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TOWARDS A NATIONAL BIODEFENSE STRATEGEY

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

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html
SELECT COMMITTEE ON HOMELAND SECURITY

CHRISTOPHER COX, California, Chairman 

JENNIFER DUNN, Washington 

C.W. BILL YOUNG, Florida 

DON YOUNG, Alaska 

F. JAMES SENSENBRENNER, JR., Wisconsin 

W.J. (BILLY) TAUZIN, Louisiana 

DAVID DREIER, California 

DUNCAN HUNTER, California 

HAROLD ROGERS, Kentucky 

SHERWOOD BOEHLERT, New York 

LAMAR S. SMITH, Texas 

CURT WELDON, Pennsylvania 

CHRISTOPHER SHAYS, Connecticut 

PORTER J. GOSS, Florida 

DAVE CAMP, Michigan 

LINCOLN DIAZ-BALART, Florida 

BOB GOODLATTE, Virginia 

ERNEST J. ISTOOK, JR., Oklahoma 

PETER T. KING, New York 

JOHN LINDER, Georgia 

JOHN B. SHADEGG, Arizona 

MARK E. SOUDER, Indiana 

MAC THORNBERRY, Texas 

JIM GIBBONS, Nevada 

KAY GRANGER, Texas 

PETE SESSIONS, Texas 

JOHN E. SWEENEY, New York 

JIM TURNER, Texas, Ranking Member 

BENNIE G. THOMPSON, Mississippi 

LORETTA SANCHEZ, California 

EDWARD J. MARKEY, Massachusetts 

NORMAN D. DICKS, Washington 

BARNEY FRANK, Massachusetts 

JANE HARMAN, California 

BENJAMIN L. CARDIN, Maryland 

LOUISE MCINTOSH SLAUGHTER, New York 

PETER A. DEFAZIO, Oregon 

NITA M. LOWEY, New York 

ROBERT E. ANDREWS, New Jersey 

ELEANOR HOLMES NORTON, District of 

Columbia 

ZOE LOFGREN, California 

KAREN MCCARTHY, Missouri 

SHEILA JACKSON-LEE, Texas 

BILL PASCRELL, JR., North Carolina 

DONNA M. CHRISTENSEN, U.S. Virgin Islands 

BOB ETHERIDGE, North Carolina 

KEN LUCAS, Kentucky 

JAMES R. LANGEVIN, Rhode Island 

KENDRICK B. MEEK, Florida

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) 
(III)

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
Page

IV

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
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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 dramati-
2

cally 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. 
3

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 
4

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 
5

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. 
6

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-
7

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 sig-
8

nificant 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.
9

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. . 
10

• 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 
11

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.
12

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 
13

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. 
14

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 
15

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. 
16

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 
17

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. 
18

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 
19

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 re-
20

search 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. 
21

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 net-
22

works 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 
23

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 
24

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-to5 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 acquisition 

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? 
25

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 
26

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 fis-
27

cal 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. 
28

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—. 
29

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 
30

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 
31

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? 
32

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. 
33

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 bio-
34

defense 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 
35

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 to 

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. 
36

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. 
37

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 
38

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 JohnsonWinegar. 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 bioterrorismone aspect of the broader threat of weapons of mass destruction (WMD).
39

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 firststep 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.
40

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; longterm 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 
41

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 
42

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 
43

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 
44

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. 
45

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. 

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 interagency 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 longoverdue 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. 
46

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? 
47

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. 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. 
48

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 answer 

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 this 

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 
49

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 
50

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 
51

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, 
52

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 
53

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 
54

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 
55

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. 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 
56

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.] 
(57)

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? 
58

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 sciencebased 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. 
59

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, bio-
60

logical, 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 Councilled 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 tech-
61

nology, 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 pro-
62

gram 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 
63

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.
64

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 anti-
65

dotes.’’ 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 
66

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 com-
67

mitment 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 
68

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 PhDlevel 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. 
69

• 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, ade-
70

quate 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 
71

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

State 

CDC FISCAL YEAR 

2003

Emergency Preparedness

Funds 

Dollar Amount of

Cut to State 

Percent Cut

From FISCAL 

YEAR

2003 Funds 

Redirected $ for Cities

Readiness Initiative TFAH BT

Preparedness

Score, Scale 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 Angeles 2,670,000 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 

to DC 

DC 830,000 3

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
72

HHS Reallocation of $59.4 million in State Emergency Preparedness Funds for FISCAL 

YEAR 2004—Continued

State 

CDC FISCAL YEAR 

2003

Emergency Preparedness

Funds 

Dollar Amount of

Cut to State 

Percent Cut

From FISCAL 

YEAR

2003 Funds 

Redirected $ for Cities

Readiness Initiative TFAH BT

Preparedness

Score, Scale of

1–10**

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 Vegas 790,000 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
73

HHS Reallocation of $59.4 million in State Emergency Preparedness Funds for FISCAL 

YEAR 2004—Continued

State 

CDC FISCAL YEAR 

2003

Emergency Preparedness

Funds 

Dollar Amount of

Cut to State 

Percent Cut

From FISCAL 

YEAR

2003 Funds 

Redirected $ for Cities

Readiness Initiative TFAH BT

Preparedness

Score, Scale of

1–10**

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.
74

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 aero-
75

solized 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 
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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, nonspecific 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 
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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). . 
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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 backup 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 
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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) 
80

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?
81

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.

Æ