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)

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)

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)

Based on fieldwork, this article highlights the unexpected effects of controversies about nanotechnology in France. These controversies stem in particular from a strong challenge to the field by civil society protests and criticism concerning environmental and health risks. One reason for this challenge is the specific difficulties in assessing the toxicity and ecotoxicity of nanomaterials. Civil society organizations have pushed for strictly controlling or stopping academic, industrial, or even basic research. They were not successful in this regard but their activities (...) prompted researchers to think about “safe by design” solutions and this led to new interdisciplinary cooperation. Furthermore, the uncertainty about the risks assessment resulted in a reconfiguration of the relationship between academic research and industrial companies. Researchers have become essential to the shaping of safe products. The risks of nanomaterials have thus been a driving force for new research and innovation practices. (shrink)