[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]


 
                    STRATEGIC PERSPECTIVES OF THE BIOTERRORISM 
                                    THREAT

=======================================================================

                                HEARING

                               BEFORE THE

                            SUBCOMMITTEE ON
                        EMERGENCY PREPAREDNESS,
                      RESPONSE, AND COMMUNICATIONS

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             APRIL 22, 2015

                               __________

                           Serial No. 114-14

                               __________

       Printed for the use of the Committee on Homeland Security
                                     

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                     COMMITTEE ON HOMELAND SECURITY

                   Michael T. McCaul, Texas, Chairman
Lamar Smith, Texas                   Bennie G. Thompson, Mississippi
Peter T. King, New York              Loretta Sanchez, California
Mike Rogers, Alabama                 Sheila Jackson Lee, Texas
Candice S. Miller, Michigan, Vice    James R. Langevin, Rhode Island
    Chair                            Brian Higgins, New York
Jeff Duncan, South Carolina          Cedric L. Richmond, Louisiana
Tom Marino, Pennsylvania             William R. Keating, Massachusetts
Patrick Meehan, Pennsylvania         Donald M. Payne, Jr., New Jersey
Lou Barletta, Pennsylvania           Filemon Vela, Texas
Scott Perry, Pennsylvania            Bonnie Watson Coleman, New Jersey
Curt Clawson, Florida                Kathleen M. Rice, New York
John Katko, New York                 Norma J. Torres, California
Will Hurd, Texas
Earl L. ``Buddy'' Carter, Georgia
Mark Walker, North Carolina
Barry Loudermilk, Georgia
Martha McSally, Arizona
John Ratcliffe, Texas
                   Brendan P. Shields, Staff Director
                    Joan V. O'Hara,  General Counsel
                    Michael S. Twinchek, Chief Clerk
                I. Lanier Avant, Minority Staff Director
                                 ------                                

  SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND COMMUNICATIONS

                   Martha McSally, Arizona, Chairman
Tom Marino, Pennsylvania             Donald M. Payne, Jr., New Jersey
Patrick Meehan, Pennsylvania         Bonnie Watson Coleman, New Jersey
Mark Walker, North Carolina          Kathleen M. Rice, New York
Barry Loudermilk, Georgia            Bennie G. Thompson, Mississippi 
Michael T. McCaul, Texas (ex             (ex officio)
    officio)
             Kerry A. Kinirons, Subcommittee Staff Director
                   Deborah Jordan, Subcommittee Clerk
           Moira Bergin, Minority Subcommittee Staff Director
                           
                           C O N T E N T S

                              ----------                              
                                                                   Page

                               Statements

The Honorable Martha McSally, a Representative in Congress From 
  the State of Arizona, and Chairman, Subcommittee on Emergency 
  Preparedness, Response, and Communications:
  Oral Statement.................................................     1
  Prepared Statement.............................................     3
The Honorable Donald M. Payne, Jr., a Representative in Congress 
  From the State of New Jersey, and Ranking Member, Subcommittee 
  on Emergency Preparedness, Response, and Communications:
  Oral Statement.................................................     4
  Prepared Statement.............................................     6
The Honorable Bennie G. Thompson, a Representative in Congress 
  From the State of Mississippi, and Ranking Member, Committee on 
  Homeland Security:
  Prepared Statement.............................................     6

                               Witnesses

Hon. Jim Talent, Former Senator From the State of Missouri:
  Oral Statement.................................................     8
  Prepared Statement.............................................    10
Mr. Charles B. Cairns, M.D., Interim Dean, Health Sciences 
  Center, University of Arizona College of Medicine:
  Oral Statement.................................................    14
  Prepared Statement.............................................    15
Ms. Marisa Raphael, Deputy Commissioner, Office of Emergency 
  Planning and Response, New York City Department of Health and 
  Mental Hygiene:
  Oral Statement.................................................    21
  Prepared Statement.............................................    23


           STRATEGIC PERSPECTIVES OF THE BIOTERRORISM THREAT

                              ----------                              


                       Wednesday, April 22, 2015

             U.S. House of Representatives,
 Subcommittee on Emergency Preparedness, Response, 
                                and Communications,
                            Committee on Homeland Security,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:07 a.m., in 
Room 311, Cannon House Office Building, Hon. Martha McSally 
[Chairman of the subcommittee] presiding.
    Present: Representatives McSally, Walker, Payne, and Rice.
    Ms. McSally. The Subcommittee on Emergency Preparedness, 
Response, and Communication will come to order.
    The subcommittee is meeting today to receive testimony 
regarding the bioterrorism threat.
    Before I recognize myself for an opening statement, I want 
to acknowledge a special guest of the subcommittee today. I am 
pleased to have my goddaughter, Clare, joining us. She is 
shadowing me all day today to see what it is like to be serving 
in the House of Representatives.
    I now recognize myself for an opening statement.
    This morning, the Subcommittee on Emergency Preparedness, 
Response, and Communications will continue its examination of 
preparedness for the CBRN attacks to the homeland, with a focus 
on the threat of bioterrorism. It is what I hope will be the 
first conversation of many that this subcommittee will hold on 
biodefense. I intend for us to really dig into all aspects of 
biopreparedness, both for terrorism and pandemics or other 
emerging infectious diseases.
    We received a Classified briefing last week on the threat 
of biological and chemical terrorism. How we prevent and 
prepare for WMD terrorism is a key area of oversight for the 
full Committee on Homeland Security, as it is for this 
subcommittee. Our Nation's capacity to mitigate the impacts of 
all types of biological events is a top National security 
priority.
    Though many of us are new to this subcommittee or to 
Congress, we are not new to the issue of biodefense. I have 
personal interest in this area. I have a biology degree from 
the Air Force Academy, by the way, but I deployed six times, 
though, to combat zones during my military service, four of 
those deployments after 9/11. I was deployed to Saudi Arabia in 
the Middle East during the anthrax scare of 2001. I can tell 
you, in the military, we even were not prepared to deal with 
this threat at that time.
    On subsequent deployments, I personally received a number 
of vaccines, to include the anthrax vaccine, smallpox, and we 
were on continuous antibiotics on my last deployment to 
Afghanistan. So, as we were responding militarily, we were 
poking and prodding all of our troops, making sure, you know, 
that we were ready to go for any of the common threats we 
thought were out there.
    But that makes me wonder, just like when we talked about 
the chemical terrorism threat, obviously we can't have that be 
going on for everybody at home, so what do we need to do, you 
know, to protect the homeland and our society? So that is why 
it is imperative that we have a system in place and we exercise 
it, to detect and communicate and respond to this threat, to 
include the distribution of medical countermeasures.
    We understand an attack using biological agents or weapons 
is a low-probability but high-consequence event. A bio-attack 
could cause illness or death in hundreds of thousands of 
people, overwhelm our public health capabilities, and have an 
economic impact of over $1 trillion per incident. Furthermore, 
we know there would be a myriad of significant societal and 
political consequences.
    We also understand, thanks to experts such as those that 
are appearing today before us, that bioterrorist attacks are an 
urgent and a continuing threat. The Director of National 
Intelligence testified in February that weapons of mass 
destruction continue to be a major threat to security of the 
United States. He noted that biological and chemical materials 
and technologies, as well as personnel with expertise to use 
and design them, move easily in the economy. The DNI also 
stated that infectious disease continues to threaten our 
security, that a more crowded and interconnected world is 
increasing the opportunities for human and animal diseases to 
emerge and spread globally.
    The hearing this subcommittee held last month highlighted 
challenges related to mass-casualty management as it pertains 
to a chemical event. Bio would be equally as challenging, with 
the added problem of illness taking days or weeks to present 
symptoms sometimes.
    Because of the legitimate and important life sciences 
reasons to do research with biological agents, we may not 
always be able to stop our enemies from developing a biological 
weapon. Therefore, we must have a robust preparedness and 
response infrastructure in place. The ability of our health 
system to respond is of critical importance.
    There has been a lot of solid work in assessing 
biopreparedness over the years, and I am very grateful to 
Senator Talent, co-chair of the WMD Commission, for being here 
to share this history and discuss why we seem to be almost 
stuck in place and time, unable to take steps toward change and 
enhancing our resiliency in this area.
    In preparing for today's hearing, I reviewed this history, 
and I am honestly surprised and actually shocked that some of 
the recommendations made 6 or 8 years ago have not been 
implemented and that, even after the Ebola response, if we can 
call it that, we cannot seem to identify the Federal official, 
the one Federal official, who has the responsibility and the 
authority to coordinate the dozen or so senior officials whose 
responsibility it is for biological preparedness and defense. 
It is just baffling to me.
    Beyond today's hearing, we will look at disease 
surveillance, detection, diagnosis, and reporting; we will 
receive a report from the formidable Blue Ribbon Study Panel on 
Biodefense, which plans to issue recommendations for changes to 
U.S. law and policy later on this year; and we will dive deeper 
into roles and responsibilities in the biodefense space.
    But today is all about the threat. Last year, General 
Clapper stated that the intelligence community assessed that 
Syria's biological warfare program, ``might have advanced 
beyond the research and development stage and might be capable 
of limited agent production''.
    In addition to the concern of the Syrian regime using 
biological weapons, we must also be concerned about ISIS and 
its affiliates getting ahold of them. As I have stated before, 
ISIS is better-resourced, more brutal, and more organized than 
any terrorist organization to date. We know they have an 
interest in using chemical and biological weapons. In fact, a 
laptop reportedly retrieved from an ISIS hideout in Syria last 
year contained plans for weaponizing bubonic plague and a 
document discussing the advantages of using biological weapons.
    We have a very distinguished panel of witnesses here today 
to discuss this threat. I am hoping to hear from each of you. I 
want to know what keeps you up at night. How can we best 
position the Federal Government to respond to the threat of a 
biological attack?
    [The statement of Chairman McSally follows:]
                  Statement of Chairman Martha McSally
                             April 22, 2015
    This morning, the Subcommittee on Emergency Preparedness, Response, 
and Communications will continue its examination of preparedness for 
CBRN attacks to the homeland, with a focus on the threat of 
bioterrorism. It is what I hope will be the first conversation of many 
that this subcommittee will hold on biodefense. I intend for us to 
really dig into all aspects of bio preparedness, both for terrorism and 
pandemics or other emerging infectious diseases. We received a 
Classified briefing last week on the threat of biological and chemical 
terrorism. How we prevent and prepare for WMD terrorism is a key area 
of oversight for the full Committee on Homeland Security as it is for 
this subcommittee. Our Nation's capacity to mitigate the impacts of all 
types of biological events is a top National security priority.
    Though many of us are new to this subcommittee or to Congress, we 
are not new to the issue of biodefense. I have a personal interest in 
this area and a background in biology. I deployed six times to combat 
zones during my military service, with four of those deployments 
occurring after September 11. I was deployed in the Middle East during 
the Anthrax scare in 2001, and I can tell you that even we in the 
military weren't prepared for that. On subsequent deployments, I 
received a number of vaccines to counter biological agents and on my 
last deployment to Afghanistan they had us taking antibiotics every day 
to counter the potential for biological attacks on troops.
    Obviously, we can't have everyone in America taking similar 
precautions every day. That is why it is imperative to have a system in 
place and exercised to detect, communicate, and respond to these 
threats, including the distribution of medical countermeasures. We 
understand that an attack using biological agents or weapons is a low-
probability, high-consequence event. A bio attack could cause illness 
or death in hundreds of thousands of people, overwhelm our public 
health capabilities, and have an economic impact of over one trillion 
dollars per incident. Furthermore, we know there would be myriad 
significant societal and political consequences. We also understand, 
thanks to experts such as and including those before us today, that 
bioterrorist attacks are an urgent and continuing threat.
    The Director of National Intelligence testified in February that 
weapons of mass destruction continue to be a major threat to the 
security of the United States. He noted that biological and chemical 
materials and technologies, as well as personnel with the expertise to 
use and design them, move easily in the economy. The DNI also stated 
that infectious disease continues to threaten our security and that a 
more crowded and interconnected world is increasing the opportunities 
for human and animal diseases to emerge and spread globally.
    The hearing this subcommittee held last month highlighted 
challenges related to mass casualty management as it pertains to a 
major chemical event. Bio would be equally as challenging, with the 
added problem of illness that takes days or weeks to present symptoms. 
Because of the legitimate and important life-sciences reasons to do 
research with biological agents, we may not always be able to stop our 
enemies from developing a biological weapon. Therefore, we must have a 
robust preparedness and response infrastructure in place. The ability 
of our health system to respond is of critical importance.
    There has been a lot of solid work in assessing bio preparedness 
over the years and I'm very grateful to Senator Talent, co-chair of the 
WMD commission, for being here to share this history and discuss why we 
seem to be almost stuck in place--unable to take steps toward change 
and enhanced resiliency in this area.
    In preparing for today's hearing, I've reviewed this history and I 
am honestly surprised that some of the recommendations made 6 and 8 
years ago have not been implemented, and that even after the Ebola 
response we cannot seem to identify the Federal official who has the 
responsibility and authority to coordinate the dozen or so senior 
officials with responsibility for biological preparedness and defense. 
It's just baffling.
    Beyond today's hearing, we'll look at disease surveillance, 
detection, diagnosis, and reporting. We'll receive a report from the 
formidable Blue Ribbon Study Panel on Biodefense, which plans to issue 
recommendations for changes to U.S. law and policy later this year. And 
we will dive deeper into roles and responsibilities in the biodefense 
space.
    But today is all about the threat. Last year, General Clapper 
stated that the intelligence community assessed that Syria's biological 
warfare program ``might have advanced beyond the research and 
development stage and might be capable of limited agent production.'' 
In addition to the concern of the Syrian regime using biological 
weapons, we must also be concerned about ISIS getting ahold of them.
    As I have stated before, ISIS is better resourced, more brutal, and 
more organized than any terrorist group to date. We know that they have 
an interest in using chemical and biological weapons. In fact, a laptop 
reportedly retrieved from an ISIS hideout in Syria last year contained 
plans for weaponizing bubonic plague and a document discussing the 
advantages of using biological weapons.
    We have a very distinguished panel of witnesses here today. I am 
hoping to hear from each of you: What keeps you up at night? How can we 
best position the Federal Government to respond to the threat of a 
biological attack?

    Ms. McSally. Before I get to the panel, the Chairman now 
recognizes the gentleman from New Jersey, Mr. Payne, for an 
opening statement.
    Mr. Payne. Good morning.
    I want to thank Chairman McSally for continuing this 
subcommittee's work on ensuring that we understand and are 
prepared to respond to the threats posed by bioterrorism.
    Just over a year ago, this subcommittee examined the 
history of bioterrorism threats, how bio-threats are evolving, 
and whether the Federal Government is doing what it needs to to 
prevent and effectively respond to acts of bioterrorism. The 
message from the hearing was clear: When it comes to 
biodefense, there is a leadership vacuum.
    Ten months after the hearing, that leadership vacuum became 
publicly apparent as the Federal Government struggled to 
effectively coordinate its response to the U.S. Ebola case. 
Despite billions of dollars of investment in developing 
capabilities to prevent and respond to bioterror events, the 
lack of comprehensive Federal strategy effectively coordinated 
by someone at the highest level of Government undermines every 
dollar we spend.
    That is why, last Congress, I supported the WMD Prevention 
and Preparedness Act, which was introduced by my colleague from 
New Jersey, Congressman Bill Pascrell, and the former Chairman 
of Homeland Security, the Honorable Peter King. That 
legislation would have implemented recommendations that were 
made in 2008, WMD Commission Report, and, importantly, 
reestablished the position of Special Assistant to the 
President on Biodefense. Although the bill did not move in this 
committee last Congress, I am hopeful that it will be 
reintroduced and that the lessons learned from the Ebola crisis 
last fall will incentivize this committee and Congress to act 
on it.
    As I have observed throughout my tenure in Congress, the 
attention of this body and its Federal partners ebbs and flows 
from crisis to crisis. I hope that we address the 
biopreparedness gaps we have observed last year before we 
become complacent and the next crisis shocks us back into 
action.
    Along those lines, I am interested to hear Senator Talent's 
views on the threats posed by bioterrorism and the potential of 
lone-wolf actors and how we should prioritize our efforts with 
respect to addressing bio-threats.
    Despite some challenges at the Federal level, I am 
encouraged to hear about efforts local public health 
departments are undertaking to ensure that they will be able to 
protect the public should a bio-event occur.
    Additionally, I would like to commend Deputy Commissioner 
Raphael on New York City's successful response to the Ebola 
case last fall. I am interested in understanding how the city 
became prepared to respond so effectively and whether 
information shared by the Federal Government was consistent, 
coordinated, and useful.
    Before an Ebola case was diagnosed in the United States, 
New York City was working to improve its bio-response 
capabilities by testing its plans to rapidly deploy 
countermeasures following an anthrax attack in its largest no-
notice emergency response exercise to date. I am interested in 
learning about how lessons learned from previous exercises 
informed the plans tested last summer, what New York City 
learned from the August exercise, and whether the lessons 
learned are being shared with neighboring jurisdictions.
    Finally, I would note that our counterparts on the 
Appropriations Committee are in the process of drafting the 
fiscal year 2016 funding bill as we speak. I would be remiss if 
I did not take the opportunity to highlight the important role 
grant programs like the Urban Areas Security Initiative, also 
known as UASI, have played in developing local capabilities to 
prepare to respond to bio-threats. I urge our colleagues to 
provide robust funding for UASI and to consider restoring 
funding for reduced or expired grant programs that bolster 
medical response capabilities, such as the Metropolitan Medical 
Response System.
    I would like to thank the witnesses for being here today, 
and I look forward to your testimony.
    With that, Madam Chairman, I yield back.
    [The statement of Ranking Member Payne follows:]
            Statement of Ranking Member Donald M. Payne, Jr.
                             April 22, 2015
    I want to thank Chairman McSally for continuing the subcommittee's 
work on ensuring that we understand--and are prepared to respond to--
the threats posed by bioterrorism. Just over a year ago, this 
subcommittee examined the history of bioterrorism threats, how bio-
threats are evolving, and whether the Federal Government is doing what 
it needs to do to prevent and effectively respond to acts of 
bioterrorism.
    The message from that hearing was clear: When it comes to 
biodefense, there is a leadership vacuum. Ten months after the hearing, 
that leadership vacuum became publicly apparent as the Federal 
Government struggled to effectively coordinate its response to the U.S. 
Ebola cases.
    Despite billions of dollars of investment in developing 
capabilities to prevent and respond to a bioterror event, the lack of a 
comprehensive Federal strategy effectively coordinated by someone at 
the highest level of Government undermines every dollar we spend.
    That is why last Congress, I supported the WMD Prevention and 
Preparedness Act, which was introduced by my New Jersey Colleague, 
Congressman Bill Pascrell, and former Chairman Peter King. That 
legislation would have implemented the recommendations made in the 2008 
WMD Commission Report and, importantly, re-established the position of 
Special Assistant to the President on Biodefense. Although the bill did 
not move in this committee last Congress, I am hopeful that it will be 
reintroduced, and that the lessons learned from the Ebola crisis last 
fall will incentivize this committee and Congress to act on it.
    As I have observed throughout my tenure in Congress, the attention 
of this body and its Federal partners ebbs and flows from crisis to 
crisis, and I hope that we address the bio-preparedness gaps we 
observed last year before we become complacent and the next crisis 
shocks us back into action.
    Along those lines, I am interested to hear Senator Talent's views 
on the threats posed by bioterrorism, the potential of lone-wolf 
actors, and how we should prioritize our efforts with respect to 
addressing bio-threats. Despite some challenges at the Federal level, I 
am encouraged to hear about efforts local public health departments are 
undertaking to ensure that they will be able to protect the public 
should a bio-event occur.
    Initially, I would like to commend Deputy Commissioner Raphael on 
New York City's successful response to the Ebola case last fall, and I 
will be interested in understanding how the city became prepared to 
respond so effectively and whether information shared by the Federal 
Government was consistent, coordinated, and useful.
    Before an Ebola case was diagnosed in the United States, New York 
City was working to improve is bio-response capabilities by testing its 
plans to rapidly deploy countermeasures following an anthrax attack in 
its largest, no-notice emergency response exercise to date. I am 
interested in learning about how lessons learned from previous 
exercises informed the plans tested last summer, what New York City 
learned from the August exercise, and whether the lessons learned are 
being shared with neighboring jurisdictions.
    Finally, I would note that our counterparts on the Appropriations 
Committee are in the process of drafting the fiscal year 2016 funding 
bills as we speak. I would be remiss if I did not take this opportunity 
to highlight the important role grant programs like the Urban Area 
Security Initiative have played in developing local capabilities to 
prepare for and respond to bio-threats.
    I urge our colleagues to provide robust funding for UASI and to 
consider restoring funding for reduced or expired grant programs that 
bolstered medical response capabilities, such as the Metropolitan 
Medical Response system.

    Ms. McSally. Great. Thank you.
    Other Members of the subcommittee are reminded that opening 
statements may be submitted for the record.
    [The statement of Ranking Member Thompson follows:]
             Statement of Ranking Member Bennie G. Thompson
                             April 22, 2015
    Last month, this subcommittee examined efforts to bolster the 
ability of Federal, State, and local governments to respond to chemical 
terrorism. I am pleased that the subcommittee is now taking the 
opportunity to assess bio-terrorism threats and our ability to prevent 
and respond to such attacks.
    One of the key recommendations that the 9/11 Commission made to 
Congress was to address the grave threat posed by the proliferation of 
weapons of mass destruction. Accordingly, when I was Chairman of this 
committee, we authorized the Commission for the Prevention of Weapons 
of Mass Destruction Proliferation and Terrorism, or the WMD Commission, 
on which Senator Talent--who is here with us today--served as vice 
chair.
    In 2008, the WMD Commission issued a report making a series of 
recommendations to address WMD threats, particularly bioterrorism. 
Unfortunately, the Federal Government has been slow to respond.
    In 2010, a WMD Commission progress report gave the U.S. Government 
an ``F'' for failing to do enough to prevent a biological attack on the 
United States or to be able to respond effectively in the event of a 
biological attack.
    In 2011, the WMD Center found that the United States was still 
unprepared to detect and respond to a large-scale biological attack, 
despite upwards of $60 billion invested in developing those 
capabilities. The Federal Government's failure to implement appropriate 
policies and build the robust governance infrastructure necessary to 
tackle biological threats came to a head last fall when an Ebola victim 
sought treatment in a Texas hospital.
    In addition to public concern, evolving guidance regarding 
appropriate PPE for hospital staff, and inconsistent quarantine polices 
at the State and local level, it was unclear who in the Federal 
Government was in charge of developing, and coordinating the 
implementation of, policies to contain the virus and ensure that the 
sick could be treated safely.
    The response structure was seemingly lacking. Nevertheless, 
although the Federal response to a low number of Ebola cases in the 
United States was somewhat stilted, it was successful. I worry, 
however, that we would not be so lucky in the event of a biological 
attack. It has been nearly 7 years since the WMD Commission released 
its report and recommendations, and 3 years since the WMD Center 
released its damning report card of our National Bio-Response 
Capabilities.
    During that time, Congressman Pascrell and former Chairman King 
have introduced the WMD Prevention and Preparedness Act, which would 
implement many of the WMD Commission's recommendations, three times. 
Unfortunately, the bill has never been enacted. In the absence of a 
comprehensive legislative remedy to our bioterrorism capability gaps, I 
will be interested in learning whether our witnesses believe we have 
made any progress in improving our response to bio-threats over the 
past several years. I am also interested to know how State and local 
governments address bioterrorism threats.

    Ms. McSally. We are pleased to have a very distinguished 
panel before us today on this important topic.
    Senator Jim Talent has been active in public policy for the 
past 30 years, including representing Missouri in both the U.S. 
Senate and the U.S. House of Representatives.
    Following his service in the Senate, Senator Talent served 
as the co-chair of the Commission on the Prevention of Weapons 
of Mass Destruction Proliferation and Terrorism. Following the 
expiration of the WMD Commission's authorization in 2009, 
Senator Talent joined Senator Graham, the chairman of the WMD 
Commission, in establishing the Bipartisan WMD Terrorism 
Research Center.
    Senator Talent is also a senior fellow and director of the 
National Security 2020 Project at the American Enterprise 
Institute. Senator Talent has a B.A. from Washington University 
in St. Louis and a J.D. from the University Chicago Law School.
    Dr. Charles, or ``Chuck,'' Cairns is an interim dean at the 
University of Arizona College of Medicine in my district and 
the assistant vice president of the Arizona Health Sciences 
Center. He previously served as a chair of the Department of 
Emergency Medicine at the University of North Carolina and as 
director of emergency research at the Duke Clinical Research 
Institute.
    Dr. Cairns has been a clinician, educator, investigator, 
and leader in emergency care, focused upon the host responses 
of individual patients and populations to acute medical 
conditions. Dr. Cairns was principal investigator of the 
National Collaborative for Bio-Preparedness and the director of 
the U.S. Critical Illness and Injury Trials Group. He has 
published over 150 scientific articles and reviews and has 
received numerous awards and honors.
    Dr. Cairns is an honors graduate of Dartmouth College and 
the University of North Carolina. He completed an emergency 
medicine residency and EMF research fellowship at the Harbor-
UCLA Medical Center. Dr. Cairns is board-certified in emergency 
medicine and a fellow of the American College of Emergency 
Physicians, the American Academy of Emergency Medicine, and the 
American Heart Association.
    I now yield to the Ranking Member to introduce our third 
witness.
    Mr. Payne. Thank you, Madam Chairman.
    It is my distinct honor to introduce Marisa Raphael, who is 
the deputy commissioner of the Office of Emergency Preparedness 
and Response at the New York City Department of Health and 
Mental Hygiene.
    Ms. Raphael's responsibilities include directing and 
coordinating all operational, all administrative aspects of the 
department's emergency preparedness and response activities, 
including overseeing the coordination of public health 
emergency preparedness planning for New York City's health care 
system. In other capacities at the Office of Emergency 
Preparedness and Response, Ms. Raphael has overseen emergency 
planning exercises and training and countermeasures planning.
    Ms. Raphael received her master's of public health from the 
University of Michigan. She also attended the Harvard Kennedy 
School of Government Senior Executives in State and Local 
Government Program and Harvard's National Preparedness 
Leadership Initiative.
    Welcome.
    Ms. McSally. Thank you.
    Welcome to all the witness.
    The witnesses' full written statements will appear in the 
record.
    The Chairman now recognizes Senator Talent for 5 minutes.

STATEMENT OF HON. JIM TALENT, FORMER SENATOR FROM THE STATE OF 
                            MISSOURI

    Mr. Talent. Thank you, Madam Chairman.
    I want to thank you and the Ranking Member and all the 
Members of the subcommittee for your interest in this subject. 
It is personally quite encouraging to me because I do have a 
history with it, and you are right in believing that it does 
present a very grave threat and that we are not responding as 
well as we could.
    I am going to summarize very briefly. I know you probably 
have a lot of questions and it will help you more to ask 
questions than for us just to talk.
    A little bit on the history, and I know the subcommittee is 
aware of it, so I will be brief. Senator Graham and I were 
asked in 2007 to co-chair the Task Force on WMD Proliferation 
and Terrorism. We met with Senator Reid, the Majority leader in 
the Senate at the time, and he urged us to consider the mandate 
to be a broad one, to identify the areas where we felt Congress 
needed to know something that had not been highlighted enough, 
and to tell it to the Congress, you know, without any varnish 
on it, just to say it as it was. So we did that.
    As we began our work, we decided to focus on the nuclear 
and the bio-threat. As we continued through our initial 
deliberations, the bio-threat kept emerging in the minds of 
everybody on the Commission, most of whom were nuclear experts, 
by the way, as actually the graver threat of the two--which, of 
course, is not to downgrade the danger of the use of a nuclear 
device against us--for several reasons.
    One, the bio-threat is potentially as destructive as the 
use of a nuclear device. You have had the briefing; you know 
that. Second, we had direct intelligence that al-Qaeda was 
aware of the potential of a bio-threat. They had a lab in 
Afghanistan. They were trying to develop it. Third, we thought 
that acquiring and deploying a bioweapon was actually more 
within their capabilities than acquiring and deploying a 
nuclear device because advances in life science, which have 
done so much to, you know, improve the quality of human life, 
also have lowered the bar for the production and deployment of 
the bioweapon.
    Now, it used to be that was only within the ability of a 
nation-state to do this. It was developed originally and then 
discarded as a battlefield weapon. But, now, if you can recruit 
a competent life scientist and get a lab at a cost of several 
hundred thousand dollars, it is entirely plausible that that 
life scientist can isolate and weaponize a deadly bio-agent. We 
said in the report, I think, that we were less concerned about 
the terrorists becoming biologists than we were concerned about 
biologists becoming terrorists.
    So we said that in the report. We made a number of 
recommendations. Congress then asked us to come back and do 
another report on the status of our recommendations. This was 
the first one. We did the second one. In the course of doing 
that one, we focused on the issue of preparedness for a bio-
attack, and, again, for a couple reasons, one of which is, 
obviously, if there is an attack, we want to limit the loss of 
life as much as possible. The second was our feeling that, to 
the extent that we can really prepare and harden the target, if 
you will, we could actually deter such an attack. We can make 
bioweapons no longer weapons of mass destruction.
    So we issued the second report. Then, at the urging of the 
other commissioners, Senator Graham and I formed a nonprofit, 
which did the first ever--and, I think, the only one, to this 
date--end-to-end strategic study of all the links in what we 
call the chain of resilience. We recruited the best experts to 
formulate the right questions so that we knew what metrics we 
could use in judging the resiliency of the system, and we 
recruited another set of experts to answer those questions.
    Then we issued this report, the ``Bio-Response Report 
Card.'' We tried to be fairly nuanced, to issue grades across a 
spectrum of different kinds of potential attacks. We did that 
in 2011.
    My time is running out. I will just say, you have focused, 
I think, your subcommittee on the areas that concerned us the 
most.
    We are not stockpiling as well as we should. We have made 
some progress since then. But, to the extent that we can 
stockpile against the most likely agents, then we force anybody 
who is actually planning this to try and come up with agents 
that are harder for them to come up with, so we raise the bar. 
FDA has made some progress in trying to develop the technology 
to be able to go from bug to drug quickly, but they need to 
work harder on that.
    I was also--two more things, very briefly. I may run just a 
little bit over. But one of them--I was personally concerned 
with our distribution system very much. I am going to be very 
eager to hear what the deputy commissioner has to say because, 
to me, as a representative and a public official, the idea of 
these drugs being available and us not having an adequate 
system for dispensing them to people, think of the panic, think 
of what would happen to the social fabric if people knew they 
needed these countermeasures for their families and they 
couldn't get them. I mean, I don't want to think what would 
happen under those circumstances.
    Finally, Senator Graham and I felt free, having served in 
this body, to be very clear and direct about recommendations 
regarding changing the way the Government approaches this in 
both the Executive and the Legislative branch. Leadership is 
too fragmented, and, if anything, Madam Chairman, to be fair to 
the Executive branch, it is worse here than it is over there.
    We all know the problem. We know it is difficult to solve. 
I was a Chairman myself. I am not underestimating that. But we 
need to make an effort. If I had the Speaker and the Leader 
here and the Majority and Democratic leaders of the Senate 
here, I would tell them exactly the same thing.
    So I hope that a movement towards that comes out of this. 
Bob and I understand that Congress is not an obstacle in this 
kind of thing; Congress can be a tremendous influencer for good 
in the workings of the Executive branch. But Congress has to be 
able to operate, and it can't with this jurisdictional setup.
    I ran a little bit over, but not bad for a former Senator, 
though. I mean----
    Ms. McSally. Very impressive, actually.
    Mr. Talent. Thank you so much.
    [The prepared statement of Hon. Talent follows:]
                 Prepared Statement of Hon. Jim Talent
                             April 22, 2015
    Madame Chairman, Ranking Member Payne, and Members of the 
subcommittee, it's a pleasure for me to appear before you today, and 
quite encouraging to me personally that you are holding a hearing on 
this subject. Congress cannot pay too much attention to the fact that 
we live in an era of information technology which has, unfortunately, 
greatly increased the danger to the United States and the world of 
asymmetric weapons: Weapons which have a destructive potential that is 
highly disproportionate to the power and resources it requires to 
develop and deploy them. Of the asymmetric dangers we face, the threat 
of a bio-attack is, in my judgment, one of the greatest and gravest.
    I will address that subject later in my testimony. First I want to 
describe how I came to be familiar with this issue.
    One of the recommendations of the 9/11 Commission was that Congress 
focus on the danger of weapons of mass destruction proliferating to 
terrorist groups. So in 2007 Congress created a Commission to study the 
danger and report on measures that could be taken to minimize it. I was 
asked to co-chair the Commission with Senator Bob Graham of Florida. 
There were a total of 9 members on our bi-partisan Commission.
    Shortly after our Commission was formed, we met with Senator Harry 
Reid at his request. Senator Reid explained his interest in the subject 
of our work, and encouraged us to highlight clearly those aspects of 
the WMD terrorism threat which we believed were the most significant; 
he urged us in the strongest terms to tell us what we thought Congress 
most needed to know about the danger. We did so in a Report released at 
the end of 2008 called ``World at Risk.''
    Early in our deliberations, Senator Graham and I decided to focus 
on the threat posed by nuclear and biological weapons, and if anything 
to give the bio-threat greater emphasis. There were two primary reasons 
for that:
    First, we knew that the terrorists had pursued bio-weapons in the 
past. Former CIA director George Tenet noted in his memoir that in 
connection with their planning of the 9/11 attacks, al-Qaeda launched a 
concerted effort to obtain and weaponize anthrax to use in a mass 
attack. They set up a biological laboratory for that purpose in 
Afghanistan and hired Yazid Sufaat, a former Malaysian Army officer who 
had been trained in microbiology at California State University, 
Sacramento. Fortunately, their efforts were derailed by the American 
invasion of Afghanistan, but the record showed that they were aware of 
the potential of bio-weapons for their purposes. Others such as al-
Qaeda of the Arabian Peninsula (AQAP) have expressed similar intent.
    Second, we judged that it was probably easier for them to secure a 
bio-weapon than a nuclear weapon. Before the information revolution, it 
required the resources of a nation-state to develop and deliver a bio-
weapon. But the tremendous advances in life science over the last few 
decades, which have done so much to advance the quality of human life, 
have had the ironic side effect of reducing the barriers to developing 
a bio-weapon. Disease-causing microbes--anthrax is an example--are 
readily available in nature, or they can be acquired from a sick 
person. A skilled biologist, with a laboratory costing no more than 
several hundred thousand dollars, is capable of isolating and 
weaponizing a particularly deadly form of such a microbe. As we said in 
our Report,

``We accept the validity of current intelligence estimates about the 
current rudimentary nature of terrorist capabilities in the area of 
biological weapons but caution that the terrorists are trying to 
upgrade their capabilities and could do so by recruiting skilled 
scientists. In this regard, the biological threat is greater than the 
nuclear; the acquisition of deadly pathogens, and their weaponization 
and dissemination in aerosol form, would entail fewer technical hurdles 
than the theft of production of weapons-grade uranium or plutonium and 
its assembly into an improvised nuclear device.''

    There are other secondary but nevertheless significant reasons why 
bio-weapons might be even more attractive than nuclear weapons to 
terrorist groups. Such weapons are relatively easy to transport without 
detection; they can cause as many or more deaths than a tactical 
nuclear weapon; they can be more easily stockpiled, making it possible 
to hit several targets in succession; and--depending on the biological 
agent used--it is entirely possible that terrorists could launch such 
an attack and escape the area before the authorities even knew that an 
attack had occurred. The symptoms of anthrax (and many other diseases 
capable of being used as bio-weapons), do not manifest for several days 
after exposure and can easily, in the early stages, be mistaken for 
influenza and other naturally-occurring diseases.
    The aim of the terrorists is not just to kill, but to create as 
much fear as possible. As we saw last year during the Ebola outbreak, 
societies are susceptible to panic over even natural epidemics. The 
subcommittee can well imagine the effect in a large city if large 
numbers of people became ill or died because terrorists had weaponized 
a deadly pathogen and spread it through urban neighborhoods or in the 
transportation system. The Department of Homeland Security, Office of 
Science & Technology has modeled the effects of a potential anthrax 
attack on a city like New York; I invite the subcommittee's attention 
to their conclusions.
    So we knew the terrorists had the motivation to get biological 
weapons, and we were quite concerned that advances in life sciences 
would bring development of such weapons increasingly within their 
capabilities. I was particularly influenced by Senator Graham's opinion 
in this regard; as a former Intelligence Committee Chairman, he had and 
has extensive experience with how the terrorists think and plan. Even 
though most of the Commission members were experts primarily in nuclear 
proliferation, they fully agreed to highlight the bio-threat and put 
our recommendations in that regard first in the Report.
    Of course we did not devalue the danger of nuclear proliferation to 
terrorists; it is a real threat, and our Report made a number of 
recommendations for minimizing it.
    After we released ``World at Risk'', the bipartisan Congressional 
leadership extended the life of our Commission and asked us 
specifically to report on the status of our recommendations and, more 
generally, the extent and effectiveness of our Government's efforts to 
prevent and/or prepare a WMD terrorist attack. We issued a second 
Report in January 2010 in the form of a report card. We gave a range of 
grades, some of them quite high; but in the crucial area of 
preparedness to respond to a bio-attack, we gave the Government an 
``F''.
    Preparedness for a biological attack, or for that matter a 
naturally-occurring epidemic, means having a well-developed 
infrastructure which can:
   detect and diagnose a biological event,
   communicate effectively and in real time the nature and 
        spread of disease,
   stockpile and distribute medical countermeasures,
   treat large numbers of afflicted people, and
   (where necessary) remediate the environment in areas that 
        have been exposed.
    During our final meeting, the commissioners encouraged Senator 
Graham and me to continue our work as a not-for-profit organization. 
Along with our executive director at the WMD Commission, Randy Larsen, 
we created the Bipartisan WMD Terrorism Research Center (WMD Center). 
We also brought in Lynne Kidder, who was (and still is) a co-chair of 
the Institute of Medicine's Forum on Medical and Public Health 
Preparedness for Catastrophic Events.
    Senator Graham and I decided that the most helpful project for the 
WMD Center would be a thorough, end-to-end assessment of the country's 
state of preparedness for a major biological event, either natural or 
because of an attack. No government or private organization had ever 
accomplished such an assessment.
    We recruited a distinguished group of 11 senior advisors including: 
The former deputy commissioner of FDA, the director of the American 
Medical Association's Center for Disaster Medicine and Emergency 
Response, a former special assistant to the President for biodefense in 
both the Clinton and Bush (43) administrations, a retired major general 
who had led medical countermeasure development for DoD, the vice 
president and director of RAND Health, and the former chief legal 
advisor to the Centers for Disease Control and Prevention.
    These senior advisors wrote the questions that needed to be 
answered to determine America's preparedness for bio-response. A 
separate consulting team of subject-matter experts then did extensive 
research to answer these questions.
    Senator Graham and I and our staff at the WMD Center used this 
information to assign the grades.
    A copy of the Report Card has been distributed to the subcommittee 
and staff. I invite your attention to our findings. Though I will not 
attempt to detail all of them here, I want to make a general 
observation and then comment on several of the findings which in my 
view are the most important.
    While every effort should be made to prevent a bio-attack, we 
cannot plan on the assumption that those efforts will be successful 
forever. The struggle against terrorism is long-term, and as long as it 
lasts, there is a good chance, for the reasons I've noted, that at 
least some of the terrorist groups will continue to try to acquire and 
deploy a bioweapon. Our first Report noted that they may well be 
successful. The efforts we make now to prepare will be crucial to 
limiting the impact of such an attack; with a swift and effective 
response, the loss of life and collateral effects can be drastically 
reduced.
    Of course any loss of life because of a bio-attack would be tragic. 
But the better hardened we are, the more likely it is that a bio-attack 
will not be a weapon of mass destruction, and the less likely it is 
that the terrorists will choose to use it. In other words, preparedness 
can be a form of prevention. This is a point Senator Graham has often 
made, and rightly so. We may actually be able to deter such an attack 
if it is clear that we are as prepared as possible to respond to it.
    I want to note several specific aspects of the WMD Commission 
Report Card (January, 2010) and the WMD Center Report Card (October, 
2011).
    First and foremost, the lack of sufficient medical countermeasures 
(MCMs) in our Strategic Nation Stockpile (SNS), and the lack of a 
system to quickly develop and produce MCMs during a crisis was our No. 
1 concern in 2011 and remains so today. This is a complex problem with 
many key elements: Basic science (NIH), advanced development (BARDA), 
and regulatory science (FDA). As we said in the WMD Center Report Card, 
``A bio-response enterprise without adequate medical countermeasure is 
like an Army without bullets--it may look good on a parade ground, but 
has minimal value for National security.''
    The recent Ebola virus outbreak highlighted that unless 
countermeasures are immediately available, including diagnostics tests 
that can be used by clinicians who are evaluating suspected cases, 
therapeutics to treat cases and vaccines to protect health care workers 
and others at risk, we are left with fairly primitive means to respond 
to and contain such events.
    The challenge is not unmanageable. The list of bio-threat agents 
for which we should have a diagnostics tests, therapeutics, and 
vaccines for is about a dozen. To date, our stockpile contains 
countermeasures for only 3 or 4. The entity in the U.S. Government 
responsible for developing and producing these countermeasures, the 
Biomedical Advanced Research and Development Authority (BARDA) at the 
Department of Health and Human Services has been chronically 
underfunded. Originally authorized by Congress in 2006 to receive about 
a $1 billion annually, it has received one-quarter to half of that 
amount. As we witnessed with the Ebola outbreak, it is too late to 
develop countermeasures after an outbreak or attack has happened.
    There have been some bright spots and progress. Thanks to the 
efforts of Dr. Luciana Borio at FDA, we have made significant progress 
in regulatory science since 2011, some of which was seen in the Ebola 
response last year when new diagnostics were approved by FDA in a 
matter of days. We have also seen a shift in strategy regarding MCMs in 
a move away from ``one-bug, one-drug'' to a more flexible, rapid 
response. However, as we noted in the WMD Commission Report, if we 
continue to fund BARDA at a fraction of its actual requirements, we 
cannot expect to dig ourselves out of this preparedness hole.
    Second, at the time of our WMD Center Report Card, we had no 
reliable means to dispense the countermeasures quickly. A number of 
cities had experimented with various distribution systems, but the 
process was not National and was not moving quickly enough. This is a 
shortfall I find particularly worrisome; the prospect of what will 
happen if there is an attack, and our people know there are 
countermeasures but can't get access to them. This is an essential, 
underappreciated and under-valued element of a response. We may be 
confronted with a situation where we have countermeasures but can't get 
them to the people who need them, when they need them.
    Third, our Report Card noted that there had been some significant 
progress in improving the public health infrastructure in the various 
States, though our overall evaluation was that the medical system was 
not capable of managing the surge in demand that would be created by a 
major biological event. At the time we issued our Report Card, the 
budgetary stresses of the Federal Government were just beginning to 
take their toll on the public health system, particularly at the State 
and local level. I fear that funding reductions since then have 
undermined such progress as had been made at the time we were writing.
    Finally, there are significant shortfalls in how both the Executive 
and Legislative branches are organized to deal with this issue. Today 
there are more than two dozen Presidentially-Appointed, Senate-
Confirmed individuals with some responsibility for bio-defense, but 
none of them has bio-defense for a full-time job and no one is in 
charge. This virtually guarantees a fragmented response. The 
administration appointed a WMD Coordinator, to oversee the general WMD 
proliferation issue; that was an improvement. But since the departure 
of Elizabeth Sherwood Randall from the NSC to become the deputy 
secretary of Energy, that position has remained vacant. Ideally, there 
should be a special assistant to the President devoted full-time to the 
bio-threat (both man-made and naturally-occurring), as existed during 
the both the Clinton and Bush (43) administrations.
    The Congressional oversight structure is also far too fragmented. 
Again, a number of committees have responsibility for pieces of the 
effort. It's difficult even to determine exactly how many committees 
and subcommittees are involved. Senator Graham and I are both well 
aware of the difficulties inherent in restructuring and unifying 
Congressional oversight. But we also know the vital contribution 
Congress can make in this area, if it is organized in a way that allows 
the full weight of Congressional influence to be brought to bear. It 
would be well worth a major effort by the bipartisan leadership, joined 
by Chairs and Ranking Members, to unify oversight to just a few 
committees with clearly-defined areas of authority.
    A more unified chain of command within Congress and the Executive 
Branch would allow the development of relationships and expertise over 
time, and a more strategic approach by the top-level political 
authorities, that Senator Graham and I believed essential to the 
success of this vital effort.
    A final word. Our Report Card was issued 3\1/2\ years ago. Some of 
our findings may be outdated, though given the problems I have noted 
above, I fear that in most areas our preparedness has declined rather 
than improved. In any case, the questions we developed, and asked, are 
still the right questions for you to ask as you do your vital work in 
this area. That was one of our purposes in doing the Report Card: to 
give decision makers tools for understanding the global state of our 
preparedness to respond to a biological event. I urge the subcommittee 
to continue its emphasis on the urgency of this danger, and to use the 
questions we asked as a starting point for understand what must be 
done.

    Ms. McSally. Thanks, Senator Talent.
    The Chairman now recognizes Dr. Cairns for 5 minutes.

  STATEMENT OF CHARLES B. CAIRNS, M.D., INTERIM DEAN, HEALTH 
   SCIENCES CENTER, UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE

    Dr. Cairns. Thank you very much, Chairman McSally and 
Ranking Member Payne, for this opportunity to provide 
testimony.
    The National Collaborative for Bio-Preparedness and the 
U.S. Critical Illness and Injury Trials Group, both are 
designed to improve the surveillance, the detection, and the 
response to and recovery from biological events. The overall 
goal of these programs is to intervene early enough during the 
bio-event to save lives. There is a National need for timely 
intervention in bio-events in order to save lives.
    As an emergency physician, I know that timely diagnosis and 
clinical intervention save lives. I have been involved in a 
State-wide system of heart-attack care that utilizes emergency 
medical services, including EMTs and paramedics, to rapidly 
diagnose and deliver appropriate treatment. This system has 
been replicated across the country and has been proven to save 
lives.
    Thus, we have shown that we can provide timely, life-saving 
interventions for anyone, anywhere, anytime, on a State-wide 
basis. We need to extend these systems Nationally and apply 
them to biological threats, whether they are due to 
bioterrorism or natural disease outbreaks.
    So the NCBP system was designed to provide rapid 
recognition of clinically significant biological events, with 
the mission to provide more effective decision making in health 
and emergency responses at the Federal, State, and local level.
    Last fall, NCBP released an operational system capable of 
real-time analysis of streaming health data. Users can search 
by clinical symptoms, syndromes, free text within health 
records, and incorporate data on hospital resources, weather, 
critical infrastructure, and internet searches. The NCBP 
architecture can now support the integration of virtually any 
data source for simultaneous analysis and layered geographical 
visualization.
    Now, while the system was originally developed as a tool to 
detect incidents of bioterrorism for use by analysts within the 
Department of Homeland Security National Biosurveillance 
Integration Center, DHS now appreciates the system offers the 
opportunity to collaborate with State and local officials in 
sectors such as public health preparedness, health care, 
infrastructure protection, and agriculture. This collaboration 
provides more sensitive and specific insights than DHS 
attempting to monitor the Nation single-handedly.
    For example, local jurisdictions have a difficult time 
correlating DHS BioWatch environmental measures data to 
clinical data. Local officials are challenged to take action in 
the event of a biological attack without a keen understanding 
of whether people will become ill. The NCBP system is designed 
to provide this important perspective and to support the 
decisions necessary to deploy public health countermeasures.
    I suggest Congress support the efforts of the NBIC program 
to provide NCBP information to local officials.
    EMS data, emergency medical services data, has turned out 
to be most timely and consistent. We have shown that EMS 
records can detect flu outbreaks earlier than the standard 
hospital- and laboratory-based approaches. Indeed, we have 
shown that free text analysis of EMS records can readily 
identify patients at risk for emerging infections. If Texas had 
been part of the NCBP system, it likely would have rapidly 
detected that initial case of Ebola in Dallas last September.
    With adequate funding, NCBP will incorporate additional 
States, implement additional analytic and visualization tools 
and other data types, as well as engage new local, State, and 
Federal users.
    But there is also a National need for a rapid, effective 
clinical response system in bio-events. During public health 
emergencies, reliable patient data are needed to identify 
groups at high risk for severe illness and death and to assess 
the impact of the event on critical health care resources. Yet 
experience with influenza and Ebola indicate that real-time 
clinical data aggregation, analysis, and reporting remain a 
strategic vulnerability.
    Many of these logical challenges stem from the distributed, 
even silent, approach we have to emergency preparedness, as 
delineated by Senator Talent. The good example is, yet again, 
our response to Ebola. There was no preparedness on how to 
collect data longitudinally as to whether the medical 
conditions of the patients presenting were similar, whether 
medical countermeasures worked, or if any of those measures had 
any toxicity or interacted with other therapies, or even if 
they had any effect on long-term outcomes.
    The U.S. Critical Illness and Injury Trials Group Program 
on Emergency Preparedness, which has been supported by ASPR, 
has been partnering with DHS and HHS agencies to begin to 
foster collaboration and build new capacities for data 
collection and research in order to address key questions of a 
successful response and address these challenges to the chain 
of resiliency. Failure to aggressively extend, support, and 
fund this initiative will amount to yet another potential 
failure of imagination for the next outbreak or act of 
bioterrorism.
    Thank you again for the opportunity to testify today, Madam 
Chairman.
    [The statement of Dr. Cairns follows:]
                Prepared Statement of Charles B. Cairns
                             April 22, 2015
                              introduction
    Chairman McSally and Ranking Member Payne, my name is Dr. Charles 
Cairns and it is an honor to be providing this testimony. I currently 
serve as the interim dean of the College of Medicine, professor of 
Emergency Medicine, and vice president of clinical research of the 
University of Arizona.
    Prior to Arizona, I served as the chair of the Department of 
Emergency Medicine at the University of North Carolina and as director 
of Emergency Research at the Duke Clinical Research Institute of Duke 
University.
    I have served as the principal investigator of the National 
Collaborative for Bio-preparedness and as the director of the United 
States Critical Illness and Injury Trials Group.
    In both of these programs, the Government has invested in improving 
its surveillance and detection capability in support of, and enabling 
of more efficient response to and recovery from biological events. The 
overall goal is to intervene early enough during a bio-event to save 
lives.
                   national need: timely intervention
    As an emergency physician, I know that timely diagnosis and 
clinical intervention can save lives--both for individual patients and 
across populations and geographies. I have been involved in the 
development and implementation of a State-wide system of heart attack 
care that has resulted in having a rapidly diagnosis and treatment plan 
for every emergency medical services agency in every county of North 
Carolina every day. The system integrates the State-wide 9-1-1 system 
with pre-hospital technology to diagnose heart attacks with destination 
plans to deliver heart attack patients directly to the right health 
care resource or hospital (Mears, et al, Curr Opin Crit Care 2009). The 
result of this system has been to have a plan to rapidly diagnose every 
heart attack in the State and rapidly deliver life-saving care. This 
system has been shown to save lives (Glickman, et al, Ann Emerg Med 
2012) and has been replicated across the country.
    Thus, we have proven that we can effectively develop and implement 
systems that can provide timely, life-saving interventions for anyone, 
anywhere, anytime (Cairns, et al, Ann Emerg Med 2012) and to extend 
these systems to biological threats.
              national collaborative for bio-preparedness
    The National Collaborative for Bio-Preparedness (NCBP) is a system 
designed to provide rapid recognition of clinically significant 
biological events, whether they are due to disease outbreaks, 
contaminations or poisonings due to either natural causes or terrorism. 
(Arasaratnam M, et al. Online J Public Health Inform, 2013). NCBP 
utilizes a web-based system (https://ncbp.bioprep.us/) of near real-
time data collection, automated assessment and analysis to detect 
relevant disease conditions and symptoms. The system is designed to 
meet the bio-surveillance needs of key local and regional stakeholders 
while providing awareness and transparency of events to State and 
National decision makers. In addition, the NCBP system is providing 
information on critical health care infrastructure and relevant 
interventional needs and care resources. Thus, rapid recognition of 
events can be matched to the necessary resources on a timely and 
geographically relevant basis, providing a context of when local or 
State resources are insufficient to match the needs of the affected 
population.
    The NCBP is a project sponsored by the U.S. Department of Homeland 
Security (DHS) through a cooperative agreement with the University of 
North Carolina at Chapel Hill (UNC). Begun in 2010, the NCBP mission is 
to:

``Enable its users to recognize events occurring in the biosphere that 
have significance to the health and security of people and 
infrastructure in users' jurisdictions, leading to more effective 
decision making in health and emergency response at the Federal, State 
and Local level.''

    On September 15, 2014, NCBP released an operational data 
visualization and analytics system capable of real-time analysis of 
streaming health data to detect meaningful changes in the data and 
visualizing the information in a geographic format. The system also 
enables users to search records by clinical symptoms, user-defined 
syndromes, and free text within the health records. The system has been 
developed using human health data from Emergency Medical Services 
(EMS), 
9-1-1, Emergency Department (ED) and Poison Control Centers, with 
incorporation of State-wide hospital bed and resource availability, 
live weather data, critical infrastructure (schools, roads, hospitals, 
Federal facilities) and internet search feeds (Google searches). NCBP 
architecture can now support the integration of virtually any data 
source for simultaneous analysis and layered visualization to provide 
greater insight and fidelity for the Nation's preparedness resources 
and decision makers.
    NCBP is unique in offering near real-time clinical data and custom 
analytics that generate signals and communicate them to users as the 
analysis occurs, with the goal of providing warnings of significant 
anomalies, in time to inform decision makers and support a response. 
The system is available to users 24/7/365.
    The system was originally developed for analysts within DHS' 
National Biosurveillance Integration Center (NBIC), the project's 
sponsor, as a tool to detect incidences of bioterrorism. However, DHS 
appreciates that the system offers the opportunity to collaborate with 
State and local officials in the sectors of public health preparedness, 
human health, infrastructure protection, and agriculture. This 
collaboration provides more sensitive and specific insights, and thus a 
higher level of security for the Nation, than DHS attempting to monitor 
the Nation singlehandedly. NCBP is therefore offering the system to 
State and local officials and infrastructure owners who can contribute 
to the system's development and design.
    For example, DHS has operated the Nation's environmental detection 
system for bioterror events, known as BioWatch. To date, local BioWatch 
jurisdictions have a difficult time correlating these environmental 
measurements to clinical data. In other words, local officials are not 
in the position to take action with public health countermeasures 
needed in the event of biological attack without a keen understanding 
of whether people and animals are becoming ill or are likely to become 
ill. The NCBP system and the US Critical Illness and Injury Trials 
(USCIIT) Group are designed to provide this important perspective and 
to support the decisions necessary to deploy public health 
countermeasures. Local jurisdictions have long recognized this need for 
clinical context to the BioWatch signals and I suggest Congress support 
the efforts of the DHS NBIC program to provide NCBP information to 
them. Local officials are the ones making the decision to deploy public 
health countermeasures and thus, Federal agencies should be providing 
local officials the information needed for effective decision support.
    Among various sources of human health data, data from Emergency 
Medical Services (EMS) has turned out to be the most timely and 
consistent. These near real-time data are entered by trained providers 
utilizing standardized forms and our group has pioneered the 
development of these systems, especially for EMS (Mears, et al, Prehosp 
Emerg Care 2010). EMS data is population-based and is gathered by local 
EMS professionals who record emergency health data in free text, and 
they transmit it daily to the NCBP data center partner. NCBP currently 
incorporates every EMS call in NC, SC, and (soon) WV, MS, IN, and AZ 
into its analysis, most within 24 hours. EMS data are acquired in a 
Nationally-standardized format National EMS Information System 
(NEMSIS), containing patient complaints, provider assessment, time 
stamps, and the geocoding that enables geospatial analysis. As a result 
of this standardization, EMS data will be the most expedient source for 
NCBP to expand rapidly to other States.
    In 2015, NCBP is entering the phase of development for expansion of 
the system toward a Nation-wide network of biosurveillance users, in 
order to provide ultimate value to the Federal Government, and enables 
a wide network of State and local users to contribute to the Nation's 
biopreparedness. With adequate funding, NCBP will incorporate 
additional States, implement additional analytic and visualization 
tools, add other data types (such as animal health and agricultural 
data) and engage new users from those disciplines. The goal for NCBP is 
to transition the system into a self-sustaining, not-for-profit entity 
to provide service to the Federal Government.
       national need: a rapid, effective clinical response system
    The appropriate treatment of critically ill or injured patients can 
vary minute-to-minute. Thus, timely access to reliable data is one of 
the foundations of contemporary intensive care. It follows then that 
optimal responses during public health emergencies, for both clinicians 
and decision makers, would benefit from comprehensive, real-time event 
reporting. This should include physiological patient data that are 
needed to provide immediate insight into the impact of the event on 
critical health care resources and to identify groups with high risk 
for morbidity and mortality.
    Importantly, this reporting should include the highly granular 
patient data that is needed to: (1) Characterize clinical features, (2) 
provide immediate insight into the impact of the event on critical 
health care resources (e.g., mechanical ventilation, dialysis, 
medication availability), (3) assess health care staffing availability 
and training/educational needs, (4) identify groups of patients with 
high risk for morbidity and mortality, and (5) determine the efficacy 
and safety of treatment and medical countermeasures. Recent experiences 
globally, however, indicate that real-time clinical data aggregation, 
analysis, and reporting remain a strategic vulnerability during public 
health emergencies. (Lurie, et al. N Engl J Med 2013).
    The United States Critical Illness and Injury Trials Group (http://
www.usciitg.org) through its Program for Emergency Preparedness 
(USCIITG-PREP) aims to significantly enhance the National capability to 
rapidly glean crucial information regarding the clinical course of 
acute illness and injury and guide clinical resource requirements 
during emergent events:
   Real-time collection of clinical data by a coordinating 
        center during a regional or National public health emergency;
   Rapid analysis of clinical data to address key analytic 
        outcomes, answering both clinical and operational questions:
     What was the nature of the clinical insult and the 
            resulting phenotype?
     As a clinical responder, what, if anything, did you have 
            to do differently?
     Did clinical diagnostics, countermeasures, and therapies 
            work as expected?
     What was the operational impact on the patient and care 
            setting?
     Was there anything essential needed that you did not get?
     What is the best/worst case that could happen next time?
   Timely dissemination of event-related information to inform 
        front-line treatment of disease and resource allocation, 
        assuring patient confidentiality, data security, and strict 
        version control.
    Working with the Office of the Assistant Secretary for Preparedness 
and Response (HHS/ASPR), leading professional organizations, and the 
Homeland Security Information Network (HSIN), USCIITG-PREP has been 
developing mechanisms for rapid clinical data collection, analysis, and 
dissemination of findings during public health emergencies. Pre-event 
work on protocols, data collection processes, rapid analysis 
techniques, and means to quickly disseminate findings to stakeholders 
are all crucial to making clinical science networks effective at 
enhancing the response. The USCIIT Group will leverage existing 
infrastructure to both strengthen pre-event operational science 
capabilities and provide timely data and situational awareness across 
the emergency care continuum during public health emergencies. Critical 
illness and injury professional organizations will use this rapid 
dissemination plan to inform their membership, in aggregate 
representing over 150,000 front-line clinicians, thereby saving lives 
and minimizing suffering based on the timely accurate guidance gleaned 
from operational science.
    Furthermore, optimal outcomes in response to public health 
emergencies require rapid feedback on how well medical countermeasures 
(MCM) work to protect and treat affected individuals and their 
families. This information is used by clinicians in the field to guide 
therapy and by public health agencies responsible for mobilizing the 
necessary resources at both the regional and National levels. The 
overarching goal of USCIITG-PREP is to facilitate development of MCM's 
to protect against threats, specifically, select public health 
emergencies. USCIITG-PREP is working to develop and implement 
strategies to assess, evaluate, and monitor medical countermeasure 
safety, performance, and patient compliance in response to a public 
health emergency. The communication systems, infrastructure, data 
analysis and reporting algorithms, and sample collection and processing 
protocols that USCIITG-PREP develops for seasonal influenza could be 
applied directly to protect against other threat agents, including 
pandemic influenza (such as 2009 pH1N1), emerging respiratory viruses 
(such as H7N9, MERS-CoV, Ebola), and other biothreats agents such as 
inhalational anthrax. This work is also important because USCIITG-PREP 
uniquely catalyzes communication and builds infrastructure across the 
care continuum (prehospital, emergency department, intensive care 
units, rehab, adult and pediatric), linking HHS agencies, academic 
medical centers, community medical centers, critical illness and injury 
professional organizations, and industry. The USCIITG-PREP Steering 
Committee includes representatives from FDA, NIH, CDC, ASPR, and BARDA.
         united states critical illness and injury trials group
    The United States Critical Illness and Injury Trials (USCIIT) Group 
serves as a ``network of networks'', with the dual missions to foster 
investigator-initiated hypothesis testing and to develop 
recommendations for strategic plans at a national level. (Cobb JP, et 
al. J Trauma 2009; Blum, et al. Chest 2013). To these ends, the USCIIT 
Group provides a venue for investigator communications, supports a 
multi-society task force for research strategic planning, catalyzes HHS 
inter-agency dialog for endorsement of transforming initiatives (e.g., 
NIH-ASPR-FDA-CDC-BARDA), and fosters innovative, multidisciplinary, 
multicenter studies the results of which will improve clinical care and 
preparedness (Cobb, Crit Care Med 2009; Deutschman CS, Crit Care Med 
2012). The USCIIT Group is endorsed by all major U.S. critical illness 
and injury professional organizations spanning the specialties of 
anesthesiology, emergency medicine, internal medicine, nursing, 
pediatrics, pharmacy and nutrition, surgery and trauma, and respiratory 
and physical therapy. The USCIIT Group has grown to include over 200 
investigators across more than 30 academic and community hospitals. 
Collectively, USCIIT Group investigators have enrolled over 10,000 
patients in studies during the last four years. For more details, 
please visit the USCIIT Group web page at www.usciitg.org.
    The USCIIT Group organizes some of its investigator-initiated 
projects (now numbering more than 50) into several, large-scale, 
collaborative programs, consistent with the recent consensus strategic 
plan for critical illness and injury research in the United States.
   Program for Prevention of Organ Failures (USCIITG-PROOF).--
        Efforts to prevent organ failure are hampered by three 
        barriers: (i) Compartmentalization of care (emergency 
        department, operating room, ICU, etc.), (ii) the difficulty of 
        identifying early those at risk, and (iii) lack of proven, 
        effective preventative interventions. Building on the success 
        of the Lung Injury Prevention Study (USCIITG-LIPS),\1\ the 
        unique, multidisciplinary, USCIIT Group network, and CTSA-
        funded infrastructure, USCIITG-PROOF addresses all three 
        barriers simultaneously through rapid cycle, multicenter 
        clinical trials that span clinical domains to test a variety of 
        interventions that prevent organ failure in those at risk.
---------------------------------------------------------------------------
    \1\ Mears GD, Pratt D, Glickman SW, Brice JH, Glickman LT, Cabanas 
JG, and Cairns CB. The North Carolina EMS Data System: a comprehensive 
integrated emergency medical services quality improvement program. 
Prehosp Emerg Care, 14, 85-94. 2010.
---------------------------------------------------------------------------
   Program for Critical Illness Outcomes (USCIITG-CIOS).--Care 
        delivered in intensive care units is high-intensity, high-cost, 
        and has tremendous geographic and organ-specific variation. 
        Little is known about which ICU organizational and structural 
        factors are associated with high-quality care and optimized 
        outcomes. To determine which of these factors are most strongly 
        associated with high-quality critical care, USCIITG-CIOS 
        enrolled 66,400 patients across 69 ICU's in the United 
        States.\2\ CIOS-2 planning is underway with grant submissions 
        planned for this calendar year. There are numerous new 
        collaborative opportunities for ancillary studies for those 
        interested (we're especially interested in supporting new 
        investigators).
---------------------------------------------------------------------------
    \2\ Blum JE, Morris PE, Martin GS, Gong MN, Bhagwanjee S, Cairns 
CB, Cobb JP: U.S. Critical Illness and Injury Trials Group. Chest. 2013 
Mar 1;143(3):808-13.
---------------------------------------------------------------------------
   Program for Early ICU Rehabilitation (USCIITG-PEIR) and 
        USCIITG-Burn.--Physical therapists, respiratory therapists, 
        speech language pathologists, and occupational therapists are 
        essential for coordinating rehabilitation of critically ill or 
        injured patients. Early rehabilitation can help to ameliorate 
        and even avoid severe deconditioning associated with post-ICU 
        syndrome (PICS), which presents as long-term physical, 
        cognitive, and mental health problems after severe critical 
        illness or injury. USCIITG-PEIR seeks to identify areas of 
        heterogeneity of care and to improve early rehabilitation for 
        critically-ill or injured patients. Funded by the DOD, USCIITG-
        PEIR collaborates with USCIITG-Burn to actively enroll patients 
        in a multi-center, randomized controlled clinical trial to 
        measure the effect of early rehabilitation on hospital stay, 
        muscle loss, and functional outcomes in burn patients with 
        acute respiratory failure.
   Program for Emergency Preparedness (USCIITG-PREP).--There 
        are insufficient capabilities internal to HHS to rapidly 
        collect clinical data to inform decision makers and key end-
        users in public health emergencies, especially on illness 
        severity and physiology. The USCIITG-PREP Group was funded by 
        the Office of the Assistant Secretary for Preparedness and 
        Response (ASPR/HHS) to create an electronic Core Data Set for 
        public health emergencies.\3\ Version 1 of the data set was 
        tested and validated across 12 clinical sites (HHS contract, 
        Rapid Assessment of Acute Illness and Injury to Enhance the 
        U.S. Response to Public Health Emergencies) with data analysis 
        and dissemination within 24 hours of data collection. USCIITG-
        PREP is seeking support to operationalize data set capabilities 
        at the National level, including IRB innovations to insure 
        patient safety and protect privacy during emergent events as 
        well as data analysis and rapid dissemination plans.
---------------------------------------------------------------------------
    \3\ Laurie N, Manolio T, Patterson AP, Collins F, Frieden T. 
Research as a part of public health emergency response. N Engl J Med. 
2013 Mar 28;368(13):1251-54.
---------------------------------------------------------------------------
   USCIITG-PREP PULSE Project.--USCIITG-PREP has been supported 
        by ASPR to convene internet forums to address preparedness and 
        response for threats to public health. The goal is to get near 
        real-time feedback from USCIITG critical care volunteers 
        distributed across the United States. For example, some parts 
        of the country are experiencing a shortage of normal saline and 
        others a resurgence of severe respiratory failure from H1N1; 
        other regions are not. This new tool is designed for USCIITG-
        PREP to document this variance in experience and assess health 
        system stress. For USCIITG-PREP and ASPR to keeps its fingers 
        on the ``pulse'' of a potential threat, feedback from our 
        investigators in the form of answers to a few questions, say 
        weekly, would be extremely helpful. Thus, we've called this 
        internet-based tool ``USCIITG-PREP Pulse'', or simply Pulse, 
        for short. After a successful pilot project on saline 
        shortages, we are compiling a list of additional investigators/
        members who are interested in participating in Pulse. The 
        project is sensitive to investigator time with the expected 
        response burden for each forum will be minimal (less than 10 
        questions). We also expect that use of the tool will quickly 
        evolve, making the response network more efficient and robust, 
        and the Pulse tool easier and easier to use.
   USCIITG-PREP Medical Countermeasures Project.--Optimal 
        outcomes in response to public health emergencies require rapid 
        feedback on how well MCM's work to protect and/or treat 
        affected individuals and their families. This information is 
        used by clinicians in the field to guide therapy and by public 
        health agencies responsible for mobilizing the necessary 
        resources at both the regional and National levels. The 
        overarching goal of USCIITG-PREP is to facilitate development 
        of MCM's to protect against threats, specifically, select 
        public health emergencies. The overarching goal of this FDA 
        proposal is to develop and implement strategies to assess, 
        evaluate, and monitor medical countermeasure safety, 
        performance, and patient compliance in response to a public 
        health emergency. Influenza was chosen as the prototypic test 
        case for this FDA proposal as it is one of the most predictable 
        and serious public health threats. Moreover, the communication 
        systems, infrastructure, data analysis and reporting 
        algorithms, and sample collection and processing protocols that 
        USCIITG-PREP develops for seasonal influenza could be applied 
        directly to protect against other threat agents, including 
        pandemic influenza (such as 2009 pH1N1), emerging respiratory 
        viruses (such as H7N9 or MERS-CoV, Ebola), and other biothreats 
        agents such as inhalational anthrax. This work is also 
        important because USCIITG-PREP uniquely catalyzes communication 
        and builds infrastructure across the care continuum 
        (prehospital to rehab, adult and pediatric), linking HHS 
        agencies, academic medical centers, community medical centers, 
        critical illness and injury professional organizations, and 
        industry. The USCIITG-PREP Steering Committee includes 
        representatives from FDA, NIH, CDC, ASPR, and BARDA.
              national need: cooperation and collaboration
    None of these initiatives will be successful ultimately, without 
the full cooperation and collaboration across Federal agencies, the 
States, and local governments. However, the current climate is not 
necessarily one of collaboration and cooperation. The reasons for this 
are multi-factorial and probably rooted in interagency claims of 
primacy and in segregated budget lines and Congressional oversight. The 
Nation's biodefense effort requires high-level direction and 
coordination from The White House. In past years, the various 
initiatives and programs of the Nation's biodefense apparatus were 
overseen and coordinated directly by The White House, through a Special 
Assistant to the President for Biodefense. This position was vacated in 
2009 and has not been filled. I would urge the Congress to unify its 
oversight of these biodefense programs so that money is spent more 
wisely and the agencies are working on behalf of each other rather than 
in competition.
    This lack of programmatic unity is most felt at the State and local 
level, which is the tip of the spear for the Nation's biodefense. It 
will be the hospital systems and EMS agencies that will first detect 
abnormalities in illness patterns. These same health care institutions 
will be expected to deliver life-saving care in real time, currently 
without the perspective of what resources will need to be available and 
consumed during such an event. Local emergency managers will need to 
execute their contingency plans well before any Federal disaster is 
declared or FEMA shows up.
                               conclusion
    The programs I have described above are important examples of 
programs that capitalize on local health and safety officials and 
practitioners' information and awareness to inform the Federal 
agencies. I encourage Congress to ensure that any biodefense program 
take into account the capabilities and the responsibilities of local 
and State institutions, which must be weaved into the fabric of 
National preparedness.
    Thank you for the opportunity to testify before the subcommittee 
today.
                               References
    Mears G, Glickman SW, Moore F, Cairns CB: Data based integration of 
critical illness and injury patient care from EMS to emergency 
department to intensive care unit. Curr Opin Crit Care 2009 
Aug;15(4):284-9.
    Glickman SW, Greiner MA, Lin L, Curtis LH, Cairns CB, Granger CB, 
Peterson ED: Assessment of Temporal Trends in Mortality With 
Implementation of a Statewide ST-Segment Elevation Myocardial 
Infarction (STEMI) Regionalization Program. Ann Emerg Med. 2012 
Apr;59(4):243-252.
    Cairns CB, Glickman SW: Time Makes a Difference to Everyone, 
Everywhere: The Need for Effective Regionalization of Emergency and 
Critical Care. Ann Emerg Med. 2012 Nov;60(5):638-40.
    Arasaratnam M, Potenziani D, Hoit M, Jenkins C, and Cairns CB. 
National Collaborative on Biopreparedness. Online J Public Health 
Inform, 5, e198. 2013.
    Cobb JP, Cairns CB, Bulger E, et al. The United States critical 
illness and injury trials group: an introduction. J Trauma 2009;67(2 
Suppl):S159-160.
    Cobb JP, Ognibene FP, Ingbar DH, et al. Forging a critical 
alliance: Addressing the research needs of the United States critical 
illness and injury community. Critical Care Medicine 2009;37(12):3158-
3160.
    Deutschman CS, Ahrens T, Cairns CB, et al. Multisociety Task Force 
for Critical Care Research: key issues and recommendations. Critical 
Care Medicine 2012;40(1):254-260.

    Ms. McSally. Thank you, Dr. Cairns.
    The Chairman now recognizes Ms. Raphael for 5 minutes.

  STATEMENT OF MARISA RAPHAEL, DEPUTY COMMISSIONER, OFFICE OF 
 EMERGENCY PLANNING AND RESPONSE, NEW YORK CITY DEPARTMENT OF 
                   HEALTH AND MENTAL HYGIENE

    Ms. Raphael. Good morning, Chairman McSally, Ranking Member 
Payne, and Members of the subcommittee. On behalf of Mayor Bill 
de Blasio and Health Commissioner Mary Bassett, thank you for 
the opportunity to testify on New York City's efforts to 
prepare for and respond to public health emergencies.
    I am here today to discuss the vital role that public 
health plays in detecting and responding to emergencies, the 
importance of Federal public health and health care 
preparedness funding, and examples of how these investments 
have increased preparedness.
    Our Nation's public health and health care infrastructure 
play a critical role in protecting our citizens by quickly 
detecting acts of bioterrorism or naturally-occurring 
outbreaks, containing the spread of disease, and mitigating the 
health impacts of emergencies.
    The department currently receives Federal emergency 
preparedness funding from the CDC Public Health Emergency 
Preparedness program, the ASPR Hospital Preparedness Program, 
and the Department of Homeland Security Urban Areas Security 
Initiative. As a result, the department's public health and 
health care emergency response capabilities have been expanded, 
and we have made vital investments in planned development, 
training and exercises, and skilled and experienced personnel. 
I want to thank the committee and subcommittee for their 
continued recognition of the need for these critical Federal 
programs.
    As the largest point of entry in the United States, New 
York City recognizes the increased likelihood that a naturally-
occurring disease in any area of the world can quickly spread 
to New York City.
    In July 2014, New York City began a highly coordinated and 
expensive multi-agency and multi-jurisdictional response to 
Ebola. To prepare, we addressed hospital readiness, risk 
communication, increased lab capacity, and community 
engagement. We began developing detailed plans for disease 
surveillance and managing a person under investigation, and our 
public health surveillance staff investigated hundreds of 
suspect cases. The public health lab quickly became proficient 
in testing for and rapidly diagnosing Ebola in record time.
    The city chose to focus on readying Bellevue Hospital as 
New York City's primary Ebola treatment center. Bellevue's 
quarantine and isolation unit had been supported over the past 
decade through HPP funding, and, therefore, we could focus on 
enhancing existing capabilities. When the first confirmed Ebola 
case in New York City was identified, we were in a strong 
position to respond.
    One of the biggest challenges we currently face is 
maintaining a permanent state of readiness among city agencies 
in the health care system. This brings us back to the original 
impetus for the Federal preparedness funds: September 11 and 
the subsequent anthrax attacks.
    The receipt of letters tainted with anthrax in 2001 led to 
a State and local requirement to develop mass prophylactic 
capabilities. The primary method of rapidly dispensing 
medication in response to a wide-spread aerosolized anthrax 
attack is through points of dispensing, or PODs, which are 
temporary emergency sites established to provide free 
medication to large numbers of people.
    Years of planning, training, and exercises culminated in 
August 2014, when the department conducted the largest no-
notice exercise on record, the Rapid Activation for Mass 
Prophylaxis Exercise, or RAMPEx. This exercise involved 
notifying and mobilizing over 1,500 city employees and setting 
up and opening 30 PODs simultaneously.
    RAMPEx tested all components of our mass prophylaxis 
response and definitively demonstrated our ability to rapidly 
open 30 PODs city-wide in less than 8 hours, with some ready 
within 6 hours.
    RAMPEx also helped identify critical planning gaps and 
solutions. First, all PODs are ready to open 4 hours before 
medication from CDC's Strategic National Stockpile would 
arrive. To address this gap, the department has requested that 
SNS assets be forward-deployed to New York City and other high-
threat, high-density urban areas that have demonstrated an 
ability to stand up PODs faster than SNS medications can be 
delivered.
    Second, we have not met our POD staffing goals. City-wide 
prophylaxis distribution requires 33,000 POD staff to support 
48 hours of dispensing operations. New York City has made great 
efforts to recruit, pretrain, and assign staff to a POD site 
close to home. We are advocating for non-mission-critical 
Federal staff who live locally to be similarly identified and 
trained to support POD operations.
    Our successful Ebola response and medical countermeasure 
exercise are a direct result of a decade of Federal investments 
in local preparedness. However, the greatest danger to our 
progress is the decline in Federal funding. While overall 
preparedness funding should be increased, allocations should 
also be based on risk to reflect the scale-of-threat impact to 
high-density urban areas and complexity of response.
    The department relies on dedicated Federal funding streams 
to build and maintain critical public health and health care 
capabilities. Significant cuts in funding jeopardize our 
existing capabilities. PHEP funding for New York City has 
decreased 35 percent from its peak in fiscal year 2005, which 
has led to a 47 percent reduction in the public health 
preparedness workforce, compromising our ability to detect and 
respond to disease outbreaks.
    I am reading as fast as I can, but I may run a little over.
    Similarly, drastic cuts of nearly 40 percent to HPP have 
impeded health care-sector preparedness and response efforts. 
There are 55 hospitals, 259 long-term-care facilities, 303 
primary care centers, 50 urgent care centers, and 101 dialysis 
centers in New York City. Preparing a health care system of 
this size and complexity requires significant resources.
    In the immediate months following a particular emergency, 
jurisdictions have occasionally received one-time funding. New 
York City is thankful to have received funds to address our 
Ebola response. However, singular funding allocations are not 
an adequate substitute for sufficient and sustained base 
funding.
    There is also a critical need for a real-time funding 
mechanism to support public health emergency response, not just 
preparedness efforts. Currently, we must use Federal 
preparedness funds to cover response costs. Federal budgets 
designed to support public health and health care system 
preparedness and response capabilities must be increased and 
sustained.
    Chairman McSally and Ranking Member Payne, thank you for 
inviting me to testify today. We are grateful for your 
continued support, and I look forward to your questions.
    [The prepared statement of Ms. Raphael follows:]
                  Prepared Statement of Marisa Raphael
                             April 22, 2015
    Good morning Chairman McSally, Ranking Member Payne, and Members of 
the subcommittee. I am Marisa Raphael, deputy commissioner for the 
Office of Emergency Preparedness and Response at the New York City 
Department of Health and Mental Hygiene. Our mission is to promote New 
York City's ability to prevent, prepare for, respond to, and recover 
from public health emergencies. I have been privileged to serve in a 
leadership role in this field for more than a decade. On behalf of 
Mayor Bill de Blasio and Health Commissioner Mary Bassett, thank you 
for the opportunity to testify on New York City's efforts to prepare 
for and respond to emergencies with public health and medical 
consequences.
                public health and emergency preparedness
    I am here today to discuss the vital role that public health plays 
in detecting and responding to emergencies, the importance of Federal 
public health and health care preparedness funding, and examples of how 
these investments have increased preparedness. I will focus on our most 
recent and on-going Ebola response and the Rapid Activation and 
Mobilization Point of Dispensing Exercise, called RAMPEx, which the 
Health Department conducted in August 2014.
    Our Nation's public health and health care infrastructure play a 
critical role in protecting our citizens by quickly detecting acts of 
bioterrorism or naturally-occurring outbreaks, containing the spread of 
disease, and otherwise mitigating the public health impacts of 
emergencies. State and local health departments along with their local 
health care systems play equally vital roles as that of first responder 
agencies--we prevent illness and save lives. The Department currently 
receives Federal emergency preparedness funding from the Centers for 
Disease Control and Prevention (CDC) Public Health Emergency 
Preparedness program (PHEP), the Assistant Secretary for Preparedness 
and Response (ASPR) Hospital Preparedness Program (HPP) cooperative 
agreements, and the Department of Homeland Security Urban Area Security 
Initiative (UASI) grant awards. As a result, the Department's public 
health and health care emergency response capabilities have been 
expanded, and we have made vital investments in plan development, 
training and exercises, supplies and equipment, and skilled and 
experienced personnel to respond to a broad range of emergencies. In 
New York City, a perpetual target for terrorism, focal point for 
disease outbreaks, and victim of natural disasters, these investments 
have been critical to shoring up our public health and health care 
system. I want to thank the committee and subcommittee for their 
continued interest and recognition of the need for these critical 
Federal programs.
                         ebola in new york city
    As the largest point of entry in the United States, we recognize 
the increased likelihood that a naturally-occurring disease in any area 
of the world can quickly spread to New York City. This was demonstrated 
during our recent and on-going response to Ebola. Beginning in July 
2014, when it became apparent that cases of Ebola were increasing in 
West Africa and that an individual with Ebola would likely reach New 
York City, the city activated a highly-detailed, coordinated, and 
expensive multi-agency and multi-jurisdictional effort. The Mayor 
convened interagency preparedness meetings to discuss various scenarios 
and ensure our health care system and first responders were aware of 
their roles and familiar with protocols. I would be remiss to not 
mention the over 20 agencies, including the NYC Health and Hospitals 
Corporation (HHC), FDNY, NYPD, and NYC Office of Emergency Management 
that worked hand-in-hand with our team at Health and City Hall to 
ensure a coordinated response. Each city agency dispensed invaluable 
expertise and leadership and I cannot emphasize enough how critical 
coordination is in the face of threats like this.
    To give you a sense of our preparation at the Health Department, we 
addressed hospital readiness, risk communication and emergency 
transport, increased lab capacity, and community engagement. The Health 
Department began developing detailed plans for disease surveillance, 
emphasizing early detection, isolation and rapid notification, as well 
as plans to manage a person under investigation. Our public health 
surveillance and epidemiology staff investigated hundreds of suspect 
cases; the Public Health Laboratory quickly became proficient in 
testing for Ebola to facilitate rapid diagnosis and delivered test 
results in record time. We also prioritized community engagement, 
distributing over 100,000 ``Am I at Risk?'' palm cards and speaking at 
over 115 public events to address the public health concerns of New 
York City's diverse communities. For example, our Commissioner 
personally went out into West African immigrant communities and other 
vulnerable areas of the city to begin a dialogue about, not only of the 
risks of infection, but also discussing issues of tolerance to ensure 
immigrants were being treated fairly.
    Most notably, HHC proactively conducted extensive staff training at 
each of its 11 hospitals, to be prepared to receive and screen 
individuals potentially exposed to the disease. Additionally, the city 
chose to focus on readying Bellevue Hospital as the primary NYC Ebola 
treatment center. Bellevue was selected because its ``quarantine and 
isolation'' unit has been supported over the past decade through HPP 
funding and we could focus on enhancing existing capabilities by 
further training staff and hiring additional personnel, as well as 
outfitting of isolation rooms to properly handle additional electrical 
and laboratory capacity. The fact that Bellevue was the sole facility 
ready to receive and treat an Ebola patient when that capacity was 
actually needed--and that it did so with successful outcome for the 
patient and all the personnel who care for and supported the patient--
is merely part of the remarkable preparedness and response work 
overseen by Dr. Raju, HHC's president.
    Years of planning made possible through the previously-mentioned 
funding gave the city the capacity to quickly prepare and respond to 
the Ebola threat. On October 23, 2014, when the first confirmed case in 
New York City was identified the city was in a strong position to 
respond because of these Federal dollars. Nonetheless, funding is still 
needed to reimburse the city for the costs incurred in transporting, 
screening, treating, and monitoring persons with or potentially exposed 
to Ebola.
                 mass prophylaxis capability and rampex
    One of the biggest challenges we currently face is maintaining a 
permanent state of readiness among city agencies and the health care 
system. This brings us back to the original impetus for the Federal 
preparedness funds--the September 11 attacks and the subsequent anthrax 
attacks.
    The receipt of letters tainted with anthrax in multiple cities in 
2001 led to a State and local requirement to develop mass prophylaxis 
capabilities. PHEP funds support State and local health departments to 
develop and execute plans for the mass dispensing of medication in 
response to a biological attack. In the case of a wide-spread, 
aerosolized attack, all potentially exposed people must begin taking 
antibiotics within 48 hours to prevent illness and death. While 48 
hours is the target, modeling has shown that the more rapidly 
medication is provided to the public, the more lives will be saved. The 
primary method of rapidly dispensing medication is through Points of 
Dispensing, or PODs, which are temporary emergency sites established to 
provide free medication to large numbers of people to prevent them from 
becoming sick. Years of planning, training, and exercises as well as 
our investment in a team of experienced, highly-skilled Health 
Department emergency managers culminated on August 1, 2014, when the 
Health Department conducted the largest no-notice emergency response 
exercise on record: The Rapid Activation for Mass Prophylaxis Exercise, 
or RAMPEx. This exercise involved notifying and mobilizing over 1,500 
city employees and setting up and opening 30 PODs simultaneously, and 
was funded by UASI.
    RAMPEx tested all components of our mass prophylaxis response to an 
aerosolized anthrax attack from the mobilization of our Receipt, Stage, 
and Store (RSS) warehouse, to the coordination of our command and 
control center and mobilization of PODs. RAMPEx definitively 
demonstrated our ability to rapidly open 30 PODs city-wide in less than 
8 hours, with some fully set up, staffed, and ready to open within 6 
hours.
    RAMPEx helped identify critical planning gaps and solutions. First, 
all PODs were ready to open up to 4 hours before medications from CDC's 
Strategic National Stockpile (SNS) would arrive at New York City 
warehouses. In an effort to close this gap, the Health Department has 
requested that SNS assets be forward-deployed in reasonable and useful 
quantities to NYC and other high-threat, high-density urban areas that 
have demonstrated an ability to stand up PODs faster than SNS 
medications can be delivered. The consequence of the failure to 
forward-deploy SNS assets may ultimately be measured in the numbers of 
lives lost because of delayed access to medication.
    Second, we have not met our POD staffing goals for both leadership 
and general staff. In NYC alone, city-wide prophylaxis distribution 
will require 33,000 POD staff to support 48 hours of dispensing 
operations. In anticipation of ``role abandonment'' or failure to 
report, NYC has made great efforts to recruit, pre-train, and assign 
staff to a POD site close to home. We are advocating for non-mission-
critical Federal staff, who live locally, to be similarly pre-
identified and pre-trained to support POD operations. There are many 
areas in which Federal staff could be utilized to augment local 
response efforts during a large-scale emergency, PODs being one such 
opportunity.
    RAMPEx demonstrated New York City's extensive medical 
countermeasure capabilities and high level of readiness for this type 
of scenario, and the importance of Federal preparedness funding to 
sustain such efforts.
          importance of federal emergency preparedness funding
    Our successful Ebola response and medical countermeasure exercise 
are a direct result of a decade of Federal investments in local 
preparedness. However, the greatest danger to our progress is the 
decline in Federal emergency preparedness funding. Preparedness is an 
on-going effort that must be sustained over time. While the overall 
emergency preparedness and response funding should be increased, 
funding allocations should also be based on risk to reflect the scale 
of threat, impact to high-density urban areas, and complexity of 
response. These funds support the development, maintenance, testing, 
and continued improvement of these public health and health care 
capabilities and without these funds, lives would be lost.
    Federal funds have allowed us to build critical capabilities so 
that when faced with public health emergencies, we have the tools 
necessary to protect the public. The Department relies on the dedicated 
emergency preparedness Federal funding streams of PHEP, HPP, and UASI 
to build and maintain these critical public health and health care 
capabilities. Significant cuts to the PHEP award, combined with similar 
cuts to the HPP award jeopardize NYC's, and other State and local 
jurisdictions' existing capabilities and impede planning to address 
known gaps. I will speak to the cuts New York City has endured 
specifically.
    PHEP funding for New York City has decreased 35% from its peak in 
fiscal year 2005, which has led to a 47% reduction in our public health 
preparedness and response workforce. The erosion of a skilled, 
dedicated workforce including epidemiologists, laboratory technicians, 
and preparedness planners threatens to compromise our ability to detect 
and respond to disease outbreaks. In New York City, for example, the 
cuts have reduced the ability of the Public Health Lab to respond to 
after-hours lab testing needs, which is critical to the 24/7 response 
needed for bioterrorism incidents and public health emergencies such as 
pandemic influenza and Ebola.
    Similarly, drastic cuts of nearly 40% to HPP have impeded 
preparedness and response efforts necessary to shore up our Nation's 
health care sector. Health care system preparedness is essential to 
responding to all types of public health emergencies. During the recent 
Ebola response, every hospital had to be ready to identify, isolate, 
and stabilize any patient with potential Ebola disease and a handful of 
hospitals had to be ready to provide intensive treatment for a 
confirmed Ebola patient. There are 55 hospitals, 259 long-term care 
facilities, 303 primary care centers, 50 urgent care centers, and 101 
dialysis centers in New York City. Preparing a health care system of 
this size and complexity requires significant resources, and as the 
funding has declined, NYC's ability to fully prepare its health care 
system has been compromised.
    In the immediate months following a particular emergency, 
jurisdictions have occasionally received one-time funding to supplement 
the PHEP and HPP grants. New York City is thankful to have received 
such an allocation for our Ebola response. However, these singular 
funding allocations are not an adequate substitute for sufficient and 
sustained base funding. There is also a critical need for a real-time 
funding mechanism to support public health emergency response. 
Currently, we must use Federal preparedness funds to cover response 
costs, however with decreasing budgets that are already allotted to 
preparedness projects, this is unrealistic. Generally speaking, Federal 
budgets designed to support public health and health care system 
preparedness and response capabilities must be increased and sustained; 
this is as true for New York City as it is for localities Nation-wide, 
particularly dense urban centers.
    Chairman McSally and Ranking Member Payne, thank you once again for 
inviting me to testify today. We are grateful for your and your 
colleagues' work to protect our citizens. I look forward to your 
questions.

    Ms. McSally. Thank you, Ms. Raphael.
    The Chairman now recognizes myself for 5 minutes for 
questions.
    I appreciate all the testimony and the expertise at the 
table here.
    Senator Talent, I want to start with you. I mentioned in my 
opening statement about the threat coming, potentially, from 
ISIS and, you know, those that are inspired by ISIS. Obviously, 
we have foreign fighters that are flowing in and out of the 
area. We have home-grown, lone-wolf--but we had somebody 
testify saying they prefer to call them ``stray dogs'' instead 
of ``lone wolf'' in one of our previous hearings. But, also, 
obviously, the capability is right there in Iraq and Syria, the 
potentiality.
    I learned in my military career, obviously, threat equals 
intent and capability. So you have to have those two together. 
I think we can all agree that extremist organizations out there 
certainly would want to have the intent if they could, so the 
issue related to the threat is the capability.
    In order to have that capability, you must be able to 
isolate, weaponize, and then disperse the agent. So, of those 
three steps, which do you think is the biggest challenge or 
barrier for extremists out there, both organized and inspired, 
less organized, so that we can try and get a good sense of what 
we are dealing with in the threat?
    Mr. Talent. My understanding of the science--and I will 
certainly invite Dr. Cairns and the deputy commissioner to 
weigh in here--is that probably, of the three, the weaponizing 
it would be the most difficult but, nevertheless, within the 
capability of a fairly wide range of professionals in life 
science. So, really, the issue is can they have a long enough 
period of sanctuary where they can plan, recruit, get the 
necessary lab facilities so that the experts that they have can 
isolate and weaponize.
    That is one of the things that concerns me. Because we are 
seeing areas now--you mentioned Iraq, Syria, but Yemen--there 
are places in North Africa, which you are more well aware of 
than I, where they may have the necessary time and the 
necessary sanctuary to be able to develop this. So that is my 
concern.
    You know, you said it at the beginning, and correct, it is 
a low-probability but very highly destructive event if it were 
to occur. The problem is, when you keep running risk and the 
risk continues to grow, even gradually, you know, eventually, 
the bullet is in the chamber, if you will. This is really what 
concerns me.
    So I am concerned that the risk that they will be able to 
acquire it is growing because they are spreading, they are 
getting more sophisticated, and the logic of this, from their 
strategic point of view, is, I think, very strong.
    Ms. McSally. Thank you. Yeah, no, I agree; the ungoverned 
spaces that are continuing to grow around the world provide 
that space for this kind of activity to happen. If we don't 
have partners in the region to be able to provide governance 
and oversight of those activities, that is where the threat can 
continue to grow, I think, so----
    Mr. Talent. I don't want to take your 5 minutes----
    Ms. McSally. Yeah.
    Mr. Talent [continuing]. But whoever did----and we know who 
the FBI thinks sent the letter here, for example.
    Ms. McSally. Right.
    Mr. Talent. Well, if that had been put into the heating and 
air conditioning system instead of sent in a letter with a 
warning note----
    Ms. McSally. Right.
    Mr. Talent [continuing]. I mean, the destruction would have 
been much, much greater, and the damage.
    Ms. McSally. Thank you.
    Dr. Cairns, in Ms. Raphael's testimony, she talked about 
the preparedness of New York City related to the Ebola crisis. 
We often talk about New York City as a potential target area, 
and we have talked about it even in the chemical threat. So it 
seems the preparedness and the efforts that you took are very 
admirable.
    Do you see, Dr. Cairns, that type of preparedness around 
the country? I would think other cities, other smaller cities, 
you know, even Phoenix or Tucson, other places, would not have 
had that same capability or response. Have we spread the 
lessons learned from the Ebola event to other areas so that we 
can learn from their preparedness?
    Dr. Cairns. Well, thank you very much for the question.
    I think that the deputy commissioner outlined what is a 
best practice, in terms of response to these kinds of entities. 
So, no, I don't think Tucson and Phoenix would have that same 
experience, nor would they have those resources.
    So we need to incorporate, of course, the learnings from 
New York City, but we have to think about: How do we have a 
dedicated isolation unit the way Bellevue was set up? Our 
hospitals are overwhelmed now, so having that dedicated space 
just in case is just a luxury we haven't been able to invest 
in. Then how do we deal with other issues that involve the 
populations outside--Tucson, Phoenix, or any number of Western 
States? How do we make a difference for everywhere for anything 
at anytime, I think, would be one of our big challenges.
    Ms. McSally. Great. Thank you.
    My time has expired. We might have time for a couple rounds 
of questions here, but I want to now recognize Ranking Member 
Payne for 5 minutes.
    Mr. Payne. Thank you, Madam Chairman.
    You know, if you could describe some of the lessons learned 
from the Ebola cases in the United States last year and how 
they might apply to a biological attack scenario, Dr. Cairns.
    Dr. Cairns. Thank you very much for the question.
    I think some of the lessons we learned from Ebola is that 
we need to be prepared to be able to collect data rapidly, have 
a system in place to understand the place of countermeasures, 
and then look at the effect of countermeasures on both 
individual patients and as a collective. We currently don't 
have that system in place. So I think the first lesson is we 
need to be prepared not only for operational experiences but 
also to better understand the impact and value of our 
countermeasures.
    I think another key lesson is that it has been very 
difficult. It has been my experience, working with DHS and HHS 
across multiple agencies on how we might develop that, both 
across the clinical groups, professional organizations, and 
coordinate with the rest of the world, that it became very 
difficult. Frankly, we had more interactions on a standardized 
case form with our clinical trial groups in Canada, New 
Zealand, Australia, and the Europeans and the World Health 
Organization than we did within the United States.
    So I think we really need to start addressing this as a 
National priority and be prepared to get timely information, 
effective assessment to countermeasures, and a system to 
deliver those countermeasures to the patients that would 
benefit most.
    Mr. Payne. Thank you.
    Senator Talent.
    Mr. Talent. I was discouraged by several aspects of the 
Ebola response.
    In our last report, we actually gave the best grade for our 
Government's preparedness to communicate, both among health 
care professionals, to the public, and within the Government. 
That seemed, to me, to be a major failure. This was a small-
scale event. I mean, it is important to think of this in terms 
of from small-scale noncontagious to large-scale contagious. So 
that was very distressing.
    I don't--we established an Assistant Secretary for 
Preparedness and Response, who I had hoped was the one 
coordinating all this, and didn't see the Assistant Secretary 
for Preparedness and Response. So there were malfunctions 
there.
    What we are seeing here is, when we have, as in New York, 
unified authority which sets priorities, we have good use of 
dollars, you know, we spotlight the weaknesses, we know what we 
need to do. When we don't have that, we have problems on the 
ground that we didn't expect, and we are not sure what to do 
about it.
    So I think, again, it points back to the need for a greater 
unit of leaderships either in a person or in a small group of 
people who are able to look at the whole picture from the 
Federal point of view, identify what needs to be done, and have 
the authority to act when the crisis arises.
    Mr. Payne. Thank you.
    Ms. Raphael.
    Ms. Raphael. So I think I want to make three key points.
    So one is just how resource-intensive this kind of response 
is. I think sometimes we slip in to referring to Ebola as past 
tense, but our reality is this is still going on. We have hit 
the 2,300 mark in terms of number of people monitored. We are 
monitoring over 190 people on any given day. So this is an 
incredibly resource-intensive response. We have been using over 
a thousand of our staff. Many millions of dollars have been 
expended on the part of the city.
    I think one of the key challenges is maintaining a 
permanent state of readiness. I can't stress enough how the 
success of our response was really built on all of the 
capabilities that we have developed over the last decade. We 
would not have had the response we had if we hadn't had those 
investments in basic surveillance, labs, communications 
capabilities.
    Obviously, the health care system played a critical role in 
this response. They are required to also have a baseline level 
of readiness, not only for Ebola but for any emerging 
infectious disease. So continuing to invest in the preparedness 
and readiness of the health care system is critical.
    Then, finally, we are dependent on the Federal Government 
for consistent guidance that is based on best practices that we 
can all look to and be on the same page.
    Mr. Payne. Thank you.
    You know, that harkens back to my point and being adamant 
about, you know, the Commission's report that talked about 
reestablishing the position of special assistant to the 
President on biodefense. The coordination that you speak of 
would be enhanced by someone that that was their job and their 
due diligence every single day, to advise the President.
    Senator Talent, in your testimony, you stressed that the 
Government's preparedness for biological attacks received an F 
in your 2010 report. You specifically mentioned the lack of 
sufficient medical countermeasures as your No. 1 concern.
    What can the Government and private sector do right now to 
improve preparedness for biological incidents?
    Mr. Talent. I think this should be a focus of the 
subcommittee, in part because this is the one area, one link in 
the chain where it is really Federally dominated, right? I 
mean, you all have control, as a jurisdictional matter, over 
what FDA is doing, what BARDA is doing, what HHS is doing.
    So I think we have to improve the stockpile. We ought to do 
for other biological agents what we have done for smallpox and, 
to some extent, for anthrax; and then continue to support FDA. 
They are moving in the direction of having the resident 
capacity to be able to respond and come up with new drugs 
quickly.
    I think it is also very important--one of the things Ebola 
showed us is diagnostics is hugely important. We have to put 
effort into being able to diagnose quickly. If you can't do 
that, you can't respond.
    I would also say to you that it is important that the drugs 
that we stockpile, that we take into account the need of 
particular populations--the elderly, women who are pregnant, 
children--because countermeasures that will work with young, 
healthy people may be too much for them. So I think that is 
definitely an area where we ought to move.
    Again, this unifying responsibility--I just leaned over to 
Dr. Cairns a minute ago because he said, how can we have an 
isolation unit the way they do in Bellevue? Well, you all know, 
as all of us do who have served here, VA has a lot of excess 
capacity, right? So if we had a sort of unified leadership 
response, this is an area you would at least like to look into: 
Could we use some of the VA's excess capacity to supply--and it 
is all throughout the country, too, right, or at least through 
a lot of places.
    But, at least as of the time we did our report, VA wasn't 
really even involved in the Federal response. Again, I think 
the problem is there is no special assistant and then, within 
the Congress, there is no way to move in a unified way to send 
a signal from the highest level of political authority.
    Mr. Payne. Okay.
    Well, Madam Chairman, I see my time is up, so I will yield 
back.
    Ms. McSally. We should be able to come back to you, though.
    The Chairman recognizes Mr. Walker from North Carolina.
    Mr. Walker. Thank you, Madam Chairman.
    I wanted to follow up on what my colleague was just talking 
about. I am married to a family nurse practitioner who works in 
a Level 1 trauma center, but, over the last month, she spent 
about five or six shifts on a trauma helicopter as their chief 
trauma nurse and really works a lot with these first responders 
on different issues. These are really the salt-of-the-earth 
people who face and run into situations without asking 
questions, whatever it might be. I particularly am concerned 
about, are we looking out for these guys in the best capacity?
    In driving to my question for both Dr. Cairns and former 
Senator Talent, the medical community seems to have a knowledge 
or understanding--or they are getting there--of what is going 
on, of what they might be facing, yet it seems the larger 
communities, whether you want to call it awareness or the 
action steps or whatever, it just seems like the threat isn't 
really understood or appreciated to that level.
    My question is, what is it that can be done from local 
communities, out of our positions here in Congress? What is it 
that you see would be not just awareness--we talk so much about 
awareness--but what are the action steps that we could take to 
bring some of the awareness?
    I would address that to both of you gentlemen.
    Mr. Talent. It is tough. The Chairman mentioned, you know, 
you don't want to panic people, but you want them to be aware 
of the threat.
    A couple of small steps. I mean, we could do a better job 
within this body of making sure that Members are aware. Now, 
obviously, the Members of this subcommittee and the committee 
are more aware. I am not so sure that your colleagues who are 
not sitting here are aware. I said to the Chair before the 
hearing: We do a lousy job of orientation on National security 
issues in general for new Members coming into this body. As the 
Members know more--because you all network so much back home; 
you talk to your press--I think that would help a lot.
    HHS, as of the time we did our report, they had some 
websites, they were doing some things. As we said, we felt a 
little bit better about communications. But my sense is it has 
probably declined, and I think the funding cuts are one of the 
reasons.
    I mean, one of my real concerns--I agree with the deputy 
commissioner on this. When we issued our report, it was just 
when the funding cuts for public health were coming into play, 
and it is hard for me to believe that any link in this chain 
has gotten better given what has happened to the budget 
situation.
    Mr. Walker. Okay.
    Mr. Cairns.
    Dr. Cairns. Again, thank you for that question.
    Indeed, one of the things that we think is very important, 
Congressman, is for first responders to be integrated into the 
system. So we developed the NCBP system based on the 
experiences and the perspectives of EMTs and paramedics and 
increasingly are trying to reach out to highway patrol, police, 
and fire so that they at least have the information needed to 
both understand a situation they might be going into as well as 
contribute information that can be integrated into the larger 
collective.
    They are just a critical component of our Nation's health 
care system. They clearly are going to be not just the tip of 
the spear, but they are first in time, in getting an 
understanding. They need to be protected.
    Mr. Walker. Sure.
    Dr. Cairns. They need to be aware.
    Mr. Walker. I had a meeting this morning where I found out 
for the first time a piece of legislation--I believe it is H.R. 
1300 that is out there that would specifically allow first 
responders to some of the vaccines in our medical database. Do 
you agree with that? Do you approve of that? Or what would your 
position be?
    Dr. Cairns. I would approve of that; in fact, a movement 
towards community paramedicine, where we take advantage of the 
prehospital care system and EMS system to help take care of 
patients every day--people who are in assisted living 
facilities, people who have to have care at home, those special 
populations that Senator Talent referred to. Why not utilize 
these people and their expertise and their interaction with the 
community to facilitate every-day care?
    So, most certainly, giving them an option to participate in 
a response, I think, would be a valuable adjunct.
    Can I make one comment about medical countermeasures?
    Mr. Walker. Sure.
    Dr. Cairns. I do believe the FDA is making progress. In 
fact, they have supported the U.S. Critical Illness and Injury 
Trials Group to try to come up with ways to be proactive in 
data collection and assessment of medical countermeasures.
    So continuing to work with ASPR, FDA, as well as Homeland 
Security, in order to empower and embrace the effective 
countermeasures for use by paramedics, EMTs, and first 
responders, I think, should also be a priority.
    Mr. Walker. Senator, did you want to add anything to that 
as far as----
    Mr. Talent. I think, in terms of communication, one of the 
things I always believed is that people will pay more attention 
if there is something they can do. So, I mean, to the extent 
that we can give advice to people about how maybe they could 
prepare, again, you want to be careful.
    I think I would start with some of the bigger cities that 
are at a higher risk and give people an idea--and, generally, I 
think, when you are talking about management of these things, 
you are working through local authorities, as in New York. 
Okay? So the logical way to approach it would be to have a best 
practices out there; let other cities, maybe in order to get 
funding, present plans, one of which ought to include public 
awareness and also would include protecting local responders, 
taking advantage of resources outside of the traditional 
medical system--because if we get a big event, there is just no 
way that the surge capability of the hospital is going to be 
able to deal with it. I think they have estimated hospitals can 
surge to, like, 20 percent, something like that, and you could 
have many, many times that.
    As far as FDA is concerned--and I just don't know because 
it has been, like, 3 or 4 years--have they used--now I don't 
want to ask the question. They were considering approving new 
drugs based on animal testing, which we thought was important, 
but, as of that time, they hadn't ever done it. I don't know if 
that is being pursued, but it is a question I would ask if I 
were you.
    Mr. Walker. Thank you, Madam Chairman. I yield back.
    Ms. McSally. Great. Thank you.
    You guys up for a second round here of questions while we 
have our distinguished panel here?
    So I believe in one of the testimonies or some of the 
background we talked about there is about maybe 15 different 
agents that potentially we think could be used for 
bioterrorism, but we really only have countermeasures available 
for about 2 or 3 of them.
    What is the barrier for us to be able to have, you know, 
the countermeasures for the other 12? Is it a resource issue 
only? Is it a political will or a biological solution? I just 
want to get a sense of what are our barriers.
    Because I agree with Senator Talent that we are talking 
about the threat today, but the one way to reduce the threat is 
to be prepared. One way to be prepared, obviously, is to have 
those countermeasures in place.
    So, Dr. Cairns, what is the barrier to having 
countermeasures available for the rest of those so that the bad 
guys would have to go further down the list developing 
capabilities?
    Dr. Cairns. Well, we need to emphasize the development of 
these countermeasures. We have to facilitate pathways, 
including animal testing, that then can be applied in like 
clinical scenarios. Frankly, that is one of the things we have 
just developed with FDA, in conjunction with ASPR, is a way to 
think about how to do that for one of those key agents on that 
list.
    But we also have to think about how we can rapidly adapt to 
changes either in virulence of a particular organism or the 
emergence of something we have known about for a long time like 
Ebola. So being prepared about how we not only test and 
reassess the value of those countermeasures, but to have it as 
a priority to have them developed.
    There were so many countermeasures available for Ebola, for 
example, yet we didn't test any efficacy on most of these, and 
yet that program could be vital in the future. Imagine all the 
rest of the 15 agents on that list and how we might actually 
apply them to people who need them.
    Ms. McSally. Great.
    Senator Talent, do you have----
    Mr. Talent. Yeah, I think part of the issue is, as I 
understand it, okay, NIH does a lot of the basic science. HHS 
is supposed to coordinate setting priorities and requirements, 
and then BARDA is supposed to actually develop the 
countermeasures. I think there has been a lack of, again, 
coordination in decision making about what are we going to 
focus on, you know, decisions about when animal testing is good 
enough--I don't want to get into the science of it.
    Then BARDA has been underfunded. It is being funded at a 
fraction of what it needs. You know, I know we don't just throw 
dollars at a system that is not working otherwise, but I think 
we are going to have to do more in terms of funding there.
    Since that is the one aspect of this that is the complete 
Federal responsibility, really--I mean, if you don't have the 
countermeasures, you can have all the rest of it done--it is 
like an army without bullets, I think I said in the testimony.
    Ms. McSally. Great. Thank you.
    In the fiscally-constrained environment that we are in, I 
am always going to be asking what is doable. Like, you know, as 
we talked in the back earlier, Senator Talent, like, what is 
the low-hanging fruit that is actually doable in this fiscal 
environment, in this divided Government, that we could maybe 
get some bipartisan agreement on and to address some things 
incrementally. I mean, we have a whole host of challenges, some 
of which have been brought up today, some we haven't even 
touched on.
    But what do you think, Senator Talent, is actually doable 
in this environment, that this subcommittee could move through 
in a bipartisan way and get signed by this President, that 
isn't, you know, significant resources? We have to make that 
case, certainly, to our colleagues and others, but I also want 
to get something done and not have the perfect be the enemy of 
the good.
    Mr. Talent. Well, I do think--and Mr. Payne mentioned 
this--fixing the authority situation. I am not sure how to go 
about it from an Executive branch point of view. I would 
support the legislation you all have sponsored. At the same 
time, it is not the best thing in the world in legislation to 
tell the President how he has to organize his own staff. But I 
support what you are doing because I think it is so urgent.
    So, just as a practical matter, this might be an 
opportunity for the leadership or your Chair and Ranking Member 
to go talk to the chief of the staff, if you haven't done it, 
and just say, ``Hey, how come you haven't done this?''
    I mean, the President is personally, obviously, aware of 
this. He has talked about it in his National security strategy. 
He has responded personally and taken a lot of initiative on 
cyber, for example. That is clearly something he is interested 
in. So I think sometimes it is just making somebody personally 
aware of it.
    I would look at how you can empower all these tremendous 
assets we have out there--local health departments, first 
responders. They have such a tradition of partnership and 
mutual aid anyway. I would ask people like the deputy 
commissioner, are there issues relating to potential liability 
that has hampered you in New York, for example, in 
distribution? Are the big box retailers--I don't know how many 
you have in New York--but are they not--so I would look at some 
of the non-money things.
    Then, in terms of what you are doing with the money, I 
would focus on two things: Offering funding to localities that 
come up with really good plans for distribution and managing 
surges; and fixing the stockpiling issue. That is going to take 
more money. I know it is hard, but--and it is going to take 
consistency, too. You know, it is hard when you are planning 
this and then one year it is here and the next year it is here. 
So speak to the appropriators and get them to be consistent in 
funding. Good luck with that, right?
    Ms. McSally. Yeah, thanks. Thanks a lot. We will get right 
on that.
    So it seemed to me also that just sharing information is 
important, that when we have best practices or lessons 
learned--in the military, we would call them lessons 
identified, because it seems like we constantly are identifying 
issues but we are not learning them--how do we share them 
across both, you know, the levels of Government and how do we 
share them across metropolitan areas?
    That should not be very costly, just being able to share 
information.
    Ms. Raphael or Dr. Cairns, do you have any comments on--it 
seems to me we could do that kind-of on the cheap, you know, 
just setting up procedures to collaborate and share 
information.
    Ms. Raphael. Sure. So, I mean, I think New York City 
certainly recognizes that we outresource many jurisdictions and 
we are much further along in our planning. So we always welcome 
the opportunity to present on our work, share our work. We see 
a lot of what we are doing as really a National model. So we 
take that very seriously. We just spent last week at an annual 
preparedness summit, where we did a number of presentations and 
had a lot of interest in the work we are doing.
    I have, over many years now, stressed to both CDC and ASPR 
that they have a very particular perspective, in terms of who 
is strong in what, and that they should really be sharing that 
information. They are assessing, essentially--they have a 
viewpoint of where each jurisdiction is in their capability 
development. I think they could be doing more to match those 
that are stronger in certain capabilities with those that are 
weaker. But it is only the Federal Government that I think has 
that higher level of perspective.
    Ms. McSally. Dr. Cairns.
    Dr. Cairns. I agree that we need to share information and, 
frankly, need to share data, not just with local groups and the 
Federal Government but across the Federal Government.
    The National Biosurveillance Integration Center, for 
example, has been kind-of pigeonholed into looking at open-
source data, and my understanding is that they are not getting 
data from the CDC BioSense Program, for example. So having data 
shared across Federal agencies and made available to State and 
local officials who have this responsibility to respond and 
understand the situation and employ countermeasures would be a 
very valuable step forward.
    Speaking of the VA, you know, I think there is a real 
opportunity to utilize the VA system and VA data, which is 
standardized and available across the country, but those data 
aren't integrated into the system either.
    So I think having shared data, shared information, and a 
collective response to this issue of preparedness as well as 
countermeasures would be a very valuable first step.
    Ms. McSally. Great.
    Senator Talent, final comments on that?
    Mr. Talent. Just 30 seconds. We haven't mentioned 
remediation here with the last link in the chain. Anthrax is 
the classic one. That could be an area, also, where the Federal 
Government--we all could act pretty much as a Government.
    I mean, I have often thought that this capacity ought to be 
resident maybe in DOD or the Reserves because they do so much 
anyway in terms of chem-bio, in terms of battlefield 
preparation. It is not fair to task all these localities to 
come up with their own remediation when you really only need, 
like, one team that can go in and do it.
    I bet that could be done pretty inexpensively, too. I 
wouldn't just add it without any funding, but we need the 
ability to come in and clean up. You know how long it took them 
to clean up the Hart Building after Senator Daschle's office 
got--it took 6 months, I think, or longer.
    So that is another area you could explore.
    Ms. McSally. Great. Thank you.
    You just reminded me--I know we are out of time here, but 
the use of the National Guard, is that a part of, Ms. Raphael, 
your planning for distribution?
    Ms. Raphael. So, just to note, we did use the National 
Guard for our Hurricane Sandy response. They were a prominent 
part of our response, but it is not currently our plan. So 
something that has been drilled in State and locals from very 
early on is that you need to be ready to prepare at that level. 
You know, yes, Federal Government will provide assistance, but 
don't, sort-of, bank on that on the first hours. So all of our 
staffing is sort of local-based.
    That said, the two things we are really asking of Federal 
Government is, No. 1, to give us access to their non-mission-
critical staff that are locally-based. As I mentioned, we need 
a lot of staff to run these PODs. We need to run them in 48 
hours and get meds into people as quickly as possible. So that 
is something we have been really pushing for.
    Then the other thing we are completely dependent on the 
Federal Government for is the Strategic National Stockpile. We 
are in a position where our distribution plans are so advanced 
that we are ready to open before the medications arrive. We 
will literally be ready, public standing at the door, and we 
will not have the medication. That is just a huge problem.
    Ms. McSally. Okay. Great. Thank you.
    My time is very expired, so I will hand it over to Mr. 
Payne now.
    Mr. Payne. Thank you, Madam Chairman.
    Deputy Commissioner Raphael, I understand that the RAMPEx 
began with a fictitious BioWatch Actionable Result, or BAR. 
What happens after a BAR? Does the Federal Government provide 
adequate support in evaluating how to respond to a BAR?
    Ms. Raphael. Funny you should ask that. So, you know, we, 
sort of, got these BioWatch filters and were told: Okay, figure 
out what you are going to do with them. So, we have no funding, 
so we have figured out, sort-of, at the local level what we 
would do if there was a positive hit.
    Something we have been asking of the Federal Government for 
literally years is for there to be some sort of interagency 
working group among all the different Federal agencies so we 
could understand what every Federal agency's role is. Because 
it is not clear to us exactly what the Federal Government would 
do in the case of there being a positive result.
    We know what we will do as a city. Obviously, requesting 
and receiving the SNS as quickly as possible will be a key 
component to that. But in regards to some of the remediation 
issues, a lot of those issues are really outstanding, and we 
really need the Federal Government's help.
    Mr. Payne. Thank you.
    Also, during the Ebola crisis last fall, you know, State 
and local public health organizations and hospitals were 
bombarded with guidance materials and updated protocols.
    Can you talk about what worked and what needed improvement 
with respect to the Federal Government's efforts to push 
guidance and other information out to the local and public 
health organizations?
    Ms. Raphael. So I think one thing that would be helpful, to 
the extent possible, is having some sort of State and local 
representation on some of these guidance discussions so that 
there is an understanding of what it would mean on the ground 
in terms of implementation, or at least having more of a heads-
up in terms of what is coming.
    Because I think a huge challenge for us was constantly 
changing guidance on a regular basis. Here we were, trying to 
implement a response, be flexible, be nimble, and then the 
guidance would change the next day.
    So I think, you know, having thoughtful guidance coming 
out, with appropriate input into the process.
    Mr. Payne. Okay.
    Just one last question to Ms. Raphael. I felt like you 
weren't given much opportunity, so I am going to focus down 
your alley for a bit.
    But, you know, in your testimony, you discussed the 
planning for role abandonment--basically, workers not showing 
up to operate the PODs. What can the Federal Government do to 
help prevent role abandonment?
    Ms. Raphael. Give us money.
    So I think the most important----
    Mr. Payne. Never mind.
    Ms. Raphael. No, I mean, continue to provide us with 
funding.
    I think the No. 1 investment for us as New York City--you 
know, I think we have been held up as a best practice. The 
reason why our planning is so advanced is because we have 
dedicated staff that are working on this every day.
    Some of the advancements include pre-identifying and pre-
assigning every single health department staff to a POD role, 
to a POD site. They know exactly what POD location they are 
going to. They are assigned based on their home address so that 
they can walk there if mass transit goes down.
    We pre-developed, sort-of, phase one PODs, where we have 
pre-identified the first 30 through 80 PODs that would open up. 
Everyone knows what those are; the police department knows what 
they are. We literally hit a switch, and it happens.
    So I think we just really need sustained funding to 
maintain this capability. If the funding goes down more or goes 
away, we will not have this capability.
    Mr. Payne. Thank you.
    You know, just in wrapping up, you know, those are the type 
of examples that deserve funding. If, you know, you are being 
that conscientious and that dedicated to it, those best 
practices and the things that you are doing in New York City 
should be held up as an example of what and how to do this and, 
based on your success rate, all should be part of the factor in 
funding, I believe.
    So thank you to all of the witnesses today.
    Madam Chairman, I yield back.
    Ms. McSally. Thank you, Mr. Payne.
    I thank all the witnesses here today and your testimony. 
This is the start of a discussion with this subcommittee. For 
sure, there is a lot more work to be done, and I think we will 
be probably following up with you, additional questions on 
individuals we can meet with or in our other role of oversight, 
in addition to hearings on legislation to address some of these 
issues.
    So I really appreciate your testimony today and your 
expertise and what you are doing to address this threat.
    Members of the subcommittee may have additional questions 
for you in writing, and so we will pass those on to you if they 
do. Pursuant to committee rule 7(e), the hearing record will be 
open for 10 days for those questions.
    Without objection, the subcommittee stands adjourned.
    [Whereupon, at 11:17 a.m., the subcommittee was adjourned.]

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