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 probab