[Senate Hearing 116-259]
[From the U.S. Government Publishing Office]




                                                        S. Hrg. 116-259
 
         BIOLOGICAL THREATS TO UNITED STATES NATIONAL SECURITY

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

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                   EMERGING THREATS AND CAPABILITIES

                                 of the

                      COMMITTEE ON ARMED SERVICES
                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                           NOVEMBER 20, 2019

                               __________

         Printed for the use of the Committee on Armed Services
         
         
         
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               U.S. GOVERNMENT PUBLISHING OFFICE 
41-309 PDF             WASHINGTON : 2020                   


                      COMMITTEE ON ARMED SERVICES

                     JAMES M. INHOFE, Oklahoma, 
                             Chairman
                             
ROGER F. WICKER, Mississippi      JACK REED, Rhode Island
DEB FISCHER, Nebraska             JEANNE SHAHEEN, New Hampshire
TOM COTTON, Arkansas              KIRSTEN E. GILLIBRAND, New York
MIKE ROUNDS, South Dakota         RICHARD BLUMENTHAL, Connecticut
JONI ERNST, Iowa                  MAZIE K. HIRONO, Hawaii
THOM TILLIS, North Carolina       TIM KAINE, Virginia
DAN SULLIVAN, Alaska              ANGUS S. KING, Jr., Maine
DAVID PERDUE, Georgia             MARTIN HEINRICH, New Mexico
KEVIN CRAMER, North Dakota        ELIZABETH WARREN, Massachusetts
MARTHA McSALLY, Arizona           GARY C. PETERS, Michigan
RICK SCOTT, Florida               JOE MANCHIN, West Virginia
MARSHA BLACKBURN, Tennessee       TAMMY DUCKWORTH, Illinois
JOSH HAWLEY, Missouri             DOUG JONES, Alabama
              
                                     
                       John Bonsell, Staff Director
                    Elizabeth L. King, Minority Staff 
                                 Director



           Subcommittee on Emerging Threats and Capabilities

                      JONI ERNST, Iowa, Chairman
                      
DEB FISCHER, Nebraska                GARY C. PETERS, Michigan
KEVIN CRAMER, North Dakota           JEANNE SHAHEEN, New Hampshire
MARSHA BLACKBURN, Tennessee          MARTIN HEINRICH, New Mexico
JOSH HAWLEY, Missouri                MAZIE K. HIRONO, Hawaii
                                 

                                  (ii)

  


                         C O N T E N T S



                           November 20, 2019

                                                                   Page

Biological Threats to United States National Security............     1

Inglesby, Dr. Thomas V., Director, Center for Health Security,        3
  Johns Hopkins Bloomberg School of Public Health.
Dr. Julie L. Gerberding, Co-Chair, Commission on Strengthening       10
  America's Health Security, Center for Strategic and 
  International Studies.
O'Toole, Dr. Tara J., Senior Fellow and Executive Vice President,    16
  In-Q-Tel.

Appendix A.......................................................    35

                                 (iii)


         BIOLOGICAL THREATS TO UNITED STATES NATIONAL SECURITY

                              ----------                              


                      WEDNESDAY, NOVEMBER 20, 2019

                           U.S. Senate,    
                            Subcommittee on
                 Emerging Threats and Capabilities,
                               Committee on Armed Services,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 3:04 p.m. in 
Room SR-222, Russell Senate Office Building, Senator Joni Ernst 
(chairman of the subcommittee) presiding.
    Subcommittee Members present: Senators Ernst, Fischer, 
Hawley, and Peters.

            OPENING STATEMENT OF SENATOR JONI ERNST

    Senator Ernst. Good afternoon, everyone. I want to thank 
you all for joining us today.
    The Emerging Threats and Capabilities Subcommittee meets 
today to receive testimony from Dr. Julie Gerberding, Co-Chair 
of the Center for Strategic and International Studies' (CSIS) 
Commission on Strengthening America's Health Security; Dr. 
Thomas V. Inglesby, Director at the Center for Health Security 
at Johns Hopkins Bloomberg School of Public Health; and Dr. 
Tara J. O'Toole, Senior Fellow and Executive Vice President at 
In-Q-Tel.
    Our focus today will be to gain a deeper understanding of 
the nature and severity of biological threats to our national 
security, as well as the preparedness of the United States to 
defend against and respond to these threats.
    I thank our witnesses for being with us today.
    The 2018 National Biodefense Strategy identified biological 
threats, whether naturally occurring, accidental, or deliberate 
in origin, as among the most serious threats facing the United 
States and the international community and capable of causing 
catastrophic harm to the United States.
    Despite the severity of this threat, I note that a recent 
report by the Center for Strategic and International Studies' 
Commission on Strengthening America's Health Security states 
that the United States remains woefully ill-prepared to respond 
to global health security threats. I find this deeply 
concerning, given the potential devastation of a biological 
event, and look to our witnesses to provide their candid 
assessment of the U.S. posture and programs focused on dealing 
with this challenge.
    Of particular interest is the role of the Department of 
Defense (DOD) in providing sufficient biodefense both abroad 
and at home. DOD has had many biosecurity successes such as 
securing laboratories in allied countries, providing 
surveillance of especially dangerous pathogens, and developing 
lifesaving vaccines for our warfighters. While this 
subcommittee is principally focused on the Department of 
Defense's role in countering the threat, this does not stop at 
a vaccine. It requires constant research, investment, and 
planning across federal, State, and local governments.
    While advancements in biotech research and development have 
provided innovative solutions for treating disease, developing 
alternative fuels, and promoting food security, they have also 
generated new security risks. For example, gene editing 
technology, new targeting methods, and vaccine-resistant 
disease could all be used for nefarious purposes by state and 
non-state actors alike.
    Another particular area of concern for me in my home State 
of Iowa is the potential impact of a biological incident in the 
agricultural sector. A biological attack targeting specific 
types of crops or livestock could be devastating to Iowa 
farmers and have a severely negative impact on the Iowa 
economy. Such an event would not only impact Iowans. Indeed, 
folks across the country would potentially feel the effects of 
food shortages, and the American economy as a whole would 
suffer if our agricultural industry was to be the target of 
such an attack.
    Again, I thank our distinguished witnesses for being with 
us, and I look forward to their testimony.
    I will now turn it over to our ranking member, Senator 
Peters, for his opening statement.

                STATEMENT OF SENATOR GARY PETERS

    Senator Peters. Well, thank you, Chairman Ernst for holding 
this very important hearing here today.
    I want to thank each of our witnesses for taking time to 
come before us and present your thoughts, as well as answer our 
questions.
    There is no question that the threats that we face in the 
area of biosecurity are vast, they are complex and evolving. 
Adversarial nation states still retain the capability to 
produce biological weapons in spite of the Biological Weapons 
Convention. Now even non-state terrorist groups like ISIS 
[Islamic State of Iraq and Syria] can recruit technically 
trained scientists to weaponize pathogens as instruments of 
terror.
    We are in the midst of a technological revolution in gene 
editing with CRISPR [Clustered Regularly Interspaced Short 
Palindromic Repeats], which will give scientists an 
unprecedented ability to modify the genetic code.
    Finally, we must safeguard against threats to our 
agriculture and food supply, such as the African swine fever 
that is spreading at a very rapid pace through Asia and Europe.
    In recent years, Congress has worked to address these 
serious threats. The 2017 National Defense Authorization Act 
required the President to develop a comprehensive biosecurity 
to recognize the spectrum of threats that we face from natural 
occurring outbreak of Ebola to its use by ISIS.
    Published in October of 2018, the Strategy is the first 
acknowledgement of the continuum of threats that we now face. 
Dangerous pathogens know no international borders, and a public 
health biosecurity incident is just as dangerous as an attack 
by a bioweapon.
    More importantly, the Strategy coordinates efforts across 
the Federal Government to better detect and prevent and, if 
necessary, respond to a biothreat.
    While we have made significant progress in the area, we 
still face a number of gaps in our country's biological 
defenses. The bipartisan Commission on Biodefense identified 
numerous recommendations to strengthen those defenses and 
protect our country from the vast array of biological threats.
    The Department of Defense plays a key role in supporting 
the biosecurity strategy, and I look forward to exploring the 
Department's contribution and hearing today about how we can 
improve those efforts.
    Once again, thank you for your testimony here today. I look 
forward to it a great deal.
    Senator Ernst. Now we will go ahead, and we will do our 
witness testimony. Dr. Inglesby, if you would go ahead and 
start. We will have about 5 minutes for your statement. Thank 
you.

   STATEMENT OF DR. THOMAS V. INGLESBY, DIRECTOR, CENTER FOR 
   HEALTH SECURITY, JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC 
                             HEALTH

    Dr. Inglesby. Thank you. chairman Ernst, Ranking Member 
Peters, and members of the committee, thank you for the chance 
to speak with you today.
    My name is Tom Inglesby. I am the Director of the Center 
for Health Security at Johns Hopkins and a professor of public 
health and medicine at Johns Hopkins University.
    The country faces a range of biological threats that could 
emerge without warning, whether from nature, deliberate attack, 
or accident. These threats could include a global pandemic of 
avian influenza, lethal emerging infectious diseases spreading 
from person to person, bioweapons threats like smallpox or 
anthrax, or newly engineered biological threats. Epidemics 
could be caused by accidents from labs working with viruses 
like smallpox or SARS [Severe Acute Respiratory Syndrome] or 
MERS [Middle East Respiratory Syndrome], which are no longer 
circulating in the world, or from research aimed at creating 
novel potential pandemic strains of pathogens. The country also 
faces the potential for deadly large-scale animal outbreaks or 
plant epidemics that kill important crops.
    In major human epidemics, there would likely be an urgent 
need for medicines and vaccines and ventilators, possible 
pressure to close borders, and the potential for hospitals to 
collapse under pressure. There could be serious impact on 
national security and to the Department of Defense with risks 
to health and life in the force and their families, a surge in 
need for medical supplies, big challenges to deployments, 
interruptions to logistics lines, and economic shocks, and 
other disruptions to the country.
    The 2018 National Biodefense Strategy sets national 
priorities for addressing this range of biological threats, and 
this is forward progress. But now the challenge will be 
implementation across the government. I have described a few of 
DOD's important biodefense programs in written testimony. A few 
brief words about them here.
    The Joint Program Executive Office for Chem Bio 
Preparedness works to accelerate the development of new medical 
countermeasures. DARPA's [Defense Advanced Research Projects 
Agency] Bio Technologies Office runs programs seeking 
disruptive change in biotechnology, including new ways to 
manufacture critical molecules and building safety into the 
work of biological science. The Biological Threat Reduction 
program is helping build safe, secure labs in parts of the 
world where new outbreaks could emerge with efforts in 29 
countries. I think all of these programs should be supported.
    Here are my other recommendations to you. The DOD, together 
with HHS [United States Department of Health and Human 
Services] BARDA [Biomedical Advanced Research and Development 
Authority] should substantially increase efforts aimed at 
accelerating vaccine and medicine development for new threats. 
This will require strong programs in government working in 
close partnership with biopharma.
    DOD planning assumptions for pandemics should anticipate 
great disruption to decision-making and operations. The recent 
Clade X and Event 201 exercises showed how pandemics could 
affect national decision-making around travel and trade, the 
use of medical and scientific assets overseas, troop 
deployments, civil liberties around quarantine, and the 
national and international allocation of scarce supplies of 
vaccine.
    The U.S. Government should reestablish a biological threat 
assessment process, which used to be in place. It should 
include not only a focus on bioterrorism, but on state programs 
as well, as well as the possibility of omnicidal or apocalyptic 
groups seeking biological weapons.
    The U.S. Government should plan for the possibility of 
global catastrophic biological risks. These are events that 
could lead to sudden widespread disaster beyond the capability 
of national governments and the private sector to control with 
potential for great loss of life and disruption of governments, 
economies, and global security.
    I would urge you to strongly support the Biological Weapons 
Convention. It is a critical international norm against the 
development and use of biological weapons.
    We should strengthen the U.S. agricultural biodefense 
planning and programs. The USDA [United States Department of 
Agriculture] has made substantial progress in recent years 
around strengthening its programs, but there are priorities 
that should be addressed, including stronger crop surveillance, 
animal wildlife surveillance, more support for animal vaccine 
development, and more funding for agriculture biodefense 
overall.
    We should increase planning with the private sector on 
biothreat initiatives. The private sector is the maker of 
vaccines and medicines and diagnostics. It is also the key 
driver in maintaining travel and trade in major epidemics and 
in supply chain management, communication channels, and many 
more essential missions.
    Finally, we should focus on strengthening the U.S. 
bioeconomy, which underlies a lot of this. That includes 
medicines and vaccines, food production, energy production, and 
industrial processes. The success of the bioeconomy is 
important to national security just as in the way that U.S. 
manufacturing in Silicon Valley have been to U.S. national 
security as well.
    In conclusion, there are a range of serious biological 
threats facing the country. It is critical that DOD continue to 
invest in and prepare for biological threats, particularly high 
consequence threats, even catastrophic ones, that could have 
major national security implications.
    Thank you.
    [The prepared statement of Dr. Inglesby follows:]

                 Prepared Statement by Tom Inglesby, MD
    Chairman Ernst, Ranking Member Peters, and members of the 
Committee, thank you for the chance to speak with you today about 
Biological Threats to U.S. National Security.
    My name is Tom Inglesby. I am the Director of the Center for Health 
Security of the Johns Hopkins Bloomberg School of Public Health and a 
Professor of Public Health and jointly in Medicine at Johns Hopkins 
University. 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 major 
epidemics and disasters and build resilience. We study the 
organizations, systems, and tools needed to prepare and respond.
    I will provide comments on biological threats facing the country, 
major drivers of those threats, and key Department of Defense programs 
which are aimed at preparing for and responding to them. My testimony 
will also provide strategic recommendations about how the DOD, in 
concert with other departments and agencies should be considering and 
acting to prevent and prepare to respond to these threats.
Biological Threats to the United States
    The country faces a range of biological threats that can emerge 
without warning from nature, deliberate attack, or accidental release. 
We have had major influenza pandemics in the past and there is 
scientific agreement we will again experience a pandemic of influenza 
that sweeps the world, including the U.S. There will likely also be the 
emergence of new infectious diseases spread by respiratory route from 
person to person, such as the SARS or MERS viruses which emerged as 
surprises and had case fatality rates of 10 percent and 30 percent, 
respectively.
    In terms of deliberate threats, we continue to face the prospect of 
biological weapons attacks, both from known very high consequence 
pathogens, such as the agents that cause anthrax and smallpox, as well 
as from unknown novel and engineered biological threats. Epidemics 
could also emanate from pathogens that are released from research labs 
accidentally, including from laboratories working on non-circulating 
viruses such as SARS or smallpox, or from research work that has 
created novel epidemic strains of pathogens. We have seen biosafety 
breaches in our own DOD and CDC labs in the past, and accidents in 
other labs internationally. In the realm of animals and plants, we 
could also face high consequence natural, deliberate or accidental 
biological threats that could cause deadly large-scale animal 
outbreaks--epizootics--or the killing off of important crops. These 
kinds of natural, deliberate and accidental biological threats could 
pose serious challenges to U.S. national security.
    The global and United States experience with Ebola in West Africa 
in 2014-2015, and then again in DRC in this last year, has given us a 
snapshot of what major epidemics can do. Ebola in West Africa sickened 
more than 28,000 and killed more than 11,000. Countries from around the 
region and different parts of the world stopped allowing travel to 
affected countries. National economies were badly damaged, and doctors 
and nurses were killed in high numbers. People lost confidence in 
government and police forces were used to create quarantines, which did 
not work. The epidemic there was only brought under control after 
enormous international collaboration with governments in the region and 
many billions of dollars spent.
    In the U.S., we saw that only a few returning people with Ebola 
caused extraordinary public anxiety. Only a few cases generated intense 
national concern, leading to major response efforts by the 
Administration, as well as the attention of Congress and multiple 
governors and state governments. While this Ebola experience in the 
U.S. did not in and of itself pose national security consequences, it 
is easy to extrapolate the enormous security and economic impact if 
there were hundreds or thousands of cases of Ebola in the U.S. started 
via deliberate attack. Or, imagine if the disease at hand were easy to 
spread from person to person in the U.S. (Ebola does not spready 
easily). There could be pressure to close borders, the potential for 
hospitals to collapse under pressure, scarcity of medicines or 
ventilators, impact on troop deployments, concern about safety of U.S. 
personal overseas and much more.
    We are now a year into an Ebola outbreak in DRC where approximately 
2,000 people have been killed so far. No cases of Ebola have come to 
the U.S. in this outbreak, and there are some hopeful signs that this 
DRC epidemic could be contained. But an important lesson is that 
diseases like Ebola can take hold in countries with poor public health 
infrastructure, and from these countries could have the capacity to 
spread regionally and beyond. This outbreak has teetered right on the 
edge of being out of control in this past year. If Ebola spread broadly 
outside of DRC, quite serious international security consequences would 
follow for the U.S. and its partners, affecting travel, trade and 
security, and making it hard to operate safely in important regions of 
the world.
Drivers of the Biological Threat
    There are a number of trends that make naturally emerging epidemics 
and pandemics more likely. Many of the emerging diseases that affect 
people have jumped from animals, and people in large numbers are living 
close to animals and encroaching on previously wild ecosystems. More 
and more people live in megacities where public health and health care 
is not strong, and where disease can move quickly. Once a disease gets 
started, it can move around the world by plane in 24 hrs. The climate 
is changing--animals are moving into new places, vectors like 
mosquitoes have broader range, and pathogens will have new, more 
conducive climates to thrive. And there is growing global resistance to 
antimicrobials that we have relied upon.
    In the realm of deliberate threats, there is continued global 
dispersion of biotechnology, which is a powerful force for economic 
growth. Genome sequencing and synthesis get continually faster and 
cheaper. In 2013, there had been several thousand human genomes 
sequenced; in 2019, there are now well over 1 million. Every government 
with any life science capability can now sequence and synthesize 
whatever it would like to. Genomes can be engineered to give them new, 
potentially dangerous characteristics, transforming pathogens that are 
now benign into pathogens that have the ability to spread or the 
ability to be lethal.
    In addition to engineered pathogens themselves being a serious 
concern, a related concern is the availability of the information 
needed to make them publicly online. If potential novel pandemic 
pathogen strains are created and the process for creating them is put 
on-line, the recipes for the creation of those novel pandemic pathogens 
will be permanently retrievable by anyone with access to the web. This 
category of problem has been called ``information hazard.''
    A key problem with biosecurity against new biological threats as it 
exists now is that new threats can emerge or be developed far more 
quickly that defenses against those threats can be made. Continuing to 
push forward with the ability to rapidly make countermeasures against 
novel threats will be pivotal. Two high-profile assassinations in 
Malaysia and the United Kingdom using chemical weapons have underscored 
the importance of ensuring capability to respond to weapons and tactics 
that use unconventional weapons.
United States preparedness and response programs
    The 2018 National Biodefense strategy is the first U.S. biodefense 
strategy that takes on natural, deliberate and accidental biological 
threats. The strategy addresses nation-state and terrorist threats, and 
both international and domestic biological threats. It also includes a 
focus on human, animal and plant biological threats in one overall 
approach. This approach to addressing the full spectrum of biological 
threats is a potential strength and a way to enumerate all priorities 
in one place. The potential downside of a strategy with his breadth is 
that it will be challenging to assess where we stand with respect to 
all priorities articulated, and to measure progress over time for 
activities that span across government. It will be important to make 
sure agencies and offices understand their responsibilities, timelines 
and budgets for addressing the priorities in the strategy.
Valuable DOD efforts around Biosecurity
    At a high level, it is noteworthy that the U.S. National Defense 
Strategy cites biotechnology as one of the top new technologies that 
affects the U.S. national security environment. That strategy document 
also identifies defense against biological weapons as a continued 
priority, and recognizes that bioengineering is ``increasing the 
potential, variety, and ease of access to biological weapons.'' Despite 
preparedness for biological threats being a priority in that strategy, 
our own Center's analysis shows the funding for DOD biodefense programs 
has steadily been decreasing over the last 5 years. What follows are a 
few valuable DOD biosecurity related programs that are worth 
specifically calling out.
    Joint Program Executive Office Chem Bio defense program (JPEO CB)
    The mission of this program is to ``manage the nation's investments 
in chemical and biological equipment,'' including medical 
countermeasures. There is good, new potential within this program. They 
have capabilities to characterize new biological threats, and they are 
working to create capabilities to develop countermeasures for new 
threats. They work closely with the development and surge manufacturing 
company Ology, and they have established clinical trials networks 
overseas to get new medicines into the field quickly. About 90 percent 
of the time they are working on day to day research and development for 
medical countermeasures to biological threats that are already known 
(e.g. plague), but 10 percent of the effort is dedicated to creating 
and testing capabilities (i.e. working with major cell lines for the 
range of known medicines and vaccines) that would be needed to deal 
with surprises or unknowns. The JPEO-CB program is establishing a new 
way of trying to accelerate MCM development for DOD, so it is too soon 
to know whether it will succeed as planned. But the combinations of 
science, technology, clinical trials, and manufacturing seems to have 
promise and worth supporting. The budget for this program has been cut 
in half over the last 5 years, and that seems like a mistake to me. At 
a higher DOD level, JPEO is the implementer for the DOD-wide Chemical 
and Biological Defense Program (CBD) for the Assistant Secretary for 
Defense NCB. The presidential budget for the CBD program in fiscal year 
2020 was $300 million for biodefense-related programs, while the budget 
for this program in fiscal year 2014 was almost twice that at $560 
million. We haven't reduced the number of biological threats facing the 
force (or the country) since that time. So it is illogical that the 
program has been cut nearly in half.
    DARPA Biological Technologies Office (BTO)
    The mission of BTO is to ``foster, demonstrate, and transition 
breakthrough fundamental research, discoveries, and applications that 
integrate biology, engineering, computer science, mathematics, and the 
physical sciences.'' BTO has about 10 programs with talented program 
managers from a range of scientific disciplines. They run programs on 
in issues including: engineering to develop new functional systems and 
products; developing new platform technologies for miniaturizing 
biological samples; creating systems that help support operations in 
extreme environments; protecting against emerging threats to food, 
water and agriculture; and, developing new systems to prevent and 
respond to infectious diseases. They are seeking big disruptive 
changes. For example, I have been particularly impressed with the 
Living Foundries program which ``aims to enable . . . on-demand 
production of molecules by programming the fundamental metabolic 
processes of biological systems to generate a vast number of complex 
molecules that are not otherwise accessible.'' This program's success 
has led to the DOD intention to establish a new Manufacturing 
Innovation Institute dedicated to Synthetic Biology which, while not 
associated with U.S. Biodefense, will seek to use synthetic biology to 
manufacture new products more cleanly, more sustainably and/or cheaply 
that current industrial processes. Equally impressive is the Safe Genes 
program which works to prevent ``accidental or intentional misuse of 
genome editing technologies'' by building in intrinsic biosafety 
systems within the science itself. I think the approach to biosafety in 
this program should really be a model for other BTO work and for USG 
funded work around bioengineering of pathogens. BTO overall has an 
approach to life sciences research and development that is unique in 
the government and really should be supported. The proposed 2020 
Administration BTO budget for this was \1/3\rd of its budget from the 
year before and that kind of cut would be a mistake.
    Biological Threat Reduction Program (BTRP) of the Cooperative 
        Threat Reduction Program (CTR) in the Defense Threat Reduction 
        Agency (DTRA)
    The mission of BTRP is ``enhance disease detection, diagnosis, 
surveillance, and reporting capabilities; develop human resource 
expertise in public and animal health; promote safe and secure 
laboratory working environments; and consolidate pathogens of security 
concern into a minimal number of safe and secure facilities in a 
sustainable manner.'' (cf program website) For example, they have 
helped to build labs in Uganda and in Liberia where early warning on 
disease outbreaks can help mobilize response more quickly. Their labs 
have helped in the Ebola response in the West Africa Ebola response. 
They provide biosafety and biosecurity programs around the world, 
including recently in North Africa where there is concern about violent 
extremist organizations. Through efforts of the BTRP program, national 
experts from Algeria, Egypt, Libya and Tunisia were trained and 
returned home better skilled to teach biosafety and biosecurity around 
their countries. They are doing this work in 29 countries and have 
developed strong working partnerships in these places.
    strategic recommendations with relevance to dod and broader usg
Support key USG programs to accelerate MCM development process
    In addition to the DOD programs aimed at R&D for MCM development, 
there are key MCM related efforts at NIH, BARDA, FDA and CDC. For 
example, BARDA has developed 52 licensed products for biodefense, runs 
the Bioshield program for MCM procurement, and has a large pandemic flu 
effort. But it has not been funded to develop a strong program on new 
vaccines for Emerging Infectious Diseases and unknown novel threats. 
BARDA has done advanced development work on Ebola and Zika in crises, 
but then when the crisis passes it does not have the funding to create 
a full-scale organization dedicated to rapidly creating MCMs for novel 
biological threats that could emerge from nature or deliberate weapons 
use. I think these efforts to build capabilities for EIDs and unknown 
threats (in addition to the JPEO CB efforts around development and 
manufacturing) should be strongly supported with new funding.
    A recent bio-exercise our Center held, Clade X, shed light on how 
crucial medical countermeasures would be in the event of a severe 
pandemic, and how current timelines for production are too slow to be 
meaningful. Clade X also showed how biological crises could affect 
national decision making around travel and trade, the use of medical 
and scientific assets overseas in a crisis, troop deployments, civil 
liberties around quarantine, and the national allocation of scarce 
supplies of vaccine.
    Given how crucial the availability of MCMs will be to any 
biological crisis in the future, we need to keep pushing these programs 
and technologies forward, trying different models, different 
technologies, and explore new arrangements with industry. There should 
be substantial investment into platform technologies and broad-spectrum 
antivirals. There should be a major program in the USG (BARDA and DOD) 
focused on developing MCMs for unknown or novel threats. It's also 
critical for the USG to work more effectively with the biopharma 
industry to make products we will need in a crisis. The USG cannot make 
products effectively without industry, but it has been a sometimes 
fickle partner that encourages industry to do substantial amounts of 
work but then has sometimes dropped the ball quickly when a crisis 
starts to resolve.
Approach risk assessment strategically and safely
    The process of risk assessment involves understanding science, 
intelligence, vulnerability. It also needs to incorporate the 
possibility of surprise, and the chance that the USG may receive no 
intelligence or scientific warning regarding new biological threats. 
DHS used to have a biological threat assessment process that was one 
practical tool for trying to understand the range of biological threats 
facing the nation. DHS stopped preparing its biological threat 
assessment in the last couple years for unclear reasons, and now there 
is no overall USG risk assessment process for biological threats. A 
process should be re-established for prioritizing biological risks in 
the USG.
    Biological risk assessment in the years since 9/11 has been focused 
predominantly on terrorism risks. Inclusion of bioterrorism has its 
logic given that biological expertise is widely distributed in the 
world, and small groups of talented people could do great damage with 
biology if they had training, time and resources. However, there has 
been insufficient attention in risk assessment efforts concerning 
threats posed by other countries. State actor programs should be 
specifically included in bio risk assessment. The USG bio risk 
assessment in the past also did not take into account the potential for 
omnicidal terrorist groups, movements or cults that have apocalyptic, 
population reduction, or other catastrophic goals. That should change 
now.
    While establishing a rigorous bio risk assessment is valuable and 
necessary, it is very important that it does not prompt the creation or 
lab or field testing of novel pathogen strains with epidemic or 
pandemic potential. Neither the USG nor other governments should be 
creating highly dangerous new strains of epidemic pathogens for the 
purpose of demonstrating that such strains could be created by our 
adversaries. Not only could such strains inadvertently escape a 
laboratory, they could also be deliberately removed from a lab and used 
to do great harm. Science now has the potential to create strains of 
pathogens that could self-propagate in society beyond our ability to 
respond to them and initiate new epidemics. The USG should not support 
work in this realm unless there is an extraordinary justification, with 
very high benefits that would warrant the risks and which could be 
achieved in no other way.
Risk assessment should include a focus on the possibility of 
        catastrophic biological risks
    The USG risk assessment process for biological threats should 
include within its scope the possibility of global catastrophic 
biological risks. These would be events, whether naturally emerging or 
reemerging, deliberately created and released, or laboratory engineered 
and escape, that could lead to sudden, extraordinary, widespread 
disaster beyond the capability of national and international 
governments and the private sector to control. If unchecked, these 
kinds of events could lead to not only loss of life but also sustained 
damage to the USG, other governments, economies, societal stability, or 
global security. Examples of this kind of event could include smallpox 
for many parts of the world (though less so for the U.S. that now has 
vaccine); a novel highly transmissible H5N1 bird flu that could infect 
humans with its current case fatality rate of 50 percent; and 
bioengineered viruses that threaten either the food supply broadly, or 
that target specific populations. Even if USG decision makers deem the 
probability of these threats taking place to be low, the consequences 
of them should they occur are enormous enough to warrant specific 
attention from USG policy and programs, including the above mentioned 
programs for rapidly responding to unknown threats with MCM 
development, scale up and surge manufacturing.
Support the BWC and ways to increase international assurance
    National security decision makers in the USG--the NSC DOD, DOS, 
Congress, etc.--should strongly support bio non-proliferation efforts, 
particularly those related to the strengthening of the Biological 
Weapons Convention (BWC). The BWC has established a very important norm 
in the world against the development and use of biological weapons. 
While various public assessments have concluded that some countries 
secretly pursue biological weapons, no country openly admits to 
creating or developing biological weapons. Because there is a strong 
taboo against them, there is no open biological arms race. The USG 
should continue to do what it can to bolster that deeply valuable norm, 
and to build mechanisms between countries that can offer assurance that 
countries are not pursuing biological weapons programs.
Strengthen US Agricultural biodefense
    In recent years, I have been very happy to see an increase in 
attention by USDA to Agricultural biological threats, whether they come 
from natural or deliberate cause. There are many important elements of 
U.S. Agrodefense including the coming opening of NBAF for research, and 
the intramural research that ARS and extramural work that NIFA support 
on these issues. The USDA has a number of surveillance systems in 
place, and it has a laboratory network for diagnosing animal diseases 
and plant diseases. There is a National Veterinary Stockpile for 
countermeasures to serious animal diseases. There are USDA offices in 
every county in the country. And USDA was a key partner in the 
development of the National Biodefense Strategy.
    Despite many positive elements of Ag defense and recent positive 
trends, there are things that need to be strengthened. There should be 
some kind of overall risk assessment process for Agricultural 
biological threats, or at least one by class of animal and plant. The 
Agricultural Research and Development Authority (AGARDA) was authorized 
in 2018 for up to $50M but is not yet funded. Plant surveillance for 
the most serious diseases is weak compared to livestock animal 
surveillance efforts. Wildlife surveillance for emergence of new 
diseases, too, should be strengthened. The Veterinary Stockpile budget 
is small about 100 times smaller than the human SNS. And overall the 
budget for USDA programs on Ag defense is not enough for the programs 
that are needed.
Recognize the role of the private sector in preparing for, responding 
        to biological threats
    The country relies on the private sector to make the vaccines, 
medicines, diagnostics and medical equipment etc that we need to 
respond. It is less well recognized that the private sector will also 
be responsible for making travel and trade systems continue to function 
in a pandemic. The private sector will need to keep supply chains open, 
run communication channels for the public and carry out many other 
critical functions. Together with the Bill and Melinda Gates foundation 
and the World Economic Forum, our Center ran an international pandemic 
exercise in NY last month called EVENT 201. This exercise showed how 
dependent national governments and international organizations would be 
on many domains of the private sector in a pandemic crisis. We would 
need systems to keep planes flying and ships moving despite infectious 
disease risks. International partnerships with the private sector would 
be needed to make decisions about distribution and allocation of 
vaccines--if they are made in country X, will other countries in the 
world be able to access them? Should there be central stockpiles at the 
World Health Organization for new pandemic diseases? And the private 
sector will be central to financial response in a pandemic--not just 
funding for the direct public health and medical response to a 
pandemic, but how to keep finance systems functioning, make sure there 
are not banks or companies too big to fail in ways that could start to 
unravel international finance systems.
Promote and Ensure the U.S. Bioeconomy
    An important part of the U.S. economy is built on biotechnology, 
including in the realms of new medicine and vaccine development, food 
production, energy, and industrial processes. The success of the U.S. 
Bioeconomy is important to national security. Other governments have 
recognized the tremendous potential value of the bioeconomy and are 
making investments in U.S. companies, and the U.S. needs to have a 
strategy to grow and retain its biotech industries and workforce. The 
U.S. Government should move toward contracting mechanisms that 
recognize many of the in-kind benefits of biotechnology. Fuels, 
specialty chemicals, and other products made using biological processes 
may be expensive in comparison to products made through more 
traditional approaches, but the higher cost does not include the 
potential benefits of biologically processed products, including 
sustainability, reduced logistics costs if the biologically produced 
products can be produced closer to where they are needed, opportunities 
to alleviate supply chain constraints or avoid disruptions, and 
avoidance of environmental contamination and damage.
    The USG should also identify ways to recruit and retain talent 
needed to run innovative biotechnology R&D programs. It should initiate 
the tracking of data around the biotech workforce and company formation 
as these data compared to other countries. Data on the U.S. brain drain 
in science and technology is available from the academic perspective 
through the National Science Foundation, but there is limited data from 
the industry perspective. The USG should consider strategic use of non-
dilutive capital, matched by VC investments, to help drive the creation 
of key biotech companies that would be important to the U.S. 
bioeconomy. If the U.S. Government were more explicit about what kinds 
of biotechnology-derived products it may need, the biotechnology 
industry could be more valuable to the government. There are direct 
applications of synthetic biology beyond medical countermeasures that 
offer value to the U.S. economy and defense. Products such as 
biologically made concrete, cloth, caffeine production, food, and rare 
earth mining are just a few biotechnologies that may be valuable to the 
government or to defense. In addition, there are medical benefits, 
including regenerative manufacturing of organs or human tissue, that 
may benefit injured warfighters.
Conclusion
    In summary, there are a range of natural, deliberate and accidental 
high consequence biological threats facing the country. The Dept of 
Defense has responsibilities, programs, science and assets that are 
critical in efforts to prevent, detect and respond to those biological 
threats. The DOD's efforts are part of a larger USG national biodefense 
strategy and set of programs that are key to preparing the country for 
major biological events. It is critical that DOD continue to invest in 
and prepare for biological threats, particularly for high consequence, 
even catastrophic biological events, that could have national security 
implications, either through direct serious health and life risks to 
troops, challenges to deployments, interruptions to logistics, illness 
in family members, major damage to the economy, or other major shocks 
and disruptions to the country.

    Senator Ernst. Thank you, Dr. Inglesby.
    Dr. Gerberding, please.

 STATEMENT OF DR. JULIE L. GERBERDING, CO-CHAIR, COMMISSION ON 
 STRENGTHENING AMERICA'S HEALTH SECURITY, CENTER FOR STRATEGIC 
                   AND INTERNATIONAL STUDIES

    Dr. Gerberding. Good afternoon and thank you. Chairwoman 
Ernst, Ranking Member Peters, and all of the staff of the 
subcommittee, thank you for paying attention to this really 
important national issue.
    I am pleased to discuss with the subcommittee the 
recommendations of a report from the Center for Strategic and 
International Studies Commission on Strengthening America's 
Health Security. The full report was released today, and it is 
entitled ``Ending the Cycle of Crisis and Complacency.''
    I co-chair this commission with former Senator Kelly 
Ayotte. Members of Congress who serve as commissioners include 
Senators Murray and Young and Representatives Bera, Brooks, 
Cole, and Eshoo. We also are served by several biosecurity 
experts from around the country, and their commission work is 
still ongoing.
    We began our work with an indisputable premise, and that is 
that biological threats, whether from natural, intentional, or 
accidental causes, are occurring more often and have the 
potential to cause unprecedented harm to Americans and to 
people around the world.
    The world we live in now is amazingly insecure, violent, 
and disordered, and it is exactly in these circumstances that 
these biologic threats emerge and spread. All we have to do is 
look at the DRC [Democratic Republic of the Congo] situation 
with Ebola to understand the complexity and the opportunity for 
emergence.
    Not only is our disordered world more conducive to the 
emergence of biothreats, but we are also, of course, 
increasingly connected and interdependent. Globalization, 
international trade and travel all mean that an outbreak in one 
part of the world can very quickly be a threat to us here in 
the United States. In other words, a threat anywhere is a 
threat everywhere.
    In that context, health security threats truly are national 
security threats, and that brings them right into the domain of 
the subcommittee.
    Unfortunately, despite the fact that policymakers know to 
invest in threats when they emerge, all too often the 
recognition occurs only after a health crisis strikes. I 
certainly experienced exactly that in my government tenure with 
the anthrax, SARS, West Nile, avian influenza outbreaks. My 
successors at CDC [Centers for Disease Control and Prevention] 
have experienced the same thing with an influenza pandemic, 
MERS, Ebola, Zika, and so forth.
    When biothreats are recognized, policymakers do allocate 
emergency resources, but critical time, sometimes weeks to 
months, passes before these resources are available, and in 
that time, lives are lost.
    Once the crisis fades and public attention subsides, 
urgency morphs into complacency, investments dry up, attentions 
shift, and a false sense of security takes hold.
    The commission asserts that the U.S. Government has to end 
this cycle of crisis and then complacency. We need to replace 
it with a doctrine that can guarantee continuous prevention, 
protection, and resilience.
    In that spirit, we commend the release of the National 
Biodefense Strategy last fall and the Global Health Security 
Strategy this year. These do provide a solid foundation, but we 
need action.
    What the commission has presented in its report today is an 
agenda for specific actions that the Congress might undertake 
to try and strengthen our ability to be prepared and respond to 
health security threats.
    I do not have time to go into all of these. They are 
outlined in the summary report. But we do have a couple that we 
wanted to highlight because we think they would be especially 
germane to the subcommittee.
    First and foremost, we think it is important that we 
clarify what leadership at the National Security Council is 
accountable for the overall government engagement in health 
security threats. Right now, it is unclear who would be in 
charge. Strong, coherent leadership at the National Security 
Council is essential to guaranteeing effective oversight long 
before crises emerge.
    We also recommend actions to augment the important role 
that the Department of Defense plays in health security. One 
important area is DTRA [Defense Threat Reduction Agency], and 
we believe that DTRA should have extended authority to operate 
in all continents where health security threats exist.
    Furthermore, the support for the military's infectious 
disease research laboratories should be strengthened. During my 
tenure, I had the opportunity I think to visit all of the Navy 
and Army laboratories around the world, and I saw firsthand how 
critical they were in the front line of influenza preparedness, 
but also the broad investment in developing and researching 
other infections diseases that are not necessarily studied by 
other agencies or for which countermeasures would not be 
developed at all. I think these laboratories are a national 
treasure, a critical front line of our global surveillance and 
response, and we must continue to support them.
    The last point I would like to comment on is the importance 
of our ability to rapidly respond to emerging threats and 
mitigate harm to affected people. The contingency fund levels 
for CDC and USAID [United States Agency for International 
Development] should be increased and sustained. In addition, we 
should establish a U.S. global health crisis response corps, 
which is based on existing CDC and USAID capabilities, but to 
have this team with the trained and exercised ability to 
deployed and work with local partners in health crisis 
settings, even when those settings are insecure.
    In summary, the commission urges Congress to invest in 
biothreat reduction as the national security imperative. We 
believe the long-term costs of strategic protection and 
prevention are but a tiny fraction of the astronomic costs of 
episodic and too often chaotic responses to emerging crises. 
These smart investments would draw support from all.
    Thank you for the opportunity to testify. It is really my 
hope that we can end this cycle of crisis and complacency, and 
I request that the CSIS report on Ending the Cycle of Crisis 
and Complacency be submitted for the record. Thank you.
    Senator Ernst. Without objection.
    [The CSIS report on Ending the Cycle of Crisis and 
Complacency can be found in Appendix A.]
    [The prepared statement of Dr. Gerberding follows:]

             Prepared Statement by Dr. Julie L. Gerberding
    Chairwoman Ernst, Ranking Member Peters, and other distinguished 
Members of the Subcommittee--I am truly grateful for the opportunity to 
appear before you today. The topic of biological threats to U.S. 
national security remains vitally important and is deserving of far 
greater consideration. Thank you for your leadership in this critical 
area.
    The timing of today's hearing is especially propitious, since it 
falls on the very day that we are releasing the full report of the 
Center for Strategic International Studies (CSIS) Commission on 
Strengthening America's Health Security, entitled Ending the Cycle of 
Crisis and Complacency.
    I co-chair that Commission with former Senator Kelly Ayotte. CSIS 
launched the Commission in April 2017. It includes among its very 
active members Senators Patty Murray (D-WA) and Todd Young (R-IN), 
Representatives Ami Bera (D-CA), Susan Brooks (R-IN), Tom Cole (R-OK), 
and Anna Eshoo (D-CA), along with 12 other diverse leaders, including 
from the security world General Carter Ham, Admiral Jonathan Greenert, 
Christine Wormuth, and Rebecca Hersman.
    We will make available the full Commission report for the 
Subcommittee.
    Given the Subcommittee's agenda, please allow me to lay out 
succinctly the central premises that guide our work, along with a 
summation of the Commission's recommendations. My hope is that we can 
identify today several points of common purpose in the Commission's 
work and the Subcommittee's priorities.
    We began the Commission's work with a simple, powerful proposition: 
health security is national security, in a world that is increasingly 
dangerous and interdependent.
    Biological threats--outbreaks from natural, intentional and 
accidental causes--are occurring with ever higher velocity, rapidity 
and costs. \1\ At the same time, the world is increasingly insecure, 
violent and disordered, and it is exactly in danger zones where an 
increasing number of biological outbreaks occur. \2\
---------------------------------------------------------------------------
    \1\ Katherine F. Smith et al., ``Global rise in human infectious 
disease outbreaks,'' Journal of the Royal Society Interface 11 
(December 2014), https://royalsocietypublishing.org/doi/full/10.1098/
rsif.2014.0950.
    \2\ Rebecca K. C. Hersman, Meeting Security Challenges in a 
Disordered World (Washington, DC: CSIS, May 2017), https://csis-
prod.s3.amazonaws.com/s3fs-public/publication/170522 
_Hersman_MeetingSecurityChallenges_Web.pdf?UKD0LRcihyrV02wgy9AQIQHGzhMId
Acb.
---------------------------------------------------------------------------
    We need to adjust our thinking to account for this fundamental new 
reality. We need new approaches to operate effectively, on-the-ground, 
in difficult, insecure places.
    Increasing levels of disorder and conflict around the world are 
resulting in the costly destruction of public health and clinical 
infrastructure. Population growth, urbanization, and the mass movement 
of populations are forcing more people into overcrowded and unsanitary 
living conditions, creating ideal conditions for the emergence and 
spread of infectious diseases. Globalization and the rise of 
international trade and travel mean that an outbreak in a disordered 
setting with a weak health system can quickly become a pandemic, 
threatening the United States and the rest of the world. Policymakers 
increasingly appreciate these threats can undermine the social, 
economic, and political security of nations.
    The Commission also arrived at a stark, companion conclusion: U.S. 
health security policy is caught in a cycle of crisis and complacency, 
which leaves Americans very vulnerable.
    When health crises strike--measles, MERS, Zika, dengue, Ebola, 
pandemic flu--the American people grow alarmed and U.S. policymakers 
spring into action, rushing to allocate resources in response. Yet all 
too often, when the crisis fades and public attention subsides, urgency 
morphs into complacency. Investments dry up, attention shifts, and a 
false sense of security takes hold.
    That realization led us to our macro-conclusion: first and 
foremost, the U.S. Government needs to break the cycle of crisis and 
complacency and replace it with a doctrine that can guarantee 
continuous prevention, protection, and resilience.
    We are convinced that we can break this cycle. Health security and 
biodefense are areas that historically enjoy strong bipartisan support 
in Congress, healthy and fruitful cooperation between Congress and the 
Administration, and strong, promising public-private partnerships.
    Health security, luckily, is an oasis of sorts. In an era of acute 
political polarization, it is a policy zone where, across the political 
divide, we recognize our shared interests and can have informed 
discussions to chart a common path forward. We recognize that health 
security challenges are innately complex, and require all of us working 
together, across jurisdictions, agencies, and sectors, to create a much 
better line of defense. We should celebrate this good fortune and take 
full advantage of it.
    The Commission also believes that the economic case to invest early 
in preparedness and biodefense is crystal clear--and powerful. There is 
much accumulated evidence from recent outbreaks proving the 
affordability of investing in preparedness, and the huge costs of not 
investing. The United States faces a choice: it must either pay now and 
gain protection and security, or wait for the next crisis and pay a 
much greater price in human and economic costs.
    The long-term costs of strategic protection and prevention programs 
are but a tiny fraction of the astronomic costs of responding to 
sudden, emergent crises. The 2014-2016 West Africa Ebola outbreak is 
illustrative. Beyond the devastating loss of human lives, the outbreak 
had enormous social and economic costs, with global repercussions. The 
U.S. Government spent nearly $2.4 billion in emergency funding to 
support the international Ebola response. \3\ The outbreak ultimately 
cost the global economy more than $53 billion, an average of more than 
$1.8 million per Ebola case. \4\ The cost of basic preparedness in low 
income countries is roughly $1 per person per year. \5\
---------------------------------------------------------------------------
    \3\ ``West Africa--Ebola Outbreak, Fact Sheet #6, FY 2016,'' USAID, 
January 21, 2016, https://www.usaid.gov/sites/default/files/documents/
1866/west _africa _fs07 _01-21-2016.pdf.
    \4\ Caroline Huber, Lyn Finelli, and Warren Stevens, ``The Economic 
and Social Burden of the 2014 Ebola Outbreak in West Africa,'' The 
Journal of Infectious Diseases 218, suppl. no. 5 (December 15, 2018): 
S698-S704, https://doi.org/10.1093/infdis/jiy213.
    \5\ The International Working Group on Financing Preparedness (IWG) 
estimates $0.50-$1 per person per year would be needed, although there 
is variation in cost estimates by country. The range of $0.50-$1.50 
captures most reasonable estimates. See: International Working Group on 
Financing Preparedness, From Panic and Neglect to Investing in Health 
Security.
---------------------------------------------------------------------------
    The Commission commends the recent advances in U.S. health security 
and biodefense policy, including the release of the National Biodefense 
Strategy last fall and the Global Health Security Strategy this year. 
\6\\7\ These are positive steps forward, which we should build upon.
---------------------------------------------------------------------------
    \6\ White House, National Biodefense Strategy (Washington, DC: 
September 2018), https://www.whitehouse.gov/wp-content/uploads/2018/09/
National-Biodefense-Strategy.pdf.
    \7\ White House, United States Government Global Health Security 
Strategy (Washington, DC: 2019), https://www.whitehouse.gov/wp-content/
uploads/2019/05/GHSS.pdf.
---------------------------------------------------------------------------
    What is urgently needed, in our opinion, is concrete, concerted 
action by Congress and the Administration.
    The CSIS Commission on Strengthening America's Health Security 
advocates for a package of strategic, affordable actions to advance 
U.S. health security. In combination, these actions constitute a 
doctrine that can guarantee continuous prevention, protection, and 
resilience.
    First and foremost, we recommend that health security leadership at 
the White House National Security Council (NSC) be restored.
    Today, it remains unclear who would be in charge at the White House 
in the event of a grave pandemic or cross-border biological crisis, 
whether natural, accidental, or deliberate. The lack of clarity is 
dangerous and should be rectified. Furthermore, strong, coherent 
leadership at the NSC is essential to guarantee effective oversight of 
global health security and biodefense policy and spending. With that 
leadership in place, it becomes possible to achieve higher efficiencies 
in the use of scarce resources, overcome fragmentation and redundancy 
of programs, and ensure greater rigor and accountability.
    We advocate for the right mix of quality investments of resources.
    We need to invest directly and consistently over the next decade in 
the capacities of low-income countries. Such a long-term, predictable 
approach is essential, if basic preparedness is to be created.
    The best approach to protect the American people is to stop 
outbreaks at the source. The Global Health Security Agenda, or GHSA, 
established in 2014, is designed to do just that. \8\ GHSA has a proven 
track record in building health systems and health security 
preparedness in low- and middle-income countries, financed through a $1 
billion Ebola emergency supplemental funding. \9\ We should sustain 
that record of success, not disrupt or curtail it.
---------------------------------------------------------------------------
    \8\ The GHSA is coordinated by a multilateral steering group 
comprised of 10 countries, including the United States, and is advised 
by several international organizations including the WHO, Food and 
Agriculture Organization (FAO), the World Organization for Animal 
Health (OIE), the World Bank, and Interpol. See: ``Membership,'' Global 
Health Security Agenda, updated March 26, 2019, https://
www.ghsagenda.org/members.
    \9\ ``Implementing the Global Health Security Agenda: 2017 Progress 
and Impact from U.S. Investment,'' GHSA, February 2018, https://
www.ghsagenda.org/docs/default-source/default-document-library/global-
health-security-agenda-2017-progress-and-impact-from-u-s-
investments.pdf ?sfvrsn=4.
---------------------------------------------------------------------------
    The DOD contributes to this and other U.S. health security efforts 
through a number of programs that are aimed at countering biological 
threats from all sources. \10\ The DOD operates a worldwide public 
health, infectious disease research, and disease surveillance network 
to protect U.S. and allied forces against infectious diseases and other 
biological hazards. Critical programs include the DOD Defense Threat 
Reduction Agency's (DTRA) Cooperative Threat Reduction (CTR) Biological 
Threat Reduction Program (BTRP) and the DOD Global Emerging Infections 
Surveillance and Response (GEIS) Program. \11\ \12\ These programs 
benefit both the military and the general public. They should be 
protected and strengthened.
---------------------------------------------------------------------------
    \10\ For more detail on how the DOD supports U.S. global health 
security efforts, refer to Thomas R. Cullison and J. Stephen Morrison, 
United States Department of Defense Role in Health Security 
(Washington, DC: CSIS, June 27, 2019), https://healthsecurity.csis.org/
articles/the-u-s-department-of-defense-s-role-in-health-security-
current-capabilities-and-recommendations-for-the-future/.
    \11\ ``Cooperative Biological Engagement Program,'' Defense Threat 
Reduction Agency, http://www.dtra.mil/Missions/Partnering/CTR-
Biological-Threat-Reduction/.
    \12\ See James B. Peake et al., The Defense Department's Enduring 
Contributions to Global Health _The Future of the U.S. Army and Navy 
Overseas Medical Research Laboratories (Washington, DC: CSIS, 2011), 
https://www.csis.org/analysis/defense-department's-enduring-
contributions-global-health.
---------------------------------------------------------------------------
    Specifically, we recommend that the U.S. Government expand DTRA's 
geographic authorities to operate in all continents where health 
security threats exist, including South America. Furthermore, support 
for military overseas infectious research laboratories should be 
sustained. DOD biological research and development programs often focus 
on diseases not studied in other venues and result in medical 
countermeasures that would otherwise be delayed or not developed at 
all.
    We need to exercise multilateral leadership to persuade partner 
countries to invest more of their own resources in preparedness.
    The financing gap in preparedness is, arguably, the most glaring 
problem we face in global health security. In the poorest and most 
fragile countries, where many needs are pressing and resources are 
constrained, leaders often face difficult trade-offs between investing 
in preparedness versus more tangible efforts like building roads or 
schools. Congress should press
    for U.S. leadership to launch a five-year challenge initiative at 
the World Bank that would incentivize long-term investment by fragile 
and conflict-affected countries in their own basic health security 
capacities. The United States would, under this plan, shoulder 20 
percent of the donor costs over the five-year period, using its 
influence to leverage other donors to cover the remaining 80 percent. 
The goal is that low-income countries eventually assume higher and 
higher responsibility for their preparedness. Such ownership is the 
only sustainable solution to the finance gap.
    We need far better confidence that we can access adequate, quick-
disbursing resources when a health or biosecurity crisis strikes.
    We simply cannot afford costly delays while scrambling to assemble 
resources. During moments of crisis, swift and early action is most 
essential. The Commission recommends that Congress increase contingency 
funding levels for the CDC and USAID, and that the U.S. Government make 
annual contributions to the WHO's Contingency Fund for Emergencies.
    The Commission argues that we need to launch initiatives that will 
allow us to operate far more effectively in insecure settings.
    The disordered world spans chronic and emerging conflicts, 
humanitarian crises, fragile states, and mal-governed and stateless 
spaces. The world is becoming more dangerous and insecure, and it is 
those very places where dangerous outbreaks are often occurring: 
witnessing what is unfolding in the Democratic Republic of the Congo, 
Syria, Yemen, Afghanistan, Pakistan, and Venezuela.
    In the meantime, however, access by U.S. civilian outbreak response 
experts into these insecure settings has become highly problematic. 
Across several cases, we see seasoned U.S. experts--the ``cerebral 
cortex'' to lead the international response--confined to the sidelines.
    The Commission advocates for the establishment of a U.S. Global 
Health Crises Response Corps, which will build upon and integrate 
existing CDC and USAID capabilities, to work with local partners to 
respond early to outbreaks and biosecurity incidents in disordered and 
insecure settings. This is a civilian capacity, which would have a DOD 
advisor. It would receive specialized training and exercises in 
building teams and would be provided with special support in terms of 
communications, intelligence, entry and exit protocols, and language 
and local mediation skills. It would also be equipped to strengthen 
local capacities to deliver services.
    The Commission also advocates that the U.S. Government strengthen 
and adapt programs and capacities to deliver health services in fragile 
settings that meet the special needs of acutely vulnerable populations, 
especially women and children. This means ensuring the continuity of 
immunization programs, the protection against and response to, gender-
based violence (GBV), and strengthening the delivery of maternal and 
reproductive health and family planning assistance. \13\
---------------------------------------------------------------------------
    \13\ Fleischman, Janet, How Can We Better Reach Women and Girls in 
Crises? (Washington, DC: CSIS, October 2019) https://
healthsecurity.csis.org/articles/how-can-we-better-reach-women-and-
girls-in-crises/.
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    The last area of priority concern to the Commission is the 
revolution underway in the life sciences, driven by technological 
transformations that pose both opportunities and risks.
    There is a race underway to develop new vaccines, therapeutics, and 
diagnostics in light of the mounting risks of emerging infectious 
diseases and growing resistance. It is essential to plan strategically, 
with strong private-sector partners, to support targeted investments 
that will accelerate the development of new technologies for epidemic 
preparedness and response. We argue that the U.S. Government should 
directly invest in the Coalition for Epidemic Preparedness Innovations, 
or CEPI, an international alliance that finances and coordinates the 
development of new vaccines to prevent and contain epidemics. The U.S. 
Government should also redouble its efforts to develop a universal flu 
vaccine and new antibiotics.
    We are also facing an unforeseen communications crisis in public 
health, fueled in part by the rapid spread of misinformation and 
disinformation online through weaponized social media. When 
misinformation crowds out facts, confidence in public health and 
medicine can erode precipitously, causing outbreaks of preventable 
diseases such as measles and polio. Congress should press for the U.S. 
Government to expand its efforts to better understand and address this 
complex phenomenon, effectively communicate accurate science to the 
American people, restore trust and confidence, and reclaim social media 
as a force for good in public and global health.
    Again, thank you for the opportunity to address you today, and I 
look forward to hearing your perspective. It is my sincere hope that we 
can work closely together to advance the U.S. health security agenda.

    Senator Ernst. Dr. O'Toole, thank you.

 STATEMENT OF DR. TARA J. O'TOOLE, SENIOR FELLOW AND EXECUTIVE 
                    VICE PRESIDENT, IN-Q-TEL

    Dr. O'Toole. Thank you, Madam Chairman, ranking member, for 
the invitation to talk about this very important and----
    Senator Ernst. Do you have your mic on?
    Dr. O'Toole. Thank you for having me here today and for 
holding this hearing on this very important, complex, and I 
think relatively neglected topic.
    As my two eminent colleagues have described, these 
biothreats are various, and all of them are quite terrifying. 
But I would like to suggest a hierarchy of biothreats that is a 
little different.
    First of all, we do live in an age of epidemics, and this 
is not going to change. It is a consequence of trade and travel 
patterns and the rise of urbanization in situations where 
people live in conditions of poor sanitation, nutrition, et 
cetera.
    Secondly, we have the deliberate bio-attack threats. 
Bioweapons have been with us a long time, but because of the 
revolution in biology that is going on, we have the capacity to 
make new, more powerful bioweapons that could evade all of our 
capacity to diagnose them and to treat them. It is very 
unlikely, given the difficulty of gathering intel on these 
programs, that we will have advance tactical knowledge of what 
weapon we might be facing or even where it might come from 
because I think, as the ranking member said, more and more 
people are going to have access to this technology as it 
becomes a foundational technology of the 21st Century economy.
    The third threat and in my mind in some ways worse than the 
first two is that we will fail to win the economic competition 
for the biorevolution. There is no question that we are in a 
geopolitical competition to wield these new technologies which 
I believe are going to undergird much of the 21st Century 
economy. I want to spend most of my time talking about that.
    We are in the situation today with regard to bioweapons and 
the threat of bioterror because of the advances that have been 
made in the life sciences in the past 40 years and the 
convergence of those advances in biology and biotechnology with 
digitalization.
    What we now understand is that biology is programmable. 
Life runs on code. It is not 1's and 0's. It is nucleic acids 
that make up the code, but we are beginning--we are past 
beginning--we are now able to read, write, and edit that code. 
Our ability to do so is improving exponentially, faster than 
Moore's Law.
    This is going to be phenomenally beneficial. It is going to 
impact multiple different industries, not just biomed, not just 
agriculture. That is because one of the industries that is 
rising is that of synthetic biology. Organisms are becoming 
programmable manufacturing systems, and we are already using 
organisms to make flavors, fragrances, new fabrics, materials 
with totally previously unknown properties, et cetera. Biology 
is likely to become the fundamental manufacturing platform of 
the future.
    We in the United States are the innovation engine of this 
new technology, and it is really several families of 
technologies. But China has said repeatedly and very 
forcefully--and they are backing up their words with actions--
that they intend to own the biorevolution. They are building 
the infrastructure, the talent pipeline, the regulatory system, 
and the financial system they need to do that. That is before 
we even talk about the secrets and the information and the 
intellectual property they are stealing from us, which is a 
small trickle of the contributions that they are building for 
their own economy.
    They have good reasons to go after the biorevolution. They 
have a huge population. They have the highest incidence of 
cancer on earth. Their population is aging. They are going to 
need to deal with challenges like Alzheimer's, just as we are, 
and they have to find an affordable way to deliver health care 
to their rising middle class.
    But I do want to note that the United States has not done a 
good job at translating biology into products. Our 
translational infrastructure for biology is mostly coming from 
small startup companies in the private sector, which is where 
In-Q-Tel does its business. Those are the innovation engines 
for biology and much else.
    We need to think about how we would build a more robust 
infrastructure particularly to manage epidemics, whether they 
are deliberate or natural. For example, we need to have the 
capacity, once an epidemic is noted, to immediately create 
diagnostics that could be used like pregnancy tests by the 
people themselves to determine who is sick and who is not. That 
would be strategically invaluable in managing the epidemic. We 
need to be able, as Dr. Inglesby suggested, to rapidly develop 
a new vaccine in response to an epidemic. We are within reach 
of technologies that can do that. We need to get much more 
ambitious as a country in how we are going to prepare for 
bioattacks and for natural epidemics. But we also need to tend 
to building infrastructure for securing and promoting the 
bioeconomy.
    Thank you.
    [The prepared statement of Dr. O'Toole follows:]

              Prepared Statement by Tara O'Toole, MD, MPH
    Good afternoon, Chairman Ernst, Ranking Member Peters, and 
distinguished members of the Subcommittee. Thank you for the 
opportunity to appear before you today to discuss how the Department of 
Defense can help counter the potential biological threats facing 
Americans.
    I have worked as a practicing physician, but much of my career has 
been spent in academia and government. I was a program manager at the 
Congressional Office of Technology Assessment, served as Assistant 
Secretary of Energy, and founded and led the Johns Hopkins and 
University of Pittsburgh biodefense centers from 1999-2009. I served 
five years as Under Secretary of Homeland Security for Science and 
Technology, where I oversaw the National Biodefense Analysis and 
Countermeasures Center and supported the creation of a new National Bio 
and Agro-Defense Facility. In 2014, I became executive vice president 
and senior fellow at In-Q-Tel (IQT), a non-profit investor for nine 
United States national security agencies, accelerating and shaping 
commercial startup technologies to advance the national interest.
    I appreciate the opportunity to come before you today and commend 
the Subcommittee for addressing this vital and neglected aspect of 
national security. I would like to emphasize four points.

        First, rapid advances in the life sciences, biotechnology, and 
        artificial intelligence, plus what we know about our 
        adversaries' programs, require a fundamental shift in United 
        States biodefense strategy. New and evolving technologies have 
        enabled a more dangerous and dynamic biothreat landscape than 
        is contemplated in current biodefense policy and programs.

    The past decades of biological science have brought us an array of 
powerful technologies such as DNA sequencing, gene editing, and 
synthetic biology. These and other advances have caused a revolution in 
our understanding of, and ability to alter, living organisms. We have 
learned that biology is essentially programmable: life runs on code. 
The knowledge and technologies needed to read, write, and edit this 
code are improving exponentially--faster than Moore's Law. In other 
words, the code of life, which consists of four different base pairs 
instead of ones and zeros, is being digitized, and this information is 
being stored in huge genomic data banks.
    These capabilities have and will continue to generate great 
benefits across a range of industries, such as new approaches to cancer 
treatment, and extremely efficient ways to produce complex chemicals 
and new materials. But these capabilities can also be exploited for 
evil purposes.
    All powerful technologies can be dual-use, and this is particularly 
true of modern biotechnologies. The same methods that enable the repair 
of genes which cause disease, allow us to genetically engineer bacteria 
to produce insulin, or alter a virus to create a vaccine, can be 
employed to create pathogens not seen in nature. Such pathogens, which 
could affect humans, animals, or plants, could be constructed to be 
particularly virulent, evade conventional diagnostic tests, or to 
resist available drugs and vaccines.
    As bioengineering methods advance, and especially as artificial 
intelligence methods are applied to DNA sequencing, synthesis, and 
editing, the deliberate creation of new pathogens will be within reach 
of many more actors. In addition, because techniques such as genomics 
and gene engineering are so useful in so many industries, and will be 
so central to the blossoming bioeconomy, more and more people around 
the world will have access to these technologies and know how to use 
them.
    The United States had a powerful, secret offensive biological 
weapons program during the Cold War, which lasted until 1969. Most 
people today, even in the military, do not understand how effective and 
advanced these programs were. The bioweapons we built then were 
intended to be strategic weapons, like nuclear weapons. The country 
tested these bioweapons in all conditions short of actual conflict and 
demonstrated them to have the large area coverage and lethality of 
nuclear weapons. And this was accomplished using 1960s technologies.
    Given the unavoidable expansion of these dual-use biotechnologies; 
the absence of any enforceable national treaties controlling bioweapons 
production and use; and the rise of competitive peer state adversaries; 
the United States must urgently consider how it will defend itself 
against what could be an existential threat to civilian populations, 
our agricultural assets, and warfighters.
    In addition to these man-made biological threats, we live in an age 
of epidemics. Naturally-occurring outbreaks of infectious disease have 
increased in frequency and impact over the past two decades. They are 
the consequence of modern trade and travel patterns, human intrusion 
into once remote ecosystems, and global urbanization with its attendant 
problems of poverty and poor sanitation. As has been seen with human 
outbreaks of SARS, MERS, Ebola, and Zika, and the ongoing epidemic of 
African Swine Fever in Asia which has resulted in the deaths of over 
300 million pigs, these outbreaks impose tragic costs in terms of 
death, suffering, economic losses, and social upheaval.

        Second, the United States should aggressively develop and apply 
        new and emerging technologies to create new capabilities needed 
        for a robust biodefense against natural and man-made 
        biothreats. Such a strategy would have the additional benefit 
        of strengthening United States competitiveness in the global 
        economy.

    The 2018 National Biodefense Strategy (NBS), many years in the 
making, is a detailed and coherent declaration of the broad 
capabilities needed to prevent, detect, contain, and recover from 
naturally-occurring epidemic disease. The NBS does not, however, 
recognize the urgency or potential challenges of protecting the nation 
from deliberate and covert bioweapons attacks, which could be far more 
devastating than even the most serious natural outbreak. The NBS also 
lacks a mechanism for continuous monitoring of the capabilities 
inherent in rapidly evolving biotechnologies. Nor does the document 
assign priorities, confer authorities commensurate with stated 
responsibilities, or provide new resources. Critically, in my view, it 
lacks a viable, appropriately ambitious, strategic plan for biodefense 
technology development.
    The biothreats posed by new biotechnologies, the potential for 
large-scale outbreaks in this age of epidemics, the rise of powerful 
nation state adversaries, and the feasibility of non-state actors 
wielding bioweapons, requires that the United States immediately commit 
to significant investments in developing and deploying the technologies 
needed for biodefense.
    To start, the national security community needs to develop a more 
realistic understanding of biothreats and their underlying dynamics. 
This will require competence in genomics, proteomics, computer science, 
and artificial intelligence--skills in short supply across the 
government. Also needed is a much more ambitious, strategic approach to 
the technologies needed for biodefense--that is, for detecting, 
managing, and quenching epidemics, including epidemics caused by 
pathogens not previously seen in nature, and possibly designed by 
humans.
    Relying on traditional, slow, and costly methods of drug and 
vaccine development and hoping that what we need will be available in 
expensive (and inevitably inadequate) stockpiles of medical 
countermeasures will not suffice. What is needed is a national 
commitment to the develop technologies that, for example, would enable 
rapid design and manufacture of medical countermeasures (diagnostic 
tests, vaccines, and therapeutics) at scales and in timeframes that 
could impact management of a large, lethal, and fast-moving epidemic. 
Also needed--and in use commercially today--are technologies that 
provide situational awareness during outbreaks. This requires the 
collection, wrangling, and analysis of essential data needed to make 
informed decisions about epidemic management. Such technologies, if 
deployed, should provide a defense against both engineered bioweapons 
and newly emergent natural diseases.

        Third, Department of Defense (DOD) leadership is critical to 
        United States biodefense, but talent and resources are 
        currently quite limited.

    DOD has historically played a critical role in response to disease 
outbreaks overseas. The key diagnostic test, vaccine, and therapy that 
were deployed to contain the 2014 West African outbreak of Ebola virus 
would not have been available but for DOD investments in R&D. DOD's 
long experience with technological development could make significant 
contributions to protecting warfighters and civilians against natural 
and man-made biothreats. The Department is not, at present, optimally 
organized nor stocked with the sufficient trained staff to execute this 
mission.
    For several years, DOD's Defense Advanced Resarch Projects Agency 
(DARPA) has executed important projects in biotechnology, including in 
projects designed to better understand biothreats, and has recently 
expanded its Biological Technologies Office (BTO) staff and budget. The 
quality of DARPA's work is excellent, and their staff is highly expert. 
But BTO is less than 50 people. The Joint Program Executive Office for 
Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) 
also has a number of excellent people working on important aspects of 
biotechnology, focused on providing warfighters protection from CBRN 
threats. But JPEO-CBRND's mission and budget could benefit from being 
considered a higher priority within DOD.
    The Committee might consider a review of current DOD biodefense 
programs with the aims of increasing coordination, encouraging risk-
taking, and placing an emphasis on capabilities for rapid medical 
countermeasure development, while providing sufficient resources to 
allow DOD officials to make meaningful contributions. Contract and 
budget mechanisms to effectively partner with innovative small 
companies, which populate most of the biotech landscape, will be 
essential, as will programs to recruit and retain talented scientists 
and engineers.

        Fourth, China has urgent and compelling reasons to aggressively 
        pursue advancements in biomedicine and biotechnology. But 
        China's geopolitical strategy to dominate the bioeconomy--and 
        indeed to ``own the biorevolution''--represents as great a 
        threat to United States national security as their bid to 
        assert dominance in artificial intelligence, quantum computing, 
        and space.

    China is planning, organizing, and financing efforts to become the 
world leader in biotechnology. The Chinese government rightly seeks 
ways to feed billions in the face of a changing climate, to bring 
medicines to a population with the world's highest cancer incidence and 
100 million diabetics, and to help its aging population stay healthy. 
Many nations share these goals, and we should find ways to cooperate to 
advance biology's humanitarian contributions.
    Yet it is also true that China sees biology as a route to expand 
its global power. China is using all the means available to an 
authoritarian state to reach its 5-year R&D plan to make the 
biotechnology sector 5% of its GDP by 2020. China is investing heavily 
in research, building new facilities, recruiting talent from abroad, 
reforming its regulations for drug approvals, establishing financial 
rules that favor Chinese companies, and linking its giant internet 
firms like Tencent and Alibaba to biotech development. Having watched 
the UK lead the industrial revolution and the United States lead the 
information revolution, China aims to capture the revolution in 
biotechnology.
    The United States should not cede this ground. The United States 
and its international partners must plan, organize, and invest to 
advance key aspects of biotechnology and then harness the vitality of 
our entrepreneurs to turn discovery into product. The first step is a 
national biotechnology strategy, one that can incorporate the vital 
contributions of the biodefense strategy but also transcend it, 
recognizing that biology will reshape world leadership as much as our 
quality of life on this planet.
                               conclusion
    The challenge of preparing for bioattacks and epidemics, natural or 
engineered, is integrally linked to broader imperative of maintaining 
America's leadership in biotechnology. Within the national security 
community there has been much focus on artificial intelligence, which 
clearly has enormous implications for our economy and our defense 
establishment, and already shapes our shopping habits, provides big 
data analyses, and operates robots. Biology will prove equally 
transformative--Americans just do not see it yet. This is a problem 
because biotechnology is both a humanitarian and geopolitical 
necessity.
    Biotechnology will dramatically and literally reshape our lives and 
our world. It will also become a significant source of national power--
economic, and in all likelihood military--as it creates entirely new 
possibilities, materials, and products. The question is whether our 
government can best position the United States to capitalize on this 
promise.
    Thank you.

    Senator Ernst. Thank you, Dr. O'Toole. Thank you to our 
witnesses.
    We will begin with 5-minute sessions of questioning, and I 
will go ahead and reserve my time after we get done with our 
first round here. I will go ahead and allow Ranking Member 
Peters to start with questions.
    Senator Peters. Thank you, Madam Chair.
    Actually I want to pick up on some of the comments you 
made, Dr. O'Toole. This question will be for the panel to 
expand on this.
    The United States-China Economic and Security Review 
Commission recently released its annual report to Congress, and 
in that report, the commission highlighted that following the 
2001 anthrax attacks, the United States was reliant on a single 
foreign source of the active ingredient, doxycycline, which the 
United States sought to treat possible greater exposure to 
anthrax.
    In another capacity, I am the Ranking Member of the 
Homeland Security Committee, and we are actually in the process 
right now of drafting a report on our reliance on foreign 
pharmaceuticals in this country as a national security issue 
that we need to think about and the fact that in many cases it 
is 100 percent or 80 percent of critical drugs are manufactured 
off the shore of the United States.
    It is my understanding that China is currently the world's 
largest producer of active pharmaceutical ingredients, known as 
APIs, which we rely on to make drugs, including those that 
would treat a biological weapon attack or a pandemic, as you 
mentioned, Dr. O'Toole.
    My question to the panel is, to what extent is the United 
States reliant on foreign services for key drug products and 
medical supplies such as syringes and needles and other 
critical medical supplies that we would need to respond to a 
biological attack today? What is your assessment of that? Dr. 
O'Toole, if you want to start.
    Dr. O'Toole. We are critically dependent on China for a lot 
of drugs, and we have been shipping our manufacturing capacity 
to Asia for over a decade now. There is not a CEO [Chief 
Executive Officer] of a major pharma company who has not been 
recruited by China to build facilities there.
    You know, biology is not part of the DNA of the national 
security community in this country. We have not been paying 
attention to biology as a national security asset or as a 
possible threat, and that has to change.
    The fragility of our supply chain in terms of drugs is a 
real problem. I would say that we have begun exploring the 
possibility of using synthetic biology to make these active 
pharmaceutical ingredients, at least some of them, which I 
think deserves serious consideration. If there were a natural 
pandemic in which the entire world needed drugs, I am sure 
China, as we would, is going to take care of their own people 
first. We do not have the surge capacity we need even to 
produce enough of a very common, well used medicine like 
doxycycline in time to deal with an epidemic.
    It was also said after H1N1 that if we actually had been 
able to vaccinate the entire population of the United States 
with the flu vaccine that we eventually got against H1N1, 
though it was late for the epidemic, it would have taken 4 
years' worth of needles to do that. I mean, we have very 
insecure supply chains for some of the most critical elements 
of what would be required medically.
    Senator Peters. Thank you.
    Any other panelists like to join in, please?
    Dr. Gerberding. I will just add that I think our medical 
supply chain is vulnerable even under everyday circumstances. 
Of course, in the context of a global health threat, we would 
be severely challenged for not just countermeasures but for all 
kinds of medical products.
    One area that particularly concerns me is the area of 
antibiotics because we know we are facing antimicrobial drug 
resistance on an accelerating scale. CDC just published its 
update last week outlining the severity of that threat, and we 
do not have a robust supply of antibiotics today.
    One of the ways that we do invest to support that potential 
situation is through the Strategic National Stockpile, which is 
a very important U.S. asset, and I think it needs to be 
reexamined in light of the now known realities of market 
failures and the shortages of the durable goods that we are 
going to need for any significant threat.
    Senator Peters. I think it is important when you said we 
have some challenges right now because we see drug shortages 
across the board of many drugs that are simply not available, 
and it forces practitioners to move to a different drug that 
tends to be a whole lot more expensive, but it may not be any 
more effective clinically. Antibiotics as well. I understand we 
have critical shortages in antibiotics today without a 
biological crisis. You can imagine under a biological crisis, 
it would be catastrophic. It is something that we should be 
focusing on immediately.
    Dr. Inglesby, would you like to add?
    Dr. Inglesby. Yes. I would just add that I completely agree 
with what you have just been saying, and I do think that we 
treat medicines too much like commodities that can be sourced 
for the lowest price somewhere in the world. But if we think 
about medicines we would need in a crisis when every part of 
the world would be looking for them at the same time, there 
should be at least a strategic examination of the kinds of 
things that we must have, and we should consider how we could 
bring some of those medicines back to the United States. 
Obviously, that cannot be done for all medicines. We are a very 
connected world, but there are some products that are important 
enough for national security, for public health crisis that we 
should be thinking about making them here.
    Senator Peters. Thank you.
    Senator Ernst. Senator Hawley?
    Senator Hawley. Thank you, Madam Chair.
    Dr. O'Toole, let me come back to something you said just a 
moment ago, that China wants to own the biorevolution I think 
you said. What steps do you see China taking to succeed in that 
endeavor?
    Dr. O'Toole. First of all, China has a very detailed 5-year 
plan, and biotechnology is in that plan in many different ways.
    First of all, their goal is to make biotechnology 5 percent 
of their GDP by 2020. They have changed regulations for their 
own FDA [Food and Drug Administration] to be more like ours so 
that they can more easily market to the world. They have 
created a talent pipeline that incentivizes their own students 
to go into the life sciences and to bioengineering. They have 
at least 20 different programs, according to the House 
Oversight Committee, intended to bring scientific talent from 
the rest of the world, mostly the United States, back to China 
using very attractive incentives to bring even very senior 
American scientists back to do research in China.
    As I said, they have enticed a lot of pharma companies both 
using incentives, as well as doing a lot of, I will call it, 
confiscation of IP [intellectual property] once they are over 
and operating in China.
    They have changed their financial regulations to benefit 
Chinese biotech companies.
    I think this is important to understand because they have 
such a long-term well thought-out plan. They are building 
infrastructure in the form of whole universities, incubators, 
bio-office parks, primate research facilities, high containment 
labs very deliberately in order to give themselves the 
capability of basically being the major biopharma power of the 
world. But they are not just aiming at biopharma.
    We did an examination of their capabilities in synthetic 
biology. If you map synthetic biology and the different pieces 
of science and technology that you need to do this to make 
organisms into manufacturing plants, you will see that the 
United States is all over the map. We have all kinds of 
creative companies who are working in all aspects of synthetic 
biology. If you compare that to China, what they are doing is 
building from the bottom up, from the fundamental 
infrastructure up to the more creative parts, and they are 
doing it at scale. We have nothing like this. This is something 
that I know DOD is getting interested in at this point. We 
ought to encourage that. We ought to take on synthetic biology 
as a national security priority in view.
    Senator Hawley. What other defensive measures would you 
suggest? Or maybe ``defensive'' is the wrong word. Maybe 
``proactive'' is better. But what measures from a policy 
perspective would you suggest and recommend that this country 
take in order to not only prevent China from owning the 
biorevolution but making sure that we do, for lack of a better 
expression?
    Dr. O'Toole. Well, this has been called the Sputnik moment 
in terms of the biorevolution. What we did back then worked 
pretty well. I think taking a look at the National Defense 
Education Act and really revving up science and technology 
education in this country--I would love to do it pre-
kindergarten through whatever. But I think we need talent fast. 
I would look at incentives to encourage young people to go into 
biology and biotech, but I would also look at how we get them 
into government because government really needs more technical 
expertise than it has easy access to right now. These people 
have a lot of options in terms of jobs. That is where I would 
start, is the talent pipeline.
    I also would consider making one of the national labs 
responsible for advancing some of these foundational 
biotechnologies, particularly the analytical part, the big data 
part of biology, so that we can strengthen the foundational 
technologies of genomics, and AI [artificial intelligence] 
applied to biology is going to be a very big deal. I could go 
on, but I do not want to take the whole hearing.
    Senator Hawley. That is very helpful. Thank you very much.
    Thank you, Madam Chair.
    Senator Ernst. Yes. Thank you.
    This is a very helpful discussion today. I really do 
appreciate it.
    I know there are a number of other committees that might 
have jurisdiction over these types of topics, whether it is 
USDA, whether it is Homeland Security. Here in the Senate Armed 
Services Committee, we have not had a hearing on this topic for 
20 years. Yes, pretty shocking. It is time. It is time to do 
this. Again, thank you for doing that.
    The reason I get very excited about this and so interested 
in it is the fact that every time I do meet with different 
agriculture commodity groups, in particular our Iowa pork 
producers, when I am back in Iowa, one of the key concerns that 
they have is actually how do we secure and protect our 
livestock against biological threats.
    My question to all of you is, with agriculture being such a 
significant part of not only our Iowa economy, but also the 
American heartland, how significant of a threat is there, and 
what can we do to mitigate that?
    Dr. Gerberding. I will start by just acknowledging that 
mother nature is a really good terrorist. China today is 
experiencing a dreadful outbreak of swine fever that has 
probably the caused the death or culling of at least 50 percent 
of their entire population of pork, which is the major source 
of protein for people in China. This is a major socioeconomic 
threat to the stability of the state of China today, and that 
is mother nature.
    To my knowledge, every state that has engaged in offensive 
weapons development has also looked not just at human terrorism 
or human biologic, but also animal and agricultural biologic 
capabilities. We have to assume that that is still an ongoing 
issue in state-based efforts, not to mention what might be 
cooked up in the garage of a terrorist somewhere along the way. 
These are easy things to do. We have very little surveillance 
and very little capacity in most of the vulnerable places in 
the world to do anything about it. I think it is a huge and 
unrecognized, under-mitigated threat.
    Senator Ernst. Thank you.
    Yes, Dr. Inglesby.
    Dr. Inglesby. Yes. I completely agree with Dr. Gerberding. 
I would say that the first alarming statistic is that we spend 
probably about 100 times less on agricultural threats than we 
do on human threats. I think there are many reasons for this, 
but one of them includes a kind of a reluctance in the U.S. 
Government to talk about this threat until quite recently. I 
think if you go back 5 years or 10 years in the interagency 
discussions around bioterrorism, USDA was not a strong player 
because USDA has a mission of promoting the food industry, and 
I think people felt at the time that that was kind of giving 
mixed messages and concerns and fears. I think that has 
changed, and I have been impressed with how USDA has been 
stepping out and really kind of being a serious player in the 
interagency around the National Biodefense Strategy 
development. I think programs are stronger than they were.
    But still they are small compared to the size of U.S. 
agriculture, the crops and the herds and the animals around the 
country. As Dr. Gerberding said, there are many natural threats 
that in terms of terrorism, simply moving a natural threat from 
one place in the world with some simple sample transfer into 
U.S. herds or crops would be relatively straightforward to do. 
There is a long list of diseases both for animals and for crops 
that could cause a terrible impact in our country.
    In general, I think there needs to be greater emphasis, 
greater funding for this problem. There is not an integrated 
risk assessment list for USDA. There are programs that focus on 
different diseases, but we could raise the entire enterprise by 
having a more organized list of what the biggest problems are: 
a stronger national veterinary stockpile, better surveillance 
programs for crops and wildlife. There are a number of concrete 
things that can be done, but building on recent successes in 
USDA--I think they are showing that they can really step up 
their programs, but they just need the support of the Congress.
    Senator Ernst. Yes. Dr. O'Toole, do you have a comment?
    Dr. O'Toole. I agree this is a big threat. The same forces 
that are driving natural epidemics are driving epidemics among 
animals. What is happening with African swine fever moving 
around the world is certainly going to happen again and again.
    What we need to do is the same. We really, really, as a 
matter of national security, need to get better at managing 
epidemics. We keep making the same mistakes again and again and 
again. The technologies to change this either exist or are 
within reach. For animals, we need rapid, cheap, easily 
manufactured pen-side diagnostics, as they are called, to 
figure out if pig A is sick and pig B is not, as opposed to 
killing all the pigs within a certain radius of an animal who 
is diseased. We can get those kinds of options if we are 
willing to invest in them.
    In agriculture, one of the advantages is you have a 
commercial push for these kinds of technologies if the U.S. 
were to lead some of the basic research that you do not have as 
easily in human outbreaks where the opportunity costs for the 
drug companies are so wildly out of sync that they are not 
going to develop new antibiotics, et cetera, as we have seen. 
But we can do a much better job at managing animal disease then 
we are doing now.
    Senator Ernst. My message back to Iowa is we can get there. 
We just need to step it up. Is that right?
    Dr. Inglesby. Yes.
    Senator Ernst. Okay. Thank you very much.
    Ranking Member Peters?
    Senator Peters. Thank you, Madam Chair.
    I think I will continue the line of thought by Chairman 
Ernst, protecting the agricultural industry. Michigan is also a 
big agricultural State, in fact, the second most diverse 
agricultural State next to California, with all sorts of crops. 
As Ranking on Homeland Security, I authored a bill to increase 
our agricultural inspectors at the border, which is critically 
important to protect that industry, as well as public health. 
We are understaffed when it comes to agricultural inspectors. 
We will hopefully change that if the House acts on the bill 
that we just passed out of the Senate. Not only human 
inspectors but probably the most sophisticated tool you can 
use, which are canine teams. Sophisticated noses of dogs is 
pretty amazing as to what they can pick as things are crossing 
the border.
    My question is--and especially, Dr. Inglesby, you are 
talking about how we need to do more--I will get the assessment 
of the panel. What sort of coordination is going on between 
USDA, the Department of Defense, the CBP [U.S. Customs and 
Border Patrol], or Homeland Security folks? We have to be able 
to identify where some of these outbreaks are around the world, 
alert folks here who are on the border protecting us. We have 
got to have a real coordinated system. What is your assessment 
of how coordinated that is? Do we need to do a lot more, and 
what would be your advice? Whoever would like to start. I would 
love to have all your thoughts.
    Dr. O'Toole. Well, I will start.
    I spent 5 years in Homeland Security. People do try to 
coordinate, but they do not have the tools they need to make 
this a very reassuring process.
    Without the technology--dogs are great. Love dogs, have 
one. It is really hard to----
    Senator Peters. We need more than dogs you are saying.
    [Laughter.]
    Dr. O'Toole. We really need more than dogs.
    Senator Peters. But they are great.
    Dr. O'Toole. They are good for some things. It is very 
difficult to quantitate how good they are or whether the dog is 
having a bad day. They are great as a first line of defense. 
They are not very reassuring as the line of defense.
    If you go to a port and you see what CBP is faced with day 
after day in terms of trying to figure out whether exotic pests 
are coming in, a big threat to agriculture, for example, they 
actually disassemble trucks, loaded trucks, and go through them 
box by box, packing straw by packing straw to find bugs and 
then compare them to the charts on the wall, what bug is this. 
We need more technology to do this more effectively. That is 
all there is to it.
    I think people are trying to coordinate amongst the 
agencies. I do not think they have the tools that they want. I 
agree with Dr. Inglesby. Agriculture has been late to the 
table. They need a much bigger research budget. I do not think 
you can do much about that from this committee. But again, we 
are under-investing in these areas in terms of R&D [research 
and development] and the translational science that has to come 
out of it. These things now are in the arena of national 
security.
    Senator Peters. Does anybody else want to add?
    Dr. Inglesby. Yes. I would just add just a couple of 
sentences.
    I would say one very encouraging thing was when the 
National Biodefense Strategy was getting developed in the lead 
up to 2018 fall, there were four agencies that were co-
conspirators or co-leads on the effort, and USDA was one of 
them, alongside DHS [U.S. Department of Homeland Security], 
HHS, and the Department of Defense. That was surprising to many 
people in the field because USDA had been kind invisible 
before. That was a sign of them really being either pulled or 
stepping up into the interagency. They are part of an 
integrated lab network that looks at CBRN [chemical, 
biological, radiological, and nuclear] threats alongside HHS 
and EPA [U.S. Environmental Protection Agency] laboratories. 
There is some kind of interaction there. They definitely do 
engage internationally with the Food and Agriculture 
Organization, which is the big organization around food safety 
in the world. I think there is some interaction, but I 
completely agree with Dr. O'Toole that they are on the rise, 
but they are still kind of starting from a lower position in 
terms of research and budget.
    Dr. Gerberding. I would just add a very small but important 
perspective, and that is the vast majority of the new or 
reemerging infectious diseases that are being evolved naturally 
are zoonotic diseases, meaning they arise from animals. The 
criticality of the integration between USDA and the CDC for 
infectious disease surveillance and adding into that the EPA 
because some of these diseases also involve the ecosystem--we 
really need a one-health approach to understanding emergence. 
Again, the technologies are sorely lacking because there is not 
an investment in that kind of not just interagency but 
interdisciplinary research and tech translation.
    Senator Peters. It is clear we need a whole-of-government 
approach here, and we are far from actually doing that now. I 
think that is certainly a big takeaway from that exchange from 
you, which I appreciate.
    I was just at the Detroit Metropolitan Airport seeing a 
demonstration of those dogs and others.
    But the one thing that was particularly concerning to me is 
the amount of actual biological material and viruses and others 
that are coming across. The people who are researchers--they 
are bringing all sorts of agents in, which they should not. In 
fact, I understand half of all the biological material that is 
stopped at the border is at Detroit Metropolitan Airport. I 
said is it because it is Detroit or because you are really good 
at it. The answer was probably a little bit of both. But it is 
concerning as to what are we not stopping. For whatever we 
stop, I am sure there is a lot that is getting through, which 
is why this is so critical that we put that together.
    If I may, I am a little over time, Madam Chair. If I may 
just ask another question.
    Dr. Gerberding, you mentioned the study, the Cycle of 
Crisis and Complacency. In your testimony here today as well, 
your oral testimony, you talked about where pandemics are 
occurring or where they start--the outbreaks are occurring 
around the world--they are usually places of great disorder, a 
lot of things happening there. The security issues are 
incredibly challenging where they come from. The Ebola outbreak 
in Congo is an example of that occurring in a place with 
regional conflict.
    In 2014, in the Ebola outbreak, the United States was able 
to deploy a real massive, kind of a heavy lift of folks to help 
deal with that situation. Three thousand combat engineers, 
mobile hospitals, and marshaled a combined team of medical 
professionals from the Army, the Navy, the Public Health 
Service. Actually the Michigan National Guard was engaged in 
Liberia, our partnership state there. We had a number of our 
guards people there that forward deployed as well.
    My question to you is to what extent do you think the DOD, 
when responding to these issues, really has to be doing more 
than just providing medical services? They are going actually 
have to stabilize a region. That is a broader mission than we 
normally think about when we are dealing with a potential 
outbreak of a pandemic, and yet the consequences of not 
containing that pandemic can be catastrophic. How do we square 
all that, and how should we think about deploying DOD assets in 
these kinds of emergencies?
    Dr. Gerberding. I think it is a very complicated set of 
issues. In the case that you cited in Liberia, our military was 
welcomed into the environment, and the mission there was 
primarily logistics, building infrastructure to support the 
relief efforts that were ongoing, hospitals, infrastructure, et 
cetera. Our Department of Defense is accustomed to providing 
that kind of humanitarian logistic support in all sorts of 
natural disasters, et cetera.
    But we were not there to provide security. Generally, we 
would like to think that the UN [United Nations] security 
forces or the local governments would have that responsibility, 
but as we have seen in the DRC, that is not always the case nor 
is it always successful. I think that challenges the role of 
the Defense Department in providing the security when the 
threat in one region could extend to be much broader or a 
threat to the United States. I think that is an area where we 
need a lot of strategic policy work on an ongoing basis.
    The other side of the coin and part of the reason why the 
commission report recommends the development of this ready 
corps is because we need to bring a certain kind of technical 
expertise, which is not the military's forte, but the 
surveillance, the epidemiology, the tech transfer, the 
diagnostics, et cetera, et cetera, that we need deployable 
troops who are trained to be able to go in and instigate those 
capabilities in environments that are not intrinsically secure. 
We do not have that capability right now. That is why it has 
been so challenging for the CDC, for example, to be in the DRC 
because we do not have the security context and we do not 
really have that kind of deployable, well trained, well 
exercised unit to serve in that sort of environment. It is an 
unmet need and one that I hope we would really put a higher 
priority on addressing going forward.
    Senator Peters. Thank you.
    Dr. Inglesby. I would maybe just add a comment.
    Senator Peters. Yes, please.
    Dr. Inglesby. In the West Africa Ebola response in 2014-
2015, in my view and I think the view of many, it really was a 
threshold moment when the President decided that the Department 
of Defense would become fully engaged in the operations around 
response. DOD did not send doctors and nurses, but they sent 
heavy lift. They sent their ship. They started building things. 
They already had laboratories there that were working on 
diagnostics. That was a real threshold moment.
    I think in the aftermath of that, as people have reviewed 
the DOD experience in West Africa, there still is a tension 
within the Department of Defense about the extent to which the 
Department of Defense should be involved in foreign operations 
around infectious disease crises. In my view, they are 
indispensable in terms of operations. If you really want 
something to be done by the U.S. Government, DOD has by far the 
most operational capacity, and there are going to be moments to 
do that. But I understand that in DOD leadership in the command 
leadership, that there is reluctance to have doctors and 
nurses, in particular, involved because of the way that it will 
affect overall operations.
    I think it is an open issue. I would urge the DOD to be 
involved in those kinds of operations, but I do not believe it 
is resolved within the strategy.
    The second thing I would say, just to echo Dr. Gerberding, 
is that in the current DRC Ebola response, the CDC has been 
indispensable in the last 20 Ebola responses since Ebola was 
discovered. In this response, they were held back by the U.S. 
Government for safety and security reasons because we had no 
way for the U.S. Government to determine that there was no safe 
way to have them in the field for a long period of time. That 
is beginning to change.
    But it does show that we will need in the future, since 
more and more outbreaks are happening in disordered, broken 
places in the world where things could spiral, get a foothold 
and then create chaos in the region--we are going to need, as 
Dr. Gerberding said, ways to operate in unsafe environments, 
ways to have our scientists and experts and public health 
officials be in places where outbreaks are out of control even 
if they are unsafe. I do think it is an important issue that we 
have not really resolved.
    Senator Peters. Probably new specialized units that are 
specifically trained for that.
    Dr. Inglesby. Yes. Units that are part of that that are on 
the DOD side, units on the CDC side, scientific side. I think 
they will need to be able to work together in ways we have not 
sorted out.
    Senator Peters. Thank you.
    Dr. O'Toole. May I comment on that?
    Senator Peters. Yes.
    Dr. O'Toole. I am all for training the special units, but I 
think the situation on the ground is going to outrun even the 
U.S. Government's ability to take care of it unless we have 
better technologies. We are much better off trying to figure 
out how we could make vaccines on demand and then distributing 
those than we are sending thousands of members of the armed 
services just to quell disorder. We have to get a strategic 
approach to epidemics that has got to look very different from 
what we are doing now. I think technology is the way through. 
Because of the biorevolution, there are possibilities out there 
that we could make good on if we invested in them.
    Senator Ernst. Thank you, Dr. O'Toole.
    I want to continue on a little bit with some of that 
technology. You had mentioned that the integration of 
artificial intelligence is important in staying ahead of 
various biothreats. If we can just discuss that briefly, I 
think that would be very helpful for me. Can you elaborate on 
how this type of technology would impact both the potential 
offensive and defensive applications with respect to biotech?
    Dr. O'Toole. Artificial intelligence of different kinds, 
machine learning, deep neural networks, and so forth, is 
already being used, for example, in drug discovery to hasten 
drug discovery. It is being used in medical imaging and in 
digital health in many different ways. But it is going to have, 
I think, the greatest near-term impact in biology on these 
foundational technologies, on genomics and synthetic biology in 
particular.
    If you think of genomics as you are trying read a code of a 
single genome--and today we are trying to understand what a 
particular gene does by comparing it to many genomes and trying 
to figure out this person is sick because that gene there is 
missing, to take a simple case. In that case, the bigger your 
library, the more genomes you have sequenced and put into a 
library that keeps things accurate and easy to access, you are 
advantaged. What AI is going to do is not only make it faster 
to sequence genomes, but they will be done so more accurately. 
Google has already done this and shown one way to do it, mostly 
using machine vision.
    What you then want to know is you want to understand how to 
read and write the genome once it is sequenced. What AI allows 
you to do is intelligently go through all of these 
multitudinous possibilities much faster and more accurately. 
Then you can iterate on it.
    It is going to improve sequencing. It is going to improve 
DNA synthesis, and it is going to improve DNA editing. There 
are already basic science experiments going on in all those 
fields.
    China, for example, has of course a philosophy that the 
state and the private sector are one and the same. The military 
and the private sector are one and the same. They have combined 
their big Internet giants, Alibaba, Tencent, and so forth with 
their biotech companies. Alibaba is investing in biotech. 
Tencent is helping BGI, Beijing Genomics, Inc., with their 
sequencing problems. They have recognized and are 
industrializing this combination of AI and biotech. It is 
mostly going to be beneficial. It is going to help us get new 
medicines faster. It is going to help us understand toxicity 
earlier. It is going to create whole new realms of products 
that we have not imagined yet. But they, as I said, are 
institutionalizing it. We are experimenting with it.
    Senator Ernst. I appreciate that. Again, we need to step up 
in this area and find those solutions.
    Your estimation--and I am drawing from that that there is a 
lot of work that we need to do. But how well postured is the 
Department of Defense in leveraging AI in a biodefense 
strategy?
    Dr. O'Toole. I do not think they have thought about it yet.
    Senator Ernst. I would probably agree with that assessment.
    Anybody else care to comment on that?
    [No response.]
    Senator Ernst. Dr. Gerberding, if we could go back a little 
bit. We were just talking about the collaboration between 
different governmental agencies. The Health Security Commission 
report released today by CSIS recommends restoring health 
security leadership at the White House National Security 
Council. When was this position established? Then why was it 
eliminated?
    Dr. Gerberding. In my experience in the context of some of 
the most difficult and threatening infectious disease 
outbreaks, inevitably someone is pulled to be the czar of the 
occasion for that particular situation. But in 2016, the White 
House did appoint a senior White House official reporting 
through the National Security Council to be responsible for a 
directorate that was charged with the preparedness and response 
to biologic threats. That directorate was established. It began 
its work, and then in 2017 it was disbanded. I do not know why 
it was disbanded. I think there were lots of changes. The 
administration changed and so forth. But I think the mentality 
often has been that these are important during a crisis, but 
the need for them dissipates once the acuity of the crisis has 
subsided.
    Senator Ernst. But the recommendation would be that it 
needs to be a consistent, stable position within the National 
Security Council.
    Dr. Gerberding. It has been an essential role for cross-
government collaboration in every single infectious disease 
situation I have ever observed.
    Senator Ernst. Do you believe then having that position in 
place, that person would be able to assist maybe in 
orchestrating the breakdown of various silos that exist between 
agencies?
    Dr. Gerberding. That would be a primary function, and that 
applies both to the planning and strategy that we have been 
talking about is missing across a number of our agencies, but 
also in the actual operations and in the aftermath. It is a 
continuous cycle, and it needs that constant strategic, 
iterative improvement over long arcs of time.
    Senator Ernst. Okay. We are going to go ahead. Senator 
Peters will have just a couple more questions.
    Senator Peters. Thank you, Madam Chairman.
    Dr. Gerberding, this was in your report as well. As you 
know, the Department has used the Cooperative Threat Reduction 
(CTR) program, which is also known as the Nunn-Lugar program, 
for the past 20 years to help us reduce some of the danger of 
biothreats in the United States. The program started out in the 
former Soviet Union to secure bioweapons stockpiles in their 
program, but we have continued to use that program. Your study 
specifically calls out this program as something that should be 
protected and sustained. Dr. Inglesby, I know you were involved 
in that as well.
    My question to you is what should the CTR program focus on 
in the future with respect to securing biological threats that 
could harm the United States in your estimation. If both of you 
could answer that and, Dr. O'Toole, if you want to jump in too.
    Dr. Gerberding. Yes. I will start.
    I had an introduction to this capability a number of years 
ago when there was an outbreak of plague in one of the 
countries that was formerly a part of the USSR [Union of Soviet 
Socialist Republics]. The question was, the plague that we were 
observing in animals was actually a sign that there was some 
offensive weapon development and deploying going on, and that 
resulted in an investigation comparing biologic fingerprints 
and so on and so forth. It revealed to me how important this 
effort was to provide resources and support for scientists to 
redeploy their technical capabilities in constructive 
directions and so forth. Since that time, this has come up in a 
number of other areas of the world.
    My own opinion is this is an extremely important 
methodology for repurposing scientific know-how and acumen, but 
also harnessing that expertise in ways that truly can hopefully 
transition into more constructive biotechnology solutions. I 
see it as a high priority for continuation, and I would look 
forward to Tom's view because I know we have had this 
conversation before.
    Dr. Inglesby. Yes. I also think it is quite a valuable 
program, and I think it is a place in the government that helps 
other labs and research facilities in the world develop 
biosafety practices and biosecurity practices that increase the 
chance that pathogens will stay safe in their refrigerators and 
not walk out with people or not be susceptible to theft or 
diversion.
    I think they also do a lot of important training programs 
to try and train trainers in different parts of the world. I 
know that CTR BTRP [Biological Threat Reduction Program], the 
bioprogram in CTR, recently had a training program in North 
Africa which trained biosafety and biosecurity leaders from a 
variety of North African countries in the context of violent 
extremist organizations trying to kind of think about the 
overlap between terrorism and potential diversion of samples. I 
think that is the kind of thing that they do very well. I think 
they are in nearly 30 countries, 29 countries in the world, and 
are doing things that other parts of the government are not 
doing.
    They also are trying to help build surveillance systems. I 
mean, there are many other agencies, especially CDC, that do a 
lot of very critical disease surveillance. I think with their 
relationships that they have established in laboratories, they 
can be helpful to that larger mission.
    Senator Peters. Dr. O'Toole, my last question to you, just 
to pick up on what you were you talking about with the advances 
in synthetic biology and CRISPR, all these new technologies 
that are going to change the world dramatically. It is an 
exciting time to live, but it is also a scary time to live at 
the same time.
    My question to you is that whenever you are dealing with 
advanced research in biology, it can often raise a whole host 
of moral and ethical issues that need to be addressed. Given 
the value system that we have in this country, we want to 
adhere to that at every step possible. However, other countries 
may have a different set of moral and ethical principles. How 
do you see those different principles in terms of biological 
research? How do you think about that? Is that a concern for 
you? As a committee, how should we be thinking about countries 
that are not going to be constrained in the same way we are 
likely to be constrained in this country when it comes to 
biomedical research?
    Dr. O'Toole. This is an area of profound questions that I 
think have to be approached very carefully and very seriously. 
We will be disadvantaged compared to China in some areas of 
biology, stem cells for example, because they are moving 
forward faster than we are. In the end, they may make more 
mistakes and we may get to the happy place sooner. As a 
physician, I believe very strongly in doing everything we can 
to avoid doing harm. Science is very empirical. Sometimes you 
make mistakes and you have to pull back and think again. I 
think this is going to be a knotty problem that deserves very 
sustained, high-level attention.
    When we started the human genome project in this country, 
we built in the funding for the project money to pay for 
research in ethics. I would recommend that we do the same thing 
again for synthetic biology, for gene engineering, and so 
forth. What it did was it laid the groundwork for a national 
dialogue, which I think was extremely constructive. All of the 
anxiety and true fear that popped up when we first started 
doing recombinant DNA back in the 1970s has proved not to have 
led to a terrible tragedy I think partly because we moved very 
thoughtfully forward. We have to create the foundation and the 
infrastructure for doing that again for these sciences.
    I would say about China, though, that they are in a 
terrible place vis-a-vis the health of their population. The 
reason they are moving forward so aggressively is that they are 
desperate for progress. When you look at the opinions of the 
Chinese people, they are much more acceptable of risk than I 
think Americans are in this realm. They are very interested in 
new technologies that they think could help cure disease, 
change birth defects, et cetera, et cetera. I do not read the 
gene-edited baby episode as China being negligent so much as I 
think it is a more nuanced view of that particular situation is 
warranted on our part. They have terrible problems that they 
are trying to fix, and that is part of their appetite for risk.
    Senator Peters. Thank you.
    Dr. Inglesby?
    Dr. Inglesby. Yes. I would just certainly agree. I would 
just add that the U.S. has had the opportunity to set standards 
in the world around science for a generation, and often when 
the U.S., especially in the world of science, the NIH [U.S. 
National Institute of Health], in partnership with other 
agencies, has taken positions or the recombinant DNA conference 
back in the 1970s which helped set standards for how to manage 
recombinant DNA science--I think those things do have a chance 
of taking hold elsewhere in the world. The more that we can 
kind of promulgate and seek partnerships around this, I think 
it is real. I think it can help.
    I am particularly worried about a very small realm of 
science, which has emerged in the last few years, which is 
science intending to create very pathogenic strains of 
pathogens. I think we have not taken the position we took in 
other kinds of technologies like gene editing or recombinant 
DNA science. We have actually gone in the other direction. We 
have been, I think, way in front of our headlights, and other 
countries are observing how we are operating and how we are 
funding that science. I think there are things that we could do 
in our own governance of science which would be, I think, a 
little bit more responsible. But generally speaking, I think 
the U.S. is able to help set some standards that other people 
pay attention to.
    I know China, just to speak about China--there was a 
meeting this summer where a number of Chinese scientists came 
over to talk about the gene-edited baby experience. I think 
there are many leading scientists in China who were shocked and 
appalled about how that all happened. I think they certainly 
have to think about their disease risks in their population, 
but they are also worried about how scientists kind of got out 
in front of their scientific establishment. I do not think it 
is a homogenous national reaction to gene editing. I think 
there are proponents of it, and there are people who are 
worried about it as well, even in China.
    Senator Peters. Thank you. I appreciate it.
    Senator Ernst. I am going to wrap up the hearing with just 
a quick question, and all of you can participate in this. I am 
going to give you the big four that we have. Near peer 
adversaries--but what is the current estimate of biological 
warfare capabilities? So, for example, the range of delivery, 
extent of biological weapons available, amount of biological 
weapons, so on and so forth. Low, moderate, or high for North 
Korea. What would your assessment be of North Korea and their 
biological capabilities? It is a fun little exercise. Very 
enlightening.
    Dr. O'Toole. I think every country in the world has the 
capability of delivering a devastating biological weapon, North 
Korea included. I think they are probably more intent on it. It 
is very difficult to collect intel out of North Korea. There 
are indications that they have a BW [biological warfare] 
program. Beyond that, we would have to be in a classified 
space.
    Senator Ernst. Absolutely.
    Dr. Gerberding. I would just say it behooves us to assume 
they do, whether we have evidence to back that up or not. I 
think it is more likely than not.
    But I would also just like to say one more time the best 
terrorist of all is mother nature.
    Senator Ernst. Yes, Dr. O'Toole.
    Dr. O'Toole. That gets said a lot, and I think it is no 
longer true. I think we have to understand that the capacity to 
build new, very powerful, very, for want of a better word, 
sneaky biological weapons has been unleashed, and it is widely 
accessible. We have got to start thinking about this in a 
national security context.
    Senator Ernst. Can we say that is probably true then of 
North Korea, Russia, China, Iran?
    Dr. O'Toole. Yes.
    Senator Ernst. Dr. Inglesby?
    Dr. Inglesby. I agree that any country with any kind of 
industrial capability, any kind of basic science program, which 
is almost all countries on the planet, if they chose to make 
biological weapons, they would succeed. There are not any 
technical barriers that would prevent a country from doing 
that.
    I think what is really useful at the moment is that we have 
a Biological Weapons Convention, which creates a very, very 
strong taboo against it, an international pariah status if you 
are caught making biological weapons. It is not a perfect 
treaty, and there are obviously countries that have cheated on 
it. But it is a helpful norm given that any country could 
certainly step up and develop and use biological weapons if 
they chose.
    Senator Ernst. Very good.
    On that happy note, I think we will go ahead and wrap up 
this hearing this afternoon. I do appreciate the input that has 
come from our panel of experts in this topic. It underscores 
the fact that we as the United States Government, as DOD, also 
need to truly step up what we are doing on biological warfare 
preparedness, as well as making sure that we are breaking down 
those silos that exist between DOD and maybe all of the other 
agencies that are working in these areas as well.
    With that, I want to thank you once again for joining us 
today.
    This will conclude our Emerging Threats and Capabilities 
hearing.
    [Whereupon, at 4:17 p.m., the subcommittee adjourned.]

                           APPENDIX A
                           
                           
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