[LUNCH]. [Please stand by] >> Ladies and gentlemen, we're about to start. If you would all take your seats, please. Welcome back for those of you who were here this morning and those of you who are new, welcome to what has been to this time at least -- and I'm sure will continue to be a very interesting and engaging set of discussions. In his letter to the commission, President Obama asked us to consider this research's potential benefits, medical, environmental, security and others, as well as any potential health, security or other risks. This, our third panel today, will address these issues, including whether synthetic biology offers unique potential benefits distinct from those that come from other types of science and technology and whether this technology might be applied to potentially dangerous ends. Our first speaker Dr. Allison snow is a professor of evolution, ecology and organismal biology at Ohio State University. Dr. Snow is a fellow of the American association for the advancement of science, a past President of the botanical society of America and a former officer of the international society for biosafety research. She was recognized by scientific America as one of the top 50 researchers in science and technology. Welcome, Dr. Snow. >> Thank you very much. It's great to be here. Do I need to start this timer? >> Yes. >> Thank you. I'm really pleased to have a chance to talk to the commission and the other speakers here today. And I'm going to offer you a very different perspective I think definitely from what we heard this morning. So I think we all are learning as we go here. And I will give you sort of an ecological perspective. As a background I'm a plant ecologist and study gene flow three pollen and seeds and hybrid species and assessing ecological transgenic crops and especially those who hybridize and I have 20 years of experience, working on these related to transgenic crops. And I'm interested in all genetically organisms I refer to as GEOs. I was the lead author of the paper of the ecological society of America. Some of the details I'm talking about are fleshed out more in that paper. To set the stage for my comments, I'd like to talk first just for a few minutes about what ecologists do. Just to give you a brief overlook about professional ecologists, we are professors, graduate students, wildlife biologists, natural resource managers and other researchers who investigate interactions between organisms and their environment. And so I mainly am thinking as my title slide suggests about the environmental releases of new organisms. Our field is very interdisciplinary. We study all types of organisms from microbes to plants and animals and all types of habitats all over the world. We often focus on one level of organization, such as populations, communities and ecosystems. And we look at many interrelated processes such as competition, predation, mutualism, the cycle of carbon, nutrients and energy in the environment. And some ecologists like me study rapid and ongoing evolutionary change. Much of the research that ecologists undertake relates to practical questions in agriculture and forestry, aqua culture and even urban planning. A common myth about the natural world is the idea there's a balance of nature, but nature as many of you know is not in a state of equilibrium. It's in a constant state of flux. And also organisms are not perfectly adapted to their environment. This means that in some cases, NUTRATES could allow a species to be more successful than previously. Ecologists are aware of the need to sustainable approaches for growing food and fiber and creating biofuels. And we hope new approaches to these global problems can be attained using the field of synthetic biology. Now I'd like to focus on some possible environmental risks of releasing synthetic or partially synthetic organisms into the environment, whether intentional or not. So far, there's been very little public discussion of environmental risks. I was glad Dr. Venter brought this up this morning. But usually, the environmental release questions are eclipsed by concerns about biosecurity and also by heavy emphasis on the benefits, potential benefits of synthetic biology. I think that in order to evaluate environmental risks, we really need specific examples. And we don't really have a lot of those yet. We heard this morning that some of the applications aren't ready yet. So that makes it difficult to look at specific examples. As with previous GEOs, there's going to be a great deal of variation among different applications and their potential for harm and potential benefits. And this is going to require a case by case approach. I don't think we can say all synthetic organisms are safe or all are dangerous. So far, most applications seem to be in the early R&D stage. Those that are farthest along may involve completely contained synthetic organisms. And those should be less worrisome to ecologists than environmental releases. Although leakage outside of contained facilities might occur and we need to know whether this would ever be a problem, especially when this is done at a very large scale. For applications that involve bacteria, we heard about microbes this morning, I think it's important to remember that a bacterial cell is a self-replicating organism and sometimes when it's just referred to as a cell or a machine or a chassis, lay people might get the idea that this is not going to go out and reproduce in the world. But let's keep in mind that a bacterium is an organism. Applications that are mentioned most original for field releases involve microbes and algae such as those grown in ponds for biofuel. This is one of the clear examples going forward quickly is engineered algae. Unfortunately, it's hard for the public or researchers to know exactly what's under development. And this is partly because we're early in the stage, but also because a lot of this information is proprietary. And the parts moving quickest are being moved forward by an industry and that is not public information. For example, ExxonMobil is spending hundreds of millions of dollars to develop genetically engineered algae with synthetic genomics, the company that Craig Venter has founded. We don't know details yet. I dug around before this meeting to try to find out more about what they were doing. I couldn't get any information. It would be useful to know what type of algae they are working on, whether they will have suicide genes if they are going to be grown in open ponds or maybe they are going to be in bioreactors, will they be in freshwater or saltwater, all of these kinds of questions would be helpful if we had answers to those. So as a general framework for evaluating risks, I'd like to say a little bit about what I see as different from synthetic biology compared to what came before. And as many of you know, there's no clear distinction between traditional genetic engineering and synthetic biology. We were given a notebook with a lot of different definitions. People have been making synthetic genes for years so that's not new. But both can involve the transfer of genes that confer NUTRATES into a recipient organism, it could be one or several genes or a whole genome sometime in the future. So right now we're at that intermediate stage where it's one or two or several genes into the new organism. And I view synthetic biology as a very advanced type of genetic engineering. A recent article in "Scientific American" called it scientific engineering on steroids. Maybe that's a good analogy. Regardless of which new GEOs are proposed for outdoor settings, I'd like to review four general guidelines ecologists would offer of what should be considered. And these are discussed in more detail in some of the reports that you have been given. The first guideline is that we do need to be very careful whenever self-replicating organisms are released in the environment, especially if it's an intentional release but also for unintentional releases. Many of them will do no harm whatsoever. But important exceptions could occur, especially if the genetically engineered organism can multiply and become more abundant out in the environment. Just as a hypothetical worst case scenario, maybe we might someday have blue green algae engineered for biofuels and they have to be very hearty to survive in outdoor ponds. So they have been engineered to be hearty, high-yielding, blue-green algae grown on thousands of acres. And they might spread to natural habitats and might spread to lakes or rivers or streams where they could start flourishing. And they may be better than the algae that are already there. And I'll go into this in a little more detail. But they could have the potential to displace other species and create Algo blooms known for suffocation of fish and other aquatic life and some release toxins into the environment. This would be a bad decision to go ahead with this application. It's just a worst case hypothetical scenario but gives you just an example of wa we want to avoid. In some cases a GEO might spread to new climate zones or new habitats like other invasive species. A second general principle is that novel GEOs that seem innocuous or have suicide genes might be more successful once they start reproducing out in the environment. Even if highly domesticated, mutations and other unexpected properties might allow them to survive in certain environments. Physical containment or biological containment sometimes given by suicidal genes or chemical dependencies may not work forever or in all cases because mutations and human error and unexpected events might allow them to escape. And it would only take a few to escape in order to propagate. So if they really were hearty, these techniques may not be successful at containing them. Also, the potential for rapid evolutionary change is especially high in microbes. And some will die out, but others could thrive and evolve. Especially GEOs that could exchange genes with other lineages or species could create hybrid progeny in which the new successful genes would be promulgated in descendents. We can't necessarily assume that all domesticated or supposedly suicidal GEO organisms are not going to be able to persist in the environment. A third guideline is that once these organisms are released, they cannot be taken back. So this is a really big difference between a chemical spill or pollution where it might be able to be cleaned up or degraded. It's just obvious fact that organisms that reproduce have the potential to be out in the environment forever. There's no way to find and kill every last one, especially in the case of microbes. But also for plant and animal species. We have never been able to -- very rarely in the whole history of trying to get rid of an invasive species have we been successful. So the dispersal of some GEOs could be rapid and widespread and we have seen that with other species as with globalization and traffic around the world. It's very easy for organisms to spread. A fourth general guideline is predicting which new organisms might cause irreversible harm is extremely challenging. This is much easier with a genetically engineered crop like corn or soybean because those are domesticated. We have a lot of familiarity with them. They are completely dependent on humans and they don't have any wild relatives, at least in the United States. So with some of our earlier experience with crops, it's been easier to have a baseline for comparison and to look at the new characteristics and say we don't think this is going to cause problems in the environment. However, we don't have much experience with cultivating micro algae or bacteria outdoors, let alone new life forms that might be entirely synthetic. New types of really different bacteria, no experience. This brings up the question of whether regulatory agencies will be able to monitor and evaluate new times of synthetic or partially synthetic organisms that are proposed for release. And I'm glad that Michael Rodemeyer will be addressing this tomorrow. It's a big one. In summary, the challenges in approving novel genetically engineered organisms for release are expected to be much, much larger in the next five to 10 years. And so this is something for you to think about. To begin to tackle some of these issues, I think the general public and public researchers need more information as soon as the first applications are being developed. Which is now. They are really being developed now. And bioethics decisions you all will be thinking about, you need accurate and realistic information about how the technology will be used. It's like any technology. It could be used for good or bad. And you need more information about that. Which species will be developed under what conditions for outdoor releases? What are some possible risks? And what are some possible unintended consequences? Before regulatory agencies decide on whether an application should move forward, assuming they can be regulated, we need analyses of ecological risks and benefits. And these analyses should not just come from the industry that's developing them, but they should be independent. Ideally, they would be accomplished in peer-reviewed journals or other types of reports available to the public such as National Academy of Science report. A good start for micro algae would be to publish professional mono graphs dealing with the ecology of each species and close relatives including information about how they reproduce, how they spread, whether they exchange genes with other strains, whether they have been bred to be suicidal, whether they could become more abundant or might die out. And whether they produce any kinds of toxins or other side effects. Ecologists can help with the development of synthetic GEOs that will minimize risks and ecologists will want to get involved as this moves forward. For example, the choice of organisms and the traits should be discussed in light of possible ecological risks, outdoor risks that many engineers and molecular biologists don't normally think about. You need many people thinking about these issues. And key knowledge gaps can be addressed with research. But ecological research takes time and funding. This is why risk assessment research shouldn't be left for the last minute. It should go in tandem as the development as these products is moving forward. When more is known about specific applications and possible risks, it would be great to have a lot more open debate and discussion. This is necessary to avoid bad decisions and allow safe uses to go forward. I think there is a good precedent to that, even with non-transgenic biofuel crops. There's a lot of discussion about which crops should be used and under what conditions. There's a lot of publications out there. It would be nice to have another layer that would include these new organisms. So in closing, I'd like to read a quote from an editorial about synthetic biology in "Nature" magazine that maybe most of you saw. It's from May 27th, 2010. And the title is "Challenges of our own making." The editors say and they mention this committee. And they say that, quote, where there are concerns, they now need to be developed beyond the knee jerk soundbyte. And I couldn't agree more. We have had to use a lot of soundbytes in our short presentations. But I really look forward to a lot of deeper discussions and debates on these issues. Thank you very much. >> Thank you very much, Allison. And what you call soundbytes, I think, is way more subtle and sophisticated. >> I didn't think so. >> And highly informational than what goes for soundbytes in the world out there. >> Okay. >> So thank you very, very much. Next is Jim Thomas. Jim Thomas is the Programme Manager with the ETC Group. It is a Canadian-based international civil society organization that analyzes the impact of new technologies on society. Mr. Thomas is a prominent critic of synthetic biology and has gone on record opposing voluntary governance strategies for the field. And I'm sure we'll hear some more on this. He is importantly the author of "Extreme genetic engineering, an introduction to synthetic biology." Mr. Thomas, we look very much forward to your remarks. Thank you for being with us. >> Thank you very much. That was a good one. And to the commission for inviting me to this more than and very important meeting. I am encouraged that President Obama is choosing to examine synthetic biology. I hope this really opens up a debate that will allow for the proper regulations and oversight of this technology. I speak for the ETC Group. We are a technology watch dog that have been looking at synthetic biology for about five years now. And mandated to work with global civil societies, so environmental groups, indigenous groups, farmers movements, to understand how this technology impacts the disadvantaged and the dispossessed who in fact make up most of the world's population. I do very much hope there will be an opportunity later in your process to hear from such communities directly about how synthetic biology is going to impact their livelihoods, their territories and their rights. And I'd very much echo and support some of the concerns you have heard from professor Snow about the environmental releases of synthetic organisms. You may be aware that the U.N. convention on diversity has a sensible moratorium and one by the ethics commission group and long-term before they have been counted. And organisms should be locked up in the research lab and that's different from the commercial biorefinery which is potentially very experimental. But I'd like to mostly talk about -- what I'd like most to talk about boils down to one phrase. To remind myself I have actually put it on a button. It's the bioeconomy, stupid. And that's a message to me to remember that. Although I have extra buttons if you'd like some. In fact, I was tempted to write it's the supervised bioeconomy. That might have been more appropriate. And the point is any meaningful assessment of synthetic biology as a technology has to grapple with the socioeconomic impacts of the industry that it gives rise to. And it's this new platform of engineering cells in the factories in order to make chemicals and fuels and plastics really work. If it does, it's going to have a radical different model of production that we're going to see that's being variously called the bioeconomic and biobased economy. Having watched this five years, I am convinced what matters is the emergence of the bioeconomy that it creates. If you don't look at that broader economic shifts that are at play, you're going to miss the real socioeconomic impact of synthetic biology. The bioeconomy that will reshape the world and impact rights and potentially fuel inequalities. To give you a sense of what I mean by this, about how technology can really shift an economy, I want to suggest an historical thought experiment. Let's imagine that it's 1828 and this commission is being brought together not to look at the synthesis of a genome but of urea. And you've been asked to look at the implications of the emerging field of synthetic chemistry instead of biology. Playing that historical game turns out to be illuminating. Although history doesn't repeat itself mark train says it sure does rhyme. And questions in the early 19th Century critics and contemporaries asked about synthetic chemistry. And will the synthetic chemistry lead to overbearing monopolies. The last two questions result themselves in the following century. We saw synthetic chemical in the gas chambers in Auschwitz, over Vietnam and in the case of IG Farben emerg. And I think what's interesting is the questions like what would synthetic chemicals mean for human health and the environment. That question didn't get airing until 1962 with Rachel Carson's silent spring. And even when she did bring up these questions, she was vilified an attacked as an emotional and unscientific woman, as being an alarmist just as voice os on biotech are approached today. Truth is she wasn't alarmist enough. If you look at the situation, the community of color in Louisiana's cancer alley or women who are every day feeding synthetic chemicals in their breast milk to children or we live under a hole in the sky created by synthetic chemicals, though situations would be been hypothetical and far fetched in 1828 but history changes that. Imagine you said to an 1828 ethics commission about the litany of wars and environmental destruction that came not so much from the products of synthetic chemistry but from the quest to secure the feedstocks to maintain the industry that came from synthetic chemistry and from oil spills in the Gulf of Mexico to oil wars in the gulf of Persia to the engulfing climate process. The industries have not only transformed fossil fuels into plastic explosives and so forth, but they have transformed our global economy even transformed the atmosphere. And today's synthetic biology industry says they are going to get away from all that. Dr. Venter, even making deals with BP and Exxon hopes to put the petro chemical industry out of work proposing a biotech in which it's the key feedstock of production. This is the bioeconomy, the bio-based economy we hear so much about. And it's the reason that synthetic biology is attracting so much money from fortune 500 companies, like flies around fermenting biomass. What matters to them is that synthetic biology might make this bioeconomy possible. And so gene giants and forest barons and agro bis hope to hold the bioeconomy, stupid. That's what matters. And I think in the process, it might become like the petro economy trying to guarantee the supply of sugar or cellulose or algae for the vats of synthetic organisms pumping out product, it will require a mass reorganization, a grabbing of land and stripping away of plant matter and nutrients that could affect every part of the planet and some of the lives of the poorest people on the plannest. I think we can begin to see this under way. I want to consider three snapshots of the syn bioeconomy. We have heard about Amyris biotechnologies that next year will produce a hydrocarbon fuel from cane sugar with synthetic yeast in Brazil. And the taking of sugar for fats and other biorefuneries is increasing the sugar-growing region destroying second only to the Amazon of importance in Brazil. The sugar itself is cut down by Brazil's Army of landless migrant workers who undertake back breaking cutting which puts them out of work by 25. It wears them out. And the burning of the sugar cane releases large amounts of toxins and illnesses and also a large amount of greenhouse gases making Brazil the fourth largest emitter of greenhouse gases in the word. Amyris claims this the a no compromise green biofuel. And I suggest the sugar slaves and those whose rights have been compromised would disagree. In a way, they are already being affected by the bioeconomy. A second snapshot. We have heard about the work by Amyris to produce the acid in a vat, it's a laudable public health goal, this method of production is not necessarily the most just approach. It looks to undercut the price of natural art meesia and the fact is that the artemisinic. And the synthetic dyes put ot of business large numbers of indigo farmers in India and have mass starvation in a short period of time. I'm not saying the artemisinic farmers will necessarily suffer this fate but there will be economic dislocations as we begin making our vats of synthetic microbes out on the fields where people actually work. Jay Keasling of Amyris is fond of saying synthetic biology is anything that comes from a plant can now be grown in a vat. While many of the poor of the people in communities in the world depend on selling plant-grown commodities and just the prospects of replacing those commodities with synthetically grown commodities is going to worsen the economic situation of the world's most vulnerable people. A third snapshot of the economy, the new bioeconomy, I'll go back to the question of algae. And Dr. Venter's algae project with Exxon, he talks about turning sunlight and carbon dioxide into hydrocarbon fuels. There's much more at play. You require large amounts of water, nutrients and most importantly, land. And in a time of water crisis, we're going to see additional amounts of water being pumped probably to deserts, rather than to agriculture. We're going to see night gent and phosphate-based fertilizers added at quantities higher than currently added to crops because there's no soil in these systems. And the fertilizer production is not only energy intensive but in phosphate fertilizers, it's currently peaking. The reserves are in decline. What phosphates we're now mining needs to be prioritized for mining. We're looking at a dilemma that is still pushing people into hunger around the world. And the land required is not insignificant. Dr. Venter told Congress he was looking at facilities about the size of San Francisco. And but in fact, McArthur genius Griffith has calculated if you come up with a synthetic algae four times more efficient than current algae, you require one Olympic sized swimming pool every second of algae, every second for the next 25 years in order to reach just half a terrawatt of energy. And that's like putting slime over all over Texas and Arizona. The world uses somewhere between 12 and 16 terrawatts, most from oil, coal, gas. All this points to an underlying fallacy with the idea of the bioeconomy. The assumption that somehow there's enough biomass water, nutrients and so forth to sustainably transition to using living feedstocks and really there is human beings already appropriated about a quarter of biomass. And if you want a sobering reality I ask you to look up the term earth overshoot. It refers to the way in which as societies are already going beyond the carrying capacity of the planet in terms of appropriate biomass, water and other ecosystems surfaces. And every year, the fate at which we're overshooting that capacity gets earlier and earlier. Last year, the 25th of September and that's over 25 years of this. So that's not in any way a renewable economy. It's potentially a very stupid economy. And what's not stupid is to be able to act with foresight, intelligence, and humanity. And that's what this commission has the historic opportunity to do now. The fact was there was no commission of inquiry into synthetic chemistry in 1828. John Quincy Adams was not Barack Obama. And there weren't professional ecologists to organize civil society to think through the implications and offer cautionary voices about the terrain ahead. And President Obama has offered you this tremendous opportunity to learn from history, rather than to be doomed to repeat it, rather than for it to rhyme. And you get to ask the important questions now, and not centuries too late. I really encourage you to be brave, thoughtful, far-sighted in your analysis. And the ETC Group and other groups will be inputting into this process. And very much ready to help in understanding what synthetic biology and the bioeconomy it creates means for our common future. Thank you very much. >> Thank you, Jim, very much. You have given us a lot to think about and to deliberate down the road. Nancy King, our third speaker on this panel is a professor of Social Sciences and Health Policy in Wake Forest University School of Medicine and is director of the university Centre for bioethics, health and society. Her scholarship addresses a wide range of issues in bioethics. Professor king was also a member of the NIH recombinant DNA advisory economy. We are very happy that you can join us today. >> Good afternoon, everyone. I'm honored and humbled to be able to attend this first meeting of the Presidential Commission and to be included among these scholars. My contribution to this discussion is almost seems to me like a recap of things we have already heard today. A reminder of things we already know, a lot of which have already been discussed and have definitely been addressed in much of the literature as you saw in our briefing books that have been mentioned. All of these are things we need to keep in mind as synthetic biology and related biotechnologies continue rapid investment. I'll Mike a few basic observations. Number one, risk and benefit are not parallel terms. We should always talk instead about assessing and balancing risks of harm and potential benefit. I'm actually glad to hear that President Obama was careful in his use of language, but many of us aren't. It's especially important in the research context to use terms carefully when experimental interventions have not been proven safe or effective. Now, if brevity is essential, we should talk about benefits and harms, rather than risks and benefits. You can easily see why the longer terminology is preferred because it is complex and we need to evaluate benefits and harms rather than speaking loosely about them. We need to talk about their anticipated nature, magnitude, duration and likelihood. Why does it matter to be so clear and specific? Yell, there are at least three reasons. It helps us avoid the misleading implication that benefits are certain and harms are unlikely. It Helms promote a more nuanced understanding of potential benefits of harm from any intervention. And it ensures recognition of the trade-offs that exist in every medical and scientific advance. Now, observation two assessment includes context. We have already talked some about the context specificity of biology but assessing risks of harm and potential benefits is also always context specific. It really matters what you're developing and how it will be used, obviously. The context includes consideration of the available alternatives, for example, a me-too drug should be evaluated different from a drug to address an orphan drug with no effective treatment because the harms and benefits matter depending on how they fit into what's available. Often what's newest are the most needed and least predictable. And as we have heard, synthetic biology presents many uncertainties and unknowns, but also novel pathways to potential benefit. And we also know from the history of other novel biotechnologies, that benefit may or may not materialize. Context is individual and highly specific and case based, especially in a broad and variable field like synthetic biology. And we know there's always residual uncertainty in the application of science and its products, but assessing and balancing risks of harm and potential benefits in the research context is always different from doing so in the application of products that have come through the research trajectory. Now, uncertainty is going to be greater earlier in development, but it may also increase when a product or intervention moves from research to post-approval uses. The long-term individual public health and environmental affects of the introduction of a new intervention should also be considered and we know this from many current examples such as studies of drug metabolites and water supply and the cumulative effects of radiology from diagnostic imaging. Some things are uncertain and some things are unknown about every novel biotechnology. This is a really, really obvious example. Nobody in this room would disagree. But it's still extremely important to say we have to consider the existence of uncertainties and unknowns always. What should we be thinking of if nothing is new as it turns out. Some people have argued, including today, current developments in synthetic biology are really only incremental advances beyond novel biotechnological developments generally. If that's the case, nothing much really is new and harm-benefit assessment for synthetic biology is not going to be significantly different from that of other novel biotechnologies including, for example, gene transfer and genetic engineering, tissue engineering and regenerative medicine and nano technology. So how well are we doing now in these assessments and in working to minimize the risks of harm? Well, oversight of all of these related novel biotechnologies is young and really still evolving. Even the Belmont report acknowledges the difficulty of analyzing limited information to reach systematic nonarbitrary conclusions when assessing potential benefits of harm and research generally. And recent literature on harm-benefit assessment in research done by IRBs or in the scholarly literature discussing the meaning of minimal risk, recent literature shows that we're really still not good at doing this. Now, synthetic biology may be the most complex and wide-ranging of novel biotechnologies, but it's really nonetheless only the latest illustration of empirical and conceptional challenges we haven't fully addressed and appear more urgent eem time something comes along. What is new? Now, some people have argued, some folks today as well, that synthetic biology is different in kind from other new biotechnologies and probably more people say, well, it's not really different in-kind but it could be different enough in degree, either now or later, to become different in-kind. Now, the arguments made in support of significant difference either on the risk of harm side or potential benefit side includes some things that have already been mentioned, such as the rapid development of cheaper technology that's easier to acquire and manipulate, thus raising the possibility of basement biohecking, the capacity to work on a far larger scale and to combine technologies, thus greatly speeding process and the affect on individuals and the environment. A lot of developments are already being seen in genomics nanotechnologies and regenerative medicine. Maybe their's one novel factor which might be the argument that the engineering of increased difference is a safety measure. Now, a direct relationship between difference from existing interventions and potential benefits is, of course, the standard expectation in all novel technologies. But as far as I know, proposing that increased difference increases safety isn't an argument that is usually heard. So the attempt to ensure that biosynthetic organisms are compatible with the biosphere, unable to compete with bioorganisms or survive independently is an attempt to minimize risk of harm. We know increasing difference also increases uncertainty and the success at the attempt itself as we heard from Dr. Snow is uncertain. So this possibility needs to be incorporated into harm-benefit assessment. I'm just not sure how to do that. Another observation, biosafety and biosecurity systems are leaky. Now, biosafety and containment systems and practices have advanced a great deal in recent years, but there's really still a long way to go. We have clearly demonstrated this in gene transfer research and nano technology research and production and especially since the post 9/11 increase in biodefense and emerging infections research. For instance, there's only a limited number of biosafety level 3 and 4 labs in the world to do work that requires that level of containment or we think requires that level of containment. And the number of trained personnel available to work in high containment facilities is limited as well, which is a problem that's complicated by biosecurity concerns. A dual use concerns are ubiquitous and of long standing in many areas of research as we have heard from Dr. Venter, but we're really just beginning to develop good biosecurity measures to address them. Basically, in order to assess the risks of harm from intentional misuse, it's necessary to anticipate unintended risks of harm and yet the relationship between biosafety and biosecurity is to some extent still underexamined although both Dr. Venter and Dr. Church did getter than most in connecting the two. Moreover, restrictions on information sharing among scientists can cut in a lot of different ways. For instance, it could impair efforts to minimize risks of harm. Whether those restrictions result from the protection of proprietary information or from concerns about security. And coordinating and enabling effective monitoring and oversight of biosafety and biosecurity measures, for example, through NSABB and institutional biosafety committees also presents a real challenge. A final observation. Because nothing is new and everything is new, we really need to rethink uncertainty. When assessing harms and benefits, how do we know what works? Like, how do we know when we've actually gotten to something that is an improvement, that is beneficial? It's an especially relevant question when the anticipated benefits are unprecedented, whether those benefits arise from say, for example, regrowing limbs and organs from regenerative medicine and tissue generation and synthetic biology. If you have never seen something before, you can't necessarily measure when it's effective. Harm-benefit assessment is further complicated when a novel intervention moves from the research arena to being a product because then its scope of use widens, the population affected increases and diversifies. And thus its harms and benefits change. Part of the challenge of coming to terms with uncertainty lies in attempting to protect this expansion. It's necessary to recognize the difference on certainty, risks of harm and potential benefits all may increase together. And also that at times, obvious consequences may be overlooked. We have only to examine some of the best-known examples of risk materialization and gene transfer research to be reminded of this. So consider, for example, the well publicized deaths of research subjects as different as Jesse gelfinger or Jo Lee Moore and those with deficiencies who developed leukemia as their genetic disease was significantly ameliorated or their subjects in hemophilia trials showed viral vector in their semen even though their gene transfer injections were into their venous system. Each of these much discussed and exhaustively of risk materialization reflect the complexities of science, the frailties of human understanding and the difficulty of assessing and balancing risks of harm and potential benefits in very, very different context. Synthetic biology appears to present a similar degree of uncertainty at least. A lot of provocative language is used to describe both its promise and its peril. Unprecedented, dramatic, unique, the scientific and policy infrastructure that we really need to determine whether these terms truly apply I think really needs to be coordinated and strengthened. So two things that may be needed to come to terms in synthetic biology are some very long-term monitoring and continuous harm-benefit reassessment. This is something that we basically already no is needed from gene transfer, regenerative medicine and nano technology. And two things we need to work toward to address uncertainty in synthetic biology are an integrated system of oversight and collaborative harm-benefit assessment and discussion, with regard to individual and environmental effects and also with regard to social effects and health. We also know this from biodefense and emerging infections research, from gene transfer and from regenerative medicine. Fortunately, this commission is very well-positioned to move forward by fostering much-needed engagement with these questions for synthetic biology. Thank you. >> Thank you very much, Nancy. For those of you who weren't here this morning and those of you who were as well, I will just repeat it very quickly. We will be open now for questions from our commission members. And then I will open the floor to the public. And as is our tradition, I ask the vice chair if he would like to lead off with a question. >> I would. And, first of all, thank you all very, very much. Having read some of the positions, but hearing them expressed personally is especially helpful. I heard something that I want to bounce off of you. And that is that there may be categories within which we should approach differently this analysis and this benefit-harm analysis. I think I heard three categories. And I want you to comment if this is right. And the first of those is the work that's done in research, in the research labs. Mr. Thomas, you think actually said some things belong sequestered in the research lab. And the second category, the second and third categories actually make up what you call the bioeconomy. They would include the applications of synthetic biology in contained processes. And third the intention to actually deploy GE Os as you refer to them. It's three categories. Research, contained application, deployed, environmentally deployed application. Is that fair? Is that a fair categorization? Is that one way for the commission to imagine how it might explore addressing the different needs for benefit and harm? >> Jim, why don't you weigh in? >> It certainly speaks to the safety risks. And to some extent the socioeconomic risks and there's obviously a continuum between those three. You know, if research is being done to understand how organisms work, you know, we understand by building, we don't need to go beyond the research laboratory. It stops there. But if it's being done in order to develop a product and you have a certain amount of financial and political investment behind that, then it's going to move on to the contained use or deployment. Likewise, once you move into the commercial sphere, that's a very key line. I think it's not just the line or the lab door. It's the line between commercial use that's significant. I think maintaining a commercial environment containment, you know, is a nice fantasy. And it might work. But over the period of time, I think it's going to get lost. So I think we should think that any commercial use is going to end up being a kind of deployment because there will be unintentional escapes. So I would draw more useful line between research and commercial use. >> Allison. >> Yeah. I think those categories are very helpful and perhaps your committee could think about do you have any concerns about basic research that is in synthetic biology. And that has been covered quite a bit more than these applications that are still very young. And the applications involve the bioreactors in the field. So if you feel that the basic research is appropriate and being done, you know, under the best intentions or however you would address that, that could be a separate category that you would look at from the others. So I think that's quite useful the way you have described it. >> Yes, Dan. I'd like to ask a little bit about the current status of environmental impact assessment because my understanding is the usual way it works is there are theoretical concerns and theoretical safeguards. And then we release it to the environment and then monitor as Nancy was saying. And then sort of hope for the best. But I wonder whether things have evolved to an experimental basis for doing this, which is often very difficult in ecology, somewhere between isolation and released in the environment. So there could be a more rational basis for assessing whether certain modifications and organisms are in fact effective, if those genes are transferred from one organism, etc. What's the state of assessment? >> Allison, we'll start with you. >> My familiarity is with genetically crops. And you start out with lab experiments and work towards small-scale field releases that require approvals from the federal government and then sometimes there's a larger scale field release and then you're out. Basically, the regulatory agencies have a real tough job making those calls because they never have enough information. And I think you'll hear a lot more about that tomorrow. Meanwhile, ecologists and environmentalists are throwing out their opinions all the time and so are other people. And so there's a lot of debate and discussion. I think that the regulatory system has worked quite well in preventing terrible ideas from going forward. So all that discussion and those stages have been quite effective so far. I just don't know if we can keep up with the pace of change that's happening now and into the future. >> Interesting. Nelson. >> This is probably more directed to Mr. Thomas. I travel to Kenya frequentry. My program has a very large HIV/AIDS care and treatment program as well as research activity in the western highlands. And that country, as you probably know, to use an example is burdened greatly by diseases of poverty and diseases of pandemic nature. So if you look at Nairobi which is surrounded by a huge influx of very poor people in the caberra slum, they have come there because they basically have been seduced away from sub sis tans farming which worked to come to the promise of working in a place like Nairobi where they have become an at-risk population. Described the potential hazards of synthetic organisms in terms of toxins, ecologic damage and impact on risk populations. The current trajectory of what the state of the world is right now, these are all issues that are in play. And there's great suffering in that part of the world just because of the fact there isn't clean water. There aren't the provision of inexpensive therapy. There's essentially no middle class. The subsistence farming has been influenced by the cash crops that largely go outside the country like tea and flowers. So what I'm trying to understand is what your current view would be on a tool like synthetic biology, and what would the constraints be that you would see to potentially use the tool. Things are bad the way they are now. If a tool has a promise of making things better, agreed there are lots of uncertainties. But how do you balance the views that you very articulately put with, I think, frankly, the real-world suffering, as you speak? >> I don't know the situation in Kenya, so I'm going to talk more generally. Obviously, the move away from rural livelihoods to being pushed to the cities happens all over the world. And it's definitely causing, you know, a number of problems. Your question says we have a deeply unjust situation in places where people have been pushed off the land they have sub sissed on for a number of reasons. Maybe we can use this tool to ameliorate their positions. I would suggest if we start with the problem and how we address the problem, we would be looking at things like land reform. We'd be looking at things that would allow people to return to land that's been taken from them. And when I look at where the bioeconomy is going, there are large amounts of land that are going to be required to grow biomass feedstocks, for example. That's going to exacerbate those root causes. So yes, there's an interesting discussion to be had. Can we use these tools to ameliorate people's suffering, given that they have been pushed off of their lands? And but shouldn't we be trying to prevent further dispossession of land? And it's not a small issue because the idea that the bioeconomy is going to find marginal lands where it can grow biomass but doesn't get used is entirely a fantasy. Marginal lands where people now live, having been pushed off of better lands. And the new bioeconomy is going to end up in the first phase consuming the old bioeconomy. People already use firewood and they use wild crops and so forth. And that's what's going to get displaced in the first instance. So unless that root cause is addressed in how this economy develops, then using the technology to throw life lines is just going to be chasing after the problem. So yeah. There may be uses and vaccines here and so forth that are useful. But if you at the same time expand in an economy that is going to worsen the original problem, then I think that's counterproductive. I don't know if that answers your question. >> Define whether or not you believe this tool is incapable of ever being used for any -- or your concerns are just that we should take a measured approach to consider its possibilities since largely it's unknown. >> The question there is who are we that if you are talking about the use of synthetic biology to improve the situation in Kenya or Brazil, wherever, that discussion has to involve the people who are most impacted. It's not that we sitting around a table in Washington to determine the most appropriate use of the technology or whether the technology is the right place to start to address those problems. If we're going to have that discussion, those communities need to be here at the table. I don't feel that I can speak to that. >> John. >> Thanks again for another terrific panel. I wanted to address Jim Thomas with a question. As a pormer Peace Corps volunteer, I appreciate you bringing the concerns of the global core to the table here. I'm sort of puzzled about what your bottom line is. And in particular, I'm puzzled about exactly how that sort of a prohibitory policy will actually work. So toward that end, can you help us by naming historical analogies where technologies have been prohibited successfully for long periods of time. And can you think of a -- can you think of developments in any science where basic research has flourished and been supported by government and so forth without sort of leaking out into the economic domain as well. >> Technologies that have been taken and turned around and been prohibited, land minus -- mines come to mind. There are land mines in existence but there's a process in place to try and remove them. Yes, it's true. It's very hard to find examples of technologies and sciences that moved ahead without commercial and establishment and support. History, you know -- it's hard to see what didn't happen in history sometimes. And I think what this points to, though, particularly as technology and science becomes ever-more important to the questions of development and questions of environmental sustainability, we need to have processes in place where we can have those discussions before it's too late. And that's -- yeah, I agree. That's a new thing. I don't think we invented those procedures. I think there have been attempts. The Swedish government had something called seesta they set up with an ability to develop technologies to see they were socially appropriate. Seesta got put to sleep. And some of the mechanisms, whether the center on transnationals or the Office of Science and technology here have also been put to sleep. We need to develop social technologies to assess our technologies. And in a way, we were hearing earlier about the gap between our abilities to synthesize DNA and ability to design, I was reminded of Martin Luther King's words that the gap -- I think he talks about between the state of our wisdom and the state of our abilities, we have misguided men and guided missiles. The point being we haven't put enough effort into developing the social technologies to assess and govern our technologies. And that is where I'd like to put money and effort, time I think. This commission could suggest that. >> Christine. >> First, I want to add my thanks to all three of you. Wonderful presentations. I want to direct my question to you, Dr. Snow. You had mentioned -- I understand the concern about things that are environmentally released. But you had mentioned the things like suicide genes and other techniques that might be built in to limit the possible damages that are created from these released substances. I am wondering if this particular area has a unique opportunity in that regard, to develop either suicide genes or chemicals, whatevers, that make things destroy after a while. And because it's synthetic, because we're synthesized and if we could build those things in as part of the trajectory early on in the research stage and as Nancy said, carefully assess them in the research stage, reassess them later, but, you know, have as a sort of bottom line always there needs to be something built in that will destroy this thing if it gets out of hand. What do you think about that? >> I think that's a really interesting angle and there should be the potential for much more effective biological containment or refinement. Probably a company like synthetic genomics could provide data on how accurate and how long lasting it. There would always be people that would say maybe it could break down but maybe way better than anything that came before. But another issue is that all companies aren't going to be that responsible. And there's going to be so many people in the world doing all kinds of experimentals that are still a concern I think, even if you have the ability to do it. I think that's a good point and there's research going on to try to develop those type of terminator type technologies for new organisms. >> Yes, Jim. >> Could I speak to that? Because our organization came up with the word terminator technologies and I think it's important before suicide genes to look at the reason they were originally developed. Terminator technology was originally developed in order to enable large companies, mon Santa, Delta pine lab and so forth to control seeds so they didn't get reproduced by small farmers. To exercise control of the monopoly of agriculture, particularly in the south and developing world, taking away the rights of small farmers, the very essential rights. And although now there's a discussion about whether we can use that technology for biosafety. It has to be remembered this technology is extremely interesting. Two large companies that want to maintain monopoly has dual use implications. If you can have genetic switches, you can turn on and off traits from afar. And that could be used for a bioweapon. It would be dangerous to acknowledge that it's going to get used for monopoly and other ice uses. There is an international moratorium on the use of technologies through the conventional use and that shouldn't be overturned lightly. That should be respected. >> Nita. >> Thank you. I was particularly interested in your comment about resource limitations. But like John, I want to kind of press you a little bit on what your bottom line is. You call for a moratorium on the release of this synthetic biology into the environment. And yet I'm not sure how you could ever get comfortable even post the moratorium, particularly if the terminator technologies are ones we shouldn't be endorsing and as professor Snow said if they are through future generations self-replication could be overcome. I was wondering if you could get comfortable if the moratorium is initiated or calling for a ban on this technology entirely. Professor King, you mentioned long-term surveillance and monitoring once we release the technology could be effective. What if professor Snow is right and if there's any sort of terminator technology built in, they are simply overcome by, you know, the process of replication. Is that really an effective strategy to do surveillance or long-term monitoring if there's no containment possible? >> I think I understand your question. Asking for a moratorium, are we asking for a ban? >> Yes. >> There are bigger concerns based on the economy that would flow from this than the justice questions. But I think this points to questions about democracy and technology and if there was to be a way of truly governing our technologies so there was a Democratic ascent. And we don't have the social technology to do that. Then, you know, through that process, people in Kenya, people in the south, particularly who are going to be most affected, say actually we need this technology, well, yeah, maybe that occasion. >> Jim, could I just ask you very simply? We don't have a Democratic way of ascent to it. But neither do we have a Democratic way of banning it. >> Yeah. >> Doesn't that argument work both ways? >> I think there is a larger problem here about the lack of Democratic control over technology and science. And, you know, whether it's synthetic biology or synthetic Geeio engineering. >> That argument proves too much and too little. >> Yes. >> There was another question, the same question to Nancy. >> Well, this was a question with respect to does long-term monitoring really matter if containment turns out to not be possible. Well, I think the reason I mentioned long-term monitoring really is that we haven't done it for any technology. And most of my experience is with gene transfer research. Long-term monitoring of the effects of gene transfer on research subjects and even viral shedding, which everybody was worried about at the beginning of gene transfer and got less worried about, hasn't really been followed. I mean there isn't the funding for it. It simply isn't being done. Most gene transfer, though they do use suicide genes in gene transfer research as well, most gene transfer, you can't undo the effects. We don't know what the long-term effects are. Even if containment weren't possible, it seems to me to make a lot of sense to start doing long-term monitoring so that we can simply see the effects. After all, I mean the ecology is sort of a moving target anyway, even if we can't contain, if something needs to be done, we can't figure out what it might be unless we know what the effects are. >> I'm going to see if there are any questions from the members of our public. We're going to move on to the next session without a break, so I'm going to take five minutes. Please come up to the mic and introduce yourself. >> Hi. Owen Shaffer. NIH. I had a question for Jim Thomas. Sorry you get so many, very but interesting comment. It was about the examples which you gave of the two examples in particular that struck me. The Brazilian I guess sugar slave example and then the problem of farmers losing their competitive edge. These seem like the problems of not only synthetic biology and the modern economy, don't these problems seem intention of each other? In some way the solution to one pauses the problem of the other. The sugar slave situation, we don't have production in these areas, but then you have members of the farming community in Brazil which no longer are able to sell their sugar at the right prices. On the other hand, if you have the farmers and you want to say we're going to increase our purchase of food from all these farmers in third-world countries, then you end up with creating this problem of human rights abuses in these areas. How do you -- it seems it doesn't matter what you do. You're going to end up with human rights abuses in these situations. Seems like there isn't a solution. It's not synthetic biology. It's the modern economy. >> Sugar production in Brazil is highly concentrated and it's very large companies. You're talking about a power structure where large companies are hiring migrant laborers close to slave conditions. Talking about east African farmers, you're talking about small farmers, admittedly, still poor farmers. And yeah, you're right. We are pointing to the real disparities in terms of the rights and livelihoods of people in the global south that's going to be affected and already affected by the global economy and going to continue to be affected by these changes in the global economy. I think my point is that, is synthetic biology going to improve the lives of people? The largest majority of people in the world. I don't think it is. And therefore, I would wonder if that's the direction we want to be going in our technological research. >> Yes. Up to the mic, please. Thank you. >> Hello. I'm sussan Poland. And I would like to speak about from my experiences at the Jones institute for reproductive science in Norfolk and my experience at the Kinsey Center for Bioethics comparing embryo technology to synthetic biology. The common issue to both is actually reproduction, whether you call it creation or cloning or booting up, it's still going to be reproduction. And there are two common concerns. One is control on growth and on cessation and growth. And the other one is implantation which this group has been speaking of mostly as containment. And the implantation or release has to do with context to the body or with the environment. I went to a C.D.C. conference in 2002 in June right after the SARS epidemic and the Canadian delegation stood up and spoke about controlling and actually how the SARS epidemic came into Canada and then went through Canada and everyone stood up and gave them a standing ovation because we realized that could have been us. And they said the one thing that they did was a lost opportunity with the SARS epidemic and that was to educate the public about the difference between infectious genetic disease even though we had already gone through AIDS. This group and my question is through Dr. Gutmann and Dr. Wagner and maybe the whole group, based on all previous experiences, who has the ethical obligation, who has the legal responsibility to educate the public about science. Which public? Are we talking about a blue ribbon public already well in this area that knows to come to this meeting in the middle of July? Or is it the public that are the people reading their summer reading lists out there? It's more inclusive. Is this a passive obligation? Is this an active obligation? In the past, I've seen it be very passive. No, the scientists have to go out and do it. Is this a public obligation or a private obligation? To this end, you have an opportunity just like the people did with the SARS. Right now, you have six months, three meetings, school time starting in about another six weeks when my work ends at the Kennedy institute by the way. And in that time, you could put together a very short unit for all the biology teachers throughout the schools explaining to these kids how synthetic biology works, what the tools are. And they can go home and talk to their parents about it and start thinking about their science fair projects about ethical obligations or whatever. This is your window of opportunity. And my last comment has to do since I've written on bioethics, councils, commissions and committees, has to do with an inherent conflict between the global nature of science and the national nature of regulation. And as an American advisory body, this group can make recommendations that work, such as the Nuremberg code or better yet the Helsinki accord, and we're talking more than about medical science. You can set a model that can be adopted or adapted, depending on each country that will be used by regulatory bodies worldwide. Thank you. >> Thank you very much. You asked some questions there to Jim and me. And I will give a very -- my very brief answer without the reasons behind it. The responsibilities are widespread, including the responsibility of this body, to do our job as best we can to publicly educate after hearing both from experts in the field and people like you who have really legitimate concern about what's going on, number one. Number two, you asked whether our responsibility was passive or active. It is definitely active. We have done our very best, even having a meeting early in July, despite the fact it's the summer to get the word out and really invite the public. And we will be meeting around the country. We are a body constituted by the President of the United States and, therefore, our first obligation is to do outreach to the American public. But these are open to anybody who wishes to attend. So second, active, not passive. And third, it is a public and a private responsibility. I think it would be a mistake to say this was just the public possibility, although it is first and foremost a responsibility of the public. But private bodies also have ethical responsibilities here. Thank you very much for that. And I'm going to ask Jim to add something to that since you addressed it, to both Jim and myself. Then we will move on to the next session. >> More broadly, I would agree with you that it's probably within the scope of the report of this group to make some recommendations about education and the dissemination of information. Science literacy we know in our country is not even what it used to be. When you ask who is involved in that, well, as Amy has said, it's a broad responsibility. Yes, educational institutions can be involved. I think it's fascinating to look at the fourth estate and journalism and how journalism has changed its mission from the time where we had so much science education through journalism during the space race, for example. And that is gone now. So much of that is gone. So perhaps your contribution to our deliberations today is to ensure that somewhere in our report we make recommendations about public education. Thank you very much for that. >> And I want to thank on behalf of the commission our three wonderful presenters for lucid, informative and provocative information and recommendations. Thank you all very, very much. [APPLAUSE] >> Let me invite Dr. Kaebnick and Dr. Buchanan to come to the table. We're not going to take a break. We're hardly going to breathe as we move into the fourth and final panel of the day. As they are getting in place, the fourth panel deals very specifically with ethical issues of synthetic biology. Our commission is, of course, ultimately charged with looking at these ethical implications so we have two different panels of speakers, one today and the first one tomorrow to help us focus on these issues. We have asked the speakers of today's ethics panel to tell us what they consider to be the most important ethical issues raised by current and foreseeable developments in the field, to help us understand if we have already or how much we are in danger of crossing any ethical boundaries owing to the unique methods and applications associated with synthetic biology and not common perhaps to other scientific endeavors. Welcome to both of you. And our first speaker will be Dr. Gregory Kaebnick, a research center at the Hastings Center, coinvestigator in a research project on ethical issues in synthetic biology funded by the Alfred P. Sloan foundation. Dr. Kaebnick, welcome. There's only room for so many words in my brain, unfortunately. It's really great to have you here. Look forward to your presentation. >> Thank you very much for inviting me here. It's a big honor to be here. So my goal, my charge, as I understand it, is to set the table for these next two sessions in these two meetings by giving you an overview and also comment on how these issues might translate into a governmental response. And I should say both by way of giving credit where its due and by way of offering a kind of caveat, that what I'm going to say is informed by and comes out of this Sloan-funded project you mentioned. But it's not anything like a consensus statement of that body. We have brought together a lot of people and I have benefited from a lot of input. I'm certain that not everyone would participate and sign on to what I'm going to say here today. Anything I say that is particularly silly is very much my own. So I group ethical issues raised by syn biointo two categories that perhaps runs counter to one of the premises of this session essentially. One of these has to do with whether synthesizing organisms is bad in itself, intrinsically bad aside from the consequences for human welfare. But the other set of ethical issues does have to do with these consequences. When I talk about the ethical issues, I mean to have both on the table. The harms and benefits as well as the intrinsic concerns. I'll start with the intrinsic concerns which is what our work at the Hastings Center has to date focused on. I believe these come in related, but different forms. And there are related, but somewhat different things to say about each of them. First off, maybe the classic way of articulating concerns about synthetic biology suggests a kind of religious or metaphysical claim. One might worry, for example, that synthetic biology puts scientists in the role in the COSMOS that would be properly held by God. Scientists are playing God is a phrase we have seen over and over again on TV about this. Or slightly different point, one might hold that synbio has an inappropriate degradation of life. Prince Charles seems to have something like this in mind when he lamented that biotechnology was leading to the industrial of life in a capital element. My guess, though is that people mostly don't view the question of what humans may do to life as sort of this single uni tarry. Sacredness might be attributed to some but not all living things and synthetic biology in its current form, though we have heard a little bit and there's been some in the media but getting human reproduction under control, synbio is what we can do with microbes. If you did object to synbio along these lines, it would turn out to have fairly limited force in the public sphere. It's an objection that cannot be fully articulated without appealing to one's faith or world view. Not everyone will share that world view. In fact, we know from one of the readings sent around for this meeting, not everyone would share the objection within the faith of world view. Some will celebrate science as an aspect of human creativity that we are meant to develop and put to use. Finally, there is also an important question whether this kind of concern may legitimately ground public policy in a liberal society. Governments in liberal societies are widely thought to have to maintain some level, some kind of neutrality concerning religious belief. They shouldn't be forced to believe. If I can just offer a little side note here. Some thought the NOI in May that a synthetic cell had been created established once and for all some of the religious world views are false. They climb science that is finally definitively shown that life is just a well organized puddle of chemicals. There's no greater being, no spiritual core and no vital essence by which life is sacred. I don't really see how that reasoning goes. I don't think that's quite right. Seems to me if there's a god who gives microbes, even microbes, some special vital essence, it would be well within that God's powers to endow a synthetic microbe with vital essence as well. A somewhat similar question came before one of the predecessors to this commission, the national bioethics advisory commission. Whether people created through cloning would have souls. Submit that it's extremely difficult to resist the conclusion that they would. And by analogy, it seems that microbes created in the lab would have whatever special soul-like properties there are that characterize microbes generally. Another way to develop intrinsic observations to synbio would be to couch them not at metaphysical claims but as concerns that the field somehow conflicts with important moral conflicts. A number of commentators have suggested that synthetic biology my conflict with the concepts of human agency and life and maybe it promotes a kind of grandiosity about human powers or dismissiveness about the specialness of life. These are sort of low-key versions of the metaphysical claim of human beings in the cosmos of life and what some may see as grandiosity some may see as commendable inventiveness and desirable industry. Also the fact that an organism has been created in the lab doesn't necessarily settle what its moral value is. This also was a point offered in the readings. And finally, again, synbio is still about life and deeply implicated by what we do, as long as we're just doing it with microbes. Another more promising way of saying that synbio conflicts with shared moral concepts to hold it raises questions about the human treatment of nature. To see it is an environmentalist concern. A goal of environmentalism isn't just to make nature a safe place for human beings but to make nature safe to some degree from human beings. We should treat the natural world with the kind of acceptance or even reverence and that seems to saving endangered species or wildernesses and forests and so on. Maybe synbio doesn't square quite with this value. The obvious rejoinedder is that human beings have been altering nature throughout history so the issue has got to be at the very least where to draw the line, even determined preservationists will accept that there's some sort of balance to be struck between protecting trees and harvesting them, so there might also be a balance when it comes to biotechnology. Furthermore, many, at least of the nearer term, potential synbio applications are fairly limited from an environmental standpoint and could be if they worked out right. In many cases, we're not talking about intentional ecological changes. We're talking about creating limited microbes to be contained in a laboratory or factory and would maybe partially displace the petro chemical industry. The classic concerns about the human relationship to nature are about environmental destruction. The demolition of species in wildernesses. Part of the promise any way of synbio is that it will be beneficial to the environment. If that can be achieved and note the conditional obviously, many environmental Is might find at least some applications of synbio aattractive. And I mean this actually from the standpoint of intrinsic values. The kind of deliberate release into the environment that professor Snow was talking about would be another category of protection. So my concluding thought about the intrinsic concerns, I take them very seriously. I'm not inclined to write them off at the outset as illegitimate, as many people with my kind of degree are. But I think that once we study them, they don't point toward a need to restrict synthetic biology. Not now anyway. It seems possible that the intrinsic considerations would change as the details change. If environmental damage looked to be likely or if we began to apply the technology to complex organisms. The second category has to do about the consequences. I'm not going to talk about what these are in any details. So these are more economy at that than I. I want to say a little bit more about the process of assessing them, a conversation that was begun in the last session about professor King. An overarching point I want to make, there was a legitimate question whether current strategies for evaluating possible outcomes are actually up to the task. As has been stressed especially in the last session, the potential benefits and risks of synbio are particularly difficult to assess. It's very easy to be dazzled by futuristic stories of how technology is going to remake the world for the better. It's hard to think hard about the kinds of risks, kinds of potential harms that synbio presents. Some of these appear to me to be very low probability, but very high impact, which is a confounding for us. We blow risks out of proportion. We also weigh them too lightly as happened to very bad effect in the Gulf of Mexico, nor is it clear as many have stressed now how much we can learn about it the risks of synbio with older biotechnologies. Synbio is on a continuum with older work which can be seen as a form of the older work and significant advance on it. And frankly, the testimony at the house energy and commerce committee on this point in May tended to make both these points, emphasizing the respect in advance when discussing the benefits and the familiarity when discussing the harms. Second, we have to negotiate this tension between benefits and harms, sort these out, just as their a debate going on about how to assess technologies, how to weigh benefits and harms. This debate is basically over the approach known as risk assessment and cost benefit analysis on one hand and the precautionary principle on the other hand. One side favors objective scientific and economic analyses, tends to down play the enormive assumptions it makes as when applying a discount rate to future risks and benefits. And according to its critics anyway, it gives too much weight to potential benefits. The other side invokes an expressly enormive stance and according to critics gives too much weight to potential harms. The point I want to make, there are at issue here a series of difficult questions about values and how to operationalize them and it's easy to bury these decisions and equations without really attending to them carefully. I think a good public assessment of synthetic biology ought to be ex-ples it -- explicit to these and open to reassessing them. So in conclusion, I think a case can be made for pushing the field forward. I think there's also reason for caution. I think we should guard against overconfidence in looking at the outcomes. And I'd offer four general recommendations. I think we need much more careful study of the emergent possibility and the impact of the potential harms. I think we need a strategy that is grounded in good science, is flexible enough to look for the unexpected. I think we need a strategy for studying the risks that brings together different disciplines and different perspectives on the risks. And I'd add that is clearer about the enormive assumptions at stake. And then it seems to me that then we need to go on and on the basis of that conduct an analysis of whether our current regulatory framework is adequate to deal with these risks and how that framework should be augmented. And, of course, the sessions tomorrow will carry that forward. Thank you. >> Thank you so much. Our second speaker is Dr. Allen Buchanan who is Duke's university distinguished Professor of Philosophy and investigator for the university's Institute for Genome Science and policy. He's also a distinguished research associate at the Uehiro Centre for practical ethics at the University of Oxford. He's worked on or been consultant to past bioethics commissions. He's a veteran. >> Very happy to be here but I haven't been equipped with any means of changing the slides. >> We would like to remedy that. >> It's going to be a problem. >> In the meantime. >> There ya go. >> I'm having a feeling of deja vu. 28 years ago, I was working on the first president's on genetic testing and the other on splicing life, genetic engineering with human beings. In a moment, I'm going to explain why I'm a little depressed because I think some of the language used in the debate about synthetic biology is depressingly similar to some of the language used 28 years ago. I think we need to get beyond that language and the prime suspect here is talk about playing God as Dr. Cade knick has pointed out. There's lots of better ways of talking about the risk of unintended consequences and the risk of overreaching our knowledge than using these slogans like playing God. I'll say we a number of times during this presentation. It's because I'm presenting work that was done by myself and Russell Powell who is actually at the back of the room here. An earlier speaker said that he was wearing a button that said it's the bioeconomy stupid something to remind him of that. And I'll wearing a tie that depects the anthrax pathogen to remind me of a point that will come up later on. [LAUGHTER] Well, let's see. What should the commission do? Well, obviously, we should consider the benefits. And this seems like a no-brainer. But I think that with some past Presidential Commissions, including the last one, there really hasn't been a sympathetic enough explanation to the public of what the full range of potential benefits of new technologies has been. And this sort of stacks the deck because people are very aware of possible risk, but the potential social benefits of synthetic biology need to be thoroughly explored, both in terms of advances in basic sciences and in practical applications. And this last item on the list there is something that's come up a couple of times. Namely, it's important to determine which benefits can only be obtained or only be obtained at reasonable costs through synthetic biology. Because I think that's going to be very relevant to trying to weigh risk and potential benefits. There needs to be a classification of the risks. It's not productivive to talk about the risks in the blanket clumping way. The comprehensive classification needs to try to distinguish the severity of harm, probability of occurrence and immunability to management of the risk and in particular to try to determine which risks, if any, are peculiar to synthetic biology. And it's been suggested earlier today in a couple of talks and comments that there are perhaps peculiar risk of synthetic biology because of the technology is so easily accessible and people can order nucleotides and buy gene synthesizer or use the services of one. They can download the information from the Internet. Well, again, I'm not sure that's so different because 28 or 30 years ago, people were saying exactly the same thing about gene splicing. It was incredibly easy. And in one sense, they were right. I'm not convinced that there's an order of magnitude difference with synthetic biology, at this point at least. In tems of ranking the risk, in our judgment, the most are the risk of unintended bad consequences which people talk quite a lot about today and the so-called dual use risk. Now, the other supposed risks have been mentioned by Dr. Kaebnick and they include the so-called playing God idea and in a moment I'll say why I don't think that's a productive way to label that risk. Worry about devaluing life which Dr. Kaebnick also talked about. And the idea of encouraging unwholesome attitudes toward humankind's relationship to nature. Now, there are in fact two dual use problems, not one. First is the one that everybody talks about, the risk of misuse of synthetic biology by bad non-state actors or rogue states. That's very important. But there's also dual use 2. The risk of quote, good governments using synthetic biology, including research and techniques developed in antiterrorism or defensive bioweapons programs for offensive purposes and the risk of so-called bioweapons arms race. I think it's important for the commission to squarely admit this is a risk and also to admit that efforts to reduce the risk of dual use 1 may not be effective for dual use 2, but they may actually exacerbate dual use 2 risks. Let me just mention something to try to bring home this last point. Look, if you have a big antibioterrorism initiative to try to reduce dual use 1, the first effect is you're going to be training a lot more people who are capable of doing bad things with the technology. The second risk is that you may be creating government agencies which will in their function of doing surveillance over new research will be in a position to get hold of that research, use it for their own purposes and restrict everybody else from using it. Now, I mentioned this point at a meeting on antibioterrorism initiatives a few years ago in Baltimore. There was a member of the NSSAB there. And he said, oh, you know, professor Buchanan, I don't mean to be impolite but you're being paranoid about this dual risk 2. I asked him if he had read the president's advisory commission report on human radiation experiments. He said he hadn't. And I suggested that he should read that before he commented further on my paranoid tendencies. I served on a staff commission and a couple of people in the room worked actively on that. And for those of you who aren't familiar, this is a very sad story of pernicious complicity between leading figures in science and the U.S. Government conducting grossly unethical experiments over a period from about 1944 to 1973. And they were people just like you and just like me. So I think dual risk 2 is something we really need to think about and don't just focus on dual risk 1, although dual risk 1 is extremely important. Now, I don't want to try to assess what the risk of bad unintended consequences is. I'll leave that to people who have more technical expertise than I. But I want to suggest that there are good ways of framing that problem and bad ways of framing it. And one bad way of framing it is to rely either explicitly or tacitly on very misleading metaphors about what evolution is like or what nature is like. People talk about the benevolent balance of nature or in President Bush's report biotherapy they likened natural selection or evolution working through natural selection to the work of a master engineer that produces complete, stable, harmonious master products. Now, from the standpoint of evolutionary biology, this is just bunk. This is not what evolution does. It produces Jerry rigged contraptions that respond to short-term design problems with no forethought for what will happen down the line. And at most, it fleetingly proximates biological fitness. Human well-being is not about biological fitness. We have goals in life that are a little more ambitious than maximizing the number of genes we pass on to the next generation. The problem as I see it is that to a large extent, the public and even many members of the bioethics community have a few of nature that's really preDarwinnian. It's a view of nature as this kind of stable, harmonious largely benign thing. And if you have that view, you will automatically stack the deck against any biotechnologies. You will automatically think that the situation is like this. Everything is humming along just fine. The status quo will continue indefinitely, so long as we don't intervene and mess it up. That's simply not true. As Dr. Venter pointed out earlier, we have already intervened in this planet quite a lot. We have created a lot of problems. We're not just individuals who react with preestablished niches. We create niches. We are constantly changing the environment. And we create problems. And some of those problems we may need synthetic biology to cope with. We can't know which and we can't know whether there are other means but we have to keep that open. I'm not making a pitch for let's go to be synthetic biology full throttle, yahoo. Instead, I'm saying it's very important how we think about the status quo. And part of that is how we think about nature or evolution and our relationship to it. And my sense is that this commission could do a huge amount of good by educating the public and the bioethics community with a more accurate scientifically informed view about nature and evolution. Now, another point, in managing the risk -- of course, the idea is to manual, not to eliminate risk. Life is not riskless. There's no way to eliminate risk. You need to emphasize that risk reduction is costly and often the marginal costs of risk reduction are rising. That is, additional incrementals of reduction of risk may come at great cost, including the opportunity cost of foregoing benefits that you might have. In terms of institutional design, it's very important in thinking about how to develop practices or, as one of the previous speakers said, social technologies for dealing with this biological technology. It's important to think in terms of institutional design and to note how different incentives apply to different individuals depending on their roles and these incentives can lead them to overestimate or underestimate risk and the cost of risk reduction. It's important to develop cautionary rules of thumb and practices that have the following characteristics. They are knowledge sensitive. That is, we should expect them to change as our knowledge changes and our knowledge increases in particular. Our way of approaching risk should encourage relevant knowledge acquisition. It should take the costs of risk reduction seriously. It should have effective provisions for ongoing critical revision of risk assessment and management practices. And it should not rely on a single risk reduction or prevention principle. Especially for het a hetero genus biology. Now, if you want an example of a cautionary heuristic or risk reduction principle that violates all of those, think of the precautionary principle as it's usually formulated. It's not knowledge sensitive. It doesn't encourage knowledge acquisition. In fact, it discourages it. It doesn't count the cost of risk reduction at all. It doesn't recognize that our situations are dynamic. It doesn't have provisions for ongoing critical revision of how it assesses risk. And it commits the fallacy of thinking there's a magic bullet, a single principle for all the hetero genus areas in which risk may arise. Now, a lot of this has already been gone over today so I don't think it's really important. But let me just mention one thing. Some people think -- and I think this is not unreasonable -- that there may be greater risk to synthetic biology because you may be creating a really novel organisms. And so they worry about the sort of virgin population problem in the case of infectious diseases. We don't have resistance because this is really new. On the other hand, I think there are a couple of considerations on the other side that need to be taken into account. One is that in general, dangerous biological agents like pathogens like the anthrax pathogen coevolved with their prey. So if you have something that's really, really different, it may not, as it were, have a purchase on us. It may be a more matter of ships passing in the night. That's another consideration to weigh in. The other is something mentioned a bit earlier also. And that is the very fact that you're creating more novel organisms, starting with more basic building blocks, means that you have in principle the opportunity to design in more safety features. You don't have that with less radical technologies including sort of conventional genetic engineering. You can do some things by regulating expression of genes. But synthetic biology, at least in principle, you have a wider range of opportunities for risk reduction by designing risk reduction factors into the product itself, rather than trying to provide fences and safeguards after it's developed. I think that's worth thinking a lot about. Now, this is something that Dr. Kaebnick mentioned also. And that is in thinking about risk benefit, cost benefit and cost effective analysis, it's very important to recognize both that these are valuable and that what their limitations are. There's been a lot of work on what their limitations are. And I think the commission could do a great deal of good by helping to educate the public about both the usefulness and the limitations on the usefulness of these risk assessment technologies. Also, I think it's very important to point out that taking consequences seriously doesn't mean you're adopting what moral philosophers call a consequentialist moral framework. There's a lot of misleading talk to that effect in some of the bioethics literature that needs to be dispelled as well. I'm not going to go over thereth -- this because I think Dr. Kaebnick did a good job of it. It's two degree indications. I really think it's the second version that we need to worry about. I'd like to dispense with talk about playing God because it's so ambiguous and misleading. Also I think if you ask people doing this kind of work, whether playing God, they will say they are not playing at anything. They are deadly serious. Now, what about this idea of humankind's relationship to nature? Well, again, I think we need to avoid misleading metaphors about the living world and talk about the wisdom of nature, benevolent balance of nature, master engineer of nature or talk about genetic pollution or breaching species barriers, all these are very loaded terms. And they are not really conducive to a reasonable assessment of the risk. They get in the way of a reasonable assessment of the risk. Here's another example. This last item. Beware of controversial enormative assumptions being smuggled in under the nature or human nature or nature. I have worked a lot in the ethics of enhancing normal human capacities by biotechnologies, biomedical enhancement. And the debate there has been infected by veryishy and prejudicial talk about not interfering with the natural, not destroying human nature. And all of that talk needs to be translated into more hard-headed concerns about risks and benefits. It doesn't help. I mean anybody who has looked at the sad progress of the concept of human nature over the last several hundred years knows that some of the best minds have said foolish things about what human nature is and isn't. It's a huge ongoing debate. And instead of smuggling in your moral premises under the supposedly neutral heading of a description of what human nature is, it's much better just to confront these moral issues. Again, that has to do with framing. So let me just -- I tried to go even more quickly than the other speakers. And I'm able to do that because so much of what I said has already been covered. Let me just make one last pitch summarizing. I think the two critical issues are the risk of unintended bad consequences and the two -- not the one, but the two dual use risks. And I really would like to see the commission focus on those issues and rather quickly set aside but in a respectful way towards those who still hold these kinds of views what Dr. Kaebnick referred to as the more intrinsic concerns. Let me just -- it may sound a little harsh, the last thing I said. Take the idea of creating life or of, let's say, reductionism. In your briefing book, there was an article by Cho et al. on synthetic biology and ethical and concerns and raised the concern about reductionism. Many people worry that synthetic biology is going to show that life is nothing but a bunch of molecules or something like that. Well, that's a misunderstanding of what reductionism is. There are a number of different senses of reductionism. No matter what you are able to do with synthetic biology, it's not going to tell us that we're not really moral agents. It's not going to tell us that there's no such thing as wrongness and rightness. It's not going to tell us that there's no meaning of life in any sense of the phrase meaning of life that we're interested in. And I think the commission could do a really good job of pointing this out and then moving on. Moving on to the real questions about unintended bad consequences and the two -- not the one, but the two dual use problems. And thinking about what sort of concrete recommendations can be made both to move the handling of the safety considerations forward and to help educate the public how to think about these issues better. And for today, in terms of the safety issues, the concrete issues of reducing the risk of harm, there's a lot that can be done. Commission Farahany has pointed out we need to think in terms of prohibition and in terms of licensing and tracking and surveillance. And as Dr. Venter said, engaging people in certain kinds of synthetic biology work to have institutional affiliations so that there is some kind of oversight and control. This is what we need to do. And we especially need to do this at the international level. Otherwise you'll have unregulated research in countries that aren't going along with an effort to make the technology safe. >> Allen, I know the commission is dying to ask you a bench of questions. >> Perfect. Good timing. >> I do need, John, to make certain that our chair has an opportunity. >> I'm going to take it that Allen Buchanan -- I have ceded my time to Allen Buchanan. Seriously, I would like to give my fellow commissioners a chance to ask questions. Jim, if you would. >> John, you're number one. >> Okay. Again, thank you. The bar was set very high this morning and it just keeps getting higher and higher as we progress through the day. As Amy Gutmann our chair has pointed out again and again, this is a deliberative body. Okay? And that entails that we need to ask questions like, who is going to be invited to the discussion and what sort of weight we will accord to what they say? These words of argument that they give. So both Greg and Allen have alluded, you know -- Greg at the start and Allen at the end, to how we should deal with questions of religious or metaphysical nature. And I just want to press this question a little bit harder because it does raise difficult and really important questions for any sort of deliberative body like our own. So, Greg, the way you put it originally was that you can respect the views of people who believe that this involves playing God and so forth, but we should sort of discount arguments that are based on sort of sectarian, religious views or on, as you put it, various world views. Now, I can easily understand how we should respond if somebody says, well, we should oppose synthetic biology because that's what Jesus would want us to do. Okay? Because that's clearly a kind of argument that not everybody can, you know, agree to. But if you widen the circle of suspect dialogue to include world views, that would include a lot. It may include Francis bacon's notion of teaming nature for human good, which most scientists would be guilty of. John Stewart Mill will have a similar view of science. And it would also I think include sort of deep ecologists who have a world view that views with suspicion sort of monkeying around in nature or, you know, adding synthetic genes to the natural world. So I'd like you to both really sort of circle back over this question a little bit and help us get a grip on exactly what's at stake here and exactly what your position is on this. Okay? In other words, are you saying that, you know, certain sorts of arguments should be ventilated, but not really given a whole lot of credit. Or what's the position? >> Well, I think that a full range of views should be ventilated. I don't think that the commission should be preventing people from coming to the table to express their views. But if the commission were to recommend to President Obama and President Obama were to decide -- I'm sorry. President Obama were to decide as a basis of deep ecological world view to oppose research into synthetic biology, that would strike me as potentially violating the suggestion that I made. But I don't think that there's going to be -- my thought is that there are certain kinds of -- everyone comes with a world view, but there are certain kinds of moral positions that can be set out in conversation without having to appeal to them. If I tell you that it's wrong to take the human life, you're not going to ask me what my background and my reasoning for that is. You're going to accept it at face value. But if I tell you that it's wrong to fiddle internally with the genome of a microbe, you might do that. And then I would be compelled to say something. And if it turned out that I was basing it on some unique claims about the status of life or some sort of vitalism, I'm not really -- I haven't really sorted out exactly where the lines are going to be. But that's going to be a problem for policy making. >> Just a quick reply. I think if you together come to a conclusion to make a certain recommendation, you should not water it down in deference to views that you think are false. Now, that doesn't mean that you should sort of go out of your way to try to show up people's views as irrational or somehow inappropriate. But I think you just have to be courageous enough to say, look, in the parts of our documents where we are drawing conclusions about this technology, we're going to call it as we see it. And we will have a full ventilating of a wide range of views. Nobody should be stifled. But that's not the same as saying that you should sort of view your conclusions as having to track the majority view of the public or that they should even reflect some substantial minority of the public's views if you think those views of the public are simply not supportable. Easy for me to say, but I think that's what you should do. >> So, Dr. Kaebnick, I wanted to press you about your view of the evolutionary claims and the highlight of the arguments developed now are based perhaps on a flawed view of evolutionary and nature claims. I wonder if there's a version of the claim that you might agree with. And that is that it seems like at least with the types of fixes that you refer to in evolution, some quick fixes that are brought together to solve immediate concerns, that the process is a slow one, right. So evolutionary fixes happen over time which allows the rest of the environment to adapt to those fixes potentially as well. In synthetic biology, we may be talking about faster changes. So you're both right in that we can develop much more efficient solutions, but potentially then the impact on the environment may be much greater, such that nature is able to achieve potentially a slower and more balanced approach than sudden, introduction of drastic changes goes. >> Well, I think there are actually some sudden and drastic changes that occur in nature without human intervention. I guess what I'd like to say is I think that the important thing is to recognize the complexity of evolved organisms and ecosystems. But recognizing that they are complex is quite different from saying that they are optimal and stable. That's the mistake. That's the mistake that people make. When they talk about a master engineer, they are attributing much more competence to evolution. Organisms are always in danger of intervene you prematurely because we don't know enough and don't understand the complexity. That's quite different from saying we shouldn't intervene because it's perfect and stable. A brief quote from Darwin here. What a book a devil's chaplain could write on the blundering low abhor I hadly cruel works of nature Darwin. >> I'm not saying that you would say organisms are perfect. But I'm wondering if the rate of change is different than the type of organism. >> It all depends upon whether the rapid changes we might be trying to make through synthetic biology or other means are ones that are likely to have a large impact on a fairly large ecosystem. And that's where all of these questions about containment and reversibility come in, right? And I think that's extremely important, you know. Those are the technologies you have to think about. Those are the risk reduction technologies that have to be thought about. You have to try to find out from the scientists which of the containment and reversibility techniques already developed in molecular biology and in the traditional genetic engineering are applicable to synthetic biology. Which ones aren't. Which ones have worked in the former case, which ones are problematic and which new ones you need. That seems to me to be the answer. I'm not denying this is a problem. You're right. If you make some profound change in organism that has fairly dense interconnections with a larger ecological sphere, then the recalibration of the rest of the elements of ecology of that may be pretty Rocky. That's true. Thought all the more reason to think about limited, contained kinds of interventions. >> Thank you. >> Anita, why don't we have your question? And then in the interest of time, go out to the audience. >> Thank you. I have two relative quick ones. For Greg, I was interested in the fact that you mentioned religion in connection with the intrinsic value arguments, and not in connection with the consequencialist arguments. Many people of faith coming out of religious traditionals are not just concerned with vague metaphysical respect for nature of the sacred or inappropriately playing God. They are also concerned about social justice and the kinds of issues we heard from the previous panel about the bioeconomy that the potential result from pursuing a synthetic biology. So I just want you to agree with me that -- [LAUGHTER] >> Done. >> Okay, great. Then for Allen, my question is a little more complicated. You made the point along the way that maybe we can manage some of the risk involved in synthetic biology by designing in safety, like the suicide gene or something of that nature. It occurs to me that is an often reassuring folk and engineer in safety. But hasn't experience taught us that we have to be a little bit careful there? Because, for example, with fast cars. Oh, we'll just engineer safety into fast cars. But then the corporate guys decide that it's too expensive to put that extra tough bumper on the back of a car so cars aren't as safe as they could be. Or in the data protection field, we all heard for the whole 1990s, we'll just engineer into the Internet privacy proposals. But then it turned out the website guys, they want to create a market of new information and not going to engineer privacy into the Internet. So we can do it, but whence comes the will to do it? And should the public feel safe that we're in fact going to get those safety devices engineered into the product? >> You're absolutely right, obviously, saying in principle, looks like there are greater resources for synthetic biology for designing in safety features. That's in principle. What happens in the real world? That depends on what the incentives are and the regive regime can test those limits. I think that's a crucial question. I wouldn't want somebody to overrely on the idea we can design the safety in. It's a combination of sort of external controls and some designing in. And the question is, how can you ensure that the designing in safety really gets done and gets periodically reevaluated and works in a complementary fashion with other kinds of safety measures that have to do with the environment that the product operates in? You mentioned the notion of justice, too. I just want to mention that the slide presentation is just a fragment of a larger piece that Russell Powell and I wrote for the commission that's about seven pages long. And in it, we do spend some considerable time on the justice issues. I'd like to say one thing about that. I don't think there's a peculiar part of justice in synthetic biologies, it's part of innovation. We live in a world in which innovation is very important. And our theorizing about justice and institutions have to take into account the problems with justice and innovation. For the most part, there really are problems about the slow diffusion of beneficial innovations. Okay? It's that we need to learn how to reduce the gap between when some people get a beneficial innovation and when the bulk of people get it. For some technologies, that gap is very small. Cell phone technology is the best example. Diffusion of cell phones has been quite incredible. Poor peasants in south Asia are revitalizing their economic life with cell phones. The political life of cell phones has been incredible, too. You can't assume a technology is going to diffuse quickly. We need to think about how to speed up the diffusion of beneficial technologies and don't be a synthetic biology exceptionalist and think this is just a problem for this area. The solution to the problem for synthetic biology has to be part of a larger problem of thinking about new practices and institutioning for justice in the diffusion of innovations. >> Why don't we take one question from the audience? If there is one. With the reminder to others that when we reconvene after this session, we will have a plenary that will involve all of our speakers so we can have more questions. Really just one at this time. I'm sorry. Hang on for the plenary session. Yes, sir. >> Good afternoon. My name is Sal hajarski and I'm a student. My question goes back to degrading life and you addressed this and I understood your counter arguments in regard to the subjectivity. But I have to be reminded of something that Mr. Thomas, the previous speaker who was up here, kind of brought up about the economics of the biology industry. What I was really wondering is what you think using life as a means of production would do in terms of devaluing life. I understand we use living things, obviously, as products. We have agriculture, etc. But we haven't really used it in itself as a means of production. I mean to the scale that we would be using biotechnology or synthetic biology, rather. So I was kind of wondering about that. >> Well, briefly, I'm just a little uncomfortable at talking about using life as a means of production. Life is just too big a term. Okay? If you get more specific, I think most of your concerns will dissipate. Okay? If you are using living things, you said it. We use living things as a means of production all the time. We are a living thing. We use ourselves. So I would worry about this kind of redefining talk of using life or people saying you can't patent life. That's not a very useful entry into the very complicated debate about intellectual properties to say let's don't patent life. Talk specifically about what you're talking about patenting and why you object to it. And talk about which biological processes you think shouldn't be used in which ways for which kinds of production. Be much more comfortable with that kind of talk. I just don't think it's very productive. You are clearly on to something. We don't want to treat everything as if it only had instrumental value. We can all agree on that. We need to get down to particulars, if we're going to get very far with that. >> Did you want to comment, Greg? >> No. I think that's exactly right. I think that the concern is a serious one, but I would want to search for distinctions along the way rather than treat all of life -- >> One of the things the commission has learned that in certain sessions, we need to allow a little bit more time. But what we will do is reconvene in just 10 minutes. This is quarter past 4:00. For the plenary session, we have all of our speakers with us and we can engage them in further conversation. Thank you, Dr. Buchanan, thank you, Dr. Kaebnick. [APPLAUSE]