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75–273 PDF 2012

S. Hrg. 112–535 

BIOLOGICAL SECURITY: THE RISK OF DUAL-USE 

RESEARCH 

HEARING 

BEFORE THE

COMMITTEE ON 

HOMELAND SECURITY AND 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE 

ONE HUNDRED TWELFTH CONGRESS 

SECOND SESSION 

APRIL 26, 2012 

Available via the World Wide Web: http://www.fdsys.gov/ 

Printed for the use of the 

Committee on Homeland Security and Governmental Affairs 

( 

(II) 

COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS 

JOSEPH I. LIEBERMAN, Connecticut, Chairman 

CARL LEVIN, Michigan 

DANIEL K. AKAKA, Hawaii 

THOMAS R. CARPER, Delaware 

MARK L. PRYOR, Arkansas 

MARY L. LANDRIEU, Louisiana 

CLAIRE MCCASKILL, Missouri 

JON TESTER, Montana 

MARK BEGICH, Alaska 

SUSAN M. COLLINS, Maine 

TOM COBURN, Oklahoma 

SCOTT P. BROWN, Massachusetts 

JOHN MCCAIN, Arizona 

RON JOHNSON, Wisconsin 

ROB PORTMAN, Ohio 

RAND PAUL, Kentucky 

JERRY MORAN, Kansas 

MICHAEL L. ALEXANDER, Staff Director 

CHRISTIAN J. BECKNER, Associate Staff Director for Homeland Security 

Prevention and Protection 

CARLY A. COVIEO, Professional Staff Member 

NICHOLAS A. ROSSI, Minority Staff Director 

BRENDAN P. SHIELDS, Minority Director of Homeland Security Policy 

JARED F. GOLDEN, Minority Professional Staff Member 

TRINA DRIESSNACK TYRER, Chief Clerk 

PATRICIA R. HOGAN, Publications Clerk 

LAURA W. KILBRIDE, Hearing Clerk 

(III) 

C O N T E N T S 

Opening statements: Page 

Senator Lieberman ........................................................................................... 1 

Senator Collins ................................................................................................. 3 

Prepared statements: 

Senator Lieberman ........................................................................................... 29 

Senator Collins ................................................................................................. 32 

WITNESSES 

THURSDAY, APRIL 21, 2012 

Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, U.S. Department of Health and 

Human Services ................................................................................................... 5 

Daniel M. Gerstein, Ph.D., Deputy Under Secretary for Science and Technology, U.S. Department of Homeland Security ................................................ 7 

Paul S. Keim, Ph.D., Acting Chairman, National Science Advisory Board 

for Biosecurity, National Institutes of Health, U.S. Department of Health 

and Human Services ............................................................................................ 11 

Thomas V. Inglesby, M.D., Chief Executive Officer and Director, Center for 

Biosecurity, University of Pittsburgh Medical Center ...................................... 14 

ALPHABETICAL LIST OF WITNESSES

Fauci, Anthony S., M.D.: 

Testimony .......................................................................................................... 5 

Prepared statement with attachments ........................................................... 34 

Gerstein, Daniel M., Ph.D.: 

Testimony .......................................................................................................... 7 

Prepared statement .......................................................................................... 53 

Inglesby, Thomas V., M.D.: 

Testimony .......................................................................................................... 14 

Prepared statement .......................................................................................... 63 

Keim, Paul S., Ph.D.: 

Testimony .......................................................................................................... 11 

Prepared statement .......................................................................................... 59 

APPENDIX 

Letter from Michael T. Osterholm, Ph.D., M.P.H., Director Center for Infectious Disease Research and Policy, University of Minnesota, to Amy P. 

Patterson, M.D., Associate Director for Science Policy, National Institutes 

of Health, dated April 12, 2012, submitted by Senator Lieberman ................. 76 

Response to post-hearing questions for the Record: 

Dr. Fauci ........................................................................................................... 83 

Dr. Gerstein ...................................................................................................... 88 

Dr. Keim ............................................................................................................ 96 

(1) 

BIOLOGICAL SECURITY: THE RISK OF 

DUAL-USE RESEARCH 

THURSDAY, APRIL 26, 2012 

U.S. SENATE, COMMITTEE ON HOMELAND SECURITY

AND GOVERNMENTAL AFFAIRS, Washington, DC. 

The Committee met, pursuant to notice, at 10:06 a.m., in room 

SD–342, Dirksen Senate Office Building, Hon. Joseph I. Lieberman, presiding. 

Present: Senators Lieberman and Collins. 

OPENING STATEMENT OF CHAIRMAN LIEBERMAN 

Chairman LIEBERMAN. The hearing will come to order. 

Good morning, and thanks very much to our really distinguished 

panel of witnesses. We use the word ‘‘distinguished’’ around here 

very easily, but it actually does relate to this panel and I thank you 

for being here. 

If I may begin by looking back a bit, in 1851, a revolution in 

medicine already underway was crystallized in a letter Louis Pasteur wrote to a friend, ‘‘I am on the edge,’’ he said, ‘‘of mysteries 

and the veil is getting thinner and thinner.’’ Thanks to the work 

of Pasteur and succeeding generations of scientists, the mysteries 

of the microbial world have slowly been revealed and we are all a 

lot healthier and living a lot longer as a result. Childhood diseases 

like polio and measles have, in many ways, been vanquished. Scientists were able to identify the acquired immunodeficiency syndrome (AIDS) virus, which helped lead to treatments. And according to one of our witnesses today, the real possibility of a cure for 

AIDS is in sight. 

The last global pandemic, the Spanish Flu pandemic, which 

killed on a massive scale, at least 50 million people, was almost a 

century ago. I remember this because it deprived me of ever knowing one of my grandmothers, my paternal grandmother who died 

as a young woman in New York in that pandemic. 

But in addition to all the medical miracles that were underneath 

that veil Pasteur began to peel back, there were, of course, also 

dangers. Research that could lead to cures, extending life for millions, also could kill many if a rogue pathogen were released either 

by accident or because it fell into what I will call evil hands. And 

it is this paradox of dual-use research that we gather together 

today to consider at this hearing. 

Last fall, the world was shaken by the news that two research 

teams, working independently had been able to engineer a new 

2 

strain of the H5N1 virus, which we know as Bird Flu, that could 

easily infect humans. Epidemiologists have long feared that if the 

H5N1 virus ever made the jump from a virus mostly confined to 

birds to one easily transmitted among humans, it could swiftly 

cause a pandemic. The mortality rate for the few reported cases in 

humans who have been infected is as high as 60 percent. By contrast, the Spanish Flu, which I mentioned earlier, had a mortality 

rate of about 2 percent. 

The researchers that I referred to, based both at Erasmus University in the Netherlands and at the University of Wisconsin, announced that they were going to publish the results of their studies 

in the journal, Science and Nature. This set off what I would call 

a global ethics debate in the scientific community about whether to 

publish or not publish these results, and if the experiments, which 

were funded by the National Institutes of Health (NIH), should 

have been undertaken at all. 

On the one hand, there are those who say that getting this information out could help other scientists better understand the mutant strain so they could prepare for a possible pandemic by looking for natural mutations and developing vaccines and medications. 

The fact that these two research teams were able to create this 

new strain from existing genetic material means that nature could 

create it, as well. In fact, many scientists said that that was quite 

likely. 

But given the lethality of the virus, others argued that publishing the results would create a huge security risk because it 

would offer a blueprint for a deadly biological weapon to rogue 

states or terrorists, and, of course, that is where this Committee’s 

interest is drawn because of our responsibility for homeland security. 

In a recent speech at a biological weapons conference in Geneva, 

Secretary of State Clinton warned that al-Qaeda in the Arabian Peninsula had, in fact, issued a call for ‘‘brothers with degrees in 

microbiology or chemistry to develop a weapon of mass destruction.’’ And, of course, there is also a danger that the manufactured 

strain might somehow escape, so to speak, from the laboratory, 

which is something we have worried about in the past. 

Last December, at the request of the Department of Health and 

Human Services (HHS), the National Science Advisory Board for 

Biosecurity (NSABB), was asked to review the H5N1 research papers. The NSABB concluded that more needed to be known before 

the research was made public and they asked the editors of Science 

and Nature to delay publication. 

Last month, after further review, the NSABB withdrew its objections and voted unanimously to allow the University of Wisconsin 

study to be published, and by a divided vote of 12–6 to allow the 

Netherlands study to be published with some revisions and clarifications. 

One of the things that apparently influenced the Board’s decision 

was the revelation that the modified strains of H5N1 had become 

less lethal. But as the members of the panel know, I am sure, that 

decision has drawn criticism from Dr. Michael T. Osterholm, Director of the Center for Infectious Disease Research and Policy at the 

University of Minnesota and an NSABB Board member himself. In 

3 

a letter to the NIH, he wrote that the NSABB had deliberately ignored the voice of scientists who believed publication of the H5N1 

research was dangerous, and I quote from his letter. ‘‘I believe 

there was a bias toward finding a solution that was a lot less about 

a robust science and policy-based risk-benefit analysis and more 

about how to get out of this difficult situation.’’ He then added, ‘‘We 

cannot just kick the can down the road without coming to grips 

with the very difficult task of managing,’’ and I know he was referring to dual-use research. So this is a serious charge, which I hope 

as the morning goes on the panel will respond to. 

The publish or not publish debate continued earlier this month 

during a 2-day conference of the world’s leading scientists convened 

by the Royal Society in London. One point I learned that most of 

the attendees seemed to agree on is that we need to put in place 

better systems to track this kind of research at each experimental 

stage rather than waiting until it is ready for publication to make 

decisions about what can be revealed. That is another question that 

I hope our panelists will discuss today. 

Although this particular controversy about publication appears to 

have been resolved, it is going to recur and, as Dr. Osterholm said, 

we cannot just kick the can down the road and deal with it on an 

ad hoc basis. What systems to monitor dual-use research that could 

produce dangerous results were in place at the time these experiments were begun? What new systems are being in place now? Are 

more needed? And how do we balance these against our obvious 

valuation of the valuing of the question for knowledge, of free scientific inquiry? 

Etched into the National Academy of Sciences headquarters wall 

are the words of Einstein, one of Einstein’s many phases that are 

quoted often, ‘‘The right to search for truth implies also a duty. 

One must not conceal any part of what one has recognized to be 

true.’’ But, of course, this matter before us this morning raises another question that is relevant, which is what if peeling away nature’s veil, in Pasteur’s term, unleashes dangers to the world? 

Those are difficult questions to balance, and again, I repeat that 

we ask them here in this Committee because of the direct connection between the scientific work and the homeland security of the 

American people, which it is our first responsibility to protect. I 

really look forward to your testimony and the question and answer 

period, and again, I thank you for being here. 

Senator Collins. 

OPENING STATEMENT OF SENATOR COLLINS 

Senator COLLINS. Thank you, Mr. Chairman. 

It has been almost a century since the 1918 Spanish influenza 

virus infected one-fifth of the world’s population, killing more than 

50 million people and claiming some 600,000 American lives. Yet 

virulent strains of influenza are still a major threat. 

The H1N1 strain, more commonly known as the Swine Flu, 

claimed more than 18,000 lives during the 2009 outbreak and exposed gaps in our preparedness capabilities for response to a global 

pandemic, especially in the development, production, and distribution of life-saving vaccines. 

4 

In 2008, this Committee held a hearing on the report by the 

Commission on the Prevention of Weapons of Mass Destruction, 

which examined the security of biological pathogens on the select 

agent list. The testimony by the Chairmen of the Commission, 

former Senators Bob Graham and Jim Talent, helped to raise 

awareness on the issue of biosecurity and the need to ensure that 

deadly pathogens and the research carried out on them are contained in secure lab facilities. 

This Committee has also held numerous hearings on the Nation’s 

efforts to prevent, prepare for, and mitigate the impact of a pandemic influenza outbreak. In 2009, the Administration’s failure to 

ensure that the government was prepared to rapidly distribute vaccines was and remains a cause for great concern. 

Preparedness also requires investing in critical life sciences research to expand our knowledge base and technologies to help us 

better respond to the next potential global pandemic. Such a pandemic could be even more communicable than the 1918 influenza 

virus or as virulent as the Avian Flu virus. The World Health Organization (WHO) has documented 576 human cases of Avian Flu 

infection worldwide since 2003, 339 of those cases resulted in 

death. 

Recently, research funded by the National Institutes of Health 

and conducted in Wisconsin and the Netherlands resulted in genetic changes to a strain of Avian Flu that allowed its airborne 

transmissibility. The NIH-funded researchers planned to publish 

their full findings in two academic journals. Now, publication, peer 

review, and replication of findings are obviously important steps in 

a vigorous scientific process. But others have expressed concern 

that the publication of the methodology and some of the data could 

help create a road map for terrorists and others seeking to further 

modify the virus into a bio-weapon. That is why a government advisory board, the National Science Advisory Board for Biosecurity, 

recommended in late December that partial information be withheld from publication. 

Late last month, however, the Board—with some dissenters—reversed course, and is now advocating for the full publication of the 

research done in Wisconsin as revised, and the publication of a revised paper on the research performed in the Netherlands. The decision and its reversal have been part of a larger debate within the 

scientific and national security communities and there are important arguments being made on both sides. When the American people pay for scientific research intended for the common good, they 

have a right to expect that their money will not be used to facilitate terrorism. 

These are not hypothetical threats. Before he was killed, Anwar 

al-Awlaki reportedly sought poisons to attack the United States. 

Adding to these concerns, the new leader of al-Qaeda has a medical 

background. Therefore, he may have an even greater interest in 

pursuing chemical and biological terrorism. 

At the same time, there is a legitimate concern about government censorship that could chill academic freedom and scientific 

inquiry or even limit the sharing of information necessary to save 

lives or improve public health. Recently, NIH released a new policy 

for the oversight of dual-use research of concern. This policy is inVerDate Nov 24 2008 12:35 Oct 03, 2012 Jkt 075273 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 P:\DOCS\75273.TXT SAFFAIRS PsN: PAT
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1The prepared statement of Dr. Fauci with attachments appear in the Appendix on page 34. 

tended to improve our awareness of current and proposed dual-use 

research of concern and provide some guidelines for mitigating the 

associated risks. This new policy, however, is only the beginning of 

what must be a straightforward dialogue among science, health, 

national security, and government experts and leaders in order to 

promote scientific research while protecting the safety of Americans 

and others around the world. 

I look forward this morning to hearing and reviewing the testimony of our witnesses about these challenging issues and how we 

can strike the right balance. 

I do want to apologize that I will, however, have to leave early 

due to a markup in the Appropriations Committee that begins at 

10:30, but I will certainly review the transcript of this hearing. 

Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thank you, Senator Collins, for that 

thoughtful statement. I am sure whether it is at this particular 

hearing, Appropriations, or others, you will be watching out for the 

budgets of NIH, the Department of Homeland Security (DHS), and 

others that may be recipients on the panel. 

Senator COLLINS. Absolutely. 

Chairman LIEBERMAN. That is your record, I know. 

Our first witness is Dr. Anthony Fauci—really a national hero, 

at least a hero of mine and I am sure others—Director of the National Institute of Allergy and Infectious Diseases at NIH. I really 

appreciate that you are here today and we look forward to your testimony now. 

TESTIMONY OF ANTHONY S. FAUCI, M.D.,1 DIRECTOR, 

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Dr. FAUCI. Thank you very much, Mr. Chairman and Senator 

Collins. Thank you for the opportunity to testify today on the NIH 

mission of performing biomedical research for the purpose of preparing for and responding to naturally emerging and reemerging 

infectious diseases and the relationship of this type of research to 

biological security. 

As you mentioned in your statement, the issue at hand is the ongoing threat of the emergence of an H5N1 pandemic influenza and 

the research that was supported by the NIH to address this threat. 

The publication of the results of such research in the form of the 

two manuscripts that you mentioned has focused considerable public attention on the issue of dual-use research, namely research 

that is directed at providing new information critical to the public 

health, but at the same time has the potential for malevolent applications. 

My written testimony is submitted for the record, and in my few 

minutes of time, I will highlight just a few important aspects of 

this issue. 

First, the public health challenge. Seasonal influenza is an ongoing threat to public health worldwide and is among the leading 

global causes of death due to infectious diseases. Each year, influVerDate Nov 24 2008 12:35 Oct 03, 2012 Jkt 075273 PO 00000 Frm 00009 Fmt 6633 Sfmt 6633 P:\DOCS\75273.TXT SAFFAIRS PsN: PAT
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1The poster referenced by Dr. Fauci appears in the Appendix on page 48. 

2The poster referenced by Dr. Fauci appears in the Appendix on page 50. 

enza causes more than 200,000 hospitalizations and up to 49,000 

deaths in the United States and up to a half-a-million deaths globally. Yet influenza has animal reservoirs, especially in birds, and 

these viruses can undergo extensive genetic changes and jump species, resulting in an influenza virus to which humans are highly 

vulnerable. 

Such an event can and historically has led to global disasters, 

such as the one you mentioned, the prime example being the 1918 

global influenza pandemic that killed up to 100 million people 

worldwide and caused enormous social and economic disruption. 

There is a clear and present danger that we will have another influenza pandemic, since these viruses continue to circulate in the 

world and are constantly evolving toward pandemic capability, as 

we have seen in 1957, 1968, and 2009. 

Over the last decade, a highly pathogenic H5N1 influenza has 

emerged among chickens. Rarely, the virus spreads to humans. 

Since 2003, approximately 600 confirmed cases have occurred in 

humans in more than a dozen countries shown in red on this poster.1 Nearly 60 percent of those reported cases have resulted in 

death. Should the virus mutate to transmit more efficiently to and 

among people, a widespread influenza pandemic could ensue. 

Indeed, nature itself is the most dangerous bioterrorist, and even 

as we meet today, H5N1 and other influenza viruses are naturally 

mutating and changing with the potential of a catastrophic pandemic. This is not a theoretical danger. It is a real danger. 

For decades, NIH has supported basic influenza research included on transmissibility, host adaptation, and virulence. The goal 

is to anticipate what the virus is continually trying to do on its own 

in the wild and to prepare for it. Such goals were pursued by the 

NIH-funded scientists Kawaoka and Fouchier and could have important positive implications for pandemic influenza prediction, 

prevention, diagnosis, and treatment. 

Kawaoka and Fouchier constructed variants of H5N1 avian influenza in order to identify which genetic mutations might alter the 

transmissibility of the virus. In their studies, they employed a 

standard influenza animal model, namely the ferret. This poster 

shows the basic design of the experiments,2 in which the virus was 

modified to allow for aerosol transmission from one ferret to another. 

I might point out that one of the causes of the public misunderstanding was the widespread belief that the virus that was transmitted by aerosol from one ferret to another actually killed the ferrets when, in fact, that was not the case. 

We feel that these studies provide critical information and it was 

important to determine if H5N1 virus that has this enhanced 

transmissibility would remain sensitive to existing anti-influenza 

drugs and vaccines. In addition, and importantly, knowledge of the 

genetic mutations that facilitate transmission may be critical for 

global surveillance of emerging influenza viruses. 

Yet since transmissibility of a virulent virus was increased, this 

constitutes dual-use research of concern (DURC), which is shown 

7 

1The poster referenced by Dr. Fauci appears in the Appendix on page 51. 

2The prepared statement of Mr. Gerstein appears in the Appendix on page 53. 

on this poster.1 If a particular research experiment is identified as 

DURC, that designation does not necessarily mean that such research should not be published, nor should it even be prohibited in 

the first place. However, it does call for us, as you mentioned, to 

balance carefully the benefit of the research to the public health, 

the biosafety and biosecurity conditions under which the research 

is conducted, and the potential risk that the knowledge gained 

from such research might fall into the hands of those with ill intent. 

In this regard, the National Science Advisory Board for Biosecurity was asked to advise the U.S. Government on the publication 

of these manuscripts. You will hear in detail from Dr. Paul Keim, 

the Chair of that group, about the Board’s deliberations. Importantly, the public attention and concern generated by this issue has 

triggered a voluntary moratorium or pause on this type of research 

on the part of the influenza research community as well as a fresh 

look at how the U.S. Government handles DURC, as manifested by 

a formalization of a government-wide policy to address the issue. 

This policy, which was released on March 29, strengthens and 

formalizes ongoing efforts in DURC oversight and is described in 

my written testimony. The ultimate goal of the NIH in its embrace 

of this new policy is to ensure that the conduct and communication 

of research in this area remain transparent and open at the same 

time as the risk-benefit ratio of such research clearly tips towards 

benefitting society. 

The public, which has a stake in the risks as well as in the benefits of such research, deserves a rational and transparent explanation of how these decisions are made. The upcoming dialogue related to this policy certainly will be informative and, hopefully, productive in its goal of benefiting the public with the fruits of such 

research while ameliorating the associated risks. Thank you. 

Chairman LIEBERMAN. Thanks very much, Dr. Fauci. That was 

an excellent introduction to the topic and I look forward to asking 

you some questions. 

Next, Dr. Daniel M. Gerstein, Deputy Under Secretary for 

Science and Technology at the U.S. Department of Homeland Security, obviously sharing with the Committee the concern about 

whether this research represents a real threat to our homeland security, and if so, what we should do about it. Thanks so much for 

being here, and we welcome your testimony now. 

TESTIMONY OF DANIEL M. GERSTEIN, PH.D.,2 DEPUTY UNDER 

SECRETARY FOR SCIENCE AND TECHNOLOGY, U.S. DEPARTMENT OF HOMELAND SECURITY 

Mr. GERSTEIN. Thank you. Good morning, Chairman Lieberman 

and Senator Collins. I thank you for the opportunity to testify 

today regarding dual-use life science research of concern. 

My testimony today will describe both Department of Homeland 

Security mechanisms for addressing and mitigating dual-use concerns arising from internal life sciences research that DHS funds 

or performs as well as DHS involvement in U.S. Government and 

8 

other efforts to address security concerns arising from the life 

sciences research. 

As the Department considers the DURC issue, several principles 

help guide our thinking. First, DURC is an extremely complex 

issue for the scientific research and development community, balancing our Nation’s need to excel in science and exploration of robust technologies with ensuring our Nation’s security by preventing 

the misuse of such technology. 

Second, almost all research conducted today in bioscience and 

biotechnology contains some degree of dual-use application. 

Third, dual-use concerns must be addressed at a variety of different levels, from research funded by governments, to research 

funded privately, to experimentation done by individual scientists. 

And finally, there are both domestic and international dimensions to the DURC issue, as the recent H5N1 papers have clearly 

demonstrated. 

DHS performs research which might be considered DURC 

through a variety of different mechanisms, including our internal 

laboratories, such as the National Biodefense Analysis and Countermeasures Center (NBACC), and Plum Island Animal Disease 

Center (PIADC). We also sponsor and collaborate with other departments. Additionally, we provide funding to colleges and universities, primarily through our DHS Centers of Excellence Program. 

One vignette that demonstrates the degree to which dual-use research is both ongoing and critical to the DHS mission is the development of a recombinant foot-and-mouth (FMD) disease vaccine. 

The recombinant vaccine components are being developed through 

our DHS Center of Excellence at Texas A&M. The material is then 

shipped to Plum Island, where it is used in challenge tests employing live FMD virus. At Plum Island, DHS and the U.S. Department 

of Agriculture are working shoulder to shoulder in this effort. Once 

approved for licensure, a commercial company will produce the vaccine. This cross-cutting project demonstrates the importance of collaborative efforts in dual-use research. 

DHS’s primary objective in funding activity in the life sciences is 

to meet our homeland security mission. We, therefore, exercise control of the information where necessary through non-publication or 

non-disclosure mechanisms. Research conducted or funded by DHS 

in the areas of biological and chemical defense undergo particular 

scrutiny and high-level departmental review because of the potential to raise concerns regarding security, nonproliferation, and treaty compliance. 

At DHS, our approach to dual-use research is multi-dimensional. 

At the lowest levels, project managers are trained to understand 

and assess their programs for possible dual-use implications. The 

National Science Advisory Board for Biosecurity, definition of 

DURC embodied in the NSABB’s seven experiments of concern 

serves as the basis for this understanding. These same criteria 

have been identified for use in the new Federal-wide DURC policy. 

The DHS Compliance Assurance Program Office (CAPO) reviews 

projects that are to be conducted. This review divides potential 

projects into tiers based on whether they include NSABB experiments of concern, raise perceptions of noncompliance with arms 

control agreements, utilize select agents or toxins, have the potenVerDate Nov 24 2008 12:35 Oct 03, 2012 Jkt 075273 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 P:\DOCS\75273.TXT SAFFAIRS PsN: PAT
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tial to generate or reveal national security vulnerabilities, or provide information on threat agent production or dissemination. 

At the highest levels of the Department, our Compliance Review 

Group (CRG), chaired by our Deputy Secretary with full participation across the staff, reviews all DURC with a particular eye toward ensuring compliance with the Chemical Weapons Convention 

and Biological Weapons Convention (BWC). 

DHS routinely contracts for life science research that involves 

use of select agents and toxins or that require special biosafety provisions. In all cases, we ensure that contracts contain clauses to ensure conformity with applicable laws, regulations, and internal 

policies. In addition, research contracts for life sciences work typically provide for DHS to object to publication or disclosure. Further, depending on the type of proposed publication or disclosure, 

the information to be released must go through an internal review 

process. In the unlikely event that sensitive or classified material 

is produced from research projects funded through grants to academia, DHS requires grant recipients to create information protection plans which detail how the information would be identified 

and secured. 

Now, I have been discussing the internal management of DURC 

within DHS. Let me now turn briefly to the broader DURC issue. 

DHS has been an extremely active participant in the formulation 

of the U.S. Government policy on the dual-use research, including 

the March 29 government policy for DURC oversight. We are in 

complete agreement that strengthening DURC oversight and establishing regular reviews of U.S. Government funded or conducted research is both necessary and a responsible approach. 

However, even with the kind of internal DHS oversight policies 

described previously and the U.S. Government-wide policy on oversight of U.S. funded life sciences research, DHS believes that security-related concerns to DURC cannot be entirely resolved by formal U.S. Government policies. The international nature of life 

sciences research, coupled with the explosion in biotechnology funded by private sources, means that much of the DURC being conducted is not under direct U.S. Government control. Advances in 

the life sciences will undoubtedly create technological capabilities 

that will be of tremendous benefit to humankind but will also require careful stewardship, including development of appropriate 

regulations and policies, as well as continued emphasis on strong 

bio-risk management programs that emphasize biosafety, biosecurity, and bioethics. 

In working through this issue, we must find ways to mitigate 

risk associated with the potential malicious use of DURC while at 

the same time allowing for open and unfettered innovation by our 

Nation’s scientists and laboratories. At the end of the day, the 

DURC issue comes down to a risk-benefit evaluation of whether the 

balance is in favor of sharing the information for the good of humankind for public health, medical, or biotechnology advancement 

versus the potential for misuse. 

Ultimately, the international life sciences community must appreciate the DURC problem and internalize these concerns while 

developing and conducting research. In this regard, the H5N1 paVerDate Nov 24 2008 12:35 Oct 03, 2012 Jkt 075273 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 P:\DOCS\75273.TXT SAFFAIRS PsN: PAT
10 

pers have served as a necessary wake-up call for the life sciences 

community. 

Thank you for giving us the opportunity to testify today and we 

look forward to your questions. 

Chairman LIEBERMAN. Thanks, Dr. Gerstein. 

Just clarify for the record, and for me, what the role of the Department of Homeland Security is with regard to dual-use research 

happening outside of DHS grantees. 

Mr. GERSTEIN. Well, Senator, we sit as part of the interagency 

body that deliberates, and so we have a strong voice. And in fact, 

as I am sure we will talk more about later, the March 29 policy 

actually reflects much of the work that we have been doing previously in fulfilling our Biological Weapons Convention requirements. We made use of the NSABB’s seven experiments of concern. 

We have always looked at the select agent program to make sure 

that we are in accordance with the requirements and the reporting 

requirements. So we do that tiered process in order to make sure 

that experiments do fall in full compliance with the BWC. 

What we have done, though, is because of the alignment of the 

March 29 policy and the work that we have done previously, we essentially have a leg up on the implementation of the March 29 policy. 

Chairman LIEBERMAN. And just to take this one step further, the 

board on which you sit, is this to determine government-wide policy 

or also to approve and evaluate particular research projects? 

Mr. GERSTEIN. These are internal boards that are designed to 

look at the Department’s experimentation, the projects that we are 

to be conducting. 

Chairman LIEBERMAN. And then, finally, just give us a sense, 

and I do not think you have to get into too much detail here, about 

how widely dual-use research projects are being carried out or 

funded in the Federal Government. In other words, the natural 

place to think about it is NIH, but I presume DOD is also funding 

projects, etc. 

Mr. GERSTEIN. Well, Senator, I would like to stick to my Department and just tell you what we are doing in the Department of 

Homeland Security. Through our review process, our Compliance 

Review Group looks at a total of about 200 projects that fall into 

what we call Tier One, just regular experiments that do not rise 

to the level of concern. In the Tier Two, ones that could perhaps 

have some issues with perception—— 

Chairman LIEBERMAN. Right. 

Mr. GERSTEIN [continuing]. We do 12 to 15 experiments. And 

then in the highest category, we do 5 to 10 experiments. So a total 

of about 225 experiments per year, of which all run through our 

Compliance Review Group process. 

Chairman LIEBERMAN. And those are all funded within DHS? 

Mr. GERSTEIN. They are, yes. 

Chairman LIEBERMAN. So maybe, Dr. Fauci, you are the one to 

turn to to give us for the record a kind of broader sense of how 

widely dual-use research is either being done in Federal agencies 

or funded by Federal agencies. 

11 

1The prepared statement of Mr. Keim appears in the Appendix on page 59. 

Dr. FAUCI. So that is a very good question, Mr. Chairman, and 

it is important, as you did yourself, to distinguish between dual-use 

research and dual-use research of concern. 

Chairman LIEBERMAN. Right. 

Dr. FAUCI. Almost any time you even go near a microbe, it is 

dual-use research. If you are talking about dual-use research of 

concern, just for this purpose, as part of the implementation of the 

March 29 government-wide policy, we did an inventory of what we 

do both with our own scientists at the National Institute of Allergy 

and Infectious Diseases (NIAID) as well as the external extramural 

grantees and contractors. 

And just to give you some examples, when we did an inventory 

of what we do mostly on our Bethesda campus and in our Rocky 

Mountain campus, there were 404 intramural projects that could 

be dual-use plus 147 manuscripts and none were found to be dualuse research of concern. When we did the extramural inventory of 

all of the grantees—there were 381 grantees or contractors—10 of 

those grants were designated as DURC. Seven of them were in influenza, one in anthrax, one in plague, and one in botulism. So out 

of 381, there were only 10, and those are the ones we are now 

going through the process that is delineated very carefully in the 

new policy. So that is the scope of what we are doing at NIAID. 

Chairman LIEBERMAN. That is very helpful. And just generally, 

am I right to assume there may be dual-use research projects of 

concern, for instance, funded by the Department of Defense? 

Dr. FAUCI. I would hesitate to make a statement about the Department of Defense, but we collaborate a lot with them—— 

Chairman LIEBERMAN. Yes. 

Dr. FAUCI [continuing]. And yes, I cannot imagine that they are 

not doing some. 

Chairman LIEBERMAN. Good enough. 

Dr. FAUCI. But probably a really small amount. But they clearly 

are doing some. 

Chairman LIEBERMAN. So most is probably coming through NIH? 

Dr. FAUCI. Right. 

Chairman LIEBERMAN. Thanks very much. 

Next, Dr. Paul Keim, Acting Chairman of the aforementioned 

National Science Advisory Board for Biosecurity. We thank you 

very much, Dr. Keim, for being here, and please proceed with your 

testimony now. 

TESTIMONY OF PAUL S. KEIM, PH.D.,1 ACTING CHAIRMAN, 

NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY, 

NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

Mr. KEIM. Chairman Lieberman, thank you for holding this hearing on ‘‘Biological Security: The Risk of Dual-Use Research.’’ I am 

Paul Keim, the Acting Chair of the National Science Advisory 

Board for Biosecurity. I appreciate the opportunity to speak to you 

about dual-use research and in particular about the Board’s activities and our recent evaluation of two scientific papers concerning 

the H5N1 influenza virus. 

12 

It has been recognized for many years that science and technology can be used for both good purposes and bad. It is this twosided coin that we refer to as dual-use research. The problem is 

that all biological research can be construed as having potential 

bad applications as well as their good ones. 

The NSABB created a new term, dual-use research of concern to 

distinguish normal research from that with exceptionally high potential to be misused. The parameters defining DURC would include the magnitude of any danger and the immediacy of any 

threat as balanced against the overall benefits of the work. 

Over the last 8 years, the Board has advised the U.S. Government on best practices and policy approaches for research communication, personnel reliability standards, codes of conduct, and 

international engagement for issues associated with DURC. The 

Board has recognized that good policy needs to protect us from scientific misuse and protect the scientific enterprise from being overburdened with unnecessary regulation. Both are essential for our 

country to be safe, productive, and remain a global leader. 

The National Science Advisory Board for Biosecurity is comprised of well respected scientists, lawyers, infectious disease experts, scientific editors, and public health experts. We have an 8- 

year track record of protecting academic freedom while seeking policy recommendations that will minimize the misuse of biological 

sciences research. 

With that in mind, recognize the significance for the Board to 

unanimously recommend against the publication of two scientific 

papers in November 2011 due to their potential to be misused. The 

U.S. Government asked the Board to review two NIH-funded studies reporting mutations that allowed a highly dangerous bird flu 

virus to transmit from one ferret to another. By a split vote, the 

Board instead recommended to the government that key elements 

of the studies not be published and that only redacted papers were 

acceptable for general distribution. 

These recommendations were based upon the Board’s finding 

that if this avian influenza virus acquires the capacity for humanto-human spread and retained its current virulence, the world 

could face a pandemic of significant proportions. We found that the 

potential risk for public harm to be of unusually high magnitude. 

The Board has published its recommendations to the U.S. Government along with its rationale. Importantly, we pointed out that 

an international discussion was needed amongst multiple societal 

components to develop policy in this arena of high-consequence 

DURC. I would further note that in the few months since our recommendations were released, there has been a flurry of U.S. and 

international meetings to discuss the risks and benefits of these experiments. 

The research issues and policy consequences are now commonly 

known and being debated. This continuing global conversation is 

important for the scientific endeavor and for our biosecurity. 

In late March 2012, the U.S. Government tasked NSABB with 

reviewing revised versions of the two original manuscripts. This 

was coupled with a face-to-face meeting such that the Board could 

hear directly from the investigators about their research. In this 

meeting, the Board received non-public information about the risks 

13 

and benefits of the research from the international public health 

and research community as well as from the U.S. Government intelligence community. 

In a classified briefing from national intelligence counsel and National Counterterrorism Center representatives, the Board heard 

an assessment of the risk for misuse and of the global political 

ramifications associated with these papers. The details of these 

briefings are classified, but I can tell you that many of the Board 

were left with the impression that the risk of misuse did not appreciably increase with full publication, and there is a high likelihood 

of undesirable political consequences to not publishing. 

In addition, the U.S. Government has recently issued new policy 

guidelines targeting high consequence DURC. This was based upon 

the NSABB’s own definition of DURC and seven categories of experiments that warrant special consideration and targeting particular high-consequence pathogens. 

It is in this context that the Board arrived at different recommendations for the revised manuscripts. One paper was unanimously recommended for full publication while the other was recommended by a split vote of 12–6. In balancing the risks against 

the benefits of the revised manuscripts in the context of additional 

information and new U.S. Government policy, the Board shifted its 

position. 

In my opinion, the split vote is highly significant and signals that 

the Board still believes that there is great potential for misuse of 

information generated by these types of experiments. The majority 

of the Board members voted for publication, but they were clearly 

still troubled by this research and its potential to be misused. It 

is fair to say that the Board believes that these types of experiments will arise again and that these issues are not fully settled. 

As one Board member noted, we have only kicked this can down 

the road and will be dealing with it again in the future. 

It is critical that we establish policy that intensely monitors high 

potential DURC research from cradle to grave in order to protect 

us from misuse, but also to free low-potential DURC research from 

onerous regulations. We must be careful that we do not destroy the 

scientific enterprise as we try to protect against misuse of some research. Thank you. 

Chairman LIEBERMAN. Thanks very much, Dr. Keim. 

Let me just ask you, while the phrase is in my mind, what did 

you mean when you said or referred to undesirable political consequences from not publishing? 

Mr. KEIM. This information was conveyed in a classified briefing 

and we cannot talk about it in detail, but there are many international collaborative projects here in public health to try to control, predict, and understand influenza pandemics. Some of those 

political agreements are very fragile, and I think that it is fair to 

say that not releasing this information was seen by the intelligence 

community as having a detrimental effect upon those fragile relationships. 

Chairman LIEBERMAN. Understood. Thank you. 

Our final witness is Dr. Thomas Inglesby, Chief Executive Officer 

and Director, Center for Biosecurity, University of Pittsburgh Medical Center. Welcome back. 

14 

1The prepared statement of Dr. Inglesby appears in the Appendix on page 63. 

TESTIMONY OF THOMAS V. INGLESBY, M.D.,1 CHIEF EXECUTIVE OFFICER AND DIRECTOR, CENTER FOR BIOSECURITY, 

UNIVERSITY OF PITTSBURGH MEDICAL CENTER 

Dr. INGLESBY. Mr. Chairman, thank you for the chance to speak 

to you today. My name is Tom Inglesby. I am the Director for the 

Center for Biosecurity of University of Pittsburgh Medical Center. 

I am an infectious disease physician by training, and over the last 

two decades, I have seen many patients with influenza die despite 

excellent medical care in American hospitals. 

For many years, my Center colleagues and I have been studying 

avian pandemic flu and the public health actions that need to be 

taken to protect us from those challenges, and like all of you, I am 

deeply concerned that H5N1 is a major global threat. 

I have been opposed to the publication of the revised Fouchier 

manuscript. The breakthrough in that work was making H5N1 

transmissible through the air between ferrets. Just as wild type 

H5N1 kills ferrets when instilled into their tracheas, this engineered virus also kills ferrets the same way. So there is no evidence that I have seen publicly presented that this engineered 

virus would have less virulence in humans than wild type H5N1 

infection would. 

Were this virus to cause a human infection, it could acquire new, 

unpredictable virulence properties. So if this work were replicated 

after publication and if it led to human infection following accident 

or misuse, we cannot rule out the chance that it would lead to high 

case fatality in a spreading epidemic difficult to stop with quarantine, vaccine, or antivirals. As you noted, there are others in the 

scientific and public health communities who share this concern. 

That said, I appreciate that a deliberative process has taken 

place in the last 6 months. The majority of NSABB members, the 

U.S. Government agencies, and the journal, Science and Nature, 

have decided that this work should be published. I am concerned 

about this, but I recognize this decision has been made. So now it 

is time to look ahead and anticipate the future of H5N1 mammalian transmissibility research, which scientists are now poised to 

pursue. Here are some brief thoughts on benefits and risks of further pursuing this line of research. 

Will further engineering H5N1 mammalian transmissible viruses 

help improve surveillance? In my view, in the short term, it is unlikely. Genetic mutation data is not widely collected in avian flu 

surveillance systems. Very few sequences are analyzed in real time. 

Even if we could identify experimental mutations in birds in real 

time, the prescribed response would still be the same: Culling of infected birds, all flocks, regardless of the mutations of the virus. 

Until we have a surveillance system in place that collects far more 

genetic sequence, does so in time frames that are meaningful, and 

have predictive value sufficient to lead to additional action in the 

field, this action seems unlikely to practically improve surveillance. 

Nor is this research necessary to making H5N1 vaccine for reasons 

I explain in my written testimony. 

What could go wrong with mammalian transmissible H5N1? 

Could an accident occur? Biosafety at modern labs is generally exVerDate Nov 24 2008 12:35 Oct 03, 2012 Jkt 075273 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 P:\DOCS\75273.TXT SAFFAIRS PsN: PAT
15 

cellent. Accidents are uncommon, and most pathogens have little 

capacity for societal spread. But the accidental escape of an engineered mammalian transmissible H5N1 could result in catastrophe. Although it is uncommon, accidents do happen. In 1977, 

H1N1 caused a mini-pandemic, probably from a lab escape. Nine 

years ago, during the severe acute respiratory syndrome (SARS) 

outbreak, there were at least three incidents in which researchers 

working in Biosafety Level 3 (BSL-3) or BSL-4 labs in Singapore, 

Taiwan, and China accidentally infected themselves with SARS. I 

am not meaning to single out laboratorians for criticism. Mistakes 

are made by all types of professionals, doctors, pilots, rocket scientists, all of us, because we are human. We have to factor the possibility of human error, surprise, and accidents into our calculations of the risk of this research. 

Can we assure this research will not be replicated and deliberately misused? No. We can hope no potential adversary will have 

the competence or the intention to pursue this, but we cannot accurately predict the chances this work will be replicated by a malevolent or disaffected scientist somewhere in the world, or a terrorist 

group or a Nation State. 

What happens if a mammalian transmissible H5N1 starts to 

spread? Seasonal flu infects 10 to 20 percent of the world every 

year, as much as a billion people or more. The case fatality rate 

of wild H5N1 in the WHO database is nearly 60 percent, as you 

indicated. So if a strain of H5N1 with that fatality rate were engineered to spread like seasonal flu, hundreds of millions of people’s 

lives would be at risk. Even a strain 100 times less lethal would 

place at risk millions of people’s lives. 

So what should be done about H5N1 mammalian transmissible 

research going forward? First, I would extend the moratorium that 

Dr. Fauci discussed. The reasons many experts agreed with the 

moratorium are still valid. Before proceeding, we should have more 

confidence this research will lead to practical benefits, and we 

should look for other ways to study transmissibility that do not require engineering mammalian transmissible strains. If this work is 

allowed to continue, we should limit it to the smallest number of 

labs. My understanding is that the United Kingdom and Canada 

have indicated their concern by deciding this work can only be performed in BSL-4 labs. We should have these discussions in an 

open, transparent way that includes the scientific and public health 

communities. 

Second, let us decide if there are red lines that should not be 

crossed. For example, should increased lethality be engineered into 

mammalian transmissible strains in order to understand virulence? 

Should other avian flu strains be engineered for mammalian transmissibility? Should transmissible H5N1 strains be engineered to 

make them resistant to vaccines or antivirals so we can understand 

the genetics of those problems? We should decide now if there are 

any uncrossable lines. 

And third, the United States should continue to strengthen its 

pandemic preparedness efforts. Priorities should include the capacity to manufacture flu vaccine on a large scale—a universal flu vaccine and new antivirals—and better surveillance and culling of inVerDate Nov 24 2008 12:35 Oct 03, 2012 Jkt 075273 PO 00000 Frm 00019 Fmt 6633 Sfmt 6633 P:\DOCS\75273.TXT SAFFAIRS PsN: PAT
16 

fected flocks. Preparing for pandemic and avian flu is critically important. 

Let me turn to the policy for DURC that was recently announced. 

This policy is a good step towards addressing the kinds of issues 

raised by the H5N1 controversy. The success of the policy will depend on how it is implemented. In my written testimony, I provide 

recommendations for success of the policy and I will highlight four 

of them here. 

First, implement effectively at the local level. Scientists, their institutions, and their institutional biosafety committees will be crucial to the success of this policy. This is new territory for them, so 

training and education will be key. They will also need new members, new resources, and a clear process for elevating concerns. 

Second, learn from experience. This process will need to evolve 

as we learn. I understand that the NIH review of the portfolio 

found that 10 experiments warranted further risk management. It 

would be a valuable learning tool for the science community to understand these 10 cases. What caused the concerns? How were 

risks mitigated? I think this could be done in an unidentified way 

to protect the scientists. 

It would also be useful to learn as much as we can from the 

H5N1 risk assessment and risk management process. How were 

risks assessed? How were conflicts of interest managed? How did 

the process ensure all relevant judgments were considered and 

data seen? Going forward, the success of the DURC policy will depend on these issues. 

Third, attend to the regulatory burden. This new policy will add 

another process to be navigated by a scientific community that is 

already heavily regulated. We have to make sure we do not impose 

such a regulatory burden that scientists cannot continue their important work. And so to this end, I would recommend asking the 

National Academies to examine the effects of existing policy and 

regulatory burdens on U.S. scientists. 

And last, reaffirm the role of NSABB. It deserves a lot of credit 

for its work. NSABB members have done substantial public service. 

They have prepared valuable dual-use guidelines and spent a great 

deal of energy, intellect, and time on this H5N1 debate. An independent and strong NSABB should have an important role in 

DURC policy implementation going forward, and I hope that the 

NSABB will rarely be in the position of getting invited into the 

process after manuscripts have been submitted. I think we all 

agree in this room that the risk assessment and management process should happen early in the research process. 

To conclude, scientists who research influenza and other infectious diseases are working to improve our understanding of biology 

and to better the world. The United States needs to continue supporting entrepreneurial and talented scientists with the best ideas. 

At the same time, we need to acknowledge there are rare situations 

where the consequences of an accident or misuse are so serious 

that special processes are needed to manage the risk to the public, 

and this new DURC policy is a good step in that direction. 

Chairman LIEBERMAN. Thanks, Dr. Inglesby. 

17 

When we hear about accidental escape of pathogens from laboratories, we get alarmed. Talk a little more about it. Does that normally happen? 

Dr. INGLESBY. No. 

Chairman LIEBERMAN. Because the example you have stated, the 

infection of workers or personnel in the labs—— 

Dr. INGLESBY. Yes. In all the cases that I mentioned and in other 

cases, that is typically the way that an infection would escape a 

lab. A laboratorian would get infected. Usually when laboratorians 

are infected, though, they do not spread it to anybody else. 

Chairman LIEBERMAN. Right. 

Dr. INGLESBY. So the risk really is primarily to the person working in the laboratory. It is rare for the laboratorian to pose a risk 

outside the lab. 

Chairman LIEBERMAN. Right. Dr. Fauci, I assume that all the 

regulations, both before and after March 29, were intent on limiting the possibility of exposure to personnel? 

Dr. FAUCI. Definitely, Mr. Chairman. In general, definitely. And 

specifically, in the two cases that we are discussing as prototypes 

here today, the two laboratories, one in Wisconsin and one at Erasmus University, were very highly qualified, inspected multiple 

times, and given a rating of ‘‘meet or exceed’’ the standards for the 

kinds of protection we are talking about. 

Chairman LIEBERMAN. Good. Dr. Keim, let me ask you first 

about the two laboratories that were the subject of this concern. To 

the extent that you can, why was the ultimate decision unanimous 

in the case of Wisconsin and then mixed in the case of Erasmus 

University? 

Mr. KEIM. The underlying science and approaches that each laboratory took for doing these experiments were different. While the 

two studies lumped together a lot in our discussions, they were distinct. We viewed Dr. Yoshihiro Kawaoka’s approaches as having a 

greater biological control of the risks. It is one of the aspects that 

we have instituted routinely in biosafety experiments in the United 

States, where these types of experiments are performed in a biological context that would be less dangerous. For example, if we do 

an experiment where we add a novel gene or biological property to 

an organism, we prefer to do it with a pathogen that has been disarmed, or attenuated, to lessen the risk. 

And so in distinguishing the two research groups and their scientific approaches, the biggest difference is that one worked on a 

biological platform, the H1N1 virus that was viewed as less risky, 

and not as virulent than the other one. In contrast, taking the wild 

type H5N1 avian influenza virus, the raw material from nature, 

and then directly changing the transmissibility on that genetic 

platform was viewed as a potentially very risky experiment. 

Chairman LIEBERMAN. And if I understand, that difference had 

more to do with the scientific decisions of each team as opposed to 

differing levels of safety standards that they were operating under 

in their respective institutions or countries. 

Mr. KEIM. Yes. As Dr. Fauci has already pointed out, both institutions were heavily regulated, heavily reviewed, and both exceeded the current requirements for biological safety that are required 

to perform these types of experiments. 

18 

1The letter referenced by Senator Lieberman appears in the Appendix on page 76. 

Chairman LIEBERMAN. Dr. Keim and Dr. Fauci, I want to give 

you an opportunity to respond to the dissent in the letter which 

was, I gather, originally a confidential letter and then was leaked, 

from Michael Osterholm in his criticism of the NSABB decisions.1

And to some extent, Dr. Inglesby expressed some concern about the 

decision. 

Dr. Keim, please begin. 

Mr. KEIM. So first off, we are a Board of almost 25 highly qualified individuals and we rarely agree 100 percent on anything. 

Chairman LIEBERMAN. It sounds like Congress. [Laughter.] 

Mr. KEIM. I know. 

Chairman LIEBERMAN. Although we may not be highly qualified. 

[Laughter.] 

Mr. KEIM. I must say that we actually embrace this dissent, we 

use it and we actually cherish the different members and their differing opinions. This is true for this particular example, as well. 

I believe that this letter that was meant for an internal constructive criticism process, and to help us to understand in a retrospective fashion what we had done and what we had just come through 

as a board. As such, I view it as a very constructive type of communication. It was unfortunate that it was leaked and it became part 

of the public dialogue. The public nature of the ensuing debate has 

made it harder to have a constructive and proactive type conversation. 

That aside, many of the things that he said are worth carefully 

examining. One point made in the letter is that there was a bias 

in the witness list. I think that is true. The primary briefers that 

were brought to the hearing, were, in fact, the investigators themselves. They are inherently biased with an easily identifiable conflict of interest. They wanted their work published in these prestigious journals. In addition, we brought in a third investigator 

who has been collaborating with two primary research groups. His 

report and work was on how you use the mutation information for 

surveillance purposes. Again, this was an individual who would 

like to see their work published and, it can be argued, that they 

would see the benefits far clearer than the risks. 

However, I do not think this is of great concern, Mr. Chairman. 

The Board is comprised of experienced scientists and what we routinely do in our profession is look at scientific data and critically 

examine other scientists’ work. And so the biases that were inherent in those types of witnesses, I think, were not a problem for us. 

In fact, I think, that we dealt with the briefers’ conflict of interest 

very well. We had ample opportunity to ask very tough questions 

of the investigators. Dr. Ron Fouchier, for example, was in front of 

us for over 2 hours with lots of intense questioning about his work. 

In the end, I think that those inherent biases were something the 

Board could and did deal with quite well. 

One part of Dr. Osterholm’s letter criticized the intelligence briefing. This was a classified briefing that was presented by the U.S. 

Government intelligence community. Most of the Board members 

came into the briefing as academic scientists and we pretty much 

had to take this assessment on faith. We could not examine the 

19 

data or assumptions and had to assume that the assessments of 

the risks and the political consequences were fact. This is an environment where the Board is perhaps a little bit naive and did not 

have the capability to look behind these assessments in a critical 

fashion. The briefing was held at the ‘‘secret’’ level before we were 

told that the supporting information was at a higher level of classification. The intelligence community briefers were quite confident, 

and suggested to us that the risks of publishing these papers were 

minimal while the political consequences of not publishing were 

great. I think that this briefing had a great effect upon individual 

Board members’ deliberations and our ultimate decisions. Dr. 

Osterholm’s criticism of the briefing is hard for me to evaluate. I 

think that summary-type classified briefings may be unavoidable. 

At some level, all advisory boards will be faced with accepting such 

an evaluation at face value. 

The March 29 and 30 Board meeting was never set up to be a 

point-counterpoint debate but rather a fact finding endeavor with 

heavily emphasis on the researchers themselves. So we did not 

have time in the 6 hours to hear from every witness in the world. 

But we did succeed in hearing the most important witnesses, even 

if they were inherently biased. 

Chairman LIEBERMAN. Interesting. So if you had it to do over 

again—— 

Mr. KEIM. Absolutely, I would do many things different, Mr. 

Chairman. For one, I would make sure that DURC review was 

being performed long before it ever came to the Board. We were 

brought these papers under a very tight timeline back in October, 

2011. 

Chairman LIEBERMAN. Right. 

Mr. KEIM. In retrospect, the amount of effort it took to review 

this science was too large for the time line we were on. 

The process and the number of hours we put into reviewing these 

two papers was massive. It is clear that the new government policy 

for identifying DURC early in the research cycle is going to be critical for moving much of this evaluation early on, before it is submitted for publication. 

Chairman LIEBERMAN. Yes, that is a very important point. I 

mean, I agree with you that the dissent, even to some extent the 

bias, is not of itself of concern, particularly in scientific debate and 

discussion. But, obviously, from a homeland security point of view, 

we are concerned about the impact. Am I right that you are essentially, to the best of your ability, providing assurances that information is not going to be released in the two studies, particularly 

in the Fouchier study, that would significantly increase the risk of 

deliberate or accidental release of H5N1? 

Mr. KEIM. The Board was pretty confident in the case of the 

Kawaoka paper and the vote was unanimous. In the case of the 

Fouchier paper, it was a split vote. The vote was 12–6 and there 

were strong feelings on both sides. 

In this type of an advisory Board process, each of us had to 

weigh the evidence and it was not black and white. There were 

great uncertainties in this research. A relatively small number of 

ferrets were actually used in these experiments making the data 

less than definitive in some cases. Our understanding the biological 

20 

properties of these viruses is not 100 percent certain. In the end, 

the 18 Board members had to weigh the evidence as best they 

could. 

And I will tell you, you will not find a better group of people to 

do this. This Board is extremely qualified and capable to do this 

assessment. We worked very hard at understanding the risks and 

benefits, but were not unanimous and came to a split vote on the 

Fouchier paper. 

Chairman LIEBERMAN. Dr. Fauci, do you want to respond to the 

Osterholm complaints, and to some extent, to Dr. Inglesby’s concerns? 

Dr. FAUCI. Sure. Well, with regard to the letter, as you probably 

know, because I am sure that your staff or you have a copy of the 

letter, there were several issues that were brought up in there. I 

have to say that I agree with many of the things that Dr. Keim 

said in the sense of this is a strong Board, a really good Board. We 

have worked with them for a long time and I do not think they are 

going to be significantly influenced by what they might perceive as 

a bias. So if they did, I believe, as Dr. Keim has done in the past, 

if you have an issue with something, you bring it up. 

The letter was sent to the Executive Secretary of the NSABB, 

who is at NIH, Dr. Amy Patterson. We have responded on a pointby-point basis to everything in that letter, so we would be more 

than happy to make that response available to you so that you 

could see the point-by-point discussion. 

Again, there were important issues about looking forward. There 

were several things in there that I must say, quite frankly, Mr. 

Chairman, that I actually disagree with, one of which was the concern about the security briefing. I have a great deal of trust in the 

Director of the National Intelligence to tell us what we need to 

know. So that is just one example. 

The idea, as you mentioned, about the picking of people who 

would be on the agenda, we did not get any indication from Dr. 

Osterholm of people that he wanted to see there that were not 

there. 

So rather than go tit for tat on that, I can just say that I think 

the general principles that were brought up by Dr. Keim, I totally 

agree with. I just have to say for the record that I disagree with 

many of the things in his letter. 

Chairman LIEBERMAN. No, I appreciate that directness and I 

thank you for it. 

Do you have a reaction to Dr. Inglesby’s suggestion that the moratorium should be extended, and if so, for how long? 

Dr. FAUCI. I totally agree with Dr. Inglesby about an extension 

of the moratorium. The real critical issue is for how long. 

Chairman LIEBERMAN. Right. 

Dr. FAUCI. This is a voluntary moratorium, and I think that is 

something that the public needs to understand. This is a voluntary 

moratorium on the part of the scientific community. 

Chairman LIEBERMAN. Right. 

Dr. FAUCI. I had discussions with the influenza scientists and encouraged them and actually, to their credit and to the discussion 

that Dr. Keim himself had in the NSABB, this was something that 

they agreed upon. Exactly when to call it off, we are very actively 

21 

involved in pushing forward the principles and the implementation 

of the March 29 government-wide DURC policy. That is going to 

have an important impact on when we can feel comfortable that we 

can then go on, as long as people understand both the principles 

and the implementation mechanisms of how you address DURC. 

Several of the labs that are involved understand that now. We need 

to make sure that is broadly understood. So I definitely agree with 

that. 

I just want to make one point—— 

Chairman LIEBERMAN. Go ahead. 

Dr. FAUCI [continuing]. Of minor disagreement, if you want to 

call it that, with what my esteemed colleague, Dr. Inglesby, says. 

If we only looked at the short-term benefit of research, we would 

not do a lot of research at the NIH because you very often have 

a situation where it is incremental and you build up into something 

that really becomes important. So although I understand the point 

that is being made, if you look at what immediate benefit those 

mutations are going to have right now, sure, you can say that there 

is not a lot of surveillance capabilities of high sequencing, etc. But 

the incremental accumulation of knowledge is one of the fundamental principles that the NIH research agenda is built upon. 

So I think there is a little bit of a disagreement on that. I do not 

think you need to have an absolute immediate benefit for research 

to be ultimately important to do and to publish. 

Chairman LIEBERMAN. Do you want to respond? 

Dr. INGLESBY. Yes. Well, actually, I completely agree with what 

you just said, so I do not think we disagree on that. I agree that 

fundamental research into understanding biological principles is 

critical and it is a critical part of the science mission. I think this 

is just one very specific and rare example where I think the bar 

for whether to proceed with this line of research should be beyond 

a deeper fundamental understanding of biology. 

In general, I completely agree that the test for basic science 

should not be whether it has practical benefits in the next year. 

But in this case, a lot of the proponents of the research have been 

arguing for urgent practical benefit, and in my view, I just have 

not seen a compelling case for that. 

Chairman LIEBERMAN. It is not worth it. 

This leads me to ask you, Dr. Fauci, and anybody else who wants 

to answer—and in some sense, it is a question at the margins— 

when considering future research that would be seen as DURC, can 

you imagine instances in which you would conclude that research 

should not be undertaken under any circumstances? 

Dr. FAUCI. I do. I think it would be scientific hubris for scientists 

to say we can do anything that we want to do, regardless, just for 

the curiosity of it, for understanding it. So I do think there are 

some experiments that would better not be done. I think that 

would be a very rare situation, Mr. Chairman, I mean, you can fantasize about ridiculous and dangerous experiments just for the sake 

of doing it. Those, we do not even bother with. But in the realm 

of trying to keep up with something that is a clear and present 

danger of happening in nature itself—that is the critical thing that 

we are dealing with here and that is the reason why we agree so 

22 

much on it, and yet all of us at the table know that this is a delicate issue. 

If you are doing something in an experimental fashion that you 

might be pushing the envelope of creating something that would 

give you some information but it is not really addressing any danger, then I think that is very ill advised to go there. But when you 

have a situation where nature itself is already doing some of the 

things that you are trying to stay ahead of, that is when you really 

have to seriously consider it. 

The short answer to your question, the principles of the new government-wide DURC policy that we put out on March 29 actually 

put that into the consideration. So when you look at the number 

of experiments that you can do—there are now seven classic experiments, that if they come up, you have to decide if you have a risk 

mitigation for that particular result or experiment. 

One of the risk mitigations very well may be to not do the experiment. So it really falls very nicely into the answer to your question. 

It is built into the new government-wide DURC policy, that is, in 

fact, an option. 

Chairman LIEBERMAN. So I presume that this is not an area 

where you can draw a very clear red line, right? In other words, 

what you have described are the standards adopted in the policy, 

and particularly with regard to risk mitigation, and that in a given 

case, the decisionmakers might decide that in the interest of risk 

mitigation, the research simply should not be conducted. 

Dr. FAUCI. It is essentially a continual evaluation of risk-benefit. 

Chairman LIEBERMAN. Right. 

Dr. FAUCI. And you take each individual case and you look at it, 

and it could turn out that, clearly, the risk and our ability to mitigate the risk might be such that it is just not worth doing. 

Chairman LIEBERMAN. Dr. Gerstein, from a homeland security 

point of view, talk to us a little about whether you think that there 

ought to be clearer red lines here or whether this is an area of scientific inquiry where it is simply impossible to state a red line unless you see it in a particular proposal for a research project of concern. 

Mr. GERSTEIN. Well, Senator, I agree exactly with what Dr. 

Fauci said. I think there are some experiments that should not be 

done. In fact, that is actually the intent of the Compliance Review 

Group—— 

Chairman LIEBERMAN. Right. 

Mr. GERSTEIN [continuing]. Looking at the NSABB seven experiments and looking at the type of pathogens we routinely work with 

in this sort of threat analysis and characterizations that we do. So 

we look at these very hard. We make sure that all of them are 

needed. We make sure that we are doing them in the safest possible ways, in the appropriate facilities. But at the end of the day, 

we recognize that DHS needs to look at some of these different capabilities and assess what sort of threats they pose. 

Still, we are doing them in the highest containment. For the Department, we do most of our internal work in our facilities, the 

Fort Detrick facility, NBACC, and then the Plum Island facility, 

PIADC. So we are very keen on that. 

23 

Chairman LIEBERMAN. We have talked so far about the U.S. Government response to this challenge of dual-use research of concern, 

but, obviously, scientific research is global, and in this case one 

team is in Wisconsin, and one team is in the Netherlands. So help 

the Committee understand for the record, what is the state of the 

discussion of standards internationally? Are there international scientific bodies that are moving to adopt standards such as the 

March 29 U.S. policy? Are there national standards being adopted 

in individual countries throughout the world? What is happening, 

because obviously we are talking here about a fear, in one sense, 

of a global pandemic. So if something wrong happens in a laboratory halfway around the world, it could still affect the lives of people here in the United States. 

Dr. FAUCI. Let me take a shot at that, Mr. Chairman. 

Chairman LIEBERMAN. Please. 

Dr. FAUCI. It is very interesting, because this gets into what we 

refer to as the culture of responsibility, a global culture of responsibility. Back in the 1970s when the revolution in DNA technology 

took place globally, but fundamentally here in the United States, 

scientists got together—it is strikingly similar to the challenges 

that we are facing now—and came up with what we ultimately 

have right now, the DNA Recombinant Advisory Committee (RAC). 

And although that only pertains when you talk specifically about 

government-funded research here in the United States, what has 

happened is that the fundamental principles, the codes of conduct, 

and the culture of responsibility that was engendered by the discussions back in the 1970s regarding recombinant DNA technology, 

without any capability of enforcing it globally, essentially permeated the global approach towards recombinant DNA technology. 

So although we did not have any enforcement capability, it became 

something that was widely shared throughout the world. 

Now, other countries, including the Netherlands right now, are 

addressing in a very serious manner how they are going to approach this because it was one of their scientists. But this is also 

going on in the United Kingdom, in France, and places like that. 

So what we hope and what we envision is that as a result of this, 

there will be a culture of responsibility that even though we do not 

have the carrot and the stick of funding and withdrawing funding, 

that these kinds of principles will actually be implemented 

throughout the world. We are all hoping for that, and I actually 

have confidence that it will. 

Chairman LIEBERMAN. Good. Dr. Gerstein, I know that Secretary 

Janet Napolitano and people in the Department now are developing ongoing relations with homeland security departments or 

comparable departments around the world. Is there discussion of 

this particular concern in those international meetings? 

Mr. GERSTEIN. Senator, there is. We have had a number of 

bilaterals, for example, in the Directorate of Science and Technology (S&T). We have 12 nations with whom we have bilateral 

discussions. 

Chairman LIEBERMAN. Right. 

Mr. GERSTEIN. And we have had these discussions. The nations 

feel very similar to us, but there is not all good news as far as this 

is concerned, and I would take you back to the Biological Weapons 

24 

Convention. Some interesting things come out when you look at 

that. 

There is a London-based Verification, Research, Training, and 

Information Center (VERTIC), and in one analysis they did a couple of years ago, they discovered that very few nations of the 87 

that they surveyed even had laws or definitions of what a select 

agent is, and they did not have laws against developing, stockpiling, or storing biological material. And the news does not get any 

better when you talk about export control measures. 

So it highlights the fact that we may be working very hard in 

this country and we may put in place the proper provisions, but it 

is important that we do the international outreach, especially into 

some of the countries that may not have the same sense of the life 

science issue and the DURC issue that we do. 

Chairman LIEBERMAN. Yes, Doctor. 

Dr. INGLESBY. Can I just add to the good news side of the story. 

Chairman LIEBERMAN. Yes. 

Dr. INGLESBY. First of all, I think the H5N1 debate, as painful 

as it has been in the last 6 months, has been somewhat useful 

internationally because people are all paying attention to this 

issue. So I think that one good consequence of this has been enlightenment or awakening in many places in the world which were 

not paying attention to this. 

The second point is at a science meeting 2 weeks ago when this 

question came up and there was concern that private foundations 

would not follow the lead of the U.S. Government in the new policy, 

a representative from one of the most important science foundations stood up and said, let me make very clear, if the U.S. Government is going to pursue this policy, we absolutely intend to follow 

it ourselves, and I imagine that others will. 

And the third point of good news was an article published in the 

journal Nature yesterday, one of the most important science journals in the world, said that the United States is taking an important leadership position on this DURC policy and that other nations should follow suit. 

So there are some indications that maybe this will move in a direction where other people are doing similar things. 

Chairman LIEBERMAN. Well, that is encouraging. 

Let me go to a different aspect of the DURC policy which interested me, which is that it requires departments and agencies to report to the White House National Security Staff in the next several 

months on their current DURC projects and on risk and mitigation 

measures. The National Security Council (NSC) staff is probably 

larger than most people think, but it is still relatively small for the 

range and responsibilities it is given, particularly those on the NSC 

staff that work on biosecurity and bioterrorism issues. And I wonder whether you have a sense of how the information is going to 

be used to support oversight of such research and whether any of 

you expect your agencies and/or the NSABB will be asked to support the oversight that the White House National Security Staff is 

charged with carrying out here. Maybe I will start with you, Dr. 

Gerstein. 

Mr. GERSTEIN. Well, Senator, that would be somewhat speculative. I would just like to take you back to the deliberations to date. 

25 

We have used those deliberations to better understand what has 

gone on with the papers. We have been briefed on the science. We 

have been briefed on the policies, the issues that have surfaced. 

And I think what has come out of the March 29 White House-led 

effort is a good first start. What we expect is that this will continue, that this is not an end point, so to speak, but it is the beginning of a process that we will continue to look and try to ensure 

that our policies with regard to DURC are as good as they can be 

to ensure national security, but also homeland security as well as 

ensuring scientific work goes on unfettered. So in that regard, we 

are very hopeful. 

It is a reporting requirement. All departments and agencies are 

submitting to that. And we have not come up with the next step, 

so to speak, in trying to finalize the policy. This has generated, 

though, incredible discussions across the interagency where departments are getting together and discussing how they are handling 

it. We received several phone calls to see how we were dealing with 

our university grants program and the language that we have inserted that provides us at least a stop-gap measure should it be 

necessary to ensure that publication of certain materials would not 

proceed. 

So this has actually been a very positive outcome, I think, across 

the government. 

Chairman LIEBERMAN. Good. Dr. Keim, do you anticipate that 

the NSABB may be asked to help the White House in these reviews? 

Mr. KEIM. We do whatever the Administration asks us to do and 

we do not do anything they do not. [Laughter.] 

Chairman LIEBERMAN. A good standard. Thank you for that. 

Dr. Fauci, do you want to comment on that at all? 

Dr. FAUCI. Well, I actually agree with what Dr. Gerstein said. If 

you look carefully at the DURC policy—the part about within 60 

days to give an inventory, within 90 days to determine how you are 

going to do risk mitigation—that was really the first cut at making 

sure we know what is going on right now. I think this is going to 

be an evolving process. Ultimately, we are going to try and make 

sure that when you get down to the local level of the institutional 

biosafety committees, a lot of the kinds of monitoring that will be 

done will be essentially automatic by well-trained people. 

Chairman LIEBERMAN. I agree. 

Let me ask this question. In your testimony, Dr. Fauci, you discussed NIH-funded efforts to develop a universal influenza vaccine, 

and Dr. Inglesby highlights the ongoing efforts to develop vaccines 

focused on H5N1. I wonder whether the findings of these kinds of 

studies will lead NIH and other organizations that fund vaccine research to increase the priority that you are placing on these kinds 

of research efforts? 

Dr. FAUCI. The answer is a resounding yes. There are a couple 

of ways of getting rid of this problem. One of them, I think, Dr. 

Inglesby mentioned in his testimony, certainly in some discussions 

we have had, is to just kill the chickens that have H5N1 and make 

sure that we just get rid of the reservoir. That is very difficult to 

do because you have countries that are not necessarily interested 

for economic and other reasons. 

26 

The other thing is to have available countermeasures that actually work really very well. The idea of getting a universal influenza 

vaccine is not only going to be very important for seasonal influenza, so we do not have to keep chasing each year getting the right 

combination and matching it with what is circulating out there, but 

also, it is a major countermeasure against the emergence of a pandemic. 

So we are putting a considerable amount of effort, and we have 

had some very encouraging scientific advances over the past year 

and a half to 2 years on understanding much better the type of immune response that you need to induce in an individual to cover 

virtually all strains. We are not there yet, but this is something 

that we see as the light at the end of the tunnel. It is always risky 

to predict when you are going to get a vaccine for whatever, but 

unlike it was a few years ago, we now see that we have the scientific mechanisms and wherewithal that we are on the road to developing a universal flu vaccine. 

Chairman LIEBERMAN. Well, that is tremendously encouraging, 

and, of course, that is exactly the kind of work even in a budgetconstrained atmosphere that I hope we will find adequate funds 

for. 

Do you want to comment at all on that, Dr. Inglesby? 

Dr. INGLESBY. I would say that it is extremely encouraging. It is 

exciting. If we had a universal flu vaccine, it would change the risk 

equation for everything we have talked about today in the realm 

of influenza. So I would just strongly support the efforts that are 

going on at NIH by the industry on that. 

Chairman LIEBERMAN. I have a final question, which is the kind 

of question, I must say for the benefit of staff, that my friend and 

colleague from Delaware, Senator Carper, would normally ask if he 

were here. Incidentally, I learned a lot from the testimony today 

and, overall, I am reassured by the government policies that have 

been put into effect. Even at the far end that we have set up a decisionmaking process that considers and values risk mitigation and 

says, in some cases, it may be that there will be a decision that 

research should not proceed because it is impossible to adequately 

mitigate the risks. 

So the question Senator Carper would ask, I believe, if he were 

here, is if you were a member of the Committee, is there anything 

more that we, with our primary concern about homeland security, 

ought to be either asking the government to do or doing ourselves, 

either by way of encouraging regulation or, in the extreme, some 

kind of legislation? Dr. Inglesby. 

Dr. INGLESBY. I do not see at this point any legislative or regulatory proposal that would substantially improve the situation. I do 

think it is very useful to have oversight like this on the development of the new policy because I think there are a lot of things 

along the way that are going to be challenging. I think, for example, understanding the criteria for risk assessment and how we 

manage those risks is going to be very important. I think the composition and responsibilities of the NSABB will be very important. 

So asking reasonable questions of the government about how this 

new DURC policy is working as it evolves is very important, and 

I think, in particular, paying attention to the very specific case of 

27 

H5N1 mammalian transmissibility research. While the decision has 

been made to move on to publication for this experiment—which I 

am concerned about—I think the next issue is going to come up relatively soon unless there is a change in course. I think that will 

come up again, so I think you just have to pay attention to that. 

Chairman LIEBERMAN. Thank you. Dr. Keim. 

Mr. KEIM. I would just reiterate what Mr. Davis just said, that 

how the new policy is implemented is going to be very key. One important role that the NSABB has played is that we are an independent body. We are non-government. 

Chairman LIEBERMAN. Right. 

Mr. KEIM. And I think it is very important that we have ‘‘external eyes’’ as a part of this new policy’s implementation. There are 

inherent conflicts of interest between the funding agencies and the 

investigators, and the investigators themselves. While the board 

has infectious disease researchers, we were outside the small influenza research community and we were independent of the funding 

agencies. We are able to look at this problem in a way that is 

unique, and I think that is an important part to what needs to happen in the future. 

Chairman LIEBERMAN. I agree. Dr. Gerstein. 

Mr. GERSTEIN. Thank you, Senator. Well, I will go back to the 

original remarks I made, that I think it is a very complex issue. 

It requires balancing outcomes. We do not want to do something 

precipitously that is going to have a deleterious effect on the 

science. On the other hand, we have a very important mission in 

Homeland Security that we must ensure is well served. 

We do have to avoid red lines because the minute you put out 

a red line, somebody is going to figure out a way to cross it. And 

so the best way to do it is through very thoughtful, very 

judgmental type bodies like the NSABB that has played an extraordinarily important role in getting us through these two papers 

and understanding what was going on with those papers. So it 

really does come down to a matter of judgment. 

On the direct question, do we need legislation right now or regulations, I would say the Executive Branch has a lot of work to do 

to work through the policies. As we talked about, the March 29 

government policy is a first step. We are making great headway. 

We are continuing those deliberations. We are learning from each 

other. We think in DHS we have a lot of good policies that we have 

implemented. We are sharing those to the maximum extent possible. 

So I would like to put down a marker that says that perhaps 

later, after we have had some more time working through the 

March 29 policy and adding more meat to the bones, that we come 

and consult with Congress on this very critical issue. 

Chairman LIEBERMAN. That makes sense. I hope you will do 

that. Dr. Fauci. 

Dr. FAUCI. Yes. Mr. Chairman, I do not see any immediate legislative issue that would be appropriate at this point. But I think 

when you asked, if I were on the Committee, what would I do, I 

think what you just did today was really a very important thing. 

That is really very beneficial to this difficult process that we are 

28 

going through, particularly with the new policy and trying to get 

it right and implemented right. 

And the fact that an important Committee like this Committee, 

with yourself as Chairman, is actually interested in the subject, is 

looking at us—we know that we will come back to you sometime, 

and maybe soon, to just give you follow-up about how we are progressing on the implementation of this policy. So you have already 

done something, I think, that is very important and valuable to us, 

because not only here in the United States, but globally, people are 

aware that the U.S. Senate and this Committee are interested in 

this problem, and that adds a degree of seriousness to it which we 

appreciate. 

Chairman LIEBERMAN. Well, I appreciate you saying that, and 

that clearly is our intention. So let us agree we will keep in touch. 

As you know, we want the benefits of scientific inquiry. We need 

them. We also need to mitigate risk, and I think the policy that we 

have now is clearly aimed at doing exactly that. So we will follow 

it to see how it is going. Maybe we will come back again and do 

one more hearing toward the end of the year. 

But I thank you very much for the work you did on your prepared testimony, which will be entered into the record of the hearing, and for the testimony this morning. We are going to leave the 

record of the hearing open for 15 days for any additional questions 

or statements. 

With that, I thank you very much and the hearing is adjourned. 

[Whereupon, at 11:36 a.m., the Committee was adjourned.] 

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