Event Started: 6/30/2005

I am the chair of the committee and I would like to welcome you to the first meetmeeting of National Security Advisory Board for Biosecurity. Dr. Zerhouni will give opening remarks.

I appreciate it. I am the director of the National Institutes of Health and I am happy to be here today to launch the key component of the Biosecurity initiatives in the life sciences. As you know the U.S. government created the board to provide advice, guidance and leadership regarding bio logic research and could pull the biologic trets to national security. Clearly, this is an issue that is novel in the field of science and particularly in the life sciences and particular with where dual use is of concern both from the standpoint of Biosecurity and from the standpoint of free dissem nation of useful information to the public. I have the privilege of being established in the and the many trance government that proceedproceeded. To establish the board. And I am really pleased to be here to help launch the work of this very important committee. I think you members of this committee know that the benefitbenefits of scientific discovery of global cooperation of the exchange of ideas across borders are endsless and if you look at the International scientific communityies rapid effort to identify and in sequence the SARS package in less than a month. I was with a record time. Using all the technologyies to all of us and across the borderborders in China, partly at the world health organization, D CDC and I H. We can see the power of to disseminate relevant information o on a timely basisbasis. There is no doubt that Biosecurity measures for controlling inflew whence is a today is an another example of why we need free rapid dissem nation of information so we can act on it. The collaboration that enabled the chain reaction for fungal and soybean crops. Is another example where there is a public good that was achieved. Or the national effort that led to the genome. It stems from the long term and sustained investment in basic and and applied research across many government agencyies from the free agency of ideas and across the world. Recess programs are aimed primarily at extending the knowledge of the human body and the multitude of organisms with which humans interact and depend and from the research we can gain all the tools Dick diagnostic and that we made we may needneed. So how does the NSABB fit into the picture and how it is now. There is foe doubt in fundamental science for the benefit of man kind has also created tools that have incredible capabilityies for mischief. Because of the decome bin nant research and other life sciencesciences disciplines, we have come to the root, the real root of life systems in biological systems and there is no doubt that offer the past 30 years from the day recombinant techtechnology became available to us. There are eastern concerns are about the misuse of these tech knowledges and we have an increaseing ability to retunely alter biological systems obviously to explore the medical electric lar organizeismorganizisms of plant, animal and disease. Yet, it is an unfortunate fact of life that there could be individuals out there who would use these very technologyies and discoveryies towards more sinister ends to terror eyes nations and threaten public health. Accordingly despite the goals and attention in life sciences research conducted to enhance the quality of our lives. Concern is raised that this information could also be misused and because of that the Department of Health and Human Services and the National Security Advisory Board were asked to be the home for this committee. We have greatly expended our bio defense programs at NIH to counter the necessary against bio terrorism and this threat could not be tackled unless we had a complete engagement of all the come money components of society that is necessary to provide the wisdom for the country that will be necessary for us to find there is no doubt that the kind, the spectrum and responses that one could adopt in the context of threats like this, has to be carefully measured.The response to the be more good than harm.Response to the threats has the potential of doing more harm than good.Our nation's response to stress is necessarily a response that has to be coordinated and measured but also enlightened by provided through the common wisdom of groups of citizens like yourself with the expertise and with the common sense that needs to be brought in to provide guidance to the rest of the country in the context of providing a safe harbor for good research and an unsafe harbor for research practices that may in fact threaten us.So the dual research phrase has been coined that has legitimate scientific purpose but has been misused to public health and the national security and the concept could apply to many other types of research but the specific criteria are yet to be defined and we are counting on you to help us do that and this clearly one the first issues that the board will have to consider.It is important to bear in mind that scientific intent distinguishes dual research from others that can be used for mal leaf purposes and the work is under taken for scientific purposes rather than deliberately cause damage.The creation of this board is a government wide effort to address this very significant and important Biosecurity concern in the life sciences.This will be a significant challenge for you, members of the community.Man of the ditions you will make will be very public.The rational and the process by which you the decisions will scrutinized much like the decisions themselves.We want to adopt a very open and public the extent that we can without jeopardizing security.It the sharing.Because it is the sharing of information and materials and technology that is the foundation for the life sciences, and notebly the participating departments and agencies that are involved in such committees are all committed to striking a balance between the needs of scientific progress and Biosecurity and this is reflected in the fact that the board has been recommend, has charged recommending a set of guidelines and with promoting a of responsibility.Let me stop here because there is no set of guidelines that you could develop that will be successful if at the end of the day a culture responsibility is not established worldwide across the community of scientists.Because at the end the day, it is my personal belief that the goal will be achieved when a scientist himself or herself asks themselves a question, could this be misused?What could I do to protect that from happening?That culture of responsibility is probably the task all of us as leaders of and of this committee are going to have to develop and find way to get to.And this is was to Dr. Cast per before the opening of and mentioned him that communications from this board to the scientific community are going to be a important component and the strategy for ininvolving the -- involving the leaders across the world is something we would like to hear from you about and we are very prepared as the director the are very prepared to support in fact, the establish meant of such a culture.A difficult task.There is no doubt that existing laws and regulations are already in place that speak to critical aspects of Biosecurity for a particular sub set of research and involving select agents.And these have been enacted already and for intent, the purpose of protecting the American public from the misuse of these agents through acts of terrorism and in so, we have created a frame work of law. The U.S. patriot act was the first to use pat generalic path general ic and who should be working with the agents and it establishes personal liability in certain cases and select agent work.I think it is clear that the is using the means that it has to to limb the risk of -- limit risk of Biosecurity of Biosecurity threat.The public health and boy KWRO*E terrorism response act of 2002 and the agricultural of buy KWRO* terrorism act of 2002 updating the rule by requiring research facilities to register with CDC or USDA if the use select agents on the agents of select oghts.In addition the select agent rules require safety and plans for institutions that work with agents.There no doubt this could help address the Biosecurity aspects with certain path general I path generalic organizisms while allowing the tools and vaccines.But this is not enough. Protecting our nation is going to have to be in the sex of Biosecurity is going be a dynamic process.The NIH established many years ago went through a process of evolution and this is why, I think this is why this board really needs to lock at its work look at its work.Evolution will and hopefully you will evolve guidelines and rules and new culture of security faster than those who want to misuse this.This is really the challenge.Rigidity is probably not the best answer.But evidence based, wisdom based, aggressive approaches to this issue is something we need from you and your advice at this meeting and these meetings is going to be listened to and be critical.Today's inaugural meeting will definitely help strengthen the Biosecurity.We are fostering the life sciences.Your charge as established is to specifically advise the government on this critical issue and to recommend strategies for the efficient and effective oversight of federally conducted or dual use biological research taking into consideration both national security concerns and the needs of the research community.This is your official charge, ladies gentlemen.The new policies and oversight practices that result from the recommendss from the NSABB will comply -- compliment the initiatives mentioned.I want to first all of who participated in the conceptualization of the NSABB.I see many colleagues from many various government agencies and departments and to thank them.This was not task to come up with a recommendation for the president to follow and I would like to commend the expert members and ex-officio members for agreeing to serve on the NSABB.You have all been appointed to this important committee because of your nationally recognized expertise in your field and analytical and problem solving abilities.Dual use dilemma is a dilemma.It is a public pog policy challenge and important for the society.We need your wisdom and good judgement, we need your help.And you need to find the right balance in a multi para metric dimensional problem because it is not just a scientific problem.This is one of the most difficult things you will have to do.Cannot only scientists but being citizens of our great country.So, I would like to ask you this point to stand up and look towards me.I going to swear in all the members.You have received your charge.And if you can just look me and sit up.I would like to ask all of you to raise your right hand and repeat after me.

I do solemnly swear.

That I will support and defend the constitution United States.

That I will support the and defend the constitution of the United States.

Against all enemies foreign and Dom domestic: I will bear true faith and allegiance to the same.And I take this obligation freely.Without any mental reservation or purpose of evasion.And now, I will well and faithfully discharge the duty of the office on which I am about to enter.Thank you very much for your willingness to serve the country.To all of you, I would like to bring the thanks of the secretary of health and human services and all the agencies and departments of the government and to thank you for your willingness to serve the people.I really look forward to deliberations and tomorrow and really look forward to receiving your reports and recommendations in the future as Director NIH, I can tell you everything you will communicate to me will be taken very seriously.We diffuse those recommendations and guidelines as well as we can throughout the entities of government the stakeholders.If you look at the world of science, you realize that it is also a global world and clearly we will need from play out the role on the scene.We are at NIH are proud to serve as the NSABB and we clearly are looking forward to serve you and support you in very, very important deliberations.I was talking to the NSABB chair, Dr. Cast per, I know he is ready and he has identified some the hot topics including ones that showed up in the press recently and I know be a great and able will have him go into more details about the meeting agenda and next two days an over view of the responsibility of the board members.Dennis?

you very much.

Well, Dr. Sue hiewn Zerhouni thank you for starting the meeting and giving charge.On behalf of the committee, I will accept your charge.It is a significant challenge we have ahead of us but I think my colleagues are up to the task and we are willing to put in the work and effort that is need tod help define what to be defined for the area of Biosecurity.I would like to just start with introducing myself just briefly and in a little while I will ask all of my colleagues to introduce themselves.I am professor of medicine and microbiology in million molecular genetics at Harvard School.I am chairman at Brigham university in Boston and director of the New England center for excellence in biodefense and infectious diseases.My research interests are in microbial immunity.I have expertise in carbohydrates and long-standing interest in vaccines particularly guy coconju gant and the organizisms I work with are strep toe cok cuss and and more recently with the organize aism Frances sell la.One of the agents of potential bioterrorism so that just gives you a little insight into what my scientific expertise is about.I would like to welcome the board members the ex-officios and the public in attendance as well as those watching the proceedings by webcast.I just want to go through some of logistics that will occur over the next two days.Because there will be presentations and issues that some of us may have considered in great department this yet many others, these will be completely new topics. from speakers that the broad of expertise from academia, the buy technical industry, the public issuing industry and the government on issues of Biosecurity and public health.The varying perspectives of the speakers as well as those of the board members serve as a great resource from which we will all undoubtedly benefit.I would like to give a brief overview of the agenda of meeting.Board members should refer to the agenda in the table folders.Today we will first hear about the national science advisory board for Biosecurity, purpose, structure and operations.Subsequently each member will have an opportunity to briefly express their view on Biosecurity in the life sciences.This afternoon we have a session on the development of criteria for identifying dual research and research results.This will be followed by Dr. Anthony Fauci speaking on balancing scientific technology and the need for a culture of responsibility.The second session will be for communication for dual research and technologies.When we will meet tomorrow, we will hear from speakers on the codes of conduct in the life sciences, International perspectives on dual use research and the chemical synthesis of bacterial Gene Nomes.There will be a general discussion and question period for board members and speakers.Throughout the meeting.We will bear in mind that a given topic or term may have a different meaning to another individual based on their experience and of view.Typical example is the term dual use which we are going to learn has many meanings depending on your line of work and the organization.Coming to common ground on this very concept is of primary importance.And at the end of each Kay will conclude with an opportunity for public comment.In order to provide public comment.You must have notified the inexcept staff or if time permits we will allow those who have not registered to make a statement. would like to make public comment.Give a comment to the person at the registration table.My role as chair is to oversee the conduct of our meetings. The inseb has been charged to recommend on policy to issues related to Biosecurity and public health.We will hold regularly scheduled meetings.However, the secretary of the U.S. Department Services left leaf vit inseb deliberations and guidance.We have a number of tasks of us. to facilitate our work and in a timely matter. be forming working groups that will have specific areas of focus.This is on dual use research.Communications and codes of conduct and International collaboration and synthetic gentlemen Nomics.These will be proposed of present and ex-officio board members outside experts.The board is expected to confer between the meetings and to develop draft work products for the board such as position papers in collaboration with inseb staff working at NIH.They will present your recommendations to board.It will the entire board that decides on any products that will be put forward to secretary leaf vit.And his colleagues and other federal departments and eaves.It important to emphasize the entire board will be involved in every decision.The entire board.As we begin exploring the issues charged to the board, I would like to ask the members to begin thinking about the working group in which you would like to participate.We will to the task of forming the groups as part of the closing session tomorrow.Before the board members introduce themselves please be aware there are 45 minutes to introduction and we have 43 members.So let's take a minute or so to introduce ourselves.Our field of interest and other advisory committees etcetera.Please be advised the opportunity we will have to express our points on Biosecurity is coming up later in the agenda and we can reserve discussion of these issues until then.Three members could not be with usThey are Ann, and chair Department of Plant pathology.She will be with us tomorrow.Dr. Claire genomic research and Dr. Shank biology at princeton.They reinforce the fact that much was extended of effort to select board members with a broad spectrum of knowledge and proficiencies.As each briefly introduces themselves, you will know the department of the expertise and breadth known own inseb.I would like the ex-officios mention how the respective departments coordinate with INCEB.I need to leave the meeting temporarily.In my absence.Dr. Paul scwap kind will chair and we will work our around the table.

Paul?

I am the director of path general general mom Mcs in Phoenix, Arizona and I hold the chair in microbiology at northern university so I worked in research institute as well as in ak ceemia, my interest has been in general Nomics and how you translate that into diagnostics and into forensic analysis.My laboratory is actively involved in investigating the Anthrax letter attacks and still does today.We face the question of dual use on a regular basis in my laboratory and have to make decisions in both in the laboratory concerning what we do, we have to face decisions on when we publish and how we publish, the same time how we move the science forward in order to help the country. I am looking forward to work through the issues in the next coming years.Thank you.

I am Jim Roth, I am veterinarian at Iowa state college of medicine.My area of is infectious disease of cattle and swine.My first 20 years I worked on domestic diseases last or five years I am interested in vaccine for foreign animal diseases which are a public threat to public health and food security in the U.S.I am director of the food security in public health which is CDC specialty in soo logic diseases and policy, blue ribbon panel on counter measures and chaired the vaccine subcommittee.

I am Mike and director of research and policy at the university of Minnesota as well as national center for food defense.Excellence also at the university of Minnesota, I have been there since 2001, prior to that time I was at Minnesota Department and in addition to that, also as special advisor to Tommy Thompson to 2001 and 2004 in the areas of bio terrorism.My become ground is infishtious back ground and preparedness and been involved in the area of bio terrorism dating back to 1990s.

I am John Lumpkin senior president of Johnson wood foundation.Prior to coming to the foundation.I was public health in the state of Illinois and I practiced as an imagine emergency physician.I chaired the national community for vital health statistics ment secretaries to the health policy.

My name is Stuart Levy.I am currently frofer of my crow biology and of medicine at tufts school of medicine direct the center for drug resistance and my main interest has been antibiotic resistance.The field I have been in for 30 years.I cofounded the alliance for use of antibiotics.It is both beverage science and public health.I served as consultant to world health organization.The F.D.A. and many other government agencies including NIH and I pleased to be here.

My name is Dave franz, I am senior scientist at the research institute in Kansas City and served as director the buy security center at Kansas state university.I army career for 27 years.The last 11 of that were at fort death treek at fort DIETRICH and I served on the committee that was involved in the developments that led to this committee.My name is Barrier lick and I am president of BJ associates and I was advisor to the deputy secretary of the secretary of agriculture for Biosecurity and previously I had spent 25 years in the intelligence community dealing with specifically dual use issues primarily in the biological area and that this has been a major concern for a quarter of century for me and longer.My background is molecular biology and I hope to bring some of this expertise to the group, thank you.

My name is admiral bill studioman.U.S. Navy retired.And also I am a career, my government positions include deputy director the national security agency, director of naval intelligence and some other positions member of the defense science board and just recently completed a 15 months being a commissioner on the presidential commission on W MD.And my concerns have to do with optimizing the role particularly in this of transformation for the intel committee and director of the national intelligence in terms of how it plays its role in Biosecurity.

Mr. Chair, shall we continue the other board members before we move to the ex-officio members?

I am Diane worer.Professor of pediatrics.The director the children's clinical research center there in the division chief of pediatric immunology.My research interest are in pediatric HIV specifically trance mission of HIV and strategies to prevent trance mission as well as path genesis to primary immunodeficiency disorders and strategies for reconstitution of these disorders.I currently the chair of the recombinant DNA committee and I am here to represent the committee and act as a between enseb and the RAC.I am Harvey Ruben and medicine and at the university of Pennsylvania.And I am the director ofpen's continue stie tiewt for threat response.Which is a school consortium of faculty and students doing everything from risk and how it plays into security and strategy issues.My interest is biochemical of enzymes that are in tuberculosis and category C by agent and we interested in how the biochemical intichs get turned on and off as micro bacteria and tuberculosis goes through the life cycle dormant and for activation.

I am Mike and of microbiology at the university of Michigan medical school.My research interests are in DNA tool of viruses and life cycle and how they contribute to cancer and more recently we moved into the field of viruses for delivery and I currently sit on the laboratory steering committee.Also the chair of the institutional bio commission.So between my own research and serving on that committee.I get to see a lot of different manipulations various viruses and bacteria and I hope to be able to contribute to that committee through those efforts.

I am David rel man associate professor of medicine in microbiology in stand Ford university and infectious disease clinician and on bio safety my.My research interests have to do with Mikeee biology of the human body as well as path pathogen diversity and host interactions.My service and interests in the areas of dual use and bio -- Biosecurity involve a variety of functions to the U.S. government and various agencies having to do with the potential developments in biotechnology that have to threat say health and misuse and I currently cochair the committee of national sciences with another member.This committee is charged with a look at the future of biotechnology and its potential impact on biological security and misuse of biology, etcetera.These issues that are relevant to this committee as well.

My name is mark nans, I am an attorney in private practice.Corporate and intellectual property law with a on biotechnology.Currently the counsel discovery systems for E care.Prior to that was affiliated with a company focused on the environmental and IVD nuclear acid based detection of biowarfare agents.

I am a physician in infectious disease specialists.I run vaccines at the company ipg.And we have several vaccines that translate most of the findings of physics into agents that we use to protect our people in this country and globally.My interest in that area relate to say 25 years previously in ak demic medicine on pathogen relationship.

I am Stan man a physician trained in infectious diseases and internal medicine at the university of Texas branch in Galveston.Where I direct the U M B's I am unity.The institute manages the containment laboratories that do research.That include quite a bit of B S L three and functional B L four space and investigator for national laboratory. One of national containment laboratories under construction with funding from the National Institutes Health.I coach here with him on the committee he mentioned a moment ago and also serve as advice chair for the forum on micro bile threats on the institute of medicine.

I am retired air force.If my friend bill sued man's career on spook.I am the career policy WONK.I spent 32 years in the force and in systems and my last job was as director, deputy director of central intelligence.Couple years with the Department of Energy and last two jobs in government.Chief of counter terrorism at the White House and president's home land security advisor for a year.I first became interested and involved in the subject of the commission also and helped to bring that report into the White House and get some light on it.Thank you.

My name is Lynnen quis and I am the professor of pass proz of the American society of biology.I am a board member of the American -- the triple ASand chief of the biology.My career focuses predominantly on running a laboratory to study the pathogen sis of the peerp piece virus and I am spent my career in three areas.I worked as a staff scientist in the NIH developing a lot the in the recombinant and small biotech company to develop animal virus vaccines.I was a research leader at Dupont and senior research fellow at Dupont PH*ERBG before I went to princeston to run a laboratory.One the things I am quite proud of and reason why I am quite interested in the issues at stake here at the American society for microbiology, of biology is one of 11 journals and about four years ago we decided as a to instill a of our membership to public and will be talking a little bit more what done.The journal of biology example, we have looked at over is 15,000 man new scripts and with the light of understanding the kind of science that is there.I will be telling you more about it as we move along.

Good morning.I am Murray Cohen.Retired public health service officer based in Atlanta.I serve as independent consultant but as president of the front line safety foundation.Public not for profit engaged in training first responders and first receivers in disaster management and mass casualty management and sort thing.Currently I am very involved globally in risk assessments and threat assessment for high containment laboratories.I am very involved with and concerned about training people to work in the laboratories and imaginage these laboratories effectively and safely.Thank you.

I am Andrew sore ren zone professor of epidemiology and president of South Carolina.I served as executive director of the Aids instate tiewt at John Hopkins medical institutions and since its inception served as member of the secretary's council on preparedness and bio terrorism.

Ex cove fish members.

I I represent the USDA as ex-officio member administrator of the agricultural research service and charge of program planning.My background as a scientist is trained as a preproductive biologist with most of my career working on animals and genes and protect against infectious diseases.Today we are interested in the acts of the committee because of the tremendous drive that general moment gene OEMics has and with the tremendous increase and emphasis on counter measures various threat agents we see the likelihood we be in some areas of very sensitive research and to the advice from this community.I am March rye Anna car heart.I represent the association who is the assistant direct of the National Foundation for the biological sciences.I am the director of the division of molecular and bio sciences which means I oversee programs in the traditional disciplinary areas of bio chemisttry and genetics and gentlemen Nome Mcs and gee Nome Mcs and in sequencing in a promise we have called observe tourist both of which we are doing in collaboration with the Department of Agriculture.We have another program I oversee which called ecology of infectious diseases.And the primary mission is to see to the long term welfare of fundamental sciences and on fundamental science.

I Terri low max.I deputy administrator for research at NASA and impart of the expiration system mission director.We have the for all of the human and biological space research at NASA and am from my home institution which is Oregon state university where I am professor of biologien and prior to coming, I was in the program for biology issues.

I am Ron Walters and molecular biologist and work in the innovation center that is the office of the director of national intelligence.I represent the intelligence community and the programs in which we work are countering biowarfare and bio terrorism.

Good morning.I am Larry Kerr in policy House.Molecular training and our office is engainled in a wide variety that is in the federal agencies.Miewlt tiewd am Homeland Security issues.

Good morning, I am biter director and chief scientist of the home land security research center.An agency that has responsibilities in drinking water protection.Decontamination and risk.My academic training is in biology and math mat with work in and infectious disease.I serve on the science advisory boards of several other parts of the government and intelligence community.I am in an agency with a 30 to 40 year commit ment to open science and sharing information with public.In fact one with a legal mandate to do so.Yet my center regularly faces dual use and sensitive information release issues.Our mission is to protect the public but our work is often a road map action.So we are very interested in the advice that we can glean from the work of committee.I am Brenda from the Department of Veterans affairs office of research and development.My primary areas there in policy development related to bio safety, Biosecurity, our B S L three program and select agent use.I am also developed policies in the areas related to human subject research and conflict of interest and I serve own a of enter inter agency and Biosecurity and my background is in occupational environmental health.Good morning, I am John turner, I am an assistant secretary at the U.S. state department.I oversee the International health office which has responsibility over infectious diseases.Other than HIV, malaria and TB and we also have oversight over environmental health and represent the secretary on Biosecurity issues.We also have the International lead on science and technology, agreements around the world and for some of our sustainable strategy dealing with access to sanitation and hygiene and dealing with water bornE diseases.I have to admit those scientific credentials wandered off years ago.

Good morning.I am Scott representing the S B I.My background is in genetics and I completed my degree in princeton and particularly in increasing out reach between the scientific and communities.At FBI I am working on measures, programs particularly working with other federal departments and agencies to examine programs for surveillance detection and response to threat of WMD and several bio defense initiatives including the one that led to the creation of the NSABB.Thank you.

My name is Rick Carney.I am a biologist and Dr. ale hiem with the U.S. geological survey the Interior.As the dns science bureau has the ability to provide the information necessary to protect the health and welfare of the national visitors to parks.As well as managing the 1/# five of the Department of Interior -- 1/5 of the Department of Interior.And that is the study of the native communities and that of human and agricultural animal communities and we look forward to advising learning this panel.Thank you.

My name is Jerry parker I am from the Department of HomelandSecurity and development and research and science and technologyI retired from the army about a year ago after 26 years, spent a lot that time in biodefense research from diagnostic drugs and in path though nis yo logic mechanisms.

I am Jan Nicholson, I am the associate director of lab tore science in the center for infectious diseases, the C.D. CDC, the I B C actually sits in my office.I represented my security in a variety of forms.Well my job involves issues in infectious diseases.

Good morning, I am Boris and captain of the U.S. public health service serving as the commissioner for policy at the nood and drug administration.Prior to that, I served with the centers for disease control and occupational safety and health.I medical center, physician, board certified in dermatology and preventive medicine.Represent the F.D.A. here on panel and looking forward fwriewp.The F.D.A.'s mission which revolves around safety of the food supply of the availability of the counter measures really depends on research to make progress in these areas and so certainly we the advice and guidance from this committee.Thank you.

I am Dennis Dixon and chief of the bacteria and micro boolg branch and had responsibilities with select agents and a lot of other activities relating to the key organizisms under discussion today.I am under Dr. Fauci who is the tore and will be joining us afternoon to comment on the involvement in this area.

Good morning.I I am David from the Department of Energy.I am the chief scientist from the office of biological and environmental research.The areas greatest interest to the Department of Energy with regard to this committee are efforts to understand develop comprehensive understanding of microbes.Microbes that could be used to develop biotechnology solution for issues.We fund a variety of research from DNA sequencing to technology development to understand and characterize all the proteins and regulatory networks and microbes and fun research you will hear about tomorrow in terms of sip thet particular gee Nome development and in other area of interest to the department which will get on the committee.

I represent the Department of Defense and I am the appointee in charge of the chem cal and nuclear biological Department of Defense.Prior to my ap point men, I served as advice chancellor of the university of Texas system.I am on leave from the university of Texas at Austin.My view of the world has changed some what from the of ak ceem why to we publish everything with starting my with an intell report and on those who want to harm.It is very sobering and it will be to strike a between the free flow information and protect the nation against those who want to do us harm.

Good morning.I am Dr. Stuart nighing gale I public health of emergency preparedness in the of secretary and health and human services.I am also the senior medical individuals or to the direct director of global health affairs.I am an internist and I have been involved over the years with medical administrative matters in the food and drug administration and the office of the secretary.Particularly between the issue and practices of regulatory concerns and recently os of course in the public health of preparedness of the C B R issues as well as the manmade or natural, rather natural disease problems such as inflew whence is a.I am also the HHS Lee ace son to the biologic at state department very cleesly with various parts of the department so I am very pleased to be part this group.

Good morning.My name is Vincent bill Kerr.I represent the Department of Commerce.We have two research agencies within commerce.One is NOAHand the second is the one where I come from the national institute of standards and technology. the biotechnology division.Some of the work that role, that of NIST is measurement and data valid dating both.What we bring to this forum I think is the reference materials that are used in DNA taping for forensic purposes and also by the Department of Defense for the human identification.In addition, we have identified reference materials in an enter enter inter national for P C R measurements which I think you might recall Dr. Seer hiewn any said is the one used in micro buyial identification.We develop reference materials and valid date procedures across a wide spectrum of technologies.In this case biotechnologies for the purpose of facilitating commercial application of scientific discovery or establishing societal good.Thank you.

I notice that Dr. Art tour row joined us.Would you introduce yourself.

Art tour row from the Albert Einstein college of medicine.I am the director of the infectious diseases and also a professor in the Department of Microbiology, immunology and office of medicine.I believe I am here in this community because of my expertise in micro interactions.Thank you.

Well, thank you, all for the introductions.I am very pleased that everyone will be able to participate in today's meeting and in future meetings.Now, I would like to introduce Dr. Thomas Holohan who is the executive director of INCEB.He give us an introduction to INCEBAits operations.

Dr. thank you, Dr. Cast per and and gentlemen, I am pleased to opportunity to provide a brief description of the purpose, structure and function of the national science individuals advisory board.This advisory board is established as a result of increasing concern that there exists a risk for the male volume length use and that the strengthening of Biosecurity initiative assist a prudent course of action.Over the last few years, the government has implemented a number of initiatives to address those concerns as detailed on this slide.And as previously described by Dr. Zerhouni, the patriot act of the public hement security and preparedness and response act and the companion agricultural bio terrorism act of 2002.And addition, government promotion and the conduct of research on the development of counter measures for biologic threats.The legislation has Dr. Zerhouni mentioned placed new restrictions on access to certain materials and in some cases imposed criminal penalties.In the same time frame, the national research council produced a report concerning biotechnology recertain and the intention for the research to be used for MALEVOLNEN purposes.This is a cogent view of an inhe is croog problematic situation.They especially employed the term for dual use for the scientific purpose and which could be used to improve wellness but also had the potential for misuse which would result in harm to national security or to public health.The report specified a of experiments of concern as arch types of dual use research.It provided a number of recommendations.These included of a national advisory board.And the report called attention to the issues of education and dual research and review of particular research proposals.Data publication and communication between groups responsible for health and for security.As you will see the charter of this board is quite comprehensive reaching all the recommendations and more.The national science advisory board for Biosecurity was established to advise the secretary of the Department Human Services, the and the heads of all federal entities that conduct or support life sciences research.To recommend strategies for the effective oversight of federally conducted or supported dual use research.Where dual use research as you have already heard and will probably hear many times over the next couple days is a legitimate purpose that maybe misused to in a threat to public the national security.Importantly the national science advisory board for Biosecurity will consider both the needs of the research community and the concerns about national security.There are a number of charges to the board.One general and charges.The board is charged to develop criteria that can be use tod identify dual use research and also to develop guidelines that can provide for oversight and that research and those research results.These are arguebly essential requirements upon which responsibilities of the board depend.The board is charged to advise on national policies governing local review and approval of dual use research to include guidelines for case by case review by institutional bio safety committees.The board is also asked to advise on criteria and process cease proses or processes or specific from viewers board itself.And these include the provision of review and guidance on experiment that may exemplify a per miewation of research or a new of dual use research.And addition, the board is charged to provide for a to a research institutions request for interpretation or application of the developed guidelines to specific research proposals that denied by an incity tiewtional bio safety committee.The board is also asked to provide recommendations on the development of a code of conduct for scientists in a laboratory workers which is intended for implementation and adoption by professional societies and by institutions engaged in the life sciences research.As well, the board is charged to recommend on the development of mandatory education training, in Biosecurity for those scientists and laboratory workers at federally funded institutions.And additionally charged to advise on national policies for publication and community tition and dissem nation of methods and the dual use research.The national science advisory board for Biosecurity is recommended strategies oversight of dual use research further, board is charged to advise on policies for the conduct of dual use research that allows strategies for allowing rapid scientific progress while assuring national security.A point emphasized by Dr. Seer hiewn any in Zerhouni in his introduction.There are other issues as the secretary of health services may direct.The board charter calls for not more than 25 voting members who are appointed by the secretary following consultation with other agencies and departments.And the board will meet quarterly and as needed by the secretary.And the meetings of board will be open to the public unless in certain otherwise determined by the secretary of health human services.And the board will be managed and administered by the national institutes of health.Office of biotechnology active its.-- activities.I am not going to read all the expertise on this slide.But as can readily be seen and as you have heard, this board is a distinguished group with extensive knowledge, skills and experience.It is of that these capabilities are broader than those ordinarily represented on bio medical advisory committees and include individuals with previous fish ens si in areas such as security and intelligence food production and law and scientific publishing.In addition to the voting members there are 18 ex-officio members who represent the federal agents and departments from have just heard.These individuals will assist the board members by serving as a resource for unique expertise and experience as the board deliberations reach to their organizations areas of responsibility.The will engage bio safety security sciences research and public communities in the board's activities including development of the guidelines, codes of conduct and the training programs previously mentioned.The board will recognize and develop strategies to address the significant challenges that will be faced by researchers, institutional bio safety committees.The leadership of institutions and research administrators and publishers.I that the board was administered by the of national institutes of health, Office Biotechnology and our assignments really are to manage the NSABB on behalf of the department.We will plan and execute the meetings, develop background materials and provide support the of work products of the board to maintain the website of the board as a resource for the public.To identify and analyze dual research issues which we believe are likely to be a continually moving target.To facilitate coordinations of the development of federal policies regarding dual use research.To participate in the implementation and the interpretation of the guidelines developed secondary to the recommendations of the board for dual use research and to develop training and education programs for institutional bio safety exiet tis who are involved in dual use research.The national science advisory board for Biosecurity has its own website and the website address and E-mail add rest are listed add rest are listed here and they will provide functions for the to the national science advisory board for Biosecurity and you see here our phone fax numbers and our phone numbers.Thank you for your attention.And Dr. CASPer do you wish to allow the audience to take a break.

Why don't we see if there are any board members that have questions for Sure.

Please feel free to ask questions.The large charge have.Either the presentation was very good or their intrinsic brilliance is satisfied.

will see.We will reconvene at 9:45.We We are running ahead of schedule and give us time for discussion after the break. you.

I would like to give INSAB members and ex-officios to comment briefly about Biosecurity issues in the Life Science area of research.I will start by reeding a statement reading a statement by Ann, who will here tomorrow.I reading her statement now.To paraphrase the wife of a founding father of the country, and I would remind people not to forget plants which are the base ils of all life on earth.I One of the crops is soy soybeans which just enter the country last year is expected to be a challenge at many levels including that there are no commercial variety without any resistance.Community cition and interaction with clinical scientists with plant pathologists and poght owe poght generals poght though generals of plants that are or can multifly antibike or antifungal resistance.So that everyone has an opportunity to be heard, I ask that you limit your comments to about three minutes at the most and I going to ask secretary turner to start.

Well rtion thank you, Mr. Chairman.As said introduction, the state department's role is to work all you and facilitate and in molding the strategy and implementing it.We all recognize that the purpose of which we are organized here is trance national in its scope, so if we are going to be successful we have to transmit a new code conduct on the enter national community and -- inter national community and our goal is to work with all of you to first increase International awareness and do we motivate allies and folks who aren't allies into what is the best interest of the American people.Interestingly enough, I was at two forums yesterday which are different but the related questions.One is before the chairman HYIE's community committee in the house and in the afternoon a meeting at the White House as we trying to mold an International strategy for engagement as we deal with flu, inflew is a, some of the questions we would look at what our specific goals internationally might be, what enter national pathways do we choose to transmit what we the committee.Forums, like F A O, and what others, like the G eight or the global health security action group, some come to mind.What specific countries would we want to Bank of New work by laterally with, either countries that are our allies or sensitive states and states that might be high to the United States in the arena and the research arena or how do we deal with the state's in between.What is our message to those states depending the audience.What resources are to share with other countries as we work to protect American citizens in our food supply and our economy and our culture and social values. we be interested in collaborating on including the very sensitive areas of counter Miss Sures.So we look forward to working with all of you as we have two offices.One works with infectious diseases and the other takes diplomatic lead on technology agreements in cooperation with all of you so we see the NFAB as an important step forward as we look for the health and cooperation of the scientists and secure a better and more stable future for American citizens and the global family.Thank you, Mr. Chairman.

Thank you.I think now, we will turn to the board members, and ask each to give their view of this area.One issue that has been brought to my is apparently the folks sitting in the back of the room are sometimes having trouble hearing people speak, so if, can you hear me speak in back room?Okay.So if you just make sure that you talk into the microphone, that would be very helpful, I think.Paul, would you want to start?

I would just like to remind everybody what to lose in this process.The United States scientific community and the European world community has really generated enormous amount of progress in the last several decades and this is really been based upon a competitive and interactive process where information was free to flow not only to the clob bore rate tores but to the competitors so any progress you make might be instantly peer reviewed and critiqued and in a scientific dog fight, if you will.In the process of increasing security, it is necessary to begin restricting certain as he aspects of this.If we don't do this carefully we run the risk of losing what is the scientific engine, the world has ever seen and in what really viewed as a race as opposed to all or thoag type situation where we are racing against bio terrorists and people who are against our society and country.In a like this we have to be careful not to hinder ourselves not too much while trying to them the maximum amount possible.So, how is this going to be done?Well, in individual cases we won't always be able to say that this absolutely has to be stopped because there will be a risk and cost.Anything we do in this arena so it is important for us to try to do this in a very careful fashion so we end up maximizing our effort while hindering the much as possible.My role on this, I think is to represent better in medicine and the animal aspects of the infectious diseases.If we consider that all of the bio terrorist agents accept small pox in some species of animals and they inaffect the companion animals that live in our home or domestic animals we deny pend on for food.It a huge task if we have to think about controlling these diseases in animals.And given that these infections can spread from animals to humans, if we want to control them in humans, we to them in animals also or we succeed.In there is a long list of foreign animal diseases that present severe threats to the agricultural economy and the agricultural economy broadly defined as the biggest segment of our economy.Whether those are accidentally introduced there is a better diagnostic vaccines or counter measures to protect our food supply.If we consider the recent emerging diseases, some recent eem mer diseases, madz cow disease emerged in England.West Nile virus which emerged here and influenza which was not soo ot particular and perhaps is now a threat for pandemic.And a virus that spread from fruit so swine and people in mal Malaysia and everyone of the recent exam -- examples they died more than in our and tracks attempt.And to control the infection is to stamp out the disease in animals.Given that, there is a small group of researchers that focus on the animal aspects of these diseases that are without a lot of funding so in this case race, it be run rapidly with the tortoise and the HA*ER and the man more diseases and more than the bioterrorism agents.It is imperative we be able to do that rapidly but safely and the safety is imperative also.So in our efforts to do good.We don't end up ultimately having a road man and doing harm what are trying to do.Thank you.

Thank you, Mr. Chairman.I would suggest that at the set here, that this to be one that is going to be sailing.We going to be tacking a lot and finding ourselves from time realizing we gotten too far in one direction and coming over to the million and moving over to the other side.That shouldn't be interpreted as being anything bad.We are feeling our way through a very time.I look at issue of biotechnology and where we are at today and I would agree with his points progress. was a great step forward in the warfare world when they went from swords and cross Beaus and not to be too to your enemy today, we we had an explosion of new tools and new capabilities to do things to mieb croabs or use microbes in ways we couldn't have done years ago.That acceleration of the will increase over time.That will, I think provide access to many additional parties to things unimaginable to organisms and we we have to account for that because we may put the account abilities of putting bad things, intended or unintended hands of people who may not be professionally or I should or deal with those outcomes.So I think one the things we are going to be doing today. like to licken it to surfing at MAUI.Where it is 60-foot waves you are dead.If you are on top of the wave, it is a hell of a ride.Our job is riding the wave to basically figure out how not to slow down progress in taking on the world of microbes but at same time not providing for someone to create great harm from those explosion of tools that we are creating today with our microbes.&%C1 &%F0

I think with the discussion and honesty and openness, we'll be able to do it.

seems to me the intelligence community, law enforcement and medical community share something in common with regard to this class of threat. While it might have been -- wriel you might have discovered them strange bed fellows, it seems to me that maximizing the interaction between these organizations, breaking down barriers and creating a fairly elegant interagency process is really the order of the day, something that's very difficult for a large government bureaucracy to do, so this is a real challenge. This threat is unique, obviously. We deal mostly with threats that come from offshore. The interesting thing about the biothreat is people who would perpetrate the threat could be insiders or they could come here. They don't need to bring that threat. They can manufacture that threat domestically. From a point of view of the inter-- Intel community, they have a responsibility top integrate domestic and force intelligence, there is a requirement to structure that community so it's better able to do that job, to transform that community, so that community's transformation as well as the ability to operate is important. That tran formation is like trying to change a tire on a car while it's moving. So clearly I think that the big challenge here is a challenge that is at the strategic level. It's a challenge of policy. It's also going to to be a challenge of interagency collaboration.

I'm here to represent the recombinant DNA advisory committee, a group that was formed in the late 1970s, in mart because of uncertainty of scientific direction for our country with regards to recombinant DNA. This group has functioned since the late 1970s and has served to guide both our scientific community and the public in terms of our direction. We run into bumps along the way. We've almost been disbanded at certain junctures but because of our focus, education, both of the scientific community and of the public, I believe that we've achieved and continue to achieve our goal, which is truly, to be certain that balance is reached, the recurrent theme regarding risk benefit. The risk being, in my mind, both to the individual and to our community of the inappropriate use of recombinant DNA technology and then a second risk, which is that in our enthusiasm, we might have, and I believe we have not dampened scientific productivity. We've accomplished this balance of risk benefit through the individual review of specific studies or protocol to look at each of these studies for their risk benefit. That's what this group is being asked to do, to look at various aspects of potential dual use, and we've done that through open public communication. Each of our meetings are open. They're not only open for we as rac members to sit and discuss but for those of the public to attend and ask questions which we actively answer and we exchange in discussion. We've also done that through a global perspective because both DNA, technology and bioterrorism are global issues. So the guidance that we've put forth as members of the rac is local guidance. It's meant to stretch throughout the world in order to diminish, probably not eliminate but in order to diminish the risk of bioterrorism. &%F0

He was mortified to realize that the British navy used his theories to track submarines. Here is the fellow who said I would never do anything that had practical applications. So in thinking about Dr. Zerhouni's charge to us, he put the dual use in an interesting framework. And that is scientific intent. Ill any the first to admit I'll have a hard time figuring out scientific intent. Any of us who work on pathogen sis. If we identify a gene associated with dorm man si or invasiveness, that means anyone working in pathogen ny sis works in a dual use environment. You would have to look into the soul of the person sitting next to me to figure out what the intent is. There are rules and regulations and international law that we have top maintain and adhere to in both a legal and moral sense. We really have to consider what the international law is in terms of the kinds of processes and developments that we work in. The notion of -- I think Diane really hit on it is risk assessment and threat assessment. What we have to do in coordination with the community, the public, the intell community, is to really figure out in a realistic way what the threat and risks are. Put aside all the hysteria and all the headline grabbing and all the this and the that but to take a very scientific approach, can we do a risk assessment, threat analysis of how dangerous and how will these things be used. We have to hold our self-s to the highest level and put aside some of the fears and hysteria. &%F0 &%C1 &%F0

I'd like to pick up on the theme of risk assessment because that's what we do, we try to assess whether a particular experiment dealing with recombinant DNA might lead to release of a recombinant organism into the environment or exposure of a worker to that organism. As it relates to the topic that this board is charged with, investigators who are working with, for example, a select agent, I think are clearly aware of the potential dual use aspect of that work and are thinning about that. There might be clear-cut guidance. &%C1 &%F0

A lot of times when this enters into an experiment you'll approve it or disprove it but sometimes you come up with something you didn't expect. Those are the kinds of things that we can't necessarily come up with any kind of rules for or against. That's where I think one of the important roles of this board and the ibc, is to increase investigators' awareness so people are thinking along those lines so if a result comes up that may have some implications for misuse that the person is aware of. The second comment is to reiterate what many of my colleagues have said. It's so important. The progress of science for the benefit of ban kind is so absolutely dependent on open communication of results that I would make the argument that in the vast majority of cases the good that would be gained from communicating results will far, far outweigh the potential for misuse. I think we really need to keep that in mind as we deliberate

I would simply start by acknowledging that I believe there to be credible threats that stem from the want ton or mischievous use of science. I think it's important for us to publicly acknowledge that it might also be important to recognize that perhaps the most likely threat will come from not those who set out to intend or deliberately cause harm, but from those who are simply mischievous or careless and might not have had that acknowledged intpt intent to start. It's important to recognize the problems we must grapple with are clearly rest son than the with the general public. They see this as an immensely important issue that must be dealt with and it behoofs to us acknowledge that concern and deal with it appropriately. Having said that, I would make three very simple further statements, some of which are somewhat repetitive of what's being said. First is the current scientific enterprise, although immensely power areful and potential is fragile. It as also precious. It is easy to damage, so I would first suggest that we follow parts of the hippo krait tick oath which suggests first that we do no harm to that precious enterprise. Secondly, I think it's too easy to be trapped in the examples and mind-sets of the past. We often harp on events or activities that have preceded us as guidance for what might be important to what we should do. Science is moving incredibly quickly. It's evolving in a way that we can only imagine and we can't quantify easily. I think it's important, therefore, that we strive to maintain a future base perspective on what constitute as potential risk, what is actually an important parcel of the good that comes from science. Finally, I would repeat what I think David Franz introduesed. That is the notion that we work in a seamless global community. As much as we would like to think we have some control over the scientific enterprise in this room or in this country, we really do not, and I think what we can best hope to do is simply influence the way in which our colleague in the community and the public think about these problems, sensitize them and cause them to deliberate over some of these issues that may not have come to their attention. I'm optimist thick this board can be helpful and do some good. Thank you

Knowing that I'm an attorney, you might be surprised that I harbor a certain degree of screptively -- skepticism to deal with the problems that we're addressing here today. I think this truly is a challenge without borders and one that challenges the ability of traditional notions of law and law enforcement to deal with the problem effectively. It is a profound risk and I believe that we must put our intellectual capital to its highest and best use, and in the interest of doing no harm to ensure that we develop new and improved methods of prophylaxis, detection identification and treatment to confront what I believe is an increasing risk and one that could result in disasterous consequences. I believe the work of this committee must be focused on ensuring that the forces of good can function in the freest and most effective manner with an eye towards ensuring that our adversaries are limited in their ability to export products, our ever expanding circle of know-how technology.

This board ask facing a tremendous task. This is the only answer. There's no discovery here. There's no invention. I just want to reflect on the issue and things that have been mentioned in one way or another. As John Dodd had said many years ago man is not an island. This is an international issue and will not be solved by one community or country. The issue is global. We all are concerned because the second dimension is innovation. What brought humanity to the year 2005 with all the tools that we have is the phenomenon of innovation, which is, by necessity, is widespread, is over the earth in the human community in the total globe. It is very, very dear, and it's a very important phenomenon and this has to be protected that innovation is not the property of a single body. It's a property of the total human effort everywhere in the world. Industry and particularly the -- is a major measure, important element of what is happening in this world. Consequently, it would be important to see that the point of view and the implications on a significant segment of our, again, the total human effort to find, discover and bring on solutions to some of the major health problems is part of our thinking. Thank you.

It's very difficult to be the 16th, 17th individual to be asked to comment on this. I agree with everything I've heard so far. I do think the threat is real. I do think that the answer to the threat is going to come from additional research and that it's very important, absolutely critical, as we go forward and deliberate these issues, that we preserve the ability for our research community to address that threat. We were asked by Dr. Zerhouni to consider the needs of the research community while preserving National Security. The research community serves the National Security, and I think very well. Preserving the scientific edge will be essential to stay ahead of not only man made threats but threats by the worst of all terrorists, mother are nature whether it's SARS or influenza. As a committee we have a real challenge to help the broad are public gain an awareness of both natural and man-made threats. I think science is under siege from a number of quarters. It's very important that the public understands what science can and cannot do. I think this committee can play a role in that. We live in a global community and nothing that we do here has a simple focus. We are willing to cheap that globe hall viewpoint. Thank you

One more in the line of speakers. You can also be the only physicist in the group of biologists and veterinarians but I would offer comments along the lines of the committee and what we have to do in paraphrasing what Dr. diser halloween nip and the -- diser halloween nip and the chairman said. If I could use a double negative, I would note it's not a natural state for our senior policy makers to not act and not act aggressively when faced with a perceived threat. The policy makers take very seriously what must seem to most of them has their most solemn responsibility. That is to protect Americans. They are inclined to act conservatively, very protectively, very restrictively. So if we're not successful in finding the ways that the chairman and Dr. Zerhouni suggested it, we will find the restrictions on the research which we want to avoid. I don't want to disagree with what anyone else has said along the lines of balance. I wonder if we can keep our minds open of what the concept of balance means. To me this means giving up one for another. We have to give have you freedoms to have stronger security or the other way around. I wonder if we can keep our minds open to the possibility, opportunities that both strengthen security and allow, encourage an aggressive plan. Thank you

I believe I was -- one of the reasons I was put on this committee and I accepted, for the past four years, the American society of microbiological and as the chief, we have been dealing directly with the issue of should we or should we not publish payers. I wanted to tell you what we have done to give you a set of facts of the kind of problem that we're facing. The American society for microbiological publishes 11 journals. The journal of virology is one of them. In the summer of 2002 I became the edittor and chief and was made aware very quickly of the public coon certains about anthrax, polio virous, during that summer the afm decided we wanted to let the public know that we take the problem of biosecurity very seriously even though we had zero guidance on how to proceed. So we instilled a culture of responsibility at all levels of asm. We had several calls trying to write a textbook in virology. Was also woirking on the conference calls with the various ASM journals. We came up with a two-part system with dealing with publication scrutiny. The other thing that we did was we wrote a position paper asking the national academy of sciences to give us some guidance on what to do. As a result, there was a meeting of all the edittors that published the scientific work in Washington, D.C. sponsored by the national academy to discuss this problem. There was also, then, the national academy put together the so-called think report, which gave us some guidance. But that took several years before that showed up. Basically, the system we used is simple. There are two parts to it. The first thing is that every paper that goes through the journal of virology is reviewed by 200 members of our edittoral board or add okay board. There's a checkoff that says do you think this has led to misuse. If that box is checked, the paper comes to me and the chairman and we discuss what we're going to do with that. The second thing is that the select agent list is well known. The publication staff of all ASM journals flag the papers. Depending on which gurn hall that they're in, every one is looked at by the edittor and chief. If there is something that there's a question about, we discuss it with the publication board chairman. Just to give you a little bit of data here. In the four years that I've been involved in doing this, the journal of virology has looked at 15,000 manuscripts. About half have been published and accepted. The other rejected for scientific purposes. I would suspect those that were rejected were published on the web, you need to understand the bottle has many holes and we are only one cork in the system. The select manuscripts that we published, that we looked at. There were 651 select man knew Scripps. We reviewed 654. 168 were from nonU.S. authors. The ASM journals total 111. There are 1,000 papers on select ones that were accepted. Of the journal of vir polling papers that we looked at we didn't identify any one that had a potential for misuse that was one or two that came up from one of the reviewers, asked questions about vir rue lent studies. When you stud dispi pathogen ny sis, you are looking at the gene because when you knock it out you lose pathogen sis. There were two or three paper thats that were flagged or were subsequently approved. The bottom line is that this concept of dual use, at least at my level, is a real miss gnomer. It's not a bifair ry process. It's not black or white. There are nuances of what the science will be used for. We have a very difficult time in deciding where the balance is going to be. The problem is that there's a disconnect between the information that's in the paper and the use of that information. We're pretty good now at deciding whether the information is scientifically accurate, can be reproduced is good science but we can't tell what is going to be in the hearts and minds of the individuals who may want to use that. So I thought I would just and here by saying that this board really has a job in front of it in order to look at the real practical problems of the fact that we publish thousands of papers every year that deal with this. Not only in the biological sciences but areas of mechanics and physics that could have the potential for problems. So we have to get, I think, a spirit of responsibility at the level of the individual signs d-sciences and in the individual organizations so we don't stifle the scientific enterprise. It's a fragile enterprise. It's the reason why we're so powerful. We can't let this enterprise go south. On the other hand, we really understand there's a serious problem in -- that's facing all of us. So we have to get the general public to understand that we're trying. We have to have some rules and guidance that lives up to this. I look forward to participating in this process.

I have a somewhat different perspective to offer coming from my 30-year career on occupational transmission of infectious disease. For me it was a very sobering perspective that four of the five deaths of the anthrax of mail terrorism in 2001 were due to exposures at work. Much more likely scenarios than bioterrorism, as we know it, are scenarios relating to safe operations of the high containment laboratories where we are doing the research. Accident, operational, mechanical or maintenance failures, sabotage or theft of research. Concern about how we work in biological laboratories is just as important to National Security as concerns about what work we are doing in those laboratories. The perspective I would like to offer to my colleagues is that we not overlook the ob vieous in our analyses. We can accomplish a lot of new National Security by expanding the existing by developing additional principles and practices of safe science in doing good science.

I'd like to offer a parable from which I derived several morales. In the interest of brevity I'll present two. I recently led a delegation of university administratetors and faculty from the people of cine na. it was research agreements, exchanges of scientists from American universities to other universities and vice veer sai. I was struck by the fact that I've been visiting various countries in Asia for several decades. The openness of the Chinese scientist to the prospect of collaboration was unprecedented in my experience. Prior to going on the trip, I had read an issue of nature that was devoted to avieian influen disa, a sobering analysis of that epidemic if it's not checked. Among the contributors was a member of the board. So two morals that I derived. One to establish a balance between the openness, the classic traditions of the academy to protect National Security which I thought Dr. Franz stated very succinctly and was echoed by many other members of this board. Another moral that I didn't hear referred to is that balance is a necessary but not sufficient condition. Communication of the balance must be conveyed with adequate nuance, yet very clearly. I know 100% of the journalists are present are sensitive and can indeed do that, but the prospect of talk radio, talk tv, blog sites, the one extreme of we must not inhibit any communication or any scientific discussion much the other that we must be highly restrictive and highly protective, the likelihood that they will be distorted is enormous. Given the fact that Dr. Casper outlined five task forces or committees that will be formed, two of them could potentially deal with this issue. We might benefit in those committee meetings from having people who are experts in communications talk with us about not only what conclusions we arrive at based on our considered judgment but how we communicate that to the world at large.

We're going to interrupt these introductory remarks before we move to the ex-officio members. I will go on to ask them to speak, but we're fortunate enough to have Dr. van ky ya with us, the special assistant to the president and he was director for biodefense in health at the White House homeland security council and played a significant role in U.S. government policies an biosecurity, biosurveillance public health and national defense strategy. We're happy to have you here with us today to give us your thoughts.

Thank you, Dr. Casper. Thank you all for indulging me in interrupting the presentation. I didn't interrupt the real members, just the ex-officios who I work with every day. I do appreciate the opportunity to give you a little bit of background of what led to this meeting today. There is a parable there that is worth keeping in mind, which I'll get to at the end, that resides in the store vie of how the NSABB was established. From the start of the discussion of biosecurity in 2003 there was significant issue at all levels of government, particularly at the White House. I can tell you that in the summer of 2003, in light of the news that was coming out of the department of energy and follow-up to Dr. grimmer's work, there was an increasing sense of anxst around government that would eventually bring to us a point where the technology to do big things would reside around the world. Right around that time the homeland security council, which is an analog of the National Security council convened a group of federal partners to talk about this issue. This just so happened, coincidentally, that the national research council was about to publish its report on dual use technology in life sciences research ?implt' never seen a professional community so far ahead of the curve. They had already begun the process of drafting what the professional community's opinion and perspective and recommendations would be around this issue. It took two years to get to this set of recommendations. I can tell you were it not for the recommendations arriving at the time that they did, as well as briefings at the White House with cabinet secretaries by the nrc by doctors Albert, firchg and at last, who know was the government would have come up with. We have a lot of smart people in government and the administration, but left to their own devices they will come up to a solution one way or another. We all benefit when that solution is informed to the maximum extent possible by the technical considerations that came out of that NRC report. When you map it against the policy by secretary Thompson in spring 2004, you'll find there are parallels between the two documents. Secretary Thompson, I can tell you, put for the a document that proceed very rapidly, led in coordination with the office of science and technology policy and the homeland security council under the leadership of general Gordon whom you see before you. Those recommendations were adopted by the interagency. We had the announcement. The most visible representation of the biosecurity policy which is bigger than the NSABB, is the NSABB. While I think many people breathe a sigh of relief that the U.S. government did not come out with an overreaching dray conian approach to biosecurity, no one should go to sleep thinning the U.S. government has stopped thinking about this. They're awaiting the reconvening of this body top answer questions that come up every day around biosecurity. I did not get milk in my coffee today because of considerations that have been raised in the past couple of weeks. It's a joke. I did get mill income my coffee. Clearly, we will continue facing issues. They're in the going away. We will have these discussion. Let me just leave you with three issues that I think you should keep in mind. First of all, the body that you see above you is comprised of individuals from around the community. It as also comprised of ex-officio members. We view this as reaching well outside and outside the bounds of the U.S. government. This is not just an NIH. The secretary of health and human services has ultimate authority but this group will be advising the conduct, funding, support of life sciences research across the U.S. government. Every cabinet secretary is going to be listening to what you're going to say. They will take the recommendations seriously. Please keep that in mind. Please keep in mind you're not just dealing with the research supported by hhs. The parable that I mentioned in the beginning of this discussion about how we should all be thankful that the NRC came forward with this report, continues to aplie. to the extent you can be forward thinking rather than establishing approaches that don't move the ball forward, don't bring the sciewmpt and science community -- security and science community more together, you should be ready. You will be aware of the concerns before they make their way to the "Washington Post" or the New York times. This group is aware of the issues we'll see a year from now. I'm glad to see this embedded genome is here. What the government does, what any government does, what any professional organization does, what any company does is irrelevant if the individual scientist does not have at his or her core a sense of what the right thing to do is. I know there's some debate on whether we need codes of conduct. I can tell you that coming out of the medical community that it rolls off one's tongue that a physician will do no harm. I've gone through very good scientific institutions. I can't recall explicit training in biosecurity considerations, explicit training in ethical situations. It's not to say that every single person I work with do not conduct their efforts in Annette thick clip and responsible manner, it's just that it was not part of the curriculum. Before we dismiss the idea of a code of conduct, we first need to have a code. Whether it's done in collaboration with others, we need to have something, a set of principles. Then we need to infuse the educational systems around not only the government but around the world so that every person coming out of training understands that this is the core tenant of the work that they are doing. And, this should be implicitly part of every bit of work that's done at the bench side. A PI should be communicating this to his dissigh peels. So I view the single point of failure as being the individual scientist. I don't mean that in a bad way but in a good way. To the extent we can do these other things but at the same time ensure that we build this set of rib si peels principles and promulgate it, we will benefit. Thank you. Enjoy the meeting.

Thank you very much. I think we'll continue now with the ex-officio members.

Each of us today have been directly or indirectly touched by a product of biotechnology. They're pervasive. They will become more so during this century of the genome as we sequence genomes for agricultural commodities. We're doing it on a daily basises for, for pathogens. As we do this there will be more and more opportunities to use and perhaps misuse these products, so the challenge is great but one thing I would like to say to this committee is that challenge has been there before. If we look at the rac committee, if we look at the way the biotechnology based food enter the market. Look at the department of agriculture, the oversight of the use of products we see great successes. I think we can also expect that the results will help this government and provide us great successes in both doing two things. One is meeting our institution hall responsibility to take advantage of this genomic information, to promote science and also at the same time not to provide weapons. One of the things that -- my greatest concern is the same thing that he talked about is the individual investigator. This is the critical point in all of this. We know that if we raised children, behavior modification is probably the greatest challenge in the world. We're really looking to you for policy, for ways to behave to change the behavior. I know there are two things that sometimes seem to get in each other's way. One is accountability. The other is creativity. We don't want to slow down the creativity of American scientists as we take on this challenge, so I think it's a great challenge that this committee has. I think there are many things that we will be able to use. I already had many inquiries from different groups about how we're managing this dual use system and I will tell you that we are waiting to hear from this committee. Your recommendations both on policy and activities that we need to take on. So thank you.

As I mentioned, the national science foundation has, as its big picture mission, seeing to the welfare of scientific research and education in the United States. So one of the things we need to do is constantly scan the horizon for gaps in the science that underlie our ability to deal with the natural or unnatural threats that are posed both to humans and agriculture and the environment. One of the areas that we think is very important that hasn't had much attention, so far, is the e cooling behind what microbes are doing in nature as well as human beings. I appreciate the doctor's mention of microbial. It has a great deal to do with new diseases in both plants, animals and humans. That's an area that we need to be sure is encouraged and not inhibited by anything that goes on here. The other element of our mission has to do with education and looking at the future of science. A lot of scientists come from undergraduate institutions and from undergraduate education that incorporates the ability to do research. One of the things -- the scary thing that occasionally crops up when we zeroals from undergraduate institutions about projects that undergraduates are doing, the ranges are very sophisticated on things that can be done with relatively small amounts of funding and with very little infrastructure. We want to be sure we don't do anything to discourage the ability of undergraduate institutions to promote the integration of research into their activity, small nonresearch universities have a huge role in training the next generation of the public as well as the scientists of the future. When we're considering the issues of balance, we want to be sure to take into account the possibilities for Ms. Understand -- miss understanding or science and education.

I'd lick to point out some of the areas of synergy with things we do at NASA, both areas where we can provide some expertise and more importantly that we can gain from what the board is doing. The most obvious one is the area of plan they tear ry protection. We're thinking about both mitigating the forward contamination of other planets as we go to explore but also thinking about the backward contamination of the earth as we have return missions that we're expecting to have up ahead. So we spend a lot of time working on what kinds of environments, organizations might be able to survive in but also how to detect them and how to make sure that they don't contaminate areas that we don't want contaminated. Along with that is we have our crew Mel beres working in closed environments with very little chance of egress. So we need to be very sure that we don't bring organisms that are questionable into that environment. So we have a large effort of monitoring and control. Some of the technologies that have spun off that are state of the art for anthrax detection. Even though that's not what we intended them for. Another area is astro biological where it's the study of search for life in the iewfs and thinking -- in the universe. Also as part of that, our researchers are looking for life in the most extreme environment on earth. There's also the potential there to discover unique kinds of organisms which could have biosecurity problems and how we handle those. Another area is on disease alteration and space environment. There's a unique aspect such as microgravity and kinds of radiation that we don't have here on earth. What we found is there are alterations, especially in microbes in those environments. The increases in vir riewp lens and decreases in the human immune response which could have disasterous results. Finally, I mentioned the environmental monitoring and control, especially on places like the international space station, but the one thing we could bring not committee several have mentioned this is definitely a global issue, not a federal issue, something we need to work with our international partners on this where we can bring our experience from the international space station and the 16 international partners that we work with there on issues that are similar to this.

The availability of the tools and skill set for use, biowar fare and bioterrorism, is huge.

The intention of our add veer sair ry is malignant. The acquisition of useful information is truly daunting for us. Activities in which we would have and will continue to have an interest are easily to hide, and there are a lot of places to hide them. That said, I'm going to take an optimistic case that this group, this advisory board will define the appropriate policy. However, if we are to maintain openness and facing information in the public domain, then the science and technology in which we engage must be preeminent. If we fall behind, we'll have a very, very steep price to pay. We don't expect the struggle to be either easy or short. We look to the eminent individuals who are serving on this committee for a balance of opinions.

I'd just like to echo the historical perspective on my colleague when he was talking about in the summer of 2003 when all of this really began in the White House and generalgoer gone and the president's science adviser they offered options to the president for consideration of how do we deal with this increase in security risk posed by dual use life science research. When we gathered the federal partners and began to examine the deliberations, it really is good to understand that there were a wide variety of options that were offered to the leadership. Everything from do absolutely nothing to the opposite end of the spectrum where there were options that were extremely harsh, dr lasmd conian that would have brought science to a crashing halt. We recognize that. The president chose a balanced option that created this body. So it was with that deliberate measure that bringing together the variety of subject matter experts and disciplines that are represented on this body, we are very, very eagerly waiting the deliberations, the advice, the recommendations, the best practices that we have not only to offer to hour federal government agencies but in the way of best practices that could be extended to the private sector as well as international areas so we can address this dual use life science and biotechnology. &%F0

I work for the federal government so do all of my colleagues. We spend a lot of time in meetings on advisory boards. There comes a point during halfway through session like this that we start thinking, gee, everything has been said, not everyone has said it yet. That is so not the case here. I've been you aked. Literally everHawn has made a genuine and unique contribution to the discussion. I'm going to see if I can keep that up mildly. My thought is in the history of science and National Security's relationship most of the lessons that we have in the literature come from our work with nuclear materials. One of the things that controls that discussion is a limited amount of comfort that we historically had with the fact that these are either difficult things to make or difficult things to get. The problem with the life sciences is that we've created a twisted metaphor of the philosopher. We have made these things exordinarily exakable. The tools accessible. My colleague said that not only are these things already the tools to do life science research already in colleges, but I wouldn't be surprised if it's not too many years before we see this sophisticated ability in high school laboratories. Given that, the question then becomes is it only the intentional adversary that we have to think about. As my friend said a moment ago, no, it's probably not. We have to worry about the mischievousness. We have to worry about those who are simply curious and those who are not old enough who have quite developed the super functioning ego. Given that, we have a couple of lessons. Are we in the same place as computer science was 20 years ago with hackers. Computers have son us have shown us that doing something bad does not require malice. Given that, I'm in the sure where we stand with regard to the need of a code of conduct, but we clearly have to look at what the importance of influences educational policy and public opinion on the issue and explore questions that have to do with how we teach a sense of responsibility hopefully quite early on in the educational process and export whatever curriculum or whatever ideas we have developed in this country as broadly as possible

I'm mostly impressed with some of the thoughts that have been expressed this morning. I think mine may be just a little bit different. VH a.'s research program's primary goal is to benefit and enhance the veterans and the nation itself. Our program of research encompasses everything from very basic research, from immune following, infectious disease, on and on to clinical trials, translational research and health systems research. We have over 120 facilities that conduct some type of research. Many of them are affiliated with an academic institution. Our investigators are as varied as our research is. They work some of the -- some have academic appointments and work part time for both the VA and the university. We have a number of challenges, one of which is that recognizing that our resploich is to benefit the veterans and his or her health, the challenges that I also recognize, that our good intentions may end up with research that we could classify as dual use research. We, therefore, have to give hour investigators and hour administrators tools to recognize what dual research is and how to minimize it while still continuing with research that we were need to do for our -- to meet our objective. The other challenge in this area is that we need to be able to change the area in which we're doing research based on the needs and maybe I should say misdeeds of others, that we should be able to and I think we can respond rapidly to new threats to our veteran's health and our nation's health. The other real challenge is in security of our facilities, our data, our resources in trying to balance that so that we don't decrease our ability to collaborate with others outside of the VA, to have access to all the resources that they need and to sort of control the access to our facility. The biggest challenge of all, and I think this is where this advisory panel will be the most help to us is trying to identify where we need to set our policies and our standards related to these issues and with the thought that we don't want to make this harder for people to conduct the research that is so important to our nation, but yet that we really want to make sure there's no misuse or that dual use of research. Once we sort of get an idea where we want to go with our policy and guidance, the other important issue will be developing the educational programs to go along with that. Again, that will address some of the ethical standards and identify ways to address dual use and change gears fast and refocus, research in areas that would be needed because of some very negative things that can happen in our environment from other people.

First, I'd just like to say the didn't of justice -- the department of justice and FBI are pleased to be part of this endeavor. We are looking forward to this body in helping to clearly define those terms as we move forward so when we discuss biosecurity we're starting from the same baseline. In addition, as an advisory board as opposed to a regulatory board we see a critical role for this body in increasing the sensitivity and awareness of these issues really across the scientific, law enforcement and intelligence community. Having such a broad rep sensation -- representation will be an as set. We're looking forward to being part of that process. I think this board also provides an opportunity to increase the partnership between the scientific community and security community, National Security and homeland security communities. I parallel that to some of the work we've been doing between law enforcement and public help between the FBI and CDC and law enforcement across the state, local and federal levels. Obviously, we rely on the public health community to identify suspicious outbreak or a case that may raise the index of suspicion and trigger a notification where we can jointly investigate that case to determine if it has some criminal nature to it. The scientific community would be the first to recognize sus spishious activity and rely on them to monitor that activity and provide a mechanism to raise that up. I think that also ties into the culture of responsibility that doctors diser halloween nip and r -- Zerhouni and rajav mentioned. I think this body will be in a position to address a broad range of issues related to biosecurity and provide much needed guidance. Hopefully we won't drown in the process

You caught me day dreaming there. I thought you were going down there, but day dreaming on the points being made. Excellent discussion

I'll try not to take that personally

I realized as I was saying it, what was coming out. I guess I won't wax and wane philosophically here. There's been a lot of germane discussion along those lines. As the representative from the department of commerce, I explained earlier, that my role is to represent the scientific elements of DOC, which is noaa and NIs T. I think the intensity of its representation is not has manifest has it could be by bringing in a representative from NOAA. I'm reminded of what red tide is doing to the New England fiduciaries right -- fisheries right now. Although most of us have alternative places to get clamps and oisters, there's a big sector of the economy that's paying a dear price on what nature has inflekted on us but wouldn't be difficult for someone to dream up a more deliberate man-made scheme. NIST is very familiar with dual use technologies. We derive most of our work statements from other agency missions or the facilitation of science, scientific discovery and technology into the marketplace. Sometimes we work more directly with commerce, with industrial partnerships, but other agencies still represent the majority of the kinds of work that goes on at NIST. It' like -- id e like to give two examples. Perhaps the train of thought will be stimulating in some way and the other one which is more directly related. The first one more than three decades ago people were asking the question of how well we know time. Well, gee wiz, we had that down to 10 or 12 des mal places, what more do we have to do. Those people who were things about -- thinking about satellite communication had to bump that out. So NIST invested a fair amount of capital into striving for that. We take for granted satellite communications, direct TV, et cetera, but that is critically dependent on how well we can synchronize signals. The effort to do that led to the discovery of a new state of matter. That has further still mewlated thinking about the last Artie fact, the kill low gra. there's still appeals of material setting in France which gets taken out every 30 or 40 years which weighs one kilogram. That's not good enough anymore. It's an effort to use our research to find a nonartifact measure of weight. About five years ago we were at this story number which, which I'll end with, we were asked by a part of the department of agriculture to help with the measurement of genetically modified grains in a mixture of grain. We were challenged by the European community to find basically one Kernel of corn in a boat load of corn which came from a modified corn plant. Half of the corn grown in this country is genetically modified. We started a project with the department of agriculture to benchmark real time PCR methodology for finding that one kernel in that boat load of corn. There have been advanced reference materials and technologies helping the world make those measurements. At some point this is probably one of the leading technologies that will be used to discover microbial insult in a rich microbial environment. So those are are the kinds of things that NIST gets involved. We need other agency problems to define the problem and help us with the measurement issues in which the quantification becomes an issue of public health, of health in general, so thank you for the time, Mr. chairman.

Thank you. I have a knew brief comments to make on behalf of HHS. It's clear this is an extremely important board as the advice is important to us, the whole federal government and the government. We need to have new measures. We have to have new drugs, vaccines, diagnostics for public health threats of various types. We are concerned about balance. At the same time we want to make sure that the National Security is protected. I'd like to say a few words perhaps about the urgency of this. We have been waiting for this group to get together and to however advice. We need to get the advice. There's, I think, rem men dust pressure that will be placed on the working group to provide the advice. There's a challenge that was mentioned in terms of how to get the advice and recommendations, good practices, et cetera, implemented, how to get them to the right international bodies, for example, how to do the right thing domestically. I think a challenge for the board, in particular, is the fact that this is not a deknow vow situation. There's a great deal happening as expressed by many of the experts related to, for example, the communications issue. We know many are actively engaged in codes of conduct. WHo is involved. There will be a real shall you drawing on what is happening internationally, integrating this into the work of the working group and bringing that back here to the board as a whole. We're fortunate to have the experts on this group that we do and people who are directly involved in these, both domestically and internationally, so I think there are these major challenges, the urgency of getting this done and then the process issues in terms of work the various groups coming up with recommendations and getting these disseminated and adopted. Thank you.

Thank you. One of the challenges I have at the current position for chime' apointed is trying to protect hour men and women in uniform against chemical, biological and nuclear threats so they can protect us and our allies. I spend a good part of my days, nights and evenings, trying to come up with ways in which we can protect the men and women in union form whether with chemical suits cor vaccines -- or vaccines for an level anthrax. There are a lot more good people in the world than bad people. Unfortunately, there are bad people who want to harm us. As hour legal representative on the advisory board indicated, we cannot pass enough rules and laws to stop the bad guys, but we can do things to slow them down a little bit. One of the things we observed, people rob banks because that's where the money is. Those that want to do harm against -- using the bioknowledge are going to look where that knowledge; in the science, technology base and companies. There are things we can do to slow the spread of that information down. That does not mean that we lock up the knowledge. That means we look the limited distribution. For example, there will be some information that's sensitive enough that we do not want to publish it in the total open literature. As indicate, a lot of this responsibility comes down to the principal investigator level. We need to create an awareness from them on some of the issues that we need to be aware of that people could use in a harmful way. That information, plus this advisory board can help guide us in how we handle certain amounts of information that are sensitive that can really cause us harm. Thank you.

I'd like to just make a -- give an example of a different kind of short of National Security risk from some that have already been mentioned as we've gone around the table. There was an interesting sort of thought piece recently published by former cia director and the former secretary of state in which they were talking about the opportunities to get freedom in the United States from dependent and foreign oil. Their argument was based on basically two things, one, improving materials so that we can make cars much lighter, they use much less gasoline and also increasing the amount of alternative fuels that we developed. In the end of their argument -- I mean, they claim that the calculations that they and their colleagues have done, we have it within our capability to develop an automobile that would effectively go 1,000 miles on one gallon of gasoline, and if we can do that we wouldn't need foreign oil at all. One of the interesting corollaries to that is that if you take the example of converting biomass, specifically sell you lows to ethanol, we certainly do that already. It's done around the world, but it's still a fairly expensive process involving heat, involving chemical treatments and involving biological processes. Given the diverse almost seems like unlimited capability of microbes, it seems well within our grasp to design or reengineer microbes or communities of microbes that could do that entire process very cost effectively and very efficiently. One of the interesting, I think, dilemmas that we're faced with as a committee but scientific community is how far we go in the interest of National Security on both ends in terms of limiting or not limiting research or to protect us from harm that could be done but also to enable us to receive the benefits from that research, in things ranging from public health but also things as different as energy utilization and relyians an on foreign sources of oil

I'm here to share the speer spectsive -- perspectives on the National Institues of Health. Let me state from the onset that the NIH is committed to the implementation of the new biosecurity initiatives. We recognize the potential misuse of the technologist and information that derive from life sciences research. Yet, we do neat to put this in the appropriate context to be sure that any measure is implemented or done in a balance that's been discussed by nearly everyone who have spoken. Rerealize it's not possible to stop bad things happening by bad people. The goal should be to minimize the risks. We do support the principle and the practice of a code of crone duct in the scientific community, recognizing we need to work together from the ground up to embark upon this in the right way and that we need to facilitate and develop a culture of responsibility at all levels of scientific endeavors. Certainly from the perspective of the NIH it's important to reiterate the caveat on the need to weigh risks versus benefits. Consider the National Institues of Health to improve the human health. It's clear to every yon who works in life sciences research interest's a -- there's a direct correlation between this process and the payoff of diagnosis, prevention and treatment of disease. We certainly support that this doesn't pertain to humans alone but extends to the agricultural sector, to animals, animal health, veterinary health, crop animals and plants for the -- for which we depend on for sustenance. This is of critical importance to the economy of the United States. So, any and all strategies that are put forward, any and all processes need to be considered in the context of the potential risk for impeding the free flow of scientific information and the advance of the very science that could bring us solution from diagnosis, prevention and street of the risks we can take whoever the table and to encourage that science is a global endeavor, recognizing that discussions need to be engaged at the international level. I think it's appropriate to close my comments just in recognizing the efforts of our colleagues and office of biotechnology and thank Dr. Patterson and her colleagues for the daunting task of setting the stage and assembling the individuals in the timeline they had and putting it in such a cogent way land to thank all of the board members who assumed a responsibility in take up the task as well as the participants. We certainly appreciate the NIH and the niaid to pursue the key agents of bioterror but we're doing this in a way that's placed in the context of e mer just infectious diseases, so any benefits would have benefits and payoffs to infectious diseases overall. So it will have a major impact on our processes and we look forward to working with you and to seeking your guidance as we move forward together.

Thank you for this opportunity to speak. As we kind of approach how looking ahead to the next year, they're approaching the last 100 years. As we look backward, you look at a variety of challenges and solutions. The challenge deals with the issue of dual public research. I'm confident in looking at the board that that solution, although difficult to discern at this point in time, will become more clear has we continue to work in this endeavor. As I mentioned previously earlier, FDA's mission involves ensuring the safety and security of our food, biological agents and medical devices. An important facet of our count tr terrorism mission also deals with the availability of safe medical measures including drugs, vaccines as well as medical devices and other diagnostic tools. This mission with the themes of safety, security and availability obviously cannot be acleaved without a vigorous and rigorous research program. It's conducted at academic centers, government centers and private industry. Often this research leads down that winding path term dual purpose research. Dual purpose research is not a bine fair ry concept. It's not yes or no. The question in front of this board is where do we draw the line and what do we do about it once the line is drawn. So I look forward to serves as an ex-officio member, look forward to looking at the advice, guidance and leadership regarding the dual use research that comes from this board. This is a difficult undertaking. And I'm sure as much of the audience and board members did gasped a little when we saw the charge. It's a little overwhelming. Obviously, looking at how communication has expanded we're dealing no longer with just the printed word but the electronic word. We're also dealing with the internationalism inherent. In conclusion, I would like to tell the board, the term ex-officio often can be a misgnomer for people who are not familiar. Certainly there are gaps, if there are gaps in information, subject matter or other expertise, we certainly saw the qualifications of the board. If something comes up in the working groups, certainly utilize the agency's presence. Thank you again for this opportunity. I look forward to working with you all

Thank you. The vision is to -- is a healthy people. Since disease knows no borders, this applies globally. We have in the national center for infectious diseases great experience in public prepareness and response. This applies not only to natural infections but also those that may be the result of a bioterrorism act. We have a focus of research that is in the applied areas. That means we are particularly interested in detecting through better diagnostics infectious diseases. We are also very involved in characterization of infectious diseases. This has been a long history of us. We are very interested in high disen fying forces -- identifying natural infections. That can be applied in the agents of bioTrix. We -- bioTrix bioterrorism. We're interested in microbiological, from our long history of looking at infectious diseases. We're interested in health, the e cooling, transmission of disease through vectors and through animals, so we find these areas to be very important and must continue. Our focus is to protect the public's health. We use various mechanisms to deliver our message, also in the form of MMWR's and other messages that go to the public, healthcare and associated communities. So we're very interested in the board's activities. We want to ensure that there is a balance that includes proteching the health of the public at the same time protecting information that may do the public harm. Thank you. &%F0

Thank you. I think it's very obvious to everybody here that the board has an extremely complex and challenging problem, a really daunting challenge. I just want to maybe emphasize a point that was offered up very early in these discussions and perhaps an opportunity to help us come to some solutions. That's really, I think, defined by perhaps our cultures, our disciplines that we come from here, our multidisciplinary approach and the operational backgrounds that are represented on the board and the ex-officio members and the active participation I know the board will get as we move forward. That culture represents culture from the life sciences, intelligence community, law enforcement community, medicine, public health and an operational first responder community for all the defined. These communities have got and are coming together like never before. It doesn't mean in we, from hour individual perspectives and framework are seeing cultures, we don't give up hour cultures. That's our strength, but we have the opportunity to include some of our different cultures so we can make sure, maintain the scientific engine and keep the race up and also be able to instill the appropriate security of culture necessary to make sure that we don't give our adversaries information that could be used to, in fact, attack our vulnerabilities. Within the department of homeland security we find our self-most often at the nexus of all these different cultures, whether it's working with the medical health community, law enforcement and the operational first user communities. So I think this -- the culture that we bring to the table, the partnerships represented at the federal level, represented by Alt ex-officio members here but we also have to bring in the state, local officials, academia, private sector. This is our opportunity to address these problems and find -- that's part of the solution to think through these tough issues and help us with a response. Within the department of homeland security, just briefly, some of your biocounter terrorism they span from attack warnings surveillance, to working very closely with USDA. To having programs that will help us better understand the threat how our adversaries might use a pathogen as a weapon to attack us and programs so we can work with the lead federal law enforcement agency to identify the perpetrator if we are attacked. So we are very ache just to work very -- ache just to work closely with the NSABB. I look forward to working personally with everybody on the board

Mr. chairman I find myself in the position of being the last of 38 speakers this morning. Not only has my thunder been stolen but the clouds are gone and the sun is shining. I'll try to spend a quick moment reinforcing a thought from the department of the interior. Being a department of interior representative my eyes are on the American system. It's not hard to image Jane scenario where some foreign organize gan nix has been released into America's natural system that would wreak of a Vic and create catastrophic Cascade effects and reduce the resillian -- resiliency of the ecosystem. This would have some very significant economic, political and social consequences. So my point here is that a disease would not necessarily have to have a direct impact on the human population but could be restricted to the animal populations themselves and yet have direct impact op the human populations. So what are we in the federal government doing about it? E are seeking to develop integrated and coordinated network of disease surveillance across the human, animal community. We're testing a rapid response program to reduce the e her gens of disease, be it in human populations, captive animals or in wildlife. Lastly, we're seeking to establish and utilize a system of information exchange across these components of the surveillance land response networks. One of the overarching themes, the need to think broadly, across multiple scales. Also, the need to break down organizational barriers among the different components of the different systems I just described to you. This need to break down barriers, increase communication and improve information flow has been a tension with some of the things we've discussed today. Looking forward to find the right way to create the communications and to ensure that we do this thing right on behalf of the American people. Thank you

Thank you and thank you everyone for your comments. It's clear to me that there's a lot of wisdom and knowledge in this group. And also there's not Hess tent si to share your ideas. I think we'll have vigorous and open discussions about these very important issues. Dr. Amy Patterson, the director of the NIH office of bioterrorism has a few comments to make.

thank you. I was asked to clarify an issue that came up during the break, from the board members and from the audience. He'll be brief but I want to begin by echoing the comment that many of the speakers have made that it's a precious research one Florida that -- one that the agencies are charged with. That argument is predicated ot only on scientific talent but also on public trust. Public trust itself is a precious resource, one that is earned or merited, enhanced by public awareness or understanding. It's the public that has provided the support that the board will be looking at. The public will bear the consequences of the federal policies that e original as a result of the board's deliberations. For this reason we want to be exceptionally clear that the board will meet publicly in accord dance with the federal advisory committee act. On the rare location that it arises that we need to close the board meeting, that would only be done in acord dance with the aplik cable laws -- applicable laws and regulations. Thank you. &%F0

Thank you. Well, this concludes or agenda for the morning. We're going to take a lunch break now. All the board members, including the ex-officios are asked to meet in the car ti a. Cart tier salon. We'll hear by the rules we must abide by we'll reconvene promptly at 1:00 p.m. for the afternoon session. Thank you. &%F0 &%C1 &%F0

Please stand by for session I. &%F0

Welcome back. Hope everybody enjoyed their lunch, as Dr. Casper mentioned, my name is Paul keim, I will be chairing the session this afternoon. We're privileged to have a variety of experts to provide an introduction to top that the NSABB has been charged to address. The objective is is to address items relevant to the criteria for identifying dual use research and research results. Please keep inmind the board members will have an opportunity to address the speakers during the panel discussion following the last talk, so hold your questions. There's also time reserved for public comment at the end of today's lecture. Our first speaker today is an NSABB board member, Dr. Arturo Casadevall from Albert Einstein college of medicine who will introduce the issues relevant to dual use research.

Thank you. The committee invited me. I thought I would talk about is there a line in the sand, and I begin by showing you my car. And I remind you that dual use technology and would argue that the civilian passenger sedan is the most effective weapon of war in Iraq, and it's certainly you seat loaded with explosives. It is easier to make any car bomb than to make in a weapon form. If you look at the dictionary a weapon is something -- it's a club, a knife, a gun, used had to injure, defeat, or destroy in contending against one another. As humans, one of the things that history teaches us is that we have used many agents as weapons. We have weapons that are kinetic, radiological, informatic. Some of the other weapon types are limited by physical laws. Then we are confronted with biological weapons, and here we have the problem, that the variety is enormous. The efficacy of the weapons is dependent upon both the microbe and the host, and many of the relationships are not understood. So if you begin to think about the line in the sand, you're confronted with a great gulf of absence of knowledge. You can look at visions of weapons as Mike croabs. There are two ways to look at them. One of them is tunnel vision, the other one is tunnel myopic vision. The tunnel vision is clear in that it sees things either weapon or not weapon.

when you begin to think that way, that has been used to generate select agents. The other vision, if you are myopic like me, if I take my glasses off, everything becomes blurry. You have a tunnel myopic vision in which things are some bad, not so bad, and then bad. The question is, where does this go? I give you an example. You can buy this at my super market. So I would ask you, is this dangerous? Is at weapon? You would probably -- I would agree with you that it is not too dangerous. However, for this individual with aids, they got a disease, and you say, well, that person is getting compromised, but already think about it. In order to define it you have to think about the host. You can't do it from the micobial. You look at the fact that normal women can get it, and here's a recent case reported about a baker who ended up having a piece of lung taken out because he had a nodule similar to what appeared to be tuberculosis. So the point is, yes, you're dealing with an organism with low intrinsic potential to be a weapon, but depending on the host this could injure. When it comes toin jury, you could argue that disease may not necessarily, from the individual's point of view, may not be different, whether you're very sick from this or from an agent on the select agent's list. You can think the same way with yogurt. Is there a weapon here? Depending on the host, it can cause severe disease. One of the -- so one of the -- a few years ago I began thinking about this and this assignment. In reading on it, I began to wonder how this agent ended up, and I will adhere that I think that our government officials who have generated this list and have done so rapidly have done a terrific job, because practically everything that is in there has a danger to it, and it's often been done in the absence of a lot of detailed knowledge. People have had to have the best guess, and it was done with the emphasis of trying to protect. So one of the ways in which things get on the select lis is it by historical use, use by a military, did it cause a pandemic in the past, or judgment call. However, this has raised many issues. It's certainly not suitable for new ages. Many microbes influence it. It doesn't appear to be based, at least not firsthand, from what you read on microbial pathogenesis, but I'm sure it's because the individual who drew up this list happened to ne about microbial pathogenesis. It is often species-based, and that is too broad. For example, I'm not very pathogenic, yet they are still considered. So if you after drop in a vir you lent one, it is still the same. To make it sairvetion I would ask does it make it safe or more vulnerable? So I began trying to come one a way of weapon potential and we made a few assumptions that each Mike croab has a weapon potential, and this is potentially quantifiable. And here you have the problem again that you can define from the the -- you heed to have a theory of microbial pathogenesis. For this, visual disturbances, we use the damage response framework which is something that we proposed several years ago in which basically looks at the problem only as an interact shun from a microbe and a host. And it is based on -- there are three basic tenets which beliefs are obvious and uncontrovertible. You have to have two entities. So if the host is resistant, been immunized, it doesn't really matter. The microbe is not like toll cause disease. The damage can come from host, the microbe, or both, and there is some sort of function that will define it. And when you go to a textbook and you begin reading, before I show you the function, just to point out, if you look at damage as a function of the host response, there will be some mathematical function that will fit the interact shun, and if you look at it as a function of time, you will have the state of the whole microbe interaction. Infection, persistens, or disease. The basic relationship for the framework is this. And what you see is for most microbes that cause disease, you tend to have a lot of host damage when there's a very weak immune system or when there is a very strong immune system where the damage is coming from the -- from the host, and what you really want is to be somewhere in the middle. I think here microbial pathogenesis could help even on the work of this committee. You can draw the curve below and see how negative damage is a benefit, and this could easily incorporate it. Now, if you look at bio weapons, when viewed from the damage response framework what a weapon you want is damage all across the entire spectrum, and you also would like, because generally people want the damage as rapid as a function of time. So biological weapons tend to cause a lot of damage in a short time. When you look at the select agents list, you find that by and large most of them do this. So we want to be generate a weapon potential relationship and we thought that weapon potential had to be based some where in microbial pathogenesis. It had to be somehow a function of the technological capacity of the ago greesor, then needs to have a human element, a human behavior, panic, et cetera. initially we have dealt only with this part because the other parts, the implication, again, the thought being that we wanted to come up with something that would allow to us put a relative measure for increased damage within a short time. Now to do that, we needed to work out a better definition for virolent. We defined it as the relative capacity of a Mike croab to cause damage. It doesn't really help you in ranking microbes. We came one a quantitative one, the fraction of a symptomatic inoculant. So you can now see that organisms, with a very low innoculum, areappear to have a great virolence. The weapon potential of a microbe is influenced by the commune ka bill tee, the stability and the time, and the time could be equal to one if the ago greesor is willing to wait forever. If you now put this set of this variables to the maximum you could have, at least in this scale, a weapon potential maximum of 100. So we set out to do some sample calculations by taking data from the liter tiewmplt I would tell that you one of the things that is immediately apparent is that we lack the basic information to make weapon potential calculation, even with this very simple type of relationship for most of the agents that are already known to be pathogenic. We don't really know the innoculum that is necessary to cause disease. We have only guesses of stability, et cetera. So basically taking numbers from the literature, taking numbers from mrveg key studies, assuming no communicability, you end up with a negative four out of a possible 100. We then play with other organisms and you can see that vareola is about a hundred fold greater, and a fungal, a human commensas, is very low, but it is not zero. Now, one interesting thing is HIV. HIV is not on the list. However, anyone who knows about what is happening in Africa can see that this organism is essential repopulating certain areas of the continent. It is almost equivalent, if you think about it, as a strategic weapon. You -- we play with it, and if you take the element of time, it doesn't score very high, but if you forget about time it is significantly high in terms of its weapon potential. We used to the estimate the weapon potential of SARS, and as you can see it came significantly high. Now, one point that I want to convey is that deliverability and immunity changes the weapon potential over time. So none of these things are fixed. If you think back to when the germfare disease was first accepted at the end of the 19th century, beginning of the 20th century, cultures introduced, the molecular biology revolution this is the time of the cold war. For example, it was not biological weapon in 1890 because the technology was not there for weaponizing it. In 2004, it is. For example, the viruses would not have been there because they could not be grown. They condition grown now. You can begin to think and extrapolate, will these agents on the list are going to be biological weapons in 2020? If you were to vaccinate everyone, then it loses its weapon potential. Variola was probably not a major biological weapon in 1945 because everyone was vac sin thaitd. And it raises the question what happens with organisms in when we're very successful, such as poly 0 virus and measles is. If we stop vaccinating, you'll eradicate the Mike croab. So my last slide, some closing personal thoughts, they're all potential weapons in some manner. You may to have do something to them, for example, to convert them into biological weapons, but I would say to you you have to also do something to bacisin, in which case it is -- the weapon potential is a function of the sues Septemberability of the population and the decision to draw the line is political, and I mean political in a good sense. It is political in the sense of the politics of having deliberate people think through as to where they're going to draw the line. But it is not going to be the tunnel vision where you're going to be able to say this is safe and this isn't. The placing of microbes into the list may be an act of dual use. I believe the regulations that inhibit research make society and make us and the entire planet more vulnerable. The weapon potential of a microbe changes with time. Public health success create weapons. For example, small pox. The same thing may happen to the polio virus of tomorrow. What we need is the line in the sand for the sands shift with time. I think a great advances, to all those individuals who have labored to come up with a list and to try to understand the threat on the presence but we need to begin to think past that, because a lot of the threats are probably out there. And I leave you -- I said to you the damage framework can be used not only for thinking about microbial pathogenesis, but perhaps it can give us a hint on how to approach the work with this committee. You can see the slide, you can have societal damage, you could have anarchy on one line, or you could have a police state. I would argue that damage occurs at both ends, and what you want to do is try to find through interaction, research, some way in which you limit down here with the realization that this may never ever get tottom. Thank you.

Thank you, arrest tor ro. our second presentation will be given by Dr. Ron Atlas. Dr. Atlas is the graduate Dean, professor of biology and codirector of the center for the deterrence of biowarfare and bioterrorism at the university of Louisville. He was many of the national research council's committee on practices to prevent the destructive application of biotechnology, and he will discuss his perspective on the experiments of concern that were outlined in that committee's report entitled biotechnology research in the age of terrorism, otherwise known to most of us at the fink report. Dr. Atlas.

Thank you, Paul, and thank you to the committee for the opportunity to present to you I guess my own views on what we collectively did in the fink committee, the committee that, in fact, led to your existence and meeting today. I'm going to address the criteria that we use in the system of architecture that we proposed leading to the NSABB. The report that's referred to and which presumably everybody in the room has read and memorized and will quiz me on is called biotechnology research in the age of terrorism. There were points where we had words like dual use in the title, and we had other things at points, but this is what we, in fact, wound up with in the committee. I think that as a starting point I want to give you two very different perspectives on how one would look at dual use. The first, which I'd argue dominated many of the international discussions of the biological weapons convention that did not result in a verification protocol had to do with the concept of dual use as someone trying to do something bad but hiding it behind a legitimate activity. So you really had had a biological weapons facility, you were trying to grow large amounts of anthrax to do harm, but you said, I have a vaccine production facility, so I can hide it behind that, or I have some other sort of facility. I would argue that is not what the Fink committee dealt W. rather what we dealt with was the activities that those of us in the scientific community carry out every day. Legitimate activities and the potential force or version of those activities who, in the terms of dual use, would in fact, seek to do harm with the legitimate activities and the legitimate beneficial knowledge base that we are trying to generate. And it was really in that latter vein of trying to limit the potential for sub version that we proposed the architecture that involves the NSABB. In fact, what we, in my view, did was to try to help protect the life sciences, so that when we hear claims that regulation or the formation of the NSABB or the involvement of government impact is harmful to the life sciences research endeavor, I would argue what we were trying to propose was a system to protect it and to maintain the public trust upon which science, in fact, depends. And what we said was at a number of stages, we, within the scientific community, would look at what we're doing and try to judge the potential for the misapplication of the knowledge we propose to generate. And had that we might, ourselves, then, as responsible citizens, did he some limits on knowledge. Now, that's important to some of my colleagues who say that science is value-neutral, that all knowledge has no value, good or evil, and that, therefore, there shoe be no consideration given whatsoever to limiting something. I would argue that the very prohibitions of the biological weapons convention that says one should not develop biologicalor stockpile those weapons, in fact, already accepts it at the international level, the concept that there are certain things we just will not do. And I go from there. We then define seven chases of experiments of concern. And those are shown here. They are different than the approach that was discussed in the last presentation in that these are process-based. They are not based on select agents or trying to define an organism that would be a weapon or trying to limit our research or in any way constrain research with anthrax or small pox. Rather, it was based in part on the original NIH recombinant guidelines which began to say there were certain types of experiments that we'd be concerned about. One of the ones in the original recombinant guidelines was that if you add therapeutically useful antimicrobe, that organism would potentially be dangerous. We extended that to vaccines, then we looked at virulence and host range and detection, then finally weaponization. I think this has at points been misinterpreted. We in no way said these were experiments that should not be done. Rather, if we're going to have a system of oversight that looks at all of the life sciences and says, where might danger be? Is there anyplace, albeit very limited, that we would constrain what we in the scientific community would either ask in the way of a research question or make publicly known to one and all, which rocks would you look under? And what we said, almost two years ago now, was that at that point in time, these were the seven places where we would look for, we were, I think, quite clear in saying this was not going to be a static list. The NSABB would be charged with continuously looking at this list and updating. I would share with you that during the deliberations of the committee there were individuals who said there are no rocks to look under. Everything is okay. And there were others who brought doom and gloom to the committee, particularly with the knowledge base of genomes and the human genome and various pathogens and their genomes, and the committee rejected those alarmist call, or viewed them as alarmist at that point and said that really right now, okay, two years ago, the concern was with microbial pathogens. It was with microbes as weapons, not with direct attacks. We did, however, see that in the future you would have to deal with the possibility of vectors that would introduce genomes direct intool human populations that might alter our moods, our behavior, our survival, whatever one might think of in that range. We were not prepared to put that on the list at that point. We restricted it to the potential of microbes as weapons and all we said was, if you're looking at that time whole universe, everywhere in this room, and you want to have this board and have IBCs and other ask questions, ask first to check the box. Check one of these seven categories, then have a discussion about it. And the discussion would result in some judgment within the community as to whether there was a clear and imminent danger, was this, in fact, like toll cause more harm than good? And we left it at a very grn you Lar level with the hope that this board would then provide all the guidance that we would need in the scientific community to know where we were going. So I've been quoted often in the press assaying I've been waiting for to you come on board and help us understand really where within this list and where else we would go. One of the things you don't see on this list that we, frankly, did not anticipate, but is the news item of the week this week, was studies on vulnerability. That is, we pictured biotechnology in terms of someone actually going into the laboratory carrying out a life sciences experiment and looking to generate knowledge. We were not picturing someone sitting back and saying, in mathematical scientific sense or otherwise, here's where harm might come, and so we avoided, if you will, a category that you're going to have to think about, and that is how close to a Road map to some other sorts of nonlaboratory studies go. As I say, these were experiments in the near term. You now need to think in the longer term, in my view. We knew these would change as advances of technology. We've already seen significant advances. You already have more things to deal with and, again, these were process rather than organism based, and thatnscious decision on the part of the committee, in my view. Again, we didn't propose any sort of ban on these rather it was a filter, it was a simple way of looking at the world and trying to reduce the complexity to something that IBCs might, in fact, be able to do it. I hope you can provide the additional guidance that we need. Thank you.

Thanks, Ron. So our next speaker will be Dr. David Franz. Dr. Franz is a member of the NRC's fink committee and is also a member of the NSABB. He is vice president and chief biological scientist at the Midwest research institute, director of the national agricultural center at Kansas state university and deputy director of the center for emergency care and disaster preparedness at the university of Alabama at Birmingham. Dr. Franz will talk about parameters for defining dual-use research. Dr. Franz.

Thanks a lot, Paul. Well, you'll see, to start with, I changed my title. I agreed to speak on whatever that other title was about three weeks ago, and many of you in the od know how it's real easy to agree to almost anything three weeks away. Night before last I looked it up to see what I was supposed to speak on, and I thought it was a little presumptuous of me to be able to provide that kind of information to the committee, so I changed it slightly. What I would like to talk about is the -- really, David, fighting the last war, but I think it might be useful background for the committee as we move forward. Before I do that I'd like to just go through two slides that are a perspective of mine that I've developed over the last number of years. First of all, the difference between biological warfare and bioterrorism. And I mentioned early they are morning that when I started in this business we were thinking about biological warfare, we were thinking of a cloud of Soviet made bugs coming across the gap against our forces in some war with the former Soviet union. There we were facing dual-use facilities, equipment, and people. Difficult problems at that time. It was a tough -- it was a tough intelligence target for to us know what was going on in nation states at that time. And we also lacked real-time detection capabilities, which essentially we still lack. We've gotten a lot better than we were, but we still aren't where we are with chemical agents, where if a cloud came into this room we could have detectors that would tell us in time to put on masks. We're not very close to that. Those are biological warfare problems. They're also bioterrorism problems, but in addition in bioterrorism we face the problem of the extremely small footprint of the facility in which agents might be developed, then the agent, or the weapons themselves. And as we all know, the difficulty with attribution. I think biological weapons are special. As we've discussed already this morning, almost anyone could make weapons of some kind. Maybe not what we saw in the anthrax letters, but he is special whl we're talking about highly contagious agents, agricultural agents or in some cases human agent, almost anyone would do that if they had access to the agents and the will to do so. The agents will be available in nature. We're not going to outlaw them. The tools are getting better, and our understanding of the tools are getting better. And because of the ubiquity of the tools and the bugs and the fact that they're legal and a focus of this committee, that they're necessary actually for good. Intent, I think, becomes an extremely important part of the equation. And as the technical barriers have come down and will continue to drop over the next 20 years, I think intent will be an even more important part of the equation. I mentioned my frame of reference this morning, and here we go back to the fighting the last war. Certainly mine is one of military medical biological defense this is sort of where I grew up in this field. Some infectious disease research for the military, and then I was greatly influenced by my time with unscom and the trilaterals, the U.S.-U.K. agreement to reduce the likelihood that the Russians would continue their program. Then the threat reduction program that I mentioned as well. In that context, and with that background, I'd like to look briefly at -- and this is a little bit historical -- the dual use nature of people, facilities, and equipment. First of all, people. When I stood there at Al-kendi veterinary facilities and looked into the eyes of the doctor, I was wondering if she was a weaponeer at that time. I didn't know. I didn't know her intent. She was a scientist trained in the west and in a discipline not unlike mine. We talked about science, we talked about a lot of common things, but it was still difficult to understand intent. At that time, I was on that side of the intent barrier. A couple years later, I was proud to accept the colors of yssamarid -- I don't think Ernie is here anymore, but the general handed them to me, and it was my lab toamplt I was very proud to be the commander. But then I faced some of the same criticisms by people who didn't understand or didn't really believe our intent. And I think this is an issue that we will be facing in this country, both domestically and internationally, some of our colleagues internationally and some of our scientific colleagues in this country will be concerned in the future with some of the research that we will be doing, defensive research that we will be doing to protect our citizens. So it's not always us on one side or the other of that intent equation. I think late 90s I saw the value, as again I mentioned earlier, of science as a common language, and this is one of the first meetings I attended where there was a combination of many former Soviet union, Warsaw pact scientists that had been involved in offensive programs and many of us that had been involved in did he fencive programs, or just in science in the west, and it was here that I first really became aware of the importance of communication, of open discussion, and of working together on common problems if we can, and you can look at these picture, and it's pretty hard to tell in tents there. We all look pretty much alike, don't we. I was also influenced by Dr. David Huxel who was the commander when I first came there. And this was -- we called it the Huxel hairpin, or the Huxel antibody, I think, when he developed this. It was some of the early thought in the late '80s with regard to dual use. And I know there came a point when we were told not to use in this any of our briefings, because it was wrong. I have it here for historical reasons. But it was good enough for me because I didn't have experience. When I went to oba-linsk, one of the former closed Soviet cities, it became very clear to me this concept of dual use, or development of certain facilities for the production of biological warfare agents, and then others that could go either way. But this was one that was a real lesson to me when I walked in there. That one didn't look like a vaccine facility to me, especially the suites on up thar floors. Then in the following years I have had the opportunity to look at a number of other facilities. El-hocham in Europe, it was hard to tell. It was called a single-use protein facility, but if you looked into the science and the actual capabilities that would be brought into question. But it wasn't nearly as single use as what I had seen in the former Soviet union. Yssamarid on the right could be considered a dual-use facility. Vector, down on the bottom right, looked less single use to me than oba-linsk had. It could go either way. A massive, massive program, but a different kind of a program. And now, today, and in the few years to come, the N I A ID will be fund ago lot of containment facilities, like one in the lower left that I will be responsible for when that's completed in next August. A containment facility, work with humans and animal pathogens, and there will always be the issue, in facilities, of dual use and of intent. Equipment is is another issue. European fermenters that we saw in that facility could be used for legitimate purposes, or they could be used to grow weapons agents. The enormous facilities that we saw in the former Soviet union could be used either way. A fermenter like this could be used to grow bought you line um toxins, or could it be used to grow the toxin as a weapons agent. Other pieces of equipment, an orbital shaker, dual use. Freeze-dryers, dual use everywhere in all of these facilities. Iraq, U.S., rush sha. here, a perfectly legitimate activity in a warm room of growing clostridium and vaccines to protect goats and sheep could also be a great facility in which to grow bought you line um or other -- bought you the line numb or other anerobes. Things as mundane as pure water supply that you might need for a vaccine facility you might also need for a warfare facility, things like plate and frame filters. I had never heard of one until I started going on these missions and Bill Patrick explained to me that we used them in our old program to clean up media and tolls clean up liquids, liquid formulations of agents. Very dual use. The ubiquitous double-ended autoclave that we have tense of in this country were always an indication of a potential problem when we visited on these inspections. And then generating aerosols, a class 3 hood line of listed agents, the select agent list. In this case, to make vaccines, they could also be done in order toe valuate biological agent. Now, this isn't very dual use. This was a mig with a -- refitted with some French mirage equipment to deliver a liquid slurry of a bacilus sim you lant. But this one used for crop dusting could be dual use. You might fly one way one day to spray your wheat fields, and fly the other way and modify the nozzle slightly another day to test the release, or the dissim nation of biological agents. And actual most of our time on these inspections was like putting together puzzles. What's that? What's that? That looks kind of dangerous. Is that a dual use item? And there's -- that looks like a controller for a fermenter. Wonder what that was used for some so very difficult problems. As we've heard from other speakers, there aren't bright lines in these -- when you're thinking about dual use, whether it is people or whether it is facilities or whether it is equipment. With this little bit of history, I would add that I really believe that Iraq, the issue we dealt with, issues we dealt with there under unscom and then under imovec later, the former Soviet union, and really the entire '90s are probably easier, and were easier, than the kinds of problems we face today, for a number of reasons. The bugs are still available, the technologies are getting better and are going to continue to get better, our understanding will get better, the terrorist's footprint is much smaller. It's a much smaller world today. We don't have big oceans and friendly neighbors on the north and south. We still have them, but they don't protect us like they did before. And I think as a result, intent becomes even more important. So when I look at the cost of safety and security, and in this case as depicted by these pictures, sort of from both sides we have to consider that. I think about maybe first about regulation. Can't we control this? There must be a way to make us safer. Then I think about progress and feel, well, if we over regulate, we're going throim it progress, and we absolutely can't afford to do that, because this has already been stated. Much more goodwill come from science than ill. And I start thinking about intent. Perception becomes very important. And when you think about perception, education becomes very important and communication, and this -- I don't know that Ron mentioned it, but one of the major focuses of our thought on the Fink committee was this concept of education and awareness and building the kind of culture that was mentioned this morning. And then finally, balance in all of these areas. I think we have to seek that balance as we move forward. Thank you.

Thanks, Dave. So at this point we'd like to open the floor up to the committee members, both the appointed committee members and the ex oficio members to ask questions in particular to the speakers but also make comments on your own. Just to get the ball rolling, I will address this to I guess Ron or Dave in particular, but, Dave, you mentioned, of course, one of the dual-use factors that you were concerned about were people, and while in the days of the bio weaponeers this might have been readily definable, as someone who worked on a biological weapon for a state, these days we kind of face a similar issue concerning training of new scientists in the area of, you know, bio safety containment and pathogens, and at least in the case of selective agents, people who work with these pathogens have to undergo a Department of Justice background check these days, and that pretty much eliminates foreign students and foreign post-docs from having access to these agents. I was wondering if you or Ron, sirngs Ron, you're involved in a lot vied you indicational process seerksz what's the effect of the current regulations on training of students and experts in our society, and what do you see as the future there?

I guess the answer, which I would give, which was used in crafting the select agent regulations is that it should have minimal effect. It's a system aimed at developing a basis for trusting those you have in the laboratory, but the select agent rule did not eliminate foreign students, post-docs, visiting skol Lars, from participating. Yes, it required a clearance process, but the only exclusions were ale I will freeness a very limited number of countries which would have essential no impact on the scientific endeavor. So I think that it's important to stay with the mandate that the Congress gave in enacting that regulation which, like everything else in this field, is aimed at to the maximum extent possible we have openness in science and only in very few very carefully defined and very narrowly defined areas do we do anything to constrain that. .

I guess I would just come back and say that sometime the intent and then the practice can differ. In the case of the select agent, a my laboratory has had a select agent license since the late 1990s. In fact, when we first received our select agent license we were required to pay a fee of $13,000 because Congress had not appropriated any money to run the program. And over those years, my experience with the select agent rules has been that, in fact, it does impede or at least slow progress. My question is, in the balance of things, is that a good thing or a bad thing, and I think that's a bigger question. In the case of the background checks, it's often hard to get a background check done on a 14th national just because the records are not as readily available, so the time line can become prohibitive. Here's an example where we didn't intend to I am feed actions but the practice of making it work can do so.

I had the luxury of work in my laboratory with an agent that's nonsleek, but we have a lot of agents that do work with select agents and are registered for that purpose. One of the effects is is is with American graduates going through the various clearances required to get them into the laboratory, makes it very difficult for them to enter those labs on rotation as graduate students which provides a disadvantage to the faculty who work on this it's probably an unintended consequence of wall intended regulation. It's a little difficult to work through. Might we improve that impediment by more rapid procedures? But hat been difficult.

Just to add to the collection of anecdotes, my laboratory works on developing antibody therapies, for developing therapies, and to work with bacillus, a select agent, you have to have a select license. Now, we don't have that, so we are allowed to work with a vaccine strain, which is the strain that has the toxins but doesn't have the capsule. Turns out we are Al will youked to work with that because it's a vaccine strain in the United States, but there are a lot of other strains, some of them which have the capsule, but they're not on the United States vaccine list, so we can work with those strains even though they're also attenuated, because the select agent basic sel a species, almost kind of a destination. So consequent allot of the work simply cannot get done. It cannot get done, and it's being done with collaborators, and unless I apply for a select license and turn my laboratory into a select teaching laboratory with all the issues that are involved, this work is severely hin dered. We have made rethaghts we cannot test, or not test easily because of the regulations that are in place.

Mike.

Just a question for David. Several times in your slide you referred to the fact that terrorist footprint is much smaller. Can you explain what you mean by that?

I just mean the potential for the use of biological agents, for example, what we saw in the letters, was much smaller than the four rows of 10, 64,000-liter working volumes I showed in one picture, or the enormous, he thor mouse program we saw in the Soviet union in general and the fair size program we saw in Iraq. I think the potential for doing harm in a much smaller facility with a smaller amount of material is is there today that we really didn't think about when we were talking about battlefield weapons.

if I could just add a point to that, is it really the footprint that's smaller, or is it the fact that there's much less material and ultimately the delivery system will still determine whether you have a million of something or ten of something is how much you can deliver over what time to wherever you're delivering it to will ultimately determine what the size of that is. And unfortunately today with the kind of delivery systems which we have, which have improved dramatically, you can much more efficiently deliver, whether it's through air, or through food, much more significant amounts. I guess I'd call it the economy of scale A. terrorist today could probably after footprint of substantial proportion today that they couldn't have accomplished 20 years ago before aerosol particle technology or before the global distribution.

I think we're just using footprint in a different way.

I think it's one thing to think about the anthrax as a very valid observation, but think if that same individual, instead of, or group, instead of using the anthrax spores in letters could just put it in a baggy.

You're talking about the footprint of the aerosol cloud, and I was thinking about the footprint of the system that it takes to cause harm.

I was thinking if you put that same baggy of material in an intake of the building, a large skyscrapers, we'd have had thousands of cases instead of 2 #.

I'd like to address Arturo's points about the vaccine strains of bicillus. It does give a good example of what I think we can give credit to the CDC for implementing in the select agent process, and I think it shows a limitation where a lot of the deliberations were done within the government and a lot more took place and was appear presh crated on the outside. There is a monthly or less frequent, if not needed, scheduled channel meeting of government experts, the inter agency select agent technical advisory working group that deals with issues as they arise, and that's the group that helped to create excluded strains in select agents this is a data-driven process. So individuals can petition the CDC, and Mark Campbell what is here in the audience, might want to comment on this additional with the anthrax situation, because it depends on the risks of the vaccine strain being reconstituted to potential. One of the plasma deficient strains is less -- less of rank than the others but there is a possibility in the process for scientist to go to the CDC point of contact, Mark's office to propose data that show that a listed agent, when modified in compliance of all of the requirements for working with those agents, has lost in a definable way and irrevertable way, the capability toin flikt the same damage that it had before, that it can be delisted. That's an ongoing process but it shows that having a data-driven adjust as you go along system is very useful in approaching these issues. Not locking inon something in stone.

I add comment. I was kind of interested in the focus of the three speakers. In a sense, Dr. Casadevall focused on the organisms, and we have identified, or others I have dent fide, particular organisms, but actually any microbe could be turned into this. Dr. Atlas then spec about the kinds of experiments, seven of which, in which dual purpose may be found. And I think he was right in saying that if you are purposefully creating a weapon, then that is not a dual purpose, it's a single purpose. Often perhaps done innocently but whose publication might alert someone to a dual use, and I think that that is another aspect of the problem. The third, I found even more fascinating, and that was Dr. Franz's argument for the intent. And I think that's a much harder aspect. We are focusing on the organisms, we're to cushion on the kind of experiments, but what about the intent? And looking at your list of, at tend there, of regulation, progress, intent, I really think that temperature few sis should be not on balance but on education. I think it should be on education and communication. Criminals will be criminals, but unless we can help young students to distinguish between what is really good for the world and what is bad for the world we're never going to make it, because someone can always do something wrong. So knowing what can be wrong is one thing, but getting the message out not to do it is, I think, one of our best defenses, and I think getting societies worldwide to agree that there are certain criteria for the good science as opposed to the bad science may go a long way in getting a universal acceptance of good science.

Dr. Cohen first.

Thank you, Paul. Similarly, I have a question regarding the people aspects. Dave, the question really is for you, byed also like Ron to perhaps shed any light that the fink committee may have considered on this issue. My question is people aren't all good or all bad. They also change over time. They're also influenced by circumstances that may have nothing to do with the work. Just life as it goes on outside of the laboratory. So background checks, to whatever extent they might even be effective, do some screening prior to coming into the lab, but in your experience, sort of looking into the eyes of these scientists and asking, are awe weaponeer, do you have any sense of ongoing personal liability, any ways or means to screen or to routinely recheck perhaps any changes of intent? And then, Ron, if you could shed any light on conversations about this that may have come up in the deliberations at NRC, I'd appreciate hearing about that.

With regard to your question about personal liability or surety, are you talking about history her?

No. Someone with a perfectly clean history coming in and working in the lab, and over a period of months or years, having -- becoming compromised, either Ike logically --

and you're asking about Iraq and Russia?

No, not in particular. The I'm just wondering if you have any experience -- the question goes back to the comment that one of the board members made about background screening, comments that you made also about background checks. That fixes a point in time. So someone is brought in and passes a background check. Two years later that person may be someone who would have reason to or could be found out later to be responsible for sabotage or theft in the lab. I'm just wondering if there's any experience you had had or if Ron had had any presentations of background, any deliberations made before the NRC committee dealing with ongoing reliability where otherwise perfectly clean coming into their work, perfectly fine history, but over time, change.

Right. Well, as you know, this is a new world in biology. 15 years ago or 20 years ago would you go to an ASM meeting with a vile in your pocket, probably, at least some people would. But that same 15 or 20 years ago we had surety programs in our chemical community, in our nuclear community, and I have not worked in nuclear, but in chemical I have in the military, and that was an ongoing exal nation. You're looking for psychological factors and so on in individuals. My medical records had add great big stamp on the front of them that said I was in a surety program, and was lacked at all the time. Those kinds of things, as you know, now have moved to biology, and I haven't been involved in that area since they have moved, and I don't know exactly how they have changed. And I think it's primarily in the DoD, is that right, the surety programs are primarily in DoD research, not in any of the others. But that, in my experience, changes the way you do research, in that it makes -- it slows progress a bit, but it has to be done very objectively and very carefully in order to limit progress as much as possible. So certainly eve had experience in the programs, but not really experience with change in individuals.

I guess I have a question for Dave also regarding intent, and that is that assuming that we're dealing with your average, you know, university lab toarks or even industrial laboratory, and assuming that there is a code that we all agree on and everyone signs on to, then I wonder how you envision assessing it, and is that really going to be possible? Because in a lot of these things may be inadvertent.

I had always hoped DARPA would develop an intent meter that we could put on people's heads.

they are working on it. [ LAUGHTER ]

But the general approach that I believe was taken before surety and it might get a little bet we are surety but intent, we still won't measure intent, was to work with people for a long time before you take them into, he is special into BL-4 suites. I would Zane my laboratory, 5% of the staff got into BL-4, and maybe 20% into BL-3. Most people worked in the cold all the time. I'm just guessing at those numbers. I don't know that that's exactly right. But it's a small number that go into BL-4. And I can think of some of my division chiefs who worked and work and worked with people side by side for a long time before they would ever let them go in, still not you know act companied, but with someone else, to be very comfortable. That's what it's all about inbiology. In nuclear or chemical matters, you can have meters or ways of measuring how much is being taken out or how much someone has, in biology it's that much. And so it depends on people, and that's always going to be a difficult problem, but I think open communication and working close and education, as was mentioned, a huge subpoena is porter vied you indication, and awareness are the way we're going to have to go.

You have to eventually trust, certainly.

Thank you. I think this is a really important issue particular toll gear up to complete construction of a large number of BL-4 labs given the number of individuals that today qualify to work in that vircht and the need for a mentoring of a training experience, but the comment I wanted to make is is to Ron, and actually it's a question. Given the fact that we do live in a global community and that if we're going to succeed in this charge it must be a global success, I wonder if you could comment on the international response to the fink report. Has it been noted ab broad, and hat been a favorable response?

I think I've been traveling a great deal internationally talking about the fink report. I think there's a wait and see attitude. Internationally, I still have the sense that there's real fear of what the U.S. government is doing and there's a growing fear that the NIAID bio defense program covers for biological programs, so there's fear of what we're doing. Within the United States I'd argue that the real fear is of bioterrorism of, the misuse of scientific community to do harm and that we see the NAID bio did he fence effort as very beneficial to developing the vaccines, the therapeutics, dying nos stirks and all else that we need to offer protection against that. So there's a different global view. From the fink committee perspective, from day one we saw this as needing global outreach. The model that we used was the recombinant DNA debate, which I would argue, for better or worse, started with the conversation in the United States but then throed where the oecd and the WHoh developed parallel structures so that we began to have a global agreement on the safe conduct of recombinant DNA research, and the fink committee was hoping that this would not be a walled off U.S. evident but would be a dialogue internationally and called on us to move forward that way, called on you and the NSABB to move forward that way without that I don't see much value, frankly, in any of the efforts that we might be conducting.

I would just add to that, that the intentional epidemics group at WHoh, I think now Mary Chen, are working on this in collaboration with a number of other countries. And are going to do essentially fink kinds of activities in the seven WHO regions and have plans to do that.

Actually, the doctor just touched on it, and Dr. Franz mentioned it, this idea of a new dimension. In one of our briefing papers by Tucker referred to federally funded laboratories and the notion of -- we've been talking about a lab where you choose the product you want to work object. I wonder, David, if you could comment on research that's now proposed or expanded in some of the new labs that are -- will be stood up by department of homeland defense or DoD and the notion of more directed research and how that might be perceived in the community in the United States as well as abroad.

No, I can't comment specifically object what's going on in -- or planned in those labs. But I think the -- your point about perception is important, and I know I'm already hearing from people in the media that are concerned about your question exactly, and I think it's something we have to take very seriously. There's no question in my mind that we have no intent in this country to violate the weapons agreement, but there are cases where we need to do some classified research, and how do we convince them that it is not contravening the convention. There are domestic -- concerns domestically and there are concerns among our international colleagues. I have often said where we can and when people, if we can collaborate with one of our allies, that might be a way to diffuse some of that internationally and domestically. Likewise, there might be cases where we can talk about '77 and explain the research that's ongoing but maybe not provide the results. If it exposes a vulnerability or compromises us insome way. But I think we can't just ignore it, that issue of perception.

Ied like to comment on the security dimension and focus on the issue of counter intelligence as an analog to the question of dealing with people and security. Obviously in the intelligence community the opposite of intelligence is counter intelligence and security. And we have, of course, very significant processes in place already for clearances for training, for ethics, standards, for poly graphs, for reinvestigations, for expedited investigations, paid investigations. A lot of process that relates to the whole security -- maintenance of security, and the fact of the mat ser that the history of espionage has been that at any given time there are probably two or three bad apples in the system, and if not, more, that the insider threat is the largest threat. The outsider threat clearly is a significant threat, but the insider threat is the threat where the most amount of damage takes place. So I think the message out of that is that you have to have all these things, training, ethics, strksdz process, et cetera, investigations, clearances. It's probably a necessary but not a sufficient condition. One could probably question whether the cost of it in both process and actually in dollar value justifies, you know, the gain that you get out of it, but I suspect there's nothing to replace it now at this particular point. I think the one thing that we have learned from the espionage analog is that good offense, as well as good defense, is an important dimension to this. By that, I mean casting your net widely and, in fact, penetrating hostile intelligence services that are working against you, and this indicates -- in the case of our case study, we would be dealing with whoever the threat agent is. So focusing on the threat agent and the connection between the threat agent and the insider, presuming the insider is not operating on his own, is a very critical dimension here.

I'd like to draw the discussion a little bit back to the technical issue. It strikes me that we're talking about a whole -- should I call in the heterogenous cascade of efforts because we start with fundamental research, and then as the discussion went, we moved on to the actual production methodologies, then, interestingly, weaponization, primarily aerosol. I wonder if I could get a sense, Dave, maybe you could speak to this, in terms of our charter and what we're looking at, it seems that we're looking at more of a global issue than any other -- than anyone would suspect. We're dealing with biosecurity. You would think we're talking about research in the laboratory, but, in fact, we may be getting into the pesticide industry and areas like that that incorporate biologicals. What do you think about that scope? A little bit broader than maybe you first thought?

Well, I think, so and I think that -- I think I heard that in comments from a number of the committee members as we went around the room this morning, and someone else may have a better perspective on it, but I think it the's very, very broad, and it's a moving target, as it was mentioned. This technologies changes. It could be exploited, and there may be areas that we don't understand yet that could be exploited at some point, or accidentally used.

Again, my comment, it's kind of -- it strikes me that it seems our worry meter is quite significant because we're concerned about genomics, which have their own set of problems, all the way to fundamental delivery systems. Sought seems to be more than fundamental research in terms of just biological, but I'm wondering, and it kind of makes me think about getting into the engineering aspects that are related, because if we look at the agents as the fill for the actual weapon itself, the weapon, in fact, may be a cold fogger, or whatever, but it seems like we should worry about everything in toto, rather than just simply how do you alter a agent to make it effective. It may be that we're looking at experimentation for a more efficient dissemination process as well.

well, to follow up on that excellent comment, you have to think that the bacillus used in 2000 one used had to attack are in the mail system. The envelope.

Just wanted to expand on that a little bit and see where it takes us, if we just keep reducing it. This is a question for you, arrest tr rorks because it looked like you were trying to do some mathematics, and I appreciate that. There's a lot of opportunity to do mathematical modeling and the question is does that start becoming a select agent. Does one's model start to become a select agent. You obviously have your algorithm that you've developed. Do you think that becomes part of our charge as well?

I think it's part of our charge to discuss it, but I would say to you that clearly any -- I guess anything that you do in this area is to potentially dual use. You could argue, and we thut about this. I mean, if you begin playing with an Al go rhythm,. The way that I reconcile myself to that that was not going to happen, when I began to try to do the calculation, I realized that the data was not there. So that it was, in fact, more important to alert people that if you're going to evaluate the weapon potential of meningitis, you may not, in fact be able to. And that provides with you an opportunity for protection. Because the exercise shows what you you need to do and shows you where your liabilities are and your vulnerabilities.

I think, just to follow up this is a very critical point, because I think far too often we look at biosecurity and agents as a laboratory-based function. To me this is like cooking a soufflet. You can either somehow invent a much better egg, or you can get a much better skillet, which is a means of transmitting it, or you can basically give away a heck of a recipe, which is basically how to do it all, and today we have to worry about all three. We have to worry about someone making a better bug, can they disseminate it better, or could it be that they wouldn't have all the pieces but could get the component parts. That was recently referred to this morning is that does that meet that third standard of now making it much more available to someone who might otherwise put it all together. And you think our purview really has to include all three of those issues, because in a serngs as you've pointed out very nicely, the equation on the bug is partly bug delivery and all the information.

so you recognize now I think that was the paper by an economist or something, and our place there, our engineers working on these kinds of issues, people at the wharton school doing analysis on vulnerability of networks. So we're now going to have people in the wharton school applying to the IDC to do their kind of work. So the reach of this committee is becoming, up, like an octopus. It really seems that we may to have think about drawing boundaries somewhere or else we'll be here forever, even though we're told we're only here for four years.

I don't think my comment was meant to suggest that. My comment was around biologic agents first of all. Second, pretty much around the agents and the means to transmit that agent in a more efficient way. One of the things we for get, technology is just -- is not just around growing bugs, it's how to deliver them. Aerosol technology has improved to the point where today I can go out and buy devices at various lek tronic shops, and so part of it we have to understand it's the combination. But the third piece, which is key is not just computational. I don't want to suggest it's all things. But if you give somebody now where is the important node, where does it get by, let me use this example from the food standpoint. For the last 15 years we have basically approached food safety from the standpoint of hazardous analysis critical control standpoint where we try to figure out where are all the vulnerable nodes that might, in fact, create a food problem. Today those plans are the very blunt for a food terrorist because mow they know everything in the system we have to take dare of mother nature, and if we get past that last block, and now you can do it, you're home free, and so in a case like that by taking that plan, and putting that together in the right setting, you literally give somebody a step-by-step blow of how to do it. And I think that's one of things we have to also consider. Does that information now become also a critical piece of biosecurity, safety, and I would say both prevention and response.

Just to add, the question of the engineering, I think my perspective would be that the closer you come to a true delivery system is, the closer you come to a real Road map, that's where you get most concern, because it becomes a clear and imminent danger. I think that you may debate for a long time on the fundamental knowledge side, the gee noams and the sequences. In the end you can point that that will, as technology advances, as knowledge base advances, risks will be there. Accept that. That's going to be the case. I don't think that you can constrain that or you should consider constraining that, because that's really the basis on which we advance the science. The question is when you get towards development, if you look at that time biological weapons convention, it really starts at the level of development. When does research really get real close to development, when is it a Road map, when is it a technology that is clear and imminent in its danger. I think that's really where you're going to find yourselves being driven. At least, that's where I've been driven in much of my consideration.

I like the concept of looking at vulnerabilities as a metric for understanding where unusual risk may exist, but vulnerabilities, of course, also reveal points of intense need for further work, and we all recognize that a flexible, agile, scientific enterprise that understands where there are important needs for research is one that will help us get to where we need to be more quickly. Perhaps we can elaborate upon the idea of focusing on vulnerabilities and luge at situations in which vulnerabilities are also accompanied by untoward gaps in time before which we will have any suitable defense. As a place where there is -- where there are special vulnerabilities and places where we might focus our efforts. The idea of identifying maps, Road maps, is a tough one, because many fundamentally important papers in mechanisms behind virulence are, in fact, blueprints for constructing strains or biological agents of potential untoward effect. So I think that does get back to intent sometimes and emphasize the importance of looking at vulnerabilities and what we might be able to learn from that circumstance that helps us understand where those few places are where the gray turns dark.

I guess I'd like to be reassured that good sigh Nancy can help us in the area of infectious disease will not be destroyed because of the fear that it will end up to be a Road map. I think what Arturo told us this afternoon, and Dr. Lemon mentioned this morning, is that we need a lot more research to understand how infectious disease microbes move. It's pretty obvious that even particular disease agents we've identified, or newly identified ones, the sooner woe know how they're trabs mid, the faster we can move to eliminate their spread. Sew I would move very strongly towards increasing research on disease spread, which which we really only know very little, a little bit in the hospital, a little bit of hand washing, but I would hope there would be more effort in that regard and not worry about whether that would open up some area, new area, new Road map, other dual use. And I'd like to have your copments on that, Arturo. How do you feel? You did that research and you found there wasn't much information.

I mean, I think so. And I would also point out that the benefit that accrue are often very difficult to rationalize. For example, there are research efforts that look at anthrax toxins, in the treatment of cancer. So even research that is is -- what appears to be biodefense relate, or in some ways military related, may have tremendous pay I don't haves in the nondefense arena. And I will ask to you think about a lot of the technological advances of the 20th century and to the degree in which that we're further along by, in fact, some of the thoughts or some of the developments that were used, for example, the jet engine, satellites, some of the micro electronics. So it's conceivable that as money is spent in infectious diseases, that you will also see had advances in areas that you would not necessarily expect right now.

I east just been reminded that this committee is in fact, supposed to provide guidance, leadership regarding biosecurity oversight of dual use research. And so much of our discussion is starting to move away from research alone but just a quick reminder about that.

I will make a comment, I agree 100%, what he is saying about research, it reminds me about the arguments that have been going on the last decade regarding where there was a strong sense that we should destroy it because we had mapped it and everything was okay, and I think that has quieted down now that it presents itself as significant threat agent, and we don't owe he we found out we don't know as much about it as we thought we did. So that's the -- kind of the argument made. We may think we're very, very berate right now. We know a whole lot about disease mechanisms and causeative agents, only to find out later on we have taken a position to eliminate a line of is reseven, or in this case a particular agent. In fact, once it's gone, it's gone. So I would argue that we need to go very, very softly in terms of trying to make recommendations to regulate research and think it through a lot.

I'd like to come back to a point that Mike was making a moment ago. Mike, you were talking about, in fact, the threat is really a multiple stage thing, and what you have to have all components. Is it possible to define key components that, in fact, we can deem these key components as safety valves, and so we can work up until that point? I mean, the analogy would be that the select agent rule, in fact, has locked up bacillus antrasis. Does that mean we can go ahead and do research on other aspect of the process?

It's like the chain vin feck shun. You can break it at any one point. You basically put the governor on sought that you minimize the situation. You can have a relatively milder agent in the sense of the relationship between disease causation in humans but a much better twie disseminate it or you can have a really hot agent and I would argue from a psychological impact I couldn't distinguish them right now unsociety. And so I think that part of it is we've got to wrestle with those things. We just don't know. I think that's part of what we're also dealing with here. I would suggest to you -- let me give an example. It was referred to earlier here in the meeting about the situation several years ago when a group of researchers de no vo created the polio vaccine. Had that had same polio virus created an epidemic because it accidentally got out, somebody just wanted to see if it would work, I can guarantee that you had the right connotation of terrorism intent been out there that would have created a panic that clearly would not have been equivalent to 9/11 post-anthrax, but that would have created a major, major issue, because it was that psychological impact that, in fact, it was manmade, that it was an agent we thought we got rid of, and when it comes back does, that make it even worse? So there could have been a very simple situation of just eating some food, but it was having that agent available. So I think there's so many permutations, I would be fearful to say this is the absolute combination, but each one, just like mother nature made one, we're looking at agents, mode of transmission, then understanding the psychological impact of what that might be. So I think the model is right. I just don't know if we can put an equation.

Just to maybe restate what you said there, even though the entire process of a bioterrorism or bio weapons event would require multiple components we can't really be sure we though that well enough in order to say that, yeah, it's okay to work on four of the five, we really need to be looking at each one individually. Meeting in recess. Please stand by.

Today we will have insights into the need for balance between national security, science progress and the need for individual scientists to become engaged in the process. Welcome Dr. Fauci.

Thank you very much. It is a pleasure to be here. I first want to apologize to the members and to the audience about my coming that the particular time. Some of you may know the original schedule had me speaking early in the process almost as an interintroductory but unfortunately I spent the entire morning and part of the early afternoon on a congressional hearing on pan dem mix flu pandemic flu. As I was taking the metro here it doesn't mat -- make any difference what you throw at me after what I have been through this morning. I do know having said that that what I'm going to say is going to have an overlap and repetitiveness of what has already had to have been said in the early part of the session. So what I'm going to do is very rapidly go through some of the slides. I'm not going to speak very long, I promise you. To rapidly go through the slides and focus on one or two points again that I know has probably been addressed but I just want to underscore it because I really think it is extremely important. You heard the background about the concern mounting about real threats that we are facing, we as a nation and those of us who are in the government working to both detect planned for and ultimately develop counter measures for potential threats of biological, radio logical and creme chemical war fare. It as research endeavor. Early on when there was a discussion into government about where the resources would be put to develop counter measures and it became very clear that the best thing to do would be to put it into the hands of the scientific community in -- in a way that by very nature the scientific commune sit fundamentally a transparent process. When you are doing into -- getting into an issue of the potential dual use you want to maintain the transparency as the same time that you at least are A-10tive to. So issues of concern of some of the negative aspects of dual use. There have been legislation as you are all familiar with the patriot act of 2001, the public health security and bioterrorism preparedness and response act of '02 and the bioterrorism act of '02 improving the nation's ability to respond to bioterrorism and other push -- public health emergencies. When you are aware of as we search are aware of the dual use dilemma as we call it, there are certain as a results, if not experiments themselves into development of technologies and information which have naturally raised biosecurity concerns that go beyond the immediate concerns of physical containment whether you are going to do something in the BSL3 or BSL4 and the usual issues that arise when you talk about containment. You're very familiar, I know, with the fink report which tried to address some of the issues of research in an arena of terrorism and how we have to maintain the open scientific discourse at the same time that we, in fact, address the concerns that we have. Right from the very beginning the discussion of how we can make this anal analogous to the original Recombinant DNA Advisory Committee because that has a very important history that isn't totally analogous to what we are doing but analogous enough that we fashioned the development of the NSABB according to the fundamental principles. One of which in particular I'll mention in a moment. We -- we go back to the '70s and we see that what the scientists and the regulators in the 1970s had to face is not that much different from what we are looking at right now and if you look at what the RAC has done, it serves as a public forum for the in depth review and discussion of all of the aspects. There are internationally accepted guidelines for the oversight of recombinant DNA research and importantly it really supplanted what was felt at the time as a burning need on the part of the Congress to formally legislate oversight of these activities. Not that that is bad in and of itself but the potential for interfering with scientific discourse and scientific experimentation was real and very little of that had to take place because the RAC was originally directed to provide provided a -- advice, guidance and leadership and that is what we want and hopefully will have the NSABB do. We got asked early on in a number of congressional hearings as this was unfolding, the development of the NSABB, is about what about the clout. What kind of enforcement, what kind of security can you be responsible for. And it took us awhile to get the message across that I want to reiterate now that we are not going to be the policemen against the bad guys. We're going to try and set up as we show here a culture of responsibility and framework and guidelines for how different agencies, the secretary of HHS, the director of the NIH and the heads of all of the other relevant agencies, which is why the NSABB and its members if not ex officio members really cover the entire waterfront of federal agencies to provide for them the kind of advice and input so that we can run on what we are calling the culture of responsibility. And the culture of responsibility is to try and set a framework so that the work that is supported by the federal government, which is the only arena that -- we can actually have true enforcement capability and enforcement in the sense of if you are getting federal government funds then you deliberately or even without deliberate but nonetheless do go against certain guidelines that federal funding can be helped. But if you look at the agenda there are a lot of other things that we don't have control over, we the federal government and certainly not this committee which is advisory to the federal government. We don't have control over international, we don't have control of people who do not have government funds in doing the research that they do. We can't tell publishers what they can or cannot publish so what we really need so do is just focus in on what is right here on the slide and that is that culture of responsibility and in that framework to provide the kind of guidance that will allow guidelines to be ultimately accepted by everyone worldwide. Remember, the RAC doesn't have jurisdiction over national issues -- over international issues and if you look at what has happened over the last 30 some odd years with the RAC it has become just acceptd that you would not do something that was not according to the guidelines that were set down by the RAC. In a very indirect way by merely establishing a culture the RAC has been very effective. And in that regard what we want and we are getting here with this committee and the discussions today is an active participation of the research community in the deliberations of the NSABB in an open and transparent way and actually the success of what we do is going to depend on the enormous talent and scientific input that we have into this process. So I'll stop there. Again I apologize for coming late but I just wanted to make sure that I underscored that last point of the spirit of what we are doing and that is that culture of responsibility. Thank you.

Thank you, Dr. Fauci. With that we will move into the next session. The next session is going to focus on a topic that is on the forefront of many professors. The communication of dual use research results methods and technologies. As was true for the previous session the board members will have an opportunity to address the speakers during the panel discussion following the talk so please save your questions and comments until that time. In addition it is important to reiterate that we will form working groups out of this that will focus upon five different top Ixs and in particular this topic, communications and this will afford any one wishing to participate the opportunity to deliberate on these issues in some detail. The first speaker is doctor Judith Reppy who will talk to us about dual use information issues for the NSABB. Dr. Reppy is a professor in the department of science and technology studies and associate director of the peace studies program of Cornell University and she will speak about dual use information issues.

Now, I think I'm ready. I prepared a short statement that is in the briefing books and I think I should go rather quickly through the first few slides because I suspect this overlapped with Dave Francis' presentation to the last pabl. Here I want -- to the last panel. Here I want to emphasize that yont the simple def -- beyond the definition security threats come from nonstate as well as state. The mill tare I users of technology have to be concerned with terrorists as well as with regular armed forces. Biosecurity is intrinsically dual use. Virtually all military uses have a civilian count irpart and many if not all civilian uses are potentially are interest to the military. Now, f we going to talk specifically about dual use information we know that governments have had for a long time an interest in controlling the spread of both technology and disembodied information. During the cold war the coordinating committee for multilateral export controls over saw a list of dual use items that required approval to be ex-pored to the Warsaw treat it organization around other countries of concern. These controls extended information in the United States for instance if you pass scientific information to a foreigner inside the United States that is considered a deemed export and technically leads to subject to licensing such as if you had exported it by mailing your articles abroad. The current [ Indiscernible ] arrangement which followed after the end of the cold war is a many weaker regime. It still has these controls but for a lot of reasons I won't go into it is probably not doing the same job. In biotechnology is not shrewded on -- included on any of these dual technology control lists. It wasn't a matter of interest during that cold war period. The Australia group which was founded in 1985 has stepped into the vacuum to extend control to technologies that might be use Forded for chemical and biological weapons. I'm going emphasize again here that these control issues are agreements among states. And they are rather limited use in combatting terrorism. They also have just a generic problem, it is very difficult to keep up to date when the technology is changing so rapidly because they are working from [ Indiscernible ] so we have a problem safe safeguarding biotechnologies information and I just noted some of the reasons we have that problem. Pathogens are everywhere. Even a small amount can do harm. That is because they -- as you know, they can replicate. Biologists are everywhere and they also are numerous and diverse. And I think it is important to note that you don't have a tradition in biology as you have in, say, nuclear physics are working between the scientific community and the security community, security establishment so there is no real existing base although I suspect one is being constructed right now but no previous base on which to build trust in a regulatory regime. Really comes specifically to the question of information. The challenge is great because again we have the tremendous diversity of journals, over 10,000. You have a well established culture of or circulating conference papers, research proposals and in fen ral -- general a culture of sharing information among the scientists. It is questionable to me at least whether information flow in the life sigh sciences can be controlled in the way that nuclear information has been controlled. I'm certain and I would state categorically that if it is attempted the cool front -- the cost would be very high. Whether it succeeds is questionable. As you know, the think committee considered these issues. It had a difficult task because we needed to balance a very strong need to protect the free flow of information because of its importance to biological sciences and biosecurity -- and biotechnology with the need to protect the information from getting into certain hands. The committee system was a system of self-regulation modeled on the [ Indiscernible ] and RAC process for the local IBCs so review experiments and concerns and the journal editors to review review journal articles. This system I think has a lot of benefits. It relies on existing trusted institutions at the local level. It gives an important role to sigh entities. Should provide a consciousness raising for the life sciences community and avoids the imposition of blanket regulations when there are problem experiments, problem papers they will be dealt with on a case-by-case basis but there are a lot of remaining issues and I want to focus on three of them. I think one question that needs to be better understood is what kinds of information need to be restricted. It is generally recognized among social scientists at least that tested knowledge is an important component of scientific knowledge and particularly the kind of scientific knowledge that many coulds out of laboratories. So in spite of some of the things that you might read in the press it is not so easy for terrorists to replicate a sighen tiffic experiment -- scientific experiment. But you can't rely on it is TACIT knowledge to protect it because over time tacit knowledge can be codified and simply be 11 supplanted by something you can buy. So you can buy a kit, you know, from scientific supply businesses that do a lot of the work that used to have to be done by a trained tech technician. So for that reason you can't just say well, we don't have the knowledge, [ Indiscernible ] you have to think about what kind of breathing time of [ Indiscernible ] it is tacit knowledge may provide at least with respect to the most advanced biotechnology research. As other speakers said I would emphasize that the real problem is the insider problem specifically in this case because it is the insiders that have the tacit knowledge. A second issue that I think is still outstanding is the scope of the regulatory regime. Under the RAC not all industry and government and research is covered. Some is covered voluntarily from organizations that don't have NIH funding but only those organizations receiving NIH funding have to follow those procedures. The the question is is this going to be okay for biosecurity. I think it is an open question. What kind of controls might we want to ex-toned those laboratories not participating in the current IBC. The think committee recommended extended IBC review all relevant institutions but I think we walked away from the idea that we should make a list of those institutions. You guys have to do that. And finally, I think that there is a need to affirm the importance of free exchange of information and particularly with respect to two rather tricky problems. One is the unclassified category. The government has a policy that fundamental research funded by the government should be unrestricted to the maximum extent possible and when restriction is necessary the proper whened method is classification. I think this is very much an open issue whether that will become a kind of creeping category of information that is closed from public circulation or whether it will not. And then there is the issue of classified information. I mean you might consider the fact that it is not covered it is not a problem because the classification after all protects it from circulating freely. But the practice of classification poses its own problem, how to identify information that must be not too broad or it will cut off communication of the open literature. If it's too narrow you raise to a high degree the expertise required to determine what should be classified because each little piece of knowledge has to be in inspected. This is an important issue for the NSABB because any exclusions from the regulatory regime that is being put in place opens loopholes for some kinds of abuse and particularly use of classification to protect activities from public scrutiny. So my conclusions are that there is a lot of work for you. There are useful models that have worked in other control regimes but it is not obvious how useful when they they -- they will be when extended to the bioterrorism question. It is very important to get the right balance. And finally, I wanted to emphasize that although I talked about these problems with respect to the United States any solution has to be acceptable around the world and I know you have been hearing that from everybody and I'm part of that choir and I think that is a very important point. Thank you.

Thank you, Dr. Reppy. All right, so now we will hear from Dr. Thomas Bowles who will share lessons learned by the nuclear physics and cryptography communities particularly relevant for the life science communities. Doctor, Bowles is the chief science officer of Los Alamos National Laboratory and associate professor at the University of Washington.

Thanks very much. I found this to be a very interesting discussion all day long and I think you have a very difficult task laid out in front of you. So I wanted to give you a perspective from someone who has worked in the nuclear physics commune the and also been involved in the cryptography issues at the laboratory, how we dealt with these problems at Los Alamos. Los Alamos is a multipurpose national defense laboratory. Our primary mission is maintaining stewardship of the nation's nuclear stockpile but we have a growing in responding to the weapons of mass destruction. In particular we have a strong bioscience program at Los Alamos which is growing. We have about $60 million of effort a year in it and focused on bioscience and national security and we have a lot of very capable and confident people -- competent people in come pew come pew pew takesal. So we are a spread of activities at the laboratories. Some of them are purely classified such as in the nuclear Wen pops -- weapons program. Some of the research is very fundamental and you might ask what is this doing in a national defense laboratory but we found that you need that breadth of interlegal auk -- intellectual activities to stimulate the staff to provide the core capabilities that drive the international and secondly to prepare for emerging threats because we are not quite sure what that is going to be in the future so we need that flexibility. At Los Alamos one of the hallmarks has been the free and open exchange of unclassified information. We are operated by the University of dals California and that sort of academic freedom of expression is something at the very core of our ability to excel in carrying out our missions. So my own background is in nuclear physics. The majority of the research is unclassified. Certain aspects of it do get into dual use. In particular some of the cross Sections that we measure which are relevant to issues in nuclear weapons are also directly relevant to nuclear Astrofy sicks issues. The center of the star is about the closest thing that simulates the environment environment when a nuclear weapon detonates. The mix and match of those two has been a continuing issue in terms of how we deal with the security issues and more and more we are responding to the needs in the area of homeland defense. And so some of the technologies that we have developed in my old field of research which has been physics has carried over now in taking those technologies over into homeland defense by developing new capabilities in low background detection and this is of particular relevance in trying to detect the entry of I will illicit nuclear materials into the United States. In the WAN item information sairia we have a growing effort that this. This is something that grew out of just the interest of a relatively few staff at Los Alamos in the early 1990s. This was an effort in a group that I was leading in the mid 90s when I decided that we needed to invest institutional resources in and so we funded the first demonstration of long distance quantum Corpus Christi Graphy efforts -- cryptography efforts and this is again an area in which dual use is reel vapt. Originally cryptology was a means to provide secure information transmix one in which under fundamental quantum mechanical principles you cannot break into the sills temperature without being detected. Absolutely physically impossible to corrupt the flow of information in a way which is undeteched but then of course, if became obvious that this is relevant to people trying to protect information of any type. People in financial and banking institutions and so on who need to transmit information back and forth from different occasions across the country in an absolutely secure manner have gotten extremely interested in this. Quantum computation is an area directly allied with this and again the issues here range from entirely new evolution in computer science to the ability to factor large numbers which is absolutely critical in terms of breaking codes. Potentially quantum computation provides the possibility of breaking a code in the few minutes which under our current supercomputer capabilities would take years to do. Could SO? I wanted to point out some of the issues relevant in these different cases. You do have to deal with two types of information. The first is just purely data information which comes out of experimentation and theory and the second is those techniques and equipment that have dual use applications and how you approach these is some what different. In both cases dual use is something which the laboratory has used to advantage and we're very careful when it goes over from dual use to single use. Spore example, in -- for example, in nuclear physics it is not the data itself which is restricted but as soon as you Mary the data with the models that simulate the performance of a nuclear weapons system then it becomes classified information. In homeland defense it is not the techniques, it is not the necessary capabilities, it is the specific sensitivities to detection and how we deploy those and our capability to threats which is restricted. In quantum cryptography it is the application of specific cases and many deal with specific cations in the intelligence community and we take a greater approach to this so there are different classification levels imposed pontiff rent types -- upon different types of information. And in the quantum cryptography a lot of that goes into the FBI, the secret compartment information category which there are only a few hundred people in the laboratory out of the 12,000 employees who have access to that kind of information. We are a scientific organization. We publish a very large number of publications. We have about 1800 open published peer review publication journals a year coming out of the information at Los Alamos. Handling that flow of information has become a challenge. We developed two ways of doing that. Research from the varying depth peer review in terms of classification and this is under DUSA designated unclassified research areas. This is a system in which we propose to be in NFAA certain areas which we say none of the information in this is of a classified nature, none of this is essential to national security. That process usually takes about 18 months to get approval so it is fairly rigorous but once it is in place you have a standing exemption and so you can simply publish by saying this falls under this particular DUSA. Secondly, for things it which don't fall into that Kathe are reviewed and approved for publication by what we call an authorized div derivative classifier. A person trained in looking at the classified informationish shies within a publication and every single thing that goes out of lass Los Alamos goes through this process. So my talk went through this process before I came here. One of the greatest challenges is not so much in publication because there you have products coming out and you are dealing with a specific item. It is in mail and e-mail communications. And in the electrickic age e-mail has turned out to be a tremendous susceptible to security. At Los Alamos you are required to know what is classified and what isn't and you are required to renew that freezing raining to renew that training every year. If you are the least bit unsure you go and get somebody to check it, namely one of the ADCs and the people who work in the weapons program are required very specifically to attach, you know, on the end of each message saying this message was checked for classified information. We could that universally. We don't succeed 100%. Our failure rate is about 1 in 10 to the 7th. That is enough to drew tremendous -- to draw tremendous scrutiny from Congress on the laboratory. Something which you cannot entirely proceed without completely closing down the information. Some of the issues that arice. There are sort of three areas in which we had difficulties. One in which content was sent which simply should not have been sent. Is extremely rare. Secondly, classification level was incorrectly dermd. And third, and this is our biggest problem is that you will get a sequence of e-mails. Somebody gets an e-mail and respond to it and include the original message and keeps cascading through and while any individual part of it may not be classified when you take two or 24R50E three different pants suddenly -- parts suddenly ow are you are in classified territory. Improving or rejection or controlling the loss of that information and this is where this culture of awareness is very important because it is basically impossible to provide the detailed guidance required for each and every message that you send out. Science is continuously evolving. The books are never up to date. There is always am ba Gaoitys so people have use an awareness of what they are sending out and think about it so say if I'm not sure I'm going to go check and there have been many cases where we have gone to people and they said ghee, we have never seen this one before so they go up another level to experts and ask for guidance. Is not unusual. The final one, how do you prevent this. Awareness is basically the only way you can do this. We looked at the process. It was suggested that we review every single piece of e-mail that goes out of 9 laboratory every day. The laboratory generates over 300,000 e-mail messages a day so our Chief Financial Officer assessed what the impact of dhoog was. Our estimated cost was $395 million a year to do that. I think that was clearly an unacceptable solution so we have backed off and gone to the culture of awareness, providing guidance, making sure that people are careful. Then there are issues of communications win groups and outside of groups. Within groups we have a mix of people some of whom are cleared and some uncleared. We have foreign nationals. One of the hallmarks of Los Alamos is our foreign national population. We have 540 permanent staff at the laboratory who are foreign nationals. That is always raised as an irn issue but as long as you have this awareness of what you are discussing you stop and think wait a minute am I getting into an area which I don't want to discuss with this person generally that is not a problem. You get into more of an issue in terms of interactions with external groups because those people are generally unclassified. But this hasn't raised any significant concerns. We do require formal approval of collaborations. That is management wanting to know what is going on and what we are doing. There is a specific issue, though, however, when we deal with people from sensitive countries. Sentive countries are defined as those which present a particular threat to the United States. There is about 25 on the list of sensitive countries. North Korea. Iran. Are typical. Most of thetes have been put on the list because of concerns about nuclear technologies but some of it goes beyond that. One of the questions for the bioscience community is do you want to single out particular countries and the people from those countries as being a particular threat. Are you going to deal with people from those countries in a different manner than dealing with people from John sensitive country. By the way, Russia is a nonsensetive country these days. And finally, for information which you absolutely do have to reSt. restrict and you don't want this getting out into the public domain you have to provide the infrastructure in order to provide that communication because you can't just have ice lated -- isolated BSL3 facilities around the country not talking to each other jrjts generally using dual use technologies has not been an issue. There are number of cases where we have to provide special controls for a limited time while we go into limited experiments and the staff moves back and forth from behind the fence out into the open and quantum cryptography is more restricted because a lot of this deals with intelligence information. All of that has to be done inside of a skiff in which they have the specific facility with stringent access control where you do the work. So this automatically limits communication. I don't think this has been a fundamental problem at Los Alamos but there are issues associated with it. I think one of the greatest Los Alamos is the issue with communication with foreign nationals. So all communications that involve foreign nationals reporting requires oversight and security at Los Alamos. Every time we bring a foreign national in we have to get approval. Whether there for an hour or there working permanently. A statement of work. Who is going to over see the work. What access to computer systems they going to have and it is reviewed on a case-by-case basis every year to verify there was no loss of sensitive information or technology garths restrictions are becoming more and more stringent. We are facing issues now where our foreign nationals may not be allowed access to administrative information such as how much time and what vacation they have left and what their vacation accounts look like and the reason is because they are on one computer at the laboratory that contains other information they people are concerned about. Do you have an entirely redundant computer to deal with that? That's what we're still struggle with. The foreign nationals let the Iron felt the impact of this. They have difficulty in doing certain aspects of their job. They feel discriminated against. And, you know, that is just Sim imy a fact -- simply a fact of life that we live at at Los Alamos. One of our greatest security riskish issues facing national security is the restrictions that we put on foreign nationals. Not the fact that we have them there, the fact that we don't have enough of them. To address national security issues we need the best minds in the world deal wth issues. Not all those people are Americans. The laboratory was founded by people who were largely foreign nationals back during the Manhattan project. That statement received thunderous rejection from the DOE. Any don't want foreign nationals near any classified information. Every time there has been an issue it AFS U.S. sit citizen who had access to it. It was the insider.

Let me finish up with let's sons learned. I think the bioscience community has to deal with the increasing rigger being focused on national security issues. I think you have a much more challenging problem than we do in the nuclear arhea. In the if you nuclear arena to represent a nuclear threat you have to get your hands on special nuclear material and that generally is very well controlled and there is a limited amount of it available. That is not the case in bioscience. Dual use technology necessarily enagainers additional efforts. I don't see anyway that this community is going to get away without some sort of process of reviewing all pubcations and presentations. You may decide to do that by exemption or exception but I think you're going to have to have a process which deals with things across the board. The culture of awareness is absolutely critical and all of this takes time, money, resources which is going to divest -- be diverted from sigh entiff fiscal research. -- scientific research. Physical access is an issue. Have to decide what you are going to do about that and in particular in in community which is very much an international community what you are going to do about the question of foreign nationals having access to dual use information and technology is something which is actual critical. One vert lessons that we learned at Los Alamos is it would behoove you to form integrated teams between science and compliance personnel. At Los Alamos over the last 10-15 years the response was to put the compliance people in charge, have them develop a set of requirements, procedures and then just throw them over the transom without any thought what the Iron impact on cost or productivity was. It was more important to be compliant than to get the work done. So now everything which comes through the laboratory in terms of new rules and leg regulations gets checked for cost cost benefit, gets checked for impact on science and the best way to do this is to get both sides of the house talking together. The compliance people have a valid set of issues that they have to live with and the scientists have an equally valid set. Finding an acceptable overlap of those two is absolutely critical. Finally, I would just like to say that we have dealt with these questions at Los Alamos for the national defense for 50 years and I would like to offer the services of the laboratory in any way that you might find use envelope helping you to deal with these questions. Thank you.

Thanks, Tom. Next I'm he pleased to welcome Dr. Phil Cal bill, a director of the nature publishing group to share with his his perspectives as a member of the scientific publishing community. Dr. Campbell?

Thank you very much for the invitation to speak that the meeting. -- at this meeting. The typeO says that I'm giving the perspective of scientific and authors. We reject 75% of our authors so I'm sure they wouldn't want you to think I'm representing their view point. Something serious about the journal. I'm certainly only giving my view point. The journals such as science magazine, cell, and "Nature," we are all in competition with each other and sometimes that becomes an issue but on this issue I would say there has been a lot of collegiality and discussions and I'll give an example of that. My purpose here is briefly to to review history and provide an overview of some of the key issues as I see them. There was this meeting that has been referred to and I put that up as a point of reference. Those were the people at that meeting in January of 2003 following a national academy to get editors together to discuss thish issues, many of which are being discussed but you and I would say that there was a large degree of consensus during that discussion about the minimum amount of regulation that we could all accept. And also at that meeting were not only the editors and some of the authors of some of the more controversial papers published up to that time but also representers of government departments as you see on this slide and I would say that they were there to.

Help us regulate ourselves to adopt a culture of responsibility to use a phrase that has been used at this meeting. We were very aware that Congress were concerned about some of the pubcations which had recently appeared and we were therefore concerned [ Indiscernible ] to try and anticipate and if possible preempt any over reaching regulations. We came up with a big statement which you can find in the journals from that time. I just wanted to highlight one that took a bit of soul searching before we were willing to pit our names to it but there were circumstances where just for security easterns reasons we might not publish a paper and there was some controversy following that announcement. There was a letter in science saying that there needs to be a lot of clarification about just what it is that we might regulate, prevent ourselves from publishing voluntaryily and this issue is absolutely with this advisory board. There was a strong statement made on their own website by the public library of science which as many of you will know is a recently formed publishing group set up to promulgate open access pun publishing paid for by the author rather than the subscribers so available free of charge on the internet. They took a strong line that any such control was Akin to censorship. And then if you look around you have people have that concerns about openness and I just mentioned two people here and I won't goo go into what you say. But they are people about who if you want to get the most skeptical view about what journals should be free to publish that would be a place to start. We have a group offed a advisers with defense including in Britain and in the U.S. at some of the national labs we held informal discussions with people about how they should work best and set up an internal framework for consultation and published the policy and it is very straightforward. We maintain a network of advisers specifically for biosecurity issues and when there is a Paper that comes in where an editor spots a potential problem that is shared with me and with a couple of people within the editorial group. We have [ Indiscernible ] itself as part of this -- we have "Nature" itself but we have a lot ?F a lot of spinoffs such as [ Indiscernible ]. And then once a decision has been reached authors will be informed if your security advice has informed that decision. So so far so good. Having talked about that policy in various places a number of questions do get asked and I can't say thaim' necessarily -- that I'm necessarily satisfied with the answers I give. One question that was asked is why keep the security advisers advice confy depletion. It confidential. It is even arguable that referees Hud shouldn't be anonymous. The practical reason why we keep the security people anonymous is because for two reasons I would say first it would be a cultural leap to announce their identities and secondly also they are also often times giving us technical advice. We did get feedback from one of the papers that we published saying this policy needs to be more transparent and openly regulated or maintained rather. What happens with a paper rejektd on security -- rejected on security grounds and this is a definite issue for the cmiet tee to think about. There is no system in place or agreement in place which which if we reject a trouble some paper purely for security reasons we will then do anything to prevent it from being published by any other journal. At the moment we would in -- [ Indiscernible ] of course, we can exert our discretion so that applies not only to this. Would apply to an episode of pronexal misconduct. We do try to act responsible if the need arise. If there is this agreement that we all reached or consensus is a better word of how we would act is, that international, does it include foreign language journals. The answer is no, it is not very international. There are a couple of publishers from outside of the U.S. represented but it is not being straight ahead spread as a consensus statement. And what actual questions do we ask the security reviews and on the whole we have been understanding that the papers we would turn down are not obvious [ Indiscernible ]. Give than we don't usually handle those sort of papers it is not obvious that we come up with a menu of things for the referees to look out for so we simply ask them the general question. So what has happen the in practice and before giving this talk I checked with John Kennedy of science and Sam Kaplan at the ASM and [ Indiscernible ] at the NAS. To the journals we sent out several papers during the year during which that agreement was reached but no decision has been affected by NSABB biosecurity contribution. Similarly, the same applies to "science" magazine. These figures are imprecise and if you pre[ Indiscernible ] but as far as I understand it none of these -- none of these American society of microbiology papers submitted to the journals have been rejected for purely security reasons. I also included the statistics that somebody gave me which is very similar to what we have as well that most papers now are coauthored in our experience by five people on average. Sometimes you have a huge number of people, sometimes it is only one. But on average 5 5-6 people seem to be an average and in the ASM 60% of them include multinational partnerships. And then [ Indiscernible ] until recently was in a similar situation until the recent exception. So there seems to be general consensus that is emerging through the years since we had that discussion with open pubably cation is the key to public health but details of -- on [ Indiscernible ] that kill many worldwide are worth the Rick. Probably contained experiments and appropriate facilities are crucial and public outraech outreach and education are crucial to avoid misunderstandings and appropriate regulation. One or two general statements which go over a lot of what has been said and I will skip most of this because it has all been said. Certainly you can demonstrate the fact that you have have immediate health benefits by push publishing some of this stuff. The benefit of economic health. The openness of attracting talent and openness encouraging national collaboration. You also get a sense of consensus internationally that is one of the virtues of the internationalism of science so you can get international activities leading to a con consensus in what con city stiewkses appropriate action as you seem to have seen with Iraq. [ Indiscernible ] for scientists to move research programs elsewhere and, of course, we have seen that with stem cell cells moving from the U.S. to other countries. I think there is a key issue of trust and this has been referred to already. The perception of the U.S. in particular at this time. There is no question that editors outside the U.S. and scientists will bewarery be weary about the U.S. motive yaks. Led to a chilling of the climate and we are all aware that. So key information resources that everybody depended upon generously bestowed by us in the U.S. is an example of that are ultimate ultimately under some sort of government control so there is concern about what might happen if people got concerned about some of the papers appearing on that. Another question that came up at the meeting we had and still waiting for a good answer is this it. What are the its that would stop us from publishing these papers and I will refer here to a Paper in the Johnal journal of health Homeland Security. By Ray Zielinski, a Monica Tucker who work at itch city tubes for institute for international studies and these are just a set of six types of work about which one needs to have concern. I certainly won't talk to them. If you look carefully you will see differences between those and the [ Indiscernible ] which which I will refer to later. I will put this on the agenda as to another source of information that we also might think about. I also wanted to highlight points made by George Post how many people will know at the academy meeting itself in 2003 which talks about not only the obvious weaponry that we all have discussed today but also highlighted other area of research which we need to be aware of in the past -- or in the future. Delivered engineering ever immune escape and the over production of host inflammatory mediators, the knocking out of Genes that regulate see cell processes, small molecules that [ Indiscernible ] blot clotting ace systems and so on and more mechanical disruption and a lot of these areas that at the most exciting end of research so there is definitely dual use in other areas of microbiology for example. We also had the think recommendations which we have seen before so I won't go into those. Since that meeting we have published and other neurosurgeonals have pub -- journals have published papers which were in many cases totally uncontentious. They were shown to security experts and I wanted to high highlight those as the sort of papers coming out all the time and I can't resist mentioning quite by chance that the person I chose to quote making clear the virtues of the publication of the anthrax genome is a member of this committee. I couldn't have known that until yesterday. In fact, I got the slide together some time ago. That made it clear that publishing that genome had a definite benefit. We did get feedback from another Paper that we published on the vire rue virulentence of flu. There was an insight on what was going on. The bottom line was that is showed the origination of [ Indiscernible ] twi was in relation to the safe tiff of the lab's concern as to why do the work at all and a concern over transparency and Democratic accountability. I feel that we were right to push rich that paper. Then we come to something that has been referred to and is in the news at the moment, this paper sub mutted to the national -- submitted to the national academy of sciences, the proceedings of that institution and concerns the introduction of the theoretical study of the impact of body line toxin into the milk supply into the United States. And just to discuss what the paper does, it says impress, in fact -- in press, it is now published online. The Interpublicin put was to take various is a scenarios of toxin introduction. And it proan out put that range of impacts on health and mortality and responses to protective measuresion highlighting security needs but then there was a course of events worth summarizing because it gives rise to issues which which I will quickly summarize in term. Checked with HHS. HHS denies. The author denies that he got that response from the HHS. I'll come back to that. [ Indiscernible ] followed all the procedures that they said they would follow. The referees all aprorved publication of the napier. paper. They press released andish shewed in in embargo form to a journalist and a journalist con tacked the HHS and asked for the reaction to that that was going to be push riched and they contacted the national academy of sciences to express the concern that they originally expressed to the author. The national academy decided to delay the publication and had a discussion meeting and proceeded to publish it and you find a full description of that order of events in an editorial by Bruce ail, the President of the [ Indiscernible ]. Races some issues. One is there is responsibility of researches and the HHS and other agencies to pursue an alert like that in a way that is fairly rigorous and robust. Because, okay, we have this in this particular case a difference of description of what happened and who did or did not get back to who and that in itself is unfortunate but the question is what is there in place any way to researchers who are acting responsible.

responsibly on their own initiative once they have done a piece of work that they consider to be sensitive. I would say it is straightforward for this nightee to address -- committee to address. There is a question which is whether the paper should have been submitted to a high profile journal which the PNAS is and whether that journal should is accepted it. I'm not going to try and act in Nick [ Indiscernible ] place and make a judgment on that point because I haven't seen the referee's comments. I do think that is an issue whether that sort of paper is appropriate for that particular journal. Then there is the question what is the sensitive research. How should the government responsibility. What is the' proip patriot [ Indiscernible ] for communicating results. There is a lack of guide out there and I think from what I heard about about the conversation that took place between the government representatives and NAS there was an over reaching negativity about the idea of publishing any such paper could have as I Sabo over reaching and without better guidelines it seems to me such discussions are undermined. To there I think this board have a very [ Indiscernible ] to pay. I won't go -- a very key role to play. In another area of interest to this board which is synthetic biology. This is an example many of of synthetic genome mixes that we push published. It is A, important. B, rapidly turning out to be a cheap sort of top net technology that could be widely available gi did I did want to dwell a little bit on synthetic biology and some of the issues that it races for journals and the community. Here is a description from one of the Pioneers of the discipline drew at MI tismd. Written by Oliver Morton in wired magazine which you can find online in January of 2005 and basically describing a program by which one can assemble a set of parts and buy gin to make Art fix chromosomes and replicating organisms which don't follow the [ Indiscernible ] as it were of maturely see evolved original organisms. Engineering as well as science. DNA bashing. Knocking out Genes and seeing what happens. The focus is on the Art fix production. It as methods sort of type activity so there are methods journals out there who have different criteria from scientific journals in the sense that there isn't any insight coming out of this work and it is more like the technology. The cost productions issue I have mentioned. You get into questions of should there be registration of the equipment that these people are using. Is there a need for engagement with security communities and stake holders to which the answer seem toses to be yes,, yes. Is a [ Indiscernible ] moratorium practical the answer seems to me is definitely not. In relation to the code ?T of conducts because it is potentially an engineering community and still a small community they recognize that they themselves can moderate or think about their behavior in the context of the issues that this pured -- board will deal with because engineers like medics are more Akin, more used to the idea of codes of conduct and those codes of conduct which is bite and can lose your license to practice. Although this is founded in in institutions which don't have that strong tradition nevertheless any themselves recognize that this is something that may be necessary. I think the final pint is also important. -- point is also important. It is not materials that come out of this work that is spreading around the world. It is information that you can easily post on databases. I think compliance is one of the last things way tonight talk about. You have in universities well established frame works for compliance for safefy regulations and research involving humans and animals and less well established for other codes of practice so I think that is an issue. The same applies to journals. We have well established codes of conduct. The journals themself insisting on the sharing of materials and conditions that we have to publish about whether guidelines are being followed on ethical issues to do the research on humans so we have far less systematic guidelines for ethical boundaries. We have no frame work to provide security concerns. Finally come on to the [ Indiscernible ] processes that one might alert one to. And huer I'm going to -- here gaming to flick quickly through several publications appeared or presentations that happened recently. This paper I already refeared to. The Paper that has just come out in the CDW conventions bulletin by [ Indiscernible ] and jaundice disand this I think is -- John [ Indiscernible ] and this is worth thinking about because it goes up to the international level where you have [ Indiscernible ] to the top and then Iraq type at the frame arc and then the other arrangements. There are an exercise that I won't go into. I'm sorry, time has gone on. I won't go into it but again this was an exercise done by the University of Maryland where they got together a group of people, five scientists proposing studies and peer review to look at the proposals and see what sort of consensus might emerge in judging the risk and seemed to the organizers that you could get some sort of a consensus and there was clear criteria that emerged so this board may want to think of organizing some such! Er size again. But there are these problems on restrictions and I think almost all of these have been mentioned already except as far as journals are concerned although make sure and -- "Nature" and science and other journals have got a lot of resources behind them most journals do not have a lot of resources behind them and issues of compliance and process that you may want to impose on them or recommend to them is not obvious that that hele always be able to do them if they take any resources to -- to get underway. So I just wanted to end with what I call key truisms which is the journal editors must show responsibility and I hope I'm showing in some ways we already are but we are absolutely open to further discussion about what else we must do. As has been said here already scientists must show responsibility themselves and I want to include my favorite quote which came out of cangsal testimony, the traditions and structure of research depends on reputation and [ Indiscernible ] to allow that must be published in peer reviewed journals. Such also mitigates fraud you lent results, sloppy science and political [ Indiscernible ] guiding important policy decisions. Recent well publicized misconduct underscore the merits of this system.

Thank you, Phil. So we will go ahead and move on to the next speaker. As is obvious from many of the talks today the issues Sur surrounding dual use research transcend our borders. We will now hear from Ms. One did Wendy White the director of the board on international scientific organizations at the national academy of sciences. She will give an overview of international discussions concerning dual use research.

Thank you very much. It as Le shower pleasure to be here and see you all still here. One of the advantages of going last is I get to be highly select Ivl onive on which Slides I show you and which I think you have already seen. There has been some discussion already about the need to internationalize this debate and I have been asked to concentrate on that issue. I'm going to tell you a little bit about an national forum on biosecurity that recently took place in Italy in march of 2005. This meeting was cosponsored by the national council for science, the international or the interacademy panel which is a network of 100 academies of sciences from around the world, the interakakmy medical panel and the national academy of sciences. We had scientists from more that the 20 countries at this meeting from both the north and south. I think the thirst people who signed up were from Mongolia but we had Zimbabwe, Brazil, south Africa, China that and so forth. The forum divided itself into three working groups. One discussed guidelines and principles for professional conduct. Dissem nation and communication of research which is the one I was in and will focus on and codes of conduct and there are many people in this audience who were at this meeting and I would invite them in the question and answer session to add anything they want from their working groups. The forum was a direct response to the think committee report and its agenda reflected the growing awareness that this are rapid developments in life sciences and biomedical research. Many of this debite we have debate we have already seen today. We intended to broaden the debate and enhance the aware mns of the issues in the national community and so some it served as a nagger convening major major con convening organization. A number of the participants at the Como forum also participated or will par tais participate as invited experts to the BWC con investigation. The overall meeting outcome is simple. It was the first time many have seriously considered the implications of dual use but all were convinced at the end of the meeting that they as individuals and the scientific community as a whole has a major and pressing responsibility in this area. The working group that I participated in was specifically on dissem nation and communication of research and our group started by looking at this principle of universality of science. A lot as been discussed today in parts or different parts. I put it here on one slide this is what the principle states and what scientists are talking about when they say or referring to the universality prifn. The freedom and conduct of science and covers three critical area. The freedom to pursue science and publish the results. The freedom to commune communicate among the scientists and the freedom of movement of scientific materials. This principle has been stated by the international counsel for science which was a sponsor of our meeting.

Without regard to such factors at citizenship, reLidge gun, creed, political stance, ethnic, or rain. Raise, color, SEC Securities and Exchange sex and gender. The universality has been challenged in the last number of years. But the -- because the intrinsic nature of science is universal its success does depend on cooperation, interaxe and exchange that often goes beyond natural boundaries. For this reason scientists must have open access to each other and to scientific data and information. The changing political climate and concerns about international terrorism have challenged this principle. Threatened boycotts on scientists from other countries. Restrictions on pub publications in ex-chace of materials and withholding of travel visas, something of which I'm very familiar are just a fiewf the challenges and the restrictions can have a negative impact on the overall value of science nationally and internationally. The second issue that might working group focused on was the changing nature of scientific publishing. We have heard a lot about this already today. But researchers face increasing pressures to publish faster and in more internationally accessible media. AnyThey work in environments dominated by web-based publishing. I read this morning that by the year 2020, 90% of newly published works will be in electronic form and only about 50% of that will we be available in print as well as electronic. And in our group also discussed the vast growth of international science. The number of authors from more than one country increased 200% since 1981. International collaboration accounts for one third of all coauthored articles. Is probably low. That means there is almost a guarantee that every biomedical article written will be push published some where some time by someone. Controlling this environment is extremely difficult if not impossible. It is not enough to focus on the U.S. environment. I would refer some of you to what I think would be an interesting case study on KEMRON which was the cure for AIDS announced in 1990. Focus on traditional outlets is also not enough. Information is widely and in standly available on the internet, preprint servers, textbooks, web pages, institutional depositories, backlogs blogs and many other peer reviewed publications. Our participants in Zimbabwe started with this and I think it is rather interesting where he sees what the real challenge is is not -- is that if -- if we try to control information too much then his country would have a hard time doing the research it needs to tackle AIDS and HIV. We also had one participant who consulted with her south American colleagues and asked them to what extent they were aware of these problems and found that to a large! largeextent most of the people she talked to were not even aware of the dual use issue and cited a lack of adequate legal national framework to control dual use biological agent ?T and related research. She pointed out, too, that the rigor in science is some what less in some of these country. There are fewer peer reviewed pubcations and less of an awareness of the responsibility needed in life sciences. Her response and she suggested to us that we encourage international programs that raise the awareness of scientists around the world of these issues that increase their capacity to deal with these issues, that help them identify experts who might come and help. Help them address concerns of policymakers and officials and help build networks to disseminate the kind of information needed. So we will move on to that Como work group conclusion. And to a large extent our working group conclusions echoed the findings of the January 2003 meeting at the NAS which Dr. Campbell has just thoroughly described. We made a distinction between fundmental and applied research. And in the end all of the researchers in our group recognized that sensitive information does exist but efforts to control the dissemination of such information at the Ind sted re-- at the end of the research change at the publications stage are neither desirable nor practical. Once something is peer reviewed or published or online it is far to late then to control. Our working group also found that the benefits of increasing access to information and openness in science are enormous. You heard that over and over again today and the scientific pros sec works only in an open environment in which research results are built upon. You heard that over and over again today. There AFS ftc a there was a quote in the Washington post on Sunday and summarizes with our working group thought. The best defense against those who would use it -- referring to information -- as a weapon is to ensure that our own scientists have better information. This means encouraging publication. Researchers must address public issues by taking responsibility for the knowledge they generate. Our group concluded that the shared ownership of knowledge is often a better safeguard than restricted access but we agreed that researchers could do a better job of informing communities of the universality of science and that is how you find me if you want. Thank you very much.

Thank you, Wendy. So that the point we move into the -- at this point we move into the discussion with the board and ex officio members. I would like to thank the speakers and ask you to return to the podium, please. I would like to remind the members to use your my microphones. Sometimes during the previous discussion when individuals would turn their mouths atollway from the microphones people in the back of the room weren't able to hear us so try to make sure that we use the microphones effectively. So with that I would open up -- with that I would open up the floor to any discussion.

Harvey?

I would like to ask about the activities at Los Alamos. It seems to me that is a relatively unique operation and many of us come from universities where we don't have that kind of infrastructure that you have. Do you have any thoughts on [ Indiscernible ] tests of control that universities would be able to [ Indiscernible ] given the different nature of the [ Indiscernible ]?

It is certainly a challenge because the laboratory has invested significantly in the resources, the infrastructure to do that. But I would say the thing which is common across all of these things is that any system that you put in place is going to fail if the people who are involved in it have not bought into it who are not aware, who are not going to participate in it and a lot of these issues our first line of defense, you know, against uninintentional release of information is the staff itself. And I think at the National Laboratories there has been this issue which spans, you know, the entire spectrum of activities where people are [ Indiscernible ] with the need to think about what you are doing. To be careful and be aware and be accountable and you don't normally find that to the same ebbs debt at the universities universities -- extent at universities. A lot of this is going to be an education process in getting the faculty and stew tents at the universities to be aware that this is an issue and it affects them and the people around them and they need to participate in this.

If there isn't the infrastructure at the universities from your perspective in the fies physics commune community, have they been things published from universities that you think are major -- major risks and tis [ Indiscernible ]?

Not specifically. What does happen is that we -- we have seen cases in which there is a low level of concern in which people have just on their own put together information which any one part of it by itself is nonclassified or nonsensetive but when you pet it together it actually is -- put it together it is sensitive. One of the dilemmas we found ourselves in is how do you communicate that. Because it is a security violation to tell somebody that that is classified so you know it is the old catch 22.

So if you continue to the the line of logic then the vast history much longer than [ Indiscernible ] it has not been a publication that has resulted in something that would be considered a security, maybe we don't need this big infrastructure at all.

Well, that is -- I mean that is a very good question. The aspect of it which I think you are going have to deal with in particular is the international aspect in terms of countries in which we know there are organizations which may want to threaten the United States. And in which the governments are not acting in a responsible way to bell qwell those groups so do you somehow single out certain area and try retrick strict, you know, their par participation and efforts. This cannot be a European lat unilateral approach. If the United States decides we are not dwg to get anybody from -- going to let anybody from country X come in and have access to the technology or information and we are not going to allow students from the countries to enroll in the universities here the only way that that will be effective is if the entire international community buys into that. And so how you deal with that issue is -- is very, very difficult. It is very different in the nuclear arena because here we are dealing with a limited set of countries which have nuclear capabilities. And a limited set of technologies which are, you any, very specifically a threat to international peace. The problems that you face in bioscience are much more ubiquitous so I don't think the sew luxes solutions we applied in the nuclear arena apply no in the biotechology arena.

Faculty members are sending autonomous agents some of whom report directly to God and then some report to beings and department chairs and ultimately the President of the university and so to try to imagine a President just to take a random example suggesting that we structure apparatus es that would be analogous to those in federal laboratories is -- is difficult to imagine. I -- I envy you the ability to have that kind of cohere rens about the thinks that are important and things that are less important.

Let me just respond to that. You obviously have not been to Los Alamos.

Wasn't going to make any derogatory comments about recent problem.

But part of the issue about problems and so on is what culture do you have and one vert great strengths of Los Alamos has been the individuality and open academic freedom that our staff have enjoyed and there is continuing pressure to clamp down on that and the laboratory is trying to find a balance between maintaining the creativity and best intellectual atmosphere to retain our best staff so that we can address these issues as the same time as we are being compliant and at the universities I sit on the council in research the the University of California which is the chancellors of research and their counter parts of the three UC lab and the universities are being forced to address some of these issues. For example, dual use export conditions. That has been a major topic for discussion at the council on research because you by law are compelled to make sure that you are not transferring, you know, sensitive technologies to foreign nationals without due controls and so there has been a lot of resistance at the UC campuses about what that means and how you implement it and that was why my last point I think have very important that you need to work with the controllers, with the compliance people to Figure out how grow you are going to implement some of these conditions. This committee of the NSABB is going to come up with a set of suggestions, recommendations, policies that will address some of these issues. However, how those are implemented and how they affect your institutions back home is a separate question. And if in your deliberations you take that into account, you know, you will be much more effective in being able to translate what your decisions are here into how it impacts people in daily "Life."

life.

And I want to make sure that I salute you for the courageousness of the cmenlts comments that you made and salute you for the comments in that respect. Sometimes trying to organize scientists around common themes and common code of conduct is like hearing calves. It is difficult. And that kind of aah tonmy is valued in -- aah autonomy is valued.

I think that the -- the presentations in this last session are extremely interesting inlytheir.

That intheir.

That jukt position and kind of the cull culture differences between some kinds of science and others and the kinds of nuclear physics science that doctor Bowles presents and nature of the biological sciences today and into the future and I'm struck by how different and maybe in many ways almost nonap pli cable some of the practices and rules and kinds of procedures are that were first described in the realm of nuclear physics and then finally, by the very different view of the future that Wendy White presented in which it seems almost in everybody visitable that biological information in its eye dye versity diversity and ubiquity and ease of digitalization will become widely disseminated in an electronic format in a web based manner and you you can see that technology will be distributed as bits. Not oonl in terms of procedures and steps and methods and insiebts and so sights and so forth but about biological agents. I ef the waves of synthetic biology. I guess that leaves me to wonder whether we can think about ways in which the biological community can self-organize in a web-like manner to see where it can come together that -- by the bits can come together that have, you know, potentially greater levels of potential harm and untoward effect than might the general, you know, realm of all biological information on the web do otherwise. In other words, is there something special about stories like publications that will still exist in the few future that we can still monitor somehow in electronic format as perhaps journals become less relevant but still package stories to maintain their relevance in biology.

Following up on that, I'm also struck by the -- by the -- I mean I think the nuclear experience is very important for us to consider as something that has been implemented and exists. With you then if you step back and look at the differences and the differences are so huge. On one hand nuclear weapons are human made. Biological weapons exist. That is already an enormous difference. One of them requires an infrastructure an industrial infrastructure. Requires materials. Requires a lot of things. The other one requires essentially very little and the realm on point -- these agents already exist in nature and in fact the greater threats I think that we face are the continuous emer against of emergences of these organisms as a threat to humanity.

Let me make a comment in response to both of those. I think you are absolutely right that there are very significant differences in how you approach the nuclear threat and how you approach the biothreat but one thing that it has in common in terms of openness of information, you know, after World War II there was a discussion about how do we restrict the information to make sure nobody else ever gets this information and the statement back from the science leaders, the ones who developed nuclear weapons during World War II is you can't do that. It is impossible. There are physical laws which people will go out and study and explore them and fiscal out how to do this.

this. The only way that you can respond to this is to stay ahead sted curve so -- stay ahead of the curve so that that our capabilities exceed those of any of our adversaries. I guy with -- I agree with that statement. The problem is that hasn't prevented the legislatures on imposing Fra Dr. dramatic restrictions on how we try to protect that information. There is going to be tremendous pressure from agencies, from Congress, from the public to put controls on this that will protect them and how you do that and how you respond to that pressure is going be extremely important.

Doctor,Dr. Bowles rightly pointed taught there is already a out that have a a regime in place dealing with biological materials and dual use materials that may have a military application and a broad definition of what falls under those rules and what requires a license or commodity jurisdiction request which is a program that ised a opinionstered which administered by the Department of Commerce and Department of State and there is a lot of comment going on related to what might be considered dual use technologies under ITAR, I was curious as to whether any of the members of the board have run up against that in terms of chill thairg ability to do -- chilling their ability to do research or restrictions on [ Indiscernible ]

It is a major and growing concern particularly when you realize if you ship something within th United States from a university and it is received by a foreign national it is a deemed export and a lot of people may not be aware of that.

Just having the foreign national work in the lab itself is a deemed Eck port. -- export. I'm surprised that the comment did not come up prior to this because this is already a restriction that exists on labs today.

It goes beyond foreign nationals identified from countries that are countries of interest or, however, you want to classify them. The whole issue of having post docs go back home and get back into the country is sometimes schilling right now. I mean it is a totally different atmosphere of the flow of foreign post d ocs who come in and out of the country or are here and go them and have to go through their own embassy to get back. Ha isin' an issue very per I pervasive in auk deem auk ceem ma.

If we are trying to establish a global culture of responsibility ensureing that that flow continues un impeded is a very important thing I think.

I agree with you completely and that is I think one of the first easy steps to do. Ob veeObviously not an issue in the person they get Kaw caught up in the beurre rock beurre recratcy. So there are a lot of people who get caught in the net. Making it I think from a morale standpoint having less thus enthusiasm about coming here to study.

I would like to make just a couple of comments about types of journals and journal publications and maybe Phil Campbell to expand on this a little bit. Journals like science and nature are very high end journals and as he said publish about 5% of the Papears papers submy wad lot of -- submitted. But a lot of other journals, unals of record or in my case journal of [ Indiscernible ] we publish a lot more papers that document the progress going on in virology. This is important because this documents the work that is being done by individuals for job security, for promotions, for tenure and whatever and so there is a whole aspect of the scientific enterprise that is involved in publications of this type that you don't want to mess with without thinking carefully through this. The second thing is that many journals sh the ASM journals in particular have a set of requirements for authors that again lead to the way that we do science. For example, if you publish in an ASM journal you are required to make all of the reagents that you have published available to anybody who asks so that the work can be repeated and I must say that one of the jobs as -- that I run into that is distasteful is trying to force people to do this when they decide that they don't want to do it because of competition or whatever. But basically again the whole idea of publication had impli cakes to how -- implications to how science gets done and it is key to me that thent enterprise relies on the whole way that the enterprise works.

Okay. I referred to one skeptic about openness Richard Mayer of the center for disease control. I don't know him, I just saw a document by him on the web which expressed specifically concern about exactly that, the sharing of materials. So although I agree with everything you have said, this is no question that that is essential for the progress of science. Nevertheless, there are voices out there who see this as an issue.

I have an implementation question for Dr. Reppy. I'm curious about why the think report recommended that the institutionally based IBCs are the first site to initiate the review of science funded protocols for risk of dual purpose? Why not a more centralized group like the RAC?

Well, let me say I'm speaking just on my own behalf. The committee had many members and some of them might have a different view of why we did that. I think the argument that was per persuasive was that, first of all, if you thought about the cost to institutions there had to be a local portal that you couldn't centralize it in the sense of saying send everything to Washington and have them look at it. And semiconductorly, that all -- and secondly that although recognized that the IBCs where they are functioning may be already working about [ Indiscernible ] it is fair to ask people to do on a vol voluntary basis because these are your koel colleagues after all doing this work but at the same time to say we have a have a parallel system and make people run through both of them seemed less efficient. I guess I would say and this is my personal opinion that we put this out with the suggestion with the hopes that the resources that the IBCs would need to do the job right would come from the recognition of how important the job is.

Thank.

It was also a question of practicalality. It would be logistically almost impossible to have everything get referred to a Sen central group. That is what we discussed what the role of the NSABB should be. Should we handle everything that comes in or should we set principles for the institutional review boards that would -- or excuse me institutional biosafety and it was that is should be done locally and logistics would man Tate that.

Aagree with that, Tony. I'm wondering, though, the principles that are set forth by this group then have to be sufficiently film or robust so that they -- firm or robust so that they can be applied across IBCs at all the institutions. Those who have significant resources, those have ho have none. Those who are really experienced with research, those who have less experience.

Although I -- although I -- when you think about that, it makes sense in principle I would ask the committee to also consider what has happened in clinical research where you could argue that the stringencies of the IRB process is basically slowing down clinical research to the point that we may now be at the part of the curve where the regulation is beginning to really hinder progress and that you -- for the amount of science that we have and the amount of new products they their availability of reaching patients is disproportionately slow to the availability because the capacity is being strangled through the regulations in my opinion of clinical research. Currently you have a very efficient process in -- it is still in basic science and as you put in the systems it will -- it -- it is going to -- it is going -- it -- it has the potential for basically seeing what we see in clinical research and the I can tell you as a clinician it is very, very hard to move things to the clinical research in the environment especially with the HIPPA act and the other act ?T on the ability to translate products into useful therapies.

I guess I would also point out that recombinant DNA there are specific guidelines and a lot of research is exempted early on because of these, you know, very detailed guidelines. I think that is probably true in the clinical arena. We don't have anything like that in a arena yet at least.

At the risk of getting into tomorrow MS discussion a little bit -- tomorrow's discussion a little bit about codes of conduct one cht aspects here that -- one vert of the aspects here that we may not have payed a whole lot of attention to is the select agent rule. It has struck me that Mable one vert jut comes maybe unintended of the select agent rule is that there is a very keen awareness on the part of the scientists of the seriousness of the materials that they have in their possession and I had soon a complete change at least at CDC, I don't know about in other areas, where the scientists really are very protective of their work and I think this is probably starting down a road that -- that this board could probably enhance.

Since the topic is communications and I -- I wanted to overlap it a little since Tony and one did I are there in terms -- and Wendy are there in terms of what are we doing proactively to get the international scientific community aware of what is going on here and what will go forward? Because I think that the more they are aware of the activities of the board and that would be a communication issue the better we will be in understanding the task of making this an international effort and so I just wondered we should have learned by RAC who are the groups, I would assume they are the same but what can we do and what should we be doing toen sure that we get the most from our efforts internationally.

It is an excellent question and that will occur but I think what we have to do is first understand ourselves what we are doing. One of the risks are going out internationally saying we have this NSABB and these are the kind of things we want to do and our colleagues internationally as they almost certainly will do is ask for the kinds of fleshing out details of what we are going be doing and I think it is important to at least get some firm understanding and agreement of the broad strokes of the recommendations and the kinds of activities we will be involved in and then to get the international community Iron embraced with us rather than going out essentially in a very fuzzy way.

I do agree. I'm just wondering what is our base in terms of knowledge of the international groups that will eventually be pulled?

Again, I can't give you a chapter and verse of maybe Amy does but I would think, first of all, the national sew stities and international academies is a very good place to start which is as you say that ground has already been sowed with Iraq. That is the most logical way to go. There are certainly others but I think that is a good start.

I tried to answer your question and not -- there are several levels of international dmiewnity out there and our European -- community out there and our European colleagues may be some what more organized to work with a board like this. Many of our developing scientists don't have any of the infrastructure needed to really respond and there we need to work through the international organizations already set up. The interacademy panel which has a reach of 1 awn1 academies of science pd across the world. They are all positioned to reach into the developing world.

I think although I'm perhaps gilty of it ourself that we shouldn't Romanty size the history of RAC so much. It wasn't as if you waived a magic wand and had it [ Indiscernible ] in connection with something else that I was writing I went back and read some of the contemporary reports of people and what happened and there was obviously one hell of an argument and I think that went on for quite awhile and then closure was reached and now we have this sort of myth of how wonderful RAC is. I mean we adopted it as a model which works but I don't think we should just to repeat myself we shouldn't underestimate the amount of work that went into that model and I think you have to expect that you will have to do that kind of work your solvesselves for this.

I have to agree with several of the points that have been made in terms of international outreach. At this point it is important that a plan is made, there is a co-hey serve plan wof -- cohesive plan. At the same time I think they are all waiting to hear what the U.S. does have to say and what the U.S. can contribute. For example, recently the NSABB was presented at the biological weapons experts convention meeting and all of the participants were quite intrigued by the idea of what we were doing in the U.S. so I think there is international support but at the same time it has already been mentioned and whether it should be that this group actually should be thinking about international strategies both at an informal level through connections in scientific communities but also consider how members here on this panel for example such as the State Department can help facilitate reaching out to your international colleagues whether in multilateral forum or bilateral agreements and such so that this something you should be thinking about as you move forward in planning in how to communicate dual use research to our international colleagues.

David?

I had a question for Tony Fauci. I think the notion of a culture of responsibility is so fundamentally important and a large amount of our discussion so far as focused on a top down approach but I know as you know very well, it must also go bottom up from the grass roots and as a working scientist yourself do you have some thoughts about how to win the hearts and minds of the community, many of which may have at this point some degree of skepticism about the nature of that kind of endeavor?

I have some ideas, I don't know whether they would work or not. I think, first of all, we need to not come out with pronouncements without vetting it out carefully in the community. We have been given the official members have been given the responsibility to come up with recommendations and that will happen but I think there needs to be a lot of discussion at the level be they workships or what have you -- workshops or what have you so that people understand what it is that is happening. As you all know, weeing part of the scientific community, David, that one thing that people in academics don't like is Dick takes Dick dictation from above of what they do. The other thing is the issue of threaten. There is a lot of anxiety about issues that they may -- I mean I was a little chilled by your presentation [ laughter ] you took -- it was mentioning about hurting cats, could you imagine in a biological system academic setting to have an e-mail checked by somebody I think that would be the end of that very quickly. So what I would say is that we would probably need to be very transparent about where we are going as we are getting information because we really don't want to have a situation where any feel threatened in their independence, threatened in their ability to pursue their own academic pursuits. We have got to make that very, very clear and that I think is inherent to the concept of a culture of responsibility. The culture of responsibility presupposes that you going to act on your own and be your own person in the pursuit of knowledge and ?R and that is why you need the responsibility so I think we need to keep hammering that in.

I just wanted to respond to several comments brought up about the need for this committee to think about the dual use issue in an international way. And as it has been previously mentioned by the chair, we will be forming among our five subcommittees one of them is devoted precisely to that, that thinking about -- to thinking about the international landscape to promote strategies for international collaboration. And one of the first tasks at that sub dmitee will be to -- subcommittee will be to look at a full inventory of the activities already underway and beginning globally so we appreciate your comments and take them to heart.

Phil commented earlier on the lack of an interjournal mechanism for coordination on security issues and I wonder if you could expand on that a couple of sentences? Is it useful? Is it practical?

Just you mean increased collaboration between journals for?

I think if I understood your comments with respect to certainly review issue.

Yeah.

There was no way to pass that among journals or coordinate among journals.

Right.

Would that be useful or would it in fact be practical?

I think if you had a situation where the paper had been rejected for reasons that were purely for security reasons and you had a feeling that this could well be submitted to other journals of the same I willing ilk you could tell a few people but having a list of all in the world would be impractical. So I do have a problem with that eye tee. eye idea.

Just to make a comment in general. I think it is absolutely critical that because this is the end national board that we have a buyin from our colleagues throughout the whole research sector. If we don't, I don't -- I don't think we're going to succeed. And I know there is skepticism out there right now because it is, again, the government and I think we need to make our colleagues as I think we are going to do a part of the process. And have a buyin nationally and ultimately internationally.

I was thinking here are trying to capsulize what of the most important strategic messages bas based on the preparations and the questions asked in the last hour and a half or so and if I articulated them back in a certain kind of way here maybe I could get the panel to comment on them. One is I think sort of this general adjoinment that the whole objective here is to stay ahead of the curve, whatever the curve is and that clearly some sense of -- of offense in openness and defense in mix is required here. I got a sentencing from the presentations that most people think in this particular area the Jeannie's already out of the bottle and it is only going to get worse in terms of the jeannie being out of the pottle. bottle. Some defense is required to catch the inadvertent to raise the sensitivity that it is important or to slow down the process to buy time is some sort of strategic factor here but that again offense and openness, that is, research to blunt whatever might come in the future it an important -- is an important factor here or to focus on specific threats if we are able to do that at some point or other processes that we haven't yet discovered. That is sort of a again ral capsule rundown of what I seem to be getting out of this from a point of view of strategic messaging which I'm still trying to interpret. I think there is a question there some where.

Woo we can have individual -- we can have individual journals have some type of a reserve process and have IRBs check the box and look at your proposal and have investigators even keeping track of this but what dual use is is always going to be a moving target for us and seems like at some point we are going to need to have a group that is helping to decide what dual use is on a case-by-case basis on a day by day basis and in what the context is because the context is going to be continually changing and so this isn't going to be something that Q3 we can say if 80s E. coli A12 it is okay. It is something we have to redefine on a regular basis I'm afraid.

I would like to ask you a question. I really enjoyed your presentation and the scope and the thought of it, but if the process works of the culture responsibility that's translated to the IBCs through principles that come from the NSABB and experiment -- an experiment itself may be discouraged being done if it turns out to be something that might be a serious issue. But if it goes through the process well, can you conceive of in the biological sciences any ease ?F piece of work that you feel shouldn't be published?

I'm going to reveal to the world that this is a question I asked him some way back and --

[ laughter ]

And the answer was no or the answer was almost know no and I never discovered what it was that he thought you should conceal. The answer is no when you come to the basic research and question about the again knee Geneee being out of the bottle has to be the basic research. The weapon zax questions and questions about the papers we talked about. The polio sin synthesis sort of a paper. Those are papers where you can have a genuine debate about whether they should be published or published in the way they were published and so the question is what -- where do you shave a off between the extreme case and the basics? And this is the first group of people who have gathered together with the specific job of addressing that and I await their deliberations.

Just to get back to the previous discussions I -- I agree with your completely. When I look at fund fundamental basic I find it very, very difficult to come to a conclusion of something that you should hold back. When you are talking about a recipe to do something, that is when it is pretty clear that you have got to be careful about that. How you make this or how you do this. Which is the reason why as you said the botch you you about the eye brngz botulism really generated a lot of [ Indiscernible ]

[ Indiscernible ]

Take that responsibility. We also have to be careful that IBCs can be different and some people may take their responsibility too zealously so we have to be clear on what things need astronaut any so that they don't over interpret the responsibility and shut down too much research at that early stage.

Back here?

A question for Dr. Campbell. You have a system set up already for review which sounds like a reasonable approach. If we were to say what could this body to TKO? to help you at this pint in time what would your answer be? What kind of activities could we do that would be of assistance?

One thing you could do it give to us a list of other sources of advice and might even want to consider whether that is a public source of advice, not about the individual consultations that we would make but in terms of as of a publicly consulted group of people.

I think Dr. Fauci began to hit it. The way crystallize is going, one might be emerging, you know, another [ Indiscernible ] but maybe a little bit of and that that is basic research I mean weapon zax is a zaxization is a form of applied research. You want to Figure out how to disseminate the force and already applying the basic sighness to do something with it. Whereas the basic science may be dual use but it is difficult initially a priority to restrict it where as once you begin to cross into the application then you may be at the ebeginning of an emerging distinction between what we want to come to grips with.

[ Indiscernible ]

I think one of issues that we are dealing with here today is still trying to get our arms around what is is T. that we really are concerned about and I come back to I think our earlier comments that you know what happens at Los Alamos is so unlikely to ever be a major problem because you have to have access to material, you have to have a way to deliver it and you put it all together and given the security you have one wouldn't necessarily say it is over kill but on the other hand you could say that it would be very difficult even if you didn't have a level of security soion cute some type of adverse event, a terrorism event based on that. I think for us what we are I trying to get our arms around is that there are many, many possibilities to do something bad that are relatively easy to do. We have given you examples already. I would add it is interesting to note that of all the ones I'm aware of in this country they obviously have either been food or been through the mail I won't comment on the and anthrax situation, not knowing. But basically all have been domestic sources. Ask ourselves again what is it that we are really trying to do here. I mean trying to keep the is is a Gela out of the salad. Trying to stop the anthrax spore that has been put together from being disseminated. Any of those have a different level of scrutiny or control and I would sate to see us try to -- I would hate so see us try to run lab laboratories and publications and public health around the issue of shigella in the salad bar, there has been so many reason experiences that somebody push riched published on that that wouldn't be a concern to me. Part of what we are trying to do is work this. I think it going to take time. I think it going to take going through and taking is a nare yos and beginning to understand what do they mean to us and is this a problem or not. And so I fear that we grg to try to come out of here with this is dual use, this is what we should be concerned about, this isn't what we should be concerned about. I think it going have a lot of common answer sense applied to it and locally we have to have people basically arm's length away saying have we thought about all these things are these the possibilities. The last thing I want to say is I have a guy ya's here and I know this will go against the grain here. There is no such thing as a weaponized biologic agent. It doesn't exist. It is a misnomer of terms. Any biologic disease can be Wen weaponized. Foot and mouth disease merely bringing an example and releasing it in a barnyard. Even anthrax is not in a sense weaponized. It the about the bug and the way to deliver those. I made the point that if it doesn't have a way to be delivered it isn't a quote unquote serious problem. And so I think we have to be careful, too, because I hear that terminology and unless somebody can convince me differently and they haven't been able to in four years. There isn't any egg such thing such thing as a weaponized agent. That is going to get us I think in trouble if we try to really focus on weaponized agents.

And we are not going to convince you today, Mike. This is going to wrap up this portion of the session and we going to move now into the public comment stage. This stage will last for only 35 minutes. If you registered it is time now for the audience members that have registered to make public comments. This session will be 350 35? minutes in -- 5 35 minutes in length. Keep your comments British brief and to the point. We will limit the public comments to 3 minutes individually. When I call your name please aappreciate the microphone and address the board. At the three minute mark I will ask you to stop and give you just a few seconds to finish up and summarize but at that point then it will be time to move on to the next speaker. The first public comment will come from Shanae from Washington University in St. Louis.

I represent Midwest regional center of excellence for biodefense and emerging disease research. My comments are while biosafety and biosecurity share many features there are significant differences. [ Indiscernible ] focuses on occupational health and environmental protection. Biosecurity on the other hand focuses on public health and the national security. That the potential impact of failure is much broader than in biosecurity. As a result of these differences existing strategy of compliance with the NIH guidelines which include [ Indiscernible ] by the institution of [ Indiscernible ] safety committee and primary investigator documentation and training may not be sufficient to deal quickly -- adequately with biosecurity issues. Developing a additional strategy is essential. We believe that the additional strategy should focus on culture change in biological research communities in terms of biosecurity. Biosecurity plea precautions and procedures should become part of daily activities for everyone who works in the laboratory. To change this cull culture can often be a challenge ease especially for those highly educated and a strong scientific mind but it can be done. The most effective way to accomplish this culture change is through education just as proposed by NSABB. AA mandatory education program for all scientists and lab worker and in our opinion graduate students should also be consider. Additionally a strong partnership between science and the regulatory communities should be developed. Scientific surveys and state analysis should be in were incorporated into the policy. And we should implement a feedback system to monitor progress in this age of bioterrorism and wide availability of biotechnology is is long over due dew for [ Indiscernible ] and [ Indiscernible ]. Thank you.

Thank you. Doctor, gair reeled Epstein Gerald Epstein from the center for strategic and international study.

Thank you for the opportunity to address this you. This has been a fascinating meeting. There is no body or Interpublicty institution that does anything like what you are trying to do. Is the board mission. What is in and what is out and I heard two attempts at trying to find things that we don't have to do. We have a hard job to find things we don't have to do. There is a whole set of area where is is too late to change. The Gene knee is out of the bottle and we don't need to look there. Basic Funt fundamental research it is too early to tell. Where you need to focus is to look for something which might be in between. It might be possible there are things not soth at the both at the same time. If there is both there is not a lot of value at looking at it. When I have been trying to think through this topic was what are we trying to get at the definition I came up with I called contentious research and define that to be fundamental, biological or pie bye yo medical investigations and [ Indiscernible ] and therefore raise questions considering weather and how the research should be conducted and disseminated. This is my operational definition of what the it is. Not a set of criteria or concerns. It is operational. I say it raises question. , there is two kinds of questions. Questions well founded. Should the work be done. Should it be published. More harm than good. Difficult as it may be to come to the assessment but is there a real reason why we should think seriously before going ahead and doing something. In a society where research a funded by public dollars and tolerated by public concept there are also questions that may about the know about some sense well foined on a technical basis but questions that people have and I would suggest that if research is done and races questions and get -- raises questions and gets people worried and the political system alarmed that is something you have to worry about whether or not that question is one which you think is well founded and it is your responsibility or let me up it a little bit it is the scientific community's responsibility working other stake holders to have answers to those questions. The answer may be that is a good we and Q3 thought about it and here it the process we have in place and here is is why even though it is scare scary to go down this road it is more dangerous into not to than to do it. That is an answer. It may not convince everybody but it is better than it has no good or bad, we don't ask that question we just go ahead.

ahead.

I used to work for an agency of U.S. Congress and used to say Congress is a blunt instrument. A big red button and a little green button. Now, I would say they have a big red button and a little green button. Is the way to get it slammed, saying these are not in our purview and not our concern that button is going to get hit. This board's job is to make sure we have answers when the questions get raised. I want to thank each of you for serving on this board. It is a difficult time and I'm glad you took the time to do it.

Ed Hammond from the sunshine project.

STKPWHR?FR.

Thank you are opportunity to speak. I have two comments. Something that I observed at the beginning of the meeting. I note or in my understanding the was to have public members and unless I missed it I didn't see a public member or members on the board and that would be a useful thing to incorporate because organizations like maybe and other public commenters with work through public members to raise concerns. So I would appreciate a clarification thon. Secondly, my major purpose in asking for the floor was to introduce this paper a copy of which I provided to TO? each of the members of the board and which I hope you might be some what familiar with already. It is mandate for failure of the state of IBCs in an age of biological weapons research and covered in science in the chronicle of higher education. This is a survey that the sunshine project did of 90% of registered IB drsmds in the CDs in the U.S.,. We were trying to assess how fear of trornl -- what we discovered was far more disturbing than what we intended which AFS debate over transparency. We discovered in large measure although there are many exceptions in large measure the IBC system is something of afication. And I think that that shows that the NRC was some what in cautious or arguably erred in the 24EU6R7BG report in reming local review not because local review in and of itself is something -- is bad or a bad adebut because the system there to perform the reviews is in a very sad state. We found widespread disregard. Widespread noncompliance with the NIH guidelines. The first experiments to insert 1918 Genes into in flew Wen Wen da went ahead without the rule despite the regulations and rules requiring compliance at the NIH guidelines 60% of government IBCs did not provide their minutes. An institution that approved 4 dozen research protocols including select agents at BL3 and recombinant DNA and the IBC never met. We generously estimate that 10% of the private sector is compliant with the NIH guidelines and has a ridge sthrered IB cbrsmd. We found many that have never met or met once, maybe twice. I could go on and on and on and on and sadly don't interpret this the wrong way it includes most of the institutions that are represented on the podium before me I found problems with the IBCs. So the bottom line is no matter how will Brill brilliantly and well, you do your job and for myself I have a very open mind and welcome the effort the bottom line is that the local committee system that you are relying on is failing at its present mandate and to heat this mandate on -- heap this mandate on top of it poses some serious problems. So you will have to devote considerable attention to making sure that these IBCs actually exist, comply with what you recommend and that there is a real Bo bona fide process of review going on. I think a significant number should require national review and I'm being told that my time is up. Thank you very much for the opportunity.

Thank you, Mr. Hammond.

Next on the speaker list is Brian Hanley from the beg id cation and forensics. That is the only Title I have. Mr. Hanley.

Yes, I want to primarily comment that there is a kind of a pervasive sort of back follow thing where you are talking about addressing a biological weapons problem and we are extremely naive about biological weapons in general. I'm talking about this from the side having done a serious red team scenario shrewding Sim including simulation, et cetera and what I would say and specific basis is go TWO? things. One is of all the things that came to me as I did this the primary thing I see us having a shot at controlling which actually requires serious expensive resources is controlling -- is controlling access to very sophisticated simulations. NIH allocated a grant this fob make episims public domain in its source code and I would strongly disagree with that. It has accurate demographics for American cities. It has GI sismd. Very sophisticated and it will away you to war game if you turn it around. So that is very -- that is one simple thing. The other one is that in doing this exercise what became clear to me is that your primary problem becomes how do you know something is happening and currently we depend on extreme symptoms and we depend on people dieing in order to know that. We are very unsophisticated that way. I would point to the environmental defense foundation's proposal which some of you might be familiar with to use blood serum to continuously survey what viruses are in circulation so that we start finding out about true more morbidity and what the background truly is so if something shows up that is pod we will see this. I would also point out relative to whether or not we have engineered or, you know, natural terrorists kind of .

Original.

I will close by saying that I think the primary focus of this board should be far less on control of what gets published and far more on focus on what research needs to be done and where to direct things. Sigh entities are not -- scientists are not the problem. You guys are going to be the ones who are did going to direct the people who are going to be able to direct these issues if they can be clarify.

Thank you administration Mr. Hanley. Next is rob heter Harris Robert Harris from massy Max resources. Rosh Bert Harris? Okay. I'll give him a count of three. All right. We'll move along then. The next on the list is David Silverman from Stanford University.

In addition to my other roles I'm also the community member to the UCSF biosafety panel an active participant at Stanford's IBC and in my day job I direct the health and safety program at the school of medicine at Stanford University which includes a lot of compliance related issues. Some of the observations I have made is that when you are dealing with a guideline or a regulatory con seventh September in large and diverse community it is also a good idea to look back ward and see what worked in the past. I think it is to our credit that Phil has come -- [ Indiscernible ] has come up and this is the 30th year anniversary of that conference. In addition to health and safety we have other concepts one of which is known as performance based Stan Stan. Something that has worked by experience. No one has dictated it. Just one of those things that fell out. We look to that for a reference point. And that is not to say that we don't try to refine it but it is a place to start and I would Your Honor you to consider -- I would urge you to consider that. Also in dealing with investigators and principle investigators they respond more towards reason than regulation and guidance than Dick takes gi think that is clear. I would urge you to also consult the individuals Wern the in city -- within the in city institution charged with the responsibility of making sure we are in compliance from the humble biosafety officer to the ex-all theed price provice prohaves for health and safe tiff. Lot of people who know how to work with faculty. I should say we have our ways. Isn't that right. Okay. And one other comment about balance. A lot of discussion is focused on balance. I would urge you to think that it isn't necessary for the Fulcrum to always be in the middle. Sometimes it could be at the extreme end and you will stillster balance where you have a lot of research, a lot of science and only a mod did I mod d icum of security. You don't need a lot to off offset a lot. I'll conclude my replashings with that.

Thank you. Our final public speaker is Terrence Tay lar from the national counsel for the life sciences. Terence?

Thank you very much. I'm very pleased to have been given the opportunity to address the NSABB. I come from the international Interpublic city institute for strategic studies whose member high pressure reaches reaches out to over 100 someone trists countries around the -- countries around the world and I have the good fortune to head the U.S. part of the organization. We have developed with funding is support from the nuclear threat initiative from the global health and security program the international council of the life sciences a chapter based organization. I'm -- I'm impressed by what I have heard today because the center piece of our work and inspiration for me in undertaking this project was very much that the focus should be on people and knowledge in the life sciences area and that is huge hi important and the second phrase which we have heard from the beginning from doctors that our mantra when we began this project was the culture of responsibility. I tell you why, because we -- drawing on Dr. Stewart levy's remarks at the beginning is that we should take a positive approach with the culture of responsibility die idea in my view you are pushing on a door that is already open. Our work around the world on this process whether it is in industry or government institutions or academic places want to behave responsibly and I'm not looking at the world through rose colored spectacles because I was also a wet lands inspector and interviewed people including the doctor who you saw in the photograph earlier on and she represents one end of the spectrum but the over whelming majority of people that I have interacted with with this project and previously will buy this idea of a culture of responsibility and I was delighted to hear that repeatedly today and that underlined our projects. It is clear that this question of balance, it is clear that the advances in the life sciences are bringing and will in the future bring enormous benefits and that is another plank on which to build particularly in the international realm because this council that we have set up I think is directly responsive to that activity you have which I think you used the word coordination of national research. I think a better word might be Harmonization. Coordination is very ambitious. One needs to think about the idea which we in our mission statement which Mr. Chair man, you have a copy of our charter with you our mission statement is by promoting best practices and promoting codes of conduct because we believe that there will not be one global code of conduct that will operate over every professional area and also for every region of the world. What we have vee created a is charter which formed the structure under which a number of codes of conduct ap cable in professional sew sigh ties around the world thew they could operate against and so I think I would urge you to have a look at our charter and our organization stands ready to support you in your work particularly on this international outreach aspect because I think you have to take that in from the beginning and in terms of obviously you have to work things out internally but you have to take the international scene and how they are thinking around the world from the beginning. Thank you.

Thank you, Dr. Tay Taylor. We hope to see you tomorrow when discussing international issues. I hope all of you have found the information presented today as valuable as I have. Lots of interesting discussion and good points being made. On behalf of the board I would like to thank Dr. Zerhouni and Dr. Fauci on their comments in support of the board and thank the audience for joining us today. It is apparent from the turnout that biosecurity is a subject many people are interested in discussing. Finally I would like to express my gratitude to the speakers for traveling to Bethesda to share insights and expertise for us. You spiced things up and giving us new insights. Tomorrow we begin at 8:00 a.m. Code of conduct in the life sciences. The second session is dual use research international perspectives. And finally, the chemical sin that tis of bacterial and viral genomes. With that I'll adjourn the session for today and hope to see you tomorrow. Been