By Eleonore Pauwels

Thirty years ago, Waclow Szybalski and Anna Marie Skalka stated that new developments in science had given birth to an era of 'synthetic biology' which extends beyond simple analysis and description of existing genes to the design of novel gene assemblies. [1] Science has finally caught up with their predication. Synthetic biology differs notably from genetic engineering by synthesizing and using biological parts and systems that do not occur in nature. A series of developments in DNA synthesis, sequencing technologies and the ability to design and engineer biological circuits that could produce complex behaviors, have enabled the advent of synthetic biology.

This new technology is now at the forefront of what the National Science Foundation has termed "converging technologies," which includes bio, info, nano, and cognitive sciences. A lot of innovation will occur in the interstitial or "white" spaces between these disciplines, but this emerging multi-disciplinary smorgasbord will provide several challenges, mainly in terms of the ability for new fields to regulate their own actions, anticipate unintended consequences, communicate effectively with each other and the public, and solve what some political scientists term "collective action" problems. There will likely be new challenges in managing ethical, social, and legal issues at the boundaries between disciplines. This clearly echoes the early hopes and fears raised by nanotechnology, another "converging technology," whose emergence went hand in hand with an array of publicly funded research activities into its ethical, legal and safety implications.

Synthetic biology has the potential to play a key role in local economic development over the coming decades. A new wave of scientists and engineers are learning how to design and construct microorganisms from the ground up, by applying engineering principles to biology. Although the technology is in its infancy—with clusters of bio-engineering activities in the Boston technology corridor and the Silicon Valley [2] —advances in genetic recoding are beginning to enable researchers to program microbes to produce chemicals ranging from biofuels to medical drugs.

Yet the future of synthetic biology is far from certain. As an innovative and potentially disruptive technology, there are question concerning the safety, security and social acceptability of synthetic biology that must be addressed if it is to succeed. Charting a path forward that nurtures innovation while avoiding very real safety, security and ethical pitfalls, will require smart policies and broad partnerships amongst stakeholders. The global synthetic biology community has been engaged in discussions over safety and security from the beginning, but if the benefits of this new technology are to be fully realized without creating a legacy of harm, more effort is needed. This includes further research on potential environmental and human health risks and better public engagement.

Broader public engagement on the sensitive societal implications of synthetic biology should begin now. As shown by the 2008 poll, "Awareness of and Attitudes towards Nanotechnology and Synthetic Biology", the American public is unaware of synthetic biology, with about 9 in 10 adults saying they have heard a little or nothing at all about it. [3] Despite this lack of awareness, a two-thirds majority was willing to express an initial opinion regarding the tradeoff between potential risks and benefits of synthetic biology.

Certainly, the promises of synthetic biology are startling. For example, synthetic organisms can be used to create new and inexpensive pharmaceuticals, and to convert cellulose into sustainable biofuels. A 2009 poll, also conducted by Peter D. Hart Research Associates, confirms that communication about potential applications of synthetic biology can be a decisive factor in shaping its public perception. [4] This survey showed that over half of U.S. adults supported research on synthetic organisms to develop more efficient biofuels.

Questions remain, however, about the potential risk of synthetic biology. A new microbe that synthesizes a life-saving drug will be a hard sell if it also presents new environmental hazards or could be used to develop the next generation of bio-weapons. In addition, it is still unclear how people will respond to a technology that potentially enables scientists to create new living organisms from scratch. For instance, Hart's 2009 poll found that nine in ten Americans think that the public should be better informed about this type of research. More crucially, perhaps, 30% of U.S. respondents consider it morally wrong to create artificial life, and 30% are concerned about the potential misuse of synthetic organisms.

Indeed, there are serious social, ethical and safety concerns surrounding synthetic biology. It is the classic double-edged sword: this new technology could be used to create virulent pathogens or wean us from fossil fuels. By its very nature and goals – applying engineering to the biological world in order to develop complex synthetic microorganisms – synthetic biology challenges our approaches to oversight and regulation. The novel properties exhibited by synthetic biology-derived microorganisms can underpin innovation but also present new levels of uncertainty while assessing potential health and environmental risks.

In addition, some observers have described the synthetic biology community as having some of the qualities of a "hacker culture," probably due to the preponderance of engineers and computer scientists that have crossed disciplinary lines to enter this field. This raises an additional concern of whether someone could create a real and potentially deadly virus, rather than a computer virus, just for the "bragging rights."

Beyond these biosafety and biosecurity concerns, scholars from diverse disciplines and sectors who study the implications of new technologies increasingly discuss the social and ethical implications of synthetic biology. Are synthetic biologists playing God? How does this new engineering science test our conceptions about life, nature and the order of things? What is the impact of the engineering community and its collective practices on social or biological systems? As an innovative and potentially disruptive technology, there are question marks all over the social benefits of synthetic biology that will need answers and dialogues with citizens and societal actors if it is to succeed.

In conclusion, synthetic biology is evolving in the shadow of public con- sciousness – a situation that may serve the short-term interests of the research community, but not the long-term interests of society. It is unlikely that more than a small per- cent of the public have even heard the term synthetic biology, as shown by the aforementioned quantitative and qualitative studies commissioned by the Wilson Center. This lack of public awareness and engagement sets the stage for what some have termed the "Surprise of Dolly" problem (which refers to the appearance of the cloned sheep, Dolly, in 1997). "Without prior discussion of ethical issues, the gen- eral public cannot develop a frame- work or common language to discuss acceptable uses of a new biomedical technology, or even whether it should be used at all." [5] Public backlash against synthetic biology is a real possibility and could compromise the development of valuable applications resulting in the loss of economic and social benefits.

Eleonore Pauwels is Research Fellow with the Synthetic Biology Project Science, Technology and Innovation Program, Woodrow Wilson International Center for Scholars.

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