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H.R. 5498: THE WMD PREVENTION AND 

PREPAREDNESS ACT OF 2010 

HEARING 

BEFORE THE

SUBCOMMITTEE ON EMERGING 

THREATS, CYBERSECURITY, 

AND SCIENCE AND TECHNOLOGY 

OF THE

COMMITTEE ON HOMELAND SECURITY 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

JUNE 15, 2010 

Serial No. 111–70 

Printed for the use of the Committee on Homeland Security 

Available via the World Wide Web: http://www.gpo.gov/fdsys/ 
(II) 

COMMITTEE ON HOMELAND SECURITY 

BENNIE G. THOMPSON, Mississippi, Chairman 

LORETTA SANCHEZ, California 

JANE HARMAN, California 

PETER A. DEFAZIO, Oregon 

ELEANOR HOLMES NORTON, District of 

Columbia 

ZOE LOFGREN, California 

SHEILA JACKSON LEE, Texas 

HENRY CUELLAR, Texas 

CHRISTOPHER P. CARNEY, Pennsylvania 

YVETTE D. CLARKE, New York 

LAURA RICHARDSON, California 

ANN KIRKPATRICK, Arizona 

BEN RAY LUJA ́ N, New Mexico 

BILL PASCRELL, JR., New Jersey 

EMANUEL CLEAVER, Missouri 

AL GREEN, Texas 

JAMES A. HIMES, Connecticut 

MARY JO KILROY, Ohio 

DINA TITUS, Nevada 

WILLIAM L. OWENS, New York 

VACANCY

VACANCY

PETER T. KING, New York 

LAMAR SMITH, Texas 

DANIEL E. LUNGREN, California 

MIKE ROGERS, Alabama 

MICHAEL T. MCCAUL, Texas 

CHARLES W. DENT, Pennsylvania 

GUS M. BILIRAKIS, Florida 

PAUL C. BROUN, Georgia 

CANDICE S. MILLER, Michigan 

PETE OLSON, Texas 

ANH ‘‘JOSEPH’’ CAO, Louisiana 

STEVE AUSTRIA, Ohio 

VACANCY

I. LANIER AVANT, Staff Director 

ROSALINE COHEN, Chief Counsel 

MICHAEL TWINCHEK, Chief Clerk 

ROBERT O’CONNOR, Minority Staff Director 

SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY, AND 

SCIENCE AND TECHNOLOGY 

YVETTE D. CLARKE, New York, Chairwoman 

LORETTA SANCHEZ, California 

MARY JO KILROY, Ohio 

WILLIAM L. OWENS, New York 

VACANCY

BENNIE G. THOMPSON, Mississippi (Ex Officio) 

DANIEL E. LUNGREN, California 

PAUL C. BROUN, Georgia 

STEVE AUSTRIA, Ohio 

PETER T. KING, New York (Ex Officio) 

JACOB OLCOTT, Staff Director 

DR. CHRIS BECK, Senior Advisor for Science and Technology 

RYAN CALDWELL, Clerk 

COLEY O’BRIEN, Minority Subcommittee Lead 
(III) 

C O N T E N T S 

Page 

STATEMENTS

The Honorable Yvette D. Clark, a Representative in Congress From the 

State of New York, and Chairwoman, Subcommittee on Emerging Threats, 

Cybersecurity, and Science and Technology: 

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

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

The Honorable Daniel E. Lungren, a Representative in Congress From the 

State of California, and Ranking Member, Subcommittee on Emerging 

Threats, Cybersecurity, and Science and Technology ....................................... 5 

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

the State of Mississippi, and Chairman, Committee on Homeland Security: 

Prepared Statement ............................................................................................. 39 

The Honorable Bill Pascrell, Jr., a Representative in Congress From the 

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

WITNESSES

Ms. Sara (Sally) T. Beatrice, Assistant Commissioner, Public Health Laboratory Director, New York City Department of Health and Mental Hygiene: 

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

Prepared Statement ............................................................................................. 8 

Mr. Randall S. Murch, Associate Director, Research Program Development, 

National Capital Region, Virginia Polytechnic Institute: 

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

Prepared Statement ............................................................................................. 14 

Dr. Robert P. Kadlec, Vice President, Global Public Sector, PRTM Management Consulting: 

Oral Statement ..................................................................................................... 20 

Prepared Statement ............................................................................................. 22 

Ms. Julie E. Fischer, Senior Associate, Global Health Security Program, 

Henry L. Stimson Center: 

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

Prepared Statement ............................................................................................. 27 

FOR THE RECORD

Submitted for the Record by Hon. Bill Pascrell, Jr., a Representative in 

Congress From the State of New Jersey: 

Chart ..................................................................................................................... 39 

(1) 

H.R. 5498: THE WMD PREVENTION AND 

PREPAREDNESS ACT OF 2010 

Tuesday, June 15, 2010 

U.S. HOUSE OF REPRESENTATIVES, COMMITTEE ON HOMELAND SECURITY, SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY, AND

SCIENCE AND TECHNOLOGY, Washington, DC. 

The subcommittee met, pursuant to call, at 1:04 p.m., in Room 

311, Cannon House Office Building, Hon. Yvette D. Clarke [Chairwoman of the subcommittee] presiding. 

Present: Representatives Clark, Thompson, Lungren, and Austria. 

Also present: Representative Pascrell. 

Ms. CLARKE [presiding]. The Committee on Homeland Security 

will come to order. The committee is meeting today to receive testimony on H.R. 5498, the Weapons of Mass Destruction Prevention 

and Preparedness Act of 2010. Good afternoon. 

The Commission on the Prevention of WMD Proliferation and 

Terrorism, the WMD Commission, put out a report entitled ‘‘World 

at Risk’’ in 2008. In that report they told us that they believe that 

a terrorist act would occur somewhere in the world by 2013 and 

that it was more likely to be an act of biological terrorism. 

Although we have not seen WMD attacks here in the United 

States really come to fruition since 9/11 and the anthrax events of 

2001, the threat is real. We have heard it from the WMD Commission. We have heard it from the 9/11 Commission. We have heard 

it from the intelligence community. We have heard it from law enforcement. We have heard it from the military. We have heard it 

from State and local officials. We have heard it from the private 

sector. We have seen successful attacks occur overseas, and we 

have seen aborted and failed terrorist attempts actually occur here 

in the United States. 

While we continue to reach out through diplomatic channels to 

those who may wish to do us harm, we fully realize that the diplomatic solution may not be possible. Therefore, it is clear that we 

need to enhance our homeland security by improving efforts to 

counter a WMD attack, especially using a biological weapon. 

This is the purpose of H.R. 5498, the WMD Prevention and Preparedness Act of 2010. With this bill we recognize that we will 

need to prevent and deter the threat; that we must prepare for an 

attack if prevention and deterrence fail; that while we are continuing to prepare, an attack may occur that we will need to detect 

before people and animals get sick or injured, or die; that once we 
2 

detect an event, we need to attribute the crime to someone or some 

entity; that we need to respond immediately; that we will need to 

recover from the attack, and that all of these actions are not the 

sole responsibility of the Federal Government, so we need to integrate partners in the public, private, and global sectors. 

We addressed each of these elements—prevention, deterrence, 

preparedness, detection, attribution, response, and recovery—in 

H.R. 5498. 

One of the determinations of the WMD Commission was that the 

Nation has not done enough to counter the biological threat. I 

agree, but I also want to point out that much has been done and 

is being done. 

In H.R. 5498 we take this into account, and authorize and address a number of things that already exist in the Executive 

branch, including but not limited to the National intelligence strategy for countering biological threats, export enforcement for 

counter proliferation, material threat determinations, promotion of 

the Biological and Toxin Weapons Convention (the BWC), 

BioWatch, System Assessment and Validation for Emergency Responders (the SAVER program), the Laboratory Response Network 

for Bioterrorism, training to investigate biological threats and demonstration projects to recover from a biological attack. 

Still, we agree with the WMD Commission that much more needs 

to be done to counter the WMD threat in general, and the biological threat specifically. 

With this in mind, through H.R. 5498, we call for a number of 

new programs and activities, such as the National Intelligence 

Strategy for Countering the Threat from WMD, the creation of a 

top tier of select agents that pose a material threat to the Nation— 

the Tier 1 Material Threat Agents—enhanced measures to better 

secure these Tier 1 Material Threat Agents, grants to help laboratories that possess Tier 1 Material Threat Agents increase their security, sharing laboratory biosecurity information and threat-related information and guidance with State and local officials, reviewing criminal statutes to ensure their application will result in 

the prosecutions we need, a policy review to allow for first responders and others to get immunized for different threat agents as a 

preventive measure before attacks occur, international engagement 

to enhance biodefense and biosecurity, a study of forensic science 

in homeland security by the National Academy of Science, and the 

National Medical Countermeasure Dispensing Strategy. 

Finally, in H.R. 5498, we are looking to fix some problematic programs, such as the National Biosurveillance Integration Center. 

This is a bipartisan bill, developed through careful consideration 

of varying viewpoints and the input of experts and interested parties in both the public and private sectors. 

We look forward to continuing that process with our witnesses 

today, and I thank you for appearing today. 

[The statement of Chairwoman Clarke follows:] 

PREPARED STATEMENT OF CHAIRWOMAN YVETTE D. CLARKE

JUNE 15, 2010 

The Commission on the Prevention of WMD Proliferation and Terrorism—‘‘the 

WMD Commission’’—put out a report entitled ‘‘World at Risk’’ in 2008. In that re-
3 

port, they told us that they believed that a terrorist act would occur somewhere in 

the world by 2013, and that it was more likely to be an act of biological terrorism. 

Although we have not seen WMD attacks here in the United States really come to 

fruition since 9/11 and the anthrax events of 2001, the threat is real. 

We have heard it from the WMD Commission; we have heard it from the 9/11 

Commission; we have heard it from the intelligence community; we have heard it 

from Federal law enforcement; we have heard it from the military; we have heard 

it from State and local officials; we have heard it from the private sector; we have 

seen successful attacks occur overseas; AND we have seen aborted and failed terrorist attempts actually occur here in the United States. 

While we continue to reach out through diplomatic channels to those who may 

wish to do us harm, we fully realize that the diplomatic solution may not be possible. Therefore, it is clear that we need to enhance our homeland security by improving efforts to counter a WMD attack—especially using a biological weapon. This 

is the purpose of H.R. 5498, the WMD Prevention and Preparedness Act of 2010. 

With this bill we recognize: 

• That we need to prevent and deter the threat; 

• That we must prepare for an attack if prevention and deterrence fail; 

• That while we continue to prepare, an event may occur that we will need to 

detect before people and animals get sick or injured, or die; 

• That once we detect an event, we need to attribute the crime to someone or 

some entity, and we need to respond immediately; 

• That we will need to recover from the event; and 

• That all of these actions are not the sole responsibility of the Federal Government, so we need to integrate partners in the public, private, and global sectors. 

We addressed each of these elements—prevention, deterrence, preparedness, detection, attribution, response, and recovery—in H.R. 5498, the WMD Prevention and 

Preparedness Act of 2010. 

One of the determinations of the WMD Commission was that the Nation has not 

done enough to counter the biological threat. I agree, but I also want to point out 

that much has been done and is being done. In H.R. 5498 we take this into account, 

and authorize and address a number of things that already exist in the Executive 

branch, including but not limited to: 

• The National Intelligence Strategy for Countering Biological Threats; 

• Export Enforcement for Counter Proliferation; 

• Material Threat Determinations; 

• Promotion of the Biological and Toxin Weapons Convention (the BWC); 

• BioWatch; 

• System Assessment and Validation for Emergency Responders; and 

• The Laboratory Response Network for Bioterrorism. 

Still, we agree with the WMD Commission that much more needs to be done to 

counter the WMD threat in general, and the biological threat specifically. With this 

in mind, through H.R. 5498, we call for a number of new programs and activities, 

such as: 

• A National Intelligence Strategy for Countering the Threat from WMD; 

• The creation of a top tier of Select Agents that pose a material threat to the 

Nation—the Tier 1 Material Threat Agents; 

• Enhanced measures to better secure these Tier 1 Material Threat Agents; 

• Grants to help laboratories that possess Tier 1 Material Threat Agents to increase their security; 

• Sharing laboratory biosecurity information, and threat-related information and 

guidance with State and local officials; 

• Reviewing criminal statutes to ensure their application will result in the prosecutions we need; 

• A policy review to allow first responders and others to get immunized for different threat agents as a preventive measure, before attacks occur; 

• International engagement to enhance biodefense and biosecurity; 

• A study on Forensic Science in Homeland Security by the National Academy of 

Science; and 

• A National Medical Countermeasure Dispensing Strategy. 

Finally, in H.R. 5498, we are looking to fix some problematic programs, such as 

the National Biosurveillance Integration Center. 

This is a bipartisan bill, developed through careful consideration of varying viewpoints, and the input of experts and interested parties in both the public and private 

sectors. We look forward to continuing that process with our witnesses today. 
4 

Ms. CLARKE. I would now like to ask for unanimous consent for 

Mr. Pascrell, who is not a Member of this subcommittee, to participate in this hearing. 

Without objection, the gentleman from New Jersey, Mr. Pascrell, 

is authorized to question the witnesses and obtain testimony for 

this subcommittee hearing. 

I now yield 2 minutes to the gentleman from New Jersey and the 

sponsor of this legislation, Mr. Pascrell, for an opening statement. 

Mr. PASCRELL. Chairwoman, I want to thank you for yielding me 

as much time, or 2 minutes of yours—I want to thank you for your 

leadership and the leadership of Ranking Member Lungren. He 

and I have been talking for many a moon regarding what we need 

to do to defend the Nation and the Weapons of Mass Destruction 

Prevention and Preparedness Act, H.R. 5498, which Mr. King and 

I introduced last week. Mr. King, of course, is the Ranking Member 

of the entire committee. 

This hearing is critical to understand the necessity for our legislation and to highlight our lack of preparedness at all levels for the 

threat of weapons of mass destruction. I would like to be here 

today to say that the threat of weapons of mass destruction is one 

restricted only to Hollywood thrillers or is a distant reality we need 

not worry about today. This is not the case. 

Let me be clear about the reality. In all that we have read, all 

that we have heard, we can conclude in unison that weapons of 

mass destruction constitute the greatest catastrophic risk we face 

anywhere in the world today. We know from reports that terror 

groups like al-Qaeda remain committed to obtaining nuclear and 

biological weapons. 

The Weapons of Mass Destruction Commission has said that 

under current readiness, a weapons of mass destruction attack is 

likely to occur by 2013. Recent terror attempts, including the incident at Times Square, demonstrate that our enemies continue to 

probe our homeland security infrastructure, looking for weaknesses, probing, probing every day. The message is clear. We need 

to be more than vigilant. 

Let me be even more clear. Either we can pass the legislation 

and be prepared for this threat or we can ignore it, hope that the 

best-case scenario plays out. That is the kind of short-term thinking that BP used for the disaster we see in the Gulf of Mexico. 

The Weapons of Mass Destruction Commission has made one 

thing very clear in the reports, Madam Chairwoman. Almost 9 

years after 9/11, we still do not have a comprehensive National 

strategy to counter the grave threat that weapons of mass destruction pose for our Nation. You referred to this in your opening. 

I am proud to say that the Weapons of Mass Destruction Commission, headed by former Senator Graham and former Senator 

Talent, has endorsed our legislation. That it has a truly comprehensive approach within it to securing the Nation against weapons of mass destruction by looking at all angles—prevention, deterrence, preparedness, detection, attribution, response, and finally, 

recovery. We did it all within 100 pages. 

Madam Chairwoman, I look forward to hearing the testimony 

today, moving forward with the Weapons of Mass Destruction Pre-
5 

vention and Preparedness Act. I yield back and thank you for yielding to me. 

Ms. CLARKE. Thank you, Mr. Pascrell. 

I now recognize the Ranking Member of the subcommittee, the 

gentleman from California, Mr. Lungren, for an opening statement. 

Mr. LUNGREN. Thank you very much, Chairwoman Clarke, for 

your leadership on this critical issue and for your willingness to 

begin this hearing early to accommodate a scheduling conflict I 

have. I have to go be part of a panel to interview the three finalists 

for the job of inspector general of the House of Representatives. It 

was scheduled with four other people, so I can’t change that. So I 

thank you for that. 

The American people face no greater or more urgent threat in my 

estimation than a terrorist attack with a weapon of mass destruction. It is my greatest fear, shared by others, that a WMD would 

be used against our Nation. We have no greater responsibility as 

Members of Congress to protect the American people from such a 

horrific attack and to do everything in our power to try and accomplish that. 

The WMD Commission predicted in 2008 that ‘‘a terrorist attack 

with a WMD weapon is more likely than not to occur in 2013.’’ 

Some people, I think, want to shy away from that, because they 

think that means that it will be a completed or successful attack. 

They didn’t say that. They said that they believe there will be a 

terrorist attack with that weapon. So we have to do everything we 

can to ensure that does not occur, and if it does occur, to minimize 

the damage as best we can and to recover from it. 

The commission also reminded us in last January’s report card 

that the Government’s progress in preventing and responding to 

nuclear biological attack is inadequate, and so much more work 

needs to be done. 

As one who believes that intelligence is our best defense against 

terrorist attack, particularly a WMD attack, I am strongly supportive of Title 1 of the bill, which establishes a National intelligence strategy to improve U.S. capability to collect, analyze, and 

disseminate weapons of mass destruction intelligence. Better intelligence will hopefully prevent such an attack from ever happening, 

which is the only satisfactory outcome. 

We also need to prepare for and recover from such attack. However, my focus will be on prevention. This legislation is urgently 

needed and long overdue. It does provide a comprehensive approach to enhance DHS’ effort to both prevent and deter as well as 

detect, respond to, and recover from a WMD attack. 

While New York City and the New York, New Jersey area is unquestionably a terrorist target, all urban areas in this country and 

critical infrastructure across our Nation could be devastated by a 

nuclear biological attack. We need to understand that. The American people need to understand that this is not just for the New 

York area. This is for the entire Nation. 

As a result, this bipartisan legislation is urgently needed, and I 

look forward to working with both of you and the other Members 

of our committee to enact this legislation. 

I do want to thank our witnesses for their testimony on this legislation—more importantly, for the work that you have done in the 
6 

past and the expert advice that you have given us, we appreciate 

that. We have tried to benefit from suggestions from you and your 

colleagues, and this piece of legislation is a product of that consultation, and we hope it will continue. I look forward to hearing 

your comments. 

Thank you very much. 

Ms. CLARKE. Thank you very much, Ranking Member Lungren. 

We will be joined by our Chairman, Mr. Thompson, shortly, but 

we are going to proceed with this hearing in the interim. Other 

Members of the subcommittee are reminded that under subcommittee rules, opening statements may be submitted for the 

record. 

I would like to welcome our witnesses. Our first witness, Dr. 

Sally Beatrice, is the assistant commissioner and director for the 

New York City Public Health Laboratory. 

Our second witness is Dr. Bob Kadlec, former special assistant 

to the President for homeland security and senior director for biological defense policy. Currently, he is the vice president for the 

global public sector at PRTM. We commend him for his long military career. 

Our third witness is Dr. Randy Murch, who holds a number of 

positions at Virginia Tech, including associate director for research 

program development. Dr. Murch had a long career, as a special 

agent in the FBI, Federal Bureau of Investigation, where among 

many programs, he created the Hazardous Materials Response 

Unit. 

Our fourth witness, Dr. Julie Fischer, is a senior associate at the 

Henry L. Stimson Center, where she leads their global health security program. 

We thank all of our witnesses for being here today. Without objection, the witnesses’ full statements will be inserted in the record. 

I now ask each witness to summarize his or her statement for 5 

minutes, beginning with Dr. Beatrice. 

STATEMENT OF SARA (SALLY) T. BEATRICE, ASSISTANT COMMISSIONER, PUBLIC HEALTH LABORATORY DIRECTOR, NEW 

YORK CITY DEPARTMENT OF HEALTH AND MENTAL HYGIENE 

Dr. BEATRICE. Good afternoon, Chairperson Clarke, Mr. Lungren, 

Mr. Pascrell. I am Sara Beatrice, assistant commissioner of health 

and director of the New York City Public Health Laboratory. 

The Public Health Lab is one player among many local, State, 

and Federal entities comprising the anti-terrorism preparedness 

and response efforts in New York City. It is our duty to provide the 

necessary surveillance and routine surge testing to support emergency preparedness and response for the city. We need the support 

of our Federal, State, and local partners to be able to do this. 

As you know, New York City is a high-threat jurisdiction. Our 

approach to bioterrorism preparedness is not theoretical. We have 

been attacked. We are acutely aware that it could happen again, 

and we in the health department are fortunate to have a mayor 

who understands that public health is an integral part of biothreat 

preparedness and response. 
7 

I thank you for the opportunity to testify today, and I would like 

to share some of our challenges over the past decade that may be 

helpful as you consider legislation to improve the Federal structure 

in support of bioterrorism preparedness and response. 

When the New York City Public Health Lab joined the Laboratory Response Network in 1999, the goal was to establish a laboratory that could detect a bio attack through clinical specimens from 

patients presenting at emergency departments. Instead, the anthrax attacks of 2001 revealed itself in both clinical and environmental samples. 

We were prepared to receive a few specimens. We received thousands. Our Federal partners came to our aid with six tons of supplies and personnel to perform testing and to train our staff. Within a week the New York City laboratory was able to handle hundreds of environmental and clinical specimens a day. 

An initial increase in Federal support in 2002 gave us the ability 

to build a highly robust biothreat response laboratory. Unfortunately, while the threat of another attack has not decreased, funding has been reduced with each fiscal year. Even with the added 

resources of the Urban Area Security Initiative funding, it is a 

challenge to maintain the level of excellence established by 2003. 

One-time and interment funding are helpful, but not sufficient to 

maintain our capability. 

We strongly support section 2135 of the bill, which will provide 

funding for Laboratory Response Network activities, and we appreciate the bill’s authors for recognizing this need. We urge you to 

consider the necessity for consistent and sustained funding for the 

long term. 

BioWatch is an excellent example of a well-intentioned program 

that was implemented without sufficient funds to address the true 

needs of this program. Basic funding for technologists, reagents, 

and equipment was the extent of Federal funding for the laboratory. What wasn’t funded was a comprehensive quality system to 

ensure the consistency of reagents and the training and competency of staff performing the testing, nor was there funding to 

ensure quality and consistent testing across jurisdictions, and nor 

was the cost to set up and maintain infrastructure of the local laboratory provided. 

Also, clear roles and responsibilities for the Federal, local, and 

contracted entities involved in the BioWatch program need to be 

better defined, and jurisdictions need centralized Federal guidance 

for consequence management planning in the event of a BioWatch 

actionable result. 

I am sure this committee is well aware of the consequences of 

unreliable BioWatch results, and I want to thank the office for recognizing the need for additional financial support in section 2132 

of the bill. 

I also have some concerns about section 2104, which redefines a 

set of Tier 1 agents that required enhanced security. Again, I cannot overemphasize the importance of appropriate and sustained 

funding to support the enhanced biosecurity that will be required 

of facilities that handle these agents. 

An additional concern is intergovernmental information sharing. 

The public health community believes biodefense needs to address 
8 

both intentional and accidental releases of biological threat agents. 

Local and State public health agencies need to have access to detailed information related to the biological agents and biosafety 

programs at each laboratory regulated by the select agent program 

in their jurisdiction. At this time this information is not shared locally. 

It is our hope that the information required by sections 2105 and 

2107 will be shared with State and local health departments to 

mitigate and respond to select agent incidents in laboratories within the locale. 

While I have limited my comments to issues related to the New 

York City Public Health Lab, the city would like the opportunity 

to both provide more detailed comments on the entire bill, reflecting the concerns of all of our key emergency response agencies. We 

stand ready to assist the committee to develop and implement 

these critical initiatives. Again, thank you for the opportunity of 

testifying here today. 

[The statement of Dr. Beatrice follows:] 

PREPARED STATEMENT OF SARA (SALLY) T. BEATRICE

JUNE 15, 2010 

Good afternoon, Chairperson Clarke and subcommittee Members. I am Dr. Sara 

T. Beatrice, Assistant Commissioner of Health and Director of the New York City 

Public Health Laboratory (NYC PHL), a Bureau of the NYC Department of Health 

and Mental Hygiene (DOHMH). Thank you for the opportunity to testify on H.R. 

5498, the ‘‘WMD Prevention and Preparedness Act of 2010.’’ 

The NYC PHL provides quality laboratory testing services that are needed by 

NYC DOHMH and its partner agencies, and our city’s laboratory and health care 

community as they respond to clinical and environmental public health concerns. 

The NYC PHL has been a member of the Laboratory Response Network (LRN), an 

international network of laboratories able to respond quickly to public health 

threats and emergencies, since its inception in 1999. New York City has been a 

member of the BioWatch pathogen detection program since it was deployed in 2003, 

and is working with our Federal partners in the assessment of new technologies and 

quality systems for this program. I am going to describe some of our challenges and 

experiences of the past decade in the hopes that it may be helpful to you as you 

consider legislation to improve the Federal structure and support of bioterrorism 

preparedness and response. 

New York City is a high-threat jurisdiction. Our approach to bioterrorism preparedness is not theoretical; we have been attacked several times, and we are acutely aware that the city is a likely repeat target for terrorists. There will always be 

a need for significant bioterror response laboratory capacity and capability in the 

city to ensure our ability to rapidly and effectively respond to an event caused by 

the dissemination of a biological threat agent. In 1999, the NYC PHL received its 

first Centers for Disease Control and Prevention (CDC) grant to establish a biothreat response laboratory (BTRL). The first BTRL consisted of a single room situated in the middle of routine testing laboratories. Security was basic; there were 

padlocks for the evidence locker and a punch-code door lock at the entry. Later, the 

room access was upgraded to swipe card control and video surveillance was added. 

Reagents and resources were minimal; formal training was limited to one CDCfunded person attending a course on methods of agent identification at the CDC. 

In short, the NYC BTRL was a one-room space staffed by two laboratorians trained 

in standard safety methods for routine bacteriology work. There was only basic supporting infrastructure—there was no secure specimen receiving area, no secure computer database, no dedicated sample accessioning system, no standard report functions. Samples were delivered directly to the BTRL by first responders and tested 

for a collection of agents, and hand-written reports were sent to describe the results 

of the microbiological testing. All procedures were manual. There was no capacity 

for high throughput or Polymerase Chain Reaction (PCR) testing at that time. When 

the laboratory first became operational, the FBI submitted only approximately one 

specimen per month. 
9 

In October, 2001, on the same day that the index case of cutaneous anthrax was 

confirmed, law enforcement delivered a Bacillus anthracis-contaminated letter received at NBC by Tom Brokaw’s staff. The BTRL sample load rapidly multiplied 

from a baseline of 10 samples in the previous year to hundreds of samples per day. 

Within days, the BTRL was transformed. Six tons of supplies were flown in from 

the CDC. Staffing went from two to 75 laboratorians, including staff from CDC and 

the Department of Defense (DOD). Rapid, molecular testing was brought on board. 

Dedicated space was increased by almost twenty-fold and included 10 laboratories, 

evidence rooms, support and storage areas, and a command center. Databases and 

computers were brought in and standardized testing protocols were developed. 

New York City has received funding from several sources for biothreat preparedness activities. CDC’s Public Health Emergency Preparedness (PHEP) Cooperative 

Agreement provides funding to the NYC DOHMH, and a portion of this funding is 

allocated by the DOHMH to the PHL. However, PHEP funding is increasingly dedicated to specific initiatives, and is decreasing with each fiscal year. Public health 

agencies receiving PHEP funding were authorized to use this support to enhance 

responses not only to bioterrorism but to other intentional and unintentional incidents that could evolve into public health emergencies. 

The Urban Areas Security Initiative (UASI) provides funding, through the Department of Homeland Security (DHS), to the city of New York. UASI funds are allocated annually by the city to programs, including the PHL. Procurement of an AllHazards Receipt Facility (AHRF) was funded with $1.5 million from UASI. This facility was deployed to ensure that unknown samples could be screened for hazards 

(i.e.: chemical, radiological, etc.) before entering the laboratory. An AHRF is considered a safety necessity; however, many jurisdictions will not have adequate funding 

for this purpose. 

PHEP, UASI and city funding has enabled the NYC BTRL to develop into its current iteration. The city is fortunate to have a mayor who understands that public 

health is an integral part of biothreat preparedness and response, and Mayor 

Bloomberg has provided significant city tax levy monies for laboratory infrastructure. NYC dedicated $20 million of city capital funds to renovate the BTRL and 

Mycobacteriology laboratories after we were unsuccessful in getting Federal capital 

funding for this essential project. This included a biosafety level 3 (BSL3) facility 

necessary for working with highly infectious organisms. Security upgrades were included as well. Physical barriers keep unauthorized vehicles from entering the PHL 

premises. There is 24-hour police presence in the building, which is enhanced when 

necessary, and extensive closed-circuit security system was installed in the building. 

We believe that Federal mandates for biosecurity enhancements must be Federally funded. While the BTRL has moved far beyond a one-room operation, there are 

upgrades and required maintenance to facilities, equipment, and instrumentation 

that we struggle to finance because external funding falls short, and the city and 

State dollars used to make up the difference are becoming increasingly scarce as 

well. 

Today, many of the samples received by the BTRL are suspicious substances, such 

as unknown powders, that are found in envelopes or other packages. The samples 

are submitted by local (NYPD) and Federal (FBI) law enforcement and originate 

from a variety of places. In 2009 and 2010 the laboratory has tested suspicious substances from many locations, including banks, financial businesses and organizations (37 percent), governmental organizations (courts, transit, law enforcement 

agencies, 26 percent), embassies, consulates, diplomatic missions and the United 

Nations (26 percent), and hospitals, media organizations, and other businesses (11 

percent). New York City is unique in that considerable portions of the NYC PHL 

budget are utilized to test samples which are collected from locations such as diplomatic missions and consulates that are considered ‘‘foreign soil’’. 

Our Federal and local partners, including in particular the NYPD, are responsible 

for responding to incidents involving suspicious substances and assigning a risk 

level to the event based on predetermined criteria. A decision is made whether testing is appropriate, and a priority is assigned to the sample. Many samples arrive 

at the PHL at the end of the work day and may require evening and weekend testing, and the overtime adds additional pressures on our budget. Maintaining a group 

of trained and competent on-call staff that can effectively respond 24/7 to a surge 

in sample volume is challenging. 

If a suspicious substance were submitted and tested positive for the presence of 

a Select Agent, an immediate and significant environmental investigation would be 

launched, resulting in a surge of sample collection and confirmatory testing similar 

to that experienced during the 2001 anthrax event. We need to build and maintain 

a stable infrastructure of staffing, state-of-the-art testing methods, and a cache of 

reagents available to seamlessly move into a surge mode at any time. The NYC 
10 

DOHMH, and the PHL in particular, recently challenged and proved the soundness 

of our system during the H1N1 outbreak of 2009. However, without adequate, consistent funding for staff, training, instrumentation, and reagents, this capacity will 

not be sustainable. We strongly support section 2135 of H.R. 5498 which would provide funding for LRN activities, and we appreciate the bill’s authors for recognizing 

this need. 

NYC’s involvement in the BioWatch program has been more substantial than in 

any other jurisdiction. Beginning in January 2003, NYC participated in the first deployment of BioWatch, a limited array of air collectors designed to detect the airborne release of select biological agents. The laboratory assays used in BioWatch 

were derived from those developed by Lawrence Livermore National Laboratory 

(LLNL) and CDC for the Biological Aerosol Sentry Information System (BASIS) program. During the initial BioWatch deployment in NYC, the BASIS mobile laboratory was deployed for approximately 2 weeks to NYC, assisting PHL staff to process 

and analyze BioWatch filters pending completion of the PHL BioWatch laboratory. 

When the BASIS laboratory staff left NYC, much of the testing equipment remained 

at the PHL to help initiate the establishment of this laboratory. 

Soon thereafter, PHL recognized that additional support would be necessary for 

the BioWatch laboratory to become fully functional and self-sufficient. Instrumentation, reagents, informatics and staff, not accounted for when the program was established, would be needed. To assist PHL during this period, LLNL provided equipment and supplies directly from LLNL ‘‘push packs’’ (instrument and reagents required to do the testing) and dedicated staff were hired through the CDC. 

PHL continued developing relationships with our Federal partners during the 

next 12 months and embarked on the first of many pilot programs to enhance the 

capability and capacity of the NYC BioWatch laboratory. In February of 2004, LLNL 

provided DHS with a cost analysis to expand the laboratory capability that included 

additional instrumentation, implementation of sample tracking system, highthroughput sample processing and modified reagent contracts and formats. In 

March 2004, NYC staff was trained at LLNL in these new procedures with the goal 

to have the high-throughput laboratory in-place for the 2004 Republican National 

Convention (RNC). Based on the success of these initial programs, NYC, LLNL, 

DHS and CDC initiated 3 additional pilot programs beginning in 2004 to address 

IT enhancements, autonomous detection systems (APDS) and an improved platform 

for high-throughput testing (Luminex). The goal was to then provide other jurisdictions with these enhanced capabilities. 

PHL, LLNL, CDC and DHS maintained close working relationships from 2004– 

2009 during the development, deployment, and testing of the APDS program. In addition, BioWatch stakeholders throughout the city have been increasingly involved 

with DHS and CDC regarding the BioWatch mission, and we welcome continued involvement and collaboration. Efforts have been made in the past 6 months to improve communication and interaction between local, State, and Federal stakeholders 

who have invested much time and effort since 2003 in the BioWatch program. 

One NYC experience illustrates the importance of improved communication. In 

2003, NYC and Federal partners began planning for special biosurveillance to be 

conducted during the 2004 Republican National Convention (RNC). Routine 

BioWatch testing was to be conducted by PHL, and Federal partners were to collect 

National Security Special Event (NSSE) samples and test them at PHL. Weekly 

planning meetings with all partners were held for nearly a year to prepare for the 

event. The NYC DOHMH worked closely with local, State, and Federal law enforcement agencies to develop a series of temporary security enhancements and procedures to ensure the safety of our staff, visitors, and information during the RNC 

event. Analytes were coded per mandate to ensure security, and testing was to be 

performed under ‘‘secret’’ conditions. Less than 48 hours prior to the Convention’s 

start, our Federal partners changed the reporting protocol. PHL was notified by the 

National Laboratory Program Manager that all NSSE data was to be reported directly to the National Laboratory Director. The National Laboratory Director was 

to notify the National Laboratory Program Manager. The National Laboratory Program Manager was to then report the results to our Federal partner. Despite nearly 

a year of planning that involved all local and Federal partners, the structure and 

processes were changed at the ‘‘eleventh hour’’. While the ‘‘new’’ reporting algorithm 

was not objectionable, the lack of communication and lack of transparency was 

counter-productive to the mission. 

NYC’s long involvement in the BioWatch program has resulted in some insight 

into the program. Based on our experience, we urge Congress to clearly define the 

roles and responsibilities of the entities involved—CDC, DHS, the contracting agent 

responsible for laboratory personnel, and the host laboratories. In addition, there is 
11 

a need for a central Federal entity to guide consequence management planning in 

the event of a BioWatch Actionable Result (BAR). 

We are concerned that DHS have adequate resources to support the additional responsibilities provided in this legislation. DHS is relatively new, and currently appears to be under-resourced. For example, the BioWatch program suffers from 

underfunding. The program was deployed hastily, and without an apparent understanding of what the true program costs would be. It is not clear that the correct 

funding algorithm for this program has yet been developed. Testing personnel, instruments, and reagents are Federally funded. Local scientific and administrative 

oversight, laboratory support, security personnel and infrastructure, and overhead, 

such as space, waste disposal, equipment (e.g., autoclaves and biological safety cabinets), and office support are not Federally funded, and represent a significant burden on laboratory budgets. Resources to build a quality system for the program are 

urgently needed. I am sure this committee is well aware of the consequences of unreliable BioWatch results, and I want to thank the authors for recognizing this need 

in section 2132 of H.R. 5498, which would provide additional financial support. 

In ‘‘The World at Risk,’’ the Commission for the Prevention of WMD Proliferation 

and Terrorism also recommended new Government investments in biosafety and 

oversight of laboratories working with select agents. Comprehensive biodefense 

needs to address both intentional and accidental releases of biological threat agents. 

The NYC DOHMH is responsible for detecting and mitigating the impacts from any 

infectious disease outbreak that threatens public health, whether it is caused naturally, intentionally, or accidentally. However, the NYC DOHMH does not have access to information that would enable it to mitigate vulnerabilities in certain laboratories before an accident occurs, or to be confident that spills and other accidents 

in NYC laboratories working with select agents would be reported promptly to the 

NYC DOHMH. Academic research laboratories are not regulated by New York City 

or New York State government, and through the Select Agent Act, the Federal Government provides the only oversight of biosecurity and biosafety within these facilities. The CDC releases only contact information to local and State public health 

agencies for laboratories regulated by the Select Agent Act. It is possible, for example, that a researcher could be exposed to a select agent through a laboratory accident, become ill, and expose others outside that laboratory. A second, limited SARS 

outbreak in 2004 resulted from just such a breakdown in biosafety in a Chinese laboratory. In the proposed bill, we hope that sections 2105 and 2107 will provide for 

the sharing of information with public health departments that would be needed to 

mitigate and respond to select agent incidents in laboratories within their jurisdictions. As responsibility for Tier 1 and Select Agent Programs shifts from the Department of Health and Human Services to DHS, we encourage the Federal Government 

to take steps that address the public health requirements of jurisdictions within 

which select agent research takes place. Local and State public health agencies need 

to have access to detailed information related to the biological agents and biosafety 

programs at each laboratory regulated by the Select Agent Program. 

The proposal in section 2104 of H.R. 5498, to redefine a set of select agents as 

Tier 1 agents that require enhanced security, makes sense. However, the concordant 

enhanced biosecurity that will be required of facilities that handle these agents 

needs to be resourced appropriately and annually. Additional requirements will necessitate additional personnel. Currently, the NYC PHL Select Agents program has 

a Responsible Official (RO) and an Alternate Responsible Official (ARO); both are 

senior-level laboratorians that manage the program as one of their regular duties. 

Over time, increased duties for the RO and ARO in the form of increased responsibility for inspections and oversight, added requirements for conducting drills of increasing complexity, and requirements for detailed after-action reports have significantly increased workloads. However, there has been no concomitant increase in 

funding. Proposed additional requirements for handling select agents and Tier 1 

agents need to be accompanied by an increase in funding for affected laboratories, 

including allocations for high-level personnel to oversee the program. Enhanced biosecurity for Tier 1 agents proposed in the legislation will be costly. 

Public health laboratories are subject to regulation from a number of agencies. In 

addition to the LRN, the NYC PHL is a member of the Food Emergency Response 

Network (FERN), the environmental Laboratory Response Network (eLRN), and the 

chemical Laboratory Response Network (LRN–c). The development of the Integrated 

Consortium of Laboratory Networks (ICLN), as provided in section 2136 of the proposed bill, promises to integrate and streamline regulations. We have yet to see benefits from the ICLN. We are still required at the public health laboratory level to 

input data into multiple, distinct data management systems, and the data is analyzed by each individual Federal agency. The public health laboratory community 

has advocated for several years the use of a single laboratory data information man-
12 

agement system, but this has not yet come to fruition. We support the participation 

of public health laboratories in the ICLN and look forward to a more focused and 

determined approach to integration. Organization through the ICLN could result in 

increased efficiency of resource use. 

The NYC PHL is one player among many local, State, and Federal entities comprising the antiterrorism preparedness and response efforts in NYC. It is our duty 

to be prepared to provide the necessary surveillance, routine, and surge testing to 

support the emergency preparedness and response effort of the city. We need the 

support of our Federal, State, and local partners to be able to do this. Preparedness 

means not only meeting the threats of today, but also anticipating the threats of 

tomorrow. The building housing the NYC PHL was designed in the late 1950s and 

was opened nearly 45 years ago. An updated and upgraded facility is badly needed, 

and we are developing plans for a state-of-the-art facility that incorporates needed 

biosecurity and containment measures, as well as the technologies needed to detect 

emerging and re-emerging pathogens. However, the city faces challenges in funding 

construction of the new facility, particularly in the current economic climate. To optimally prepare for the future, the city would welcome the collaboration of the Federal Government in planning, funding, and ensuring the further development of a 

state-of-the-art public health laboratory for highly-at-risk New Yorkers and for the 

Nation. 

The New York City Department of Health and Mental Hygiene appreciates the 

opportunity to testify on the development and implementation of the important 

measures outlined within H.R. 5498, the ‘‘WMD Prevention and Preparedness Act 

of 2010.’’ While I have limited my comments today to issues related to the NYC 

PHL, the city would like the opportunity to provide more detailed comments on the 

entire bill reflecting the concerns of all of our key emergency response agencies. The 

NYC DOHMH stands ready to assist the committee, and our Nation, in any way 

possible, to develop and implement these critical initiatives. Again, thank you for 

the opportunity to testify, and I look forward to answering any questions you may 

have. 

Ms. CLARKE. We thank you, Dr. Beatrice, for your testimony. 

I now recognize Dr. Murch to summarize his statement for 5 

minutes. 

STATEMENT OF RANDALL S. MURCH, ASSOCIATE DIRECTOR, 

RESEARCH PROGRAM DEVELOPMENT, NATIONAL CAPITAL 

REGION, VIRGINIA POLYTECHNIC INSTITUTE 

Dr. MURCH. Thank you, Chairwoman Clarke and Members of the 

committee. I appreciate the opportunity to come before you today. 

You know from the Chairwoman’s comments on my background 

it is heavily involved in sciences technology intelligence operations 

involving counterterrorism and weapons of mass destruction terrorism. I will summarize my comments from that perspective. 

I strongly support the development and coordination and implementation of a National intelligence strategy. I believe it is an important roadmap for the Nation. But while creating and vetting 

such a strategy is important, as with many endeavors and Government and public policy and programs, implementation requires 

plans, measures of progress, and accountability. There are plenty 

of good ideas that never go anywhere and good strategies and plans 

that go adrift for lack of focus or interest. 

So in my view it is not important simply to state where we 

should be heading, but what we are going to do, when we are going 

to do it, who is responsible for what, and measure how well we are 

doing. It is also important for us to know how well we know how 

well we are doing. 

These should come through clearly articulated goals and objectives, assignments, and responsibility requirements, expectations, 

and measures of success. I am very gratified to see that provisions 

have been made in the legislation for planning and reporting. 
13 

It is also important to have someone clearly in charge. When everyone is in charge, no one is in charge. I hope that the DNI would 

take that role. Congress, too, has an important responsibility for 

oversight in this legislation and beyond. 

This is a very complex system that we are trying to address. For 

those who participate, priorities and assignments and responsibilities should be well matched to the department and agency authorities, responsibilities, and capacities. For example, the copy of the 

legislation that I saw noted that the director of national intelligence should develop and implement a strategy in consultation 

with the Secretary of homeland security and heads of other departments and agencies. 

It is important that DHS be involved, clearly, but in my view it 

is absolutely necessary to raise the involvement of the other nonDHS Federal departments and agencies that have more direct 

front-line responsibilities and roles in domestic security, law enforcement, and intelligence as equal partners. Those latter agencies 

do indeed have many years of experience and expertise and committed resources in areas such as WMD intelligence and response. 

Perhaps more better focused and more innovative and integrated 

initiatives are necessary to address these very substantial challenges and gaps we face with WMD intelligence, but we should acknowledge that DHS is a relative newcomer. 

I would like to move on now to the National intelligence strategy 

for countering biological threats. Many of the points I made above 

are applicable here, but I think the key point that I would like to 

make with you is to tightly couple the strategy with the broader 

National intelligence strategy, that they are closely interrelated. 

It is known in a number of quarters inside and outside the intelligence that bio-intelligence, that colloquial phrase that is often 

used, is very important. It is a fundamentally very hard problem, 

and it is going to take innovation, creativity, resources, planning, 

and commitment over many years. It is not going to happen overnight. It is probably not going to happen in a single budget year. 

We can learn lessons again by going back to an Institute of Medicine study that was published in 2006 called ‘‘Globalization Biosecurity and the Future of the Life Sciences’’ to really teach us how 

complex life sciences and its misuse can be and how we might tackle it in a more effective way. 

Unfortunately, the intelligence and law enforcement communities 

cannot focus only on that, so we need to be in the right place at 

the right time focused on the right people, the right processes, a 

very significant challenge. 

In the aforementioned IOM study, it also addressed the problem 

of—or the opportunity of engaging biological experts outside of the 

Government. I actually offered that recommendation, and I think 

it was the only one that was taken up from that study. I support 

that. I think there are tools and programs that could be built on, 

such as the biological sciences experts group that was started by 

the National Counter Proliferation Center some years ago. 

Now, we quickly move on to the bioterrorism risk assessment, 

section 2103, to make a quick point. These bioterrorism risk assessments have been on-going, and they will continue to deliver important contributions. 
14 

However, one point I wish to make is that in 2006 the Department of Homeland Security engaged the National Research Council 

for review of their methodology. As a result, the NRC committee 

actually came up with a very detailed, pointed, critical assessment 

of the bioterrorism risk assessment. 

To my knowledge, and no one I have talked to knows whether 

or not DHS has accepted or rejected those recommendations, 

whether or not has anything been done, and whether or not the 

NRC committee got it right or wrong. I think it is important to reconcile that before going forward. 

Moving on to the issue of attribution, one that is near and dear 

to my professional existence over the last 15 years since I created 

the National program, I think it is important that we focus properly on a National microbial forensics strategy which is bigger and 

broader than the R&D strategy that was just published, which is 

a very important contribution, but it is not enough. We need to go 

beyond and incorporate some of the other aspects of forensic 

science that need to be incorporated and a robust approach to a 

National microbial forensics repository. 

Ms. CLARKE. Dr. Murch, can you just sort of summarize? We will 

probably get into some more of your findings through questions. 

Dr. MURCH. Yes, ma’am. 

So the National microbial forensics repository needs its own substrategy to effectively move forward. 

A couple of quick points—law enforcement training for investigating biological threats. I would strongly recommend the Department of Homeland Security, if they are going to undertake this, be 

assigned this role, that they engage the FBI and the public health 

community, as they have been working on this for 15 years, and 

we don’t want to compete or conflict with what is already on-going 

in the field and the broader community. 

Then two other quick points here on response. Integrated plume 

modeling is mentioned in your legislation. I would encourage the 

Department of Homeland Security, if they go forward, that they 

work with the Department of Defense and Department of Energy, 

who has been working on these models for many years and spent 

many millions of dollars of taxpayers’ funds, rather than duplicate. 

Then last, I strongly encourage, having been involved in two National Academy studies involving forensic science, one of which was 

involved in nuclear forensics, that the academies be engaged by the 

Department to take on a broader study—not simply the role of forensic science in homeland security, but also outlining forensic 

science in DHS with where the rest of the enterprise is going. 

Thank you. 

[The statement of Dr. Murch follows:] 

PREPARED STATEMENT OF RANDALL S. MURCH

JUNE 15, 2010 

Chairwoman Clarke, Members of the subcommittee and committee staff, thank 

you for the invitation to present a statement before you today and have my comments entered into the record regarding this important and timely legislation before 

the Congress. 

My name is Randall Murch. I am a faculty member at the Virginia Polytechnic 

Institute and State University, which is more commonly known as Virginia Tech. 

Prior to joining Virginia Tech, I had a 23-year career as a Special Agent with the 
15 

Federal Bureau of Investigation during which I was heavily involved in counterterrorism and weapons of mass destruction terrorism and counterterrorism from the 

operational, investigative, intelligence, planning, science and technology, and forensic perspectives. In my FBI career, I spent 10 years in the FBI Laboratory and over 

8 years in the technical surveillance program and oversaw forensic investigative and 

technical investigative support efforts for a number of well-known domestic and 

international terrorist attacks. During this period, the Nation endured the attacks 

in Oklahoma City, Khobar Towers in Saudi Arabia, the U.S.S. Cole, the U.S. Embassies in East Africa and 9/11, among other events. I created our National WMD 

forensic program in the FBI Laboratory in 1996 and oversaw its early development 

in partnership with other U.S. Government agencies. In my career, I served not only 

in the FBI, but was also detailed from that agency to the Defense Threat Reduction 

Agency during the latter part of my career. Later, I was loaned to the Department 

of Homeland Security, Science and Technology Directorate from Virginia Tech for 

1 year. Since 2000, I have participated in several National Academies and Department of Defense studies related to weapons of mass destruction or homeland security. I still work in relevant areas and provide pro bono advice to the Government 

in these areas, in addition to others. 

Today, I will provide comments for your consideration to some specific sections of 

the proposed legislation. 

TITLE 1: INTELLIGENCE MATTERS

Section 101. National Intelligence Strategy for Countering the Threat from 

WMD 

I strongly support the development, coordination, and implementation of a National Intelligence Strategy for Countering the Threat from Weapons of Mass Destruction as recommended by the WMD Commission to be led by the Director of National Intelligence (DNI). While the creation and vetting of such a strategy is important to lay out a high-level roadmap, as with many other endeavors in Government, 

public policy, and programs, successful implementation through plans with measures of progress and accountability are crucial. There are plenty of good ideas that 

never go anywhere, or good strategies and plans that go adrift because focus or interest is lost. 

In my view, it is not just important to state ‘‘where we should be heading’’ but 

also to state ‘‘what we are going to do’’ and ‘‘when are we going to do it’’ and ‘‘who 

is responsible for what’’, and ‘‘measure how well are we doing’’ and knowing ‘‘how 

well we know how we are doing’’. These should come through clearly articulated 

goals and objectives, assignments of responsibility, requirements or expectations, 

and measures of success. I am gratified to see that provisions have been made in 

the legislation for plans and reporting. Also someone has to be actively ‘‘in charge’’; 

when every one is in charge, no one is in charge. My hope is that the DNI will fill 

that role and do so well. The enterprise should be held accountable, otherwise having a strategy and a plan is not particularly useful or meaningful. Course corrections can be made as needed. Congress certainly has a role here through its oversight responsibilities. 

No one entity can put a strategy and such as this and the associated ‘‘complex 

system’’ into play. For those who participate, the priorities, assignments, and responsibilities should be well matched to what department and agency authorities, 

responsibilities, and capacities are or should be. For example, the copy of the proposed legislation I have notes that the Director of National Intelligence should develop and implement the strategy ‘‘in consultation with the Secretary of Homeland 

Security and the heads of other appropriate Departments and agencies’’. The Department of Homeland Security does have important coordination and consumer 

roles in the envisioned process and outcomes, some DHS agencies are ‘‘operational 

contributors and users’’. 

However, in my view it is absolutely necessary to improving our capabilities and 

performance that those non-DHS Federal departments and agencies that have more 

direct front-line roles in domestic security, law enforcement, and intelligence must 

be fully and aggressively leveraged and involved as equal partners. Those latter 

agencies I am alluding to have many years of expertise, experience and committed 

resources, in some cases substantial in each category, devoted to WMD intelligence 

and response. Perhaps more, better, better focused, and more innovative and integrated initiatives and approaches are required to address the very substantial challenges and gaps we face with WMD intelligence, but we should acknowledge that 

DHS is a relative newcomer. 

Also, during the planning process and before new initiatives and improvements 

are embraced, it may also be quite cost-effective and operationally beneficial for the 
16 

DNI to commission a comprehensive and rigorous ‘‘systems analysis’’ which would 

identify the specific and relevant capabilities that already exist and assess their effectiveness, and provide the prioritization for gaps, needs, and opportunities across 

the enterprise. This would be the informed and testable basis for designing and 

commissioning all initiatives going forward across the intelligence community. 

Section 102. National Intelligence Strategy for Countering Biological Threats 

Many of the points I noted above for the National WMD Intelligence Strategy 

could also be considered, if not embraced, for the next generation of the National 

Intelligence Strategy for Countering Biological Threats. The latter could, and even 

should, be clearly viewed and undertaken as being tightly connected to the former. 

They are not separate, competing, or mutually exclusive, but should be developed 

and implemented as being closely related, with many interrelationships and interdependencies. 

Without spending more time on this strategy itself, permit me to briefly turn to 

two issues, one which is often stated as ‘‘the need for better ‘bio-intelligence’ ’’ and 

the second which is stated in the proposed legislation as ‘‘expand efforts to create 

a national cadre of biological experts’’. 

First, it has been well known for a number of years and in many quarters inside 

and outside the intelligence community that effective and timely intelligence on adversaries’ or proliferators’ intentions, capabilities, plans, and actions are crucial in 

order to prevent, anticipate, disrupt, interdict illicit events and activities or, if an 

event or transaction of interest occurs, to respond, attribute, or prevent subsequent 

activities of concern. This is not a new revelation. Those who call most vocally for 

more and better ‘‘bio-intelligence’’ are often fundamentally are unaware of how significantly different and challenging obtaining and leveraging the most precious, 

timely, and sought-after nuggets of ‘‘bio-intelligence’’ really is. This truly is a ‘‘hard 

problem’’. If we agree that ‘‘bio-intelligence’’ is a high priority and essentially an 

unaddressed gap, then we should begin by defining and ‘‘unpacking’’ it so that all 

concerned know what it is and what ‘‘it’’ entails. From my personal experience, the 

term ‘‘bio-intelligence’’ was first coined by Dr. George Whitesides of Harvard University approximately 10 years ago. Then, he knew what he meant and those of us 

working with him on studies for the Department of Defense knew what he meant. 

Today, I’m not sure there is a single, accepted definition of what ‘‘bio-intelligence’’ 

is. What it means depends on who one is talking to. If a universal definition and 

description of the component elements can be agreed to, i.e. ‘‘terms of reference’’, 

it may be a boon to harmonizing interagency and stakeholder communication, collaboration, and action on recognized priorities. The next edition of this Strategy 

could assist with this. 

In 2006, the Institute of Medicine of the National Academies published an important study entitled Globalization, Biosecurity and the Future of the Life Sciences, 

that still helps us to frame the complexity and uncertainty of what we face with 

the future of life science knowledge and technology and their misuse. The reality 

is that we contend with is a complex, dynamic global ecosystem of rapidly advancing, diversifying, scalable, and accessible life science knowledge and applications. 

The vast majority of this endeavor is used for noble and beneficial purposes, and 

cannot be controlled. However, in this ecosystem are some who are embedded or 

hidden in, peripheral to, and protected who acquire, develop, test, and seek to use 

or profit from biotechnology and expertise for illicit and nefarious purposes. Intentional and actual misuse can occur by many ways and means, by many actors, from 

and in many places. The effects and impacts are scalable; one does not have to kill 

millions to cause significant impact. A little bioagent effectively deployed can make 

a big mess, as we experienced with the anthrax attacks in 2001. 

Intelligence and law enforcement cannot be everywhere, know everything all of 

the time, and be solely focused on ‘‘bio-intelligence’’, either domestically or globally. 

Thus, either we accept the realities we face and limitations of the capabilities and 

resources we have, or we design, fund, and institute a sustained program that identifies the most important priorities to focus on, being at the right places, at the right 

times, focused on just the right people and process nodes, all of which takes advantage of the best available expertise here and with our allies. Advancing and applying new knowledge and understanding, policies and practices, technology, and 

leveraging innovation, creativity, and calculated risk-taking must be the foundation 

upon which this effort is built. This would apply to gathering and making sense of 

large amounts of open source technical information, new infectious disease surveillance approaches, better connecting public health with intelligence and law enforcement, as well as new methods and techniques in human intelligence. There is no 

‘‘silver bullet’’ for better ‘‘bio-intelligence’’ and I’m not convinced that simply throwing money at the problem will get us any further down the road. If we agree that 
17 

a new or improved approach is necessary, we should be prepared to properly choose 

and resource our priorities and stay focused and committed. Success will not likely 

be achieved overnight or even in a single budget year. 

With regard to better engagement of biological experts for intelligence, this, too, 

is not a new idea. In my estimation, this is a particularly useful goal which should 

provide useful outcomes. In the aforementioned IOM study, such a recommendation 

was made, which I authored. As far as I am aware, it was the only recommendation 

from that study that was acted on. Soon after the study was published, the National 

Counterproliferation Center (NCPC) created the Biological Sciences Experts Group, 

which reportedly has run well and meaningfully under strong leadership at NCPC 

since then. However, the pool of highly qualified and available experts is not limitless; it is difficult to hire and retain these experts as Federal employees. Some agencies, such as the Department of Defense, have long and effectively used external experts to study and report on ‘‘very hard’’ science and technology-based problems, including those related to biological weapons and biotechnology. Other key agencies, 

such as the FBI, are still primarily focused on outside experts for scientific research 

and development or episodic support to investigations or for liaison purposes, rather 

than to support their respective mission and responsibilities in intelligence. Perhaps 

working with the Congress, the DNI, and outside senior experts, those agencies that 

do not have sufficient access to outside experts can improve access to support their 

intelligence-related missions and help address ‘‘grand challenges’’, gaps, needs, and 

opportunities. This could occur through a single cadre available to the entire intelligence community, perhaps by expanding the BSEG and tailoring as needed, or creating similar groups for each agency that are modified. However, with agencies creating their own versions they could well run up against a shortage of knowledgeable, experienced experts. In reality there are only so many highly qualified experts 

to go around. 

I now wish to address to five other sections in the proposed legislation. 

TITLE II. HOMELAND SECURITY MATTERS

Subtitle A—Prevention and Deterrence 

Section 2103. Bioterrorism Risk Assessment 

This subsection ‘‘requires that the Secretary of Homeland Security, in coordination with the heads of other appropriate Federal departments and agencies, to 

produce biennial integrated Bioterrorism Risk Assessments to identify and assess 

evolving biological risks to the nation’’. It is well recognized in the community of 

interest that this activity makes critical contributions to risk management and risk 

reduction by supporting strategies, plans and programs, investment decisions, and 

public policy. When properly designed, conducted, and used, these assessments will 

continue to prove to be important to the future of our National counter-bioterrorism 

and biodefense enterprise. However, just as it is important to perform and provide 

these assessments, it is also important to conduct them in a rigorous, accurate, reliable, scientifically-sound, and defensible manner. The users of and stakeholders for 

these assessments should be able to rely on these assessments with confidence. 

In 2006, at the request of the Department of Homeland Security, the National Research Council established a committee to provide a review of DHS’ Bioterrorism 

Risk Assessment (BTRA) methodology. This study resulted in an interim report focused on near-term improvements and a final report which included recommendations for longer-term improvements. The latter was published in the open literature 

in 2008. The final report, which includes the interim report in an appendix, provided a detailed, pointed, critical assessment of DHS’ Bioterrorism Risk Assessment 

methodology and provided a number of recommendations for improvement. To my 

knowledge and through queries in the community of interest including those in the 

Government, DHS has not substantively or publicly responded to this report. We do 

not know whether DHS agrees or disagrees with or has acted on any or all of the 

NRC’s observations and recommendations. If they disagreed, we should know why 

this is justified. If they have addressed some or all of the NRC’s concerns, this 

would provide us with greater confidence that the BTRA is on the right track. Concomitantly, we do not know whether there is a basis for concern that the NRC got 

it wrong all or in part. If that is the case, there should be pause with future studies 

coming out of the NRC, since the National Academies reputation is built on performance that is expected to embrace independence, objectivity, relevance, and quality. 

Going forward, a point-by-point response by DHS to this particular NRC report 

is not an unrealistic or outlandish expectation. All that is being asked for is to come 

full circle on the BTRA peer-review process. Good science often leads to sound public 

policy, programs, and benefits and gives all concerned greater confidence. Some-
18 

times peer review can be harsh; I know this first hand as one who helped lead the 

FBI Laboratory through a very difficult time in the mid-to-late 1990s in an intense 

period of scrutiny from many quarters resulting from allegations that the quality 

of its science and performers were sub-optimal. Further, sometimes peer reviewers 

are peer reviewed themselves with surprising results. But the process is universally 

accepted and is designed to make the science and its performers better. This situation should be treated no differently, especially because of its importance. 

Given the importance of the BTRA and the observations, recommendations, and 

conclusions reported by our Nation’s leading body of scientific, medical, and engineering experts, this should be resolved and done in a manner that gives all concerned confidence that future BTRAs will always be performed using the best possible methodology and provide the most useful and reliable assessments. This action 

should also inform the interagency task force that is called for in the legislation. 

Subtitle D—Attribution 

Section 2141. Bioforensics Capability and Strategy 

Bioforensics is a discipline and National capability that has been near and dear 

to my heart and professional existence for the past 15 years. I initiated the latter 

from the FBI Laboratory in prior to the 1996 Olympic Games which gave birth to 

the former, and oversaw their early development and have been heavily involved 

various aspects ever since. I still do believe strongly that an effective, reliable, testable, defensible, credible forensic capability for biological agents, toxins, and associated traditional physical evidence is an important ‘‘tool’’ in our Nation’s biosecurity 

‘‘kit’’ specifically to support attribution decisions, legal prosecutions, policy decisions, 

and possibly significant follow-on actions. Though DHS is prominently mentioned in 

this legislation and previous policy documents and legislation, they are one of a family of agencies that have stakes in an encompassing and robust capability with the 

attributes I mentioned above. 

We have made significant progress in a number of areas within microbial 

forensics over the past 15 years, but much remains to be done to bring our capability to full fruit so that can address likely events, predictable contingencies, and 

perhaps some exigencies with some surety. While good science exists to draw upon 

and many lessons have been learned from prior events, there are many gaps in the 

science and practice, unaddressed forensic requirements, infrastructure needs, and 

National assets that have yet to be established. One important contribution to moving forward was the recently-published National Microbial Forensics R&D Strategy 

led by The Office of Science and Technology Policy which is useful to harmonize the 

community and encourage collaboration and reduce duplication. 

A broader, more overarching strategy document is needed which encompasses not 

only scientific advancements but also addresses common practices, standards, and 

shared infrastructure resources such as a National Microbial Forensics Repository, 

which is also mentioned in this section. Future legislative and policy documents not 

only need to mention what needs to be done, but also enable ‘‘the how’’ and ‘‘who’’ 

and what should the outcomes sought should be. These documents should do so to 

address and balance all appropriate needs and equities of key agencies, now and 

into the future. 

Having a properly constructed, populated, operated, and maintained repository of 

known samples against which evidentiary samples can be compared is essential to 

the proper performance of forensic analyses and rendering conclusions, to include 

those that support attribution decisions. A repository of this nature can also provide 

important resources for research, method development, and testing. DHS is an important player and has been assigned a leading role in establishing the Repository, 

as alluded to in the legislation. However, it cannot and should not do this in a vacuum or without the cooperation, collaboration, participation, and shared value and 

risk of other Federal partners and other constituencies. For agencies to simply give 

samples to the National Bioforensics Analysis Center does not make a properly designed, functioning, and responsive National Microbial Forensics Repository, de 

facto. The call for a National Repository has been percolating in the microbial forensic (bioforensic) community for several years. There are differing views of experts 

as to how it should be designed and structured, what it should contain, how it 

should be organized and function, what standards should govern the science, and 

how best it can meet the needs, equities, and expectations of all prospective users 

and stakeholders. 

As this effort would be very complex with many issues yet to be defined, I have 

recommended to my colleagues in this community that a well-constructed and conducted systems analysis could provide the proper foundation the desired capability. 

This would define the ‘‘what, why, where, when, who, and how’’ for future planning 

and execution. 
19 

Section 2142. Law Enforcement Training to Investigate Biological Threats 

I must admit reading this section gave me some concerns, largely because DHS 

which is fundamentally not the lead involved in the law enforcement or public 

health investigations of biological threats is now being given a role in training those 

communities. At the Federal level, for nearly 15 years the responsibility for lead 

agency rests with the FBI and the Centers for Disease Control and Prevention 

which have been working closely together since 1996 to establish and improve investigative response and resolution. These two agencies, their parent departments and 

the communities they work with closely at the State and local levels have been 

doing this collaboratively for many years. Protocols, practices, and methods have 

been developed and are continually being refined. Many years of practical case experience resides with these agencies and the communities they work with. 

More training may be needed but it should not be designed, planned, or provided 

so as to compete or conflict with what is being provided or the investigative processes and protocols that have been developed and used by the FBI and their field 

WMD Coordinators, the FBI Laboratory’s Hazardous Materials Response Unit, FBI 

field office Hazardous Materials Response Teams, the FBI-led Joint Terrorism Task 

Forces, the CDC, State, and local public health and emergency services agencies, the 

Laboratory Response Network and others. To do otherwise could potentially threaten the health and safety of responders and integrity and success of bioterrorism investigations and prosecutions. 

If DHS does provide this training now, or will be expected to, they should meet 

the requirements and expectations of the principal law enforcement and public 

health agencies that have the lead and who work most closely those who support 

these investigations. Close coordination with other appropriate agencies should be 

required; those agencies should monitor or participate in what DHS provides. Perhaps National standards should be developed, validated, and adhered to by all training providers to ensure the highest uniformity and quality. 

Subtitle E—Response 

Section 2152. Integrated Plume Modeling for Collective Response 

This legislation calls for the Secretary (of Homeland Security) to ‘‘acquire, use and 

disseminate timely integrated plume models to enable rapid response activities following a chemical, biological, nuclear or radiological event.’’ 

Two key points with regard to this section: The Departments of Defense, including 

the Defense Threat Reduction Agency as well as others in DOD, and the Department of Energy in several of their National Laboratories, have spent many millions 

of taxpayers’ dollars, have developed substantial expertise, and have produced usable plume models as a result of many years of effort. It is recommended that the 

Department of Homeland Security begin its search for, and assessment and acquisition of models in these Departments with leading experts. It is highly likely that 

it will be a massive and unwarranted waste of Federal funds for DHS to initiate 

its own de novo plume model research and development program. 

With regard to the dissemination of plume models, I ask the questions ‘‘who are 

these models to be disseminated to?’’ and ‘‘if the recipients have no going-in capacity 

to effectively work with these technologies, who will provide training, seamless 

handoff, and reachback after the modeling technology has been provided?’’ In my 

opinion, even if well-intentioned, simply ‘‘throwing technology over the transom’’ will 

not be beneficial to those it is intended to help. If DHS will be in position to acquire, 

use and share DOD- and DOE-developed plume models, or from other sources that 

are recognized as ‘‘gold standard’’, then it should ensure that it has the requisite 

expertise to use them and provide effective training and reachback to those it provides the models to and expects to use them for improved planning, exercises, response, and recovery. I worry that this technology will be provided to the first responder community and just sit on the shelf and not be used or not be used effectively. 

Section 208. National Academy of Sciences Study of Forensic Sciences in 

Homeland Security 

I strongly support your legislative initiative for DHS to engage the National Academy of Sciences for a study on the role of forensic sciences in homeland security. 

This door was opened in the NAS study published in 2009 which was entitled 

Strengthening Forensic Science in the United States: A Path Forward. I was a member of the committee that produced this report and contributed to the section on forensic science and homeland security. This landmark study has been met with great 

interest and angst, and is beginning to change how forensic science will be funded, 

trained, performed, managed, scrutinized, and used in the courts, and is viewed by 

the media and public for years to come. This is very useful reading for how forensic 
20 

science should be advanced and improved. I am aware that the Senate Judiciary 

Committee is in the process of introducing legislations that acts on most of the recommendations of this report. 

A forthcoming NAS study on the Nation’s nuclear forensics capabilities, for which 

DHS’ Domestic Nuclear Detection Office was one of three sponsors, will also provide 

valuable insights in this particular specialty of forensic science. I was a member of 

the committee that produced this report, as well. The NAS is also currently conducting a study for the FBI to assess the science that was developed and applied 

to the bioforensic evidence collected and analyzed to support the anthrax investigations which began in October 2001. DHS supported those investigations by scientific 

support from the National Bioforensic Analysis Centers and through others. Thus, 

the stage is certainly set to go forward with a new study by the NAS which focuses 

on forensic science and homeland security more broadly. Requiring a study by the 

NAS of forensic science for homeland security is a substantially good intention. 

But, because of the legitimate concerns with forensic science and its use in our 

legal system, and the uncharted waters of forensic science being used to support policy decisions, I strongly recommend that the NAS study not only address the role 

of forensic science in homeland security but also be focused on the current state of 

forensic science in DHS as it is developed, validated, used and practiced, planned, 

managed, and intended in all of the agencies and components that have forensic 

science programs and capabilities of any sort or type. This aspect of the study 

should be comprehensive from traditional forensic science disciplines such as pattern evidence, DNA and chemistry and specialties such as bioforensics (microbial 

forensics), and nuclear forensics. Without this additional aspect, any NAS study on 

forensic science for homeland security would be incomplete, and be an opportunity 

missed. The Nation should demand that its forensic science enterprise will meet or 

exceed requirements and expectations and embrace best science and practice wherever it resides or for whatever mission it supports, including within DHS. 

This concludes my testimony. I’ll be pleased to try to answer your questions or 

address your comments. Thank you. 

Ms. CLARKE. Thank you very much, Dr. Murch. Thank you for 

your testimony here today. 

I now recognize Dr. Kadlec to summarize his statement for 5 

minutes. 

STATEMENT OF ROBERT P. KADLEC, VICE PRESIDENT, 

GLOBAL PUBLIC SECTOR, PRTM MANAGEMENT CONSULTING 

Dr. KADLEC. Thank you, Madam Chairwoman, Ranking Member 

Mr. Lungren and Mr. Pascrell. It is a great honor and privilege to 

be here today. I have dedicated most of my professional life in and 

out of uniform to address this issue of biological warfare and bioterrorism because of my deep conviction that the successful use of 

biological weapons can radically and forever change our Nation and 

our way of life. 

I would like to applaud you and your colleagues for holding this 

hearing and congratulate you in particular, Representatives Pascrell and King and their staffs, Dr. George, for their newly drafted 

bill, H.R. 5498. I think it is a welcome addition to the other important pieces of legislation Congress has introduced and passed to address this serious problem. 

During my tenure as special assistant to the President, I was 

able to basically provide him an analysis that indicated that if 

there were to be a successful attack with anthrax in a major metropolitan city, that that could result in several hundred thousand 

casualties and cost the Government $1.5 trillion in immediate direct costs. 

It is clearly an issue that in these economic hard times that some 

people say we can’t afford to do this to be fully prepared, but I suggest to you that we can’t afford not to do it. With that, I would like 
21 

to just spend a couple of moments to highlight some of the great 

provisions that you have in your bill. 

Clearly, your bill is comprehensive. Clearly, it is one that is 

going to take further study by a variety of experts and provide 

input to your staff. But I believe it is an important contribution to 

the overall dialogue and again I think results in the right form and 

tone in the sense of urgency that must be taken to address this 

issue. 

First of all, subject to the issues of biosecurity and laboratory security, I welcome the notion that the select agent list is probably 

too long and too arduous and doesn’t reflect the issues and agents 

that represent the greatest risk and potential impact to our country. 

But I think it is worthwhile that the negotiated rulemaking that 

is identified in this bill includes the Department of Homeland Security as well as the secretaries of HHS and USDA to basically address that, as well as stakeholders from academia and the private 

and public communities, to make sure that they understand what 

they have to abide to as well as provide input into this and get the 

right balance. 

I also want to strongly endorse the creation of the high containment biological security grants. I think you heard from the previous witness the costs that are associated with enhanced security. 

Sometimes this cost comes at the expense of conducting either vital 

scientific work or day-to-day activities in these research and public 

health institutions. Providing grants to offset the current and likely 

increases in security is essential to the success of this entire effort. 

I also want to reiterate the importance of the work that you are 

doing in the area of protection and biological identification, particularly increasing the ability to understand and increase situational 

awareness. Obviously, the National Biosurveillance Integration 

Center is a matter of contention, and I welcome questions on that. 

I also want to underscore the role that you have for the EPA and 

OSHA in the area of recovery and restoration. The costs that we 

could not necessarily calculate as a result of this analysis that was 

conducted by the Council of Economic Advisors to the President 

was the notion of how long it would take and how much it would 

cost to restore a metropolitan area once again so that normal livelihood and business could be conducted. 

Another area that I think is closely linked to this recovery and 

restoration from a biological attack is an issue that you have identified under Title 3 of the public health matters, and that is a National Pre-Event Vaccination and Antimicrobial Distribution Policy 

Review. It is probably the most, I would say, urgent issue that 

needs to be addressed within your bill, primarily because the best 

way to ensure that our responders will do their jobs effectively and 

safely is for them and their families to be afforded the highest level 

of protection possible. 

In light of that approach, pre-event vaccination and distribution 

of antibiotics not only makes sense, but is essential. I am deeply 

disturbed about our current approach—we have vaccines, such as 

an FDA-approved vaccine for anthrax, that is expiring on the 

shelves of the strategic National stockpile. Expired vaccines are 
22 

useless to everyone, but a vaccinated first responder is priceless to 

everyone. 

I also hope that you will have the opportunity to ensure that 

families of first responders have the opportunity to have an FDAapproved med kit that can be pre-positioned at homes or places of 

work to ensure that their first responders’ families can go about 

their business without worrying about their families. It is interesting to note that in many airports as part of the U.S. postal program, delivery program, that volunteer postal workers have in 

their possession antibiotics for themselves and their families in 

case of biological attack. 

In closing, I want to again congratulate and endorse the work of 

this committee and the responsible members of its staff. This bill 

will go a long way to advance the status of preparedness of this 

country for a threat that is unthinkable, but likely. I very much appreciate the opportunity to appear before you and look forward to 

your questions. Thank you. 

[The statement of Dr. Kadlec follows:] 

PREPARED STATEMENT OF ROBERT P. KADLEC

JUNE 15, 2010 

INTRODUCTION

Madam Chairwoman it is both a privilege and honor to appear before you and 

your colleagues to discuss this issue of great importance to America’s National security. I have dedicated most of my professional life to address the issue of biological 

warfare and bioterrorism because of my deep conviction that the successful use of 

biological weapons can radically and forever change our Nation and our way of life. 

I note that Senators Graham and Talent made the risk from biological weapons 

their central theme of their 2008 report ‘‘World at Risk’’ and their 2010 report card. 

I too share their concern about the risk of complacency and false assumptions that 

currently affect our preparations for the consequences of this threat. 

I would like to applaud you and your colleagues for holding this hearing and congratulate you and in particular Representatives Pascrell and King and their staffs 

for their newly drafted bill: H.R. 5498. As I will highlight in a few moments it represents a welcome addition to the other important pieces of legislation Congress has 

introduced and passed to address this serious problem. 

HISTORICAL CONTEXT TO THE THREAT

I would like to start by briefly underscoring the central tenets that shape my 

words and indeed shaped my actions over the last two decades. Biological warfare 

and bioterrorism have largely remained a current hypothetical threat. We were fortunate in 2001 that the likely perpetrator of the anthrax letter attacks only intended to scare and not kill scores of Americans. We likely won’t be that lucky next 

time. There are some who wrongly equate those attacks with the kind of threat we 

may confront in the future. This kind of wishful thinking is not only wrong but dangerous. Further, the notion that is now a frequent comment made by some equating 

natural threats like pandemics and emerging diseases to bioterrorism, noting that 

Mother Nature is a pretty good terrorist, is similarly wrong and also dangerous. Assuming that bioterrorism is equal or some kind of lesser included case of natural 

events like pandemics is irresponsible and demonstrates the lack of understanding 

of the nature of the threat. 

Mother Nature is not a thinking enemy as Clausewitz noted in his seminal work 

on military strategy. Mother Nature is not trying to create pathogens in a 3–5 micron particle size aerosol that is optimum to infect and deliberately kill men, 

women, and children in a given city or geographic area for a political cause. Mother 

Nature does not deliberately create pathogens that circumvent our defenses such as 

antibiotics. She does so incidentally not because she chooses to but because we 

choose to use antibiotics in a way that makes it more likely. Mother Nature does 

not care about political boundaries. Terrorists and adversaries of the United States 
23 

would use biological weapons as part of a deliberate plan to exploit our 

vulnerabilities and attack innocents to destroy our country and way of life. 

I don’t make these comments based on personal opinion but on the basis of knowing the facts of what the United States demonstrated in the 1950’s and 1960’s. During the course of the U.S. offensive program that ended in 1969, actual field tests 

such as Red Cloud Shady Grove and many others using live agents demonstrated 

the equivalent lethality of biological weapons to our most potent nuclear weapons— 

hydrogen bombs. 

President Nixon and his advisors understood that biological weapons were strategic weapons that worked too well. Their greatest value was not on the battlefield 

but in cities as weapons of terror that could kill civilian populations potentially directly or starving them by attacking animal and agricultural targets. Counting on 

the America’s nuclear superiority in a bipolar world, Nixon chose to renounce these 

weapons unilaterally and supported a global ban prohibiting the development and 

use of the entire class of weapons. The historical context to this decision was the 

United States and the rest of the world stood at the cusp of the biotechnology revolution. 

America’s moral high road leadership did much to galvanize responsible nations 

to choose against biological weapons. We now know that the Soviet Union used the 

veil of biological arms control to pursue the most extensive and advanced biological 

weapons program known to man. They succeeded in ways that boggle the mind and 

tear at the heart: Weaponizing highly virulent strains of small pox at the time when 

the world was seeking to eradicate that scourge; creating strains of anthrax and 

plague that were resistant to multiple types of antibiotics; and seeking to create 

new pathogenic agents whose effects would confound medical diagnostics and have 

now treatments. The whereabouts of these weapons and more importantly the information and the people who made them is still in doubt. The recently published Pulitzer Prize-winning book ‘‘The Dead Hand’’ by David Hoffman offers glimpses into 

the Soviet’s biological plans and programs and is an authoritative account of their 

deception and duplicity. 

This is a history that many have forgotten. More recently during my tenure as 

Special Assistant to the President and Senior Director for Biodefense Policy for 

President Bush, analyses we sponsored revisited some of these lessons forgotten and 

provided a current context to the risk. A single attack by a terrorist organization 

or a group of disaffected individuals could threaten the lives of several hundred 

thousand and have a direct cost over $1.5 trillion. When critics argue we can’t afford 

in today’s economic hard times to prepare fully, I suggest that we cannot afford not 

to. I urge you Madam Chairwoman and your colleagues to revisit the lessons 

learned and regrettably forgotten from our former program to fully understand the 

great challenge that we are confronted with. 

COMMENTS ON H.R. 5498

The bill that is the subject of today’s hearing is a welcome and helpful significant 

step forward. It is comprehensive and highlights a number of areas where more 

progress is needed urgently. 

I would like to comment on certain aspects of the bill that deserve special mention. 

Title II: Homeland Security Matters 

Subtitle A: Prevention and Deterrence: Enhanced Biosecurity Measures 

First, the bill addresses the need to update and streamline the measures used to 

ensure that work with dangerous pathogens is both safe and secure. I know firsthand the challenges that exist trying to find the right kind of balance to permit important, no vital work with high-risk pathogens to ensure with have the necessary 

antibiotics, vaccines, and antidotes while ensure the risk of malicious diversion. I 

note that your language requires the Secretaries of Health and Human Services and 

Agriculture to work with the Secretary of Homeland Security using negotiated rulemaking. 

The premise of this provision I think is the right one which is that the list of 

agents of concern should be for the biological or toxin agents of greatest risk. The 

current list of Select Agents is too long and not reflective of the agents that represent the greatest risk and potential impact. I think it is also essential and noted 

in your bill language that representatives from the academic, private, and public 

communities should have a seat at the table to ensure that the standards and practices set have been discussed and agreed to by the entities that will have to abide 

and implement such rules. In the end, I anticipate that the right balance of responsibility for safety and security and reasonableness will prevail. 
24 

I also note and strongly endorse that creation of High Containment Biological Security Grants. Up to this point, the costs of enhanced security have come at the expense of conducting the vital scientific work at these research institutions. Providing 

grants to offset the current and likely increases in security required is essential to 

the success of the entire effort. 

Finally, I note that your Senate colleagues, Senators Lieberman and Collins have 

written similar provisions in their Bill Senate 1649. While there are differences between these two pieces of legislation, the opportunity to create a realistic and less 

onerous mechanism to oversee high-risk pathogens is a great one. 

Subtitle B: Preparedness: Detection of Biological Attack 

There is an important provision contained in your bill that I wholeheartedly endorse and wish to expound on. 

The provision devoted to ‘‘Detection of Biological Attacks’’ is vitally important to 

fully implement. Unless we have more rapid environmental detection of biological 

attacks, we will not likely be able to mount an effective response to a large-scale 

bioterrorism attack. BioWatch as originally created was viewed as the best we could 

do 7 years ago. The system has performed admirably to date and has had the added 

benefit of compelling the public health and emergency response communities to address the opportunity that environmental detection offers by verifying the release 

of a biological agent before anyone becomes clinically ill. 

As good as the system is now; it is too slow to mount the kind of response that 

will be necessary should an attack happen. Accelerating the development and deployment of automated biological detection in conjunction with advanced point of 

care diagnostics for the agents of greatest concern should be one of the highest priorities. I note with great confidence the role of the Under Secretary of DHS in both 

environmental detection and rapid biological threat detection and identification and 

her ability to successfully achieve these tasks. 

Subtitle F: Recovery: Recovery and Restoration From a Biological Attack or Incident Guidelines 

I strongly endorse the provision contained in this section of the bill. One of the 

major unknowns that we confront from the risks of a biological attack is the residual threat. While there are anecdotal experiences that indicate that there may be 

significant residual hazards from indoor and outdoor releases. 

There is a great need to better understand and validate these potential risks. Furthermore, there is a need to promote the development of capabilities to address the 

possible consequences. I applaud your language that enlists the involvement of EPA 

and OSHA to reconcile before an event the standards that constitute safe and effective for the response community and general public. 

Title III: Public Health Matters National Pre-event Vaccination and Antimicrobial 

Distribution Policy Review 

A prepared response workforce is our best hedge against uncertainty. One of the 

best ways to ensure that our responders will do their jobs effectively and safely is 

for them and their families to be afforded the highest level of protection. In light 

of that approach pre-event vaccination and distribution of antibiotics not only makes 

sense but is essential. 

What is deeply disturbing about our current approach we have vaccines such as 

FDA-Approved anthrax vaccine that is expiring on shelves in the Strategic National 

Stockpile when it could be offered voluntarily to first responders in areas where the 

risk of a biological attack is evaluated higher than others. Expired vaccines are useless to everyone, but a vaccinated first responder is priceless to everyone. 

Furthermore, looking at the opportunity to ensure that the families of first responders are take care of opens the possibility of developing FDA-approved 

MEDKITS that can be pre-positioned at homes or places of work that ensure that 

first responders are not worried about taking care of their families. This has been 

shown to be invaluable in the case of postal workers in Minneapolis who have volunteered to be part of the U.S. Postal program. Antibiotics are prescribed for both 

the volunteer postal worker and his or her family. In case of a biological attack, the 

responder can go do his or her duty without worrying about their families. 

There is one last subject I would like to mention subject to your bill and that is 

to emphasize the importance of situational awareness as it relates to the evolution 

of a biological attack. As we experienced most recently with the H1N1 pandemic and 

even during the on-going crisis in the Gulf with oil spill, situational awareness— 

knowing what is going on with a high degree of confidence—is essential. There have 

been several attempts to address this critical enabling element in our biodefense 

strategy. Again and again we have come up short. I note that your bill highlights 

that important function and I endorse the goal and the importance of it. 
25 

In closing, I want again to congratulate and endorse the work of this committee 

and the responsible Members and staff. This bill will go a long way to advance the 

status of preparedness of this country for a threat that is unthinkable but likely. 

I very much appreciate the opportunity to appear before you and look forward to 

your questions. 

Ms. CLARKE. We thank you, Dr. Kadlec, for your testimony here 

today. 

I now recognize Dr. Fischer to summarize her statement for 5 

minutes. 

STATEMENT OF JULIE E. FISCHER, SENIOR ASSOCIATE, GLOBAL HEALTH SECURITY PROGRAM, HENRY L. STIMSON CENTER 

Dr. FISCHER. Thank you. Good afternoon, Madam Chairwoman, 

Mr. Lungren, Mr. Pascrell, distinguished Members of the subcommittee. Thank you very much for giving me the opportunity to 

offer comments on this important piece of legislation. 

Following the anthrax assault of 2001, Congress hardened the 

regulations that governed access to the so-called select agents, 

those pathogens and toxins deemed a serious threat to public 

health and security. The Departments of Health and Human Services and Agriculture administered oversight of the laboratories that 

possessed, used, and transferred these pathogens. 

Since the implementation of the regulations, they have negotiated a delicate balancing act—how to apply the regulations in a 

way that effectively promotes biosecurity without hindering absolutely critical research, which is all the more important, because 

this research builds the public health toolkit that offers us protections from infectious diseases, including those that might be biological weapons. 

Although they are aimed primarily at U.S. laboratories, the select agent regulations and many of the measures here affect international collaborations—research has become a global enterprise, 

and talented researchers within emerging economies increasingly 

engage in collaborative investigations with their U.S. counterparts. 

These professional relationships build trust. They build shared 

norms. They foster open scientific exchange during international 

public health crises. Ultimately, they protect health and safety at 

home and abroad. 

Many of the pathogens on the select agent list cause natural disease outbreaks in Asia, Africa, Latin America. The U.S. and international researchers based in countries where the pathogens are 

prevalent benefit mutually from open partnerships that include 

sharing of knowledge, skills, and specimens. An unknown number 

of U.S. researchers severed such international collaborations following the implementation of the select agent regulations. 

The costs and benefits of security measures that might further 

imperil such collaborations or obstruct cooperation during an international public health crisis must be considered carefully. 

A common criticism of the select agent regulations has been the 

application of a one-size-fits-all security strategy, and the proposed 

legislation would require enhanced biosecurity measures for laboratories using Tier 1 material agents. This is a good start in recognizing that there are tiered levels of biological risks sensitive to the 

context as well as to the pathogens themselves. Greater emphasis 
26 

on risk-based security could allow stakeholders to set priorities 

more effectively. 

The proposed legislation implies that this list will be smaller 

than the current select agent list, specifying only inclusion of bioterrorism risk assessments, as referenced by Dr. Murch, which suggests an evidence-based approach. But the criteria that would be 

used to distinguish these Tier 1 agents from select agents is not yet 

described in detail. 

The legislation does not yet make clear how these new Tier 1 

practices would be managed in relationship to the existing select 

agent regulations at the National institutional level, although those 

standards will be relaxed to those institutions possessing select 

agents newly categorized as lower risk. 

While the awards to offset the increased security costs mentioned 

here at Tier 1 laboratories would be strongly welcomed, it is unclear how risk will be evaluated or whether the organizations that 

receive such funds could use them to help their overseas partners 

comply with any new controls on pathogen acquisition, storage, 

transfer, and use. It is difficult to say, pending that detail, whether 

these measures might further isolate U.S. researchers who are investigating Tier 1 pathogens from their international counterparts. 

The proposed network that would emphasize enhanced customs 

and export regulation and enforcement under DHS emphasize this 

operational relationship to not new authorities, but the committee 

must be aware that in this context the emphasis could reinvigorate 

apprehensions among the research community at home and abroad 

about the open sharing of information resulting from unclassified 

scientific research. 

Biosurveillance systems have now faced new demands to provide 

warning of extraordinary events. As the SARS outbreak demonstrated in 2003, the costs when one nation lacks the ability or 

will to report emerging infectious disease before it spreads across 

borders can be enormous. This outbreak helped catalyze the adoption of the revised international health regulations by the member 

states of the World Health Organization in 2005. 

All 194 state parties are required to strengthen the capacity 

through public health surveillance and response and report any deliberate natural or accidental events that might affect health across 

national borders. 

Unlike other global health initiatives to strengthen capacities, 

these are legally binding. They enjoy widespread international support and complement the objectives of the Biological and Toxin 

Weapons Convention and the recently revised U.S. National security strategy for countering biological threats. 

The United States is also stuck with its efforts to integrate its 

fragmented surveillance from networks, including, as mentioned, 

the National Biosurveillance Integration System and the National 

Biosurveillance Integration Center, an effort slowed at its outset by 

logistical and management challenges. 

In the mean time the Homeland Security Presidential Directive 

21 charged HHS with developing a National biosurveillance strategy for human health HHS. 

As the legislation points out, DHS could play a much stronger 

leadership role in leveraging the operationally useful health-related 
27 

data and information that comes from this surveillance framework 

and existing arbitrary networks, as there are monitoring programs 

for decision-makers across all levels of government. 

Finally, I would just like to say that the situational awareness 

for biological risk depends on capabilities far beyond U.S. borders. 

No nation in an era of accelerated globalization, no matter how 

technologically advanced, can build tall enough walls to keep out 

infectious diseases. This legislation acknowledges the critical need 

for the United States to support capacity building in other nations. 

We already have an endorsement of principles under the National 

strategy for countering biological threats to support principles consistent with the IHR 2005. 

Stressing validated data on biological attacks does not parallel 

the terminology of the IHR and could eventually undermine or 

jeopardize U.S. and National efforts to support implementation of 

the IHR as a common global platform for disease protection and response, including for common biological threats. 

Ms. CLARKE. Dr. Fischer, would you summarize? 

Dr. FISCHER. Yes, ma’am. 

Ms. CLARKE. Thank you. 

Dr. FISCHER. So I would just strongly encourage the committee, 

and I hope that the committee will consider implementing the language within this very necessary legislation whether any measures 

might undermine U.S. support for mitigating risks from natural, 

accidental, or deliberate disease outbreaks under the IHR 2005 

framework and through our collaborations with international partners. Thank you. 

[The statement of Dr. Fischer follows:] 

PREPARED STATEMENT OF JULIE E. FISCHER

JUNE 16, 2010 

Good afternoon, Chairwoman Clarke, Congressman Lungren, Congressman Pascrell, Congressman King, and distinguished Members of the subcommittee. Thank 

you very much for giving me the opportunity to offer comments on H.R. 5498, the 

proposed WMD Prevention and Preparedness Act of 2010. 

National and international responses to biological threats have evolved dramatically in the past decade. Following the anthrax assaults of 2001, Congress created 

legislation to promote biosecurity in the Nation’s research and clinical laboratories, 

and to strengthen National capacities to respond effectively to public health crises. 

Measures broadened the regulations that govern access to ‘‘Select Agents,’’ pathogens and toxins deemed a serious threat to public health and security if released. 

The Department of Health and Human Services (HHS) administers oversight of laboratories that possess, use, or transfer human pathogens on the Select Agent list, 

and the U.S. Department of Agriculture (USDA) serves a parallel role for laboratories that study plant and animal pathogens. These two agencies, together with the 

Departments of Defense, State, and others, have also invested in disease detection 

and response capacities abroad, through jointly owned research programs as well as 

training, funding, and technical assistance. 

Since the implementation of the Select Agent regulations, these agencies and the 

biomedical research community have sought a delicate balance: How to apply the 

regulations in a way that meaningfully enhances biosecurity, without hindering the 

ability of laboratories to conduct legitimate clinical testing and research. The latter 

is all the more significant in that the research under scrutiny ultimately builds the 

public health toolkit of diagnostics, vaccines, and treatments against infectious diseases, including those that might be used as biological weapons. 

Although primarily aimed at U.S. clinical and biomedical research laboratories, 

the Select Agent regulations have affected international collaborations. Life sciences 

research has become a global enterprise, and talented researchers within emerging 

economies increasingly engage in collaborative investigations with their U.S. coun-
28 

terparts. These professional relationships build trust and shared norms, foster open 

scientific exchange during international public health crises, and ultimately protect 

health and safety at home and abroad. Many pathogens on the Select Agent list 

cause natural disease outbreaks in Asia, Africa, and Latin America and the Caribbean. U.S. and international researchers based in countries where such pathogens 

are prevalent benefit mutually from partnerships that include sharing of knowledge, 

skills, and specimens. An unknown number of U.S. researchers severed international collaborations following implementation of the Select Agent regulations, 

impairing progress and reducing the influence of U.S. scientists within international 

communities of practice. The costs and benefits of security measures that might further imperil such collaborations, or obstruct cooperation during an international 

public health emergency, must be weighed carefully. 

The legislation introduced by Congressmen Pascrell and King would address 

many of the lessons learned since 2001, including recommendations by the bipartisan Commission for the Prevention of Weapons of Mass Destruction Proliferation 

and Terrorism. The proposed act recognizes gaps in our abilities to respond to 

events that could jeopardize public health and National security. Public and private 

sector stakeholders in the life sciences still struggle to balance cultures of responsibility and fear in addressing potential vulnerabilities. The proposed legislation confronts another balancing act: How to improve coordination and integration of the 

myriad programs that have evolved to tackle biological threats without creating new 

layers of oversight that might rob existing efforts of their momentum. 

PREVENTION AND DETERRENCE

A common criticism of the Select Agent regulations has been the application of 

a ‘‘one size fits all’’ security strategy to all of the listed pathogens, even though the 

public health, scientific, and security communities recognize a gradient of risks. The 

proposed legislation would require enhanced biosecurity measures for laboratories 

that possess, use, and transfer ‘‘Tier 1 Material Threat Agents.’’ This is a good start 

in recognizing tiered levels of biological risks that are sensitive to context as well 

as pathogen characteristics. Greater emphasis on risk-based security measures 

could allow stakeholders to set priorities more effectively, focusing their resources 

on the subset of laboratories where challenges are most evident. 

The proposed legislation implies that the list of ‘‘Tier 1’’ agents would be smaller 

than the current Select Agent list. The mechanisms described would give broad latitude to the stakeholders in identifying ‘‘Tier 1’’ agents, specifying only the inclusion 

of Bioterrorism Risk Assessments, which suggests an evidence-based approach. 

However, the criteria that would be used to distinguish ‘‘Tier 1’’ agents from Select 

Agents are not described in detail. The legislation would designate the Department 

of Homeland Security (DHS) to lead an interagency rule-making process to develop 

the enhanced biosecurity measures, including laboratory practices. Although a laudable attempt to mandate inclusion of the broader stakeholder community, this could 

further complicate existing dual HHS and USDA oversight. The proposed legislation 

does not describe how these new ‘‘Tier 1’’ practices would be managed in relationship to the existing Select Agent regulations at the National or institutional level, 

or whether standards would be relaxed for institutions possessing Select Agents 

newly categorized as lower-risk. 

The legislation would authorize awards to offset increased security costs at ‘‘Tier 

1’’ laboratories, based on risk. While a welcome response, it is unclear how risk 

would be evaluated, or whether academic and non-profit organizations that receive 

such funds could use them to help overseas partners comply with any new controls 

on pathogen acquisition, storage, transfer, and use. In the absence of such assurance, and pending further detail on the Tier 1 Material Threat Agent determination 

process, it is difficult to say whether these measures might further isolate U.S. researchers investigating Tier 1 pathogens from their international counterparts. 

The proposed network to coordinate customs and export regulation enforcement 

under DHS emphasizes enhanced operational relationships, rather than new authorities. However, in this context—particularly given the reference to ‘‘dual-use’’ 

technologies, a term that includes a broader swath of activities and materials in the 

life sciences than commonly applied to commodities with military applications—this 

emphasis could reinvigorate apprehensions at home and abroad about the open 

sharing of information resulting from unclassified research. 

DETECTION

Biosurveillance systems face new demands to provide warning of extraordinary 

events. In response, stakeholders have expanded their capabilities to detect and 
29 

characterize public health events that could become National, or transnational, 

threats. 

The 2003 SARS outbreak vividly demonstrated the costs when one nation lacks 

the ability or will to report an emerging infectious disease outbreak before it spills 

over borders. The human, political, and economic tolls helped catalyze adoption of 

the revised International Health Regulations by the World Health Organization’s 

member states in 2005 [IHR (2005)]. The IHR (2005) require the 194 state parties 

to strengthen their capacities for public health surveillance and response, and to report any deliberate, natural, or accidental events that might affect health across national borders. The regulations also vested WHO with new authorities to collect and 

share information on such events. Unlike other global health initiatives that aim 

to strengthen capacities for disease detection, assessment, reporting, and response, 

the IHR (2005) are legally binding. They enjoy relatively widespread international 

support, and complement the objectives of both the Biological and Toxin Weapons 

Convention and the recently released U.S. National Strategy for Countering Biological Threats. 

The United States has also stepped up its attempts to integrate its fragmented 

disease surveillance networks. Public Law 110–53 charged DHS with overseeing the 

development and operation of the National Biosurveillance Integration System 

(NBIS), including the National Biosurveillance Integration Center, an effort slowed 

at its outset by logistical and management challenges. Homeland Security Presidential Directive—21 delegated the task of establishing a National biosurveillance 

system for human health to HHS. With input from the interagency Federal Biosurveillance Work Group and other stakeholder committees, the U.S. Centers for 

Disease Control and Prevention (CDC) developed the National Biosurveillance Strategy for Human Health delivered in February 2010. This strategy outlines steps for 

improving the timely, multi-directional flow of health-related information among 

local, State, and Federal stakeholders and with global partners. As implied by the 

proposed legislation, DHS could play a stronger leadership role in leveraging operationally useful health-related data and information for decision-makers across all 

levels of Government. This should build upon the existing National biosurveillance 

strategy for human health, laboratory networks, and biomonitoring programs. 

ATTRIBUTION

The legislation would require public and private entities that have received Federal funding to provide samples of biological agents and toxins for a proposed National bioforensics repository collection. Others here today will doubtless comment 

more comprehensively on the tools for attributing biological attacks to likely perpetrators. I would like to highlight additional sensitivities in including organisms 

derived from international partnerships or collections. 

Many emerging economies already perceive the motives of the U.S. and the international community in collecting specimens for legitimate public health interventions as less than transparent. The proposed repository would explicitly include 

international collections and implicitly encompass agents originally derived by U.S. 

researchers from international partnerships. Including agents that trace their origins to international collaborations, perhaps even to third-party countries, could inflame tensions that already endanger specimen sharing under the IHR (2005) and 

other global disease surveillance agreements. The potential effects on U.S. engagement in global health should be factored into the examination of access and participation issues laid out in the proposed legislation. 

INTERNATIONAL COLLABORATION AND ENGAGEMENT TO ENHANCE BIODEFENSE AND

BIOSECURITY

As recognized by the legislation’s authors and articulated in the recommendations 

of the Commission for the Prevention of Weapons of Mass Destruction Proliferation 

and Terrorism, situational awareness for biological risks depends on capabilities far 

beyond U.S. borders. In an era of accelerated globalization, no nation, no matter 

how technologically advanced, can build tall enough walls to keep out infectious diseases and other public health risks. 

This legislation acknowledges the critical need for the United States to support 

capacity-building in other nations. Many nations will require significant technical 

and financial assistance to strengthen mechanisms for detecting and reporting unusual events that could presage a deliberate, accidental, or natural infectious disease outbreak. A large number of Federal agencies and organizations already play 

key roles in U.S. global health security engagement. The proposed legislation effectively recognizes the unique role of the State Department’s Biosecurity Engagement 

Program. However, other Federal agencies and divisions, including the Department 
30 

of Defense, HHS (including CDC and the National Institutes of Health), USDA, the 

U.S. Agency for International Development (USAID), and elements of the U.S. National laboratories, have significant presence and track records in promoting biosecurity engagement and information exchange abroad. Because these agencies have 

different institutional goals, they have not always pursued coordinated strategies for 

building comprehensive biorisk management. The endorsement of principles consistent with the IHR (2005) in the National Strategy for Countering Biological 

Threats offered a platform for stronger interagency coordination, using an operational framework already shared by international partners. The proposed legislation’s focus on building capacity to report ‘‘validated data on biological attacks’’ to 

United Nations organizations does not parallel the terminology of the IHR (2005), 

which refer to detecting and reporting ‘‘public health emergencies of international 

concern.’’ This might inadvertently jeopardize U.S. and international efforts to support implementation of the IHR (2005) as a common global platform for disease detection and response, including deliberate biological threats. 

International collaboration is an important tool in building shared norms, and 

U.S.-supported capacity-building projects in the life sciences increasingly build longterm partnerships that promote trust, openness, and converging research priorities. 

The proposed legislation acknowledges the benefits of such engagement, directing 

the Secretary of State to support partner nations’ efforts to enhance biosafety and 

biosecurity, taking their own priorities in comprehensive biorisk management into 

account. Language in the proposed provisions that would generally promote datasharing among Federally supported programs abroad for biosecurity purposes might 

reinforce negative perceptions of U.S. transparency and motives. 

INTERAGENCY TASK FORCE ON BEST PRACTICES FOR GLOBAL BIOPREPAREDNESS

The last decade has witnessed a rapid growth of public health preparedness capabilities at home and abroad. Domestically, the United States has supported efforts 

to share lessons learned during events and exercises among first responders in an 

effort to strengthen all-hazards preparedness at the local, State, and Federal levels. 

Clearly, other nations face the same need to build response capabilities across levels 

of government, and many do so without the resources available in the United States 

and other high-income nations. Concerns about exposing homeland security 

vulnerabilities have limited open information-sharing about lessons learned in disaster response with first responders outside of the United States. The United States 

is certainly not the only Nation to hold the results of simulations and self-assessments in public health preparedness close. 

Several recently developed mechanisms answer the need to help nations identify 

and implement best practices to prevent, detect, or respond to biological and other 

catastrophic threats. The IHR (2005), under the aegis of WHO, provide an international forum for assessing and strengthening the global architecture for public 

health preparedness. United Nations Security Council Resolution 1540, through the 

work of the 1540 Committee, provides an information clearinghouse and means for 

capacity building to prevent proliferation of weapons of mass destruction, including 

bioweapons. The United States plays a significant role in assisting partner nations 

with their obligations under these frameworks. 

By authorizing a U.S. interagency task force on global biopreparedness architecture, the legislation would spark a discussion of new developments and persistent 

gaps among a broadly inclusive group of stakeholders. The result, if viewed as a 

map of needs, vulnerabilities, and potential partnerships, could help the United 

States develop a more targeted engagement strategy for building global pathogen 

surveillance and response capacities. It is unclear whether this task force would be 

charged with considering only the architecture for a deliberate biological event, or 

for natural outbreaks and accidental releases as well. It is possible that this task 

force could overlap substantially with activities currently being developed under the 

National Strategy for Countering Biological Threats. It is also possible that recommendations for a global preparedness architecture developed outside of any international forum in which the United States is a key stakeholder may not be adopted 

with wholesale enthusiasm by the international community. 

CONCLUSIONS

Overall, the proposed legislation would address many weaknesses in sharing and 

integration of health-related information domestically, particularly at the State and 

local level. The ‘‘customer base’’ for information on biological hazards has expanded 

dramatically in the past decade, creating new requirements for data analysis and 

dissemination. Stronger integration of public health expertise into the security and 
31 

intelligence communities could help make data on disease threats more relevant for 

strategic and tactical planning across all levels of government. 

Many provisions in H.R. 5498 consider concerns of paramount importance to the 

public health and life sciences communities as well as the security and intelligence 

communities, and carefully recognize the very dynamic nature of the field. This is 

crucial to strengthening a foundation for biorisk management that supports other 

U.S. strategic goals in the long term, whether through a more nuanced response 

that conserves research resources at home, or a coordinated approach to prioritysetting for biosecurity engagement abroad. After years of struggling to find a palatable framework for building truly global disease detection and response capabilities, 

the international community has finally begun to make progress under the IHR 

(2005). The National Strategy for Countering Biological Threats enshrined the U.S. 

commitment to the principles of the IHR (2005), a compact for reciprocal responsibility among nations whose success is not yet guaranteed. As the subcommittee 

moves forward with its deliberations on the proposed WMD Prevention and Preparedness Act of 2010, I hope that it will avoid any measures that might undermine 

U.S. support for mitigating risks from natural, accidental, and deliberate disease 

outbreaks under the IHR (2005) framework. 

Ms. CLARKE. I thank you, too, Dr. Fischer. 

I thank all of our witnesses for their testimony. 

I will remind each Member that he or she will have 5 minutes 

to question the panel. I will now recognize myself for questions at 

this time. 

This question is for the entire panel. We believe there is a need 

to create a top tier of agents in the select agent program that are 

thought to pose material threats to the Nation and therefore should 

be better secured. Tier 1 Material Threat Agents should be secured 

Tier 1 Material Threat Agents. 

In addition to the material threat determination, what other criteria should be used to determine what agent is a Tier 1 Material 

Threat Agent? 

We will start with Dr. Murch. 

Dr. MURCH. I am afraid I don’t have a deep knowledge of the 

processes, but I think one thing that would be important is to incorporate the viewpoints of the operational community, the intelligence community, as opposed to simply the scientific and medical 

community. It is very hard to measure these sorts of criteria that 

the intelligence and operational community use to measure threat, 

for example, but I think it is an important ingredient. 

Dr. KADLEC. I would just highlight that one of the things mentioned in your bill is the biological threat risk assessment. That 

may be a very useful tool to again kind of factor in many of the 

issues that I think Dr. Murch alluded to, and that is the availability of appropriate FDA-approved countermeasures and a variety of other things that can modify your view of what the risk 

would be. Again, I think that is a notable inclusion in your bill on 

that account. 

Ms. CLARKE. Does anyone want to add any other comment? 

Dr. Fischer. 

Dr. FISCHER. I do agree that the intelligence community has a 

strong strategic view. I welcome in this legislation the broader inclusion of the stakeholder community that does include the academic and nonprofit community explicitly, because there are elements of technical achievement and ease of cultivation that should 

be factored in in terms of the ability not only to grow and access 

these agents, but to convert them effectively into a weapon, recog-
32 

nize that that is not always a set of skills at the fingertips of the 

average laboratorian. 

Ms. CLARKE. I just want to say to Dr. Beatrice that it did not 

pass me when you discussed in your testimony the idea of we are 

going to raise a higher level of security for Tier 1 Material Threat 

Agents—there should be some commensurate support for those entities that would have these agents as part of their programs or as 

part of their environs, so that didn’t pass me by. 

Dr. Beatrice, we want to commend you and your colleagues on 

your participation in the BioWatch program, despite some frustration over the years. Can you talk to us about your experience with 

the BioWatch program and how well or how quickly has BioWatch 

data been shared with the New York City Public Health Lab? 

Dr. BEATRICE. Certainly. I will say that my experience with the 

BioWatch program actually started with a phone call from Dr. 

Kadlec in 2003. It was an interesting experience in that the Public 

Health Laboratory was used to supporting environmental and clinical testing, and we were now introduced to the world of biothreat 

in a slightly different way. 

Dr. Kadlec indicated that there was a desire to roll out a new 

program across the country to urban areas and that these were 

going to be secret laboratories that would be installed within public 

health labs. So a growing together of two cultures needed to occur, 

because the concept of the military or law enforcement approach to 

testing and public health were slightly different. 

Our experience has been one in which New York City has had 

a very strong partnership with both the participants at DHS and 

also with our partners at CDC. The initial rollout of the BioWatch 

program was based on a team effort in which the scientists from 

the National labs at DHS and CDC and the New York City Public 

Health Lab worked very closely to ensure that the quality of the 

reagents, the testing, and the training of the individuals would be 

as good as possible. The communications back and forth between 

Federal and local partners was very good. 

I would say that during 2008 and 2009, we entered into a time 

where transparency became almost nonexistent and changes in the 

program that resulted in quality of the reagents were not—we were 

not alerted to those, and what resulted was an increase in some 

challenges in the program. 

It took New York City outreaching again to both DHS and to 

CDC, alerting them to the problems in the program, to really bring 

the process back to one of strong communication and teamwork. 

We are in the process of working through the difficulties in operations. There has been strong commitment on the part of our Federal partners to work through these difficulties, and we are very 

optimistic that we will get to a place that we were in previous 

years. 

Ms. CLARKE. Thank you very much, Dr. Beatrice. My time has 

expired, but we will revisit this. 

I would like to recognize the Ranking Member of the subcommittee, the gentleman from California, Mr. Lungren, for his 

questions at this time. 

Mr. LUNGREN. Thank you very much, Madam Chairwoman. 
33 

Dr. Kadlec, I found your testimony—I found everybody’s testimony—interesting, but I found yours particularly interesting about 

the historical record that President Nixon, his advisors, decided 

that we should not pursue biological weapons, that we should try 

and pursue an effort to unilaterally renounce these weapons and 

support a global ban, but the Soviet Union, under the veil of that, 

continued to press forward. 

So in some ways we took the moral high ground, as we should 

have, but the Soviet Union took advantage of us in that respect 

and proceeded apace and probably had more knowledge about this, 

about the production and so forth. You go on to say in your testimony that we may not know where all of the whereabouts of these 

weapons are. More importantly, the information on the people who 

made them are still in doubt. 

As part of our bill, we stress giving the DNI the responsibility 

for coming together with a comprehensive intelligence approach on 

this. How difficult do you think it will be for us to build that up, 

No. 1? No. 2, how successful do you think we can be with that? 

How immediate is the problem that we address it? 

Dr. KADLEC. To sort of kind of take your answers all in one 

thing, I think a lot more can be done. We have showed a dismal 

record in our intelligence efforts against this problem over the 

many years—decades, if you will, if we had to look at the situation 

with the former Soviet Union. It was a great surprise until a couple 

of defectors came out in the late 1980s, early 1990s, that really 

gave us an understanding of how large and sophisticated that program was. 

I think, similarly, we found ourselves in difficult straits when we 

had to deal with Iraq. Then most recently with al-Qaeda, it is interesting to note that even despite having a public fatwa by Osama 

bin Laden in 1998, and their efforts began in 1999 to include building a dedicated laboratory in Kandahar, Afghanistan, we were unaware of that effort—highly compartmented, parallel effort—until 

2002, when we invaded Afghanistan and uncovered that lab and 

then evidence of those efforts. 

So, quite frankly, we can do a lot better at it. The issue is what 

is it going to take? Well, I think it is going to take priority. It is 

going to take a unified voice between the President and Congress 

and the oversight of Congress to ensure that this issue gets the 

kind of attention and the resources that it deserves. 

It has been a poor stepchild of the nuclear issue. Clearly, we 

have a lot of vivid imageries of the Nagasakis of the world and 

Hiroshimas. Unfortunately, we don’t have one of a biological threat. 

But I note that Henry Kissinger gave a testimony recently about 

the START Treaty and said, ‘‘Well, one day when they wake up 

and hear that, 500,000 people will have died.’’ Then we know from 

the Graham and Talent commission that that likelihood is probably 

going to be a biological event. 

So there is much more that we could do. I think it is going to 

take a joint effort between Congress and the administration to kind 

of keep the interest up, the focus on. Certainly, the oversight role 

of Congress is going to be essential for this. 

Mr. LUNGREN. Dr. Murch. 

Dr. MURCH. Yes, sir. 
34 

Mr. LUNGREN. In terms of the capability that we have in the intelligence community, where are we in that with respect to what 

Dr. Kadlec just talked about? Is there more that we can do in this 

legislation with respect to the intelligence side of things? 

We have made a start, I think, with Title 1, but I happen to personally believe that unless we give the DNI the authority and the 

direction and that is accepted by the other agencies and departments, it is not going to work. 

Dr. MURCH. I agree. 

Mr. LUNGREN. Having seen some recent commentary about DNI 

position thus far, it bothers me. Generally speaking, do you disagree or agree with Dr. Kadlec about the urgency of the matter 

with respect to intelligence, No. 1? 

No. 2, can you comment on what we have in this legislation and 

anything else you think might be important? Because I think all 

parts of this legislation are important, but frankly, if we don’t have 

the intelligence, we cannot prevent and deter. That is the linchpin, 

it seems to me. 

Dr. MURCH. It is indeed a linchpin, and where we should be 

headed is moving our activities to the left, meaning anticipation, 

prevention, interdiction, disruption and so forth, as opposed to the 

reaction, surprise, response, finger-pointing and beyond, way to the 

right, my time-risk continuum. 

Clearly, the DNI has to have the authority. I believe it has to be 

done in a methodical and structured approach. One technique that 

is often used by the Department of Defense is to use what is called 

a systems analysis. Where are we? Where do we need to get to? 

How are we going to get there in a very rigorous, methodical way? 

I think that will be informative to the process. 

I also think we need to think beyond simply state-sponsored programs or sub-state down to a single individual, a lone wolf, which 

is the hardest of the hard problems. How do we scale our intelligence capabilities in an integrated systems fashion, ranging from 

our external collection and analytic and special operations capabilities all the way down to the domestic as well? 

It has to be completely seamless between—very hard, with the 

number of agencies involved and perspectives and cultures, but 

again, under single leadership and commitment by the administration and the Congress and the institutions themselves, and also 

pull upon external resources, because all of the good ideas are not 

in the Federal Government. 

Mr. LUNGREN. Thank you very much. 

Thank you, ma’am. 

Ms. CLARKE. Thank you. 

The Chairwoman now recognizes the gentleman from Ohio, Mr. 

Austria, for his questions at this time. 

Mr. AUSTRIA. Thank you, Madam Chairwoman. 

Thank you to the panel for your testimony today. 

Let me just kind of go back a little bit. I think I was glad to hear 

the last, by Dr. Murch as far as you described moving to the left, 

from preventative standpoint, being prepared for this ahead of 

time, rather than the reactive, which I think is extremely important. 
35 

I guess to the entire panel, I would like to get your thoughts on 

why you think—I know this has been addressed in the past—and 

maybe identify some of the reasons why we haven’t been successful 

in moving in this direction in the past, and why you think this legislation, which I think does a very good job and works towards correcting one of the major deficiencies by expanding the list of entities to which DHS disseminates information to the appropriate different levels, whether it be State, local, and Federal, which I think 

has been a problem in coordinating that communication, why you 

think it would be this—we can be successful this time, and identify 

maybe some of the hurdles that we faced in the past as to why we 

weren’t successful doing this in the past. 

I will open up that to any member of the panel that wants to 

take the start of that. 

Dr. MURCH. I will go first. Certainly, the report by the WMD 

Commission highlights in a more coherent fashion. I think that is 

No. 1. It has been commented on by a number of different sources 

in the media, obviously, here in the Congress, the administration 

and so forth. So I think it is important. 

The problem has been stated and the road ahead has been stated 

in a coherent fashion. Action has been taken quickly by the Congress. I think there is a time now when a unity of purpose can be 

engineered and be sustained, and I haven’t seen it to this point in 

my time in the Government, which for me working on WMD terrorism goes back to the early 1980s when I was a young agent in 

Los Angeles, it turns out. 

But I believe going forward, strategies and plans are important 

for agencies for better collaboration—not simple cooperation, but 

collaboration, not duplicating it, but staying in their lanes and 

doing it well. I think that will help. 

Again, it is leadership. It is oversight. It is measurement of 

progress, which we don’t seem to do very well. We don’t stay focused very well on that. With all due respect, I am not a big believer in simply throwing money at a problem. It is coupling money 

with purpose and measuring effectiveness and holding people accountable. We don’t seem to do that very well either. 

Mr. AUSTRIA. Dr. Murch, let me follow up on that comment, because I think there are those that would argue that this legislation 

is actually going to grow DHS. There is going to be more bureaucracy. You know, then there is the argument of whether that would 

be less efficient, whether it be more wasteful spending or whether 

this would be able to work. I would like to get your comments on 

that, if I could. 

Dr. MURCH. Sure. Well, you begin the legislation, I believe, at the 

right point. You start with the strategy. It is ready, aim, shoot, not 

shoot, ready, aim. Starting with a strategy and planning and reporting and authorities and responsibilities which are embedded in 

that is the right place to start. 

There are clearly a number of other initiatives captured in the 

legislation, which fit underneath that, which are part of a broader 

strategy that is yet to be built. So my hope is is that you are on 

an intelligent strategy. As the Member from New Jersey pointed 

out, we don’t have a comprehensive strategy yet. I think that yet 

has to be constructed and put in place. We are not done yet. 
36 

Mr. AUSTRIA. Dr. Fischer. 

Dr. FISCHER. Thank you, sir. I think that the other part to complement that, as Dr. Murch pointed out, once you have got the information, once you have the tools in place, you also have to have 

the skills integrated to analyze that information and to present it 

in a form that is useful for decision-makers for both operational or 

tactical decision-making and strategic decision-making. The customer base for that kind of information has expanded at the local 

and State level in ways we would never have anticipated only a 

decade ago. 

So I think one of the challenges that this legislation does address 

is expanding the public health intelligence presence at the State 

and local level through mechanisms such as the fusion centers, 

which were intended to do that in the first place. But there are 

operational barriers to that. 

There are professional culture barriers to that that I think will 

not be solved very—you know, they are not going to be solved immediately by simply dictating that there should be that capacity. 

There are obstacles that I think should be explored within those 

communities. 

I also believe that the proposal here to move NVIC, which has 

had its problems, back into the intel portion of the Department of 

Homeland Security, can more effectively move the stream of information there, but only if there are people with the appropriate expertise within that directorate to understand, process, analyze, and 

produce it in a way that is useful for operational decision-making. 

So it is not necessarily growing the agency, but moving the appropriate expertise into that particular division. 

Mr. AUSTRIA. Yes? 

Dr. KADLEC. Sir, very briefly, to answer your question about, you 

know, why we haven’t made more progress. First, it is hard. This 

is not Mother Nature at work. This is a deliberate thing of the 

enemy. It is complicated. Subject to the success of a response to a 

biological event, it is going to be more dependent on people in Sally 

Beatrice’s lab and the funding and the staffing that they have as 

it is whatever the Federal Government is going to do, because they 

are at the tip of the spear. It is expensive. Quite frankly, we have 

not embraced this as a National security issue for our country. 

If we look at the—and again, not to dispute the issue of throwing money at the problem, but what we spend about annually $5 billion. If you ask yourselves what do we spend on nuclear security 

and nuclear defense and offense, it runs about $50 billion, of which 

is that $15 billion is for defensive purposes. If you look at what we 

are going to spend on cyber, it is approaching $30 billion and probably will be $50 billion before too long. 

Somehow we need to recognize that this is not just an extension 

of public health. This is an extension of National security and subject to everything that Congress has done. Congress has done a lot, 

and in no other area that I know of that has Congress done more, 

and more needs to be done. 

But we are subject to a political process, and this notion of imperfect incrementalism is the one we need and, you know, we live 

with. The notion that we will go through other due processes and 

learn by doing imperfectly and adjusting as we have, I think, is a 
37 

pretty extraordinary legacy that Congress has left in this area. 

Thank you. 

Mr. AUSTRIA. Thank you, Madam Chairwoman. I know my time 

is up. Thank you. 

Thank you to the panel. 

Ms. CLARKE. The Chairwoman now recognizes the gentleman 

from New Jersey, the author of this legislation, Mr. Pascrell. 

Mr. PASCRELL. Thank you. 

I just want to bring something to Dr. Murch’s attention, because 

I think you asked very pertinent questions or brought up important 

points about section 2103 in the legislation, which deals with the 

bioterrorism risk assessments. On page 16 under that particular 

section, there is a very specific requirement, which goes to the 

heart of one of the points you are making. 

The Secretary shall convene an interagency task force of relevant 

subject matter experts to provide recommendations to the under 

secretary for science and technology as to the adequacy of the 

methodology—which is in parentheses, your point—used in the assessments and to establish requirements for the standards for 

those assessments. We believe that the National Academy of 

Sciences should be on the task force. I just wanted to make that 

clear. 

Some questions for our panelists. I think we have come a long 

way in the last 5 months, 6 months, on this to bring the legislation 

forward. But I would like to ask Dr. Murch and Dr. Kadlec and Dr. 

Fischer, have we as a country or the world sufficiently criminalized 

acts of bioterrorism and/or biological warfare? 

We have a provision, for instance, in section 402 that seeks to 

address the need to support other countries in criminalizing such 

acts. Would any of you care to respond to that? 

Dr. MURCH. Well, I actually am familiar with that section, and 

I do appreciate that there will be activities in that regard. Clearly, 

in the United States—and I am speaking as a former FBI agent 

working under Federal law—and it seemed to me within the 

United States there is sufficient attention under the law to criminalization of bioterrorism and related acts. 

However, it is a global problem. It is not simply a domestic problem, and we need to work very closely with those countries that we 

usually work with, but also those where we have some concerns 

over their commitment to criminalizing bioterrorism misuse of the 

life sciences. 

Lots of different processes have been undertaken—coordination, 

conferences, discussions and so forth, bilaterals and so on—but we 

have moved all the way up to the Biological Weapons and Toxins 

Convention and the fact that even though it defines illicit behavior, 

there is no enforcement provision. That is something we have to 

contend with, in my mind. 

Mr. PASCRELL. Can you envision any enforcement mechanism? 

Dr. MURCH. Not off the top of my head, actually, sir. But I think 

with the proper discussions, we can probably do that. But obviously, it requires almost uniform international cooperation to get 

there, which has been the struggle. 

Mr. PASCRELL. Let me ask you this question, then. We have seen 

the study of the National Academy of Sciences just last year. That 
38 

study was very explicit—noted that only 2 pages had been dedicated to forensics and homeland security. 

Dr. MURCH. Yes, sir. 

Mr. PASCRELL. I think we could use some more dedicated effort 

in that subject, forensics in homeland security. What do you think 

should be included in such a study? You know we have a provision 

in section 208 that attempts to deal with it. Maybe you feel it is 

adequate or inadequate. 

Dr. MURCH. Yes, sir. I actually was on the committee that is 

strengthening forensic science in the United States, and I actually 

wrote the somewhat limited treatment of forensic science in homeland security. Really by design that study was limited to a very 

short section. 

I believe very strongly—very strongly—that forensic science in 

homeland security—nay, the Department of Homeland Security— 

must be aligned with the directions and expectation that forensic 

science in general is having laid on it. Those provisions in the legislation by the Senate—that is being worked in the Senate Judiciary 

Committee right now, taking on the recommendations of the 

strengthening of forensic science—should be applied to homeland 

security. Homeland security is not special just because it is labeled 

homeland security. So I think an overlay of that kind of treatment 

would be helpful. 

In addition, it has to extend to those special disciplines that are 

somewhat unique in homeland security—bioforensics, nuclear 

forensics. I actually was also on the committee at the National 

academies that has finished up a study on America’s nuclear forensic capability, and that study should be out soon. So it is more embracing. It is more encompassing. It is not simply the role to include innovation, being creative, but also performance in the Department as it stands now. 

Mr. PASCRELL. If I may, Madam Chairwoman? 

Have all of you seen the draft of how we broke down this legislation according to the 13 different departments that are affected? 

Have you all seen that and how each of those departments fall 

under those major areas, as Mr. Austria was pointing out the 

major emphasis on prevention and deterrence and preparedness? 

This was a guideline for us to whenever we got off into the 

clouds, you know, to bring us back down to Earth, because you are 

dealing with multiple departments here. You are trying to get them 

coordinated, which is something new for us, you know. You know, 

in the words of George Kennan when he was talking about this 

great democracy, it needs its tail whacked once in a while so that 

there is movement and progress forward, rather than simply words 

and words and words. 

I am very, very, very glad that we did this this way so that we 

have proper references to the specific 13 recommendations that 

were made by the WMD Commission. We are going—well, probably 

as the Chairwoman will say in a few moments, we will keep the 

record open for any, you know, direction that you folks want to give 

to us. I really want to thank the panel. 

I want to thank the Chair of this committee. Thank you. 

[The information follows:] 
39 

Ms. CLARKE. Thank you, Mr. Pascrell. 

We have been joined by the Chairman of the full committee, Mr. 

Thompson, and without objection the Chairman’s full statement 

will be submitted for the record. 

[The statement of Chairman Thompson follows:] 

PREPARED STATEMENT OF CHAIRMAN BENNIE G. THOMPSON

Today, our Nation is facing a number of different challenges—challenges which 

demand a great deal of attention. There are those who say that we should just concentrate on cleaning up the oil spill in the Gulf, or supporting our military efforts 

in Iraq and Afghanistan, or getting our economy back on track. 

Even in the face of these seemingly overwhelming challenges, we cannot afford 

to turn a blind eye to the ever-present terrorist threat. The attempted Times Square 

and Christmas Day attacks certainly underscore the need to stay vigilant. 

We also need to avoid the ‘‘failures in imagination’’ that the 9/11 Commission 

identified prior to that devastating attack. Now, more than ever, we have to address 
40 

emerging terrorist threats—because our enemies are constantly coming up with innovative ways to attack this Nation. 

That’s why H.R. 5498—the WMD Prevention and Preparedness Act of 2010—is 

so important. With this bipartisan bill, we are telling our enemies that we are taking steps right now to prevent, deter, prepare for, detect, attribute, respond to, and 

recover from a WMD attack. 

By taking this comprehensive approach—addressing homeland security, intelligence, public health, and foreign affairs matters—H.R. 5498 puts us in better 

stead to counter the WMD threat before another attack occurs. 

The bipartisan WMD Commission—with its reports and testimony before this 

committee—has warned us that unless we ‘‘act with great urgency,’’ a WMD terrorist event will occur somewhere in the world by 2013, and that such an event 

would most likely be a biological attack. 

In response, with H.R. 5498, we address the WMD threat in general and the biological threat specifically. The bill has the support of the WMD Commission, but we 

need more than that. 

We need the cooperation of our colleagues on the Hill to help us swiftly pass this 

bill and deliver it to the President for his signature. As the WMD Commission has 

pointed out, we cannot afford to allow turf battles and fights over jurisdiction to 

keep us from doing the right thing by better securing our Nation against the threat 

of WMD. 

Ms. CLARKE. The Chairwoman now recognizes the gentleman 

from Mississippi, the Chairman of the committee, Mr. Thompson, 

for questions. 

Mr. THOMPSON. Thank you very much, Madame Chairwoman. 

I would like to welcome our panel of witnesses. 

I think that the two key points—first of all, Mr. Pascrell, I would 

like to thank you and Mr. King for your leadership on bringing this 

bill forward. It is the right thing to do. Everybody said it should 

have been done in the past, and we have not made it happen. 

But there are a couple of comments, Dr. Beatrice. In your experience have you found that the Federal Government does a decent 

job of sharing the threat information to the State and locals? I understand Mr. Austria here talked a little bit about it. But I am trying to reinforce why this bill is so important that we really—if we 

have not done a good job, then this is an opportunity to do it. I 

would like your opinion again for the record. 

Dr. BEATRICE. Unfortunately, I do not believe the Federal Government has done a good job in information sharing in this area. 

As I said in my testimony, there are times when it is very important for the public health infrastructure to be aware of what bioagents are in place, not only where bioagents are in place, but the 

quality of the biosafety programs that are available in both academic institutions and other institutions within the jurisdiction of 

the public health organizations so that we can outreach to them, 

ensure that the appropriate steps are in place, know what agents 

might be at risk. 

We know that accidental exposure can result in a rather massive 

need for public health response, and yet we do not know how and 

where that response may be needed. Therefore, the public health 

community cannot prepare plans in advance and work with our 

partners in our locales. This information is available in the Federal 

Government and is not being shared. 

Mr. THOMPSON. So basically, I think one of the provisions of this 

bill would mandate that. So clearly, from the initial sponsor of the 

bill, I am sure that was our intent, because so many times when 

situations happen, sometimes the State and locals are the first peo-
41 

ple on the scene, and they need to have access to whatever information that is available. 

Another aspect of this is that with the 9/11 Act, we authorized 

the National Biosurveillance Integration Center. Dr. Kadlec, can 

you give this committee your opinion as to whether or not there 

has been a real use of this entity? 

Dr. KADLEC. Sir, I would just say briefly that it has been a great 

idea that has not lived up to the expectations. Quite frankly, I 

think that challenge has been to basically get the interagency to 

contribute to it, because in the end it really is the assimilation of 

all data, this integration that may exist in public health, that may 

exist in the medical community, may exist from environmental 

sampling, and may exist from a variety of sources that would be 

brought together and evaluated collectively. 

Quite frankly, it has been a historical challenge to have the different agencies come to the table to do that. 

Mr. THOMPSON. So as long as it is sort of a voluntary, come if 

you please effort, the participation is severely lacking. 

Dr. KADLEC. That is correct, sir. 

Mr. THOMPSON. So how would you suggest that Members of Congress fix that? 

Dr. KADLEC. Well, sir, I think by mandating it, No. 1, mandating 

the entity and mandating the participation of the appropriate agencies to participate as part of it. In some ways it was what you said, 

sir—you know, come if you please. 

This is such a critical issue, and I think the recent events, not 

only through the H1N1 pandemic, indicated that situational awareness is kind of like the fog of war. I mean, it really does affect the 

ability of senior policymakers and responders to act in a timely 

fashion, where even in the Gulf spill we know that we have suffered from the imperfect exchanging of information. 

So as much as the information resides in the Federal Government, it does reside in the private sector and the public sector that 

really requires their participation as well. 

Mr. THOMPSON. I thank you, because another one of the points 

in this bill is that we mandate that those agencies participate. So 

again, we are trying to fix the shortcomings of some things that 

clearly we thought would work voluntarily. 

Last point on that—do you think that we should move that center out of the Office of Health Affairs at DHS, or have you looked 

at it in any—— 

Dr. KADLEC. Sir, I am somewhat agnostic to the idea. I think the 

fact of the matter is that need strong leadership. It needs to be in 

a place where the business is information sharing. I think in the 

case that you have identified within the area of DHS that does information sharing and intelligence analysis, that may be a better 

place. 

Certainly, it has not lived up to what it was supposed to be in 

the past, so clearly, there is opportunity, I think, for a little bit of 

experimentation, but it really does require a fair bit of oversight. 

Obviously, it has your attention, sir, and that should go a long way. 

Mr. THOMPSON. Good answer. 

Ms. CLARKE. Thank you, Mr. Chairman. 
42 

I want to thank the witnesses for their valuable testimony and 

the Members for their questions. The Members of the subcommittee may have additional questions for you as witnesses, and 

we ask that you respond expeditiously in writing to those questions. 

Hearing no further business, the subcommittee stands adjourned. 

[Whereupon, at 2:20 p.m., the subcommittee was adjourned.] 

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