Abstract
In recent years, the interest in developing genetically modified microorganisms (GMMs), including GMMs developed by genome editing, for use in the environment has significantly increased. However, the scientific knowledge on the ecology of such GMMs is severely limited. There is also little experience at the hands of regulators on how to evaluate the environmental safety of GMMs and on how to assess whether they provide sustainable alternatives to current (agricultural) production systems. This review analyzes two different GMM applications, GM microalgae for biofuel production and nitrogen-fixing GM soil bacteria for use as biofertilizers. We assess the challenges posed by such GMMs for regulatory environmental risk assessment (ERA) against the background of the GMO legislation existing in the European Union (EU). Based on our analysis, we present recommendations for ERA and the monitoring of GMM applications, and in particular for the improvement of the existing EU guidance. We also explore whether existing approaches for technology assessment can provide a framework for the broader assessment of GMM applications. To this end, we recommend developing and implementing an evidence-based sustainability analysis and other methods of technology assessment to support decision making and to address broader societal concerns linked to the use of GMM applications in the environment.