Responsible Learning about Uncertain Risks arising from Emerging Biotechnologies

The current regulatory regime regarding GMOs within the Netherlands and Europe does ensure safety but struggles in balancing this notion with innovation. In particular, the way the Precautionary Principle (PP) is operationalized in GMO legislation has resulted in a highly precautionary culture in which there is little room to conduct research with associated uncertain risks or uncertainties – it has resulted in a culture of compliance. Although the debate on how ‘new’ genetic engineering techniques such as CRISPR should be assessed in comparison to recently exempted techniques is ongoing within the European Union (EU), this might not have any consequences for GMO regulation at all. These issues do not only stifle innovation but also illustrate that the current regime is not resilient in dealing with emerging techniques. To break free from the impasse between safety and innovation, researchers should be able to learn what uncertain risks entail, for instance, through Safe-by-Design (SbD). The main question addressed in this thesis is: “How to create an environment that is suitable to learn safely and responsibly what uncertain risks associated with emerging biotechnologies entail?”. I conclude that to enable responsible learning by means of SbD, 3 conditions are needed; regulatory flexibility, co-responsibility and awareness. Thereby, SbD could be a suitable approach to arrive at responsible learning, given that the 3 conditions are met. If not, SbD provides guidelines to lower or mitigate known risks but fails to provide a step-by-step approach to gradually learn what uncertain risks entail. This will leave a knowledge gap between known and uncertain risks which stifles innovation and hinders risk management in ensuring future safety for people, animals and the environment.