```

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

    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

                               __________

                    U.S. GOVERNMENT PRINTING OFFICE
97-504                      WASHINGTON : 2004
____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512�091800  
Fax: (202) 512�092250 Mail: Stop SSOP, Washington, DC 20402�0900012004

                 SELECT COMMITTEE ON HOMELAND SECURITY

                 CHRISTOPHER COX, California, Chairman

JENNIFER DUNN, Washington            JIM TURNER, Texas, Ranking Member
C.W. BILL YOUNG, Florida             BENNIE G. THOMPSON, Mississippi
DON YOUNG, Alaska                    LORETTA SANCHEZ, California
F. JAMES SENSENBRENNER, JR.,         EDWARD J. MARKEY, Massachusetts
Wisconsin                            NORMAN D. DICKS, Washington
W.J. (BILLY) TAUZIN, Louisiana       BARNEY FRANK, Massachusetts
DAVID DREIER, California             JANE HARMAN, California
DUNCAN HUNTER, California            BENJAMIN L. CARDIN, Maryland
HAROLD ROGERS, Kentucky              LOUISE McINTOSH SLAUGHTER,
SHERWOOD BOEHLERT, New York            New York
LAMAR S. SMITH, Texas                PETER A. DeFAZIO, Oregon
CURT WELDON, Pennsylvania            NITA M. LOWEY, New York
CHRISTOPHER SHAYS, Connecticut       ROBERT E. ANDREWS, New Jersey
PORTER J. GOSS, Florida              ELEANOR HOLMES NORTON,
DAVE CAMP, Michigan                    District of Columbia
LINCOLN DIAZ-BALART, Florida         ZOE LOFGREN, California
BOB GOODLATTE, Virginia              KAREN McCARTHY, Missouri
ERNEST J. ISTOOK, JR., Oklahoma      SHEILA JACKSON-LEE, Texas
PETER T. KING, New York              BILL PASCRELL, JR., New Jersey
JOHN LINDER, Georgia                 DONNA M. CHRISTENSEN,
JOHN B. SHADEGG, Arizona               U.S. Virgin Islands
MARK E. SOUDER, Indiana              BOB ETHERIDGE, North Carolina
MAC THORNBERRY, Texas                CHARLES GONZALEZ, Texas
JIM GIBBONS, Nevada                  KEN LUCAS, Kentucky
KAY GRANGER, Texas                   JAMES R. LANGEVIN, Rhode Island
PETE SESSIONS, Texas                 KENDRICK B. MEEK, Florida
JOHN E. SWEENEY, New York

                      JOHN GANNON, Chief of Staff

         UTTAM DHILLON, Chief Counsel and Deputy Staff Director

                  STEVEN CASH, Democrat Staff Director

                    MICHAEL S. TWINCHEK, Chief Clerk

                                  (II)

                            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

                                APPENDIX
                   Materials Submitted for the Record

Questions for the Record--for National Institute of Allergy and 
  Infectious Diseases (NIAID)....................................    62

 
    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 concentrated 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.
    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.
    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 threatening, 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 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 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 cocaine 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 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 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 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 Department 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 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.
    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.
    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 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 identified 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 research 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 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 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.
    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 critical 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, 
milestone-driven 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 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 responses 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, NIH-wide 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 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.
    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

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

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

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 Vaccine 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 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 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 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 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 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. 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 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 responders, 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.
    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 individuals 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 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 military 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 
leadership 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 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.
    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 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 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 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. 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.
    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 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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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 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 day-to-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.
    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.''
    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 review, 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?
    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?
    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 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 long-
term, 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 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 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.
    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 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 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.]

                                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?

                                 

```