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

                                                            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

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            COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

                   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:
                                                                       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

                        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 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.

                  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.
        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 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.

      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.
    ---------------------------------------------------------------------------
        \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
    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.
    ---------------------------------------------------------------------------
        \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
    intent.
    ---------------------------------------------------------------------------
        \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
    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.
    ---------------------------------------------------------------------------
        \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
    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 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
    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.
        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
    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.
    ---------------------------------------------------------------------------
        \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
    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
    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.

       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.
    ---------------------------------------------------------------------------
        \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
    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
    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
    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 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.
    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.
        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
    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 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
    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
    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
    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 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
    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.
        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
    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. 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.
        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
    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 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
    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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