what systems are in place to monitor dual-use research that could produce dangerous results. what new systems are being put in place now. are more needed? and how do we balance these against our obvious valuation of the -- and valuing of the quest for knowledge, of free scientific inquiry. etched into the national academy of science's headquarters wall are the words of einstein, one of many words quoted often of einstein, the right to search for truth implies also a duty. one must not conceal any part of what one has recognized to be true, end of quote. but, of course, this matter before us this morning raises

another question that's relevant, which is what if peel away nature's veil and 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 this 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 in the question and answer period. and i thank you for being here. 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 select agent list. the testimony by the chairman of 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 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 the 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 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 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 bioweapon. that's 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 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's intended to improve our awareness of current and proposed dual-use research of concern and provide some guidelines for mitigating the associated risk. 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 mark-up in the appropriations committee that begins at 10:30. but i will certainly review the transcript of this hearing. thank you, mr. chairman. >> thank you, senator collins, for that thoughtful statement. and i'm sure whether it's at this particular meeting, appropriations or others you'll be watching out for the budgets of nih, dhs and others that may be recipients on the panel. >> absolutely. >> thank you. >> that's your record, i know.

our first two witnesses, dr. anthony fauci, really a national hero, at least a hero of mine. and i'm 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. >> thank you very much, mr. chairman. 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 re-emerging infectious diseases and the relationship of this type of research to biological security. as you mentioned in your statement, the issue at hand is the ongoing threat of the emergence of an h5n1 pandemic influenza and the research that was supported by the nih to address this threat. the conduct and publication of the results of such research in the form of the two manu scripts

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 aspects. 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 500,000 deaths globally. yet influenza has animal reservoirs especially in birds and these viruses can undergoing 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 pandemic. since these viruses continue to circulate in the world and are constantly evolving towards pandemic capability as we have seen in 1957, '68 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. nearly 60% of those reported cases have resulted in death. should the virus mutate to transmit more efficiently to and among people, a widespread influenza pandemic could ensue.

indeed, nature itself is the most dangerous bioterrorist, and even as we meet today, h5n1 and other influenza viruses of 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 determine what it is trying to do on its own in the wild and to prepare for it. such goals were pursued by the nih-funded scientists and could have important positive implications for pandemic influenza prediction, prevention, diagnosis and treatment. kawaoka and fouchier constructed in order to identify what genetic mutations might alter

the transmissibility of the virus. in their studies they deployed a standard influenza animal model, namely the ferret. this slide shows the basic design of the experiments in which the virus was modified to allow for aerosol transmission from one ferret to another. i might point out that one of the causes of the public misunderstanding was the widespread belief that the virus that was transmitted by aerosol from one ferret to another actually killed the ferrets. when, in, fact, that was not the case. we feel that these studies provide critical information and it was important to determine if h5n1 virus that has this enhanced transmissibility would remain sensitive to existing anti-influenza drugs and vaccines. in addition, and importantly, knowledge of the genetic mutations that facilitate transmission may be critical for global surveillance of emerging influenza viruses.

yet, since transmissibility of a virulence virus was increased, it is shown on this poster. if it is identified as durc that does not mean such research should not be published nor that it should be prohibited in the first place. however, it does call for us as you mentioned, to balance carefully the benefit of the research to the public health, the biosafety and biosecurity conditions under which the research is conducted and the potential risk that the knowledge gained from such research might fall into the hands of those with ill intent. in this regard, the national science advisory board for biosecurity or nsabb was asked to advise the united states

government on the publication of these manu scripts. you will hear in detail from dr. 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 governmentwide policy to address the issue. this policy which was released on march 29th, 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 benefiting 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 benefitting the public with the fruits of such research while ameliorating the existing risks. thank you. >> 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 undersecretary 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. we welcome your testimony now. >> thank you. good morning, chairman lieberman, ranking member collins. i thank you for the opportunity to testify today regarding dual-use life science research of concern. my testimony today will describe both department of homeland security mechanisms for addressing and mitigating dual-use concerns arising from internal life sciences research that dhs funds or performs as well as dhs involvement in u.s. government and 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 hh5n1 papers have clearly demonstrated. dhs performs research which might be considered durc through a variety of mechanisms, including internal laboratories such these national biodefense analysis and countermeasures center and plum island animal disease center. 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 recumbent foot and mouth disease vaccine. the 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 united states 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' primary objective in funding activity in the life sciences to meet our homeland security mission. we exercise control of the information through nonpublication or nondisclosure mechanisms. research conducted or funded by

dhs in the areas of biological and chemical defense under goes particularly 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 multidimensional. 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, nsabb definition of durc embodied in the nsabb 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 office or capo reviews projects that are to be conducted. this review divides potential projects into tiers based on whether they include nsabb experiments of concern, raised 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 or crg, chaired by our deputy secretary with full participation across the staff reviews all durc with a particular eye towards ensuring compliance with chemical weapons convention and biological weapons convention, bwc. dhs contracts for life science research that involves use of select agents and toxins or that requires 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've 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 29 march government policy for durc oversight. we're 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. governmentwide policy on oversight of u.s.-funded life

sciences research, dhs believes that security related concerns to durc cannot be entirely resigned 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 human kind. but will also require careful stewardship, including development of appropriate regulations and policies, as well as continued emphasis on strong biorisk management programs that emphasize biosafety, biosecurity and bioethics. in working through this issue, we must find ways to mitigate risks associated with the potential malicious use of durc

while allowing for open and unfettered investigation by our 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 human kind for public health, medical or biotechnology advancement versus the potential for misuse. ultimately, the international life sciences community must appreciate the durc problem and internal eyes these concerns while developing and conducting research. in this regard, the h5n1 papers have served 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. >> thanks, dr. gerstein. just while we have you, and while it's on my mind. 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. >> well, senator, we sit as part of the inner agency body that deliberates. and so we have a strong voice. in fact, as i'm sure we'll talk more about later, the 29 march 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 seven experiments of concern. we've always looked at the select agent program to make sure that we are in accordance with the requirements and reporting requirements. so we do that tiered process in order to make sure that experiments do full and fall -- full compliance with the bwc. what we've done, though, because of the alignment of the 29 march policy and the work that we have done previously, we essentially have a leg up on the implementation of the 29 march policy. >> okay. and just to take this one step further. on the board on which you sit, is this to determine governmentwide policy or also to approve particular projects or to evaluate particular research projects? >> these are internal boards that are designed to look at the department's experimentation.

the projects that we're to be conducting. >> okay. and then finally, just give us a sense, and i don't 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. the natural place to think about it is nih. but i presume dod is also doing funding projects, et cetera? >> well, senator, i'd like to stick to my department and just tell you what we're doing in the department of homeland security. we, 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 don't rise to the level of concern. in the tier two, ones that could perhaps have some issues with perception. we do 12 to 15. and then in the highest category, we do five to ten. so a total of about 225 experiments per year of which all of them run through our compliance review group process. >> and those are all funded within dhs? >> they are, yes. >> so maybe dr. fauci, you are the one to turn to give us for the record a broader sense of how widely dual-use research is either being done or in federal agencies or funded by federal agencies. >> okay. so that's a very good question, mr. chairman. and it's important, as you did yourself, distinguish between dual-use research and dual-use research of concern. any time you go near a microbe, it's dual-use research. if your talking about dual-use research of concern, we, just for this purpose, as part of the implementation of the march 29th governmentwide policy, we did an inventory of what we do with our own scientists at the nih and at the nih-funded government

scientists, as well as the external extramural grantees and contractors. when we did an inventory of what we do mostly on a bethesda campus and in the rocky mountain campus, there were 404 intramural projects that could be dual use, plus 147 manu scripts and none were found to be dual-use research of concern. when we did the extramural experiment 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. out of 381, there were only 10. and those are the ones we're now going through the process that's delineated carefully in the new policy. that's the scope of what we're

doing at nih. >> okay. that's very helpful. just generally, am i right to assume that there's -- there may be dual-use research projects of concern for instance at the -- funded by the department of defense? >> as dr. gerstein, i'd hesitate to make a statement about the department of defense. we collaborate a lot with them and, yes, i cannot imagine that they're not doing some. but probably a really small amount. but they clearly are doing some. >> okay. so most is probably coming through nih. okay. 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. >> chairman lieberman, thank you for holding this hearing on