[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]

                         [H.A.S.C. No. 113-63] 



                       THE DEPARTMENT OF DEFENSE 



                               BEFORE THE


                                 OF THE

                      COMMITTEE ON ARMED SERVICES

                        HOUSE OF REPRESENTATIVES


                             FIRST SESSION


                              HEARING HELD

                            OCTOBER 11, 2013


                         U.S. GOVERNMENT PRINTING OFFICE 

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                      Washington, DC 20402-0001


                    MAC THORNBERRY, Texas, Chairman

JEFF MILLER, Florida                 JAMES R. LANGEVIN, Rhode Island
JOHN KLINE, Minnesota                SUSAN A. DAVIS, California
BILL SHUSTER, Pennsylvania           HENRY C. ``HANK'' JOHNSON, Jr., 
RICHARD B. NUGENT, Florida               Georgia
TRENT FRANKS, Arizona                ANDRE CARSON, Indiana
DUNCAN HUNTER, California            DANIEL B. MAFFEI, New York
VICKY HARTZLER, Missouri             JOAQUIN CASTRO, Texas
JOSEPH J. HECK, Nevada               SCOTT H. PETERS, California
                Peter Villano, Professional Staff Member
                 Mark Lewis, Professional Staff Member
                          Julie Herbert, Clerk

                            C O N T E N T S





Friday, October 11, 2013, Biodefense: Worldwide Threats and 
  Countermeasure Efforts for the Department of Defense...........     1


Friday, October 11, 2013.........................................    29

                        FRIDAY, OCTOBER 11, 2013
                         DEPARTMENT OF DEFENSE

Langevin, Hon. James R., a Representative from Rhode Island, 
  Ranking Member, Subcommittee on Intelligence, Emerging Threats 
  and Capabilities...............................................     2
Thornberry, Hon. Mac, a Representative from Texas, Chairman, 
  Subcommittee on Intelligence, Emerging Threats and Capabilities     1


Bennett, Dr. Bruce W., Senior Defense Analyst, RAND Corporation..     6
Giroir, Dr. Brett P., M.D., Interim Executive Vice President, 
  Texas A&M Health Science Center, Texas A&M University..........     9
Russell, MG Philip K., USA (Ret.), Sabin Vaccine Institute.......     7
Smithson, Dr. Amy E., Senior Fellow, Monterey Institute of 
  International Studies..........................................     4


Prepared Statements:

    Bennett, Dr. Bruce W.........................................    42
    Giroir, Dr. Brett P..........................................    65
    Russell, MG Philip K.........................................    61
    Smithson, Dr. Amy E..........................................    33

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:

    [There were no Questions submitted post hearing.]
                         DEPARTMENT OF DEFENSE


                  House of Representatives,
                       Committee on Armed Services,
        Subcommittee on Intelligence, Emerging Threats and 
                          Washington, DC, Friday, October 11, 2013.
    The subcommittee met, pursuant to call, at 11:11 a.m., in 
room 2118, Rayburn House Office Building, Hon. Mac Thornberry 
(chairman of the subcommittee) presiding.

                        AND CAPABILITIES

    Mr. Thornberry. The subcommittee will come to order.
    Mr. Langevin, I am sure, is on the way, and he will be here 
in just a moment, but we will go ahead and get started.
    Today's hearing is a reminder that the national security 
threats to our Nation do not go away or wait patiently while we 
try to straighten out our budget woes. There are very real and 
very significant dangers in the world, and the foremost target 
is America and Americans.
    Part of our job on this subcommittee is to look ahead for 
the threats coming down the road and for those that may loom 
larger in the future. Biological threats must be at or near the 
top of that list.
    For example, while the world's attention has been focused 
on Syria's chemical weapons, DNI [Director of National 
Intelligence] Clapper testified earlier this year that Syria's 
biological program may be more advanced than we previously 
thought. We believe that other nations, such as North Korea, 
have such capability, as well.
    David Hoffman's book, The Dead Hand [The Dead Hand: The 
Untold Story of the Cold War Arms Race and Its Dangerous 
Legacy], discusses the Soviet program, which engineered a 
pathogen within a pathogen so that victims got sick, seemed to 
get better, and then got hit with a second pathogen and quickly 
died. In other words, there seems to be an endless number of 
biological threats, from the crude to the sophisticated.
    And then, of course, there are terrorists. The former chief 
technology officer for Microsoft, Nathan Myhrvold, recently 
published a paper on the Lawfare Web site, entitled ``Strategic 
Terrorism,'' that has been generating a fair amount of 
discussion in national security circles. He argues, 
convincingly I think, that technology gives small groups more 
lethality than ever, that the incentive for more spectacular 
attacks will grow, that biological weapons may be the most 
dangerous form of attack, that terrorists using such weapons 
cannot be deterred, and that we are not adequately prepared.
    We are anxious to get our witnesses' perspectives on these 
issues, and they are well qualified to provide that. We want to 
examine the threat, the Department of Defense's (DOD) role in 
meeting the threat, and other Government and national resources 
that should also play a part.
    I would yield to Mrs. Davis for any opening comment she 
would like to make at this moment on behalf of Mr. Langevin.
    Mrs. Davis. Mr. Chairman, thank you very much.
    This is important. And part of it is under what 
circumstances we believe our most pressing threat in this area 
might be. So I look forward to the discussion, and thank you 
very much.
    And I believe Mr. Langevin is here, and we will give him an 
opportunity when he comes in. Thank you.
    Mr. Thornberry. Excellent timing for an entry. And I yield 
to the distinguished ranking member for any opening comments he 
would like to make.


    Mr. Langevin. Thank you, Mr. Chairman.
    And to our witnesses, I appreciate you being here today on 
this very important topic. It is obviously very timely and a 
    And I want to thank the chairman for focusing the Nation's 
and the subcommittee's attention on this issue of biowarfare.
    Biowarfare is obviously a very troubling prospect, 
something that weighs heavily on all of us. And while less 
prevalent in the news than nuclear or chemical warfare, it is 
an extraordinarily lethal capability that poses a significant 
threat to the United States, including from terrorism.
    Now, there are also many unknowns and problems unique to 
biowarfare, including, most obviously, the unlikelihood of an 
attack warning and the difficulty in crafting effective 
countermeasures, if they can be created at all.
    And these organisms can be incredibly lethal, as Major 
General Russell highlighted in his written testimony. Tularemia 
is one of the most infectious agents know, with an infectious 
dose containing less than 10 bacteria, an infinitesimal amount 
when one considers that a simple powder aerosol can deliver 
hundreds of thousands of those organisms.
    Further, other agents such as botulinum toxin, plague, and 
many viral hemorrhagic fevers lack approved vaccines at the 
present time.
    These difficulties are put into stark relief when we look 
at the use of weapons of mass destruction in Syria. Although 
the nerve agent sarin was used as opposed to a biological 
agent, the attacks in Syria nonetheless demonstrated the 
reality of the WMD [Weapons of Mass Destruction] threat to U.S. 
and allied forces. Even more troubling, given Syria's past 
biological warfare capability and the instability, to put it 
mildly, in the country, the threat of proliferation is real and 
    Now, that is the background for today's hearing, and it 
should add some urgency to the issue. This is not an academic 
discussion. And I certainly look forward to what our panel has 
to say about proliferation risks from Syria and elsewhere.
    Now, within the United States Government, the problem is 
obviously compounded by the wide spectrum of agencies with a 
piece of the biodefense puzzle. Outside of DOD's [Department of 
Defense] Chemical and Biological Defense Program, the 
Department of Health and Human Services, Agriculture, Homeland 
Security, and the Food and Drug Administration each have a 
role, and each has their own specialties, capabilities, and 
responsibilities in addressing biothreat preparedness and 
response. I remember well the complications of this 
interdependency from my time chairing the Homeland Security 
subcommittee with oversight of biodefense.
    Since my departure from that subcommittee, we have seen the 
GAO [Government Accountability Office] report that showed the 
Governmentwide biodefense enterprise as being fragmented and 
sometimes duplicative as well as lacking strategic oversight 
mechanisms. Now, this committee and the Congress have acted to 
ameliorate those concerns and enhance the interagency process. 
And I certainly look forward to hearing from our witnesses on 
what progress has been made and how far we still have to go.
    So, with that, Mr. Chairman, in the interest of time, I 
want to leave it there. I want to thank you again for convening 
the hearing. And I want to thank, obviously, our witnesses for 
appearing this morning. And I look forward to a very 
informative and interesting discussion.
    With that, I yield back.
    Mr. Thornberry. I thank the gentleman.
    And before going to our panel, I ask unanimous consent that 
other committee and non-committee members be allowed to 
participate in today's hearing after all subcommittee members 
have had a chance--have had the opportunity to ask questions. 
Is there
    Without objection, it is so ordered.
    Let me now turn to our witnesses.
    Thank you all for being here.
    We have--everybody is a doctor--Dr. Amy Smithson, Senior 
Fellow at the Monterey Institute of International Studies; Dr. 
Bruce Bennett, Senior Defense Analyst for RAND; retired Major 
General Dr. Philip Russell, who is a retired Army medical 
officer and professor emeritus at Johns Hopkins School of 
Public Health; and Dr. Brett Giroir, Interim Executive Vice 
President, Health Science Center, Texas A&M University.
    Again, thank you all for being here.
    Dr. Smithson, please proceed.


    Dr. Smithson. Good morning. And thank you for the 
opportunity to testify before the committee on matters of vital 
importance to the defense of this Nation.
    Mr. Thornberry. Dr. Smithson, if you would hit the 
microphone. And try to get it up kind of close to you. Some----
    Dr. Smithson. All right.
    Mr. Thornberry. They work better that way.
    Dr. Smithson. Sorry about that faulty start.
    Mr. Thornberry. Thank you.
    Dr. Smithson. I thank you for the opportunity to testify 
before the committee on matters of vital importance to the 
defense of this Nation.
    As you have already noted, the number of known biological 
weapons proliferators is relatively small today. I would add to 
that list North Korea, which I am sure Dr. Bennett will 
address. And over the past two decades, terrorists have wreaked 
havoc with bombs and bullets far more frequently than with 
disease. But no one should be complacent about the biological 
weapons threat.
    Regrettably, states and subnational actors alike can co-opt 
the fruits of the life sciences revolution for germs weapons 
programs, which are always shrouded in the utmost secrecy. 
Proliferators can use synthetic biology to create from scratch 
notorious killers like the 1918 influenza virus and even 
smallpox virus. And they can highjack other new life sciences 
technologies to manipulate and control human behavior.
    One of our other problems is that we don't know what we 
don't know. The intelligence community's performance assessing 
the biological weapons threat leaves a great deal to be 
desired. I will give you an idea why.
    Prior to the 1991 gulf war, U.S. intelligence did not 
identify Iraq's principal biological weapons production 
facility at Al Hakum, nor did they pick up on Iraq's purchase 
of an astounding 30 metric tons of growth media, which is used 
to grow biowarfare agents.
    Moreover, public health authorities, not law enforcement or 
intelligence officials, connected the dots in a 1984 surge in 
gastrointestinal illness in Oregon to the Rajneesh cult, which 
sickened 751 people when it decided to test its plot to foil an 
election by sprinkling salmonella on restaurant salad bars.
    U.S. intelligence agencies admitted in 1996 testimony that 
they were oblivious to Aum Shinrikyo's unconventional weapons 
programs until after the cult's infamous attack in the Tokyo 
subway on March 20th, 1995. Fortunately, Aum failed when it 
tried to acquire and disperse on several occasions biowarfare 
    And last but not least, the FBI [Federal Bureau of 
Investigation] turned to Dr. Bruce Ivins, a 26-year veteran of 
the U.S. Army Military Research Institute for Infectious 
Diseases, USAMRIID, to help them investigate the 2001 anthrax 
attacks, only fingering him as the culprit in 2008.
    Now, the Select Agent Rules, the centerpiece of the U.S. 
biosecurity approach, would not have stopped Bruce Ivins, who 
was mentally unstable and abusing drugs and alcohol. These 
rules do not require substance abuse screening, and they 
address mental health issues tangentially. Moreover, a 2001 
inventory of USAMRIID's culture collection turned up an amazing 
9,220 vials not listed in the facility's computerized 
inventory, including vials of botulinum neurotoxins and the 
Ebola virus. USAMRIID's inventory saga illustrates just how 
misapplied the paradigm of nuclear controls is in a life 
sciences world.
    With all of this in mind, I offer the committee three 
recommendations to consider.
    The concept and practice of biosecurity is in serious need 
of an overhaul, in part because evidence indicates that the 
Select Agent Rules have important opportunity costs for 
biodefense. Top scientists in laboratories have apparently 
opted out of work with high-risk pathogens already. Therefore, 
Congress should require the executive branch to prepare a cost-
benefit study of the Select Agent Rules and alternative 
approaches to biosecurity.
    Second, far, far too often, scientists' knowledge of 
important biosafety, biosecurity, and research oversight 
procedures falls to the inclinations and sometimes shoddy 
practices of their laboratory supervisor. No time should be 
wasted in correcting this ad hoc situation. Congress should 
consider how mandatory education and competency demonstration 
requirements could be instituted in all colleges and 
universities granting life sciences degrees in all institutions 
working with high-risk pathogens
    Third, the United States needs to go back to the drawing 
board on data-collection strategies, tactics, and tools that 
can be used to assess the biological weapons threat. Among 
other things, a congressionally mandated study would evaluate 
the limitations and prospective contributions of intelligence 
and inspections to the detection and deterrence of bioweapons 
    The United States Government appears to have done little to 
learn from the incredible experience of the United Nations 
Special Commission. With ordinary inspection tools and old-
fashioned, gumshoe detection work, UNSCOM [United Nations 
Special Commission] inspectors collected considerable evidence 
that Iraq was hiding a bioweapons program behind the facade of 
civilian activities. UNSCOM compelled Iraq to admit this.
    Inspections can work. And this experience stands as a 
direct challenge to the conventional wisdom that the Biological 
and Toxin Weapons Convention is inherently unverifiable. This 
study would be a springboard to identify alternatives to give 
U.S. policymakers more data of a more reliable quality about 
suspected biological weapons activities, which would, in turn, 
inform U.S. biodefense programs.
    With that, I would be pleased to answer any questions about 
my testimony.
    And I would also add a note of today's news that the OPCW, 
the Organization for the Prohibition of Chemical Weapons, has 
been awarded the Nobel Peace Prize. These inspectors are 
undertaking an unprecedented task, but for 17 years they have 
been going around the world monitoring the destruction of 
chemical weapons. And it is something that, perhaps, if you 
would also like to ask questions about the situation in Syria, 
I would be delighted to entertain them.
    Thank you for your time and attention.
    [The prepared statement of Dr. Smithson can be found in the 
Appendix on page 33.]
    Mr. Thornberry. Great. Thank you.
    Dr. Bennett.


    Dr. Bennett. Thank you very much, Chairman Thornberry, 
Ranking Member Langevin, and members of the subcommittee. Thank 
you for inviting me to testify at this hearing.
    While there are many evidences of the North Korean 
biological weapons, North Korea has been very effective at 
hiding that information, denying us information in the world 
about its biological weapons programs and making the threat 
very uncertain. Still, because biological weapons pose a 
fearsome threat, South Korea
and the United States need to be prepared, hedging against the
    I will discuss that threat and then turn to means for 
countering that threat, though I will focus on the nonmedical 
counters, given the expertise of my colleagues.
    In my written testimony, I have provided several open 
descriptions of the North Korean biological weapons program. To 
summarize, most observers believe that North Korea has pursued 
a serious biological weapons development program focused on a 
dozen diseases, to include anthrax, cholera, smallpox, and 
plague, the latter two being contagious diseases.
    It is not known whether these agents are currently 
weaponized, though there are a number of testimonies of North 
Korea testing these agents against people in its prison camps. 
Thus, even if these agents are not currently weaponized, the 
north should be able to weaponize them once it decides to 
prepare for war.
    North Korean special forces are a likely means of 
delivering biological weapons. The North has some 200,000 
special forces, some of whom could deliver devastating 
biological attacks against South Korea, Japan, and even the 
United States. Depending upon wind, atmospheric conditions, and 
population density, these forces could infect perhaps 500--or 
50,000 people per kilogram of anthrax used. Alternatively, with 
contagious diseases like smallpox, even if only 1,000 people 
were initially exposed, thousands more could be infected as the 
disease spreads.
    Biological effects are not limited to casualties and 
fatalities. As in the case of the anthrax letters, biological 
agents can deny the use of facilities, potentially for years. 
They can put overwhelming demands on the medical system. They 
can force people to use protective measures, measures that 
would particularly degrade military operations. They can cause 
psychological reactions like the 600,000 people who fled a city 
in India one night in 1994 after what turned out to be 167 
cases of plague.
    And how many cases of smallpox would have to be brought 
back into the United States, for example, among evacuated 
noncombatants, combat casualties, or aircrews, before the 
United States would face substantial economic and psychological 
    So how can we prepare for and respond to these potential 
attacks? We must prepare to counter the effects of biological 
attacks. Such capabilities would also help deter the attacks in 
the first place, and deterrence is clearly the preferred 
option. As noted above, I will focus here on the useful 
nonmedical counters.
    In peacetime, North Korean special forces seeking to 
covertly introduce biological weapons for future attacks could 
be stopped at South Korean or U.S. borders if immigration was 
connected to the passport databases of Asian countries and able 
to detect falsified passports. In crisis and conflict, the U.S. 
and South Korea could use robust air and missile defenses if 
they are deployed in Korea against North Korean military 
aircraft or missiles that might carry biological weapons.
    With contagious diseases, exposure can be prevented in 
various nonmedical ways. Schools can be closed, public 
activities suspended, those sick can be physically isolated, 
and those exposed could be subjected to quarantine if the laws 
exist to facilitate these arrangements.
    People arriving at international air and sea ports should 
be scanned for a fever. Those with fever should be isolated 
until their fever subsides or testing determines they are not 
contagious. This procedure continues in South Korea, for 
    The United States and South Korea should buy respirators 
now that they would use to block disease should there be an 
outbreak of biological agents. And collective protection should 
be provided with us building military facilities in Korea now 
at Camp Humphreys, as they were provided when we built those 
facilities--similar facilities at Osan Air Base.
    In conclusion, the North Korean biological weapons pose 
potentially serious though uncertain threats to South Korea and 
to the United States. This threat should press the United 
States and South Korea to pursue more complete protections.
    Thank you.
    [The prepared statement of Dr. Bennett can be found in the 
Appendix on page 42.]
    Mr. Thornberry. Thank you.
    General Russell.


    General Russell. Thank you, Mr. Chairman, members of the 
committee. I appreciate the opportunity to discuss an issue 
that has been--I have been concerned about for about 35 years 
or more. And I would like to present my views on what I believe 
is a significant unaddressed threat to our Armed Forces and to 
our national security.
    Over the past two years, my colleagues Mr. Joel McCleary 
and Dr. Keith Wells and I have conducted a study of the 
impressive achievements of the U.S. offensive biowarfare 
program to learn what that means in terms of modern threat 
assessment. We conducted a parallel study of how advancement in 
pharmaceutical manufacturing can benefit and enable our 
adversaries. Our study of the offensive program was based on 
existing unclassified documents and on the oral history of one 
of the scientific leaders of the program, Mr. Bill Patrick. A 
parallel study of classified materials by Dr. Robert Kadlec 
supported our findings.
    The U.S. offensive biowarfare program was very large, very 
well-funded, and very successful. By 1969, when the program was 
terminated, it had achieved the ability to deliver lethal and 
incapacitating agents in a dry powder aerosol over very large 
areas, up to hundreds of square miles. The effectiveness of the 
program was conclusively demonstrated in large-scale field 
tests such as Red Cloud, Watch Dog, and Speckled Start. These 
were enormous trials, many of them conducted over the Pacific.
    The two agents chosen by the program after years of 
research to be the most effective were tularemia and 
staphylococcal enterotoxin B, or SEB. Tularemia is one of the 
most infectious agents known and, when delivered by aerosol in 
high doses, causes a severe respiratory disease that can be 
fatal. Tularemia is widely disseminated in nature and easily 
obtained. SEB causes rapid incapacitation and is also lethal in 
high concentrations.
    These agents, along with delivery systems, were 
manufactured and stockpiled. There were plans to use them in 
combination, one for rapid effect and one for lethality. Both 
of these agents are readily available to anybody who can 
isolate a bacterium.
    Very few of our present Government officials understand the 
achievements of that program and what it means to our current 
security. Our analysis of the advances in biologic 
manufacturing technology and bioprocessing leads to the 
conclusion that it is now possible for a small group of 
adversaries to produce these same weapons in quantities large 
enough for a strategic attack. Advances in aerosol delivery of 
therapeutics have provided our adversaries with greatly 
enhanced capability.
    We now have no specific licensed preventive medical 
countermeasures for these two agents. We rely on antibiotic 
therapy for tularemia and supportive care for SEB. The 
deficiencies in our national medical countermeasures 
development programs have been very well documented. The 
Department of Defense created a joint program for advanced 
development of medical countermeasures for biodefense in 1996. 
The joint vaccine acquisition programs, I think started in 
1997, was a major component of this.
    A tularemia vaccine was at the top of the requirements 
list, which included several other biodefense vaccines 
against--most of them up against viruses. It is now 17 years 
later and no new licensed products have been developed.
    Several independent reviews of the DOD programs, including 
one directed by Congress and two by the Institute of Medicine, 
were highly critical of the management of the program. To my 
knowledge, the recommendations of outside panels have been 
    In summary, I believe that a significant national 
vulnerability exists that will persist unless action is taken 
to improve our countermeasures development efforts.
    I thank you for your attention to this issue. I will be 
happy to answer questions.
    [The prepared statement of General Russell can be found in 
the Appendix on page 61.]
    Mr. Thornberry. Thank you.
    Dr. Giroir.


    Dr. Giroir. Chairman Thornberry, Ranking Member Langevin, 
members of the committee, Congressman Flores, thank you for the 
opportunity to be here today.
    I am here as the principal investigator for the Texas A&M 
Center for Innovation in Advanced Development and 
Manufacturing, a public-private partnership with the Biomedical 
Advanced Research and Development Authority, also known as 
BARDA, of the U.S. Department of Health and Human Services. 
This partnership is designed to enhance the Nation's 
preparedness against pandemic influenza as well as chemical, 
biological, radiological, and nuclear threats.
    My previous experience includes Government service as the 
director of DARPA's [Defense Advanced Research Projects Agency] 
science office and also as chair of the Chemical and Biological 
Defense Panel of the Threat Reduction Advisory Committee at 
Defense Threat Reduction Agency (DTRA).
    At DARPA, we identified a critical national need for core 
biomanufacturing facilities that would be low-cost, flexible, 
adaptable, capable of simultaneously producing multiple 
products to support biodefense, while maintaining the ability 
to surge to a single product during a national emergency. In 
2008, when my assignment at DARPA was completed, I joined the 
Texas A&M system, secured a $50 million investment from the 
State of Texas to demonstrate those flexible manufacturing 
capabilities originally envisioned at DARPA.
    Beginning in 2009, Texas A&M designed, developed, 
constructed, and is now operating a revolutionary first-in-
class, 150,000-square-foot facility that has pioneered highly 
flexible, adaptable, and even mobile manufacturing platforms at 
a capital cost of about 80 percent less than the current state 
of the art. This project, called the National Center for 
Therapeutics Manufacturing, is a primary infrastructure asset 
for the HHS [U.S. Department of Health and Human Services] 
center, which I will now describe.
    The Texas A&M Center for Innovation is one of three 
national centers competitively awarded by HHS in June of 2012 
and is the only one led by an academic institution. It is found 
on an initial 5\1/2\-year base period contract consisting of 
$176 million in funding from HHS and a $109 million cost-share 
by our center's academic, commercial, and State of Texas 
partners. The total potential duration of the contract is 25 
years, with options for an additional $2.4 billion in readiness 
stipends and task orders.
    The high-level objectives of our center are: first, to 
provide a national vaccine response against pandemic influenza, 
defined as 50 million doses delivered in 4 months, with initial 
doses available to the U.S. Government in 12 weeks; second, to 
perform what is called the advanced development and 
manufacturing of vaccines and medical countermeasures against 
chemical, biological, radiological, and nuclear threats as 
tasked by HHS; and, third, and very importantly, to train the 
future domestic U.S. workforce.
    To achieve these objectives, Texas A&M is leading a 
multidisciplinary team with expertise spanning from research 
through clinical trials, including GlaxoSmithKline, or GSK, 
Vaccines, the world's largest vaccine developer, with over 1.4 
billion vaccine doses distributed worldwide annually and 11 
vaccines in the United States.
    The center is also actively expanding domestic U.S. 
infrastructure. First, our preexisting facility is undergoing a 
capabilities upgrade that will be completed in March of 2014. 
Second, we are building a new, dedicated pandemic influenza 
vaccine facility to meet our 50-million-dose requirements. 
Construction and facility commissioning will be completed in 
the third quarter of 2015. Third, we are building a new live-
virus vaccine facility to produce vaccines up to the BSL-3 
biosafety level. Construction and facility commissioning will 
also be completed in the third quarter of 2015.
    I would like to finish my remarks highlighting 
opportunities for collaboration with the Department of Defense.
    First, Texas A&M is highly motivated to continue our 
distinguished history of service to the Nation by supporting 
the DOD and supplying improved vaccines and countermeasures to 
the warfighter. Of particular interest would be DOD 
partnerships to develop and manufacture products for their 
stockpile and special immunizations programs and, perhaps more 
importantly, to be the cornerstone for an emergency response to 
genetically modified, or chimeric organisms as well as other 
unexpected agents that we believe are a growing real threat to 
our national security and public health.
    According to our contract with HHS, at least 50 percent of 
our center's capabilities are available for non-HHS projects. 
Therefore, there is an immediate opportunity for the DOD to 
utilize our center's capacity and expertise, which has already 
been funded by HHS. We believe such collaborations would not 
only reduce DOD operational risks but would also reduce DOD 
expenditures, potentially by hundreds of millions of dollars 
that could then be reallocated to provide additional vaccines, 
countermeasures, and capabilities to our warfighters.
    Thank you very much for this opportunity, and I am pleased 
to answer any questions.
    [The prepared statement of Dr. Giroir can be found in the 
Appendix on page 65.]
    Mr. Thornberry. Thank you.
    And, without objection, you all's full written statement 
will be made part of the record as well, but I appreciate the 
oral comments from each of you.
    Let me just begin with one question that I would invite 
each of you to address, and that is referencing back to the 
paper I mentioned on terrorists' use of biological weapons.
    And I would just--you all were not asked to testify as 
experts on terrorism, but I would be interested in whatever 
thoughts you may have about the likelihood of such a thing, 
what some of the challenges would be, you know, whatever you 
feel comfortable in commenting on a terrorist attack using 
these sorts of weapons.
    Dr. Smithson.
    Dr. Smithson. I have looked at the statistics of terrorist 
activity, and it is clear that, for the time being at least, 
they are far more interested in bombs and bullets over the past 
couple of decades. But it is also equally clear, by the 
attempts to acquire substances and the uncovering of plots, 
that there is increasing interest among terrorists.
    The other thing that I think brings this within the reach 
of not just terrorist groups but individuals is the de-skilling 
of equipment. In other words, things that used to take Soviet 
bioweaponeers thousands and thousands of man-hours can now be 
accomplished by a piece of equipment in a fairly short time. 
They are currently working on desktop printers for DNA 
[Deoxyribonucleic Acid ].
    So it is a very fast-moving technical situation that will 
allow terrorist groups to acquire this capability. And we know 
that there are terrorist groups out there, like al Qaeda, that 
have the intent to kill indiscriminately.
    So I am very concerned about the prospects for the future. 
I don't know exactly when, but I do believe we will see 
bioterrorism again.
    And in my prepared remarks, I quote another individual who 
agrees with this study cited, and it is Martin Shubik, who 
views this situation in an equally grave manner.
    Dr. Bennett. I think we have to face the fact that some of 
the state actors we look at look a lot like terrorists when 
they actually go out. Some of my colleagues in the South Korean 
military believe that they have been subjected to testing by 
the North Korean special forces in recent years. Anthrax, 
probably several other diseases, they believe, have been tested 
in their territory to see what kind of reaction there would be 
and the ability to cope. That is clearly a terrorist kind of 
    I think we also have to recognize that some of these state 
actors are very closely tied to Iran, to Syria, where you have 
the potential for state-sponsored terrorists and would be quite 
pleased to see terrorists also using these capabilities and 
have done a fair amount of transferring of technology and 
capability to other states. We don't know about to specific 
terrorist groups, but you have to wonder if that isn't coming, 
if it hasn't already occurred.
    General Russell. Unfortunately, some of the best potential 
bioweapons exist in nature and are readily available, so 
locking up bacteria and viruses is not going to solve the 
    The advances in biologic manufacturing that I mentioned 
include the drying methodologies and production of aerosol 
powders. This information is widely available on the Internet. 
The equipment is for sale on the Internet. I think we have seen 
a tremendous shift of advantage to the adversaries in this 
regard because of the ability of a very small group of people 
with the expertise to manufacture these weapons. And the 
weapons are very, very dangerous.
    Dr. Giroir. I certainly share the other witnesses' 
    And I will reemphasize what Dr. Smithson said, is I believe 
the barrier to entry into this has dramatically decreased, both 
because of the biomanufacturing advances that General Russell 
has said but also the ubiquitous nature of DNA technology, 
recombinant DNA technology, synthetic DNA technology. 
Literally, what took me weeks during medical school to produce 
in a multimillion-dollar laboratory can be done in an afternoon 
on a benchtop by someone with a relatively less degree of 
scientific training. So the barriers to entry have decreased.
    I share General Russell's concern about the known threats. 
As a critical care physician, I have treated both SEB and 
tularemia, and the thought of having hundreds or thousands of 
such patients cannot even be comprehended by the medical 
community, much less addressed.
    And, third, I share the concern about some of your remarks, 
sir, about masked or chimeric organisms that I think leverage 
current vaccine technologies that are developed for the 
betterment of mankind. These are very, very concerned to mask 
very dangerous organisms within infectious aerosol organisms.
    So, again, I share the threat and wanted to re-echo some of 
their themes.
    Mr. Thornberry. Mr. Langevin.
    Mr. Langevin. Thank you, Mr. Chairman.
    Again, thanks to our panel. This is obviously a very 
sobering discussion. And I am reminded that there are obviously 
many threats that we face, particularly from terrorism, and as 
horrific as a nuclear attack on the country would be, 
thankfully Mother Nature didn't make it easy to make weapons-
grade plutonium or highly enriched uranium. However, developing 
bioweapons and using them against our population is something 
that terrorists could do not just once but again and again and 
again, and it poses great risk.
    This is something, as I mentioned in my opening statement, 
I spent quite a bit of time on when I chaired the Subcommittee 
on Emerging Threats, a subcommittee on Homeland Security.
    And I would like to just start by asking your concerns 
about what are the more likely pathogens that we have to worry 
about. I know we talked about tularemia. Would you put that as 
number one on the list? Or is it weaponized aerosolized 
anthrax? Where should we be targeting our resources to develop 
    These are obviously important discussions for us to 
contemplate. And it is also important to remember that people 
would be kidding themselves or grossly misinformed if they 
thought that terrorists and the various groups and forms that 
they take are uneducated. These are actually highly educated 
people, in many ways, in the STEM [Science, Technology, 
Engineering, and Mathematics] fields, in the biosciences. And 
this issue of threat of bioweapons attack on the country is 
something that, it is one of those things that does keep me up 
late at night.
    But I would like to talk about, in terms of prioritization, 
what do you think are highest on the list? We can go right down 
the line.
    Dr. Smithson. Thank you, Congressman. And I am afraid my 
answer may disappoint you somewhat.
    Yes, everything on the list is a problem, but so are things 
that aren't on the list. And this is one of the things that I 
learned from the inspectors of the United Nations Special 
Commission. We tend to look at these problems through the lens 
of our past program and of what we know about other past state-
level programs. And then along comes a country like Iraq, and 
they choose to weaponize an agent that causes liver cancer and 
something that causes gas
    So when you go in looking for something that you expect--
and I guess my message in this case is that things that are not 
on the list could be very problematic. They can be genetically 
engineered to increase their lethality and contagiousness. We 
know that the Russians did a lot of this work. I have been in 
over 20 of the facilities that were part of the former Soviet 
    So, in considering what is a problem, I know we have to 
prioritize, but I would encourage everyone to keep in mind that 
it is not just about a list. It is about a world of potential 
    Thank you.
    Dr. Bennett. I think we have to recognize the fact that it 
depends upon what the target is. If someone is trying to attack 
the civil population, which could happen in this country, they 
can use almost any of the agents. Whatever is easiest to 
produce could cause the effects.
    If they are trying to go after our military, and we are 
properly vaccinated in certain areas, they are going to go 
after things that are different. And their knowledge, which is 
pretty well-established on what kind of protections we have 
fielded, will lead them to some differences. But those 
differences, as Amy has just said, are pretty easy to come by. 
There are lots of alternatives out there.
    General Russell. I have a slightly different view of that 
because if you look at the characteristics of biologic agents, 
microbial agents, and their suitability for use of weapons, 
there is a hierarchy. Some are easily manufactured. The 
bacteria are much more easily manufactured than viruses, for 
example. It takes a lot of expertise to grow viruses in cell 
culture. Bacteria are easy. The stability of the organism, both 
in growth and in aerosol, is a huge issue and one that was 
solved by the two programs. And the availability, I do not have 
a high level of concern about chimeric agents, about engineered 
agents, simply because Mother Nature is a much better 
bioengineer than anybody has published so far. But there is a 
    Tularemia came to the top of the list from the two 
offensive programs. Anthrax is ten-thousand-fold less 
infectious, but it is a persistent agent and it is very, very 
dangerous. But there is a hierarchy. I think we have a pretty 
good posture in terms of smallpox, a pretty good posture in 
terms of anthrax, but I think we have a couple more on the list 
that we need to take off as major concerns. And then we can 
worry about downstream engineered organisms.
    Dr. Giroir. I certainly agree that the likely existential 
threats, such as smallpox, likelihood of anthrax, et cetera, 
need to be taken off the table very early.
    I don't share the opinion that the genetically modified or 
chimeric organisms are lower down the list. And I think that is 
based on good information about what is capable and what was 
thought of. That is not to say that nature doesn't always throw 
something at you naturally; I completely agree with you. But I 
do believe that the genetic modifications and chimeric 
organisms are an important threat.
    The last thing I would say is a prioritization on the list 
needs to be the unknown unknown, what were not expected for. 
And we, at least I believe, nationally need to take a lot of 
lessons from the DOD in exercising the capability and doing 
tests and exercises that, if we see something we don't know of, 
how does this actually happen? How does my center interact with 
other centers? How does the DOD interact with HHS? How do we do 
it and distribute it in a very short timeframe? Which is a very 
different problem than taking 10 years to make your next 
anthrax product and stockpiling it.
    Mr. Langevin. Thank you, Mr. Chairman.
    Mr. Thornberry. Mr. Nugent.
    Mr. Nugent. Thank you, Mr. Chairman.
    And I want to thank this panel. I don't feel very 
comfortable. Thank you so very much in doing that.
    And, particularly, you know, there was a GAO report out in 
regards to biodefense efforts being somewhat fragmented. And, 
obviously, there are a lot of different takes on what we should 
address and what we should look at, so that makes it even more 
difficult, I am sure.
    I would love to hear your input in regards to what you 
think--I mean, there has been some legislative, I guess, tries 
to fix, but what do you think we need to do to try to 
coordinate and use best practices or--you know, when we are 
spending money, let's get the best bang for our buck.
    Dr.--right? Doctor, doctor, doctor, but Dr. Smithson.
    Dr. Smithson. Apologies. A group like us does tend to be, 
shall we say, the skunk at the cocktail party. But we are all 
here in the service of defense and peace.
    I think the coordination of a government as large and 
unwieldy as ours is a never-ending challenge. And the only 
surefire way to ensure that more, as opposed to less, of that 
happens is to have White House attention and dedicated 
responsibility on issues just like this and to have, quite 
frankly, the whip cracked from that location frequently in 
terms of oversight and coordination.
    Otherwise, I think there are organizations and even 
scientists that have their own preferred solutions, and you 
don't get too much of an agreed agenda. And so, yeah, I would 
put a strong vote for more attention from the White House.
    Mr. Nugent. Dr. Bennett.
    Dr. Bennett. I think what we have to recognize--I think the 
medical responses are extraordinarily important, but there are 
a lot of nonmedical responses that also have to be coordinated 
in here. Our legal framework for doing things like quarantine 
and isolation is not really there.
    In the 1970s, when you had the outbreak of smallpox in 
Yugoslavia, they forcefully vaccinated almost 90 percent of the 
population, even though it was already vaccinated, to try and 
get it under control. They threw over 10,000 people into 
quarantine for several weeks. They took very extreme measures.
    Now, they got it under control relatively quickly as a 
result, but it was a combination of the medical and the 
nonmedical actions. And, as Amy has suggested, somebody needs 
to be looking at that combination and making sure we have the 
full package of tools so that we can proceed.
    Mr. Nugent. General.
    General Russell. In our Government, everybody is in favor 
of coordination, but nobody wants to be coordinated. It is a 
very, very difficult issue, one I struggled with when I was in 
the Army, when I was at HHS.
    And the fundamental answer is senior leadership and 
direction. If there is strong central senior leadership, the 
agencies will respond and work together. If there is not, they 
will not; they will go their own way. And there is a lot of 
history to support that view.
    And Dr. Bennett has it absolutely correct, medical 
countermeasures are only a piece of the issue. We need a focus 
on biologic terrorism and the threat, and we need a coordinated 
across-the-Government effort to do it, but that takes 
centralized leadership to do it.
    Mr. Nugent. Doctor.
    Dr. Giroir. I am going to echo, centralized leadership is 
key. I think some structures have been made in the last few 
years that are very positive. The so-called PHEMCE, the Public 
Health Emergency Medical Countermeasures Enterprise, where 
everyone is at the table--DOD, DHHS, FDA [Food and Drug 
Administration], NIH [National Institutes of Health], et 
cetera--I think that is very, very positive. It is done at a 
high level, Assistant Secretary, then at a level below that 
where the work gets done.
    But, again, everyone around the table. There is no 
substitute by having someone calling the leadership of that 
group and helping people who may not want to be coordinated to 
be coordinated.
    I only give you my experience when I was at DARPA. The day 
that Dr. Kadlec took a special assistant to the president 
position, in terms of biosecurity, the world changed 
instantaneously, because everyone was around the table and 
someone told us all what was expected of us and held us 
accountable to that. And I thought that was a very important 
lesson that I learned.
    Mr. Nugent. Seems like a key theme across the board, 
though, is about leadership from the top.
    Thank you so very much.
    I yield back.
    Mr. Thornberry. Mrs. Davis.
    Mrs. Davis. Thank you, Mr. Chairman.
    And I am glad we are having the interagency discussion. And 
as I know the chairman knows, it has been an issue, of course, 
on the Armed Services Committee.
    I actually recall that when I first came to Congress, NDU, 
National Defense University, did a lot of those simulations. 
And, you know, we had one biological attack and, you know, 
another week came over, and you see the map and the changes. 
And it is actually something that is not being done anymore, I 
don't believe. And I thought it was educational. It was scary, 
but it did give us a sense.
    And having everybody around the table, the difficulty, as 
you say, is, where does the leadership come from, and how do we 
actually move forward with that? You have all basically talked 
a little bit about that. You see that in the executive branch. 
Could you help us understand? I mean, how often do you think 
these issues come up? How prevalent is--you know, how much a 
part of the discussions do we have biowarfare?
    And, also, in terms of public-private partnerships, Dr. 
Giroir, you were talking about Texas A&M and the fact that, in 
terms of research and development, you are kind of asking the 
question, is there something more that could be done? DARPA led 
some of those efforts, but then it moves over to the private 
sector or at least the academic sector.
    How do you see that working better together? Are there 
authorities that are needed? Is there something else that 
perhaps Congress should be doing to facilitate that? How good 
an idea is that? And are we putting our efforts into R&D 
[Research and Development], and whether it is DARPA or ARPA, 
whatever, that should be more focused in this regard, 
preventative as well as the others?
    Dr. Smithson. Thank you for your question.
    As somebody who has specialized in chemical and biological 
weapons nonproliferation for over two decades, I can tell you 
that it can be a lonely place in a very nuclear, nuclear-
centric world.
    Look, it is understandable that decisionmakers and think 
tanks and everybody else worries perhaps first and foremost 
about these things. And I think if there is something positive 
to be taken out of the anthrax letter attacks in 2001, it is 
that biological is now part of that conversation more 
frequently. It is on people's minds.
    But it is an incredibly complicated thing to parse. 
Sometimes what you do that has a benefit in one instance--for 
example, increasing the disease surveillance capacities of 
overseas laboratories so that they can detect an outbreak 
before it reaches U.S. shores--might also have a downside if 
you don't properly train those laboratory technicians in the 
biosafety precautions they need and must have. And if they 
don't have a concept of security and responsibility for the 
work that they do--they are not even aware, often, that agents 
have been weaponized and even used in war in this field.
    So it is a very complicated situation to get decisionmakers 
to focus on. And sometimes, quite frankly, they just throw up 
their hands, ``What are we to do,'' in these circumstances.
    Get more people like us in the room with you more 
frequently. And if you would like another thrilling scenario 
exercise, I can provide one of those, in terms of even the 
challenges of attributing a biological weapons attack, which is 
the first part of a response.
    Dr. Bennett. Let me give you an example along the lines you 
are talking about. Let's say that there is a collapse of the 
North Korean Government, that some of the factions decide that 
they are going to use some of the smallpox, which they may well 
have, and they simply sprinkle it among the American 
communities in Seoul.
    But, of course, in that kind of situation, we would want to 
evacuate the noncombatants, because a civil war might break out 
in the North and difficult situation develop, and we evacuate 
them back to the United States. And, of course, smallpox takes 
12, 15, 20 days to develop. Those people come back to the 
United States and you get the disease once they are back here, 
and it is already spreading. So where is our concept for 
quarantine of those people we would be evacuating out if there 
really is a risk?
    Part of the problem is we need to be discussing these 
things more to recognize where those vulnerabilities are. Those 
discussions, I don't see them going on. And I think that is the 
kind of thing, exactly as you suggest, where we need to raise 
the consciousness in order to address it.
    General Russell. The biologists are a minority in the--in 
this discussion. Most of the discussion is so dominated by the 
nuclear and the chemical communities, that the--and the 
leadership thinks along the lines that they are used to dealing 
with those threats, and they are so very, very different from 
the biologic threat, that the medical countermeasure 
development has always struggled because to a large extent, the 
leadership in the Department of Defense doesn't understand the 
vaccine industry, doesn't understand the biology, and it 
doesn't understand the science.
    That expertise has been largely developed and stayed within 
the medical departments of the armed services, but the Defense 
Department is quite separate from that and has not benefited 
from the transfer of that information. I hope that things will 
change in the future, because we do have a really major 
    Dr. Giroir. Just want to make a comment or two about the 
coordination, and there is an analogous side on the DOD, but I 
will stick to DHHS since I am now one of the centers. I think 
it is important to understand how things link. The National 
Institutes of Health, particularly NIAID [National Institute of 
Allergy and Infectious Diseases], is responsible for doing the 
basic work that sets the groundwork for all the countermeasures 
in vaccines that are actually done. They bring it to a certain 
level, either late preclinical, or what is called phase one, 
and then it is transitioned to BARDA, the Biomedical Advanced 
Research and Development Authority, to do what is called 
advanced development in manufacturing, the scale-up, the 
readiness. This is very, very expensive; the later stage 
clinical trials to bring them.
    So the first set of coordination is within the agencies 
themselves. And personally I am seeing that being very 
positive, that the NIH and BARDA are working very closely 
together. People like me from the academic community on the 
advanced development side are being invited to all the critical 
meetings on the NIH side, so we know what is coming down the 
pike back and forth. So I just wanted to make that kind of 
clear about how this works. And there is an analogous situation 
on the DOD side between basic research and acquisition.
    Two things you asked for specific suggestions, so I will 
give them to you. At least on the advanced development side, it 
is critical to have commercial partnerships in this venture, 
because the expertise, the critical mass, the knowledge 
primarily resides in large or even medium companies who do this 
for a living every day, and in order to be cost-effective but 
also reduce the risk, we have got to bring commercial partners. 
Again, this was a major effort of BARDA, and we brought in GSK, 
who is working with us primarily on pandemic influenza.
    I think anything that could be done to incentivize 
commercial pharma to get in this area, which is not profitable 
and is of high risk, would benefit us very much. And I think 
one thing that can be done is ease of Government contracting 
and lack of administrative burden imposed on companies who, 
quite frankly, don't have the time, willingness or ability to 
take that risk that Government contracts put on them.
    The third thing I would say is I would have Congress 
encourage agencies like BARDA on the contracting side to use 
the flexible authorities that they were given to expedite 
contracts and make them more goal-oriented except--instead of 
cost-based contracts where basically every nut or bolt has to 
be justified and there is a margin put on that. I think the 
contracting authority that was given is plenty sufficient, but 
it needs to be exercised in a more rigorous way. If you ask me 
what I think you could do, I would have Congress encourage them 
to use the authorities that were already given. And maybe 
General Russell disagrees with that, but----
    General Russell. I do not.
    Dr. Giroir. Okay.
    General Russell. I heartily agree with that.
    Mr. Thornberry. Well, that is a story we have heard in 
other places, as you can imagine. Federal contracting is one of 
our biggest problems. And I remember some of those exercises 
you were talking about dealing with anthrax, for example, which 
got to be in my part of Texas, and it just shut down the 
country once you start quarantining places off. It really does 
open your eye. We have got our own doctor, Dr. Heck.
    Dr. Heck. Thank you, Mr. Chairman. Thank you all for that 
excellent review of where we are at and the discussions of the 
needs for physical and medical countermeasures and the 
importance of addressing the genetic and chimeric organisms, 
but I think, in my mind, Dr. Bennett hit it on the head, which 
our underlying issue is the lack of discussions and how are we 
going to address the issues that we face? I remember in 1997 
when then-Secretary of Defense Bill Cohen was on ABC's ``This 
Week'' and held up the 5-pound bag of sugar and said, if this 
was anthrax and spread over D.C., it would take out half the 
    So we are about 16 years later and still waiting for 
meaningful discussions to take place. And while the things that 
you talked about are important, critically important, I think 
there are a lot of other simpler things that we have yet to 
talk about, like the identification of dual-use technology and 
how we are going to figure out if what they are doing is for 
licit purposes or illicit purposes.
    The chronic underfunding of public health infrastructure in 
this Nation, who actually will be the first responders, as Dr. 
Smithson pointed out, was the group that figured out what was 
going on in The Dalles, Oregon, salmonella outbreak.
    And, of course, Dr. Giroir, you mentioned the overwhelming 
of our healthcare system by mass casualties. And you look at 
the statistics that in most mass incidents, it is about a 
seven-to-one ratio of those who are actually affected versus 
those who are unaffected but show up just because--I am an 
emergency medicine doc--just because they want to get checked, 
and they are concerned, the psychological fears.
    So how would you address those things? Dual use; figuring 
out who is good, who is bad; the chronic underfunding of public 
health, or how do we enforce public health infrastructure; and 
how are we going to prepare our healthcare system to deal with 
the casualties?
    Dr. Smithson. I always love a simple question. Thanks for 
that. I could not agree with you more that investment in public 
health is always a sound idea. And in this case, it doesn't 
necessarily matter, in terms of casualty care, whether it is 
Mother Nature or a deliberate attack, so that is always a good 
    In terms of identifying dual-use technology, this is 
something that concerns me greatly, because of how quickly 
this--the equipment and knowledge is--is advancing at this very 
time. And there are tools like the Australia Group, which was 
formed in the mid 1980s in response to the attempts of Iran and 
Iraq to acquire chemical weapons precursors from a variety of 
supplier nations, and so we began to harmonize our export 
controls. And that group now also addresses biological 
materials and dual-use biological equipment, but it is tough 
for the Government to agree how to address some of these 
issues, in part, because there are so many things happening, 
and there are so many different opinions about what is most 
    So here is what I would encourage us to do, and that is 
actually to get industry into that equation as well, because 
there are some very constructive things that can be done in 
terms of public-private partnerships with regard to control of 
dual-use equipment. Name me a company that wants to have its 
piece of equipment end up on the front page of The New York 
Times or some other media outlet as being part of a terrorist 
attack or a state-level biological weapons program. So we need 
to work with industry to provide them with some access to the 
information that we collect and get their cooperation in terms 
of screening customers more effectively than perhaps even the 
Government can accomplish.
    Dr. Bennett. Let me turn to the military in particular and 
some things we could be asking the military to do. I think we 
need to recognize the fact that this kind of threat could 
overplay any kind of future contingency, whether it is a 
challenge like a provocation in North Korea or some major 
conflict. So do we ask all of our soldiers that are deployed in 
the field to report in as soon as they are sick with any kind 
of virus or whatever? Most of them are typical military 
personnel. They are a little reluctant to do that until they 
are sure they are really sick, just like many of us are. Rules 
on that kind of thing could be very important.
    Similarly, let's think about the military. If we can't 
evacuate casualties from the theater, our current concepts for 
military medical care are very much challenged. We may have to 
plan to do much more medical care in a theater in order to take 
care of our personnel who have become casualties, conventional 
casualties, if there is the threat of contagious disease coming 
back with them. So this is all a matter of starting to think in 
this context of if this really is a threat, let's take it 
    General Russell. Shortly after 9/11 and the anthrax 
attacks, there was a huge investment in the public health 
infrastructure of this country. A lot of manpower was added and 
a lot of capability, both for surveillance and for first 
response. I believe that that has seriously deteriorated over 
the succeeding years, and our public health infrastructure, I 
think, needs a lot of attention.
    One of the operational aspects of military medicine has 
been the overseas laboratories of the armed services, and they 
have provided both an enormously effective base for research in 
the epidemiology of infectious diseases in various parts of the 
world, and they are also good listening posts. They interact 
with the medical and public health communities of their 
countries. And I think that one thing we could do to improve 
our ability to understand what is going on in the rest of the 
world in terms of infectious diseases is to increase our 
investment in the overseas laboratories.
    Both the Army and the Navy have very good labs that have in 
recent years not been very well supported.
    Dr. Giroir. I am in the enviable position to be last, so I 
can agree a lot, but the public health system will likely be 
tasked to handle such an outbreak. I think it is also very 
likely that it will be the first detectors of an outbreak, the 
first responders, the emergency room physicians, the infectious 
disease physicians, so any investment into public health is an 
investment in national security in this regard, and I feel that 
very, very strongly.
    I also agree that industry involvement is very important in 
this, both from the dual-use technologies, to bring them 
onboard and help solve the problem, and as the dual-use 
technologies do proliferate, I think it is important to 
understand that they are all computer-based technologies, 
digital-based technologies, so quite aside from what we are 
talking about, I would hope that the intelligence communities 
have avenues into collaboration with biologists to understand 
what those signals can be, which may be very, very rich.
    I do want to say that as hard as all this is, and as much 
as we are sort of laying crate today, I think these are all 
tractable problems. These are all solvable problems if there is 
coordination and leadership. There is not--as a critical care 
and ER [Emergency Room] doctor, there is not a day in the 
winter that you don't have 100 patients more than you deal 
with--that you can deal with comfortably. So people on the 
front lines, whether it be military or health responders, know 
how to handle this problem, but they need some help, they need 
some coordination, they need to be involved and educated to 
help solve this problem. And it is solvable. These are solvable 
problems. They may not be 100-percent solvable, but 80- or 90-
percent solvable is a whole lot better than where we are right 
    Dr. Heck. Thank you. Thank you, Mr. Chairman.
    Mr. Thornberry. Mrs. Hartzler.
    Mrs. Hartzler. Thank you, Mr. Chair. This has been very 
enlightening and disturbing all at the same time, but it is 
good that we are starting--not starting the discussion, but 
bringing it up today. But I wanted to go back to part of your 
testimony, Dr. Smithson, about Syria, and we haven't really 
touched on that. Could you give us an update on what is really 
taking place there and how likely you believe will be the 
ultimate success, will we be able to identify and access all of 
the different chemical sites, will we be able to do away with 
these weapons? Can you give us an
    Dr. Smithson. Thank you. And I think we have got a 
tremendous challenge on our hands with Syria, in part because 
of Bashar al Assad's track record with regard to cooperation 
with nuclear inspectors. If you will recall, in 2007--or 2006, 
Israel bombed a nuclear reactor there, which the Syrian 
government built in secret, but they were a member of the 
Nuclear Non-Proliferation Treaty since 1968. And after they 
built this place, they tried to disguise it with an outer 
building that didn't make it look like a nuclear reactor. And 
after it was bombed, they immediately cleaned up the site and 
then delayed the inspectors from getting in there. And even 
when they found evidence of manmade uranium, they simply 
pointed to that as the fault of the Israelis who bombed the 
site and said it was part of the bomb particles.
    The track record in collaborating with the chemical 
inspectors, yes, we have all seen the footage of the chemical 
inspectors inside a facility, and methinks perhaps he is 
really, really trying to persuade us that he is going to 
cooperate, but keep in mind that already he has shot at the 
chemical investigators that Secretary General Ban Ki-moon sent 
in there, he tried to bomb away the evidence of the attacks of 
August 21st. It is a very mixed track record.
    And it is an incredibly difficult thing that they are going 
to attempt to do. I am not confident that U.S. intelligence or 
any other intelligence has identified all of the sites involved 
in this program. And I am very appreciative that the Defense 
Department has assets, as do the Russians, which can be brought 
into this equation to hydrolyze and degrade the agent if it is 
stored in bulk quantities, as well as to literally blow up in 
boom boxes in a contained situation munitions.
    Getting there is going to be tough, because if you have got 
to try to move these things, oh, my gosh. Think about the 
security environment: Hezbollah, Hamas, Al Qaeda are in the 
neighborhood. So these are very, very early days, and I think 
it would be a tremendous thing if indeed the Assad government 
does want to really forfeit its weapons. I am just not 
convinced that that is the case yet.
    And I think that the Nobel Prize money that will now come
to the OPCW is sadly needed. We need to provide resources to 
this organization so that they can attempt to do this job. So 
stay tuned. There could be some bumps in the road ahead, and it 
could be
also an incredible victory for international peace and chemical
    Mrs. Hartzler. I haven't read extensively at all about 
this, but isn't like the sarin gas in different components and 
then they have to mix it? And so if the theory is they are 
going to take it out, they could take it out in separate stages 
and so they are--all the components wouldn't be together, or 
can you kind of explain, and then how do they actually give--I 
remember you said something about hydrolyze.
    Dr. Smithson. Yes. Certainly. There are two different types 
of chemical weapons basically when it comes to the form that 
they are in. One is a unitary agent, and they are mustard gas, 
which is a World War I agent that was first used in World War I 
is thought to be already mixed.
    Mrs. Hartzler. Okay.
    Dr. Smithson. And whether it is stored in bulk containers 
or in a munition that is already mixed. But you have probably 
heard the term binary chemical weapon.
    Mrs. Hartzler. Uh-huh.
    Dr. Smithson. In this case, the last two chemicals that 
would be used to make the warfare agent is sarin or VX [nerve 
agent] are going to be combined, either right before they are 
filled into the munition or, in the case of the U.S. program, 
which was rather advanced and the Soviet program, they would 
literally be mixed inside the munition on the way to the 
target. So at this point, we are not exactly sure, although a 
lot has appeared in the media, about the character of what the 
stockpile is.
    It is reasonable to expect that some of this will be in 
bulk quantity, others will be in munitions. And when it is 
munitions, keep in mind that the U.S. chemical weapons program, 
the destruction program, as well as the one in Russia, put 
their destruction facilities right beside the storage sites, 
because it is considered a safety hazard just to transport 
these things a short distance even to destroy them.
    And so transporting them through a civil war is--really, 
again, it boggles the mind to think about the courage that 
these inspectors are going to have to exercise in order to get 
this job done.
    And, so the destruction process, there is a capability 
called the U.S. field hydrolysis system, which literally is 
transportable, there are two units that I believe are probably 
headed to Syria, or off the coast as we speak. And this system, 
you would use hot water or other chemical reagents, depending 
upon what you put in there, to degrade the bulk agent down to 
99 percent or even better. So that is definitely a step in the 
right direction.
    And the boom boxes, we have a couple of different systems 
that have also been used in the United States where you can put 
a munition of a certain size inside the boom box and it will 
literally heat up over the course of 2 days, destroy the agent 
and decontaminate the remaining parts of the weapons system.
    So these are some of the options, but right now, we really 
don't have a concrete idea of the condition of this stockpile 
or exactly what the game plan is to getting this very difficult 
job accomplished.
    Mrs. Hartzler. Thank you very much. Thank you, Mr. 
    Mr. Thornberry. Thank you. Let me ask General Russell and 
Dr. Giroir about the relationship between DOD and HHS, because 
some folks believe that DOD has got to focus on protecting 
soldiers, HHS focus on protecting the civilian population, and 
so we have basically two different missions that need to be 
conducted separately. Other folks think that there could be 
much more interaction and collaboration. You heard Mr. Nugent 
ask about fragmentation of effort. So I would just be 
interested in y'all's view about how the two perspectives work 
together and could and should there be more, or is it just two 
different missions and it is not going to work to do more?
    General Russell. The medical countermeasures requirements 
for DOD are quite different from HHS. They do overlap in some 
areas, and--but the basic research and the underlying biologic 
research that is needed to develop the countermeasures is 
fundamentally universal. And so I think the DOD historically 
has drawn on research done at NIH and in the civilian 
community, as well as in its own labs.
    I think the coordination historically has been fairly good. 
There are interagency committees that meet regularly and 
exchange information and discuss how they can work together. I 
know the DOD is using the HHS stockpile for rolling over the 
anthrax vaccine, and if necessary, smallpox vaccine. There are 
interagency agreements that are working.
    On the other hand, there are requirements that the DOD has 
for immunizations, because protecting the warfighter with 
immunization is an important issue, and these are requirements 
that HHS does not have. So there has to be some separate 
activities at the advanced development and purchasing level, 
but the--on the other hand, the military laboratories have 
focused on the problems of the military and have provided the 
important basis for moving ahead. All of the advances in 
tularemia vaccine that have been made came out of military 
efforts. The rPA [Recombinant Protective Antigen] Anthrax 
vaccine came out of USAMRIID, and the military laboratories, 
especially USAMRIID, are still doing very, very good basic 
research that are underpinning the development efforts that are 
    Dr. Giroir. I will just add to that by saying, although 
there are different mission requirements and clearly more of an 
emphasis on vaccines and certain types of vaccines, programs 
such as our HHS center is fully capable of performing the 
advanced development and manufacturing on both military or 
civilian measures. The technologies are all the same, the 
platforms are all very similar. So there is a great ability at 
that level specifically, once they are out of the basic 
laboratory or out of USAMRIID, this very expensive 
infrastructure critical manufacturing piece can certainly be 
shared to a really great degree, because the technologies for 
making military or civilian are all about the same. There is 
nothing that the DOD needs to produce that can't be done with 
the technology that we are developing or have developed with 
HHS at that manufacturing stage.
    Mr. Thornberry. And that infrastructure you talked about 
has been paid for largely by HHS, right?
    Dr. Giroir. Yes, sir. There are three centers, and they all 
have different developments. Our center will be fully developed 
in 5\1/2\ years, but we are ready to take on task orders now. 
Novartis, which is the second center, will be fully developed 
in 4 years,
and Emergent Biosolutions, I believe they are in a 7- or 8-year
contract, but there will be a rolling set of improving, 
    And, again, our contract is cost shared. We have a lot of 
skin in the game, $176 million from the Government and $109 
million from our partners, but all of our centers are ready to 
start working today. We will be fully ready within a few years 
to meet all of the requirements that were brought to us by HHS.
    Mr. Thornberry. Okay. Thank you.
    Dr. Smithson, I am not sure if I got this exactly right, 
but I think part of your testimony talked about who had access 
to certain agents and the screening for individuals who worked 
in certain situations. Obviously, security clearance reform is 
a very significant issue these days, as it should be. Can you 
elaborate just briefly on--you talked about a cost benefit 
study for select agent rules or something like that. Can you 
just elaborate for a second what you are talking about? Are we 
talking about basically a security clearance for people who 
have access to these pathogens or am I misinterpreting?
    Dr. Smithson. It is not sometimes just about the security 
clearance. In the case of Bruce Ivins, who brought the notion 
of an insider threat to everyone's attention, it is about 
whether or not the people who were working in these very high-
pressure environments, and quite frankly, I have never worked 
with an agent where if I pricked my finger, there is no medical 
treatment or vaccine, and basically I am a dead woman walking, 
so I think this is a very high-stress environment. And in the 
case of Bruce Ivins, yes, he did incredible work on the anthrax 
vaccine, but he was also apparently, according to the FBI, 
mentally unstable, he had made death threats and he was abusing 
substances. And this is what is not addressed in the select 
agent rules in a comprehensive manner. For example, the 
screening that the FBI does, according to the select agent 
rules, asks if you have ever been adjudicated mentally 
deficient. It doesn't say, ``are you off your rocker now?''
    And we need to make sure, quite frankly, that the people, 
first and foremost, who are handling these substances and doing 
the work that we all very much want and need them to do have--
have sound judgment exercised. And so that is what I am asking 
for, is to kind of shift the emphasis away from trying to count 
things that are found in nature and that can be replicated, you 
know, on an incredible scale in fermenters toward a system of 
mutual accountability in the laboratory and sound judgment in 
the laboratory. I think these are going to be better defenses 
than trying to lock up pathogens that you can find in Mother 
    Mr. Thornberry. Thank you. Mr. Langevin.
    Mr. Langevin. Thank you, Mr. Chairman. And, again thanks, 
to our panel. As often happens, the chairman and I often are on 
the same wavelength on a lot of these issues, and I would like 
to go back to the question that he asked on DOD and HHS 
resources. And I want to ask, I think, a slightly different 
way, just a different spin on it, but obviously, DOD and HHS, 
in particular, have unique capabilities when it comes to 
biowarfare. To what extent does DOD leverage HHS resources? And 
is it reasonable to expect greater efforts here? And how do DOD 
priorities affect HHS's work? Are we properly leveraging the 
resources of the other, going both ways?
    Dr. Giroir. I am just going to say from our standpoint in 
the HHS center, I can't comment on Novartis or Emergent, but we 
have had a visit from the joint program executive officer with 
all of his staff to look at our facility probably about 7 
months ago. We have had no direct interaction funding task 
orders requests from DOD specifically. We are obviously highly 
motivated to support, because we have tremendous infrastructure 
now and being built. I think HHS is certainly willing to do 
that. Even in our facility, we could dedicate capacity to DOD 
should that be wanted.
    So I would say the conversation, at least in terms of our 
facility, which I could speak definitively about, has started 
to--has begun with high level visits. Where that leads, we 
really don't know.
    Mr. Langevin. Is there anything that you can recommend that 
we do to encourage that?
    Dr. Giroir. I think there should be expectations that where 
resources can be shared, they need to be shared, because I 
believe, as--I would much rather several hundred million 
dollars be put into a tularemia vaccine that achieves the 
capability than duplicating what HHS and the taxpayer has 
already funded.
    Mr. Langevin. I agree. Anybody else want to add anything, 
or I will go to another question?
    General Russell. I have worked on both sides of the fence, 
and the requirements of Department of Defense, although 
somewhat different, are--do overlap tremendously, and as Dr. 
Giroir said, the manufacturing base is fundamentally the same.
    I think we can expect in the future to--DOD requirements 
may benefit by the HHS investments. Whether that is effectively 
coordinated and maximized is, I think, going to be up to the 
senior leadership of the Government.
    Mr. Langevin. I think that is something we have got to 
spend more time focusing on, because we will definitely be able 
to yield better outcomes if we are properly resourced.
    Let me turn to another area. Given the difficulty and the 
time requirements of developing effective countermeasures for 
biological weapons, obviously intelligence plays a critical 
role in identifying potential threats.
    So can you explain the interplay of the intelligence 
community with the biodefense enterprise? And what can be done 
to better identify biological weapon threats that adversaries 
might be developing? And do you see DOD's ability to mitigate 
threats hindered by intelligence capabilities, particularly 
HUMINT [Human Intelligence]?
    General Russell. I think the difficulties that the 
intelligence community has had in dealing with the biologic 
threat is a matter of history. They have not distinguished 
themselves greatly, partly because of a very, very difficult 
intelligence target, probably the single most difficult target 
there is. And in the past, the attention of the intelligence 
community has been on other threats, and the internal 
capability and knowledge about biology has just not been there. 
I think it is improving to some extent.
    Your question about HUMINT, I think, is right on, because I 
think the only way we are going to get decent intelligence 
regarding the biologics threat is by accentuating the human 
side. The other intelligence-gathering methods don't seem to 
work very well against a biothreat.
    Dr. Smithson. The Biological and Toxin Weapons Convention, 
which is the treaty that bans biological weapons doesn't have 
any verification provisions, and that is largely, I think, at 
this point because people refuse to consider the experience of 
the United Nations Special Commission, which I referred to in 
my testimony. What is quite astonishing there is that a very 
small group of inspectors, working off of scant, incomplete, 
and sometimes inaccurate intelligence about Saddam Hussein's 
biological weapons program and working against a government 
that had a game plan to hide that biological weapons program at 
all costs were able to go in and uncover it.
    So the conventional wisdom, again, needs to be rethought. 
And it is far better to have eyes inside a facility, to have 
inspectors engaging with the scientists there, literally 
looking at what they are doing. And, yes, they may not always 
be able to catch everything that is going on, but you are far 
better informed from inside a facility than you are from 3 
miles above the ground with satellite
    And having asked any number of former biological weapons 
scientists what they would do if they were to get back into the 
game, they would aim for the incapacitating agents that I 
referred to earlier, the things that control human behavior, 
because this is considered amongst the weapons scientists to be 
the brave new frontier.
    And last but not least, on the wisdom of relying on human 
intelligence, let's keep in mind the case of ``Curveball,'' and 
this is the Iraqi defector that simply made it up. And he made 
up the whole shebang about Iraq having mobile biological 
weapons production capabilities. If anyone had bothered to ask 
the UNSCOM inspectors at that time whether or not that was a 
realistic scenario, they would have explained that when Iraq 
talked about mobile, they meant moving one part of the program, 
doing one part of the program in one location and another part 
of the program here, and not putting things like that on 
    So conceptually to them, both in terms of the way that the 
Iraqis did both chemical and biological weapons programs and 
also from a scientific standpoint and a safety standpoint, the 
idea of putting mobile biological weapons production out there, 
even if you are a desperate proliferator, just didn't make 
sense. Just a few thoughts for consideration.
    Mr. Langevin. Very good. Thank you. Thank you, Mr. 
    Mr. Thornberry. Mrs. Davis.
    Mrs. Davis. Thank you, Mr. Chairman. This has been very 
interesting. It is always a difficult question. We all could 
like to see more resources, but if I guess the first question 
is, do you think that the resources match the need as we know 
it today and as we are planning in terms of if--perhaps if we 
were better coordinated, but if not, is there any consensus 
among the four of you that there is a place particularly that 
those resources should be going to that would make it--that 
would make a difference overall in terms of the ability to 
leverage those resources for a better outcome? Any consensus?
    Dr. Smithson. The increase in U.S. biodefense programming 
after 2001, some would say, and I would agree, was long, long 
overdue. There are a lot of resources being put into this 
    At this point, I would rather have us do it smarter, as a 
taxpayer, than simply plus up budgets without having the types 
of discussions and decisions that this panel is talking about. 
Let's do it smarter first.
    Mrs. Davis. I think I did hear that. Okay.
    Dr. Bennett. I would suggest, though, much as you were 
suggesting earlier, the military has to pay attention, and they 
are not paying a whole lot of attention to this threat at this 
stage. They are not trained in it, they don't understand in 
many cases at the senior level of the theater commanders, for 
example, the implications it would have for them, that sort of 
thing. So a small investment in the education, I think, and 
focus in requiring it in planning and so forth would make a 
huge impact, at least as far as the military is concerned.
    Mrs. Davis. Thank you.
    General Russell. Yeah. I don't think it is the total amount 
of resources that is as important as the way it is being 
managed and distributed. I think there has been an enormous 
amount of wasted effort in some of these programs, and I think 
better management would accomplish more than just plussing up 
the budget. I think attention to the problem at the highest 
levels is probably more important right now than other aspects 
of it.
    Dr. Giroir. I agree that resources need to be spent 
smarter; the first of that is eliminate all duplication of 
resources across the agency, and I think there is very 
significant ability to do that with sort of upper-level 
management and leadership.
    Secondly, I will say it again, I think efficiency in the 
contracting process and being more outcomes-oriented and less 
micromanagement would certainly improve our efficiency probably 
20 or 30 percent within our center.
    Third, I think the Government should explore more public-
private partnerships where there is cost-sharing. I think there 
can be tremendous alignment with the pharmaceutical industry 
for which their research and development budgets are dwindling, 
to align priorities so there is a little skin on both sides so 
you get more out of the Government dollar than you would 
otherwise, and enable industry to do that.
    And the fourth point I would make is the only area that I 
really think needs more quantitative instead of just smart 
investment is to prepare for the unknowns, and you heard me say 
that before, to try to get a system to understand if something 
we don't expect that we haven't stockpiled for 15 years come 
down the pipeline, what is our capabilities? How do the DOD and 
DHHS work together? How do we attack it, maybe not 100 percent, 
but 80 percent, 90 percent enough to stop the major outbreak? I 
think more resources need to go to that type of threat. The 
others, I think you'd be smarter and you would go a long way.
    Mrs. Davis. Thank you.
    Mr. Thornberry. Well, thank you all. Needless to say, we on 
this committee have limited jurisdiction dealing with DOD, and 
this is not a problem that will be solved within DOD, but on 
the other hand, it seems to me your central point is we need to 
pay more attention to this stuff and DOD can help us do that as 
a Government. And that and a number of other suggestions, I 
think, are helpful to us.
    Again, thank you all for being here. I thought it would be 
good to have a distraction from a budget discussion, but you 
all may drive me back to it, so--but I really do appreciate 
your time and expertise. Thank you again.
    With that, the hearing is adjourned.
    [Whereupon, at 12:48 p.m., the subcommittee was adjourned.]

                            A P P E N D I X

                            October 11, 2013



                            October 11, 2013