Investigating the biosafety and riisk assessment needs of synthetic biology in Austria and China

Fast becoming one of the most dynamic new sciences and engineering fields, synthetic biology has the potential to impact many areas of society. Synthetic biologists may use artificial molecules to reproduce emergent behaviour from natural biology, with the goal of creating artificial life or seek interchangeable biological parts to assemble them into devices and systems that function in a manner not found in nature. Approaches from synthetic biology, in particular the deliberate synthesis of complex, biological systems, have the capacity to change the way we approach certain key technologies and applications in biomedicine (e.g. in-vivo synthesis of pharmaceuticals, vectors for therapy), biochemistry (e.g. extension of the genetic code, non-natural proteins, bio-orthogonal reporters), environment (e.g. bioremediation, GMO biosafety), energy (bio-hydrogen production), or materials science (e.g. for information technology, biosensors). Its potential benefits, such as the development of low-cost drugs or the production of chemicals and energy by engineered bacteria are enormous. There is, however, also the possibility of deliberate (security) or accidental (safety) damage to humans, agriculture or the environment. Most comments and papers on potential risks of synthetic biology from the US focus on security aspects (bioterrorism). We think, however, that it is necessary to start focusing on the safety issues involved, especially when keeping in mind the negative public reactions towards GMOs in Europe. This is why we foresee that concerns in Europe and possibly China - in contrast to the US - could focus more about safety issues than security issues of synthetic biology. In order to ensure a vital and successful development of this new science and technology field it is absolutely necessary to gather information about these risks and to devise possible strategies to minimize them. In this project we aim to analyse the current developments in synthetic biology and its different subfields, with a special focus on those ongoing in (central) Europe and China. Based on this analysis we will review current biosafety regulations to find out to what extend they can handle the latest cutting-edge developments of synthetic biology and their potential applications. Finally we will prepare our conclusions and recommendations on how to improve existing biosafety and risk assessment frameworks in order to safely handle the next generation biotechnologies spearheaded by synthetic biology.

The new field of synthetic biology can be understood as the attempt to make biology easier to engineer. This includes the design of genetic information (DNA) on the computer which can then be produced synthetically in the lab, the construction of so-called genetic circuits - a similar concept as in electronic circuits - that enable microorganisms to complete specific tasks (such as the production of pharmaceuticals or biofuels), and the development of biological systems that are not found in nature (e.g. an alternative genetic code). Although it is still early days in the research and development of synthetic biology, a number of questions have been raised for science and society that we addressed in our project: What are the safety implications and potential unintended consequences of these newly engineered biological systems? Which new security issues are raised in terms of bioterrorism? Are current regulations and guidelines, made for genetic engineering, sufficient to deal with synthetic biology? If not, how could these regulations be improved? What happens if people outside traditional biotechnology institutions (Universities, commercial research labs) start to use synthetic biology, as is the case with the growing community of amateur or do-it-yourself (DIY) biologist? Can synthetic biology itself contribute to an even safer way to do biotechnology by introducing novel safety devices and concepts? Since most of the efforts in synthetic biology have taken place on a global scale (USA, Europe, Japan, China) it makes sense to investigate the societal aspects of synthetic biology from a global perspective. Our project was unique as it enabled the collaboration between an Austrian and a Chinese research organisation to tackle the questions mentioned above together.In the course of our project activities we described (upcoming) gaps in the regulation of a synthetic biology, such as the limited applicability of current risk assessment methods to synthetic biology and hence the need to develop improved forms of risk assessment. We examined the challenges and opportunities synthetic biology presents to toxicology. We also looked into the strategies that would protect society from misuse of synthetic biology, e.g. the synthesis of viral pathogens, while allowing the use of this technology to contribute to societal wellbeing. Another focus of our work was to study the role of new players (amateur biologists), their capabilities and motivation to use synthetic biology outside traditional biotech venues. Finally we investigated the opportunities to develop novel forms of biocontainment to prevent biological accidents by using different biochemical substrates in novel forms of life that would act as a kind of genetic firewall (comparable to computer security systems) preventing exchange of genetic material between natural and engineered (micro)organisms.