Capability Approach and Inclusion: Developing a Context Sensitive Design for Biobased Value Chains.

Biomass such as crops and agricultural waste is increasingly used as the primary resource for products like bioplastics and biofuels. Incorporating the needs, knowledge, skills and values of biomass producers in the design of global value chains - the steps involved in creating any finished product from design to delivery - can contribute to sustainability, reliability and fairness. However, how to involve biomass producers, especially if they are resource poor, remains a challenge. To make sure that inclusion in global biobased value chains is both fair and effective, the capabilities of relevant actors need to be taken into account, especially of those producing biomass. Access to resources determines to what extent a specific actor can participate in a global value chain. Therefore, differences in capabilities should be a central consideration when new (biobased) value chains are designed. Using the capability approach as an ethical framework to realize inclusion, we discern three complementary strategies for setting up inclusive value chains. Firstly, designing for local conversion factors second, providing adaptive design for new capabilities, and third, investing in local conversion factors. Applying these strategies can lead to context-sensitive design of biorefineries that allow for true inclusion of local stakeholders. We support these claims with reference to case-studies of sugarcane production in Jamaica, modified tobacco in South Africa and the non-edible parts of corn (stover) in the US.

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.

Societal values, tensions and uncertainties in resource recovery from wastewaters.

The recovery of resources, including water reuse, has been presented as a solution to overcome scarcity, and improve the economic and environmental performance of water provision and treatment. However, its implementation faces non-technical challenges, including the need to collaborate with new stakeholders and face societal acceptance issues. Looking at the prominence of the circular economy in current policy developments and the challenges to resource recovery, exploring these issues is urgently needed. In this work, we reviewed a broad range of literature to identify societal values relevant to the recovery of water and other resources from wastewaters, particularly urban and industrial wastewater and desalination brines. We discuss tensions and uncertainties around these values, such as the tension between socio-economic expectations of resource recovery and potential long-term sustainability impacts, as well as uncertainties regarding safety and regulations. For addressing these tensions and uncertainties, we suggest aligning common methods in engineering and the natural sciences with Responsible Innovation approaches, such as Value Sensitive Design and Safe-by-Design. To complement Responsible Innovation, social learning with a Sustainability Transitions or Adaptive Governance perspective is suggested.

Safe-by-Design in Engineering: An Overview and Comparative Analysis of Engineering Disciplines.

In this paper, we provide an overview of how Safe-by-Design is conceived and applied in practice in a large number of engineering disciplines. We discuss the differences, commonalities, and possibilities for mutual learning found in those practices and identify several ways of putting those disciplinary outlooks in perspective. The considered engineering disciplines in the order of historically grown technologies are construction engineering, chemical engineering, aerospace engineering, urban engineering, software engineering, bio-engineering, nano-engineering, and finally cyber space engineering. Each discipline is briefly introduced, the technology at issue is described, the relevant or dominant hazards are examined, the social challenge(s) are observed, and the relevant developments in the field are described. Within each discipline the risk management strategies, the design principles promoting safety or safety awareness, and associated methods or tools are discussed. Possible dilemmas that the designers in the discipline face are highlighted. Each discipline is concluded by discussing the opportunities and bottlenecks in addressing safety. Commonalities and differences between the engineering disciplines are investigated, specifically on the design strategies for which empirical data have been collected. We argue that Safe-by-Design is best considered as a specific elaboration of Responsible Research and Innovation, with an explicit focus on safety in relation to other important values in engineering such as well-being, sustainability, equity, and affordability. Safe-by-Design provides for an intellectual venue where social science and the humanities (SSH) collaborate on technological developments and innovation by helping to proactively incorporate safety considerations into engineering practices, while navigating between the extremes of technological optimism and disproportionate precaution. As such, Safe-by-Design is also a practical tool for policymakers and risk assessors that helps shape governance arrangements for accommodating and incentivizing safety, while fully acknowledging uncertainty.

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.

Integrating Value Considerations in the Decision Making for the Design of Biorefineries.

Biobased production has been promoted as a sustainable alternative to fossil resources. However, controversies over its impact on sustainability highlight societal concerns, value tensions and uncertainties that have not been taken into account during its development. In this work, the consideration of stakeholders' values in a biorefinery design project is investigated. Value sensitive design (VSD) is a promising approach to the design of technologies with consideration of stakeholders' values, however, it is not directly applicable for complex systems like biorefineries. Therefore, some elements of VSD, such as the identification of relevant values and their connection to a technology's features, are brought into biorefinery design practice. Midstream modulation (MM), an approach to promoting the consideration of societal aspects during research and development activities, is applied to promote reflection and value considerations during the design decision making. As result, it is shown that MM interventions during the design process led to new design alternatives in support of stakeholders' values, and allowed to recognize and respond to emerging value tensions within the scope of the project. In this way, the present work shows a novel approach for the technical investigation of VSD, especially for biorefineries. Also, based on this work it is argued that not only reflection, but also flexibility and openness are important for the application of VSD in the context of biorefinery design.

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.

Societal and Ethical Issues in Industrial Biotechnology.

In this chapter we aim to give an overview of the main societal and ethical issues that are currently voiced around industrial biotechnology. We will illustrate this with some recent cases, such as the development of synthetic artemisinin, synthetic vanillin and vegetable oil produced by engineered algae. We show that current societal and ethical issues in industrial biotechnology centre on the following five themes: sustainability, naturalness, innovation trajectories, risk management and economic justice. In each of these themes, clashing public opinions fuel the public debate on the acceptability of new industrial biotechnology. In some cases this has led to the failure of otherwise promising innovations. In the last part, we provide suggestions on how to deal with these ethical and societal aspects based on the approach of Responsible Research and Innovation (RRI).

Creative tensions: mutual responsiveness adapted to private sector research and development.

The concept of mutual responsiveness is currently based on little empirical data in the literature of Responsible Research and Innovation (RRI). This paper explores RRI's idea of mutual responsiveness in the light of recent RRI case studies on private sector research and development (R&D). In RRI, responsible innovation is understood as a joint endeavour of innovators and societal stakeholders, who become mutually responsive to each other in defining the 'right impacts' of the innovation in society, and in steering the innovation towards realising those impacts. Yet, the case studies identified several reasons for why the idea of mutual responsiveness does not always appear feasible or desirable in actual R&D situations. Inspired by the discrepancies between theory and practice, we suggest three further elaborations for the concept of responsiveness in RRI. Process-responsiveness is suggested for identifying situations that require stakeholder involvement specifically during R&D. Product-responsiveness is suggested for mobilising the potential of innovation products to be adaptable according to diverse stakeholder needs. Presponsiveness is suggested as responsiveness towards stakeholders that are not (yet) reachable at a given time of R&D. Our aim is to contribute to a more tangible understanding of responsiveness in RRI, and suggest directions for further analysis in upcoming RRI case studies.

The Need for Governance by Experimentation: The Case of Biofuels.

The policies of the European Union concerning the development of biofuels can be termed a lock-in. Biofuels were initially hailed as a green, sustainability technology. However evidence to the contrary quickly emerged. The European Commission proposed to alter its policies to accommodate for these effects but met with fierce resistance from a considerable number of member states who have an economic interest in these first generation biofuels. In this paper I argue that such a lock-in might have been avoided if an experimental approach to governance had been adopted. Existing approaches such as anticipation and niche management either do not reduce uncertainty sufficiently or fail to explicitly address conflicts between values motivating political and economic support for new technologies. In this paper, I suggest to apply an experimental framework to the development of sustainable biobased technologies. Such an approach builds on insights from adaptive management and transition management in that it has the stimulation of learning effects at its core. I argue that these learning effects should occur on the actual impacts of new technologies, on the institutionalisation of new technologies and most specifically on the norms and values that underly policies supporting new technologies. This approach can be relevant for other emerging technologies.

Mass-vaccination programmes and the value of respect for autonomy.

Respect for autonomy is problematic in relation to public health programmes such as vaccination, as the success of such programmes depends on widespread compliance. European countries have different policies for dealing with objectors to vaccination programmes. In some countries compliance is compulsory, while in others objectors are exempted or allowed to enter the programme under specific conditions. In this paper I argue that the objectors should not be treated as a homogenous group as is done in the above-mentioned policies. Objectors have different arguments for not participating in vaccination programmes. Considering the value of respect for autonomy, some but not all of these arguments need to be accommodated by authorities. The concept of 'narrative autonomy' provides criteria to distinguish between tenable and untenable claims to the right to refuse vaccination. Narrative autonomy understands autonomy as essentially linked to identity, as this provides the moral framework with which we assess our first-order preferences. The above-mentioned concept of autonomy is derived from the concept of narrative identity as described by Marya Schechtman. She suggests that the application of the Articulation Constraint and the Reality Constraint enables us to establish the validity of personal narratives. Additionally, form and content features of identity, as proposed by Anthony Laden, will be used as criteria to establish the compatibility of the defectors' arguments with shared scientific and political values. Such compatibility is essential to accommodate respect for autonomy in the context of public health.