Contribution of Enzyme Catalysis to the Achievement of the United Nations' Sustainable Development Goals.

In September 2015, the United Nations General Assembly established the 2030 Agenda for Sustainable Development, which includes 17 Sustainable Development Goals (SDGs) [...].

Uncertainties and uncertain risks of emerging biotechnology applications: A social learning workshop for stakeholder communication.

Emerging applications of biotechnology such as new genomic techniques may give rise to new uncertainties and uncertain risks. Particularly the increased complexity and limited knowledge of possible risks associated with these new techniques, make it currently impossible to perform an adequate environmental risk assessment. As a result, there is a risk that such techniques don't get beyond experiments demonstrating the proof of principle, stifling their further development and implementation. To break free from this deadlock, we must be able to learn what such uncertainties and uncertain risks entail, and how they should be assessed to ensure safe further development. To shape a responsible learning environment to explore uncertainties and uncertain risks, we have organized five stakeholder workshops. By means of a case about the genetic engineering of plants' rhizosphere-an application abundant with uncertain risks-we identified tensions between different stakeholder groups and their different estimates of uncertainties and uncertain risks. Based upon derived insights, we developed a tool-a script for researchers to organize a stakeholder workshop-that enables a constructive discussion about emerging risks with a broad range of stakeholders. Thereby, the script provides a step-by-step approach to identify uncertainties, develop anticipatory strategies and adaptations in (experimental) research designs to lower or mitigate the earlier identified uncertainties, and helps to identify knowledge gaps for which (additional) risk research should be set up.

Responsible Learning About Risks Arising from Emerging Biotechnologies.

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.

Value Conflicts in Designing for Safety: Distinguishing Applications of Safe-by-Design and the Inherent Safety Principles.

Although both the Inherent Safety Principles (ISPs) and the Safe-by-Design (SbD) approach revolve around the central value of safety, they have a slightly different focus in terms of developing add-on features or considering initial design choices. This paper examines the differences between these approaches and analyses which approach is more suitable for a specific type of research-fundamental or applied. By applying the ISPs and SbD to a case study focusing on miniaturized processes using Hydrogen Cyanide, we find that both approaches encounter internal value-conflicts and suffer from external barriers, or lock-ins, which hinder implementation of safety measures. By applying the Technology Readiness Levels (TRLs), we gain insight in the matureness of a technology (thereby distinguishing fundamental and applied research) and the extent of lock-ins being present. We conclude that the ISPs are better able to deal with lock-ins, which are more common in applied research stages, as this approach provides guidelines for add-on safety measures. Fundamental research is not subject to lock-ins yet, and therefore SbD would be a more suitable approach. Lastly, application of either approach should not be associated with a specific field of interest, but instead with associated known or uncertain risks.

Safe-by-Design: Stakeholders' Perceptions and Expectations of How to Deal with Uncertain Risks of Emerging Biotechnologies in the Netherlands.

Advanced gene editing techniques such as Clustered Regularly Interspaced Short Palindromic Repeat (CRISPR)/Cas have increased the pace of developments in the field of industrial biotechnology. Such techniques imply new possibilities when working with living organisms, possibly leading to uncertain risks. In the Netherlands, current policy fails to address these uncertain risks because risk classification is determined process-wise (i.e., genetically modified organism [GMO] and non-GMO), there is a strong focus on quantifiable risks, and the linearity within current governance (science-policy-society) hinders iterative communication between stakeholders, leaving limited room to anticipate uncertainties at an early stage of development. A suggested concept to overcome these shortcomings is the Safe-by-Design (SbD) approach, which, theoretically, allows stakeholders to iteratively incorporate safety measures throughout a technology's development process, creating a dynamic environment for the anticipation of uncertain risks. Although this concept originates from chemical engineering and is already widely applied in nanotechnology, for the field of biotechnology, there is no agreed upon definition yet. To explore the possibilities of SbD for future governance of biotechnology, we should gain insight in how various stakeholders perceive notions of risk, safety, and inherent safety, and what this implies for the applicability of SbD for risk governance concerning industrial biotechnology. Our empirical research reveals three main themes: (1) diverging expectations with regard to safety and risks, and to establish an acceptable level of risk; (2) different applications of SbD and inherent safety, namely, product- and process-wise; and (3) unclarity in allocating responsibilities to stakeholders in the development process of a biotechnology and within society.