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i 

85–327 2013

[H.A.S.C. No. 113–63] 

BIODEFENSE: WORLDWIDE THREATS 

AND COUNTERMEASURE EFFORTS FOR 

THE DEPARTMENT OF DEFENSE 

HEARING 

BEFORE THE

SUBCOMMITTEE ON INTELLIGENCE, EMERGING 

THREATS AND CAPABILITIES 

OF THE

COMMITTEE ON ARMED SERVICES 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

FIRST SESSION 

HEARING HELD 

OCTOBER 11, 2013 
(II) 

SUBCOMMITTEE ON INTELLIGENCE, EMERGING THREATS 

AND CAPABILITIES 

MAC THORNBERRY, Texas, Chairman 

JEFF MILLER, Florida 

JOHN KLINE, Minnesota 

BILL SHUSTER, Pennsylvania 

RICHARD B. NUGENT, Florida 

TRENT FRANKS, Arizona 

DUNCAN HUNTER, California 

CHRISTOPHER P. GIBSON, New York 

VICKY HARTZLER, Missouri 

JOSEPH J. HECK, Nevada 

JAMES R. LANGEVIN, Rhode Island 

SUSAN A. DAVIS, California 

HENRY C. ‘‘HANK’’ JOHNSON, JR., Georgia 

ANDRE ́ CARSON, Indiana 

DANIEL B. MAFFEI, New York 

DEREK KILMER, Washington 

JOAQUIN CASTRO, Texas 

SCOTT H. PETERS, California 

PETER VILLANO, Professional Staff Member 

MARK LEWIS, Professional Staff Member 

JULIE HERBERT, Clerk 
(III) 

C O N T E N T S 

CHRONOLOGICAL LIST OF HEARINGS 

2013 

Page 

HEARING: 

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

APPENDIX: 

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

FRIDAY, OCTOBER 11, 2013 

BIODEFENSE: WORLDWIDE THREATS AND COUNTERMEASURE 

EFFORTS FOR THE DEPARTMENT OF DEFENSE 

STATEMENTS PRESENTED BY MEMBERS OF CONGRESS 

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 

WITNESSES 

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 

APPENDIX 

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.] 

(1) 

BIODEFENSE: WORLDWIDE THREATS AND COUNTERMEASURE EFFORTS FOR THE DEPARTMENT OF DEFENSE 

HOUSE OF REPRESENTATIVES, COMMITTEE ON ARMED SERVICES, SUBCOMMITTEE ON INTELLIGENCE, EMERGING THREATS AND

CAPABILITIES, 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. 

OPENING STATEMENT OF HON. MAC THORNBERRY, A REPRESENTATIVE FROM TEXAS, CHAIRMAN, SUBCOMMITTEE ON 

INTELLIGENCE, EMERGING THREATS 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 
2 

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. 

STATEMENT OF HON. JAMES R. LANGEVIN, A REPRESENTATIVE FROM RHODE ISLAND, RANKING MEMBER, SUBCOMMITTEE ON INTELLIGENCE, EMERGING THREATS AND 

CAPABILITIES 

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 timely 

hearing. 

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 
3 

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 serious. 

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 

objection? 

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. 
4 

STATEMENT OF DR. AMY E. SMITHSON, SENIOR FELLOW, 

MONTEREY INSTITUTE OF INTERNATIONAL STUDIES 

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 agents. 

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 
5 

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 proliferation. 

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. 
6 

[The prepared statement of Dr. Smithson can be found in the Appendix on page 33.] 

Mr. THORNBERRY. Great. Thank you. 

Dr. Bennett. 

STATEMENT OF DR. BRUCE W. BENNETT, SENIOR DEFENSE 

ANALYST, RAND CORPORATION 

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 

uncertainties. 

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 impacts? 

So how can we prepare for and respond to these potential attacks? We must prepare to counter the effects of biological attacks. 
7 

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 example. 

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. 

STATEMENT OF MG PHILIP K. RUSSELL, USA (RET.), SABIN 

VACCINE INSTITUTE 

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. 
8 

The U.S. offensive biowarfare program was very large, very wellfunded, 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 largely 

ignored. 

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. 
9 

STATEMENT OF DR. BRETT P. GIROIR, M.D., INTERIM EXECUTIVE VICE PRESIDENT, TEXAS A&M HEALTH SCIENCE CENTER, TEXAS A&M UNIVERSITY 

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-squarefoot 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 

51⁄2-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 clin-
10 

ical 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. 
11 

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 action. 

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 problem. 

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’ concerns. 

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. 
12 

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 countermeasures? 

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 

gangrene. 

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 
13 

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 program. 

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 problems. 

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 hierarchy. 

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 
14 

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. 
15 

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-theGovernment 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 
16 

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 
17 

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 problem. 

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 
18 

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 population. 

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 idea. 

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 
19 

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 important. 

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 seriously. 

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. 
20 

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 now. 

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 

update? 

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 
21 

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 

disarmament. 

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. 
22 

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. Chairman. 

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 immuniza-
23 

tion 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 

needed. 

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 51⁄2

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, increasing 

capabilities. 

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 environ-
24 

ments, 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 Nature. 

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? 
25 

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 

images. 

And having asked any number of former biological weapons scientists what they would do if they were to get back into the game, 
26 

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 wheels. 

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. Chairman. 

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 arena. 

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 
27 

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 

PREPARED STATEMENTS SUBMITTED FOR THE RECORD 

OCTOBER 11, 2013 

(33) 

1 

House Armed Services Committee 

Subcommittee on Intelligence, Emerging Threats, and Capabilities 

Hearing on Biodefense: 

Worldwide Threats and Countermeasure Efforts for the Department of Defense 

Prepared Statement of Amy E. Smithson, PhD 

Senior Fellow, James Martin Center for Nonproliferation Studies* 

October 11, 2013 

 Since the beginning of time man has co-opted nature’s sources of poison and disease for 

weaponry. Ancient warriors dipped their arrows in poison; fouled water supplies with feces and 

dead animals; bombarded enemies with containers filled with snakes, disease-bearing rodents, 

and scorpions; and hurled human plague cadavers over the walls of besieged cities. These 

rudimentary forms of biowarfare gave way to more advanced weapons in the World War I era, 

when governments put scientists into the equation, asking them to figure out how to wage germ 

warfare more effectively. At that time, advocates of biological weapons lauded their cheapness 

in comparison to other weapons, their ability to offset an opponent’s conventional military 

advantage, their deep psychological impact on an opponent if used, the difficulty of pinpointing a 

biological attacker, and the self-perpetuating nature of a strike involving contagious diseases. 

Finally, proponents noted that, biological weapons leave infrastructure standing, allowing the 

victor to take over the defeated nation’s intact industrial and other capacities. 

Not so long ago, a group of countries known as the “dirty dozen” were thought to be 

harboring offensive biological weapons programs. Today, the number of suspected proliferators 

is down to a handful as concerns have faded about possible programs in Cuba, Libya, Iraq, and 

Egypt. A great many nations, including China, India, Pakistan, and Taiwan, have 

pharmaceutical and biotechnology industries and the scientific know-how to pursue biological 

weapons, but little public evidence exists to sustain suspicions of anything other than that they 

may be “leaning” offensively behind the guise of their biodefense programs. 

The “usual suspects,” however, have apparently not forsaken germ warfare. According 

to U.S., South Korean, and Russian intelligence estimates, North Korea is strongly suspected of 

having an offensive bioweapons program that dates to the 1960s. At universities, medical, and 

specialized institutes North Korea reportedly continues military-applied research on anthrax, 

botulinum toxin, cholera, plague, and perhaps smallpox. Some assessments state that North 

Korea is engaged in research but is poised to weaponize a range of pathogens, while others assert 

that Pyongyang has stockpiled biowarfare agents. When considering this spectrum of 

possibilities, it is useful to keep in mind that scientists in this isolated dictatorship may lack the 

state-of-the-art skills and equipment necessary for advanced biological weaponry. North Korea 

belongs to the treaty that prohibits the development, production, and stockpiling of biological 

weapons, the Biological and Toxin Weapons Convention (BWC). 

 

* Affiliation provided for identification purposes, only. The James Martin Center for Nonproliferation Studies does 

not take institutional positions on public policy issues. 
34 

2 

Syria, which has been embroiled for more than two years in an ongoing civil war that has 

taken over 100,000 lives, is also strongly suspected of having a germ weapons program. In July 

2012, Syrian Foreign Minister Jihad Makdissi stated that Syria would never use chemical or 

biological weapons and that the Syrian military controls all such stockpiles and sites, though he 

later attempted to walk back his perhaps unintentional confirmation of Syria’s unconventional 

weapons capabilities. A United Nations investigative report released on September 16th

contained overwhelming evidence that the regime of Bashir al Assad committed the August 21st

poison gas attacks on the suburbs of Damascus. Assad has since joined the Chemical Weapons 

Convention, and inspectors have taken modest initial steps to begin overseeing the 

dismantlement of Syria’s chemical weapons capability. Syria has signed, but not ratified, the 

BWC. In March 2013 testimony before the Senate Select Committee on Intelligence, Director of 

National Intelligence James Clapper gave the U.S. government’s assessment: Syria has 

stockpiles of biological warfare agents. 

Three other states are suspected of bioweapons activity. Over the past two decades, 

intelligence agencies have voiced concerns about an offensive Iranian biological weapons 

program, but publicly available information is largely inconclusive on the matter. Iran has a 

well-developed biotechnology and pharmaceutical industry that could mask and support a 

significant program, and Tehran’s attempts to acquire dual-use equipment and materials are 

documented. Israel also has a robust biotechnology sector and is believed to have conducted 

extensive biodefense research. The work done in this program is of course relevant offensive 

research, but few experts appear to believe that Israel has stockpiled biowarfare agents. Israel 

has neither signed nor ratified the BWC, but Iran is a BWC member state. 

 Russia, which inherited a Soviet germ weapons program of unparalleled scale and 

sophistication, also remains on the list of suspects. Insider accounts of former Soviet 

bioweaponeers and the distinctive features of many weapons institutes that outsiders have 

observed demonstrate that the USSR’s investment in bioweapons rivaled its nuclear weapons 

program. After inaugurating the BWC in 1975 as a depository nation, Moscow accelerated its 

bioweapons program with a work force of over sixty thousand scientists and technicians, 

including ten thousand who developed and tested anti-crop and anti-livestock agents. The 

Soviets went far past the classic agents like anthrax, pioneering the militarization of hemorrhagic 

fever viruses by successfully weaponizing Marburg, developing two different strains of plague to 

resist five known antibiotics apiece, and also making strains of anthrax, tularemia, and glanders 

resistant to known antibiotics and vaccines. With genetic engineering, the Soviets attempted to 

create entirely novel virulent strains, including ones that produced toxins. Other Soviet 

bioweaponeers conducted research with bioregulators and neuro-modulating peptides, which are 

incapacitating agents that can affect individual behavior, for instance by stimulating insomnia 

and increasing aggressiveness. The capstone of this massive covert weapons program was 

stockpiles of hundreds of tons of anthrax and dozens of tons of plague and smallpox, mainly for 

use against U.S. and other Western non-battlefield targets. 

In the spring of 1992, Russian President Boris Yeltsin stated the bioweapons program 

would be closed, but thereafter Moscow quickly began denying that the program ever amounted 

to anything and to this day maintains a stony silence about the Soviet bioweapons program. In 
35 

3 

its 1992 voluntary declaration under the auspices of the BWC, Russia stated that the USSR did 

not amass biological weapons and claimed that inadequate methodology, equipment, and 

materials meant that Soviet bioweaponeers failed to achieve anything militarily significant.

Governments and former top Soviet bioweapons scientists have publicly voiced suspicions that 

Russia continues to conduct offensive research and development. Russia still denies outsiders 

any access to key military biological facilities that were critical components of the Soviet germ 

weapons program, including the Center for Military-Technical Problems of Anti-Bacteriological 

Defense at Ekaterinburg, formerly Sverdlovsk; the Scientific Research Institute of Military 

Medicine in St. Petersburg; the Scientific Research Institute of Microbiology at Vyatka; and the 

Virology Center of the Scientific Research Institute of Microbiology at Sergeev-Posad. For 

these and other reasons, the 2013 U.S. arms control compliance report states that it remains 

“unclear if Russia has fulfilled its obligations under . . . . the BWC.”

The BWC contains no on-site verification measures to ascertain treaty compliance, so the 

onus for estimating the number, scale, and sophistication of state-level bioweapons programs 

falls to the intelligence community. This situation is problematic because from the outside 

looking in, the intelligence “signatures” of biological weapons programs are far less discernible

than nuclear or chemical weapons programs. Even the telltale signs, such as the presence of 

high-level biosafety containment, that do exist are not always reliable. Prior to the 1991 Gulf 

War, U.S intelligence did not identify Iraq’s principal bioweapons production facility, Al 

Hakem, even though this site had a layout very similar to Iraq’s main chemical weapons 

production site, Al Muthanna. Without biosafety containment equipment, Iraq produced anthrax 

and botulinum toxin at Al Hakem. In the late 1980s, Iraq powered up its germ weapons program 

with huge purchases of the nutrients needed to grow biowarfare agents. Before that, under the 

guise of legitimate research Iraqi scientists ordered the seed cultures for anthrax, botulinum 

toxin, and other agents from culture collections in the United States and France. U.S. 

intelligence apparently did not detect these activities, although in the mid-1990s Israeli 

intelligence did pick up indications of Iraq’s growth media purchases. In 2005, the Commission 

on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction 

stated that the U.S. intelligence community “substantially underestimated the scale and maturity 

of Iraq’s” bioweapons program prior to the 1991 Gulf War and that the US intelligence 

assessment about the threat of Iraq’s rejuvenated biological and chemical weapons programs, 

notably its alleged mobile bioweapons production trailers, prior to the 2003 Gulf War was 

“simply wrong.”

Finding signs of terrorist interest and activity in biological weapons arena is even more 

difficult. In the past couple of decades, sub-national actors also have occasionally turned to 

germ warfare. Aum Shinrikyo, the Japanese cult best known for its mid-March 1995 attack with 

the nerve agent sarin in Tokyo subway system, also tried to master biological weaponry. 

However, the cult’s scientists failed utterly at two essential steps. First, they did not acquire 

virulent strains of the disease-causing agents they tried several times to disseminate from 1990 to 

1995. Second, Aum was unable to develop and test effective dispersal systems for biowarfare 

agents. U.S. intelligence agencies admitted in 1996 testimony before the Senate Committee on 

Government Affairs that they were not aware of the cult’s unconventional weapons programs 

until after the subway attack. 
36 

4 

 In America, another cult, the Rajneesh, tested a plot in 1984 to keep voters away from the 

polls in a Wasco County, Oregon, election by sprinkling Salmonella typhimurium on salad bars 

and elsewhere, sickening 751. Public health authorities, not law enforcement and intelligence 

officials, connected this surge in gastrointestinal illness to deliberate acts. According to the 

Federal Bureau of Investigation, Dr. Bruce Ivins, a 26-year veteran of the U.S. Army Military 

Research Institute for Infectious Diseases (USAMRIID) sent five letters with freeze-dried 

anthrax to U.S. senators and media outlets in the fall of 2001. The FBI originally turned to Ivins 

to help them investigate the attacks, only fingering him as the culprit in 2008. Evidence 

indicates that Ivins may have prepared the anthrax used in the 2001 attacks inside his Ft. Detrick 

laboratory. The 2001 anthrax attacks inspired a wave of bioterrorism hoaxes and plots and a 

handful of genuine events. For example, in 2003 an unknown person or group tried to blackmail 

the U.S. government not to implement new trucking regulations by sending a chain of letters 

with containers of powdered ricin and threats to make Washington, DC, “a ghost town.” Ricinlaced letters reappeared in 2013; two U.S. citizens have been charged with mailing ricin to 

prominent politicians, a judge, and a gun control advocacy group. 

 Despite increase indications of terrorist interest in and intent to commit acts of 

bioterrorism, sub-national actors are still much more likely to attack with traditional tools (e.g., 

bombs, guns) rather than disease. Nonetheless, experts and policy makers alike consider a major 

bioterrorist attack to be a when-not-if matter, predicting such an attack in the near- to mid-term 

future. Economist Martin Shubik argues not just the inevitability, but the “high probability” of

mass casualty biological attacks because “[b]iological weapons, with their easy accessibility, 

lack of effective international controls, and disproportionately large effectiveness, offer a 

singularly attractive mix to radical groups.”

 The history of biological weapons activities to date has few concrete patterns save one: 

bioweapons proliferators shroud their activities in utmost secrecy. Beyond that, biowarfare 

programs come in all sizes and types, from grandiose, resource rich, high-tech ones to small, 

almost primitive, efforts funded on a shoestring. Some state-level proliferators aimed for 

incapacitating diseases, others only weaponized the anti-personnel diseases for which 

vaccinations and medical treatments were available, and yet others turned untreatable and even 

entirely novel diseases into weapons. Some bioweapons possessors used their arms against 

humans and animals, others amassed but did not use their germ arsenals. Terrorists have shown 

little, if any interest in anti-agricultural agents, but some nations devoted considerable resources 

to anti-agricultural agents. These variances complicate the efforts of security and intelligence 

analysts to identify or anticipate the nature of current and future offensive bioweapons programs, 

of U.S. scientists to improve defenses against biological weapons, and of policy makers to 

formulate steps to prevent and punish proliferation. 

Research with pathogens is essential to decode the inner workings of diseases and to 

develop diagnostics, therapeutics, and vaccines to combat infectious disease. This research 

forms the core of U.S. biodefense and is also necessary to safeguard the public from natural 

eruptions of disease. In the wake of the 2001 anthrax attacks, the U.S. budget for biodefense has 

increased manifold, from $414 million in FY 2001 to $5.54 billion in FY2013. Likewise, the 

number of U.S. high containment, biosafety-level 4 laboratories, which increase the safety of 

research with highly lethal and contagious diseases, jumped from five to fifteen. 
37 

5 

The U.S. boom in biodefense has caused some at home and abroad to question whether 

the United States may have resumed the offensive bioweapons activity that U.S. President 

Richard M. Nixon shut down on November 25, 1969, with the observation that “mankind already 

carries in its own hands too many of the seeds of its own destruction.” U.S. scientists have 

spoken of their apprehensions about the type of research performed at the some of the new BL-4 

facilities and lack of access to those sites, and representatives of other countries have expressed 

concerns about possible U.S. noncompliance with the BWC. Therefore, it is worth keeping in 

mind that the more transparency the Defense and Homeland Security Departments provide into 

this programming, the more likely such worries will be allayed and the less likely it will be that 

U.S. biodefense programming will unintentionally launch an arms race in germ weapons by 

other countries that miscalculate U.S. intentions and activities. 

U.S. biodefense programs already have and will continue to benefit from the new 

techniques, equipment, and knowledge that are propelling life sciences developments at a 

breakneck pace. The life sciences revolution will also boost environmental remediation, energy 

generation, agricultural productivity, and other discoveries in medicine. Cutting-edge life 

sciences techniques, knowledge, materials, and equipment may, however, be deliberately or 

inadvertently misapplied. The field of life sciences is so dynamic that do-it-yourselfers, known 

as biohackers, are being drawn to it. Along with countless others, those in DIY bio are availing 

themselves of the advantages of advanced automated equipment that “de-skills” complex life 

sciences techniques and processes. 

One of the new life sciences disciplines that has raised security concerns is synthetic 

biology, the ability to generate microorganisms de novo from base pairs of nucleic acids. 

Already, among other pathogens, scientists have artificially created the polio and 1918 influenza 

viruses that killed and crippled tens of millions worldwide in the twentieth century. With each 

passing year, scientists can assemble more complex microorganisms from scratch in shorter 

amounts of time. Base pairs for synthetic assembly can be purchased for just a few dollars, so 

synthetic biology opens the way for governments and sub-national actors alike to put together 

rare and tightly controlled pathogens as well as eradicated diseases. Moreover, before long 

proliferators will be able to print whatever DNA sequences they wish. Several companies are 

developing desktop DNA printers. 

Other important new technologies at the forefront of the life sciences revolution, like 

RNA interference and nanobiotechnology, are also vulnerable to abuse. Malicious actors could 

combine sophisticated targeted-delivery technologies with bioregulators, which can be directed 

to manipulate the human immune, nervous, and endocrine systems. In June 2000, geneticist and 

molecular biologist Matthew Meselson observed: “A world in which these capabilities are 

widely employed for hostile purposes would be a world in which the very nature of conflict has 

radically changed. Therein could lie unprecedented opportunities for violence, coercion, 

repression, or subjugation.” These worrisome possibilities simultaneously underscore the need 

for biodefense programs and the need to consider how the architecture that governs life sciences 

research can be strengthened to reduce the chances that the governments and sub-national actors 

will exploit the dark side of the life sciences. 

 
38 

6 

Conceptually, institutional peer review boards are the watchdogs that help ensure that life 

sciences research is performed responsibly and safely. In the United States and many other 

countries, peer governance of scientific research is not exercised comprehensively or evenly. 

Evidence also indicates that where such committees exist they do not always function 

effectively. Not only are these committees an unfunded mandate, the self-regulatory approach is 

innately handicapped because scientists are sometimes reluctant to restrict the work of other 

scientists. As the debate about various governance approaches for the life scientists has 

unfolded, plenty of its practitioners have grumbled about oversight of their work, resisting 

constraints that might serve the interests of security. The flood of advances in the life sciences 

has underscored the need to update oversight mechanisms, and esteemed scientific advisory 

panels proposed upgrades to existing oversight procedures. 

Much of the debate has revolved around biosecurity, which consists of measures that are 

intended to foil the theft or diversion of high-risk pathogens. U.S. biosecurity procedures, 

known as the Select Agent Rules, took shape after a 1995 incident when a lieutenant in the 

Aryan Nations, Larry Wayne Harris, used false pretenses to buy three vials of bubonic plague 

from a U.S. pathogen repository. Though the ruse was spotted before Harris could attempt foul 

play, the incident sparked the maiden U.S. biosecurity regulations to control the transfer of and 

access to select pathogens. Known euphemistically as the “guns, guards, and gates” approach 

because physical security is one of its core components, biosecurity can also encompass 

licensing of facilities to work with pathogens; procedures to ensure the accountability of 

pathogens and to ascertain personnel reliability; pre-transport approval of transfers of pathogens 

and appropriate security during transport; oversight of scientific, commercial, and defense work 

with pathogens; and appropriate security for information related to processes and techniques 

useful in weaponizing an agent. 

Poorly designed regulations do not ameliorate a problem, they exacerbate it. Current 

select agent regulations, it is important to recognize, would not have stopped anthrax letter 

attacker Ivins. In its indictment of Ivins, the FBI released information that shows that Ivins was 

mentally unstable and that he was abusing alcohol and drugs. Employees hired through a 

personnel screening process that concentrates on criminal, financial, and professional 

background checks but superficially addresses mental health, substance abuse, and lifestyle 

issues means that laboratory workers could be high or inebriated on the job, emotionally 

disturbed, or extorted to reveal private matters (e.g., nudist club membership). U.S. biosecurity 

procedures do not require substance abuse screening and address mental health matters 

tangentially. In 2009, the U.S. National Advisory Board on Biosecurity declined to recommend 

full-scope screening for researchers working with high-risk pathogens, citing worries that more 

intrusive initial and ongoing personnel screening could cause scientists to abandon this 

specialized area of research. 

A 2009 inventory of USAMRIID’s culture collection revealed yet another shortcoming of 

the Select Agent Rules approach. This inventory turned up 9,220 vials not listed in the facility’s 

computerized inventory, including vials of botulinum neurotoxins and the Ebola, Junin, Rift 

valley fever, and Venezuelan and Western equine encephalitis viruses. USAMRIID officials 

chalked this jumble up to errors made when the facility computerized its pathogen inventory in 

2005 and samples that departing workers left behind in the facility’s 335 freezers and 
39 

7 

refrigerators. Unable to rule out foul play, including the possibility that someone smuggled out 

vials, USAMRIID officials pointed to deterrent measures that they have since added, such as 

video cameras in the laboratories, exit checks of personnel, stepped up personnel screening and 

pathogen cataloging and auditing procedures, and random internal inspections. If USAMRIID’s 

2009 inventory saga illustrates anything, it is just how misapplied the paradigm of nuclear 

controls is in the life sciences world. 

The protection, control, and accountability of nuclear materials can be exercised because 

of the ability to detect, weigh, and confirm quantities of nuclear materials. In contrast, scientists 

consider a precise inventory of culture collections to be somewhat futile first because 

microorganisms can be isolated from nature. Laboratory pathogens can also be replicated and 

stored in deliberately mislabeled containers without drawing undue attention. Moreover, as 

synthetic biologists worldwide sharpen the techniques to create pathogens artificially, the 

concepts of restricting access to pathogens and taking precise inventories will become less 

relevant to preventing villainy. For these reasons, life scientists regard “locking up” pathogens 

as a costly hindrance with dubious security gains. 

The concept and practice of biosecurity is in serious need of an overhaul, but the 

Executive Branch seems inclined to live with the devil it knows, the Select Agent Rules, despite 

evidence that those regulations may have important opportunity costs for U.S. biodefense. Some 

top scientists and laboratories have apparently opted out of work with high-risk pathogens. 

Therefore, Congress should require the Executive Branch to prepare a cost-benefit study on the 

Select Agent Rules and alternative approaches to biosecurity. 

Common sense indicates that the emphasis in biosecurity should be placed on personnel 

reliability rather than guns, guards, and gates. The time has come for life scientists to accept that 

working with certain materials, equipment, and technology is a responsibility, not a right because 

their mistakes could have severe consequences for the public at large. Several professions with a 

significant bearing on public safety−law enforcement officers, airline pilots, those working in the 

U.S. nuclear weapons program−have mandatory full-scope personnel screening to help shortcircuit accidents and other employee misdeeds. Similarly, scientists in high-biosafety 

containment laboratories should be screened initially and periodically after hiring for problems 

(e.g., depression, substance abuse, susceptibility to coercion) that could negatively influence 

their reliability, trustworthiness, and reasoning. Accordingly, reconfigured regulations for highbiosafety level laboratory work should step up personnel screening requirements, streamline and 

reduce inventory control requirements, and establish procedures to create a “culture of 

responsibility” in life sciences laboratories. 

Far, far too often, a scientist’s knowledge of important biosafety, biosecurity, and 

research oversight procedures depends on the inclinations and 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. All colleges and universities granting undergraduate and graduate life sciences 

degrees should be required to include instruction on the ethical aspects of life sciences research, 

the BWC’s prohibitions, and the fundamentals of biosafety, biosecurity, and research oversight

in their curricula. All institutions working with high-risk pathogens should be obligated to 
40 

8 

provide regular refresher training on these matters. All scientists handling high-risk pathogens 

should have to demonstrate competency in biosafety, biosecurity, and research oversight 

procedures that is commensurate with their job responsibilities. 

For the time being, the most severe biological threats that America faces will be from 

natural disease outbreaks and state-level bioweapons programs. As noted, the ability of 

intelligence to find and characterize covert bioweapons programs is lacking, so the United States 

needs to go back to the drawing board on data collection strategies, tactics, and tools that can be 

used to monitor biological facilities. The U.S. government appears to have done little to learn 

from the invaluable experience of the United Nations Special Commission’s biological 

inspections, and this oversight merits correction. With ordinary inspection tools−observation, 

document tracking, interviews−and old-fashioned gum-shoe detective work, the inspectors 

collected considerable evidence that Iraq was hiding a bioweapons program behind a façade of 

civilian activity. The United Nations Special Commission reported Iraq’s development, 

production, and weaponization of biowarfare agents to the Security Council, compelling Iraq to 

admit culpability. Thus, the experience of the United Nations Special Commission stands as a 

direct challenge to the conventional wisdom that the BWC is “inherently unverifiable.” 

Since the effectiveness of U.S. biodefense depends in no small part on the quality of U.S. 

biological threat assessments, Congress should require a study evaluating the limitations and 

prospective contributions of intelligence and inspections to the standing need to detect and deter 

bioweapons proliferation. The study should address the utility of these tools in isolation of each 

other as well as the potential synergy between intelligence, increasingly powerful sampling and 

analysis capabilities, analysis of import/export data, and other on-site inspection tools. This 

study should include an assessment of how the global institutionalization of cross-cutting 

biosafety, biosecurity, and research oversight standards might benefit detection of covert 

bioweapons activity. Such standards would generate a voluminous data that can be perused to 

aid efforts to separate legitimate peaceful biological work from illicit biowarfare activities. This 

appraisal could find that inspections can be expected to detect certain biowarfare activities 

reliably, such as the stockpiling of biological weapons and bulk agent production, but not 

necessarily to catch offensive research and development of biological weapons. Whatever the 

study’s conclusions, the analytical process entailed would be a springboard to identify 

alternatives to give U.S. policy makers more data of a more reliable quality about suspected 

bioweapons activities, which would in turn inform U.S. biodefense programs. 
41 

CNS Washington, DC, Office 

1400 K Street, NW | Suite 450 | Washington, DC 20005 

Tel: 202.842-3100 | Fax: 202.842.0556 

http://www.cns.miis.edu 

James Martin Center for 

Nonproliferation Studies 

Monterey Institute of International Studies 

An Affiliate of Middlebury College 

Amy E. Smithson, Ph.D. 

Senior Fellow 

Amy E. Smithson specializes in in-depth field research on issues related to dualuse chemical and biological technologies, weapons proliferation, threat reduction 

mechanisms, defense, and homeland security. She has addressed such topics as the 

reduction of US and Russian weapons capabilities, the overhaul of China’s regulations 

related to the conduct of life sciences research, the status of international treaties 

outlawing these weapons, export controls, unconventional terrorism, and preparedness 

for biological and chemical disasters. Often fashioning untraditional issue alliances 

that cross the private and public sectors and international borders, Smithson’s work 

recommends practical steps that blend technical and policy instruments to reduce 

threats and to enhance civilian and military defense, preparedness, and response 

capabilities. Before joining the Center for Nonproliferation Studies, she worked at the 

Center for Strategic and International Studies and the Henry L. Stimson Center, where 

in January 1993 she founded the Chemical and Biological Weapons Nonproliferation 

Project. Previously, she worked for Pacific-Sierra Research Corporation and the 

Center for Naval Analyses. 

Smithson’s work has prompted numerous invitations to testify before Congress, 

and she has frequently assisted the electronic and print media. Her latest work, Germ 

Gambits: The Bioweapons Dilemma, Iraq and Beyond, debunks myths about how 

United Nations Special Commission inspectors uncovered Iraq’s covert bioweapons 

program after the 1991 Gulf War. The vice chair of the World Economic Forum’s 

Global Agenda Council on Nuclear, Biological, and Chemical Weapons, Smithson 

earned a PhD in political science at George Washington University, an MA in 

international relations at Georgetown University, and BA’s in political science and 

Russian at the University of North Carolina, Chapel Hill. 
42 

Testimony 

The Challenge of North Korean Biological 

Weapons

Bruce W. Bennett 

RAND Office of External Affairs 

CT-401 

October 2013 

Testimony presented before the House Armed Services Subcommittee on Intelligence, Emerging Threats and Capabilities on 

October 11, 2013 

This product is part of the RAND Corporation testimony series. RAND testimonies record testimony presented by RAND associates 

to federal, state, or local legislative committees; government-appointed commissions and panels; and private review and oversight 

bodies. The RAND Corporation is a nonprofit research organization providing objective analysis and effective solutions that address 

the challenges facing the public and private sectors around the world. RAND’s publications do not necessarily reflect the opinions of 

its research clients and sponsors. is a registered trademark. 
43 

Published 2013 by the RAND Corporation 

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RAND URL: http://www.rand.org/ 

To order RAND documents or to obtain additional information, contact 

Distribution Services: Telephone: (310) 451-7002; 

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44 

1

Bruce W. Bennett1

The RAND Corporation 

The Challenge of North Korean Biological Weapons2

Before the Committee on Armed Services 

Subcommittee on Intelligence, Emerging Threats and Capabilities 

United States House of Representatives 

October 11, 2013 

Chairman Thornberry, Ranking Member Langevin, and members of the Subcommittee, thank you 

for inviting me to testify at this hearing, “Biodefense: Worldwide Threats and Countermeasure 

Efforts for the Department of Defense.” While there is evidence of North Korean biological 

weapons, little is known with certainty about the biological weapon agents the North has 

developed, which of these agents it has weaponized, and how it would use them. Still, North 

Korean biological weapons could pose a fearsome threat to the Republic of Korea (ROK) and 

even the United States, and the ROK and the United States need to be prepared for that threat to 

be carried out. 

This testimony addresses the nature of the potential North Korean biological weapon threat and 

how the ROK and United States should prepare to counter potential biological weapon attacks. It 

discusses the biological agents that North Korea may have pursued, how those agents could be 

spread, and the potential damage that biological weapon attacks could cause. It then describes 

options for countering biological weapon attacks, from interdicting such attacks to detecting them 

and treating the affected people. Some of these counters have been fielded, supporting 

deterrence of a North Korean biological weapon attack. But more effort is warranted in these 

areas in order to avert the effects North Korea could cause and thereby strengthen deterrence of 

a North Korean biological weapon attack. 

North Korean Biological Weapons 

North Korea has been very effective in denying the world information about its biological weapon 

programs. North Korea practices such information denial across almost all of its military 

 

1

 The opinions and conclusions expressed in this testimony are the author’s alone and should not be 

interpreted as representing those of RAND or any of the sponsors of its research. This product is part of the 

RAND Corporation testimony series. RAND testimonies record testimony presented by RAND associates to 

federal, state, or local legislative committees; government-appointed commissions and panels; and private 

review and oversight bodies. The RAND Corporation is a nonprofit research organization providing objective 

analysis and effective solutions that address the challenges facing the public and private sectors around the 

world. RAND’s publications do not necessarily reflect the opinions of its research clients and sponsors. 

2

 This testimony is available for free download at http://www.rand.org/pubs/testimonies/CT401.html. 
45 

2

activities.3 Biological weapon programs are easier to hide than most military programs because 

they can be developed in a university setting or hidden within efforts to develop related vaccines. 

As a result, the outside world has little direct information on North Korean biological weapons and 

therefore has mainly indirect inferences, creating substantial uncertainties. 

Information Available About North Korean Biological Weapons 

Among the evidence available, several observations stand out. The first, from a Republic of 

Korea Ministry of Defense White paper, traces the initiative for North Korean biological weapons 

development back to the 1980s. 

“In the 1980s, the military turned to the development of biological weapons 

according to Kim Il-sung’s directive that ‘poisonous gas and bacteria can be used 

effectively in war.’ ... The North is also suspected of maintaining numerous 

facilities for cultivating and producing the bacteria of anthrax and other forms of 

biological weapons.”4

A second observation comes from a Russian intelligence report from the early 1990’s. 

“In 1993, the Russian Foreign Intelligence Service, successor to the Soviet 

Union’s KGB, released a statement that said, in part: ‘North Korea is performing 

applied military-biological research in a whole number of universities, medical 

institutes and specialized research institutes. Work is being performed in these 

research centers with inducers of malignant anthrax, cholera, bubonic plague 

and smallpox. Biological weapons are being tested on the island territories 

belonging to the DPRK (Democratic Peoples Republic of Korea).’ Mr. Gordon 

Oehler, director of the CIA’s [Central Intelligence Agency’s] Non-Proliferation 

Center, confirmed this Russian report.”5

And a third open-source reference cites reports from North Korean defectors over the 

past decade. 

“Sporadic reports by defectors during 2003–2004 and 2009 state that the DPRK 

has conducted testing of biological agents on political prisoners. For example, 

‘...tests are conducted on political prisoners by the College for Army Doctor and 

Military Officers and Kim Il-sung University Medical College.’ While these reports 

present numerous details, they are extremely difficult to confirm. They do, 

however, conform to older reports of this nature that have occasionally appeared 

since the late 1970s. Taken as a whole, and within the context of what is 

currently known about the treatment of political prisoners within the DPRK, such 

 

3

 “The DPRK [Democratic People’s Republic of Korea] is the most closed and security-conscious society in 

the world. This situation has developed since the earliest days of Kim Il-sung's rule as a means of isolating 

and eliminating potential internal threats, controlling society and limiting foreign intelligence collection. The 

KWP [Korean Workers’ Party] and National Defence Commission, through a host of overlapping 

organisations and security agencies, maintain near-absolute control over its citizens and soldiers and the 

information to which they have access.” “North Korea: Strategic Weapons Systems,” Jane's Sentinel 

Security Assessment - China and Northeast Asia, July 7, 2011. 4

 The Republic of Korea Ministry of National Defense, Defense White Paper, 2000, p. 58. 5

 Frederick R. Sidell, et al., Medical Aspects of Chemical and Biological Warfare, 1997, pp. 461–462, 

available at http://www.bordeninstitute.army.mil/published_volumes/chemBio/ch21.pdf (accessed on Oct. 

23, 2009). This document cited the original source as: J. Fialka “CIA says North Korea appears active in 

biological, nuclear arms,” Wall Street Journal. Feb 25, 1993, p. A-10. 
46 

3

reports suggest a long-standing DPRK policy of low-level lethal testing of 

biological agents on unwilling human subjects.”6

Other suspicions grow out of the North Korean vaccine programs: 

“During the past ten years DPRK scientists and researchers have engaged in 

research to produce vaccines and diagnostic test kits for avian flu, Severe Acute 

Respiratory Syndrome (SARS) and anthrax. In 2004 scientists and researchers 

from the Central Hygiene Center, Ministry of Health, produced a[n] anthrax rapid 

diagnostic kit. Such research is not only valuable for defensive biological warfare 

but could be directly applicable to offensive operations.”7

 

Since anthrax is not a major health concern in North Korea, one must wonder, in particular, about 

the motivation behind the North Korean anthrax defensive programs. 

As another example, Korean Hemorrhagic Fever (also called Hemorrhagic Fever with Renal 

Syndrome, or HFRS) is endemic to North and South Korea. Anxious to reduce the impact of this 

disease, Dr. H. W. Lee of South Korea developed a “human inactivated” virus vaccine for Korean 

Hemorrhagic Fever.8

 More than 20 years ago, Dr. Lee reported that the North Koreans developed 

a similar vaccine, which in 1990 had already been given to 30,000 people.9

 Since North Korea 

rarely provides antibiotics for most public health challenges, the development of this vaccine 

suggests a possible military interest in its availability. 

Likely North Korean Biological Agents 

The many biological agents that North Korea apparently has been or could be developing are 

listed in Table 1. This table shows the type of each biologic agent, its potential lethality, the 

number of cases reported in Korea and the United States in recent years, and references (if any) 

that identify these agents as part of the North Korean biological weapon program. 

It is important to note that the initial detectability of an attack varies by biological agent. With 

diseases like malaria, Korean Hemorrhagic Fever, and especially tuberculosis, the initial number 

of cases resulting from a biological weapon attack might not differ from the number of naturally 

occurring cases enough to cause doctors or other health care professionals to recognize that an 

attack has occurred. It may take many hours or longer before it is clear that a disease outbreak is 

not a natural occurrence. 

 

6

 “North Korea: Strategic Weapons Systems,” Jane's Sentinel Security Assessment - China and Northeast 

Asia, July 7, 2011. 

7 Ibid.

8

 H. W. Lee, et al., “Field trial of an inactivated vaccine against hemorrhagic fever with renal syndrome in 

humans," Archives of Virology, Supplement 1, 1990, pp. 35–47. 9 Ibid., p. 46. 
47 

4

There has been widespread discussion of North Korea developing anthrax as a biological agent, 

as well as many references to it developing cholera, plague, and smallpox. For example, 

speaking of the smallpox virus, Dr. Ken Alibek, a former senior scientist in the Soviet biological 

weapon program, has said: 

“I'm 100% sure North Korea still has this virus. Even in the late 80s, we had 

some information obtained from Soviet intelligence service that North Korea was 

developing biological weapons, involving anthrax, plague, smallpox and several 

others.”13 

Potential North Korean Uses of Biological Weapons 

The Republic of Korea Ministry of Defense asserts that “[t]he North may also dare to launch a 

secret attack in the rear through its SOF [special operations forces] troops armed with biological 

weapons.”14 Even a kilogram of many types of biological weapons could disrupt most military 

targets if delivered properly,15 and this quantity could easily be delivered by special operations 

forces. Missiles and aircraft could also deliver this quantity of biological weapons.16 

Indeed, North Korea special forces are a likely means for delivering North Korean biological 

weapons. North Korea has some 200,000 special forces,17 a small fraction of which could deliver 

devastating biological attacks against South Korea, Japan, and even the United States.18 North 

Korea could use biological agents in isolation, perhaps as an escalated provocation in which it 

seeks to infect a limited number of people, or it could use biological agents as the leading edge of 

an invasion of the ROK, hoping for thousands or even more infections to weaken the ROK’s 

defenses and will to fight. Biological weapon use in the latter context is particularly worrisome. 

 

13 “Interview —Dr. Ken Alibek,” Homeland Defense, September 28, 2000. 

14 The Republic of Korea Ministry of National Defense, op. cit. 15 As will be discussed below, 1 kilogram of anthrax would potentially infect people in a 2.6 square kilometer 

area. 

16 For example, the AN-2 aircraft North Korea would use for delivering special forces into the ROK are 

difficult to intercept, and could carry biological weapon sprayers in addition to special forces. 17 The Republic of Korea Ministry of National Defense, 2012 Defense White Paper, p. 31. 18 North Korean special forces could bring biological agents into the United States covertly, long before an 

attack. They could also infect the noncombatants leaving Korea with contagious biological agents, causing 

disease to emerge, after incubation, in the United States. 
48 

5

Table 1 

Potential North Korean Biological Agents 

Type of 

Agent 

Untreated

Lethality

Korean Cases U.S. 

Cases 

BW Agent 2010* 2011* 2011** NK BW Source19

Anthrax Bacteria High 0 0 1 KRIS, USFK, Alibek, WP 

Botulinum Toxin High 0 1 153 USFK 

Brucellosis Bacteria <5% 31 19 79 KRIS 

Cholera Bacteria 50+% 8 3 40 KRIS, USFK 

Dengue fever Virus 1%a 125 72 3 

Diphtheria Bacteria 5–10% 0 0 ? KRIS 

Dysentery Bacteria Low ? ? ? KRIS 

E. coli Bacteria 3-5%a 56 71 2,575 

Hemorrhagic 

 fever(HFRS) Virus 5–15% 473 370 23 KRIS, USFK, Alibek, WP 

Hepatitis Virus Low ? 7,247c 4,301 c KRIS 

Japan. Encep. Virus 60% 26 3 ? 

Malaria Parasite Low 1,772 838 1,724 

Pertussis Bacteriab Lowa 27 97 18,719 

Pnm. plague Bacteriab High 0 0 3 KRIS, USFK, Alibek, WP 

Q Fever Bacteria Low 13 8 134 

Smallpox Virusb 20–40% 0 0 0 USFK, Alibek, WP 

Tuberculosis Bacteriab High 36,305 39,557 10,528 KRIS 

Tularemia Bacteria Moderate 0 0 166 KRIS, WP 

Typhoid fever Bacteria Moderate 133 148 390 KRIS, USFK 

Typhus Rickettsia Moderate 54 23 ? KRIS 

Yellow fever Virus Moderate 0 0 0 Alibek, USFK a With treatment 

b Contagious 

c Hepatitis A and B 

* Data from the Korea Centers for Disease Control and Prevention (KCDC): 

http://www.ksid.or.kr/admin/mail/download.php?num=69 

** Data from the U.S. Centers for Disease Control and Prevention (CDC): 

http://www.cdc.gov/mmwr/PDF/wk/mm6053.pdf; typhus is not reported. 

 

19 Sources: USFK = General Leon J. LaPorte, “Statement before the Senate Armed Services Committee,” 

April 1, 2004; KRIS = The Strategic Balance in Northeast Asia, 2003, Korea Research Institute for Strategy 

(KRIS), December 2003, p. 363; Alibek = “Interview—Dr. Ken Alibek,” Homeland Defense, September 28, 

2000 and “Biological War: Are We Prepared? Dr.'s Q&A,” Ivanhoe Broadcast News, October 2001 

(http://search.ivanhoe.com/archives/ p_archive.cfm?storyid=1437& channelid=CHAN-100021); WP = The 

Republic of Korea Ministry of National Defense, 2012 Defense White Paper, p. 36. 
49 

6

The Potential Effects of North Korean Biological Weapons 

The People Infected. North Korea could use biological weapons against a variety of military and 

civilian targets in South Korea. Biological weapons would likely be delivered as an aerosol of 

some kind that would be dispersed and then carried by the wind. Many people downwind of the 

release location would be exposed unless they wore some form of protection or were physically 

located in a place that protected them from exposure. This is particularly true if the attacker 

creates a line source by spraying, for example, the BW agent while driving along a road 

perpendicular to the wind. According to one source, 1 kilogram of anthrax could spread lethal 

effects over 0.2 to 2.6 square kilometers, depending on wind and weather conditions.20 The 

nighttime population density of Seoul averages about 20,000 people per square kilometer, 

meaning that upward of about 50,000 people could be effectively exposed by 1 kilogram of 

anthrax. But in conditions less favorable to the attacker, including poor atmospheric conditions 

and many people living in high-rise buildings that lack central heating and ventilation, as few as 

2,000 people might be effectively exposed by 1 kilogram of anthrax. Multiple attacks could 

increase these results. 

Contagious Agent Infections. A key agent characteristic is whether the agent is contagious, as 

in the cases of plague and smallpox. These diseases may affect not only those exposed by an 

initial North Korean attack, but those who become sick by being infected by others. The ability to 

spread a contagious disease is reflected in the term Ro, which represents the average number of 

people who are infected by each person having the disease. The Ro for smallpox is estimated as 

5 to 7.21 For example, with an Ro of 6, if 1,000 people initially became sick from a smallpox attack, 

they could infect 6,000 others, and those 6,000 could infect 36,000, and so forth—the secondary 

and tertiary infections would, of course, occur over time. But if the Ro were 15 (true for diseases 

like Pertussis and measles), a first generation of 1,000 cases could swell to 15,000 cases in the 

second generation and to 225,000 cases in the third generation in a heavily populated area 

unless there was an intervention in the form of treatment, vaccination, isolation of the infected, or 

quarantine. 

Physical Effects After Infection. As the result of an anthrax attack, some of those exposed 

would develop inhalation anthrax (quite deadly), and some would develop cutaneous (through the 

skin) anthrax (less deadly). By three or four days after the attack, many people would be sick, and 

 

20 Steve Fetter, “Ballistic Missiles and Weapons of Mass Destruction,” International Security, Summer 1991, 

pp. 25–26. 

21 See W. Orenstein, Director of the National Immunization Program, “Introduction to Smallpox,” briefing for 

the Centers for Disease Control. Available at http://www.bt.cdc.gov/agent/smallpox/overview/intro-tosmallpox.pdf. 
50 

7

some of those sick would be dying. By day 10, roughly 60 percent of those exposed would be 

dead unless effectively treated with antibiotics. Even if treated with antibiotics, many of the 

survivors of an anthrax attack could suffer debilitating chronic illness. A study done at the end of 

2002 examined 15 of the 16 victims of the anthrax letters mailed in 2001. The study found: 

“...that the infected adults experienced physical ills, psychological distress and a 

reduced quality of life. They had chronic coughs, fatigue, joint swelling and pain 

and memory loss, and suffered from depression, anxiety, obsessive-compulsive 

disorders and displays of hostility, researchers found.͒͒Survivors who had 

inhaled anthrax suffered worse health problems than those who became ill 

through skin contact with the biological agent. Eight of the study participants had 

not returned to work by December 2002, more than a year after anthrax was 

delivered by mail to Washington, New York and other areas....”22 

Protracted Incapacitation. In the 1960s, the U.S. offensive biological weapons program pursued 

nonlethal, incapacitating agents. The U.S. program reportedly focused on a cocktail of SEB, VEE, 

and Q-Fever,23 each having different incubation and effects periods. This cocktail would have led 

to the SEB toxin affecting people in roughly 3 to 12 hours and incapacitating them for a week or 

so.24 Before the SEB effects would fully wear off, VEE would make people sick, and as the VEE 

effects wore off, Q-Fever would make people sick. The illness from each of these diseases can 

be incapacitating, keeping many people from performing their missions for a month or more, 

though relatively few people would die. 

Other Effects. While the casualties caused by biological weapons are a concern, biological 

weapons would have many other effects. These include: 

x Loss of facilities. In the aftermath of the 2001 anthrax letters, it took months to several 

years to fully decontaminate the facilities where anthrax had been spread, and those 

facilities were not used until decontamination was completed. Most biological weapons 

decay within hours to days of their release, but some, like anthrax, can persist 

indefinitely. 

 

22 Only five of the 16 survivors had inhalation anthrax. Chris Schneidmiller, “Anthrax Survivors Suffered 

Long-Term Effects, Study Finds,” Global Security Newswire, April 28, 2004. 

23 Judith Miller, Stephen Engelberg, and William Broad, Germs: Biological Weapons and Americas Secret 

War, (New York: Simon and Schuster), 2001, pp. 56–57. 24 Some in the infectious disease community debate the ability of SEB to incapacitate for very long. The US 

military’s official reference book says: “Although an aerosolized SEB toxin weapon would not likely produce 

significant mortality, it could render 80 percent or more of exposed personnel clinically ill and unable to 

perform their mission for 1-2 weeks.” USAMRIID’s Medical Management of Biological Casualties Handbook, 

USAMRIID, 5th Edition, August 2004, p. 93. 
51 

8

x Medical care. A large number of persons sick from biological weapons could overwhelm 

the medical care system. In addition, many people who were not sick would be diverted 

from their normal activities to help sick family members or friends obtain medical care. 

And there is a tendency of uninfected persons to perceive that they have been infected, 

constituting a so-called “worried well” population. In the aftermath of the terrorist use of 

the chemical weapon Sarin in Tokyo in 1995, the number of “worried well” people who 

sought hospital care (many because of acute anxiety that caused physical symptoms) 

was three times the number of people who actually had physical symptoms of chemical 

exposure.25

x Biological weapon protection. Once the symptoms of biological weapons began to 

develop somewhere, people throughout the area would seek protective measures. With 

biological weapons, that would imply the use of at least a surgical mask, though P-95 

respirators would provide better protection against biological weapons. These protective 

measures would impose some degree of degradation in people’s actions, especially as 

they avoid physical activities that could break the seal on their masks. 

x Psychological reactions. Biological weapon use would cause severe psychological 

reactions in some percentage of the population in addition to the “worried well” problem. 

For example, during the 1994 natural plague outbreak in Surat, India, some 600,000 

people fled the city in one night, responding to 5,000 reported plague cases, of which 

only 167 cases were confirmed.26

Societal Effects in the ROK. Biological weapons can cause these and other strategic impacts, 

as illustrated in Figure 1. Thus the civilian casualties and loss of infrastructure from biological 

contamination could significantly impact a nation’s economy. Especially if contagious biological 

weapons were used, many trading partners would refuse to send their goods to the affected 

country and more likely would not accept goods from the affected country, fearing that the goods 

could be contaminated. There would also be the fear of new biological weapon attacks, 

particularly against those countries “helping” the country that was initially attacked. The country 

affected by biological weapons could also suffer international isolation. For example, during the 

1972 outbreak of smallpox in Kosovo, neighboring nations closed their borders with Yugoslavia.27

There could also be second- and third-order effects if health care and other resources were 

 

25 Rosalee Meyer, The Psychological Effects of a Chemical Attack on Military and Civilian Personnel, 

Battelle Memorial Institute, January 2003, section 3.2.3. 

26 V. Ramalingaswami, “Psychosocial Effects of the 1994 Plague Outbreak in Surat, India,” Military 

Medicine, Vol. 166, Supplement 2, December 2001, pp. 29–30. 27 D.A. Henderson, “Bioterrorism as a Public Health Threat,” Emerging Infectious Diseases, Vol. 4, No. 3, 

July–September 1998, p. 490, at http://wwwnc.cdc.gov/eid/article/4/3/pdfs/98-0340.pdf. 
52 

9

insufficient to meet demands. Much of the military could be diverted to sustaining internal order 

and/or imposing quarantine and vaccination requirements.28 In Korea’s case, the ROK could even 

find itself unable to carry out a counteroffensive into North Korea or to deal with a failed 

government in North Korea, being fully absorbed with internal problems and losing the economic 

resources to cover the costs of unification. 

Figure 1 

Potential Strategic Impacts of Biological Weapon Use 

 

To illustrate the potential challenges, consider the terrorist attacks on the United States that 

occurred on September 11, 2001. In those attacks, the United States lost less than 0.002 percent 

of its population, but various estimates put the loss of gross domestic product that year due to the 

attack in the 1 to 5 percent range. If the economic impact of such events can be hundreds of 

times the casualty percentage impact, consider the implications of biological attacks that would 

affect, say, 100,000 people in the ROK, or about 0.2% of the population. 

 

28 After an outbreak of smallpox in Kosovo in 1972, “Health authorities launched a nationwide vaccination 

campaign. Mass vaccination clinics were held, and checkpoints along roads were established to examine 

vaccination certificates. Twenty million persons were vaccinated. Hotels and residential apartments were 

taken over, cordoned off by the military, and all known contacts of cases were forced into these centers 

under military guard. Some 10,000 persons spent 2 weeks or more in isolation.” In that outbreak, there were 

a total of 175 cases of smallpox. Ibid. 
53 

10

Preparing for and Responding to Biological Weapon Attacks 

North Korea’s apparent development and testing of biological weapons on certain members of its 

own population suggests that the ROK needs to be prepared for North Korean biological weapon 

use against the ROK. Indeed, while there have been no proven North Korean uses of BW against 

the ROK, North Korea may have experimented with small amounts of endemic biological agents, 

like dysentery, to assess the ROK’s ability to detect biological agents use and manage the 

consequences of that use.29 It is clearly important to identify the means for countering North 

Korean biological weapon use. 

There are many ways to respond to the North Korean biological weapon threat. At the strategic 

level, it is best to deter North Korean biological weapon use. But deterrence rests squarely on 

being able to deny North Korea the effective use of biological weapons. Denial capabilities also 

provide the means to defeat biological weapon use. The plan for defeating North Korean 

biological weapons must focus on preventing the delivery of biological weapons against the ROK, 

detecting the presence of biological weapon agents or disease, preventing exposure to biological 

weapons, preparing people physiologically to prevent biological weapon infection, and handling 

the consequences of biological weapon use.30 

Preventing the Delivery of Biological Weapons. North Korea may attempt to deliver biological 

weapons in a number of ways. The ROK must be prepared to intercept each of these delivery 

methods. A failure to protect against any option makes North Korean use of that option more 

likely. The first step in interception is to detect any delivery systems carrying biological weapons, 

followed by efforts to intercept those delivery means. 

North Korean use of special forces to deliver biological weapons seems most likely.31 The 

technology involved is fairly simple, and North Korea has a large number of special forces who 

would want such empowerment. The special forces would seek to covertly deliver biological 

weapons against the ROK before the start of a conflict, making their actions difficult to detect. 

One intercept opportunity is at the ROK border, where ROK immigration should be connected to 

 

29 This point was suggested by a senior ROK military officer several years ago. 

30 In theory, the ROK could also destroy the North Korean biological weapons in their storage sites or other 

areas in North Korea before the weapons are used. But such efforts are beyond the scope of my testimony 

today. 

31 The North Korean military culture is important to understand. The founder of North Korea, Kim Il-Song, felt 

he had served as a special forces operator against the Japanese. He thus gave priority to special forces 

capabilities, as did his son, Kim Jong-Il. Biological weapons would significantly empower special forces,

consistent with this culture. 
54 

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the passport databases of its Asian neighbors and able to identify a falsified passport (since North 

Korean special forces are unlikely to enter the ROK on North Korean passports). 

Inside the ROK, organizations that have the ability to spray in broad areas (such as crop dusters 

or commercial pest control organizations) should be periodically examined to discern any 

connections to North Korean culture or groups. Suspicious behavior such as spraying outside of 

normal seasons or in unexpected areas should be investigated. 

It would be relatively easy to detect North Korean military aircraft or missiles that might be 

carrying biological weapons. The interception of aircraft would be easier than the interception of 

missiles. When possible, the ROK and/or the United States should destroy the North Korean 

delivery means over North Korean territory, as some of the biological weapons would likely 

survive interception and reach the earth’s surface. 

Detecting the Presence of Biological Weapon Agents or Disease. Protections against 

biological weapon agents are difficult and expensive to sustain; they are usually relaxed when an 

immediate threat is not perceived. Detecting the presence of a biological weapon agent is 

therefore critical to significantly enhancing the level of protection in a timely manner. Identification 

of the agent’s use is also critical to appropriately treating those infected. 

Detection can be done in several ways. First, a biological weapon agent can be detected by 

sampling the environment, including air, water, and food. Because U.S. military facilities, 

including those in Korea, would be likely targets of biological weapon attacks32 if North Korea was 

preparing for a major war, air sampling is done continuously around some bases with a system 

called portal shield, which can provide warning of a biological weapon attack. The ROK also has 

means for detecting biological weapon attacks. 

An alternative detection approach is disease surveillance. Typically performed in a hospital 

setting, this procedure is applied to people with flu-like symptoms to determine what disease they 

have contracted. If the disease is determined to be a potential biological weapon agent, detection 

provides warning unless the disease is endemic to that area, in which case local health 

authorities must look for other cases to determine whether the disease development is normal or 

reflects an unusual pattern that could have resulted from a biological attack. The ROK and U.S. 

authorities in Korea have developed good, well-coordinated disease surveillance. 

 

32 For example, North Korea cannot defeat US/ROK combat aircraft in the air. The North must instead attack 

them on the ground, and biological weapons would give them an option for doing so. 
55 

12

Preventing Exposure to Biological Weapons. There are various ways to prevent exposure to 

biological weapons once they have been used. One primary approach is to stop the movement 

into or out of areas where BW contamination is known to exist. Another approach used after the 

2001 anthrax letter attacks involved closing the buildings where exposure occurred until they 

could be decontaminated. 

Because many biological agents decay rapidly, decontamination will not be required after all 

biological weapon attacks. But with diseases like anthrax, decontamination is required due to the 

length of time that the agent can survive and remain a threat. Decontamination of most biological 

agents can be done with anything that kills biological agents, though with spores like anthrax, a 

more complex decontamination protocol is required. The ROK and the United States can likely 

handle selective decontamination in the ROK but would have problems handling many buildings 

or large areas. 

With contagious diseases, exposure can be prevented in various ways, as illustrated by the 1972 

smallpox outbreak in Yugoslavia. Neighboring countries closed their borders with Yugoslavia until 

the spread of the disease was under control. Also, schools can be closed and public activities 

suspended.33 Those infected with a contagious disease should be physically isolated from healthy 

people as long as they are contagious. And those who may have had contact with the infected 

can be put into quarantine for the incubation period of the disease to make sure they do not 

develop the disease.34 The ROK and the United States are not well prepared to implement 

isolation and quarantine in Korea or in the United States, generally lacking the laws and plans for 

such efforts. 

Another approach was applied during the SARS outbreak in 2002–2003 (and subsequently), in 

which people arriving by aircraft in some countries (including the ROK) were (and are) scanned 

for a fever to determine if they had been infected with some disease,35 and if so, they were 

isolated until their fever subsided or further testing determined that the cause of their illness was 

not threatening. 

Preventing Biological Weapon Infection. There are also several ways to prevent infection. 

Vaccines improve the individual immunity to a disease and are usually sufficient to prevent 

disease development during their effective period. Unfortunately, despite the long list of potential 

 

33 F. Fenner, D. A. Henderson, I. Arita, Z. Jezek, I. D. Ladnyi, Smallpox and its Eradication, (Geneva: World 

Health Organization, 1988), p. 1093. 

34 As noted in an earlier footnote, during the 1972 Yugoslavian smallpox outbreak, “Some 10,000 persons 

spent 2 weeks or more in isolation [quarantine].” D. A. Henderson, op. cit. 35 Some countries still scan all arriving visitors to determine if they have a temperature. 
56 

13

biological agents in Table 1, current vaccines are disease-specific. Of these agents, the U.S. 

military focuses its preventative measures on anthrax and smallpox because of the severity of the 

threat they pose. 

Vaccines can also be effective in preventing the spread of contagious disease. For example, the 

use of smallpox vaccine eventually led to the eradication of natural smallpox. The spread of 

contagious disease can be controlled through vaccination by reducing the rate of disease 

transmission to less than one person per previously infected individual. The level of vaccination 

required to stop disease spread is referred to as “herd immunity,” and equals: (Ro – 1)/Ro. Thus, if 

the smallpox Ro value is 6, herd immunity would require vaccinating about 83 percent of the 

population,36 especially in the geographic area around the infection. In the years during the 

eradication of smallpox, most countries achieved herd immunity levels of vaccination or more. 

However, since the late-1970s, almost none of the world population has been vaccinated, making 

it vulnerable to smallpox. To be prepared against North Korea’s use of smallpox, the Korea 

Centers for Disease Control (KCDC) acquired 7 million doses of smallpox vaccine, not enough to 

cover the entire country (just 15 percent of the population), but hopefully enough to cover the 

area where the disease breaks out if disease spread is contained. But the media has reported 

that the smallpox vaccines acquired by the ROK “...have either expired or failed to pass toxicity 

tests.”37 

It is worth noting that vaccines are not always assured protection. For example, the individual 

who was the source of the 1972 smallpox outbreak in Yugoslavia had been vaccinated for 

smallpox two months before he went to Iraq, where he was apparently exposed to smallpox. But 

the vaccine only suppressed his symptoms, preventing him from developing the kind of rash that 

usually leads to a prompt clinical diagnosis of smallpox. As a result, 11 people who had contact 

with him after he returned to Yugoslavia developed the disease, while medical officials were 

unaware that he was suffering from smallpox.38

Another way to prevent infection is through the use of face masks to block inhalation of a 

biological weapon agent. Surgical masks are typically used for this purpose, but they provide 

inadequate protection because some air can move around the mask. Respirators provide better 

protection, as they create a degree of seal with the face. The ROK should have in supply tens of 

 

36 In practice, the required level of smallpox vaccination appears to be less than this herd immunity value. 

See W. Orenstein, op. cit. 37 Robert Lee, “Smallpox vaccines against N.K. attack unusable,” The Korea Herald, September 7, 2011, at 

http://www.koreaherald.com/national/Detail.jsp?newsMLId=20110907000602. 

38 F. Fenner, op. cit., p. 1092. 
57 

14

millions of P-95 respirators, and the U.S. military in Korea should have tens of thousands of such 

respirators to be used in areas where full chemical masks are not required. 

Some diseases can also affect people through the eyes or through cuts in the skin,39 and thus 

precaution must be taken for broader protection against those diseases. This can be done with a 

typical chemical agent face mask, but the use of such a mask significantly impacts the 

performance of individuals, and few people other than the military have such masks in the ROK. 

Also, some diseases are carried by mosquitos, fleas, or other insects. With such diseases, action 

needs to be taken to protect people from those vectors and reduce the vector population. 

Another way to prevent infection is through collective protection that can be added to a facility. 

Such a collective protection system filters all incoming air, preventing most or all biological 

weapon agents from entering the facility. The facility needs to maintain a degree of overpressure 

that keeps air from coming in when people enter. Facilities also need a means for 

decontaminating people as they enter to prevent them from bringing in the biological weapon 

agent on their clothes or bodies. It does not appear that there are many such protected facilities 

in the ROK—more efforts in this area are required and hopefully will be taken as U.S. facilities are 

built at Camp Humphreys.40

Treating the Consequences of Biological Weapon Use. Once it is known that a biological 

agent has been used, and the agent has been identified, medical treatment can focus on 

countering that agent. As noted above, with bacterial agents, some form of antibiotic can be used 

to treat the victims. In practice, treatment of the inhalation anthrax victims in 2001 employed a 

mixture of antibiotics to increase the chances of success.41 While the ROK likely has a good 

supply of antibiotics for everyday use, it likely has far less than would be demanded by those who 

are sick and the “worried well” in the aftermath of a major biological weapon attack. 

Against viruses, antivirals offer the possibility of countering the diseases (antivirals do not always 

work against all viruses). Where vaccines are available, they may also be useful in treatment, 

especially in that of people who have been exposed but are not yet symptomatic.42 The ROK 

 

39 For example, percutaneous anthrax infections can become serious at cuts in the skin. 

40 Buildings with collective protection potential were built at the U.S. Osan Air Force Base in Korea. 41 John A. Jernigan, et. al., “Bioterrorism-Related Inhalational Anthrax: The First 10 Cases Reported in the 

United States,” Emerging Infectious Diseases, Vol. 7, No. 6, November-December 2001. 42 For example, the smallpox vaccine is considered very useful especially during the first five days after 

exposure. Even if it does not prevent the disease from developing, it tends to produce a more mild case of 

the disease. D.A. Henderson, “Smallpox as a Biological Weapon: Medical and Public Health Management,” 

Journal of the American Medical Association, Vol. 281, No. 22, June 9, 1999, p. 2132. 
58 

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does not appear to have large stockpiles of antivirals; both the United States and the ROK should 

assure the ability to treat large parts of their populations in Korea for many days. 

Finally, with regard to toxins, an agent-specific antitoxin is required. There are relatively few kinds 

of antitoxins that have been developed, and they are available only in small quantities in most 

countries, in part because of their cost. 

As suggested in the discussion of the effects of biological weapon attacks, the inability to treat 

people exposed to biological weapons could lead to very high numbers of casualties and many 

deaths. The ROK should thus seek to participate in the development of new vaccines and 

treatments, an area in which the United States appears to be making some progress.43

Managing Human Remains. Many biological weapon attacks will lead to fatalities. Because 

some diseases (especially ones that are contagious) will remain a threat inside infected cadavers 

for a period of time, cremation of the dead is often recommended to prevent further spread of the 

disease. If cremation is not practiced, the body should be contained in some way (e.g., the use of 

a body bag and a sealed coffin) to prevent disease spread. It is unlikely that sufficient supplies of 

containment items exist in the ROK. 

Conclusions 

North Korean biological weapons could pose serious threats to the ROK, other countries in 

Northeast Asia, and the United States. The exact nature of the North Korean biological weapon 

threat is not known, but a variety of serious biological weapons agents may have been developed 

by North Korea, and North Korea is also reported to have experimented on political prisoners with 

some of these agents. While it is therefore difficult to determine when or how North Korea would 

use biological weapons, any such use could cause many casualties and be highly disruptive to 

ROK and even U.S. society. 

The ROK and the United States have made efforts to prepare for biological weapon attacks and 

be ready to respond to them. Given adequate ROK/U.S. preparations, North Korean biological 

weapon attacks will hopefully remain deterred. But such preparations are technologically 

challenging and costly, and much more can be done. If assessments of North Korean capability 

 

43 “A significant number of experimental vaccines and other drugs for treating people exposed to biological 

weapons agents are due within a half-decade to undergo federal assessment, a U.S. Health and Human 

Services Department office said in a five-year plan issued on Tuesday.” “Bioweapon Countermeasure 

Progress Seen Within Half-Decade,” Nuclear Threat Initiative, October 7, 2011, at 

http://gsn.nti.org/gsn/nw_20111006_4385.php. 
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are correct (or if North Korean capability is even at the mid-point of these estimates), then the 

following recommendations should be pursued: 

x The ROK and U.S. governments should protect themselves against the delivery of 

biological weapons. In peacetime, their immigration authorities should link to the passport 

databases of Northeast Asian countries in order to aid in the identification of forged 

passports that North Korean agents would be using to carry BW into the ROK or the 

United States. In crisis and war, the ROK and U.S. militaries should be better prepared to 

detect and intercept North Korean aircraft and missiles. 

x The ROK and U.S. governments should detect and attribute biological weapon attacks 

and identify the biological weapon agents used. They should pursue research to better 

perform these tasks. 

x The ROK and U.S. governments should prevent exposure to and infection with biological 

weapons and be ready to deal with the consequences of biological weapon infection. 

They should prepare to close or closely regulate borders, close schools and other venues 

where disease spread is expected, impose isolation on those with contagious disease 

and the quarantine of those potentially exposed, and decontaminate infected areas when 

necessary. They should make sure the legal basis for these actions is in place and 

provide for the personnel needed to perform these functions. And they should pursue 

cooperative research on potentially needed vaccines and treatments and acquire 

appropriate amounts of such vaccines and treatments. 

Chairman Thornberry, Ranking Member Langevin, and members of the Subcommittee, thank you 

again for inviting me to testify before you today. I look forward to taking your questions. 
60 

Bruce W. Bennett is a senior defense analyst at The 

RAND Corporation. He specializes in strategy

formulation, force requirements, and responding to 

“asymmetric threats” such as weapons of mass

destruction (WMD). His work applies deterrence-based 

strategy, competitive strategies, risk management, 

military simulation and analysis, and war gaming. He has

examined the operational/strategic implications of 

possible chemical, biological, and nuclear threats, 

including nontraditional agents, posed in the United

States, Northeast Asia, and the Persian Gulf. His most recent project is working with 

the operational commanders in Korea to examine force requirements for WMD 

elimination. He previously supported the US Pacific Command and the US Forces

Korea in designing and moderating the Coral Breeze exercises (on chemical and 

biological agent threats) and the biological weapons countermeasures initiative.

He is an expert in Northeast Asian military issues, having visited the region some 

90 times and written much about Korean security issues. His regional research has

addressed issues such as deterrence of North Korean threats, the North Korean weapons

of mass destruction threats and how to counter them, future Korean military force

requirements, the Korean military balance, and dealing with a North Korean government 

collapse. He recently completed a book on “Preparing for the Possibility of North Korean

Collapse.”

At RAND, Dr. Bennett has worked with the Office of the Secretary of Defense, the 

Defense Threat Reduction Agency, the U.S. Army, the U.S. Air Force, the U.S. Pacific

Command and Central Command, U.S. Forces Korea and Japan, the South Korean and

Japanese militaries, and the South Korean National Assembly. 

Dr. Bennett received a Ph.D. in policy analysis from the Pardee RAND Graduate

School and a B.S. in economics from the California Institute of Technology. 
61 

Statement of Major General (ret.) Philip K. Russell, MD 

Before 

The House Armed services Committee 

Subcommittee on Intelligence, Emerging Threats, and Capabilities 

October 11, 2013 

Mr. Chairman, members of the committee, thank you for inviting me to discuss problems with the 

preparedness of our armed forces to deal with the threats posed by biological weapons. It is a problem 

that I have been deeply concerned about for over thirty years, first as an Army Medical Corps officer and 

later at Department of Health and Human Services. During my government career, I have had the 

privilege of managing the development of several vaccines, antitoxins and other medical 

countermeasures for both biodefense and public health purposes. 

In this testimony I would like to make two points. First, the threat that a biologic attack by terrorists or 

other adversaries poses to our armed forces or our nation is not fully understood or recognized by the 

leadership of our defensive programs. Second, the medical countermeasure development programs of 

the Department of Defense essential to protecting our armed forces and our nation have a long, very 

well documented, record of failure and will continue to fail if no corrective actions are taken. 

The first point is based on three in depth studies of the achievements of U.S. offensive biowarfare 

program which was terminated in 1969 and on analysis of the impact of the technical progress made in 

recent years by the pharmaceutical industry in terms of the potential capability it provides to our 

adversaries. These studies, which were conducted by Mr. Joel McCleary, Dr. Keith Wells and myself over 

the past two years, are based on the existing unclassified documents concerning the former US program 

and on the oral history of one of its last surviving senior scientific leaders. We also looked at how the 

advances in biologic manufacturing, bioprocessing, stabilization methods, spray drying and lyophization 

can be utilized by bioterrorists to produce weapons as effective as those produced by offensive 

programs of the US and the Soviet Union. Results of these studies have been provided in briefings to 

members of the intelligence community and to key personnel in the Departments of Homeland Security, 

Defense, and Human and Health Services. 

 The most significant finding of these studies was that, after years of research and testing the most 

effective agents chosen for use as strategic offensive weapons, were tularemia and staphylococcal 

enterotoxin B (SEB). Plans and equipment were made to use these agents in combination. The bacteria 

was chosen for its lethality and the toxin for its rapid incapacitation. Extensive field tests including “Red 
62 

Cloud,” “Watch Dog,” and “Speckled Start” proved that these agents used as dry powder aerosols could 

deliver very high doses over large areas.. Tularemia is one of the most infectious agents known; the 

human infectious dose determined by studies in volunteers is less that 10 bacteria. It can be grown in 

culture in a fermenter to concentration of 1011 bacteria per ml. A dry powder aerosol can deliver 

hundreds of thousands of organisms to exposed personnel. Recent studies in monkeys conducted by 

the Lovelace Institute have proven that very high doses delivered by aerosol cause a devastating 

pneumonia with a very short incubation period making post-attack therapeutic treatments with 

antibiotics problematic. Virulent strains of tularemia are readily found in nature. SEB was chosen 

because is a fast acting incapacitating agent when delivered by aerosol. It causes a pneumonitis and is 

lethal at high doses. It is stable and relatively easy to produce in culture. High producing strains are 

widespread and easily found. 

The offensive program created very effective strategic weapons but needed industrial level capability to 

manufacture the weapons they tested and stockpiled. However advances since 1969 in technology now 

put this capability within reach of any nation state or small number of dedicated terrorists. The 

pharmaceutical industry in the course of developing delivery of multiple drugs by aerosol and refining 

biologics manufacturing processes has created the technology and equipment to make bioweapons 

much more readily available. The information on the new processes is widely published in the public 

domain and the equipment is available for sale and resale on the internet. The obstacles that the former 

U.S. offensive program had to overcome such as stability and uniform particle size have been mitigated 

by modern technology. Our conclusions in regard to the ability of motivated terrorist group to exploit 

modern technology to achieve what was once only a state weapon’s monopoly is accepted without 

reservation by the leading technical experts in our intelligence community. 

The accomplishments of the offensive programs of the U.S. and the Soviet Union have largely been 

forgotten or ignored by policy makers and product developers. Consequently, there is no specific 

licensed preventive medical countermeasure available for either of the leading lethal agents of the US 

offensive program, tularemia or SEB. We rely on antibiotics to deal with tularemia post-exposure and on 

supportive medical care for SEB. This is an unaddressed national vulnerability. 

The Department of Defense created a joint program for advanced development medical 

countermeasures in 1996. The Join Vaccine Acquisition Program (JVAP) was a major component. A 

tularemia vaccine was at the top of the requirements list which included several other biodefense 

vaccines. It is now seventeen years later and no new licensed products have been developed. The 

deficiencies in our national level of preparedness have been described in detail by the Commission on 

the Prevention off Weapons of Mass Destruction, Proliferation and Terrorism chaired by Senators 

Graham and Talent and by the “Bioresponse Report Card” issued by the Bipartisan WMD Terrorism 

Research Center. 

The Department of Defense efforts to develop vaccines have been reviewed and criticized by several 

independent groups. The “Top Report”, a Report to the Deputy Secretary of Defense by an Independent 

Panel of Experts concluded in 2000 that the program is “insufficient and will fail”. Reports by 

committees of the Institute of Medicine in 2002 and 2004 documented the program failures, criticized 
63 

the management of the program, and made recommendations for change. The National Biodefense 

Science Board addressed the issue of lack of countermeasures in 2010. These external independent 

advisory groups have had no impact on the program. 

Since the origin of the DoD program billions of dollars have been spent. Yet only two vaccines, a plague 

vaccine and a botulism vaccine, are in advanced stages of development. The attempts to develop an 

early live attenuated tularemia vaccine to licensure have failed and no significant progress on a second 

generation product is evident. The problems with the program are detailed in multiple reports. 

Problems include the DoD contracting mechanisms, which are largely unsuited to working with the 

vaccine industry, lack of knowledge of the vaccine industry by program managers, and reliance on prime 

contractors with limited capability. Uncertain funding disrupts programs and, most importantly, lack of 

accountability by the leadership allows failure to continue. 

There is some good news. The basic research programs at USAMRIID continue to be very productive and 

are creating the scientific basis and early prototypes for several vaccines including the hemorrhagic 

fever and encephalitis viruses. 

In summary, lack of understanding of the threat that the strategic bioweapons produced by the U.S. 

program continue to pose a major threat coupled with an ineffective countermeasure development 

program has created a significant vulnerability for our Armed Services and our nation . 

 
64 

Philip K. Runell. M.p. 

Retired MajorGene<al Philip K. Russell. M.D. &aMId in the U.S. Atmy Medical Corps from 1959 to 1990. 

pursuing a career in Infectious disease and tropical medicine research. 

FoIloIOIiog his 1r.Wling in inlernal medicine, he assumed a suc:cnsion of raseareh assignments at the 

Waller Reed Atmy Institute 01 Researeh and 0¥eI"S0!3S laboralories in Pakistan. Thailand, and Voelnam. 

He co;tIducted laboratory and clinical research on a Yilriety of WaI and parasitic fnfactious disa_. 

incIudiog o:Iengue, malaria, hepatitis, and respifaIofy Yin.osas. 

Rus.sell authored Of co-auU1ofed more!h.9n 100 research publications and contribuled 10 the successful 

deveIQpment of several vaccines important to the military and public health, including those of 

iIde!>oYirus, rnerW!gitis, and hepatitis A and B. later, as dinlctor 01 the Walter Reed Atmy Institute 01 

ReseiIrch. he led research on V8CCines \IIIiIinst o:Iengue and malaria. As commander 01 the U.S. Army 

Medical Research and DeYeIopment Command, he SpeaIII>eacled • major effort to increase the capabilily 

01 the armed forces to defend again$! bi(qical agents. His military fi3rds i-du<Ie \he legion of Merit 

and the Oistinguiahed Sefvioe Medal 

FoIloIOIiog his m~itary seMce, Russelljoined..k:>hns Hopkins U~s School of Hygiene and Public 

Healltl as professor of intemalioniol heaI!h and worI<ed cIo5aIy with the Wor1d Health Organilalion as 

spaci811KMsor to the Children's Vaccine InitiaIMI. He was founding board member 01 the Intematiorlal 

AIDS Vaccine InitiaIMI. After beooming professoremerilus in 1997, he serwd as an adYisorlO the Bin 

.nd Melinda Gates Foundation as wi as seYe!BI vaccine programs and was instrumental in CtMIing the 

Malaria Vaccine Initiative. 

Russell na~ served on nu""'"""" advisory boartls 01' natkInaI and inlemlltlonill ~, Induding the 

centers fOI' Disease Control, Nation Institutes of Healltl and the IfI5litu1a of Medicille, He served on the 

Boards of Directcn 01 the IJIIemaOOnaI Vaccine IlI5Iitute, the Aeras FOUIIdation, and the Albert B. Sabin 

Vaccine Institute. Following the anltlrax at\aI':k$ in 2001, Russell led B Department 01 Health and Humen 

ServIces effort to develop and stockpile vaccines and 0Ihef medical OOUl'I\em'IeasUres against 

bio\errori$m agents. He continues 10 WOI1< on the t 01 vaeeInes fOI' !he deveIopiog world. 
65 

1

HEARING BEFORE THE ARMED SERVICES COMMITTEE 

SUBCOMMITTEE ON INTELLIGENCE, 

EMERGING THREATS AND CAPABILITIES 

U.S. HOUSE OF REPRESENTATIVES 

“Biodefense: Worldwide Threats and Countermeasure Efforts 

for the Department of Defense” 

October 11, 2013 

Brett P. Giroir, M.D. 

Interim Executive Vice President and CEO 

Texas A&M Health Science Center 

Chairman Thornberry, Ranking Member Langevin, and members of the committee, thank you for the 

opportunity to be here today. I appreciate the opportunity to discuss government efforts and 

opportunities for collaboration to address our nation’s biodefense priorities. 

I am currently the Interim Executive Vice President and CEO of the Texas A&M Health Science 

Center and Principal Investigator for the Texas A&M Center for Innovation in Advanced 

Development and Manufacturing, a public-private partnership with the U.S. Department of Health 

and Human Services designed to enhance the nation’s emergency preparedness against emerging 

infectious diseases. 

My pathway to this position includes a career as an academic physician scientist, focusing on life 

threatening infectious diseases, particularly those diseases affecting adolescents and young adults. 

As a result of work in this field, I was invited to serve on one of DARPA’s non-governmental science 

and technology assessment panels, the Defense Sciences Research Council (DSRC), which was 

responsible for developing concepts that could potentially lead to DARPA initiatives and “gamechanging” capabilities benefitting national security. In this role, I chaired or co-chaired numerous 

intensive studies on chemical, biological, radiological, and nuclear (CBRN) security and 

countermeasures, decontamination, and warfighter performance under extreme conditions. 

After five years on the DSRC, I was privileged to serve as Deputy Director, and then Director, of the 

Defense Sciences Office at DARPA, and honored to be the first medical doctor to become an office 
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director in the 50 year history of that agency. In my role as Director, working with a 

multidisciplinary team of the nation’s finest scientists, physicians, and engineers, and with the 

budgetary opportunities provided to us by Congress, we developed and implemented an integrated 

platform of research initiatives, named Accelerating Critical Therapeutics (ACT), designed not only 

to provide new, highly effective medical countermeasure capabilities, but also to provide an 

unprecedented, flexible, adaptable, and rapid response to address and defeat the pervasive and 

growing threat of highly genetically modified or chimeric organisms for which the nation had no preexisting vaccines, countermeasures, or technical approaches. Many DARPA programs begun at that 

time are now operational and have made an enormous impact on our public health preparedness and 

response. 

One aspect of the portfolio that was extraordinarily challenging, even by DARPA standards, was the 

ability to develop low cost, highly flexible and adaptable manufacturing technologies capable of 

providing tens of millions of doses of vaccines or medical countermeasures (such as monoclonal 

antibodies or antidotes to chemical weapons) within weeks of notification. Such a capability did not 

exist in the civilian or military experience, and there were profound technical barriers to overcome. 

Among these barriers were traditional manufacturing facility architectures that were generally single 

use, and cost $1 billion or more. In addition, production platforms such as fertilized chicken eggs 

necessitated an enormous logistics tail, and therefore had very limited rapid response capabilities, 

even when heroic efforts were made by the U.S. Government and industry, as demonstrated in the 

2009 H1N1 pandemic. 

The concept of developing 21st century manufacturing capabilities had many champions, including 

DARPA and its technical assessment panels, leading academic groups such as the National Academy 

of Engineering and the University of Pittsburgh Medical Center, as well as many senior government 

officials including the President’s Special Assistant for Biosecurity. Nonetheless, there was no 

obvious mechanism to test and implement these concepts, because there were no U.S. Government 

programs in place, and the concepts were far too innovative and high risk to be adopted by the 

commercial biopharmaceutical industry. 
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Implementation of 21st Century Manufacturing and Response at Texas A&M 

The Texas A&M University System (TAMUS) is one of the largest systems of higher education in 

the nation, with a statewide network of 11 universities, seven state agencies, two service units and a 

comprehensive health science center. Led by Chancellor John Sharp, A&M System members 

educate more than 125,000 students and reach another 22 million people through service each year. 

With more than 28,000 faculty and staff, and a budget of approximately $3.8 billion annually, the 

A&M System has a physical presence in 250 of the state’s 254 counties and a programmatic presence 

in every one. In 2011, externally funded research expenditures exceeded $780 million making it one 

of the premier research and development institutions globally. 

In 2008, my assignment to DARPA was completed and I joined the Texas A&M System. Because 

the nation’s security against CBRN threats was dependent on the development of highly flexible and 

adaptive manufacturing technologies, and to protect the U.S. commercial industry and tens of 

thousands of domestic jobs, we assembled a core team of scientists and engineers to fully leverage 

Texas A&M’s robust resources and historical commitment to national service. Our mission was to 

perform the “proof of concept” breakthrough implementation of a flexible manufacturing facility that 

eventually could be the technological model for a national program. 

With the enthusiastic support of Texas Governor Rick Perry, the Texas A&M Regents, and 

Chancellors McKinney and Sharp, and with a $50 million investment from Texas Emerging 

Technology Fund, our team aimed to design, develop, build, and operate a facility and associated 

program that would demonstrate: 1) highly flexible, adaptable, mobile manufacturing architectures 

and platforms, 2) an unprecedented response capability against emerging and intentional threats, 

and 3) a capital cost at least 80% less than the current state of the art. We named the project the 

National Center for Therapeutics Manufacturing (NCTM). The NCTM is now the core facility and 

primary site for developing and manufacturing Medical Countermeasures and Vaccines against 

CBRN threats for the Texas A&M Center for Innovation. A full description of the NCTM is 

provided below. 
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Overview of the Department of Health and Human Services Texas A&M Center For 

Innovation in Advanced Development and Manufacturing (CIADM)

The Texas A&M CIADM is the most highly funded of three national centers competitively awarded 

by the Department of Health and Human Services in June 2012, and is the only Center led by an 

academic institution. It is founded on an initial $285.6 million public-private partnership, consisting 

of approximately $176 million committed investment by the HHS, and $109 million supplied as cost 

share by academic, commercial, and State of Texas stakeholders and collaborators. The Center is 

designed to enhance the nation’s preparedness and response against emerging infectious diseases, 

including pandemic influenza, and chemical, biological, radiological and nuclear threats. The Center 

will perform advanced research, facilitate development, ensure domestic manufacturing capacity, 

enable product FDA approval and mentor the next generation of public health professionals through 

education, training and outreach. The initial $285.6 million contract, over a five-and-one-half year 

base period, will result in the establishment of all capabilities required by the U.S. Government. In 

addition, there is a total potential contract duration of 25 years, including an additional >$2.4 billion 

in readiness and task order options that can be exercised at the discretion of the U.S. Government. 

The Center leverages over $200 million in prior investments by the Texas A&M University System 

and the State of Texas in facilities and programs dedicated to advanced development and 

manufacturing of biopharmaceuticals. The specific high level objectives of the Center are the 

following:

x Provide the strategic national vaccine response to pandemic influenza, defined as 50 million 

vaccine doses delivered to the U.S. Government within four months, with initial doses 

available in 12 weeks; 

x Research, develop, and manufacture vaccines and medical countermeasures to chemical, 

biological, radiological, and nuclear (CBRN) threats as requested by HHS; and 

x Train the U.S. national workforce in biopharmaceutical manufacturing, animal model 

development, biosecurityǦrelated clinical trials, and regulatory approval processes. 
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Subcontractors and Collaborators 

Texas A&M has assembled a multidisciplinary team of subcontractors with expertise that spans the 

spectrum of disciplines needed to achieve the objectives, including process development, flexible 

manufacturing, preclinical testing (including BSL3 and BSL4 capacity), clinical trials, quality 

assurance/control, and regulatory affairs. Key subcontractors include: 

x GlaxoSmithKline Vaccines (GSK): The world’s largest vaccine developer with 30+ vaccines 

marketed worldwide, 11 licensed by the FDA, and 1.4 billion doses distributed annually. 

GSK is providing the cell based pandemic influenza vaccine candidate, as well as their 

proprietary adjuvant technology, to TAMUS in order to meet the nation’s pandemic influenza 

vaccine surge requirements. 

x Kalon Biotherapeutics (Kalon): The commercial development and manufacturing 

organization (CDMO) founded and owned by Texas A&M and the State of Texas, which 

provides core process development and manufacturing services for CBRN vaccines and 

medical countermeasures. Kalon is also GSK’s development partner for its cell-based 

pandemic and seasonal influenza vaccines. Kalon staff includes former leaders from the 

global biopharmaceutical industry including Sanofi-Pasteur, Novartis, and Medimmune. 

These experienced professionals are already being supplemented by recent graduates from 

the Center’s workforce development program. 

x Other CIADM Partners include Lovelace Biomedical and Environmental Research Institute 

(non-profit research organization that conducts pre-clinical CBRN studies including nerve 

agents), UTMB-Galveston National Laboratory, Lonza (global pharmaceutical services 

company), Caliber Biotherapeutics (plant made vaccines and biopharmaceuticals), the Sabin 

Vaccine Institute at the Baylor College of Medicine (non-profit vaccine development 

institute), Sartorius (leading global bioprocess technology provider), and multiple Texas 

A&M System Components including the Texas A&M Institute for Preclinical Studies, the 

Texas A&M Engineering Experiment Station, Texas A&M University, and the Texas A&M 

Veterinary Diagnostic Laboratory. 
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x Collaborations: In addition to the above established partnerships, TAMUS has new 

collaborations with multiple entities focused on specific aspects of the CIADM, or related 

product development. Among these collaborations are confidential global pharmaceutical 

corporations, biotechnology companies, adult stem cell and cell therapeutics companies, the 

MD Anderson Cancer Center, and the University of Texas in Austin. 

Biomanufacturing Infrastructure 

The CIADM is leveraging pre-existing process development and manufacturing infrastructure at 

Texas A&M, but will also design, construct, and validate additional core facilities to supplement 

existing infrastructure. Among the key Center facilities now in design and/or construction are the 

following:

x National Center for Therapeutics Manufacturing (NCTM) 

Status: Operational and undergoing expansion and enhancement. All retrofit and upgrade 

activities are scheduled for completion by March 2014. 

The NCTM is a revolutionary, first-in-class, multi-product, multi-technology, 150,000 sq. ft. 

biopharmaceutical development and manufacturing facility. A key feature of the NCTM is 

the use of Modular Clear Rooms (MCRs), which are newly-developed, standalone, modular, 

mobile, self-contained and fault-tolerant biopharmaceutical clean rooms. The initial MCR 

concept was funded by the Department of Defense through DARPA and ARO. Through the 

NCTM project, TAMUS has developed, implemented, and validated novel bioprocess 

architectures that provide solutions for the commercial industry and the U.S. Government. 

These solutions include: the ability to accommodate multiple (up to six) simultaneous 

products up to the 1000 liter (L) scale in support of Phase I through Phase III clinical trials, 

as well as commercial manufacturing; flexibility to fundamentally rearrange, in near realtime, entire unit processes and clean room suites without disruption of simultaneous ongoing 

operations; the ability to surge multi-fold on a single product, within 24 hours, as needed to 

support biosecurity or commercial clinical needs. The NCTM also maintains limited fill and 
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finish capabilities primarily in support of clinical trials. 

The NCTM is being expanded, enhanced, and outfitted for large scale operations via the 

CIADM contract, including the provision of an additional eight MCRs. 

x Pandemic Influenza Vaccine Facility (PIF) 

Status: Design development completed; construction and initial facility commissioning are 

scheduled for completion by the 3rd quarter of 2015. 

The PIF will be a new, stand-alone, 100,000 sq. ft. facility designed to supply bulk antigen to 

meet the U.S. Government requirements for 50 million doses of pandemic influenza vaccine 

within four months, with the first doses supplied in twelve weeks. The PIF emphasizes the 

use of flexible, single use technologies, made possible by the highly advanced cell based 

production system from GSK. Within seven years, it is expected that the PIF will have no 

ongoing readiness costs charged to the U.S. Government, because it will also function as the 

licensed manufacturing facility for GSK’s cell based seasonal influenza vaccine for North 

America. When not supplying commercial or pandemic influenza vaccines, the PIF is 

available for production of other CBRN countermeasures, particularly monoclonal antibodies 

and therapeutic proteins. The PIF will be operated by Kalon in partnership with GSK. 

x Live Virus Vaccine Facility (LVVF) 

Status: Completed advanced schematic design, scheduled for completion of construction 

and commissioning by the 3rd quarter of 2015. 

The LVVF will be a new, stand-alone facility, adjacent to and synergistic with the PIF, 

dedicated to the process development and manufacture of live virus vaccines including 

products that require BSL-3 level biosafety. The LVVF will primarily focus on vaccines and 

countermeasures for biothreat agents, but also on commercial vaccines that utilize similar 

technologies. Live virus vaccines are emerging as a major platform technology for a variety 

of civilian diseases, including cancer. The current concept calls for an approximately 70,000 

sq. ft. facility utilizing a combination of fixed modular, and mobile modular (MCRs), and the 

ability to more than triple its initial capacity as demand for live virus vaccines increases in 
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the next decade. To reduce capital and operational costs, the LVVF will leverage core 

infrastructure, such as power and utilities, from the adjacent PIF. 

x Fill and Finish Facility 

Status: In phase of defining a program of requirements. 

This facility, to be located within the United States, will provide comprehensive large scale 

fill and finish capabilities for the CIADM as well as other government and commercial 

customers. The primary objective is to supply the CIADM with capability for fill and finish 

of live virus vaccines, to the level of two million vials per year. We also expect the facility to 

maintain additional capabilities including lyophilization for both viral and non-viral based 

vaccines. The operational partner for this program is currently under evaluation and 

selection by Texas A&M leadership team in collaboration with HHS. 

x Process Development Facility (PD Facility) 

Status: In concept design, scheduled for completion in early 2015. 

To expand on current PD capabilities, the CIADM will build a flexible PD capability 

designed to support a full range of manufacturing platforms and products, from microbial to 

insect cell and mammalian systems, and products ranging from personalized protein and 

DNA vaccines, to monoclonal antibodies and therapeutic proteins. 

x Caliber Biotherapeutics Facility 

Status: Completed and operational. 

Developed and built through a consortium comprised of Texas A&M and G-CON, LLC, and 

funded by the DARPA Blue Angel Program, the CIADM has partnered with Caliber 

Biotherapeutics to make available Caliber’s plant-made pharmaceutical facility for HHS task 

orders, including vaccines and monoclonal antibodies. The facility has the capability to 

produce up to 20 kg of purified protein per month through its highly automated, Nicotiana

benthamiana, plant-based production system; we consider this program to be the most 

responsive, secure, and capable plant-made vaccine program currently available worldwide. 
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Workforce Training 

The Texas A&M Engineering Experiment Station (TEES) and TEES subcontractors {(Baylor 

College of Medicine, Blinn College, and Texas A&M Engineering Extension Service (TEEX)}, are 

already providing comprehensive workforce training in all aspects of process development and 

biopharmaceutical manufacturing at the technical certificate level through post-graduate, professional 

training.

TEES has already performed a workforce needs assessment, established an advisory committee that 

includes multiple industry partners, developed preliminary curricula, begun training courses, and 

implemented an internship program with CIADM pharmaceutical partners. As an option to the US 

Government which may be exercised in the future, TEES and subcontractors will also provide 

training in preclinical models, including BSL-3 and BSL-4 procedures, as well as diagnostics and 

regulatory science. 

The workforce training program builds on a pre-existing program initiated by TEES under the 

sponsorship of the Texas Workforce Commission. TEES has also begun an innovative STEM 

summer initiative for high school students, primarily from historically underserved groups, aimed at 

developing a diverse, highly qualified work force. TEES completed is second summer program in 

2013, all self-funded by TEES, with remarkable successes in generating both strong interests as well 

as life-changing experiences for underserved students. It is hoped that the federal government will 

support such efforts aimed at underserved STEM education, and expand these programs nationally, 

to assure a future workforce that is both diverse and capable. 

Department of Defense Opportunities 

As a leading academic institution with a history of dedicated national service, TAMUS is highly 

motivated to leverage its capabilities to support the Department of Defense (DoD) requirements for 

CBRN vaccine and medical countermeasure development, manufacturing, licensure, and delivery to 

warfighters. In addition to pre-existing capabilities at TAMUS and its subcontractors, at least 50% of 

CIADM capabilities will also be available for non-HHS projects. As such, TAMUS has been 

independently monitoring and submitting proposals to DoD through open solicitations, including two 
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recent Requests for Information (RFI) seeking capabilities for the development and manufacturing of 

vaccines and therapeutics of interest to the DoD. 

Of particular interest to TAMUS is the exploration of partnerships within the LVVF and NCTM, as 

well as the Process Development facility, all of which could develop and manufacture DoD products 

for the stockpile, special immunization programs, as well as provide the basis for emergency 

response to “unknown unknowns” including genetically modified or chimeric organisms. The 

available Texas A&M capacity, which is already funded by HHS, would not only dramatically 

reduce operational risks, but would also substantially reduce DoD capital expenditures and 

operational costs. It is important to note that the HHS capacity is meant to serve 300 million 

civilians, so the addition of capacity for DoD personnel, staff and families could be easily 

accommodated. Moreover, the great majority of vaccines and countermeasures will be identical to 

those developed for civilians. 

There are several models for partnership that would provide priority for DoD needs over commercial 

or academic projects. Among these of high interest to TAMUS is a “civil reserve air fleet, or CRAF, 

model” in which the DoD reserves space with priority for an annual fee which can be applied to DoD 

task orders. 

By leveraging nearly $500 million in Texas, Texas A&M, and DHHS investments, we believe that 

the DoD could achieve its mission at low risk, minimal initial capital outlay, and easily sustained 

operational costs. Our preliminary estimates suggest that by utilizing the pre-existing and already 

funded capacity provided by HHS, the DoD can guarantee all the availability required, with 

substantially less risk, for ten years, at approximately half of the initial facility costs budgeted for a 

dedicated DoD facility. This would free up substantial resources that could be reallocated to provide 

additional vaccines, countermeasures, and capabilities to our warfighters. Furthermore, the colocation of HHS and DoD programs would enhance cooperation, reduce duplication, and increase the 

likelihood for enhanced quality and responsiveness. 

In conclusion, I believe the federal government’s current investment in biodefense and CBRN 

countermeasures, primarily through HHS, should be a focus for collaboration, risk reduction, and 

cost effectiveness for the DoD. Through the three recently awarded Centers for Innovation in 

Advanced Development and Manufacturing (ADM) , the nation now has the capacity to develop, 
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manufacture, and stockpile a wide array of medical countermeasures arising from diverse platforms. 

Better coordination and collaboration among the DoD, HHS, and these public-private partnerships 

would maximize the use of limited resources and provide a more efficient and productive return on 

the government’s overall investment in this critical area of national security. 
76 

 BIOGRAPHICAL SKETCH – BRETT P. GIROIR, M.D. PAGE 1 

Brett P. Giroir, M.D. 

Interim Executive Vice President 

Texas A&M Health Science Center 

Professor, College of Medicine, Texas A&M Health Science Center

Professor, Department of Biomedical Engineering, 

 Dwight Look College of Engineering 

 Adjunct Professor, Bush School of Government and Public Service 

 

(979) 436-9102 giroir@tamhsc.edu 

Dr. Brett Giroir assumed interim leadership of Texas A&M Health Science Center in October 

2013. The Texas A&M Health Science Center is a premier assembly of colleges devoted to 

educating health professionals and researchers that seeks to transform health through innovative 

teaching and research in dentistry, medicine, nursing, biomedical sciences, pharmacy and 

public health. 

Prior to joining the Health Science Center, Dr. Giroir served as Vice Chancellor for Strategic 

Initiatives for the Texas A&M University System and Principal Investigator for the Texas 

A&M Center for Innovation in Advanced Development and Manufacturing, a public-private 

partnership with the U.S. Department of Health and Human Services designed to enhance the 

nation’s emergency preparedness against emerging infectious diseases, including pandemic 

influenza, and chemical, biological, radiological and nuclear threats. 

Dr. Giroir received his undergraduate degree in Biology, magna cum laude, from Harvard 

University and his medical degree from the University of Texas Southwestern Medical Center, 

Alpha Omega Alpha. His post-doctoral training was conducted at the Howard Hughes Medical 

Institute in Dallas under the mentorship of Dr. Bruce Beutler. Dr. Giroir remained on the 

faculty at UT Southwestern from 1993-2004, achieving a rank of tenured Professor. He held 

two endowed chairs, and served as the Associate Dean for Clinical Affairs at UT Southwestern 

Medical Center, as well as the first Chief Medical Officer at Children’s Medical Center of 
77 

Dallas. He has published extensively in both the basic and clinical literature, with special 

emphasis on host-pathogen interactions and novel therapies for life-threatening infectious 

diseases. 

As a member of the Defense Research Council from 1999-2004, he served as Co-Chair for 

several studies including Advanced Biological Weapons Decontamination, Joint Studies on 

Biological and Chemical Weapons Proliferation, Universal Medical Countermeasures to 

Biological Threat Agents, and Agricultural Biotechnology and Bioterrorism. From 2004 until 

2008, Dr. Giroir accepted the opportunity to serve in the Federal Government as Deputy 

Director, then Director, of the Defense Sciences Office of the Defense Advanced Research 

Projects Agency (DARPA) in Arlington, Virginia. Dr. Giroir directed a research portfolio of 

approximately $450 million annually that spanned from fundamental physics to biodefense. 

Dr. Giroir was appointed by USD-ATL to serve on the Threat Reduction Advisory Committee 

(TRAC) from 2008 – 2010, during which time he chaired the Chemical and Biological Defense 

Panel. 

Dr. Giroir is currently a member of the Scientific and Prevention Advisory Council of the 

Cancer Prevention and Research Institute of Texas (CPRIT), the Scientific Advisory Boards of 

the Biodesign Institute at Arizona State University and the A. Alfred Taubman Medical 

Research Institute at the University of Michigan, and on the Board of Directors for BioHouston 

and NASA’s National Space Biomedical Research Institute. Dr. Giroir is a former member of 

the American Board of Pediatrics, the Defense Sciences Research Council, The NASA 

Planetary Protection Panel, and an alumnus of the Defense Sciences Study Group. 

Dr. Giroir is the recipient of the Secretary of Defense Medal for Outstanding Public Service, 

the Texas A&M University System Excellence in Innovation Award in 2010, and was a finalist 

for the 2012 Dallas Morning News Texan of the Year Award. He is a native of Marrero, 

Louisiana, is married to Jill S. Giroir, J.D., and has two daughters, Jacqueline (Texas A&M 

’11) and Madeline (Texas A&M ’15).

Æ