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Synthetic Biology Needs A SyntheticBioethicsPaul B. Thompson aa W. K. Kellogg Chair in Agricultural, Food and Community Ethics,Michigan State University, Michigan, USA

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To cite this article: Paul B. Thompson (2012): Synthetic Biology Needs A Synthetic Bioethics, Ethics,Policy & Environment, 15:1, 1-20

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Ethics, Policy and EnvironmentVol. 15, No. 1, March 2012, 1–20

TARGET ARTICLE

Synthetic Biology Needs A SyntheticBioethics

PAUL B. THOMPSONW. K. Kellogg Chair in Agricultural, Food and Community Ethics, Michigan State University,

Michigan, USA

ABSTRACT Recent developments in synthetic biology are described and characterized as movingthe era of biotechnology into platform technologies. Platform technologies enable rapid anddiffuse innovations and simultaneous product development in diffuse markets, often targetingsectors of the economy that have traditionally been thought to have little relationship to oneanother. In the case of synthetic biology, pharmaceutical and biofuel product developmentare occurring interactively. But the regulatory and ethical issues associated with these twoapplications share very little overlap. As such, there is some risk that focus on traditional medicalapplications, for which the ethical expertise is highly developed, will overshadow the ethical issuesthat arise in connection with land use and its attendant socioeconomic consequences, especiallyin the developing world. The 2010 report of the Presidential Commission for the Study ofBioethics exhibits this tendency.

‘Synthetic biology’ is the popular term for the domain of technoscience beingdiscussed in this paper. Usage of the term has been growing steadily both amongscientists and among the science-attentive public. Its appearance in non-technicaldiscourse exploded in the wake of publicity following a group at the J. Craig VenterInstitute’s announcement that they had successfully synthesized the genome of amicro-organism capable of regulating cellular functions, including reproduction(Gibson et al., 2010). The announcement also occasioned a series of hearings by thePresidential Commission for the Study of Bioethics (PCSB), which issued a reportin December of 2010 (Presidential Commission for the Study of Bioethics, 2010a).Much, if not all, of the discourse that occurred between the Venter group’sannouncement and the publication of the PCSB report revolved around three topics.First, the Venter group’s announcement sparked a round of speculations on themetaphysical and theological implications of the achievement. These commentsrevisited long discussed questions about what it would mean to create life, whetherthere could be anything that is inherently problematic from an ethical or religiousperspective in undertaking such a project, and whether the work done by the Ventergroup qualifies (Anonymous, 2010). Second, the announcement renewed a discussion

Correspondence Address: Paul B. Thompson, 503 South Kedzie Hall, Department of Philosophy, Ethics,

Michigan State University, Michigan, 48824, USA. Email: thomp649@msu.edu

2155-0085 Print/2155-0093 Online/12/010001–20 � 2012 Taylor & Francis

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on the nefarious use of the ensemble of techniques being developed under theconceptual umbrella of synthetic biology (Kazi, 2010; Tucker & Zilinskas, 2006).Finally, there were discussions of the potential environmental and human healthrisks from synthetic biology (Center for Genetics and Society, 2010).

These are, I submit, the ‘sexy’ issues surrounding synthetic biology: issues thatoccasion widespread comment by philosophers, theologians and general punditsof science policy. They are the topics that made it into NEW DIRECTIONS: TheEthics of Synthetic Biology and Emerging Technologies, the report of the PCSB,despite testimony before the Commission that was more wide-ranging (PresidentialCommission for the Study of Bioethics, 2010b). The discussion that followswill overlap the first and last categories to some extent, yet I will argue here thatadditional issues of ethical importance lurk beyond the reach of this triumvirate.My critique of a perspective that limits itself to these sexy issues is an implicit rebuketo the Presidential Commission’s emphasis on perspectives drawn from medicalbioethics debates over stem cells and health care reform, and to its neglect of ethicalissues that reflect environmental and agricultural concerns, as well as the philosophyof technology. I will not, however, mount a direct critique of PCSB or of theirdeliberations during 2010. I will concentrate instead on substantive issues poorlycovered by the PCSB report.

Synthetic Biology and Synthetic Genomics

The term ‘synthetic biology’ is used both within the scientific community and morewidely to indicate specific techniques for the manipulation of nucleic acids, theproducts of such manipulations and also broad programs of scientific research andtechnological development. It is not a precise term. Usage may have originatedwith a remark made by Waclaw Szybalski in a 1974 discussion of transcription,the cellular process of conversion from DNA to RNA. Szybalski speculated on theemergence of a new kind of biology in which entirely novel sequences of the fourbases from which DNA is composed are constructed and utilized both for controland regulation of transcription, and potentially for the creation of novel proteins(Szybalski, 1974). Terminological disputes are not irrelevant to the ethics of syntheticbiology. The PCSB devoted a significant amount of its energies to the use of thephrase ‘creating life’ in connection with the Venter group’s announcement of theirachievement. This, in turn, led to extended discussions not only on the meaning ofthe phrase ‘synthetic biology,’ but also theological and philosophical musings on themeaning of ‘creation’, ‘discovery’ and ‘making’. However significant these issues mayhave been to the public reception of the Venter announcement, extended definitionaldiscussion of synthetic biology is of limited relevance to the issues discussed below.

It will suffice to note two trends of scientific and laboratory practice that havebeen commonly associated with synthetic biology over the last decade. The first ofthese are programs dedicated to the identification of ‘standard biological parts’:relatively short nucleotide sequences with known functions that can be strungtogether to perform somewhat more complex biological processes. The BioBrickseffort is among the better known programs of this sort (Shetty, Endy, & Knight,2008). When realized, such efforts would allow the application of designprinciples adapted from electrical and computer engineering to the development

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and modification of organisms (Endy, 2005). The second program of research isthe construction of ever longer nucleotide sequences through chemical synthesis.This effort, represented most prominently by the Venter group, would make itpossible to construct a specified nucleotide sequence long enough to function as thegenome for an organism out of chemical bases (guanine, cytosine, adenine andthymine). Although molecular biologists have long recognized the theoreticalpotential for such programs, the Venter group’s accomplishments consist in solvinga series of technical problems in connecting and authenticating shorter strands intolonger functional units (Gibson et al., 2008, 2010).

Both separately and especially in combination, the cumulative improvementsin laboratory techniques for the standardization and assembly of gene sequencesare of interest to biologists in virtue of their contribution to the study of genomes.Genomics is a subfield of genetics concerned with the role and function of anorganism’s genome: the hereditary information encoded in DNA or, the case ofviruses, RNA (Church and Gilbert, 1984). Progress in understanding the role ofspecific nucleotide sequences within genomes was achieved through the developmentof ‘knockout’ techniques that allowed experimenters to ‘turn off’ or render certainsequences non-functional in the 1980s. Similarly, the ability to insert more complexregulatory mechanisms associated with standardized biological parts or to constructentire genomes using the assembly techniques being developed by the Venter groupwould expand the repertoire of experimental possibilities in genomics considerably.Nevertheless, this program of experimental genomics differs considerably frombiological theory and experimentation focused on physical and chemical conditionsnecessary for the origin of life (McCaskill, et al. 2007; Rasmussen et al., 2004). Whileefforts to simulate the origin of life might reasonably be classified as syntheticbiology, they are not the focus of the analysis that follows below. Thus it might bemore accurate to describe the development of standardized biological parts and thechemical synthesis of long nucleotide sequences as ‘synthetic genomics’. This usagewill be followed in the ensuing discussion. However, it should be noted that thePCSB report, as well as reports in the philosophical literature and the popular presscan be expected to use the less focused terminology in referring to the technicaldevelopments that are the primary concern of this paper.

Intrinsic Objections to Synthetic Biology

As already noted, the PCSB considered testimony on the possibility that syntheticbiology might be intrinsically unethical. Such concerns have surfaced in connectionwith a number of developments in the biological sciences at least since in vitrofertilization techniques were first used to initiate a human pregnancy in 1978. Theywere voiced widely in connection with announcement of the first successful attemptto create a mammalian embryo from adult cells in 1987 and have continuedin connection with the creation and use of stem cells. This line of descent was clearlythe focus of the PCSB, and it is noteworthy that in each of these instances, thetechniques in question are potentially associated with human reproductive activity.The PCSB did not consider environmental arguments invoking an intrinsic objectionthat have been developed by Keekok Lee and Christopher Preston. Although thereport does acknowledge Preston’s work, it does so in a context that obscures the

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specifically environmental underpinnings of his argument (Presidential Commissionfor the Study of Bioethics, 2010a, p. 136).

Although it is not my purpose to defend synthetic biology or synthetic genomicsagainst intrinsic objections, a discussion of Preston’s version of this argument willhelp to set the stage for the balance of the paper. Preston follows Lee’s suggestionthat biotechnology and nanotechnology are ‘nature-replacing’, they ‘threaten thevery existence of the natural as we understand it’ (Preston, 2008, p. 24). He cites a listof environmental philosophers that only begins with Aldo Leopold, all of whomhave argued that the naturalness of wild nature carries moral weight. He then quotesLee’s adaptation of Aristotle as clarification of what is natural in the relevant sense.‘The natural comes into existence and goes out of existence entirely independentof human volition and manipulation . . . [B]y contrast, ‘‘the artefactual’’ embodies ahuman intentional structure’ (quoted in Preston, 2008, p. 25). Preston notes that thisstatement retains ambiguities with respect to biotechnologies because (as withconventional forms of plant and animal breeding) only a small portion of theorganism’s genome is modified. The balance continues to reflect the evolutionaryhistory of the species and as such could be said to retain the original species’ internalprinciple of development. He then concludes:

But is there any technological arena in which environmentalists can still safelyuse Aristotle’s distinction in its unmitigated form to raise deontologicalobjections against manipulations of biological nature?

The answer is ‘yes’ and the arena is synthetic biology. (Preston, 2008, p. 31)

Preston then goes on to clarify his reason for making an ontological distinctionbetween biotechnology and synthetic biology with a series of statements emphasizingthe fact that to date genetic engineering has always progressed by modifying thegenome of an existing organism, while this is not the case for synthetic biology.

The products of synthetic biology do not borrow any genetic function fromgenomes produced by the historical evolutionary process. To the contrary,synthetic biology is guided by the idea of leaving evolution and existinggenomes behind in order to do a better job of creation with human goals inmind. (Preston, 2008, p. 33)

Preston notes that the genetic novelty of such products is one basis for raisingconcerns about potential risks. In this respect, he links his argument to concerns thatare acknowledged by practitioners of synthetic genomics and discussed at somelength in the PCSB report. However, Preston’s goal is to argue that in severing theconnection to an organism’s evolutionary history, humans abandon the evolutionaryprinciple of descent through modification and it is this that can be understood asintrinsically objectionable on environmentalist deontological grounds.

Although there are a number of things that might be said about Preston’sargument, I will emphasize the accuracy of his account of synthetic biology. Prestondoes not make a distinction between Biobricks and whole genome synthesis. In fact,

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projects utilizing standardized parts develop relatively short strands of DNAor RNA that perform simple biological functions (such as protein synthesis), butin order to do so they must be supported in cell culture or inserted into the genomeof an existing organism using tools of genetic engineering. They do not produceviable organisms. Projects of whole genome synthesis reproduce the sequenceof naturally existing organisms through chemical means, and this chemicallysynthesized genome is then inserted into a de-nucleated cell. The Venter groupannounced a successful ‘reboot’ of the cell and its subsequent ability to reproducein their 2010 paper. In either case, the genomes developed using synthetic biologyretain at least as much of their evolutionary history as do the products of geneticengineering.

The kind of radical break from evolution that Preston describes is certainlyimaginable, and one could plausibly argue that standardized parts and wholegenome synthesis are tools that bring scientists closer to realizing this possibility.But biologists do not currently know enough about genomes to design an entire,functioning genome ‘from scratch’. Indeed, the larger scientific aims of the Ventergroup are to experimentally probe the question of which genes in what combinationare actually required to perform the functions of regulating cellular processes,including reproduction. This is the ‘minimal genome’ project (Hutchison III et. al.,1999). It is not yet clear that this ability will ever be realized, but it has existed in thescientific imagination at least since Szybalski’s speculations in 1974. Yet if Preston’sargument carries weight as an objection to this larger scientific project, it should beequally clear that it carries no weight as an objection to Biobricks, to chemicalsynthesis of genomes or to the specific activities that are currently being undertakenunder the banner of synthetic biology or synthetic genomics. To further emphasizethis point, it is important to pry apart the sense in which the developments reviewedby the PCSB should be understood as achievements in science as opposed toadvancements in technology.

Science or Technology?

Is it more helpful to think of the cluster of techniques, discoveries and researchprograms described above as developments in science or as innovations intechnology? The term ‘technoscience’ has come into vogue as a way to blur thedistinction and to acknowledge that ever since the modern era, work at the forefrontof the natural sciences has often been accompanied by advances in the ability toconstruct or manipulate artifacts and devices, as well as the mastery of noveltechniques (Rosenberger, 2006). Clearly, the emergence of genomics as aninterdisciplinary field is emblematic of technoscience in exactly this sense. On theone hand, genomics is dedicated to the identification of a stylized gene sequencethat uniquely identifies a given species, to understanding the functionality of bothcoding and regulatory zones within that sequence and to determining the significanceof alleles for a phenotype. This description of the knowledge goals sought bygenomics researchers exemplifies the kind of activity commonly classified as science.However, the ability to even ask these questions, much less pursue them in anorganized fashion presupposes a vast technological apparatus that only begins with

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the X-ray crystallography technology used by Rosalind Franklin to collect the datathat James Watson and Francis Crick used to formulate their hypothesis on thedouble helix structure of DNA (Maddox, 2002). Contemporary genomics dependson rapid sequencing (Weber & Myers, 1997), micro-array technologies that permitnumerous parallel tests on gene fragments (Shalon, Smith, & Brown, 1996) andcomputational informatics techniques for analyzing the massive amount of datathereby generated (Quackenbush, 2001).

As such, probing deeply into whether genomics is an instance of science ortechnology might be pointless. Yet if genomics itself sits firmly within the domainof technoscience, it becomes possible to argue that synthetic genomics is bestunderstood as a technological rather than a scientific development. That is,developments such as standardized biological parts and whole genome constructiondo not substantially alter or reshape the goals or theoretical constructs that havecome to constitute genomic science. The papers in which these developments arereported do not describe aspects of gene function, nor do they publish uniquesequence information. Rather they describe techniques pertinent not only to researchactivities aimed at better understanding genomes and the role that they playin both cellular and phenotype functioning, but also to molecular evolution.Thus relative to a conceptualization of genomics as a paradigmatic exampleof technoscience, the standardization of working parts and the accomplishmentof whole genome synthesis are far more significant as developments in researchersability to perform new experimental protocols than as developments thatprovide new explanations or extend the range of theoretical concepts in genomestudies.

It is very likely that as these two technological achievements become widelydisseminated and the ability to use them becomes more efficient they will be deployedin experiments that do indeed lead to breakthroughs in knowledge. As noted above,the rationale for whole genome synthesis work at the J. Craig Venter Institute hasalways been to develop a laboratory tool that would allow them to achieve a betterunderstanding of those gene functions that are essential to cellular reproductionand development (Glass et al., 2006). At the same time, however, these tools areimmediately applicable in problem solving research contexts where the developmentof further technological capabilities, processes and products is the sole or primaryaim. They are, in other words, fairly straightforward extensions of geneticengineering (Andrianantoandro et al., 2006; Endy, 2005). However, they may not,in the short run, prove to be especially powerful extensions of genetic engineering.Cambridge University biologist Gos Micklem was quoted by the BBC with thefollowing reaction to the Venter group’s 2010 article: ‘there is already a wealth ofsimple, cheap, powerful and mature techniques for genetically engineering a rangeof organisms. Therefore, for the time being, this approach is unlikely to supplantexisting methods for genetic engineering’ (Gill, 2010). I might add anecdotal supportfrom my interactions with a number of molecular biologists who are activelyworking in plant and animal genetic engineering, virtually all of whom shareMicklem’s opinion. In short, the developments celebrated in the press and reviewedby the PCSB do not add up to the scientific breakthrough that would be needed tochallenge the ethical bar set by Preston in his 2007 article. But this should not betaken to imply that they are ethically insignificant.

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Synthetic Genomics and Platform Technology

This somewhat deflationary estimate of synthetic biology’s immediate significancenotwithstanding, the claims of synthetic biologists who believe that they are on theverge of developing technologies that will have dramatic effects on biotechnologicalcapability in the relative near term should be taken seriously. One key to thisimportance lies in the concept of a platform technology. According to Dong-Jae Kimand Bruce Kogut, ‘A platform technology represents the development of a capabilitythat maps onto a wide variety of market opportunities, a capability that isconsequently characterized by a high degree of intertemporal relatedness to a wideexpanse of new markets’ (Kim & Kogut, 1996, p. 286). The term is used in theinnovation literature to indicate capabilities within a scientific group (generally afirm) that permit a steady flow of marketable innovations, as opposed to capabilitiesthat are closely tied to a single product. Platform technologies permit firms todevelop a stream of technologically based products, each of which builds upon thetechnical capabilities acquired in the past, but that permit diversification of productlines into new markets.

Adrian Mackenzie argues that the emphasis on standards and standardizationin synthetic biology marks it as a significant departure from genetic technologyas we currently know it. Much of the genetic engineering practiced in bothcommercial and academic laboratories can be best understood as a form ofproblem solving science. The research team organizes its work around a specificgoal: efficient production of human insulin or development of Vitamin A enhancedrice, for example. Resources and activity is then organized in pursuit of this goal,and the technical capabilities, knowledge base and imagination of team membersare deployed in service to it. In contrast, synthetic biology moves innovation intowhat Mackenzie calls ‘design space’. Once a research team has developed afunctional system of biological working parts for producing a vaccine or abiologic, it will become possible to redesign the system for a much larger rangeof applications. In contrast, present day genetic engineers must, in a real sense,go ‘back to the drawing board’ with each new problem they hope to resolve(Mackenzie, 2010).

To say this is not to deny that molecular biologists have accumulated skill andexperience that has made it much easier to accomplish a problem solution. Thereneed be no sharp line drawn between the gradual and evolutionary build-up ofcapabilities associated with genetic engineering and the emergence of a technologicalplatform supporting design activities associated with synthetic biology. Indeed,sub-sectors of the biotechnology industry that concentrate on producing streams ofbiologics such as therapeutic antibodies are currently described as possessingplatform technologies (Pavlou & Belsey, 2005). Mackenzie’s point is that thedevelopment of standards will enhance the interoperability of biological parts.This will create new areas of innovation space in which more and more labs canspecialize with greater confidence that their products will mesh with work beingundertaken in other settings. Drew Endy’s vision of synthetic biology emphasizesthat this will permit the emergence of a less profit-driven set of platformtechnologies, much as open-source codes have fueled innovation in informationtechnology (Canton et al., 2008).

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There is little doubt that scientists in the overlap areas of genetic engineering andsynthetic genomics are utilizing the language of platforms and design to characterizetheir work (Keasling, 2006; Rochfort, 2005; Stafford & Stephanopoulos, 2001).The work of Jay Keasling is an often cited example. Keasling is the key figure in aconsortium that includes The Gates Foundation, his academic lab at the Universityof California-Berkeley, and his company Amyris Biotechnologies of Emeryville, CA.Their larger strategy is a stream of products based on the insertion of syntheticgene constructs into E coli (Wilan, 2005). The lead product is a synthesized version ofartemisinin, an anti-malarial biologic (Hale et al., 2007). Artemisinin can be derivedfrom plants in the phylum Artemisia (Duke et al., 1987). It has been used as a folkmedicine for treatment of malaria in China since antiquity (Klayman, 1985).According to the Amyris website, the company ‘has granted a royalty-free licenseto this technology to sanofi-aventis for the manufacture and commercialization ofartemisinin-based drugs with a goal of market availability by 2012’ (Amyris, nd).As an example of what platform technology implies, Amyris is elsewhere describedas a bio-fuel company developing a microorganism that will allow directtransformation of sugar into diesel (LaMonica, 2010).

The Ethics of Synthetic Biology Platforms

Probing the ethics of artemisinin does not present large conceptual difficulties,though the intricacy of the task should not be minimized. As an important anti-malarial compound there is an obvious ethical rationale favoring technicalinnovations that increase or stabilize its supply or that lower its cost. There arepotential unintended consequences from the Amyris project that begin with productsafety and then continue the logic of risk analysis. It is not obvious that containedmanufacture of artemisinin by synthetic organisms poses significant ecologicalrisk, but it is clear that increasing the use of artemisinin could hasten the evolutionof artemisinin resistant malaria. There are also socioeconomic impacts, mostespecially on the wormwood growers who have hitherto been the source of mostcommercially available artemisinin. This final point was raised by Jim Thomas of theETC Group in his testimony to the Presidential Commission for the Study ofBioethics in August of 2010 (Presidential Commission for the Study of Bioethics,2010b). A full discussion of this concern would need to probe into the disincentivescurrently faced by wormwood farmers (Van Noorden, 2010), but the larger pointhere is that this problem might well be resolved with appropriate compensation toeconomically displaced producers

Biofuels present significantly more complex challenges to ethical analysis. Thereare compelling environmental arguments for technological innovation that wouldenable replacement of fossil fuel with plant-based or microbial production. Althoughcombustion of fuels from biological sources would release heat and carbon, bothwould have been recently converted into biomass, resulting in a so-called carbonneutral process (Oliveira, Vaughan, & Rykiel, 2005). However, it has been widelyrecognized that an accurate assessment of biofuel impact on climate requires a moredetailed analysis of the entire life-cycle of a biofuel as well as changes in land-usepatterns (Fargione et al., 2008; Johnson, 2009). Biofuels also became embroiled inethical controversy in 2007 when a spike in world food prices led to widespread

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speculation that diversion of the US corn crop into ethanol production was theculprit (Boddiger, 2007; Runge & Senauer, 2007). There continues to be debateamong analysts as to how much of the 2007 food shortage could be attributed tocorn ethanol (Alexandratos, 2008; Tyner, 2008), as well as whether it would bepossible to develop a finely tuned subsidy policy that would provide incentives forbiomass production without also causing a surge in food prices (Srinivasan, 2009).The Nuffield Council on Bioethics produced a comprehensive report on the ethicsof biofuels in April 2011.

The tricky economic debates notwithstanding, publicity over the food vs. fueltension has provided even more impetus to biofuels that would be derived fromsynbio technology platforms. The number of technical possibilities here is large andI will simply try to convey the general idea rather than attempting a specific survey.Currently, biofuels are primarily limited to ethanol derived from plants such as sugarcane, sugar beet and maize, or biodiesel derived from vegetable oil (Demirbas, 2007),all of which can also be consumed for food. In the wake of the 2007 crisis,a consortium of economists, ecologists, agricultural scientists and energy expertspublished a short paper in Science calling for strategies in biofuel technology thatwould secure some of the hoped for environmental benefits but would avoid the foodvs. food dilemma by concentrating on non-food sources of biomass (Tilman et al.,2009). The strategies for doing this include developing enzymes or organisms thatmore rapidly and efficiently convert cellulose to sugar, producing non-food plantsthat are genetically modified to be more readily processed into fuel and convertingsolar energy directly into liquid fuel using microorganisms. All of these strategiesinvolve advanced genetic engineering and many would utilize at least some elementsof standardized biological parts or whole genome engineering (Newman et al., 2010).

What should we make of this from an ethics perspective? The Nuffield Councilreport proposed an ethical framework for the evaluation of biofuel projects basedon six key principles.

(1) Biofuels development should not be at the expense of people’s essential rights(including access to sufficient food and water, health rights, work rights andland entitlements).

(2) Biofuels should be environmentally sustainable.(3) Biofuels should contribute to a net reduction of total greenhouse gas

emissions and not exacerbate global climate change.(4) Biofuels should develop in accordance with trade principles that are fair and

recognize the rights of people to just reward (including labour rights andintellectual property rights).

(5) Costs and benefits of biofuels should be distributed in an equitable way.(6) If the first five Principles are respected and if biofuels can play a crucial role

in mitigating dangerous climate change then, depending on additional keyconsiderations, there is a duty to develop such biofuels (Nuffield Council onBioethics, 2011, p. xxv).

The highly qualified endorsement enunciated in Principle 6 provides a basis fortaking biofuel applications of synthetic genomics quite seriously from anenvironmental ethics perspective. Obviously, a full application of the Nuffieldframework to any given technology platform would require both substantial

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empirical description and extensive interpretation of each principle. What followscan be regarded as some preliminary observations along those lines intendedprimarily to support the larger thesis of the present paper.

Biofuel Applications: Substantive Ethical Concerns

First, it is important to deconstruct some of the thinking behind the food vs. fueldebate. While it may seem obvious that rising food prices present difficulties for poorpeople, rising food prices are not a unilateral moral evil. Approximately one halfof those in extreme poverty live in rural areas. Although not all of them are farmersor herders, most depend either directly or indirectly on agriculture. Their lives arebettered when the local market for what they produce is strong, and worsened whenagricultural prices are low. Marcel Mazoyer and Laurence Roudart have assembleda powerful analysis of this issue. They argue that many of the poorest farmers cannotrecoup even the meager costs that they presently incur in producing their crops andlivestock. Mazoyer and Roudart believe that they must both increase the biologicalproductivity of their farming methods and benefit from a gradual increase in worldfood prices to achieve even minimal levels of security and well-being (Mazoyer &Roudart, 2006). But Wall Street Journal reporters Roger Thurow and Scott Kilgoreprovide anecdotal case studies of what happens to subsistence farmers who doimprove the biological productivity of their farming methods. Succinctly, they arebankrupted by US and European products that are sold below the cost of theirproduction. In a double irony, even famines do not lead to an increase in pricesfor the crops of local farmers. The food needs of the hungry are met by food aidcontributed from US farms while crops that could feed local populations sit unsoldin warehouses (Thurow & Kilgore, 2009).

Before proceeding further in this analysis, it is important to qualify the argument.There is no such thing as an average farmer. Subsistence farmers in Mali growcotton. They need to buy food just like poor people in cities. What they need is anuptick in fiber prices and a decline in food prices. As subsistence farmers can growcotton or coffee, there is no intrinsic reason why they could not grow crops forbiomass themselves. In that case they would be direct beneficiaries of syntheticbiology platforms, but only if food does not become so expensive that they cannotafford it. Yet the point to stress here can still be pressed even in light of numerouscaveats and qualifications that would need to be made in predicting impacts on poorpeople in any specific location. It is that from an ethics perspective the food vs. fueldebate has always been too simple-minded. With better functioning markets andfood entitlements, burning US corn in SUVs could be a very good thing for poorpeople in the developing world. At the same time, those that are depending onlimited incomes to buy food benefit when food prices come down, even if they do soas a result of market distorting subsidies that drive local farmers into starvation.What can be good for some poor people can be bad for others. We might call this thefundamental antinomy of agricultural ethics.

The debate is also too simple-minded in another respect. Given that hunger is acurrent and terrible reality, as Thurow and Kilgore document, and given that poorfarmers are not benefiting from rising food prices for complex economic reasons, it isnaı̈ve to think that shifting biofuel development away from food crops is an ethically

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adequate response. Over the course of a year or less, the volatility of food prices isexacerbated by the tight linkage to oil prices that the corn ethanol market created,and it is reasonable to think that moving biofuels away from food crops will lessenthat volatility. But over the long run, the underlying issue is land use. And it is notjust that land used to grow miscanthus, jatropha and woody plants for celluloseor land set aside for pools of algae or prokaryotic organisms that transform sunlightinto liquid fuel can also be used to produce food. The larger problem is thatwhen you have a technology that allows this kind of land use, the value of land isdramatically transformed. Arguably synthetic biology platforms are already having amassive effect on poor people in Africa, as news reports have documented the effectsof speculative investment in land currently occupied by herders and poor farmers(Cotula, 2010; MacFarquhar, 2010; Vidal, 2010; Wengraf, 2010). The UN Food andAgriculture Organization has issued a report urging both caution and possible policyremedies as African nations eager to encourage foreign investment have becomeopen to these speculative land sales (Cotula et al., 2009).

Although unraveling the moral complexities in biofuel development couldcontinue at greater length, it is perhaps better to consolidate the argument thatthis brief accounting of the biofuels debate is intended to support. The not very sexyissues that arise in connection with synthetic biology become visible when it isunderstood as a set of core technologies that expand both the reach and the speedof biotechnology. One can quite plausibly see these capabilities as an evolutionarydevelopment of animal and plant breeding activities that congealed into technicaldisciplines during the nineteenth century. Nevertheless, steady progress in expandingthe power of these disciplines has been made over the last four decades. If Preston’sview is overstated, synthetic biology nevertheless represents a significant, if alsoslightly vague, threshold. It is a technological threshold rather than a conceptual one.The standardization of biological parts and the ability to synthesize large pieces ofDNA are to biotechnology what interchangeable parts and the factory were first tomunitions and textiles and later to all manufacturing. As a long line of reformersbeginning with Robert Owen called for society to take broader cognizance of thesocial and ethical consequences of the industrial revolution, it is incumbent upon usto recognize the full scope of developments in biotechnology. This is a key ethicalcontext in which the tools of synthetic genomics must be evaluated, and it is acontext largely missing from the PCSB report.

A Possible Objection Countered

There is an objection to this line of reasoning that lays all the world’s problems at thesynthetic biologists’ doorstep. ‘Wait a minute!’ the objector might say. You start outtalking about synthetic biology, but dismiss the obvious ethical questions thatbioethics is primed to ask. You move quickly to a debate over the use of genetictransformations to develop new medical products as well as biofuels. You try tocomplicate the medical applications by linking them to biofuels, but these are issuesthat are best kept distinct. Furthermore, these applications may or may not utilizetechniques that we can characterize as synthetic biology as opposed to ordinarygenetic engineering of plants and microbes. Although you have produced citationswhere authors link biofuel research to synthetic biology, it is equally possible to find

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citations that mention genetic engineering but not synthetic biology (Sticklen, 2008).But your exaggeration does not end there. You go on to talk about poor farmerswho are bankrupted by dysfunctional global markets, and then you produce recentreports linking rising land prices to speculative investment that anticipates thesuccess of new types of biofuel. Now you seem to be talking about a problem thatis much larger than even biotechnology. You even admit that this problem mightbe thought to be a fundamental ethical issue in agricultural ethics writ large!At the very most, this is a problem with biofuel, which is only one application ofsynbio technology platforms. Although there may be ethical issues here, thisobjection concludes, to characterize them as ethical issues for synthetic biology is anon sequitor.

In reply I will begin by noting that while the thrust of this objection is to attack myargument on the ground that it fails Descartes’ test of relying on clear and distinctideas, the point of the original argument was to present the case for a less reductivestandard of clarity on the grounds that the reigning categories in bioethics andin public policy are leading us to miss the larger picture. There is thus a sense inwhich the objection simply begs the question I have tried to raise. Nevertheless, as aperson trained in philosophy, I am as constitutionally inclined to keep my peasseparate from my mashed potatoes as the next person. As such I will try to offersome clarifying philosophical points before reasserting my primary claim. First I willsuccinctly reiterate the case for seeing synthetic biology as a significant technologicaldevelopment that both extends but also substantially changes what we have cometo understand as biotechnology, then I will argue that we need a better way to thinkthrough the ethics of large scale technical change.

While much of the genetic engineering that has been done up to now could beaccurately described as craftwork, the synthetic biology era will see platforms thatallows the design of biotechnology applications to be somewhat separated fromactually building them. This, in turn, allows for advancements in both design andinstrumentalization to build upon one another in an exponential, rather thanadditive, way. It is, I submit, a mistake to approach the social and ethicalconsequences of a technology platform as if each particular application were a single,isolated action, for the whole point of conceptualizing technical developmentsas platforms is to think of how applications in seemingly discrete domains can bepursued simultaneously and even interactively. To think narrowly deprives us of theability to recognize the far reaching consequences of technical capabilities andobscures the responsibilities that go with them.

But who is it that is thinking narrowly here? It not the scientists and entrepreneursdeveloping synthetic biology platforms that are thinking narrowly. They are theones using the language of platforms and forming both for-profit companies andnon-profit labs where medical, environmental and agricultural applications arebeing developed in parallel. It is the bioethics community that is thinking narrowly.The ethical and policy response developed in New Directions, the report of the PCSB,exemplifies what I have elsewhere described as a ‘purification’ approach to the ethicsof biotechnology, a term I use to avoid the tangle of confusion that arises when suchan analytical strategy in ethics and policy is referred to as reductionistic. Purificationaccepts a standard categorization of the scientific disciplines that is reflected in theway science is institutionalized in both academic organizations and in public

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agencies, including regulatory agencies. This categorization is reflected even in ELSIstudies of science and technology, where social scientists, philosophers and otherhumanists who study therapeutic applications have relatively little interaction withthose who study public health, and even less with those who study environment, foodor agriculture. I do not deny that there are ways in which the specialization producedby purification serves us well, for it allows us to better comprehend and reflect therelevant biological mechanisms and social context for activities that have beenin truth functionally distinct from one another in terms of the relevant networksof actors and technical means. Where it has failed us is in our ability to grasp andconsider responsibility for the larger socioeconomic impacts of technical change(Thompson, 1997).

Purification is also the strategy that underlies a lot of thinking about risk,including the analysis of environmental risks contained in the PCSB report. Thecrucial point is a sharp distinction between biological and social hazards, on the onehand, and between biological and social mechanisms of exposure, on the other.In short, biologists analyze the risk of impact on ecosystems or non-target species,while economists and sociologists analyze the risk of financial loss or displacement.While the intentions and behavior of human beings are admittedly relevant to socialrisks, they are seldom seen as relevant to the materialization of environmentalhazards. A classic study of risk assessments for agricultural chemicals shows howanalysts trained in the natural sciences were blithely ignorant of actual humanpractice in the handling of these materials, while social scientists simply assumed thatthey had no business in analyzing the potential for toxic events (Brunk, Haworth,& Lee, 1991).

In contrast to purification, I argue, many ordinary people adopt a practiceof hybridization. This philosophical way of seeing the organization and con-sequences of technology deploys a number of initially plausible tropes in developinga worldview that associates risk to health, personal security and to the environmentwith threats to personal livelihood and social upheaval. The epistemic flexibility ofour ordinary language concept of risk facilitates the elision of uncertainty about factswith uncertainty about an agent’s intentions or willingness to take responsibilityfor a threatening course of events (Thompson, 1997). What is more, unequal accessto information is the precise circumstance that underlies some paradigmatic cases ofrisky activity, like buying a used car (Akerlof, 1970; Cranor, 1999). In a hybridizedworld view biological hazards may be more likely to materialize because peopleinvolved in their development and deployment have questionable moral character.In a hybridized world view, synthetic biology may be risky because it is a basis fordisruptive land speculation in Africa: if the people developing synthetic biologywould allow that to happen to some of the world’s poorest people, how can we trustthem with our health?

I do not introduce the hybridized worldview to suggest that this is what should beadopted. In particular I do not follow Jim Thomas and the ETC group in concludingthat the messy socioeconomic causality of dramatic new technical capabilitiesprovides a sufficient reason to both oppose the application of synthetic genomicson political grounds, and even to pursue deliberately obscurantist practicesof hybridization in public discourse. There is a large gap between moral philosophiesthat assume purification, on the one hand, and common sense hybridization,

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on the other. My point is that the ethics of emerging technology needs to dive intothat gap and come to terms with it. As in the original 1997 paper, I do not reallythink that what has been said here does much more than diagnose this situation withrespect to synthetic genomics. So in concluding I will offer a brief hypothesis onhow to move forward.

Concluding Moral Hypotheses

The complex socio-environmental and economic interconnections that arise inconnection with platform technologies such as synthetic genomics might usefully beinterpreted as imposing imperfect duties on the community of scientists, fundingagencies and economic investors that make up the network bringing this technologyforward. In the philosophy of Immanuel Kant, the distinction between perfect andimperfect duties is developed to explain and clarify the difference between thosespecific duties that moral agents are at all times obligated to perform, and those thatleave room for choice and interpretation. Prohibitions against lying or murder areperfect duties for Kant, while duties of charity are often cited as the leadingexample of an imperfect duty. Doctrines of imperfect duty, including Kant’s own,involve a number of problems that are well known to philosophers (Hill, 1971),and so an adequate statement of my hypothesis would be a much larger task than canbe undertaken in the present context. As such what follows here is a bare sketch ofwhat assigning imperfect duties to the developers of synthetic genomics mightinvolve.

One of the things that the thrust of purification gets right is that there is very littlethat a given agent can do to prevent or redress events like the current land grabin Africa. This is the case whether that agent is an individual scientist or even anorganization such as Amyris Biotechnologies or the J. Craig Venter Institute. A moreproximal responsibility must certainly be assigned to the investors that effectingthese events, and to the governments and inter-government agencies that arefacilitating it. What hybridization gets right is that absolving the synthetic biocommunity for all responsibility is a bit like arguing that the firearms industry hasno tie to gun violence on the ground that ‘Guns don’t kill people; people kill people.’By analogy, what seems to be called for is an organized and concerted effort on thepart of the broader biotechnology community to promote awareness and moredetailed understanding of both the forces that lead to such indirect, but highlyproblematic outcomes, and of possible remedies. Remedies might well take the formof policy change or attempts at shaming or international persuasion, but there mayalso be remedial action that can be taken at the level of which technologies actuallyget developed, and their specific land use profile. On the face of it, biofuels that couldbe integrated into smallholder productions systems seem friendlier to the poor thanapproaches requiring large scale technological systems, such as massive algae lakes,for example (Nuffield Council, 2011).

In fairness to the Presidential Commission for the Study of Bioethics, the NEWDIRECTIONS report does call for democratic deliberation on the future of syntheticbiology, and it supports this call with specific recommendations. Specificrecommendations encourage scientists, policy makers and religious, secular andcivil society groups to maintain an ongoing exchange of views, call for accuracy of

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language and direct the Executive Office of the President to promote scientific andethical literacy. Perhaps that is what ‘promoting awareness and understanding’which I referred to above, comes down to. Yet I would argue that somethingstronger is needed than the Commission’s language. First, I argue that promotingawareness and understanding is an imperfect duty that falls on members of thesynthetic biology community. This is a significantly stronger statement than simplysaying that it would be a good thing for deliberation to happen. To say that theresponsibility for ensuring that deliberative activities actually occur falls on syntheticbiologists is to say that collectively, the scientists, administrators and funders of thisinitiative will have failed morally if the broader impacts of this technology are notinvestigated and what is learned about them broadly disseminated. To say that this isan imperfect duty is to acknowledge that the responsibility must be shoulderedcollectively through institutional mechanisms that have yet to be created.

Second, the imperfect duty I envision goes beyond talk. When it is possible todevelop applications of synthetic biology (or indeed any biotechnology) with landuse implications that are more conducive to the interests of economically marginalsmallholders, there is a prima facie obligation to do so. The known difficulties ofagricultural development and debates over Green Revolution technologies provideboth the basis for claiming that this is a prima facie obligation, and also that it is onlya prima facie obligation. The devil will certainly be in the details when it comes toagricultural technology, and it is difficult to go much farther than this at the presenttime. Nonetheless, this claim about the socioeconomic impact of synbio technologyplatforms is much stronger than anything in the Commission report, which seemsto focus only on the distributive justice of access to technology, and does notacknowledge that synthetic biology could play a significant role in worsening the lotof the world’s poorest people even further. Third, when applications for which thereare compelling health or environmental rationales do displace economicallyand politically weak people, the biotechnology community has an even strongerobligation to lobby for and effect schemes of compensation whenever possible.Amyris says that it is already doing this in the case of wormwood farmers.

Fourth, recognizing the moral legitimacy of socioeconomic impact will requirethe development of a substantially more nuanced account of governance than theCommission report offers. I cannot really fault the commission here, for work onnon-traditional governance regimes is very much a work in progress among scholarsof emerging technology (Kuzma et al., 2008; Macnaghten, Kearnes, & Wynne, 2005).As a government agency, the Commission may also have been understandablysensitive to any hint that the government should pick winners and losers whenit comes to competing technologies. But examples of the role that novel blends ofgovernment and governance can emerge could be found in the food biotechnologyarena. A major controversy over cloned livestock involved the civil society call forrestrictions and labeling and the US Food and Drug Administration’s view that itlacked authority to regulate on any but narrow human and animal health grounds.Although this situation is far from resolved, the main cloning companies hoping toprofit from this technology have developed a voluntary regime that will keep clonedmeat off the market. They did this with informal and unofficial encouragement froma wide cross-section of stakeholders, and FDA staff were frequently in the roomwhen these conversations occurred.

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Finally, the NEWDIRECTIONS report illustrates my concerns about purificationby reflecting a rather narrow medical bioethics orientation to the ethics of emergingtechnology. The emphasis on information accuracy might itself be interpreted as an

endorsement of purification, though I would not go that far in my criticism.However, there are limitations both to the report itself and to the range of issues

considered during public hearings that testify to my concern. As noted alreadytestimony included statements from ETC Group, long known for opposition

to GMOs, as well as from Dr. Alison Snow, an ecologist with expertise on theenvironmental impact of GMOs. However, Jim Thomas of ETC group providedthe most cogent testimony on social impact, and should not have been regarded as an

unbiased analyst of the debate over GMOs. The aforementioned emphasis on accessto technology in the report’s discussion of social justice reflects a lack of appreciation

for the way that technical change can destroy livelihoods and ruin lives. The reportcites the Ethics Advisory Board of the long-running Framingham Heart Study as

a successful effort in ongoing public dialog over technology. As salutary as this effortmight be, it pales in comparison to the creation of both national and stateagricultural extension services as authorized by the Smith-Lever Act of 1914.

Extension had both numerous successes and some notable moral failures(Birkhaeuser, Evenson, & Gershon, 1991; Daniel, 2007), but it remains an exemplary

case study for democratizing technology that is simply not on the radar screenfor many bioethicists. The report’s brief discussion of biofuels—clearly one of the

signature applications for synthetic biology—mentions land use debates but does notmention any of the potential human consequences I have discussed above. As such,it may be worth stressing the point that the public dialog being recommended by the

Commission will need to be much broader and encompassing than the current dialogover biotechnology, where scholars who study stem cells and biotech drugs

infrequently talk to scholars who study GMOs.

And Finally…

I would not claim to have offered either a sufficiently rich specification of the

suggestions made in my concluding moral hypotheses or an even minimally adequatephilosophical argument for regarding them as moral duties. My larger purpose has

been to argue for a significant broadening of the range of ethical perspectives,concerns and contexts in which the cluster of activities being advanced under the

banner of synthetic biology are evaluated. The concluding hypotheses are offeredsolely as illustrative of the proposals that might be entertained in an adequatebioethics. There are two substantive claims pertinent to this larger purpose for which

I believe that I have supplied arguments. First, the synthetic biology we arediscussing in the second decade of the third millennium is actually synthetic

genomics: a cluster of tools usefully viewed as a platform that allows for bothconceptual and practical interlinking of scientific research activities with commercial

product development spanning a wide variety of hitherto distinct markets andsectors of the economy. It is in this respect an advanced form of genetic engineering,significant primarily in its impact on the speed, simultaneity and diversity of results

obtained.

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Second, because synbio synthesizes socially as much or more than it synthesizesbiologically, we need a new way of thinking in bioethics. One element we needincludes more focus on technology as opposed to scientific advance. Technologyplatforms in synthetic genomics do not represent an important breakthroughin scientific understanding, but they do have immediate and far ranging effects onlaboratory practice across a wide array of social arenas: academic institutions,as well as the health, agricultural, energy and military sectors of the economy.We also need to be able to examine ethical issues that arise simultaneously ineach of these sectors. We are institutionally organized to specialize in a mannerthat regards these arenas as distinct. Ethics and policy institutions are attuned todistinct problem sets and reflect a similar organization that aligns key scientificdisciplines both with certain industries and with corresponding regulatory-orientedorganizations inside government and in the non-profit sector. Even civil societygroups organized to monitor events and pressure government reflect this formof purification. Nevertheless, the corresponding alignments in the respectivesciences and the for-profit sector are being transformed by a new generation oftechnologies. Synthetic genomics is, in fact, but one of the developments creatingtechnology platforms that build bridges between hitherto separate domains of socialpractice.

The current Presidential Commission for the Study of Bioethics largely reflectsan old point of view, a point of view that is also reflected in academic programswhere medical bioethics has little interaction with environmental philosophy, andwhere even environmental philosophers are generally ignorant of developmentsin industry or agriculture. This point of view is especially in evidence in thosesections of the PCSB report discussing Christopher Preston’s work. Preston’s viewis listed among other viewpoints claiming that products of synthetic biology areunnatural. All these views are then subjected to a blanket dismissal in which thereport’s authors go on to acknowledge that concerns about unintended consequencesof technology are legitimately considered in terms of risk. Issues concerninghuman health and reproduction are the centerpiece in this hierarchy, the home basefor sexy issues that command attention from press and public alike. Intrinsicarguments are referred to the continuation of the human species alone.Environmental issues become meaningful solely under a biologically determinedconceptualization of risk (Presidential Commission for the Study of Bioethics, 2010a,pp. 135–140).

This comment is not meant to imply support for Preston’s thesis against theanalysis of the PCSB. Indeed, very much like my response to Preston offered above,NEW DIRECTIONS responds to all intrinsic objections by questioning whether thecurrent capabilities of synthetic biology are as powerful in reality as they are inthe imagination of its critics (Presidential Commission for the Study of Bioethics,2010a, p. 129). Yet the swift translation of an argument offered explicitly ondeontological and environmental grounds into a risk-based domain where biologicalexperts hold sway exemplifies a form of moral purification that cannot be regardedas consistent with the PCSB’s call for more careful moral discourse. Seriousevaluation of the suggestions made in my concluding hypotheses will require asubstantially broader conversation, a synthetic bioethics adequate to the platformtechnologies of the twenty-first century.

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