[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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                     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

                              ----------                              
                                                                   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

                              ----------                              


                         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.]

                                 
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