March 2017.

Synthetic biology enables scientists to do experiments with biological systems that differ essentially from naturally occurring ones, which may no longer be the type of well-known and well-characterized organisms we have been dealing with so far. This calls for reconsideration of existing approaches in biosafety assessment. At the same time, several enabling tools such as gene editing techniques and bio informatics have resulted in a considerable increase in the speed of developing new technologies and applications, which makes it hard for risk assessors, risk managers and policy makers to keep pace. On top of that, the GMO debate has taught us that policies on controversial technologies require governance approaches that include safety as well as normative issues in the process of research and innovation.

To deal with this complex of issues in a dynamic societal and political setting in a responsible way, i.e. developing governance on safety and societal impacts along with developing new technologies and applications that may be beneficial for society, calls for assessment and management strategies that are adaptive.

The SYNENERGENE project aimed to contribute to the design of a learning process regarding such adaptive strategies that involves researchers, regulators, risk assessors, stakeholders as well as civil society with a workshop and interviews with experts in the field of synthetic biology and governance as well as stakeholders. This resulted in the "Adaptive Biosafety Assessment as a Learning Process - Strategy Paper". Since this strategy paper is meant to take the process of designing and testing adaptive risk assessment and risk management strategies a few steps further, it is freely available for download at this SYNENERGENE website, together with a working document that was used for preparation of a workshop, a report of this workshop and a report of a number of interviews with experts and stakholders. Strategy paper and annexes are available for download below.