Synthetic Biology and Genetic Engineering: Parallels in Risk Assessment

When introducing new technologies, or dealing with uncertain situations in general, risk assessment is an established methodology to systematically and reliably consider whether intended benefits are gained or whether unwanted adverse effects are likely to occur. The German Advisory Council on Global Change (WBGU) distinguishes different risk categories according to the probability and extent of any possible damage. Building on that, the Gene-Risk Research Consortium elaborated a hierarchical risk assessment approach to analyze possible impact of the cultivation of genetically modified organisms (GMO). This approach is also adaptable to risks involved in the development of synthetic life forms. Since the use of GMO affects different levels of organization addressed by different scientific disciplines and stakeholders, the potential risks of GMO cultivation have to be denoted as being systemic and require interdisciplinary as well as transdisciplinary co-operation. Synthetic biology can build on risk management solutions which have been established for the use of GMO—at least to the extent that comparable risk dimensions have to be covered. For both technologies, risk assessment has to consider a wide spectrum of cause-and-effect chains and the potential impact over long time spans and large areas of space. It must also consider potential self-dispersal and subsequent evolutionary processes in the ecosphere after intended or accidental release into open ecosystems. A holistic risk assessment approach to GMO was settled upon by applying the concept of emergent properties structuring possible effects for different levels of organisation considering that interactions on lower levels (molecules, cells, organisms) in composition are supposed to bring up new interaction types on higher levels (populations, ecosystems, landscapes, biomes). In comparison with this structured approach, the current legal regulations, as established in the EU, can be improved in coherence and systematization by the proposed approach, in particular with regard to different ecological and economic implications of GMO (and in parallel potential releases of synthetic organisms). This is especially relevant on the landscape level; for instance, as a comprehensive systematization of region-specific adverse effects on non-target organisms, complex coexistence issues related to different production systems or some social ecological topics. In conclusion, human intervention involving self-reproducing entities by means of genetic engineering, as well as development of new synthetic life forms, should always evaluate the complete set of causal interactions on all levels of physical, biotic and social organisation in order to minimise the probability of unintended, undesirable and even harmful effects as far as feasible through anticipative assessment.