Ethical Issues in Synthetic Biology An overview of the debates

SYNBIO 3 / JUNE 2009 Synthetic Biology Project / S YN B I o 3 Contents Preface 3

Executive Summary 4

Who is doing what, where are they doing it and how is this current work funded? 6

How distinct is synthetic biology from other emerging areas of scientific and technological innovation? 9

Ethics: What harms and benefits are associated with synthetic biology? 12

The pro-actionary and pre-cautionary frameworks 18

n overview of the debates A n overview of Competing—and potentially complementary—views about non-physical harms (harms to well-being) 23

The most contested harms to well-being 25

Conclusion: Moving the debate forward ...... 26

References 29 ethical issues in synthetic biology: ethical issues in synthetic biology:

ii The opinions expressed in this report are those of the authors and do not necessarily reflect views Sloan Foundation. Wilson International Center for Scholars or the Alfred P. of the Woodrow Ethical Issues in Synthetic Biology An overview of the debates

Erik Parens, Josephine Johnston, and Jacob Moses The Hastings Center, Garrison, New York

SYNBIO 3 / june 2009 n overview of the debates A n overview of ethical issues in synthetic biology: ethical issues in synthetic biology:

2 Preface

Synthetic biology will allow scientists and where such topics are divided into two broad engineers to create biological systems categories: concerns about physical and non- that do not occur naturally as well as to physical harms. While physical harms often re-engineer existing biological systems to trigger debates about how to proceed among perform novel and beneficial tasks. This researchers, policymakers, and the public, emerging field presents a number of non-physical harms present more difficult opportunities to address ethical issues early conundrums. These non-physical concerns and proactively. range from equitable distribution of benefits to fundamental beliefs about our place in the With synthetic biology, scientists are literally natural world. getting to the basis of life itself, but concerns about whether or not humans should be Ethical concerns are too often addressed “playing god” are only part of the equation. after investments in science have been made Concerns have already been voiced about and technologies are already mature and patents, oversight, and possible inequitable in the marketplace. At that point, neither access to new and potentially powerful the research community nor policymakers synthetic biology innovations in areas ranging have a strong incentive to address ethical from medicine to energy production. issues for fear that any debate may stifle technological advance and innovation. But This report by Erik Parens, Josephine Johnston, given the rate at which new technologies are and Jacob Moses of the Hastings Center, a emerging and converging, this paper argues bioethics research institute in Garrison, New that a comprehensive ethical approach is York, presents a framework for addressing needed early to best foster the wide public the social and ethical issues surrounding the acceptance and support of new technologies emerging field of synthetic biology. The paper such as synthetic biology. explores current frameworks for evaluating ethical issues and proposes an approach —David Rejeski Director, Synthetic Biology Project

3 Executive Summary

• To advance knowledge and create • As emerging technologies converge, it • We can expect that ethical concerns will products that can promote human becomes clearer that the ethical issues arise with the advent of any emerging welfare, synthetic biologists seek to raised by these technologies are at technology. These concerns can crudely create biological systems that do not core similar and familiar. It would be a be divided into two large categories: occur naturally as well as to re-engineer waste of resources to take up the ethical concerns about physical harms and biological systems that do occur naturally. questions in parallel; i.e., it is not profitable concerns about non-physical harms. to invent a “new kind” of ethics for each Because “non-physical harms” captures • Synthetic biology can be considered an new technology. Instead, we need to get such a wide range of concerns, it can extension of genetic engineering, which, better at productively engaging the familiar be helpful to further divide non-physical as it advances, will increasingly converge ethical questions that cut across those harms into two groups: those that seem with nano and information technologies. emerging—and converging—technologies. to have gained traction among the Several putatively distinct areas of It is time to go from speaking about researchers closest to the action (e.g., emerging science and technology are hyphenated ethical enterprises (gen- concerns about how to fairly distribute n overview of the debates A n overview of converging, making it ever less useful to ethics, nano-ethics, neuro-ethics, synbio- the tools needed to do synthetic biology try to draw clear borders among them. ethics) to speaking about the ethics of and how to fairly distribute the benefits of emerging technologies. synthetic biology) and those that have not gained traction among the researchers and scholars closest to the action (primarily concerns about the appropriate attitude to adopt toward ourselves and the rest of the natural world). ethical issues in synthetic biology: ethical issues in synthetic biology:

4 • We can also anticipate that people • So far, the literature on synthetic biology • There is a need to identify and engage will often (though not always and not contains significant work on safety and with both physical and non-physical necessarily) think about these ethical security (i.e., physical harms), in which the harms, including those that are deeply concerns using, crudely speaking, two pro-actionary stance has been winning contested. Such an engagement will lead frameworks: a “pro-actionary” or a “pre- the day. That literature also shows some to greater mutual understanding, which is cautionary” framework. People using recognition of the importance of the first both a good in itself and carries practical each framework can give reasons for their kind of non-physical harm and a few benefits. views, but no one proceeds from reasons measures to address some of these harms alone. Noticing that people can proceed (for instance, calls for making patentable • With few exceptions, in the United States from different ethical frameworks can help inventions open-source). But there has we have required policy makers to us better appreciate the disagreements been little meaningful engagement with consider concerns about physical harms, regarding whether the risks of physical and the second kind of non-physical harm, but expected them to remain largely silent non-physical harms are serious and what which depends on even more deeply regarding non-physical harms. Given actions should be taken in response to contested views about the appropriate role the ardency with which concerns about those risks. of humans in relation to themselves, other non-physical harms continue to bubble creatures and the environment. Some up in the public conversation about go so far as to argue that it is not worth emerging technologies, it is time to have a engaging with these concerns. systematic look at the question, what role can concerns about non-physical harms play in the policy world? We do not fully answer that question in this document, but take it to be central for our future research.

5 Who is doing what, where are they doing it and how is this current work funded?

Introduction It is difficult to find a hard-and-fast definition students. He also co-founded the gene of synthetic biology, given both the range of synthesis company Codon Devices. Codon Naturally occurring biological systems activities it involves and the frequent overlap Devices lists Flagship Ventures, Alloy Ventures, are even more complex and difficult to between synthetic biology and other fields of Khosla Ventures, Kleiner Perkins Caufield and 9 manipulate than anyone imagined 10 or research and technology. One way to begin to Byers and Highland Capital as investors. 20 years ago. There are myriad technical understand this range of activity is to look at the problems in getting these systems to act work of the field’s key players (indeed, the field Endy is working at what Maureen O’Malley the way we want. With synthetic biology, is still young enough so that we can identify et al. have called DNA-based device 7 however, scientists hope to leapfrog these four of the key players). These individuals come construction. He is spearheading an effort problems. One of synthetic biologists’ from different disciplines (including engineering to construct and catalogue a registry of what hopes is that by building biological and genetics), have different sources of he calls “biobricks,” which are made from systems from the ground up, they can funding, approach the topic from different DNA and other molecules and can in turn create biological systems that will function angles (creating biobricks out of DNA and be used by other researchers (on an open- like computers or factories, producing the other molecules, engineering whole genomes, source basis) to build what they want. 7 products we want, when we want and in creating cells) and have different goals (from the amounts we want.1,2 (Such industrial understanding the evolution of life to creating Endy’s catalogue of biobricks can be thought 8 analogies are inescapable when talking useful products like ethanol or artemisinin). of as bio-parts that, for example, will reliably n overview of the debates A n overview of about this work, and while they do not turn gene production on or off, or as bio-tools appropriately capture the “living” element Drew Endy, who left the Massachusetts that, for example, will reliably measure the of synthetic biology, they do exemplify the Institute of Technology (MIT) for Stanford concentration of a particular gene product. field’s central goal: to make biology easier University in 2008, is one of those key players. As Endy sometimes puts it, his parts will to engineer.1) Scientists also believe that Active not only in the scientific literature, be for the 21st century what screws and creating these products through synthetic Endy has been a leader in defining synthetic bolts were for the 19th, or what transistors 1 systems will be safer than merely trying to biology’s goals and engineering approaches. and resistors were for the twentieth. He manipulate naturally occurring systems to A civil engineer by trade, Endy founded the envisions that bio-industrialists will (for free), produce them.3-6 non-profit Biobricks Foundation and the download the genetic information they need to International Genetically Engineered Machines synthesize the genetic tool or part they need competition (iGEM) for undergraduate to manufacture a given project.1,10 ethical issues in synthetic biology: ethical issues in synthetic biology:

6 Craig Venter heads the J. Craig Venter which will include only the genetic material Institute (JCVI), which has two locations, needed to sustain the life of a bacterium.14 If one in Rockville, Maryland, and the other in successful, Venter could then insert the sort La Jolla, California. His institute’s website of bio-parts that Endy is working on into his describes JCVI as having more than 400 minimal genome, which could enable that scientists and staff and more than 250,000 genome to code for a new product such square feet of laboratory space. Synthetic as cheap biofuel. So far, Venter has shown biology (or what Venter sometimes calls that you can transplant a genome from one synthetic genomics) is one of the institute’s species of bacterium to another15 and that focus areas. The JCVI website does not you can synthesize a copy of a bacterial contain information about how this work is genome,16 but he has not yet been able to funded, but we have found references to take that synthesized copy and make it work funding from the Department of Energy and in a cell.17 Venter has applied for international National Institutes of Health (NIH), as well as patent rights on the minimal genome “the public” and “major foundations.” 11,12 The organism, dubbed Mycoplasma laboratorium, Department of Energy, the National Human JCVI also receives funding from Synthetic and hopes this will become the commercial Genome Research Institute, the Lipper Genomics, a private company founded by chassis for synthetic biology applications.18 Foundation and the National Cancer Institute. Venter in 2005. Synthetic Genomics reports Others, like Endy, advocate for a hybrid energy company British Petroleum and approach to intellectual property protection Church’s group is pursuing what O’Malley investment firms Biotechonomy, Draper whereby bio-parts and bio-tools are freely and her colleagues refer to as protocell Fisher Jurvetson, Desarrollo Consolidado de available and only specific applications are creation.7 Thus we can imagine that one of Negocios, Genting Berhad and Meteor Group patented.19;20 Venter’s modified, minimal genomes could as investors, along with its founders.13 be inserted into one of the synthetic cells George Church, at Harvard University, now being created by Church’s group at Venter and his staff are working at what is a molecular geneticist with a Ph.D. in Harvard.21 Such a synthetic cell could be O’Malley et al. have called genome-driven cell biochemistry and molecular biology. He viewed as a mini-factory, producing various engineering. For example, they hope to use has received funding from a number of substances, from treatments for devastating synthetic DNA to build a “minimal genome,” sources; his current funders appear to be the diseases to weapons of terror.

7 Jay Keasling, at University of California, Drew Endy would point out, what Keasling In addition to these key U.S.-based players Berkeley, is the fourth researcher most is doing is a significant step beyond the and other U.S.-based research groups, there frequently invoked in public conversations “cutting and pasting” of DNA done by is an international community of scientists about synthetic biology. The Keasling lab “traditional” genetic engineers;26 to some working on synthetic biology,29,30 as well as is funded by the Department of Energy, people, this step of transferring many a number of individuals and groups inside the Institute for One World Health, the Bill genes instead of one qualifies Keasling’s and outside the United States addressing & Melinda Gates Foundation, the NIH, the work as significantly different enough ethical, legal and policy issues. For example, National Science Foundation (NSF), the Jane to warrant a new label like “synthetic SYNBIOSAFE is a project supported by Coffin Childs Memorial Fund for Medical biology.”2,5 (We say more about the the European Commission and led by Research and the University of California, relationship between genetic engineering Markus Schmidt. It is “the first European Berkeley Davis Toxic Substances Research & and synthetic biology in just a moment.) project to research the safety and ethical Teaching Program.22 aspects of synthetic biology, and aims to Keasling, Endy and Church are all part proactively stimulate a debate on these Keasling’s lab has already engineered of the Synthetic Biology Engineering issues.”31 Schmidt is also the director of the bacteria to produce the anti-malarial Research Center (or SynBERC), which is Organization for International Dialogue and artemisinin, which some are calling the an NSF-funded, multi-institute effort “to Conflict Management, which contributes to “poster child” for synthetic biology.23 lay the foundation for synthetic biology.”27 the analysis, communication and management

n overview of the debates A n overview of (Keasling’s lab is working to scale up SynBERC does not aim only to turn of new bio- and energy technologies. production by 2010 through a partnership synthetic biology research into industrial SYNBIOSAFE held an “electronic conference” with the pharmaceutical company Sanofi- products and to train young scientists in spring 2008 with the stated goal to aventis.)24 They are also working to to become synthetic biologists. It also “stimulate a wider debate on the societal engineer bacteria to break down pesticides hosts a Human Practices Center, led by issues of synthetic biology in a proactive way.” and generate biofuels, among other goals. anthropologist Paul Rabinow and political Brief descriptions of ethical, safety, security Keasling’s work, however, resembles scientist Ken Oye, which does research and other societal issues were posted on an “traditional” genetic engineering more than on “evolving ethical practices in synthetic online discussion board, allowing participants the previous three examples, insofar as biology and emergent related fields (e.g., the opportunity to respond.32 he is essentially transferring a suite of at nanotechnology in NSF-funded centers).”28 least 14 genes into bacteria.25 However, as ethical issues in synthetic biology: ethical issues in synthetic biology:

8 How distinct is synthetic biology from other emerging areas of scientific and technological innovation?

Depending on the context, synthetic biology the 1970s was based on a central dogma Beyond the technical shortcomings, there is described either as radically new or that supposed that one discrete stretch of is a deeper conceptual problem with the comfortably familiar. Sometimes discussants DNA produces one discrete stretch of RNA old-fashioned approaches of the genetic stress the extent to which synthetic biology that produces one protein. That approach engineers. It turns out that the central has been going on for almost 40 years in allowed for some important successes, dogma was a significant simplification of the biotechnology, or even for millennia in human such as “biosynthetic” insulin, which is now terrifically complex processes out of which agriculture.33-35 At other times (including produced industrially by bacteria; the genetic most naturally occurring products emerge. when trying to attract investors or funders), “instructions” for human insulin are “pasted While there is skepticism that synthetic discussants emphasize how radically different into” bacterial genomes, and out comes biologists will successfully avoid those the technology is from existing approaches.36 badly needed medicine. complexities by “starting from scratch,”3,39 Simultaneous claims of novelty and familiarity that is indeed what some synthetic biologists can be difficult to process. As Jennifer However, many of the scientists who aim to achieve. Kuzma has noted in the nanotechnology pioneered these early methods readily context, “Developers should not tell the acknowledge its technical shortcomings: In contrast to the expensive methods of public that nanotechnology is unique and rDNA is expensive (parts and labor genetic engineering, commercial gene- thus will provide great benefits, and then turn accounting for $1.5 billion of the NIH synthesis companies are now able to around and tell them that a special regulatory budget),38 and, from an engineering manufacture virtually any DNA, built-to- look is not necessary.”37 Putting aside for a perspective, messy. Employing rDNA order. Users can simply type a particular moment the strategic benefits of a claim for requires a large technical knowledge base, sequence into an Internet order form and in newness or for familiarity, synthetic biology is, which can be difficult to translate to other a week or two the DNA arrives by mail.40 This altogether unsurprisingly, closely connected projects. Furthermore, there are some advance effectively “black boxes” the DNA- with existing lines of science and technology. genetic dishes that rDNA cannot directly manufacturing process by masking much cook up. For example, there is no wild-type of the complexity inherent in rDNA. More Synthetic biology and gene for a biofuel that can just be “cut and important, it is hoped that, in combination genetic engineering pasted”—or, as Endy sometimes says, with computer modeling, the building of de “bashed”—into a bacterium. Instead, a new novo proteins and the use of bioinformatics to The recombinant DNA (rDNA) technology, genetic dish must be created. predict and analyze those products, synthetic or “genetic engineering,” that grew up in biologists will be able to create systems that

9 are not only less messy or complex than chemists, physicists and engineers) is eyeing naturally occurring ones but also more efficient what the European Union terms in vitro “Recognizing the at producing the products we want. synthetic biology as a means of providing the “production facilities” for nanoscale interconnectedness Some have argued that “the involvement fabrication.41Already, nanoscientists are using of several new, non-biological scientific viruses to construct battery parts. As Angela of the science and engineering disciplines is what clearly Belcher at MIT recently said, “We’ve been distinguishes synthetic biology from getting really good in the last couple of years can also help us genetic engineering and ‘classical biology’” at using biology and biological mechanisms to (emphasis added).2 Others describe genetic grow and assemble materials and functional recognize the engineering as one of the tools of synthetic devices.”42 As we will suggest below, it is biology. We simply wish to observe that exceedingly difficult (if not impossible) to interconnectedness insofar as synthetic biology involves the distinguish between the ethical concerns that manipulation and transfer of genes, it is arise in the context of nanotechnology and of the ethical issues.” intimately related to genetic engineering. those that arise in the context of synthetic biology (or for that matter, genetic engineering). Synthetic biology and Recognizing the interconnectedness of n overview of the debates A n overview of nanotechnology the science can also help us recognize the interconnectedness of the ethical issues. Nanotechnology refers to the scale at which a heterogeneous set of activities takes place. Synthetic biology and While synthetic biologists may for strategic information technology reasons want to avoid the public attention that has surrounded nanotechnology, insofar DNA can, of course, be viewed simply as as synthetic biology occurs at the nanoscale, information. And, according to synthetic it would not be unreasonable to consider it biologists, cells can usefully be viewed as a form of nanotechnology. The large global networks much like the information networks nanotechnology community (dominated by in information technology. To take the ethical issues in synthetic biology: ethical issues in synthetic biology:

10 metaphor one step further, Endy and others information technology and synthetic biology one context than in another; some ethical envision a field where the information to be are so intimately interconnected that it might (or legal, or policy, or social) issues will found on these networks should be available not make sense to spend much time making be more difficult, more important or more for free to all responsible researchers, much neat distinctions among them—at least for the contested in one area of science or at one the way that some computer software is sake of thinking about the ethical questions. We time. Nevertheless, the core concerns, available for free (as “open source”).43 In should add that it is equally hard to cleanly and debate and values are familiar. In the best theory, anyone who wants to use the parts or consistently distinguish those just-mentioned of all possible worlds we would learn from tools derived by synthetic biologists should fields from other areas of scientific inquiry, such these previous debates and our previous be able to go to the shelf and use them for as cognitive neuroscience or even stem cell successes and failures at responding to free. Not incidentally, the convergence with research (some researchers have apparently them, so as to better anticipate concerns and information technology has large implications begun to use nanomaterials as the vehicles to address problems. Recognizing synthetic for where and how production of synthetic deliver genes to the nuclei of differentiated cells biology as another emerging technology parts and wholes can take place. Synthetic in an attempt to induce pluripotentiality).45 A few helps us avoid needlessly reinventing the biology builds on a decades-long trend years ago, this overlap and interconnectedness ethical wheel each time we encounter a in flexible manufacturing. As one recent moved Mihail Roco and William Sims “new” area of science.47;48 We acknowledge report explained, “DNA synthesis allows Bainbridge to begin speaking about the and understand that funders and grant ‘decoupling’ the design of engineered “convergence of emerging technologies.”46 writers might initially be tempted to describe genetic material from the actual construction the ethical issues surrounding synthetic of the material.”44 Once we place a genetic Viewing synthetic biology as an emerging biology as “new,” but in the long run such sequence in the global information network technology that is converging with many a strategy can lead to disappointment.47 A and combine it with remote and sophisticated others is not simply empirically accurate. It more prudent, if less dramatic, approach production technologies, regulation of can also help in a practical way: it can save makes clear from the beginning that even if synthetic biology becomes very challenging. us the resources it would take to search it makes sense to tackle the ethical issues for putatively new ethical questions. While as they arise with each field of science and “Emerging technologies” the basic ethical questions are very similar technology, these issues are familiar and have from one area of technology or science been considered, although not necessarily The overall point we are driving at is that to another, we do not dispute that some resolved, in other contexts in the past. genetic engineering, nanotechnology, ethical questions may be more pressing in

11 Ethics: What harms and benefits are associated with synthetic biology?

The field of ethics is about the many facets We surely do not mean to suggest that we engineering of biology” and “biological of the question, what ought we to do? In should give up the aspiration to give public property rights,” and featured a presentation the United States’ democratic tradition, we reasons. Rather, we are suggesting the need by anthropologist Paul Rabinow critiquing aspire to eschew answers to that question for realism about the nature of the arguments the process for identifying ethical issues that appeal to emotion or to any particular we offer each other, and that we bear in mind and questioning the validity of what is tradition’s understanding of God or nature. that none of us comes to the debates about sometimes called the concern about nature.51 Or, as it is sometimes put, we aspire to the ethics of synthetic biology from reason Substantially more information is available provide answers that appeal to public alone. Remembering this can help us respect about the second, third and fourth meetings reason alone. those with views different from our own. which can be streamed over the Internet (available at http://syntheticbiology.org/ As noble as that aspiration may be, the last The four researchers mentioned above (Endy, Conferences.html). century-and-a-half of social analysis and natural Venter, Church and Keasling), along with science has taught us the respects in which it many others, have come together in three One very important aspect of Synthetic is, if not naïve, then based on an incomplete conferences to discuss not only the science Biology 2.0 was a failed attempt to pass a description of how animals like us make of synthetic biology but also the ethical, legal, community resolution for self-governance arguments and arrive at conclusions.49 From social and policy issues that arise in the context that would describe “some principles for Darwin through to the experiments of today’s of that science. The first conference, “Synthetic advancing this new field in a safe and

n overview of the debates A n overview of neuroscientists, we now understand ever more Biology 1.0,” occurred in Cambridge, effective way”52 (see below for more detail). deeply just how intimately related reason and Massachusetts, in 2004. “Synthetic Biology Unlike the second meeting, which included emotion are. From Marx through to those same 2.0” happened in Berkeley, California, in 2006, no strongly critical voice, the third meeting neuroscientists, we understand how difficult and was billed explicitly as an international included a representative of ETC Group, it is to disentangle our own interests from the conference. “Synthetic Biology 3.0” occurred an Ottawa-based environmental advocacy “facts.” And from Durkheim through to Charles in Zurich in 2007, and “Synthetic Biology 4.0” organization, who noted that one invitation to Taylor,50 we understand that each of us brings took place in October 2008 in Hong Kong. a scientific conference did not amount to the residues from multiple intellectual traditions to kind of societal engagement they believe is each decision we make (even if one of them is The first conference, from which few necessary. The fourth meeting also included the tradition of atheism). materials are now available, included some critical voices and one session devoted discussion of “ethics related to the to a proposed consensus paper guiding the ethical issues in synthetic biology: ethical issues in synthetic biology:

12 development of synthetic biology, although it has been cited in support of claims that one proceeds from reason alone. Noticing no consensus document has yet emerged. synthetic biology in general, and Venter’s that reasonable people can proceed from work in particular, is ethical.7,17,54 More different ethical frameworks can help us Other meetings, as well as discussions, recently, several reports and articles, as well better appreciate the disagreements we will online conferences and publications, have as an e-conference, have addressed ethical observe about the existence of both physical begun to consider the ethics of synthetic issues raised by synthetic biology.2,32,55-57 and non-physical harms and about what, biology. One of the first, and for a long if anything, should be done in response to time one of the only, articles was written Below we aim to give a crude map of these harms or risks of harm. by a group of bioethics scholars brought the basic ethical concerns and ethical together in the late 1990s at Venter’s request frameworks that arose in these meetings, In the democratic tradition of the United to consider his specific goal of creating conferences and publications, and that States, one of the fundamental ethical a minimal genome organism. The group we, based on prior experience with other questions is, what are the relevant harms and considered the potential benefits to scientific emerging technologies, expect will arise in benefits associated with a proposed course knowledge and the practical applications the future. We will distinguish between two of action? Before saying something about of the minimal genome organism, the need sorts of ethical concerns: those that are first the different sorts of harms, we should say for monitoring of biosecurity risks and about physical harms, and then those that something about the potential benefits held potential intellectual property challenges. are first about non-physical harms. We also out by synthetic biology. Group members expressed a fear that the will distinguish between two sorts of ethical reductionist approach to life could “lead frameworks from which reasonable people Potential benefits science astray.”53 At the same time, they can proceed to the debates about both found no inherent objection by religious physical and non-physical harms: we will The benefits of pursuing synthetic biology groups to the research that Venter was suggest that when people are enthusiastic can be divided into two categories: proposing and argued that it did not violate about synthetic biology, they tend to use advancing basic knowledge and creating any existing fundamental moral precepts or the arguments at hand in the pro-actionary new products. Needless to say, the boundaries. This paper, now nearly a decade framework, and when critical they tend to use distinction between basic knowledge and old, did not purport to be a risk assessment, the arguments at hand in the pre-cautionary practical applications is hardly watertight. For a ruling or the final word on the ethical issues framework. People from each framework example, to get his commercial venture of raised by synthetic biology; nonetheless, can give reasons for their views, but no creating the minimal genome platform off the

13 ground, Venter and colleagues have to first suggested, the proof of the pudding may be To use an example that is closer to market, do the basic scientific work of determining in the making. Scientists like Benner hope Keasling’s work to engineer bacteria to what are the minimal requirements for life. that synthetic biology will allow for biological produce artemisinic acid is notable not Nonetheless, it is a distinction often used in hypotheses to be tested more rigorously.58 because this is a novel drug we do not know these discussions and has been described as how to acquire; it is a naturally occurring a “central tension in synthetic biology.”7 Creating useful applications product of the sweet wormwood herb. A second sort of benefit of synthetic The problem, as Keasling sees it, is that Advancing knowledge biology would come in the form of practical the plant takes too many months to grow, and understanding applications, such as the creation of new and harvest yields are simply too small to One goal of synthetic biology is to better energy sources, new biodegradable plastics, meet the global need for effective malaria answer basic questions about the natural new tools to clean-up environments, new combination treatments. Even at around world and to elucidate complex biological ways of manufacturing medicines and new $2.40 per treatment, the parts of the world processes—about how DNA, cells, weapons.8 It is hoped not only that these that need multi-course antimalarials most organisms and biological systems function. applications will create products that are are least able to afford them.65 By combining How did life begin? How does a collection completely new but also that their production genes and molecular pathways from the of chemicals become animated life? And, will be cleaner, faster and cheaper than we wormwood plant, bacteria and yeast into a of course, what is life? Synthetic biologists can currently achieve.59-61 bacterial “chassis,” Keasling trusts that the

n overview of the debates A n overview of take to heart the last words that the physicist medication’s cost can be driven down to Richard Feynman putatively wrote on his Perhaps precisely because many of the pennies; his teams have already increased chalkboard: “What I cannot create I do not objections to “re-engineering nature” synthetic artemisinin output 10-million-fold understand.”26 may stem from concerns about the since the first experiments in 1999.66 Here the environment, scientists and funders economic benefits of synthetic biology have One of the hopes is that, by engineering or interacting with the press have particularly the potential to have a positive impact on reengineering living organisms in the lab, stressed the potential “green” synthetic public health. synthetic biologists will be able to understand biology applications: from biofuels62 how the biological world works in areas to carbon sequestration,8 from oil spill Many scientists see Keasling’s work as where earlier analytical approaches fell short. remediation63 to arsenic-sensing bacteria.64 only the beginning. Projects such as Endy’s As the molecular biologist Steven Benner has Biobricks Foundation and Venter’s biological ethical issues in synthetic biology: ethical issues in synthetic biology:

14 specimens circumnavigation are creating Board Task Force on Military Applications Some discussion of physical harms massive genetic sequence repositories of Synthetic Biology is studying possible distinguishes between known harms (for that will make it possible to avoid starting ways to apply synthetic biology to military example, we know that the synthetically from square one with each new project. technology.68 De novo protein engineering engineered smallpox virus could be fatal Researchers associated with these projects could allow for the creation of wholly new to anyone exposed), unknown harms (for are working to describe existing, and to gene products, for which no known natural example, although we know that bacteria create new, bio-parts and bio-tools so that template exists.69 Instead of searching for a and viruses mutate rather quickly, we do the next pharmaceutical does not take many vaccine from known compounds, scientists not know how a synthetically engineered tens of millions of dollars and hundreds hope to be able to design new targeted virus or bacterium will mutate) and unknown of person-years of effort to produce. The cures.8 Proponents of human enhancement unknowns (that is, harms that, given the iGEM competition for undergraduates was technologies such as Gregory Stock have current state of our knowledge, we cannot founded to show that it does not take a written excitedly on the prospect of creating yet anticipate). doctoral degree to design a biotechnology artificial chromosomes containing genes that product. Much of the economic promise of would dramatically augment human traits—or Insofar as security measures aim to promote synthetic biology rests in its rational approach create wholly new ones.70 our safety and protect us from physical to biological design, which could reduce harms, concerns about security and safety research and development time. Potential harms fall squarely under this rubric of physical harm. Insofar as discussions about the Other efforts go beyond the “biofactory” In addition to describing benefits such as rights and responsibilities of researchers models, which have been the bread and those just mentioned, the literature cites and appropriate governance mechanisms butter for the biotechnology industry since a number of potential harms surrounding are ultimately about how to protect us from the development of biosynthetic drugs like synthetic biology. Some of those concerns physical harms, those discussions also fall insulin. Engineers at SynBERC, for example, are about potential physical harms, such as under this rubric. There is often debate about are working to engineer a tumor-destroying those that might be done to the health of whether a proposed means to respond to bacterium.67 Other groups, including the persons or the environment if a synthesized risk of physical harm is ethical. Defense Advanced Research Project Agency, molecule or organism mutated or escaped have funded early projects to develop and contaminated someone or something For instance, one mechanism for dealing biological computers.26 The Defense Science outside of the controlled research setting.20,23 with security concerns, secrecy, has been

15 called both ethically necessary and unethical. offense—that making the knowledge widely access to inventions and for whose gain) and Bill Joy and Ray Kurzweil have argued that available will enable the development of others that rest on views about the ­ some knowledge learned from synthetic antidotes and other strategies for managing (in)appropriateness of owning patents on biology should be kept secret (some scientific dangerous substances.75 Others argue that, living organisms. Both kinds of concern about findings should be censored), such as the as a matter of principle, secrecy is unethical. patents on synthetic biology inventions would findings regarding the sequence of the fall under our rubric of non-physical harms, genome of the 1918 flu virus, to protect It is perfectly reasonable that the risk of even though they are grounded in different people and the environment from the risk physical harms (threats to safety and security) fundamental concerns. Additionally, insofar of physical harm.71 Michael Selgelid also has been a central topic of discussion at the as synthetic biology raises concerns about argues that with synthetic biology we may international SynBio meetings and among the distribution of risks and benefits, which have to compromise our commitment to ethicists speaking about these issues in also rest on deeply held but contested views transparency to promote our security.72 general.76-82 But as we mentioned above, of fairness and equality, those concerns also many ethical concerns are about the risk of fall under our rubric of non-physical harms. Following publication of the papers that non-physical harms, or alternatively, what And concerns about the prospect of using described how to synthesize the mousepox we might call harms to the well-being of these technologies to enhance human traits and polio genomes, concern grew about the individuals or communities. Concerns about and capacities return us to an ongoing debate risk of physical harm following publication.73 non-physical harms focus on the possibility about our appropriate relationship to our

n overview of the debates A n overview of In 2004 the federal government created of harm to deeply held (if sometimes hard-to- bodies. The concern that humans might be the National Science Advisory Board for articulate) views about what is right or good, overreaching when we create organisms that Biosecurity (NSABB). One of the issues on including conceptions of fairness, equality, never before existed can be a safety concern, which the NSABB advises researchers and progress and the appropriate relationship of but it also returns us to disagreements about the government is the communication of humans to themselves and the natural world. what is our proper role in the natural world (a the results of what the Board calls “dual-use debate largely about non-physical harms or research of concern.”73 Critics of the secrecy For instance, among the many concerns harms to well-being). approach call it unrealistic and impractical, about the patenting and commercialization arguing that we simply will not be able to of advances in synthetic biology are some One way to respond to the risk of these keep the knowledge secret.38,44,74 Some that rest on deeply held but contested views and other non-physical harms is through argue that the best defense is a strong about fairness (who should control and have regulation or oversight. While most ethical issues in synthetic biology: ethical issues in synthetic biology:

16 regulation or oversight seeks to address goal. That is, we can agree that physical the risk of physical harm, it could also harm is undesirable. There is significant “It is crucial to seek to address non-physical harms, disagreement, however, about how we although it seldom does. In United States’ should do so, who should be responsible recognize that, as governance of emerging technologies, non- for setting standards or determining safety, physical harms have received little policy who should bear the burden or risk or how with physical harms, attention, with a few small exceptions; for much society should spend on reducing example, the Recombinant DNA Advisory risks to humans and the environment. In we disagree about Committee advises the NIH director on the environmental context, there is even “scientific, ethical and legal issues raised disagreement about whether a particular non-physical harms by recombinant DNA technology and its outcome amounts to harm. basic and clinical research applications” because we adopt and in this capacity has considered issues There is also some, although often not as such as the equitable distribution of rDNA much, agreement that preventing or reducing different ethical technologies;83 and the recent Genetic non-physical harms is an important social Information Non-Discrimination Act,84 which goal. That is, we have some agreement at protects Americans from discrimination the level of core values that human flourishing frameworks.” based on genetic information in the contexts is good; we should work to preserve equality, of health insurance and employment. The promote prosperity and uphold shared moral National Bioethics Advisory Council and values. But compared with physical harms, or about how best to understand fairness, the President’s Council on Bioethics have there is significantly more disagreement equality and our appropriate attitude toward taken up non-physical harms, but purely in about whether a particular activity threatens nature. It is crucial to recognize that, as with an advisory capacity—they were not able to these values, how we should reduce non- physical harms, we disagree about non- make policy. physical harm, who should be responsible physical harms because we adopt different and what may be sacrificed along the ethical frameworks. In fact, we suggest here There is a straightforward sense in which way. We do not always agree about what that the roots of the disagreements about we can all agree that preventing or reducing counts as a non-physical harm, because we physical and non-physical harms are often physical harms is a very important social disagree about what is human well-being, intimately related, if not the same.

17 The pro-actionary and pre-cautionary frameworks

As we just mentioned, we can all agree approach.85 The basic idea is that emerging fear another version of the embryonic stem that the aim of preventing physical harms is science and technology should be considered cell troubles in the United States, where good—that we ought to seek to prevent or safe, economically desirable and intrinsically they believe that funding restrictions harmed ameliorate negative environmental impacts, good unless and until it is shown to be American competitiveness and stymied contamination of naturally occurring genomes otherwise, which means that the burden of scientific progress.91 On this sort of pro- and the creation of deadly pathogens for proof is on those who want to slow down a actionary view, one of the biggest “risks” the purpose of bioterror.20 Different people, given line of research. Those who emphasize facing our nation is that the technology will however, hold different views about which the pro-actionary attitude can appeal to not go forward quickly enough and that the values we should emphasize (or give fundamental ethical commitments to defend American public, American industry and the priority to) in preventing physical harms their framework, including commitments to the American economy will miss out on crucially and promoting safety. They will therefore freedom of researchers and business people important opportunities for growth and hold different views about how to prevent to pursue their work,72,86,,87 economic growth,8 improvement. physical harm and about what is and is not American competitiveness,75 and human acceptable to sacrifice along the way. To health and well-being.88,89 These appeals The pro-actionary framework shapes not begin to get at the difference between these are especially powerful when the promised only how enthusiasts define and weigh views, we will (somewhat crudely) distinguish benefits of a particular line of scientific or the risks and benefits of synthetic biology between what we will call the “critics” and technological enquiry include clean water, but also what they think should be done

n overview of the debates A n overview of the “enthusiasts.” (Our distinction is largely cheap food and cures for terrible diseases. in response to these risks and benefits. the same as Nikola Biller-Adorno’s distinction Two main activities—governance and between “the concerned” and “the cool.”76) As hopeful as enthusiasts are about the public engagement—are often discussed We understand that most people will find potential for synthetic biology to do good, in response to emerging technologies,92-95 themselves somewhere between these two they are fearful about the prospect of the although the different frameworks have views or will fluctuate in their view depending United States succumbing to what they different understandings of what exactly on the particular facts under consideration. take to be the huge European mistake in these activities would amount to. When the context of genetically modified foods.90 enthusiasts call for “public engagement,” Enthusiasts about emerging science and They fear that public skepticism could they often mean educational activities aimed technology tend to approach synthetic biology hinder uptake of consumer products and at getting the public on board so that the with what might be called a pro-actionary ultimately slow down the science.8 And they benefits of the research are not diminished, ethical issues in synthetic biology: ethical issues in synthetic biology:

18 as they arguably were in the context of Some self-regulatory approaches can also be which option or options should be pursued, genetically modified foods. As Richard found in the Sloan Foundation–funded report, and although some of the options certainly Jones, in the nanotechnology context, has Synthetic Genomics: Options for Governance. amounted to more than simple self-regulation, (critically) suggested, “public education” can Focusing on a particular set of risks (the the options are, on their face at least, far less be interpreted as a way to diffuse opposition, possibilities of bioterrorism, harm to laboratory restrictive than those sometimes proposed by a ‘fig leaf’ of public consent.”96 workers and harm to communities near more critical groups and individuals, such as laboratories), the project behind the report bans on certain experiments or governance, Unsurprisingly, a pro-actionary attitude brought together individuals with a variety of including boundary setting, through a kind of tends to correspond to a preference for policy, legal, scientific, ethical, business and intensive public engagement.23 minimal governance, usually in the form social science expertise to identify areas for of “self-regulation.”92, 97,98 For example, possible policy interventions and specific Some advocates for self-regulation invoke the Stephen Maurer and Laurie Zoloth argue in options for such interventions. The report was 1975 Asilomar Conference on Recombinant Bulletin of the Atomic Scientists that self- written by Drew Endy of MIT; two members DNA (rDNA) as a shining example of regulation is the only practical way to control of the J. Craig Venter Institute’s Policy scientists regulating themselves. Embroiled in the security risks posed by synthetic biology. Center, Michele S. Garfinkel and Robert M. controversies that rival the current synthetic “In this environment,” they say, “initiatives Friedman; and Gerald L. Epstein, who works biology debates, the 140 scientists at developed by the synthetic biology at the Center for Strategic and International Asilomar sought to find a path to continue community may be more effective than Studies. It compared 13 governance options. rDNA work, outline the potential risks of government regulation precisely because In addition to self-governance approaches creating transgenic organisms and end the they are more likely to be respected and (such as education or use of a clearinghouse voluntary moratorium on rDNA experiments taken seriously. From a policy standpoint, for scientists to share information), a number called for by molecular biologists in 1974, too, building a nongovernmental body for of options that have an implied regulatory who expressed “serious concern that some implementing biosecurity policy seems like component (such as requiring commercial of [the] artificial recombinant DNA molecules a good investment.” They conclude that DNA synthesis firms to use approved could prove biologically hazardous.”99 After a “protecting the public from the risks of screening software and to store sequence three-day discussion of the safety risks (the synthetic biology depends on the scientific data from orders for potential forensic uses) concerns we call the non-physical harms community’s will, capacity, and commitment were included. Although the report did not were deliberately left off the agenda100), the to regulate itself.” make any specific recommendations as to scientists at Asilomar agreed that it would

19 be safe to proceed under a set of laboratory The same Nature editorial, published in 2004, open letter signed by the ETC Group and guidelines. Experiments with known minimal when the debates about synthetic biology other civil society organizations protesting risk would require only basic containment were just ramping up, argued that public their exclusion from the debate,104 internal measures, such as wearing a lab coat. Work trust in synthetic biology might be “won” by disagreements among the scientists at the deemed riskier—such as experiments with following the Asilomar model.102 In effect, the meeting about whether the resolution was animal viruses—would require greater safety second Synthetic Biology meeting (Synbio the next logical step (some proposed, for measures, including using bacterial hosts 2.0) attempted to do this: a resolution was example, that a professional organization unable to survive outside of the laboratory. proposed to begin instituting a system of should be established before self-regulation Finally, experimentation on highly pathogenic self-regulation in response to the concerns is undertaken) and, apparently, the fact that organisms and “toxic genes” was determined about physical harms. The resolution grew it was tabled at the end of the meeting when to be too dangerous for current containment out of the Berkeley SynBio Policy Group, many participants had left or were simply too strategies.101 These recommendations a joint project of Keasling’s lab and the tired to tackle the issue.93 The resolution has formed the basis of the 1976 NIH Guidelines University of California, Berkeley’s Goldman not been resurrected at subsequent synthetic for Research Involving Recombinant DNA School of Public Policy and funded by the biology meetings. Molecules, which were used by NIH’s Carnegie and MacArthur Foundations.92 Recombinant DNA Advisory Committee After interviewing several scientists working Critics tend to be skeptical about the wisdom (RAC) to oversee gene-transfer research. in synthetic biology and holding a series of of relying on self-regulation. Mockingly,

n overview of the debates A n overview of “town meetings,” the group concluded that they characterize it as, “Trust us, we’re the Although the Asilomar conference led to self-regulation ought to be the main response experts.”23 They tend to adopt instead a pre- guidelines used by an NIH committee, it is to developments in synthetic biology. The cautionary attitude, which suggests that new largely considered a success story for self- resolution tabled at Synbio 2.0 proposed substances should be considered dangerous regulation, primarily because the conference screening synthetic DNA orders, articulated until shown to be safe and that new brought a swift end to the moratorium and a commitment to addressing the “challenges technologies should be considered potentially headed off more restrictive regulatory action. to biological security and biological justice” threatening to ways of life and systems of But perhaps most important, as a Nature and, perhaps most contentiously, singled meaning. Under a pre-cautionary approach, editorial suggests, there was no “biological out self-governance alone among possible the burden of proof lies on those who might Chernobyl.”102 policy responses.103 The resolution was put the environment or public safety at risk or not passed for a number of reasons: an who might disrupt ways of living or systems ethical issues in synthetic biology: ethical issues in synthetic biology:

20 of meaning,89 which usually results in calls for commercial products are introduced and “The goal is to more governance and public engagement more independent, third-party assessments and for a slower pace of research and of risks and benefits.105 None of these avoid repeating the development. options has yet been embraced by the synthetic biology enthusiasts. mistakes of the past, Critics of self-regulation point out that although members of the synthetic Like those comfortable with a pro-actionary where technologies biology community seem to be aware attitude, those who emphasize the pre- of and concerned by the potential for cautionary attitude invoke fundamental like asbestos, public backlash (they fear a reprise of ethical commitments, including the the controversy over genetically modified importance of protecting the environment chlorofluorocarbons, organisms), they have not yet paid much from our well-intended mistakes and of attention to the lessons from earlier and safeguarding the public from the ill intentions DDT and thalidomide ongoing social science research. For of terrorists. On the view of the critics, one instance, focus groups commissioned by of the biggest “risks” is that science and the Woodrow Wilson Center’s Project on technology will move forward too quickly, were developed Emerging Nanotechnologies found no public and there will be no chance to say no or support for self-regulation of nanotechnology to shape its development so that it serves before their risks had (nor, interestingly, for a moratorium on the interests of all people and not simply nanotechnology research). After receiving the interests of scientists, investors or been adequately balanced scientific information, a majority of big business. While the ETC group has people in structured focus groups converged in fact advocated a ban on the release assessed…” around three strategies to address the of de novo synthetic organisms,23 most question “How can government and industry of the advocates for precaution suggest increase public trust around emerging an important role for a variety of forms of technologies?” They recommended more governance. They therefore call for external transparency and disclosure by industry regulation of emerging technologies20 and and government, pre-market testing before for public engagement, in addition to self-

21 regulation. According to Jones, who is O’Malley et al. argue that as biologists While we do not agree that ELSI or bioethics speaking about nanotechnology, critics tend and engineers become ever more aware research has wholly failed to engage with to suggest methods such as consensus of the complexity of biological systems— science and technology upstream—indeed, conferences, focus groups and citizen juries and become ever more keenly aware upstream engagement was one goal of that both engage the public and govern the of the deficiencies of the old-fashioned, NIH funded ELSI research—the goal as technology, although additional governance simplistic, linear view that was expressed described by O’Malley et al. is important in the form of government regulation is also in the central dogma of genetics—we will and reasonable. Experience has shown, often embraced.96 move away from a model of downstream however, that it can be difficult to achieve, ethical, legal, and social implications in part because the further upstream one When advocates of the pre-cautionary (ELSI) research to a new “socioethics.” goes the farther one moves away from attitude call for “public engagement,” As O’Malley and her colleagues put it, concrete applications and other activities they tend to mean allowing citizens to “A more valuable socioethical approach that will have a direct impact on individuals offer an upstream critique of science and to systems biology would study systems and communities. Nevertheless, upstream technology.106 The goal is to avoid repeating biology as it develops, rather than waiting engagement could influence research the mistakes of the past, where technologies until the science has already set its course priorities, provide critical feedback on like asbestos, chlorofluorocarbons, DDT and … [and, by engaging with scientists would] hypothetical future applications and, perhaps thalidomide were developed before their anticipate (and to some extent shape) the most important, be used to establish and test

n overview of the debates A n overview of risks had been adequately assessed, and emerging social issues.”39 In so doing, processes and mechanisms that will respond where technologies like genetically modified René Von Schomberg suggests that to or deal with issues as they arise. On this foods were brought to market before both because the effects of individual actions in understanding, public engagement becomes their impact on human and environmental the realm of emerging technologies could a kind of governance. health and their impact on traditional farming potentially have such far-reaching systemic practices and other well-being concerns and social effects, we need a “transformed had been carefully—and democratically— notion of responsibility” that goes beyond addressed.39 This kind of public engagement the focus on individuals to a focus on will likely slow scientific and technological “social institutional spheres.”107 progress, but proponents believe that this price is worth paying. ethical issues in synthetic biology: ethical issues in synthetic biology:

22 Competing—and potentially complementary—views about non-physical harms (harms to well-being)

While we have just discussed how come to agreement about conceptions of cell debate in light of the breadth of the enthusiasts and critics can hold very different well-being, which draw on “incommensurate Thomson patents)109 and about invasions views about how best to promote their discourses” that include a large religious of privacy and discrimination (prominent shared aim of preventing physical harms, the element. Zoloth argues that we cannot “solve in the nanotechnology and genetic-testing debate about non-physical harms is still more these issues, even by logical argument.” debates). These concerns, while not complicated. That is because whereas we In the face of such deep disagreement, universally shared, have achieved some have something of a consensus about what bioethics can only invoke what she calls traction among researchers and scholars due physical harms are and that they should be “the ELSI liturgy” of “public discourse, to their foundation in shared (if contested) avoided if possible, we do not have a similar open access, transparency, training, public notions of privacy, equality and fairness. consensus about what non-physical harms education, collaboration, international codes, are or under what circumstances they should oversight, be careful, weapons are generally Further, while in past debates about be avoided. This lack of consensus can lead evil, and excessive profits are unfair.”77 emerging technologies we have thus far to despair: some would say that because our failed to get very far in our discussion of understanding of what a non-physical harm While we understand some of the frustration some of the other well-being concerns—such is will always rest on a particular conception expressed by Endy and Zoloth, we believe as concerns about human enhancement of what well-being is, and because well-being that it is a conceptual and practical mistake (prominent in debates over reprogenetics will always be contestable, we ought not to try to bracket discussion of competing and neuroscience) and about altering living waste our time discussing it. conceptions of well-being—at least at this creatures or creating new kinds of living stage of the public conversation. For one creatures (see the debates over germ-line Talking about the oft-expressed concern that thing, we have come some way in discussing gene therapy and creation of animal-human humans are overreaching in their attempts some particular well-being concerns and chimeras)—we do not think we should give to create life from scratch, Drew Endy can draw on those lessons in the context up on these concerns. asserted, “The questions of playing God or of synthetic biology. For example, we have not are so superficial and embarrassingly developed a language for identifying and If Zoloth meant that invoking the ELSI simple that they’re not going to be useful in addressing concerns about the impact liturgy provides a way to circumvent a discussion.”108 Or, as Laurie Zoloth suggested of patenting and licensing practices on discussion of incommensurable values, at the Synthetic Biology 3.0 meeting, it would the development of new technologies (a then we believe she is making a conceptual be unprofitable to spend our time trying to concern prominent in the embryonic stem mistake—at least insofar as she does not

23 “…although members of the synthetic biology community seem to be aware of and concerned by the potential for public backlash (they fear a reprise of the controversy over genetically modified organisms), they have not yet paid much attention to the lessons from earlier and ongoing social science research.”

seem to acknowledge the extent to which When we give up on the difficult well-being Trying to bracket the harder well-being our interpretations of the values enshrined in concerns, we tend to subconsciously questions is also a practical mistake. the ELSI liturgy will themselves depend on or reflexively privilege the pro-actionary Because people are worried about the the particular ethical frameworks from which framework, which so prominently excesses of the pro-actionary attitude and

n overview of the debates A n overview of we proceed to the debate. For example, emphasizes the goodness of control and are eager to investigate their pre-cautionary people who proceed from the pro-actionary productivity. Those values are important, intuitions, ignoring their firmly held intuitions and pre-cautionary frameworks will interpret but their centrality is particular to the pro- risks alienating many well-intentioned people terms like “public discourse” and “public actionary framework. To someone who from the conversation. education” and “unfair” differently because operates comfortably out of that framework, they proceed from different ethical values it can come to look like no framework at and premises. It is, we believe, a mistake to all—it can come to look like just a reflection fail to appreciate the extent to which those of the way things are. But, again, failing to differences in interpretation of the ELSI liturgy see one’s own particular ethical framework reflect differing conceptions of well-being. as a particular ethical framework is a conceptual mistake. ethical issues in synthetic biology: ethical issues in synthetic biology:

24 The most contested harms to well-being

Trying to engage those intuitions about this plentiful food and clean drinking water. If we respect for higher forms of life.”55 That is, if we second class of non-physical harms and observed such a deep respect for nature continue down this road, we risk undermining about the conceptions of well-being that they that we failed to change ourselves and our our respect for animals and, ultimately, humans depend on, however, is difficult. Whereas environment, we would remain victims of as they naturally occur. They also argue that we have a fairly well-developed public disease and slaves to our most basic needs; when creatures like us adopt the attitude of language to discuss physical harms, and an we would miss out on progress. creators, we are making a category mistake—a emerging language to talk about economic mistake about the sorts of beings we really are. harms, invasions of privacy, discrimination Critics often feel some level of unease with Less self-conscious, nonacademic authors and injustices (the first sort of non-physical this attitude toward the natural world. While would have used an unfashionable phrase harms), we still lack one to discuss concerns they might not be absolutists and therefore about “playing God” to describe this mistake. about creating new kinds of life or altering might agree that we should seek to fight While there are good reasons for rejecting naturally occurring organisms, despite our disease and seek out new ways to produce language referring to God, we believe (as did experience with genetics, stem cell research, food and fuel, they say that we should also Cho et al. in a much earlier piece in Science53) nanotechnology and neuroscience, among look at the “deeper ethical issues.”2 One that we should not ignore a concern that other areas. The appropriate attitude that problem for the critics, however, is that they continues to be widely shared. humans ought to hold toward the natural lack a fully adequate language for articulating world, including the extent to which we want these deeper ethical issues. This difficulty to remake ourselves and the world around is apparent in an article by Joachim Boldt us, is a familiar concern, but we have not and Oliver Müller in a recent issue of Nature made much progress in exploring it. Biotechnology, which is thus far the most ambitious attempt to articulate these “nature” For enthusiasts, the appropriate relationship concerns in the synthetic biology literature. of humans to nature is that of artists to their clay: we should see the natural world Boldt and Müller argue that if we begin to (including ourselves and our offspring) as create lower forms of life and to think of them ours to mold and modify as we want.110 as “artifacts” (as researchers in synthetic If we did not take that view, argue the biology propose), then we “may in the (very) enthusiasts, we would lack antibiotics, long run lead to a weakening of society’s

25 Conclusion: Moving the debate forward

A variety of potential harms are being self-regulation rather than formal regulation critics and enthusiasts, finding themselves identified with synthetic biology. One way through a federal agency. Alongside self- torn between the insights of each side. to carve up these potential harms is to regulation, some enthusiasts also advocate distinguish between what we call “physical the use of public funds for the kind of On the question of non-physical harms, harms” and “non-physical harms.” These public engagement that seeks primarily or we observed some agreement among potential harms are not unique to synthetic solely to educate the public about risks and enthusiasts and critics that some non- biology—they are familiar concerns that have benefits so that members of the public can physical harms are worth discussing, and been raised (and sometimes realized) in the become informed consumers of emerging possibly even addressing. While there is context of other emerging technologies such technologies. surely more work to do in conceptualizing, as genetics, neuroscience, stem cell research identifying and addressing these non-physical and nanotechnology. In the literature, we Critics (those who are concerned about harms, there is already some acceptance, for observed fairly consistent agreement about advances in synthetic biology) tend to example, of the legitimacy of the concern that what might be the potential physical harms adopt a pre-cautionary view, arguing that patents might slow down research and of of synthetic biology, although there is we should be prepared to interfere with the voluntary open-source practices as one way disagreement about how likely those harms development of an emerging technology to address this concern (although there is not are to eventuate and about what action, if if we have good cause to suspect that it agreement about whether voluntary action is any and at what cost, should be taken in might cause serious physical harm, and they the best or only way to ensure the availability

n overview of the debates A n overview of order to prevent or remediate them. generally see such a risk in synthetic biology. for further research of useful inventions). Critics advocate for regulation, oversight Enthusiasts (those who are generally positive (usually external oversight) and the kind of However, there are non-physical harms about advances in synthetic biology) tend to public engagement that actually shapes the that have thus far received short shrift in adopt a pro-actionary approach to the risk development of emerging technologies, such discussion of synthetic biology. There is very of physical harm, arguing that we should as is practiced in some European countries little agreement about the precise nature or not seek to interfere with the development around genetically modified foods and legitimacy of these concerns, let alone what, of an emerging technology unless we have other emerging technologies and is being if anything, might be done to address them. very good cause to suspect that it will employed and studied in the United States This group of non-physical harms centers cause serious physical harm. And if we do around nanotechnology.111-115 Many people around concerns about the appropriate interfere, many enthusiasts advocate minimal fall somewhere on the spectrum between relationship between humans and nature and ethical issues in synthetic biology: ethical issues in synthetic biology:

26 about whether humans ought to intentionally funders should undertake a coordinated Act and various air, water, solid waste, worker create new kinds of life. research and outreach program that includes safety and consumer protection statutes. funding for conceptual and empirical research. As with nanotechnology, some research We suggest that those who fund and lead will likely be required to identify any gaps or synthetic biology seek to respectfully and It will also be important, when examining mismatches in existing regulation as it applies carefully describe, and critically evaluate, concerns about physical and non-physical to synthetic biology.116 concerns about both physical and non- harms, to seek to respectfully and carefully physical harms. In so doing, they should describe, and critically evaluate, the various In the realm of non-physical harms, we draw on our experience of these concerns in understandings of these concerns and can point to the reasonableness of NIH’s the context of other emerging technologies, suggested responses to them that are recommendations and guidelines regarding including genetics, neuroscience and formulated from within both the pro-actionary the patenting and licensing of research nanotechnology. How were these concerns and pre-cautionary frameworks. tools and genetic inventions117,118 and some conceptualized, what values were appealed progress in accepting and understanding to in their description, how were the concerns In the realm of physical harms due to concerns about inequitable access to new addressed and what lessons can be critically bioterrorism, we can already point to the technologies. But there is still a long way to applied to the case of synthetic biology? In reasonableness of the National Research go in understanding and addressing what we some cases, these familiar concerns were Council’s Committee on Research Standards call here the second class of non-physical better articulated and understood following and Practices to Prevent the Destructive Ability harms. There is a tendency, in fact, to ignore funding of conceptual and empirical research of Biotechnology, which seems to be headed these concerns or dismiss them as irrational on the ethical, legal and social implications of for a hybrid approach that seeks to promote or of relevance only to people subscribing to the science or technology in question. In all insights from both frameworks: they suggest a particular religion. As an empirical matter, cases, individuals from outside the scientific ways to promote scientific and economic this is false: many critics concerned about community, including scholars and activists, freedom while also protecting humans and this second class of non-physical harms are were given a seat at the table, bringing their the environment from security threats.87 As rational and profess no religion at all. values, conceptual frameworks and suggested synthetic biology moves out of the laboratory responses to the discussion. To adequately and is scaled up, existing regulations will likely Dismissal is premature. Instead, we need to describe and address the risk of physical be triggered, including the Toxic Substances begin to hybridize the strengths to be found and non-physical harms, federal and private Control Act, the Community Right-To-Know in the pro-actionary and pre-cautionary

27 “By better understanding precisely what values are considered at play in the context of synthetic biology, we will be in a better position to understand what action would be reasonable to expect or recommend.”

frameworks so as to better understand those questions are worth taking seriously. world, we can hope to better understand each what critics are concerned about and By better understanding precisely what other. When we listen carefully and respectfully what enthusiasts celebrate in synthetic values are considered at play in the context to the concerns of others, we live up to a widely biology. Through empirical and conceptual of synthetic biology, we will be in a better shared normative commitment to respect one research, we need to better understand what position to understand what action would another. We also allow for the possibility of individuals in our society mean when they be reasonable to expect or recommend. As some change, however slight, in our views and cite a concern that some synthetic biology is with other harms, we should draw on our our practices. Understanding and respect can against nature or is playing God. For those experience of these concerns in the context affect the selection of experiments and eventual who believe that the job of human beings is of other emerging technologies, including products, the communication of results and

n overview of the debates A n overview of to actively shape themselves and the rest genetics, neuroscience and nanotechnology. the direction of publicly funded programs. of the natural world, synthetic biology is It can also make more receptive those who an obvious next step, and concerns about We are confident that we can achieve some might initially have opposed synthetic biology. “playing God” are incoherent. While powerful, clarity about what specifically is feared will The costs of this enhanced understanding are that understanding of our place in the world happen if humans become creators of new life money—the research and outreach must be is but one very particular understanding. forms—that is, about what we might lose when funded—and time—the progress of science For those who believe that the job of human we “play God”—and we can begin to debate might be slowed to keep pace with research beings is to accept and “let be” some whether there are reasonable ways to address and engagement. Experience with other features of themselves and the rest of the these fears. While we are unlikely to definitively emerging technologies strongly suggests that natural world—and for the many of us who answer the questions concerning the wisdom this would be time and money well spent. oscillate between these two intuitions110— of shaping ourselves and the rest of the natural ethical issues in synthetic biology: ethical issues in synthetic biology:

28 References

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ethical issues in synthetic biology: ethical issues in synthetic biology: Democratic Decision-Making,” Science and Public Policy 26, no. 331 (1999): 340.

32 WOODROW WILSON Erik Parens is Senior Research Scholar at the Hastings Center, a bioethics research institute in International Garrison, New York. He received his B.A., M.A. and Ph.D. degrees from interdisciplinary programs in CENTER for scholars the humanities at the University of Chicago. Since arriving at the Hastings Center in 1992, he has led a variety of research projects that explore how we use new science and technology to shape our selves.

Lee H. Hamilton Josephine Johnston is Research Scholar and Director of Research Operations at the Hastings President and Director Center. A New Zealand–trained lawyer, Ms. Johnston holds a master’s degree in bioethics and health law from the University of Otago, New Zealand. She works on a range of ethical, legal and policy BOARD OF TRUSTEES issues in biomedical research and medicine. Joseph B. Gildenhorn Chair Jacob Moses is Research Assistant at the Hastings Center. He graduated from Vassar College with Sander R. Gerber Vice Chair honors in science, technology and society.

Public Members James H. Billington The Synthetic Biology Project was established in August 2008 at the Woodrow Wilson International The Librarian of Congress Center for Scholars. The Project aims to foster informed public and policy discourse concerning the Hillary R. Clinton The Secretary, U.S. Department of State advancement of synthetic biology — an emerging interdisciplinary field that uses advanced science G. Wayne Clough and engineering to make or re-design living organisms, such as bacteria, so that they can carry out The Secretary, Smithsonian Institution Arne Duncan specific functions. Synthetic biology involves making new genetic code, also known as DNA, which The Secretary, U.S. Department of Education does not already exist in nature. Kathleen Sebelius Secretary, U.S. Department of Health and Human Services Work of the Synthetic Biology Project is supported by a grant from the Alfred P. Sloan Foundation. Adrienne Thomas Acting Archivist of the United States For more information about the Project visit: www.synbioproject.org Carol Watson Acting Chairman, National Endowment for the Humanities The WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS is the living, national memorial Private Citizen Members to President Wilson established by Congress in 1968 and headquartered in Washington, D.C. The Charles E. Cobb, Jr. Center establishes and maintains a neutral forum for free, open and informed dialogue. It is a Robin Cook nonpartisan institution, supported by public and private funds and engaged in the study of national Charles L. Glazer Carlos M. Gutierrez and international affairs. Susan Hutchison Barry S. Jackson This paper was produced for the Foresight and Governance Project at the Woodrow Wilson International Ignacio E. Sanchez Center for Scholars, Washington, D.C., with additional support from the Alfred P. Sloan Foundation. Opinions expressed are the authors’ own.

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