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The approach developed in this work aims to point out the stakes and challenges that animate the field of synthetic biology.

As observers, we also have challenges and responsibilities. We will now use this third part to face questions about governance of the discipline, challenging our ethical reflexion with a realistic perspective. Thus, a topography of actors and decision making processes will enlighten us about what is “possible”, “thinkable” in order to fulfill what is ethically necessary. We also use this part to put a last look on fundamental concepts about the new perceptions brought by the discipline and by the actors, in order to get at how these topics will affect our societies.

Briefly and schematically, we can have a look on our previous reflexions and observe that we had to consider two sets of stakes and challenges to impose into the consideration of the actors of the field.

That stakes are technical and social. As I try to figure out in my methodology and criticism, technical and social questions have to be regarded together, because of their common dynamics and co-construction processes. For example, how to distinguish the “Synthia” project from the Venter Institute, the bacteria which is not yet materially designed but already patented, from the question of the artificial life and the theme of intellectual property?

Social and technical stakes are also commonly involved in the necessity to define who is going to have decision making power in the field. What position will be obtained for the one who succeeds in the decision on standards? What dynamic permitted Venter and his Institute to be a major actor in the field of synthetic biology if it isn't by his participation in the race of the Human Genome Project? Both elements have to be regarded together, as in biosecurity and biosafety concerns and proposals : technical, legal, institutional, etc.

However, asking “who decides?” is nonsense if we do not, in the same way, talk about the people and practices concerned and involved in the decision and its consequences : practitioners, students, patients, States, populations, etc. We hope to make something like topography of these actors.

Synthetic biology, facing these debates, both feared and loved, questioned by others field of science, non scientists, institutions, politicians, NGOs, is kind of “forced” to rule, decide and pick its practices, actors, norms, regulations. That “need” of form seems to indicate the relative youth of the field. These decisions, not yet taken, these rules not yet settled, still permit the existence of numerous divergent and conflicting initiatives. That plurality won't disappear with new regulations, but, markers of differentiations will be built and sides will have to be chosen. That youth is also visible through the nature of the stakes formulated: contemporary figures of risks, opensource's questions, DIY experimentation, etc. We will try to put into light how that youth can modify the potential development of the regulation of the field.

A. What form for what life science?

One of the most fundamental stakes about governance will be about standards. Constitution of standard is both technical and strategical for actors, by the essential part standards could play in the constitution of a community and its habits, process in production. Thus, the movement to determine norms of production will determine uses, actors who will organized themselves through it, tools (lets think about BioBrick™) and the form of the following standards (which will be build regarding the previous). Decisions about standards are strategic : the one who will succeed in imposing the norms will be a fundamental actor of the science production.

1) Why standards?

The initiative of a standardized biology can be read in numerous perspectives, answering to experimental, practical and theoretical needs of biology. Standardization, through it “rational” part and simple decomposition, proposes a new way to wonder about the complexity of life. Drew Endy considers that it offers a “direct and compelling method for testing our current understanding of natural biological systems”. That new theoretical approach, that pragmatical perspective in order to answer unsolved questions has too its practical and experimental counterpart : knowing how a biological system is functioning implies being able to control it. We are now getting to the canons of production of engineering, now biological, mentioned in our previous reflexions. As Ben Howel shows it (Auyoung et al. 2007), standardization in history of technique is mostly about two stakes. Referring at Michael Kershaw’s work in "The international electrical units: a failure of standardization?" Studies in History and Philosophy of Science 38 (2007): 108-131) : Standards had “to support the work of scientists taking precision measurements” as well as “commercial measurement systems”. Howel also reveals that the aim of standardization was about resolving security problems : the technical norm permits assurance of the well functioning of the systems which rely on it, permitting its evaluation. The place of techno scientific standards does not need to be proved anymore in the technology that surrounds us, but Howel notices that standardization process wasn't present in the field of genetic engineering. That way, synthetic biology is disconnected from its disciplinary parents and developed its own engineering approaches through abstraction and calibration.

2) Popularization of standard as a strategical stake

Howel offers us a luminous comparison to explain the popularization process of standards in synthetic biology. Howel compares it to the establishment of the big technical standards decided in the 19th century (as railroad, electrical measurement, etc). Technical norms, in the 19th century in a climax of industrialization process, were decided in large international meetings, congresses of norms' constitutions. Thus, delegations of engineers were meeting in order to establish norms. That centralization of decision making is totally unversed in popularization of standards in synthetic biology.

The initiative from MIT, Harvard and University of California of San Francisco's researchers, through constitution of the BioBricks Foundation is a vary different system for standardization. The BioBricks Foundation provides the material and management support of the Registry of Standard Biological Parts (a collaborative registry initiated and managed by MIT, making publicly and freely available access to DNA sequences and characteristics of BioBrick™). A BioBrick™ is a « is a standard for interchangeable parts, developed with a view to building biological systems in living cells ».

The standardization process is in the restriction enzymes used : the only accepted enzymes are EcoRI, XbaI, SpeI, and PstI. The collaborative form we are about to point out is not present in the choice of these norms, these enzymes have been chosen by the Tom Knight and other laboratories are using different enzymes.. The local and university initiative of the conception of the standard BioBrick™ show that the strategy of development and establishment of BioBrick™ as norms is not a centralized strategy, embodied in international organizations and decided in large meetings of engineers. US researchers have developed a strategy of aleatory proliferation by the use of BioBrick™ and, in that aim, had to make choices with social consequences. Thus, the Registry is based on the model of opensource template, deeply collaborative, it relies on the principle “get some, give some”. Everyone can get, everyone can give and, most of all, the database is enriched by users. We don’t have to forget that this “get some, give some” is only an academic privilege, if we remember the Steve Kurtz case, the safety issues are often used to prohibit access to non scientists.

This collaborative and participative model refers to development models of free and opensource software. Indeed, the main characteristic of information is that it is a “uncompetitive good” : consumption is not making the good disappear or lose its value but, on the contrary, the more the good is consumed, the more value it gets. This model is essential in free software development, contribution of users often permitting to keep the software free and increasing the possibilities of amelioration.

The BioBrick™/Registry initiative relies on the largest use to make its standard established. In order to fulfill this goal, IGEM is a strategic operation. In 2009, 110 teams and about 1200 participants are involved in the competition and are constrained, by the rule of the competition, to respect the BioBrick™ norms : encouraged to use existing BioBrick™, committed to use the four enzymes of restriction to build systems with it and encourage to make most of it available on the Registry. By the management of an event, a “science concourse for undergraduates students”, MIT and the BioBricks™ Foundation are able to influence practices of young and motivated students from universities all around the world.

I didn't had the occasion to search in-depth other initiatives of standardization, but, they are totally conceivable. The internationalization of the norm does not rly on centralization. We can say that the development of the 19th century technical standards was at the image of the mode of government and exchange of the time, relying on centralization, bureaucracy, top-down decision and industrial capitalism. Differently, biological standards relied on liberal dynamics : free competition, local, intellectual and academic initiatives, referring to economy of knowledge, and relying on canons of liberalism. This possibility of free divergence, opening to debate, to compeition, but also to a culture of open science : concourse of young student and opensource models to support the establishment of norms.

As already mentioned about standardization, the missing of any center of decision permits divergent and competing initiatives. The “scientific public” can make its choice and “may the best win”. The pragmatic marker and the liberal culture is particularly visible. As in the opensource communities, the idea that the community is best able to choose the good standard seems to be working. The work of Janet Hope is mostly focused on promoting opensource business models applied to biotechnologies, relying on all kinds of strategies and innovative models permitted by opensource. Thus, thinking of the Richard Stallman slogan, the main idea is close to "free software is a matter of liberty, not price”. To understand the concept, you should think of 'free' as in 'free speech', not as in 'free beer'. The opensource models are not anymore opposed to a merchandise logic.

B. Self or Exploded governance?

Relationship with market has also to be through the positioning of actors, in particular regarding “out of science” matters, such as social and ethical implications.

From that perspective and in a ethical and activist approach, the ETC group, a non-profit civil organization of expertise on « the socioeconomic and ecological issues surrounding new technologies that could have an impact on the world’s poorest and most vulnerable » criticises the Report on Synthetic Biology Governance from the J. Craig Venter Institute and Alfred P. Sloan Foundation in their report Syns of Omission (ETC 2007). The ETC group authors critique the pseudo impartiality of the report’s proposal of regulation, wrongfully presented as a "project to examine the societal implications of synthetic genomics ».

The main critic of ETC group is the self governing both proposed and performed by the researchers. And, by reminding us that the Alfred P Sloan Foundation is financing this report with around half a million dollars, the ETC group brings out the partial orientation of conclusion. The Foundation of A P Sloan, former boss of General Motors, is working on science and technology topic, but is mainly focused on terrorism concerns. The ETC group points out that the bioterrorism risk is over accentuated, and that scientific errors are minimized. The report is denounced by Jom Thomas from ETC group as a “partial consideration of governance by a partisan group of authors".

Legitimacy of discourses, through the question of internal or external critic is making the question of governance more and more complex. How should we consider civil society in a decision making process about such a technical subject? If trust in scientists about such important concerns is not possible, what other subjects should be governed by the whole society? What about other fields which are equally important? Is a real consensus with so many actors thinkable? Aren't we about to put our trust in the best speaker? Won't it be, in the end, a scientist? Even deeper, how should we consider the border between the internal and external standpoint? Aren't we always on both sides?

We have already mentioned non-scientist participation in these decision making processes, in a macroscopic way and we put it as a principle. The ETC group enlighten how private interests can build up biosafety and biosecurity concerns have already been raised. However, two additional social stakes mentioned by the ETC group are:

  • Economics : synthetic biology is a capital-intensive technology likely to have massive downstream impacts on marginalized peoples if it is adopted and promoted. Impacts will come first in agriculture and health but then in geo-engineering climate change. Synthetic microbes programmed to make industrial substances could potentially de-stabilize South economies and employment.
  • Control : like biotech, companies are already patenting critical synthetic biology technologies and processes. Although some in the synthetic biology community may be advocating for opensource biology, others such as Craig Venter have a long biopiracy record of profiting from human and non-human gene sequences. Because the science can be privatized and monopolized it becomes more attractive to companies seeking profit rather than addressing social needs.

The ETC group obviously defends the idea of a public concerned science, promoting external and exogenous control, regulation-building processes and decision making. That point is once again revealed in the Open Letter from Social Movements and other Civil Society Organizations to the Synthetic Biology 2.0 Conference (ETC 2006). The initiative of the Synthetic Biology 2.0 Conference in May 2006, was to mix up scientists from the field in order to write a «  "voluntary" code to prevent biosecurity risks ». The conference is criticized by ETC group and many other organizations (such as scientists, engineers, environmentalists, farmers, social justice advocates, trade unionists and biowarfare experts) because of the internal control promoted by the “voluntary” perspective and is compare to the Asilomar Conference of 1975.

Asilomar was conference about the ethics of emerging genetic engineering proposed by Paul Berg in 1975. Paul Berg was then about to insert a gene from the SV40 virus in Escherichia coli and decided to stop his research because of human health considerations. He decided to invite other scientists to a debate the ethical stakes of transgenese and to build up a moratorium. That initiative was only about scientists, no consensus was found for the moratorium and the conference was only able to propose some precautions, mainly focused on human health. Most of the criticism against the Asilomar 1975 Conference was about the scientists' lack of ecological and socio-economic concerns (regarding agriculture, patenting of genes and organisms, etc).

The critic from the ETC Group and the organizations of the civil society authors of the Open Letter is coming with a set of proposal in order to build a new governance of synthetic biology. In their view, the main problems and proposals are :

  • Society - especially social movements and marginalized peoples - must be fully engaged in designing and directing societal dialogue on every aspect of synthetic biology research and products. Because of the extraordinary power and scope of synthetic biology technologies, this discussion must take place globally, nationally and locally
  • Scientific self-governance doesn't work and is anti-democratic. It is not for scientists to have the determinant voice in regulating their research or their products
  • The development of synthetic biology technologies must be evaluated for their broader socio-economic, cultural, health and environmental implications not simply for their misuse in the hands of 'evildoers.'

We can end that reflexion about society and synthetic biology with something pointed by Kaushik Sunder Rajan in Biocapital (Rajan 2006). He analyzes how genomic companies are building ethical discourses, mostly focused on biosecurity concerns, as in the Report on Synthetic Biology Governance. Rajan shows, by quoting them, that ethical discourses pronounced by genomic companies seek legitimacy in slogans such as « saving life », « genomics for life », etc. Thus, companies are not only defending ethical statements and values in order to prove that they are responsible, they gradually become themselves “ethical entities”. The biosecurity problem allows discourses to be constructed about the “bad” and “malicious” , as opposed to them, the ethical company. To understand this, we refer to Michel Foucault’s concepts of “biopolitic” and “biopower” to consider how life can be used as a means to exert power and how power is now expressed on individual and collective life. In that light, bioterrorists use biological material to affect your life whereas genomic companies are at the service of your life, by defending and ameliorating it with individual biomedical consulting and by writing ethical reports. Life and its possible improvement through biotechnologies is now a fundamental concept in the constitution of a political and economical scene with huge stakes. The scale of genomic is now so precise that we are not talking anymore about life as an abstraction, a pure concept. Through genomic information, we are now talking about your individual life, as your life can be reached by bioterrorism, your life can be saved by genomic biomedical companies. Individualization is now biological through our genomic information. Our bodies, our health are now included in the individualism paradigm of our western societies, added to the political and economical individualism we are already used to.

C. Forms of critics

That brief presentation and reflexion about civil society proposal has to be deepened.

Indeed, the tone of such critics, although still legitimate to me, presents a quite simple image of what we call the “synthetic biologist”. Who is that scientist? Is every biologist like Craig Venter? Of course, the ETC Group is not so simplistic, some scientists are even very activist in such pro democratic science movements, but, I think we can use this conclusion to show how the youth of the discipline, already conceptually mentioned, is embodied in practices and scientists, and how because of new methods and ways, science is actually performed differently than what the Craig Venter Institute is promoting. The youth of the field offers the opportunity for actors to try out new ways to build knowledge, manipulation, place of science, criticism, etc.

It is above all a way to check out what kind of internal critics are made. That critics are both obvious, claimed as different practices by groups such as Do It Yourself movements, than something more softly performed in everyday science making process.

DIY practices are, to me, highly critical. By leaving academic laboratories, by building (both conceptually and materially) new kinds of experimental places, new tools, new ways of communication between scientists and open to non scientists participation, DIYists are clearly performing something new, which gives other aim to the science process. From a narrow perspective, science could be regarded, amongst other characteristic, as a way to build knowledge, technique and technology. DIYists consider science as a social activity thus changing radically the standpoint we can have on it. That way, science is regarded as something in which you can find personal achievement, in contrast to the more traditional perspective where the scientist is erased in the process of knowledge construction. Science as an activity, as a hobby, as a way to find fulfillment, changes, as a logical consequence, who will be involved and concerned by such practices.

The logic is quite simple: when science is about creating knowledge, not for yourself as a person (in a learning process) but in order to contribute to the whole system of knowledge, your aims, concerns and perspectives will be different. Of course with social studies of science, we already noticed that human and social factors are involved in the scientific process. There is nothing such as a pure scientific mind. But, the discourses about “why do we make science?” are mostly lead by such participation to a whole system of knowledge. That way, the traditional scientist’s aim is to contribute to a big ensemble, transcending their own work, their own person, even their own discipline. However, if we look at science as an activity, you can answer the question with something like : “making science to have fun” or “to build knowledge from scratch, in a garage or a kitchen”. That way, non scientists can be welcomed by DIY communities, and such aims can be imagined as something to be shared by everyone. That openness to non scientists, now called “amateurs” (motivated but uninitiated people) allow us, in my opinion, to link DIY perspectives with critical discourses, such as that from ETC Group. Regarding decision making, local practices, and the aims of science, DIY is obviously open to the democratic perspective defended by ETC Group. More deeply, some of their concerns are claimed by DIYists as aims. In that way, the website presented themselves as “an organization dedicated to making biology an accessible pursuit for citizen scientists, amateur biologists, and DIY biological engineers who value openness and safety. This will require mechanisms for amateurs to increase their knowledge and skills, access to a community of experts, the development of a code of ethics, responsible oversight, and leadership on issues that are unique to doing biology outside of traditional professional settings”.

As such, biology is then conceived and made as a set of social practices, open to both scientist and non scientist in order to answer to very different goals than traditional science: for example scientific skills, ethical reflexion, and new ways to cooperate are now integrated with the actual science goals.

This description doesn't have to lead us to consider that there are two worlds in synthetic biology, something like “Venter Institute versus DIY practices”. The portrait of the field of synthetic biology is much more complex : big companies, little start -ups, universities, institutional or associative organizations, movements, groups like DIYbio, etc. Everyone is pursuing both different and similar goals and a lot of ideas, discourses, practices and people are circulating in all spheres. We can view the IGEM competition as one such place (along with so many others) where people and practices from these different worlds can meet. The huge advantage of such an event is that it allows us to observe something like a cross section, or an extract of the whole picture permitting us to get stakes and debates clearer.

D. To finish with... A case study

But, events like IGEM are not only offering us a certain visibility, they are creating something and something more than the individual student projects.

As we mentioned with respect to opensource strategies in standardization, the IGEM competition is stimulating new practices, new “science spacetime”, for students : choosing their own subject, building their own team, dedicating their holidays to that program. In a certain way, IGEM is promoting something close to DIY practices : science is not only about courses and classes, it also seen as an innovative project, even if everything is done in a rush and hardly finished. The imperative use of the public wiki makes the competition very unusual and indirectly announces an open approach to science making. Summer and temporary labs aren't thought to be close to the world. Sharing, meeting, looking at other projects is encouraged. Some elements are new for students, such as the use of BioBrick™. In the same way, the “get some, give some” principle has to be integrated as a new way of making science, and, in addition to the standard using habits, free exchange between scientists is performed.

But this portrait has also to reflect the conflicts, so normal in projects of this kind. As an example, let's consider the attempt of participation of a DIY team in the IGEM 09 competition. On February 2009 DIYbio Groups had initiated the idea of a DIYIGEM team with a “home made project” and started to think about what they can propose, regarding their material conditions of work. Regarding posts written on DIYbio googlegroups, website and blogs, on April 10, the initiative was rejected by the IGEM's direction. Mackenzie Cowell from DIYbio, former student and researcher at the MIT and instructor for IGEM, related the official reasons for rejection in one of his post, quoted from Randy Rettberg, IGEM Director :

  • 1. “IGEM depends on the academic institution of each team to provide a safety framework for that team. Because there is no formal safety framework or guidelines or precedent for amateur teams working outside of traditional labs, IGEM is afraid of the potential safety liability and doesn’t want amateur teams to participate until there is some kind of framework (2010!).
  • 2. Most of IGEM’s funding comes from grants to support undergraduate education. A host of amateurs who are not undergraduates would be supported by grants for undergraduate education, which could be a situation the grantors wouldn’t like. Randy didn’t want to take that risk.”

We can see that concern over biosafety is called up by the IGEM Direction to reject the DIYIGEM proposal. The second point is a very different argument, putting into light how both youth and academic composition of teams are important to grantors.

Two important things follow the rejection: how the DIY community proposes to take strategic advantage of it and how IGEM 09 Competition answers.

If we keep going on the post, Mackenzie Cowell is proposing different things to react to the rejection. At first, the rejection seems to lead DIYists to challenge safety concerns for two reasons. At the same time, in order to endure in the field and to be well considered by society, these safety norms will have to be established. And once these norms are established, it will be a way for garage practices to be known and recognized as serious and responsible, rather than being seen as a security risk. Then, the post proposes a very local strategy to create something about its rejection: Mackenzie Cowell proposes to make a “DIYbio symposium at the same time and place as iGEM” and follows, “it would be very valuable to bring as much of the community together as possible to meet and discuss these issues and to present a collective snapshot of their work and projects to the world. There would be cross-pollination with many of the iGEM participants, and lastly, I’d like to use the symposium as a deadline by which some group or groups of people could formally present thoughts and work on our safety strategy to the community and to the rest of the world.”

As in traditional activism, the DIY movement knows that an innovative and quick reaction, even about a “bad news” can get round the problem and turn it to their own benefit.

The MIT reacteded, presumably to the pressure of DIY groups, by a surprising but small initiative. The IGEM 09 Competition will be the first to propose an “Open Division”.

On the IGEM 09 official wiki, you can find:

“For iGEM 2009 we will are opening up an experimental track for individuals or small teams that are interested in participating in iGEM in a limited capacity. These non-competition teams will have a chance to present a flash 5-minute presentation and present a poster at an exposition section of the iGEM 2009 Jamboree on October 30 - November 2, 2009. Non-competition teams will not be eligible for the standard prizes from the iGEM judging committee but might be eligible for a single award specific to non-competition teams.”

That way, MIT and the IGEM Direction are able to keep an image of openness to the participants, to DIY groups (which are mostly composed of very qualified biological engineers) and to grantors. Without making eligibility for global prizes and requiring teams to be “affiliated with a university or educational institution”, “have at least one faculty instructor” and reserving the right to give DNA on a case by case basis, MIT seems protected from “home made” projects.

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