U.S. GOVERNMENT PUBLISHING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Publishing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001

i 

98–913 2016

[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 
(II) 

SUBCOMMITTEE ON EMERGING THREATS AND CAPABILITIES 

JOE WILSON, South Carolina, Chairman 

JOHN KLINE, Minnesota 

BILL SHUSTER, Pennsylvania 

DUNCAN HUNTER, California 

RICHARD B. NUGENT, Florida 

RYAN K. ZINKE, Montana 

TRENT FRANKS, Arizona, Vice Chair 

DOUG LAMBORN, Colorado 

MO BROOKS, Alabama 

BRADLEY BYRNE, Alabama 

ELISE M. STEFANIK, New York 

JAMES R. LANGEVIN, Rhode Island 

JIM COOPER, Tennessee 

JOHN GARAMENDI, California 

JOAQUIN CASTRO, Texas 

MARC A. VEASEY, Texas 

DONALD NORCROSS, New Jersey 

BRAD ASHFORD, Nebraska 

PETE AGUILAR, California 

KATIE SUTTON, Professional Staff Member 

LINDSAY KAVANAUGH, Professional Staff Member 

NEVE SCHADLER, Clerk 
(III) 

C O N T E N T S 

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 

(1) 

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.] 
2 

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 
3 

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 longterm 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. 
4 

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 pre-
5 

pare 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. 
6 

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-ofgovernment 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? 
7 

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 dualedged 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 
8 

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 
9 

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 
10 

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. 
11 

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, 
12 

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 socalled czar model. And several other things were considered. 
13 

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.] 

A P P E N D I X 

FEBRUARY 3, 2016 

PREPARED STATEMENTS SUBMITTED FOR THE RECORD 

FEBRUARY 3, 2016 

(19) 
20 
21 
22 
23 
24 
25 
26 
27 
28 
29 
30 
31 
32 
33 
34 
35 

QUESTIONS SUBMITTED BY MEMBERS POST HEARING 

FEBRUARY 3, 2016 

(39) 

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 De-
40 

velopment 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. 

Æ