Limits of Knowledge and Tipping Points in the Risk Assessment of Gene Drive Organisms

Limits of Knowledge and Tipping Points in the Risk Assessment of Gene Drive Organisms

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Arnim von Gleich and Winfried Schröder,  Gene Drives at Tipping Points,  2020.

New challengesTipping point in the risk assessment of genetically engineered (GE) organisms are expected to emerge in the context of so-called ‘gene drives’. Based on a review of findings from current knowledge of GE organisms, it is concluded that the risk assessment of gene drive organisms intended for release into the environment will inevitably suffer from major uncertainties, ‘unknowns’ and methodological problems: subsequent generations of GE organisms might show effects that were not observed or intended in the first generation. Unintended effects can, for example, emerge from interaction with genetic backgrounds within natural populations or be triggered by changing environmental conditions. Due to the increasing spatio-temporal complexity associated with the long-term persistence and propagation of GE organisms, risk assessment can no longer be expected to produce sufficiently reliable results. It has to be assumed that at a certain point in the dissolution of spatio-temporal boundariesa tipping point will be reached, that will make reliable risk assessment impossible. Moreover, methodological problems need to be overcome: the comparative approach that is the starting point for current European Food Safety Authority (EFSA)European Food Safety Authority (EFSA)’s environmental risk assessment might not be applicable due to the lack of suitable ‘comparators’. Despite increasing uncertainties, riskassessors and risk managers need to solve the problems of how to come to robust conclusions and make reliable decisions that take the precautionary principle(PP) into sufficient consideration. The introduction of a new step in the risk assessment of genetically engineered organisms has been suggested to solve these problems—which is the ‘spatio-temporal controllability’ and takes three criteria into account:(1)the biology of the target organisms,(2)their naturally occurring interactions with the environment (biotic and abiotic),(3)the intended biological characteristics (traitsTraits) of the GE organismsGenetically engineered organism.