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)

The growth of responsible innovation scholarship has been mirrored by a proliferation of RI definitions and practices, as well as a recognition of the importance of context for RI. This study investigates how researchers in the field of nanotechnology for food and agriculture define and practice RI, as well as what motivations they see for pursuing RI. We conducted 20 semi-structured interviews with nano-agrifood researchers from industry and academia in the USA, where we asked them to describe their RI definitions, (...) practices, and motivations. We analyzed the emergent themes from these interviews, including how the themes aligned with four prominent RI principles. We found that nano-agrifood researchers largely focused their descriptions of RI definitions, practices, and motivations around a narrow envisioning of the RI principle of anticipation — emphasizing product safety, efficacy, and efficiency. We also found noteworthy tensions surrounding the less frequently mentioned RI principles. For example, some researchers envisioned inclusion as a way to align products with industry interests while others saw it as a way to align products with the public good. Concerning motivations for RI, some researchers viewed RI as a way to protect one’s reputation and avoid lawsuits while others viewed it as a way to improve human well-being and solve societal problems. Given these findings, future efforts to foster RI within nano-agrifoods should promote discussions among researchers concerning what it means to responsibly innovate and what practices this could entail, particularly beyond ensuring product safety, efficacy, and efficiency. (shrink)

In this special issue we will investigate, from the perspective of agricultural ethics the potential to develop a Responsible Research and Innovation approach to agriculture, and the limitations to such an enterprise. RRI is an emerging field in the European research and innovation policy context that aims to balance economic, socio-cultural and environmental aspects in innovation processes. Because technological innovations can contribute significantly to the solution of societal challenges like climate change or food security, but can also have negative societal (...) consequences, it is assumed that social and ethical aspects should be considered during the R&I process. For this reason, the emerging concept of RRI calls for ethical reflection on the nature, scope and applicability of responsibility and innovation in innovation practices in general, and the way social–ethical issues can be applied and addressed in agriculture. (shrink)

Humans are powerful and clever, and also more ignorant than they know. As a result, they too often fail to acknowledge or even recognize their limitations, and are more arrogant than humble regarding their capabilities. Education that explicitly recognizes and addresses the context of science and technology, their inherent values and ethical implications and concerns, and their problematic as well as beneficial impacts can potentially rescue the human species from itself.

Safe-by-Design is an approach to engineering that aims to integrate the value of safety in the design and development of new technologies. It does so by integrating knowledge of potential dangers in the design process and developing methods to design undesirable effects out of the innovation. Recent discussions have highlighted several challenges in conceptualizing safety and integrating the value into the design process. Therefore, some have argued to design for the _responsibility_ for safety, instead of for safety itself. However, this (...) idea has not been developed further. In this article, we develop an approach to Safe-by-Design, grounded in care ethics, which builds on the idea of designing for responsibility and can deal with the complexity that is inherent to the conceptualization of safety. We describe five ways in which care ethics contributes to the conceptualization of Safe-by-Design: (1) It suggests the development of ‘circles of care’ in which stakeholders share the responsibility for safety; (2) it recognizes the importance of considering safety as something that is situated in the surroundings of a technology, instead of as a property of the technology itself; (3) it acknowledges that achieving safety is labour that requires an ongoing commitment; (4) it emphasizes that the way in which we relate to technology impacts its safety; and (5) it recognizes the role of emotions in assessing safety. All these elements combined lead to a broader understanding of safety and a philosophically more substantial and practically more appealing conceptualization of Safe-by-Design. (shrink)

Genetic engineering techniques (e.g., CRISPR-Cas) have led to an increase in biotechnological developments, possibly leading to uncertain risks. The European Union aims to anticipate these by embedding the Precautionary Principle in its regulation for risk management. This principle revolves around taking preventive action in the face of uncertainty and provides guidelines to take precautionary measures when dealing with important values such as health or environmental safety. However, when dealing with ‘new’ technologies, it can be hard for risk managers to estimate (...) the societal or environmental consequences of a biotechnology that might arise once introduced or embedded in society due to that these sometimes do not comply with the established norms within risk assessment. When there is insufficient knowledge, stakeholders active in early developmental stages (e.g., researchers) could provide necessary knowledge by conducting research specifically devoted to what these unknown risks could entail. In theory, the Safe-by-Design (SbD) approach could enable such a controlled learning environment to gradually identify what these uncertain risks are, to which we refer as responsible learning. In this paper, we argue that three conditions need to be present to enable such an environment: (1) regulatory flexibility, (2) co-responsibility between researchers and regulators, and (3) openness towards all stakeholders. If one of these conditions would not be present, the SbD approach cannot be implemented to its fullest potential, thereby limiting an environment for responsible learning and possibly leaving current policy behind to anticipate uncertain risks. (shrink)