In the world of emerging technologies, perhaps one of the most significant events of 2010 was the announcement by Craig Venter in May that he had successfully created ‘artificial life’.  In response to this, President Obama asked his recently appointed Presidential Commission for the Study of Bioethical Issues to study the implications of synthetic biology. Before reaching any conclusions the Commission intended to consult with the broadest possible range of individuals and groups in order to gather various perspectives on the subject before publishing their findings and recommendations.

The Commission published its recommendation on the oversight of synthetic biology on 16th December. As one would have hoped, from the outset the report clarifies the true context of Venter’s breakthrough which is often missed and has somewhat been ‘over egged’ in the majority of media reports. The genome that was synthesized by Venter and this team was also a variant of the genome of an already existing species.  As such their breakthrough does not represent the creation of life; something which remains rather remote for the foreseeable future. Moreover, the Commission is said to have considered an array of approaches to regulation ranging from at one extreme allowing unfettered freedom with minimal oversight to the other of prohibiting experiments until they can be ruled completely safe beyond all reasonable doubt.

The future of regulation

For the purposes of this short article, I shall focus on the matter of regulation. In the words of the Commission’s report they chose a middle course to maximise public benefits while also safeguarding against risks. Conversely, critics argue that relying on industry “self regulation,” effectively means no independent oversight. Whilst these are understandable concerns and the appropriate groups have every right to express their opinions and concerns I am left questioning whether we are in danger of really missing the bigger picture concerning this new technology, preferring to use regulation and regulatory tools with an ‘old’ mindset as opposed to developing ‘new’ approaches to new technologies.

In many respects synthetic biology is very similar to nanotechnologies, as both have ‘bottom up’ enabling properties which cause their risk profiles to be profoundly unclear. A ‘low certainty, low consensus’ risk therefore emerges where the knowledge base is fairly thin concerning how and what could occur and a low level of consensus as to how, what and why we should do in response.

‘Open source’ biology

The tendency is therefore to shut everything down and keep a tight rein on things but this will inevitably shut down innovation and research which could help fill these knowledge gaps in order to better understand the technology. This is even more crucial when it comes to synthetic biology and what has been termed ‘open source’ biology.  As Carlson comments in his book “Biology is Technology”, regulation needs to be carried out in such a way so as to counter mistakes in the lab and weapons created from biological components and ideally make threats irrelevant before they become a problem. This idea is based on simply allowing access to the tools and skills necessary to participate in innovation which is driven not just by academia or existing corporations but “from people noodling around in their garages or in start-up companies yet to be founded”[1].

The Commission resonated with these thoughts in part, concluding that the field is likely to become more decentralised as the tools become increasingly available and affordable, hence rejecting calls for a moratorium on research because it would “inappropriately limit intellectual freedom”. Dubbed the ‘Do-It-Yourself’ community, the Commission recognises the important role it has in advancing synthetic biology by fuelling ‘garage based’ innovation, but equally believe that the expense and technical expertise to be too high for a completely novel organism to be developed in a non-institutional setting. This might be the case currently but what about the future?

With new technologies we need new models of regulation which bind and evolve with the technology as opposed to a ‘freeze frame’ approach which deals with the immediate but allows no room for future development, resulting in what has been termed regulatory ‘disconnection’.  

Low public awareness and polarised debates

Without doubt, some degree of governmental oversight and regulation is necessary in order to maintain public confidence in new developments which they know very little about, hence the typical distrust lack of support towards proposals for self regulation.  Surveys reveal that over 80 per cent of people have heard nothing or very little about developments such as synthetic biology. “If people learn that technology risk management is substantially voluntary at the same time they first learn about a technology, public concern would be expected to increase rapidly….The combination of low public awareness and polarising debates presents a challenging landscape for the socially-appropriate development of nascent technologies”[2]. The timing of the Commission’s report (within months of the public probably encountering synthetic biology for the very first time) and the critical response to its recommendations stands only to serve as a stark example of this statement.

Therefore, like Mandel, I believe that rather than pursuing an overhaul of existing regulation or calling for a moratorium (which to be fair the Commission has not called for, but critics in response have) the situation we find ourselves in offers the opportunity to embrace scientific uncertainty and regulatory disruption rather than avoid it.  Whilst serious factors, they nevertheless have the potential to draw together a diverse range of stakeholders together who share a common interest and desire to address them.  Uncertainty regarding the application of a technology gives rise to fear and concern among the public, regulatory agencies are faced with regulatory challenges and industry and business are faced with challenges to investment, development, innovation and the environment.

Whilst these parties may represent quite polarised perspectives on matters of risk, the potential is still there for them to work together on a framework which responds to new scientific information as it is released. Those parties who believe that the technology presents key risks can be satisfied that room is given for the risks to be identified and an appropriate framework established in response. Those who perceive the technology to be largely risk free are satisfied because they believe no major issues will be uncovered and that research and development in this area can continue and not be prohibited.  

Having acknowledged the need for long term thought and engagement with these types of question, this proposal by Mandel certainly glides effortlessly over the intricacies of arranging and establishing such a framework. Nevertheless, like him, I believe that this must be a far more productive approach to take as opposed to assuming the more usual polarised debate or for and against which often leads to serious drain in resources.  Initiating such a move in the early stages – what some have termed ‘upstream engagement’ – can further aid the success of creating new forms of governance.

A new model

Mandel goes on to propose a new government model which concerns six key areas[3]: (1) improving data gathering and sharing in the face of limited resources (2) filling newly created or exposed regulatory gaps; (3) incentivising strong corporate stewardship beyond regulatory requirements; (4) enhancing agency expertise and coordination; (5) providing for regulatory adaptability and flexibility and (6) achieving substantial, diverse stakeholder involvement.

Briefly I shall compare the recommendations of the report to these six areas. First, Mandel addresses the need for data gathering which is probably the greatest challenge to any emerging technology, not least synthetic biology. However, it remains one of the key avenues through which to address and provide answers to some of pressing questions regarding new technologies and which in turn helps to further understanding. Incentives should also be incorporated into this model so that the research which takes place addresses the key questions. It has been recognised that questions surrounding exposure and risk are commonly under funded. This has certainly been the case in nanotechnology and is only just being corrected.

What I think is one of the great concerns with emerging technologies is the issue of asymmetry. Whether we fully realise the implications of, it could be that advances in new technologies will end up empowering people from the bottom up, not top down. On the one hand, this could well mean that it is all the more difficult to implement commercial or governmental control, creating a fresh take on democratic life in the global village. Conversely, it could also lead to asymmetry; enduring strife and conflict arising from a lack of coordination across disciplines and constituencies. Long term engagement is the key to this technology as it offers asymmetric tools that lie far beyond the imagination of former generations. Smart teenage bio-terrorists developing bio-weapons in their mum and dad’s garage could just be the tip of the iceberg. Thus any moves to promote data sharing and cross disciplinary activity is a good thing.

This in turn ties in with Mandel’s further areas of filling regulatory gaps and governance adaptability. Once again this points to the need for a framework which works now but which also have the flexibility to develop and allow incremental changes in government as the technology develops.  Whilst the Commission’s report intimates of the need for this it does not provide any initial proposals of how this could be taken forward.

An alternative to self regulation?

Mandel’s model also advocates a form of industry stewardship, or social responsibility on the part of business which would go a long way in helping to improve public confidence in not only the technology but also the role of business. This idea is more than just about transparency but advocates going beyond the absolute legal requirements and encouraging industry to pursue areas which are of yet unregulated, thereby increasing and enhancing the data being generated. Critics have argued that “self regulation” equates to “no regulation”. Citing the example of the annual synthetic biology conference in 2006 when attempts to write  a set of self regulations to protect the environment which helping to further work in this area failed. The reason for the failure was said to be due to biologists being more concerned with promoting research than on attempts at self regulation[4]. Mandel’s proposal provides a response to this in terms of a “mandatory back stop” setting the minimum requirements and upon which the industry can build upon. This to me sounds a significant and more conducive approach as opposed to ‘self regulation’.

Inter-agency and intra-agency expertise and co-ordination is also actively encouraged in Mandel’s model, thereby to fuse ideas and resources. Like, nanotechnology, synthetic biology is interdisciplinary in nature, thus networking and exchange of ideas and expertise in crucial in terms of long term development. The Commission’s report clearly acknowledges this and calls for the scientific community—in academia, government and the private sector—to work together to evaluate and respond to known and potential risks of synthetic biology as it evolves. In terms of international coordination on safety and security, the Department of State, in concert with the Department of Health and Human Services and the Department of Homeland Security, should collaborate with governments around the world, as well as leading international organizations, such as the World Health Organization to promote ongoing dialogue about emerging technologies like synthetic biology. Given the current economic climate and resource allocation being of prime importance surely such an approach is called for all the more.

In terms of stakeholder involvement, the need for this to be as broad as possible is crucial to new technology in order hear and reach decisions informed by as many as parties as possible. This brings with it the transparency and credibility which many of public interests are concerned with whilst mitigating issues centred on risk and safety. In the background to this, is the genetically modified foods debacle in the US and Europe which serves as a constant reminder how crucial this factor is and the need to get it right. In terms of the Commission’s report, there has been modest move towards broad stakeholder involvement but given the relatively short period of time given to gather evidence and present their report, how broad and detailed a spectrum of opinion it represents is doubtful. It is hoped that these initial moves firmly indicates the need for ongoing dialogue in this way as the technology develops.

Conclusion

Therefore, whilst the Commission’s report is perhaps a helpful start it could have been so much more. It has probably only highlighted issues which were already known and does not appear to bring anything new in terms of long term strategy as to how to address or navigate this new emerging field.  

The crucial question with synthetic biology, as with any new technology, is that at this early stage which kind of governance should be adopted and what steps can be taken to stay ‘connected’ to rapidly developing technologies?  The potential benefits of synthetic biology found in development of vaccines and new drugs and the production of biofuels that could someday reduce the need for fossil fuels, could be severely restricted and disrupted if the appropriate measures are not taken to help manage and develop the technology which unite responsibility with innovation.  At the same time synbio does present ‘scary’ (as used by synbio guru Drew Endy in an article in the New York Times) possibilities which I would be the first to acknowledge.  Putting to one side the hype and spin surrounding what Venter and his team have and have not achieved, one thing that does engender a broad sense of agreement is that it is significant and presents key questions concerning the future regulation and handling of technology. In turn, these questions demand serious long term consideration assessing the benefits and threats in parallel. Let the conversation continue!

[1] R.H. Carlson, Biology is Technology: The Promise, Peril and New Business of Engineering Life, (Harvard University Press, Harvard: 2010), p.211
[2] Gregory N. Mandel, “Regulating Emerging Technologies”, Law, Innovation and Technology Vol 1,1 (2009): 80
[3] Gregory N. Mandel, “Regulating Emerging Technologies”, Law, Innovation and Technology Vol 1,1 (2009): 82-83
[4] Open letter to the Presidential Commission from civil society groups, 16th December 2010, http://www.foe.org/sites/default/files/Letter_to_Commission_Synthetic_Biology.pdf