[Senate Hearing 114-639]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 114-639

    THE FEDERAL PERSPECTIVE ON THE STATE OF OUR NATION'S BIODEFENSE

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

                                HEARING

                               before the

                              COMMITTEE ON
               HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
                          UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS


                             SECOND SESSION

                               __________

                             APRIL 14, 2016

                               __________

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        COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

                    RON JOHNSON, Wisconsin Chairman
JOHN McCAIN, Arizona                 THOMAS R. CARPER, Delaware
ROB PORTMAN, Ohio                    CLAIRE McCASKILL, Missouri
RAND PAUL, Kentucky                  JON TESTER, Montana
JAMES LANKFORD, Oklahoma             TAMMY BALDWIN, Wisconsin
MICHAEL B. ENZI, Wyoming             HEIDI HEITKAMP, North Dakota
KELLY AYOTTE, New Hampshire          CORY A. BOOKER, New Jersey
JONI ERNST, Iowa                     GARY C. PETERS, Michigan
BEN SASSE, Nebraska

                  Christopher R. Hixon, Staff Director
          Gabriel S. Sudduth, Senior Professional Staff Member
             Lexia M. Littlejohn, U.S. Coast Guard Detailee
              Gabrielle A. Batkin, Minority Staff Director
           John P. Kilvington, Minority Deputy Staff Director
        Robert H. Bradley II, Minority Professional Staff Member
    Marian P. Gibson, Minority U.S. Department of Homeland Security 
                                Detailee
                     Laura W. Kilbride, Chief Clerk
                   Benjamin C. Grazda, Hearing Clerk
                   
                   
                            C O N T E N T S

                                 ------                                
Opening statements:
                                                                   Page
    Senator Johnson..............................................     1
    Senator Carper...............................................     2
    Senator Booker...............................................    20
    Senator Peters...............................................    22
    Senator Ernst................................................    25
    Senator Portman..............................................    27
    Senator McCaskill............................................    29
Prepared statements:
    Senator Johnson..............................................    37
    Senator Carper...............................................    39

                                WITNESS
                        Thursday, April 14, 2016

Richard J. Hatchett, M.D., Acting Director, Biomedical Advanced 
  Research and Development Authority, Office of the Assistant 
  Secretary for Preparedness and Response, U.S. Department of 
  Health and Human Services......................................     4
Stephen C. Redd, M.D., Director, Office of Public Health 
  Preparedness and Response, Centers for Disease Control and 
  Prevention.....................................................     6
Kevin Shea, Administrator, Animal and Plant Health Inspection 
  Service, U.S. Department of Agriculture........................     7
Aaron M. Firoved, Ph.D., Director, National Biosurveillance 
  Integration Center, Office of Health Affairs, U.S. Department 
  of Homeland Security...........................................     9
Christopher P. Currie, Director, Homeland Security and Justice, 
  U.S. Government Accountability Office..........................    11

                     Alphabetical List of Witnesses

Currie, Christopher P.:
    Testimony....................................................    11
    Prepared statement...........................................    82
Firoved, Aaron M., Ph.D.:
    Testimony....................................................     9
    Prepared statement...........................................    77
Hatchett, Richard J., M.D.:
    Testimony....................................................     4
    Prepared statement...........................................    41
Redd, Stephen C., M.D.:
    Testimony....................................................     6
    Prepared statement...........................................    59
Shea, Kevin.:
    Testimony....................................................     7
    Prepared statement...........................................    70

                                APPENDIX

Response to post-hearing questions for the Record:
    Mr. Hatchett.................................................   101
    Mr. Redd.....................................................   128
    Mr. Shea.....................................................   155
    Mr. Firoved..................................................   171
    Mr. Currie...................................................   224


 
    THE FEDERAL PERSPECTIVE ON THE STATE OF OUR NATION'S BIODEFENSE

                              ----------                              


                        THURSDAY, APRIL 14, 2016

                                     U.S. Senate,  
                           Committee on Homeland Security  
                                  and Governmental Affairs,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:02 a.m., in 
room SD-342, Dirksen Senate Office Building, Hon. Ron Johnson, 
Chairman of the Committee, presiding.
    Present: Senators Johnson, Portman, Ayotte, Ernst, Sasse, 
Carper, McCaskill, Tester, Booker, and Peters.

            OPENING STATEMENT OF CHAIRMAN JOHNSON\1\

    Chairman Johnson. Good morning. This hearing will come to 
order. I certainly want to thank all of the witnesses for 
taking the time to attend and for taking the time to write your 
thoughtful testimonies. We appreciate it. It will all be in the 
record.
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Johnson appears in the 
Appendix on page 37.
---------------------------------------------------------------------------
    This is an important hearing. I guess I would consider this 
our second hearing on this subject. We had Governor Tom Ridge 
and Senator Joe Lieberman here, earlier, with their Blue Ribbon 
Study Panel on Biodefense, which is a very well-thought-out 
document with a lot of detail. Probably the main takeaway from 
that was the fact that we just have no central authority to 
kind of accumulate all of the data, to accumulate the budgets, 
and really to direct potential activity--particularly in the 
event of a significant outbreak, whether it is--and, of course, 
we have dealt with Ebola and avian influenza. We have had 
hearings on both of those--and, now, the Zika virus.
    In Wisconsin, we have something--and I cannot pronounce 
it--Elizabethkingia meningoseptica. I think I might have 
actually gotten that right. It has infected about 59 people, 
already 18 people in our State. I appreciate the work the 
Centers for Disease Control and Prevention (CDC) has already 
done on that, responding very quickly to a letter I sent. It 
sounds like you have really taken that very seriously and have 
been trying to find the common cause. Very interesting, I 
guess. Troubling in many respects, but, anyway, this is an 
important hearing.
    I do ask consent that my opening written statement be 
entered in the record. But, as with any hearing, the main goal 
is to lay out a reality, so we all understand really what we 
are facing here. And, when it comes to the different types of 
biothreats, these can be very serious.
    Maybe the good news about all of them is that the same 
types of procedures, processes, and kind of management 
structure can be put in place to respond to just about any of 
them, because the threats are always changing, as we are seeing 
just the different type of pathogens and the different 
biological threats that I just listed.
    So, again, I appreciate all of your work and effort in 
this. I appreciate you coming here.
    With that, I will turn it over to Senator Carper.

             OPENING STATEMENT OF SENATOR CARPER\1\

    Senator Carper. Thank you, Mr. Chairman. I understand there 
is a vote at 10:30.
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Carper appears in the 
Appendix on page 39.
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    Chairman Johnson. Yes.
    Senator Carper. Do you want to just keep rolling, or do you 
want us to recess for the vote? Do you have to think about it?
    Chairman Johnson. It would probably be nice to keep rolling 
if we could, so why don't we try--you and I will tradeoff. 
Thank you.
    Senator Carper. OK. Good. So, when the vote starts, I will 
leave--with the Chairman's concurrence--and go vote and come 
back right away. And, you guys can just keep talking. And then, 
we will start asking questions.
    Thank you all for coming. Mr. Chairman, thank you for 
bringing this together. This is an even more important hearing, 
given what is going on with the Zika virus. But, as the 
Chairman has said, last fall we convened a hearing to examine a 
report by this Blue Ribbon Study Panel on Biodefense chaired by 
a couple of our good friends--Joe Lieberman and Tom Ridge. And, 
one of the main points in their report was, there ought to be 
somebody in the Administration, one senior person, to lead it. 
They thought the Vice President would be a pretty good one, and 
so we will see. We had a meeting with the Vice President and 
the two co-chairs, and we will see where that leads.
    But there is a lot of work to be done, and, fortunately, 
the panel provided recommendations to further enhance our 
ability to prevent, to detect, to respond to, and to recover 
from a biological incident.
    Today, we have the opportunity to discuss those 
recommendations with the heads of several agencies--senior 
people in several agencies, who would be responsible for 
implementing some of the recommendations of the earlier panel. 
I am eager to hear your thoughts and also hear how you believe 
we can further improve our country's biodefense system. This is 
an important conversation to have in the context of recent 
global events, including a couple that are emerging even as we 
speak.
    Ebola continues to threaten West Africa, and--after 
claiming thousands of lives--the spread of the virus has 
declined significantly, thanks in no small part to the 
investments that America has made in the health systems of the 
countries that were hardest hit by the epidemic. I think it is 
one of the proudest chapters in our Nation's history as of 
late, and I am very proud of the work that was done, including 
by some of you and the folks that you lead. But, that said, the 
recent news of more cases in Guinea and Liberia underlines the 
need to continue supporting our international partners in their 
efforts to combat this disease.
    We are also almost one year removed from a significant 
outbreak of highly pathogenic avian flu, which decimated some 
parts of our Nation's poultry industry. The Chairman's State 
was badly affected, as were a number of others in the Midwest. 
And, while infections of poultry have been limited in number so 
far this year, thank God, we must remain vigilant and continue 
to enforce good biosafety practices at poultry farms across the 
country to safeguard against another epidemic.
    Meanwhile, we are quickly approaching the beginning of 
mosquito season in most parts of the United States. 
Unfortunately, this presents us with a new threat--this one in 
the form of the Zika virus that we are hearing a whole lot 
about. The virus has spread explosively throughout Central and 
South America. It has already reached Puerto Rico and other 
U.S. territories and is expected to spread further as the 
weather warms. The World Health Organization (WHO) estimates 
that as many as 4 million people in the Americas could contract 
Zika by the end of the year. Researchers continue to learn more 
about the virus every day--but it is clear that the health 
impacts can be devastating, particularly for pregnant women and 
their unborn children. We have all heard that the CDC has just 
recently confirmed this week something that a lot of folks have 
speculated for a while--that the Zika virus is a cause of 
severe birth defects.
    While most of the Zika cases diagnosed in American citizens 
to date have been traced to travel abroad, we must be prepared 
for the virus to present itself locally to us. So, it has been 
encouraging to see a proactive, coordinated response from the 
President and his Administration to this threat. For example, 
Federal agencies are helping State and local governments 
enhance their capacity to better detect and track the virus. 
There are also significant mosquito control efforts underway in 
areas that are most at risk.
    We also know that medical countermeasures and vaccine 
development are being rigorously pursued. We applaud that. To 
help fund these efforts, the Administration announced last week 
its intent to redirect almost $600 million from other 
programs--including funds originally designated for Ebola--and 
spend it on Zika response efforts. I believe the President made 
the right call in this instance. I am glad he has done this. 
While these efforts continue, Congress should continue to 
carefully consider the President's request for additional 
resources to combat this threat.
    In addition, we must ensure that our public health 
officials have the tools that they need to protect us from Zika 
and to prepare us for future threats. But, at the same time, we 
should not let our foot off of the gas when it comes to our 
efforts to contain dangerous diseases such as Ebola and avian 
influenza.
    With that, we welcome each of you. Thank you for your 
service, and thank you for your testimony today.
    Chairman Johnson. Thank you, Senator Carper.
    It is the tradition of this Committee to swear in 
witnesses, so if you will all rise and raise your right hand. 
Do you swear the testimony you will give before this Committee 
will be the truth, the whole truth, and nothing but the truth, 
so help you, God?
    Dr. Hatchett. I do.
    Dr. Redd. I do.
    Mr. Shea. I do.
    Mr. Firoved. I do.
    Mr. Currie. I do.
    Chairman Johnson. Somebody has a snappy tune there.
    Our first witness is Dr. Richard Hatchett. Dr. Hatchett is 
the Acting Director of the Biomedical Advanced Research and 
Development Authority (BARDA) and the Acting Deputy Assistant 
Secretary in the Office of the Assistant Secretary for 
Preparedness and Response (ASPR) in the Department of Health 
and Human Services (HHS). That is a big title. Among his many 
past roles, Dr. Hatchett has served at the National Institute 
of Allergy and Infectious Diseases (NIAID) at the National 
Institutes of Health (NIH), on the White House National 
Security staff, and in the White House Homeland Security 
Council (HSC) as the Director for Biodefense Policy. Dr. 
Hatchett.

  TESTIMONY OF RICHARD J. HATCHETT, M.D.,\1\ ACTING DIRECTOR, 
BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, OFFICE 
OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, U.S. 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Hatchett. Chairman Johnson, Ranking Member Carper, and 
distinguished Members of the Senate Committee on Homeland 
Security and Governmental Affairs, good morning. Thank you for 
inviting me to testify on the state of our Nation's biodefense. 
I am Richard Hatchett, Acting Director of the Biomedical 
Advanced Research and Development Authority, and my testimony 
today will focus on steps taken by the Office of the Assistant 
Secretary for Preparedness and Response to strengthen our 
Nation's health security as well as the contributions of my own 
office toward that end.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Hatchett appears in the Appendix 
on page 41.
---------------------------------------------------------------------------
    We have made substantial progress in the past 10 years to 
advance the State of our national biodefense. Thanks to the 
support of this Committee and others in Congress, we have 
established BARDA and continue to make critical investments in 
biodefense and our health care system. However, as highlighted 
by recent challenges, such as Ebola, Middle East Respiratory 
Syndrome (MERS), and Zika, there remain gaps in our 
preparedness.
    As this Committee is aware, a recent report by the Blue 
Ribbon Study Panel on Biodefense has indicated that the United 
States is underprepared for biological threats and that the 
Nation is dangerously vulnerable to biological events--whether 
natural, intentional, or unintentional in origin.
    Where the civilian, public health, and medical response to 
such events is concerned, the ASPR is charged, by statute, to 
play a strong leadership role. The ASPR serves as the principal 
adviser to the Secretary of Health and Human Services on all 
matters related to Federal medical preparedness and response 
for public health emergencies. The ASPR chairs the HHS Disaster 
Leadership Group (DLG), which convenes in response to 
complicated emergencies, and the Public Health Emergency 
Medical Countermeasures Enterprise (PHEMCE), which coordinates 
medical countermeasures development efforts across the 
interagency. The ASPR is the author and custodian of the 
National Health Security Strategy (NHSS), which focuses on 
protecting public health during an emergency. The ASPR oversees 
2 critical programs that support medical response.
    The first, the Hospital Preparedness Program (HPP), 
enhances medical preparedness and resiliency at the community 
level through its support of health care coalitions.
    The second, the National Disaster Medical System (NDMS), 
deploys medical personnel and related assets when local 
resources are overwhelmed.
    The PHEMCE, for its part, promotes the development and 
acquisition of medical countermeasures for chemical, 
biological, radiological, and nuclear threats (CBRN), pandemic 
influenza, and emerging infectious diseases. PHEMCE 
coordination and decisionmaking encompass all stages of the 
medical countermeasure life cycle, from identifying 
requirements and developing target product profiles through 
product development to distribution and dispensing. The PHEMCE 
has an outstanding record of success and is now being studied 
as a model for global preparedness against emerging infectious 
diseases.
    To date, at least 23 medical countermeasures that BARDA has 
supported have been approved, licensed, or cleared by the Food 
and Drug Administration (FDA) under PHEMCE's purview. Of these, 
15 have been approved since 2011 and 5 have been approved in 
the last 12 months. 17 products--ranging from anthrax 
antitoxins and smallpox vaccines to anti-neutropenia cytokine 
therapeutics for acute radiation syndrome and an array of 
products for the management of thermal burns--have been added 
to the Strategic National Stockpile (SNS) under Project 
BioShield, with another 7 anticipated between now and the end 
of fiscal year (FY) 2018.
    Overall, since the year 2000, the FDA has approved 89 
medical countermeasures for CBRN threats and pandemic 
influenza, as well as 17 supplemental changes to already 
approved applications and 71 modifications to diagnostic 
devices. This investment in preparedness has already paid 
dividends. Because of the workforce and capabilities we have 
developed over the last 10 years, we are much better prepared 
to respond quickly to emerging threats.
    The PHEMCE, for example, facilitated the rapid development 
and deployment of vaccines, therapeutics, and diagnostics 
during the Ebola epidemic and is now fully engaged in the 
response to Zika.
    We know, from experience, that a well-coordinated PHEMCE 
response is a critical enabler of a rapid science and industry 
response. The PHEMCE succeeds not because a set of government 
offices succeeds, but because response efforts across the whole 
of society are supported and coordinated. To respond 
effectively to threats as diverse and unpredictable as the 
biological threats we face, nothing less than a whole-of-
society response will work.
    Thank you again for the invitation to speak with you, and, 
at this time, I would be happy to address any questions you may 
have.
    Chairman Johnson. Thank you, Dr. Hatchett.
    Our next witness is Dr. Stephen Redd. Dr. Redd is the 
Director of the Office of Public Health Preparedness and 
Response at the Centers for Disease Control and Prevention. Dr. 
Redd, who has been part of the Public Health Service for over 
30 years, is responsible for all of the CDC's public health 
preparedness and response activities. Is it pronounced Dr. 
Redd?
    Dr. Redd. Yes, sir.
    Chairman Johnson. OK, great. Thank you. Dr. Redd.

  TESTIMONY OF STEPHEN C. REDD, M.D.,\1\ DIRECTOR, OFFICE OF 
 PUBLIC HEALTH PREPAREDNESS AND RESPONSE, CENTERS FOR DISEASE 
                     CONTROL AND PREVENTION

    Dr. Redd. Chairman Johnson, Ranking Member Carper, and 
distinguished Members of the Committee, my name is Stephen 
Redd. As you have just heard, I am the Director of the Office 
of Public Health Preparedness and Response at the CDC, and it 
is my pleasure to appear today to discuss the work the CDC is 
doing to prepare and respond to threats to the health of the 
public.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Redd appears in the Appendix on 
page 59.
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    As you know, the CDC works to protect the public's health 
by helping communities improve readiness and response. This is 
for chemical, biological, and radiation emergencies--whether 
those are naturally occurring events like the Ebola epidemic or 
the Zika virus epidemic, intentional, or accidental.
    There are two key programs at the CDC that enable us to 
prevent, detect, and respond to public health threats: the 
Public Health Emergency Preparedness (PHEP) Program and the 
Strategic National Stockpile. Both programs had their origins 
before September 11, 2001 (9/11) and the anthrax attacks of 
2001. They were greatly expanded after those events in 
recognition of the need to improve the ability of the public 
health system to respond in scale and in speed.
    The Public Health Emergency Preparedness Program's overall 
aim is to prepare the Nation to respond to public health 
emergencies. Since 2002, $10 billion has been devoted to this 
effort. The program funds 62 awardees: all 50 States, 4 large 
cities, and 8 territories. And what it actually funds are 
staff: epidemiologists, laboratory experts, and risk 
communication experts as well as emergency operations centers, 
laboratory equipment, planning and exercising efforts, and 
efforts to respond--or to correct things that are identified in 
exercises and natural events.
    The Strategic National Stockpile is the national repository 
of life-saving medicines, vaccines, and medical supplies, such 
as mechanical ventilators. Currently, the stockpile holds over 
$7 billion in assets. It operates as part of the Public Health 
Emergency Medical Countermeasure Enterprise, which you have 
heard about. The stockpile procures, stores, and delivers 
supplies in times of emergency.
    Both the Public Health Emergency Preparedness Program and 
the Strategic National Stockpile were instrumental in the Ebola 
response and are being used now as part of the Zika response. 
So let me now turn to Zika.
    As of yesterday, 41 countries have reported local 
transmission of the Zika virus. In the continental United 
States, over 300 travel-associated cases have been reported. 
About 1 in 10 of these are in pregnant women. 7 have been 
acquired through sexual transmission. There currently are no 
local transmissions by mosquitoes, but the problem exists here 
because of these travel-associated cases and sexually-
transmitted cases. In Puerto Rico, there is transmission from 
mosquitoes--over 300 cases. About 1 in 6 of these are in 
pregnant women.
    Just to talk about some of the things that we are doing in 
the response to Zika, you heard from Senator Carper that 
yesterday the CDC authored a publication that concluded that 
the Zika virus infection causes severe birth defects. That 
article also identified a number of the outstanding scientific 
questions.
    On April 1, we convened the Zika Action Plan Summit in 
Atlanta. This brought together State and local health officials 
to review the latest scientific information and to jump-start 
planning at the State and local levels.
    We also issued travel guidance for women who are pregnant 
within 72 hours of identifying the virus in the brains of 
children and fetuses that had died. We have developed 
laboratory tests. We are working closely with local health 
departments and we are implementing mosquito control measures 
with the government of Puerto Rico to prevent transmission to 
pregnant women.
    Public health threats are ever present. Due to the 
investments from Congress, the Nation is better prepared to 
prevent, detect, and respond to health emergencies than we were 
before the events of September 2001. And, at the CDC, we are on 
the frontlines to protect Americans from health threats 
wherever those threats occur. From recent experience, we know 
that we will be called upon to respond in the future.
    Thank you.
    Chairman Johnson. Thank you, Dr. Redd.
    Our next witness is Mr. Kevin Shea. Mr. Shea is the 
Administrator of the U.S. Department of Agriculture's (USDA) 
Animal and Plant Health Inspection Service (APHIS). Mr. Shea 
carries out the agency's broad mission of protecting and 
promoting American agriculture, regulating genetically 
engineered organisms, administering the Animal Welfare Act, and 
carrying out wildlife damage management activities. Mr. Shea.

  TESTIMONY OF KEVIN SHEA,\1\ ADMINISTRATOR, ANIMAL AND PLANT 
   HEALTH INSPECTION SERVICE, U.S. DEPARTMENT OF AGRICULTURE

    Mr. Shea. Thank you, Mr. Chairman, Senator Carper, Senator 
Ayotte, and Senator Booker. I appreciate you all being here 
today to hear us.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Shea appears in the Appendix on 
page 70.
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    At APHIS, over 8,000 men and women work around the world to 
protect American agriculture and natural resources against 
plant and animal pests and diseases. We want to keep them out 
of the country, but if they do get into the country, we have 
the expertise and the tools to detect them, to control them, 
and, hopefully, to eradicate them.
    Although the crux of our mission is plant and animal 
health, we understand that, of course, there is a crucial link 
between plant and animal health and human health. Our 
partnerships with the CDC and other Federal and State agencies 
emphasize this ``One Health'' (OH) approach.
    Animal health can affect human health and human health can 
affect animal health. That is why it is so important that we 
communicate and coordinate with each other. That is why the 
emphasis on ``One Health'' in the ``National Blueprint for 
Biodefense'' is so important and why we strongly support it and 
appreciate that they emphasized it.
    I want to highlight just a few examples of what APHIS does 
with our partners.
    First, we created, within our Veterinary Services Program, 
a One Health Coordination Center (OHCC). This center works 
closely with our internal veterinarians to make sure that they 
are considering the human health aspects of animal health 
programs.
    At the same time, they work with their counterparts in the 
human health arena to make sure those agencies have an 
understanding of how what they do can affect agriculture and 
animal health. Because this communication is so important, we 
have embedded an APHIS veterinarian in Atlanta with the CDC to 
exchange information literally every day.
    We always share information with our partners about our 
well-established zoonotic disease surveillance efforts, and 
when we have information about potentially damaging diseases, 
we share that quickly. Of course, this Committee knows--as the 
Chairman and Senator Carper alluded to earlier--you all know 
the devastating impact avian influenza had last year on our 
producers, but also the impact it had on the availability and 
price of eggs and turkey. 1,000 APHIS employees and thousands 
of contractors and State employees did the important frontline 
work to control that disease, but, behind the scenes, our 
partnerships with the groups with us today were there and were 
very important. Our scientists shared information with the CDC 
about avian influenza--about the virus. We had no reason to 
think that that virus was going to be a human health threat, 
but avian influenza viruses mutate. And so, we were constantly 
supplying information to the CDC so they could develop 
candidate vaccines if indeed it ever should have jumped over to 
be a human health problem.
    We also are working very closely with our colleagues in the 
Fish and Wildlife Service to test wild birds. And, the good 
news is, we tested 43,000 wild birds over the last 9 months and 
have found no more examples of high-path avian influenza in 
those birds. So, that is some hopeful information.
    We spent a lot of time assessing our efforts in controlling 
avian influenza last year as well as on our capability to 
detect it. And, we compiled a very substantial, very large new 
planning document on what we can do to prevent avian influenza 
from becoming a huge problem again. And, we had a chance to 
test that out already. In Indiana, in January, there was indeed 
one case of highly pathogenic influenza and 9 cases of low-
pathogenic avian influenza associated with that. We were able 
to get on top of that, immediately, to wipe that out, and we 
have had no cases of avian influenza other than that since last 
June 17.
    Something we learned, in all of our review, was that we 
need to rebuild our capacity to respond to large animal health 
emergencies. We have 200 fewer animal health professionals--
veterinarians and animal health technicians--than we had 10 
years ago. We need to rebuild that workforce. And Secretary Tom 
Vilsack certainly recognized that, and, in the President's 
budget request for FY 2017, there is a proposed $30 million 
increase for animal health emergency response because we 
realized just how lucky we were to get on top of avian 
influenza after all of the damage that it did do.
    Mr. Chairman, this concludes my testimony, and I appreciate 
the opportunity to be here. I would certainly be happy to 
answer any questions.
    Chairman Johnson. Thank you, Mr. Shea.
    Our next witness is Dr. Aaron Firoved. He is the Director 
for the National Biosurveillance Integration Center (NBIC) in 
the Office of Health Affairs (OHA) at the Department of 
Homeland Security (DHS). He previously served as the Senior 
Biodefense Advisor to the Assistant Secretary for Health 
Affairs and Chief Medical Officer (CMO) of the Department.
    Dr. Firoved?

  TESTIMONY OF AARON M. FIROVED, PH.D.,\1\ DIRECTOR, NATIONAL 
 BIOSURVEILLANCE INTEGRATION CENTER, OFFICE OF HEALTH AFFAIRS, 
              U.S. DEPARTMENT OF HOMELAND SECURITY

    Mr. Firoved. Sir, we have generations of people being 
called ``Firewood'' in my family. [Laughter.]
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Firoved appears in the Appendix 
on page 77.
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    Chairman Johnson, Ranking Member Carper, and distinguished 
Members of this Committee, I want to thank you for inviting me 
to speak with you today. I appreciate the opportunity to 
testify on the Department of Homeland Security's role in 
biodefense, and it is an honor to sit beside my colleagues from 
HHS, the U.S. Department of Agriculture, and the Government 
Accountability Office (GAO). As you mentioned, I am the 
Director of the National Biosurveillance Integration Center. I 
am a microbiologist by training. I have done some work with 
anthrax at the NIH. And, I understood biodefense policy through 
service to this Committee, so I want to thank you. These 
experiences have given me a broad understanding of the 
biological threat to our homeland and a strong commitment to 
help improve our Nation's biodefense and progress.
    The threats and risks posed by emerging infectious diseases 
and the use of biological agents by terrorist organizations, 
violent extremists, and rogue States will continue to challenge 
our ability to warn, prepare, and protect the homeland.
    In the wake of these threats, the Department of Homeland 
Security remains fully engaged and proactive in characterizing 
the threat, providing warning of emerging and imminent 
diseases, and ensuring that the critical missions of the 
Department will continue, unabated, should a biological event 
occur.
    For example, during our recent Ebola virus disease outbreak 
in West Africa, DHS provided intelligence analysis to the 
interagency, State and local governments, and first responders. 
We directed research to better characterize the threat of Ebola 
persistence and fill gaps in public health and operational 
responses. And, we coordinated and implemented the enhanced 
screening for more than 42,000 international passengers at 5 
airports.
    Today, we continue to build upon these lessons learned from 
the responses to Ebola and apply them to other biological 
threats, as we tackle the emergence or reemergence of viruses 
like Zika, where we are ensuring that our partners continue to 
have timely information, our workforce is informed of 
protective measures, and the health interests of detainees in 
our care and custody is provided for. We must remain vigilant 
and innovative as biological threats continue to evolve and as 
new threats emerge.
    The DHS Office of Health Affairs coordinates the 
Department's biodefense activities to understand and meet these 
threats, today, and to be ready for the threats that will 
emerge, tomorrow. OHA synthesizes biological threat information 
from multiple sources and takes a true ``One Health'' approach 
to biodefense and emergency response.
    For large-scale biological events, having knowledge as 
quickly as possible allows for informed decisions that can save 
American lives. And to this end, the Department's operational 
biodetection and biosurveillance programs are critical to our 
Nation's biodefense.
    The National Biosurveillance Integration Center is uniquely 
situated within DHS to provide a fusion of human health, animal 
health, and environmental data to ensure our Nation's 
decisionmakers have timely, accurate, and actionable 
information.
    To accomplish this, we monitor thousands of data sources 
and leverage the expertise of 14 Federal departments and 
agencies, who are members of our charter--including those that 
you see at this table here--and then integrate this array of 
information into reports on biological incidents that could 
potentially cause economic damage, social disruption, or loss 
of life.
    Reports by my good colleagues at GAO and the Blue Ribbon 
Study Panel on Biodefense have acknowledged the progress that 
NBIC has made in delivering daily situational awareness to our 
partners, but we still have a lot of work to do to fully 
realize the vision that this Committee helped to start with 
comprehensive biosurveillance integration.
    To address this, we are developing new collaboration tools, 
pursuing innovative data sources and methods, and fostering 
greater stakeholder engagement.
    DHS's BioWatch Program provides Federal, State, and local 
leaders with actionable information on detection of a 
biological agent to enable a coordinated and effective 
response. One important and frequently overlooked benefit of 
our BioWatch Program is how we work with each local 
jurisdiction to ensure that the decisionmakers are familiar 
with how the coordinated response will unfold should the 
detection of one of these agents occur. There is no other 
program that provides this layer of biological defense.
    The DHS Science and Technology Directorate (S&T) is 
currently collaborating with OHA on enhancements to the 
BioWatch Program that will shorten the time needed to detect 
biological agents as well as address other short-term and long-
term capability needs.
    One of our most critical roles is in the integration of 
local public health with emergency management, law enforcement, 
and intelligence community (IC) partners--and their preparation 
and response to biological events. One initiative we are 
developing in coordination with HHS is the ``First Responder 
Vaccine Initiative.'' We are evaluating the feasibility of a 
voluntary pre-event anthrax vaccination program for first 
responders using the anthrax vaccine scheduled to rotate out of 
CDC's Strategic National Stockpile. I want to thank this 
Committee for moving on S. 1915, Senator Ayotte's legislation 
authorizing this pilot program.
    I thank you for your time, and I look forward to answering 
your questions.
    Chairman Johnson. Thank you, Doctor.
    Our final witness is Chris Currie. Mr. Currie is the 
Director of Homeland Security and Justice at the Government 
Accountability Office, where he leads the agency's work in 
evaluating emergency management, national preparedness, and 
critical infrastructure protection issues. In this role, Mr. 
Currie has led the reviews of numerous Federal programs as well 
as efforts to prevent, plan for, and respond to natural and 
manmade disasters and terrorist attacks. Mr. Currie.

   TESTIMONY OF CHRISTOPHER P. CURRIE,\1\ DIRECTOR, HOMELAND 
  SECURITY AND JUSTICE, U.S. GOVERNMENT ACCOUNTABILITY OFFICE

    Mr. Currie. Thank you, Chairman Johnson, Ranking Member 
Carper, and other Members of the Committee who are here today. 
I really appreciate the opportunity to be here, and, today, I 
would like to talk about GAO's work on biodefense.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Currie appears in the Appendix on 
page 82.
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    Defending the United States from naturally occurring or 
manmade biological events is a massive and difficult effort. 
Leadership and coordination are critical to such a large and 
fragmented effort, not only at the Federal level, but across 
levels of government and the private sector. The number of 
Federal departments at this table today, alone, demonstrates 
this point.
    In a hearing last fall, your Committee heard the findings 
and recommendations of the Blue Ribbon Study Panel on 
Biodefense. Our work through the years has come to many similar 
conclusions and recommendations. Today, I would like to talk 
about this work--ranging from coordinating the entire 
biodefense enterprise down to improving various specific 
programs.
    At the highest level, the Blue Ribbon Study Panel on 
Biodefense concluded that there is no central leader, no 
comprehensive national strategic plan, and no all-inclusive 
dedicated budget for biodefense. Our work has also found that 
there is no national strategy or single focal point for 
biodefense.
    As an illustration, there are over two dozen Presidentially 
appointed officials with biodefense roles. Over 5 years ago, we 
recommended that the Homeland Security Council within the White 
House develop a strategy and designate a focal point for 
coordination.
    They did issue a strategy in 2012 for biosurveillance and 
designated offices within the White House as focal points--and 
this is progress and it shows a commitment to coordinating 
biodefense efforts. However, it just does not go far enough.
    The biosurveillance strategy does not identify resource and 
investment needs, which is critical to help prioritize 
resources across such a complex enterprise. We have heard that 
the National Security staff created a more specific 
implementation plan of the strategy. However, we do not know 
the extent to which it is actually being used across government 
and across these departments. Thus, we do not know if it will 
operationalize coordination and prioritization of resources, as 
we think it should.
    We have also identified challenges with specific agency 
biodefense programs, such as those within DHS. Our report last 
October found that 12 years after the BioWatch program was 
first deployed, there is still not reliable information about 
its capabilities. This is because it was put in the field so 
quickly without performance requirements.
    We have also found that, because BioWatch was not fully 
tested, its uncertainties and limitations are unknown. We 
recommended that DHS not pursue upgrades until it establishes 
system performance requirements and tests against those.
    I would also like to talk about our work on the National 
Biosurveillance Integration Center--also within DHS. NBIC was 
set up, in law, to be the integrator, analyzer, and innovator 
of biosurveillance information across the entire Federal 
Government. However, it has never fully met this bar. NBIC has 
implemented our recommendations to strengthen collaboration 
within its partners, like CDC, HHS, and USDA. However, we 
reported last year that persistent challenges still get in the 
way.
    For example, most of its primary Federal partners--those 
like CDC and HHS--told us that NBIC's products and activities 
did not add value, did not provide new meaning, or did not help 
them identify biological events quicker. NBIC also still has 
difficulty getting the data it needs because partners either 
will not share it or there are restrictions to sharing that 
data.
    The challenges that NBIC faces are not easy to address by 
DHS, alone. We have identified options for policy or structural 
changes to help NBIC better fulfill its mission. However, these 
options may require changes in law--and it is not clear that 
even these would address the challenge.
    This brings me back to the bigger issue. As we and the Blue 
Ribbon Study Panel on Biodefense have noted, investments in 
specific programs should be evaluated in terms of cost and 
benefit, but they should also be prioritized against other 
programs across government as part of a national biodefense 
strategy.
    Another critical part of this prioritization should be 
using the most recent threat and risk information to guide 
decisions. This is implemented to ensure that our limited 
resources are directed to the most important areas. Without a 
strategy that bridges across departments, it is difficult for 
decision-makers in Congress and those in the executive branch 
to make resource decisions above the traditional agency-by-
agency approach.
    This concludes my prepared remarks. I would be happy to 
answer your questions.
    Chairman Johnson. Thank you, Mr. Currie.
    I want to kind of go back to this within the specific 
agencies to get just sort of an update on exactly where we are. 
I want to start with the USDA. Mr. Shea, the last avian 
outbreak occurred between December and June, and that was 
basically migratory birds flying south, correct?
    Mr. Shea. Correct.
    Chairman Johnson. But, obviously, in June, they are also 
flying back. I just kind of want to get to--to what extent have 
we dodged this bullet? Have we gone through now, basically, 2 
additional migratory patterns without this hitting us again?
    Mr. Shea. Mr. Chairman, it is still too soon to say. What 
ended up being the final end to the outbreak last year really 
was due to the onset of warm weather. Once the temperatures get 
consistently above 70 degrees, the virus pretty much will not 
survive.
    Chairman Johnson. Very similar to human flu, then.
    Mr. Shea. Yes.
    Chairman Johnson. OK. So we were kind of getting it coming 
and going then--migratory birds coming up, coming back--but 
then temperatures got to a certain point, and that outbreak 
ended.
    Mr. Shea. Exactly. And also, what happens with the 
migratory birds, when they are flying south, they pretty much 
have a clear path. They just keep going. When they are heading 
north, they can slow down. For example, what happened last 
year--and the reason we thought it was so bad in Iowa and 
Wisconsin--was that the birds were heading north, but the 
weather was still too cold. They got to a spot where the lakes 
were still frozen and hung out.
    Chairman Johnson. I live on one of those lakes, so, yes, 
OK, I got it. So, that is pretty good news, though.
    Now, the outbreak in Indiana--is that typical, where we 
just on occasion see these small, little outbreaks and stuff 
and we can respond quickly? Or is that----
    Mr. Shea. It is typical to find low-pathogenic avian 
influenza outbreaks. They happen from time to time. What we 
believe happened here was probably a low-pathogenic virus that 
may have mutated on just the one farm. The local surrounding 
area where we had 9 or 10 other infected premises were all low-
pathogenic.
    Chairman Johnson. OK. But, again, that was probably 
spreading out by migratory birds. That was just spread within 
that localized flock, hopefully.
    Mr. Shea. It may have started with a migratory bird, but 
have spread as you suggest.
    Chairman Johnson. OK. I want to kind of revisit Ebola. I 
will go to Dr. Firoved. Has that been totally wiped out? Has 
that been completely contained? Are there any active cases 
right now in Africa that we are aware of?
    Mr. Firoved. Unfortunately, we have seen cases reemerge in 
Guinea and Liberia. So, I will defer to my colleague from the 
CDC, but, there is some active tracing going on.
    Chairman Johnson. Dr. Redd, tell me what happened there. 
Did we get to a level of zero and it is just coming back, or 
what?
    Dr. Redd. So, the widespread transmission that was seen in 
2014 and 2015 has been contained. What we have seen, 
repeatedly, in Liberia, Sierra Leone, and now, in Guinea, are 
very small clusters, identified after a few cases--with very 
rapid response, and by implementing the measures that brought 
the disease under control when it was more widespread. 
Unfortunately, this is not unexpected. The latest case we 
believe is from sexual transmission. A person that had Ebola in 
the past transmitted that disease through the route of sexual 
transmission, and then a small cluster occurred. And, I think 
that this outbreak is now being worked on very hard, both in 
Guinea and in Liberia--and those cases in Liberia are connected 
to the ones in Guinea.
    The thing that is different now is that the response is 
very vigorous. Large numbers of contacts are being identified 
and traced to be sure that, if one of those people does become 
sick, they will be put into isolation and given treatment very 
quickly.
    Chairman Johnson. Because of the tragedy that occurred 
there, is the general population far more educated on this as 
well as--in addition to the public health and safety officials 
who know how to respond? Is it a combination of that, or is it 
primarily--tell me what worked. What lessons have we learned?
    Dr. Redd. Well, I think, to go back to the lessons, the 
situation that is occurring right now is not that different 
than what occurred in March through April 2014, in terms of 
where the disease is occurring and the location. The thing that 
is different is that we have a much more vigorous response--so, 
both in Guinea and in Liberia, there is the capacity to 
identify those cases quickly and respond, and there is an 
international presence that is able to respond.
    And, to go back to 2014, the things that did not happen 
that needed to happen concerned the ability of those 
governments to rapidly identify cases, to respond effectively 
to them, to call for help when the response was not going well, 
as well as for the international community to be able to 
respond. That is basically the structure of the Global Health 
Security Agenda (GHSA) which is being implemented in those 
countries and in other countries in Africa, Asia, and the 
Americas.
    Chairman Johnson. So, again, you are basically describing 
real progress, in terms of public health and the work of safety 
officials. Has there been any progress just in terms of 
information to the general population where these things--let 
us face it, Ebola breaks out in these African countries.
    Dr. Redd. I think that there has been, and I think that, 
particularly, at that inflection point, depending on the 
country, in 2014 and 2015, it is likely that a lot of the 
control was actually implemented outside of official channels, 
that communities understood the risk that Ebola caused and took 
measures into their own hands, in terms of isolation 
facilities, local care, etc.
    I think this is actually a really important question that 
we need to have better hard data on, but it appears that that 
was an important part of the response--in addition to the 
community mobilization and communication efforts that took 
place.
    Chairman Johnson. I hate that I am going to ask this, but--
what was the final mortality rate? How many people were really 
affected? Because, when this first broke out, we were 
projecting literally a few months from then there being a 
million people.
    Dr. Redd. Yes, sir.
    Chairman Johnson. So, how did we finally contain this?
    Dr. Redd. It did not reach a million people, and that 
estimate of a million people was in the absence of any control 
measures. So, I think in some ways, even though the number was 
massive, it was not what----
    Chairman Johnson. It did not hurt to get the public's 
attention so we could respond. We ended up with tens of 
thousands?
    Dr. Redd. Tens of thousands of cases and 10,000 or so 
deaths. And, just for context, the total number of cases, in 
all of the outbreaks up to that point, was around 2,500. So, 
around 10 times more cases than had ever occurred, and one of 
the things--just thinking about the sexual transmission side of 
it--we probably have twice as many male survivors as there were 
total cases before this outbreak.
    Chairman Johnson. Is that pretty unusual? I mean, was that 
because of additional treatment? Hydration? So, how many people 
were infected? How many people died? What was the survival 
rate?
    Dr. Redd. Yes, I mean, I can give you the exact number from 
reports.
    Chairman Johnson. I just looked at----
    Dr. Redd. But, 25,000. And, 12,000 deaths--something like 
that.
    Chairman Johnson. From how many people infected?
    Dr. Redd. 25,000. So, about a 50-percent mortality rate, 
overall. And, when I give those numbers, I have to say that the 
quality of that information, particularly early in the outbreak 
when medical services were overrun--many deaths occurring in 
the community----
    Chairman Johnson. I understand. I am just trying to get 
some sense----
    Dr. Redd. Just in order of magnitude.
    Chairman Johnson. Where are we at, in terms of the 
development of a vaccine? Because Ebola has been around. We 
were working on a vaccine. It just was not really a top 
priority. I would imagine it has become a priority. Are we 
making progress, in terms of a vaccine?
    Dr. Redd. Yes, sir. I will answer that question, 
specifically, and then I will turn to my colleague from BARDA. 
A vaccine is actually being used now to control the outbreak in 
Guinea and Liberia. There were 3 clinical trials of different 
vaccines that were undertaken. The ones in Liberia and Sierra 
Leone, the vaccine got there after the disease was on the down 
trend, so they were not able to show effectiveness. They were 
able to measure the safety of the vaccine. A trial conducted in 
Guinea using a different strategy to use the vaccine and to 
measure its effectiveness did find the vaccine to be 
effective--and this was a containment strategy where a case was 
identified and then the cluster of contacts and the contacts of 
the contacts were vaccinated to prevent onward transmission. 
And, that study did show effectiveness.
    Chairman Johnson. So, what level of effectiveness? I 
realize it is just a ballpark, but, I mean----
    Dr. Redd. Yes, I would have to get back to you----
    Chairman Johnson. Was it pretty darn effective?
    Dr. Redd [continuing]. On the exact number. I think that 
there are some questions about whether a person was exposed or 
not. It was not shown to be effective--or it was not tested to 
be effective before the period of 6 days after exposure. So, 
after that period of time, it did demonstrate effectiveness. I 
can come back to you with the exact number on that.
    Chairman Johnson. OK.
    I actually have the luxury, because I am here by myself, to 
keep asking questions.
    Did we ever get to the bottom of the infection of those 
nurses in Texas? We were, again, assuming that we kind of had 
this understood and we were going to take precautions--and yet, 
we still had----
    Dr. Redd. Yes, sir. Well----
    Chairman Johnson. So, did we ever solve that mystery, in 
terms of how those nurses got----
    Dr. Redd. I am not sure we totally solved it. What we did 
do was put in place a different plan for personal protective 
equipment, which included very specific guidance on what types 
of protective equipment were needed and also put in place a 
strategy to train people to use that personal protective 
equipment before needing it. Then, there was the additional 
specificity of, when a person is being treated for Ebola, 
including things like observers to make sure that a person does 
not accidentally, when they are taking the equipment off--kind 
of a risk period--that something did not happen. And then, also 
following those individuals after the person was gone. Similar 
to the returning travelers that Dr. Firoved mentioned--tracking 
them daily until the potential incubation period was over.
    Chairman Johnson. So, from the start of that outbreak to 
kind of the final conclusion of it, it seems like, certainly, 
the procedure was, ``We can handle this in hospitals to the 
point where now let us do it in very specialized hospitals.'' 
Is that kind of the process and procedure in place now, that we 
are going to have basically ``Centers of Excellence'' here, 
and, hospitals are going to have to be ready, because they 
would have to respond properly--but then transport individuals 
that proved positive?
    Dr. Redd. So, for Ebola that is the system that is in 
place. I think a lot of the discussion is about other diseases 
that there might be more cases of and trying to adapt that 
system, so that we have the right care for people who have 
these very severe effects. I think I would pass it to Dr. 
Hatchett.
    Chairman Johnson. And, by the way, Ebola is obviously a 
unique disease, but the procedures in place, those are good 
procedures for a number of types of situations?
    Dr. Redd. Yes, sir. I think there are a couple of 
characteristics about Ebola that are different, and that 
probably is, primarily, the small number of cases and the need 
for the very rigorous infection control procedures. If there 
were a large number of cases, the system that we have in place 
would have to be changed.
    Chairman Johnson. Right. It would be overwhelmed.
    Dr. Redd. We are sort of in the kind of dozens of cases 
level of capability.
    Chairman Johnson. Dr. Hatchett, can you kind of speak to 
the progress of the vaccine--and, obviously, the 
effectiveness--but also to our ability to produce it?
    Dr. Hatchett. Of course. Would you like me to touch on the 
Ebola treatment centers?
    Chairman Johnson. Sure.
    Dr. Hatchett. So, just to answer that question and then to 
go back to the vaccine question, through ASPR's Hospital 
Preparedness Program, with the assistance of the funding that 
was provided by Congress in the Ebola supplemental, we have 
established a tiered system, nationally, of Ebola treatment 
centers. There are now 9 regional Ebola treatment centers. 
There are 3 education and training centers at the pinnacle of 
that system, and then there is a system of feeding hospitals--I 
believe the number is 73--State or local Ebola treatment 
centers that can manage patients, temporarily, before they can 
be transferred to the 9 centers that are fully equipped. And 
then, there is a larger system of assessment hospitals. I 
believe the number is over 200, nationally.
    Chairman Johnson. OK. Thank you.
    I have to go vote. I am going to turn it over to Senator 
Carper. Hopefully, I can get back here, and we can kind of 
follow up.
    Dr. Hatchett. I will talk about the vaccine.
    Senator Carper [presiding.] Mr. Currie, unfortunately, I 
had to leave as soon as you started to speak--and it was not 
cause and effect, but we trade off like this. We usually have 
15 minutes in which we can vote, so this way we can keep things 
rolling and not unduly delay you. But, just take a minute and 
give me 
the--over in the House of Representatives, people give 1-minute 
speeches, and so, I will ask you to give us your best 1-minute 
speech, please.
    Mr. Currie. I will do my best, sir. So, I think from my 
oral statement, there were 2 big areas I wanted to focus on. 
First, was what I called the 60,000-foot level, the 
coordination across the biodefense enterprise. And then, the 
second piece was looking at some of the specific programs at 
DHS that we have looked at. Of course, we have done a lot of 
work at HHS and USDA as well.
    But, let me focus on the 60,000-foot level. I think a 
problem that we have identified through the years--and so has 
the Blue Ribbon Study Panel on Biodefense--is the lack of a 
unified strategy at the top--at the Federal level--to guide all 
of the departmental efforts and resources. And, all of the 
departments work really hard and do a very good job of doing 
their individual missions. The problem is, there is nobody 
above that has the authority or the ability to actually drive 
resource decisions and priorities. And so, that makes it very 
difficult to know if we are addressing the top priorities. And 
so, that was a key point from my opening statement.
    Senator Carper. All right. As you know, we talked a little 
bit--I mentioned the Blue Ribbon Study Panel on Biodefense co-
led by Joe Lieberman and Tom Ridge. And, one of their 
recommendations spoke--or at least attempted to speak to the 
point you have just made. Let me just ask all of you, with 
respect to the recommendations--I think they made 33 
recommendations, and a major recommendation was that the Vice 
President should be sort of the person to lead this. What 
current and planned activities are each of you taking, or 
planning to take, to address the recommendations contained in 
the report? What do you think about the recommendations for the 
Vice President, in this case, Joe Biden, leading this effort 
for the next 9 months and then, presumably, whoever succeeds 
him leading afterwards?
    Mr. Currie. I can start.
    Senator Carper. Yes, please.
    Mr. Currie. We have not taken a formal position on whether 
the Vice President's Office is the right place to place that 
responsibility or not. But, we understand why the Blue Ribbon 
Study Panel on Biodefense made the recommendation that the Vice 
President serve that role, because it needs to be somebody in a 
position of authority that can guide all of the Federal 
departments, each with their own powers and responsibilities, 
to do things and spend money a certain way.
    We made our initial recommendations along those lines to 
the National Security staff within the White House, and so I 
think--and our goal there was, again, to try to put it at a 
level that was above the departmental level.
    So far, I think we have been a little underwhelmed at the 
efforts that have come out of the response to that 
recommendation. There have been some strategies developed. The 
problem is that, even within those offices, they still have 
trouble dictating exactly what the other Federal departments 
are doing.
    So, I am not sure what the right entity is, but I think the 
problem is consistent across our work and the Panel's work.
    Senator Carper. All right. Thank you. Thank you very much.
    Others, please? Dr. Hatchett, what current or planned 
activities are you all taking, or planning to take, to address 
the recommendations contained in the report?
    Dr. Hatchett. Thank you, Senator, for the question. We 
certainly participated in the process that led to the 
development of the report. We participated in the meetings. We 
read the report, with interest, when it came out. We feel that 
we have actually undertaken activities that address or parallel 
some of the recommendations in the report. I just mentioned the 
establishment of the Ebola treatment centers and the national 
hospital system for managing diseases that require high 
containment--that, in some ways, is similar to a recommendation 
within the report.
    We are not responding directly to the report, but we 
certainly feel that it has been a valuable contribution to the 
national discussion on this issue.
    Senator Carper. What do you think of the point of Mr. 
Currie--the point that the Blue Ribbon Study Panel on 
Biodefense recommended the Vice President be anointed to follow 
up and implement the recommendations of the report? If not the 
Vice President, how about the junior Senator from, maybe, New 
Jersey? [Laughter.]
    He does not have much going on now. He has finished his 
book and he has finished his book tour. He is looking for stuff 
to work on. No, I am just kidding.
    Dr. Hatchett. So, we feel that we have effective cross-
government mechanisms in place, already, to ensure that threats 
can be identified and responded to appropriately within the 
statutory sphere of the Assistant Secretary for Preparedness 
and Response, which is public health and medical preparedness 
and response. We actually have mechanisms in place which reduce 
the need for a central oversight figure. We have two very 
effective coordinating bodies that are interagency bodies where 
we work with our colleagues at the CDC, the FDA, the Department 
of Defense (DOD), etc.
    The first of these is the Disaster Leadership Group, which 
the Assistant Secretary for Preparedness and Response convenes 
and which responds to complicated emergencies. That addresses 
policy issues that will arise. In recent months, for example, 
we have convened two different Disaster Leadership Groups--one 
to address the Flint, Michigan water crisis and another to 
address the emerging Zika crisis.
    Within the domain of medical countermeasures, we have a 
very effective coordinating body, the Public Health Emergency 
Medical Countermeasures Enterprise. In my oral testimony, I 
cited some of the successes that we have demonstrated. That 
entity has really evolved----
    Senator Carper. I am going to ask you to hold it right 
there. Otherwise, these guys will never have a chance to say a 
word. Dr. Redd.
    Dr. Redd. There are a number of recommendations that 
pertain specifically to the CDC. I could go through those now 
or we could submit written answers to that.
    Just quickly, recommendation 15 is a collaboration with the 
Department of Homeland Security on anthrax vaccination. We are 
providing the vaccine for that pilot--or would if the pilot 
started--from the Strategic National Stockpile. There is a 
recommendation to develop and implement a medical 
countermeasure response framework. We actually are working with 
State partners through the Public Health Emergency Medical 
Countermeasure Enterprise to implement improvements on the 
distribution and dispensing of the stockpile.
    There is a recommendation to allow for forward deployment 
of SNS assets. That was number 23.
    We are working closely with New York City on really kind of 
a project management formula that--when they are ready to 
administer product from the stockpile--we get it there that 
quickly--so, matching the delivery from the stockpile to the 
local capacity. And, we will be working with other health 
jurisdictions to marry their capability and our capability.
    There is a recommendation to overhaul the Select Agent 
program. I think that would kind of fall into the overall 
category of a high-level policy decision. We are doing a lot of 
work to improve the Select Agent program within our authority, 
improving the inspection process, the process to report 
incidents that are identified at the facilities, and the 
communication and transparency aspects of that.
    There actually have been 3 recent----
    Senator Carper. Dr. Redd, I am going to ask you just to 
hold it right there. What I think I am going to ask you is, for 
each answer for the record, give us the status of your 
implementation--those that you have begun implementation on, 
those that you have completed implementation on, and those you 
have no intention of implementing. And, you can also use that 
as an opportunity to respond as to whether or not you think the 
Vice President is the better person to oversee the 
implementation as opposed to Senator Booker, who I suggested as 
a possibility. When he asks his questions, maybe he can cast 
some light on it.
    But, just raise your hands. How many of you think that we 
need somebody like the Vice President who can sort of oversee 
the implementation that--without that, we are not going to make 
the kind of progress we otherwise would need? How many think 
that? If you do, raise your hand.
    [No response.]
    And, if you do not, raise your hand.
    [All hands raised.]
    All right. Thank you.
    Let the record show Booker: 2 and Joe Biden: 0. But, I saw 
there were several people leaning toward Joe as well. All 
right. Senator Booker.

              OPENING STATEMENT OF SENATOR BOOKER

    Senator Booker. I have lost many votes before. This is one 
that I am very happy to not win, if possible. So, I want to 
thank you very much for holding this. I think this is an urgent 
hearing and there are a lot of very consequential realities at 
stake. And, I want to thank the folks before me because your 
dedication to the health, strategy, strength, and security of 
our country is really admirable.
    I have some very New Jersey-based concerns--and, perhaps, I 
could start with Dr. Hatchett on the end. So, a lot of the 
dollars that are received through our State for homeland 
security issues are based upon formulas. The Hospital 
Preparedness Program is a program that, recently, New Jersey 
has seen a significant cut to.
    Now, it is a little incongruous to me because, in the risk 
profiles, which are calculated by the Department of Homeland 
Security, we have actually seen increases in some areas. For 
example, in fiscal year 2016, the Department of Homeland 
Security recognized New Jersey's vulnerability to a targeted 
violent attack and heightened the State's risk score to 
``threat.'' DHS also raised our Urban Area Security Initiative 
(UASI) grants--UASI vulnerability, moving it from 11 to 7 on 
the risk index. So, we see that New Jersey, when it comes to 
risks--terrorist attacks, bioattacks, and the like--is getting 
more severe, but yet, at the same time, somehow, in the 
formula, we are being cut from the HPP program.
    And so, I am just wondering what the reason for the cut is, 
given that the Department of Homeland Security sees us--and you 
understand that New Jersey is--I live 10 miles from Manhattan. 
In fact, Manhattan is moving their back offices and a lot of 
their infrastructure to New Jersey, which, again, DHS sees as 
heightening our risk.
    And so, I am wondering, is this, in your opinion, 
problematic? Is it incongruent, as I see it? Or, do you see it 
in a different way?
    Dr. Hatchett. So, I cannot speak to the particular case of 
the New Jersey allocation, but I can say that the Urban Area 
Security Initiative risk scores are figured into the Hospital 
Preparedness Program formula. And, that formula and those 
allocations are reviewed annually, and so they are adjusted 
annually.
    There are many factors other than risk score which go into 
the formula--certainly population, etc. Given that I am not, 
myself, personally responsible for the Hospital Preparedness 
Program, we can certainly get back to you with a more detailed 
response.
    Senator Booker. Yes, I would really appreciate that--and, 
maybe, we can even meet on it, because if it is population, New 
Jersey is the most densely populated State in America. If it is 
critical infrastructure, we have the most dangerous, they say, 
couple of miles--there are chemical companies, you name it. I 
just do not understand how we could be going down, especially 
when other areas of the Federal Government are seeing us as 
being at a higher and higher risk for these problems. So, I 
would really appreciate it.
    Dr. Hatchett. Yes, sir. We would be glad to do that.
    Senator Booker. Thank you. Thank you very much.
    Let me go really quickly over just some of my concerns, in 
general, about Zika and some of the other elements.
    Dr. Redd, can you explain to me the process for the New 
Jersey Public Health Emergency Preparedness Program, the PHEP 
Program--the award was increased this year. However, because 
the CDC is looking at additional money to allocate for Zika, we 
have seen money being taken away from the States, including New 
Jersey, which raises concerns, for me, that we are just moving 
around a finite pool that has urgent needs, as opposed to 
allocating new money, and that that might be weakening our 
preparedness. So, can you explain to me the process for cuts? 
And, were they just sort of blunt cuts across the board or 
really are we looking at the crises and the concerns for safety 
and security?
    Dr. Redd. Let me start by saying that I agree with your 
underlying point, which is that this is a new threat and we 
need the supplemental appropriation to be passed--and that 
would address the problem in the way that it needs to be 
addressed.
    Senator Booker. That is a very profound statement that I 
want to repeat one more time. You agree that this is a new 
threat and that we should be making supplemental new funding, 
as opposed to taking away urgently needed dollars from 
currently existing programs?
    Dr. Redd. Yes, sir.
    Senator Booker. Thank you for that.
    Dr. Redd. We completely agree with that.
    Senator Booker. That is definitely an important statement. 
Thank you.
    Dr. Redd. So, in the absence of that, there is a very 
difficult decision that the Administration had to make as to 
whether we would respond to the current threat or not--and the 
only way to respond to the current threat was to identify funds 
that could be used now. I think your description of a blunt 
instrument is correct--that there was an across-the-board cut 
to the Public Health Emergency Preparedness Program. It was a 
little complicated as to how each dollar amount was arrived at 
for every grantee, but every grantee lost funding.
    Senator Booker. OK. But, there is obviously a better way to 
do it. Can you speak to me a little bit about--and maybe some 
other people might want to chime in. We seem to often be very 
reactive to crises. Do we have some kind of predictive 
analytics to better know what is coming before it dominates the 
headlines and fear is being--could we be doing a better job 
heading some of these crises off?
    Dr. Redd. I think that is a very big challenge and I think 
it is one that we continue to work on.
    To take the particular case of Zika, there are many aspects 
of this that are unprecedented. It has been 50 years since an 
infectious disease has been identified as the cause of a birth 
defect. There has never been a birth defect caused by an 
infection transmitted by a mosquito. So, if we were to use the 
historical record, this is not something that we would have 
predicted. I think that there is a need to be able to forecast 
more effectively than we have been able to do.
    A totally different problem than with Ebola--although the 
event that occurred in West Africa was also not predicted. I 
think that for that event, had we had in place the systems that 
are being put in place now, we would not have had the event 
that we had. We might have had something that is similar to 
what we are seeing now with a very rapid detection and response 
to a problem.
    Senator Booker. OK. I am going to submit one more question 
for the record because I have to go, but it is more about just 
general preparedness. I like the idea, as was said in the 
testimony, that preparedness is not an event--it is an ongoing 
process. But, I do worry about the States--having run a lot of 
tabletops for a lot of things, I worry about our overall State 
and Federal working coordination and preparation for a lot of 
the problems that I think are going to be seen more and more--
not just here in the United States, but also threats coming 
from overseas.
    Thank you.
    Senator Carper. Thank you so much, Senator Booker. Senator 
Peters.

              OPENING STATEMENT OF SENATOR PETERS

    Senator Peters. Thank you, Senator Carper. And, thank you 
to our panelists for your testimony here today. I certainly 
concur with my colleagues. We appreciate you being vigilant and 
on the job each and every day. These are serious threats, and 
we appreciate your dedication to it.
    In addition to being on HSGAC here, I also serve on the 
Commerce Committee. And, I am currently the Ranking Member on 
the Space, Science, and Competitiveness Subcommittee. I am 
currently working with Senator Cory Gardner on a working group 
that is going to be reauthorizing the America Competes Act. 
And, from my perspective, if we are going to increase our 
biodefense preparedness and work to counter diseases which can 
pose a threat--either intentionally or naturally--we need to 
fund basic scientific research and consider it both a national 
and, really, a homeland security priority for us.
    Last year, in a hearing examining the Blue Ribbon Study 
Panel on Biodefense, this Committee heard that that report 
found that federally funded scientific investigators are more 
likely to engage in early-stage research, versus in the private 
sector, where the focus is on specific product goals and end-
user needs--and that this was a cause for Ebola medical 
countermeasures not being available when they were needed.
    When looking at the America Competes Act, the working group 
examined global biomedical research funding trends and found 
that private investment in the United States correlates very 
closely with government investment. When government investment 
in research and development (R&D) shrinks or it stagnates, the 
private sector pulls back as well. And, when government grows 
its investment, the private sector tends to follow suit. And 
yet, Federal R&D spending has fallen below 1 percent of GDP, 
which I believe is unacceptable for our future and R&D is 
important for biodefense as well as the seed corn for 
innovation.
    So, given the correlation between Federal and private 
sector investment in basic science, I am a big supporter of 
robust Federal funding for basic research and believe that 
research can certainly contribute to the next big thing--
whatever that next big thing is. It also sparks new industries, 
creates jobs, and builds the economy, but, as we are discussing 
today, I think it also improves our biodefense preparedness as 
well. So, the challenge is in deciding the right ratio of basic 
to applied research--and appropriate funding levels for each--
and the proper role of the private and public sectors.
    So, first, to Dr. Hatchett and Dr. Redd, could you explain 
how your agencies make use of basic science research, kind of 
your sense of where we are, where our needs are, and what you 
would like to see?
    Dr. Hatchett. Sure. Yes, thank you for that question. Just 
to be clear, I am the Acting Director of the Biomedical 
Advanced Research and Development Authority. As our name 
implies, we work in the area of advanced research and 
development. As we understand that term, it means when we are 
working on medical countermeasures. These are medical 
countermeasures that have reached the clinical stage of 
development, where many of the problems relate to the clinical 
testing of the product as well as to scaling up manufacturing 
and working out manufacturing issues, so that we can be able to 
produce the products on a large scale.
    We have to depend on our colleagues at the National 
Institutes of Health and the Department of Defense to fund that 
basic research. We do not fund basic research. And, it is very 
important for us to coordinate our efforts with them so that, 
as they cultivate products and bring products forward through 
the earlier stages of discovery and development, we are ready 
to transition those products to advanced development.
    In the case of the Ebola vaccines--and Ebola therapeutics, 
for that matter--Ebola obviously had been on our threat list 
for some time. It is one of the material threats that the 
Department of Homeland Security has identified. NIH and the 
Department of Defense had been supporting basic research on 
countermeasures and had been moving those countermeasures 
forward through the development cycle.
    When the Ebola epidemic started in 2014, none of those 
products had reached the stage where our organization was--that 
they were ready to be developed by our organization. Within a 
very short span of time, within about a year, we were able to 
transition 12 products from that preclinical development to 
advanced development--and many of those products have actually 
been tested in West Africa. So, we do have a strong system as 
it relates to biodefense for supporting product development and 
translating products from basic research--and I could not agree 
with you more about the importance of basic research.
    Senator Peters. Thank you. Dr. Redd.
    Dr. Redd. Yes, sir. If we had a panelist from NIH, you 
would have kind of a good description of the proportion of 
basic research and the proportion of applied research and 
practical application. So we do some basic research ourselves, 
but, predominantly, our mission is to protect the health of the 
public and to use the tools that are available to make sure 
they are effective and to make sure that they are disseminated. 
So, we are more on the end-user side of that spectrum from 
basic research to use.
    Senator Peters. I realize that, but, I guess, the follow-up 
question is: So do you believe that we need to be putting more 
into basic research, as these threats seem to be developing, 
and, in some ways, at an accelerating rate--that we are 
probably doing ourselves a disservice if we are not putting 
more resources into the very foundational level of science?
    Dr. Redd. I think we do. I think we also need to make sure 
that we do not have a bottleneck at that development stage and 
we are able to get things through the system quickly to find 
out if they are going to be useful in large populations and be 
effective. And, some of those kinds of questions are difficult 
or are not possible to answer at the basic level.
    Senator Peters. Right. Would any of the other panelists 
like to weigh in?
    Mr. Firoved. Sure. At the Department of Homeland Security, 
we have the Science and Technology Directorate, and it is 
critical to helping the Department meet the needs of its 
stakeholders--whether they are first responders--helping make 
improvements to the BioWatch program--and it relies on a 
diverse university program as well--the ``Centers of 
Excellence'' to help us meet those needs. And, just recently--
since we have been talking about Ebola--some basic 
understanding that has significant ramifications for biodefense 
have to be answered still. So, some of the questions were: How 
persistent is Ebola on surfaces? How long does it remain 
infectious? And so, in a study that was conducted with our 
partners, we were trying to understand what it does on the 
carpet of an airplane or on surfaces that our employees might 
encounter in an airport.
    And so, this kind of basic research has real, serious 
implications for our day-to-day operations--so it is critical.
    Senator Peters. Thank you. I appreciate it. Thank you very 
much.
    Senator Carper. Thank you, Senator Peters.
    Looking at the list of folks, Senators Ayotte and Tester 
were here when the gavel came down. They may come back. Next on 
the list is Senator Ernst. If we are looking for somebody who 
has previous military experience, a colonel--and maybe you 
could be next for us. Then, Ben Sasse, if he returns, and then 
Senator Portman and Senator McCaskill.

               OPENING STATEMENT OF SENATOR ERNST

    Senator Ernst. Thank you, Ranking Member. I appreciate it. 
And thank you, gentlemen, for being with us today.
    This question is for anyone on the panel, please. I want to 
follow up on a question that was asked earlier by Ranking 
Member Carper. One of the Blue Ribbon Study Panel on 
Biodefense's top recommendations was the development and 
implementation of a comprehensive national biodefense strategy. 
This Administration has failed to present a comprehensive 
strategy in a number of areas--whether it is defeating the 
Islamic State of Iraq and Syria (ISIS) or countering the use of 
social media--which has led to disparate efforts that lack 
focus. And, as the Blue Ribbon Study Panel on Biodefense 
concluded, the United States is underprepared for biological 
threats and it is critical that the Administration establish a 
comprehensive biodefense strategy.
    Could Mr. Currie or anyone else on the panel speak to the 
importance of this recommendation?
    Mr. Currie. Yes, ma'am. Absolutely, we think it is very 
important--and our findings and recommendations have been 
really similar to the Blue Ribbon Study Panel on Biodefense's 
findings and recommendations.
    I think it is important to note that it is not easy. Part 
of the reason it is so difficult to do this--and this links 
also to their recommendation of providing the Vice President 
the authority to do this--is because it has to come at a level 
that is above the cabinet and the Department level because 
Departments cannot tell other Departments what to do. It is 
very difficult to allocate resources between the Departments 
and identify resources priorities--for example, deciding that 
we want less resources in one Department's program versus more 
in another. And, that is exactly why such a global national 
strategy across the Federal Government is so important. But, it 
is very difficult to do.
    Senator Ernst. Yes, and we understand the difficulty, but 
also the importance and necessity of doing that.
    Would anyone else like to respond?
    Dr. Hatchett. Yes, ma'am. Thank you for the question. While 
the Office of the Assistant Secretary for Preparedness and 
Response has not developed a strategy for the parameters that 
are described in that report, I do think it is important to 
point out that they did leave the development of a National 
Health Security Strategy. The first National Health Security 
Strategy was completed in December 2009 and an updated version 
of the strategy was completed in December 2014.
    The National Health Security Strategy is a broader 
strategy. It does not just look at biodefense. It also focuses 
on securing the Nation's health security--as the title implies. 
It has 5 major strategic objectives. The first is to promote 
the development of resilient communities that are capable of 
responding to incidents of all kinds, including biodefense-
related threats. The second is to promote the development of a 
robust medical countermeasures enterprise. The third is to 
promote comprehensive health situational awareness, so that 
decisionmakers can respond appropriately. The fourth is to 
promote integration of public health, health care, and 
emergency management systems across the Nation at the different 
levels of government. And, the last strategic objective is to 
promote global health security, so that we can address issues 
like the Ebola epidemic.
    So, that is an overarching strategy that governs a great 
deal of what we do in biodefense. And, in developing that 
strategy, we did work with stakeholders at all levels of 
government and with our interagency partners.
    Senator Ernst. That is wonderful. Very good. Great first 
step.
    For Administrator Shea, thank you very much for being here. 
How do we integrate information about animal and human health 
without creating or perpetuating misunderstandings and fear 
among consumers, both here at home and abroad? We do see this, 
where, perhaps, the Chinese or other governments will push away 
any commodities, like produce that they feel might do them 
harm--or they can make that up. So, what are your thoughts on 
that?
    Mr. Shea. I think it is very important that we stick to the 
science and we work with our colleagues on the human health 
side to be clear about the science. And, a really good example 
of that, of course, that affected your State, was what was 
being called ``swine flu'' in about 2009, when we should have 
called it by its proper scientific name, ``novel influenza A 
(H1N1).'' And, it is so important to do that because the 
industry, which so important in Iowa, of course, was put at a 
real disadvantage because of the fear of an influenza that 
really should not have been attributed only to swine. So, that 
is why it is so important that the science be integrated and 
that we speak with science. And, that is why I think it is 
important that we have someone embedded at CDC--which we do--
and that we work, on a daily basis, to make sure those messages 
go back and forth.
    Senator Ernst. Very good. And, also, you spoke about the 
swine flu. We can talk a little bit about the avian flu, but, 
yes, go ahead, sir.
    Mr. Firoved. Thank you. I also wanted to point out that 
there are some robust communications that go on between these 
entities. Within our center, we actually also have a liaison 
with APHIS within the USDA, and it has proved to be critical 
for producing this ``One Health'' message. And, in one case 
just this last fall, we were seeing some erroneous news reports 
come up about a resurgence of avian influenza that just were 
not at all accurate. But, working through the National Wildlife 
Health Center (NWHC), also with the Department of Interior, as 
well as our colleague at APHIS with the USDA, we are really 
able to push through those agencies, able to tamp down these 
stories, and really able to prevent a story from gaining legs 
that could have economic consequences.
    And, so I think that the ``One Health'' approach is so 
critical to everything that we do--and we need to continue to 
bridge this divide.
    Senator Ernst. Great. Yes, sir?
    Dr. Redd. Just briefly--to support the Administrator here, 
we have a very intense scientific interchange with USDA on 
influenza and also for foodborne diseases. So, there are some 
pockets of just very close collaboration.
    Senator Ernst. Very good. Well, I appreciate that so much. 
And, we spoke about this earlier--or we heard about it 
earlier--but, as you know, last year the poultry sector was 
rocked by the Asian highly pathogenic avian influenza (HPAI), 
commonly called ``bird flu.'' And, this was very devastating in 
Iowa, where it resulted in the death of over 30 million birds 
and inflicted $1 billion of damage to our economy in Iowa. It 
was one of the worst foreign animal disease outbreaks in our 
Nation's history. And, the livestock sector is also regularly 
impacted by these diseases--and they struggle to control them--
with new ones popping up each year. We have talked about some 
of that. And, it is not inconceivable that an ill-intentioned 
actor could purposefully introduce an equally dangerous and 
contagious pathogen into the United States to really mess with 
our food security, our trading relationships, and our economic 
security.
    And, I know I am going a little over time, but, to that 
end, what is the USDA doing to prepare for the threat of 
bioterrorism? Can you give us a broad overview on that?
    Senator Carper. Mr. Shea, I am going to ask you to suspend 
your answer just for a second. I am very much interested in 
your answer, but Senator Portman has a dead stop right now and 
he needs to go.
    Senator Ernst. OK.
    Senator Carper. If we can just yield to him for a moment, 
and then we will go back to you.
    Senator Ernst. Thank you. Yes.
    Senator Carper. Thank you.

              OPENING STATEMENT OF SENATOR PORTMAN

    Senator Portman. Thank you, Senator Ernst, and thank you, 
Senator Carper, and thank you for having this hearing--you and 
the Chairman. This is an incredibly important area. I have a 
number of questions I am going to be submitting for the record, 
probably to each of you--at least to three of you--as I see you 
there. But, I want to focus on a single issue, Dr. Hatchett, if 
I could. We talked a lot about Ebola today. We have also talked 
about the Zika virus. And, they are very different. My 
understanding is that the way in which someone becomes 
contagious with Ebola creates a health problem in and of 
itself, whereas, with Zika, it is not as easily transmitted 
from person to person. However, it is transmitted from 
mosquitoes to people very easily. And, I just wonder what you 
think we could do, in terms of leveraging all of our assets--
including one that happens to be situated in Youngstown, Ohio, 
which is the 910th. It is the airlift wing there that provides 
aerial spraying for our country. They do incredible work on our 
firing ranges. They do work with regard to oil spills. But, 
they also do work with regard to mosquito infestations. Do they 
have a role here with regard to Zika, particularly, in spring 
in the southern part of the country, where we can see, 
unfortunately, a movement from Latin America up toward the 
United States?
    Dr. Hatchett. Senator, thank you for that question. Vector 
control, which is what you are referring to, in terms of 
controlling mosquito populations, is an area that CDC, I think, 
has primary responsibility for, so, if I could yield to my 
colleague to let him address your question.
    Dr. Redd. It is hard to give a global answer to that 
question. The variability of mosquito control districts in the 
United States is remarkable. Some localities have really finely 
honed enterprises, while others have hardly any at all. I think 
that there could be a role for that airwing in locations that 
do not have the capability and need it.
    Something that we think is really important, that the Zika 
virus outbreak is pointing out, is the need to really 
revitalize those mosquito control efforts--not only for 
control, but really just to understand what is going on--that 
part of what those mosquito control districts do is capture 
mosquitoes and speciate them, and we just do not have the 
information that we need right now in the United States to make 
the best decisions.
    Senator Portman. Well, thank you, Dr. Redd, and thank you, 
Senators. I want you to know the 910th is ready and willing--
and they, again, do outstanding work. And, I think it would be 
a way to leverage some of those DOD assets to address a very 
real, potential biological issue that we are currently facing--
just as we did with Ebola over the last couple of years.
    Thank you.
    Senator Carper. Senator Ernst.
    Senator Ernst. Thank you, Ranking Member. I will go ahead 
and just submit the questions for the record in the interest of 
time.
    Senator Carper. Well, go ahead and respond to the question. 
It was a good question.
    Senator Ernst. I have a hard stop also.
    Senator Carper. That is OK. I would like to hear the 
answer, and then we will go--actually, it is a great question, 
so go ahead. Just briefly.
    Senator Ernst. Yes, bioterrorism efforts.
    Mr. Shea. OK. Of course, we work very closely with our 
colleagues in Homeland Security's Customs and Border Protection 
(CBP), who actually conduct inspections of things and people as 
they are coming into the country. So, that is our very first 
line of defense--looking for things.
    But, after that, what is important, of course, is finding 
any outbreak quickly. And so, surveillance is really the key. 
We have surveillance on farms, in markets, and in feedlots--
everywhere. And, that surveillance comes not only from USDA 
people, but, more abundantly, from State people and from 
private veterinarians who we accredit at USDA. And, when they 
find a disease, they are duty-bound to report that to us. So, 
that is really the key--surveillance, prevention, keeping these 
things out of the country, and getting on it right away.
    Some other things that are going on, of course--at DHS, 
they are developing countermeasures at the Plum Island Animal 
Disease Center (PIADC)--soon to be relocated, but they are 
working very hard there to find countermeasures and detection 
methods. So, all of those things are in place now.
    Senator Ernst. Just to follow up with that then, as we are 
preparing for potential incidents, is it important that we have 
stockpiles of vaccinations or other veterinary supplies then, 
to safeguard?
    Mr. Shea. Absolutely. We do have a veterinary stockpile, 
but it certainly is not robust enough to handle a really huge 
outbreak of foot-and-mouth disease, for example. We do have a 
good capacity now for the avian influenza vaccine, but we do 
not have a huge stockpile of some of the others.
    Senator Ernst. Thank you.
    Chairman Johnson [presiding.] Senator McCaskill.

             OPENING STATEMENT OF SENATOR MCCASKILL

    Senator McCaskill. Thank you.
    I understand that there are several advisory committees 
involved in the material threat assessment process and the 
material threat determination process that include 
nongovernmental experts. These determinations are, in fact, the 
guidance that DHS uses when considering a particular chemical, 
biological, radiological, or nuclear weapon to be a threat and 
allows HHS to use the BioShield funding for countermeasure 
procurements.
    So, my question to you, Doctor, is: Is anyone on these 
committees associated with any of the companies that are 
actually getting the funds for the research and development on 
possible countermeasures?
    Mr. Firoved. The Science and Technology Directorate is the 
organization that runs the terrorism risk assessments and the 
material threat assessments. While I have been involved in the 
process, I am not knowledgeable as to the membership that they 
rely on when they put those together.
    Senator McCaskill. If you would get that for the record, 
that would be helpful.
    Mr. Firoved. I will, absolutely.
    Senator McCaskill. I have had a hearing on this, in 
previous years, with the person that you just referenced and 
was frustrated with what I thought--and I am going to go into 
that a little bit because I think it is relevant to the hearing 
today--about what we are warehousing and why, as well as what 
we are spending money on.
    If you look at the funding decisions, the priorities, and 
the tradeoffs, we spent $1.4 billion on anthrax 
countermeasures, alone. 2 of the investments were for anthrax 
antitoxins that cost $3,100 and $8,200 per dose. We also bought 
10 million doses of BioThrax, which only has a 4-year shelf 
life. And, we bought that vaccine in 2005. And then, we bought 
another 18.75 million doses 2 years later. Now, all of that 
money is--I mean, I understand you have to spend money to be 
prepared, even if you do not use it. I get that. But, it 
appears to me that anthrax investment is crowding out other 
countermeasures in terms of funding. And, I would like someone 
to address that, because, while we had one anthrax attack, it 
seems to me that the cupboard is bare in a lot of other areas 
where we need to have BioShield funds being used. And, I would 
appreciate it if someone would address that, especially since 
Dr. Lurie, when I talked to her about anthrax, basically said 
that it is a therapeutic that, potentially, could be effective 
against an antibiotic-resistant anthrax infection. There was 
not even certainty that it would be. Dr. Hatchett.
    Dr. Hatchett. Yes, ma'am. Good to see you, ma'am. Thank you 
for the question. Your question has multiple parts. I will try 
to be brief and address all of them.
    With respect to the anthrax antitoxins, we do have very 
limited treatments for anthrax disease. And, we now have 3 
licensed anthrax antitoxins, so FDA has judged that, based on 
the best available evidence, those products are likely to be 
safe, effective, and produce a survival benefit against 
anthrax. Anthrax certainly is one of our top threats--and we 
have made very substantial investments to secure the Nation 
against future anthrax attacks.
    To address your question about whether it is crowding out 
other products, I have to say it is not. We--as the Office of 
the Assistant Secretary for Preparedness and Response--as you 
know, are the stewards of the Project BioShield funding. Over 
the last 12 years, we have added 17 products to the Strategic 
National Stockpile using Project BioShield funding. Those 
products include products, yes, to treat anthrax--both vaccines 
and antitoxins--but also antivirals and vaccines to treat 
smallpox, antitoxins to treat botulism, drugs and treatments 
for acute radiation syndrome (ARS), exposure to chemical nerve 
agents, and, most recently, we have added 4 products to the 
Strategic National Stockpile to address the risk of thermal 
burns that could be associated with explosions, bombings, or 
the detonation of an improvised nuclear device (IND).
    We have a number of new products that we will be procuring 
this year. We anticipate adding as many as 5 new products to 
the Strategic National Stockpile this year. Only 2 of those are 
for anthrax, but they also include treatments for smallpox and 
acute radiation syndrome. And, we may add as many as 5 new 
products next year.
    So, we have been able to buildup a diverse portfolio of 
medical countermeasures against CBRN threats.
    Senator McCaskill. Does the smallpox purchase include 
IMVAMUNE?
    Dr. Hatchett. We have purchased significant amounts of 
IMVAMUNE over the last several years.
    Senator McCaskill. Is it not a problem that a scientific 
journal, ``Biosecurity and Bioterrorism,'' said, unequivocally, 
that there is no apparent programmatic use for this vaccine at 
this time? In fact, 7 years after the initial procurement, it 
is not recommended--the advisory group--the World Health 
Organization's advisory group--said it is not recommended for 
emergency use.
    Dr. Hatchett. I would respectfully disagree with the 
statement that it has no programmatic use. IMVAMUNE was 
created, specifically, to be a vaccine that we could give to 
immuno-compromised populations or persons who had relative 
contraindications for the existing smallpox vaccine--and that 
includes persons with a history of atopic dermatitis. That is a 
substantial number of people who could have a potentially 
severe reaction to the other available smallpox vaccines.
    Senator McCaskill. That makes sense. I just am concerned 
because the World Health Organization's scientific advisory 
group of experts noted, in 2014, that it was not recommended 
for emergency use--and we have spent $650 million on it. I hope 
that would always raise the hackles of somebody sitting in this 
chair who is trying to figure out what is going on. I mean, why 
are we spending that kind of money when, clearly, there are 
real questions about its efficacy and its Section 5.
    Dr. Hatchett. We also have very substantial stockpiles of 
the Acambis vaccine, which can be administered in an emergency 
use setting. The potential concern about the IMVAMUNE vaccine 
is that it requires 2 doses to achieve immunity. For those 
people who have been exposed to persons with known smallpox, 
there is no absolute contraindication for the existing vaccine. 
And, if it is given up to 3 or 4 days after exposure, it can 
protect individuals who have been exposed to smallpox, and so, 
that may be the basis of that discussion. But, IMVAMUNE clearly 
is efficacious and clearly meets an unmet medical need for a 
large segment of the population.
    Senator McCaskill. I know I am out of time. I have one 
more. Do you mind?
    Chairman Johnson. You are doing a good job.
    Senator McCaskill. I want to make sure that we have time.
    I get that we are reliant on small start-up companies for 
developing some of these drugs because of the nature of the 
market and the nature of the research. And, the economics do 
not make sense for some of the big guys. So, I get that we have 
to fund a lot of this. But, what I do not get is--take ABthrax, 
for example. We gave Human Genome Sciences $130 million for 
late-stage development activities to support approval of the 
product, including support for non-clinical, clinical, and 
manufacturing facilities--as well as funds for the licensing 
and approval process. I mean, this was our baby--the taxpayers' 
baby.
    Well, then we have to turn around and buy it from them for 
$3,000 a dose. Most people in Missouri do not understand that--
why we would pay for the development of a drug and then have to 
pay $3,000 a pop for the drug after we paid to develop it.
    Dr. Hatchett. So----
    Chairman Johnson. Good question.
    Dr. Hatchett. Yes, it is a good question. I will say that 
the pricing of medical countermeasures is complex. A factor 
that we have to take into consideration is that, because these 
products do not have commercial markets, we have to provide a 
sustaining revenue that will allow for the manufacturing base 
to remain intact. And, the price that you quoted for a 
monoclonal antibody therapeutic is very clearly in the middle 
of the range for other--there are dozens of licensed monoclonal 
antibody therapeutics for many other indications, and the 
prices for those products range from slightly less than the 
amount that you mentioned to substantially more. So, I would 
argue that it is a fair price for the product.
    Senator McCaskill. Have we explored whether it would be 
cheaper to do this ourselves? We are paying them to develop the 
drug, and then we are the only customer, and so, we are 
continuing to pay them--I mean, it seems like, to me, that we 
are guaranteeing a profit for something that is wholly owned by 
the government.
    Dr. Hatchett. If I could just say that we do look at 
different business models for how we support biodefense 
countermeasures. In a related domain, for emerging infectious 
diseases, we have a similar market failure problem. And, we are 
thinking through different potential approaches to how we can 
support companies and how far we would like the private sector 
to carry products and, potentially, what options we may have to 
ensure that we can have those products when we need them--which 
might include the scenario you mentioned.
    Senator, if I could mention another thing that I think you 
would be interested in. In framing your question initially, you 
did talk about the shelf life of products. And, BARDA does have 
a total life-cycle cost containment initiative that we have 
been supporting for many years, where we look at the products 
that we are developing and try to find ways to reduce that 
long-term carrying cost to the taxpayer. And so, for example, 
you mentioned the IMVAMUNE product--the smallpox vaccine. BARDA 
has supported the development of a lyophilized--or freeze-
dried--version of that product which will have a longer shelf 
life----
    Senator McCaskill. Which will help the shelf life--that is 
terrific.
    Dr. Hatchett. And, we are doing that across the board. And, 
we are looking across our entire portfolio to see how we can 
reduce those costs.
    Senator McCaskill. Well, I have been involved in this other 
investigation where a guy named Martin Shkreli figured out that 
there was a limited market for a certain drug, and he went out 
and bought it, and then he jacked the price up. So, maybe, we 
need to take a page out of his book and jack the price down. 
Maybe, we figure out what the price is to buy the drug that we 
paid to develop and continue to manufacture it ourselves and 
drive that cost way down, because, now, we are taking out the 
profit that the private company is making from our investment. 
I mean, believe me, I do not quarrel with a private company 
being able to make money off of their investment. But, it seems 
weird that we are making the investment and then they can 
profit off of theirs for the life of the company. That is the 
kind of deal that any businessman would like to get.
    Dr. Hatchett. Yes, ma'am, thank you. We are always looking 
at ways that we can be better stewards of the taxpayers' money. 
We recognize our responsibility and we recognize that we do 
provide a great deal of that up-front investment. And so, we 
can take that for----
    Senator McCaskill. Yes, I would love you to take a look at 
that, because I am not sure this business model makes a lot of 
sense for the taxpayers.
    Dr. Hatchett. Thank you.
    Senator McCaskill. Thank you, Mr. Chairman.
    Chairman Johnson. Thank you, Senator McCaskill. Senator 
Carper.
    Senator Carper. Thank you, Mr. Chairman.
    I want to come back to Mr. Shea. Just briefly, I want to 
follow up on Senator Ernst's question with respect to the avian 
influenza outbreak. Senator Johnson's State was hit hard--and a 
number of other States in the Midwest were hit hard--especially 
their turkeys and laying hens, and we saw that happen, I think, 
between November 2014 and May and June of last year. And, we 
fully expected the East Coast--the ``Atlantic Flyway''--to be 
hit this winter--and it just has not happened. And, we have 
been pretty good with biosecurity. But, why do you think we 
have escaped this blow?
    Mr. Shea. Of course, all of the scientists will tell me it 
is all speculative, but some of the reasons seem to be 
something like this:
    First, the virus circulating in the water fowl may have 
mutated to a less virulent form, and, therefore, when they are 
dropping the virus, it is simply not catching on like it did 
last year in a highly pathogenic form. So that is a 
possibility.
    Another possibility is that the biosecurity has improved--
and I think it has improved dramatically, certainly in 
Delmarva, where poultry is so important, and throughout the 
Midwest and all of the places where poultry is. And, poultry is 
in so many places, of course. I think biosecurity is much 
better.
    So, I think those are some of the things that seem to have 
led to it.
    Senator Carper. All right. Thank you.
    I do not know who to ask this question to, but I will start 
with you, Dr. Redd. Would you talk to us about what the 
difference--or similarity--is between how Ebola is transmitted 
from 1 human being to another, as compared to the Zika virus, 
please?
    Dr. Redd. Sure. I will start with Zika. It can be 
transmitted by an infected mosquito, it can be transmitted by 
sexual transmission, and it, probably, can be transmitted by 
blood transfusion. There is no instance where that has 
occurred, but it is a possibility based on the way other 
similar viruses can be transmitted in blood.
    Ebola is not transmitted by mosquitoes. It can be 
transmitted by sexual transmission, but its primary route of 
transmission is through contact. So, by coming into physical 
contact with the body secretions of a person who is infected--
where the virus multiplies to very high titers--and then, it is 
really just through that direct contact.
    Senator Carper. Thank you. The CDC announced this week, as 
was described earlier, that the Zika virus is now confirmed to 
be a source of significant brain damage to developing fetuses. 
There are a lot of policy consequences that flow from that. 
But, just take a minute or 2 and talk to us about what actually 
happens to the brain of--and it does not happen to all pregnant 
women. Why is that? But, what is actually happening in the 
brain of the developing fetus? And, what is the capability--if 
a child is born alive, what are some of the consequences there?
    Dr. Redd. So, a couple of points. This declaration is not 
changing what we are doing. Actually, part of the reason behind 
making this declaration was to try to make it easier to move 
quickly and, particularly, to take away any of the confusion 
people might be having when they are deciding whether or not 
they should put insect repellent on. There is no question, now, 
that those preventive measures are very important to prevent 
something that is confirmed.
    When a fetus is infected, the brain is actually infected, 
and that was--an early finding was actual--on microscopic 
slides, you can see brain tissue and the virus right there. 
What we think happens is that the brain actually--because of 
this infection--actually shrinks, so that you have a normal 
fetus, then there is an infection--that brain gets infected and 
it gets smaller--and that is what causes the small heads.
    It is actually--even though the term ``microcephaly'' just 
means small head, the kind of--in these severe cases, it is 
actually a very particular kind of malformation that was very 
rare up until this point, where the plates of the skull of the 
fetus are actually overlapped because of that collapse. The 
skin has ridges in it--and that is not part of kind of regular 
microcephaly. So, it is actually a very specific finding.
    Now, even though there is evidence that the Zika virus 
causes this malformation, there are many questions--and you 
actually pointed out several of them. It does not seem that 
every pregnant woman who gets bitten by a mosquito has this 
very severe adverse effect--and we do not know why that is. We 
do not really know--there is a likelihood that there is a 
certain time during pregnancy that poses the greatest risk. 
That is a little bit of the speculation. We also suspect that 
there are other adverse events that can occur, which is typical 
of other birth defects. They rarely are just a single thing. 
And, we do not really have good information on that entire 
spectrum of disease.
    Senator Carper. Do we have any idea of the degree to which 
a baby born with this disease--this brain disease that you have 
described--to what extent does it impair their ability to 
function?
    Dr. Redd. It really depends on the severity--and that is 
the question of the spectrum of illness. For the ones that are 
very severely affected, I mean, there are deaths right at the 
time of birth. So, that would be kind of the extreme--or deaths 
before birth. And, I think you can go all the way down the 
line--that there may be much less severe findings in what, 
right now, look like normal births.
    Senator Carper. OK. And, for the panel, a last question. 
What good, just common-sense, practical advice can you give to 
people who are going to be traveling to parts of this country 
or to other countries, and are concerned about possible 
infection? What good advice can you give people?
    Dr. Redd. Well, our advice--that has expanded to include 
more places where the virus is actively being transmitted--is 
if you are pregnant, it is probably not a good idea to go. If 
you do go, use mosquito-prevention measures--an effective 
insect repellent, insecticide on your clothes, long sleeves, 
light-colored clothing, and do what you can to avoid being 
bitten by a mosquito.
    Senator Carper. Any other advice from anybody else?
    [No response.]
    All right. Thank you. Thank you very much, Mr. Chairman. 
Thank you all.
    Chairman Johnson. Thank you, Senator Carper.
    Just really quickly, there is only 1 species of mosquito 
that carries this. Is that true or not?
    Dr. Redd. There is 1 vector that is presumed to be the 
predominant vector. They are both Aedes mosquitoes. There is 
Aedes aegypti, which is thought to be the predominant vector. 
Aedes albopictus is thought to possibly also be a vector.
    Chairman Johnson. So, what is the status of the program to 
use genetically modified mosquitoes to, basically, make the 
population sterile in order to reduce the population of those?
    Dr. Redd. I will have to get back to you with the specifics 
on that. I think there are a number of--well, there is a 
programmatic approach of using indoor residual and outdoor 
residual spraying that is being used in Puerto Rico for 
pregnant women to prevent mosquitoes--basically killing 
mosquitoes right there--and also putting larvicides in 
potential breeding spaces of those mosquitoes as well as 
removing potential breeding spaces.
    There are a number of kind of experimental--or less 
widespread--uses, and, in all of this, we really need to learn 
the effectiveness of these measures because this is a very 
difficult mosquito--not to kill at an individual level, but to 
be sure that there are enough mosquitoes being killed to reduce 
transmissions.
    Chairman Johnson. OK. Can anybody else speak to the status 
of using genetically modified--OK. So, it is just experimental 
at best.
    Let me close out the hearing. I will just kind of go down 
the panel. Based on the Blue Ribbon Study Panel on Biodefense's 
conclusion that we do not have a strategy--we do not have any 
kind of functioning leadership here, both budgetary as well as 
operational--you are all involved in these organizations. I 
have been at organizations that have a very well defined 
strategy and you know it. I have been at organizations that do 
not have a strategy--I am kind of in one right now--where you 
also know it. So, I want to get your evaluation and--if you are 
saying you agree with GAO--if you agree with the Blue Ribbon 
Study Panel on Biodefense, you do not have to say a whole lot 
more. But, if you disagree, just quickly tell me--what is the 
disconnect, in terms of what GAO and the Blue Ribbon Study 
Panel on Biodefense are talking about--a lack of strategy, a 
lack of coordination, and a lack of unity of effort? I will 
start with you, Dr. Hatchett.
    Dr. Hatchett. Thank you. I think the problem of biodefense 
is a tremendously far-reaching problem, and it stretches to all 
sectors of society--actually, to all parts of government. 
Within the domain that we work in, which is public health and 
medical preparedness and response, I feel that we do have 
strong strategies, we do have strong collaborative mechanisms, 
and we have adequate structures in place to respond to the 
emergencies that we are presented with.
    Chairman Johnson. Dr. Redd.
    Dr. Redd. So, I think there is a policy process to make the 
kinds of changes that are being proposed--and that involves the 
legislature and the Executive Branch. And, this is a 
recommendation that needs to be looked at very carefully.
    Chairman Johnson. Mr. Shea.
    Mr. Shea. I certainly agree with them. I would say that so 
many great things are going on between our respective agencies 
and I think, if those could all be brought together, probably--
certainly--it would be to our advantage.
    Chairman Johnson. OK. Dr. Firoved.
    Mr. Firoved. Sure. I think that we are certainly taking to 
heart the Blue Ribbon Study Panel on Biodefense's 
recommendations. We are trying to implement as many of them as 
we can. I think there are strong strategies. I think there are 
strong coordination mechanisms. We have touched on a few of 
them today, but there are many more. We are never going to be 
done. I think one of the things that strikes me is, after 9/11, 
when we were talking about interagency coordination to address 
it, so that we could connect the dots, there was one anecdotal 
story that someone stood up and said, ``I thought we were going 
to do this after Pearl Harbor.'' And so, this is a task that is 
never done. And, we will always have to strive and we are 
always going to have to grow and build these capabilities.
    Chairman Johnson. Listen, I come from a manufacturing 
background. It just gets into your genes--continuous 
improvements. So, everything always can be improved.
    Mr. Currie, just a final comment. Again, the gentlemen here 
think there are certainly strategies--certainly areas for 
improvement. Is that a pretty accurate assessment from your 
standpoint?
    Mr. Currie. Probably not surprising to hear we think 
strategy is important. And, I do not want to take away from 
some of the efforts that have been done. The public health 
strategy that Dr. Hatchett mentioned, I think, is probably the 
closest thing to such a comprehensive strategy. I think if I 
had to nail 1 key thing that is not being done that makes it 
difficult, it is this idea of being able to prioritize 
investments and prioritize efforts. Within each area, you can 
do that because the agencies and departments have control of 
those areas. But across, you cannot.
    Chairman Johnson. Yes, so, at the agency level, you think 
you are doing a pretty good job of prioritizing, but, again, it 
is that top-down allocation of resources.
    Well, again, thank you all for your time, your testimony, 
and your answers to our questions. The hearing record will 
remain open for 15 days, until April 29 at 5 p.m., for the 
submission of statements and questions for the record.
    This hearing is adjourned.
    [Whereupon, at 11:51 a.m., the Committee was adjourned.]

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