[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]


 
       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
                                     

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2011

                     COMMITTEE ON HOMELAND SECURITY

               Bennie G. Thompson, Mississippi, Chairman
Loretta Sanchez, California          Peter T. King, New York
Jane Harman, California              Lamar Smith, Texas
Peter A. DeFazio, Oregon             Daniel E. Lungren, California
Eleanor Holmes Norton, District of   Mike Rogers, Alabama
    Columbia                         Michael T. McCaul, Texas
Zoe Lofgren, California              Charles W. Dent, Pennsylvania
Sheila Jackson Lee, Texas            Gus M. Bilirakis, Florida
Henry Cuellar, Texas                 Paul C. Broun, Georgia
Christopher P. Carney, Pennsylvania  Candice S. Miller, Michigan
Yvette D. Clarke, New York           Pete Olson, Texas
Laura Richardson, California         Anh ``Joseph'' Cao, Louisiana
Ann Kirkpatrick, Arizona             Steve Austria, Ohio
Ben Ray Lujan, New Mexico            Vacancy
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
                    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          Daniel E. Lungren, California
Mary Jo Kilroy, Ohio                 Paul C. Broun, Georgia
William L. Owens, New York           Steve Austria, Ohio
Vacancy                              Peter T. King, New York (Ex 
Bennie G. Thompson, Mississippi (Ex      Officio)
    Officio)
                      Jacob Olcott, Staff Director
       Dr. Chris Beck, Senior Advisor for Science and Technology
                          Ryan Caldwell, Clerk
               Coley O'Brien, Minority Subcommittee Lead


                            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


       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 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 report, 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.

    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 
Prevention 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 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.
    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 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 CDC-funded 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.
    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 All-Hazards 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 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, high-
throughput 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 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 management 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.
    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 non-DHS 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.
    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 sub-strategy 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 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 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 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. Sometimes 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.

            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 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 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 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 FDA-approved 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 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 first-hand 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 rule-making.
    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.
    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.
    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 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 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. counterparts. 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 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 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 long-term 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 data-sharing 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 
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 
priority-setting 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, recognize 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.
    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.
    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.
    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.
    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 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 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:]

    
    
    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 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 people 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.
    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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