Synthetic biologists design and engineer organisms for a better and more sustainable future. While the manifold prospects are encouraging, concerns about the uncertain risks of genome editing affect public opinion as well as local regulations. As a consequence, biosafety and associated concepts, such as the Safe-by-design framework and genetic safeguard technologies, have gained notoriety and occupy a central position in the conversation about genetically modified organisms. Yet, as regulatory interest and academic research in genetic safeguard technologies advance, the implementation in (...) industrial biotechnology, a sector that is already employing engineered microorganisms, lags behind. The main goal of this work is to explore the utilization of genetic safeguard technologies for designing biosafety in industrial biotechnology. Based on our results, we posit that biosafety is a case of a changing value, by means of further specification of how to realize biosafety. Our investigation is inspired by the Value Sensitive Design framework, to investigate scientific and technological choices in their appropriate social context. Our findings discuss stakeholder norms for biosafety, reasonings about genetic safeguards, and how these impact the practice of designing for biosafety. We show that tensions between stakeholders occur at the level of norms, and that prior stakeholder alignment is crucial for value specification to happen in practice. Finally, we elaborate in different reasonings about genetic safeguards for biosafety and conclude that, in absence of a common multi-stakeholder effort, the differences in informal biosafety norms and the disparity in biosafety thinking could end up leading to design requirements for compliance instead of for safety. (shrink)

Safe-by-Design (SbD) is a new concept that urges the developers of novel technologies to integrate safety early on in their design process. A SbD approach could—in theory—support the development of safer products and assist a responsible transition to the bioeconomy, via the deployment of safer bio-based and biotechnological alternatives. Despite its prominence in policy discourse, SbD is yet to gain traction in research and innovation practice. In this paper, we examine a frequently stated objection to the initiative of SbD, namely (...) the position that SbD is already common practice in research and industry. We draw upon observations from two case studies: one, a study on the applicability of SbD in the context of bio-based circular materials and, two, a study on stakeholder perceptions of SbD in biotechnology. Interviewed practitioners in both case studies make claims to a strong safety culture in their respective fields and have difficulties differentiating a SbD approach from existing safety practices. Two variations of this argument are discussed: early attentiveness to safety as a strictly formalised practice and early attentiveness as implicit practice. We analyse these perceptions using the theoretical lens of safety culture and contrast them to the aims of SbD. Our analysis indicates that professional identity and professional pride may explain some of the resistance to the initiative of SbD. Nevertheless, SbD could still be advantageous by a) emphasising multidisciplinary approaches to safety and b) offering a (reflective) frame via which implicit attentiveness to safety becomes explicit. (shrink)