans and the battlelines will not be as
well defined as they are in traditional wars. Your missions are
becoming more similar, and we have to take into account all
aspects of the problem if we are to achieve a nationwide
capability.
One likely scenario we will face is pandemic influenza. The
administration has determined that a 1918-type epidemic could
kill approximately two million Americans. We must do everything
possible to prevent such an outbreak, and early detection
tracking will be extremely important.
We all have a role to play, and I am very interested in the
programs that you are engaged in now, how they work together,
and how we can improve them. We need to make sure that your
efforts are coordinated and that we are not duplicating
programs or leaving gaps in coverage. I also serve on the House
Armed Services Committee. There are many areas where the
military has developed programs that could be adapted to
civilian use.
I believe we can all benefit from sharing information,
adapting ideas that were developed in the military to civilian
use and creating joint military-civilian programs. I look
forward to hearing about the programs that we can adapt in the
capabilities and limitations, and most importantly, what
procedures are and should be followed, both before and after a
detection event.
It is important that we coordinate who is doing what and
how the information is assembled and analyzed in order to spot
problems, mitigate damage, and effectively protect the health
of our citizens.
So I look forward to the witnesses' testimony, and I yield
back.
Thank you, Mr. Chairman.
Mr. Linder. I thank the gentleman.
We are pleased to have before us a distinguished panel of
witnesses on this important topic.
Let me remind the witnesses that their entire written
statement will appear in the record. We ask, however, that all
witnesses make an effort to limit their testimony to no more
than 5 minutes.
Dr. Kimothy Smith is the chief veterinarian and social-
medical officer for operations and response at DHS, and is one
of the nation's foremost experts on anthrax infection.
Dr. John Vitko returns to us from the DHS. He is currently
director of biological countermeasures at DHS, and oversees the
biologic program. He comes to DHS from the Sandia National
Laboratory, where he led a major portion of Sandia's strategic
defense programs.
Dr. Rich Besser is from the CDC, the director of the
Coordinating Office of Terrorism Preparedness and Emergency
Response at CDC in Atlanta. He is a former epidemic
intelligence service officer and is now tasked with managing
CDC's nearly $1.7 billion terrorism preparedness and response
budget.
Ms. Ellen Embrey from the DOD is the director of force
health protection and readiness and director of deployment
health support at the Department of Defense. She has held
various senior executive positions at the Department of
Defense, including acting as assistant secretary of defense for
reserve affairs.
And finally, Dr. John Clifford is the deputy administrator
for USDA's Animal and Plant Health Inspection Service's
Veterinary Services Program. He has extensive experience in the
veterinarian medicine field, including being the veterinarian
in charge in Ohio, West Virginia, Michigan and Indiana.
Dr. Smith, please begin.
STATEMENT OF DR. KIMOTHY SMITH, CHIEF VETERINARIAN, CHIEF
SCIENTIST, AND ACTING DEPUTY CHIEF MEDICAL OFFICER, DEPARTMENT
OF HOMELAND SECURITY
Dr. Smith. Mr. Chairman, Ranking Member Langevin and
members of the subcommittee, I am Kimothy Smith, chief
veterinarian and acting deputy chief medical officer for the
Department of Homeland Security. I appreciate this opportunity
to discuss with you the national biosurveillance integration
system, NBIS.
I will briefly discuss with you the vision for the NBIS,
the relationships and functions which the NBIS requires and
exploits, as well as the integrated biosurveillance situational
awareness output. I will present for you the challenges as we
perceive them, review the current state of NBIS development,
discuss the next steps in the development of the system, and
respectfully answer your questions should you have any.
The Department of Homeland Security leads the NBIS program.
The program began in fiscal year 2005 and has the purpose of
integrating and fusing biosurveillance information streams from
food, agriculture, public health, environmental monitoring, and
intelligence. NBIS was conceived to provide continuous
situational awareness, early warning of a possible attack, and
a decision support system for event response in the event of a
biological incident, whether intentional or naturally
occurring.
My colleagues here with me can give you a more
comprehensive and detailed description of biosurveillance
information streams as the visual aid that you have with you
before you, but a few examples of these are the BioWatch
program, the food emergency response network, the electronic
surveillance system of the early notification of community-
based epidemics, the emergency management response system used
by the veterinary services of the Department of Agriculture,
and BioSense, which has information being collected by the
Centers for Disease Control and Prevention.
However, NBIS is more than an information technology
solution to the nation's integrated biosurveillance challenge.
In fact, NBIS can be viewed as having three vital component
parts: a robust information management system; a corps of
skilled subject-matter experts; and an established culture of
trust, cooperation and mutual support.
Simply put, the heart of NBIS is relationships between
people and the agents and organizations that they represent.
These relationships will work to develop a culture of trust
which, in turn, will facilitate information sharing and will be
vital to obtain access to valuable, often sensitive and
sometimes classified information being collected and use by the
NBIS partners.
Threat stream information will be provided through a
primary NBIS partner, the Department of Homeland Security
Office of Intelligence and Analysis. Once biosurveillance
information is fused with threat information, the completed
product will be provided to the Homeland Security Operations
Center for inclusion in the common operating picture. The
common operating picture will provide near real-time streams of
biosurveillance situational awareness product, back to the NBIS
partner agencies and organizations continuously.
The NBIS program is faced with three areas of challenge
today. A robust information management system is required that
must be capable of receiving large quantities of diverse
information, structure that information into a standard format,
and prepare it for fusion with information from all other
sources. NBIS will need staff from our partner agencies that
are the best and brightest in their area of expertise,
dedicated to participation within the NBIS program.
The competition for these minds is fierce, and it will be
incumbent upon the Department of Homeland Security to
demonstrate persuasively to its partners that there is
substantial benefit to participation. NBIS must personify a
culture of trust among our partners in order to allow the
sharing of sensitive information that in some cases is
unprecedented between agencies and organizations.
Safeguards must be built into processes, and become second-
nature to personnel to ensure that the information that is
provided to NBIS, along with any resulting interpretations,
patterns and trend information, will not be misinterpreted,
mishandled or inappropriately released.
The situational awareness product developed by NBIS must be
of sufficiently high quality to represent an added value to the
information contributors and equal a total that is
substantially more than the sum of its independent parts. A
pilot information system for NBIS has been established and is
functional. The system has provided some operational capability
and many insights into the challenges of near-real-time
biosurveillance situational awareness.
NBIS currently has a small staff with medical, biological
and operational expertise and a limited ability for reach-back
to additional subject-matter experts. NBIS is producing daily
situational awareness products and weekly situational reports
for circulation internal to the Department of Homeland
Security, a small number of interagency partners, and the
Homeland Security Council.
There is a draft request for proposals out now for
information system implementation of NBIS and I anticipate that
the contract will be awarded by mid-summer. Once selection of
this contract performer has been made, the full implementation
of NBIS will begin, and I anticipate rapid progress toward
first functionality in 6 months after reward of the contract.
In closing, I would like to say that the national
biosurveillance integration system is a top priority initiative
for the Department of Homeland Security. Our job is to ensure
that the nation has the capability for comprehensive integrated
biosurveillance situational awareness.
Thank you once again for allowing me to speak to you. I
will gladly answer any questions that you might have.
[The statement of Dr. Smith follows:]
For the Record
Prepared Statement of Dr. Kimothy Smith
INTRODUCTION
Mr. Chairman and Ranking Member Langevin and members of the Sub-
Committee, I am Kimothy Smith, Chief Veterinarian and Acting Deputy
Chief Medical Officer for the Department of Homeland Security. I
appreciate this opportunity to discuss with you the National Bio-
surveillance Integration System (NBIS).
The Department of Homeland Security is leading the NBIS program, an
effort to develop an integrated and comprehensive bio-surveillance
system which will answer the President's call for a `timely response to
mitigate the consequences of a biological weapons attack'. The
Department of Homeland Security Preparedness Directorate has
responsibility for the execution of this national interagency effort.
The National Bio-surveillance Integration System will be the nation's
first capability for comprehensive, integrated bio-surveillance
situational awareness.
In this presentation I will explain the vision for the NBIS and its
relevance to a wide range of federal agencies, state and local
government, tribal authorities and the private sector. I will describe
the relationships and functions which the National Bio-surveillance
Integration System requires and exploits, as well as the results--the
patterns and trends of a comprehensive integrated bio-surveillance
situational awareness product as part of a National Common Operating
Picture. I will present for you the challenges as we perceive them
today and review the current state of NBIS development. Finally, I will
present the `next steps' in the development of the System and
respectfully answer your questions if you have any.
VISION
The National Biosurveillance Integration System program was begun
in FY05 for the purpose of integrating and fusing biosurveillance
information streams from food, agricultural, public health,
environmental monitoring and intelligence community from federal,
state, private and international sources to provide continuous
situational awareness, early warning of a possible attack, and a
decision support system for outbreak and event response in the event of
a biological incident whether intentional or naturally occurring. It is
essential that I convey to you that NBIS is more than an information
technology solution to the nation's integrated bio-surveillance
challenge. The three vital component parts of the NBIS will be a robust
information management system capable of handling large quantities of
structured and unstructured information; a corps of specially skilled
subject matter experts; and, the establishment of a culture of
cooperation and mutual support within a our interagency (and other)
partners . The heart of NBIS is relationships between people and the
agencies and organizations they represent.
NBIS will have relationships with and personnel from a wide variety
of federal agencies and other entities including the Department of the
Interior, Department of State, United States Department of Agriculture,
Department of Defense, Department of Health and Human Services and its
operating divisions, the Centers For Disease Control and Prevention and
the Food and Drug Administration, and the Department of Veterans
Affairs. Trusted relationships will also be established with state and
local entities, civil and defense authorities, and with law
enforcement, science, academia, health, and commercial sources (amongst
others).
The purpose of the relationships which the NBIS will develop is to
create a culture of trust which facilitates information sharing. The
information acquired from a wide range of trusted partners will be
`fused' within the NBIS and subjected to interpretation and modeling
algorithms. Subject matter experts from the various agencies and
organizations will examine the collected and fused information
providing informed interpretation, iterative modeling examinations and
request reach-back consultations and queries when appropriate.
Fused information products, patterns and trends deduced and
interpreted from bio-surveillance sources, will be provided to a
primary NBIS partner, the DHS Office of Intelligence and Analysis
(OI&A) for incorporation with intelligence analysis products. When
appropriate the product can be forwarded to the wider Intelligence
Community and pertinent threat analysis information then returned back
to NBIS. The information can also be forwarded to the Homeland
Infrastructure Threat and Risk Analysis Center (HITRAC) to inform
critical infrastructure and key resource private sector partners. A
two-way connection will be maintained between the NBIS, the Office of
Intelligence and Analysis and the Intelligence Community since fused
information will flow out, and intelligence assessments and analyses
will flow back.
The final process of actionable information preparation fuses bio-
surveillance patterns and trends with threat information. The completed
product will be provided to the Homeland Security Operations Center for
inclusion in the Common Operating Picture (COP). The Common Operating
Picture is distributed via the Homeland Security Information Network
(HSIN). This distribution closes the loop by providing near real-time
streams of bio-surveillance situational awareness product back to NBIS
partner agencies and organizations.
The National Bio-surveillance Integration System will leverage
information sources from NBIS partner agencies and organizations as
well as all available open-source information. Going back to the heart
of NBIS, the trusted relationships developed with personnel, agencies
and organizations will be vital to obtain access to the valuable, often
sensitive and sometimes classified information collected and used by
the NBIS partners. Information sources include environmental sampling
information, for instance Project BioWatch which conducts aerosol
monitoring for biothreat agents in metropolitan areas; human health
surveillance (e.g. BioSense which reports syndromic surveillance
information from hospitals, clinics, pharmacies, and other sources),
animal health and food surveillance such as the Electronic Laboratory
Exchange Network and diagnostic results collected through the National
Animal Health Laboratory Network, plant health sources as those
provided through the National Plant Diagnostic Network, open-source
technical, medical, veterinary and non-governmental organization
reporting as well as mainstream media sources. In order to obtain the
necessary technical expertise, MOUs with partnering agencies will be
developed.
By integrating and fusing this large amount of available
information we can begin to develop a base-line or background against
which we can recognize anomalies and changes of significance indicating
potential biological events whether naturally occurring or from
malicious intent.
The near real-time patterns and trends outputs of the NBIS, in
combination with the threat streams analysis products for wide
distribution via the Homeland Security Information Network (HSIN)
realize the situational awareness mission solution-set envisaged in the
President's `Bio-defense for the 21st Century'. There are significant
challenges to overcome, nevertheless.
CHALLENGES
I perceive several notable challenges to achieve this vision of a
successful National Bio-Surveillance Integration System.
We recognize that a robust information management system is
required. I use ``robust'' to indicate that the system must be capable
of receiving large quantities of diverse information, structure that
information into a standard format. Information will be sent to NBIS
from many sources including federal, state, and local entities; both
from civil and defense authorities; and from law enforcement, science,
scholarship, health, and commercial sources. NBIS will accept such
information from all sources, regardless of format, standardize the
information, and prepare it for ``fusion'' with information from all
other sources.
The information management system must enforce access controls for
the inherently valuable, often sensitive and sometimes classified
information being collected. These controls will be flexible enough to
provide ``need to know'' access to appropriate users with the NBIS team
members. NBIS will employ ``state of the market'' interpretive
information analysis systems including automatic cataloging and pattern
recognition software but will likely require development of unique
algorithms for modeling and interpretation by the NBIS staff.
The NBIS will be a work environment for the best and brightest of
all the participating agencies and organizations. Highly skilled and
suitably trained subject matter experts must characterize the workforce
employed in this dynamic, cross-functional, multi-disciplinary
actionable information generating facility. In addition to holding
skills important to home agencies such as research, scholarship,
military science, intelligence, public health, and so on, analysts at
NBIS must be familiar with the disciplines of their co-workers, and
must also understand the nature of the information captured by the
system, and have the capacity to operate information-merging and fusion
applications to yield informed, useful, and actionable products.
NBIS team members must be able to interpret information and make
deductions from analysis algorithms, and to ascribe an accurate level
of confidence in their findings.
NBIS must personify a culture of trust among our interagency,
private sector and government partners in order to be successful. Along
with the development of relationships mentioned previously will be the
development of this culture of trust to allow the sharing of sensitive
information that in some cases is unprecedented between agencies and
organizations. A respect and appreciation for these sensitivities,
handling restriction and precautions must be demonstrated and a track-
record established. Safeguards must be built into processes and become
second-nature to personnel to ensure that information that is provided
to NBIS along with resulting interpretations, patterns and trend
information will not be misinterpreted, mishandled or inappropriately
released.
The situational awareness product developed by NBIS must be of
sufficiently high quality to represent an added-value to the
information contributors and equal a total that is substantially more
than the sum of its independent parts. If there is no daily relevancy
to the missions of the individual agencies, they will be reluctant to
share information collected by their bio-surveillance activities and
will not participate as an NBIS partner.
CURRENT STATE
A pilot NBIS Information Management System has been established and
is functional as of this calendar year. This system has provided some
operational capability and many insights into the challenges of near-
real-time bio-surveillance situational awareness, particularly for
avian influenza. NBIS is producing daily situational awareness products
and weekly situational reports for circulation internal to the
Department of Homeland Security, a small number of interagency partners
and the Homeland Security Council.
The pilot NBIS information management system has also provided a
test-bed environment to further understand the requirements for the
full robust information management system that is required for NBIS. An
in-depth study defining the information and technical system
architecture requirements for full NBIS functionality has been
completed. This study has guided the request for proposals for
implementation of the NBIS information management system and the draft
Request for Proposals has been issued. If the current procurement
schedule remains intact, I anticipate that the contract for this will
be awarded mid-summer.
NBIS currently has a small staff with medical, biological and
operational expertise and a limited ability for reach-back to
additional subject matter experts, some of whom are interagency and
interdepartmental. NBIS has one detailee onboard from the National
Geospatial Intelligence Agency and expects to have a second detailee
from the Department of Defense Northern Command very soon. NBIS
operations are currently being staffed 24 hours 7 days per week. The
NBIS is staffed at approximately 20% of the anticipated total personnel
that will be needed when we are fully operational.
We continue to work to develop an ethos of trust and to educate
both ourselves and our partners to optimize the potential of the NBIS.
We are working hard to identify the needs and requirements of future
NBIS participants and to demonstrate to both existing and candidate
mission-partners the benefits NBIS can provide. Partnerships between
the Department of Homeland Security National Bio-surveillance
Integration System staff and Health and Human Services/Centers for
Disease Control, the Department of Defense, United States Department of
Agriculture, Department of the Interior and Department of State are
being cultivated as the initial high importance participants in NBIS.
NEXT STEPS
As I have already mentioned there is a draft Request for Proposals
out now for the information system implementation of NBIS we anticipate
that the contract will be awarded by mid-summer. Once the selection of
a contract performer has been made, the full implementation of NBIS
will begin and I anticipate rapid progress toward functionality with
first functionality of the full NBIS Information Management System
approximately 6 months after the award of contract.
The partnerships we are developing will increase the interagency
NBIS staff of subject matter experts during the summer and fall of 2006
and we anticipate a full complement of personnel as the system is
brought to first functionality.
In closing, I would like to say that the National Bio-surveillance
Integration System is a top-priority initiative for the Department of
Homeland Security. Our job is to ensure that the nation has the
capability for comprehensive, integrated bio-surveillance situational
awareness, early warning of a possible attack and a decision support
system for outbreak and event response in the event of a biological
incident whether intentional or naturally occurring.
Mr. Linder. Thank you, Dr. Smith.
Dr. Vitko?
STATEMENT OF DR. JOHN VITKO, DIRECTOR OF BIOLOGICAL
COUNTERMEASURES, DEPARTMENT OF HOMELAND SECURITY
Dr. Vitko. Good afternoon, Chairman Linder and Ranking
Member Langevin and members of the subcommittee. I am pleased
to appear before you today to discuss the roles of the Science
and Technology Directorate of the Department of Homeland
Security in creating a nationwide integrated biosurveillance
network.
Recognizing that early warning of biological attack is an
essential component of biodefense, both the president and
Congress have directed the nation to develop an integrated and
comprehensive attack warning system to rapidly recognize and
characterize the dispersal of biological agents in human and
animal populations, food, water, agriculture and the
environment.
The biological countermeasures portfolio in DHS S&T has
been a leader in fulfilling these responsibilities. We devote
approximately one-half our annual resources to fielding and
operating biodetection systems and developing the technologies
to improve them. To date, we have provided the nation with its
first operational bioaerosol monitoring capability, a system
known as BioWatch.
We continue to improve that system, introducing new
technologies to significantly increase its capabilities and to
lower its costs, thereby allowing us to extend it to greater
coverage for the nation. We have established an interagency
memorandum of understanding to guide the development of a
nationally coordinated biodetection system, and we are
developing food contamination and agriculture outbreak
detection systems to greatly improve surveillance capabilities
in those sectors.
The information provided by these systems will be important
feeds into the NBIS system you have just heard about. Let me
briefly describe some of these accomplishments.
In early 2003, DHS, in partnership with the EPA and CDC,
deployed a BioWatch environmental monitoring system to protect
our nation's cities from the threats and ramifications of
bioterrorist attack. Because of the heightened tensions at that
time, this first-generation system was deployed in an amazingly
short 90 days. Gen 1 BioWatch uses air samplers distributed
throughout a city, with filters retrieved daily or more
frequently, and brought to a nearby laboratory response
network, LRN laboratory, for genetic analysis.
This system has been operating for more than 3 years and
has performed more than 2.5 million assays to date without a
false positive. We are now in the midst of enhancing that
system, an enhancement we call Gen 2, by increasing the number
of collectors in the top-threat cities three-to four-fold,
thereby decreasing the minimum attack size that we can detect,
and providing added protection for transportation hubs and
other critical facilities.
The Gen1 and Gen 1 BioWatch operational costs are dominated
by labor costs for retrieving and analyzing filters. These
costs limit the number of collectors we can deploy and the
frequency with which we can collect them. To overcome these
limitations and therefore greatly expand the population monitor
by BioWatch, we are developing fully automated detection
systems that analyze the air samples at the site at which they
are collected and wirelessly transmit the results to an LRN.
Field prototypes of these autonomous detectors will be
available in 2007, piloted in 2008, and be in deployment in
BioWatch cities in 2009.
We are also developing a biological warning and incident
characterization system called BWIC to assist local decision-
makers in determining the public health significance of any
BioWatch positive and also to assist in reconstructing the
event to guide the response. To accomplish this, BWIC
integrates BioWatch data with plume and disease modeling, and
with medical surveillance, for example, from the CDC BioSense
program, to provide an improved understanding about the
possible origin and extent of the release, and some estimates
of its impact. BWIC is currently being piloted in Chicago and
Miami.
S&T has also taken several major steps to better coordinate
the growing number of interagency biomonitoring and
biodetection activities. Jointly with the DOD, we recently
completed a program known as BioNet that successfully piloted a
coordinated civilian and military concept of operation for
biodetection and characterization in the San Diego, California
area. We led the development and implementation of an
interagency MOU on coordinated biomonitoring of biological
threat agents, which calls for coordinated architecture, rapid
notification of all parties in the case of a confirmed
positive, and a process for establishing equivalency among the
assays used by the parties to the MOU.
We are also a leader in the applied R&D needed to develop
the next generation of technologies to improve these
capabilities. We are developing fully autonomous detection
systems that will greatly lower the operational costs of
BioWatch. We are developing rapid detection systems that can
act as a bio smoke alarm for protecting special facilities and
event. We are working with the FDA to develop food sensors that
could detect the presence of bio agents at central food
processing plants prior to the product entering the food
distribution stream. And we are working with the USDA to
develop high through-put diagnostics to rapidly characterize
and contain outbreaks of foreign animal diseases.
In summary, DHS S&T has taken very seriously its
responsibilities to the nation, our president and our Congress,
to be a leader in creating a nationwide integrated
biosurveillance network.
Chairman Linder, Ranking Member Langevin and distinguished
members of the subcommittee, I thank you for the opportunity to
speak before you, and I am happy to answer any questions when
the time comes. Thank you.
[The statement of Dr. Vitko follows:]
For the Record
Prepared Statement of Dr. John Vitko, Jr.
INTRODUCTION
Good afternoon, Chairman Linder, Ranking Member Langevin, and
distinguished members of the Committee. I am pleased to appear before
you today to discuss the role of the Science and Technology Directorate
(S&T) of the Department of Homeland Security (DHS) in ``Creating a
Nation-wide, Integrated Biosurveillance Network''.
The importance of this activity and DHS' role in it are clearly
called out in the President's Biodefense for the 21st Century, which
states that: ``Early warning, detection, or recognition of biological
weapons attacks to permit a timely response to mitigate their
consequences is an essential component of biodefense. Through the
President's recently proposed biosurveillance initiative, the United
States is working to develop an integrated and comprehensive attack
warning system to rapidly recognize and characterize the dispersal of
biological agents in human and animal populations, food, water,
agriculture, and the environment. . . .The Department of Homeland
Security, in coordination with other appropriate Federal departments
and agencies, integrates these efforts.''
The Biological Countermeasures Portfolio in DHS S&T has been a
leader in fulfilling these responsibilities, devoting approximately
half our annual resources to fielding and operating biodetection
systems and developing the technologies to improve them. To date, we:
Have provided the Nation with its first operational
bioaerosol monitoring capability;
continue to improve that system, introducing new
technologies to significantly increase its capabilities and to
lower its costs thereby allowing us to extend coverage to
greater parts of the Nation;.
are working with our partnering agencies to develop a
nationally coordinated Biomonitoring system; and
are developing food contamination and agricultural
outbreak detection systems to greatly improve surveillance
capabilities in those sectors.
In addition, we collaborate and support our interagency colleagues
in those biosurveillance areas where they have the lead: e.g. Health
and Human Services (HHS) on human health surveillance; United States
Department of Agriculture (USDA) on agricultural surveillance; HHS and
USDA on food surveillance; and the Environmental Protection Agency
(EPA) on water surveillance.
As important and powerful as each of these individual
biosurveillance data streams are, they are even much more powerful when
integrated to form a common biological operating picture. In its FY2005
Appropriations, Congress assigned the responsibility for integrating
these information streams on the state-of-health of people, animals and
plants, with environmental monitoring of air, food, and water and with
real-time threat information to what is now the DHS Preparedness
Directorate and my colleague Dr. Kimothy Smith will summarize those
efforts in a separate testimony in this hearing.
For today, I will focus my comments on those areas in which DHS S&T
has a lead role.
BIOWATCH
BioWatch is an environmental monitoring system to help provide the
earliest possible warning of a biological attack and hence speed the
deployment and administration of medical countermeasures to mitigate
the effects of such an attack. It is led and funded by DHS and operated
in close partnership with the Centers for Disease Control and
Prevention (CDC), the EPA and the Federal Bureau of Investigation
(FBI). From the outset, the plan has been to field an early operational
capability and to then deploy successive generations of technology to
improve this capability. These successive generations are referred to
as Gen 1, Gen 2 and Gen 3 BioWatch.
Gen 1: This first generation system was deployed in early 2003 and
uses air samplers distributed throughout a city, with filters retrieved
daily or more frequently and brought to a nearby Laboratory Response
Network (LRN) laboratory for genetic (PCR) analysis. Results are
available within 12 hours of filter retrieval. This system has been
operating continuously--24 hours a day, 7days a week, 52 weeks a year--
for more than three years and has performed greater than 2.5 million
assays without a false positive. There have been a very small number of
`true positives' in which BioWatch has detected extremely low amounts
of naturally occurring organisms when they are `stirred up' by unusual
environmental conditions. These `environmental positives' have helped
us to refine our concepts of operations and attest to the ultra-
sensitive detection levels of the system.
Gen 2: In FY05, we began a major enhancement to BioWatch, which we
call Gen 2 BioWatch. Gen 2 uses similar technology to Gen 1 but
provides a three-to-fourfold increase in the number of collectors in
the top ten or so threat cities thereby decreasing the minimum size
attack that can be detected and increasing the probability of
detection. The additional collectors are placed at locations of the
cities choosing, including critical transportation hubs such as subways
and airports. Each city also is given approximately 10 spare collectors
that they can deploy at special events of their choosing (e.g.
conventions, New Year's Day celebrations, ``Bowl Games''). Equally
important, the LRN laboratory analysis capabilities have been improved
and expanded to enable analysis of not just the added number of
collectors but also of the anticipated number of environmental samples
that would be needed to `follow-up' on any positive. Gen 2 enhancements
will be completed by the end of FY06.
Gen 3: Because Gen 1 and Gen 2 systems involve the manual
collection of filters and analysis by laboratory staff, labor costs
account for about 75% of the operational costs associated with these
systems. This has limited both the number of collectors deployed and
the frequency with which filters are retrieved. To overcome these
limitations next generation detection platforms are currently under
development which will automatically perform the detection analysis at
the air sampling sites and wirelessly transmit any positives to the LRN
laboratory for human confirmation of the signal interpretation. These
systems will analyze the collected air samples four to six times daily
and test for approximately 20 agents bacterial, viral and toxin.
Laboratory tests will be completed in FY 2006 and field tests in FY
2007. The system will then be piloted in an existing BioWatch city (FY
2008) before initiating full scale deployment in FY 2009.
The autonomous nature of this Gen 3 system and its low operational
cost should allow us to greatly expand the coverage provided by
BioWatch. Compared with the Gen 1 and 2 systems, when fully deployed
the Gen 3 system will monitor more than twice as many people against a
ten times smaller attack over a much broader range of agents several
times per day and at an operational cost comparable to the current
system. In addition, because the Gen 3 technology is fully autonomous
and does not require proximity to an LRN it can be used anywhere in the
Nation--including smaller cities, towns, critical facilities and
infrastructure.
BIOWATCH CONCEPTS OF OPERATIONS AND SIGNAL INTERPRETATION
A positive BioWatch signal by itself does not mean that a
biological attack has taken place nor that there is a public health
risk? it means that the genetic material of that organism has been
detected. What follows next is a sequence of events to determine the
public health and national security implications of such a BioWatch
positive. This sequence includes confirmation of the signal,
notification of all concerned parties, initial and continuing
assessment of its public health and national security implications, and
characterization and reconstruction of the event to guide any needed
response. Agreed upon interagency guidelines for these concepts of
operations (CONOPS) are provided in the BioWatch Preparedness and
Response Guidelines developed jointly by DHS, CDC, EPA, and DOJ and
have been provided to each of the BioWatch localities to guide them in
developing written CONOPS reflecting their specific circumstances and
needs. Some of the key features of include:
The local public health department must decide within two
hours of a possible BioWatch positive whether it is truly a `verified
PCR positive' or whether there may have been some issues with the
equipment, reagents, or protocols.
If it is a verified PCR positive, then the appropriate local
authority must immediately notify the CDC Director's Emergency
Operations Center (DEOC), the DHS Homeland Security Operation Center
(HSOC) and the local FBI Weapons of Mass Destruction (WMD) coordinator.
The local BioWatch Advisory Committee (BAC) must have a
telecon with State, Local, and Federal stakeholders within two hours of
declaration of a verified PCR positive to make an initial assessment of
the significance of the event--factoring in the detection data, unusual
meteorological or environmental conditions, available health and
medical surveillance data, and any intelligence on possible activities
of concern in the area.
When deemed appropriate, conduct environmental sampling in the
near vicinity of the positive collectors to provide additional
information and hopefully recover a viable (living) organism for
subsequent culturing and testing.
Biological Warning and Incident Characterization (BWIC): in
determining the public health and/or national security significance of
the verified BioWatch PCR positive(s), the local decision maker must
assemble, integrate and interpret a large amount of information: e.g.
which collectors gave positive signals and which negative; where were
they located; what does plume modeling tell us about possible release
locations and possible additional sampling sites; are we seeing an
increased number of emergency room visits, school absences, or over the
counter drug sales in the potential exposure area? In the small number
of environmental positives we have had to date, this information has
been largely assembled `by hand' and shared through e-mail in various
incompatible, non-mergeable formats and scales.
To address this shortcoming, we have developed and are now piloting
the Biological Warning and Incident Characterization (BWIC) system, an
information technology framework and set of tools to assist the local
decision maker in assembling, integrating, and analyzing the
information needed to assess the public health significance of a
BioWatch positive. BWIC is designed to be compatible with and
integrated with the other emergency management tools used by the
locality and not require a stand alone system. It includes a
geographical information system (GIS) for registering all information,
tailored data bases to reflect the location of BioWatch and USPS
collectors and of key local assets and infrastructure; plume modeling
tools for assimilating BioWatch collector status and the results of any
additional environmental sampling; integration of local and regional
meteorological data to improve plume predictions and event
reconstruction; disease progression models to project the possible rate
of people presenting ill; and linkage to local medical surveillance
tools and/or CDC's BioSense data. In use, BWIC will provide the local
decision maker with an evolving understanding of the situation and help
guide the next steps. For example, the BioWatch readings (both positive
and negative) will be used to make initial estimates of possible
release locations and possible areas of exposure. This information will
then be used to guide local environmental sampling and to estimate the
number of potentially exposed people and when they would present ill.
Folding in the results of the environmental sampling and of comparing
projected vs. actual presentation of illnesses will then result in
improved estimates of possible source locations and exposed populations
and so on. When implemented, BWIC will allow password protected, role-
based access to appropriate local and state personnel and will also
export information to the Homeland Security Operations Center (HSOC)
and our Federal partners. The first generation BWIC system has been
developed and is currently being piloted in Chicago and Miami and is
scheduled to begin phased deployment to other BioWatch locales in FY07.
COORDINATION OF INTERAGENCY BIOMONITORING & BIODETECTION
Since the initiation of BioWatch, the United States Postal System
(USPS) has initiated the Biohazard Detection System for the monitoring
of mail distribution centers and the Department of Defense (DoD) has
initiated its Guardian Installation Protection Program for monitoring
of military bases. In addition, multiple agencies are involved in the
testing of `white powders' from various sources. Recognizing the needed
for a more coordinated and integrated approach to such biomonitoring,
the S&T Directorate has initiated several programs to improve
interagency coordination in this area.
BioNet: BioNet is a recently completed DHS funded, DoD executed
program to pilot integrated civilian and military concept of operations
for the early detection and characterization of biological events. The
pilot took place over a period of 14 months in San Diego, CA. and
produced:
Coordinated CONOPS that can be adapted for use by
other civil and military communities.
Recommendations for enhancing the current national
BioWatch guidelines.
An integrated capability for sharing data and
information between military and civilian personnel.
A framework for operational evaluation of
biomonitoring equipment.
Mobile high throughput laboratory capabilities to
reduce the processing time needed to support consequence
management decision-making.
Systems modeling and analysis tools to support
training, exercises, and studies.
The BioNet program demonstrated that active coordination of local
civilian and military organizations can increase situational awareness
of potential biological incidents and can improve decision-making to
shorten response time.
Biomonitoring MOU: An interagency Memorandum of Understanding (MOU)
on Coordinated Monitoring of Biological Threat Agents has been signed
by DHS, HHS, DoD, DoJ/FBI and USPS and is currently being implemented:
An initial draft of a coordinated National
Biomonitoring Architecture has been written and is being
iterated and refined by the signatories;
All signatories have committed to prompt notification
within two hours of a confirmed PCR positive;
A process for establishing the equivalency of the
different biodetection assays used by the participating
agencies has been agreed to and the thousands of samples to be
tested have been produced--with testing to commence shortly and
concluded later this year.
The DHS Office of the National Capitol Region has
instituted periodic meetings of all the Federal, State and
local partners in biodetection in the NCR as a first step in
making this coordinated system a reality in the NCR.
This MOU addresses the issues relevant to biological agent
detection and characterization necessary to make public health or
national security decisions. It does not address subsequent responses
which would be addressed by other arrangements and mechanisms.
Public Health Actionable Assays: The Biomonitoring MOU applies not
only to bioaerosol monitoring but to all biodetection for homeland
security purposed conducted by or on behalf of the signatory agencies.
This includes the monitoring of individual mailrooms and of suspicious
materials. This presents an even greater challenge since frequently
this monitoring is done by commercial services or systems using assays
of uncharacterized reliability, with the attendant possibility of false
alarms and non-optimal use of resources. The Biomonitoring MOU requires
that in the future all such biodetection only be done using assays that
have been deemed equivalent in performance by the testing procedures
set up in support of the MOU. To better meet this need, DHS in
coordination with CDC and DoD, have formulated an approach for working
with the private sector to make very high quality, extremely low false
alarm rate assays available to them for use in commercial detection
technologies. In this approach, the U.S. Government would provide
industry with the appropriate signatures to be tested on their
detection platforms using their protocols but tested by a U.S.
designated independent laboratory. If the combination of signatures,
protocols, and platform meet the equivalency requirements established
under the MOU then the combination (called an assay) would be
designated a ``USG--Public Health Actionable Assay'' meaning that any
positive results would not have to be retested in a government
laboratory prior to alerting the Public Health Community. Planning for
piloting this approach is now underway. This approach will be piloted
later this year.
DEVELOPMENT OF ADVANCED BIODETECTION TECHNOLOGIES
Still more capable biosurveillance systems will be enabled by
currently on-going research and development into new detection devices
and the associated assays for high confidence detection of biological
threat agents. To this end, DHS is developing next generation platforms
for both outdoor and indoor bioaerosol monitoring, for monitoring the
food supply, and for rapid characterization of foreign animal disease.
Each of these is described briefly below.
Biological Autonomous Networked Detectors (BAND): These are the
detection systems for the Gen 3 BioWatch System described above. They
must: operate fully autonomously in both outdoor and indoor
environments, requiring only monthly servicing; have relatively modest
acquisition and operating costs; be capable of simultaneously detecting
and identifying about 20 different species of bacteria, viruses and
toxins with ultra-high sensitivity (about 100 organisms in 18,000
liters of air) and with false alarm rates of one in ten million or
less. We are on track for having field prototypes of this system in
FY07 and piloting it side-by-side with BioWatch collectors in FY08.
Rapid Aerosol Detection Systems: These systems seek to detect an
aerosolized release of a biological threat agent in five minutes or
less, rather than the hours time frame of BAND. They will be used for
protecting critical facilities and special events, in a manner similar
to a smoke alarm--providing early warning so as to enable protective
measures that minimize exposure--e.g. turning off the air circulation
systems or evacuating personnel. Because they are designed to operate
in confined spaces, their sensitivity requirements are less demanding
than those of BAND but because they must ``report'' every 1-5 minutes,
their false alarm rates are more demanding. Field prototypes should be
available by the end of FY08.
Food Biological Agent Detect System (FBADS): In coordination with
the HHS' Food and Drug Administration (FDA), we are developing a `food
sensor' to detect the presence of biological threat agents in various
food matrices at the central processing plants prior to the product
entering the food distribution stream. The requirements for these
sensors reflect both the challenge of detecting biological agents in
various complex food matrices as well as the operational considerations
of involved food sectors. A production prototype of FBADS is scheduled
to be delivered for testing by the end of FY07.
High Throughput Agricultural Diagnostics: The laboratory surge
capacity to rapidly diagnose and characterize the outbreak of a foreign
animal disease such as Foot and Mouth Disease is key element of this
Nation's strategy for containing any such outbreaks. Therefore, in
collaboration with partners in the USDA's National Animal Health
Laboratory Network (NAHLN), we are developing a high throughput
diagnostic platform that will provide a ten to hundred fold increase in
the number of samples that can be analyzed in a day, that can be
combined as modular units to provide even greater throughput should
that be needed, and that can fit it to a van for mobile deployment to
an outbreak site should that be desired. This technology is being
demonstrated later this fiscal year and being transferred to the NAHLN
in 2007.
Biodetection Assays: the detection platforms described above are
only as useful as the bioassays that they contain. The requirements on
these assays are indeed daunting. They must: cover the broad range of
bacteria, viruses, and toxins of concern; they must detect all strains
of the agents of interest and reject all `look alikes' and
environmental contaminants with false alarm rates of one in a ten
million or better; they must be capable of working in combination--
simultaneously detecting multiple agents to reduce detection times and
costs; they should be robust against bio-engineering; and they must
only costs cents per assay so as to be affordable for continuous
monitoring operations. By end of FY07 we will have such assays
available and in validation testing by the CDC for the top 20 agents to
be detected by Gen 3 BioWatch. By FY09 all these assays will be tied to
`virulence factors'--genetic features that are essential to a
biological agent to cause illness--thereby making these assays
extremely hard for the terrorist to use genetic engineering to defeat.
CONCLUSION
In summary, the Department of Homeland Security's Science and
Technology plays a major role in biosurveillance as called out both in
the President's Biodefense for the 21st Century and in the President's
Integrated Biosurveillance Initiative as subsequently funded by
Congress. We have provided the Nation with its first operational
bioaerosol monitoring capability. We continue to improve that system,
introducing new technologies to significantly increase its capabilities
and to lower its costs thereby allowing us to extend coverage to
greater parts of the Nation. And we are working with our partnering
agencies to develop a nationally coordinated Biomonitoring system and
to develop food contamination and agricultural outbreak detection
systems to greatly improve surveillance capabilities in those sectors.
All these biodetection capabilities are designed to feed into the
National Biosurveillance Integration System (NBIS), being led by the
DHS Preparedness Directorate, thereby providing the Nation with the
biological situational awareness needed to better detect and respond to
any biological attacks on this Nation's people, agriculture or
infrastructure.
This concludes my prepared statement. With the Committee's
permission, I request my formal statement be submitted for the record.
Mr. Chairman, Ranking Member Langevin, and Members of the Committee, I
thank you for the opportunity to appear before you.
Mr. Linder. Thank you, Dr. Vitko.
Dr. Besser?
STATEMENT OF DR. RICH BESSER, DIRECTOR, COORDINATING OFFICE OF
TERRORISM PREPAREDNESS AND EMERGENCY RESPONSE, CENTERS FOR
DISEASE CONTROL AND PREVENTION
Dr. Besser. Good afternoon, Chairman Linder, Ranking Member
Langevin and members of the subcommittee. Thank you for the
opportunity to be here. I am Richard Besser, director of the
Centers for Disease Control and Prevention's Coordinating
Office for Terrorism Preparedness and Emergency Response.
I am pleased to provide this testimony to update you on
CDC's efforts to enhance biosurveillance, to continue
implementation of the BioSense program, and the plans under way
to enhance collaboration with the national biosurveillance
integration system at the Department of Homeland Security. I
will summarize my remarks and respectfully request that my
complete written testimony be included for the record.
The health and security of the United States depends on our
preparedness against terrorism, including bioterrorism, as well
as natural public health emergencies. These threats necessitate
that we improve our public health and medical systems so that
we can respond with greater flexibility, speed and capacity to
handle mass casualties and large-scale emergency response in
coordination with our traditional emergency response partners,
as well as those at the Department of Homeland Security and
Department of Defense.
The Department of Health and Human Services is responsible
for leading federal public health efforts to ensure an
integrated and focused national effort to anticipate and
respond to emerging threats from biological and other weapons.
Within HHS, CDC supports these activities through a set of
strategic preparedness goals and extensive coordination and
collaboration with a number of federal departments and
agencies.
In collaboration with many crucial partners and
stakeholders, CDC has built an infrastructure to catalyze and
implement biodefense activities. To support this
infrastructure, CDC has established nine agency preparedness
goals to strategically direct resources. Taken together, these
goals provide a strategic framework from which to establish and
implement preparedness programs, and our biosurveillance
efforts support this framework.
CDC has made considerable advancements in biosurveillance
through the BioSense program. I will focus my remaining time on
three specific topics: the description of the BioSense program;
evaluation activities and the goals of BioSense; and lastly,
current collaboration with the Department of Homeland Security
to integrate BioSense data into the national biosurveillance
initiative.
BioSense is a national program intended to improve the
nation's capabilities for conducting near-real-time
biosurveillance in health situational awareness through access
to existing data from healthcare organizations across the
country. BioSense receives, analyzes and evaluates health data
from numerous data sources such as emergency rooms, ambulatory
care clinics, pharmacies, poison control centers, and clinical
laboratories.
The visible component of BioSense is a Web-based
application which enables healthcare facilities and state and
local public health organizations to see data from their own
communities. In 2002, BioSense was developed and began
receiving data from the Department of Veterans Affairs and the
Department of Defense ambulatory care clinics, as well as
laboratory test orders from LabCorp, largest commercial
laboratory in the United States. These data are currently not
transmitted in real-time.
In 2005, CDC received additional funding that enabled
BioSense to expand and begin receiving real-time clinical data
from public and private hospitals and healthcare facilities.
BioSense now receives real-time data from over 30 healthcare
facilities in 10 major metropolitan areas in the U.S. In 2006,
CDC's goal is to increase these numbers and begin receiving
real-time data from up to 40 metropolitan areas, including a
total of up to 350 health care facilities.
In addition to adding private and public real-time data
sources, CDC is also working with the VA, DOD and LabCorp to
begin receiving their data in real-time. And this year,
BioSense will begin incorporating data from the American
Association of Poison Control Centers. CDC expects the longer-
term goals of BioSense to be informed by evaluations and
feedback from the users of the application.
CDC recognizes the need to perform evaluations of BioSense
as it is developing in order to enhance its capabilities and
usefulness. BioSense recently underwent a formal review through
HHS's ongoing program to review major IT investments, and the
findings were favorable. There are also several evaluation
efforts beginning this year. CDC plans to award a cooperative
agreement to scientifically evaluate a number of aspects of the
BioSense system, including usability, validity of data, and
usefulness of data types.
In addition, CDC is working with a major independent IT
consulting firm to complete an assessment of BioSense systems
and ensure the chosen architecture and implementation approach
is in alignment with industry best practices. This assessment
started in May 2006 and will be completed over the next 6
months. The intent of the study is to do a thorough review of
all aspects of the system, including the architecture platform
and operations.
CDC is also seeking input and feedback on BioSense from
state and local public health and hospital users in the form of
a users meeting scheduled later this month, and a focused
discussion with nationally recognized experts in informatics
and biosurveillance in June. All of these activities will allow
CDC to examine the BioSense system in order to enhance its
capabilities.
To conclude my oral testimony, I would like to provide an
update on the status of our information-sharing discussions
with the Department of Homeland Security on the national
biosurveillance initiative. The national biosurveillance
initiative, launched in 2005, directed federal agencies to
enhance biosurveillance capabilities to reduce the detection
time following an attack, confirm the size and characteristics
of the attack, and initiate a response.
The initiative established NBIS at Homeland Security to
combine and analyze the information collected from various
sources. CDC has engaged in initial discussions with DHS staff
to determine how BioSense data will be most useful in data
integration efforts of the NBIS system. Specific data-sharing
activities will be determined over the coming months as
information available through BioSense and other
biosurveillance systems are evaluated for validity and
usefulness, and through further discussions with DHS personnel.
CDC is exploring options for providing staffing and
technical assistance to NBIS, for interpretation of BioSense
data, and how that data complements the other NBIS components.
CDC is committed to working with DHS and welcomes further
guidance in discussions to advance the sharing of critical
public health information to enhance homeland security efforts.
Mr. Chairman, that concludes my remarks. Thank you for the
opportunity to share this information. I will be happy to
answer any questions.
[The statement of Dr. Besser follows:]
Prepared Statement of Dr. Richard E. Besser
Introduction
Good afternoon, Mr. Chairman and Members of the Subcommittee. I am
grateful for the opportunity to be here today to provide testimony on
CDC's terrorism and emergency preparedness efforts, our efforts to
enhance biosurveillance through continued implementation of the
BioSense program, and the plans underway to enhance collaboration with
the National BioSurveillance Integration Center at DHS. I am Richard
Besser, Director of the Centers for Disease Control and Prevention's
Coordinating Office for Terrorism Preparedness and Emergency Response.
In this role, I have primary oversight and responsibility for all
programs that comprise CDC's terrorism preparedness portfolio.
Overview of CDC's Preparedness Efforts
The health and security of the United States depends on our
preparedness against terrorism, including bioterrorism, as well as
other public health emergencies including the threat of pandemic
influenza. These threats necessitate that we improve our public health
and medical systems so that we can respond with greater flexibility,
speed, and capacity to handle mass casualties and large-scale emergency
response in coordination with our traditional emergency response
partners as well as those at the Department of Homeland Security (DHS)
and Department of Defense (DoD).
HHS is responsible for leading Federal public health efforts to
ensure an integrated and focused national effort to anticipate and
respond to emerging threats from biological and other weapons. HHS is
also the principal Federal agency responsible for coordinating all
Federal-level assets activated to support and augment the state and
local medical and public health response to mass casualty events.
Within HHS, CDC supports these activities through extensive
coordination and collaboration with a number of federal departments and
agencies. I will focus my remarks on CDC's role and accomplishments in
terrorism preparedness and emergency response, with emphasis on the
BioSense program.
CDC'S Strategic Preparedness Framework
CDC has made terrorism preparedness and emergency response a
priority and has built an infrastructure to catalyze and implement
biodefense activities and collaborate with our Federal, state, and
local government partners as well as with the private sector, non-
governmental organizations, and tribal nations. To do this effectively,
CDC has established nine agency preparedness goals to strategically
focus and efficiently direct CDC resources. These goals are aligned
under three overarching categories: Pre-Event, Event, and Post-event.
Taken together, these goals provide a strategic framework from which to
establish and implement preparedness programs, with the goal of
integrating our activities with those of our emergency response
partners at all levels of government and the private sector. I would
like to share with you some of the key activities CDC has undertaken
and our progress toward achieving these goals, particularly in the
arena of biosurveillance.
BioSurveillance for Enhanced Situational Awareness
Traditionally, public health surveillance systems were designed to
identify trends in health indicators and identify diseases for
reporting purposes. Historically, these were manual systems that
evolved to computerized systems, but which remained fragmented and slow
in exchanging information between clinical care providers and public
health. CDC, through its new National Center for Public Health
Informatics (NCPHI), has been pursuing fundamental changes in the way
public health surveillance is conducted in the United States. NCPHI's
efforts have been focused on upgrading information technology,
standardizing data across multiple settings, and establishing systems
for electronic data exchange. These changes are important to all of our
public health efforts--but are particularly critical to our efforts in
terrorism preparedness and response. In the event of a bioterrorism
attack or widespread outbreak, traditional systems may fail to identify
ill persons quickly enough for the delivery of appropriate
countermeasures, increasing the likelihood of further transmission of
disease or death. To achieve this level of information timeliness,
biosurveillance systems must be electronic and enable transmission of
existing health information to public health decision-makers in real-
time. Such systems will not only assist public health to detect disease
early and identify persons affected, but will also help to confirm or
refute the presence of illness in a given community, characterize the
progression of an outbreak once it's identified, and assess the
effectiveness of control measures.
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, required specific activities to improve the
nation's preparedness for bioterrorism and other public health
emergencies by increasing coordination and planning among federal,
state, and local public health and healthcare providers. The Secretary
of HHS was required to provide for the establishment of an integrated
system or systems of public health alert communication and surveillance
networks among (1) federal, state, and local public health officials;
(2) public and private health-related laboratories, hospitals and other
health care facilities; and (3) other entities that the Secretary
determined appropriate. Coordination of these surveillance networks is
intended to provide channels for secure and timely sharing and
discussion of essential information concerning bioterrorism and other
public health emergencies as well as recommended methods for responding
to such an attack or emergency.
The 2002 Act clearly highlighted the need for improving public
health's capabilities for electronic health surveillance. HHS outlined
two strategies aimed at achieving this goal: (1) unifying public health
surveillance architectures to allow for the exchange of information
among health care organizations, organizations with which they
contract, and state and federal agencies and (2) streamlining quality
and health status monitoring to allow for a more complete look at
quality and other issues in real-time and at the point of care.
BioSense is the response to the Public Health Information
Technology Initiative set forth by HHS. BioSense is a national program
intended to improve the nation's capabilities for conducting near real-
time biosurveillance and health situational awareness through access to
existing data from healthcare organizations across the country. The
visible component of BioSense is the web-based application which
enables healthcare facilities and state and local public health
organizations to see data from their own communities.
Overview and Objectives of the BioSense Program
Currently, the majority of health-related information systems that
exist nationally vary in their ability to share data to support
immediate biosurveillance needs. Many local public health agencies lack
the resources, the desire, and/or the needed expertise to develop and
support a local comprehensive biosurveillance system. Therefore, CDC is
developing a single national system that allows local use of local
health data. There is no other system that conducts real-time
electronic biosurveillance on a national scale. BioSense will connect
existing health information to public health in a way not previously
possible, by providing public health access to data from hospitals,
healthcare systems, and other sources. BioSense is developing and
implementing enhanced capabilities to rapidly detect and monitor
bioterrorism, natural disease outbreaks, and other events of public
health importance. In addition to early event detection, BioSense will
support on-going investigations and responses of suspected bioterrorism
or outbreak events by providing real-time health situational awareness.
The primary objective is to expedite event recognition and response
coordination among federal, state, and local public health and
healthcare organizations by providing each level of public health
access to the same data, at the same time.
Specifically, BioSense focuses on:
Data transmission--to assure the secure, timely,
routine receipt of health data for public health surveillance;
Data analysis--utilize advanced analytic methods to
detect events and to enable cities and states to use these
methods to interpret results in as close to real-time as
possible;
Data reporting--on a near real-time basis, provide
useful views of the data, including time series analysis and
geospatial displays, for colleagues in state and local health
departments, as well as for CDC program staff;
Public Health Response--to provide local data to state
and local public health officials, and support their use and
interpretation of these data for investigations, outbreak
response and public health interventions.
Community preparedness is at the foundation of BioSense. State and
local public health authorities are one of the real ``end users'' of
BioSense, because they are the first responders to health events. State
and local public health authority to investigate and mange outbreaks
will not be superseded by CDC. Traditional protocols for public health
investigations at the local level will continue be the standard and CDC
will only assist public health departments when invited. In alignment
with CDC's community health protection goal ``People prepared for
emerging health threats,'' BioSense contributes to community
preparedness by enabling public health activities related to achieving
four specific preparedness goals:
CDC Preparedness Goal #2--Decrease the time needed to classify health
events as terrorism or naturally occurring, in partnership with other
agencies.
BioSense will provide, on a near real-time basis,
standardized health data with broad geographical coverage to
local, state, and federal public health jurisdictions.
Currently, public health must rely on an amalgam of electronic
and manual processes in a waterfall model of reporting
(hospital to local to state to CDC) making the event
identification process fraught with underreporting and delay.
Providing this ``window on the status of community
health'' will reduce the amount of time it currently takes to
access data needed to classify naturally occurring outbreaks
and potential bioterrorism events.
BioSense will also employ natural language processing
and statistical and science-based algorithms that help
recognize potential outbreaks and provide access to supporting
clinical data about the cause of the outbreak.
CDC Preparedness Goal # 4--Improve the timeliness and accuracy of
communications regarding threats to the public's health.
BioSense allows for simultaneous access of the same
data by all levels of public health and the healthcare systems
that are contributing data. If any one level identifies a
suspected event, others (including the healthcare organization
itself) can be invited into a coordinated conversation based on
current, detailed healthcare data. This allows better
communication regarding necessary action, further
investigation, or mobilization of resources.
BioSense provides cross-jurisdictional views that can
help identify events that may be occurring simultaneously in
multiple and/or neighboring jurisdictions. This is not possible
with local surveillance systems limited by political,
geographical, and jurisdictional boundaries.
CDC Preparedness Goal # 5--Decrease the time to identify causes, risk
factors, and appropriate interventions for those affected by threats to
the public's health.
BioSense will employ technological and data standards
to connect public health to a breadth of real-time healthcare
data not currently available to state and local health agencies
and CDC. The focus will be on accessing existing health data
from emergency departments, hospitals, clinics, and other
related data sources in the major U.S. metropolitan areas.
Timely access to the breadth of health data described below
will give public health the tools to identify probable disease
causes more quickly and make more informed intervention
choices.
BioSense includes the following data types:
Foundational (demographics, chief complaint,
presumptive or working diagnosis, disposition, hospital
utilization)
Clinical (vital signs, triage notes, discharge
summary and diagnosis)
Laboratory (laboratory orders, microbiology
results)
Pharmacy (medication orders)
Radiology (Radiology orders, radiology
interpretation results)
Having access to a centralized and standardized data
set will also provide the ability to perform retrospective
analyses across multiple jurisdictions and data types.
Information from these analyses can then be applied to future
events to identify causes earlier and begin interventions more
quickly.
Preparedness Goal # 6--Decrease the time needed to provide
countermeasures and health guidance to those affected by threats to the
public's health.
Using BioSense, public health can understand the
number of patients presenting at healthcare organizations, what
their symptoms are, and what actions clinicians are taking to
diagnose and treat. This allows public health to determine what
information is needed by clinicians to guide care decisions,
and to properly inform the general public regarding actual
versus perceived health risks.
In addition, understanding of available
hospital resources, as available in BioSense, allows
effective and timely countermeasures and guidance to
early responders and officials.
Current Status and Goals of the BioSense Program
After the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 was enacted, BioSense was developed and began
receiving data from Veterans Affairs and the Department of Defense
ambulatory care clinics as well as laboratory test orders from
LabCorp--the largest commercial laboratory in the United States. In
2005, CDC received additional funding to expand BioSense to receive
real-time clinical data from public and private hospitals and
healthcare facilities. Beginning with hospitals in 10 large
metropolitan areas, CDC is developing a real-time clinical information
surveillance system that, when fully deployed, will be a rich and
timely data warehouse for early event detection and situational
awareness. It will require substantial funding, take several years to
develop and refine, and require input from the users and other
stakeholders, but the potential benefit of this program to public
health is tremendous. As national efforts focus on advancing the
clinical health information technology component--crucial for the care
of each individual patient--it is equally crucial that the overall
public health system surveillance component is built to allow for
efficient public health response based on accurate and timely
information.
BioSense receives, analyzes, and evaluates health data from
numerous data sources such as emergency rooms, ambulatory care clinics,
pharmacies, poison control centers, and clinical laboratories. In
addition to data from VA and DoD treatment facilities, and LabCorp,
BioSense also receives data from over 30 health care facilities in 10
major metropolitan areas in the U.S. In 2006, CDC's goal is to begin
receiving real-time data from up to 40 metropolitan areas, including a
total of up to 350 healthcare facilities. In April, 2006, CDC released
a new version of the BioSense application which includes health
situational awareness functionality and access to the new real-time
data streams.
Evaluation
CDC recognizes the need to perform evaluations of BioSense as it is
developing. BioSense recently underwent a formal review under HHS'
ongoing program to review major IT investments, and the findings were
favorable. CDC is working with the Gartner Group, a major independent
IT consulting firm, to complete an assessment of the BioSense system to
ensure the chosen architecture and implementation approach is in
alignment with industry best practices. This assessment is expected to
begin May, 2006 and be completed over a six month period. The intent of
the study is to do a thorough review of all aspects of the BioSense
technical architecture, platform and operations. The study will
identify strengths and weaknesses as well recommendations for
improvements.
CDC also plans to award a cooperative agreement to scientifically
evaluate a number of aspects of the BioSense system including
usability, validity of data, and usefulness of data types. In addition,
the National Center for Public Health Informatics at CDC will be
engaging Centers of Excellence in Public Health Informatics to provide
input and focus on the efforts of the Center, including BioSense. To
complement these activities, CDC has also funded four grantees to
develop the science of early event detection and situational awareness
through the secondary use of existing information in electronic,
health-related databases. The grants focus on three broad areas: (1)
increasing the sensitivity and specificity of detection algorithms, (2)
establishing the efficacy of different data sources, and (3) developing
software methods and components compatible with the Public Health
Information Preparedness Initiative functional and technical
specifications.
In addition, CDC is seeking input and feedback on BioSense from the
state/local public health and hospital users in the form of a Users
Meeting scheduled for May 23-24, 2006 in Atlanta. The goal of the
meeting is to gain vital input and open an ongoing communication
channel with the user community. In addition, approximately 25
nationally recognized experts in informatics and biosurveillance are
being invited to meet with CDC as a Science Group, planned for June 27,
2006. This group will focus on the science of the system including
appropriate algorithms, analysis and visualization techniques, and data
streams of interest.
Privacy
Privacy and confidentiality of health data is extremely important
to CDC, and in addition to the security measures in place, we have
taken several steps to ensure the protections of the data transmitted
through BioSense. Most importantly, obvious patient identifiers are
excluded from the data transmitted through BioSense. In addition, data
sharing agreements are signed with each hospital that define the
authorized CDC and public health uses and responsibilities regarding
the data. BioSense records are protected by the medical records privacy
regulation under the Health Insurance Portability and Accountability
Act, and CDC takes even further steps to apply other legislative
authorities to ensure these data are afforded maximum confidentiality
protections.
Electronic Data Sharing Standards and Information Sharing with the
Department of Homeland Security
The work conducted in the National Center for Public Health
Informatics, and in particular through BioSense will support the HHS
Office of the National Coordinator for Health Information Technology
(ONC) Health Information Technology Standards Panel (HITSP). HITSP is a
collaborative effort to harmonize health information interoperability
standards, particularly health vocabulary and messaging standards.
Through HHS' ONC, BioSense also supports the work of the American
Health Information Community (AHIC or ``the Community'') and
specifically the BioSurveillance Workgroup. The Community was formed to
help advance efforts to reach President Bush's call for most Americans
to have electronic health records within ten years. Chaired by the
Secretary of HHS, the Community provides input and recommendations to
HHS on how to make health records digital and interoperable, and assure
the privacy and security of those records. The standards set forth by
the HITSP collaboration will be presented to the Community for
endorsement. BioSense data standards directly support the work needed
to make the AHIC recommendations a reality.
In addition to the support of HHS and AHIC standards, The National
Biosurveillance Initiative, launched in 2005, directed Federal agencies
to enhance biosurveillance capabilities to reduce the detection time
following an attack, confirm the size and characteristics of the
attack, and initiate a response. The initiative establishes a National
Biosurveillance Integration System (NBIS) at the Department of Homeland
Security (DHS) to combine and analyze information collected from human,
animal and plant health, food and environmental monitoring systems.
Such an analysis, combined with evolving threat and intelligence
information, will provide greater context for those making critical
homeland defense decisions. This is a broader system which BioSense
summary data will complement.
CDC has engaged in initial discussions with DHS staff to determine
those data that would be most useful for sharing as part of the NBIS
data integration efforts. Specific data types will be determined over
the coming months as the information available through BioSense and
other biosurveillance systems are evaluated for their validity and
usefulness. CDC welcomes further guidance and ongoing discussions with
DHS to advance the sharing of critical public health information to
enhance homeland security efforts.
Thank you for the opportunity to share this information with you. I
am happy to answer any questions.
Mr. Linder. Thank you, Dr. Besser.
Ms. Embrey?
STATEMENT OF ELLEN EMBREY, DEPUTY ASSISTANT SECRETARY OF
DEFENSE FOR FORCE HEALTH PROTECTION AND READINESS
Ms. Embrey. Good afternoon. Thank you very much for
inviting me here to join you and the members of the
subcommittee today.
I am here to discuss the work that DOD is doing in
biosurveillance and to describe how we are working to integrate
our existing biosurveillance systems with those of other
federal agencies in support of the Department of Homeland
Security's national biosurveillance integration system.
Emerging and re-emerging infections such as SARS and the
H5N1 strain of avian influenza, along with the continuing
threat of bioterrorism, highlights the need for an innovative,
integrated national disease surveillance system such as the
national biosurveillance integration system.
The Department of Defense has joined efforts with the
Department of Homeland Security, CDC, and other government
agencies to best utilize existing surveillance capabilities to
obtain the most accurate, comprehensive picture of American
public health. DOD's electronic surveillance system for the
early notification of community-based epidemics, also referred
to as ESSENCE, is a critical Defense Department biosurveillance
system that supports NBIS.
ESSENCE is an early warning system for biological events,
whether natural or caused by the accidental or intentional
release of biological agents. DOD shares their ESSENCE
outpatient data stream with the CDC for analysis, using their
BioSense system, which in turn will eventually provide reports
to the NBIS for integration into an overall national picture.
Through an integrated approach to surveillance, CDC and DOD
analysts can definitively interpret health data, enhance
situational awareness, and improve response capacity. In order
to capitalize on current integrated NBIS surveillance
capabilities, the Department of Defense is working with the
Department of Homeland Security to establish shared reporting
and improved communication in support of NBIS. To help reach
this goal, the Department of Defense has already placed a
military liaison in the NBIS DC office, and we plan to position
additional liaisons in various combatant command headquarters.
DOD's ESSENCE is among the nation's largest health
surveillance systems, with a considerable domestic and
international footprint. ESSENCE gathers health data from more
than 440 military clinics and hospitals around the globe. This
extensive data-set provides us with significant information on
symptoms and syndromes, and allows us to detect outbreaks of
infectious disease much sooner than ever before.
Such early detection of infectious disease outbreaks allows
us to gain precious time in protecting individuals with
immunizations and medical treatment, also to help us better
allocate health services and equipment, as well as to enable
early as possible use of non-pharmacological and risk
communications strategies to limit the spread of disease.
These benefits apply to the community immediately affected,
as well as to the region that may eventually be impacted by a
disease outbreak or biological event. ESSENCE was originally
developed to enhance our ability to detect as early as
possible, and improve our situational awareness for potential
bioterrorist attacks in the Washington, DC area.
Through the years, it has evolved to provide important
biosurveillance information on human disease. When fully
integrated into the networked biosurveillance community, the
information gathered through ESSENCE and the military treatment
facilities around the globe can help support overall efforts to
provide key decision-makers with information that will provide
early recognition of biological outbreaks with potential
national significance, and thus improve decision-making and
facilitate timely response.
In closing, I want to reinforce DOD's commitment to
ensuring that the NBIS objectives are met, and I thank you for
your leadership in supporting biosurveillance, nationally and
in the Department of Defense.
I stand ready to answer any questions that you may have
about our systems.
[The statement of Ms. Embrey follows:]
Prepared Statement of Ellen P. Embrey
Good morning and thank you for inviting me to join you today.
I am here to discuss the work DoD is doing in biosurveillance and
to describe how we are integrating our existing systems with those of
other government agencies in support of the National Biosurveillance
Integration System.
Over the past few years, our citizens have faced exposure to many
human and animal biological threats, underscoring the need to enhance
our plans to respond to biological events of national significance. The
appearance of emerging and reemerging infections, such as SARS and the
H5N1 strain of avian influenza, along with the ongoing threat of bio-
terrorism, has highlighted the need for an innovative, integrated
national disease surveillance system, such as the one proposed through
the National Biosurveillance Integration System (NBIS).
In the U.S. military, we face this challenge with every operation
and every deployment. The early recognition of these events using
public health surveillance techniques has long been an integral part of
our day-to-day work and enhances our ability to respond quickly to
protect our service members' health and maximize operational readiness.
Some of the many ways we work to safeguard the health of our
service members both at home and in theater include testing air, soil
and water in areas where we deploy our troops, assessing their
individual health, and monitoring any relevant medical surveillance
data The systems that we have sponsored and cultivated can play an
important role in a national networked biosurveillance community.
In addition to monitoring the health of service members, DoD has
joined efforts with NBIS, Centers for Disease Control and Prevention
(CDC) and other government agencies to best utilize existing
surveillance capabilities to obtain the most accurate, comprehensive
picture of American public health.
ESSENCE, the Electronic Surveillance System for the Early
Notification of Community-Based Epidemics, is one of the Defense
Department's biosurveillance systems that supports NBIS--national
biosurveillance capabilities.
ESSENCE is an early warning system for biological events, including
natural disease outbreaks and disease caused by the accidental or
intentional release of biological agents. DoD shares their outpatient
data from ESSENCE with the CDC for analysis using their BioSense
system, which in turn provides reports to NBIS for integration into an
overall national pattern. Through an integrated approach to
surveillance, CDC and DoD analysts can definitively interpret health
data, enhance situational awareness and improve response capability.
In order to capitalize on current NBIS integrated surveillance
capabilities, DoD is working in coordination with NBIS' National
Biosurveillance Group to establish shared reporting and improved
communication. To help reach this goal, DoD has already placed a
military liaison in the NBIS District of Columbia office and plans to
position additional liaisons at various Combatant Command (COCOM)
headquarters.
ESSENCE enables us to identify increases in the frequency of
carefully defined categories of diseases occurring at military
treatment facilities around the world. This detection capability
provides the Military Healthcare System with the information needed to
facilitate informed decision-making and enable timely response,
including the allocation of any needed medical assistance, resources
and supplies to control disease outbreaks and render timely medical
care to those already affected.
The human and materiel resources of the Department of Defense are
the most forward deployed of any U.S. government resource, and ESSENCE
is no exception. ESSENCE is the nation's largest health surveillance
system, with a considerable domestic and international footprint.
ESSENCE gathers health data from 313 military medical treatment
facilities around the world. This extensive data set provides us with
significant information on symptoms and syndromes and allows us to
detect outbreaks of infectious disease much sooner than ever before.
The early detection of infectious disease outbreaks using ESSENCE
allows us to gain precious time in protecting individuals with
immunizations and medical treatment, helps us to appropriately allocate
health services and equipment, and affords us the opportunity to engage
in non-pharmacological and risk communications strategies to limit the
spread of disease. These benefits apply to the community immediately
affected as well as to the region at large that may eventually be
impacted by the disease outbreak or biological event.
For example, if an unusually high number of people in one area are
being seen with influenza-like symptoms and illnesses, that information
may indicate the beginnings of an influenza epidemic. By tracking the
syndrome of influenza-like illness in ESSENCE, we can lessen the time
it takes to determine that an outbreak is occurring. If abnormal
clusters of symptoms or disease are occurring, then ESSENCE will
trigger an alert to local officials, who can then investigate the
situation and determine whether a concerted and coordinated public
health response is required.
Since its inception in 1999, enhancements to ESSENCE's analytical
capability to detect potential disease outbreaks have been implemented.
New features include revised syndromic groups to address a broader
range of biological threats and standardized mappings of diagnostic
codes for each of the re-designed syndromic groups. Data filters
identify reportable medical events like anthrax and new data sources,
such as prescribed medications complement diagnostic data. One
significant enhancement is the ability to display spatial clusters
detected over geographic areas.
These improvements make ESSENCE more flexible in its ability to
detect disease outbreaks, more compatible with military and civilian
surveillance systems, and more capable of pinpointing outbreak
locations that in turn allow for tailored responses by DoD public
health professionals. Still, by itself it is just a software
application. The critical factor is the human analyst who must
interpret the automated alerts and sort out the false alarms from the
real outbreaks. The DoD uses a tiered approach. The linchpin is the
local military public health professional, who monitors ESSENCE with
respect to their local beneficiary population. This individual is in
the best position to investigate any unusual trends and immediately
determine whether there is a problem and to coordinate with the local
civilian public health authorities. However, patterns across a region
may also be important, so each of the Services have public health
centers where epidemiologists monitor ESSENCE and other health-related
data streams, interfacing with the installations and providing
consultative support and assisting with on-site investigations as
needed. Tying all of these separate public health networks together
falls to the Armed Forces Health Surveillance Center (AFHSC). The AFHSC
is a new organization that will combine several existing surveillance
groups together into a DoD center that will serve as the single
official source for all DoD health surveillance information. Key
components of the center will include the Army Medical Surveillance
Activity, the Global Emerging Infections Surveillance and Response
System (GEIS), and the surveillance resources in the Deployment Health
Support Directorate. The center is expected to reach initial operating
capability in FY08, but it already serves as the DoD liaison with DHS's
NBIS, CDC's BioSense programs and other syndromic surveillance research
groups, all working together to develop the most effective techniques
and methods for detecting symptoms of potential disease outbreaks, an
evolving discipline of public health.
ESSENCE was originally developed to enhance our ability to detect,
as early as possible, and to improve our situational awareness of
potential bio-terrorist attacks in the Washington, D.C. region. Through
the years, it has evolved to provide important biosurveillance
information on human disease. When fully integrated into the networked
biosurveillance community, the information gathered through ESSENCE and
the military treatment facilities across the globe can support the
overall effort to provide key decision makers with early recognition of
biological events of potential national significance, and thus,
facilitate national decision-making and enable timely response.
I thank you for your time today and your leadership in supporting
biosurveillance in the Department of Defense. We look forward to
continuing to play a role in the National Biosurveillance Integration
System and enhancing the national biosurveillance network. I appreciate
the opportunity to address you today, and would be happy to answer any
questions you have about ESSENCE or Defense Department surveillance
systems.
Mr. Linder. Thank you, Ms. Embrey.
Dr. Clifford?
STATEMENT OF DR. JOHN CLIFFORD, DEPUTY ADMINISTRATOR FOR
VETERINARY SERVICES, DEPARTMENT OF AGRICULTURE
Dr. Clifford. Chairman Linder, Ranking Member Langevin and
members of the subcommittee, thank you for holding this hearing
today and for the opportunity to testify before you.
Today, the committee is looking at an important issue, the
federal government's plan for the coordinated evaluation of all
biosurveillance information collected in the United States. We
at USDA are actively engaged in this effort, both internally
and with our colleagues from the U.S. Department of Homeland
Security.
I am very pleased to provide the following outline of our
animal health surveillance programs and how we plan to further
analyze this information and provide our findings to NBIS. USDA
has been working for decades to enhance and refine our ability
to collect information regarding the health of our nation's
livestock, as well as our food supply.
The information we collect through surveillance and
monitoring channels has long served as the basis for our
regulatory, policy and operational decisions regarding U.S.
animal health and food safety. Generally speaking, USDA's
safeguarding systems are comprised of components such as
overseas monitoring of disease events, import restrictions,
surveillance efforts here in the U.S., as well as the measures
we take to eradicate and control disease and the regulation of
slaughter practices to protect the food supply.
Understanding the potential pest and disease threats to
U.S. agriculture as they exist in other countries, we can take
the necessary steps to keep pests and diseases out of the
country, while also looking for any signs of them within our
borders. Should our surveillance detect one of these pests or
diseases, we would then mount an aggressive control and
eradication program, while also closing the pathway responsible
for the introduction.
USDA's animal health safeguarding systems have largely
stayed ahead of evolving risk and have been highly effective in
preventing the introduction of serious animal diseases such as
foot and mouth disease and highly pathogenic avian influenza
into the United States. For example, APHIS swiftly responded to
a detection of high path AI in a flock of 6,600 birds in Texas
in 2004. By quickly becoming aware of the situation and working
with industry and state officials, we prevented further spread
of the virus.
As you know, disease such as high-path AI can also have
some human health implications. So it is central that we remain
vigilant and ensure we have robust emergency response plans and
capabilities at the ready.
Emergency response campaigns actually begin with effective
awareness of international animal health situations. APHIS
main-
tains this awareness through several different avenues,
including participation in international animal health
organizations, or OIE, safeguarding officers overseas to
collect information on foreign pests and diseases, and
monitoring open source information for indications of serious
international health events. In total, this information allows
us to take proactive preventive measures in response to
specific threats before we are faced with potential
introductions within our borders.
The next component is rapid domestic detection of foreign
animal disease, soon after incursion, before the disease
spreads further into susceptible animal populations. By
maintaining robust animal disease surveillance programs in the
U.S., we are also making a significant investment in our
emergency preparedness and response capabilities. Recognizing
the critical nature of these programs, APHIS' fiscal year 2007
budget included approximately $156 million for animal health
monitoring surveillance activities.
Since September 11, 2001, USDA has also made great strides
to expand our mission to include security. The department has
been working closely with federal, state and local government
partners, as well as industry stakeholders to address these
concerns via a sector-wide strategy based on White House
guidance.
We are relying on guidance provided in homeland security
presidential directive 7, 9 and 10, as well as guidelines under
emergency support function 11 under the national response plan.
These are strengthening our preparedness for intentional acts
of terrorism against food and agriculture, and helping us
enhance current programs designed to prevent or control
unintentional introductions of agents, pests and diseases that
could harm our sector.
In October, 2004, when DHS convened the first interagency
national biosurveillance group meeting to begin evaluating
additional streams of data in the NBIS, it was clear that
information related to domestic agriculture and food safety
will be critical to the overall effectiveness of the system.
As a result of careful consideration, in February, 2005
USDA decided to develop a new in-house food and agriculture
biosurveillance integration system which we call FABIS, to
accomplish two goals: achieve the high level of integration of
APHIS' animal health surveillance data with information from
the Food Safety and Inspection Service's food safety and
testing programs and to support our homeland security
responsibilities; and two, to develop a system that also
provides the NBIS with concise, analyzed data that can be
evaluated as part of a complete assessment of U.S. biosecurity.
USDA is pleased to have a close working relationship with
DHS colleagues as we move forward to develop of NBIS. I am
happy to answer any questions you might have regarding my
testimony.
[The statement of Dr. Clifford follows:]
Prepared Statement of Dr. John Clifford
Chairman Linder, Ranking Member Langevin, and Members of the
Subcommittee, thank you for holding this hearing today and for the
opportunity to testify before you. My name is Dr. John Clifford and I
am the Deputy Administrator for Veterinary Services with the U.S.
Department of Agriculture's (USDA) Animal and Plant Health Inspection
Service (APHIS). In this position, I also serve as USDA's Chief
Veterinary Officer.
Today, the Committee is looking at an important issue--the Federal
government's plan for the coordinated evaluation of all biosurveillance
information collected in the United States. We at USDA are actively
engaged in this effort, both internally and with our colleagues from
the U.S. Department of Homeland Security (DHS). I am very pleased to
provide the following outline of our animal health surveillance
programs and how we plan to further analyze this information and
provide our findings to the National Biosurveillance Integration System
(NBIS).
Overview of USDA's Animal Health Surveillance and Safeguarding Programs
USDA has been working for decades to enhance and refine our ability
to collect information regarding the health of our Nation's livestock,
as well as the food supply. The information we collect through these
surveillance and monitoring channels, including our off-shore pest and
disease monitoring efforts; cooperative animal disease testing
programs; and the established networks of laboratories that support our
domestic animal disease testing programs, has long served as the basis
for our regulatory, policy, and operational decisions regarding U.S.
animal health and food safety. In addition, utilizing this information,
we routinely make adjustments to the strong system of overlapping
safeguards we have in place to guard against the entry of potentially
damaging agricultural pests and diseases that are exotic to the United
States.
Generally speaking, these safeguarding systems are comprised of
components such as overseas monitoring of disease events, import
restrictions, surveillance efforts here in the United States, the
measures we take to eradicate and control disease, and the regulation
of slaughter practices to protect the food supply. In a nutshell, by
understanding the potential pest and disease threats to U.S.
agriculture as they exist in other countries, we can take the necessary
steps to keep the pests and diseases out of the country, while also
looking for any signs of them within our borders. Should our
surveillance detect one of these pests or diseases, we would then mount
an aggressive control and eradication program, while also closing the
pathway responsible for the introduction.
We customize the safeguarding systems to meet the unique challenges
significant foreign agricultural pests or diseases present to our
domestic industries. Therefore, our safeguarding systems against viral
animal diseases, such as swine vesicular disease, take into account
different risks and corresponding import controls (live swine and swine
products are prohibited entry into the United States from countries
affected by the disease) than our safeguarding systems against exotic
pests, like some species of ticks, that can be mitigated by treating
the animals with a pesticide prior to their entry into the United
States. But in all cases, our safeguarding systems complement one
another in that they draw on our extensive animal health surveillance
systems and have one main objective: protecting the health and
marketability of U.S. agriculture and the domestic food supply.
USDA's animal health safeguarding systems have largely stayed ahead
of evolving risks and have been highly effective in preventing the
introduction of serious animal diseases, such as foot-and-mouth disease
and highly pathogenic avian influenza (HPAI), into the United States.
As you know, diseases such as HPAI can also have some human health
implications, so it is essential that we remain vigilant and ensure
that we have robust emergency response plans and capabilities at the
ready.
A recent case in point is our swift response to a detection of HPAI
in a flock of 6,600 birds in Texas in 2004. By quickly becoming aware
of the situation and working with industry and State officials to
depopulate the flock, carry out onsite cleaning and disinfection, and
look for signs of disease in surrounding operations, we prevented
further spread of the virus. We also prevented a costlier eradication
program by USDA and State officials, as well as protracted trade
restrictions on U.S. poultry and poultry products by our trading
partners.
I want to note here that emergency response campaigns actually
begin with effective awareness of the international animal health
situation. APHIS maintains this awareness through several different
avenues, including by participating in international animal health
organization, or OIE, meetings; placing safeguarding officers overseas
to collect information on foreign pests and diseases in their countries
of origin; and monitoring open source information for indications of
serious international animal health events. In total, this information
allows us to take proactive, preventive measures in response to
specific threats before we are faced with potential introductions
within our borders.
The next component is rapid domestic detection of a foreign animal
disease soon after incursion--before the disease spreads further in the
susceptible animal population, or populations. By maintaining robust
animal disease surveillance programs in the United States, we are also
making a significant investment in our emergency preparedness and
response capabilities. Recognizing the critical nature of these
programs, APHIS' fiscal year (FY) 2007 budget included approximately
$156 million for our animal health monitoring and surveillance (AHMS)
activities, an increase of $10 million, or seven percent above the (FY)
2006 enacted. Overall, this is an increase of $81 million (+109%) since
FY 2001.
USDA's Food and Agriculture Biosurveillance Integration System (FABIS)
Since September 11, 2001, USDA has also made great strides to expand
our mission to include security. The Department has been working
closely with its Federal, State, and local government partners, as well
as with industry stakeholders to address these concerns and others via
a sector-wide strategy based on White House guidance.
We are relying upon guidance provided in Homeland Security
Presidential Directive (HSPD)-7: Critical Infrastructure
Identification, Prioritization, and Protection, HSPD-9: Defense of U.S.
Agriculture and Food, and HSPD-10: Biodefense for the 21st Century, as
well as the guidelines under Emergency Support Function 11 (protection
of agriculture and natural resources) under the National Response Plan,
to strengthen our preparedness for intentional acts of terrorism
against food and agriculture and for enhancements to current programs
designed to prevent or control the unintentional introduction of
agents, pests, and diseases that could harm our sector.
One of USDA's key goals is to expand the surveillance and
monitoring systems to provide early detection and tracing of diseases
and outbreaks. In addition to expanding our systems, it is important to
integrate them at a higher level, enabling us to notice aberrations
across mission areas and across sectors. Intelligence is also essential
to awareness and warning so that we are knowledgeable of any
information related to potential acts of bioterrorism.
In October, 2004, when DHS officials were engaged in the design of
the NBIS and convened the first inter-agency National Biosurveillance
Group meeting to begin evaluating additional streams of data into the
system, it was clear that information related to domestic agriculture
and food safety would be critical to the overall effectiveness of the
system.
As a result of careful consideration, in February, 2005, USDA
decided to develop a new in-house Food and Agriculture Biosurveillance
Integration System (FABIS) to accomplish two primary goals: (1) achieve
the high-level integration of APHIS' animal health surveillance data
with information from the Food Safety and Inspection Service's (FSIS)
food safety and testing programs to support our homeland security
responsibilities; and (2) develop a system that also provides the NBIS
with concise, analyzed data that can be evaluated as part of a complete
assessment of U.S. biosecurity.
Currently, USDA is developing a concept of operations plan for the
FABIS. Efforts are also underway to evaluate information technology
systems, as well as upgrade and integrate the involved APHIS and FSIS
databases.
We expect to finalize the concept of operations for FABIS in the
near future, and then our efforts will turn to constructing the system
(including the necessary interface with the NBIS) and hiring analysts.
These individuals will be responsible for analyzing the surveillance
information, correlating data, making necessary connections, and
providing their assessments to USDA officials, as well as the NBIS. We
expect that the FABIS analysts will have broad experiences in, among
others, the fields of animal and plant health (epidemiology), food
safety, port operations and inspection, agriculture security, and risk
analysis and communication.
Once fully operational, FABIS will produce a comprehensive and
fully coordinated view of FSIS' and APHIS' surveillance information.
This will facilitate timely analysis of data across both agencies and
provide a common operating picture of the health of U.S. agriculture.
We expect that the results, among others, will be:
Increased situational awareness and early warning
capabilities;
Better information to assist with estimating risks to
animal--, plant--, and food-related human health, and the
agricultural economy;
Enhanced responses to recognized, emerging, or
potential threats to U.S. food and agriculture supplies;
Significant savings in terms of disease containment;
USDA and DHS Cooperative Biosurveillance Efforts
As the narrative above illustrates, USDA is pleased to have a close
working relationship with our DHS colleagues as they move forward with
development of the NBIS. USDA officials have been active participants
in the interagency planning meetings on NBIS convened by DHS. We
recognize the important benefits further coordination and analysis of
information collected by our animal health surveillance systems will
bring to our safeguarding systems, emergency preparedness, and homeland
security missions.
USDA is therefore working as expeditiously as possible to develop
the FABIS and, once operational, connect the system to the NBIS. USDA
looks forward to entering into a formal agreement with DHS in the
future that outlines how we will share information from FABIS, as well
as the kind of information we can expect to glean from the NBIS. This
agreement will also cover the detail of USDA analysts to NBIS to assist
with the examination and coordination of agriculture-related data. We
fully expect a successful partnership and, again, look forward to the
many benefits for U.S. agriculture.
Summary of USDA Animal Health Surveillance Programs
I'd like to conclude my testimony by briefly summarizing several of
APHIS' existing animal health surveillance systems that will contribute
data to FABIS and, by extension, the NBIS. I would like to note that
these systems encompass both domestic and international surveillance
efforts. Again, by closely monitoring pests and diseases, we can better
protect U.S. agriculture by adjusting our safeguarding systems, to
include, when necessary, additional border controls, enhanced domestic
surveillance, and greater emergency preparedness. I am happy to provide
more specific information on these systems and how we utilize them
following the conclusion of my testimony.
Offshore Pest Surveillance
APHIS currently maintains the Offshore Pest Information Program
(OPIP). OPIP is a structured, risk-focused process designed to collect,
synthesize/analyze, and communicate relevant offshore agricultural pest
and disease information. APHIS plant and animal health specialists
located overseas monitor and track agricultural pest and disease
situations for OPIP reporting. In addition, domestically, APHIS has the
capability to monitor pest and disease events in other countries, and
this information is added to OPIP as well. APHIS then utilizes all this
information to adjust our safeguarding systems accordingly.
Laboratory Networks
USDA coordinates three laboratory networks--the National Animal
Health Laboratory Network (NAHLN), the National Plant Diagnostic
Network (NPDN), and the Food Emergency Response Network (FERN).
The NAHLN supports APHIS' animal health testing efforts and is
comprised of State and university diagnostic laboratories (currently 49
laboratories across 48 states), which can rapidly and accurately detect
and report to APHIS possible occurrences of significant animal
diseases. NAHLN ensures sufficient capacity and timeliness in
veterinary diagnostic testing. Through a standards-based approach, the
network provides reporting for foreign animal disease agents, as well
as more routine domestic animal diseases, such as bovine tuberculosis
and brucellosis. The NAHLN electronically sends testing information to
APHIS' other pertinent databases that collect animal disease
surveillance information.
The FERN, a joint effort between USDA/FSIS and the Department of
Health and Human Services' Food and Drug Administration (HHS/FDA), is a
nationwide laboratory network that integrates existing federal and
state food testing laboratory resources capable of analyzing foods for
agents of concern. The primary objectives of the FERN include
prevention (federal and state surveillance sampling programs to monitor
the food supply); preparedness (strengthening laboratory capacity and
capabilities); response (surge capacity to handle terrorist attacks or
a national emergency involving the food supply); and recovery
(supporting recalls, seizures, and disposal of contaminated food to
restore confidence in the food supply). There are 130 laboratories
representing all 50 states and Puerto Rico that have satisfactorily
completed the FERN laboratory Qualification Checklist, which provides
vital information to determine if a lab meets the criteria for
participation in FERN and is eligible for Federal funding.
In FY 2005, FERN was able to offer cooperative agreements to 26
State laboratories, which enhanced the current capability and capacity
of the USDA and FDA laboratories participating in FERN. Of these 26
laboratories, FSIS has cooperative agreements with the 18 State
microbiological laboratories to begin to build what is, at this time, a
very limited capacity to test for biological threat agents in food,
while HHS/FDA has agreements with 8 State chemical laboratories to
develop capacity to respond to chemical attacks on the food supply. Due
to the critical importance of FERN, USDA's budget request for fiscal
year 2007 included an increase of $15.8 million for food and
agriculture defense. Of this, $13 million will go to build laboratory
capacity for FERN, and $2.5 million will be used for a repository for
analytical methods and electronic communication in real-time between
the laboratories for more rapid, timely information sharing and
response. With the $13 million FERN request for FY 2007, FSIS will be
able to ensure that the original 18 laboratories plus five additional
laboratories are fully operational FERN labs.
EMRS
The Emergency Management Response System (EMRS) is a web-based
incident management system used by APHIS during emergency situations at
the Incident Command Post level to manage and investigate outbreaks of
foreign animal diseases in the United States. In the event of such
situations, maps of real-time outbreak areas and premises data from the
EMRS can assist USDA officials in making decisions regarding the size
of quarantine zones and appropriate movement controls to prevent
further disease spread. APHIS also utilizes EMRS for information on
routine reporting of foreign animal disease investigations, State-
specific disease outbreaks or control programs, and natural disasters
involving animals.
eVe
APHIS' Emerging Veterinary Events database (eVe) is a system for
event-based animal health information. The system collects, tracks,
analyzes, and forecasts emerging animal health events. The system also
serves as an information-sharing tool. Information entered into eVe
comes from electronic open-source searches, personal contacts, field
reports, and outside communications. The open source electronic
material in eVe is mainly obtained through a data-mining effort using
sophisticated software. Analysts at APHIS' Center for Emerging Issues,
a part of the Agency's Centers for Epidemiology and Animal Health in
Ft. Collins, Colorado, run information collected from news services,
web sites, and listserves through specialized queries, manually filter
the data extracted by the queries, and save relevant animal health
event information in eVe for further sharing and analysis. This
information can also be combined with other existing animal health
information contained in the OPIP and EMRS databases to provide APHIS
officials with more complete assessments of potential animal disease
risks to the United States from sources abroad.
GDB
APHIS' Generic Database (GDB) helps to provide animal health
program management for the Agency's routine surveillance programs.
Information on cooperative Federal/State efforts such as herd health
inspections, herd certifications, vaccinations, herd inventories, and
related activities is contained in the GDB. Information on active
surveillance activities is also coupled with NAHLN data. Among other
initiatives, the GDB will soon capture routine avian influenza
surveillance data. Numerous testing programs are underway to look for
specific strains of the avian influenza virus (H5 and H7 strains) that,
if not addressed, present a risk to poultry health and can also
potentially mutate into more virulent disease strains. Aggressive
surveillance testing is being done for commercial poultry prior to
slaughter, in wild birds migrating through the United States, and
poultry that pass through live bird markets.
Conclusion
Collectively, USDA's efforts are an important part of the Federal
government's plan for the coordinated evaluation of all biosurveillance
information collected in the United States. Thank you again for the
opportunity to testify before the Subcommittee on behalf of USDA. I am
happy to answer any questions you might have regarding my testimony.
Mr. Linder. Thank you, Dr. Clifford.
Dr. Smith, are you working with any of the international
firms like FedEx and UPS and most of our major computer
manufacturers have locations over in the Far East. First of
all, they have an interest in knowing if something is going on
over there, because of their workforce, and they could pass
information on to us.
Have you considered working with them?
Dr. Smith. Mr. Chairman, that is an excellent question.
Currently, we are not. Internal to the Department of
Homeland Security, we have discussed such information sources
and the value of the commercial sources working with industry
could provide, and other private sources.
I can tell you that as we develop in this, and as NBIS
moves from standup to steady-state operation, we are looking at
open source information first, our federal source data next,
and then we will progress on specifically to the sector-
specific leading agencies. And then as we move into commercial
areas, data that might be available, these types of
relationships could and should be exploited in a better
relationship to them.
Mr. Linder. Dr. Vitko, is it on the near horizon that we
will see these BioSense or biological sensors be computerized
such that any information gets immediately transmitted via
satellite to a location, without having to go out and
physically get the test and take it to a lab?
Dr. Vitko. The answer is yes, Mr. Chairman. We expect to do
a field prototype of that system in 2007, pilot it in 2008, and
begin deploying it to the field in 2009. What it would do is do
the same kind of analysis or comparable level of analysis that
is currently done in a laboratory response network, and
wirelessly transmit to the public health system.
Mr. Linder. Dr. Besser, how are you getting real-time data
from these health institutions? Is it computerized?
Dr. Besser. Yes, sir. The way the BioSense system works, we
develop a direct relationship with a hospital, go in and
provide technical assistance, and help them to hook up their
data-stream, their existing data, so that it can flow to CDC.
Mr. Linder. Is that a good algorithm that picks up certain
kinds of spikes and things like that?
Dr. Besser. Yes. In terms of the analytic component, what
we are working on is developing the algorithm, the aberration
detection, so that we are able to look at existing clinical
data and look for events of interest that could either be a
signal for a bioterrorist event or would help give us
situational awareness to what is going on during an existing
event.
I would like to say regarding that that at the same time
that data is coming from the hospital to the CDC, it is also
going to their local health department, to their state health
department, so that we are working on this jointly.
Mr. Linder. Ms. Embrey, how are you getting your
information through ESSENCE? Is that real-time data you are
getting from these 400-some institutions?
Ms. Embrey. It comes in as it is provided. We collect it
from a central--
Mr. Linder. A written report?
Ms. Embrey. No, no. It is electronic. We receive it
electronically. We aggregate that information and provide it to
CDC about every 8 hours, daily. Sorry about that. Daily. My
expert is behind me. I apologize. Daily we provide it
electronically to CDC.
Mr. Linder. Since I have DOD and a CDC person in front of
me, I have for some time believed that all of our embassies
which have medical officers, who are not necessarily
epidemiologists or even physicians, should somehow have a basic
training in epidemiology at the CDC for 6 or 8 weeks before
they get assigned to a position overseas.
What do you think of that?
Go ahead, Rich.
Dr. Besser. I think that would be extremely valuable. I
think the more people understand epidemiology and what it can
provide, and understand public health, the more the clinical
community can be pulled in as the eyes and ears on the ground.
That would be very valuable.
Mr. Linder. Dr. Vitko, we talked about false alarms in the
BioWatch system. Can you talk about the recent tularemia
positive that we had in DC? How did we respond to that?
Dr. Vitko. Yes. In setting up BioWatch, we established very
clear algorithms of what constitutes a positive. So what we
look for are multiple signatures that indicate the presence of
an organism. So just like you would want to do identification
on person not just with their driver's license or their
baptismal certificate or stuff like that, we ask for multiple
signatures.
On the mall with the tularemia, what we had detected were
several collectors who gave us partial signatures for the
presence of that organism, but none of us gave the multiple
signatures that were required by a hit. That is the appropriate
protocol as determined by CDC, and that is the way it was.
Mr. Linder. Thank you.
Mr. Langevin?
Mr. Langevin. Thank you, Mr. Chairman.
Thank you all for your testimony. I have often said that to
be forewarned is to be forearmed, and the earlier we have
information that we need to keep our people safe, the better.
So the work you are doing is exceptionally important.
Just to build off of that question with respect to
tularemia on the Washington Mall. If you could just clarify for
me, Dr. Vitko. You would be the right person to answer to this,
I believe. I understand there was some confusion about how the
information was shared and that local Washington, D.C.,
officials were not informed of anything for approximately 1
week after detection.
Can you talk about exactly what happened and what was in
fact supposed to happen?
Dr. Vitko. Yes. What I will say is that everything that is
supposed to happen, happens, so let me tell you about the
process. As I said, it is not until all the signatures, all
multiple identifiers, I won't go into the number, but all
multiplier identifiers for the presence of the organism of
tularemia, is there a confirmed positive. On the detection of a
confirmed positive, then, notification is supposed to happen
within 2 hours of that detection and that notification.
As it turns out, not all the signatures were present. It
was not a confirmed positive, but even then because several
collectors went off, vigilant laboratory folks on the following
day said, we know this is not a confirmed positive; we should
look into it further, and they pursued that. A week later, they
still did not have a confirmed positive, but they had enough
information to notify folks and say, this occurred; we are
still chasing it down; that is where it is.
Mr. Langevin. Thank you.
The electronic surveillance system for early community-
based epidemics, as you were just referring to, Dr. Embrey, the
ESSENCE program, is designed to bring together health indicator
data from both military and civilian communities. By evaluating
the nontraditional data sources, new analytical techniques are
developed to identify abnormal health conditions. This has been
expanded to include data from purchases of medicines at
pharmacies and mental health areas after a stressful terrorist
attack.
I agree with this idea, and I basically offered this idea
as an amendment to a bill that we were working on regarding
BioShield, but because it referred to the national
biosurveillance integration system, NBIS, it was outside the
scope of the bill.
So my question is, do you think that this kind of
information should be tracked as part of NBIS?
You might take that on, Dr. Embrey and Dr. Smith. You might
want to both address this.
Ms. Embrey. I can speak for DOD. We find it to be quite
valuable at the local level to help those individuals take
action locally as appropriate.
With respect to NBIS, I defer to the DHS.
Dr. Smith. Yes, sir. In my opinion, I believe that all
sources of biosurveillance information streams, with the proper
interpretation and understanding, would be incredibly valuable
to give us a national integrated biosurveillance picture. So in
short, I would say, yes, it would be very valuable.
Mr. Langevin. Thank you.
I guess the last question that I have is, could you advise
us of other things that we could and should be doing to enhance
biosurveillance? As professionals in the field, are there
things that you need, that Congress could be doing to support
you and your efforts, to make sure this biosurveillance effort
is as robust as possible?
Dr. Smith, do you want to start and go right down the line?
Dr. Smith. Yes, sir. I think that as we continue to develop
a culture of trust that I have mentioned, as we continue to
develop the relationships that we have between the agencies, as
we learn to appreciate the sensitivities of each other's data
and information and how to treat that, I think that we
understand the problems faced at this time, and understand what
our mission is, and the wisdom of the White House and the
Congress to enact and conceptualize the national
biosurveillance integration system.
I feel like we need to continue to move out smartly and in
all cases examine where we can accelerate the pace and to move
out on the best course, and continue to move quickly. That
would be my only advice on how we could improve.
Mr. Langevin. Thank you.
Dr. Vitko, do you have any observations?
Dr. Vitko. Actually, I think this hearing is a very good
step that you have taken to do. It clearly communicates to us
the import that you put on the system and the support that we
have for doing it. To me, that is a very important piece of the
information.
Dr. Besser. Thank you very much for that question.
CDC has been receiving extensive support from Congress and
the American people for implementing national electronic
surveillance, and we greatly appreciate that support.
An important component of that is the development of
national standards for data transmission such as has been done
as part of the BioSense project in conjunction with the
American health informatics community, AHIC. We appreciate the
support Congress has given to that process.
This hearing in particular, asking us to discuss how we are
working jointly with DHS, I think is very important.
Mr. Langevin. Ms. Embrey?
Ms. Embrey. Two observations.
One, I think that we need to do a better job of aligning
what we do in the human world with what is being done in the
animal world, and make sure that there is close and effective
relationship between the information we are getting and how we
act on it.
The second would be, it is important for the federal
interagencies to work together, but I do believe we need to
have as very close partners the states--the public health
infrastructures there and the counterterrorism organizations
that exist and recommend to the governors.
They have an important role in all of this, and I think we
need to maintain a continuous dialogue with the states on what
they believe their needs are and make sure that we are
addressing not only their needs, but the nation's needs.
Dr. Clifford. I would just like to second what has been
said here. I think it is the development of relationships and
trust and the proper utilization of the data, and make sure
that there is a good understanding of the purpose and the use
of that data between each of us, both at the national level and
definitely at the state levels.
Mr. Langevin. Thank you all for those observations. I
appreciate it.
Thank you.
Mr. Linder. Mr. Gibbons?
Mr. Gibbons. Thank you very much, Mr. Chairman,
And to our panel, welcome to the committee. We are very
pleased at your presence here today and your testimony.
Let me ask a very brief question because I see the
government sitting here, everything from the Department of
Agriculture, the Department of Defense, Homeland Security, CDC.
Does the national biosurveillance integration system contain
private sector people in it as well? Or are you just one big
organization of government groups?
Dr. Smith. Thank you for that question. I think that is a
very good question.
Certainly, as I describe the progression of the standup of
the national biosurveillance integration system, the initial
data-streams will be open source, are open source. And next, we
are integrating federal source data.
In terms of involvement of the private sector, the proper
entry for private sector people and information is through the
leading federal sector. So for agriculture, the Department of
Agriculture would be the appropriate entry point for private
sector of agricultural companies, people, organizations. Public
health would be through the CDC.
So in terms of participation at a lower level feeding up
through federal agencies, yes, there is currently.
Mr. Gibbons. Over the course of the information you get,
which I am sure is tremendous in its volume because you are
taking in information from a great number of organizations
whose tentacles reach out to a great number of communities of
interest to all of this, do you have automated analytical
services to look at this?
In other words, is it gone through by human eyes only, or
do you have a computer data approach analysis to what you are
seeing when you collect and look at this information? How is
that done?
Dr. Smith. Sir, currently there is no automated analysis of
this data other than what is provided from the federal source
data or from the open source information. We are in a pilot
information management system mode at this time.
Once there is a stand-up of the full information management
system for NBIS and we begin implementing that, there will be
computer analytical automated systems put in place very slowly,
very carefully, always with a human mind and interpretation
there overseeing, not just trusting what the machine says, if
you understand.
But primarily, the interpretation and analysis, it will be
done in cooperation primarily by the lead federal agencies for
that information for that.
Mr. Gibbons. Knowing, from a layman's point, there are
limits to the effectiveness of the analysis based on just
requirements. Take, for example, privacy. A lot of the records
and information you are going to get comes from medical
records. There is an issue of privacy.
What limit does that place on your ability to do your
analysis?
Dr. Smith. Certainly, respectfully, I don't believe that
that places a limit upon on NBIS to perform analyses, whether
human eyes, human mind, or in an automated fashion. The
specific lead agencies, public health information, private
information from the CDC, those people understand the HIPAA
restrictions. They understand and appreciate these.
That is why we work with them in regard to that, and I
would defer actually to Rich to pick up with that limitation.
We fully appreciate those limitations, but they will not
inhibit the interpretation and analysis in the broader global
integrated sense of the fusion of that information.
Mr. Gibbons. Dr. Besser, do you have a response to that?
Dr. Besser. Yes, Congressman Gibbons. Thanks for that
question.
To pick up on your first point about the private sector and
that data source, CDC has been involved in many discussions
through the CDC corporate roundtable. We view the private
sector as a very strong and important partner in this area and
a potential source for very useful data about situational
awareness in the international setting, information on employee
absenteeism and things going on on the ground in areas where we
just don't have the eyes and ears.
BioSense, what I have been talking about here, is one
component of many surveillance activities that are under way at
CDC. The HIPAA issue is an important one. CDC, as a recognized
public health entity, is able to receive information from other
public health sources, and we can analyze that data and provide
aggregate data to others.
As part of BioSense, we enter into direct agreement with
hospitals in terms of what information will be shared and with
whom. That does not prohibit us from analyzing data and sending
the analysis forward. It would require us to revisit those
agreements if we were sending raw data that contained patient
identifiers and specific personal information.
Mr. Gibbons. Thank you, Mr. Chairman.
Mr. Linder. Dr. Christensen?
Mrs. Christensen. Thank you, Mr. Chairman.
Thank you for your testimony, to our witnesses.
One of the concerns that always comes up is who has
responsibility, who is accountable for certain things. My first
question would be, which agency has overall responsibility for
detecting potential pathogens, like anthrax, in the
environment?
We heard during the Government Reform Committee hearing on
Tuesday that there was some confusion about this. Keith Rhodes
of GAO testified that he had no doubt in the law and
practicality that the Department of Homeland Security should be
in charge. But Susan George, deputy director to Dr. Vitko, said
that DHS was operating under a homeland security presidential
directive 10, which, in their reading, places EPA, which is not
at the table, their administrator, in charge.
Can someone help me clarify that? Which agency is overall
in charge?
Dr. Vitko. I will try to help you clarify that.
HSPD-10 has four key pillars. One of them is surveillance
and detection. In there, it has two main activities, one is
attack warning; the other is attribution. In both of those
areas, DHS is given the lead for coordination of the activities
among the agencies.
So for attack warning, that is, has an agent been released
in the environment, in the food supply and whatever, DHS has
the lead responsibility for coordination.
Part of the confusion that came up in the hearing on
Tuesday was over--
Mrs. Christensen. And for detecting it?
Dr. Vitko. For detecting it, yes.
Mrs. Christensen. Okay.
Dr. Vitko. That is for detecting a release, as opposed to
going in and asking, is a building contaminated or not. And
that is where the confusion came up. So yes, DHS clearly has
the responsibility for attack warning.
Mrs. Christensen. Okay.
Dr. Smith, you talked about three pillars, the NBIS that is
going to be set up by mid-next year, as I understand it, your
information system, which has a contract, and the request for
proposal is out. The second one was experts, and the third part
was the relationship, that core of trust that you talked about.
We know how problematic that has been since Homeland
Security has been set up, but I am going to focus on the second
one. The NBIS won't be up for more than 6 months.
Do you have your full staff of experts in place?
Dr. Smith. No, ma'am, we do not at this time have our full
staff of experts. As we have moved through the stand-up
phases--
Mrs. Christensen. What percent of your staff do you have?
Dr. Smith. As we have moved through the stand-up phases of
the NBIS program, we have averaged between 10, 15 to 20
employees, depending upon which phase of the operation we were
standing up. I anticipate that as we continue to move to first
functionality, and then full functionality, that we will end up
with somewhere between 25 to 30 employees, with a small
fraction of those full-time employees, full-time-equivalent
FTEs.
I would estimate at this time that we have between 10 and
20 percent of our full complement of subject-matter experts.
This is a little bit difficult. I don't dodge your question,
but I tend to consider reach-back to subject-matter expertise
both within the Department of Homeland Security and also
through the partner agencies.
If I can just be personal and candid, at this time we have
reached back through Dr. Clifford's organization, to the
Department of Agriculture when we had some things to discuss
that are inappropriate to discuss in this forum.
As well, I have picked up the phone and called Rich Besser
at the table here and discussed with him, and with Rich Meyer,
who is also a colleague of his at the CDC.
So I hope I addressed your question.
Mrs. Christensen. So perhaps the coordination and the
relationships are working better than they used to in our
experience at the department?
Dr. Smith. I would be hesitant to give a retrospective, but
I can tell you that I am enjoying tremendous relationships with
these individuals as we continue to build the culture of trust
between the Department of Homeland Security and our interagency
partners.
Mrs. Christensen. Okay.
Dr. Smith and Dr. Besser, was NBIS or BioSense used to
track the recent mumps outbreak, and if so how did that work?
Was there a response triggered?
Dr. Smith. I can say certainly that the NBIS personnel were
aware of this. I can say that it was on our radar screen, if
you will, but I will defer any details of that, of course, to
Dr. Besser.
Dr. Besser. Thank you, Congresswoman Christensen.
The BioSense system was not used for tracking mumps.
BioSense is in its infancy and at this point doesn't have the
number of institutions where it would add to what we are
getting from clinical diagnosis.
When it comes to surveillance, there is no system that is
going to replace the astute clinician on the ground. Something
like mumps is something that in general will not lead to a
hospitalization. It will be seen in a doctor's office.
So our regular reporting system and our alert systems have
been what has been most useful for tracking that epidemic.
Mr. Linder. Mr. Dicks?
Mr. Dicks. Thank you. I regret that I was not here for all
of the testimony, but I do want to ask a couple of questions.
First of all, the BioNet program, Ms. Embrey, you are
involved in that, right? The Department of Defense?
Ms. Embrey. The Department of Defense is engaged in BioNet,
yes, with other agencies.
Mr. Dicks. Okay. Let me just ask you something. The BioNet
program was intended to develop interoperable military and
civilian concepts of operations and integrate military and
civilian capabilities to detect and characterize a biological
event. It provides common situational awareness to ensure
timely, effective, and consistent response actions. BioNet is a
collaboration among Navy Region Southwest.
Why is it only in one part of the country?
Ms. Embrey. I believe it was a pilot project.
Mr. Dicks. So it is a pilot project.
Dr. Vitko. I can speak to that definitively.
Mr. Dicks. Yes, go ahead.
Dr. Vitko. It is, in fact, a pilot project between the DOD
and the civilian side, funded by DHS, executed by DTRA, the
Defense Threat Reduction Agency, and it was piloted in the San
Diego area because both civilian and military had detection
capabilities there.
The idea was that they shouldn't be stovepiped; that if
something happened in the community, whether on the base or
elsewhere. So that was to develop a--
Mr. Dicks. What is it supposed to do?
Dr. Vitko. What it was supposed to do is actually to
develop an initial template to say, this is how it could work,
and then generalize that to other bases and commands and
cities.
Mr. Dicks. Well, it is because you have a very large
military population and a very large civilian population.
Dr. Vitko. Absolutely.
Mr. Dicks. By that, I mean civilian government workers. I
just didn't want anybody to forget that in the Pacific
Northwest, we have some Navy installations up there as well.
Dr. Vitko. Exactly, and we think it needs to be extended to
the rest of the country.
So one of the things that was in part an outgrowth of that,
and part of something else, we also--under this question that
Congresswoman Christensen asked about, our leadership role--we
led the formulation of this memorandum of understanding on
coordinated biomonitoring among the five agencies, DOD and DHS
being two of those five. And for all that, it calls for the
development of these integrated CONOPS and architecture as
well. So it should expand to the Northwest.
Mr. Dicks. Then you have ESSENCE, which is designed to
bring together health indicator data from both military and
civilian communities. What do we get from ESSENCE? Why is this
important?
Ms. Embrey. It provides us the information about the
symptoms of outpatients, as well as the data about cold
medications and other kinds of things, what they are buying at
drug stores, some other things to help us understand earlier
than people showing up at the doctor's office what is going on
generally with the health of that population. It provides us
just a little bit earlier indication of something going on in a
community.
Mr. Dicks. Now, I missed BioWatch, the part about what this
is. Apparently, you have 4,000 atmospheric monitoring stations
to detect atmospheric pollutants in 30 U.S. cities. But it is
not real-time.
Why is that? I notice that veterinarians collect their
information in real-time. Why is it that we can't do real-time
for BioWatch? Are we trying to move toward real-time?
Dr. Vitko. We are trying to move toward every several hours
in an automated fashion. BioWatch represents a family of
systems which detect the agent in plenty of time to begin
treatment to mitigate its effects. It is limited by the
technology that currently exists. We are developing new
technology to speed up those times.
Mr. Dicks. How can we have real-time in the veterinarian
field? Dr. Clifford, are you the veterinarian here?
Dr. Clifford. Yes, sir. I think it depends somewhat on what
we refer to as real-time.
Mr. Dicks. What ``real-time'' means.
Dr. Clifford. Yes, sir. I think, for example, I some areas
when we are talking about surveillance activities and
collection of samples, we are talking about real-time as far as
testing and techniques, you know, with hours versus days.
Mr. Dicks. But 4 hours I think certainly would be adequate.
I mean, if you have tests coming in, test results every 4
hours, I mean, you are going to pick up on something if it is
significant right away.
Dr. Vitko. Absolutely.
Mr. Dicks. What are your major concerns? What areas are you
worried about in terms of what needs to be covered out there?
What are the problem areas that you have in this emerging
system to detect with these various sensors? What are you
worried about?
Dr. Vitko. In the case of the next generation of BioWatch?
Mr. Dicks. Right.
Dr. Vitko. There are several key factors that drive the
design. One is we want to expand the range of agents from where
they currently are, to handle a larger range of agents. But the
biggest driver is in fact to have this fully automated system,
so we can get the human out of the loop. That will reduce the
cost.
It will also make it accessible to smaller cities and
towns, not just because it costs less, but because it doesn't
have to then be near a laboratory response network. The way the
system currently works, air is collected on a filter like a
little vacuum cleaner filter. The filter is manually picked up,
driven over to a laboratory response network, because you want
to use very precise assays that don't have false alarms with
them, to analyze. So to be useful, it has to be in proximity to
an LRN.
When we go to a fully automated system, it will do a
comparable kind of analysis, but instead of picking up the
filter, it will wirelessly transmit that signal to the public
health laboratory, and the same technical folks that could
interpret that signal will be able to see it and act on it
promptly. That means it could be placed in a building, in a
local community, anywhere where you establish correct
protocols.
So making it a fully automated system in a cost-affordable
way and qualifying the assays so that you have the same
confidence for what is done in the field as you do in one of
these very well-controlled laboratories is what we are working
the technology to do.
Mr. Dicks. Do you have any problem working with the
Department of Defense?
Dr. Vitko. No. We work extremely well with the Department
of Defense. As you heard, we have the BioNet joint pilot
exercise. We just held a review of my program this past week in
which we had three to four DOD participants across that. I meet
monthly in a teleconference with the head of the DTRA Chem-Bio
program. We all work through an interagency community and we
have these established MOUs.
Mr. Dicks. Good. Well, it sounds very positive. And when it
is homeland security, it is very nice to have something very
positive.
Thank you.
Dr. Vitko. We thank you for that.
Mr. Linder. Thank you. Thank you all.
This hearing is adjourned.
[Whereupon, at 3:12 p.m., the subcommittee was adjourned.]