[Senate Hearing 115-720]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 115-720

                       FACING 21ST CENTURY PUBLIC
                            HEALTH THREATS:
                       OUR NATION'S PREPAREDNESS
                   AND RESPONSE CAPABILITIES, PART II

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                                   ON

 EXAMINING FACING 21ST CENTURY PUBLIC HEALTH THREATS, FOCUSING ON OUR 
            NATION'S PREPAREDNESS AND RESPONSE CAPABILITIES
                               __________

                            JANUARY 23, 2018
                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                

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        Available via the World Wide Web: http://www.govinfo.gov
        
                              ___________

                    U.S. GOVERNMENT PUBLISHING OFFICE
                    
28-514 PDF                 WASHINGTON : 2019        
        



          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman
                  
MICHAEL B. ENZI, Wyoming		PATTY MURRAY, Washington
RICHARD BURR, North Carolina		BERNARD SANDERS (I), Vermont
JOHNNY ISAKSON, Georgia			ROBERT P. CASEY, JR., Pennsylvania
RAND PAUL, Kentucky			MICHAEL F. BENNET, Colorado
SUSAN M. COLLINS, Maine			TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana		CHRISTOPHER S. MURPHY, Connecticut
TODD YOUNG, Indiana			ELIZABETH WARREN, Massachusetts
ORRIN G. HATCH, Utah			TIM KAINE, Virginia
PAT ROBERTS, Kansas			MAGGIE HASSAN, New Hampshire
LISA MURKOWSKI, Alaska			TINA SMITH, Minnesota
TIM SCOTT, South Carolina		DOUG JONES, Alabama
                                     
                                                                          
               David P. Cleary, Republican Staff Director
         Lindsey Ward Seidman, Republican Deputy Staff Director
                 Evan Schatz, Democratic Staff Director
             John Righter, Democratic Deputy Staff Director



                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                       TUESDAY, JANUARY 23, 2018

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening Statement.........................     1
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina, Opening Statement....................................     2
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of 
  Pennsylvania, Opening Statement................................     3

                           Witnesses--Panel I

Inglesby, Tom, MD, Director, Center for Health Security, Johns 
  Hopkins Bloomberg School of Public Health, Baltimore, MD.......     6
    Prepared statement...........................................     8
Dreyzehner, John J., MD, MPH, FACOEM, Commissioner, Tennessee 
  Department of Health, Nashville, TN............................    13
    Prepared statement...........................................    15
MacGregor, Brent, Senior Vice President, Commercial Operations, 
  Seqirus, Co-Chair, Alliance for Biosecurity, Summit, NJ........    18
    Prepared statement...........................................    20
Krug, Steven, MD, FAAP, Head, Pediatric Emergency Medicine, Ann & 
  Robert H. Lurie Children's Hospital of Chicago, Professor of 
  Pediatrics, Northwestern University Feinberg School of 
  Medicine, Chair, Disaster Preparedness Advisory Council, 
  American Academy of Pediatrics, Chicago, IL....................    23
    Prepared statement...........................................    25

                           Additional Material

 Roberts, Hon. Pat:
     Gen. (Ret.) Richard B. Myers, Prepared Statement............    59

 
                       FACING 21ST CENTURY PUBLIC
                            HEALTH THREATS:
                       OUR NATION'S PREPAREDNESS
                   AND RESPONSE CAPABILITIES, PART II

                              ----------                              


                       Tuesday, January 23, 2018

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:05 a.m. in 
room SD-430, Dirksen Senate Office Building, Hon. Richard Burr, 
presiding.
    Present: Senators Alexander, Burr [presiding], Isakson, 
Cassidy, Young, Roberts, Casey, Baldwin, Murphy, Warren, Kaine, 
Hassan, Smith, and Jones.

                 Opening Statement of Senator Alexander

    Senator Burr [presiding]. I would like to call the hearing 
to order.
    First off, I would like to recognize the Chairman of the 
Committee for a statement.
    The Chairman. Thank you, Senator Burr, and Senator Casey, 
and Members of the Committee.
    I want to thank Senator Burr for chairing the hearing 
today, and Senator Casey for serving as Ranking Member at 
Senator Murray's request. They have both been real leaders on 
this subject.
    Senator Burr was the original author of the first passage 
of the Pandemic and All-Hazards Preparedness Act in 2006. The 
law helps protect us from the full range of public health 
threats: from natural disasters, to bioterror attacks, to 
outbreaks of infectious diseases.
    Then in 2013, Senators Burr and Casey led the bipartisan 
authorization of the Pandemic and All-Hazards Act. Many Members 
of this Committee contributed at that time, some of whom are 
still on the Committee including Senators Enzi, and Bennet, 
Isakson, Warren, Hatch, Roberts, and others.
    Now, the bill needs to be reauthorized for a second time 
and today's hearing is the second we have had this year.
    Last week, we heard from the Administration on 
recommendations in advance of the reauthorization of the Act 
including from the Assistant Secretary for Preparedness and 
Response, the Food and Drug Administration, and the Centers for 
Disease Control and Prevention.
    In the middle of the flu season, it is critical that we 
reauthorize the Act before many of its provisions expire in 
September. I hope we will do this in a bipartisan way and I 
expect that. That has been the tradition with the law and with 
this Committee on almost all of our major bills.
    People are not as aware of the devastation of, for example, 
the flu, and I mentioned the flu season. I believe the figures 
are that between 12,000 and 50,000 Americans die of flu every 
year. Dr. Collins has talked to us about the expediting of a 
universal flu vaccine, which he sees soon.
    Tennessee has seen heartbreaking stories already this 
winter as the flu spread across this state and this country. In 
our state already in this season, a pregnant woman and three 
children in Tennessee have died of the flu.
    The Act provides a public health preparedness framework 
that enables us to be prepared and able to respond to public 
health threats by ensuring that we have enough medicines to 
protect Americans, and to ensure our hospitals and state and 
local health departments are prepared to respond to public 
health emergencies.
    Thanks to all our witnesses for coming here today, 
especially Dr. Dreyzehner, who has come from Tennessee.
    Thank you, Senator Burr.

                       Statement of Senator Burr

    Senator Burr. Thank you, Chairman Alexander.
    This morning, we are holding a hearing entitled, ``Facing 
21st Century Public Health Threats: Our Nation's Preparedness 
and Response Capabilities.''
    We will hear from Dr. Tom Inglesby, Director of the Center 
for Health Security at Johns Hopkins Bloomberg School of Public 
Health; Dr. John Dreyzehner, Commissioner of the Tennessee 
Department of Health; Brent MacGregor, Senior Vice President of 
Commercial Operations for Seqirus and Co-Chair of the Alliance 
for Biosecurity, Summit; and Dr. Steven Krug, Head of Pediatric 
Emergency Medicine at Lurie Children's Hospital in Chicago.
    Senator Casey and I will have an opening statement, and 
then we will hear from the witnesses, and then Members will 
have up to 5 minutes for questions.
    I am pleased to chair this second hearing to inform our 
work on PAHPA. I would like to thank the Chairman, once again, 
for giving the opportunity to Senator Casey and I to lead the 
discussion.
    Today, we will hear from some individuals with firsthand 
knowledge of the challenges we face in combating public health 
threats, and their ideas on how to move forward.
    Since the last PAHPA reauthorization, the emergency 
preparedness and response framework has been tested by the 
emergence of pandemic flu, multiple natural disasters, and an 
Ebola breakout and a Zika virus.
    The lessons learned in these events come from individuals, 
like those sitting before us today, and their efforts to 
protect and to save lives.
    The last hurricane season resulted in three major storms 
devastating many communities and raising new questions about 
our ability to manage and withstand multiple periods of 
response.
    The emergence of Zika emphasized the need for improved data 
collection and surveillance to inform and protect as many 
mothers and babies as possible. Further, the Ebola breakout in 
2014 highlighted the need for an ASPR that brings both the 
knowledge of the potential damage that can be brought by these 
threats and a deep understanding of the effort undertaken for 
research, development, and procurement of medical 
countermeasures.
    I look forward to learning more about the opportunities and 
barriers each of you see to better leverage innovative 
technologies to solve these problems.
    Whether it is the challenge in the development of a 
vaccine, the information crucial to a public health department 
in the midst of a crisis, the infrastructure a doctor needs to 
rapidly care for patients, or improvements to the ways these 
policies complement one another, your experiences reminds us 
that we cannot let up on these efforts or lose sight of the 
urgency this mission demands.
    We must not get distracted by making changes to the laws 
that are outside of our focus of perfecting PAHPA, improving 
and strengthening our policies and programs to make them more 
effective now and in the future.
    I look forward to the insight each witness can provide.
    Now I would turn to Senator Casey for any remarks he would 
like to make.

                       Statement of Senator Casey

    Senator Casey. Thank you, Senator Burr.
    I want to thank Senator Burr for his years of work on these 
issues.
    I want to thank, as well, the leaders of this Committee, 
Chairman Alexander and Ranking Member Murray, for this 
opportunity.
    Also, of course, I want to thank our witnesses for bringing 
their experience and work to these issues, and for joining us 
today.
    This is our second hearing on this topic and the focus, of 
course, is our Nation's preparedness to combat public health 
threats as we look toward reauthorizing the Pandemic and All-
Hazards Preparedness Act later this year.
    Now, more than ever, we must continue to build our Nation's 
resiliency to help security threats. The threats that face our 
Nation today are increasing in both frequency and intensity. It 
is critical to foster and advance innovation and drugs, 
devices, and diagnostics.
    Yet, when we are considering an emerging infectious 
disease, or an engineered bioweapon that has yet to be seen by 
man, or the response to a natural disaster like a hurricane, we 
do not and will not have a vaccine or a countermeasure to 
protect us from these scenarios.
    In addition to supporting biomedical innovations, we must 
also strengthen our hospitals and our public health 
professionals, our frontline of defense against these health 
threats.
    We must ensure that we give our communities the necessary 
tools and support they need to be ready when, not if, the next 
emergency strikes. By all accounts, we have come a long way.
    I spoke at the last hearing about the success of the 
Hospital Preparedness Program, the so called HPP and PHEP, the 
Public Health Emergency Preparedness Program in the context of 
a train derailment in Pennsylvania. One of many examples we 
could cite.
    But these grants for these programs also facilitate 
preparedness activities that help hospitals and public health 
systems with more regular occurrences.
    For example, when subzero temperatures caused bursting 
pipes in St. Vincent Hospital in Erie, Pennsylvania--and Erie 
got hit worse than anyplace with snow this year--the hospital 
contacted the local emergency management agency and also the 
regional healthcare coalition, created through HPP funding, who 
assisted in the response in that circumstance.
    Yet, the funding for these preparedness programs has 
decreased from PAHPA to PAHPRA with appropriations falling 
behind authorized levels, spiking only in the response to Ebola 
and Zika.
    The impact of funding reductions means a decrease in the 
amount of time that hospitals and medical staff have to plan 
and train for an emergency; and the loss of thousands of public 
health jobs, and the reduction in emergency managers and public 
health lab technicians.
    It is very dangerous to wait for a threat to emerge to try 
to pass emergency funding bills. We must be proactive, not 
reactive.
    How can we improve our healthcare system preparedness and 
our public health capacities, and thereby improve our 
situational awareness in an emergency?
    Can we work toward a precision public health using better 
data to more efficiently guide responses in emergencies to help 
benefit our communities? I think we can.
    For example, it was reported by the publication ``Nature,'' 
when domestic transmission of the Zika virus was confirmed in 
the United States, the entire country was not declared at-risk. 
Instead, precise surveillance defined two at-risk areas of 
Miami-Dade County neighborhoods measuring less than 2.5 square 
miles. This allowed for the targeting of resources to these 
regions.
    Building on that experience, we can expand surveillance to 
illuminate causes of disease and spark opportunities for 
prevention.
    At last week's hearing, we also heard from Assistant 
Secretary Kadlec about the use of emPOWER, the emPOWER program, 
to identify and treat at-risk individuals requiring 
electricity-dependent medical and assistive equipment. Yet, he 
also identified a weakness. This system only pulls in Medicare 
data, not Medicaid and not TRICARE data.
    How do we ensure that we are acting on the data 
appropriately to protect these vulnerable individuals?
    The tragic death of 12 seniors at a nursing home during 
Hurricane Irma in September highlights that more needs to be 
done to protect our most vulnerable citizens. In fact, most of 
our citizens have additional characteristics that make them 
more vulnerable during a public health emergency. This includes 
our children, our parents, our rural communities, individuals 
who have limited English proficiency, individuals with 
disabilities and, of course, individuals with chronic illnesses 
and more.
    We must do better to help our communities to prepare for 
potential health security threats. We must continue to invest 
in innovative biotechnologies and we must also improve our non-
pharmaceutical interventions.
    I am looking forward to the hearing, for the witnesses' 
testimony, and for how we can continue to prepare our hospitals 
and health systems to ensure equal consideration of all of our 
constituents.
    Senator Burr, thank you very much.
    Senator Burr. Thank you, Senator Casey.
    I am pleased that we have our four witnesses here today and 
I thank each of you for taking the time to be here. I would 
like to introduce all four.
    First, I would like to introduce Dr. Tom Inglesby. Dr. 
Inglesby is the Director of the Center for Health Security at 
Johns Hopkins Bloomberg School of Public Health.
    He is internationally recognized for his work as a writer 
with numerous publications focusing on public health 
preparedness, pandemic, and emerging infectious disease, as 
well as the prevention of, and response to, biologic threats.
    Dr. Inglesby, welcome.
    I will now turn to Senator Alexander for an introduction.
    The Chairman. Thank you, Senator Burr.
    I would like to welcome Dr. John Dreyzehner, who is surely 
the tallest Commissioner of Health in our history, maybe in the 
country.
    He has served as Commissioner of the Tennessee Department 
of Health in Nashville since 2011. He has significant 
experience responding to state and local public health 
emergencies including infectious diseases like Zika, and 
natural disasters such as the wildfires that devastated eastern 
Tennessee in 2016.
    Today, he will provide important insights into our Nation's 
preparedness and response capabilities at the state and local 
level, what is working, where we can improve, and where we can 
protect and save more lives.
    Dr. Dreyzehner is a physician with more than 25 years of 
service. As Commissioner of Health, he helps to protect 
Tennesseans from public health threats.
    I appreciate his leadership in Tennessee and we welcome him 
to the Committee.
    Senator Burr. John, I am sure if you were a little younger, 
there are a couple of Tennessee basketball teams that would 
probably recruit you tomorrow given their record this year.
    The Chairman. Well, one of them is doing better.
    Senator Burr. Next, I would like to introduce Mr. Brent 
MacGregor. He is the Senior Vice President for Commercial 
Operations at Seqirus, the second largest flu vaccine company 
in the world.
    Seqirus is an example of the success that can be achieved 
through public-private partnerships to ensure that we are 
better prepared for the threats that face us.
    Their facility in Holly Springs, North Carolina is one of 
three advanced manufacturing facilities in the country with the 
capability to rapidly respond in the event of a pandemic flu 
outbreak.
    Mr. MacGregor is also the Co-Chair of the Alliance for 
Biosecurity. The Alliance works to promote the critical 
partnerships between the Government, industry, and other 
stakeholders to advance and encourage the development of 
medical countermeasures.
    Brent, welcome.
    Finally, Dr. Steven Krug. Dr. Krug is the Head of Pediatric 
Emergency Medicine at the Lurie Children's Hospital of Chicago. 
Dr. Krug is also a Professor of Pediatrics at Northwestern 
University Feinberg School of Medicine, and serves as the Chair 
of the American Academy of Pediatrics Disaster Preparedness 
Advisory Council.
    Dr. Krug, welcome.
    With that, I will turn to you, Dr. Inglesby, and you can 
lead off for up to 5 minutes of testimony.

 STATEMENT OF TOM INGLESBY, M.D., DIRECTOR, CENTER FOR HEALTH 
  SECURITY, JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH, 
                         BALTIMORE, MD

    Dr. Inglesby. Thank you.
    Senator Burr, Senator Casey, Members of the Committee.
    Thank you for the chance to speak today about these 
important issues.
    My name is Tom Inglesby, and I am the Director of the 
Center for Health Security at the Johns Hopkins Bloomberg 
School of Public Health where I am a Professor of Medicine and 
Public Health. Our Center's mission is to protect peoples' 
health from epidemics and disasters, and to build resilient 
communities.
    I will provide a brief overview of key areas that Center 
colleagues and I consider vital to our Nation's preparedness 
and response capabilities. The opinions expressed here are my 
own and do not necessarily reflect the views of Johns Hopkins 
University.
    The U.S. faces a range of major public health threats, any 
of which could occur without much warning. These include 
natural disasters, technological accidents, mass shootings and 
bombings, chemical spills and potential use of chemical 
weapons, radiation and nuclear threats, and biological threats.
    Biological threats, whether they are natural like H7N9 in 
China, or accidental such as an epidemic viral strain released 
from a lab, or deliberate like small pox or anthrax are of a 
particular concern, and thus, a big focus of my comments today. 
Biological threats could range from modest in size up to those 
capable of posing global, catastrophic risks.
    What more can be done to prepare for these threats?
    First, we need to strengthen the healthcare system's 
preparedness. That is, the capacity to care for high numbers of 
sick or injured in an emergency.
    While there has been substantial progress in preparing for 
small disasters in the country, the Nation is not ready to 
provide medical care in large catastrophes or big epidemics of 
contagious disease.
    The APSR Hospital Preparedness Program, or HPP, has been 
helping fund and build these capabilities at the state and 
local level. But significant resource constraints limit what 
HPP can do. Its budget has decreased more than 50 percent since 
it started in 2002. That trend should be reversed.
    New initiatives, like establishing regional disaster 
resource hospitals, could be a strong, new, additional 
component in improving medical preparedness.
    Second, we need to strengthen the ability of our public 
health system to detect and respond to threats.
    Since 2001, there have been serious efforts at the CDC, and 
state and local levels, to provide early warning of new 
outbreaks, provide lab diagnostics, investigate and contain 
outbreaks, communicate to the public, ensure biosafety and 
biosecurity, and much more.
    There has been good, forward movement, but there is too 
much to do and not enough trained professionals to do the work. 
Public health relies on funding from the CDC's Public Health 
Emergency Preparedness grants, or PHEP.
    That funding has been reduced by nearly 30 percent since 
2002 even though public health crises have not declined. PHEP 
should be strongly supported.
    In addition, I believe that a public health emergency 
contingency fund should be established, which would allow 
rapid, public health response funding in emergencies.
    Third, we need to move ahead in medical countermeasure 
development. There has been good progress, but many priorities 
remain including sustained funding in research, development, 
and manufacturing and acquisition of countermeasures; 
transitioning to new flu vaccine technologies; and setting more 
ambitious targets for rapid development of products in 
emergencies so that they are ready in the course of a given 
pandemic or epidemic.
    Fourth, the U.S. needs to recognize threats that could 
inadvertently emerge from biological research.
    After the U.S. moratorium on potential pandemic pathogen 
research was lifted last month, researchers can now again apply 
for funding to study, for example, ways of making the world's 
most lethal viruses, like H5N1 bird flu, respiratory 
transmissible like seasonal flu.
    In the worst case, this could lead to the accidental or 
deliberate release of a novel strain of virus that could cause 
an epidemic or even a pandemic.
    I do not believe the benefits of this work are worth the 
risks, but if it is going to go ahead, I would advise there be 
high transparency in the program and serious dialog among 
concerned governments internationally on how to proceed.
    Finally, we should fund the Global Health Security Agenda, 
or GHSA. In 2014, the U.S. helped launch GHSA with a billion 
dollar commitment to help countries prevent, detect, and 
respond to infectious disease threats.
    Since then, the CDC and USAID have been working in 39 
countries, leading programs to stop antimicrobial resistance, 
increase lab and surveillance capabilities, strengthen public 
health workforces, and much more.
    But at this point, U.S. funding for GHSA is ending soon. If 
we pull away from the GHSA, other countries will likely do the 
same. We should continue to support it. It is the most 
effective program we have to contain international outbreaks at 
their sources overseas.
    Improving our Nation's preparedness and response capacity 
is a daunting, complex endeavor, but I am confident it is an 
achievable goal if we focus our efforts on these initiatives.
    I appreciate the Committee's time and I welcome your 
questions.
    [The prepared statement of Dr. Inglesby follows:]
                   prepared statement of tom inglesby
    Chairman Alexander, Ranking Member Murray, and Members of the 
Committee, thank you for the chance to speak with you today about 
Facing 21st Century Public Health Threats: Our Nation's Preparedness 
and Response Capabilities.
    My name is Tom Inglesby. I'm the Director of the Center for Health 
Security of the Johns Hopkins Bloomberg School of Public Health and a 
Professor of Public Health and Medicine at the school. The opinions 
expressed herein are my own and do not necessarily reflect the views of 
The Johns Hopkins University. Our Center's mission is to protect 
people's health from epidemics and disasters and build resilience in 
communities. We study the organizations, systems, and tools needed to 
prepare and respond, and work to help translate what we find into 
stronger programs and policies.
    I will provide comments on the kinds of threats that the country 
faces, health care system preparedness, public health needs, medical 
countermeasure development, potential pandemic pathogen research and 
the global health security agenda.
                  Public Health Threats to the Country
    The country faces a range of potential sudden, major public health 
threats, any of which could occur without much warning: natural 
disasters including major hurricanes, earthquakes, fires and mudslides; 
technological accidents; mass shootings and bombings; chemical spills 
and the use of chemical weapons, such as we saw on horrific scale in 
Syria; radiation and nuclear threats; and, biological threats, either 
natural, accidental or deliberate. I will say more about biological 
threats given the particular kinds of threats they pose.
    We have seen signs of what natural epidemics can do in recent 
years. We saw what damage Ebola could do when it got into cities in 
West Africa, what MERS did in S Korea when it arrived there, how Zika 
could transmit congenital deformities by mosquito. And health agencies 
around the world are tracking H7N9 in China, the most serious of avian 
influenza potential threats to emerge in years, with case fatality 
rates on the order of 40 percent. If H7N9 ever evolved into a virus 
capable of sustained human to human transmission, it is hard to 
describe how devastating that would be to the world.
    We are also now in an era where there is incredible power in 
biotechnology and science. This power is almost entirely for the good, 
with the development of new medicines, better agriculture, improvements 
to the economy, and more. But with every new technology we need to 
acknowledge the potential downsides of accidental or deliberate misuse. 
It is now possible to engineer new traits into old viruses. For 
example, it is becoming possible to take the lethality of one virus and 
combine it with the contagious qualities of another virus. And, last 
week scientists published research showing how they synthetically could 
create horsepox, a close viral relative of smallpox. We don't have the 
oversight system we need to fully understand or manage these kinds of 
developments yet, either in the U.S. or internationally. Whatever we do 
about this, we need to ensure that we don't slow down science that 
drives so many good things forward. But we also can't ignore that new 
risks are becoming possible.
    Even without the advent of new science, there are the known 
deliberate biological threats including anthrax and smallpox. The 
government's own modelling has shown repeatedly how severe the impact 
could be in the event of larger scale biological weapons use in the 
U.S., and there is continued urgency in preparing for these 
possibilities.
    There is a broad range of potential consequences from biological 
threats. Some are common and of a more modest scale. On the other end 
of the spectrum, some conceivable scenarios could even pose globally 
catastrophic biological risks, with lasting damage to countries and 
societies around the world.
    Given the range of biological scenarios and possible consequences, 
the forthcoming White House National Biodefense Strategy will be of 
great importance in helping to set national priorities, assign agency 
responsibilities, and identify funding requirements.
                    Health Care System Preparedness
    An essential component of medical preparedness is the capacity to 
care for high numbers of sick or injured in the event of an emergency. 
And while there has been substantial progress in preparing for smaller 
disasters, the Nation is not ready to provide medical care in large 
catastrophes or big epidemics of contagious disease.
    For smaller events, there is evidence that preparedness has gotten 
better. We saw this with the response to the Boston marathon bombing in 
which 264 were injured and treated at 27 hospitals-- all victims who 
made it to the hospital survived. The health care and EMS response to 
the Las Vegas shootings was also considered to be effective in 
providing trauma care. Hospitals, for the most part, do well in normal 
flu season, handle smaller outbreaks, and they provide good care for 
the victims of car and bus accidents. The Assistant Secretary for 
Preparedness and Response (ASPR) Hospital Preparedness Program (HPP) 
has been working to help fund and build these capabilities.
    In larger scale infectious diseases emergencies, most U.S. health 
care systems would not do well. It was quite evident how difficult it 
was to care for even one hospitalized Ebola patient, let alone to 
consider how a hospital would handle a larger scale infectious disease 
emergency. The ASPR program to build 10 regional biocontainment units 
(BCUs) was smart, and we should build on that capacity. But it is 
important to know that most of these units can handle only a couple of 
patients at a time. More broadly, there is no surge plan for taking 
care of larger numbers of patients with contagious, potentially lethal 
infectious diseases. If hospitals do need to take care of patients with 
contagious infectious diseases, there could be major disruptions to the 
regular operations of their systems. They will need to protect against 
that, or could put at risk their normal work of taking care of heart 
attacks, delivering babies, performing surgeries, and more.
    If you consider what would be required to manage the ill in a flu 
pandemic or smallpox or after a sizable anthrax event, it is clear that 
hospitals do not have that capability-- they are simply not equipped 
for those larger events, and they are living too close to the margins 
with just in time inventories to be able to surge.
    In larger events, a responding hospital would need to be part of a 
larger entity that connects hospitals to each other and to other key 
parts of the system--a system called Health Care Coalition. HPP has 
funded the creation of these coalitions around the country, and they 
largely comprise of hospitals, public health, EMS. In places where they 
don't already, coalitions should also include minute clinics, surgi-
clinics, pharmacies, mental health and dialysis centers. We saw in the 
response to Hurricane Sandy just how much medical care is delivered in 
the community outside of hospitals themselves, so these kinds of 
organizations need to be prepared to respond in emergencies too. With 
the hurricanes of last fall, we also saw how much the affected 
communities relied on the assistance of ASPR, the emergency personnel 
it led, and the emergency medical assets it helped to provide.
    On a national level, for planning for major epidemics and 
disasters, we should build on the strengths we see in Level 1 Trauma 
Centers and the BCUs to create what could be called specialized 
Disaster Resource Hospitals (DRH). These would be designated facilities 
with special national and regional responsibilities to prepare for 
disasters and epidemics. They would have more reserve in the system, 
better trained people, resources to support a larger mission, and could 
serve as resources to other hospitals. Many would be academic medical 
centers, probably already Level 1 Trauma Centers, probably many would 
be the existing BCUs, because they are already organized to take on 
high end risks and problems that smaller hospitals in system can't 
manage.
    There are other actions we can take to improve our health care 
response. Doctors and nurses should be able to take their healthcare 
credentials acrosslines in order to facilitate response to a regional 
or national emergency.
    We should also be able to rapidly deploy clinicians internationally 
in new outbreaks. We had substantial difficulty doing that in Ebola. It 
would be good for ASPR to work with CDC, State Department, USAID, DoD 
and other partners as needed to develop a plan delineating under what 
conditions, with what personnel, and how clinicians would be officially 
deployed internationally from the U.S. in the event of a pandemic or 
other emergency of international concern. Early deployment of clinical 
experts could help outbreaks overseas from becoming out of control and 
spreading.
    The U.S. government should put in place a plan for conducting 
research during public health emergencies to study new medicines, 
vaccines, and other clinical and public health interventions to gauge 
whether they are effective and safe. We have seen in past epidemic 
responses that a number of new products and efforts are tried, but not 
necessarily in careful ways that create the evidence needed to 
determine effectiveness and safety. Clinical trial designs that help us 
answer those questions should be worked out ahead of any crisis.
    Overall, we need a stronger approach to prepare for the most 
serious catastrophes that could hurt the country. We need planning for 
the most consequential of the FEMA national planning scenarios. In the 
dozen years since these scenarios were issued, we have not made a lot 
of progress in the health care system in being able to respond 
effectively to many of the threats detailed in those scenarios. A vivid 
example of this was Hurricane Maria that destroyed the basic 
infrastructure that we need to provide medical care to victims.
    In terms of resources, the HPP budget of $250M is down from $515M 
at its inception. This is worrisome, given what we have learned about 
how hard it is to prepare to provide mass care for the range of 
emergencies experienced by Americans. The HPP program should be 
supported at a higher level, and other avenues of funding should be 
explored for funding a new DRH program. Possible additional Federal 
funding avenues to explore include adding a modest amount of additional 
reimbursement for each Medicare and Medicaid admission to DRHs. This 
could help reduce the uncertainties surrounding annual appropriations 
for preparedness that come through the annual HPP program. In any 
event, ASPR and its mission to build national preparedness, including 
the hospital preparedness program and the medical countermeasure 
enterprise, need to be strongly supported.
                       Public Health Preparedness
    Another national pillar for preparedness is the capacity of our 
public health system to detect and respond to public health crises. 
Since 2001, there has been a major effort at CDC and around the country 
at a state and local level to build programs that would help provide 
early warning of new outbreaks, provide laboratory diagnostics, 
investigate and help contain outbreaks, communicate risk to the public, 
ensure biosafety and biosecurity practices and more.
    A great deal of progress has been made, and there is a committed 
cadre of public health officials working on these issues around the 
country to protect Americans during times of public health crisis. But 
there is too much to do and not enough trained professionals to do it. 
The public health workforce has been reduced by budget pressures by 
tens of thousands in the last decade. This is the same public health 
workforce that every day deals with urgencies like the opioid crisis, a 
nasty seasonal flu season, outbreaks of diseases like measles or 
norovirus in a school or meningitis on a college campus or legionella 
in an apartment building, medicine and vaccine shortages, HIV, 
hepatitis, tuberculosis, the safety of water supplies, and so much 
more. The National Health Security Preparedness Index, which measures 
state by state capacities in key areas of public health, shows an 
average state score of 6.8/10, with substantial variation around the 
country.
    Public health agencies critically rely on funding from the Public 
Health Emergency Preparedness Program (PHEP) program administered by 
the CDC to prepare for emergencies. That funding has been reduced to 
$660M from $940M in 2002, and yet the public health crises faced by 
Americans have not commensurately declined. Early in 2018, the 
Administration proposed substantial cuts to PHEP grants. Congress 
didn't go along with those cuts. I am hopeful that this year, the 
Administration will recognize the role of the PHEP program and public 
health grants in preparing the country for disasters and epidemics that 
befall our communities. There should be more funding for public health 
preparedness for emergencies, not less. If current funding goes down or 
away, public health jobs are cut, key labs don't get supported, 
outbreak investigations will be slowed, disease surveillance programs 
will suffer, along with the rest of what public health provides every 
day and in emergencies.
    Some have asked whether there should be changes made regarding 
which states and cities should receive HPP and PHEP funding based on 
some new determination of risks. We haven't seen evidence that serious 
changes to the programs' formulas would provide meaningful benefit or 
that the current formula is flawed (currently there are already risk-
based considerations in both formulas). Funding formulas that lean too 
heavily on risks from prior natural disasters ignore both universal 
risks, such as an influenza pandemic or other outbreaks, and 
unpredictable threats such as acts of terrorism and mass shootings. 
Because disasters can occur anywhere in the U.S., preparedness should 
occur broadly around the country.
    Within CDC too there are essential public health preparedness 
programs that should be noted, including the programs that provide 
support and technical preparedness assistance to states and locals 
public health agencies; the Biosafety and Select Agent and Toxin 
program; the Strategic National Stockpile of meds and vaccines we will 
need in crises; a range of critical disease surveillance programs; and, 
the Emergency Operations Division which is the nerve center for CDC's 
deployments around the U.S. and the world. These programs need to 
continue to be supported.
    There is a new proposed element in public health preparedness that 
should be supported--a Public Health Emergency Contingency Fund. We saw 
during the initial response to Zika that it took more than 230 days to 
get emergency appropriations for that epidemic. A way to address this 
would be to create a new Fund that allows rapid access funds in the 
aftermath of an emergency. Such a fund should supplement and not 
supplant existing public health and preparedness grants which are 
needed in order to have a public health essential workforce, labs, and 
infrastructure in the first place, and to prepare for the range of 
disasters and epidemics that could arise. A Public Health Emergency 
Contingency Fund would allow rapid initiation of responses to acute 
emergencies so that families and children wouldn't have to wait for a 
special appropriation before help could start. Resources from that fund 
could be made available immediately following a public health emergency 
declaration, with reporting requirements to Congress following the 
initial emergency period and an automatic process to replenish funds 
when depleted. A balance of $500 million to $1 billion would be 
appropriate based on past emergency appropriations for Zika, Ebola, and 
H1N1. It would be enough to get the emergency response started for 
public health, the healthcare system, and for initiation of medical 
countermeasure development, but may not be sufficient for the extended 
response, which would need to come through emergency congressional 
appropriations.
                   Medical Countermeasure Development
    Another essential component of the country's medical and public 
health preparedness is the capacity to make medical countermeasures to 
respond to threats. As of 15 years ago, there was no national approach 
to medicine or vaccine acquisition for civilian needs in emergencies. 
Since then, there has been substantial progress. There are now: a 
research program at NIH; an advanced development program at BARDA; an 
FDA program dedicated to medical countermeasure approval and regulatory 
science; engagement of the biopharma companies which develop and 
manufacture needed products; and, a substantial stockpile of medicines 
in the National Pharmaceutical Stockpile.
    But we need to keep strengthening and sustaining this medical 
countermeasure research, development and stockpiling system. It is a 
very challenging mission primarily because of the complexity of the 
science and the breadth of the needs. It is also difficult because--
outside of the U.S. government and sometimes other governments or 
international organizations----there are no commercial markets for most 
of these products. So the country relies on this system to prepare for 
a range of biological, chemical and radiological threats.
    There are a number of things about medical countermeasure 
development that are worth special mention. We have to press forward on 
new approaches to flu vaccine. We certainly need to forge ahead as 
rapidly as is possible in the development of a universal flu vaccine 
which could provide broad coverage to the range of flu threats that 
could face the country. But our best flu scientists say that there are 
major technical challenges in that pursuit, and that it will take time 
to develop a universal flu vaccine, no matter how we approach it. So in 
the meantime, we need to do all we can to improve the flu vaccine 
approaches that are now available.
    For instance, we still rely on eggs to produce annual flu vaccine 
as we have for years. We do this even though we have the technology to 
produce vaccine using modern recombinant techniques. Using new 
production approaches would allow us to accelerate our response in the 
event of a flu pandemic. It would also lessen the chances the vaccine 
strains could drift to become less effective in the manufacturing 
process as can happen in the process that relies on eggs.
    In the event of the onset of a pandemic flu, the USG working with 
its biopharma company partners have a plan that will take 5 to 6 months 
to begin delivering the needed flu vaccine for that pandemic. We should 
continue to exercise and support that plan and work to accelerate that 
timeline. But at least in the case of flu, we do have targets and an 
exercised process to go from new pandemic discovery to vaccine 
manufacturing in 6 month timeline. We don't have that kind of process 
for epidemics that might be caused by other pathogens.
    For example, during the Ebola outbreak in West Africa, a new Ebola 
candidate vaccine was developed, but it took so long that it was not 
available until after the outbreak was over. And in some ways, we were 
better positioned to respond to Ebola than we would be for many other 
diseases--there had been substantial science efforts related to early 
Ebola countermeasure development in DOD and NIH programs for years. For 
other infectious diseases, we would be further behind at the start, and 
it could take much longer than it did for Ebola.
    As per the November 2016 PCAST report to the President on How to 
Protect Against Biological Attack recommended, the country should set a 
national target of 6 months or less for developing a new medicine or 
vaccine for major epidemics and pandemics beyond pandemic influenza. To 
do that would require people, systems and infrastructure dedicated to 
that goal within government, and a budget to go with that. Right now 
when new epidemics emerge that require a sudden start of a new MCM 
program (e.g. Zika), it is almost guaranteed to be a long, uncertain, 
and complicated process with no clear or well worked-out pathways. In 
the case of Zika, a major company that was developing the vaccine 
ultimately dropped out of the process, in part because of the 
challenges of working with the government.
                  Potential Pandemic Pathogen Research
    It is also important for the medical and public health preparedness 
community to pay attention to the kinds of new threats that could 
inadvertently come from biological research. For example, it was 
announced last month that the USG moratorium for funding potential 
pandemic pathogen (PPP) research is over. It is possible once again to 
apply for USG funding to study ways of making the world's most lethal 
viruses (like H5N1), respiratory transmissible (like seasonal flu). In 
the worst case, this could lead to the accidental or deliberate release 
of a novel strain of virus that could cause an epidemic, or even a 
pandemic. I don't believe the benefits of this kind of research are 
worth the risks of doing it. But since the end of the moratorium has 
occurred, I would make a number of recommendations regarding this 
program.
    There should be transparency in how the government approaches this 
research. Agencies that fund this work should make their processes 
public. What PPP experiments are being proposed? How were risks and 
benefits determined, what experiments were approved, and which were 
denied? What kind of biosafety and biosecurity will be required to do 
this work? There should be clarity regarding the special review process 
that has been established to handle this research. How will it work? 
Who will be involved? How to avoid conflicts? Are there red-lines that 
should not be crossed by scientists?
    What will the international approach be? It is good that U.S. has 
taken a lead in formulating new PPP framework given that the USG 
provided the majority of government funding to date for this kind of 
work. Since the USG has acknowledged there are high risks in PPP, what 
will USG do internationally to help establish norms for this? What will 
our reaction be if we learn that other countries are pursuing PPP 
research? I disagree that the U.S. should be pursuing this work, but if 
the U.S. is going to do it, then it should be working to engage other 
countries to try to establish rules of the road regarding under what 
conditions it will be done.
                     Global Health Security Agenda
    A final element to note in medical and public health preparedness 
is the importance of international programs in preventing the emergence 
of major outbreaks that have the chance to spread to the U.S.. In 2014, 
the U.S. helped to launch the Global Health Security Agenda (GHSA) to 
improve the capacity of countries around the world to prevent, detect 
and respond to infectious disease threats. One lesson from Ebola was 
that we have to do more to help countries control infectious diseases. 
Because of that experience and because so many other countries were 
having trouble building basic capacity to detect and respond to 
infectious diseases, the U.S. made a $1Billion commitment to the GHSA 
for a period of 5 years. Other countries have also been big supporters 
of this effort. South Korea has pledged to spend $100 million to build 
capacities in 13 countries. Japan and Australia have pledged $40 
million and $100 million, respectively.
    With U.S. GHSA funds, the CDC and USAID have been working to 
improve these capabilities in 39 countries around the world. These 
programs work to diminish antimicrobial resistance, increase laboratory 
and surveillance capacities, improve vaccination rates, strengthen the 
public health workforce, and much more.
    But at this point the future of the GHSA is uncertain. Even though 
a number of senior officials in the Administration have voiced support 
for the GHSA, and signed onto a declaration to extend the GHSA for 
another 5 years, U.S. funding for the initiative is ending soon, and no 
commitment for future financial support has been made. Without any sign 
that funding will be continued, CDC has notified countries that it will 
begin planning to shut down those programs. And if we pull away from 
the GHSA in this way, other countries that provide funding and 
technical assistance will also likely do the same.
    U.S. leadership in the GHSA not only has the advantage of improving 
the capabilities of countries to prevent, detect and respond to 
infectious diseases. It is also, as U.S. Secretary of State Tillerson 
said last year, vital to U.S. national security interests. If 
vulnerable countries (many of which are either politically or 
financially unstable) do not have the capacity to quickly cope with 
disease outbreaks, those outbreaks are more likely to spread 
internationally, including to the U.S.. The GHSA is a powerful tool for 
helping to ensure that global gaps in health security are addressed 
before disease outbreaks occur. To continue the pace of U.S. efforts 
for the GHSA set by the original U.S. investment and programs, an 
estimated $100M to $200M annually would be needed. It is important for 
the United States to commit to support the GHSA to help protect the 
Nation and the rest of the world from epidemic disease. Over time, as 
countries build their own capabilities, the need for the U.S. and other 
national commitments should diminish. But at this time, GHSA remains a 
central element in building international capability to prevent, detect 
and respond to epidemic diseases.
                                 ______
                                 
    Senator Burr. Thank you, doctor.
    John.

      STATEMENT OF JOHN J. DREYZEHNER, M.D., MPH, FACOEM, 
  COMMISSIONER, TENNESSEE DEPARTMENT OF HEALTH, NASHVILLE, TN

    Dr. Dreyzehner. Good morning, Chairman Alexander, Senator 
Burr, Senator Casey, and distinguished Committee Members.
    Thank you for this opportunity to appear before the 
Committee and to discuss an initiative of significant 
importance to the common defense of this country; a strong, 
agile, and resilient public health and medical preparedness and 
response system.
    It is an honor to be here.
    Senator Alexander said I am a physician. I am the 
Commissioner of the Health in Tennessee. I was a local health 
director in central Appalachia for a decade before that and an 
Air Force flight surgeon for many years before that as well.
    The thoughts I will be sharing with you today are my own, 
but I am confident that they are shared by my public health 
colleagues across the country who strive every day to prepare 
and respond to threats of all kinds. These threats may be 
infectious disease outbreaks like measles, food borne illness, 
and our annual epidemic of seasonal influenza that can, like 
this year, unpredictably test our Nation's response readiness 
and surge capacity.
    These threats can be also large scale national or global 
events like an influenza pandemic, Ebola, Zika, the opioid 
epidemic, or acts of terrorism.
    Public health also mobilizes, as you know, during natural 
disasters like winter storms, hurricanes, tornadoes, floods, 
wildfires as Senator Alexander mentioned, and other extreme 
weather events. Unfortunately, seldom does a public health 
jurisdiction of any size go more than a few years without 
experiencing it.
    As well, through mechanisms like the Emergency Management 
Assistance Compact, or EMAC, even unaffected jurisdictions are 
frequently called upon to assist neighbors.
    Public health, and emergency preparedness response and 
recovery, is a responsibility, discipline, and service that we 
have to get right. Lives, as well as physical and economic 
health, depend on it. It is something we, in public health, do 
every day. It is a matter of local resiliency. All disasters 
play out locally and it is also a matter of national security.
    In the few moments that we have together, I would like to 
share my perspective with you, having been directly involved in 
the planning, implementation, and execution roles at all levels 
both in the military and civilian capacity over 25 years. Let 
me start with a simple question.
    What is health and medical emergency preparedness response 
and recovery?
    At root, it is not stuff, or equipment, or plans. It is 
people. Shelters do not staff themselves. A fire truck cannot 
put out a fire without firefighters. And people, like public 
health nurses or firefighters, cannot be hired and trained 
after the alarm sounds. They need to be there, ready to go, 
before the threat ever emerges if they are to be effective in 
responding to it. Preparedness is about the people involved and 
their interconnected networks.
    To be truly prepared, we need three key things.
    One, trained people, some with local knowledge and all 
connected by relationships built on trust;
    Two, expertise and leadership at all levels, local, state, 
and Federal, and;
    Three, communication and shared situational awareness among 
responding leaders, people on the ground, and experts.
    Trying to create these three things after an event begins 
takes the one commodity that is most precious in an emergency: 
time. We do not have time to create this network after the 
event starts.
    In a way, the public health, and emergency preparedness, 
response and recovery network is like afor a performer. It has 
to be in place before the show starts, anchored, inspected and 
in good shape to do the job.
    Many people think equipment or supplies are the net, but if 
you remember nothing else from my testimony today, I would like 
you to remember this. People, not things, are the net. People 
are the net. The anchors matter, but it is the people that run 
the response. The relationships, the knowledge, and the trust 
created over time are what strengthen the cords, hold them 
together, and keep them adaptable and resilient. The more that 
cords and nodes on the net degrade or unravel, the less capable 
the net is for what we need it to do at our most vulnerable 
times.
    Things like durable medical equipment, medical 
countermeasures, and communications infrastructure are 
essential anchors for the net. Without them, the network of 
people cannot be as effective, but the people are the net.
    Our accomplishments and successes in preparedness response 
and recovery over the last 15 years, which I have illustrated 
in my written remarks, can be directly attributed, I believe, 
to the Pandemic and All-Hazards Preparedness Act.
    This Act, both in its initial and first authorization form, 
was transformative relative to public health and healthcare 
preparedness, and has provided the requisite direction 
authorities, the authorization of resources, and the cadence of 
accountability that has become part of the culture of public 
health, and enable us to do our job in the best way possible.
    As you consider PAHPA reauthorization, PHEP and HPP 
priorities and resources must be lined up with the demands of 
an ever expanding threat environment, given our frontline of 
defense and safety net ability. The scale and speed it needs to 
protect the public's health and safety are critical to this 
ability.
    Congress, and especially this Committee, should be 
applauded for its continued work on laws like PAHPA that give 
states, territories, localities, and tribes the resources and 
tools needed to stay vigilant at this critical post and get the 
job done. These funds are not duplicative of emergency 
management and Homeland Security, as you know, but 
complementary and essential. Sometimes, depending on the 
hazard, public health is the only responder.
    What we ultimately need as a Nation to ensure a strong 
safety net is consistent, reliable, and sufficient funding to 
keep the people, the net, their knowledge, their networks, and 
their trust intact.
    Thank you, again, for the opportunity to speak with you 
today about this fundamental issue and for caring about 
preserving our ability to respond to any hazard or threat for 
generations to come.
    I appreciate the opportunity to present to you. Thank you.
    I am happy to take questions.
    [The prepared statement of Dr. Dreyzehner follows:]
                 prepared statement of john dreyzehner
    Chairman Alexander, Ranking Member Murray, Senators Burr and Casey, 
and distinguished Committee Members. Thank you for this opportunity to 
appear before this Committee today to discuss an issue of significant 
importance to the common defense of the country--a strong, agile, and 
resilient public health and medical preparedness and response system. 
It is an honor to be here. The thoughts I will be sharing with you 
today are my own, but I am confident that they are shared by my public 
health colleagues across the country who strive every day to prepare 
for and respond to threats of all kinds. These threats may be 
infectious disease outbreaks like measles, food borne illness, and our 
annual epidemic of seasonal influenza that can, like this year, 
unpredictably test our Nation's response readiness and surge capacity. 
These threats can also be large scale national or global events like an 
influenza pandemic, Ebola, Zika, the opioid epidemic, or acts of 
terrorism. Public health also mobilizes during natural disasters such 
as winter storms, hurricanes, tornados, floods, wildfires, and other 
extreme weather events that, unfortunately, seldom does a public health 
jurisdiction of any size go more than a few years without experiencing. 
Through mechanisms like the Emergency Management Assistance Compact, or 
EMAC, even unaffected jurisdictions are frequently called upon to 
assist neighbors.
    Public health and medical emergency preparedness, response, and 
recovery is a responsibility, discipline, and service that we must get 
right; lives, as well as physical and economic health depend on it. It 
is something we in public health do every day, it is a matter of local 
resiliency, as all disasters play out locally, and it is a matter of 
national security. In the few moments we have together, I would like to 
share my perspective with you, having been directly involved in 
planning, implementation, and execution roles at all levels, both in a 
military and civilian capacity, for over 50 years.
    Let me start with a simple question: ``What is health and medical 
emergency preparedness, response, and recovery?'' At root, it's not 
``stuff'' or equipment or plans. It's people. Shelters don't staff 
themselves. A fire truck can't put out a fire without firefighters, and 
people, like public health nurses or firefighters, can't be hired and 
trained after the alarm sounds. They need to be there, ready to go 
before the threat ever emerges if they are to be effective in 
responding to it.
    Preparedness is about the people involved: It is about their 
interconnected networks. To be truly prepared we need three key things: 
(1) Trained people, some with local knowledge, and all connected by 
relationships built on trust, (2) Expertise and leadership, at all 
levels; local, state, and Federal and (3) Communication and shared 
situational awareness among the responding leaders and experts. Trying 
to create these three things after an event begins takes the one 
commodity that is most precious in an emergency: Time. We don't have 
time to create this network once the event starts.
    In a way, the public health and medical emergency preparedness 
response and recovery network is like a safety net for a performer--it 
has to be in place before the show starts, anchored, inspected, and in 
good shape for it to do its job. Many people think equipment or 
supplies are the net, but if you remember nothing else from my 
testimony today, please remember this: people, not things, are the net. 
The relationships, knowledge, and trust created over time are what 
strengthen the cords, hold them together and keep them adaptable and 
resilient. The more the cords and nodes on the net degrade or unravel, 
the less capable the net is for what we need it to do at our most 
vulnerable times. Things, like durable equipment, medical 
countermeasures, and communications infrastructure, are essential 
anchors for the net. Without them, the network of people can't be as 
effective, but it's the people who are the net.
    Our accomplishments and successes in preparedness, response, and 
recovery over the last 15 years (illustrated in my written remarks) can 
be directly attributed to the Pandemic and All Hazards Preparedness 
Act. This Act, both in its initial and first reauthorization form, was 
transformative relative to public health and healthcare preparedness 
and has provided the requisite direction, authorities, authorization of 
resources, and cadence of accountability that have become part of the 
culture of public health and enable us to do our job in the best way 
possible.
    As you consider PAHPA reauthorization, PHEP and HPP1 priorities and 
resources must line up with the demands of an ever-expanding threat 
environment and give our frontline of defense and safety net the 
ability, the scale, and the speed it needs to protect the public's 
health and safety. Congress, and especially this Committee, should be 
applauded for its continued work on laws like PAHPA that give states, 
territories, localities, and tribes the resources and tools needed to 
stay vigilant at this critical post and get the job done when needed. 
These funds are not duplicative of emergency management and Homeland 
Security, but complementary and essential. Sometimes, depending on the 
hazard, public health is the only responder.
    What we ultimately need as a nation to ensure a strong safety net 
is consistent, reliable, and sufficient funding to keep the people, the 
net--their knowledge, networks, and trust--intact.
    1 Public Health Emergency Preparedness (PHEP) Cooperative Agreement 
& Hospital Preparedness Program (HPP)
    Thank you again for the opportunity to speak with you today about 
this fundamental issue and for caring about preserving our ability to 
respond to any hazard or threat for generations to come.
    State and territorial public health departments play a critical 
role in national security and have increased their individual and 
collective capacity, capabilities, and impact over the last 15 years to 
manage the consequences of local, regional, and national emergencies 
more effectively, saving lives and preventing or reducing injury and 
illness. These accomplishments are due, in large part, to the 
leadership, strategy and policy provided, and the investments by the 
Federal Government in state and local partners, to build and sustain a 
strong public health and medical preparedness system--both a front-line 
defense and a safety net. Our accomplishments and successes can be 
directly attributed to the Pandemic and All Hazards Preparedness Act. 
This Act, both in its initial and first reauthorization form, was 
transformational as it pertains to public health and healthcare 
preparedness and has provided the requisite direction, authorities, and 
authorization of resources to enable us to do our job in the best way 
possible.
    In Tennessee, our front line of defense and safety net is very 
adaptable. We have deployed it recently for fires, floods, for winter 
storms, wind and tornado events, and to provide mutual aid to 
neighboring states and those as far away as the US Virgin Islands. The 
list continues with other hazards like Ebola, Zika, measles and mumps 
outbreaks, foodborne illnesses, the fungal meningitis associated with 
contaminated compounded injectable drugs which I will come back to in a 
few moments, and ``white powder'' incidents. These are real and often 
different threats requiring flexible and adaptable response 
capabilities. In each instance, the strength of our system is tested, 
and each time we assess our performance with a commitment to learn from 
each and every experience and to make improvements so that our actions 
will be even stronger the next time.
    Among other features, the Pandemic and All Hazards Preparedness Act 
created and authorized two critically important, aligned and 
coordinated programs: The Public Health Emergency Preparedness Program 
administered by the CDC and the Hospital Preparedness Program 
administered by the HHS Assistant Secretary for Preparedness and 
Response. These two programs are the bedrock for state and local public 
health preparedness and response providing essential cooperative 
agreement funding as well as guidance and technical assistance. They 
not only enable jurisdictions to plan, train and exercise, but also to 
purchase laboratory and communications equipment, medical 
countermeasures, and personal protective equipment for first 
responders. More importantly, it allows public health departments to 
hire and retain a skilled workforce and to make a long-term investment 
in ``people'' such as epidemiologists, laboratory technicians, nurses, 
environmental health specialists and other subject matter experts. It 
is the people, their networks, expertise, and relationships built on 
trust that are truly the safety net.
    Eighty-one percent of Tennessee's Public Health Emergency 
Preparedness (PHEP) program award goes to personnel costs. I realize 
this is not an appropriations Committee hearing today but I would be 
remiss if I did not mention that the aforementioned funding is 
essential, but not sufficient. The primary source for state and local 
public health preparedness has been cut by about one-third (from $940 
million in 2002 to $667 million in 2017) and hospital emergency 
preparedness funds have been cut in half ($514 million in 2003 to $254 
million in 2017). These reductions have degraded the safety net and our 
resiliency as a nation in the face of these ongoing and increasing 
threats. This is a high value investment in the health, safety, and 
security of our homeland, and returning to these earlier levels of 
funding is a relatively small investment that could reap billions of 
dollars in savings given the potentially high cost it could take to 
respond to an unmitigated disaster or pandemic. Having the resources to 
get it right rapidly at the local level is far more effective and less 
costly than a poorly coordinated response that would require Federal 
intervention. As you consider PAHPA reauthorization, funding 
authorization levels for both PHEP and HPP must line up with resource 
demands of today and into the future to sufficiently handle the ever-
expanding threat environment and to give our frontline of defense and 
safety net the ability, the scale and the speed it needs to protect the 
public's health. It is important to understand that public health 
emergency preparedness and response infrastructure is people. One can 
think of it in terms of three tiers of public health responders: (1) 
Emergency preparedness professionals, (2) those who have deep emergency 
preparedness training but whose daily duties are more in line with 
traditional public health work, and (3) all other public health 
professionals like public health nurses who stand ready to assist when 
needed. Each of these tiers, while they may have differing levels of 
direct involvement in responding to threats, are all essential to 
enabling a fully functional net and all must work together when needs 
arise to support each other.
    Using just two examples in my own State of Tennessee, a strong 
public health response was crucial in saving lives during the 2016 wild 
fires in Sevier County that impacted the beautiful town of Gatlinburg. 
In addition to staffing shelters, providing vaccines and care, tracking 
down and accounting for missing persons, providing for the decedents, 
assuring food safety, testing water, staffing of local, regional, and 
state emergency operations centers around the clock, the Tennessee 
Department of Health (TDH) trailers served as the communications hub 
for multiple other agencies including the hospital, EMS, and 911 
system. We were all part of the same team, and having the proper 
resources deployed at the right place and time saved lives and 
property.
    During the fungal meningitis outbreak of 2012 that led to 751 cases 
across 20 states, with 64 total deaths nationwide, the TDH leveraged a 
PHEP-funded communication system called the Tennessee Countermeasure 
Response Network to integrate public health in this unprecedented 
response that included public health and healthcare sectors. It was 
Tennessee's leadership that pinpointed the source of the outbreak and 
helped to identify patients at risk. Relationships and trust built 
between TDH and Tennessee healthcare providers and other public health 
agencies and, most critically, the relationships between public health 
nurses and the victims of this terrible event themselves, enabled a 
swift and coordinated response. The outbreak response was concluded in 
4 months (though the suffering of the victims in some cases continues), 
and the rapid identification and response eliminated further exposure 
and cases.
    These incidents could have been far worse if it were not for the 
preparedness efforts of the public health and medical systems. 
Similarly, I am confident that my colleagues like Dr. John Wiesman in 
Washington State when responding to the tragic train derailment last 
December or Danny Staley in North Carolina recently responding to 
extreme winter weather, do not want to know how their experiences could 
have evolved without the critical support from the Federal Government 
for public health preparedness efforts. Each of these examples, and I 
can certainly provide you with many more, demonstrates a return on the 
investment. That being said, we must also remember that the system 
built on passionate, compassionate public health professionals can 
degrade quickly if not maintained and the investment continually 
renewed.
    In closing, allow me to reemphasize the point that the Pandemic and 
All Hazards Preparedness Act (PAHPA) is the mechanism that undergirds 
the Federal, state, and local governments in these efforts. It is an 
extremely important and proven piece of legislation that is responsible 
for transforming public health preparedness over what is approaching 
two decades and is paramount as it pertains to our ability to protect 
the public's health from a constant, challenging, and changing threat 
landscape. Congress, and especially this Committee, should be applauded 
for its continued work on laws like PAHPA that give states, 
territories, localities, and tribes the resources and tools needed to 
get the job done. These funds are not duplicative of emergency 
management and Homeland Security, but complementary and essential.
    As you consider suggestions for the refinement and enhancement of 
PAHPA, I respectfully submit the following principles to consider:

      Preparedness Programs should be nationwide and extreme 
care should be given not to change the funding formula or criteria that 
would result in reduced or eliminated funding to jurisdictions thus 
compromising their preparedness and response capacity and capability; 
all states and localities need their neighbors to be as strong as they 
are,
      I mentioned previously Preparedness Programs should be 
authorized at sufficient funding levels to strengthen and maintain 
support for public health infrastructure and workforce; to retain this 
highly trained and effective workforce, they need to have some 
reasonable certainty regarding continuity in the Nation's need and wish 
for their professional activities; these people form the core of the 
safety net,
      We need a viable Immediate Response Fund allowing for the 
timely infusion of additional resources to support surge when existing 
capacity is or will soon be exceeded. This principle is well understood 
and used routinely by other first responders dealing with natural 
disasters. A current fund already exists but is not truly funded. The 
practice community would gladly work with the Committee and others to 
identify those ``triggers and guardrails'' to be expressed in statute 
possibly through this reauthorization cycle that will give Congress the 
necessary comfort and confidence of stewardship to then appropriate 
reasonable and necessary funds for future use, and
      Strengthen the Public Health Emergency Medical 
Countermeasures Enterprise (PHEMCE) strategy and implementation plan 
process to require coordination with state and local entities to ensure 
the products being developed reach the end users in a timely and well-
coordinated manner.

    Thank you again for your attention today and for caring deeply 
about our Nation's emergency preparedness, response, and recovery 
system for today and tomorrow.
                                 ______
                                 
    Senator Burr. Thank you, John.
    Brent, the floor is yours.

STATEMENT OF BRENT MACGREGOR, SENIOR VICE PRESIDENT, COMMERCIAL 
   OPERATIONS, SEQIRUS; CO-CHAIR, ALLIANCE FOR BIOSECURITY, 
                           SUMMIT, NJ

    Mr. MacGregor. Good morning, Senator Burr, Senator Casey, 
and Members of the Committee.
    My name is Brent MacGregor and I am the Senior Vice 
President of Commercial Operations for Seqirus.
    I appreciate the opportunity to appear before you today as 
you prepare to consider the second reauthorization of the 
Pandemic and All-Hazards Preparedness Act.
    I would like to focus my remarks on the importance of 
preparedness against pandemic influenza and the critical role 
played by the Biomedical Advanced Research and Development 
Authority, BARDA, and its industry partners.
    There are three issues that I would like to highlight from 
my written testimony.
    First, that pandemic influenza is one of the most urgent 
public health threats we face as a Nation and must be a 
priority of HHS's biodefense enterprise.
    Second, BARDA's pandemic influenza program must finally be 
authorized in this year's PAHPA legislation.
    Third, that Congress must provide sustained, and 
predictable, MCM funding to strengthen partnerships with the 
private sector and ensure our Nation's preparedness.
    Now, regarding my first point, preparing against pandemic 
influenza, this is critical to our national and economic 
security. Seqirus is proud of the partnership we have with 
BARDA to supply one-third of the Nation's vaccine needs when 
the next pandemic strikes.
    Thanks to the leadership of Senator Burr and Senator Casey, 
and Members of this Committee, and the dedicated team at BARDA, 
our state-of-the-art vaccine production facility in Holly 
Springs, North Carolina is one of the best examples of a 
successful public-private partnership in biodefense.
    Second, regarding BARDA's pandemic influenza program, 
despite representing the ``P'' in PAHPA, authorized funding for 
pandemic influenza has never been included in the legislation. 
As a result, funding for critical BARDA activities, such as 
vaccine stockpiling, advanced research and development, has 
been largely episodic since 2009. Emergency supplemental funds 
provided during the 2005 and the 2009 pandemics are now fully 
exhausted.
    Having a program authorized by Congress will provide a 
clear signal to the private sector that the U.S. Government is 
committed to preparing against pandemic threats in the future.
    BARDA's most recent 5-year budget outlined $630 million in 
pandemic influenza funding needs for Fiscal Year 2019 alone. We 
believe an annual authorization level of at least $535 million 
is needed to support HHS's most critical pandemic influenza 
activities.
    Finally, regarding sustained and predictable MCM funding, 
over the last 12 years, this enterprise has greatly improved 
our Nation's security. And while BARDA has improved its 
communication with industry partners, better reporting from the 
Government could provide more end to end certainty in the MCM 
development process.
    Procurement funding provided by the Project BioShield 
Special Reserve Fund, the Strategic National Stockpile, and 
BARDA's pandemic influenza program provides manufacturers in 
the market certainty after investing for many years in R&D.
    Because there is no commercial market for MCM's, companies 
like Seqirus can only rely on the commitments provided by HHS 
to make investments in MCM research. Unfortunately, over the 
last several years, the private sector has become more 
skeptical of the Government's commitment to biodefense. The 
lack of multiyear funding for the SRF has created uncertainty 
in the long term sustainability of MSM programs. Public-private 
partnerships must be sustained over time through a demonstrated 
commitment by the Federal Government.
    There are dozens of companies, both large and small, that 
have committed to BARDA's mission and made significant new 
investments in MCM development. Reauthorization of PAHPA's 
authorities and a renewed commitment to MCM funding will ensure 
these investments yield even more FDA approved medical 
countermeasures.
    Seqirus strongly supports the PAHPA reauthorization 
priorities identified by the Alliance for Biosecurity, to which 
I am privileged to be a co-chair, and by the Biotechnology 
Innovation Organization, or BIO.
    I would like to thank Members of this Committee, and in 
particular, Senator Burr, for their commitment to reauthorizing 
PAHPA in a timely manner. Seqirus believes tremendous progress 
has been made to ensure Americans are better protected against 
the threat of pandemic influenza, and we are excited about the 
future of our partnership with BARDA.
    We strongly encourage the Committee to formally authorize 
BARDA's pandemic influenza program. This is a critical 
opportunity for Congress to ensure BARDA has the resources it 
needs to prepare against one of the most predictable threats we 
face as a Nation.
    I look forward to serving as a resource for this Committee 
during the PAHPA reauthorization process.
    I am happy to answer any questions you may have, and I 
thank you for inviting me here today.
    [The prepared statement of Mr. MacGregor follows:]
                 prepared statement of brent macgregor
    Good morning Mr. Chairman, Ranking Member Murray, and Members of 
the Committee. My name is Brent MacGregor and I am the Senior Vice 
President of Commercial Operations for Seqirus. I appreciate the 
opportunity to appear before you today as you prepare to consider the 
second reauthorization of the Pandemic and All Hazards Preparedness Act 
(PAHPA). I would like to focus my remarks on the importance of 
preparedness against pandemic influenza and the critical role played by 
the Biomedical Advanced Research and Development Authority (BARDA) and 
its industry partners.
    Seqirus is a global leader in the development and manufacturing of 
influenza vaccines. With extensive research and production expertise 
and facilities in the U.S., U.K. and Australia, Seqirus is a committed 
partner in pandemic preparedness and a major contributor to the 
prevention and control of influenza globally. Seqirus' influenza 
vaccine business comprises a workforce of over 3,000 employees, 
significant manufacturing capacity, a commercial presence in 20 
countries, and product and geographic diversity. We are the only 
influenza vaccines manufacturer with the flexibility of two scaled up 
production technologies, including, cell-based vaccines.
    Our long-established parent company, CSL Limited, has a rich 
heritage in influenza dating back to the Spanish flu pandemic. As you 
may know, this year marks the 100th anniversary of the 1918 pandemic, 
which killed more than 50 million people and represents one of the 
deadliest natural disasters in human history. It is especially timely 
for this Committee to be considering how the U.S. can be better 
prepared against pandemic influenza in the future.
    I would like to highlight Seqirus' state-of-the-art vaccine 
production facility in Holly Springs, North Carolina. Thanks to the 
leadership of Senator Burr, Members of this Committee, and the 
dedicated team at BARDA, we believe the Holly Springs facility is one 
of the best examples of a public-private partnership envisioned by the 
authors of PAHPA when it was originally signed into law in 2006.
    I would also like to highlight Seqirus' proprietary adjuvant MF59 
which boosts response, and broadens vaccine match as well as enabling 
dose-sparing of vaccine antigen. MF59 is a cornerstone of broader 
access to pandemic influenza vaccines and part of BARDA's pandemic 
preparedness and response stockpiling strategy. We believe it is 
critical to manage MF59 as a long term asset within the pandemic 
preparedness enterprise which means that it needs a life cycle 
management strategy consistent with industry standards.
    We are currently working with BARDA to manufacture candidate 
vaccines against the H7N9 strain circulating in China. Last week, 
testifying before this committee, the Assistant Secretary for 
Preparedness and Response, Dr. Kadlec, highlighted his concern with the 
ominous trends that they are seeing with the evolution of the H7N9 
strain.
    Seqirus believes it is critical that PAHPA be reauthorized in a 
timely manner to ensure BARDA has the resources it needs to continue 
its unique national security mission at the Department of Health and 
Human Services (HHS). We also strongly believe that the Committee's 
reauthorization of PAHPA should finally include an authorization of 
BARDA's pandemic influenza program. Despite representing the ``P'' in 
PAHPA, authorized funding for pandemic influenza preparedness has never 
been included this legislation.
    Similar to medical countermeasures against chemical, biological, 
radiological, and nuclear (CBRN) threats, there is no commercial market 
for pandemic influenza vaccines. Seqirus relies on our partnership with 
the U.S. Government to make continued investments in research, 
development, infrastructure, and vaccine production. Authorizing 
BARDA's pandemic influenza program and providing robust, sustained 
annual funding for the program would send a clear signal to the private 
sector that the United States is committed to preparedness against 
pandemic influenza.
    Seqirus also supports the PAHPA reauthorization priorities 
identified by the Alliance for Biosecurity, to which I am privileged to 
be a Co-Chair, and by the Biotechnology Innovation Organization (BIO). 
These priorities include multi-year funding for the Project BioShield 
Special Reserve Fund (SRF) and increased funding for BARDA's advanced 
research and development programs, including for emerging infectious 
diseases and antibiotics. Finally, I would like to thank the members of 
this committee for all the work they have done to support HHS' 
preparedness enterprise since the last PAHPA reauthorization, including 
making important changes to BARDA's contracting process in last year's 
21st Century Cures Act.
    PAHPA has been a success since it was first passed by Congress in 
2006. The biodefense enterprise created at HHS over the last 12 years 
has greatly improved our Nation's security. From the perspective of a 
manufacturer, this enterprise has made it more attractive to invest in 
partnerships with the U.S. Government. However, there are areas where 
the medical countermeasure (MCM) enterprise could be improved.
    At the beginning of this process, industry partners with the 
National Institutes of Health (NIH) to conduct basic research and 
discovery. These public and private investments often yield promising 
MCM candidates which can progress to advanced development with BARDA. 
While BARDA has improved its communication with industry partners to 
ensure smooth transitions, better coordination and communication within 
the government could improve the ability to provide end-to-end 
certainty to government partners. In recent years, BARDA has focused on 
the promise of platform technologies which can speed up development 
timelines and provide rapid response capabilities in an outbreak.
    Because there is no commercial market for MCMs, the procurement 
funding provided by the Project BioShield Special Reserve Fund (SRF), 
the Strategic National Stockpile (SNS) and BARDA's pandemic influenza 
program provides manufacturers with market certainty after investing 
for many years in research and development. However, the lack of multi-
year funding has created uncertainty in the long term sustainability of 
some medical countermeasures programs. And importantly, the Food and 
Drug Administration's (FDA) dedication to addressing the unique 
challenges of MCM development has given companies confidence that MCM 
candidates can ultimately gain licensure. FDA approval is an important 
milestone for companies and a key public health goal for the 
government.
    Of course, this process is not perfect and can certainly be 
improved. The overall structure created by PAHPA has enabled dynamic 
public-private partnerships to thrive, but these partnerships must be 
sustained over time through a demonstrated commitment by the Federal 
Government.
    Seqirus is just one example of how a partnership with BARDA could 
be successful in the pandemic influenza space. There are dozens of 
other companies--both large and small--that have committed to BARDA's 
mission and made significant new investments in MCM development. 
Reauthorization of PAHPA's authorities and a renewed commitment to MCM 
development funding will ensure these investments yield even more 
approved MCMs.
                    The Threat of Pandemic Influenza
    As Members of this Committee know well, one of the most urgent 
public health threats we face as a nation is pandemic influenza, a 
constantly changing global viral threat. It is often forgotten that the 
2009 H1N1 pandemic, a relatively mild pandemic, killed more than 12,000 
Americans and hospitalized 300,000 more. The cost to our citizens, our 
economy, and our security was incredibly high. It is not a matter of 
if, but when, the next pandemic strikes.
    Pandemic influenza is not just a public health threat; it is indeed 
a national security threat. Ensuring we are prepared to respond to an 
influenza pandemic is critical to our national and economic security. 
The World Bank has estimated that a severe global influenza pandemic 
could cost nearly 5 percent of global GDP.
    To be ready when a pandemic is declared, we have to invest in R&D 
for new and better influenza vaccines, to invest in, and sustain, the 
manufacturing surge capacity to rapidly produce more than 600 million 
doses of matched virus--two for every American, and we have to maintain 
stockpiles of vaccine against circulating pre-pandemic strains so we 
can protect first responders and essential personnel during the time it 
takes to manufacture matched vaccine.
    Pandemic influenza is related to seasonal influenza, but is also 
different in many significant ways. Most importantly, new pandemic 
influenza strains show up across the globe in real-time, emerging from 
animal to human transmission of strains new to our immune system. 
Because there is no commercial market to develop vaccines against these 
new pandemic strains, the U.S. Government must work with private sector 
partners to ensure vaccines against these strains are available if an 
outbreak occurs. This process of developing pandemic influenza vaccines 
requires a robust partnership between the government and the private 
sector. We are proud of our decade-long partnership with BARDA to 
ensure the United States is prepared to respond to a pandemic influenza 
outbreak.
    Unfortunately, funding for preparedness against pandemic influenza 
threats has been episodic since 2009. The vast majority of funding 
provided to the Department of Health and Human Services (HHS) for 
pandemic influenza was in emergency supplemental legislation during the 
2004, 2005, and 2009 outbreaks. These emergency funds helped stand up 
critical response efforts at HHS, but are now fully exhausted. Since 
that time, annual funding for HHS' pandemic influenza readiness 
programs have dramatically declined. It is critical that our domestic 
influenza manufacturing capabilities are strengthened and sustained, 
and private sector partners see a renewed commitment from Congress and 
HHS.
           Seqirus' Pandemic Influenza Partnership With BARDA
    In 2007, BARDA partnered with Seqirus (then Novartis) in the 
construction of a new influenza vaccine manufacturing facility in Holly 
Springs, North Carolina. Seqirus currently has several contracts with 
HHS to (1) complete advance stage development of antigen-sparing 
capability for pandemic influenza vaccination; (2) facilitate domestic 
vaccine capability with more rapid response and with greater surge 
capacity in the event of an influenza pandemic; (3) stockpile pandemic 
vaccine supplies; and (4) develop a synthetic influenza seed process 
for rapid pandemic response.
    The Holly Springs facility will quickly surge domestic production 
capacity of pandemic influenza vaccine to combat public health 
emergencies. The facility has been designed to provide pandemic 
vaccines to protect one third of the US population, within 6 months of 
the declaration of a pandemic.
    The facility employs approximately 500 high-skilled workers to 
produce both pandemic and seasonal influenza vaccines using innovative 
cell culture-based manufacturing technologies. We believe Holly Springs 
is one of the most successful public-private partnerships between 
industry and BARDA. The total investment in the facility committed by 
both Seqirus and BARDA has now surpassed $1 billion. The innovations 
developed at Holly Springs--like new, cell-based flu vaccines--are 
critical to improving U.S. preparedness.
   Seqirus is a Leader in the Development of Innovative, Cell-Based 
                         Vaccines Technologies
    How well flu vaccines work can vary from season to season. One of 
the main factors that impact flu vaccine effectiveness is the ``match'' 
between the viruses that the flu vaccine is designed to protect 
against, and the flu viruses spreading in the community.
    How closely the vaccine is ``matched'' to circulating strains can 
be impacted by changes in the circulating viruses between the time the 
influenza vaccine was manufactured and the public is vaccinated, as 
well as changes that can take place in the influenza vaccine production 
process.
    The majority of currently available influenza vaccines globally are 
manufactured using egg-based technology, and work reasonably well. 
However, the viruses used by manufacturers to start the production 
process can undergo changes when optimized for growth in eggs. When 
this occurs, the resulting vaccine may not be as closely matched to the 
circulating virus as would be preferred, which can reduce the level of 
protection against influenza infection.
    The influenza vaccine industry is pursuing several new technologies 
to improve vaccine effectiveness. One of the new technologies used by 
Seqirus is a cell-based influenza vaccine manufactured in the United 
States. Cell-based influenza vaccines are not subject to egg-adaptation 
issues, and may therefore be more closely matched to circulating 
viruses. We believe the use of cell-based influenza vaccines in future 
flu seasons and flu pandemics has the potential to significantly 
improve vaccine effectiveness, and as a result, save more lives.
 PAHPA Reauthorization Must Include BARDA's Pandemic Influenza Program
    Over the last 13 years, Congress has passed three separate 
emergency supplemental bills providing $13.2 billion in funding to 
respond to the threat of pandemic influenza. This funding sustained HHS 
programs to develop and purchase flu vaccines, antivirals, and 
necessary medical supplies. The funding also supported the construction 
and renovation of manufacturing facilities for the production of 
pandemic influenza vaccines to secure sufficient supplies for the U.S. 
population.
    For more than a decade, HHS has relied on and drawn down balances 
from supplemental appropriations bills to fund pandemic preparedness. 
These balances are now exhausted. Since the passage of these three 
emergency supplemental bills, sustained resources for HHS' pandemic flu 
readiness programs have dramatically declined. This has led to an aging 
stockpile that doesn't match currently circulating strains, critical 
adjuvants such as our MF59 that are expired, domestic manufacturing 
capabilities that must be sustained, and private sector partners who 
aren't sure if HHS is committed to this partnership that is so critical 
to the Nation's readiness.
    In order to successfully prepare against a future influenza 
pandemic, Seqirus believes Congress should finally enact a permanent 
authorization of BARDA's pandemic influenza program in the 
reauthorization of PAHPA. This authorization is necessary to support 
research and development of new influenza technologies, regularly test 
and evaluate rapid response capabilities for known and new pandemic 
threats, and maintain influenza stockpiles of vaccine and therapies. 
Having a program authorized by Congress will also provide a clear 
signal to the private sector that the U.S. Government is committed to 
preparing against pandemic threats.
    BARDA's most recent 5-year budget outlined $630 million in pandemic 
influenza funding needs for Fiscal Year 2019 alone. We believe an 
annual authorization level of at least $535 million is needed to 
support HHS' most critical pandemic influenza activities. These 
activities include pandemic vaccine stockpile maintenance, diagnostic 
research, infrastructure improvements, universal flu vaccines research, 
and flu therapeutic research.
                               Conclusion
    We believe tremendous progress has been made to ensure Americans 
are better protected against the threat of pandemic influenza, and 
Seqirus is excited about the future of our partnership with BARDA.
    I would like to thank Members of this Committee, and in particular 
Senator Burr, for their commitment to reauthorizing PAHPA in a timely 
manner. This is a critical opportunity for Congress to ensure BARDA has 
the resources it needs to prepare against of the most predictable 
threats we face as a Nation.
    I look forward to serving as a resource for this Committee during 
the PAHPA reauthorization process, and I am happy to answer any 
questions you may have today. Thank you.
                                 ______
                                 
    Senator Burr. Brent, thank you for that testimony.
    Steven, the floor is yours.

STATEMENT OF STEVEN KRUG, M.D., FAAP, HEAD, PEDIATRIC EMERGENCY 
   MEDICINE, ANN AND ROBERT H. LURIE CHILDREN'S HOSPITAL OF 
   CHICAGO; PROFESSOR OF PEDIATRICS, NORTHWESTERN UNIVERSITY 
   FEINBERG SCHOOL OF MEDICINE; CHAIR, DISASTER PREPAREDNESS 
 ADVISORY COUNCIL, AMERICAN ACADEMY OF PEDIATRICS, CHICAGO, IL

    Dr. Krug. Good morning, Chairman Burr, Ranking Member 
Casey, distinguished Members and staff of the HELP Committee.
    I am Dr. Steve Krug. I am the Head of the Division of 
Emergency Medicine at the Ann and Robert H. Lurie Children's 
Hospital, Chicago and Professor of Pediatrics at the 
Northwestern University Feinberg School of Medicine. I am the 
Chair of the American Academy of Pediatrics Disaster 
Preparedness Advisory Council. And on behalf of the 66,000 
Members of the AAP, thank you for holding today's hearing and 
for inviting me.
    I have also been privileged to serve on Federal Advisory 
Committees and presently as the Chair of the HSS National 
Biodefense Science Board, now known as the NPRSB. My comments 
today, however, are as a private citizen and as a member and 
leader within the Academy.
    I applaud the work of this Committee for strengthen and 
improving our Nation's public health and medical preparedness 
with the Pandemic and All-Hazards Preparedness Reauthorization 
Act of 2013. In particular, I must thank you for the first-ever 
provisions for children in the last reauthorization. Those 
changes have helped to make the needs of children a much higher 
priority in emergency planning and response.
    As we heard last week from ASPR, CDC, and FDA leadership, 
each agency has a vital and distinct role to play in ensuring 
that our healthcare system is better prepared to meet the needs 
of all Americans including, of course, children during and 
after a disaster.
    The leaders of these Federal agencies--and the countless 
hardworking, dedicated Federal employees that they oversee--
really are the backbone of our Nation's 24/7 Federal emergency 
readiness and response capacity.
    By most accounts, the frequency, severity, and cost of 
disasters and emergencies are increasing, meaning that they 
will remain a significant threat to the health and safety of 
our communities and our Nation.
    As such, maintaining and expanding the Federal Government's 
strategic focus on all hazard approaches that address both 
routine and health security related needs is critical. This 
will require continuing engagement of all stakeholders 
including public health, medical and mental health services, 
academia, industry, and day to day emergency and trauma 
services.
    Foundational elements core to preparedness, including the 
HRSA Medical Emergency Services for Children program and our 
Nation's children's hospitals, must also be strong and engaged.
    It is evident that healthcare, and other systems that are 
regularly tested, will be the most reliable and effective 
during a response. Regular exercises and drills, along with 
continuing education for care providers and first responders, 
are necessary in order to be ready for all populations when a 
disaster strikes. This is especially important if we hope to be 
ready to meet the unique needs of children.
    At a population level, we should strive for a healthier and 
more resilient community pre-disaster as this will reduce the 
burden on the healthcare system during and after disasters. 
This means ensuring access to affordable healthcare and 
preventative services, and reducing healthcare disparities in 
all populations.
    Financial drivers in today's healthcare environment are not 
aligned with the need for facilities to be prepared for public 
health emergencies. Cost reduction measures have resulted in a 
leaner stockpile of supplies, medications, and equipment and a 
substantially smaller workforce with daily operations, 
particularly inpatient operations functioning much closer to 
full capacity.
    This has promoted emergency department overcrowding, that 
is where I work, and poor surge capacity during seasonal 
epidemics and pandemics, like the one we are going through 
right now. The surge capacity gap is particularly precarious 
within pediatrics.
    Current disaster planning does not adequately integrate 
primary care. These clinicians, who largely operate as small, 
private sector businesses, provide vital services before, 
during, and then after disasters. In the absence of mechanisms 
to provide assistance to impacted providers and disrupted 
practices, many have been forced to leave.
    Given this, it is not hard to see why so many communities 
have struggled to respond and why so many never fully recover 
after a disaster. Community resilience relies heavily upon the 
resilience of the healthcare sector. It is a key pillar.
    Children account for 25 percent of the population and their 
unique vulnerabilities mean that preparedness and response 
activities at all levels must account for their needs. Children 
are not little adults.
    I concur with the comments of my esteemed colleagues here, 
but I would offer three additional thoughts in terms of 
recommendations.
    First, reauthorize and strengthen the HHS National Advisory 
Committee on Children and Disasters with subject matter experts 
from the public and private sector, the NACCD has provided 
insightful reports with cogent recommendations to improve 
healthcare preparedness for children.
    Two, authorize the CDC Children's Preparedness Unit, which 
has proven to be an invaluable resource to the CDC, the 
pediatrician community, schools, and other child-serving 
institutions during recent emergencies, such as Ebola and Zika. 
This unit is a best practice example of an effective public and 
private sector partnership that has brought tremendous value to 
preparedness.
    Finally, to reiterate comments that have been made already, 
let us maintain the HPP and PHEP grant programs as distinct, 
nationwide programs with strong pediatric performance measures, 
and with increased funding.
    As disasters and universal risks, such as influenza, can 
occur anywhere in the Nation, it is essential that all 
jurisdictions have a baseline level of preparedness aided by 
each of these programs.
    I want to thank the Committee for the opportunity to 
testify and I look forward to your questions.
    [The prepared statement of Dr. Krug follows:]
                  prepared statement of steven e. krug
    Chairman Alexander and Ranking Member Murray, thank you for the 
opportunity to speak here today about our Nation's preparedness and 
response capabilities. My name is Dr. Steven Krug. I am head of the 
Division of Emergency Medicine at Ann & Robert H. Lurie Children's 
Hospital of Chicago and Professor of Pediatrics at Northwestern 
University Feinberg School of Medicine in Chicago, IL. I am board 
certified in Pediatrics and Pediatric Emergency Medicine. I am here 
today in an official capacity representing the American Academy of 
Pediatrics where I serve as chair of its Disaster Preparedness Advisory 
Council. The American Academy of Pediatrics (AAP) is a non-profit 
professional membership organization of 66,000 primary care 
pediatricians and medical and surgical pediatric subspecialists 
dedicated to health and well-being of children.
    By way of additional background, I also serve as chair of the 
Assistant Secretary for Preparedness and Response (ASPR) National 
Biodefense Science Board, now referred to as the National Preparedness 
and Response Science Board (NPRSB). Additionally, I am a member of the 
Food and Drug Administration's Pediatric Advisory Committee Ethics 
Subcommittee. I am not representing either of these entities here 
today.
    I applaud the work of this committee for strengthening and 
improving our Nation's public health and medical preparedness with the 
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 
2013. In particular, AAP thanks the leadership of Members of this 
Committee for including first-ever provisions for children in the last 
reauthorization. Those changes have helped to make the needs of 
children in emergency planning and response a higher priority in our 
Federal agencies.
    As we heard last week from Drs. Bob Kadlec, Stephen Redd, and Scott 
Gottlieb, each of our key Federal health care agencies--ASPR, the 
Centers for Disease Control and Prevention (CDC), and the Food and Drug 
Administration (FDA)--has an important and distinct role to play in 
ensuring our public health and medical sectors are better prepared to 
meet the needs of all Americans, including, of course, children before, 
during, and after a disaster. The leaders of these Federal agencies, 
present and past, and the countless hard-working, dedicated Federal 
employees they oversee serve as the backbone of our Nation's 24/7 
emergency readiness and response capacity and deserve much credit for 
their work on behalf of all Americans. AAP values its close partnership 
with these Federal agencies and others and we look forward to 
continuing to work collaboratively with them.
    By most accounts, the frequency, severity, and cost of disasters 
and emergencies are increasing, meaning they will remain a significant 
threat to the health and safety of communities and our Nation. As such, 
maintaining and expanding the Federal Government's strategic focus on 
multi-and all-hazard approaches that address both routine and health 
security related needs is critical. This means continuing to engage all 
stakeholders, including public health, medical, mental and behavioral 
health services, academia, industry, and day-to-day emergency medical 
and trauma services in strengthening ``foundational'' programs core to 
preparedness. \1\ Emergency Medical Services (EMS), trauma and burn 
centers, and our Nation's children's hospitals must be strong and 
engaged.
---------------------------------------------------------------------------
    \1\  National Preparedness and Response Science Board. ASPR Future 
Strategies Report. March 30, 2015. http://www.phe.gov/Preparedness/
legal/boards/nprsb/recommendations/Documents/aspr-fswg-
report03162015.pdf
---------------------------------------------------------------------------
    Healthcare systems that are regularly tested may be the most 
effective and reliable in a response. In a sense, the concepts of 
preparedness and response are actually interchangeable. The Centers for 
Medicare and Medicaid Services (CMS) Emergency Preparedness Rule which 
sets national emergency preparedness requirements for Medicare and 
Medicaid-participating providers and suppliers is critically important 
for ensuring adequate planning for both natural and man-made disasters, 
and coordination with Federal, state, tribal, regional, and local 
emergency preparedness systems. However, investments in preparedness, 
maintenance of a stable workforce, and sustainment of core response 
capabilities can be challenging. Major reductions in Federal spending 
on public health and medical preparedness as well as intermittent 
surges around specific disasters or spikes in seasonal influenza like 
we are currently experiencing combine to adversely impact the 
preparedness of the Nation.
    Physician and health care professional workforce burnout and 
inability to practice self-care in the face of a disaster, one in which 
health care providers and their families may have personally 
experienced injury or loss, must be addressed as part of medical 
preparedness and response.
    At a population level, we should strive for healthier communities 
pre-disaster which will reduce the burden on the health care system 
during and after a disaster. This means ensuring access to affordable 
medical and mental or behavioral health care and preventive services 
and reducing or eliminating health care disparities in all populations.
              Ensuring the Health of Children in Disasters
    Children account for twenty-five percent of the population and 
their unique vulnerabilities mean that preparedness and response 
activities should account for their distinct needs. Children are not 
little adults and the factors a state, city, hospital, or community 
must consider when planning for children may differ when considering 
the care needs of infants versus preschool-aged children versus 
adolescents. Additionally, children spend much of their day separated 
from their parents at school or in child care, making issues of 
preparedness planning in these settings, including training exercises 
and drills, mechanisms for child tracking and timely family 
reunification, and, consent for treatment, if needed, particularly 
important.
    At the Federal level, AAP remains concerned about the 
appropriateness of the current statutory definition of and references 
to ``at-risk individuals'' throughout PAHPA. According to ASPR, at-risk 
individuals are children, older adults, pregnant women, and individuals 
who may need additional response assistance. This includes but is not 
limited to individuals with disabilities, individuals who live in 
institutional settings, individuals from diverse cultures, individuals 
who have limited English proficiency or are non-English speaking, 
individuals who are transportation disadvantaged, individuals 
experiencing homelessness, individuals who have chronic medical 
disorders, and individuals who have pharmacological dependency. By some 
estimates, this could amount to fifty percent of the total population.
    The expertise needed to successfully plan for and respond to a 
public health emergency involving a person with a pharmacological 
dependency is very different from that of a child or of a pregnant 
woman. Given the discretion allowed under current requirements for 
states and cities in the CDC's Public Health Emergency Preparedness 
Program (PHEP), a jurisdiction can ``check the box'' by including one 
of these categories in disaster drills and exercises. In fact, in a 
PHEP Impact Assessment conducted in 2014, of the select PHEP 
capabilities reported on, the two poorest performing measures were 
those that directly related to children: Did the grantee have a 
sufficient plan for vulnerable populations (55 percent) and did the 
grantee have patient tracking capability for family reunification (47 
percent). By contrast, all other measures were met 73 to 100 percent of 
the time.
    AAP would urge Federal agencies including ASPR to move away from 
generic terms like ``at risk'' or ``vulnerable'' populations. When 
agencies or grantees are forced to address this broad category, the 
subpopulations contained within may be overlooked. We would suggest 
that ASPR consider creating a position of Director of Pediatric 
Preparedness and Response who is empowered and adequately resourced to 
work within ASPR, with its grantees, and with HHS partner agencies to 
improve our Nation's preparedness and response for children.
   Healthcare System Preparedness, Response, Recovery, and Resilience
    At baseline, our health care delivery system is fragile, 
decentralized, frequently uncoordinated, and regional. Financial 
drivers in the health care system are not aligned with the need for 
facilities to be prepared for emergencies and surges in the number and 
acuity of patients seeking care. Cost-reduction efforts within health 
care systems have led to skilled staffing shortages and leaner 
stockpiles of routine supplies, medications, and key equipment. This 
environment has caused hospital inpatient facilities to operate much 
closer to full capacity and emergency department overcrowding, driven 
largely by inadequate inpatient capacity, leads to poor surge capacity. 
So, when disasters occur, it's not hard to see why many communities 
struggle to respond and why some may never recover.
    Changes to the economic environment are creating serious challenges 
for scientific research and innovation and are reducing public health 
system stability. In addition, the health care sector is in a State of 
rapid change, with adaptations underway to health care delivery models, 
health care systems, and health care financing. In this State of rapid 
change and uncertainty, with decreasing funds and increasing fiscal 
pressures, economic or service delivery disengagement by public and 
private sector safety net providers and other partners critical to 
health security (e.g., health departments, hospitals, academic medical 
centers, biotechnology and pharmaceutical industries) is reported from 
the field. In addition to the effect of economic change on individual 
sectors, these same stressors have the potential to further harm 
relationships among the various components of the larger system 
including Federal-state-local-private sector interactions. These 
relationships are critical to an effective response. \2\
---------------------------------------------------------------------------
    \2\  Ibid.
---------------------------------------------------------------------------
    With respect to children, the majority of ill and injured children 
seek care at the closest emergency department in their community. 
Eighty-nine percent of children in the emergency care system are seen 
in non-children's hospitals. \3\ It is critical that all EDs have the 
appropriate resources and staff to provide effective emergency care for 
children but many see few pediatric patients per day--roughly 50 
percent of U.S. emergency departments provide care for fewer than ten 
children per day. On a nationwide level, AAP, along with the American 
College of Emergency Physicians, the Emergency Nurses Association, and 
other professional societies, issued guidelines on the care of children 
in the emergency department to aid all emergency departments in what to 
prioritize for children.
---------------------------------------------------------------------------
    \3\  Emergency Medical Services for Children National Resource 
Center. National Pediatric Readiness Project. Available: http://
pediatricreadiness.org/About--PRP/
---------------------------------------------------------------------------
    AAP thanks Senators Orrin Hatch and Bob Casey for their strong 
leadership on the Federal Emergency Medical Services for Children, or 
EMSC, Program, the only Federal program that focuses specifically on 
improving the pediatric components of the Emergency Medical Services 
(EMS) system. Under the leadership of the EMSC Program at the Health 
Resources and Services Administration, in partnership with several 
professional societies, we now have the National Pediatric Readiness 
Project, a multi-phase quality improvement initiative to ensure that 
all U.S. emergency departments have the essential guidelines and 
resources in place to provide effective emergency care to children.
    Of the 4,146 emergency departments that participated in the 2013 
National Pediatric Readiness assessment, the overall hospital Pediatric 
Readiness score was 69 percent but only 47 percent of participants 
responded that they have a disaster preparedness plan in place that 
addressed the unique needs of children. \4\ The project found that the 
presence of a Physician and Nurse Pediatric Emergency Care Coordinator 
(PECC) was associated with a higher Pediatric Readiness score compared 
with no PECC. The potential for improving patient outcomes based on the 
findings of the National Pediatric Readiness Project is great. These 
findings also have important implications for the Hospital Preparedness 
Program (HPP) and ASPR's broader healthcare system preparedness 
efforts.
---------------------------------------------------------------------------
    \4\  Gausche-Hill, M., Ely, M., Schmuhl, P. A National Assessment 
of Pediatric Readiness of Emergency Departments. JAMA Pediatr 
.2015;169(6 :)527-534 .doi:10.1001/jamapediatrics.2015.138
---------------------------------------------------------------------------
    In order for the medical care system to respond, recover, and 
ultimately be resilient, preparedness planning must include not just 
public health and hospitals but also the primary care medical delivery 
system. While that system is largely in the private sector, it cannot 
be ignored. Primary care providers, such as pediatricians, are on the 
front lines of all emergencies. The administration of vaccines, 
provision of anticipatory guidance and appropriate screenings, and the 
counseling of patients and families are some of the vital functions of 
primary care, the continuity of which are all highly relevant to public 
health emergencies.
    While the opportunity exists to improve further upon present 
disaster planning and response capabilities, we must also focus on 
recovery and the components of resiliency. Community resilience relies 
heavily upon the resilience the healthcare sector, a key pillar. As 
such, the Federal Government should support the ability of patients to 
return to their regular source of local medical care. After a disaster, 
medical offices and equipment are often damaged, and loss of power can 
lead to spoilage of vaccine doses. Lack of usable or safe office space 
and staff, housing, water, power, and telephone service have repeatedly 
hindered physician efforts in reestablishing practices. Further, local 
physicians may find themselves competing for patients with free or 
temporary clinics set up in the aftermath of the disaster. In the face 
of these circumstances, many physicians are forced to close their 
practices and leave the community. The Federal Government should 
develop formal incentives and assistance programs to provide 
systematic, long-term, financial stability to private physician 
practices after disaster strikes. \5\, \6\ Collaboration between ASPR 
and the Centers for Medicare and Medicaid Services (CMS) is critical. 
As the Federal agency responsible for payment for medical services and 
for ensuring families affected by disasters seamlessly continue their 
insurance coverage under Medicaid and CHIP or become newly eligible for 
Medicaid or CHIP because of a disaster, CMS and ASPR must work closely 
together.
---------------------------------------------------------------------------
    \5\  National Preparedness and Response Board. Assistant Secretary 
for Preparedness and Response (ASPR) Future Strategies Report.
    \6\  National Biodefense Science Board. Community Health Resilience 
Report.
---------------------------------------------------------------------------
    After an emergency, physicians are often eager to provide medical 
assistance to affected communities. While the National Disaster Medical 
System (NDMS) has an important role to play in our Nation's emergency 
medical response, it lacks the size and quantity of needed specialists 
to reach all communities that are or could be affected by disasters. 
AAP encourages ASPR to consider a more efficient infrastructure so 
that, in event of an emergency, physicians eager to provide volunteer 
medical services have a way to do so quickly.
                  Medical Countermeasures for Children
    Significant strides have been made over the past ten to 15 years to 
develop medical countermeasures (MCMs) to address potential disaster 
hazards, including chemical, biological, radiologic, and nuclear 
threats. \7\ Yet, major gaps still remain related to MCMs for children, 
a population highly vulnerable to the effects of exposure to such 
threats, because of their physiology and developmental differences from 
adults. Many vaccines and pharmaceuticals approved for use by adults as 
MCMs do not yet have pediatric formulations, dosing information, or 
safety information. As a result, the Nation's stockpiles and caches 
where pharmacotherapeutic and other MCMs are stored are less prepared 
to address the needs of children compared with those of adults in the 
event of a disaster.
---------------------------------------------------------------------------
    \7\  American Academy of Pediatrics DISASTER PREPAREDNESS ADVISORY 
COUNCIL. Medical Countermeasures for Children in Public Health 
Emergencies, Disasters, or Terrorism. Pediatrics, originally published 
online January 4, 2016; DOI: 10.1542/peds.2015-4273
---------------------------------------------------------------------------
    Congress made important changes in the last PAHPA reauthorization 
to Emergency Use Authorizations (EUAs) that allow an EUA to be issued 
for preparedness purposes.
    The Strategic National Stockpile (SNS) is currently underfunded to 
support the necessary stockpiling and replacement of MCMs as well as to 
support research, development, and procurement of pediatric MCMs. We 
must ensure that the SNS is adequately funded to meet these needs and 
that safety and dosing for children are considered. \8\
---------------------------------------------------------------------------
    \8\  Ibid.
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 Recommendations for the Next Reauthorization of the Pandemic and All-
                        Hazards Preparedness Act
      Reauthorize and Strengthen the HHS National Advisory 
Committee on Children and Disasters--AAP notes the important 
contributions of the HHS National Advisory Committee on Children and 
Disasters (NACCD) since this committee created it under PAHPRA in 2013. 
The NACCD contains numerous subject matter experts from the public and 
private sector. It has provided HHS with several thoughtful reports 
with recommendations for healthcare preparedness for children, surge 
capacity, strategies for human services and child-serving institutions, 
and a joint report with the NPRSB on youth leadership and resilience. 
AAP strongly supports the reauthorization of the NACCD and asks 
Congress to align the NACCD with the NPRSB by making it permanent and 
resourced. AAP has recommendations for additional areas of expertise 
that would be helpful to add to the NACCD such as mental or behavioral 
health, children and youth with special health care needs, schools and 
child care, trauma and critical care, among others. It is our hope that 
the ASPR will utilize the expertise of the NACCD and the NPRSB to 
enhance its preparedness and response efforts.
      Authorize the CDC Children's Preparedness Unit--AAP asks 
Congress to authorize the Children's Preparedness Unit (CPU) at CDC. 
The CPU has proven to be an invaluable resource to the CDC, the 
pediatrician community, schools, and other child-serving institutions 
during recent emergencies such as Ebola and Zika. The CPU is an 
internal team of experts within CDC with a background in pediatrics, 
behavioral science, child psychology, epidemiology, biostatistics, 
health communications, and more that is providing leadership and 
technical assistance, training, and consultation with the CDC and to 
Federal, state, and local public health entities to improve 
preparedness and response for children including under the PHEP 
Program. Members of the CPU have been activated or utilized as part of 
a CDC emergency response and, as Dr. Redd noted to this committee, they 
leverage public-private partnerships to address gaps in emergency 
preparedness and response for children.
      Funding for Public Health and Medical System Preparedness 
and Response--HPP and PHEP are key to the foundational capabilities of 
healthcare and public health preparedness, respectively. These 
critically important Federal programs must be resourced at sufficient 
levels to ensure every community is prepared for disasters. HPP's 
highest level of appropriation was $515 million, yet the program has 
eroded to only $255 million, a vastly insufficient level given the task 
of preparing the healthcare system for a surge of patients, continuity 
of operations, and recovery. As Dr. Kadlec noted before the committee 
last week, we have a roughly $3.3 trillion health care system, so a 
Federal investment of only about $250 million is not realistic if we 
are to have a truly prepared and resilient health care system. AAP 
urges Congress to authorize HPP at a minimum of $474 million, the level 
authorized in the PAHPA legislation of 2006. PHEP, currently funded at 
$660 million, should be authorized at a minimum of $824 million, the 
level authorized in the 2006 PAHPA bill. Federal funding is crucial to 
maintaining state, local, and territorial public health preparedness 
capacity. Even small fluctuations in funding--such as the 2016 transfer 
of $44 million from PHEP for the Federal Zika response--have major 
impacts on workforce, training and readiness. \9\

    \9\  https://www.naccho.org/uploads/downloadable-resources/Impact-
of-the-Redirection-of-PHEP-Funding-to-Support-Zika-Response.pdf
---------------------------------------------------------------------------
    We cannot let happen again what transpired during the Zika response 
where Federal agencies' ability to respond was hampered by delays in 
congressional action on emergency funding. A pre-approved standing fund 
for short-term scale-up of rapid, emergency response is necessary. Such 
a fund should be administered by the HHS Secretary and should 
supplement and not supplant existing, base public health and 
preparedness funds. Funding should not come at the expense of other 
health programs, either from discretionary health spending or by 
transfer. Such a fund should serve as an interim bridge between 
underlying capacity-building funds and emergency supplemental funds, if 
needed. While such a fund should have sufficient resources, it cannot 
be viewed as a substitute for future supplemental emergency funding.

      Public Health and Medical System Preparedness are 
Distinct and They Should Be nationwide with Strong Pediatric 
Considerations--Because disasters can happen anywhere in the country 
and universal risks such as influenza pandemics and mass shootings 
exist, it is essential that all jurisdictions have a baseline level of 
preparedness aided by the HPP and PHEP programs. Performance measures 
for both programs must include meaningful metrics that assess a 
jurisdiction's preparedness to identify and meet the needs of children. 
Given the important role pediatricians play in the response and long-
term recovery and resilience of communities, pediatricians should be 
integrated into all health care coalitions to help serve as pediatric 
subject matter experts and to help integrate pediatric components into 
planning, including drills and exercises. While HPP and PHEP should 
continue to be aligned and coordinated, they must remain as separate, 
distinct programs. The two programs serve a different but complementary 
purpose: PHEP builds the capacity of state, local, and territorial 
health departments and laboratories to prevent, detect, and respond to 
emergencies, while HPP prepares the healthcare delivery system to 
provide essential care to patients by ensuring continuity of care 
during disasters. Both programs are needed to save lives and protect 
the public from emergency-related illnesses and injuries.
      Children with Special Healthcare Needs--The HHS emPOWER 
map allows every hospital, first responder, electric company, and 
community member to use the map to find the monthly total of Medicare 
beneficiaries with electricity-dependent equipment claims at the U.S. 
State, territory, county, and zip code level and turn on ``real-time'' 
natural hazard and NOAA severe weather tracking services to identify 
areas and populations that may be impacted and are at risk for 
prolonged power outages. This technology has the potential to save the 
lives of over 2.5 million Medicare beneficiaries who rely upon 
electricity-dependent medical and assistive equipment, such as 
ventilators and wheel chairs, and cardiac devices in our communities. 
However, emPOWER is currently limited to Medicare beneficiaries. AAP 
urges ASPR and HHS to conduct feasibility testing for piloting how 
emPOWER could be expanded to the Medicaid program so that millions of 
children and youth, including those with special health care needs can 
benefit from this technology.
                                 ______
                                 
    Senator Burr. Dr. Krug, thank you.
    As evidenced by the fact that I am not sure that we have 
had, in the past, a pediatrician before in PAHPA related 
hearings, it shows that we understand the need to get it right.
    I might say it is probably one of the most challenging 
areas because it is hard to incorporate pediatrics in the 
cutting edge technologies that, on one side, we are pushing 
that that will always be a challenge to us and we need more 
subject matter experts to help us navigate through that.
    I will recognize Members for up to 5 minutes starting with 
myself and move on a seniority basis.
    Mr. MacGregor, Seqirus has worked for many years to make us 
better prepared in the event of an outbreak of pandemic flu. 
The facilities in Holly Springs, North Carolina are both a 
promise and a partnership between your company and the Federal 
Government that, if needed, we can flip a switch from the 
manufacturing of vaccines for seasonal flu to the manufacturing 
for pandemic flu.
    What are the lessons learned from this partnership? And, 
how can we improve the partnership?
    Mr. MacGregor. Thank you for the question.
    I think the lessons we have learned thus far that the 
partnership has been a very good one since the very beginning. 
What has happened, really, in recent years is the commitment 
that has been made, and for which Seqirus and its predecessor 
companies have delivered, the funding has not kept up with what 
we believe is the threat going forward.
    So whereas there was a period of time, and even though the 
funding for a pandemic flu, BioShield was not part of the 
original PAHPA legislation, there was emergency funds, 
supplemental funds that were provided for flu.
    I think the big lesson we have learned since that time is 
as the funding has declined to very low levels, particularly 
since 2009, you start to question the commitment. And while we 
put a commitment forward, a partnership forward with BARDA, I 
think sometimes we feel that with the funding that is dedicated 
or earmarked for pandemic flu suggests that there is not a 
seriousness or as serious an interest taken to this particular 
threat going forward. I think that is one of the lessons we 
have learned.
    I think communication, ongoing communication is another 
lesson we have taken. I think, for the most part, the 
communication between BARDA and our company, and BARDA and 
other companies that are in partnership with the Government, 
has been good, but there is always opportunity for improvement 
across the spectrum from NIAID all the way to the SNS.
    It is not bad. There is still room for improvement there in 
harmonizing how it works across that entire spectrum.
    Senator Burr. The jurisdictional lines were a little 
difficult at the beginning.
    Mr. MacGregor. Yes.
    Senator Burr. But I think we have gone through a lot of 
that.
    I hope that my colleagues on this Committee will remember 
this year's flu season, the severity of it. We do not know yet, 
but as we get smarter at projecting what the threat is going to 
be, this is a great example that we are not smart enough to get 
it better than 32 percent right based upon the current numbers. 
And that we have got to look at technology that allows us to 
address seasonal flu in a way that encompasses all of the above 
options that might happen.
    You mentioned BARDA. BARDA works to advance new and 
innovative technologies to better combat public health threats 
and has been extremely successful in advancing innovative 
approaches to the development of medical countermeasures such 
as platform technology.
    What do you see as the greatest challenges to bringing 
these new, and innovative, technologies through the medical 
countermeasure pipeline?
    Mr. MacGregor. Well, I think one example of what you 
mentioned, Senator Burr, is new and innovative platform 
technologies and the plant in Holly Springs is an example of 
this. This is cell-based technology in Holly Springs. It is not 
the more conventional egg-based which, I think, most people are 
aware.
    The interaction with BARDA has been very strong in not only 
allowing us to continue to advance the effectiveness of cell-
based technology--most recently through the partnership through 
efforts to improve the yields of cell-based technology that 
cannot only benefit in a pandemic setting--but actually will 
potentially benefit in a seasonal setting as well.
    The benefit that ideally will come will not only be, 
hopefully, in vaccines coming sooner to market, but the other 
promise we hope with cell-based technology as an example of a 
platform--technology that is invested in by the Government--is 
that it offers the potential of providing a better match in the 
event of a mismatch season, as we are experiencing this year.
    Senator Burr. Tom, let me turn to you, if I can.
    Innovations and information technology have drastically 
improved our biosurveillance and situational awareness 
capabilities to monitor, detect, and identify public health 
threats in as timely a fashion as is possible. Though this 
potential exists, the Federal Government lags behind in its 
ability to leverage these technologies.
    How can we improve the Federal programs to create a more 
cohesive and real time surveillance capability for public 
health threats? And just as an aside to that, do you believe 
that we use enough open source information outside of the 
mechanisms we have set up domestically and internationally?
    Dr. Inglesby. Sir, that is a very good question. People 
have been working on that for a long time.
    There are many surveillance systems in the country right 
now that are aimed at that goal. They are not all brought 
together under one roof, which would be very difficult to do. I 
know it has been a goal of the Federal Government to try and 
consolidate and bring those systems together.
    One of the things that we could do better is to get more 
information out of the healthcare system, to public health, 
during emergencies. We have a lot of advances in Electronic 
Health Records, but for the most part, public health agencies 
do not have any resources or analytics to be able to see what 
is going on in healthcare records around the country.
    If we could do more to bridge that divide between public 
health and medicine, that is where a lot of the information, 
that is where the signals are going to come in during outbreaks 
from doctors and nurses seeing unusual things and feeding that 
information to public health, getting laboratory diagnostics, 
getting that information together.
    I think closing that divide a little bit and also bringing 
together unusual sources of information like what is going on 
in the animal systems, combine that with human systems. Being 
able to trace back foods when big food outbreaks arise; that is 
a very difficult challenge for us right now.
    Senator Burr. We are much better at a lot of it than we 
were a number of years ago.
    Dr. Inglesby. Much better, but a lot of challenges.
    Senator Burr. John is on the frontline and I feel confident 
that mechanisms are in place for that transmission of 
information. All we need is one breakdown.
    It does make one wonder, in the overall scheme of things, 
why we are not layering on top of that a review of scripts 
written on a daily basis that gives us either confirmation of 
what we are hearing from the public health arena, or 
potentially a sign of an outbreak of something that we pick up 
in prescriptions that were administered the day before.
    The unusual thing is that gives us great clarity as far as 
the geographical location of something all the way down the 
nine digit ZIP Code.
    It seems like it is all of the above that we have to do.
    Senator Casey.
    Senator Casey. Thank you, Senator Burr.
    Dr. Inglesby and Dr. Dreyzehner, I will start with you.
    Senator Burr talked about the flu this year. We are told 
that more than 17,700 cases of the flu have been confirmed just 
in Pennsylvania. Thirty-two people, including one child, have 
passed away because of that.
    While this is a particularly bad flu season, it does not 
come close to what we would see on a much larger scale in an 
infectious disease emergency or, of course, a pandemic flu 
scenario. Our healthcare sector is already near capacity with 
this flu season. So we are woefully unprepared to respond to a 
mass casualty, biological event.
    For both Dr. Inglesby and Dr. Dreyzehner, I would ask, how 
can we begin to prepare hospitals--let us just focus on 
hospitals--for a mass casualty, biological event?
    I know that is a lot to bite off, but as best you can.
    Dr. Dreyzehner. Thank you for the question, Senator. I 
certainly welcome Dr. Inglesby's comments as well.
    I think as has been said, fully funding PHEP and HPP to its 
prior levels would be hugely helpful. I think Dr. Krug made 
some really important points in terms of the financial 
incentives of the current system's just-in-time for supplies 
and for staffing. There is limited surge capacity and we are 
seeing that in Tennessee right now.
    In fact, I had a call with our hospitals a couple of weeks 
ago. I have another call tomorrow. Some of the challenges that 
are----
    This is a flu season that, I think, is more severe than we 
typically see. As, I think, Senator Burr pointed out, we do not 
know exactly what this will look like in comparison to other 
flu seasons.
    I think one thing is true, we are reporting more. Many 
states are reporting all deaths. Our state is reporting child 
and pregnancy deaths. As Senator Alexander pointed out, we have 
already had several tragic preventable deaths.
    As people hear about those things, there is a perception of 
greater severity. And when there is a perception of greater 
severity, people frequently visit places like emergency rooms.
    One of the things we have been doing is messaging around, 
``If you are ill, you may need to call your healthcare 
provider, but you may not need to go to an emergency room.'' So 
all those kinds of things are a part of what we deal with in a 
flu season where there is a heightened awareness.
    In terms of assuring that we are prepared, the amount of 
funding available to the HPP grant has been inadequate, really, 
for some time. And, I think as you pointed out in your 
comments, there is a need to bolster that.
    I do not think it takes a great deal more, but certainly 
returning to earlier funding levels would be extremely helpful.
    Senator Casey. Dr. Inglesby.
    Dr. Inglesby. Yes, I would agree with everything he said.
    I would add that, going back to the beginning of the 
hearing, the more that we can develop our flu vaccine 
technologies, universal flu vaccine being the ultimate goal, 
but modernization and rapid acceleration of the process being 
the interim goal, the less we will have sick people in 
hospitals. But in the meantime, we need a strong healthcare 
system preparedness program through HPP.
    There could be other facets of that program, like having 
more regional centers, that could shoulder more responsibility 
in crises, take care of more contagious patients. We have a 
Level One trauma center system in the United States that works 
very well, but we do not have anything like that for infectious 
disease. That could be a model.
    We have built biocontainment units in places around the 
country in response to Ebola, but most of those containment 
units can only take care of one, or two, or three patients at 
most. So if we want to try and raise the level of preparedness, 
we might think about creating some regional strength.
    But at most hospitals, they are going to need to be able to 
take care of patients. They are going to need proficiency, 
personal protective equipment, and relationships with the other 
hospitals, and the public health agencies, and the surgery 
clinics, and the medi-clinics where people are getting cared 
for in the community.
    It is a network of care as opposed to only relying on the 
major, acute care hospitals and have to distribute that burden 
out to the community when there are major epidemics of flu or 
even pandemics of flu.
    Senator Casey. You mentioned, and I know I am going to be 
out of time in a moment, but I might come back to it after we 
have other questions.
    But the Level One trauma center model, that is my word not 
yours, how do you think we incentivize that in the context of 
what, I think, in your testimony on Page 3, you refer to as, 
``specialized Disaster Resource Hospitals,'' another acronym, 
DRH?
    I might ask you that question. I am out of time, but then I 
will come back later to Dr. Krug to add his comments on it.
    Dr. Inglesby. I think the way you would incentivize it is 
you could have some kind of competition for it, but you would 
have to provide resources for it because there is no, as we 
have said already here today, there is no ``give'' in the 
system. Hospitals are running very small margins, so they are 
not going to be able to build large entities or programs 
outside of the usual programs unless the Government says, ``We 
want you to do this, and here is how.''
    Senator Casey. Thanks very much.
    Senator Burr. Senator Isakson.
    Senator Isakson. Thank you, Chairman Burr.
    Dr. Inglesby, you wrote of the national security agenda, 
the Global Health Security Agenda in your comments that was 
established in 2014.
    Where is it housed today?
    Dr. Inglesby. It is in multiple agencies of Government, 
particularly the CDC and USAID.
    Senator Isakson. Who is the quarterback for it?
    Dr. Inglesby. The quarterback for it, I think you would 
say, is the USAID and CDC directors.
    Senator Isakson. Who are integrally involved.
    Dr. Inglesby. Yes.
    Senator Isakson. In fact, when the Ebola outbreak took 
place, and you referred to some places around the United States 
that had containment areas already built and things like that.
    Dr. Inglesby. Yes.
    Senator Isakson. From a modest standpoint, we were able to 
meet the threat at Emory University at NIH and a couple of 
other places with those first Samaritans, those first doctors 
who came back from, I think, Liberia which is where it broke 
out.
    Dr. Inglesby. Right.
    Senator Isakson. That was enough at the time. But how much 
of that do you think should be built in preparation or to 
anticipate needing to have something like that happen again, 
maybe not for Ebola, but for some other infectious disease?
    Dr. Inglesby. Well, I think Emory was a national leader in 
that program, and I think if you were to speak to the leaders 
in that program, they would say that it would be difficult for 
them to take care of more than one or two patients in the 
current units.
    I think we need to get better cost information about how 
much those units cost. It would be difficult to scale those by 
orders of magnitude by 10 or 100, but I think we could build 
more capacity in the systems, share the lessons that have been 
learned in those units, see if we can spread that 
responsibility out a bit further, because right now, it is a 
pretty small number of units that can care for any patients 
with that.
    Senator Isakson. As in most cases, capital and money is the 
secret.
    Dr. Inglesby. And training, yes, exactly. Capital, money, 
training, and specialized people.
    Senator Isakson. You talked in your testimony about a 
contingency fund or you recommended having some sort of a 
contingency planning funding for that.
    Do you have any recommendations of where that ought to be 
and how much it ought to be?
    Dr. Inglesby. The contingency fund?
    Senator Isakson. Yes.
    Dr. Inglesby. If you base contingency funding on what we 
have spent in other infectious disease emergencies, we 
typically have spent at least $500 million to $1 billion as a 
country in response to things like H9N1, Ebola, Zika, sometimes 
much more. And so, a fund that was somewhere in that range.
    I think public health agencies, and others outside of our 
center, have called for a $2 billion contingency fund. That is 
closer to what FEMA uses for its disaster relief funding. I 
think that would provide a lot of acceleration in the public 
health response and emergencies.
    Senator Isakson. And because biological threats and disease 
threats do not recognize national boundaries or oceans as 
barriers, it is something the whole world community has really 
got to participate in together. Right?
    Dr. Inglesby. Yes, absolutely.
    Senator Isakson. And CDC is great at coordinating things 
like that and so is USAID, and they did a great job on the 
Ebola.
    But that would be where the international agenda ought to 
coalesce a game plan and a contingency fund?
    Dr. Inglesby. Yes. I think the way the Global Health 
Security Agenda has worked, and one of its successes, is that 
it brings in different parts of government, including the 
finance sides of government and the security sides of 
government.
    In the U.S., it is bigger than the CDC and USAID. There is 
participation by security, and by finance and economics, and 
that is the model they are trying to get other countries to 
represent as well.
    Senator Isakson. Mr. MacGregor.
    Mr. MacGregor. Yes.
    Senator Isakson. Does the plant in North Carolina 
manufacture the flu vaccine?
    Mr. MacGregor. Yes.
    Senator Isakson. How are we doing on that? Do we still have 
enough, given the current epidemic that is going on?
    Mr. MacGregor. Yes. We have been constantly enhancing the 
capability in that plant. So from a seasonal perspective, just 
looking at it from a seasonal perspective, we more than tripled 
our capacity into the market this year on a seasonal 
perspective.
    That plant is also responsible, as I mentioned, in 
delivering one-third of the requirement in the event of a 
pandemic and responding within a 6-month period.
    Senator Isakson. And you are cell-based?
    Mr. MacGregor. It is cell-based. That is correct.
    Senator Isakson. What is the shelf life of that vaccine?
    Mr. MacGregor. Well, the shelf life of the vaccine from a 
pandemic perspective, the antigen is 5 years. Unfortunately, we 
do have antigen that is in the stockpile right now that is 
older than that from an egg and from a cell perspective. But 
that is the state of affairs right now as far as our cell-based 
vaccine is concerned. We also have to promise----
    By the way, Senator, as I said, it offers the potential of 
being a better match in the event of a mismatched strain, so as 
an alternative form of manufacturing and the reason for the 
initial public-private partnership. That is some of the promise 
that our company is trying to deliver on, on behalf of the 
government.
    Senator Isakson. Thank you very much.
    Thanks to all of you for your testimony.
    Senator Burr. Thank you.
    Senator Hassan.
    Senator Hassan. Thank you, Senator Burr.
    Senator Casey, thank you for your leadership on this issue.
    To our panelists, good morning, and thank you for being 
here.
    Dr. Inglesby, I wanted to start with a question for you.
    As we all know, Puerto Rico was recently devastated by 
Hurricane Maria and the island is still trying to rebuild from 
the disaster. The effects of that disaster are obviously 
widespread.
    Hospitals in New Hampshire, and around the country, are 
dealing with, among other effects, medical product and 
equipment shortages such as I.v. saline bags because the storm 
devastated some of the manufacturers on the island.
    So Doctor, what does this shortage say about our overall 
preparedness in the case of a future event or other types of 
emergencies where medical supplies cannot be easily 
replenished? What can we do here in Congress with this issue 
when we reauthorize PAHPA?
    Dr. Inglesby. Senator Hassan, yes, I agree with you 
completely that the Puerto Rico hurricanes and other storms 
have revealed how vulnerable our supply systems are.
    One possibility to consider would be whether there are some 
critical supplies, such as saline bags, if they are single 
sourced to a part of the world, or some active products, or 
pharmaceuticals, if they are single sourced, whether or not 
they should be included in the national pharmaceutical 
stockpile.
    That is not how the stockpile is configured or resourced 
now, so there would need to be additional resources for an 
additional mission.
    But the stockpile has a great success in acquiring 
medicines and being able to deliver them to localities. So that 
would be one possibility if there were an additional purpose 
and funding for the stockpile.
    Senator Burr. Senator, can I interject?
    Senator Hassan. Sure, yes.
    Senator Burr. The time will not count against you.
    Holly Springs is a great example, and the other two 
facilities, that when faced with a pandemic, we actually became 
visionary.
    Senator Hassan. Yes.
    Senator Burr. And we thought, ``What can we do to meet what 
we do not know?''
    We went into a partnership with three different companies 
where we funded three-quarters of the facility of the plant, 
but with a condition written into it that at any point, we 
could turn it into what is in the Nation's best interest. And 
all three owners knew that and participated in it.
    So it may be a model that we look at as we identify other 
things, but we have shown a degree of vision in the past.
    Senator Hassan. I think that is very helpful and I think 
the example of what happened on Puerto Rico after Maria really 
helps us focus on one of the next things we should be doing.
    I also wanted to ask all of you, and I think I would start 
the question with you, Dr. Dreyzehner. I loved what you said 
about preparedness and response being about people and time, 
and obviously both demand resources.
    New Hampshire uses its hospital preparedness funding to 
support a single statewide healthcare coalition that works to 
bring together public health and emergency management 
professionals to assure that the healthcare system preparedness 
is there across the spectrum of care from hospitals, to 
homecare, to long term care and beyond.
    New Hampshire, like other states, relies on this funding to 
help make sure it is prepared for all kinds of emergencies, 
mass casualty incidents to hurricanes. Unfortunately, like many 
other states, New Hampshire has seen a significant decrease in 
hospital preparedness funding in recent years.
    We do not know when the next emergency will happen or what 
precisely it is going to entail, so we need to make sure that 
the coalition in New Hampshire is not only collaborating 
regularly, but training regularly. It is hard to do that, 
though, when funding is dramatically reduced.
    So I will start with you, Dr. Dreyzehner, but from all of 
you, do you agree that we need to increase investments in the 
hospital preparedness program and that it should continue to 
fund those efforts in all states?
    Dr. Dreyzehner.
    Dr. Dreyzehner. So thank you for the question, Senator. I 
would say absolutely yes, if you think about who responds.
    In my written testimony, I talk about three tiers.
    Senator Hassan. Yes.
    Dr. Dreyzehner. Professionals, people who do this every 
day. We have people that are highly trained and they are called 
upon if there is an actual emergency, like one you described, 
but they typically have different duties on a day to day basis.
    For example, one of our emergency coordinators in Tennessee 
actually directs our Board of Emergency Medical Services.
    Senator Hassan. Right.
    Dr. Dreyzehner. But when we have an emergency, she is in 
the State Operation Center.
    Then we have this third tier, which is kind of everybody 
else and the people that you are talking about. They are the 
public health nurses. They are the clinicians in the hospital. 
They are hospital nurses. They are people who are called upon 
whenever there is a need to surge.
    Their training in training, and exercising, and actually 
responding, creating the relationships, the knowhow, ``What do 
I do?'' ``Where do I go?'' ``Who do I talk to?'' Those are the 
critical things. Those are the relationships built on trust 
that the HPP funding really helps solidify.
    Unfortunately, when you reduce that funding, that is one of 
the first things that goes. Right? You try to preserve the 
positions. You try to preserve some of the things you have 
invested in, but the more fungible assets are the very things 
you need more of. And I think you spoke to those very 
eloquently.
    Senator Hassan. Well, thank you. Just in the interest of 
time, I will ask the other three panelists any thing you would 
disagree with or add to what Dr. Dreyzehner just said about the 
funding?
    Dr. Krug. Just a point. It is about people.
    The earlier question about how do we get the hospitals 
better prepared. They have to train and if you do not have 
trained people, your response will not be effective. That has 
been shown in many other industries, including healthcare.
    With the focus evolving from hospitals to healthcare 
coalitions, which is actually, I think, an appropriate move, it 
is not just the hospitals that need to be trained. It is the 
entire community that needs to be trained.
    As an emergency physician, can I just do a brief pivot?
    Senator Hassan. Yes.
    Dr. Krug. After oxygen, the elixir of life in how we care 
for patients is saline.
    Senator Hassan. Yes.
    Dr. Krug. So whether you have sepsis, because of a high-
consequence infectious disease, or you have been in an 
explosion, or a bus crash, if you do not have saline, you lose 
lives.
    So there could be nothing more fundamental to our emergency 
response, after oxygen, than saline.
    Senator Hassan. Well, I thank you.
    Senator, I know I am over. I will just submit for Dr. Krug, 
a question about behavioral health needs, especially for 
children in disasters. The trauma that disasters impose on our 
children concerns me greatly.
    Senator Hassan. Last, just thank you for pointing out the 
importance of focusing on special needs populations. I am the 
mother of a special needs young man, and I thank you for 
raising that in your testimony very much.
    Dr. Krug. Thank you.
    Senator Hassan. Thank you, Senator Burr.
    Senator Burr. Thank you.
    Senator Smith.
    Senator Smith. Thank you very much, Senator Burr, and 
Senator Casey, and to the other Members of this Committee for 
your work and focus on emergency preparedness, and also to our 
testifiers here today.
    In 2015, when I was Lieutenant Governor, and Minnesota was 
hit by an avian flu outbreak, which ended up costing somewhere 
in the neighborhood of $1 billion, it was the largest and most 
expensive animal disease response in the history, I think, of 
this country. Of course, it hit poultry growers incredibly 
hard.
    Dr. Dreyzehner, I was really relating to what you were 
talking about how this safety net that we have is about people 
and not stuff because certainly as we responded to this 
catastrophe, we needed stuff. But we also really needed the 
people and the relationships that made our response work and 
function incredibly quickly, which was such an important part 
of it.
    I am quite interested in this idea of a One Health approach 
and how we can build that kind of approach into our thinking 
about emergency preparedness. I know that Senator Young from 
Indiana has raised this question just last week and probably, I 
have only been here for 2 weeks, so he has probably been 
talking about it for much longer. But raise this question of 
whether we need additional approaches or resources to do this.
    So maybe I would like to just turn to Dr. Inglesby and also 
Dr. Dreyzehner. Could you talk a little bit about what tweaks 
you think we might need to the PAHPA legislation, and the 
PAHPRA legislation to address this question, this One Health 
approach, what we ought to be doing better there?
    Dr. Inglesby. Yes. First of all, I completely agree with 
the values and principles of One Health and think you are 
absolutely right that there are strong connections between 
animal and human health disease surveillance, outbreaks, 
zoonoses.
    I do think that those principles, you will find those 
principles in Federal agencies. People believe there is a lot 
of acceptance and belief in One Health.
    But I think you are also right that it is not really housed 
in a particular program. There are not large efforts underway 
to try and bring One Health together.
    I do think that there is a national biodefense strategy 
that is now being written, or completed, by the White House and 
its purpose is to bring together animal health, plant health, 
and human health for biodefense. This is the first time a 
strategy has been written that way.
    I do think that there was a lot of coming together in the 
agencies over the last year on this and I think it is improving 
animal surveillance systems. We do not have strong animal 
surveillance. If you talk about shortages in the workforce, the 
human health, public health workforce is strapped and the 
animal public health workforce is even more strapped.
    Taking a look at those things, I am not sure that would be 
in the scope of PAHPA or not, but we do not have a lot of 
information coming from our animal systems. We do not have 
enough information and it does not crossover into human health 
very easily. So trying to create the bridges between the 
systems, that would be a good step.
    Senator Smith. Thank you very much.
    Dr. Dreyzehner.
    Dr. Dreyzehner. Yes, thank you for that great question.
    I think if I can make this point. As public health 
professionals, we think about primary prevention of flu, 
stopping it in the first place as a vaccine, as non-
pharmaceutical interventions.
    But I think we have to look ourselves and we have to think 
about, well, how do you primarily prevent the flu from ever 
occurring in the human population or another disease, for 
example, Ebola, occurring in the human population?
    Well, doing things around the animal sources are critical. 
So the example you gave of avian influenza and stamping out 
avian influenza in poultry, we also have to make sure we circle 
the workers and we circle their families because that is 
primary prevention of a potential novel influenza strain in the 
human population.
    One Health is, I think, an essential perspective and, I 
think, from my perspective, I would say from the Association of 
State and Territorial Health Officials' perspective, a deep 
interest in that.
    Be very happy to work with you on crafting in PAHPA how to, 
specifically as Dr. Inglesby mentioned, bring agriculture 
professionals, public health professionals, the veterinary, the 
health world together to do a better job of keeping animal 
diseases in animal populations and not allowing transfer into 
human beings. Make one other point.
    If somebody had come to Congress years ago and said, ``We 
need some money to teach people how to properly prepare bush 
meat in Africa because we know they are going to eat it and how 
to properly gather fruit that may have been defecated on by 
bats.'' I think that would have been a pretty hard sell.
    But when you consider all the money that we have spent on 
the Ebola outbreak that emanated from those practices, and lack 
of education around that risk, it would have been a relatively 
small investment.
    Senator Smith. Thank you very much, and I look very much 
forward to working with this Committee and Senator Young on 
this issue of One Health. I appreciate it.
    I know I am out of time, but I might also just submit later 
to Dr. Krug. I am very interested in this question of how we 
respond to what is another epidemic seriously affecting 
children, which is the opioid epidemic especially in Indian 
country.
    That will be for a later time, but I would very much 
appreciate your thoughts on that.
    Senator Burr. Senator Roberts.
    Senator Roberts. Thank you, Mr. Chairman.
    I want to thank this Committee, both the ranking Member and 
our distinguished Chairman, for focusing on this issue.
    Last month, over in the Agriculture Committee, we held a 
hearing on safeguarding American agriculture in a globalized 
world. Dr. Inglesby, you really hit the nail on the head with 
your comments.
    One of our witnesses was General Richard Myers, four-star, 
President of Kansas State University, home of the now under 
construction National Bio and Agro-Defense Facility. We call it 
NBAF, for short. You can see why.
    In his testimony, General Myers noted that because there 
were two Homeland Security Presidential Directives, HSPD's, in 
2004--that has been some time ago--one for people, one for 
animals, there does not seem to be as strong of a focus at the 
executive level on crops, and livestock, and food. He suggested 
reasons why this is surprising.
    I will enter his full testimony in the record at this 
point, if that is all right, Mr. Chairman.
    Senator Burr. Without objection.
    Senator Roberts. Thank you.
    [The following information can be found on page 59 in 
Additional Material]
    Senator Roberts. His reasons are, one, essentially every 
country that ever developed an offensive bioweapons program, 
including the U.S., created weapons targeting agriculture as 
well as people.
    I would just like to insert at this time that we have had a 
lot of interest in this by former Senators Sam Nunn and Dick 
Lugar, the old Nunn-Lugar program on pandemic threats; and also 
by Tom Ridge and Joe Lieberman with regards to agro-terrorism.
    I, myself, was in charge, at one time, of Nunn-Lugar 
funding as a Member of the Armed Services Committee. It was 
called the Emerging Threat subcommittee; went to a place called 
Obolensk, which is just north and west of Moscow thereby seeing 
one of the secret cities. We are not allowed in there now, of 
course, but we were then because they needed the money. We were 
focusing on security.
    But in touring that area, I was a little stunned--not a 
little stunned--I was really stunned with regards to vast 
warehouses of pathogens that they were making ready with 
regards to attacking a country's food supply.
    We ran an exercise at that particular time. It was called 
crimson sky. I think it was sort of a misnomer because you do 
not want to burn carcasses or anything like that. But it was 
hoof and mouth disease.
    By the time Texas figured out that they would put a stop 
order from shipping cattle to Oklahoma, or Oklahoma would then 
to Texas say, ``Do not ship any cattle in,'' in Kansas, and 
Nebraska, and South Dakota, and North Dakota, we had an 
epidemic on our hands.
    We had to terminate thousands, if not millions, of cattle. 
All of our exports stopped. I mean, all of our exports stopped. 
There was a run on grocery stores all throughout the country. 
People finally discovered their food did not come from grocery 
stores.
    It took us years to get back to a situation where we could 
literally feed not only this country, but a very troubled and 
hungry world. That was quite an experience for me and that is 
when we started on NBAF.
    The General said first, as I have indicated, every country 
that ever developed an offensive bioweapons program also 
targeted agriculture.
    Two, almost every pandemic threat today is a zoonotic 
disease that can spread from animals to people. Among the 
bioterror threats for which the Department of Homeland Security 
has issued a material threat determination, all except for 
small pox, are zoonotic, meaning they reach humans through 
animals.
    The foreign animal disease threats could really devastate 
public health, as well, according to General Myers' testimony. 
Until NBAF is operational in the next four to 5 years, I regret 
that it is taking that long, there is no U.S. laboratory where 
livestock research can be conducted on Nipah and Ebola, swine 
being a host animal for both.
    Mr. Chairman, I would like to work with you and all of our 
colleagues on this reauthorization, to ensure we are addressing 
and preparing for zoonotic threats.
    I see I have 25 seconds to ask Dr. Inglesby if he would 
like to respond.
    ASPR is responsible for leading the public health emergency 
medical countermeasure enterprise. This is supposed to be where 
all the coordinating agencies--the Department of Defense, the 
V.A., Agriculture, Homeland Security, along with all the first 
responders that are involved, along with HHS--to update our 
strategy and to implement our plan annually.
    From your perspective, are we doing the job?
    Dr. Inglesby. I think we have a lot more work to do in the 
realm of agriculture, food, and crop safety.
    I completely agree with what you said about the importance 
of animal vaccines, the shortage, with the lack of animal 
vaccines to protect herds against some of the most serious 
threats on the planet.
    I agree with what you said about the threat to agriculture 
which, I think, both animal and plants, I think, have been 
relatively neglected over the last 15 years as we have begun to 
do other things around biological defense.
    How to organize that in the government? I do not have a 
strong sense of how that should be organized. I do think it is 
complicated in that the USDA is responsible for the promotion 
of food and the business of food, and it is difficult, and 
perhaps could be difficult, to have all that protection of food 
in the same exact place.
    But I have seen signs of life in the last 6 months around 
those programs that I had not seen in the last five or 10 
years. So perhaps the program is becoming much stronger.
    Senator Roberts. Well, Secretary Perdue and the Agriculture 
Research Service, obviously, would run NBAF. The construction 
of it is the Department of Homeland Security. In fact, they are 
responsible for any attack on the United States.
    It has been very difficult to focus on this. Some years 
back on the Intelligence Committee, of which my distinguished 
friend is the Chairman, we were able to determine that what 
keeps you up at night that at least in the top ten was an 
attack on our food supply.
    That is not the case today. I am talking with our CIA 
Director Mike Pompeo, who happens to be from Kansas. And so, we 
are trying to, at least, reassess that threat and I think it is 
a very real one.
    I thank you all for your service.
    I am over time. I yield back. Thank you, Mr. Chairman.
    Senator Burr. Senator Roberts, you did not disappoint me. I 
knew there was going to be a question somewhere in that 
dissertation.
    [Laughter.]
    Senator Burr. Senator Baldwin.
    Senator Baldwin. Thank you, Chairman Burr and Ranking 
Member Casey.
    This discussion today is important and timely. It brought 
into focus the sobering fact that we have experienced at least 
one health emergency every year in the 5-years that I have been 
serving on this Committee, from Ebola to Zika to the hurricanes 
this year.
    I was serving, previously, in the House of Representatives 
during the 2009 H1N1 pandemic and also in 2004, when we saw a 
dangerous shortage of influenza vaccines due, in part, to our 
insufficient domestic production capabilities.
    We are also in the middle of a particularly severe and 
deadly seasonal flu year. So I wanted to focus especially on 
our readiness for a pandemic flu outbreak.
    I am concerned with the lack of sustained and predictable 
funding for the pandemic vaccine stockpile, and I am committed 
to working with my colleagues to advance a specific 
authorization for pandemic flu activities.
    Mr. MacGregor, in your testimony, I was troubled that our 
pandemic flu stockpile does not match the current strains of 
influenza and is full of expired vaccine components due to 
underfunding. And it is especially concerning as we have the 
H7N9 bird flu circulating in China that continues evolve in 
ways that has the potential to trigger a global pandemic.
    Are we adequately prepared for an outbreak of pandemic flu 
that could strike in the near term? And how would a pandemic in 
the middle of this severe seasonal flu season complicate our 
vaccine readiness?
    Mr. MacGregor. Thank you for the question, Senator.
    I think at the start of your statement, you immediately 
gave part of what would be my answer. I think your question and 
your comment about the stockpile, as it exists today, is a 
result of the underfunding that has occurred, particularly 
since 2009.
    So with the funds that were provided, supplemental balances 
or emergency funds that were provided up to 2009, from 2005 
through to 2009, it allowed for the building up of a stockpile 
of various pandemic strains, pre-pandemic strains allowing us 
to test and to understand how to manufacture. And this was, I 
think, a good partnership with BARDA and was fundamental to our 
preparation at that time.
    Since then, the funding has really dropped off, as you 
commented and that is really what is behind the point I was 
making. There is product that sits in the stockpile today that 
was manufactured quite some time ago, in some cases, seven, 8 
years ago.
    Our ability, and the ability of the government, to 
replenish the stockpile, whether it be with antigen, or whether 
it be with adjuvant, which is also in the stockpile, has been 
diminished by the lack of sustainable funding to support BARDA 
and its efforts.
    I would say in answer to your questions, because of that I 
do not believe we sit in a great state of readiness today. You 
do mention the H7N9 and we are, in fact, working with BARDA on 
developing an H7N9, as I imagine some other partners are as 
well.
    Senator Baldwin. Okay.
    Mr. MacGregor. But we need that sustainable funding going 
forward in order to enhance our readiness.
    Senator Baldwin. This next question is both for you, Mr. 
MacGregor, and Dr. Inglesby.
    My home State of Wisconsin has long been a leader in 
medical innovations that help grow our economy. Not only are we 
home to a world renowned flu scientist working to develop a 
universal vaccine, but we are also the hub for biomedical 
companies producing new technologies.
    Stratatech, a company in Madison, Wisconsin is producing a 
new, regenerative skin technology to treat severe burns through 
a contract with BARDA to develop their tissue as a medical 
countermeasure. Instead of painful skin grafts, they are 
producing living tissue designed to mimic human skin and 
promote tissue regeneration.
    Dr. Inglesby and Mr. MacGregor, can you discuss why it is 
important to maintain our Federal investment in medical 
countermeasure research and development to foster innovation 
that keeps pace with the evolving and increasing chemical and 
biological threats?
    Why do we not start with you, Dr. Inglesby?
    Dr. Inglesby. I think the reason why it is so important to 
continue investment is that for problems, like the one you 
described for patients with burns, for pandemic influenza, for 
other kinds of outbreaks, there is not necessarily a commercial 
market for those products.
    Companies face a very difficult challenge, planning, a lot 
of uncertainty. If the Government can provide more clarity, 
both in the early phases in the research and in the development 
phase--and then potentially in the acquisition phase if that is 
the role for the government for a particular product--companies 
can then plan, can decide to make investments in this space as 
opposed to other commercially valuable opportunities that they 
might pursue otherwise.
    I think it is going to continue to be a very important role 
for the government to play for products that we want that are 
not otherwise produced by the commercial markets.
    Mr. MacGregor. I would certainly echo that comment from Dr. 
Inglesby.
    It is a mechanism that needs to exist to have companies, 
innovative companies--like the one you mentioned and others 
that are Members of the Alliance for Biosecurity and more 
broadly bio--to be able to continue innovating in this space. 
There needs to be sustainable funding in this space.
    The last comment I would make, just to add, it is 
interesting to hear from a number of colleagues in this space 
that, when you look at institutional investors and the like, 
where there used to be more of an attraction for them when the 
funding was more certain, that attraction has gone away. Little 
to no value is placed on MCM work in the current context 
because of the lack of sustainable funding.
    Senator Burr. Senator Cassidy.
    Senator Cassidy. Thank you, gentlemen. I enjoyed your 
testimony, all of you. A couple of things. I enjoyed it so much 
because you agree with me. One of you spoke about the need to 
have healthcare professionals be able to go across lines and 
have liability protection. I was a practicing physician when 
Katrina hit. There was an orthopedist at the New Orleans 
Airport. The FEMA people would not allow him to set somebody's 
broken bones because he was from out of state and they were 
concerned about liability. So I think we need a Good Samaritan, 
which our Governors can say, ``Listen, if you are from out of 
state and you are in good standing with your state, you have 
blanket protection.'' But I do think we need that on a Federal 
level as opposed to the patchwork. I will say that. I have 
introduced a bill with Senator King entitled the Good Samaritan 
Health Professionals Act that would do so. Second, I think Drs. 
Krug and Inglesby, you spoke Dr. Dreyzehner, of the need to 
have a public health emergency fund. Senator Schatz and I have 
introduced something such as that would, just as FEMA has 
dollars, it does not need a special appropriation, but rather 
can go and when an emergency hits, the dollars are 
appropriated, and it cannot be encumbered and put in escrow by 
another effort. Those dollars are there. Still have 
accountability. To get a second trunch, you have to come back 
to Congress and get approval. GAO will make sure they do it. 
But we also take care of contracting because the CDC director 
said of Ebola, he had to get ten signoffs on travel vouchers 
for people to go over to West Africa and that slowed the 
response. He had to contract with NGO's for them to contract to 
get transportation for people and goods. We are trying to 
circumvent that and again, Senator Schatz and I have put 
something together as regard to that. Now, let me hit on some 
stuff which perhaps is a little bit more provocative. Dr. 
Inglesby, you speak about the need to maintain this 
international network. Theoretically, World Health is doing 
that. I am not sure we are getting bang for our buck with World 
Health. Now, you probably have relationships with them, so I do 
not mean to put you in a bad position. But if we are funding 
internationally World Health and the CDC is having to do it 
separately, that does not seem, in a time of scarce resources, 
wise use of resources. Thoughts?
    Dr. Inglesby. Yes, so the World Health Organization has 
some of the best experts in the world on diseases around the 
world, and they are kind of the normative agency for setting 
policy, and guidance around the world, looked up to it in the 
world. But they are not a strong, operational agency. They do 
not have resources to go and train the world or build labs 
around the world. They have some money for that, but their 
budget is constrained as well. They depend on donations.
    Senator Cassidy. If they had the money, do they have the 
capability of doing it?
    Dr. Inglesby. Not right now.
    Senator Cassidy. So, that seems like we are having to 
supplant an international organization with a Centers for 
Disease Control. I understand why we are doing it, but it 
almost seems like we are compensating for something which 
should have the responsibility already.
    Dr. Inglesby. Well, what I would say is that the CDC and 
about 65 other countries are all contributing in some way, some 
of them with a lot of money, some of them with just their 
experts. But the Global Health Security Agenda was a way of 
getting a large consortium of countries go out and help.
    Senator Cassidy. I get that and I am not objecting to it 
except insofar as it seems like World Health should be doing 
that. Let me move on.
    Dr. Inglesby. Okay.
    Senator Cassidy. Now, you mentioned about having regional 
areas of expertise. Let me go back to my formative experience 
with Hurricane Katrina. When the fecal material hit the fan, it 
just overwhelmed everything. Now, when I went to Haiti as a 
private citizen after the earthquake there, I was struck that 
the Israelis came in and they just plopped down a hospital, 
unfolded it, and every capability they needed was there in a 
field hospital. I almost think since a public health emergency 
could happen in Baton Rouge, Shreveport, or Topeka, or you name 
it, how does every region have that kind of expertise? As 
opposed to a public health hospital that may sit up in your 
local V.A., which is already a government facility. Boom. ``We 
commandeered. We are taking it over.'' It almost seems a better 
way to respond because then you would truly have expertise that 
is deployable in a moment. Any thoughts on that?
    Dr. Inglesby. I do think that we should be able to rely on 
the local institutions. So V.A.'s are a great source of 
strength in some cities. But the National Disaster Medical 
System and the DMAT teams, I think, are some of the teams that 
responded to Katrina, they responded to Harvey.
    Senator Cassidy. Let us go back to Ebola, which is very 
specialized. You had to take off your booties in a correct 
fashion or else you were exposed. This happened to the nurse in 
Dallas.
    Dr. Inglesby. Right. So the U.S. was not prepared to send 
doctors and nurses to Ebola. We sent public health specialists, 
but they did not take care of patients. They were not allowed 
to take care of patients.
    Senator Cassidy. But my point is, would it be better to 
have that sort of expertise that truly could go to a community 
and boom. ``We are going to be the expeditionary force.'' I am 
sitting next to a Marine.
    The healthcare expeditionary force that is going to be able 
to manage this and we do not have to have a lot of in-service 
because these people are hitting the door right now. We will 
give you in-service, but in the meantime, we will provide 
direct care and that way, whether it is Baton Rouge or Topeka 
or New York, we know that we have expertise deployed.
    Dr. Inglesby. Yes, I do think it would be very valuable. We 
have something like that on a much smaller scale called the 
DMAT teams.
    Senator Cassidy. Yes, but DMAT is more generic.
    Dr. Inglesby. Fair enough. I agree with you.
    Yes, I do not think we have infectious disease-oriented, or 
Ebola, or contagious disease-oriented teams like the ones you 
are talking about. And I think nationally and internationally, 
it would be good for us to be able to build those teams.
    Senator Cassidy. I yield back. Thank you.
    Senator Burr. I would like the record to show that North 
Carolina tried to deliver to Louisiana after Katrina a portable 
hospital.
    Senator Cassidy. Yes.
    Senator Burr. And it was the Governor who would not sign 
the liability agreement. That put that hospital in Mississippi.
    So we have this incredible surge capacity, I am learning 
about. It is just we have hurdles in the way.
    Senator Cassidy. Right.
    Senator Burr. That will stop it dead in its tracks if it 
ever starts the motion of addressing collectively the problem. 
So these are things we can work out.
    Senator Cassidy. And let me just say we, in Louisiana, 
continue to be indebted to other DMAT's around the Nation who 
just so generously deployed. I cannot tell you the gratitude we 
feel.
    Senator Burr. Senator Kaine.
    Senator Kaine. Thank you, Mr. Chair, and thanks to the 
witnesses.
    An observation and then I want each of you to address a 
workforce question. So the observation is this.
    When we reached a deal yesterday so the Government would 
open, there are really two components to the deal. One, a 
guarantee of a debate and vote around permanent protection for 
Dreamers, which is very important.
    But the second half of it was, we have to get out of 
continuing resolution mania and get back to real budgeting 
again to fund these priorities and others.
    One of the funding questions that we are now grappling with 
is the question of budgetary caps because of votes of earlier 
congresses that would impose such caps. When the caps were 
imposed, they were imposed equally on defense and non-defense.
    All of your testimony, and the testimony of the equivalent 
panel last week, are about national security. This is national 
security.
    I just came from a closed hearing about America's nuclear 
posture in the Armed Services Committee national security, but 
you are national security too.
    One of the proposals floating around is that we would 
increase caps on the defense accounts but not on the non-
defense accounts. You guys are non-defense, so you are national 
security, but you are not defense.
    The Lynchburg, Virginia economy is based pretty heavily on 
companies that build nuclear reactors that go into carriers and 
subs. But those are under the control of the Department of 
Energy, not DOD. So that is a non-defense expenditure.
    The point that I am making is as we grapple with these 
caps, it would be foolish to raise defense caps and non-defense 
caps because if we are not raising caps appropriately to fund 
emergency response, or we are not raising caps appropriately to 
fund the DOE programs that build nuclear reactors, we are not 
taking care of our national security.
    That is my observation.
    Second, workforce. The quote, Dr. Dreyzehner, in your 
testimony, written and verbal, it is about people. It is about 
people. And one of the things I love about this Committee is it 
is Health, Education, Labor, and Pensions. So PAHPA is within 
our Health jurisdiction, but in the Education jurisdiction, we 
are having a set of hearings about approaching the rewrite of 
the Higher Education Act. Programs like public loan service 
forgiveness. This is on the education side.
    You all approach your jobs from different backgrounds and 
expertise, but share any concerns you have about the current 
public health workforce in this country as you look forward 
because we might be able to do something about that, not just 
in PAHPA. We might be able to do some things about that as we 
grapple with the Higher Education Act rewrite.
    If you want to start, Dr. Krug.
    Dr. Krug. Thank you. Thank you for the great question.
    As has already been said, this is about people. Yes, we do 
need more ``stuff,'' but we really need more people. The budget 
environment today constrains the number of people that you can 
employ, which is why there is this just-in-time thing going on 
in healthcare, which is why we do not have a lot of capacity.
    But in the end, there are not enough nurses, as an example, 
to staff all of the hospitals or all of the clinics. And some 
of those limitations are greater in certain communities than 
others. I will defer to my public health colleague, but I 
believe there is a public health workforce issue as well.
    What we need to do through education, and maybe through 
some incentives, is to direct more of our future, young people, 
toward these important careers because these are careers where, 
in addition to taking home a paycheck, you are making a 
difference. You are serving the community. You are serving the 
public. You may not be a special Government employee, but you 
are still making a difference.
    I think if we can redirect the flow, we will be better 
prepared to deal with a calamity.
    Senator Kaine. Others who would like to address it? Mr. 
MacGregor and then Dr. Dreyzehner.
    Mr. MacGregor. We will go down the line quickly.
    Senator Kaine. Yes.
    Mr. MacGregor. I think my main response in this would be 
some of the strain that comes on public health, as referenced 
by my colleagues up here, is the need to respond in an 
emergency.
    I feel that a big part of the reauthorization discussion, 
the notion of sustainable funding really has, at its core, the 
avoidance of having to respond in an emergency that puts an 
undue strain on the public health system.
    It has a bit drifted from your question about workforce, 
but I just wanted to make that particular point, because I 
think it gets to the sustainability question.
    Senator Kaine. Thank you. Dr. Dreyzehner.
    Dr. Dreyzehner. Thank you, Senator. A very important 
question.
    I think Mr. MacGregor said in his comments about medical 
countermeasures and the certainty around having a market for 
those. Dr. Krug mentioned that folks who are engaged in this 
area are highly committed, passionate, compassionate people, 
but they need certainty in the profession being there tomorrow. 
That has not been the case for the last 15 years.
    There have been a lot of question marks raised about, 
``Will the area that I have devoted my life to, when called 
upon, be there?''
    Really after 9/11 and anthrax, we developed our current, I 
think, more modern, more responsive, higher capacity public 
health and healthcare preparedness infrastructure.
    But those professions that have evolved around that, many 
of them are now becoming senior, many of them are retiring. 
People are making decisions as to whether they want to enter 
the field, ``Will there be a profession for me if I decide to 
enter the field or to stay in it?'' So all those things are 
really important.
    Sustaining and maintaining funding is very important, not 
pulling at the last minute to redirect it to some other 
priority is really important. You referenced that briefly.
    I absolutely think your points are really important. I 
think the threat to the public health workforce is they are 
going to decide to go to something else and possibly they will 
retrain into healthcare where there is a little bit more 
stability. They have other options, but they really like these 
jobs.
    These jobs are good jobs. They are important jobs in the 
areas where they exist, both in rural and urban environments. I 
think the Nation's national security would be well served to 
recognize the passion of these professionals, the experience 
that they have gained, the relationships that they have built, 
and the lives and property that they have saved in the last 15 
years since this regime, PAHPA one and two, were reauthorized.
    Senator Kaine. Mr. Chairman, might I ask Dr. Inglesby to 
respond briefly? Thank you.
    Dr. Inglesby. Yes, I would just echo the comments and say 
that the public health emergency preparedness program that 
supports so much of the public health workforce has come down 
pretty substantially since its start. Thousands of jobs have 
been eliminated in public health since we began this effort 
back after 9/11.
    I think there is great excitement in the field. Young 
people want to work on these issues, both in medicine, nursing, 
and public health. They leave schools with pretty substantial 
loans. There are some loan forgiveness programs which need to 
be attended to, to draw people into the field.
    But for the most part, I think people will come to these 
jobs if there is a field there, if there is support there. And 
right now, a lot of this money does come from the Federal 
Government. It supports jobs directly.
    I think continuing these programs would help ensure that we 
have a workforce.
    Senator Kaine. Thank you for that.
    Thank you, Mr. Chair.
    Senator Burr. Senator Young.
    Senator Young. Well, thank you, Chairman, and Ranking 
Member for this second in a series of hearings on a very 
important topic, public health threats.
    I would like to turn to a topic of insurance for pandemics. 
I will be asking a question of each of you related to this 
topic.
    But by way of background, in our last hearing, we heard 
Admiral Redd who, of course, is from the Centers for Disease 
Control and Prevention. He said that our strategy to address 
zoonotic diseases, those that spread from animals to people 
such as Ebola and the avian influenza, has been a reactive 
strategy.
    It made me think. Are there any strategies that might take 
us from a reactive stance to a, to use a modern term, proactive 
one?
    I found that last year, the World Bank launched the first 
pandemic bond to quickly finance public health emergencies. You 
may be familiar with this. So financing emergencies like 
pandemic influenza strains, something called corona viruses, 
filo viruses like Ebola, and others.
    According to the World Bank, their pandemic emergency 
financing facility would provide over $500 million of coverage 
against pandemics in just the next 5 years.
    My question to you is do you think Congress should 
experiment in the creation of similar financing structures like 
the pandemic emergency financing facility, or some other type 
of insurance mechanism to protect against pandemics?
    Regardless of your thoughts on that, if there are other 
proactive strategies that you think we should turn to first, if 
you could volunteer that to me, I would appreciate it. We will 
start with Dr. Inglesby, please.
    Dr. Inglesby. I very much respect what the World Bank has 
done with the pandemic bonds. I have not studied it enough to 
understand whether there would be some value in doing that in 
the United States. It is an interesting and new question. I 
have not heard that before, so maybe I can get back to you with 
thoughts on that.
    I think one alternative, which is less complicated but we 
talked about already, would be to establish a contingency fund 
that would only be used in the event of emergencies declared by 
either Congress of the Secretary of Health. We would have a 
fund that would be ready to go. It is kind of like an insurance 
policy. It would not be called insurance, but a fund available 
for rapid response.
    Senator Young. Thank you. Actually, I have done work like 
this, new financing mechanisms, related to a number of fields 
from healthcare to social policies. So I respectfully am of the 
opinion, this would not be all that complicated. It would be a 
way to capitalize a fund like those that have been invoked 
earlier. But thank you very much, doctor. Yes.
    Dr. Dreyzehner. Well, I would echo Dr. Inglesby's comments.
    I think I am not sure I know what insurance means anymore, 
but the idea that, I think, funding is up in HPP back to their 
prior levels is insurance to make sure that people that need to 
be there when the balloon goes up are there and able to do what 
they do.
    I think the contingency fund could be a very important 
piece of insuring that the unknown unknowns are insured against 
and they will certainly occur.
    I would just echo what Dr. Inglesby said and I would say 
that our best insurance is making sure that we have adequate 
people, and relationships, and networks, and experts available 
at a moment's notice to respond.
    Senator Young. Thank you. Mr. MacGregor.
    Mr. MacGregor. I would just add as well that if mechanisms 
such as these----
    When you first mentioned it, I always thought more of in 
the event of protecting against the cost of pandemic once it 
hits. I would be more inclined toward financing mechanisms 
that, again, allow us to be more prepared in advance and not 
having to deal with the tragic aftermath.
    Maybe just maybe what World Bank is proposing is something 
that could be more of a global kind of effort that cannot only 
benefit the U.S., but can benefit other countries as well. And 
by benefiting other countries, it actually contributes to 
preparedness we can have here.
    Senator Young. Thank you. Doctor.
    Dr. Krug. It is good to be last. I agree with all of the 
comments made by my colleagues. I would offer two, hopefully 
helpful, perspectives.
    First of all, as one of the Members stated, if we could 
mitigate the problem and avoid the disease, that would solve a 
lot of problems, and so, that gets back to proactive 
vaccinations. And also locally and at a global level, looking 
at those vectors and trying to identify early on and prevent 
those diseases before they spread.
    In the end, it is pretty clear to me, and I know you guys 
get this, that there is not money to go around to make this all 
work. We have all told you we need to improve funding for the 
core elements of the process because if you want to do it for 
less, that is what you are going to get. You are going to get 
less and that is what we are seeing today.
    It is long overdue for a discussion with the public about 
the threats that we face, the reality of our resources, and how 
we can collectively make a difference. I think most Americans 
share some common values and I think our collective survival 
and making America stronger is something that most people would 
want to do.
    In the end, there are not enough resources when the cavalry 
arrives, whether it is the state, local, or Federal Government 
to meet the needs of everybody in a town, a city, and whatnot.
    If citizens were better prepared, if we began a discussion 
about the values and the culture with personal readiness and 
with the strong helping the weak, helping your neighbor, making 
sure that is okay, then we would not have to rescue everybody. 
Maybe we would be rescuing a few fewer, because there are going 
to be citizens who cannot do that for a variety of important 
reasons.
    But if we can get back to the culture that, I think, I grew 
up with when I was in grade school where that seemed to be a 
value, I think that would help us both with this and probably 
with some other issues as well.
    Senator Young. Well, I thank you all. I threw a novel 
concept at you. If you have any additional thoughts that you 
would like to followup with my office about later, I would be 
appreciative.
    Mr. Chairman, I would just note that point on community is 
something that has been invoked consistently, whether we are 
talking about the opioid epidemic, or social pathologies, the 
need for more community to help address a range of public 
issues that we are dealing with; so not an easy one to tackle, 
but an important reminder.
    Thank you.
    Senator Burr. Senator Warren.
    Senator Warren. Thank you, Mr. Chairman.
    When a public health emergency hits, the headlines are all 
about what is happening on a minute by minute, hour by hour 
basis. You do not get news alerts on your phone about the years 
of hard work that went into making the response to the disaster 
actually work when everything was on the line; so all the 
drills, the dry runs, the training. But I understand. These are 
the investments that we have to make in our Nation's 
preparedness and our response capabilities if we are going to 
be ready when an emergency strikes.
    I want to talk about one specific type of investment today, 
and that is investing in the therapies, or the medical 
countermeasures, that save lives when disaster strikes; so 
vaccines for anthrax, or Ebola, or influenza; products to 
protect us from radiation exposure; next generation 
antibiotics.
    In 2004, Congress established a program called BioShield, 
and I think Senator Burr referred to this earlier and Senator 
Baldwin. I just want to dig in a little bit about this program. 
The idea was to accelerate development of medical 
countermeasures by investing in biomedical research.
    Now, Dr. Inglesby, you are an expert on biosecurity. When a 
company develops a new drug or device, usually they go out and 
get a lot of funding from private investors.
    Why do medical countermeasures need public investment from 
a program like Project BioShield?
    Dr. Inglesby. Senator, the reason why companies need that 
kind of support from the Government is because the products 
that we are trying to make for pandemics, like an anthrax 
vaccine or an Ebola vaccine that you referred to, they do not 
have a commercial market.
    Senator Warren. We hope.
    Dr. Inglesby. We hope.
    Even in the event of a pandemic, it is going to be 
difficult for people to access those funds without the help of 
government. They are going to be in stockpiles. So what we need 
is sustained investment in those companies to get them to do 
this work.
    Senator Warren. So let us talk about that sustained 
investment.
    When Project BioShield was created, it got $5.6 billion in 
guaranteed funding over 10 years. It was called an advance 
appropriation, and that means that Congress decided, in 
advance, that it was going to spend that amount of money. They 
did not come back every year during that 10 year period to 
decide whether or not they would actually put the money in as 
promised.
    Now that changed in 2013 when the initial 10 year 
commitment ran out and Project BioShield has had to get its 
funds set aside on a yearly basis, just like everyone else, 
through the appropriations process.
    Mr. MacGregor, you work in the biosecurity field at a 
company that makes flu vaccines. The authorization levels for 
Project BioShield, that is what Congress said we could spend on 
it, have stayed exactly the same since 2013.
    Is that right?
    Mr. MacGregor. Yes, since 2013. I mean, the authorization.
    Senator Warren. So authorization, I am going to go to this.
    Mr. MacGregor. Yes.
    Senator Warren. The authorization stays the same, but 
appropriations levels, did Congress actually get that money out 
the door to you?
    Mr. MacGregor. No.
    Senator Warren. No.
    Mr. MacGregor. So for BioShield, I think the authorization 
is $2.8 from Fiscal Year 2014 and about $1.5 billion was 
actually appropriated. So there was a shortfall relative to 
what had been experienced in the initial period.
    Senator Warren. That is a pretty significant shortfall.
    Mr. MacGregor. Yes.
    Senator Warren. All right.
    What does that mean for companies like yours that are 
trying to make decisions about researching and developing these 
kinds of countermeasures?
    Mr. MacGregor. Well, it calls into question again what the 
commitment is and I think for a lot of companies, it is very 
difficult in this space to do long term planning and to 
forecast in a way you would typically forecast, granted, in a 
commercial space. So it makes it very difficult to plan.
    I think as well what has happened with this uncertainty, 
and I know I mentioned it before, but during that initial 10 
year period, I think there was a lot of private investment. 
There was a lot of institutional investment in companies that 
were in the MCM space because there was a value that was seen 
there.
    I have heard from a number of colleagues that investment, 
that pool of investment, has really dried up. And, in actual 
fact, there is really very little of any value that the market 
puts in the MCM space.
    Senator Warren. So this really worries me. You are telling 
me it is a market that only works if the Federal Government 
makes the investment and that the yearly appropriations process 
is not working in this field. I think that is what I am gearing 
from the two of you.
    It just seems to me that keeping our Nation safe from these 
kinds of threats, it is one of the most important investments 
we can make. You cannot make up ground overnight on this, but 
you cannot do it once the threat is at your doorstep. We have 
to be in this for the long haul.
    As this Committee works to reauthorize PAHPA, I hope that 
we can discuss the importance of providing robust, stable 
funding to researchers who are working to help us avert the 
next public health emergency.
    Thank you, Mr. Chairman.
    Senator Burr. Thank you, Senator Warren.
    Let me just say to colleagues, I think Senator Casey and I 
have been in the trenches for a long time. We have written more 
letters to appropriators.
    The definitive change was when Presidential budgets did not 
ask for the full BioShield money; a pivotal point. It was that 
lack of request. And unfortunately up here, as Senator Casey 
and I have found, even our letters to appropriators would not 
get them to fill a hole bigger than what the Presidential 
budget request was, and we have seen this steady decline.
    But I think I can say on behalf of the Chairman, who is an 
appropriator, that this Committee has always said that we ought 
to appropriate at reauthorization levels.
    You probably hit on the key thing that was, I think, the 
toughest thing to recognize, and that is: where is the Federal 
Government's responsibility at creating the incentive for 
people to create something that there is not a commercial 
market for?
    I will say, though, hiding in the back of the room, is one 
of the authors who now works for the ASPR, and she has 
feverishly been writing notes. So everything you have said 
today is going to find its way back.
    But I will tell you how difficult this was. When this was 
originally designed, trying to find somebody to be the 
spokesperson for disaster, we had to create a new position 
called the Assistant Secretary for Preparedness because nobody 
wanted to raise their hand and be in charge.
    This is something that this Committee has got to be 
absolutely vigilant on from a standpoint of what the needs are 
because, I would say, that Mr. MacGregor is a great example. If 
this dries up, who wants to be in the vaccine space? The same 
reason that we have a shortage of antibiotics today, who wants 
to be in the antibiotic space? It is millions, and millions, 
and millions of dollars in development.
    It is not only addressing this, I would tell you it is 
technologically trying to come into the 21st century. And our 
regulatory and reimbursement, as you look at gene-based 
platforms that may cure genetic defects in children on one 
side, and diseases that we have not been able to cure today 
that we can cure tomorrow.
    How do you reimburse for that? You cannot do it based upon 
how much you have put into it. You have to look at it from a 
standpoint of how much we are saving over the life of living 
with that disease. This is foreign to government, but it is 
something that we have to tackle in a bipartisan way to get it 
done.
    Senator Casey and I have just a couple more questions, and 
if Senator Warren has some, I will stick around as long as we 
need to.
    Dr. Krug, identifying emerging public health threats is 
critical in determining how to prevent, treat, and mitigate its 
effect. One of the best tools that we have to gain this 
information is the diagnostic test.
    In the midst of combating Ebola and Zika, determining the 
individuals in need of treatment helped to inform providers, 
and those on the frontlines, of the outbreak.
    How do rapid, point of care diagnostics work to better 
inform providers working and are preparing for these public 
health emergencies?
    Dr. Krug. Thank you. That is a great question. They help 
immeasurably.
    Imagine, for a moment, that you are in a scenario with 
multiple sick victims. And, I think, as one of my colleagues 
pointed out, your Ebola treatment center can maybe take care 
of, at most, three patients. Which of those three patients are 
you going to admit to the Ebola treatment unit?
    With the older technology that we have with diagnostic 
testing, which took over 24 hours back when we dealt with Ebola 
as a treatment center, we had no other choice but to treat 
those patients until we knew for sure that they did not have 
the disease.
    Fortunately, it came during a time of the year where we 
were not operating at peak hospital operating capacity. If that 
was today, I would not know what to do with this problem, 
because I would not know who to treat. And by treating somebody 
who might not actually have the disease and need the treatment, 
essentially prevent somebody else who needs that same treatment 
area and ICU bed, and that ICU care team meeting their need.
    Both in a hospital setting, but also in the field, these 
diagnostics are terribly important. I mean, in the field the 
resources are more limited and so the fundamental decisions 
made in that setting are also vital.
    Senator Burr. Tom, I want to turn to you since Dr. Krug 
mentioned Ebola.
    Is this statement correct? ``We learned enough with the 
Ebola crisis to understand our limitations, but we have done 
nothing to increase our capacity if it were to happen 
tomorrow.''
    Dr. Inglesby. I think at a high level, that is probably 
true. There have been some lessons that have been built into 
the system, but we have not really changed resources that are 
available for the mission.
    Senator Burr. But we learned enough to know that we have 
no, or very little, surge capacity for an infectious disease of 
that magnitude.
    Dr. Inglesby. That is true.
    Senator Burr. Okay. Dr. Krug, let me come back to you.
    From a pediatric standpoint, there have been a number of 
news reports, I do not know the accuracy of them, that suggest 
that young adults taking Tamiflu have had hallucinations.
    How challenging does that make the avenue to try to expand 
these new treatments to the pediatric population?
    Dr. Krug. Well, thanks to that.
    Senator Burr. And the acceptance by parents.
    Dr. Krug. Yes, thank you. You have hit the nail squarely on 
the head.
    It is not just Tamiflu. In fact, the bigger issue is with 
vaccination. Because with the exception of maybe a glass of 
water, there are probably going to be side effects associated 
with almost anything, potentially anything, that you prescribe 
or give to a patient. Whether you use something or not is, 
hopefully, driven by evidence and that risk-benefit ratio of 
positive effects versus side effects.
    Thanks in part to social media, everything that occurs that 
maybe did not occur the way it should have, and reports of 
adults who are having hallucinations with Tamiflu, make their 
way to places. And so that the average family that I care for 
that has a smart phone, they already know about this.
    When I try and advise them that their child should have 
something, and it is driven by CDC guidance and the guidance 
from the American Academy of Pediatrics, they say to me, ``But 
doctor, this medication will cause my child to have four 
heads.'' And it is like, ``Well, I am not even sure that is 
true and if it is true, the likelihood of bad occurrence from 
the disease is probably much more likely than those four heads 
that you are worried about.'' So the point is that does make it 
more difficult.
    I will say that the partnership that we have been able to 
have, and it is not just the American Academy of Pediatrics. 
There are other specialty societies as well in terms of 
partnering with a group like the CDC and getting out guidance, 
not only to practitioners, but information to families. So that 
at least on a reliable Website, there is, perhaps, counter 
information that makes it clear that if your child has an 
underlying medical problem, and they are in their first day of 
illness with the flu that Tamiflu is probably a good idea.
    Senator Burr. The challenging thing is to fulfill your 
wishes, which is increased pediatric indication, you have to 
have children willing to join clinical trials. And that means a 
parent that is willing to allow a child to do that.
    We have done some unusual things by emergency use order, 
but I think you would agree with me that when you take somebody 
who is physically different than what a dose or a drug might 
have been approved for, you just do not know the reaction you 
are going to get.
    There is a real interest in the Committee to make sure that 
pediatric indications are a normal process in the future.
    Dr. Krug. And it should be part of the process. There are 
ethical concerns whenever you are going to enroll a child in a 
trial. The concerns that you have to address are substantially 
greater than adults. And so, again, we are calling on this 
other hat that I have.
    A very interesting discussion was, since we do not know if 
it was going to work, ``Should we try and test the anthrax 
vaccine in children before an anthrax event occurs?'' This was 
back when anthrax was high on the radar screen.
    In the end, we deferred to the Presidential Commission on 
Bioethics, which essentially came to the conclusion that it was 
probably not ethical to do that.
    So that is the dilemma. How do you do that? Again, in an 
industry where it is tough to convince people to develop things 
for which there is no market, the market is even smaller for 
children. And the risk to the industry to do something in 
children is substantially greater. So it is a steeper hill to 
climb.
    Senator Burr. Yes. Brent, I want to turn to you just real 
quick.
    I think it is safe to say that countermeasures are 
difficult things to develop. Those human efficacious studies 
are not feasible in some countermeasures. So the FDA finally, 
in 2015, set the way forward with the animal rule.
    My question is this, what are the challenges in 
successfully bringing forward a medical countermeasure by 
relying on the animal rule as the pathway?
    Mr. MacGregor. Well, it is a different approach for it to 
take from what we are accustomed to. And so, you are reliant on 
the data you generate from that rule being something that you 
have to extrapolate to being of use in humans.
    I think it is beneficial in the sense that it allows us to 
bring medical countermeasures forward. So in that regard, it is 
good.
    It is a rule that we have had, as an industry, to adapt to 
going forward, but I think as an industry, we are doing it. So 
it has been a good step forward.
    Senator Burr. Senator Casey.
    Senator Casey. Mr. Chairman, thank you very much.
    I wanted to continue on the topic of children. I know we 
are almost out of time here. But Dr. Krug, in the last 
reauthorization, we were able to put in place a new,
    National Advisory Committee on Children and Disasters, and 
appreciate your work and your testimony today.
    The only question I have for you is, what are the areas of 
our preparedness planning where you see the greatest need for 
more attention to the needs of children?
    I know you have answered different parts of this, but at 
least my wrap up would be there.
    Dr. Krug. Well, arguably in all facets. And again, we have 
made tremendous progress and the National Advisory Committee 
has certainly contributed in that direction.
    From a healthcare perspective--and that is a narrow 
perspective because the whole process is bigger than 
healthcare--the healthcare industry is primarily put together 
to take care of somebody like me. Somebody not a child, 
somebody with underlying medical problems, toward the end of 
their life, I hope not.
    The point is that with the exception of the facilities, and 
there are a smaller number that sort of specialize in children, 
the rest of the system does not. There is nothing wrong with 
it. That is how it works on a day to day basis.
    We can build these specialty centers of greatness for 
disaster response, but every community, every institution, 
every clinic--because that is where the care may need to be 
provided--needs to be prepared to take care of all comers in 
the community. And that also, then, includes children.
    In current operations, if you have a sick child, you put 
them in an ambulance and you send them to the children's 
hospital. Well, that is not going to work, first of all, if the 
children's hospital has been disabled by the event, or the 
nature of the disaster does not permit transportation, or 
everything is fine but they are already full to the gills.
    So the challenge that we have, and the good thing is 
everybody likes children, so that is our little thing in our 
pocket. We have to get everybody better prepared to take care 
of children and one of the most important ways to get there is 
through training. Drilling and training, I think, would make us 
better in caring for all populations, and certainly for 
children.
    Senator Casey. Thanks very much.
    Thanks, Mr. Chairman.
    Senator Burr. Thank you, Senator Casey.
    Thank you to our witnesses. I do want to highlight, just 
once again. In 24 years, I have done a lot of hearings. I found 
it almost impossible to have an agency witness at the table who 
testified and the private panel comes up second, and get an 
agency person to stay in the room to listen to the private 
sector.
    This may be the first time I have looked and we have not 
had a government witness, but we have had agency folks who have 
attended to hear what the Members and the private sector say 
about the reauthorization of a program.
    That is unusual. I hope it is a trend that is going to 
become the norm and not the exception. And I say that as a 
message to go back because I think your testimony is not only 
valuable to us, it is valuable to the agencies that are 
affected by the issues that you are here to talk about.
    So I want you to know today, they got heard not just by us, 
but by the agency itself.
    I thank all four of you for your willingness to be here 
today and for the insight that you have provided to the 
Committee.
    The hearing record will remain open for 10 days. Members 
may submit additional information within that time, if they 
would like.
    [The information referred to follows]

                          ADDITIONAL MATERIAL

               prepared statement of richard b. myers \1\
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    \1\  General (Ret.), 15th Chairman of the Joint Chiefs of Staff
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    Chairman Roberts, Ranking Member Stabenow, and distinguished 
Members of the Committee, I am honored to appear before you today on 
behalf of Kansas State University (K-State) for this hearing entitled, 
``Safeguarding American Agriculture in a Globalized World.''
                        THREATS AND CONSEQUENCES
    Food insecurity is an ever increasing global problem as delineated 
in a 2015 assessment by the intelligence community. \2\ Hungry people 
are not happy people. America still feeds the world, so there is an 
urgent need to protect America's food crops, food animals, and food 
supply from naturally occurring and intentionally delivered biological 
threats. Either could be devastating.
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    \2\  Intelligence Community Assessment: Global Food Security, ICA 
2015-04; September 2015
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    One of the early discoveries when our troops went into Afghanistan 
in 2002 was a list of 16 pathogens al-Qaeda was planning to use as 
bioweapons. Only 6 of them targeted people. Another 6 were pathogens of 
livestock and poultry and 4 were crop pathogens. So, al-Qaeda wasn't 
just planning to attack people with biological weapons; they were going 
after agriculture and food as well.
    al-Qaeda has always had a goal of destroying the U.S. economy, so 
bioweapons targeting crops, livestock and poultry is consistent with 
that objective. Moreover, natural infectious disease outbreaks could 
lead to the same outcome.
    Consider the United Nations (UN) Food and Agriculture Organization 
(FAO) assessment that ``just 15 crop plants provide 90 percent of the 
world's food energy intake, with three--wheat, rice, and maize--making 
up two-thirds of this.'' \3\ Ninety percent makes the protection of 
food crops rather significant.
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    \3\  See United Nations Food and Agriculture Organization: http://
www.fao.org/docrep/u8480e/u8480e07.htm
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    If wheat, rice, or corn are targeted successfully by al Qaeda or 
other bioterrorists or if there's a natural disease outbreak that 
devastates the global supply of any one of the three, the world will be 
in big trouble. The Wheat State takes such matters seriously.
    Although it didn't turn out to be a global disaster, the pathogen 
Wheat Blast hitting Bangladesh in 2016 certainly wreaked havoc there. 
Wheat Blast can kill 100 percent of crops, and it likely got to 
Bangladesh in a shipment of grain from South America where it's 
endemic. The outcomes were devastating in areas of the country where it 
occurred, and even though infected fields were burned, there was a 
recurrence in 2017; the new outbreak spread to India too. The U.S. 
should consider restricting grain shipments here from South America to 
avoid a similar outcome.
    With livestock, the Porcine Epidemic Diarrhea virus (PEDv) foreign 
animal disease (FAD) outbreak in the U.S. in 2013 highlighted 
biosecurity problems here that must be addressed. It resulted in over 8 
million baby pigs dying, and significant financial losses incurred by 
producers drove up the cost of pork markedly. It's suspected PEDv came 
to the U.S. in feed products from China, but the FBI still hasn't 
confirmed whether the virus got here by accident or intentionally. 
There are reasons to suspect the latter. Either way, the impacts were 
substantial, and PEDv is now an enduring endemic problem to deal with 
in the U.S., not a FAD threat.
    There are innumerable FAD threats that the U.S. must worry about 
today, and the top-line FAD concerns are those currently projected to 
be worked on in the U.S. Department of Homeland Security's (DHS's) 
$1.25 billion National Bio and Agro-defense Facility (NBAF) under 
construction on the K-State campus. These include the livestock-only 
threats, African Swine Fever (ASF), Classical Swine Fever (CSF), and 
Foot and Mouth Disease (FMD), along with the zoonotic threats, Rift 
Valley Fever (RVF), Japanese Encephalitis (JE), Nipah virus, and Ebola 
virus. Any of these and innumerable other FADs could ravage America's 
agricultural infrastructure, food supply, and economy if they hit the 
U.S. Furthermore, zoonotic FADs could devastate public health as well, 
and until NBAF is operational in 2022/23, there's no U.S. laboratory 
where livestock research can be conducted on Nipah and Ebola.
                          FOUNDATIONAL EFFORTS

    Defense of U.S. Agriculture and Food--Homeland Security 
Presidential Directive/HSPD-94

    Delineating the federal role in bio/agrodefense post-09/11, 
President Bush issued Homeland Security Presidential Directive/HSPD-9, 
on January 30, 2004 to establish: ``a national policy to defend the 
agriculture and food system against terrorist attacks, major disasters, 
and other emergencies.'' \4\ Along with a number of other systems vital 
to U.S. survival and prosperity, the agriculture and food sector was 
appropriately noted to be ``critical infrastructure.'' \5\
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    \4\  Homeland Security Presidential Directive/HSPD-9--Defense of 
United States Agriculture and Food; Jan. 30, 2004
    \5\  As delineated in Section 1016(e) of the USA PATRIOT Act of 
2001 [42 U.S.C. 5195c(e)]

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    HSPD-9 Roles and Responsibilities:

    A defined chain of command is critical to accomplish any national 
security mission. That's true for bio/agrodefense--defending the 
homeland agriculture and food system--just as it is for every other 
aspect of national defense. The leadership roles per HSPD-9 are as 
follows:
      Secretary of Homeland Security. As established in HSPD-7, 
\6\ the Secretary of the Department of Homeland Security (DHS) ``is 
responsible for coordinating the overall national effort to enhance the 
protection of critical infrastructure and key resources of the United 
States.''
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    \6\  Homeland Security Presidential Directive/HSPD-7--Critical 
Infrastructure Identification, Prioritization, and Protection, December 
17, 2003
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      Secretaries of Agriculture, Health and Human Services and 
the Administrator of the Environmental Protection Agency. The two 
Secretaries and the Administrator ``will perform their responsibilities 
as Sector-Specific Agencies as delineated in HSPD-7:'' \7\
---------------------------------------------------------------------------
    \7\  Homeland Security Presidential Directive/HSPD-7--Critical 
Infrastructure Identification, Prioritization, and Protection, December 
17, 2003
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      For the U.S. Department of Agriculture (USDA), sector-
specific responsibilities mean agriculture and food (meat, poultry, and 
egg products);
      For the Department of Health and Human Services (DHHS), 
it means public health, healthcare, and food (other than meat, poultry, 
and egg products); and
      For the Environmental Protection Agency, sector-specific 
means drinking water and water treatment systems.
    Thus, DHS was named to lead bio/agrodefense, with USDA, DHHS, and 
EPA supporting. Other departments and agencies also provide support 
with the HSPD-9 requirements that follow.

    HSPD-9 Requirements:

      ``Awareness and Warning'' \8\ . Knowing what's happening 
over-the-horizon--beyond U.S. borders--is vital if America is to be 
prepared to confront emerging biological threats; if the U.S. is to 
respond quickly and decisively to defeat the threat.
---------------------------------------------------------------------------
    \8\  Homeland Security Presidential Directive/HSPD-9--Defense of 
United States Agriculture and Food; Jan. 30, 2004
---------------------------------------------------------------------------
      HSPD-9 required the development of ``robust, 
comprehensive, and fully coordinated surveillance and monitoring 
systems'' for diseases of animals, plants, wildlife and people along 
with threats to food and water quality. This system was to include 
nationwide diagnostic networks for ``food, veterinary, plant health and 
water quality.'' The Department of the Interior (DOI), USDA, DHHS, EPA 
and other departments and agencies would develop the systems.
      HSPD-9 required ``intelligence operations and analysis 
capabilities focusing on agriculture, food, and water sectors.'' This 
would be led by the Attorney General/ Department of Justice (DOJ), DHS, 
and the Central Intelligence Agency (CIA) in coordination with USDA, 
DHHS, and EPA.
      HSPD-9 required the creation of ``a new biological threat 
awareness capacity that will enhance detection and characterization of 
an attack.'' DHS was to coordinate with USDA, DHHS, EPA and other 
departments and agencies to carry this out.
      ``Vulnerability Assessments''. HSPD-9 mandated 
``vulnerability assessments of the agriculture and food sectors'' and 
the identification of ``requirements for the National Infrastructure 
Protection Plan'' that was to be updated every 2 years. The assessments 
would be done by USDA, DHHS, and DHS, with DHS responsible for the plan 
every 2 years.
      ``Mitigation Strategies''. HSPD-99 required:
      The prioritization, development, and implementation of 
``mitigation strategies to protect vulnerable critical nodes of 
production or processing from the introduction of diseases, pests, or 
poisonous agents.'' \9\ This was a responsibility of DHS and DOJ 
working with USDA, DHHS, EPA, and other departments and agencies.
---------------------------------------------------------------------------
    \9\  Homeland Security Presidential Directive/HSPD-9--Defense of 
United States Agriculture and Food; Jan. 30, 2004
---------------------------------------------------------------------------
      The development of ``common screening and inspection 
procedures for agriculture and food items entering the United States'' 
and maximizing ``effective domestic inspection activities for food 
items within the United States.'' This was a responsibility of USDA, 
DHHS, and DHS.

    ``Response Planning and Recovery''. HSPD-9 required:

      Ensuring ``that the combined federal, state, and local 
response capabilities are adequate to respond quickly and effectively 
to a terrorist attack, major disease outbreak, or other disaster 
affecting the national agriculture or food infrastructure.'' This was a 
responsibility of DHS in coordination with USDA, DHHS, DOJ, and EPA.
      Developing ``a coordinated agriculture and food-specific 
standardized response plan that will be integrated into the National 
Response Plan.'' This was a responsibility of DHS in coordination with 
USDA, DHHS, DOJ and EPA.
      Enhancing ``recovery systems that are able to stabilize 
agriculture production, the food supply, and the economy, rapidly 
remove and effectively dispose of contaminated agriculture and food 
products or infected plants and animals, and decontaminate premises.'' 
This was a responsibility of USDA and DHHS in coordination with DHS and 
EPA.
      Making ``recommendations to the Homeland Security 
Council, within 120 days of the date of this directive, for the use of 
existing, and the creation of new, financial risk management tools 
encouraging self-protection for agriculture and food enterprises 
vulnerable to losses due to terrorism.'' This was a responsibility of 
USDA.
      Working with state and local governments and the private 
sector to develop:
          ``A National Veterinary Stockpile (NVS) containing 
        sufficient amounts of animal vaccine, antiviral, or therapeutic 
        products to appropriately respond to the most damaging animal 
        diseases affecting human health and the economy and that will 
        be capable of deployment within 24 hours of an outbreak.''
          ``A National Plant Disease Recovery System (NPDRS) 
        capable of responding to a high-consequence plant disease with 
        pest control measures and the use of resistant seed varieties 
        within a single growing season to sustain a reasonable level of 
        production for economically important crops.''
    Both were requirements of USDA in coordination with DHS and in 
consultation with DHHS and EPA.

    ``Outreach and Professional Development''. HSPD-9 specified that 
the Secretaries shall:

      Work ``with appropriate private sector entities to 
establish an effective information sharing and analysis mechanism for 
agriculture and food.'' This was a responsibility of DHS in 
coordination with USDA, DHHS and other appropriate departments and 
agencies.
      Support ``the development of and promote higher education 
programs for the protection of animal, plant, and public health.'' \10\ 
This was a responsibility of USDA and DHHS in consultation with DHS and 
the Department of Education (ED).
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    \10\  Homeland Security Presidential Directive/HSPD-9--Defense of 
United States Agriculture and Food; Jan. 30, 2004
---------------------------------------------------------------------------
      Support the development of and promotion of ``a higher 
education program to address protection of the food supply.'' This was 
a responsibility of USDA and DHHS in consultation with DHS and ED.
      Establish ``opportunities for professional development 
and specialized training in agriculture and food protection, such as 
internships, fellowships, and other postgraduate opportunities that 
provide for homeland security professional workforce needs.'' This was 
a responsibility of USDA and DHHS.

    ``Research and Development''. HSPD-9 required:

      Accelerating and expanding ``development of current and 
new countermeasures against the intentional introduction or natural 
occurrence of catastrophic animal, plant, and zoonotic diseases.'' This 
was a responsibility of DHS, USDA, DHHS, EPA and other appropriate 
departments and agencies in consultation with the Director of the 
Office of Science and Technology Policy (OSTP), with DHS coordinating 
the efforts.
      Developing ``a plan to provide safe, secure, and state-
of-the-art agriculture biocontainment laboratories that research and 
develop diagnostic capabilities for foreign animal and zoonotic 
diseases.''This was a responsibility of USDA and DHS; DHS constructing 
the National Bio and Agro-defense Facility (NBAF) meets this 
requirement.
      Establishing ``university-based centers of excellence in 
agriculture and food security.''This was a responsibility of DHS in 
consultation with USDA and DHHS, but funding for these centers has been 
terminated by DHS.
    The summary above does not include all the details in HSPD-9, but 
it does note departments and agencies responsible for each requirement. 
For almost every task, there were multiple departments and agencies 
involved which would make every task very complex. Nonetheless, all six 
requirements are vitally important to protecting U.S. agriculture and 
food.

    Separating HSPD-9 from HSPD-10--Bioterrorism for the 21st Century 
\11\

    \11\  Homeland Security Presidential Directive/HSPD-10--Biodefense 
for the 21st Century, April 28, 2004

    As already noted, HSPD-9--protecting agriculture and food from 
bioterrorism--was signed on January 30, 2004, while HSPD-10--protecting 
people from bioterrorism--was finalized on April 28, 2004. There were 
likely sound reasons in 2004 to separate bioweapon threats to people 
from bioweapon threats to agriculture and food, but the result of that 
over the past decade and a half is that agriculture and food have 
received minimal biodefense attention or funding.
    That's surprising for at least two reasons: (1) Essentially every 
country that ever developed an offensive bioweapons program, including 
the U.S., created weapons targeting agriculture as well as people; and 
(2) almost every pandemic threat today is a zoonotic disease that can 
spread from animals to people. As a result, significant federal funding 
should be focused on confronting and stopping these threats in the 
animal host; that's not being done.
    The only statement regarding agriculture and food in HSPD-10 
referenced ``new programs to secure and defend our agriculture and food 
systems against biological contamination.'' \12\ That's basically 
delineating a food safety role as a small part of HSPD-10. And, in 
fact, it was HSPD-7 that outlined homeland security obligations 
regarding food safety. \13\ Responsibilities for meat, poultry, and egg 
products went to USDA; the agency responsible for inspecting those 
processing activities. Inspections for everything other than meat, 
poultry, and egg products is the responsibility of the Food and Drug 
Administration (FDA); a component within DHHS.
---------------------------------------------------------------------------
    \12\  Homeland Security Presidential Directive/HSPD-10--Biodefense 
for the 21st Century, April 28, 2004
    \13\  Homeland Security Presidential Directive/HSPD-7--Critical 
Infrastructure Identification, Prioritization, and Protection, December 
17, 2003
---------------------------------------------------------------------------
    That might actually explain some of the disparities between HSPD-9 
and HSPD-10, e.g., why HSPD-10 specifies ``increased funding for 
bioterrorism research within DHHS by thirty-fold''to protect human 
health, while USDA got nothing for bio/agroterrorism research within 
HSPD-9 to protect plant and animal health. Food was delineated by food 
processing responsibilities for USDA and DHHS/FDA, with little focus on 
safeguarding agriculture pre-harvest activities, i.e., protecting food 
crops or food animals from infectious diseases or bioweapons. Thus, 
USDA and DHHS have nearly equal roles in HSPD-9 (with DHS leading), 
while DHHS has an appropriately dominant role in HSPD-10 (also with DHS 
leading) with USDA having a minor food safety role.
    Infectious diseases and biological weapons target living things, 
people, plants, and animals. As noted above, bioweapon programs 
commonly included pathogens of plants and animals, not just people. 
Why? Because food-deprived or starving people are generally less fit to 
fight and more likely to surrender.
    Evidently, al Qaeda knew this, since their bioweapons list included 
10 pathogens targeting animals and plants, and only 6 targeting people.

    U.S. Bio/Agrodefense Status Today

    U.S. biodefense efforts have been lacking for decades as pointed 
out in multiple reports; first by the Commission on the Prevention of 
Weapons of Mass Destruction (WMD) Proliferation and Terrorism, \14\, 
\15\ and then by the bipartisan Blue Ribbon Study Panel on Biodefense. 
\16\, \17\ The Commission looked at all WMD threats, and in their 2010 
report card, biological risks received a failing grade; an ``F.'' All 
four citations concentrated on biothreats to people, although the Blue 
Ribbon reports referenced threats to animals, primarily from a ``One 
Health'' perspective. The 2015 Blue Ribbon \18\ report highlighted 
thirty-three major shortcomings requiring urgent attention by 
Washington, DC policymakers. The top three most problematic were: (1) 
no national leader; (2) no strategic plan; and (3) no dedicated budget. 
Unfortunately, none of these shortcomings have yet been corrected.
---------------------------------------------------------------------------
    \14\  The Clock is Ticking: A Progress Report on America's 
Preparedness to Prevent Weapons of Mass Destruction Proliferation and 
Terrorism; Commission on the Prevention of Weapons of Mass Destruction 
Proliferation and Terrorism, October 21, 2009
    \15\  Prevention of WMD Proliferation and Terrorism Report Card; 
Commission on the Prevention of Weapons of Mass Destruction 
Proliferation and Terrorism, January, 2010
    \16\  A National Blueprint for Biodefense: Leadership and Major 
Reform Needed to Optimize Efforts; A Bipartisan Report of the Blue 
Ribbon Study Panel on Biodefense, October 2015
    \17\  Biodefense Indicators: One Year Later, Events Outpacing 
Federal Efforts to Defend the Nation; A Bipartisan Report of the Blue 
Ribbon Study Panel on Biodefense, December 2016
    \18\  A National Blueprint for Biodefense: Leadership and Major 
Reform Needed to Optimize Efforts; A Bipartisan Report of the Blue 
Ribbon Study Panel on Biodefense, October 2015
---------------------------------------------------------------------------
    Since few elements dealt with agriculture, K-State raised the bio/
agrodefense issue with Blue Ribbon Panel Members. That led to a Panel 
hearing on the K-State campus on January 26, 2017. The outcome of that 
was a special focus report entitled, ``Defense of Animal Agriculture.'' 
\19\ Since Senator Lieberman will be covering Blue Ribbon reports, the 
only other issue that should be noted from the hearing at K-State is 
that defense of plant agriculture was discussed as well. It's our 
understanding those threats will be addressed in a separate report.

    \19\  Special Focus: Defense of Animal Agriculture; Bipartisan 
Report of the Blue Ribbon Study Panel on Biodefense, October 2015

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    Bio/Agrodefense Focus at K-State

    As the Committee knows, protecting U.S. agriculture is a mission of 
America's land-grant universities; that began in 1862 when President 
Lincoln signed the Morrill Act. As someone relatively new to land-grant 
administration--but someone with a lifelong commitment to national 
defense --I'm convinced that the Nation's land-grant universities can 
and should play a significant role in U.S. bio/agrodefense. These 
institutions participate in protecting agriculture and food in their 
states each and every day.
    Thus, we would encourage the Committee to integrate the land-grant 
universities into whatever solutions are developed. K-State stands 
ready to participate on the national team and lead when asked or when 
necessary. Protecting America's agriculture and food infrastructure is 
too important not to.
    K-State is not new to this realm. Back in 1999 with encouragement 
from the Chairman of this Committee, K-State developed a 100-page 
``Homeland Defense Food Safety, Security, and Emergency Preparedness 
Program'' \20\ that detailed how to protect America's food crops, food 
animals, and food supply from biothreats. Later that year, K-State's 
President Jon Wefald testified before the U.S. Senate's Emerging 
Threats Subcommittee regarding the ``Agricultural Biological Weapons 
Threat'' \21\ facing America. That Senate subcommitee was also chaired 
by Kansas Senator Pat Roberts.
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    \20\  Homeland Defense Food Safety, Security, and Emergency 
Preparedness Program, March 22, 1999. See:http://www.k-State.edu/nbaf/
documents/1999-Homeland-Defense-Program.pdf
    \21\  Agricultural Biological Weapons Threat, October 27, 1999. 
See: http://www.k-State.edu/nbaf/documents/1999-US-Senate-Testimony.pdf
---------------------------------------------------------------------------
    The ``Big Purple Book,'' as the 1999 program became known, 
documented the need for a biocontainment facility capable of conducting 
R&D on biothreats to food crops, food animals, and the food supply. 
Prior to September 11th and the anthrax attacks in 2001, little 
traction was gained for the need to build it. Post-09/11/2001, state 
and federal funding was obtained, and the Biosecurity Research 
Institute (BRI) at Pat Roberts Hall (PRH) became a reality.
    The BRI/PRH is located immediately adjacent to the NBAF site and it 
includes five BSL-3Ag rooms that can be configured for research with 
cattle, pigs, sheep, goats and poultry. Work has been done on numerous 
species to date, including white-tailed deer in 2017 to determine their 
susceptibility to RVF. In addition to BSL-3Ag labs, the BRI/PRH has 
dedicated BSL-3 space for conducting research on crop and food 
pathogens. Wheat Blast R&D has been ongoing since 2009 and food safety 
research began soon thereafter. The latter included studies for the 
Army whereby eight 1-ton grinds of hamburger were done in October 2011 
to validate whether food pathogens could be detected at the end of a 
commercial process. The breadth of food-related biocontainment R&D 
conducted under one roof makes the BRI/PRH unique-in-the-world.
    K-State jump-started NBAF research in the BRI/PRH on RVF in 2013, 
JE in 2014, CSF in 2015, and ASF in 2016. We were able to do this 
because the State of Kansas agreed to fund $35 million for NBAF 
research in the BRI/PRH as part of our ``best and final offer'' for 
NBAF during the site selection competition. Research and development 
(R&D) continues on all four of these FADs, but the Kansas funding 
commitment will end in fiscal year 2019 when the last $5 million is 
appropriated. The majority of the research is conducted by K-State 
faculty, staff and students, but collaborators from the U.S. Department 
of Agriculture's (USDA's) Center for Grain and Animal Health Research 
(CGAHR) in Manhattan participate on some of the NBAF-related FAD 
projects. Moreover, CGAHR conducts other USDA BSL-3/3Ag biocontainment 
research in K-State's BRI/PRH as well. Going forward, federal support 
is needed for R&D on RVF, JE, CSF, and ASF to help mitigate these 
threats to U.S. animal health and public health.
    Until NBAF is fully operational in 2022/23, USDA has no 
biocontainment facilities where R&D can be conducted on zoonotic FADs. 
Moreover, DHS stopped funding CSF and ASF research in 2017 at the Plum 
Island Animal Disease Center (PIADC); an antiquated facility unsafe for 
work with zoonotic diseases. Consequently, training the NBAF R&D 
workforce is highly reliant on the BRI/PRH until the new DHS facility 
becomes operational.
                         PROPOSED PATH FORWARD
    The importance of implementing the requirements outlined in HSPD-9 
\22\ to safeguarding American agriculture in a globalized world cannot 
be overstated. They are all critically important, but strides made to 
implement them in the early years have eroded today.
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    \22\  Homeland Security Presidential Directive/HSPD-9--Defense of 
United States Agriculture and Food; Jan. 30, 2004
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    K-State believes that statutory authorization--with clearly 
delineated and enforceable accountability--along with the appropriation 
of funds to support the following key provisions in HSPD-9 will advance 
this crucial humanitarian and economic mission.
    (1) Enhance Intelligence Operations and Analysis Capabilities--
Leverage ``awareness and warning''intelligence information to conduct 
federal, state, and local agriculture and food ``vulnerability 
assessments.'' Advanced warning of over-the-horizon biothreats is 
vital, but today, the U.S. is often minimally aware and insufficiently 
warned. One reason appears to be insufficient numbers of bio/
agrodefense subject matter experts (SMEs)--veterinarians, animal 
scientists, crop scientists, plant pathologists, etc.--with high-level 
security clearances to assess classified intelligence.
    (a) Security Clearances--Increase the number of food crop, food 
animal, and food supply SMEs with high-level security clearances (TS-
SCI) to monitor bio/agrodefense threats worldwide.
    (b) Sensitive Compartmented Information Facilities (SCIFs)--
Increase the number of SCIFs with secure communications that have 
agriculture/food SME analysts and/or cleared SME advisors with TS-SCI 
clearances.
    (c) USDA Clearances--Increase the number of USDA personnel with TS-
SCI clearances. It's unknown how many bio/agrodefense SMEs there are 
within the intelligence agencies, but there are nowhere near enough 
within USDA. Conversations in 2016 with the USDA's chief scientist and 
a USDA intelligence analyst confirmed their frustrations with an 
inability to convey critical classified information within USDA to make 
it actionable. This creates huge federal impediments to safeguarding 
agriculture, particularly when DHS stopped meeting their HSPD-9 
responsibilities in 2016/17. Undertaking ``vulnerability assessments,'' 
\23\ developing ``mitigation strategies,'' conducting ``response 
planning and recovery,'' and defining time-critical ``research and 
development'' strategies are virtually impossible when there is limited 
awareness and no warning. This must be rectified immediately.
---------------------------------------------------------------------------
    \23\  Homeland Security Presidential Directive/HSPD-9--Defense of 
United States Agriculture and Food; Jan. 30, 2004
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    (d) Intelligence Fusion Centers (IFCs)--Increase the number of 
state IFCs with agriculture and food SMEs with TS-SCI clearances. The 
Kansas IFC (KIFC) appears to be the only such center of over 70 
nationwide that has a biothreat team with cleared SMEs capable of 
assessing the full range of biohazards to food crops, food animals, the 
food supply, and people. These include a DVM and PhDs from K-State and 
MDs from the University of Kansas Medical Center as well as SMEs from 
multiple state agencies. These SMEs allow the KIFC to assess global 
intelligence for the purpose of preventing bioterrorism attacks and 
preparing for natural infectious disease events emerging globally. 
Thus, the KIFC focuses ``left of boom'' (prior to an attack or 
outbreak) rather than ``right of boom'' (after the event) like other 
fusion centers. This model should be emulated beyond Kansas, because it 
allows state-specific planning with regard to ``vulnerability 
assessments, mitigation strategies, and response planning and 
recovery.''
    (2) Emerging FAD Threats--Exploit ``awareness and 
warning''telligence information regarding newly emerging biothreats to 
establish bio/agrodefense ``mitigation strategies''at USDA CGAHR prior 
to NBAF becoming operational and fund ``research and development''in 
the BRI/PRH.
    (3) Zoonotic Animal Disease Research--Establish federal threat 
``mitigation strategies'' \24\ for zoonotic FADs at USDA CGAHR prior to 
NBAF becoming operational and fund RVF and JE ``research and 
development''in the BRI/PRH.
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    \24\  Homeland Security Presidential Directive/HSPD-9--Defense of 
United States Agriculture and Food; Jan. 30, 2004
---------------------------------------------------------------------------
    (4) Non-Zoonotic Foreign Animal Disease Research--Expedite federal 
threat ``mitigation strategies''for non-zoonotic FADs by moving the 
research portfolios for ASF and CSF from USDA PIADC to CGAHR and 
funding ASF and CSF ``research and development''in the BRI/PRH until 
NBAF becomes operational.
    (5) Private-Sector Outreach--Enhance private-sector ``outreach and 
professional development''by leveraging the Nation's land-grant 
universities that interact routinely with private-sector agriculture 
producers and food processors nationwide.
    An implementation problem for HSPD-9 was the expectation that the 
Federal Government would be able ``to establish an effective 
information sharing and analysis mechanism''with private-sector 
agriculture producers and food processors. Having the Federal 
Government show up at the door is likely to be viewed with distrust and 
skepticism. In some instances, State Government might be a somewhat 
better alternative, but this is an area where the Nation's land-grant 
universities could serve as the facilitators/trusted brokers.
    (6) Higher Education Programs--Support the development of higher 
education programs as called for in HSPD-9 ``outreach and professional 
development.''
    (a)
    For Capacity Building--`In veterinary medicine, public health, and 
agriculture.''
    (b) For Protection--``Of the food supply.''
    (7) Surveillance Systems--Increase support for ``awareness and 
warning'' surveillance systems to provide early detection of U.S. 
disease outbreaks.
    (a) For Food Animals--the National Animal Health Laboratory Network 
(NAHLN)
    (b) For Food Crops--the National Plant Diagnostic Network (NPDN)
    (c) For Wildlife--Unknown
    (8) Agriculture Response and Recovery--Support agriculture/food 
``response planning and recovery''systems for the purpose of 
reestablishing full operations following infectious disease outbreaks.
    (a) For Food Animals--By utilizing and expanding the USDA National 
Veterinary Stockpile (antigen bank) as called for in HSPD-9 ``response 
planning and recovery''and endorsed by livestock producer groups and 
animal health companies.
    (b) For Food Crops--By designing a National Plant Disease Recovery 
System as called for in HSPD-9 ``response planning and recovery'' and 
endorsed by crop producer groups and related stakeholders.
    (9) FAD Advance Development and Manufacturing (ADM)--Improve 
``response planning and recovery'' \25\ by creating FAD ADM 
capabilities for producing vaccines and other countermeasures against 
livestock-only and zoonotic FADs similar to ADM capabilities for human 
infectious diseases.
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    \25\  Homeland Security Presidential Directive/HSPD-9-- Defense of 
United States Agriculture and Food; Jan. 30, 2004
---------------------------------------------------------------------------
    (10) Screening/Inspecting Agriculture and Food Items--Validate 
existing screening technology ``mitigation strategies'' and develop 
new/improved technologies.
    (11) National Livestock Readiness Program (NLRP)--Ensure DHS in 
standing up the NLRP to help meet the requirements of the fiscal year 
2017 ``Securing Agriculture and Food Act'' (Public Law 114-328) in 
support of HSPD-9.
    (12) National Biodefense Strategy (NBS)--Confirm that the NBS -- 
Section 1086, fiscal year 2017 National Defense Authorization Act 
(Public Law 114-328) -- includes agriculture (animal health and plant 
health) and that bio/agrodefense components are adequate and 
implemented effectively.
    (13) Biodefense Leadership--Support the Blue Ribbon Study Panel on 
Biodefense's proposal to centralize bio/agrodefense leadership.
                      BIO/AGRODEFENSE BOTTOM LINE
    The bottom line today regarding bio/agrodefense is that ``the clock 
is ticking'' \26\ as stressed by the WMD Commission back in 2009. Much 
must be done to safeguard American agriculture in a globalized world--
the U.S. agriculture and food critical infrastructure is not well 
protected from potentially catastrophic biological events.
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    \26\  The Clock is Ticking: A Progress Report on America's 
Preparedness to Prevent Weapons of Mass Destruction Proliferation and 
Terrorism; Commission on the Prevention of Weapons of Mass Destruction 
Proliferation and Terrorism, October 21, 2009
---------------------------------------------------------------------------
    Bioterrorist attacks on America's food crops and/or food animals 
could devastate the U.S. economy, and the global economy wouldn't be 
far behind. America still feeds the world. Natural disease outbreaks 
could lead to similar outcomes.
    Food shortages in the U.S. may not occur immediately, or ever, 
depending on the effectiveness of the attack or the magnitude of the 
outbreak. Nonetheless, there could still be hugely problematic outcomes 
for America and the world.
    Well-conceived Presidential Directives have not gotten the job 
done; neither did the Patriot Act nor the Homeland Security Act that 
preceded the directives. Key components of American critical 
infrastructure--agriculture and food--are vulnerable to terrorist 
attacks with bioweapons and undeliberate infectious disease outbreaks, 
and the U.S. is unprepared to confront these threats. \27\
---------------------------------------------------------------------------
    \27\  Bodin, Madeline; ``U.S. Remains Unprepared for Agricultural 
Disease Outbreaks,'' Emergency Management, November 13, 2017
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    Congress must act before it's too late.
                                 ______
                                 
    Senator Burr. This hearing is adjourned.
    [Whereupon, at 12:10 p.m., the hearing was adjourned.]

                                   
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