[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]



 
                       IMPLEMENTING THE NATIONAL
                            DEFENSE STRATEGY

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


                                HEARING

                               before the

      SUBCOMMITTEE ON PREVENTION OF NUCLEAR AND BIOLOGICAL ATTACK

                                 of the

                     COMMITTEE ON HOMELAND SECURITY
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION

                               __________

                             JULY 28, 2005

                               __________

                           Serial No. 109-38

                               __________

       Printed for the use of the Committee on Homeland Security
                                     
[GRAPHIC] [TIFF OMITTED] CONGRESS.#13

                                     

  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html

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                     COMMITTEE ON HOMELAND SECURITY

                 Christopher Cox, California, Chairman

Don Young, Alaska                    Bennie G. Thompson, Mississippi, 
Lamar S. Smith, Texas                Ranking Member
Curt Weldon, Pennsylvania            Loretta Sanchez, California
Christopher Shays, Connecticut       Edward J. Markey, Massachusetts
Peter T. King, New York              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

                                 ______

      SUBCOMMITTEE ON PREVENTION OF NUCLEAR AND BIOLOGICAL ATTACK

                     John Linder, Georgia, Chairman

Don Young, Alaska                    James R. Langevin, Rhode Island, 
Christopher Shays, Connecticut       Ranking Member
Daniel E. Lungren, California        EdwarD J. Markey, Massachusetts
Jim Gibbons, Nevada                  Norman D. Dicks, Washington
Rob Simmons, Connecticut             Jane Harman, California
Bobby Jindal, Louisiana              Eleanor Holmes Norton, District of 
Michael McCaul, Texas                Columbia
Christopher Cox, California (Ex      Donna M. Christensen, U.S. Virgin 
Officio)                             Islands
                                     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:
  Oral Statement.................................................     1
  Prepared Statement.............................................     2
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....     3
The Honorable Bennie G. Thompson, a Representative in Congress 
  From the State of Mississippi, and Ranking Member, Committee on 
  Homeland Security..............................................    55
The Honorable Donna M. Christensen, a Delegate in Congress From 
  the U.S. Virgin Islands........................................    48
The Honorable Norman D. Dicks, a Representative in Congress From 
  the State of Washington........................................    52
The Honorable Jane Harman, a Representative in Congress From the 
  State of Texas.................................................    59
The Honorable Bobby Jindal, a Representative in Congress From the 
  State of Louisiana.............................................    57
The Honorable Edward J. Markey, a Representative in Congress From 
  the State of Massachusetts.....................................    63
The Honorable Michael McCaul, a Representative in Congress From 
  the State of Texas.............................................    54
The Honorable Eleanor Holmes Norton, a Delegate in Congress From 
  the District of Columbia.......................................    60
The Honorable Christopher Shays, a Representative in Congress 
  From the State of Connecticut..................................    47
The Honorable Rob Simmons, a Representative in Congress From the 
  State of Connecticut...........................................    50

                               Witnesses

Dr. Tony Fauci, Director, National Institute of Allergy and 
  Infectious Diseases, National Institutes of Health Department 
  of Health and Human Services:
  Oral Statement.................................................    25
  Prepared Statement.............................................    26
Dr. Julie Gerberding, Director, Centers for Disease Control and 
  Prevention, Department of Health and Human Services:
  Oral Statement.................................................     5
  Prepared Statement.............................................    13
Brigadier General Eric B. Schoomaker, Commanding General, U.S. 
  Army Medical:
  Oral Statement.................................................    30
  Prepared Statement.............................................    32
Dr. John Vitko, Director, Biological Countermeasure Portfolio, 
  Science and Technology Directorate, Department of Homeland 
  Security:
  Oral Statement.................................................    33
  Prepared Statement.............................................    35

                             For the Record

Letter from Dr. Julie Gerberding.................................    75


                       IMPLEMENTING THE NATIONAL



                          BIODEFENSE STRATEGY

                              ----------                              


                        Thursday, July 28, 2005

             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 2:00 p.m., in 
Room 1309, Longworth House Office Building, Hon. John Linder 
[chairman of the subcommittee] presiding.
    Present: Representatives Linder, Shays, Simmons, Jindal, 
McCaul, Langevin, Markey, Dicks, Harman, Norton, Christensen 
and Thompson.
    Mr. Linder. The hearing will come to order. Please be 
seated--our guests.
    The Committee on Homeland Security, Subcommittee on the 
Prevention of Nuclear and Biological Attack is hearing today 
testimony of implementation of the National Biodefense 
Strategy. I want to welcome our guests and thank them for 
appearing this day. I look forward to hearing each of your 
unique contributions to implementing a National Biodefense 
Strategy and especially your efforts to prevent a bioterrorism 
event from occurring in the first place.
    Throughout history, infectious diseases have been a 
constant for civilization. However, al-Qa'ida's intentions have 
added a decidedly sinister aspect to natural diseases and 
engineered organisms. The reason this subcommittee puts a 
premium on preventing a bioterrorism attack is simple. Even a 
limited attack would have tremendous human costs, not just in 
this country but around the world. And the social and economic 
disruption can be catastrophic to our way of life. One only has 
to look at the SARS outbreak to begin to appreciate this 
impact. Experts estimated the economic impact of the 6-month 
SARS epidemic on the Asia-Pacific region to be approximately 
$40 billion. In Canada, where 43 people lost their lives, the 
cost to the nation's economy was $419 million. The cost to the 
Ontario health system alone was $763 million. The SARS outbreak 
also had a substantial impact on the global airline industry. 
Flights in the Asian Pacific area decreased by 45 percent.
    We are mindful of the recent bombings in London and Egypt, 
which clearly demonstrate the persistent intent of terrorists 
not just to harm us but also our key allies. Conventional means 
are low-hanging fruit for terrorists. However, as technology 
hurdles to acquiring and modifying biological agents continue 
to fall, we must leverage this country's superior science and 
technological capabilities against bioterrorism.
    The administration and Congress have responded forcefully 
to this threat by making biodefense a top homeland security 
priority. We have done so by creating a blueprint for a 
coordinated National Biodefense Program, dramatically 
increasing funding for biodefense, research, surveillance and 
response activities, and encouraging the development of new 
vaccines, drugs and medical devices to combat deadly pathogens. 
However, these priorities are a joint effort within the 
government. Bureaucracies find it much easier to reinvent the 
wheel instead of collaborating and sharing resources and 
information. Therefore, it is critical to the biodefense 
efforts that the programs that each of you represent be 
seamlessly leveraged to prevent and, if it does occur, maximize 
our recovery from a bioterrorist event. Otherwise, the 
consequence is not 3,000 deaths but 30,000 or more.
    The wide range of possible biologic agents makes it 
impossible to anticipate every conceivable attack. And, as 
science advances and biotechnology spreads, the list of 
possible agents will continue to evolve. Both of these facts 
bring us to two irreducible points: people and intelligence. If 
we are to be successful in mounting a defense against 
bioterrorism, every aspect of our strategy must utilize to the 
maximum extent possible the capability of the intelligence 
community, and each of your efforts must be closely coordinated 
with the IC. Science, tools, reagents and technology may be 
ubiquitous; scientists, however, are not. We have to do a 
better job of keeping track of those individuals with skill 
sets that are attractive to potential terrorists.
    The threat of terrorism and terrorists will remain with us 
for the foreseeable future. However, the civilized world 
outnumbers them. The capabilities that each of your programs 
represent must outsmart them. If we remain committed to 
sustaining our collaborations and building a defense that makes 
us safe from bioterrorism, we also build for this Nation an 
enduring scientific and medical preparedness capability.
    Thank you again to our witnesses for being with us today. I 
look forward to hearing the progress each of your key agencies 
and programs have made to our Nation's biodefense.
    And I now recognize my partner, the ranking member, Mr. 
Langevin.

                 Prepared Statement of Hon John. Linder

    I would like to welcome and thank our distinguished panel of 
witnesses for appearing today before this Subcommittee. I look forward 
to hearing each of your unique contributions to implementing the 
National Biodefense Strategy and especially your efforts to prevent a 
bioterrorism event from occurring in the first place.
    Throughout history, infectious diseases have been a constant for 
civilization. However, al-Qa'ida's intentions have added a decidedly 
sinister aspect to natural disease and engineered organisms. The reason 
this Subcommittee puts a premium on preventing a bioterrorism attack is 
simple--even a limited bio-attack would have tremendous human costs, 
not just in this country, but around the world, and the social and 
economic disruption can be catastrophic to our way of life.
    One only has to look at the SARS outbreak to begin to appreciate 
this impact. Experts estimated the economic impact of the six-month 
SARS epidemic on the Asia-Pacific region to be approximately $40 
billion. In Canada, where 43 people lost their lives, the cost to the 
nation's economy was $419 million. The cost to the Ontario health care 
system alone was $763 million. The SARS outbreak also had a substantial 
impact on the global airline industry--flights in the Asia-Pacific area 
decreased by 45%.
    We are mindful of the recent bombings in London and Egypt, which 
clearly demonstrate the persistent intent of terrorists not just to 
harm us, but also our key allies. Conventional means are low hanging 
fruit for terrorists. However, as technology hurdles in acquiring and 
modifying biological agents continue to fall, we must leverage this 
country's superior science and technological capabilities against 
bioterrorism.
    The Administration and Congress have responded forcefully to this 
threat by making biodefense a top homeland security priority. We have 
done so by:
     creating a blueprint for a coordinated national biodefense 
program;
     dramatically increasing funding for biodefense research, 
surveillance, and response activities; and
     encouraging the development of new vaccines, drugs, and 
medical devices to combat deadly pathogens.
    However, these priorities are a joint effort within the government. 
Bureaucracies find it much easier to re-invent the wheel instead of 
collaborating and sharing resources and information. Therefore it is 
critical to the biodefense efforts that the programs that each of you 
represent be seamlessly leveraged to prevent, and if it does occur, 
maximize our recovery from a bioterrorism event. Otherwise, the 
consequence is not 3,000 deaths but, rather, 30,000 or more.
    The wide range of possible biological agents makes it impossible to 
anticipate every conceivable attack. And as science advances and 
biotechnology spreads, the list of possible agents will continue to 
evolve. Both of these facts bring us to two irreducible points--people 
and intelligence. If we are to be successful in mounting a defense 
against bio-terrorism, every aspect of our strategy must utilize to the 
maximum extent possible the capability of the intelligence community, 
and each of your efforts must be closely coordinated with the IC. 
Science, tools, re-agents, and technology may be ubiquitous. 
Scientists, however, are not. We have to do a better job of keeping 
track of those individuals with skill sets that are attractive to 
potential terrorists.
    The threat of terrorism and terrorists will remain with us for the 
foreseeable future, however, the civilized world outnumbers them. The 
capabilities that each of your programs represent must outsmart them. 
If we remain committed to sustaining our collaborations and building a 
defense that makes us safe from bioterrorism, we also build for this 
nation an enduring scientific and medical preparedness capability.
    Thank you again to our witnesses for being with us today. I look 
forward to hearing the progress that each of your key agencies and 
programs have made to our Nation's biodefense.

    Mr. Langevin. Thank you, Mr. Chairman, for holding this 
very important hearing addressing some critically important 
issues. I would like to take this opportunity to welcome our 
witnesses here today, and I look forward to hearing their 
testimony. I particularly want to welcome Dr. Gerberding back. 
It was great to visit you at the CDC, and I look forward to 
hearing what you have to say today.
    This hearing is a continuation of one we had two weeks ago. 
During that hearing, we spoke to bioweapons experts about the 
materials needed and the technical expertise required to 
produce a biological weapon and to carry out an attack.
    In contrast to the threat of nuclear terrorism, a topic for 
which this committee also has oversight responsibility, the 
solution to the biological threat is much less clear. To build 
a nuclear weapon, a would-be terrorist must acquire weapons-
grade uranium or plutonium. If we deny them this crucial 
ingredient, no nuclear weapon can be built.
    I hope, Mr. Chairman, that the work that this committee has 
done in that area will push those committees with jurisdiction 
over programs like Nunn-Lugar to further secure those materials 
more quickly.
    However, the testimony we heard last week painted a much 
different picture regarding bioterror weapons. Our witnesses 
described the rapidly shifting landscape of many possible 
pathogens that can be obtained through legitimate channels. The 
situation we are facing is one in which the increased efficacy 
of the technology used in bioengineering has lowered the bar 
such that nonexperts now have the ability to build these 
weapons in home laboratories.
    I would compare it to the improvements in computer 
technology. Ten years ago, you needed a computer expert to send 
or receive audio or video files across the Internet. Today, the 
technology does most of the work for you, and anyone can send 
these types of files.
    The Centers for Disease Control has identified over 60 
pathogens that they consider dangerous and for which they 
suggest the government procure and stockpile countermeasures. A 
good deal of the equipment needed to develop these weapons is 
readily available. Supplies such as DNA, growth media and other 
solutions can be simply ordered through the mail. The next step 
after creating the pathogen is putting it into a form where it 
can be used as a weapon and delivering the weapon to the 
target.
    Now, according to the witnesses at the last hearing, it is 
not prohibitively technically difficult to bioengineer a weapon 
by modifying its genetic structure. This presents a three-fold 
problem: First, the natural pathogen can be made much more 
deadly by including genetic instructions to produce a deadly 
toxin. The result is a bioweapon with the infection capacity of 
the original organism but with the lethality of the toxin. The 
second problem they describe is with detection. As I understand 
it, biodetectors are built to look for specific sequences and 
characteristics that identify anthrax, for example. But if 
anthrax is slightly modified, the detector would not detect it. 
Finally, I save the worst for last, our vaccines won't work on 
the organism if they have been modified for vaccine resistance.
    These problems are deadly serious, and we must move forward 
with a real sense of urgency. I want to thank the Chairman for 
holding such an important hearing, and I look forward to 
hearing from our panel.
    And I want to thank you, and I yield back.
    Mr. Linder. Members are reminded that opening statements 
may be submitted for the record.
    We are pleased to have a distinguished panel of witnesses 
before us today on this important topic. Dr. Julie Gerberding 
is the director at the Centers for Disease Control and 
Prevention at the Department of Health and Human Services; Dr. 
Anthony Fauci, director of National Institute of Allergy and 
Infectious Diseases at the National Institutes of Health for 
the Department of Health and Human Services; Brigadier General 
Eric Schoomaker, commanding general of the U.S. Army Medical 
Research and Materiel Command of the U.S. Department of 
Defense; and Dr. John Vitko, director of Biological 
Countermeasure Portfolio, Science and Technology Directorate at 
the Department of Homeland Security.
    I would like to remind our witnesses that we have a limited 
time, and all of your prepared statements are made part of the 
record, without objection, and if you could summarize in 5 
minutes, we would be grateful.
    Dr. Gerberding.

   STATEMENT OF DR. JULIE GERBERDING, DIRECTOR, CENTERS FOR 
DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN 
                            SERVICES

    Dr. Gerberding. Thank you, Mr. Chairman. And I really 
appreciate your having this hearing, and I especially 
appreciate that you and the committee took time to come to 
Atlanta and really work with us in-depth on some of these 
issues. That was a great boon to our engagement and our 
appreciation for your support.
    CDC is a very important component of our Nation's health 
protection. We have actually been in the business of 
bioterrorism since 1951 when our epidemic intelligence service 
was created in response to concerns about bioterrorism in the 
context of the Korean War. And since that time, we have 
exercised our threat detection, intervention and response 
capabilities more than 10,000 times across the United States 
and in about a thousand communities around the world.
    But as you can see from this graphic, since 9/11, the 
intensity, the magnitude, and the impact of the threats that we 
have been addressing have grown substantially in this very 
global and connected world. And we have had a series of 
operations that have been significant enough, both natural and 
terrorist in nature, to require us to step up our emergency 
operations center. And for the record, I would like to make 
note that you have copies of our slides as well as a copy of 
our exposure report and a list of our preparedness goals for 
CDC.
    In the context of threats this large, we are responsive to 
one of the failures documented in the 9/11 Commission Report, 
and that was the failure of imagination. People have trouble 
imagining things when they can't imagine how they can handle 
them. But our job at CDC and throughout the Federal Government 
is to really do that imagining, to imagine the unimaginable so 
that we can take steps to prevent the threat, or, when we can't 
prevent it, to take the steps necessary to prepare people.
    And what we really have here at this table and across the 
Federal Government and state and local communities is a network 
of prevention and preparedness that has to work in a seamless 
fashion with a clear strategy. But each of us plays a very 
unique role. So I am going to just describe for you CDC's role 
in this, recognizing full well we are just one part of the 
Department of Health and Human Services and one part of the 
overall responsible workforce in this regard.
    On the next graphic, I have listed the nine preparedness 
goals under which that CDC is operating. These goals were 
developed to prevent, detect, investigate, control, recover and 
improve our capability to deal with health threats, both 
terrorist as well as natural in nature. These goals drive the 
work done at CDC and throughout the state and local health 
systems. These goals have clear objectives, they have key 
performance measures, and we will be reporting on the progress 
toward achieving these goals over the next several months.
    On the next graphic, I have depicted one of the most 
important core capacities that CDC brings to the table, and 
that is our surveillance capacity. We do surveillance to detect 
emerging threats in all various content domains. But one that 
we are particularly engaged in right now is the capacity to 
develop real-time health protection data through communities 
across our country by tapping into health records. I am getting 
anonymous information about patients' utilization of services 
so that we can have the earliest possible warning of an 
emerging threat at the community level and we can have the 
fastest possible situation awareness about how that threat is 
progressing and how well we are managing it.
    On the next graphic, I have listed another one of our very, 
very important capacities in this regard. I mentioned 
globalization, connectivity and speed as characteristics of 
threats. CDC has international staff deployed in 43 countries 
as we speak. These individuals form a very important backbone 
of threat detection throughout our global detection system. And 
that is on the next graphic.
    You can see how we are linking our existing public health 
capabilities into a global health protection that takes 
advantage of our quarantine stations, our international field 
stations, our relationships with the business sector, our 
sentinel surveillance sites and a number of other assets to 
link our surveillance activities into the CDC bio-intelligence 
center and then to relay information from that system to 
Homeland Security and other intelligence centers so that it can 
be integrated.
    On the last graphic, I would just like to point out another 
one of our very critical core capacities. That is certainly our 
laboratory capacity. Mr. Chairman, these are four of the 
buildings that will be opening at CDC on September 12 this 
year.
    We thank you and the Georgia delegation as well as the 
Congress for their support of these buildings. But three of 
these buildings represent new state-of-the-art laboratories, 
bringing our total laboratory capacity to more than a million 
square feet. We have the national treasure for environmental 
health, the national treasure for biodefense, the national 
treasure for various laboratories related to smallpox as well 
as of course our capacity in SARS. These laboratories at CDC 
are part of our overall laboratory response network that again 
supports Homeland Security activities and other threat 
assessment and response capabilities, and I think really speaks 
to the fact that the science is behind everything that we do, 
and we are using that science not only to take threats off the 
table but also to detect, respond, and mitigate them as quickly 
as we possible can. So thank you for your support. And we look 
forward to your questions.
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    [The statement of Dr. Gerberding follows:]

             Prepared Statement of Dr. Julie L. Gerberding

    Good afternoon, Chairman Linder and Subcommittee members. I am Dr. 
Julie Gerberding, Director of the Centers for Disease Control and 
Prevention (CDC), Department of Health and Human Services (HHS). I 
appreciate the opportunity to share with you CDC's unique role and 
contributions to building national biodefense capacities, particularly 
with regard to Biodefense for the 21st Century.
    The philosophy of public health during the 20th century has been to 
prevent natural outbreaks. In the 21st Century, however this is not 
enough. The threat of terrorism necessitates 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 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 biological and other weapons threats. 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.
    T2CDC'S Strategic Preparedness Framework
    The events of September and October 2001 made it very clear that 
terrorism is a serious threat to our Nation and the world. The Bush 
Administration and Congress responded forcefully to this threat by 
providing funding to strengthen our medical and public health 
capacities to protect our citizens from future attacks. To support HHS, 
CDC has made terrorism preparedness and emergency response one of two 
overarching agency goals 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. For the purposes of this testimony each of the goals has 
been categorized according to the four essential components of our 
national biodefense program as identified in the HSPD-10.

    1. Threat Awareness:
         Decrease the time needed to classify health events as 
        terrorism or naturally occurring in partnership with other 
        agencies.
    2. Prevention and Protection:
         Increase the use and development of interventions 
        known to prevent human illness from chemical, biological, 
        radiological agents, and naturally occurring health threats.

    3. Surveillance and Detection:
         Decrease the time needed to detect and report 
        chemical, biological, radiological agents in tissue, food or 
        environmental samples that cause threats to the public's 
        health.
         Improve the timeliness and accuracy of information 
        regarding threats to the public's health as reported by 
        clinicians and through electronic early event detection, in 
        real time, to those who need to know.

    4. Response and Recovery:
         Decrease the time to identify causes, risk factors, 
        and appropriate interventions for those affected by threats to 
        the public's health.
         Decrease the time needed to provide countermeasures 
        and health guidance to those affected by threats to the 
        public's health.
         Decrease the time needed to restore health services 
        and environmental safety to pre-event levels.
         Increase the long-term follow-up provided to those 
        affected by threats to the public's health.
    In addition to these eight goals, CDC has a ninth goal under the 
heading of ``Improvement'' to decrease the time needed to implement 
recommendations from after action reports following threats to the 
public's health. Taken together these goals provide CDC 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.

    Key Activities and Accomplishments
    For the purposes of this testimony, I will now share with you CDC's 
unique blending of leadership and supporting roles under Biodefense for 
the 21st Century highlighting three priority areas:
         Laboratory Capacity
         Surveillance and Detection
         Response Capacity
    For each of these areas, I will address CDC's activities and 
accomplishments toward building these capacities at the local, State 
and Federal levels.

    LABORATORY CAPACITY
    CDC is internationally recognized as a world leader for its premier 
clinical and chemical laboratories. To help strengthen our nation's 
laboratory capacity in responding to potential terrorism threats, we 
are aggressively moving forward on several fronts.

    Laboratory Response Network Activities
    The Laboratory Response Network (LRN) is a unified network of 
domestic and international laboratories that seeks to meet the needs 
for analysis of all specimen/sample types (e.g., clinical, 
environmental, food) and agent types (e.g., chemical, biological, 
radiological). The objective of the LRN is to ensure an effective 
laboratory response to bioterrorism by helping to improve the Nation's 
public health laboratory infrastructure, through uniform diagnostic 
standards and protocols. Currently, there are more than 150 
laboratories, representing all 50 states which make up the LRN. In 
addition more than 10 Federal agencies or departments actively 
participate in supporting the LRN including CDC, Food and Drug 
Administration (FDA), United States Department of Agriculture (USDA), 
Department of Energy (DOE), Environmental Protection Agency (EPA), DoD, 
Federal Bureau of Investigation (FBI), and DHS.
    To further expand and improve national laboratory response to an 
event, the Interagency Consortium of Laboratory Networks (ICLN) is a 
network of networks which was established six months ago to promote 
collaboration, communication, and technical acuity throughout the 
government's overall response strategy. This DHS-led group includes 
representatives from HHS (including CDC), USDA, DoD, DOE, EPA, 
Department of Commerce, Department of the Interior, Department of 
Justice, and the State Department. Together, all of these lab networks 
cover the diverse biological, chemical, radiological and nuclear 
materials that may be detected in clinical, environmental or food 
samples. The ICLN envisions a US homeland security infrastructure with 
a coordinated and operational system of laboratory networks that 
provides timely, high quality, and interpretable results for early 
detection and effective consequence management to acts of terrorism and 
other events requiring an integrated laboratory response.

    National Interagency Biodefense Campus Initiative
    The National Interagency Biodefense Campus (NIBC) is standing up at 
Fort Detrick to leverage and expand key competencies to achieve 
productive and efficient interagency cooperation in support of Homeland 
Security Biodefense. The co-location and collaboration of partners from 
DoD, HHS, DHS, and USDA provides a unique opportunity for coordinating 
and synchronizing areas of common interest among the federal agencies 
involved in medical research and/or biotechnology related to 
biodefense. The confederation of members promotes federal interagency 
coordination in facilities planning, technology sharing, and sharing of 
expertise, while minimizing duplication of effort, technology, and 
facilities.

    CDC's Environmental Health Laboratory
    CDC and the Agecy for Toxic Substances and Disease Registry (ATSDR) 
is responsible for detecting, responding to, and preventing human 
illness caused by a chemical release. Highlights of our accomplishments 
include:
         Developing a Rapid Toxic Screen to analyze human blood 
        and urine samples for 150 chemical agents likely to be used in 
        chemical terrorism.
         Assisting local, state, and federal agencies during 
        national and international chemical terrorism events, providing 
        chemical and toxicologic expertise, etiologic chemical 
        analysis, and clinical guidance.
         Helping to increase state and local chemical lab 
        capacity through funding, technical assistance, training and 
        the conduct of drills and exercises.
         Supporting surveillance for chemical terrorism events 
        through the American Association of Poison Control Centers' 
        Toxic Exposure Surveillance System (TESS), which monitors and 
        analyzes real-time data from the nation's poison-control 
        centers.
    Select Agent & Toxins Program
    Through the Select Agent and Toxins Program within CDC, HHS 
regulates the possession, use, and transfer of 39 biological agents and 
toxins that have the potential to pose a severe threat to public health 
and safety. The CDC Select Agent and Toxins Program oversees these 
activities and registers all laboratories and other entities in the 
United States that possess, use, or transfer a select agent or toxin.
    Currently there are 333 entities registered with the Select Agent 
and Toxins Program including academic institutions; biomedical centers; 
commercial manufacturing (e.g., the pharmaceutical industry) or 
distribution facilities; federal, state, and local laboratories 
(including clinical and diagnostic laboratories); and research 
facilities.
    Similarly, USDA has the responsibility of regulating pathogens that 
affect animals or animal products, plants or plant products. CDC 
collaborates with USDA to ensure that both regulations are harmonized 
and consistent.

    SURVEILLANCE AND DETECTION
    Historically, CDC has engaged in environmental and biological 
surveillance to track and respond to natural or unintentional man-made 
threats to the public's health. Because of this tradition, CDC has 
well-established partnerships with state, local and Federal agencies 
involved in bio-surveillance. These partnerships are being 
significantly expanded in the area of active reporting as well as 
exploring new methods of biologic threat detection domestically and 
globally.
    BioWatch Preparedness and Response
    A new system of providing around the clock detection capability is 
the BioWatch environmental surveillance program. This program utilizes 
automatic biohazard detection sensors placed strategically across the 
nation to detect potential threats to the public's health. CDC is 
working in tandem with the DHS, DOJ, and the EPA in the implementation 
of this program. These agencies have jointly developed draft guidance 
for BioWatch Preparedness and Response. This guidance is a three part 
tool that clearly articulates protocols and procedures for BioWatch-
specific environmental sampling and response.
    BioSense
    BioSense is a significant expansion of information that CDC has 
traditionally collected from Federal, state and local reporting 
sources. It is a comprehensive public health data mining activity that 
integrates traditional and novel sources of public health data to 
enhance detection, quantification, and localization of possible 
bioterrorism attacks and outbreaks. In addition, it directly supports 
epidemiological investigation, event containment, and emergency 
response and recovery operations.
         BioSense also provides Early Event Detection (EED) and 
        Situational Awareness (SA) capabilities to state and local 
        public health departments, and specifically to cities where 
        BioWatch sensors have been deployed. There are approximately 
        400 users enrolled representing 49 states, one territory, and 
        34 major metropolitan areas. Current data sources include DoD 
        and Veterans Affairs (VA) ambulatory care data, laboratory test 
        orders from Lab Corp Corporation, and BioWatch sensor results.
         BioSense continues to refine and expand this important 
        data resource and is currently collaborating with the EPA on 
        the potential use of water system testing data as another 
        source for Early Event Detection as well as with DoD and the VA 
        in strengthening their detection capacity through the 
        utilization of BioSense data.
    Biological Threat Characterization Program
    CDC is an active participant in the Biological Threat 
Characterization Program (BTCP) which is a component center of the 
National Biodefense Analysis and Countermeasures Centers (NBACC) within 
DHS. A number of Federal agencies participate in this program including 
the FBI, CIA and DoD. BTCP has been tasked to provide bi-annual risk 
assessments for biological threat agents of concern. CDC subject matter 
experts are providing technical input to this process and will 
participate in the review of the final results.
    Global Disease Detection
    CDC is renowned as an international public health agency. Medical 
doctors, researchers, and epidemiologists from around the world contact 
CDC for advice on the evaluation and diagnosis of patients feared to 
have bioterrorism-associated or emerging infectious diseases. CDC staff 
are available twenty four hours a day, seven days a week to provide 
telephone and on-line consultations.
    The Global Disease Detection initiative aims to recognize 
infectious disease outbreaks faster, to improve the ability to control 
and prevent outbreaks, and to detect emerging microbial threats. CDC 
will continue implementing a comprehensive system of surveillance by 
expanding the Emerging Infections Program and the Field Epidemiology 
and Laboratory Training Program. This network is a phased approach that 
requires ongoing support for existing country/regional platforms while 
bringing a high level of focus and attention to develop new sites. An 
effective network will have a strategic presence across the globe with 
an information technology and laboratory infrastructure that would 
allow for the broadest possible detection and response capacities 
before a significant event occurs. Additional activities include 
improving early warning systems; researching new viral strains; aiding 
in collaborations with multinational organizations; and augmenting 
surveillance.
    Recently CDC experts have assisted in ruling-out smallpox in a 
patient in Africa, and in providing injury checklists to help evaluate 
victims of the London terrorist bomb attacks.
    CDC also has provided direct, in-country technical and operational 
support to large-scale international activities, such as the 2004 
Summer Olympics in Athens, Greece.

    RESPONSE CAPACITY
    CDC is unique in its ability to rapidly mobilize pharmaceuticals 
and medical supplies to anywhere in the country within a 12 hour window 
from the decision to deploy these assets. In addition, our agency can 
bring to bear its formidable arsenal of scientific knowledge and 
subject matter expertise to assist in responding to and containing 
public health emergencies. Our goal is to increase this capacity even 
more with a priority focus on building response capacity at the state 
and local levels.
    Preparedness and health security are a shared Federal, state and 
local responsibility. NIH is leading the way in the development of new 
medical countermeasures to threats we face. HHS has completed contract 
awards for the acquisition by the Strategic National Stockpile (SNS) of 
several new countermeasures, including the next-generation anthrax 
vaccine, under Project BioShield. CDC, meanwhile, is working closely 
with state and local health departments, federal agencies and 
departments including FDA, HRSA, DoD and other key stakeholders to 
create a seamless response network to ensure that these countermeasures 
can be delivered in a timely and effective fashion.
    We have accomplished much but there is much more to be done. We 
continually explore options to strengthen the dispensing of 
countermeasures to save as many lives as possible in those first 
critical hours or days of a major emergency. HHS is working in concert 
with partners and stakeholders to advance the best strategies to ensure 
medical countermeasures are readily available to protect individuals in 
the event of a terrorist attack or naturally occurring health problem.

    Cities Readiness Initiative
    CRI is a multi-agency initiative spearheaded by HHS and DHS. Other 
participating agencies include DOJ, FBI, VA and the United States 
Postal Service. The intent of the Cities Readiness Initiative (CRI) 
pilot is to build capacity for catastrophic public health emergency 
response in densely populated areas. Specifically, the Cities Readiness 
Initiative is designed to significantly improve the operational 
capability of 21 large metropolitan areas to receive, distribute and 
dispense SNS assets. Each designated city should be able, in the wake 
of a bioterrorism event for which antibiotics are an appropriate 
countermeasure, to provide such prophylaxis to the known and 
potentially affected population within 48 hours of the time of the 
decision to do so.
    Under this program, 20 cities and the District of Columbia receive 
direct assistance through CDC's Public Health Emergency Preparedness 
cooperative agreement. Participating cities include: Atlanta, Boston, 
Chicago, Cleveland, Dallas, Denver, Detroit, Houston, Las Vegas, Los 
Angeles, Miami, Minneapolis, New York City, Philadelphia, Phoenix, 
Pittsburgh, St. Louis, San Diego, San Francisco, Seattle, and the 
District of Columbia/National Capitol Region.
    CDC's Division of Strategic National Stockpile (DSNS) supports this 
initiative with on-going technical assistance to ensure SNS assets are 
received and dispensed efficiently and effectively.
    CDC conducted its own internal assessments in all 21 cities at 
baseline. These preliminary assessments showed initial improvement. CDC 
is currently working with partners and a research organization to 
externally validate CDC's rating tool.

    State and Local Readiness Program
    CDC administers the Public Health Emergency Preparedness 
cooperative agreement to assist State and local public health programs 
in building and improving their preparedness capacities. This includes 
overseeing their progress in completing activities that help address 
CDC's nine preparedness goals mentioned earlier in this testimony, by 
monitoring 34 measures that have been identified as good indicators of 
public health emergency preparedness. As we learn more about effective 
methods of emergency preparedness, the development and refinement of 
these measures will be conducted in collaboration with state, local, 
territorial, and tribal public health input as well as with key 
partners including National Association of County and City Health 
Officials (NACCHO), Association of State and Territorial Health 
Officials (ASTHO), Council of State and Territorial Epidemiologists 
(CSTE), Association of Public Health Laboratories (APHL), DHS, and the 
Federal Emergency Management Agency. Note that these measures were 
initially refined through review of the Target Capabilities List from 
DHS which provides defines ``nationally accepted preparedness levels of 
first responder capabilities'' for state and local programs.
    Risk Communication
    HHS coordinates the development of Department-level training 
opportunities related to public health and medical emergency response, 
including providing training opportunities for its employees (civil 
service and uniformed) with the basic tools necessary to manage and 
operate during a public health emergency.
    CDC has developed a preparedness education strategy that targets 
public health agencies, healthcare organizations, clinicians and 
laboratorians needed to collaborate to detect, investigate, respond to, 
and recover from a public health emergency.
    One component of CDC's preparedness education strategy is directed 
to developing and providing information to public health workers and 
clinicians in advance of an emerging threat. This education is 
developed to prepare and alert clinicians and public health workers in 
advance and ``just in case'' of a potential threat in their community, 
to recognize symptoms, syndromes, or patterns of illness that require 
reporting and to improve their capacity to respond.
    In addition, CDC has invested in the development of ``just-in-
time'' educational materials, which are educational methods to provide 
prompt, emergent information as needed and as it becomes available. 
During an emergency event, CDC is able to rapidly provide new 
information to clinicians and public health professionals, as rapidly 
as possible, through web-based and live satellite broadcast educational 
programs and other communication channels, to improve response efforts.

    Conclusion
    CDC is working hard to meet the public health challenges of the 
21st century. We are redefining our mission, restructuring the way we 
conduct business, and reorienting our goals. We are changing as an 
agency because we must respond faster and more efficiently as we 
protect our nation's health in today's world.
    To succeed we rely on many partners including the medical 
community, federal, state and local governments, innovators and the 
highly talented CDC workforce. CDC's new business model allows us to be 
the nimble organization that we need to be to combat world threats to 
the public's health.
    Thank you for the opportunity to be here today. I would be happy to 
address any questions that you may have.
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    Mr. Linder. Thank you, Dr. Gerberding.
    Dr. Fauci.

STATEMENT OF TONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTES OF 
ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Fauci. Mr. Chairman, members of the committee, thank 
you for giving me the opportunity to discuss with you this 
afternoon the role of the NIH research endeavor in providing 
the fundamental and ultimately applied research that goes into 
the development of countermeasures against bioterror threats as 
well as threats that naturally occur. I would like to submit 
for the record these slides such that you might have them in 
front of you as I go through them.
    Mr. Linder. Without objection.
    Dr. Fauci. The Homeland Security Presidential Directive 10 
entitled, Biodefense for the 21st Century, has multiple 
components. The NIH research effort is associated slightly with 
some of them, but very intensively with one in particular that 
I would like to spend a couple of minutes reviewing for you: 
the development of medical countermeasures for the response and 
recovery phase as well for the preparatory phase of diagnostics 
and vaccines.
    Soon after the September 11, 2001, tragedy, followed by the 
anthrax attack on this city and New York City, we developed a 
strategic plan based on the anticipation of a considerable 
amount of resources that would be put into the preparedness and 
the research arena. So, in collaboration with our sister 
agencies, the CDC and the FDA and elsewhere, we took a look at 
how we can predict in some respects, and we use the CDC 
category A, B, and C agents, and respond in a countermeasure 
fashion to any of a number of threats. We developed a research 
agenda for these various categories, and over the past year, we 
have come out with progress reports. And I would like to very 
briefly give you a thumbnail sketch of some of the key 
achievements over the past couple of years.
    First, with regard to smallpox. The President himself had 
asked us in the Department what kind of preparation we had very 
soon after the anthrax attacks in 2001 with regard to smallpox. 
We had 18 million vaccine doses with a population of 288 
million. So smallpox vaccine was a serious problem that we 
needed to address immediately. We now have more than 300 
million doses of smallpox vaccine; but since we know there are 
uncommon but nonetheless potentially very serious toxicities 
associated with that, we now are in the developmental phase of 
a much less adverse event-related smallpox vaccine, modified 
vaccinia Ankara.
    Moving on to anthrax, we now have the next generation 
recombinant protective antigen which has been under procurement 
through the BioShield law and which in fact is now going 
through testing, showing protection against aerosolized 
challenge with anthrax. We have the first Ebola vaccine that 
has been tested in humans and have now gone on to the second-
generation vaccine which has proved to be safe and in fact 
virtually 100 percent protective in monkeys.
    Botulism toxin is another issue. We have monoclonal as well 
as polyclonal antibodies, and we are developing a more purified 
approach with monoclonal antibodies. And then finally on this 
list influenza a very important pathogen because it gives the 
link between naturally occurring pathogens and naturally 
occurring potential catastrophes and what we in the health 
community can do to link that to our preparedness to 
deliberately released microbes. And that is the preparation 
that we at the CDC and NIH and FDA are going through in 
preparedness for a potential influenza pandemic.
    And on this last visual is a map of the world showing some 
sampling of the emerging and re-emerging infectious diseases 
that we have had to deal with over the past 25 to 30 years. We 
include deliberately emerging pathogens in that group for a 
very important reason: The preparedness that allows us to 
respond to a SARS or a West Nile or a pandemic flu 
fundamentally and in principle is the same sort of preparedness 
that will allow us to respond to deliberately released microbes 
in a very comprehensive way. And it is this joining together 
that I think will hold us in the best stead to be able to 
respond to the threats ahead.
    I will be happy to answer any questions later on. Thank 
you, Mr. Chairman.
    [The statement of Dr. Fauci follows:]

              Prepared Statement of Anthony S. Fauci, M.D.

    Mr. Chairman and Members of the Subcommittee, thank you for the 
opportunity to discuss with you today the research programs of National 
Institutes of Health (NIH) aimed at developing effective medical 
countermeasures against bioterror attacks. The terrible events of 
September 11, 2001, clearly exposed the vulnerability of the United 
States to brutal acts of terrorism. The anthrax attacks that followed 
just a few weeks later made it very clear that the threat of 
bioterrorism with pathogens or biological toxins represents a serious 
threat to our Nation and the world.
    The Administration and Congress responded forcefully to this 
threat, and have made biodefense a top national security priority. 
After a comprehensive review of the Nation's biodefense activities, 
President Bush in April 2004 signed a Homeland Security Presidential 
Directive called ``Biodefense for the 21st Century'' that provides a 
detailed strategy for defending the Nation from biological attacks. 
This strategy has four pillars: Threat Awareness; Prevention and 
Protection; Surveillance and Detection; and Response and Recovery. The 
NIH was assigned the lead role in the development of medical 
countermeasures to biological attack, and in the conduct of research 
concerning potential agents of bioterrorism that directly affect human 
health. The National Institute of Allergy and Infectious Diseases 
(NIAID) is the NIH institute with primary responsibility for carrying 
out this assignment.
    In my testimony today I will discuss the NIH biodefense research 
program, some recent accomplishments in NIH biodefense research, and 
the mechanisms by which NIH coordinates its activities with other 
Federal agencies. I will close with a brief discussion of biodefense 
research to counter possible future threats from engineered microbes, 
as well as research needed to counter naturally emerging and re-
emerging infectious diseases such as influenza.

    NIH Biodefense Strategic Plan and Research Agenda
    The NIH biodefense research program is guided by a comprehensive 
strategic planning process. In February 2002, NIAID convened the Blue 
Ribbon Panel on Bioterrorism and Its Implications for Biomedical 
Research, whose members were distinguished experts from academic 
centers, private industry, civilian government agencies, and the 
military. Three key documents were developed based on this Panel's 
advice and on extensive discussions with other Federal agencies. These 
documents are: the NIAID Strategic Plan for Biodefense Research, the 
NIAID Research Agenda for CDC Category A Agents, and the NIAID Research 
Agenda for CDC Category B and C Priority Pathogens. Category A agents 
are the most dangerous microbes and toxins; these agents cause diseases 
that include anthrax, smallpox, plague, botulism, tularemia, and viral 
hemorrhagic fevers. These agents were given the highest priority 
because they: (a) are relatively easily disseminated or transmitted 
from person to person; (b) result in high mortality rates with the 
potential for major public health impact; (c) would likely cause 
significant social disruption; and (d) require special action for 
public health preparedness. Category B agents are in the second tier of 
priority. These are agents that: (a) are moderately easy to 
disseminate, (b) result in moderate morbidity and low mortality, and 
(c) require specific enhancements of national diagnostic capacity and 
disease surveillance systems. Category C Agents have the next highest 
priority. They include emerging pathogens that could be engineered for 
mass dissemination in the future because of their availability, ease of 
production and dissemination, and potential for high rates of morbidity 
and mortality and major health impact.
    The Strategic Plan outlines three distinct priority areas for the 
biodefense research program: development of infrastructure needed to 
safely conduct research on dangerous pathogens; basic research on 
microbes and host immune defenses; and targeted, milestone-driven 
medical countermeasure development to create the vaccines, 
therapeutics, and diagnostics that we will need in the event of a 
bioterror attack. The two biodefense research agendas describe short-
term, intermediate, and long-term goals for research on the wide 
variety of agents that could be used to conduct such an attack. Two 
recent progress reports describe the significant advances made toward 
the goals set forth in these research agendas. All these documents are 
available on the NIAID website at http://www.niaid.nih.gov/biodefense.
    In addition to NIAID's efforts in biodefense research, in 2004, 
DHHS tasked the Institute with the development of a research program to 
accelerate the development and deployment of new medical 
countermeasures against ionizing radiation for the civilian population. 
NIAID developed and recently released The NIH Strategic Plan and 
Research Agenda for Medical Countermeasures against Radiological and 
Nuclear Threats. This Strategic Research Plan and Agenda is organized 
into four sections: (1) basic and translational research on the 
mechanisms of radiation injury, repair, and restoration that can lead 
to the identification and characterization of new therapeutics; (2) 
bioassays and tools for biodosimetry, which will aid in diagnosis; (3) 
immediate product development of promising therapies; and (4) 
infrastructure to support the necessary research. The document is 
intended to unify and strengthen the research community focused on 
these areas, promote collaboration, and facilitate transition from 
research to product development. NIH is working closely with DHHS to 
prioritize the research and development activities in this ambitious 
agenda within the resources available and as one component of the 
larger National medical countermeasures research agenda.

    Recent Accomplishments
    Basic research into the interactions between pathogens and their 
human hosts provides the foundation for medical countermeasure 
development. For example, a major NIAID basic biodefense research 
initiative moving rapidly forward is focused on the human innate immune 
system, which is comprised of broadly active ``first responder'' cells 
and other non-specific mechanisms that are the body's first line of 
defense against infection. The delineation of methods to boost innate 
immune responses could lead to the development of fast-acting 
countermeasures that would be effective against a wide variety of 
pathogens or toxins that might be used in an attack. In order to 
develop effective ways to increase innate responses, NIAID-supported 
scientists at Scripps Institute in La Jolla, CA, are mapping the 
mechanisms by which innate immunity operates and discerning how these 
responses are triggered.
    NIH biodefense research is ultimately directed toward the 
development of new and effective medical countermeasures, including 
vaccines, therapeutics, and diagnostics against potential bioterror 
agents. Substantial progress in this area already has been achieved. In 
the area of therapeutics, for example, NIAID-supported scientists 
recently discovered that a poxvirus infection may be halted by a cancer 
drug aimed not at the virus, but at the human cellular machinery that 
the virus needs to spread from cell to cell. Although much work needs 
to be done on this concept, this research opens the possibility of 
providing a therapeutic approach to poxviruses such as smallpox and 
also of circumventing the problem of antiviral drug resistance. This 
approach might also be applicable to other viruses. Researchers 
supported by NIAID also are investigating the use of antibodies that 
can bind to and block the action of toxins produced by the anthrax and 
botulinum bacteria.
    New and improved strategies for the development of vaccines against 
potential bioterror agents are being pursued vigorously. Our stockpile 
of usable smallpox vaccines has grown enormously since 2001, when only 
90,000 doses were readily available for domestic use. Today, because of 
clinical research on the minimal dose required to produce immunity and 
due to an aggressive acquisition program, more than 300 million doses 
are held in the Strategic National Stockpile (SNS). Moreover, NIAID-
supported researchers are testing next-generation smallpox vaccines 
that may prove to be effective against the smallpox virus and safer 
than the current smallpox vaccines, thus potentially allowing them to 
be used by populations that have contraindications for currently 
available smallpox vaccines, including people with weakened immune 
systems. One of these vaccine candidates, modified vaccinia Ankara 
(MVA), is based on a strain of the vaccinia virus that causes fewer 
side effects than the traditional Dryvax vaccinia virus strain because 
it does not replicate effectively in human cells. Human trials of MVA 
vaccines are underway at NIH and elsewhere. Encouragingly, vaccine 
manufacturers Bavarian Nordic and Acambis announced this year that 
Phase I and Phase II trials have demonstrated MVA vaccine to be safe 
and immunogenic in human volunteers, complementing earlier studies by 
NIAID intramural scientists and their colleagues showing that MVA 
protects monkeys and mice from smallpox-like viruses. Additionally, 
NIAID supports a targeted research program to reduce the incidence and 
severity of eczema vaccinatum (EV), the most common life-threatening 
complication of smallpox immunization, and to protect individuals with 
atopic dermatitis from the adverse consequences of vaccinia exposure. 
The Atopic Dermatitis and Vaccinia Immunization Network conducts 
research that will identify and evaluate ways to reduce the risk of EV.
    NIAID also has made progress in the development of a vaccine to 
protect against viral hemorrhagic fever viruses that could potentially 
be used as bioterror agents. For example, research scientists at the 
NIAID Vaccine Research Center have completed enrollment of a Phase I 
human trial of a DNA-based vaccine for Ebola. Thus far, the vaccine 
appears to be safe and immunogenic.
    NIAID also has played a major role in the rapid development of the 
next-generation anthrax vaccine known as recombinant protective 
antigen, or rPA. The technology for creating this vaccine was developed 
at the United States Army Medical Research Institute for Infectious 
Diseases (USAMRIID), and NIAID has supported its advanced research and 
development. Clinical trials to evaluate rPA in healthy adults 
currently are underway. Preliminary unpublished data suggest that the 
immune responses elicited in humans are similar to those elicited in 
animal studies. Those animal studies have demonstrated that the rPA 
vaccine protected animals against aerosol challenge with anthrax 
spores. Last November, the Department of Health and Human Services 
(DHHS) awarded a contract for the acquisition of 75 million doses of 
rPA vaccine to be held in the SNS. NIAID's rPA product development 
initiatives were instrumental in making the initiative possible. 
Candidate vaccines for plague, botulinum toxin, and other agents are 
also under development.
    In addition to conducting and supporting biodefense research 
initiatives, NIH has invested in several research infrastructure 
expansion programs. NIAID has established a nationwide network of 
Regional Centers of Excellence for Biodefense and Emerging Infectious 
Diseases Research (RCEs). These Centers are now conducting fundamental 
research on infectious diseases that could be used in bioterrorism; 
developing diagnostics, therapeutics and vaccines needed for 
biodefense; and providing training for future biodefense researchers. 
Two new RCE awards were announced on June 1, 2005, bringing to ten the 
total number of RCEs nationwide. NIAID also supports five Cooperative 
Centers for Translational Research on Human Immunology and Biodefense 
to characterize human immune responses to disease-causing organisms, 
develop technologies to measure these responses, and apply this 
knowledge to design therapies that strengthen host immunity. In 
addition, NIAID supports the construction of two National 
Biocontainment Laboratories (NBLs), built to Biosafety Level 4 
standards and therefore capable of safely containing any known 
pathogen, and nine Regional Biocontainment Laboratories (RBLs) with 
Biosafety Level 3 facilities. NIAID also will support the construction 
of two additional RBLs this year. Together, these high-level research 
laboratories, some of which are already under construction, will 
provide the facilities needed to carry out the Nation's expanded 
biodefense research program with the highest degree of safety and 
security.

    Coordination of NIH-Supported Medical Countermeasures Research
    Although NIH is a leading agency in government-sponsored research 
to develop medical countermeasures against biological threats, it is by 
no means the only agency involved; the Centers for Disease Control and 
Prevention (CDC), the Food and Drug Administration (FDA), the 
Department of Defense (DoD), the Department of Homeland Security (DHS), 
the Department of Agriculture (USDA), and other governmental 
organizations also play important roles. Coordination among the various 
agencies involved is therefore extremely important. In broad terms, 
Federal medical countermeasures research is coordinated at three 
distinct levels: within NIH, within DHHS, and across the government as 
a whole.
    Within NIH. Although NIAID is responsible for the majority of NIH-
sponsored medical countermeasures research for infectious agents and 
toxins, other NIH Institutes and Centers make significant 
contributions. The focal point for trans-NIH coordination and planning 
of all medical countermeasure research activities in these areas is the 
NIH Biodefense Research Coordinating Committee. I am Chairman of this 
committee, which meets at least quarterly. It is administered by the 
NIAID Office of Biodefense Research, which also serves as the liaison 
office for NIH contacts with other Federal agencies such as DoD and 
DHS.
    Within DHHS. Coordination of medical countermeasures research 
between the CDC, NIH, FDA, and other agencies within DHHS is the 
responsibility of the DHHS Office of Public Health Emergency 
Preparedness (OPHEP). The OPHEP Office of Research and Development 
Coordination holds periodic meetings with all governmental stakeholders 
in the development of medical countermeasures.
    Across Federal Agencies. At the highest level, coordination of 
medical countermeasures research is carried out by the White House, and 
in particular, the Homeland Security Council, the National Security 
Council, and the Office of Science and Technology Policy. The focal 
point for interagency efforts to establish U.S. Government requirements 
and prioritize and coordinate medical countermeasures acquisition 
programs is the Weapons of Mass Destruction Medical Countermeasures 
(WMDMC) Subcommittee (``WMDMC Subcommittee''). This interagency 
subcommittee of the National Science and Technology Council is co-
chaired by DHHS, DHS, and DoD and draws stakeholders from throughout 
the Federal government.
    Although these three levels describe the structure through which 
biodefense research programs are formally coordinated, NIH collaborates 
daily with the other Federal agencies and is party to a large number of 
interagency programs, informal contacts, and communication mechanisms 
that significantly contribute to the efficiency and effectiveness with 
which medical countermeasures research is carried out across the U.S. 
Government. For example, my staff meets regularly with the Defense 
Threat Reduction Agency and the Defense Advanced Research Projects 
Agency, two important entities within the research infrastructure in 
the DOD. NIH biodefense staff also work closely with the research 
community at Fort Detrick and the United States Army Medical Research 
and Materiel Command. Moreover, NIH is a major participant in the 
National Interagency Biodefense Campus now under construction at Fort 
Detrick; once complete, this facility will foster improved coordination 
and synergy in Federal biodefense activities.

    Emerging Engineered and Natural Threats
    Looking toward the future, it is clear that as the power of 
biological science and technology continues to grow it will become 
increasingly possible that we will face an attack with a pathogen that 
has been deliberately engineered for increased virulence. This enhanced 
virulence could take the form of resistance to one of more antibiotic 
or antiviral drugs, increased infectiousness or pathogenicity, or, in 
the somewhat longer term, a new virulent pathogen made by combining 
genes from more than one organism. Ongoing research to counter these 
threats includes the development of new broad spectrum therapies, new 
vaccines with broad cross-reactivity, and immunomodulators to make 
drugs and vaccines more effective.
    Threats arising from deliberate human action are not the only 
dangers we will confront, because naturally occurring infectious 
diseases such as HIV/AIDS, SARS, and West Nile virus emerge or re-
emerge on a regular basis. A current example is the H5N1 avian 
influenza virus, which has killed millions of wild and domestic birds, 
as well as more than 50 people in four countries (Thailand, Vietnam, 
Cambodia, and Indonesia). There have been two likely cases of human-to-
human transmission of the H5N1 virus, and it is possible that other 
such transmissions have occurred recently. It is also possible that the 
H5N1 virus, through genetic mutation or recombination with a human-
adapted influenza virus, could become easily transmissible among 
people. Given the poor condition of public health systems in many 
underdeveloped regions and the speed of modern air travel, the 
consequences of such an event would be severe.
    Although a pandemic alert has not yet been declared, NIAID has 
taken a number of steps to develop and clinically test vaccines against 
H5N1 influenza. In January 2004, researchers at St. Jude Children's 
Research Hospital obtained a clinical isolate of a highly virulent H5N1 
virus and used a technique called reverse genetics to create an H5N1 
vaccine candidate from this strain. NIAID then contracted with Sanofi-
Pasteur and Chiron Corporation to manufacture pilot lots of eight and 
ten thousand vaccine doses, respectively. The inactivated H5N1 vaccines 
will be tested in Phase I and II clinical trials that will assess 
safety and the appropriate vaccine dosage to optimize immunogenicity, 
as well as provide information about how the immune system responds to 
this vaccine. The Sanofi-Pasteur trial, which began on April 4 and is 
fully enrolled, is testing the vaccine in approximately 450 healthy 
adults. Trials of the Chiron-produced vaccines are expected to begin 
later this year.
    In addition to these relatively small pilot lots, DHHS contracted 
with Sanofi-Pasteur to produce two million doses of its H5N1 vaccine, 
in order to ensure that the manufacturing techniques, procedures, and 
conditions that would be used for large-scale production will yield a 
satisfactory product. Moving to large-scale production of the vaccine 
in parallel with clinical testing of pilot lots is an unusual step, and 
an indication of the urgency with which we have determined that H5N1 
vaccine development must be addressed. Waiting for the results of the 
initial clinical trials, which would be the normal procedure, would 
delay our ability to make large quantities of vaccine by at least six 
months. These doses, which have now been manufactured, could be used to 
vaccinate health care workers, researchers, and, if indicated, the 
public in affected areas.
    Antiviral medications are an important counterpart to vaccines as a 
means of controlling influenza outbreaks, both to prevent illness after 
exposure and to treat infection after it occurs. Efforts are underway 
to test and improve antiviral drugs to prevent or treat H5N1 influenza. 
Researchers recently determined that H5N1 viruses are sensitive to 
oseltamivir, a neuraminidase inhibitor that is marketed as Tamiflu and 
is approved for individuals older than one year. DHHS has deposited 
approximately 2.3 million treatment courses of oseltamivir in the SNS, 
to which it is anticipated that more doses will be added. Scientists 
are planning to conduct studies to further characterize the safety 
profile of oseltamivir for very young children; other studies are in 
progress to evaluate novel drug targets, as well as long-acting next-
generation neuraminidase inhibitors. In addition, development and 
testing in animals of a combination antiviral regimen against H5N1 and 
other potential pandemic influenza strains is underway.
    NIAID also is developing vaccines that are potentially protective 
against SARS and West Nile virus. NIAID scientists at the Vaccine 
Research Center have completed enrollment for a Phase I trial of a 
recombinant SARS DNA vaccine, and have initiated a Phase I clinical 
trial of a DNA West Nile virus vaccine.
    In conclusion, it is clear that defense against biological threats, 
whether natural or the result of deliberate human action, will of 
necessity continue to be a high national security priority for the 
foreseeable future. As per the President's Homeland Security 
Presidential Directive 10, ``Biodefense in the 21st Century,'' NIH is 
taking the lead in the construction of a sustainable and comprehensive 
program to develop medical countermeasures for biological threat 
agents. The long institutional experience that NIAID has had with 
infectious disease research allowed us to rapidly take on a greatly 
expanded role in civilian biodefense after the terrorist attacks in the 
fall of 2001, and I am confident that we are making good progress.
    I appreciate this opportunity to appear before you today, and I 
would be pleased to answer any questions that you may have.

    Mr. Linder. Thank you, Dr. Fauci.
    General Schoomaker.

 STATEMENT OF BRIGADIER GENERAL ERIC B. SCHOOMAKER, COMMANDING 
GENERAL, U.S. ARMY MEDICAL RESEARCH AND MATERIEL COMMAND, FORT 
                       DETRICK, MARYLAND

    General Schoomaker. Mr. Chairman and members of the 
committee, thank you for this opportunity to discuss the role 
of the United States Army Medical Research and Materiel 
Command, or MRMC, in the implementation of the National 
Biodefense Strategy, focused around our interagency 
partnerships.
    I am the commanding general of the MRMC and Fort Detrick. I 
am responsible for delivering the best medical solutions in the 
form of both expertise and products, such as vaccines and 
therapeutic agents to enhance, protect, and treat the 
warfighter on point for the Nation. Since the 2001 attacks on 
the United States, this mission has expanded to include 
providing assistance to other Federal partners in protecting 
the Nation.
    In my short time in this position, I have been very 
impressed with the steps taken by our talented personnel and 
our interagency partners represented here by this panel to 
implement the National Biodefense Strategy and congressional 
guidance. We are clearly on the road toward a vigorous and 
already productive interagency partnership that will ensure we 
meet the biomedical research and developmental goals of this 
strategy.
    Army and DOD researchers have led the medical biodefense 
research and development for over 35 years. We have gifted 
people with unique expertise, facilities and capabilities and a 
proven track record. Laboratories within the MRMC are leaders 
in the biodefense effort particularly the United States Army 
Medical Research Institute for Infectious Diseases, or 
USAMRIID, which is located at Fort Detrick. Many of the 
Nation's biodefense experts work at, or have learned their 
skills from, USAMRIID. Many know USAMRIID as the home of the 
largest biosafety level 4 research capability and as the 
organization that has been repeatedly called upon and has 
responded to disease outbreaks such as the anthrax contaminated 
letters in 2001. A new USAMRIID facility is an essential 
element of implementing the National Biodefense Strategy.
    The interagency partnership which I have been discussing, 
is embodied by the National Interagency Biodefense Campus, or 
NIBC, being planned at Fort Detrick, Maryland. Our challenge at 
Fort Detrick is to become the host of the NIBC, comprised of 
biodefense laboratories of the United States Army, the National 
Institutes of Allergy and Infectious Disease, or NIAID, the 
Department of Health and Human Services, or HHS, the National 
Institutes of Health, the Department of Homeland Security, the 
Department of Agriculture, and, in collaboration with the 
Centers for Disease Control and Prevention, or CDC, and others. 
Each NIBC partner will implement part of its agency's overall 
biodefense program. Collectively, the laboratories and partners 
will collaborate on developing a comprehensive understanding of 
biologic agent characteristics, elucidating disease processes, 
and developing products to reduce risks to human health and 
agricultural productivity. Additionally, the Frederick Campus 
of the National Cancer Institute of the HHS, or the NCI, which 
is already located on Fort Detrick, will collaborate with and 
provide biotechnology support for the NIBC partners. In 
summary, we are ensuring the congressionally directed 
laboratory colocation will become a vibrant interagency 
partnership to enhance the biodefense of the Nation.
    While DOD must continue to prioritize our projects and 
dedicate our resources to protect and treat the warrior on 
point for the Nation, we see the NIBC as a unique opportunity. 
You have heard some of these mentioned already. We can develop 
a more effective military program by leveraging complementary 
efforts of multiple agencies to defend our military and our 
homeland against biowarfare and bioterrism. We anticipate that 
the colocation will compress the discovery cycle to accelerate 
the development and the approval of new medical 
countermeasures.
    Together, the interagency partners are moving forward to 
ensure that the NIBC follows the National Biodefense Strategy 
by coupling our complementary efforts. We have already formed 
coordinating committees. We have already looked into our 
complementary capacities, and using the pillars of the 
President's strategy, and we are harnessing our capabilities on 
an interagency basis so that we are not duplicative. Our mantra 
is ``duplication by design and not by default.''
    Planning for the future is really already informing the 
present. Research collaborations between the Federal agencies 
and the private industry have already begun. For example, these 
three agencies have contributed to research and development of 
this new generation of U.S. anthrax vaccine.
    We feel very good about this collaboration. We are not 
waiting for buildings; the interagency cooperation has begun 
already. We feel that this campus will also prepare us the 
bench of scientists and the critical mass of intellectual power 
that we require for the future to get those unanticipated 
agents there.
    Mr. Chairman, this concludes my remarks. And I am pleased 
to answer any questions you might have.
    [The statement of General Schoomaker follows:]

       Prepared Statement of Brigadier General Eric B. Schoomaker

    Mr. Chairman and members of the committee, thank you for this 
opportunity to discuss the role of the U.S. Army Medical Research and 
Materiel Command, or MRMC, in the implementation of the National 
Biodefense Strategy focused around our interagency partnerships.
    I am the Commanding General of the MRMC and Fort Detrick. I am 
responsible for delivering the best medical solutions--in the form of 
both expertise and products, such as vaccines and therapeutic agents--
to enhance, protect, and treat the warfighter on point for the Nation. 
This responsibility includes protection against, and treatment for, 
intentional or natural biological threats. Since the 2001 attacks on 
the U.S., this mission has expanded to include providing assistance to 
the other Federal partners in the protection of the Nation.
    In my short time in this position, I have been very impressed with 
the steps our talented personnel and our interagency partners have 
taken to implement the National Biodefense Strategy and Congressional 
guidance. I am proud to describe a partnership that goes beyond the 
Army and the Department of Defense, as we are clearly on the road 
toward a vigorous and already productive interagency partnership that 
will ensure we meet the biomedical research and development goals of 
the Strategy.
    Army and DoD researchers have led medical biodefense research and 
development for over 35 years. We have gifted people with unique 
expertise, facilities, and capabilities--and a proven track record. 
Laboratories within the MRMC are leaders in the biodefense effort, 
particularly the U.S. Army Medical Research Institute of Infectious 
Diseases, or USAMRIID, which is located at Fort Detrick. Many of the 
Nation/s biodefense experts are at, or learned their skills from, 
USAMRIID. Many know USAMRIID as the home of largest biosafety level 4 
research capability and as the organization that has repeatedly 
responded to disease outbreaks such as the anthrax-contaminated letters 
in 2001. A new USAMRIID facility is an essential element of 
implementing the National Biodefense Strategy.
    The interagency partnership, which I have been discussing, can be 
embodied by the National Interagency Biodefense Campus, or NIBC, being 
planned for Fort Detrick, Maryland. Our challenge at Fort Detrick is to 
become the host of the NIBC comprised of biodefense laboratories of the 
the Army; the National Institute of Allergy and Infectious Diseases, or 
NIAID, of the Department of Health and Human Services (HHS) National 
Institutes of Health; the Department of Homeland Security; the 
Department of Agriculture; and in collaboration with the HHS Centers 
for Disease Control and Prevention, or CDC; and others.''
    Each NIBC partner will implement part of its agency's overall 
biodefense program. Collectively, the laboratories and partners will 
collaborate on developing a comprehensive understanding of biological 
agent characteristics, elucidating disease processes, and developing 
products to reduce risks to human health and agricultural productivity. 
Additionally, the Frederick Campus of the HHS National Cancer 
Institute, or the NCI, already located on Fort Detrick, will 
collaborate with and provide biotechnology support for the NIBC 
partners.
    Using Congressional guidance, we took a proactive role and invited 
partner Federal agencies mentioned earlier to join us in an interagency 
campus that would build upon the foundation already present at Fort 
Detrick. We are providing Army land and Army infrastructure, as well as 
facilitating the process of interagency leadership. In sum, we are 
ensuring the Congressionally-directed laboratory collocation will 
become a vibrant interagency partnership that will enhance the 
biodefense of the Nation.
    While DoD must continue to prioritize our projects and dedicate our 
resources to protect and treat the warrior on point for the Nation, we 
see the NIBC as a unique opportunity. We can develop a more effective 
military program by leveraging complementary efforts of multiple 
agencies to defend our military and our homeland against biowarfare and 
bioterrorism. We anticipate that collocation will compress the 
discovery cycle to accelerate the development and approval of new 
medical countermeasures.
    Together, the interagency partners are moving forward to ensure the 
NIBC follows the National Biodefense Strategy by coupling our 
complementary efforts. We have formed coordinating committees of 
scientists and others to ensure we address the four pillars of the 
Strategy (Threat Awareness, Prevention and Protection, Surveillance and 
Detection, and Response and Recovery). While harnessing our interagency 
capabilities we are avoiding unnecessary duplication and economizing 
efforts. Our mantra is ``duplication by design and not by default.''
    Planning for the future is already informing the present. Research 
collaborations with Federal agencies and private industry have already 
begun. For example, three agencies have contributed to the research and 
development of the next generation U.S. anthrax vaccine. The technology 
was developed at USAMRIID, the initial production was accomplished at 
the NCI, and the final manufacture, licensure, and commercialization is 
being accomplished by the HHS NIAID and the HHS Office of the Assistant 
Secretary for Public Health Emergency Preparedness via contract with 
VaxGen, Inc. through Project BioShield. This serves as a model option, 
currently being followed for other countermeasures, for successful 
development of solutions for national defense.
    The NIBC will enhance our responsiveness to natural public health 
threats as well as intentional bioterrorism; it is important to note 
that these initially may be indistinguishable. For example, interagency 
partnerships played a key role in developing diagnostic systems and 
evaluating antiviral drugs for Severe Acute Respiratory Syndrome, or 
SARS, during an outbreak in several countries. CDC and USAMRIID 
developed tests for this newly emerging disease entity. Additionally, 
NIAID and USAMRIID screened over one hundred thousand compounds against 
the SARS-associated virus and one promising candidate has entered into 
clinical trials sponsored by Intermune, a commercial partner.
    You can see that we are not waiting for buildings; in fact, 
collaboration existed among interagency partners before the NIBC 
concept was developed and additional partnership activities have begun 
and are further planned. These and other examples demonstrate that we 
know we are more effective working together than alone.
    One final key aspect of the NIBC is development of the bench by 
having a critical mass of personnel in partnership with the community 
of Frederick, MD, and academic and business partners. Through these 
measures, we will have the opportunity to improve the intellectual 
pipeline focused on the Nation's defense against bioterrorism.
    We're making significant progress every day toward realizing the 
vision of the National Biodefense Strategy. Fort Detrick and the NIBC 
will be a collaborative center of biodefense medical research and 
development excellence for our Nation. All partners have established 
good working relationships and the Frederick community is extremely 
supportive.
    We are excited to be part of this historic partnership. I want to 
thank Congress for its material support of the non-DoD NIBC partners 
and for its recognition of the MRMC and USAMRIID as pivotal elements of 
this interagency partnership.
    Mr. Chairman, this concludes my remarks, and I will be pleased to 
answer your questions.

    Mr. Linder. Thank you, Dr. Schoomaker.
    Dr. Vitko.

   STATEMENT OF JOHN VITKO, JR., Ph.D., DIRECTOR, BIOLOGICAL 
 COUNTERMEASURE PORTFOLIO, SCIENCE AND TECHNOLOGY DIRECTORATE, 
                DEPARTMENT OF HOMELAND SECURITY

    Mr. Vitko. Good afternoon, Chairman Linder, and Ranking 
Member Langevin and distinguished members of the committee. I 
am pleased to appear before you today to discuss the role of 
the Department of Homeland Security in implementing the 
National Biodefense Strategy. This strategy outlines four 
essential pillars: Threat awareness, prevention and protection; 
surveillance and detection; response and recovery.
    DHS plays a major role in each of these pillars, leading 
the efforts in risk and net assessments, critical 
infrastructure protection, coordination of attack warning, 
forensics analysis and support attribution, response planning, 
and coordinated risk communications. In each of these areas, we 
work closely with our partners such as HHS, DOD, USDA, EPA, 
Department of Justice, and the intelligence community.
    Today I would like to focus on the activities within the 
Science and Technology Directorate, S&T. But, before doing so, 
it is important to note that other DHS directorates also have 
major roles in implementing the National Biodefense Strategy.
    The emergency preparedness and response directorate and its 
partners have developed a national response plan and a national 
incident management system to guide coordinated Federal, State, 
local and international response to biological attack. The 
information analysis and infrastructure protection directorate 
coordinates the national infrastructure protection plan. And 
the public information office coordinates comprehensive risk 
communication strategies.
    Now I will focus on the role of S&T biodefense activities 
which I direct in implementing the strategy.
    Under threat awareness, the national strategy charges DHS 
with the lead responsibility for conducting threat assessments 
to help prioritize the Nation's biodefense activities. To this 
end, S&T is conducting threat assessments and material threat 
determinations to help prioritize BioShield acquisitions and 
inform the associated requirements. To date, the secretary of 
DHS has issued formal determinations for anthrax, smallpox, 
botulinum toxin, and for radiological and nuclear devices. 
Three more assessments are in final review, and depending on 
their outcomes may result in additional material threat 
determinations.
    Second, we are in the midst of a broader set of forma risk 
assessments covering 29 agents with the results to be available 
in January 2006.
    Third, we are conducting laboratory experiments to reduce 
the uncertainty in some of the key parameters that affect these 
assessments. These experiments are being conducted in an 
interim national biodefense analysis and countermeasure center, 
NBACC, pending the completion of the new facility on the Fort 
Detrick campus in 2008 as part of the NBIC that General 
Schoomaker just talked about. DHS has also worked closely with 
HHS in their lead to develop a strategy for addressing 
engineered threats.
    In the area of prevention and protection, S&T's main role 
has been working on agro defense and, in particular, in the 
area of foreign animal diseases. In this, we work very closely 
with USDA. S&T owns and operates the Plum Island Animal Disease 
Center. Working with USDA, we have developed and are 
implementing a joint strategy for foreign animal diseases to 
expedite the transition of new vaccines and immunomodulators to 
National Veterinary Stockpile and of new validated diagnostics 
to the National Animal Health Laboratory Network.
    Recognizing the Plum Island facility is more than 50 years 
old, we have funded the conceptual design of the next 
generation facility, the National Bio and Agradefense Facility. 
S&T has also established two university centers of excellence 
in agricultural and food protection.
    In the area of surveillance and detection, national 
strategy calls for creating a national bioawareness system to 
permit the recognition of attack at the earliest possible 
moment. To that end, S&T has partnered with EPA and CDC to 
deploy BioWatch, the Nation's first bio-aerosol monitoring 
system. This first-generation system has been operating for 
more than 2 years and has performed more than 1.5 million 
assays to date without a false positive. We are currently 
deploying a second-generation system which greatly increases 
the number of air samplers and the supporting analysis in the 
top threat cities. And we are in the midst of developing the 
next-generation detection system which will automatically 
analyze the air samples onsite rather than taking them to an 
off-site laboratory, thereby greatly reducing the cost and 
making biologics accessible to even more communities.
    We have also taken several major actions to coordinate 
biodetection activities amongst the various departments. These 
include an interagency memorandum of understanding on 
coordinated monitoring of biological threat agents, a pilot 
demonstration of joint civilian and military concepts of 
operation for early detection and characterization of 
biological events, and a preliminary approach for making 
versions of the high sensitivity, high specificity assays 
developed by the United States Government available to the 
private sector for commercial development with suitable testing 
and quality control.
    Biodefense for the 21st century also explicitly designates 
NBACC's, National Bioforensics Analysis Center, NBFAC, as the 
Nation's lead facility for technical forensic analysis to 
support attribution. Pending the completion of the new NBACC 
facility in fiscal year 2008, NBFAC has established interim 
capabilities at USAMRIID and is already conducting extensive 
casework supporting FBI investigations of biocrimes or 
bioterrorism.
    In summary, DHS has been working closely with its 
interagency partners in fulfilling the important roles assigned 
to it in the National Biodefense Strategy and has already made 
major contributions to defending this Nation against attacks 
with biological agents.
    Mr. Chairman, Ranking Member Langevin, and members of the 
committee, I thank you for the opportunity to appear before 
you, and I will be happy to answer any questions you may have.
    [The statement of Mr. 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 Department of Homeland Security 
(DHS) in the implementation strategy and progress in executing the 
major provisions of Biodefense for the 21st Century.
    Biological threats can take many forms and be distributed in many 
ways. Aerosolized anthrax, smallpox, foot and mouth disease, and bulk 
food contamination are among the threats that can have high 
consequences for humans and agriculture. Recognizing the natural 
availability of biological agents, their ease of production and use, 
infrastructure vulnerabilities, and need for a coordinated consequence 
management plan for a bioterrorist attack response, President Bush 
instructed Federal departments and agencies to review their efforts and 
find better ways to secure America from bioattacks.
    In April 2004, this review culminated in approval of a joint 
strategy entitled Biodefense for the 21st Century. This strategy 
provides a comprehensive framework for our nation's biodefense. This 
directive builds upon past accomplishments, specifies agency roles and 
responsibilities, and integrates the programs and efforts of various 
communities--national security, medical, public health, intelligence, 
diplomatic, agricultural and law enforcement--into a sustained and 
focused effort against biological weapons threats.
    The Department of Homeland Security (DHS) and the Science and 
Technology (S&T) Directorate have major responsibilities in this 
integrated national effort. In particular, I want to highlight our 
progress in implementing this comprehensive strategy and the 
effectiveness of our interagency collaborations with our key Federal 
partners, including those represented here today.

    Mission and Objectives:
    The presidential directive Biodefense for the 21st Century outlines 
four essential pillars of the nation's biodefense program and defines 
the responsibilities of the various Federal departments and agencies 
with respect to implementing this strategy. The four pillars with the 
designated lead agencies shown in parentheses are:
         Threat Awareness, which includes biological weapons-
        related intelligence (intelligence community), risk and net 
        assessments (DHS), and anticipation of future threats (HHS).
         Prevention and Protection, which includes proactive 
        prevention (Department of State, Department of Defense, 
        Department of Justice and the Intelligence Community) and 
        critical infrastructure protection (DHS).
         Surveillance and Detection, which includes attack 
        warning (DHS) and attribution (DHS analysis in support of lead 
        agency).
         Response and Recovery, which includes response 
        planning (DHS), mass casualty care (HHS), risk communication 
        (DHS), medical countermeasures (HHS), and decontamination 
        (EPA).

    MULTIPLE DHS ORGANIZATIONAL ELEMENTS HAVE MAJOR ROLES IN 
IMPLEMENTING THE NATIONAL BIODEFENSE STRATEGY
    Before specifically addressing the activities of Science and 
Technology Directorate, it is important to note that several other DHS 
organizational elements have major roles and responsibilities in 
implementing the national biodefense strategy.
    The Emergency Preparedness and Response Directorate (EPR) has the 
lead responsibility for working with other appropriate Federal 
departments and agencies, to develop comprehensive plans that provide 
for seamless, coordinated Federal, state, local, and international 
responses to a biological attack. To this end, EPR and its partners 
have developed the National Response Plan (NRP) and the National 
Incident Management System (NIMS). The NRP includes Emergency Support 
Functions (ESFs) to provide Federal resources during a response, 
including those for public health and medical services (ESF-8, HHS 
lead) and for agriculture and natural resources (ESF-11, USDA lead). 
EPR also operates the National Medical Disaster System (NMDS) and works 
closely with HHS in their lead for mass casualty care.
    The Office of Domestic Preparedness/State and Local Government 
Coordination and Preparedness operates the Metropolitan Medical 
Response System (MMRS).
    The Information Analysis and Infrastructure Protection (IAIP) 
Directorate has the lead for critical infrastructure protection 
(including agriculture and food); the S&T Directorate supports IAIP in 
this role. IAIP coordinates the National Infrastructure Protection Plan 
(NIPP) which includes shielding critical components of the nation's 
infrastructure and development of pre-event mitigation strategies. IAIP 
has the lead DHS role in outreach to the private sector through the 
interfaces provided by the various Sector Coordinating Councils and the 
Government Coordinating Councils. IAIP intelligence analysts also work 
closely with their counterparts in the National Counter-Terrorism 
Center (NCTC) the FBI, CIA and DIA in assessing the intent of the 
enemy, their capabilities, potential scenarios, and attack vectors. 
Working with counterterrorist experts in the Community, they develop 
link charts on potential associates here in the United States of 
operatives abroad who may have received training in weapons of mass 
destruction (WMD) capabilities or have knowledge of WMD programs.
    The Public Information Office (PIO) works with other appropriate 
Federal departments and agencies to develop ``comprehensive coordinated 
risk communication strategies to facilitate emergency preparedness for 
biological weapons attacks. This includes travel and citizen 
advisories, international coordination and communication, and response 
and recovery communications in the event of a large-scale biological 
attack.''

    S&T DIRECTORATE ROLES AND ACCOMPLISHMENTS
    Within the S&T Directorate, the responsibilities for implementing 
the National Biodefense Strategy fall within Biological Countermeasures 
Portfolio, which I direct. The mission of this Portfolio is to provide 
the understanding, technologies, and systems needed to protect against 
biological attacks on the nation's population, agriculture, or 
infrastructure. Within this mission, the S&T Directorate has the lead 
role for decision support tools, risk assessments and support to 
intelligence, early detection and attack analysis, and bioforensics 
analysis.
    DHS S&T also supports our partnering departments and agencies with 
their leads in other key areas of an integrated biodefense: the 
Department of Health and Human Services (HHS) on medical 
countermeasures and mass casualty response; the Department of Defense 
(DoD) on broad range of homeland security/homeland defense issues; the 
U.S. Department of Agriculture (USDA) on agriculture biosecurity; USDA 
and HHS on food defense; the HHS and Department of Veterans' Affairs 
(VA) on maintaining the Strategic National Stockpile and other 
pharmaceutical caches (antidotes, vaccines and ventilators); the 
Environmental Protection Agency (EPA) on response and recovery, 
including water safety; the Department of Justice on bioterrorism 
investigations; and the Intelligence Community on threat warnings.
    Today I would like to focus on the technical progress of the 
Biological Countermeasures Portfolio as it relates to the pillars of 
defense outlined in Biodefense for the 21st Century.

    THREAT AWARENESS
    Under Biodefense for the 21st Century, DHS has the lead 
responsibility for conducting threats assessments to guide 
prioritization of the Nation's on-going investments in biodefense-
related research, development, planning, and preparedness. To this end, 
the S&T Directorate is leading three major threat assessment 
activities:
         Material Threat Assessments and Determinations to 
        support Project BioShield development of medical 
        countermeasures;
         Formal periodic risk assessments of a broad range of 
        biothreat agents to guide the broader range of bio-defense 
        investments; and
         Laboratory based characterization of the threats to 
        close key gaps in informing the above risk assessments.
    The first of these activities is being led out of the S&T 
Directorate's Biodefense Knowledge Center and the latter two out of the 
BioThreat Characterization Center (BTCC) of the National Biodefense 
Countermeasures and Analysis Center (NBACC).
    In addition to these lead roles, DHS has worked closely with HHS, 
in their lead role, to develop a strategy for addressing engineered 
threats.

    Material Threat Assessments (MTAs) and Material Threat 
Determinations for BioShield
    The Project BioShield Act of 2004 charges the Secretary of Homeland 
Security with the responsibility to determine which biological, 
chemical, radiological or nuclear threats constitute a Material Threat 
to our Nation's security. To fulfill this responsibility, the S&T 
Directorate , in partnership with the IAIP Protection Directorate, has 
been conducting formal threat assessments of the agents of greatest 
concern to establish plausible high consequence scenarios. These 
assessments combine intelligence information with technical assessments 
of the feasibility of a terrorist to produce and disseminate the agent 
to provide an indication of the number of exposed individuals, the 
geographical extent of the exposure, and other collateral effects. If 
these consequences are of such a magnitude to be of significant concern 
to our national security or public health, the Secretary of DHS then 
issues a formal Material Threat Determination to the Secretary of HHS, 
which initiates the BioShield process. Subsequently, HHS, assisted by 
the interagency Weapons of Mass Destruction Medical Countermeasures 
subcommittee, determines the need for, and requirements of, any new 
medical countermeasures.
    To date, the Secretary of DHS has issued Material Threat 
Determinations for anthrax, smallpox, botulinum toxin and radiological/
nuclear devices. Assessments are nearly complete for plague, tularemia, 
and chemical nerve agents, and an assessment of viral hemorrhagic 
fevers will be initiated in August. Based on the outcomes of these 
assessments, the Secretary of DHS may issue additional Material Threat 
Determinations.

    Risk Assessments across a Broader Range of Biological Threats
    As part of its responsibility in the President's National 
Biodefense Strategy, DHS is required to conduct periodic, formal risk 
assessments of a much broader set of biological agents to help 
prioritize the nation's ongoing biodefense activities. These risk 
assessments provide a systematic evaluation of the development and 
deployment of a broad range of biological threats, the vulnerability of 
different portions of our society to those threats, and the resulting 
consequences of any such attacks.
    The first such formal risk assessment is due in January of 2006, 
with subsequent assessments due every two years. The scope, process, 
and timescale for this first assessment have been presented to and 
agreed to by the interagency Biodefense Policy Coordinating Committee 
co-chaired by the Homeland Security Council and the National Security 
Council. This risk assessment is addressing 29 biological agents and is 
being conducted in partnership with the Intelligence Community, HHS, 
DoD, USDA, EPA, the IAIP Directorate and others. Two advisory boards, 
one a Government Stakeholders Advisory Board and the other an 
Independent Risk Assessment Expert Review Board (academia, industry, 
and government), have been established to provide input and advice.

    A Strategy for Addressing Emerging Threats
    Much of the biodefense efforts to date have focused on protecting 
against attacks with bioterrorism agents that can be (or used to be) 
found in nature. However, rapid advances in biotechnology demand that 
we also consider the possibility and impact of emerging or engineered 
agents, for example, modifications to organisms that increase their 
resistance to medical countermeasure or make them more difficult to 
detect. The President's Biodefense for the 21st Century assigns HHS the 
lead in anticipating such future threats. The S&T Directorate is 
partnering with HHS and others in formulating and implementing a 
strategy for anticipating and responding to such threats.
    Based on intelligence information, available literature and expert 
judgment, we have developed an informed estimate of the types of 
emerging threats that might be within the ability of a terrorist 
organization to develop over the near (1-3 years), mid (4-10 years), 
and longer-terms (10 yrs). In this analysis, four elements stand out as 
essential to an effective defense against emerging threats:
         Threat, vulnerability and risk assessments to 
        prioritize these threats in terms of the difficulty of their 
        development and deployment, as well as their potential 
        consequences;
         Surveillance and detection capabilities to rapidly 
        detect and characterize engineered agents in environmental and 
        clinical samples so as to provide timely guidance in the 
        selection of the appropriate medical countermeasure;
         An expanded range of safe and effective medical 
        countermeasures and an infrastructure to support rapid 
        research, development, test, and evaluation (RDT&E) of new 
        medical countermeasures; and
         Integrated concepts of operation (CONOPS) for the 
        identification and response to emerging threats.

    Scientific research to better inform these threat and risk 
assessments
    The threat and risk assessments described above are performed with 
the best available information. However, there are large uncertainties, 
sometimes factors of ten to a hundred, in some of the key parameters 
and hence in the associated risks. One of the major functions of the 
threat and risk assessments is to identify these critical knowledge 
gaps, which can differ for different threat scenarios--in one case it 
may be the minimum amount of agent needed to infect a person; in 
another case it may be the time that such an agent remains viable 
(capable of causing an infection) in the air, food or water; and in a 
third it may be the effect of food processing or water treatment on the 
agent's viability. Conducting the laboratory experiments to close the 
critical knowledge gaps is a primary function of DHS's National 
Biodefense Analysis and Countermeasures Center (NBACC).
    Congress has appropriated a total of $128M for design and 
construction of NBACC with the necessary biocontainment laboratory 
space and support infrastructure to conduct these and other 
experiments. NBACC will be built on the National Interagency Biodefense 
Campus (NIBC) at Ft. Detrick, MD, in close physical proximity to the 
DoD's United States Army Medical Research Institute of Infectious 
Diseases (USAMRIID), the HHS National Institutes of Health's's 
Integrated Research Facility and the USDA's Foreign Disease-Weed 
Science Research Unit. NBACC is also collaborating with the HHS Centers 
for Disease Control and Prevention, a new member of the NIBC, to 
further address the critical knowledge gaps. The Record of Decision for 
NBACC's Final Environmental Impact Statement was signed in January 
2005. Design of the facility began in March 2005, with construction 
scheduled to begin in FY 2006 and be complete by the fourth quarter of 
FY 2008.
    Currently, interim capabilities for both NBACC's biological threat 
awareness and bioforensic analysis functions have been established with 
other government and private laboratories to allow vital work in these 
areas to occur during the NBACC facility's construction

    PREVENTION AND PROTECTION: CRITICAL INFRASTRUCTURE PROTECTION: 
AGRO-DEFENSE
    Biodefense for the 21st Century tasks DHS with leading efforts to 
protect critical infrastructures from biological attack. HSPD-9 further 
details these responsibilities for protecting agriculture and food. 
Significant S&T Directorate roles include:
         Acceleration and expansion of the development of 
        current and new veterinary countermeasures;
         Developing with USDA a plan to provide facilities for 
        research and diagnostic capabilities for foreign animal and 
        zoonotic diseases; and
         Establishing new university centers of excellence for 
        agriculture and food security.
    In 2003, the S&T Directorate and USDA (Agricultural Research 
Service [ARS], and Animal and Plant Health Inspection Service [APHIS]) 
began developing a joint strategy for foreign animal disease. One of 
the first goals of the strategy is to develop veterinary 
countermeasures for foot and mouth disease. Following the process laid 
out in the strategy, ARS has the lead for basic research and early 
development of vaccines and immunomodulators (antivirals). Potential 
candidates are then transitioned to DHS for continued development with 
industry. Once appropriate products are developed, APHIS supplies them 
to the National Veterinary Stockpile. Interagency coordinating meetings 
were held as recently as May 2005 to review progress on the joint 
strategy.
    As part of the integrated biodefense complex, the S&T Directorate 
operates the Plum Island Animal Disease Center (PIADC) and two Homeland 
Security (HS) Centers of Excellence in agricultural security described 
below.

    Plum Island Animal Disease Center
    PIADC is a critical national asset in the strategy for addressing 
foreign animal diseases. This strategy includes programs on:
         Net assessment of the foreign animal disease threat;
         Vaccines and therapeutics:
                 Improved current vaccines (onset of immunity, 
                adjuvants);
                 Development of next-generation vaccines and 
                immunomodulators; and
                 Transition of promising candidates to industry 
                partners for full product development.
         Assays and diagnostics:
                 National and international validation;
                 Enhanced diagnostics capability and surge 
                capacity; and
                 A new bioforensics capability.
    The overall goal of this strategy is to expedite the transition of 
new vaccines and immunomodulators to the USDA National Veterinary 
Stockpile and of new validated diagnostics to the USDA National Animal 
Health Laboratory Network (NAHLN), as well as increasing surge capacity 
at critical nodes of the response infrastructure.
    In addition to these research and diagnostics programs, the S&T 
Directorate has responsibility for the maintenance and operations of 
the PIADC facilities, including necessary upgrades and enhancements of 
facilities and security.
    To facilitate overall coordination of these programs at PIADC, a 
Board of Directors has been established, chaired by the S&T Directorate 
and including the administrators of both ARS and APHIS. In addition, 
the Office of Science and Technology Policy's National Science and 
Technology Council recently established a new Subcommittee on Foreign 
Animal Disease Threats which is co-chaired by USDA and the S&T 
Directorate and provides a valuable new interagency forum for 
cooperation.

    NATIONAL BIO AND AGRODEFENSE FACILITY
    PIADC is a unique and critical facility for the nation's foreign 
animal disease defense and celebrated its 50th anniversary in 2004. 
Thus, the facility is now well beyond its originally planned life span, 
and is in need of recapitalization.
    In FY 2005 the S&T Directorate is funding a conceptual design study 
for a next-generation facility, the National Bio and Agrodefense 
Facility (NBAF). The goal of this study is to determine the 
programmatic drivers for the necessary size and scope of the facility 
and the research and development to be conducted there. Three major 
programmatic themes are being considered:
         The historical PIADC mission for foreign animal 
        disease research in livestock, with needs anticipated over the 
        lifetime of the new facility (approximately 40 years);
         The study of zoonotic diseases, including associated 
        requirements for specific biosafety levels of containment; and
         Testing and evaluation required for approval of 
        medical countermeasures by the Food and Drug Administration 
        (FDA) in HHS.
    DHS is working closely with its interagency partners throughout 
this planning process, including USDA and HHS.
    The proposed FY 2006 budget for DHS includes $23M for the 
architectural and engineering design and pre-construction costs of the 
NBAF.

    University Centers of Excellence
    In addition, the S&T Directorate has established two University 
Centers of Excellence explicitly focused on agricultural and food 
protection. Texas A&M University and its partners from the University 
of Texas Medical Branch, University of California at Davis, and the 
University of Southern California have formed the National Center for 
Foreign Animal and Zoonotic Disease Defense. They are working closely 
with partners in academia, industry, and government to address 
potential threats to animal agriculture, including Foot and Mouth 
Disease (FMD), Rift Valley fever, avian influenza, and brucellosis. The 
University of Minnesota and its partners, Michigan State University, 
University of Wisconsin at Madison, North Dakota State University, 
Georgia Institute of Technology, and the University of Tennessee at 
Knoxville have formed the National Center for Food Protection and 
Defense. They are addressing food issues related to post-harvest food 
protection, including developing a prototype food event modeling 
system, new risk communication approaches to minimize the potential 
impact of food contamination events, and realistic decontamination 
scenarios involving surrogate agents and food matrices.

    SURVEILLANCE AND DETECTION: ATTACK WARNING
    Biodefense for the 21st Century calls for ``creating a national 
bioawareness system (that) will permit the recognition of a biological 
attack at the earliest possible moment and permit initiation of a 
robust response to prevent unnecessary loss of life, economic losses, 
and social disruption.'' Some of the key S&T Directorate activities in 
support of this are:
         Development and upgrading of a BioWatch, an urban 
        bioaerosol monitoring system currently operating in more than 
        30 cities;
         Coordination of interagency biodetection activities; 
        and
         Design of the National Biosurveillance Integration 
        System (NBIS).

    BioWatch
    In early 2003, DHS, in partnership with the EPA and CDC, deployed 
the BioWatch environmental monitoring system to protect our nation's 
cities from the threat and ramifications of a bioterrorist attack This 
first generation system (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 (PCR) analysis. Results are available within 12 hours of filter 
retrieval. This system has been operating for more than two years and 
has performed greater than 1.5 million assays without a false positive.
    We are now in the midst of deploying a second generation system 
(Gen 2 BioWatch), which increases the number of collectors in the top 
ten or so threat cities two to four-fold thereby decreasing the minimum 
size attack that can be detected and increasing the probability of 
detection.
    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 and hence 
limit both the number of collectors deployed and the frequency with 
which filters are retrieved. To overcome these limitations advanced 
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 allow much more frequent sample analysis and address an 
expanded range of agents. 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.
    We are also developing a Biological Warning and Incident 
Characterization (BWIC) System to assist the 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 data (e.g. from CDC's BioSense 
system) to provide an improved understanding about the possible origin 
and extent of the release and some estimate of its possible impact. 
BWIC is currently being piloted in in two cities, and upon completion 
of the pilots will begin a phased deployment to other BioWatch cities.

    Coordination of interagency bio-monitoring and biodetection 
activities
    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 DoD has initiated its Installation 
Protection Program Guardian 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 is a DHS funded, DoD executed program to pilot an integrated 
civilian and military concept of operations for the early detection and 
characterization of biological events. The pilot is currently taking 
place in San Diego, CA, and will be completed this fiscal year. It will 
provide common (or similar) architectures, operational protocols and 
communication processes to link existing/projected civilian and 
military biological detection systems.
    Bio-monitoring 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. The MOU calls for a written plan for coordinated air 
monitoring; protocols and timelines for shared prompt notification; 
determining the ``equivalency'' of biothreat agent testing performed by 
the participating agencies; and a joint technology roadmap to better 
leverage Federal investments. In addition the MOU also contains the 
initial steps in extending this approach to other biodetection 
measurements. This MOU seeks to address 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: In coordination with CDC and DoD, 
we are formulating 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. This approach will be piloted in FY 2006.

    Development of the National Biosurveillance Integration System 
(NBIS)
    There are many other biosurveillance activities being undertaken by 
various Federal Departments and agencies. For example, CDC is 
developing an electronic medical surveillance system (BioSense) to look 
for early medical indicators of a possible biological attack, and USDA 
and HHS are developing the laboratory network for detecting and 
responding to possible food contamination. It is important that the 
information from all these sector specific biosurveillance systems be 
brought together to form a comprehensive biosurveillance situation 
awareness or common operating picture. To that end, the S&T Directorate 
has worked with the various Federal Departments and with industry to 
design the National Biosurveillance Integration System (NBIS). NBIS 
will integrate information on the state of health of people, animals 
and plants with bio-monitoring of air and water, with results from 
regulatory testing of food, and with real-time threat information so as 
to provide the earliest possible detection and characterization of a 
possible bio-attack. The initial design was completed in early FY 2005 
and has been transferred to the IAIP Directorate for implementation.

    SURVEILLANCE AND DETECTION: ATTRIBUTION
    Biodefense for the 21st Century specifically names the National 
Bioforensics Analysis Center (NBFAC) of the National Biodefense 
Analysis and Countermeasures Center (NBACC) as the lead Federal 
facility to conduct and facilitate the technical forensic analysis and 
interpretation of materials recovered following a biological attack in 
support of the appropriate lead Federal agency. As noted above, a new 
NBACC facility will be constructed on the National Interagency 
Biodefense Campus (NIBC) at Ft. Detrick, MD. Pending completion of that 
facility in FY 2008, an interim NBFAC capability has been established 
in leased biocontainment space at USAMRIID also located at Ft. Detrick. 
This leased space was totally renovated to provide a contamination-free 
environment for ultra high sensitivity forensic work. In a short span 
of only 12 months, NBFAC has become operational and is now conducting 
casework supporting on-going FBI investigations of biocrimes or acts of 
bioterrorism. To date, NBFAC is already processing over a hundred 
samples per month. All evidence receipt, accessioning and processing 
are being conducted in secure, contamination free, biocontainment space 
within the interim NBFAC laboratory. This is a capability that was non-
existent at the time of the anthrax attacks in the fall 2001.
    To further bolster the admissibility and validity of biological 
evidence analytical results used in court proceedings, NBFAC will 
obtain the International Organization of Standardization (ISO) 17025 
certification as a reference analytical laboratory in 2005-06. To meet 
stringent ISO certification requirements, NBFAC has established a 
stand-alone Safety and Biosurety Program, Quality/Accreditation 
Program, and received select agent handling certification from Centers 
for Disease Control and Prevention (CDC) for all laboratory staff and 
facilities. Standard operating procedures and protocols are in place 
for evidence handling and analytical flow processes.
    To provide reference microbiological material against which to 
compare suspect samples, the NBFAC has established a National 
Bioforensic Repository Collection (NBRC). The repository is developing 
and implementing a comprehensive management plan and acquisition 
strategy in FY 2005 and will continue implementation throughout FY 
2006.
    NBFAC has also taken several major steps to extend its analytical 
capabilities. It has implemented interagency agreements with other 
federal laboratories to provide capability for specialized analysis and 
surge requirements and it has implemented a robust research and 
development (R&D) initiative to develop next generation forensic tools. 
The R&D program focuses on: developing improved protocols for sample 
collection, preparation, and extraction; validating new genotyping 
approaches for more precise and rapid identification of suspect 
samples; and implementing novel methods for analyzing of the physical 
and chemical signatures of biothreat agents and their associated 
matrices to look for differences in the processes used to grow, 
harvest, process and deliver agents.

    RESPONSE AND RECOVERY
    Attack with a biological agent can cause widespread contamination 
of large outdoor urban areas and the included facilities and critical 
infrastructure that are beyond the scope of current protocols and 
procedures to address in a timely and cost effective manner. 
Recognizing the importance of the addressing these issues, Biodefense 
for the 21st Century has charged EPA, in coordination with other 
Federal departments, to develop strategies, guidelines and plans for 
decontamination of persons, equipment and facilities and has charged 
DHS with the lead in developing decontamination methodologies for 
critical infrastructures.
    To support these responsibilities, the S&T Directorate has focused 
on providing systems solutions through the use of so called domestic 
demonstrations and applications programs (DDAPs) which bring together 
users, technologies and procedures to demonstrate in integrated 
solution to a problem. This approach has been used successfully in the 
past to develop urban monitoring systems which later became BioWatch 
and detection and response systems in transit facilities (PROTECT) 
currently operating in several metropolitan subway systems. Two DDAPs 
are currently underway on the protection of critical infrastructures, 
using airports as a model system. The first of these, the PROACT 
program, has developed ``Guidelines to Improve Airport Preparedness 
against Chemical and Biological Terrorism'' that have been provided to 
the Transportation Security Administration(TSA) and the Federal 
Aviation Administration (FAA) for review and distribution to airports 
around the nation. The second of these, the Restoration DDAP, is 
focused on the recovery of an airport following a biological attack. 
This program in being conducted in collaboration with the San Francisco 
International Airport (SFO), the EPA, and CDC (NIOSH) and is focused on 
developing tools and protocols to significantly reduce the time it 
currently takes to decontaminate a facility. The major deliverable, due 
in FY 2006, is a pre-reviewed (by EPA) decontamination plan for SFO 
that can serve as a template/guideline for other airports in the nation 
and which will have been demonstrated in concert with the operational 
user/facility, responders and other federal partners to provide a 
systems solution to the problem.
    The S&T Directorate also co-chairs with EPA the Subcommittee of 
Decontamination Standards and Technology, assembled by the Committee on 
Homeland and National Security of the National Science and Technology 
Council. The objectives of the Subcommittee are to facilitate the 
development of consistent guidelines, testing protocols, certification 
methods, and reassessment strategies to address incidents involving 
biological and chemical agents. The Subcommittee will examine current 
barriers to standardization and interoperability between agencies and 
recommend strategies to remove such barriers. A technology gap analysis 
will be performed to develop a research initiative as well as 
addressing Human Decontamination issues.

    CONCLUSION
    The Department of Homeland Security and the S&T Directorate's 
Biological Countermeasures Portfolio fully support the national 
biodefense program as stated in Biodefense for the 21st Century, and 
other Homeland Security Presidential Directives. Moreover, these 
programs are conducted in an active collaboration with other Federal 
departments and agencies having a role in meeting this national 
priority, and are focused on reducing the threat of a biological attack 
against this nation's population and its agriculture and food critical 
infrastructures, and supports a science-based forensics and attribution 
capability.
    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 and I will be happy 
to answer any questions that you may have.

    Mr. Linder. Thank you, Dr. Vitko.
    Thank you all. Each of you is involved in, it seems to me, 
anticipating something and responding to it. Is anybody 
involved in finding how the intelligence community can 
intersect with the biological community to find the bad actors 
and prevent their actions?
    Dr. Gerberding?
    Dr. Gerberding. We have limited intersection in that regard 
right now. One of our most important domains currently is the 
recognition that CDC itself is a threat. And so, in cooperation 
with other agencies, we have come to grips with the fact that 
our own internal security and the security of the CDC is 
something that requires a much greater effort, so the guns and 
the guards and the other security measures that have been part 
of our portfolio of investments since 9/11 are there in part to 
deal with that component of prevention. But on a more global 
scale, as we learn about what are the signatures of people who 
are planning threats or what is the signature of someone who is 
working with a biological agent, these are areas where I think 
we have opportunities to expand and enhance our intersection 
with other intelligence agencies.
    Mr. Linder. Thank you.
    Mr. Vitko. Mr. Chairman, DHS's information analysis and 
infrastructure protection directorate has a significant effort 
in that area. Our intelligenceSec. 
    Mr. Linder. Dr. Vitko, you spend less than 2 percent of 
your budget on intelligence.
    Mr. Vitko. DHS does?
    Mr. Linder. Yes. Less than 2 percent.
    Dr. Fauci, does the vaccination for Ebola deal also with 
Marburg, or is it specific to Ebola?
    Dr. Fauci. We have two vaccines that we are testing, Mr. 
Chairman. One is a specific for Ebola. The hemorrhagic fevers 
in general with Lassa Marburg and Ebola are the ones we are 
worried about. The first one we have tested now that is shown 
to be safe and immunogenic in monkeys is specific for Ebola. We 
have a second-generation one that has been developed in 
collaboration with the Department of Defense, and that is one 
in which you have both Marburg and Ebola in the same construct. 
So we are working towards having a protection against the 
threats of hemorrhagic fevers.
    Mr. Linder. Is it time for us to start thinking about 
classes of drugs as opposed to one drug for one bug?
    Dr. Fauci. That is an extraordinarily good point, and in 
fact, that is the thinking right now of how we are approaching 
classes of microbes. We use the terminology, but I want to make 
sure we do that with a caveat, because it is not going to be 
all-encompassing--rather a little bit less than universal 
vaccination and antimicrobials. An example of that was recently 
noted in a nonbioterror microbe group B streptococcus, which is 
an infection that fundamentally infects pregnant women, who 
risk passing it on to their newborn infants. There has been a 
recent important breakthrough conceptually of being able to 
develop, by expressing all the genes of a particular group of 
subtypes, those overlapping antigens that in one vaccine could 
allow you to essentially have a vaccine against all the 
different types. So that is a first step towards the concept of 
universality, particularly within subtypes of a microbe. So we 
are working in that direction, Mr. Chairman.
    Mr. Linder. There have been several articles and TV shows 
lately talking about the risk of avian flu. How does a 
terrorist take advantage of that?
    Dr. Gerberding?
    Dr. Gerberding. Well, in this case, Mother Nature herself 
is a very effective terrorist, and we are respectful of her. 
But we recognize that influenza has some of the important 
characteristics of an excellent threat agent. It is easily 
transmissible. It is relatively easy to produce, and it is easy 
to modify or engineer. So it does have characteristics that, if 
a person were intent on modifying or creating an even worse 
influenza isolate, it is not beyond our imagination to consider 
that as part of our preparedness efforts.
    Mr. Linder. Dr. Vitko, you mentioned briefly an actual 
bioterrorism and countermeasure center.
    Mr. Vitko. Yes.
    Mr. Linder. The first time that was presented to us, it was 
going to be four labs. Then it was going to be three labs, and 
now it is two labs. What is the most recent iteration of that?
    Mr. Vitko. There are two main centers in there, the 
BioThreat Characterization Center, which does the laboratory 
experiments to reduce the uncertainties in known parameters 
about the threat and improve the assessments; and the second 
one is the National BioForensics Analysis Center, NBFAC, and 
that does the technical forensic analysis. The concept you had 
heard before, there is a broader--NBACC refers both to the 
center and to the hub programs. And so the other thing you 
probably heard in that context is the BioDefense Knowledge 
Center, which is in fact in Livermore Valley, California.
    Mr. Linder. I hope we have time for another round of 
questions. My time has expired. Mr. Langevin.
    Mr. Langevin. Thank you very much.
    Dr. Fauci, you touched on an issue that I wanted to 
address. This subcommittee had a hearing 2 weeks ago where we 
heard testimony from bioweapons experts, including Dr. Ken 
Alibek. And the chief concern they all expressed was that we 
are not ready to rapidly respond to new pathogens, and that 
known pathogens such as anthrax can be easily bioengineered to 
be resistant to known vaccines that we have in stockpile. Dr. 
Roger Brent, another one of the witnesses, compared the 
stockpiling of the vaccine to the Maginot line, a defense that 
can be defeated simply by going around it.
    What more can we do and are we doing enough to ensure that 
we could rapidly respond to new pathogens? Is BioShield the way 
to go? Some have suggested that, instead, we focus on 
developing the rapid bug-to-drug capability focused on the 
ability for rapid DNA sequencing of pathogens and quick 
development and deployment of countermeasures. So can you 
address that?
    Dr. Fauci. Yes, I would be happy to, Mr. Langevin. First of 
all, there is a weakness in the stockpiling of a particular 
countermeasure, a vaccine or an antibiotic, because of the 
potential capability of engineering around that. But it would 
be folly to not do that at all. To say that someone has the 
potential of engineering a smallpox virus that could elude 
antivirals--and we don't have a good antiviral--or that could 
divert the immune response away and, therefore, not stockpile a 
standard smallpox vaccine I think would be not a good idea at 
all.
    Having said that, we should be and are aware of the fact 
that you have to have countermeasures that would address the 
ability to divert bioweapons away from the countermeasures that 
we have already developed. And that is the reason why we are 
pursuing two areas and a third area that answers your last 
question, and that is, multiple antibiotics and antivirals that 
are against different targets. It is extremely difficult to 
engineer a microbe in which you divert away from virtually 
every target of an antimicrobial or an antiviral without 
mutating the microbe out of existence. It is not impossible, 
but it is very, very difficult to do. So the more different 
targets you have as the target of your countermeasure, the 
better off that you are. So there is no question about that.
    But the other issue of whether or not we should be looking 
at genomes--this is one of the major efforts at NIH in 
collaboration with CDC of sequencing the genomes of virtually 
all of the target agents, the agents that are suspect of being 
potential bioterror agents, and to literally be able to examine 
all the vulnerable points from both an antimicrobial standpoint 
as well as multiple overlapping antigens. So I believe that we 
have to do somewhat of a golden mean: We need to stockpile the 
things that are obvious, but don't rely just on one vaccine, 
one bug-or-one drug, one bug, but think in terms of the cross-
reactivity and the more universal approaches.
    Mr. Langevin. Dr. Gerberding, obviously our ability to 
respond to potential bioweapons attack is going to be largely 
dependent on not only countermeasures but how quickly we are 
aware of such an attack. And we rely heavily on the--in 
addition to sensors, also the public health system. At our 
visit to the CDC, I had asked you about your confidence in 
real-time information getting to the CDC or other government 
entities in terms of being aware of these potential threats or 
attacks; and you said we had really more work to do in the 
sense that you didn't give me a feeling that there was a high 
confidence or a robust system in place. Can you share with the 
committee your thoughts on our ability to communicate real-time 
with the public health system and our ability to respond?
    Dr. Gerberding. Thank you. In terms of detection, there is 
variability across the various agents. We have many smallpox 
false alarms now, and our system is very sensitive to the 
potential for a smallpox attack in an individual with a rash or 
a fever that is suspicious. For some other conditions, it is 
much more difficult because their initial presentation can be 
subtle, and this is where the BioSense system becomes very 
important. This is our first year of funding for BioSense, and 
by the end of this year, we will have sentinel hospitals and 
emergency rooms, intensive care units, and laboratories 
connected from some of the cities involved in our Cities 
Readiness Initiative that are linked to the BioWatch 
Environmental Protection Program. And, if all goes well by the 
end of next year, we will have all of those facilities and 
those catchments connected up in real-time so that if someone 
visits the emergency room with something that could be 
inhalation anthrax, we will have that in our system in real-
time.
    Internationally, we have a bigger problem. We have seen 
even with the cases of avian influenza that are emerging out of 
Asia now, that sometimes we are seeing a lag of up to 30 days 
before we are aware that a case has occurred. So we have a 
very, very big effort under way to try to decrease that lag 
time in the international arena.
    Mr. Langevin. And your interaction with pharmacies, you had 
raised the issue that you used to have good reporting from the 
pharmacy network, and now that is not as robust. Could you 
share that with the committee?
    Dr. Gerberding. Yes. For a while, we were able to receive 
information I think from about 80 percent market share across 
the country of over-the-counter purchases for certain 
conditions like influenza. That system has become more 
expensive than we can afford, so we are replacing it with a 
different mechanism for getting information about purchases. We 
believe that our ability to collect them through billing 
records and through other pharmaceutical resources is going to 
improve.
    We also currently--I want to acknowledge our Department of 
Defense partners here, because right now today we are getting 
real-time information from the Department of Defense and the VA 
medical facilities around the country that includes visits, 
procedures, diagnoses, and other critical indicators. Because 
those facilities are so geographically distributed, they are 
already providing somewhat of a sentinel map that proved to 
perform very well during last year's flu vaccine shortage.
    Mr. Langevin. Is there something you need from this 
Congress with respect to pharmacies and the reporting that they 
could do to you?
    Dr. Gerberding. Let me get updated on that this week, and I 
will get back to you for the record. Thank you.
    Mr. Langevin. I see my time has expired, but I want to 
thank you all for your testimony.
    Dr. Gerberding. Thank you.
    Mr. Linder. Mr. Shays is recognized for 5 minutes.
    Mr. Shays. Thank you, Mr. Chairman.
    In the work that I do in my national security subcommittee 
that we have oversight of Defense, State Department and 
Homeland Security, and all agencies that interact on terrorism, 
we had a hearing with noted medical scholars, and one ran a 
major medical magazine. And he concluded the hearing by 
saying--and this was pre-9/11--he concluded the hearing by 
saying: Congressman, I wanted to share my biggest concern. His 
biggest concern was, he said in so many words, that a small 
group of dedicated scientists could create an altered 
biological agent that could wipe out humanity as we know it.
    I want you each to react to that statement in these terms: 
Is it something that concerns you? Is it something that is a 
fear without justification? And so on.
    Dr. Gerberding. I think you are asking us to imagine the 
unimaginable. Technically, we know it is relatively easy these 
days to engineer and reengineer agents. So the technical 
obstacles are relatively trivial. What is challenging is the 
distribution of those agents in manners that would bypass our 
capacity to recognize and intervene effectively. And I think we 
are still somewhat confident that, for many of the pathogens, 
the capability of causing mass destruction is limited because 
of the nature of the agent and the limitations of distribution. 
However, as we said when we were concerned about smallpox 
preparedness, there are certainly opportunities to distribute 
or reengineer a smallpox virus that could certainly cause 
terror. It doesn't take very many casualties to upset our 
economy and to cause major disruption in our society.
    So I think these are things that we as Federal agencies 
need to and are imagining, and we are doing all of the things 
that we as scientists can do to try to stay one step ahead of 
the terrorists in this regard. It is a big challenge.
    Dr. Fauci. My response, Mr. Shays, is not significantly 
different at all from Dr. Gerberding's. Technically speaking, 
you can do almost anything with a microbe. The real question 
is, will you end up with a microbe that functionally can do the 
things that the concerned person that you are hearing said, 
namely, essentially wipe out everyone from the face of the 
earth? Again, that is conceivable--anything is possible. 
However, it would be very, very difficult to do that, 
extraordinarily difficult, even in the best of hands to not 
only do the engineering to get a microbe that has the 
characteristics, but be able to spread it in a way in which it 
has virulence, transmissibility, and the ability to spread in a 
sustained, transmissible way. Not impossible, but very, very 
difficult to do.
    General Schoomaker. Sir, first of all, I would be foolish 
to try to elaborate on what my distinguished colleagues who are 
really experts in this area have said already.
    Mr. Shays. But do you basically agree with their points?
    General Schoomaker. Yes, sir. I would add that the U.S. 
military has always been concerned conceptually about this 
notion--to draw on something that Dr. Gerberding talked about 
already, that nature is doing on a continuous basis to us, and 
that we have to be prepared in our military role to be able to 
respond or to anticipate virtually any bio-event that is out 
there that Soldiers, Sailors, Airmen, Marines, and Coast Guard 
might encounter. So we go back to reinforcing I think the whole 
interagency cooperation and need to understand the immune 
system, to understand the biology of these bugs, and to have a 
rapidly responsive method of handling that.
    Mr. Vitko. I basically agree with the statements made prior 
to me, especially those of Dr. Fauci, on the real difficulty of 
functionally engineering an organism to accomplish what you 
want in a radical way.
    With that said, there are smaller steps that can be done in 
engineering organisms. And the question is, how big a step are 
you trying to make? And in the case that we worked out the 
strategy with HHS and DOD for engineered threats we tried to 
build in our best guesses, estimates, at the difficulty of 
engineering in certain traits and a strategy for getting there. 
So, for example, antibiotic resistance to a single drug is much 
more easy to introduce than antibiotic resistance to multiple 
drugs than making a total de novo kind of pathogen that has a 
desired set of properties.
    Mr. Shays. My time has clearly run out, but let me just say 
for the next round of questions when we get there: Going 
through the Soviet Union, you would see pathogens that they 
would store, whether they were threats to animals or humans, 
they would justify in some cases by saying we don't know, when 
the perma-frost goes, what kind of biological agents we will 
deal with.
    But having said that, I would like to in next round ask you 
to respond to all the potential viruses and so on that are 
stored by colleges and research firms that we may not even have 
a good sense of. So that will be in my second round.
    Mr. Linder. Dr. Christensen is recognized for 5 minutes.
    Mrs. Christensen. Thank you, Mr. Chairman. And I very much 
appreciate your having this hearing, and I hope that we will 
leave here with a clearer understanding of who does what and be 
able to get some answers to our concerns, with so many agencies 
involved and research for biologic countermeasures and our 
preparedness for bioterrorism, as to why we are moving still so 
slowly, it seems to me.
    I guess I would start my questioning with General 
Schoomaker, and but others can answer. If I went through the 
testimony correctly, there are four new labs coming on line at 
CDC, maybe two at NIH, and then the one at Fort Detrick. What I 
want to know is which lab does what? Are we duplicating efforts 
here? Do we need a new lab, given that we have labs at CDC and 
NIH and they are creating more--which, what is the 
responsibility of each of these labs, and are we duplicating 
effort?
    General Schoomaker. No, ma'am. I think that is a legitimate 
concern, and it is one that has been expressed. I would say 
that every one of the labs, as I think has been outlined, has a 
different role in this chain of custody of both understanding 
the basic science and of the immune system of the human and 
potential host, as well as the microbes that we are dealing 
with, and then moving those good ideas and that basic 
laboratory science through a test and evaluation system which 
tests safety and efficacy to production. And, between threat 
analysis and anticipating what agents are out there to the 
science that is required to understand these agents better and 
the immune system of the host, to test and evaluation, that for 
USAMRIID is one of our core competencies, the ability--
    Mrs. Christensen. So you do test and evaluation of the 
basic science that is developed at NIH?
    General Schoomaker. In the context of what we are talking 
here, ma'am, in the protection of the public, U.S. public 
against these hazards, I would say, yes. We have basic 
scientists that are addressing militarily relevant concerns. 
But for this, one of our major contributions at USAMRIID is 
that we are a large laboratory with a great experience, 
expertise, as well as facilities to test aerosolized agents and 
to test the effectiveness of vaccines or other agents that 
would be used to ameliorate those.
    Mrs. Christensen. Dr. Fauci?
    Dr. Fauci. I just might add that we certainly don't need an 
unlimited amount of BSL4s. I think the plans we have now will 
likely meet the needs for the foreseeable future. The NIH does 
not have a BSL4 on its campus. The NIH is building a BSL4 up in 
Fort Detrick in order to do the kinds of research that are part 
of our expanded plan of research. And literally, the time 
needed in that facility would not be able to accommodate what 
we were doing at the same time as what the Department of 
Defense is doing up there. The BSL4 that is being built in 
Hamilton, Montana in a laboratory is going to meet the needs of 
the critical mass of scientists who are now working on 
biodefense there, and then obviously there is a very important 
facility at the CDC which Dr. Gerberding will address.
    Mrs. Christensen. Dr. Gerberding, could I ask you a 
question so that I can get it in and you can answer both? You 
say that in your statement that, after the decision is made, 
the supplies that treat the countermeasures can get to any 
location in our country within 12 hours. In the intervening 12 
hours, between the event and the time the supplies get there, 
what level of preparedness is the public health system at right 
now in terms of containing whatever the event is, treating the 
immediate effects, controlling the spread, and then to 
distributing or applying whatever is sent from the stockpiles?
    Dr. Gerberding. Let me speak to the laboratory question 
first. One of those buildings that I showed you is housing for 
BSL laboratories that CDC has desperately needed. Right now we 
can't simultaneously work on Ebola and smallpox, but we need to 
be working on those and some other agents that need those labs. 
But what is exciting about the Fort Detrick campus is not just 
the agencies coming together and co-locating; it is the 
scientific synergy that can be created by bringing people with 
the variety of expert capabilities together to work 
collaboratively. This is the era of big science, and getting 
the right critical mass of the very best minds in the country 
together to contribute their unique capabilities to these 
problems is, in my opinion, essential. I mean, it has also 
allowed us to look at some gaps. For example, CDC's role in 
this campus is to be focusing in on environmental microbiology, 
which speaks to the question you asked, your second question 
about what happens in the first 12 hours. If we have a 
contaminated environment like occurred here in Congress in 
2001, the science around: How do you define the extent of 
contamination, and how do you ameliorate that contaminant, and 
how do you know you have done it, and how clean is clean, and 
when is it clean enough? Those are questions that we 
desperately need scientific answers to, and these are the kind 
of things that we think, by taking advantage of the aerosol lab 
and the forensics capabilities that Homeland is building and 
CDC's unique microbiologic science capabilities, we ought to be 
able to get to those answers faster. That also is predicated 
under the assumption that we will engage the EPA and the other 
agencies that have primary leadership in these areas.
    Mr. Linder. Mr. Simmons, you are recognized for five 
minutes.
    Mr. Simmons. Thank you, Mr. Chairman.
    And I thank the distinguished panel made up of medical 
doctors and Ph.D.s--I think all four of you have at least your 
Ph.D. or your medical degree, so congratulations, even the 
general, yes, indeed.
    The chairman made the comment earlier about prevention; 
there is a lot of talk about identifying problems and 
responding to them in a proper way, and that is entirely 
appropriate. As the Chairman of the Intelligence and 
Information Sharing Subcommittee of this committee, my interest 
is in identifying the threat capabilities, and then trying to 
prevent these attacks from taking place in the first place.
    Clearly, the United States intelligence community plays a 
role in this, certainly in threat assessment, in determining 
capabilities, but then more importantly, and perhaps more 
difficult, determining what the plans and intentions may be.
    My first question goes to the issue, do each of you or all 
of you, in your current capacity, provide requirements to and 
get products back from the U.S. Intelligence Community at a 
classified level that is useful to you in attempting to 
determine the threat and to prevent an attack? And I will 
follow that with a second question while you consider the 
first.
    The al-Qa'ida handbook, which is a translation of an al-
Qa'ida document that was taken in Manchester, England a couple 
years ago, makes reference to public sources. And the al-Qa'ida 
guidance is, use public sources openly and without resorting to 
illegal means. It is possible to gather at least 80 percent of 
information about the enemy from public sources. They go on to 
mention books, magazines, newspapers, periodicals, official 
publications and broadcasts.
    It occurs to me that open sources of information lend 
themselves particularly to this area, because so much of what 
we know about research and development in medicine is shared 
through professional journals and books. And let me give you an 
example.
    Pfizer Corporation is currently looking into the use of 
aerosols for diabetes treatments so you don't take a shot 
through the skin, you use an aerosol, but the vaporization is 
critically important for the system to work. It is my 
understanding that the same vaporization, or the technology of 
that vaporization, can be used in a biological weapon that 
would be airborne, and perhaps dispatched in a theater, a 
building's air conditioning system, subway system, train or any 
close space.
    To what extent do any of your agencies go into the open 
source with a red team mindset to see what, in fact, the bad 
guys might be looking at to use to develop and spread 
biological agents; to what extent are you using open sources to 
develop your intelligence assessments?
    Dr. Gerberding. Let me address your first question first, 
and then I guess come around again.
    CDC is linked into the intelligence community in several 
ways. We have more than one FBI agent who is permanently 
stationed at CDC, and we are very closely allied with the 
regional FBI Center in Atlanta. We have reciprocal training. We 
have trained more than 8,000 local public health and law 
enforcement officials through our combined forensic 
epidemiology program so that we can investigate at the local 
level.
    But we also have analysts at CDC. We are coming online with 
a data stream so that we will have primary source information, 
and we are also working with the Department of Defense on being 
a note in the medical intelligence information that the 
Department of Defense is creating.
    So we have a number of systems that are likely to be 
operational when we move into our new headquarters building on 
September 12th. That is one of our deadlines for getting these 
systems interoperable.
    Dr. Fauci. Just to amplify a bit, at the NIH, which does a 
lot of the research involved, we have several taps into 
intelligence that help us direct development of 
countermeasures. We are in close collaboration with the CDC and 
their plug into the intelligence community. We rely heavily on 
the material threat assessments that come from the Department 
of Homeland Security. And we all have top secret security 
clearance and get briefed on a relatively regular basis by the 
CIA and the FBI.
    General Schoomaker. Sir, one linkage to the intelligence 
community, as these others have said, the Medical Research and 
Material Command, in fact, the whole of the DoD is linked with 
the DIA, Defense Intelligence Agency, as well as the Armed 
Forces Medical Intelligence Center, which is a joint command. 
It is collocated at Fort Detrick with MRMC. In fact, to go back 
to a theme that Dr. Gerberding brought up, the critical mass of 
people working on these and sharing information, the design of 
this campus is, in fact, especially made so that it shares 
information. We do have a very close linkage with the Armed 
Forces Medical Center.
    As far as aerosolization is concerned, and the risk, our 
people at USAMRIID are national, international experts on 
aerosols, I would like to take your question for the record and 
get back to you on that.
    Mr. Simmons. Thank you.
    Mr. Vitko. Our information analysis analysts work very 
closely, as you have heard in previous testimony, with the FBI, 
CIA, NCTC and other agencies. They have constructed a multi-
agency intelligence team to support the risk assessments when 
doing material threat assessments. We make use of both that 
formal intelligence information, and we provide them cues and 
products to look for from the bioterror characterization 
activities that we do, but we make extensive use of open source 
information in doing the material threat assessments that we 
undertake. So we think it is a very important source.
    Mr. Simmons. I thank the Chair.
    Mr. Linder. Mr. Dicks is recognized for 5 minutes.
    Mr. Dicks. Thank you very much, Mr. Chairman.
    Mr. Vitko, can you walk us through the process of 
developing a material threat assessment?
    Mr. Vitko. It would be my pleasure, Congressman.
    Material threat assessment starts with selecting agents 
that might be of significant concern. The next piece that you 
do is you try to--it is intelligence in form, that is, what do 
we understand about potential adversaries and their 
capabilities, but then it moves on to the scientific process of 
trying to establish the feasibility of a terrorist constructing 
a weapon.
    So we start asking questions about how would they obtain an 
organism, to what level could they grow it out, what resources 
would it take, is it storable; how would you disseminate it; 
what are the potential scenarios; how long does that agent then 
survive in the environment or the food processing or water 
processing kinds of system it goes through, and it takes that 
through to the consequence end.
    Throughout that, in each of those stages, we involve the 
appropriate experts. So typically in a material threat 
assessment, there are 40 to 50 experts involved. There are 
typically, again, two interim reviews, and then a final review 
and vetting at both an unclassified level and a classified 
level.
    Mr. Dicks. Do any of these entities represented here by Dr. 
Fauci, Dr. Gerberding and General Schoomaker, are they involved 
in this, or is this your people--
    Mr. Vitko. Absolutely.
    Mr. Dicks. So do you have a collaborative--
    Mr. Vitko. This is not only multi-agency, it involves the 
academic community, it involves the entire--
    Mr. Dicks. Is that why it takes so long? We have only done 
four of these. I am told that there are about 60 possibilities 
for material threat assessments. Is that correct, is the list 
that long?
    Mr. Vitko. Well, the 60 agents that you told about are the 
CDC's category A, B and C list. Clearly some of those are 
higher priority concern than others, that is why they are--
    Mr. Dicks. I assume you are doing the higher priority 
first?
    Mr. Vitko. We are doing the higher ones, and we have 
essentially finished the category A agents. The reason it takes 
so long is because, if you look at each of these--and there are 
typically, as I described, 30 to 40 parameters in trying to 
assess the consequences of this kind of event, if I am off even 
by a factor of two in each of those, I can have large 
uncertainties in what comes out in the end. We try to pinpoint 
that down as well as we can--there are still uncertainties--and 
we try to reduce that and to develop a consensus understanding 
in the community around that.
    Mr. Dicks. Now, one of the things we heard at our last 
hearing was that, because it is becoming so easy to bioengineer 
pathogens for vaccine resistance, that stockpiling of vaccines 
may not be the right approach. One of our witnesses likened the 
vaccine stockpile to the Maginot Line of World War II, which 
the German Army simply went around. They suggested that we 
focus on developing bug to drug capability. What advice do you 
have for us on this? I mean, we have been upset that maybe you 
are not getting these material threat assessments over to DHS, 
and then they can't use the money in the BioShield Fund to go 
out and get various drugs as countermeasures.
    Some people suggest that that may not be the right 
approach. What can you tell us about this?
    Dr. Fauci. I think we need a balance of multiple 
approaches, which we are implementing, Mr. Dicks. We certainly 
need to stockpile vaccines for the obvious threats, and 
smallpox is one of them. We are also keenly aware of the 
theoretical possibility of being able to engineer a microbe to 
evade vaccine, linked to a mechanism, for example, of 
suppressing the body's immune system.
    So to say one or the other I think would not be the 
appropriate response, but to do a reasonable amount of 
stockpiles for the obvious, but don't think that you are now 
totally protected, but direct your research to be able to 
circumvent attempts to get around the--
    Mr. Dicks. Dr. Fauci, you have a lot of experience and 
people have a lot of confidence in you. Are you concerned about 
the pace of getting these material threat assessments done and 
getting commitments made out of the BioShield Fund? Does this 
worry you, or do you think we are on a reasonable pace here?
    Dr. Fauci. I am not satisfied, Mr. Dicks. I am aware of how 
difficult it is, as articulated by Dr. Vitko about getting them 
out, and I think we will soon be getting significantly more 
out. But I agree with you that there is concern about getting 
it so that we can then steer our research and development 
efforts--
    Mr. Dicks. The companies are particularly concerned, one 
about liability, one, that the bigger companies won't be 
involved because they can make more money doing other things--
we watch those every night on television--and that they are 
concerned about the pace of the commitments made by DHS, and 
they are basically pointing the finger at Dr. Vitko and his 
people and saying they are not getting these material threat 
assessments done.
    Until DHS gets it, they can't take any steps. In fact, 
there was one on radiological that I am told that went over 
there and was sent back. And there was a lot of confusion about 
where it stood.
    So this is worrisome to us because we don't have the same 
kind of resources here that we had in Nunn-Lugar and some other 
things, and somehow we have to encourage and move the process a 
little more rapidly.
    Dr. Fauci. I agree, Mr. Dicks. There are a couple of issues 
that you brought up, I will very briefly address them.
    I agree there is a concern, and we need to move faster and 
do better about getting them out, and DHS is clearly addressing 
that. They are very well aware of that.
    The other is--
    Mr. Dicks. I should have said HHS, excuse me, they are the 
ones that have to spend the money out of the Biofund.
    Dr. Fauci. We have to spend the money out of the BioShield. 
That is my concern because we want to get it out there and get 
those countermeasures out.
    But the point you made about the big companies is something 
that we at the Department, particularly Secretary Leavitt, are 
concerned about, and are trying to address: how do we better 
incentivize the larger companies to get involved? The mechanism 
we have in place now has been helpful, but we really need to do 
better to get them involved. Liability is clearly one of them 
that you mentioned, and this is an issue of very intensive 
discussion at the present time.
    Mr. Dicks. Even the smaller companies are worried about 
liability.
    Dr. Fauci. Everybody is, but if you want to get the big 
players in, they have much more to lose than the others. They 
don't want to step on ground that is going to endanger a large 
enterprise.
    Mr. Linder. The time of the gentleman has expired.
    The gentleman from Texas is recognized for 5 minutes.
    Mr. McCaul. Thank you, Mr. Chairman. This is really a 
follow-up to Mr. Dicks' question.
    Four of the 60 material threat assessments have been done. 
What is your timetable for completing the 60, and would do you 
favor, as he mentioned, immunity from liability for the big 
pharmaceutical companies to get them incentivized to 
participate?
    Mr. Vitko. I will speak to the timetable. We have done 
material threat assessments, three more assessments are in 
their final review. We will have done 29 agents by January of 
2006 in terms of risk assessments. Those are not full material 
threat assessments, those are risk assessments, so in some 
cases there may be additional details to be pursued, and that 
is where the pace of that is.
    Mr. McCaul. Do you need additional resources to speed up 
the process?
    Mr. Vitko. Actually, we have the financial resources. This 
is a question of having the right people and the time it takes 
to do that, but thank you very much for the offer.
    MR. McCaul. I don't know if it is an offer--
    Dr. Fauci. The debate for liability protection is up for 
some considerable discussion, you can go all the way to one 
side, have complete indemnification for everything--that I 
think would be a hard one to sell--but better than we are doing 
now with regard to liability. I think there is universal 
agreement that we need to address the liability issue better 
than it being addressed currently.
    MR. McCaul. There is more out of curiosity. I assume most 
of you read the Hot Zone way back when. I read it again about a 
year ago, and the first couple of chapters are really a page 
turner, and scary. The person comes down with the Ebola virus, 
it is a Marburg strain, I think, and begins hemorrhaging on the 
airplane. When are we going to have a material threat 
assessments for that agent?
    And secondly, have we ever weaponized--has it ever been 
weaponized, either by us or the Soviets? And I don't know if 
you can answer it in open hearing. And is there an airborne 
strain to that virus that we know of today?
    Mr. Vitko. I will speak to the first part--
    Mr. Linder. Let's not have the answer in open session.
    Mr. McCaul. I will withdraw the question. Perhaps I can get 
that information in a closed hearing.
    Then lastly, we passed the faster and smarter funding bill 
in the House, and that provided grants for First Responders. 
But as I understand it, DHS does not have--or HHS, I should 
say, does not have a similar mechanism for bioterrorism grants. 
My State of Texas always ranks dead last per capita, along with 
New York and California on that type of funding. Would you 
recommend--what are your thoughts on changing that formula to a 
risk-based formula for bioterrorism grants? And perhaps, Dr. 
Gerberding, maybe your expertise.
    Dr. Gerberding. Thank you. It is a dilemma to assure that 
we have a network of protection in every location in the 
country and yet pay attention to the places where the risk may 
or may not be greater but the impact is large. And certainly in 
urban areas like New York City, we know that the impact factor 
is huge.
    I always harken back to anthrax when I remember the night 
that I stayed up all night with the City of Fort Collins, 
Colorado when there was a white powder in their post office. 
That is probably not a city that would rank high on the threat 
assessment scale, but it was a community that had exactly the 
same requirements as any other anthrax-exposed community.
    I think one of the things that we have done this year 
through the City Readiness Initiative is to dedicate some--more 
than $30 million to a set of 20 cities plus the D.C. area to 
invest in much more depth in countermeasure delivery and some 
of the additional linkages between the environmental assessment 
capabilities, the laboratory and our ability to deliver 
countermeasures. So that's a step towards focusing on higher 
threat environments. And I know Secretary Leavitt is looking 
very closely, working with the stakeholders in these 
communities to determine what is the right balance between a 
seamless network and yet assuring where people would be 
experiencing the most impact that we have the best preparedness 
possible.
    Mr. McCaul. Okay, thank you. I will yield the balance of my 
time. Thank you.
    Mr. Linder. The gentleman from Mississippi is recognized 
for 5 minutes.
    Mr. Thompson. Thank you very much, Mr. Chairman.
    Dr. Fauci, I am looking at a document relative to 
biodefense countermeasures, and I see anthrax is listed on 
here; and it says that we have a new vaccine tested and 
procured under the project BioShield; is that correct?
    Dr. Fauci. That is correct. The contract was signed for 
procurement. The payment for that is upon delivery to the 
Strategic National Stockpile. The work that is going on with 
the recombinant protective antigen, which is the next 
generation of anthrax vaccine, is safety studies in phase one, 
and now going into phase two, as well as work in an animal 
model, to determine if you can protect with your vaccine 
against an aerosolized challenge.
    Mr. Thompson. Can you tell me, how old is that contract 
right now?
    Dr. Fauci. The contract was signed within this past year, 
so it was in 2005 that it was signed.
    Mr. Thompson. Can you tell me the rationale for giving the 
contract to a company that had never produced the vaccine?
    Dr. Fauci. This was a decision at the Department, but I 
would be happy to--that was not my decision, but I would be 
happy to address it.
    The rationale is that this is under a typical classical 
contract bid procedure where the proposals and response to 
Request For Proposals are examined and rated and prioritized, 
and the contract is let on the basis of a rating and ranking 
among the competing entities that put contract proposals in.
    We are dealing with a very unusual situation, Mr. Thompson. 
If we were to exclude now any company that would engage in a 
BioShield procurement who has not developed a vaccine, we would 
exclude most everyone who would be interested in doing that.
    Mr. Thompson. Well, then I understand there are a number of 
companies who have produced this anthrax vaccine that we didn't 
select. So using your rationale, if we have companies who do 
it, why would we choose a company that has never produced a 
vaccine?
    Dr. Fauci. That gets into the contract law of 
prioritization and the decision that is made on what the 
factors are in having a procurement officer decide that one is 
better than the other, and I don't think it would be 
appropriate for me to address why one got it versus the other, 
that gets into contract law that I am a little bit concerned 
about making a statement about why--
    Mr. Thompson. Let me tell you why; because in the process 
of awarding the contract, we went out and bought some vaccine 
from another company just to have some around.
    Dr. Fauci. Right.
    Mr. Thompson. And I am trying to figure out the logic of 
going out and buying some vaccine from one company and ordering 
some from other company that has never produced it.
    Dr. Fauci. Right. I cannot give you the precise answer for 
that, but I can create a scenario that is very compatible with 
what you just described.
    You have a vaccine that you want to improve upon, and you 
sign a contract for the development of a vaccine that you could 
have in your stockpile that is better than the current vaccine, 
but during the developmental process of that new vaccine, there 
is a gap of not having enough on hand of a vaccine that may not 
be the optimal vaccine, but at least it is a vaccine that you 
could use as a stop gap. That could have been the rationale 
that the Department used. And as I mentioned, that was not my 
decision because I do the research, I don't do the procurement.
    Mr. Thompson. Well, you produced a document saying it was 
done, and that is why I raised the question.
    Dr. Fauci. I appreciate that, Mr. Thompson, but I am trying 
to explain how that got in there.
    Mr. Thompson. Do you know of any other vaccines that have 
been similarly situated?
    Dr. Fauci. When you say similar situation, you mean--
    Mr. Thompson. That we have had to go out and procure a 
vaccine from another source and we contracted with another 
source to produce it.
    Dr. Fauci. Well, what we are dealing with right now in the 
biodefense arena does not lend itself to vaccines that have 
already been made for a particular microbe. The other one that 
is amenable to vaccine protection would be smallpox, that is 
the other example with anthrax. We had a smallpox vaccine, we 
had an anthrax vaccine. We were down to virtually no doses, 18 
million doses of smallpox vaccine. The companies that 
originally made it were long out of the business of making 
smallpox vaccines, so that would be the other example, so there 
are really only two.
    I would might also add, Mr. Thompson, that the rPA vaccine 
and the AVA vaccine for anthrax are really two different 
vaccines, they are not the same. One is the supernatant of the 
anthrax which contains all of the antigens. The rPA was the 
purified component. We wanted to go with the more purified 
component. One, it was very likely it would require less 
immunization doses to get us where we wanted to be, and the 
other, there was the concern about issues, be they verified or 
not, about the baggage associated with the safety of the 
original anthrax vaccine.
    Mr. Thompson. Thank you, Mr. Chairman.
    Mr. Linder. The chairman recognizes the gentleman from 
Louisiana for 5 minutes.
    Mr. Jindal. Thank you, Mr. Chairman, thank you for calling 
this hearing.
    I want to thank the witnesses. I have had the privilege of 
working with at least two of them before, so I want to thank 
you for taking the time to come and talk to us today.
    I had three broad areas that I wanted to ask questions in, 
we may not have time to get to each of them, but I want to 
share with you the three questions and give you each a chance 
to respond.
    The first was, on one of his last days as working as the 
Secretary of Health and Human Services, Secretary Thompson 
talked about the fact that he was somewhat surprised we haven't 
yet to see an attack on our food supply chain, given the 
vulnerabilities. I would like your response to that assessment, 
whether you think we have taken steps, significant and enough 
steps since September 11, 2001 to secure our food safety from a 
by bioterrorist attack.
    The second is--and I know they are not mutually exclusive, 
but the second is, how do we set priorities when it comes to 
preparing our public health infrastructure from the threat of a 
bioterrorist, a man-made attack, versus a naturally-occurring 
pandemic, and which do you think is more likely to actually 
occur in a short-term horizon over the next few years?
    And again, I know they are not mutually exclusive. The 
ideal answer is it would take and build defenses there to 
protect our Nation from both.
    Third, and finally, I remember all too well how we didn't 
have a robust, comprehensive surveillance system on 9/11 for a 
bioterrorist attack, how we had many local county health units 
that didn't have 24-hour, seven-day-a-week communications 
ability, and I know we have come a long way since then.
    I would like your assessment, given BioWatch, the Global 
Disease Detection Initiative and some of these other things, 
and I know CDC is involved with many of these things, how close 
are we to getting real-time information? And within that, if 
you could comment on the fact, the development of sensors that 
could give us real-time data instead of just 24 hour data.
    And again, I know I have asked a lot of questions, and I 
would appreciate your comments on any part of those three 
during the time that we have got.
    Dr. Gerberding. I will try to give short answers and if you 
need more detail we can get back to you for the record.
    With respect to food safety, I will speak from the CDC 
perspective. Our role is primarily the surveillance of events 
potentially related to food-borne problems; and second, 
obviously safe food handling, the so-called Farm-To-Table 
initiatives on which we collaborate with FDA and USDA.
    We have made a lot of progress in food safety. The FDA 
could tell you about the enhanced food inspection systems, the 
food laboratory system that is now part of the linkage into the 
Laboratory Response Network.
    At CDC, we have a system called Pulse Net, and we have been 
able to decrease the time from contaminated food to detection 
and public health response sequentially over the last several 
years by using methodologies that are based on fingerprinting 
of the agent and comparing those in the database of CDC, so 
that if there is a hamburger problem and the case is in 
Colorado and there is a case in New Hampshire, we have the 
fingerprints collected centrally and can immediately say that 
shouldn't happen, there must be a point source outbreak going 
on here.
    With respect to the likelihood of bioterror versus mother 
terror--mother nature as a terrorist--I think the fact is we 
have to prepare for both. And one of the things I have the most 
confidence in right now is, from a CDC perspective, the 
investments that we are making in terrorism preparedness are 
serving us very well across the State and local health system 
for ordinary threats.
    This past year I visited Orange County Health Department. 
They described to me in very explicit terms how helpful the 
smallpox preparedness planning process was in dealing with the 
flu vaccine shortage this year. In Pennsylvania, we heard 
stories about how preparedness efforts have led to a much more 
rapid immunization program when there was a food-borne 
hepatitis A outbreak detected in a community. And on and on 
again, the public health benefits from these investments are 
paying off every day for people from ordinary health problems, 
but each one of those is also an exercise, and every time we 
use these capacities to deal with a health threat, we have the 
opportunity to improve. And that is part of, I think, the 
answer to your last question, which is that preparedness isn't 
all or none, it is a process. Just when we achieve milestones, 
we have the responsibility to imagine the next challenge and to 
continue to move in that direction.
    So our Biosense program, the real-time surveillance 
capacity is doing just that this year, creating the linkages to 
the health system so that we are not talking about a daily or 
weekly, or worse, handwritten reports of events, we are getting 
them as they occur and as people seek medical attention or 
through the BioWatch system, before human exposure occurs and 
we are still dealing with it at the environmental or the 
prehealth threat stage.
    A lot of work, these investments have made a big 
difference, but they require sustainability, and we have a lot 
more work to do. So we are making progress, but there is more 
on our plate.
    Dr. Fauci. Just very briefly, with regard to the food 
supply, many of the food-borne pathogens are part of the 
category B and category C of the CDC agents. So on our research 
agenda, we do address those with countermeasures.
    If you would note on my last slide, the map I show is 
global examples of emerging and reemerging diseases. I agree 
completely with Dr. Gerberding, we don't consider separately 
deliberately emerging and naturally occurring. And in our 
infrastructure, our intellectual capital and the research we 
do, our regional centers of excellence are called Regional 
Centers of Excellence For BioDefense and Emerging Infectious 
Diseases. So we think it just makes total sense to consider 
them as a group. We worry about both of them and we address 
them in very similar manners.
    Mr. Jindal. My time is expired, but I just want to thank 
the witnesses for your service, and thank you for appearing 
here today.
    Mr. Linder. The gentlelady from California is recognized 
for 5 minutes.
    Ms. Harman. Thank you, Mr. Chairman.
    This is a very capable panel. It gives me great comfort--
and I worry a lot about potential attacks on our country, it 
gives me great comfort to hear them and to know the progress 
that they are making, individually and collectively.
    You and I and several others went to Atlanta about a month 
after 9/11 to a dilapidated old place called the Centers For 
Disease Control. What a dump, it reminded me of my public high 
school in Los Angeles, World War II bungalows, wiring on the 
outside, police tape across rooms where the ceiling had caved 
in, refrigerators in the hallways, I mean, just a mess. And I 
am thrilled to see the reinvention of CDC, which is clearly, to 
me, the tip of the spear in the effort to fight and get a 
handle on bioterror. If the CDC doesn't work, we are never 
going to make all this work.
    But I want to congratulate Dr. Gerberding and also thank 
her for making a visit very early in her tenure to Harbor-UCLA 
in California, a public health service hospital, which is one 
of the premiere trauma centers in Los Angeles County, but also 
one of the premiere teaching hospitals in the country, and I 
really appreciated that.
    I want to continue where Dr. Christensen left off. She was 
asking about the public health network. And it seems to me, as 
good as you all are and as much as you can find out, if we 
don't have treatment centers and research centers and centers 
that can identify diseases when they walk in the door or arise 
nearby, we still don't have the capability we need. So my 
question is about our public health network and how good is it, 
what other help does it need, what should we be doing, and how 
does it mesh with the cutting edge research that all of you do.
    Dr. Gerberding. Thank you. I think it is important to 
emphasize that our network is only as strong as its weakest 
link. And we started in the hole. It wasn't just the CDC that 
was dilapidated, we are dealing with a public health system 
that, for many decades, had been woefully neglected, and it is 
going to take a long and sustained effort to bring it up to 
contemporary 2001 standards. Global connectivity and speed are 
the requirements of our thinking these days.
    I will, however, say that the progress has been incredible. 
I think we have health departments that have been revitalized. 
We are learning a lot from success stories. I visited the State 
of Nebraska, they have an exemplary preparedness program there 
which deals both with the rural as well as the urban issues.
    One of the things we learned there was that leadership from 
the top in the State is essential to success. If the governor 
is engaged and you have competent people at the various 
positions that our agencies all represent, you have a much 
greater chance of having a good network in that community. So 
our job is to try to identify what is the performance. And with 
our new grant that we are just starting this year, we will 
have, for the first time ever, a performance-based approach to 
measuring what is working, what is not working, not to blame or 
name or shame, but for us to say there is a problem here, this 
place is not able to perform this level of preparedness, it is 
CDC's job to go in and diagnose the problem and offer treatment 
and assistance and technical support.
    So I can't show you the results of the performance-based 
approach yet because we are just at the very beginning phases 
of it, but I think this is going to help you and this committee 
and others at the State and local level understand what is 
going well, what isn't going well, where should we 
preprioritize, but also get those lessons learned to move 
outside of the jurisdiction.
    I think we made a mistake in some of these areas of 
investing in some things 50 times. There were some things that 
probably could have done better in a regional or centralized 
manner with less investment and more expeditious dissemination, 
and we are trying to find those things and reallocate those 
investments in ways that are more helpful so that the local and 
state governments can concentrate on the things that are 
uniquely problematic for them, or where unique local and state 
solutions are imperative.
    It is a tremendous compendium of progress, but it is also a 
very sobering reflection of where we need to go next.
    Ms. Harman. Any other answers? My time is just about up, 
but I appreciate it.
    General Schoomaker. I will just make one comment.
    For most of what we talked about today, the Department of 
Defense and my command is in support of main efforts that our 
interagency partners obviously are leading in. But in this one 
regard of public health, it should be important to remind 
people that the Department of Defense has responsibility for 
8.6 million beneficiaries of healthcare, both as Soldiers, 
Sailors, Airmen, Marines, and Coast Guard, but also their 
families and retirees. And we are making every effort that you 
have heard here today to do real-time surveillance to look out 
for the public health.
    And I think in the last decade we have made tremendous 
inroads by substituting, just as military does, we have an 
expression we substitute knowledge for mass on the battlefield, 
and we are substituting knowledge for mass on the battlefield 
of public health as well through the electronic medical record, 
rapid information exchange, and the like.
    Ms. Harman. Thank you. Thank you, Mr. Chairman.
    Mr. Linder. The gentlelady from the District of Columbia, 
you are recognized for 5 minutes.
    Ms. Norton. Thank you very much, Mr. Chairman.
    Dr. Fauci, you spoke, I think appropriately, of being 
prepared for the obvious threats first. We know there are all 
kinds of next generation threats BioShield will have to deal 
with and the rest. I am very concerned about obvious threats. 
Of course, this is a city that had to deal with large numbers 
of people who were threatened with and died from anthrax, where 
this very campus was the central focus of the only large-scale 
attack of its kind in our country.
    I draw some comfort from knowing--I learned even at another 
hearing--of the work being done on anthrax. My concern, very 
frankly, is whether we are really--are we getting ahead of 
ourselves? We, in another committee, for example, had to deal 
with--Dr. Gerberding knows about this, the shortage of flu 
vaccine. This is a matter we have lived with for decades. You 
talk about being unprepared, the notion of being unprepared for 
something as obvious as what to do if something goes down, that 
happened to us in the flu vaccine. It did not inspire my 
confidence, as I sat in yet another committee and thought, 
really not about the flu, but thought about BioShield, about 
anthrax, about smallpox.
    I want to ask two questions, one goes to anthrax. You 
mentioned, Dr. Fauci, obvious threats, and the other goes to 
smallpox. I want to know whether or not, with the drugs you 
have now, given the fact that we have already had an anthrax 
attack, whether you believe we would be prepared to disseminate 
drugs and deal with an anthrax attack. Particularly, I am 
interested in closed areas, such as the Metro.
    Then I want to ask about smallpox. Who can forget the 
brouhaha with which the administration announced that, 
beginning with health care workers, we are going to make sure 
that people were vaccined against smallpox, it was a very real 
danger, big announcement. I never saw anything stop in its 
tracks more quickly than that, I can't find traces of what is 
happening. I need to know about that because in your testimony, 
Dr. Fauci, you talk about increases in the usable smallpox 
vaccines since 2001, aggressive acquisition program, more than 
300 million doses.
    Now we have got all these doses, there was this huge 
announcement by the administration of a program, what is the 
use of getting doses, announcing a program, and at least I 
can't find the link between what you say now exists and the 
program that was announced a couple of years ago. So I would 
like to ask about those two obvious threats, and how close we 
are to being able to do something about them in an event of an 
attack--not a futuristic attack, not a next generation attack, 
but perhaps the most obvious threat that we face today.
    Dr. Fauci. Thank you, Ms. Norton, and I will try to address 
that, and I think it is important to distinguish between 
smallpox vaccine that is available in anticipation of an event 
in which you try to get a certain relative proportion of 
individuals who might be first responders vaccined.
    You recall correctly that what the Department had 
originally put out was a goal that we did not reach, but a 
degree--
    Ms. Norton. We never got past the first responders, in 
fact, we never got through the first responders.
    Dr. Fauci. Right. And Dr. Gerberding will answer that 
aspect of it. But before I hand it over to her, I just want to 
mention that when you think in terms of having doses available, 
were there a disseminated smallpox attack, you would likely 
have not seen any reluctance of people getting vaccined, which 
gets to the research point of the modified vaccinia Ankara. The 
next-generation smallpox vaccine , which thus far was 
considerably experienced in safety, has very few, if any, 
adverse events associated with that.
    So what we are doing, as I mentioned in my statement, we 
are moving to get stores of that, as the next generation, at 
the same time having enough smallpox vaccine in the strategic 
national stockpile, were there an event to be able to vaccinate 
everybody.
    The response of preparedness I will hand over to Dr. 
Gerberding.
    Dr. Gerberding. Thank you. I will try to be quick on this.
    If you remember the smallpox preparedness program, it 
wasn't just about vaccinating people, it was about getting 
laboratories able to diagnose, it was about educating several 
million clinicians on how to detect a case, and several other 
elements of preparedness that were quite successfully achieved. 
One of the lessons that we learned from that is that when you 
are dealing with something that is at low but not zero risk, 
but really high consequence, you have to help people understand 
more effectively what is the rationale for it. Why would we 
invest--and particularly in this case, when our very careful 
monitoring determined some risks from this vaccine that had 
never been picked up before, despite all the decades that we 
used it to protect our kids in the past.
    So when you are engaging in the Pre-event Immunization 
Program that has hazards, the balance has to be very carefully 
articulated, and I think we could have improved our ability of 
engaging clinicians in the public in this process before we 
went forward.
    We immunized almost 50,000 people. Since that time, we have 
invested about $37 million in key cities, including the 
District, to try to make sure if we had a smallpox attack, we 
have a system that can get that vaccine that is in your 
stockpile to the arms of the people within 48 hours, and that 
is what we are working on right now. D.C. is not there yet, I 
can tell you right now, but we are working very hard with these 
investments. CDC just assigned a senior manager to the health 
department in Washington, D.C. to help improve our ability to 
handle our--
    Ms. Norton. When do you envision you will start again to 
try to enlist first responders, nurses, doctors and the like?
    Dr. Gerberding. Each community, including the District, 
makes its own decisions about what is the plan for 
administering vaccines, how many people need to be vaccinated, 
who should they be, and it is really their decision based on 
their distribution plan in the community, how many pre-event, 
how many during event and how many post event.
    The Secretary and all of us in the Department right now are 
working on plans to augment our ability to do that so that the 
Federal Government can help and not expect each community to 
carry the full burden.
    Ms. Norton. I thank you, Mr. Chairman.
    I just want to say that if you think that local 
jurisdictions on their own are going to proceed, even given the 
educational effort, without considerable prodding from the 
Federal Government to go ahead, if you think they should be 
ready now, I am here to tell you that I think without some 
reassurance from you at CDC that now is the time to go ahead, 
this program is not going to start--
    Dr. Gerberding. No, I agree with you. That is part of the 
investment and the reason we are putting the money there 
because we think that sends a message which is important. That 
is why we have performance measures so that we can verify 
whether performance has improved. And it is why, in the case of 
the D.C. area, we are specifically assigning one of our best 
managers to come in locally and really help get this on the 
road because we recognize this is a high threat community.
    But I agree with you completely. We can't sit in Atlanta 
and Washington and make pronouncements, we have to get out 
there--
    Ms. Norton. Nor can you say that each local jurisdiction go 
ahead when you want to; you have to push it.
    Mr. Linder. The time of the gentlelady is expired.
    Mr. Markey is recognized for 5 minutes.
    Mr. Markey. Thank you, Mr. Chairman. Welcome.
    In April of 2005, I wrote to both CDC and the Department of 
Homeland Security about the accidental shipment of the H2N2 flu 
virus to thousands of laboratories and health care facilities. 
The H2N2 virus was the flu virus that caused the worldwide flu 
epidemic, pandemic that killed 1 million to 4 million people 
between 1957 and 1958.
    While all the samples have reportedly been accounted for, 
the responses provided by CDC and DHS raised some serious 
questions regarding both policy and the degree to which CDC and 
DHS are coordinating their efforts.
    When I asked the Department of Homeland Security whether 
the H2N2 flu samples could be used as a biological weapon, the 
Department of Homeland Security stated that ``if these 
materials fell into the hands of terrorists, they could be used 
as a biological weapon.'' When I asked the Department of 
Homeland Security whether they had evaluated their laboratories 
and screened the individuals that have access to this virus, 
DHS stated that this job belonged to the CDC select agent 
program, the program for Ebola, the program for the most 
serious virus.
    But CDC's response to my question stated that CDC decided 
not to include the H2N2 flu strain on the select agent list in 
the first place.
    My first question, Dr. Gerberding, do you agree with the 
Department of Homeland Security's conclusion that H2N2 could be 
used as a biological weapon?
    Dr. Gerberding. Our opinion is that virtually any 
infectious disease could be used as a biological weapon. 
Influenza was not on the select agent list, that was a decision 
made by a group of experts who were looking at not just can 
something cause disease, but can it be weaponized and does it 
meet the other criteria--
    Mr. Markey. What was your conclusion?
    Dr. Gerberding. The conclusion at that time was not. One of 
the things that is not commonly recognized about H2N2 is that 
the H2 is new, but the N2 is something that we have been 
experiencing for the last several years. So, in fact, the true 
threat associated with that particular experience was probably 
not nearly as great as we had been describing in our 
anticipation of making sure that we absolutely had recovered it 
because we have population immunity to the N2 component.
    Mr. Markey. When the CDC is evaluating whether to include 
something on the select agent list, is potential use as a 
biological weapon considered?
    Dr. Gerberding. CDC does not make the decision about what 
is on the select agent list, that is a decision that is made by 
an interagency working group of the Federal Government, which 
includes the U.S. Department of Agriculture and NIH and the 
CDC--
    Mr. Markey. When the CDC is making its recommendation, does 
it include as part of its recommendation whether or not it can 
be used as a biological weapon?
    Dr. Gerberding. That is the criteria for a select agent.
    Mr. Markey. So is there a disagreement between the 
Department of Homeland Security and CDC on its inclusion?
    Dr. Gerberding. I would defer to Dr. Vitko, because I don't 
know what the Homeland Security position was on that committee.
    Mr. Vitko. I wasn't around for the committee. The point is, 
we believe that--I don't have the detailed response that you 
have in your hand--but I believe there is another paragraph on 
there that also states that it is a question of quantity and 
the way it is released, so yes.
    Mr. Markey. Well, in the Department of Homeland Security 
response to my letter on the H2N2 virus, the Department of 
Homeland Security repeatedly stated that the CDC Select Agent 
Office was responsible for monitoring those who have access to 
the virus and other matters. Did you know that H2N2 wasn't even 
on the select agent list in the first place? And if so, why did 
your agency continually refer me to the office in charge of 
regulating the select agents back at CDC?
    Mr. Vitko. It must have been an error.
    Mr. Markey. Well, it appears that there is a regulatory 
black hole that sits right in the middle of these agencies on 
this issue, that is, that on something that is so contemporary, 
this flu virus, and so potentially dangerous if it could be 
used, that there should be, at this point, given the fact that 
it is now 4 months since I wrote the letter, that some kind of 
a resolution of the issue was reached, and some kind of 
coordination that was established between Homeland Security and 
CDC over a subject where there appears to be a difference of 
opinion in terms of how this agent could be used on 
bioterrorist organization.
    Dr. Gerberding. I can't speak for what was in the Homeland 
Security letter, but the process that Congress has defined for 
us in making these decisions is to, first of all, make a 
determination that a pathogen belongs to a select agent list 
using a set of criteria. Once an agent is on the list, it is 
CDC's job to do the appropriate steps to assure that people who 
are using that agent have security clearance and are using the 
appropriate containment procedures in their laboratory. So had 
this virus been on that list, CDC would have been responsible 
for the laboratories that were used it as a--
    Mr. Markey. I understand that, but getting it on the list 
now is obviously something that is difficult to comprehend 
because of this regulatory black hole that exists. For example, 
the Bird Flu Virus, or SARS, or any other highly infectious 
virus, have they been added to the being select agent list?
    Dr. Gerberding. Highly pathogenic avian influenza viruses 
are on the select agent list as defined by the USDA list of 
select agents.
    Mr. Markey. They are on the select agents.
    Dr. Gerberding. The viruses that are capable of causing 
pandemics and fall into the avian group are on the list.
    Mr. Markey. Have you solicited the Department of Homeland 
Security's views on whether these viruses--
    Dr. Gerberding. The Department of Homeland Security is 
represented on an expert committee that makes the 
determination, as are the other Federal agencies that have a 
stake on this.
    Mr. Markey Thank you.
    Mr. Linder. We would like to get a few more questions, if 
the panel can stay around for a few more questions. I think we 
will vote in about 15 minutes. I just have a couple of 
questions.
    Going back to the labs, how many level 4 labs are there in 
the country?
    Mr. Vitko. Level 4 labs in the country? I actually don't 
have that answer. I will defer to Dr. Fauci on that. We did a 
survey on 3 and 4, we issued a biocontainment report in which 
there are several hundred at the 3 or 4 level, but only a dozen 
or so at the level 4 level. Not even that, less than that.
    Mr. Linder. Are we building more?
    Dr. Fauci. Currently there is the CDC, there is the BSL4 at 
USAMRIID. There is a BSL4 in Galveston. So those are three. 
There is one that is being constructed at Rocky Mountain Labs 
in Hamilton, Montana. There is one that is being constructed at 
Fort Detrick at the NIH in conjunction with the United States 
Army. And then there are planned BSL4s, one in Galveston and 
one in Boston, and they have not begun yet. The one in 
Galveston just broke ground in May of 2005, the one in Boston 
is scheduled to break ground in December of 2005.
    Mr. Linder. But at what point do we build enough labs that 
they start to cannibalize the other labs they have because of 
limited scientific knowledge we have in this country.
    Dr. Fauci. I am sorry?
    Mr. Linder. At what point do we begin to cannibalize the 
other labs that currently exist because of the limited number 
of scientists at this level in the country?
    Dr. Fauci. You say the other laboratories--
    Mr. Linder. New labs will wind up taking scientists from 
the old labs.
    Dr. Fauci. Yes, okay. I understand. I didn't quite get it 
the first time, I apologize.
    The question is a reasonable question. If you have 
scientists that are involved in biodefense, are you drawing 
them out from other areas of research that are important to the 
Nation? And the answer is, whenever you are gearing up in a new 
area that requires scientific expertise, certainly there is a 
draw off to some extent. But in other experiences we have had, 
such as with HIV/AIDS in which we had to draw from the 
microbiological and infectious diseases community, it really 
turns out that it normalizes reasonably quickly, where you get 
more people involved in a field, and although initially there 
may be some drawing off of people who would otherwise have been 
working on something else and now working on biodefense, at the 
end of the day it tends to equalize itself because you get 
quantitatively more people in the field as opposed to just 
diverting from one to the other.
    So there is the initial component of what you are talking 
about, but what we hope to do is enhance the amount of 
intellectual capital involved in all emerging and reemerging 
infectious diseases with the ability to go back and forth 
between deliberately emerged or bioterror agents or agents that 
we absolutely still need more people for where they are 
naturally occurring.
    General Schoomaker. It might also be worth just clarifying 
that a BSL4 lab is not necessarily a BSL4 lab, there are 
distinctions within the community of BSL4s that have expertise 
and capacities. For example, aerosolized testing evaluation, 
that is a subset of BSL4. So it sounds highly redundant, or 
maybe competing with one another, but there are specialties and 
specialization within the BSL4.
    Mr. Linder. Dr. Gerberding, in a private conversation you 
and I had we talked about sources of intelligence around the 
world, and you mentioned the use of some of these international 
corporations. I would like you to expand on that for the record 
and for this committee.
    Dr. Gerberding. I think that what we are talking about is 
making use of any available information, particularly in the 
areas that don't have robust public health systems or don't 
have data systems that allow health information or event 
information to come in through traditional means. The United 
States Government has a large stake in the health status of 
these areas because we have workers and citizens and businesses 
that are operational there. People on the business sector have 
a stake in the health of their workers and in the health of the 
communities in which they are working.
    So it is very possible that there are health events that 
could unfold in an area where the business community may be the 
first to recognize that there is a problem, and might be in a 
position to give us a heads-up or to give the local minister of 
health a heads-up that there is something amiss in the 
community.
    We have no proof that this is a successful strategy, but we 
have strong interests on the parts of several corporations to 
think about, is there a way that this kind of shared interest 
in health status, not just terrorism, but any kind of health 
event could benefit the community, could help be an element of 
protection for the business and could serve as another input or 
a resource for information here. It is a little bit like the 
open source method of mining things that appear on the Internet 
or reading local reports in newspapers and the local press 
about things unfolding at the community level.
    Again, I have no proof that this is going to be successful, 
but it is something that we want to explore carefully because 
we certainly don't want to compromise the business interest or 
send a message to their customers in that region of the world 
that they are there for anything other than business purposes. 
But we live in a global community, and there are potential 
situations where this could be a win-win for all parties 
concerned.
    Mr. Linder. Mr. Langevin.
    Mr. Langevin. Thank you, Mr. Chairman.
    If I could, I know Dr. Christensen touched on this, but so 
I have a more clear understanding, Dr. Fauci, the work that you 
do at NIH and the work that is done at CDC, who does what? Is 
there a duplication of effort between NIH and CDC in this 
respect?
    Dr. Fauci. No, there is not, Mr. Langevin. There is a 
certain degree of complementarity, but there certainly is not a 
duplication of efforts at all. In fact, we very closely 
coordinate what we do on a real-time basis almost constantly, 
so I really cannot think of any examples at all where there is 
duplication without a purpose of complementary nature to it.
    Dr. Gerberding. I couldn't agree more. I feel that we have 
a collaborative relationship. Dr. Fauci and I are often at the 
witness table together for that very reason. But one very 
specific example is that some joint research proposals that CDC 
had a small amount of extra research money that Dr. Fauci's 
institute embedded in their larger research portfolio, so when 
the investigator applied for bioterrorism infectious resources, 
it was an NIH grant, but the CDC got some of its priority work 
done through their mechanism. So we think that is a good model 
for demonstrating that we are collaborating and not redundant, 
and at the same time the investigators who cue up to apply for 
these resources have the imprimatur of an NIH grant. So it is a 
win-win.
    Mr. Langevin. That is good to hear.
    Now, one of the stated goals of HSPD-10 is decontamination 
recovery from a chemical or biological attack. Who is the lead 
agency on this, and how is it done? And what types of attacks 
do you feel that we can successfully decontaminate right now?
    And related to this is the issue of quarantining, and what 
authority do we have to quarantine and who has the ultimate 
authority on that kind of activity?
    Mr. Vitko. The HSPD-10 in the section on response and 
recovery gives EPA the overall lead for determining the 
decontamination technology standard and systems approaches to 
the cleanup.
    In the section on prevention and protection in the critical 
infrastructures, it lists DHS as the lead for decontamination 
methodologies for critical infrastructures. So those are the 
two agencies, with the EPA having an overall responsibility.
    Mr. Langevin. And another question. Last winter we 
experienced a great shortage of flu vaccine which clearly 
demonstrated a weakness in our public health practices, namely 
that we rely too heavily on one flu vaccine maker. Do you have 
sufficient flu vaccine to inoculate the public this coming 
winter? And on a related point, are there lessons learned from 
this that you will find useful in procurement of other 
vaccines?
    Dr. Gerberding. Let me first say many lessons were learned, 
I think, by FDA, CDC and NIH and the rest of the stakeholders 
in last year's flu vaccine shortage. We will not know how many 
doses of flu vaccine we have until the season is completed 
because the manufacturing process starts imminently and the 
vaccine rolls off the assembly line throughout the season. If 
everything goes well, we will have the expected supply from 
Sanofi Pasteur. We are hoping Chiron will be able to resume 
their production, although, again, until they actually start 
producing vaccine, we are not counting on it.
    Dr. Gerberding. And we are still working on the 
international sources. We expect a third manufacturer to be 
newly licensed this year for sales in the United States in time 
for flu season.
    But the lesson we learned, I think the biggest lesson 
overall is, don't count your chickens until they are hatched. 
And so we are not planning to blast out at the beginning of the 
season with optimism that all of these sources will come 
through as we are expecting. We are going to emphasize 
immunization of the high-risk groups first so that we are sure 
the people who need the protection the most don't have to stand 
in line to receive it.
    Mr. Langevin. I see my time has about expired, so I yield 
back.
    Mr. Linder. Mr. Shays.
    Mr. Shays. Thank you, Mr. Chairman. And thank you all for 
staying for additional time. Mr. Chairman, if this had been my 
committee, they would have been here at 10:00, still here, so 
don't spoil them, because we are learning so much.
    You are an awesome panel. You are very articulate and you 
are very helpful. And I agree with my colleague Ms. Jane Harman 
that it gives me some comfort to know you are doing what you 
are doing.
    I had asked the question about what is in the refrigerators 
in the Soviet Union, the stuff that they are working on. I have 
seen it. They have strings with wax attached, very poor 
security, and so on.
    But forget them for a second. I would like you to comment--
and since I would like to ask a few questions, if you all 
agree, then we will just go to the next question. But the 
question I have is, should we be concerned about some of the 
viruses, pathogens, whatever that may be in research labs, 
locked up, not properly identified in colleges and so on?
    Dr. Gerberding. I am concerned. I think that the academic 
culture traditionally has been very open, very collegial, and 
very focused on research. And we are asking for somewhat of a 
culture change. We are asking our academic partners to be 
mindful of the fact that some of the agents that they are 
working with are potentially threat agents or, in the wrong 
hands, could be used or developed as a threat agent, as part of 
the importance of the select agent process, so that people who 
are working with the select agents are registered, inspected, 
and their security background is checked.
    It is not a fail-safe system. And, you know, the trust that 
has been built up over many, many years of successful 
engagement in these infectious disease research activities--and 
I should say, probably also applies to chem and biothreats in a 
different realm--is one that has worked very, very well when 
you consider the possibilities. But we need to have a stronger 
network now. And it is not 100 percent known what is in the 
freezer.
    Mr. Shays. Does anyone disagree with the answer there?
    Dr. Fauci. Agree, and that the National Science Advisory 
Board for BioDefense is trying to create just what Dr. 
Gerberding said, that culture of responsibility among the 
people who might have these agents.
    Mr. Shays. The culture is important, but do we have laws 
that back it up? Can people be sent to jail if they don't 
properly label and secure these vaccines?
    Dr. Gerberding. Absolutely. That is the purpose of the 
select agent process. There is the law enforcement component to 
that through the Department of Justice.
    Mr. Shays. Just as briefly as you can, give me some 
comfort, in addition to what you said so far, that we are 
utilizing the resources that are already available at every 
hospital that takes in patients. How good is the network, not 
of new--you know, just within the existing facilities? Does 
every hospital in every State have to file information every 
day to a centralized location in the State? And then do you 
have access every day on, you know, a ``now'' basis to get that 
information?
    Dr. Gerberding. No. The only information we currently get 
from the health care delivery system every day is what we get 
from the Department of Defense and the VA. But we will, through 
the Secretary's health information technology initiative, which 
is a major, major, major priority of our administration. As 
electronic medical records become available we are creating 
opportunities to have the de-identified information of public 
health interest automatically forwarded to CDC through our 
biosense mechanisms so that we have that real-time, everywhere, 
everybody, everyday kind of access to health events in our 
communities.
    Mr. Shays. General, you want to answer, but let me make 
sure that you incorporate some kind of answer as to whether 
there are deadlines.
    General.
    General Schoomaker. Sir, I just want to add to that I think 
we are in our relative infancy in this, the connectivity of the 
different elements of the health care delivery system. The 
Department of Defense has shared its expertise and its 
technology with the CDC and continues to do that. We use a 
program based on syndromic events, that is, the recognition of 
syndromes that are associated with known agents that are 
infectious illnesses, but that I think we would all agree right 
now is still again in its infancy. It is wired in with Johns 
Hopkins University in a program called essence. There are 
improvements coming, and are forthcoming right now.
    Mr. Shays. When do you think we are going to see a system 
thatSec.  just, we have instant data from almost every 
hospital, health care center? When we will have such a system?
    Dr. Gerberding. For the most useful information, I would 
say we are in a 5-year horizon for being able to do that 
ubiquitously. By the end of this year, we will have that 
information from critical hospitals in most of our major 
cities; and by the end of next year, we will have it from all 
of the hospitals in those major cities.
    Mr. Shays. Fairly instant data? I am sorry.
    Dr. Gerberding. Real-time data. As the transaction occurs 
in the ER, it will be appearing in our system.
    Mr. Shays. Thank you.
    Mr. Linder. Dr. Christensen.
    Mrs. Christensen. Thank you. I think I am going to try to 
follow my colleague Mr. Jindal's lead. I am going to try to get 
a couple questions in.
    One, where does the new chief medical officer of the 
Department of Homeland Security fit into all of this?
    Two, I am glad to hear about some of the research, Dr. 
Fauci, on the agents with broad application. But we had a 
hearing where we heard of some others that seemed to be very 
promising and would be worthwhile considering, such as those 
that treat radiation sickness or stop bleeding. And I wanted to 
know maybe from Dr. Vitko, how do you get them entered into 
consideration and maybe into the stockpile?
    And Dr. Gerberding, just the cuts in your budget, I am 
still concerned that we are going to find that some of the core 
functions, the infrastructure that has to be there every day, 
is going to suffer while we have the demands on CDC to deal 
with bioterrorism.
    Mr. Vitko. Okay. I will begin with answering the question 
on the chief medical officer.
    As you heard from me, the portion that I represent in S&T 
is the bioportfolio that basically does the research and 
development aspects, but we have very little operational 
responsibility. The chief medical officer will come in and have 
overall responsibility for being the medical interface with the 
other agencies, with HHS, USDA. DHS does have some operational 
assets in that sense in the National Disaster Medical System 
and in the medical--Metropolitan Medical Response System and in 
coordinating those kinds of activities. So the chief medical 
officer will be the overall interface for the agencies.
    Dr. Fauci. Countermeasures such as those for radiation 
sickness. We just completed our strategic plan and research 
agenda for radiation, for the money that is coming from the 
Department in 2005, $47 million. A very high priority is how 
one treats radiation exposure, and in fact, we have been in 
communication with the company that I believe you are referring 
to.
    Mr. Vitko. And we have done the material threat assessments 
on both the radiological devices and a special study on nuclear 
weapons, fissile weapons, used in that kind of context, and 
provided that to the WMD medical countermeasures committee, and 
they are using that in their requirements process.
    Dr. Gerberding. And with respect to the proposed 2006 
budget for CDC, our overall preparedness budget has actually 
increased in the proposed budget. What has been cut from our 
budget are some very specific programs. The House mark and the 
Senate mark, of course, are not resolved yet, so we are not 
really clear where that budget will ultimately reside.
    While I think every agency head at this table and any other 
table would always think of good ways to use budget increases, 
we also can do a lot with the budget that we have, and we have 
got to make every one of these preparedness dollars go as far 
as we can. That is why we are putting emphasis on the 
performance-based investments this year, so we know what we are 
getting and where we need to either invest more or do more to 
get that network seamless.
    Mr. Linder. Mr. Simmons.
    Mr. Simmons. Thank you, Mr. Chairman.
    And, again, thanks to the panel. A quick question focusing 
on Dr. Vitko's testimony.
    Pages 7 and 8, he refers to the Plum Island Animal Disease 
Center. The Plum Island Animal Disease Center is located in New 
York on Plum Island in Long Island Sound, but most of its 
professional personnel actually reside in Connecticut and go 
out to the facility on a daily basis by ferry boat--well, all 
working days of the year and all working weeks--under all sorts 
of interesting and challenging conditions.
    I understand from your testimony that there is a 
recapitalization program under way for a next-generation 
facility, the National Bio and Agro Defense Facility. It 
doesn't indicate in your testimony whether this facility is 
planned as an upgrade to Plum Island or for some other 
location. And ever since Plum Island left USDA and went into 
Homeland Security, there were rumors that it might close and 
those activities might be moved elsewhere.
    The facility is not a new facility from the standpoint of 
its installation; it has been around, I think, for 50 or 60 
years. But, in fact, investments have been made; I have been 
out to the island several times, and it is relatively modern in 
many of its aspects.
    My question is, in the planning for the upgrades, is that 
for Plum Island or is that for some other location?
    Mr. Vitko. And the answer is, the siting decisions haven't 
been made on it yet. We are first formulating the programmatic 
requirements of what we want to accomplish, see whether it can 
be accomplished within the existing footprint and traded off, 
and look at other options.
    Mr. Simmons. And when might we be brought up to date on 
some of those activities?
    Mr. Vitko. The conceptual design studies that are 
formulating those program requirements are just now being 
initiated, and somewhere in mid-2006 we should have the 
programmatic requirements and the pros and cons of different 
siting strategies available at that time.
    Mr. Simmons. Okay. I thank you for that. I mean, I will 
simply say that the people that I have met that work out there 
are highly qualified, very capable, an extraordinary asset and 
that, of course, relocating creates losses. And I hope the 
people doing the planning are aware of that.
    Mr. Vitko. We echo the fact that the Plum Island Animal 
Disease Center is making major contributions, has and continues 
to make major contributions; the personnel are excellent. And 
we are making progress; right now, even within the existing 
footprint, we are constrained with the space that we have there 
about how much progress we can make on foreign animal diseases 
just because of the facilities. It is possible that it could be 
expanded there; it is possible that we will need to look 
elsewhere. Those are the options that are on the table.
    Mr. Simmons. I thank the panel. And I thank the chairman 
for going for the second round.
    Mr. Linder. We have a 15-minute vote starting. Ms. Norton, 
we still have time for your questions.
    Ms. Norton. Thank you very much, Mr. Chairman. I just have 
one question. This is a question for Dr. Gerberding. Again, it 
is anthrax, an obvious threat.
    I wrote you a letter in--several months ago after a false 
alarm here involving what you may remember to be postal 
facilities in Virginia where they thought there was an anthrax 
attack. I learned for the first time that my own first 
responders and first responders throughout this region are 
using biological field detection nonlaboratory equipment.
    I have not received a response to this letter. If I could 
just say to all you, when a Member of Congress writes, you just 
well answer, because any good member will cite this to you as 
part of her questions. And it is not a very good thing not to 
answer when some--if you don't know the answer, tell them.
    I was really concerned because I found these things being 
used all around. And I said, Well, you get this thing. Who 
regulates these things? Which ones are good? Which ones are 
bad? And I learned after making some inquiries that nobody does 
anything, they just go out and get them if you don't--people 
don't do what they have to do if the government doesn't give 
them any guidance.
    Now, I learned, however, that you had--you, CDC, had given 
some recommendations to the U.S. Postal Service--of course, 
perhaps, in light of the fact that they had suffered an attack 
once--on the use of these autonomous handheld devices. I don't 
know that the devices were good or bad during this or had 
anything to do, frankly, with this false alarm. What I do know, 
or have learned since, is that they are being used throughout 
the country.
    We know that, of course, your certified laboratory response 
network is the only way to know if there has been an anthrax 
attack. But so do these people know that; and they said to me, 
Well, in coordination with them--and we will always send it to 
them anyway--we are going to use these things.
    Disturbingly, Dr. Kati Kelley, who is now the President of 
the Association of Public Health Laboratories, testified before 
the Government Reform Committee--and I am quoting here, and I 
did in my letter--``CDC's minimal supply of materials to allow 
testing''--she talked about her concerns about CDC's minimal 
supply of materials to allow testing for biological terrorism 
substances. She said that you simply didn't have the--there was 
a shortage of the critical testing kits at CDC.
    I asked about that, and I asked whether you could do 
something about the proliferation of these handheld devices. I 
am not suggesting that they are good or bad. I am suggesting 
that if the government sits back and says--and here, in this 
case, you actually recommended against the use of these 
biological field detection autonomous nonlaboratory equipment; 
if you are going to recommend against it and if you were not a 
regulatory agency that is going to offer no guidance and they 
are going to proliferate, leaving it to the wonderful free 
market sector, when they don't hear you saying anything, they 
just all produce whatever ones they want to and they market to 
our first responders, then I am left to ask, Well, who in the 
world will--and help us out here.
    If it wasn't for you to do, particularly after I wrote 
directly to you April 29, I don't know why--perhaps it was Mr. 
Vitko--this stands unanswered. And more seriously unanswered is 
the opinion or the view expressed to the Government Reform 
Committee in April that you, yourself, are very short of 
critical testing kits, which leaves me wondering what would 
happen here if we had another attack and all we had were these 
hand-held devices which nobody has tested or given any guidance 
or any recommendations concerning.
    So I would like to know those two things: Whether you 
yourself could handle someone sending to you directly from, let 
us say, various parts of the country, particularly in the event 
of a simultaneous attack. And why you haven't given some 
guidance yourself or gone to whoever you think is appropriate 
to offer guidance.
    And, finally, why didn't you answer my letter?
    Dr. Gerberding. Ms. Norton, I can see that people are 
getting ready to vote, so let me try to get the most important.
    Ms. Norton. I don't have to vote.
    Dr. Gerberding. I am trying to answer what I think is your 
most important question. I apologize for being nonresponsive to 
your letter; I will look into why that happened. We generally 
have a good track record of response, as we take congressional 
letters very seriously; and I am personally very sorry that you 
didn't get good customer service from CDC on this issue.
    With respect to the shortage of reagents for the last--I 
can assure you that, first of all, that played absolutely no 
role in the situation in the postal facilities here. We do not 
have a current shortage, but we are worried that we are able to 
keep up the supply as reagents expire over time. So the planned 
request in our 2006 budget appropriation is to correct that. 
And assuming that our budget is, as we anticipate from the 
current marks in the House and the Senate, we will have the 
resources we need to deal with the reagent issues in the future 
at CDC.
    So that is not a current issue across the United States; it 
is a predicted issue if we didn't take steps to fix it in the 
future.
    With respect to what the Postal Service is doing to monitor 
the quality of the air in the postal facilities, I can assure 
you that the USPS has used an extremely thoughtful process. 
They have evaluated these systems very carefully. And I believe 
it is the Department of Homeland Security that they are working 
with.
    There are three sets of these systems in major play that we 
can talk about comfortably in public. There are some other 
applications that would best be discussed out of the public 
record. One is the BioWatch system that you have heard about in 
our cities; one is the system in play in our postal facilities, 
at the decision of the U.S. Postal Service with consultation 
from DHS and CDC; and a third is the system that I believe the 
military is using in certain applications that I again don't 
want to--
    Ms. Norton. I am talking about handheld devices. Are you 
talking about?
    Dr. Gerberding. I am talking about the circumstances of the 
scenario that you are describing these past several months. 
With respect to handheld or so-called ``smart ticket'' types of 
devices, that is an area where CDC explicitly has recommended 
against their use, other than for ruling out a true positive, 
because they are not specific. They are very often misused; we 
have had numerous false positives with them.
    Ms. Norton. They say it is an extra layer and they are 
going to send it to you anyway. And they want to use them.
    You may be right. What bothers me is, nobody tells--they 
are buying them because you don't give them any guidance one 
way or the other.
    Dr. Gerberding. I would disagree. We do provide guidance to 
the Postal Service.
    Mr. Linder. The time of the gentlelady has expired.
    Mr. Vitko. Let me also join the answer, if I may.
    First of all, CDC has provided that guidance advising 
against them. Second of all, DHS sponsored jointly with NIST a 
test of handheld devices, specifically around anthrax testing 
the ``smart tickets,'' in which five companies participated, 
independently run by the American Association of Analytical 
Chemists, that were done explicitly for this purpose, to 
provide an independent evaluation of the product to see whether 
it could perform--and these handheld detectors might be useful 
against powders, not against testing surface contamination or 
hemispheric contamination, but against powders--and to test 
their validity.
    And the test results of that are available. And so a 
process has been set up with an independent third-party agency, 
this respected testing agency to do that.
    Third is, I mentioned to you that these joint five agencies 
have joined on this coordinated biomonitoring memorandum of 
understanding, and part of that, they are establishing 
equivalency processes. And we have also begun a discussion with 
industry for an approach to make available for them the high 
accuracy--more importantly, high specificity--assays.
    The real issue with the handheld assays or with anything 
that you use in a commercial device is, does it have the 
specificity to say that this is a threat and not light up on 
everything else and start the whole system ringing? And we are 
in the process of working that with the--there is an industry 
consortium called the--
    Mr. Linder. Dr. Vitko, I actually do have to vote. And if 
you have more to say to her, you can send her a letter. I want 
to thank our witnesses for their expert testimony. It has been 
very, very helpful. This is new ground for us, and we are 
grateful.
    And, without objection, the hearing is adjourned.
    [Whereupon, at 4:18 p.m., the subcommittee was adjourned.]

                             For the Record
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