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

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 serveds 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 nonedual-use resear. when we did the extramural sbrrnt 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 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 avian h5n1 virus. it's 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 or durc, as we've been saying, to distinguish normal research from that with high potential to be misused. the parameters defining durc would include the magnitude any of danger, and the immediacy of any threat balanced against the overall benefits of the work. over the last eight years, the board has advised u.s. government on best practices and policy approaches for the -- for research communication, personnel reliability standards, codes of conduct and international engagement for issues associated with durc. the board is recognized a 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 to 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 eight-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's unanimously recommended against the publication two of scientific papers in november of 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 recommends to the government that key elements of the studies not be published and only redacted papers were acceptable for general distribution. these recommendations were based

upon the board's finding that if this avian influenza virus aquires the capacity for human to human spread, and retained its current virlens, the world could face a pandemic of significant proportions. the risk for public harm to be of unusually high magnitude. the board has published its recommendations to the u.s. government along with its rational. importantly, we pointed out that an international discussion was needed amongst multiple societal components to develop policy on this arena of high consequence durc. i would further note in the few months since the recommendations were released there's an a flurry of u.s. and international meetings to discuss the risks and benefits of these experiments. the research issues and policy consequence are now commonly known in being debated. this continuing global conversation is important for the scientific endeavor and for our biosecurity. in late march 2012, the u.s. government task nsabb with

reviewing revised versions of the two original manu scripts. this was coupled with a face-to-face meet toeg the board could hear directly from the investigators about their research. in this meet, the board received nonpublic information about the risks and benefits of the research from the international public health and research community as well as from the united states government intelligence community. in a classified briefing from national intelligence council and national counterterrorism center representatives, the board heard and 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's 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 nasbb's

own definition of durc and seven categories of experiments that warrant special consideration and targeting particular high-consequence pathogens. it is in this consequence the board arrived at different recommendations for the revised manuscripts. one paper was unanimously recommended for full publication while the other recommended by a split vote of 12-6. and balancing the risks against the benefits of the revised manuscripts and 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 vote forward publication but they were clearly still troubled by thissy is search and its potential to be misused. it is fair to say 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 we'll be dealing with it again in the future. it is critical that we establish policy that intensely monitors high potential durc research from kradle to grave in order to protect us from misuse, but also to free low potential durc research from onerous regulations. we must be careful we don't destroy the enterprise as we protect against a misuse of some research. thank you. >> thanks very much, dr. keim. let me ask you while the phrase is in my mind. what did you mean when you said we refer to undesirable political consequences from not publishing? >> well, so this was in the classified briefing, and so in this environment, we can't talk about it in detail, but there are many international collaborative projects going on in public health to try to control and predict and understand influenza pandemics. many of those political agreements are very fragile and i think it's fair to say that

not releasing this information was seen as having a detrimental effect upon those fragile -- >> understood. okay. thank you. final witness is dr. thomas ingelsby, chief executive officer and director, center for biosecurity, university of pittsburgh medical center. welcome back. >> mr. chairman, thank you for the chance to speak to you today. i themmy director for the center for biosecurity of upmc. i am an infectious disease physician by training and have seen many patients with influenza die, despite excellent medical care in american hospitals. for many years, my center colleagues and i have been studying avian and 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 fouchier

manuscript. just as it kills ferrets when instilled into their tracheas this engineered virus also kills ferrets the same way. so there's no evidence that i've seen publicly presented that this engineered virus would have less virulence than h5n1 would. were it to cause a human infection it could acquire new virulence properties. if it led to human infection, we can't rule out the chance it would lead to high case fatality and spreading epidemic, doflt st stop. there are others in the scientific and health communities who share this concern. that said, i appreciate that a deliberative process has taken place in the last six months. the majorities of nsabb members, u.s. government agencies and the journal "science" have decided that this work should be published. i'm concerned about this, but i recognize this decision has been

made. so now it's time to look ahead and anticipate the future of h5n1 transmissibility research which scientists are poised to pursue. here are some brief thoughts on benefits and risks of further pursuing this line of research. will further engineering h5n1 transmission improve surveillance? genetic mutation data is not widely collected in avian flu surveillance systems. very few sequences are annu s a in realtime. 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 meaningful and have value to lead to additional action if the field, this research seems unlike three practically improve surveillance. nor is this research necessary to making h5n1 vaccines for

reasons i explain in my stomach. what could go wrong with transmissible h5n1? could an accident occur? biosafety at modern labs is generally excellent. accidents are uncommon and most pathogens have little for societal spread. but the accidental escape could result in catastrophe. although it's uncommon, accidents do happen and 1977, h1n1 caused a mini pandemic probably from a lab escape. nine years ago during sars at least three incident in which researchers working in labs accidentally infected themselves with sars. i'm 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're human. we have detected the possibility of human error into our research. can we assure it won't be replicated and deliberately

misu misused? we can hope they won't have the competence or intention to pursue this but can't accurately predict the chances this will be rep layicated by a ma replicated by a scientist similar in the world, war terrorist group or nation state. what happens if a trans missable h1n1 starts to spread? the case fatality rate in the database is nearly 60%. if a strain with that fatality rate were engineered, hundreds of millions of peoples lives would be at risk. so what should be done about the research going forward? first, i would extend the moritorium discussed. the reason many agree are still valid. we should have more confidence this research will lead to practical benefits and we should look for other benefits that

don't require engineering. if this work is allowed to continue, we should limit it to the smallest number of labs. the u.k. and kiwanucanada have d it can only be done in b4 labs. second, let's decide if there are red lines that shouldn't be crossed. for example, should increased lethality be transmitted to understand vary lance? should the strains be engineered to make them resist sant to antivirals. we should decide now and third, the u.s. should continue to strengthen its pandemic prepardness efforts. universal flu vaccine, antivirals. preparing for pandemic is

critically important. returning to the policy for verge of concernunced. this is a good step towards addressing the controversy. the success of the policy will depend upon how it's implemented. i'll highlight four here. number one, implement effectively at the local level. scientists will institutions with the crucial to the success. this is new territory for them so training and education will be key. they'll need new members and a clear process for elevating concerns. two, learn from experience. this process will need to evolve as we learn. i understand that the review of the portfolio warranted further risk management. it would be a valuable learning tool to understand these ten cases. what caused the concerns? how were kis ks mitigated? this could be done in a twi protect the sciencetists. it would be useful to learn as much as we can from the risk

management process. how were risks assessed. going forward, the success of the dirk 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's already navigated. i recommend asking to examine the existing effect is. and last, reaffirm the rule of nas nassb. it deserves a lot of credit. members have done substantial public service and prepared valuable guidelines and spent time on this debate and independent and strong nsabb could have an important role going forward and i hope that the nsabb will rarely be in the

position of process after man scripts have been submitted. the process should happen early in the research process. to conclude, scientists who research diseases are are working to better the world. the u.s. needs to continue supporting entrepreneurial and ta talented scientists with the best ideas. at the same time, we need to acknowledge the consequences of accidents, special processes are needed to manage the public. this policy is a good step in that direction. >> thanks, doctor. help us just to, lay public, including me. when we hear about accident ales cape of pathogens, we get alarmed. talk more about it. does that normally happen? infection of workers? or -- >> yes. in all the cases i mentioned an

other cases, that is typically the way that people, an infection would escape a lab. the laboratory would get infected. usually, they don't spread it to anybody else. so the risk really is is to the person working in the laboratory. it's rare for the laboratory an to pose a risk. >> i assume that all the regulations both before and after march 29th were intent on limiting the possibility of expo shoour to personnel. >> definite l i mr. chairman. in general and specifically in the two cases that were discussing as prototypes here today, the two laboratory, one in wisconsin were very, very high highly qualified. inspected multiple times and given a rating of meet or exceed the kind of standards we're talking about. >> 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 irasmus? >> the underlying science and approach they took for these is different. they get one together and so one a approach was viewed as a greater control of risk. that's one of the aspects we have instituted across the board in bio safety experiments, to try to do these in a context that's less dangerous. for example, if we do an experiment where we're going to add a gene, usually, we like to do that with a pathogen that has been disarmed before we get there. distinguishing the two groups, trafs the biggest difference.

one worked in a platform viewed as less risky. then the other one, taking really the wild type, the raw material from nature, then changing the trans missablety on that platform. >> if i understand that difference, working with the scientific decisions of each team as opposed to differing levels of safety standards they were operating under in their respective institutions or countries. >> so as dr. foucher pointed out, both institutions were heavily regulated and reviewed. both exceeded the requirements for biological safety that we have in place for these types of experimen experiments. >> okay, dr. kind and foucher, i want to give you an opportunity to respond to the descent in the

letter, a confidential letter, then was leaked, from michael ostraholm in his criticism of the nsabb decisions and to some extent, not totally reflected by dr. engelsby, but also expressing some concern. dr. penn, why don't you again? >> first off on the committee, we are a board of 25 highly qualified individuals and we rarely agree on anything. >> sounds like congress. >> i know. >> although we may not be highly col colorful. >> we actually embrace this and use it and we cherish the members and this particular group as well.

this was a letter meant for an internal process for us to understand in a retrospective fashion what we did come through and as a very constructive type of communication. it was you aren't it was leaked and became part of the public dialogue. makes it harder to have a constructive type conversation. in fact there was a bias in the witness left. i think that is true. the primary witnesses that we brought in for this hearing were ine investigators themselves. they're inherently biased. they wanted their work published. we brought in a second investigator who's been collaborating them and working on how you use this information for surveillance purposes. again, somebody who would like to see their work published and seize the benefi