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BIOSHIELD: LESSONS FROM CURRENT EFFORTS

TO DEVELOP BIO-WARFARE COUNTERMEASURES

HEARING

BEFORE THE

SELECT COMMITTEE ON HOMELAND 

SECURITY 

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

FIRST SESSION

JUNE 6, 2003

Serial No. 108–9

Printed for the use of the Select Committee on Homeland Security

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/house
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., New Jersey 

DONNA M. CHRISTENSEN, 

U.S. Virgin Islands 

BOB ETHERIDGE, North Carolina 

CHARLES GONZALEZ, Texas 

KEN LUCAS, Kentucky 

JAMES R. LANGEVIN, Rhode Island 

KENDRICK B. MEEK, Florida 

JOHN GANNON, Chief of Staff 

UTTAM DHILLON, Chief Counsel and Deputy Staff Director 

STEVEN CASH, Democrat Staff Director 

MICHAEL S. TWINCHEK, Chief Clerk

(II) 
(III)

C O N T E N T S 

Page 

STATEMENTS 

The Honorable Christopher Cox, Chairman, Select Committee on Homeland 

Security, and a Representative in Congress From the State of California ..... 1

The Honorable Jim Turner, Ranking Member, Select Committee on Homeland 

Security, and a Representative in Congress From the State of Texas ............ 2

The Honorable Robert E. Andrews, a Representative in Congress From the 

State of New Jersey ............................................................................................. 4

The Honorable Donna Christensen, a Delegate in Congress from the U.S. 

Virgin Islands ....................................................................................................... 10

The Honorable Jennifer Dunn, a Representative in Congress From the State 

of Washington ....................................................................................................... 3

The Honorable Bob Etheridge, a Representative in Congress From the State 

of North Carolina ................................................................................................. 8

The Honorable Barney Frank, a Representative in Congress From the State 

of Massachusetts .................................................................................................. 10

The Honorable Duncan Hunter, a Representative in Congress From the State 

of Massachusetts .................................................................................................. 4 

The Honorable Sheila Jackson-Lee, a Representative in Congress From the 

State of Texas 

Oral Statement ..................................................................................................... 6

Prepared Statement ............................................................................................. 7 

The Honorable James R. Langevin, a Representative in Congress From the 

State of Rhode Island 

Oral Statement ..................................................................................................... 9

Prepared Statement ............................................................................................. 11 

The Honorable John Linder, a Representative in Congress From the State 

of Rhode Island ..................................................................................................... 5

The Honorable Karen McCarthy, a Representative in Congress From the 

State of Missouri .................................................................................................. 5 

The Honorable Kendrick Meek, a Representative in Congress From the State 

of Florida ............................................................................................................... 9

The Honorable Pete Sessions, a Representative in Congress From the State 

of Texas ................................................................................................................. 5

WITNESSES 

Dr. Ali Khan, Chief Science Officer, Parasitic Diseases, National Center for 

Infectious Diseases, Center for Disease Control and Prevention, Department 

of Health and Human Services 

Oral Statement ..................................................................................................... 12

Prepared Statement ............................................................................................. 15 

Joseph M. Henderson, Associate Director for Terrorism Preparedness and 

Response, Center for Disease Control and Prevention, Department of 

Health and Human Services ............................................................................... 23

Dr. John Ring LaMontagne, Deputy Director, National Institute of Allergy 

and Infectious Diseases, National Institutes of Health, Department of 

Health and Human Services 

Oral Statement ..................................................................................................... 17

Prepared Statement ............................................................................................. 19 
Page

IV

APPENDIX 

MATERIALS SUBMITTED FOR THE RECORD

Questions for the Record—for National Institute of Allergy and Infectious 

Diseases (NIAID) .................................................................................................. 62
(1)

BIOSHIELD: LESSONS FROM CURRENT EFFORTS TO DEVELOP BIO-WARFARE COUNTERMEASURES 

FRIDAY, JUNE 6, 2003

U.S. HOUSE OF REPRESENTATIVES, 

SELECT COMMITTEE ON HOMELAND SECURITY, 

Washington, D.C. 

The committee met, pursuant to call, at 10:06 a.m., in Room 345, 

Cannon House Office Building, Hon. Christopher Cox [chairman of 

the committee] presiding. 

Present: Representatives Cox, Dunn, Hunter, Sessions, Turner, 

Frank, Slaughter, Andrews, McCarthy, Jackson-Lee, Christensen, 

Etheridge, Langevin, and Meek. 

Chairman COX. Good morning. A quorum being possibly present, 

the Select Committee on Homeland Security will come to order. 

The committee is meeting today to hear further testimony relating 

to Project BioShield. I would like to welcome the members in attendance this morning and thank our witnesses for agreeing to appear before this committee on such short notice. This initiative is 

moving quickly. I am grateful to be able to hear your testimony before we mark up the legislation next week. 

The Secretary of Homeland Security is given a very important 

role in Project BioShield. This role is primarily one of threat assessment. Legislation requires the Secretary to assess existing and 

potential threats from chemical, biological, radiological and nuclear 

agents and to determine which of those threats presents a material 

threat against the United States population. 

Countermeasures to agents so identified by the Secretary will be 

eligible for purchase for the strategic national stockpile using BioShield’s special funding mechanism. 

The Department’s pivotal responsibilities under BioShield are 

part and parcel of its broader threat assessment responsibilities 

under the Homeland Security Act. There is a virtually infinite universe of potential threats, of course only a finite amount of resources to deal with them. 

Conducting the kind of analysis and assessment that will allow 

us to set security priorities and focus our efforts on the most pressing threats is one of the most important functions of the Department of Homeland Security. Quality threat assessment is absolutely critical in order to prevent attacks on our homeland. This is 

nowhere more true than in the case of bioterrorism. To best protect 

against attacks on the U.S. population, our efforts must be con-
2

centrated fully on the agents that pose the greatest danger. Assuring this is the Department of Homeland Security’s responsibility. 

Yesterday, the Subcommittees on Emergency Preparedness and 

Response and Intelligence held a joint hearing examining the infrastructure already in place and the infrastructure that is now being 

built at DHS for performing the threat assessment required for the 

success of BioShield. 

I want to thank Chairmen Shadegg and Gibbons for holding that 

hearing. This hearing is intended to bring the benefit of the valuable experience of other existing biothreat programs to our discussion of BioShield and the role of DHS. This hearing will help us 

understand the challenges the Department of Homeland Security 

will face and the capabilities that it must develop. 

We have witnesses with us from the National Institutes of 

Health and the Center for Disease Control, both within the Department of Health and Human Services. HHS already performs threat 

assessment that is closely related to the kind of analysis that DHS 

will be required to perform for the BioShield legislation. The Secretary of Health and Human Services is required by the Bioterrorism Preparedness Act of 2002 to maintain a list of agents and 

toxins that could potentially pose a severe threat to the public 

health. This list is then used to set research and response priorities 

within the Federal Government 

In order to be successful, DHS must perform these assessments 

and more. The Secretary must be able to combine a determination 

of which agents are most intrinsically dangerous with an intelligence assessment of terrorist capabilities. I hope this hearing 

gives us an idea of what this entails and whether there is anything 

that we in Congress must do as we consider this legislation to help 

the Department fully meet its mandate. 

I look forward to hearing from our witnesses. 

The Chair would now recognize the ranking member, Mr. Turner, for his opening statement. 

Mr. TURNER. Thank you, Mr. Chairman. I want to thank you for 

your leadership on this issue of the biological threat that we face 

as a nation. I appreciate that this committee has been aggressive 

in trying to schedule hearings on this important piece of legislation 

and attempting to delve into some of the tougher issues that we all 

know exist. 

Our hearing yesterday revealed to us information that I think all 

of us on both sides of the aisle consider to be quite disturbing with 

regard to the progress of the Department of Homeland Security, 

and its ability to carry out the responsibilities that we will be giving it under the BioShield legislation. And I am hopeful that we 

can move forward in urging the President and the Secretary of the 

Department to further strengthen that portion of the Department’s 

function and responsibility. 

Our hearings on Project BioShield have demonstrated, I think to 

all of us, that to solve the problem of bioterrorism, we are going 

to have to form a strong relationship between the public and the 

private sectors. The BioShield legislation is designed to give our 

pharmaceutical industry incentives to do what they do best, and 

that is, to take a potential medicine or vaccine against a biological 

agent and bring it to the stage where it can be mass produced. 
3

But the difficult work of basic research and drug development is 

being done elsewhere. It is being done in government research laboratories, in the biotech industry and in our research universities. 

The seriousness of the bioterrorism threat and the sophistication 

required to develop adequate defenses requires, in my view, a sustained long-term and extremely focused research and development 

effort. We simply cannot leave this responsibility to the uncertainties of the market and sit back and hope that all the drugs and 

vaccines will be developed. 

The federal government must play a role in funding the basic research and development work needed for an adequate biodefense. 

The administration has recognized this as well. That is why the 

proposed funding for biodefense at the National Institute for Allergies and Infectious Diseases has risen from $180 million since September 11th to the proposed $1.6 billion in next year’s budget, an 

800 percent increase. This funding increase is dramatic, and I 

wholeheartedly support it. 

Still, the task of developing countermeasures is so difficult and 

so vitally important, there are many other issues besides the 

amount of resources that need to be addressed. First, the National 

Institute for Allergy and Infectious Diseases, commonly referred to 

as NIAID, has traditionally focused, as I understand it, on pure scientific research. Now it is being asked to become more involved in 

a related but distinct task of drug development. I will be interested 

to learn from our witness today what the leadership of NIAID is 

doing to implement this change of culture within your own organization, and I hope to hear assurances that we are making the proper investments to ensure that we get not only good research but 

also countermeasures that we can use to protect the American people. 

Secondly, we have heard extensive testimony about the effectiveness of Project BioShield. There is a distinct possibility that the 

private sector may not participate in bringing promising drugs 

from the development stage toward final production, and I would 

like to know from our witnesses whether the government has or 

could build that capacity in the event the incentives in the BioShield legislation are insufficient. 

I am particularly interested to learn more about NIAID’s Vaccine 

Research Center as it relates to the biodefense effort. I am pleased 

that we have excellent witnesses from both the NIAID and CDC 

here today. You have a very important job to do. We want to support you in it, and be sure that you are successful. 

I thank you, Mr. Chairman. I look forward to hearing from both 

of our witnesses. 

Chairman COX. Thank you. 

The Chair recognizes the vice chairman of the full committee, the 

gentlelady from Washington, Ms. Dunn, for her opening statement. 

Ms. DUNN. Thank you, Mr. Chairman, and welcome, gentlemen. 

Thank you for being here with us today. As members of this committee will agree, the downside of serving on a brand new committee is that we don’t have a space to call our own. This is just 

a temporary problem. We will find a space of our own very soon, 

but I am very happy that you were able to join us here in the Cannon Caucus Room today. 
4

Providing the Department of Homeland Security the necessary 

resources to protect Americans from biological attacks is a very important goal for this committee, and I look forward to your input 

on implementing the BioShield Project. 

As we found during the anthrax attacks in the fall of 2001, very 

small amounts of biological agents can wreck havoc on our livelihood, affecting our work, our home and the Nation’s economy. All 

of us in Congress were affected by the discovery of anthrax in office 

buildings in the House and the Senate. As we will recall, all staff 

were exposed—there were some staff who opened the mail who 

were, in fact, exposed to anthrax, and we experienced and continue 

to experience today delays in receiving our mail, and of course 

many of our offices were quarantined during those days. 

With the havoc the anthrax attacks caused, we all learned that 

we will need to be better prepared if a biological attack occurs to 

a greater population. Project BioShield will be a very important 

part of our homeland security efforts, yet its successes will not be 

dependent solely on how much money we are able, as Members of 

the Congress, to provide, but on developing the coordination, the 

infrastructure and the leadership within DHS and among other 

Federal agencies and our public health system. 

Today we will hear about the role of the Centers for Disease Control and the National Center for Infectious Diseases in helping to 

prevent and respond to potential bioterrorism attacks. I look forward to hear how the CDC and the NIH will work together to ensure the safety of the American people. 

BioShield, if implemented successfully, will have a profound effect on mitigating the effects of a biological attack as we are preparing to mark up this legislation toward the end of next week, I, 

too, look forward to hearing from you and to gleaning something 

from your experience today. 

Thank you, Mr. Chairman. 

Chairman COX. Thank you. The gentleman from the great State 

of New Jersey, whose Devils were successful last evening, Mr. Andrews, is recognized for his opening statement. 

Mr. ANDREWS. Thank you, Mr. Chairman. I look forward to the 

testimony of the witnesses, and—the specific time measurements—

and what I want to do on behalf of my constituents is know what 

benchmarks I should be evaluating. I am quite satisfied that you 

have laid the initial groundwork that you ought to lay, and I commend you for it. What I am interested in is learning ways that we 

can measure your progress in this very important mission. Thank 

you, Mr. Chairman. 

Chairman COX. The gentleman from California, the chairman of 

the Committee on Armed Services, Mr. Hunter, is recognized for 

his opening statement. 

Mr. HUNTER. Well, thank you, Mr. Chairman, and likewise I 

don’t have a lengthy opening statement, but I want to thank my 

colleagues. Thank you and Mr. Turner and all my colleagues for 

the hearing, and simply say that in the end, we are going to have 

to translate these disparate agencies and all of the players in what 

I would call this maybe three-part chain, that is, detection, analysis 

and protection, into an apparatus that can move very quickly, 

meaning that if there is a disease or a substance that is threat-
5

ening, whether it is troops in theatre or civilians in this country, 

a single team that can move quickly to capture some of that substance or that disease, move it quickly to an analytical team, and 

from there, take it quickly to a team that can put together a defensive measure and then apply that, whether it—it has to be applied 

in inoculation to the civilian population or to the uniform services, 

and sometimes in this country, resolving fragmented and disparate 

agencies into a focused effort that involves action, and in this case, 

I think it is going to have to be action that can take place very rapidly is sometimes one of our biggest challenges. 

So I am interested in knowing how we are going to put that team 

together, and how it is going to be integrated with the efforts that 

are already ongoing. 

Obviously in the military, we have as the operation in Iraq has 

reflected, the capability of analyzing some of the obvious challenges 

and dangers and taking action to prevent those from becoming 

damaging to our troops, and so we have the—at least the embryonic apparatus of a BioShield in place with respect to the military 

already, but I am interested in knowing how we are going to be 

able to make this thing work together, the domestic and the military elements, and bring them—meld them into a single apparatus 

that can get the job done. So thanks for the hearing, and gentlemen, thanks for being with us 

Chairman COX. The gentlelady from Missouri is recognized for 

her opening statement. Ms. McCarthy is recognized for 5 minutes. 

Ms. MCCARTHY. Thank you, Mr. Chairman. My mike is having 

problems. I thank you for calling this meeting. I don’t think—. 

Chairman COX. If the gentlelady would suspend, it occurs to me 

that because we have so much space up here behind the dais, that 

if members would like to relocate, they would be welcome to do so, 

but at least you might want to relocate to a microphone that works. 

Ms. MCCARTHY. Thank you very much, Mr. Chairman. I don’t 

know of an issue more critical, more timely or more important than 

the biodefense of our country, and I am so grateful to you for calling this hearing. And ranking member Turner, thank you as well. 

And Dr. Khan and Dr. LaMontagne, I look forward very much to 

your input, and I know you look forward to our questioning and our 

thoughts as well as we work together as a team to address this 

very vital issue. 

Thank you very much. I would yield back my time, and I look 

forward to continuing the hearing. 

Chairman COX. The gentleman from Georgia wishes to waive his 

opening statement? 

Mr. LINDER. I have no comment, Mr. Chairman. 

Chairman COX. The gentleman from Texas is recognized for an 

opening statement. 

Mr. SESSIONS. Thank you, Mr. Chairman. Dr. Khan, Dr. 

LaMontagne, we appreciate you being here before this committee 

today. I am particularly interested in your comments as they relate 

to the legislation that deals with the ability to take from what I 

would say in the lab ideas and serums or answers to problems and 

bringing them directly out on an expedited basis. 

Now more than ever, this country and this world is faced with 

new viruses, new problems, new plagues that confront us, and I 
6

don’t know that it is necessarily bioterrorism, but it is certainly 

things that emanate as a result of people and animals and things 

all around the world. And so in particular, I would look today to 

hear from you about how we take those things as they are identified in the world as problems, threats to civilization, how we can 

mature that process very quickly in the laboratory and then make 

them generally available to people, and generally speaking, our 

process has been, I believe, slow. While I am satisfied that our 

pharmaceutical community does a very good job, I am concerned 

about rules and regulations that inhibit the introduction of those 

drugs on a more widely available and quicker basis. 

So I will look forward to that testimony and hearing that from 

you today, and want to thank both of you for being before this 

great Select Committee today. I yield back, chairman. 

Chairman COX. Thank you. The gentlelady from Texas, Ms. Jackson-Lee, is recognized for an opening statement. 

Ms. JACKSON-LEE. Thank you very much, Mr. Chairman and the 

ranking member, for holding a very important hearing this morning, and I am pleased to join my colleagues on this committee. I 

would ask, Mr. Chairman, unanimous consent that my entire statement be allowed to be submitted into the record in it entirety. 

Chairman COX. Without objection, and the chairman would note 

that all members will have the opportunity to submit further opening statements for the record. 

Ms. JACKSON-LEE. Before their testimony even, I would like to 

thank the witnesses and just to make note that for a moment I 

have to testify in the Senate for a moment, but I will look forward 

to reviewing, as I have, their statements and look forward to participating in the questions. 

We realize that terrorism is alive and well. In light of the tragic 

incidents in Riyadh, Saudi Arabia on May 12th, and of course, the 

tragedy in Morocco where 43 people were killed, it makes this 

hearing even more important, because we realize that the threat of 

bioterrorism remains with us, and the fact that biological weapons 

are highly portable and difficult to detect. Positive strides have 

been made in securing our borders and presenting unwanted materials from entering our country, but it is unrealistic to expect no 

biological weapons to enter the United States or maybe even to be 

created here. 

Last year alone, 30 million tons of cocaine was smuggled into the 

United States. If we can’t stop 30 million tons of cocaine, then we 

know the difficult charities, if you will, of dealing with the issue 

of bioweapons. Your position here or your testimony here will be 

helpful to us and insightful and encouraging as to how we might 

further enhance the security of America. 

We are trying to educate our citizens with the color system. I believe now more and more they are sensitive to the fact that when 

we make note of the various levels of threat, that they will pay attention, but look, for example, to the worldwide SARS outbreak. 

No, it is not a biological terrorist effort, but we do know it has been 

difficult to deal with. The inability of many foreign countries to 

adequately deal with that outbreak raises questions about our own 

preparedness. What about other infectious diseases, like tuberculosis? Just last summer the country was faced with the West 
7

Nile virus. Of course, that was not a biological threat or terrorist 

act, but I can tell you in my community, we faced real challenges 

in educating the community about how to protect themselves. 

We must do better in the area of biological weapons and the 

threat that they pose. 

The ease with which biological weapons can be manufactured is 

also a danger. The equipment and ingredients needed to manufacture many biological agents can be purchased over the Internet. 

Additionally, as our failure to apprehend those responsible for the 

2001 anthrax attacks illustrates, biological terrorists can operate 

with more secrecy than traditional terrorists. We must be concerned. The provisions of Project BioShield provide a good start to 

protecting Americans from bioterrorist attack, but work remains. 

It is important, of course, to realize the provisions in this legislation grants the National Institute of Health new powers, good powers through grants and contract awards to speed effective research 

and development efforts on bioterrorism countermeasures. I am interested in making sure that all of America, all of America’s research specialists, all of America’s universities, Hispanic serving 

universities, historically black universities, small universities and 

colleges understand this process so that those who have capacities, 

no matter where they are, will reach out and participate in the research and grant efforts. 

In addition, I might want to raise a question, as I close, about 

the 40 million uninsured Americans who do not have health care. 

They do not have established relationships with physicians. How 

do we get them in the line of prevention, immunization? How do 

we work with some of the failures of this Nation so that we can 

ensure that every single person within our boundaries remains safe 

and secure as we fight collectively the war against terrorism. I am 

delighted that this hearing is proceeding, and I know that we will 

have good instructions that we should. And I yield back, Mr. Chairman. 

[The information follows:]

PREPARED STATEMENT OF THE HONORABLE SHEILA JACKSON LEE, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. Chairman and Mr. Ranking Member, I thank you for convening this vital 

hearing to hear testimony from government experts on their efforts to assess the 

bioterror threat, develop countermeasure to bioterror attacks, and coordinate with 

Project BioShield. 

The Al Qaeda terrorist network remains a threat to Americans and peaceful people worldwide. The recent suicide bombing attacks have confirmed that terrorist 

cells are still planning and executing deadly attacks. In Riyadh, Saudi Arabia, on 

May 12th, nine suicide bombers attacked three residential compounds. The attacks 

took the lives of 35 innocent people including 9 Americans. Another suicide bombing 

attack in Morocco killed 43 people. Despite Homeland Security Department Secretary Tom Ridge’s decision to lower the terrorism threat on May 30th, American’s 

are still at risk. Our nation’s elevated level of vigilance may protect us from attacks 

like suicide bombing, but there are many other terrorist threats that put American 

lives at risk. Bioterror attacks are a perfect example. 

The threat of bioterrorism must be one of our chief concerns as we continue our 

work of protecting our homelands from terrorist attacks. Biological weapons pose a 

particularly dangerous threat. Biological weapons are highly portable and difficult 

to detect. Positive strides have been made in securing our borders and preventing 

unwanted materials from entering our country, but it is unrealistic to expect no biological weapons to enter the United States. Last year alone 30 million tons of cocaine was smuggled into the United States. If we can’t stop 30 million tons of co-
8

caine from crossing our borders, how can we expect to stop a vile filled with anthrax, botulism, or small pox? A vile that could kill hundreds or possibly thousands. 

Bioterrorism attacks not only pose a danger to human lives, they also have the 

ability to cripple the operation of our society and severely harm our economy. We 

all recall the primary and secondary impact of the anthrax attacks in 2001. The attacks involved a series of letters mailed in pre-stamped envelopes to media outlets 

in Florida and New York and to the offices of Senators Thomas Daschle and Patrick 

J. Leahy (D–Vt.). The anthrax attacks killed five Americans and left 13 others severely ill. The five people who died from inhalation anthrax included two postal 

workers at the Brentwood postal facility in Washington, a Florida photojournalist, 

a New York hospital worker and a 94-year-old woman in Connecticut. Thousands 

more were exposed to the lethal bacteria. The letters passed through various post 

offices and postal distribution centers along the East Coast leaving a trail of contamination. Buildings from the Brentwood mail facility, to the Congressional office 

buildings, to NBC headquarters had to cease operations. 

The threat of bioterrorism did not end in September of 2001. As recently as April 

22nd of this year in Tacoma, Washington we had a bioterrorism scare. A white powder was found in two envelopes, and 94 people had to be evacuated from a mail distribution facility. Initial tests of the powder tested positive for biotoxins that cause 

bubonic plague or botulism. Four people at the facility had to be decontaminated. 

The same day, a suspicious powder was found in a Federal Express cargo area at 

Southwest Florida International Airport, in Fort Myers, Florida. Six people were 

taken to a hospital for possible decontamination, including one who suffered burning 

eyes and nose. 

We are presently faced with the threat of a worldwide SARS outbreak. The inability of many foreign countries to adequately deal with that outbreak raises questions 

about our own preparedness. What about other infectious diseases like tuberculosis? 

There are many ailments that our medical professionals are struggling to control. 

We must do better in the area of biological weapons. 

The ease with which biological weapons can be manufactured is also a danger. 

The equipment and ingredients needed to manufacture many biological agents can 

be purchased over the Internet. Additionally, as our failure to apprehend those responsible for the 2001 anthrax attacks illustrates, biological terrorists can operate 

with more secrecy than traditional terrorists. 

These are but a few concerns we face as we consider Project BioShield. The provisions of Project BioShield provide a good start to protecting Americans from a bioterrorist attack but work remains. Presently Project BioShield’s provisions grant the 

National Institute of Health new powers, through grants and contract awards, to 

speed effective research and development efforts on bioterrorism countermeasures. 

Project BioShield also creates a long-term funding mechanism for the development 

of medical counter measures, and empowers the government to purchase safe and 

effective vaccines. Finally, Project BioShield authorizes the Food and Drug Administration to use promising, yet uncertified, biological treatments in the case of emergencies. 

Mr. Chairman and Ranking Member, I believe these are good first steps in protecting Americans from biological attacks. However, I feel that many questions remain. I look forward to the testimony of our witnesses today, and I hope that their 

guidance can help us make all Americans less vulnerable to bioterrorism.

Chairman COX. I thank the gentlelady. The gentleman from 

North Carolina, Mr. Etheridge, is recognized for purposes of an 

opening statement. 

Mr. ETHERIDGE. Thank you, Mr. Chairman. Thank you for holding this hearing. I am going to be rather brief, but I do want to 

say based on the hearings we held yesterday and the information 

concerning—or the lack thereof, of information as it relates to biochemical weapons and others, I am somewhat disturbed, so I hope 

this morning you can—even though this is not part of your testimony, that your information will be more inclusive and helpful, because I think from what I heard yesterday, I am quite aware and 

concerned that the level of threat may be higher than we even 

think. 

But I hope you will discuss or share with us, even though the 

responsibility is on a broader scope—you know, most people live in 
9

local communities, you know, and the concern is what about the 

local community. Local health departments for a lot of people is 

where they receive their services. Depending on where you are in 

the United States, if you are in a rural area, that those departments are absolutely overloaded. We have people who aren’t even 

taking smallpox shots now to be able to provide services if something should happen. 

So I hope you will share some of that with us this morning and 

talk about two very critical issues to local folks. That is, the safety 

of water and the food. We have the safest food supply in the world, 

but I can see if there is an area where you would want to have 

some problems, you could create turmoil very quickly there. And I 

think that is important and as we look at the global movement of 

people. It may be, as has already been stated this morning, something someone intentionally puts in a system. It may be something 

that is started in nature that moves because we move so quickly 

from one part of the world to the other. Historically, you have dealt 

with those issues in a very positive way, and I would congratulate 

you on it, but I think as we look out into the 21st century, those 

challenges are going to increase even more. So I hope you will 

touch on that this morning. 

Thank you, Mr. Chairman. 

Chairman COX. Thank you. The gentleman from Rhode Island, 

Mr. Langevin, is recognized for his opening statement. 

Mr. LANGEVIN. Thank you, Mr. Chairman, and I too will have a 

more formal statement to submit for the record, but, Mr. Chairman, I want to thank you and the ranking member for organizing 

this hearing, and I would like to thank the gentlemen for their 

presence and look forward to their testimony today. 

I noticed in my briefing memo that we had attempted to get witnesses from DOD and DHS but were unable to do so. I would hope 

that DOD and DHS would follow the lead of CDC and NIH in 

being more forthcoming with this committee in the future. 

The areas that I hope the gentleman will address and things that 

I am concerned with—and I agree with the gentlelady from Missouri that the bioterror threats that are facing this country are significant, and there is no greater a priority we should have than addressing and dealing with these issues. 

I will be most concerned with knowing if you have adequate resources to do the job that you are facing. I would also be interested 

in hearing the degree to which you are coordinating efforts, both 

with nongovernmental and governmental agencies, particularly 

DOD and DHS, and also I am interested in knowing how you are 

setting priorities in terms of what types of bioterror threats we 

need to address, both terrorist threats or natural emerging pathogens that are antibiotic and drug resistent. But I thank you for 

your presence today and look forward to your testimony. Thank 

you, Mr. Chairman. 

Chairman COX. Thank the gentleman. The gentleman from Florida, Mr. Meek, is recognized for an opening statement. 

Mr. MEEK. Thank you, Mr. Chairman, and I would like to not 

only welcome our witnesses, but also thank the leaders in this committee, including yourself, for having this very important hearing. 

You heard some reference to yesterday. You had nothing to do with 
10

yesterday. Today is today, and I am glad that you are here, and 

I am more interested in understanding more about our potential 

threat level and how y’all have worked with other agencies, both 

of your agencies work with other agencies to—the agencies abroad 

of efforts that they have to fight against as it relates to bioterrorism, will we be the leader in this effort, or are there other countries that are—taking countermeasures against bioterrorism? 

What we are asked in this proposed legislation when we start to 

mark it up is to relax acquisition procedures, and we are going to 

be asked to do many things that we are not doing now, to give 

great discretion to members of the administration and future members of future administrations to be able to protect Americans in 

the future. I think that is so very, very important. We deal with 

bioterrorism from my reading and from what I have been briefed 

about, and something is going to be very difficult—I don’t know if 

we can legislate the countermeasures totally, so what you do in the 

research community is going to be vital. 

Intelligence will be vital also, and I know that, Mr. Chairman, 

as we go through this process, that we will discuss and iron out 

many of those issues, but I know that in this particular area, that 

preventive maintenance through discussion and also allowing many 

people within the field of helping us find countermeasures towards 

bioterrorism is going to be important. So I look forward to the discourse, and I want to thank both of you for being here this morning. 

Chairman COX. I thank the gentleman. 

The gentlelady from the Virgin Islands is recognized for an opening statement, Mrs. Christensen. 

Mrs. CHRISTENSEN. I will submit my opening statement for the 

record, Mr. Chairman, and do we get 8 minutes if we don’t do an 

opening statement? 

Chairman COX. Yes. In fact, I think the Chair will be able to be 

very liberal today because of the good attendance of those who are 

here. 

Does any other member wish to make an opening statement? 

The gentleman from Massachusetts, Mr. Frank, is recognized for 

an opening statement. 

Mr. FRANK. Thank you, Mr. Chairman. To begin, I want to thank 

you for the role the committee has been playing recently. I think 

yesterday’s hearing, although painful was very useful, and this is 

exactly the role we should be playing and I am pleased to be part 

of it. 

On this issue as I read Dr. Khan’s statement, I was struck by 

his appropriate reference on several occasions to the role of State 

and local government, and we should be clear here. The role of the 

Federal Government in this situation is to direct the research to an 

overall coordinator, but the delivery of the service, whatever it is 

in terms of dealing with bioterrorism, is going to be overwhelmingly State and local. We don’t have a core of Federal officials that 

we are going to dispatch. 

And this is what troubles me about our current situation. While 

we are appropriately building up at the Federal level our capacity 

to deal with terrorism at that level, we are seeing an erosion at the 

State and local level of our capacity to carry out these policies. The 
11

fact is that there are not two separate public health systems and 

two separate police departments and two separate fire departments, one of which at the State and local level exists to deal with 

terrorism outbreaks and another of which just exists to deal with 

ongoing activities, and what we have got, because of the fiscal policies being followed at the Federal and State level, is a serious erosion in many cases of the capacity of the State and local public 

safety people, public health, police, fire and others, to respond. And 

we are building up this structure at the same time that we are seeing the base weaken, and I do not think that it is a very sensible 

policy. 

So I think it is important for us to go ahead with these preparations at the national level, but it is a mistake to think that we can 

do this. And as I said—read Dr. Khan’s statement, he talks appropriately about working with State and local agencies. The actual 

execution of many of these plans is going to have to be carried out 

by local people, and as I said before, we were asked during anthrax 

whether the American public health system was ready for an outbreak of bioterrorism, and I can tell you from what I know of the 

cities, the American public health system isn’t ready for Friday 

night. 

I mean, by midnight tonight in many American cities, the emergency rooms are going to be closed. So to think we can then expect 

them in an emergency to take advantage of all this work that we 

hope we are going to be able to do is a mistake, and so I just urge 

that we treat—keeping the local public health, the local hospitals, 

the police, the fire and other responders in emergencies, keeping 

them in good shape overall is as important to this fight against any 

potential terrorism outbreak than anything else. 

Chairman COX. I thank the gentleman. 

Does the gentlelady from New York wish to make an opening 

statement? 

Ms. SLAUGHTER. Thank you, Mr. Chairman. In the interest of 

time, I will withhold. I do have some questions, however, at the 

proper time. Thank you. 

Chairman COX. Does any member wish to make a further opening statement?

PREPARED STATEMENT OF THE HONORABLE JIM LANGEVIN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF RHODE ISLAND 

Thank you, Mr. Chairman. I would like to welcome our two witnesses, Dr. 

LaMontagne and Dr. Khan, for what I expect will be a very informative and productive hearing. I appreciate your willingness to come before us. I would also like to 

note that it is my understanding that the Committee sought witnesses from the Departments of Defense and Homeland Security to join you today, but none were forthcoming. It is my sincere hope that in the future, these agencies will show the same 

willingness as CDC and NIH to make their representatives available for participation in these important hearings. 

Mr. Chairman, bioterrorism represents a major threat to our national security, 

and I believe it is our job as members of this Select Committee to instill confidence 

in the American people that a coordinated, concerted effort is being made to combat 

bioterror. Unfortunately, I do not think we have reached that point yet, but I do 

think that hearings like today’ are important steps towards that goal. 

I’ very interested to hear from our witnesses about whether the resources they 

have are sufficient to handle the significant tasks for which they are responsible. 

In addition, I hope to learn what, if any, coordination exists between health-focused 

entities like CDC and NIH, and the Department of Homeland Security and Depart-
12

ment of Defense in identifying threats and directing efforts appropriately to address 

the most pressing dangers we face. 

Specifically, I will be looking forward to hearing about what kind of formal procedures exist for information-sharing between members of the intelligence community 

and our federal medical researchers. If there is currently no formalized process, I 

would be interested to hear whether our witnesses think such a process would be 

helpful in determining where and how to direct their efforts, and how we on the 

Committee might be helpful in creating such a relationship. 

I would also like to know whether our experts in the medical and public health 

areas of bioterror are working with peers in the intelligence community to determine threats and prioritize activities, or whether the intelligence agencies lack analysts with the appropriate medical expertise. Finally, I am interested in knowing 

whether DHS has sought the input of agencies like CDC and NIH as they set up 

their system for intelligence analysis of bioterror threats. 

Again, Dr. Khan and Dr. LaMontagne, I greatly appreciate your presence here 

today. This is a vital issue, and I look forward to hearing from you both.

If not, I would like again to welcome our witnesses. We have two 

witnesses with us this morning, Dr. John Ring LaMontagne is the 

Deputy Director of the National Institute of Allergy and Infectious 

Diseases. And Dr. Ali Khan is the Chief Science Officer for parasitic diseases at the National Center for Infectious Diseases in the 

Center for Disease Control and Prevention. 

Chairman COX. We have both of your written statements, and 

appreciate your submitting them. You are welcome to summarize 

and expand upon those statements in the 5 minutes that are dedicated to your formal testimony before we proceed to questions. I 

would like to begin, Dr. Khan, with you.

STATEMENT OF DR. ALI KHAN, CHIEF SCIENCE OFFICER, 

PARASITIC DISEASES, NATIONAL CENTER FOR INFECTIOUS 

DISEASES, CENTER FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Dr. KHAN. Good morning. Thank you.—se attention. 

Chairman COX. Dr. Khan, I wonder if you could pull that microphone closer to you. 

Dr. KHAN. Is that better? You have stated my current title. Let 

me start by saying that I was previously the scientific director for 

CDC’s initial bioterrorism program and helped craft the framework 

for our national preparedness activities, including formulating our 

critical agent list to facilitate coordinated planning. Biologic agents 

on this list remain the basis for our State and local public health 

preparedness programs, formulary decisions for the national strategic stockpile, and the diagnostic reagents we distribute through 

our laboratory response network. 

This list has also been—. 

Mr. FRANK. Excuse me, Mr. Chairman. This room makes it hard 

to hear anything other than a horse, so if you could pull the mike 

closer and speak louder, I would appreciate it 

Dr. KHAN. Is that better? 

Chairman COX. Yes. Much better. 

Dr. KHAN. The critical agent list has been embraced by the NIH 

for their research purposes and the medical community—. 

Mr. FRANK. I hate to be picky, but a little too much—. 

Dr. KHAN. I have been invited to discuss the process used to determine which biologic agents were selected for the list. However, 

let me state up front that my current activities center on global 
13

emerging infectious diseases and malaria prevention activities 

worldwide. 

However, I am joined by Mr. Joe Henderson, CDC’s associate director for Terrorism Preparedness and Emergency Response, sitting on my right. He is the gentleman who is currently responsible 

for our bioterrorism preparedness program and is available for 

questions the committee may have about our current program. 

I would like to go over two things briefly, first, how these certain 

biologic agents were selected and prioritized to make up the critical 

agent list and then the three categories of agents. In June of 1999, 

CDC convened a meeting of academic infectious disease experts, 

national, State and local public health authorities and civilian and 

military intelligence and law enforcement officials. They were 

asked to review and comment on the potential public health impact 

to civilian populations of various biologic agents. Four criteria were 

used to assess this public health impact. The first was the anticipated amount of illness and death do to an agent. The second was 

a delivery potential to a large population based on a combination 

of the stability of the agent, the ability to mass produce and distribute the agent and its potential for person-to-person spread. 

The third criteria was the public perception of the agent in terms 

of arousing public fear and causing civil disruption. And the fourth 

criteria was the special public health preparedness needs relating 

to detecting and responding to the deliberate dissemination of a 

biologic agent in our communities based on their surveillance requirements, their diagnostic tools, stockpile needs, preparedness 

needs. 

And these last two criteria are actually unique futures of the 

public health list, compared to many other lists that do occur for 

preparedness and other specific purposes. 

Now, the participants I just discussed, they identified these four 

criteria and reviewed previously identified biological warfare 

agents in light of these four criteria. Once that was done, CDC personnel identified objective indicators in each of these categories, 

used a risk matrix analysis process to go ahead and further 

prioritize all of these agents that were initially discussed. The overall rating process in these four areas was used to assign agents to 

Category A, B and C, based on the priority of public health preparedness that would be required, and essentially the public health 

impact of these agents. 

This risk matrix analysis in the final listing was subjected to an 

external peer review process and published for wide dissemination 

in the public health and medical communities. I believe all the 

members of the committee have a copy of that published paper that 

discussed the analysis and what agents eventually came out in that 

analysis. 

And I will quickly go through those three categories. Agents in 

Category A have the greatest potential for adverse public health 

impact with mass casualties and essentially require the most 

broad-based public health preparedness efforts, be they be in surveillance, laboratory diagnosis, and again for the stockpile needs 

for specific medications. These agents have the most risk of dissemination to a large group of people, generally small particle 

aerosols in the air, and are most likely to cause civil disruption. 
14

The diseases that these agents cause include smallpox, anthrax, 

plague, botulism, tularemia and some select biohemorrhagic fever 

such as Ebola hemorrhagic fever. 

Now, it is because of this list and the presence of the anthrax 

on this list that we had Cipro and Doxi available in the national 

pharmaceutical stockpile. We had diagnostic tests for anthrax at all 

the local and State health departments in October of 2001 during 

the anthrax attacks. So it was because of that process that these 

preparedness measures were in place. 

Now, the Category B agents have some potential for widespread 

dissemination, but do not pose the same threat potential or have 

the same degree of preparedness needs as Category A agents. 

Agents in this category required some focused improvements in 

surveillance and diagnostic, but generally the way these lists are 

structured, for the moment that you get to Category B, most of 

your stockpile and drug needs have already been met by Category 

A agents. So there is less need by the time you get to the second 

set of agents. And the agents on this list include brucellosis, typhus, various viruses that cause encephalitis and certain agents of 

concern for water and food safety issues, bioterrorism issues. 

In the category C agents are not currently believed to present the 

high bioterrorism risk to public health, but they could emerge as 

future threats. Threat of these agents will be addressed by our general bioterrorism preparededness efforts and the ongoing development that is necessary for the public health infrastructure for detecting and responding to new diseases of unknown etiology or new 

emerging infectious diseases. 

And the above category of agents should not be considered definitive. Agents in each category may change as we get new information or we obtain new assessment methods on how they may be 

used. However, fortunately, to date these lists—this list has not 

warranted being changed. 

To meet the ever-changing response in preparedness challenges 

presented by bioterrorism, a standardized and reproducible evaluation process similar to the one I just outlined to you and is described in much more detail in the paper and the written testimony 

will continue to be used to evaluate and prioritize the current 

agents on the list and new agents that may emerge as threats to 

our civilian population and our national health security. 

In conclusion, CDC is committed to working with other Federal 

agencies, academia and other partners, as well as State and local 

public health departments to ensure the health and medical care 

of our citizens. We have made substantial progress to date in enhancing the Nation’s capacity to prepare for and respond to a bioterrorism event. The best strategy, however, that remains to protect the health of our civilians against a biological attack is the development, organization, and enhancement of our public health 

prevention systems, tools and research. Not only will this approach 

ensure that we are prepared for deliberate bioterrorist threats, but 

will also ensure that we are able to recognize and control naturally 

occurring and reemerging diseases such as West Nile a couple 

years ago, SARS this year, and pandemic influenza when it will reoccur. 
15

A strong and flexible public health infrastructure is our best defense against any disease outbreak, and I believe many members 

have already mentioned this. Thank you very much for your attention. I will be happy to answer any questions you may have. 

[The statement of Dr. Khan follows:]

PREPARED STATEMENT OF DR. ALI S. KHAN 

Good morning, Mr. Chairman and Members of the Committee. I am Dr. Ali Khan, 

Associate Director for Medical Science, Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC). I am 

accompanied today by Mr. Joseph M. Henderson, CDC’s Associate Director of Terrorism Preparedness and Emergency Response. Thank you for the invitation to participate today in this hearing on the challenges and progress made in identifying 

agents that could be used as biological weapons. I will outline the overall selection 

and prioritization process used to determine the biological agents for CDC’s public 

health preparedness activities.

As part of a Congressional initiative begun in 1999 to upgrade national public 

health capabilities for response to acts of biological terrorism, CDC was designated 

the lead agency for overall public health planning. An Office of Terrorism Preparedness and Emergency Response has been formed to help provide strategic direction 

across CDC, targeting areas to enhance preparedness activities, planning, improved 

surveillance and epidemiologic capabilities, rapid laboratory diagnostics, communications, and the delivery of medical therapeutics stockpiling. To focus these preparedness efforts, however, the biological agents toward which the efforts should be 

targeted had to be first formally identified and prioritized according to the level of 

threat posed. These agents make up CDC’s critical agent list. This list is used as 

the framework for guidance to the state and local preparedness programs, determining the formulary for the Strategic National Stockpile, developing public health 

response plans and determining reagents and protocols for the Laboratory Response 

Network (LRN). The presence of anthrax on this list led to the focused preparedness 

efforts on drug stockpiles and diagnostic tests that were available during the 2001 

anthrax attack.

A number of similar lists do exist such as the military’s formal assessment of multiple agents for their strategic usefulness on the battlefield; an international list of 

agents for export control; a list of agents that have been processed for biowarfare; 

and classified lists. Most of these lists focused on biowarfare, but for public health 

preparedness purposes, CDC needed a list of agents that could have significant impact on the U.S. population. To guide the national public and medical health bioterrorism preparedness and response efforts, we devised a method for assessing potential biological threat agents that would provide a reviewable, reproducible means for 

standardized evaluations of these threats. Identifying these priority agents helps facilitate coordinated planning efforts among federal agencies, state and local emergency response and public health agencies, and the medical community.

Overview of Agent Selection and Prioritization Process 

In June 1999, CDC convened a meeting of academic infectious disease experts, national public health experts, Department of Health and Human Services agency representatives, civilian and military intelligence experts, and law enforcement officials 

to review and comment on the threat potential of various agents to civilian populations. While biological agents can cause illness in humans, not all are capable of 

affecting public health and medical infrastructures on a large scale. The following 

four general criteria were used to assess this public health impact: 1) the anticipated amount of illness and death with an agent; 2) the delivery potential to large 

populations based on stability of the agent, ability to mass produce and distribute 

a virulent agent, and potential for person-to-person transmission; 3) the public perception as related to fear and potential civil disruption; and 4) the special public 

health preparedness needs based on stockpile requirements, enhanced surveillance, 

or diagnostic tools necessary to respond to a deliberate dissemination of an agent. 

These last two criteria were the unique features of the public health critical agent 

list.

Participants discussed and identified these four criteria and reviewed available lists 

to subjectively place agents they felt had the potential for high impact. Participants 

with appropriate clearance levels also reviewed intelligence information regarding 

classified suspected biological agent threats to civilian populations. Genetically engineered or recombinant biological agents were considered but not included for final 
16

prioritization because of the inability to predict the nature of these agents and thus 

identify specific preparedness activities for public health and medical response to 

them. In addition, no information was available about the likelihood for use of one 

biological agent over another. This aspect, therefore, could not be considered in the 

final evaluation of the potential biological threat agents.

After the meeting, CDC personnel then attempted to identify objective indicators in 

each category that could be used to further define and prioritize the identified high 

impact agents and provide a framework for an objective risk-matrix analysis process 

for any potential agent. The agents were evaluated in each of the general areas according to the objective parameters. Final category assignments (A, B, or C) of 

agents for public health preparedness efforts were then based on an overall evaluation of the ratings the agents received in each of the four areas.

Categories of Agents 

Based on the overall criteria and weighting, agents were placed in one of three priority categories for initial public health preparedness efforts: A, B, or C. Agents in 

Category A have the greatest potential for adverse public health impact with mass 

casualties, and most require broad-based public health preparedness efforts (e.g., 

improved surveillance and laboratory diagnosis and stockpiling of specific medications). Category A agents also have a moderate to high potential for large-scale dissemination or a heightened general public awareness that could cause mass public 

fear and civil disruption.

Most Category B agents also have some potential for large-scale dissemination with 

resultant illness, but generally cause less illness and death and therefore would be 

expected to have lower medical and public health impact. These agents also have 

lower general public awareness than Category A agents and require fewer special 

public health preparedness efforts. Agents in this category require some improvement in public health and medical awareness, surveillance, or laboratory diagnostic 

capabilities, but presented limited additional requirements for stockpiled therapeutics beyond those identified for Category A agents. Biological agents that have 

undergone some development for widespread dissemination but do not otherwise 

meet the criteria for Category A, as well as several biological agents of concern for 

food and water safety, are included in this category.

Biological agents that are currently not believed to present a high bioterrorism risk 

to public health but which could emerge as future threats (as scientific understanding of these agents improves) were placed in Category C. These agents will be 

addressed nonspecifically through overall bioterrorism preparedness efforts to improve the detection of unexplained illnesses and ongoing public health infrastructure development for detecting and addressing emerging infectious diseases.

Agents were categorized based on the overall evaluation of the different areas considered. For example, smallpox would rank higher than brucellosis in the public 

health impact criterion because of its higher untreated mortality (approximately 30 

percent for smallpox and less than or equal to 2 percent for brucellosis); smallpox 

has a higher dissemination potential because of its capability for person-to-person 

transmission. Smallpox also ranks higher for special public health preparedness 

needs, as additional vaccine must be manufactured and enhanced surveillance, educational, and diagnostic efforts must be undertaken. Inhalational anthrax and 

plague also have higher public health impact ratings than brucellosis because of 

their higher morbidity and mortality. Although mass production of Vibrio cholerae 

(which causes cholera) and Shigella species (which cause shigellosis) would be easier 

than the mass production of anthrax spores, the public health impact of widespread 

dissemination would be less because of the lower morbidity and mortality associated 

with these agents and because of some of the preparedness efforts implemented for 

other agents such as drug stockpiles.

The above categories of agents should not be considered definitive. Agents in each 

category may change as new information is obtained or new assessment methods 

are established. To date, changes to these lists have not been warranted. Disease 

elimination and eradication efforts may result in new agents being added to the list 

as populations lose their natural or vaccine-induced immunity to these agents. Conversely, the priority status of certain agents may be reduced as the identified public 

health and medical deficiencies related to these agents are addressed (e.g., once adequate stores of smallpox vaccine and improved diagnostic capabilities are established, its overall rating within the risk-matrix evaluation process might be reduced). To meet the ever-changing response and preparedness challenges presented 

by bioterrorism, a standardized and reproducible evaluation process similar to the 

one outlined above will continue to be used to evaluate and prioritize currently iden-
17

tified biological critical agents, as well as new agents that may emerge as threats 

to civilian populations or national security.

Conclusion 

In conclusion, CDC is committed to working with other Federal agencies, academia, 

and other partners, as well as State and local public health departments, to ensure 

the health and medical care of our citizens. We have made substantial progress to 

date in enhancing the Nation’s capability to prepare for and respond to a bioterrorist event. The best public health strategy to protect the health of civilians against 

a biological attack is the development, organization, and enhancement of public 

health prevention systems and tools. Priorities include strengthened public health 

laboratory capacity; increased surveillance and outbreak investigation capacity; and 

health communications, education, and training at the Federal, State, and local levels. Not only will this approach ensure that we are prepared for deliberate bioterrorist threats, but it will also ensure that we will be able to recognize and control 

naturally occurring new or re-emerging infectious diseases such as SARS or pandemic influenza. A strong and flexible public health infrastructure is the best defense against any disease outbreak.

Thank you very much for your attention. I will be happy to answer any questions 

you may have.

Ms. DUNN. [Presiding.] Thank you very much, Dr. Khan. And 

next we will hear from Dr. LaMontagne, who is the deputy director 

of the National Institute of Allergy and Infectious Diseases for the 

National Institutes of Health. May I just suggest to you, Dr. 

LaLantagne, the speakers are not aimed in our direction, and if 

you could speak slowly and precisely, we will give you the extra 

time you need, but it is very difficult to hear. The acoustics in this 

room are terrible. Go ahead, Dr. LaMontagne. 

STATEMENT OF JOHN RING LaMONTAGNE, PH.D., DEPUTY DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH, U.S. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Dr. LAMONTAGNE. Thank you very much, Madam Chair and 

members of the Committee. Thank you for giving me the opportunity to discuss the comprehensive and accelerated process for developing medical countermeasures against bioterrorist threats. As 

you know, the National Institutes of Health, particularly the National Institute of Allergy and Infectious Diseases, of which I am 

Deputy Director, is engaged in a vigorous effort to ensure homeland security and protect the American people against potential 

agents of bioterrorism, as well as emerging and reemerging infectious diseases. 

Integral to this effort is the enactment of Project BioShield which 

will increase the authority and flexibility of the NIH to expedite research towards the development of critical medical countermeasures for biodefense. 

Today I will describe for you, one, how the NIAID has set up its 

research priorities to develop vaccines and therapeutics against bioterrorist threats; two, why NIAID has identified certain biological 

agents as its top research priorities and, third, what NIAID is 

doing to ensure that medical countermeasures, particularly vaccines and therapeutics, are developed as rapidly as possible to protect homeland security. 

The NIAID set its research priorities for defense against bioterrorism through a comprehensive and systematic process. Since February of 2002, we have convened four multi-institutional panels of 

scientific experts and developed a strategic plan and a strategic re-
18

search agenda based on their recommendations. For example, 

based on advice of the Blue Ribbon Panel on Bioterrorism and Its 

Implications for Biomedical Research, we developed the NIAID 

Strategic Plan for Biodefense Research and the NIAID Research 

Agenda for CDC Category A Agents. 

Strategic plan emphasizes, first of all, basic research on microbes 

and host defenses; second, targeted milestone-driven development 

of drugs, vaccines, other interventions and diagnostics. 

The NIAID defense research agenda emphasizes the short-term, 

intermediate, and long-term goals for research in Category A 

agents, a group of microbes and toxins that you have just heard 

about identified by the CDC as the most dangerous. These include 

anthrax, smallpox, plague, botulinum toxin, tularemia, and hemorrhagic fevers caused by viruses such as Ebola. 

Thus, the initial focus of our biodefense research effort has been 

to develop new and improved vaccines, therapeutics and diagnostic 

tests against Category A agents. An essential component of this 

program is enhancing the Nation’s capability to conduct research 

on these agents. This requires that additional high-containment research facilities known as BSL 3, or biosafety level 3, and BSL 4 

laboratories be constructed and made accessible to governmentsupported scientists. Also required to fulfill the goals of our research program are other specialized research resources such as 

centers for sequencing the genomes of these microbes and skilled 

scientists and technicians who are trained to handle dangerous microbes and toxins. 

In addition to research on Category A agents, NIAID is also 

spearheading efforts to develop new and improved vaccines, therapeutics, and diagnostics for Category B and C agents as well. 

Again, based on the recommendations of a blue ribbon panel, we 

developed the NIAID biodefense Research Agenda for Category B 

and C Priority Pathogens. These agents include a diverse array of 

viruses, bacteria and bacterial toxins that are carried by insects, 

livestock, and other vectors; can be inhaled; or are spread through 

contaminated food and water. 

I have indicated that the NIAID biodefense program emphasizes 

research on Category A agents: anthrax, smallpox, plague, botulinum, tularemia, and Ebola and other hemorrhagic fever viruses. 

Why are these viruses, bacteria and toxins considered the more 

dangerous potential agents of bioterrorism? Many of the microbes, 

such as those that cause measles, mumps or even AIDS cause serious illness that are not in a Category A list. 

Simply put, the high priority Category A agents include organisms that can pose a risk to national security, because they, first 

of all, can be easily disseminated and transmitted from person to 

person. They result in higher mortality rates and have a potential 

for major public health impact. They might cause public panic and 

social disruption. They require special action for public health preparedness. 

In Category B agents are considered to have the second highest 

priority in terms of the bioterrorist threat potential. These agents 

are moderately easy to disseminate, result in moderate morbidity 

rates and low mortality rates and require specific enhancements of 

our diagnostic capacity and enhanced disease surveillance. 
19

Category C agents, the next highest priority, include emerging 

microbes 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 obviously a major health impact. 

In general, the NIAID has three broad goals in vaccine research. 

The first is to identify new vaccine candidates to prevent disease 

for which no vaccines currently exist, improve the safety and efficacy of existing vaccines and, third, to design novel vaccine approaches such as the use of new vectors or adjuvants. 

To achieve these goals, NIAID supports basic research to understand the biology of the microbes that cause disease and to determine how humans and other animals respond to infection with 

these microbes. Key to our understanding of microbial biology is 

identification of the nucleic acid sequence of their genomes. With 

this information in hand, we will be better poised to identify molecular targets to use in the design of vaccines and therapeutics. 

Another primary objective of the NIAID biodefense research program is to attract the long-term interest and support of academia 

and industry in the efforts needed to develop effective bioterrorism 

countermeasures. 

NIAID’s biodefense research program facilitates the involvement 

of academic scientists through the use of all available funding 

mechanisms including the development of a network of Regional 

Centers of Excellence for research on bioterrorism and emerging 

and reemerging infectious diseases. 

Our biodefense strategic plan and research agenda has required 

an expansion of investigator-initiated and institute-initiated grants 

and contracts. In Fiscal Year 2002 and 2003, NIAID developed a 

total of 46 different biodefense initiatives to stimulate research in 

this area. Thirty are totally new, and 16 are significant expansion. 

During this time, NIAID has also seen a 30 percent increase in the 

number of grant applications. The vast majority of these are in response to our biodefense initiatives. 

In closing, thank you again for giving me opportunity to testify 

today before you about NIAID’s biodefense research agenda. I 

would be pleased to answer any questions you might have. 

Ms. DUNN. Thank you very much, Dr. LaMontagne. 

[The statement of Dr. LaMontagne follows:]

PREPARED STATEMENT OF DR. JOHN R. LAMONTAGNE 

Mr. Chairman and Members of the Committee, thank you for giving me the opportunity to discuss the comprehensive and accelerated process for developing medical 

countermeasures against bioterrorist threats. As you know, the National Institutes 

of Health (NIH), particularly the National Institute of Allergy and Infectious Diseases (NIAID), of which I am Deputy Director, is engaged in a vigorous effort to 

ensure homeland security and protect the American people against potential agents 

of bioterrorism as well as emerging and re-emerging infectious diseases.

The destruction of the World Trade Center, the attack on the Pentagon, and the anthrax attacks in the fall of 2001 starkly exposed the vulnerability of the United 

States to acts of terrorism. At the NIH, and particularly at the NIAID, these events 

triggered the development of an aggressive, broadly based research program designed to provide the American people with vaccines and therapeutics against a 

range of bioterrorist threats.

Integral to this effort is the enactment of Project BioShield, which will increase the 

authority and flexibility of NIH to expedite research toward the development of crit-
20

ical medical countermeasures for biodefense. Project BioShield would also establish 

a secure funding source for the purchase of critical medical countermeasures, and 

would give the Food and Drug Administration (FDA) an Emergency Use Authorization for these countermeasures. Thus, the accelerated research and development 

program of the NIH, and the NIAID in particular, would work in concert with 

Project BioShield to provide the American people with safe and effective vaccines 

and therapeutics to protect them against a range of biological threats.

Today, I will describe to you: (1) how the NIAID has set its research priorities to 

develop vaccines and therapeutics against bioterrorist threats; (2) why NIAID has 

identified certain biological agents as its top research priorities; and (3) what NIAID 

is doing to ensure that medical countermeasures—particularly vaccines and therapeutics—are developed as rapidly as possible to protect homeland security.

Overview 

For years, civilian agencies such as the NIH, the FDA, the Centers for Disease Control and Prevention (CDC), as well as the U.S. Army Medical Research Institute of 

Infectious Diseases (USAMRIID) in the Department of Defense (DoD), have addressed the threat of bioterrorism. The research has been directed at viruses, bacteria, and bacterial toxins that could emerge or re-emerge spontaneously in nature, 

or that could be intentionally released as biological weapons into human populations. However, the anthrax attacks of 2001 revealed significant gaps in our overall preparedness against bioterrorism, and gave a new sense of urgency to our biodefense research efforts.

We realized quickly that it was no longer adequate to do business as usual. A primary goal of the NIH has always been to support research efforts that generate new 

knowledge about disease and to translate these findings into vaccines, therapeutics, 

and diagnostics that protect public health. But, to develop safe and effective products for biodefense as quickly as possible, we needed to intensify and accelerate this 

process. Thus, we sought creative ways in which to modify NIH’s traditional process 

of research and development, while continuing to preserve the excellence that is a 

hallmark of NIH research. The NIAID biodefense research program is directed primarily toward the needs of civilian populations, although interventions emerging 

from it may logically also have application in military settings.

How has NIAID set its research priorities to develop vaccines and therapeutics against bioterrorist threats?

Bioterrorism is defined as the intentional use of microorganisms that cause human 

disease, or of toxins derived from them, to harm individual people or to elicit widespread fear or intimidation of society.

The NIAID set its research priorities for defense against bioterrorism through a 

comprehensive and systematic process. Since February of 2002, we have convened 

four multi-institutional panels of scientific experts, and developed a strategic plan 

and strategic research agendas based on their recommendations. Based on advice 

from the Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research, we developed the NIAID Strategic Plan for Biodefense Research and the 

NIAID Research Agenda for CDC Category A Agents. The Strategic Plan emphasizes: 1) basic research on microbes and host defenses; and 2) targeted, milestonedriven development of drugs, vaccines, other interventions, and diagnostics. The 

NIAID Biodefense Research Agenda emphasizes the short-term, intermediate, and 

long-term goals for research on Category A agents, a group of microbes and toxins 

identified by the CDC as the most dangerous. These include anthrax, smallpox, 

plague, botulism, tularemia, and hemorrhagic fevers caused by viruses such as 

Ebola.

Thus, the initial focus of our biodefense research effort has been to develop new and 

improved vaccines, therapeutics, and diagnostics against Category A agents. An essential component of this program is enhancing the Nation’s capability to conduct 

research on these agents. This requires that additional high-containment research 

facilities, known as BioSafety Level-3 (BSL–3) and BSL–4 laboratories, be constructed and made accessible to government-supported scientists. Also required to 

fulfill the goals of our research program are other specialized research resources 

such as centers for sequencing the genomes of these microbes, and skilled scientists 

and technicians who are trained to handle dangerous microbes and toxins.

In addition to research on Category A agents, NIAID is also spearheading efforts 

to develop new and improved vaccines, therapeutics, and diagnostics for Category 

B and C agents. Again, based on the recommendations of a blue ribbon panel, we 

developed the NIAID Biodefense Research Agenda for Category B and C Priority 
21

Pathogens. These agents include a diverse array of viruses, bacteria, and bacterial 

toxins that are carried by insects, livestock, or other vectors; can be inhaled; or are 

spread through contaminated food and water. They include the bacteria that cause 

typhus and cholera, and viruses such as West Nile virus, which is carried by mosquitoes, and tick-borne encephalitis virus. As is the case for the Category A agents, 

NIAID research on Category B and C agents is designed to understand the biology 

of the microbe and the host response to the microbe, and to use that knowledge as 

the basis for developing safe and effective vaccines and other medical countermeasures.

Why has NIAID identified certain biological agents as its top research priorities?

I have already indicated that the NIAID biodefense program emphasizes research 

on Category A agents: anthrax, smallpox, plague, botulism, tularemia, Ebola and 

other hemorrhagic fever viruses. Why are these viruses, bacteria, and toxins considered the most dangerous potential agents of bioterrorism? Many other microbes, 

such as those that cause measles, mumps, or even AIDS, cause serious illness but 

are not on the Category A list. Simply put, the high-priority Category A agents include organisms that pose a risk to national security because they:

• Can be easily disseminated or transmitted from person to person 

• Result in high mortality rates and have the potential for major public health impact 

• Might cause public panic and social disruption 

• Require special action for public health preparedness

Category B agents are considered to have the second highest priority in terms of 

their bioterrorist threat potential. These agents are moderately easy to disseminate, 

result in moderate morbidity rates and low mortality rates, and require specific enhancements of our diagnostic capacity and enhanced disease surveillance. 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.

What is NIAID doing to ensure that vaccines and therapeutics are developed as rapidly as possible to protect homeland security?

The process by which NIAID is developing safe and effective countermeasures for 

biodefense is complex and multifaceted. I would like to describe, in general terms, 

how we develop vaccines. I will relate this process to the specific development of 

vaccines and therapeutics for biodefense.

In general, the NIAID has three broad goals in vaccine research:

• Identifying new vaccine candidates to prevent diseases for which no vaccines currently exist. 

• Improving the safety and efficacy of existing vaccines. (NIAID researchers are collaborating with colleagues at USAMRIID, and with private industry, to develop and 

test safer, next-generation vaccines for smallpox and anthrax.) 

• Designing novel vaccine approaches, such as new vectors and adjuvants (Scientists at the NIAID Vaccine Research Center are working to develop gene-based 

vaccines for Ebola and related viruses.)

To achieve these goals, NIAID supports basic research to understand the biology of 

the microbes that cause disease and to determine how humans and other animals 

respond to infection with these microbes. Key to our understanding of microbial biology is identifying the nucleic acid sequence of their genomes. With this information 

in hand, we will be better poised to identify molecular targets to use in the design 

of vaccines or therapeutics. Recently, for example, two teams of NIAID-funded researchers at The Institute for Genomic Research in Rockville, MD, reported the 

complete genetic sequence of the strain of Bacillus anthracis used in the 2001 anthrax mail attacks, and the complete genomic sequence of the Q-fever pathogen and 

Category B agent, Coxiella burnetii.

In addition to understanding how a microbe causes disease, it is also important to 

understand how animals and humans respond to microbial infection. NIAID supports research on innate and adaptive immune responses in a range of animal models and in humans. We also are working to understand how certain pathogens evade 

immune surveillance and use this information to design ways to trigger a protective 

immune response. We are investigating new immunostimulatory agents that boost 

the effectiveness of vaccines. Additionally, we need to understand how immune re-
22

sponses vary in different individuals according to age, general health status, genetic 

makeup, and treatment with immunosuppressive drugs.

Developing new and improved vaccines and therapeutics also requires a strong clinical infrastructure. NIAID supports Vaccine and Treatment Evaluation Units, which 

conduct human clinical trials to determine the safety and efficacy of candidate vaccines for infectious diseases, including several caused by Category A, B, and C 

agents. This network has served as a national resource for the independent evaluation of vaccines since 1992.

Another primary objective of the NIAID biodefense research program is to attract 

the long-term interest and support of academia and industry in the efforts needed 

to develop effective bioterrorism countermeasures. NIAID’s biodefense research program facilitates the involvement of academic scientists through the use of all available funding mechanisms, including the development of a network of Regional Centers of Excellence for research on bioterrorism and emerging and re-emerging infectious diseases.

Key to the development of safe and effective medical countermeasures for biodefense 

are collaborations with private industry. Since the Fall of 2001, we have strengthened and expanded our interactions with the private sector, including biotechnology 

companies and pharmaceutical manufacturers. Many biodefense products will not 

provide sufficient incentives for industry to develop on their own, because a profitable market for these products cannot be guaranteed. Therefore, NIAID has developed public-private partnerships to overcome these obstacles. Also, the passage of 

Project BioShield, which would authorize the purchase of biodefense countermeasures, would provide a much-needed incentive to participate in this effort.

Our biodefense strategic plan and research agenda has required an expansion of investigator-initiated and Institute-initiated grants and contracts. In Fiscal Years 

2002 and 2003, NIAID developed a total of 46 biodefense initiatives to stimulate research: 30 are new initiatives and 16 are significant expansions. During this same 

time period, NIAID has seen a 30 percent increase in the number of grant applications; the vast majority of these are in response to our biodefense initiatives.

Still another important element in our biodefense research program is an enhancement of Intramural research. Of note, the NIAID Vaccine Research Center, is working on the development of new and improved vaccines against a range of bioterrorist 

threats, including the Ebola virus, as well as a next-generation vaccine against 

smallpox.

Related to our biodefense preparedness research program is a more recent, NIHwide effort to develop effective countermeasures against chemical and nuclear/radiological weapons. We recognize the NIH may not necessarily have a predominant role 

in developing countermeasures for these threats, although we must still be prepared 

for any eventuality. Dr. Elias Zerhouni, the director of NIH, has established the 

NIH Biodefense Research Coordinating Committee to facilitate and coordinate the 

development of a research agenda and to implement R&D programs that address 

relevant aspects of chemical and nuclear/radiological threats. Dr. Anthony S. Fauci, 

the director of NIAID, serves as committee chairman.

That concludes my testimony. I would be happy to answer any questions you may 

have.

Ms. DUNN. It was a little difficult to hear, and so I would like 

to know from you, both you gentlemen, the list that we talked 

about, the categories A, B and C that are current priorities, how 

will they compare, do you believe, over what you expect to recommend to the Secretary as your bioterrorism threat prioritizations 

as we move into the future? 

Dr. LAMONTAGNE. Well, I would say that we strongly believe the 

Category A agents represent the major threats, and within that list 

three major targets, I think, for which there is probably unanimous 

agreement is smallpox, anthrax and botulism, but all of the agents 

on that list—all seven of the category A agents, I think, are considered to be important targets. 

Dr. KHAN. Let me state that the list that we are talking about 

are the identical lists, so NIH at least has coordination between 
23

CDC and NIH on these same lists. And, again, our State and local 

health departments and the medical community agree on the nature of those lists and how they were put together. The criteria to 

put together those lists and the agent remain valid currently, and 

the agents within them and the way they were prioritized also appear to remain valid. The Agency already reevaluates this process 

on a yearly basis as they provide new guidance to State and local 

health departments to verify that the lists are valid. 

Ms. DUNN. Thank you. Yesterday we had a hearing in which we 

discussed these issues with the man in charge for the Department 

of Homeland Security, and I think we all had some question that 

over the next 10 years we are going to be spending $5.6 billion on 

this program. We want to make sure that DHS can handle it. A 

few months ago, the SARS epidemic struck North America and the 

rest of the world. Not knowing at the beginning whether this was 

a biological attack, how did the Department of Homeland Security 

work with both of your organizations in responding to the outbreak? What organizational structure was established? And were 

you effectively able to work through that problem? 

Dr. LAMONTAGNE. Well, I think in response to the question about 

interaction or communication with homeland security, I think that 

given the youth of the organization and the idea of homeland security, that is, I think that our interactions have been actually quite 

good. We do have frequent meetings with them. There are meetings 

at the departmental level as well, but I am not perceiving that 

there is an inability to communicate with them pretty effectively on 

these issues. I think we do. 

Dr. KHAN. Let me make a comment about SARS. I just came 

back from 5 weeks in Singapore assisting them with the SARS outbreak, and I asked for consultation with Mr. Joe Henderson about 

this question in preparation for this question, and, yes, CDC did 

work with DHS to discuss the SARS outbreak. 

Let me state that we have been doing this for a number of years. 

We did it for the West Nile outbreak when it was originally identified in the United States to verify that it was not bioterrorism. 

There are also published guidelines on how we evaluate epidemics, 

coauthored by CDC and the FBI to go through the epidemiologic 

and laboratory criteria on how to investigate an outbreak and say 

whether or not you think it is bioterrorism. 

For specific comments about our current relationships and structure with DHS, if you would allow me, I believed defer to Mr. Henderson who can talk about our specific relationships. 

Mr. HENDERSON. Thank you for the opportunity to make a few 

additional comments on what Dr. Khan had mentioned regarding 

our work with homeland security. It is a new forming organization, 

and we are working with them closely. When SARS first appeared, 

of course the first thing we were concerned with was that it was, 

in fact, potentially a terrorism event. Since September 11th, that 

is the way our thinking has been in relation to emerging diseases 

and outbreaks globally. We have, I think, additional room to work 

with homeland security to make sure that we have a process in 

place to rapidly analyze information regarding potential terrorist 

threats, but we do have a routine communication with homeland 

security on these issues. 
24

Ms. DUNN. Thank you, gentlemen. Dr. Khan, you mentioned in 

your statement that both civilian and military intelligence experts 

were parts of the panel that the CDC established in 1999 to help 

formalize and prioritize the categories A, B, and C biological agents 

and you also mentioned that participants with appropriate clearance levels also reviewed the intelligence information regarding 

classified suspected biological agent threats to civilian populations. 

Can you tell us what agencies within the Intelligence Community 

participated on your panel generically and at an unclassified level 

can you explain how this information was analyzed? For example, 

is the information a product or raw or analyzed information. Is this 

collaboration still ongoing? 

Dr. KHAN. We can submit to the committee a complete list of 

agencies and individuals who were present at that briefing if they 

would request. As far as putting the list together, the purpose of 

the list was actually to try to develop something that would not be 

classified and be available for the whole public health and medical 

community. So we took the information that was available on the 

biowarfare agents and extrapolated that to what would happen in 

specific categories if they were used on civilian populations. That 

allowed us to go from what would essentially be considered some 

sort of classified information to unclassified public use information 

that would be used for preparedness purposes. 

Ms. DUNN. Looking forward to that list. Thank you very much, 

gentlemen. And now, Congressman Turner, would you like to ask 

your questions for 5 minutes? 

[The information follows:]

Participants in CDC Critical Biological Agents for Public Health Preparedness Meeting, 

June 3–4, 1999

Donald A. Henderson, M.D., M.P.H. 

Director, 

Johns Hopkins Center for Civilian Biodefense Studies

Thomas Inglesby, M.D. 

Johns Hopkins Center for Civilian Biodefense Studies

Dennis Perrotta, Ph.D. 

Chief, Bureau of Epidemiology, 

Texas Department of Health

Mike Osterholm, M.D., M.P.H. 

Chair and CEO 

Infection Control and Advisory Network, Inc.

Kenneth Bernard, M.D. 

Special Advisor to the Assistant to the 

President of the United States on National Security

Kathy Zoon, Ph.D. 

Director, Center for Biologics Evaluation and Research 

Food and Drug Administration

Mark Elengold 

Deputy Director, Center for Biologics 

Evaluation and Research 

Food and Drug Administration
25

Participants in CDC Critical Biological Agents for Public Health Preparedness Meeting, 

June 3–4, 1999—Continued

George Hughes 

Special Agent 

Office of Criminal Investigations 

Office of Regional Affairs 

Food and Drug Administration

John Taylor 

Senior Advisor for Regulatory Policy 

Office of the Commissioner 

Food and Drug Administration

Martha Girdany 

Biological and Chemical Group 

DCI Nonproliferation Center

Kathleen Kuker 

Director, Weapons of Mass Destruction Operations 

Federal Bureau of Investigations

Howard Stirne, M.D. 

Consultant, Medical Coordinator, SWAT EOD 

Federal Bureau ofInvestigations

Jeff Mazanec 

Supervisory Special Agent, 

Joint Terrorism Task Force 

Federal Bureau ofInvestigations

Arlene Reidy 

Department of Justice

Ted Plasse, M.S. 

Defense Intelligence Agency 

Biological Warfare Group

LTC Ted Cieslak, M.D. 

US Army Medical Research 

Institute of Infectious Diseases

William Raub, Ph.D. 

Deputy Assistant Secretary for Science Policy 

Department of Health and Human Services

Amandeep Matharu

Scott Lillibridge, M.D. 

Director, Bioterrorism Preparedness and Response Program 

National Center for Infectious Diseases 

Centers for Disease Control and Prevention

Steve Ostroff, M.D. 

Associate Director for Epidemiologic Science 

National Center for Infectious Diseases 

Centers for Disease Control and Prevention

James LeDuc, Ph.D. 

Associate Director for Global Health 

National Center for Infectious Diseases 

Centers for Disease Control and Prevention

Ali Khan, M.D. 

Deputy Director, Epidemiology and Surveillance 

Bioterrorism Preparedness and Response Program 

Centers for Disease Control and Prevention

C.J. Peters, M.D. 

Chief, Special Pathogens Branch 

Division of Viral and Rickettsial Diseases 

National Center for Infectious Diseases
26

Participants in CDC Critical Biological Agents for Public Health Preparedness Meeting, 

June 3–4, 1999—Continued

Budget Examiner for Bioterrorism and Food Safety 

Office of Management and Budget 

Department of Health and Human Services

RADM Robert Knouss, M.D. 

Director, Office of Emergency Preparedness 

Department of Health and Human Services

CDR Kevin Tonat, Dr.P.H., M.P.H. 

Special Assistant to the Director 

Office of Emergency Preparedness 

Department of Health and Human Services

John La Montagne, Ph.D. 

Deputy Director, National Institute of 

Allergy and Infectious Diseases 

National Institutes of Health

James Hughes, M.D. 

Director 

National Center for Infectious Diseases 

Centers for Disease Control and Prevention

Centers for Disease Control and Prevention

Robert Craven, M.D. 

Chief, Epidemiology Section, 

Arbovirus Diseases Branch 

Division of Vector-Borne Infectious Diseases 

National Center for Infectious Diseases

Joseph Esposito, Ph.D. 

Chief, Poxvirus Section, Viral Exanthems and 

Herpesvirus Branch 

Division of Viral and Rickettsial Diseases 

National Center for Infectious Diseases 

Centers for Disease Control and Prevention

David Ashford, D.V.M., M.P.H. 

Meningitis and Special Pathogens Branch 

Division of Bacterial and Mycotic Diseases 

National Center for Infectious Diseases 

Centers for Disease Control and Prevention

David Swerdlow, MD 

Foodborne and Diarrheal Diseases Branch 

Division of Bacterial and Mycotic Diseases

National Center for Infectious Diseases 

Centers for Disease Control and Prevention

Steve Bice 

Chief, National Phannaceutical Stockpile Branch 

Division of Emergency and Environmental 

Health Services 

National Center for Environmental Health 

Centers for Disease Control and Prevention

Lisa Rotz, M.D. 

Bioterrorism Preparedness and Response Program 

National Center for Infectious Diseases 

Centers for Disease Control and Prevention

Peg Tipple, M.D. 

Assistant Director of Medical Science, 

Office of Health and Safety 

Office of the Director 

Centers for Disease Control and Prevention
27

Participants in CDC Critical Biological Agents for Public Health Preparedness Meeting, 

June 3–4, 1999—Continued

Bryan Hardin, Ph.D. 

Deputy Director 

National Institute for Occupational Safety and Health 

Centers for Disease Control and Prevention

Scott Deitchman, M.D. 

National Institute for Occupational Safety and Health 

Centers for Disease Control and Prevention

Arnold Kaufmann, Ph.D. 

Emergency Response and Coordination Group 

National Center for Environmental Health 

Centers for Disease Control and Prevention

DDonald Shriber, M.P.H. 

Associate Director/Washington 

Centers for Disease Control and Prevention

Martha Katz 

Deputy Director for Policy and Legislation 

Office of the Director 

Centers for Disease Control and Prevention 

Mr. TURNER. Thank you, Madam Chairman. Dr. LaMontagne, I 

want to start with you and ask a couple of questions. 

Under the BioShield legislation that is before this committee, the 

funding that has been talked about so much and has been modified 

as it has moved forward through the process of congressional hearings, is dedicated to ‘‘security countermeasures’’ which are defined 

under the bill as ‘‘approved drugs or drugs that have sufficient clinical experience or research data to qualify for approval or licensing 

at a later date.’’ Now, one of the concerns that I have had about 

BioShield is that the much talked about funding is limited to that 

stage at the end of the process after the vaccine has been discovered, after it has been tested at an applied research level, after all 

that is done. Only then is the BioShield funding available to contract with the private company to go through the final stages of 

clinical trials and production of the vaccine. That is what is referred to oftentimes by Dr. Fauci as the pull side of the equation. 

I am more interested in, because of the area that you work in, understanding the push side of this process. And I know that the creation of the Center for Vaccine Research deals with a broad category of potential threats. I think it was originally created to try 

to deal with AIDS. But you obviously have expanded it and it is 

now the entity that would deal with the basic research, the applied 

research, and developing the vaccines necessary to meet these biological threats that we have talked about. 

I am very interested in how you view the capability that you currently have, even with the expanded funding, to provide the leadership that is necessary to do the basic research and the applied research to come up with the vaccines that can be moved to the final 

stages, develop as and produced the private sector. Could you give 

us some feel for your capacity to accomplish that task? 

Dr. LAMONTAGNE. Well, I will try. That is a complicated set of 

questions. But let me begin by clarifying something about the Vac-
28

cine Research Center, which, as you said, is the unit which is on 

the NIH campus which is part of our Institute dedicated to the development of vaccines. And it was created 4 years ago or so with 

the express notion that it would focus on AIDS vaccines. It has expanded its agenda in a clear reflection of the pressures and priorities that the Nation is facing to add to its activities some very important work in other vaccines, particularly Ebola virus and West 

Nile, which are two very interesting projects that it has currently 

underway. 

The process of vaccine development or countermeasure development, however you want to phrase it, particularly for biodefense 

agents, is a very complex one because for one thing the marketability of these products at the end of the process is limited. Secondly, the ability to test these materials in the traditional randomized clinical trial settings that we have become accustomed to, for 

example, for AIDS drugs or for other vaccines is simply not available. There are not enough anthrax cases, for example—anthrax, 

fortunately is not a common disease, plague is not a common disease, Ebola is not a common disease. To satisfy the standards for 

efficacy and safety that one might require under normal circumstances, we have had to adapt to what the FDA is now referring to as the two-animal rule. In other words, we will seek to gain 

evidence of the efficacy of these materials by testing them in a very 

rigorous manner. There is not going to be any compromises here 

in terms of their ability to elicit protective responses in at least two 

different animal model systems. We will then use that information 

in addition to information obtained in clinical trials of the antigenicity of these or the immunogenicity, the ability of these vaccines, 

for example, to elicit protective immune responses in humans and 

compare those to what we see in the animal model systems. Based 

on that information we should be able to assess whether or not a 

particular vaccine is of the quality that will provide the kinds of 

protection that are needed to prevent disease following a challenge 

from whatever source. 

I should just conclude my remarks by saying there is another 

very difficult aspect to this, and that is what you can do in a laboratory; for example, the Vaccine Research Center can make candidate vaccines in the 10,000 to 20,000 dose range. When you are 

talking about vaccines that are going to be required in the millions 

or tens of millions of dose ranges, you require an amplification of 

production capacity that really only exists in the private sector. So 

we have to develop methods or ways of attracting and bringing the 

private sector into this process early on so that they can then take 

the handoff when it is appropriate and move those vaccines into 

the level of production that is going to be required to meet a national challenge such as the one we are facing. 

I hope that answers your question. 

Mr. TURNER. I will follow up with you on my next round of questioning. Thank you, Doctor. 

Chairman COX. [Presiding.] Thank you. The Chair recognizes 

himself for 5 minutes. What we are interested in here today, in 

particular, is to propose the role for the Department of Homeland 

Security because nothing that gets funded under Project BioShield 

for ultimate stockpiling and use can go forward unless there is a 
29

materiality determination by the Secretary of Homeland Security 

under the terms of the proposed statute; that is, the statutory 

scheme, so very literally the determination, responsibility exercised 

by the Secretary of Homeland Security is the linchpin of all of the 

scientific work that proceeds and all the monies that get spent in 

support of it and in support of the stockpile. 

I have every confidence that CDC, NIAID, are competent to determine the relative lethality of the different agents that might be 

used against our human population, against American people as 

the result of a terrorist attack or military threat. But the job of 

Homeland Security encompasses more than that. We have to have 

some notion of what are the capabilities of terrorist groups, what 

are the capabilities of states or other individuals or organizations; 

second, what are the means that these states or terrorist groups or 

individuals might use to deploy those weapons; and, third, perhaps 

most important, what is the probability of that happening given 

their capabilities and given the means of deploying the weapons. 

Ultimately, of course we have to go back then to the science and 

say if they are going to deploy in this fashion, given their capabilities what would be the relative lethality, what would be the effect 

and, summing it all up, is that material? 

I first want to ask you whether or not either of your organizations has any analytical capability with respect to identifying terrorist groups, states, individuals or organizations who possess 

these agents or the capacity to manufacture and deploy them and, 

second, whether or not you believe that that is something that if 

you can’t do, that Homeland Security will be able to get its arms 

around and interface with you so that you can do the crosswalk because you have information that their analysis is dependent upon 

and vice versa? 

Dr. Khan and Dr. LaMontagne, in either order. 

Dr. KHAN. Let me start by saying that as we devise these critical 

agents lists, it was—the criteria that were put together were more 

than the lethality and the mortality of the agent. We tried to integrate in what was known about whether these agents had been 

weaponized and previously used potentially and how these agents 

would be transmitted. 

Chairman COX. What is the source, Dr. Khan, for that information? Is that an input for you or is that something that you can develop yourself based on resources that you possess? 

Dr. KHAN. A lot of it was from input from our intelligence experts. Some of it is from—. 

Chairman COX. You say our intelligence experts, you mean? 

Dr. KHAN. Our civilian and military intelligence experts who provided input into the process of putting together the list. I promised 

a copy of all the individuals who participated in the—. 

Chairman COX. Does ‘‘our’’ refer to CDC? 

Dr. KHAN. No, I am sorry, the United States. 

Chairman COX. So those are outside inputs for CDC? Is the same 

true for NIAID? 

Dr. LAMONTAGNE. Absolutely. We don’t have any internal ability 

to do that kind of analysis 

Chairman COX. And then once you have those inputs and you are 

taking that information and running with it, do you then go back 
30

to those sources with the question of how might these agents be 

weaponized and dispersed? 

Dr. KHAN. That information was used in deriving the list. And 

we took into account the worst case scenario, which would be that 

these agents would be well produced and distributed by large particle aerosols. And then when you integrate that in with what we 

know about the morbidity and mortality, then you get a set of 

agents, the seven that we have mentioned, that would likely cause 

the most public health impact given all the right conditions for how 

the agent is manufactured, produced and distributed. 

So that list is not just the most lethal diseases because if you put 

a list together of what the most lethal diseases is you would start 

with rabies potentially at the top and Ebola and HIV and other diseases before you would get down to the seven that we are talking 

about. So it is more than just what is likely to kill you, it is what 

is likely to be produced and manufactured, what is their data and 

that if it is disseminated deliberately would cause a lot of public 

health damage. 

Chairman COX. Dr. LaMontagne. 

Dr. LAMONTAGNE. I would agree with what Ali has said but I 

also would comment that, yes, if we need additional information 

about whether some agent can be weaponized and how, we would 

have to ask for advice or information or input from the intelligence 

agencies. That is the only way we would know how to get that information. We have done that. I mean, they do communicate with 

us on these issues as well. 

Chairman COX. I think that my time has expired and I look forward to pursuing this line of questioning further. I believe that the 

gentleman from New Jersey, Mr. Andrews, is next to ask questions. 

Mr. ANDREWS. Thank you, Mr. Chairman. I would like to thank 

the witnesses and follow up on the chairman’s line of questions 

about inputs from intelligence sources and then outputs from your 

research work and management work to other groups. I assume 

that if they have not already done so, that terrorist organizations 

and enemy states are going to gain some knowledge of our vaccine 

potential or treatment potential and begin efforts to alter bacterial 

agents in a way that would defeat those vaccine efforts. I think it 

is a fair assumption that someone is going to try to do that. 

How would you find out that such an effort to alter had taken 

place? Would you have to ask the intelligence agencies or is it your 

experience that they would volunteer that information to you? 

Dr. KHAN. If I could defer this question to our current director 

of the CDC program who deals with these agents. 

Mr. HENDERSON. Thank you. Basically we do have some—. 

Chairman COX. I am sorry. Excuse me, sir. As you prepare to answer this question could you identify yourself for the record? 

Mr. HENDERSON. My name is Joe Henderson. I am the Associate 

Director for CDC’s Terrorism Preparedness and Emergency Response Program. We do have a scientific capability to look at organisms that we fear may have been genetically manipulated. One of 

the first tests we did with the anthrax events of 2001 was determine its antibiotic susceptibility. If we see that the organism is not 

susceptible to those antibiotics that it normally would be susceptible to, we would be suspicious. Then we have other laboratory 
31

tests working with the NIH and the military to determine if in fact 

we could tell with some certainty that an organism has in fact been 

manipulated. 

Mr. ANDREWS. Let me use this example. Let’s assume that our 

Intelligence Community discovered research being done on a new 

strain of synthetic anthrax and they had some information about 

that. It was taking place somewhere else in the world. What procedure exists for them to brief and notify you about that so you can 

begin to reassess your matrix of threats that you have to address? 

Mr. HENDERSON. I would say that prior to September 11th, 2001 

it virtually didn’t exist. Since then I think our ability to work with 

the Intelligence Community has improved considerably. For example, if we were to hear about—if there was in fact known intelligence that either the CIA or the FBI or the National Security 

Council or even DOD’s intelligence arm found to be credible they 

clearly would work through the Department of Health and Human 

Services through—the structure we use is through the Secretary’s 

command center to communicate to CDC this known threat. This 

has happened several times, most recently prior to the war with 

Iraq where we were concerned about retaliation. 

Mr. ANDREWS. I appreciate the answer. Mr. Chairman, what I 

find instructive about the answer, which is entirely candid and accurate, is that the Department of Homeland Security never 

emerged anywhere in the answer to the question, which I think 

tells us something about the intelligence problem that we have, not 

you. 

Second question is about outputs from research. I assume that 

if you are successful in identifying the—I may not pronounce this 

correctly—nucleic acid sequences of some of the biological agents, 

that that research might also have some usefulness or viability in 

the technology of detection. I assume right now it is impossible to 

know that someone is bringing in a vial of smallpox in a suitcase 

through an airport. It would be impossible to screen and identify 

that in any kind of technological way. I assume, though, that the 

more you learn about the makeup of these biological agents the 

more possibilities there are for research to detect the presence of 

the particular characteristics of these agents so they could be 

screened, they could be detected, they could be prevented from 

being brought into the country. 

What mechanism exists for to you share the research that you 

have done at NIH about the makeup of these agents with others 

that might use that research for purposes other than creating vaccines but, for example, for purposes of creating detection technology 

that might detect the presence of such agents? 

Dr. LAMONTAGNE. Well, I think we use a lot of traditional methods for that kind of transmission of information. Meetings, workshops, publications, are very commonly used for that purpose, and 

I think we would exploit all of them to try to get that moving into 

that direction. 

Mr. ANDREWS. Here again I think it is interesting that what we 

need is some kind of institutionalized connection between your 

agency and the Department of Homeland Security since if such a 

technological gain were possible, and it isn’t today, but if it became 

possible we would want to see an institutionalized mechanism 
32

where you would report that information to the DHS so they could 

begin the practical application research to do something with it. I 

offer no fault or criticism of you. I think it shows a disconnect in 

the structure that we have created that could fully exploit the research that you are doing. 

I see my time is up, Mr. Chairman. Thank you. 

Chairman COX. Thank the gentleman. The gentleman from California, Chairman of the Armed Services Committee, Mr. Hunter, is 

recognized for 5 minutes. 

Mr. HUNTER. Thank you, Mr. Chairman. I want to thank my colleague from Texas here for letting me take the next question. Gentlemen, it looks to me like we have been looking at this from the 

defense aspect. At some point we have to have in place a mechanism that would have maybe four parts to it: First, the ability to 

detect bad stuff quickly; secondly, the ability to analyze that stuff; 

thirdly, the abilities to quickly fabricate vaccines; and lastly, the 

ability to vaccinate the people who might be victims of that, whether it is uniform folks or folks in the population. And bringing into 

focus or focusing all this weight of talent that we have spread out 

across our institutes, our educational system, our private sector 

and the elements that are in DOD, bringing them, the weight of 

that talent into focus against those four elements that I just laid 

out looks like is a major challenge. And so maybe we are going to 

have two types of programs that we have to run. One is for what 

I would call anticipated problems and those are the major threats 

that you have listed in your categorization from A in descending 

order, things that we know are out there and that we are going to 

have to deal with but, secondly, the ability to deal with unanticipated stuff. 

So I would like to ask you your thoughts on whether you think 

we can do this, knit together a mechanism that can rapidly—and 

I think the key here is time is going to be of the essence—rapidly 

detect, analyze, fabricate inoculation or a medicine that will handle 

this particular problem and, lastly, protect our folks; that is, get 

the inoculations to them. You think we are going to be able to draw 

together from all these disparate elements this capability? 

Dr. KHAN. Let me talk to the first two elements of that. 

Mr. HUNTER. Pull that thing up close because I have trouble 

hearing. I would rather have you louder than softer in here. 

Dr. KHAN. The detection and analysis part is very much a function of what we do domestically with our State and local health departments working with CDC to try to figure out what new diseases or emerging diseases may be out there, quickly figure out 

that that disease is out there, find the agent, characterize the 

agent, and then move to step three, which is your step about fabricating vaccines, et cetera. That also works in the international 

arena. 

Let me just use SARS as an example of how that worked. Working with WHO, we discovered that there was a new disease out 

there which had never previously seemed to have been described 

as causing a lot of infection among health care workers who were 

dying. It was mainly focused in the health care setting. Working 

with our partners in WHO, and that meant putting staff out there 

in countries, we got hold of this agent, uncharacterized, brought it 
33

into the agency, quickly were able to isolate it and identify that 

this was a brand-new virus which was a type of corona virus, sequence the agent within weeks to help develop diagnostic tests. 

Now part of that process was that we shared what materials we 

got with NIH and other members in the private community and 

academic community and said, look, this is what we have, this 

looks like it may be a new corona virus. Can you help us develop 

diagnostic tests, can you help us develop new countermeasures 

against these agents? That happened extremely fast in this case. 

We would like that to be a model of how we look at not just new 

and emerging infectious diseases, but BT is part of that broader 

pallet of emerging infectious diseases that if somebody did release 

something like anthrax or plague that quickly that identification 

would occur in the local and public health departments, that agent 

would be very quickly characterized to say we have looked at the 

genes, none of these genes have been swapped, it doesn’t look like 

it is abnormal or it does look like it is abnormal, there seems to 

be new genetic markers in there, it seems to be resistant to everything, why is that, that shouldn’t happen naturally, and then move 

it to the next step with NIH to get us forward from there. 

Dr. LAMONTAGNE. I think I would add to what Ali has said, Mr. 

Hunter, that actually in the field of infectious diseases there is actually a lot of communication among investigators out there. There 

has also been historically—I have been at the NIH for 27 years—

a lot of very positive interactions between DOD agencies and CDC 

and NIH on many, many of these issues. So we have a track record 

of really sorting through these problems, I think, pretty effectively. 

The latter two points that you made in terms of developing the 

vaccines or countermeasures and actually deploying them effectively are really formidable challenges though that require considerable amount of investment in research and in infrastructure to 

accomplish successfully. I think that that is one of the areas that 

we really need to work most actively on because it is the most difficult. 

Dr. KHAN. If I could pick up from number 3 and 4 from John to 

go to 4, which is you get the vaccine but that is only partway there. 

You have to get it into people’s arms or the drug, you have to get 

it into somebody’s body. Then you have to monitor for the side effects, you have to maintain registries of those people. And that applied public health research is where CDC comes back into the picture to say, okay, there is actually some public health research involved in that part of the process. There was obviously research involved in the first part, the surveillance methodologies. The diagnostic methods we have out there didn’t come de novo. It took a 

lot of work and research to say these are the best strategies to find 

out what is going on, these are the best diagnostic tests. So research infuses the whole process. 

Chairman COX. Does the gentleman have further questions? 

Mr. HUNTER. No, Mr. Chairman. I appreciate it. 

Chairman COX. The gentlelady from Missouri, Ms. McCarthy, is 

recognized for 5 minutes. 

Ms. MCCARTHY. Thank you, Mr. Chairman. Thank you for your 

thoughtful presentation as well as your thoughtful responses to the 

committee’s questions. I would like you to elaborate a little bit. 
34

When Ms. Dunn was inquiring you talked with us about how the 

agencies have been coming together to work with you. But I wonder if you would expand a little bit on how the Intelligence Community is helping you assess what biological issues are priorities 

for us so that we can further direct you not only in your research 

but in your ability to help our local responders and communities 

all over America be adequately prepared. 

When I visit with my local responders out in the heart of America, their biggest fear is that they do not have the means to both 

coordinate with the hospitals and emergency centers in the case of 

a biological incidence but that even if there are drugs or other materials available that they won’t have them or the ability to disseminate them. While I know that you are primarily involved in 

the research end of this, please know that whatever comfort you 

can bring in your work to those on the front line 24/7 would be of 

great help to us and to our work and how we might better serve 

you in accomplishing that goal. 

Dr. KHAN. If you would permit, let me ask that question of the 

current Director of our CDC Bioterrorism Program, who deals with 

these local and State preparedness needs all the time. 

Mr. HENDERSON. Thank you, Dr. Khan. Excellent question, two 

parts of your question I see. One is how do we take the intelligence 

that we are currently getting at CDC and then translating that 

down to our State and local colleagues. I do want to mention a bit 

about our grant program from CDC that as at the end of August 

of this year we will have funded $2 billion to State and local health 

agencies, which has been a huge infusion into the public health 

system to assure they can in fact respond to these terrorism events. 

The intel piece, the challenge for us at CDC and the Department 

of Health and Human Services is the fact that our method of looking at information and data to determine how it might trigger an 

outbreak of an infectious disease or some other type of public 

health emergency is different than what the Intelligence Community does to analyze intel that comes in. We basically in public 

health like to investigate every possible event that could lead towards some type of illness, injury, death, even if it only affects one 

person. Intel we are finding out and becoming more knowledgeable 

about this process and gathering information from the Intelligence 

Community is a bit more of an art than a science we are finding, 

and it is difficult for us to really weed through all that to find out 

what in fact is credible information that needs to be relayed to the 

State and local law enforcement officials and public health so we 

can have a unified response in addressing the threat. 

So we continue to work on that to try to improve that. But again 

since September 11th we have done a lot with our health alert network to disseminate information to State and local health colleagues and through governors’ offices and State emergency management officials so that they are constantly aware of what we find 

throughout the Nation and globally that they need to know about 

that could potentially impact and affect their populations. 

The grant program we always say at CDC and with our colleagues at the National Association of County and City Health Officials that all response is local. We know that. For a terrorism event 

we know that regardless of the event the first 48 hours is going to 
35

fall on the backs of State and local, really the local public health 

officials to respond effectively to mitigate the consequences and recover from that event. 

We are building capacities at all levels. We know we need to continue to focus on the local level. Our grant program looks for meaningful collaboration between State and local health officials to ensure they have that capacity. We will continue to improve this program to assure we see that local response capacity. 

Ms. MCCARTHY. I thank you for that information and would like 

to suggest that if we on this committee can be of further assistance 

to you in reaching that goal you just described of adequately preparing our local first responders you must make us aware of that 

so we can be your advocates in the Congress. I know that my community—I have the greater Kansas City area on the Missouri side 

and suburbs—did receive a homeland security grant recently for 

training and equipment for our local emergency responders. For example, in Independence, Missouri, Harry Truman’s hometown, my 

police chief, my fire chief can’t communicate with each other. 

Equipment doesn’t talk to each other. When we had the tornado incidents recently they used their cell phones for as long as they 

could before those went out in order to meet the needs of the community and the surrounding communities. So you know, that grant 

money is helpful but still not enough. And I am thinking $2 billion, 

I applaud you for that on the efforts to help our first responders 

on the bioterrorism aspect of it, but I would like to say that that 

is not enough money either for what is needed locally all over this 

country. And we need to be sure we educate everyone to the fact 

that you know we aren’t going to leave them out there with great 

expectations but without the means to carry out their work. They 

want to do what is right. They are training and preparing to do so 

and we at the Federal level must be willing to help be that partner. 

So to the degree you can continue to advocate among the executive branch for better funding, for full funding, for adequate funding to carry out the goals you have established through your research and your intelligence and your work, then we can all be 

partners in seeing that the people’s needs are met in a crisis anywhere in America. Let’s hope that we never need to, but I do know 

that it is a very real concern out there in the heart of America, I 

would expect in all the communities represented here today on the 

committee. 

And I want to, Dr. Khan, thank you for your work with the intel 

officials that you have been meeting with and continue to do so, 

please, because it is critical that we all have the best information 

possible and to the degree that we can anticipate and be prepared 

the public will be better served. 

Mr. Chairman, I would like to yield back the rest of my time. I 

thank the witnesses and experts here today for responding to my 

questions. 

Chairman COX. Thank the gentlelady. The gentleman from 

Texas, Mr. Sessions, is recognized for 5 minutes. 

Mr. SESSIONS. Thank you, Mr. Chairman. I don’t know who to direct this to on the panel, but I am sure each of you would have an 

opportunity to make a comment. I believe as a result of precaution 

in the last few months we have gone about inoculating first re-
36

sponders, nurses, doctors, other people in the community who 

would come upon a potential of smallpox. A lot of people were given 

the inoculation. And I am interested in hearing from you about 

how that worked, lessons learned, things about not only giving the 

vaccination but people receiving it, whether it was based upon a 

threat, whether it was based upon, you know, just the best information that we had. I am interested in an evaluation of how that 

process went and has taken place because—and whether it was an 

actual threat or whether it was just something we did as a precaution. 

Mr. HENDERSON. Sir, I will take that question since at CDC it 

is my primary responsibility to manage the National Smallpox Program. It has been since August of last year. We have been very involved with working with our State and local colleagues on this 

issue. So I can touch on several aspects of your question. 

One, I want to mention the smallpox preparedness activity. You 

seem to indicate in your question as though we have done something and we are done with it and now we are looking back to see 

whether or not we have actually succeeded. I have to say that from 

CDC’s perspective we have done an awful lot in the past 8 to 10 

months in improving overall focus on smallpox preparedness, which 

is more than just offering the opportunity to vaccinate individuals. 

It is also a focus on assuring there are plans and employees that 

should you see a case of smallpox in your emergency department 

you can mobilize your resources to investigate that case, confirm 

that it is in fact smallpox disease, isolate that patient, hopefully 

minimize the spread. Those plans a year ago today, 10 months ago 

today, frankly weren’t in place. They are in place now. 

Also having plans in place to assure you can protect your population that hadn’t really been exposed yet if you see disease in your 

community through mass vaccination campaigns. Those are extremely labor intensive plans that require a lot of thinking, a lot 

of partnering at the State and local level with a whole variety of 

stakeholders. Those plans are in place now. They weren’t a year 

ago today. 

So even though there has been this focus on smallpox vaccination 

there has been a much more broader focus on smallpox preparedness in general. 

I have to say that the vaccine program itself has been relatively 

successful because we have people vaccinated now that we will call 

upon to evaluate those first cases of disease in the emergency department and to be called upon to investigate cases of disease in 

the community through our public health system. It is not the 

numbers that we had planned for initially but it doesn’t make the 

program a failure. We think it still makes the program a success 

because we have over 270,000 doses of vaccine forward deployed 

that should we see a case of smallpox we have people who are 

trained to vaccinate, we have clinics set up to vaccinate people, to 

screen them appropriately to assure we are not putting people in 

harm’s way who may be contraindicated. 

So overall we see this program as being a success. It is a success 

today and will continue to be a success as our State and local colleagues are now developing plans to focus on their supporting and 

maintaining smallpox preparedness into the future. 
37

Mr. SESSIONS. Well, I am glad to hear that it was a success. I 

think what you are saying to me was it was necessary to make 

sure we had a cadre of people who received the inoculation so that 

if they do come into contact or once it is recognized as smallpox is 

that, as Duncan Hunter said, that thing that is out there, that we 

are able to then have a group of people who are able to come into 

contact with those, and I think that is wise management. 

Secondly, I heard you say that you think it is at least reasonably 

successful, and that makes me happy. I think this is part of the 

preparedness that we are looking to CDC and this administration 

to be in those sorts of positions. 

I see my time is nearing an end. I would hope that at some point 

also we are able to have some discussion about—Dr. LaMontagne, 

you began to speak about it—but allowing the private sector once 

whatever this thing is that is identified but getting it to private 

sector companies, I am interested in knowing how we can more effectively unleash them so that bureaucratic rules, regulations do 

not hinder their ability to properly function. 

Dr. LAMONTAGNE. If I could comment briefly on this in relationship to the question on smallpox. We have actually been managing 

an effort that involves various agencies of the government, including CDC, FDA, USAMRIID and others, on the development of a 

next generation smallpox vaccine that is expected to be much safer. 

And that is a process that does engage the private sector and our 

approach in that process has been to generate milestone-driven initiatives where we will evaluate over a period of time how the private sector that we are providing resources to is actually performing against some standards. 

Mr. SESSIONS. Thank you. I thank our great chairman for his 

leadership in today’s wonderful meeting. 

Chairman COX. I thank the gentleman from Texas. The great 

gentlelady from Texas, Ms. Jackson-Lee, is recognized for 5 minutes. 

Ms. JACKSON-LEE. Thank you, Mr. Chairman. I will work with 

this microphone this morning again. I thank the witnesses very 

much and I appreciate the testimony that I had a chance to review 

and would like to raise several questions following the line of some 

of my colleagues, but specifically I want to acknowledge that all of 

us deal with the national security question but certainly must deal 

with the securing of our respective constituencies and the boundaries thereof. And in particular, I serve an urban area, Houston, 

Harris County, Harris County, one of the largest counties in the 

Nation, Houston, the fourth largest city in the Nation, extremely 

diverse, many individuals coming through for trade and other reasons and as well coming from all parts of the world to live in that 

community. So we have our respective challenge, but we have a 

very strong base of resources because we have the Texas Medical 

Center present, but also we have stakeholders like Riverside Hospital, which is a historically black hospital and we have the Lyndon 

Baines Johnson Public Hospital in the public hospital system that 

has a very large clientele, patient base, if you will, but not large 

enough. 

So I want to raise the question that I raised earlier in my opening statement and that has to do with the 40 million uninsured in-
38

dividuals in America, those that don’t have health coverage. I raise 

that because individuals who have health coverage are used to 

going to facilities, either have a physician relationship, used to 

knowing where a health facility or they know where a hospital is 

because they have a relationship there. What is the planned response if a situation arises where millions of people in an area 

need to go in for consultation, then inoculation, then follow-up and 

there are so many people without this good working relationship? 

How are aspects of your agencies looking at the questions of facilities to be in place for distribution that are not necessarily health 

facilities? Would be the follow-up with these facilities then continue 

or would you expect the normal public health system to assist? 

How will the resources be distributed to take this extra burden of 

people who don’t have a standing relationship and how will they 

know where to go? 

One of the questions that I have been raising with the—I have 

a homeland security task force in my community that I convene 

and I include institutions of learning, public school systems, as well 

as community groups because the question always becomes how 

will they be secure, how will they be apprised of the threat. So that 

is one question. 

The other question comes with accountability. Six billion dollar, 

part of the responsibility is of course to—I think the language is 

push and pull, push for vaccines to expedite research and pull by 

providing a market. What is the accountability of the pharmaceutical companies in terms of whether they will create the research, whether they will provide for the actual creation of the 

drug, what oversight do we have in doing that? 

My last question involves this whole issue. I think your testimony noted that there were certain bioterrorist entities or drugs—

not drugs but creations that we are aware of for at least diseases 

rather, smallpox, anthrax, plague and botulism as the top ones. 

What are we doing with respect to getting ahead of that? And how 

soon do we think, for example, smallpox will be available for everyone in the United States of America? 

Dr. LAMONTAGNE. Let me try to answer the question on the accountability issue, which I think is an important concern. I think 

there are a number of safeguards in the process that are nested in 

the regulatory process that we go through for drugs and vaccines 

that will ensure that whatever is available at the end of the day 

is satisfactory and meets the highest standards that we can achieve 

for a product to prevent or treat a disease. I don’t think there is 

any compromise in that at all. So we will—I am pretty sure that—

that is an important safeguard. In addition, I think the—as I mentioned, there is more of an attempt to use milestones, performance 

milestones in the award of these kinds of contracts to make sure 

that progress is at an appropriate level with the investment being 

made. 

Ms. JACKSON-LEE. The uninsured? 

Dr. KHAN. Let me answer that from the aspect of local preparedness. Your point is well taken and was actually one of the foundations of the Bioterrorism Program when it was laid out a couple 

years ago. All response, all detection occurs locally. Nobody from 

the Federal Government is going to come into your community and 
39

say, okay, I know where your hospitals are, I know where your 

gyms are, I know where your facilities are. This is where these people need to go. This is how this needs to get set up. All that preparedness has to occur locally. It is the local communities that will 

have to identify where their hospitals will be, where their facilities 

will be, what will be put up, what will be put down, and how they 

will try to integrate in the national resources as they come in for 

a response. And essentially the essence of our local preparedness 

and response program is to get those communities up and running 

with some guidance from the agency. 

So, again, it is the local response that we are all dependent on, 

all the Federal agencies that the local community is ready and 

knows if this pharmaceutical stockpile comes with 100 billion doses 

of X, how do we move it from this gigantic pallet into people’s 

mouths. It is again the local community. 

Ms. JACKSON-LEE. On the smallpox immunization, what efforts 

are we making to be able to immunize everyone in the United 

States? 

Mr. HENDERSON. Our plans right now are from the Department 

of Health and Human Services, looking at where we are in the clinical trials from the AKM products. First of all, I should mention 

we do have enough vaccine right now that should we have to vaccinate the entire population we can dilute existing quantities of 

vaccine to do that. But we are looking for the new product to be 

available in probably early to mid-2004. 

Ms. JACKSON-LEE. Let me just say thank you very much. Let me 

say, Mr. Chairman, I thank these witnesses very much. I want to 

make sure that the program of BioShield does not overlook small 

hospitals, small research centers, historically black colleges, Hispanic serving colleges where there are research elements, native 

American institutions. I just simply in closing would like to say 

that I would like someone to get with my office in particular about 

exposing these other, maybe other level entities about the research 

opportunities. 

Can I just conclude by saying is there any foreclosure precluding 

any of those kind of entities, smaller entities being involved in the 

research of research grants that are under your jurisdiction? 

Dr. LAMONTAGNE. Not at all. Actually we encourage that and are 

trying hard to reach out to that community as well. 

Dr. KHAN. Same at our agency. 

Ms. JACKSON-LEE. If I could encourage that and also, as was 

noted, these small and the local government areas, county health 

clinics and city health clinics, that we can work together to make 

sure that they are well informed and well involved. 

Thank you, Mr. Chairman. 

Chairman COX. The gentleman from North Carolina, Mr. 

Etheridge, is recognized for 5 minutes. 

Mr. ETHERIDGE. Thank you, Mr. Chairman. And again thank you 

for being here. Let me, Dr. Khan, go to you first if I may, please, 

sir. Obviously all of us are concerned as we talk the BioShield and 

the funds available here and it has been alluded to already and 

several have asked questions, but let me follow the question a little 

bit as it relates to districts because all of us represent different districts. Mine is one that has urban, suburban, rural, one large mili-
40

tary base and a small one. So it is a little unique and we have 

some of the large institutions. Most of our responders, first responders are volunteer, many of the areas as you can appreciate. 

You said in your prepared testimony that a strong and flexible 

public health infrastructure is the best defense against any disease 

outbreak. That being said, the four areas that I have talked about, 

the cities, the suburban areas, rural areas and the military, which 

one is the weakest link in our public health infrastructure and 

why? And what is the best way to address these weaknesses as we 

see them and, finally, which of these four areas is most vulnerable 

to attack? 

Dr. KHAN. They all, sir, have their own unique weaknesses from 

a public health standpoint. I can’t comment on the military, but we 

do know based on the anthrax attacks in 2001 that our civilian 

population, and a previous attack using a food borne agent, that 

our civilian populations are vulnerable to attack using biological 

agents. And I will go back to your comment about, I guess, what 

I originally started as my comment, is our agency’s comment about 

the public health system requiring to be flexible. 

Marcy Layton, who is the health director up in New York, is the 

first person to admit that her response to West Nile virus was better and was a more focused response because of her activities for 

bioterrorism preparedness. That is very much true if you look 

today at our response for SARS. Our response to this international 

outbreak is a lot better than it would have been based on our response to anthrax in 2001. 

So, again, the bioterrorism preparedness activities are helping to 

improve basic public health infrastructure. But we need to remember that the broader pallet of what we need to be doing is improving the ability not just for anthrax, which may or may not happen 

again, or smallpox, but there continues to be routine infectious diseases every day that need attention at the domestic level and also 

many diseases that need attention at the international level that 

we need to stay engaged in. And within that milieu we will then 

find out about these new diseases. But if we don’t stay engaged in 

what is going on every day, we will never fine anything new because we are having trouble finding the old stuff and taking care 

of it. 

Mr. ETHERIDGE. You don’t want to identify the weakest link in 

each one, because each one has their weak links. The reason I raise 

that question is because a lot of our States right now are really 

pressed, a lot of our health facilities are woefully inadequate and, 

to be very candid, because of the number of years we haven’t done 

the funding. I think as we look at this whole issue of BioShield the 

weakest link is where we have the greatest problem and we have 

to be prepared for that. 

Mr. HENDERSON. Can I just follow up on that and add a couple 

of things? You hit on a very important question, one that drives us 

in looking at our State and local program, as far as people ask us 

all the time are we prepared, who is prepared, who is not prepared, 

et cetera. It is a really difficult question to answer. There are three 

things that we see that impact the success criteria. One is political 

will. The second is leadership. And the third is resources. We have 

seen local jurisdictions with very little resources but strong leader-
41

ship and political will that have done amazing things. We have 

seen some jurisdictions with a lot of resources, but don’t have the 

political will, are struggling with leadership and they are probably 

not as far along as their citizens would like them to be. 

It is trying to find ways to combine those three strengths so we 

can assure we have a network of systems across the country that 

can in fact prepare and respond to these events. That is what we 

are doing in developing our evaluation criteria for our State and 

local cooperative agreements, is to provide the standards to assure 

we can develop those three success criteria so we can improve preparedness. 

Mr. ETHERIDGE. Thank you. Let me go very quickly to the next 

question because you testified, Dr. LaMontagne, about the 30 percent increase in the number of grant applications to develop bioterrorism countermeasures. With the existing personnel you now have 

and the resources, are you able to keep up with the application in 

grants and are most of them applications for basic research or are 

they actually for development of vaccines and other countermeasures? And, finally, do you believe that the BioShield funding 

is absolutely critical to the development of the most dangerous 

countermeasures? 

Dr. LAMONTAGNE. The question is a very important one, Mr. 

Etheridge. I think that—just to give you an analysis of the response that we have received—it is across the board. It is not only 

basic research which we have encouraged, but also we encouraged 

programs in very targeted and focused initiatives to try to generate 

the kind of vaccine or drug that we would like to have for a particular disease. One can always use more resources. That is always 

true, as you know. But I think it is moving along pretty well. So 

we will see how this evens up in the next year or so, I think. We 

will have a better indication of how well we have titrated our own 

resources with what is coming in. 

Chairman COX. Thank the gentleman. 

The gentleman from Rhode Island, Mr. Langevin, is recognized 

for 5 minutes. 

Mr. LANGEVIN. Thank you, Mr. Chairman. Again thank you for 

your testimony today, gentlemen. It has been very enlightening 

and informative. I guess I would start off by saying that clearly 

what we need to do and various aspects of government need to do 

is inspire confidence in this question and, more importantly, inspire confidence in the minds of the public that there is a coordinated and comprehensive process and effort that exists with respect to dealing with bioterrorism and the threat of bioterrorism. 

I don’t think that we are there yet. I don’t think that in the mind 

of the public that we can say that we have inspired that level of 

confidence. I think CDC and NIH are off to a very good start. I 

think that is one of the bright spots in this whole effort. But we 

clearly have more work to do. 

I would like to turn to the line of questioning that the chairman 

had started with in dealing with how you are getting your information and intelligence. Clearly identifying the pathogens, for example, that NIAID should be working on depends on assessments of 

the bioterrorism threat. And I am curious to know, in exploring 

again the chairman’s line of questioning, the level of interaction 
42

that you are having with the intelligence communities. In particular, it sounds like this is more of an informal process than a 

formal process. So I would like to you explain that interaction a little more thoroughly if you could. 

And also, I would like to know where the Intelligence Community is deriving its data set; for example, where are they getting 

their intelligence? And are you dealing with peers within the Intelligence Community when you are talking to these individuals or 

are they lay people? 

And also, since DHS is going to have a major role in this process, 

I would like to know if DHS has contacted either CDC or NIH to 

ask for your input as they are setting up their internal structure 

for dealing with the bioterror threat? 

Dr. KHAN. That question, sir, let me turn that again to Mr. Henderson, who deals with our current day-to-day programming. 

Mr. HENDERSON. Just again reflects on the intelligence and formalizing the process. I should say that for my particular agency, 

just to be selfish for a moment, we would love to have a one-stop 

shop where all the intel is coming in, they are analyzing it and 

they are handing us stuff and they find it to be credible that they 

are looking for us and our State and local colleagues to respond to. 

Right now, that is in fact the concept of homeland security and we 

are working with them in trying to decide how best to do that. We 

still though have our peer relationships and contacts in the agencies I mentioned earlier, the NFC and the CIA and the FBI. We 

actually at CDC have an FBI analyst who is stationed at CDC to 

help us with any potential threats that may be coming into CDC 

as a facility since we managed to secure select agents, and so that 

is a sea change in thinking in how we dealt with this prior to September 11. The only way that happened was through a coordinated 

approach working with the Department of Homeland Security. 

I also want to mention that in formalizing this arrangement with 

Homeland Security to understand how we will take this intelligence and respond appropriately, and accurately, it played out 

pretty well in the TOPOFF II exercise where we were looking at 

plague in Chicago and a dirty bomb scenario in Seattle. We saw 

through that exercise scenario how the future will look as far as 

how CDC will get information that we will act upon, and we liked 

what we saw. It made sense to us. It was logical. We could react 

faster and we had a higher degree of confidence in the information 

that was coming to us. Again that was a scenario that was artificial. But it showed us what the future held and I have to say that 

Homeland Security played a strong role in that activity. 

Mr. LANGEVIN. And they are reaching out to you and asking for 

your input as to how they should set up their internal infrastructure with respect to bioterrorism? 

Mr. HENDERSON. Yes, they have asked us because you have to 

remember it’s not a one-way street. As much as they are going to 

give us intelligence information they are looking for CDC to also 

provide them intelligence information. And SARS is a good example. We have people over the globe we are working with and as we 

collect all the information the only way for them to get it is 

through CDC. So it does open a two-way channel of sharing of information. 
43

Dr. LAMONTAGNE. I would completely agree with what Joe has 

said. I mean I think we have experienced a sea change in our ability to interact and work with the intelligence agencies not only at 

the NIH, but obviously, as Joe has pointed out, with CDC, and I 

think the Department of Homeland Security and before it the Office of Homeland Security have been very helpful in making sure 

that that conversation takes place. 

Mr. LANGEVIN. I see my time has expired, so I thank you for 

your—. 

Chairman COX. The gentleman from Florida, Mr. Meek, is recognized for 5 minutes. 

Mr. MEEK. Thank you, Mr. Chairman. I want to go back to some 

of the statements I made in the opening dealing with working with 

other countries, and I know that the Dutch have worked in many 

areas of research and have found, been discoverers of vaccines. I 

know that both agencies work with the international community as 

it relates to finding vaccines and sharing research information. I 

believe bioterrorism here—and there are three categories, A, B and 

C—is something that could be a reality in any city or small town. 

How are we working with those other countries that are out there 

that may be facing some of the same threats that we are facing? 

And the reason why I am asking the question, the fact that I think 

that we would see some activity abroad maybe not here in the 

homeland, but we would see activity abroad first and then we can 

pretty much expect that that is just a test or the training area, just 

to bring a homeland attack here in the United States. 

Dr. KHAN. Thank you very much for that question, sir, and actually it is a major focus of what I do on a day-to-day basis these 

days. We have a number of activities in place internationally. So 

I am working with the World Health Organization directly and 

their smaller subsets of WHO. We have relationships with regions. 

We have relationships with specific countries to do various projects 

and systems. We have also set up something called international 

emerging infectious disease programs. We have one such program 

we would be delighted to expand that worldwide. These are areas 

where there are a couple of CDC specific people in country who 

help build up their surveillance capacities and their response capacities and it would allow the country to find what is going on, 

be it bioterrorism, other emerging diseases, a lot faster because 

that is truly what the delay is. 

You know, once the countries recognize it we generally have good 

relationships to get those agents to the United States and other 

countries for development of vaccines and diagnostics, but often the 

countries don’t have the ability to recognize what is going on in 

their own country, and that delay is deadly, especially for bioterrorism, because you may only have a couple of days to actually 

treat patients or get your set of countermeasures ready before the 

agent comes to you. So we would like to expand that international 

emerging infection program and it has been—let me give SARS as 

an example. 

Again this was not bioterrorism, but we had one of these programs in Thailand that provided us the opportunity to help Thailand, Taiwan, Cambodia and Laos based on this handful of people 
44

who were based out in Thailand, and it would have been nice to 

have done that in additional countries. 

Mr. MEEK. And, Dr. Khan, one of the other concerns or things 

that I think that we need to know if it is something that is going 

on somewhere in the globe that any of you on the panel may be 

very concerned about, that could potentially happen here in the 

United States as it relates to bioterrorism. And I can tell you right 

now, since 9/11 everyone is trying to focus on issues that you have 

been working on your entire careers. Now, all of a sudden you are 

front stage. Everyone wants to pay attention. But still when we 

start looking at local communities, States, they are also fighting for 

funding. They are fighting for the flexibility that is being asked for 

in this piece of legislation, and I think Americans as we look at legislation that has been passed through this Congress, PATRIOT Act 

I, with the potential PATRIOT Act II, and the misallocation or appropriation of that legislation, it set us back. And one, do you see 

an area in the country or in the—not in the country but in this 

world that because of your individuals that are out there from the 

CDC, something that potentially that is raising your eyebrows, 

something that we need to pay close attention in, something that 

you are right working with—what you have now to work with that 

you are moving in that direction to find a vaccine to make sure 

that it doesn’t become a problem for Americans? That is one. 

Two, as it relates to dissemination of a vaccine, if something was 

to happen here in the United States, do we have better functions 

in being able to get that vaccine and being able to make sure that 

we have enough of it to deal with a wide-scale bioterrorism activity? We have had several exercises or two or three recently. How 

did things turn out there as it relates to the response? 

Dr. LAMONTAGNE. I could start on one aspect of your question, 

Mr. Meek. I think that, yes, there are diseases that we are quite 

concerned about overseas that might come here. The one that I 

might mention that I have had a professional interest in for a long 

time is influenza. And as a matter of fact, we have a considerable 

interest in looking at influenza in many parts of the world, including the Far East, Hong Kong and China in particular, through 

projects that we have supported for surveillance of animal influenza viruses in the Hong Kong, area in particular. I think that 

was, as it turned out, that group, because of its enhanced capacities, I think it was quite helpful in dealing with the SARS outbreak that occurred recently. 

So, yes, we do have groups out there doing that kind of work all 

the time. 

Dr. KHAN. Let me follow up on those comments that we do have 

a number of people stationed overseas who look at emerging infectious diseases, and pandemic influenza is a major concern for us. 

Again the influenza outbreak of 1918 was the largest epidemic in 

the world, killed probably over three-quarters of a million Americans based on that population. And we know without a doubt pandemic influenza will happen again and we need to be prepared and 

the only way to be prepared is to have a presence overseas. 

So it is important and I think, Mr. Meek, this is where your 

question was coming from, it is important to maintain our focus 

internationally as we think about bioterrorism also. Because people 
45

may practice potentially outside the U.S. first, or for a disease that 

is spread by person-to-person transmission, there is no reason to 

start in the U.S. If it is spread by person-to-person transmission 

you put it anywhere in the world it will make it is way to the U.S., 

and there is numerous diseases that are examples of that. West 

Nile is an example of that. Wasn’t in the United States. SARS is 

an example of that. Wasn’t in the United States. We continue to 

get imported cases, 1,500 cases of malaria every year into the 

United States. 

So importations, translocations of disease are a common process. 

Another reason why we can’t forget the international arena for bioterrorism is you know John said they are trying to develop countermeasures, anthrax, plague, tularemia. There aren’t that many 

cases in the U.S.; however, there are such cases abroad and if we 

have good relationships with countries where these are still problems we would have a place to use our countermeasures. You know 

as we develop new smallpox vaccines if we have good relationships 

with countries where monkey pox is still an issue, potentially that 

could be a model that could be used for vaccines and therapeutics 

that would then prepare us domestically and help our counterparts 

internationally. 

Dr. LAMONTAGNE. Just to add to what Ali has said, in terms of 

the availability of the vaccine or the intervention that might be desired, I think there is still much work to do to make sure that we 

have adequate supplies of these vaccines, and I think that is where 

the complementarity associated with BioShield could be very helpful. 

Mr. MEEK. Mr. Chairman, I believe that when we start to move 

forth this legislation, not only communications, not only statutory 

direction to the departments, because we have a number of agencies and departments working together, what we find in the law 

enforcement community everyone talks about, oh, we are working 

together and they come here and they walk in the room hand in 

hand and hugging each other and then after they walk out the 

room, they don’t talk to one another. I call it bleacher democracy. 

I mean, they would be together only in a time that they need to 

be there. But communications is very, very important. And in the 

area that y’all are working in, this is front seat. To get vaccines, 

to be able to get preventive measures countermeasures out there 

in a timely manner with local health agencies, working with them, 

making them feel a part of what is going on is going to be key. I 

don’t know if we can legislate that. That is something that I think 

that works within the professional community of making sure that 

that happens. Anything to the end of helping us, well, anything to 

helping us in this legislation work with other nations that are ally 

nations that share a common threat, a common loss, it is very, very 

important and I think that we reflect that, and I am pleased to 

hear that you are out sharing and looking and trying to detect that 

information. Hopefully that is going across to the law enforcement 

segment of this effort against terrorism. 

Chairman COX. The distinguished gentlelady from the Virgin Islands, Dr. Christensen, is recognized for 5 minutes. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman, and I just want 

to start out by saying how much we appreciate both, all three of 
46

you being here and the work that you have been doing, as evidenced I am sure only in small part by your testimony and your 

responses. We want to make sure that you have the resources and 

the support to continue to do it and to improve upon it. 

I want to ask—my first question kind of piggybacks on the last 

one my colleague Mr. Langevin was asking, and it is one that has 

been asked before. There are coordinating councils, there seems to 

be a very good but informal working relationship between the different parts of the Department of Health and Human Services and 

the other agencies. Would it, as we look at the act and look towards 

some possible amendments, is there something that we ought to be 

doing to put all of this into one umbrella agency with one director? 

Would that improve, would that be an improvement over the relationship we have now? Would it be easier? Would the communication be better or do you feel that the way it is working now is working at its best, all of the research and development of countermeasure? 

Dr. LAMONTAGNE. Well, I think considering the fact that for 

many of us it is a new role, this I think actually works pretty well. 

And I am not sure that a new entity as such is really required. I 

think the big challenge for us, which is a comment that I think Joe 

alluded to in one of his responses a little while ago is that you are 

dealing with different cultural aspects to these different agencies, 

and I think developing ways in which we can communicate is going 

to be something that is perhaps iterative and takes a while. But 

I actually think that it is quite positive from my perspective. I don’t 

really have any reasons to complain. 

Mr. HENDERSON. I agree, John. One of the things I think that 

you are probably hearing on this particular committee, you probably heard it yesterday, you may be getting a sense of it today, is 

that it has only been 7 months since they passed the Homeland Security Act, and so 7 months employing this large organization, and 

we are working very hard with Homeland Security because we 

want to develop the right relationships. 

What are the right relationships? And you know where are we 

seeing the true leadership? Where are we seeing the resources in 

the political world that I mentioned before? What we are asking 

State and local health colleagues to consider we need to consider 

at the Federal level. I think if we give the current situation a 

chance and a little bit more time we will pull it together. But in 

the meantime there should be some confidence that we are engaging and we are developing these relationships. We can continue to 

improve communication, but we are working at doing that. I think 

hearings like this are very helpful to bring this to light for us to 

just remind us that we need to continue to make this investment 

in time and building relationships. 

Mrs. CHRISTENSEN. And apropos of the issue of time and the time 

it takes to do this right, and to get it where it needs to be, the Institute of Medicine has been asked to look at Project Bioscience to 

assess, investigate it and come up with some recommendations 

which won’t come out until later on this year. The recent interim 

report says that they really need more time because this is a very 

complex, bioscience is a very complex initiative and with far reaching implications. And I heard, and I read in your statement, Dr. 
47

Khan, something that I have asked many questions about in previous hearings, the importance of focusing on the public health system. We hear that there are laboratories still to be built, B–3, B–

4 laboratories still to be built. What is the danger in waiting until 

we—and especially given the fact that many of our hearings have 

not been as informative as this one. What is the danger in waiting 

until we get a very informed assessment of bioscience before moving ahead? Can’t we be doing more with our public health system, 

doing more with basic research, putting the facilities in place that 

we know need to be in place now? And wait until we get a report 

and do it right? 

Dr. LAMONTAGNE. Well, I think one danger would be—in my 

mind the fact that there are lots of things that are going on right 

now in the research arena, the sort of push thing that Dr. Fauci 

refers to. There is a big investment being made in this field. We 

are pushing research very aggressively to develop the vaccines and 

the drugs we need. We need to get the pull components. So that 

pull component is I think very important. It is a complement to the 

push. So the sooner that we can do that I think the more effective 

the program will be in its total capability. 

Mrs. CHRISTENSEN. That was the shortest 5 minutes I have ever 

seen, Mr. Chairman. 

Chairman COX. The gentlelady is recognized for an additional 2 

minutes. 

Mrs. CHRISTENSEN. Okay. Thank you. Thank you. Project BioShield—thank you, Mr. Chairman—presumes basic research being 

done, promising countermeasures being identified and then incentives being given as you just described. What is the status of the 

basic research? Do we have a lot of basic research done ready to 

go to the private sector to be taken to the final product? 

Dr. LAMONTAGNE. I think the short answer to that question is 

that it depends on the agent. In some cases we have very good 

basic information, for example, in anthrax. But for a lot of the 

other diseases that are in the Category A list, basic research has 

not been—they haven’t been easy to study so we don’t have a lot 

of basic information. We do need it in order to get the kinds of 

things that we will need at the end of the day. 

Mrs. CHRISTENSEN. And for those that you have the basic research ready to go, how—can it be done under the current processes? Even with the incentives, the private sector has some concern that they will spend significant amounts of their own money 

and not be able to put this on the private market. So can it be done 

now with what we have? 

Dr. LA MONTAGNE. Well, I think that is the dilemma. We can 

take it through the basic research and I am going to include in that 

some developmental research. We can do clinical trials perhaps and 

learn how to produce something in large amounts, and so forth, 

and have a very mature product. But the risk is that there won’t 

be anything, any entity, a corporate entity which—and they are 

really the ones where the expertise exists to produce vaccines and 

medications at high quality reliably in large amounts. And unless 

you have the capacity to basically hand it over to them in some effective way, you are not going to be able to get the material that 

you need in the amount you need. That is the risk. 
48

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. I appreciate the 

extra time. 

Chairman COX. I thank the gentlelady. Our witnesses, we do 

have additional questions for the panel. We’d like to let you go before noon if that is at all possible. You have been at the witness 

table for nearly 2.5 hours, and so I would invite you, unless you 

want to just press on, to stretch your legs and take a recess. But 

it is up to the panel. 

Dr. KHAN. We will press on, sir. 

Chairman COX. We could adjourn for 5 minutes and come back 

at 11:30 if that would work for you. We will recess for 5 minutes, 

and that I think would put us at 11:25. At 11:25 we will resume. 

[Recess.] 

Chairman COX. I would like to welcome our members and our 

witnesses back. Dr. Khan and Dr. LaMontagne, I hope you are 

ready for the second round of questions. We have four members 

present. We hope to be sparing of your time. You have been very 

generous with your time. I want to thank you once again, as I did 

at the outset, for being with us here today and for your outstanding 

assistance to this committee as we prepare to mark up legislation 

perhaps as early as next week to create the Project BioShield, a 

multibillion dollar program. 

The Chair would recognize himself for 5 minutes. Right off the 

bat, let me ask whether either of you have familiar with the program of the former Soviet Union, Biopreparat. Is either of you familiar with that? 

Dr. LAMONTAGNE. Yes, somewhat. 

Chairman COX. Dr. LaMontagne, Scott Becker, who is the Executive Director of the Association of Public Health Laboratories has 

stated, quote, we do not have a national plan or a lead agency for 

many of the laboratory activities. Did the U.S. have such a thing 

as Biopreparat? 

Dr. LAMONTAGNE. Well, I mean my understanding of the genesis 

and the purpose of Biopreparat was as an organization that was 

designed for the production of basically biological munitions, so I 

don’t see any need for us to be in that business necessarily. 

Chairman COX. But I am sorry. I mean only organizationally, a 

lead agency with overarching responsibility. I don’t mean to draw 

the analogy beyond that. 

Dr. LAMONTAGNE. I am really not sure whether we would need 

something quite like that. As I tried to illustrate in my responses 

to various questions through the morning, I think there is actually 

very good interaction and communication within the agencies that 

are responsible with this activity. There are entities such as the 

Homeland Security Council and other groups that are, I think, 

bringing together these agencies in a coordinated manner. So I am 

not sure that it is needed at this point. 

Chairman COX. Dr. Khan. 

Dr. KHAN. Let me specifically talk about Scott’s comments. There 

actually is a laboratory response network in the United States 

working with APHL, which is how we get diagnostic reagents out 

to all States and local health departments. And if you expand that 

laboratory response network one more step, you realize why it is 

difficult to take all terrorism response activities into a single entity 
49

1 Rotz, Lisa D., Khan, Ali S., Lillibridge, Scott R., Ostroff, Stephen M., and Hughes, James 

M., ‘‘Public health assessment of potential biological terrorism agents’’ Emerging Infectious Diseases, Volume 8, No.2, 225–230, February 2002, Centers for Disease Control and Prevention. 

from a public health standpoint because you can’t separate out the 

routine public health responsibilities from what potentially could 

be terrorism. Terrorism doesn’t wave a red flag saying hi, I happen 

to be anthrax. It is somebody walking in the emergency room short 

of breath who has a large middle of his chest on his chest x-ray 

and you look at the chest x-ray, you look at the symptoms and you 

go, okay, this may potentially be anthrax. Or somebody walking in 

with a rash and you need a clinician to say, no, I don’t think this 

is chicken pox, I actually think this potentially could be smallpox. 

So you can’t separate out those pieces of the public health response. They are an integrated public health response. And going 

back to the APHL and the relationship with the laboratory response network, this laboratory response network, it was originally 

set up specifically for bioterrorism purposes. It was set up to say 

these are the critical agents, these are the reagents and the tools 

you will be using to monitor for these agents. We just sent SARS 

reagents through that network. We have sent West Nile reagents 

through that network. It is too interconnected, it is extremely interconnected. 

Chairman COX. I want next to go to the report that you submitted with your testimony. Dr. Khan, you were one of the authors 

of this report which is summarized for us, titled ‘‘Public Health Assessment of Potential Biological Terrorism Agents.’’ 1 It describes 

how in June of 1999 experts got together to review general criteria 

for selecting the biological agents that pose the greatest threat to 

the population. 

Reading this, and then reading testimony that you provided 

today covering some of the same ground, it is not clear to me just 

how much classified information went into the preparation of this 

evaluation of this review. In the CDC report summary, it stated 

that the following unclassified documents containing potential biological threat agents were reviewed. The Select Agent Rule List, 

the Australian Group List, the Unclassified Military List, the Biological Weapons Convention List and the WHO Biological Weapons 

List. Participants with appropriate clearance levels reviewed intelligence information regarding classified suspected biological agent 

threats to civilian populations. No information was available about 

the likelihood for use of one biological agent over another. Because 

this assessment that we are after is meant to rank the threats according to materiality, I am in the dark about what classified information, if any, was directed towards the likelihood of these threats. 

Dr. KHAN. Sir, the list in the acknowledgment section are some 

of the participants and we have promised to provide the committee 

the specific names and the agencies CIA, FBI, National Security 

Council, et cetera, who participated in developing the list and did 

provide classified information in terms of what agents had been 

weaponized and mechanized for potential use. So that data was integrated into the final risk analysis matrix. 

Please recognize that the reason for the matrix was that we 

needed to try to get some of the information that may have been 

classified into an unclassified setting because that is the only way 
50

to prepare a public health and medical community. You can’t tell 

them there is something I can’t tell you that may be a problem. 

You have to tell them we think based on the risk matrix there are 

six or seven diseases we need to pay lots of attention to. Make sure 

you know their clinical signs. Make sure you have surveillance, 

make sure you have diagnostic tests. 

Chairman COX. I am just trying to understand the representation in both the testimony and the report summary that no information was available about the likelihood for use of one biological 

agent over another. So I am inferring from this that classified, unclassified or otherwise, there was no information, is that right? 

Dr. KHAN. At the time of that meeting we were not specifically 

provided information that said agent X is the likely agent. And the 

list, the way it is structured, is not a probability list. 

Chairman COX. Right. Now, June of 1999, that is when this was 

done, is that right? There was no information. Has this analysis, 

this ranking, or the composition of the list, been updated since 

1999? 

Dr. KHAN. Let me take that from one aspect and then I am going 

to turn it over to our current Director who deals with this on a dayto-day basis. The list, the set of the criteria was peer reviewed after 

1999 before publication in 2001 and to make sure those criteria 

were stable. 

Chairman COX. And does the peer review include the Intelligence 

Community? 

Dr. KHAN. No, sir. It includes the process to say that this is the 

right way to put together the list. 

Chairman COX. That is, the scientific community? 

Dr. KHAN. The scientific process to put together the list. And 

then since that time, and, Joe, maybe you can take the question 

from this point of our ongoing interactions with the Intelligence 

Community. 

Mr. HENDERSON. At this point we at CDC have to consider that 

this list is still viable and it is still a useful tool to provide our 

framework based upon the criteria. 

Chairman COX. Well, just pause right there. My question was 

whether it has been updated since 1999 and what I am hearing you 

say is that we have to still consider that it is applicable. 

Mr. HENDERSON. Yes, sir. It has not been changed since 1999.

SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER COX 

THE WASHINGTON TIMES

WWW.WASHINGTONTIMES.COM

CIA says al Qaeda ready to use nukes 

By Bill Gertz 

Published June 3, 2003

Al Qaeda terrorists and related groups are set to use chemical, biological and nuclear weapons in deadly strikes, according to a new CIA report. 

‘‘Al Qaeda’s goal is the use of[ chemical, biological, radiological or nuclear weapons] to cause mass casualties,’’ the CIA stated in an internal report produced last 

month. 

‘‘However, most attacks by the group—and especially by associated extremists 

probably will be small-scale, incorporating relatively crude delivery means and easily produced or obtained chemicals, toxins or radiological substances,’’ the report 

said. 
51

Islamist extremists linked to al Qaeda leader Osama bin Laden ‘‘have a wide variety of potential agents and delivery means to choose from for chemical, biological 

and radiological or nuclear (CBRN) attacks,’’ said the four-page report titled ‘‘Terrorist CBRN: Materials and Effects.’’

The unclassified report was produced by the CIA’s intelligence directorate, and a 

copy of it was obtained by The Washington Times. 

The report identifies several deadly toxins and chemicals that al Qaeda could use 

to conduct the attacks, including nerve gases, germ and toxin weapons anthrax and 

ricin, and radiological dispersal devices, also known as ‘‘dirty bombs.’’

Disclosure of the CIA report comes as the agency is under fire over its reports 

on Iraq’s chemical, biological and nuclear weapons, none of which has been uncovered. Several lawmakers from both parties, including Sens. John W. Warner, Virginia Republican, and John McCain, Arizona Republican, have called for hearings 

into the intelligence about Iraq that the Bush administration received. 

In the latest report, the CIA said terrorist success would depend on planners’ 

technical expertise. However, one likely goal of any attempted attack would be 

‘‘panic and disruption,’’ the agency stated. 

Several groups of al Qaeda tried to conduct ‘‘poison plot’’ attacks in Europe using 

chemicals and toxins in assassinations and small-scale attacks, the CIA said. 

‘‘These agents could cause hundreds of casualties and widespread panic if used 

in multiple, simultaneous attacks,’’ the report said. 

Also, al Qaeda is developing bombs with radioactive material from industrial or 

medical facilities, and an al Qaeda document obtained in Afghanistan revealed that 

the group had sketched out a crude device capable of causing a nuclear blast, the 

report said. 

‘‘Osama bin Laden’s operatives may try to launch conventional attacks against the 

nuclear industrial infrastructure of the United States in a bid to cause contamination, disruption and terror,’’ the report stated. 

Al Qaeda’s plans for chemical arms were revealed in a document obtained in summer 2002 that ‘‘indicates the group has crude procedures for making mustard agent, 

sarin and VX,’’ the report said. 

Mustard is a blistering agent, and sarin and VX are nerve agents that can kill 

humans in small amounts. 

The report also states that Mohamed Atta, ringleader of the September II attacks, 

and Zacarias Moussaoui, who is on trial in Virginia on charges related to the attacks on the World Trade Center and Pentagon, studied methods of delivering biological weapons. 

Both men ‘‘expressed interest in crop dusters, raising our concern that al Qaeda 

has considered using aircraft to disseminate [biological warfare] agents,’’ the report 

said. 

According to the report, al Qaeda and other terrorists also could produce what the 

CIA calls an ‘‘improvised nuclear device’’ capable of causing a nuclear blast. 

Such a bomb is ‘‘intended to cause a yield-producing nuclear explosion,’’ the report 

said. 

Terrorists could produce a nuclear device in three ways, including a bomb made 

trom ‘‘diverted nuclear-weapons components,’’ a nuclear weapon that had been modified, or a new, indigenously designed device, the report said. 

A homemade nuclear bomb would be one of two types: either an implosion device 

that uses conventional explosives to create a nuclear blast, or a ‘‘gun-assembled’’ device. Making a nuclear bomb would require that terrorists first obtain fissile material such as enriched uranium or plutonium as fuel for creating a nuclear blast. 

A more likely type of terrorist attack is the use of such nuclear material with conventional explosives to create a ‘‘dirty,’’ or radiological, bomb, the report said. 

‘‘Use of a [radiological dispersal device] by terrorists could result in health, environmental and economic effects as well as political and social effects,’’ the report 

said. ‘‘It will cause fear, injury, and possibly lead to levels of contamination requiring costly and time-consuming cleanup efforts.’’

Among the materials that are available to terrorists for this type of bomb are cesium–137, strontium–90 and cobalt–60—materials used in hospitals, universities, 

factories, construction companies and laboratories. 

A security notice made public by the State Department yesterday stated that ‘‘al 

Qaeda and sympathetic terrorists groups continue to demonstrate their interest in 

mass-casualty attacks using chemical, biological, radiological, and nuclear (CBRN) 

weapons.’’

The notice said no information proves the group now is planning an attack in the 

United States with a weapon of mass destruction, but noted that ‘‘such an attack 

cannot be ruled out.’’
52

The FBI also distributed a bulletin recently to law-enforcement agencies identifying the chemical, biological and nuclear weapons available to al Qaeda and other 

terrorists. 

The CIA report contains photographs of a training video obtained in Afghanistan 

from an al Qaeda training camp showing chemical agents being tested on dogs. 

Agents available to the group include toxic cyanides that can kill in high doses 

and less lethal industrial chemicals such as chlorine and phosgene. 

Biological agents al Qaeda could use include anthrax, a bacteria that can cause 

mass casualties, and botulinum toxin. The CIA stated that methods for producing 

botulinum have been found in terrorist training manuals. 

Another toxin weapon, ricin, ‘‘is readily available by extraction from common castor beans,’’ the report said. 

‘‘There is no treatment for ricin poisoning after [the toxin] has entered the bloodstream,’’ the report said. ‘‘Terrorists have looked at delivering ricin in foods and as 

a contact poison, although we have no scientific data to indicate that ricin can penetrate intact skin.’’  2003 News World Communications. Inc. All rights reserved.

Chairman COX. It has not been changed since 1999. There is a 

report that was referenced in the newspaper on June 3 from the 

CIA titled ‘‘Terrorist CBRN Materials and Effects. ’’ That includes 

a report that al Qaeda terrorist and related groups are said to use 

chemical, biological and nuclear weapons in deadly strikes. Quote, 

Biological agents al Qaeda could use include, and then they are 

listed. Now this is obviously more recent. The list that you are 

working off of dates 2 years before 9/11. Is that right? 

Mr. HENDERSON. Yes, sir. 

Chairman COX. And even then at the time it did not include information concerning the likelihood for use of one biological agent 

over another. The reason I ask this question and I am pursuing 

this line of inquiry is that in the legislation that we are considering 

right now the Secretary of Homeland Security is going to be responsible for making this ranking. He is going to be responsible for 

doing it on an ongoing basis and a current basis and we are trying 

to understand what facility, what resources are available to the Department and to the Secretary to accomplish this. Based on our 

joint subcommittee hearings of yesterday, I think it is very clear 

that this capacity does not exist in the Information Analysis Directorate and that we have to go outside for it, and so we are becoming intensely interested in how this process is working with you 

and the Intelligence Community and in any way that we can we 

want to make sure that you have opportunities to be current, to get 

the intelligence that you need, and to adjust the science accordingly. 

So since my time has expired I will just leave you with this question. We are in fact moving forward on marking up this legislation. 

What could we do in this legislation to improve your life, to improve your capacity to do these things? So, for example, you are no 

longer working off a 1999 list. I would address that to any of the 

three of you. 

Mr. HENDERSON. I will start and I am sure John has a comment. 

One thing I would recommend is that when we make a decision to 

include something on the list, whatever the disease is and how the 

disease is transmitted, understand that provides a framework for 

a whole variety of other decisions that then have to be made at the 

State and local level, the Federal level, et cetera, including for us 

and the Department of Homeland Security the formulary for the 

strategic national stockpile. We know we need to have a routine re-
53

view, whether it is annual or every 2 years, of the formulary for 

the stockpile and that is all based upon what we consider to be 

those agents where there is a higher likelihood that they could potentially be used by terrorist organizations. There is nothing right 

now that mandates the review by any form of a committee. So if 

you were to recommend something that could be seen as very helpful for us in pulling together all the resources that we would look 

at as being our scientific and law enforcement advisory body that 

could help advise on what we need to do with our programs to 

stockpile, et cetera. 

Chairman COX. Well, the legislation does mandate an ongoing review, and it places that responsibility with the Secretary of Homeland Security. But it is very abstract about how in the world this 

is going to be accomplished and since it is going to be apparently 

accomplished with a great deal of outside resources, I think we 

need to think through in a little more detail how we can make this 

work. 

Mr. HENDERSON. I should mention that even in the absence of 

the legislation we at CDC are still, we will drive ahead and try ro 

pull this together for our own purposes. 

Chairman COX. The other members have been very generous 

with the chairman, and the Chair recognizes the ranking member 

from Texas, Mr. Turner. 

Mr. TURNER. I thank you, Mr. Chairman. Dr. LaMontagne, I 

want to follow up on our earlier line of questioning. As I had 

shared with you, and I know you are aware, the statute that is 

being proposed, the so-called BioShield legislation, deals not with 

the development of the drug, but with the production phase of a 

vaccine. And in your testimony earlier you said that the most difficult area in the development of a vaccine is the research and development and infrastructure piece. Can you expand upon what 

that is briefly? 

Dr. LAMONTAGNE. Well, what I was alluding to was that for 

many of the drugs and vaccines that we use in everyday use today, 

you need to have basically, fundamentally a dedicated facility almost that can produce these things in the quality and the quantity 

that is needed. That is not something that occurs in the context of 

a research entity necessarily. But let me give you an example. 

For many years the NIH and CDC and other agencies worked on 

the development of a meningitis vaccine for children called 

Haemophilus influenzae type B. This vaccine has been so successful it has eliminated the disease in the United States. But to 

produce it in the quantities that were required to deliver it to every 

child in the United States required a huge investment in the manufacturing sector. That is what I am talking about, that there is 

a need at the pull end of the process to have the resources available that can facilitate that translation from the basic clinical research finding to broader use in the population. 

Mr. TURNER. If you had a promising vaccine and you brought it 

through the basic research and applied research stage, I believe 

you testified that in your center you could actually produce about 

10 to 20,000 doses of some vaccine? 
54

Dr. LAMONTAGNE. Yes, we can. That facility, however, I should 

emphasize is a research facility. It is not a manufacturing facility 

and there is an important difference between the two. 

Mr. TURNER. All I was trying to determine is if you are in a position where you have developed a vaccine through the centers of excellence that are being created through the university research centers, and you have a vaccine that has produced 10—or 20,000 doses 

currently, you could actually go out, if you had the dollars appropriated to you, and you could contract with a pharmaceutical manufacturer to produce that vaccine? 

Dr. LAMONTAGNE. I suppose we could, yes, sir. We could contract 

it if we had the resources to do that. I should caution that many 

of the amounts I have seen would be quite huge. You are talking 

hundreds of millions of dollars to do that. 

Mr. TURNER. Right. So it would be a large sum of money. But 

you could currently, under current law you could contract for that 

if you were appropriated the funds to do it. Assuming you have the 

resources available to you and the appropriations, then basically if 

there is a vaccine that your efforts, grants program and centers of 

excellence developed, and you were at that stage where you know 

it is ready to go into the final stages of development and production, we could get those vaccines done. 

Now, under Project BioShield we are envisioning some kind of 

guaranteed level of funding. Based on your knowledge of where we 

are in the development of vaccines for these category A pathogens—and I think you mentioned there are three that really are 

uppermost on your mind: anthrax, smallpox and botulism—if we 

pass this legislation tomorrow, what contract would you suggest to 

Dr. Fauci and Tommy Thompson that we enter into immediately? 

And with what company? 

Dr. LAMONTAGNE. Well, I think that the vaccines that are currently being developed are not at the stage, unfortunately, where 

one could expand them into large production at the present time. 

But I think the ones that you have cited, anthrax, a new smallpox 

vaccine, perhaps, antitoxin for botulism, other vaccines in that general category, even an Ebola vaccine, these are all viable candidates for this expansion process if one had it available. 

Mr. TURNER. Is there anybody out there right now at the door 

that you are aware of? 

Dr. LAMONTAGNE. There is no large vaccine manufacturer at the 

door saying that they are ready to produce any of these vaccines 

in large amounts. 

Mr. TURNER. I just wanted to be sure we shouldn’t continue to 

meet through the weekend here to be sure we don’t delay this at 

all. One other question that I have before my time expires: When 

we talk about the biological threat, we have got all these possibilities of different strains of anthrax and we have been told that you 

may develop a vaccine and then find out somebody has altered the 

strain and it is not effective. How are we going to deal with that 

kind of threat? Because once you contract for the production of 

some particular vaccine it seems to me that if somebody is smart 

enough to alter the strain, then the contract you just entered into 

is basically useless and you have to go back and do another one. 

Is that the reality of the bioterrorist threat that we face? 
55

Dr. LAMONTAGNE. Well, I think there is an element of that reality in all the decisions that we are facing, but I am not sure I 

would paint it quite that starkly. I mean, I think that there is utility to these vaccines from a biological, technical perspective. I think 

a vaccine that induces antibodies to the protective antigen, which 

is in the case of anthrax the most important constituent that can 

first protect, would be useful no matter what kind of interventions 

or changes one might make in the organism itself. I am not aware 

that one can develop a vaccine that would escape the neutralizing 

capacity of the immune response generated by that antigen. That 

may be possible, but I think it is a very difficult technical problem 

for someone to do. But you are right. There is a risk in all of these. 

This is not the same thing as a vaccine for a traditional public 

health problem like measles or rubella. We are dealing with a problem where a manipulation by some external forces might actually 

influence the outcome quite dramatically. So we do have to have 

a nimble response if we can. 

Mr. TURNER. My time has expired. I have a couple of other questions. I will reserve them. Thank you. 

Chairman COX. The gentlelady from Texas, Ms. Jackson-Lee, is 

recognized. 

Ms. JACKSON-LEE. Thank you, Mr. Chairman. Thank you very 

much. And again the witnesses should be certainly acknowledged 

for their willingness to continue with us in what I think is a very 

important hearing. On 9/11, we saw the utilization of common, if 

you will, vehicles and an accelerated utilization of entities that we 

are comfortable with. Airplanes filled with fuel. Prior to 9/11 most 

Americans would not be threatened by an airplane that lifts off to 

the destination of which they choose. We saw those now vehicles 

and fuel source be turned into a terrorist act that was devastating. 

One of the aspects of your testimony included the listing of smallpox, anthrax I think most of us had not heard of prior to the time 

that was used as a terrorist threat and vehicle as well. The plague 

and botulism many of us have read about. 

What about tuberculosis, which is highly infectious? And if utilized by the infected person to be a terrorist vehicle, if you will, 

where are we in terms of either providing for that under the bioscience effort, doing greater research, and preventing that infectious person from becoming a threat from a terrorist perspective. 

I assume it is like going into a crowded theater and being infected 

possibly. And if tuberculosis is a wrong example, if you could utilize any other example, and how are we prepared for that kind of 

threat? Also, if you would expand on the response you gave to 

Chairman Cox about how we could be helpful. Did I hear you say 

that an advisory committee or a group that would provide insight, 

greater insight to how you can use your resources would be helpful? If that is the case I would like that expanded on. 

And I have two specific questions, one to Dr. LaMontagne. You 

are used to—in NIAID I would be interested in how you define biodefense work, but more particularly how do you balance the work 

that is going to be necessary between basic research which traditionally has concentrated on an applied research which can find 

more directly, which can lead more directly to the production of a 

specific vaccine or other countermeasure? The question is how are 
56

you going to balance the work that you already do with new work 

that will be required by this legislation? I think that would be more 

clear. 

And to Dr. Khan, the FDA has used the two animal route for 

testing. We are going to be moving fast and furious, I hope. I hope 

our pharmaceuticals who may be engaged will pierce the issue of 

transparency or will make sure it is transparent and they will in 

fact be accountable, which is one of the things I would like you to 

further respond to. But will we have the capacity as we are moving 

fast and furiously to be able to test these drugs so that they can 

be utilized as quickly as possible? We have a rule against using humans and we understand that. But will we have the capacity to 

meet the test, the challenge that we are going to face when we are 

truly trying to secure the homeland? 

Dr. LAMONTAGNE. Well, let me start first of all with the issue of 

how the institute is trying to balance its biodefense with non-biodefense research responsibilities and then talk a little bit about TB 

in response to your question. I think we have tried very hard to 

maintain our focus, not only on the new responsibility of biodefense, but also we haven’t lost, I believe, any momentum in our 

research activities related to AIDS, particularly AIDS vaccine development and other activities in the non-biodefense area, and we 

are very strongly committed to maintaining that kind of balanced 

portfolio. The basic research that you refer to is fundamentally—

I just want to clarify that the way we look at it and what we are 

trying to achieve is we think basic research is essential to gain fundamental information about these bioterrorist agents. That basic 

information is critical for us to be able to move into the next step, 

which is the development of the drugs, the vaccines and the diagnostic tests that can be used just generally. I think in closing the 

consensus on the utility of tuberculosis as a bioterrorist agent is 

that it is probably very remote. This is a disease that, while certainly an important focus of our attentions in the non-biodefense 

area, is not something that occurs in an acute manner. It is a longterm, chronic, lifelong infection, as you know, and there are effective approaches to try to control it. 

Dr. KHAN. Let me expand on those comments and go back to sort 

of how the list was derived. Tuberculosis is a severe public 

health—it remains a severe public health problem. It is also a severe disease if you are unfortunate to get it, and there are numerous such diseases besides tuberculosis, rabies, HIV, ehrlichiosis, 

toxoplasmosis, et cetera, that didn’t make it on the list, at least A 

and B. Those would generally be covered under the category C 

agents, and the reason is that to derive these priority lists wasn’t 

just a function of whether or not it was a public health problem or 

whether or not the disease was severe but it was additional information on whether or not this agent could be spread to a large 

group of people, what percentage of those, what proportion of those 

people would become sick, and how effective that spreading process 

would be, and then what special preparedness needs would be required, and that is why a number of agents remained in this 

emerging infectious category C. But that I think goes back to the 

broader thing that these bioterrorism agents are just part of this 

bigger issue of emerging infectious diseases and we are always 
57

looking for the flexibility to be able to deal with all of this as a 

group because you do not know what tomorrow’s threat may potentially be or what may show up that you didn’t think about 2 or 3 

years ago. 

Mr. HENDERSON. Just to follow up on your question about the advisory body. Because you are talking about several Federal agencies that are involved in some decision model here, there is three 

things that I think we would benefit from and again we will pursue 

this regardless. And one is informing. You know, this is an advisory body of government nongovernmental officials. Inform us of 

the threats. Then help us prioritize our decision making around the 

type of research that we would do, and the development of the appropriate countermeasures. I think that would be helpful. And the 

third thing is just having an advisory body that can enable effective communication between and among the Federal agency. That, 

I think, would be something that we would find to be extremely 

valuable and we are pushing that now. 

Ms. JACKSON-LEE. I got your two. You said inform us of the 

threat and then an advisory body, but what was the other? 

Mr. HENDERSON. Enable the communication between and among 

Federal agencies. 

Ms. JACKSON-LEE. Thank you. The question about the capacity, 

the two animal capacity in terms of keeping up with the fast pace 

of research, the testing. Anyone have a comment on whether we do 

have that adequate capacity? There is a two animal test I understand, and as we are trying to move as quickly as possible and efficiently as possible, do we have the capacity in that kind of process 

to keep up with the kinds of drugs that are being discovered that 

we are pushing to be discovered? 

Dr. LAMONTAGNE. I think that we don’t have the capacity yet, 

but we are rapidly building it. In the next couple of years I think 

we will have expanded our research laboratory capacity to be able 

to do many of the two animal test protocols that would be required. 

One thing to keep in mind is that these studies by their nature will 

require containment facilities for many of these agents. So as soon 

as that capability is expanded, which is part of our plan currently, 

then we expect we will have sufficient capacity to do much of this. 

Ms. JACKSON-LEE. I thank you very much. In my earlier questions, as I close on this one, I indicated the interest of stakeholders 

like small hospitals and I indicated in my community Riverside 

Hospital and other public hospitals, other institutions. I mentioned 

Texas Southern University, Prairie View A&M only because they 

are in my area, but there are others. I imagine that research can 

be done if you do it in partnership offsite from your respective locations and that you can have collaborative partnerships with institutions like that that may be helpful in some of the testing in other 

areas that you are working in particularly basic research. 

Dr. LAMONTAGNE. That is absolutely correct and we would encourage that. 

Ms. JACKSON-LEE. Thank you. I hear a loud yes. All right. Thank 

you very much. Thank you very much, Mr. Chairman. 

Chairman COX. Mrs. Christensen is recognized once again. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. My first question 

is a relatively simple one I think. How long does it take—and I 
58

hope it wasn’t asked before—how long does is take to develop a 

vaccine to a not seen before agent? Because the bioscience has a 

5-year bring to completion time frame and there was some concern 

raised about that limit, that time limit. 

Dr. LAMONTAGNE. That is a very hard question to answer, but 

a very important question. I think it depends entirely on the agent 

in question. I mean, some vaccines have moved actually very rapidly through the developmental process in the absence of the current pressures we are feeling in terms of biodefense. But I think 

depending on where you stand, let’s say you have the essential 

components of the vaccine identified, you can probably do it in that 

3 to 5-year confine. If you have to start at a fundamental level 

without identifying what will work as a vaccine, it will take much 

longer, perhaps 2 or 3 years beyond that. 

Mrs. CHRISTENSEN. And Dr. LaMontagne, back to you again, too. 

You responded to a question about safeguards in the process a 

while back. And Project Bioscience uses a lot of expedited procedures and really puts a lot of authority in one person, the Secretary 

of Health and Human Services. There are already expedited procedures I believe at NIH and the Food and Drug Administration that 

can be used. Do you see the—can existing expedited procedures be 

used to better protect the public especially since some of the approvals can be extended if needed and we still have some questions 

about how best to provide compensation for injury? 

Dr. LAMONTAGNE. Well, I think that in response to your question, that most of the—or virtually all of the expedited capabilities 

that we have have been engaged. I think that what we are talking 

about is a need for an enhancement of that capability. The safeguards that I mentioned earlier on have to do as much with the 

safeguards that currently exist in the system, which are actually 

quite robust, to ensure that the vaccines and the medications and 

the drugs that we are providing are produced consistently at high 

quality and do what we intend them to do. 

Mrs. CHRISTENSEN. And one last question. We have had three or 

four hearings on Project Bioscience. There hasn’t really been 

brought to us a Project Public Health. And I know $2 billion, and 

that is just part of it. Let me ask the CDC, how is that—if you 

were asked to—knowing the state of local and State public health 

agencies, areas where high disparities exist and perhaps what that 

2 billion is going to be used for now, how much more should we 

be providing or did you ask for when you put together a proposed 

budget? Where was it? 

Mr. HENDERSON. Just one second. We would like to provide a 

more comprehensive response back for the record if that is okay because the public health system is a complicated situation and it 

really requires a more detailed response. 

Mrs. CHRISTENSEN. Yeah. And we really want to be assured that 

the public health system that is going to deliver the services, the 

vaccines, all these wonderful medicines that we are going to develop, countermeasures, is going to be in place and it is going to 

be in place everywhere. And so we would really appreciate your response, what the needs really are. 

Thank you, Mr. Chairman. 

Chairman COX. The gentleman from Texas, Mr. Turner. 
59

Mr. TURNER. Thank you, Mr. Chairman. Dr. LaMontagne, let’s 

follow up again on my earlier thoughts. Recognizing the limitation 

in the BioShield bill, dealing with the tail-end of the process—that 

is the final stages of its development, production—would you have 

any objection to making the BioShield legislation and its funding 

mechanism available for basic and applied research even perhaps 

just in the event of a national emergency where there was a determination made that there was a material threat to the U.S. population? 

Dr. LAMONTAGNE. Well, that is an interesting and provocative 

question, Mr. Turner. I am not sure if, in the current situation, 

that is necessarily needed. That is my own opinion. I mean, I think 

that there is a quite healthy funding stream going into the basic 

research elements of the research agenda for all of these countermeasures. What is really needed is that pull component that we 

have talked about. However, is that going to be an absolute? 

Should there never be a circumstance in which we might—which 

I think is at the heart of your question—where one might want to 

do this. I really can’t predict that. I don’t foresee it currently. But 

it is certainly possible that one might want to entertain that prospect sometime in the future. 

Mr. TURNER. Well, as you know, the BioShield legislation itself 

says that the funding is not triggered until there is a finding that 

there is a material threat to the U.S. population. So I wouldn’t 

really be suggesting that what you are doing now is not likely to 

be sufficient. I am talking about that circumstance where we are 

confronted with a biological threat, where the determination is 

made as provided for under the legislation. If there is a material 

threat to the United States population, would you have any objection to giving the authority to the President or to the Secretary of 

HHS or DHS the power to make the determination that the funding that is there could be applied on an emergency basis through 

the applied research to finding a vaccine that we need to address? 

Dr. LAMONTAGNE. In the scenario you are asking about it would 

be a situation—I just want to make sure I understand what exactly 

you are asking me. And as I understand the scenario, you are talking about a situation in which a new and novel agent appears as 

a validated threat to the citizens of the United States. Under those 

circumstances I think we should take all options available to us. 

So I suppose in a sense the answer might be yes, but I am not sure 

that that is the wisest use of those resources. I think the intention 

of them, as I understand the bill, is to provide that kind of pull 

component to engage the private sector in some of this research activity as well as the developmental activity. So to the extent that 

it could be covered under that kind of a rubric I think it is probably 

acceptable. 

Mr. TURNER. Well, I would hope that if we did determine that 

there was a material threat to the U.S. population that we would 

be in a position of doing everything we possibly could to address 

it. And as you know, under the legislation there is no funding going 

to be made available to any of these private sector companies for 

the production of a vaccine unless there is a finding that there is 

a material threat to the U.S. population. I think it is a pretty high 
60

standard that is in the bill already unless I misunderstand the intent of the language of a finding of a material threat. 

Dr. LAMONTAGNE. I would have to get back to you on that, sir. 

I am not exactly sure what the standards are because I have not 

been that engaged in those discussions frankly. 

Mr. TURNER. The budget request from NIH is for $1.6 billion for 

the various research, basic research, applied research activities, 

both internal, external grants that you may give to universities and 

others. Could you tell me how those funding streams will break 

down in actual practice, assuming that $1.6 billion is appropriated 

by the Congress, among the grants or the research by universities 

and others versus the monies that you will apply internally on this 

activity? 

Dr. LAMONTAGNE. I don’t have those figures in front of me, Mr. 

Turner, but I will be happy to provide that for the record in writing. But we do have an organized plan to address those issues. 

Mr. TURNER. I don’t mean to confuse you by my line of questioning. I am just one who believes we need to do more and we 

need to do it faster than we are doing. I want to be sure you are 

equipped to the extent to which you need to be to accomplish the 

task of discovering the vaccines, which currently the BioShield legislation, in my understanding, has little to do with. I think that 

side of the equation also deserves the attention of this committee 

and of this Congress. 

Thank you very much for your testimony today. 

Chairman COX. I want to thank the panel very much. You have 

been exceptionally generous with your time, your knowledge and 

your expertise, very helpful to this committee as we move forward 

to mark up the BioShield legislation. 

I want to ask one question as we wrap up. It is by inference from 

what I have listened to throughout the morning that both of you, 

for NIAID, for CDC, it would be helpful to have as much information from the Intelligence Community as possible for you to continue to prioritize your work. Is that correct? 

Dr. LAMONTAGNE. Absolutely. Yes, Mr. Chairman. 

Chairman COX. That the more information that you have, respectively, about the actual capabilities of terrorists and states, the better; the more information that you have about the modalities that 

might be employed to disperse microorganisms the better off we 

will be; and the more information that you have about the relative 

likelihood of the use of one biological agent over another the better, 

is that correct? 

Dr. LAMONTAGNE. Yes, sir. 

Dr. KHAN. Yes, sir. 

Chairman COX. It is my reading of the draft legislation that 

would create the bioscience program that the responsibility for seeing to it that that happens would rest with the Department of 

Homeland Security and the Secretary of Homeland Security. I 

think we need, as we move forward, to make sure that this legislation and that other authorities of the Department are adequate so 

that this actually happens. I don’t think we want to find ourselves 

perpetually in a circumstance where you are relying on a 1999 list 

or the communication with the Intelligence Community is episodic. 

Assure that is an ongoing responsibility that would be placed in 
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law for the Secretary of Homeland Security and that the Secretary’s exercise of these authorities would be enormously consequential for you, for the funding that bioscience would make 

available and none of it would be made available without the Secretary’s prior determination. So making sure that those determinations are based on good information both good science and good intelligence is of vital importance. 

So I know you are going to be partnering with other parts of the 

government in this as we go forward. I want to compliment you on 

what you have achieved already over the years and have mercy 

and let you go without continuing to praise you so long that you 

can’t have lunch. Thank you very much for being with us. 

The hearing is adjourned. 

[Whereupon, at 12:10 p.m., the committee was adjourned.]
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APPENDIX 

Materials Submitted for the Record 

QUESTIONS FOR THE RECORD—FOR NATIONAL INSTITUTE OF ALLERGY 

AND INFECTIOUS DISEASES (NIAID) 

(NIAID)—BioDefense Research 

• How does NIAID’s biodefense research compare to what takes place within other 

government agencies, such as the Centers for Disease Control, the Department of 

Defense, and the private sector? 

• How should NIAID balance its work between basic research, which it traditionally 

has concentrated on, and applied research which can lead more directly to the production of a specific vaccine or other countermeasure? 

• Should NIAID be more actively involved in such applied research? If so, how 

should it transition to a better balance between basic and applied research? 

NIAID’s Vaccine Research Center (VRC) 

• How successful has the Vaccine Research Center been in developing needed vaccines? How many vaccines has the Center been responsible for producing since it 

was first created? 

• Does the Vaccine Research Center partner with the private sector to accomplish 

its work? If so, who does what? What is the division of labor between NIAID and 

the private sector? 

• How does the work to be carried out by the private sector under Project BioShield 

compare to the work already being done by the Vaccine Research Center? 

• What is the capacity of the Vaccine Research Center? Is it—or can it be—the government’s alternate to Project BioShield if Project BioShield does not result in procuring needed vaccines and other medical countermeasures? 

Should the Government Do More to Produce Vaccines? 

• If Project BioShield does not succeed in procuring needed vaccines, should the 

government do more—apart from the pharmaceutical or biotechnology industry—to 

develop vaccines and other medical countermeasures? 

• If government efforts should be expanded, how should we go about doing so? 

Should NIAID or another government entity be in charge of such work? What resources will be required? 

NIAID Lessons Learned 

• What, in your view, are the principal lessons learned from ongoing government 

efforts to research and produce countermeasures against the highest priority biological agents? What has worked well, and what hasn’t? 

• How important is the private sector been in researching and developing medical 

countermeasures against biological threats? How do the private sector’s efforts complement similar efforts underway within the government? 

Testing of vaccines 

• Is there sufficient capacity—either in the government or in the private sector—

to test vaccines using the Food and Drug Administration’s ‘‘two animal rule?’’

• If not, what plans exist, or what efforts are currently underway, to boost testing 

capacity? Will NIAID’s ‘‘facilities improvement’’ initiative for this fiscal year help in 

alleviating any problems?

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