Here are is the transcript from the second day. Includes some mention of DIYbio.
>> Thank you. Thank you, Amy. Good morning to everyone. Good morning to our commissioners, to our experts. Thank you all for being here. Excited to get this second day going. Hope it will be marked with the same frank and eager level of discussion that we enjoyed yesterday. This morning, as Amy has said, our first session is on ethics. We ended with a session on ethics yesterday and we'll start today's panel hearing from David Rejeski who directs the Woodrow Wilson center for science and technology innovation. Innovation program, excuse me. As well as synthetic biology project. And before he joined the Wilson center, Mr. Rejeski worked for the White House Office of Science and technology on a variety of technology-related issues. David, welcome this morning. We look forward to your comments.
>> Well, thank you. It's a pleasure to be here. I'd like to thank Dr. Gutmann and the whole commission and also thank your staff which I think have done a great job in terms of supporting everyone that was involved. I have some slides that I'm going to go through. Let me just start by saying that we have devoted about six years of our time into my project trying to essentially bring the voice or voices of the public into the conversation about science policy on emerging technologies. We started with nanotechnology and have now added synthetic biology. In terms of how we do this, it's pretty easy. We talk to them. We go out with a fairly intensive and structured discussions with people all around the country. We have run lots of focus groups in Spokane, Washington, Dallas, Texas, Cleveland, Ohio, Baltimore. Every year we do an annual survey with heart research. We'll be doing a new one in August on synthetic biology in which we'll be asking questions about what happens if next year we produce our flu vaccine with synthetic biology. It might be interesting to get public input on that question. We also do a lot of partnering with other groups that are doing similar kinds of research in the space. And some work on media. Let me yump in and give you a sense of what we found out. Big question, what is this? We have been grappling with this for two days. We ask people, how much have you ever heard about synthetic biology? These are the figures from 2008 and 2009. They have actually increased somewhat. At this point in time, 80% of the American public has heard little or nothing about synthetic biology. So who they hear from and what the message is and how they hear it could have a huge impact on future trajectories of the technology and our ability to use it. So you're in this I think very interesting space right now where people don't know much. Having said that, this is a complex word and it tends to, I think, elicit a lot of concerns as soon as people hear it. It's different than nanotechnology. People are, what is that? Synthetic biology, people think about this through analogy. And the train goes something like this. Synthetic biology is that like artificial life? Is that cloning? Is that stem cells? Is that GMOs? Within 15 seconds, you have hit every third reel issue that you might possibly hit. The term synthetic biology makes me think of genetic engineering and something lab grown. Cloning is the image I think of. I think about molecular compounds and playing God. This is the public speaking right now. So this is kind of how you're starting off. In order to kind of get around this, what we have tried to do is immediately focus people on applications. We go past the science right into application. Last year we did a lot of work on biofuels because that seems to be coming down the track very quickly. And the people's reactions to biofuels and the use of synthetic organisms and metabolic pathways is initially optimism. I think it's pretty good "But." The "Buts" are interesting. My concern is maybe we'll create something that we can't control. Here's another but. Once you start doing this, you open a Pandora's box and you might do things I don't approve of.
When you break it down, you find about a 30/30 split. People have concerns about the leakage into bioweapons, the moral issues about artificial life. There are a lot of concerns about these environmental issues. Could it move in horizontal gene transfer? The other thing we played with last year was it seemed inevitable almost that somebody was going to create some form of synthetic life. We weren't sure who would do it and when it would happen. So we played with that question. Here's what came out. Almost 100% of the people said more should be done to inform the public about this research. So you've got a fairly strong mandate. The federal government should regulate this research. 2/3 of the people said that. I'm worried about this. Over 1/2. I'm excited about it, less than 1/2. This tracks fairly well with what's going on in Europe. Here's a recent statement that came in "Nature" magazine. Without effective public engagement there will be no synthetic biology in Europe. Pretty strong statement I think. Artificial life needs regulation. So this will give you some idea. I think there's a huge, huge hunger for public dialogue on this issue. The dark horse in synthetic biology's future is trust, and whether we will trust the people that are essentially developing the technology, promoting the technology or doing oversight on the technology. So for the past three years, we have actually tracked trust in agencies. You can see where the government agencies are kind of oscillating in the 50% to 60% range. This is a broad question about whether they trust these agencies to maximize benefits and minimize risks, which is kind of what the commission is about. We added the DOE last year because of the biofuels work. The agencies beat the businesses. So this issue of who wins in a global race I think with synthetic biology, it will have a lot to do with how much social capital you have in your society. There's huge variations. There's much more trust, for instance, in government and corporations in China right now than there is in the U.S. So this trust issue is sort of lurking in the background, but it's something we'll look at again this year. We have asked people, well, how do we build trust? With nano tech, we'll be doing this in August. We found no public support for a moratorium on research. It always comes up, let's shut the system down. But we also found no public support really for self-regulation by industry. So this idea that industry is going to just look after itself and everything will be fine, there's just not a lot of public belief that's going to happen. When we asked people very specifically how can we build public confidence, the thing that happens is 80% of their responses converge around three answers. They want greater transparency and disclosure about science, they want free market testing. There's this feeling, this fear that we're taking technologies and pushing them into the market without doing the due diligence. The government isn't doing it, corporations aren't doing it. And they also like the idea of third-party testing. So they bring up issues and they bring up examples like consumer's union or underwriters lab or people above the fray or the National Academy of Sciences. Having industry do the testing is probably not going to work here. Okay. So then we sort of asked, where are people getting these ideas? Because they certainly aren't reading peer-reviewed literature, at least most people aren't. So here's the great filter. Some of you might know this Gary Larson cartoon. This is a scientist on the top and the media on the bottom. Now, if you think this is an exaggeration, this is what came out a few weeks ago. This was the institute of research and this is an analysis we did on the headlines in major press outlets in the U.S. The size of the words essentially represent the frequency of their use. A lot of people just skim the headlines anyway. So this is what they kind of got out of this. Craig creates synthetic life.
[LAUGHTER]
Now, if you think this is just an American phenomenon, we went back a few weeks ago and took a bigger sample.
We looked at the U.S., the U.K. and Germany. That was the U.S. It's about synthetic life, folks. This is the U.K. It's about synthetic life. This is Germany, artificial life and Craig Venter. So this is working constantly. I'll come book to this a little later in terms of whether this is problematic and how to fix it. The other thing that happens is there's very different ways of covering it we found in the U.S. and in the European union. This is work that my colleague has done. We basically looked at press for five years. This is the U.S. press. We seem to be very bullish on benefits. It's the same problem we had with nanotechnology and GMOs. A lot of the articles talk about the benefits. Very few talk about the risks. This is the European press, a little bit more balanced. The thing that's quite surprising is then you break the things down into issues. These are the issues that appeared in the American press. Synthetic biology has largely been framed here as a biosecurity issue. It's all about biosecurity. This is Europe. Biosecurity actually falls behind biosafety. There's a lot of discussion about the ethics and a lot of discussion about what we call business issues, the I.P. issues and who owns this. Much more balanced I think coverage. And one can imagine a divergence of public opinion and public policy between the two countries. Now, in the end, science has very little impact on public perceptions. Culture does. The late novelist David foster Wallace made the comment that human beings are narrative animals. That's how we understand science. So the sphere of public concern usually forms around threats, rather than benefits. This is one of my favorite set of comments in the 1950s, Captain marvel and the wonderful world of Mr. Atom. The narrative there was the U.S. Government really isn't paying attention to atomic energy and it falls into the hands of various evil-doers. These are deep, deep narratives. And they are powerful because science is essentially presented in the context of society and the people that do the oversight, the people who want to get at it for bad purposes, it's a story. We are story-tellers. When we have gone back and we have sort of thought about the focus groups, there's a bunch of narratives that are incredibly powerful that come up again and again. I'll give you three of them. Dr. Strangelove. This is dual use 1, corruption of scientists. This was in spiderman 2. If you've got teenagers, they probably watched agent Cody banks. If you have gamers, there's an Xbox 360 game called bioshock. Very powerful and built into every single media. The Trojan horse, very, very powerful again. We accept these technologies into society and we learn later that it's probably a mistake. DDT, CFC, Vioxx, this is a game called nano breaker, same thing. The last one is oops. The accidental release of harmful substances or technological error, there's a wonderful book "Prey," the release of nano Bots from a laboratory in the desert and "splice" where they have combined animal and human DNA. So the thing that scientists have to understand is people will fall back on these narratives long before they will ever pick up a biology book. And they are incredibly pervasive, ubiquitous and powerful. So let me close up with some communication challenges. What is it? What is synthetic biology? We actually have 11 or 12 definitions on our website so I think five or six is an underestimate. Let me make a comment. The scientists, industry or government have no communication strategy about this at all. We are mumbling in real-time. So it's wrong quite often to blame the media. The media that is problems. But the scientific community has difficult communicating what this is. Conversely, we haven't told them what it isn't. We had a discussion yesterday about whether this was cloning and we never reached a conclusion. So it's kind of open space for people's imaginations to operate in. And they will operate. The other thing, is this a big deal? Who knows? I mean if you look at the responses to Venter's research you go from freeman Dyson who thinks it's a turning point and another thinks Craig has overplayed this. Is this a big deal? Do we have any way of knowing? How do we communicate? How does this impact individuals and society? I think we went through that a lot yesterday. Jim Thomas awakened us a little bit to the larger impacts we have to think about. Let me just tell you that people always impress me. In the social context in which the public thinks is much broader than the social context in which most scientists think. They are going to ask very hard questions about who is developing this, who is promoting this, who wins, who loses and what can go wrong. Those are nagging questions for which we have quite often no answers. I'm always impressed about how intelligent people are about this. What can go wrong? They constantly ask us what can go wrong. And if something goes wrong, who's in charge. Where is the 800 number? Who do I call? Is it the White House, the F.D.A., the E.P.A.? The other question because of what's going on in the Gulf of Mexico is, can we fix it? Can you plug the hole, daddy? As Obama's daughter has been asking. Is there a biological blowout preventer? We heard a lot of stuff about suicide genes and phenotypical handicapping. Can you do this and guarantee it? And the public will ask questions like that. I think we need to be prepared with answers. So just some final thoughts. I think it makes sense potentially to launch a bigger national dialogue on synthetic biology. This is the one that the U.K. just did, which ran for eight or nine months. Might be able to build off of the lessons they learned. I think there's a need to actually set up a very visible coordinating office and body in the U.S. Government. With nanotechnology, we had something called the national nanotech coordinating office which did a lot of outreach and inreach. And so there's a place to go to. It's not clear kind of where you go here. This is going to happen soon. I predict in one year, someone in the Congress will ask the General Accountability Office to examine the adequacy of our regulatory system to address synthetic biology. And they should. The GAO would provide an independent assessment. They have the capacity to do that. They have moved into technology assessment. And I think we need to do this sooner rather than later. This was preempted because somebody actually suggested this the National Academy of Science undertake a new study of the environmental impacts. The last time the academy looked at bio containment was 2004. The chapter on synthetic organisms is relatively weak because they were very focused on animals, transgenic animals and plants. So it's time to take a hard look at this. I also think people have to look at potential for extremely low probability but high-impact events. At the beginning of the nuclear age Hermann Kahn at the Rand social said we need to look at people called black swans, people that could be game changers that we're not thinking about. And finally, I think it's time to really engage in greater international collaboration, not just around biosecurity. I think a lot of that is happening. But issues like risk research, international property issues and this one kind of coming up again and again as we talk is the biosafety issues. So that's my comments. All of the things that I have referred to are up on our website. The work we do is funded by the Sloan Foundation.
>> David, thank you very, very much. Let's move right along. We'll get to Q and A later. Our next speaker is Markus Schmidt. Dr. Schmidt is the cofounder and board member and project leader at the Organisation for dialogue and conflict management in Vienna Austria. We certainly welcome you and look forward to hearing from you.
>> Thank you. First of all, I would like to thank the commission for inviting me. It's an honor to be here. I think it shows the commitment of the commission to have this discussion and on synthetic biology on the international level. I will not try to hide my lovely Austrian accent during the presentation. You have asked me to give an introduction in Europe. I have 15 minutes for that and I will try my best. As an overview, I will try to give you an idea of what we think falls under the umbrella term of synthetic biology, rather than to give a definition to just see what's going on and who is doing what. And it's a little bit about the role of Europe, compared to U.S. and the funding, what the European ethics councils are doing and what recommendations they are giving and some examples of projects in Europe. We have heard something about maybe a different definition than what this included in synthetic biology. Cloning, stem cells. So it took me quite a long time. I'm working in synthetic biology for five years now. And it took me a little bit in order to grasp that. I think we can make out five different sub fields or under the umbrella of synthetic biology. The first one is DNA synthesis or genomes. The reason this has been put in place by Barack Obama and what Craig Venter is doing. I think you can maybe call that synthetic genomes. And maybe the step ahead, you can say that if synthetic genomics can create life, it's pertinent to ask if gutenberg has created the Bible. He was not a Shakespeare. This was attempts by the second group category which is DNA-based biocircuits and the creation of a system made of parts of genes. And we have heard we still have limitations in doing so, but it is going on. The third group is working on the minimal genome to reduce the genome in a living cell to the extent it can barely survive to know about the least complex living systems, and to be used as a chassis for the second type. The first three types are actually you can say this is life as we know it. Right? So they are using more or less similar principles of natural organisms. The second and next two parts are actually descriptions and attempts to make life as we don't know it. Protocells are trying to make cells from scratch and putting together in a way one point in the future this will have all the characteristics of life. I think this would be the category you can say they are trying to make real synthetic life, synthetic cells. The last part is chemical synthetic biology. There are attempts to diversify the biochemicals of life and to have six or eight or 12 bases instead of four and to replace chemicals and these things would be octagonal or different from other organisms and have a genetic enclave for biology firewall as a safety system. All right. Comparing Europe to the U.S., there are many ways to do that. I went to the department website and found it as well. The U.S. is ahead in terms of publications and also in terms of receiving funding for the work, but Europe is second to the United States. So I think together we might have 80% or 90% of the synthetic biology volume, capacity in the world. But Europe is very diverse. There is on the one hand European commission funding and initiatives but there are different. In some communities there is the research community but lack of funding. In Austria we have the community but very few scientists working on that the. The benchmark is in Europe. And they are required to work together and to collaborate. So they set a good example for Europe. All these publications, work and funding in Europe on synthetic biology have drawn to the attention the fact that there might be biological issues and a couple of bioethics working in this or not working. In the U.K., the Council on Bioethics has repeatedly decided not to work on it in 2006, 2007 and 2008, but other countries have. In Germany, there were different ethics council and the council in the German parliament and the German ethics
council.at first the term said it was not relevant and they Dant want to work in that but the ethics and German parliament said it might be relevant. And now I think the German ethics council is doing something in it as well. Switzerland, actually a very interesting publication coming out. The federal ethics committee on non-human biotechnology, a long word in German, they look especially on the nonphysical harm part of the synthetic biology. So the dignity of microbes. Looking at microbes and if we can treat microbes as a machine and if they have positions like egocentric and they came to the conclusion that the majority of people in this have a biocentric view and say microbes are not a machine. This dignity is less and not as important as other higher animals and organisms and we can use them in any way we want. It's a green light for scientists. Also in the Netherlands, there was the cochairman made a statement, but I would like to say a little bit about the European commission itself. In 2008, the President asked his European guEp on science and new technologies to also have an organized recommendations or to come up with an opinion paper which stated and published in November last year. We are interested and they asked what is our one recommendation to you, it could be you want to look at their recommendations and see if there is something you can use. As I mentioned before, biosafety is really an important topic in Europe. Much more than biosecurity. I think we are one major difference between the U.S. and Europe. There are several points in biosafety, especially we need to be aware of risk assessment methods so that we can in the future try to assess the risks of new synthetic biology tools and methods, otherwise it would run into a situation with just uncertainties. They also ascertain there are products that come out of synthetic biology and it's an idea that they could do. Include the biosafety standard when doing import-export with synthetic biology products. And promote public support for basic research and ELSI work. Here is a timeline of different projects dealing with societal aspects in Europe. The color doesn't have any meaning. It's just more colorful. Some are stand-alone and others are parts. So in order to map the different projects in this world, you know that Europe has a history of colonizing and we do that and have this virtual world here. Five different areas of synthetic biology and different ELSI aspects, okay. Also try to map the different projects into this world. You see that most of the activities are going on in biosafety and ethics and most of them regarding DNA biocircuits and those are initiatives and and there are some activities on science and society. And socioeconomics. My last couple of slides, I'd like to present some of these projects I know best and have been part of. The first one is synbio save. It was in the way of a pilot study to map fields and see if there's anything new in safety and ethics. And we did this in our ethical part and found out that the ethical aspects that may come up in the project can be attributed to three different areas, whether it's about applications like human enhancement. For example, we can do synthetic human chromosomes that can be useddor gene therapy that would be an issue or related to its distribution. It's the bioeconomy and what is the effect of synthetic biology on the global justice and the distribution and benefit in order the procedure is the international status of living machines. Regarding biosafety, we have three questions or challenges. The first one is we need to find new methods in risk assessments in order that we can have some certainty about the risks of new products in biotechnology. And second is what are the ways to improve synthetic biology, to improve the biosafety by using tools of synthetic biology, for example, I mentioned before the different DNA with different chemicals. We would have different forms and feed nature and so forth. The third one is what happens if nonprofessionals, amateurs and people start using that. In addition to some publications, we also thought it was necessary to produce some material for the general public so that more and more people are interested and motivated to enter the discussion. We did this documentary film. I brought a few copies for the commission here. You can get more information on this website. Starting from this more general assessment of risk and benefits, another project here, TARPOL which is the targeting environmental pollution with microbial systems a la carte from the framer program, we're looking into specific applications where synthetic biology could make contribution and try to find out what its economic and environmental and social impact would be. Okay? So this is going to be accomplished in September. So this is a draft. If you want, I can send you the final version so we have, for example, in biofuels and looking to ethanol, non-ethanol kind of fuels, algae based fuels, biohydrogen and try to evaluate the different aspects. This is a way to go away from the general assessment to a more case by case assessment. Another project that we have done in Austria is where we wanted to know more about public perception. This is in the light of a certain lack of knowledge about synthetic biology, although we have in the last couple of years more and more press articles, in this case the German language but very similar in other cases in Europe. But there are certainly most of the people haven't heard about this German in the United States. And it can give you another hint in September, the Europe study is going to be released. And this is every three years the European commission is doing a massive poll, opinion poll in Europe asking a total of 30,000 people in Europe on different aspects of biotechnology. And for the first time, we were able to slip in some questions on synthetic biology. And it's going to be -- I have seen the results but I can't tell you yet because it's published in September. It's going to be useful for you. Doing this and this lack of knowledge and awareness, we're doing a real-time experiment, asking scientists to write press releases, asking journalists to write articles and give that to eight focus groups consisting of different parts of the public. And what we found was that -- these are the eight groups, right? And the scale is if the people would be the positive link line or negative or neutral. In the beginning because they didn't know anything, they are more or less neutral and don't have any opinion on synthetic biology. Actually, the name should be here as well. And it turns out that after they received the articles, we see that like the majority, like half of the groups that didn't change their opinion, they still didn't feel -- seem to engulf them a lot, but two groups had the suddenly negative opinion and two groups suddenly get a quite positive opinion on this. So this group on the left was an environmental and this group was a Christian NGO and here we have students and these are members from the economic chapters. It turns out synthetic biology has the potential to polarize parts of the public while we have a silent mass of people that don't care a lot. But, of course, there are people on the fringe of interesting. We also found that in this communication process from science to media to the public, actually the very essence of synthetic biology got lost. So while they beginning the sign tichts were talking about why it was different from genetic engineering and they had the standardization and the engineering principles, this got lost. And in favor of a more application focused kind of information that was conveyed. And this is important from the point of view of journalists because they want to write something that is relevant for people and it's about applications. So because they just talk about applications and about the method behind it, people cannot make a difference between synthetic biology, genetic engineering or bioculture, so they put it together. And the research from this communication process, the nuances get totally lost. This is my last slide. We heard yesterday if synthetic biology is successful, imagination will be the limit. If this is really the case, I think we should invite people that are experts in imagination and maybe not only engineers. And so we are inviting filmmakers and artists to give us their version of what synthetic biology could change our society in the future and we are going to do the science and art and film festival at the museum of natural history in Vienna and we're still inviting people to send us short films. I think it's going to be a very interesting festival. With that, I'd like to thank the commission for your time.
>> Thank you, Dr. Schmidt. Very interesting to see the sort of European response to the challenge and challenge for public dialogue that David Rejeski issued to us. Our final speaker in this morning's Pam, I have a special pleasure to introduce, Dr. Paul wonpy, the aa Griggs Candler professor for bioethics at Emory. He sits on the editorial board of a dozen professional journals, the past President of the American Society for bioethics and humanities. His work focuses primarily on the social, religious and ideological impact on the human condition. I am delighted to welcome you here, Paul. We look forward to what you have to say.
>> Thanks very much. It's a great pleasure for me to be here. I'm a sociologist and social scientist and very atypical for me, I will not be using slides. You know how some people can't talk without their hands, we'll see if I can't talk without a PowerPoint presentation. I was pleased with the breadth of ethical concerns expressed yesterday because it freed me up to talk about what I think are some often less considered and underlying and deeper ethical concerns that I have. Concerns that are troubling in some ways as ecological or pathogenic concerns but much more difficult to know how to address. My assignment today, what I was asked to do was talk about religious perspectives on synbio. And I spent a few weeks reading the literature. I spoke to people from a variety of faith traditions, from Buddhism with Emory's wonderful Emory Tibet program that we have, people from Islam, Christianity and Judaism, Hinduism. And what I discovered was there was remarkable agreement about synbio. And that is at this point, they are unconcerned. Fundamentally, their objections or their concerns were those of all of us in this room. What are the potential harms? What might happen if these things are released into the environment? And they expressed a concern that synbio keep its eye on maximizing human good and reducing sferg. And if it does that, it's acceptable. And that was reflected, I think, in the Vatican's response, for example, to synbio where they said that the recent creation of Venter's cell can be a positive development if correctly used. And then there was a warning afterwards, but scientists should be careful about playing God, creating life, remembering that only God can do that. I found the questions that we typically ask of religious traditions about bioethical issues to be relatively uninteresting. We focus on asking for them to sanction what science is doing but I don't really think that's the right question we should be asking of religious traditions. It's not where they can make their greatest contributions in telling us what we should or should not do. Rather, I think that modern science is simply the newest means of trying to struggle with eternal questions about how to minimize human suffering, what our proper relationship is to the natural world, what are the important problems we as a species must solve and so on. Religious traditions have had centuries to think about these questions. And the smartest people of their age throughout most of human history drifted into religious dialogue. And so those traditions hold wisdom that we can draw from. We know that the role of science is generating knowledge. What I think the most valuable role of religious troishes, what I think we should ask of them is how to generate wisdom, which is a different quality than knowledge alone. And so for a few minutes, I want to talk about what kind of wisdom might we glean about synbio and similar biotechnologies. These aren't going to be the points that are usually made explicitly by religious traditions or religious spokesmen, nor do they come from particular religious traditions. They come from a generalized religious sensibility, a positive that asks what might be positions be if we start from the premise, there's something sacred about our lives even if you define the word sacred in its most secular sense. Religious sensibility that I mean is shared by a variety of people by faith and people of no particular religious faith, by both the theis and agnostic and atheist. Begins with the premise that life is rare and precious, our biosphere is fragile and sing lar. And we have evolved to be the stewards of the planet and very powerful stewards at that. One last point before I move on to the specific points I want to make, I don't think wisdom is at all an exclusive domain of religion. We find it in art. We find it in literature and we find it in science as well. In fact, if you look at science's impact on religion over the last 100 years or more, we see as profound an impact going in that direction as we do in religion's influence on science. I'm interested in that dialogue between science and religion to some degree and how they can mutually inform each other. And that is a dialogue of longer duration and greater productivity than is generally appreciated. I want to give four examples of ethical issues that are difficult and perhaps retractible and might reflect this generalized sense that I've referring to. First is the idea that human beings are cocreated by technology. We think of ourselves as the creators of technology, which we then somehow send into the world and then we create the next technology and send it into the world. We pay far less attention to the way that the technologies we create then reciprocally recreate us, recreate human beings and recreate human society. The invention of the plow shaped human societies, modern civilization itself was largely a product of plow-based agriculture. The automobile made suburban life possible, moved industry out of the cities. And even perhaps ended the era when people had to keep animals for transportation and thus estranged us from the natural world even more. Computers, we don't have to mention how they have fundamentally changed us not just the socioeconomic and the computer power and even parents being unable these days to figure out how to communicate with their own children. We have a whole different system of communication than many parents do. Yesterday we heard some speculations of how synbio might contribute to bioeconomic dislocation. Powerful technologies can change social relationships. Change how we think about problems. New technologies create new problems that call for even newer technologies to solve them and create their own challenges which we address with even newer technologies which is why we always seem to have both too much technology and not enough technology at the same time. So how will synbio change us? I have no idea. I don't think anybody does. Perhaps it will accelerate the biomedicalization of life where by diverse human phenomena are recast and redefined primarily by their biomedical nature. Perhaps it will change our personal self-conception from one that thought of individuality as a variation on our commonality to one emphasizing our polymorphic diverges and idiosyncrasies. Perhaps it will be all biological forms will be taught of primarily in terms of their utility. I don't know. It's too early to tell and premature probably for the commission to speculate on. But I think we all agree that looking at technology in isolation from the economic, social, philosophical implications of future development is to fail to fulfill the deepest meaning of the President's charge to explore the implications of the field. The second issue is speed. And this is a point that I think is often overlooked in talking about technological change. Speed itself is an ethical issue. We live in a society that explicitly and implicitly presents speed as an ethical value, taking longer time to achieve similar results is see as less desirable, as wasting time, doing something faster is doing it better. Synthetic biology and genetic engineering as well justify the utility in part as we heard yesterday on how they have dramatically collapsed the time horizon of evolutionary change. Yet speed is a problematic value. Selective breeding, for example, is limited, difficult and time consuming. And so in that sense, genetic technologies are an improvement. Because it plays out over long periods of time, it allows for reflection and self-correction. Change happens slowly which offers a large range of choices at new increment of intervention. Synbio makes that in one step. It may take many generations to understand the single gene change on the integrity of an organism as a whole. It may take many generations to understand the impact of alterations on the environment. Even transgenic have changes that differ from selective breeding. Speed has an impact in two senses. One in the ways that synbio speeds up natural processes and second in the explosive development, and dissemination of synthetic biology, technologies and methodologies themselves. How do we think about, accommodate and understand the ethical implications of speed? The third is incrementalism. It's a difficult dilemma. We can follow a path where every step is examined individually and found to be ethically unobjectionable and yet 100 steps later we found ourself in a place that no one wants to be. The idea is also captured by the fact that most synbio research findings advance our knowledge incrementally and yet somehow we see the enterprise as a whole as transformative. One of the reasons for behavior-based religious systems like Judaism or sharia in Islam or for the vennia of Buddhism is to guard against incrementalism and what is seen in these religious traditions as keen of pernicious potential to drift slowly away from what each tradition sees as right paths. I think in fact it is actually a kind of incrementalism that people are trying to combat when they resist biotechnical change or resist an enterprise like synbio or nanotechnology. Perhaps it's even what underlying the playing God objection to some degree, so when we respond that we have been playing God since homo hablus produced tools, yes, we have been playing God along the way, is there some way in which changes to our natural environment, our changes to our physiological integrity, our changes to fellow creatures has crossed some line, though the line is obscured by the fact that this step really isn't that much advanced from the step before us. It presents a real policy challenge. How do I say that step "A" is okay and "B" is okay and "C" is okay, but "D" isn't okay when "D" is really indistinguishable in many ways from "C" and the real reason I want to stop at "D" is because I see "H" down the line? How do you create a policy that captures the subtlety of incrementalism. It's very difficult and perhaps the best way is to address in a positive way creating goals and incentives rather than trying to stop things. And the fourth point is what I call the fedishization of progress. And this is something that is often expressed by religious traditions. A fedish is defined as any object, idea, etc. illicitting unquestioning reverence, respect or devotion. Got that right out of the dictionary. I submit that description countizes the general cultural posture of many people and most scientists toward scientific progress. Here religions have a lot to say. A report of the executive committee of the European ecumenical commission for church and society wrote our Christian heritage teaches us to be skeptical of romantic notions in scientific progress that prevail in some parts of the scientific and political communities, our support for scientific research is moderated by our awareness of human finiteness and fallibility. Modern biotechnological science has a history of failed prediction and I verbally from predictions of gene therapy that I was very involved in early in my career to the claims early on that nanotechnology is going to solve hunger and our energy problems and virtually everything else. While the cautions of some temperists are easy to dismiss, there's wisdom in pausing periodically to question scientific utopianism, the argument of urgency and other arguments of some biotechnical advocacy. Programs here it might be instructive to conclude, as both the previous speakers alluded to drawing from two narrative traditions or two narrative tales, one from secular Christian tradition and the other from my own Jewish tradition. There are two tales in addition to Dr. Strangelove and oops and the other thing that they were saying which are in this area. The first is the tale of Frankenstein. The tale is a product of a Christian cultural view that had underpinnings of suspicion about technology. By the way, what isn't usually commented on is this idea of playing God is a Christian idea. It doesn't exist in Judaism, Hinduism, Islam or Buddhism. All of which are much, much more historically predisposed to science than certain strains of Christianity. That's not true, of course, of all strains of Christianity. The story of Frankenstein is a scientific one. Anyone can manipulate life and create it. Some may remember Mel Brooks "Young Franen Stein" where gene wilder broke in and figured he could do it too. Dr. Frankenstein transgresses and European thought condemns him. It is a monster, a freak. The story of goalem is quite different. He's created to safeguard his people. The talmud accepts it. There's stories of creating goats and they consider the goalum part of the co-creation with God. Unlike Frankenstein created by putting together biological parts. The goalum is a synbio creation. He writes three letters of a religious genetic code on his forehead and then he's alive. There are two differences in the last second between these stories I want to leave us with. Victor Frankenstein is portrayed by Shelly as a driven man, arrogant to displays personal cowardice. His temper is violent, passions strong. When the monster disappears, he is relieved and flees rather than taking responsibility. In contrast, only the most righteous can create a goalum and manipulate life. And the agree of success is correlated with their degree of righteousness, by breathing life into the clay, rabbi Lowe emulates God and sees his responsibility to emulate other qualities. And in the pact, you will see one of the biggest concerns were the most vaition and disposition of scientists making the research, whether they could afford dignity and respect in the natural world. And finally, the second and last point I want to make about these two stories is Dr. Frankenstein loses control of his namesake. There is no safety mechanism built into the monster. And ultimately Frankenstein must pursue his creation and he dies trying unsuccessfully to end the monster's life while the goalum always remains under control of its creator, rabbi Lowe builds a safety valve into the goalum. When he gets out of control, he has to move one letter off the forehead and it turns back into clay. And it is hard to see the leaders of synbio have taken the safety valve seriously and built it into the products. To the commission, I have tried to highlight three or four what I think are very difficult issues. And I think the challenge to the commission seems to me is to take the extraordinary knowledge presented us by synbio and temper it with wisdom. Thank you.
>> Thank you. Appreciate it. I do want to defer first to the chair but we have questions from the commission.
>> I'll wait for my question and go straight to the commission and ask mine later.
>> I don't know. Thank you all very much. Paul, I want to reassure you that it's perfectly okay not to use PowerPoint. I believe that PowerPoint is the spawn of Satan.
[LAUGHTER]
I actually applaud you for not using it.
>> The commission will not take a position on the use of PowerPoint.
[LAUGHTER]
>> But I'll be working on you all. So I want to begin with this reflection on the absence of trust with regard to these sorts of scientific developments. I think that Dr. Rejeski is correct that this is the social environment in which we are working here. It's an environment marked by an absence of trust. And we see this all around us with regard to BP, with regard to climate gate and so on where there's just a high degree of suspicion with regard to all of our major institutions. The church, science, business, government, everything. So in this kind of environment, I think you're right that some kind of public outreach, public engagement will be absolutely crucial. And I have read your excellent article, David, in the reader which does talk about the importance of engagement with the public. But I think we need to probe that a little bit deeper to get at the rationale for doing so. I mean one rationale could simply be to sort of work on the public, you know, to sort of massage the public or tweak the public in various ways in order to make the world safe for scientific development. Another way of thinking about it, which I think is much more plausible and philosophically appropriate is to view public engagement as a way to obtain public legitimacy. In other words, if the public sees itself as having a role in the formulation of public policy, that bestows a certain amount of legitimacy on the project. I think we can see this. We have and tick dotes so far. We have a couple of case studies in this. One of my favorites is the rationing program in the state of Oregon, where public officials in Oregon basically reached out to the public, engaged them in a prolonged discussion. And it turns out in the state of Oregon, people can -- the state can ration healthcare in a rational transparent and effective way that gained public acceptance. I wonder what you think about this process of public engagement in the area of synthetic biology. Is there any evidence that this kind of engagement will indeed engender and increase legitimacy? Or is it a theoretical notion that, you know, involves a lot of hand waving?
>> I think there's always a certain amount of askepticism and fear of doing this. I think the scientific community is often used as a deficiency model which the public simply doesn't get it. If they only got the science, they'd get on board. And part of the problem is, of course, this public is asking a different set of questions. I think one of the problems that you run into immediately, if you wait too long, it appears disingenuous. This happened to a large public engagement process in the U.K. called GMO Nation where it really started after -- essentially, it looked to the public like the train had left the station.
>> It is their worst fear.
>> Recently the French conducted a large engagement process on nanotech and it was shut down by protests, again because people felt nanotech products are on the market and we have essentially done this before. So I think part of it, there is a timing issue. I think if you really are serious about this, it has to be done fairly soon. The report we just put out on participatory assessment says there are ways of doing this that are extremely well tested. We have done 16 of these types of exercises in the U.S. alone. And they are used pretty widely in Europe. This is just a matter of getting a representative sample. One of the things you'll grapple with and I'm sure you'll be asked, are the people you're talking to representative? That's a statistical question and methodical question you'll have to deal with. There was an interesting process that was run on biomonitoring in Boston. This was done a few years ago and brought in a wide range of people from the public, fairly representative sample to talk about monitoring. And it was visited at the same time by the head of the national academy panel that was doing essentially an investigation on biomonitoring for the U.S. Government. His response was he was stunned at sort of the level of conversation by an informed public because you actually have to inform the people what's going on. And the fact that they actually came up with new ideas. I think it goes beyond legitimacy. I think people can generate new ideas, new ideas for policy, things you hadn't thought about. So I think it's not just sort of educating and dumping knowledge, it's not just trying to get some legitimacy by having a dialogue. It's also the fact people are smart. They get this stuff. And that's why when we have done our public focus groups, we float a lot of public policy ideas. People come back and say what do you think about labeling? What do you think about a moratorium? What should the F.D.A. do? What can they do to build your trust? For me, I come from a policy world. So I think the use of these as ways of informing public policy is actually very, very critical. So I would push you to actually go beyond the legitimacy issue and just having the dialogue and say how can I learn something from millions of people, at least a representative sample of those.
>> I have two questions. I want to thank Mr. Rejeski for your enlightment. And your questions are critical as well. My questions are directed to Dr. Wolpe. I was quite surprised when you said there was no religious perspective or difference at least within the religious community. And I wonder if that was a representative population that you spoke to. I would suspect there may be some differences particularly around the questions of life, dualistic versus materialistic concerns about the creation of life. And so I wonder if the question of awareness and the degree to which synthetic biology is being included under the large umbrella and whether or not you think there may be concerns develop. Let me ask you the second question next. Your answer to incrementalism and to the rate of change is we should create goals and incentives to keep in mind as a way to direct this. And I wonder if you have specific ideas of what the goals and incentives are and if they would address the shifting rate of change in the environment.
>> Thank you. I wasn't trying to say there wasn't religious objections to synthetic biology. There are some religious groups that object to virtually the entire modern scientific enterprise. I spoke to mostly official or high-place spokesmen for religion and these religious traditions asking them what their religious traditions say specifically about this particular case of the creation of the artificial cell. What I got in response from almost all of them was at this point the actual act of creating a synthetic genome and inserting into a cell that replicates is not one that we have any particular ideological or theological objection to. I asked a very narrow question.
>> It was not about synthetic biology generally or views about this.
>> Right. In so far as the conversation, it went on to where their problems lie, they tended to all be down the rolled or they tended -- down the road or in this intrinsic issue of Huberis or human intervention or humidity and -- humility and issues like that. Part of that is synthetic biology is an enterprise and like us we don't know the implications. And there's a let's wait-and-see attitude. But religious traditions outside Christian religious traditions tend to see the use of other forms of life to better human life as a legitimate enterprise within certain limits.
So creation of synthetic biology products that would cure disease or help with things like mitigating pollution are seen as legitimate scientific goals. The issue of incrementalism, the reason that I'm suggesting positive incentives rather than regulatory limits is because nobody knows and I certainly don't know where to put regulatory limits. As I say, it always seems arbitrary. Therefore, in some sense, it is very practical difficulty that leads me to suggest that positive incentives are a better policy strategy. At this point, I think it's premature to suggest where the proper goals of synthetic biology are. That needs a little more time. But it is exactly what we do in medicine, of course. So we create the NIH. And the NIH is the steward of public funds. It looks at all the possible places that it could invest public funds. And it makes value decisions about what kinds of medical products, goals, cures, preventions are in the best public interest and incentivizes the system to move in those directions. That's what NSF and what our public funding agencies and private funding agencies do. I was suggesting, it's such an intractable problem, the problem of incrementalism, that is a better strategy, even though I don't have a specific recommendation at this point about what specific goals that incentive program should pursue.
>> I'd like to ask Dr. Rejeski to perhaps be a little more granular in your thoughts about how you would organize the lack of a communication plan certainly in this country compared to Dr. Schmidt's presentation which is fairly I think stark support for that comment. How would you suggest, based on your comments of yesterday, you wanted more government agencies to be in the room and to be part of this process? And yet when you went through your five specific recommendations, you suggested a coordinating body or office within the U.S. Government. Where in your view should that bully pulpit be? And what would you recommend for its composition outside of U.S. Government agencies? How would you interdigitate with the international approach that you did mention at the very end? But Dr. Schmidt showed with great granularity. How would you bring in a community advisory process so that this would not be a deliberative process that would seem to be in the hands of just policy or wonky people?
>> Well, the last thing is obviously the big danger. I think logically, it should be at a White House level. You know, it could be worked down at the national science and technology council. The national nanotech coordinating office was set up as an independent body that reported up through the White House and was funded essentially by the different agencies. I think that is one model. I think they were consistently underfunded so you have to figure out a way of kind of levying a certain tax on the agencies to make sure there was enough money there. So one of the tasks that office was given was to actually have a national dialogue on nanotechnology. And that never really happened. There really wasn't enough money, enough umph there. If you did it, you have to come up with some way of making sure that there's enough funding go into the coordinating function. The agencies have to be able to pony up some money to make that happen. In terms of advisory bodies, you know you're going to run into FACA issues in terms of the federal advisory act. But it may be worth going through the process to actually set up a FACA that would bring in the wide swath of population and communities to be able to sort of get ideas off of. The other option, there's nothing that would stop government and the agencies from going on the road. When I was in the White House, we did work on the national environmental technology strategy and we had 25 meetings around the country. They were just the kind of thing you're doing but again focused on a specific technology and science area. We ended up also with a White House conference which is another thing that attracted 1400 people. So we were constantly bouncing ideas off, ideas that had been taken from the government and getting lots of different feedback. I would say that one of the things that came out of that was exponential improvement in our strategies because we were able to really interact with stakeholders. I think there's a bunch of different ways. The level matters. It has to have White House support. That's where it belongs. If you have a coordinating body, you have to have essentially enough money behind it to make it work. There has to be some leadership there. I would certainly recommend the use of potentially putting FACA in place. It might help.
>> Thanks again. I think we were treated to three very different, but very, very good presentations. My question would be for Dr. Wolpe. Paul, you probably know there are sort of two ways we can think about religious voices participating in public dialogues like the one this commission is conducting. One strategy is to sort of only give publicly accessible reasons. And the second is to allow people of religious communities to speak out of the fullness of their traditions. You seem to have allowed a broader sense of the second kind of participation in a dialogue like this. I was wondering what you think the actual -- if that's true, what the actual value is of allowing people to speak out of the thickness of their own traditions as part of a public debate about a contentious issue like this.
>> Religious traditions don't get to talk about why they really believe what they believe. If you get up in front of Congress or a commission and you say I think this is wrong because the Koran tells me it's wrong or the Torah or whatever your sacred scriptures are, it's the end of the conversation, not the beginning of the conversation. You have to translate parochial religious ideas into universal principles if you want to be convincing about why you should take actions. But I think underlying the parochial reasons that religious traditions think things are often very deep principles that can be universally expressed. And I think that in our society, that is the greatest contribution of religious traditions because these are well thought out, centuries old, much debated, much very nuanced positions. So that's what I tried to do here, rather than reiterating what I think are very easily accessible and commonly discussed religious positions about technological issues. I was trying to get underneath the surface and ask what is the font of concern from which religious objections spring?
>> Well, thank you all three. This has been enormously insightful and informative. I think it will help us moving forward. I really like the idea, if you would mind my changing one word. Instead of knowledge, tempered by wisdom, knowledge coupled with wisdom. And I think we, as a commission, would like to issue a report that is informed by the facts, knowledge, and driven by values, wisdom. To elevate it a bit. And I'd like to ask any of you to share -- we can start, if you want, with Paul. What are the values that you see us having to deal with? What are the values that are most relevant to the issue of where synthetic biology is likely to go? The values that we need to deal with as a Presidential Commission. Just I know this is a big question. But if you can give us one answer.
>> My answer would be that it isn't a single values question. It is a balancing of values problem. That is, when I talked about the fedishization of scientific progress, I wasn't trying to say I was against scientific progress. I am extraordinarily for it. I live my life in a medical environment and celebrate medical advances but there are other values that have to be brought in. I think your challenge is not so much what is the value we should represent in our support that will be the value that synthetic biology needs, but rather how do we create a report -- and I think temperance might be the right word -- that takes all of these competing values and balances them in a way that makes policy valuable.
>> I should say that why I asked about values, there was a famous philosopher who said that values without facts are lame. Facts without values are blind. So we take both sides of this. You can speak to either one.
>> I would like to refer to this Swiss bioethics commission with the positions one would have and from that different values are entertained. There were, for example, thinking about people that believe in the kind of -- that every organism can be explained or reduced and the properties can be lost. And there are a lot of people that have the point of view that doesn't know there's something special in life. There is some X-factor that cannot be controlled. I think many in synthetic biology, they come from this monism concept and there's a misunderstanding of this idea to think the two positions can get in the way, in a way that it's a direct attack, so to say, that there's some specialness of life. And this carries a lot of value. It is the position as unfounded as the other one, but it's a way we view life. And if we attack that, or if this is an attack by synthetic biology, it could trigger some strong reactions to that.
>> I would think that one of the things that would be very useful in the report was a sense of the sensitivity and celebration of plurality. We are a very plural hetero genus society. One of the things that's so striking when we do focus groups is the huge difference. We talked about religion. There are huge differences between men and women. There are huge differences between whites and people of color and how they view this and the trust issues. And I think it would be phenomenal if the report could kind of reflect that. We have a plural society and we have gone out and we have kind of looked at that. And we have gone deeply into the little pockets of society. And I think that's something that is what gave rise to quite often resistance in the environmental justice movement. I think that's something you have to do. There's going to be the sense of how deep have we gone. How sensitive have we been to the plurality of the society? I think it can be dealt with on the basis that links values with facts.
>> Thank you. And thanks to the panel. I might ask David Rejeski a question, but also open it to the other panelists. There are certainly unique capabilities of synthetic biology. But one of the issues we spoke about yesterday is the overlap in the issues that are raised between this new technology and other technologies, genetic engineering, stem cell biology, even nanotechnology. And my question is in terms of the public debate and also the oversight framework, are we better isolating synthetic biology? Or addressing these issues in the larger context of emerging biotechnologies?
>> Well, I'll give you my opinion. I think there actually is a certain danger in creating different-ologies. 20 years ago, the U.S. Government made a conscious or unconscious decision, that our goal was to basically build another Industrial Revolution by gaining control of matter in a nano scale in a biologically relevant scale. We started with nanotech focused on inorganic matter and now moved to organic matter. This is about precision control of matter. That's going to change the way we make everything the next 100 years. This idea of separating things, one thing that was striking when you saw the slides, it mentioned nanotechnology. And so there's people up at MIT that actually reengineered viruses to make batteries. So the nano folks, they have been talking 10 years about self-replicating nano. Biology does that and we're in the position to program it. Drew mentioned this ability to recouple bits from atoms and program the bits and address them back to the world of atoms. So I think the national science foundation has talked for years about converging technologies, the nano and info and bio world. There is some value in thinking about the fact these are all coming together now and asking the question about, well, how will the regulatory system work? And will the toxic substance control act work well with nanotech and nano biotech because they are getting more complex. And you can do the same exercise through most of the U.S. statutes and U.S. agencies. I think there's attention there. Quite often it essential conceptually easier to break it down. But I don't think that's where we're going to end up in 20 years.
You are already seeing a tremendous kind of convergence. And there's also lessons to be learned, as we have already talked about I think.
>> Let me ask the audience if there is a question or two. Wow. A large number of questions. I'll tell you what. Why don't you collect your questions and then let them run through them? Give me your question and I'll note it down. Introduce yourself and then we'll turn our panelists loose on you. Please.
>> My question was for Dr. Schmidt. And it was basically is there a need for international standard for synthetic biology? But biotechnology in general as well.
>> Introduce yourself.
>> I'm sarhath Josey a student.
>> I am Gerald Epstein, I guess this is for David Rejeski. I have a pocket hobby of collecting policy studies whose recommendations include the president needs to make this a personal mission. In terms of the U.S. office or U.S. Government wide office, maybe related to the last. Does it need a special office? Or should it get in line behind other U.S. offices.
>> And what would be the priority of that?
>> Do we need a special one?
>> I am Nicole Gaddis from the University of Pennsylvania. My question is for Mr. Rejeski and Dr. Schmidt. I was wondering if there's been the ability to investigate educating young people before college and the impact of public perception on science advancing technologies or synthetic biology in particular?
>> Got it.
>> I'm Heather latey from the University of Ed inboro and I have a question from Mr. Rejeski and Dr. Schmidt as well. I enjoyed your focus on comparisons from Europe and the U.S. What do you think can be learned from what has arisen between Europe and the U.S. because this technology is going to fit into existing frameworks. What do we need to learn from what happens happened in the case of --
>> I'm very sorry. I didn't get good notes on that one. Slow down so I make sure I understand the question, please.
>> I was asking what could be learned from treating what has been learned between the U.S. and Europe as well in the case of genetic modification technologies and what can be learned going forward?
>> I have it.
>> Jim just wanted to hear you speak.
>> It was beautiful. Just beautiful.
[LAUGHTER]
Front microphone.
>> Hi, my name is Colleen Lyons. I have two questions. First is around the Belmont report as a values discussion. So I thought it was appropriate or I'd ask you how appropriate is that as a jumping point to investigate values in today's social context. The second thing is regarding education. What role can the House of Representatives play as a platform for educating their constituents? That's a general question.
>> Thank you. And finally in the back.
>> My name is Donald braman, a professor of law at George Washington university.
>> Yes.
>> And I'm a member of the Cultural Cognition Project and actually got to participate and collaborate with David Rejeski as part of the project and other work they have done. I wanted to second what they said with David and Markus said about the potential for polarization and the need for evidence-based science communication and deliberation strategies. Maybe I'll make it a little starker than David and Markus did. Deliberation can work and bring people together if done right. But done wrong, it can really push people to the polls and create a lot of conflict and polarization. So we're lucky to have generous funding from the national science foundation as they are doing research on just this sort of thing. There are plenty of researchers out there looking at how to do science-based education. I just urge the commission to make evidence-based science communication a deliberate and a formal part of their report to the President.
>> Appreciate ta.
You're with G.W. law?
>> Yes.
>> That's how we can find them. I was hoping they would converge into bins. There's at least one bin around communication and education. Thoughts about young people and focusing education toward them. The role of our Congress in educating constituents. And I think the comment there at the end. What about the education dimension of communications, gentlemen? Yes, Markus.
>> In one of our projects, in synthetic biology, we have one work package where we take film clips from Hollywood blockbuster movie that is have something to do with synthetic biology like forensic Jurassic park to find the sequence of DNA and make the dinosaur. It was science fiction in 1993 but not totally science fiction now. We took this and tried to combine it with scientific facts, what is possible right now, what could be possible in the future. Should it be done? What are the consequences? And make high school packages for teachers to be used in school. I think it's one way to engage people below university grade in this area. This is a general strategy in any new technology and also people that work in climate change and trying to to schools and inform young people. They are still open. A couple of weeks ago I was invited at a school, 14 years old high school students. And it was very interesting. I gave a presentation about the synthetic genome in the cell and the children were they interested. For them it was new. But as new as any other thing that was new. Actually, it was more surprised with the teachers, why are you talking to me? Is it real or is it a joke? The children understood it's not a joke. But the teachers didn't. They were more smart in grasping this.
>> Exactly. Wonderful. And options for educating Congress. And let's couple that with this question for a need for the White House level. Is that the right level? Should it have high priority here?
>> I think there is a tremendous need to obviously get Congress up to speed on lots of emerging technologies. I think before the congressional folks can educate their constituencies, they need to get educated themselves. So the Congress uses a system called caucuses. So for years, they had the nanotechnology caucus. We worked with them pretty intensively. And basically, they bring people in to brief members that are in the caucus. And I think that's a model that can be used with synthetic biology. One might even be able to build off the nano caucus. So I think that's a starting point. That gets the staff involved. It gets the members involved. And the caucus model is well-known in the Congress.
>> Thank you.
>> I mean I agree that we probably don't need another White House office. But one option, since we talked about this issue of things coming together, would be to build off the coordinating office of nanotech and do nano bio so we're not actually doing another office. We're kind of admitting this is where the science and technology is going. And we kind of expand that to take on some of the synthetic bio issues so we're not putting in place another White House entity, but just expanding it around this idea of converging technologies.
>> Final thing we heard from the audience was the international theme and the need for -- the question around the need for international standards. What can we learn about the existing conflict resolutions and agreements for genetic modification between U.S. and Europe. Perhaps we can even ask you to comment on the values of the report in this last grouping. Who wants to go?
>> I think what you find when you look internationally and not just the United States and Europe, both the biotechnology in general is certain areas of convergence of values in certain areas of divergence. So you have activities, you know, for example, this exhibit synbio, but you have in China the genetic engineering of human nucleus into a rabbit ovum and then taking a certain number of cells, which is something that wouldn't happen in the United States.
I think it is crucial as these technologies progress that we try to come to some set of international standards. While we can impose standards in our own countries and we can have multi-country agreement, it is undermined in these particular kinds of technologies, if there are rogue states, so to speak, that are doing things that are completely outside the bounds of the regulatory system set up by treaty or by agreement or even by some kind of international regulation. And so we have a very, very difficult problem of trying to figure out how to universalize a set of standards for scientific progress, as these technologies get so much more powerful.
>> In terms of technical standards, it is incredibly important. May I remind you one of the NASA Mars landers collapsed and they couldn't go to Mars because there was a misunderstanding between inches and centimeters which is very important. And the TARPOL project organized a meeting, a workshop earlier this year where representatives from the U.S. and Europe were sitting together in order to talk about standards and technical standards. But if you talk about biosafety standards, I think it's also important to have these. Also in relation to international trade, I mentioned one of the recommendations by the European group on ethics, the things that got imported or exported from outside the European union, they should be acceptable and fall under the European kind of laws and regulations. They have some countries that want to import or export into the European union have to adopt the standards and it would make incredible sense. On the other hand, I think I agree with you that standards should not limit exploration of new ideas and there should be some kind of diversity as well.
>> I agree with the need for the international standard setting. Let me take you in the other direction. We live in a large country and quite often, when there is some hesitancy by the federal government, state and local governments move, so the first municipality that put in place a biotechnology ordinance was Cambridge, Massachusetts. It's been in place since 1976. And there's 55 biotech companies in Cambridge. Cambridge put in place a nanotech ordinance, so did Berkeley in California, setting up their own system to take care of nanotech issues. We know from air pollution control, water, whatever topic you pick, you have a huge system. We have our own E.U. here. One of the things you have to be sensitive to is the fact some money may decide to move ahead of you. That drives industry crazy because not only do they have to deal with this aggregation at an international level but disaggregated markets at a local level. It's important to keep your eye on local government and states.
>> You're absolutely right. Can you get your questions answered at break time? I'd appreciate that. Let us, first of all, thank Dr. Wolpe and Schmidt. Thank you so for your contribution.
[APPLAUSE]
Wonderful. We will reconvene in 10 minutes, at quarter to the hour for the final session.
[Recess]
Commission members if you would please take your seats. We now move to our final panel of this day which will focus on current federal oersight and regulatory activities regarding synthetic biology and potential actions that the government could take in response to recent developments. This is the beginning of an overview. We will have time for deeper dives into this. As a commission, we will not be able to reach any conclusions about this part of our report until we have a chance to digest more of the science and ethics and social responsibility issues. This will at least begin to give us a sense of where our presenters see federal oversight as it is now. And will give us a window on to the state of federal regulation and oversight and give the commission members and the public to ask some initial questions. So let us begin. First up is Amy Patterson (NIH). (patterson intro goes here)
Thank you very much. Good morning commissioners and good morning everyone here today. I was asked to speak here today about the role of the federal government and the role of NIH in the oversight of synthetic biology research. I would like to spend a few moments on how science and policy have evolved over the last few decades and have brought us to the current oversight framework, and I'll spend a few moments talking about its relevance, the technological challenges for oversight, and some parting thoughts.
The caveat, before we turn back the hands of time. This timeline is in no way comprehensive, but it does present some of the key tech highlights and oversight relevant to synbio research. With the advent of recombinant DNA, we moved beyond the structure and sequence of DNA to the manipulation of that structure. The technology gave us new tools for understanding the avenues of life and developments of therapeutics and beneficial applications. The tech also prompted concerns among the scientific community and general public about unintended consequences, in particular on short term and long term effects on health. The tech also raised questions about boundaries between species and appropriateness of human kind manipulating the genetic code. During this time, a national dialog grew, about the role of public, society and legislature shaping the discourse in a free society. Several bills were almost passed, which would have placed restraints. This proved unnecessary. The scientific community, recognizing the depth of public cocern, and so on, they called for a moratorium on future research pending the development of an oversight framework. They assembled in 1975 and began the work of articulating the principles and practices that might govern the future of this research. There emerged one: the recognition of the inherit promise, and two the importance of an ongoing dialog and a development of public input and dialog. Three, the importance of careful risk assessment and oversight. Thus the foundation was layed for the oversight framework that was layed, and would touch on key points.
A national advisory body- the NIH recombinant DNA committee (RAC). It was to review each and every recombinant DNA suggestion at that time, and to articulate overarching principles and practices and biology and physical containment of recombinant DNA agents. The rpoceedings were published. A very deliberate decision was made to publish these as guidelines. In despite of the name guidelines, compliance was one and is a term and condition of federal funding.
In the emerging ease with which DNA can be manipulated and sequenced, and the coupling of this to human disease; a prior's president commission determined that the benefits of recombinant DNA tech also warranted continued exploration, but with thoughtful forward-thinking about the ethical considerations of recombinant technology and how it might be developed in the future. In an effort to embed genomics in day-to-day research, a program was established to adderess the ethical and legal research, and ELSI was an integral part of that. In anticipation of the first application of recombinant DNA in humans, the NIH guidelines underwent an extensive revision, and also to put in place a review process for each and every protocol that proposed hteu se of recombinant DNA in humans.
In 1986, the federal government issued a document on basic policy on the regulation of biotechnology products. Among a number of things, it articulates a principle that might be relevant here: the notion that genetic engineering products should be regulated by their intrinsic features, not their method of production.
The 1990s also expressed concerns about bioterrorism, select agents and toxins; the regulations for travel and transport; natural as well as recombinant toxins. The past decades have seen advances in our understanding of the human genome, but also our ability to design and synthesize larger fragments of nucleic acids. These experiments represent a continuum of research, and they enable important advances in vaccine development. They also raise profound questions. These advancements took place in the shadow of 9/11 and the dissementation of spores through the U.S. postal system. Concerns crescendoed through the misuse of biotechnology as a way to harm human health and national security. These concerns prompted a national policy dialog, and a national advisory board for biosecurity (NSABB). They have issued several reports about minimizing the misuses of biotech, including a code of conduct for scientists, and strategies for minimizing the risks of synthetic select agents.
The scientific community has again stepped up to the plate on a number of occassions. One case is synbio- they have convened in a series of ongoing meetings not only to discuss the advances in the tech, but also the important societal issues raised by this tech. From the 1970s to the present day, we've been probing and structuring DNA through genovo-synthesis techniques and other technologies. This has been a continuum of incremental steps, and coupled with the oversight evolution that encompasses synthetic biology.
I wanted to touch on the principles and attributes over the oversight principle. While biotech offers benefits, the potential risks must be assessed and addressed. Oversight must be predicated on risks. The framework is designed to reflect advances in science and advancements in our understanding of risks. But it is also designed to accept input from the public. The oversight framework is designed to account for accidental pathogen exposure risks, the general public and plants/animals/environment, biosecurity risks from the deliberate misuse of tech to cause harms; risks to human subjects, risks from adverse clinical administration; risks to societal norms, controversial uses or consequences of biotech, like germline gene transfer, or using GE to alter human traits rather than using it to treat human disease.
We don't have time to review these tables item by item. I will briefly touch on the overall categories. Biosafety risks are addressed by a variety of federal regulations and policies; essentially they speak to the handling and transfer of infectious agents. Biosecurity risks are addressed in statutess that are about minimizing the misuse of knowledge and the theft of biological materials that could threaten national security. There is also protection of clinical research; risk to society are to some extent addressed by these same policies. The NIH guidelines prehibit the use of germline research for in utero administration. The biologics and toxic weapons convention bans the use of this for mass destruction weapons.
The oversight framework acknowledges the responsible conduct of science rests on the behavior of individuals. Federal oversight can help cultivate a culture of responsibility. At the end of the day, this is fostered and nurtured at the local level. This oversight is also predicated on the biological characteristics of agents, hosts and environments. Be it recombinant DNA or synthetic biology, the important point is that it has the ability to grow new compounds and new species, and therefore brings difficulties in assessment. With synthetic biology in particular, the capacity to create increasingly novel organisms is at least in theory possible.
Another problem is the increasing ease with which you can order DNA over the internet. You can also purchase it on the web; but also reagents and automated equipment. The demographics of the practicioners of synthetic biologists include people from multiple scientific disciplines but also high school students. Synthetic biology is democritized, it's a globalized and commercialized industry. All of these features present scientific progress. It's a very open access environment, offering the hope for therapeutics and also presentation of major challenges for oversight.
We need to expand our ability to do risk assessment, characterization of biological properties, in the context of the tech. The U.S. Government is continuing to refine the oversight framework. We are very visibly at owrk, we have a lot of work to do. We are all on the slippery slope of the learning curve.
The NIH guidelines are currently under revision to improve basic and clinical research about nucleic acids. This would be an oversight framework for the local and federal level for the review of these experiments.
Also guidance for the providers of double stranded DNA, how to screen orders, and policy on the local and federal level for the dual-use of knowledge, the potential misuse of these techniques. This is well underway, based on the NAASB recommendations, which will be applicable to certain types of synthetic biology experiments. The US govt recently tasked NAASB on strategies on outreach to practicioners on synthetic biology, enhancing the culture of responsibility and engage the international community.
The U.S. government is exploring the way that the framework could be enhanced ,to reliabily predict the action of agents and associated risks. We have commissioned a study from the National Academy on this very topic. And as recently as last week, our president issued an executive order to strike a critical balance between biosecurity and scientists engaged in legitimate research on select agents.
The oversight framework has evolved. The field of synthetic biology continues to present new challenges to oversight. Oversight can never be "business as usual". And scientific progress is predicated on trust- open, transparent dialog that encompasses frank deliberations about uncertainty, unintended consequences, and societal norms. This committee can provide a forum for enhanced understanding, applications of this tech, future uses, and what it may mean for society, and the future of the oversight framework and its evolution will require this.
The price of scientific freedom is eternal vigilance and scientific responsibility.
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Michael Rodemeyer
Thank you very much. It's a great privleedge to be here with you this morning to talk with you about the current regulatory system and how it would likely apply to the first generation of syn bio products. As Dr. Gutmann recognizes, this is largely from the work for the Woodrow Wilson Center, which was from work with Pew.
In general, since it's difficult for a lawyer to say anything in 15min, my concluding thoughts are: the existing laws and regulations that cover biotech products are likely to apply to the first products of synthetic biology. SInce the first generation of syn bio products are expected to be very simple, and not different from the genetically engineered products that agencies are familiar with, it is not likely to present new challenges at first. As the organisms become more complex, artificial and novel, the challenge will be to assess the risks of the organisms in advance, especially for organisms in the environment. Regulatory agencies will be in a difficult position to make decisions that balance benefits, uncertainties and potential harms.
There is a deja vu quality to all of these discussions. Much of this happened in 1976 following the development of recombinant DNA tech. While there are differences between the tools in synthetic biology and recombinant DNA technology, the kind of risks that regulators are interested in (when it comes to biosafety), that's what we're talking. We're talking about biosafety in the lab, like the accidental release of a pathogenic organism, that might infect laboratory workers, we're talking about the environmental concerns that Dr. Snow talked about, like in unintentional as well as intentional release in the environment. Also concerns about final products, like using synthetic microbes to manufacture chemicals, drugs and foods, how do we know those final products are going to be safe?
I will be talking about the existing systme of biotechnology regulation. As Dr. Patterson has indicated, the NIH plays a critical role in regulation of biosafety conduct in research labs. This is not unique to engineered organisms. We need to deal with a huge range of infectious and dangerous organisms. Engineered organisms pose particular issues. How do you determine in advance the potential risk of the organism in order to know which level of biosafety you need to put in place?
For recombinant DNA tech, that's pretty simple. You find the gene segment, you determine the function based on natural knowledge. Synthetic biology makes this more complicated: synthetic microbes could be assembled from synthetic genomic parts that were constructed in a lab or from multiple other organisms. The engineered microbe could show emergent behaviors. While unlikely, an engineered organism might have riskier behavior than just the sum of the parts. Dr. Patterson has guided people at the NIH over risk characterization. Commedably, they are moving ahead to cover synthetic biology research as well. The challenge will be to develop guidelines that are cautionary, without hindering research with expensive regulatory requirements. Whether these guidelines work will depend on insitutional biosafety committees at research labs that have the responsibility for implementing them.
The research not covered by NIH guidelines - privately funded researhc- is this a problem or not? In 1980s, as the first products of genetic engineering began to move out of the lab and into the production. The oversight framework was wondering what to do about this. So, as a result, the office of science and tech policy in 1986 led an inter-agency process to develop a framework forbiotechnology products. These policies are still in place today.
There were three basic findings of that group that are relevant to us here: (1) the decision that the process of biotechnology process itself is not inherently risky, no more riskier than conventional breeding, and therefore (2) regulation should be based on the characteristics of the final product and not the process that it was made. (3) Given that, the existing laws could be used by US regulatory agencies could be used to regulate anticipated risks from the products of biotech. The question of course is, how well has this regulatory system been put into place?
The way that it has evolved is (1) the US and this is not a model that has not been followed around the world (it has not been followed, I mean). The drugs are regulated by the FDA regardless of how they are made; pesticides by the EPA. Microbes and plants for environment are reviewed for pest problems by the department of agriculture. Despite this general principle, regulatory agencies have had to engage in legal slight of hand to fit biotech products into existing regulatory schemes, which were written before biotech came along. In some cases, agencies are still trying to adapt regulations to fit new tech. EPA had to figure out how to regulate a corn plant as a pesiticde. The FDA had to regulate a genetically engineered salmon under animal laws. The USDA had to figure out how to regulate a soy bean as a plant pest.
Some of these creative legal interprretations could be challenged. The ability of the agencies to regulate this under these regulatory committees. Biotech companies have every reason to cooperate with these agencies rather than confront them. This tech-neutral issue is interesting. Under US law, some products are viewed as inherently risky, and are therefore required to go through a pre-market approval process (agencies must find this to be safe before marketing). Animal/human drugs, pesticides, food additives. Most products intorduced into the market get little to no pre-market regulatory review. Manufacturers have to be responsible for safety. If you want to make a dietary supplement via synthetic biology, you get the same regulations as other dietary supplements (which is very little).
Different products get different levels of scrutiny. There is still a difference of opinion over the last 30 years. A number of groups believe that the system is not rigorous enough. While others believe that biotech products are over-regulated, and keep beneficial products off of the market.
If you had a blank slate, you would not design this system. On the whole, the system works. Valuable products have been introduced without evidence of harm or environmental problems. One could argue that we're just lucky, or we're just not looking hard enough for problems. That's probably true, but overall the system seems to be working. The US is unlikely to change its policy positions that have been in place for 30 years. How would this framework apply for synthetic microbes and drugs and biofuels?
Do the laws give agencies authority to cover this? Other agencies have had to stretch their legal authority. The USDA and EPA will need to revise their regulations in order to cover synthetic biology products. Existing laws are likely to provide agencies with sufficient authority for new products developed through synthetic biology. The FDA has been allowed to look at the process of manufacturing of these products. The real issue, the more important question is, whether or not the agencies have the resources and tools they need to both assess the risks and to also manage the risks as well.
The first microbes from synthetic biology are not likely to be appreciably different, and there's no reason to think they are more risky than products before. As the tech develops, it will be more difficult to assess the risk of potential impacts. Risk assessment is critical for regulatory agencies, which determines the level of containment, monitoring and control for commercialization of a product. Getting this right, by over-regulation and neither under-regulation, is a major challenge.
It may be a difficult thing for the EPA under the toxic control act. There are some laws pending in congress. It might make it difficult for the EPA to attain the information it needs for more assesment. Since risk assessment is more likely to become difficult, there needs to be controls for the unintended control of spread ... unintended spread of the microbes in the environment. Actual function of these microbes in the environment. Our experience to date has not been good: it's hard to keep biologically active materials separate in the environment, we've had instances of finding widespread gene flow from GM crops, etc. It's critical that such tools be developed publically, tested publically, and tested widely, in order to avoid controversies of terminator technologies in the context of GM crops.
Everything that I have talked about this is irrelevant to the garage biology phenomena. Regulations that I am talking about presume an industry that has the capacity to comply. In the case of people doing work in their backyards or garages will be likely to not know that they need to file a permit or something. We do not have a satisfactory model for this.
(1) The federal government needs to conduct a full and transparent review of the authoritoes, tools and resources to assess and manage the risks of synthetic biology. The recent DOE grant to the Venter Institute hopefully can provide a process for beginning that assessment.
(2) Federal funding agencies should fund robust risk research on synthetic microbes so that regulatory agencies have an independent basis on making regulatory decisions. Funding is also needed for developing and testing the conditional releases of organisms. Unless the risk research keeps pace with tech development, agencies are likely to respond to this by over-regulation, and keeping beneficial products off the market. Such research needs to be done in an open way.
(3) Finally I would recommend that the government needs to meet with stake holders- local governments, the do-it-together community, to begin to discuss rules and regulatios and so on that applies to all players.
Synthetic biology and synthetic genomics offers a lot of promises about our health needs. Providing a regulatory regime is a key part in assuring that society receives maximal benefit.
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Edward You. Weapons of Mass Destruction Unit.
Thank you very much. I want to thank the commission for inviting the FBI to present today. Being last, I have the advantage of building on the previous presenters. Let me start on building on Dr. Patterson on the AASB recommendations. These are very relevant. They have reports on biosecurity concerns related to synthetic biology, dual-use issues, and most importantly, the outreach and education component of it all.
I would like to bring to the commission's attention, the national strategy for countering biological threats. I have included some of the highlights: norms for responsible conduct, emergent risks, taking reasonable steps to reduce the potential for exploitation, and also international progress.
I do want to caveat right now that the FBI is not a regulatory body, but a law enforcement agency. In light of 9/11 and the anthrax mailings, we have taken a pro-active stance now. Through the consolidation of the WMD units, we have countermeasures/preparendess, intelligence for chemical/biological/nuclear threats. From the bioterrorism prevention program, these are our goals here, mostly operational to address bioterrorism.
Scientific industry and academic outreach. Why is this the case? When it comes to synthetic biology, how do you engage the different communities about biosecurity? The commission has seen that synthetic biology is difficult to define- academic to your amateur biologist. They are very different cultures.
You're dealing with advancement in technology on different levels. Not just the agencies, but also the participants. While the FBI has a responsibility for maintaining homeland security, we understand that any biosecurity program has to ensure there is not a negative impact that impedes research on all of these different fronts. That would present a national security risk, because you could impede countermeasure and biodefense research and more important entrepreneurial efforts that are going on as well. Striking that balance.
In 2006, the NAASB came up with a report on the illicit acquisition of DNA sequences coding for dangerous toxins or pathogens. The synthetic DNA companies in the US and actually instituted best practices in looking at how do you screen your customers and incoming sequences to make sure that risk is addressed. The FBI took the NAASB recommendations and ran with them, and conducted outreach with these companies. Although they do their due-diligence, if they come up with the red flag, what do they do? By conducting the outreach, the FBI engaged the WMD core, these are special agents dedicated to this- there's one in every one of our 56 offices. You can contact your local coordinator, where we have some subject matter experts at HQ, so we can contact the CDC and so on.
As I highlighted there, the industry was very happy about the question of "who to call" was resolved. Dr. Patterson just mentioned that recently the draft for screening guidance was released in November. This came out of NIH. Screening recommendations, government notification recommendations. This gives some DNA providers some recourse for what to look up and who to contact, the FBI, or export considerations (like Dept. of Commerce). This is all voluntary as well too.
The FBI hosted in August 2009 the first synthetic biology conference in San Francisco. We did this with the state department, AAAS, and at this event we had communities like diybio, academia, to come together and talk about the state of the art, but by having a law enforcement presence, can we come up with a meeting of the minds, can we come up with the risks, and managing or mitigating those risks, without impacting their efforts? It was overwhelmingly received. The FBI gained a better understanding of what the different communities represented.
This also on an international level, Dr. Schmidt mentioned the International Association Synthetic BIology. They instituted a best practices workshop in November 2009 to look at customer and sequencing matters, and a code of conduct to codify these best practices. The UN Biological Weapons Convention and US State Department were in attendance, and they looked at how we could assist in perhaps translating this notification process of the FBI to an international level.
And then we talked about iGEM, it's an undergrad competition hosted by MIT, and this past year in 2009, there were 1022 attendees, 26 countries. It's an undergrad competition and the director of this competition (Ruttberg) - I can't state this enough. It's fun. It is fun. It is all about synthetic biology. It's amazing what these teenagers can do in a 3mo time period. They come to MIT and showcase their summer projects. The FBI was at this last igem. Because of the national component.
Why is the FBI here? That was the first question. But because the international representation, we invited the UN to bring representatives. We hosted a workshop and had an outreach booth. To promote responsible research. In this instance, it was outreach, not oversight, and it was blue genes, not men in black. And then, DIYbio had a formal conference at UCLA. They talked about their state of the art, where they stood, citizen science and the expansion of the community.
And they got the .. and to the credit, they invited the FBI to come in and give a presentation and promote some career opportunities as well. Just recently, the UN Inter-regional Crime and Justice Unit (UNICREET), had a nanotech/synbio response. It is a parallel of what the commission is doing here. They brought on board all sorts of people, and the UWNBC, to look at biosecurity implications, and then hopefully come to some possible response measures or policy recommendations.
The report is due out this September, so that might be something the commission might want to take into consideration. Also, just recently, the FBI co-hosted with the Massaschussets Society for Medical Research its first biosecurity conference. This is a conference that had academia attendees, and representatives from institutional biosafety committees, institutional animal care and abuse committees. These are the gate-keepers, they are the ones who make sure the NIH guidelines are followed. They look at ethical issues on grant proposals. At this conference, and all of the conference people, we brought to the academic level, what do we mean by biosecurity?
By working together with the research community, can we come up with ways addressing biosecurity and so on? In a way that is not impacting research and commensurate with the identified researchs? The majority of the attendees said that any future biosecurity trainings should definitely have FBI or federal participation. It was really great. Um, and as we talke dabout over the case of a day and a half are terms like dual use, physical security, exploitation, material handling, all of the FBI activities are looking at fostering a culture of responsibility. It's empowering the community members themselves, what do we mean by biosecurity, help them to self-identify what some of the risks and harms could be? And working together to manage those risks.
I want to share an anecdote. It is not difficult toe ngage these communities. One professor - Jean Preclude from Virgina Tech. He's a professor in biotech. When he received an invitation to synthetic biology with the FBI, and he figured that he would go, and he listened to the message, took it to heart, and at Virginia Tech, he invited the FBI to come down and give a biosecurity workshop but not just for the bioinformatics college, but for the entire campus and four other universities, and undergrads all the way up to faculty and administration like vice president of research and compliance. It was a great success. It was a great success story. At the end of the day, I will never forget this, there was a sophomore student, and at the end of the message, she stood up and asked "I udnerstand, what can I do?" Through iGEM, the outreach that we have for the faculty members, we are equipping them to become the next generation of synthetic biology researchers and entrepereurs to understand that these issues should address.
We're fostering the development of this culture. On the facutly side, we're helping them become good advisors for these areas. What's the role of the FBI? As I said, there are certain identified and yet-to-beidentified threats. The FBI addressing the threats, that's our job. Engaging the scientific community, our job is to engage them and provide them the education to have situational awareness, to empower them from industry academia all the way down to DIYbio, to address these threats and that they are out there, and within the community potentially, but it doesn't stop there. It's a two way street, there's communication back to the FBI, not just a 911 call, but basically to help us, and as we mentioned, this is - syunthetic biology is screaming forwartd into the future. Not only from the FBI side, but from a policy making side, it's going to be difficult to keep up with the state of the art. We're helping to guide them, and make sure that we're aligning our resources commensurate with the risks, not only makes sense to national security but also the constituents that make up the scientific community.
Mitigating the risks, conducting our reach, partnerships not oversight. Effective policy making. The FBI and our federal partners can advise bodies like yourselves to make policy recommendations. More importantly, to get engagement from the scientific community, to get them toa divse you.
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I have a vivid imagine of agents in jeans advocating teens to do DIYbio. I am going to ask Jim Wagner to ask our first question. Wonderful presentations, thank you. I have a quick question. Dr. Patterson, I understand, and it was re-iterated, this notion of basing regulatory focus and activity on product, performance, and several other words, organisms, the objects. I am comforted that you feel that in the near term, with a little bit of extension with our current regulatory regime, we're in pretty good shape. I found it striking that it was Agent You who focused on something we heard yesterday: part of the distinguishing element of synthetic biology apparently is that so much of it is information, coded sequences. It's not in product.
Do we imagine that the other dimension that needs to be added to the regulatory regime, using your language, is something that would address not just product and performance, but also early stage information and its exchange?
I think that this is in terms of where the regulatory agencies come into play. Again, it's a reactive system. Essentially, the agencies wait for industry to develop products, that they need to move forward with to get regulatory approval. So, agencies are not generally in the position of going out and trying to get, even though there is an effort to track what's going on, so they can anticipate what is about to happen, unless there is a legal requirement to come to them for some regulatory review, the fact that there is previous work beigng done is not something likely to engage the agencies. This would fall within the NIH.
I would like to add a couple of comments. First of all, genetic sequences are overseen. Let me give you a few examples. On the biosafety side, genetic sequences are looked at for their capacity to replicate or encode. The constructs themselves, there is an oversight framework for how they are used, handled and distributed. On the biosecurity side, the select agent rules have a genetic section. There is regulatory oversight for genetic sequence. What can that genetic encode? Can it encode an infectious form of one of the pathogens that we are concerned about? Can it encode one of the highly lethal toxins? It's the subset which could potentially encode a pathogen.
Follow-up question. You were very I thought clear and open in your presentation that we have a set of regulations in place and practices but to quote, the American philosopher Will Rogers, even if you're on the right track, if you just stand there, you will get run over. We need to think about where we have to move, where the gaps are. Can you just say a little bit about the gaps? I know you can't be comprehensive, but where are the gaps when you look at synthetic biology?
I think many of the speakers have touched on the major issues - the notion of uncertainty, and as the constructs become more novel, we are unable to extrapolate from what we know to what these are. The question becomes, is the construct or the new entity guilty of being pathogenic, or being innocent until we have data? How do you treat it in the interim where you don't have data? Will you treat it with maximum controls? It's a conceptaul framework for how we think about these things, and move forward in a responsible way.
I want to follow-up on that question. Both Patterson and Rodemeyer have made the case that synthetic biology is part of the continuum of what has been happening with recombinant DNA and so on, for the past 35 years, and also talked about how the NIH pomigigated guidelines for using recombinant DNA. How other agencies came in and began to implement a strategy for even those institutions not funded by the NIH. One of the questions I have is, do you feel, based on what we're hearing, that we have an adequate infrastructure to examine these issues in synthetic biology, and do we have the ability to promulgate the right guidelines, or do we need a new infrastructure that lead to synthetic biology?
I don't think it's a politically realstici thing to talk about a new regulatory system for synthetic biology. I think this is the system that we have. How do we improve the system to make sure the challenges by synthetic biology- how do we build in better capacity for this system to be able to deal with it? There are any numbers of relatively small things that could be done in terms of agencies writing regulations that making sure that information is obtained, and incentives for industires to develop this kind of information as these products are being developed as well. So that information is made available. The system is adequate in thes sense that the real concerns - the real concerns about the resources and tools that the agencies have. It's difficult enough for them to deal iwth the fires that they have to put out today, having them think about 5 to 10 years down the road is really asking too much. The system is adaptable enough for them to grow and change as they learn. I think that we shouldn't throw out the baby and the bath water.
I would agree with what Michael has said. I would also remark that if one were to take the blank slate and design an oversight system, in my view, again, the three attributes would be (1) the ability to foster the beneficial applications of technology while minimizing the risks and managing the risks, that there would be a role for society in input into that infrastructure, and to cultivate public awareness and understanding, and (3) that the system could evolve. While I think that the government isn't good at cultivating public awareness and understanding, we're not always the best but we try, those three components are present in the current system. But it needs to evolve. The most important things it needs are the tools for appropriate risk assessment. Another question to ask is the applicability across all sectors, we see this technology is widely available, it's practiced on academia, not just dependent on streams of federal funding, but it's also privatized. Our relationship to other countries, and our citizenship in the world, is the question of how or what position the US takes with oversight with respect to other countries, and the degree of international engagements on these issues.
My question to the three of you is the follow-on. It seems to me, based on all three of your presentations, that you discribe a similar context that has been evolving over 40 years, you describe in your presentation that you thought there was adequacy, even though you wouldn't choose to build this particular framework, and that it has stood up to challenges. The FBI seems to be the answer to a question raised yesterday- who is the 911? They are actively engaged so that the 911 entity will stay up with the state of the science. It's definitely improving its ability to survey and become part of the field.
What I am wondering is if the existing regulatory or federal bodies that need to exist simply need to add this as a mission, perhaps not creating a new office, or adding this mission to their existing federal system so that there can be a quick learning period and the ability to make the quickest impact in a field that is evolving quickly? Adding a mission, or creating a new framewrok?
I think it's evidenced by the fact that the FBI as I mentioned, we are foremost a law-enforcement agency. In criminal investigations, it's reactive. If anything is better testimony, is the fact that we're proactive, as adding a mission. As evidenced, it is possible. I cannot comment on from a regulatory standpoint, but at least from the FBI standpoint, the mission has changed and has adapted.
Two comments. First of all, I think we have underscored a theme, a continuum here, but also the caveat that should not make us complacent. I think I can speak on the behalf of my colleagues at other federal agencies. We think a lot about these issues. We look forward to the input to the commission; complacency and turning a blind eye to what might be novel would be a mistake. Synthetic biology is within the mission of biomedical research and much of the oversight framework that we have today we've tried to bring togehter, the NAASB, the recombinatn DNA advisory committee for a joint meeting for examining the state of the science, top-down and bottom-up, and examine current issues, horizons, and what we can't see - biosecurity and biosafety risks. We are actively trying to engage an international dialog, we have 11-enrs, the first one was in the Americas with PAHO. We're just about to do one-- these are webinars. Online interactive sessions where the notions of dual-use synthetic biology are discussed and people could log-in and call in, we have one coming up based in Europe in the fall, it features synthetic biology. We have one later on in the year in China. I just say that to try to underscore that we're trying to address these issues. I think they are very much within the current mission of many offices and agencies either implicitly or explicitly and increasingly explicitly.
I have - I would go to Anitya then Christine then Barbara. Thank you. Uh, assuming that proactive government and law-enforcement oversight is appropriate, I want to ask a friendly version of a question, which you might get as unfriendly. My intention is friendly. What concerns or push-back or resistance might you expect or have you gotten from the idea of govbernment oversight from researchers? Concerns about academic freedom, intellectual freedom, industrial business secrets, civil liberties like freedom from surveillance. The push-back from the academic setting, when the government began to regulate encryption controls and so on. What sort of push back have you gotten or do you anticipate about academic freedom and intellectual property?
I guess that's my question. Again, our outreach activities have been relatively new. There has been some initial pushback. But I think that when we come in, and I addressed this in my first slide, how do you engage the different communities? The industry representatives- not the same way to approach someone in the DIYbio community. The message is still the same. There are some inherent risks and potential threats, but by working together, can we manage and mitigate those risks, what's the flipside? If there is an accidental release and so on, that's probably going to happen.. but engaging with academic, they understand it. One of our engagements is where we have a table top hypothetical scenario set, with hypothetical release and so on. WE have someone from academia and someone from law enforcement. The representative from academia now understands the role of law enforcement. It makes the message that much more understandable, but then it doesn't stop there, it's that- for instance, an accidental release from a law-enforcement side, from a criminal standpoint, we're done, if it's an accident. But we gain the appreciation, if you're the university, now your funding might be at risk, all the liability issues, that's just the very first step. So, there's an appreciation from both communities, both from the intentional aspects and also from the accidental aspects. The different scenarios, by gaining an understanding by different communities is vital. The pushback decreases.
I am hearing proactive education, proactive risk assessment, and question as to whether we can do that, whether you all can do that, without a crisis, before a crisis happens. Christine?
I wanted to ask a question in light of the questions before. Do we need to change regulations? One of the things Amy said is that the ideal situation would be a system that is easily evolvable. Being a federal employee, we work hard to make things respondi, but the federal government is not known for speed and changing or reacting to new fields. This synthetic biology depending on how you think about it, is moving pretty fast, maybe not as fast as some would like to think, and speed is an important thing to think about. Is there anything to think about in terms of how the federal government would think about having to evolve faster than it currently does given the current structures? And slightly different, how about coverage? Who do we reach out to, but what else can be done at the governmental level to reach constituents that it doesn't normally reach.
For your first question Christine, the strategy of embedding in law and regulation the overarching principles, like the products of biotechnology or pathogens should not be misused to threaten public health, or regulations that ensure the safe conduct of research, and then setting forth the specific procedures and guidance and practice, so you have the standard, but the way it is achieved can be more rapidly evolved and tweaked as new data comes in, our data is enriched, how we go about embodying that goal and statue is achieved. We need the flexibility to have oversight tools that change in that fashion and yet uphold the principles. We see this in the select agent rules that speak to knowing what you possess, transfering it, and registering it, but the voluntarily guidance to synthetic double stranded DNA providers, how do they go about screening or knowing what they made? That's embedded in guidance rather than embedding it in regulations. That would be my thoughts on that balance.
We heard yesterday about licensing at various steps along the process as a way to monitor. I am not concerned about the NIH- they have a fair number of areas of scrutiny- but by industrial uses - and amateur uses. Would it be valuable or not valuable to have licensing of products or steps along the way and the bioterrorism issues and the ones who are not licensed therefore being subject to some other ergulation?
With our engagement with the DIYbio engagement, they are taking that into serious consideration. Some of the things they have considered is model rocketry for instance. There are over-the-counter products, where you can just take it and launch it, and there are more - the example they show, last year, an amateur rocketry enthusiast built a 1/5th scale model rocket and had to get FAA clearance, and all of the permits and licenses. They are likening a safety and security framework around this. Drew Endy mentioned amateur radio. They understand what the impact could be, if something could go wrong, they understand how it could effect not just the community but the perception of the community. They are taking into serious consideration, how it would flesh out would be where it's extremely important that we engage the different communities. It will not be a one-size fits all, it might not work for amateur communities but maybe the industrial communities.
I am going to. It's a testament to everything that you have told us, and we are going to engage you more. We are going to the members of the public now for questions so we can address some questions to our presenters. And, um, go ahead. Yes, go ahead. We should take a few, htis is our last session, it's our last session for this meeting, it's not our last session. Please introduce yourself and ask a question, and I will keep track.
I am with Friends of the Earth. I am going to go with Dr. Patterson and Rodelemeryer says with moving forward with the synthetic organisms. Where does the burden of proof lie with analyzing risks, to prove research, do we let them go forward and be reactive if something bad happens?
Rob Carlson. I am concerned of two comments. I am concerned that the words of regulations and licensing have been used casually these past two days. And would observe that the press coverage would lean on regulation and not bioethical issues. The reason I am conferned about this is that nobody has talked about the costs. It is assumed that regulation and licensing equals safety, and it is demonstrably the case that safety and security are reduced with regulation. This issue has two sides, and we don't want to make it worse. The final comment is that the national strategy for countering biological threats that Agent You put up[, the first sentence of the second document says that garage biology is good.
I am director of Texas Tech University law for public policy or something. I would like to address a question about gaps. Many of these that come to mind are a lot of the things are oversight mechanisms but they apply only to people who have government contracts, they are spending the money as part of the oversight. The broader picture and broader public, that should probably be addressed. If we can learn lessons from legal history, the governments and states may fill in regulating at that level, it would be a point to good to address. Another point is the speed, and that's a relevant question when you have a technology emerging as quickly as this one, and if I had the opportunity to ask the agencies to look at this, I would ask them to inventory what existing regulations apply, and then secondly issue a guidance about how synthetic biology applies, guidance can be non-binding for the regulated community. So I would suggest two things that I might say would be really good steps forward, assess what regulations exist, and then issue a letter of guidance. The big picture, I think, also, I learn from lessons, and I had a walkthrough the legal and scientific history of biotech. The tension that we have explored in the last two days is the need between regulatory oversight and against the need to optimize development without unnecessary impedance. So also ethical and value constraints. This is not a luxury but a necessity, it's doing exactly what should be done today.
I have a question for Mr. Rodemeyer. I am an environmental journalist that has written on genetic resource access. All of the presentations were nelightening, I have a question on federal review. The international connects or disconnects. For instance, gene flow from GM crops, that's an important management issue, and it's an international issue. Within this question, implicit international agreements.
Where does the burden of proof lie? What do we take the costs of regulations into account? And international- how do we factor the international community I'll leave that to anyone who takes that.
The burden of proof is really set out by the various laws that apply to products. For instance, if you are a drug manufacturing, the burden of proof to safety is on you. The agency will deny it until it is proven to be safe. In other areas, the government is burdened to prove risk to justify regulation and enforcement. It is an open question, as to where in the variouis risks, where synthetic biology, what would apply? Good.
When it comes to the oversight of research, assuming that there is a standard or regulatory standard is in place, then the burden of proof is on the researcher to prove that they have adequate evidence and proof of concept that supports for moving forward. So, as to hte cost of regulation. When regulations are promulgated, there is an economic analysis that is done with them. The burden of regulation is assessed and published with the recommendation. One could quibble about whether the assessments are accurate,do they capture the costs, or do they overlook costs? So the costs of regulation are important, so I agree with the gentleman who offered that. There is a cost in not regulating. Both need to be considered.
The commission's perspective: we will not assume that regulation is justified or not justified regardless of the cost. That to us is an open question. Rob has been reading the news articles more than we have probably, since we haven't had a moment in the past two days, whatever they say, I want to put it on record that this is something that we would definitely consider, the cost factor is something that we would consider. These are really important questions, when we're not going to do the deep dive today, but perhaps the question on the international community.
There are two aspects: biosecurity issues are critical and I will ask my colleagues to respond to that. On the regulatory side, this is has been a real challenge because we have a global controversy about genetically modified crops and foods. Other regulatory systems are based on process-based, and we have this problem of asynchronous regulatory approvals, where products are legal here, but not in another part of the world. This is difficult with a commodity like corn. These issues are engaged at international levels, there have been efforts to harmonize efforts between the nations. It's a complicated answer. There is no clear response, no clear one place where you can kind of bring all of those issues together.
Mr. You. I would comment that the FBI does have intenrational engagement such as through INTERPOL and the UN, but also the US State Dept. has an interntational bioengagement strategy, and that question could be addressed through that level.
We have reached the end of our time for our first inaugural session. First, I just want to say, uh, a simple observation, uh, the number and diversity of members of the public who have turned out, is truly heartening for anyone like myself that believes education first and foremost is at the heart of a lot of the issues that we face in our democracy and secondly it's a testament to how many members of the public stayed till we are adjourned. Let me just say a few words and ask Jim if he would like to say anything. FIrst, we have issued a call for commentary on the topic of synthetic biology. Any group or individual that would like to offer opinions on the topic, we will read them. Check our website, our website is
www.bioethics.gov and our email address is
in...@bioethics.gov - so, on behalf of the commission, I want to thank you all for coming. Our next meeting is being held September 13th and 14th at the University of Pennsylavnia in Philadelphia. All of our meetings are open to the public and free, and our meeting after that is in Atlanta at Emory. I will now turn it over to Jim.
Let me thank everyone and our experts throughout this session. This has been fabulous. Thank you to the public and please contribute through the mechanisms provided. Thank you for two days of excellent discussion and deliberation, it will serve us very well. Thank our three presenters who did a marvelous job.