[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]


 
                 TOWARDS A NATIONAL BIODEFENSE STRATEGY

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

                                HEARING

                                 of the

                 SELECT COMMITTEE ON HOMELAND SECURITY
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                               __________

                              JUNE 3, 2004

                               __________

                           Serial No. 108-50

                               __________

    Printed for the use of the Select Committee on Homeland Security


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                 SELECT COMMITTEE ON HOMELAND SECURITY


                 Christopher Cox, California, Chairman

Jennifer Dunn, Washington            Jim Turner, Texas, Ranking Member
C.W. Bill Young, Florida             Bennie G. Thompson, Mississippi
Don Young, Alaska                    Loretta Sanchez, California
F. James Sensenbrenner, Jr.,         Edward J. Markey, Massachusetts
Wisconsin                            Norman D. Dicks, Washington
W.J. (Billy) Tauzin, Louisiana       Barney Frank, Massachusetts
David Dreier, California             Jane Harman, California
Duncan Hunter, California            Benjamin L. Cardin, Maryland
Harold Rogers, Kentucky              Louise McIntosh Slaughter, New 
Sherwood Boehlert, New York          York
Lamar S. Smith, Texas                Peter A. DeFazio, Oregon
Curt Weldon, Pennsylvania            Nita M. Lowey, New York
Christopher Shays, Connecticut       Robert E. Andrews, New Jersey
Porter J. Goss, Florida              Eleanor Holmes Norton, District of 
Dave Camp, Michigan                  Columbia
Lincoln Diaz-Balart, Florida         Zoe Lofgren, California
Bob Goodlatte, Virginia              Karen McCarthy, Missouri
Ernest J. Istook, Jr., Oklahoma      Sheila Jackson-Lee, Texas
Peter T. King, New York              Bill Pascrell, Jr., North Carolina
John Linder, Georgia                 Donna M. Christensen, U.S. Virgin 
John B. Shadegg, Arizona             Islands
Mark E. Souder, Indiana              Bob Etheridge, North Carolina
Mac Thornberry, Texas                Ken Lucas, Kentucky
Jim Gibbons, Nevada                  James R. Langevin, Rhode Island
Kay Granger, Texas                   Kendrick B. Meek, Florida
Pete Sessions, Texas
John E. Sweeney, New York

                      John Gannon, Chief of Staff

       Stephen DeVine, Deputy Staff Director and General Counsel

           Thomas Dilenge, Chief Counsel and Policy Director

               David H. Schanzer, Democrat Staff Director

             Mark T. Magee, Democrat Deputy Staff Director

                    Michael S. Twinchek, Chief Clerk

                                  (II)


                            C O N T E N T S

                              ----------                              
                                                                   Page

                               STATEMENTS

The Honorable Christopher Cox, a Representative in Congress From 
  the State of California, and Chairman, Select Committee on 
  Homeland Security..............................................     1
The Honorable Jim Turner, a Representative in Congress From the 
  State of Texas, and Ranking Member, Select Committee on 
  Homeland Security..............................................     3
The Honorable Dave Camp, a Representative in Congress From the 
  State of Michigan..............................................     5
The Honorable Donna M. Christensen, a Delegate in Congress From 
  the U.S. Virgin Islands........................................    25
The Honorable Norman D. Dicks, a Representative in Congress From 
  the State of Washington........................................    28
The Honorable Jennifer Dunn, a Representative in Congress From 
  the State of Washington........................................    32
The Honorable Bob Goodlatte, a Representative in Congress From 
  the State of Virginia..........................................    49
The Honorable James R. Langevin, a Representative in Congress 
  From the State of Rhode Island.................................    30
The Honorable Sheila Jackson-Lee, a Representative in Congress 
  From the State of Texas........................................    32
The Honorable Christopher Shays, a Representative in Congress 
  From the State of Connecticut..................................    22

                               WITNESSES
                                Panel I

The Honorable Penrose ``Parney'' Albright, Assistant Secretary 
  for Science and Technology, Department of Homeland Security
  Oral Statement.................................................     5
  Prepared Statement.............................................     8
Dr. Anthony Fauci, Director of the National Institute of Allergy 
  and Infectious Diseases Department of Health and Human Services
  Oral Statement.................................................    13
  Prepared Statement.............................................    16
Accompanied by: Dr. William F. Raub, Principal Deputy Assistant 
  Secretary, Office of the Assistant Secretary for Public Health 
  Emergency Preparedness
  Oral Statement.................................................    26
Major General Lester Martinez-Lopez, Commanding General, U.S. 
  Army Medical  Research  and  Materiel  Command, Fort  Detrick,  
  Maryland
  Oral Statement.................................................    12

                                Panel II

Dr. Shelley A. Hearne, Executive Director, Trust for the 
  America's Health
  Oral Statement.................................................    41
  Prepared Statement.............................................    43
Dr. Anna Johnson-Winegar, Private Consultant
  Oral Statement.................................................    37
  Prepared Statement.............................................    38

                                APPENDIX

Questions and Responses for the Record:
  The Honorable Penrose C. Albright..............................    57
  Dr. Anthony S. Fauci...........................................    80
  Dr. Shelley Hearne.............................................    64
  Major General Lester Martinex-Lopez............................    73
  Dr. Anna Johnson-Winegar.......................................    75


                 TOWARDS A NATIONAL BIODEFENSE STRATEGY

                              ----------                              


                         Thursday, June 3, 2004

                          House of Representatives,
                     Select Committee on Homeland Security,
                                                    Washington, DC.
    The committee met, pursuant to call, at 1:13 p.m., in Room 
345, Cannon House Office Building, Hon. Christopher Cox 
[chairman of the committee] presiding.
    Present: Representatives Cox, Dunn, Barton, Shays, Camp, 
Goodlatte, Linder, Thornberry, Turner, Dicks, Lowey, McCarthy, 
Jackson Lee, Christensen, Lucas, Langevin, and Meek.
    Chairman Cox. The Select Committee on Homeland Security 
will come to order. The committee is meeting today to hear 
testimony on the development of a national biodefense strategy. 
In order to allow us to hear from our witnesses more quickly, I 
would ask members to waive or limit the duration of oral 
opening statements. Those who are present within 5 minutes of 
the gavel and waive their opening statement will be allotted 3 
additional minutes for questioning the panel. If the members 
have written statements, they may be included in the hearing 
record.
    I want to thank our distinguished panelists for appearing 
before us this afternoon.
    The biothreat is particularly worrisome because we know so 
little about terrorist capabilities. We don't know nearly as 
much as we would like about their motivations and their 
intentions to employ biological weapons. Yet, we also know that 
a bioattack could result in a catastrophic loss of life. The 
Department of Homeland Security must have experienced analysts 
to assess the threat on a continuing basis, and must play a 
leading role in coordinating the development of antidotes and 
countermeasures to the most virulent agents we face today and 
that we will face tomorrow.
    As the President stated soon after 9/11, disease has long 
been the deadliest enemy of mankind. Infectious diseases make 
no distinctions among people and recognize no borders. We have 
fought the causes and consequences of disease throughout 
history, and must continue to do so with every available means. 
Of course, this goes triply if those diseases are being spread 
intentionally rather than by mother nature.
    Under President Bush's leadership, we have stood up the new 
Department of Homeland Security, substantially increasing 
biosecurity through the passage of the Bioterrorism 
Preparedness Act of 2002, and we have begun implementation of 
the latest Presidential directive on biosecurity, HSPD-10. We 
have also dramatically increased funding for biodefense 
research, surveillance, preparedness, and response activities.
    The House and now the Senate have also passed the project 
BioShield Act, which hopefully soon will go to the President's 
desk for signature. This bipartisan legislation is an 
investment to incentivize development of the counter-measures 
by the private sector and speed up biodefense research. It is 
only one of many initiatives the President has proposed and 
fully supported to counter the continued biothreat.
    The serious and continuing threat to our citizens is real. 
The President's and Congress' commitment to reducing it is 
today greater than ever. The good news is that our investments 
in biodefense will have significant application to naturally-
occurring infectious diseases that can, with little warning, 
wreak havoc on mankind without regard to borders or social 
class.
    The science and technology revolution in which we are now 
involved offers unprecedented hope, if we are smart enough, to 
exploit the opportunities before us. Over the past year, DHS's 
highly capable science and technology directorate has 
implemented biowatch in approximately 30 cities. The 
President's commitment to building a strong biodefense is clear 
in the fiscal year 2005 budget proposal. R&D biodefense 
spending in the science and technology directorate alone is 
slated for a 42 percent increase over fiscal year 2004 levels. 
The S&T directorate and its current management has enjoyed the 
enthusiastic support of both the Executive and Legislative 
Branches. And we expect this to continue.
    That said, we must all recognize that the time has come to 
develop and implement a clear national strategy for biodefense 
that will allow us to focus on priorities, to discipline our 
spending, and to permit measurement toward concrete goals. The 
strategy presented by the President in the Homeland Security 
Presidential Directive 10, Biodefense for the 21st Century, 
defines the missions, sets the priorities, and assigns roles to 
key Federal partners. It gives the Department of Homeland 
Security specific responsibilities to coordinate these efforts. 
The committee will conduct rigorous oversight of DHS's efforts 
to develop a concrete strategy to implement this new directive.
    The panel before us represents the primary Federal partners 
assigned to mitigate the biothreat. As our committee moves to 
complete the first authorization bill for the Department of 
Homeland Security, we will be especially vigilant in assessing 
DHS efforts to craft a biodefense strategy.
    We must address the paramount need to prioritize research 
goals and objectives in consultation with the widest range of 
U.S. government and outside experts. As this committee so often 
stresses, credible intelligence will be a key factor in this 
prioritizing. I look forward to hearing the steps our witnesses 
have taken to work with the IAIP directorate and other elements 
of the intelligence community to incorporate our best 
intelligence into your planning for biodefense R&D and to levy 
new requirements to improve that intelligence. I also look 
forward to hearing the progress you have made in surveillance, 
detection, and diagnosis of bioterrorist threat agencies.
    Finally, we know only too well that an effective biodefense 
strategy must include unprecedented cooperation among Federal 
agencies. The Department of Homeland Security along with the 
Department of Health and Human Services and the Department of 
Defense, must coordinate their resources as never before to 
defeat the biothreat. Close coordination among these Federal 
departments will be increasingly important to develop the 
scientific expertise and R&D capabilities to meet the threat of 
new and more virulent agents in the year ahead.
    I, again, thank our distinguished witnesses for taking the 
time to be with us this afternoon. And at this time, I would 
yield to the gentleman from Texas, Mr. Turner, for his opening 
statement.
    Mr. Turner. Thank you, Mr. Chairman. It is good to have all 
of our witnesses here today to talk about this very, very 
important subject to Homeland Security.
    I want to thank all of our witnesses for their presence, 
Dr. Albright, Dr. Fauci, welcome back to our committee. We look 
forward to hearing from both of you once again. General 
Martinez and Dr. Raub, thank you so much for your presence here 
today. I also want to thank Dr. Shelley Hearne, who will appear 
momentarily to give us perspective on biodefense preparedness 
as well as Dr. Anna Johnson-Winegar, who has years of 
experience as a researcher and administrator of biological 
defense programs.
    It was one year ago that this committee held hearings on 
Project Bio-Shield. Following such consideration, we, along 
with our House colleagues, moved quickly to approve the bill, 
sending it to the Senate. Its final passage out of the Senate 
just two weeks ago is, in my judgment, long overdue, and I 
think once again, illustrates for us the fact that, in my 
judgment, we have lost the sense of urgency that we need to 
have for protecting the homeland that we all felt in the wake 
of the 9/11 attacks. The sense of urgency must be regained. I 
think we all understand that our terrorist enemies who are 
fully capable of striking again and looking for opportunities 
to do so.
    Fortunately, we have made some progress in preparing our 
Nation to combat a bio-terrorism attack. We do have a large 
strategic national stockpile of antibiotics and medical 
supplies. Public servants such as Dr. Fauci have worked hard to 
develop new vaccines, drugs, diagnostic devices, all of which 
we need in the defense against bio-terrorism.
    Our Department of Homeland Security has deployed new 
sensors to detect airborne pathogens in our major cities, and 
the Department of Defense has long made the protection of 
troops from chemical and biological weapons a priority of its 
research and procurement programs.
    Despite this good news, there is clear evidence that we 
need to do a whole lot more. We need to move much faster in 
protecting our Nation against the threat of bio-terrorism. Let 
me cite a few examples.
    It took us 2-1/2 years after the anthrax attacks to develop 
a strategy for bio-terrorism, a strategy that was released just 
a few weeks ago by the administration in the form of a 
Presidential directive. In reviewing this document, it appears 
from our briefings on the subject that it sets forth broad 
strategic goals and assigns specific tasks to specific 
agencies. It does not, however, seem to identify specific 
objectives, establish time frames for achieving those 
objectives, allocate resources, or clearly define the roles of 
the Federal, state, and local agencies in bio-terrorism 
prevention, preparedness, and response. In order to get this 
job done, this degree of detail must be attached to and 
provided as a part of this strategic plan to deal with the 
bioterrorist threat.
    Another example of our failure is that we still have not 
secured our national stocks of dangerous pathogens and the 
laboratories that house them, despite a requirement to do so in 
the 2002 Bioterrorism Preparedness Act.
    While expanded research is essential to improving our 
biodefense, it also brings more opportunities for the 
accidental or intentional escape of pathogens from legitimate 
facilities. The administration should fully implement the 
select agent regulations mandated by Congress as soon as 
possible.
    Another example of a shortcoming I think that still exists: 
While we have enough smallpox vaccine, from what I understand, 
to vaccinate every man, woman, and child in the Nation, it 
appears to me that it is still an open question as to whether 
or not we could vaccinate our population quickly enough if a 
smallpox outbreak occurred. The administration's goal of 
vaccinating 500,000 health care workers and first responders 
has not been met. The last time I checked, we had vaccinated 
under 50,000 people. And 40 percent of the States report that 
they are unable to vaccinate their populations within 10 days 
of an outbreak. The goals of the national smallpox vaccination 
program have not been achieved, and it is not clear how the 
administration is attempting to get that program back on track.
    In addition to the deficiencies in smallpox preparation, 
the trust for America's health reports that only two States are 
actually prepared to distribute the supplies that currently 
reside in the national stockpile. To prepare our Nation for a 
bioterrorist attack, every State and community in the country 
should have detailed plans outlining how the necessary 
medicines will be transported, where the medicines will be 
distributed, and who will be operating those distribution 
centers.
    Finally, Mr. Chairman, we need to acknowledge that while 
Project BioShield is a good first step, it is unlikely to 
provide the full range of countermeasures we need to prepare 
this Nation for a bioterrorist attack. We must take steps to 
ensure that the private sector and, if necessary, the Federal 
government can rapidly produce the counter-measures we need to 
combat the unknown, the resistant, or the bioengineered 
pathogens that could be used against us in a future bioterror 
attack.
    That is why I, along with 34 other Members of the House, 
recently introduced H.R. 4258, the Rapid Cures Act, to begin 
the process of building a national capability to respond more 
quickly to bioterrorism threats. And I hope that each of our 
witnesses will take a look at that legislation and advise me 
regarding your opinion and the merits of it.
    The legislation recognizes that it may never be possible to 
produce every medical countermeasure we need through Project 
BioShield, and that the growing power of biotechnology can 
render a pathogen like anthrax or smallpox immune to the 
vaccines and drugs that we do have on hand. We need to develop 
the mechanisms to go from bug to drug or the identification of 
a pathogen to the development of a countermeasure to combat it 
in as little as a few months or even weeks rather than the 
current 18-year average for drug development. Personally, I 
cannot think of another research goal that would bring more 
benefits to the security of this country and to the public 
health of this country than achieving this objective. I am 
interested in hearing from our witnesses today on this 
proposal.
    Mr. Chairman, bioterrorism is arguably the most significant 
threat we face, and I thank you for calling the hearing today 
to allow us to examine how we best move forward to develop a 
bioterrorism strategy for our nation.
    Thank you, Mr. Chairman.
    Chairman Cox. I thank the gentleman.
    The gentleman from Connecticut, the chairman of the 
Subcommittee on National Security of the Committee on 
Government Reform and Oversight, is recognized for purposes of 
an opening statement.
    Mr. Shays. I have no opening statement. I will just have 
questions. Thank you.
    Chairman Cox. The gentleman from Michigan.
    Mr. Camp. I am fine.
    Ms. McCarthy. I yield back.
    Chairman Cox. Does any member wish to be recognized for 
purposes of an opening statement? If not, the Chair will now 
call up testimony from the first panel. Let me remind witnesses 
that under our committee rules they should strive to limit 
their opening remarks to 5 minutes. Each witness's entire 
written statement will appear in the record. We will also allow 
the entire panel to testify before questioning any witnesses.
    Chairman Cox. The Chair now recognizes our first witness, 
the Honorable Penrose ``Parney'' Albright, Assistant Secretary 
for Science and Technology, the Department of Homeland 
Security, to testify. Secretary Albright, welcome back to the 
Committee on Homeland Security.

     STATEMENT OF THE HONORABLE PENROSE ``Parney'' ALBRIGHT

    Dr. Albright. Thank you, Chairman Cox. And good afternoon, 
Chairman, Congressman Turner, and the other distinguished 
members of the committee. I am pleased to appear before you 
today to discuss the progress of the science and technology 
directorate of the Department of Homeland Security, that it is 
making in the Nation's effort to prevent, protect against, 
respond to, and recover from acts of bioterrorism against the 
American people.
    President Bush has made strengthening the Nation's defenses 
against biological weapons a critical national priority. And, 
as the Chairman just pointed out, this has resulted in a joint 
Homeland Security Presidential directive, along with the 
National Security Council, entitled Biodefense for the 21st 
Century, that provides a comprehensive framework for our 
Nation's biodefense.
    The Department of Homeland Security, through the science 
and technology directorate, has explicit responsibilities in 
this integrated national effort.
    I want to briefly address how we work with the Department 
of Homeland Security's information, analysis, and 
infrastructure protection directorate and how their work is 
linked to the S&T directorate's work. The IAIP directorate 
assesses collected intelligence and information about threats 
and vulnerabilities from other agencies, and then takes 
preventative and protective action. They are partners in the 
total agencies to obtain, assess, and disseminate information 
regarding potential threats to America from terrorist actions. 
These threats and vulnerability assessments are inputs into the 
strategy and research, development, testing and evaluation 
activities of the science and technology directorate, and 
further inform S&T's interactions with the broader research and 
development community.
    The Presidential directive, Biodefense for the 21st 
Century, outlines four essential pillars of the Nation's 
biodefense program and provides specific directives to further 
strengthen the significant gains that have been put in place in 
the past 3 years.
    The four pillars of the program are:
    First, threat awareness, which includes biological weapons-
related intelligence, vulnerability assessments, and 
anticipation of future threats. And then, prevention and 
protection, surveillance and detection, and response and 
recovery.
    The Department of Homeland Security and S&T directorate 
have a role and responsibility in each of these four pillars of 
the national biodefense program. Our contributions and planned 
activities include providing a continuing all-WMD assessment 
effort within the science and technology directorate. This work 
is being performed for IAIP. The first reports describing the 
capabilities of 20 terrorist groups in biological, chemical, 
radiological, nuclear, cyber, and advanced explosives threats 
areas have been completed and delivered to IAIP.
    Furthermore, the S&T directorate has embedded a team of WMD 
scientific experts to provide technical assistance to IAIP 
analysts, and is installing a knowledge information tool within 
IAIP to enable easy access to reports and all the supporting 
data and information.
    The S&T directorate has established a national biodefense 
analysis and countermeasure center, or NBACC, with the missions 
of threat characterization, forensics and attribution, and the 
establishment of a knowledge center in the biological area. The 
S&T directorate is further coordinating with the Departments of 
Defense, Health and Human Services, and Agriculture to 
establish a national interagency biodefense campus at Fort 
Detrick. The S&T directorate addresses the full range of 
biological threats, but the initial emphasis is on active 
defense against high consequence threats, those that can 
inflict damage that would significantly challenge this Nation's 
immediate ability to respond.
    In addressing these biological threats, the S&T directorate 
has the leadership role in several key areas and partners with 
lead agencies in others. Those areas in which the S&T 
directorate provides significant leadership are, first, 
providing an overall end-to-end understanding of an integrated 
biodefense so as to guide the Secretary and the rest of the 
Department in its responsibility to coordinate the Nation's 
efforts to deter, detect, and respond to biological acts of 
terrorism.
    We also provide scientific support, as I mentioned earlier, 
to the intelligence community and IAIP in prioritizing the 
biothreats. We are, again, as the Chairman noted, developing 
and have implemented early warning and detection systems to 
permit timely response to mitigate the consequences of the 
biological attack. And we conduct technical forensics to 
analyze and interpret materials recovered from an attack to 
support attribution.
    DHS also supports our partnering departments and agencies 
where they are leads in other key areas of an integrated 
biodefense. The Department of Health and Human Services on 
medical countermeasures and mass casualty response, USDA on 
agriculture, USDA and HHS on food security, and the 
Environmental Protection Agency on decontamination and on water 
security.
    The Presidential directive HSPD-10, as well as other HSPDs, 
identify national objectives and priorities and departmental 
agency roles in addressing those particular national priorities 
in the biodefense arena. The S&T directorate has been and 
continues to be an active participant in interagency 
activities. We participated in the joint NSC/HSC biodefense 
end-to-end study, which led directly to HSPD-10, and this was 
followed by an interagency review conducted under the aegis of 
the NSC/HSC for fiscal year 2006 to 2010 science and technology 
needs to support the national biodefense strategy as 
articulated in HSPD-10.
    This and other inputs including those from the 
counterproliferation technology coordinating committee, the 
National Science and Technology Council's weapons of mass 
destruction medical countermeasures committee, and its 
associated subcommittees, and various HHS-led risk management 
meetings which help guide medical countermeasure procurements, 
are being documented in the national strategic plan for 
Homeland Security science and technology.
    The weapons of mass destruction medical countermeasures 
subcommittee provides an interagency forum for discussing and 
prioritizing medical countermeasure needs to be pursued under 
BioShield, and an HSC-led interagency biosurveillance committee 
provides a forum for coordinating and integrating the multiple 
activities in this area to provide an integrated biowarning and 
situational awareness system.
    And then at other levels of coordination, there are strong 
bilateral efforts around key elements of the strategy. For 
example, examples include strong and frequent collaborations on 
BioShield with HHS, the development of a coordinated civilian 
and military surveillance and detection system with DOD, and 
the development and execution of a national strategy for 
agricultural biosecurity with the USDA.
    The needs in three areas of this integrative biodefense 
have turned out to be so great to have generated Presidential 
initiatives. And there are three of them. These three 
initiatives are: BioShield, which we have already heard quite a 
bit about. One important point to make about that is that the 
S&T directorate played a significant role in determining which 
agents constitute material threats and in developing the 
scenarios to inform decisions on the quantity of 
countermeasures required. We have certified one material 
threat, which is anthrax, have two additional underway, and 
three more are pending.
    We also play a key role in the biosurveillance initiative 
in terms of first operating the biowatch system, deploying the 
second generation system to significantly expand the number of 
detectors in the highest threat cities and key facilities, and 
in developing advanced detection systems.
    And then in addition, the S&T directorate is bringing 
significant contributions and end-to-end studies of key 
agricultural and food threats through the development of 
advanced diagnostics and through R&D conducted jointly with 
USDA at Plum Island Animal Disease Center.
    Thus, the science and technology programs conducted within 
the Department of Homeland Security fully support the national 
biodefense program as stated in HSPD-10 and other Homeland 
Security Presidential directives. Moreover, they are conducted 
in an act of 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 the Nation's population and its agricultural 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 that my formal statement be submitted for 
the record.
    Mr. Chairman, Congressman Turner, and members of the 
committee, I thank you for the opportunity to appear before you 
today and look forward to your questions.
    Chairman Cox. Thank you, Secretary Albright. Your written 
statement has been entered into the record.
    [The statement of Dr. Albright follows:]

         Prepared Opening Statement of Dr. Penrose C. Albright

    Good afternoon Chairman Cox, Congressman Turner, and distinguished 
members of the Committee. I am pleased to appear before you today to 
discuss the progress the Science and Technology Directorate of the 
Department of Homeland Security is making in the nation's efforts to 
prevent, protect against, respond to, and recover from, acts of 
bioterrorism against the American people.
    President Bush has made strengthening the nation's defenses against 
biological weapons a critical national priority. Although significant 
progress has been made to protect America, President Bush instructed 
Federal departments and agencies to review their efforts and find 
better ways to secure America from bioattacks.
    This review resulted in a joint Homeland Security Presidential 
Directive (HSPD-10)/National Security Presidential Directive (NSPD-33) 
entitled Biodefense for the 21st Century. that provides a comprehensive 
framework for our nation's biodefense. This directive builds upon past 
accomplishments, specifies 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 explicit responsibilities in this 
integrated national effort. In particular, I want to highlight the 
strategy, planning and accomplishments to date of S&T in the area of 
biodefense, and the essential collaborations with key Federal partners, 
including those represented here today.

    BIODEFENSE
    Before I speak directly to the biodefense efforts of the S&T 
Directorate, I want to briefly address the role of the DHS's 
Information Analysis and Infrastructure Protection Directorate, and how 
their work is linked to the S&T Directorate. The Information Analysis 
and Infrastructure Protection (IAIP) Directorate assesses intelligence 
and information about threats and vulnerabilities from other agencies 
and takes preventative and protective action. They are partners in the 
total interagency efforts to obtain, assess and disseminate information 
regarding potential threats to America from terrorist actions. These 
threat and vulnerability assessments are inputs into the strategy and 
research, development, testing and evaluation (RDT&E) activities of the 
Science and Technology Directorate. For example, agriculture and food 
are two of the multiple critical infrastructure sectors identified by 
Homeland Security Presidential Directive 7.As such, they fall within 
the domain of the IAIP Directorate; they also are within the domain of 
concern for biological threats.
    Mission and Objectives:
    The presidential directive Biodefense for the 21st Century outlines 
four essential pillars of the nation's biodefense program and provides 
specific directives to further strengthen the significant gains put in 
place in the past three years. Specific direction to departments and 
agencies to conduct this biodefense program is contained in a 
classified version of the directive and is not provided in the present 
document. However, the four pillars of the program are:
         Threat Awareness, which includes biological weapons-
        related intelligence, vulnerability assessments, and 
        anticipation of future threats. New initiatives will improve 
        our ability to collect, analyze, and disseminate intelligence 
        on biological weapons and their potential users.
         Prevention and Protection, which includes interdiction 
        and critical infrastructure protection. New initiatives will 
        improve our ability to detect, interdict, and seize weapons 
        technologies and materials to disrupt the proliferation trade, 
        and to pursue proliferators through strengthened law 
        enforcement cooperation, including through such mechanisms as 
        Interpol.
         Surveillance and Detection, which includes attack 
        warning and attribution. New initiatives will further 
        strengthen the biosurveillance capabilities being put in place 
        in fiscal year 2005.
         Response and Recovery, which includes response 
        planning, mass casualty care, risk communication, medical 
        countermeasures, and decontamination. New initiatives will 
        strengthen our ability to provide mass casualty care and to 
        decontaminate the site of an attack.
    The Department of Homeland Security has a role and responsibility 
in each of these four pillars of the national biodefense program. The 
S&T Directorate has the responsibility to lead the Department's RDT&E 
activities to support the national biodefense objectives and the 
Department's mission.

        Accomplishments and Planned Activities:
    Dr. Charles E. McQueary, Under Secretary for Science and 
Technology, has previously testified before the U.S. House of 
Representatives, Appropriations Subcommittee on Homeland Security; the 
U.S. House of Representatives, Subcommittee on Cybersecurity, Science, 
and Research and Development; and the U.S. House of Representatives, 
Science Committee. The accomplishments to date and planned activities 
for FY 2005 of the Science and Technology Directorate and its RDT&E 
related to biological threats have been described in the written 
testimony for the record for those hearings and I will not repeat here 
the details already provided in those fora. However, there are some 
specific accomplishments and planned activities I want to describe 
because they illustrate the integrated efforts within the Department of 
Homeland Security and other Federal departments and agencies.
    The Science and Technology Directorate contributes to each of the 
key areas of the national biodefense program. Our contributions and 
planned activities include:
         The S&T Directorate is funding a continuing all-WMD 
        assessment effort. The program focuses on determining the 
        capabilities of state and non-state terrorist groups to develop 
        and deliver or deploy any chemical/biological/radiological/
        nuclear/explosives (CBRNE) agent within the United States. This 
        work is being performed for IAIP; and the first reports, 
        describing the capabilities of 20 Tier 0 and Tier 1 groups in 
        biological, chemical, radiological, nuclear, cyber, and 
        advanced explosives (or energetics) threat areas, have already 
        been completed and delivered to IAIP. Furthermore, the S&T 
        Directorate is in the process of embedding a team of WMD 
        scientific experts to provide technical assistance to IAIP 
        analysts and is installing a pilot Knowledge Information Tool, 
        which enables access to the reports and all of the supporting 
        data and information. .
         The S&T Directorate has established the National 
        Biodefense Analysis and Countermeasures Center (NBACC), with 
        the missions of threat characterization, forensics and 
        attribution, and bio-knowledge. In order to fulfill these 
        missions, the NBACC is comprised of three centers: the Bio 
        Threat Characterization Center (BTCC), the National 
        BioForensics Center (NBFAC) and the Biosecurity Knowledge 
        Center (BKC). These components will provide a scientific basis 
        to understanding the biological threat and become part of a 
        data and telecommunications network enabling information 
        sharing and threat and vulnerability analysis among a diverse 
        set of users.
         The S&T Directorate is coordinating with the 
        Departments of Defense, Health and Human Services, and 
        Agriculture to establish the proposed National Interagency 
        Biodefense Campus at Ft. Detrick. The NBACC is proposed to 
        include the BTCC, focusing on threat characterization, and 
        NBFAC, which provides interagency forensic capability. The 
        synergy at this center will allow for integrated biodefense 
        research programs across the government, better address the 
        priorities established in the President's directive and provide 
        scientific rigor to threat and vulnerability assessments for 
        IAIP.
         The S&T Directorate has developed and implemented a 
        Threat-Vulnerability Integration System prototype at IAIP. That 
        system provides advanced information discovery, analysis, and 
        visualization tools to IAIP analysts and will be used in 
        concert with the Threat-Vulnerability Mapping System. Such 
        advanced tools can be applied to the biodefense problem 
        specifically or all-WMD analysis in general. To ensure use of 
        these systems is optimized, the S&T Directorate has detailed 
        technical personnel to IAIP.
    The S&T Directorate addresses the full range of biological threats, 
but the initial emphasis in on active defense against high consequence 
threats- those that can inflict damage which would significantly 
challenge this Nation's immediate ability to respond, i.e. thousands or 
tens of thousands of serious casualties and/or economic losses in the 
tens of billions of dollars or higher. Such threats include large 
outdoor and indoor aerosolized releases of non-contagious and 
contagious pathogens, contamination of selected bulk food supplies, 
foreign animal diseases, highly virulent plant diseases, engineered 
threats, multiple small attacks, and zoonotic diseases.
    In addressing these activities, the S&T Directorate has a 
leadership role in several key areas and partners with lead agencies in 
others. Those areas in which DHS provides significant leadership are:
         Providing an overall end-to-end understanding of an 
        integrated biodefense, so as to guide the Secretary and the 
        rest of the Department in its responsibility to coordinate the 
        Nation's efforts to deter, detect, and response to biological 
        acts of terrorism
         Providing scientific support to the intelligence 
        community and IAIP in prioritizing the bio-threats
         Developing early warning and detection systems to 
        permit timely response to mitigate the consequence of a 
        biological attack
         Conducting technical forensics to analyze and 
        interpret materials recovered from an attack to support 
        attribution
         Operation of the Plum Island Animal Disease Center to 
        support both research and development (R&D) and operational 
        response to foreign animal diseases such as foot and mouth 
        disease.
    DHS 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 U.S. Department of 
Agriculture (USDA) on agriculture; USDA and HHS on food security and 
the Environmental Protection Agency (EPA) on decontamination and on 
water security.

Interagency Collaboration:
    The previously mentioned presidential directive Biodefense for the 
21st Century, as well as other Homeland Security Presidential 
Directives (HSPDs) including HSPD-9, Defense of United States 
Agriculture and Food; HSPD-8, National Preparedness; HSPD-4, National 
Strategy to Combat Weapons of Mass Destruction; and HSPD-7, Critical 
Infrastructure Identification, Prioritization, and Protection, 
identifies national objectives and priorities, and departmental and 
agencies? roles in addressing these national objectives.
    The S&T Directorate has been, and continues to be an active 
participant in these interagency activities as illustrated by our 
participation in the biodefense program. At the highest level, the 
joint National Security Council-Homeland Security Council (NSC-HSC) 
Biodefense End-to-End Study and the ensuing HSPD-10/NSPD-33 (Biodefense 
for the 21st Century) laid out the overall strategy, department and 
agency roles, as well as specific objectives and called for periodic 
reviews to plan, monitor and revise implementation. This was followed 
by an interagency review, conducted under the aegis of the NSC-HSC, of 
specific FY 2006-FY 2010 science and technology needs to support the 
national biodefense strategy as articulated in HSPD-10. This and other 
inputs such as those from the Counterproliferation Technology 
Coordination Committee (CTCC), the National Science and Technology 
Council's Weapons of Mass Destruction Medical Countermeasures Committee 
(WMD-MCM) and its associated subcommittees, and HHS--led risk 
management meetings which help guide medical countermeasures 
procurement activities are being documented in the National Strategic 
Plan for Homeland Security Science and Technology as required in the 
Homeland Security Act of 2002.
    The Weapons of Mass Destruction Medical Countermeasures 
Subcommittee (WMD-MCM) provides an interagency forum for discussing and 
prioritizing medical countermeasure needs to be pursued under BioShield 
and an HSC led interagency Biosurveillance Committee provides a forum 
for coordinating and integrating the multiple activities in this area 
to provide an integrated biowarning and situational awareness system. 
At still the next level of coordination, there are strong bilateral 
efforts around key elements of the strategy. Examples of this 
coordination including strong and frequent collaborations on Bioshield 
(HHS/DHS), the development of coordinated civilian and military 
surveillance and detection systems (DHS/DoD) and the development and 
execution of a National Strategy for Agricultural Biosecurity (DHS/
USDA).

Presidential Initiatives:
    The needs in three areas of this integrated biodefense turned out 
to be so great as to have generated Presidential Initiatives to address 
them. These three initiatives are:
    BioShield: which seeks to speed development and use of new 
biomedical countermeasures by creating a guaranteed market for these 
`orphan drugs' and removing some of the barriers to their development 
and emergency use. DHS's S&T Directorate plays a significant role in 
this in determining which agents constitute ``material threats'' and in 
developing scenarios that inform decisions on the quantity of 
countermeasures required. We have certified one ``material threat'' 
(anthrax), have two additional underway, and three more are pending.
    Biosurveillance Initiative: which seeks to enhance systems that 
monitor the Nation's health (human, animal and plant) and its 
environment (air, food, water) and to integrate these with intelligence 
data to provide early detection of an attack and the situational 
understanding needed to guide an effective response. The S&T 
Directorate plays a major role in the Biosurveillance Initiative in 
operating its 1st Generation BioWatch System, in deploying a 2nd 
Generation system which significantly expands the number of collectors 
in the highest threat cities and at key facilities (e.g. transportation 
systems), and in developing advanced detection systems to further 
increase the capabilities. We are also designing the information system 
that will be use to integrate health and environmental monitoring 
information from the sector specific agencies with intelligence data 
from the IAIP Directorate. Implementation of this system will actually 
be initiated by the IAIP Directorate in FY 2005, but the S&T 
Directorate will continue to supply subject matter expertise in 
biological threat and defense.
    Food and Agricultural Initiative: which seeks to enhance the 
security of our agricultural and food infrastructures. DHS activities 
in this area are led by the IAIP Directorate--but the S&T Directorate 
brings significant contributions in end-to-end studies of key 
agricultural and food threats, through the development of advanced 
diagnostics, and through R&D conducted jointly with USDA at the Plum 
Island Animal Disease Center.

CONCLUSION
    The Science and Technology Directorate's programs conducted within 
the Department of Homeland Security fully support the national 
biodefense program as stated in the presidential directive Biodefense 
for the 21st Century, and other Homeland Security Presidential 
Directives. Moreover, they 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, Congressman Turner, 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.

    Chairman Cox. Our next witness is Major General Lester 
Martinez-Lopez, commanding general, U.S. Army Medical Research 
and Materiel Command, at Fort Detrick, Maryland. Your written 
statement will also be entered into the record, and we welcome 
your oral testimony. General, welcome.

        STATEMENT OF MAJOR GENERAL LESTER MARTINEZ-LOPEZ

    General Martinez-Lopez. Mr. Chairman, distinguished members 
of the committee, thank you for the opportunity to briefly 
discuss the national interagency biodefense campus that is 
being planned at Fort Detrick, Maryland.
    As commanding general of the United States Army Medical 
Research and Materiel Command as Fort Detrick, I am responsible 
for delivering the best medical solutions for today and 
tomorrow to enhance, protect, and treat the warfighter on point 
for the Nation. This responsibility includes the protection 
against biological weapons.
    Today, Fort Detrick is embarking upon a vision to become 
the home of the national interagency biodefense campus.
    As the anthrax attacks demonstrated, the new biothreat 
respects no borders and knows no boundaries. Our homeland is at 
continual risk. After the attacks, many turned to Fort Detrick 
for answers because throughout its history, Fort Detrick has 
contributed scientific breakthroughs and medical solutions for 
their Armed Forces and the Nation. With Fort Detrick's United 
States Army Medical Research Institute of Infectious Diseases, 
expertise has a cornerstone, and in partnership with the 
National Institute of Health, the Department of Homeland 
Security, and the Department of Agriculture, I believe the 
National Interagency Biodefense Campus will be the Nation's 
primary center for development of defenses against biological 
terrorist attacks. These four agencies, complementary 
facilities, programs, and expertise in the context of the 
national biodefense campus will comprise the cycle of discovery 
for the badly needed medical solutions against this biothreat.
    To take this campus concept from a vision to a reality, 
senior leaders from participating Federal agencies met in late 
May 2002. We developed a strategy, established combined 
facility working groups, and explore areas of research 
collaboration. One month later, the National Biodefense 
Interagency Coordinated Committee was established. This 
interagency work led to the completion of the National 
Interagency Biodefense Campus master plan. With your help, the 
National Institute of Food Allergies and Infectious Diseases 
will break ground for its new facility this year. The National 
Biosecurity Analysis and Countermeasures Center, NBACC, of the 
Department of Homeland Security, will shortly follow, and, as 
you may know, the Department of Agriculture planned pathogen 
laboratory is already at the Fort Detrick campus.
    Let me share with you what each of these partnering 
organizations will bring to the table. For 34 years, USAMRMC 
has safely handled the world's deadliest pathogens and is home 
to most of the Nation's experts in infectious aerosol as well 
as biological threats. These world-renowned professionals have 
also crossed the globe to investigate or support infectious 
disease outbreaks and have provided training in how to respond 
to incidents. The USAMRMC Building itself has an aerobiology 
lab, biosafety labs two, three, and four, and has the only 
biosafety level four patient care suite in the Nation.
    The National Institute of Allergies and Infectious Diseases 
brings incredible expertise and resources from their previous 
efforts to understand, treat, and ultimately prevent a myriad 
of infectious immunologic and allergic diseases that threaten 
hundreds of millions of people worldwide. The Department of 
Homeland Security will establish a center that will conduct 
research to better understand classical as well as new and 
emerging biological threats to humans, plants, and animals. And 
in support of the FBI and other Federal agencies, a second 
center will provide validated authoritative forensic analysis.
    Finally, the Fort Detrick's foreign disease with science 
research unit of the United States Department of Agriculture 
will continue its work on pathogen detection and identification 
of crop protection. In addition, the National Cancer Institute 
already has a large campus at Fort Detrick. Although their 
mission is direct research aimed at identifying the causes and 
treatment for cancer, their facilities and scientific expertise 
will complement and augment the biodefense campus work. The 
campus will mass research facilities, knowledge and expertise, 
creating a brain trust of civilian and military scientists in a 
way that will minimize duplication of effort, technology and 
facilities, while identifying ways to improve the ability of 
the labs to produce science, technology, and products that are 
faster, better, and cheaper.
    The campus will share a common infrastructure and support 
requirements, such as roadways, libraries, cafeteria, 
regulatory and quality assurance offices, and will share 
securities, biosafety, and biosurety responsibility. We are 
also looking at cost saving mechanisms such as enhanced use 
lease for a central utility plan. We are making real progress 
every day toward division of the national interagency 
biodefense campus at Fort Detrick, and will be--which that will 
be a collaborative center of excellence for our Nation. All 
partners have established good working relationships, and the 
community is supportive. I am excited to be part of this bright 
future.
    Mr. Chairman, this concludes my remarks, and I will be 
pleased to answer your questions.
    Chairman Cox. Thank you, General.
    Chairman Cox. Our next witness is Dr. Anthony Fauci, 
director of the National Institute of Allergy and Infectious 
Diseases, the Department of Health and Human Services, NIH. 
Thank you, Dr. Fauci. Welcome back.

                 STATEMENT OF DR. ANTHONY FAUCI

    Dr. Fauci. Thank you very much, Chairman Cox, Mr. Turner, 
members of the committee, I appreciate the opportunity to again 
appear before you as I did about this time last year.
    I was asked by committee staff to briefly address three 
areas of the NIH research response to the threat of 
bioterrorism. And those are a summary, which I will give 
shortly, of the biodefense research activities, how we 
coordinate these research activities among agencies, and, 
finally, how the research and development priorities are based 
on threat assessment.
    Chairman Cox. Dr. Fauci, if you would suspend just for a 
moment. We have had two bells indicating that there is a vote 
on the floor. I would propose that we go forward with your oral 
testimony. And Dr. Raub, we will recognize you, but my 
understanding is that you do not have a formal statement. That 
will permit members to return following floor votes to begin 
questioning the panel. So I want members to be alert to remain 
for the formal testimony. And Dr. Fauci, I want you to not be 
bothered by the buzzers that probably will continue to 
interrupt your testimony.
    Dr. Fauci. Will do.
    Chairman Cox. Please proceed.
    Dr. Fauci. At your pleasure. Okay. Next slide.
    Again, just historically, as referred to by you and Mr. 
Turner, about a year ago when I discussed with this committee 
the strategic plan that we had brought up in response to being 
able to execute the mandate of doing the research necessary to 
develop appropriate countermeasures for biodefense threats, we 
put together a strategic plan, which I briefly outlined for you 
at the time, and also we put together a research agenda for 
Category A, and Category B and C agents.
    Since that time, we have now put together a progress report 
on both of those. And I would recommend to you and your staff, 
if you get the opportunity, to page through those. It is 
available on the Web, in which we outline not only the 
accomplishments that have occurred since that time, but also a 
supplementation of where we will be going in the future. So let 
me briefly outline some of that for you.
    The first that I alluded to last year was the need for 
building up both our human capital and our physical 
infrastructure to be able to do the research necessary to 
develop these countermeasures. Since that time, significant 
progress has been made. We now have the funding that has been 
disbursed for the development of two national biocontainment 
laboratories or BSL-4s, one in Texas and one in Boston; nine 
additional regional biocontainment laboratories, or BSL-3s. 
And, importantly, again, I discussed with the committee last 
year the need to get the best and the brightest of the 
infectious diseases, microbiology, and immunology scientific 
community involved in the biodefense effort. By the awarding of 
our regional centers of excellence for biodefense and emerging 
infectious diseases, eight in number, in fact, I believe we 
have succeeded in that, because we have the best of our 
established and now younger people coming into the field.
    And, finally, there have been four new facilities that are 
government-owned, one going up right now in construction on the 
NIH campus, a BSL-3. Dr. Martinez-Lopez referred to the BSL-4 
that we are going to be collaborating with on the campus in 
Fort Detrick as well as the BSL-3 in Rockville and the BSL-4 in 
the Rocky Mountain Laboratories in Hamilton, Montana.
    What about the research? I put the slide together to show 
you the continuum of the fundamental basic research in concept 
development of which we have been quite successful. I will give 
you some examples, but I will be happy to discuss this during 
the questioning period. In addition, several products already 
have gone from the preclinical and the animal model up through 
phase one and into phase two, and right now we are pushing the 
envelope as we promised towards the development of these three 
types of products, diagnostics, therapeutics, and vaccine. And 
as you know, as we discussed last time, it is at this point 
where Project BioShield will kick in.
    What about these countermeasure developments? Significant 
progress has been made in smallpox, the development of a safer, 
not reactogenic smallpox vaccine. In other words, the Modified 
Vaccinia Ankara that I mentioned to you, we had to prove that 
it was effective in animals at the same time we are proving it 
is safe in humans. Both of those things have gone on. A couple 
studies have been completed. We have shown in a monkey model 
and in a mouse model that it protects these animals from 
challenge with either smallpox or its equivalent. And this is 
an important issue with regard to the FDA's ``two animal rule'' 
for approval.
    With regard to anthrax, we are well into the clinical 
trials of the recombinant protective antigen, contracts have 
been let, and we are on our way to getting that into the 
stockpile.
    Also, since we spoke last, we now have an Ebola vaccine 
that protects monkeys that is now in a phase one clinical trial 
in humans started on the NIH campus in November of 2003. We 
also made advances in therapeutics. We are testing a 
therapeutic against smallpox as well as, based on the 
pathophysiology of anthrax, ways in which we can block the 
actual toxin. We know we have very good antibiotics against 
anthrax, we know we can block the toxin in people with advanced 
diseases, and some in-roads that have been made in diagnostics 
in the arena of smallpox as well as anthrax.
    Let me briefly address the question regarding coordination 
of biodefense activities. There are three levels. At the NIH, 
as you are aware, the NIAID is by far the lead institute in 
executing the research in bioterror agents. But there are other 
institutes that are involved also at NIH, and I chair a 
committee that is called the NIH Biodefense Research 
Coordinating Committee, in which we coordinate among the NIH 
institutes.
    At the level of the Department, the coordination falls 
under the auspices of the Office of the Assistant Secretary for 
Public Health Emergency Preparedness, where the NIH, the FDA, 
and the CDC are coordinated. And at the Federal Government 
level, it is coordinated at the White House by the Homeland 
Security Council and the National Security Council. And these 
are the Federal agencies involved. Predominantly, DHS, HHS, and 
DOD, which are represented here at this hearing, as well as 
other relevant agencies.
    And, finally, the question was asked: How do we establish 
the research and development priorities based on threat 
assessment? The first was the CDC category A, B, and C agent 
designation, which we have made the foundation for the research 
direction that we put into our original strategic plan. Right 
now, currently the Department of Homeland Security has taken 
the lead in providing us with continual threat assessments, and 
we rely heavily on the Department to work with us in a 
collaborative way so that we can direct our research toward the 
appropriate groups. That is my formal statement, Mr. Chairman. 
I would be happy to answer questions later.
    Chairman Cox. Thank you, Dr. Fauci.
    [The statement of Dr. Fauci follows:]

   The NIH Biomedical Research Response to the Threat of Bioterrorism

              Prepared Statement of Anthony S. Fauci, M.D

    Mr. Chairman and Members of the Committee, thank you for the 
opportunity to speak with you today about the role of the National 
Institutes of Health (NIH) in the execution of our national biodefense 
research strategy.
    The destruction of the World Trade Center, the attacks on the 
Pentagon and an airliner over Pennsylvania, and the anthrax attacks in 
the fall of 2001 clearly exposed the vulnerability of the United States 
to acts of terrorism. In particular, the anthrax attacks made it very 
clear that the possibility of the use by terrorists of deadly pathogens 
or biological toxins such as those that cause anthrax, smallpox or 
botulism represents a serious threat to our Nation and the world. The 
Administration and Congress responded aggressively to this threat by 
significantly increasing funding for biodefense preparedness and 
research.
    The National Institute of Allergy and Infectious Diseases (NIAID) 
is a component of NIH and a leading federal agency for biomedical 
research concerning potential agents of bioterrorism that directly 
affect human health. NIH, and particularly NIAID, has devoted the 
increased biodefense research funding to an aggressive, broadly based 
research program designed to provide the American people with medical 
countermeasures, i.e. vaccines, therapeutics, and diagnostics against a 
range of bioterrorist threats. My remarks today will specifically 
address three aspects of our biodefense research activities. I will 
first describe the NIH biodefense research program, including a few 
examples of our recent accomplishments. Next, I will summarize how NIH 
biodefense research is coordinated with research carried out by other 
Federal agencies. I will close by discussing how NIH is informed about 
and responds to new bioterror threats that might arise.

NIH Biodefense Research
    The NIH research agenda for defense against bioterrorism was 
developed through a comprehensive and systematic strategic planning 
process. In February 2002, we convened the Blue Ribbon Panel on 
Bioterrorism and Its Implications for Biomedical Research, with 
membership composed of distinguished researchers from academic centers, 
private industry, government civilian agencies, and the military. Three 
key documents were developed based on this panel's advice and on 
extensive discussions with other Federal agencies: the NIAID Strategic 
Plan for Biodefense Research, the NIAID Research Agenda for CDC 
Category A Agents (for those agents that pose the gravest threat), and 
the NIAID Research Agenda for CDC Category B and C Agents (agents whose 
biological properties make them more difficult to deploy or less likely 
to cause widespread harm). The Strategic Plan provides a blueprint for 
the conduct of basic research on microbes and host immune defenses, as 
well as targeted, milestone-driven development of drugs, vaccines, 
diagnostics and other interventions that would be needed 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.
    NIH has moved rapidly to execute its biodefense strategic plan and 
significant progress toward reaching many of the goals set forth in the 
research agendas has already been made, as described in two recent 
progress reports. With regard to basic research, which is needed to 
understand more about how pathogens interact with human hosts, NIAID-
supported researchers and their international colleagues have 
completely sequenced the genomes of representative bacteria considered 
to be bioterror threats, including multiple strains of the anthrax 
bacterium, as well as at least one strain of every potential viral and 
protozoan bioterror pathogen. Another NIAID program is supporting 
studies of the human innate immune system, which is comprised of 
broadly active ``first responder'' cells and other non-specific 
mechanisms that are the first line of defense against infection. The 
development of methods to boost innate immune responses could lead to 
fast-acting countermeasures to mitigate the effects of a wide variety 
of bioterror pathogens or toxins; in addition, manipulation of the 
innate immune system could lead the way towards the development of 
powerful adjuvants that can be used to increase the potency and 
effectiveness of vaccines.
    NIH also has moved aggressively to expand national biodefense 
research capabilities by investing in several research infrastructure 
development programs, including manpower and facilities. For example, 
NIAID recently funded eight Regional Centers of Excellence for 
Biodefense and Emerging Infectious Diseases Research. This nationwide 
network of multidisciplinary academic centers will conduct wide-ranging 
research on infectious diseases that could be used in bioterrorism, and 
will develop diagnostics, therapeutics and vaccines needed for 
biodefense. In addition, these Centers will serve as the training 
ground for future generations of biodefense researchers. The Centers 
also partner with State and local public health agencies to ensure the 
strongest coordinated response to a bioterrorist event. In addition, 
NIAID is supporting the construction of two National Biocontainment 
Laboratories (NBLs), which will include facilities built to Biosafety 
Level 4 standards and will therefore be capable of safely containing 
any pathogen, as well as nine Regional Biocontainment Laboratories 
(RBLs) with Biosafety Level 3 facilities. These high-level research 
laboratories will provide the secure space needed to carry out the 
nation's expanded biodefense research program in a setting of safety 
for both biodefense workers and the surrounding community. Other 
ongoing projects will expand intramural facilities at Bethesda and 
Rockville, Maryland, at our Rocky Mountain Laboratories in Hamilton, 
Montana, and in Frederick, Maryland.
    The ultimate goal of all NIH biodefense research is the creation of 
new and effective medical countermeasures, including vaccines, 
therapeutics, and diagnostics against potential bioterror agents. 
Substantial progress toward this goal has already been achieved. In the 
area of therapeutics, for example, NIAID-supported scientists have 
identified a drug that may prove useful in treating both smallpox and 
the complications of smallpox vaccination. This agent, called 
cidofovir, is approved by the FDA for treating viral eye infections in 
HIV-infected patients. NIAID studies also are investigating the use of 
antibodies that can bind to and block the action of toxins produced by 
the anthrax bacterium, as well as botulinum toxin.
    New and improved strategies for the development of vaccines against 
smallpox, anthrax and other potential bioterror agents are being 
vigorously pursued, with the objective of adding them to the Strategic 
National Stockpile (SNS) as quickly as possible. For example, NIAID is 
supporting and overseeing the rapid development of the next-generation 
anthrax vaccine known as recombinant protective antigen, or rPA. 
Clinical trials of rPA are ongoing; results to date build on findings 
in animal studies that suggest the vaccine is safe and capable of 
evoking a robust immune response. Researchers also will test, in 
animals, whether protection against anthrax can be enhanced by 
receiving the rPA vaccine in addition to antibiotic therapy following 
exposure to anthrax spores. This development effort is on track for 
Project BioShield to award contracts this year to achieve the goal of 
adding 75 million doses of rPA vaccine to the SNS to protect 25 million 
U.S. citizens.
    NIAID-supported researchers also are testing several new smallpox 
vaccines that may prove at least as effective as the current smallpox 
vaccine, and can be used by a broader population, including those who 
are immunocompromised. One of these, modified vaccinia Ankara (MVA), is 
based on a strain of the vaccinia virus that replicates less robustly 
than the traditional Dryvax vaccinia virus, and which is also known to 
cause fewer side effects. Human trials of MVA vaccines are under way at 
NIH and elsewhere. Encouragingly, recent studies by NIAID intramural 
scientists and their colleagues have shown that MVA protects monkeys 
and mice from smallpox-like viruses. NIH also has launched the first 
human trial of a vaccine designed to prevent infection with Ebola 
virus. The trial vaccine is made from parts of the viral DNA, and is 
similar in design to other investigational vaccines that hold promise 
for controlling such diseases as AIDS, SARS, and infection with West 
Nile virus.

Coordination of Biodefense Research
    Although NIH is a leading agency in government-sponsored biomedical 
biodefense research on agents that directly affect humans, 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, the 
NIH biodefense research agenda and activities are coordinated at three 
distinct levels: within NIH, within DHHS, and across the government as 
a whole.
    Within NIH, NIAID is responsible for the bulk of NIH-sponsored 
biodefense research; other NIH institutes, however, also make 
significant contributions. The focal point for trans-NIH coordination 
and planning of biodefense activities is the NIH Biodefense Research 
Coordinating Committee. I am Chairman of this committee, which meets at 
least quarterly or more often, as needed. It is administered by the 
NIAID Office of Biodefense Research, which also serves as liaison 
office for NIH contacts with other federal agencies such as DoD and DHS 
regarding biodefense research and response.
    At the level of the Department of Health and Human Services (DHHS), 
coordination of biodefense research between the CDC, NIH, FDA and other 
agencies within DHHS is the responsibility of the DHHS Office of the 
Assistant Secretary for Public Health Emergency Preparedness (ASPHEP). 
The ASPHEP Office of Research and Development Coordination holds 
periodic meetings with all governmental stakeholders in the development 
of medical countermeasures.
    Members of my staff also meet regularly with the research community 
at Fort Detrick and the U.S. Army Medical Research and Material 
Command. Through such meetings, synergy in research and mutual support 
leading to the development of new drugs, vaccines, and diagnostic tests 
for the nation are achieved. My staff also holds meetings periodically 
with the Defense Threat Reduction Agency and the Defense Advanced 
Research Projects Agency, two important entities within the research 
infrastructure in the DoD.
    At the highest level, coordination of biodefense research is 
carried out by the White House, and in particular the Homeland Security 
Council, now led by Frances Townsend, and the National Security 
Council. In addition, the Committee on Homeland and National Security 
of the National Science and Technology Advisory Council also 
participates, especially through its Weapons of Mass Destruction 
Medical Countermeasures Subcommittee.
    Although these three levels describe the basic structure through 
which the Nation's biodefense research programs are formally 
coordinated, NIH, as the lead biodefense research agency, 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 biodefense research is carried out across the U.S. government.

Threat Assessment and the Research Response
    We developed the NIAID Strategic Plan for Biodefense Research and 
the two research agendas based on an overall threat assessment 
formulated by CDC in close cooperation with the intelligence community. 
Category A agents are the most dangerous microbes and toxins; these 
include anthrax, smallpox, plague, botulism, tularemia, and hemorrhagic 
fevers caused by viruses such as Ebola. 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. They are agents that a) are moderately easy to disseminate, 
b) result in moderate morbidity and low mortality rate, 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 morbidity and 
mortality rates and major health impact.
    To receive information about new threats that may arise, we work 
closely with DHS, which provides threat assessments concerning issues 
germane to our research. Because new infectious disease challenges 
emerge naturally on a regular basis, NIH has considerable experience in 
rapidly mobilizing research resources to confront new infectious 
disease threats. This experience serves us well when called upon to 
adjust our research priorities in response to new intelligence 
information.
    In closing, I am confident that the biomedical research agenda we 
have formulated concerning potential agents of bioterrorism is well 
conceived, and will rapidly lead to new and improved medical 
countermeasures against agents of bioterrorism. I am also very pleased 
with the degree of coordination and cooperation between NIH and other 
federal agencies involved in carrying out biodefense research.
    I appreciate this opportunity to testify before you today, and I 
would be pleased to answer any questions that you may have.

    Chairman Cox. And I would like at this point to welcome our 
accompanying witness, Dr. William Raub, principal deputy 
assistant secretary for public health emergency preparedness at 
the Department of Health and Human Services. We understand that 
you will be available to take member questions as a member of 
this panel. Members are advised that there are two votes on the 
floor, a motion to construct conferees on the highway bill, and 
the Cox resolution concerning human rights in the Peoples 
Republic of China. All members are encouraged to vote aye on 
that. We will return as quickly as we can upon the conclusion 
of votes on the floor.
    [Recess.]
    Chairman Cox. Welcome back. Our members will be returning 
episodically from the floor. The committee is reconstituted.
    I will begin with my questions for the panel by thanking 
you for your outstanding testimony and for being with us today 
on a very important topic. The Department of Homeland Security, 
Department of Health and Human Services, and the Department of 
Defense, as we just heard, are working together to establish a 
joint research facility at Fort Detrick, National Interagency 
Biodefense Campus.
    For the record, may I ask which agency of the Federal 
Government is in charge of this?
    Dr. Albright. Can I take that? Okay.
    Chairman Cox. Whoever answers the question.
    Dr. Albright. Whoever goes first, I guess, gets the ticket. 
Yes, we are in charge. I think what the National Biodefense 
Campus is really aimed at doing is providing a venue where each 
agency that is operating within the confines of its running 
lanes, for example, the responsibilities that have been 
assigned to it by the national biodefense strategy, for 
example, can operate in a collaborative environment. So I think 
it's a mistake to say that any one person is in charge of the 
campus. So, for example, we are in charge of NBACC, Dr. Fauci 
has responsibilities for what NIAD is operating up there, and 
General Martinez-Lopez will be responsible for USAMRIID, and of 
course works within the U.S. Army for the facility that 
actually will house the site.
    The idea behind the campus is that you have several groups 
of people at USAMRIID, at NBACC, and at NIAD who are addressing 
different aspects of the bioterrorism problem. And, therefore, 
it is important, and in our view, beneficial to have an 
environment where these people are eating together in the same 
cafeteria, their kids are in the same day care center, they are 
going to the same seminars, there are some potential shared 
assets such as animal facilities, for example, that you know 
can avoid duplication.
    But, basically, when we talk about the Center, it is really 
aimed at promoting a professionally collaborative environment 
where, again, people who are working different parts of the 
problem can freely intermingle and share ideas.
    Chairman Cox. Is USAMRIID providing the technical staff to 
support the DHS capability, or is DHS providing its staff and 
only utilizing the laboratory space?
    Dr. Albright. What is happening right this second is we 
provide staff, but we are utilizing USAMRIID space. As you are 
well aware, we have a construction proposal in our 2004 and 
2005 budget to actually build a building that would be right 
across the street from USAMRIID, but right now we are utilizing 
USAMRIID spaces.
    Chairman Cox. Perhaps then I should have asked if you could 
very succinctly summarize the roles of these three agencies in 
a sort of one-line mission statement.
    Dr. Albright. Okay. NBACC's primary--the Department of 
Homeland Security's primary function up there is threat 
characterization and assessment. NIAD, of course, conducts 
fundamental research and development activities. USAMRIID does 
much of the same, but is focused on the warfighter. And I would 
invite--.
    General Martinez-Lopez. Mr. Chairman, if I may, also the 
Department of Agriculture is part of the partnership, and they 
bring about some of the knowledge on the crop pathogens which 
also can be--agroterrorism is part of the biothreat. And they 
are looking, and some of the technology and some of the basic 
science is very similar. So what we want to do is leverage all 
the knowledge from all the four partners, and also NCI. Even 
though, you know, the National Cancer Institute is really just 
looking at cancer and treatment and that kind of stuff, but 
they are developing vaccines against cancer, they are 
developing new basic science and understanding of how cells 
behave. And that knowledge is critical to us. And so having all 
that knowledge, all the--science still is about people, sir. I 
mean, science is not about technology, science is about great 
scientists that are doing the discovery and putting it in that 
context. So if you create the right environment for them to 
really collaborate and talk and share the knowledge, I think we 
can advance that much further.
    Chairman Cox. If there is no other comment on that, open 
opportunity to comment, then let me ask about NBACC, the 
National Biodefense Analysis and Countermeasure Center, which 
has been established within the S&T directorate to be the 
operationally focused technical biodefense analysis center 
within Homeland Security.
    First, how is DHS organizing NBACC to fulfill this mission? 
Second, what is the gap in biodefense capabilities that NBACC 
is filling?
    Dr. Albright. I hope I can answer both those questions at 
the same time by telling you how we are organized. There are 
sort of two key capabilities that will be developed at NBACC. 
There is something called the National Bioforensics Analysis 
Center. This is a capability that we are doing jointly with the 
FBI. The original motivation for it was the fact that after the 
anthrax attacks, the FBI needed a place to do analysis on 
contaminated mailboxes and that sort of thing. So there was a 
need to have a national capability to analyze, to be able to 
hold and analyze evidence that is collected associated with 
bioterrorism, and ultimately to perform the appropriate 
analysis so that we can attribute the attack. And that of 
course is a very technical area that doesn't really exist in 
the Federal Government today, or it exists in a fairly 
disconnected way.
    The second key capability is the biological threat 
characterization center. And what it will do is conduct 
laboratory experiments and studies to fill important gaps in 
our knowledge regarding the risks from specific high 
consequence pathogens. For example, one might be concerned 
about the reality behind certain emerging threats, engineered 
pathogens, for example. It is important to be able to do 
experiments to verify whether or not these pathogens in fact 
can be engineered without affecting their function. So, for 
example, one might be concerned about a particular threat and 
doing a genetic modification to it that increases its virulence 
in some manner. These are living organisms, after all, and you 
just don't fool around with the genes of these things without 
having impacts elsewhere.
    It may be possible to do such a thing, but it also has an 
effect on its liability and nature, for example, or in your 
ability to weaponize it, or on a whole lot of other factors.
    So a large part of what this center is intended to do is 
provide an environment where we can do sensitive work like 
that, to first analyze and understand what the potential 
emerging threats are. And that is, of course, an analytic 
effort. It is paper studies and that sort of thing. And then, 
if necessary, to understand the realities of those threats so 
that the people who generate the medical countermeasures at 
NIAD, for example, can respond appropriately.
    Chairman Cox. I thank you very much. My time has expired. I 
have other questions on biowatch, biosurveillance, basic 
research, and so on, and possibly I will get a chance to ask 
another round. But at this point, I yield to the Ranking 
Member, the gentleman from Texas, Mr. Turner.
    Mr. Turner. Thank you, Mr. Chairman.
    Dr. Fauci, you know of my interest in trying to shorten the 
drug and vaccine development timetable. And I have also shared 
with you my concern, which I know you share, about the trends 
in the pharmaceutical industry away from production of 
antibiotics toward the more lifestyle drugs that are more 
profitable. Give me some sense of the kind of investments 
through your grant programs or internal activities, the degree 
and the amount of emphasis that we are placing on trying to 
shorten this drug development, vaccine development time frame, 
which I believe is so vital to dealing with the bioengineered 
threats that we know will be out there in the future.
    Dr. Fauci. Yes, thank you for the question, Mr. Turner. The 
issue of the development of new antibiotics, particularly 
antibiotics against drug-resistant microbes, is a threat that 
really transcends biodefense and is involved even in our 
natural interaction at the level of treating people at 
hospitals. The NIAID has a major investment in antibiotic 
development, particularly in the arena of antibiotic resistance 
to the tune of in fiscal 2005 an estimate of about 185, $187 
million.
    I look upon this in the same manner as we discussed on 
several occasions regarding other countermeasures, where there 
is a push and there is a pull. And the push is the amount of 
investment that you put into research to identify new targets. 
One of the things that we have invested in--and the biodefense 
research agenda has really enabled that--has been the ability 
to rapidly sequence microbes, things that took a year and a 
half years ago, now you can do in a day or two. And that allows 
you identify the various multiple targets of vulnerability for 
an antimicrobial.
    So the investment in basic research allows us to do that. 
The problem that we face, as you yourself just mentioned, is 
that the companies that are involved in the actual making of 
that antibiotic have other fish to fry many times. They have 
other drugs to make that people will use for a lifetime as 
opposed to an antibiotic which most courses are 10 days to two 
weeks, and then you stop using it. Or, there is the development 
of resistance, which makes that antibiotic ultimately unusable.
    Dr. Fauci. We have also enhanced and made available our 
clinical trial networks to be able to have those companies use 
our networks to test drugs. What we don't have--and are working 
towards--is to develop the same sort of positive incentives for 
companies to get involved in an arena of development that is 
not intuitively profitable for them, and the ways that we have 
done that is to try and partner with them to give them the 
comfort that we will be with them in the long run. We will 
partner to try and push the process of research and development 
further towards the actual advanced development so that their 
risk in getting involved is somewhat decreased, around the same 
broad general philosophy of what we are trying to do with 
Project BioShield.
    Mr. Turner. How much would you say that we are investing 
today in that effort to push that issue forward in the same 
manner that--we obviously have made a tremendous investment and 
commitment financially in BioShield to take care of the end. 
How much are we investing right here in the middle where we 
need to, I think, make an investment and have, I hope, national 
commitment to get this done?
    Dr. Fauci. We are progressively now, over the last year and 
a half, putting a relatively larger proportion of that $185-
some-odd million that we spend on antibiotic development to 
push into that. I can't give you a specific number except that 
when we do our projected planning of what the portfolio is 
going to look like, we are ever torquing more towards pushing 
it towards that development. So we don't have a number, but we 
are gradually being able to do that over the past year and a 
half to 2 years and will continue that in the future.
    Mr. Turner. So it seems we may have a little time to deal 
with this, but the uncertainty of it tells me that this is 
clearly an area where we need to stay out in front and on the 
cutting edge. And I don't know, General Martinez, if you can 
share with us if there is any similar effort going on within 
the Department of Defense to be able to do this. Do you have a 
parallel effort to the ones that Dr. Fauci refers to within 
DOD?
    General Martinez-Lopez. Sir, actually we do. But the good 
news is that we are in partnership with NIH. So the effort is a 
joint effort trying to--it is not compete the same industry--
trying to foster the total industry forward. So from my view, I 
am talking more from the tactical level, but what I see is that 
there is really an effort in the Department, in the two 
Departments, to really advance this cause, and it is a concern 
to both of us.
    Mr. Turner. Thank you. I think my time is up.
    Chairman Cox. The gentleman from Connecticut, Mr. Shays, is 
recognized for, if I am not mistaken, 8 minutes.
    Mr. Shays. Thank you very much, Mr. Chairman. And, 
gentlemen, welcome, and thank you for your service to our 
country.
    I want to know how do you keep biodefense research and 
procurement in sync with the threat? I see four blank faces, 
and I am going to start with whoever wants to jump in. The 
question is how do you keep biodefense research and procurement 
in sync with the threat? The threat exists right now. I am 
hearing that some things will not be resolved for 9 years, and 
I want to know how we get it more in sync.
    Dr. Fauci. It is an iterative process of modifying your 
research direction, but there is a fundamental basic research 
endeavor that really translates to any threat. Let me just give 
you an example. The example of the sequencing of virtually 
every microbe on the threat list, more than one strain of every 
microbe on the threat list. This allows us to respond to the 
possibility of there being a deliberate mutation, a deliberate 
genetic modification of that microbe. We have a given threat 
list. Sometimes a countermeasure will take years. We try to 
close that window as much as we possibly can, but we can't do 
the impossible. Sometimes things just take a couple of years. 
But if you look at the threat assessment that we had in front 
of this committee a year ago when we were talking about the 
vulnerabilities with smallpox, with Ebola and with anthrax and 
look a year later, I would say, Mr. Shays, that the amount of 
progress that has been made to close the gap of that threat is 
the fastest that I have ever seen in any public health 
endeavor.
    And we continually reassess the threat assessment, as I 
mentioned in my opening statement, by our partnering with the 
Department of Homeland Security which keeps us reassessed of 
whether the threats are changing.
    Mr. Shays. I would like to hear answers from others. Thank 
you for your answer.
    Dr. Albright. I guess I would make the same point Dr. Fauci 
made, and that is I think there is a fairly clear understanding 
of the threat, and as he pointed out we work closely with him 
as the threat evolves, but you cannot--to say it perhaps more 
succinctly, you can't command science, you can't deliver things 
instantly. So there is a certain amount of research that is 
required to develop countermeasures, and that just takes time 
to do.
    Mr. Shays. Anyone else? The answer is the same?
    General Martinez-Lopez. Yes, sir.
    Mr. Shays. The issue of botulitum antitoxin, how far are we 
away?
    Dr. Fauci. We have botulism antitoxin. We don't have enough 
for a massive attack. There are two avenues that are going on 
simultaneously. One are the stores that were actually under the 
purview of the Department of Defense of horse plasma that has 
been converted to--.
    Mr. Shays. I am just curious to know how far are we to 
having the supplies that we need for a serious outbreak?
    Dr. Fauci. It would probably take--right now if there were 
an attack involving thousands of individuals, we have enough 
right now. If there is an attack that involves hundreds of 
thousands of individuals, we are probably a couple of years 
away from that.
    Mr. Shays. More than 2 years certainly?
    Dr. Fauci. Yes.
    Mr. Shays. Three, four, five?
    Dr. Fauci. I would say probably around 3 to 4 years away 
from that.
    Mr. Shays. I had heard 9 years; so that is inaccurate?
    Dr. Fauci. Again, the question gets asked in multiple 
different way ways. It really depends if you are talking about 
enough to feel comfortable that in even the most massive 
threat, then you are talking 9 or 10 years or maybe even 
longer. If you are talking about expanding it to the point 
where we have a reasonable level of comfort that even a 
modestly big attack you can go to, then I think you are talking 
3 to 4 years.
    Mr. Shays. Why aren't we on three shifts to deal with this 
issue? I mean, really, why aren't we on three shifts? Why is it 
going to take 2 to 3 years to basically deal with the threat? 
And I want to know why we aren't having people who work 24 
hours a day, three shifts, just get it done? Is there an 
answer?
    Dr. Fauci. I think the answer is the reality of the 
situation of the prioritization of things that need to be done 
right now, given the manpower that is involved, given the 
resources we have, I think if we did that there might be a 
disproportional amount to a real threat, but one of many 
threats. So I would like to see--I mean, as someone who is 
involved in the research on this, I would have to say if I had 
my way, as it were, and you can never have your way all the 
time, I would have 24-hour shifts on everything.
    Mr. Shays. But with all due respect, that is what your 
testimony should be. Your testimony should be before this 
committee, this is what we need. If we don't deliver, then it 
is our fault. If you don't tell us, then it is your fault. And 
I know you have a tremendous task, but I have had 50 hearings 
on the terrorist threat in my subcommittee, and I am surprised 
that we seem to think it is a 9-to-5 kind of effort, 2 to 3 
years. If it is a serious outbreak, 4 to 5, maybe 9. It doesn't 
make me feel very comfortable.
    One of the things that I am uncomfortable about is there is 
a lack of interagency cooperations and communications between 
DHS, DOD, HHS, CDC, NIH, as it relates to this issue of 
BioShield, and I want to know what is going to break through so 
we don't have people going in different directions. What does 
this committee need to do to force you to have better 
interaction?
    Dr. Albright. I guess I am not sure how much better we 
could interact than the way we do. We have multiple 
coordinating mechanisms that exist. For example, in BioShield 
in particular, there is--as the legislation was being proposed, 
the way that we set up a medical countermeasures working group 
with a number of activities designed around prioritizing and 
even developing procurement strategies for the various 
pathogens of interest. So, for example, I co-chair with HHS the 
procurements acquisitionSec. 
    Mr. Shays. Is it your testimony that you disagree and that 
there is very good coordination? Is that your testimony?
    Dr. Albright. Yes, it is.
    Mr. Shays. Because we are going to have testimony that says 
that is not true.
    Dr. Albright. I would say there is excellent coordination. 
In fact, I see Tony at least once a month, I would say.
    Mr. Shays. Is that a lot?
    Dr. Albright. For senior leadership to run into each other? 
Yes, sir, I would say so. I have people on my staff who 
interact with HHS on a daily basis.
    Mr. Shays. Why does DOD, General Martinez-Lopez, pursue its 
own efforts, separate from HHS, that parallel; and why is it 
that DOD does not have to have the same regimen dealing with 
children and the elderly that we require from HHS?
    General Martinez-Lopez. Sir, let me see if I got the 
question right. When we develop a vaccine, are you saying that 
we don't have the same requirements for children?
    Mr. Shays. Right.
    General Martinez-Lopez. We are trying to get the FDA 
approval, and if this is a strategy that is unique to the 
Department of Defense, that it is going to be only used for 
warfighters, then obviously the FDA may only license that 
product for an age group, both males and females. But quite 
often, like with--but right now as we move into the future, 
sir, many of the products, for example, the RPA, the next 
generation anthrax vaccine, one of our products has been--.
    Mr. Shays. General, let me be clear, though. What you 
develop is not just for the military.
    General Martinez-Lopez. Correct.
    Mr. Shays. And what makes me nervous is you don't follow 
the same regimen, and yet in the end what you do may be used 
for elderly and children.
    General Martinez-Lopez. The good news, sir, is right now, 
as an example, the RPA vaccine, that is a new generation 
anthrax vaccine, was developed initially by the Department of 
Defense. Now it is being followed by NIH, and when it is 
licensed it is going to be licensed for both, for general 
population. So this is an effort where the interagency--in the 
old days, the Department would have followed probably just a 
warfighter FDA licensing. Now we are going to be looking at a 
more general population licensing because the interagencies are 
working on those issues. There will be countermeasures that 
will be unique to the Department of Defense because their 
strategy may be different the way we approach a particular 
disease. In those cases I don't know how we are going to pursue 
that--.
    Mr. Shays. I would thank you all for your service. I know 
you are trying to do the best you are doing. I just would 
conclude by saying when I hear 2 or 3 years, if there is an 
outbreak before, the question that is going to be asked of us 
is, why wasn't this an around-the-clock effort? And it isn't. 
And that is what of concern.
    Thank you, Mr. Chairman.
    Chairman Cox. The gentleman's time is expired.
    The gentlelady from the Virgin Islands, Dr. Christensen, is 
recognized for 8 minutes.
    Mrs. Christensen. Thank you, Mr. Chairman. And welcome to 
the panelists.
    I share some of those concerns, and when other areas' 
directors, agencies, come before this committee, we are always 
very concerned with, one, the slow pace of the readiness and 
preparedness, the often lack of clear lines of responsibility 
and the lack of institutionalized coordination. We hear about 
coordination that takes place, but it seems to be very informal 
and dependent on the people in place, and we would like to see 
that more concretized so we know that it will continue 
regardless of who is there and who is working in these areas.
    Dr. Fauci, I promised you a question, because we have 
gotten into this before, during the BioShield hearings. Do you 
have any indication from within the Department that the same 
emphasis that is being placed on research is being put in the 
public health preparedness and any thoughts on just how 
effective all of this wonderful research can be and the 
wonderful counteragents deployed and utilized when they are 
needed, if our public health infrastructure, the facilities, 
the staff, the training, is not adequate and in place?
    Dr. Fauci. Mrs. Christensen, I could answer the research 
part, but I would have to ask Dr. Raub to answer the public 
health preparedness, because that is not something I am 
responsible for. The research is going at a very rapid rate and 
I might, if you would allow me to, just comment about what was 
just said by yourself, saying the slowness of the pace and what 
Mr. Shays mentioned about--.
    Mrs. Christensen. Coordination.
    Dr. Fauci. How can we increase this pace.
    Mrs. Christensen. Not too long, though.
    Dr. Fauci. No. It is going to be real short. When you are 
doing research, there are things you can't push because the 
science doesn't go to your demand. And that is something that 
really needs to be understood. You can't demand the science to 
give you a discovery.
    The other thing is that even when you are making a product, 
for example, botulism antitoxin, there are two ways to make it. 
You vaccinate a horse or you try to develop a monoclonal 
antibody. A monoclonal antibody takes years to develop and to 
develop correctly. You vaccinate a horse, it takes 3 to 4 
months before the next boost, another 4 to 5 months before the 
next boost, and another 4 to 5 months before the next boost 
before you get a titer even high enough to bleed the horse. So 
you could stand there and watch that horse 24 hours a day, but 
it is not going to have that horse make antibodies anymore 
quickly. So there are constraints that we have.
    Mrs. Christensen. I will come back to that, too. But go 
ahead, Dr. Raub, please.
     Mr. Raub. Thank you. The emphasis on strengthening State 
and local public health preparedness is every bit as high a 
priority as the investment in research and development. We have 
a program of cooperative agreements with all of the States, 
some major cities, and the territories. One part of that flows 
through the Centers for Disease Control and Prevention, aimed 
at State and local health departments. The other part flows 
through the Health Resources and Services Administration, 
focused on hospitals and other health care entities.
    We have provided a little over a billion dollars in fiscal 
year 2002, about $1.5 billion last year, and we will award 
about another $1.5 billion this year. In shaping those 
cooperative agreements, we have tried to balance broad 
investments, strengthening public health overall, such as the 
addition of epidemiologists, the improvement of communication 
systems, the improvement of laboratories, with things that are 
highly specific either to bioterrorism or other aspects of 
public health emergencies, and we will continue that emphasis. 
We are gratified by the strong response of our State and local 
partners, and it will continue to be a major emphasis for us.
    Mrs. Christensen. The administration has requested $150 
million less for public health and hospital preparedness grants 
for fiscal year 2005. How can we justify cutting? I also 
notice, I think I read this week that $480 million was just 
released for hospitals, and you said at one point $5 billion. 
Have the States and territories indicated what their level of 
funding need might be, and how well are we meeting what they 
have projected their needs are? Because my understanding is 
that in the hospitals and emergency rooms the staffing is 
really overstretched, and maybe there are two States out of the 
whole Nation that can be considered relatively prepared.
    Mr. Raub. I think it is fair to say that, if asked, every 
one of our State or local colleagues would say that, if more 
moneys were available, they could use it intelligently. 
Nonetheless, substantial investments are being made and much of 
that is at a pace or above what many of them are able to 
accommodate because of limitations in their procurement 
systems, hiring freezes, and the like, and we have continued to 
work with them to try to accelerate some of those investments.
    Looking to the future, the fiscal 2005 budget proposes a 
continued substantial investment. Some of the offset you 
described is not to take it away from the problem but rather to 
orient it on another facet; namely, increasing our capabilities 
for biosurveillance as well as increasing our capabilities for 
quarantines. So it is a matter of the typical set of choices 
that go along with the development of any budget, but we 
believe the aggregate package continues to be strong and will 
remain among our highest priorities.
    Mrs. Christensen. Dr. Fauci, you talked about the long time 
frame to developing vaccines, that it is relatively long, we 
can't just demand and it is going to be there. In light of 
that--and we have talked about BioShield--we have had many 
hearings on that--our Ranking Member mentioned fast cures. 
Wouldn't it be better for us to focus more of our time and 
investment on more basic, more generic all-hazard type research 
to shorten the time frame to develop a countermeasure, rather 
than, as we are doing in BioShield, preparing to meet agents, 
some of which we know or we think are likely to be agents, some 
of which we have no idea on, so when a new agent shows up, we 
are not going to be able to respond quickly enough to develop a 
countermeasure? Wouldn't it be better for us to focus on the 
fast cures approach?
    Dr. Fauci. The fast-cures approach can be either specific 
for a microbe or it could be more generic. In fact, at the 
testimony last year, I introduced a concept--and we are 
following up on that--of trying to develop much more generic 
antimicrobials against a whole range of microbes, as opposed to 
going through each individual specific microbe.
    The same holds true for vaccination to be able to more 
generically or globally up-regulate the body's immune system by 
dealing with the innate immune system so that it could respond 
across a wide range of microbes.
    I do agree with what Mr. Turner said, that we should try, 
particularly with the combination of both screening and then, 
as soon as you get a ``hit'' as we call it, to try to develop 
very rapidly at least a couple of antimicrobials against all 
the known threats and use your knowledge of the genomic makeup 
of the microbes to be able to target.
    So there are two general approaches that I believe Mr. 
Turner was referring to. One is a screening approach, which is 
more amenable to the rapid approach that he is talking about. 
And then there is the targeted development, which may not be as 
rapid but ultimately would also get you good results. I think 
if you accelerate both of those, the time frame from when you 
started until the time that you actually have a countermeasure 
against a microbe will be shortened.
    Mrs. Christensen. Is that 8 minutes or 5?
    Chairman Cox. That is 8 minutes. The gentlelady's time is 
expired.
    Mrs. Christensen. Okay. I will be back. Thank you.
    Chairman Cox. The gentleman from Washington, Mr. Dicks, is 
recognized for 5 minutes.
    Mr. Dicks. The gentleman from Connecticut, Mr. Shays, 
pointed out that if we were truly treating this as a wartime 
setting, we would be going 24 hours a day. I can remember in my 
hometown of Bremerton, Washington when they were overhauling 
and repairing ships during World War II, that they went 24 
hours a day, 7 days a week. The President came out there twice 
to exhort the workers to do more, to do it faster, to restore 
these ships that had been damaged to the Pacific fleet. And I 
too share Mr. Shays' concern that this is a very leisurely pace 
that we are talking. And the cutting of $150 million for these 
grants again is a demonstration. Can anybody here tell us that 
public health agencies across the country and hospitals are 
prepared to deal with a biological attack of some sort? I 
certainly don't hear that from my doctors and from my clinics 
out in the State of Washington. We probably do better because 
we have a few military hospitals there, Madigan and Bremerton 
Naval Hospital, but I share this same concern that we are doing 
this at a one-shift-a-day approach. And I just wonder whether 
we are going to get this job done and get the country truly 
prepared.
    There was one question here I am going to ask all of you. 
What are the two or three largest obstacles to true terrorism 
preparedness in the United States? I would like each of you to 
take a shot at that. Is it money? Is it commitment? What is it? 
The Congress? What is blocking you from moving out and getting 
this job done?
    Dr. Fauci. From a research standpoint--and I would like to 
in my answer very briefly address your justifiable concern, Mr. 
Dicks, about the slowness of the pace--if we had a product that 
we needed to make available by manufacturing it, then you put 
the 24-hour shifts in and make it.
    During World War II they were making bullets, they were 
making tanks. They knew how to make the tanks. When you are 
dealing with research, there are questions that need to be 
answered and knowledge that needs to be gained that isn't 
necessarily as amenable to the 24-hour approach. Once you get a 
product, then I say put the afterburners on and go after the 
24-hour approach.
    So my part of the answer to your question to the four of us 
is that when you are dealing with research, knowledge is one of 
the major stumbling blocks, and that is why you do research to 
develop the concepts so that you can get the countermeasures. 
So from my standpoint that is it. We have been given--.
    Mr. Dicks. So the biggest obstacle from your perspective is 
a lack of knowledge on how to prepare the countermeasures that 
we need?
    Dr. Fauci. Precisely. From a research standpoint. I am not 
talking about public health. Others can answer that. But from a 
research standpoint, it is our race to get the knowledge to be 
able to develop the countermeasures that we don't have.
    Mr. Dicks. Dr. Raub.
    Mr. Raub. Complementing that on the public health 
preparedness side, I would say the greatest challenge is 
getting and keeping agreement on the threats and priorities of 
the threats. I will give you an example of that. When we began 
our investments 2 years ago in the increased State and local 
preparedness, one of the benchmarks we set out and asked all of 
the States to address was to have an epidemiologist for every 
municipal area within a State that had 500,000 or more people. 
Virtually every one of the States has achieved that because 
they and we agree that it is fundamental to public health 
preparedness.
    Other aspects such as the ability to receive an emergency 
case report around the clock, 24-7, has been aggressively 
implemented by some States but not others. And I think it is 
not so much they don't know how, but rather they don't perceive 
the emergency threat in the same way that other States do, or, 
frankly, to the degree that some of us do.
    So part of our continuing challenge is trying to ensure 
that communication to get the emphasis on both broad 
enhancement of public health but also the more sharpened aspect 
of emergency response. And that is a continuing challenge, 
especially the further you are outside the Beltway, and 
sometimes the threat doesn't seem as acute, and we will 
continue to labor at that.
    Mr. Dicks. General?
    General Martinez-Lopez. Sir, I think I agree with Dr. 
Fauci. But something else that is a second-level obstacle is 
sometimes we rely--we have labs all over the country, and the 
way the scientists go about their business is by reading the 
articles that are published. It takes us almost a year or 2 
years to publish those articles. In order to compress the 
cycle, what you want to do is to bring those guys together, 
either to conferences, or, like in the biodefense campus, to a 
single place where now, having coffee, they can discuss a 
particular project or a particular problem they have, and that 
way you can compress the cycle.
    And I think one of the things that the biodefense campus is 
going to allow us to do is exactly that: Bring different 
agencies, different people approaching the same problem from 
different angles, and put them together. And we hope that by 
doing that alone, obviously we are going to foster more 
structure collaboration, but by doing that we can really 
compress the cycle and, at the other end, with better products.
    Mr. Dicks. Secretary Albright?
    Dr. Albright. I think I agree with Dr. Fauci's point as 
well. And I think the basic obstacle fundamentally is time. I 
think it is not resources. I think this administration has 
devoted fairly significant resources over the last couple of 
years to basic research, to threat characterization, to 
procurement of countermeasures should they be available. I 
think the real issue is having the time to develop and the 
knowledge to develop those countermeasures, making the research 
work.
    Where we have countermeasures, we are, I think, to use your 
term, we are going 24-7. A good example is the very first 
procurement that is going to come out under the BioShield is 
the RPA procurement, and in the meantime we are maximizing--as 
part of that we are going to maximize production of the AVA 
vaccine, the existing vaccine, until RPA comes on board. So I 
think you cannot command discovery, as I think Dr. Fauci said, 
and I think that is the real issue.
    Mr. Dicks. Thank you.
    Chairman Cox. Mr. Langevin is recognized for 5 minutes.
    Mr. Langevin. Thank you, Mr. Chairman.
    And, gentlemen, I would like to thank you for 
participating, being here today. Certainly your insights and 
expertise have been extremely helpful as we wrestle with some 
very difficult issues.
    In particular, I just want to welcome Dr. Raub here today, 
with whom I had the pleasure of participating recently in a 
recent exercise of the National Defense University where 
Members and agency experts were confronted with a disturbing 
scenario involving multiple bioweapons attacks across the 
country. So thank you for being here. The exercise that we were 
involved with was certainly enlightening and provided a rather 
chilling reminder of how far we still have to go to ensure that 
we are adequately prepared to respond to such an attack.
    One of the problems that we confronted during the exercise, 
which involved multiple, nearly simultaneous anthrax attacks on 
various cities, was determining how to allocate limited 
stockpiles of drugs when there may not be enough for every 
person affected. In addition, it became clear that finding 
adequate personnel to distribute the drugs once they arrived 
and appropriate locations for distribution would be a major 
hurdle.
    So what I would like to ask is, in terms of stockpile, can 
members of the panel address adequacy of our current stockpile 
and what plans, if any, are in place to increase it so that we 
would have sufficient product on hand in the event of multiple 
simultaneous attacks or even one attack of great magnitude? And 
also has consideration been given to working with Canada and 
other countries to quickly get additional drugs to the right 
place should the need arise?
    Mr. Raub. Thank you, sir. I will start off, and others may 
want to add here. The current Strategic National Stockpile--and 
I will focus specifically on antibiotics not only because that 
is the major part of it but that was the focus of the exercise 
in which you and I and others engaged--that stockpile is enough 
for 13 million individuals for a 60-day course of treatment. 
Plans are underway beginning this year and going through fiscal 
year 2006 increase that stockpile to the order of 60 million 
treatment courses for 60 days, recognizing that we need a 
broader capacity.
    Mr. Langevin. That will take place over how much time?
    Mr. Raub. Between through now and fiscal 06 as our 
proposals are considered.
    The second part of that, as you indicated, is one of our 
weakest links right now is getting the material from the 
airport or wherever we deliver it into people's mouths. All of 
our public health components around the country know how to set 
up and operate a point of dispensing, and many do it routinely 
for childhood vaccination or for outbreaks such as meningitis, 
but none of these communities has ever been challenged to do it 
on a very broad scale in a very short period of time. And it is 
our new understanding of the anthrax threat in particular, 
where an area of square miles could be covered, and we would 
not know who was exposed, but we would have to start antibiotic 
treatment while we figure that out, that becomes a major 
challenge.
    That is the thrust of this recent plan announced by the 
Department for a Cities Ready Initiative to focus on 21 major 
cities in collaboration with our colleagues in Homeland 
Security, the United States Postal Service, and others, to make 
more robust the metropolitan capability to deliver and dispense 
antibiotics locally, to supplement that with Federal resources 
as needed, including those of the U.S. Postal Service, and in 
general to get the more rapid penetration that would give us 
time to understand better the nature of the exposure and to go 
on with the longer-term public health measures.
    The final part of this is to encourage more local 
deployment of antibiotics for the immediate needs of the 
community, especially for medical personnel, for fire, police, 
transportation operators, and others--that there would be 
enough material on hand immediately to ensure some stable 
function of that infrastructure while the larger response was 
being readied.
    Mr. Langevin. Anyone else?
    Dr. Albright. Well, another issue that generated a great 
deal of discussion at the exercise was the question of 
information sharing with the public at large as well as State 
and local officials and specific industries or sectors that 
might be particularly affected. We all agreed at the outset 
that in any crisis like a bioterror attack that it was critical 
that those who needed information would receive it in a calm, 
detailed, and coordinated manner basically, obviously, to 
engender trust, minimize panic, and ensure cooperation and 
assistance of those in a position to help. What we couldn't get 
a clear sense of is whose responsibility such communications 
are going to be or are.
    My sense is that both a public information and education 
campaign as well as information sharing among jurisdictions and 
industry sectors should be coordinated through the DHS so that 
there is one clear voice speaking to Americans and one defined 
clearinghouse of information flowing to and from various 
stakeholders.
    So I would like to ask the panelists to describe their 
understanding of the procedures and protocols currently in 
place for communicating with State and local governments, the 
private sector, and the public in the event of a bioterror 
attack; and do you feel these mechanisms are adequately defined 
and understood among all relevant agencies; and is there a plan 
in place for what information to share at what time; and are 
the basic elements of a public information campaign already in 
place so that it could be quickly implemented in an emergency?
    Dr. Albright. There are several aspects to that. There is 
sharing with the local public health officials, which I will 
defer the answer to that to Dr. Raub.
    In terms of communication strategy, the department has been 
fairly proactive in developing a suite of communications 
strategies, I guess is the right word, for a wide variety of 
events--radiological, nuclear, biological--but I would say that 
is work that is just now--it is not mature yet. Exactly how to 
communicate to the public what the risk is, how to keep the 
issues surrounding--what precisely the response of the public 
should be if a particular event were to occur, for example, a 
radiological or biological attack, is something we are working, 
for example, with the National Academies on. It is an area that 
we are focused, but it is a work in progress.
    Mr. Langevin. Where along that process are you right now?
    Dr. Albright. Excuse me?
    Mr. Langevin. In terms of a timeline, where are you in that 
process to having--.
    Dr. Albright. We are proactively--as I said, we have a 
contract in place with the National Academies of Sciences to--
and I believe that has been underway for several months--to 
develop communication strategies in these various areas. I 
believe it is a 1-year contract, but I am not certain of that. 
This is actually being operated under our public affairs shop, 
and I will certainly be happy to get back to you after the 
hearing with more information on that if you wish.
    Mr. Langevin. Yes, I would like that. Thank you.
    Dr. Raub.
    Mr. Raub. If I could just add quickly that your question 
has several facets, and I won't try to touch all of them, but 
at the national level under Homeland Security Presidential 
Directive No.5, any event involving two or more of the Federal 
agencies looks to Secretary Ridge to be the coordinator of 
those activities, including the coordinator of the 
communication aspects of it.
    At the local level, those cooperative agreements that I 
mentioned in responding to Mrs. Christensen before include a 
component on public communication, and we have asked each of 
the State and local health departments to prepare themselves 
not only on their own, but in conjunction with the emergency 
management officials and their political leadership and others, 
to have the capabilities to, as you say, apprise the public 
actively in a firm but low-key way to not only let them know 
what is happening but also to enlist their cooperation; because 
if we are at a major response such as something requiring rapid 
distribution of antibiotics or vaccination of a large group of 
people, no matter how good our medical or public health 
capabilities are, if we don't have cooperation from the public, 
and instead we have civil disorder or chaos, it just makes that 
medical delivery almost impossible. Those are just two aspects 
of it but this continues to be a major concern and emphasis for 
us.
    Ms. Dunn. [Presiding] The gentleman's time has expired. I 
thank the gentleman. Next we will call on the gentlewoman from 
Texas, Ms. Jackson-Lee.
    Ms. Jackson-Lee. Thank you, Madam Chairperson. I thank the 
witnesses for their presentation as well.
    Let me try to characterize the attitude that I have or the 
sense of concern that I have, using one or two anecdotal 
stories or at least reflections on the week's recent events, 
first being the pronouncement by the Attorney General just last 
week, during the week of memorializing and honoring our fallen 
soldiers, of a terror alert or at least a terror pronouncement. 
I am not sure what it was intending to do. But for those of us 
in our communities, our local districts, it was confusing at 
best because, obviously, it was a stand-alone activity by the 
Department of Justice and the FBI Director, and only later did 
Secretary Ridge either suggest that he gave his approval--but I 
can assure you that those on the homefront, which is what I 
believe the Homeland Security Department and this committee is 
to be about, we are certainly concerned about the inside-the-
Beltway, but our work is really outside the Beltway, and really 
that announcement fell on deafened ears, jaded minds, and 
people basically ignored it. That was the context in which it 
was received.
    Just as an aside that is not really pertaining to your 
business, yesterday we were debating a constitutional amendment 
dealing with the potential of losing 218 Members of Congress, 
maybe all at one time. And the reason why I raise that with you 
is that even that monumental debate did not warrant this body 
giving it more than 30 minutes a side to talk about what would 
happen if we did not have this Congress in place or government 
in place.
    I only use these examples to say that I am equally 
concerned that many think of terror as airplanes flying into 
buildings and have not yet understood the potential biological, 
chemical, or radiological weapons, except for the fact of the 
terminology ``dirty bombs.'' At least the public understands 
that, but I don't know if they perceive that it will come in 
Cleveland, Ohio, or Houston, Texas, or some rural hamlet or 
village or suburban location.
    And that is my frustration where we are today. I think this 
is an important hearing, but I would like to raise these 
points, but I would ask any of you to join in, but specifically 
I would like Dr. Albright and Dr. Raub to answer these 
questions, and they build upon my colleagues' concern, and that 
is about our public health and hospital infrastructure. But I 
also want to speak specifically to local clinics, health 
clinics.
    Many of us are advocates of local community health clinics, 
and my concern is when you use the term ``local,'' are we 
reaching as far into the infrastructure as those local clinics?
    My first question is, enunciate for me or give me an 
understanding--and I am going to give you all the questions at 
once--what are the accountability standards that have been put 
in place? Where are they? Are they posted up on a wall? Does 
each medical director have them or public director have them? 
Do the city and county directors have them? And what is the 
guidance being given? Is there a 1-800 number or emergency 
number that someone can call to immediately grab hold onto the 
instructions? We can talk about large intent, but if they are 
not transferrable, they are not working.
    On the outsourcing do we have a firewall--when we talk 
about outsourcing, production of biodefense agents, do we have 
a firewall to protect the Nation against sabotage of production 
of those biodefense agents, or are we randomly outsourcing with 
no indication at all?
    The last question deals with what I started out with, my 
local community health clinics. Are they in any way connected? 
And I am sure you will say connected to their major body, 
whether it is State or local; but are they connected? Is there 
some way of having tentacles to that embedded community clinic 
that is somewhere in someone's community, whether it be rural 
or urban? And I would appreciate it if you can attack this 
question with a vengeance.
    Let me just for a moment--and I know I am on this last 
point here--you have a problem called BioWatch, Detect to 
Treat, and there was an incident in Houston, tularemia, where 
it did not work. I think you are aware of it, and I don't want 
to go on long with the question, but if you can comment on 
that, and if not, I will welcome that in writing. But Dr. Raub 
and Dr. Albright, and others who may want to join in. Thank 
you.
    Mr. Raub. With respect to your first question about 
accountability standards and guidance, the cooperative 
agreements that I mentioned before from both of the agencies 
include items that we call critical benchmarks. These are 
milestones on the road to preparedness, but things that are to 
receive the highest priority and things that we believe can be 
and should be achieved in a short period of time.
    Ms. Jackson-Lee. Are you speaking about standards? That is 
what I asked about, accountability standards. You are talking 
about benchmarks.
    Mr. Raub. Well, some of them are quantitative now. Others 
are our first estimate, because we are not sure exactly what 
the final standard should be. I gave the example before of 1 
epidemiologist for every metropolitan area of 500,000 people or 
more. We think that is a good starting number. We don't know 
that that is the precise standard that ought to hold for all 
time, but it was a near-term target that we believed every 
State could and should achieve, and we will continue to make 
that kind of emphasis.
    As these cooperative agreements go on, we will sharpen and 
build on those critical benchmarks, trying to make them more 
precise and more quantitative and closing in on standards, as 
you would describe it, because I share your view that we need 
to be communicating as clearly as we can about what we are all 
trying to achieve.
    With respect to the emergency response, every one of the 
State health departments is well connected to the Centers for 
Disease Control and Prevention and knows how in the face of an 
emergency or even any uncertainty to make the contacts at CDC 
to get the kind of technical assistance they need. CDC in turn 
is well connected not only with our Office of the Secretary but 
with colleagues in the FBI. We are well connected with the 
Operation Center at the Department of Homeland Security, and we 
like to think we are getting better and better at providing 
that kind of emergency assistance and response.
    Ms. Jackson-Lee. Dr. Albright.
    Dr. Albright. What I can comment on is on your question 
about the BioWatch incident in Houston. Actually I think that 
is an example of the system first working quite well and a good 
example of interagency cooperation and cooperation between 
Federal and local public health entities.
    First let me state what actually happened. The BioWatch 
system that was in Houston in fact did detect tularemia and in 
fact it was tularemia. The system did work. The pathogen was 
later sequenced at CDC and was confirmed to be that. They were 
very weak hits. When the incident occurred, what we immediately 
did was to begin coordinating with CDC in two specific areas. 
The first was in the arena of a public announcement. So in 
terms of public affairs, we worked jointly with CDC to craft 
some--frankly, some talking points for the local public health 
officials should they decide that they needed it.
    The second thing we did, very importantly, was again 
working with CDC and the local public health people, was we 
increased disease surveillance in the area. So we had these 
very weak hits of tularemia in the system. We then--CDC 
actually and the local public health authorities notified the 
local clinics to--essentially if they got a certain set of 
symptoms, to rule out tularemia was basically the instructions 
they got, and thereby substantially increased our ability to 
detect the disease, which, if detected, is eminently treatable.
    So what it was, was a very good example of our ability to 
work very closely with CDC and HHS on an event such as this. 
Then secondly, our ability jointly at the Federal level to work 
with the public health authorities locally. They were basically 
told that they were in charge of the incident, and they were 
put in charge of the incident. And I have to tell you, I don't 
think they believed it until we actually did it, that they were 
allowed to run it. They were allowed to run the public affairs 
aspects of it. They were allowed toSec.  they interacted with 
their local medical community directly.
    Ms. Jackson-Lee. They waited several days to determine that 
that was what the substance was or what the item was.
    Dr. Albright. Excuse me. What actually happened was, the 
way we get the hits in tularemia is through a very robust 
analysis. This was not a false alarm. No one thought it was a 
false alarm at the time. And all I can say is that the 
subsequent analysis just confirmed something that we really 
knew to be true on the ground, I believe the local public 
health people knew to be true on the ground as well.
    Mr. Raub. Let me just add as somebody who spent many hours 
in the Operation Center those several days, as Dr. Albright 
indicated, we had a true positive. It turned out to be 
environmental noise, not a terrorist attack, and frankly we 
thought it was environmental noise. The officials in the city 
of Houston, in Harris County in the State of Texas, could not 
have performed better in our judgment in terms of the very 
deliberate way they proceeded in the face of the uncertainty 
but the likelihood that we had something that was an 
environmental cause rather than a terrorist attack. 
Nonetheless, the surveillance efforts they put in place as a 
precaution were a model, I think, of what other cities might 
do. And from my perspective I viewed that as some of that State 
and local money at work manifesting itself in a demonstration 
that they are indeed moving to heightened preparedness.
    Ms. Dunn. The gentlelady's time has expired.
    The ranking member of the committee, Mr. Turner of Texas, 
has an additional question.
    Mr. Turner. I won't take a question because I think we need 
to move to the next panel. But I want to make a request and 
maybe, Dr. Fauci, if you could do this for us it would help us 
as a committee. You have heard people on both sides of the 
aisle talk about their sense that we are not doing this 24-7, 
that we are not making the kind of commitment that we need to 
make, and so it would be helpful to us if you could prepare for 
us and perhaps give us a briefing outside of the hearings, just 
a briefing with members that are interested and staff, on the 
total dollars that we are currently spending and the kind of 
grants and other activities that are ongoing through your 
agency and any others that you have to bring in, which I am 
sure you are aware of, to a accomplish the goals of that rapid-
cures act that we have introduced, so we can get a sense of how 
great a commitment are we making to this basic research that is 
necessary to shorten this time frame and the right options on 
how to do it.
    The other presentation I would request from you to present 
perhaps in the same fashion to the staff and the members who 
are interested in a briefing setting is the amount of money 
that we are committing to finding the countermeasures to the 
various pathogens that we know we are worried about and maybe 
do the class A, the class B, the class C. Let us just see the 
dollars that we are spending, the grants, the total efforts 
that we are making in those areas to give us a sense of that.
    And then the final one is a request that you are familiar 
with, I think, that came from staff as they were trying to look 
into the financial management review procedures that you use 
before you enter into a contract with a private sector company 
to do some work for you; because, as you know, there is some 
information out there now that this biotech company, VaxGen, 
that has over $100 million in government contracts, that there 
may be some evidence of accounting irregularities there, and I 
think they have been threatened with having their name delisted 
from NASDAQ, and it has given us concern.
    If you could provide us a briefing about that issue so that 
we can have some assurance that when you are granting these 
multimillion-dollar contracts, that we are giving them to 
companies that are not going to go bust on us.
    Dr. Fauci. I would be happy to do all three of those 
requests, Mr. Turner, and I will have my staff work with your 
staff to set up the briefing times as soon as we possibly can.
    Mr. Turner. Thank you. Thank you, Madam Chairman.
    Ms. Dunn. Thank you. And thank you very much, gentlemen, 
for appearing before us today. It has been very useful and we 
appreciate your coming here.
    The Chair would like to ask the second panel to be seated, 
please.
    We welcome our new panel. Thank you for being with us 
today. Let me remind you that if you could keep your opening 
statement to 5 minutes, your written statement will certainly 
appear in the record, and as a result we would be able to allow 
our members to have time for questioning. Thank you very much.
    Ms. Dunn. Why don't we start with Dr. Johnson Winegar, and 
then we also welcome and we will hear next from Dr. Shelley 
Hearne.

     STATEMENT OF ANNA JOHNSON-WINEGAR, PRIVATE CONSULTANT

    Ms. Johnson-Winegar. Thank you, Madam Chairman, and other 
members of the committee, for the opportunity to appear before 
you today to address this extremely critical topic that I have 
thought about for essentially most of my professional career.
    Just to set the stage, I wanted to inform you that I have 
previously served as the Deputy Assistant to the Secretary of 
Defense for Chemical and Biological Programs, and recently 
retired from that position. I do have a Ph.D. in microbiology 
and I am currently a private consultant in those general areas.
    When I think about the area of biodefense and bioterrorism, 
I feel very strongly that a comprehensive approach is required 
to address the full spectrum of things that can go on. First 
and foremost, I feel it important that we must significantly 
increase our resources in the areas of intelligence and threat 
assessment. In my opinion, unfortunately, our expertise in this 
area is indeed quite limited.
    Another important area that I think is quite overlooked is 
that of biodetectors. The current biodetectors that we have are 
characterized by the scientific community as detect-to-treat 
rather than detect-to-warn, and this is due to the lag time 
between collection of samples and identification of the 
pathogen. And while this is a good first-step approach, without 
more definitive intelligence, the cost to establish and 
maintain a sufficient number of these biodetectors throughout 
the United States is prohibitive.
    And I think that perhaps even more importantly than working 
on improvements in biodetector technology, for I do believe the 
improvements will come incrementally, is the need for a concept 
of operations. In other words, what happens when the alarm goes 
off? Who makes the decisions? Where are the supplies that we 
needed? And finally, after a potential attack, there is the 
whole problem of residual contamination and clean-up.
    I think that much more emphasis needs to be placed on new 
decontaminants that are environmentally friendly, safe to use 
on humans, and sensitive electronic equipment, ones that can be 
disbursed over large areas, ones that work quickly and are 
inexpensive.
    And, finally, any robust science and technology program 
that addresses bioterrorism and biodefense needs all of these 
aspects, plus medical countermeasures.
    Realizing the lack of a commercial market and poor 
incentives for the industry has been one of the problems in 
getting the pharmaceutical firms to develop the drugs and 
vaccines that we need. I think a lot of information has been 
provided by the earlier panels on the work that is going on in 
what I characterize as basic research, and there is the 
BioShield legislation to address the procurement of these 
items. However, I feel that there is a major gap in the 
advanced development areas. We need additional work done on 
validated animal models. We need a lot more work done in both 
preclinical and clinical trials so that before these products 
come to market, we are sure that they are both safe and 
effective.
    I would call your attention to the recent report by the 
Institute of Medicine on giving full measure to medical 
countermeasures in which they describe a number of problems 
associated with the current approach and they make specific 
recommendations for alternatives. I firmly believe that a 
vigorous effort must be made to shorten the time frame to 
develop new medical countermeasures.
    Clearly the Department of Defense has invested for many 
years in the area of medical countermeasures. Now the budget of 
the Department of Health and Human Service has increased 
dramatically, now providing over $1-1/2 billion. This indeed 
dwarfs the investment made by the Department of Defense, and it 
has initiated an obvious shift from DOD to HHS as the primary 
funder in biological research against terrorists' use of 
biological agents.
    However, the history of NIH has been one of investigator-
initiated research rather than one that is based on threats or 
driven by requirements. While the NIH has traditionally been 
strong in basic research, they have much less attention on 
product development and licensing of new products.
    I think that we all agree that bioterrorism is a major 
threat to us, and I think the priorities need to be established 
across the various Federal agencies, all the way from analysis 
of the threat and a true prioritization of the vast array of 
projects that could be funded. Not every project of purely 
scientific interest deserves funding. Measures of effectiveness 
must be established and publicized. Areas of common interest to 
the individual departments must be leveraged to shorten the 
timelines. Formal communication and collaboration must be 
established that transcends the particular individuals involved 
in the programs. Budgets must be aligned. Senior officials must 
be held accountable, and results are imperative.
    I would be happy to answer any questions that the committee 
members may have.
    Mr. Turner. [Presiding] Thank you, Dr. Winegar.
    [The statement of Dr. Winegar follows:]

             Prepared Statement of Dr. Anna Johnson-Winegar

INTRODUCTION
    Mr. Chairman and distinguished committee members, I am Dr. Anna 
Johnson-Winegar. Thank you for the opportunity to appear before you 
today to address this extremely critical topic. I am the former Deputy 
Assistant to the Secretary of Defense for Chemical and Biological 
Defense Programs, having served in that position from October 1999 
until my retirement in June 2003 after 37 years with the Department of 
Defense. I have a PhD in microbiology and I am currently engaged in 
private consulting in the general areas of chemical and biological 
defense, biotechnology, medical product research and development, and 
other related areas for both government and commercial clients.
     I am here today to discuss my thoughts on how the United States is 
proceeding toward developing a comprehensive biodefense strategy. I 
think we are all aware that the tragic events of September 11th and the 
anthrax cases in the fall of 2001, as well as more recent incidents 
with ricin have greatly heightened the public's awareness of the threat 
of biological terrorism. The creation of the department of Homeland 
Security last year was a major step in raising the level of importance 
of all aspects of security for the people of the United States. The 
focus of today's hearing, and the basis for my remarks deals 
specifically with the threat of bioterrorism- one aspect of the broader 
threat of weapons of mass destruction (WMD).

A COMPREHENSIVE APPROACH IS REQUIRED
    When addressing the full spectrum of a potential attack with a 
biological agent, it is helpful to identify responses across a 
continuum. Clearly, long before any such incident, we must 
significantly increase our resources in the areas of intelligence and 
threat assessment. Unfortunately, our expertise in this area is quite 
limited. While there have been modest efforts to capture information 
from employees who worked in the U.S. offensive biological warfare 
program that was cancelled by President Nixon in 1969, much of their 
understanding of how to make a biological organism a weapon has been 
lost. Among the goals of the National Biodefense Analysis and 
Countermeasures Center (NBACC) is support for intelligence activities 
and characterization of biological threats. This will take years of 
hard work to establish core capabilities and build a strong cadre of 
personnel. This group will also be challenged by the need to think 
creatively. The use of the postal system to deliver anthrax spores is 
but one example of how little our current defensive program understands 
the broad range of possibilities for biological terrorism.
    In the time immediately preceding a biological attack, the best 
approach is a detection and warning system. Current bio-detectors are 
characterized by the scientific community as ``detect to treat'' rather 
than ``detect to warn''. This is due to the lag time between collection 
of appropriate samples and identification of potential pathogens. The 
BioWatch program, currently set up in approximately 30 cities in the 
U.S. makes use of environmental monitoring in specific locations. While 
this is a first-step approach, without more definitive intelligence, 
the cost to establish and maintain a sufficient number of biodetectors 
throughout the United States is prohibitive. Current detector systems 
use triggers that respond to increased particles in the air, followed 
by laboratory analysis of samples that are collected by one of several 
means. Current identification systems rely on specific antibodies or 
nucleic acid probes to identify' the specific agent. Obviously then, 
these systems are limited in their capability since, by design, one 
must know what you are looking for in advance. More research is 
desperately needed on generic systems that can act as a first alert. 
Some approaches toward these types of systems include receptor based 
technology and living cells that may respond to any number of toxins, 
chemicals, or biological agents. The level of sensitivity and 
specificity for biodetectors still needs improvement. While some assays 
are very sensitive, others are not yet at the level of being able to 
detect small doses which can cause human illness.
    However, perhaps even more important than improvements in detector 
technology (for they will come incrementally), is the need for a 
concept of operations. Assuming one had a ``perfect'' biodetection 
system-i.e., one that had the ultimate degree of sensitivity, an 
absolute ability to distinguish false positives and false negatives, 
and one that could operate without fail for long periods of time, the 
question still remains: Who is responsible for analyzing the 
information, what is the chain of command for disseminating the 
information, and what response can be taken? True, for some of the 
biological threats, prompt initiation of antibiotics may be effective 
in preventing onset of disease. For others, post exposure vaccination 
may be appropriate; however, sufficient pre-clinical and clinical data 
are needed before this approach can be advocated on a large scale. 
Finally, there are still many agents on the threat list for which there 
is no treatment, and therefore, a ``detect to treat'' approach is 
doomed to failure.
    Another approach at protection following an alarm, is that of 
individual and collective protection. This is the approach used by the 
DOD to protect military members in chemical-biological environments. 
While it may be impractical to provide the entire population of this 
country with protective masks, this is indeed the approach taken by 
Israel. It seems apparent that more work is needed in the areas of 
improved physical protection for the citizens of this country.
    Finally, following a potential terrorist attack with a biological 
agent, there is the problem of residual contamination and clean-up. 
This has turned out to be a major problem in sufficiently cleaning 
facilities that were contaminated with anthrax spores. New 
decontaminants are needed that are environmentally friendly, safe to 
use on humans and sensitive electronic equipment, can be dispersed over 
large areas (both open and enclosed, work quickly, and are inexpensive. 
It would be desirable to have one decontaminant that is effective for 
both chemical agents as well as biological agents (specifically anthrax 
spores).
    A robust science and technology program is needed that covers all 
aspects mentioned above-i.e. intelligence, detection, individual and 
collective protection, and decontamination. Medical countermeasures are 
the final component of a comprehensive approach and will be discussed 
in the following section of my statement.

MEDICAL COUNTERMEASURES FOR BIOLOGICAL AGENTS
    A significant effort is being undertaken to improve the status of 
medical countermeasures for biological agents. This issue first 
received a high priority within the Department of Defense during 
Operation Desert Shield/Desert Storm. The leadership of the Department, 
as well as the nation as a whole, came to realize that we went into 
that conflict with only one vaccine licensed by the Food and Drug 
Administration. The anthrax vaccine had been approved in 1970, and had 
been is limited use by at-risk laboratory workers, some veterinarians, 
and a few commercial industries (wool mills).
    Surge capacity for large quantities of this vaccine was an 
immediate need, however, the pharmaceutical industry was not able to 
respond. Further, there were no products available that had been 
specifically licensed for treatment of anthrax (which means indicating 
that on the product label and package insert). Animal studies conducted 
by the DOD were instrumental in providing data to show that 
administration of antibiotics post exposure were effective (under the 
controlled conditions of the experiments). Subsequently, several 
antibiotics have now been approved by the FDA for treatment of anthrax. 
However, post-exposure use of anthrax vaccine is not yet approved by 
the FDA and such treatment must be conducted under the rules of 
Investigational New Drugs. Beyond anthrax, there were almost no 
products available for immunization or treatment except very limited 
quantities of a toxoid for Cl.botulinum, and even more limited supplies 
of antitoxin for treatment. Realizing the lack of a commercial market 
and poor incentives for the industry, the DOD undertook a number of 
different studies to address the problem. Meetings with industry raised 
their specific concerns, namely: indemnification and liability; long-
term commitment of government funds; setting priorities for vaccine 
production (i.e. balancing current marketable products versus 
developing a stockpile of vaccine for limited use); needs for 
additional studies to validate animal models and conduct necessary pre-
clinical trials; expenses associated with larger clinical trials, even 
if only to establish safety and immunogenicity of a new product; and 
bio-safety and bio-security concerns. The concept of a Government 
Owned-Contractor Operated (GOCO) vaccine facility was supported within 
the DOD budget request in the mid-1990's, but was subsequently 
withdrawn in favor of an approach that relies upon private industry to 
meet the vaccine needs of the DOD. This Joint Vaccine Acquisition 
Program (JVAP) has been in place for over five years, and no new 
products have been licensed. The recent report by the prestigious 
Institute of Medicine entitled ``Giving Full Measure to Medical 
Countermeasues'' describes problems associated with the current 
approach and recommends alternatives for both the research and 
development aspects of a biodefense program as well as procurement 
issues. A vigorous effort must be made to shorten the time frame for 
new medical countermeasures.
    In the time since the Gulf War (now more than 10 years), we still 
have no new medical countermeasures licensed and available. (I am 
discounting the additional quantities of smallpox vaccine since that 
was not a result of new research and development). Now, the budget of 
the Department of Health and Human Services has been increased 
dramatically, providing over $1.6 B in fiscal year 2004. This dwarfs 
the investment made by the DOD, and it has initiated an obvious shift 
from DOD to HHS (NIH and NIAID) as the primary funders for biomedical 
research against terrorist use of biological agents. However, the 
history of NIH has been one of investigator initiated research rather 
than one that is threat based or driven by requirements. Further, the 
NIH has traditionally been strongest in basic research, with much less 
attention on product development; clinical trials, and licensing of new 
products. New regulations on handling select agents may deter some 
academic institutions (the traditional strength of NIH grants) from 
working in this area. It will take years for some of the basic research 
that is just getting started to pay off. It will be important to 
maintain the momentum that has been started.

THE ROAD AHEAD
    Realizing that the threat of bioterrorism or use of biological 
agents by a traditional adversary could cause irreparable damage is a 
most dramatic incentive to the various Departments of the government to 
coordinate and find accelerated ways to address the problem in the 
shortest amount of time possible. The Department of Homeland Security 
has the lead in most areas of the science and technology programs, with 
the Department of Health and Human Services having the lead in medical 
countermeasures. The role for the Department of Defense is still 
unclear in many aspects, but it is obvious that much of the knowledge 
we have today is resident within the DOD. It is essential that we do 
not waste time reinventing the wheel, or repeating work simply because 
of parochial interests.
    First priority should be given to a thorough analysis of the threat 
and a prioritization within the vast array of projects that could be 
funded. Not every project of purely scientific interest deserves 
funding. Measures of effectiveness must be established and publicized. 
Areas of common interest to the individual Departments must be 
leveraged to shorten time lines. Formal communication and 
collaborations must be established that transcend individuals involved 
in the programs. Budgets must be aligned to avoid duplication. Senior 
officials must be held accountable. Results are imperative. The future 
welfare of our country depends on it.

    Mr. Turner. Dr. Hearne.

 STATEMENT OF DR. SHELLEY A. HEARNE, EXECUTIVE DIRECTOR, TRUST 
                    FOR THE AMERICA'S HEALTH

    Dr. Hearne. I hope to be just as efficient in covering all 
these bases.
    Good afternoon and thank you for holding this hearing on a 
very important issue. I am Shelley Hearne, the executive 
director of Trust for America's Health, a nonprofit, 
nonpartisan organization dedicated to preventing epidemics and 
protecting people.
    Everyone in this room knows full well about the threats and 
concerns of bioterrorism. Certainly the Hill has experienced 
many of those attacks in person with ricin and anthrax. What is 
important to remember is that the 2001 attacks were a 
relatively minor event that absolutely overwhelmed our public 
health system. They overwhelmed our labs. They besieged our few 
epidemiologists out there and they revealed that most States 
don't have a bioterrorism plan. In my home State of New Jersey, 
postal workers and others were told to go find their personal 
doctor and to get the antibiotic Cipro if you had a doctor, 
because the local health agencies were not prepared to do 
delivery and emergency distribution of those supplies. This was 
not the American public health system's finest hour.
    The good news we had in that event is that it was a strain 
that was not drug resistant and it was also responding to a 
widely available antibiotic.
    But having stockpiles of medicines and vaccines will not 
protect us without a fully functional public health system that 
includes those disease-tracking systems that can quickly pick 
up an event and have the labs that can do the biological and 
chemical testing to figure out what that agent may be and--
critically--the public health workforce who knows how to 
rapidly respond.
    It is the teamwork between the pharmaceuticals and the 
public health system that is going to prevent a pandemic 
epidemic. Its only bottom line is--I will show my older days as 
an aging jock here--but your team is only good as your weakest 
player, and the problem is that the public health system has 
been sitting on the bench for decades now with neglect.
    After those 2001 attacks, the administration and Congress 
recognized those public health gaps and quickly responded by 
investing nearly $2 billion to jump-start the Nation's 
bioterrorism preparedness efforts. The question now is, are we 
better prepared? And the answer is, not yet.
    Our recent report that the Trust put out found that States 
are only modestly better prepared to respond to a health 
emergency. We have seen some very good progress in the area of 
communications in developing those initial plans and making 
sure even that the bioterrorist leaders were getting connected 
to homeland security frontline responders. But our report also 
showed there is enormous room for improvement. We examined 10 
key indicators in every State, looking at how well prepared 
they are. We found that almost 75 percent had scores of 5 or 
lower.
    Let me run through some of the particularly serious 
shortcomings we found. We found that only two States had 
achieved full readiness, or the green status, to receive, 
distribute, or administer emergency vaccinations and antidotes 
from the Strategic National Stockpile. Since then, another 
State has joined the ranks, but we have also heard reports that 
as many as six States have actually regressed in their current 
status. We found that only six States had sufficient laboratory 
capacities to deal with a major public health emergency.
    Ms. Hearne. We also found an enormous public health 
workforce crisis, particularly with epidemiologists, 
environmental specialists needed for chemical events and other 
trained experts
    Other initiatives such as the U.S. Postal Service are 
intriguing ones that we need to consider, but they do not 
address the dire absence of needed public health professionals. 
Bottom line is the decisions about pediatric doses, for 
instance, need to be made by a doctor and not a delivery man at 
the door.
    Nearly 66 percent of these States, which are facing budget 
crisis, have also cut funding for their public health 
activities. This finding seriously dilutes the impact of the 
Federal investments that have been made for bioterrorism.
    To be battle-ready with our public health defenses at all 
levels--Federal, State, and the local levels--it is going to 
take years of a sustained commitment, funding, and oversight.
    The Trust for America's Health is recommending the 
following actions:
    One is that HHS has informed Congress about plans to 
redirect $55 million of State and local bioterrorism 
preparedness funds to new initiatives, including the 21 high-
risk cities, and plans to activate the U.S. Postal Service for 
stockpile delivery. Under that proposal, every State will 
receive a cut of over $1 million. Shifting money from one 
preparedness initiative to another is not the solution today 
for nationwide bioterrorism readiness, especially when we are 
finding that all States have still significant areas of 
vulnerability. The House Labor-HHS Appropriations Subcommittee 
should be urged to continue the funding to State and local 
preparedness initiatives and find additional dollars to fund 
that city readiness initiative.
    In addition, it has been noted earlier that the proposed 
2005 budget does have an 11 percent cut to the State and local 
preparedness activities. The bottom line is that our biological 
defenses are far too important to shortchange at this point, 
and in fact what we recommend is that an independent review is 
conducted to look at current expenditure needs and also to 
ensure that systems of accountability are being put in place.
    Lastly, I would like to point out that very important 
initiatives have been raised recently, such as BioSense, 
BioShield, BioWatch, but one of the concerns that is being 
raised today is that there really is no bio game plan. The 
Trust is worried that many overlapping jurisdictions, lack of 
coordination amongst the various Federal agencies; that there 
is no plan between the multitude of these interagency 
initiatives; that we need to have a clear leader in charge; 
that a bio game plan is a critical element so that we 
understand the different parts and ensure that teamwork.
    Certainly terrorism thrives on uncertainty, and we don't 
know what the next attack may be, if it is smallpox, sarin gas 
or a small radiologic explosion. We must continue to invest in 
these important programs like BioShield, but you cannot accept 
that vaccinating the public is the solution unless you have 
that equal rapid response, highly trained, well-equipped Public 
Health Service to rapidly detect, manage, and contain all 
health emergencies. It is the team work that we need in the 
United States, and I hope that through this committee's work we 
can continue to urge that progress and direction. Thank you.
    Mr. Shays. [Presiding] Thank you, Doctor.
    [The statement of Ms. Hearne follows:]

                Prepared Statement of Dr. Shelley Hearne

    Good afternoon. I am Dr. Shelley Hearne, Executive Director of 
Trust for America's Health (TFAH), a non-profit, non-partisan 
organization dedicated to saving lives by protecting the health of 
every community and working to make disease prevention a national 
priority. I would like to thank Chairman Cox, Ranking Member Turner and 
the entire Select Committee on Homeland Security for holding this 
important and timely hearing. On behalf of Trust for America's Health, 
I appreciate the opportunity to testify about the role public health 
plays with respect to homeland security, particularly in the event of a 
biological, chemical or radiological terrorism event.
    Since September 11, our nation has faced a series of dramatic 
wakeup calls with respect to the state of public health preparedness 
and we have repeatedly seen that the country is ill-prepared to respond 
to a large-scale health emergency. The 2001 anthrax crisis was a 
relatively minor event, yet it overwhelmed the nation's limited public 
health laboratory capacity, besieged epidemiology investigators, and 
revealed that no emergency pharmaceutical distribution system existed. 
In my home state of New Jersey, postal workers and others who were 
potentially exposed to anthrax were told to go visit their personal 
doctor to obtain the antibiotic Cipro, since the local heath agencies 
did not have the ability to distribute emergency supplies. This was not 
the American public health system's finest hour.
    The good news was that this strain of anthrax was not drug 
resistant and was treatable with a widely available antibiotic. 
However, having stockpiles of effective medicines or vaccines will not 
protect us without a functional public health system that includes 
disease tracking systems to quickly detect an attack, labs that can 
identify the biological or chemical agent, and a trained public health 
workforce that can rapidly respond.
    As Americans we have long taken special pride that our nation has 
set the pace for disease prevention and control worldwide. But today, 
the nation's public health system is being stretched to the breaking 
point.
    Congressional approval of $5.6 billion for Project Bioshield 
represents one step forward toward better bioterrorism preparedness in 
America.
    Smallpox is a good example of how important it is to have both 
effective countermeasures and a competent public health system. The 
Department of Health and Human Services (DHHS) invested wisely in 
expanding and enhancing the nation's smallpox vaccine supply. In the 
event of an outbreak, the strategy is to ``ring inoculate.'' Executing 
this strategy requires astute clinicians to notify public health 
officials or disease surveillance systems capable of detecting a 
possible smallpox event, labs that are able to rapidly test and confirm 
smallpox cases, and deployment of rapid response teams who can deduce 
who has been exposed and inoculate anyone possibly exposed. If managed 
correctly, a smallpox event could be caught early and contained. The 
team work of pharmaceuticals and public health could prevent a global 
pandemic. But a team is only as good as its weakest player.

The Nation's Current State of Public Health Preparedness
    Unfortunately, due to decades of neglect, America's public health 
system has been sitting on the bench. Following the terrorist attacks 
of 2001, the Administration and Congress recognized that significant 
gaps in public health made the nation vulnerable to attack and 
responded quickly and appropriately by investing nearly $2 billion to 
help jump start our nation's bioterrorism preparedness efforts. The 
infusion of funds into the public health system was sorely needed and 
most welcome. Yet, two years of bioterror funding cannot make up for 
decades of underinvestment in the nation's public health system.While 
progress has been made in state and local preparedness for public 
health emergencies, much more remains to be done.
    Six months ago, TFAH released a state-by-state report, assessing 
whether or not the nation was better prepared for another terrorist 
attack or other major health emergency given the $2 billion federal 
bioterror investment over the last two years.
    The short answer is: ``not yet.''
    Our report, Ready or Not? Protecting the Public's Health in the Age 
of Bioterrorism, found that states are only moderately better prepared 
to respond to health emergencies than they were prior to September 11. 
We found that some good progress has been made in most states to 
improve communications with the public and between health agencies. 
Every state had at least an initial plan on paper of how to mobilize 
public health resources in the event of a terrorist attack.
    However, the report also found that there is much room for 
improvement. The report examines 10 key indicators to assess areas of 
improvement and areas of ongoing vulnerability in our nation's effort 
to prepare against bioterrorism and other large-scale health crises. We 
found that nearly 75 percent of states earned positive marks for only 
half (five) or fewer of the 10 possible indicators.

        Some of the most serious shortcomings include:
         In December 2003, only two states had achieved full 
        readiness or ``green'' status with respect to receiving, 
        distributing, and administering emergency vaccinations and 
        antidotes from the Strategic National Stockpile. Since then, 
        another state has joined their ranks. At the same time however, 
        six states have reportedly regressed with respect to their 
        stockpile status. Moreover, there is confusion and uncertainty 
        about the roles and responsibilities of federal agencies, 
        including the Departments of Homeland Security (DHS) and 
        Veterans Affairs (DVA) and the Centers for Disease Control and 
        Prevention (CDC).
         Only six states report that they have sufficient 
        laboratory facilities should a major public health emergency 
        occur, such as a mass mailing of anthrax, simultaneous release 
        of sarin gas in U.S. subways, or even a potential outbreak of 
        plague. These findings build on those of an earlier TFAH 
        report, Public Health Laboratories: Unprepared and Overwhelmed. 
        This study found that even fewer state public health 
        laboratories had the ability to detect chemical weapons in its 
        citizenry. The Association of Public Health Laboratories 
        (APHL), found that only eight state public health laboratories 
        have a chemical terrorism emergency response plan in place. 
        This observation is even more alarming in light of the ricin 
        incident on Capitol Hill earlier this year.
         There is a serious public health workforce crisis, 
        including a shortage of epidemiologists and other trained 
        experts. Rather than recruiting and training a new public 
        health workforce, which requires a serious investment of time 
        and money, many states had planned on mobilizing National Guard 
        personnel in the event of a health emergency to deliver 
        medicine and equipment from the Strategic National Stockpile. 
        Yet, as we have recently seen, these troops may be deployed 
        elsewhere, leaving millions of Americans vulnerable during a 
        public health emergency. Alternative initiatives, such as using 
        the U.S. Postal Service, are intriguing, but fail to address 
        the dire need for more public health professionals. Decisions 
        about pediatric doses, for instance, need to be made by a 
        doctor, not the delivery man at the door.
         Nearly 66 percent of states, facing budget crises, 
        have cut funding for public health activities. This seriously 
        dilutes the impact of the federal government's investment in 
        bioterror preparedness.
    Since TFAH released its report in December, similar national 
investigations have confirmed our findings. In February 2004, the 
General Accounting Office (GAO) issued a report detailing the 
preparedness gaps nationally, including the discovery that no state had 
completed all CDC program requirements. Just days ago, the RAND 
Institute found that in California--a state that TFAH had ranked as one 
of the best prepared in the nation--there was enormous variability in 
city and local public health readiness.

What Can the U.S. Do Now to Better Prepare for a Bioterror or Chemical 
Terrorism Event?
    The American public health community has a solid understanding of 
the many actions that should be taken to make our country more safe and 
secure. However, achieving a battle-ready public health defense at the 
federal, state and local levels will take years of sustained 
commitment, funding and oversight.
    To stop the hemorrhaging of the nation's public health 
infrastructure and to achieve the optimum all-hazards approach to 
public health preparedness, TFAH recommends that Congress take the 
following actions:
         Despite a number of reports suggesting that states are 
        only modestly better prepared to handle a terrorist attack, CDC 
        funding for state and local preparedness capacity is in danger. 
        The Secretary of Health and Human Services has informed the 
        House Labor Health and Human Service (LHHS) Appropriations 
        Subcommittee that he intends to redirect $55 million dollars, 
        that had been allocated previously to state and local 
        bioterrorism preparedness efforts, to support instead targeted 
        improvements in 21 specific cities and the U.S Postal Service 
        Strategic National Stockpile initiative. Under the proposal, 
        almost every state will sustain a cut of over $1 million. Sec. 
    To protect all Americans, TFAH believes that there is a need to 
increase funding to enhance the readiness of targeted cities, while 
maintaining key CDC bioterrorism preparedness programs. However, we do 
not believe that the Cities Preparedness Initiative should jeopardize 
the health and security of the rest of the nation, especially since 
report after report indicates the country is still underprepared. The 
House Appropriations Subcommittee on Homeland Security denied a similar 
request to reprogram fiscal year 2004 funds away from the Department's 
Metropolitan Medical Response System (MMRS), and we hope that the House 
LHHS Appropriations Subcommittee will follow suit and continue to fund 
the state and local preparedness grants at their appropriated levels 
and find additional dollars to fund the CDC's Cities Readiness 
Initiative.
         In addition, the CDC's fiscal year 2005 budget for 
        state and local bioterrorism preparedness programs is slated to 
        receive an 11 percent cut or a $105 million reduction. Even in 
        this tight fiscal year, Congress must restore the fiscal year 
        2005 funding; otherwise further readiness efforts at the state 
        and local levels will be derailed. TFAH recommends that 
        Congress make a long-term investment in biosecurity and 
        authorize an independent review to determine whether current 
        expenditures are sufficient. Experts note that at a minimum, 
        the nation requires a $1 billion annual commitment for the next 
        several years in order to achieve the appropriate level of 
        biosecurity.
    To assure that this investment is well-spent, CDC, in consultation 
with state and local health officials and outside experts, including 
those from other federal agencies like the Departments of Defense and 
Homeland Security, must define measurable standards for comprehensive 
preparedness that all state and major local health departments should 
meet.
         The Administration and Congress have addressed 
        bioterrorism threats by developing and funding innovative 
        programs such as Bio-Sense, BioShield and BioWatch. TFAH 
        remains concerned that there is no overarching federal 
        ``BioGame Plan.'' We worry that there are overlapping 
        jurisdictions, lack of coordination among various federal 
        agencies, and no plan for intra--and inter-agency training or 
        rapid deployment of resources in the event of an attack. 
        Congress should identify a lead agency to develop and oversee a 
        comprehensive BioGame Plan that clearly delineates the roles 
        and responsibilities of each federal agency and its state and 
        local counterparts.
         The President, in consultation with Congress, should 
        convene a White House summit that will develop a concrete 
        vision for the future of the American public health system and 
        the resources needed to make it a reality. This summit should 
        consider how our country can build a robust, integrated public 
        health infrastructure. TFAH believes that such a summit could 
        craft a blueprint for a public health system that is designed 
        to meet both America's current and emerging health threats. The 
        discussion must include how to develop a public health system 
        for the 21st century--the summit should address all aspects 
        essential to public health, such as bioterrorism, chemical, and 
        radiological preparedness, known and emerging infectious 
        diseases and chronic disease prevention and control. At the 
        same time, we believe the summit should foster a long-overdue 
        dialogue about the resources required to implement needed 
        changes and guarantee accountability at every level of the 
        public health system.
    Terrorism thrives on uncertainty. We don't know when or where the 
next attack might be launched or whether it will be smallpox, Sarin gas 
or a small nuclear device. While we must continue to invest in 
defensive programs like BioShield, we cannot expect to vaccinate 
Americans against all threats unless we have a nimble, highly-trained, 
well-equipped public health defense that can rapidly detect, contain 
and respond to all health emergencies. That is the team work the United 
States needs. That is the team work Americans deserve.
    Once again, thank you for allowing Trust for America's Health the 
opportunity to contribute to the policy debate on homeland security and 
public health. I am happy to answer any questions.

    Mr. Shays. We will start out with the Ranking Member of the 
committee, Mr. Turner.
    Mr. Turner. Thank you, Mr. Chairman.
    Dr. Hearne, you certainly articulate one of the greatest 
problems that we have in terms of dealing with bioterrorism, 
and that is that we don't have the public health infrastructure 
to really respond. One of the administration's programs that 
was announced in late 2002 was this national effort to 
vaccinate 500,000 health care workers for smallpox, and that 
was supposed to be followed by the vaccination of 10 million 
first responders.
    We know we are 18 months away from the announcement of that 
program, and neither of those goals have been anywhere near 
achieved. I think there is about 40,000 or so people that have 
been vaccinated under the program, and there may be various 
reasons for it. But bottom line is, do you think we are 
prepared to deal with an attack of smallpox in this country? I 
know we heard Secretary Thompson say he thought we were 
prepared. And are we prepared to deal with an anthrax attack in 
this country? And can we distribute a stockpile that they tell 
us is out there in the event there is such an attack?
    Dr. Hearne. These are challenging issues, and certainly 
frightening ones to discuss and talk about. We are better 
prepared, and in the event of a smallpox, anthrax, or even an 
unexpected event--because that is the reality of terrorism, you 
don't know what is going to be thrown over the transom--we have 
seen some important improvements.
    I do think in the specific instance that you asked with 
smallpox, we probably are a bit more vigilant. We would catch 
it early, which is really the most critical part of smallpox. 
We are not in a position or a policy to be able to vaccinate 
the entire country. We must pick it up quickly and do that ring 
inoculation, try to squeeze and contain smallpox.
    Could we do as good a job as we should? I don't think so. I 
suspect we would have far more cases than if we were fully 
prepared as we should be, and that is where we need to see 
these stronger investments. We don't know where a smallpox 
would hit. And while you might want to target certain cities 
and heighten that capability, the reality is we need to have 
that vigilance across the board and improve our ability to 
rapidly respond at all levels in this country, and that has not 
been a priority and a response that we have seen yet today at 
the level that we would like.
    Mr. Turner. So is the answer yes or no? Could we respond 
adequately? Are we anywhere close to being adequately prepared 
to deal with even anthrax?
    Ms. Hearne. We are better prepared for anthrax. You want a 
yes or no? Not yet. We would do our best, and it would be 
certainly better than it was pre-9/11, but it is not as good as 
it should be.
    Mr. Turner. Do you have any indications that the 
administration is going to request the kind of funding that you 
believe would be necessary to get us prepared to deal with 
either anthrax or smallpox?
    Dr. Hearne. Let me make a very important point. Public 
health probably is the weakest link in homeland security today, 
and public health has also been the Cinderella issue of this 
country for over 20 years. This has been benign neglect, 
really, by many administrations. And recently this has been the 
most critical investment that we have had in public health in, 
as I have noted, decades.
    Is it enough? No. And part of the issue is that it needs 
both a sustained and long-term commitment, but it 
simultaneously needs to have a much better set of performance 
measures and accountability so that people can be in a better 
position to answer those questions that you are asking, Mr. 
Turner, are we better prepared, where are our gaps, and what do 
we need to do? And that comes with not just money, but it also 
comes with the accountability metrics that are long overdue.
    Mr. Turner. Dr. Winegar, is project BioShield an adequate 
response to the bioterrorist threat?
    Dr. Hearne. It is one piece of the triad here. You know, as 
my testimony was pointing out, the ability to have drugs as a 
countermeasure are invaluable, but without the ability to 
deliver or have the brains at the head of the system that can 
both pick up an event and can rapidly determine who needs what, 
how to cover our population, it really doesn't matter what 
drugs you have, because those will be wasted countermeasures 
without the ability to do right and adequately protect the 
public's health.
    Mr. Turner. Dr. Winegar.
    Ms. Johnson-Winegar. I agree that certainly BioShield is 
one component of an overall strategy, but as a stand-alone 
effort, it is not enough. And I wanted to reiterate the comment 
that I made before. I still think that there is a gap between 
the work that is going on as basic research and the procurement 
of items, and, as I have understood the legislation, that 
indeed is procurement of items that are not licensed but that 
have the potential to be licensed. And I think that that is 
where there is a large gap that really needs to be addressed. 
And that is the appropriate types of animal models and the 
appropriate clinical trials that, if necessary, address 
pediatric populations, elderly populations, populations with 
individuals who have an immuno-compromised system or other 
health problems that may prevent them from taking a vaccine 
that may be perfectly acceptable for normal healthy people in a 
limited age range.
    So I think it is a step in the right direction, but as a 
stand-alone, it is certainly not the end-all, be-all.
    Mr. Turner. Thank you. Thank you, Mr. Chairman.
    Mr. Goodlatte. [Presiding] I thank the gentleman.
    It is my pleasure to recognize the gentleman from 
Connecticut Mr.Sec. ays.
    Mr. Shays. Thank you very much. I want to thank both of you 
for being here. Dr. Hearne, it is, I think, a very important 
statement that you made that you said public health is the 
weakest link in our war against terror, and I just hope that 
that doesn't get lost on people.
    I want to know, Dr. Winegar, if you agree as well. You no 
longer work for Defense now. You can be totally candid.
    Ms. Johnson-Winegar. I have always tried to be candid with 
you, sir.
    Mr. Shays. But you have no restraints, there are no 
restraints?
    Ms. Johnson-Winegar. I think public health is one of the 
major elements of a comprehensive defense. To say that it is 
the weakest link is perhaps a bit further than I would like to 
go. And I would like to say that the whole area of biodefense 
has been the ugly stepchild for many years. I personally fought 
many, many battles within the Department of Defense to try to 
get us a sufficient amount of funding, and while we all know 
that funding isn't the total answerSec. 
    Mr. Shays. But given what you said, it is the ugly 
stepchild, so is there anything more ugly? I mean, is there 
another issue--the weakest link means it is the weakest link. 
It may be relatively good or not, but it is the weakest link. 
What do you think is the weakest link if it is not this?
    Ms. Johnson-Winegar. I think intelligence is the weakest 
link.
    Mr. Shays. Okay, fair enough. Well, we have identified two 
pretty weak links. Okay. And thank you for that answer.
    I want to ask both of you how you have the capability to 
match the threat. And before you respond to that, I want to 
know if you believe bioterrorism is a legitimate concern that 
our country needs to defend against. We will just keep going 
back and forth. I will start with you, Dr. Hearne.
    Dr. Hearne. Absolutely, it is a significant concern. We 
have already had a number of reminders of that. While they have 
not been major events, I don't think anyone on thisSec. 
    Mr. Shays. So the bottom line is yes?
    Dr. Hearne. Yes.
    Mr. Shays. And, Dr. Winegar?
    Ms. Johnson-Winegar. Yes, I agree.
    Mr. Shays. Do you believe that we are matching--I think I 
know the answer to this--is the capability matching the threat? 
And I think both of you have said no, but let me ask this 
question: Does that say to you that this needs to be more than 
a 9:00 to 5:00 effort or an 8:00 to 6:00 effort, that it may 
need to be, you know, 24 hours a day until we get to at least a 
certain level?
    And I will start with you, Dr. Hearne.
    Dr. Hearne. You are probably starting with me because I am 
nodding my head vigorously. Absolutely it should be 24-7. We 
had that lesson with public health agencies. People would call 
on a Friday evening to report a possible case. There was no one 
answering the phone. That has been a major change since 9/11. 
We have gotten our agencies up to 24-7, response capability, 
but simultaneously we are actually hearing stories now that 
with budget cuts both at the State and Federal level and also 
at some of the local entities, those actual 24-7 response 
capabilities are being threatened.
    Mr. Shays. But how about the capability for making sure 
that we have the antidotes to certain biological agents?
    Dr. Hearne. The Strategic National Stockpile has enormously 
expanded and improved our ability to have readiness on that 
scale. The issue is with the stockpile being ready, are the 
States ready to receive those materials and do the distribution 
that would be needed in a major event.
    Mr. Shays. Well, we had testimony that said we are 2 to 3 
years away, and under a really significant event, we may be 4-
plus years away. So should we just decide that should be the 
time schedule, or should we speed it up?
    Dr. Hearne. We absolutely could speed this up, and it is 
really an issue of going back to my premise that this has been 
the weakest link, that it has been the Cinderella agency in 
most States. It has not been a priority. And given if this were 
put up higher on the radar screen and given the top level of 
commitment by key policymakers, you could turn around these 
gaps in a very rapid time period.
    Mr. Shays. Thank you.
    Dr. Winegar.
    Ms. Johnson-Winegar. I absolutely agree, and while some of 
the comments that were made earlier on how fast a particular 
research project can proceed are constraints on time, I too am 
quite dismayed by the long periods of time, and I would like to 
go on the record as saying that my estimate of when we will 
have sufficient antidotes for clostridium botulinum is in the 
10-plus years away.
    Mr. Shays. Nine was what I had heard, and I was surprised 
that we were being told less. One of the dangers in the 
Department is they want people not to be afraid, but my view is 
since September 11th, we need to make sure that people are told 
the truth, and particularly Members of Congress so we are not--
I am just interested--was I given 5 or 8 minutes? Ten minutes. 
Would you mind if I had 1 more minute? Do you need to get a 
plane?
    Mrs. Christensen. Go ahead.
    Mr. Goodlatte. Without objection, the gentleman is 
recognized.
    Mr. Shays. I wanted to just ask that last question, which I 
forgot. And it was my wrap-up question. So thank you. Just 
totally forgot it. Thank you for your kindness, Doctor.
    Mr. Goodlatte. I thank the gentleman.
    It is now my pleasure to recognize the gentlewoman from the 
Virgin Islands.
    Mrs. Christensen. Thank you. I will see if I can get 
through this quickly, and then maybe Chris will remember his 
question.
    But thank you for being here and for bringing the message 
that you bring, because we need some echoing of that message 
every time we talk about health and biodefense.
    You know, I am concerned about the shifting of the funds 
from our everyday needs in public health to homeland security, 
which is obviously a priority and we need to ensure that we 
have the proper defense preparation, the ability to respond to 
bioterrorism. But the funding for public health preparedness in 
bioterrorism usually means--it has begun to mean taking away 
from some of the other functions. And given these concerns and 
our experience up to date, isn't it possible to not shift but 
make bioterrorism funding really dual use? What would either of 
you say about that and the approach that we should be taking?
    Dr. Hearne. Ideally, if we are smart on these investments, 
we do create a system that is all-hazards approach, whether it 
is a terrorist event or Mother Nature throwing the unexpected 
at us, like SARS, like avian flu. You don't know what is going 
to hit, but they can all be of equal consequence.
    You need to make sure that those investments are there, 
and, unfortunately, we have been shifting dollars, so that 
while we cover one flank, we are leaving our other exposed and 
quite vulnerable to unexpected events.
    We are hearing stories all across the country of things 
like restaurant inspections. It may sound real sexy, but one 
that could be a form of food agricultural terrorism. But, two, 
it is a major event that goes on in this country that is 
preventable; and that is the bottom line if public health does 
its job. It is keeping people from getting sick in the first 
place, whether it is bioterrorism or those other everyday 
health risks.
    One of the things that we ask is we shouldn't be robbing 
Peter to pay Paul here, and the cities initiative isn't a very 
important one. I don't mean to take anything away from it. It 
is just that we shouldn't be taking money from one place to the 
other when they are both underfunded as currently seen.
    What in fact I think we really need to do here is stop for 
a moment and really take a look at we have not modernized our 
public health system really since the day it did its job back 
in the 1800s in stopping cholera and typhoid and yellow fever. 
Those were extraordinary investments that made a difference.
    We are in a very different place today. We have got very 
different sets of threats. Anthrax or asthma, chemical weapons 
or cancer. We actually could have a much smarter public health 
system that could do its job in preventing all of those 
diseases much more effectively with probably not huge amounts 
of dollars, but we haven't set it up that way.
    And in fact, one of the recommendations that we have in 
this report here is calling on Congress and the administration 
to host a national summit on modernizing, creating that 21st 
century public health defense, because there isn't a lot of 
money out there. But we could be doing a lot more, a lot 
better, smarter, safer, swifter, and we just need to take that 
time out and figure out how to put those pieces together, 
because there is a win here. We are just keeping it off the 
radar screen.
    Mrs. Christensen. Did you want to add anything?
    Ms. Johnson-Winegar. I certainly agree with those points, 
and I would like to call your attention to the fact that many 
of the things that are on the threat list or thought of as 
bioterror agents also occur in other ways, and I will go back 
to Congressman Shays' example of botulinum toxin. Botulinum 
toxin is found in food poisoning, and we need to leverage what 
we have learned about treating those types of cases and 
diagnosing them and apply that to the use of the toxins as a 
biothreat. Now, of course there are going to be differences, 
but I think there needs to be a much greater collaboration and 
leveraging of the work that is done in the endemic disease, the 
emerging infectious diseases, with those things that are in the 
bioterrorist realm.
    Mrs. Christensen. Thank you. You know, when we visited 
several sites around the country and talked to first 
responders, several who had done exercises in responding to a 
simulated terrorist threat, we didn't find that public health 
and hospitals were really fully a part of the first responder 
team, and I was wondering what are you seeing.
    Dr. Hearne. That may be one of the areas of most 
improvement out there. We hear across the board that for the 
first time ever, public health leaders know who their 
counterparts are in Homeland Security, in law enforcement, even 
EMS, which is a little surprising, you would have thought.
    Clearly, though, there is also room for improvement. We 
have been hearing surprising reports. The RAND Institute, for 
instance, just put out a report a few days ago that looked 
intensively in California and actually found that public health 
departments knew their minority populations less than the 
police departments.
    Now, what was interesting--we can take that a little 
further, but one of the things that was coming out of that is 
that public health has actually not been as engaged with 
disadvantaged populations as it could be and should be and 
particularly in the event of a bioterrorism outbreak, that the 
lack of those connections to key populations may be a 
significant problem.
    So while there have been some very interesting new 
connections being made, some of the basic arenas that public 
health has been presumed to be doing well actually need to be 
improved.
    Mrs. Christensen. Thank you. And I thank you for alluding 
to the issue of minority populations, which I am sure you know 
is one of great concern to me.
    Thank you, Mr. Chairman.
    Mr. Goodlatte. I thank the gentlewoman, and it is my 
pleasure now to recognize the gentlewoman from Texas, Ms. 
Jackson-Lee.
    Ms. Jackson-Lee. I thank the distinguished Chairman, and I 
thank the committee for this hearing. I laid out a scenario in 
the previous panel, just to suggest that all of us can do well 
by taking what we are doing more seriously, and I appreciate 
the work of both of you on this issue and the years of 
commitment.
    My relaying of the anecdotal story regarding the 
pronouncement of the Attorney General was just to suggest that 
I think that 99.9 percent of Americans went about their daily 
business; and it is twofold, probably a tribute to how far we 
have come and what Americans believe we have done on their 
behalf. And maybe the other point is the lack of completeness 
in understanding of how much more we need to do.
    So I think these hearings are important, because if 
Congress has any role it is oversight, and sometimes our 
oversight is not pretty. It has to be probative. It has to be 
provocative. And I say that because I want to compliment the 
Texans who were engaged in the work of dealing with the 
tularemia, and I don't want to take anything away from them, 
because Texas certainly has the advantage of having the likes 
of the Texas Medical Center. But also there are rural aspects 
of Texas that are not connected to such a fine network that is 
found maybe in Harris County, Houston, Austin, where the head 
of the Department of Health is, and of course connected to the 
Texas Medical Center.
    So here is my point of questions, and I want to use, Dr. 
Hearne, your statement, and I would welcome the input of both 
of you. But my question goes back to the example of smallpox 
and the fact that we need to have--if we use that as an 
example, if I understand, you are suggesting that we need 
public health officials. We need to have astute clinicians to 
notify public health officials, or disease surveillance systems 
capable of detecting possible smallpox. We need labs that can 
rapidly test to confirm smallpox cases. We need deployment of 
rapid response teams who can deduce, and we need a working 
pharmaceutical network as well.
    There are many elements that I am concerned that, although 
good intentioned and we have made progress, I want to be 
provocative, I want to be piercing, because we will have no 
time to be that in time of crisis, and I do believe that we are 
still geared to looking for the airplane coming into our 
neighborhood. And we hear the word bioterrorism, we hear the 
word radiological attack or a chemical attack. I am not sure if 
we fully comprehend. And if we comprehend it in Texas, if I 
might use this as a laboratory, it is only because we live with 
refineries, and we live in what has been labeled the oil 
capital of the world. We have lived with natural gas and oil 
for many years. We have lived with our refineries and their 
fires, but no one can comprehend what it means to release a 
dirty bomb. No one can comprehend a purposeful attack on those 
refineries, short of an accident which is what you are used to.
    So what I am trying to determine, we have made advancement 
in legislation that was passed soon after 9/11. We are now 
dealing with BioShield. I am not comfortable in even what we 
have gotten out of this hearing, with all due respect and 
appreciation of our fine public officials in Washington. I am 
not comfortable that we have a circumstance, if you will, 
that--or a set of circumstances that really have given us 
standards, has a network that is connected. Maybe I am 
connected in the fourth largest in the Nation. I am lucky, but 
I might be not be connected in a poor neighborhood in the 
fortieth largest city in the Nation, and I may not be connected 
50 miles down the road, which turns rural as soon as you leave 
outside of the borders of Houston, you are in rural Texas.
    So if you can give me the bad news and the roadmap to get 
from the bad news to where we are--and I know that some members 
already asked that--that would be helpful to us, because I just 
think that we are treading light waters and being polite. And 
let me just say, not criticizing any of the witnesses, because 
you have been forthright, but give us a roadmap of where we 
need to be going and who we need to be touching on these 
issues.
    Dr. Hearne. It is hard sometimes to tell the truth. Mr. 
Turner was trying to get me to say, yes or no, are we prepared? 
I don't particularly like sitting in this hot seat, having 
to--.
    Ms. Jackson-Lee. We will give you immunity. How about that?
    Ms. Hearne. If only it would cover smallpox and--here's the 
reality. We have a long ways to go. Your home State, Texas, if 
I remember right, scored 4 out of our 10 indicators. You can go 
back and take a look at where those gaps are, and there is a 
lot of work to be done in Texas, things like there is not 
sufficient laboratory capacity, there aren't enough workers. In 
fact, the budgets have been severely cut of the Texas Public 
Health Department. They tried to shut down their cancer 
registry and their birth defects registry. Birth defect is the 
number one cause of infant mortality in that State. That is 
just an example of the challenges that have been going on in 
that health department, let alone having to think about 
bioterrorism. It is not pretty what has been going on on a lot 
of these fronts, and it is an issue of priorities and care.
    But your question, in part, was you play the role of 
oversight and your job is to ask those tough questions and to 
make sure things are being covered that people may not always 
want to talk about.
    Well, one of the issues, to push back to the table of the 
panel before, of Federal authorities was where are those 
measures accountability. Dr. Raub mentioned, as an example, 
they had a metric of 1 epidemiologist per 500,000 people. Well, 
they have never actually collected that information. HHS and 
CDC does not know if there are now 1 epidemiologist per 
500,000, and in fact the benchmarks that HHS were producing 
aren't the ones that CDC are going to put out, but CDC still 
hasn't put it out and we are 3 years out in this bioterrorism 
program.
    Accountability has not been the strongest suit of these 
types of issues, and it actually has been one of the benefits 
of Homeland Security's partnership with HHS, is that it has 
brought a greater sense of urgency and push for accountability. 
But I actually think that this would be just the type of issue 
to turn back to Congress and say where are those measures, how 
are we matching up? And the reality is our group put out this 
report on its 10 indicators, because we were filling a gap to 
answer just the questions we were getting in every office on 
the Hill of, well, so how better off are we, and is our job 
done? Because many people do believe with this important 
investment that has gone on the last few years, that we are 
taken care of. But the reality is we have a very long ways to 
go. But we have not set up what are those targets, what are 
those benchmarks, and what does every citizen in this country 
have the right to anticipate in terms of the protections and 
preparedness that they should have.
    So I in some ways would appreciate to turn that back to 
Congress and to have that oversight role. It would be extremely 
helpful, because I think there are some significant cultural 
quality changes that need to take place in how we do health 
protection, and I am talking about the public health side in 
this country which has not had oversight, and it hasn't had 
really anyone caring about it before. And that is long overdue.
    Ms. Jackson-Lee. So your solution, or at least your 
suggestion, is that we intensify our oversight hearings and 
begin to probe into the State's structure or begin to probe HHS 
as to the accountability standards? Because I guess I am still 
looking for the list of accountability standards. Can someone 
point to me, can I go to the Web page, can I go somewhere and 
see their accountability standards, besides the very fine work 
that you have done? Does the government have an assessment on 
Iowa or Georgia or Mississippi or Texas or New York in terms of 
where they are? And then say categorically, you know what, they 
are at zero; they are not even talking to each other; we have 
got emergency relief for that State that is at zero, because 
that is where homeland security is?
    Dr. Hearne. No.
    Ms. Jackson-Lee. That is--.
    Dr. Hearne. Soon to come. But we have been hearing that for 
over a year now. There are benchmarks of expectations, but 
there are not performance standards set yet. CDC is in the 
process right now of--after several iterations, is trying to 
develop those performance standards. It is currently piloting 
those performance standards in, I believe, five States and 
hopes to roll them out soon; but, again, we are at a point 
where the States are waiting on their 2004 guidance and still 
hasn't gotten it. And we are here in June of 2004.
    Again, let me just--just to give a sense, public health is 
not rocket science. There are some very basic things that we 
have been doing since the 1800s but we are just not doing very 
well anymore. To set those benchmarks is critical but we need 
to have the impetus and energy and push to make sure that we 
are achieving those and that that accountability and commitment 
to hitting those marks are there.
    Ms. Jackson-Lee. Thank you. So oversight is crucial. Thank 
you.
    Chairman Cox. [Presiding] The gentlelady's time is expired. 
Dr. Hearne, Dr. Johnson-Winegar, I just have one question for 
each of you. Dr. Hearne, earlier we went into BioWatch; the 
BioWatch program, to oversimplify, starts with EPA collection, 
moves on to CDC analysis, and then, if necessary, to FBI 
investigation. There are other moving parts, but that is the 
superstructure.
    And I want to ask whether, Dr. Hearne, you think that this 
is an appropriate role, particularly assuming that it grows in 
terms of scope and complexity for EPA.
    Dr. Hearne. I should probably confess my training is 
actually as an environmental toxicologist.
    Chairman Cox. Your focus on these areas is the reason I ask 
you this question.
    Dr. Hearne. One of the problems that we have right now in 
this arena is that there are many different agencies, many 
different programs evolving, developing, and unfortunately 
there is an enormous lack of coordination and clear 
authorities.
    This is one of those areas that both has the challenge of 
where it fits, but I also would raise the issue of the concerns 
of the investments in BioWatch, in part that many people from 
the laboratory community have grave concerns about, is the best 
investment given the high rate of false positives and that the 
technology is not particularly accurate and ready to be rolling 
it out, because the number of false positives activate a very 
expensive and very costly response mechanism. And so one of the 
challenges has been that each time a sensor picks up a 
potential hit, its disconnect with the public health community 
starts and activates a very large response that overwhelms the 
system.
    It is not working particularly well right now, and it is an 
issue that needs to be given more thought and more counsel, in 
part because we hear from so many points in the public health 
system about their concerns on BioWatch.
    At the same time, this is the challenge; we need to have 
these new technologies but as currently configured, BioWatch 
does not appear to be a highly effective program.
    Chairman Cox. Given that the program itself has its own 
challenges--and take that as a given--is the structure of it, 
with EPA as collector, an appropriate structure from EPA's 
standpoint?
    Dr. Hearne. Well, I am sure EPA would say yes. Given--those 
were all systems that were originally designed and are still 
being used for air monitoring systems across the country for a 
set of air pollutants that EPA is actually by law required to 
be collecting.
    So those are units that are already in place throughout the 
major metropolitan areas collecting information. It is an idea 
that is smart in terms of it is building on an existing 
infrastructure rather than trying to reinvent the wheel. So, as 
such, it makes sense that it has been built on EPA.
    The problem is it has been done in a vacuum from the public 
health and responders who need that information.
    I guess it comes back to really the issue I brought up 
before of we probably need to take that time out and take a 
look at how all these different pieces most effectively can 
work together and how we can have a smart and strategic public 
health response rather than piecemeal parts spread out across 
the jurisdictions.
    Chairman Cox. Thank you, Dr.Sec. arne.
    Dr. Winegar, I want to ask you with respect to bioterrorism 
research in general what you think is the appropriate role down 
the road for DOD, and how do we ensure that the expertise that 
is resident within DOD is integrated with all else that is 
going on, that it is not lost in this process? And what do you 
see as the primary role for the Department of Homeland 
Security, given that they won't be doing basic human health 
research?
    Ms. Johnson-Winegar. Well, as was mentioned earlier, I 
think there is a role for everybody to play. DOD has 
traditionally been the leader in the area of biodefense and 
bioresearch. And while the individual scientists working at the 
bench probably can do equally good work for the Department of 
Homeland Security or the Department of Health and Human 
Services as he or she can for the Department of Defense, it 
would certainly help everyone, I think, to have a consolidated 
approach and clear leadership in the area. And I fear that what 
we have right now is fractured leadership, with the Department 
of Homeland Security having the lead in some areas while 
deferring the lead to HHS in the areas of medical 
countermeasures and then HHS needing to collaborate and 
communicate with DOD.
    It is very confusing to the researcher in the field, 
whether they are in academia or private industry: Do I go to 
talk to Homeland Security, do I go to talk to NIH, do I go to 
talk to the DOD? And basically what is happening is that people 
are making the rounds and going to all of those agencies and 
waiting for somebody to step up and say, yes, this is what we 
are going to do; or, no, this is not what we are going to do. 
It is confusing to the public and to the research community at 
large, I feel.
    Chairman Cox. And if you were free yourself to heal the 
fracture, who would be in charge?
    Ms. Johnson-Winegar. I think it has to be at some level 
above all the departments, and so that in my mind clearly 
points to the Homeland Security Council or the White House or 
some other body that sits above the individual departments.
    Chairman Cox. And is that true for operational decision 
making as well?
    Ms. Johnson-Winegar. I think that is important, yes, 
because there are individual components that each of those 
departments will be asked to execute, and they can't do that in 
a vacuum. And while I will agree that they are making progress, 
they still need some leadership in that whole area, I think.
    Chairman Cox. So if I understand your testimony, you would 
recommend that the Homeland Security Council be given line 
management authority over all of these Cabinet departments?
    Ms. Johnson-Winegar. At least for the interim, until things 
are more established. And I think, in addition, the Homeland 
Security Council needs to be augmented. It is my understanding 
that in the whole area of bio, you can count the number of 
people on one hand.
    Chairman Cox. All right. I appreciate very much your 
straightforward answers to my questions and appreciate very 
much your expert testimony to our panel, and with that, I would 
excuse this panel and adjourn our hearing. Thank you very much.
    [Whereupon, at 4:15 p.m., the committee was adjourned.]


                            A P P E N D I X

                              ----------                              


                   Material Submitted for the Record

Questions for the Record from Ranking Member Jim Turner for Dr. Penrose 
                        C. Albright's Responses

    National Biosecurity Analysis and Countermeasures Center

    1. What is the mission of the National Biosecurity Analysis and 
Countermeasures Center?
    Response: The National Biodefense Analysis and Countermeasures 
Center (NBACC) is the name of a facility proposed to be located at the 
National Interagency Biodefense Campus at Ft. Detrick, MD.
    NBACC will provide the nation with the scientific basis for 
awareness of biological threats and attribution of their use against 
the American public.
    NBACC will be comprised of two centers to execute this mission:
     The National Bioforensic Analysis Center (NBFAC) will 
provide national capability to conduct forensic analysis of evidence 
from bio-crimes and terrorism to attain a ``biological fingerprint'' to 
identify perpetrators and determine the origin and method of attack.
     The Biological Threat Characterization Center (BTTC) will 
conduct systematic and rigorous research to understand current and 
future biological threats, assess vulnerabilities, and determine 
potential impacts to guide the development of countermeasures, such as 
detectors, therapeutics, vaccines, and decontamination capabilitities.
    NBACC is part of the Department of Homeland Security's (DHS's) 
integrated national biodefense complex consisting of Plum Island Animal 
Disease Center (PIADC); two University Centers of Excellence, the 
University of Minnesota's National Center for Food Protection and 
Defense and Texas A&M University's National Center for Foreign Animal 
and Zoonotic Disease Defense; and the Biosecurity Knowledge Center 
(BKC). Since Dr. Albright's testimony, the BKC has been established at 
Lawrence Livermore National Laboratory to serve as a national data 
resource network enabling information sharing and threat and 
vulnerability analysis, including results of research conducted at the 
NBACC facility.

    2. How does it fit into the ``Biodefense for the 21st Century'' 
strategy announced by President Bush in April?
    Response: The Presidential directive Biodefense for the 21st 
Century (HSPD-10) outlines four essential pillars of the nation's 
biodefense program. The four pillars are: threat awareness, prevention 
and protection, surveillance and detection, and response and recovery. 
The Department of Homeland Security has a role and responsibility in 
each of these four pillars of the national biodefense program.
    The two programs executed at NBACC will directly or indirectly 
support each pillar.
    The National Bioforensic Analysis Center was specifically 
designated in Biodefense for the 21st Century 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.''
    The Biological Threat Characterization Program will provide the 
scientific basis to characterize biothreats as called for in the Threat 
Awareness section of President Bush's directive which states, ``We are 
building the flexibility and speed to characterize such (biological) 
agents, assess existing defenses, and rapidly develop safe and 
effective countermeasures.''

    3. How will NBACC interact with the intelligence community? Will 
the NBACC and the CIA develop concurrent threat assessments? How will 
conflicting assessments be prioritized?
    Response: The primary conduit for NBACC interaction with the 
Intelligence Community is through the Information Analysis organization 
within DHS's Information Analysis and Infrastructure Protection (IAIP) 
Directorate.
    While NBACC's mission is not to produce intelligence assessments, 
NBACC will support the intelligence community by conducting scientific 
studies and analyses to address gaps in our knowledge of current and 
future biological threats. As appropriate, NBACC will also work with 
operational directorates within DHS (such as those within IAIP) that 
are responsible for disseminating vulnerability data and best practice 
information to industry and to members of the protective community.

    4. Which agency will be ``in charge'' of developing bioterror 
threat assessments?
    Response:
    As described in Biodefense for the 21st Century, the Intelligence 
Community is directed to ``collect, analyze, and disseminate 
intelligence.''
    NBACC will support this mission by providing science-based analysis 
for characterizing the threat, assessing vulnerabilities, determining 
potential impacts, and attributing their use.
    Plans for the NBACC include conducting science-based threat 
assessments of current and future biological threats. Center activities 
might include determining the feasibility of genetic manipulation of 
microorganisms to make them more harmful, and simulated ``red teaming'' 
or table top exercises using bioterror scenarios.

    5. Can you provide us with a succinct list of activities that will 
occur in NBACC laboratories, including those associated with ``science-
based threat assessment''?
    Response: The programs conducted at NBACC will provide knowledge of 
infectious properties of biological threat agents, potential means of 
employment against our nation, effectiveness of countermeasures, 
decontamination procedures, and forensics analyses so policy makers and 
responders can use this information to develop policies, programs and 
technologies to deter or defend against future attacks and save lives.

    The Biological Threat Characterization Program will focus on:
        (1) Developing systematic and rigorous methodology for risk 
        assessment of biothreats.
        (2) Conducting targeted research and laboratory studies to 
        address specific knowledge gaps.
        (3) Investing in infrastructure and procedures to support long-
        term biodefense programs.

    6. Will this work involve the study of genetically-engineered 
pathogens and techniques for making existing pathogens resistant to 
antibiotics and vaccines, more virulent, or otherwise more dangerous? 
How will this work be overseen to ensure it does not violate our 
international treaties against biological weapons or pose a safety 
concern?
    Response: The national biodefense effort across the U.S.Government 
is focused on understanding the potential impact of and defense against 
a terrorist use of biological agents.
    The Biological Threat Characterization Center's mission is to 
provide science-based analysis for characterizing the threat, assessing 
vulnerabilities, and determining potential impacts to guide the 
development of countermeasures. Research and laboratory studies will be 
targeted to address specific knowledge gaps. This may include directed 
studies to evaluate the potential consequences of specific genetically-
modified pathogens that exploit resistance to antibiotics and vaccines.
    All work conducted by the BTCC will be for defensive purposes, as 
permitted by the Biological Weapons Convention (BWC), and will be 
consistent with existing U.S. policy and law.
    The BWC compliance review process will be transparent within the 
U.S. Government and coordinated with other Federal agencies, including 
the Department of State to assure appropriate international authorities 
are advised of BTCC activities as they become relevant to international 
interests. In addition, criteria developed by the National Science 
Advisory Board for Biosecurity, and will be considered as appropriate.
    The Department of Homeland Security is developing formal processes 
to review critical aspects of proposed projects for the BTCC, including 
technical, safety, ethical, policy, and legal issues. This includes 
plans to engage a standing committee within the National Academy of 
Sciences to advise on the technical and scientific aspects of its 
programs.
    According to the Homeland Security Act, HHS is to work 
collaboratively with DHS as it sets goals and policies for medical 
countermeasures development. You have indicated in your testimony how 
this is occurring. DHS is also working with USDA on developing 
veterinary medical countermeasures to counteract agroterrorism.

    7. Can you describe the difference between how these two inter-
agency countermeasures research programs are managed, and whether one 
is working better than the other?
    Response: The management for both medical and agricultural 
countermeasures share a common programmatic framework, as strategic and 
budget planning for both programs is the responsibility of the 
Biological Countermeasures Portfolio within the Science and Technology 
(S&T) Directorate of DHS. S&T also has a major role in inter-agency 
coordination, which includes efforts in a number of venues that were 
mentioned in the testimony before the committee (e.g., several Homeland 
Security Presidential Directives, Counterproliferation Technology 
Coordinating Committee, WMD-Medical Countermeasures Committee, National 
Strategic Plan for Homeland Security Science and Technology, etc.). 
Implementation and execution of individual program elements in S&T is 
the responsibility of either the Office of Research and Development 
(including NBACC, national laboratories, University Centers of 
Excellence), the Homeland Security Advanced Research Programs Agency 
(competitively awarded programs to the private sector, federal 
laboratories, and universities), or the Systems Engineering and 
Development (e.g., operational programs such as Bio-Watch).
    The principal difference between how the two inter-agency 
countermeasures programs are managed is an operational difference. As 
specified by the Homeland Security Act of 2002, DHS S&T assumed 
responsibility (`facilities and liabilities') for the Plum Island 
Animal Disease Center in June 2003, and collaborates with the U.S. 
Department of Agriculture (USDA, Agriculture Research Service, and 
Animal and Plant Health Inspection Service) on a joint strategy for the 
study of foreign animal diseases (e.g., foot-and-mouth disease). DHS 
S&T and the Department of Health and Human Services (HHS) collaborate 
on determining medical countermeasures but DHS S&T does not have 
operational responsibility for any biomedical facility.
    Both collaborative programs are working well in accordance with 
each agency's roles and responsibilities; there is no basis for stating 
`whether one [relationship] is working better than the other.'
    According to the Homeland Security Act, HHS is to work 
collaboratively with DHS as it sets goals and policies for medical 
countermeasures development. You have indicated in your testimony how 
this is occurring. DHS is also working with USDA on developing 
veterinary medical countermeasures to counteract agroterrorism.

    8. Can you describe the difference between how these two inter-
agency countermeasures research programs are managed, and whether one 
is working better than the other?
    Response: Question 8 in the original transmittal of these Questions 
for the Record is a duplicate of Question 7 which has been answered 
above.

    9. How do threat information and vulnerability assessments 
collected by DHS influence the research agendas, if at all?
    Response: Threat characterization is an integral part of the S&T 
strategic planning process. This strategic planning process is informed 
by threat and vulnerability information available through the 
Intelligence Community, law enforcement, and other sources. S&T uses 
this threat information to identify knowledge gaps, against which 
research, development, test, and evaluation (RDT&E) needs are 
prioritized and translated into program execution strategies to fulfill 
operational end-user requirements.
    For example, in the biological countermeasures area, S&T is leading 
a Biothreat Characterization Program for DHS, which will develop 
methodologies for a quantitative risk assessment process to understand 
biothreats, to perform targeted studies to address specific knowledge 
gaps, and to invest in infrastructure and procedures to support 
biodefense programs. The Biodefense Knowledge Center supports the 
Biothreat Characterization Program by collecting biodefense related 
information and expertise that is accessible on short time frames for 
immediate response, and longer time frames for strategic analysis and 
assessments.
    The S&T Directorate is also engaged in understanding the broader 
threat environment. One new effort, denoted all-Weapons of Mass 
Destruction (WMD) Capability Assessment, is collecting and 
disseminating information on the capabilities of various terrorist 
groups, both state and non-state, to develop and deploy chemical, 
biological, nuclear, radiological, cyber, and explosives agents. This 
type of information will have a direct effect on establishing the 
research and development agenda of S&T.
    A second activity, known as the Nuclear Assessment Program and 
transferred to DHS from the Department of Energy, has been analyzing 
communicated nuclear threats since 1977 for such agencies as the 
Federal Bureau of Investigation. Such information is now being used by 
our Radiological/Nuclear Countermeasures portfolio to help guide its 
research agenda.

    10. Are NIH researchers and program managers given access to this 
threat information or allowed to set their own research agendas based 
on this information?
    Response: Upper level NIH management, selected program managers, 
and selected researchers with appropriate clearances and the need to 
know are given access to threat information through a variety of 
mechanisms ranging from interagency working groups to various threat 
briefings. Examples of these interagency working groups include the 
Homeland Security Council/National Security Council-led BioDefense End-
to-End Study and Counterproliferation Technology Coordinating Committee 
Studies, and the Weapons of Mass Destruction Biomedical Countermeasures 
Committee, a working group comprised of the Office of Science and 
Technology Policy, Health and Human Services, Department of Homeland 
Security, and the Department of Defense. This classified information, 
along with unclassified but highly relevant information on current and 
future threats, is then distilled by NIH management into an 
unclassified research strategy and priorities. This strategy is 
published to guide the activities of the broader NIH research 
community. For additional details on the process NIH uses to 
established research strategies and priorities, please contact NIH 
directly.

    11. Right now there is no treatment for ricin exposure--once 
someone is exposed, they will die. And yet recent experience has shown 
that it is relatively easy to gather materials and transmit the toxin 
around the country. This is arguably a more serious threat than anthrax 
because at least anthrax has a vaccine and a course of treatment. So 
who has looked at this and determined it's not important to invest in a 
ricin treatment? How is this decided?
    Response: Actually, there has been work done on developing a 
medical countermeasure for ricin exposure. The DoD completed efficacy 
studies in rodents on recombinant ricin toxin A-chain vaccine 
candidates and down-selected a lead candidate and an alternate. The 
Joint Science and Technology Office for Chemical-Biological defense 
predicts that a ricin vaccine candidate will be ready for transition to 
advanced development in FY 2006.
    It seems that thus far our biodefense strategy has largely been 
driven by the nation's vulnerability to a mass-casualty attack, such as 
terrorist use of smallpox or a large airborne anthrax release. This is 
reflected in the categorization of agents on the A, B, and C priority 
pathogen lists from Centers for Disease Control--with smallpox and 
anthrax on the A list.
    However, the anthrax letter attacks in October 2001 suggest we may 
need to pay attention to small- and medium-sized attacks, too. The 
Congressional Research Service has done such an assessment, and, 
interestingly, anthrax and smallpox were not at the top of the list. 
Instead, they determined glanders was the top concern, currently a 
category B agent.

    12. Are you aware of this assessment, and, if so, what do you think 
of it? Does the current priority listing of pathogens need to be 
reassessed? Has it been reassessed? Who would be responsible for such a 
reassessment and when and how will it get done?
    Response: Yes, we are aware of the Congressional Research Service 
(CRS) assessment. We agree that small and moderate size biological 
events also pose threats. However, more work would be needed to 
determine if the current priority listing of pathogens should be 
changed. As the CRS authors note on p. 53 of their study ``The approach 
taken here is not the only valid approach, and different results may 
occur if different criteria and weighting systems are chosen.'' Also, 
an integrated national strategy must seek the difficult balance of 
responses and associated resource investments against the range of 
threats--from small scale events with more limited consequences to 
moderate-to-large scale events with extensive consequences. Efforts to 
date have been guided by threat prioritizations done by the Centers for 
Disease Control and Prevention (CDC), the Department of Defense (DoD), 
and the Intelligence Community. Threat lists are not static and should 
be periodically reassessed to take into account new intelligence 
information, advances in science and technology, and changes in 
vulnerabilities and defensive concerns. Several such assessments are 
currently ongoing. The CDC is reassessing its threat priority list and 
DHS is conducting formal `material determinations of threat'' as part 
of the BioShield process.
    In addition, DHS is required to provide a formal risk assessment 
every two years with the first due no later than January 2006. This 
will be a structured review process involving a broad range of 
intelligence experts, scientific experts, and analysts with `vetting' 
before a still larger community.
    Project Bioshield requires the Secretary of Homeland Security to 
make a Material Threat Determination before a countermeasure can be 
purchased. Such a determination process is now underway. The Secretary 
of Health and Human Services then determines how the threat should be 
addressed medically and whether an existing countermeasure program 
qualifies for a contract.

    13. What is the process for making a material threat determination? 
How many have been completed to date?
    Response: Material threat determinations are conducted by DHS to 
determine major threats as part of the BioShield process. These 
determinations draw on: available intelligence analysis of the intent 
and capabilities of potential threat organizations; on technical 
assessments of acquiring, producing, and disseminating the agents; and 
on systems analyses of vulnerabilities, potential attack scenarios, and 
resulting consequences of plausible attacks. These studies involve the 
relevant experts across the intelligence, scientific and analysis 
communities. To date, material threat determinations have been 
completed for anthrax and for botulinum toxin.

    Anthrax Vaccine
    14. What is the justification for a new anthrax vaccine (rPA) when 
there is already an FDA-approved vaccine (AVA) that has been used for 
years by the military?
    Response: The current vaccine has a significant limitation with 
regard to manufacturing capacity (currently 6.6 million doses/year). 
Furthermore, limitations regarding the AVA vaccine have been 
articulated in the 2002 report, Anthrax Vaccine: Is It safe? Does It 
Work? from the Institute of Medicine of the National Academy of 
Sciences. The report concluded ``that a new [anthrax] vaccine, 
developed according to more modern principles of vaccinology, is 
urgently needed.'' The new anthrax vaccine should be more readily 
produced and is anticipated to minimize some of the limitations 
associated with AVA.

    15. Is it true that the new vaccine is similar to the existing 
vaccine in terms of safety, efficacy, and delivery? Please consider the 
purpose and results of the CDC anthrax vaccine safety and efficacy 
research program in your answer.
    Response: AVA is licensed as a 6-dose (0, 2, 4 weeks and 6, 12, and 
18 months) vaccine for pre-event only. The new rPA vaccine is 
anticipated to be a 3-dose vaccine (schedule to be determined) and will 
be licensed for both pre-event and post-event situations. There is no 
data at this time to indicate a difference in safety or efficacy. The 
CDC is supporting a study to examine whether the dosing schedule can be 
reduced and the route of administration changed, but that study will 
not be completed until 2007, although some preliminary data may be 
available later this year.

    16. Please explain why the development and purchase of rPA for the 
stockpile is, at this time, a better investment than either a) purchase 
of AVA for the stockpile, or b) research and development of an oral or 
other advanced vaccine.
    Response: Anthrax is a top WMD threat. There is an urgent 
requirement (as determined by the interagency WMD Medical 
Countermeasures subcommittee) for enough vaccine to protect 25 million 
persons. If we were to rely on AVA alone, at current manufacturing 
capacities, this could take over 20 years ((25 million people x 6 
doses/person)/ 6.6 doses/year)). The current manufacturers of rPA 
(under contracts with the National Institute of Allergy and Infectious 
Diseases) have facilities with capacities up to100 million doses/year 
and the current HHS Request for Proposals (proposals are currently 
under review) requires that delivery of 25 million doses be 
accomplished within 2 years of contract award. HHS awarded a contract 
on November 4, 2004 for 75 million doses of rPA. Delivery to the 
Strategic National Stockpile should begin mid-2005. It is likely that 
there will be a significant cost savings with rPA compared to AVA.
    The U.S. Government recognizes the need for the development of a 
third generation anthrax vaccine with an improved delivery system that 
is more compatible with a rapid public health emergency response. 
However, delaying the acquisition program until the development and 
availability of such a product is inconsistent with the national 
security environment.
    The Administration has announced that the Department of Homeland 
Security will be leading the interagency effort to set national 
preparedness goals and ensure we will reach them.

    17. Does DHS have the capability to complete this task for 
bioterrorism preparedness? How much work does it do with state and 
local health departments on a daily basis?
    Response: The President's Biodefense for the 21st Century states 
``The Secretary of Homeland Security . . . is responsible for 
coordinating domestic Federal operations to prepare for, respond to, 
and recover from biological weapons attacks.'' DHS has a significant 
portion of the capability to provide this coordination and is 
increasing this capability where needed.
    Public health biopreparedness and the associated interactions with 
state and local health departments is the primary responsibility of the 
Department for Health and Human Services.

      Questions from Mrs. Kay Granger for Dr. Pensose C. Albright

    1. As your agency proceeds to support the development of WMD 
medical countermeasures, are you aware of, and what are you doing to 
support, the development and deployment of radiological and nuclear 
medical countermeasures?
    Response: The Office of Science and Technology Policy (OSTP) 
National Science and Technology Council, Weapons of Mass Destruction 
Medical Countermeasures Subcommittee, Radiological and Nuclear Threat 
Countermeasures Subgroup is the advisory committee that is providing 
priorities and guidance to Project Bioshield in the area of anti-
radiation drugs. Procurement of some such drugs may be authorized using 
funds from the Project BioShield appropriation, or funds of the 
Strategic National Stockpile, which is managed by HHS. DHS participates 
on this interagency group which is currently developing a national 
acquisition strategy. Additionally, coordination of research and 
development in the areas of both radioprotectants and radiation 
treatment drugs is taking place on many levels including the 
Counterproliferation Technology Coordinating Committee (CTCC). DHS 
supports the development of radiological and nuclear medical 
countermeasures by participation in the aforementioned activities but 
does not directly provide funding for development efforts.
    2. Q01994: As follow up, are you aware of a product, 5-
androstenediol, or ``HE-2100,'' that is currently the lead candidate 
for the first radiation sickness drug, which has proven to repopulate 
bone marrow destroyed by radiation exposure? If so, what are you doing 
to help accelerate the approval and stockpiling of this or a similar 
drug for the protection of the American people and the military?
    Response: A number of potentially effective drugs for use as 
radiological and nuclear medical countermeasures, including 5-
androstendediol, have been brought to our attention. As discussed 
above, DHS S&T is supportive of the activities which lead to the 
approval and stockpiling of anti-radiation drugs. In the specific case 
of protection to the American military, the Armed Forces 
Radiobiological Research Institute (AFRRI) is charged with conducting 
research in the field of radiobiology and related matters essential to 
the operational and medical support of the U.S. Department of Defense 
and the military services. AFRRI has funded development and testing of 
5-androstendediol and DHS S&T has been briefed on these results.

      Questions from Mr. Bob Etheridge for Dr. Penrose C. Albright

    The Administration included $250 million for a Biosurveillance 
Initiative in its Fiscal Year 2005 budget request. Half of this project 
will be managed by the Centers for Disease Control, and the other half 
by the Department of Homeland Security. The Information Analysis 
Directorate is supposed to have major responsibilities, but I 
understand they have asked the Science and Technology Directorate to 
develop the systems they will use.
    Response: The FY 2005 President's Budget asks for $129M in DHS to 
support the BioSurveillance Initiative. Of that $129M, $118M goes 
directly to the Science and Technology Directorate to: expand the 
BioWatch Program in the top threat cities; to pilot a BioWarning and 
Incident Characterization System (BWICS) in two of the BioWatch cities; 
to accelerate the development of next generation bio-detection systems; 
and to initiate R&D on biological detection systems for protecting 
critical food nodes. The remaining $11M of the $129M is to go to the 
Information Analysis and Infrastructure Protection (IAIP) Directorate 
for the development of a National Biosurveillance Integration 
capability which will integrate state of health monitoring (human, 
animal, and plant) with environmental monitoring (air, agriculture, 
food and water), and with intelligence and threat data to enable the 
earliest possible detection of an event and to help guide the response 
to any such event. S&T has offered and is currently conducting the 
design study for this information system, which will be transferred to 
IAIP in FY 2005.

    1. Has IAIP submitted this request to you, and when?
    Response: By agreement of the Secretary's Office in February 2004, 
S&T is sponsoring the design of the National Biosurveillance 
Integration System (NBIS) to be completed in FY 2005. The statement of 
work for this system was developed through an interagency process. 
Quotations were reviewed by an interagency team and the design contract 
was awarded. A Conceptual Design Review was held in September, a 
Preliminary Design Review in October, and a Final Design Review in 
December, 2004. Actual implementation of the design will be transferred 
to IAIP in FY 2005.

    2. When do you expect to begin working on DHS? plan for 
implementing the biosurveillance initiative?
    Response: As noted above, the DHS role in the Biosurveillance 
Initiative consists of several elements, the planning for which has 
been on-going for sometime now. We are in the process of piloting the 
planned BioWatch expansion, with the pilot to be operational in New 
York City this fiscal year and with deployment to the other top threat 
BioWatch cities schedule for FY 2005 and early FY 2006. A systems 
design phase for the BWICS element was `kicked off' this past summer. 
The additional funding to accelerate the development of the next-
generation bio-detection program will be used to augment the 15 awards 
that have recently been made, or are in process, in this area. The 
requirements for the detection systems for critical food nodes are 
currently being developed through analysis of representative food 
contamination scenarios. And, we have awarded a contract for the design 
of the National Biosurveillance Integration System (NBIS) and expect to 
complete the design effort in December 2004.

    3. Have you sketched out a role for state and local governments, or 
even the private sector, in collecting information? Is any funding set 
aside, to your knowledge, to include them?
    Response: State and local governments play a significant role in 
BioWatch and BWICS and a significant portion of the funding in these 
programs will go to support them. The NBIS will integrate information 
streams provided largely by other Federal Agencies in their respective 
areas of responsibility, e.g., CDC will provide information related to 
public health, USDA to agriculture. NBIS may also employ data streams 
from other relevant sources.

    4. Are you confident such a system can work?
    Response: The Generation 1 BioWatch system has been operating 
successfully for over a year. The key elements of this Generation 2 
expansion have been demonstrated in the laboratory and are currently 
being piloted. We are confident that they will work, though there will 
be the usual lessons learned to optimize their performance.
    The National Biosurveillance Integration System is a new endeavor, 
with three main goals: to enable earlier detection of a biological 
event; to provide situational awareness to better guide the response to 
such an event; and, to facilitate the sharing of needed information at 
the Federal, state, and local level. To accomplish this, NBIS 
integrates new and emerging information streams from sector specific 
agencies. There is little question that combined access to these 
diverse information streams will significantly increase our situational 
awareness and improve the sharing of information to at all levels. That 
leaves the question of how much we can advance the detection timeline. 
Studies over the past few years, including analyses against historical 
data sets and limited field data have indicated that the use of non-
traditional indicators (e.g. emergency room chief complaints) can 
significantly advance the detection timelines, as can the correlation 
of diverse events (e.g the linkage of dead crows with West Nile 
disease). Therefore, we fully expect that NBIS and the related sector 
sources will provide an advance in the detection timeline and that this 
advance will increase as we gain additional operational experience with 
various algorithms and data sources against real world backgrounds.

      Questions the Honorable Jim Turner for Dr. Shelley A. Hearne

    1. Do we have a coherent biodefense strategy today? How should we 
build one? What should the core elements be? How should its overall 
goals and objectives be set? What might they look like?
    The Administration and Congress have addressed bioterrorism threats 
by developing and funding programs such as Bio-Sense, BioShield and 
BioWatch. However, Trust for America's Health (TFAH) remains conceed 
that there is no overarching federal ``BioGame Plan.'' We worry that 
there are overlapping jurisdictions, lack of coordination among various 
federal agencies, and no plan for intra- and interagency training or 
rapid deployment of resources in the event of an attack. We believe 
that Congress should identify a lead agency to develop and oversee a 
comprehensive BioGame Plan that clearly delineates the roles and 
responsibilities of each federal agency and. its state and local 
counterparts.
    The most important components of a national biodefense strategy for 
public health should include:
         Coordination among the agencies at the federal, state 
        and local level to insure a clear delineation of duties and 
        assure that system gaps are covered.
         State specific bioterrorism plans that are routinely 
        exercised at the local, state and regional level with federal 
        accountability for performance.
         All state public health laboratories must have minimum 
        capacities to respond, 24 hours a day/7 days a week, to the 
        full spectrum of public health emergencies, including 
        terrorism, without compromising critical and routine 
        investigations, such as testing drinking water or food 
        supplies.
         Minimum standards for the public health workforce, 
        including specific targets per capita for specialists (i.e., 
        one epidemiologist/500,OOO people); training requirements and 
        credentialing. With the growing workforce shortage, strategic 
        federal investments in the public health workforce are required 
        to protect the U.S. population from a wide range of health 
        threats.
         Modem and up-to-date communications systems are vital. 
        As we learned with anthrax and SARS, communicating with a 
        shaken public is key to alleviating natural fears that arise 
        with an unexpected threat or an emerging illness. The Health 
        Alert Network (HAN), a federally coordinated system between the 
        CDC and state/local health departments, has the potential to 
        fill this current communications gap.
    By using advanced technological tools, HAN will allow for real-time 
coordination in situations where even seconds matter. The HAN plays a 
vital role in the nation's state of readiness and timetables to 
completion and activation must be accelerated.
         Creation of a nationwide disease tracking command 
        center at CDC. Because of the current ``disease du jour'' 
        (i.e., SARS one month, and Monkeypox the next), CDC risks 
        establishing dozens of different databases that are not 
        directly linked or integrated, and may in fact, be redundant. 
        This paradigm also limits the public health community's ability 
        to understand the interconnections between diseases and 
        possible causes. TFAH recommends that Congress provide the 
        mandate, resources and support to establish a centralized 
        disease tracking center within CDC. This would include tracking 
        animalborne diseases, chronic diseases, such as cancer and 
        asthma, events related to bioterrorism, and environmental 
        risks.
    Although there is agreement among public health experts on many of 
the core elements of a well-prepared public health system, there are 
still several critical goals and objectives that continue to need 
discussion. Accordingly, TFAH recommends that the President, in 
consultation with Congress and public health experts, should convene a 
White House summit that will develop a concrete vision for a 21st 
century American public health system and identify the resources needed 
to make it a reality. TFAH believes that such a summit should create a 
blueprint for a public health system that is designed to meet America's 
current and emerging health threats.
    Specifically, the summit should address all essential public health 
concerns, including, bioterrorism, chemical, and radiological 
preparedness, known and emerging infectious diseases and chronic 
disease prevention and control. At the same time, we believe the summit 
should foster a long-overdue dialogue about the human and financial 
resources required to implement needed changes and to guarantee 
accountability at every level of the public health system.

    Your organization's December 2003 report, Ready or Not? Protecting 
the Public's Health in the Age of Bioterrorism, found that ``only two 
states are at the highest preparedness level required to receive and 
distribute. . .supplies needed to provide . emergency vaccinations and 
antidotes.'' But my understanding is that every state has to submit a 
stockpile distribution plan to the federal government.

    2. How accurate is this statistic? What is wrong with the state's 
plans? Are they unworkable? Haven't they been exercised?
    The Department of Homeland Security (DHS) and CDC evaluate the 
states' Strategic National Stockpile (SNS) distribution capabilities 
and assign them a preparedness rating of red, amber or green. A red 
rating is the worst, while green is the best. In TFAH's report, ``Ready 
or Not? Protecting the Public's Health in the Age ofBioterrorism,'' 
only two states had obtained green status as of November 2003. From 
recent public reports, TFAH has learned that an additional state 
(Louisiana) has now obtained green status, although our organization 
has not conducted a formal review. There are also unsubstantiated 
reports from government officials that several states have lost ground 
recently in their SNS status, but TFAH does not have specific 
quantitative information.
    For TFAH's December 2004 state-by-state report on preparedness, we 
will attempt to update the SNS information. For up-to-date accuracy, 
TFAH would recommend that the Committee directly request CDC and DHS to 
provide a tabulated chart on the number of states that have obtained 
green, green minus, amber plus, amber, red plus and red status for the 
SNS.
    States have developed SNS distribution plans, which are reviewed 
and . assessed by DHS through intensive on-site teams. DHS should be 
applauded for establishing performance standards and evaluation 
methods, which is an unusual practice in the public health field. The 
challenge states are facing in preparedness for stockpile distribution 
are numerous, ranging from lack of sufficient workforce to limited 
funds. As noted in our testimony, many states had planned on tapping 
their National Guard units for distribution, which may now be 
unavailable due to deployment in Iraq and elsewhere. In other 
instances, states have not done sufficient training or exercising with 
respect to stockpile distribution. There have also been complaints that 
as SNS responsibilities were transferred from CDC to DHS, there were 
significant delays in funding, guidance and the ability for DHS 
representatives to conduct evaluations.

    You discussed in your testimony your concerns about a workforce 
sbortage in distribution of the stockpile. We understand that the 
Secretary's recent reprogramming request would include funding for 21 
cities to employ the U.S. Postal Service to help disseminate 
antibiotics in the case of a terrorist event.

    3. Can you discus the pros and cons of this approach? Given the 
traumatic experience of many postal workers during the 2001 anthrax 
attacks, do you think they are prepared or even wiling to take on a 
duty that might put them at risk?
    By all indicators, this nation is unprepared on multiple levels for 
a major bioterrorism attack. One critical weakness relates to how to 
deliver vital medical materials, such as antibiotics, antidotes and 
vaccines, to large segments of the population. Almost all states fail 
to be fully prepared to receive the Strategic National Stockpile (SNS), 
in large part because of a limited distribution capacity. In TFAH's 
past reports, the enormous public health workforce shortage is cited as 
a major factor for this preparedness shortcoming. Rather than making an 
investment in revitalizing the diminished public health workforce, the 
Administration is proposing a unique strategy to tap into the U.S. 
Postal Service's delivery experience and network.
    The ``pro'' argument for this approach is that it potentially 
provides officials with a vast delivery network that is well-organized 
and geographically familiar with the community. Given that many states 
had developed distribution plans relying on National Guard Units, short 
term alternatives are needed. But this approach has significant 
vulnerabilities, which again highlights the need for a national 
commitment to rebuild our public health workforce to sufficient levels, 
rather than relying on stopgap measures.
    The concerns about relying on the U.S. Postal System during a 
bioterrorism event are multiple, particularly during broad scale 
quarantine/isolation. Public health and emergency response experts are 
gravely concerned about how the American public would respond during 
this type of crisis; fears range from distrusting government 
information/recommendations to civil unrest. Research, public opinion 
polls and past experience highlight that ``trust'' is the most critical 
factor influencing the public's response and that the healthcare 
provider community is the most trusted resource. In the midst of a 
major pandemic or bioterrorism event, response workers tasked with 
distributing . medical supplies to isolated/quarantined homes will need 
to be far more than deliverymen, but instead will need to be well-
trained, familiar with health issues and trusted.
    TFAH cannot assess if U.S. Postal Service employees will be 
prepared or willing to travel to potentially contaminated locations. 
However, we would like to point out that even if provided with 
extensive training, individuals inexperienced with infectious disease 
may not respond rationally or well to a perceived health threat. The 
HIV/AIDS crisis is a vivid reminder that despite widespread information 
on the virus's transmission, many non-health care workers refused to 
interact with infected individuals. In addition to transporting 
critical medical supplies to homes, postal workers would be playing 
dual roles--providing information about the health emergency and giving 
assurance during a crisis. A family cordoned off from the world will 
inevitably have specific questions about possible symptoms, doses for 
children, elderly or immune-suppressed individuals, why isolation is 
necessary, etc. These front line responders need to be well trained in 
crisis management that builds on their fundamental health skills if a 
system of quarantine and isolation is to work.
    A better short term option would be to consider a network of home 
health care providers, ambulance services, EMS and even pharmacists who 
have better fundamental training in health matters. Or at a minimum, a 
bioterror response plan should ensure that these health professionals 
are integrated into an emergency response system. But in the long term, 
a serious reinvestment is needed to refortify and bolster our nation's 
public health workforce.
    If current workforce demographic trends are left unchecked, they 
will have an adverse affect on the capacity of state health agencies to 
carry out their mission; including responsibilities that have continued 
to expand since the events of September 11, 2001, and the ensuing 
anthrax attacks. Hiring freezes at the state and local levels, due in 
part to budget deficits and competition from higher-paying private 
companies contribute to the workforce shortages.
    TFAH supports legislation that has been proposed to begin to 
address this critical public health need. The Public Health 
Preparedness Workforce Development Act of 2004 is designed to alleviate 
workforce shortages in federal, state and local government public 
health agencies. The bill establishes two new programs for students 
pursuing degrees in public health disciplines--a new scholarship 
program and a loan repayment program.
    Examples of disciplines related to public health that would be 
covered by the legislation include: laboratory sciences, epidemiology, 
environmental health, health communications, information sciences, 
public administration, social work, and nursing.

Cuts in Preparedness Funding
    4. If enacted, what will be the effect on bioterrorism preparedness 
of the $105 million reduction in state and local bioterrorism capacity 
grants?
    The proposed funding cut of $1 05 million in state and local 
capacity grants, (11 % from fiscal year 2004 appropriated levels), will 
seriously erode state and local preparedness across the nation. The 
cuts proposed for fiscal year 2005 will be especially hard-hitting 
because, if enacted, the $105,000,000 reduction in state and local 
preparedness dollars would follow the Department of Health and Human 
Service's reprogramming of $55 million appropriated by Congress in 
fiscal year 2004 for bioterrorism capacity grants to the CDC Cities 
Readiness Initiative, Biosurvelliance Initiative and quarantine 
acceleration efforts.
    The reprogramming of these funds has resulted in a reduction of 
$1.085 million for most states (please see attached chart of state-by-
state cuts resulting from the reprogramming), which significantly 
weakens the ability of local and state public health officials to 
respond to a health emergency. For example, according to the 
Association of State and Territorial Health Officials (ASTHO), negative 
effects of the reprogramming request may include: reductions in 
workforce; delays in the creation of surge laboratory capacity; 
elimination of planning activities for the Strategic National 
Stockpile; cancellation of planned training events and statewide 
exercises for a potential chemical attack; and discontinuation of the 
implementation of the statewide Health Alert Network.
    The proposed $105 million cut in fiscal year 2005 funding would be 
nearly' double that of that of funds that were just reprogrammed away 
from state and local capacity grants and the impact on public health 
agencies to respond to a bioterror attack would be even more draconian. 
That is why TFAH believes that even in these tight fiscal times, 
Congress must restore the proposed $105 million cut. Otherwise further 
readiness efforts at the state and local levels will be derailed. TFAH 
recommends that Congress make a long-term investment in public health 
preparedness and authorize an independent review to determine whether 
current expenditures are sufficient. Experts note that at a minimum, 
the nation requires a $1 billion annual commitment for the next several 
years in order to achieve the appropriate level of public health 
security .
    To assure that this investment is well-spent,CDC, in consultation 
with state and local health officials and outside experts, including 
those from other federal agencies like the Departments of Defense and 
Homeland Security, must define measurable standards for comprehensive 
preparedness that all state and major local health departments should 
meet.
    The General Accounting Office has reported that no hospital funded 
through federal preparedness grants is able to meet the benchmark of 
serving a surge of at least 500 patients.

    5. Why do we remain so far from effective mass casualty 
preparedness? What will it take to get our hospitals up to a minimum 
standard? What should that standard look like?
    Based on input from the University of Pittsburgh's Center for 
Biosecurity, at present, most hospitals in the U.S. would have great 
difficulty dealing with 50 critically ill victims of a bioterrorist 
attack, let alone 500. As was evident in Toronto hospitals during the 
SARS outbreak last year, highly contagious diseases have tremendous 
impact on hospital function, and in fact, hospitals caring for SARS 
patients or victims of a bioterror attack with smallpox, for instance, 
would be more likely to experience a decrease in overall capacity, not 
an increase in capacity. Most hospitals have only the numbers of 
doctors and nurses they need for routine purposes. If more doctors, 
nurses paramedics, medical technicians, cafeteria workers, sanitation 
workers, etc., were needed in crisis, hospitals would need to have 
systems in place to bring on more staff from the community or 
elsewhere.
    Further complicating matters, in an actual event, many hospitals 
may not be able to keep even their usual staffing commitments--regular 
health care workers may be fearful of going to work or of leaving their 
family members during such a crisis, or, as was the case in SARS, some 
may become ill themselves from the disease at hand. Serious and 
integrated planning would need to take place to create the kind of 
emergency staffing systems needed to keep hospitals up and running in 
the case of a bioterror event resulting in mass casualty.
    Hospitals typically have sufficient medical supplies and 
ventilators to serve routine needs, no excess. While the Strategic 
National Stockpile (SNS) may be able to provide some of these key 
supplies to hospitals in the time of crisis, most hospitals do not 
currently know exactly what is in the SNS, how quickly or by what 
mechanism they would receive components of the SNS, how decisions would 
be made to allocate such components, etc. As noted earlier, few states 
have reliable systems to distribute components of the stockpile to 
hospitals.
    Recognizing this vulnerability, Congress made important new funding 
commitments for hospital preparedness over the last few years. 
Unfortunately, these funds were divided across the hospital community 
throughout the U.S. without consideration for risk and need, thereby 
dangerously diluting the resources. Few U.S. hospitals have received 
serious funding to prepare for bioterrorism. One major hospital in New 
York City, located only blocks from the World Trade Center site, 
received $40,000 in funding last year to address all of its 
biopreparedness and terrorism preparedness needs. These days $40,000 
would pay for about half of one senior nurse's salary.
    Commensurate with this, hospital preparedness is treated in many 
communities as an avocation, with work done after hours by a dedicated 
few. To be able to cope with an event producing 500 or more victims, 
hospitals need to develop preparedness programs built on reliable 
systems that are testable, scaleable, and capable of ``dual use'' for 
meeting a full spectrum of challenges. This will require a sustained 
and more substantial funding stream with realistic guidance. Currently, 
HRSA guidance covers a broad range of initiatives, but present funding 
levels are unrealistic to accomplish few, if any.

    One of the ongoing concerns that we have when trying to determine 
state and local preparedness for a terrorism event is our focus on 
biological readiness. Recent reports of a possible terrorism event seem 
to suggest that a dirty bomb or chemical attack, similar to the recent 
ricin attack in the Senate office buildings, are just as possible if 
not more likely

    6. Do you think we are prepared for a chemical or radiological 
attack? If not, what do we need to do to become better prepard?
    From a public health perspective, the U.S. is woefully unprepared 
for a chemical or radiological attack. With respect to chemical 
terrorism, a report issued by TFAH in June 2003 found that state public 
health laboratories are ``dangerously unprepared'' to fulfill their 
roles as first responders charged with identifying chemical agents used 
in an attack. The report, ``Public Health Laboratories: Unprepared and 
Overwhelmed,'' examined the capabilities of state public health 
laboratories, a crucial component of our defense and response system, 
and found that a majority of labs are in need of modernization and 
stabilized funding support. Labs are responsible for identifying the 
chemical weapons used in an attack, which then drives the critical 
treatment, containment, and clean up decisions. The report found gaps 
in planning, coordination, equipment, training, safeguards, workforce, 
and environmental testing capacity for chemical agents.
    TFAH's recommendations for improving public health lab capacity to 
respond to a chemical or radiological attack include: .
         Enhanced Capacity: By the end of 2004, each state 
        should have at a minimum, testing capabilities for priority 
        potential chemical and biological weapons agents.
         Modem Communications: All state public health 
        laboratories must establish an effective communications network 
        incorporating clinical laboratories, hospitals and private labs 
        that evaluate patients directly.
         More Expertise: Each state laboratory should have at 
        least two trained PhD-level microbiologists and one PhD-level 
        chemist to ensure effective biological, chemical and 
        environmental testing capacity.
         Enhanced Federal Commitment: Federal funding for 
        improving the readiness of public health laboratories to 
        respond to biological, radiological and chemical attacks should 
        be $200 million in fiscal year 2005. This level of funding is 
        essential if labs are to have the ability to conduct clinical 
        testing for potentially dangerous chemicals, such as ricin, 
        cyanide, nerve agents and pesticides.
         CDC Leadership: CDC must have the authority to ensure 
        capacity, collaboration and consistent methodology for clinical 
        testing for chemical exposures. The National Center for 
        Environmental Health should be supported to advance 
        methodologies, develop a training system and establish 
        performance measures for state laboratories. DHS should partner 
        with CDC and Environmental Protection Agency (EPA) to 
        prioritize chemical agents for environmental and clinical 
        laboratory methodologies.
         Joint Training. Key federal agencies including DHS, 
        EPA, and CDC should collaborate to develop a joint training 
        exercise with states and first responders to prepare for 
        chemical attacks. The May 12, 2003 ``Topoff2'' emergency 
        response exercise had components to examine nuclear and 
        biological threats, but did not include a chemical scenario. To 
        date, there has not been a substantial training exercise to 
        test national and local readiness in the event of such an 
        attack.

    Increasingly, there are some who see bioterrorism preparedness as a 
trade-off. That is, funding for public health preparedness for 
infectious diseases means less money for other functions, such as 
community health, elderly care or obesity reduction plans. Focusing on 
a new anthrax or tularemia vaccines means less of a focus 'on 
tuberculosis or malaria.

        7. Are there concerns real? Given our experience to date, is it 
        possible to make bioterrorism funding truly ``dual-use?'' What 
        can we do better to achieve an all-hazards approach?
    The tragedies of September 11 and the subsequent anthrax attacks 
shook the nation--and highlighted in the most dramatic way possible 
that our country was not ready to respond to large scale health crises. 
Even before the threats of bio--and chemical terrorism, the nation's 
state and local health agencies were already stretched too thin trying 
to manage everything from infectious disease outbreaks to preventing 
chronic disease like cancer and asthma, with too few resources.
    Over the course of the last year alone, local, state, and federal 
health officials have responded--and contained--SARS, monkeypox, flu, 
and West Nile virus outbreaks, and the recent ricin incident in the 
Senate, while simultaneously working to prevent chronic diseases and 
address the everyday health needs of all Americans.
    TFAH believes that rather than concentrating solely on bioterrorism 
or responding to each ``disease du jour'' crisis individually, public 
health preparedness efforts must be focused on an ``all-hazards'' or 
``dual-use'' approach. This approach would focus on strengthening the 
fundamentals of our public health defenses, including laboratory 
capabilities and communications and response procedures.
    To achieve the optimum all-hazards approach to public health 
preparedness, TFAH's specific recommendations include:
         CDC must formally authorize states to use federal 
        preparedness funds to support an ``all-hazards'' approach to 
        preparedness that simultaneously addresses the potential for 
        biological, chemical, radiological and natural disease 
        outbreaks.
         CDC, in consultation with state and local health 
        officials and outside experts, must define measurable standards 
        for comprehensive preparedness that all states and major local 
        health departments should meet.
         Congress should provide long-term commitment and 
        oversight toward ensuring the nation achieves adequate and 
        sustainable public health security. As such, Congress should 
        authorize an independent review to assess whether current 
        expenditures--at the federal, state and local levels--are 
        sufficient.
         Health security requirements must be established, 
        including mandates and accountability measures to ensure all 
        citizens are adequately protected.
         CDC must be required to track state and local funding 
        and expenditures on critical public health functions, 
        particularly those involving federal support. Unfortunately, 
        there is mounting evidence to indicate that severe state budget 
        cuts dilute the impact of the federal preparedness investment. 
        Concerned that federal dollars should supplement--and not 
        supplant--state and local funding streams, Congress urged the 
        Health and Human Services Secretary to guard against such 
        actions, but this ``maintenance of effort'' needs to be 
        enforced.
         CDC should independently verify that health emergency 
        performance standards are being met at the federal, state and 
        local levels.
    As stated earlier, that is why TFAH also recommends that the White 
House, in consultation with Congress, convene a national summit on the 
future of public health to develop a cohesive and proactive approach to 
public health protection.

    The Administration has developed a Biowatch program, deployed in 
cities throughout the country, and a new Bio-surveillance initiative, 
which is to involve building complex new information systems both at 
DDS and at the Centers for Disease Control, known as BioSense. The 
concept of detecting a release as early as possible makes a lot of 
sense in terms of protecting the public. But DDS itself admits that the 
Biowatch system may be too costly and labor intensive. Some scientists 
have suggested the syndromic surveillance, the basis of BioSense, has 
not been proven to work.

    8. Are these systems ready to be fielded, or do we need more 
research and to develop better systems first? Are the resources we are 
devoting to this system well spent?
    The BioWatch Program is intended to provide early warning of a mass 
pathogen release, which inherently makes sense in light that human 
symptoms from bioterrorism may not appear for days after exposure. 
Numerous questions have been raised about the program's inherent 
efficacy, costs, the strategic siting of detectors, workforce needs and 
the overall ability to coordinate responses with the local public 
health agencies.
    One major issue is the strategic location of the detectors. 
Building upon the nation's existing air quality monitoring system, the 
biopathogen detectors are reportedly combined with EPA's infrastructure 
for tracking ambient air pollutants, such as ozone and nitrous oxides. 
Efforts are underway to expand BioWatch to locations in all major 
metropolitan statistical areas, but these locations do not generally 
coincide with where a pathogenic agent would be released. For example, 
EPA's air monitors are positioned on large building rooftops and 
airport outdoor properties to capture ambient air pollutants. For 
terrorists with high impact designs, pathogens are more likely to be 
released in lower, more closely contained areas with dense populations. 
For early warning purposes, BioWatch may have greater value positioned 
in high target areas, such as subways, large arenas, and ventilation 
systems for significant or landmark buildings. Already, its limited 
applications come with a significant price tag: annual operating costs 
are estimated at $1 million per city, after the initial $1 million 
investment per location.
    In addition, numerous laboratory issues abound with BioWatch. 
First, the pathogen monitors are highly labor intensive, requiring 
samples to be collected every 24 hours from the aerosol samplers and 
are analyzed using a polymerase chair reaction (PCR) technique. Lab 
capacity is already stretched thin in most state and local public 
health agencies. We speculate, that in reality, BioWatch results may 
take days to determine, raising questions about its early warning 
capacity .

    9. Are these the best we can do in detection, or are there other 
options we should be considering?
    Numerous federal and independent reports have noted the gaps in 
basic public health preparedness, from laboratory capacity to rapid 
response teams to disease surveillance systems. Significant 
improvements are needed in public health preparedness that far 
outweighs the potential benefits of the BioWatch programs. A cost 
benefit analysis for preparedness would most likely reveal that more 
lives would be saved by investing in state or the art disease 
surveillance systems, adequate medical distribution systems, trained 
and sufficient numbers of public health workers, strong communications 
operations, and routine exercises for all hazards. While BioWatch is a 
technological advance, its limited coverage and high labor and resource 
costs, make it a questionable investment in light of greater 
bioterrorism preparedness needs.
    At this stage, BioWatch is of limited value and should be 
revaluated in the context of the broader strategic needs of the 
nation's bioterrorism defense.

    The rapid increase in funding for biodefense has led to the 
building of more biocontainment labs and many more researchers working 
with these dangerous pathogens. It seems that this could lead to a 
greater risk of theft or accidental release of these pathogens.
    10. Are you concerned about the safety and security of these labs? 
Are we doing enough to ensure the safety and security of biodefense 
research in this country?
    Although the safety and security of state public health labs is of 
concern, there are additional overarching issues with respect to the 
role of labs during a public health crisis. The nation's 2,000 state 
and local public health laboratories, together with hospitals and local 
health departments, would quite literally be 'front-line' defenders in 
case of a terrorist attack. In our 2003 study, TFAH found that 30 years 
of inadequate funding and the absence of federal oversight have 
rendered public health laboratories unable to respond appropriately to 
more traditional hazards, let alone acts of terrorism. An under-
prepared workforce, a shortage of trained laboratorians, and old, often 
outdated facilities lacking the latest equipment, reagents and other 
tools, render public health laboratories dangerously unprepared to 
respond to a public health emergency. Public health specialists point 
out that, while the technologies and expertise exist to manage 
bioterror threats, laboratories lack the resources to access them.

           Questions Mr. Ed Markey for Dr. Shelley A. Hearne

    As you know, the only federal program that directly coordinates 
local first responders to deal with a bioterror attack is the 
Metropolitan Medical Response System. This program gives direct grants 
to 125 US cities to coordinate fire, police, hospital and public health 
officials for terror attacks with large numbers of casualties. However, 
the President's fiscal year 2005 budget contains no money for the 
program.
        1. Do you agree with the Administration's efforts to eliminate 
        MMRS?
        2. How important in your opinion is coordination among local 
        first responders--hospitals, fire, police and public health 
        officials--in mitigating the effects of a' bioterror attack in 
        an urban area?
    The goal of Metropolitan Medical Response System (MMRS) is to 
support local jurisdictions by enhancing and maintaining all-hazards 
response capabilities with respect to a mass casualty incident, 
including but not limited to, a terrorist attack during the early 
hours. TFAH believes that the basic tenet of this program--enhancing 
the coordination of activities between the major players involved in 
responding to a mass casualty is critical and we applaud this 
coordination where it is working well.

       Questions from Mr. Bob Etheridge for Dr. Shelley A. Hearne

    You have called for the federal government to define measurable 
standards for comprehensive preparedness that all states and major 
local health departments should meet for preparedness. This is exactly 
what the interagency process the Department of Homeland Security is 
supposed to manage.
    1. How would you advice the Department to accomplish this task? 
What would ``preparedness'' look like? How would we know we were 
prepared until something happened and we could measure our response?
    Over two years after the state bioterrorism preparedness program's 
launch, at least three separate initiatives are underway throughout the 
federal government to establish performance measures for readiness for 
a major public health emergency. The Centers for Disease Control and 
Prevention (CDC) is in the pilot phase of testing evidence-based 
performance goals for states public health disaster preparedness. The 
Department of Health and Human Services (HHS) has separately been 
assessing potential benchmarks to evaluate state programs. The 
Department of Homeland Security (DHS) recently embarked on a 
comprehensive preparedness exercise which brought together experts 
representing a wide variety of the ``preparedness'' world including 
public health organizations. The goal of exercise was to create a 
``universal task list'' for states and communities. According to public 
health experts, the exercise was based on various scenarios that were 
not well designed because they failed to accurately reflect what would 
happen during a major health emergency. Throughout the exercise, goals 
and public health roles were uncertain within the context of the 
comprehensive preparedness initiative.
    Unfortunately, states are implementing the third year of the grant 
program without overall preparedness standards in place. Further, it 
appears that DHS, HHS and CDC are not coordinating these efforts so 
that state and local health departments would ultimately have one set 
of measurable standards to abide by. TFAH would strongly recommend that 
the CDC and HHS directly coordinate a performance measure system for 
state and local preparedness, and subsequently build it in and test it 
through DHS's comprehensive preparedness effort. Using realistic 
biological, chemical or radiological scenarios, DHS could effectively 
test public health readiness with the CDC/HHS performance measures. 

          HHS Reallocation of $59.4 million in State Emergency Preparedness Funds for FISCAL YEAR 2004
----------------------------------------------------------------------------------------------------------------
                        CDC FISCAL                                      Redirected $ for Cities
                         YEAR 2003                      Percent Cut       Readiness Initiative         TFAH BT
        State            Emergency    Dollar Amount of  From FISCAL ------------------------------- Preparedness
                       Preparedness     Cut to State     YEAR 2003                                  Score, Scale
                           Funds                           Funds                                     of  1-10**
----------------------------------------------------------------------------------------------------------------
Alabama                 $14,056,645        -$1,085,000          -8%  ................  ...........            6
----------------------------------------------------------------------------------------------------------------
Alaska                    6,284,107         -1,085,000          -17  ................  ...........            3
----------------------------------------------------------------------------------------------------------------
Arizona                  15,755,035         -1,085,000           -7          Phoenix    $1,280,000            5
----------------------------------------------------------------------------------------------------------------
Arkansas                 10,461,043         -1,085,000          -10  ................  ...........            2
----------------------------------------------------------------------------------------------------------------
California               55,589,662         -1,085,000           -2                 Los A2,670,000            7
----------------------------------------------------------------------------------------------------------------
                       ............  .................  ...........        San Diego     1,220,000  ............
----------------------------------------------------------------------------------------------------------------
                       ............  .................  ...........    San Francisco       940,000  ............
----------------------------------------------------------------------------------------------------------------
Colorado                 13,979,790         -1,085,000           -8           Denver       820,000            5
----------------------------------------------------------------------------------------------------------------
Connecticut              11,960,524         -1,085,000           -9  ................  ...........            4
----------------------------------------------------------------------------------------------------------------
Delaware                  6,614,378         -1,085,000          -16  ................  ...........            5
----------------------------------------------------------------------------------------------------------------
District of Columbia     11,162,901  .................      No Cuts               DC       830,000            3
                                                              to DC
----------------------------------------------------------------------------------------------------------------
Florida                  38,181,999         -1,085,000           -3            Miami       710,000            7
----------------------------------------------------------------------------------------------------------------
Georgia                  22,034,847         -1,085,000           -5          Atlanta       740,000            3
----------------------------------------------------------------------------------------------------------------
Hawaii                    7,486,672         -1,085,000          -14  ................  ...........            4
----------------------------------------------------------------------------------------------------------------
Idaho                     7,676,282         -1,085,000          -14  ................  ...........            3
----------------------------------------------------------------------------------------------------------------
Illinois                 24,923,148         -1,085,000           -4          Chicago     2,150,000            5
----------------------------------------------------------------------------------------------------------------
Indiana                  17,416,386         -1,085,000           -6  ................  ...........            4
----------------------------------------------------------------------------------------------------------------
Iowa                     10,941,890         -1,085,000          -10  ................  ...........            3
----------------------------------------------------------------------------------------------------------------
Kansas                   10,476,095         -1,085,000          -10  ................  ...........            3
----------------------------------------------------------------------------------------------------------------
Kentucky                 13,245,815         -1,085,000           -8  ................  ...........            2
----------------------------------------------------------------------------------------------------------------
Louisiana                14,059,595         -1,085,000           -8  ................  ...........            5
----------------------------------------------------------------------------------------------------------------
Maine                     7,603,092         -1,085,000          -14  ................  ...........            3
----------------------------------------------------------------------------------------------------------------
Maryland                 15,915,365         -1,085,000           -7  ................  ...........            7
----------------------------------------------------------------------------------------------------------------
Massachusetts            17,972,524         -1,085,000           -6           Boston       840,000            5
----------------------------------------------------------------------------------------------------------------
Michigan                 25,278,581         -1,085,000           -4          Detroit     1,030,000            3
----------------------------------------------------------------------------------------------------------------
Minnesota                15,101,600         -1,085,000           -7      Minneapolis       710,000            5
----------------------------------------------------------------------------------------------------------------
Mississippi              10,795,501         -1,085,000          -10  ................  ...........            2
----------------------------------------------------------------------------------------------------------------
Missouri                 16,424,504         -1,085,000           -7             St. Louis  690,000            4
----------------------------------------------------------------------------------------------------------------
Montana                   6,834,837         -1,085,000          -16  ................  ...........            3
----------------------------------------------------------------------------------------------------------------
Nebraska                  8,485,811         -1,085,000          -13  ................  ...........            6
----------------------------------------------------------------------------------------------------------------
Nevada                    9,251,219         -1,085,000          -12                 Las Veg790,000            5
----------------------------------------------------------------------------------------------------------------
New Hampshire             7,552,202         -1,085,000          -14  ................  ...........            5
----------------------------------------------------------------------------------------------------------------
New Jersey               22,248,528         -1,085,000           -5  ................  ...........            5
----------------------------------------------------------------------------------------------------------------
New Mexico                8,710,551         -1,085,000          -12  ................  ...........            2
----------------------------------------------------------------------------------------------------------------
New York                 27,794,404         -1,085,000           -4              NYC     5,100,000            6
----------------------------------------------------------------------------------------------------------------
North Carolina           21,630,396         -1,085,000           -5  ................  ...........            5
----------------------------------------------------------------------------------------------------------------
North Dakota              6,290,025         -1,085,000          -17  ................  ...........            5
----------------------------------------------------------------------------------------------------------------
Ohio                     28,082,405         -1,085,000           -4        Cleveland       770,000            4
----------------------------------------------------------------------------------------------------------------
Oklahoma                 12,031,404         -1,085,000           -9  ................  ...........            3
----------------------------------------------------------------------------------------------------------------
Oregon                   12,039,235         -1,085,000           -9  ................  ...........            3
----------------------------------------------------------------------------------------------------------------
Pennsylvania             29,933,326         -1,085,000           -4     Philadelphia     1,350,000            3
----------------------------------------------------------------------------------------------------------------
                       ............  .................  ...........       Pittsburgh       690,000  ............
----------------------------------------------------------------------------------------------------------------
Rhode Island              7,147,493         -1,085,000          -15  ................  ...........            6
----------------------------------------------------------------------------------------------------------------
South Carolina           13,232,255         -1,085,000           -8  ................  ...........            4
----------------------------------------------------------------------------------------------------------------
South Dakota              6,536,811         -1,085,000          -17  ................  ...........            4
----------------------------------------------------------------------------------------------------------------
Tennessee                16,651,663         -1,085,000           -7  ................  ...........            7
----------------------------------------------------------------------------------------------------------------
Texas                    48,310,184         -1,085,000           -2          Houston     1,650,000            4
----------------------------------------------------------------------------------------------------------------
                       ............  .................  ...........           Dallas     1,190,000  ............
----------------------------------------------------------------------------------------------------------------
Utah                      9,618,011         -1,085,000          -11  ................  ...........            4
----------------------------------------------------------------------------------------------------------------
Vermont                   6,242,254         -1,085,000          -17  ................  ...........            3
----------------------------------------------------------------------------------------------------------------
Virginia                 19,584,849         -1,085,000           -6  ................  ...........            5
----------------------------------------------------------------------------------------------------------------
Washington               17,146,134         -1,085,000           -6          Seattle       830,000            6
----------------------------------------------------------------------------------------------------------------
West Virginia             8,649,835         -1,085,000          -13  ................  ...........            4
----------------------------------------------------------------------------------------------------------------
Wisconsin                15,955,629         -1,085,000           -7  ................  ...........            2
----------------------------------------------------------------------------------------------------------------
Wyoming                   6,000,636         -1,085,000          -18  ................  ...........            4
----------------------------------------------------------------------------------------------------------------
** Source:             TFAH's 12/03 Report, Ready or Not? Protecting the Public's Health in the Age of
                       Bioterrorism http://healthvamericans.org/state/bioterror/Bioterror.pdf
----------------------------------------------------------------------------------------------------------------

    Responses to Questions for the Record from Major General Lester 
                             Martinex-Lopez

    USAMRMC Responses to Representative Cox's Select Committee Follow-
on Questions
    Question: 1. How do threat information and vulnerability 
assessments collected by DHS or DOD influence the research agendas, if 
at all?
    Answer: 1. Within the formal DOD process, the Joint Requirements 
Office--CBRND (JRO-CBRND) integrates threat information and 
vulnerability assessments from all sources and reviews the DoD CBD 
Program. Results of these reviews, conducted with all Services 
participating, are documented in the Joint Service Modernization and 
Joint Service RDA Plans. These documents form the basis for the 
consolidated Program Objectives Memorandum (POM). Once requirements for 
warlighting capabilities are determined, doctrinal, training, or 
organizational solutions (nonmaterial solutions) are explored, and when 
these cannot fulfill the need, equipment or materiel solutions are 
sought through the materiel acquisition process. Based upon such 
capability-based analysis, research program strategies are assessed and 
planning guidance is modified by the CB S&T manager at the Defense 
Threat Reduction Agency to incorporate potential technological 
opportunities and needs-based technology maturation efforts into the 
Department's research agenda. Specifics of how threat information and 
vulnerability assessments from DHS are incorporated in this process are 
best directed to the JRO-CBRND.
    In parallel to this official process, the interagency coordinating 
mechanisms described in my response to your question number three also 
act to shape the detailed research agenda.

    Question: 2. Are MRMC researchers and program managers given access 
to this threat information or allowed to set their own research agendas 
based on this information?
    Answer: 2. In medical CB S&T, MRMC researchers are provided with 
threat information from multiple sources and this includes raw as well 
as formal, finished intelligence. Formal intelligence information may 
be restricted in distribution, but it does shape program and proposal 
development. MRMC researchers are not allowed to set their own research 
agendas based on threat information, although they do recommend 
programs and develop competitive proposals based on such information. 
Program management of medical CB S&T is the responsibility of DTRA, 
which was assigned responsibility for management and integration of CBD 
S&T on 22 April 2003. Program guidance in medical CB S&T is provided by 
DTRA directly to program executors/performers. Guidance delivered to 
program performers is developed from DTRA's coordination with JRO-CBRND 
and the Joint Program Executive Office for CB Defense so that joint 
Service capabilities and requirements and materiel development 
strategies are appropriately addressed in developing research agendas. 
MRMC researchers respond to guidance provided through the DTRA program 
managers by participating in program development, developing research 
proposals and executing those that are approved for funding. Final 
coordination and impacts of proposed program expenditures are discussed 
between the DTRA program office and MRMC, setting the path for science 
program execution in the current budget year.

    Question: 3. Do the National Institute of Allergy and Infectious 
Diseases and USAMRIID coordinate on setting research agendas? How would 
NIAID know whether USAMRIID is pursuing the same pathogen?
    Anwser: 3. Using available intelligence, each agency will 
internally develop and approve its own threat list and research agenda 
based upon missions and responsibilities. We can expect some threats 
will be unique to one agency and other threats will be shared. A 
committee formed by the partners of the National Interagency Biodefense 
Campus will review and discuss the lists, looking for unique and 
overlapping threats. Unique threats will be the responsibility of the 
specific agency; however, the expertise and facilities of other 
agencies will be available to enhance execution of research and 
operational programs to address the threats. For overlapping threats, 
the involved agencies will discuss their approach to the threat, 
allowing performance of different research and operational programs by 
different agencies, thereby sharing cost while developing products that 
will address the threats identified by more than one agency. Needless 
duplication and redundancy will be avoided in scientific programs 
through oversight and coordinating efforts of one or more scientific 
and/or operational committee(s) formed by the partners of the National 
Interagency Biodefense Campus. Each agency will develop its own 
programs based upon its missions and responsibilities. The committee 
will review the programs, looking for redundancy. If redundancy is 
found, through a joint process, different aspects of the program will 
be assigned to the agencies with the most expertise and superior 
facilities in each area. This process will encourage collaboration and 
mutual fulfillment of research and operational goals, ultimately 
developing products that can be used by multiple agencies.
    In addition to the forums and processes provided by the Interagency 
Campus, other formal and informal coordination mechanisms will 
continue. NIAID and USAMRMC leadership participate in activities of the 
R&D Sub-Group of the Interagency Working Group on Weapons of Mass 
Destruction Medical Countermeasures of the Chemical, Biological, 
Radiological, and Nuclear Health Countermeasures Subcommittee of the 
Homeland and National Security Committee of the National Science and 
Technology Council. Additionally, USAMRMC's scientific workforce will 
remain active in providing programmatic and scientific advice to NIAID, 
and in responding to NIAID program announcements. NIAID program 
leadership has visited our laboratories for program and scientific 
briefings on a regular basis. These more formal interactions are 
facilitated on a personal level by the prevalence of ex-military 
scientists within the program leadership of NIAID, DHHS and DHS. In 
addition, the DTRA Medical Chemical and Biological Defense Research 
Program has initiated efforts to harmonize their science program with 
leadership within the Biodefense Research Program of the NIAID.

    Question: 4. Right now there is no treatment for Ricin exposure--
once someone is exposed, they will die. And yet recent experience has 
shown that it is relatively easy to gather materials and transmit the 
toxin around the country. This is arguably a more serious threat than 
anthrax because at least anthrax has a vaccine and a course of 
treatment. So who has looked at this and determined it's not important 
to invest in a Ricin treatment? How is this decided?
    Answer: 4. Although specific, FDA approved medical countermeasures 
against ricin are not available at the present time, it is not 
necessarily true that exposure leads to death. However, after signs/
symptoms appear, treatment for ricin aerosol exposure is limited to 
supportive care to treat acute pulmonary edema and respiratory 
distress. Supportive care for oral intoxication includes activated 
charcoal administration and intravenous fluid and electrolyte 
replacement. Although ricin has historically held a lower level 
priority as a military threat, based on intelligence estimates and 
doctrinal reliance on early detection, physical protection and rapid 
decontamination, the resource intensive nature of such care, and 
generally poor prognosis, has been a primary consideration in driving a 
continuing research and development effort for medical countermeasures.
    The best medical solution for populations at high risk to ricin 
exposure would be vaccination because: (1) small amounts of vaccine can 
provide safe and lasting protection against exposure to large amounts 
of toxin; (2) vaccines require minimal space and logistical support; 
and (3) vaccines can be administered easily and far in advance of 
exposure. Although there is presently no approved human vaccine for 
ricin, two experimental vaccines have been developed in the DoD Medical 
Biological Defense Research Program (MBDRP). The candidates have not 
been tested in humans and do not have current FDA IND status. USAMRIID 
maintains approximately 30,000 troop effective doses of cGMP dGA 
(deglycosylated A chain) vaccine candidate that has demonstrated a 90% 
protection level against 1015 LD50 of aerosolized ricin toxin in non-
human primates. This earlier generation vaccine was developed at a time 
when human efficacy testing would have been the only way to achieve 
licensure, and has remained ``on-the-shelf'' for contingency use as an 
investigational product. Although the advent of the FDA's ``two-animal 
rule'' has technically opened the way for further development, the 
manufacturing process of dGA is outdated and likely precludes further 
advanced development A new generation ricin vaccine candidate is 
presently under development under Defense Technology Objective (DTO) 
CB.46. This candidate is produced by recombinant technology and is 
projected for transition to the Joint Program Executive Officer for 
Chemical and Biological Defense in FY2006.
    Research on pretreatment or early treatment (hours to days before 
or after exposure) has demonstrated initial proof of concept in animals 
that large amounts of experimental antibodies given as a therapeutic 
may mitigate ricin toxicity when the toxin is directly injected. 
However, administration of pre-made antibodies is expected to be less 
effective against ricin aerosol exposure. The ``window of opportunity'' 
for post-exposure treatment with antibodies is narrow because ricio 
binds and is taken up rapidly by exposed cells lining the airways. An 
acceleration of these efforts by the DOD would require better 
definition of the military use for prophylactic antibodies (vs. 
vaccination) and, as warranted, research and development to produce new 
human therapeutic antibodies. Although lack of clear military utility 
for such a therapeutic may limit the military investment in this 
approach, the USAMRIID is available to partner with other funding 
agencies is furthering this effort. The development and availability of 
a ricin therapeutic would certainly have utility for U.S. military 
personnel exposed to the threat, however a therapy would have even 
greater applicability for medical defense in a civilian population 
where the use of prophylactic vaccines may be more difficult to 
justify.

    Questions from the Honorable Jim Turner for Anna Johnson-Winegar

    Question: 1. Do we have a coherent biodefense strategy today? How 
should we build one? What should the core elements be? How should its 
overall goals and objectives be set? What might they look like?
    Answer: As of today (June 2004), this nation does not have a 
coherent biodefense strategy in place. While there has been some effort 
to develop parts of a comprehensive plan, the planning process has not 
been inclusive, and the communication of what has been proffered has 
fallen far short of what is needed. The United States does not need a 
classified plan that is not available to or understood by the public; 
this will not be effective in allaying fears and concerns. In order to 
build a better plan, the administration, working with the appropriate 
agencies and experts must reach out in a more proactive fashion. 
Convening Blue Ribbon panels of experts is one step that can take 
advantage of the various independent thinkers who have been dealing 
with all aspects of biodefense. Additional Congressional hearings also 
provide another forum for obtaining information, although these 
sessions are often limited by time and the results are not well 
publicized. The overall goals and plans for a biodefense strategy 
should be developed in a consensus from the component parts. A 
suggested list (although not comprehensive) would include the 
intelligence community; medical community; policy experts; 
communication specialists; and leaders in the scientific and 
engineering fields. There should be a phased approach, identifying 
those objectives that can be reached in the short term (less than one 
year); mid-term (one to three years); and long term (greater than three 
years). Periodic reports should be issued so that an unbiased, 
professional analysis can be generated about the progress being made 
and the availability of funding, personnel and facilities dedicated to 
the plan.

    Increasingly, there are some who see bioterrorism preparedness as a 
trade-off. That is, funding for public health preparedness for 
infectious diseases means less money for other functions, such as 
community health, elderly care or obesity reduction plans. Focusing on 
a new anthrax or tularemia vaccine means less of a focus on 
tuberculosis or malaria.

    Question: 2. Are these concerns real? Given our experience to date, 
is it possible to make bioterrorism truly ``dual-use''? What can we do 
better to achieve an all-hazards approach?
    Answer: There must be a balance between the emphasis on infectious 
diseases (both naturally occurring and bioterrorist disseminated) with 
chronic diseases. The research needs of both communities have common 
areas of interest and this is the path that must be pursued to make the 
work truly ``dual-use''. One easy example is the need for basic 
research that more clearly defines the immune system and its response 
to pathogens (regardless of the source of the pathogen). Other examples 
include development of generic drugs that can be used to treat a 
variety of diseases (both acute and chronic), and development of more 
rapid diagnostic systems.
    Funding for public health preparedness for infectious diseases also 
helps build the infrastructure that will be available to address other 
concerns. As we learn more about how pathogens interact with the body 
and how they enter the body (via aerosol dissemination or by mosquito 
bite), we can apply this knowledge to a broader array of diseases. It 
doesn't have to be one or the other! There is plenty of work to be done 
and much can be useful in broad application.
    To achieve a better all-hazards approach, we have to stop thinking 
about one disease at a time. The threat list of bioterrorism agents IS 
long enough, but the number of diseases on the naturally occurring 
infectious list, added to those considered chronic is daunting. More 
emphasis should be placed on multi-valent vaccines, non-specific immune 
enhancers, and awareness of general health issues.

    The Administration has developed a Biowatch program, deployed in 
cities throughout the country, and a new biosurveillance initiative, 
which is to involve building complex new information systems both at 
DHS and at the Centers for Disease control, known as BioSense. The 
concept of detecting a release as early as possible makes a lot of 
sense in terms of protecting the public. But DHS itself admits that the 
Biowatch system may be too costly and labor intensive. Some scientists 
have suggested that syndromic surveillance, the basis of BioSense, has 
not been proven to work.

    Question: 3. Are these systems ready to be fielded, or do we need 
more research and develop better systems first? Are the resources we 
are devoting to this system well-spent?
    Answer: The systems that are fielded today need substantial 
improvement. First, they are point detectors. The design of these 
systems only enables filter collection of air samples from a limited 
area in the immediate vicinity of the collector. Therefore, it is 
critical to place the detector system in the optimal location. Without 
knowing where an attack may occur, this is simply a guess. There are a 
number of computer projections that determine the minimal number of 
systems needed to cover a given area (a city, or a military 
installation), but the number in use today is far below the minimum for 
each location. The systems are indeed labor intensive, and require 
sophisticated laboratory analysis of the filters to determine presence 
of a biological agent. Sustainment costs for these systems are very 
high. The resources being spent on these systems is not well spent 
since they are not fully developed, are prone to false positives, 
require extensive quantities of consumable expensive reagents and are 
not necessarily located in the right places.

    Question: 4. Are these the best we can do in detection, or are 
there other options we should be considering?
    Answer: The systems in use today in the Biowatch program are among 
the best available. However, the assays in use are based on specific 
reagents, which, by definition, limit the scope of the system. In other 
words, you have to know what you're looking for, then develop the right 
reagents, and maintain the system accordingly. As the list of potential 
I bioterrorist threats increases, more reagents must be developed and 
added to the existing array. While the reagents available today cover 
most of the highest probability threats, they are certainly not 
comprehensive. In addition, the level of sensitivity needs to be 
improved by several orders of magnitude to approach maximal 
effectiveness. A bigger concern is the lack of absolute correlation 
between competing systems developed by different laboratories. There is 
currently no federal agency or organization that is the certifying 
group for these types of reagents. When different results are obtained 
(one positive, one negative), the credibility of detector systems comes 
into question. More research is needed in stand-off detection for 
biological agents. Approaches include various types of spectroscopy and 
lasers to probe and interrogate potential agent clouds. These types of 
systems are not ready for even preliminary fielding, but should be the 
option of choice for future work.
    With regard to biosurveillance, I agree that this has not yet been 
proven to work. In concept, the idea is good, but it will be costly to 
develop the information systems that can collect and coordinate the 
input from private physicians, hospitals, schools, drug stores, and all 
the other contributing elements. Since the possibility exists that the 
first cases of a bioterrorist attack may show up in very dispersed 
areas (i.e. assume the release of an agent in an airport with symptoms 
not beginning for 24 hours), it will be critical for BioSense to 
capture data from extensive geographical areas. While the CDC seems the 
appropriate organization to collect and analyze the data, they are not 
currently staffed to undertake this responsibility. Submission of data 
to the system will be voluntary and there is no real mechanism to 
monitor compliance. The costs associated with this type of passive 
system have not been fully evaluated. Finally, issues of patient 
confidentiality have not been suffiiently addressed.

    In your testimony, you mentioned that even with perfect detectors, 
we need a robust ``concept of operations'' to make that detector part 
of a real working system that will improve our biosecurity. That seems 
to be exactly what we lacked during the anthrax attacks. Once the 
attack was detected here or in Florida, or New York, no one seemed to 
know quite how to respond, or what to tell the public.

    Question: 5. Do we have a better ``concept of operations'' today 
behind our civilian biodetection systems, particularly Biowatch?
    Answer: I believe we have made progress in establishing a better 
concept of operations. Coordination with state and local officials has 
been an important advance in our understanding of how results from 
Biowatch would be reported and utilized throughout the nation. Various 
training exercises have been completed which provide the foundation for 
a comprehensive approach. These efforts must be continued so that 
confidence in the systems can be improved.

    Most biodefense programs before 9/11 were carried out by the 
Department of Defense. You pointed out in your testimony that funding 
for medical countermeasures has grown exponentially following 9/11, but 
that this growth has primarily occurred at other agencies, NIAID now 
has a $1.7 billion budget, far larger than USAMRIID's $66.3 million, 
and even larger than DOD's entire chemical and biological defense 
research budget, including medical and non-medical projects, of $359.3 
in FY04.

    Question: 6. Let's say you were back at DOD, but with a budget 
of$7.3 billion, the combined NIAID and Bioshield budgets. What would 
you do differently than we are doing today?
    Answer: As you are aware, the NIAID and BioShield budgets encompass 
only medical research and procurement of medical countermeasures. I 
would reallocate more research funding into the non-medical components 
of a comprehensive program. This would include more work on stand-off 
biodetection; development of better decontamination solutions; and more 
efforts in modeling and simulation to understand dispersion of 
biological agents. There are many unanswered questions about aerosol 
dissemination of biological agents. Much of the work today relies on 
data generated 50 years ago or more, including estimates of the LD50 
for humans (e.g., is the estimate of 10,000 anthrax spores the correct 
LD50 for humans, or is it lower in some individuals?), early clinical 
signs for many agents, and estimates about survivability of biological 
agents in various delivery forms. In addition, I would rearrange the 
emphasis of the medical funding to focus on development of appropriate 
animal models and to expand the funding available for necessary 
clinical trials for safety and immunogenicity of potential new 
countermeasures. As I stated during the hearing, I think the NIAID 
approach toward basic science that is investigator initiated will not 
lead to many new products. Conversely, the BioShield legislation allows 
for procurement of medical countermeasures that are near FDA licensure. 
There is an obvious gap in the work since there is not any focus on 
pivotal animal studies and development of surrogate markers to 
establish immunity in humans. Making effective transitions from 
laboratory scale basic research into production quantities of effective 
countermeasures should be a high priority for developmental funding.

    Government Owned- Contractor Operated Facilities

    Question: 7. What is a GOCO facility for medical countermeasure 
development?
    Answer: During the first Gulf War (1990-91), the DOD needed larger 
supplies of several medical countermeasures for biological agents, 
primarily anthrax vaccine and botulinum toxoid. The only manufacturer 
at the time (the Michigan Department of Public Health, subsequently 
BioPort) had limited facilities and while they worked diligently to 
increase production, they were unable to meet the needs of the United 
States military, much less any Allies or coalition partners. The DOD 
commissioned a special task force (code named Project Badger) that 
contacted all commercial vaccine manufacturers to assess their interest 
and willingness to produce extra doses of these critical vaccines. None 
were responsive due to limited availability of facilities; concerns 
about liability and indemnification; concerns about long-term funding 
for the effort; concerns about safety; need for bio-containment 
laboratories (BL-3 required) and lack of specialized, dedicated 
equipment needed for these products. (There is an FDA regulation that 
any product made from a spore-forming organism, such as Bacillus 
anthracis or Clostridium botulinum must be produced in dedicated 
equipment that can not be used subsequently for other vaccines). .
    Ultimately, the Project Badger report recommended that DOD pursue 
the option of establishing a stand-alone Vaccine Production Facility. 
The best option appeared to be a facility that was government owned 
(and funded), but .operated by contractors since DOD lacked sufficient 
personnel to staff such a facility. The complete Project Badger report 
has now been declassified and is available for your review. Following 
the Project Badger recommendation, the Army developed costs, evaluated 
potential locations, and ultimately, the DOD submitted a budget for a 
VPF in the POM. A small amount of funding ($25 million) was 
appropriated in FY02 for design studies, but after further review, the 
project was deleted from the DOD budget request.

    Question: 8. How would the use of this kind of facility differ from 
the BioShield approach? How would it differ from the approach NIH is 
taking to product development?
    Answer: The GOCO approach requires construction of a stand alone 
facility that will be owned by the government. Both the BioShield and 
NIH approaches rely on use of existing industrial facilities. Although 
the pharmaceutical firms seem opposed to the GOCO approach, citing the 
availability of capacity already existing, this belies that fact that 
each year industry has difficulty meeting existing market demands. 
Recent shortages in tetanus, pertussis, and flu vaccines support the 
perception that there is no excess capacity available for biodefense 
vaccine work. While scheduling production runs of various products is 
not a trivial exercise, the profitability and marketability of a 
specific item seem to be high priorities. There is genuine concern that 
the existing facilities will be taxed (at over 80% capacity) to meet 
current needs for widely used products, ranging from influenza vaccine 
to the childhood vaccines.
    The GOCO approach also differs from current alternatives in that 
both NIB and the BioShield approach require a specific solicitation for 
each product. The RFP process is time consuming and mandates that 
potential contractors spend time developing a proposal and negotiating 
final specifications. In the GOCO approach, a long-term contract (10 
years or more) is envisioned, with annual funding for the workforce 
salaries, supplies, validation and licensing costs, etc. The actual 
product(s) to be produced each year can be decided on as-needed basis, 
rather than projecting far in advance. This provides much more 
flexibility to the government. Also, by making a long-term commitment 
to a GOCO, the government sends a strong signal about sustained support 
for medical countermeasures for biological agents. Referring back to 
the ``dual-use'' question above, the GOCO facility should be considered 
a national asset. While development and production of bio-defense 
products would be the first priority, this facility would be available 
as a back-up to industry for either surge production of a particular 
vaccine, or as an alternative should a current production facility be 
closed for renovation or because of FDA violations identified during 
routine inspections. Since the nation finds itself in a position where 
there are fewer licensed vaccine manufacturers than ever before, and 
since many products are made in only one facility (raising 
vulnerability), the concept of a back-up facility should be considered 
an attractive alternative.
    The GOCO facility should be designed as a multi-functional 
building, with several types of production suites (e.g., bacterial 
fermentation; tissue culture in roller bottles; etc); pilot development 
scale laboratories; common areas for bottling and storage of final 
products; appropriate containment laboratories for animal testing of 
candidate vaccines; and other required functions. The understanding is 
that the facility would be totally regulated and inspected by the Food 
and Drug Administration, thereby assuring high quality products with 
external review. Validation of the facility and all the equipment and 
processes is a complex process and could take several years after 
completion and trial runs. The facility would not normally compete with 
private industry, thus allaying their concerns about profit, but would 
serve as an adjunct to the current concepts.

    Question: 9. Should Congress still consider a GOCO facility?
    Answer: While there are still issues to be resolved, such as which 
department should be in charges of a GOCO facility, I firmly believe 
this is the right approach for the government. The key features of a 
GOCO facility include the following:
         government control of production, availability, and 
        distribution
         flexibility for emergency production technologies
         meets national security priorities for bio-defense 
        vaccines
         overcomes limited industry interest in bio-defense 
        products
         existing government labs provide supporting research 
        and development
         operating contractor would provide specialized 
        expertise in vaccine production and regulatory requirements
    At the time of the original proposal in the early to mid 1990's, a 
GOCO facility was estimated to cost only $125 million for construction. 
The revised estimate prepared by the DOD in 2000 estimated $856.5 
million for design and construction, with annual operating costs to be 
added to this figure. As time passes, the costs will only increase, and 
the nation will be at the mercy of the fragile, profit-motivated 
pharmaceutical industry to make the bio-defense vaccines that are 
needed. In my opinion, Congress should strongly consider appropriating 
funds for a GOCO facility for bio-defense medical countermeasures.

    The National Biosecurity Analysis and Countermeasures Center 
(NBACC) at the Department of Homeland Security will be responsible for 
assessing the threat of bioterrorism. I'm interested in hearing from 
you about the mission of this institution.

    Question: 10. What capabilities will NBACC bring that DOD did not 
have during the last several decades? Is this a wholly new function, or 
something of a duplication of national security functions, but for 
homeland defense?
    Answer: The Department of Defense program in biological defense 
over the past decades (since 1969 when President Nixon ended the U.S. 
offensive biological warfare program) has been purely defensive in 
nature. It has been a reactive, not a proactive program. The 
capabilities envisioned for NBACC position it to be more proactive in 
conducting the appropriate kinds of studies and analyses to validate 
threats and make more realistic predictions about the use of biological 
agents. For example, the work done following the anthrax attacks in the 
fall of 2001 on how the anthrax ,spores were released through the 
letters and the mail sorting machines, as well as how effectively 
radiation could be used to kin the spores in the mail, is work that 
does not fall under the mission of the DOD biodefense program. Other 
work needs to be completed on assessing the infective doses of some 
biological agents via the respiratory route since current estimates are 
based on outdated methods for enumerating organisms and assessing 
viability. In addition, NBACC should assume the responsibility for 
maintaining data bases with information on multiple strains of 
organisms such as anthrax. The DNA sequencing of many pathogens is 
underway, and NBACC should use this data in their forensic 
responsibilities. While there may be some overlap between the national 
security function of DOD and the NBACC mission, I believe the NBACC 
mission surpasses the limited role of the DOD. Clearly, there must be a 
coordination of efforts between these agencies, as well as the 
intelligence community for NBACC to be successful.

    Another issue I want to ask you about is how NBACC should carry out 
its duties. There is significant concern about the potential for new 
technologies in biology to be applied to create a more dangerous 
bioterror threat. Many are concerned that these experiments should 
never be tried, and, if they occur accidentally, the results kept 
secret.

    Question: 11. How exactly should NBACC assess the assessment of 
this threat? Should NBACC attempt to create some of these more 
dangerous pathogens, or refine techniques for weaponization? Is there a 
situation where such experiments are legitimate?
    Answer: Since there are no restrictions on terrorists, it would be 
prudent for an organization such as NBACC to be able to analyze 
experiments that have been reported in the open scientific literature 
to determine widespread applicability. One immediate example that comes 
to mind would be for NBACC to perform the studies that determine 
whether currently available vaccines (such as anthrax vaccine) are 
effective in protecting against all strains of the organism that exist 
in nature. Following this, efforts should be made to obtain samples of 
genetically modified organisms (such as that reported by the Soviets) 
to test the effectiveness of our detectors and medical countermeasures. 
In the absence of such confirmatory data, we are only deluding 
ourselves about the breadth and depth of our protection. Reproducing 
the laboratory work of others, and conducting some well controlled 
experiments to evaluate the ease of production of new more potent 
organisms are appropriate for the mission of NBACC, in my opinion.
    There is a great deal of controversy in the scientific community 
about restrictions on publishing data on biological agents. While the 
``publish or perish'' philosophy exists in

    Question: 15. Should we be worried about Russian biological 
programs? Is there more the United States should be doing at former 
bioweapons sites in the former Soviet Union?
    Answer: I have limited knowledge of the activities the United 
States is pursuing in the former Soviet Union, and would defer this 
question to those with more expertise. However, my belief is that the 
former Soviet Union (along with other counties) maintains a robust 
research program in biological warfare. The limited program underway to 
convert former bioweapons sites to peaceful objectives is slow due to 
administrative issues and reluctance to accept new goals and 
objectives. Retraining scientists and technicians will take a matter of 
years, and the ultimate success of the program depends upon continued 
financial support coupled with appropriate levels of monitoring for 
safety and security. In my opinion, the individuals participating in 
these programs can be motivated by financial security, the opportunity 
to publish their findings in the open scientific literature, and the 
opportunity to participate as equals in international scientific 
conferences.

      No Responses to the Following Questions have been Recieved:

   Questions for the Record from Ranking Member Jim Turner, for Dr. 
                            Anthony S. Fauci

    1. The Administration's recent ``Biodefense for the 21st Century'' 
strategy document indicated that HHS is responsible for the 
``anticipation of future threats?'' What will HHS do in this area and 
how will it differ from the work at NBACC?
    According the Homeland Security Act, HHS is to work collaboratively 
with DHS as its sets goals and policies for medical countermeasures 
development. You have indicated in your testimony how this is 
occurring. DHS is also working with USDA on developing veterinary 
medical countermeasures to counteract agroterrorism.
    2. Can you describe the difference between how these two inter-
agency countermeasures research programs are managed, and whether one 
is working better than the other?
    3. How do threat information and vulnerability assessments 
collected by DHS influence the research agendas, if at all?
    4. Are NIH researchers and program managers given access to this 
threat information or allowed to set their own research agendas based 
on this information?
    5. Do the National Institute of Allergy and Infectious Diseases and 
USAMRIID coordinate on setting research agendas? How would NIAID know 
whether USAMRIID is pursuing the same pathogen?
    6. Right now there is no treatment for Ricin exposure-once someone 
is exposed, they will die. And yet recent experience has shown that it 
is relatively easy to gather materials and transmit the toxin around 
the country. This is arguably a more serious threat than anthrax 
because at least anthrax has a vaccine and a course of treatment. So 
who has looked at this and determined it's not important to invest in a 
Ricin treatment? How is this decided?
    It seems that thus far our biodefense strategy has largely been 
driven by the nation's vulnerability to a mass-casualty attack, such as 
terrorist use of smallpox or a large airborne anthrax release. This is 
reflected in the categorization of agents on the A, B, and C priority 
pathogen lists from Centers for Disease Control--with smallpox and 
anthrax on the A list.
    However, the anthrax letter attacks in October, 2001 suggest we may 
need to pay attention to small- and medium-sized attacks, too. The 
Congressional Research Service has done such an assessment, and, 
interestingly, anthrax and smallpox were not at the top of the list. 
Instead, they determined glanders was the top concern, currently a 
category B agent.
    7. Are you aware of this assessment, and if so, what do you think 
of it? Does the current priority listing of pathogens need to be 
reassessed? Has it been reassessed? Who would be responsible for such a 
reassessment and when and how will it get done?

    Project Bioshield
    8. Will the implementation of Project Bioshield change the way 
NIAID spends its biodefense budget?
    9. Will you continue to fund advanced development of 
countermeasures, such as the new anthrax and smallpox vaccine projects, 
or will you leave it to the guaranteed market under Bioshield to lead 
to development?
Anthrax Vaccine
    10. What is the justification for a new anthrax vaccine (rPA) when 
there is already an FDA approved vaccine (A V A) that has been used for 
years by the military?
    11. Is it true that the new vaccine is similar to the existing 
vaccine in terms of safety, efficacy, and delivery? Please consider the 
purpose and results of the CDC anthrax vaccine safety and efficacy 
research program in your answer.
    12. Please explain why the development and purchase of rPA for the 
stockpile is, at this time, a better investment than either (a) 
purchase of A V A for the stockpile, or (b) research and development of 
an oral or other advanced vaccine.
    NIB has obligated nearly $750 million for the construction of new, 
high security biodefense labs around the nation, so-called BSL-3 and 
BSL-4 labs. In addition, the CDC, the Department of Agriculture, the 
Department of Defense, the Department of Energy, and the Department of 
Homeland Security are all planning to construct new facilities.
    13. What study was conducted to determine our requirements for BSL 
laboratory space? What were the conclusions of that study in terms of 
how much space is needed?
    14. Communities are rightly concerned about the possible escape of 
a harmful pathogen from one of these labs. We need only reference the 
recent escape of SARS from a Chinese research lab to know that it is 
possible. What protocols are in place to protect communities from an 
accidental release of a harmful or lethal pathogen?

Questions for the Record from Representative Nita Lowey for Dr. Anthony 
                                S. Fauci

    1. Can you please tell the Committee what is being done to support 
the development and deployment of radiological medical countermeasures? 
No response has been received.
    It is my understanding that the Department of Health and Human 
Services has issued two requests for information (RFI)--one from the 
Centers for Disease Control and Prevention in February 2004 and one 
from the National Institute of Allergy and Infectious Diseases in April 
2004--regarding the development of radiological countermeasures.
    2. Considering the Attorney General's recently mentioned threats, 
can you please explain the need for two different RFIss rather than a 
request for proposals (RFP)? No response has been received.

                                 
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