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

 
                         [H.A.S.C. No. 114-85]

       OUTSIDE VIEWS ON BIODEFENSE FOR THE DEPARTMENT OF DEFENSE

                               __________

                                HEARING

                               BEFORE THE

           SUBCOMMITTEE ON EMERGING THREATS AND CAPABILITIES

                                 OF THE

                      COMMITTEE ON ARMED SERVICES

                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             SECOND SESSION

                               __________

                              HEARING HELD

                            FEBRUARY 3, 2016

                                     
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                                   ______

                         U.S. GOVERNMENT PUBLISHING OFFICE 

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           SUBCOMMITTEE ON EMERGING THREATS AND CAPABILITIES

                  JOE WILSON, South Carolina, Chairman

JOHN KLINE, Minnesota                JAMES R. LANGEVIN, Rhode Island
BILL SHUSTER, Pennsylvania           JIM COOPER, Tennessee
DUNCAN HUNTER, California            JOHN GARAMENDI, California
RICHARD B. NUGENT, Florida           JOAQUIN CASTRO, Texas
RYAN K. ZINKE, Montana               MARC A. VEASEY, Texas
TRENT FRANKS, Arizona, Vice Chair    DONALD NORCROSS, New Jersey
DOUG LAMBORN, Colorado               BRAD ASHFORD, Nebraska
MO BROOKS, Alabama                   PETE AGUILAR, California
BRADLEY BYRNE, Alabama
ELISE M. STEFANIK, New York
                Katie Sutton, Professional Staff Member
              Lindsay Kavanaugh, Professional Staff Member
                          Neve Schadler, Clerk
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                            C O N T E N T S

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                                                                   Page

              STATEMENTS PRESENTED BY MEMBERS OF CONGRESS

Wilson, Hon. Joe, a Representative from South Carolina, Chairman, 
  Subcommittee on Emerging Threats and Capabilities..............     1

                               WITNESSES

Parker, Dr. Gerald W., Jr., D.V.M., Ph.D., Blue Ribbon Study 
  Panel on Biodefense Panel Ex Officio Member....................     3
Wainstein, Hon. Kenneth L., Blue Ribbon Study Panel on Biodefense 
  Panel Member...................................................     2

                                APPENDIX

Prepared Statements:

    Wainstein, Hon. Kenneth L., joint with Dr. Gerald W. Parker, 
      Jr.........................................................    20
    Wilson, Hon. Joe.............................................    19

Documents Submitted for the Record:

    [There were no Documents submitted.]

Witness Responses to Questions Asked During the Hearing:

    [There were no Questions submitted during the hearing.]

Questions Submitted by Members Post Hearing:

    Mr. Wilson...................................................    39
    
    
    
    
    
    
    
    
    
    
    
    
    
       OUTSIDE VIEWS ON BIODEFENSE FOR THE DEPARTMENT OF DEFENSE

                              ----------                              

                  House of Representatives,
                       Committee on Armed Services,
         Subcommittee on Emerging Threats and Capabilities,
                       Washington, DC, Wednesday, February 3, 2016.
    The subcommittee met, pursuant to call, at 3:31 p.m., in 
room 2118, Rayburn House Office Building, Hon. Joe Wilson 
(chairman of the subcommittee) presiding.

  OPENING STATEMENT OF HON. JOE WILSON, A REPRESENTATIVE FROM 
SOUTH CAROLINA, CHAIRMAN, SUBCOMMITTEE ON EMERGING THREATS AND 
                          CAPABILITIES

    Mr. Wilson. Ladies and gentlemen, I call this hearing of 
the Emerging Threats and Capabilities Subcommittee of the House 
Armed Services Committee to order. I am pleased to welcome 
everyone here today for today's hearing on outside views of 
biodefense for the Department of Defense [DOD]. This hearing 
will provide an overview of the findings and recommendations 
from the recent bipartisan report of the Blue Ribbon Study 
Panel on Biodefense.
    It is critical that the United States maintain a dynamic 
national defense against the growing threat posed by biological 
weapons and naturally occurring diseases. The Department of 
Defense plays a large role in the U.S. biodefense enterprise, 
contributing biodetection tools, medical countermeasures and 
protection, and decontamination technologies. The recent 
response to the Ebola outbreak illustrates the importance of 
the Department of Defense's biodefense contributions to broader 
government and global efforts.
    This hearing is especially timely in preparing for our 
subcommittee hearing next week with the Department of Defense 
on countering weapons of mass destruction policy and programs 
for the fiscal year 2017. The findings and recommendations 
discussed today will be important aspects of our review of the 
fiscal year 2017 Department of Defense biodefense enterprise.
    Our witnesses before us today are the Honorable Ken 
Wainstein. He is the Blue Ribbon Study Panel on Biodefense 
panel member. Additionally, Dr. Gerald Parker, the Blue Ribbon 
Study Panel on Biodefense Panel ex officio member.
    I would like now to turn, but he is not here, to Mr. Jim 
Langevin, but Lindsay has assured us that he will be here soon, 
and we will proceed. And so we would like to begin right this 
moment. Thank you.
    [The prepared statement of Mr. Wilson can be found in the 
Appendix on page 19.]

STATEMENT OF HON. KENNETH L. WAINSTEIN, BLUE RIBBON STUDY PANEL 
                   ON BIODEFENSE PANEL MEMBER

    Mr. Wainstein. Thank you very much, Chairman Wilson. It is 
a real pleasure to be here today on behalf of the Blue Ribbon 
Study Panel on Biodefense and to represent our co-chairs, 
Governor Tom Ridge and Senator Joe Lieberman, as well as the 
rest of our colleagues who worked with us on the Study Panel.
    As you mentioned, last October we released our bipartisan 
report in which we provided an assessment of our national 
biodefense, and offered 33 recommendations that we believe will 
improve our ability to defend against biological threats of all 
types--against those that are intentionally and maliciously 
introduced, against those that are naturally occurring, and 
also against those that result from accidental release.
    Before highlighting a couple of these recommendations, I 
would like to briefly discuss the biological threat that we 
currently face. I will start with the anthrax attacks of 2001.
    We don't need to remind you up here on Capitol Hill about 
those attacks and about how they were a tragic wakeup call to 
the Nation about the possible consequences of deadly biological 
agents falling into the wrong hands.
    As tragic as those attacks were, however, there is good 
reason to believe that future attacks could be much more 
devastating. For one, we know that are there are stockpiles of 
biological weapons throughout the world that may now be or may 
become accessible to our enemies. When the U.S. discontinued 
its offensive biological weapons program in 1969, other 
nations, including the former Soviet Union, continued to 
produce stockpiles of biological agents, stockpiles that 
represent an appealing opportunity for rogue nations and those 
terrorist groups, like ISIS [Islamic State in Iraq and Syria], 
that are intent on inflicting the maximum possible damage 
against our Nation and against our people.
    As we on the panel heard from a number of experts who 
appeared before us, including former Senator Jim Talent, former 
Representative Mike Rogers, and others, our enemies are 
currently taking specific steps to develop, or to procure, 
biological weapons for use against us. Intelligence indicates 
that they are actively trying to recruit scientific experts; 
they are seeking control of laboratory, manufacturing, and 
other infrastructure for biological weapon production and 
development; they are talking about how best to deploy 
biological weapons; and they are making concrete plans for the 
use of these weapons.
    In light of this information, we believe that it is not a 
matter of if, but rather when and how soon a biological attack 
will be launched against our Nation, our people, or our allies; 
and the fundamental question is whether we are equipped and 
prepared to handle this imminent threat. And sadly, our panel 
found that the answer to that question is no. Despite a number 
of important strides taken in the past 14 years since the 
anthrax attacks, we have failed to develop the coordinated and 
comprehensive biodefense that is necessary to meet and defeat 
this threat.
    To address this failing, our panel made 33 recommendations 
that we believe will improve our Nation's overall ability to 
prevent, deter, detect, respond to, recover from, and mitigate 
biological threats. And if I may, I would like to highlight 
just a couple of those recommendations.
    First, recognizing that leadership is the key to success 
for any such effort, our initial recommendation is that the 
White House take point in coordinating the national biodefense, 
and specifically that the Vice President take charge of that 
effort; that he establish and operate through a Biodefense 
Coordination Council comprised of representatives of the 
responsible agencies, and that as a first step he and the 
Coordination Council jointly develop a national biodefense 
strategy to replace the current piecemeal strategies, 
directives, and policies with a comprehensive strategy that 
contains both the overarching vision and the specific policy 
and operational objectives that are necessary to drive the 
construction of a viable national biodefense.
    In conjunction with this and the other recommendations that 
are directed primarily to the executive branch and its State, 
local, tribal, and corporate partners, we also recommend that 
Congress take steps to contribute to this effort. Specifically, 
we recommend that Congress follow the lead of this committee 
and enhance the level and the intensity of its oversight in the 
biodefense area.
    Progress in this biodefense area will require strong 
encouragement and strong oversight from Congress. And while we 
applaud this committee for taking the step of having this 
hearing, we recognize that it is only a first step; a first 
step of what will be a long-term national effort to build an 
effective and enduring defense system to protect against the 
biological threat.
    It is important to remember that after the terrorist 
attacks of
9/11, 2001, we succeeded in doing exactly that, and we built a 
defense system that has largely protected us against the more 
general traditional terrorist threat. With commitment and with 
support from both the executive and legislative branches, I am 
confident that we can do that again, that we can build a 
defense system that will protect us against the specific threat 
of biological attack and infection.
    I want to thank you, sir, for holding this very important 
hearing and for having me here today, and I look forward to any 
questions that you may have.
    [The joint prepared statement of Mr. Wainstein and Dr. 
Parker can be found in the Appendix on page 20.]
    Mr. Wilson. And, Mr. Wainstein, thank you very much. And it 
is ironic that you would reference anthrax. I was elected in a 
special election right at that time, December 2001. What an 
introduction to Washington.
    Dr. Parker.

  STATEMENT OF DR. GERALD W. PARKER, JR., D.V.M., PH.D., BLUE 
    RIBBON STUDY PANEL ON BIODEFENSE PANEL EX OFFICIO MEMBER

    Dr. Parker. Good afternoon, Chairman Wilson, Ranking Member 
Langevin, and members of the subcommittee. Thank you for the 
invitation to appear before you today. It is an honor to be 
here with Honorable Ken Wainstein representing the Biodefense 
Blue Ribbon Panel.
    Mr. Wainstein covered the threat and the need for a 
biodefense strategy. For my part, I would like to bring a few 
programmatic issues to your attention.
    As a retired member of the Armed Forces, I spent many years 
working to protect the Nation, our soldiers, and their 
families. I am proud to tell you that the Department of Defense 
institutions, such as USAMRID [U.S. Army Medical Research 
Institute of Infectious Diseases], which I once commanded, 
contribute significantly to U.S. biodefense alone and in 
concert with our civilian and international partners. These 
organizations have dedicated scientists, they conduct cutting-
edge research, they discover new countermeasures, and they 
provide science-based knowledge to operations. In summary, they 
are the go-to scientists to counter biothreats for the DOD.
    While this is commendable, it does not mean that these 
human institutions are infallible, as has been recently seen in 
both military and civilian labs in the DOD and HHS [U.S. 
Department of Health and Human Services]. They have made 
mistakes, and if left uncorrected will contribute to the 
Nation's biological risk.
    The recent laboratory safety and security breaches at 
Dugway illustrate this point. As you know, despite following 
protocols, viable anthrax spores were inadvertently sent to 
other labs over an extended period of time. As it turns out, 
there is an incomplete scientific understanding of the 
inactivation process, there are no standardized protocols for 
inactivation, and the checks that Dugway had in place were 
insufficient.
    It is important to note that DOD's risk assessment 
concluded that this incident posed little risk to public 
health; but we must assume that without continued focus on 
smart improvements in biosecurity and biosafety, this will 
happen again somewhere in the Nation's laboratory network with 
a worse outcome. We cannot afford institutional failures.
    One of the basic tenets of DOD is that we must protect the 
warfighter. No other agency can do that for DOD. This is a top 
priority. In the case of biodefense, it means addressing a 
number of vulnerabilities.
    Military personnel are the most likely to be exposed to 
infectious disease threats, some which the world has never seen 
before, and some which do not have any treatments. Ebola is a 
good example of this, but there are worse examples. This means 
that we have to protect our soldiers. We need trained and 
equipped medical teams with logistical support ready to respond 
to outbreaks or bioterror attack. We have to have rapid 
diagnostics, effective biodetection, as well as global 
biosituational awareness.
    These and other issues drive a number of DOD programs, to 
include the Chemical and Biological Defense Program, the 
Military Infectious Disease Program, the Cooperative Bio 
Engagement Program, GEIS [Global Emerging Infections 
Surveillance and Response System], DARPA [Defense Advanced 
Research Projects Agency], and others, who have broadly 
followed either AT&L [Acquisition, Technology, and Logistics], 
Health Affairs, and OSD [Office of the Secretary of Defense].
    I want to emphasize there are many hardworking, dedicated 
professionals working in these programs, but we need to better 
prepare for the eventual use of biological weapons. We believe 
that DOD needs to clarify parameters for military support to 
civilian authorities in response to a domestic biological 
attack, update and implement military biodefense doctrine, 
hopefully tiered to a new national strategy as recommended by 
the panel.
    Let me provide one programmatic example of the need to 
include military-civilian collaboration. There is a 
longstanding need for effective biodetectors on and off the 
battlefield. Mr. Langevin and others that serve on the House 
Committee on Homeland Security are well aware of the DHS 
[Department of Homeland Security] experience with BioWatch, a 
biodetection system that a number of experts believe is 
insufficient to the needs of the Nation. DOD also has a 
separate biodetection program and it's had one for years. And 
although DOD and DHS are communicating better than ever on 
these programs, this is just an example where we need an 
integrated program, in this case biodetection, driven by strong 
centralized leadership, guided by a national biodefense 
strategy, that we can field effective and affordable solutions 
in a timely manner for our soldiers and citizens.
    DOD and the interagency face a number of other challenges. 
These include the need to establish effective BW [biological 
weapons] intelligence, authoritative microbial forensics and 
attribution, and decontamination and remediation.
    I can go into detail about these later, but before closing 
I would like to add that the lines between BW and infectious 
diseases have blurred, and DOD's positive contributions to 
global health security through our OCONUS [outside the 
contiguous United States] laboratories, our global 
biosurveillance programs, and cooperative bioengagement cannot 
be overstated.
    In closing, I would like to thank the members of the 
subcommittee again for this opportunity to appear before you 
today. Thank you.
    [The joint prepared statement of Dr. Parker and Mr. 
Wainstein can be found in the Appendix on page 20.]
    Mr. Wilson. I thank both of you. And we are going to begin 
now. And Katie Sutton is going to maintain a strict 5-minute 
rule for all persons, including me, on questions.
    And so right away, one of the recommendations, Mr. 
Wainstein, of the report is to improve the intelligence 
community efforts to address the biological threat. Can you 
further elaborate on the specific measures that could be taken 
to indeed achieve better estimates of biological threats?
    And then, specifically, you had indicated that scientists 
were recruited, that their facilities could be used. A concern 
that I have had is a major city in Iraq, being Mosul, that with 
the capture by ISIL [Islamic State of Iraq and the Levant], 
that there would be hospitals, there would be medical 
facilities, there would be universities that might have the 
facilities that could facilitate the development of weapons to 
attack the American people.
    Mr. Wainstein. Yes, Mr. Chairman, I think you have put your 
finger on one of the big risks here.
    Look, the bio threat has always been one that has caused 
people in the government to lie awake and worry about at night, 
and especially since the anthrax attacks.
    But I think what is new now is what you just identified, 
which is the primary adversary, it used to be Al Qaeda, we were 
concerned about Al Qaeda generating weaponized anthrax, 
probably in caves or in pretty primitive facilities. We now 
have ISIS that is infinitely better funded, infinitely better 
resourced, more people of all types, not just fighters, but 
people of educational backgrounds, scientists and the like. 
And, as you indicated, they have facilities, they have the 
footprint where they can put together a program like this and 
have the continuity and the protection to do that, but they 
also have hospitals and labs and that kind of thing right there 
in their territory.
    So the threat, I think, has always been there, and we have 
heard about it from a number of different commissions and 
panels. But this, I think, it is a new threat, a newly enhanced 
threat.
    In terms of the intelligence and what the intelligence 
community can do, look, this was an unclassified exercise, we 
didn't get a classified briefing from the intelligence 
community, but we did learn about sort of the general state of 
intelligence. And it is clear to us that the intelligence 
community would be doing a much better job if they were linked 
in with a more centralized, coordinated, all-of-government 
effort. Then their requirements and their intelligence 
collection can be more focused in order to enhance the overall 
effort to identify the bio threat, think of best ways of 
dealing with it, and then taking those steps.
    So I think that the intelligence community is going to be a 
major player in this, what we present as a potential overhaul 
of the biodefense bureaucracy, and it is going to require some 
direction from the top.
    Mr. Wilson. Well, thank you again for your efforts bringing 
this to the attention of the American people, both of you.
    In the report, the panel noted that work dealing with cyber 
threats to pathogen security is nascent and that the United 
States is not yet well positioned to address cyber threats that 
affect the biological science and technology sectors. Could you 
further describe the cyber threat identified by the panel? What 
role could the Department of Defense play in responding to this 
biological security cyber threat?
    Dr. Parker. Thank you, Mr. Chairman. I will try to address 
that for you.
    We are in the age of biology, and biology is all about 
information, from the genetics, the proteomics, and so forth, 
as well as our medical records. And so it is all about 
information. And much of our information now, it is all 
digital. And we are also in the era of synthetic biology where 
in the not too distant future new and dangerous pathogens can 
actually be synthesized.
    So the ability to protect this information and make sure 
the information does not get misused is actually a very 
critical step. And I believe there are things being put in 
place to help protect that information, but I think this is an 
area that is going to require increasing focus as we move 
forward so that this information doesn't get hacked and 
misused.
    Mr. Wilson. And has there been proper public-private 
cooperation, including universities, with the government to 
address this?
    Dr. Parker. I think it is still, I would say, a work in 
progress to begin to address how we make sure and protect. And 
it is a dual-edged sword. On the one hand, we have to be able 
to share information to collaborate for solutions, but on the 
other hand, we have to make sure that we can protect the 
information so it is not being used for nefarious purposes by 
bad people.
    So we do have to be able to work it both ways, but it is a 
work in progress. And I think more attention will need to be 
put in place here so that we can have the appropriate security, 
but also be able to share in the scientific discoveries and 
work that needs to take place in collaboration across that 
space that you mentioned.
    Mr. Wilson. Well, with both of you, we look forward to 
working with you in the future.
    I now shift to Congressman Pete Aguilar of California.
    Mr. Aguilar. Thank you, gentlemen. I appreciate the report 
and the work that you are doing.
    Dr. Parker, you touched on this a little bit, and the 
chairman mentioned it, the coordination between DHS and DOD. 
Can you talk a little bit about that and the role within the 
biomedical advanced research groups and DOD as well, what more 
we can do to foster that? The chairman mentioned obviously the 
potential to have events abroad and here nationally as well. I 
represent the city of San Bernardino where the incident was 
last month, and obviously it could have gone a different way.
    And so making sure that the coordination between local law 
enforcement agencies also exists within a DHS interface or DOD 
interface is something that I think our communities also want 
to see us take serious.
    Dr. Parker. Thanks for the question, and absolutely. I 
think you know I spent a lot of my career in government and was 
a major proponent, cheerleader, whatever word, for interagency 
coordination. And there are a lot of people working very hard 
at trying to drive interagency collaboration and communication, 
and I would say they are doing a good job. But on the other 
hand, we can do better.
    And it really comes back to the central tenet of the 
findings of the report that the need for having strong 
centralized leadership, driven by a solid strategy, and then 
tied to the budget, and department, agency accountability, with 
clear leads and supporting roles identified, timelines, 
metrics, et cetera, et cetera, et cetera. It really comes down 
to that leadership and strategy is going to be necessary to 
improve our collaborative interactions across the departments 
and agencies.
    People are working, they are trying to work very closely 
together, but sometimes process can be more important than the 
outcome. And the only way to get above that, again, strong 
leadership, strategy, accountability, tied to the budget, and 
somebody willing to make some hard decisions. But I do not want 
to give you the impression that people aren't working hard to 
collaborate and communicate, because they are.
    Mr. Aguilar. No, no, absolutely, and we wouldn't indicate 
that. But areas, specific ways that we can use the committee 
and use the work that we are doing to highlight those positive 
examples as well as areas of deficiency where we can continue 
to improve, I think is important.
    Dr. Parker. And I think this is also critical too, because 
in the report we are not recommending increases in the budget, 
but it really comes down to how can we best use the budget 
available.
    Mr. Aguilar. Sure.
    Dr. Parker. And it comes down, again, to that leadership, 
accountability, and the strategy to enhance that collaboration 
across the interagency space.
    Mr. Aguilar. Mr. Wainstein, anything to add?
    Mr. Wainstein. No, thank you.
    Mr. Aguilar. Mr. Chairman, I will yield back. Thank you.
    Mr. Wilson. Thank you, Congressman.
    We now proceed to Congresswoman Elise Stefanik of New York.
    Ms. Stefanik. Thank you, Mr. Chairman. And thank you, Dr. 
Parker, for your testimony. Mr. Wainstein, good to see you 
again. You and I served in the White House together.
    Mr. Wainstein. Great to see you.
    Ms. Stefanik. I am excited to be able to connect with you.
    I wanted to talk about the report's comments on the rapid 
development and employment of developmental Ebola vaccines, 
which was, quote, ``a remarkable achievement.'' But the report 
also noted that the general medical countermeasurement 
development is very risk averse and is not focused on 
innovation. Can you talk about what some of the lessons learned 
from the development of the Ebola vaccination and how we can 
improve how our MCM [medical countermeasures] development, how 
we can improve that?
    Dr. Parker. Yes. First, like the report says, medical 
countermeasures development, acquisition, procurement, it is 
really hard. There is risk for everybody involved. It is hard 
for the government, it is hard for industry.
    I will say, echo as it was reported, it was an amazing 
achievement, how the Federal Government, industry surged to try 
to produce an Ebola vaccine very quickly. But we still don't 
have an Ebola vaccine.
    What is really critical is what we do between outbreaks, 
between attacks. If we don't have something available in the 
stockpile or soon to be licensed, it is going to be very hard 
to have it and surge.
    I think that is really one of the big lessons with the 
Ebola outbreak. What is critical is between epidemics, not in a 
crisis situation. And it comes back, then, to leadership, 
strategy, and accountability; then down at the lower level on 
what can we do to improve our medical countermeasure 
development.
    We have got to be willing to take risk in that in between 
outbreaks. We have got to bring more innovation to that. Tried 
and true past technologies aren't going to necessarily work. We 
have to also think about the regulatory pathways, how can we 
improve that. And the FDA [Food and Drug Administration] is 
thinking about those things.
    Ms. Stefanik. So are increased public-private partnerships 
a way we can improve that? How can we better employ public-
private partnerships?
    Dr. Parker. Well, I think they are key, because there is no 
way that government alone can do this, there is no way industry 
can do this. This is a space that, just like tropical neglected 
diseases, biodefense, there is no commercial market, or very 
little commercial market. So that public-private partnership is 
going to be key.
    Some of the things I would say actually that DOD does 
pretty well is has a little bit more transparency in what their 
requirements are and what the 5-year planning budget cycle 
looks like. So a little bit more transparency in what the needs 
are, what the requirements is kind of critical. Reducing some 
of the bureaucratic decisionmaking delays is very critical, 
particularly for industry. The panel heard that a lot from 
industry during our look at this.
    Even in DOD, the Federal acquisition contracting, is not 
best business practices for the small companies. We are not 
talking about large pharmaceutical companies that are part of 
the biodefense space. It is primarily small biotechnology 
companies that are having a difficult time surviving. And many 
of the Federal acquisition contracting is not conducive to that 
industry best practices.
    I would applaud DOD. Recently, particularly the Joint 
Program Executive Office, has announced an intention to use 
more use of other transactional authorities. That is a move in 
the right direction.
    Ms. Stefanik. Mr. Wainstein, do you have anything to add?
    Mr. Wainstein. No, thanks. He covered it.
    Ms. Stefanik. Great.
    Well, I have 1 minute left. Can you elaborate on possible 
incentives that could be used to improve public-private 
partnerships? So we understand this is a way to bring 
innovation to the table, but what specific incentives should we 
put into place?
    Dr. Parker. Well, there are a number of, I think, 
incentives that the panel heard during our study. And since I 
am not from industry, I am academia now, I may not be the best 
to actually get down in the details of specific incentives that 
would be good for industry.
    But I think the point is, what we recommend in this, is 
that we really need to have industry and government come 
together and really talk about what works. And industry will no 
doubt come up with a pretty good list. And there is no doubt 
that some of those may not work for government. But on the 
other hand, government is going to have to be a little bit more 
open than they have in the past and actually not just listen, 
but do something about it.
    So I think the real key thing I think that we captured 
pretty well in this report is the need to really identify those 
with the public and private partners, talk about what is 
practical and can be done, and begin to implement. And there 
has been discussion about it before, but nothing has been 
implemented, or very little.
    Ms. Stefanik. Thank you. My time has expired.
    Mr. Wilson. Thank you, Congresswoman.
    We now proceed to Congressman Brad Ashford of Nebraska.
    Mr. Ashford. Thank you.
    Doctor, thank you, and thanks for the report.
    We at the University of Nebraska have engaged in--and I 
know you are aware of this--a number of initiatives, starting 
with Dr. Phil Smith a few years--well, 10 or 12 years ago--in 
some of his initiatives that have evolved into the Ebola 
facility at UNMC [University of Nebraska Medical Center]. And 
there is great hope that they can expand that facility further 
to provide training and other, obviously not only for Ebola, 
but for the whole grouping of threats here.
    And again, I thought Congresswoman Stefanik's point is well 
taken, is that facility and that initiative at UNMC is a 
public-private partnership as well. And so the kind of training 
that would go on there, and I know your report reflects this, 
is not only would be training healthcare professionals, 
training others that are going to be engaging in these threats.
    How would you see that training regimen working? And I know 
you have mentioned it in the report, but if you could just 
elaborate on it.
    Dr. Parker. Well, first, thank you for the contribution by 
the University of Nebraska, outstanding professionals that 
really stood up to the task when the Nation needed them very 
badly. So thank you for that.
    And it really is that training education. We really need to 
go back to the basics. And I think back, actually, after the 
anthrax letter attacks that we have already talked about here 
early on, a lot of the programs, particularly, say, the 
hospital preparedness, the CDC [Centers for Disease Control and 
Prevention] public health preparedness grant programs that 
really expanded after 9/11 really focused a whole lot of effort 
on infection control, the medical management of biological 
casualties, some of the basics that were really needed across 
this country so that we could do that.
    I think somewhere in that intervening time, 2005, 2006, we 
began to lose that edge, and I think that is apparent in the 
Ebola outbreak.
    Mr. Ashford. There seems to be such a--your report reflects 
this--but such a revival in this comprehensive approach now. It 
is not just about reacting, obviously, but it is being very 
proactive, and it is a very welcome report.
    I hesitate to mention to the chairman that in Nebraska--not 
everything happens in South Carolina, I don't want to make 
light of that--but, I mean, we have certain--we love South 
Carolina, but--thank you, Mr. Chairman.
    Dr. Parker. But I would say, just to follow on, we have 
only made recommendations.
    Mr. Ashford. Right. No, I understand. But had that 
roadmap----
    Dr. Parker. These recommendations need to be implemented 
and acted upon so that we can correct some of the deficiencies 
that I think are apparent in the system now.
    Mr. Ashford. And what is interesting about the effort, I 
think, not only at UNMC, but certainly Emory and other 
institutions around the country, is these institutions do stand 
ready to make the investment in plant and equipment to move 
forward.
    So thank you very much. It is a great report.
    Dr. Parker. Thank you.
    Mr. Wilson. Thank you very much, Congressman. And, hey, 
from a South Carolina perspective, we really appreciate 
Nebraska. You are a hearty people to live where you live.
    And, hey, talk about hearty people, it is really tough, San 
Diego. Congressman Duncan Hunter from California.
    Mr. Duncan. Also in the South.
    Mr. Wilson. Yes, yes.
    Mr. Duncan. Southern California.
    I just want to piggyback on Ms. Stefanik's question. You 
didn't really answer. What are the actual incentives? Besides 
saying transparency and let's get together and sing Kumbaya, 
what are the actual incentives to keep private companies with 
stockpiles or to keep them ahead of the whole curve in the 
first place? What is DOD doing, with the FDA, for instance, to 
say, hey, we are going to add you to the, what is it, the 
priority voucher program, like we added Ebola to last year, 
what are we going to do to add anything else that our service 
members face overseas with the FDA and DOD so that industry is 
ahead of it and not playing catch-up when bad things happen?
    Dr. Parker. Well, I think actually I go back to perhaps 
what the panel actually concluded, that maybe the most 
important incentive goes back to the original Project BioShield 
in 2004, that having that appropriation up front so that 
industry knew that there was going to be a market for the 
countermeasures that were going to be developed, that is 
probably the single most valuable incentive.
    Mr. Hunter. And then DOD says, hey, we are going to focus 
in these three areas, for instance, and that is where the 
appropriation is going to go towards, we are going to go 
towards that?
    Dr. Parker. Well, I guess, Project BioShield, that is 
focused on HHS and DHS and the relationship of who does the 
threat determinations, who works on the countermeasure 
development against those threats.
    DOD doesn't have a similar appropriation like that, but at 
least DOD has 5-year budgeting plans, that short of an 
appropriation up front, that 5-year budgeting plan for DOD is 
pretty solid and does give industry an idea of what is going to 
come. Of course, those budgets can change every year, again----
    Mr. Duncan. How do you know what to stockpile or what you 
need private industry to do when you don't know what the bad 
guys may have or what they may use?
    Dr. Parker. In the old days, I would say the Cold War, 
post-Cold War era, it was much easier. There was a list of and 
the intelligence had a list of potential pathogens, and they 
have been codified in the CDC list. And so that could be 
anthrax, smallpox, plague, the hemorrhagic fever viruses, 
botulinum neurotoxins.
    Those are traditional BW threats. We still need to be 
worried about those. There is a reason why we need to have a 
huge stockpile of antibiotics against anthrax. Anthrax is 
special.
    But actually you asked a very good question, because the 
problem is getting harder. In fact, lists are really no more 
applicable today, although we still need to pay attention to 
those six I mentioned, but it is getting harder today in the 
era of biotechnology, synthetic biology. It could be anything. 
And so it is a challenge.
    Again, go back to BW intelligence. We need to put more 
emphasis on that. And in defense of the intelligence community, 
it is a hard, hard problem. Bio in the WMD [weapons of mass 
destruction] space is the hardest of the hard.
    Mr. Duncan. I want to ask you this. So you know where we 
have people at throughout the world. So I would just ask, is 
there one, is there anything just screaming at you in the face 
where you are like, we have people here and we are not prepared 
for this?
    Dr. Parker. Yes, there are certain areas. I would say on 
the Korean Peninsula, I will give you an example, that we have 
been--the DOD, in fact, has been working very hard with 
counterparts in the Korean military and the CDC against some 
pretty known thought to be high priority threats. And the 
doctrine is evolving and should be different, because we need 
to be worried about not only force-on-force military deployment 
of biological weapons in a scenario like that, we need to be 
concerned about covert use against not only the military, but 
the civilian population.
    So these are areas where we have not only a large number of 
military forces, we also have strategic partnerships with our 
allies that happen to be in very large population centers that 
are living very close to a determined enemy.
    Mr. Duncan. Let me ask this, you made me think of another 
question, then. You talk about Korea, so I am guessing China 
and Russia have the technological capability to be able to 
develop different bad things to affect people. Do you have to 
worry about that in places like Syria, where the lab might be 
in someone's kitchen? I mean, it is not like they are high tech 
compared to the North Koreans or the Russians or Chinese or 
even the Pakistanis.
    Dr. Parker. Well, I think, yes, the first question really 
kind of got into that. These areas, the problem is very hard. 
And these small clandestine labs, it would be very difficult 
for our intelligence community to ever discover these.
    Mr. Duncan. But they don't have the technology to be able 
to make more sophisticated bad things either, do they? You 
can't make that in a kitchen in Syria. It takes a lab.
    Dr. Parker. You can make some BW pathogens that can cause 
significant number of casualties in a relatively small 
clandestine laboratory, and also get it in a condition that 
would be relatively easy to disseminate. It is a serious 
threat.
    Mr. Duncan. Thank you. Thanks, Mr. Chairman.
    Mr. Wilson. Thank you, Congressman. And thank you for 
citing the threat to the concentrated population of Korea, 
because actually what you are saying is the capital Seoul has a 
population of nearly 20 million people, very compact, very much 
at risk.
    Congressman Pete Aguilar.
    Mr. Aguilar. Just one more question, gentlemen, since we 
have you and I get one more bite at the apple. And, Dr. Parker, 
you talked about leadership. And could you just describe to me 
the discussion and the decision by the panel to 
institutionalize and empower the Vice President as the kind of 
point of contact and the focal point within the report?
    Dr. Parker. Yes. I will start. Ken probably has some 
observations as well due to his White House experience.
    It became pretty clear early on that leadership was an 
issue, it was a factor, and the need to somehow instill, 
inculcate stronger leadership. So the panel actually looked at 
various options, to include reinstituting the special advisor 
for health security and biodefense, even actually had the three 
previous special advisors testify before the committee. Looked 
at that model. Looked at the so-called czar model. And several 
other things were considered.
    But it kept coming back to who has got really the ear of 
the President, that also has the ability to make some hard 
decisions, that can affect the budget, and who can really also 
represent those outside of government the best, speak on their 
behalf, and also encourage those outside government, 
particularly State governments, local governments, and lead 
efforts needed there as well. And it really kind of backed into 
the decision that the position who is best suited to do that is 
the Vice President.
    Ken, do you want to----
    Mr. Wainstein. Good question. And I concur with everything 
Jerry just said. I mean, at first blush when you hear a panel 
recommending that the Vice President should take on this one 
sort of discrete area, you think, gosh, that is a little bit of 
a bold proposal. But for all the reasons Jerry mentioned, I 
thought it made sense. And I was the Homeland Security Advisor 
the last year of President Bush's administration and obviously 
my job was to ensure that there is coordination on major issues 
and that we get progress and we get consensus and the like, and 
that is tough to do with small issues, day-to-day issues; 
incredibly difficult to do when you are trying to take the 
bureaucracy and build something new, something much stronger 
than what we have now.
    And so my favorite reference is what the government did 
after 9/11, and I think it is pretty much a success story. Not 
absolute success, but the government really went through an 
overhaul after 9/11 to meet the traditional terrorist threat 
that we saw on 9/11, and it had been pretty successful with it. 
But that took an enormous effort driven directly by the 
President and obviously with Congress in lockstep.
    This is a very serious threat. It is more discrete, it is 
more focused, but it requires almost as many different actors 
within the executive branch to work in concert. And our thought 
was, gosh, we could have one department head sort of anointed 
as the coordinator, but then you would have the same 
bureaucratic tensions that you would always have when equals 
are having to listen to--you know, there is one person 
designated as higher than the others.
    You could just have somebody in the National Security 
Council, like we have had in the past. Bob Kadlec was the 
person in the Homeland Security Council when I was there, very 
effective, but probably not enough to really get across the 
goal line.
    So we thought, look, the Vice President has taken these 
kind of tasks on before, this Vice President has taken on these 
kind of tasks, and this is one that really warrants it, given 
the threat. So we thought, look, we will put that out there. 
And I know the chairs have had meetings with the White House 
about this. And I think people are intrigued.
    Mr. Aguilar. Thank you.
    Mr. Wilson. And thank you very much, Congressman.
    And I would like to thank both of you for being here this 
afternoon. And Congressman Langevin, the ranking member, sends 
his regrets. We are imminent to voting and he is close to the 
floor. But I am very grateful for the work of Ms. Sutton, Ms. 
Kavanaugh. And we are adjourned.
    [Whereupon, at 4:12 p.m., the subcommittee was adjourned.]

      
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                            A P P E N D I X

                            February 3, 2016
    
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              PREPARED STATEMENTS SUBMITTED FOR THE RECORD

                            February 3, 2016

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              QUESTIONS SUBMITTED BY MEMBERS POST HEARING

                            February 3, 2016

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                   QUESTIONS SUBMITTED BY MR. WILSON

    Mr. Wilson. The report discusses the importance of ``building upon 
defense support to civil authorities.'' The panel found that ``U.S. 
warfighter preparedness for and protection against biological attacks 
is inadequate'' and that the ``current military biodefense doctrine and 
policy falls short of adequately protecting the warfighter and ensuring 
that military operations continue unimpeded.'' Can you describe the 
information that the panel gathered to reach this conclusion? What 
specific shortcomings need to be addressed to improve warfighter 
preparedness and protection against biological attacks?
    Mr. Wainstein and Dr. Parker. The Panel gathered information to 
support these conclusions from subject matter experts, including Dr. 
George Poste (one of our ex officios) and others who spoke at our major 
meetings held on December 4, 2014; January 14, 2015; March 12, 2015; 
and April 2, 2015. Please see Appendix C of our bipartisan report, A 
National Blueprint for Biodefense: Leadership and Major Reform Needed 
to Optimize Efforts for meeting agendas and speaker names. A number of 
open source documents also support our conclusions regarding the 
characteristics of personal protective equipment (also referred to as 
protective overgarments), medical countermeasures, detectors, and 
surveillance systems, as well as doctrine and policy that would lead to 
the likely exposure of military personnel to biological weapons before 
they were able to don protective equipment/garments and take other 
protective actions during attacks. The Department of Defense also 
freely describes and admits to difficulties in preparing warfighters to 
execute combat operations in biologically contaminated environments. 
The Department clearly communicates its concerns regarding biological 
(and other) weapons of mass destruction threats and uses those concerns 
to justify funding for its research and development programs (e.g., 
those that produce and improve upon medical countermeasures, protective 
overgarments and equipment, detectors, surveillance systems). 
Specifically, although their biodefense laboratories appear to be doing 
exemplary work in the science and technology discovery phase, the lack 
of progress on biodefense vaccine development (where some vaccine 
candidates have languished in advanced development for close to 15 
years) is not encouraging and serves as an example of the inability to 
improve readiness through the use of preventive vaccines. To improve 
warfighter operational preparedness, the Panel recommends that the 
military go beyond using smoke and other non-biological visually 
obvious 2 substitutes and find ways to realistically simulate the use 
of biological agents in training environments. Additionally, the Panel 
recommends that the military require its personnel to do more than wear 
protective overgarments and work in areas thought to have sufficient 
protections against these agents for hours on end, as this sort of 
training only tests warfighter ability to withstand such conditions and 
not the ability to prevent infection. To improve protection against 
biological attacks, the Panel supports ongoing military research 
efforts (particularly those conducted by the Defense Advanced Research 
Projects Agency and the National Laboratories on behalf of the 
Department of Defense) to improve materials used in overgarments and 
equipment, all military biodefense efforts, and the military-civilian 
exchange of relevant information. The Panel also supports similar 
efforts made by civilian public and private sector agencies, but notes 
that needed exchange of information does not occur automatically. While 
both military and civilian sectors would benefit from information 
exchange, the Department of Defense must necessarily take the lead and 
initiate such exchanges for the benefit of its warfighters.
    Mr. Wilson. The Department of Defense played a large role in the 
U.S. Government response to the Ebola crisis. What do you think is an 
appropriate role for the Department of Defense to play in responding to 
global epidemics, such as Ebola? Are there aspects of the response that 
would be more appropriate for other parts of government? What role 
would you recommend the Department of Defense play in response to the 
recent Zika virus outbreak?
    Mr. Wainstein and Dr. Parker. The Department of Defense often 
provides humanitarian aid during domestic and international crises that 
exceed the ability of the civilian sector to respond effectively. For 
example, during the recent Ebola crisis, the Department of Defense 
provided the United States Agency for International Development efforts 
with logistics, engineering, and training support. The Department of 
Defense also undertakes a number of other activities that not only 
support the warfighter but also support broader U.S. governmental 
responses. For example, the National Center for Medical Intelligence 
gathers epidemiological, biostatistical, health care, and public health 
infrastructure data and information to characterize environments to 
which warfighters deploy, and shares this information. The Department 
of Defense also sometimes shares with civilian agencies information 
produced by its laboratories, surveillance systems, and intelligence 
activities throughout the world. In addition, the Department of Defense 
supports the Global Health Security Agenda through the Global Emerging 
Infectious Disease Surveillance and Response System and the Department 
of Defense Overseas Research Laboratories. These unique laboratories 
directly and indirectly support deployed forces and contribute to 
medical and public health diplomacy in support of U.S. foreign policy 
and national security objectives. These are all appropriate activities. 
The Department of Defense Chemical and Biological Defense Program 
develops medical countermeasures to protect military forces facing 
biological threats. While the Panel believes it is within Department of 
Defense purview to develop medical countermeasures for its own 
personnel, we note that its civilian counterpart (i.e., the Department 
of Health and Human Services Biomedical Advanced Research and 
Development Authority, BARDA) often works on similar medical 
countermeasures for non-military purposes. While the Public Health 
Emergency Medical Countermeasures Enterprise (an interagency 
coordinating body) exists and the Department of Defense is a member, 
the Panel does not believe that these two agencies coordinate optimally 
to cover gaps, avoid redundant efforts, and aggressively accelerate 
development efforts between outbreaks. This became clear in 2014 when 
in response to the global crisis, BARDA announced it would fund the 
development of Ebola vaccines. This surprised the Department of 
Defense, which had been working on vaccines for some time without 
knowing that BARDA was interested in producing Ebola vaccine for 
civilian purposes. This situation occurred because there is no leader 
who stands above the departments and agencies, maintains awareness of 
their activities, ensures the appropriate prioritization and execution 
of a medical countermeasure strategy, and prevents redundant efforts. 4 
In 2014, military personnel deployed to West Africa without the benefit 
of Ebola vaccine or therapeutics. The lack of vaccine limited both 
civilian and military responses and readiness. These biodefense 
vulnerabilities place Department of Defense missions at risk. The 
threats of biological weapons, as well as emerging and reemerging 
infectious diseases, imperil force protection and force projection at 
home and abroad. While the Department of Defense trains and equips its 
forces to operate in radiologically contaminated environments, this is 
far from the case for biologically contaminated environments, where 
related training is inadequate and equipment is far less advanced. 
Diseases that spread across the world quickly affect the United States. 
It is, therefore, entirely appropriate to question the role of the 
Department of Defense in both international and domestic response. The 
Department's role in civil support lacks clarity and dedicated 
resources. There is a mutual lack of understanding between the military 
and civilian sectors and considerable suspicion regarding operational 
capabilities. The Department of Defense must enunciate a technically 
feasible and politically acceptable doctrine for biodefense activities 
if it is to fulfill its primary responsibilities for force protection 
and projection while planning for an inevitably expanded role in 
domestic/homeland defense and global response during major biological 
events. If the Department of Defense proactively takes needed steps to 
develop a robust biodefense capability to protect its own assets, it 
will be better able to meet broader civil support requirements. The 
U.S. Government cannot deploy Department of Defense personnel and 
assets each time a new disease emerges. Military involvement must be 
limited to assisting with those diseases that impact national security 
and take into consideration the current spread of military resources, 
as well as the possibility that the military may need to move to defend 
against enemy activity that poses a greater threat to the nation. In 
the case of Zika response, the Panel believes that the role of the 
Department of Defense should include many of the same activities it 
executed during Ebola, with the exception of targeted deployments of 
military personnel (due to the current spread and nature of the virus 
and disease). As stated in Recommendation 33 of the Panel's report, the 
nation and the world need a new global response apparatus based on 
public-private partnerships, not solely on U.S. military resources and 
capabilities.

                                  [all]
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