[Senate Hearing 112-535]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 112-535




                               before the

                              COMMITTEE ON
                          UNITED STATES SENATE

                      ONE HUNDRED TWELFTH CONGRESS

                             SECOND SESSION


                             APRIL 26, 2012


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               JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan                 SUSAN M. COLLINS, Maine
DANIEL K. AKAKA, Hawaii              TOM COBURN, Oklahoma
THOMAS R. CARPER, Delaware           SCOTT P. BROWN, Massachusetts
MARK L. PRYOR, Arkansas              JOHN McCAIN, Arizona
MARY L. LANDRIEU, Louisiana          RON JOHNSON, Wisconsin
CLAIRE McCASKILL, Missouri           ROB PORTMAN, Ohio
JON TESTER, Montana                  RAND PAUL, Kentucky
MARK BEGICH, Alaska                  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

                            C O N T E N T S

Opening statements:
    Senator Lieberman............................................     1
    Senator Collins..............................................     3
Prepared statements:
    Senator Lieberman............................................    29
    Senator Collins..............................................    32

                        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


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

                           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.


    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 
    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 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 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.


    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.
    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 
    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 
    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 intended 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.


    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.
    \1\ The prepared statement of Dr. Fauci with attachments appear in 
the Appendix on page 34.
    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, influenza 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 
    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.
    \1\ The poster referenced by Dr. Fauci appears in the Appendix on 
page 48.
    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.
    \2\ The poster referenced by Dr. Fauci appears in the Appendix on 
page 50.
    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 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 
    \1\ The poster referenced by Dr. Fauci appears in the Appendix on 
page 51.
    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 

                       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.
    \2\ The prepared statement of Mr. Gerstein appears in the Appendix 
on page 53.
    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 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 potential 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 
    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 
    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 
    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 papers 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 
    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 
    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.
    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 dual-use 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 
    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.


    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.
    \1\ The prepared statement of Mr. Keim appears in the Appendix on 
page 59.
    It has been recognized for many years that science and 
technology can be used for both good purposes and bad. It is 
this two-sided 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 
    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 
    These recommendations were based upon the Board's finding 
that if this avian influenza virus acquires the capacity for 
human-to-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 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.


    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.
    \1\ The prepared statement of Dr. Inglesby appears in the Appendix 
on page 63.
    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 
    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 
excellent. 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 
    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 infected 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. 
    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.
    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.
    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.
    \1\ The letter referenced by Senator Lieberman appears in the 
Appendix on page 76.
    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 
    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 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 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 
    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 
point-by-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 
    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 
    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 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 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 
    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 
    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.
    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 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 
    Chairman Lieberman. Yes, Doctor.
    Dr. Inglesby. Can I just add to the good news side of the 
    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. 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 
    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.
    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 
budget-constrained 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 
    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 
    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 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 going through, particularly with 
the new policy and trying to get it right and implemented 
    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 
    [Whereupon, at 11:36 a.m., the Committee was adjourned.]

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