Emerging Risks in Synthetic Biology: From Defintions to Recommendations for Science and Policy

Between September 2014 and December 2015 the European Commission’s Scientific Committees (SCENIHR, SCCS, SCHER) and a group of external experts published three Opinions regarding the upcoming challenges to risk assessment... [ view full abstract ]

Between September 2014 and December 2015 the European Commission’s Scientific Committees (SCENIHR, SCCS, SCHER) and a group of external experts published three Opinions regarding the upcoming challenges to risk assessment posed by Synthetic Biology (SynBio). This Working Group was charged with the task to respond to a mandate on risk assessment of SynBio from the European Commission and to outline the research priorities in the field based on existing and future risks in the next decade. The first Opinion focused on a working definition of SynBio and surprised many observers in the field by generating a broad definition, in contrast to previously available definitions that explicitly rejected most of the usually cited “pseudo-criteria” (e.g., standardisation, modularisation, degree of artificialness, etc.) used to promote SynBio and distinguish it from other fields of biotechnology. The operational definition in Opinion I is: “SynBio is the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms.“ In the second and third Opinions, it was concluded that although current risk assessment methodologies are appropriate for assessing the potential risks of SynBio activities and products, several improvements are necessary including: 1) the support for the characterisation of the function of biological parts and the development of computational tools to predict emergent properties of SynBio organisms, 2) streamline and standardise the methods for submitting genetic modification data and genetic parts information to risk assessors, 3) encourage the use of GMOs with a proven safety record as acceptable comparators for risk assessment, 4) aim to ensure that risk assessment methods advance in parallel with the progress in SynBio, and 5) support the sharing of relevant information about specific parts, devices and systems with risk assessors. Additionally, currently available safety locks used in genetic engineering such as genetic safeguards (e.g., auxotrophy and kill switches) were deemed insufficiently reliable, because of mutation and positive selection pressure for mutants. The WG recommended a clear strategy for the analysis, development, testing and prototyping of applications based on new forms of biocontainment and additional layers of containment using orthogonal systems.