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IMPLEMENTING THE NATIONAL

DEFENSE STRATEGY

HEARING

BEFORE THE

SUBCOMMITTEE ON PREVENTION OF 

NUCLEAR AND BIOLOGICAL ATTACK

OF THE

COMMITTEE ON HOMELAND SECURITY 

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

JULY 28, 2005

Serial No. 109–38

Printed for the use of the Committee on Homeland Security 

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

CHRISTOPHER COX, California, Chairman 

DON YOUNG, Alaska 

LAMAR S. SMITH, Texas 

CURT WELDON, Pennsylvania 

CHRISTOPHER SHAYS, Connecticut 

PETER T. KING, New York 

JOHN LINDER, Georgia 

MARK E. SOUDER, Indiana 

TOM DAVIS, Virginia 

DANIEL E. LUNGREN, California 

JIM GIBBONS, Nevada 

ROB SIMMONS, Connecticut 

MIKE ROGERS, Alabama 

STEVAN PEARCE, New Mexico 

KATHERINE HARRIS, Florida 

BOBBY JINDAL, Louisiana 

DAVE G. REICHERT, Washington 

MICHAEL MCCAUL, Texas 

CHARLIE DENT, Pennsylvania 

BENNIE G. THOMPSON, Mississippi, Ranking 

Member 

LORETTA SANCHEZ, California 

EDWARD J. MARKEY, Massachusetts 

NORMAN D. DICKS, Washington 

JANE HARMAN, California 

PETER A. DEFAZIO, Oregon 

NITA M. LOWEY, New York 

ELEANOR HOLMES NORTON, District of 

Columbia 

ZOE LOFGREN, California 

SHEILA JACKSON-LEE, Texas 

BILL PASCRELL, JR., New Jersey 

DONNA M. CHRISTENSEN, U.S. Virgin Islands 

BOB ETHERIDGE, North Carolina 

JAMES R. LANGEVIN, Rhode Island 

KENDRICK B. MEEK, Florida 

SUBCOMMITTEE ON PREVENTION OF NUCLEAR AND BIOLOGICAL 

ATTACK

JOHN LINDER, Georgia, Chairman 

DON YOUNG, Alaska 

CHRISTOPHER SHAYS, Connecticut 

DANIEL E. LUNGREN, California 

JIM GIBBONS, Nevada 

ROB SIMMONS, Connecticut 

BOBBY JINDAL, Louisiana 

MICHAEL MCCAUL, Texas 

CHRISTOPHER COX, California (Ex Officio) 

JAMES R. LANGEVIN, Rhode Island, Ranking 

Member 

EDWARD J. MARKEY, Massachusetts 

NORMAN D. DICKS, Washington 

JANE HARMAN, California 

ELEANOR HOLMES NORTON, District of 

Columbia 

DONNA M. CHRISTENSEN, U.S. Virgin Islands 

BENNIE G. THOMPSON, Mississippi (Ex Officio)

(II) 
(III)

C O N T E N T S

Page 

STATEMENTS

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

of Georgia, and Chairman, Subcommittee on Prevention of Nuclear and 

Biological Attack: 

Oral Statement ..................................................................................................... 1

Prepared Statement ............................................................................................. 2

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

State of Rhode Island, and Ranking Member, Subcommittee on Prevention 

of Nuclear and Biological Attack ........................................................................ 3

The Honorable Bennie G. Thompson, a Representative in Congress From 

the State of Mississippi, and Ranking Member, Committee on Homeland 

Security ................................................................................................................. 55 

The Honorable Donna M. Christensen, a Delegate in Congress From the 

U.S. Virgin Islands ............................................................................................... 48 

The Honorable Norman D. Dicks, a Representative in Congress From the 

State of Washington ............................................................................................. 52

The Honorable Jane Harman, a Representative in Congress From the State 

of Texas ................................................................................................................. 59

The Honorable Bobby Jindal, a Representative in Congress From the State 

of Louisiana .......................................................................................................... 57

The Honorable Edward J. Markey, a Representative in Congress From the 

State of Massachusetts ........................................................................................ 63

The Honorable Michael McCaul, a Representative in Congress From the 

State of Texas ....................................................................................................... 54

The Honorable Eleanor Holmes Norton, a Delegate in Congress From the 

District of Columbia ............................................................................................. 60

The Honorable Christopher Shays, a Representative in Congress From the 

State of Connecticut ............................................................................................. 47 

The Honorable Rob Simmons, a Representative in Congress From the State 

of Connecticut ....................................................................................................... 50

WITNESSES

Dr. Tony Fauci, Director, National Institute of Allergy and Infectious 

Diseases, National Institutes of Health Department of Health and Human 

Services: 

Oral Statement ..................................................................................................... 25

Prepared Statement ............................................................................................. 26

Dr. Julie Gerberding, Director, Centers for Disease Control and Prevention, 

Department of Health and Human Services: 

Oral Statement ..................................................................................................... 5

Prepared Statement ............................................................................................. 13

Brigadier General Eric B. Schoomaker, Commanding General, U.S. Army 

Medical: 

Oral Statement ..................................................................................................... 30

Prepared Statement ............................................................................................. 32

Dr. John Vitko, Director, Biological Countermeasure Portfolio, Science and 

Technology Directorate, Department of Homeland Security: 

Oral Statement ..................................................................................................... 33

Prepared Statement ............................................................................................. 35
Page

IV

FOR THE RECORD

Letter from Dr. Julie Gerberding ........................................................................... 75
(1)

IMPLEMENTING THE NATIONAL 

BIODEFENSE STRATEGY 

Thursday, July 28, 2005

U.S. HOUSE OF REPRESENTATIVES, 

COMMITTEE ON HOMELAND SECURITY, 

SUBCOMMITTEE ON PREVENTION OF NUCLEAR

AND BIOLOGICAL ATTACK, 

Washington, DC. 

The subcommittee met, pursuant to call, at 2:00 p.m., in Room 

1309, Longworth House Office Building, Hon. John Linder [chairman of the subcommittee] presiding. 

Present: Representatives Linder, Shays, Simmons, Jindal, 

McCaul, Langevin, Markey, Dicks, Harman, Norton, Christensen 

and Thompson. 

Mr. LINDER. The hearing will come to order. Please be seated—

our guests. 

The Committee on Homeland Security, Subcommittee on the Prevention of Nuclear and Biological Attack is hearing today testimony 

of implementation of the National Biodefense Strategy. I want to 

welcome our guests and thank them for appearing this day. I look 

forward to hearing each of your unique contributions to implementing a National Biodefense Strategy and especially your efforts 

to prevent a bioterrorism event from occurring in the first place. 

Throughout history, infectious diseases have been a constant for 

civilization. However, al-Qa’ida’s intentions have added a decidedly 

sinister aspect to natural diseases and engineered organisms. The 

reason this subcommittee puts a premium on preventing a bioterrorism attack is simple. Even a limited attack would have tremendous human costs, not just in this country but around the world. 

And the social and economic disruption can be catastrophic to our 

way of life. One only has to look at the SARS outbreak to begin 

to appreciate this impact. Experts estimated the economic impact 

of the 6-month SARS epidemic on the Asia-Pacific region to be approximately $40 billion. In Canada, where 43 people lost their 

lives, the cost to the nation’s economy was $419 million. The cost 

to the Ontario health system alone was $763 million. The SARS 

outbreak also had a substantial impact on the global airline industry. Flights in the Asian Pacific area decreased by 45 percent. 

We are mindful of the recent bombings in London and Egypt, 

which clearly demonstrate the persistent intent of terrorists not 

just to harm us but also our key allies. Conventional means are 

low-hanging fruit for terrorists. However, as technology hurdles to 

acquiring and modifying biological agents continue to fall, we must 
2

leverage this country’s superior science and technological capabilities against bioterrorism. 

The administration and Congress have responded forcefully to 

this threat by making biodefense a top homeland security priority. 

We have done so by creating a blueprint for a coordinated National 

Biodefense Program, dramatically increasing funding for biodefense, research, surveillance and response activities, and encouraging the development of new vaccines, drugs and medical devices 

to combat deadly pathogens. However, these priorities are a joint 

effort within the government. Bureaucracies find it much easier to 

reinvent the wheel instead of collaborating and sharing resources 

and information. Therefore, it is critical to the biodefense efforts 

that the programs that each of you represent be seamlessly leveraged to prevent and, if it does occur, maximize our recovery from 

a bioterrorist event. Otherwise, the consequence is not 3,000 deaths 

but 30,000 or more. 

The wide range of possible biologic agents makes it impossible to 

anticipate every conceivable attack. And, as science advances and 

biotechnology spreads, the list of possible agents will continue to 

evolve. Both of these facts bring us to two irreducible points: people 

and intelligence. If we are to be successful in mounting a defense 

against bioterrorism, every aspect of our strategy must utilize to 

the maximum extent possible the capability of the intelligence community, and each of your efforts must be closely coordinated with 

the IC. Science, tools, reagents and technology may be ubiquitous; 

scientists, however, are not. We have to do a better job of keeping 

track of those individuals with skill sets that are attractive to potential terrorists. 

The threat of terrorism and terrorists will remain with us for the 

foreseeable future. However, the civilized world outnumbers them. 

The capabilities that each of your programs represent must outsmart them. If we remain committed to sustaining our collaborations and building a defense that makes us safe from bioterrorism, 

we also build for this Nation an enduring scientific and medical 

preparedness capability. 

Thank you again to our witnesses for being with us today. I look 

forward to hearing the progress each of your key agencies and programs have made to our Nation’s biodefense. 

And I now recognize my partner, the ranking member, Mr. 

Langevin.

PREPARED STATEMENT OF HON JOHN. LINDER

I would like to welcome and thank our distinguished panel of witnesses for appearing today before this Subcommittee. I look forward to hearing each of your 

unique contributions to implementing the National Biodefense Strategy and especially your efforts to prevent a bioterrorism event from occurring in the first place. 

Throughout history, infectious diseases have been a constant for civilization. However, al-Qa’ida’s intentions have added a decidedly sinister aspect to natural disease 

and engineered organisms. The reason this Subcommittee puts a premium on preventing a bioterrorism attack is simple—even a limited bio-attack would have tremendous human costs, not just in this country, but around the world, and the social 

and economic disruption can be catastrophic to our way of life. 

One only has to look at the SARS outbreak to begin to appreciate this impact. 

Experts estimated the economic impact of the six-month SARS epidemic on the AsiaPacific region to be approximately $40 billion. In Canada, where 43 people lost their 

lives, the cost to the nation’s economy was $419 million. The cost to the Ontario 

health care system alone was $763 million. The SARS outbreak also had a substan-
3

tial impact on the global airline industry—flights in the Asia-Pacific area decreased 

by 45%. 

We are mindful of the recent bombings in London and Egypt, which clearly demonstrate the persistent intent of terrorists not just to harm us, but also our key allies. Conventional means are low hanging fruit for terrorists. However, as technology hurdles in acquiring and modifying biological agents continue to fall, we 

must leverage this country’s superior science and technological capabilities against 

bioterrorism. 

The Administration and Congress have responded forcefully to this threat by 

making biodefense a top homeland security priority. We have done so by: 

• creating a blueprint for a coordinated national biodefense program; 

• dramatically increasing funding for biodefense research, surveillance, and response activities; and 

• encouraging the development of new vaccines, drugs, and medical devices to 

combat deadly pathogens. 

However, these priorities are a joint effort within the government. Bureaucracies 

find it much easier to re-invent the wheel instead of collaborating and sharing resources and information. Therefore it is critical to the biodefense efforts that the 

programs that each of you represent be seamlessly leveraged to prevent, and if it 

does occur, maximize our recovery from a bioterrorism event. Otherwise, the consequence is not 3,000 deaths but, rather, 30,000 or more. 

The wide range of possible biological agents makes it impossible to anticipate 

every conceivable attack. And as science advances and biotechnology spreads, the 

list of possible agents will continue to evolve. Both of these facts bring us to two 

irreducible points—people and intelligence. If we are to be successful in mounting 

a defense against bio-terrorism, every aspect of our strategy must utilize to the maximum extent possible the capability of the intelligence community, and each of your 

efforts must be closely coordinated with the IC. Science, tools, re-agents, and technology may be ubiquitous. Scientists, however, are not. We have to do a better job 

of keeping track of those individuals with skill sets that are attractive to potential 

terrorists. 

The threat of terrorism and terrorists will remain with us for the foreseeable future, however, the civilized world outnumbers them. The capabilities that each of 

your programs represent must outsmart them. If we remain committed to sustaining our collaborations and building a defense that makes us safe from bioterrorism, we also build for this nation an enduring scientific and medical preparedness capability. 

Thank you again to our witnesses for being with us today. I look forward to hearing the progress that each of your key agencies and programs have made to our Nation’s biodefense.

Mr. LANGEVIN. Thank you, Mr. Chairman, for holding this very 

important hearing addressing some critically important issues. I 

would like to take this opportunity to welcome our witnesses here 

today, and I look forward to hearing their testimony. I particularly 

want to welcome Dr. Gerberding back. It was great to visit you at 

the CDC, and I look forward to hearing what you have to say 

today. 

This hearing is a continuation of one we had two weeks ago. During that hearing, we spoke to bioweapons experts about the materials needed and the technical expertise required to produce a biological weapon and to carry out an attack. 

In contrast to the threat of nuclear terrorism, a topic for which 

this committee also has oversight responsibility, the solution to the 

biological threat is much less clear. To build a nuclear weapon, a 

would-be terrorist must acquire weapons-grade uranium or plutonium. If we deny them this crucial ingredient, no nuclear weapon 

can be built. 

I hope, Mr. Chairman, that the work that this committee has 

done in that area will push those committees with jurisdiction over 

programs like Nunn-Lugar to further secure those materials more 

quickly. 
4

However, the testimony we heard last week painted a much different picture regarding bioterror weapons. Our witnesses described the rapidly shifting landscape of many possible pathogens 

that can be obtained through legitimate channels. The situation we 

are facing is one in which the increased efficacy of the technology 

used in bioengineering has lowered the bar such that nonexperts 

now have the ability to build these weapons in home laboratories. 

I would compare it to the improvements in computer technology. 

Ten years ago, you needed a computer expert to send or receive 

audio or video files across the Internet. Today, the technology does 

most of the work for you, and anyone can send these types of files. 

The Centers for Disease Control has identified over 60 pathogens 

that they consider dangerous and for which they suggest the government procure and stockpile countermeasures. A good deal of the 

equipment needed to develop these weapons is readily available. 

Supplies such as DNA, growth media and other solutions can be 

simply ordered through the mail. The next step after creating the 

pathogen is putting it into a form where it can be used as a weapon 

and delivering the weapon to the target. 

Now, according to the witnesses at the last hearing, it is not prohibitively technically difficult to bioengineer a weapon by modifying 

its genetic structure. This presents a three-fold problem: First, the 

natural pathogen can be made much more deadly by including genetic instructions to produce a deadly toxin. The result is a bioweapon with the infection capacity of the original organism but 

with the lethality of the toxin. The second problem they describe 

is with detection. As I understand it, biodetectors are built to look 

for specific sequences and characteristics that identify anthrax, for 

example. But if anthrax is slightly modified, the detector would not 

detect it. Finally, I save the worst for last, our vaccines won’t work 

on the organism if they have been modified for vaccine resistance. 

These problems are deadly serious, and we must move forward 

with a real sense of urgency. I want to thank the Chairman for 

holding such an important hearing, and I look forward to hearing 

from our panel. 

And I want to thank you, and I yield back. 

Mr. LINDER. Members are reminded that opening statements 

may be submitted for the record. 

We are pleased to have a distinguished panel of witnesses before 

us today on this important topic. Dr. Julie Gerberding is the director at the Centers for Disease Control and Prevention at the Department of Health and Human Services; Dr. Anthony Fauci, director of National Institute of Allergy and Infectious Diseases at the 

National Institutes of Health for the Department of Health and 

Human Services; Brigadier General Eric Schoomaker, commanding 

general of the U.S. Army Medical Research and Materiel Command 

of the U.S. Department of Defense; and Dr. John Vitko, director of 

Biological Countermeasure Portfolio, Science and Technology Directorate at the Department of Homeland Security. 

I would like to remind our witnesses that we have a limited time, 

and all of your prepared statements are made part of the record, 

without objection, and if you could summarize in 5 minutes, we 

would be grateful.
5

Dr. Gerberding. 

STATEMENT OF DR. JULIE GERBERDING, DIRECTOR, 

CENTERS FOR DISEASE CONTROL AND PREVENTION, 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Dr. GERBERDING. Thank you, Mr. Chairman. And I really appreciate your having this hearing, and I especially appreciate that you 

and the committee took time to come to Atlanta and really work 

with us in-depth on some of these issues. That was a great boon 

to our engagement and our appreciation for your support. 

CDC is a very important component of our Nation’s health protection. We have actually been in the business of bioterrorism since 

1951 when our epidemic intelligence service was created in response to concerns about bioterrorism in the context of the Korean 

War. And since that time, we have exercised our threat detection, 

intervention and response capabilities more than 10,000 times 

across the United States and in about a thousand communities 

around the world. 

But as you can see from this graphic, since 9/11, the intensity, 

the magnitude, and the impact of the threats that we have been 

addressing have grown substantially in this very global and connected world. And we have had a series of operations that have 

been significant enough, both natural and terrorist in nature, to require us to step up our emergency operations center. And for the 

record, I would like to make note that you have copies of our slides 

as well as a copy of our exposure report and a list of our preparedness goals for CDC. 

In the context of threats this large, we are responsive to one of 

the failures documented in the 9/11 Commission Report, and that 

was the failure of imagination. People have trouble imagining 

things when they can’t imagine how they can handle them. But our 

job at CDC and throughout the Federal Government is to really do 

that imagining, to imagine the unimaginable so that we can take 

steps to prevent the threat, or, when we can’t prevent it, to take 

the steps necessary to prepare people. 

And what we really have here at this table and across the Federal Government and state and local communities is a network of 

prevention and preparedness that has to work in a seamless fashion with a clear strategy. But each of us plays a very unique role. 

So I am going to just describe for you CDC’s role in this, recognizing full well we are just one part of the Department of Health 

and Human Services and one part of the overall responsible workforce in this regard. 

On the next graphic, I have listed the nine preparedness goals 

under which that CDC is operating. These goals were developed to 

prevent, detect, investigate, control, recover and improve our capability to deal with health threats, both terrorist as well as natural 

in nature. These goals drive the work done at CDC and throughout 

the state and local health systems. These goals have clear objectives, they have key performance measures, and we will be reporting on the progress toward achieving these goals over the next several months. 

On the next graphic, I have depicted one of the most important 

core capacities that CDC brings to the table, and that is our sur-
6

veillance capacity. We do surveillance to detect emerging threats in 

all various content domains. But one that we are particularly engaged in right now is the capacity to develop real-time health protection data through communities across our country by tapping 

into health records. I am getting anonymous information about patients’ utilization of services so that we can have the earliest possible warning of an emerging threat at the community level and we 

can have the fastest possible situation awareness about how that 

threat is progressing and how well we are managing it. 

On the next graphic, I have listed another one of our very, very 

important capacities in this regard. I mentioned globalization, 

connectivity and speed as characteristics of threats. CDC has international staff deployed in 43 countries as we speak. These individuals form a very important backbone of threat detection throughout 

our global detection system. And that is on the next graphic. 

You can see how we are linking our existing public health capabilities into a global health protection that takes advantage of our 

quarantine stations, our international field stations, our relationships with the business sector, our sentinel surveillance sites and 

a number of other assets to link our surveillance activities into the 

CDC bio-intelligence center and then to relay information from that 

system to Homeland Security and other intelligence centers so that 

it can be integrated. 

On the last graphic, I would just like to point out another one 

of our very critical core capacities. That is certainly our laboratory 

capacity. Mr. Chairman, these are four of the buildings that will 

be opening at CDC on September 12 this year. 

We thank you and the Georgia delegation as well as the Congress for their support of these buildings. But three of these buildings represent new state-of-the-art laboratories, bringing our total 

laboratory capacity to more than a million square feet. We have the 

national treasure for environmental health, the national treasure 

for biodefense, the national treasure for various laboratories related to smallpox as well as of course our capacity in SARS. These 

laboratories at CDC are part of our overall laboratory response network that again supports Homeland Security activities and other 

threat assessment and response capabilities, and I think really 

speaks to the fact that the science is behind everything that we do, 

and we are using that science not only to take threats off the table 

but also to detect, respond, and mitigate them as quickly as we 

possible can. So thank you for your support. And we look forward 

to your questions.
7
8
9
10
11
12
13

[The statement of Dr. Gerberding follows:]

PREPARED STATEMENT OF DR. JULIE L. GERBERDING

Good afternoon, Chairman Linder and Subcommittee members. I am Dr. Julie 

Gerberding, Director of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). I appreciate the opportunity to 

share with you CDC’s unique role and contributions to building national biodefense 

capacities, particularly with regard to Biodefense for the 21st Century. 

The philosophy of public health during the 20th century has been to prevent natural outbreaks. In the 21st Century, however this is not enough. The threat of terrorism necessitates that we improve our public health and medical systems so that 

we can respond with greater flexibility, speed, and capacity to handle mass casualties and large-scale emergency response in coordination with our traditional emergency response partners as well as those at Department of Homeland Security 

(DHS) and Department of Defense (DoD). 

HHS is responsible for leading Federal public health efforts to ensure an integrated and focused national effort to anticipate and respond to emerging biological 

and other weapons threats. HHS is also the principal Federal agency responsible 

for coordinating all Federal-level assets activated to support and augment the state 

and local medical and public health response to mass casualty events. Within HHS, 

CDC supports these activities through extensive coordination and collaboration with 

a number of federal departments and agencies. 

T2CDC’S Strategic Preparedness Framework 

The events of September and October 2001 made it very clear that terrorism is 

a serious threat to our Nation and the world. The Bush Administration and Congress responded forcefully to this threat by providing funding to strengthen our 

medical and public health capacities to protect our citizens from future attacks. To 

support HHS, CDC has made terrorism preparedness and emergency response one 

of two overarching agency goals and has built an infrastructure to catalyze and implement biodefense activities and collaborate with our Federal, state, and local government partners as well as with the private sector, non-governmental organizations, and tribal nations. 

To do this effectively, CDC has established nine agency preparedness goals to 

strategically focus and efficiently direct CDC resources. For the purposes of this testimony each of the goals has been categorized according to the four essential components of our national biodefense program as identified in the HSPD–10.

1. Threat Awareness: 

• Decrease the time needed to classify health events as terrorism or naturally 

occurring in partnership with other agencies. 

2. Prevention and Protection: 

• Increase the use and development of interventions known to prevent human 

illness from chemical, biological, radiological agents, and naturally occurring 

health threats.

3. Surveillance and Detection: 

• Decrease the time needed to detect and report chemical, biological, radiological agents in tissue, food or environmental samples that cause threats to the 

public’s health. 

• Improve the timeliness and accuracy of information regarding threats to the 

public’s health as reported by clinicians and through electronic early event detection, in real time, to those who need to know.

4. Response and Recovery: 

• Decrease the time to identify causes, risk factors, and appropriate interventions for those affected by threats to the public’s health. 

• Decrease the time needed to provide countermeasures and health guidance to 

those affected by threats to the public’s health. 

• Decrease the time needed to restore health services and environmental safety 

to pre-event levels. 

• Increase the long-term follow-up provided to those affected by threats to the 

public’s health. 

In addition to these eight goals, CDC has a ninth goal under the heading of ‘‘Improvement’’ to decrease the time needed to implement recommendations from after 

action reports following threats to the public’s health. Taken together these goals 

provide CDC a strategic framework from which to establish and implement preparedness programs with the goal of integrating our activities with those of our 

emergency response partners at all levels of government and the private sector.
14

Key Activities and Accomplishments 

For the purposes of this testimony, I will now share with you CDC’s unique blending of leadership and supporting roles under Biodefense for the 21st Century highlighting three priority areas: 

• Laboratory Capacity 

• Surveillance and Detection 

• Response Capacity 

For each of these areas, I will address CDC’s activities and accomplishments toward building these capacities at the local, State and Federal levels.

LABORATORY CAPACITY 

CDC is internationally recognized as a world leader for its premier clinical and 

chemical laboratories. To help strengthen our nation’s laboratory capacity in responding to potential terrorism threats, we are aggressively moving forward on several fronts.

Laboratory Response Network Activities 

The Laboratory Response Network (LRN) is a unified network of domestic and 

international laboratories that seeks to meet the needs for analysis of all specimen/

sample types (e.g., clinical, environmental, food) and agent types (e.g., chemical, biological, radiological). The objective of the LRN is to ensure an effective laboratory 

response to bioterrorism by helping to improve the Nation’s public health laboratory 

infrastructure, through uniform diagnostic standards and protocols. Currently, there 

are more than 150 laboratories, representing all 50 states which make up the LRN. 

In addition more than 10 Federal agencies or departments actively participate in 

supporting the LRN including CDC, Food and Drug Administration (FDA), United 

States Department of Agriculture (USDA), Department of Energy (DOE), Environmental Protection Agency (EPA), DoD, Federal Bureau of Investigation (FBI), and 

DHS. 

To further expand and improve national laboratory response to an event, the 

Interagency Consortium of Laboratory Networks (ICLN) is a network of networks 

which was established six months ago to promote collaboration, communication, and 

technical acuity throughout the government’s overall response strategy. This DHSled group includes representatives from HHS (including CDC), USDA, DoD, DOE, 

EPA, Department of Commerce, Department of the Interior, Department of Justice, 

and the State Department. Together, all of these lab networks cover the diverse biological, chemical, radiological and nuclear materials that may be detected in clinical, 

environmental or food samples. The ICLN envisions a US homeland security infrastructure with a coordinated and operational system of laboratory networks that 

provides timely, high quality, and interpretable results for early detection and effective consequence management to acts of terrorism and other events requiring an integrated laboratory response.

National Interagency Biodefense Campus Initiative 

The National Interagency Biodefense Campus (NIBC) is standing up at Fort 

Detrick to leverage and expand key competencies to achieve productive and efficient 

interagency cooperation in support of Homeland Security Biodefense. The co-location 

and collaboration of partners from DoD, HHS, DHS, and USDA provides a unique 

opportunity for coordinating and synchronizing areas of common interest among the 

federal agencies involved in medical research and/or biotechnology related to biodefense. The confederation of members promotes federal interagency coordination in 

facilities planning, technology sharing, and sharing of expertise, while minimizing 

duplication of effort, technology, and facilities.

CDC’s Environmental Health Laboratory 

CDC and the Agecy for Toxic Substances and Disease Registry (ATSDR) is responsible for detecting, responding to, and preventing human illness caused by a chemical release. Highlights of our accomplishments include: 

• Developing a Rapid Toxic Screen to analyze human blood and urine samples 

for 150 chemical agents likely to be used in chemical terrorism. 

• Assisting local, state, and federal agencies during national and international 

chemical terrorism events, providing chemical and toxicologic expertise, etiologic 

chemical analysis, and clinical guidance. 

• Helping to increase state and local chemical lab capacity through funding, 

technical assistance, training and the conduct of drills and exercises. 

• Supporting surveillance for chemical terrorism events through the American 

Association of Poison Control Centers’ Toxic Exposure Surveillance System 

(TESS), which monitors and analyzes real-time data from the nation’s poisoncontrol centers.
15

Select Agent & Toxins Program 

Through the Select Agent and Toxins Program within CDC, HHS regulates the 

possession, use, and transfer of 39 biological agents and toxins that have the potential to pose a severe threat to public health and safety. The CDC Select Agent and 

Toxins Program oversees these activities and registers all laboratories and other entities in the United States that possess, use, or transfer a select agent or toxin. 

Currently there are 333 entities registered with the Select Agent and Toxins Program including academic institutions; biomedical centers; commercial manufacturing (e.g., the pharmaceutical industry) or distribution facilities; federal, state, 

and local laboratories (including clinical and diagnostic laboratories); and research 

facilities. 

Similarly, USDA has the responsibility of regulating pathogens that affect animals or animal products, plants or plant products. CDC collaborates with USDA to 

ensure that both regulations are harmonized and consistent.

SURVEILLANCE AND DETECTION 

Historically, CDC has engaged in environmental and biological surveillance to 

track and respond to natural or unintentional man-made threats to the public’s 

health. Because of this tradition, CDC has well-established partnerships with state, 

local and Federal agencies involved in bio-surveillance. These partnerships are 

being significantly expanded in the area of active reporting as well as exploring new 

methods of biologic threat detection domestically and globally. 

BioWatch Preparedness and Response 

A new system of providing around the clock detection capability is the BioWatch 

environmental surveillance program. This program utilizes automatic biohazard detection sensors placed strategically across the nation to detect potential threats to 

the public’s health. CDC is working in tandem with the DHS, DOJ, and the EPA 

in the implementation of this program. These agencies have jointly developed draft 

guidance for BioWatch Preparedness and Response. This guidance is a three part 

tool that clearly articulates protocols and procedures for BioWatch-specific environmental sampling and response. 

BioSense 

BioSense is a significant expansion of information that CDC has traditionally collected from Federal, state and local reporting sources. It is a comprehensive public 

health data mining activity that integrates traditional and novel sources of public 

health data to enhance detection, quantification, and localization of possible bioterrorism attacks and outbreaks. In addition, it directly supports epidemiological investigation, event containment, and emergency response and recovery operations. 

• BioSense also provides Early Event Detection (EED) and Situational Awareness (SA) capabilities to state and local public health departments, and specifically to cities where BioWatch sensors have been deployed. There are approximately 400 users enrolled representing 49 states, one territory, and 34 major 

metropolitan areas. Current data sources include DoD and Veterans Affairs 

(VA) ambulatory care data, laboratory test orders from Lab Corp Corporation, 

and BioWatch sensor results. 

• BioSense continues to refine and expand this important data resource and is 

currently collaborating with the EPA on the potential use of water system testing data as another source for Early Event Detection as well as with DoD and 

the VA in strengthening their detection capacity through the utilization of 

BioSense data. 

Biological Threat Characterization Program 

CDC is an active participant in the Biological Threat Characterization Program 

(BTCP) which is a component center of the National Biodefense Analysis and Countermeasures Centers (NBACC) within DHS. A number of Federal agencies participate in this program including the FBI, CIA and DoD. BTCP has been tasked to 

provide bi-annual risk assessments for biological threat agents of concern. CDC subject matter experts are providing technical input to this process and will participate 

in the review of the final results. 

Global Disease Detection 

CDC is renowned as an international public health agency. Medical doctors, researchers, and epidemiologists from around the world contact CDC for advice on the 

evaluation and diagnosis of patients feared to have bioterrorism-associated or 

emerging infectious diseases. CDC staff are available twenty four hours a day, seven 

days a week to provide telephone and on-line consultations. 

The Global Disease Detection initiative aims to recognize infectious disease outbreaks faster, to improve the ability to control and prevent outbreaks, and to detect 

emerging microbial threats. CDC will continue implementing a comprehensive system of surveillance by expanding the Emerging Infections Program and the Field 
16

Epidemiology and Laboratory Training Program. This network is a phased approach 

that requires ongoing support for existing country/regional platforms while bringing 

a high level of focus and attention to develop new sites. An effective network will 

have a strategic presence across the globe with an information technology and laboratory infrastructure that would allow for the broadest possible detection and response capacities before a significant event occurs. Additional activities include improving early warning systems; researching new viral strains; aiding in collaborations with multinational organizations; and augmenting surveillance. 

Recently CDC experts have assisted in ruling-out smallpox in a patient in Africa, 

and in providing injury checklists to help evaluate victims of the London terrorist 

bomb attacks. 

CDC also has provided direct, in-country technical and operational support to 

large-scale international activities, such as the 2004 Summer Olympics in Athens, 

Greece.

RESPONSE CAPACITY 

CDC is unique in its ability to rapidly mobilize pharmaceuticals and medical supplies to anywhere in the country within a 12 hour window from the decision to deploy these assets. In addition, our agency can bring to bear its formidable arsenal 

of scientific knowledge and subject matter expertise to assist in responding to and 

containing public health emergencies. Our goal is to increase this capacity even 

more with a priority focus on building response capacity at the state and local levels. 

Preparedness and health security are a shared Federal, state and local responsibility. NIH is leading the way in the development of new medical countermeasures 

to threats we face. HHS has completed contract awards for the acquisition by the 

Strategic National Stockpile (SNS) of several new countermeasures, including the 

next-generation anthrax vaccine, under Project BioShield. CDC, meanwhile, is working closely with state and local health departments, federal agencies and departments including FDA, HRSA, DoD and other key stakeholders to create a seamless 

response network to ensure that these countermeasures can be delivered in a timely 

and effective fashion. 

We have accomplished much but there is much more to be done. We continually 

explore options to strengthen the dispensing of countermeasures to save as many 

lives as possible in those first critical hours or days of a major emergency. HHS is 

working in concert with partners and stakeholders to advance the best strategies 

to ensure medical countermeasures are readily available to protect individuals in 

the event of a terrorist attack or naturally occurring health problem.

Cities Readiness Initiative 

CRI is a multi-agency initiative spearheaded by HHS and DHS. Other participating agencies include DOJ, FBI, VA and the United States Postal Service. The 

intent of the Cities Readiness Initiative (CRI) pilot is to build capacity for catastrophic public health emergency response in densely populated areas. Specifically, 

the Cities Readiness Initiative is designed to significantly improve the operational 

capability of 21 large metropolitan areas to receive, distribute and dispense SNS assets. Each designated city should be able, in the wake of a bioterrorism event for 

which antibiotics are an appropriate countermeasure, to provide such prophylaxis 

to the known and potentially affected population within 48 hours of the time of the 

decision to do so. 

Under this program, 20 cities and the District of Columbia receive direct assistance through CDC’s Public Health Emergency Preparedness cooperative agreement. 

Participating cities include: Atlanta, Boston, Chicago, Cleveland, Dallas, Denver, 

Detroit, Houston, Las Vegas, Los Angeles, Miami, Minneapolis, New York City, 

Philadelphia, Phoenix, Pittsburgh, St. Louis, San Diego, San Francisco, Seattle, and 

the District of Columbia/National Capitol Region. 

CDC’s Division of Strategic National Stockpile (DSNS) supports this initiative 

with on-going technical assistance to ensure SNS assets are received and dispensed 

efficiently and effectively. 

CDC conducted its own internal assessments in all 21 cities at baseline. These 

preliminary assessments showed initial improvement. CDC is currently working 

with partners and a research organization to externally validate CDC’s rating tool.

State and Local Readiness Program 

CDC administers the Public Health Emergency Preparedness cooperative agreement to assist State and local public health programs in building and improving 

their preparedness capacities. This includes overseeing their progress in completing 

activities that help address CDC’s nine preparedness goals mentioned earlier in this 

testimony, by monitoring 34 measures that have been identified as good indicators 
17

of public health emergency preparedness. As we learn more about effective methods 

of emergency preparedness, the development and refinement of these measures will 

be conducted in collaboration with state, local, territorial, and tribal public health 

input as well as with key partners including National Association of County and 

City Health Officials (NACCHO), Association of State and Territorial Health Officials (ASTHO), Council of State and Territorial Epidemiologists (CSTE), Association 

of Public Health Laboratories (APHL), DHS, and the Federal Emergency Management Agency. Note that these measures were initially refined through review of the 

Target Capabilities List from DHS which provides defines ‘‘nationally accepted preparedness levels of first responder capabilities’’ for state and local programs. 

Risk Communication 

HHS coordinates the development of Department-level training opportunities related to public health and medical emergency response, including providing training 

opportunities for its employees (civil service and uniformed) with the basic tools necessary to manage and operate during a public health emergency. 

CDC has developed a preparedness education strategy that targets public health 

agencies, healthcare organizations, clinicians and laboratorians needed to collaborate to detect, investigate, respond to, and recover from a public health emergency. 

One component of CDC’s preparedness education strategy is directed to developing and providing information to public health workers and clinicians in advance 

of an emerging threat. This education is developed to prepare and alert clinicians 

and public health workers in advance and ‘‘just in case’’ of a potential threat in their 

community, to recognize symptoms, syndromes, or patterns of illness that require 

reporting and to improve their capacity to respond. 

In addition, CDC has invested in the development of ‘‘just-in-time’’ educational 

materials, which are educational methods to provide prompt, emergent information 

as needed and as it becomes available. During an emergency event, CDC is able to 

rapidly provide new information to clinicians and public health professionals, as 

rapidly as possible, through web-based and live satellite broadcast educational programs and other communication channels, to improve response efforts.

Conclusion 

CDC is working hard to meet the public health challenges of the 21st century. 

We are redefining our mission, restructuring the way we conduct business, and reorienting our goals. We are changing as an agency because we must respond faster 

and more efficiently as we protect our nation’s health in today’s world. 

To succeed we rely on many partners including the medical community, federal, 

state and local governments, innovators and the highly talented CDC workforce. 

CDC’s new business model allows us to be the nimble organization that we need 

to be to combat world threats to the public’s health. 

Thank you for the opportunity to be here today. I would be happy to address any 

questions that you may have.
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Mr. LINDER. Thank you, Dr. Gerberding. 

Dr. Fauci. 

STATEMENT OF TONY FAUCI, M.D., DIRECTOR, NATIONAL 

INSTITUTES OF ALLERGY AND INFECTIOUS DISEASES, 

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

Dr. FAUCI. Mr. Chairman, members of the committee, thank you 

for giving me the opportunity to discuss with you this afternoon the 

role of the NIH research endeavor in providing the fundamental 

and ultimately applied research that goes into the development of 

countermeasures against bioterror threats as well as threats that 

naturally occur. I would like to submit for the record these slides 

such that you might have them in front of you as I go through 

them. 

Mr. LINDER. Without objection. 

Dr. FAUCI. The Homeland Security Presidential Directive 10 entitled, Biodefense for the 21st Century, has multiple components. 

The NIH research effort is associated slightly with some of them, 

but very intensively with one in particular that I would like to 

spend a couple of minutes reviewing for you: the development of 

medical countermeasures for the response and recovery phase as 

well for the preparatory phase of diagnostics and vaccines. 

Soon after the September 11, 2001, tragedy, followed by the anthrax attack on this city and New York City, we developed a strategic plan based on the anticipation of a considerable amount of resources that would be put into the preparedness and the research 

arena. So, in collaboration with our sister agencies, the CDC and 

the FDA and elsewhere, we took a look at how we can predict in 

some respects, and we use the CDC category A, B, and C agents, 

and respond in a countermeasure fashion to any of a number of 

threats. We developed a research agenda for these various categories, and over the past year, we have come out with progress 

reports. And I would like to very briefly give you a thumbnail 

sketch of some of the key achievements over the past couple of 

years. 

First, with regard to smallpox. The President himself had asked 

us in the Department what kind of preparation we had very soon 

after the anthrax attacks in 2001 with regard to smallpox. We had 

18 million vaccine doses with a population of 288 million. So smallpox vaccine was a serious problem that we needed to address immediately. We now have more than 300 million doses of smallpox 

vaccine; but since we know there are uncommon but nonetheless 

potentially very serious toxicities associated with that, we now are 

in the developmental phase of a much less adverse event-related 

smallpox vaccine, modified vaccinia Ankara. 

Moving on to anthrax, we now have the next generation recombinant protective antigen which has been under procurement 

through the BioShield law and which in fact is now going through 

testing, showing protection against aerosolized challenge with anthrax. We have the first Ebola vaccine that has been tested in humans and have now gone on to the second-generation vaccine 

which has proved to be safe and in fact virtually 100 percent protective in monkeys. 
26

Botulism toxin is another issue. We have monoclonal as well as 

polyclonal antibodies, and we are developing a more purified approach with monoclonal antibodies. And then finally on this list influenza a very important pathogen because it gives the link between naturally occurring pathogens and naturally occurring potential catastrophes and what we in the health community can do 

to link that to our preparedness to deliberately released microbes. 

And that is the preparation that we at the CDC and NIH and FDA 

are going through in preparedness for a potential influenza pandemic. 

And on this last visual is a map of the world showing some sampling of the emerging and re-emerging infectious diseases that we 

have had to deal with over the past 25 to 30 years. We include deliberately emerging pathogens in that group for a very important 

reason: The preparedness that allows us to respond to a SARS or 

a West Nile or a pandemic flu fundamentally and in principle is 

the same sort of preparedness that will allow us to respond to deliberately released microbes in a very comprehensive way. And it 

is this joining together that I think will hold us in the best stead 

to be able to respond to the threats ahead. 

I will be happy to answer any questions later on. Thank you, Mr. 

Chairman. 

[The statement of Dr. Fauci follows:]

PREPARED STATEMENT OF ANTHONY S. FAUCI, M.D. 

Mr. Chairman and Members of the Subcommittee, thank you for the opportunity 

to discuss with you today the research programs of National Institutes of Health 

(NIH) aimed at developing effective medical countermeasures against bioterror attacks. The terrible events of September 11, 2001, clearly exposed the vulnerability 

of the United States to brutal acts of terrorism. The anthrax attacks that followed 

just a few weeks later made it very clear that the threat of bioterrorism with pathogens or biological toxins represents a serious threat to our Nation and the world. 

The Administration and Congress responded forcefully to this threat, and have 

made biodefense a top national security priority. After a comprehensive review of 

the Nation’s biodefense activities, President Bush in April 2004 signed a Homeland 

Security Presidential Directive called ‘‘Biodefense for the 21st Century’’ that provides a detailed strategy for defending the Nation from biological attacks. This 

strategy has four pillars: Threat Awareness; Prevention and Protection; Surveillance 

and Detection; and Response and Recovery. The NIH was assigned the lead role in 

the development of medical countermeasures to biological attack, and in the conduct 

of research concerning potential agents of bioterrorism that directly affect human 

health. The National Institute of Allergy and Infectious Diseases (NIAID) is the 

NIH institute with primary responsibility for carrying out this assignment. 

In my testimony today I will discuss the NIH biodefense research program, some 

recent accomplishments in NIH biodefense research, and the mechanisms by which 

NIH coordinates its activities with other Federal agencies. I will close with a brief 

discussion of biodefense research to counter possible future threats from engineered 

microbes, as well as research needed to counter naturally emerging and re-emerging 

infectious diseases such as influenza.

NIH Biodefense Strategic Plan and Research Agenda 

The NIH biodefense research program is guided by a comprehensive strategic 

planning process. In February 2002, NIAID convened the Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research, whose members were distinguished experts from academic centers, private industry, civilian government agencies, and the military. Three key documents were developed based on this Panel’s 

advice and on extensive discussions with other Federal agencies. These documents 

are: the NIAID Strategic Plan for Biodefense Research, the NIAID Research Agenda 

for CDC Category A Agents, and the NIAID Research Agenda for CDC Category B 

and C Priority Pathogens. Category A agents are the most dangerous microbes and 

toxins; these agents cause diseases that include anthrax, smallpox, plague, botulism, 

tularemia, and viral hemorrhagic fevers. These agents were given the highest pri-
27

ority because they: (a) are relatively easily disseminated or transmitted from person 

to person; (b) result in high mortality rates with the potential for major public 

health impact; (c) would likely cause significant social disruption; and (d) require 

special action for public health preparedness. Category B agents are in the second 

tier of priority. These are agents that: (a) are moderately easy to disseminate, (b) 

result in moderate morbidity and low mortality, and (c) require specific enhancements of national diagnostic capacity and disease surveillance systems. Category C 

Agents have the next highest priority. They include emerging pathogens that could 

be engineered for mass dissemination in the future because of their availability, 

ease of production and dissemination, and potential for high rates of morbidity and 

mortality and major health impact. 

The Strategic Plan outlines three distinct priority areas for the biodefense research program: development of infrastructure needed to safely conduct research on 

dangerous pathogens; basic research on microbes and host immune defenses; and 

targeted, milestone-driven medical countermeasure development to create the vaccines, therapeutics, and diagnostics that we will need in the event of a bioterror attack. The two biodefense research agendas describe short-term, intermediate, and 

long-term goals for research on the wide variety of agents that could be used to conduct such an attack. Two recent progress reports describe the significant advances 

made toward the goals set forth in these research agendas. All these documents are 

available on the NIAID website at http://www.niaid.nih.gov/biodefense. 

In addition to NIAID’s efforts in biodefense research, in 2004, DHHS tasked the 

Institute with the development of a research program to accelerate the development 

and deployment of new medical countermeasures against ionizing radiation for the 

civilian population. NIAID developed and recently released The NIH Strategic Plan 

and Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats. This Strategic Research Plan and Agenda is organized into four sections: (1) basic and translational research on the mechanisms of radiation injury, 

repair, and restoration that can lead to the identification and characterization of 

new therapeutics; (2) bioassays and tools for biodosimetry, which will aid in diagnosis; (3) immediate product development of promising therapies; and (4) infrastructure to support the necessary research. The document is intended to unify and 

strengthen the research community focused on these areas, promote collaboration, 

and facilitate transition from research to product development. NIH is working 

closely with DHHS to prioritize the research and development activities in this ambitious agenda within the resources available and as one component of the larger 

National medical countermeasures research agenda.

Recent Accomplishments 

Basic research into the interactions between pathogens and their human hosts 

provides the foundation for medical countermeasure development. For example, a 

major NIAID basic biodefense research initiative moving rapidly forward is focused 

on the human innate immune system, which is comprised of broadly active ‘‘first 

responder’’ cells and other non-specific mechanisms that are the body’s first line of 

defense against infection. The delineation of methods to boost innate immune responses could lead to the development of fast-acting countermeasures that would be 

effective against a wide variety of pathogens or toxins that might be used in an attack. In order to develop effective ways to increase innate responses, NIAID-supported scientists at Scripps Institute in La Jolla, CA, are mapping the mechanisms 

by which innate immunity operates and discerning how these responses are triggered. 

NIH biodefense research is ultimately directed toward the development of new 

and effective medical countermeasures, including vaccines, therapeutics, and 

diagnostics against potential bioterror agents. Substantial progress in this area already has been achieved. In the area of therapeutics, for example, NIAID-supported 

scientists recently discovered that a poxvirus infection may be halted by a cancer 

drug aimed not at the virus, but at the human cellular machinery that the virus 

needs to spread from cell to cell. Although much work needs to be done on this concept, this research opens the possibility of providing a therapeutic approach to 

poxviruses such as smallpox and also of circumventing the problem of antiviral drug 

resistance. This approach might also be applicable to other viruses. Researchers 

supported by NIAID also are investigating the use of antibodies that can bind to 

and block the action of toxins produced by the anthrax and botulinum bacteria. 

New and improved strategies for the development of vaccines against potential 

bioterror agents are being pursued vigorously. Our stockpile of usable smallpox vaccines has grown enormously since 2001, when only 90,000 doses were readily available for domestic use. Today, because of clinical research on the minimal dose required to produce immunity and due to an aggressive acquisition program, more 
28

than 300 million doses are held in the Strategic National Stockpile (SNS). Moreover, 

NIAID-supported researchers are testing next-generation smallpox vaccines that 

may prove to be effective against the smallpox virus and safer than the current 

smallpox vaccines, thus potentially allowing them to be used by populations that 

have contraindications for currently available smallpox vaccines, including people 

with weakened immune systems. One of these vaccine candidates, modified vaccinia 

Ankara (MVA), is based on a strain of the vaccinia virus that causes fewer side effects than the traditional Dryvax vaccinia virus strain because it does not replicate 

effectively in human cells. Human trials of MVA vaccines are underway at NIH and 

elsewhere. Encouragingly, vaccine manufacturers Bavarian Nordic and Acambis announced this year that Phase I and Phase II trials have demonstrated MVA vaccine 

to be safe and immunogenic in human volunteers, complementing earlier studies by 

NIAID intramural scientists and their colleagues showing that MVA protects monkeys and mice from smallpox-like viruses. Additionally, NIAID supports a targeted 

research program to reduce the incidence and severity of eczema vaccinatum (EV), 

the most common life-threatening complication of smallpox immunization, and to 

protect individuals with atopic dermatitis from the adverse consequences of vaccinia 

exposure. The Atopic Dermatitis and Vaccinia Immunization Network conducts research that will identify and evaluate ways to reduce the risk of EV. 

NIAID also has made progress in the development of a vaccine to protect against 

viral hemorrhagic fever viruses that could potentially be used as bioterror agents. 

For example, research scientists at the NIAID Vaccine Research Center have completed enrollment of a Phase I human trial of a DNA-based vaccine for Ebola. Thus 

far, the vaccine appears to be safe and immunogenic. 

NIAID also has played a major role in the rapid development of the next-generation anthrax vaccine known as recombinant protective antigen, or rPA. The technology for creating this vaccine was developed at the United States Army Medical 

Research Institute for Infectious Diseases (USAMRIID), and NIAID has supported 

its advanced research and development. Clinical trials to evaluate rPA in healthy 

adults currently are underway. Preliminary unpublished data suggest that the immune responses elicited in humans are similar to those elicited in animal studies. 

Those animal studies have demonstrated that the rPA vaccine protected animals 

against aerosol challenge with anthrax spores. Last November, the Department of 

Health and Human Services (DHHS) awarded a contract for the acquisition of 75 

million doses of rPA vaccine to be held in the SNS. NIAID’s rPA product development initiatives were instrumental in making the initiative possible. Candidate vaccines for plague, botulinum toxin, and other agents are also under development. 

In addition to conducting and supporting biodefense research initiatives, NIH has 

invested in several research infrastructure expansion programs. NIAID has established a nationwide network of Regional Centers of Excellence for Biodefense and 

Emerging Infectious Diseases Research (RCEs). These Centers are now conducting 

fundamental research on infectious diseases that could be used in bioterrorism; developing diagnostics, therapeutics and vaccines needed for biodefense; and providing 

training for future biodefense researchers. Two new RCE awards were announced 

on June 1, 2005, bringing to ten the total number of RCEs nationwide. NIAID also 

supports five Cooperative Centers for Translational Research on Human Immunology and Biodefense to characterize human immune responses to disease-causing 

organisms, develop technologies to measure these responses, and apply this knowledge to design therapies that strengthen host immunity. In addition, NIAID supports the construction of two National Biocontainment Laboratories (NBLs), built to 

Biosafety Level 4 standards and therefore capable of safely containing any known 

pathogen, and nine Regional Biocontainment Laboratories (RBLs) with Biosafety 

Level 3 facilities. NIAID also will support the construction of two additional RBLs 

this year. Together, these high-level research laboratories, some of which are already under construction, will provide the facilities needed to carry out the Nation’s 

expanded biodefense research program with the highest degree of safety and security.

Coordination of NIH-Supported Medical Countermeasures Research 

Although NIH is a leading agency in government-sponsored research to develop 

medical countermeasures against biological threats, it is by no means the only agency involved; the Centers for Disease Control and Prevention (CDC), the Food and 

Drug Administration (FDA), the Department of Defense (DoD), the Department of 

Homeland Security (DHS), the Department of Agriculture (USDA), and other governmental organizations also play important roles. Coordination among the various 

agencies involved is therefore extremely important. In broad terms, Federal medical 

countermeasures research is coordinated at three distinct levels: within NIH, within 

DHHS, and across the government as a whole. 
29

Within NIH. Although NIAID is responsible for the majority of NIH-sponsored 

medical countermeasures research for infectious agents and toxins, other NIH Institutes and Centers make significant contributions. The focal point for trans-NIH coordination and planning of all medical countermeasure research activities in these 

areas is the NIH Biodefense Research Coordinating Committee. I am Chairman of 

this committee, which meets at least quarterly. It is administered by the NIAID Office of Biodefense Research, which also serves as the liaison office for NIH contacts 

with other Federal agencies such as DoD and DHS. 

Within DHHS. Coordination of medical countermeasures research between the 

CDC, NIH, FDA, and other agencies within DHHS is the responsibility of the DHHS 

Office of Public Health Emergency Preparedness (OPHEP). The OPHEP Office of 

Research and Development Coordination holds periodic meetings with all governmental stakeholders in the development of medical countermeasures. 

Across Federal Agencies. At the highest level, coordination of medical countermeasures research is carried out by the White House, and in particular, the Homeland Security Council, the National Security Council, and the Office of Science and 

Technology Policy. The focal point for interagency efforts to establish U.S. Government requirements and prioritize and coordinate medical countermeasures acquisition programs is the Weapons of Mass Destruction Medical Countermeasures 

(WMDMC) Subcommittee (‘‘WMDMC Subcommittee’’). This interagency subcommittee of the National Science and Technology Council is co-chaired by DHHS, 

DHS, and DoD and draws stakeholders from throughout the Federal government. 

Although these three levels describe the structure through which biodefense research programs are formally coordinated, NIH collaborates daily with the other 

Federal agencies and is party to a large number of interagency programs, informal 

contacts, and communication mechanisms that significantly contribute to the efficiency and effectiveness with which medical countermeasures research is carried out 

across the U.S. Government. For example, my staff meets regularly with the Defense Threat Reduction Agency and the Defense Advanced Research Projects Agency, two important entities within the research infrastructure in the DOD. NIH biodefense staff also work closely with the research community at Fort Detrick and the 

United States Army Medical Research and Materiel Command. Moreover, NIH is 

a major participant in the National Interagency Biodefense Campus now under construction at Fort Detrick; once complete, this facility will foster improved coordination and synergy in Federal biodefense activities.

Emerging Engineered and Natural Threats 

Looking toward the future, it is clear that as the power of biological science and 

technology continues to grow it will become increasingly possible that we will face 

an attack with a pathogen that has been deliberately engineered for increased 

virulence. This enhanced virulence could take the form of resistance to one of more 

antibiotic or antiviral drugs, increased infectiousness or pathogenicity, or, in the 

somewhat longer term, a new virulent pathogen made by combining genes from 

more than one organism. Ongoing research to counter these threats includes the development of new broad spectrum therapies, new vaccines with broad cross-reactivity, and immunomodulators to make drugs and vaccines more effective. 

Threats arising from deliberate human action are not the only dangers we will 

confront, because naturally occurring infectious diseases such as HIV/AIDS, SARS, 

and West Nile virus emerge or re-emerge on a regular basis. A current example is 

the H5N1 avian influenza virus, which has killed millions of wild and domestic 

birds, as well as more than 50 people in four countries (Thailand, Vietnam, Cambodia, and Indonesia). There have been two likely cases of human-to-human transmission of the H5N1 virus, and it is possible that other such transmissions have 

occurred recently. It is also possible that the H5N1 virus, through genetic mutation 

or recombination with a human-adapted influenza virus, could become easily transmissible among people. Given the poor condition of public health systems in many 

underdeveloped regions and the speed of modern air travel, the consequences of 

such an event would be severe. 

Although a pandemic alert has not yet been declared, NIAID has taken a number 

of steps to develop and clinically test vaccines against H5N1 influenza. In January 

2004, researchers at St. Jude Children’s Research Hospital obtained a clinical isolate of a highly virulent H5N1 virus and used a technique called reverse genetics 

to create an H5N1 vaccine candidate from this strain. NIAID then contracted with 

Sanofi-Pasteur and Chiron Corporation to manufacture pilot lots of eight and ten 

thousand vaccine doses, respectively. The inactivated H5N1 vaccines will be tested 

in Phase I and II clinical trials that will assess safety and the appropriate vaccine 

dosage to optimize immunogenicity, as well as provide information about how the 

immune system responds to this vaccine. The Sanofi-Pasteur trial, which began on 
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April 4 and is fully enrolled, is testing the vaccine in approximately 450 healthy 

adults. Trials of the Chiron-produced vaccines are expected to begin later this year. 

In addition to these relatively small pilot lots, DHHS contracted with Sanofi-Pasteur to produce two million doses of its H5N1 vaccine, in order to ensure that the 

manufacturing techniques, procedures, and conditions that would be used for largescale production will yield a satisfactory product. Moving to large-scale production 

of the vaccine in parallel with clinical testing of pilot lots is an unusual step, and 

an indication of the urgency with which we have determined that H5N1 vaccine development must be addressed. Waiting for the results of the initial clinical trials, 

which would be the normal procedure, would delay our ability to make large quantities of vaccine by at least six months. These doses, which have now been manufactured, could be used to vaccinate health care workers, researchers, and, if indicated, 

the public in affected areas. 

Antiviral medications are an important counterpart to vaccines as a means of controlling influenza outbreaks, both to prevent illness after exposure and to treat infection after it occurs. Efforts are underway to test and improve antiviral drugs to 

prevent or treat H5N1 influenza. Researchers recently determined that H5N1 viruses are sensitive to oseltamivir, a neuraminidase inhibitor that is marketed as 

Tamiflu and is approved for individuals older than one year. DHHS has deposited 

approximately 2.3 million treatment courses of oseltamivir in the SNS, to which it 

is anticipated that more doses will be added. Scientists are planning to conduct 

studies to further characterize the safety profile of oseltamivir for very young children; other studies are in progress to evaluate novel drug targets, as well as longacting next-generation neuraminidase inhibitors. In addition, development and testing in animals of a combination antiviral regimen against H5N1 and other potential 

pandemic influenza strains is underway. 

NIAID also is developing vaccines that are potentially protective against SARS 

and West Nile virus. NIAID scientists at the Vaccine Research Center have completed enrollment for a Phase I trial of a recombinant SARS DNA vaccine, and have 

initiated a Phase I clinical trial of a DNA West Nile virus vaccine. 

In conclusion, it is clear that defense against biological threats, whether natural 

or the result of deliberate human action, will of necessity continue to be a high national security priority for the foreseeable future. As per the President’s Homeland 

Security Presidential Directive 10, ‘‘Biodefense in the 21st Century,’’ NIH is taking 

the lead in the construction of a sustainable and comprehensive program to develop 

medical countermeasures for biological threat agents. The long institutional experience that NIAID has had with infectious disease research allowed us to rapidly take 

on a greatly expanded role in civilian biodefense after the terrorist attacks in the 

fall of 2001, and I am confident that we are making good progress. 

I appreciate this opportunity to appear before you today, and I would be pleased 

to answer any questions that you may have.

Mr. LINDER. Thank you, Dr. Fauci. 

General SCHOOMAKER. 

STATEMENT OF BRIGADIER GENERAL ERIC B. SCHOOMAKER, 

COMMANDING GENERAL, U.S. ARMY MEDICAL RESEARCH 

AND MATERIEL COMMAND, FORT DETRICK, MARYLAND 

General SCHOOMAKER. Mr. Chairman and members of the committee, thank you for this opportunity to discuss the role of the 

United States Army Medical Research and Materiel Command, or 

MRMC, in the implementation of the National Biodefense Strategy, 

focused around our interagency partnerships. 

I am the commanding general of the MRMC and Fort Detrick. 

I am responsible for delivering the best medical solutions in the 

form of both expertise and products, such as vaccines and therapeutic agents to enhance, protect, and treat the warfighter on point 

for the Nation. Since the 2001 attacks on the United States, this 

mission has expanded to include providing assistance to other Federal partners in protecting the Nation. 

In my short time in this position, I have been very impressed 

with the steps taken by our talented personnel and our interagency 

partners represented here by this panel to implement the National 
31

Biodefense Strategy and congressional guidance. We are clearly on 

the road toward a vigorous and already productive interagency 

partnership that will ensure we meet the biomedical research and 

developmental goals of this strategy. 

Army and DOD researchers have led the medical biodefense research and development for over 35 years. We have gifted people 

with unique expertise, facilities and capabilities and a proven track 

record. Laboratories within the MRMC are leaders in the biodefense effort particularly the United States Army Medical Research Institute for Infectious Diseases, or USAMRIID, which is located at Fort Detrick. Many of the Nation’s biodefense experts 

work at, or have learned their skills from, USAMRIID. Many know 

USAMRIID as the home of the largest biosafety level 4 research capability and as the organization that has been repeatedly called 

upon and has responded to disease outbreaks such as the anthrax 

contaminated letters in 2001. A new USAMRIID facility is an essential element of implementing the National Biodefense Strategy. 

The interagency partnership which I have been discussing, is embodied by the National Interagency Biodefense Campus, or NIBC, 

being planned at Fort Detrick, Maryland. Our challenge at Fort 

Detrick is to become the host of the NIBC, comprised of biodefense 

laboratories of the United States Army, the National Institutes of 

Allergy and Infectious Disease, or NIAID, the Department of 

Health and Human Services, or HHS, the National Institutes of 

Health, the Department of Homeland Security, the Department of 

Agriculture, and, in collaboration with the Centers for Disease Control and Prevention, or CDC, and others. Each NIBC partner will 

implement part of its agency’s overall biodefense program. Collectively, the laboratories and partners will collaborate on developing 

a comprehensive understanding of biologic agent characteristics, 

elucidating disease processes, and developing products to reduce 

risks to human health and agricultural productivity. Additionally, 

the Frederick Campus of the National Cancer Institute of the HHS, 

or the NCI, which is already located on Fort Detrick, will collaborate with and provide biotechnology support for the NIBC partners. 

In summary, we are ensuring the congressionally directed laboratory colocation will become a vibrant interagency partnership to enhance the biodefense of the Nation. 

While DOD must continue to prioritize our projects and dedicate 

our resources to protect and treat the warrior on point for the Nation, we see the NIBC as a unique opportunity. You have heard 

some of these mentioned already. We can develop a more effective 

military program by leveraging complementary efforts of multiple 

agencies to defend our military and our homeland against biowarfare and bioterrism. We anticipate that the colocation will compress 

the discovery cycle to accelerate the development and the approval 

of new medical countermeasures. 

Together, the interagency partners are moving forward to ensure 

that the NIBC follows the National Biodefense Strategy by coupling our complementary efforts. We have already formed coordinating committees. We have already looked into our complementary capacities, and using the pillars of the President’s strategy, 

and we are harnessing our capabilities on an interagency basis so 
32

that we are not duplicative. Our mantra is ‘‘duplication by design 

and not by default.’’ 

Planning for the future is really already informing the present. 

Research collaborations between the Federal agencies and the private industry have already begun. For example, these three agencies have contributed to research and development of this new generation of U.S. anthrax vaccine. 

We feel very good about this collaboration. We are not waiting 

for buildings; the interagency cooperation has begun already. We 

feel that this campus will also prepare us the bench of scientists 

and the critical mass of intellectual power that we require for the 

future to get those unanticipated agents there. 

Mr. Chairman, this concludes my remarks. And I am pleased to 

answer any questions you might have. 

[The statement of General Schoomaker follows:]

PREPARED STATEMENT OF BRIGADIER GENERAL ERIC B. SCHOOMAKER

Mr. Chairman and members of the committee, thank you for this opportunity to 

discuss the role of the U.S. Army Medical Research and Materiel Command, or 

MRMC, in the implementation of the National Biodefense Strategy focused around 

our interagency partnerships. 

I am the Commanding General of the MRMC and Fort Detrick. I am responsible 

for delivering the best medical solutions—in the form of both expertise and products, such as vaccines and therapeutic agents—to enhance, protect, and treat the 

warfighter on point for the Nation. This responsibility includes protection against, 

and treatment for, intentional or natural biological threats. Since the 2001 attacks 

on the U.S., this mission has expanded to include providing assistance to the other 

Federal partners in the protection of the Nation. 

In my short time in this position, I have been very impressed with the steps our 

talented personnel and our interagency partners have taken to implement the National Biodefense Strategy and Congressional guidance. I am proud to describe a 

partnership that goes beyond the Army and the Department of Defense, as we are 

clearly on the road toward a vigorous and already productive interagency partnership that will ensure we meet the biomedical research and development goals of the 

Strategy. 

Army and DoD researchers have led medical biodefense research and development 

for over 35 years. We have gifted people with unique expertise, facilities, and capabilities—and a proven track record. Laboratories within the MRMC are leaders in 

the biodefense effort, particularly the U.S. Army Medical Research Institute of Infectious Diseases, or USAMRIID, which is located at Fort Detrick. Many of the Nation/s biodefense experts are at, or learned their skills from, USAMRIID. Many 

know USAMRIID as the home of largest biosafety level 4 research capability and 

as the organization that has repeatedly responded to disease outbreaks such as the 

anthrax-contaminated letters in 2001. A new USAMRIID facility is an essential element of implementing the National Biodefense Strategy. 

The interagency partnership, which I have been discussing, can be embodied by 

the National Interagency Biodefense Campus, or NIBC, being planned for Fort 

Detrick, Maryland. Our challenge at Fort Detrick is to become the host of the NIBC 

comprised of biodefense laboratories of the the Army; the National Institute of Allergy and Infectious Diseases, or NIAID, of the Department of Health and Human 

Services (HHS) National Institutes of Health; the Department of Homeland Security; the Department of Agriculture; and in collaboration with the HHS Centers for 

Disease Control and Prevention, or CDC; and others.’’

Each NIBC partner will implement part of its agency’s overall biodefense program. Collectively, the laboratories and partners will collaborate on developing a 

comprehensive understanding of biological agent characteristics, elucidating disease 

processes, and developing products to reduce risks to human health and agricultural 

productivity. Additionally, the Frederick Campus of the HHS National Cancer Institute, or the NCI, already located on Fort Detrick, will collaborate with and provide 

biotechnology support for the NIBC partners. 

Using Congressional guidance, we took a proactive role and invited partner Federal agencies mentioned earlier to join us in an interagency campus that would 

build upon the foundation already present at Fort Detrick. We are providing Army 
33

land and Army infrastructure, as well as facilitating the process of interagency leadership. In sum, we are ensuring the Congressionally-directed laboratory collocation 

will become a vibrant interagency partnership that will enhance the biodefense of 

the Nation. 

While DoD must continue to prioritize our projects and dedicate our resources to 

protect and treat the warrior on point for the Nation, we see the NIBC as a unique 

opportunity. We can develop a more effective military program by leveraging complementary efforts of multiple agencies to defend our military and our homeland 

against biowarfare and bioterrorism. We anticipate that collocation will compress 

the discovery cycle to accelerate the development and approval of new medical countermeasures. 

Together, the interagency partners are moving forward to ensure the NIBC follows the National Biodefense Strategy by coupling our complementary efforts. We 

have formed coordinating committees of scientists and others to ensure we address 

the four pillars of the Strategy (Threat Awareness, Prevention and Protection, Surveillance and Detection, and Response and Recovery). While harnessing our interagency capabilities we are avoiding unnecessary duplication and economizing efforts. Our mantra is ‘‘duplication by design and not by default.’’

Planning for the future is already informing the present. Research collaborations 

with Federal agencies and private industry have already begun. For example, three 

agencies have contributed to the research and development of the next generation 

U.S. anthrax vaccine. The technology was developed at USAMRIID, the initial production was accomplished at the NCI, and the final manufacture, licensure, and 

commercialization is being accomplished by the HHS NIAID and the HHS Office of 

the Assistant Secretary for Public Health Emergency Preparedness via contract with 

VaxGen, Inc. through Project BioShield. This serves as a model option, currently 

being followed for other countermeasures, for successful development of solutions for 

national defense. 

The NIBC will enhance our responsiveness to natural public health threats as 

well as intentional bioterrorism; it is important to note that these initially may be 

indistinguishable. For example, interagency partnerships played a key role in developing diagnostic systems and evaluating antiviral drugs for Severe Acute Respiratory Syndrome, or SARS, during an outbreak in several countries. CDC and 

USAMRIID developed tests for this newly emerging disease entity. Additionally, 

NIAID and USAMRIID screened over one hundred thousand compounds against the 

SARS-associated virus and one promising candidate has entered into clinical trials 

sponsored by Intermune, a commercial partner. 

You can see that we are not waiting for buildings; in fact, collaboration existed 

among interagency partners before the NIBC concept was developed and additional 

partnership activities have begun and are further planned. These and other examples demonstrate that we know we are more effective working together than alone. 

One final key aspect of the NIBC is development of the bench by having a critical 

mass of personnel in partnership with the community of Frederick, MD, and academic and business partners. Through these measures, we will have the opportunity 

to improve the intellectual pipeline focused on the Nation’s defense against bioterrorism. 

We’re making significant progress every day toward realizing the vision of the National Biodefense Strategy. Fort Detrick and the NIBC will be a collaborative center 

of biodefense medical research and development excellence for our Nation. All partners have established good working relationships and the Frederick community is 

extremely supportive. 

We are excited to be part of this historic partnership. I want to thank Congress 

for its material support of the non-DoD NIBC partners and for its recognition of the 

MRMC and USAMRIID as pivotal elements of this interagency partnership. 

Mr. Chairman, this concludes my remarks, and I will be pleased to answer your 

questions.

Mr. LINDER. Thank you, Dr. Schoomaker. 

Dr. VITKO. 

STATEMENT OF JOHN VITKO, JR., Ph.D., DIRECTOR, 

BIOLOGICAL COUNTERMEASURE PORTFOLIO, SCIENCE AND 

TECHNOLOGY DIRECTORATE, DEPARTMENT OF HOMELAND 

SECURITY 

Mr. VITKO. Good afternoon, Chairman Linder, and Ranking 

Member Langevin and distinguished members of the committee. I 
34

am pleased to appear before you today to discuss the role of the Department of Homeland Security in implementing the National Biodefense Strategy. This strategy outlines four essential pillars: 

Threat awareness, prevention and protection; surveillance and detection; response and recovery. 

DHS plays a major role in each of these pillars, leading the efforts in risk and net assessments, critical infrastructure protection, 

coordination of attack warning, forensics analysis and support attribution, response planning, and coordinated risk communications. 

In each of these areas, we work closely with our partners such as 

HHS, DOD, USDA, EPA, Department of Justice, and the intelligence community. 

Today I would like to focus on the activities within the Science 

and Technology Directorate, S&T. But, before doing so, it is important to note that other DHS directorates also have major roles in 

implementing the National Biodefense Strategy. 

The emergency preparedness and response directorate and its 

partners have developed a national response plan and a national 

incident management system to guide coordinated Federal, State, 

local and international response to biological attack. The information analysis and infrastructure protection directorate coordinates 

the national infrastructure protection plan. And the public information office coordinates comprehensive risk communication strategies. 

Now I will focus on the role of S&T biodefense activities which 

I direct in implementing the strategy. 

Under threat awareness, the national strategy charges DHS with 

the lead responsibility for conducting threat assessments to help 

prioritize the Nation’s biodefense activities. To this end, S&T is 

conducting threat assessments and material threat determinations 

to help prioritize BioShield acquisitions and inform the associated 

requirements. To date, the secretary of DHS has issued formal determinations for anthrax, smallpox, botulinum toxin, and for radiological and nuclear devices. Three more assessments are in final review, and depending on their outcomes may result in additional 

material threat determinations. 

Second, we are in the midst of a broader set of forma risk assessments covering 29 agents with the results to be available in January 2006. 

Third, we are conducting laboratory experiments to reduce the 

uncertainty in some of the key parameters that affect these assessments. These experiments are being conducted in an interim national biodefense analysis and countermeasure center, NBACC, 

pending the completion of the new facility on the Fort Detrick campus in 2008 as part of the NBIC that General Schoomaker just 

talked about. DHS has also worked closely with HHS in their lead 

to develop a strategy for addressing engineered threats. 

In the area of prevention and protection, S&T’s main role has 

been working on agro defense and, in particular, in the area of foreign animal diseases. In this, we work very closely with USDA. 

S&T owns and operates the Plum Island Animal Disease Center. 

Working with USDA, we have developed and are implementing a 

joint strategy for foreign animal diseases to expedite the transition 

of new vaccines and immunomodulators to National Veterinary 
35

Stockpile and of new validated diagnostics to the National Animal 

Health Laboratory Network. 

Recognizing the Plum Island facility is more than 50 years old, 

we have funded the conceptual design of the next generation facility, the National Bio and Agradefense Facility. S&T has also established two university centers of excellence in agricultural and food 

protection. 

In the area of surveillance and detection, national strategy calls 

for creating a national bioawareness system to permit the recognition of attack at the earliest possible moment. To that end, S&T 

has partnered with EPA and CDC to deploy BioWatch, the Nation’s 

first bio-aerosol monitoring system. This first-generation system 

has been operating for more than 2 years and has performed more 

than 1.5 million assays to date without a false positive. We are currently deploying a second-generation system which greatly increases the number of air samplers and the supporting analysis in 

the top threat cities. And we are in the midst of developing the 

next-generation detection system which will automatically analyze 

the air samples onsite rather than taking them to an off-site laboratory, thereby greatly reducing the cost and making biologics accessible to even more communities. 

We have also taken several major actions to coordinate biodetection activities amongst the various departments. These include an 

interagency memorandum of understanding on coordinated monitoring of biological threat agents, a pilot demonstration of joint civilian and military concepts of operation for early detection and 

characterization of biological events, and a preliminary approach 

for making versions of the high sensitivity, high specificity assays 

developed by the United States Government available to the private sector for commercial development with suitable testing and 

quality control. 

Biodefense for the 21st century also explicitly designates 

NBACC’s, National Bioforensics Analysis Center, NBFAC, as the 

Nation’s lead facility for technical forensic analysis to support attribution. Pending the completion of the new NBACC facility in fiscal 

year 2008, NBFAC has established interim capabilities at 

USAMRIID and is already conducting extensive casework supporting FBI investigations of biocrimes or bioterrorism. 

In summary, DHS has been working closely with its interagency 

partners in fulfilling the important roles assigned to it in the National Biodefense Strategy and has already made major contributions to defending this Nation against attacks with biological 

agents. 

Mr. Chairman, Ranking Member Langevin, and members of the 

committee, I thank you for the opportunity to appear before you, 

and I will be happy to answer any questions you may have. 

[The statement of Mr. Vitko follows:]

FOR THE RECORD

PREPARED STATEMENT OF DR. JOHN VITKO, JR. 

INTRODUCTION 

Good afternoon, Chairman Linder, Ranking Member Langevin, and distinguished 

members of the Committee. I am pleased to appear before you today to discuss the 

role of the Department of Homeland Security (DHS) in the implementation strategy 
36

and progress in executing the major provisions of Biodefense for the 21st Century. 

Biological threats can take many forms and be distributed in many ways. Aerosolized anthrax, smallpox, foot and mouth disease, and bulk food contamination are 

among the threats that can have high consequences for humans and agriculture. 

Recognizing the natural availability of biological agents, their ease of production 

and use, infrastructure vulnerabilities, and need for a coordinated consequence 

management plan for a bioterrorist attack response, President Bush instructed Federal departments and agencies to review their efforts and find better ways to secure 

America from bioattacks. 

In April 2004, this review culminated in approval of a joint strategy entitled Biodefense for the 21st Century. This strategy provides a comprehensive framework for 

our nation’s biodefense. This directive builds upon past accomplishments, specifies 

agency roles and responsibilities, and integrates the programs and efforts of various 

communities—national security, medical, public health, intelligence, diplomatic, agricultural and law enforcement—into a sustained and focused effort against biological weapons threats. 

The Department of Homeland Security (DHS) and the Science and Technology 

(S&T) Directorate have major responsibilities in this integrated national effort. In 

particular, I want to highlight our progress in implementing this comprehensive 

strategy and the effectiveness of our interagency collaborations with our key Federal 

partners, including those represented here today.

Mission and Objectives: 

The presidential directive Biodefense for the 21st Century outlines four essential 

pillars of the nation’s biodefense program and defines the responsibilities of the various Federal departments and agencies with respect to implementing this strategy. 

The four pillars with the designated lead agencies shown in parentheses are: • Threat Awareness, which includes biological weapons-related intelligence 

(intelligence community), risk and net assessments (DHS), and anticipation of 

future threats (HHS). 

• Prevention and Protection, which includes proactive prevention (Department of State, Department of Defense, Department of Justice and the Intelligence Community) and critical infrastructure protection (DHS). 

• Surveillance and Detection, which includes attack warning (DHS) and attribution (DHS analysis in support of lead agency). 

• Response and Recovery, which includes response planning (DHS), mass casualty care (HHS), risk communication (DHS), medical countermeasures (HHS), 

and decontamination (EPA).

MULTIPLE DHS ORGANIZATIONAL ELEMENTS HAVE MAJOR ROLES 

IN IMPLEMENTING THE NATIONAL BIODEFENSE STRATEGY 

Before specifically addressing the activities of Science and Technology Directorate, 

it is important to note that several other DHS organizational elements have major 

roles and responsibilities in implementing the national biodefense strategy. 

The Emergency Preparedness and Response Directorate (EPR) has the lead responsibility for working with other appropriate Federal departments and agencies, 

to develop comprehensive plans that provide for seamless, coordinated Federal, 

state, local, and international responses to a biological attack. To this end, EPR and 

its partners have developed the National Response Plan (NRP) and the National Incident Management System (NIMS). The NRP includes Emergency Support Functions (ESFs) to provide Federal resources during a response, including those for 

public health and medical services (ESF–8, HHS lead) and for agriculture and natural resources (ESF–11, USDA lead). EPR also operates the National Medical Disaster System (NMDS) and works closely with HHS in their lead for mass casualty 

care. 

The Office of Domestic Preparedness/State and Local Government Coordination 

and Preparedness operates the Metropolitan Medical Response System (MMRS). 

The Information Analysis and Infrastructure Protection (IAIP) Directorate has the 

lead for critical infrastructure protection (including agriculture and food); the S&T 

Directorate supports IAIP in this role. IAIP coordinates the National Infrastructure 

Protection Plan (NIPP) which includes shielding critical components of the nation’s 

infrastructure and development of pre-event mitigation strategies. IAIP has the lead 

DHS role in outreach to the private sector through the interfaces provided by the 

various Sector Coordinating Councils and the Government Coordinating Councils. 

IAIP intelligence analysts also work closely with their counterparts in the National 

Counter-Terrorism Center (NCTC) the FBI, CIA and DIA in assessing the intent of 

the enemy, their capabilities, potential scenarios, and attack vectors. Working with 

counterterrorist experts in the Community, they develop link charts on potential as-
37

sociates here in the United States of operatives abroad who may have received 

training in weapons of mass destruction (WMD) capabilities or have knowledge of 

WMD programs. 

The Public Information Office (PIO) works with other appropriate Federal departments and agencies to develop ‘‘comprehensive coordinated risk communication 

strategies to facilitate emergency preparedness for biological weapons attacks. This 

includes travel and citizen advisories, international coordination and communication, and response and recovery communications in the event of a large-scale biological attack.’’

S&T DIRECTORATE ROLES AND ACCOMPLISHMENTS 

Within the S&T Directorate, the responsibilities for implementing the National 

Biodefense Strategy fall within Biological Countermeasures Portfolio, which I direct. 

The mission of this Portfolio is to provide the understanding, technologies, and systems needed to protect against biological attacks on the nation’s population, agriculture, or infrastructure. Within this mission, the S&T Directorate has the lead 

role for decision support tools, risk assessments and support to intelligence, early 

detection and attack analysis, and bioforensics analysis. 

DHS S&T also supports our partnering departments and agencies with their leads 

in other key areas of an integrated biodefense: the Department of Health and 

Human Services (HHS) on medical countermeasures and mass casualty response; 

the Department of Defense (DoD) on broad range of homeland security/homeland defense issues; the U.S. Department of Agriculture (USDA) on agriculture biosecurity; 

USDA and HHS on food defense; the HHS and Department of Veterans’ Affairs (VA) 

on maintaining the Strategic National Stockpile and other pharmaceutical caches 

(antidotes, vaccines and ventilators); the Environmental Protection Agency (EPA) on 

response and recovery, including water safety; the Department of Justice on bioterrorism investigations; and the Intelligence Community on threat warnings. 

Today I would like to focus on the technical progress of the Biological Countermeasures Portfolio as it relates to the pillars of defense outlined in Biodefense for 

the 21st Century.

THREAT AWARENESS 

Under Biodefense for the 21st Century, DHS has the lead responsibility for conducting threats assessments to guide prioritization of the Nation’s on-going investments in biodefense-related research, development, planning, and preparedness. To 

this end, the S&T Directorate is leading three major threat assessment activities: 

• Material Threat Assessments and Determinations to support Project BioShield development of medical countermeasures; 

• Formal periodic risk assessments of a broad range of biothreat agents to 

guide the broader range of bio-defense investments; and 

• Laboratory based characterization of the threats to close key gaps in informing the above risk assessments. 

The first of these activities is being led out of the S&T Directorate’s Biodefense 

Knowledge Center and the latter two out of the BioThreat Characterization Center 

(BTCC) of the National Biodefense Countermeasures and Analysis Center (NBACC). 

In addition to these lead roles, DHS has worked closely with HHS, in their lead 

role, to develop a strategy for addressing engineered threats.

Material Threat Assessments (MTAs) and Material Threat Determinations for BioShield 

The Project BioShield Act of 2004 charges the Secretary of Homeland Security 

with the responsibility to determine which biological, chemical, radiological or nuclear threats constitute a Material Threat to our Nation’s security. To fulfill this responsibility, the S&T Directorate , in partnership with the IAIP Protection Directorate, has been conducting formal threat assessments of the agents of greatest concern to establish plausible high consequence scenarios. These assessments combine 

intelligence information with technical assessments of the feasibility of a terrorist 

to produce and disseminate the agent to provide an indication of the number of exposed individuals, the geographical extent of the exposure, and other collateral effects. If these consequences are of such a magnitude to be of significant concern to 

our national security or public health, the Secretary of DHS then issues a formal 

Material Threat Determination to the Secretary of HHS, which initiates the BioShield process. Subsequently, HHS, assisted by the interagency Weapons of Mass 

Destruction Medical Countermeasures subcommittee, determines the need for, and 

requirements of, any new medical countermeasures. 

To date, the Secretary of DHS has issued Material Threat Determinations for anthrax, smallpox, botulinum toxin and radiological/nuclear devices. Assessments are 

nearly complete for plague, tularemia, and chemical nerve agents, and an assess-
38

ment of viral hemorrhagic fevers will be initiated in August. Based on the outcomes 

of these assessments, the Secretary of DHS may issue additional Material Threat 

Determinations.

Risk Assessments across a Broader Range of Biological Threats 

As part of its responsibility in the President’s National Biodefense Strategy, DHS 

is required to conduct periodic, formal risk assessments of a much broader set of 

biological agents to help prioritize the nation’s ongoing biodefense activities. These 

risk assessments provide a systematic evaluation of the development and deployment of a broad range of biological threats, the vulnerability of different portions 

of our society to those threats, and the resulting consequences of any such attacks. 

The first such formal risk assessment is due in January of 2006, with subsequent 

assessments due every two years. The scope, process, and timescale for this first assessment have been presented to and agreed to by the interagency Biodefense Policy 

Coordinating Committee co-chaired by the Homeland Security Council and the National Security Council. This risk assessment is addressing 29 biological agents and 

is being conducted in partnership with the Intelligence Community, HHS, DoD, 

USDA, EPA, the IAIP Directorate and others. Two advisory boards, one a Government Stakeholders Advisory Board and the other an Independent Risk Assessment 

Expert Review Board (academia, industry, and government), have been established 

to provide input and advice.

A Strategy for Addressing Emerging Threats 

Much of the biodefense efforts to date have focused on protecting against attacks 

with bioterrorism agents that can be (or used to be) found in nature. However, rapid 

advances in biotechnology demand that we also consider the possibility and impact 

of emerging or engineered agents, for example, modifications to organisms that increase their resistance to medical countermeasure or make them more difficult to 

detect. The President’s Biodefense for the 21st Century assigns HHS the lead in anticipating such future threats. The S&T Directorate is partnering with HHS and 

others in formulating and implementing a strategy for anticipating and responding 

to such threats. 

Based on intelligence information, available literature and expert judgment, we 

have developed an informed estimate of the types of emerging threats that might 

be within the ability of a terrorist organization to develop over the near (1–3 years), 

mid (4–10 years), and longer-terms (10 yrs). In this analysis, four elements stand 

out as essential to an effective defense against emerging threats: 

• Threat, vulnerability and risk assessments to prioritize these threats in terms 

of the difficulty of their development and deployment, as well as their potential 

consequences; 

• Surveillance and detection capabilities to rapidly detect and characterize engineered agents in environmental and clinical samples so as to provide timely 

guidance in the selection of the appropriate medical countermeasure; 

• An expanded range of safe and effective medical countermeasures and an infrastructure to support rapid research, development, test, and evaluation 

(RDT&E) of new medical countermeasures; and 

• Integrated concepts of operation (CONOPS) for the identification and response to emerging threats.

Scientific research to better inform these threat and risk assessments 

The threat and risk assessments described above are performed with the best 

available information. However, there are large uncertainties, sometimes factors of 

ten to a hundred, in some of the key parameters and hence in the associated risks. 

One of the major functions of the threat and risk assessments is to identify these 

critical knowledge gaps, which can differ for different threat scenarios—in one case 

it may be the minimum amount of agent needed to infect a person; in another case 

it may be the time that such an agent remains viable (capable of causing an infection) in the air, food or water; and in a third it may be the effect of food processing 

or water treatment on the agent’s viability. Conducting the laboratory experiments 

to close the critical knowledge gaps is a primary function of DHS’s National Biodefense Analysis and Countermeasures Center (NBACC). 

Congress has appropriated a total of $128M for design and construction of 

NBACC with the necessary biocontainment laboratory space and support infrastructure to conduct these and other experiments. NBACC will be built on the National 

Interagency Biodefense Campus (NIBC) at Ft. Detrick, MD, in close physical proximity to the DoD’s United States Army Medical Research Institute of Infectious Diseases (USAMRIID), the HHS National Institutes of Health’s’s Integrated Research 

Facility and the USDA’s Foreign Disease-Weed Science Research Unit. NBACC is 

also collaborating with the HHS Centers for Disease Control and Prevention, a new 
39

member of the NIBC, to further address the critical knowledge gaps. The Record 

of Decision for NBACC’s Final Environmental Impact Statement was signed in January 2005. Design of the facility began in March 2005, with construction scheduled 

to begin in FY 2006 and be complete by the fourth quarter of FY 2008. 

Currently, interim capabilities for both NBACC’s biological threat awareness and 

bioforensic analysis functions have been established with other government and private laboratories to allow vital work in these areas to occur during the NBACC facility’s construction

PREVENTION AND PROTECTION: CRITICAL INFRASTRUCTURE 

PROTECTION: AGRO-DEFENSE 

Biodefense for the 21st Century tasks DHS with leading efforts to protect critical 

infrastructures from biological attack. HSPD–9 further details these responsibilities 

for protecting agriculture and food. Significant S&T Directorate roles include: 

• Acceleration and expansion of the development of current and new veterinary 

countermeasures; 

• Developing with USDA a plan to provide facilities for research and diagnostic 

capabilities for foreign animal and zoonotic diseases; and 

• Establishing new university centers of excellence for agriculture and food security. 

In 2003, the S&T Directorate and USDA (Agricultural Research Service [ARS], 

and Animal and Plant Health Inspection Service [APHIS]) began developing a joint 

strategy for foreign animal disease. One of the first goals of the strategy is to develop veterinary countermeasures for foot and mouth disease. Following the process 

laid out in the strategy, ARS has the lead for basic research and early development 

of vaccines and immunomodulators (antivirals). Potential candidates are then 

transitioned to DHS for continued development with industry. Once appropriate 

products are developed, APHIS supplies them to the National Veterinary Stockpile. 

Interagency coordinating meetings were held as recently as May 2005 to review 

progress on the joint strategy. 

As part of the integrated biodefense complex, the S&T Directorate operates the 

Plum Island Animal Disease Center (PIADC) and two Homeland Security (HS) Centers of Excellence in agricultural security described below.

Plum Island Animal Disease Center 

PIADC is a critical national asset in the strategy for addressing foreign animal 

diseases. This strategy includes programs on: 

• Net assessment of the foreign animal disease threat; 

• Vaccines and therapeutics: 

• Improved current vaccines (onset of immunity, adjuvants); 

• Development of next-generation vaccines and immunomodulators; and 

• Transition of promising candidates to industry partners for full product 

development. 

• Assays and diagnostics: 

• National and international validation; 

• Enhanced diagnostics capability and surge capacity; and 

• A new bioforensics capability. 

The overall goal of this strategy is to expedite the transition of new vaccines and 

immunomodulators to the USDA National Veterinary Stockpile and of new validated diagnostics to the USDA National Animal Health Laboratory Network 

(NAHLN), as well as increasing surge capacity at critical nodes of the response infrastructure. 

In addition to these research and diagnostics programs, the S&T Directorate has 

responsibility for the maintenance and operations of the PIADC facilities, including 

necessary upgrades and enhancements of facilities and security. 

To facilitate overall coordination of these programs at PIADC, a Board of Directors has been established, chaired by the S&T Directorate and including the administrators of both ARS and APHIS. In addition, the Office of Science and Technology 

Policy’s National Science and Technology Council recently established a new Subcommittee on Foreign Animal Disease Threats which is co-chaired by USDA and the 

S&T Directorate and provides a valuable new interagency forum for cooperation.

NATIONAL BIO AND AGRODEFENSE FACILITY 

PIADC is a unique and critical facility for the nation’s foreign animal disease defense and celebrated its 50th anniversary in 2004. Thus, the facility is now well beyond its originally planned life span, and is in need of recapitalization. 

In FY 2005 the S&T Directorate is funding a conceptual design study for a nextgeneration facility, the National Bio and Agrodefense Facility (NBAF). The goal of 

this study is to determine the programmatic drivers for the necessary size and scope 
40

of the facility and the research and development to be conducted there. Three major 

programmatic themes are being considered: 

• The historical PIADC mission for foreign animal disease research in livestock, 

with needs anticipated over the lifetime of the new facility (approximately 40 

years); 

• The study of zoonotic diseases, including associated requirements for specific 

biosafety levels of containment; and 

• Testing and evaluation required for approval of medical countermeasures by 

the Food and Drug Administration (FDA) in HHS. 

DHS is working closely with its interagency partners throughout this planning 

process, including USDA and HHS. 

The proposed FY 2006 budget for DHS includes $23M for the architectural and 

engineering design and pre-construction costs of the NBAF.

University Centers of Excellence 

In addition, the S&T Directorate has established two University Centers of Excellence explicitly focused on agricultural and food protection. Texas A&M University 

and its partners from the University of Texas Medical Branch, University of California at Davis, and the University of Southern California have formed the National 

Center for Foreign Animal and Zoonotic Disease Defense. They are working closely 

with partners in academia, industry, and government to address potential threats 

to animal agriculture, including Foot and Mouth Disease (FMD), Rift Valley fever, 

avian influenza, and brucellosis. The University of Minnesota and its partners, 

Michigan State University, University of Wisconsin at Madison, North Dakota State 

University, Georgia Institute of Technology, and the University of Tennessee at 

Knoxville have formed the National Center for Food Protection and Defense. They 

are addressing food issues related to post-harvest food protection, including developing a prototype food event modeling system, new risk communication approaches 

to minimize the potential impact of food contamination events, and realistic decontamination scenarios involving surrogate agents and food matrices.

SURVEILLANCE AND DETECTION: ATTACK WARNING 

Biodefense for the 21st Century calls for ‘‘creating a national bioawareness system 

(that) will permit the recognition of a biological attack at the earliest possible moment and permit initiation of a robust response to prevent unnecessary loss of life, 

economic losses, and social disruption.’’ Some of the key S&T Directorate activities 

in support of this are: 

• Development and upgrading of a BioWatch, an urban bioaerosol monitoring 

system currently operating in more than 30 cities; 

• Coordination of interagency biodetection activities; and 

• Design of the National Biosurveillance Integration System (NBIS).

BioWatch 

In early 2003, DHS, in partnership with the EPA and CDC, deployed the 

BioWatch environmental monitoring system to protect our nation’s cities from the 

threat and ramifications of a bioterrorist attack This first generation system (Gen 

1 BioWatch) uses air samplers distributed throughout a city, with filters retrieved 

daily or more frequently and brought to a nearby Laboratory Response Network 

(LRN) laboratory for genetic (PCR) analysis. Results are available within 12 hours 

of filter retrieval. This system has been operating for more than two years and has 

performed greater than 1.5 million assays without a false positive. 

We are now in the midst of deploying a second generation system (Gen 2 

BioWatch), which increases the number of collectors in the top ten or so threat cities 

two to four-fold thereby decreasing the minimum size attack that can be detected 

and increasing the probability of detection. 

Because Gen 1 and Gen 2 systems involve the manual collection of filters and 

analysis by laboratory staff, labor costs account for about 75% of the operational 

costs associated with these systems and hence limit both the number of collectors 

deployed and the frequency with which filters are retrieved. To overcome these limitations advanced next generation detection platforms are currently under development which will automatically perform the detection analysis at the air sampling 

sites and wirelessly transmit any positives to the LRN laboratory for human confirmation of the signal interpretation. These systems will allow much more frequent 

sample analysis and address an expanded range of agents. Laboratory tests will be 

completed in FY 2006 and field tests in FY 2007. The system will then be piloted 

in an existing BioWatch city (FY 2008) before initiating full scale deployment in FY 

2009. The autonomous nature of this Gen 3 system and its low operational cost 

should allow us to greatly expand the coverage provided by BioWatch. 
41

We are also developing a Biological Warning and Incident Characterization 

(BWIC) System to assist the local decision makers in determining the public health 

significance of any BioWatch positive and also to assist in reconstructing the event 

to guide the response. To accomplish this BWIC integrates BioWatch data with 

plume and disease modeling and with medical surveillance data (e.g. from CDC’s 

BioSense system) to provide an improved understanding about the possible origin 

and extent of the release and some estimate of its possible impact. BWIC is currently being piloted in in two cities, and upon completion of the pilots will begin 

a phased deployment to other BioWatch cities.

Coordination of interagency bio-monitoring and biodetection activities 

Since the initiation of BioWatch, the United States Postal System (USPS) has initiated the Biohazard Detection System for the monitoring of mail distribution centers and the DoD has initiated its Installation Protection Program Guardian for 

monitoring of military bases. In addition, multiple agencies are involved in the testing of ‘white powders’ from various sources. Recognizing the needed for a more coordinated and integrated approach to such biomonitoring, the S&T Directorate has 

initiated several programs to improve interagency coordination in this area. 

BioNet is a DHS funded, DoD executed program to pilot an integrated civilian and 

military concept of operations for the early detection and characterization of biological events. The pilot is currently taking place in San Diego, CA, and will be completed this fiscal year. It will provide common (or similar) architectures, operational 

protocols and communication processes to link existing/projected civilian and military biological detection systems. 

Bio-monitoring MOU: An interagency Memorandum of Understanding (MOU) on 

Coordinated Monitoring of Biological Threat Agents has been signed by DHS, HHS, 

DoD, DoJ/FBI and USPS and is currently being implemented. The MOU calls for 

a written plan for coordinated air monitoring; protocols and timelines for shared 

prompt notification; determining the ‘‘equivalency’’ of biothreat agent testing performed by the participating agencies; and a joint technology roadmap to better leverage Federal investments. In addition the MOU also contains the initial steps in extending this approach to other biodetection measurements. This MOU seeks to address the issues relevant to biological agent detection and characterization necessary to make public health or national security decisions. It does not address subsequent responses which would be addressed by other arrangements and mechanisms. 

Public Health Actionable Assays: In coordination with CDC and DoD, we are formulating an approach for working with the private sector to make very high quality, 

extremely low false alarm rate assays available to them for use in commercial detection technologies. In this approach, the U.S. Government would provide industry 

with the appropriate signatures to be tested on their detection platforms using their 

protocols but tested by a U.S. designated independent laboratory. If the combination 

of signatures, protocols, and platform meet the equivalency requirements established under the MOU then the combination (called an assay) would be designated 

a ‘‘USG—Public Health Actionable Assay’’ meaning that any positive results would 

not have to be retested in a government laboratory prior to alerting the Public 

Health Community. This approach will be piloted in FY 2006.

Development of the National Biosurveillance Integration System (NBIS) 

There are many other biosurveillance activities being undertaken by various Federal Departments and agencies. For example, CDC is developing an electronic medical surveillance system (BioSense) to look for early medical indicators of a possible 

biological attack, and USDA and HHS are developing the laboratory network for detecting and responding to possible food contamination. It is important that the information from all these sector specific biosurveillance systems be brought together to 

form a comprehensive biosurveillance situation awareness or common operating picture. To that end, the S&T Directorate has worked with the various Federal Departments and with industry to design the National Biosurveillance Integration System 

(NBIS). NBIS will integrate information on the state of health of people, animals 

and plants with bio-monitoring of air and water, with results from regulatory testing of food, and with real-time threat information so as to provide the earliest possible detection and characterization of a possible bio-attack. The initial design was 

completed in early FY 2005 and has been transferred to the IAIP Directorate for 

implementation.

SURVEILLANCE AND DETECTION: ATTRIBUTION 

Biodefense for the 21st Century specifically names the National Bioforensics Analysis Center (NBFAC) of the National Biodefense Analysis and Countermeasures 

Center (NBACC) as the lead Federal facility to conduct and facilitate the technical 
42

forensic analysis and interpretation of materials recovered following a biological attack in support of the appropriate lead Federal agency. As noted above, a new 

NBACC facility will be constructed on the National Interagency Biodefense Campus 

(NIBC) at Ft. Detrick, MD. Pending completion of that facility in FY 2008, an interim NBFAC capability has been established in leased biocontainment space at 

USAMRIID also located at Ft. Detrick. This leased space was totally renovated to 

provide a contamination-free environment for ultra high sensitivity forensic work. 

In a short span of only 12 months, NBFAC has become operational and is now conducting casework supporting on-going FBI investigations of biocrimes or acts of bioterrorism. To date, NBFAC is already processing over a hundred samples per 

month. All evidence receipt, accessioning and processing are being conducted in secure, contamination free, biocontainment space within the interim NBFAC laboratory. This is a capability that was non-existent at the time of the anthrax attacks 

in the fall 2001. 

To further bolster the admissibility and validity of biological evidence analytical 

results used in court proceedings, NBFAC will obtain the International Organization of Standardization (ISO) 17025 certification as a reference analytical laboratory 

in 2005–06. To meet stringent ISO certification requirements, NBFAC has established a stand-alone Safety and Biosurety Program, Quality/Accreditation Program, 

and received select agent handling certification from Centers for Disease Control 

and Prevention (CDC) for all laboratory staff and facilities. Standard operating procedures and protocols are in place for evidence handling and analytical flow processes. 

To provide reference microbiological material against which to compare suspect 

samples, the NBFAC has established a National Bioforensic Repository Collection 

(NBRC). The repository is developing and implementing a comprehensive management plan and acquisition strategy in FY 2005 and will continue implementation 

throughout FY 2006. 

NBFAC has also taken several major steps to extend its analytical capabilities. 

It has implemented interagency agreements with other federal laboratories to provide capability for specialized analysis and surge requirements and it has implemented a robust research and development (R&D) initiative to develop next generation forensic tools. The R&D program focuses on: developing improved protocols for 

sample collection, preparation, and extraction; validating new genotyping approaches for more precise and rapid identification of suspect samples; and implementing novel methods for analyzing of the physical and chemical signatures of biothreat agents and their associated matrices to look for differences in the processes 

used to grow, harvest, process and deliver agents.

RESPONSE AND RECOVERY 

Attack with a biological agent can cause widespread contamination of large outdoor urban areas and the included facilities and critical infrastructure that are beyond the scope of current protocols and procedures to address in a timely and cost 

effective manner. Recognizing the importance of the addressing these issues, Biodefense for the 21st Century has charged EPA, in coordination with other Federal 

departments, to develop strategies, guidelines and plans for decontamination of persons, equipment and facilities and has charged DHS with the lead in developing decontamination methodologies for critical infrastructures. 

To support these responsibilities, the S&T Directorate has focused on providing 

systems solutions through the use of so called domestic demonstrations and applications programs (DDAPs) which bring together users, technologies and procedures to 

demonstrate in integrated solution to a problem. This approach has been used successfully in the past to develop urban monitoring systems which later became 

BioWatch and detection and response systems in transit facilities (PROTECT) currently operating in several metropolitan subway systems. Two DDAPs are currently 

underway on the protection of critical infrastructures, using airports as a model system. The first of these, the PROACT program, has developed ‘‘Guidelines to Improve 

Airport Preparedness against Chemical and Biological Terrorism’’ that have been 

provided to the Transportation Security Administration(TSA) and the Federal Aviation Administration (FAA) for review and distribution to airports around the nation. 

The second of these, the Restoration DDAP, is focused on the recovery of an airport 

following a biological attack. This program in being conducted in collaboration with 

the San Francisco International Airport (SFO), the EPA, and CDC (NIOSH) and is 

focused on developing tools and protocols to significantly reduce the time it currently takes to decontaminate a facility. The major deliverable, due in FY 2006, is 

a pre-reviewed (by EPA) decontamination plan for SFO that can serve as a template/guideline for other airports in the nation and which will have been dem-
43

onstrated in concert with the operational user/facility, responders and other federal 

partners to provide a systems solution to the problem. 

The S&T Directorate also co-chairs with EPA the Subcommittee of Decontamination Standards and Technology, assembled by the Committee on Homeland and National Security of the National Science and Technology Council. The objectives of the 

Subcommittee are to facilitate the development of consistent guidelines, testing protocols, certification methods, and reassessment strategies to address incidents involving biological and chemical agents. The Subcommittee will examine current barriers to standardization and interoperability between agencies and recommend 

strategies to remove such barriers. A technology gap analysis will be performed to 

develop a research initiative as well as addressing Human Decontamination issues.

CONCLUSION 

The Department of Homeland Security and the S&T Directorate’s Biological 

Countermeasures Portfolio fully support the national biodefense program as stated 

in Biodefense for the 21st Century, and other Homeland Security Presidential Directives. Moreover, these programs are conducted in an active collaboration with other 

Federal departments and agencies having a role in meeting this national priority, 

and are focused on reducing the threat of a biological attack against this nation’s 

population and its agriculture and food critical infrastructures, and supports a 

science-based forensics and attribution capability. 

This concludes my prepared statement. With the Committee’s permission, I request my formal statement be submitted for the record. Mr. Chairman, Ranking 

Member Langevin, and Members of the Committee, I thank you for the opportunity 

to appear before you and I will be happy to answer any questions that you may 

have.

Mr. LINDER. Thank you, Dr. Vitko. 

Thank you all. Each of you is involved in, it seems to me, anticipating something and responding to it. Is anybody involved in finding how the intelligence community can intersect with the biological community to find the bad actors and prevent their actions? 

Dr. Gerberding? 

Dr. GERBERDING. We have limited intersection in that regard 

right now. One of our most important domains currently is the recognition that CDC itself is a threat. And so, in cooperation with 

other agencies, we have come to grips with the fact that our own 

internal security and the security of the CDC is something that requires a much greater effort, so the guns and the guards and the 

other security measures that have been part of our portfolio of investments since 9/11 are there in part to deal with that component 

of prevention. But on a more global scale, as we learn about what 

are the signatures of people who are planning threats or what is 

the signature of someone who is working with a biological agent, 

these are areas where I think we have opportunities to expand and 

enhance our intersection with other intelligence agencies. 

Mr. LINDER. Thank you. 

Mr. VITKO. Mr. Chairman, DHS’s information analysis and infrastructure protection directorate has a significant effort in that area. 

Our intelligence 

Mr. LINDER. Dr. Vitko, you spend less than 2 percent of your 

budget on intelligence. 

Mr. VITKO. DHS does? 

Mr. LINDER. Yes. Less than 2 percent. 

Dr. Fauci, does the vaccination for Ebola deal also with Marburg, 

or is it specific to Ebola? 

Dr. FAUCI. We have two vaccines that we are testing, Mr. Chairman. One is a specific for Ebola. The hemorrhagic fevers in general 

with Lassa Marburg and Ebola are the ones we are worried about. 

The first one we have tested now that is shown to be safe and 
44

immunogenic in monkeys is specific for Ebola. We have a secondgeneration one that has been developed in collaboration with the 

Department of Defense, and that is one in which you have both 

Marburg and Ebola in the same construct. So we are working towards having a protection against the threats of hemorrhagic fevers. 

Mr. LINDER. Is it time for us to start thinking about classes of 

drugs as opposed to one drug for one bug? 

Dr. FAUCI. That is an extraordinarily good point, and in fact, that 

is the thinking right now of how we are approaching classes of microbes. We use the terminology, but I want to make sure we do 

that with a caveat, because it is not going to be all-encompassing—

rather a little bit less than universal vaccination and 

antimicrobials. An example of that was recently noted in a 

nonbioterror microbe group B streptococcus, which is an infection 

that fundamentally infects pregnant women, who risk passing it on 

to their newborn infants. There has been a recent important breakthrough conceptually of being able to develop, by expressing all the 

genes of a particular group of subtypes, those overlapping antigens 

that in one vaccine could allow you to essentially have a vaccine 

against all the different types. So that is a first step towards the 

concept of universality, particularly within subtypes of a microbe. 

So we are working in that direction, Mr. Chairman. 

Mr. LINDER. There have been several articles and TV shows lately talking about the risk of avian flu. How does a terrorist take advantage of that? 

Dr. Gerberding? 

Dr. GERBERDING. Well, in this case, Mother Nature herself is a 

very effective terrorist, and we are respectful of her. But we recognize that influenza has some of the important characteristics of an 

excellent threat agent. It is easily transmissible. It is relatively 

easy to produce, and it is easy to modify or engineer. So it does 

have characteristics that, if a person were intent on modifying or 

creating an even worse influenza isolate, it is not beyond our 

imagination to consider that as part of our preparedness efforts. 

Mr. LINDER. Dr. Vitko, you mentioned briefly an actual bioterrorism and countermeasure center. 

Mr. VITKO. Yes. 

Mr. LINDER. The first time that was presented to us, it was going 

to be four labs. Then it was going to be three labs, and now it is 

two labs. What is the most recent iteration of that? 

Mr. VITKO. There are two main centers in there, the BioThreat 

Characterization Center, which does the laboratory experiments to 

reduce the uncertainties in known parameters about the threat and 

improve the assessments; and the second one is the National 

BioForensics Analysis Center, NBFAC, and that does the technical 

forensic analysis. The concept you had heard before, there is a 

broader—NBACC refers both to the center and to the hub programs. And so the other thing you probably heard in that context 

is the BioDefense Knowledge Center, which is in fact in Livermore 

Valley, California. 

Mr. LINDER. I hope we have time for another round of questions. 

My time has expired. Mr. Langevin. 

Mr. LANGEVIN. Thank you very much. 
45

Dr. Fauci, you touched on an issue that I wanted to address. This 

subcommittee had a hearing 2 weeks ago where we heard testimony from bioweapons experts, including Dr. Ken Alibek. And the 

chief concern they all expressed was that we are not ready to rapidly respond to new pathogens, and that known pathogens such as 

anthrax can be easily bioengineered to be resistant to known vaccines that we have in stockpile. Dr. Roger Brent, another one of the 

witnesses, compared the stockpiling of the vaccine to the Maginot 

line, a defense that can be defeated simply by going around it. 

What more can we do and are we doing enough to ensure that 

we could rapidly respond to new pathogens? Is BioShield the way 

to go? Some have suggested that, instead, we focus on developing 

the rapid bug-to-drug capability focused on the ability for rapid 

DNA sequencing of pathogens and quick development and deployment of countermeasures. So can you address that? 

Dr. FAUCI. Yes, I would be happy to, Mr. Langevin. First of all, 

there is a weakness in the stockpiling of a particular countermeasure, a vaccine or an antibiotic, because of the potential capability of engineering around that. But it would be folly to not do 

that at all. To say that someone has the potential of engineering 

a smallpox virus that could elude antivirals—and we don’t have a 

good antiviral—or that could divert the immune response away 

and, therefore, not stockpile a standard smallpox vaccine I think 

would be not a good idea at all. 

Having said that, we should be and are aware of the fact that 

you have to have countermeasures that would address the ability 

to divert bioweapons away from the countermeasures that we have 

already developed. And that is the reason why we are pursuing two 

areas and a third area that answers your last question, and that 

is, multiple antibiotics and antivirals that are against different targets. It is extremely difficult to engineer a microbe in which you 

divert away from virtually every target of an antimicrobial or an 

antiviral without mutating the microbe out of existence. It is not 

impossible, but it is very, very difficult to do. So the more different 

targets you have as the target of your countermeasure, the better 

off that you are. So there is no question about that. 

But the other issue of whether or not we should be looking at 

genomes—this is one of the major efforts at NIH in collaboration 

with CDC of sequencing the genomes of virtually all of the target 

agents, the agents that are suspect of being potential bioterror 

agents, and to literally be able to examine all the vulnerable points 

from both an antimicrobial standpoint as well as multiple overlapping antigens. So I believe that we have to do somewhat of a golden mean: We need to stockpile the things that are obvious, but 

don’t rely just on one vaccine, one bug-or-one drug, one bug, but 

think in terms of the cross-reactivity and the more universal approaches. 

Mr. LANGEVIN. Dr. Gerberding, obviously our ability to respond 

to potential bioweapons attack is going to be largely dependent on 

not only countermeasures but how quickly we are aware of such an 

attack. And we rely heavily on the—in addition to sensors, also the 

public health system. At our visit to the CDC, I had asked you 

about your confidence in real-time information getting to the CDC 

or other government entities in terms of being aware of these po-
46

tential threats or attacks; and you said we had really more work 

to do in the sense that you didn’t give me a feeling that there was 

a high confidence or a robust system in place. Can you share with 

the committee your thoughts on our ability to communicate realtime with the public health system and our ability to respond? 

Dr. GERBERDING. Thank you. In terms of detection, there is variability across the various agents. We have many smallpox false 

alarms now, and our system is very sensitive to the potential for 

a smallpox attack in an individual with a rash or a fever that is 

suspicious. For some other conditions, it is much more difficult because their initial presentation can be subtle, and this is where the 

BioSense system becomes very important. This is our first year of 

funding for BioSense, and by the end of this year, we will have sentinel hospitals and emergency rooms, intensive care units, and laboratories connected from some of the cities involved in our Cities 

Readiness Initiative that are linked to the BioWatch Environmental Protection Program. And, if all goes well by the end of next 

year, we will have all of those facilities and those catchments connected up in real-time so that if someone visits the emergency room 

with something that could be inhalation anthrax, we will have that 

in our system in real-time. 

Internationally, we have a bigger problem. We have seen even 

with the cases of avian influenza that are emerging out of Asia 

now, that sometimes we are seeing a lag of up to 30 days before 

we are aware that a case has occurred. So we have a very, very 

big effort under way to try to decrease that lag time in the international arena. 

Mr. LANGEVIN. And your interaction with pharmacies, you had 

raised the issue that you used to have good reporting from the 

pharmacy network, and now that is not as robust. Could you share 

that with the committee? 

Dr. GERBERDING. Yes. For a while, we were able to receive information I think from about 80 percent market share across the 

country of over-the-counter purchases for certain conditions like influenza. That system has become more expensive than we can afford, so we are replacing it with a different mechanism for getting 

information about purchases. We believe that our ability to collect 

them through billing records and through other pharmaceutical resources is going to improve. 

We also currently—I want to acknowledge our Department of Defense partners here, because right now today we are getting realtime information from the Department of Defense and the VA medical facilities around the country that includes visits, procedures, 

diagnoses, and other critical indicators. Because those facilities are 

so geographically distributed, they are already providing somewhat 

of a sentinel map that proved to perform very well during last 

year’s flu vaccine shortage. 

Mr. LANGEVIN. Is there something you need from this Congress 

with respect to pharmacies and the reporting that they could do to 

you? 

Dr. GERBERDING. Let me get updated on that this week, and I 

will get back to you for the record. Thank you. 

Mr. LANGEVIN. I see my time has expired, but I want to thank 

you all for your testimony. 
47

Dr. GERBERDING. Thank you. 

Mr. LINDER. Mr. Shays is recognized for 5 minutes. 

Mr. SHAYS. Thank you, Mr. Chairman. 

In the work that I do in my national security subcommittee that 

we have oversight of Defense, State Department and Homeland Security, and all agencies that interact on terrorism, we had a hearing with noted medical scholars, and one ran a major medical magazine. And he concluded the hearing by saying—and this was pre9/11—he concluded the hearing by saying: Congressman, I wanted 

to share my biggest concern. His biggest concern was, he said in 

so many words, that a small group of dedicated scientists could create an altered biological agent that could wipe out humanity as we 

know it. 

I want you each to react to that statement in these terms: Is it 

something that concerns you? Is it something that is a fear without 

justification? And so on. 

Dr. GERBERDING. I think you are asking us to imagine the unimaginable. Technically, we know it is relatively easy these days to 

engineer and reengineer agents. So the technical obstacles are relatively trivial. What is challenging is the distribution of those 

agents in manners that would bypass our capacity to recognize and 

intervene effectively. And I think we are still somewhat confident 

that, for many of the pathogens, the capability of causing mass destruction is limited because of the nature of the agent and the limitations of distribution. However, as we said when we were concerned about smallpox preparedness, there are certainly opportunities to distribute or reengineer a smallpox virus that could certainly cause terror. It doesn’t take very many casualties to upset 

our economy and to cause major disruption in our society. 

So I think these are things that we as Federal agencies need to 

and are imagining, and we are doing all of the things that we as 

scientists can do to try to stay one step ahead of the terrorists in 

this regard. It is a big challenge. 

Dr. FAUCI. My response, Mr. Shays, is not significantly different 

at all from Dr. Gerberding’s. Technically speaking, you can do almost anything with a microbe. The real question is, will you end 

up with a microbe that functionally can do the things that the concerned person that you are hearing said, namely, essentially wipe 

out everyone from the face of the earth? Again, that is conceivable—anything is possible. However, it would be very, very difficult 

to do that, extraordinarily difficult, even in the best of hands to not 

only do the engineering to get a microbe that has the characteristics, but be able to spread it in a way in which it has virulence, 

transmissibility, and the ability to spread in a sustained, transmissible way. Not impossible, but very, very difficult to do. 

General SCHOOMAKER. Sir, first of all, I would be foolish to try 

to elaborate on what my distinguished colleagues who are really 

experts in this area have said already. 

Mr. SHAYS. But do you basically agree with their points? 

General SCHOOMAKER. Yes, sir. I would add that the U.S. military has always been concerned conceptually about this notion—to 

draw on something that Dr. Gerberding talked about already, that 

nature is doing on a continuous basis to us, and that we have to 

be prepared in our military role to be able to respond or to antici-
48

pate virtually any bio-event that is out there that Soldiers, Sailors, 

Airmen, Marines, and Coast Guard might encounter. So we go back 

to reinforcing I think the whole interagency cooperation and need 

to understand the immune system, to understand the biology of 

these bugs, and to have a rapidly responsive method of handling 

that. 

Mr. VITKO. I basically agree with the statements made prior to 

me, especially those of Dr. Fauci, on the real difficulty of functionally engineering an organism to accomplish what you want in a 

radical way. 

With that said, there are smaller steps that can be done in engineering organisms. And the question is, how big a step are you trying to make? And in the case that we worked out the strategy with 

HHS and DOD for engineered threats we tried to build in our best 

guesses, estimates, at the difficulty of engineering in certain traits 

and a strategy for getting there. So, for example, antibiotic resistance to a single drug is much more easy to introduce than antibiotic resistance to multiple drugs than making a total de novo 

kind of pathogen that has a desired set of properties. 

Mr. SHAYS. My time has clearly run out, but let me just say for 

the next round of questions when we get there: Going through the 

Soviet Union, you would see pathogens that they would store, 

whether they were threats to animals or humans, they would justify in some cases by saying we don’t know, when the perma-frost 

goes, what kind of biological agents we will deal with. 

But having said that, I would like to in next round ask you to 

respond to all the potential viruses and so on that are stored by 

colleges and research firms that we may not even have a good 

sense of. So that will be in my second round. 

Mr. LINDER. Dr. Christensen is recognized for 5 minutes. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. And I very much 

appreciate your having this hearing, and I hope that we will leave 

here with a clearer understanding of who does what and be able 

to get some answers to our concerns, with so many agencies involved and research for biologic countermeasures and our preparedness for bioterrorism, as to why we are moving still so slowly, it 

seems to me. 

I guess I would start my questioning with General Schoomaker, 

and but others can answer. If I went through the testimony correctly, there are four new labs coming on line at CDC, maybe two 

at NIH, and then the one at Fort Detrick. What I want to know 

is which lab does what? Are we duplicating efforts here? Do we 

need a new lab, given that we have labs at CDC and NIH and they 

are creating more—which, what is the responsibility of each of 

these labs, and are we duplicating effort? 

General SCHOOMAKER. No, ma’am. I think that is a legitimate 

concern, and it is one that has been expressed. I would say that 

every one of the labs, as I think has been outlined, has a different 

role in this chain of custody of both understanding the basic science 

and of the immune system of the human and potential host, as well 

as the microbes that we are dealing with, and then moving those 

good ideas and that basic laboratory science through a test and 

evaluation system which tests safety and efficacy to production. 

And, between threat analysis and anticipating what agents are out 
49

there to the science that is required to understand these agents 

better and the immune system of the host, to test and evaluation, 

that for USAMRIID is one of our core competencies, the ability— 

Mrs. CHRISTENSEN. So you do test and evaluation of the basic 

science that is developed at NIH? 

General SCHOOMAKER. In the context of what we are talking 

here, ma’am, in the protection of the public, U.S. public against 

these hazards, I would say, yes. We have basic scientists that are 

addressing militarily relevant concerns. But for this, one of our 

major contributions at USAMRIID is that we are a large laboratory 

with a great experience, expertise, as well as facilities to test aerosolized agents and to test the effectiveness of vaccines or other 

agents that would be used to ameliorate those. 

Mrs. CHRISTENSEN. Dr. Fauci? 

Dr. FAUCI. I just might add that we certainly don’t need an unlimited amount of BSL4s. I think the plans we have now will likely 

meet the needs for the foreseeable future. The NIH does not have 

a BSL4 on its campus. The NIH is building a BSL4 up in Fort 

Detrick in order to do the kinds of research that are part of our 

expanded plan of research. And literally, the time needed in that 

facility would not be able to accommodate what we were doing at 

the same time as what the Department of Defense is doing up 

there. The BSL4 that is being built in Hamilton, Montana in a laboratory is going to meet the needs of the critical mass of scientists 

who are now working on biodefense there, and then obviously there 

is a very important facility at the CDC which Dr. Gerberding will 

address. 

Mrs. CHRISTENSEN. Dr. Gerberding, could I ask you a question so 

that I can get it in and you can answer both? You say that in your 

statement that, after the decision is made, the supplies that treat 

the countermeasures can get to any location in our country within 

12 hours. In the intervening 12 hours, between the event and the 

time the supplies get there, what level of preparedness is the public health system at right now in terms of containing whatever the 

event is, treating the immediate effects, controlling the spread, and 

then to distributing or applying whatever is sent from the stockpiles? 

Dr. GERBERDING. Let me speak to the laboratory question first. 

One of those buildings that I showed you is housing for BSL laboratories that CDC has desperately needed. Right now we can’t simultaneously work on Ebola and smallpox, but we need to be working on those and some other agents that need those labs. But what 

is exciting about the Fort Detrick campus is not just the agencies 

coming together and co-locating; it is the scientific synergy that can 

be created by bringing people with the variety of expert capabilities 

together to work collaboratively. This is the era of big science, and 

getting the right critical mass of the very best minds in the country 

together to contribute their unique capabilities to these problems 

is, in my opinion, essential. I mean, it has also allowed us to look 

at some gaps. For example, CDC’s role in this campus is to be focusing in on environmental microbiology, which speaks to the question you asked, your second question about what happens in the 

first 12 hours. If we have a contaminated environment like occurred here in Congress in 2001, the science around: How do you 
50

define the extent of contamination, and how do you ameliorate that 

contaminant, and how do you know you have done it, and how 

clean is clean, and when is it clean enough? Those are questions 

that we desperately need scientific answers to, and these are the 

kind of things that we think, by taking advantage of the aerosol 

lab and the forensics capabilities that Homeland is building and 

CDC’s unique microbiologic science capabilities, we ought to be able 

to get to those answers faster. That also is predicated under the 

assumption that we will engage the EPA and the other agencies 

that have primary leadership in these areas. 

Mr. LINDER. Mr. Simmons, you are recognized for five minutes. 

Mr. SIMMONS. Thank you, Mr. Chairman. 

And I thank the distinguished panel made up of medical doctors 

and Ph.D.s—I think all four of you have at least your Ph.D. or your 

medical degree, so congratulations, even the general, yes, indeed. 

The chairman made the comment earlier about prevention; there 

is a lot of talk about identifying problems and responding to them 

in a proper way, and that is entirely appropriate. As the Chairman 

of the Intelligence and Information Sharing Subcommittee of this 

committee, my interest is in identifying the threat capabilities, and 

then trying to prevent these attacks from taking place in the first 

place. 

Clearly, the United States intelligence community plays a role in 

this, certainly in threat assessment, in determining capabilities, 

but then more importantly, and perhaps more difficult, determining what the plans and intentions may be. 

My first question goes to the issue, do each of you or all of you, 

in your current capacity, provide requirements to and get products 

back from the U.S. Intelligence Community at a classified level 

that is useful to you in attempting to determine the threat and to 

prevent an attack? And I will follow that with a second question 

while you consider the first. 

The al-Qa’ida handbook, which is a translation of an al-Qa’ida 

document that was taken in Manchester, England a couple years 

ago, makes reference to public sources. And the al-Qa’ida guidance 

is, use public sources openly and without resorting to illegal means. 

It is possible to gather at least 80 percent of information about the 

enemy from public sources. They go on to mention books, magazines, newspapers, periodicals, official publications and broadcasts. 

It occurs to me that open sources of information lend themselves 

particularly to this area, because so much of what we know about 

research and development in medicine is shared through professional journals and books. And let me give you an example. 

Pfizer Corporation is currently looking into the use of aerosols for 

diabetes treatments so you don’t take a shot through the skin, you 

use an aerosol, but the vaporization is critically important for the 

system to work. It is my understanding that the same vaporization, 

or the technology of that vaporization, can be used in a biological 

weapon that would be airborne, and perhaps dispatched in a theater, a building’s air conditioning system, subway system, train or 

any close space. 

To what extent do any of your agencies go into the open source 

with a red team mindset to see what, in fact, the bad guys might 

be looking at to use to develop and spread biological agents; to 
51

what extent are you using open sources to develop your intelligence 

assessments? 

Dr. GERBERDING. Let me address your first question first, and 

then I guess come around again. 

CDC is linked into the intelligence community in several ways. 

We have more than one FBI agent who is permanently stationed 

at CDC, and we are very closely allied with the regional FBI Center in Atlanta. We have reciprocal training. We have trained more 

than 8,000 local public health and law enforcement officials 

through our combined forensic epidemiology program so that we 

can investigate at the local level. 

But we also have analysts at CDC. We are coming online with 

a data stream so that we will have primary source information, 

and we are also working with the Department of Defense on being 

a note in the medical intelligence information that the Department 

of Defense is creating. 

So we have a number of systems that are likely to be operational 

when we move into our new headquarters building on September 

12th. That is one of our deadlines for getting these systems interoperable. 

Dr. FAUCI. Just to amplify a bit, at the NIH, which does a lot 

of the research involved, we have several taps into intelligence that 

help us direct development of countermeasures. We are in close collaboration with the CDC and their plug into the intelligence community. We rely heavily on the material threat assessments that 

come from the Department of Homeland Security. And we all have 

top secret security clearance and get briefed on a relatively regular 

basis by the CIA and the FBI. 

General SCHOOMAKER. Sir, one linkage to the intelligence community, as these others have said, the Medical Research and Material Command, in fact, the whole of the DoD is linked with the 

DIA, Defense Intelligence Agency, as well as the Armed Forces 

Medical Intelligence Center, which is a joint command. It is collocated at Fort Detrick with MRMC. In fact, to go back to a theme 

that Dr. Gerberding brought up, the critical mass of people working 

on these and sharing information, the design of this campus is, in 

fact, especially made so that it shares information. We do have a 

very close linkage with the Armed Forces Medical Center. 

As far as aerosolization is concerned, and the risk, our people at 

USAMRIID are national, international experts on aerosols, I would 

like to take your question for the record and get back to you on 

that. 

Mr. SIMMONS. Thank you. 

Mr. VITKO. Our information analysis analysts work very closely, 

as you have heard in previous testimony, with the FBI, CIA, NCTC 

and other agencies. They have constructed a multi-agency intelligence team to support the risk assessments when doing material 

threat assessments. We make use of both that formal intelligence 

information, and we provide them cues and products to look for 

from the bioterror characterization activities that we do, but we 

make extensive use of open source information in doing the material threat assessments that we undertake. So we think it is a very 

important source. 

Mr. SIMMONS. I thank the Chair. 
52

Mr. LINDER. Mr. Dicks is recognized for 5 minutes. 

Mr. DICKS. Thank you very much, Mr. Chairman. 

Mr. Vitko, can you walk us through the process of developing a 

material threat assessment? 

Mr. VITKO. It would be my pleasure, Congressman. 

Material threat assessment starts with selecting agents that 

might be of significant concern. The next piece that you do is you 

try to—it is intelligence in form, that is, what do we understand 

about potential adversaries and their capabilities, but then it 

moves on to the scientific process of trying to establish the feasibility of a terrorist constructing a weapon. 

So we start asking questions about how would they obtain an organism, to what level could they grow it out, what resources would 

it take, is it storable; how would you disseminate it; what are the 

potential scenarios; how long does that agent then survive in the 

environment or the food processing or water processing kinds of 

system it goes through, and it takes that through to the consequence end. 

Throughout that, in each of those stages, we involve the appropriate experts. So typically in a material threat assessment, there 

are 40 to 50 experts involved. There are typically, again, two interim reviews, and then a final review and vetting at both an unclassified level and a classified level. 

Mr. DICKS. Do any of these entities represented here by Dr. 

Fauci, Dr. Gerberding and General Schoomaker, are they involved 

in this, or is this your people—

Mr. VITKO. Absolutely. 

Mr. DICKS. So do you have a collaborative—

Mr. VITKO. This is not only multi-agency, it involves the academic community, it involves the entire—

Mr. DICKS. Is that why it takes so long? We have only done four 

of these. I am told that there are about 60 possibilities for material 

threat assessments. Is that correct, is the list that long? 

Mr. VITKO. Well, the 60 agents that you told about are the CDC’s 

category A, B and C list. Clearly some of those are higher priority 

concern than others, that is why they are—

Mr. DICKS. I assume you are doing the higher priority first? 

Mr. VITKO. We are doing the higher ones, and we have essentially finished the category A agents. The reason it takes so long 

is because, if you look at each of these—and there are typically, as 

I described, 30 to 40 parameters in trying to assess the consequences of this kind of event, if I am off even by a factor of two 

in each of those, I can have large uncertainties in what comes out 

in the end. We try to pinpoint that down as well as we can—there 

are still uncertainties—and we try to reduce that and to develop 

a consensus understanding in the community around that. 

Mr. DICKS. Now, one of the things we heard at our last hearing 

was that, because it is becoming so easy to bioengineer pathogens 

for vaccine resistance, that stockpiling of vaccines may not be the 

right approach. One of our witnesses likened the vaccine stockpile 

to the Maginot Line of World War II, which the German Army simply went around. They suggested that we focus on developing bug 

to drug capability. What advice do you have for us on this? I mean, 

we have been upset that maybe you are not getting these material 
53

threat assessments over to DHS, and then they can’t use the 

money in the BioShield Fund to go out and get various drugs as 

countermeasures. 

Some people suggest that that may not be the right approach. 

What can you tell us about this? 

Dr. FAUCI. I think we need a balance of multiple approaches, 

which we are implementing, Mr. Dicks. We certainly need to stockpile vaccines for the obvious threats, and smallpox is one of them. 

We are also keenly aware of the theoretical possibility of being able 

to engineer a microbe to evade vaccine, linked to a mechanism, for 

example, of suppressing the body’s immune system. 

So to say one or the other I think would not be the appropriate 

response, but to do a reasonable amount of stockpiles for the obvious, but don’t think that you are now totally protected, but direct 

your research to be able to circumvent attempts to get around 

the—

Mr. DICKS. Dr. Fauci, you have a lot of experience and people 

have a lot of confidence in you. Are you concerned about the pace 

of getting these material threat assessments done and getting commitments made out of the BioShield Fund? Does this worry you, or 

do you think we are on a reasonable pace here? 

Dr. FAUCI. I am not satisfied, Mr. Dicks. I am aware of how difficult it is, as articulated by Dr. Vitko about getting them out, and 

I think we will soon be getting significantly more out. But I agree 

with you that there is concern about getting it so that we can then 

steer our research and development efforts—

Mr. DICKS. The companies are particularly concerned, one about 

liability, one, that the bigger companies won’t be involved because 

they can make more money doing other things—we watch those 

every night on television—and that they are concerned about the 

pace of the commitments made by DHS, and they are basically 

pointing the finger at Dr. Vitko and his people and saying they are 

not getting these material threat assessments done. 

Until DHS gets it, they can’t take any steps. In fact, there was 

one on radiological that I am told that went over there and was 

sent back. And there was a lot of confusion about where it stood. 

So this is worrisome to us because we don’t have the same kind 

of resources here that we had in Nunn-Lugar and some other 

things, and somehow we have to encourage and move the process 

a little more rapidly. 

Dr. FAUCI. I agree, Mr. Dicks. There are a couple of issues that 

you brought up, I will very briefly address them. 

I agree there is a concern, and we need to move faster and do 

better about getting them out, and DHS is clearly addressing that. 

They are very well aware of that. 

The other is—

Mr. DICKS. I should have said HHS, excuse me, they are the ones 

that have to spend the money out of the Biofund. 

Dr. FAUCI. We have to spend the money out of the BioShield. 

That is my concern because we want to get it out there and get 

those countermeasures out. 

But the point you made about the big companies is something 

that we at the Department, particularly Secretary Leavitt, are concerned about, and are trying to address: how do we better 
54

incentivize the larger companies to get involved? The mechanism 

we have in place now has been helpful, but we really need to do 

better to get them involved. Liability is clearly one of them that 

you mentioned, and this is an issue of very intensive discussion at 

the present time. 

Mr. DICKS. Even the smaller companies are worried about liability. 

Dr. FAUCI. Everybody is, but if you want to get the big players 

in, they have much more to lose than the others. They don’t want 

to step on ground that is going to endanger a large enterprise. 

Mr. LINDER. The time of the gentleman has expired. 

The gentleman from Texas is recognized for 5 minutes. 

Mr. MCCAUL. Thank you, Mr. Chairman. This is really a followup to Mr. Dicks’ question. 

Four of the 60 material threat assessments have been done. 

What is your timetable for completing the 60, and would do you 

favor, as he mentioned, immunity from liability for the big pharmaceutical companies to get them incentivized to participate? 

Mr. VITKO. I will speak to the timetable. We have done material 

threat assessments, three more assessments are in their final review. We will have done 29 agents by January of 2006 in terms of 

risk assessments. Those are not full material threat assessments, 

those are risk assessments, so in some cases there may be additional details to be pursued, and that is where the pace of that is. 

Mr. MCCAUL. Do you need additional resources to speed up the 

process? 

Mr. VITKO. Actually, we have the financial resources. This is a 

question of having the right people and the time it takes to do that, 

but thank you very much for the offer. 

MR. McCaul. I don’t know if it is an offer—

Dr. FAUCI. The debate for liability protection is up for some considerable discussion, you can go all the way to one side, have complete indemnification for everything—that I think would be a hard 

one to sell—but better than we are doing now with regard to liability. I think there is universal agreement that we need to address 

the liability issue better than it being addressed currently. 

MR. McCaul. There is more out of curiosity. I assume most of 

you read the Hot Zone way back when. I read it again about a year 

ago, and the first couple of chapters are really a page turner, and 

scary. The person comes down with the Ebola virus, it is a 

Marburg strain, I think, and begins hemorrhaging on the airplane. 

When are we going to have a material threat assessments for that 

agent? 

And secondly, have we ever weaponized—has it ever been 

weaponized, either by us or the Soviets? And I don’t know if you 

can answer it in open hearing. And is there an airborne strain to 

that virus that we know of today? 

Mr. VITKO. I will speak to the first part—

Mr. LINDER. Let’s not have the answer in open session. 

Mr. MCCAUL. I will withdraw the question. Perhaps I can get 

that information in a closed hearing. 

Then lastly, we passed the faster and smarter funding bill in the 

House, and that provided grants for First Responders. But as I understand it, DHS does not have—or HHS, I should say, does not 
55

have a similar mechanism for bioterrorism grants. My State of 

Texas always ranks dead last per capita, along with New York and 

California on that type of funding. Would you recommend—what 

are your thoughts on changing that formula to a risk-based formula for bioterrorism grants? And perhaps, Dr. Gerberding, maybe 

your expertise. 

Dr. GERBERDING. Thank you. It is a dilemma to assure that we 

have a network of protection in every location in the country and 

yet pay attention to the places where the risk may or may not be 

greater but the impact is large. And certainly in urban areas like 

New York City, we know that the impact factor is huge. 

I always harken back to anthrax when I remember the night 

that I stayed up all night with the City of Fort Collins, Colorado 

when there was a white powder in their post office. That is probably not a city that would rank high on the threat assessment 

scale, but it was a community that had exactly the same requirements as any other anthrax-exposed community. 

I think one of the things that we have done this year through the City Readiness Initiative is to dedicate some—more than $30 

million to a set of 20 cities plus the D.C. area to invest in much 

more depth in countermeasure delivery and some of the additional 

linkages between the environmental assessment capabilities, the 

laboratory and our ability to deliver countermeasures. So that’s a 

step towards focusing on higher threat environments. And I know 

Secretary Leavitt is looking very closely, working with the stakeholders in these communities to determine what is the right balance between a seamless network and yet assuring where people 

would be experiencing the most impact that we have the best preparedness possible. 

Mr. MCCAUL. Okay, thank you. I will yield the balance of my 

time. Thank you. 

Mr. LINDER. The gentleman from Mississippi is recognized for 5 

minutes. 

Mr. THOMPSON. Thank you very much, Mr. Chairman. 

Dr. Fauci, I am looking at a document relative to biodefense 

countermeasures, and I see anthrax is listed on here; and it says 

that we have a new vaccine tested and procured under the project 

BioShield; is that correct? 

Dr. FAUCI. That is correct. The contract was signed for procurement. The payment for that is upon delivery to the Strategic National Stockpile. The work that is going on with the recombinant 

protective antigen, which is the next generation of anthrax vaccine, 

is safety studies in phase one, and now going into phase two, as 

well as work in an animal model, to determine if you can protect 

with your vaccine against an aerosolized challenge. 

Mr. THOMPSON. Can you tell me, how old is that contract right 

now? 

Dr. FAUCI. The contract was signed within this past year, so it 

was in 2005 that it was signed. 

Mr. THOMPSON. Can you tell me the rationale for giving the contract to a company that had never produced the vaccine? 

Dr. FAUCI. This was a decision at the Department, but I would 

be happy to—that was not my decision, but I would be happy to 

address it. 
56

The rationale is that this is under a typical classical contract bid 

procedure where the proposals and response to Request For Proposals are examined and rated and prioritized, and the contract is 

let on the basis of a rating and ranking among the competing entities that put contract proposals in. 

We are dealing with a very unusual situation, Mr. Thompson. If 

we were to exclude now any company that would engage in a BioShield procurement who has not developed a vaccine, we would exclude most everyone who would be interested in doing that. 

Mr. THOMPSON. Well, then I understand there are a number of 

companies who have produced this anthrax vaccine that we didn’t 

select. So using your rationale, if we have companies who do it, 

why would we choose a company that has never produced a vaccine? 

Dr. FAUCI. That gets into the contract law of prioritization and 

the decision that is made on what the factors are in having a procurement officer decide that one is better than the other, and I 

don’t think it would be appropriate for me to address why one got 

it versus the other, that gets into contract law that I am a little 

bit concerned about making a statement about why—

Mr. THOMPSON. Let me tell you why; because in the process of 

awarding the contract, we went out and bought some vaccine from 

another company just to have some around. 

Dr. FAUCI. Right. 

Mr. THOMPSON. And I am trying to figure out the logic of going 

out and buying some vaccine from one company and ordering some 

from other company that has never produced it. 

Dr. FAUCI. Right. I cannot give you the precise answer for that, 

but I can create a scenario that is very compatible with what you 

just described. 

You have a vaccine that you want to improve upon, and you sign 

a contract for the development of a vaccine that you could have in 

your stockpile that is better than the current vaccine, but during 

the developmental process of that new vaccine, there is a gap of not 

having enough on hand of a vaccine that may not be the optimal 

vaccine, but at least it is a vaccine that you could use as a stop 

gap. That could have been the rationale that the Department used. 

And as I mentioned, that was not my decision because I do the research, I don’t do the procurement. 

Mr. THOMPSON. Well, you produced a document saying it was 

done, and that is why I raised the question. 

Dr. FAUCI. I appreciate that, Mr. Thompson, but I am trying to 

explain how that got in there. 

Mr. THOMPSON. Do you know of any other vaccines that have 

been similarly situated? 

Dr. FAUCI. When you say similar situation, you mean—

Mr. THOMPSON. That we have had to go out and procure a vaccine from another source and we contracted with another source to 

produce it. 

Dr. FAUCI. Well, what we are dealing with right now in the biodefense arena does not lend itself to vaccines that have already 

been made for a particular microbe. The other one that is amenable 

to vaccine protection would be smallpox, that is the other example 

with anthrax. We had a smallpox vaccine, we had an anthrax vac-
57

cine. We were down to virtually no doses, 18 million doses of smallpox vaccine. The companies that originally made it were long out 

of the business of making smallpox vaccines, so that would be the 

other example, so there are really only two. 

I would might also add, Mr. Thompson, that the rPA vaccine and 

the AVA vaccine for anthrax are really two different vaccines, they 

are not the same. One is the supernatant of the anthrax which contains all of the antigens. The rPA was the purified component. We 

wanted to go with the more purified component. One, it was very 

likely it would require less immunization doses to get us where we 

wanted to be, and the other, there was the concern about issues, 

be they verified or not, about the baggage associated with the safety of the original anthrax vaccine. 

Mr. THOMPSON. Thank you, Mr. Chairman. 

Mr. LINDER. The chairman recognizes the gentleman from Louisiana for 5 minutes. 

Mr. JINDAL. Thank you, Mr. Chairman, thank you for calling this 

hearing. 

I want to thank the witnesses. I have had the privilege of working with at least two of them before, so I want to thank you for 

taking the time to come and talk to us today. 

I had three broad areas that I wanted to ask questions in, we 

may not have time to get to each of them, but I want to share with 

you the three questions and give you each a chance to respond. 

The first was, on one of his last days as working as the Secretary 

of Health and Human Services, Secretary Thompson talked about 

the fact that he was somewhat surprised we haven’t yet to see an 

attack on our food supply chain, given the vulnerabilities. I would 

like your response to that assessment, whether you think we have 

taken steps, significant and enough steps since September 11, 2001 

to secure our food safety from a by bioterrorist attack. 

The second is—and I know they are not mutually exclusive, but 

the second is, how do we set priorities when it comes to preparing 

our public health infrastructure from the threat of a bioterrorist, 

a man-made attack, versus a naturally-occurring pandemic, and 

which do you think is more likely to actually occur in a short-term 

horizon over the next few years? 

And again, I know they are not mutually exclusive. The ideal answer is it would take and build defenses there to protect our Nation from both. 

Third, and finally, I remember all too well how we didn’t have 

a robust, comprehensive surveillance system on 9/11 for a bioterrorist attack, how we had many local county health units that 

didn’t have 24-hour, seven-day-a-week communications ability, and 

I know we have come a long way since then. 

I would like your assessment, given BioWatch, the Global Disease Detection Initiative and some of these other things, and I 

know CDC is involved with many of these things, how close are we 

to getting real-time information? And within that, if you could comment on the fact, the development of sensors that could give us 

real-time data instead of just 24 hour data. 

And again, I know I have asked a lot of questions, and I would 

appreciate your comments on any part of those three during the 

time that we have got. 
58

Dr. GERBERDING. I will try to give short answers and if you need 

more detail we can get back to you for the record. 

With respect to food safety, I will speak from the CDC perspective. Our role is primarily the surveillance of events potentially related to food-borne problems; and second, obviously safe food handling, the so-called Farm-To-Table initiatives on which we collaborate with FDA and USDA. 

We have made a lot of progress in food safety. The FDA could 

tell you about the enhanced food inspection systems, the food laboratory system that is now part of the linkage into the Laboratory 

Response Network. 

At CDC, we have a system called Pulse Net, and we have been 

able to decrease the time from contaminated food to detection and 

public health response sequentially over the last several years by 

using methodologies that are based on fingerprinting of the agent 

and comparing those in the database of CDC, so that if there is a 

hamburger problem and the case is in Colorado and there is a case 

in New Hampshire, we have the fingerprints collected centrally and 

can immediately say that shouldn’t happen, there must be a point 

source outbreak going on here. 

With respect to the likelihood of bioterror versus mother terror—

mother nature as a terrorist—I think the fact is we have to prepare 

for both. And one of the things I have the most confidence in right 

now is, from a CDC perspective, the investments that we are making in terrorism preparedness are serving us very well across the 

State and local health system for ordinary threats. 

This past year I visited Orange County Health Department. They 

described to me in very explicit terms how helpful the smallpox 

preparedness planning process was in dealing with the flu vaccine 

shortage this year. In Pennsylvania, we heard stories about how 

preparedness efforts have led to a much more rapid immunization 

program when there was a food-borne hepatitis A outbreak detected in a community. And on and on again, the public health benefits from these investments are paying off every day for people 

from ordinary health problems, but each one of those is also an exercise, and every time we use these capacities to deal with a health 

threat, we have the opportunity to improve. And that is part of, I 

think, the answer to your last question, which is that preparedness 

isn’t all or none, it is a process. Just when we achieve milestones, 

we have the responsibility to imagine the next challenge and to 

continue to move in that direction. 

So our Biosense program, the real-time surveillance capacity is 

doing just that this year, creating the linkages to the health system 

so that we are not talking about a daily or weekly, or worse, handwritten reports of events, we are getting them as they occur and 

as people seek medical attention or through the BioWatch system, 

before human exposure occurs and we are still dealing with it at 

the environmental or the prehealth threat stage. 

A lot of work, these investments have made a big difference, but 

they require sustainability, and we have a lot more work to do. So 

we are making progress, but there is more on our plate. 

Dr. FAUCI. Just very briefly, with regard to the food supply, 

many of the food-borne pathogens are part of the category B and 
59

category C of the CDC agents. So on our research agenda, we do 

address those with countermeasures. 

If you would note on my last slide, the map I show is global examples of emerging and reemerging diseases. I agree completely 

with Dr. Gerberding, we don’t consider separately deliberately 

emerging and naturally occurring. And in our infrastructure, our 

intellectual capital and the research we do, our regional centers of 

excellence are called Regional Centers of Excellence For BioDefense 

and Emerging Infectious Diseases. So we think it just makes total 

sense to consider them as a group. We worry about both of them 

and we address them in very similar manners. 

Mr. JINDAL. My time is expired, but I just want to thank the witnesses for your service, and thank you for appearing here today. 

Mr. LINDER. The gentlelady from California is recognized for 5 

minutes. 

Ms. HARMAN. Thank you, Mr. Chairman. 

This is a very capable panel. It gives me great comfort—and I 

worry a lot about potential attacks on our country, it gives me 

great comfort to hear them and to know the progress that they are 

making, individually and collectively. 

You and I and several others went to Atlanta about a month 

after 9/11 to a dilapidated old place called the Centers For Disease 

Control. What a dump, it reminded me of my public high school in 

Los Angeles, World War II bungalows, wiring on the outside, police 

tape across rooms where the ceiling had caved in, refrigerators in 

the hallways, I mean, just a mess. And I am thrilled to see the reinvention of CDC, which is clearly, to me, the tip of the spear in 

the effort to fight and get a handle on bioterror. If the CDC doesn’t 

work, we are never going to make all this work. 

But I want to congratulate Dr. Gerberding and also thank her for 

making a visit very early in her tenure to Harbor-UCLA in California, a public health service hospital, which is one of the premiere trauma centers in Los Angeles County, but also one of the 

premiere teaching hospitals in the country, and I really appreciated 

that. 

I want to continue where Dr. Christensen left off. She was asking 

about the public health network. And it seems to me, as good as 

you all are and as much as you can find out, if we don’t have treatment centers and research centers and centers that can identify 

diseases when they walk in the door or arise nearby, we still don’t 

have the capability we need. So my question is about our public 

health network and how good is it, what other help does it need, 

what should we be doing, and how does it mesh with the cutting 

edge research that all of you do. 

Dr. GERBERDING. Thank you. I think it is important to emphasize 

that our network is only as strong as its weakest link. And we 

started in the hole. It wasn’t just the CDC that was dilapidated, 

we are dealing with a public health system that, for many decades, 

had been woefully neglected, and it is going to take a long and sustained effort to bring it up to contemporary 2001 standards. Global 

connectivity and speed are the requirements of our thinking these 

days. 

I will, however, say that the progress has been incredible. I think 

we have health departments that have been revitalized. We are 
60

learning a lot from success stories. I visited the State of Nebraska, 

they have an exemplary preparedness program there which deals 

both with the rural as well as the urban issues. 

One of the things we learned there was that leadership from the 

top in the State is essential to success. If the governor is engaged 

and you have competent people at the various positions that our 

agencies all represent, you have a much greater chance of having 

a good network in that community. So our job is to try to identify 

what is the performance. And with our new grant that we are just 

starting this year, we will have, for the first time ever, a performance-based approach to measuring what is working, what is not 

working, not to blame or name or shame, but for us to say there 

is a problem here, this place is not able to perform this level of preparedness, it is CDC’s job to go in and diagnose the problem and 

offer treatment and assistance and technical support. 

So I can’t show you the results of the performance-based approach yet because we are just at the very beginning phases of it, 

but I think this is going to help you and this committee and others 

at the State and local level understand what is going well, what 

isn’t going well, where should we preprioritize, but also get those 

lessons learned to move outside of the jurisdiction. 

I think we made a mistake in some of these areas of investing 

in some things 50 times. There were some things that probably 

could have done better in a regional or centralized manner with 

less investment and more expeditious dissemination, and we are 

trying to find those things and reallocate those investments in 

ways that are more helpful so that the local and state governments 

can concentrate on the things that are uniquely problematic for 

them, or where unique local and state solutions are imperative. 

It is a tremendous compendium of progress, but it is also a very 

sobering reflection of where we need to go next. 

Ms. HARMAN. Any other answers? My time is just about up, but 

I appreciate it. 

General SCHOOMAKER. I will just make one comment. 

For most of what we talked about today, the Department of Defense and my command is in support of main efforts that our interagency partners obviously are leading in. But in this one regard of 

public health, it should be important to remind people that the Department of Defense has responsibility for 8.6 million beneficiaries 

of healthcare, both as Soldiers, Sailors, Airmen, Marines, and 

Coast Guard, but also their families and retirees. And we are making every effort that you have heard here today to do real-time surveillance to look out for the public health. 

And I think in the last decade we have made tremendous inroads 

by substituting, just as military does, we have an expression we 

substitute knowledge for mass on the battlefield, and we are substituting knowledge for mass on the battlefield of public health as 

well through the electronic medical record, rapid information exchange, and the like. 

Ms. HARMAN. Thank you. Thank you, Mr. Chairman. 

Mr. LINDER. The gentlelady from the District of Columbia, you 

are recognized for 5 minutes. 

Ms. NORTON. Thank you very much, Mr. Chairman. 
61

Dr. Fauci, you spoke, I think appropriately, of being prepared for 

the obvious threats first. We know there are all kinds of next generation threats BioShield will have to deal with and the rest. I am 

very concerned about obvious threats. Of course, this is a city that 

had to deal with large numbers of people who were threatened with 

and died from anthrax, where this very campus was the central 

focus of the only large-scale attack of its kind in our country. 

I draw some comfort from knowing—I learned even at another 

hearing—of the work being done on anthrax. My concern, very 

frankly, is whether we are really—are we getting ahead of ourselves? We, in another committee, for example, had to deal with—

Dr. Gerberding knows about this, the shortage of flu vaccine. This 

is a matter we have lived with for decades. You talk about being 

unprepared, the notion of being unprepared for something as obvious as what to do if something goes down, that happened to us in 

the flu vaccine. It did not inspire my confidence, as I sat in yet another committee and thought, really not about the flu, but thought 

about BioShield, about anthrax, about smallpox. 

I want to ask two questions, one goes to anthrax. You mentioned, 

Dr. Fauci, obvious threats, and the other goes to smallpox. I want 

to know whether or not, with the drugs you have now, given the 

fact that we have already had an anthrax attack, whether you believe we would be prepared to disseminate drugs and deal with an 

anthrax attack. Particularly, I am interested in closed areas, such 

as the Metro. 

Then I want to ask about smallpox. Who can forget the brouhaha 

with which the administration announced that, beginning with 

health care workers, we are going to make sure that people were 

vaccined against smallpox, it was a very real danger, big announcement. I never saw anything stop in its tracks more quickly than 

that, I can’t find traces of what is happening. I need to know about 

that because in your testimony, Dr. Fauci, you talk about increases 

in the usable smallpox vaccines since 2001, aggressive acquisition 

program, more than 300 million doses. 

Now we have got all these doses, there was this huge announcement by the administration of a program, what is the use of getting 

doses, announcing a program, and at least I can’t find the link between what you say now exists and the program that was announced a couple of years ago. So I would like to ask about those 

two obvious threats, and how close we are to being able to do something about them in an event of an attack—not a futuristic attack, 

not a next generation attack, but perhaps the most obvious threat 

that we face today. 

Dr. FAUCI. Thank you, Ms. Norton, and I will try to address that, 

and I think it is important to distinguish between smallpox vaccine 

that is available in anticipation of an event in which you try to get 

a certain relative proportion of individuals who might be first responders vaccined. 

You recall correctly that what the Department had originally put 

out was a goal that we did not reach, but a degree—

Ms. NORTON. We never got past the first responders, in fact, we 

never got through the first responders. 

Dr. FAUCI. Right. And Dr. Gerberding will answer that aspect of 

it. But before I hand it over to her, I just want to mention that 
62

when you think in terms of having doses available, were there a 

disseminated smallpox attack, you would likely have not seen any 

reluctance of people getting vaccined, which gets to the research 

point of the modified vaccinia Ankara. The next-generation smallpox vaccine , which thus far was considerably experienced in safety, has very few, if any, adverse events associated with that. 

So what we are doing, as I mentioned in my statement, we are 

moving to get stores of that, as the next generation, at the same 

time having enough smallpox vaccine in the strategic national 

stockpile, were there an event to be able to vaccinate everybody. 

The response of preparedness I will hand over to Dr. Gerberding. 

Dr. GERBERDING. Thank you. I will try to be quick on this. 

If you remember the smallpox preparedness program, it wasn’t 

just about vaccinating people, it was about getting laboratories able 

to diagnose, it was about educating several million clinicians on 

how to detect a case, and several other elements of preparedness 

that were quite successfully achieved. One of the lessons that we 

learned from that is that when you are dealing with something 

that is at low but not zero risk, but really high consequence, you 

have to help people understand more effectively what is the rationale for it. Why would we invest—and particularly in this case, 

when our very careful monitoring determined some risks from this 

vaccine that had never been picked up before, despite all the decades that we used it to protect our kids in the past. 

So when you are engaging in the Pre-event Immunization Program that has hazards, the balance has to be very carefully articulated, and I think we could have improved our ability of engaging 

clinicians in the public in this process before we went forward. 

We immunized almost 50,000 people. Since that time, we have 

invested about $37 million in key cities, including the District, to 

try to make sure if we had a smallpox attack, we have a system 

that can get that vaccine that is in your stockpile to the arms of 

the people within 48 hours, and that is what we are working on 

right now. D.C. is not there yet, I can tell you right now, but we 

are working very hard with these investments. CDC just assigned 

a senior manager to the health department in Washington, D.C. to 

help improve our ability to handle our—

Ms. NORTON. When do you envision you will start again to try 

to enlist first responders, nurses, doctors and the like? 

Dr. GERBERDING. Each community, including the District, makes 

its own decisions about what is the plan for administering vaccines, 

how many people need to be vaccinated, who should they be, and 

it is really their decision based on their distribution plan in the 

community, how many pre-event, how many during event and how 

many post event. 

The Secretary and all of us in the Department right now are 

working on plans to augment our ability to do that so that the Federal Government can help and not expect each community to carry 

the full burden. 

Ms. NORTON. I thank you, Mr. Chairman. 

I just want to say that if you think that local jurisdictions on 

their own are going to proceed, even given the educational effort, 

without considerable prodding from the Federal Government to go 

ahead, if you think they should be ready now, I am here to tell you 
63

that I think without some reassurance from you at CDC that now 

is the time to go ahead, this program is not going to start—

Dr. GERBERDING. No, I agree with you. That is part of the investment and the reason we are putting the money there because we 

think that sends a message which is important. That is why we 

have performance measures so that we can verify whether performance has improved. And it is why, in the case of the D.C. area, we 

are specifically assigning one of our best managers to come in locally and really help get this on the road because we recognize this 

is a high threat community. 

But I agree with you completely. We can’t sit in Atlanta and 

Washington and make pronouncements, we have to get out there—

Ms. NORTON. Nor can you say that each local jurisdiction go 

ahead when you want to; you have to push it. 

Mr. LINDER. The time of the gentlelady is expired. 

Mr. Markey is recognized for 5 minutes. 

Mr. MARKEY. Thank you, Mr. Chairman. Welcome. 

In April of 2005, I wrote to both CDC and the Department of 

Homeland Security about the accidental shipment of the H2N2 flu 

virus to thousands of laboratories and health care facilities. The 

H2N2 virus was the flu virus that caused the worldwide flu epidemic, pandemic that killed 1 million to 4 million people between 

1957 and 1958. 

While all the samples have reportedly been accounted for, the responses provided by CDC and DHS raised some serious questions 

regarding both policy and the degree to which CDC and DHS are 

coordinating their efforts. 

When I asked the Department of Homeland Security whether the 

H2N2 flu samples could be used as a biological weapon, the Department of Homeland Security stated that ‘‘if these materials fell 

into the hands of terrorists, they could be used as a biological 

weapon.’’ When I asked the Department of Homeland Security 

whether they had evaluated their laboratories and screened the individuals that have access to this virus, DHS stated that this job 

belonged to the CDC select agent program, the program for Ebola, 

the program for the most serious virus. 

But CDC’s response to my question stated that CDC decided not 

to include the H2N2 flu strain on the select agent list in the first 

place. 

My first question, Dr. Gerberding, do you agree with the Department of Homeland Security’s conclusion that H2N2 could be used 

as a biological weapon? 

Dr. GERBERDING. Our opinion is that virtually any infectious disease could be used as a biological weapon. Influenza was not on the 

select agent list, that was a decision made by a group of experts 

who were looking at not just can something cause disease, but can 

it be weaponized and does it meet the other criteria—

Mr. MARKEY. What was your conclusion? 

Dr. GERBERDING. The conclusion at that time was not. One of the 

things that is not commonly recognized about H2N2 is that the H2 

is new, but the N2 is something that we have been experiencing 

for the last several years. So, in fact, the true threat associated 

with that particular experience was probably not nearly as great as 

we had been describing in our anticipation of making sure that we 
64

absolutely had recovered it because we have population immunity 

to the N2 component. 

Mr. MARKEY. When the CDC is evaluating whether to include 

something on the select agent list, is potential use as a biological 

weapon considered? 

Dr. GERBERDING. CDC does not make the decision about what is 

on the select agent list, that is a decision that is made by an interagency working group of the Federal Government, which includes 

the U.S. Department of Agriculture and NIH and the CDC—

Mr. MARKEY. When the CDC is making its recommendation, does 

it include as part of its recommendation whether or not it can be 

used as a biological weapon? 

Dr. GERBERDING. That is the criteria for a select agent. 

Mr. MARKEY. So is there a disagreement between the Department of Homeland Security and CDC on its inclusion? 

Dr. GERBERDING. I would defer to Dr. Vitko, because I don’t 

know what the Homeland Security position was on that committee. 

Mr. VITKO. I wasn’t around for the committee. The point is, we 

believe that—I don’t have the detailed response that you have in 

your hand—but I believe there is another paragraph on there that 

also states that it is a question of quantity and the way it is released, so yes. 

Mr. MARKEY. Well, in the Department of Homeland Security response to my letter on the H2N2 virus, the Department of Homeland Security repeatedly stated that the CDC Select Agent Office 

was responsible for monitoring those who have access to the virus 

and other matters. Did you know that H2N2 wasn’t even on the select agent list in the first place? And if so, why did your agency 

continually refer me to the office in charge of regulating the select 

agents back at CDC? 

Mr. VITKO. It must have been an error. 

Mr. MARKEY. Well, it appears that there is a regulatory black 

hole that sits right in the middle of these agencies on this issue, 

that is, that on something that is so contemporary, this flu virus, 

and so potentially dangerous if it could be used, that there should 

be, at this point, given the fact that it is now 4 months since I 

wrote the letter, that some kind of a resolution of the issue was 

reached, and some kind of coordination that was established between Homeland Security and CDC over a subject where there appears to be a difference of opinion in terms of how this agent could 

be used on bioterrorist organization. 

Dr. GERBERDING. I can’t speak for what was in the Homeland Security letter, but the process that Congress has defined for us in 

making these decisions is to, first of all, make a determination that 

a pathogen belongs to a select agent list using a set of criteria. 

Once an agent is on the list, it is CDC’s job to do the appropriate 

steps to assure that people who are using that agent have security 

clearance and are using the appropriate containment procedures in 

their laboratory. So had this virus been on that list, CDC would 

have been responsible for the laboratories that were used it as a—

Mr. MARKEY. I understand that, but getting it on the list now is 

obviously something that is difficult to comprehend because of this 

regulatory black hole that exists. For example, the Bird Flu Virus, 
65

or SARS, or any other highly infectious virus, have they been 

added to the being select agent list? 

Dr. GERBERDING. Highly pathogenic avian influenza viruses are 

on the select agent list as defined by the USDA list of select 

agents. 

Mr. MARKEY. They are on the select agents. 

Dr. GERBERDING. The viruses that are capable of causing 

pandemics and fall into the avian group are on the list. 

Mr. MARKEY. Have you solicited the Department of Homeland 

Security’s views on whether these viruses—

Dr. GERBERDING. The Department of Homeland Security is represented on an expert committee that makes the determination, as 

are the other Federal agencies that have a stake on this. 

Mr. MARKEY Thank you. 

Mr. LINDER. We would like to get a few more questions, if the 

panel can stay around for a few more questions. I think we will 

vote in about 15 minutes. I just have a couple of questions. 

Going back to the labs, how many level 4 labs are there in the 

country? 

Mr. VITKO. Level 4 labs in the country? I actually don’t have that 

answer. I will defer to Dr. Fauci on that. We did a survey on 3 and 

4, we issued a biocontainment report in which there are several 

hundred at the 3 or 4 level, but only a dozen or so at the level 4 

level. Not even that, less than that. 

Mr. LINDER. Are we building more? 

Dr. FAUCI. Currently there is the CDC, there is the BSL4 at 

USAMRIID. There is a BSL4 in Galveston. So those are three. 

There is one that is being constructed at Rocky Mountain Labs in 

Hamilton, Montana. There is one that is being constructed at Fort 

Detrick at the NIH in conjunction with the United States Army. 

And then there are planned BSL4s, one in Galveston and one in 

Boston, and they have not begun yet. The one in Galveston just 

broke ground in May of 2005, the one in Boston is scheduled to 

break ground in December of 2005. 

Mr. LINDER. But at what point do we build enough labs that they 

start to cannibalize the other labs they have because of limited scientific knowledge we have in this country. 

Dr. FAUCI. I am sorry? 

Mr. LINDER. At what point do we begin to cannibalize the other 

labs that currently exist because of the limited number of scientists 

at this level in the country? 

Dr. FAUCI. You say the other laboratories—

Mr. LINDER. New labs will wind up taking scientists from the old 

labs. 

Dr. FAUCI. Yes, okay. I understand. I didn’t quite get it the first 

time, I apologize. 

The question is a reasonable question. If you have scientists that 

are involved in biodefense, are you drawing them out from other 

areas of research that are important to the Nation? And the answer is, whenever you are gearing up in a new area that requires 

scientific expertise, certainly there is a draw off to some extent. 

But in other experiences we have had, such as with HIV/AIDS in 

which we had to draw from the microbiological and infectious diseases community, it really turns out that it normalizes reasonably 
66

quickly, where you get more people involved in a field, and although initially there may be some drawing off of people who 

would otherwise have been working on something else and now 

working on biodefense, at the end of the day it tends to equalize 

itself because you get quantitatively more people in the field as opposed to just diverting from one to the other. 

So there is the initial component of what you are talking about, 

but what we hope to do is enhance the amount of intellectual capital involved in all emerging and reemerging infectious diseases 

with the ability to go back and forth between deliberately emerged 

or bioterror agents or agents that we absolutely still need more 

people for where they are naturally occurring. 

General SCHOOMAKER. It might also be worth just clarifying that 

a BSL4 lab is not necessarily a BSL4 lab, there are distinctions 

within the community of BSL4s that have expertise and capacities. 

For example, aerosolized testing evaluation, that is a subset of 

BSL4. So it sounds highly redundant, or maybe competing with one 

another, but there are specialties and specialization within the 

BSL4. 

Mr. LINDER. Dr. Gerberding, in a private conversation you and 

I had we talked about sources of intelligence around the world, and 

you mentioned the use of some of these international corporations. 

I would like you to expand on that for the record and for this committee. 

Dr. GERBERDING. I think that what we are talking about is making use of any available information, particularly in the areas that 

don’t have robust public health systems or don’t have data systems 

that allow health information or event information to come in 

through traditional means. The United States Government has a 

large stake in the health status of these areas because we have 

workers and citizens and businesses that are operational there. 

People on the business sector have a stake in the health of their 

workers and in the health of the communities in which they are 

working. 

So it is very possible that there are health events that could unfold in an area where the business community may be the first to 

recognize that there is a problem, and might be in a position to 

give us a heads-up or to give the local minister of health a headsup that there is something amiss in the community. 

We have no proof that this is a successful strategy, but we have 

strong interests on the parts of several corporations to think about, 

is there a way that this kind of shared interest in health status, 

not just terrorism, but any kind of health event could benefit the 

community, could help be an element of protection for the business 

and could serve as another input or a resource for information 

here. It is a little bit like the open source method of mining things 

that appear on the Internet or reading local reports in newspapers 

and the local press about things unfolding at the community level. 

Again, I have no proof that this is going to be successful, but it 

is something that we want to explore carefully because we certainly 

don’t want to compromise the business interest or send a message 

to their customers in that region of the world that they are there 

for anything other than business purposes. But we live in a global 
67

community, and there are potential situations where this could be 

a win-win for all parties concerned. 

Mr. LINDER. Mr. Langevin. 

Mr. LANGEVIN. Thank you, Mr. Chairman. 

If I could, I know Dr. Christensen touched on this, but so I have 

a more clear understanding, Dr. Fauci, the work that you do at 

NIH and the work that is done at CDC, who does what? Is there 

a duplication of effort between NIH and CDC in this respect? 

Dr. FAUCI. No, there is not, Mr. Langevin. There is a certain degree of complementarity, but there certainly is not a duplication of 

efforts at all. In fact, we very closely coordinate what we do on a 

real-time basis almost constantly, so I really cannot think of any 

examples at all where there is duplication without a purpose of 

complementary nature to it. 

Dr. GERBERDING. I couldn’t agree more. I feel that we have a collaborative relationship. Dr. Fauci and I are often at the witness 

table together for that very reason. But one very specific example 

is that some joint research proposals that CDC had a small amount 

of extra research money that Dr. Fauci’s institute embedded in 

their larger research portfolio, so when the investigator applied for 

bioterrorism infectious resources, it was an NIH grant, but the 

CDC got some of its priority work done through their mechanism. 

So we think that is a good model for demonstrating that we are collaborating and not redundant, and at the same time the investigators who cue up to apply for these resources have the imprimatur 

of an NIH grant. So it is a win-win. 

Mr. LANGEVIN. That is good to hear. 

Now, one of the stated goals of HSPD–10 is decontamination recovery from a chemical or biological attack. Who is the lead agency 

on this, and how is it done? And what types of attacks do you feel 

that we can successfully decontaminate right now? 

And related to this is the issue of quarantining, and what authority do we have to quarantine and who has the ultimate authority on that kind of activity? 

Mr. VITKO. The HSPD–10 in the section on response and recovery gives EPA the overall lead for determining the decontamination 

technology standard and systems approaches to the cleanup. 

In the section on prevention and protection in the critical infrastructures, it lists DHS as the lead for decontamination methodologies for critical infrastructures. So those are the two agencies, with 

the EPA having an overall responsibility. 

Mr. LANGEVIN. And another question. Last winter we experienced a great shortage of flu vaccine which clearly demonstrated 

a weakness in our public health practices, namely that we rely too 

heavily on one flu vaccine maker. Do you have sufficient flu vaccine 

to inoculate the public this coming winter? And on a related point, 

are there lessons learned from this that you will find useful in procurement of other vaccines? 

Dr. GERBERDING. Let me first say many lessons were learned, I 

think, by FDA, CDC and NIH and the rest of the stakeholders in 

last year’s flu vaccine shortage. We will not know how many doses 

of flu vaccine we have until the season is completed because the 

manufacturing process starts imminently and the vaccine rolls off 

the assembly line throughout the season. If everything goes well, 
68

we will have the expected supply from Sanofi Pasteur. We are hoping Chiron will be able to resume their production, although, again, 

until they actually start producing vaccine, we are not counting on 

it. 

Dr. GERBERDING. And we are still working on the international 

sources. We expect a third manufacturer to be newly licensed this 

year for sales in the United States in time for flu season. 

But the lesson we learned, I think the biggest lesson overall is, 

don’t count your chickens until they are hatched. And so we are not 

planning to blast out at the beginning of the season with optimism 

that all of these sources will come through as we are expecting. We 

are going to emphasize immunization of the high-risk groups first 

so that we are sure the people who need the protection the most 

don’t have to stand in line to receive it. 

Mr. LANGEVIN. I see my time has about expired, so I yield back. 

Mr. LINDER. Mr. Shays. 

Mr. SHAYS. Thank you, Mr. Chairman. And thank you all for 

staying for additional time. Mr. Chairman, if this had been my 

committee, they would have been here at 10:00, still here, so don’t 

spoil them, because we are learning so much. 

You are an awesome panel. You are very articulate and you are 

very helpful. And I agree with my colleague Ms. Jane Harman that 

it gives me some comfort to know you are doing what you are 

doing. 

I had asked the question about what is in the refrigerators in the 

Soviet Union, the stuff that they are working on. I have seen it. 

They have strings with wax attached, very poor security, and so on. 

But forget them for a second. I would like you to comment—and 

since I would like to ask a few questions, if you all agree, then we 

will just go to the next question. But the question I have is, should 

we be concerned about some of the viruses, pathogens, whatever 

that may be in research labs, locked up, not properly identified in 

colleges and so on? 

Dr. GERBERDING. I am concerned. I think that the academic culture traditionally has been very open, very collegial, and very focused on research. And we are asking for somewhat of a culture 

change. We are asking our academic partners to be mindful of the 

fact that some of the agents that they are working with are potentially threat agents or, in the wrong hands, could be used or developed as a threat agent, as part of the importance of the select 

agent process, so that people who are working with the select 

agents are registered, inspected, and their security background is 

checked. 

It is not a fail-safe system. And, you know, the trust that has 

been built up over many, many years of successful engagement in 

these infectious disease research activities—and I should say, probably also applies to chem and biothreats in a different realm—is 

one that has worked very, very well when you consider the possibilities. But we need to have a stronger network now. And it is not 

100 percent known what is in the freezer. 

Mr. SHAYS. Does anyone disagree with the answer there? 

Dr. FAUCI. Agree, and that the National Science Advisory Board 

for BioDefense is trying to create just what Dr. Gerberding said, 
69

that culture of responsibility among the people who might have 

these agents. 

Mr. SHAYS. The culture is important, but do we have laws that 

back it up? Can people be sent to jail if they don’t properly label 

and secure these vaccines? 

Dr. GERBERDING. Absolutely. That is the purpose of the select 

agent process. There is the law enforcement component to that 

through the Department of Justice. 

Mr. SHAYS. Just as briefly as you can, give me some comfort, in 

addition to what you said so far, that we are utilizing the resources 

that are already available at every hospital that takes in patients. 

How good is the network, not of new—you know, just within the 

existing facilities? Does every hospital in every State have to file 

information every day to a centralized location in the State? And 

then do you have access every day on, you know, a ‘‘now’’ basis to 

get that information? 

Dr. GERBERDING. No. The only information we currently get from 

the health care delivery system every day is what we get from the 

Department of Defense and the VA. But we will, through the Secretary’s health information technology initiative, which is a major, 

major, major priority of our administration. As electronic medical 

records become available we are creating opportunities to have the 

de-identified information of public health interest automatically 

forwarded to CDC through our biosense mechanisms so that we 

have that real-time, everywhere, everybody, everyday kind of access to health events in our communities. 

Mr. SHAYS. General, you want to answer, but let me make sure 

that you incorporate some kind of answer as to whether there are 

deadlines. 

General. 

General SCHOOMAKER. Sir, I just want to add to that I think we 

are in our relative infancy in this, the connectivity of the different 

elements of the health care delivery system. The Department of 

Defense has shared its expertise and its technology with the CDC 

and continues to do that. We use a program based on syndromic 

events, that is, the recognition of syndromes that are associated 

with known agents that are infectious illnesses, but that I think we 

would all agree right now is still again in its infancy. It is wired 

in with Johns Hopkins University in a program called essence. 

There are improvements coming, and are forthcoming right now. 

Mr. SHAYS. When do you think we are going to see a system that 

just, we have instant data from almost every hospital, health care 

center? When we will have such a system? 

Dr. GERBERDING. For the most useful information, I would say 

we are in a 5-year horizon for being able to do that ubiquitously. 

By the end of this year, we will have that information from critical 

hospitals in most of our major cities; and by the end of next year, 

we will have it from all of the hospitals in those major cities. 

Mr. SHAYS. Fairly instant data? I am sorry. 

Dr. GERBERDING. Real-time data. As the transaction occurs in 

the ER, it will be appearing in our system. 

Mr. SHAYS. Thank you. 

Mr. LINDER. Dr. Christensen. 
70

Mrs. CHRISTENSEN. Thank you. I think I am going to try to follow 

my colleague Mr. Jindal’s lead. I am going to try to get a couple 

questions in. 

One, where does the new chief medical officer of the Department 

of Homeland Security fit into all of this? 

Two, I am glad to hear about some of the research, Dr. Fauci, 

on the agents with broad application. But we had a hearing where 

we heard of some others that seemed to be very promising and 

would be worthwhile considering, such as those that treat radiation 

sickness or stop bleeding. And I wanted to know maybe from Dr. 

Vitko, how do you get them entered into consideration and maybe 

into the stockpile? 

And Dr. Gerberding, just the cuts in your budget, I am still concerned that we are going to find that some of the core functions, 

the infrastructure that has to be there every day, is going to suffer 

while we have the demands on CDC to deal with bioterrorism. 

Mr. VITKO. Okay. I will begin with answering the question on the 

chief medical officer. 

As you heard from me, the portion that I represent in S&T is the 

bioportfolio that basically does the research and development aspects, but we have very little operational responsibility. The chief 

medical officer will come in and have overall responsibility for 

being the medical interface with the other agencies, with HHS, 

USDA. DHS does have some operational assets in that sense in the 

National Disaster Medical System and in the medical—Metropolitan Medical Response System and in coordinating those kinds of 

activities. So the chief medical officer will be the overall interface 

for the agencies. 

Dr. FAUCI. Countermeasures such as those for radiation sickness. 

We just completed our strategic plan and research agenda for radiation, for the money that is coming from the Department in 2005, 

$47 million. A very high priority is how one treats radiation exposure, and in fact, we have been in communication with the company that I believe you are referring to. 

Mr. VITKO. And we have done the material threat assessments 

on both the radiological devices and a special study on nuclear 

weapons, fissile weapons, used in that kind of context, and provided that to the WMD medical countermeasures committee, and 

they are using that in their requirements process. 

Dr. GERBERDING. And with respect to the proposed 2006 budget 

for CDC, our overall preparedness budget has actually increased in 

the proposed budget. What has been cut from our budget are some 

very specific programs. The House mark and the Senate mark, of 

course, are not resolved yet, so we are not really clear where that 

budget will ultimately reside. 

While I think every agency head at this table and any other table 

would always think of good ways to use budget increases, we also 

can do a lot with the budget that we have, and we have got to 

make every one of these preparedness dollars go as far as we can. 

That is why we are putting emphasis on the performance-based investments this year, so we know what we are getting and where 

we need to either invest more or do more to get that network seamless. 

Mr. LINDER. Mr. Simmons. 
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Mr. SIMMONS. Thank you, Mr. Chairman. 

And, again, thanks to the panel. A quick question focusing on Dr. 

Vitko’s testimony. 

Pages 7 and 8, he refers to the Plum Island Animal Disease Center. The Plum Island Animal Disease Center is located in New 

York on Plum Island in Long Island Sound, but most of its professional personnel actually reside in Connecticut and go out to the 

facility on a daily basis by ferry boat—well, all working days of the 

year and all working weeks—under all sorts of interesting and 

challenging conditions. 

I understand from your testimony that there is a recapitalization 

program under way for a next-generation facility, the National Bio 

and Agro Defense Facility. It doesn’t indicate in your testimony 

whether this facility is planned as an upgrade to Plum Island or 

for some other location. And ever since Plum Island left USDA and 

went into Homeland Security, there were rumors that it might 

close and those activities might be moved elsewhere. 

The facility is not a new facility from the standpoint of its installation; it has been around, I think, for 50 or 60 years. But, in fact, 

investments have been made; I have been out to the island several 

times, and it is relatively modern in many of its aspects. 

My question is, in the planning for the upgrades, is that for Plum 

Island or is that for some other location? 

Mr. VITKO. And the answer is, the siting decisions haven’t been 

made on it yet. We are first formulating the programmatic requirements of what we want to accomplish, see whether it can be accomplished within the existing footprint and traded off, and look at 

other options. 

Mr. SIMMONS. And when might we be brought up to date on 

some of those activities? 

Mr. VITKO. The conceptual design studies that are formulating 

those program requirements are just now being initiated, and 

somewhere in mid-2006 we should have the programmatic requirements and the pros and cons of different siting strategies available 

at that time. 

Mr. SIMMONS. Okay. I thank you for that. I mean, I will simply 

say that the people that I have met that work out there are highly 

qualified, very capable, an extraordinary asset and that, of course, 

relocating creates losses. And I hope the people doing the planning 

are aware of that. 

Mr. VITKO. We echo the fact that the Plum Island Animal Disease Center is making major contributions, has and continues to 

make major contributions; the personnel are excellent. And we are 

making progress; right now, even within the existing footprint, we 

are constrained with the space that we have there about how much 

progress we can make on foreign animal diseases just because of 

the facilities. It is possible that it could be expanded there; it is 

possible that we will need to look elsewhere. Those are the options 

that are on the table. 

Mr. SIMMONS. I thank the panel. And I thank the chairman for 

going for the second round. 

Mr. LINDER. We have a 15-minute vote starting. Ms. Norton, we 

still have time for your questions. 
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Ms. NORTON. Thank you very much, Mr. Chairman. I just have 

one question. This is a question for Dr. Gerberding. Again, it is anthrax, an obvious threat. 

I wrote you a letter in—several months ago after a false alarm 

here involving what you may remember to be postal facilities in 

Virginia where they thought there was an anthrax attack. I 

learned for the first time that my own first responders and first responders throughout this region are using biological field detection 

nonlaboratory equipment. 

I have not received a response to this letter. If I could just say 

to all you, when a Member of Congress writes, you just well answer, because any good member will cite this to you as part of her 

questions. And it is not a very good thing not to answer when 

some—if you don’t know the answer, tell them. 

I was really concerned because I found these things being used 

all around. And I said, Well, you get this thing. Who regulates 

these things? Which ones are good? Which ones are bad? And I 

learned after making some inquiries that nobody does anything, 

they just go out and get them if you don’t—people don’t do what 

they have to do if the government doesn’t give them any guidance. 

Now, I learned, however, that you had—you, CDC, had given 

some recommendations to the U.S. Postal Service—of course, perhaps, in light of the fact that they had suffered an attack once—

on the use of these autonomous handheld devices. I don’t know 

that the devices were good or bad during this or had anything to 

do, frankly, with this false alarm. What I do know, or have learned 

since, is that they are being used throughout the country. 

We know that, of course, your certified laboratory response network is the only way to know if there has been an anthrax attack. 

But so do these people know that; and they said to me, Well, in 

coordination with them—and we will always send it to them anyway—we are going to use these things. 

Disturbingly, Dr. Kati Kelley, who is now the President of the 

Association of Public Health Laboratories, testified before the Government Reform Committee—and I am quoting here, and I did in 

my letter—‘‘CDC’s minimal supply of materials to allow testing’’—

she talked about her concerns about CDC’s minimal supply of materials to allow testing for biological terrorism substances. She said 

that you simply didn’t have the—there was a shortage of the critical testing kits at CDC. 

I asked about that, and I asked whether you could do something 

about the proliferation of these handheld devices. I am not suggesting that they are good or bad. I am suggesting that if the government sits back and says—and here, in this case, you actually 

recommended against the use of these biological field detection autonomous nonlaboratory equipment; if you are going to recommend 

against it and if you were not a regulatory agency that is going to 

offer no guidance and they are going to proliferate, leaving it to the 

wonderful free market sector, when they don’t hear you saying anything, they just all produce whatever ones they want to and they 

market to our first responders, then I am left to ask, Well, who in 

the world will—and help us out here. 

If it wasn’t for you to do, particularly after I wrote directly to you 

April 29, I don’t know why—perhaps it was Mr. Vitko—this stands 
73

unanswered. And more seriously unanswered is the opinion or the 

view expressed to the Government Reform Committee in April that 

you, yourself, are very short of critical testing kits, which leaves me 

wondering what would happen here if we had another attack and 

all we had were these hand-held devices which nobody has tested 

or given any guidance or any recommendations concerning. 

So I would like to know those two things: Whether you yourself 

could handle someone sending to you directly from, let us say, various parts of the country, particularly in the event of a simultaneous attack. And why you haven’t given some guidance yourself 

or gone to whoever you think is appropriate to offer guidance. 

And, finally, why didn’t you answer my letter? 

Dr. GERBERDING. Ms. Norton, I can see that people are getting 

ready to vote, so let me try to get the most important. 

Ms. NORTON. I don’t have to vote. 

Dr. GERBERDING. I am trying to answer what I think is your 

most important question. I apologize for being nonresponsive to 

your letter; I will look into why that happened. We generally have 

a good track record of response, as we take congressional letters 

very seriously; and I am personally very sorry that you didn’t get 

good customer service from CDC on this issue. 

With respect to the shortage of reagents for the last—I can assure you that, first of all, that played absolutely no role in the situation in the postal facilities here. We do not have a current shortage, but we are worried that we are able to keep up the supply as 

reagents expire over time. So the planned request in our 2006 

budget appropriation is to correct that. And assuming that our 

budget is, as we anticipate from the current marks in the House 

and the Senate, we will have the resources we need to deal with 

the reagent issues in the future at CDC. 

So that is not a current issue across the United States; it is a 

predicted issue if we didn’t take steps to fix it in the future. 

With respect to what the Postal Service is doing to monitor the 

quality of the air in the postal facilities, I can assure you that the 

USPS has used an extremely thoughtful process. They have evaluated these systems very carefully. And I believe it is the Department of Homeland Security that they are working with. 

There are three sets of these systems in major play that we can 

talk about comfortably in public. There are some other applications 

that would best be discussed out of the public record. One is the 

BioWatch system that you have heard about in our cities; one is 

the system in play in our postal facilities, at the decision of the 

U.S. Postal Service with consultation from DHS and CDC; and a 

third is the system that I believe the military is using in certain 

applications that I again don’t want to— 

Ms. NORTON. I am talking about handheld devices. Are you talking about? 

Dr. GERBERDING. I am talking about the circumstances of the 

scenario that you are describing these past several months. With 

respect to handheld or so-called ‘‘smart ticket’’ types of devices, 

that is an area where CDC explicitly has recommended against 

their use, other than for ruling out a true positive, because they 

are not specific. They are very often misused; we have had numerous false positives with them. 
74

Ms. NORTON. They say it is an extra layer and they are going to 

send it to you anyway. And they want to use them. 

You may be right. What bothers me is, nobody tells—they are 

buying them because you don’t give them any guidance one way or 

the other. 

Dr. GERBERDING. I would disagree. We do provide guidance to 

the Postal Service. 

Mr. LINDER. The time of the gentlelady has expired. 

Mr. VITKO. Let me also join the answer, if I may. 

First of all, CDC has provided that guidance advising against 

them. Second of all, DHS sponsored jointly with NIST a test of 

handheld devices, specifically around anthrax testing the ‘‘smart 

tickets,’’ in which five companies participated, independently run 

by the American Association of Analytical Chemists, that were 

done explicitly for this purpose, to provide an independent evaluation of the product to see whether it could perform—and these 

handheld detectors might be useful against powders, not against 

testing surface contamination or hemispheric contamination, but 

against powders—and to test their validity. 

And the test results of that are available. And so a process has 

been set up with an independent third-party agency, this respected 

testing agency to do that. 

Third is, I mentioned to you that these joint five agencies have 

joined on this coordinated biomonitoring memorandum of understanding, and part of that, they are establishing equivalency processes. And we have also begun a discussion with industry for an 

approach to make available for them the high accuracy—more importantly, high specificity—assays. 

The real issue with the handheld assays or with anything that 

you use in a commercial device is, does it have the specificity to 

say that this is a threat and not light up on everything else and 

start the whole system ringing? And we are in the process of working that with the—there is an industry consortium called the— 

Mr. LINDER. Dr. Vitko, I actually do have to vote. And if you 

have more to say to her, you can send her a letter. I want to thank 

our witnesses for their expert testimony. It has been very, very 

helpful. This is new ground for us, and we are grateful. 

And, without objection, the hearing is adjourned. 

[Whereupon, at 4:18 p.m., the subcommittee was adjourned.] 

FOR THE RECORD
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