microbial world have been revealed and we're all healthier and living longer as a result. polio and measles have in many ways, been vanquished. scientists were able to identify the 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 that killed on a massive scale, the spanish flu pandemic killed 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 granmother 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 also dangers. research that can lead to cures extending life for millions, also can 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 researchers working -- 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 comfined to birds to one easily transmitted among humans it can swiftly cause a pandemic. the mortality rate for the few reported cases in humans who have been infected is as high as 60% by contrast, the spanish flu

which i mentioned earlier had a mortality rate of about 2%. the researchers that i refer to based both at arasmus university in the netherlands and 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 nih were undertaken at all. on the one hand, there are those who say getting this information out could help other scientists better understand the mutant strain so they could prepare for a possible pandemic by investigating -- 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. of course, that's where this committee's interest is joined 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, i quote, brothers with degrees in microbiology or chemistry to develop a weapon of mass destruction, end quote. and, of course, there's also a danger that the manufactured strain might somehow escape, so to speak, from the laboratory which was something we worried

about in the past. last december, at the request of the department of health and human services, the national science advisory board for biosecurity or 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. both magazines agreed. 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 vote -- 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 nasabb board member himself. in a letter to the nih he wrote the nisabb had 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 can't just kick the can down the road without coming to grips with the very difficult task of managing. i know he was referring to the research. end of quote. 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 two-day conference of the world's leading scientists convened by the royal society in london. one point i learned a lot of the attendees seemed to agree on is we need to put in place better research to track this at each experimental stage rather than waiting until it's ready for publication to make decisions about what can be revealed. and that's another question that i hope our panelists will discuss today. although this particular controversy about publication appears to have been resolved, it's going to recur. as osterholm said, we can't just kick the can down the road and deal with it on an ad hoc baseis. 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 sdrbs 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 chairman 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 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 communeicable 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 r 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 fintime, i wi

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 tue 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 influ aens 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 transmis missibility, host adaptation and vir le 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. kawayoka and fushai 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 oner iffet 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

virulance 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 committee 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 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 expiriments 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 acdamia, 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 aiskt 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